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Medical Waste Guidelines By State



December 8, 2021



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Medical Waste Guidelines By State

Medical Waste Disposal Guidelines by State. Medical waste, also called infectious waste, or biohazardous waste (such as blood, body fluids, and human cell lines), is waste contaminated with potentially infectious agents or other materials that are deemed a threat to public health or the environment.

Potentially Infectious Material is defined by the OHSA Bloodborne Pathogens Standard as:

When dealing with medical waste, it is important to follow proper handling regulations as per the Occupational Exposure to Bloodborne Pathogens Standard.

The 1991 OSHA standard was created to protect healthcare workers and occupations that put them at risk of exposure to bloodborne pathogens. The standard includes:

Development of an Exposure Control Plan. Employer written program that details the protective measures that the employer will take to decrease employee exposure to blood and any infectious items including biohazardous waste.

Personal protective equipment (PPE).  Any staff member that risks potential exposure to blood or biological fluids will be supplied with and should wear PPE such as gloves, full bodysuits, booties, and respirators.

Training for employees. All personnel with occupational exposure to biohazardous waste should receive initial and annual training. The training includes identifying medical waste, handling, and proper disposal of biohazardous waste.

Communication of biohazardous materials to employees. A biohazard warning label must be included on every bag or container of medical waste.

Mandatory Hepatitis B vaccinations. All employees that may be exposed to biohazardous waste will receive a Hepatitis B vaccination and employer will bear the cost.

What Is Biohazardous Waste?

According to Fred Hutchinson Cancer Research Center, Biohazardous waste, also called infectious waste or biomedical waste, is any waste containing infectious materials or potentially infectious substances such as blood. Of special concern are sharp wastes such as needles, blades, glass pipettes, and other wastes that can cause injury during handling.

The Importance of Proper Waste Disposal Guidelines

In order to ensure that regulated biohazardous materials are disposed of properly and safely, there are regulations for proper disposal by state. These regulations define how to collect, store, transport, and dispose of waste by type and how often biohazards need to be disposed of and/or length of time onsite, and more.

If you live in Illinois or California, your biohazardous waste should be stored as medical waste and no longer than 30 days onsite. Some states may require temperature-controlled storage, which usually lengthens the time for onsite storage.

Regulation of Medical Waste

All states have regulations for medical waste, but not all regulations are the same. Regulations vary by state and the type of disposal site (e.g., autoclave, incinerator, etc.). Find out what regulations your state has in place below.

The Centers for Disease Control and Prevention (CDC) recommend that anyone handling or disposing of medical biohazardous waste should be trained on how to do so. The CDC recommends training courses on biohazardous waste management for healthcare workers, emergency responders, law enforcement officers, public health officials, occupational safety and health practitioners, hazardous materials handlers, crime scene clean-up personnel, and others who may come into contact with biohazards on a regular basis.

 Medical Waste Guidelines by State

Steps for disposing of medical waste vary by state. It is important that the guidelines for your state and county be followed to avoid any possible negative consequences. The following lists the states and their respective guidelines for medical waste. Always check your current regulations by calling Healthcare Waste Management or your local EPA office to ensure compliance with current laws and regulations.

Alabama Medical Waste Regulations

Below are some of the highlights of Alabama’s Medical Waste Regulations. This is not an all-inclusive list, always check with the ALABAMA DEPARTMENT OF ENVIRONMENTAL MANAGEMENT for a current and all-inclusive list.

Alabama Generators of Medical Waste

Within 90 days from the effective date of this Division, each generator shall prepare, maintain, and update as necessary a written plan to ensure proper management of medical waste. This plan must be made available to the Department upon request. This plan shall address the following if applicable to the generators:

 (a) The type of medical waste generated.

 (b) Proper segregation, packaging, and labeling procedures of

untreated medical waste intended for off-site transportation.

 (c) Treatment method to be utilized on-site.

 (d) Transporter of any untreated medical waste transported off-site.

 1. Name, address, and telephone number of a responsible person.

 2. ADEM permit number.

 (e) Storage facilities utilized both on-site and off-site.

 1. Name, address, and telephone number of a responsible person for all off-site storage facilities.

 2. ADEM permit number for all off-site facilities.

 (f) All treatment/processing facilities utilized.

 1. Name, address, and telephone number of all facilities.

 2. ADEM permit number for all off-site facilities.

 (g) All disposal facilities utilized.

 1. Name of disposal facility as it appears on their permit.

 2. Permittee of disposal facility.

 3. ADEM permit number.

 (h) Frequency medical waste is removed off-site from medical waste generator’s facility.

 (i) Training of employees

 1. Steps that will be taken to minimize the exposure of their employees to infectious agents.

 2. Name of the individual who is responsible for training.

 (2) Each generator shall notify the Department in writing, within 90 days from the effective date of this Division. This notification shall address the following:

 (a) Name and mailing address of generator.

 (b) Name and telephone number of responsible people.

 (c) Street address, including nearest city, of generator’s facility.

 A person who will begin the generation of medical waste after the

effective date of this Division must submit the above notification and prepare a written Medical Waste Management Plan prior to initiating any waste generation, treatment, transportation, or disposal activity.

Alabama Collection of Untreated Waste

Collection of untreated medical waste intended for transport off-site, except where interment will be

utilized, shall be packaged, and maintained in the following manner.

 (1) The outermost layer of packaging for medical waste shall be packaged in containers which have either a red background color or utilize red lettering with contrasting background color and conspicuously labeled with either the words “Infectious” or “Medical Waste” or “Biohazardous” and/or contain the International Biological Hazard Symbol.

 (a) The wording shall be either printed on the container or securely attached by label on two or more sides. The wording shall utilize letters two inches or larger in size, and the International Biological Hazard Symbol, must be six inches or larger in diameter. The wording and symbol, if utilized, must be in a contrasting color to the background color.

 (b) The ink utilized must be indelible and considered permanent when exposed to the environment under normal weather conditions.

 (2) Containers shall be impermeable to moisture and shall have a strength which prevents ripping, tearing, or bursting under normal conditions of use.

 (3) Sharps shall be placed directly into leak proof, rigid, puncture resistant containers and sealed to prevent loss of contents under normal handling procedures. These containers shall be clearly labeled as described in

(1) above unless placed in rigid shipping containers that meet this requirement.

 (4) Small containers used to collect untreated medical waste placed inside larger containers to better facilitate storage, transportation, or disposal.

Small containers that will be placed into larger shipping containers shall meet the following requirements:

 (a) Containers used for sharps shall meet the requirements in paragraph 335-17-3-.01(3).

(b) All other containers shall utilize either a red background color or red lettering or Symbol which contrast with adjacent colors.

 (c) Wording utilized in paragraph 335-17-3-.01(1) shall be utilized. The wording shall be either printed on the container or securely attached by label on two or more sides. The wording shall utilize letters one inch or larger in size, and the International Biological Hazard Symbol must be three inches or larger in diameter.

 (5) The outermost layer of packaging must be properly identified with the following information. This information shall be securely attached or permanently printed and shall be clearly legible. Indelible ink shall be used to print the information on the label or container.

 (a) The name and address.

 (b) The date the waste was packaged in its outermost container.

 (c) One of the following words or phrases used in conjunction with

the International Biological Hazard Symbol: “Medical Waste” or “Biohazardous” or “Infectious.”

 (6) Containers of medical waste must remain intact without signs of leakage until treatment.

 (7) Containers of medical waste shall be handled in a manner that does not affect the integrity of the packaging.

 (8) Disposable single use containers used for the storage and transportation of untreated medical waste shall be rigid, leak resistant, puncture resistant, burst resistant, and tear resistant under normal conditions of handling and use. Reusable containers shall meet the preceding requirements in addition to being constructed of smooth, easily cleanable, impermeable materials and resistant to corrosion. If a fiberboard container is used, it shall meet the standards of 49 CFR 178.210 of the Code of Federal Regulations for a classified strength of at least 200-pound test and be marked DOT-12A65. All containers must be sealed prior to shipment. The maximum gross weight of fiberboard containers shall be 65 pounds.

 (9) Containers utilized for collection, storage and transportation shall be constructed of materials that are compatible with the treatment method to be utilized.

 (a) Single-use containers destined for incinerators shall be burnable.

 (b) Containers destined for steam sterilizers shall allow the waste to be treated at required temperature and pressure.

 (c) Reusable containers shall be decontaminated after each use with an approved treatment method.

 (d) Reusable containers shall not be used for other purposes unless

the following conditions are met:

 1. Containers shall be decontaminated by a method approved by the Department.

 2. All labeling, symbols or other identifications normally used to identify medical waste shall be removed.

 (10) Medical waste, such as liquids which are amenable to disposal by sanitary sewer, may be discharged subject to the following conditions:

 (a) Sanitary sewer system must provide secondary treatment.

 (b) Solid and liquid waste removed from systems which do not provide secondary treatment (e.g., holding tanks) must be further processed in a sanitary sewer system that provides secondary treatment. Prior approval for sewer systems not regulated by the Water Division of the Department must be obtained from the Local Health Officer.

 (c) Sanitary sewer system shall be operated in such a manner that medical waste will not bypass the treatment facility during normal operating conditions.

Alabama Storage of Untreated Waste

Persons engaged in the storage of untreated medical waste shall comply with the following. Storage as used in this rule would begin after a shipping container is prepared for shipment to a storage or treatment facility.

 (1) No person shall operate or maintain a facility for storage of untreated medical waste without a valid permit granted by the Department.

Storage facilities that are an integral part of the generator’s facility will not be required to obtain a permit.

 (2) Storage facilities shall be fully enclosed.

 (3) Designated storage facilities shall not be utilized for other purposes.

 (4) Surfaces of storage facilities which may come into contact with medical waste shall be constructed of smooth, easily cleanable materials that are impervious to liquids.

 (5) Storage facilities must be conspicuously identified with signs which contain either the phrase “Medical Waste,” “Infectious Waste,” “Biohazardous,” or display the International Biological Hazard Symbol.  

 (6) Storage facilities must be adequately secured to prevent entry of unauthorized persons.

 (7) Storage facilities must be operated in such a manner to minimize entry by rodents and vectors.

 (8) The operation of storage facilities must minimize or prevent objectionable odors as determined by the Department from migrating off-site.

 (9) If a container is damaged or leaking or improperly labeled, the storage facility may accept the container provided the damaged container is overpacked into another container or is properly labeled in accordance with the requirements of 335-17-3-.01(1).

 (10) Persons manually handling untreated medical waste at the storage facility shall wear impermeable gloves and protective clothing to minimize exposure.

 (11) Storage of untreated medical waste shall meet the following criteria:

 (a) Storage of medical waste by the generator shall not exceed seven calendar days from the date initial storage begins unless waste is refrigerated at a temperature less than 45 degrees Fahrenheit. This requirement shall not apply to generators who generate less than 220 pounds per month of medical waste.

 (b) Transportation of medical waste and subsequent storage prior to treatment shall be at temperatures less than 45 degrees Fahrenheit unless said transportation can be accomplished within in less than four hours.

 (12) The permittee or his designee shall allow inspection of the storage facility by Department Personnel during normal working hours.

 (13) The permittee shall maintain records as required by the Department for a period of three years. Records shall contain the following as minimum requirements:

 (a) The name and location of any generator or transporter who utilize the storage facility.

 1. Generators shall provide name and street address of business, name, and telephone number of a contact person.

 2. Transporters shall provide name and street address of business, name and telephone number of a contact person and list of any permits obtained for the transportation of untreated medical waste from a regulatory agency or.

 (b) The quantity of medical waste stored from each generator or transporter per month. The quantity may be recorded in tons, pounds, cubic yards, cubic feet, or gallons.

 (c) The date the waste was accepted from the generator or transporter for storage and the date it was removed from the storage facility.

 (d) The name and telephone number of a contact person for the transporter removing the waste to another facility and any permits which have been issued to that transporter.

 (e) The quantity of medical waste removed from the storage facility. The quantity may be recorded in tons, pounds, cubic yards, cubic feet, or gallons.

 (14) The Permittee of a medical waste storage facility shall prepare a Management Plan for the medical waste handled and stored at their facility.

Multiple locations covered by a single permit may be included in one overall plan if each facility is adequately addressed.

 (a) The Management Plan must address to the extent the information is applicable to the storage facility:

 1. The types of medical waste handled.

 2. Storage procedures that will be followed.

 3. Treatment facilities that will be utilized.

 4. Steps that will be taken to minimize the exposure of employees to untreated medical waste.

 5. Name of the individual responsible for the storage facility.

 (b) The Management Plan must be kept at the permittee’s principal place of business.

 (c) The Management Plan must be made available to the Department upon request.

 (d) The Management Plan must be updated as needed.

Arkansas Medical Waste Regulations

Arkansas Segregation of Medical Waste.

1. Medical waste must be segregated from other regular waste at the point of its generation in the producing facility.

2. Segregation of medical waste must be made into containers in compliance with the OSHA Bloodborne Pathogen Standard, 29 CFR 1910.1030. Containers (paper or plastic bags, metal or plastic rigid containers) meeting this standard must be closable and constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipment.

3. A non-sharps container (e.g., a step can) of medical waste shall be closed at all times except when actively receiving medical waste.

4. A sharps container with openings large enough to allow entry of any human hand shall be subject to any additional physical and/or administration controls necessary to prevent access by the public during normal conditions of use.

Arkansas Packaging and labeling of medical waste.

1. Medical waste, except for sharps capable of cutting or puncturing, shall be contained for reprocessing at the site of generation in collection containers impervious to moisture, which are leak resistant and have a sufficient strength to preclude ripping, tearing, or bursting under normal conditions of usage. Full containers shall be securely closed (fastened, taped, or tied) to prevent leakage or loss of solid or liquid wastes.

2. Contaminated sharps shall be packaged for reprocessing at the site of generation in containers that are leak resistant on the bottom and sides, rigid, closable, and puncture resistant. Sharps containers shall be assembled and utilized at all times as intended by the manufacturer. Sharps that have been treated and are still capable of cutting or puncturing must also meet this packaging requirement unless they have been rendered unrecognizable and are no longer capable of cutting or puncturing.

3. a. Warning labels shall be affixed to all bags and containers used for medical waste or affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. Labels must be water resistant and legible, colored fluorescent orange or orange red (or predominantly so), with lettering or symbols in a contrasting color, and include the universal biohazard legend.

b. Red bags or red containers shall be labeled as listed in VI.C. 3. a above.

c. Rigid containers for contaminated sharps and treated sharps as outlined in Section VI.C.2. shall be colored or labeled as listed VI.C.3.a. Treated sharps must also be labeled as in Section VI.C.3.a.

 d. Individual containers of medical waste that are placed in a labeled container as required in Section VI.E during storage, transport, shipment, or disposal are required to be labeled as listed in Section VI.C.3.a. Section VI.C.6 allows for the substitution of the 49 CFR Hazardous Materials Regulation’s labeling and packaging requirements during handling and transport of medical waste.

4. When medical waste leaves the facility where it was generated, the name and address of the generator must clearly be marked on the outside of the container. If the waste has been treated using an approved method as outlined in Section VI.F.1-6, then it must also be labeled on the container with the words “TREATED” and “BIOHAZARDOUS WASTE” or “INFECTIOUS SUBSTANCE” or “MEDICAL WASTE” or the universal biohazard symbol. Medical waste that has been treated by an approved method and determined by the Department as rendered unrecognizable, is not required to have special packaging or labeling when transported or disposed as outlined in Section VI.M. The handling and disposal of incinerator ash is regulated by the ADEQ.

5. Treated medical waste cannot be disposed of if it is in a red or orange-red bag or container as outlined in Section VI.C.3.b. and c. It must be further over packed in a different color container (e.g., brown, green, black paper or plastic) and then labeled as required in Section VI.C.4.

6. If medical waste requires labeling, packaging or management under the Code of Federal Regulations, Title 49, Parts 171, 172, 173, 177 and/or 178 of the Hazardous Material regulations, Title 29 Part 1910.1030 of the Bloodborne Pathogen standard or other federal regulations, as applicable, then the generator shall comply with the labeling and other applicable requirements specified in those regulations instead of as outlined in Section VI.C.3.a, b, and c.

7. Mechanical compaction of medical waste shall not be conducted prior to treatment and/or disposal, unless the mechanical compaction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated medical waste.

Arkansas Storage of Medical Waste

1. Medical waste packaged in disposable containers as described in Section VI.C.1 and 2 shall be placed in disposable or reusable pails, cartons, drums, dumpsters, or portable bins. Disposable and reusable systems shall be kept clean and rigid, be designed to prevent leakage of fluids, remain impervious to moisture, and be of sufficient strength to prevent tearing or bursting under normal conditions of use and handling and be kept sealed or closed to prevent leakage. The containers may be of any color and shall be conspicuously labeled as required in Section VI.C.

2. Storage of medical waste shall be in a manner and location which affords protection from unauthorized entry, animals, adverse weather conditions such as rain, snow, ice, sleet, hail, and wind, does not provide a breeding place or a food source for insects and rodents and minimizes exposure of employees and the public. When waste is not being actively placed in storage, the area must be secured.

3. The location of the medical waste in storage shall be conspicuously marked with signs which shall include the universal biohazard legend outlined in Section VI.C.3.a.

4. Storage time within the generating facility shall not exceed thirty (30) days once the container has been filled and closed. Storage of medical waste for longer than thirty (30) days must be approved by the Department. Filled containers of medical waste must be held at room temperature (72 degrees Fahrenheit (22 degrees Celsius)) or below in a secure location with limited access (unauthorized entry) as specified in Section VI.D.2. If the generating facility is unable to control odor from its stored waste, the Department may require more frequent removal and further limit the storage time.

Arkansas Transport of Medical Waste

1. Generators of medical waste may transport their own waste to an off-site permitted treatment or disposal facility, or satellite facility in a fully enclosed container designed to prevent leakage of fluids as outlined in Section VI.D.1., without having to obtain a transportation permit.

Generators that transport their medical waste shall keep a log of all medical waste transported. The log shall include the quantity, the date of transport and the name of the receiving facility. Logs shall be maintained on file at the generator’s facility for three (3) years from the date of shipment. Commercial medical waste transportation must comply with Section VII, requirements for transporters of commercial medical waste.

2. Medical waste transported off-site must be labeled as required in Section VI.C.

3. For transport purposes, the generator shall transfer custody of untreated medical waste only to a transporter who has obtained a valid Commercial Regulated Medical Waste Transportation permit from the Department as required in Section VII.A. The Department shall maintain a list of all permitted transporters. The list shall be made available by the Department’s Medical Waste Program.

4. The generator of medical waste shall maintain a log of all untreated medical waste transferred to a transporter that is permitted by the Department or a Department permitted treatment, storage and/or disposal facility. The log must include the quantity, the method used to determine the amount, the date the shipment was made and the name and permit number of the transporter or treatment/disposal facility. The logs shall be maintained on file at the generator’s facility for three (3) years from the date of shipment or transfer. If the information is listed on the manifest/tracking paper, then the manifest/tracking paper may be substituted for the log.

5. The generator shall obtain from the permitted transporter a signed receipt (manifest or tracking paper) for each shipment of medical waste. The requirements of the manifest/tracking paper(s) are listed in Section VII.K. These manifests/tracking papers shall be maintained on file at the generator’s facility for three (3) years from the date of shipment.

6. Medical waste cannot be transported in open vehicles or trailers. Tarped loads are not permissible.

7. Medical waste must be physically separated from other materials being transported.

8. Generators that transport large quantities of medical waste (not including commercial medical waste) must sign a letter of agreement provided by the Department ensuring procedures are in place that will assure the medical waste is managed during transport to protect the environment, the waste handlers, and the public health. (Large quantity is defined as fifty (50) pounds or more of medical waste transported in a calendar month.).

9. The U.S. Postal Service may be used to transport used and unused sharps for disposal. The generator must retain the original receipt and the returned registered or certified mail receipt. The generator shall retain the manifest/tracking paper for each shipment, and they shall be maintained on file at the generator’s facility for three (3) years from the date of shipment.

Arkansas Treatment of Medical Waste

1. Incineration – Burning of medical waste in conformance with the standards prescribed by the ADEQ or the EPA. A permit must be obtained from the ADEQ before an incinerator can be installed or operated. Inspection of incinerators shall be conducted by the ADEQ in compliance with the federal Clean Air Act and/or the Arkansas Water and Air Pollution Control Act, or other applicable air regulations.

2. Sterilization Technology – Sterilization is the complete elimination of microbial viability. Procedures utilized must be performed properly and according to the manufacturer’s operating instructions (with regard to time, temperature, pressure, waste exposure and capacity), provided the results changes the biological character or composition of the medical waste completely and reliably inactivating bacillus stearothermophilus spores or other appropriate organisms at a 4 Log 10 reduction (99.99%) or greater and meet or exceed the parameters listed below. If a primary container is used, the primary container shall be placed in the sterilization chamber with sufficient space provided between the chamber walls and the container to allow the steam, heat or chemical to surround the container and penetrate all of the medical waste. The primary container shall be sealed loosely enough to allow the steam to penetrate the entire contents of the container unless a self-venting bag is used. All the medical waste must be exposed to the temperatures and pressures listed below. Approved procedures are:

a. Steam under pressure (autoclaving) steam at 248 degrees Fahrenheit (120 degrees Celsius) at 15 pounds per square inch (psi) for thirty (30) minutes. Steam auger – steam at 205 degrees Fahrenheit (96 degrees Celsius) at 15 psi for sixty (60) minutes.

b. Dry heat – heat at 320 degrees Fahrenheit (160 degrees Celsius) at atmospheric pressure for two (2) hours.

c. Chemical vapor – approved EPA chemical mixture at 260 degrees Fahrenheit (127 degrees Celsius) at 20 psi for thirty (30) minutes; and d. Ethylene oxide – four (4) to five (5) hour cycle using eleven (11) to twelve (12) percent ethylene oxide. Chemical vapor and ethylene oxide sterilization may require an air permit from the ADEQ. Persons interested in applying this technology should contact the ADEQ before installing or operating such equipment.

Quality control of the sterilization process shall be performed at least once a month or after every forty (40) hours of operation, whichever comes later, using physical, chemical, and biological monitors (thermo chemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) placed in or on the outside of the waste containers and distributed throughout the load, chamber, or vessel during treatment as listed in Section VI.G to evaluate the effectiveness of the treatment process. Unless the sterilization unit is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, except for treatment using ethylene oxide, the operator of such sterilization equipment shall affix to the medical waste a temperature-sensitive tape which will indicate that the required temperature was reached.

3. Disinfection – a potential less lethal process compared to sterilization that eliminates or inactivates many or all pathogenic microorganisms including viruses, fungi, and bacteria (but not necessarily all their endospores) on inanimate surfaces. Approved procedures are:

a. Thermal Inactivation – procedure must be performed properly as indicated by the equipment manufacturer’s operating instructions and the adequacy of disinfection verified by physical, chemical, and biological monitoring (thermo chemical indicators and integrators such as autoclave tape, spore strips, ampoules, thermocouples, etc.) as listed in Section VI.G. Unless the thermal inactivation equipment is equipped to continuously monitor and record temperatures during the entire length of each disinfection cycle, the operator shall affix to the medical waste a temperature-sensitive tape (i.e. autoclave tape) which will indicate that the required temperature was reached.

Approved procedures are:

(1) Autoclave

(2) Microwave; and

(3) Dielectric energy.

Thermal inactivation must allow for sufficient heat to access and penetrate the waste. The waste must be packaged according to the recommendations of the manufacturer and loaded into the chamber as to not exceed the capacity limits set by the manufacturer.

b. Chemical – The use of EPA approved chemical agent to significantly reduce microbial activity for waste treatment, e.g., one (1) part freshly prepared solution of free available chlorine (hypochlorite bleach) concentration to no more than ten (10) parts water (1:10 dilution) for at least ten (10) minutes. The chemical agent shall be used according to the manufacturer’s instructions. The chemical agent must penetrate all the waste material. If liquid chemical disinfectants or sterilants are used, excess liquid must be drained prior to disposal. Certain chemical disinfectants or sterilants may not be allowed to be discharged to a POTW. Solid waste landfills are prohibited from accepting liquids or wastes containing free liquids and/or infectious waste as outlined in the ADEQ’s Solid Waste Management Code, Regulation 22.

4. Discharge of liquid or semi-liquid waste into the collection system of a publicly owned treatment works (POTW) – grinding and/or flushing of waste into a POTW within the generating facility, except as prohibited by the Department, the ADEQ or the superintendent/manager of the POTW.

5. Encapsulation – complete encapsulation of medical waste in a solid matrix (e.g., plaster of paris) which will significantly reduce the possibility of exposure.

6. Other available technology (alternate technology) – technology other than listed above in Section VI.F.1-5 shall be evaluated and approved by the Department. Alternate technologies are usually approved at the manufacturer level. Applications for approval of an alternate technology must be made on forms provided by the Department’s Medical Waste Program Criteria used to evaluate alternate technologies will include, but not be limited to:

a. Approval by states other than Arkansas that utilize a performance standards approach to review alternate treatment technologies.

b. Environmental impact.

c. Environmental permit requirements.

d. Potential worker health effects.

e. Manufacturer operating requirements and instructions.

f. Levels of microbial inactivation which includes:

(1) Inactivation of representative samples of mycobacteria, at a level of 6 log 10 (99.9999%) reduction or greater, as determined by the Department.

(2) Inactivation of Geobacillus stearothermophilus endospores or Bacillus atrophaeus endospores at a level of 4 log 10 (99.99%) reduction or greater, as determined by the Department. One or more representative surrogate microorganisms from each microbial group shall be used in treatment efficacy evaluations. The Department shall determine the appropriate microorganisms to serve as representative surrogate microorganisms.

Protocols developed for efficacy testing shall incorporate, as applicable, recognized, standard procedures. Guidelines for testing and approval of alternate medical waste technologies may be obtained from the Department’s Medical Waste Program.

The Department shall maintain a list of those approved alternate technologies, including manufacturer, product name, model number, or other appropriate identifying information. The list shall be made available by the Department’s Medical Waste Program.

Arizona Medical Waste Regulations

The Arizona Department of Environmental Quality (ADEQ) has amended the state’s Biohazardous Medical Waste (BMW) rules within the Solid Waste (SW) area to improve clarity, bring the standards up to date, address stakeholder concerns, correct references, and citations, and ensure adequate protection of human health and the environment. You can view the amended document here.

BMW is medical waste from regulated generators that is either soaked with blood or that has come into contact with infectious agents capable of transmitting disease to humans.

Arizona’s BMW rules were promulgated in 1999 after more than 6 years of stakeholder feedback and modifications. BMW generators and transporters communicated to ADEQ over the years that updates were necessary to make the process of handling and transporting BMW more clear and protective of human health and the environment. The COVID-19 epidemic further highlighted the need to make these changes. Technical changes were also made to fulfill a commitment to the Governor’s Regulatory Review Council (GRRC). All of these changes increase the health and safety of the community without imposing undue burdens on the regulated community.

What is Arizona Biohazardous Medical Waste?

Biohazardous medical waste is medical waste that is composed of one or more of the following:

Arizona Biohazardous Medical Waste Facilities

To operate a biohazardous medical waste storage, transfer, treatment and disposal facility, an owner or operator must apply for Solid Waste Facility Plan approval.

Arizona Biohazardous Medical Waste Transporters

Biohazardous medical waste transporters must be approved by ADEQ through a registration process. Renewal of registered transporters is required every 5 years.  Rules effective July 01, 2012, require transporters of biohazardous medical waste to pay a registration fee (upon initial and renewal registration) and an annual fee.

Arizona Alternative Medical Waste Treatment Methods

Alternative medical waste treatment methods must be approved and registered with ADEQ for use in Arizona.

Do I Generate Biohazardous Medical Waste in Arizona?

Various businesses throughout the state of Arizona generate biohazardous medical waste and may not be aware that they must follow state laws regarding the proper storage, transfer, treatment, and disposal of biohazardous medical waste. Examples of businesses that generate biohazardous medical waste include (but are not limited to) the following:

As a generator you are ultimately responsible for your waste from generation to treatment, therefore it is vital that you understand state rules, codes, and regulations for biohazardous medical waste to ensure your business is in compliance. A major component in helping to protect yourself as a generator is to choose a reputable biohazardous medical waste transporter that is registered with ADEQ. This registration means that their Transportation Management Plan (including waste transport procedures, personnel training, and business registration) has been reviewed and approved by ADEQ.

You also have rights as a generator to receive documentation from your waste transporter that demonstrates that your waste has been properly treated or disposed of at an approved facility. The Solid Waste Unit encourages you to contact us with any questions you may have regarding your rights and responsibilities as a biohazardous medical waste generator.

Arizona Tattoo Industry Biohazardous Waste Disposal

In August 2005, Arizona adopted laws that require tattoo establishments to handle certain items in the same manner as biohazardous medical waste. Tattoo shops do not require registration with ADEQ, but they must ensure compliance with state laws for generators of biohazardous medical waste. The Solid Waste Unit provides compliance assistance to tattoo shops across the state.

Compliance Assistance

Common biohazardous medical waste transporter, storage, and treatment violations and how to prevent them.

  1. Improper disposal

Biohazardous medical waste needs to be transported by an approved biohazardous medical waste transporter to an approved disposal facility. Do not unload, reload, or transfer biohazardous medical waste to another vehicle in any location other than an ADEQ-approved facility, except in emergencies.

Any person who accepts biohazardous medical waste must keep a signed tracking form for a minimum of one year after the acceptance of the waste. The tracking form must be signed by a transporter and comply with state requirements,2 which include:

Name and address of the generator, transporter, and medical waste treatment, storage, transfer, or disposal facility, as applicable.

Quantity of biohazardous medical waste collected by weight, volume, or number of containers.

Identification number attached to bags or containers.

Date the biohazardous medical waste is collected.

Any person who transports biohazardous medical waste must deliver the waste to an approved biohazardous medical waste storage, transfer, treatment, or disposal facility within 24 hours of collection or refrigerate the waste for no more than 90 days at 40°F (or less) until delivery.

California Medical Waste Regulations

California Medical Waste Generators

The Medical Waste Management Act (PDF) (MWMA), Section 117705 of the California Health and Safety Code, considers any person whose act or process produces medical waste to be a “medical waste generator” in California (e.g., a facility or business that generates, and/or stores medical waste onsite).

Medical waste generators may be either large quantity generators (LQG = 200 or more lbs/month), or small quantity generators (SQG = <200 lbs/month).  Medical waste generators shall register with their local enforcement agency.

California Medical Waste Transfer Stations and Offsite Treatment Facilities

CDPH’s Medical Waste Management Program (MWMP) ensures the proper handling and disposal of medical waste by permitting and inspecting medical waste treatment facilities and transfer stations (PDF) throughout the state.

For the purpose of medical waste management:

In order to store, transfer and/or treat medical waste offsite in California, complete the relevant areas of the application form for an offsite medical waste facility permit as required by the Medical Waste Management Act (MWMA) and Title 22 of the California Code of Regulations (22 CCR).

California Medical Waste Transporters

California adopted statutes into the CA Health and Safety Code (HSC) affecting medical waste transporters in October 1993.   Only medical waste transporters listed with CDPH are allowed to transport medical waste.  See CDPH’s list of current medical waste transporters (PDF).

All medical waste transporters must carry paperwork issued by CDPH in each vehicle while transporting medical waste. To ensure you submit the necessary information please review CDPH 8660 – Medical Waste Transporter Checklist (PDF).

Registration

HSC Section 118025 requires that all medical waste shall be hauled by a registered hazardous waste hauler.

A current hazardous waste transporter I.D. is required to transport medical waste in California. If your company does not currently have such a registration, contact the Department of Toxic Substances Control (DTSC) at (800) 618-6942 or submit your inquiries to transporter@dtsc.ca.gov.

Once your company has a DTSC registration, please attach it to Form CDPH 8668 along with the other requested documents. The DTSC registration and Form CDPH 8668 need to be renewed on an annual basis.

HSC Section 118000(a) mandates that medical waste shall only be transported to a permitted medical waste transfer station or permitted medical waste treatment facility. A list of permitted facilities can be found on the medical waste transfer station and treatment facility page.

Information Requirements

HSC Section 118029 requires all medical waste transporters doing business in California to report information regarding business ownership, location, vehicles, and clients to CDPH’s Medical Waste Management Program (MWMP).

CDPH is required to collect specific information on all medical waste generators serviced by each transporter. Quarterly reports on generators are required within 10 days of the close of the calendar quarters ending March 31, June 30, September 30, and December 31. This information must be supplied by the transporter in an electronic format (computer-generated) as specified in the Data Submission Protocol. 

Colorado Medical Waste Regulations

Medical waste includes wastes generated in a health care setting in the diagnosis, treatment, immunization, or care of humans or animals; generated in autopsy or necropsy; generated during preparation of a body for cremation or interment; generated in research pertaining to the production or testing of microbiologicals; generated in research using human or animal pathogens; or related to accident, suicide, or other physical trauma. “Health care setting” is used in a broad context and does not necessarily mean that these wastes are generated in a medical facility or clinic. Wastes presumed to be medical waste include certain radioactive wastes, blood and body fluids, potentially infectious waste, pathological waste, non-RCRA Subtitle C (hazardous waste) waste pharmaceuticals and vaccines, sharps, trauma scene waste, and any additional waste determined to pose a sufficient risk of infectiousness as established by the Colorado Department of Public Health and Environment (the Department) on a case-by-case basis. It also includes any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill or release of medical waste. Medical waste does not include wastes generated from routine facility maintenance or cleaning activities not involving a spill or release of medical waste or medical waste generated in the home.

What is a Medical Waste Generator?

A medical waste generator is a person whose act or process produces medical waste. When used in this context, “person” includes an individual, partnership, private or municipal corporation, firm, board of metropolitan district or other sanitation district, or other association of persons. Medical waste generators include hospitals, clinics (such as medical, dental, and veterinary), surgery centers, dialysis centers, blood banks, long term care facilities, hospices, funeral homes, laboratories (such as clinical, diagnostic, pathological, veterinary, and biomedical research), pharmacies, body art establishments1 , acupuncture facilities, trauma scene cleanup sites, facilities holding shot clinics or health fairs, and pet shops. Although the majority of medical waste is generated at health care facilities, wastes meeting one or more of the medical waste category descriptions can be generated at other types of facilities. “Facility” is used in a broad context and does not necessarily mean that these wastes are generated in a hospital or clinic.

As a medical waste generator you are responsible for the proper management and disposal of medical waste that is generated at your facility. You must identify the types and categories of medical waste, where in your facility medical waste is generated, properly contain, label, store, and package medical waste, and ensure that medical waste is properly treated and disposed. You must also determine if the waste is subject to other regulatory requirements. This information must be included in your on-site medical waste management plan.

Exemption Household medical waste is exempt from the requirements outlined in this guidance. Due to the potential risks associated with handling household medical waste, separate guidance has been developed to establish best management practices. Information regarding household medical waste management is available on the Hazardous Materials and Waste Management Division’s web site.

Segregation, Containment, Labeling, and Storage

Segregation

Identification and segregation of medical waste from other wastes at the point of generation ensures that only those wastes that need special treatment, handling, and disposal receive it. Waste that is properly segregated at the point of generation can reduce worker exposure and may result in a cost savings for your facility as less waste is treated or disposed of as medical waste. Due to workplace safety considerations, once ordinary solid waste and medical waste have been mixed they cannot be separated. Additional information regarding medical waste identification is available in the “Medical Waste Identification Compliance Bulletin” available from the Department’s website.

In general, medical wastes should be segregated by the type of treatment and disposal appropriate for the waste. If wastes destined for different types of treatment are placed in similar types of bags or containers (e.g., color coded bags or containers), you should have a system in place to identify the planned type of treatment and what is allowable in each bag or container. Bags and containers used to contain medical waste must meet applicable United States Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standards, 29 CFR 1910.1030 and/or United States Department of Transportation (US DOT) Division 6.2 Infectious Substances (49 CFR Parts 171-180) containment and labeling requirements.

A variety of methods can be used to ensure medical waste is properly segregated. Your staff should be provided with hands on training on how to segregate medical waste that is generated at your facility and examples of the types of waste that should not be included in the medical waste stream (e.g., hazardous waste, ordinary solid waste such as office waste, food waste, wrappers and containers, and personal protective equipment that are not contaminated with a transmissible infectious agent potentially capable of causing disease or injury). Strategically placing medical waste receptacles in only those areas of your facility where a specific medical waste stream is generated can assist in reducing the amount of ordinary solid waste being placed in medical waste receptacles. Also, the use of posters and signage indicating what waste is appropriate or inappropriate to place in a medical waste receptacle will help staff with the correct placement of medical waste.

Containment and Labeling of Medical Waste Not Regulated Under OSHA’s Bloodborne Pathogens Standard – Trace Chemotherapy Waste and Non-Hazardous Waste Pharmaceuticals

Trace chemotherapy waste and non-hazardous waste pharmaceuticals should be stored in bags and containers that have sufficient strength to contain the waste and prevent leakage. The bag or container should be labeled with information regarding the contents (e.g. “Trace Chemotherapy Waste” or “Nonhazardous Pharmaceutical Waste”). Bags or containers holding medical waste requiring incineration (e.g. trace chemotherapy waste) should also be labeled with this information (e.g., “Incineration Only” or “Incineration Waste”). To prevent the release of contents, the bag or container should be closed when full or after it is done accepting waste. Non-hazardous waste pharmaceutical containers should have some type of locking mechanism or be stored in a secured area to prevent unauthorized access.

Other federal requirements may apply to trace chemotherapy waste and non-hazardous waste pharmaceuticals, such as:

Containment and Labeling of Medical Waste Regulated Under OSHA’s Bloodborne Pathogens Standard – Blood and Body Fluids, Potentially Infectious Waste, Pathological Waste, and Sharps

Containment

Medical waste that is regulated under OSHA’s Bloodborne Pathogen Standard must be appropriately contained and properly labeled in accordance with 29 CFR 1910.1030. These wastes must be stored in bags or containers that are designed to store the type of medical waste put into it. Bags used to contain medical waste generated at your facility must prevent leakage and have sufficient strength to prevent ripping, tearing, or bursting under normal conditions of use and handling. Bags must be tied off or taped closed when full or done accepting medical waste. During waste generation and storage, bags should be provided with secondary containment to prevent tipping or release of bag contents. Secondary containment is required if the outside of the storage bag is contaminated or if the waste material in the storage bag could puncture the bag. Secondary containment should consist of a disposable or reusable rigid or semi-rigid container that prevents leakage and can be closed after waste has been added to the bag. Reusable secondary containment containers should be cleaned and disinfected after each use. Glass containers should not be used as medical waste storage containers.

Sharps waste must be accumulated, stored, and disposed of in a container that is rigid, leakproof, puncture resistant and closable, consistent with the requirements under OSHA’s Bloodborne Pathogens Standard. It is recommended that sharps containers manufactured for the sole purpose of sharps containment be used. Sharps containers must to be located in areas where sharps waste is generated. To prevent needlestick injuries, containers must never be completely filled or filled past the full line indicated on the sharps container (usually two-thirds to three-fourths full). Sharps containers must be taped closed or tightly lidded when they are no longer in use and ready for disposal.

Radioactive medical waste that will decay-in-storage must be contained in a proper container suitable for the medical waste type, labeled with the biohazard label, and meet Colorado Rules and Regulations Pertaining to Radiation Control 6 CCR 1007-1 Part 4 requirements.

Labeling

Bags and containers of potentially infectious waste, blood and body fluids, pathological waste, and sharps waste must be labeled in accordance with OSHA’s Bloodborne Pathogens Standard. The label must contain the word “Biohazard” and the universal biohazard symbol and the label should be legible and in good condition. The background of the label must be fluorescent orange or orange-red and the universal biohazard symbol and “Biohazard” lettering must be of a contrasting color. Secondary containment containers must also be properly labeled. Although OSHA allows the use of red bags or containers to be used as a substitute for the use of a biohazard label, the Department strongly suggests labeling this type of bag or container with the word “Biohazard” or with the contents of the bag or container (e.g., “Sharps Waste”) and the universal biohazard symbol.

On-Site Storage of Medical Waste

Medical waste generators are allowed to temporarily accumulate and store their own medical waste for on-site treatment or shipment off-site to a commercial medical waste treatment or disposal facility without obtaining a Certificate of Designation (permit) from the local governing body having jurisdiction if they meet certain time and container requirements.

Storage Area

All medical waste must be maintained and stored in a way that will not produce nuisance conditions. An area in your facility should be designated for the storage of medical waste while it is waiting for on-site or off-site treatment and disposal. Medical waste should not be stored in the area where generated once the bag or container is full or is removed from service for any reason. The storage period begins when the bag, container, or sharps container is full, has been tied off, closed or sealed, and/or is no longer being used to collect medical waste. The waste should be moved to the designated medical waste storage area or treated on-site generally within 24 hours of being taken out of service.

The designated medical waste storage area can be located inside or outside, but the storage area should comply with the following:

Storage Area Time Limits

Putrescible medical waste includes blood and body fluids, pathological waste, and any other type of medical waste that contains organic matter capable of decomposing and attracting insects or rodents or causing nuisance conditions like odors. Putrescible medical waste that is not refrigerated, frozen, or treated on-site may be stored on-site for no more than 30 days as long as the waste is packaged to meet all OSHA and US DOT requirements prior to being placed in storage. If packaged waste is discovered to be leaking, it must immediately be overpacked in a new container that meets OSHA and US DOT requirements. Medical waste that is packaged to meet all OSHA and US DOT requirements and is kept refrigerated (45ºF degrees or less) or frozen may be stored on-site for no more than 90 days. Refrigeration and freezer units may range in size from household-type to commercial walk-in units, depending on the amount of medical waste generated and stored on-site.

On-site storage of non-putrescible medical waste, including sealed sharps containers, sealed nonhazardous waste pharmaceutical containers, and trace chemotherapy waste, may not exceed 90 days. These wastes must be packaged in containers that are taken out of service, are in good condition and secured to prevent unauthorized access.

Medical waste that causes nuisance conditions should be immediately refrigerated, frozen or treated on-site, or transported off-site for treatment and disposal. For transport off-site, “immediately” is interpreted to be within 48 hours. You should address alternative waste handling provisions for medical wastes causing nuisance conditions in your medical waste management plan.

Your facility should use some type of tracking mechanism to keep track of the type and amount of medical waste generated and stored. This could include retaining medical waste manifests or shipping papers, maintaining a tracking log, or placing a tag or sticker directly on each medical waste bag or container with the date the medical waste bag or container was tied off, closed, or sealed and removed from service.

Treatment and Disposal

Packaging Medical Waste, Including Trace Chemotherapy and Non-hazardous Waste Pharmaceuticals, for Off-site Transport

Medical waste that will be transported off-site for treatment and disposal must meet United States Department of Transportation (US DOT) requirements (49 CFR Parts 171-180) applicable to the waste type. Medical waste generators who prepare and offer medical waste for shipment must comply with US DOT packaging, marking, labeling, placarding, shipping paper, security plan, and training requirements. Non-hazardous waste pharmaceuticals that are US DEA controlled substances must also meet US DEA requirements (21 CFR Parts 1300 – 1399).

Generators of medical waste that utilize medical waste mail-back services must ensure that the medical waste is packaged according to United States Postal Service (USPS) requirements. Since the mailback service must be specifically authorized by the USPS to mail medical waste and sharps medical waste, they should provide the appropriate receptacles, packaging, labeling and marking materials, and documentation to mail the package. You must ensure that you follow all of the directions provided by the mail-back service provider. Additional information regarding transport of medical waste is available in the Medical Waste Transporters Compliance Bulletin, available on the Hazardous Materials and Waste Management Division’s web site.

On-Site Treatment and Disposal of Infectious Waste

You can elect to treat your infectious medical wastes yourself to render the waste noninfectious without having to obtain a Certificate of Designation, or send the waste offsite to an approved commercial medical waste treatment facility. The Department does not pre-approve or recommend treatment methods, but instead leaves it up to you to determine what is the most appropriate and effective treatment method for your medical waste.

If treating your waste on-site, you are responsible for demonstrating the treatment technology’s effectiveness through testing and use of biological indicators and/or parametric monitoring to confirm that the medical waste has been treated appropriately. Infectious wastes must be treated to achieve a level of at least a 6 Log10 reduction (i.e., a 99.9999% reduction) in the concentration of the biological indicator Mycobacterium phlei or Mycobacterium bovis AND a 4 Log10 reduction (i.e., a 99.99% reduction) in the level of biological indicator Bacillus stearothermophilus, Bacillus subtilis or Bacillus atrophaeus endospores. Some treatment technologies may combine different methods or may include grinding or shredding of the waste to improve treatment efficiency, but in all cases the treated waste must be rendered non-infectious.

Generators conducting on-site treatment of their infectious waste must have written standard operating procedures for implementation of the method, written verification testing procedures including the use of biological indicators and/or parametric monitoring to confirm that an acceptable level of biological inactivation is achieved, an operator training plan, an emergency response plan, a contingency plan for spills or loss of containment, and provisions for alternative waste handling and treatment in the event of equipment breakdown. This information must be included in your medical waste management plan. You must also maintain written operating records including the type and quantity of waste treated and maintenance records appropriate for the type of technology used.

The most common on-site medical waste treatment method is steam disinfection (autoclave). Although rare, generators can incinerate their medical waste provided the facility has the proper permits (e.g., solid waste, air pollution). Other medical waste treatment methods include chemical disinfection, thermal inactivation, irradiation, and gas/vapor sterilization. These treatment techniques may require licensing or permitting from other regulatory programs including, but not limited to, the Colorado Department of Public Health and Environment Hazardous Materials and Waste Management Division Radiation Control Program, Air Pollution Control Division, Water Quality Control Division, and local governmental agencies. Encapsulation, solidification, and/or compaction of medical waste, including sharps waste, without rendering the waste non-infectious are not adequate forms of treatment for infectious wastes.

Medical waste that has been treated to achieve an acceptable level of biological inactivation is considered to have been rendered non-infectious and may be discharged into the sanitary sewer system or disposed of with other non-infectious solid wastes, as appropriate. Sewer disposal may require that you obtain approval from your wastewater treatment facility or the pretreatment authority in charge of your wastewater discharge prior to disposing of fluids or waste to the sewer. Pretreatment (e.g., disinfection or sterilization) may also be required. If you are on an individual sewage disposal system (septic tank), you should not dispose of waste in this manner.

Treated medical waste that is sent to a solid waste disposal facility must be clearly identified as treated medical waste, or you must provide written notice to your solid waste transporter and disposal facility that your ordinary solid waste also includes treated medical waste. Your operating and monitoring records can often be used to document to the sewer authority, transporter and/or disposal facility that your medical waste has been successfully rendered non-infectious.

Untreated medical waste from non-household sources may not be disposed of in a solid waste disposal facility unless the disposal facility has an approved Engineering Design and Operations plan that specifically allows these wastes. Contact the Department at comments.hmwmd@state.co.us if you have questions regarding approved disposal facilities for untreated medical waste.

Medical waste consisting of recognizable human anatomical remains must be disposed of by interment, cremation, incineration or other method consistent with the Mortuary Science Code (Title 12 Article 54 Parts 1 – 4), or by acceptance by a representative of the State Anatomical Board (5 CCR 1006-1).

Treatment and Disposal of Waste Pharmaceuticals and Trace Chemotherapy Waste

Waste pharmaceuticals regulated as controlled substances must be disposed of per DEA regulations (21 CFR 1307.21) or may be sent to a reverse distributor as long as the reverse distributor is a DEA registrant (21 CFR 1307.11). The Department considers hazardous waste pharmaceuticals that are returned to a reverse distributor to be a waste and not a commodity. Therefore, pharmaceuticals that meet the definition of hazardous waste must be managed as a hazardous waste and generally cannot be returned to a reverse distributor. In cases where a waste pharmaceutical meets the definition of a hazardous waste and is also regulated as a controlled substance by the DEA, the Department does allow the pharmaceutical to be sent to a DEA-registered reverse distributor.

The local DEA Special Agent in Charge may instruct you to destroy controlled substances on-site, witnessed by two health care professionals. In the past, this often meant disposal down the drain. The U.S. EPA and the Department strongly discourage the practice of sewer disposal for pharmaceuticals. The preferred alternative is to transfer control of the waste pharmaceutical to a DEA registrant that is specifically approved to manage these wastes. The Special Agent in Charge may also authorize landfill disposal for non-hazardous waste pharmaceuticals following specified protocols.

Waste pharmaceuticals that are not regulated as controlled substances or hazardous wastes are regulated as solid wastes. These wastes may be sent to a reverse distributor or sent to a pharmaceutical mail-back service for proper disposal, treated to encapsulate or solidify the waste at an approved medical waste treatment facility prior to disposal, incinerated at an approved solid or hazardous waste incinerator, or must be disposed of in an approved solid waste disposal site that has an approved Engineering Design and Operations Plan that specifically allows these wastes.

Trace chemotherapy waste must be disposed of in an approved solid waste disposal site that has an approved Engineering Design and Operations Plant that specifically allows this waste, or may be incinerated at an approved solid or hazardous waste incinerator.

Contact the Department at comments.hmwmd@state.co.us if you have questions regarding approved disposal facilities for untreated medical waste. Biological inactivation technologies (e.g., autoclaving) are ineffective in treating waste pharmaceuticals and trace chemotherapy wastes.

Treatment and Disposal of Radioactive Medical Waste

If you use radionuclides for medical purposes, you are required to obtain a radioactive materials license issued by the Department under the Rules and Regulations Pertaining to Radiation Control (6 CCR 1007-1). As a radioactive materials licensee, you may be able to hold the radioactive medical waste for decay-in-storage under the provisions of 6 CCR 1007-1 Section 7.29 until the radioactivity cannot be distinguished from background levels as described in the regulations. If these requirements are met, you may then manage the waste as medical waste without regard for its radioactivity. Wastes contaminated with radioactive material should not be put into a standard medical waste container unless or until the radioactivity has decayed to background levels. If decay-in-storage is not an option, the waste must be managed as radioactive waste.

On-site Medical Waste Management Plan

Each medical waste generator is required to develop and implement an on-site medical waste management plan for each facility. The medical waste management plan must be specific to the type of medical waste generated by your facility and contain the following:

If you have already prepared a Bloodborne Pathogens – Exposure Control Plan and/or developed a Hazard Communication Program in accordance with OSHA requirements, amendments to that plan or program to also contain the above elements may fulfill the medical waste plan requirements.

Designation of Medical Waste

Proper management of medical waste first begins with the identification of the types of medical waste that are generated at your facility. As a waste generator you are responsible for determining if your waste is regulated as medical waste, hazardous waste, radioactive waste, or ordinary solid waste; and if it is subject to other federal, state, and local statutes, regulations, and policies. You must determine the categories of medical waste generated and where each category of medical waste is generated in your facility. This information must be included in the plan. Categories of medical waste that must be considered include radioactive medical waste, blood and body fluids, potentially infectious waste, pathological waste, pharmaceutical waste, sharps, trauma scene waste, and any additional waste determined to pose a sufficient risk of infectiousness as established by the Department on a case-by case basis. These categories are discussed in detail in the “Medical Waste Identification Compliance Bulletin.”

Medical Waste Handling, Treatment, and Disposal Provisions

This section of the plan must describe how each medical waste category is handled in your facility and how it will be treated and disposed. Information regarding how medical waste is segregated, contained, packaged, labeled, transported, stored, and treated (on or off-site) for disposal needs to be included. Provisions for alternative waste handling or disposal during periods when your facility is not in operation, in the event of equipment breakdowns, and in cases where the generator’s medical waste cannot be treated on-site or sent off-site for treatment and disposal must also be considered and addressed. If medical waste is not treated on-site for disposal, then the plan must indicate the medical waste treatment facility and medical waste transporter (if not self-transporting) that will be used. Discharge of blood and body fluids or semi-solid pathological waste into a sanitary sewer system or alternate waste disposal methods, such as using a commercial sharps, medical waste, and/or waste pharmaceutical mail-back program, would also need to be addressed in the plan.

Contingency Planning

You must have a plan to respond to a medical waste spill or loss of containment in order to minimize hazards to human health and the environment. The plan should address:

Employees with job responsibilities involving any aspect of medical waste generation or management should be familiar with this plan and trained in medical waste spill or release response. Staff training and familiarity with the plan will result in a more timely execution of the contingency plan that can minimize the impact of the spill or release.

Staff Training

Medical waste training is necessary to educate employees about the proper management of medical waste generated at your facility. Your medical waste management plan must address what medical waste training will be provided to employees. The type and amount of training will depend on the employee’s job roles and responsibilities. In general, any employee that generates medical waste, places medical waste in containers or bags, works in an area where medical waste is generated or stored, prepares medical waste for off-site transport, self-transports medical waste, treats medical waste on-site, and/or is involved with medical waste recordkeeping should receive training. This training plan may also include or reference federal requirements, such as OSHA and US DOT requirements. Examples of topics that should be included in your medical waste training program include:

Medical waste training should be given to employees at a frequency that ensures that staff are consistently demonstrating proper management and handling of medical waste. Training should be given whenever an employee starts a new position with job responsibilities involving some aspect of medical waste generation or management, when a new medical waste stream is generated at the facility, or when a new medical waste procedure is implemented at the facility. It is recommended that all facility personnel with job duties related to medical waste management receive annual refresher training and additional training when a new medical waste procedure is implemented.

Designation of a Person Responsible for Plan Implementation

At least one employee at your facility must be designated with the responsibility of implementing the medical waste management plan. Alternate employees should also be selected in case the designated individual is unavailable (e.g., due to vacation, illness, etc.). The designated individual and alternate(s) should have a strong knowledge of the plan and be able to communicate to other employees the importance of this plan, which employees are affected by the plan, and what is expected from staff to implement plan components.

Recordkeeping

A copy of your facility’s medical waste management plan must be maintained at your facility. The plan should be reviewed annually and updated whenever changes related to medical waste generation or handling occur. Unless requested by the Department, a copy of this plan does not have to be submitted to the Department. However, this plan must be available upon request to the medical waste transporter, medical waste treatment facility, and to the Department. It is recommended that you keep records to show how certain aspects of the plan are being implemented. Any records related to medical waste (e.g., medical waste accumulation logs, shipping papers or manifests, on-site treatment logs, training rosters) should be kept for at least three years.

Connecticut Medical Waste Regulations

Connecticut Requirements for Generators of Biomedical Waste.

(1) A biomedical waste generator shall identify the solid waste he generates which is biomedical waste.

(2) A biomedical waste generator shall segregate biomedical waste from other solid waste to the extent practicable prior to placing biomedical waste in primary containers. Biomedical waste shall be segregated into the following categories:

   (A) Sharps and any residual substances therein

   (B) Body fluids in a quantity greater than 20 cubic centimeters

   (C) Other biomedical waste

(3) A biomedical waste generator shall prepare a written biomedical waste management plan for each facility at which he generates biomedical waste. Such plan shall set forth policies and procedures for segregating biomedical waste as required by subdivision (2) of this subsection and for assuring that the following requirements are satisfied:

   (A) Biomedical waste mixed with hazardous waste pursuant to Section 22a-115 of the General Statutes shall be managed as hazardous waste in accordance with law.

   (B) Biomedical waste mixed with radioactive material subject to Section 22a-148 of the General Statutes shall be managed as radioactive material in accordance with law.

   (C) Any solid waste which is neither hazardous pursuant to Section 22a-148 of the General Statutes nor is a radioactive material subject to Section 22a-148 of the General Statutes and which is mixed with biomedical waste shall be managed as biomedical waste in accordance with law.

   (D) Any category of biomedical waste set forth in subdivision (2) of this subsection shall not be mixed with, or placed in a primary container with, any other such category of biomedical waste.

(4) Before transporting or offering for transport biomedical waste, a generator shall package the waste according to the following requirements:

   (A) Biomedical waste shall be placed in containers that are:

       (i) Rigid.

       (ii) Leak-resistant.

       (iii) Impervious to moisture.

       (iv) Sufficiently strong to prevent tearing or bursting under normal conditions of use and handling.

       (v) Sealed to prevent leakage.

   (B) Sharps and any residual substances therein shall be placed in containers that are puncture-resistant and meet the requirements of subparagraph (A) of this subdivision.

   (C) Body fluids in quantities greater than 20 cubic centimeters shall be placed in containers that are break-resistant and tightly lidded or stoppered and meet the requirements of subparagraph (A) of this subdivision.

   (D) A generator may use as many containers as necessary to satisfy the requirements of subparagraphs (A), (B) and (C) of this subdivision.

   (E) An individual item of biomedical waste that is too large to be placed in a standard sized container shall be deemed an “oversized item” and shall be handled in a manner that minimizes contact with transport workers and the public. A water-resistant identification tag identifying in indelible writing the generator’s name, address, and phone number shall be enclosed with or affixed to an oversized item. A generator shall indicate any special handling instructions for an oversized item in Box 14 of the tracking form.

   (F) A container for biomedical waste shall not be reused to contain biomedical waste or for any other purpose unless

      (i) the surfaces of such container were protected from contamination by infectious agents through the use of a liner, bag or other device which was removed with the waste

      (ii) such container has been thoroughly washed to remove any visible indication of contamination and then disinfected by one of the procedures specified in subdivision (e) (6) of this section.

(5) Persons packaging biomedical waste shall wear such personal protective equipment as is required by law.

(6) Biomedical waste that is intended to be stored, treated, or disposed of at the site where it is generated shall be segregated and packaged in primary containers in accordance with the requirements of this subsection.

(7) Before transporting or offering for transport biomedical waste, a generator shall affix to, or cause to be imprinted on, the outside of each container a water-resistant label displaying in indelible writing the universal biohazard     symbol or the words “medical waste” or “infectious waste.” Such a label need not be affixed to or imprinted on a container of biomedical waste which has been decontaminated but not treated, but such a container shall be marked in     accordance with subdivision (8) of this subsection.

(8) Before transporting or offering for transport biomedical waste, a generator shall mark containers as follows:

   (A) A water-resistant identification tag of at least three inches by five inches shall be affixed to the outside of both the primary and secondary containers and shall indicate in indelible writing the generator’s name and address. In addition, the tag affixed to the secondary container shall indicate in indelible writing the name, address, business location and permit number of the transporter who accepted the waste from the generator and the date on which such transporter accepted the waste.

   (B) When biomedical waste is transported by more than one transporter, each transporter other than the transporter who accepted the waste from the generator shall affix a water-resistant identification tag on the outside of the secondary container. Such tag shall be at least three inches by five inches and shall be affixed in such manner as not to obscure previously affixed identification tags. Such tag shall indicate in indelible writing the name, address, business location, and permit number of the transporter affixing the tag and the date such transporter accepted the waste.

(9) No person shall hire or use a transporter for the transportation of biomedical waste unless such transporter has been issued a permit by the Commissioner under subsection (g) of this section.

Connecticut Requirements for Storage of Biomedical Waste.

(1) Biomedical waste shall be stored such that other materials may not become mixed with such waste and shall be stored in areas which are accessible only to those persons who are authorized by the generator, transporter, or solid waste facility operator, as applicable, to handle biomedical waste. Any outdoor storage area, such as a dumpster, shed or trailer, shall be locked.

(2) Biomedical waste shall be stored in a manner and location that maintains the integrity of its packaging and provides protection from water, precipitation, and wind.

(3) All areas used for the storage of biomedical waste shall be constructed of finished materials that are impermeable and capable of being easily maintained in a sanitary condition.

(4) Biomedical waste shall be stored only in a nonputrescent state; to maintain a nonputrescent state, biomedical waste may be refrigerated during storage.

(5) A sign displaying the universal biohazard symbol shall be posted wherever biomedical waste is stored.

(6) Biomedical waste shall not be compacted or subjected to violent mechanical stress during storage.

(7) Biomedical waste shall be stored in a manner that provides protection from animals and does not provide a breeding place or food source for insects or rodents.

Connecticut Requirements for Transfer of Biomedical Waste.

(1) Biomedical waste shall be handled during transfer in a manner that does not impair the integrity of its packaging.

(2) Trash chutes shall not be used to transfer biomedical waste.

(3) Biomedical waste shall not be compacted or subjected to violent mechanical stress during transfer.

Requirements for Transportation of Biomedical Waste.

(1) A biomedical waste transporter shall not transport or accept for transport biomedical waste that is not packaged, labeled and marked in accordance with subdivisions (4), (7), and (8) of subsection (b) of this section.

(2) A biomedical waste transporter shall not transport or accept for transport biomedical waste which is not accompanied by a tracking form which complies with subsection (h) of this section.

(3) A biomedical waste transporter shall ensure that any vehicle used to transport biomedical waste meets the following requirements:

    (A) Biomedical waste shall be transported in a fully enclosed, leak-resistant cargo compartment.

    (B) Biomedical waste shall not be subjected to compaction or violent mechanical stress during loading and unloading.

    (C) Each cargo compartment shall be constructed of impermeable materials and kept free of visible contamination.

