35 Ill. Adm. Code 1420.102
Definitions
Section 1420
Section 1420.102Â Definitions
All definitions in this Section
have the following meanings throughout this Subtitle, unless specifically stated
otherwise. Words and terms not defined have the meanings stated in the Act.
"6-log
reduction" means a 6-decade reduction or a one millionth (0.000001)
survival probability in a microbial population.
"Act"
means the Environmental Protection Act [415 ILCS 5].
"Agency"
means the Illinois Environmental Protection Agency.
"ATCC"
means American Type Culture Collection.
"Board"
means the Pollution Control Board.
"CFU"
means colony forming unit.
"Chemical
treatment" means using disinfectants or chemicals as the primary means to
eliminate the infectious potential of PIMW. Examples include treatment with
ethylene oxide, chlorine, and ozone.
"Class 4
etiologic agent" means a pathogenic agent that is extremely hazardous to
laboratory
personnel or that may cause serious epidemic disease. Class 4 etiologic agent includes
the following viral agents:
Alastrim,
Smallpox, Monkey pox, and Whitepox (when used for transmission or animal
inoculation experiments);
Hemorrhagic
fever agents (including Crimean hemorrhagic fever (Congo), Junin, and Machupo
viruses, and others not yet defined);
Herpes virus
simiae (Monkey B virus);
Lassa virus;
Marburg virus;
Tick-borne
encephalitis virus complex (including Absettarov, Hanzalova, HYPR, Kumlinge,
Russian spring-summer encephalitis, Kyasanur forest disease, Omsk hemorrhagic
fever, and Central European encephalitis viruses);
Venezuelan
equine encephalitis virus (epidemic strains, when used for transmission or
animal inoculation experiments);
Yellow fever
virus (wild, when used for transmission or animal inoculation experiments);
Guanarito
virus;
Sabia;
Ebola virus;
and
Equine
Morbillivirus.
BOARD NOTE:Â The
definition of Class 4 agent is adopted under Section 56.2(e) of the Act to help
define an "isolation waste" for Section 3.360(a)(6) of the Act and
this Subtitle. This listing is derived from the CDC document
"Classification of Etiologic Agents on the Basis of Hazard, 1974",
and is supplemented from the CDC/NIH document "Biosafety in
Microbiological and Biomedical Laboratories", December 2009, and "NIH
Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)", April 2019.
"Container"
means a receptacle that does not contain PIMW.
"Detergent"
means a cleansing substance that contains surface-active agents for rapid
wetting, penetration, and emulsification of fats and oils, plus a sequestering
agent.
"Detergent-sanitizer
cleaner" means an agent that is both a detergent and sanitizer registered
by the United States Environmental Protection Agency (USEPA), as identified on
its label.
"Discharge"
means the accidental or intentional spilling, leaking, pumping, pouring, emitting,
emptying, or dumping of waste into or on any land or water. This does not
include the normal loading and unloading of PIMW from a vehicle.
"Enclosed
compartment" means a compartment that protects from the elements, prevents
spillage and prevents containers from falling off the vehicle. The enclosed
compartment cannot be used to meet the packaging requirements of 35 Ill. Adm.
Code 1421.Subpart C.
"Equivalent
log kill"Â means the logarithm of the indicator microorganisms that must
be killed and correlates to a 6-log reduction of viable test microorganisms.
"Highly
communicable disease" means a disease identified as a Class 4 etiologic agent
under this Section.
"Indicator
microorganisms" means those microorganisms listed in 35 Ill. Adm. Code 1422.Appendix
A, Table B, as classified by ATCC.
"International
biohazard symbol" means the symbol that is shown in 35 Ill. Adm. Code
1421.Illustration A.
"Irradiation
treatment" means using ionizing radiation as the primary means to
eliminate the infectious potential of PIMW. Examples include treatment with
gamma (cobalt 60) and electron beam.
"Log"
means logarithm to the base 10.
"Log
kill"Â means the difference between the logarithms of viable test
microorganisms or indicator microorganisms before and after treatment.
"Oversized
PIMW" means a single waste item that is too large to be placed into a 33
gallon bag or container.
"Package"
means a receptacle that contains PIMW.
"Person"
is any individual, partnership, co-partnership, firm, company, corporation,
association, joint stock company, trust, estate, political subdivision, state
agency, or any other legal entity, or their representative, agent, or assigns.
(Section 3.315 of the Act)
"PFU"
means plaque forming unit.
"Potentially
infectious medical waste
" or "PIMW"
means the following
types of waste generated in connection with the diagnosis, treatment (i.e.,
provision of medical services), or immunization of human beings or animals;
research pertaining to the provision of medical services; or the production or
testing of biologicals:
Cultures
and stocks. This waste shall include but not be limited to 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.
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.
Human blood
and blood products. This waste shall include discarded human blood, blood
components (e.g., serum and plasma), or saturated material containing free
flowing blood or blood components.
Used sharps.Â
This waste shall include but not be limited to discarded 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; Pasteur pipettes; scalpel blades; or blood vials. This
waste shall also include but not be limited to other types of broken or
unbroken glass (including slides and cover slips) in contact with infectious
agents.
