DRAFT -- Model Medical Waste Law

MODEL MEDICAL WASTE LAW

ARTICLE I - APPLICATION AND DEFINITIONS

Section 1. Application

This statute applies to all persons who generate, collect, receive, store, transport, haul, treat, dispose, or handle medical waste in any form, except that this statute does not apply to individuals, such as diabetic patients, who only generate medical waste solely as a result of administering their own medical treatment.

Section 2. Definitions

(a) “Biohazard bag” means a disposable red bag which is impervious to moisture and has a strength sufficient to preclude ripping, tearing, or bursting under normal conditions of usage and handling of the waste-filled bag.

(b) “Container” means a biohazard bag or rigid container in which medical waste is placed.

(c) “Enforcement agency” means the department or the local agency administering this statute.

(d) “Enforcement officer” means any agent, representative, director or employee, including environmental health specialists and local health officers, of the enforcement agency.

(e) “Household waste” means any material, including garbage, and trash which is derived from households, farms, or ranches.

(f) “Infectious agent” means a type of microorganism, bacteria, mold, parasite, or virus which normally causes, or significantly contributes to the cause of, increased morbidity or mortality of human beings.

(g) “Infectious waste” means waste capable of producing an infectious disease. Infectious waste includes any of the following:

(1) Laboratory waste, including, but not limited to, all of the following: (A) Human or animal specimen cultures from medical and pathological laboratories; (B) Cultures and stocks of infectious agents from research and industrial laboratories; (C) Wastes from the production of bacteria, viruses, or the use of spores, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate, and mix cultures; or (D) Waste containing any microbiological specimens sent to a laboratory for analysis.

(2) Human surgery specimens or tissues removed at surgery or autopsy, which are suspected by the attending physician and surgeon or dentist of being contaminated with infectious agents.

(3) Animal parts, tissues, fluids, or carcasses suspected by the attending veterinarian of being contaminated with infectious agents.

(4) Waste, which at the point of transport from the generator’s site, at the point of disposal, or thereafter, contains recognizable fluid blood, fluid blood products, containers, or equipment containing blood that is fluid or blood from animals known to be infected with diseases which are communicable to humans.

(5) Waste containing discarded materials contaminated with excretion, exudate, or secretions from humans who are required to be isolated by the infection control staff, the attending physician and surgeon, the attending veterinarian, or the local health officer, to protect others from highly communicable diseases or isolated animals known to be infected with diseases which are highly communicable to humans.

(h)(1) “Medical waste” means infectious waste or sharps waste that is generated or produced as a result of the diagnosis, treatment, or immunization of human beings or animals, or in research pertaining thereto, or in the production or testing of biologicals.

(2) Medical waste does not include any of the following: (A) Waste containing microbiological cultures not considered to be infectious agents; (B) Waste which is not infectious, such as articles containing non-fluid blood, and other medical solid waste products commonly found in the facilities of medical waste generators; (C) Radioactive waste; (D) Household waste; (E) Waste generated from normal and legal veterinarian, agricultural, and animal livestock management practices on a farm or ranch.

(i) “Medical waste generator” means any person, whose acts or processes produce medical waste and includes, but is not limited to, a provider of health care. All of the following are examples of medical waste generators:

(1) Medical and dental offices, clinic, hospitals, surgery centers, laboratories, research laboratories.

(2) Veterinary offices, clinics, and hospitals.

(3) “Large-quantity generator” means a medical waste generator that generates 200 or more pounds per month of medical waste.

(4) “Small-quantity generator” means a medical waste generator that generates less than 200 pounds per month of medical waste.

(j) “Medical waste hauler” means any person who transports medical waste. Medical waste generators who transport their own medical waste are also medical waste haulers.

(k) “Medical waste transfer station” means any person who receives but does not treat medical waste. Medical waste haulers who store medical waste are also medical waste transfer stations.

(l) “Medical waste treatment facility” means any person who treats medical waste. Medical waste generators who treat medical waste are also medical waste treatment facilities.

(m) “Person” means an individual, trust, firm, joint stock company, business concern, partnership, association, or corporation, including, but not limited to, a government corporation. “Person” also includes any city, county, district, commission, the state or any department, agency, or political subdivision thereof, any interstate body, and the federal government or any department or agency thereof.

(n) “Sharps container” means a rigid puncture-resistant container which, when sealed, is leak resistant and cannot be reopened without great difficulty.

