New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter I - Environmental Health › Part 70 - Regulated Medical Waste › Subpart 70-1 - Application And Definitions › Section 70-1.2 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
Whenever used in this Part, unless the context of this
						Part clearly requires otherwise, the following terms shall have the following
						meanings:
(a) Alternative regulated
					 medical waste treatment system shall mean a device, method, and/ or technology
					 approved by the Commissioner of Health pursuant to Subpart 70-5 of this Part
					 for the treatment of regulated medical waste.
(b) Autoclave shall mean a device for
					 decontaminating and/or sterilizing materials through exposure to steam under
					 pressure for periods of time prescribed in Subpart 70-3 of this Part.
(c) Biologicals shall mean any preparations
					 derived from a living organism and/or its products including, but not limited
					 to, sera, nonviable vaccines, vaccines attenuated in a manner that prevents
					 propagation, antigens, toxins and antitoxins, for use in diagnosis,
					 immunization, or treatment of human beings or animals.
(d) Certificate of treatment shall mean a
					 form prescribed by the Commissioner of Health to document treatment of
					 regulated medical waste, signed by a person authorized by an on-site or
					 off-site treatment facility to attest to such treatment.
(e) Challenge testing shall mean monitoring
					 testing or procedures periodically conducted at the installation site of a
					 treatment system to demonstrate continued operation under conditions
					 established by efficacy testing for an alternative regulated medical waste
					 treatment system, or, for an autoclave, to verify continued effective treatment
					 of regulated medical waste.
(f)
					 Clinical laboratory shall have the same meaning as in section 571  of the Public Health Law.
(g) Cultures and stocks shall mean materials
					 and/or systems supporting in vitro growth or maintenance of infectious agents,
					 including, but not limited to, the infectious agents themselves, nutrient
					 agars, gels, broths, human and primate cell lines, impure animal cell lines,
					 live vaccines, and attenuated vaccines capable of propagation.
(h) Culture and dishes and devices for
					 transferring, inoculating and mixing cultures shall mean any plates, flasks,
					 tubes, beakers, vials, bottles, jars or inoculation loops of any material;
					 manual or mechanical stirring or mixing devices; stoppers or plugs of any
					 material; filtering devices of natural and artificial substances; and any other
					 items or devices for growing and/or maintaining infectious agents in
					 vitro.
(i) Cycle shall mean total
					 operating time required for a device to treat regulated medical waste, and, for
					 an autoclave, shall include warm-up, residence and cool down time.
(j) Decontamination shall mean reduction or
					 inactivation of potentially infectious agents' bioload in waste, so that such
					 waste, including any waste residual in or on a container, no longer constitutes
					 a threat to public health and safety.
(k) Destroyed shall mean torn apart or
					 mutilated through incineration, melting, shredding, grinding, tearing, breaking
					 or other process; to render unusable and unrecognizable as the item that
					 underwent destruction. Destroyed shall not mean compacted or compacted
					 following treatment. As used in this Part pertaining to sharps, unrecognizable
					 shall mean that 100 percent of the sharps must be rendered not identifiable as
					 intact sharps devices.
(l) Efficacy
					 testing shall mean testing of an autoclave or alternative regulated medical
					 waste treatment system, conducted by a laboratory independent of the system
					 manufacturer that is generally recognized within the scientific community as
					 having the capability for conducting, in conformance with generally recognized
					 scientific principles, microbiologic examinations and/or other pertinent
					 assessments of waste material to establish operating parameters for the
					 system's effective treatment of regulated medical waste.
(m) Hazardous waste shall have the same
					 meaning as in 6 NYCRR, section 360- 1.2.
(n) Toxic drug waste shall mean waste
					 contaminated by or mixed with a chemotherapeutic, cytotoxic and/or
					 antineoplastic agent, and/or a biotechnological material (e.g., infectious
					 nanoparticles), not otherwise regulated as hazardous waste under 6 NYCRR Part
					 371.
(o) Household medical waste
					 shall have the same meaning as in 6 NYCRR, section 360-1.2 and shall include
					 residential sharps (i.e., lancets, hypodermic needles and syringes) generated
					 in a household in the course of medical self-management.
