Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 480.000 - Minimum Requirements For The Management Of Medical Or Biological Waste (state Sanitary Code Chapter Viii) › Section 480.010 - Definitions

Current through Register 1525, July 5, 2024
Affiliated Generator
. An associated,
				professional entity including a business partner, colleague or subsidiary that
				generates medical or biological waste.
Approved Incineration Facility
. A
				facility approved and classified by the Massachusetts Department of
				Environmental Protection for incineration of waste or an out-of-state
				incinerator approved for incineration of waste by the appropriate regulatory
				agency.
Board of Health
. The appropriate and
				legally designated health authority of the city, town, or other legally
				constituted governmental unit within the Commonwealth having the usual powers
				and duties of the board of health of a city or town its authorized agent or
				representative.
BSL 1, 2, 3 and 4
. Biosafety levels
				comprised of combinations of laboratory practices and techniques, safety
				equipment, and laboratory facilities specifically appropriate for the
				operations performed, the documented or suspected routes and ease of
				transmission of the infectious agents used, the severity of the disease, and
				the laboratory function or activity conducted according to the U.S. Department
				of Health and Human Services publications,
Biosafety in Microbiological
				and Biomedical Laboratories
, an d t h e
NIH Guidelines for
				Research Involving Recombinant DNA Molecules
.
Challenge Testing
. Quality control
				testing conducted during standard operating conditions, using a pre-determined
				biological indicator, to verify the effectiveness of approved disinfection
				methods for the treatment of medical or biological waste.
Department
. Massachusetts Department
				of Public Health
Disinfection
. The reduction in level
				of microbial contamination.
Generator
.
See
Waste
				Generator
Home Sharps (HS)
. All spent
				non-commercially generated, hypodermic needles and lancets that have been used
				or are not in their original, intact and sealed packaging and that result from
				personal use or from pets at a residence or outside the home. The term Home
				Sharps does not include needles or lancets generated by home health aides,
				visiting nurses, or any other person providing a professional service in a
				private residence.
Incinerate/Incineration
. The
				controlled flame combustion of materials in an enclosed system to thermally
				break down and render the waste noninfectious.
Interment
. Burial in a
				cemetery.
IStAATT
. The International Society on
				Analytical Analysis of Treatment Technologies (formerly the State and
				Territorial Association on Alternative Treatment Technologies - STAATT), or its
				successor, comprised of a group of state and international regulators, as well
				as other experts, which reviews and publishes guidance documents related to
				medical waste treatment technologies.
Kiosk
. A secured, leak-proof
				receptacle or collection drop box, the contents of which are inaccessible to
				unauthorized personnel, designed to temporarily store approved sharps
				containers prior to pickup and transportation for treatment in accordance with
				105 CMR 480.000.
Medical and Biological Waste Alternative Treatment
				Review Group (MBWAT)
. An advisory group, established by the
				Department, which is comprised of Department and Local Board of Health staff
				and, at the discretion of the Department, industry experts, that meets at a
				minimum annually to review alternative methods of treatment, storage or
				disposal of medical and biological waste and related issues.
Medical
or
Biological
				Waste
. Waste that because of its characteristics may cause, or
				significantly contribute to, an increase in mortality or an increase in serious
				irreversible or incapacitating reversible illness; or pose a substantial
				present potential hazard to human health or the environment when improperly
				treated, stored, transported, disposed of, or otherwise managed.
The following types of waste are identified and defined as
				medical or biological waste, and shall be subject to the requirements of
				105 CMR 480.000:
(1)
Blood and Blood Products
. Discarded
				bulk human blood and blood products in free draining, liquid state; body fluids
				contaminated with visible blood; and materials saturated/dripping with blood.
				Blood Products shall not include; feminine hygiene products.
(2)
Pathological Waste
. Human
				anatomical parts, organs, tissues and body fluids removed and discarded during
				surgery, autopsy, or other medical or diagnostic procedures; specimens of body
				fluids and their containers; and discarded material saturated with body fluids
				other than urine. Pathological waste shall not include: Teeth and contiguous
				structures of bone without visible tissue, nasal secretions, sweat, sputum,
				vomit, urine, or fecal materials that do not contain visible blood or involve
				confirmed diagnosis of infectious disease.
