Title: Section 70-1.2 - Definitions

70-1.2 Definitions. 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 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 fluids, 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.

(aa) "Residence time" shall mean the time necessary for effective treatment of regulated medical waste at a specific temperature, pressure and/or chemical concentration, the duration of which:

(1) for an autoclave, begins when the autoclave’s coldest area, as determined by the manufacturer, attains the temperature and pressure established by validation testing as effective for treatment of regulated medical waste, and continues for at least the minimum time established by validation testing as effective for treatment of such waste;

(2) for an incinerator, begins when the incinerator attains operating temperature in both the ignition and combustion (secondary) chambers, and continues for the time necessary to achieve a complete burn down as determined by inspection through a view port of the waste bed; and

(3) for an alternative regulated medical waste treatment system, begins when the temperature, chemical concentration or other condition established through efficacy testing has been attained, and continues for the time established through such testing, as required for effective treatment of regulated medical waste.

(ab) "Secondary container" shall mean the containment system used to hold and secure a primary container. A secondary container (e.g., outer container) shall be a disposable or reusable rigid pail, carton, drum or portable bin that is, under normal conditions of use, leak-resistant; has leak-proof sides and bottom; has a tight-fitting cover or is otherwise closeable; and is in good repair.

(ac) "Sharp" shall mean an

item capable of causing percutaneous injury, including, but not limited to, hypodermic, intravenous or other medical needles; hypodermic or intravenous syringes to which a needle or other sharp is attached; Pasteur pipettes; scalpel blades; blood vials; and broken and unbroken glass and plastic ware, including microscope slides and cover slips, in contact with

infectious agents. Sharps shall not include those parts of syringes specifically designed to allow easy removal of a hypodermic, intravenous or other medical needle, and are intended for recycling or other disposal, provided the needle has been removed and such syringe has not been in contact with infectious agents.

(ad) "Solid waste" shall have the same meaning as in 6 NYCRR, section 360-1.2.

(ae) "Sterilize" shall mean to inactivate all microbial forms of life.

(af) "Storage" shall mean temporary containment of regulated medical waste in such a manner as not to constitute disposal of such waste. “Storage area” shall mean a room, delineated area or designated space designed for storage of regulated medical waste in accordance with this Part, within a building, or on any permanent structure attached or unattached to a building, including a loading dock, situated on property owned by or under management of the facility operator. “Storage area” shall not include a trailer, bulk container or other transportable container or vehicle not owned by the facility but situated on facility property.

(ag) "Transport" shall mean shipment or conveyance of regulated medical waste from the point of generation to any intermediate point, including a treatment facility, and finally to the point of ultimate disposal.

(ah) "Treatment" shall mean any method, technology or process designed to change the character or composition of any regulated medical waste so that it no longer constitutes a threat to public health and safety. Treatment shall not include compaction.

(ai) "Universal warning sign" shall mean a symbol design that conforms to the design

shown by illustration at 29 CFR Section 1910.1030(g)(1(i)(A) (Vol. 6, July 1, 2003). 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.

(aj) "Validation testing" shall mean procedures conducted at the installation site of an alternative regulated medical waste treatment system, an incinerator, or an autoclave prior to initial operation for waste treatment, the purpose of which is to demonstrate, under pre- established operating parameters, the effective treatment of regulated medical waste at the installation site.