TITLE 35: ENVIRONMENTAL PROTECTION
SUBTITLE M: BIOLOGICAL MATERIALS
CHAPTER I: POLLUTION CONTROL BOARD
SUBCHAPTER b: POTENTIALLY INFECTIOUS MEDICAL WASTES
PART 1420 GENERAL PROVISIONS
SECTION 1420.102 DEFINITIONS
Section 1420.102 Definitions
All definitions set forth in this Section have the following meanings throughout this Subtitle, unless specifically provided otherwise. Words and terms not defined have the meanings set forth 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 (Ill. Rev. Stat. 1991, ch. 111˝, par. 1001 et seq., as amended by P.A. 87-1097, effective January 1, 1993) [415 ILCS 5/1 et seq.].
"Agency" means the Illinois Environmental Protection Agency.
"ATCC" means American Type Culture Collection.
"Board" means the Illinois Pollution Control Board.
"CFU" means colony forming unit.
"Chemical treatment" means the treatment of PIMW in a unit that uses disinfectants or chemicals as the primary means to eliminate the infectious potential of the waste. Examples of chemical treatment are 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);
Herpesvirus simiae (Monkey B 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).
BOARD NOTE: A Class 4 Agent helps define an "isolation waste" for the purposes of Section 3.84(a)(6) of the Act and this Subtitle. This listing derives from the CDC document, "Classification of Etiologic Agents on the Basis of Hazard," and is supplemented from the CDC/NIH document "Biosafety in Microbiological and Biomedical Laboratories."
"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. The sanitizer must be registered by the United States Environmental Protection Agency, 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 provides protection 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" (T) means the logarithm of the indicator microorganisms that must be killed and correlates, at a minimum, to a 6-log reduction of viable test microorganisms.
"Highly Communicable Disease" means those diseases identified as Class 4 etiologic agents under this Part. (Section 3.84(a)(6) of the Act)
"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 the treatment of PIMW in a unit that uses ionizing radiation as the primary means to eliminate the infectious potential of the waste. Examples of irradiation treatment are gamma (cobalt 60) and electron beam.
"Log" means logarithm to the base ten (10).
"Log kill" (L) 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 thirty-three (33) gallon bag or container.
"Package" means a receptacle that contains PIMW.
"PFU" means plaque forming unit.
"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 3.26 of the Act)
"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 provision 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. 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. "Highly communicable diseases" means those diseases identified by the Board in rules adopted under subsection (e) of Section 56.2 of the Act. (See Section 1420.102 of this Part.)
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. (Section 3.84 of the Act)
"Putrescence" means the partial decomposition of organic matter by microorganisms so as to cause malodors, gases or other offensive conditions, or that is capable of providing food for vectors.
"Registered professional engineer" means a person registered under the Illinois Professional Engineering Practice Act (Ill. Rev. Stat. 1991, ch. 111, par. 5201 et seq.) [225 ILCS 325/1 et seq.].
"Reusable container" means a receptacle that meets the requirements of 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 so as to easily permit cleaning and disinfection in accordance with Section 1420.107 of this Subtitle. A reusable container is not a single-use container or is not made of cardboard.
"Sanitizer" means an antimicrobial agent that is intended for application to inanimate objects or surfaces for the purpose of reducing the microbial count to safe levels. The sanitizer must be registered by the United States Environmental Protection Agency, as identified on its label.
"Sharps" mean unused sharps and used sharps as stated in the definition of potentially infectious medical waste in this Section 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(s) that meets the same specifications as the original part.
"Single-use container" means a container intended by the manufacturer for one use only, such as 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 3.43 of the Act) For the purpose of this Subtitle, each campus of an educational institution is considered to be 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 3.46 of the Act)
"Storage site" means a site at which waste is stored. "Storage site" includes transfer stations. (Section 3.47 of the Act)
"Test microorganisms" means those microorganisms listed in Section 1422.Appendix A, Table A, as classified by ATCC.
"Thermal treatment" means the treatment of PIMW in a unit that uses elevated temperatures as the primary means to eliminate the infectious potential of the waste. 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 (1) a rail carrier to a motor vehicle or water carrier; (2) a water carrier to a rail carrier or motor vehicle; (3) a motor vehicle to a rail carrier, water carrier or motor vehicle; (4) a rail carrier to a rail carrier, if the waste is removed from a rail car; or (5) a water carrier to a water carrier, if the waste is removed from a vessel. (Section 3.83 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 3.49 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.
(Source: Amended at 17 Ill. Reg. 9947, effective June 21, 1993)