(o) “Sharps waste” means any device having acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, all of the following:

(1) Hypodermic needles, syringes, blades, and needles with or without attached tubing; and

(2) Broken glass items, such as Pasteur pipettes and blood vials contaminated with medical waste.

(p) “Storage” means the holding of medical wastes.

(q) “Tracking document” means the medical waste tracking document specified in Section 14.

(r) “Treatment” means any method, technique, or process designed to change the biological character or composition of any medical waste so as to eliminate its potential for causing disease.

ARTICLE 2 - REQUIREMENTS APPLICABLE TO ALL PERSONS

Section 3. Segregation

All persons shall, at the point of generation and at all times thereafter, segregate medical waste from other (non-medical) waste. No person shall mix medical waste with non-medical wastes.

Section 4. Packing

(a)(1) All persons shall place solid or semi-solid infectious waste, such as animal carcases, human body parts, and laboratory wastes in one or more red biohazard bags conspicuously labeled with the words “Infectious Waste” or with the international biohazard symbol and the word ABIOHAZARD.”

(2) All persons shall tie biohazard bags when full to prevent leakage or expulsion of contents during handling, storage or transport.

(3) No person shall remove infectious wastes from a biohazard bag until after the waste is treated.

(4) All persons shall place biohazard bags containing infectious waste in one or more rigid containers prior to storage or transport. Rigid containers shall be leak resistant, have tight fitting covers, and be kept clean and in good repair. Containers shall be labeled with the words "Infectious Waste,” or with the international biohazard symbol and the word ABIOHAZARD,” on the lid and on the sides so as to be visible from any direction.

(b) All persons shall place liquid infectious waste in capped or tightly stoppered bottles, flasks or containment tanks (for large quantities of liquid waste). Such bottles, flasks or tanks shall be conspicuously labeled with the words “Infectious Waste” or with the international biohazard symbol and the word ABIOHAZARD.”

(c) All persons shall, at the point of generation and at all times thereafter, place and keep sharps waste in a sharps container. When full, sharps containers shall be taped closed or shall be tightly fastened with a lid to prevent the release of any sharps waste from the container. Sharps containers shall be labeled with the words "sharps waste” or with the international biohazard symbol and the word ABIOHAZARD.” Sharps containers may be placed in biohazard bags or in containers with biohazard bags.
Section 5. Storage

(a) No person shall store infectious waste above 0oC for more than seven days without the written approval of the enforcement agency. No person shall store infectious waste for more than 90 days before treatment without the written approval of the enforcement agency. If the person is unable to control the odor from its stored waste and the odor poses a public nuisance, the enforcement agency may require more frequent removal. In no event may a person store any medical waste for more than one year.

(b) All persons shall secure any area used for the storage of medical waste containers so as to deny access to unauthorized persons. Storage areas shall be marked with warning signs on, or adjacent to, the exterior of entry doors, gates, or lids. Storage areas may be secured by use of locks on entry doors, gates, or receptacle lids. Storage areas shall be maintained so as to prevent the entry of animals and natural elements and to prevent breeding places or a food source for insects or rodents.

Section 6. Treatment

All persons treating medical wastes shall do so only by one or more of the following methods:

(a) Steam sterilization or other sterilization at a permitted medical waste treatment facility in accordance with all of the following standards:

(1) Written operating procedures shall be established for biological indicators, or for other indicators, of adequate sterilization approved by the department, for each steam sterilizer, including time, temperature, pressure, type of waste, type of container, closure on container, pattern of loading, water content, and maximum load quantity.

(2) Recording or indicating thermometers shall be checked during each complete cycle to ensure the attainment of 121oC for at least one-half hour, depending on the quantity and density of the load, in order to achieve sterilization of the entire load. Thermometers shall be checked for calibration annually. Records of the calibration checks shall be maintained as part of the facility=s files and records for a period of three years.

(3) Heat-sensitive tape, or another method acceptable to the enforcement agency, shall be used on each container that is processed to indicate the attainment of adequate sterilization conditions.

(4) The biological indicator Bacillus stearothermophilus, or other indicator of adequate sterilization as approved by the department, shall be placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

(5) Records of the procedures specified in paragraphs (1), (2), and (4) shall be maintained for a period of not less than three years.

(b) Microwaving at a permitted medical waste treatment facility in accordance with all of the following standards:

(1) Microwave treatment shall not be used for cytotoxic, hazardous or radioactive wastes, contaminated animal carcasses, human body parts and large metal items.

(2) The microwave system shall comply with the efficacy test/routine tests and a performance guarantee must be provided by the supplier before operation of the unit.