    (D) No cargo compartment shall be used to transport any food or drink intended for human or animal consumption.

    (E) Each cargo compartment shall be locked when left unattended.

(4) Biomedical waste shall be transported only in a nonputrescent state; to maintain a nonputrescent state, biomedical waste may be refrigerated during transport.

(5) A biomedical waste transporter shall ensure that his name, permit number and the words “medical waste” are displayed on the two sides and back of each cargo compartment in letters that are at least three inches tall and in a color contrasting with the color of such compartment.

(6) Vehicle surfaces that have had contact with spilled or leaked biomedical waste shall be decontaminated by

    (A) cleaning with a solution of industrial strength detergent for the purpose of removing visible soil.

    (B) one of the following procedures:

(7) Any person loading or unloading biomedical waste onto or off of a vehicle shall wear such personal protective equipment as is required by law.

(8) Each vehicle shall carry a spill clean-up kit which includes at least the following:

    (A) Enough absorbent material to absorb at least ten gallons of liquid.

    (B) One gallon of hospital-grade disinfectant in a sprayer capable of dispersing its charge both in a mist and in a stream at a distance of ten feet.

    (C) Fifty red plastic bags, seals, and labels. Such bags shall

    (D) Enough clean impermeable overalls, gloves, boots, caps, and surgical masks for use by at least two persons. Overalls, boots, and caps should be fitted to the persons intended to wear them and shall be made of Tyvek (Registered Trademark) or material that provides equivalent protection. Top boot coverings shall be at least 75 mil thick; boot soles shall be at least 3/4 inch thick, and boot heels shall be at least 1-1/4 inches thick. Gloves shall be of heavy neoprene or material that provides equivalent protection and shall be at least 25 mils thick. Duct tape for sealing clothing at the wrists and ankles shall be included in each cleanup kit.

    (E) A fire extinguisher, boundary marking tape, a high-intensity flashlight, and an American National Red Cross standard 24-unit first aid kit or its equivalent.

(9) In the event of a biomedical waste spill, personnel wearing clean-up apparel and using equipment described in subparagraph (8) (D) of this subsection shall immediately:

    (A) Secure the area where the spill took place.

    (B) Apply a sufficient amount of absorbent material in and around the spill area such that all liquid spillage is contained and absorbed.

    (C) Place damaged containers and spilled biomedical waste into bags specified in subparagraph (8) (C) of this subsection.

    (D) Decontaminate the area affected by the spill and take other clean-up measures as appropriate under the circumstances.

    (E) Clean and decontaminate used reusable components of the clean-up kit.

    (F) Clean and decontaminate reusable components of apparel and related equipment before disrobing.

    (G) Remove apparel and related equipment and place disposable items thereof in bags specified in subparagraph (8) (C) of this subsection.

    (H) Replace used non-reusable components of the clean-up kit.

Requirements for Treatment and Disposal of Biomedical Waste.

(1) A solid waste facility shall not accept biomedical waste which is not packaged, labeled, and marked in accordance with subdivisions (4), (7), and (8) of subsection (b) of this section.

(2) A solid waste facility shall not accept biomedical waste which is not accompanied by a tracking form which complies with subsection (h) of this section.

(3) Biomedical waste shall be disposed of as follows:

 (A) Chemotheraphy waste shall be disposed of only by incineration.

 (B) Pathological waste shall be disposed of only by incineration or interment.

 (C) Infectious waste shall be disposed of only by

 (i) incineration.

 (ii) discharge to a sanitary sewer, provided that such waste is in liquid or semi-solid form, that secondary treatment is available at the publicly owned treatment works or privately owned treatment works to which such waste is discharged, that local law does not prohibit such discharge, that all permits and other authorizations required by law have been obtained for such discharge, and that aerosol formation is minimized during such discharge to such sewer; or

 (iii) any other method which provides protection of the public health and the environment at least equivalent to that provided by the disposal methods specified in this subparagraph and which is first described in writing to the Commissioner and approved in writing by the Commissioner.

(4) No person shall:

 (A) Deliver biomedical waste or cause biomedical waste to be delivered to any incinerator, whether located inside or outside of Connecticut, unless such incinerator complies with all applicable law; or

 (B) Operate an incinerator at which biomedical waste is burned unless such incinerator complies with all applicable law, including but not limited to Sections 22a-174-1 through 22a-174-29 of the Regulations of Connecticut State Agencies.

(5) Biomedical waste incinerator residue shall be managed as a special waste in accordance with Section 22a-209-8 (f) of the Regulations of Connecticut State Agencies.

(6) A steam sterilizer used to decontaminate biomedical waste shall be operated in accordance with the following requirements:

 (A) In a gravity flow sterilizer, biomedical waste shall be subjected to a temperature of not less than 250° F (121° C) at 15 pounds per square inch of gauge pressure for no less than 60 minutes.

 (B) In a vacuum type sterilizer, biomedical waste shall be subjected to a temperature of not less than 270° F (132° C) at 27 pounds per square inch gauge pressure for no less than 45 minutes.

 (C) Notwithstanding subparagraphs (A) and (B) of this subdivision, a different combination of operational time, temperature and pressure may be utilized for steam sterilization of biomedical waste if such combination is first described in writing to the Commissioner and approved in writing by the Commissioner. The Commissioner will not grant approval unless such combination is proven on the basis of thorough tests, including tests of its capacity to killBacillus stearothermophilus, to completely and reliably kill all microorganisms in waste at design capacity.

 (D) Biomedical waste shall be steam sterilized in its primary container. The primary container shall be placed in the sterilization chamber so that sufficient space is provided between the chamber walls and the container to allow the steam to penetrate the container. The primary container shall then be unsealed to allow the steam to penetrate the contents of the container.

 (E) Unless a steam sterilizer is equipped to continuously monitor and record temperatures during the entire length of each sterilization cycle, the operator of such sterilizer shall affix to the primary container temperature-sensitive tape which will indicate when the desired temperature is reached. Biomedical waste shall not be considered decontaminated unless the temperature-sensitive tape indicates that a temperature of at least 250° F (121° C) was reached during the sterilization process. A steam sterilizer which is used for the first time after the effective date of this section shall automatically and continuously monitor and record temperatures throughout the entire length of each steam sterilization cycle.

 (F) At least once during every forty hours of operation, tests shall be conducted to evaluate the effectiveness of the sterilization process, including tests of the capacity of such process to killBacillus stearothermophilus. A log shall be maintained recording the dates and results of such tests.

 (G) At least once during every forty hours of operation, a sterilization unit shall be evaluated to determine whether it is operating properly with respect to temperature and pressure. A log shall be maintained recording the dates and results of such evaluations and the dates of calibration.

 (H) For each sterilization unit a log shall be maintained recording, for each use, the date, time, operator, type and approximate amount of biomedical waste treated, the sterilization pressure reading and the post-sterilization reading on the temperature-sensitive tape.

(7) Unless it is physically altered so as to render it unrecognizable as biomedical waste, decontaminated biomedical waste shall be subject to the requirements of this section.

(8) If biomedical waste is treated or disposed of at the site where it was generated, the generator shall develop written procedures for each treatment or disposal method in use at such site and for ensuring compliance with such procedures. Such procedures shall be incorporated into the biomedical waste management plan required by subdivision (b) (3) of this section and shall

 (A) assure the effectiveness of any treatment method in use and reflect acceptable standards of practice;

 (B) provide for and conduct an ongoing program of staff training on the implementation of such procedures and the requirements of this section; and

 (C) provide for a quality assurance/quality control program to assure compliance with the biomedical management plan prepared pursuant to subsection (b) of this section.

Requirements for Biomedical Waste Transporters.

(1) Other than an air carrier, no person shall transport or accept for transport biomedical waste unless such person has been issued a permit by the Commissioner under this subsection to transport biomedical waste.

(2) A small quantity generator may transport his own biomedical waste without a permit issued by the Commissioner under this subsection, provided that:

 (A) Such generator complies with the requirements of subdivisions (1) through (5), (7) and (8) of subsection (b) of this section;

 (B) The biomedical waste is transported to (i) a lawfully operating solid waste facility with which such generator has a written agreement to deliver his biomedical waste, or (ii) another place of business in Connecticut of such generator; and

 (C) The biomedical waste is transported (i) exclusively by such generator or by an employee whom he has authorized in writing to transport such waste; and (ii) in a vehicle owned by such generator or such employee.

 (D) Such generator complies with the requirements of subdivision (i) (4) of this section.

(3) A small quantity generator who causes biomedical waste to be transported by the U.S. Postal Service is exempt from the requirements of this subsection and subsections (h) and (i) of this section, provided that:

 (A) Such biomedical waste consists only of discarded used sharps and discarded unused hypodermic needles, scalpels, suture needs and syringes;

 (B) Each package of such waste is sent registered mail, return receipt requested, indicating the name and address of the person to whom the waste was sent, the date when it was delivered, and the signature of the recipient; and

 (C) Complies with the requirements of subdivision (i) (5) of this section.

(4) An applicant for a permit under this subsection shall file his application with the Department on a form prescribed by the Commissioner. Such application shall include the following:

 (A) The applicant’s name, address, and business location.

 (B) The manufacturer, model, year of manufacture, identification number, and cargocarrying capacity of each vehicle, used or to be used by the applicant, proof of ownership of such vehicle, and proof of current registration for such vehicle with a state motor vehicle department or agency.

 (C) The address of any transfer station or of any vehicle parking area used or to be used by the applicant pursuant to subdivision (15) of this subsection.

 (D) The place or places where, and the manner in which, the applicant delivers or intends to deliver biomedical waste for treatment, storage, or disposal.

 (E) Evidence of security from an insurer or surety authorized to do business in the State of Connecticut. Such security shall be in an amount of not less than $100,000 and shall provide liability coverage for bodily injury and property damage, including liability for environmental restoration resulting from negligence in the operation, maintenance, or use of any motor vehicle for transportation of biomedical waste. Security required under this paragraph:

 (i) Shall remain in effect continuously while the permit is in effect;

 (ii) Provide for written notification of the insurer’s or surety’s intent to cancel at least 35 days before cancellation; and

 (iii) May be replaced by other security provided the liability of the retiring insurer or surety terminates on the effective date of the replacement security or at the end of the 35 day cancellation period required in subparagraph (E) (ii) of this subdivision, whichever is sooner.

 (F) Evidence that biomedical waste transported by the applicant will be delivered to a lawfully permitted solid waste facility.

 (G) Any other information reasonably required by the Commissioner to demonstrate that the applicant can be expected to safely transport biomedical waste and comply with all applicable provisions of this section during the term of the permit.

(5) A permit applicant shall make each vehicle and related equipment, and each vehicle parking area to be used by the applicant pursuant to subdivision (15) of this subsection, available for inspection by the Department in a safe and convenient location and at a reasonable time. The purpose of such inspection shall be to determine whether such vehicle complies with the requirements of subdivisions (3), (5), and (8) of subsection (e) of this section.

(6) The Commissioner shall decide whether to grant or deny a permit application based upon a review of the information and materials submitted by the applicant, the results of the vehicle inspection described in subdivision (4) of this subsection, and any other consideration authorized by law.

(7) The Commissioner shall notify an applicant in writing of the decision on the permit application. If an application is denied, the notice shall specify the reasons for denial. An application may be denied because the applicant has failed either to (A) comply with subdivision (4) or (5) of this subsection or (B) demonstrate that he can be expected to safely transport biomedical waste and comply with all applicable provisions of this section during the term of the permit. If the Commissioner grants an application the Department shall assign a permit number to the permittee.

(8) A biomedical waste transporter shall include his permit number on each tracking form.

(9) (A) A permit shall expire two years after the date of issuance. An application to renew a permit made no later than ninety days before the expiration date of such permit shall be deemed timely and sufficient for purposes of Section 4-182 (b) of the General Statutes.

 (B) The Commissioner may revoke a permit issued under this subsection if the permittee

 (i) fails to comply with a statute, regulation or license administered, or order issued, by the Commissioner;

 (ii) fails to maintain in effect during the permit term the security specified in subparagraph (4) (E) of this subsection; or (iii) cannot be expected to safely transport biomedical waste or comply with all applicable provisions of this section during the term of the permit.

(10) A biomedical waste transporter shall notify the Department in writing of any change in majority ownership, name, address, or business location.

(11) A permit issued under this subsection is not transferable.

(12) Whenever any vehicle owned or operated by a biomedical waste transporter is involved in a spill of biomedical waste or whenever the vehicle is involved in an accident which renders the vehicle in non-compliance with this section, such transporter shall immediately notify both the Department and the director of health of the municipality in which the spill or accident occurred.

(13) Upon request of the Department, a biomedical waste transporter shall:

 (A) Allow the Department to inspect tracking forms, shipment logs, reports, permits, licenses, billing records or other documents related to the transportation or other handling of biomedical waste.

 (B) Allow the Department to inspect any vehicle or related equipment or any vehicle parking area used by the transporter pursuant to subdivision (15) of this subsection.

 (C) Decontaminate, utilizing procedures described in subdivision (6) of subsection (e), or allow the Department to decontaminate at the owner’s expense, any vehicle that has been in contact with biomedical waste, or take or allow the Department to take any other measures necessary to make such vehicle safe for inspection.

(14) A generator who transports his own biomedical waste from its original generation point to a central collection point shall be exempt from the requirements of subsections (e), (g), and (h) of this section, provided that:

 (A) The biomedical waste is transported by the generator or an employee authorized in writing in a vehicle owned by such generator or employee;

 (B) The original generation point and the central collection point or solid waste facility are located in Connecticut; and

 (C) The generator compiles and retains a shipment log as required by subsection (i) (2) of this section.

(15) A biomedical waste transporter may store biomedical waste in the same vehicle he used to pick up and transport such waste from a generator only if:

 (A) Such vehicle is parked at a location that

 (i) Is under the direct control of the transporter, and

 (ii) Has been approved for such use by the Commissioner in the transporter’s biomedical waste transporter permit issued under this subsection;

 (B) The location where such vehicle is parked is secured to prevent access thereto by any person other than the transporter and his employees;

 (C) Such vehicle is parked at such location for no longer than 48 consecutive hours, excluding weekends and State holidays;

 (D) The biomedical waste is stored in accordance with the provisions of subsection (c) of this section;

 (E) Such vehicle complies with the provisions of subdivision (e) (3) of this section; and

 (F) No biomedical waste is loaded on to or off of such vehicle during storage.

 (h) Requirements for Tracking Biomedical Waste.

 (1) Except as provided in this subsection, a generator who transports or offers for transport biomedical waste shall use the tracking form in Appendix I of this section to track the movement of such waste from its site of generation to a solid waste facility or facilities for purposes of storage, treatment or disposal.

 (2) Except as provided in subdivisions (g) (2), (3), and (14) of this subsection, before transporting or offering or delivering for transport biomedical waste, a generator shall prepare at least the number of tracking form copies that will provide himself and each transporter with one copy, and the operator of each solid waste facility where the waste is to be treated, stored or disposed with two copies.

 (3) When preparing the tracking form, a generator shall:

 (A) Follow the instructions included in Appendix I of this section;

 (B) On all copies of the tracking form, sign the certification statement by hand;

 (C) On all copies of the tracking form, have the transporter write his signature and the date he accepts the waste;

 (D) Retain one copy of the signed and dated tracking form.

 (4) Notwithstanding any other provision of this section, when a generator offers or delivers biomedical waste directly to a rail transporter for transport to a non-rail transporter or solid waste facility in Connecticut, such generator shall forward at least three copies of the tracking form, completed in accordance with subdivision (3) of this subsection, to:

(A) Such non-rail transporter, if any; or

(B) The operator of such solid waste facility.

 (5) A generator who offers or delivers biomedical waste to a transporter, other than a rail transporter, for transport to a facility outside Connecticut for treatment, storage, or disposal shall request that the operator of such facility provide written confirmation to such generator that the waste was received. If the generator does not receive such confirmation within 45 days from the date he offered or delivered the waste for transport, he shall submit an exception report as required pursuant to subdivision (i) (11) of this section.

 (6)

 (A) A transporter shall not accept biomedical waste unless it is accompanied by a tracking form completed in accordance with Appendix I of this section.

 (B) Notwithstanding subparagraph (A) of this subdivision, a non-rail transporter may accept from a rail transporter biomedical waste that is not accompanied by a tracking form, provided that such non-rail transporter complies with subdivisions (8) and (13) of this subsection before delivering the waste to the next transporter or solid waste facility.

 (7) Before accepting biomedical waste that is accompanied by a tracking form, a transporter shall:

 (A) Verify that the tracking form accurately reflects the number of containers and the weight in pounds of all (i) untreated and (ii) decontaminated biomedical waste accepted;

 (B) On all copies of the tracking form, provide his handwritten signature and the date he accepted the waste from the generator or prior transporter, as applicable; and

 (C) If the transporter is the first transporter of the waste, return a copy of the signed and dated tracking form to the generator before accepting the waste, or if the transporter is a subsequent transporter of the waste, return a copy of the signed and dated tracking form to the prior transporter before accepting the waste; and

 (D) Retain one copy of the signed and dated tracking form.

 (8) A transporter, other than a rail transporter, shall ensure that the tracking form accompanies the biomedical waste during transport.

 (9) When a transporter, other than a rail transporter, delivers biomedical waste to another transporter or a solid waste facility in Connecticut, the delivering transporter shall:

 (A) On all copies of the tracking form, obtain the date of delivery and the handwritten signature of the accepting transporter or the operator of the solid waste facility;

 (B) Retain one copy of the signed and dated tracking form; and

 (C) Give the remaining copies of the signed and dated tracking form to the accepting transporter or the owner of the facility.

 (10) When a transporter, other than a rail transporter, delivers biomedical waste to a transporter outside Connecticut or facility outside Connecticut, the delivering transporter shall:

 (A) Verify that the waste has been delivered to the accepting transporter or operator of the facility;

(B) On all copies of the tracking form, have the accepting transporter or facility operator write his signature and the date he accepts the waste, or if the accepting transporter or facility operator will not provide his signature, the delivering transporter shall write his own signature and the date he delivers the waste;

(C) Retain one copy of the signed and dated tracking form; and

(D) Return all remaining copies of the signed and dated tracking form by mail to the generator.

(11) A rail transporter shall ensure that a shipping paper accompanies each shipment of biomedical waste during transport and contains all the information required on the tracking form, other than that required by Boxes 7, 10, and 15. A rail transporter who accepts biomedical waste from a prior rail transporter and delivers such waste to a subsequent rail transporter is not required to sign the shipping paper relating to such shipment of waste.

(12) When a rail transporter delivers biomedical waste to a solid waste facility in Connecticut, such transporter shall:

(A) Have the operator of the solid waste facility write his signature and the date he accepts the waste on all copies of the tracking form which was forwarded by the generator or the first non-rail transporter to the solid waste facility, or, if the tracking form has not been received by the solid waste facility, on the shipping paper; and

(B) Retain a copy of the signed and dated tracking form or shipping paper, as applicable.

(13) When a non-rail transporter accepts biomedical waste from a rail transporter, such non-rail transporter shall:

(A) Write his signature and the date he accepts the waste on all copies of the tracking form which was forwarded by the generator or first non-rail transporter to the accepting non-rail transporter, or, if the tracking form has not been received by the accepting non-rail transporter, on the shipping paper;

(B) Leave a copy of the signed and dated shipping paper with the rail transporter, if applicable; and

(C) Retain a copy of the signed and dated shipping paper or tracking form, as applicable.

(14) A transporter who accepts biomedical waste from a small quantity generator who does not voluntarily use the tracking form need not comply with the requirements of subdivision (6) of this subsection, provided that:

(A) Such transporter compiles a log containing the following information for each shipment of biomedical waste he accepts from a small quantity generator:

(i) The generator’s name and address;

(ii) The number of containers and total weight of (1) untreated and (2) decontaminated waste accepted; and

(iii) The date the waste is accepted;

(B) Such transporter carries such log in his vehicle while transporting the waste to the next transporter or solid waste facility, as applicable;

(C) Such transporter signs and dates the generator’s log required under subdivision

(i)

(3) of this subsection; and

(D) Such transporter complies with subdivision (17) of this subsection.

(15) Except as provided in subdivision (14) of this subsection, a transporter shall deliver the entire quantity of biomedical waste that he accepts from a generator or prior transporter to:

(A) The solid waste facility identified on the tracking form, or

(B) The next transporter, if any.

(16) When biomedical waste cannot be delivered in accordance with subdivision (15) of this subsection, a biomedical waste transporter shall:

(A) Contact the generator for further directions;

(B) Revise the tracking form according to the generator’s instructions; and

(C) Deliver the entire quantity of biomedical waste according to the generator’s instructions.

(17) A transporter shall initiate a tracking form, in accordance with the provisions of subdivisions (2) and (3) of this subsection, for all biomedical waste accepted from each small quantity generator who does not voluntarily use the tracking form.

(18)

(A) A transporter may consolidate multiple shipments of biomedical waste on a single tracking form, provided that each such shipment weighs less than 220 pounds and such transporter initiates a new tracking form for such consolidated waste in accordance with the provisions of subdivisions (2) and (3) of this subsection.

(B) When a transporter receives from a solid waste facility a copy of a tracking form which he initiated pursuant to subparagraph (A) of this subdivision, and which the operator of such facility signed and dated in accordance with subdivision (20) of this subsection, such transporter shall:

(i) Attach a copy of the tracking form received from the solid waste facility to the copy of the tracking form originally prepared by the generator;

(ii) Retain a copy of the tracking form received from the solid waste facility; and

(iii) Return a copy of the tracking form received from the solid waste facility, together with a copy of the tracking form originally prepared by the generator, to the generator within 15 days of receiving the tracking form from the solid waste facility.

(19) For each tracking form initiated pursuant to subparagraph (18) (A) of this subsection, a transporter shall compile a consolidation log reflecting all shipments of biomedical waste consolidated on that form. The consolidation log shall accompany the tracking form during transportation of the waste and shall contain the following information for each shipment:

(A) Name and address of generator;

(B) Date on which the shipment was accepted by such transporter;

(C) Number of containers and the weight in pounds of all (i) untreated and (ii) decontaminated biomedical waste in the shipment; and

(D) Name, address and state biomedical waste transporter permit number of each previous transporter, if any.

(20) When a solid waste facility accepts biomedical waste accompanied by a tracking form, the operator of such facility shall:

(A) Indicate in Box 23 of all copies of the tracking form any of the following:

(i) Any variation between the number of containers reportedly shipped by the generator and the number actually received by such solid waste facility;

(ii) Any variation between the number of containers of

(i) untreated and

(ii) decontaminated biomedical waste reportedly shipped by the generator and the number actually received by the solid waste facility;

(iii) Any containers that are broken, torn, or leaking; and

(iv) Lack of any required information or signatures on the tracking form;

(B) On all copies of the tracking form, write the delivery date of the waste and his handwritten signature, such signature constituting certification that the waste reflected on the tracking form was actually accepted by such solid waste facility;

(C) Before the transporter leaves the facility, give him at least one copy of the signed and dated tracking form;

(D) Within 15 days of accepting the waste, send a copy of the signed and dated tracking form to the generator or transporter who initiated the tracking form; and

(E) Retain a copy of the signed and dated tracking form.

(21)

(A) When a solid waste facility accepts biomedical waste from a rail transporter before receiving the tracking form forwarded by the generator or first non-rail transporter, the operator of the solid waste facility shall:

(i) Provide on the rail transporter’s shipping paper the information described in subparagraphs (20) (A) and (B) of this subsection;

(ii) Before accepting the waste, give the rail transporter at least one copy of the signed and dated shipping paper;

(iii) Within 15 days of accepting the waste, send a copy of the signed and dated shipping papers to the generator or first non-rail transporter who initiated the shipping paper; and (iv) Retain a copy of the signed and dated shipping paper.

(B) Upon receiving a tracking form forwarded by a generator or first non-rail transporter, the operator of a solid waste facility shall:

(i) provide on the tracking form the information described in subparagraphs (20) (A) and (B) of this subsection,

(ii) within 15 days of receiving such tracking form send a copy of the signed and dated tracking form to the generator or first non-rail transporter who initiated the tracking form, and

(iii) retain a copy thereof.

(22) When the operator of a solid waste facility accepts biomedical waste and (i) discovers any condition described in subparagraph (20) (A) of this subsection or (ii) the waste is unaccompanied by a tracking form, such operator shall attempt to resolve the problem with the generator or transporter. If such operator is unable to resolve the problem, he shall submit a letter, within 15 days of accepting the waste, to the Department describing the nature of the problem and his attempts to resolve it. The letter shall be accompanied by a legible copy of the tracking form or shipping paper in question when the problem is of the type specified in subparagraph (20) (A) of this subsection. If the problem is of the type specified in subparagraph (20) (A) (iv) of this subsection, the operator shall specify in his letter the number of containers and the weight in pounds of all (A) untreated and (B) decontaminated biomedical waste accepted, and the name and address of each generator and transporter of the waste.

(i) Recordkeeping and Reporting Requirements for Generators, Transporters, and Solid Waste Facilities.

(1) Except as provided in subdivisions (3), (4) and (5) of this subsection a generator shall retain a copy of each tracking form signed in accordance with subparagraphs (h) (3) (B) and (C) of this section for at least three years from the date he offers or delivers biomedical waste to a transporter.

(2) A generator who seeks under subdivision (g) (14) of this section to be exempt from the requirements of subsections (e), (g), and (h) of this section shall comply with the following requirements:

(A) At the original generation point such generator shall compile a shipment log which includes an entry for each shipment of biomedical waste, and shall retain each such entry for at least three years from the date the waste is transported.

(B) Each entry in the shipment log required in subparagraph (A) of this subdivision shall consist of the following:

(i) The date the biomedical waste is transported from the original generation point;

(ii) The weight of (i) untreated and (ii) decontaminated biomedical waste transported;

(iii) The address or location of the central collection point or solid waste facility, as applicable; and

(iv) The signature of the individual who transports the waste.

(C) At the central collection point such generator shall compile a shipment log which includes an entry for each shipment of biomedical waste, and shall retain each such entry for at least three years from the date the waste is received at the central collection point from the original generation point.

(D) Each entry in the shipment log required in subparagraph (C) of this subdivision shall consist of the following:

(i) The date the biomedical waste is received at the central collection point;

(ii) The weight of (1) untreated and (2) decontaminated biomedical waste received;

(iii) The address or location of original generation point; and

(iv) The signature of the individual who manages the central collection point.

(3) A small quantity generator who uses the services of a transporter to transport biomedical waste and who does not voluntarily prepare the tracking form is subject to the following recordkeeping requirements:

(A) Such small quantity generator shall compile a log which includes an entry for each shipment of biomedical waste, and shall maintain each such entry for three years from the date the waste is accepted by the transporter.

(B) Each entry in the log required in subparagraph (A) of this subdivision shall consist of:

(i) The transporter’s name and address;

(ii) The transporter’s state biomedical waste transporter permit number;

(iii) The weight of (1) untreated and (2) decontaminated biomedical waste transported;

(iv) The date the waste is delivered to the transporter; and

(v) The signature of the transporter or his employee, as applicable, who accepts the waste.

(4) A small quantity generator who transports biomedical waste pursuant to subdivision (g) (2) of this section shall comply with the following requirements:

(A) Such small quantity generator shall compile a log which includes an entry for each such shipment of biomedical waste, and shall retain each such entry for at least three years from the date the generator transports the waste off his site.

(B) Each entry in the log required in subparagraph (A) of this subdivision shall consist of the following:

(i) The name and address of the solid waste facility to which the biomedical waste is transported;

(ii) The weight of (1) untreated and (2) decontaminated biomedical waste transported;

(iii) The date the biomedical waste is transported; and

(iv) The signature of the individual who transports the waste.

(5) A small quantity generator who seeks under subdivision (g) (3) of this section to be exempt from the requirements of subsections (h) and (i) of this section shall:

(A) For each shipment, retain the original U.S. Postal Service receipt and the return mail receipt for at least three years from the date the waste is shipped;

(B) Compile a log which includes an entry for each shipment of biomedical waste and maintain each such entry for at least three years from the date the waste is mailed. Each entry in such log shall consist of:

(i) The weight of (1) untreated and (2) decontaminated biomedical waste mailed;

(ii) The date the biomedical waste is mailed; and

(iii) The name and address of the solid waste facility to which the biomedical waste is mailed.

(6) A generator who treats his own biomedical waste on his site shall compile an operating log which includes an entry for each treatment cycle. Each such entry shall be maintained for three years from the date the waste is treated and shall consist of:

(A) The date and time the treatment cycle begins and ends, and

(B) The weight in pounds of biomedical waste treated during each treatment cycle.

(7) A generator who accepts for treatment at his site biomedical waste generated by another generator or generators shall compile an operating log which includes an entry for each shipment of biomedical waste accepted. Each such entry shall be maintained for three years from the date the waste is accepted and shall consist of:

(A) The date the waste was accepted;

(B) The name and address of the generator who generated the waste;

(C) The weight of (i) untreated and (ii) decontaminated biomedical waste accepted; and

(D) The signature of the individual accepting the waste.

(8) A generator who accepts for treatment at his site biomedical waste generated by another generator or generators subject to the requirements of subsection (h) of this section shall retain copies of the tracking form for three years from the date he accepts waste from such other generator or generators.

(9) A generator who treats his own biomedical waste on his site or who accepts for treatment at his site biomedical waste generated by another generator or generators shall prepare an annual report based on entries recorded in the operating log described in subdivision (6) of this subsection, and stating the total number of treatment cycles performed and the total weight of biomedical waste treated. The annual report shall be submitted to the Commissioner no later than February 15 of each year and shall cover the preceding calendar year. In addition to providing the said information, the generator shall include in the annual report the following information:

(A) His name and address and the address where he treats biomedical waste, if different;

(B) Type of generator he is (for example, general acute-care hospital or clinical laboratory);

(C) Name and telephone number of contact person; and

(D) With respect to each other generator from whom the treating generator accepts biomedical waste:

(i) Type of generator (for example, acute-care hospital or clinical laboratory); and

(ii) Name and telephone number of a contact person.

(E) A statement, signed and dated by the treating generator, which reads: “I have personally examined and am familiar with the information submitted in this document and all attachments and certify under penalty of law that based on reasonable investigation, including my inquiry of those persons immediately responsible for obtaining the information, the submitted information is true, accurate and complete.”

(10) A generator who does not, within 35 days of the date he delivers biomedical waste for transport, receive a copy of a signed tracking form from the solid waste facility to which such waste is to be delivered shall contact such facility and each known transporter of the waste to determine the status of the waste.

(11) A generator who does not, within 45 days of the date he delivers biomedical waste for transport, receive a copy of a signed tracking form from the solid waste facility to which such waste is to be delivered shall submit an exception report to the Commissioner. Such exception report shall be postmarked on or before the 46th day after the date the generator delivered the waste for transport and shall include:

(A) A legible copy of the tracking form as signed and dated by the generator and by the transporter accepting the waste; and

(B) A letter signed by the generator explaining the efforts he has taken to locate the waste and the results of such efforts.

(12) A generator shall retain a copy of an exception report submitted pursuant to subdivision (11) of this subsection for at least three years from its postmark date.

(13) A transporter shall, for each shipment of biomedical waste he transports, retain a copy of each tracking form signed by the generator, himself, any previous transporter, if applicable, and the person to whom he delivers the waste for at least three years from the date he delivers the waste.

(14) A transporter who accepts biomedical waste that is not accompanied by a generatorinitiated tracking form shall, with respect to such waste, retain a copy of the tracking form and related consolidation log initiated by such transporter for at least three years from the date he accepts the waste.

(15) A transporter who accepts biomedical waste that is accompanied by a generatorinitiated tracking form and who subsequently consolidates the waste to a single tracking form pursuant to subdivision (h) (18) of this section shall:

(A) Retain a copy of the generator-initiated tracking form for at least three years from the date he accepts the waste; and

(B) Retain a copy of the tracking form which he initiated and which is signed by the operator of the solid waste facility or subsequent transporter, as applicable, that accepts the waste for at least three years from the date such operator accepts the waste.

(16) A transporter who accepts biomedical waste that is generated in Connecticut or transported to Connecticut for storage, treatment or disposal shall, by each February 15, submit to the Commissioner a report identifying for the previous calendar year: each generator from whom the transporter accepted such waste and each solid waste facility to which the transporter delivered biomedical waste. Such report shall also include the following:

(A) The transporter’s name, address and Connecticut biomedical waste transporter permit number;

(B) The name and telephone number of a contact person for the transporter;

(C) The name, address and type of each generator, by state, from whom the transporter accepted biomedical waste;

(D) The total number of generators, by state, from whom the transporter accepted biomedical waste;

(E) The weight in pounds of (i) untreated and (ii) decontaminated biomedical waste the transporter accepted from each generator, by state;

(F) The name and address of each solid waste facility, by state, to which the transporter delivered biomedical waste generated in Connecticut;

(G) The name and address of each solid waste facility in Connecticut to which the transporter delivered biomedical waste generated outside of Connecticut;

(H) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered to a solid waste facility in Connecticut for treatment or disposal;

(I) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered in Connecticut to another transporter;

(J) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators, by state, which the transporter delivered to a solid waste facility in Connecticut for transfer or storage;

(K) The total weight in pounds of (i) untreated and (ii) decontaminated biomedical waste from all generators in Connecticut which the transporter delivered to a transporter outside of Connecticut or a solid waste facility outside of Connecticut;

(L) The total number of solid waste facilities, by state, to which the transporter delivered biomedical waste; and

(M) A statement, signed and dated by the transporter, which is identical to that set forth in subparagraph (9) (E) of this subsection.

(17) A transporter who initiates a tracking form pursuant to subdivision (h) (17) or (h) (18) of this section is subject to the requirements of subdivisions (10), (11), and (12) of this subsection, except that the 35- and 45-day periods referred to in such subdivisions begin on the day such transporter accepts the biomedical waste in question.

(18) The operator of a solid waste facility that accepts biomedical waste shall retain (A) records compiled pursuant to subdivision (19) of this section and (B) copies of tracking forms and letters retained pursuant to subdivisions (h) (20), (21), and (22) of this section for at least three years from the date such operator accepts the waste.

(19) The operator of a solid waste facility that accepts biomedical waste shall compile written records containing

(A) the name and address of each small quantity generator who delivers biomedical waste to such facility pursuant to subdivision (g) (2) of this section,

(B) the date each waste shipment pursuant to such subdivision was delivered,

(C) the weight in pounds of each such shipment and

(D) the signature of the solid waste facility employee who accepted each such shipment.

(20) The operator of a solid waste facility that accepts biomedical waste in accordance with subparagraph (h) (21) (A) of this section shall retain his copy of the signed and dated shipping paper for three years from the date he accepts the waste.

Florida Medical Waste Regulations

Biomedical Waste – Generators A generator is any facility or person who produces biomedical waste as described in Chapter 64E-16 of the Florida Administrative Code.

All commercial facilities that produce sharps or other biomedical waste are required to obtain an annual permit from the County Health Department of jurisdiction. After 12 months of operation, any facility that has produced less than 25 pounds of biomedical waste each month may apply for exemption from the permit fee at the next permit renewal period.

Annual permit fees are $170.00 per year. The permit year begins October 1 of each year. Call us or your local Health Department for specifics about applying for a permit. An exempt generator is not required to pay the $170.00 annual permit fee but must comply with all other requirements of Chapter 64E-16 of the Florida Administrative Code. Visit the Florida Health Biomedical Web Page to Download the Permit Requirements and a Biomedical Waste Generator Permit Application.

Permitted facilities are inspected annually. Exempt facilities are inspected once every three years. Biomedical waste handling procedures are reviewed to assure proper identification, segregation, containment, storage, labeling, and disposal of biomedical waste.

All facilities must have a Biomedical Waste Plan and provide documentation of annual training in the biomedical waste rule and your plan. Records of disposal must be kept for 3 years and be available for review during inspection.

Biomedical Waste – Storage Facilities The Department of Health regulates treatment methods, other than incineration, and commercial facilities that produce, transport, or store biomedical waste under Chapter 64E-16 of the Florida Administrative Code.

All facilities that transport and/or store or collect biomedical waste, other than what they produce themselves, must obtain an annual storage permit. Transporters, who hold biomedical waste on their truck no more than 72 hours, are exempt from storage permit.

Permits for onsite storage facilities are issued by the County Health Department having jurisdiction for the area where storage facility is located. We issue permits for those facilities located in Orange County. Annual permit fees are $170.00 and the annual permit year begins October 1st. Storage facilities are inspected annually. Download a Storage Permit Application available at Florida Health Biomedical Waste Program Web Page.

Biomedical Waste – Transporters The Department of Health regulates transporters of biomedical waste under the authority of Chapter 64E-16 of the Florida Administrative Code.

Anyone, who transports as much as 25 pounds of biomedical waste at one time over a public roadway, must have a transporter registration from the Department of Health.

Applications for Transporter Registration located available at Florida Health Biomedical Waste Program Web Page should be sent to the local County Health Department of jurisdiction. Annual permit fees are $170.00 plus $10.00 for each transport vehicle over 1. The annual permit year begins October 1.

Transporters are inspected annually and permits are issued by the area Biomedical Waste Coordinators. Transporters must obtain a permit from each county where they have a truck depot.

A list of transporters is available at Florida Health Biomedical Waste Program Web Page.

Transporters must submit an Annual Report of the waste transported along with their renewal for permit each year. The Report form is available at Florida Health.

Biomedical Waste – Treatment The Department of Health regulates treatment methods, other than incineration, and commercial facilities that produce, transport, or store biomedical waste under the authority of Chapter 64E-16 of the Florida Administrative Code.

All Biomedical Waste Treatment facilities and processes, except incinerators, must be approved by the State Department of Health in Tallahassee.

Medical Waste Incinerators are permitted by the Department of Environmental Protection.

After the treatment process has been approved, an initial inspection is performed and a Treatment Permit is issued by the County Health Department having jurisdiction for the location of the treatment facility.

Upon renewal, a Biomedical Waste Treatment Annual Report must be submitted. The Biomedical Waste Annual Report Form is Available at Florida Health Biomedical Waste Program Web Page.

Georgia Medical Waste Regulations

Storage and containment of biomedical waste

For all generators, biomedical wastes should be:

• stored in a manner and location that is protected from weather and animals and does not provide a breeding place or food source for insects or rodents. Exposure to the public should be minimized;

• placed in a container separate from other wastes;

• stored in containers so as to prevent leakage, punctures, and ripping during storage, handling and transportation;

• containers shall be red or orange in color OR clearly marked with the universal biohazard symbol (seen to the right) OR clearly marked with the word “biohazard.”

Treatment and disposal of biomedical waste

Biomedical waste may only be transferred, stored, and treated by EPD-approved facilities with valid operating permits.

When properly treated, biomedical waste is considered a regular solid waste and can be disposed of at a permitted solid waste disposal facility. Proper treatment includes

• incineration,

• decontamination by heating with steam under pressure (autoclave), or

• other methods specifically approved by the Director of the EPD.

The Georgia Rules provide more details on each of these types of biomedical waste treatment.

Fluid or semisolid waste, which means blood and blood products, exudates, secretions, suctionings, and other body fluids which contains free liquids, may be discharged to a municipal sewer treatment system if that system provides secondary treatment of waste. You need to check with your local municipal sewer treatment facility to determine if they can accept these wastes.

Are there any exemptions?

• Generators of biomedical waste from single family residential premises are totally exempt from these rules.

• There is a partial exemption for facilities that generate less than 100 pounds of biomedical waste per month. Biomedical waste from generators of less than 100 pounds per month shall be properly disposed of at a municipal solid waste landfill or permitted treatment facility provided the generator verifies that the receiving landfill accepts this waste. Generators must still comply with the biomedical waste storage and containment rules.

What other agencies regulate different aspects of medical waste management?

• Occupational Safety & Health Administration (OSHA) regulates medical waste exposure to personnel in the workplace

• Department of Transportation regulates medical waste transportation

• Food and Drug Administration (FDA) regulates medical devices such as sharps containers which are designed to safely contain used needles, scalpels or other sharps

• Nuclear Regulatory Commission regulates some types of radioactive medical waste

• US Postal Service (USPS) regulates medical waste in the postal system

The federal Environmental Protection Agency (EPA) has regulations governing emissions from Hospital/Medical/Infectious Waste Incinerators as well as requirements under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) for medical waste treatment technologies that use chemicals for treating the waste.

Where can I go for more information?

• EPA website http://www.epa.gov/wastes/ nonhaz/industrial/medical/

• Healthcare compliance assistance center http://www.hercenter.org/

• Hospitals for a Healthy Environment Practice Green Health website https://practicegreenhealth.org/

• Contact the Georgia EPD at 404-362-2692

• http://www.gecap.org or call GECAP personnel at 404-407-8082

Iowa Medical Waste Regulations

Purpose.

The purpose of this chapter is to implement Iowa Code section 455B.304 and chapter 455D by providing rules for the disposal of special waste. The intent of these rules is to provide safe and proper management for disposal of special waste.

567—109.2(455B,455D) Special waste authorization required.

No special wastes shall be delivered to or accepted by a municipal solid waste landfill unless disposal is authorized by a special waste authorization (SWA) issued by the department. Wastes for which an SWA has been issued shall be disposed of in accordance with the instructions, conditions, and limitations contained in the SWA. An SWA in effect on May 22, 2002, shall remain in effect until the SWA expires or until it is amended. Any amendment requests shall be handled under these rules.

567—109.3(455B,455D) Definitions.

“General special waste” means special wastes that are commonly accepted by landfills and have specific handling requirements for disposal that are explicitly listed in rule 567—109.11(455B,455D). General special wastes are required to be included in the landfill’s special waste acceptance criteria (SWAC), but do not require a special waste authorization (SWA). The following wastes are approved as general special wastes: asbestos-containing material; petroleum-contaminated soil; and stabilized grit, bar screenings and grease skimmings.

“Industrial process waste” means waste that is generated as a result of manufacturing activities, product processing or commercial activities. It does not include office waste, cafeteria waste, or other types of waste that are not the direct result of production processes.

“Municipal solid waste landfill” or “MSWLF” means a discrete area of land or an excavation that receives household waste, and that is not a land application site, surface impoundment, injection well, or waste pile, as those terms are defined under 40 CFR Part 257.2. An MSWLF may also receive other types of the federal Resource Conservation and Recovery Act (RCRA) Subtitle D wastes, such as commercial solid waste, nonhazardous dry sludge, and industrial solid waste. An MSWLF may be publicly or privately owned. An MSWLF may be a new MSWLF site, an existing MSWLF site, or a lateral expansion.

“Pollution control waste” means any solid waste residue extracted by, or resulting from, the operation of pollution control processes.

“Solid waste” is defined in Iowa Code section 455B.301.

“Special handling” means a specific procedure required for handling certain waste to protect the health and safety of employees, the public and the environment.

“Special waste” means any industrial process waste, pollution control waste, or toxic waste which presents a threat to human health or the environment or a waste with inherent properties which make the disposal of the waste in a sanitary landfill difficult to manage. Special waste does not include domestic, office, commercial, medical, or industrial waste that does not require special handling or limitations on its disposal. Special waste does not include hazardous wastes which are regulated under the federal Resource Conservation and Recovery Act (RCRA), hazardous waste as defined in Iowa Code section 455B.411, subsection 3, or hazardous wastes included in the list compiled in accordance with Iowa Code section 455B.464.

“Toxic waste” means material containing poisons, biocides, acids, caustics, pathological wastes, and similar harmful wastes which may require special handling and disposal procedures to protect the environment and the persons involved in the storage, transport, and disposal of the waste.

567—109.4(455B,455D) Types of special wastes. Rescinded IAB 6/11/03, effective 7/16/03.

567—109.5(455B,455D) Applications.

109.5(1) Generators of special waste shall make application for an SWA by submitting the form “Request for Special Waste Authorization” accompanied by supporting data as required by the department. Two copies shall be submitted to the department, and the department will forward one of the copies to the disposal site after the department review process is completed. The application shall include the following information when applicable:

a. Appropriate chemical analysis of the waste,

b. Physical form of the waste,

c. Weight or volume of the waste,

d. Material safety data sheet (MSDS) for the waste or for the materials from which the waste is generated, if applicable,

e. Toxicity characteristic leaching procedure (TCLP) test results when appropriate, which show that none of the federal limits in 40 CFR Part 261 are exceeded, and

f. Any other information requested by the department.

109.5(2) Additional requirements.

a. The waste shall not contain free liquids as defined at 567—100.2(455B,455D). The point of compliance shall be the working face.

b. The waste shall not be a listed hazardous waste or meet the criteria for characteristic hazardous waste pursuant to the federal Resource Conservation and Recovery Act (RCRA).

c. Wastes with PCB concentrations equal to or greater than 50 ppm shall not be authorized for disposal at a landfill.

d. Polynuclear aromatic hydrocarbon (PAH) (SW 846 Method 8270) contaminated soil shall not be authorized for disposal at a landfill if the total PAH level exceeds 1600 ppm for the following compounds: acenaphthene, acenaphthylene, anthracene, benzo(a)anthracene, benzo(a)pyrene, benzo(b)fluornathene, benzo(g,h,i)perylene, benzo(k)fluoranthene, chrysene, dibenzo(a,h)anthracene, fluoranthene, fluorene, indeno(1,2,3-cd)pyrene, naphthalene, phenanthrene, and pyrene or if the total carcinogenic PAH level exceeds 200 ppm for the following compounds: benzo(a)anthracene, benzo(a)pyrene, benzo(b)fluoranthene, benzo(k)fluoranthene, chrysene, dibenzo(a,h)anthracene, and indeno(1,2,3-cd)pyrene or if the cyanide level exceeds 1,000 ppm.

e. Special waste authorizations may be issued for a period not to exceed three years.

567—109.6(455B,455D) Restrictions.

109.6(1) The department may revoke an SWA for cause at any time. Such cause may include, but is not limited to, evidence that indicates that the characteristics of the authorized quality of the waste vary from the authorized values, evidence that the continued disposal of the waste as authorized may pose a threat to the public health or the environment, or failure to comply with any condition in the SWA or the landfill’s SWAC.

109.6(2) The holder of an SWA must apply for a renewal at least 30 days prior to the expiration of the SWA.

109.6(3) The issuance of an SWA does not obligate any waste disposal facility to accept the waste nor does it preclude the facility from imposing conditions or restrictions other than those listed in the SWA.

109.6(4) The issuance of an SWA does not exempt the party disposing of the waste from any local, state, or federal laws or regulations.

567—109.7(455B,455D) Landfill responsibilities.

109.7(1) Any public or private municipal solid waste landfill that refuses any particular solid waste type for management or disposal must identify another waste management facility for that waste within the planning area. In the case of special waste, if no other waste management facility for that waste type exists within the planning area, the city or county, in cooperation with the waste generator, must establish or arrange access to one.

109.7(2) All municipal solid waste landfills shall submit special waste acceptance criteria to the department. The SWAC shall list the different kinds of special waste that each landfill (facility specific) will accept and the instructions for disposal for each of those wastes. The SWAC shall be submitted within 90 days after May 22, 2002. The SWAC shall be submitted on forms provided by the department.

109.7(3) Landfills are required to ensure that special wastes delivered to the facility conform to the SWAC on file with the department.

109.7(4) Each municipal solid waste landfill shall provide to the department, on a_quarterly basis, a report of SWA activity including each SWA number and the quantities of waste disposed of during the reporting period. This information shall be submitted as part of the Quarterly Solid Waste Fee Schedule and Retained Fees Report, Form 542-3276.

567—109.8(455B,455D) Special waste generator responsibilities. Special waste generator responsibilities shall include, but are not limited to, the following:

109.8(1) Prior to submission of an SWA application, the generator shall adhere to the solid waste management hierarchy. Alternatives include volume reduction at the source; recycling and reuse, including composting and land application; and other approved techniques of solid waste management including, but not limited to, combustion with energy recovery and combustion for waste disposal. The generator shall include, as part of the SWA application, a description of the review of the alternatives to landfilling for each waste for which an SWA is requested. The description should detail to what extent the waste could be recycled, reduced or reused so that landfilling is not necessary.

109.8(2) The generator shall follow the guidelines for submission of an SWA application as given in 109.5(455B,455D).

109.8(3) The generator shall ensure that special waste coming into the landfill shall arrive as a separate load and not be commingled with any other waste.

109.8(4) The generator shall submit analytical results supporting an SWA at a frequency to be determined by the landfill.

109.8(5) After receiving an SWA, the generator must contact the designated landfill for instructions on delivering the waste and instructions for adhering to the landfill’s SWAC.

109.8(6) The generator shall notify the department and landfill, prior to disposal, of any change in the characteristics of the special wastes being disposed.

109.8(7) Generators shall notify the landfill in writing when a one-time disposal under an SWA has been completed. This requirement is for one-time disposals only.

567—109.9(455B,455D) Infectious waste. Infectious waste which is generated and treated at a medical clinic, doctor’s office, nursing care facility, health care facility, dentist’s office or other similar facility may be placed with municipal solid waste and not handled in a special way if it is rendered nonpathological, does not contain free liquids, and sharps are shredded, blunted, granulated, incinerated or mechanically destroyed. The generator of the infectious waste must notify the waste hauler and the sanitary landfill that infectious waste is being placed with the regular municipal solid waste and, with the notice, certify that the infectious waste is properly treated in accordance with the requirements of this rule.

567—109.10(455B,455D) Other special wastes.

109.10(1) Radioactive waste. Radioactive materials shall not be disposed of by a sanitary disposal project. Luminous timepieces are exempt.

109.10(2) Sewage sludge.

a. Sewage sludge, including unstabilized septic tank pumpings, shall not be disposed of in a sanitary landfill if it meets the criteria for Class I or II sewage sludge in 567—Chapter 67, except for use in daily, interim, or final cover according to the approved plan for the landfill. Class III sewage sludge may be disposed of at a sanitary landfill as provided in 567—Chapter 112.

b. Sewage sludge may be handled at processing facilities as provided in 567—Chapter 104.

c. Sewage sludge may be utilized for land application in accordance with 567—Chapter 67.

109.10(3) Waste tires. Pursuant to Iowa Code section 455D.11(2), land disposal of waste tires, as defined in 567—Chapter 117, is prohibited as of July 1, 1991, unless each tire is processed by, at a minimum, shredding, cutting or chopping each tire into pieces that are no longer than 18 inches on any side.

567—109.11(455B,455D) Conditions and requirements for the disposal of general special wastes.

109.11(1) Asbestos-containing material. The sanitary landfill permit holder shall comply with the following conditions and requirements whenever asbestos-containing waste materials are accepted and disposed of in a sanitary landfill.

a. Asbestos-containing material (ACM) wastes with 1 percent or less asbestos are not regulated and can be disposed of at the working face, the same as any other waste.

b. ACM wastes that contain greater than 1 percent asbestos are regulated under federal asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP) and shall be managed in accordance with federal regulations defined in 40 CFR Part 61, Subpart M. Testing to determine asbestos content shall utilize the method specified in 40 CFR Part 763, Section 1, Appendix A of Subpart F.

c. Nonfriable ACM waste is defined as waste containing greater than 1 percent asbestos that when dry cannot be crumbled, pulverized, or reduced to powder by hand pressure. Nonfriable ACM waste includes asbestos-containing floor covering and asphalt roofing materials that show no evidence that they contain crumbled, pulverized or powdered ACM residues upon delivery to the landfill.

d. Friable ACM waste is defined as waste containing greater than 1 percent asbestos that when dry can be crumbled, pulverized or reduced to powder by hand pressure. Friable ACM waste includes acoustical, thermal and fireproofing insulation, as well as numerous building products with incorporated asbestos material. Waste transite siding shall be considered friable ACM waste.

e. ACM waste transporters should be encouraged by the landfill operator to notify the landfill at least 24 hours in advance when ACM waste will be arriving at the landfill. Upon arrival at the sanitary landfill, the transportershall present to the landfill operator the ACM waste shipment records, which shall include a determination whether the ACM waste is friable or nonfriable, if known. The landfill operator must through visual inspection or testing verify whether the ACM waste is friable or nonfriable. If not verified as nonfriable, the waste must be handled as friable ACM waste.

f. Any federal NESHAP-regulated ACM waste shipments that show evidence of visible dust emissions or that are not properly containerized, wrapped, wetted, and covered shall be rejected upon arrival at the landfill.

g. ACM wastes with greater than 1 percent asbestos content that are nonfriable when received at the landfill may be disposed of at the working face. Care shall be taken when unloading and covering the waste so that it does not become friable at the working face.

h. ACM wastes with greater than 1 percent asbestos content, as determined by laboratory tests, which are confirmed as friable when received at the landfill shall be disposed of in an area separate from the regular working face. The wastes shall be covered carefully with a minimum of six inches of soil cover and compacted by no later than the end of the operating day. Care shall be taken at all times during disposal and covering to prevent rupture of asbestos-containing containers and wrapped waste systems. Covered ACM waste areas shall be protected from erosion at all times.

i. Upon delivery, friable ACM wastes must be wet and contained in labeled, leak-tight containers or wrapping which prevents asbestosfrom becoming airborne. Bulk demolition wastes with friable ACM need not be placed in leak-tight containers, but must remain wet at all times and be properly labeled and wrapped to prevent asbestos from becoming airborne during transport and disposal and covering at the landfill.

j. Extreme care shall be taken at all times when transporting, depositing, and covering federal NESHAP-regulated ACM waste to control the evolution of dust and airborne asbestos fibers and to not allow the rupture of asbestos containers and wraps.

k. After landfill acceptance, if any federal NESHAP-regulated ACM waste becomes dry prior to disposal, rewetting, or an approved alternative means of dust emissions control, is mandatory. When disposed of, the wet ACM waste must be properly covered before it can dry again.

l. In the event that any visible dust emissions from federal NESHAP-regulated ACM waste occur, protective safety equipment, consistent with federal NESHAP and OSHA regulations, shall be immediately utilized by landfill operating staff.

m. Daily records of the acceptance and disposal of all ACM wastes shall be maintained. Landfill records for each NESHAP-regulated ACM waste shipment shall include the following:

(1) The date of ACM waste receipt.

(2) The names, addresses, and telephone numbers of the originating waste generation site, facility owner, agent responsible for performing removal and the waste transporter.

(3) The description of ACM wastes, quantity in cubic yards, weight and the number and type of containers or systems received.

(4) The waste shipment record and any accompanying asbestos content laboratory test and friable status documentation.

(5) The operational log notation relative to the landfill operator’s visual confirmation of waste type compared to waste shipment records and the friable or nonfriable status for each federal NESHAP-regulated ACM waste shipment.

(6) The operational log notation of any rejected ACM waste and the reasonsfor rejection by landfill staff.

(7) The site operational area, coordinates location and vertical elevation keyed to site mapping and the quantity of buried waste in cubic yards for each federal NESHAP-regulated waste shipment disposed of within the disposal site.

n. Records for all federal NESHAP-regulated ACM wastes accepted at the landfill in accordance with 40 CFR Part 61, including required federal and state asbestos NESHAP program operational and site closure reports, shall be maintained. All records, except for waste shipment records, shall be maintained through site closure. Waste shipment records shall be retained for at least two years.

o. A copy of an Affidavit Explanatory of Title which has been file stamped by the county recorder shall be submitted to the department within 60 days of site closure. The affidavit shall appear at part of the property deed record and shall indicate that:

(1) The landfill has been used for the disposal of ACM waste.

(2) The survey plot and all records of the location and quantity of regulated ACM wastes have been filed with federal and state NESHAP program officials. Such documentation must be filed with the department, along with the notification.

(3) The site is subject to the regulations under 40 CFR Part 61, Subpart M, and the site closure permit requirements issued by the department.

p. Strict adherence to federal NESHAP asbestos regulations under 40 CFR Part 61 is mandatory for all federal regulated ACM wastes. Questions on federal and state regulations should be addressed to the U.S. Environmental Protection Agency at (913)551-7391 or the department’s air quality bureau at (515)281-8443. Questions regarding state asbestos abatement certification requirements should be addressed to the Iowa division of labor services at (515)281-6768. 109.11(2) Petroleum-contaminated soil. The sanitary landfill operator, the generator, and the hauler shall comply with the following conditions and requirements whenever petroleum-contaminated soil is disposed of in a sanitary landfill.

a. The waste cannot be a hazardous waste.

b. The waste cannot contain free liquids as determined by the paint filter liquids test.

c. Upon arrival at the landfill, the hauler shall identify the waste to the landfill attendant.

d. The landfill operator shall direct the hauler to the evaporation area. The soil borrow area or an area with intermediate cover may be used.

e. The contaminated soil may be spread up to a depth of 4 inches. The contaminated soil shall be allowed to aerate for at least 14 days and until the hydrocarbon level is less than 100 ppm. Fourteen days is a minimum. Longer times may be needed if weather conditions are unfavorable or if contamination levels are unusually high.

f. The soil shall be turned or disked at least three times per week.

g. Alternative procedures other than those procedures defined in 109.11(2)“e” and 109.11(2)“f” may be used if it can be demonstrated that soil treatment meeting the requirements of 109.11(2)“h” can be consistently achieved and if approved under permit amendment.

h. After the contaminant has evaporated and the total hydrocarbon content is less than 100 ppm, the soil may be used as daily cover material or incorporated into the working face. The soil may not be used for capping or lining.

i. Once every three months, petroleum-contaminated soil that has been treated at the evaporation area shall be sampled and analyzed for total hydrocarbon content. This sampling can be done at any time during the three-month period depending on the availability of treated soil. 109.11(3) Stabilized grit, bar screenings, and grease skimmings. The sanitary landfill operator, the generator, and the hauler shall comply with the following conditions and requirements whenever stabilized grit, bar screenings, or grease skimmings are disposed of in a sanitary landfill.

a. The waste cannot contain any free liquids as determined by the paint filter liquids test.

b. The generator shall stabilize the grit, bar screenings, and grease skimmings prior to their disposal at the landfill in order to destroy any pathogenic organisms. Stabilization can be done by addition of lime to raise the pH to at least 12 for two hours.

c. The generator shall prearrange a delivery schedule with the landfill operator.

d. Upon arrival at the landfill, the hauler shall identify the waste to the landfill attendant.

e. The landfill operator shall direct the hauler to the working face.

f. The waste shall be deposited at the working face, covered with regular refuse or soil and compacted.

Idaho Medical Waste Regulations

Infectious Medical Waste

This is waste that may be contaminated by blood, body fluids, or other potentially infectious materials. It is likely to transmit infection and endanger human health, agriculture, and the environment. Infectious medical waste is also known as biohazardous waste or regulated medical waste. Examples include:

• Blood-Saturated Waste. Contaminated items that, if compressed, would drip or release blood or other potentially infectious materials in a liquid or semi-liquid state. (Blood-saturated waste is considered infectious; blood-tainted waste is not.)

• Pathological and Anatomical Waste. Tissues, organs, body parts, and body fl uids removed during surgery and autopsy.

• Human Blood and Blood Products. Also known as liquid medical waste. Includes waste blood, serum, plasma, blood products, and other potentially infectious materials.

• Cultures and Stocks of Infectious Agents. Also called microbiological waste. Includes specimens from medical and pathology laboratories; culture dishes and devices used to transfer, inoculate, and mix; and discarded live and attenuated vaccines.

Sharps.• Contaminated hypodermic needles, syringes, scalpel blades, Pasteur pipettes, and broken glass.

• Isolation Waste. Generated by hospitalized patients who are isolated to protect others from communicable disease.

• Contaminated Animal Carcasses, Body Parts, and Bedding. Also includes related wastes that may have been exposed to infectious agents during research or pharmaceutical testing.

Disposal of Infectious Waste

Infectious medical waste should be disinfected before disposal in a properly permitted landfi ll. Disinfected means the waste has been treated by any method used to destroy or kill infectious microorganisms with a potential to cause disease. Effective treatments include:

• Incineration in a facility approved and permitted in compliance with the current requirements of the Idaho air quality rules. The facility should provide temperatures and residence time necessary to destroy all pathogenic organisms. While incineration is an effective treatment, it can expose the public to toxic chemical emissions and endanger human health. It also produces ash that must be disposed of.

• Sterilization by heating in a steam sterilizer, such as an autoclave, at time lengths and temperatures necessary to kill infectious agents within the waste.

• Other methods include chemical disinfection, thermal inactivation, irradiation, and gas/vapor sterilization.

Infectious Waste Disposal Services

Infectious medical waste disposal services are also available through private companies. (Contact DEQ for more information.) These companies pick up infectious medical waste and, before disposal, safely use one of the treament methods described. To make sure that the infectious medical waste is disposed of safely, it is important to verify that the facility in which the waste is disinfected is a permitted facility for that activity.

Additionally, it is recommended that generators of infectious medical waste require companies or persons collecting and disposing of the waste to supply the generator with certifi ed forms documenting proper management and disposal of the waste.

Best Management Practices for Infectious Waste Disposal

The following practices are recommended when disposing of infectious medical waste. If contracting with a medical waste disposal service, it is a good idea to inquire about its practices.