(3)
Cultures and Stocks of Infectious Agents and
				Associated Biologicals
. All discarded cultures and stocks of
				infectious agents and associated biologicals, including culture dishes and
				devices used to transfer, inoculate, and mix cultures, as well as discarded
				live and attenuated vaccines intended for human use, that are generated
				in:
(a) Laboratories involved in basic and applied research;
(b) Laboratories intended for educational instruction;
				or
(c) Clinical laboratories
(4)
Contaminated Animal Waste
.
				Contaminated carcasses, body parts, body fluids, blood or bedding from animals
				known to be:
(a) Infected with agents of the following specific zoonotic
				diseases that are reportable to the Massachusetts Department of Agricultural
				Resources, Bureau of Animal Health pursuant to
				105
				CMR 300.140: African swine fever, Anthrax,
				Avian influenza - H5 and H7 strains and any highly pathogenic strain, Bovine
				spongiform encephalopathy (BSE), Brucellulosis, Chronic wasting disease of
				cervids, Foot and mouth disease, Glanders, Exotic Newcastle disease, Plague
				(
Y ersinia pestis
), Q Fever (
Coxiella
				burnetti
), Scrapie, Tuberculosis, Tularemia (
Francisella
				tularensis
); or
(b) Infected with diseases designated by the State
				Epidemiologist and the State Public Health Veterinarian as presenting a risk to
				human health; or
(c) Inoculated with infectious agents for purposes including,
				but not limited to, the production of biologicals or pharmaceutical
				testing.
(5)
Sharps
. Discarded medical articles
				that may cause puncture or cuts, including, but not limited to, all needles,
				syringes, lancets, pen needles, pasteur pipettes, broken medical
				glassware/plasticware, scalpel blades, suture needles, dental wires, and
				disposable razors used in connection with a medical procedure.
(6)
Biotechnology By-product
				Effluents
. Any discarded preparations, liquids, cultures,
				contaminated solutions made from microorganisms and their products including
				genetically altered living microorganisms and their products.
Medical Waste Tracking Form
. A paper
				or electronic form approved by the Department that provides confirmation to a
				generator of receipt of medical or biological waste by an off-site treatment
				facility.
Parametric Monitoring
. Automated
				equipment that records critical parameters appropriate for the treatment
				process of rendering medical or biological waste non-infectious including but
				not limited to time, temperature, pressure and pH.
RG 1, 2, 3, and 4 Agents
. Risk group
				levels resulting from the classification of the biohazardous agents based on
				their association with human disease, and the resulting severity of the
				disease, according to the U.S. Department of Health and Human Services
				publications,
Biosafety in Microbiological and Biomedical
				Laboratories
, and the
NIH Guidelines for Research Involving
				Recombinant DNA Molecules
.
Record-keeping Log
. A log book with
				secured, consecutively numbered pages which is used solely for the purpose of
				keeping and recording the information required by
				105 CMR
				480.500(B).
Sharps Collection Center (SCC)
. An
				identified site within a community that is established for the sole purpose of
				collecting home sharps pursuant to M.G.L. c. 94C, § 27A.
Shipping Papers
. A form(s) which
				accompanies material shipped off-site and contains relevant information, as
				specified in
				105 CMR 480.000 and Federal
				hazardous material transportation laws and regulations, regarding the material
				shipped.
Small-scale Generator (SSG)
. A waste
				generator, excluding home sharps users, that generates less than 50 pounds of
				medical or biological waste every 30 days.
Treatment Facility
. The off-site
				facility where medical or biological waste is rendered non-infectious prior to
				disposal as solid waste, in accordance with Massachusetts Department of
				Environmental Protection regulations or in the case of out-of-state disposal,
				in accordance with the appropriate regulatory agency responsible for solid
				waste disposal within that jurisdiction.
Unprocessed Liquid Pathological Waste
.
				Whole body fluids, not derived mechanically or chemically, which are removed
				and discarded during surgery, autopsy, or other medical or diagnostic
				procedures.
Waste Generator (Generator)
. Any
				person, corporation, partnership, trust, association, society, organized group
				of persons, body politic and corporate, public agency, authority, department,
				office and political subdivision of the Commonwealth, that generates medical or
				biological waste except home sharps and other waste generated by residents at
				private dwellings. The term "waste generator" shall include but not be limited
				to hospitals, long-term care facilities, laboratories, clinics, physician's and
				dentist's offices, schools, veterinarians, funeral homes, body piercing and
				body art facilities, trauma scene responders and home health agencies providing
				services in private dwellings.