(3) The biological indicator Bacillus stearothermophilus, or other indicator of adequate sterilization as approved by the department, shall be placed at the center of a load processed under standard operating conditions at least monthly to confirm the attainment of adequate sterilization conditions.

(4) Records of the procedures specified in paragraphs (2) and (3) shall be maintained for a period of not less than three years.

(c) For human anatomical wastes and animal wastes ONLY - deep burial at a permitted medical waste treatment facility in accordance with all of the following standards:

(1) A pit or trench shall be dug 2 or more meters deep. The pit or trench shall be half filled with waste, then covered with lime to within 50 centimeters of the surface before filling the rest of the pit or trench with soil.

(2) On each occasion, when wastes are added to the pit or trench, a layer of 10 centimeters of soil shall be added to cover the wastes.

(3) Burial shall be closely supervised by trained personnel.

(4) It must be ensured that animals do not have any access to burial sites. Covers of galvanized iron/wire meshes may be used.

(5) Burial sites shall be relatively impermeable and not within 50 meters of any shallow well.

(6) Burial sites shall be not within 200 meters from any habitation, and sited so as to ensure that no contamination occurs of any surface water or ground water. Burial sites shall not be prone to flooding or erosion.

(7) The location of all burial sites shall be recorded and permanently maintained.

(d) For animal body parts and carcasses and recognizable human anatomical remains ONLY - incineration at a permitted medical waste treatment facility in accordance with all of the following standards:

(1) Incineration shall be conducted in an enclosed combustion chamber, such as a furnace. No open burning is permitted.

(2) Incineration shall not take place within 500 meters of any habitation, and sited so as to ensure that no emissions adversely impact human health.

(e) The enforcement agency may approve alternative medical waste treatment methods that result in the destruction of pathogenic microorganisms without posing a risk to human health or the environment.

Section 7: Phase-out of Medical Waste Incineration

Except as provided in Section 6(d) no person may incinerate medical waste except that, prior to three years after the enactment of this statute, persons may incinerate only infectious medical waste at a permitted medical waste treatment facility in accordance with all of the following standards:

(1) (A) Combustion efficiency (CE) shall be at least 99.9%. Combustion efficiency shall be computed as follows: CE = %CO2/%CO2 +%CO x 100; (B) The temperature of the primary chamber shall be 800 + 50oC; (C) The secondary chamber gas residence time shall be at least one (1) second at 1050 + 50oC, with minimum 3% oxygen in the stack gas; (D) Minimum stack height shall be 30 meters above ground.

(2) (A) Exhaust gas shall not contain more than 150 mg of particulate matter per normal cubic meter (mg/Nm3) at (12% CO2 correction); (B) Exhaust gas shall not contain not more than 450 mg/Nm3 of nitrogen oxides at (12% CO2 correction); (C) Exhaust gas shall not contain more than 50 mg/Nm3 of HCl at (12% CO2 correction); (D) Volatile organic compounds in ash shall not be more than 0.01%.

Section 8. Disposal

(a) All persons shall dispose of treated medical waste in a manner, which does not cause harm to the public health or the environment. Medical waste, which has been effectively treated, may be mixed with ordinary waste, unless the medical waste is otherwise hazardous because of its toxicity.

(a) All persons shall consider the following options for the disposal of treated medical waste:

(1) For treated medical wastes that are solid or semi-solid after treatment - disposal in a sanitary landfill.

(2) For treated medical wastes that are liquid after treatment - discharge to a public sewage system in a manner that complies with all applicable wastewater discharge requirements.

(c) No person shall dispose of to a landfill treated medical wastes that are liquid after treatment.

ARTICLE 3 - ADDITIONAL REQUIREMENTS APPLICABLE TO MEDICAL WASTE GENERATORS

Section 9. Registration

(a) Within ninety days after the enactment of this statute, every medical waste generator shall register with the enforcement agency. Registration shall be accomplished by submitting to the enforcement agency an application, on forms prescribed by the enforcement agency, containing the following information:

(1) The name of the person.

(2) The business address of the person.

(3) The type of business.

(4) The types, and the estimated average monthly quantity, of medical waste generated.

(5) The type of treatment used onsite, if any, and the capacity of such onsite treatment.

(6) The name of the medical waste hauler(s), if any, transporting medical waste from the medical waste generator.

(7) The name and location of offsite medical waste treatment facilities, if any, treating medical waste from the medical waste generator.

(8) A statement certifying that the information provided is complete and accurate.