Containers

During storage, handling, and transport, infectious medical waste (except for sharps) must be contained in disposable containers or bags that are moistureresistant and strong enough to prevent leakage or expulsion of solid or liquid waste. Sharps must be disposed of in impervious, rigid, puncture-resistant containers immediately after use.

All bags used for the containment of infectious medical waste must be clearly identifi ed by label or color, or both. Rigid containers of discarded sharps must be labeled in the same way or placed in disposable bags used for other infectious waste.

Vehicles

Vehicles transporting infectious waste should meet all requirements of the U.S. Department of Transportation, and transporters must be knowledgeable in the handling of infectious waste. It is recommended that transporters use equipment that will contain all the waste to avoid releases of infectious waste to the environment and receive training in waste handling and spill cleanup methods

Illinois Medical Waste Regulations

Potentially Infectious Medical Waste General Requirements (PIMW)

How should PIMW be segregated?

PIMW must be segregated into three categories:

Sharps,

Oversized PIMW, and

All other PIMW.

PIMW mixed with other waste is regulated under this Subtitle as PIMW and under any other applicable regulations.

How should PIMW be packaged?

All PIMW which is to be shipped OFF-SITE, except for oversized PIMW, must be placed in containers that are:(1) rigid, (2) leak-resistant, (3) impervious to moisture, (4) of sufficient strength to prevent tearing or bursting under normal conditions of use and handling, and (5) sealed to prevent leakage during transport.

In addition to the requirements listed above, sharps (e.g., needles, pipettes, scalpels, glass) must be packaged in containers that are also puncture-resistant.

Oversized PIMW must be covered or packaged so that contact with transport workers and the public is minimized. Sharps may not be packaged with oversized PIMW.

How should PIMW be labeled?

For persons who package PIMW for OFF-SITE transportation or who accept PIMW packages from off-site:

The generator must mark on two opposite sides of the exterior of the PIMW package (on one side of oversized PIMW), in lettering that is readable at a minimum distance of five feet:

the word ‘BIOHAZARD’,

the word ‘Sharps’ if the package contains sharps, and

the International Biohazard Symbol.

In addition, the generator must securely attach a water-resistant label or tag to each package and write in indelible ink:

Generator’s name,

Generator’s address,

Generator’s phone number (24-hour number, if available).

The transporter must also affix a label to each package in the same manner:

Transporter’s name,

Transporter’s permit number,

Transporter’s address,

Transporter’s phone number (24-hour number, if available), and

For each package, the date when PIMW initially left the generator’s site, or a unique ID number giving that information.

When there is more than one transporter, each transporter must label each PIMW package in this manner. Tags must not obscure any previous information on the package.

Inner packages must be marked with the word ‘BIOHAZARD’, the word ‘SHARPS’ if they contain sharps, and the International Biohazard Symbol.

What are transporters required to do?

Haulers of PIMW are required to have:

A permit issued by the Illinois EPA to transport PIMW (which is different from a special waste hauling permit), if required;

A completed PIMW manifest for the waste, if a manifest is required;

Paid the 1.5 cents/pound PIMW transportation fee, if required; and

The PIMW packaged and labeled properly, prior to transporting it.

The following requirements and fees are applicable to the transportation of PIMW:

HAULING PERMITS

The Illinois EPA collects a $2,000 fee annually for each PIMW hauling permit application and, in addition, collects a fee of $250 for each PIMW hauling vehicle identified in the annual permit application and for each vehicle that is added to the permit during the annual period. The fees must be submitted along with the permit application to Illinois EPA.

MANIFESTS

It is the transporter’s responsibility to carry a completed PIMW manifest. The manifest must be in a form prescribed and provided by the Illinois EPA. The Illinois EPA assesses a fee of $4.00 for each PIMW manifest.

TRANSPORTATION FEE REQUIREMENTS

A 3 cents per pound fee must be collected from:

A person required to have a PIMW hauling permit; or

A person transporting PIMW generated solely by that person’s activity to a site or facility not owned, controlled, or operated by the transporter; or

An owner/operator of a PIMW storage site or treatment facility where the fee has not been previously paid by a transporter.

A person is exempt from obtaining a hauling permit or carrying a manifest if:

The person is transporting PIMW generated solely by that person’s activities, if the PIMW is transported within or between sites or facilities owned, controlled, or operated by that person; or

The person is transporting less than 50 pounds of PIMW at any one time non-commercially; or

The transporter is the U.S. Postal Service.

Transportation standards

The following Transportation Standards apply to persons required to have a PIMW Hauling Permit. PIMW must be transported:

so that the effects of putrescence are minimized;

only in enclosed compartments of vehicles secured against public access (except for oversized PIMW);

with vehicles in good repair and cleaned of visible PIMW contamination after each use;

in a manner that prevents a breeding place or food source for vectors;

so that the integrity of the container is maintained; and

for less than or equal to 10 days.

The Transporter must:

display information in accordance with the PIMW hauling permit;

develop and keep an emergency response plan in the vehicle. This plan must identify the names and phone numbers of State and local authorities who must be contacted in the event of an emergency or discharge. In addition, each vehicle must carry all equipment necessary to provide a response.

not use a vehicle which transports PIMW for the hauling of non-waste materials, except for equipment and supplies intended for the use of waste management (i.e., plastic containers, corrugated boxes, plastic bags, etc.).

Who needs a permit for treatment, storage, or transfer of PIMW?

Treatment, storage, and transfer operations are defined in the Act: treatment facilities are those facilities designed and operated to treat PIMW to eliminate its infectious potential; a storage operation is the containment of waste, either on a temporary basis or for a period of years, in such a manner as not to constitute disposal; a transfer station is a site or facility that accepts waste for temporary storage or consolidation and further transfer to a waste disposal, treatment, or storage facility. Any facility which performs OFF-SITE treatment, storage, or transfer operations will require a permit EXCEPT:

Any person conducting a PIMW treatment, storage, or transfer operation for PIMW generated by the person’s own activities that are treated, stored, or transferred within the site where the PIMW is generated; or

Any hospital that treats, stores, or transfers only PIMW generated by its own activities or by members of its medical staff.

Please refer to Sections 1422.105, 1422.106, and 1422.107 of Subtitle M for details concerning permit applications, including documentation required and certifications necessary. Permit applications may be obtained from the Illinois EPA.

Storage or transfer operations

Any person who stores PIMW prior to treatment or disposal on-site, or transport off-site, either permitted or un-permitted, must comply with the following:

Maintain the integrity of the packaging and provide protection from water, rain, and wind;

Maintain PIMW in a non-putrescent state, using refrigeration when necessary;

Lock the outdoor storage areas containing PIMW to prevent unauthorized access;

Limit access to on-site storage areas to authorized employees;

Store the PIMW in a manner that affords protection from animals and does not provide a breeding place or food source for vectors (i.e., insects and rodents);

Must not compact the PIMW packages or subject them to stress which compromises the integrity of the container;

Multiple generators in the same building may store their PIMW in a common storage area;

Reusable PIMW containers or equipment which are visibly contaminated with PIMW must be cleaned in a designated area;

Copies of all PIMW manifests must be kept at the storage operation for at least 3 years and must be made available to the Illinois EPA upon request.

In addition to the above requirements, facilities which are required to have a storage/transfer permit must comply with the following:

PIMW must be weighed in pounds on a certified scale, unless previously weighed by the transporter;

PIMW must be stored in designated areas, so as not to contaminate other materials;

Cardboard packages must be elevated above the floor in an enclosed area;

PIMW must be stored on a surface that allows drainage and that minimizes exposure to workers and the public;

Adequate aisle space must be maintained between packages to allow inspection of at least one side of each package; labels must be readable. A vehicle containing PIMW is exempt from this requirement:

when loading or unloading, or

when the vehicle is fully loaded.

Either or both of these exemptions must not exceed five days.

Signs must be posted at the points of access to the secured storage area. These signs must display the International Biohazard Symbol and the word ‘BIOHAZARD’ in lettering readable at five feet.

Annual personnel training must be provided to all staff prior to handling PIMW. Training must include a thorough explanation of operating procedures for daily and emergency situations. Records verifying personnel training must be kept.

Storage operations must have a written contingency plan which is to be implemented in the event of a discharge or personal injury. It must include a list of emergency equipment, names and phone numbers of persons qualified to act as emergency coordinator, and procedures for cleanup. A copy must be kept at the storage operation. Emergency phone numbers and a brief description of the emergency procedures must be posted at the operation.

A written operating record must be kept at the facility, including operating parameters, generator information, and quantities and disposition of PIMW.

These records (personnel training and written operating record) must be kept at the storage operation until closure. They must be made available to the Illinois EPA upon request.

Unless otherwise authorized by the Illinois EPA in the permit, PIMW must not be stored for more than:

72 hours unless the surface temperature of the package is maintained at or below 45 degrees Fahrenheit, and

30 days, regardless of the temperature.

At least 60 days before closure, the owner must notify the Illinois EPA. Within 90 days after the final load is received, the owner must certify to the Illinois EPA that closure has been completed in accordance with the permit and all applicable regulations.

Treatment Facilities

Treatment of PIMW must be conducted in a manner that:

eliminates the infectious potential of the waste. A treatment process eliminates the infectious potential of PIMW if the manufacturer/owner/operator demonstrates that an Initial Efficacy Test (IET) and Periodic Verification Test (PVT) have been completed successfully. Refer to Sections 1422.124 and 1422.125 of the Act or the Fact Sheet on Testing Requirements for details on these tests.

prevents compaction and rupture of containers during handling operations, except when this is an integral part of the treatment process;

disposes of treatment residuals in accordance with all applicable regulations;

provides for quality assurance programs that must include a written plan;

provides for periodic testing using biological testing;

provides for assurances that clearly demonstrate that PIMW has been properly treated; and

is in compliance with all Federal and State laws and regulations pertaining to environmental protection.

In addition:

Copies of manifests must be kept at the treatment facility for three (3) years and must be made available to the Illinois EPA upon request;

An annual report must be filed by March 31 by treatment facilities required to have a permit and by those facilities not required to have a permit which treat more than 50 pounds of PIMW per month. This report must specify the quantities and disposition of PIMW treated during the previous calendar year. Forms are available from the Illinois EPA.

Upon closure, the area, equipment, and structures of the facility must be cleaned in accordance with the regulations.

In addition, those treatment facilities required to have a permit must comply with the following:

PIMW must be weighed in pounds on a certified scale, unless previously weighed by the transporter;

Signs must be posted at the points of access to the secured storage area. These signs must display the International Biohazard Symbol and the word ‘BIOHAZARD’ in lettering readable at five feet.

Annual personnel training must be provided to all staff prior to handling PIMW. Training must include a thorough explanation of operating procedures for daily and emergency situations. Records verifying personnel training must be kept.

Treatment facilities must have a written contingency plan which is to be implemented in the event of a discharge or personal injury. It must include a list of emergency equipment, names and phone numbers of persons qualified to act as emergency coordinator, and procedures for cleanup. A copy must be kept at the storage operation. Emergency phone numbers and a brief description of the emergency procedures must be posted at the operation.

A written operating record must be kept at the facility, including operating parameters, generator information, and quantities and disposition of PIMW.

These records (personnel training and written operating record) must be kept at the storage operation until closure. They must be made available to the Illinois EPA upon request.

At least 60 days before closure, the owner must notify the Illinois EPA. Within 90 days after the final load is received, the owner must certify to the Illinois EPA that closure has been completed in accordance with the permit and all applicable regulations.

For treatment facilities required to have a permit, the permit application must include the following information regarding the treatment unit:

an operating plan that includes a description of operating procedures and parameters; and

test data and supporting documentation demonstrating that the infectious potential has been eliminated from either similar existing PIMW treatment units or pilot projects.

A treatment facility must certify to the transporter, if other than the generator, and certify to the landfill operator or receiving facility operator that the PIMW has been treated in accordance with 35 Ill. Adm. Code 1422 and, if applicable, with all terms and conditions specified in its operating permit. Data verifying the efficacy of the treatment unit must be made available to the receiving facility upon request of the receiving facility.

Treatment Unit Requirements

A treatment unit must be:

Designed and operated to eliminate the infectious potential of PIMW as demonstrated by the IET and PVTs;

Operated according to the manufacturer’s instructions, if commercially available;

Operated day-to-day under the same conditions used to demonstrate the elimination of the infectious potential;

Operated with a feed rate not to exceed that used to demonstrate elimination of the infectious potential; and

Designed and operated to limit the emission of microorganisms into the air.

A treatment unit may be used by a treatment facility not required to have a permit if one of the following is met:

The treatment unit meets the above standards and all testing requirements, as defined in these regulations, are met. Proof that the requirements have been met must be kept on file and made available to the Agency upon request.

The treatment facility applies for a voluntary permit.

The treatment facility or manufacturer obtains an adjusted standard from the Illinois Pollution Control Board (IPCB).

Autoclaves, incinerators, and ethylene oxide units installed or operated prior to June 21, 1993 are not required to perform an IET. The first PVT must be performed by September 21, 1993 to demonstrate that the infectious potential has been eliminated.

What should I do with treatment and cleaning residues?

Treatment residuals must be disposed of in accordance with all applicable regulations.

Residues from cleaning and disinfecting anything contaminated with PIMW are regulated as PIMW, except when discharged directly into a sanitary or combined sewer in accordance with 35 Ill. Adm. Code: Subtitle C (Water Pollution). Please note: Local government or sanitary districts may have requirements that are more restrictive than these regulations. The generator of any residue is responsible for checking with the local sanitary district before disposing of any liquid PIMW into the sewer system. Solids are prohibited from disposal into any sewer system.

Residues which have been treated as PIMW in accordance with these regulations are no longer considered PIMW and may go to any municipal landfill, EXCEPT:

ash from incineration, which must be managed as a “special waste” (details of the management of special waste may be found in Section 3.45 of the Act or in the Illinois EPA Fact Sheet on Non-Special Waste Certification);

liquids ONLY may be discharged to the sewer system in accordance with a water pollution permit and local sanitary district regulations;

sharps must be treated to eliminate the infectious potential and be unrecognizable or packaged in accordance with these regulations before they can be placed in landfill.

Untreated medical waste cannot be disposed of into any landfill!

Untreated PIMW is banned from all landfills in Illinois. Once PIMW has been properly treated to eliminate its infectious potential, it is no longer PIMW (except in the case of sharps) and may be disposed of into any landfill permitted by the Illinois EPA to accept municipal waste. For sharps, both the infectious nature must be eliminated and the sharps must either be rendered unrecognizable or packaged in accordance with the regulations prior to disposal. A treatment facility must certify to the transporter, if other than the generator, and to the landfill operator or receiving facility operator that the PIMW has been treated in accordance with 35 Ill. Adm. Code 1422 and, if applicable, with all terms and conditions specified in its operating permit. Data verifying the efficacy of the treatment unit must be made available to the receiving facility upon request of the receiving facility.

Indiana Medical Waste Regulations

Infectious waste is defined by the Indiana Department of Health (IDOH) rules (410 IAC 1-3-10) and Indiana code IC 16-41-16-4 as waste capable of transmitting a dangerous communicable disease. Infectious waste includes pathological wastes, such as tissue, organs and body parts, contaminated sharps, biological cultures, blood and blood products in liquid or semiliquid form, laboratory animal carcasses, body parts, bedding, infectious agent stock, and other waste.

According to IC 16-41-16 and 410 IAC 1-3-22, generators and those who provide services to generators are responsible for proper containment, labeling, effective treatment, transport, and disposal of infectious wastes. IDEM regulates offsite management of infectious wastes by businesses. Infectious waste must be treated or incinerated before it can be disposed of in a Municipal Solid Waste Landfill (MSWLF).

Transporting Infectious Waste Off-Site

Treated and untreated infectious waste will need to comply with labeling and shipping requirements specified in 410 IAC 1-3. All persons and facilities subject to the Infectious Waste rule who are transporting infectious waste off-site, whether effectively treated or not, must:

Required information may be enclosed between the secondary packaging and the outer packaging, when such packaging is used. The outer packaging must contain a biohazard symbol.

Infectious Waste at Transfer Stations and Processing Facilities

A transfer station must not accept infectious waste, except as provided in the Indiana State of Health rule 410 IAC 1-3-26 and 329 IAC 11-13.5-15. A transfer station must have approval to receive treated and/or untreated infectious waste. Any untreated infectious waste accidently received a transfer station needs to be stored and transported off-site as described in 410 IAC 1-3-25 (storage) and 410 IAC 1-3-28 (label and manifest), and shipped in outer packaging with a biohazard symbol label.

If treated infectious waste will be managed at this facility, it must be stored in a secure location separate from the general waste stream until loaded in a transfer trailer. The trailer must be marked with a biohazard symbol label.

Processing facilities accepting treated or untreated infectious waste must have operations plan for tracking labeling, manifests, secure storage area, etc. (329 IAC 11-13.5-15 and 410 IAC 1-3-28).

Treated and untreated infectious waste will need to comply with labeling and shipping requirements specified in 410 IAC 1-3.

IDEM permits treatment of infectious waste like autoclaving, microwaving, ozonation or incineration.

Infectious Waste Treatment

Medical or infectious waste treatment facility must have processing facility permit regulated by 329 IAC 11. IDEM permits treatment of infectious waste like autoclaving, microwaving, ozonation or incineration. A treatment is effective if it reduces the pathogenic qualities of infectious waste designed for specific infectious waste involved and is carried out in a manner consistent with 410 IAC 1.3.

Kansas Medical Waste Regulations

Medical services waste.

(a) “Medical services waste” means those solid waste materials which are potentially capable of causing disease or injury and which are generated in connection with human or animal care through inpatient and outpatient services. Medical services waste shall not include any solid waste which has been classified by the secretary as a hazardous waste under K.S.A. 1982 Supp. 65-3431 and any amendments thereto, or that is radioactive treatment material licensed under K.S.A. 1982 Supp. 48-1607 and regulations adopted under that statute.

(b) Segregation. All medical services waste shall be segregated from other solid wastes at the point of origin.

(c) Storage. All medical services waste shall be stored in a manner and in a container that will prevent the transmission of disease or the causing of injury. Hypodermic needles and syringes, scalpel blades, suture needles, or other sharp objects shall be stored only in a rigid, puncture-resistant container that has been closed to prevent the escape of any material, including liquids or aerosols. All reusable containers used to store infectious waste shall be cleaned and disinfected before each use.

(d) Collection. Medical services wastes shall be collected at least daily from the point of origin for transport to a storage or disposal area or a processing facility. Personnel shall take precautions to prevent accidental contact with the waste during transfer.

(e) Transportation. All medical services wastes transported off-site shall be transported in a manner which will prevent the spread of disease or the causing of injury to persons.

 (1) The waste transporter or disposal firm shall be notified of the types of waste. (2) Containers of medical services waste transported off-site shall be labeled or color coded in accordance with 29 CFR 1910.1030(g)(1)(i), as in effect on July 1, 1996.

(f) Processing. In all processing of medical services waste, dispersal of aerosols and liquids shall be prevented through the use of proper coverings, seals, and ventilation. Personnel shall be protected against contact with the waste through the use of protective clothing and equipment. Medical services waste that has been processed may be combined with other solid waste. Where feasible, all medical services wastes shall be processed before transportation off-site by using either of the following methods:

 (1) Sterilizing infectious wastes by autoclaving or chemical treatment, to destroy the disease- transmission potential; or

 (2) grinding, melting, or pulverizing sharp objects to destroy their injury producing potential.

(g) Disposal. Medical services waste shall be disposed of in a manner which minimizes the risk to health, safety, or the environment. The following shall be considered acceptable disposal methods:

 (1) Discharge of liquids to a sanitary sewer which is connected to a secondary sewage treatment plant;

 (2) incineration of combustible solids, followed by disposal of the ash in a sanitary landfill;

 (3) disposal in a hazardous waste disposal facility which has a permit issued under K.A.R. 28-31-9 K.A.R. 28-31-270; [Note: modified by 28-29-1a] or

 (4) disposal in a sanitary landfill in accordance with the provisions of K.A.R. 28-29-109. (Authorized by and implementing K.S.A. 1996 Supp. 65-3406, as amended by L. 1997,Ch. 139, Sec. 1; effective May 1, 1982; amended, T-84-41, Dec. 21, 1983; effective May 1, 1984; amended July 10, 1998.)

Kentucky Medical Waste Regulations

Medical Waste in Kentucky

Medical waste in simple terms is any waste that may be contaminated by blood, bodily fluids, or potentially infectious materials. Although the EPA provides some oversight of medical waste storage and disposal, the majority of medical waste is regulated on a state or local level.

In Kentucky, there are no specific regulations pertaining to medical waste and there is no one agency with jurisdiction over medical waste. There are, however, regulations that reference the characterization, treatment, handling, labeling, storage, transport and disposal of this type of waste. These state regulations overlap between environmental, public health, labor and transportation agencies. They are intended to protect personnel, the public and the environment from exposure, injury or contamination of potentially infectious wastes.

Management:  Aspects of Medical Waste Management

Characterization: ​Medical waste in Kentucky is characterized as municipal solid waste and is subject to the same disposal requirements; therefore, it can legally be disposed of in a permitted contained landfill according to approved practices. It is important to note, however, that some medical waste may contain toxic chemicals, chemotherapy agents or radioactive materials and may be subject to state and federal regulations specific to hazardous wastes and radioactive wastes.

Generators: Generators of medical waste range from hospitals, nursing homes, clinics and laboratories to h​ouseholds and even illicit drug users.  Depending on the waste generator, treatment may or may not be required to render the waste non-infectious prior to disposal.

Households: Medical waste generated in households may be legally disposed of with regular household garbage. Nevertheless, waste collectors and disposal companies serving this sector should be aware of the potential for medical waste hazards.

Needles and Sharps: Safe disposal methods for needles and sharps generated as household medical waste include the following:

Place needles, syringes, lancets and other sharp objects in a hard plastic or metal container with a screw-on lid. Laundry detergent bottles or metal coffee cans may be used or containers specifically designed for the disposal of medical sharps may be purchased.

​Reinforce the lid of the container with heavy-duty tape, label “Not Recyclable” and place container in regular trash or take it to a household hazardous waste collection event.

Place soiled bandages, disposable sheets, medical gloves and other types of medical waste in securely fastened plastic bags to be placed with regular trash.

Treatment:  Treatment is any method, technique or process designed to eliminate pathogens from potentially infectious waste. Under the Kentucky Cabinet for Health and Family Services regulations, hospitals, nursing homes and certain other public health facilities in Kentucky are required to treat medical waste on or off-site. Basically, this means that items contaminated with a potentially infectious material must be rendered nonhazardous prior to disposal or managed through a medical waste disposal contractor. Infectious waste autoclaves that use steam (moist heat), followed by landfilling, is the most common treatment and disposal method.  Some medical waste is still incinerated; however, the requirements for lower emissions from air pollutants have resulted in less expensive waste disposal alternatives, such as autoclaving.

Handling, labeling, and storing medical waste in the workplace: The risks associated with medical waste are especially important to those exposed to it in their jobs. Such occupations include healthcare, janitorial work, waste collection and landfill workers. The Kentucky Safety and Health (OSH) Program, under the Kentucky Labor Cabinet, regulates several aspects of medical waste including management of sharps, requirements for containers that hold or store medical waste, labeling of medical waste bags and containers, and employee training.

Transportation of medical waste: In Kentucky, anyone who transports solid waste to a landfill is required to register with the Kentucky Transportation Cabinet (excepting from a private residence or a vehicle 10,000 pounds or less).  In addition to vehicle registration, collectors of municipal solid waste, including medical waste haulers, must register with and report annually to any county in which they do business. The registration and reporting form, DEP 5033, may be obtained from county solid waste coordinators or downloaded.

Disposal of medical waste: In Kentucky, medical waste is disposed of in the same manner as household waste, meaning that it can legally be disposed of in a permitted, contained landfill. Treatment and sterilization prior to disposal, however, depends on the type of facility that generates the waste. Hospitals, nursing homes and certain other public health facilities are required to segregate sharps and infectious waste from other waste and then incinerate or render nonhazardous before permanent disposal. Most sanitary landfills in Kentucky will not accept medical waste unless it has been treated at a medical waste transfer station prior to being transported.  Medical waste transfer stations and contained landfills are required to obtain a permit from the Kentucky Division of Waste Management. Permit requirements include the types of waste that may be accepted at contained landfills.

Louisiana Medical Waste Regulations

In Louisiana, there are three (3) sources of regulations for medical wastes: OSHA, the Louisiana Department of Health and Hospitals, and the Louisiana Department of Environmental Quality.

Summary of OSHA Regulations

The following is a partial summary of OSHA regulations regarding occupational exposure to bloodborne pathogens, 29 C.F.R. Part 1910.1030. If your employer is covered by OSHA, it must make a copy of the complete regulations and an explanation of their contents accessible to you. In Louisiana, these regulations apply to all private employers and to federal civilian employers. If the employer has any employees who can be reasonably anticipated to be exposed to infectious material, it must follow these OSHA regulations. According to OSHA’s written enforcement procedures (OSHA Instruction CPL 2-2.44C, March 6, 1992), employees who handle medical waste are considered to have occupational exposure. In general, the rules require employers to develop exposure control plans, to adopt engineering controls and work practices that minimize exposures, to provide handwashing facilities and personal protective equipment, to provide training to workers, to provide hepatitis B vaccines free of charge, to provide medical evaluation and follow-up to exposed workers, and to keep medical and training records.

Under the OSHA rule, exposure means skin, eye, mucous membrane (mouth and nasal) contact with blood or other potentially infectious materials. Blood means human blood, blood products, or blood components. Other potentially infectious materials include all body fluids in situations where it is difficult or impossible to differentiate between body fluids.

Exposure Control Plan Covered employers must prepare an “Exposure Control Plan.” This plan must contain separate lists of job classifications where some or all of the employees may be exposed and a list of job tasks and procedures in which exposure may occur (whether or not personal protective equipment is used). The Exposure Control Plan must also contain a timetable for implementing various provisions of the regulations and a description of the procedure that will be followed if an exposure occurs. The plan must be made accessible to all employees.

Methods of Compliance Section (d) of 1910.1030 specifies the procedures that must be followed by all employers to comply with the regulation. “Universal precautions,” an approach to infection control that assumes that all blood and certain body fluids are infectious for HIV (Human Immunodeficiency Virus which leads to AIDS), HBV (Hepatitis B Virus), and other bloodborne pathogens, must be followed. If the circumstances are such that different body fluids cannot be distinguished from each other, all should be treated as potentially infectious.

Employers are required to employ “engineering and workplace controls” wherever possible to minimize or eliminate employee exposure. Engineering controls either remove the hazard or isolate the worker from exposure. An example of an engineering control is the use of a ventilated cab on earth-moving equipment to protect workers from dust and aerosols. Workplace controls alter the manner in which tasks are performed to reduce exposure-for example, always cleaning equipment with implements or with high-pressure hoses, rather than by hand. Employers are required to examine, maintain, and replace engineering controls on a regular basis to insure their effectiveness.

Personal Protective Equipment Appropriate personal protective equipment must be used to reduce risk of worker exposure. Employers must make readily available at no cost to employees appropriate specialized clothing or equipment to protect against exposure to blood and other potentially infectious materials. Personal protective equipment must prevent such materials from passing through to an employee’s work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time that the equipment is in use.

Personal protective equipment consists of, but is not limited to, gloves, face shields, masks, and eye protection, gowns, aprons, and similar items. Employers must ensure that appropriate personal protective equipment is used and used correctly. Employers must also see to it that personal protective equipment is properly cleaned, laundered, repaired, replaced, or disposed as needed, at no cost to the employee.

The employer must ensure that employees observe precautions for handling and using personal protective equipment, including:

removal of garments penetrated by blood and other infectious material as soon as possible;

placing contaminated protective equipment in designated areas or containers for storing, washing, decontaminating, or discarding each day or shift;

replacing gloves if torn, punctured, contaminated, or if their ability to function as a barrier is compromised;

utility gloves may be decontaminate for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, etc.;

wearing appropriate face and eye protection such as goggles, glasses with solid side shields or chin-length face shields when splashes, sprays, spatters, or droplets of infectious materials pose a hazard to the eyes, nose, or mouth.

Handwashing and Hygiene Employers must provide handwashing facilities that are readily accessible to all employees. When this is not feasible, they must provide antiseptic towelettes. Employers must ensure that employees wash their hands as soon as possible after removing gloves and other personal protective equipment, or after contact with potentially infectious material.

Disposal Methods for Medical Waste at Health Care Facilities The rules provide requirements for handling contaminated sharps, including a requirement that they be placed in a closed, puncture-resistant, leakproof, color-coded (or biohazard-labeled) containers prior to disposal. If the container can leak, it must be placed in a second closed, leakproof container.

Blood and other potentially infectious material (other than sharps) must be placed in leakproof, color-coded (or biohazard-labeled) container before it leaves the facility. If outside contamination occurs, or if the container is punctured, it must be placed in another leakproof, labeled or color-coded container.

Disposal of medical wastes must be in accordance with all applicable federal, state, and local regulations.

Training All persons with a potential for exposure must be provided with adequate training and information including general explanation of the modes of transmission, symptoms, epidemiology, warning signals relating to possible exposure, and procedures to follow if exposure occurs.

Hepatitis B Vaccine Covered employers must make available, free of charge, and at a reasonable time and place, the hepatitis B vaccine and vaccination series to all employees who are at risk of occupational exposure. Employees may decline either antibody pre-screening or vaccination; if they decline vaccination, they must sign a declination form.

If an Exposure Incident Occurs Employees should immediately report exposure incidents. The employer is responsible for establishing the procedure for evaluating exposure incidents.

Recordkeeping The employer must keep medical records and records of training sessions. Medical records must be kept confidential (though an employee and his or her representative may see and copy his own record on request) and must be maintained for thirty (30) years after employment has ended.

Training records, including the dates, content, names and qualifications of trainers, and names and job titles of trainees, must be kept for three (3) years.

Summary of Louisiana Department of Health and Hospitals Regulations

This agency has regulations governing the packaging, labeling, storage, transportation, and treatment of medical waste, contained in the Louisiana Sanitary Code, Part XXVII.

Definitions and Exclusions – The regulations define several categories-medical waste, infectious biomedical waste, and potentially infectious biomedical waste. The latter is used most extensively throughout the regulations, and is defined, in pertinent part, as follows:

“…waste considered likely to be infectious by virtue of what it is or how it may have been generated in the context of health care or health care like activities.”

“Potentially Infectious Biomedical Waste” includes, but is not limited to the following:

Cultures and stocks of infectious agents and associated biologicals, including cultures from medical and pathological laboratories, from research and industrial laboratories.

Human pathological wastes including tissue, organs, body parts and fluids that are removed during surgery or autopsy.

Human blood, human blood products, blood collection bags, tubes and vials.

Sharps used or generated in health care or laboratory settings.

Bandages, diapers, “blue pads,” and other disposable materials if they have covered infected wounds or have been contaminated by patients isolated to protect others from the spread of infectious diseases.

Any other refuse which has been mingled with potentially infectious biomedical waste.

Eating utensils, animal carcasses and bedding, and “very small quantities” (less than 250 grams or 1/2 pound) of human or animal tissue, clean dressings, and clean surgical wastes from persons or animals not known to be infected, are excluded from the definition of potentially infectious biomedical waste. The last two categories of material must be disposed in tightly closed plastic bags or other impervious containers.

Animal carcasses and tissues and wastes from large animals must be disposed either as potentially infectious biomedical waste, or according to regulations of the Livestock Sanitary Board. Carcasses, tissue, and wastes of pets may be buried, rendered [cooked at a minimum temperature of 250 degrees Fahrenheit for at least thirty (30) minutes], incinerated, or disposed either in accordance with these regulations or on the order of a licensed veterinarian.

Packaging and Labeling – Potentially infectious biomedical waste (i.e., medical waste) must be packaged in a manner that prevents exposure to the material. Liquids must be in a sturdy, leak-resistant container. Sharps must be in a closed, rigid, break-resistant, puncture-resistant container. Plastic bags and other containers must be clearly labeled, impervious to moisture, strong enough to prevent tearing or bursting under normal conditions and closed prior to transport. A second level of containment is necessary if the material is to be stored prior to transport.

All containers of potentially infectious biomedical waste must be labeled “Potentially Infectious Biomedical Waste,” “Medical Waste,” or “Infectious Waste.” Untreated waste must bear the name and address of the generator or transporter when it leaves the generator’s premises. Treated waste that is still recognizable must carry a supplemental label to specify the treatment method used, the date of treatment, and the name or initials of the person responsible for treatment. All labels must be clearly visible and legible, and must be water resistant. Note: There are no requirements in the DHH Regulations that state that the bags, boxes, containers, etc., be a certain color.

Storage and Transport – Potentially infectious medical wastes must be stored in a secure manner. Compactors shall not be used for storage. Except for small quantities (defined as a single package containing less than 11 pounds of waste other than sharps or less than 2.2 pounds of sharps), wastes can be transported off the site where they were generated only by transporters permitted by the State Health Officer.

Small quantity generators, including doctors’, dentists’, and veterinarians’ offices and private households, may transport small quantities of properly packaged and labeled wastes to approved large quantity generators, permitted storage facilities, or permitted treatment facilities without meeting the requirements for transport and treatment that large quantity generators must meet.

Transportation of potentially infectious waste (except by small quantity generators, as described above) is governed by Part XXVII.Chapter 7 of the regulations. This section contains provisions for transporter permits; written contracts between generators and transporters; vehicles used in transportation; transporter operation plans (including worker safety and decontamination provisions), and delivery of potentially infectious biomedical waste only to properly permitted facilities.

Special Rules Applicable to Households and Other Small-quantity, Non-healthcare Facilities – Households and other small-quantity, non-healthcare facilities may dispose their waste in the ordinary trash. The waste must be packaged to assure that there will be no leakage, even if the original package is violated (generally, this means double bagging, or placing sharps containers in a second rigid disposal container). Sharps must either be encased in plaster or in another substance as approved by the State Health Officer, or placed in a sharps container of standard manufacture or other similar container of a type approved by the State Health Officer. This sharps container should then be placed in another bag or other rigid container containing a greater volume of non-infectious waste. Note: No labels or symbols are required on these containers.

Treatment and Disposal – Acceptable treatment methods for potentially infectious biomedical waste are set forth in Part XXVII.Chapter 11 of the regulations. These include incineration; steam sterilization [generally, autoclaving at least 248 degrees Fahrenheit (120 degrees C.) and a minimum pressure of 15 psi for a minimum of 30 minutes, or longer if necessary]; disposal of liquids into a sanitary sewer system that meets the requirements of Part XIII of the Sanitary Code; thermal inactivation [dry heat of at least 320 degrees F. (160 C.) at atmospheric pressure for at least 2 hours, excluding lag time]; chemical disinfection (use of chemical agents that have been approved by the State Health Officer); and irradiation (only with the written approval of the State Health Officer).

Sharps must be incinerated, encased in plaster or other approved substances in a tightly closed container, or treated in some other manner that renders them unrecognizable as medical sharps and practically precludes the release of recognizable needles and syringes if compacted.

Once treated, potentially infectious biomedical waste may be disposed in a permitted sanitary landfill in accordance with the Solid Waste Regulations of the Department of Environmental Quality. As noted above, treated and still recognizable medical waste must carry a supplemental label specifying the treatment method and date, and the name or initials of the person responsible for treatment.

On-site Storage and Treatment – Generators may store and treat their own potentially infectious biomedical wastes, if they obtain a proper permit and comply with substantive provisions of the regulations as to packaging, labeling, storage, transportation, and treatment.

Enforcement – These regulations are enforced by the Office of Public Health.

Summary of Louisiana Department of Environmental Quality Regulations

Currently, the Solid Waste Regulations, Louisiana Administrative Code Title 33, Part VII, Chapter 7, paragraph 711.D.1.e, deals with medical wastes. The regulation states that infectious waste from hospitals or clinics may be deposited in Type I or II landfills if it has been properly packaged and identified and is treated by a method approved by the Department of Health and Hospitals. Infectious waste is defined as follows:

“waste that contains pathogens of sufficient virulence and quantity that exposure to it could result in an infectious disease in a susceptible host.”

The La. R.S. 30:2180 D., authorizes the Department of Environmental Quality to promulgate rules and regulations for the transportation, incineration, and disposal of medical waste.

Massachusetts Medical Waste Regulations

Medical or Biological Waste.

Waste that because of its characteristics may cause, or significantly contribute to, an increase in mortality or an increase in serious irreversible or incapacitating reversible illness; or pose a substantial present potential hazard to human health or the environment when improperly treated, stored, transported, disposed of, or otherwise managed.

Storage (A) All medical or biological waste, except sharps, shall be contained in a primary container which is a red, fluorescent orange or orange-red plastic bag that is impervious to moisture and has sufficient strength to resist ripping, tearing, or bursting under normal conditions of use and handling, and which meets the American Society for Testing Materials (ASTM) standard D1922­ 06a and ASTM D1709-04. Each primary container shall:

 (1) Be marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color; and

 (2) Be secured so as to prevent leakage and to preclude loss of contents during handling, storage, and/or transport.

(B) All areas for on-site storage of containers of medical or biological waste, excluding kiosks dedicated for the sole purpose of collecting home sharps pursuant to M.G.L. c. 94C, § 27A, shall be in an uncarpeted room or area with impervious, cleanable, non-absorbent flooring, used exclusively for waste storage.

(C) All on-site storage areas shall:

 (1) Have prominent signage indicating the space is used for the storage of regulated medical or biological waste;

 (2) Be designed or equipped to prevent unauthorized access;

 (3) Be designed or located to protect the waste from the elements and prevent access by vermin;

 (4) Provide sufficient space to allow for clear separation of regulated medical or biological waste from any other waste, when applicable;

 (5) Be adequate to accommodate the volume of regulated medical or biological waste generated prior to removal of waste for either waste transport off-site or on-site treatment, and

 (6) Be maintained such that there is no putrescence or off-site odors, using refrigeration when necessary.

(D) Sharps shall be segregated from other wastes and aggregated immediately after use in red, fluorescent orange or orange-red leakproof, rigid, puncture-resistant, shatterproof containers that resist breaking under normal conditions of use and handling, meet ASTM standard F2132-01, and that are marked prominently with the universal biohazard warning symbol and the word “Biohazard” in a contrasting color.

(E) Free draining blood and blood products and biotechnology by-product effluents shall be stored at all times in leakproof containers that are securely sealed.

(F) Compactors or grinders shall not be used to process medical or biological waste until it has been rendered noninfectious and safe for disposal in accordance with 105 CMR 480.150.

(G) All medical or biological waste, except from home sharps users, must be treated on-site or transported off-site for treatment at a minimum once per calendar year.

Home Sharps (A) Effective July 1, 2012, home sharps, as well as unopened packages of hypodermic needles and lancets, shall not be disposed of in solid municipal waste, including household waste, and shall be collected and disposed of in accordance with 105 CMR 480.125(B).

(B) In accordance with M.G.L. c. 94C, § 27A, federal, state and local agencies as well as businesses and non-profit organizations may establish sharps disposal programs which may include, but not be limited to, the following:

 (1) A program for safe, secure home sharps disposal;

 (2) The establishment of sharps collection centers located at medical facilities and pharmacies;

 (3) The establishment of sharps collection centers located in municipal facilities, including, but not limited to, fire stations, police stations, and public health offices; provided that sharps collection centers may be located at senior centers only for the purpose of disposing of medically necessary hypodermic needles; and

 (4) Medical waste mail-back programs approved by the United States Postal Service.

(C) All mail-back programs shall comply with the United States Postal Service, New Standards for Mailing Sharps Waste and Other Regulated Medical Waste, 39 CFR Part 111.

Sharps Collection Centers

(A) A Sharps Collection Center shall be an identified site within a community that collects and manages home sharps. Operators of Sharps Collection Centers shall be responsible for arranging for the transportation and disposal of home sharps pursuant to 105 CMR 480.000.

(B) In accordance with M.G.L. c. 94C, § 27A , the operator of a Sharps Collection Center shall:

 (1) use only collection containers that meet the requirements of the U.S. Occupational Safety and Health Administration and the U.S. Department of Transportation and are marked with the international biohazard symbol;

 (2) provide secure accessible collection containers on site;

 (3) accept sharps from home sharps users that are in leak-proof, rigid, puncture resistant and shatterproof containers;

 (4) provide appropriate transfer containers for home sharps users who fail to bring their sharps in suitable containers for placement in the collection container;

 (5) have a written agreement with a medical waste transporter providing for regularly scheduled waste pickups; and

 (6) store, handle, transport and treat the collected waste in accordance with 105 CMR 480.000.

(C) Operators of Sharps Collection Centers, excluding kiosks, shall comply with the requirements set forth in 105 CMR 480.100(B), (C), (D), (F) and (G); 105 CMR 480.200(E); 105 CMR 480.300(A), (B), (D), (E) and (F); 105 CMR 480.400; 105 CMR 480.425 (A), (B), (C) and (D); 105 CMR 480.500(A), (B), (C), (H) and (I); as applicable.

(D) A kiosk used as a Sharps Collection Center may be attended or unattended, but shall be dedicated for the sole purpose of collecting home sharps pursuant to M.G.L. c. 94C, § 27A and shall:

(1) meet all of the requirements of 105 CMR 480.135(B)(1), (2), (3), (4), and (5);

(2) be marked and identified as a “Sharps Collection Drop Box” or with an equivalent designation and be clearly labeled with a contact name and emergency contact phone number for an individual(s) who either has knowledge about the specific kiosk including emergency response information, or who has immediate access to a person who possesses such knowledge;

(3) be conspicuously labeled with the international biohazard symbol and the word “Biohazard” in a contrasting color;

(4) be lined with a secondary container designed to prevent spillage, which meets the requirements of 105 CMR 480.300(B)(1), (2), (3), and (4); and

(5) provide written directions in the appropriate language(s), if necessary, for the proper deposit of sharps containers, including but not limited to:

(a) “No loose needles, glass containers or paper/plastic bags”; and

(b) “Please do not leave sharps containers outside the kiosk”.

(E) All kiosk operators shall comply with the requirements set forth in 105 CMR 480.100(C), (D) and (G); 105 CMR 480.200(E); 105 CMR 480.300(A), (B)(5), (D), (E) and (F); 105 CMR 480.400; 105 CMR 480.425(A), (B), (C) and (D); 105 CMR 480.500(A)(3) and (A)(4), (B), (C), (H), and (I); as applicable. Kiosk operators with a written agreement for direct pickup of home sharps by a medical waste transporter in accordance with M.G.L. c. 94C, § 27A shall be exempt from 105 CMR 480.300(F); 105 CMR 480.500(A)(3); and 105 CMR 480.500(C); as applicable.

(F) All Sharps Collection Centers including kiosks shall be inspected by the Board of Health once prior to initial operation to ensure compliance with the requirements of 105 CMR 480.000.

(G) Upon the completion of the initial inspection, the Board of Health shall notify the Department, within 30 days, of the location, and address of the Sharps Collection Center(s), including kiosks.

(H) The Department shall maintain a list of all Sharps Collection Centers, including kiosks, located within the Commonwealth, which are established by the Department or reported by local health officials upon completion of the initial inspection pursuant to 105 CMR 480.135(E).

(I) Collection of home sharps at a Sharps Collection Center shall be the point of generation of the waste. The Massachusetts Department of Environmental Protection may by policy or regulation exempt a Sharps Collection Center from the requirements in 310 CMR 16.00 (Site Assignment for Solid Waste Facilities) and 310 CMR 19.00 (Solid Waste Management), provided that the operator complies with the requirements in 105 CMR 480.135(A), (B), (C), (D), (E) and (F), as applicable.

Approved Disinfection Methods

(A) The following disinfection methods are approved, subject to any additional conditions that may be specified by the Department, to render medical or biological waste noninfectious, excluding pathological waste and contaminated animal waste which shall be disposed of at an approved incineration facility, by interment, or by an alternative method approved in writing by the Department, pursuant to 105 CMR 480.200:

(1) Steam disinfection/autoclaving;

(2) Chemical disinfection;

(3) Incineration at an approved incineration facility; or

(4) Any other method approved in writing by the Department.

(B) The methods which rely on heat shall be evaluated for each load or cycle by using a recording thermometer, thermocouple, parametric monitoring device, thermal indicator strip, or by an equivalent method approved in writing by the Department.

(C) For any wastes that are rendered noninfectious by chemical disinfection, the chemical used shall be of demonstrated efficacy, as determined by the Department, against the challenge testing target or indicator organism and registered with:

(1) The U.S. Environmental Protection Agency, Office of Pesticide Programs pursuant to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA); and

(2) The Massachusetts Department of Agricultural Resources, Pesticide Bureau.

(D) All parametric monitoring equipment utilized in conjunction with any approved disinfection methods, including autoclaves, shall be calibrated at a minimum annually, by an individual who has received training from the manufacturer in the operations and maintenance of the equipment.

(E) Quarterly qualitative (growth/no growth) biological challenge testing shall be conducted during standard operations for all approved disinfection methods including autoclaves, but not incineration.

(1) Testing shall consist of spore strips or a retrievable alternative medium approved by the 4 Department, which contain a 1.0 x 10 minimum challenge population of a bacterial indicator organism that is most resistant to any aspect of the treatment technology as outlined in the most recent medical waste treatment technology guidelines established by The State and Territorial Association on Alternative Treatment Technologies (STAATT) or its successor, The International Society of Analytical Analysis of Treatment Technologies (IStAATT);

(2) Testing methodologies including the number, type and locations shall be in accordance with manufacturers’ guidelines and procedures approved by the Department;

(3) Analytical testing results (growth/no growth) should demonstrate a minimum bacterial spore reduction of 4 log 10 ;

(4) When a 4 log 10 bacterial spore reduction has not been demonstrated (results indicate bacterial growth), an operations and mechanical systems assessment shall be conducted by a qualified individual who has received training from the manufacturer in the operations and maintenance of the equipment. Appropriate corrective actions shall be implemented, when warranted, including but not limited to mechanical adjustments and when applicable, recalibration of all parametric monitoring devices followed by re-treatment of the waste and additional challenge testing to confirm the effectiveness of any implemented corrective action;

(5) In accordance with 105 CMR 480.500(B)(1)(f), the analytical test results shall be documented on the required record-keeping log form for medical or biological waste treated on site in conjunction with the date and all applicable corresponding process parameter results.

(6) When implemented, corrective actions pursuant to 105 CMR 480.150(E)(4) shall be documented in detail including the date, name of the individual implementing the corrective actions and a description of the work performed, on the back of the applicable record-keeping log form for medical or biological waste treated on-site.

(7) All analytical test results shall be retained in the required record-keeping log for a period of three years.

Disposal

(A) Blood and Blood Products.

(1) If the waste generator is connected to a municipal sewerage system or septic system, free draining blood and blood products, except blood saturated materials, may be disposed of directly into these systems unless such disposal is otherwise restricted by the authorized approving agency.

(2) If the waste generator is prohibited by the authorized approving agency from disposing of blood and blood products into the municipal sewerage system or septic system, blood and blood products shall be rendered noninfectious in accordance with 105 CMR 480.150 prior to disposal in a sanitary landfill approved by the Massachusetts Department of Environmental Protection or in case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval.

(B) Pathological Waste. Pathological wastes shall be disposed of at an approved incineration facility or by interment provided however that unprocessed liquid pathological waste may also be disposed of in accordance with 105 CMR 480.200(A).

(C) Blood Saturated Materials, Cultures and Stocks of Infectious Agents and their Associated Biologicals, Dialysis Waste and Laboratory Waste. Blood saturated materials, cultures and stocks of infectious agents and their associated biologicals, dialysis waste and laboratory wastes shall be:

(1) Rendered noninfectious onsite in accordance with 105 CMR 480.150 and disposed of in a sanitary landfill approved by the Massachusetts Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval; or

(2) Placed in a secondary container pursuant to 105 CMR 480.300(B) and stored in accordance with 105 CMR 480.100 prior to transport to an approved off-site facility to be rendered noninfectious in accordance with 105 CMR 480.150.

(D) Contaminated Animal Waste. Contaminated animal wastes shall be disposed of at an approved incineration facility, by proper burial, by interment or by an alternative method approved in writing by the Department. Unprocessed liquid pathological waste may also be disposed of in accordance with 105 CMR 480.200(A) and tissue may also be disposed of in accordance with 105 CMR 480.200(C).

(E) Sharps. Containers of sharps shall either be:

(1) Disposed of by incineration at an approved incineration facility; or

(2) Rendered noninfectious as set forth in 105 CMR 480.150 and processed by grinding or other effective method to eliminate the physical hazard of the sharps and disposed of in a sanitary landfill approved by the Massachusetts Department of Environmental Protection or in the case of out-of-state disposal, approved by the appropriate regulatory agency responsible for landfill approval within that jurisdiction.

(F) Biotechnology By-product Effluents. Biotechnologyby-product effluents that contain RG3 or RG4 agents or are from BSL3 and BSL4 facilities shall not be removed from the site of the waste generator unless all viable microorganisms, whether containing recombinant DNA or not, have been rendered non-infectious in accordance with 105 CMR 480.150. All other biotechnology by-product effluents shall not be removed from the site of the waste generator unless the viable microorganisms including those that might contain recombinant DNA molecules have been rendered noninfectious in accordance with 105 CMR 480.150 however, BSL1 or BSL2 facilities may allow biotechnology by-product effluents that contain RG1 or RG2 agents to be removed from the site prior to treatment if the facility meets the below listed requirements and maintains compliance with the Massachusetts Uniform State Plumbing Code (248 CMR) and the Massachusetts Department of Environmental Protection regulations 314 CMR 7.00 (industrial wastewater permit):

(1) The facility has organized and implemented an Institutional Biosafety Committee (IBC) which is specifically comprised of:

(a) no fewer than five members who collectively have experience and expertise in recombinant DNA technology and/or RG1 and RG2 agents as appropriate, as well as the capability to assess the safety of the biological research; and to identify any potential risk to public health or the environment posed by the biotechnology by-product effluent; and

(b) at least two members, not affiliated with the institution, apart from membership on the IBC, who shall represent the interests of the surrounding community with respect to health and environmental protection (such members may be officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons in the community active in medicine, occupational health, or environmental science).

(2) The Institutional Biosafety Committee (IBC) shall meet, at a minimum, once a year to evaluate the public health and environmental risks associated with all biotechnology-byproduct effluents generated by the facility and to determine the applicability of conditions, including appropriate effluent treatment requirements, for disposal of these wastes according to provisions of the Uniform State Plumbing Code (248 CMR);

(3) The IBC shall make recommendations to management regarding the appropriate effluent treatment requirements for facility waste at least once a year and document those recommendations in the required record-keeping log;

(4) IBC meetings may be open to the public; and

(5) Minutes of all IBC meetings shall be retained as an appendix to the required recordkeeping log, as specified in 105 CMR 480.500(G).

Packaging, Labeling, and Shipping

(A) Every container or bag of waste that has not been rendered noninfectious in accordance with 105 CMR 480.150 shall be colored and labeled according to the requirements of 105 CMR 480.100(A) or 105 CMR 480.100(D), as applicable, to indicate that it contains infectious or physically dangerous medical or biological waste.

(B) Every container or bag of waste which has not been rendered noninfectious in accordance with 105 CMR 480.150 and which will be transported off the premises of the waste generator shall, in addition to the requirements of 105 CMR 480.300(A), be placed in secondary containers which are:

(1) Rigid;

(2) Leak resistant;

(3) Impervious to moisture;

(4) Of sufficient strength to prevent tearing or bursting under normal conditions of use and handling, and

(5) Sealed to prevent leakage during transport.

(C) Prior to transport for off-site disposal, waste which has been rendered noninfectious by a method other than incineration shall be labeled or otherwise marked so as to clearly identify it as noninfectious medical or biological waste and to identify the waste generator responsible for the treatment. Such waste may be disposed of in the same manner as waste which is not regulated by 105 CMR 480.000, except for sharps, which shall be disposed of in accordance with the requirements of 105 CMR 480.200(E).

(D) All shipping of medical or biological waste shall comply, as applicable, with transportation requirements of M.G.L. c. 111, § 31A regarding permitting of waste haulers by local Boards of Health, the United States Postal Service, 39 CFR Part 111, and the U.S. Department of Transportation regulations, 49 CFR Parts 171 through 180.

(E) Waste generators, small-scale generators, and Sharps Collection Centers shall not ship any container of medical or biological waste which shows evidence of leaking or which is otherwise torn or damaged.

(F) Unless there is a more restrictive provision imposed by a Board of Health or the Massachusetts Department of Environmental Protection concerning individuals who are authorized to transport their own waste, small-scale generators and Sharps Collection Centers may transport their own waste, except biotechnology by-product effluents, within the Commonwealth, provided that they do not transport more than 50 pounds every 30 days. Smallscale generators or operators of Sharps Collection Centers shall be responsible for arranging transportation by a dependable individual who has knowledge about the waste being shipped, including emergency response information.

Shipping Papers

(A) Waste generators, small-scale generators that transport their own waste in accordance with 105 CMR 480.300(F), and Sharps Collection Centers shall prepare shipping papers in accordance with 105 CMR 480.400 before shipping waste off-site that has not been rendered noninfectious prior to transport. A designee shall be appointed to prepare, sign and maintain such shipping papers.

(B) The shipping papers shall be signed and dated by the waste generator’s, small-scale generator’s, or Sharps Collection Center’s designee and must include the following information:

(1) The name, address, and phone number of the waste generator along with a contact name and emergency contact number for an individual who either has knowledge about the waste material, including emergency response information, or who has immediate access to a person who possesses such knowledge and information;

(2) A description of the waste to be shipped;

(3) The total quantity of waste to be shipped;

(4) The type of container or containers in which waste is to be transported; and

(5) The destination of the delivery.

(C) All waste generators, including small-scale generators and Sharps Collection Centers, shall maintain a copy of all shipping papers, with the record-keeping log pursuant to 105 CMR 480.500(H), for a period of 375 days after the material is accepted by the transporter, or for any longer period of time as specified in federal hazardous material transportation laws and regulations.

(D) Small-scale generators and Sharps Collection Centers that transport their own waste in accordance with 105 CMR 480.300(F) shall maintain original shipping papers, with the recordkeeping log, for a period of 375 days after the material is delivered to the site of an affiliated generator, or for any longer period of time as specified in federal hazardous material transportation laws and regulations.

(E) Waste generators, small-scale generators and Sharps Collection Centers shall make all shipping papers available upon request by the Department or the Board of Health at all reasonable times.

Tracking Medical or Biological Waste for Treatment

(A) Waste generators, small-scale generators and Sharps Collection Centers shall confirm within 30 days of shipment the receipt at a treatment facility of all medical or biological waste shipped off-site for treatment pursuant to 105 CMR 480.300. Confirmation shall be documented on a paper or electronic medical waste tracking form, approved by the Department. The medical waste tracking form must include all shipping paper information in accordance with 105 CMR 480.400(B), as well as documentation of the treatment facility name, address and telephone number with a contact person who has knowledge about the waste material received or who has immediate access to a person who possesses such knowledge. A completed copy of the medical waste tracking form must be retained with the corresponding shipping paper(s) and the record keeping log required by 105 CMR 480.500(B) for a period of 375 days.

(B) If the waste generator, small-scale generator or Sharps Collection Center does not receive a hard copy or can not access for download an approved electronic copy of the completed medical waste tracking form pursuant to 105 CMR 480.425(A) within 30 days after shipment, the waste generator, small-scale generator or Sharps Collection Center shall report this fact to the Department.

(C) Small-scale generators and Sharps Collection Centers conducting in-state transportation of their own medical or biological waste to an affiliated generator, in accordance with 105 CMR 480.300(F), shall retain the original shipping papers signed by the small-scale generator’s or Sharps Collection Center’s designee and a designee from the affiliated generator receiving the medical or biological waste, in lieu of a medical waste tracking form, for a period of 375 days, pursuant to 105 CMR 480.400(C). In addition, the small-scale generator or Sharps Collection Center shall document all applicable information in the required record-keeping log for off-site treatment pursuant to 105 CMR 480.500(B)(2) and the Department’s Record-Keeping Guidelines for Medical or Biological Waste. The “shipping paper” and “tracking form” boxes should be checked to reflect that both provisions have been satisfied.

(D) Waste generators, small-scale generators, and Sharps Collection Centers receiving medical or biological waste from appropriate and affiliated small-scale generators, or Sharps Collection Centers, shall:

(1) document all applicable information in the required record-keeping log for off-site treatment, if it is to be shipped off-site, pursuant to 105 CMR 480.500(B)(2), and the Department’s Record-Keeping Guidelines for Medical or Biological Waste, with a separate entry dedicated to each delivery received. The “shipping paper,” “tracking form” and “printed name / signature” boxes should remain blank until such time as all of the waste is shipped off-site for treatment. The next shipment for off-site treatment shall include all of the previous medical or biological waste received from small-scale generators or Sharps Collection Centers and any waste generated on-site since the last shipment.

(2) document all applicable information in the required record-keeping log for on-site treatment, if it is to be treated on-site, pursuant to 105 CMR 480.500(B)(1)(b), 105 CMR 480.500(B)(1)(c), and 105 CMR 480.500(B)(1)(g)(i), as well as the Department’s RecordKeeping Guidelines for Medical or Biological Waste, with a separate entry dedicated to each delivery received. The remaining information shall be documented at the time of treatment.

(E) Waste generators or small-scale generators receiving sharps from home sharps users shall:

(1) document all applicable information in the required record-keeping log for off-site treatment, if it is to be shipped off-site, pursuant to 105 CMR 480.500(B)(2), and the Department’s Record-Keeping Guidelines for Medical or Biological Waste, with a separate entry dedicated to each delivery received. The “shipping paper,” “tracking form” and “printed name / signature” boxes should remain blank until such time as all of the waste is shipped off-site for treatment. The next shipment for off-site treatment shall include all of the previous medical or biological waste received from home sharps users and any waste generated on-site since the last shipment.

(2) document all applicable information in the required record-keeping log for on-site treatment, if it is to be treated on-site, pursuant to 105 CMR 480.500(B)(1)(b), 105 CMR 480.500(B)(1)(c), and 105 CMR 480.500(B)(1)(g)(ii), as well as the Department’s RecordKeeping Guidelines for Medical or Biological Waste, with a separate entry dedicated to each delivery received. The remaining information shall be documented at the time of treatment. 480.500: Procedures; Records; Record-keeping Log Waste generators, small-scale generators and Sharps Collection Centers shall:

(A) Develop written procedures, as applicable, for rendering waste noninfectious and to assure effectiveness and compliance with the requirements set forth in 105 CMR 480.000. These shall include:

(1) Procedures for the identification of types, quantities and disposition of regulated medical or biological waste including identification of waste approved for disposal in accordance with 105 CMR 480.200(A)(1);

(2) Procedures for safe handling and transportation within the facility from the point of generation to the point of storage and/or treatment;

(3) Confirmation of U.S. Department of Labor, Occupational Safety and Health Administration’s Bloodborne Pathogen Training for all individuals who may potentially handle medical or biological waste;

(4) The listing of a contact name and emergency contact number for an individual(s) who either has knowledge about the waste material, including emergency response information, or who has immediate access to a person who possesses such knowledge and information; (5) A description of on-site regulated medical or biological waste storage areas, including those used for short term storage, which detail the ventilation and capacity of the storage areas, and the duration waste will be retained in each area.

(B) Maintain a current record-keeping log, on forms provided by the Department or alternate forms, if approved by the Department and which provide at a minimum all of the same required information, for all medical or biological waste either treated on-site in accordance with 105 CMR 480.150 or shipped off-site for treatment, excluding waste approved for disposal pursuant to 105 CMR 480.200(A)(1). The record-keeping log shall have secured, consecutively numbered pages and have on its cover the name of the facility, the name of the owner and operator, if applicable, and in large print the words “Medical/Biological Waste Record-keeping Log”. The record-keeping log forms shall be retained for three years and shall include the information listed below.

(1) The record-keeping log for medical or biological waste treated on-site shall specify:

(a) The exact date of each treatment;

(b) The quantity of waste treated;

(c) The type of waste;

(d) The on-site treatment method with documentation of applicable process parameters including, but not limited to, time, pressure, temperature, and pH;

(e) The printed name and signature of the person responsible for treatment;

(f) Challenge testing/quality control (QC) analytical (growth/no growth) results; and

(g) The following additional information, if applicable:

1. in cases where waste generators, small-scale generators or Sharps Collection Centers receive waste from an affiliated small-scale generator or a Sharps Collection Center, prior to on-site treatment:

a. the exact date that the waste was received;

b. the term “SSG” for small-scale generator or “SCC” for Sharps Collection Center, whichever applies; and

c. the name and address of the affiliated small-scale generator or Sharps Collection Center delivering the waste.

