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Regulatory Affairs - Statute and Regulations

effective 11/23/1993

Title XIII Storage, Treatment and Disposal of Regulated Medical Waste

Statutory Authority: Public Health Law, Section 1389

Section 1389-aa. Definitions.


§ 1389-aa. Definitions.
1. "Regulated medical waste" shall mean any of the following waste which is generated in the diagnosis, treatment or immunization of human beings or animals, in research pertaining thereto, or in production and testing of biologicals, provided, however, that "regulated medical waste" shall not include any hazardous waste identified or listed pursuant to section 27-0903 of the environmental conservation law, or any household waste as defined in regulations promulgated under such section.
(a) Cultures and stocks. This waste shall include cultures and stocks of agents infectious to humans, and associated biologicals, cultures from medical or pathological laboratories, cultures and stocks of infectious agents from research and industrial laboratories, wastes from the production of biologicals, discarded live or attenuated vaccines, or culture dishes and devices used to transfer, inoculate or mix cultures.
(b) Human pathological wastes. This waste shall include tissue, organs, and body parts (except teeth and the contiguous structures of bone and gum), body fluids that are removed during surgery, autopsy, or other medical procedures, or specimens of body fluids and their containers, and discarded material saturated with such body fluids other than urine, provided that the commissioner, by duly promulgated regulation, may exclude such discarded material saturated with body fluids from this definition if the commissioner finds that it does not pose a significant risk to public health. This waste shall not include urine or fecal materials submitted for other than diagnosis of infectious diseases.
(c) Human blood and blood products. This waste shall include:
(i) discarded waste human blood, discarded blood components (e.g. serum and plasma) containers with free flowing blood or blood components or discarded saturated material containing free flowing blood or blood components; and
(ii) materials saturated with blood or blood products provided that the commissioner, by duly promulgated regulation, may exclude such material saturated with blood or blood products from this definition if the commissioner finds that it does not pose a significant risk to public health.
(d) Sharps. This waste shall include but not be limited to discarded unused sharps and sharps used in animal or human patient care, medical research, or clinical or pharmaceutical laboratories, hypodermic, intravenous, or other medical needles, hypodermic or intravenous syringes to which a needle or other sharp is still attached, Pasteur pipettes, scalpel blades, or blood vials. This waste shall include, but not be limited to, other types of broken or unbroken glass (including slides and cover slips) in contact with infectious agents. This waste shall not include those parts of syringes from which sharps are specifically designed to be easily removed and from which sharps have actually been removed, and which are intended for recycling or other disposal, so long as such syringes have not come in contact with infectious agents.
(e) Animal waste. This waste shall mean discarded materials, including carcasses, body parts, body fluids, blood, or bedding originating from animals known to be contaminated with infectious agents or from animals inoculated during research, production of biologicals, or pharmaceutical testing with infectious agents.
(f) Any other waste material containing infectious agents designated by the commissioner as regulated medical waste.
2. "Storage" shall mean the containment of regulated medical waste in such a manner as not to constitute disposal of such waste.
3. "Transport" shall mean the movement of regulated medical waste from the point of generation to any intermediate points and finally to the point of ultimate disposal.
4. "Treatment" shall mean any method, technique or process designed to change the character or composition of any regulated medical waste so as to either neutralize such waste or to render such waste not infectious as approved by the commissioner pursuant to section thirteen hundred eighty-nine-dd of this title.
5. "Infectious agents" shall mean any organisms that cause disease or an adverse health impact to humans, except that the commissioner may prescribe by regulation additional infectious agents as may be necessary to protect human health and the environment.
§ 1389-bb. Requirements for generators of regulated medical waste.
1. All the requirements of this title shall apply to hospitals as defined in subdivision one of section twenty-eight hundred one of this chapter and to residential health care facilities as defined in subdivision three of section twenty-eight hundred one of this chapter and clinical laboratories as defined in section five hundred seventy-one of this chapter.
2. The commissioner shall promulgate regulations establishing standards which shall be applicable to generators of regulated medical waste, as may be necessary to protect human health and the environment. Such standards shall include, but need not be limited to, requirements respecting:
(a) Recordkeeping practices that accurately identify the quantities of such regulated medical waste produced and the disposition thereof;
(b) Compliance with the marking, labeling and packaging requirements pursuant to section thirteen hundred eighty-nine-cc of this title;
(c) Compliance with the tracking system pursuant to section 27-1504 of the environmental conservation law; and
(d) Submission of an annual report to the commissioner of environmental conservation, and additional reports at such times as the said commissioner deems necessary, on such forms as the said commissioner shall prescribe, respecting the quantities of regulated medical waste produced during a specified time period, and the disposition thereof.
§ 1389-cc. Storage and containment of regulated medical waste.
1. Containment of regulated medical waste shall be in a manner and location which affords protection from the environment and limits exposure to the public.
2. Regulated medical waste shall be separated from other waste as soon as practicable in the generator's facility.
3. Unless otherwise approved by the department, regulated medical waste shall be contained at the producing facility only for such periods and under such conditions pursuant to rules and regulations adopted in furtherance of this title.
4. Containment of regulated medical waste shall be separate from other wastes. Containers used for the containment of regulated medical waste January 24, 2001 shall be marked prominently on the containers with the universal warning sign or the word "biohazard".
5. Regulated medical waste, except for discarded sharps, shall be contained in bags which are impervious to moisture and have a strength sufficient to resist ripping, tearing or bursting under normal conditions of usage and of handling. The bags shall be secured so as to prevent leakage during storage, handling or transport. All bags used for containment and disposal of regulated medical wastes shall be red in color.
6. All discarded sharps shall be contained for disposal in leakproof, rigid, puncture-resistant containers which are secured to preclude loss of the contents. Such containers shall be red in color or shall be conspicuously labeled with the word "infectious" or the words "regulated medical waste".
