I 
110TH CONGRESS 
2D SESSION 
H. R. 7163 
To amend the Solid Waste Disposal Act to require the Administrator of 
the Environmental Protection Agency to promulgate regulations on the 
management of medical waste. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 26, 2008 
Mr. PALLONE introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Solid Waste Disposal Act to require the Ad-
ministrator of the Environmental Protection Agency to 
promulgate regulations on the management of medical 
waste. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Waste Man-
agement Act of 2008’’. 
SEC. 2. TRACKING AND DISPOSAL OF MEDICAL WASTE. 
(a) DEFINITION OF MEDICAL WASTE.—Section 1004 
of the Solid Waste Disposal Act (42 U.S.C. 6903) is 
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amended by striking paragraph (40) and inserting the fol-
lowing: 
‘‘(40)(A) Except as provided in subparagraph 
(C), the term ‘medical waste’ means any solid waste 
which is generated in the diagnosis, treatment, or 
immunization of human beings or animals, in re-
search pertaining thereto, or in the production or 
testing of biologicals. 
‘‘(B) Such term includes each of the following 
types of solid waste: 
‘‘(i) Cultures and stocks of infectious 
agents and associated biologicals, including cul-
tures from medical and pathological labora-
tories, cultures and stocks of infectious agents 
from research and industrial laboratories, 
wastes from the production of biologicals, dis-
carded live and attenuated vaccines, and culture 
dishes and devices used to transfer, inoculate, 
and mix cultures. 
‘‘(ii) Pathological wastes, including tissues, 
organs, and body parts that are removed during 
surgery or autopsy. 
‘‘(iii) Waste human blood and products of 
blood, including serum, plasma, and other blood 
components. 
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‘‘(iv) Sharps (as such term is defined by 
the Secretary) that have been used in patient 
care or in medical, research, or industrial lab-
oratories, including hypodermic needles, sy-
ringes, pasteur pipettes, broken glass, and scal-
pel blades. 
‘‘(v) Contaminated carcasses, body parts, 
and bedding of animals that have been exposed 
to infectious agents during research, production 
of biologicals, or testing of pharmaceuticals. 
‘‘(vi) Wastes from surgery or autopsy that 
have been in contact with infectious agents, in-
cluding soiled dressings, sponges, drapes, lavage 
tubes, drainage sets, underpads, and surgical 
gloves. 
‘‘(vii) Laboratory wastes from medical, 
pathological, pharmaceutical, or other research, 
commercial, or industrial laboratories that have 
been in contact with infectious agents, including 
slides and cover slips, disposable gloves, labora-
tory coats, and aprons. 
‘‘(viii) Dialysis wastes that have been in 
contact with the blood of patients undergoing 
hemodialysis, including contaminated disposable 
equipment and supplies such as tubing, filters, 
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disposable sheets, towels, gloves, aprons, and 
laboratory coats. 
‘‘(ix) Discarded medical equipment and 
parts that have been in contact with infectious 
agents. 
‘‘(x) Solid wastes that are likely to be con-
taminated with infectious agents because the 
wastes have been in contact with humans or 
animals that are quarantined to protect other 
humans or animals from communicable dis-
ease.’’ 
‘‘(C) Such term does not include any hazardous 
waste identified or listed under subtitle C or any 
household waste as defined in regulations under sub-
title C. 
‘‘(D) Not later than the last day of the two- 
year period beginning on the date of enactment of 
the Medical Waste Management Act of 2008, the 
Administrator shall promulgate regulations listing 
types of medical waste.’’. 
(b) AMENDMENT OF SOLID WASTE DISPOSAL ACT.— 
The Solid Waste Disposal Act is amended by striking sub-
title J (42 U.S.C. 6992 et seq.) and inserting the fol-
lowing: 
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‘‘Subtitle J—Medical Waste 
Management Program 
‘‘SEC. 11001. MEDICAL WASTE MANAGEMENT PROGRAM. 
‘‘(a) IN GENERAL.—The Administrator shall conduct 
a medical waste management program for the purpose of 
protecting human health and the environment from med-
ical waste. 
‘‘(b) COMPONENTS
OF PROGRAM.—The program 
under subsection (a) shall provide for the following: 
‘‘(1) Tracking medical waste from any gener-
ator of such waste to any disposal facility that dis-
poses of such waste, including a record keeping sys-
tem for generators who dispose of medical waste at 
the same facility where the waste is generated. 