2. in cases where waste generators or small-scale generators receive sharps from a home sharps user prior to on-site treatment:

a. the exact date that the home sharps were received; and

b. the term “HS” for home sharps.

(2) The record-keeping log for medical or biological waste shipped off-site for treatment shall specify:

(a) The exact date of each shipment;

(b) The total number of containers;

(c) The type of waste;

(d) The total combined weight or volume;

(e) The name of the transporter with transporter identification number (if applicable), or:

1. in cases where small-scale generators or Sharps Collection Centers conduct instate transportation of their own medical or biological waste to an affiliated generator:

a. the name and address of the affiliated generator that received the waste in the transporter column; and

b. the term “SSG” for small-scale generator or “SCC” for Sharps Collection Center, whichever applies, in the ID column.

2. in cases where waste generators, small-scale generators or Sharps Collection Centers receive waste from an affiliated small-scale generator or a Sharps Collection Center, prior to shipment off-site for treatment:

a. e name and address of the affiliated small-scale generator or Sharps Collection Center delivering the waste in the transporter column; and

b. e term “SSG” for small-scale generator or “SCC” for Sharps Collection Center, whichever applies, in the ID column.

3. cases where waste generators or small-scale generators receive sharps from home sharps users prior to shipment off-site for treatment, the term “HS” in the ID column.

(f) The verification (via check box) of shipping papers generated with receipt of corresponding medical waste tracking forms for each shipment; and

(g) The printed name and signature of the person responsible for shipping the waste.

(C) Develop, maintain and incorporate into the record-keeping log a written contingency plan for spills and accidents and have available tools and materials sufficient to implement the contingency plan in case of a spill or accident.

(D) Retain results of annual calibration procedures for parametric monitoring equipment with the record-keeping log for three years, if applicable.

(E) Retain results of all analytical Q.C. test results with the required record-keeping log for three years.

(F) Retain with the required record-keeping log, a copy of all applicable registrations and material safety data sheets (MSDS) for chemicals used in approved disinfection methods pursuant to 105 CMR 480.150.

(G) Retain with the required record-keeping log, a list of all IBC members, past and present, with credentials, minutes of all IBC meetings and recommendations of the IBC pursuant to 105 CMR 480.200(F)(3) and 105 CMR 480.200(F)(5).

(H) Retain with the required record-keeping log, copies of all shipping papers with corresponding medical waste tracking forms, or the signed original shipping papers in the case of small-scale generators or Sharps Collection Centers that transport their own waste within the Commonwealth pursuant 105 CMR 480.400(D), for a period of 375 days.

(I) Make all such procedures, records and record-keeping log accessible and available upon request to the Department and the Board of Health at all reasonable times.

Approval of Alternative Methods of Treatment, Storage, and Disposal

The Department may approve, in writing, alternative methods not otherwise authorized by 105 CMR 480.000 for the treatment, storage or disposal of medical or biological waste under the following conditions:

(A) An application has been completed, signed, submitted and accepted by the Department;

(B) The method has been validated through scientific studies acceptable to the Department;

(C) The method has been reviewed and approved by the Department’s Medical and Biological Waste AlternativeTreatment Review Group (MBWAT); and

(D) If the waste is to be transported off-site, the waste treatment facility has been approved by the Massachusetts Department of Environmental Protection or, if shipped out of state, by the appropriate regulatory agency in that state.

Administration and Enforcement

(A) Scope. The following provisions shall cover the administration and enforcement of 105 CMR 480.000 in lieu of 105 CMR 400.000: The State Sanitary Code, Chapter I: General Provisions.

(B) Inspection Authority. In order to properly carry out their respective responsibilities under 105 CMR 480.000 and to properly protect the health and well-being of the people of the Commonwealth, the Department, in the case of generators which are health care facilities licensed by the Department, and the Boards of Health and the Department, in the case of all other generators, or the authorized agent or representative of either, are authorized to enter, examine, or survey at any reasonable time such places as they consider necessary to carry out the provisions of 105 CMR 480.000.

(C) Notices. If as a result of any inspection the Board of Health or the Department finds a violation of 105 CMR 480.000, the Board of Health or the Department shall issue a notice to the waste generator that sets forth the nature of the violation and warns said generator that a second such violation may result in legal action. However, the Board of Health and the Department shall have the authority to initiate proceedings to enforce 105 CMR 480.000 without prior notice in those circumstances in which the board of health or Department determines that there is an imminent risk to public health or safety.

(D) Penalty. Any person who violates any provision of 105 CMR 480.000 other than 105 CMR 480.200 shall, upon conviction, be fined not less than $100 nor more than $500 per day of violation. The penalty for violation of any provision of 105 CMR 480.200 shall, upon conviction, be a fine of not more than $25,000 or up to two years in a house of correction. (E) Injunctions. The Department may seek to enjoin violations of 105 CMR 480.000 pursuant to M.G.L. c. 111, § 127A and to M.G.L. c. 214, § 3(12). Boards of Health may seek to enjoin such violations in accordance with applicable law, including M.G.L. c. 111, § 127A.

(F) Variance.

(1) The boards of health may vary the application of any provision of 105 CMR 480.000 with respect to any particular case when, in its opinion, the enforcement thereof would do manifest injustice; provided that the decision of the board of health shall not conflict with the intent of any minimum standard established by 105 CMR 480.000. No such variance shall be effective until the Board of Health submits it to the Department and it has also been approved by the Department. If the Department fails to comment on the variance within 30 days of receipt, it shall be deemed to be approved. Any variance granted by a board of health shall be in writing. A copy of any such variance shall, while it is in effect, be available to the public at all reasonable hours in the office of the Board of Health.

(2) Any variance or other modification to any of the provisions of 105 CMR 480.000 that are authorized by a Board of Health shall be subject to such qualification, revocation, suspension, or expiration as the board of health expresses in its grant. A variance or other modification to the provisions of 105 CMR 480.000 may otherwise be revoked, modified, or suspended, in whole or in part, only after the holder thereof has been notified in writing and has been given an opportunity to be heard.

(G) Removal of Nuisance by Board of Health. Pursuant to the provisions of M.G.L. c. 111, §§ 122 through 125, a Board of Health may also act to abate any nuisance that is caused by a failure to comply with the provisions of 105 CMR 480.000 thereby endangering or materially impairing the health, safety and well-being of the public, and to charge the responsible person or persons with any and all expenses incurred.

(H) Notice Concerning Violations by Registered Professionals. If the Department or Board of Health issues a notice pursuant to 105 CMR 480.600(C) or obtains a conviction and/or fine pursuant to 105 CMR 480.600(D) with respect to a registered professional, the Department or Board of Health shall notify the appropriate professional registration board.

Severability

If any section, paragraph, sentence, clause, phrase or word of 105 CMR 480.000 shall be declared invalid for any reason whatsoever, that decision shall not affect any other portion of 105 CMR 480.000, which shall remain in full force and effect; and to this end the provisions of 105 CMR 480.000 are hereby declared severable.

Maryland Medical Waste Regulations

Special Medical Waste Also known as biohazardous, infectious, or regulated medical waste, special medical waste is waste that is likely to have been contaminated by an organism capable of causing disease in healthy humans.

The Maryland Department of Health (MDH) regulations, Code of Maryland Regulations 10.06.06, define special medical waste and the criteria by which treatment methods are evaluated (as to whether the treatment creates a regulated or non-regulated waste product).

The Maryland Department of the Environment is responsible for permitting and regulation of all aspects of special medical waste transportation and also requires medical waste handlers to notify MDE of medical waste activity (search for ‘Medical Waste’ on the MDE Land Permit Applications and Instructions page).

Handling of Special Medical Waste.

A person shall handle special medical waste in accordance with the requirements of:

A. 29 CFR §1910.1030(d)(4)(iii)(A) and (B), which is incorporated by reference at COMAR 09.12.31; and

B. COMAR 26.13.12.05 and 26.13.13.

Treatment of Special Medical Waste, Excluding Sharps, Before Disposal.

A. Except as provided in §B of this regulation, a person shall:

(1) Treat special medical waste, excluding sharps, before disposal; and

(2) Use one of the following treatment methods:

(a) Autoclaving;

(b) Chemical disinfection;

(c) Cremation;

(d) Disinfection;

(e) Mechanical destruction after decontamination;

(f) Incineration; or

(g) An alternative method that meets the criteria of Regulation .06 of this chapter.

B. A person may discharge certain special medical waste directly into a sewerage system, without treatment, in accordance with Regulation.07B of this chapter.

Treatment of Sharps before Disposal.

A person shall treat sharps:

A. Before disposal; and

B. By one of the following methods:

(1) Encapsulation;

(2) Incineration;

(3) Mechanical destruction after decontamination; or

(4) An alternative method that meets the criteria of Regulation .06 of this chapter.

Alternative Treatment Systems.

A. Except as provided in §B of this regulation, a person may not use a method for treatment of special medical waste other than those set forth at Regulations .04A(2) and .05B of this chapter.

B. Criteria for Alternative Treatment System. A person may use a method for treatment of special medical waste that complies with the following standards for treatment and microbial test procedures:

(1) The method inactivates vegetative bacteria, fungi, parasites, lipophilic or hydrophilic viruses, and mycobacteria at a 6 log reduction or greater;

(2) The method inactivates bacterial spores at a 4 log reduction or greater; and

(3) The tests have been performed on a representative from each of the following microbial groups:

(a) Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15422);

(b) Candida albicans (ATCC 18804) or Penicillium chrysogenum (ATCC 24791);

(c) Polio 2 or Polio 3 or MS-2 Bacteriophage, (ATCC 15597-B1);

(d) Cryptosporidium spp. oocysts or Giardia spp. cysts;

(e) Mycobacterium terrae, Mycobacterium phlei, or Mycobacterium bovis (BCG) (ATCC 35743); and

(f) Bacillus stearothermophilus (ATCC 7953) or Bacillus subtilis (ATCC 19659).

C. A person may not use a method for treating of special medical waste that:

(1) Creates a threat to health or safety; or

(2) Violates applicable federal and State environmental laws or regulations.

Disposal of Special Medical Waste.

A. Subject to §§B and C of this regulation, a person shall dispose of special medical waste after treatment by one of the following methods:

(1) Interment;

(2) Depositing in a facility approved to accept the type of solid waste being disposed in accordance with §C of this regulation; or

(3) Incineration.

B. A person may discharge a special medical waste that is liquid, semiliquid, or anatomical material that has been mechanically destroyed into a sewerage system, if the discharge is allowed under:

(1) Local ordinance or regulation; and

(2) Environment Article, Title 9, Annotated Code of Maryland.

C. A person shall dispose of special medical waste in accordance with:

(1) State laws and regulations pertaining to solid waste disposal including Environment Article, Title 9, Annotated Code of Maryland; and

(2) Local ordinances and regulations to the extent that the local requirements are not preempted by or in conflict with State law.

Enforcement.

A. The Secretary may enter the property of any person who generates, handles, treats, or disposes of special medical waste to investigate a complaint the Secretary receives regarding the handling, treatment, or disposal of special medical waste.

B. Criminal Penalties.

(1) A person who violates these regulations is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $500.

(2) Each day that a violation exists shall constitute a separate offense.

C. In addition to any penalty under §B, if a person violates these regulations, the Secretary may suspend or revoke any license, permit, or certificate issued to the person under the Health-General Article, Annotated Code of Maryland.

Maine Medical Waste Regulations

BIOMEDICAL WASTE MANAGEMENT RULES

SUMMARY: The rule identifies biomedical waste subject to regulation; requires the registration of biomedical waste generators; and establishes packaging, labeling, handling, storage, transportation, and treatment requirements. The rule does not establish disposal standards for biomedical waste because this rule defines treated biomedical waste as a special waste. The disposal of untreated biomedical waste is prohibited in this rule. The rule requires all transporters and owners or operators of transfer facilities and treatment facilities to obtain a license. The rule specifies siting, design, operating and reporting requirements and establishes a biomedical waste tracking or manifest system.

Treatment Methods for Biomedical Waste

Biomedical waste must be treated as follows:

A.  Pathological waste must be incinerated, interred or treated by a treatment technology approved by the Department pursuant to Section 19.

B.   Discarded blood, blood products and body fluids must be (1) incinerated, (2) discharged through a sewer to a publicly owned treatment works (POTW), provided that it is discharged in accordance with the state’s water quality laws and local ordinances, (3) discharged to a septic system, provided that the septic system is in compliance with state rules and standards and provided that it is discharged in compliance with local ordinances, or (4) treated in a licensed biomedical waste treatment facility using non-incineration technology approved by the Department pursuant to Section 19.

C.   All other biomedical waste must be incinerated or treated by a non-incineration treatment technology approved by the Department pursuant to Section 19.

NOTE: The Department recommends that discarded cultures and stocks of infectious agents, (see Section 7(A)(5) of these rules) to be transported off-site for treatment be pre-treated by steam sterilization to reduce the concentration of pathogens prior to packaging in accordance with Section 12(A) of this rule.

D.  All incineration of biomedical waste must be in a licensed biomedical waste incinerator.

11. Registration of Generators

A.  Registration

(1)  Each medical facility which generates a biomedical waste shall register with the Department on forms available from the Department at least 30 days prior to the date such generation is expected to commence.

(2)  The Department will assign a biomedical waste generator registration number to each medical facility which registers with the Department and will notify each such facility in writing of such assigned registration number. Upon receiving such notification, the facility shall include the assigned registration number in or on manifests, labels affixed to packages of biomedical waste, and tags enclosed in each package of biomedical waste.

(3)  Facilities which generate biomedical waste shall notify the Department in writing within 30 days of a change in majority ownership, name, location or operational status of the facility.

(4)  The registration numbers assigned under this subsection are not transferable.

(5)        The initial registration fee will be $50 per facility.

(6)  Biomedical waste generators will be assessed an annual fee based on the average amount of biomedical waste produced per month.

(a)  Generators producing less than 10 pounds per month will pay an annual fee of $25.

(b)  Generators producing 10 pounds or more, but less than 50 pounds per month will pay an annual fee of $50.

(c)  Generators producing 50 pounds or more per month will pay an annual fee of $500.

B.   Biomedical Waste Management Plan

(1)  Except as provided for in Section 4 of this rule, each medical facility which generates biomedical waste shall prepare a written biomedical waste management plan appropriate for the size and type of facility. Such plan must set forth policies and procedures consistent with these regulations for managing biomedical waste.

(2)  The biomedical waste management plan must include, at a minimum, the following:

(a)  a description of the biomedical waste generated by the medical facility including type and volume of biomedical waste;

(b)  a description of any biomedical waste handling procedures, in addition to those required by this rule, which are specific to that medical facility including such information as location of storage area, etc.;

(c)  the treatment methods for each type of biomedical waste;

(d)  personnel training procedures;

(e)  spill containment and cleanup procedures and equipment; and

(f)  the name, address, and telephone number of the person(s) responsible for biomedical waste management at the medical facility.

(3)  The medical facility shall certify, at the time of registration, that a biomedical waste management plan has been developed for the facility.

(4)  The medical facility biomedical waste management plan must be available for inspection by a public safety officer or authorized representative of the Department.

12. Standards for Generators

A.  Packaging

Biomedical waste must be properly packaged to assure effective containment throughout the handling, storage, transport, and treatment processes.

(1)  Biomedical wastes, other than sharps and bulk liquids, must be packaged in bags which are impervious to moisture and have a strength sufficient to resist ripping, tearing or bursting under normal conditions of usage and handling.

(2)  All bags containing biomedical waste must be red in color and imprinted with the international biohazard symbol and the words “biomedical waste” or “infectious waste.” Waste in red bags will be considered biomedical waste and must be managed as biomedical waste.

(3)  Bags must be sealed by forming a secure closure which results in a leak-resistant seal.

(4)  Discarded sharps must be segregated from other biomedical waste at the point of generation. Discarded sharps will be placed directly into leak-resistant, rigid, puncture-resistant containers without clipping or breaking. When full or in preparation to be sent for treatment, these containers will be taped closed or tightly lidded to preclude loss or leakage of contents. After proper packaging, sharps containers may be placed in biomedical waste bags referred to in Section 12 (A)(1) of these rules.

NOTE: An example of an acceptable container for storing discarded sharps at home is an empty rigid plastic bottle.

(5)  Discarded bulk blood and other liquids which is to be transported off-site will be packaged in tightly stoppered, unbreakable flasks or bottles or other appropriate containers.

(6)  All biomedical waste bagged in accordance with Section 12(A)(3), sharps containerized in accordance with Section 12(A)(4), and bulk liquids containerized in accordance with Section l2(A)(5) which are to be transported off-site must also be packaged for storage or handling by placement in disposable corrugated fiberboard boxes or equivalent rigid containers such as reusable pails, cartons, drums, or portable bins. The box or container must be leak-resistant or lined with a bag which is impervious to moisture and has a 200-pound burst strength as measured by the industry’s Mullen test.

(7)  Reusable containers used for the handling of biomedical waste must be thoroughly washed and disinfected each time they are emptied unless the surfaces of the containers have been effectively protected from contamination by disposable liners, bags or other devices which are removed and disposed of with the waste.  A red bag may not be enclosed in a bag of another color.

(8)  Reusable containers used for the handling of biomedical waste must not be used for containment of waste to be disposed of as non-biomedical waste or for any other purpose except after being disinfected.

B.   Labeling

Biomedical waste to be transported off-site must be labeled immediately after packaging in accordance with Section 12(A)(6). The label must be securely attached to the outer layer of packaging and be clearly legible. Indelible ink will be used to complete the information on the label, and the label will be at least three inches by five inches in size. The following information must be included on the label:

(1)  The name, address, business telephone number, and registration number of the generator;

(2)  “Biomedical Waste” or “Infectious Waste” in large print;

(3)  “Refrigeration Required” in large print if pathological waste, cultures, or animal carcasses or body parts are included in the contents;

(4)  The name, address, business telephone number, and registration number of the person or persons to whose control the biomedical waste is to be transferred;

(5)  The international biohazard symbol; and

(6)  The date upon which the biomedical waste was packaged in accordance with Section 12(A)(6).

C.  Handling

(1)  Packages of biomedical waste must be handled in a manner that does not impair the integrity of the packaging.

(2)  Trash chutes will not be used to transfer biomedical waste between locations where it is contained.

(3)  Compactors must not be used in the handling of biomedical waste. Biomedical waste in bags or other containers must not be subjected to compaction by any compacting device and must not be placed for storage or transport in a portable or mobile trash compactor.

D.  Storage

(1)  Biomedical waste must be segregated from other wastes.

(2)  All on-site storage of containers of biomedical waste must be in a designated area away from general traffic flow patterns and, where possible, in a room reserved for this purpose. The manner of storage must prevent access to or contact with such waste by unauthorized persons.

(3)  Biomedical waste must be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and/or putrefaction. Pathological waste, cultures, and discarded animal carcasses and body parts stored for more than 24 hours after packaging in accordance with Section 12(A)(3) must be refrigerated at a temperature of 45° F or below in a refrigerator or refrigerated space used only for biomedical waste.

(4)  All areas used for the storage of biomedical waste must be capable of being readily maintained in a sanitary condition.

(5)  All biomedical waste containers must be stored in a manner that allows access for inspection.

(6)  Biohazard signs must be posted wherever biomedical waste is stored or contained, including on storage rooms doors, refrigerators, bins and other containers.

E.   Manifests and Record Keeping Requirements

(1)  Except as provided for in Section 4, the generator of biomedical waste that is to be transported off-site for treatment or disposal shall initiate a biomedical waste 4‑part manifest available from the Department. Copy 4 of the biomedical waste manifest is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the transfer or treatment facility; and Copy 1 is to be returned to the generator.

(2)  If the generator does not receive the completed manifest from the treatment facility within 35 days after the date the waste was accepted by the transporter, the generator shall report this fact to the Department.

13. Licensing of Transporters

A.  Applicability

No person may transport biomedical waste without first obtaining a biomedical waste transporter license from the Department unless:

(1)  exempted pursuant to Section 4, or

(2)  the biomedical waste is moved in the site where it is generated or in the site of a license transfer or treatment facility.

B.   Application Requirements

(1)  Application for a biomedical waste transporter license must be made on a form obtained from the Department.

(2)  All persons transporting biomedical waste shall apply to the Department at least 30 days prior to the date they wish to begin transporting biomedical waste and must obtain a license prior to transporting.

(3)  A transporter may apply for a license to cover himself as an operator and all conveyances which he or she either owns or leases for the purpose of biomedical waste transport. Where such an application is made and a single license issued, a license certificate must be obtained from the Department for the operator and for each conveyance covered by the license.

(4)  A transporter which is a business that engages in the transportation of biomedical waste may apply for a transporter license to cover all locations of the business; all conveyances owned, leased or otherwise controlled by the business and used for the transportation of biomedical waste; and all operators of such conveyances employed by the business. Where such an application is made and a single license issued, a license certificate must be obtained from the Department for each business location, each conveyance and each operator covered by the license. The requirements of this rule apply to the entire license and/or to the separate business locations and/or to the separate conveyances and/or to the separate operators covered by the license.

(5)  An applicant or licensee shall immediately notify the Department in writing of any change in circumstance or situation which changes or will change any information stated on his application.

(6)  The applicant must submit:

(a)  Evidence of an applicant’s history of compliance with laws, regulations and standards relating to environmental protection.

NOTE: For example, the Department will require the applicant to provide a list of all environmental licenses or permits previously obtained by the applicant in this, or any other, State as well as information pertaining to the status of those licenses or permits or to any related enforcement actions.

(b)  Records pertaining to the operation of motor vehicles.

(c)  A certificate of liability insurance covering the licensed activity in an amount appropriate for the licensed activity and for the risk involved. In no event, however, may the limit of liability be less than $1,000,000.

(d)  A spill plan for the cleanup of discharges of biomedical waste that the applicant proposes to transport and evidence of the capability to carry out the plan.

(e)  Any other information, including safety histories and training programs, which the Department deems to be necessary.

(7)  The application must be signed by:

(a)  A principal executive officer of at least the level of vice president, if the applicant is a corporation.

(b)  A general partner or a proprietor, if the applicant is a partnership or sole proprietorship.

(c)  A principal executive officer or ranking elected official, if the applicant is a municipal, state, federal or other public agency.

(8)  The application fee schedule follows:

(a)  An application fee of $100 must accompany each application for an initial or renewal license.

(b)  If an applicant is applying for a license to cover more than one conveyance, and/or more than one operator and/or more than one business location, he or she must submit with the application an additional fee of $50 for each additional conveyance, operator or business location.

(c)  Application fees for additional conveyances, operators or business locations will be reduced to $25 if the date of issuance of any license certificate is within six (6) months of the expiration date of the license.

(d)  Application fees are non-refundable.

(9)  Application for renewal of a license must be made no sooner than ninety (90) days and no later than 30 days prior to the date of its expiration and will be made on forms provided by the Department. A copy of a prior application may, at the discretion of the Department, be submitted as the renewal application provided there has been no change in the information included therein or required by this rule. The applicant shall accompany the copy with a recent certificate of insurance, and a letter, signed and dated by the applicant, that states there have been no changes.

C.  Decisions

The Department shall issue a biomedical waste transporter license whenever it finds that the applicant has satisfied all application requirements and has demonstrated the technical and financial ability to comply with the operating requirements and manifest and recordkeeping requirements of this section, all terms and conditions of the license, and all other requirements of this rule.

D.  Terms

(1)  A license or renewal of a license granted under this rule is valid for one calendar year beginning with the date of issuance. Business location license certificates, conveyance license certificates and operator license certificates issued with the initial license or added thereafter as provided by this rule will also expire on the date the license expires.

(2)  A license under this rule is issued on the basis of information supplied in the application and is valid only so long as that information remains accurate. Where the Department has been notified of a change in the information, the license remains valid notwithstanding the change, so long as the licensee complies with any additional or different terms and conditions of the license necessitated by the changed information.

(3)  A license under this rule is issued only to and for the persons, conveyances, locations and activities specified in the license and is non-transferable. Operators who are no longer employed by the licensee and conveyances which are no longer owned, leased or otherwise controlled by the licensee are no longer covered by the license and must not be used to transport biomedical waste. Any certificate issued to such operators or conveyances must be returned to the Department within 10 calendar days of the date of change.

(4)  A conveyance used to transport biomedical waste may be inspected at any time for compliance with its license and these rules, and for adequacy for safe transportation of biomedical waste. Inspection may be made by a public safety officer or any authorized representative of the Department. A conveyance found to be not in compliance with this rule or to be otherwise unsafe may not thereafter be operated except under the direction of a public safety officer or an authorized representative of the Department.

E.   Standard Conditions

All transporter licenses issued under this rule are subject to the following standard conditions:

(1)   Duty to Comply. The licensee shall comply with all conditions of the license and these rules. Noncompliance with the license or rule constitutes a violation and is grounds for enforcement action, for license suspension or revocation, or for denial of any renewal application.

(2)   Liability Insurance. A licensee shall have liability insurance coverage in force at all times during the term of the license. The coverage must be appropriate for the licensed activity and for the risk involved. Under no circumstance may the amount of liability insurance in force be less than $1,000,000.

(3)   Local, State and Federal Permits. A licensee shall hold all other local, state and federal permits, licenses and certifications required for the licensed activity and shall comply with all applicable local, state and federal laws and rules.

(4)   Record Keeping. A licensee shall comply with all applicable state and federal requirements regarding the use of a manifest and the maintenance of other required records.

(5)   Duty to Ensure Safe Operation. It is the duty of a licensee to ensure that the licensed activity is carried out safely and does not create a threat to public health or safety or the environment. A licensee shall ensure that all methods, equipment and personnel are adequate and capable to achieve this end.

(6)   Inspection and Training Requirements. A licensee shall comply with all state and federal inspection and training requirements as may from time to time be applied by law, rule or license condition to the licensed activity.

(7)   Response to an Emergency. A licensee agrees to provide to the Department and to public safety agencies all information necessary for response to emergency situations involving the licensed activity and agrees to assist the Department in obtaining compliance with this rule.

(8)   Spill Plan. The operator of a conveyance must be familiar with the spill plan for the conveyance and for the wastes in the conveyance which he or she is operating and shall be capable of carrying out the plan.

(9)   Discharge of Biomedical Waste. In the event of a discharge of biomedical waste in any amount, the licensee shall take immediate appropriate action to protect public health, safety and welfare and the environment, including immediate implementation of the approved spill plan, and shall immediately report the discharge to the Maine Department of Environmental Protection.

(10) Duty to Mitigate. The licensee shall take all reasonable steps to minimize or correct any adverse impact on the environment resulting from noncompliance with the license.

(11) Duty to Reapply. If the licensee wishes to continue an activity regulated by the license after the expiration date of the license, the licensee must apply for and obtain a new license.

F.   Special Conditions

The Department may place special conditions on any license issued under this rule. However, special conditions must address particular means of satisfying minor or easily corrected problems relating to compliance with this rule and with all applicable statutes and may not substitute for or reduce the burden of proof on the applicant to affirmatively demonstrate to the Department that each of the applicable standards has been met.

G.  Suspension or Revocation

(1)  The Department may seek suspension or revocation of a license pursuant to 38 M.R.S.A. Section 341-D(3).

(2)  Suspension or revocation may be sought as to any or all operators, conveyances or locations covered by the license.

(3)  Where a license covers more than one operator and/or conveyance and/or location and if two or more operator, conveyance and/or location licenses covered thereunder are suspended within a calendar year, the Department may seek revocation of the entire license.

(4)  The Department shall seek revocation of any license which is again suspended within 18 months of its prior suspension or revocation.

(5)  A licensee whose license has been revoked may not reapply for a license until the conditions or violations which led to the revocation have been eliminated.

14. Standards for Transporters

A.  Operations

(2)  Except as stated in Section 4 of this rule, biomedical waste shall only be transported from the point of generation by transporters who are licensed by the Department.

(1)  The packaging, labeling, handling, and storage requirements specified in Sections 12(A), 12(B), 12(C), and 12(D) of this rule, apply to the transportation of biomedical waste.

(3)  No person may transport or receive for transport any biomedical waste that is not packaged and labeled in accordance with these rules.

(4)  Conveyances that transport biomedical waste must include a cargo-carrying portion that must be closed and secured except when loading or unloading waste to prevent unauthorized access and exposure to wind and/or precipitation; must be designed and constructed so as to contain any spillage; must be cleaned and disinfected following leakage or spills; and must be cleaned and disinfected prior to using the conveyance for any other purpose.

(5)  The identity of the biomedical waste hauler and the international biohazard symbol must appear on three sides and the door of the cab of conveyances used to transport biomedical waste. The lettering of such identification must be clearly legible during daylight from a distance of 50 feet.

(6)  The transporter license certificate, or certified copy thereof obtained from the Department, must be available for inspection upon demand by any public safety officer or any authorized representative of the Department.

(a)  A certificate covering an operator must be in his or her immediate possession while he or she is engaged in the transportation of biomedical waste.

(b)  A certificate covering a conveyance must be with the conveyance while it is engaged in the transportation of biomedical waste.

(c)  A certificate covering a business must be prominently displayed at each location of the business.

(7)  Vehicles used to transport biomedical wastes must carry an appropriate spill containment and clean up kit.

(8)  Biomedical waste must not be compacted or subjected to violent mechanical stress during transport.

(9)  Biomedical waste may not be transported in the same vehicle with other waste unless the biomedical waste is separately contained in rigid reusable containers or kept separate by barriers from other waste, or unless all of the waste is to be treated and disposed of as biomedical waste in accordance with this rule.

B.   Manifests and Record Keeping

(1)  A transporter may not accept biomedical waste from a generator unless it is accompanied by a manifest with the generator portion completed, signed and dated by the generator.

(2)  A transporter shall in the presence of the generator or, for subsequent transporters, the prior transporter, complete the appropriate transporter portion of the manifest, including handwritten acceptance signature and date of acceptance, and immediately give a signed copy of the manifest to the generator or prior transporter, noting any discrepancies in manifest information.

(3)  Copy 4 of the 4-part biomedical waste manifest is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the transfer or treatment facility; and Copy 1 is to be returned to the generator.

(4)  Retention of Records. Manifests must be retained by the licensed biomedical waste transporter for a period of not less than three (3) years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Department. These records must be made available for inspection by the Department, upon request.

Michigan Medical Waste Regulations

I. REGULATED MEDICAL WASTE (MW) INCLUDES:

• Cultures and stocks of infectious agents.

• Human and animal blood and body fluids.

• Sharps.

• Pathological waste (organs, tissues, etc.).

• Contaminated animal waste infectious to humans.

II. CERTIFICATE OF REGISTRATION

Required for facilities that produce any volume of medical waste, and expires every 3 years; renewal applications are sent to facilities automatically. Registration fees vary between $50 to $150 per renewal depending upon the facility type. Initial applications are also available on the MW Web site for new applicants.

III. MEDICAL WASTE MANAGEMENT PLAN

Required of all medical waste producing facilities. Must list and describe the type(s) of medical waste produced and method(s) of packaging, storage, treatment, and disposal used for each medical waste type. The facility must have on file on the premises and make available to the DEQ during inspections. A sample plan is on the MW Web site.

IV. EMPLOYEE SAFETY & RECORD OF TRAINING

Proper personal protective equipment and universal precautions should be practiced at all times to prevent risk of infection and exposure to employees. A record of training for all employees handling medical waste at the facility must be documented in accordance with the facility Medical Waste Management Plan and made available upon inspection for a minimum of 3 years.

V. PACKAGING & STORAGE

Appropriate bags, containers, and packaging should be in use at all times for proper medical waste segregation and safety. See Part 138 of Act 368 for the packing and storage requirements and a list of disposal vendors online at www.michigan.gov/deqmedwaste. Medical waste may be stored at a producing facility no longer than 90 days (including sharps). The storage period begins on the date when the container use is initiated.

VI. SHIPMENT RECORDS

Documentation that verifies regulated medical waste is removed from the facility and properly treated and disposed every 90 days is required to be made available upon inspection for a minimum of 3 years.

Minnesota Medical Waste Regulations

Managing infectious waste

Planning

If you are a regulated infectious waste generator, prepare and maintain an Infectious Waste Management Plan and update it at least every two years. Keep a copy of the plan at your site. Ensure your plan includes:

· Name and address of the generating facility

· Types of infectious or pathological wastes generated

· Collection, storage, transport, and disposal methods used for infectious wastes

· Packaging and labeling of infectious wastes

· Transporters and disposal facilities used for infectious wastes

· BBP exposure control plan, or the steps you have taken to minimize potential employee exposure

· Name of the individual responsible for implementation of the management plan

· Amount of infectious and pathological waste generated in the previous two years

Do not submit a copy of your plan to the MPCA except in response to an explicit request. The Minnesota Department of Health (MDH) no longer reviews plans or issues acknowledgment cards.

On-site storage

In general, storage requirements at the site of generation are regulated under the BBP; however, the MPCA requires that the storage methods used, including packaging and labeling, are described in your infectious waste management plan. Comply with your management plan.

Disposal

The four allowed disposal methods for regulated infectious waste in Minnesota are discussed in detail below:

1. Decontaminate your site’s infectious waste at that site

2. Discharge liquid infectious waste to a sanitary sewer or subsurface treatment system

3. Transport your own infectious waste to another site for decontamination

4. Ship your infectious waste to another site for decontamination using a Commercial Infectious Waste Transporter registered with the MPCA, or mail it to a disposal facility with the U.S. Postal Service

1. Decontaminate your site’s infectious waste at that site

Decontaminate means to treat an infectious or pathological waste to make it safe to manage as a normal solid waste. Decontamination must be verified by standard biological indicators, such as Geobacillus stearothermophilus and Bacillus atrophaeus spores. Simply enclosing an infectious waste within a container or binding it into a matrix is not decontamination.

You may decontaminate your own infectious waste and manage it as a normal solid waste without MPCA approval as long as the waste does not contain sharps.

If your waste contains sharps, you may only use an on-site decontamination system approved by the MPCA, and you must comply with the specified conditions of that approval. MPCA fact sheet #w-sw4-34, Infectious Waste – Approved waste management vendors and systems, at http://www.pca.state.mn.us/publications/w-sw4-34.pdf provides a list of approved decontamination systems.

For more information regarding on-site treatment, see MPCA fact sheet #w-sw4-33, Infectious Waste – Management guidance for on-site treatment, at http://www.pca.state.mn.us/publications/w-sw4-33.pdf.

2. Discharge liquid waste to a sanitary sewer or subsurface treatment system

You may discharge liquid infectious and dual waste to a public sanitary sewer system provided you both:

· Notify the operator of the receiving sanitary sewer system.

· Comply with any discharge limits or prohibitions set by the sanitary sewer system operator. You may discharge liquid infectious waste (but not dual waste) to a septic system provided you both:

· Notify the U.S. Environmental Protection Agency (EPA) you are operating a Class V injection well.

· Comply with all EPA discharge limits and prohibitions for a Class V injection well.

Do not discharge dual waste, hazardous waste, or unevaluated pharmaceuticals to a septic system.

3. Transport your own infectious waste to another allowed site You may transport your own infectious waste to either of the following:

· Another site you operate in order to consolidate or decontaminate the waste

· A certified infectious waste storage or decontamination facility

· (only) If your site is a partially exempt regulated infectious waste generator, to a licensed hospital. (See Specific generator requirements on page 5 for eligibility conditions for this option.) MPCA fact sheet #w-sw4-34, Infectious Waste – Approved waste management vendors and systems, at http://www.pca.state.mn.us/publications/w-sw4-34.pdf provides a list of certified infectious waste storage and decontamination facilities.

4. Ship or mail your infectious waste

If you ship or mail your infectious waste off site, ensure:

· You use only an infectious waste transporter registered with the MPCA

· Employees who prepare infectious waste for shipment have been trained under the HMR

· Your infectious waste is packaged and labeled in compliance with the HMR or U.S. Postal Regulations MPCA fact sheet #w-sw4-34, Infectious Waste – Approved waste management vendors and systems, at http://www.pca.state.mn.us/publications/w-sw4-34.pdf provides a list of registered infectious waste transporters.

Specific generator requirements

Hospitals

Hospitals must accept infectious waste, properly packaged to the hospital’s own standards, from:

· Licensed ambulance services

· Public school health services

· Eligible boards of health, community health boards, and public health nursing agencies Hospitals may also, but are not required to, accept:

· Properly packaged infectious waste from private school health services

· Properly labeled and packaged dual or hazardous waste from licensed ambulance services Hospitals voluntarily accepting the above two waste streams are not considered off-site commercial storage facilities and may manage such waste as their own; however, they must accept or reject these wastes from all similar entities equally. Hospitals may charge a reasonable fee for handling the wastes.

Licensed ambulance services

Ambulance services may dispose of their infectious and dual waste at the receiving hospital or transport the waste back to their operations base for consolidation and disposal.

Public and private school health services

Public and private preschool and K-12 school health services are exempt from regulation as infectious waste generators if they dispose of their properly packaged infectious waste at a hospital; however, they may be subject to the BBP.

Eligible boards of health, community health boards and public health agencies

These public entities are eligible for exemption from regulation as infectious waste generators if they are located in a county with a population less than 40,000 and they dispose of their properly packaged infectious waste at a hospital.

Home health care services

Residential health care services with six residents or less and all visiting in-home services may dispose of infectious and dual waste generated in the residence as exempt household waste at the residence with the approval of the resident. Alternatively, these services may transport the waste back to their operations base for consolidation and disposal. In both cases, home health care and residential services must prepare and maintain an infectious waste management plan.

See MPCA fact sheet #w-hhw4-67, Household Hazardous Waste: Safe Disposal Options for Needles and Syringes, at http://www.pca.state.mn.us/publications/w-hhw4-67.pdf for household sharps disposal guidance.

Household sharps collection

Any business or government agency site may collect household sharps for proper disposal without MPCA approval or being considered an off-site infectious waste storage facility. In addition, the MPCA will consider you exempt from any potential hazardous waste liability or requirements from pharmaceuticals or other wastes inadvertently collected with such sharps, provided you do all of the following:

· Do not accept sharps from businesses or government agencies

· Notify customers, such as by posting a sign at the collection site, that accepted containers must hold only household sharps and no waste pharmaceuticals

· Segregate collected household sharps from the site’s own waste until the wastes are shipped off site Note: Many counties now accept household waste pharmaceuticals for proper disposal through their sheriff’s department or designated drop-boxes. Contact your county environmental department for locations.

More information

Guidance and requirements in this fact sheet were compiled from Minnesota Statutes, Chapter § 116, and Minnesota Rules, Chapter 7035, and incorporate regulatory interpretation decisions made by the MPCA on May 21, 2010; September 20, 2010; April 15, 2011; May 3, 2011; March 8, 2012; February 5, 2015; and February 10, 2015. Visit the Office of the Revisor of Statutes at https://www.revisor.mn.gov/pubs to review statutes and rules.

Missouri Medical Waste Regulations

Who Regulates Infectious Waste?

The statutory and regulatory requirements governing infectious waste management and disposal in Missouri are found in the Missouri Solid Waste Management Law, located in the Missouri Revised Statues, sections 260.203 and 260.204, RSMo and the Missouri Solid Waste Management regulations, located in the Code of State Regulations, 10 CSR 80-7.010 and 10 CSR 80-5.010.

Infectious waste is regulated mainly by two state agencies, the Missouri Department of Health and Senior Services and the Missouri Department of Natural Resources.

The Missouri Department of Health and Senior Services regulates infectious waste management in hospitals, defines infectious wastes for those entities who generate small quantities of infectious waste and reviews infectious waste treatment methods for approval.

The Missouri Department of Natural Resources’ Waste Management Program regulates packaging, transporting, tracking, manifesting and disposing of infectious waste and issues permits for facilities to treat or process (consolidate or transfer) infectious waste. In general, once infectious waste leaves the generator, the Missouri Department of Natural Resources regulates the waste.

Packaging

For all those who generate infectious waste while doing business, untreated infectious waste must be properly packaged before being transported to any permitted treatment or disposal facility. Treated infectious waste does not have to meet the packaging requirements described below, except for the packaging requirements for sharps.

The waste must be placed in rigid or semi-rigid, leak-resistant containers, sealed and clearly marked with the universal biohazard symbol and labeled “Infectious Waste” or “Biohazard Waste”. Red plastic bags are often used for infectious waste packaging, but they cannot be used as the main (or only) container for this waste. All bags of infectious waste must be placed within rigid or semi-rigid containers before transport.

Sharps must be packaged in rigid, leak-resistant and puncture-resistant containers and sealed before transport.

All containers must be closed in such a way as to completely contain all waste and the outside of the container must be free of contamination. If containers will be reused to containerize infectious waste, the containers must be cleaned and sanitized in between each use.

Untreated infectious waste may not be disposed in any permitted landfill in Missouri, unless the waste was generated by an individual, properly packaged to prevent exposure to anyone who comes in contact with it, picked up by a waste hauler and transported to a sanitary landfill for disposal. All other infectious waste must be treated before disposal at a permitted sanitary landfill in Missouri or transported to a permitted infectious waste treatment or disposal facility. The specific regulatory requirements that govern packaging, transporting, treating, permitting and disposing are based on the infectious waste generator classification, and discussed in greater detail in the corresponding tabs above.

Small-quantity infectious waste generators are those entities that produce less than or equal to 100 kilograms (approximately 220 pounds) of infectious waste in one month. Examples of small-quantity infectious waste generators are doctor’s offices, dental offices, veterinarians’ offices, tattoo shops, health departments or agencies, schools, motels or hotels, home health agencies, nursing homes and research facilities.

The Missouri Solid Waste Management regulations allow four management options for small-quantity infectious waste generators:

Mail sharps to a permitted treatment facility using the U.S. Postal Service

Treat the infectious waste on-site before the waste is transported to a permitted disposal facility

Transport the infectious waste directly to a permitted facility for treatment

Hire a licensed infectious waste transporter to pick up and transport the waste to a permitted treatment or disposal facility

For more details about these options, review Infectious Waste Management by Small-Quantity Generators – PUB0188. There are other exemptions to regulatory requirements that may pertain to certain small-quantity infectious waste generators, such as pharmacies and home health agencies. For more information concerning these exemptions, review 10 CSR 80-7.010(1)(C).

Large-quantity infectious waste generators are those entities that produce more than 100 kilograms (approximately 220 pounds) of infectious waste in one month. These generators are likely large-scale medical facilities, such as hospitals, medical schools, large clinics, laboratories or medical research facilities.

The Missouri Solid Waste Management regulations allow two management options for large-quantity infectious waste generators:

Treat Infectious Waste On-Site

Hospitals and other large-quantity infectious waste generators may treat the infectious waste it generates on-site. Like small-quantity infectious waste generators, large-quantity infectious waste generators may treat waste on-site to render it innocuous (no longer infectious). However, because of the amount of waste produced by these generators, most do not choose this option. The treatment method a generator uses must consistently kill pathogens in the waste, the treatment equipment must be maintained to meet treatment standards and the generator must attest and sign treatment certificates guaranteeing treatment has indeed rendered the waste non-infectious.

If the generator treats the waste on-site, the large-quantity generator must meet all the requirements of the waste treatment certification process, which is described in Code of State Regulations 10 CSR 80-7.010(1)(B). After treatment, any treated sharps must be packaged in rigid, puncture-resistant containers before transporting, and all treated waste must be taken to either a permitted sanitary landfill or other disposal site.

The waste generator may transport the treated waste to a permitted waste disposal facility, using a secure delivery vehicle, or have its regular waste hauler transport the treated waste to the disposal facility. In either case, a treatment certificate, completed by the generator, must accompany the shipment and be provided to the waste hauler (if applicable) and the permitted sanitary landfill for their records.

Before the waste is transported to a permitted disposal facility, the waste generator should make contact with their waste hauler (if applicable) and the permitted sanitary landfill where the waste will be taken for disposal. The generator must determine what, if any, additional actions are needed before giving the treated waste to the hauler (if applicable) or transporting the waste themselves to the landfill. This will ensure the waste will be accepted by both the waste hauler (if applicable) and the landfill. The landfill may consider this waste a “special waste” and require certain forms be completed before accepting the treated waste. This documentation will be in addition to the infectious waste treatment certificate.

Hire a Licensed Infectious Waste Transporter

If a large-quantity infectious waste generator chooses not to treat the infectious waste it generates on-site at the business, the only other option available is to hire a licensed infectious waste transporter to pick up the waste and take it to a permitted infectious waste treatment or disposal facility. Although certain large-quantity generators, such as hospitals, are allowed to transport its infectious waste directly to a permitted infectious waste treatment or disposal facility, it must use its own staff and locked delivery vehicles to do so. Otherwise, hospitals, like other large-quantity generators, must hire a licensed infectious waste transporter.

Infectious waste generators must ensure untreated waste is properly packaged before transporting. Infectious waste transporter companies usually provide waste packaging and tracking documents, or manifests, to waste generators that meet the regulatory requirements. The manifests allow tracking of the waste during transport to a permitted infectious waste treatment or disposal facility. After treatment or disposal, the facility will return a copy of the completed manifest(s) or tracking document(s) to the large-quantity generators to prove the waste was treated and disposed of according to the regulatory requirements. These documents must be kept in the generators’ records to show proof of proper waste disposal.

For transportation options for small- or large-quantity infectious waste generators, please review the information provided on the corresponding generator tabs above. The information provided here pertains to large-quantity infectious waste generators that want to transport their own waste to a permitted infectious waste treatment or disposal facility, or other businesses who desire to operate an infectious waste transportation business. For regulatory requirements about infectious waste transportation, review Code of State Regulations 10 CSR 80-7.010(4). Requirements regarding manifesting or tracking documents during waste transport are provided in 10 CSR 80-7.010(3).

In Missouri, large-quantity infectious waste generators that want to transport their own waste and businesses who desire to haul infectious waste for small- and large-quantity infectious waste generators must first obtain a Hazardous Waste Transporter License from the Missouri Department of Transportation (MoDOT). This license allows the transporter to haul infectious waste from the point of generation to the permitted treatment facility. Companies may apply for a Hazardous Waste Transporter License online through MoDOT Carrier Express. The application provides an option to indicate that the transporter license is to haul infectious waste. For more information, visit MoDOT’s Hazardous Waste Transport webpage. You can also reach MoDOT by telephone at 573-751-7100 or toll-free at 866-831-6277.

Once MoDOT issues the license, the Missouri Department of Natural Resources is notified and adds the transporter’s name to the licensed infectious waste transporter list.

Mississippi Medical Waste Regulations

The Mississippi State Department of Health regulates the on-site storage and management of medical waste and infectious medical waste through the “Adopted Standards for the Regulation of Medical Waste in Health Care Facilities Licensed by the Mississippi State Department of Health”. For more specific information on these standards, contact the Health Facilities Licensure and Certification Division of that agency at (601) 576-7300. For information on the regulation of commercial management of medical wastes, contact the Solid Waste Management Branch at the MDEQ at (601) 961-5171.

 MEDICAL WASTE MANAGEMENT PLAN

All generators of infectious medical waste and medical waste shall have a medical waste management plan that shall include, but is not limited to, the following:

I. Storage and Containment of Infectious Medical Waste and Medical Waste

A. Containment of infectious medical waste and medical waste shall be in a manner and location which affords protection from animals, rain and wind, does not provide a breeding place or a food source for insects and rodents, and minimizes exposure to the public.

B. Infectious medical waste shall be segregated from other waste at the point of origin in the producing facility.

C. Unless approved by the Mississippi State Department of health or treated and rendered non-infectious. Infectious medical waste (except for sharps in approved containers) shall not be stored at a waste producing facility for more than seven days above a temperature of 6 C (38F). Containment of infectious medical waste at the producing facility is permitted at or below a temperature of O C (32F) for a period of not more than 90 days without specific approval of the Department of Health.

D. Containment of infectious medical waste shall be separate from other wastes. Enclosures or containers used for containment of infectious medical waste shall be so secured so as to discourage access by unauthorized persons and shall be marked with prominent warning sings on, or adjacent to, the exterior of entry doors, gates, or lids. Each container shall be prominently labeled with a sign using language to be determined by the Department and legible during daylight hours.

E. Infectious medical waste, except for sharps capable of puncturing or cutting, shall be contained in double disposable plastic bags or single bags (1.5 mills thick) which are impervious to moisture and have a strength sufficient to preclude ripping, tearing, or bursting under normal conditions of usage. The bags shall be securely tied so as to prevent leakage or expulsion of solid or liquid wasted during storage, handling, or transport.

F. All sharps shall be contained for disposal in leakproof, rigid, puncture-resistant containers which are taped closed or tightly lidded to preclude loss of the contents.

G. All bags used for containment and disposal of infectious medical waste shall be of a distinctive color or display the Universal Symbol for infectious waste. Rigid containers of all sharps waste shall be labeled.

H. Compactors or grinders shall not be used to process infectious medical waste unless the waste has been rendered non-infectious. Sharps containers shall not be subject to compaction by any compacting device except in the institution itself and shall not be placed for storage or transport in a portable or mobile trash compactor.

I. Infectious medical waste and medical waste contained in disposable containers as prescribed above, shall be placed for storage, handling, or transport in disposable or reusable pails, cartons, drums, or portable bins. The containment system shall be leakproof, have tight-fitting covers and be kept clean and in good repair.

J. Reusable containers for infectious medical waste and medical waste shall be thoroughly washed and decontaminated each time they are emptied by a method specified by the Mississippi State Department of Health, unless the surfaces of the containers have been protected from contamination by disposable liners, bags, or other devices removed with the waste, as outlined in I.E.

Approved methods of decontamination include, but are not limited to, agitation to remove visible soil combined with one or more of the following procedures:

1. Exposure to hot water at least 180 F for a minimum of 15 seconds.

2. Exposure to a chemical sanitizer by rinsing with or immersion in one of the following for a minimum of 3 minutes:

a. Hypochlorite solution (500 ppm available chlorine).

b. Phenolic solution (500 ppm active agent).

c. Iodoform solution (100 ppm available iodine).

d. Quaternary ammonium solution (400 ppm active agent).

Reusable pails, drums, or bins used for containment of infectious waste shall not be used for containment of waste to be disposed of as noninfectious waste or for other purposes except after being decontaminated by procedures as described in part (J) of this section.

K. Trash chutes shall not be used to transfer infectious medical waste.

L. Once treated and rendered non-infectious, previously defined infectious medical waste will be classified as medical waste and may be landfilled in an approved landfill.

II. Treatment or disposal of infectious medical waste shall be by one of the following methods:

A. By incineration in an approved incinerator which provides combustion of the waste to carbonized or mineralized ash.

B. By sterilization by heating in a steam sterilizer, so as to render the waste noninfectious. Infectious medical waste so rendered non-infectious shall be disposable as medical waste. Operating procedures for steam sterilizers shall include, but not be limited to, the following:

1. Adoption of standard written operating procedures for each steam sterilizer including time, temperature, pressure, type of waste, type of container(s), closure on container(s), pattern of loading, water content, and maximum load quantity.

2. Check or recording and/or indicating thermometers during each complete cycle to ensure the attainment of a temperature of 121 C (250 F) for onehalf hour or longer, depending on quantity and density of the load, in order to achieve sterilization of the entire load. Thermometers shall be checked for calibration at least annually.

3. Use of heat sensitive tape or other device for each container that is processed to indicate the attainment of adequate sterilization conditions.

4. Use of the biological indicator Bacillus stearothermophilus placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

5. Maintenance of records of procedures specified in (1), (2), (3) and (4) above for period of not less than a year.

6. By discharge to the approved sewerage system if the waste is liquid or semi-liquid, except as prohibited by the State Department of Health.

C. Recognizable human anatomical remains shall be disposed of by incineration or internment, unless burial at an approved landfill is specifically authorized by the Mississippi State Department of Health.

D. Chemical sterilization shall use only those chemical sterilants recognized by the U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances. Ethylene oxide, glutaraldehyde, and hydrogen peroxide are examples of sterilants that, used in accordance with manufacturer recommendation, will render infectious waste non-infectious. Testing with Bacillus subtilis spores or other equivalent organisms shall be conducted quarterly to ensure the sterilization effectiveness of gas or steam treatment.

III. Treatment and disposal of medical waste which is not infectious shall be by one of the following methods:

A. By incineration in an approved incinerator which provides combustion of the waste to carbonized or mineralized ash.

B. By sanitary landfill, in an approved landfill which shall mean a disposal facility or part of a facility where medical waste is placed in or on land, and which is not a treatment facility.

All the requirements of these standards shall apply, without regard to the quantity of medical waste generated per month, to any generator of medical waste to include, but not be limited to, the following categories:

Hospitals

Nursing Facilities

Ambulatory Surgical Facilities

Home Health Agencies

Birthing Centers

TRANSPORTATION, MANAGEMENT AND DISPOSAL ISSUES

The off-site management and disposal of infectious medical waste is regulated by the MDEQ under the provisions of the Mississippi Nonhazardous Solid Waste Management Regulations and the Mississippi Solid Waste Law. Disposal of such waste at a landfill or other solid waste facility is addressed through specific conditions in that facility’s solid waste management permit. These permit conditions generally prohibit municipal solid waste disposal facilities from accepting infectious medical waste that has not been rendered non-infectious. State regulations also require that, prior to the establishment of any commercial facility in the State specifically for the storage, transfer, treatment, or processing of infectious medical wastes, the owner or operator of the facility must obtain environmental operating permits from the MDEQ for a solid waste management facility.

Medical waste transporters are not currently required by the MDEQ to obtain any special licensing or permits. However, state solid waste laws stipulate that, upon collection of the wastes, the person or company collecting and transporting the wastes assumes ownership once transfer of the waste material has occurred. The transporter is then required by State regulations to manage the wastes in a manner that is protective of public health and the environment. The transporter must also deliver the wastes to a facility that is properly permitted to accept and manage such wastes. This does not, however, alleviate the generator’s responsibility to acquire the services of a legitimate medical waste collection company and to confirm that the company is handling and disposing of the generator’s wastes properly. Current regulations do not require that the removal and transportation of medical wastes be manifested by the collector. However, the MDEQ recommends that generators of medical wastes require that persons or companies collecting such wastes from the generator supply the generator with certified manifest forms documenting proper management and disposal of the waste. Copies of these documents should be kept on file by the generator, the collector, and the receiving facility.

Be advised that other State and/or Federal agencies including, but not limited to, the Mississippi Public Service Commission and the U. S. Department of Transportation (Office of Motor Carriers) may have specific requirements regarding the collection and transportation of infectious medical waste and/or medical waste.

Montana Medical Waste Regulations

Management Standards — Procedures for Storage, Transportation, Treatment, And Disposal

75-10-1005. Management standards — procedures for storage, transportation, treatment, and disposal. (1) Infectious waste must be separated from ordinary waste at the point of origin and stored until the waste is rendered noninfectious in separate, distinct containers with biohazard warning labels in compliance with the following procedures:

(a) Sharps must be contained for storage, transportation, treatment, and subsequent disposal in leakproof, rigid, puncture-resistant containers that must be taped closed or capped securely to prevent loss of contents.

(b) Infectious waste other than sharps must be contained in moisture-proof disposable containers or bags of a strength sufficient to prevent ripping, tearing, or bursting under normal conditions of use. The bags must be securely tied to prevent leakage or expulsion of solid or liquid wastes during storage, handling, and transportation.

(2) To inhibit the spread of infectious agents, infectious waste must be stored prior to treatment in a secured area that prevents access by unauthorized personnel and must be clearly marked or labeled as infectious.

(3) Handling of infectious waste must be done in a manner to prevent compaction or other mechanical manipulation that might cause the release of infectious agents.

(4) (a) Treatment and disposal of infectious waste must be accomplished through the following methods:

(i) incineration with complete combustion that reduces infectious waste to carbonized or mineralized ash;

(ii) steam sterilization that renders infectious waste noninfectious; or

(iii) sterilization by standard chemical techniques or by any scientifically proven techniques approved by state and federal authorities.

(b) Liquid or semisolid infectious waste may be discharged into a sewer system that provides secondary treatment or into a primary treatment sewage system if waste is first sterilized by chemical treatment. A subsurface disposal system installed and operated in accordance with state or local sanitary regulations is, for the purpose of this subsection (b), a sewer system providing secondary treatment.

(c) Fetal remains or recognizable body parts other than teeth must be disposed of by incineration or interment.

(5) If infectious waste has been rendered noninfectious by one of the methods listed in subsection (4) and is no longer biologically hazardous, it may be mixed with and disposed of with ordinary waste in the following manner:

(a) Steam-sterilized waste must be labeled identifying it as such with heat sensitive tape or bagged in marked autoclavable bags.

(b) Chemically treated waste or waste otherwise treated under subsection (4)(a)(iii) must be appropriately labeled.

(6) Infectious waste may be transported by the generator, a municipal solid waste service, or a regulated commercial hauler to an offsite treatment facility if the waste is confined in a leakproof, noncompacting, fully enclosed vehicle compartment.

(7) (a) Infectious waste that has been treated by one of the methods in subsection (4) may be disposed of in a properly operated landfill licensed under 75-10-221.

(b) Untreated infectious waste may be disposed of at a licensed, properly operated landfill until April 1, 1993, if it is buried in a separate area without compaction and with minimum disturbance.

(8) An employee who handles or manages infectious waste must receive training provided by the employer that is adequate to ensure safe performance of duties.

(9) Generators and transporters of infectious waste shall develop a contingency plan to handle spills and equipment failure.

North Carolina Medical Waste Regulations

Storage of Regulated Medical Waste to be Treated Off-Site

A medical waste generator that stores regulated medical waste and will have regulated medical waste treated off-site shall comply with 15A NCAC 13B .1202 and 15A NCAC 13B .1203.

Storage of Medical Waste not Classified as Regulated Medical Waste

A medical waste generator that stores medical waste and will have medical waste disposed of off-site or treated off-site shall comply with 15A NCAC 13B .1202.

Packaging Requirements for Regulated Medical Waste Treated Off-Site

Regulated medical waste is required to be packaged per 15A NCAC 13B .1203.

Packaging Requirements for Regulated Medical Waste Treated On-Site

The packaging requirements stated in 15A NCAC 13B .1203 only apply to regulated medical waste treated off-site. There are no packaging requirements for regulated medical waste treated onsite at the generating facility.

Required Information Provided to the Division for Transfer or Storage Operations Occurring at a Location other than a Treatment Facility

The responsible party for regulated medical waste transfer or storage operations occurring at a location other than a permitted treatment facility shall comply with 15A NCAC 13B .1203(d)(2).

Regulated Medical Waste Records Requirements

The medical waste management rules require that regulated medical waste generators and treatment facilities maintain records per 15A NCAC 13B .1203(b) and 15A NCAC 13B .1204(b).  

Required Information Provided to the Division for Transfer or Storage Operations Occurring at a Location other than a Treatment Facility

The responsible party for regulated medical waste transfer or storage operations occurring at a location other than a permitted treatment facility shall comply with 15A NCAC 13B .1203(d)(2).

Generators Responsible for the Proper Disposal of Medical Waste

Generators are responsible to ensure that medical waste is disposed of properly. Medical waste, not classified as regulated medical waste, may be disposed of at a municipal solid waste landfill. Regulated medical waste is required to be treated at a permitted treatment facility. 15A NCAC 13B .0202(i) states the medical waste treatment and disposal methods.   

Generators Responsible for Packaging Regulated Medical Waste by Treatment Method Type

A generator is responsible for packaging regulated medical waste per the treatment method type to be used. A generator shall comply with 15A NCAC 13B .1203(b)(1).

Transport of Regulated Medical Waste

Transporters of regulated medical waste shall comply with 15A NCAC 13B .1203. The Medical Waste Management rules do not require that transporters of regulated medical waste register with the Division however, there may be applicable North Carolina Department of Transportation regulations.

Treatment Facilities for Regulated Medical Waste

Regulated medical waste may be treated at the generating facility per 15A NCAC 13B .1201(2) and 15A NCAC 13B .1202(j).  If regulated medical waste is not treated at the generating facility, it must be treated at a permitted treatment facility per 15A NCAC 13B .1204.

Permitting of Medical Waste Treatment Facilities

The Division does not issue permits for medical waste treated at the generating facility.  Permits are required for treatment facilities receiving medical waste generated off-site.

Treatment of Large Volumes of Blood and Body Fluids

Incineration or sanitary sewage are acceptable treatment methods for blood and body fluids in individual containers in volumes greater than 20 ml.

Disposal of Dialysates, Feces, and Urine

The term blood and body fluids does not include dialysates, feces, or urine if not removed during surgeries and autopsies.  Dialysates, feces and urine that are not designated as blood and body fluids are not regulated medical waste. 

Disposal of Bloody Gauze, Used Gloves, Tubing, Dressings, etc.

Disposal of medical waste such as bloody gauze, used gloves, tubing, and dressings are not regulated medical waste. Medical waste that is not regulated medical waste may be disposed of in a municipal solid waste landfill.

The “50 Pound per Month” Record-Keeping Exemption

15A NCAC 13B .1203(b) exempts generators from maintaining records if they generate less than 50 pounds of regulated medical waste per month.