(b) Registration shall be valid for one year for large-quantity medical waste generators and for two years for small-quantity medical waste generators.

(c) Small-quantity medical waste generators shall file an application for renewal of the registration with the enforcement agency on or before the expiration date. Large generators shall file an application for renewal with the enforcement agency not less than 90 days prior to the expiration date. Failure to meet this requirement shall result in an assessment of a late fee.

(d) Generators shall submit, within 30 days, an updated application form when any of the information specified in paragraph (a) changes.

Section 10. General Requirements

(a) Ninety days after the enactment of this statute, no medical waste generator shall operate without a valid registration.

(b) Medical waste generators must segregate, pack and store medical waste in strict conformance with sections 3, 4, and 5 of Article 2.

(c) Medical waste generators must treat and dispose of medical waste in strict conformance with sections 6, 7, and 8 of Article 2 or make arrangements with a medical waste hauler to transport such medical waste to a permitted medical waste treatment facility.

(d) Medical waste generators shall not release medical waste to a medical waste hauler until first: (A) making reasonably certain that the medical waste hauler is registered with the enforcement agency; and (B) obtaining a tracking document for each shipment of medical waste.

Section 11. Medical Waste Reduction Plans, Progress Reports

(a) Within one year after enactment of this statute, each medical waste generator shall prepare a Medical Waste Reduction Plan, which evaluates ways to reduce the volume of medical waste that is produced by the generator, and submit such plans to the enforcement agency. The generator shall consider the quantity of waste, the hazardous properties of the waste, the safety of its patients and employees, economic costs and savings, and other appropriate factors in developing a plan. At a minimum, each plan shall include:

(1) The scope and objectives of the plan, including evaluation of technologies, procedures, and personnel training programs that reduce unnecessary medical waste generation. The specific goal of the plan shall be to reduce the amount of medical waste by twenty-five percent in four years;

(2) Analysis of medical waste streams that identify individual processes or facilities and other activities where medical waste may be generated and identify opportunities to reduce or eliminate medical waste generation. Such assessments shall evaluate data on the types, amount, and hazardous constituents of medical waste generated, where and why that medical waste was generated, and potential medical waste reduction and recycling techniques applicable to those medical wastes;

(3) Employee awareness and training programs that involve employees in medical waste reduction planning and implementation to the maximum extent feasible; and

(4) Measures to implement medical waste reduction options into management practices and procedures;

(5) Responses to comments from the public.

(b) The enforcement agency shall afford the public an opportunity to comment on each plan submitted.

(1) Prior to final adoption, the enforcement agency shall provide timely notice to the public of all plans submitted. The notice shall appear in local newspaper(s) and in the local language(s). The notice shall include: (A) The name of the generator; the business address of the generator; (B) a location where members of the public can view the plan; and (C) an address and telephone number that members of the public can use to comment on the permit application.

(2) The enforcement agency shall provide 30 days after issuing notice for the receipt of comments from the public. Any person may submit oral or written statements and data concerning the permit application. The public comment period shall be extended to the close of any public hearing granted under this section.

(3) For plans submitted by large-quantity generators, the enforcement agency shall convene a public hearing whenever more than five persons request one. A request for a public hearing shall be in writing and shall state the nature of the issues proposed to be raised in the hearing. Notice of a public hearing shall appear in local newspaper(s) and in the local language(s) at least 30 days before the hearing and shall contain the following information: (A) The date, time, and place of the hearing; and (B) A brief description of the nature and purpose of the hearing.

(4) The enforcement agency shall transmit any public comments it receives to the generator that submitted the plan.

(c) Once every year, each medical waste generator shall submit a Medical Waste Reduction Progress Report to the enforcement agency. The report shall include all of the following:

(1) The name and location of the generator;

(2) An estimate of the quantity of medical waste generated and the quantity of medical waste treated, both onsite and offsite, during the current reporting year;

(3) An assessment of the effect, during the current year, of each medical waste reduction measure implemented upon the generation and the onsite and offsite management of medical waste.

(4) A description of factors during the current reporting year that have affected medical waste generation and onsite or offsite medical waste treatment.

ARTICLE 4 - ADDITIONAL REQUIREMENTS APPLICABLE TO MEDICAL WASTE HAULERS

Section 12. Registration

(a) Within 60 days after enactment of this statute, every medical waste hauler shall register with the enforcement agency. Registration shall be accomplished by submitting to the enforcement agency an application, on forms prescribed by the enforcement agency, containing the following information:

(1) The name of the person;

(2) The business address of the person;

(3) The types, and the estimated average monthly quantity, of untreated medical waste hauled;

(4) The name and location of medical waste treatment facilities to which the medical waste hauler brings untreated medical waste; and

(5) A statement certifying that the information provided is complete and accurate.

