N.Y. Comp. Codes R. & Regs. Tit. 10 § 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 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.
(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)(l)(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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.