Municipal Solid Waste Landfill Rejection of Properly Packaged Sharps or Treated Regulated Medical Waste

Municipal solid waste landfills may reject any solid waste for disposal in the landfill, even though State regulations allow for its disposal.

Managing Medical Waste After It Has Been Treated

Treated regulated medical waste is subject to 15A NCAC 13B .1204(a).

Human Remains Intended for Interment or Disposal

The medical waste management rules do not pertain to caskets or the like containing human remains intended for interment or cremation.

Interment of a Body with Its Removed Organs, Sharps, Tubing, etc. Due to Religious Practices

The medical waste management rules are not intended to interfere with the religious preferences of an individual.

Sharps Used During Preparation of a Body

Sharps used during the preparation of a body for interment or cremation are medical waste and subject to 15A NCAC 13B .1202(b).

Crematorium Use for the Incineration of Regulated Medical Waste

Crematoriums do not meet the requirements of a regulated medical waste incinerator and shall not be used for the treatment of medical waste.

Funeral Home Waste and Regulated Medical Waste Treatment Facilities

With the exception of blood and body fluids, which can be disposed of by sanitary sewer as a form of treatment, most funeral homes do not generate regulated medical waste for disposal. Only regulated medical waste requires treatment prior to disposal. Non-regulated medical waste does not require treatment prior to disposal.

North Dakota Medical Waste Regulations

Management standards.

In addition to sections 33-20-01.1-04, 33-20-01.1-05, 33-20-02.1-01, and 33-20-04.1-08, every person who collects, stores, transports, treats, or disposes of regulated infectious waste shall comply with these standards of performance.

1. At the point of origin, regulated infectious waste must be separated from other wastes and placed in distinctive containers which do not leak and which are impervious, puncture resistant, and tear resistant and which contain obvious markings (for example, red or orange plastic bags or the biohazard label). Bags and containers holding regulated infectious waste must be tied, closed, or sealed securely to prevent leakage.

2. At the point of origin, sharps must be:

a. Separated from other regulated infectious waste, disinfected onsite, rendered nonsharp onsite, and then disposed; or

b. Placed in rigid and puncture-resistant biohazard containers and handled as required by subsection 5.

3. The handling and storage of regulated infectious waste, before the treatment of subsection 5, must be conducted in a manner which minimizes exposure to employees of the waste generator, the waste transporter, and the public.

4. Recycled containers or devices such as carts used for the handling of wastes must be disinfected after each use.

5. All regulated infectious waste must be incinerated or disinfected and sharps that are not incinerated must be rendered nonsharp before disposal. Incineration and disinfection equipment and facilities shall meet the requirements of article 33-15 and this article.

6. Blood and blood products can be discarded without incineration or disinfection through municipal sewage disposal systems that meet the requirements of article 33-16.

7. The disposal of nonviable human fetuses shall meet the requirements of section 33-03-02-05.

8. An infectious waste which is not regulated by this chapter may be disposed at a permitted municipal waste landfill.

9. Household waste containing regulated infectious waste in amounts normally found in household waste may be disposed of at a permitted municipal waste landfill.

Nebraska Medical Waste Regulations

Special Wastes

No person shall dispose of a special waste at any place except a permitted solid waste disposal area which is operated and maintained in compliance with Department regulations and authorizations, unless the Department grants prior written approval for an alternate location and management method.

Classification. Wastes shall be classified as special wastes by the Department on a case-by-case basis. The Department shall make a determination based upon the characteristics and properties of the solid waste. The Department’s determination shall be based upon the following information:

01 A general description of the waste;

02 The source of the waste, including the name and address of the generator;

03 A description of the industrial process which results in the waste, if applicable;

04 The quantity of the waste to be disposed (volume and/or weight);

05 A detailed description or analyses of the physical properties of the waste including, but not limited to size, density, and percent solids, if applicable;

06 A detailed description or analyses of the chemical properties of the waste including, but not limited to, pH, reactivity, leachability and total metals, if applicable;

07 A description or analyses of the biological properties of the waste, if applicable, including but not limited to, pathogens;

08 The liquid content, if any, of the waste;

09 A description of the method and location of the proposed disposal; and

10 Any other information about the waste as required by the Department in order to make a determination.

Alternate management methods.

The Department shall grant prior written approval for alternate locations and management methods for special wastes based on an evaluation of the characteristics and properties of the waste and the suitability of the location and management method proposed. This evaluation will be based on, but not limited to, the following criteria:

01 Distance from inhabited residences, businesses, or facilities/lands frequented by the public;

02 Distance from drinking water wells (municipal, domestic, etc.);

03 Distance from any surface water features (ponds, lakes, streams, etc.);

04 Location within a 100-year flood plain or within areas designated as wetlands;

05 Location within a designated wellhead protection area, or other Title 118 – Ground Water Quality Standards and Use Classification Class GA areas;

06 Soil type, permeability and slope of land;

07 Depth to ground water; and

08 Any other information about the location or management method as required by the Department.

Infectious wastes. Infectious wastes shall not be disposed of at any solid waste disposal area unless such wastes are first rendered non-infectious by incineration, autoclaving, or other treatment method. This provision does not apply to infectious waste from households.

Delisted wastes. The Director may require the disposal of delisted wastes in a delisted waste disposal area as deemed necessary to protect human health and the environment.

New Hampshire Medical Waste Regulations

INFECTIOUS WASTE

 Env-Sw 904.01 Applicability. (a) The rules in this part shall apply to management of infectious waste and treated infectious waste which is not ash residue, from the point of origin to the point of final disposal, including the following:

(1) Cultures and stocks of infectious agents and associated biologicals, including:

a. Cultures and stocks of infectious agents from research and industrial laboratories;

b. Wastes from the production of biologicals, discarded live and attenuated vaccines; and

c. Culture dishes and devices used to transfer, inoculate and mix cultures;

(2) Pathological wastes, including tissues, organs, and body parts that were removed during surgery or autopsy;

(3) Waste human blood and products of blood, including:

a. Serum, plasma and other blood components;

b. Containers contaminated with a. above which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals; and

c. Items saturated or dripping with human blood or items that were saturated or dripping with human blood that are now caked with dried human blood or blood components;

(4) Sharps that have been used in human or animal patient care or in medical, research, or industrial laboratories, including hypodermic needles, syringes, pasteur pipettes, broken glass and scalpel blades;

(5) Contaminated animal carcasses, body parts, and bedding of animals that were exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals;

(6) Wastes from human or animal patient care, surgery or autopsy that were in contact with infectious agents, including soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves;

(7) Laboratory wastes from medical, pathological, pharmaceutical, or other research, commercial or industrial laboratories that were in contact with infectious agents, including slides and cover slips, disposable gloves, laboratory coats, and aprons;

(8) Dialysis wastes that were in contact with the blood of patients undergoing hemodialysis, including contaminated disposable equipment and supplies such as tubing, filters, disposable sheets, towels, gloves, aprons, and laboratory coats;

(9) Discarded medical equipment and parts that were in contact with infectious agents;

(10) Biological waste and discarded materials contaminated with blood, excretion, exudates or secretion from humans or animals who are isolated to protect others from communicable diseases;

(11) Any discarded preparations made from genetically altered living organisms and their products; and

(12) Such other waste material that results from the administration of medical care to a patient whether human or animal by a health care provider and is found by the director in consultation with the division of public health services or state veterinarian to pose a threat to human health or the environment due to its infectious nature.

 (b) The rules in this part shall not apply to the following types of waste:

(1) Gloves, gowns, underpads or any other materials that come in contact with patients, but not saturated with blood, body fluids or secretions, through routine examination or patient care;

(2) Animal carcasses not included in (a)(5) above; and

(3) Household infectious waste, provided that:

a. Sharps shall be enclosed inside rigid, puncture-resistant containers;

b. Containers encasing sharps shall be sealed and labeled “not for recycling”; and

c. The waste shall be disposed at an authorized facility only.

Source. #5172, eff 7-1-91; ss by #6535, INTERIM, eff 7-1-97, EXPIRES: 10-29-97; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.01); ss by #10598, eff 7-1-14

 Env-Sw 904.02 Collection, Storage and Transfer Requirements.

 (a) Collection, storage and transfer of infectious waste shall comply with Env-Sw 400 and this section.

 (b) The waste shall be stored in a pre-designated location, protected from water, rain and wind.

 (c) Storage containers and packaging shall be labeled conspicuously in a legible manner with the words “infectious waste,” or “biohazard waste,” or with the universal biohazard symbol.

 (d) Waste stored at generator facilities shall be maintained in a nonputrescent state, using refrigeration when necessary.

 (e) Waste shall not be stored at room temperatures in excess of 72 hours.

 (f) Outdoor storage areas containing the waste, such as dumpsters, sheds, tractor trailers, or other storage areas, shall be locked to prevent unauthorized access.

 (g) Access to on-site storage areas shall be limited to authorized persons.

 (h) The waste shall be stored in a manner that shall provide protection from animals and shall not provide a breeding place or a food source for insects or rodents.

 (i) Storage containers and packaging shall be of sufficient structural integrity to ensure that the waste shall not be released to the environment during storage.

 (j) The contents of damaged or ruptured containers shall be re-packaged.

 (k) Infectious waste shall be transferred by the generator to authorized facilities only.

 (l) Facilities which receive infectious waste from off-site generators shall not store the waste in excess of 7 days from date of receipt.

Source. #5172, eff 7-1-91; amd by #5297, eff 12-24-91; ss by #6535, INTERIM, eff 7-1-97, EXPIRES: 10-29-97; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly EnvWm 2604.02); ss by #10598, eff 7-1-14

 Env-Sw 904.03 Processing and Treatment Requirements.

 (a) Except as noted in Env-Sw 904.08, the generator of infectious waste shall assure that the waste is treated at an authorized facility to achieve high-level disinfection plus a 4 log 10 reduction of Bacillus subtilis or Bacillus stearothermophilus.

 (b) Facilities that process or treat infectious waste in New Hampshire, including generator facilities, shall meet (a), above, in conformance with Env-Sw 500 and the following:

(1) All infectious waste managed by the facility shall be collected and stored as specified in EnvSw 904.02, pending treatment in accordance with (a) above;

(2) If the facility processes or treats infectious waste by methods other than incineration, the efficacy of the processing or treatment method shall be demonstrated by testing as specified in Env-Sw 904.07; and

(3) If the facility is an incinerator that treats the infectious waste by combustion, the facility shall meet Env-Sw 700.

 (c) Infectious waste treated under (a) above shall not be combined or mixed with other waste prior to disposal, unless authorized by the receiving disposal facility.

Source. #5172, eff 7-1-91; amd by #5297, eff 12-24-91; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly EnvWm 2604.03); ss by #10598, eff 7-1-14

 Env-Sw 904.04 Disposal Requirements.

 (a) Infectious waste shall not be landfilled in New Hampshire unless treated to achieve the standard specified in Env-Sw 904.03(a).

 (b) Treated infectious waste shall be disposed at authorized facilities only.

 (c) Notification shall be given by the transporter to the receiving facility prior to the disposal of treated infectious waste.

 (d) Liquid infectious waste may be disposed via a sanitary sewer, subject to the provisions of local sewer ordinances and regulations, only if the receiving wastewater treatment facility includes secondary treatment.

Source. #5172, eff 7-1-91; ss by #6535, INTERIM, eff 7-1-97, EXPIRES: 10-29-97; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.04); ss by #10598, eff 7-1-14

 Env-Sw 904.05 Reuse Requirements and Limitations.

 (a) Infectious waste shall not be reused or certified for distribution and use pursuant to Env-Sw 1500, except as provided in (b) below.

 (b) Materials or equipment contaminated with infectious waste, for example surgical equipment, maintenance carts, bedding, waste containers and the like, may be salvaged and reused in-kind pursuant to Env-Sw 1503.04, subject to the following requirements:

(1) If reused within the generating facility, the materials and equipment shall be cleaned and disinfected prior to reuse to achieve the standards for disinfection prescribed by the facility’s internal management protocol; and

(2) If sent off-site for reuse, the materials and equipment shall be cleaned and disinfected prior to leaving the generating facility to achieve at least the level of treatment specified in Env-Sw 904.03(a).

Source. #5172, eff 7-1-91; ss by #6535, INTERIM, eff 7-1- 97, EXPIRES: 10-29-97; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.05); ss by #10598, eff 7-1-14

 Env-Sw 904.06 Transportation, Packaging and Labeling Requirements.

 (a) Infectious waste transported off-site for treatment prior to disposal shall be transported in conformance with the United States Department of Transportation hazardous materials regulations as provided in 49 CFR 171-180 or as specified in (b) below.

 (b) The transportation of infectious waste not subject to 49 CFR 171-180 shall be subject to the following:

(1) Sharps as described in Env-Sw 904.01(a)(4) shall be segregated and encased inside rigid, puncture-resistant containers;

(2) Infectious waste and sharps containers shall be placed in a sealed nonpermeable 3 mil polyethylene bag or equivalent, which is itself placed in a second bag of similar construction and sealed; and

(3) The outermost container or package shall be labeled with the following:

a. Clear markings indicating the contents which shall include the words “Infectious waste,” or “Biohazard waste” or the universal biohazard symbol; and

b. The name, address and telephone number of the generator and transporter.

 (c) Transporters shall notify the receiving facility prior to delivering infectious waste to a New Hampshire landfill.

Source. #5172, eff 7-1-91; ss by #6535, INTERIM, eff 7-1-97, EXPIRES: 10-29-97; ss by #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.06); ss by #10598, eff 7-1-14

 Env-Sw 904.07 Testing and Reporting Requirements.

Facilities, including generator facilities, which treat infectious waste by methods other than incineration shall be subject to the following:

 (a) QA/QC efficacy testing shall be performed during initial facility operations to verify facility operating procedures meet Env-Sw 904.03(a);

 (b) Following verification as specified in (a) above, the facility shall perform QA/QC efficacy testing no less than 4 times yearly, to demonstrate compliance with Env-Sw 904.03(a); and

 (c) The facility shall maintain the records of QA/QC efficacy testing for a minimum of 3 years.

Source. #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.07); ss by #10598, eff 7-1-14 Env-Sw 904.08 Other Requirements. Limbs and recognizable organs, excluding teeth and contiguous gum tissue, shall be disposed by incineration or interment. Source. #6619-B, eff 10-29-97; (See Revision Note at chapter heading for Env-Sw 900); ss by #8459, eff 10-28-05 (formerly Env-Wm 2604.08); ss by #10598, eff 7-1-14

New Jersey Medical Waste Regulations

GENERATORS OF REGULATED MEDICAL WASTE

“Generator” means any person, by site, whose act or process produced RMW as defined in N.J.A.C. 7:26-3A.6 or whose act first causes a RMW to become subject to regulation. Noncontiguous properties owned or operated by the same person are separate sites and in the case where more than one person (for example, doctors with separate medical practices) are located in the same building and office, each individual business entity is a separate generator for the purposes of this subchapter. However, household utilizing home self-care exclusively are not generators.

The New Jersey medical waste regulations require all medical waste generators, transporters, intermediate handlers and destination facilities to track RMW, no matter how small the amount generated. Each generator shipping RMW off site is responsible for initiating the New Jersey RMW Tracking Form. Each person in the chain of custody (handling process) of RMW assumes the responsibility for getting the waste to the proper destination facility for treatment, destruction, or disposal.

Portions of the New Jersey RMW Tracking Form must be completed by the RMW generators, transporters, intermediate handlers, and by the destination or disposal facilities. (N.J.A.C. 7:26-3A.19, 3A.31, 3A.39, and 3A.41)

In additional, RMW generated in New Jersey but transported for disposal in another state, which prints and requires use of its own tracking form, must also be report on that state’s tracking form. (N.J.A.C. 7:26-3A.19(a))

 GENERATOR REQUIREMENTS

Assistance with waste classification can be obtained from NJDEP’s Bureau of Landfill and Hazardous Waste Permitting at (609) 984-6985 or the Department of Health’s Division of Environmental and Occupational Health Services at (609) 826-4941.

All medical waste generators, no matter how small the amount produced, with the exception of home self-care medical waste, must register with the NJDEP and pay the appropriate fees (N.J.A.C. 7:26-3A.8(a)). For information on medical waste generator registration, please call (609) 984-3448.

Generators must segregate RMW intended for transport off site, o the extent practicable, prior to placement in containers. *Generators must segregate RMW into:

1. Sharps (Classes 4 and 7 as defined at N.J.A.C. 7:26-3A.6(a)) including sharps containing residual fluids;

2. Fluids (quantities greater than 20 cubic centimeters); and

3. Other RMW.

*If waste other than RMW is placed in the same container(s) as RMW then the generator must package, label, and mark the container and its entire contents according to the RMW rule requirements at N.J.A.C. 7:26-3A.11, 3A.14, and 3A.15.

Any person who stores RMW prior to treatment or disposal on-site or for transport off site must:

1. Store the RMW in a manner and location that maintains the integrity of the packaging and provides protection from the elements;

2. Maintain the RMW in a nonputrescent state using refrigeration if necessary;

3. Lock any outdoor storage areas containing RMW to prevent unauthorized access;

4. Limit access to on site storage areas only to authorized employees;

5 Store the RMW in a manner that provides protection from animals and does not provide a breeding place or a food source for insects and rodents;

6. Disposal of RMW immediately if it becomes putrescent; and

7. Store RMW for no longer than one year.

Generators must ensure that all RMW is placed in containers* that are:

1. Rigid;

2. Leak-resistant;

3. Impervious to moisture;

4. Sufficiently strong to prevent tearing or bursting under normal conditions of use and handling;

5. Sealed to prevent leakage during transport;

6. Puncture resistant for packaging sharps and sharps with residual fluids; and

7. Break-resistant and tightly lidded or stoppered for packaging fluids (quantities greater than 20 cubic centimeters).

8. Solid waste that is not managed as RMW shall not be packaged for shipment inside a RMW container or in containers attached to, or part of an RMW container.

Generators must use only medical waste transporters, who are registered with Solid Waste Compliance and Enforcement and who possess a Certificate of Public Convenience and Necessity (N.J.A.C. 7:26-3A.27) from the NJDEP. Contact Solid Waste Compliance and Enforcement at (609) 292-7081. (N.J.A.C. 7:26-3A.16(d))*

*Exemption: N.J.A.C. 7:26-3A.17(a): Generators of less than 3 cubic feet (50 ponds) of RMW per month who transport only their own RMW to another generator for storage or disposal are exempt from transporter registration requirements provided:

(1) the RMW is transported by the generator or authorized employee in a vehicle with a gross weight of less than 8,000 pounds, owned by the generator or authorized employee;

(2) the original generation point and the storage point or disposal facility are located in New Jersey; and

(3) the generator completes a New Jersey Tracking Form in accordance with (N.J.A.C. 7:26-3A.19(e)).

*Exemption: N.J.A.C. 7:26-3A.17(b): Generators who transport Class 4 and Class 7 RMW (sharps and unused sharps) through US Postal Service do not need to use a registered medical waste transporter if:

1. the generator generates less than three cubic feet (5) pounds) RMW per month and ships less than 3 cubic feet (50 pounds) of RMW per shipment,

2. the package is sent registered or certified mail, return receipt requested (indicating the person to which the package is sent, signature of sender, date, and address where delivered) or Priority Mail;

3. the generator shall retain the original mailing receipt and returned registered or certified mail receipt, or in case of Priority Mail, a hard copy of the electronic delivery confirmation (containing at least the name, address, city, state, and zip code of the facility, date of delivery and amount of RMW delivered) attached to the generator copy of the tracking form; and

4. the generator shall comply with tracking form requirements at N.J.A.C. 7:26-3A.19.

Transporters may not accept any shipment of RMW from a generator unless the outer surface of the container is properly labeled and marked in accordance with N.J.A.C. 7:26-3A-14 and 3A.15 (N.J.A.C. 7:26-3A.28(a))

Labeling refers to the destination of the contents as “medical waste” or “infectious waste”.

Labeling means each generator must, prior to offering for transport off site, label each container of untreated RMW with a water-resistant label affixed to or printed on the outside of the container. The label shall include the words “Medical Waste”, or “Infectious Waste”, or display the universal biohazard symbol. Containers of treated medical waste or red plastic bags used as inner packaging are not required to be labeled (N.J.A.C. 7:26-3A.14(a)1).

Marking refers to the use of a name and address. Treated RMW is required to be marked (N.J.A.C. 7:26-3A(a)2). Marking means the generator, including an intermediate handler must mark the outermost surface of the outer container of RMW prepared for shipment with a waterresistant identification tag containing the generator’s or intermediate handler’s name and address, the transporter’s name and NJDEP solid waste registration number, date of shipment, and identification of the contents as RMW (N.J.A.C. 7:26-3A.15(a)1).

Each New Jersey RMW Tracking Form contains 6 copies to be distributed as follows: (N.J.A.C. 7:26-3A.19)

Copy 6 Generator copy – retained by generator

Copy 3, 4 & 5 Transporter copy – retain by transporter

Copy 2 Destination Facility Copy – retained by destination facility owner/operator

Copy 1 Generator copy – mailed to generator by destination facility

a. The generator completes items 1 through 15, including signing the certification at item 15; TRANSPORTATION OF RMW USING A MEDICAL WASTE TRANSPORTER LABELING AND MARKING TRACKING FORM RMW Generator Fact Sheet (rev. Nov 2013) Page 6 of 7

b. The transporter verified the quantity, notes any discrepancies in item 23, and completes and signs item 16;

c. The generator removed copy 6 and keeps it; and

d. The transporter retains copies 3, 4, 5 and delivers the waste to the approved destination facility.

Generators must complete the generator portion of the tracking form and sign the certification. A licensed medical waste transporter may complete the generator section of the tracking form, but it is the generator who is ultimately responsible for ensuring the information is accurate. All RMW that is shipped off the site of generation must be accompanied by a properly completed tracking form. Certification should be completed at the time that the RMW is picked up by the licensed transporter (N.J.A.C.7:26-3A.19). Retain a copy of each tracking form for at least three years from the date the waste was accepted by the initial transporter unless the Department specifically requires an additional retention period (N.J.A.C. 7:26-3A.21(a)1).

If a copy of the completed tracking form is not received from the destination facility within 35 days of acceptance of waste by the initial transporter, the generator must contact the transporter or facility to determine the status of the tracked waste (N.J.A.C. 7:26-3A.22(a)). If a signed copy of the tracking form is not received from the destination facility within 45 days of acceptance of the waste by the transporter, the generator must submit a Generator Exception Report ( N.J.A.C. 7:26-3A.22(b)) to:

New Jersey Department of Environmental Protection

Bureau of Solid Waste Compliance & Enforcement

Mail Code 09-01

P.O. Box 420

Trenton, NJ 08625-0420

The Exception Report must be postmarked on or before the 46th day and include:

1. A legible copy of the original tracking form for which the generator does not have confirmation; and

2. A cover letter signed by the generator explaining the efforts taken and the results to locate the RMW.

A copy of the Exception Report must be kept for at least 3 years from the date of the report. Generators of more than 200 pounds of RMW during the period of June 22 (previous year) through June 21(current year) must complete and submit an Annual Generator Report (forms are provided by the NJDEP) to the Department by July 21st of each calendar year unless the Department specifically changes the reporting or filing date (N.J.A.C. 7:26- 3A.21(d)).

New Mexico Medical Waste Regulations

INFECTIOUS WASTE

A. This section applies:

(1) without regard to the quantity of infectious waste generated, to any generator of infectious waste including, but not limited to:

(a) general acute care hospitals;

(b) skilled nursing facility or convalescent hospitals;

(c) intermediate care facilities;

(d) in-patient care facilities for the developmentally disabled;

(e) dialysis clinics;

(f) free clinics;

(g) community clinics;

(h) employee clinics;

(i) health maintenance organizations;

(j) home health agencies;

(k) surgical clinics;

(l) urgent care clinics;

(m) acute psychiatric hospitals;

(n) blood/plasma centers;

(o) laboratories;

(p) medical buildings;

(q) physicians offices;

(r) veterinarians;

(s) dental offices;

(t) acupuncturists;

(u) funeral homes;

(v) eye clinics; and

(w) tattoo parlors and body-piercing establishments; and

(2) to all infectious waste storage areas, processing, transformation, transfer and disposal facilities, other than sewage treatment systems that provide secondary treatment of waste.

B. All material that has been rendered non-infectious is not subject to the handling requirements of this section, provided:

(1) if it is an otherwise regulated, hazardous, special, or radioactive waste, it shall be handled according to regulations applicable to that type of waste;

(2) any person that processes or transforms infectious waste shall certify in writing on at least an annual basis, or upon any change that could affect the efficacy of the treatment that the waste has been rendered non-infectious by sterilization, incineration or another method approved by the secretary; a certification that the waste has been rendered non-infectious shall be provided to the generator, transporter, and disposal facility; the generator, processing or transformation facility, and disposal facility shall maintain copies of certifications for a period of three years and the records shall be made available to the department upon request; and

(3) the operator of the disposal facility applies daily cover as required in 20.9.5.9 NMAC prior to any compaction of the sharps.

C. The following storage and containment requirements apply to all infectious waste.

(1) Containment shall be in a manner and location which affords protection from animal intrusion, does not provide a breeding place or a food source for insects and rodents, and minimizes exposure to the public.

(2) Infectious waste shall be segregated by separate containment from other waste at the point of origin.

(3) Except for sharps, infectious waste shall be contained in plastic bags inside rigid containers. The bags shall meet the testing requirements specified by 40 CFR 173.197. All bags used for containment purposes shall be red or orange and clearly identified as specified in 20.9.8 NMAC 104 29 CFR 1910.145(f).

The bags shall be securely tied to prevent leakage or expulsion of solid or liquid wastes during storage, handling or transport.

(4) Sharps shall be contained for storage, transportation, transfer, processing, transformation, and disposal in leak-proof, rigid, puncture-resistant containers which are manufactured for the purpose of sharps containment and are taped closed or tightly lidded to preclude loss of contents.

(5) Rigid containers shall be labeled “biomedical waste”, or otherwise conspicuously labeled as holding infectious waste, or placed in disposable bags used for other infectious waste. Rigid containers shall meet or exceed the requirements of 49 CFR 173.197 including that the containers be:

(a) rigid;

(b) leak resistant;

(c) impervious to moisture;

(d) of sufficient strength to prevent tearing or bursting under normal conditions of use;

(e) sealed to prevent leakage during transport; and

(f) puncture resistant for sharps and sharps with residual fluids.

(6) If other waste is placed in the same container as regulated infectious waste, then the generator shall package, label and mark the container and its entire contents as infectious waste.

(7) Rigid infectious waste containers may be reused for infectious or noninfectious waste if they are thoroughly washed and decontaminated each time they are emptied or the surfaces of the containers have been completely protected from contamination by disposable, unpunctured or undamaged liners, bags, or other devices that are removed with the infectious waste, and the surface of the containers have not been damaged or punctured.

(8) Storage and containment areas shall protect infectious waste from the elements, be ventilated to the outdoors (unless refrigerated), provide refrigeration as necessary, be only accessible to authorized persons, and be marked with prominent warning signs on, or adjacent to, the exterior doors or gates. The warning signs shall be easily read during daylight from a distance of 25 feet.

(9) Generators of infectious waste, shall place sufficient absorbent material inside the rigid container or liner of the rigid container sufficient to absorb the entire amount of liquid present in the event of an unintentional release of contents, as specified in 49 CFR 173.197.

(10) Compactors, grinders or similar devices shall not be used to reduce the volume of infectious waste before the waste has been rendered non-infectious unless prior approval has been obtained from the department.

D. All generators of infectious waste shall dispose of the infectious waste at a facility permitted to process, store or dispose of infectious waste.

E. All infectious waste generation, processing, transformation, transfer, storage and disposal facilities subject to this section shall comply with the following operational requirements.

(1) Every person who generates, transports, stores, processes, or disposes of infectious waste shall prepare and maintain on file a management plan for the waste that identifies the type of waste the person generates or handles, the segregation, packaging, labeling, collection, storage, method of storage, and transportation procedures to be implemented, the 20.9.8 NMAC 105 processing, transformation or disposal methods that will be used, the transporter and disposal facility that will be used, and the person responsible for the management of the infectious waste.

(2) All infectious waste management facilities may only accept infectious waste that is accompanied by a manifest that contains the information required by 20.9.8.19 NMAC.

(3) Report to the secretary any delivery of unauthorized waste, contamination of any person, or other emergencies immediately upon recognition.

(4) Human fetal remains, as defined by the state medical investigator, when measured to be 500 grams or greater, shall be disposed by incineration or interment.

(5) Infectious waste consisting of recognizable human anatomical remains shall be disposed by incineration or interment, unless such remains are subject to different treatment or disposal standards due to contamination by a hazardous or radioactive substance. Recognizable human anatomical remains may be released to the patient, proper governmental authority, or designated family member for interment or incineration, as long as all forensic needs of the facility have been met and the release is not in violation of any other law.

F. Processing, transformation and disposal of infectious waste shall be by one of the following methods:

(1) incineration in a controlled air multi-chambered incinerator which provides complete combustion of the waste to carbonized or mineralized ash:

(a) ash from the incinerator shall be sampled in accordance with Subsection B of 20.9.8.11 NMAC;

(b) the sample shall be analyzed by the U.S. EPA test method 1311: toxic characteristics leaching procedure (TCLP) to determine if it is a hazardous waste; if hazardous, it shall be managed by applicable state regulations;

(c) the retention times and temperatures for each chamber shall be continuously measured and recorded, or other equivalent tests approved by the department to determine if it is still infectious shall be performed; if infectious, it shall be reincinerated in accordance with this section; and

(d) charge rates shall be maintained and recorded;

(2) sterilization by heating in a steam sterilizer so as to render the waste noninfectious:

(a) the operator shall have available and shall certify in writing that she or he understands written operating procedures for each steam sterilizer including time, temperature, pressure, type of waste, type of container(s), closure on container(s), pattern of loading, water content, and maximum load quantity;

(b) infectious waste shall be subjected to sufficient temperature, pressure and time to kill Geobacillus stearothermophilus spores or induce a complete color change in an approved steam sterilization integrator when either indicator is located in the center of the waste load being decontaminated;

(c) unless a steam sterilizer is equipped to continuously monitor and generate a printed paper record of time, temperature and pressure during the entire length of each sterilization cycle, a chemical indicator shall be attached to each package of infectious waste that will visually demonstrate at the end of the autoclave cycle that each package was exposed to a temperature of at least 250 degrees fahrenheit or 121 degrees celsius in the presence of steam under pressure was reached during the process; the original printed record generated by the autoclave must be maintained for three years; 20.9.8 NMAC 106

(d) each sterilization unit shall be evaluated for effectiveness with spores of Geobacillus stearothermophilus or approved steam sterilization integrator at least once each 40 hours of operation; and

(e) a written log shall be maintained for each sterilization unit which contains:

(i) date, time and load number for each load;

(ii) amount per load;

(iii)duration of the cycle; and

(iv) the operator’s name;

(3) discharge to a sewage treatment system that provides secondary treatment of waste, if the waste is liquid or semi-solid and approved in writing by the operator of the sewage treatment system; or

(4) other products or methods may be approved by order of the secretary which provide:

(a) a 6Log10 reduction in mycobacteria of Mycobacterium phlei or Mycobacterium bovis (BCG) or if specifically approved, other Mycobacterium species;

(b) a 4Log10 reduction in bacterial spores of Geobacillus stearothermophilus, Bacillus atrophaeus or if specifically approved, other species of sporeforming bacterium; and

(c) verification that the species used in Subparagraphs (a) and (b) of Paragraph (4) of this subsection are the species indicated and that the strain used is appropriate for the proposed method.

G. The following requirements and condition shall apply to any person seeking approval from the secretary for a treatment method under Paragraph (4) of Subsection F of this section:

(1) the person shall provide any information requested by the secretary within the time period specified by the secretary;

(2) the request for approval shall be approved, approved with terms and conditions, or denied by the secretary;

(3) within 45 days from the end of each calendar year, manufacturers of on-site treatment or processing products approved by the secretary shall submit an annual report to the department that includes:

(i) current manufacturer’s company name, contact names, addresses, and telephone numbers;

(ii) a current list of product consumers or clients in New Mexico identified as generators of infectious waste under Subsection A of 20.9.8.13 NMAC, with contact names, addresses, and telephone numbers;

(iii) proof of current registration with the U.S. EPA, if required under the Federal Insecticide, Fungicide, and Rodenticide Act;

(iv) a current material safety data sheet for any materials used in the treatment method;

(v) a current copy of the manufacturer’s instructions as printed on the product and a copy of the most recent operator’s manual, if not previously submitted; and

(vi) proof of current registration with the New Mexico department of agriculture, if required under the New Mexico Pesticide Control Act; 20.9.8 NMAC 107

(4) the secretary may withdraw the approval of an on-site processing product if the product fails to properly treat infectious waste as claimed, or if the on-site processing product or method is altered in any manner; to withdraw the approval, the secretary shall issue an order withdrawing the approval; the interested person may appeal the secretary’s order by filing a request for hearing within 30 days of the date of the secretary’s order; the procedures set forth in Adjudicatory Procedures – Environment Department, 20.1.5 NMAC shall apply to the appeal.

Nevada Medical Waste Regulations

Regulatory Framework

Nevada regulations do not require treatment of medical waste. Disposal in a permitted landfill according to approved practices is acceptable. However, until the waste has been either treated or disposed, it must be stored and collected according to the requirements of Nevada Administrative Code (NAC) 444.662. (Note: the Washoe County District Health Department and the Southern Nevada Health District in Clark County have infectious waste regulations that do require treatment before disposal.)

There is no comprehensive federal regulatory program for the management of medical waste. The US Occupational Safety and Health Administration (OSHA) has adopted regulations to limit workers’ occupational exposure to blood and other body fluids which may pose a risk of infection by bloodborne pathogens

The Nevada Administrative Code (NAC) contains the following regulations concerning the storage, collection, and disposal of medical waste:

444.589 “Medical waste” defined. “Medical waste” has the meaning as ascribed to it in 49 C.F.R. Part 173, Appendix G – “Definition of Regulated Medical Waste,” as that appendix existed on November 8, 1993. See: http://ndep.nv.gov/bwm/Docs/medical_waste_definition-49_cfr.pdf

444.646 Disposal of special wastes: Sewage sludge, septic tank pumpings and medical wastes; coverage of burial area.

1. medical wastes may be deposited at a disposal site only if provisions for such disposal are included in the operational plan and approved by the solid waste management authority.

2. A completed special waste burial area must be covered with a layer of suitable cover material compacted to a minimum uniform depth of 36 inches.

444.662 Storage of solid wastes before collection.

Medical wastes must be stored in watertight, tightly covered and clearly labeled containers that are resistant to corrosion and are in a safe location, inaccessible to the public. In addition, medical wastes must be stored in cleanable containers with liners approved by the solid waste management authority.

Medical wastes must not be deposited in containers with other solid wastes.

Medical wastes must be transported separately from other solid wastes to an approved disposal site and handled in accordance with a method approved by the solid waste management authority.

These regulations accomplish three things:

1. The following are included in the definition of medical waste: cultures and stocks of infectious agents, pathological wastes, human blood and blood products, sharps, contaminated animal wastes and isolation wastes. The definition exempts household waste and also medical waste that has been “treated and destroyed”.

2. A procedural requirement is established for the disposal of medical waste.

3. Minimum standards are established for the storage, labeling, segregating and transporting of medical waste.

Applicability Commercial, industrial and government facilities that generate medical waste and must comply with the above requirements include:

– Hospitals, clinics and other medical facilities

– Doctors’ and dentists’ offices

– Veterinarians’ offices

– Medical and veterinary research laboratories

– Home health care agencies that remove and transport medical waste away from the home

– Businesses that transport non-residential medical waste.

New York Medical Waste Regulations

What Medical Waste is Regulated?

Regulated medical waste (RMW) is material generated in research, production and testing of biologicals or health care such as:

What Institutions are Regulated?

Examples of regulated institutions include: hospitals, clinical laboratories, veterinarians, funeral homes, nursing homes, home health providers, physicians offices, research laboratories, pharmaceutical companies, colleges and universities (including basic medical or clinical microbiology laboratories), blood banks, company infirmaries, correctional facilities and waste management companies.

Proper Treatment and Disposal

Treatment and disposal of regulated medical waste requires a permit.

RMW must be properly treated to destroy disease-causing organisms prior to disposal at an authorized solid waste management facility.

Treatment includes autoclaving, incineration, or alternative treatment technologies (e.g., microwave, chemical disinfection etc.) or other methods that meet New York State’s performance standards. In addition,sharps must be destroyed prior to disposal.

Treated RMW may be disposed (if accompanied by a certificate of treatment form) at an authorized solid waste management facility.

Required Reports and Forms

All regulated institutions must complete the Medical Waste Tracking Form (PDF) (19 KB).

NYS RMW Regulatory Authority and Jurisdiction

New York State has provided regulatory oversight of RMW since the early 1980s and has adopted a comprehensive regulatory framework covering all aspects of handling, storage, treatment and disposal of this waste. Title 15 of Article 27 of the Environmental Conservation Law, 6 NYCRR Subparts 360-10 and 360-17, and Part 364 regulations, in conjunction with the Public Health Law 1389 aa-gg and 10 NYCRR Part 70 govern the activities of the New York State regulated community to properly manage RMW.

In accordance with these laws and regulations, both the New York State Department of Health (DOH) and the DEC jointly administer New York State’s RMW Program. For example, The DOH has jurisdiction for hospitals, freestanding diagnostic and treatment centers, residential health care facilities and clinical laboratories, and their on-site waste management procedures. The DOH is also responsible for developing treatment standards and approving alternative treatment technologies. DEC staff collaborates with the DOH to evaluate an alternative treatment system’s capacity to process RMW and on the classification of present and emerging RMW treatment technologies.

The DEC has oversight authority for all storage, treatment and destruction processes located on-site of facilities not under DOH jurisdiction (unless such facility is considered a commercial operation), for off-site transport of RMW, for all generators, tracking, responding to illegal disposal incidents, and for all off-site storage, transfer, treatment and disposal facilities. This complementary oversight as intended by the Legislature is necessary to ensure that all RMW generators operate under the same standards.

NYS RMW Management Practices

There are approximately 36,000 generators of RMW and 250,000 tons of RMW generated each year in New York State. One third of this volume is attributed to healthcare facilities such as nursing homes, hospitals, and clinical laboratories, while the other two thirds is generated by physician offices, blood establishments, colleges and universities, veterinarian and dental offices, funeral homes, research laboratories, pharmaceutical and biotechnology facilities.

Most RMW is disposed off of the site of generation. In accordance with both federal and state requirements, and to ensure containment, RMW (except medical waste sharps) is required to be placed in plastic bags and then packaged in single use (e.g., corrugated boxes) or reusable rigid (e.g., plastic) or semi-rigid, leak proof containers before transport. Once packaged, RMW is either transported to a designated secure storage or collection area within the facility for third party pick-up, or to a generator’s on-site treatment facility.

Once RMW is collected by third party transporters, the waste is either transported to a permitted transfer facility or directly to an authorized treatment facility. The DEC annually permits approximately 100 RMW transporters. DEC has also issued permits to approximately 35 RMW transfer and treatment facilities.

RMW Federal Laws and Regulations

Since the federal Medical Waste Tracking Act sunset in 1991, the only federal rules related to RMW are concerned with packaging for RMW interstate transport (U.S. Department of Transportation Regulations) and handling of blood borne pathogens (Occupational Safety and Health Administration Regulations) in occupational settings. In addition, other federal laws (e.g., the Resource Conservation and Recovery Act; Comprehensive Environmental Response, Compensation, and Liability Act; and, the Clean Air Act) and regulations (e.g., U.S. Postal Service; Food and Drug Administration; U.S. Department of Agriculture; and, U.S. Public Health Service) govern the handling, transport and disposal of certain components of RMW.

Assistance from DEC

DEC provides technical assistance to many large quantity generators on RMW treatment, management and disposal. Contact our Division of Materials Management, Bureau of Solid Waste Management at 518-402-8678.

Ohio Medical Waste Regulations

Infectious Waste

Ohio EPA regulates the generation and treatment of infectious waste, as authorized by Chapter 3734 of the Ohio Revised Code. Businesses generating more than fifty (50) pounds of infectious waste in any calendar month are required to register with Ohio EPA and, among other requirements, ensure all infectious waste is treated prior to ultimate disposal. Approved treatment technologies may be used onsite, or infectious wastes may be sent to a commercial treatment facility.

Ohio’s infectious waste regulations contain approved treatment methods. Most commonly, autoclave and incineration technologies are used to treat infectious waste prior to disposal. Additional approved treatment methods include chemical treatment utilizing a sodium hypochlorite solution (bleach) for stocks and cultures; applied heat encapsulation for sharps; and chemical treatment utilizing peracetic acid and grinding. A business may submit a request for site-specific or statewide approval of an alternative treatment technology.

Transportation of infectious waste (hazardous material) is regulated by the Public Utilities Commission of Ohio (PUCO). For more information regarding the transportation of infectious waste, please contact PUCO by telephone at (800) 686-PUCO (7826).

Oklahoma Medical Waste Regulations

REGULATED MEDICAL WASTE MANAGEMENT

PART 1. GENERAL PROVISIONS

Section 252:515-23-1. Applicability and exclusions 252:515-23-2. Definitions 252:515-23-3. Disposal of untreated, regulated medical waste 252:515-23-4. Treatment 252:515-23-5. Compacting prohibited

PART 3. OPERATIONAL REQUIREMENTS FOR ALL COMMERCIAL REGULATED MEDICAL WASTE PROCESSING FACILITIES

252:515-23-31. General 252:515-23-32. Radiation 252:515-23-33. Contingency plan 252:515-23-34. Emergency response 252:515-23-35. Storage

PART 5. ADDITIONAL OPERATIONAL REQUIREMENTS FOR COMMERCIAL REGULATED MEDICAL WASTE INCINERATORS

252:515-23-51. Time and temperature 252:515-23-52. Burning efficiency 252:515-23-53. Interlocks 252:515-23-54. Tests 252:515-23-55. Monitoring 252:515-23-56. Residues

PART 1. GENERAL PROVISIONS

252:515-23-1. Applicability and exclusions

(a) Federal requirements. Persons or facilities involved in the handling, storage, packaging, labeling, and/or transportation of regulated medical waste may be subject to requirements of the federalDepartmentofTransportation(49CFRPart173),thefederalOccupationalSafety andHealth Administration (29 CFR 1910.1030), or other federal or state agencies.

(b) Commercial processing facilities. Commercial regulated medical waste processing facilities are subject to the requirements of Parts 1 and 3 ofthis Subchapter as well as Part 3 of OAC252:515- 19.

(c) Commercial incinerators. Commercialregulatedmedicalwaste incinerators are subject to the requirements of (b) of this Section and Part 5 of this Subchapter.

(d) Shared servicesfacilities. Shared servicesfacilitiesshall meet the standards of OAC252:515- 23-32(b), 33, 34, and 35, but are not required to obtain DEQ approval.

(e) Exclusions.

(1) General. The following are notsubject to the requirements ofthis Subchapterifthey do not contain any regulated medical waste:

(A)wastesgeneratedbytheprocessingor caringforanimals, exceptforuntreatedsharps and those wastes identified in subparagraph (F) of the definition of “regulated medical waste”;

(B) regulated medical wastes treated in accordance with OAC 252:515-23-4;

(C) biological products distributed for any purpose other than treatment and disposal;

(D)diagnostic specimens shipped to a qualified diagnostic laboratory;

(E) laundry or medical equipment conforming to 29 CFR 1910.1030;

(F) corpses, remains, and/or anatomical parts intended for ceremonial interment or cremation.

(2) Hazardous waste. Hazardous waste is not subject to the requirements of this Subchapter, but shall be subject to the requirements of OAC 252:205.

(3) Household waste. Household wastes are notsubject to the requirements ofthis Subchapter even if they contain regulated medical wastes generated in the household from treatment of a resident of the household.

252:515-23-2. Definitions

The followingwords andterms,whenused in thisSubchapter,shall have the followingmeaning, unless the context clearly indicates otherwise:

“Commercial regulated medical waste incinerator” means a waste processing facility operated as a business for profit for incineration of regulated medical wastes generated by others.

“Commercial regulated medical waste processing facility” means a facility operated as a businessfor profit that is designed and operated principally forthe purpose of processing, including transferof,regulatedmedicalwastes generated byothers. Such facilitiesshallinclude those engaged in the processing of regulated medical waste on mobile vehicles at a generator location.

“Commercial transporter” means an owner/operator of any vehicle transporting regulated medical waste generated by others as a business for profit.

“Etiologic agent” means a viable microorganism, oritstoxin, that causes ormay cause disease in humans or animals, and includes those agents listed in 42 CFR 72.3, and any other agent that causes or may cause severe, disabling or fatal disease. The term “etiologic agent” is synonymous with the term “infectious substance” as defined in 49 CFR 173.134.

“Generator” means the owner/operator of any facility, institution, or business that produces regulated medical waste in any quantity.

“Microbial inactivation” means a 4Log10 (99.99%) or greater reduction of:

(A)B.stearothermophilus(ATCC7953) when utilizing steamsterilization fortreatment of regulated medical waste;

(B) B.subtilis (ATCC 19659) when using dry heat or microwave methods for treatment of regulated medical waste; or

(C) other appropriate indicator organisms and kill efficacy for the treatment method chosen and as approved by the DEQ.

“Shared services facility” means a hospital or clinic that provides treatment of regulated medical waste generated by anotherinstitution (including doctor’s offices, medical laboratories and nursing homes) for the purpose of providing a service rather than generating revenue.

“Sharps” mean hypodermic needles, Pasteur pipettes,scalpel blades, blood vials, needles with attached tubing, culture dishes, and glassware such as used slides and cover slips.

“Small quantity regulated medical waste generator” means a generator that generates less than sixty (60) pounds of regulated medical waste per month from one physical location.

“Untreated sharps” means sharps that are to be disposed for any reason, but have not been treated in accordance with OAC 252:515-23-4(b).

252:515-23-3. Disposal of untreated, regulated medical waste

(a) MSWLF. The disposal of the following is prohibited in a MSWLF, a municipal solid waste receptacle or a municipal solid waste transfer station:

(1) all quantities of untreated sharps, even if generated by a small quantity regulated medical waste generator; and

(2) all quantities of other untreated, regulated medical waste, except that generated by a small quantity regulated medical waste generator.

(b) Liquids. Liquid regulated medical wastes (except chemical wastes, or antineoplastic or cytotoxic drugs) may be discharged into the collection system of a POTW within the generating facility if:

(1) written approval of the POTW has been obtained; and

(2) the POTW provides secondary treatment.

252:515-23-4. Treatment (a) Methods. Regulated medical waste must be treated by one of the following methods: (1) incineration in an incinerator that:

(A)is designed for the destruction of regulated medical waste;

(B) will consistently achieve microbial inactivation; and

(C) is permitted by the DEQ’s Air Quality Division and operated in accordance with such permit;

(2) microwave sterilization, or steam sterilization at sufficient temperature and pressure, for sufficient time to consistently achieve microbial inactivation;

(3) chemical disinfection where contact time, concentration and quantity of the chemical disinfectant are sufficient to consistently achieve microbial inactivation; or

(4) anyothertreatmentmethod demonstrated to be effective in consistentlyachievingmicrobial inactivation.

(b) Untreatedsharps. Untreated sharpsmust be treated eitherin accordancewith (a)ofthisSection or in another way to minimize the potential for puncture wounds, such as placement in specially designed sharps containers of rigid plastic or a rigid puncture-resistant container and filled with a solidifying material, or other such methodsthat will seal the sharp to minimize the risk of puncture wounds.

252:515-23-5. Compacting prohibited

Regulated medical waste shall not be compacted.

PART 3. OPERATIONAL REQUIREMENTS FOR ALL COMMERCIAL REGULATED MEDICAL WASTE PROCESSING FACILITIES

252:515-23-31. General

(a) Other requirements. Commercial regulated medical waste processing facilities are subject to the requirements of Part 3 of OAC 252:515-19.

(b) Acceptable wastes. Only regulated medical wastes shall be accepted at a regulated medical waste processing facility.

(c) DEQ approved plan. A DEQ approved plan shall be implemented for:

(1) excluding wastes that are not to be processed;

(2) safely storing wastes until proper processing and disposal occurs; and

(3) responding to emergencies.

(d) Decontamination facilities. Decontamination facilities must be provided.

252:515-23-32. Radiation

(a) Screening and handling. A DEQ approved procedure shall be implemented for screening wastes and handling radioactive wastes.

(b) Detection system. Fixed radiation detection monitors, capable of detecting radiation sources as small as 0.25 millicuries of Cs137, must be installed to monitor incoming wastes.

(c) Interlock system. Automated waste processing units must have an interlock system to automatically stop upon detection of radiation.

(d) Hand-held detectors. Hand-held radiation detectors must be used to screen wastes when the fixed radiation detectors detect radioactive wastes.

(e) Segregation of radioactive wastes. When radioactive wastes are detected, they must be segregated from the remainder of the wastestream for proper management.

252:515-23-33. Contingency plan

A DEQ approved contingency plan shall be implemented that addresses:

(1) over-packing;

(2) decontaminating vehicles and containers;

(3) safely storing improper wastes and poorly packaged wastes;

(4) proceduresforvisual inspection of containersto detect leaks or other problemsin packaging;

(5) procedures for re-packaging defective, problematic or leaking waste containers detected during visual inspection;

(6) alternative management of wastes in the event of equipment malfunction, emergencies or other unforeseen situations; and

(7) include a narrative description of the storage area, including size, location and security.

252:515-23-34. Emergency response

Copies of emergencyresponse agreements with applicable local agenciesshall bemaintained in the operating record and submitted to the DEQ.

252:515-23-35. Storage

All waste shall be processed or placed into refrigerated storage, at 45F, within 24 hours of delivery. If processing has not occurred within 96 hours, waste shall be transported to an alternate permitted site.

PART 5. ADDITIONAL OPERATIONAL REQUIREMENTS FOR COMMERCIAL REGULATED MEDICAL WASTE INCINERATORS

Incinerators must maintain a minimum temperature of:

(1) 1400F, ± 25°F,inthe primary chamber forsufficienttimetoachievemicrobial inactivation; and,

(2) 2000F, ±25°F, in the secondary chamberfor a minimum residence time oftwo (2) seconds.

252:515-23-52. Burning efficiency

The incinerator must be operated such that no unburned materials are visible in the residue ash. 252:515-23-53. Interlocks

Incineratorsmust be equippedwith automatic loading and protective interlocksto preventwaste from entering the secondary chamber when the temperature is below 2000 F.

252:515-23-54. Tests

(a) Routine periodic tests. The incinerator design must provide sample injection and collection ports to enable the owner/operator or the DEQ to conduct periodic tests.

(b) Demonstration. Prior to operation, the owner/operator must conduct a demonstration showing complete destruction of a chemical which requires 2000°F for destruction and which is introduced into the unit under normal operating procedures.

252:515-23-55. Monitoring

(a) Monitoringrequired. Theincineratorshallhavecontinuousmonitoringandrecordingforwaste feed, fuel and combustion gas flows; oxygen and carbon monoxide, and temperature.

(b) Instrument calibration. Monitoring devices shall be routinely calibrated in accordance with manufacturer’srecommendations.

(c) DEQ may monitor. Incinerators shall have the capability for the DEQ to connect its own monitoring or calibration test equipment.

(d) Monitoring data retention. Monitoring data shall be maintained for at least two years.

(e) Excursions. Inthe eventmorethanthirtyexcursionsfromtheoperatingparametersoccurwithin any calendar month, the owner/operator shall shut down operations until such time as repairs are made and documented engineering analysis shows how the cause has been corrected.

252:515-23-56. Residues

Ash residue shall bemanaged in accordance with the NHIWmanagementrequirements of OAC 252:515-31.

Oregon Medical Waste Regulations

INFECTIOUS WASTE MANAGEMENT

Purpose of Infectious Waste Administrative Rules

The purpose of OAR 333-056-0020 through 333-056-0050 is to define terms related to infectious waste and to prescribe acceptable methods of storage and treatment of infectious waste.

Infectious Waste Storage Times and Temperature

(1) Infectious waste shall be segregated from other wastes by separate containment at the point of generation in accordance with ORS 459.390.

(2) Pathological waste, biological waste, and cultures and stocks shall be treated or disposed of pursuant to OAR 333-056-0010 through 333-056-0030 within seven days of generation, unless it is refrigerated (between 33 and 48 degrees Fahrenheit) or frozen (less than 32 degrees Fahrenheit). Refrigerated or frozen infectious waste may be stored 30 days prior to treatment or disposal.

(3) Generators that produce 50 pounds or less of infectious waste in any calendar month shall be exempt from the requirements pertaining to storage times and temperatures.

Statutory/Other Authority: ORS 431.110, 433.004, 459.395, 459.390

Statutes/Other Implemented: ORS 431.110, 433.004, 459.395, 459.390

History:

PH 17-2020, amend filed 03/26/2020, effective 04/06/2020

PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0070

HD 15-1990, f. 6-5-90, cert. ef. 7-1-90

Infectious Waste Treatment

(1) Pathological wastes shall be treated by incineration in accordance with ORS 459.395.

(2) Cultures and stocks shall be incinerated as described in ORS 459.395(1) or sterilized by other means prescribed by this rule:

(a) Incineration, in compliance with all applicable rules established by the Environmental Quality Commission;

(b) Sterilization with saturated steam in a pressurized vessel dedicated to infectious waste treatment. Operating procedures, which must be developed and implemented, shall include at least the following:

(A) Adoption of standard written operating procedures for each steam sterilizer including time, temperature, pressure, type of waste, type of container(s), type of closure on container(s), pattern of loading, and maximum load quantity. The manufacturer’s recommendations shall be taken into account;

(B) Methods for monitoring, recording or temperature-measuring-devices during each complete cycle to ensure that the manufacturer’s recommended temperature is attained for the recommended amount of time in order to achieve sterilization of the entire load. Temperature measuring devices shall be checked for calibration at least annually;

(C) Methods for using heat-sensitive tape or other device designed to indicate attainment of adequate sterilization conditions, for each container;

(D) Methods for at least monthly use of the biological indicator Bacillus stearothermophilus, or equivalent, placed at the center of a load processed under standard operating conditions, to confirm the attainment of adequate sterilization conditions; and

(E) Methods for maintenance of records pertaining to paragraphs (2)(a)(A), (B) and (D) of this rule. These records shall be maintained and available for Division review for a period of not less than one year.

(c) Treatment by another method that meets the following criteria:

(A) The specific processes of the method have been tested under the conditions in which the method would be used in Oregon for the treatment of infectious waste. Such testing has demonstrated that the method is effective in rendering infectious agents non-infectious by showing bactericidal efficacy against at least spore-forming bacteria and a Mycobacterium. The testing methodology, test results, and documentation thereof must be considered scientifically valid by the Division. The determination of validity requires, but is not limited to:

(i) The testing methodology follows basic scientific principles or objectivity and is fully documented;

(ii) The results of the testing are fully documented. Raw data are made available to the Division if they are requested by the Division;

(iii) The testing has been done by a scientist with an advanced degree in microbiology and with a record of having published scientific research results in a peer-reviewed journal;

(iv) The report of the testing methodology and results, together with the statement “This report is an accurate and complete account of the test methods I performed and the test results I obtained” have been signed by the scientist(s) who performed the testing; and

(B) Any discharges into air or water and any solid waste resulting from the method meet the requirements of the laws and administrative rules of the Oregon Department of Environmental Quality; or

(C) The Environmental Quality Commission has approved the method and has accepted that method by administrative rule.

(3) Liquid or soluble semi-solid biological wastes shall be treated in accordance with ORS 459.395.

(4) Sharps shall be treated and disposed of in accordance of ORS 459.395(4).

(5) Methods of treatment which have not been delineated in this rule or approved by the Division or the Environmental Quality Commission, as applicable, are not permitted.

Statutory/Other Authority: ORS 431.110, 433.004, 459.395, 459.390

Statutes/Other Implemented: ORS 431.110, 433.004, 459.395, 459.390

History:

PH 17-2020, amend filed 03/26/2020, effective 04/06/2020

PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0060

HD 29-1994, f. & cert. ef. 12-2-94

Reverted to HD 15-1990, f. 6-5-90, cert. ef. 7-1-90

HD 13-1992(Temp), f. & cert. ef. 12-23-92 (and corrected 12-30-92)

Reverted to HD 15-1990, f. 6-5-90, cert. ef. 7-1-90

HD 20-1991(Temp), f. & cert. ef. 11-8-91

HD 15-1990, f. 6-5-90, cert. ef. 7-1-90

Pennsylvania Medical Waste Regulations

INSPECTION REPORT – REGULATED MEDICAL / CHEMOTHERAPEUTIC

WASTE (RMCW) GENERATOR

SEGREGATION

Regulated medical waste, pathological waste and chemotherapeutic waste is properly segregated.

Segregated waste is placed in separate containers (used sharps that qualify as regulated medical waste may be placed in a chemotherapeutic waste used sharps container).

Bags used as containers to segregate regulated medical or pathological waste are fluorescent orange, orange-red, or red.

Bags used as containers to segregate chemotherapeutic waste are yellow.

BASIC STORAGE REQUIREMENTS

Integrity of containers maintained, leakage and releases prevented, and containers provide protection from water, rain and wind.

Spread of RMCW agents prevented; vectors controlled.

Waste maintained in a nonputrescent state; odors prevented.

Unauthorized access to waste prevented; enclosures and containers secured.

Enclosures and containers marked with prominent warning signs.

Enclosures capable of being readily maintained in a sanitary condition; exhaust air is ventilated.

RMCW not commingled with other waste in the same container.

STORAGE CONTAINERS

Containers are leakproof on sides and bottom, maintained upright, impervious to moisture, strong enough to prevent puncturing, tearing or bursting.

Used sharps are placed in containers that are rigid, tightly lidded and puncture resistant.

Regulated medical waste fluids in quantities greater than 20 cubic centimeters and chemotherapeutic waste fluids are in containers that are break resistant and tightly lidded or tightly stoppered.

When used as the only containers to segregate and store waste, bags are double or multiple bagged and meet the following requirements:

               GENERATOR RESPONSIBILITIES

Securely tied upon packaging

Constructed of material of sufficient single thickness to meet required ASTM standards

Properly certified to ensure ASTM standards have been met

Have sufficient seam strength

Are fluorescent orange, orange-red or red for regulated medical waste and yellow for chemotherapeutic waste; no heavy metal content in colorants

MARKING OF CONTAINERS

For onsite or offsite transport, the outermost containers of regulated medical or chemotherapeutic waste (unless it’s a vehicle or conveyance) are properly labeled.

If outermost container is a vehicle or conveyance, including a roll-off:

Waste is from a single generator

Vehicle or conveyance is transported offsite every 30 days

Vehicle or conveyance complies with §284.513

Vehicle or conveyance displays date that it was full or sealed, or generator maintains record of date

Outside of vehicle or conveyance displays name, address and telephone number of generator, if waste is transported offsite

Nonwall-mounted sharps containers have correct colored markings and sufficiently identify waste type.

All markings are clearly legible and all labels (if used) are securely attached.

DURATION OF STORAGE OF RMCW FOR GENERATORS

RMCW stored for no longer than 30 days from date the container is full or sealed (whichever occurs earlier).

If waste becomes putrescent during 30-day storage when container is full or sealed, waste is moved offsite within three (3) business days.

REUSE OF CONTAINERS

Nonrigid containers are properly managed and not reused.

Corrugated fiberboard containers reused only if container protected from waste.

Rigid, non-fiberboard containers reused only if container protected from waste or container has been decontaminated by an approved method.

               GENERATOR RESPONSIBILITIES

Generator prepares a log or shipping paper as required.

Exception reporting as required.

Manifest copies maintained for at least two (2) years, unless extended.

Rhode Island Medical Waste Regulations

    Identification and Segregation of Regulated Medical Wastes

1. Generators shall comply with the requirements of this section from the time and location that an item becomes regulated medical waste.

2. Generators shall comply with § 1.8 of this Part for on-site storage.

3. Training/Notification Requirement: Generators shall notify in writing all employees involved with the identification and segregation of regulated medical wastes of the provisions in § 1.6 of this Part. This training/ notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Identification

1. A person who generates a medical waste within the State of Rhode Island shall determine if that waste is a regulated medical waste. Any wastes that contain regulated medical waste mixed with general solid waste shall be managed as regulated medical wastes.

2. Any regulated medical wastes which meet the definition of “hazardous waste”, or which are mixed with hazardous wastes shall be managed as hazardous waste in accordance with the most current DEM Rules and Regulations for Hazardous Waste Management (Subchapter 10 Part 1 of this Title).

C. Segregation

Generators shall segregate regulated medical waste from the general waste stream to the maximum extent practicable to ensure the special handling and treatment required by these regulations. Separation from the general waste stream shall occur at the point at which the regulated medical waste is generated.