(b) Registration shall be valid for two years.

(c) Medical waste haulers shall file an application for renewal of the registration with the enforcement agency on or before the expiration date.

(d) Medical waste haulers shall submit, within 30 days, an updated application form when any of the information specified in paragraph (a) changes.

(e) Ninety days after the enactment of this statute, no medical waste hauler shall operate without a valid registration.

Section 13. Transportation requirements

(a) At the beginning of each shift, medical waste haulers shall provide and require all persons manually loading or unloading containers of untreated medical waste to wear clean, protective gloves and coveralls, changeable lab coats, or other protective clothing. The enforcement agency may require, by regulation, other protective devices appropriate to the type of untreated medical waste being handled.

(b) Medical waste haulers shall transport untreated medical waste in leak-resistant and fully-enclosed rigid containers in vehicle compartments.

(c) Medical waste haulers shall not transport untreated medical waste in the same vehicle with other waste unless the untreated medical waste is separately contained in rigid containers or kept separate by barriers from other waste.

(d) Medical waste haulers shall transport untreated medical waste only to:

(1) a permitted medical waste treatment facility; or

(2) a registered medical waste transfer station for the purpose of consolidating untreated medical waste prior to its ultimate transport to a permitted medical waste treatment facility.

Section 14. Tracking documents

(a) A medical waste hauler shall maintain completed tracking documents for all medical waste it transports. At the time the medical waste hauler receives medical waste from any person, the hauler shall provide that person with a copy of the tracking document for that person=s medical waste records. The hauler shall maintain a copy of such tracking documents for a minimum of three years. The hauler shall submit to the enforcement agency, upon request, copies of any tracking documents the hauler is required to maintain.

(b) The tracking document shall include, but not be limited to, all of the following information:

(1) The name, address, and telephone number of the hauler.

(2) The name, address, telephone number, and the signature of an authorized representative of the person from which the medical waste was received.

(3) The date the medical waste was received.

(4) The type and quantity of medical waste received.

(5) The name, address, telephone number, and the signature of an authorized representative of the person to which the medical waste was transported.

(c) Any medical waste hauler transporting medical waste in a vehicle shall have a tracking document in his or her possession while transporting the waste. The tracking document shall be shown upon demand to any enforcement agency personnel or any law enforcement officer. If the waste is transported by rail, vessel, or air, the railroad corporation, vessel operator, or airline shall enter on the shipping papers any information concerning the waste, which the enforcement agency may require.

(d) A medical waste hauler shall provide the person receiving the medical waste with the original tracking document.

ARTICLE 5 - ADDITIONAL REQUIREMENTS APPLICABLE TO MEDICAL WASTE TRANSFER STATIONS

Section 15. Registration

(a) Within 60 days after enactment of this statute, every medical waste transfer station shall register with the enforcement agency. Registration shall be accomplished by submitting to the enforcement agency an application, on forms prescribed by the enforcement agency, containing the following information:

(1) The name of the person;

(2) The business address of the person;

(3) The types, and the estimated average monthly quantity, of untreated medical waste stored and transferred;

(4) The name and location of medical waste treatment facilities to which the medical waste transfer station transfers untreated medical waste;

(5) The name of the medical waste hauler(s) transporting medical waste from the medical waste transfer station; and

(6) A statement certifying that the information provided is complete and accurate.

(b) Registration shall be valid for two years.

(c) Medical waste transfer stations shall file an application for renewal of the registration with the enforcement agency on or before the expiration date.

(d) Medical waste transfer stations shall submit, within 30 days, an updated application form when any of the information specified in paragraph (a) changes.

(e) Ninety days after the enactment of this statute, no medical waste transfer station shall operate without a valid registration.

Section 16. Storage

A medical waste transfer station shall insure that all untreated medical waste is stored in strict conformance with the requirements of section 5.

Section 17. Record Keeping

Medical waste transfer stations shall maintain, for a minimum of three years and shall submit to the enforcement agency, upon request, copies of the tracking documents for all medical waste it receives for storage from medical waste haulers and for all medical waste that is transported by medical waste haulers to a medical waste treatment facility.