(p) Incinerator shall mean an enclosed device
					 using controlled flame combustion to effect thermal breakdown of solid waste,
					 including refuse-derived fuel, to ash residue containing little or no
					 combustible material, as defined in 6 NYCRR, section 200.1 and regulated under
					 6 NYCRR, Parts 200, 201, 211, 212, 219 and 257.
(q) Infectious agent shall mean any organism
					 or agent that causes disease or an adverse health impact in humans, and shall
					 include any agent listed in Part 2 of this Title and any agent designated as
					 requiring Biosafety Level 2, 3 or 4 processing in the U.S. Department of Health
					 and Human Services, Public Health Service, Centers for Disease Control and
					 Prevention, National Institutes of Health publication, "Biosafety in
					 Microbiological and Biomedical Laboratories," 4th ed., May, 1999 and any
					 biological agents listed in  42 CFR Part 73  (Vol. 70, March 18, 2005):
					 Possession, Use and Transfer of Select Agents and Toxins. Federal regulations
					 are published by the Office of the Federal Register, National Archives and
					 Records Administration and may be purchased from the Superintendent of
					 Documents, Government Printing Office, Washington, DC 20402. Copies are
					 available for inspection and copying in the New York State Department of
					 Health, Bureau of Hospital and Primary Care Services, Hedley Park Place, 433
					 River Street, Troy, NY 12180.
(r)
					 Leakproof shall mean designed and maintained to prevent the escape of contained
					 liquids or other materials from sides or bottom, when appropriately closed
					 regardless of container orientation (i.e., upright, tipped over).
(s) Monitoring shall mean periodic assessment
					 and quality control of the operation of a regulated medical waste treatment
					 system.
(t) Operating parameters
					 shall mean the specific conditions of pressure, temperature, residence time,
					 chemical concentration, and other physical or engineering condition established
					 through efficacy testing of an alternative regulated medical waste treatment
					 system, or verified through validation testing of an autoclave for effective
					 treatment of regulated medical waste.
(u) Operation plan shall mean documented
					 policies and procedures for a facility's operation of an on-site autoclave,
					 incinerator or alternative regulated medical waste treatment system.
(v) Parametric control shall mean an
					 electronic or other device designed to monitor accurately the performance of a
					 regulated medical waste treatment system and/or regulate continuously the
					 system's operation to achieve and maintain pre-set operating
					 parameters.
(w) Patient care area
					 shall mean a room or location at which a hospital, nursing home or clinical
					 laboratory engages in medical services and/or specimen collection that results
					 in the generation of regulated medical waste. For purposes of this Part, a
					 patient service center (i.e., collection station) and a health fair operated by
					 a clinical laboratory are patient care areas.
(x) Primary container shall mean the
					 containment system in direct contact with, holding and securing regulated
					 medical waste, i.e., a red bag or sharps container.
(y) Radiological medical waste shall mean
					 regulated medical waste contaminated by or mixed with radioisotopes that are
					 emitting ionizing radiation at a level distinguishable from natural background
					 level.
(z) Regulated medical waste
					 shall mean waste generated in diagnosis, treatment or immunization of humans or
					 animals in research pertaining thereto, or in production and testing of
					 biologicals; provided, however, that regulated medical waste shall not include
					 hazardous waste and household medical waste except as prescribed in paragraph
					 (4) of this subdivision, and hazardous waste. Regulated medical waste shall
					 include:
(1) cultures and stocks; culture
					 dishes and devices used to transfer, inoculate and mix cultures that have come
					 into contact with cultures and stocks; and biologicals;
(2) human pathological waste, including:
					 tissue; organs; body parts, excluding teeth and contiguous structures of bone
					 and gum; body fluids removed during surgery, autopsy or other medical
					 procedures; specimens of body fluids and their containers; and discarded
					 materials saturated with body fluids other than urine. Human pathological waste
					 shall not include urine or fecal material submitted for purposes other than
					 diagnosis of infectious diseases;
(3) human blood and blood products, including
					 their components (e.g., serum and plasma); containers with free-flowing blood;
					 discarded blood products as defined in Subpart 58-2 of this Title; and
					 materials saturated with flowing blood (except feminine hygiene
					 products);
(4) sharps whether used
					 or unused including residential sharps accepted by a facility regulated under
					 article 28 of the Public Health Law pursuant to section 1389-dd (4)  of the
					 Public Health Law;
(5) animal
					 waste, including animal carcasses, body parts, body fluid, blood, and bedding
					 originating from animals known to be contaminated with infectious agents (i.e.,
					 zoonotic organisms) or from animals inoculated with infectious agents for
					 purposes including, but not limited to, research, production of biologicals, or
					 drug testing; and
(6) any other
					 waste materials containing infectious agents designated by the Commissioner of
					 Health as regulated medical waste.