1. Generators shall segregate regulated medical wastes into the following groups:

a. Sharps and unused sharps, including sharps containing residual fluid;

b. Fluids in bulk quantities (quantities greater than twenty cubic centimeters (20 cm3));

c. Human Pathological wastes as defined in § 1.2(C) of this Part.

d. Other regulated medical wastes.

2. Regulated medical wastes shall be placed in suitable containers, according to the requirements of § 1.7 of this Part, at the source of origin (e.g., patient room, operating room, etc.).

3. If other solid waste is placed in the same container(s) as regulated medical waste, then the entire contents of the container(s) shall be managed as regulated medical waste and shall meet all the requirements of these regulations.

4. If a generator manages all solid waste as regulated medical waste, the identification and segregation requirements of § 1.6 of this Part need not be met. However, the entire solid waste stream of this generator shall then be managed as regulated medical waste and shall meet all remaining handling and management requirements of these regulations.

     General Packaging and Containment Requirements

Regulated medical waste shall be properly packaged to assure effective containment throughout the handling, storage, transport, and treatment process. In addition to the specific packaging and containment requirements for each category of regulated medical waste contained in §§ 1.7(B) and (C) of this Part, the following general requirements shall be met before transporting or offering for transport such waste off-site or within the generating facility:

1. Generators shall ensure that all regulated medical waste is placed in a container or containers that are:

a. Rigid;

b. Leak resistant;

c. Impervious to moisture;

d. Of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling; and,

e. Sealed to prevent leakage during transport.

2. Materials for packaging shall be strong enough to remain intact during whatever type of handling, storage, and transport the container(s) may undergo.

3. Mechanical compaction of regulated medical waste shall not be conducted prior to treatment and/or disposal, unless the mechanical compaction and treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste.

4. Training/Notification Requirement: Generators shall notify in writing all employees involved with packaging and containment of regulated medical wastes of the provisions in § 1.7 of this Part. This training/ notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Packaging Requirements for Sharps

1. In addition to the general packaging and containment requirements for regulated medical wastes in § 1.7(A) of this Part, all sharps and unused sharps, including sharps with residual fluids, shall be packaged in containers that are puncture resistant. Any sharps placed into such a container shall not be manipulated inside the container and/or shall not be removed from said container under any circumstances. The sharps shall be placed directly into the container without recapping, clipping, bending, or breaking unless one of the following criteria are met:

a. The employer can demonstrate that the requirements of this section are not feasible for a specific medical procedure; or,

b. Such recapping or needle removal is accomplished through the use of a mechanical device or one-handed technique specifically approved in writing by the Director.

2. Sharps containers shall be assembled and utilized as intended by the manufacturer at all times while in use. Sharps containers with openings large enough to allow entry of any human hand shall also be subject to any additional physical and/or administrative controls necessary to prevent access by the public during normal conditions of use.

3. The container shall be sealable in a manner that prevents spillage of contents during transport. The container shall identify the contents as regulated medical waste by displaying the Universal Biohazard Symbol on the outside of the container.

C. Packaging Requirements for Fluids in Bulk Quantities

In addition to the general packaging and containment requirements for regulated medical wastes in § 1.7(A) of this Part, human blood and blood products and body fluids in quantities greater than twenty cubic centimeters (20 cm3) shall be packaged in containers that are break resistant and tightly lidded or stoppered. The container shall identify the contents as regulated medical waste by displaying the universal biohazard symbol on the outside of the container.

D. Packaging Requirements for Human Pathological Wastes

In addition to the general packaging and containment requirements for regulated medical wastes contained in § 1.7(A) of this Part, pathological wastes shall be placed in a container marked or labeled with the words “pathological waste”, “path waste”, “pathology waste” or “incinerate only” or other labels approved by the Department on the lid or on the sides. Any waste placed in a container so marked must be managed as pathological waste in accordance with the requirements of these regulations.

E. Packaging Requirements for Animal Pathological Waste

In addition to the general packaging and containment requirements for regulated medical wastes contained in § 1.7(A) of this Part, Carcasses of animals contaminated with highly communicable endemic animal diseases listed in § 1.22 of this Part, shall be handled in accordance with special handling instruction in § 1.22 of this Part.

F. Packaging and Containment Requirements for Other Regulated Medical Wastes

In addition to the general packaging and containment requirements for regulated medical wastes in § 1.7(A) of this Part, those regulated medical wastes which are not sharps or fluids in bulk quantities, (including, but not limited to, cultures and stocks, non-liquid pathological wastes, non-liquid animal wastes (where the waste presents a risk of zoonotic disease), non-liquid isolation wastes, materials saturated with blood) shall be packaged in either rigid containers that are designed to be tightly sealable or in plastic bags that meet the following requirements:

1. The plastic bags shall be impervious to moisture and be tear resistant;

2. The plastic bags shall be a distinctive red or orange color, or clear (i.e., without color). If a clear bag is used then the universal biohazard symbol shall be appropriately displayed on the bag;

3. In order to allow the use of “single plastic bags”, the bags shall be constructed of material of sufficient single thickness strength to pass the 165 gram dropped dart impact resistance test as prescribed by the American Society for Testing and Materials (ASTM) Dart Test (ASTM Standard #D 1709 91) and certified by the manufacturer. Otherwise, “double bagging” (i.e., the use of two plastic bags, one inside the other) is required.

4. A container (e.g., a step can) used on-site to hold regulated medical waste shall have either a red or orange plastic bag plainly visible; or if a clear bag is used then the universal biohazard symbol shall be displayed on the container as well as on the bag.

    Storage of Regulated Medical Wastes

A. Applicability

1. Any person who stores regulated medical waste prior to treatment or disposal on-site or transport off-site shall comply with the storage requirements of this section.

2. Training/Notification Requirement: Generators shall notify in writing all employees involved with the storage of regulated medical wastes of the provisions in § 1.8 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Exemptions

Sharps containers, currently in use, are exempt from the generator storage requirements provided they meet all the requirements in §§ 1.7(A) and (B) of this Part.

C. General Storage Requirements

1. The regulated medical waste shall be stored in a manner and location which maintains the integrity of the packaging and provides protection from flooding and from adverse weather conditions such as rain, snow, ice, sleet, hail, and wind. All areas used for the storage of regulated medical waste shall be constructed of finished materials that are impermeable to moisture and capable of being easily maintained in a sanitary condition.

2. On-site storage areas shall be restricted to authorized personnel. Outdoor storage areas, such as dumpsters, sheds, tractor-trailers, or other storage areas, that contain regulated medical waste shall be securely locked in order to prevent unauthorized access.

3. The regulated medical waste shall be stored in a manner that prevents access by, and does not provide a breeding place or a food source for, insects, rodents, or other animals.

4. The storage area shall be clearly identified as containing regulated medical waste through the posting of universal biohazard signs or signs containing the following wording: “medical waste” or “regulated medical waste.”

5. The regulated medical waste shall be maintained in a non-putrescent state. Total storage of regulated medical waste shall not exceed fifty (50) pounds or seven (7) calendar days, whichever condition shall allow storage for the longer period of time. The seven-day storage period shall not include legal holidays and begins on the date the container was filled or was no longer used for collection at the point of generation. Storage of regulated medical waste at a licensed treatment, storage and disposal facility shall be governed by the applicable requirements for those facilities in these regulations and/or the facility’s permit conditions.

6. Regulated medical waste shall not be compacted, undergo grinding, or be subject to violent mechanical stress on-site unless the regulated medical waste has been treated prior to compaction, grinding, or other mechanical stress; or, unless the compaction, grinding, or mechanical stress and the treatment are part of a single, self-contained process that does not place employees or the public at risk of exposure to untreated regulated medical waste.

    Decontamination Standards for Reusable Containers

A. Applicability

1. Generators, transporters, intermediate handlers, and destination facility owners and operators shall comply with the requirements of this section with respect to reusing containers.

2. Training/Notification Requirement: Generators shall notify in writing all employees involved with the decontamination of reusable containers for regulated medical wastes of the provisions in § 1.9 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Standards

1. All non-rigid packaging and inner liners used for the packaging of medical waste shall be managed as regulated medical waste and shall not be reused.

2. Any container used for the storage and/or transport of regulated medical waste and designated for reuse once emptied shall be decontaminated after each use. Decontamination can be accomplished by chemical disinfection, steam sterilization, thermal inactivation, or other suitable process that is appropriates both for the type of container to be decontaminated and for the type of contamination present. The facility or generator responsible for decontamination must submit sampling protocols and results to demonstrate the technology, as installed, is providing adequate decontamination.

3. If any container used for the storage and/or transport of regulated medical waste is for any reason not capable of being rendered free of contamination in accordance with the requirements of § 1.9(B)(2) of this Part, the container shall be managed (i.e., labeled and treated and/or disposed of) as regulated medical waste.

    Labeling and Marking Regulated Medical Waste for Off-Site Transport

A. Applicability

1. All containers used for the packaging and containment of regulated medical wastes shall be labeled with the universal biological hazard symbol or shall be clearly labeled as containing regulated medical waste. In addition, all packages or containers which will be transported or offered for transport off-site shall meet the labeling and marking requirements of § 1.11 of this Part.

2. Training/Notification Requirement: Generators shall notify in writing all employees involved with the labeling and marking of regulated medical waste for off-site transport of the provisions in § 1.11 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. Labeling Requirements

Generators shall label each package or container of regulated medical waste with a water-resistant label affixed to or printed on the outside of the container. The label shall include the words “medical waste,” or display the universal biohazard symbol. Red plastic bags used, as inner packaging need not display a label.

C. Marking (Identification) Requirements

Generators and intermediate handlers shall mark each package or container of regulated medical waste according to the following marking requirements before the waste is transported or offered for transport off-site:

1. The outermost surface of each package or container prepared for shipment shall be marked or labeled with water-resistant paint/labels of sufficient dimension and contain the following information:

a. Generator’s or intermediate handler’s name;

b. Generator’s or intermediate handler’s address;

c. Transporter’s name (if applicable);

d. Transporter’s Rhode Island regulated medical waste transporter permit number (if applicable);

e. Date of shipment (date of off-site transport); and,

f. Identification of contents as medical waste.

2. When regulated medical waste is transported by more than one transporter, each transporter other than the transporter who accepted the waste from the generator shall affix a water-resistant identification tag on the outside of the secondary container. Such tag shall be at least three inches by five inches and shall be affixed in such manner as not to obscure previously affixed identification tags. Such tag shall indicate in indelible writing the name, address, business location, and Rhode Island regulated medical waste transporter permit number of the transporter affixing the tag and the date such transporter accepted the waste.

    Generator Requirements for Off-Site Transportation of Regulated Medical Waste

A. Applicability

1. A person who generates regulated medical waste and whose generating facility is located in Rhode Island shall determine if that waste is a regulated medical waste (as defined in §§ 1.2(C) and 1.5 of this Part).

2. Any generator that transports off-site or offers for transport off-site any regulated medical wastes shall comply with all requirements for such transport set forth in §§ 1.6 through 1.9, and 1.11 of this Part.

3. A generator of regulated medical wastes shall determine the quantity of regulated medical wastes generated in a calendar month, and the quantity transported or offered for transport off-site for treatment, destruction, or disposal.

4. Vessels at port in Rhode Island are subject to the requirements of this section for those regulated medical wastes that are transported ashore in Rhode Island. The owner or operator of the vessel and the person(s) removing or accepting waste from the vessel are considered co-generators of the waste.

5. A generator that treats and destroys or disposes of regulated medical waste on-site (e.g., incineration, burial or sewer disposal covered by § 307(b) through (d), of the Clean Water Act) is not subject to tracking requirements for that waste. However, generators of regulated medical waste with on-site incinerators are subject to DEM on-site incinerator requirements.

6. Generators of regulated medical waste with on-site treatment and/or destruction system(s) are subject to the requirements of § 1.12 of this Part. In addition, generators who treat and destroy regulated medical waste are subject to §§ 1.6 through 1.10 of this Part. Generators who treat or dispose of regulated medical waste on-site may also be subject to additional Federal, State, or local laws and regulations.

7. Training/Notification Requirement: Generators shall notify in writing all employees involved with the off-site transportation of regulated medical wastes of the provisions in § 1.13 of this Part. This training/notification shall be accomplished through the use of a medical waste procedure manual and/or through appropriate training materials.

B. General Requirements

Generator shall send regulated medical waste only to a permitted facility. Except as provided below, he/she shall not offer regulated medical waste to a medical waste transporter that does not have a medical waste transporter permit number and a valid RI medical waste transporter permit as indicated by an official sticker on each transportation unit. Generators shall use transporters who have been issued a Rhode Island regulated medical waste transporter permit number by the Rhode Island Department of Environmental Management,

1. Generators of fifty (50) pounds or more of regulated medical waste per calendar month: Generators who generate, transport, or offer for transport off-site fifty (50) pounds or more of regulated medical waste in a calendar month are subject to the requirements of §§ 1.6 through 1.11 of this Part and all requirements of this Section for each shipment of regulated medical waste.

2. Small Quantity Generator(s): Small quantity generators are subject to the requirements of §§ 1.6 through 1.11 of this Part and are exempt from:

a. The requirement to use a transporter who has been issued a Rhode Island regulated medical waste transporter permit; and,

b. The requirement to use a tracking form; and,

c. The requirements of § 1.13(C) of this Part;

d. The exemption(s) contained in §§ 1.13(B)(2)(a) through (c) of this Part shall only be applicable if the following conditions are met:

(1) The regulated medical waste is transported from the original generation point to a satellite facility or central collection point owned by the generator.

(2) From the time the waste is received at the central collection point, the generator must store and ship the waste in accordance with all other generator requirements of these regulations, including requirements to use a medical waste tracking form.

(3) Small quantity generators and crime scene cleanup contractors that transport regulated medical waste between satellite facilities or to a central collection point shall apply to the Department for a Letter of Authorization. This authorization shall last for a period of three (3) years, after which time the generator must reapply.

(4) Notwithstanding the requirements of § 1.13(B)(2)(d)((1)) of this Part, small quantity generators in the same building may share a common storage facility within the building (before the waste is transported off-site), without applying for a letter of authorization; provided that the appropriate logs are kept at both the original generation point and the central collection point, as described in § 1.13(E)(2) of this Part; and,

(5) Prior to utilization of a common storage facility pursuant to § 1.13(B) of this Part, all participating small quantity generators shall be signatories to a written agreement which describes, at a minimum, the person(s) responsible for preparing the medical waste tracking form, the person(s) responsible for arranging off-site transportation of regulated medical waste, and the person(s) assuming legal responsibility for any violation of these regulations. Notwithstanding the foregoing, any written agreement must be approved in advance by the Director if the average total regulated medical waste generated per month is in excess of two hundred (200) pounds; and,

(6) Other than small quantity generators may act as the manager/agent for agreements pursuant to §§ 1.13(B) through (C) of this Part provided that: they are located in the same building as the participants; all regulated medical waste received under the agreement is segregated from their own regulated waste; and all regulated medical waste received under the agreement is transported off-site under a separate medical waste tracking form; and,

(7) The regulated medical waste is transported by the generator, or an authorized employee, in a vehicle owned by the generator or authorized employee; and,

(8) The generator shall compile a shipment log and maintain records as required in § 1.13(E)(2) of this Part.

3. Shipments Between Generator’s Facilities: Generators are exempt from the requirement to use transporters that have a Rhode Island regulated medical waste transporter permit number when transporting regulated medical waste from the original generation point to a central collection point, or between satellite facilities, provided they meet all of the following conditions:

a. The regulated medical waste is transported by the generator, or the generator’s authorized employee, in a vehicle owned by the generator or the employee; and,

b. The regulated medical waste is brought to a central collection point or treatment facility owned or operated by the generator.

(1) Small quantity generators who transport regulated medical waste between satellite facilities shall apply for a letter of authorization from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908.

(2) Other generators (i.e., those who generate and transport or offer for transport more than fifty (50) pounds of regulated medical waste in a calendar month) with multiple locations shall apply for a transporter permit and letter of authorization as per § 1.14 of this Part from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908;

c. The original generation point and the central collection point or treatment facility are located in the State of Rhode Island; and,

d. The generator compiles and maintains a shipment log at each generation point and each central collection point as required by § 1.13(E) of this Part.

4. Shipments of Sharps and Unused Sharps through the U.S. Postal Service: small quantity generators who transport regulated medical waste (sharps and unused sharps) by the U.S. Postal Service are exempt from the requirement to use a transporter that has a Rhode Island regulated medical waste transporter permit number provided that the following conditions are met:

a. The package is sent by first class or priority mail in accordance with § 1.10(Q) of this Part (Infectious Substances) of the United States Postal Service Domestic Mail Manual.

b. The generator compiles a shipment log and maintains the original shipping papers as required by § 1.13(E) of this Part;

c. Reports shall be submitted to the Director for the periods of January 1 to June 30 and July 1 to December 31 of each year. These reports shall be received by the Director within forty-five (45) days of the end of each reporting period.

5. Transportation of sharps from residences by health care professionals: Health care professionals and veterinarians who generate medical waste that would otherwise be classified as household medical waste, may transport the waste back to their offices without a medical waste tracking form, provided the waste is properly packaged in accordance with § 1.7 of this Part and that the waste is properly handled as regulated medical waste upon arrival at the central collection point.

C. Use of the Tracking Form

1. Except as otherwise exempted in § 1.13(B) of this Part, a generator that transports or offers for transport regulated medical waste for off-site treatment or disposal shall prepare a tracking form according to this section.

2. Generators may obtain samples of the Rhode Island Medical Waste Tracking Form from: Rhode Island Department of Environmental Management, Office of Land Revitalization and Sustainable Materials Management, 235 Promenade Street, Providence, RI 02908.

3. The generator shall prepare the number of tracking form copies that will provide the generator, each transporter(s), and each intermediate handler with one copy, and the owner or operator of the destination facility with two copies.

4. The generator shall also:

a. Sign the certification statement on the tracking form by hand;

b. Obtain the signature of the initial transporter and include the date of acceptance on the tracking form; and,

c. Retain one copy, in accordance with § 1.13(E) of this Part.

5. For rail shipments of regulated medical waste within the United States that originate at the site of generation, the generator shall send at least three (3) copies of the tracking form dated and signed in accordance with § 1.13(C) of this Part to:

a. The next non-rail transporter, if any; or,

b. The intermediate handler or destination facility if transported solely by rail; or,

c. The last rail transporter to handle the waste in the United States if exported by rail.

D. Generators Exporting Regulated Medical Waste

Generators, including transporters and intermediate handlers that initiate tracking forms, which export regulated medical waste to a foreign country for treatment and destruction, or disposal, shall request the destination facility to provide written confirmation that the waste was received. If the generator does not receive written confirmation from the destination facility within forty-five (45) days from the date of acceptance of the waste by the first transporter, the generator shall submit an exception report as required under § 1.13(F) of this Part.

E. Recordkeeping

1. Except as provided in § 1.13(E)(2) of this Part, each generator shall:

a. Retain both the original generator receipt [yellow-copy, page 4] and the completed generator copy [white-copy, page 1] of each tracking form signed in accordance with § 1.13(C) of this Part, for at least three hundred and seventy-five (375) days from the date the waste was accepted by the initial transporter; and,

b. Retain for a period of three hundred and seventy-five (375) days a copy of all exception reports required to be submitted under § 1.13(F) of this Part.

2. Generators that are exempt from using the medical waste tracking form, as specified in § 1.13(B) of this Part, shall meet the following requirements:

a. A shipment log shall be maintained at the original generation point for a period of three hundred and seventy-five (375) days from the date the waste was shipped. The log shall contain the following information:

(1) Date of shipment;

(2) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(3) Address or location of central collection point;

(4) Signature of generator’s employee who is transporting the waste, to signify delivery has been completed.

b. A shipment log shall be maintained at each central collection point for a period of three hundred and seventy-five (375) days from the date that regulated medical waste was accepted from each original generation point and shall contain the following information:

(1) Date of receipt;

(2) Quantity (and unit of measure) of regulated medical waste accepted, by waste category (i.e., untreated and treated);

(3) Address or location of original generation point; and,

(4) Signature of generator or generator’s representative who operates the central collection point, to signify acceptance of the waste.

3. Generators that meet the conditions of § 1.13(B)(2) of this Part and do not voluntarily comply with the use of the medical waste tracking form are subject to the following recordkeeping requirements:

a. Generators that use a transporter that holds a valid Rhode Island regulated medical waste transporter permit shall maintain a log for a period of three hundred and seventy-five (375) days from the date of shipment that contains the following information for each shipment or pickup:

(1) Transporter’s name and address;

(2) Transporter’s regulated medical waste transporter permit number;

(3) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(4) Date of shipment; and,

(5) The signature of the transporter’s representative accepting the regulated medical waste for transport.

b. Generators who transport their own regulated medical waste to a treatment, destruction, or disposal facility as specified in § 1.13(B)(2)(d) of this Part shall compile and maintain a log for a period of three hundred and seventy-five (375) days from the date of the last shipment entered into the log. The log shall contain the following information:

(1) Name and address of the intermediate handler, destination facility, or health care facility to which the generator has transported the shipment of regulated medical waste;

(2) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(3) Date of shipment; and,

(4) Signature of the generator or his authorized representative who transported the waste.

c. Generators that transport regulated medical waste by the U.S. Postal Service § 1.13(B)(4) of this Part shall retain the original shipping papers and a shipment log for a period of three hundred and seventy-five (375) days from the date of shipment. The log shall contain the following information:

(1) Quantity and unit of measure of regulated medical waste transported, by waste category (i.e., untreated and treated);

(2) Date of shipment; and,

(3) Name and address of each intermediate handler or destination facility to which the generator has transported the regulated medical waste by the U.S. Postal Service.

F. Exception/Discrepancy Reporting

1. A generator that meets the conditions of § 1.13(B)(1) of this Part or initiates a tracking form voluntarily shall contact the owner or operator of the destination facility, transporter(s), and intermediate handler(s), as appropriate, to determine the status of any tracked waste if he does not receive a copy of the completed tracking form with the signature of the owner or operator of the destination facility within thirty-five (35) days of the date the waste was accepted by the initial transporter.

2. A generator shall submit an exception report, as described below, to the Director if he has not received a completed copy of the tracking form signed by the owner or operator of the destination facility within forty-five (45) days of the date the waste was accepted by the initial transporter. The exception report shall be postmarked on or before the forty-sixth (46th) day and shall include:

a. A legible copy of the original tracking form for which the generator does not have confirmation of delivery; and,

b. A cover letter signed by the generator or his authorized representative explaining the efforts taken to locate the regulated medical waste and the results of those efforts.

c. The generator shall keep a copy of the exception report for a period of at least three hundred and seventy-five (375) days from the due date of the report.

3. A generator shall also submit a discrepancy report, as described below, to the Director if there are any discrepancies between the information contained on the original generator receipt [yellow-copy, page 4] and the signed/completed generator copy [white-copy, page 1] that are not documented in block 23 of the medical waste tracking form. This discrepancy report shall be postmarked no later than five (5) working days from the date that the signed/completed generator copy [white-copy, page 1] is received from the owner or operator of the destination facility and shall include:

a. A legible copy of both the original generator receipt and the signed/ completed generator copy received from the owner or operator of the destination facility; and,

b. A cover letter signed by the generator or his authorized representative identifying the discrepancies that were not documented in block 23 of the medical waste tracking form;

c. The generator shall keep a copy of this discrepancy report for a period of at least three hundred and seventy-five (375) days from the date of the report.

South Carolina Medical Waste Regulations

Info for Infectious Waste Generators

Registration

Any facility that generates any infectious waste should register with the infectious waste program. Registration should include at least:

The name of the business

The name of the owner and responsible party (if different)

Physical location of the site (each site must apply separately)

Mailing address of site

Telephone number of site

Contact name

Categories and amount (in pounds) of waste generated annually.

If any of this information changes, the facility is to notify DHEC’s Infectious Waste Program within 30 days.

Registration must be renewed every 3 years.

Registration Form For Infectious Waste Generators

Attention

Infectious Waste Registrations and Renewals can now be completed online using ePermitting.  Please use the link below to complete a new registration or renew an existing registration.

https://epermweb.dhec.sc.gov/ncore/external/home

If you need assistance or have questions please email infectiouswaste@dhec.sc.gov.

Fees

The following fees will be due at time of registration and annually thereafter.

Small quantity generators (Less than 50 pounds of waste per calendar month) – no fee

Large quantity generators (50-999 pounds per calendar month) – $150

Extra-large quantity generators (1,000 or more pounds per calendar month) – $600

If in any calendar month a facility generates more than allowed under their current classification, their classification will change.

Online Invoice Payments . If you have a problem making an online payment, please call (803) 898-3460 .

Inspections

Infectious Waste inspections are random and unannounced.  The inspector views areas where infectious waste is being collected or stored.  The waste is viewed to determine proper packaging, proper labeling, and proper storage conditions.  Manifests, weight records (in pounds), and treatment method records will be reviewed for completeness and accuracy.  The inspector may also request to view any other physical areas or documents associated with the regulation. 

Package and Storage of Infectious Waste

How should infectious waste be packaged and stored?

Sharps must be placed in rigid, leak- and puncture-resistant containers secured tightly. All other waste should be stored and maintained in a rigid or semi-rigid leak-proof container that will not allow liquid in or out.

Containers must be strong enough to resist bursting and tearing during handling and transport and must be able to be closed tightly and securely.

Plastic bags used inside containers must be red or orange.

Reusable containers are acceptable but must be disinfected after each use.

Waste should not be compacted before or during storage or transport.

Waste storage begins when a container is closed.

While waste is being stored, it must be kept safe from insects and rodents, weather and leaking.

If the waste is stored outside, the storage area must be locked.

Access to storage areas must be limited to authorized personnel only.

Storage areas should be labeled with the biohazard symbol and the words INFECTIOUS WASTE (or BIOHAZARDOUS WASTE or MEDICAL WASTE).

Waste cannot be stored onsite for more than 14 days; if kept at or below 42° Fahrenheit, waste cannot be stored more than 30 days.

Waste should have no odor. If it begins to smell, it should be transported immediately.

Transport/Treatment of Waste

Rules:

Containers must be labeled properly before transport.

Labeling must be clearly visible and include:

Biohazard symbol

Infectious Waste Program Registration Number

Date the container was placed in storage or sent off-site

Words INFECTIOUS WASTE (or BIO-HAZARDOUS WASTE or MEDICAL WASTE).

Before waste can be transported, it must be manifested. This manifest must accompany waste at all times after leaving the generating facility. The manifest must include:

The generator’s name, address and infectious waste program registration number

A general description of the waste being shipped

The number of containers and the weight

The name of the treatment facility where the waste is going

Certification by the generator that the waste is packaged, described and labeled properly

Certification that the waste does not include hazardous or radioactive waste

The name of the transporter

The date the transporter picked up the waste

The date the treatment facility received the waste

Not all of this information will be available when the waste is picked up for transport, although the manifest should include all but the last items at pick-up. The fully completed manifest should be returned to the generator within 50 days of pick-up. If it is not returned within 50 days of pick-up, the generator should notify the infectious waste program.

How should infectious waste be packaged and stored?

Sharps must be placed in rigid, leak- and puncture-resistant containers secured tightly. All other waste should be stored and maintained in a rigid or semi-rigid leak-proof container.

Containers must be strong enough to resist bursting and tearing during handling and transport and must be able to be closed tightly and securely.

Plastic bags used inside containers must be red or orange.

Reusable containers are acceptable but must be disinfected after each use.

Waste should not be compacted before or during storage or transport.

Waste storage begins when a container is closed.

While waste is being stored, it must be kept safe from insects and rodents, weather and leaking.

If the waste is stored outside, the storage area must be locked.

Access to storage areas must be limited to authorized personnel only.

Storage areas should be labeled with the biohazard symbol and the words INFECTIOUS WASTE (or BIOHAZARDOUS WASTE or MEDICAL WASTE).

Waste cannot be stored onsite for more than 14 days; if kept at or below 42° Fahrenheit, waste cannot be stored more than 30 days.

Waste should have no odor. If it begins to smell, it should be transported immediately.

Transport/Treatment of Waste

Rules:

Containers must be labeled properly before transport.

Labeling must be clearly visible and include:

Biohazard symbol

Infectious Waste Program Registration Number

Date the container was placed in storage or sent off-site

Words INFECTIOUS WASTE (or BIO-HAZARDOUS WASTE or MEDICAL WASTE).

Before waste can be transported, it must be manifested. This manifest must accompany waste at all times after leaving the generating facility. The manifest must include:

The generator’s name, address and infectious waste program registration number

A general description of the waste being shipped

The number of containers and the weight

The name of the treatment facility where the waste is going

Certification by the generator that the waste is packaged, described and labeled properly

Certification that the waste does not include hazardous or radioactive waste

The name of the transporter

The date the transporter picked up the waste

The date the treatment facility received the waste

Not all of this information will be available when the waste is picked up for transport, although the manifest should include all but the last two at pick-up. The fully completed manifest should be returned to the generator within 50 days of pick-up. If it is not returned within 50 days of pick-up, the generator should notify the infectious waste program.

South Dakota Medical Waste Regulations

Managing Medical Waste

South Dakota’s solid waste administrative rules require that medical/infectious waste be rendered non-infectious prior to disposal in a municipal solid waste landfill.

Medical/Infectious Waste Defined

It is first important to understand what constitutes regulated medical/infectious waste. The Administrative Rules of South Dakota (ARSD) Section 74:27:07:01 adopt a medical/infectious waste definition found in the Code of Federal Regulations (40 CFR Part 60.51c). This lengthy definition broadly means any waste generated in the diagnosis, treatment, or immunization of human beings or animals, including related research, and production or testing of biologicals. Regulated medical/infectious waste is most commonly generated in hospitals, clinics, dentist offices, and veterinary facilities. It is important to recognize that the definition does not include certain hazardous wastes and medical-related wastes that are generated in our homes or a residential setting.

Treatment/Disinfection Required

The solid waste administrative rules (ARSD 74:27:13:17) require that medical/infectious waste must be rendered non-infectious by incineration, steam sterilization, chemical disinfectant, or equally effective treatment method, prior to disposal in a municipal solid waste landfill. A map of South Dakota landfills permitted to accept treated medical waste can be viewed on our Permitted Municipal Solid Waste Landfills webpage.

Tennessee Medical Waste Regulations

Medical waste, by definition at rule 0400-11-01-.01(2), is a “special waste” and must be managed as follows:

Untreated Medical Waste

Untreated medical waste requires special waste approval as set forth at rule 0400-11-01-.01(4). The Division believes that medical wastes can be landfilled without identifiable risk to public health or the environment if certain precautions are taken. In order to assure that this occurs, the practices listed below must be strictly followed.

Operating Restrictions – Medical wastes must be managed at the landfill in accordance with the following provisions:

1. Medical wastes must be transported to the landfill separately from other solid wastes and in securely tied plastic bags or other leak-proof containers. Sharps must be packaged in medical waste containers designed to prevent puncture. Cardboard boxes, garbage bags, and plastic beverage containers are not acceptable for this purpose.

2. The landfill operator must obtain advance notice prior to receiving a shipment of medical waste, or a routine delivery schedule must be established, such that the operator will have time to prepare to receive the waste.

3. The landfill operator must confine unloading and disposal operations to a specific area, separate from the normal working face.

4. Soil or an approved cover material must be placed on the medical waste prior to compaction.

5. Before the end of the operating day, there must be at least one foot of compacted soil or other approved cover material placed over all medical waste received that day.

It should also be noted that a special waste approval does not obligate the landfill operator to accept medical waste for disposal. The operator may refuse to accept such waste or impose additional conditions on the medical waste generator.

Treated (Rendered Non-Infectious) Medical Waste

Treated medical waste will not require individual special waste approval. The Division recommends that all medical wastes be incinerated, steam sterilized, or otherwise rendered noninfectious prior to disposal in Class I disposal facilities. It shall be the practice of the Division to consider treated (rendered non-infectious) medical waste as an approved special waste if the following conditions are met:

1. The waste is rendered non-infectious by sterilization techniques prior to disposal;

2. A written description of the treated medical waste must be provided to the disposal facility;

3. A written and signed verification must be provided to the disposal facility that the waste has been rendered non-infectious; and

4. All waste restrictions at rule 0400-11-01-.04(2)(k)4 are met. Sharps must be packaged in medical waste containers designed to prevent puncture. Cardboard boxes, garbage bags, and plastic beverage containers are not acceptable for this purpose.

If there is a change in either the medical waste description or the process that renders the medical waste non-infectious, a new waste description and verification must be submitted. These conditions may either be met by the medical waste generator or a commercial processing facility.

Texas Medical Waste Regulations

Requirements for Generators of Medical Waste

Generators of medical waste that ship their waste off-site for treatment are required to package and label it properly as specified in 30 TAC 326.17, 326.19, and 326.21 before its transportation off-site. The following options are available to comply with the container weight requirements.

Generators may record the weight or volume on the manifest for reporting and calculation of fees.

• If the generator chooses to use weight, the generator may have the transporter weigh each container for the generator and note the weight on the container label before transportation off-site, or

• Transporters must give the generator a written or electronic statement of total weight or volume of the containers collected within 45 days of shipment.

The TCEQ does not require the use of certified scales to weigh medical-waste containers. The accuracy of general-use scales is appropriate for the records that must be kept. Subsection 30 TAC 326.19(a) requires that the bags containing medical waste be placed in a rigid container that is leak resistant, impervious to moisture, strong enough to prevent tearing and bursting under normal use and handling, and sealed to prevent leakage or as otherwise required by the U.S. Department of Transportation under 49 CFR 173.134 and 49 CFR 173.196, which address infectious substances. To clarify, the TCEQ does not construe “impervious to moisture” to eliminate the use of cardboard boxes designed for medical waste, but intends to set a standard for medical-waste containers that do not conform to 49 CFR 173.134. Most commercially purchased cardboard containers for medical waste do meet the CFR requirements.

Generators are required to obtain a signed shipping receipt from a registered transporter, maintain records of all shipments of untreated medical waste sent offsite for three years after the date of shipment, and make the records available for inspection by the TCEQ. Generators should also obtain a receipt from the medicalwaste treatment facility certifying that the waste has been properly treated as required by 30 TAC 326.75(e)(7)(D) and must also maintain these records and make them available for TCEQ inspection upon request.

Generators that treat their own medical waste on-site are required to notify the TCEQ of the operation as specified in 30 TAC 326.39 and 326.41 and are also required to maintain records of the amount of each load of medical waste treated. All such generators must maintain records including the date of treatment, the amount of waste treated, and the name of the person performing the treatment. Generators of more than 50 pounds of medical waste per month—large-quantity generators (LQGs)—must also maintain records documenting the testing of microorganism-reduction performance or parameter monitoring of the treatment unit. Record-keeping requirements for LQGs are specified in 30 TAC 326.41(b).

Requirements for Transporters of Untreated Medical Waste

Generators of less than 50 pounds of medical waste per month (small-quantity generators) may transport their own untreated medical waste without being subject to the transporter requirements specified in 30 TAC 326.31(b).

LQGs and transporters of untreated medical waste who are not the generator of the waste may obtain a registration by rule as specified in 30 TAC 326.53 only after they supply the TCEQ with the information required by the rule. The agency also requires transporters to pay an annual registration fee to maintain their authorization to transport.

Transporters are required to use transport units that meet the requirements of 30 TAC 326.53(b)(6). As required by 326.53(b)(6)(A), the cargo compartment must have a floor and sides made of an impervious, nonporous material in order to allow disinfection of the surfaces of the cargo area should containers leak or if the unit will be used to transport other items as specified in 30 TAC 326.53(b)(7).

For putrescible or biohazardous untreated medical waste, maintaining a temperature of 45 degrees Fahrenheit or less during pre-collection storage is optional. (Pre-collection storage is storage by the generator, normally on the generator’s premises, before initial collection.) Such medical waste in more than 72 hours post-collection storage must be maintained at 45 degrees Fahrenheit or lower. There are two types of post-collection storage as defined under 30 TAC 326.3(53). Post-collection storage by a transporter occurs while the medical waste is in transit. Post-collection storage by a processor occurs at a processing facility while the waste is awaiting processing or transfer to another storage, disposal, or recovery facility.

Transporters, like generators, are required to maintain records of all shipments of untreated medical waste for the most recent three years and must make the records available to the TCEQ for inspection as specified in 30 TAC 326.53(b)(8).

Transporters may only transfer loads of untreated medical waste at an authorized facility unless a transportation unit malfunctions or is involved in a traffic accident. If a vehicle breakdown or accident occurs, a transporter may transfer the load to an operational transportation unit but must notify the TCEQ by the end of the next working day if there is an accident and within five working days if there is a vehicle malfunction, as specified in 30 TAC 326.53(b)(18) and (19). Update to the transporter’s registration by rule is required when the new unit or units are placed in medical-waste transport service for more than five days.

Transporters of waste within Texas when the transportation neither originates nor terminates in Texas must follow 30 TAC 326.53(b)(16).

Transporters must summarize, in a report to the TCEQ, all their activities for the preceding calendar year. The report must be submitted no later than March 1 of the following year. The report must contain all the information specified in 30 TAC 326.89(d).

Requirements for Operators of MSW Type V Medical-Waste Treatment Facilities

Operators of medical-waste treatment facilities are required to obtain a registration, rather than a permit to operate the facility, as specified in 30 TAC 326.61(a).

Operators of treatment facilities must maintain records of all treated waste similar to the records required of operators of mobile treatment units. The required records are specified in 30 TAC 326.71(j) and include either microorganismreduction performance testing or parameter monitoring. If chemicals or reagents are used in treatment, the operator must also maintain records of the effective treatment strength of all reagents and chemicals. All documents must be maintained for three years.

Operators of treatment facilities shall only accept waste that is accompanied by a shipping document that indicates their facility as the receiving facility as specified in 30 TAC 326.75(e)(7). The operator is also required to sign the shipping document, give a copy of the document to the transporter, retain a copy for the facility records, and within 45 days send a copy of the document to the generator of the waste including a statement that the medical waste has been treated using an approved method as specified in 25 TAC 1.136.

Utah Medical Waste Regulations

LARGE HEALTH FACILITIES

The Utah Infectious Waste Requirements apply to health facilities that generate more than 200 pounds of infectious waste per month. However, several local health departments have rules that differ in some ways from the state requirements. Please contact your local health department for their specific requirements for the management of infectious waste. Following is a general summary of the state requirements for the management of infectious waste regulated by Rule R315-316. A health facility that generates more than 200 pounds of infectious waste per month must:

– Prepare, maintain on file, and follow an infectious waste management plan and otherwise meet the requirements of the OSHA Bloodborne Pathogen Standard.

– Except for sharps, isolate infectious waste in secured plastic bags or rigid containers. The containers must be red or orange or, if not red or orange, clearly identified with the international biohazard sign and label “INFECTIOUS WASTE,” “BIOMEDICAL WASTE,” or “BIOHAZARD.”

– Isolate sharps in leak-proof, rigid, puncture-resistant containers. The containers must be red or orange or, if not red or orange, clearly identified with the international biohazard sign and label “INFECTIOUS WASTE,” “BIOMEDICAL WASTE,” or “BIOHAZARD.”

– If storage is necessary, protect infectious waste from the elements in a storage area that is ventilated to the outside and accessible only to authorized persons. The storage area must be marked with prominent warning signs. If infectious waste is to be stored longer than seven days, it must be stored at or below 40 Fahrenheit (5 Celsius).

INFECTIOUS WASTE TRANSPORTATION

Transporters of infectious waste are regulated when they have more than 200 pounds from one source in the vehicle at one time. Transporters must:

– Transport infectious waste separate from other waste unless the waste is contained in a separate, fully enclosed leak-proof container within the vehicle compartment or unless all of the waste in the vehicle is to be treated as infectious waste. Vehicles transporting infectious waste must meet all requirements of the Department of Transportation.

– Transport infectious waste using equipment that will contain all waste so that there are no releases of infectious waste to the environment and follow USDOT requirements.

– Provide training for drivers in waste handling and spill cleanup methods.

– Label vehicles by DOT standards.

– Have spill kit available.

– Clean all surfaces of transport vehicles when spills have occurred.

– Store waste no longer than 7 days without refrigeration and no longer than 60 day total.

INFECTIOUS WASTE TREATMENT AND DISPOSAL

Infectious waste is to be treated or disposed as soon as possible but not to exceed 60 days after collection from a generator. The waste is to be treated or disposed at a facility with a permit or other form of approval allowing the facility to treat or dispose of infectious waste. Following are the treatment or disposal methods that are allowed.

– Infectious waste may be incinerated in an incinerator that has a permit or other approval from both the Division of Solid and Hazardous Waste and the Division of Air Quality (see UAC R315-316-5(3)).

– Infectious waste may be sterilized by heating in a steam sterilizer to render the waste noninfectious. After sterilization, the waste may be managed as a noninfectious solid waste (See UAC R315-316-5(4)).

– Other methods may be used to render infectious waste noninfectious. Prior to its use, any other method must be approved, on a site-specific basis, by the Director of the Utah Division of Solid and Hazardous Waste. After being rendered noninfectious, the waste may be managed as a noninfectious solid waste (See UAC R315-316-5(5)).

– Liquid or semisolid infectious waste may be discharged to a sewage treatment system that provides secondary treatment of waste, if approved by the operator of the sewage treatment system (See UAC R315-316-5(6)).

– Infectious waste may be disposed in a permitted Class I, II, or V Landfill. Upon entering the landfill, the vehicle operator must declare that the load contains infectious waste and must follow any procedures required by the landfill operator (See UAC R315-316-5(7)).

– The Division suggests that landfill operators contact waste haulers and facilities that may generate infectious waste within the facility service area to work out the safest and most efficient method of handling and disposing of infectious waste.

SMALL HEALTH FACILITIES AND SMALL QUANTITY TRANSPORTERS

Small health facilities (small clinics, doctors’ offices, dentist offices, veterinary offices, etc.) that generate 200 pounds, or less, of infectious waste per month and transporters that transport 200 pounds or less from any one facility per load are not regulated by the Utah Infectious Waste Rules. However, several local health departments have requirements that apply to health facilities that generate lower amounts of infectious waste and transporters that transport smaller amounts of infectious waste. Please contact your local health department for requirements that may be different from the state rule.

OSHA and USDOT have separate regulations apply to infectious waste. These regulations should be consulted by persons handling infectious waste. Although not require by rule, small health facilities and transporters of small amounts of infectious waste may wish to provide the maximum protection for the facility employees and employees of the waste transportation and disposal facilities by following the standards for large facilities or transporters. Also, any of the above listed methods of treatment and disposal, applicable to the waste type, may be used. Waste collection vehicles that may collect some infectious waste as part of residential or commercial collection services are assumed to be transporting less than 200 pounds of infectious waste per load.

Virginia Medical Waste Regulations

Management of Regulated Medical Waste

The Virginia Regulated Medical Waste Management Regulations establish standards and procedures for the management of all RMW including proper packaging, labeling, storage, transport, transfer, treatment, and disposal.

Prior to storage, treatment or transport, all regulated medical waste must be properly packaged and labeled in accordance with the VA RMW Management Regulations. Appropriate personal protective equipment must be worn when packaging RMW.

Regulated medical waste shall be placed in containers meeting the requirements of the Bloodborne Pathogen Standard. Red biohazard bags shall be used for the packaging of all RMW, except for sharps. Sharps (including veterinary sharps), such as needles, syringes with attached needles, suture needles, and scalpels, must be placed directly into puncture resistant sharps containers.

All RMW packaging must be closed and sealed to prevent leaks and spills during handling and is required to be labeled. The label shall be securely attached to or printed on packaging. The label may be a tag securely affixed to the package. Indelible ink shall be used to complete the information on the label.

The label and the information provided on the label must be clearly legible. The following information shall be included:

The name, address and business telephone number of the generator.

“Regulated Medical Waste” in large print.

The Biological Hazard Symbol.

Prior to transporting regulated medical waste, waste shall be packaged for transportation in accordance with the standards of 49 CFR Part 173 or packaged in accordance with an exemption approved by the United States Department of Transportation.

Facilities that generate RMW but do not treat RMW on-site, nor transfer or consolidate RMW from other sites, are not required to obtain a permit from DEQ as long as RMW is temporarily stored in accordance with the applicable storage requirements of the VA RMW Management Regulations summarized below:

RMW shall be properly packaged, labeled and sealed such that no waste materials can leak.

Appropriate personal protective equipment (PPE) must be worn when packaging RMW.

No more than 200 gallons total of RMW may be held on-site at any one time.

All RMW shall be held in a safe and secure manner ensuring that waste cannot spill, or contact workers or the general public.

No more than 25 percent of the RMW can be generated from off-site.

RMW may not be treated on-site.

Records of RMW disposal are recommended (but not required) to be maintained.

The generator must comply with the requirements for temporary storage of RMW on loading docks or in loading areas (see section below).

Facilities that generate RMW but do not treat RMW on-site, nor transfer or consolidate RMW from other sites, are not required to obtain a permit from DEQ as long as RMW is temporarily stored in accordance with the applicable storage requirements of the VA RMW Management Regulations summarized below:

RMW shall be properly packaged, labeled, and sealed such that no waste materials can leak.

RMW shall be stored in a designated storage area, on floors or surfaces that are clean and impermeable to liquids (i.e. no carpets, cracks or gaps).

RMW storage areas shall have access controls, such as locked doors, to limit access only to individuals specifically designated to manage RMW.

RMW may only be stored up to seven days without refrigeration, and up to a maximum of 15 days. The storage start date shall be indicated on the RMW outer packaging.

Floor drains in RMW storage areas must discharge directly to the sanitary sewer, and ventilation shall discharge to minimize human exposure to the effluent. RMW shall be stored under cover and protected from the elements, and over a floor or bermed pavement that will contain leaks and spills.

Reusable RMW containers, if used, should be cleaned with detergent or general purpose disinfectant after each use.

Appropriate PPE must be worn when handling containers of RMW.

No more than 25 percent of the RMW can be generated from off-site.

RMW may not be treated on-site.

Records must be maintained of all RMW received from off-site, the generator, amount and its storage and receipt dates. Other required records include a contact list for the infection control committee members, an RMW spill log, facility RMW policies and procedures, and an RMW training log. Records must be maintained for at least three years.

The generator must comply with the requirements for temporary storage of RMW on loading docks or in loading areas.

Transport and Transfer Requirements

Transporters of RMW are subject to all transportation requirements of the U.S. Department of Transportation’s Hazardous Materials Regulations (49 CFR Parts 171 through 180) as well as the Special Requirements for Transportation in Part VI (9VAC20-120-400 through 9VAC20-120-500) of the VA RMW Management Regulations.

RMW Transporters are not required to register with DEQ or obtain a permit from DEQ as long as the transporter is not operating as a Transfer Station or Treatment Facility.

RMW Transfer Stations are facilities that collect, consolidate, or store regulated medical waste generated from off-site prior to transportation to another facility for further processing, treatment, transfer, or disposal. Any vehicle containing RMW that is parked 24 hours or more during transport is considered an RMW Transfer Station.

RMW Transfer Stations are required to obtain a permit from DEQ and are subject to additional operational and recordkeeping requirements in accordance with the VA RMW Management Regulations.

Treatment and Disposal Requirements

Prior to disposal, all regulated medical waste must be properly treated at a permitted RMW Treatment Facility using steam sterilization (autoclaving), incineration, or an approved alternative treatment method.

RMW Treatment Facilities are required to obtain a permit from DEQ and are subject to additional operational and recordkeeping requirements in accordance with the VA RMW Management Regulations.

Waste that has been properly treated at a permitted RMW Treatment Facility in accordance with the requirements of the VA RMW Management Regulations is considered a solid waste that can then be disposed of at a permitted solid waste management facility (e.g. sanitary landfill), provided the facility’s permit allows for acceptance of the material.

Vermont Medical Waste Regulations

RMW Handling, Treatment, and Disposal

(a) Any person who generates RMW should complete the requirements of the Procedure for Waste Minimization and Pollution Prevention Assessment. These assessment materials should be maintained by the generator and available for reference and review by staff.

(b) Any person who generates, treats, transports, transfers, or disposes of RMW must comply with the applicable section as identified in the following table:

(c) RMW Packaging Requirements: Generators must comply with all U.S. Department of Transportation packaging regulations, 49 CFR 173.197 and OSHA regulations, 29 CFR 1910.1030.

(d) RMW Storage Requirements: Persons who store RMW must comply with the following requirements:

(1) Waste received at a treatment or transfer facility must be date stamped or otherwise electronically identified as received as it is inventoried into the facility as soon as feasible, not to exceed eight hours.

(2) The date of the first waste added will be visible on the containers. Containers will be considered in storage conditions after 30 days from the first waste added.

(3) Waste must be stored under cover on an impervious surface in a manner and location that maintains the integrity of the packaging and prevents contact with water, precipitation, wind, and animals.

(4) Storage areas dedicated to RMW must be secured to prevent unauthorized access.

(5) Access to on-site storage areas must be limited to authorized personnel.

(6) Areas used for the storage of RMW must be labeled with the universal warning sign or word to identify a “Universal Biohazard”.

(7) Treated and non-treated RMW must be maintained in a non-putrescent state such that there are no offsite odors.

(8) Time limits for storage of untreated RMW, not including sharps, at a generator that serves as a consolidating point, transfer facility, or treatment facility may not exceed:

Storage Conditions From Date of receipt

Room Temperature up to 3 days

Refrigerated at < 40 F up to 7 days

Frozen at < 0 F up to 37 days

(e) RMW Treatment Requirements

(1) Persons that treat RMW must meet the following criteria:

(A) Waste received at a treatment facility must be date stamped or otherwise electronically identified as received as it is inventoried into the facility as soon as feasible, not to exceed eight hours.

(B) RMW must be treated by the following methods prior to disposal:

(i) Pathological waste shall be incinerated at either a certified RMW treatment facility or at a crematorium; and

(ii) All other RMW shall be autoclaved or treated by an alternative treatment management method in accordance with an agreement for the proper disposal of the treated RMW at a certified disposal facility which has been approved by the Secretary.

(iii) Exceptions:

(I) Cultures and stocks must be treated in accordance with the requirements of 29 CFR §1910.1030;

(II) Blood and liquid wastes may be treated in a municipal wastewater treatment facility with the municipality’s approval;

(III) Unused sharps in original packaging do not require treatment but may be disposed of as treated RMW. Once unused sharps are removed from the original packaging, they are considered RMW; and

(IV) All trace chemotherapy waste shall be incinerated or chemically neutralized.

(iv) Treatment effectiveness must be demonstrated by one of the following methods:

(I) Manufacturer accepted maintenance and validation testing; or

(II) Other method with prior approval by the Secretary.

(2) A Certification of Treatment (see Appendix), or a written alternative treatment management method approval, must accompany all treated waste offered for disposal and must provide the following information:

(1) Date treated;

(2) Name and address of treatment facility;

(3) Contact person;

(4) Method of treatment;

(5) Signature of operator or duly authorized person, certifying waste was treated to meet the manufacturer accepted decontamination; and

(6) Method used to render waste inaccessible, if applicable.

(3) Used sharps should be placed in a container specifically manufactured for sharps with a secure top.

(1) For containers that come specifically with an immobilizing agent, follow the instructions to add the agent, wait the prescribed time to activate, then dispose of in the municipal solid waste.

(2) If container does not come with an immobilizing agent, follow the guidance provided by the EPA titled: Community Options for Safe Needle Disposal, or as may be amended.

(3) The container should be closed securely with the screw cap or use strong tape, like duct tape, along the edges to prevent containers from opening.

(4) All general medical waste should be placed in a separate container and disposed of in the municipal solid waste.

(5) Potentially infectious bodily fluids should be contained with an absorbent material prior to disposal in the municipal solid waste.

(6) Alternative Treatment Management Method Approval: All alternative treatment management methods must meet the manufacturer accepted decontamination and be approved by the Secretary.

RMW Transport Requirements

(1) Haulers of RMW must have a solid waste commercial hauler permit under the provisions of 10 V.S.A. §6607(a) and in accordance to Occupational Safety and Health Administration (OSHA) regulations, 29 CFR 1910.1030 and US Department of Transportation regulations, 49 CFR 173.197.

(2) Haulers of treated RMW must have a Certificate of Treatment or a written alternative treatment management method approval in the vehicle during transportation.

(3) Haulers shall not accept boxes which show evidence of leaking.

(4) Haulers must complete delivery from a generator to a transfer facility, treatment facility or disposal facility within 72 hours or the next business day, whichever is later.

(g) RMW Disposal Requirements

(1) Once RMW has been decontaminated, the treated RMW may be disposed of at a certified solid waste landfill.

(2) Treated sharps rendered inaccessible may be mixed in with municipal solid waste.

(3) A Certification of Treatment or a written alternative treatment management method approval:

(1) Must accompany all treated waste offered for disposal.

(2) Shall be maintained by all in-state landfills for a period of one year.

Section 4 RMW Generators with On-site Treatment and/or Serving as Consolidation Points

(a) Applicability Requirements:

(1) Generators, except for facilities working with infectious agents at biosafety levels 3 or 4, may treat RMW on-site of the facility if the approved treatment equipment is available and the facility has been approved to treat RMW.

(2) All facilities may not treat pharmaceuticals as part of the on-site treatment and must follow reverse distribution and other alternatives outlined in the EPA Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities.

(3) The facility is required to have a RMW operational plan submitted for review and approval. The type of sanitization treatment methodology, such as autoclaving, will be explained in detail in the RMW operational plan.

(b) Generators with onsite treatment or that serve as consolidation points shall maintain and complete the following documentation and reporting requirements:

(1) The large quantity generator will notify the Secretary when the agreement with the associate small quantity generators is established and will track all incoming waste.

(2) The large quantity generator will have a written agreement with the small quantity generators on file at the facility.

(3) In the case where the large quantity generator is in litigation, all records must be maintained throughout the litigation process.

(c) Small quantity generators that are participating in the large quantity generator on-site treatment and consolidation shall:

(1) Be subject to all packaging labeling, hauling, and recordkeeping requirements. Generators must comply with all U.S. Department of Transportation packaging regulations, 49 CFR 173.197 and OSHA regulations, 29 CFR 1910.1030.

(2) Be prohibited from shipping infectious agents at biosafety levels 3 or 4 to the consolidation and treatment facility.

RMW Transfer Facility Certification

(a) Application Requirements: The complete application for a RMW transfer facility or facility component must address requirements of the Solid Waste Management Rules. Additional information required within an application for a RMW transfer facility must include within the Facility Management Plan (FMP), at a minimum, the following:

(1) Listing of the sources and quantities of RMW anticipated;

(2) Detailed description of the facility operations including:

(A) Unloading, weighing, monitoring, handling and storing practices;

(B) Methods to control contaminants potentially released into the air, soil or water;

(C) A prevention plan for the separation and proper management of hazardous waste and other prohibited materials;

(D) An agreement with a treatment facility to accept the RMW;

(E) A schedule for transfer of the RMW to a treatment facility adjusted as necessary to minimize odors from the waste;

(F) A prevention plan for detecting and managing radioactive wastes;

(G) A plan for educating generators and haulers regarding the type of RMW that is acceptable for storage and transfer at the facility;

(H) Engineering plans and specifications including: site plans showing the property boundaries, facility building dimensions, and waste storage area(s); and

(I) Other information deemed necessary by the Secretary to adequately review the application and protect public health and safety and the environment.

RMW Treatment Facility Certification

(a) Application Requirements: The complete application for a RMW treatment facility must address the Solid Waste Management Rules. Additional information required within an application for a RMW treatment facility includes:

(1) A FMP which includes, at a minimum, the following:

(A) Listing of all treatment component(s) including:

(i) Detailed description of how each component operates;

(ii) Demonstration that the RMW, when treated, meets the manufacturer accepted decontamination; and

(iii) Appropriate operating parameters for the process, such as residence time, temperature, pressure, irradiation levels, and chemical concentrations.

(B) Listing of the sources and quantities of RMW anticipated;

(C) Detailed description of the facility operations including:

(i) Process flow diagram showing all aspects of RMW waste handling from receiving through offering for disposal including, but not limited to, unloading, weighing, monitoring, storing and treatment;

(ii) Start-up and, shut-down procedures;

(iii) Disinfection processes for reusable containers;

(iv) Facility hours of operation; and

(v) Methods to control the release of contaminants into the air, soil or water.

(vi) Facility must conform and comply with local wastewater discharge or publicly owned treatment works requirements and obtain wastewater and stormwater permits as necessary;

(vii) List and description of all permits required including any required for air and water discharges;

(viii) Description of the hauling process into and out of the facility;

(ix) Prevention plan for the separation and proper management of hazardous waste and other prohibited materials;

(x) Prevention plan for detecting and managing radioactive wastes;

(xi) Plan for educating generators, venders and haulers regarding the type of RMW that is acceptable for treatment at the facility;

(D) Engineering plans and specifications including:

(i) Site plans showing the property boundaries, facility building dimensions, site topography, utilities, treatment unit(s) and layout;

(ii) Piping diagrams and connection details;

(iii) Cross-section views of the facility; and

(iv) Additional specifications for all equipment instrumentation and control centers;

(E) Description of the calibration and validation of component used to achieve treatment including:

(i) Manufacturer accepted indicator used with each load to verify the effectiveness of a specific RMW treatment device, and

(ii) Monthly manufacturer specified calibration and validation completed during standard operation conditions.

(F) Monitoring and maintenance plan for all treatment, pollution control and detection equipment;

(G) Agreement for the proper disposal of the treated RMW at a certified disposal facility; and

(H) Any other information deemed necessary by the Secretary to adequately review the application.

(b) RMW is accompanied by a certification of treatment or written alternative treatment management method approval, may be disposed of at a certified municipal solid waste landfill disposal facility.

Washington Medical Waste Regulations

Washing State biomedical waste is regulated at the county level – check with your local county concerning biomedical waste collection, handling, storage, and treatment regulations.

BIOMEDICAL WASTE

A. Biomedical Waste. “Biomedical waste” means and is limited to the following types of waste defined as “Biomedical waste” in RCW 70.95K.010, as amended:

 1. “Animal waste” is waste animal carcasses, body parts, and bedding of animals that are known to be infected with, or that have been inoculated with, human pathogenic microorganisms infectious to humans.

 2. “Biosafety level 4 disease waste” is waste contaminated with blood, excretions, exudates, or secretions from humans or animals who are isolated to protect others from highly communicable infectious diseases that are identified as pathogenic organisms assigned to biosafety level 4 by the Centers for Disease Control, National Institute of Health, Biosafety in Microbiological and Biomedical Laboratories, current edition.

 3. “Cultures and stocks” are wastes infectious to humans and includes specimen cultures, cultures and stocks of etiologic agents, wastes from production of biologicals and serums, discarded live and attenuated vaccines, and laboratory waste that has come into contact with cultures and stocks of etiologic agents or blood specimens. Such waste includes but is not limited to culture dishes, blood specimen tubes, and devices used to transfer, inoculate, and mix cultures.

 4. “Human blood and blood products” is discarded waste human blood and blood components, and materials containing free-flowing blood and blood products.

 5. “Pathological waste” is waste human source biopsy materials, tissues, and anatomical parts that emanate from surgery, obstetrical procedures, and autopsy. “Pathological waste” does not include teeth, human corpses, remains, and anatomical parts that are intended for interment or cremation.

 6. “Sharps waste” is all hypodermic needles, syringes with needles attached, IV tubing with needles attached, scalpel blades, and lancets that have been removed from the original sterile package.

B. Biomedical Waste Collection/Transportation Vehicle. “Biomedical waste collection/transportation vehicle” means a collection/transportation vehicle used for the collection and transportation of biomedical waste over the highways.

C. Biomedical Waste Generator. “Biomedical waste generator” means any producer of biomedical waste to include without limitation the following categories: general acute care hospitals, skilled nursing facility or convalescent hospitals, intermediate care facilities, in-patient care facilities for the developmentally disabled, chronic dialysis clinics, community clinics, health maintenance organizations, surgical clinics, urgent care clinics, acute psychiatric hospitals, laboratories, medical buildings, physicians’ offices and clinics, veterinary offices and clinics, dental offices and clinics, funeral homes, or other similar facilities. “Biomedical waste generator” does not include residences that generate waste from occupants’ self-treatment. Home-generated syringe wastes are excluded from this category if the containment and disposal requirements specified in Section 10.07.060 B.11.c of this title are followed.

D. Biomedical Waste Storage/Treatment Operator. “Biomedical waste storage/treatment operator” means a person who treats and/or stores biomedical waste and is not a biomedical waste generator.

E. Biomedical Waste Storage/Treatment Site. “Biomedical waste storage/treatment site” means a location where biomedical waste is stored for more than fifteen (15) days or treated by a person who is not a biomedical waste generator. Sites such as incinerators, steam sterilizers and other approved facilities will be considered biomedical waste storage/treatment sites.