ARTICLE 6 - ADDITIONAL REQUIREMENTS APPLICABLE TO PERSONS OPERATING MEDICAL WASTE TREATMENT FACILITIES

Section 18. Permits

(a) Any person operating a medical waste treatment facility must obtain, within 6 months after the enactment of this statute, a permit from the enforcement agency. A permit shall be obtained by filing with the enforcement agency, on forms prescribed by it, an application containing all of the following information:

(1) The name of the applicant.

(2) The business address of the applicant.

(3) The type of treatment provided, the treatment capacity of the facility, a characterization of the waste treated at this facility, and the estimated average monthly quantity of waste treated at the facility.

(4) Evidence satisfactory to the enforcement agency that the operator of the medical waste treatment facility has the ability to comply with the provisions of this statute.

(5) For an applicant who has owned or operated a facility permitted by the enforcement agency, a description of all violations which occurred at any such facility in the three years prior to the date of application.

(6) Any other information required by the enforcement agency for the administration or enforcement of this statue.

(b) (1) The enforcement agency shall provide timely notice to the public of all applications for a permit. The notice shall appear in local newspaper(s) and in the local language(s). The notice shall include: (A) The name of the applicant; (B) The business address of the applicant; (C) The type of treatment provided, the treatment capacity of the facility, a characterization of the waste treated at this facility, and the estimated average monthly quantity of waste treated at the facility; (D) a location where members of the public can view the permit application; and (E) an address and telephone number that members of the public can use to comment on the permit application.

(2) The enforcement agency shall provide 30 days after issuing notice of the permit application for the receipt of comments from the public. Any person may submit oral or written statements and data concerning the permit application. The public comment period shall automatically be extended to five days after the close of any public hearing granted under this section.

(3) The enforcement agency shall convene a public hearing to receive comments on a permit application whenever more than five persons request one. A request for a public hearing shall be in writing and shall state the nature of the issues proposed to be raised in the hearing. Notice of a public hearing shall appear in local newspaper(s) and in the local language(s) at least 30 days before the hearing and shall contain the following information: (A) The Date, time, and place of the hearing; (B) A brief description of the nature and purpose of the hearing; and (C) A summary of major issues raised to date during the public comment period.

(c) Prior to issuing or renewing a permit, the enforcement agency shall review the compliance history of the applicant, under any local, state, or federal laws governing medical waste or pollution. The enforcement agency shall deny a permit, or specify additional permit conditions, if the enforcement agency determines that in the three-year period preceding the date of application the applicant has violated laws or regulations governing medical waste or pollution at a facility owned or operated by the applicant and the violations demonstrate a recurring pattern of noncompliance or pose, or have posed, a significant risk to public health and safety or to the environment.

(1) In making a decision whether to grant or deny a permit, the enforcement agency shall consider, among other factors it considers relevant: (A) Whether granting the permit would result in a risk of harm to the public health or the environment; (B) The present and future ability of the applicant to safely operate the facility in compliance with all the provisions of this statute; and (C) the compliance history of the applicant with any local, state, or federal laws governing medical waste or pollution.

(2) The enforcement agency may impose reasonable permit conditions necessary to facilitate the applicant=s compliance with the provisions of this statute.

(3) The enforcement agency shall provide the applicant, and members of the public who commented on the application, notice of the enforcement agency`s decision to grant or deny a permit or to impose permit conditions. Such notice shall be in writing and include a concise statement expressing the enforcement agency=s reasons for granting or denying the permit or imposing permit conditions.

(d) A permit shall be valid for five years. An application for renewal of the permit shall be filed with the enforcement agency not less than 90 days prior to the expiration date. If a permit holder fails to make a timely application for renewal, the medical waste permit shall expire on the expiration date. A permit shall terminate prior to its expiration date if either of the following occurs:

(1) The permit holder sells or otherwise transfers the facility.

(2) The permit holder surrenders the permit to the enforcement agency because the permit holder ceases operation.

(e) The enforcement agency may suspend, amend, or revoke any permit if the permit holder:

(1) Violates any provision of this statute.

(2) Violates any term or condition of the permit.

(3) Interferes with the performance of the duties of the enforcement officer.

(4) Intentionally makes false statements or fails to disclose fully all relevant facts, in any material regard, on an application for a permit.

(5) Is convicted of any crime which is substantially related to the qualifications or duties of the permit holder or which is substantially related to the functions, which are subject to the permit. For purposes of this section, a conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to revoke or suspend the permit may be taken when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal. That action may also be taken when an order granting probation is made suspending the imposition of sentence. The enforcement agency shall take into account evidence of rehabilitation furnished by the permit holder or person in charge of the permitted activity.