‘‘(2) A uniform manifest form prepared by the 
generator of any medical waste that accompanies the 
waste as it is being transported from a generator to 
a disposal facility. 
‘‘(3) Labeling and packaging requirements 
that— 
‘‘(A) foster safe handling of the waste; 
‘‘(B) protect the public from exposure to 
infectious disease; and 
‘‘(C) provide for the identification of the 
generator of the waste. 
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‘‘(4) Storage requirements, including a require-
ment for segregation of the waste at the point of 
generation and during transportation. 
‘‘(5) Proper disposal of medical waste through 
appropriate methods of disposal that— 
‘‘(A) are approved by the Administrator; 
and 
‘‘(B) provide adequate protection for the 
environment and human health. 
‘‘(6) Monitoring of generators and transporters 
of medical waste and disposal facilities that dispose 
of medical waste for compliance with the program 
under this section. 
‘‘(7) A requirement that such generators, trans-
porters, and disposal facilities provide adequate 
training to individuals who handle medical waste to 
ensure compliance with the program under this sec-
tion. 
‘‘(8) A national plan for managing medical 
waste generated in States with a shortage of dis-
posal facilities. 
‘‘(c) EXEMPTIONS.— 
‘‘(1) PROPERLY TREATED WASTE.— 
‘‘(A) IN GENERAL.—Subject to paragraph 
(4), the Administrator may make an exemption 
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from some or all of the requirements of the pro-
gram under subsection (a) for medical waste 
treated in a method described under subpara-
graph (B). 
‘‘(B) METHODS
OF
TREATMENT.—For 
purposes of this paragraph, the Administrator 
shall promulgate regulations establishing min-
imum standards for methods of treating med-
ical waste that significantly reduce the potential 
harm of such waste to the environment and to 
human health. 
‘‘(2) STORAGE
REQUIREMENTS.—Subject to 
paragraph (4), the Administrator may make an ex-
emption to the requirement under subsection (b)(4) 
that medical waste be segregated from other waste 
upon receipt of a petition for such an exemption 
from a generator, transporter, or disposal facility. 
‘‘(3) INDIVIDUALS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B) and paragraph (4), the Adminis-
trator shall make an exemption from the pro-
gram under subsection (a) for individuals who 
generate medical waste through personal use of 
medical or non-medical products outside of a 
medical facility, so long as the Administrator 
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ensures that such exemption does not endanger 
the environment or human health. 
‘‘(B) NO EXEMPTION FOR LARGE VOLUMES 
OF WASTE.—The Administrator may not make 
an exemption under subparagraph (A) for an 
individual who generates 50 pounds or more of 
medical waste in any calendar month. 
‘‘(4) PROTECTION OF THE ENVIRONMENT AND 
HUMAN HEALTH.—The Administrator may not make 
an exemption under this subsection unless the envi-
ronment and human health can be adequately pro-
tected, as determined by the Administrator. 
‘‘(d) REGULATIONS.— 
‘‘(1) IN GENERAL.—Tor purposes of the pro-
gram under this section, not later than the last day 
of the 12-month period beginning on the date of en-
actment of the Medical Waste Management Act of 
2008, the Administrator shall promulgate regula-
tions on tracking, labeling, packaging, storing, han-
dling, monitoring, and disposing of medical waste. 
‘‘(2) VARIATION
IN
RULES.—The regulations 
under paragraph (1) may include different rules for 
different types of medical waste and for different 
types of medical waste generators. 
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transport medical waste and the equipment and 
methods used to ensure segregation and handling of 
such waste in accordance with this subtitle. 
‘‘(c) SPECIFIC REQUIREMENTS FOR DISPOSAL FA-
CILITIES.—An owner or operator of a disposal facility 
shall— 
‘‘(1) provide notice of the disposal of medical 
waste to the generator of that medical waste; and 
‘‘(2) register with the Administrator. 
‘‘(d) REGISTRATION.—The Administrator may set 
appropriate requirements for registration under this sec-
tion and may collect reasonable registration fees from gen-
erators, transporters, and disposal facilities. 
‘‘(e) AVAILABILITY OF FEES.—Subject to appropria-
tions, fees collected under this section shall remain avail-
able for use by the Administrator for purposes of the med-
ical waste management program under this subtitle. 
‘‘SEC. 11003. INSPECTIONS. 