7. Before regulated medical waste is transported from the generating facility, regulated medical waste contained in disposable containers shall be placed for storage or handling in disposable or reusable pails, cartons, drums, dumpsters or portable bins. The containment system shall be leakproof, have tight-fitting covers and be kept clean and in good repair. The containers may be of any color and shall be conspicuously labeled with the word "infectious" or the words "regulated medical waste".
8. Reusable containers for regulated medical waste shall be thoroughly washed and decontaminated each time they are emptied unless the surfaces of the containers have been completely protected from contamination by disposable liners, bags or other devices removed with the waste.
9. Reusable pails, drums, dumpsters or bins used for containment of regulated medical waste shall not be used for containment of waste to be disposed of as other wastes or for other purposes except after being decontaminated.
10. Trash chutes shall not be used to transfer regulated medical waste between locations where it is contained.
§ 1389-dd. Treatment and disposal of regulated medical waste.
1. Treatment or disposal of regulated medical waste shall be by one of the following methods:
(a) By incineration in a regulated medical waste incineration facility approved and under permit pursuant to article nineteen of the environmental conservation law, which provides complete combustion of the waste to carbonized or mineralized ash. Regulated medical waste so combusted shall be disposable as nonhazardous waste provided it is not an otherwise hazardous waste as defined in the regulations promulgated under section 27-0903 of the environmental conservation law.
(b) By discharge to sewerage system if the waste is liquid or semiliquid, except as specifically prohibited by the commissioner of health.
(c) By decontamination by autoclaving, or by other technique approved by the department, so as to render the waste noninfectious. Regulated medical waste so treated shall be disposed of as solid waste provided it does not otherwise meet the definition of hazardous waste as defined in the regulations promulgated under section 27-0903 of the environmental conservation law or the regulations promulgated thereunder, and is accompanied by a certificate, in a form prescribed by the commissioner, which evidences such treatment.
(d) By other method approved by the commissioner.
2. Regulated medical waste shall not be disposed of by burial at a landfill disposal facility, unless treated in accordance with subdivision one of this section. All sharps must be rendered unrecognizable prior to disposal.
3. The commissioner, in consultation with the commissioner of environmental conservation, shall develop a limited number of cooperative pilot projects to promote the safe handling, treatment and disposal of regulated medical waste generated in private residences, including the establishment of guidelines for safe transport and handling of such waste prior to disposal. Such pilot projects shall be limited to a maximum of four municipalities throughout the state, and may vary in scope from single-facility to multi-facility projects. Nothing in this subdivision shall be construed as imposing any new requirements on generators of regulated medical waste. The commissioner shall give due consideration to the experience of the pilot projects in developing rules and regulations authorized in subdivision four of this section. Any moneys allocated by any government or organization to the department of health or the department of environmental conservation for purposes of establishing such pilot projects are hereby authorized for appropriation pursuant to this subdivision.
4. Sharps, including needles, syringes and lancets, originating from a private residence, may be delivered for disposal to a general hospital, as defined in subdivision ten of section twenty-eight hundred one of this chapter, or a residential health care facility, as defined in subdivision three of section twenty-eight hundred one of this chapter. Sharps, including needles, syringes and lancets returned pursuant to this section must be accepted by the hospital or residential health care facility on the condition that the needles, syringes and lancets have been deposited in an approved puncture proof container by the generator. The hospital or residential health care facility receiving such contained sharps must dispose of sharps in accordance with this section. The commissioner shall promulgate rules and regulations establishing guidelines for safe transport and handling of such sharps, including the approval of puncture proof containers for sharps.
§ 1389-ee. Transfer of regulated medical waste to off-site treatment and disposal facilities.
1. Any generator of regulated medical waste shall transfer custody of the waste only to a transporter who is permitted as a regulated medical waste transporter by the department of environmental conservation.
2. Regulated medical waste shall be transported to an off-site treatment or disposal facility in a leakproof, fully enclosed container or vehicle compartment.
3. Regulated medical waste shall not be transported in the same vehicle with other waste unless the regulated medical 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 or disposed of as regulated medical waste in accordance with the requirements of this title.
§ 1389-ff. Rules and regulations.
The commissioner shall promulgate rules and regulations in conformity with the standards for generators of regulated medical waste, and the storage, containment, treatment and disposal of regulated medical waste found in this title. Nothing in this title shall authorize the commissioner to adopt or amend any rule or regulation in a manner inconsistent with the provisions of title fifteen of article twenty-seven of the environmental conservation law.
§ 1389-gg. Violations of title thirteen.
1. Notwithstanding any other provision of this chapter, any person who violates any of the provisions of, or who fails to perform any duty imposed by this title or any rule or regulation promulgated pursuant thereto, or any term or condition of any certificate or permit issued pursuant thereto, or any final determination or order of the commissioner made pursuant to this title shall be liable in the case of a first violation for a civil penalty not to exceed twenty-five hundred dollars and an additional penalty of not more than one thousand dollars for each day during which such violation continues, to be assessed by the commissioner after an opportunity to be heard pursuant to the provisions of this chapter or by the court in any action or proceeding pursuant to this chapter, and, in addition thereto, such person may by similar process be enjoined from continuing such violation and any permit or certificate issued to such person may be revoked or suspended or a pending renewal application denied. In the case of a second and any further violation, the liability shall be for a civil penalty not to exceed five thousand dollars for each such violation and an additional penalty not to exceed twenty-five hundred dollars for each day during which such violation continues.
2. No penalty assessed or imposed pursuant to the provisions of this title shall be paid from medicaid or medicare funds.