(6) A change in any a condition that requires a temporary or permanent modification, reduction, or termination of the permitted operation to bring it into compliance with the requirements of this statute.

(f) The enforcement agency may temporarily suspend a permit prior to any hearing, when it has determined that this action is necessary to protect the public welfare. The enforcement agency shall notify the permit holder of the temporary suspension and the effective date thereof and, at the same time, shall serve the permit holder with an accusation. Upon receipt of a notice of defense by the permit holder, the matter shall, within 15 days, be set for hearing. The hearing shall be held as soon as possible, but not later than 30 days after receipt of the notice. The temporary suspension shall remain in effect until the hearing is completed and the enforcement agency has made a final determination on the merits. However, the temporary suspension is vacated if the enforcement agency fails to make a final determination on the merits within 60 days after the original hearing has been completed.

Section 19. Record keeping

Medical waste treatment facilities shall maintain, for the prescribed times, and shall submit to the enforcement agency, upon request, all of the following:

(a) Treatment operating records required to be kept by the facility for a minimum of three years under sections 6(a)(5) and 6(b)(4)

(b) The location of burial sites required to be kept by the facility permanently under section 6(c)(7).

(c) Copies of the tracking documents for all medical waste it receives from medical waste haulers.

ARTICLE 7 - ENFORCEMENT

Section 20. Inspections

(a) In order to carry out the purposes of this statute, any authorized representative of the enforcement agency may do any of the following:

(1) Enter and inspect the premises of any medical waste generator, medical waste hauler, medical waste transfer station, or medical waste treatment facility.

(2) Enter and inspect a vehicle of a medical waste hauler.

(3) Inspect and copy any records, reports, test results, or other information related to the requirements of this statute or the regulations adopted pursuant to this statute.

(b) The inspection shall be made with the consent of the person or, if consent is refused, with a warrant duly issued. However, in the event of an emergency affecting the public health or safety, an inspection may be made without consent or the issuance of a warrant.

Section 21. Compliance orders, administrative penalties

(a) Whenever the enforcement agency determines that a violation or threatened violation of this statute has resulted or is likely to result, the agency may issue an order to the responsible person specifying a schedule of actions necessary for compliance or requiring the responsible person to cease and desist generating medical waste, receiving medical waste for transport, transporting medical waste, receiving medical waste for storage, storing medical waste, receiving medical waste for treatment, or treating medical waste.

(b) After notice and an opportunity for hearing, the enforcement agency may impose an administrative penalty of not more than ten thousand dollars ($10,000) per violation on any person who violates an order issued pursuant to this section.

(c) After notice and an opportunity for hearing, the enforcement agency may impose an administrative penalty of not more than one thousand dollars ($1,000) for each day:

(1) a medical waste generator fails to register with the enforcement agency;

(2) a medical waste hauler fails to register with the enforcement agency;

(3) a medical waste transfer station fails to register with the enforcement agency; or

(4) a medical waste treatment facility operates without a permit from the enforcement agency.

Section 22. Civil actions

(a) An enforcement agency may bring an action to stop a violation, or threatened violation, of this statute in a competent court in the location in which the violation occurred or is about to occur. The enforcement agency is not required to allege facts necessary to show or tending to show the lack of an adequate remedy at law or irreparable damage or loss in any such proceedings.

(b) The court shall, if it finds in favor of the enforcement agency, issue an order stopping the continuance of the violation and may assess the following civil penalties:

(1) A penalty of not more than ten thousand dollars ($10,000) per violation on any person who violates a provision of sections 3, 4, 5, 6, 7, 8, 10, 13, 14, 16, 17, or 19, or an order issued pursuant to section 21.

(2) A penalty of not more than one thousand dollars ($1,000) for each day: (A) a medical waste generator fails to register with the enforcement agency; (B) a medical waste hauler fails to register with the enforcement agency; (C) a medical waste transfer station fails to register with the enforcement agency; or (D) a medical waste treatment facility operates without a permit from the enforcement agency.

Section 23. Criminal liability

(a) Notwithstanding paragraphs (b) and (c), any person who violates any provision of this statute, a condition of a permit held by a medical waste treatment facility, or an order of the enforcement agency, is guilty of a public offense as follows:

(1) For a small-quantity medical waste generator, a first offense is an infraction and is punishable by a fine of not more than one thousand dollars ($1,000).

(2) For a person other than a small-quantity medical waste generator, a first offense is a misdemeanor punishable by a fine of not less than two thousand dollars ($2,000), or by up to one year in jail, or by both the fine and imprisonment.