‘‘(a) REQUIREMENTS FOR ACCESS.— 
‘‘(1) IN GENERAL.—Upon request of any offi-
cer, employee, or representative of the Environ-
mental Protection Agency duly designated by the 
Administrator, for purposes of developing or assist-
ing in the development of any regulation or report 
under this subtitle or enforcing any provision of this 
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subtitle, any person who generates, stores, treats, 
transports, disposes of, or otherwise handles medical 
waste shall furnish information relating to such 
waste (including any manifest forms required under 
section 11001), conduct monitoring or testing, and 
permit such officer, employee, or representative at 
all reasonable times to have access to, and to copy, 
all records relating to such waste. 
‘‘(2) SPECIFIC
ACTIVITIES
AUTHORIZED.—To 
carry out inspections for purposes of the program 
under section 11001, officers, employees, or rep-
resentatives described under paragraph (1) are au-
thorized to— 
‘‘(A) enter at reasonable times any build-
ing, vehicle, equipment, container, or other item 
or place where medical waste is generated, 
stored, treated, disposed of, or transported; 
‘‘(B) conduct monitoring or testing relat-
ing to such waste; 
‘‘(C) inspect any such waste and any con-
tainers, labels, and documents relating to such 
waste; and 
‘‘(D) obtain from any person— 
‘‘(i) samples of such waste; and 
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‘‘(ii) samples or copies of such con-
tainers, labels, and documents. 
‘‘(b) PROCEDURES.— 
‘‘(1) PROMPT
INSPECTIONS.—Each inspection 
under this section shall be commenced and com-
pleted with reasonable promptness. 
‘‘(2) SAMPLES.— 
‘‘(A) IN
GENERAL.—If an officer, em-
ployee, or representative described under sub-
section (a)(1) obtains any samples under sub-
section (a)(2)(C), prior to leaving the site of in-
spection the officer, employee, or representative 
shall give to the owner, operator, or agent in 
charge a receipt describing each sample ob-
tained. 
‘‘(B) ANALYSIS.—If any analysis is made 
of such samples, a copy of the results of such 
analysis shall be furnished promptly to the 
owner, operator, or agent in charge of the site 
from which such sample was taken. 
‘‘(c) AVAILABILITY TO PUBLIC.—The provisions of 
section 3007(b) of this Act shall apply to records, reports, 
and information obtained under this section in the same 
manner and to the same extent as such provisions apply 
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to records, reports, and information obtained under sec-
tion 3007. 
‘‘SEC. 11004. ENFORCEMENT. 
‘‘(a) COMPLIANCE ORDERS.— 
‘‘(1) VIOLATIONS.—Whenever, on the basis of 
any information, the Administrator determines that 
any person has violated, or is in violation of, any 
provision of this subtitle (including any regulations 
promulgated to carry out this subtitle)— 
‘‘(A) the Administrator may issue an 
order— 
‘‘(i) assessing a civil penalty for such 
violation; 
‘‘(ii) requiring compliance with the 
provision being violated immediately or 
within a specified time; or 
‘‘(iii) both; or 
‘‘(B) the Administrator may commence a 
civil action in the United States district court 
in the district in which the violation occurred 
for appropriate relief, including a temporary or 
permanent injunction. 
‘‘(2) ORDERS ASSESSING PENALTIES.— 
‘‘(A) AMOUNT.—Any penalty assessed in 
an order under this subsection shall not exceed 
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$50,000 per day of noncompliance for each vio-
lation of a requirement or prohibition in effect 
under this subtitle. 
‘‘(B) CONSIDERATIONS
FOR
ASSESSMENT 
OF PENALTY.—In assessing such a penalty, the 
Administrator shall take into account the seri-
ousness of the violation and any good faith ef-
forts by the violator to comply with applicable 
requirements. 
‘‘(3) SPECIFICITY
OF
ORDERS.—Any order 
issued pursuant to this subsection shall state with 
reasonable specificity the nature of the violation. 
‘‘(4) FINALITY OF ORDER.—Any order issued 
under this subsection shall become final unless, not 
later than 30 days after issuance of the order, the 
persons named therein request a public hearing. 
‘‘(5) PUBLIC
HEARING.—Upon request for a 
public hearing under paragraph (4), the Adminis-
trator shall promptly conduct the public hearing. 
‘‘(6) VIOLATION OF COMPLIANCE ORDERS.—In 
the case of an order under this subsection requiring 
compliance with any provision of or regulation pro-
mulgated to carry out this subtitle, if a violator fails 
to take corrective action within the time specified in 
the order, the Administrator may access a civil pen-
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