F. Biomedical Waste Transporter. “Biomedical waste transporter” means a person who transports biomedical waste over public roads commercially or one who transports in volumes that equal or exceed one hundred (100) pounds per month.

G. Biomedical Waste Treatment. “Biomedical waste treatment” means biomedical waste treated by processes described in 10.07.060 C of this title or by a method approved in writing by the health officer.

H. Steam Sterilization. “Steam sterilization” means sterilizing biomedical waste by use of saturated steam within a pressure vessel at temperatures sufficient to kill all microbiological agents in the waste as determined by biological and chemical indicator monitoring requirements set forth in this title. (R&R No. 03-06 § 2 (part), 11-21-2003).

10.07.020 Permitting. It shall be unlawful for any person to operate a biomedical waste storage/treatment site or operate as a biomedical waste transporter without a valid permit issued by the health officer. Permits shall not be transferable and shall be valid only for the person and place or vehicle for which issued. Owners and operators of biomedical waste facilities shall comply with the permitting and other requirements of WAC 173-350-490. (R&R No. 03-06 § 2 (part), 11-21-2003).

10.07.030 Biomedical waste vehicle permitting. Any person intending to operate as a biomedical waste transporter shall submit two (2) copies of a written application to the health officer, on a form to be obtained from the health officer. Such application shall include the applicant’s full name, post office address, and the name and signature of an authorized representative of the applicant; shall disclose whether such applicant is an individual, firm, corporation or partnership, and, if a partnership, the names and mailing addresses of all of the partners; and the address and type of the respective biomedical waste collection/transportation vehicle; and shall be accompanied by the permit fee amount described in Section 2.14.010 of this code. The biomedical waste transporter permit application shall also state the legal description of the site(s) that the applicant is planning to use to treat biomedical waste, and have a contingency plan as described in Section 10.07.060 C.4 of this code. (R&R No. 05-05 § 135, 6- 17-2005: R&R No. 03-06 § 2 (part), 11-21-2003).

10.07.040 Requirements related to transport of biomedical waste. Biomedical waste shall be transported over public roads only in a leakproof and fully enclosed container or vehicle compartment. Biomedical waste shall not be transported in the same vehicle with other waste or medical specimens unless the biomedical waste is contained in a separate, fully enclosed leakproof container within the vehicle compartment. Biomedical waste shall be delivered for treatment only to a facility that meets all local, state and federal environmental regulations, as determined by the appropriate local, state and federal agencies. The transporter shall keep records of disposal for a period of at least three (3) years, and they shall be available to the health officer upon request. Surfaces of biomedical waste collection/transportation vehicles that have contacted spilled or leaked biomedical waste shall be decontaminated as described in this title. (R&R No. 03-06 § 2 (part), 11-21-2003).

10.07.050 Requirements for biomedical waste vehicles. Biomedical waste collection/transportation vehicles used by permitted biomedical waste transporters shall have a leakproof fully enclosed vehicle compartment of a durable and easily cleanable construction, and shall be identified on each side of the vehicle with the name or trademark of the biomedical waste transporter. Vehicles shall be cleaned frequently to prevent rodent/vector and odor nuisances. In addition, the health officer may require disinfection of any vehicle. All wastewater from vehicle cleaning shall be disposed of in a sanitary sewer system unless otherwise authorized by the health officer. (R&R No. 03-06 § 2 (part), 11- 21-2003).

10.07.060 Biomedical waste.

A. Biomedical Waste Management Plan. Each biomedical waste generator (BWG) and biomedical waste storage/treatment operator (BWSTO) must write a biomedical waste management plan with an internal annual review. The plan shall include all aspects of the BWG’s or BWSTO’s biomedical waste management. The plan must be followed by the BWG or BWSTO. The plan must include a listing of the BWG’S or BWSTO’s infection control staff/committee member(s); phone numbers of responsible individuals; definition of wastes handled by the system; department and individual responsibilities; procedures for waste identification, segregation, containment, transport, treatment, treatment monitoring, disposal, contingency planning, staff/house-keeping training for biomedical waste identification, as applicable, and compliance with biomedical waste regulations. The plan must include the chief executive officer’s endorsement letter. The plan shall be available for inspection at the request of the health officer.

B. Storage and Containment of Biomedical Waste.

 1. Storage of biomedical waste shall be in a manner and location which affords protection from animals, rain and wind; does not provide a breeding place or a food source for insects or rodents; and is accessible only to personnel authorized in the biomedical waste generator’s biomedical waste management plan.

 2. Biomedical waste shall be segregated from other waste by separate containment from other waste at the point of origin.

 3. Biomedical waste, except for sharps, shall be contained in disposable leakproof plastic bags having a strength to prevent ripping, tearing, breaking or bursting under normal conditions of use. The plastic bags shall be appropriately marked by the generator as containing biomedical waste. The plastic bags shall be secured to prevent leakage or expulsion during storage. Note: This shall not apply to biomedical waste stored in rigid plastic, single-use or approved multiple-use marked containers.

 4. Sharps shall be contained in leakproof, rigid, puncture resistant, break resistant containers which are labeled and tightly lidded during storage, handling and transport.

 5. Biomedical waste held in plastic bags as described in subsection B.3 of this section shall be placed in other leakproof containers such as disposable or reusable pails, drums, or bins for storage, handling or transport. The containers shall be conspicuously labeled with the international biohazard symbol, and the words “Biomedical Waste” or other words that clearly denote the presence of biomedical waste.

 6. Reusable containers:

 a. Reusable containers for biomedical waste storage, handling or transport shall be thoroughly washed and decontaminated by an approved method each time they are emptied unless the surfaces of the containers have been protected from contamination by disposable liners, bags or other devices removed with the waste, separate from those required in subsection B. 3 of this section.

 b. Approved methods of decontamination are agitation to remove visible solid residue combined with one of the following procedures:

 i. Chemical Disinfection. Chemical disinfectants should be used in accordance with the manufacturer’s recommendations for tuberculocidal and viricidal (Polio type 1 or 2, SA Rotovirus) killing capacities or by disinfectant concentration/contact times approved in writing by the health officer.

 ii. Other method approved in writing by the health officer.

 c. Reusable pails, drums or bins used for containment of biomedical waste shall not be used for any other purpose except after being disinfected by procedures as described in this paragraph and after the international biohazard symbol and words “Biomedical Waste” are removed.

 7. Trash chutes shall not be used to transfer biomedical waste.

 8. Unless approved in writing by the health officer, biomedical waste, other than sharps, shall be treated in accordance with subsection C of this section or delivered to a biomedical waste storage/treatment operator within fourteen (14) days from the generation of the waste. Sharps waste must be disposed in accordance with Section 10.07.060 B.11 or be transported to a storage/treatment facility within ninety (90) days commencing from the time the sharps container is sealed.

 9. Biomedical waste shall not be subject to compaction prior to treatment.

 10. Biomedical waste shall not be placed into the general solid waste stream prior to treatment.

 11. At no time shall treated sharps waste, except incinerated sharps waste, be disposed into the general solid waste stream, unless approved in writing by the health officer.

 a. Treated sharps waste, except incinerated sharps waste, shall be segregated from the general solid waste stream in approved sharps containers for disposal at a medical waste treatment facility or landfill approved by the health officer. Treated sharps waste shall not be mixed with the general solid waste stream at any time.

 b. The transporter of treated sharps waste, excluding incinerated sharps waste, must notify the disposal site operator prior to transporting the sharps waste to allow for adequate site preparation and staff availability. The sharps waste shall be covered with at least six inches (6”) of compacted waste material within twenty-four (24) hours of disposal.

 c. Home-generated sharps are exempt from other provisions of Section 10.07.060 if prepared for disposal by a means that protects medical handlers, solid waste workers and the public from injury.

The disposal of home generated sharps shall be limited to:

 i. Depositing sharps at a medical facility which has agreed to accept home-generated sharps;

 ii. Depositing properly contained sharps at a pharmacy that provides a program to dispose sharps waste that meets the requirements of these regulations;

 iii. Acquiring a pickup service from a biomedical waste transporter permitted by the health officer;

 iv. Outside the City of Seattle: Depositing the sharps in the regular household garbage, provided that they are contained in a manner that protects solid waste workers and the public. Such containment shall be limited to the following:

 (A) Needle clippers approved by the health officer. Such devices shall clip the needle from the syringe directly into a crush-proof container and render the syringe barrel harmless, or

 (B) Two (2) liter clear P.E.T. plastic bottles commonly used for soft drink containers. Such bottles shall be tightly capped and taped to further secure the cap to the bottle. The bottle must be labeled/marked “Warning: Syringes, Do Not Recycle.”;

 v. Within the City of Seattle: The Seattle Municipal Code governs the disposal of homegenerated sharps as solid waste.

 vi. Other methods approved by the health officer.

C. Biomedical Waste Treatment.

 1. Biomedical waste shall be treated prior to disposal by one or more of the following methods:

 a. Cultures and stocks of etiologic agents and associated biologicals: steam sterilization, incineration or other treatment method approved in writing by the health officer;

 b. Biomedical waste: steam sterilization, incineration or other treatment method approved in writing by the health officer;

 c. Sharps: incineration, containment as described in this title or other treatment method approved in writing by the health officer;

 d. Pathological waste: incineration, interment or other treatment method approved in writing by the health officer. Tissue of 0.5 centimeters or less in diameter may be disposed into an approved sewer system with the approval of the local sewer authority;

 e. Human body fluids shall be considered treated biomedical waste when they are:

 i. Poured directly into an approved sanitary sewer system;

 ii. Incinerated; or

 iii. Absorbed by materials such as bandages, sanitary napkins or commercial absorbents so that the fluid will not be released from the material and/or become airborne during normal solid waste handling practices;

 f. Wastes that have come into contact with human body fluids from patients diagnosed with pathogenic organisms assigned to Biosafety Level 4: steam sterilization, incineration or other treatment method approved in writing by the health officer;

 g. Animal waste exposed to pathogens in research: incineration or other treatment method approved in writing by the health officer.

 2. Biomedical waste treatment and disposal shall be conducted as follows:

 a. Steam Sterilization. Steam sterilization by heating in a steam sterilizer so as to kill all microbiological agents as determined by chemical and biological indicator monitoring requirements set forth in this section. Operating procedures for steam sterilizers shall include, but not be limited to, the following:

 i. Adoption of standard written operating procedures for each steam sterilizer, including time, temperature, pressure, type of waste, type of container(s), closure on container(s), pattern of loading, water content and maximum load quantity;

 ii. Check of recording and/or indicating thermometers during each complete cycle to ensure the attainment of a minimum temperature of two hundred fifty degrees Fahrenheit (250° F) or one hundred twenty-one degrees centigrade (120° C) for one-half (1/2) hour or longer, depending on quantity and compaction of the load, in order to achieve sterilization of the entire load. Thermometers shall be checked for calibration at least annually;

 iii. Use of heat-sensitive tape or other device for each load that is processed to indicate that the load has undergone the steam sterilization process;

 iv. Use of the chemical migrating integrator Thermalog-S, or other chemical integrator meeting equivalent time, temperature and steam indicator specifications, based upon Bacillus stearothermophilus spore kill steam sterilization parameters, approved in writing by the health officer. The chemical integrator shall be placed at the center load of each cycle to confirm attainment of adequate sterilization conditions for each biomedical waste treatment cycle run;

 v. Use of the biological indicator, Bacillus stearothermophilus, or other biological indicator approved in writing by the health officer, placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

 vi. Maintenance of records of procedures specified in paragraphs i, ii, iii, iv and v of this subsection for a period of not less than three (3) years;

 vii. Development and implementation of a written steam sterilization training program for steam sterilizer operators. Biomedical waste so treated shall be disposable into the general solid waste stream provided it is not otherwise hazardous waste or nonincinerated sharps waste.

 b. Incineration. Incineration shall be conducted at a sufficient temperature and for sufficient duration that all combustible material is reduced to ash; that no unburned combustible material is evident in the ash. Operating procedures for incinerators shall include, but not be limited to, the following:

 i. Adoption of a standard written operating procedure for each incinerator that takes into account: variation in waste composition, waste feed rate and combustion temperature;

 ii. Development and implementation of a written incinerator operator training program for incinerator operators;

 iii. Implementation of a program to test incinerator ash for extractable heavy metals prior to disposal at a licensed disposal site. Should the incinerator ash fail the Toxicity Characteristics Leaching Procedure (TCLP) analysis for heavy metals, the ash must be handled as a State Dangerous Waste under WAC Chapter 173-303;

 iv. Records of generator, quantities and destruction shall be maintained by the incinerator owner/operator for a period of not less than three (3) years.

 c. Interment. Interment of pathological waste shall be conducted in such a manner so as to meet all federal, state and local regulations.

 3. Biomedical waste treated in accordance with this section, with the exception of nonincinerated sharps waste, shall be considered solid waste and may be disposable into the general solid waste stream.

 4. Contingency planning. Each biomedical waste generator and biomedical waste storage/treatment operator must have an alternative plan for the treatment of biomedical waste to be used in the event that changes at the primary treatment facility result in that facility no longer conforming to the requirements of this code.

D. Biomedical Waste Storage/Treatment Site Requirements. Biomedical waste storage areas must comply with the following requirements:

 1. Unless otherwise approved by the health officer, the biomedical waste storage area must be located on the same site as the treatment facility.

 2. The storage area shall be kept locked and accessible only to authorized personnel at all times.

 3. The storage area shall be conspicuously marked with a sign twelve inches by twelve inches (12” x 12”) with the words “Biomedical Waste” and the international biohazard symbol.

 4. The storage area shall be constructed of cleanable materials and kept in a sanitary condition.

A spill kit must be available at the site.

 5. The waste shall be stored in a nonputrescent state using refrigeration when necessary.

 6. The total combined time biomedical waste can be stored with the biomedical waste transporter and the storage/treatment site, prior to disposal, shall be fifteen (15) days unless otherwise approved by the health officer.

E. Transfer of Biomedical Waste. Any biomedical waste generator who produces more than one hundred (100) pounds of biomedical waste per month that requires off-site biomedical waste treatment shall have the waste transported only by a biomedical waste transporter.

F. Inspection. The health officer shall have the authority to inspect any biomedical waste generator (BWG) or biomedical waste storage/treatment operator (BWSTO), at any reasonable time, for the purpose of evaluating the BWG’s or BWSTO’s written biomedical waste management plan, to determine if the BWG’s or BWSTO’s biomedical waste is being handled, stored, treated and disposed in accordance with this regulation. The health officer shall have the authority to inspect any biomedical waste transporter at any reasonable time, for the purpose of determining if the provisions of this title are being met. (R&R No. 03-06 § 2 (part), 11-21-2003).

Wisconsin Medical Waste Regulations

Infectious Waste Management

NR 526.05 Infectious waste categories.

(1) A solid waste which is included in any of the following categories is presumed to be infectious waste unless methods of testing which are generally accepted by the medical profession demonstrate that the waste is not infectious:

(a) Sharps, as follows:

1. Contaminated sharps which are both infectious and may easily cause punctures or cuts in the skin, including but not limited to: hypodermic needles, syringes with needles attached, scalpel blades, lancets, broken glass vials, broken rigid plastic vials and laboratory slides.

2. Unused or disinfected sharps which are being discarded, including hypodermic needles, scalpel blades, lancets and syringes with needles attached.

(b) Bulk blood and body fluids from humans.

(c) Human tissue.

Note: A tooth containing mercury amalgam may be both an infectious waste and a hazardous waste. See s. NR 526.11 (2) (f) for how to manage teeth containing mercury amalgam.

(d) Microbiological laboratory waste.

(e) Tissue, bulk blood or body fluids from an animal which is carrying a zoonotic infectious agent.

(2) A solid waste which is not included in the definition of infectious waste, which is not mixed with infectious waste and which does not fall under one of the categories in sub. (1) is presumed not to be an infectious waste. Solid wastes presumed not to be infectious wastes include all of the following:

(a) Items soiled but not saturated with blood or body fluids from humans included in the definition of “bulk blood and body fluids”.

(b) Items soiled with body fluids from humans not included in the definition of “bulk blood and body fluids”.

(c) Intravenous tubing after needles have been detached.

(d) Tissue, blood, body fluids or cultures from an animal which is not known to be carrying or experimentally infected with a zoonotic infectious agent.

(e) Animal manure and bedding.

(f) Other solid wastes, including but not limited to containers, packages, waste glass, laboratory equipment and other materials which have had no contact with blood, body fluids, clinical cultures or infectious agents. When possible, use of these items shall be reduced, and the items shall be reused or recycled.

(g) Formerly infectious waste, after it has been treated according to s. NR 526.11.

(3) An item which is trace chemotherapy waste and is also considered to be infectious waste either by being included in the definition of infectious waste or by falling under one of the categories in sub. (1), is regulated only according to s. NR 526.055. However, if that item is mixed with bulk amounts of chemotherapy waste which is a hazardous waste, the item is regulated according to chs. NR 660 to 670.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; cr. (2) (g), Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: am. (3) Register January 2006 No. 601, eff. 2-1-06; correction in (3) made under s. 13.93 (2m) (b) 7., Stats., Register April 2013 No. 688.

NR 526.055 Trace chemotherapy waste.

(1)  Source separation.

(a) No person may mix trace chemotherapy waste in the same bag or waste receptacle with infectious waste or with non-hazardous solid waste, unless mixing the wastes is necessary to protect the health or safety of patients, employees or other persons.

(b) If infectious waste or non-hazardous solid waste is mixed with trace chemotherapy waste, the mixture shall be managed according to subs. (2) and (3).

(c) If trace chemotherapy waste is mixed with other chemotherapy waste, the mixture shall be managed according to chs. NR 660 to 670.

(2) Containment. No person may transport trace chemotherapy waste from the property where the waste was generated unless the person puts the waste in a container which protects waste handlers and other persons from exposure to the trace chemotherapy waste and all of the following requirements are met:

(a) Hard trace chemotherapy waste, including but not limited to syringes, drug dispensing devices and broken or empty chemotherapy drug vials, shall be contained in rigid, puncture-resistant labeled plastic containers designed to prevent the loss of the contents and labeled with the visible words “Trace chemotherapy waste” and “Incinerate only”.

(b) Soft chemotherapy waste, including but not limited to gloves, disposable gowns, towels, empty intravenous solution bags and empty tubing, may be contained in containers meeting the requirements of par. (a) or in a bag meeting the requirements of s. NR 526.07 (2) (a) and (b).

Note: “Empty” has the meaning in s. NR 661.07.

(3) Treatment. Trace chemotherapy waste shall be treated by incineration or other method approved by the department. An incinerator used to treat trace chemotherapy waste may be one of the following:

(a) An incinerator regulated by the department under s. NR 502.09 or 502.13 or regulated by another state as an incinerator that burns medical waste.

(b) An incinerator regulated by the department under chs. NR 664 and 665 or regulated by another state as an incinerator that burns hazardous waste.

Note: The NIOSH “Hazardous Drug Alert” lists hazardous drugs, including chemotherapy drugs, by name and gives guidance on containment, labeling, handling, storage and disposal.

History: CR 05-020: cr. Register January 2006 No. 601, eff. 2-1-05; correction in (1) (c), (3) (b) made under s. 13.93 (2m) (b) 7., Stats., Register April 2013 No. 688.

NR 526.06 Source separation.

(1) No person may mix infectious waste in the same bag or waste receptacle with solid waste which is not infectious waste, unless mixing the wastes is necessary to protect the health or safety of patients, employees or other persons.

(2) No person may separate infectious waste from solid waste which is not infectious waste unless adequate measures are taken to protect waste handlers and other persons from exposure. After separation, solid waste previously mixed in the same bag or waste receptacle with infectious waste shall be managed as infectious waste.

(3) No person may remove solid waste or infectious waste that has been placed in a bag or waste container labeled with the biohazard symbol or fail to manage the waste as infectious waste from the time of generation until the waste has been treated according to s. NR 526.11, unless the person follows waste management procedures which will protect waste handlers and other persons from exposure.

(4) No person may transport solid waste and infectious waste on the same cart or vehicle unless the wastes are in separate and identifiable bags or waste containers. If the wastes are transported on any roads, the requirements of ss. NR 502.06 and 526.10 shall also be met.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94.

NR 526.07 Containment. No person may transport infectious waste from the property where the waste was generated unless the person puts the waste in a container which protects waste handlers and other persons from exposure to the infectious waste and the person meets all of the following requirements:

(1) Sharps shall be contained in rigid, puncture-resistant labeled containers made of materials including but not limited to metal or rigid plastic, designed to prevent the loss of the contents and labeled with a visible bio- hazard emblem or with the visible words “bio-hazard”, “sharps” or “infectious waste”.

(2) Infectious waste other than sharps shall be contained according to all of the following:

(a) The waste shall be placed in a single plastic bag that meets or exceeds 165 grams resistance by the ASTM method D1709-04 and is tear resistant using method ASTM method D1922-03a, or, if necessary, a double bag that meets the same standards, or a rigid reusable container.

Note: These testing methods are entitled “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method” and “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” respectively. Copies are available for inspection at the central office of the department of natural resources and the offices of the secretary of state and the legislative reference bureau. Copies may be obtained from ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA, www.astm.org, phone number 610-832-9585.

(b) The bag or rigid reusable container shall be securely sealed to prevent leakage or expulsion of the contents under normal handling.

(c) Any bag containing infectious waste shall be placed in a rigid container, including but not limited to a corrugated cardboard container, a covered reusable container or a covered cart. The rigid container shall be labeled with a visible bio-hazard emblem and the word “bio-hazard”. Bulk containers shall be small enough to be handled by a single person.

(3) No person may open a secured container of infectious waste which is ready for transportation until immediately before treating the waste, unless repacking is necessary to prevent spills or leakage, or the person is conducting a waste audit or training session.

(4) All reusable containers shall be disinfected after being emptied. No person may open, empty or clean a reusable sharps container by hand.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (intro.), Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: am. (2) (a) and (c), r. (2) (d), cr. (4) Register January 2006 No. 601, eff. 2-1-06.

NR 526.08 Handling. No person may handle, load, unload, process or treat infectious wastes unless adequate measures are taken to protect waste handlers and other persons from exposure to the infectious wastes and unless all of the following requirements are met:

(1) All containers shall be handled and transported to prevent the loss or spilling of the contents.

(2) Nuisance conditions shall be prevented from developing. Appropriate measures shall be taken to prevent odors, including but not limited to refrigerating the infectious waste below 42° Fahrenheit until treated.

(3) All infectious waste shall be loaded and unloaded by hand or by a safe mechanical method which does not damage containers or spill their contents.

(4) Untreated infectious waste may not be compacted.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (2), Register, June, 1996, No. 486, eff. 7-1-96.

NR 526.09 Storage and transfer. No person may store infectious wastes unless the person protects waste handlers and other persons from exposure to the infectious waste and unless the requirements of this section are met. For the purposes of this chapter, storage also includes, but is not limited to the transfer of infectious waste. Infectious waste generators may temporarily accumulate infectious waste in individual containers near the place where the waste was generated, prior to moving the waste to an on-site infectious waste storage facility.

(1) Licensing. Except as provided in sub. (2), no person may operate or maintain an infectious waste storage facility unless the person has obtained an operating license for storing solid waste under s. NR 502.05 and the storage facility meets all the requirements for handling infectious waste under s. NR 526.08 and storing infectious waste under this section. The department may require that the owner or operator provide proof of financial responsibility for the removal, transportation, treatment and ultimate disposal of the stored material. To apply for an operating license for an infectious waste storage facility, the applicant shall take all of the following actions:

(a) Contact the department to arrange an initial inspection.

(b) Prepare a plan of operation according to sub. (3).

(c) Submit the plan of operation to the department for approval, according to the requirements in s. NR 500.05. Upon receipt of the plan of operation, the department will send an invoice for the plan review fee for infectious waste storage facilities, as specified in s. NR 520.04, Table 2.

(d) After obtaining a plan of operation approval from the department, submit an application form for the operating license and the license fee, according to ss. NR 500.06 and 520.04, Table 2.

(2) Exemptions. Infectious waste storage facilities which meet any of the following conditions are exempt from the requirement to obtain an operating license under sub. (1) and preparing a plan of operation under sub. (3) for storing infectious waste, but shall meet the minimum operating requirements for storing infectious waste under sub. (4).

(a) Storage facilities which are located on the property where the infectious waste is generated.

(b) Storage facilities which are located on the property where the infectious waste is generated and which accept infectious waste from off-site generators, if the total quantity of infectious waste, including items mixed with infectious waste, accepted from off-site is less than the quantity generated on- site or less than 500 pounds per month, whichever is less and if the waste is accepted on a not-for-profit and cost-only basis.

(c) Sharps collection stations which comply with all of the requirements under sub. (5).

(d) Storage facilities for infectious waste which also is hazardous waste under s. 291.01 (7), Stats., provided that the storage facility is regulated under ch. NR 664.

(3) Plan of operation. No person may establish or construct an infectious waste storage facility or expand an existing facility unless the person has obtained a plan of operation approval from the department or unless the facility is exempt from licensing under sub. (2). The plan of operation shall specify the intent and objectives of the proposal and indicate methods and procedures to prevent and minimize adverse environmental and health impacts. Unless otherwise approved by the department in writing, the plan shall be submitted in accordance with s. NR 500.05 and shall contain, at a minimum, the information listed in s. NR 502.05 (8), except s. NR 502.05 (8) (e), and any other details necessary to address the requirements in this chapter, including but not limited to requirements for handling and containment and the requirements of sub. (4).

(4) Minimum requirements for all persons storing infectious waste. No person may operate or maintain an infectious waste storage facility unless the storage area meets all of the following requirements:

(a) The storage area shall be kept clean and be impermeable to liquids. Carpeted areas or wooden floors may not be used in storage areas.

(b) The storage area designated for infectious waste may contain only infectious wastes and their containers. The storage area may be an area designated within a room.

(c) The storage area shall be in an enclosed building, container or vehicle so that the infectious waste is not exposed to weather.

(d) Access to the storage area shall be limited to authorized personnel.

(e) Nuisance conditions shall be prevented from developing. Appropriate measures shall be taken to prevent odors, including but not limited to refrigerating the infectious waste below 42° Fahrenheit until treated.

(f) If the infectious waste is to be treated off-site, the operator of the infectious waste storage facility shall relinquish the infectious waste only to an infectious waste transporter licensed by the department or to a person exempt from licensing under s. NR 526.10 (2).

(g) The containers of infectious waste shall be removed and emptied as necessary, but at least every 90 days.

(h) The operator of the infectious waste storage facility shall keep records of how much and where the infectious waste has been sent off-site. Records may consist of any of the following: copies of infectious waste manifests, invoices, logs or other written documentation of the amount of infectious waste sent off-site for treatment.

(5) Operating requirements for sharps collection stations. No person may operate or maintain a sharps collection station unless the person complies with all of the following requirements:

(a) The person accepts only sharps and sharps containers from infectious waste generators, each of which generates less than 50 pounds of sharps per month, including items which may be mixed with the sharps.

(b) The person provides the service on a not-for-profit and cost-only basis.

(c) The person stores no more than 500 pounds of infectious waste in the sharps collection station at any one time.

(d) The person complies with the requirements in ss. NR 526.06 to 526.08526.09 (4) (a) to (g)526.10 (3) and 526.13.

(e) The person registers the sharps collection station with the department by mailing or delivering a letter of registration to the chief of the solid waste management section, bureau of solid and hazardous waste management, department of natural resources, P.O. Box 7921, 101 S. Webster Street, Madison, Wisconsin 53707-7921. The person shall also send copies of the letter to the appropriate department district and area offices. The letter of registration shall state all of the following:

1. Name, street address, county and phone number, if any, of the place where the sharps collection station is located.

2. Name, mailing address and phone number of person responsible for operating the sharps collection station.

3. Name, mailing address and phone number of the owner of the sharps collection station, if different than the operator.

4. Fees charged for use of the sharps collection station and what costs the fees cover.

(f) The person notifies the department immediately in writing if the sharps collection station moves or ceases to operate.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (1) (c), (d), (3), (4) (e), (5) (e) 1., r. (5) (e) 4., renum. (5) (e) 5. to be (5) (e) 4., Register, June, 1996, No. 486, eff. 7-1-96; correction in (5) (d) made under s. 13.93 (2m) (b) 7., Stats., Register March 2003 No. 567; correction in (2) (d) made under s. 13.93 (2m) (b) 7., Stats., Register April 2013 No. 688.

NR 526.10 Transportation and shipping. No person may transport or ship infectious waste in Wisconsin unless adequate measures are taken to protect waste handlers, the public and the environment from exposure to the infectious waste, and all of the following requirements are met:

(1) Licenses. Except as provided in sub. (2), no person may transport infectious waste or operate or maintain an infectious waste transportation service unless the person has obtained an infectious waste transportation license from the department for each vehicle and complies with both the minimum transportation requirements in sub. (3) and the operating requirements for licensed infectious waste transporters in sub. (4). To apply for an operating license, the applicant shall submit an application form and the infectious waste transportation license fee according to s. NR 520.04, Table 2.

(2) Exemptions. Persons who meet any of the following conditions are exempt from licensing under this section, but shall meet the minimum requirements for transporting infectious waste in sub. (3):

(a) Persons transporting infectious waste only on private roads on the same property where the infectious waste was generated and using vehicles or covered carts owned or leased by the infectious waste generator.

(am) Persons transporting infectious waste only on private roads between the property where the infectious waste was generated and a contiguous property, and using vehicles or covered carts owned or leased by either the infectious waste generator and the owner of the contiguous property.

(b) Persons transporting less than 50 pounds of infectious waste per calendar month.

(c) Persons operating vehicles owned or leased by the United States postal service and handling infectious waste sent through the mail.

(d) Persons operating vehicles owned by a parcel carrier service for which infectious waste constitutes an incidental portion of the carrier’s business, if the infectious waste is handled in accordance with all applicable state and federal regulations.

(e) Persons transporting infectious waste through Wisconsin who are not stopping to collect, drop off or transfer the infectious waste, and who handle the infectious waste in accordance with all applicable state and federal regulations.

(f) Persons transporting infectious waste which is also a hazardous waste under s. 291.01 (7), Stats., provided that the transportation is regulated under s. 291.23, Stats., and ch. NR 663.

(3) Minimum requirements for all persons transporting infectious waste. No person may transport infectious waste unless the person complies with all of the following minimum requirements:

(a) The infectious waste shall be contained according to the requirements of s. NR 526.07.

(b) The infectious waste shall be handled according to the requirements of s. NR 526.08.

(c) The vehicle used to transport the infectious waste shall meet all of the following requirements:

1. The portion of the vehicle where the infectious waste is contained shall be completely enclosed to prevent littering, spillage or leakage. The enclosed portion shall be leak-resistant, if necessary, considering the type of waste and its moisture content. Roll-off boxes or dumpsters may not be used to transport infectious waste.

2. The vehicle shall be maintained in good repair.

3. The vehicle shall be cleaned as frequently as necessary to prevent nuisances.

4. Nuisance conditions shall be prevented from developing. Appropriate measures shall be taken to prevent odors, including but not limited to refrigerating the infectious waste below 42° Fahrenheit until treated.

(d) The person shall transport the infectious waste only to solid waste facilities which are one of the following:

1. Licensed by the department to store or treat infectious waste.

2. Exempt from licensing by the department under the storage requirements in s. NR 526.09 (2) or under the treatment facility requirements in s. NR 526.12 (2) or are exempt from manifesting requirements under s. NR 526.14 (2), such as a registered sharps collection station.

Note: Other transportation regulations, such as USDOT standards, may also apply. For more information, contact USDOT helpline at 1-800-467-4922.

3. Facilities licensed or exempt by another state to store, incinerate or treat infectious waste.

(4) Operating requirements for licensed infectious waste transporters. Infectious waste transporters which are required to be licensed by the department shall comply with all the following requirements in addition to those in sub. (3):

(a) Each vehicle shall have “WDNR” followed by the infectious waste transportation license number lettered on the driver’s and passenger’s doors. The letters shall be at least 2 inches high with a minimum of 1/2 inch brush stroke. The lettering shall contrast with the background so it is easy to read.

(b) Vehicles or containers used for the collection or transportation of infectious waste shall be durable and easy to clean.

(c) Each vehicle hauling infectious waste shall carry a written contingency plan for spills and accidents and shall carry tools and materials sufficient to implement the contingency plan. In case of spill or accident, the driver shall implement the contingency plan immediately after spillage occurs and follow the provisions of s. 292.11, Stats.

(d) The portion of the vehicle where the infectious waste is placed shall be cleaned and disinfected before hauling materials other than infectious waste, solid waste or supplies related to managing waste.

(e) The person transporting the infectious waste shall sign all manifests which accompany the infectious waste, even if the waste is exempt from manifesting under s. NR 526.14 (2), and deliver the manifests to the next person who handles the waste.

(f) If infectious waste is not accompanied by an infectious waste manifest, the person transporting the waste shall initiate an infectious waste manifest for that waste, unless the person transporting the waste hauls less than 50 pounds of unmanifested infectious waste per month.

(5) Changes in service. Licensed infectious waste transporters shall notify the department in writing of all significant changes in service. The written notice shall be given to the department’s area or district office at least 30 days prior to the effective date of the change. If the change was not anticipated, the written notice shall be sent within 30 days after the change first occurred. Changes in service to individual clients or in the routes driven are not significant changes in service. All of the following actions are “significant changes in service”:

(a) Adding a vehicle.

(b) Replacing a vehicle.

(c) Changing the destination to which the infectious waste is hauled.

(d) Expanding the service area into another county.

(e) Terminating service.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94, am. (1), (3) (c) 4., Register, June, 1996, No. 486, eff. 7-1-96; correction in (2) (f) made under s. 13.93 (2m) (b) 7., Stats., Register April 2013 No. 688.

NR 526.11 Treatment methods. Except as provided in s. NR 526.04, no person may dispose of infectious waste in a solid waste disposal facility unless the infectious waste has undergone treatment in accordance with this section. The treatment method shall effectively render the waste non-infectious. The treatment method shall be chosen by considering the properties of the waste being treated and the degree of microbial contamination.

Note: The treatment method may also need to comply with air standards for control of hazardous pollutants in ch. NR 445 and with state or federal regulations for wastewater and occupational health and safety.

(1) Methods. Except as provided in s. NR 526.04, all infectious waste shall be treated by one or more of the following infectious waste treatment methods:

(a) Incineration. Treatment by incineration shall consist of incineration in a controlled air, multi-chambered incinerator which provides complete combustion of the waste to carbonized or mineralized ash. The incinerator shall be one that is regulated by the department under s. NR 502.09 or 502.13.

(b) Steam disinfection. Treatment by steam disinfection, including but not limited to autoclaving, shall subject all the waste to a combination of operational temperature, pressure (if applicable) and time proven to render the waste non-infectious at the design capacity of the installed equipment.

(c) Chemical disinfection. Treatment by chemical disinfection shall expose the infectious waste to an appropriate type and concentration of disinfectant for a period of time sufficient to render the waste non-infectious. The chemical disinfectant shall be chosen based on the manufacturer’s recommended use of the disinfectant, the cleanliness of the surface of the waste, the contact time, the physical and chemical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination.

(d) Mechanical grinding and chemical disinfection. Treatment by mechanical grinding and chemical disinfection shall expose all of the waste to the chemical disinfectant for a period of time sufficient to render the waste non-infectious. The chemical disinfectant shall be chosen based on the use of the disinfectant in medical situations, the cleanliness of the surface of the waste, the contact time, the physical and chemical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination. Treatment by mechanical grinding and chemical disinfection shall prevent the release of infectious liquid or infectious gaseous discharges into the environment.

(e) Mechanical grinding and heat disinfection. Treatment by mechanical grinding and heat disinfection, including but not limited to low frequency wave radiation and microwave radiation, shall expose all of the waste to heat for a period of time sufficient to render the waste non-infectious. Treatment by mechanical grinding and heat disinfection shall prevent the release of infectious liquid or infectious gaseous discharges into the environment.

(f) Gas disinfection. Treatment by gas disinfection shall allow gas to penetrate all the infectious waste and shall render the waste non-infectious. The unit shall be operated in a manner that does not pose an occupational risk of exposure to the gas.

Note: For ethylene oxide sterilizers, refer to OSHA regulations in 29 CFR 1910.1047. Air toxic rules in ch. NR 445 may also apply.

(g) Other methods. Treatment by other treatment methods and processes shall render the waste non-infectious and shall be appropriate with respect to all of the following: the properties of the waste being disinfected, the manufacturer’s recommended use of the disinfectant, the cleanliness of the surface of the waste, the contact time, the physical properties of the waste, the concentration of the disinfectant and the degree of microbial contamination.

(2) Special considerations. No person may treat the following categories of infectious waste except as follows:

(a) Human tissue. Human tissue, except teeth containing mercury amalgam treated according to par. (f), shall be treated by any of the following methods:

1. Methods which render the tissue both non-infectious and unrecognizable as human tissue.

2. Incineration where the tissue is transformed into an ash which would not be recognized as being from a human being.

(b) Animal tissue. Animal tissue known to be carrying or experimentally infected with a zoonotic infectious agent shall be treated by any of the following methods:

1. Methods which render the tissue non-infectious.

2. Incineration.

3. Burial on the land on which the animal was kept, in accordance with s. 289.43 (9), Stats., for animals infected with scrapie or s. 289.43 (8), Stats., or s. NR 503.08 for other animals.

4. Rendering or other methods which incorporate the animal into a consumer product in accordance with all other applicable state and federal regulations.

Note: For animals and animal waste used in HIV and HbV research, refer to OSHA blood-borne pathogen standard 29 CFR 1910.1030 (e).

(c) Sharps. Sharps shall be treated by any of the following methods:

1. A method which both renders the sharp non-infectious and renders the sharp broken and not able to be reused, such as by a grinding or shredding process.

2. Incineration.

(d) Bulk blood. Bulk blood shall be treated by any of the following methods:

1. Biological treatment in a municipal or industrial wastewater treatment facility which has been approved under s. 281.41, Stats., or permitted under ch. 283, Stats. Bulk blood may be transported to the wastewater treatment facility through the sewer system.

2. Methods which render the blood non-infectious.

3. Incineration.

(e) Body fluids and blood-contaminated urine and feces. Body fluids and blood-contaminated urine and feces shall be treated by any of the methods listed in par. (d) or by disposal in a septic system.

(f) Teeth containing mercury amalgam. Infectious waste generators shall disinfect a tooth containing mercury amalgam using procedures allowed under sub. (1) (c), except bleach, which leaches mercury, and shall manage the disinfected tooth in one of the following ways:

1. Recycle the disinfected tooth containing mercury amalgam with other mercury-containing wastes.

2. Dispose of the disinfected tooth containing mercury amalgam as a hazardous waste.

3. Remove the mercury amalgam from the disinfected tooth and either recycle the mercury amalgam or dispose of the mercury amalgam as a hazardous waste. The disinfected tooth may be discarded as solid waste.

Note: See the American Dental Association’s website at www.ada.org for recommended procedures for disinfecting teeth containing mercury amalgam.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (1) (a), (2) (b) 3., (e), Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: am. (2) (a) (intro.), cr. (2) (f) Register January 2006 No. 601, eff. 2-1-06.

NR 526.12 Treatment facilities.

(1)  Licenses. Except as provided in sub. (2), no person may operate or maintain an infectious waste treatment facility unless the person has obtained an operating license from the department under s. NR 502.08 as a solid waste processing facility and the facility meets all the requirements in this chapter for containing, handling, storing and treating infectious waste. To apply for an operating license, the applicant shall do all of the following:

(a) Contact the department’s district or area office as appropriate to arrange an initial site inspection for the purpose of evaluating compliance with the requirements of s. NR 502.08 (3).

(b) Prepare a plan of operation as described in sub. (3).

(c) Submit the plan of operation to the department for approval, according to the requirements in s. NR 500.05. Upon receipt of the plan of operation, the department shall send an invoice for the plan review fee for solid waste processing facilities, as specified in s. NR 520.04, Table 2.

(d) After obtaining a plan of operation approval from the department, submit an application form for the operating license and the license fee for a solid waste processing facility, according to ss. NR 500.06 and 520.04, Table 2.

(2) Exemptions. Persons who operate the following infectious waste treatment facilities are exempt from the requirements for obtaining an operating license and submitting a plan of operation for a solid waste processing facility, but shall comply with the following specified requirements:

(a) Individual infectious waste treatment facilities which are located on the property where the infectious waste was generated and which treat less than 500 pounds of infectious waste per day. These treatment facilities may accept infectious waste from other infectious waste generators if the waste is accepted on a not-for-profit and cost-only basis. Persons operating these infectious waste treatment facilities shall follow all the requirements in sub. (4) for operating and testing the treatment unit and for keeping records.

(b) Incinerators and municipal solid waste combustors, which are regulated under s. NR 502.09 or 502.13. In addition to what is required under those sections, persons operating incinerators and municipal solid waste combustors shall follow the requirements in sub. (4) (a) and (c) for operating an infectious waste treatment unit and for keeping records.

(3) Plan of operation. Except as provided in sub. (2), no person may establish or construct an infectious waste treatment facility or expand an existing facility unless the person has met the applicable requirements of s. NR 502.08 for solid waste processing facilities and has obtained from the department a plan of operation approval and applied for an operating license as a solid waste processing facility. The plan of operation shall specify the intent and objectives of the proposal and indicate methods and procedures to prevent and minimize adverse environmental and health impacts. Unless otherwise approved by the department in writing, the plan shall be submitted in accordance with s. NR 500.05 and shall contain, at a minimum, the information listed in s. NR 502.08 (3) to (5) and any other details necessary to address the requirements in this chapter, including but not limited to requirements for handling, containment and storage and the requirements in subs. (4) and (5).

(4) Minimum requirements for all treatment facilities. No person may operate or maintain an infectious waste treatment facility unless all of the following requirements are met:

(a) Operating. The person shall demonstrate that the treatment unit renders infectious waste non-infectious. The operator shall follow a written operational manual or documented quality assurance procedures for operating the treatment unit. The operational procedures shall be available to the operator at all times the treatment unit is in operation.

(b) Testing. At a minimum, the person shall ensure that a qualified person tests the treatment unit at the frequency specified by the manufacturer’s instructions or after every 100 hours of operation, whichever is more frequent. Test methods shall be appropriate for the treatment method and shall be based on medically-accepted procedures and the manufacturer’s instructions. Acceptable test methods may be physical, chemical or microbiological in nature, as appropriate for the treatment method.

(c) Keeping records. The person shall maintain an operating log for each treatment unit in the treatment facility and retain the operating log for at least 3 years. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action. For treatment units treating 50 pounds or more of infectious waste per month, the operating log shall be kept for all test cycles and treatment cycles. For treatment units treating less than 50 pounds of infectious waste per month, the operating log shall be kept for test cycles only. The operating log shall contain all of the following information for all test cycles and, if required, treatment cycles:

1. Date.

2. Clock time of start of cycle.

3. Operating parameters, including any of the following that apply to the treatment method being used: temperature, pressure, type of disinfectant, concentration of disinfectant, duration of treatment cycle and contact time.

4. Approximate amount of waste treated by weight, unless this information has already been recorded on an infectious waste manifest or USDOT shipping paper.

5. Generator of waste treated, if other than the owner or operator of the treatment facility, unless the waste is accompanied by an infectious waste manifest or USDOT shipping paper.

6. Results of any tests run to verify disinfection.

(d) Using manifests. Unless USDOT regulations apply, when treating infectious waste which is accompanied by an infectious waste manifest, the operator of an infectious waste treatment facility shall certify that the infectious waste has been treated according to s. NR 526.11 by doing all of the following:

1. The operator shall sign the infectious waste manifest according to s. NR 526.14 (1) (b).

2. The operator shall send a copy of the signed infectious waste manifest form along with the treated infectious waste to the solid waste disposal facility where the waste is disposed. The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment before being disposed.

3. Within 30 days of when the infectious waste was treated, the operator shall return to the generator the signed original infectious waste manifest form which certifies to the infectious waste generator that the infectious waste has been treated according to s. NR 526.11. The department may approve alternative procedures for certifying that waste has undergone infectious waste treatment.

(5) Operating requirements for licensed treatment facilities. In addition to the requirements in sub. (4), persons who operate infectious waste treatment facilities which are required to be licensed as solid waste processing facilities under sub. (1) shall meet the requirements in ss. NR 502.08 (6) to (8)502.04 and 502.05.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (1) (a), (c), (d), (2) (b), (3), (5), Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: am. (1) (c), (4) (c) 4. and 5., (d) (intro.) and 2. Register January 2006 No. 601, eff. 2-1-05.

NR 526.13 Disposal. No person may dispose of infectious waste in a solid waste disposal facility unless the infectious waste has undergone infectious waste treatment and is otherwise managed according to s. NR 526.11. Infectious waste generators shall ensure that infectious waste generated by them has undergone infectious waste treatment before disposal.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; CR 05-020: am. Register January 2006 No. 601, eff. 2-1-06.

NR 526.14 Records and infectious waste manifests.

(1)  Activities.

(a) Records. Except as provided in sub. (2), all infectious waste generators shall keep records of the amount of infectious waste sent off-site for treatment. Records shall include all the information listed under sub. (3) and retained as provided in sub. (4). Records may consist of any of the following: originals or copies of infectious waste manifests, USDOT shipping papers, invoices or records received from the infectious waste treatment facility, logs or other written documentation of the amount of infectious waste sent off-site for treatment. If USDOT shipping papers are used as records, infectious waste generators shall keep separate records of information required under sub. (3) which is not written on their USDOT shipping papers.

(b) Manifests. When USDOT regulations apply, the generator shall use a USDOT shipping paper instead of an infectious waste manifest prepared in accordance with this paragraph. Unless USDOT regulations apply or as provided in sub. (2), no person may store, transfer, transport or treat infectious waste beyond the property where the waste was generated unless the waste is accompanied by an infectious waste manifest. The infectious waste manifest may either be a Wisconsin infectious waste manifest form supplied by the department or an alternative manifest form which includes all the information required in sub. (3). After an infectious waste manifest has been initiated, all persons who store, transfer, transport or treat the waste shall sign the infectious waste manifest form, even if the infectious waste generator is exempt from manifesting under sub. (2), and shall deliver the infectious waste manifest form to the next person who handles the waste. The infectious waste transporter shall leave a copy of the manifest with the infectious waste generator at the time that the waste is removed from the generator’s facility.

Note: Wisconsin infectious waste manifest forms (DNR form 4400-176) may be obtained from the department of natural resources by writing to Wisconsin Department of Natural Resources, Bureau of Waste Management, P. O. Box 7921, Madison, Wisconsin, 53707-7921 or by calling 608-266-2111. For more information about USDOT regulations contact USDOT helpline at 1-800-467-4922.

(2) Exemptions.

(a) The following persons are exempt from all the requirements of this section:

1. Home generators of infectious waste.

2. Owners and operators of sharps collection stations.

(b) The following persons are exempt from the requirements to use infectious waste manifests under this section, but shall follow the requirement for keeping records under sub. (1) (a):

1. An infectious waste generator transporting infectious waste only on private roads on the same property where the infectious waste was generated and using vehicles owned or leased by the infectious waste generator or by one of the generators in the group.

2. An infectious waste generator transporting less than 50 pounds per calendar month of untreated infectious waste away from the property where the waste was initially generated, including items which are mixed with the infectious waste.

3. Infectious waste generators located on the same property who manage their infectious waste together and who, as a group, transport less than 50 pounds per calendar month of untreated infectious waste away from the property.

(3) Format. The infectious waste manifest form shall include all of the following information:

(a) The place of origin of the infectious waste, including the name, address, telephone number, and name of contact person and type of facility where the infectious waste was generated, including but not limited to: hospitals, clinics, nursing homes, sharps collection stations and other facilities.

(b) The route for the infectious waste, including the name, address, telephone number, license number and name of contact person for any and all persons storing, transporting or treating the infectious waste beyond the location where the infectious waste was generated.

(c) The destination for disposal of the treated infectious waste, including the name, address, telephone number, solid waste disposal facility license number and name of a contact person.

(d) The composition of the infectious waste, including the type or types of infectious waste listed in s. NR 526.05 (1).

(e) The quantity of the infectious waste, including both the number of containers and the total weight, whether known or estimated, of infectious waste including waste which is mixed with the infectious waste.

(f) The signature of an authorized representative of each facility or licensed transporter handling the waste from generation through treatment.

(4) Retention. Infectious waste manifests and records documenting the information required under sub. (3) shall be retained as follows:

(a) The infectious waste generator shall retain the copy of the infectious waste manifest received when the waste was removed from the generator’s facility and the records that certify their infectious waste was treated, as required in s. NR 526.12 (4) (d) 3. The infectious waste generator shall retain these records for at least 3 years after the waste has been treated and provide the department copies of manifests and the records documenting the information required in sub. (3) upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.

Note: Hospitals, clinics and nursing homes should keep records for at least 5 years to comply with s. NR 526.19 (9) (a) and (g).

(b) Each licensed infectious waste transporter and each owner or operator of a storage or transfer facility, combustor, incinerator or infectious waste treatment facility which handles or disinfects infectious waste shall retain a copy of each manifest, certification of infectious waste treatment according to s. NR 526.11 and records documenting the information required in sub. (3) for at least 3 years after delivering the waste to the next destination and shall provide the department copies of these documents upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.

(c) The owner or operator of a solid waste disposal facility which receives treated infectious waste shall retain a copy of the infectious waste manifest and certification of infectious waste treatment under s. NR 526.12 (4) (d) 2. for at least 3 years after disposal of the waste and shall provide the department copies of these documents upon request. If the 3-year period expires during an unresolved enforcement action, the period is automatically extended until resolution of the pending enforcement action.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am. (2) (b) 2., Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: am. (1) (a), (b) and (4) Register January 2006 No. 601, eff. 2-1-06.

NR 526.15 Infectious waste annual reports. An infectious waste generator which is either required to use manifests under s. NR 526.14 or to submit progress reports on medical waste reduction under s. NR 526.21 shall submit an annual report to the department on a form supplied by the department and the annual filing fee for the infectious waste annual report, as specified in s. NR 520.04, Table 2. An annual report form submitted by a medical facility shall be signed by the director of the facility. An annual report form submitted by other infectious waste generators shall be signed by the administrator, chief executive officer or board of directors.

(1) Groups of generators. Infectious waste generators who manifest infectious waste as a group may choose to submit a single annual report on behalf of the group and which is signed by the director of each generator in the group. Except as required under s. NR 526.21 (1), the annual report shall be submitted by March 1 for activities performed during the preceding calendar year.

(2) Generators of mass vaccination waste. This subsection applies to persons generating infectious waste during emergency mass vaccinations, including but not limited to smallpox and excluding routine vaccinations. The filing status of these generators is based on their non-mass vaccination waste, that is, the total amount of waste generated in the year minus the amount of waste generated at mass vaccination clinic or clinics. These generators are required to file an annual report only if they are required to file an annual report under this section based on their non-mass vaccination waste. Their annual report shall include the amount of the infectious waste generated at the mass vaccination clinic or clinics. Conversely, if generators of infectious waste from emergency mass vaccinations are not required to file an annual report under this section, based on their non-mass vaccination waste, they do not need to file the annual report or report the amount of their mass vaccination waste.

Note: Infectious waste annual report forms (DNR form 4400-177) may be obtained from the Department of Natural Resources, Bureau of Waste Management, 101 S. Webster Street, P.O. Box 7921, Madison, WI 52707-7921. Phone number 608-266-2111. The forms are also available on DNR’s website, http://dnr.wi.gov.

History: Cr. Register, October, 1994, No. 466, eff. 11-1-94; am., Register, June, 1996, No. 486, eff. 7-1-96; CR 05-020: r. and recr. Register January 2006 No. 601, eff. 2-1-06.

West Virginia Medical Waste Regulations

Permit Application and Approval Procedures for Non-Commercial Infectious Medical Waste Management Facilities.

4.1. This section applies only to non-commercial infectious medical waste facilities. No person may own, construct, modify or operate an infectious medical waste management facility, nor shall any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary, unless exempted by Sections 2.1., 2.2. or 4.17. of this rule.

4.2. No person shall begin physical construction of a new non-commercial infectious medical waste management facility without having received a permit.

4.3. The owner of a non-commercial infectious medical waste management facility shall be responsible for insuring that the facility has a permit.

4.4. The owner of an infectious medical waste facility shall provide public notice of intent to apply for a permit.

4.4.a. Public notice shall be given by any method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

4.5. The applicant for a permit for a non-commercial infectious medical waste facility shall maintain a public participation file. This file shall contain a summary of all comments and responses received during the pre-application public notification phase by the facility. This file shall be submitted to the Secretary by the applicant with the application.

4.6. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary and shall include the following:

4.6.a. The name, mailing address, and location of the facility, using latitude and longitude to the nearest second, for which the application is submitted;

4.6.b. The name, mailing and email addresses and telephone numbers of the owner of the facility;

4.6.c. The name, mailing and email addresses and telephone numbers of the manager of the facility, if different from the owner;

4.6.d. A copy of the proposed infectious medical waste management plan as required by Section 5 of this rule;

4.6.e. A copy of the public participation file; and

4.6.f. Information needed to demonstrate that the facility will be operated in compliance with this rule.

4.7. For new non-commercial infectious medical waste management facilities, the application shall be accompanied by a copy ofa topographic map or equivalent showing the facility and the area

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64CSR56 one thousand (1,000) feet around the facility site with the following information included:

4.7.a. The map scale and date;

4.7.b. Land uses (e.g. any established zoning for residential, commercial, agricultural, recreational, industrial or other designated uses);

4.7.c. The orientation of the map (north arrow);

4.7.d. The legalboundaries of the facility with the latitude and longitude to the nearest second for the site;

4.7.e. Access control (fences, gates); and

4.7.f. Buildings to be used for treatment, storage, and disposal operations and other structures (e.g. recreation areas, run-off control systems, access and internal roads, storm, sanitary, and process sewerage systems, loading and unloading areas, fire control facilities).

4.8. The Secretary shall not begin the evaluation of a permit before receiving a complete application, as determined by the Secretary. Within thirty (30) days of the Secretary’s receipt of a permit application, the completeness of the application shall be judged independently of the status of any other permit application or permit for the same facility or activity.

4.9. The Secretary shall not issue a permit before receiving a complete application.

4.10. The Secretary shall have the authority to request supplemental information needed to demonstrate that the facility will be operated in compliance with this rule.

4.11. When the Secretary determines an application for a new non-commercial infectious medical waste facility or a major change to an existing facility to be complete, he or she shall instruct the applicant or permittee to give public notice.

4.11.a. Public comment shall be conducted in accordance with the following guidelines:

4.11.a.1. Public notice shall be given by publishing the public notice as a Class II legal advertisement in a qualified newspaper, as defined in N Va. Code § 59-3-1, serving the county where the facility will be located. That legal advertisement shall also be placed in newspapers of adjacent counties when a proposed facility is within two (2) miles of a county line. The cost of the publication will be the responsibility of the applicant who shall send a certification of publication to the Secretary within twenty (20) days after publication; and any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

4.11.a.2. All public notices issued shall contain the following information:

4.11.a.2.A. The name and mailing and email addresses of the office processing the permit action for which notice is being given;

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64CSR56 4.11.a.2.B. The name and mailing and email addresses of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;

4.11.a.2.C. A description of the activities covered in the application, including the type of technology that will be used to treat infectious medical waste, the types, amounts, and origins ofinfectious medical waste to be handled, site improvements, and infectious medical waste handling methods;

4.11.a.2.D. The name, mailing and email addresses, and telephone numbers of a person from whom interested persons may obtain further information;

4.11.a.2.E. A general description of the location of the proposed permit area including streams;

4.11.a.2.F. A clear and accurate location map. A map of a scale and detail found in the West Virginia official state highway map is the minimum standard for acceptance. The map size shall be at a minimum two (2) inches by two (2) inches. Longitude and latitude lines and a north arrow shall be indicated on the map, and such lines will cross at or near the center of the proposed permit area; 4.11.a.2.G. A reference to the date of previous public notices relating to the permit; 4.11.a.2.H. That any interested person may submit a written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised;

4.11.a.2.1. That any interested person may submit a written request for a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and

4.11.a.2.J. That the Secretary shall conduct a public hearing within forty-five (45) days in the county where the proposed facility is to be located whenever he or she receives a request.

4.11.a.3. The availability of the application shall include, but not be limited to, copies placed at the courthouse of the county in which the facility is to be located, the city or town hall of any municipal government within two (2) miles of the proposed location of the facility, and the primary public library in the county.

4.11.a.4. Copies of the application shall be available from the Secretary.

4.11.b. If any data, information or arguments submitted during the public comment period raise substantial new questions concerning the proposed major change or new facility, the Secretary shall:

4.11.b.1. Request additional information from the applicant; and

4.11.d.1.A. Reopen or extend the public comment period for thirty (30) days to give interested persons an opportunity to comment on the information or argument submitted; or

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64CSR56 4.11.d.1.B. Require a public hearing.

4.11.c. In the event a public hearing is held:

4.11.c.1. Public notice of the hearing shall be given by the Secretary at least thirty (30) days before the hearing;

4.11.c.2. A transcript of the hearing shall be available to the public from the Secretary;

4.11.c.3. At the hearing, any person may make oral comments and submit written statements and data concerning the proposed major changes or new facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted to the Secretary no later than ten (10) days after the close of the hearing; and

4.11.c.4. The Secretary shall act on the permit application within thirty(30) days after the date for the submission of written statements to the Secretary.

4.11.d. In the event a public comment period is held, the Secretary shall act on the permit application within thirty (30) days after the close of the comment period.

4.12. Permits shall be renewed annually prior to expiration. An application for permit renewal shall be submitted thirty (30) days prior to the expiration date of the previous permit. A late fee of 25% for all expired permits listed in this rule will be applied to the permit fee schedule. Payment must be received within 15 days of the expiration date to avoid the late fee assessment.

4.13. An application for an original or renewal permit shall be accompanied bya non-refundable permit fee according to the schedule shown in Table 64-56A found at the end of this rule.

4.14. A permit shall be issued if the facility is, or in the case of a projected facility, is planned to be, in compliance with the applicable provisions of this rule and has submitted the permit fee.

4.15. The Secretary may refuse to grant or renew a permit if an applicant or permittee has attempted to obtain a permit by means of fraud, deceit or material misrepresentation or public comment reveals a situation which would endanger public health.

4.16. A permittee shall submit an application for approval of a major change in the permittee’s infectious medical waste management plan before implementing the change. Minor changes in the infectious medical waste plan maybe made without notifying the Secretary and shall be included in the next application for permit renewal. All major changes shall be approved prior to implementa- tion: Provided, That, no prior approval is necessary in the case of a hospital which may in an emergency make an immediate change in its plan necessary to protect the safety and care ofpatients, employees or the public. In such an event, the hospital shall notify the Secretary immediately followed by written notification within fifteen (15) days. An application for approval of any change in the plan which is beyond the control of the permittee shall be submitted within fifteen(15) days of its occurrence. A major change consists of any of the following:

4.16.a. Installing a new unit for the treatment of infectious medical waste or replacing

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64CSR56 existing units not including improvements, as determined by the Secretary, or repairs to existing units;

4.16.b. Changing the location of treatment; or

4.16.c. Permanently increasing the volume of infectious medical waste by at least twenty percent (20%), if the amount of the increase is fifty (50) pounds or more.

4.17. Small quantity generators who generate infectious medical waste in the provision ofhealth care services in their own office are not required to obtain a permit. Small quantity generators shall keep their infectious medical waste management plan on file and shall make a copy available to the Secretary on request.

4.18. Permits issued by the Secretary for a non-commercial infectious waste facility are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing large quantity generator that changes ownership, however, may continue to operate under the previous owner’s permit conditions until such time as the Secretary can process the new permit application required by this section, provided the new owner sends the Secretary a letter in which the new owner:

4.18.a. Advise the Secretary of any change of ownership including any management changes; and

4.18.b. Agree to be bound by the conditions and policies established in the infectious medical waste management plan for that facility by the previous owner until such time as a new management plan can be approved by the Secretary.

§64-56-5. Infectious Medical Waste Management Plan.