(3) A person who is convicted of a second or subsequent violation within three years of the prior conviction shall be punished by imprisonment for not more than three years or by a fine of not less than five thousand dollars ($5,000) or more than twenty-five thousand dollars ($25,000), or by both the fine and imprisonment. This section shall not apply unless any prior conviction is charged in the accusatory pleading and admitted by the defendant or found to be true by the trier of fact.

(b) Any person who knowingly treats or disposes, or causes the treatment or disposal of, medical waste in violation of this statute shall be punished by imprisonment for not less than one year and not more than three years, or by a fine of not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000), or by both the fine and imprisonment.

(c) Any person who intentionally makes any false statement or representation in any application, label, tracking document, record, report, permit, registration, or other document filed, maintained, or used for purposes of compliance with this statute is liable for a civil penalty of not more than ten thousand dollars ($10,000) for each separate violation or, for continuing violations, for each day that the violation continues.

Section 24. Public actions

(a) For purposes of enforcing the provisions of this statute, any person may file an appropriate administrative, civil, or criminal action in the proper forum against:

(1) Any person for failure to comply with any provision of this statute, with the conditions of a permit, or with an order of the enforcement agency;

(2) The enforcement agency or any enforcement officer for failure to perform any act or duty under this statute that is not discretionary; or

(3) However, no person may file an action until thirty days after serving notice on the person(s) against whom an action will be taken. Such notice shall inform the person(s) against whom an action will be taken and the enforcement agency of the nature of the actionable failures of the person, enforcement agency, or enforcement officer.

(b) The court shall exempt public actions from the payment of filing fees. Upon prima facie showing of the failure complained of, the court shall exempt the person who filed the action from the payment of an injunction bond for the issuance of a preliminary injunction.

(c) The court shall, if it finds in favor of the person who filed the action, issue an order stopping the continuance of the violation and may apply the civil penalties of section 22(b).

(d) The court shall, if it finds in favor of the person who filed the action, award costs of litigation (including reasonable attorney and expert witness fees) to the person who filed the action. If the court finds against the person who filed the action, the court shall not award costs of litigation to the person(s) against whom the action was taken unless the action was malicious and/or baseless.

ARTICLE 8 - ACCESS TO INFORMATION

Section 25. Access to records

(a) The enforcement agency shall, in a timely manner, make available on request to any member of the public any record, report or information obtained under this statute except upon a satisfactory showing to the enforcement agency by the entity concerned that the record, report or information, or parts thereof, if made public, would divulge secret methods or processes entitled to protection as intellectual property. Such records and reports include, but are not limited to, the following:

(1) Applications for registration submitted to the enforcement agency by any medical waste generator pursuant to section 9;

(2) Tracking documents submitted by any medical waste generator to the enforcement agency pursuant to section 10;

(3) Medical Waste Reduction Plans and Progress Reports submitted to the enforcement agency by any generator pursuant to section 11;

(4) Applications for registration submitted to the enforcement agency by any medical waste hauler pursuant to section 12;

(5) Tracking documents submitted by any medical waste hauler to the enforcement agency pursuant to section 14;

(6) Applications for registration submitted to the enforcement agency by any medical waste transfer station pursuant to section 15;

(7) Tracking documents submitted by any medical waste transfer station to the enforcement agency pursuant to section 17;

(8) Applications for a permit and any supporting document submitted by any medical waste treatment facility to the enforcement agency pursuant to section 18;

(9) Treatment operating records submitted by any medical waste treatment facility to the enforcement agency pursuant to section 19(a);

(10) Locations of deep burial sites submitted by any medical waste treatment facility to the enforcement agency pursuant to section 19(b);

(11) Tracking documents submitted by any medical waste treatment facility to the enforcement agency pursuant to section 19(c); or

(12) Any order issued by the enforcement agency to any person pursuant to section 20.

Article 9 - JUDICIAL REVIEW

Section 26. Judicial review of enforcement agency actions

(a) Any person may file an action, in a competent court in a location over which the enforcement agency has jurisdiction, seeking judicial review of any of the following actions of the enforcement agency:

(1) the issuance or denial of the issuance of a permit to a medical waste treatment facility under section 18(e), the suspension, amendment, or revocation of a permit under section 18(f), or the temporary suspension of a permit under section 18(g).

(2) the issuance of a compliance order under section 21(a).

(3) the issuance of an administrative penalty under sections 21(b) or 21(c).

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