Animal
waste. Animal waste means discarded materials, including carcasses, body
parts, body fluids, blood, or bedding originating from animals inoculated
during research, production of biologicals, or pharmaceutical testing with
agents infectious to humans.
Isolation
waste. This waste shall include discarded materials contaminated with blood,
excretions, exudates, and secretions from humans that are isolated to protect
others from highly communicable diseases,
as defined in this Section
.
Unused
sharps. This waste shall include but not be limited to the following unused,
discarded sharps: hypodermic, intravenous, or other needles; hypodermic or
intravenous syringes; or scalpel blades.
Potentially
infectious medical waste does not include
:
Waste
generated as general household waste;
Waste
(except for sharps) for which the infectious potential has been eliminated by
treatment; or
Sharps that
meet both of the following conditions:
The
infectious potential has been eliminated from the sharps by treatment; and
The sharps
are rendered unrecognizable by treatment.
Sharps that
are managed in accordance with the following requirements:
The infectious potential is
eliminated from the sharps by treatment at a facility that is permitted by the
Agency for the treatment of PIMW;
The sharps are certified by the
treatment facility as non-special waste in accordance with Section 22.48 of the
Act;
The sharps are packaged at the
treatment facility the same as required under Board rules for PIMW;
The sharps are transported
under the custody of the treatment facility to a landfill permitted by the
Agency under Section 21 of the
Act to accept municipal waste for
disposal; and
The management of sharps is authorized
in, and conducted in accordance with, a permit issued by the Agency to the
treatment facility.
(Section 3.360 of the Act)
"Putrescence"
means the partial decomposition of organic matter by microorganisms that causes
malodors, gases, or other offensive conditions, or that can provide food for
vectors.
"Registered
professional engineer" means a person registered under the Illinois
Professional Engineering Practice Act [225 ILCS 325].
"Reusable
container" means a receptacle that complies with 35 Ill. Adm. Code
1421.121(a) and (b); is made and repaired with materials that are corrosion
resistant and non-absorbent; and designed and constructed to easily permit
cleaning and disinfection in compliance with Section 1420.107.
"Sanitizer"
means an antimicrobial agent that is intended for application to inanimate
objects or surfaces for reducing the microbial count to safe levels and that is
registered by USEPA, as identified on its label.
"Sharps"
mean unused sharps and used sharps as stated in the definition of PIMW with or
without residual fluids.
"Significant
mechanical change" means the substitution or addition of mechanical parts
that result in different operating conditions. A significant mechanical change
does not mean the replacement of a part that meets the same specifications as
the original.
"Single-use
container" means a container intended by the manufacturer for one use only
(e.g., biohazard bags).
"Site"
means any location, place, tract of land, and facilities, including but not
limited to buildings, and improvements used for purposes subject to regulation
or control by the Act or regulations thereunder.
(Section 3.460 of the
Act)Â For this Subtitle, every educational institution's campus is a single
site.
"Storage"
means the containment of waste, either on a temporary basis or for a period of
years, in such a manner as not to constitute disposal.
(Section 3.480 of
the Act)
"Storage
site"
means
a site at which waste is stored. "Storage
site" includes transfer stations.
(Section 3.485 of the Act)
"Test
microorganisms" means those microorganisms listed in 35 Ill. Adm. Code
1422.Appendix A, Table A, as classified by ATCC.
"Thermal
treatment" means using elevated temperatures as the primary means to
eliminate the infectious potential of PIMW. Examples of thermal treatment are
incineration, steam sterilization, microwaving, radiowaving, infrared heating,
pyrolysis, plasma systems, and laser treatments.
"Transfer
station" means a site or facility that accepts waste for temporary storage
or consolidation and further transfer to a waste disposal, treatment or storage
facility. "Transfer station" includes a site where waste is
transferred from
:
a rail
carrier to a motor vehicle or water carrier;
a water
carrier to a rail carrier or motor vehicle;
a motor
vehicle to a rail carrier, water carrier or motor vehicle;
a rail
carrier to a rail carrier, if the waste is removed from a rail car; or
a water
carrier to a water carrier, if the waste is removed from a vessel.
(Section
3.500 of the Act)
"Treatment"
means any method, technique or process, including neutralization, designed to
change the physical, chemical, or biological character or composition of any
waste so as to neutralize it or render it nonhazardous, safer for transport,
amenable for recovery, amenable for storage, or reduced in volume. Such term
includes any activity or processing designed to change the physical form or
chemical composition of hazardous waste so as to render it nonhazardous.
(Section 3.505 of the Act)
"Unrecognizable"
means relating to a sharp that has undergone physical alteration (e.g.,
melting, charring, corroding, or grinding) so that the sharp may no longer be
used for its intended purpose.
"Vector"
means any living agent, other than human, capable of transmitting, directly or
indirectly, an infectious disease.
"Vehicle"
means any device used to transport special waste in bulk or in packages, tanks
or other containers.