5.1. All infectious medical waste management facilities shall develop an infectious medical waste management plan.

5.2. The infectious medical waste management plan shall set forth policies and procedures for managing infectious medical waste which are consistent with this rule and shall include, at a minimum, the following:

5.2.a. A projection of the weight of the infectious medical waste which will be generated monthly;

5.2.b. A description of infectious and noninfectious medical waste handling, storage, separation and volume-reduction procedures;

5.2.c. The methods which will be used to treat the infectious medical waste;

5.2.d. Transportation method;

5.2.e. Manifest systems or shipping documents and labeling;

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64CSR56 5.2.f. Disposal methods consistent with Section 10.4 of this rule;

5.2.g. The name, mailing and email addresses, and telephone numbers and public service commission or other permit or license number of any infectious medical waste transporter, if applica- ble;

5.2.h. Training procedures, including an outline of training programs, and procedures for the certification of personnel involved in the treatment of infectious medical waste;

5.2.i. The name, mailing and email addresses, and telephone numbers of the person responsible for infectious medical waste management at the generator or the facility, and the name, mailing and email addresses, and telephone numbers of an alternate person to contact in the event the manager is not available;

5.2.j. Policies requiring that no infectious medical waste will be knowingly transported or knowingly received by the generator or facility without being packaged and labeled in accordance with this rule;

5.2.k. Contingency plans for effective action to minimize damage from any interruption in treatment, storage or disposal of infectious medical waste;

5.2.1. A description of the procedures used to:

5.2.1.1. Prevent hazards in loading and unloading operations;

5.2.1.2. Prevent run-off from infectious medical waste handling areas to other areas of the facility or environment;

5.2.1.3. Prevent contamination of water supplies;

5.2.1.4. Mitigate effects of equipment failure and power outages;

5.2.1.5. Prevent exposure of personnel to infectious medical waste; and

5.2.1.6. Address spill prevention and spill mitigation procedures;

5.2.1.6.a Include procedure for use of personal protective equipment(PPE); and

5.2.1.6.b. Include contents of the required spill kit, set forth in section 7 of this rule.

5.2.m. Procedures for continuity of operations during a change of ownership;

5.2.n. Any other information pertinent to the evaluation of compliance with this rule.

5.3. Infectious medical waste management facilities which are willing to accept infectious medi- cal waste generated off-site for treatment shall also include the following in their infectious medical waste management plan:

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64CSR56

5.3.a. Procedures for receiving off-site infectious medical waste which are consistent with this rule;

5.3.b. A statement as to whether the facility plans to receive from off-site more than thirty- five (35) percent by weight of the total amount of infectious medical waste at the facility;

5.3.c. A statement that the facility will not knowingly accept any infectious medical waste which is not properly packaged and labeled in accordance with Section 6 of this rule;

5.3.d. Procedures for keeping records in accordance with Section 13 of this rule;

5.3.e. Procedures for returning manifests or other shipping documents to the generator after treatment of the infectious medical waste;

5.3.f. Procedures for reporting to the Secretary as required by this rule; and

5.3.g. Procedures to be followed for closure of the facility including, but not limited to, notification of all facilities using the treatment service thirty (30) days prior to closure.

5.4.The infectious medical waste management plan shall comply with this rule.

5.5. Infectious medical waste management facilities shall operate in compliance with their infectious medical waste management plan as approved by the Secretary.

5.6. Disposal of untreated infectious medical waste in this State is prohibited.

§64-56-6. Packaging and Labeling.

6.1. General.

6.1.a. The generator of infectious medical waste shall be responsible for ensuring that the packaging and labeling ofinfectious medical waste is in compliance with this rule and any other ap- plicable state or federal laws or regulations.

6.1.b. Contractors or other agents may provide services to the generator, including packaging and labeling ofinfectious medical waste: Provided, however, that no contract or other relationship shall relieve the generator of the responsibility for packaging and labeling the infectious medical waste as required by this rule. Nothing in this section shall be construed to prevent or limit any cause of action by a generator against any other party for any reasons for which the law gives a remedy.

6.1.c. No person shall knowingly accept for transportation, storage, treatment or disposal any infectious medical waste that is not packaged and labeled in accordance with this rule. Contractors or other agents may package or repackage infectious medical waste to comply with this rule, if the packaging or repackaging is performed prior to transportation off-site or storage on-site. Proper repackaging of infectious medical waste that has spilled during transportation is required prior to further transportation.

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64CSR56

6.2. Packaging.

6.2.a. All infectious medical waste shall be packaged as required by this rule prior to storage, treatment, or transport.

6.2.b. Infectious medical waste shall be contained and sealed on-site in leak-proof plastic bags as required by 49CFR173.197. Free liquids shall be contained in break-resistant, tightly stoppered containers. Heavier materials shall be supported in double-walled comigated fiberboard boxes or equivalent rigid containers.

6.2.c. Sharps shall be collected at the point of generation in rigid, leak-proof and puncture-resistant containers clearly marked as infectious medical waste. Containers shall be compatible with selected treatment processes to preclude contact with waste materials, and sealed before handling. Sharps containers shall not be completely filled.

6.2.c.1. If the sharps are to be stored or treated off-site, the containers shall be placed inside a plastic bag as specified in Section 6.2.b of this rule. Prior to storage, the plastic bags shall be bound at the gathered open end with tape or another closing device that prevents leakage of liquids. Transporters utilizing properly constructed transport carts for large sharps containers which secure the containers are exempt from this requirement.

6.2.c.2. Sharps which are rendered noninfectious and encapsulated in a solid state on-site may be discarded as solid waste. The encapsulated container shall be labeled in accordance with Section 6.3.b of this rule.

6.2.d. Bags containing infectious medical waste at facilities where on-site treatment will occur shall be red in color except that infectious medical waste that is to be steam treated shall be contained in orange bags and marked with autoclave tape or other heat-activated ink which will indi- cate whether or not the appropriate temperature, as required by this rule, has been reached. Both red and orange bags shall be imprinted with the international biohazard symbol and the words “infectious medical waste” or “biomedical waste” or “biohazard” or “regulated medical waste”. Waste contained in red bags shall be considered infectious medical waste and managed as infectious medical waste. Waste contained in orange bags shall be managed as infectious medical waste prior to steam treatment and as solid waste after steam treatment. This waste shall not be removed from the orange bags and shall not be enclosed in bags of different colors.

6.2.e. Bags containing infectious medical waste which is to be transported off-site for treatment shall be red in color and shall be imprinted with the internationalbiohazard symbol and the words “infectious medical waste” or “biomedical waste” or “biohazard” or “regulated medical waste. Waste contained in red bags shall be considered infectious medical waste and managed as infectious medical waste. In addition to other packaging, all infectious medical waste which is to be trans- ported off-site shall also be packaged in double-wall corrugated fiberboard boxes or equivalent rigid containers. The boxes or containers shall be leak-resistant and lined with a tear-resistant leak-proof plastic bag.

6.2.f. Reusable containers shall be leak-proof and, shall have tight-fitting covers, and shall be kept clean and in good repair. Reusable containers shall be thoroughly washed and disinfected.

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64CSR56 Disposable liners, bags or other devices shall be removed and handled as infectious medical waste. Red bags may not be enclosed in bags of different colors.

6.2.g. Disinfection of the container shall be accomplished by one of the following methods:

6.2.g.1. Immersion in hot water at a temperature of at least one hundred and eighty degrees Fahrenheit(180 °F) for a minimum of thirty (30) seconds;

6.2.g.2. Exposure to a chemical sanitizer by immersion in one of the following for a minimum of thirty (30) seconds: hypochlorite solution of one hundred parts per million (100 ppm) available chlorine; iodoform solution of twenty-five parts per million (25 ppm) available iodine; or quaternary ammonium solution of two hundred parts per million (200 ppm) active agent per manufacturer’s instructions; or

6.2.g.3. Swabbing or rinsing the container with a chemical sanitizer double the strength specified in Section 6.2.g.2 of this rule or a chemical with equivalent sanitizing capabilities.

6.2.h. Employers shall direct employees packaging infectious medical waste to use personnel protection equipment and shall provide training in its use.

6.3. Labeling Requirements.

6.3.a. Infectious medical waste to be transported off-site shall be labeled prior to being stored on-site or transported off-site. The label shall be securely attached to the outer layer of packaging and shall be clearly legible. Permanent ink shall be used to complete the information on the label and, if handwritten, the label shall be at least three (3) inches by five (5) inches in size. The following information shall be included on the label:

6.3.a.1. The name, address, business telephone numbers of the generator;

6.3.a.2. The name, address, business telephone numbers of all transporters; and

6.3.a.3. The date on which the infectious medical waste was packaged.

6.3.b. Recognizable treated noninfectious medical waste shall be labeled prior to being transported off-site. Treated medical waste that will pass through a screen with a one-half inch(1/2) grid shall be considered not recognizable. The label shall meet the requirements in Section 6.3.a of this rule for infectious medical waste. The following information shall be included on the label:

6.3.b.1. The name, address and business telephone numbers of the generator;

6.3.b.2. The name, address, and business telephone numbers of the facility at which the waste was rendered noninfectious;

6.3.b.3. The weight of the treated noninfectious medical waste and the method of treatment; and

6.3.b.4. A signed and dated certification by the facility where the waste was rendered

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64CSR56 noninfectious which states: “I hereby certify under penalty of law that this waste has been rendered noninfectious in accordance with procedures required by Infectious Medical Waste Rule, 64CSR56.”

6.4. Facilities that render infectious medical waste non-infectious within their facility, may manifest the entire load of treated waste in lieu of individual bag labeling. The facility shall apply to the Secretary for a waiver with rationale supporting the request. Once approved, the changes and procedures shall be reflected in the Infectious Medical Waste Management Plan. Commercial treatment facilities are exempt from this requirement. Facilities currently in operation at the effective date of this rule that render infectious medical waste non-infectious within their facility are not required to apply for a waiver.

§64-56-7. Management of Spills of Infectious Medical Waste.

7.1. All infectious medical waste management facilities shall provide a spillkit for management of spills of infectious medical waste.

7.2. Large Quantity Generators of infectious medical waste shall keep a spill containment and cleanup kit within the vicinity of any area where infectious medical waste is managed on a bulk storage basis. The location of the kit shall provide for rapid and efficient cleanup of spills anywhere within the area.

7.2.a. The kit shall contain an amount of absorbent material sufficient to have a rated capaci- ty of one (1) gallon of liquid for every cubic foot ofinfectious medical waste that is normally man- aged in the area for which the kit is provided or of ten (10) gallons, whichever is less.

7.2.b. The kit shall contain one (1) gallon of hospital grade disinfectant ie and a sprayer capable of dispersing its charge in a mist or in a stream at a distance. The disinfectant shall be hospital-grade and effective against mycobacteria.

7.2.c. The kit shall contain enough red plastic bags to enclose one hundred and fifty percent (150%) of the maximum quantity stored. The bags shall meet the requirements in 6.2 of this rule and shall be accompanied by sealing tape or devices and labels or tags. These bags shall be large enough to enclose any box or other container normally used for infectious medical waste management by that facility.

7.2.d. The kit shall contain two (2) new sets of overalls, gloves, boots, caps, and devices to protect the eyes and respiratory tract, and tape for sealing wrists and ankles. The overalls, boots and caps shall be oversized or fitted to the infectious medical waste workers or transporters, and shall be made of materials impermeable to liquids. Boots maybe of thick rubber and gloves shall be ofheavy neoprene or equivalent material. Boots, gloves and breathing devices may be reused if disinfected between uses.

7.2.e. The kit shall contain an adequate first aid kit and an adequate amount of boundary marking tape.

7.3 Small Quantity Generators of infectious medical waste shall keep a spill containment and cleanup kit within the vicinity of any area where infectious medical waste is managed .The location of the kit shall provide for rapid and efficient cleanup of spills anywhere withln the area.

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7.3.a.The kit shall contain, at a minimum the following:

7.3.a.1. Two (2) red plastic bags that meet the requirements in 6.2 of this rule;

7.3.a.2. One (1) pair of gloves impervious to moisture;

7.3.a.3. One (1) face mask (surgical type or equivalent);

7.3.a.4. One (1) pair of goggles or equivalent eye protection;

7.3.a.5. Absorbent material capable of absorbing one-half(1/2) gallon of liquid;

7.3.a.6. Spray can of disinfectant effective against tuberculosis/mycobacterium; and

7.3.a.7. A disposable dust pan and broom for sweeping up sharps.

7.3.b. The above items shall be stored in a heavy container with a tight fitting lid, appropriately labeled, and which can be used to contain wastes generated after a clean-up.

7.4. All vehicles transporting infectious medical waste shall carry a spill containment kit in the vehicle whenever infectious medical waste is conveyed. The kit shall contain at a minimum the following:

7.4.a. An adequate amount of absorbent material;

7.4.b. One (1) gallon of hospital grade disinfectant in a sprayer capable of dispersing its charge in a mlst or in a stream at a distance. The disinfectant shall be hospital-grade and effective against mycobacteria;

7.4.c. Fifty (50) red plastic bags that meet the requirements in 6.2. of this rule. The bags shall be accompanied by seals and appropriate labels, and shall be large enough to over-pack any container normally transported in the vehicle; 7.4.d. Two (2) new sets of overalls, gloves, boots, caps, face mask, goggles or equivalent eye protection and tape for sealing wrists and ankles. The overalls, boots and caps shall be oversized or fitted to the infectious medical waste workers or transporters, and shall be made of materials im- permeable to liquids. Boots may be of thick rubber and gloves shall be of heavy neoprene or equivalent material. Boots, gloves and breathing devices maybe reused if disinfected between uses; and

7.4.e. A first aid kit, boundary marking tape and other appropriate safety equipment. 7.5. Immediately following a spill of infectious medical waste or its discovery, all individuals present shall leave the area until any aerosol settles.

7.6. The following procedures for cleaning up a spill shall be implemented:

7.6.a. Put on cleanup outfits as described in Section 7.1.4 of this rule and secure the spill

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area from entry by unauthorized persons; 64CSR56

7.6.b. Spray all broken containers of infectious medical waste with disinfectant; 7.6c. Place broken containers and spillage into red bags; 7.6.d. Disinfect and take other steps necessary to clean up the area;

7.6.e. Clean and disinfect non-disposable items and clothing;

7.6.f. Remove cleanup outfits and place disposable items in a red bag; and

7.6.g. Take prompt steps to initiate procedures for the replenishment of the containment and cleanup kit.

7.7. When a spill involves a single container of infectious medical waste with a weight of less than fifty(50) lbs. and a volume of spilled liquid of less than one(1) quart, the individual responsible for the cleanup may elect to use dress and procedures other than those required by Section 7.1.d of this rule. Any proposed alternate procedures for small quantity spills shall be specified in the in- fectious medical waste management plan and shall provide protection to the health of workers and the public equivalent to that provided by the procedures specified in Section 7.2 of this rule.

§64-56-8. Storage of Infectious Medical Waste.

8.1. This section is applicable to the storage of infectious medical waste at any time after packaging(sealing) for transport, including time spent during transportation and at all treatment and disposal sites or facilities.

8.2. Infectious medical waste other than sharps shall not be stored for more than thirty(30) days prior to transportation to an infectious medical waste management facility, even if refrigerated: Provided, that the total amount of storage time, including transportation to an infectious medical waste management facility, shall not exceed forty-five (45) days. Facilities that treat infectious medical waste on-site shall not store the infectious medical waste more than thirty (30) days.

8.3. Infectious medical waste shall be stored in a specifically designated area located at or near the treatment site, or at the pickup point if it is to be transported off-site for treatment.

8.4. The manner of storage shall maintain the integrity of the containers; prevent the leakage of waste from the container; provide protection from water, rain and wind, and maintain the waste in a non-putrescent state.

8.5. All storage areas shall be constructed of materials which are durable, easily cleanable, impermeable to liquids, and affords protection from animals and does not provide a breeding place or a food source for insects or rodents.

8.6. Carpets and floor coverings with open seams in which water maybe entrapped shall not be used in storage areas. All floor drains shall discharge directly to a sanitary sewage disposal system which is in compliance with Sewage System Rules, 64CSR9 or other containment system which

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64CSR56 prevents any spilled materials from reaching the environment.

8.7. All storage areas shall be kept clean and in good repair.

8.8. All storage areas shall have access control that limits access to those persons specifically designated to manage infectious medical waste. The areas shall be posted prominently with the international biohazard symbol and with warning signs located adjacent to the exterior of entry doors, gates or lids which indicate the use of the area for storage ofinfectious medical waste and that entry to unauthorized persons is denied.

8.9. Infectious medical waste shall not be placed in chutes at any time.

8.10. Compaction of infectious medical waste or subjecting infectious medical waste to mechanical action is prohibited unless as a part of a specific treatment process approved by the Secretary.

§64-56-9. Transportation.

9.1. This section applies to all transportation ofinfectious medical waste over roads or highways within West Virginia, regardless of point of origin or intended disposal, except as specified in Sections 9.2 and 9.3 of this rule.

9.2. A small quantity generator may transport his or her infectious medical waste to a permitted infectious medical waste management facility, or may arrange for transport by his or her employee as follows:

9.2.a. An employee who transports the infectious medical waste shall be trained in the proper handling of infectious medical waste as required by this rule; and

9.2.b. The infectious medical waste shall be delivered within forty-five (45) days of its generation, or

9.2.c. Via the U.S. postal service or other commercial delivery services, if the requirements set by that agency are met.

9.3. A generator that transfers infectious medical waste on- site shall be exempt from Sections 9.9, 9.10, 9.11 and 9.12 of this rule: Provided, that:

9.3.a. On-site transfer ofinfectious medical waste is covered in the infectious medical waste management plan; and

9.3.b. No off-site infectious medical waste is knowingly and routinely accepted for on-site transfer.

9.4. No person shall knowingly receive for transportation any infectious medical waste that is not packaged and labeled in accordance with Section 6 of this rule.

9.5. A transporter shall deliver infectious medical waste in West Virginia only to a permitted in-

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64CSR56 fectious medical waste management facility. Transporters of infectious medical waste out of state shall transport it to a facility permitted by the receiving jurisdiction.

9.6. All vehicles transporting infectious medical waste shall be prominently identified while transporting the infectious medical waste with the following, except for vehicles used as specified in Sections 9.2 and 9.3 of this rule:

9.6.a. The international biohazard symbol;

9.6.b. The words “infectious medical waste”, or “biomedical waste”, or “biohazard” or “regulated medical waste”;

9.6.c. The number of the transporter’s permit issued by the Secretary; and

9.6.d. If applicable, a placard in accordance with United States Department of Transportation requirements. Removable signs are acceptable.

9.7. Vehicles that transport infectious medical waste:

9.7.a. Shall include a cargo-carrying portion that shall be closed and secured except when loading or unloading infectious medical waste to prevent unauthorized access and exposure to wind and precipitation;

9.7.b. Shall be designed and constructed so as to minimize any spillage;

9.7.c. Shall be cleaned and disinfected following leakage or spills as provided in Section 6.2.g.3 of this rule;

9.7.d. Shall be cleaned and disinfected prior to using the conveyance for any other purpose as provided in Section 6.2.g.3 of this rule; and

9.7.e. Shall not be used to transport food, foodstuffs, food additives, food containers or any substances to be ingested by people or animals or applied to food or feed simultaneously with the transport of infectious medical waste.

9.7.f. Separate, removable cargo-carrying containers are acceptable and if used, Sections 9.7.a through 9.7.e of this rule shall apply to the containers in lieu of the entire vehicle.

9.8. All vehicles transporting infectious medical waste shall carry a spill containment and cleanup kit as required by Section 7 of this rule in the vehicle whenever infectious medical waste is conveyed. Spills ofinfectious medical waste during transportation shall be managed as required by Sections 7.5 and 7.6 of this rule. Any spill of fifty (50) pounds or more shall be reported as soon as possible to the employer and the Secretary. Direct physical contact of the transport vehicle or equip- ment with infectious medical waste shall be considered and managed as a spill.

9.9. No person shall transport infectious medical waste in West Virginia for another who does not possess a permit issued by the Secretary, and, if applicable, valid authority issued by the public service commission. Permits issued by the Secretary shall not be transferable or assignable and shall

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64CSR56 automatically become invalid upon a change of ownership or upon suspension or revocation.

9.10. An application for a permit to transport infectious medical waste shall be made in writing to the Secretary on a form prescribed by the Secretary. The application form shall be signed by the applicant or his or her authorized representative. The application shall contain at a minimum the following:

9.10.a. The applicant’s name;

9.10.b. The business and email addresses and telephone numbers of the applicant, including both headquarters and local office;

9.10.c. The number of vehicles being permitted to transport infectious medical waste within West Virginia;

9.10.d A description of the vehicles being permitted;

9.10.e. The name of any person or firm other than reported in Section 9.10. of this rule that is associated with the applicant or any other name under which that person or firm does business;

9.10.f. The name of any other person or firm using any of the same vehicles and operators;

9.10.g. The name and telephone numbers of a person who maybe contacted in the event of an accident or spill;

9.10.h. Verification that the applicant has established a program of and is providing training for employees involved in the transportation ofinfectious medical waste as required by this rule; and

9.10.i. Designation of the treatment facilities to be used.

9.11. The application shall be accompanied by a fee per transport vehicle according to the fee schedule shown in Table 64-56A found at the end of this rule. An application for renewal shall be submitted with the fee thirty (30) days prior to the expiration date of an existing permit.

9.12. Once the application has been approved by the Secretary, and upon verification that the applicant has been duly authorized by the public service commission, if applicable, a permit for the number of vehicles on the application shall be issued to the applicant. All transport vehicles shall display the decal provided by the public service commission as required by the commission. The original permit issued by the Secretary shall be kept in the transport vehicle at all times.

9.13. Permits for transport vehicles issued after the effective date of this rule will expire at midnight on the 31ˢᵗ day of December following the date of issuance.

9.14. Upon request, the transporter shall provide the Secretary with information needed for the investigation of the handling of particular infectious medical waste including, but not limited to, the names, addresses and telephone numbers of transporters from or to whom the transporter has received or transferred infectious medical waste and infectious medical waste management facilities and generators with which the transporter has a contract or agreement for services.

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64CSR56

9.15. All infectious medical waste transport vehicles shall be subject to inspection by the Secretary without prior notice to evaluate compliance with this rule.

§64-56-10. Methods of Treatment.

10.1. General.

10.1.a. All infectious medical waste shall be treated by one of the following methods:

10.1.a.1. Incineration as described in Section 10.2 of this rule;

10.1.a.2. Steam treatment as described in Section 10.3 of this rule;

10.1.a.3. Discharge to a sanitary sewer as described in Section 10.4 of this rule; or

10.1.a.4. Any other alternative method approved in writing and permitted by the Secretary according to the provisions of Section 10.5 of this rule.

10.1.b. The residue or ash remaining after the treatment of infectious medical waste in accordance with this rule becomes noninfectious medical waste and maybe disposed of in the same manner as ash from solid waste incineration and as provided in subdivision 10.2.e. of this rule.

10.2. Incineration.

10.2.a. All owners and operators of infectious medical waste incinerators are required to comply with applicable State laws and with rules of the West Virginia Department of Environmental Protection’s Division of Air Quality.

10.2.b. Whenever infectious medical waste is introduced into an incinerator, all the waste shall be subjected to a burn temperature of not less than one thousand four hundred degrees Fahrenheit (1400 °F) for a period not less than one (1) hour. Gases generated by the combustion shall be subjected to a temperature of not less than one thousand eight hundred degrees Fahrenheit (1800 °F) for a period of one (1) second or more.

10.2.c. An incinerator used for treatment ofinfectious medical waste shall have interlocks or other process control devices to prevent feeding of the incinerator until the conditions specified in Section 10.2.b of this rule can be achieved. In the event low temperatures occur, facilities shall have automatic auxiliary burners which are capable, excluding the heat content of the waste, of independently maintaining the secondary chamber temperature at the minimum of one thousand eight hundred degrees Fahrenheit (1800 °F).

10.2.d. There shall be continuous monitoring and recording of primary and secondary chamber temperatures. Monitoring data shall be maintained for a period of three (3) years.

10.2.e. All combustible waste shall be converted by the incineration process into ash that is not recognizably in its pre-incineration form. Incinerator ash shall be tested at least quarterly, using a commingled random sample, for total organic carbon content, and annually for lead, mercury,

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64CSR56 cadmium, and other heavy metals. A maximum of five percent (5%) fixed carbon shall be permitted (minimum ninety-five percent (95%) burnout).

10.2.f. All individuals who operate infectious medical waste incinerators shall be registered with the Secretary. The Secretary shall issue a registration number to individuals who complete a course of study approved by the Secretary; obtain a passing score on a written examination; and pay the fee shown in Table 64-56A found at the end of this rule.

10.3. Steam Treatment.

10.3.a. A steam treatment process for infectious medical waste shall at all times maintain:

10.3.a.1. A temperature of not less than two hundred and fifty degrees Fahrenheit (250 °F) for ninety (90) minutes at fifteen (15) pounds per square inch of gauge pressure; or

10.3.a.2. A temperature of two hundred and seventy-two degrees Fahrenheit(272 °F) for forty-five (45) minutes at twenty-seven (27) pounds per square inch; or

10.3.a.3. A temperature of two hundred and fifty degrees Fahrenheit(250 °F) for twenty- eight (28) minutes at eighty (80) pounds per square inch; or

10.3.a.4. A temperature of two hundred and seventy degrees Fahrenheit (270 °F) for sixteen (16) minutes at eighty (80) pounds per square inch; or

10.3.a.5. A temperature of two hundred and seventy degrees Fahrenheit (270 °F) for thirty (30) minutes at thirty-two (32) pounds per square inch; or

10.3.a.6. Other combinations of operational temperatures, pressure and time approved by the Secretary. Other combinations may be approved if the installed equipment has been proved to achieve a reliable kill of all infectious microorganisms in infectious medical waste at design capacity. Complete and thorough testing of such other combinations of temperature and pressure shall be fully documented, including tests of the capacity to kill Bacillus stearothermophilus. Longer steam treatment times are required when a load contains a large quantity of liquid.

10.3.b. Each package ofinfectious medical waste to be treated on-site with steam shall have a tape attached that will indicate if the steam treatment temperature has been reached. The infectious medical waste shall not be considered satisfactorily treated if the indicator does not indicate that the treatment temperature was reached during the process. Each package shall also be labeled according to the requirements of Section 6.3.b or comply with Section 6.4 of this rule after treatment if recognizable.

10.3.c. Steam treatment units shall be evaluated under full loading for effectiveness with spores of Bacillus stearothermophilus no less than once per every forty (40) hours of operation.

10.3.d. A log shall be kept at each steam treatment unit that is complete for the preceding three (3) year period. The log shall record:

10.3.d.1. The date, time and operator of each usage;

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64CSR56

10.3.d.2. The type and approximate amount of waste treated;

 only); 10.3.d.3. The post-treatment reading of the temperature sensitive tape (on-sitetreatment

10.3.d.4. The dates and results of calibration; and

10.3.d.5. The results of the testing required by Section 10.3.c of this rule.

10.3.e. Where multiple steam treatment units are used, a working log can be maintained at each unit and such logs periodically consolidated at a central location. The consolidated logs shall be retained for three (3) years and be available for review.

10.4. Sanitary Sewer.

Liquid infectious medical waste maybe discharged to a sanitary sewer through a drainage fixture of a size and type adequate to discharge the waste in a sanitary manner to a sewer system approved by the Secretary according to Sewage System Rules, 64CSR9. The use of a grinder to reduce infectious solid matter to a size or consistency which can be discharged to a sewer is prohibited.

10.5. Alternative Methods.

10.5.a. The Secretary may approve an alternative method of treatment not described in this rule if the Secretary determines that the proposed process will render infectious medical waste noninfectious and will provide protection to the health and safety of the public and workers at least the equivalent to the methods found at Sections 10.2, 10.3 or 10.4 of this rule.

10.5.b. The Secretary may issue provisional approval to any alternate method until an appropriate trial period can validate performance. Alternate methods employing disinfection must have the disinfectant registered for that purpose in accordance with the federal Insecticide, Fungicide, and Rodenticide Act as amended. If the process fails to provide adequate treatment when operated according to manufacturer’s instructions, the provisional approval shall be revoked.

10.5.c. In addition to complying with other sections of this rule, an application for approval of an alternate method shall include:

10.5.c.1. A listing of the classes and amounts of infectious medical waste the method could be employed to treat;

10.5.c.2. A copy of the detailed plans for the device used in the method;

10.5.c.3. A written summary of the proper operation of the method and device;

10.5.c.4. A copy of the operation and maintenance manual for the process or device;

10.5.c.5. Copies of approval and denial letters from other states where the process has been evaluated; and

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64CSR56

10.5.c.6. A copy of an evaluation report provided bya testing laboratory independent of the applicant using a testing protocol approved by the Secretary confirming the efficacy of the treatment process and that the process does not produce a hazardous waste, discharge or air emission.

10.5.d. To evaluate alternative treatment technologies, the Secretary shall use the procedures outlined in the following referenced manual that is incorporated in this rule: State and Territorial Association on Alternate Treatment Technologies, Technical Assistance Manual: State Regulatory Oversight of Medical Waste Treatment Technologies.

10.5.e. A non-refundable alternative technology evaluation fee shall be submitted with the application in accordance with Table 64-56A at the end of this rule.

§64-56-11. Commercial Infectious Medical Waste Management Facilities.

11.1. This section of this rule applies only to commercial infectious medical waste management facilities.

11.2. A commercial infectious medical waste management facility may not utilize incineration technology in any form, including the manufacture or burning of refuse-derived fuel in any form.

11.3. A commercial infectious medical waste management facility shall have effective controls for the management of infectious medical waste to ensure the protection of public health, safety, welfare and the environment.

11.4. The Secretary shall conduct an investigation of the infectious medical waste stream in the region affected by the proposed facility and determine that programs have been established to minimize and reduce the infectious medical waste stream the facility will serve prior to issuing a permit. The Secretary may issue a permit only if he or she makes a specific finding that as to the medical waste stream the proposed facility will be consistent with the legislative findings and purpose stated in N Va. Code § 20-5J-2.

11.5. No person may establish, construct, operate, maintain, or allow the use of property for a commercial infectious medical waste management facility within:

11.5.a. The one-hundred (100) year flood plain;

11.5.b. Five hundred (500) feet of a dwelling, measured from the edge of the boundary of the facility, unless written permission is received from the owner of the dwelling;

11.5.c. An area where the Secretary has determined, after consultation with relevant state and federal agencies, that the facility will be in violation of applicable state or federal laws or regulations concerning:

11.5.c.1. Wetlands;

11.5.c.2. Any endangered or threatened species of animal or plant;

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11.5.c.3. Surface water; 64CSR56

11.5.c.4. Groundwater quality; or

11.5.c.5. The emission of any air contaminant.

11.6. A proposed infectious medical waste management facility shall provide evidence of financial capability suitable to the scope of the facility to the Secretary.

11.6.a. Prior to the issuance of a permit to operate a commercial infectious medical waste treatment facility, the intended operator shall obtain a performance bond payable to the Secretary in an amount established by the Secretary equal to the projected cost of operating the facility for sixty (60) days at full capacity.

11.6.a.1. The performance bond shall be paid to the Secretary upon:

11.6.a.1.a. Closure of the facllity, including voluntary closure and closure as a result of permit revocation or suspension, unless thirty (30) days before closure the operator has notified the Secretary of closure and before closure has provided the Secretary with certified mail receipts of its mailing of notices of closure to all its customers thirty(30) days before closure: Provided, That a performance bond payment made under this subparagraph shall be returned by the Secretary upon verification that the operator provided the notices as required; or

11.6.a.1.b. Improper closure of the facility requiring corrective expenditures by the Secretary.

11.6.a.2. A bond payment may be used by the Secretary to correct an improper closure and to continue operation of a facility until its customers can be properly notified of the pending closure.

11.7. No person may own, construct, modify or operate a commercial infectious medical waste facility, nor may any person store, transport, treat or dispose of any infectious medical waste without first obtaining a permit from the Secretary.

11.8. The owner of an infectious medical waste facility is responsible for insuring that the facility has a permit.

11.9. Pre-siting Notices.

11.9.a. In order to obtain approval to locate a commercial infectious medical waste facility, an applicant shall, in accordance with N Va. Code § 20-5K-3, Procedure for Public Participation, file a pre-siting notice with the Secretary, the department of environmental protection and the county commission or commissions and the local solid waste authority or authorities of the county or counties in which the facility is to be located. Such notice shall be available for public review, and shall include:

11.9.a.1. A description of the location at which the proposed facility may be sited;

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64CSR56 11.9.a.2. Information concerning the anticipated size of the proposed facility;

11.9.a.3. An estimate of the volume, type, and origin of the infectious medical waste to be handled at the proposed facility;

11.9.a.4. A United States Geological Survey (USGS) topographic map showing the location and anticipated boundaries of each site being considered for the proposed facility;

11.9.a.5. A description of the technology that is to be used in the treatment ofinfectious medical waste;

11.9.a.6. The name, address, telephone numbers and e-mail-address of the owner or applicant of the proposed facility;

11.9.a.7. The name, address, telephone numbers and e-mail address of the operator of the proposed facility, if different from the owner or applicant; and

11.9.a.8. Other information that the Secretary may require.

11.10. Permit Application Requirements. An application for a permit shall be submitted to the Secretary on forms prescribed by the Secretary, and unless otherwise specified in this rule, shall include the following:

11.10.a. The name, mailing address, and location of the facility for which the application is submitted;

11.10.b. The name, address, telephone number and e-mail address of the owner of the facility, and if the owner is an individual or a partnership;

11.10.c. The name, address, telephone number and e-mail address of the manager of the facility, if different from the owner; and if the manager is an individual or partnership different from the owner;

11.10.d. A proposed infectious medical waste management plan as required by Section 5 of this rule. The infectious medical waste management plan shall be incorporated into the permit as part of the permit conditions;

11.10.e. A description of the legal documents upon which the applicant bases his or her legal right to enter and conduct operations on the facility permit area and whether that right is the subject of pending court litigation;

11.10.f. All application documents related to engineering and design plans and specifications as compiled, signed, and sealed by a professional engineer who is registered to practice in West Virginia;

11.10.g. Appropriate legible exhibits, including maps, figures, photographs, and tables, of appropriate scale to show all required details necessary to clarify information or conclusions;

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64CSR56 11.10.h. Documentation of arrangements for permitted facilities to receive all treated waste and wastewater;

11.10.i. A treatment technology plan in accordance with the provisions of Section 10.3 through 10.5 of this rule;

11.10.j. Financial assurance in the form ofa collateral bond, an escrow account or a letter of credit equal to the proposed cost of the project;

11.10.k. A proposed design and a general discussion of the proposed operating procedures;

11.10.1. A notarized signature of the owner or principal officer verifying that the information contained in the application is true and correct to the best of that individual’s knowledge and belief;

11.10.m. A review of land use zoning in the area with particular attention given to areas where zoning variances will be required, where agricultural impact statements may be required, or where flood plain, river corridors, or wetlands are designated;

11.10.n. A description of the present land use within two (2) miles of the permit area. The description shall include, but not be limited to:

11.10.n.1. Impacts upon transportation facilities;

11.10.n.2. Impacts upon public and private water supplies;

11.10.n.3. Impact upon land use patterns;

11.10.n.4. Impacts upon agricultural, commercial and residential real estate values;

11.10.n.5. Impacts upon wildlife;

11.10.n.6. Impacts upon endangered or threatened species of animals or plants;

11.10.n.7. Impacts upon aesthetics;

11.10.n.8. Impacts upon socioeconomic conditions;

11.10.n.9. Impacts to water resources;

11.10.n.10. Impacts on sewage collection and treatment systems; 11.10.n.11. Impacts on local emergency response crews and firefighters; 11.10.n.12. Impacts upon known recreational, historical, archaeological, or environmentally unique areas; and

11.10.n.13. Other impacts as determined by the Secretary;

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64CSR56 11.10.o. A large-scale map with a minimum scale of one (1) inch equal to two hundred (200) feet and a maximum contour interval often (10) feet, or a 7.5 minute topographic map, showing the location of all of the following that occur either within the site boundaries or within two thousand five hundred (2,500) feet of the site:

11.10.o.1. Water supply wells;

11.10. .2. Springs;

11.10.o.3. Wetlands (e.g., swamps, bogs, marshes);

11.10.o.4. Streams and drainages;

11.10.o.5. Public water supplies;

11.10.o.6. Other bodies of water;

11.10.o.7. Underground or surface mines;

11.10.o.8. Water quality monitoring points;

11.10.o.9. Occupied dwellings; 11.10.o.10. Roads; 11.10.o.11. Public buildings; 11.10.o.12. Sinkholes; 11.10.o.13. Property boundaries, including site property; 11.10.o.14. Current owners of record both surface and subsurface; 11.10.o.15. Easements or rights-of-way; and 11.10.o.16. One hundred (100) year flood plain boundary;

11.10.p. A description of present and proposed transportation routes and access roads, including any weight restrictions;

11.10.q. A description of buildings, treatment units, roads, and other structures to be constructed in conjunction with the facility, including the size of the construction and the number of miles of road to be constructed;

11.10.r. A description of emissions and discharges, such as dust, odors, gases, leachate, surface water runoff and collected groundwater associated with facility preparation, construction, operation and during and after closure of the facility;

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64CSR56 11.10.s. A copy of any building permits required; and

11.10.t. A non-refundable application fee according to the schedule shown in Table 64-56A at the end of this rule.

11.11. Modifications.

11.11.a. When a permit is modified, only the conditions subject to modification are reopened. All other conditions of the permit remain in effect for the duration of the permit.

11.11.b. The Secretary may require additional information and, in the case of a major modification, may require submission of a new permit application.

11.11.c. Minor Modifications.

11.11.c.1. Modifications, except for major modifications as listed in this section, in the infectious medical waste plan maybe made without notifying the Secretary and shall be included in the next application for permit renewal.

11.11.c.2. Permits may be modified by the Secretary at any time except for major modifications as listed in this section. Minor modifications do not require the completion of the public notice procedures.

11.11.d. Major Modifications.

A permittee shall submit an application for approval of a major modification before implementing the change. All major modifications shall be approved prior to implementation and require the opportunity for a public hearing as required by this rule unless an emergency is declared by the Secretary. For the purpose of this section a major modification means:

11.11.d.1. The capacity of the commercial infectious medical waste facility will be increased over the permitted capacity by more than ten percent (10%);

11.11.d.2. The performance or operation of the surface water control system will be significantly affected;

11.11.d.3. A decrease in the quality or quantity of data from any environmental monitoring system will occur;

11.11.d.4. The amount or type of financial assurance will change;

11.11.d.5. The facility boundary will be significantly changed;

11.11.d.6. Authorization is being sought to construct an additional structure used to increase the capacity of the facility;

11.11.d.7. Different permitted facilities are being considered to receive treated waste or wastewater;

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64CSR56

11.11.d.8. Installing a new unit for the treatment ofinfectious medical waste or replacing existing treatment units not to include repair or improvements to existing units;

11.11.d.9. Changing the location of treatment;

11.11.d.10. Any other action that the Secretary determines may present substantial endangerment to public health, safety or the environment; or

11.11.d.11. Other similar modifications as determined by the Secretary.

11.11.e. Major modifications to an initial application for a new commercial infectious medical waste facility require the applicant to undergo a new pre-siting process as described in Sections 11.9. through 11.12 of this rule.

11.11.f. Permit renewals that contain major modifications shall be treated as major modifications.

11.12. Permit Suspension or Revocation.

11.12.a. Suspension. A commercial infectious medical waste facility permit may be suspended by order of the Secretary for any of the following reasons:

11.12.a.1. Violation of or failure to adhere to, N Va. Code § 20-5J-1 et seq., this rule, the terms and conditions of the permit, or any order of the Secretary issued thereunder;

11.12.a.2. Interference with a representative of the Secretary in the performance ofhis or her duties; or

11.12.a.3. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee’s misrepresentation of any significant fact at any time.

11.12.b. Revocation. A commercial infectious medical waste facility permit may be revoked by order of the Secretary for any of the following reasons:

11.12.b.1. An attempt by an applicant or permittee to obtain or renew a permit by means of fraud, deceit or material misrepresentation;

11.12.b.2. Any deficiency at the facility constituting an imminent pollution, health, or safety hazard;

11.12.b.3. Persistent violation ofF Un. Code § 20-5J-1 et seq., this rule, permit terms and conditions, or orders issued by the Secretary under that Code Article or this rule;

11.12.b.4. Discovery of failure in the application, or during the permit issuance process, to fully disclose all significant facts or the permittee’s misrepresentation of any significant fact at any time;

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64CSR56

11.12.b.5. Failure to maintain proper bonding; if for any reason a permittee fails to maintain proper bonding, the Secretary shall issue a cease and desist order and revoke the permit and the permittee shall become fully liable for the amount of the bond; or

11.12.b.6. Any cause which would require disqualification pursuant to this rule from receiving a permit upon original application.

11.12.c. Effect of Permit Suspension or Revocation.

11.12.c.1. Suspension. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of suspension. Activities at the facility may recommence only after expiration of the order of suspension or upon revocation of that order by the issuing authority.

11.12.c.2. Revocation. All infectious medical waste processing, treatment, storing or transfer activities and the receipt of any infectious medical waste at the facility shall cease immediately upon receipt of an order of revocation. The facility owner shall submit either an application for a permit to close the facility or an application for a new commercial infectious medical waste facility permit within the time specified in the order of revocation.

11.12.c.3. Environmental Monitoring and Control. Environmental monitoring and control activities specified in an order of suspension or revocation shall continue at the commercial infectious medical waste facility for the duration of such order or until the authority that issued that order approves the cessation of such activities.

11.13. Transfer of Facility.

Permits issued by the Secretary are not transferable or assignable and shall automatically become invalid upon a change of ownership or upon suspension or revocation. An existing commercial facility that changes ownership may, however, continue to operate under the previous owners permit conditions until such time as the Secretary can process the new permit application required by this section, provided the new owner sends the Secretary a letter in which the new owner:

11.13.a. Advises the Secretary of such change of ownership including any management changes; and

11.13.b. Agrees to be bound by the conditions and policies established in the infectious medical waste management plan for that facility by the previous owner until such time as a new management plan can be approved by the Secretary.

11.14. Application Review. Within thirty(30) days ofreceipt of a permit application, compliance schedule, closure plan, or major modification application, the Secretary shall determine whether such application, schedule, or plan is complete and shall notify the applicant ofhis or her determination in writing. If the Secretary determines that such application, schedule, plan or modification is not complete, the notification shall advise the applicant of the deficiencies that require remedy.

11.14.a. The Secretary may not begin the evaluation of a permit before receiving a complete

31

64CSR56 application, including any supplemental information requested.

11.14.b. The Secretary may not issue a permit before receiving a complete application.

11.14.c. The Secretary shall request formal comments from the county commission of the county in which the facility is proposed to be located and from any municipal government within two (2) miles of the proposed location, with any negative response to such application from any commission or municipal government to be considered by the Secretary and specific findings made as to the concerns raised by such responses.

11.15. Public Participation.

11.15.a. When the Secretary determines an application for a new facility to be complete, he or she shall conduct a public hearing in the county where the proposed facility is to be located.

11.15.b. When the Secretary determines an application for a major modification to be complete, he or she shall instruct the applicant or permittee to give public notice. The Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.

11.15.c. Public hearings shall be conducted in accordance with the following guidelines:

11.15.c.1. Public notice of a public hearing shall be given at least thirty(30) days before the hearing. Public comment will be accepted during those thirty (30) days.

11.15.c.2. Public notice shall be given by the applicant publishing the public notice as a Class II legal advertisement in a qualified newspaper, as defined in N Va. Code § 59-3-1, serving the county where the facility will be located. The Secretary shall also require that legal advertisement be placed in newspapers of adjacent counties when a proposed facility is within two (2) miles of a county line. The cost of the publication will be the responsibility of the applicant who shall send a certification of publication to the Secretary within twenty(20) days after publication; and any other method reasonably calculated to give actual notice of the action in question to the persons potentially affected by it, including press releases or any other forum or medium to elicit public participation.

11.15.d. All public notices issued shall contain the following information:

11.15.d.1. The name and address of the office processing the permit action for which notice is being given;

11.15.d.2. The name, address and email address of the permittee or permit applicant, and if different, of the facility or activity regulated by the permit;

11.15.d.3. A description of the activities covered in the application, including the type of commercial infectious medical waste facility, the types, amounts, and origins ofinfectious medical wastes to be handled, site improvements, and infectious medical waste handling methods;

11.15.d.4. The name, address, telephone numbers and email address of a person from whom interested persons may obtain further information, including copies of the application;

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11.15.d.5. A brief description of the comment procedures and the date, time and place of the hearing, and other procedures by which the public may participate in the final permit decision;

11.15.d.6. A general description of the location of proposed permit area including streams;

11.15.d.7. A clear and accurate location map. A map of a scale and detail found in the West Virginia official state highway map is the minimum standard for acceptance. The map size shall be at a minimum two (2) inches by two (2) inches. Longitude and latitude lines and a north arrow shall be indicated on the map, and such lines will cross at or near the center of the proposed permit area;

11.15.d.8. A reference to the date of previous public notices relating to the permit;

11.15.d.9. For major modifications, the public notice shall state:

11.15.d.9.A. That any interested person may submit written comment on the application, and that such comments shall include a concise statement of the nature of the issues raised; 11.15.d.9.B. That any interested person may request a public hearing, and that such request shall include a concise statement of the nature of the issues raised; and

11.15.d.9.C. That the Secretary shall conduct a public hearing in the county where the proposed facility is to be located whenever he or she receives a request.

11.15.e. The availability of the application shall include, but not be limited to, copies placed at the courthouse of the county in which the facility is to be located, the city or town hall of any municipal government within two (2) miles of the proposed location of the facility and all public libraries in the county;

11.15.f. Copies of the application shall be available from the Secretary.

11.15.g. An official transcript of the hearing shall be available to the public from the Secretary.

11.15.h. Any person may submit oral or written statements and data concerning the proposed facility. Reasonable limits may be set on the time allowed for oral statements, and the written statements shall be submitted no later than ten (10) days after the close of public hearings.

11.15.i. If any data, information or arguments submitted during the public comment period raise substantial new questions concerning the proposed facility, the Secretary shall:

11.15.j.1. Reopen or extend the public comment period to give interested persons an opportunity to comment on the information or argument submitted; or

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64CSR56 11.15.j.2. Require an additional public hearing.

11.15.k. The applicant for a permit for a commercial infectious medical waste management facility shall maintain a public participation file. This file shall contain all the written comments received during the public comment period, copies of minutes of all meetings held by the applicant and a copy of the applicants written response to all written comment letters received during the written response period. This file shall be submitted to the Secretarybythe applicant at the end ofthe comment period.

11.15.1. Based on comments received at the public hearing or upon written recommendations received, the Secretary may within thirty (30) days after the close of the public comment period, require the person who submitted the application to furnish additional information regarding.the impact the siting of the proposed facility may have upon wetlands, endangered or threatened species of plants and animals, surface waters, underground waters, air quality, and other matters as determined by the comments received.

11.16. Permit Decision and Effective Date of Permit.

11.16.a. Within thirty(30) days of the close of the public comment period on an application for a new facility, or major modification of an existing permit, the Secretary shall respond in writing to the comments received.

11.16.b. After comments have been responded to, the Secretary shall issue a final permit decision. The Secretary shall provide written notification ofhis or her decision to the applicant and to each person who has submitted written comments or requested notice of the final permit decision. For the purposes of this section, a “final permit decision” means the final decision of the Secretary to grant, deny, revoke and reissue, or terminate a permit.

11.16.c. In the case of an application for a new facility, the Secretary shall grant or deny the application as filed and as made available to the public pursuant to the provisions ofthis section. The Secretary shall provide the reasons therefor in his or her written notification to the applicant. This notification shall also include reference to the procedures for appealing the final permit decision.

11.16.d. The Secretary may refuse to grant a permit for any of the following reasons:

11.16.d.1. If an applicant or permittee has attempted to obtain or renew a permit by means of fraud, deceit or material misrepresentation;

11.16.d.2. Discovery of failure in the application or during the permit issuance process to fully disclose all significant facts or the permittee’s misrepresentation of any significant fact at any time; or

11.16.d.3. The Secretary determines, based on comments and recommendations received, that the facility is incompatible with existing or proposed land use patterns, including, but not limited to: transportation facilities; public water supplies; water resources; agricultural, commercial and residential real estate values; aesthetics; socioeconomic conditions generally; or if it endangers public health, safety or well-being.

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64CSR56 11.16.e. A final permit decision shall become effective not less than thirty(30) days after the date of notice ofthe decision, unless an earlier date is requested by the applicant and agreed upon by the Secretary.

11.17. A retailer of sharps to be used by individuals in their own medical treatment may establish a small commercial infectious medical waste management facility to be used solely for the treatment of sharps sold by and returned to the retailer for treatment. Such small commercial infectious medical waste management facility shall apply for and obtain a permit according to the provisions of Section 4 of this rule. In addition to the requirements of Section 4, the application shall include a letter describing the location and estimated volume of sharps to be treated and a certified letter from an approved solid waste disposal facilityagreeing to accept the treated waste. Such small commercial infectious medical waste management facility shall comply with Sections 6 and 10 ofthis rule, and maybe exempted by the Secretary from the requirements of Sections 11.9 through 11.17 ofthis rule.

§64-56-12. Requirements Related to Manifests or Shipping Documents.

12.1. Except as specified in Section 12.10.ofthis rule, the generator ofinfectious medical waste that is to be transported off-site for storage or treatment shall initiate a multi-part manifest or shipping document which is available from or approved by the Secretary.

12.1.a. If a multi-part written manifest or shipping document is utilized, copy three (3) shall be retained by the generator after acceptance by the transporter. Copy two (2) shall be retained by the transporter after acceptance by the treatment facility. Copy one (1) shall be retained by the treatment facility. The treatment facility shall forward the original to the generator as required by Section 12.8 of this rule.

12.1.b. If an electronic manifest or shipping document is utilized, the transporter shall provide the generator with a printed service receipt acknowledging that the transporter has accepted the waste from the generator and the date of acceptance. The transporter shall retain an identical printed service receipt throughout transport. Within fifty (50) days after the date the medical waste was accepted by the transporter, an electronic service receipt shall be made available to the generator. If the generator does not obtain access to an electronic service receipt within fifty (50) days after the date the medical waste was accepted by the transporter, the generator shall report this fact to the Secretary.

12.2. If the generator does not receive the completed manifest or shipping document from the treatment facility within fifty (50) days after the date the medical waste was accepted by the transporter, the generator shall report this fact to the Secretary.

12.3. A transporter who commingles loads shall initiate a new manifest or shipping document.

12.4. A transporter shall not accept infectious medical waste from a generator unless the waste is accompanied by a manifest or shipping document with the generator portion signed by the generator.

12.5. A transporter shall in the presence ofthe generator or, in the event of multiple transporters, in the presence ofthe previous transporter, sign the transporter portion of the manifest or shipping document and provide the generator or previous transporter with a signed copy of the manifest or shipping document.

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64CSR56

12.6. An infectious medical waste management facility shall not accept more than fifty (50) pounds ofinfectious medical waste from a generator per month or any quantity ofinfectious medical waste from a transporter unless it is accompanied by a properly completed manifest or shipping document.

12.7. If a multi-part written manifest or shipping document is utilized, an infectious medical waste management facility shall, in the presence of the generator or transporter, complete the appropriate transport or storage, treatment or disposal facility portion of the manifest or shipping document, including a handwritten acceptance signature and date of acceptance, and immediately give a signed copy to the generator or transporter, with any discrepancies in information noted on the manifest or shipping document copy.

12.8. If a multi-part written manifest or shipping document is utilized, the infectious medical waste treatment facility shall record on the manifest or shipping document the date on which the shipment was received and accepted by the facility.

12.9. The infectious medical waste treatment facility shall keep one (1) copy of the completed manifest or shipping document as part of the facility operating record and, if a multi-part written manifest or shipping document is utilized, shall forward the original to the generator within seven(7) days after treatment.

12.10. Small quantity generators who elect to transport their own infectious medical waste are not required to use a manifest or shipping document, but shall meet the requirements in section 12.11 of this rule.

12.11. In instances when an infectious medical waste management facility accepts less than fifty (50) pounds ofinfectious medical waste from a small quantity generator, the facility shall maintain a log of such receipts which includes, at a minimum, the following:

12.11.a. The name and address of the generator;

12.11.b. The weight of the waste received;

12.11.c. The date of receipt of the waste; and

12.11.d. The signature of the person receiving the waste.

12.12. Manifests or shipping documents and logs shall be retained by all parties for a period of not less than three (3) years. The period of retention of records is extended automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary. These records shall be available for inspection by the Secretary upon request.

12.13. Nothing in this rule shall prevent any hospital or other facility which receives infectious medical waste from any small quantity generator, including any ambulance company, from requiring a completed manifest or shipping document as more fully described in Sections 12.1 through 12.6 of this rule.

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64CSR56 §64-56-13. Record Keeping and Reporting.

13.1. All pertinent records required by this rule shall be retained for a period of not less than three (3) years.

13.2. The period of retention established in Section 13.1 ofthis rule shall extend automatically during the course of any unresolved enforcement action regarding the regulated activity or as requested by the Secretary.

13.3. All records shall be made available for inspection and or duplication by the Secretary or his or her duly authorized representative upon request.

13.4. All generators, except small quantity generators and those listed in Section 2 ofthis rule, commercial storage and transfer facilities and treatment facilities shall submit a report annually covering the preceding calendar year to the Secretary in a format specified by the Secretary by the twentieth (20°) day of January and additional reports at such times the Secretary judges necessary setting out the quantity of waste generated during a particular time period and the disposition ofthe infectious medical waste. Transporters shall submit these reports on a quarterly basis. A late fee of $25.00 or 10% ofthe permit fee, which is ever greater, will be assessed to those facilities that fail to submit a required annual report on or before the twentieth (20th) day of January of each year.

§64-56-14. Inspections; Right of Entry; Sampling; Reports and Analyses; Subpoenas.

Inspections and other monitoring activities are required to be conducted according to the provisions of N Va. Code §§ 22-18-13 and 20-5J-7 which are outlined in this section.

14.1. Upon the presentation of proper credentials and at reasonable times, the Secretary has the authority to enter any building, property, premises, place, vehicle or permitted facility where infectious medical waste is or has been generated, handled, treated, stored, transported or disposed of for the purpose of promptly investigating any person’s compliance with the provisions of relevant State law, this rule or permits issued under this rule.

14.2. The Secretary is required to make periodic inspections of every permitted facility as necessary to effectively implement and enforce the requirements of relevant State law, this rule or permits issued in accordance with this rule. After an inspection is made, a report is to be prepared and filed with the Secretary. A copy ofthe inspection report is required to be promptly furnished to the person in charge ofthe building, property, premises, place, vehicle or facility. All inspection re- ports are available to the public in accordance with the provisions of N Va. Code § 29B-1-1 et seq.

14.3. Whenever the Secretary has cause to believe that any person is in violation of any provision of relevant State law, this rule, any condition of a permit issued by the Secretary, or any order issued under this rule, he or she is required to immediately order an inspection of the building, property, premises, place, vehicle or permitted facility at which the alleged violation is occurring.

14.4. Upon presentation of proper credentials and at reasonable times, the Secretary has the authority to enter any establishment, building, property, premises, vehicle or other place maintained by any person where infectious medical waste is being or has been generated, transported, stored, treated or disposed of to inspect and take samples of wastes and the contents of any containers or

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64CSR56 labeling for such wastes. A receipt describing such samples, and, if requested, a portion of such sample equal in volume or weight to the portion retained is to be given to the owner, operator or agent in charge prior to the sample being taken from the premises. The Secretary is required to provide a copy of any analysis to the owner, operator or agent in charge promptly.

14.5. Upon presentation of proper credentials and at reasonable times, the Secretary is to be given access to all records relating to the generation, transportation, storage, treatment or disposal of infectious medical waste in the possession of any person who generates, stores, treats, transports, disposes of, or otherwise handles or has handled such waste. The Secretary is to be furnished with copies of all such records or given the records for the purpose of making copies. If the Secretary, upon inspection, investigation or through other means, observes or learns of a violation or probable violation of relevant State law or this rule, he or she is authorized to issue subpoenas and subpoenas duces tecum and to order the attendance and testimony of witnesses and to compel the production of any books, papers, documents, manifests and other physical evidence pertinent to such investigation or inspection.

§64-56-15. Enforcement Orders; Related Hearings; Permit Reinstatement.

Enforcement orders and related hearings are required to be conducted according to the provisions of N Va. Code §§ 22-18-15, 20-5J-8 and 29A-5-1 et. seq. as outlined in Sections 15.1 and 15.2 of this rule.

15.1. If the Secretary, upon inspection, investigation or through other means observes, discovers or learns of a violation of the provisions ofthis rule or relevant State law or of any order or permit issued under this rule or such law by the Secretary, he or she may:

15.1.a. Issue an order stating with reasonable specificity the nature of the violation and requiring compliance immediately or within a specified time. An order under this section includes, but is not limited to, any or all ofthe following: orders suspending, modifying or revoking permits, orders requiring a person to take remedial action, or cease and desist orders;

15.1.b. Seek an injunction in accordance with N Va. Code § 20-5J-9(b);

15.1.c. Institute a civil action in accordance with N Va. Code § 20-5J-9(a); or

15.1.d. Request the attorney general or the prosecuting attorney ofthe county in which the alleged violation occurred to bring a criminal action in accordance with Y. Va. Code § 22-18-16.

15.2. Any person issued a cease and desist order may file a notice of request for reconsideration with the Secretary not more than seven (7) days from the issuance of such order and shall have a hearing before the Secretary contesting the terms and conditions of such order within ten(10) days of the filing of such notice of a request for reconsideration. The hearing is conducted as required by State law and Section 19 ofthis rule. The filing of a notice of request for reconsideration shall not stay or suspend the execution or enforcement of such cease and desist order.

15.3. Any person whose permit issued under this rule has been suspended or revoked may, at any time, make application for reinstatement ofthe permit. After receipt of a written request, including a signed statement by the applicant that in his or her opinion the conditions causing the suspension of

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64CSR56 the permit have been corrected, the Secretary shall make an inspection or investigation of the applicant’s operation. If the applicant complies with the provisions of this rule, the permit shall be reinstated.

15.4. The Secretary may suspend or revoke a permit if the permit has been obtained by means of fraud, deceit or material misrepresentation.

§64-56-16. Criminal Penalties.

In addition to any civil penalties that may be assessed pursuant to section 17, violations of this rule may be subject to criminal penalties pursuant to the provisions of N Va. Code § 22-18-16.

§64-56-17. Civil Penalties.

In addition to any criminal penalties for violations of this rule as provided in section 16, violations ofthis rule may also be subject to civil penalties pursuant to the provisions of V. Va. Code §§ 22-18-17 and 20-5J-9.

§64-56-18. Imminent and Substantial Hazards; Orders; Penalties; Hearings.

18.1. Notwithstanding any provision of this rule to the contrary, the Secretary, upon receipt of information, or upon observation or discovery that the handling, storage, transportation, treatment or disposal of any infectious medical waste may present an imminent and substantial endangerment to public health, safety or the environment, has the authority to:

18.1.a. Request the attorney general or the appropriate prosecuting attorney to commence an action in the circuit court of the county in which the hazardous condition exists to immediately restrain any person contributing to such handling, storage, transportation, treatment or disposal to stop such handling, storage, transportation, treatment or disposal or to take such other action as may be necessary; or

18.1.b. Take other action under this section including, but not limited to issuing such orders as may be necessary to protect public health and the environment.

18.2. Any person who willfully violates, or fails or refuses to comply with, any order of the Secretary under Section 18.1 ofthis rule may, in an action brought in the appropriate circuit court to enforce such orders, be fined not more than five thousand dollars ($5,000) for each day in which such violation occurs or such failure to comply continues.

§64-56-19. Administrative Due Process.

Except for an civil administrative penalty assessed pursuant toF Ka. Code § 22-18-17, persons adversely affected by the enforcement ofthis rule who desire a contested case hearing to determine any rights, duties, interests or privileges, must do so in a manner prescribed in Rules of Procedure for Contested Case Hearings and Declaratory Rulings, 64CSR1.

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TABLE 64-56A

ANNUAL INFECTIOUS MEDICAL WASTE MANAGEMENT FACILITY PERMIT AND OPERATOR REGISTRATION FEES

Tvpe of Facility Fee

A. Hospitals (Non-Commercial Treatment Facilities)

1 to 50 Beds 51 to 149 Beds 150 or More Beds

B. Commercial Infectious Medical Waste Management Facility

Small Commercial Infectious Medical Waste Management Facility for Sharps Only (As provided for in Section 11.19 of this rule)

C. Transportation Vehicles (Each)

D. Commercial Storage and Transfer Facility.

E. Other (Generating more than 50 pounds per month)

1. Health Care Professionals 2. Independent Dialysis Centers 3. Independent Laboratories 4. Independent Rural Clinics 5. Nursing Homes 6. Other Long Term Care Facilities 7. Outpatient Surgery Centers

F. Incinerator Operator Registration

G. Alternative treatment evaluation fee

Wyoming Medical Waste Regulations

Wyoming’s medical waste disposal regulations are managed by the Wyoming Department of Environmental Quality.

As of December 2021, there are no specific rules or guidelines for the handling, storage, treatment, and disposal of medical or infectious waste at the state level. State regulations mention medical waste as in incinerators, and in the solid waste management general provisions but lack any specific guidance.


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