I 
112TH CONGRESS 
1ST SESSION H. R. 2546 
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 
JULY 14, 2011 
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 2011’’. 
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 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 waste, 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) Waste from surgery or autopsy that 
has been in contact with infectious agents, in-
cluding soiled dressings, sponges, drapes, lavage 
tubes, drainage sets, underpads, and surgical 
gloves. 
‘‘(vii) Laboratory waste from medical, 
pathological, pharmaceutical, or other research, 
commercial, or industrial laboratories that has 
been in contact with infectious agents, including 
slides and cover slips, disposable gloves, labora-
tory coats, and aprons. 
‘‘(viii) Dialysis waste that has been in con-
tact 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 waste that is 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 disease. 
‘‘(xi) Solid waste generated during— 
‘‘(I) the diagnosis or treatment of dis-
ease in human beings or animals; 
‘‘(II) the provision of medical services 
(including immunizations) to human beings 
or animals; 
‘‘(III) post-mortem clean-up or au-
topsy preparations for human beings or 
animals; 
‘‘(IV) medical research on human 
beings or animals; 
‘‘(V) the operation of a syringe ex-
change program; or 
‘‘(VI) the production or testing of a 
biological product (as defined in section 
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351 of the Public Health Service Act (42 
U.S.C. 262)). 
‘‘(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 2011, 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: 
‘‘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: 
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‘‘(1) Tracking medical waste from any gener-
ator of such waste to any disposal facility that dis-
poses of such waste, including a recordkeeping 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. 
‘‘(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. 
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‘‘(6) Monitoring of generators and transporters 
of medical waste and storage and disposal facilities 
that store or dispose of medical waste for compliance 
with the program under this section. 
‘‘(7) A requirement that such generators, trans-
porters, and facilities provide adequate training to 
individuals who handle medical waste to ensure com-
pliance with the program under this section. 
‘‘(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 
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 
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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 storage 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. 
‘‘(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 ex-
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emption does not endanger the environment or 
human health, as determined by the Administrator. 
‘‘(d) REGULATIONS.— 
‘‘(1) IN GENERAL.—For purposes of the pro-
gram under this section, not later than the last day 
of the one-year period beginning on the date of en-
actment of the Medical Waste Management Act of 
2011, 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. 
‘‘SEC. 11002. SPECIFIC REQUIREMENTS FOR GENERATORS, 
TRANSPORTERS, AND STORAGE AND DIS-
POSAL FACILITIES. 
‘‘(a) SPECIFIC REQUIREMENTS FOR GENERATORS.— 
‘‘(1) IN
GENERAL.—A generator of medical 
waste shall— 
‘‘(A) provide any transporter that is trans-
porting medical waste from the generator to a 
disposal facility— 
‘‘(i) with a written assurance that the 
generator has complied with all labeling, 
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packaging, and storage requirements under 
section 11001 with respect to such medical 
waste; and 
‘‘(ii) with a properly completed mani-
fest form for transporting such waste 
under section 11001(b)(2); 
‘‘(B) register with the Administrator; and 
‘‘(C) provide the Administrator with the 
name of all transporters used by the generator 
to transport medical waste. 
‘‘(2) APPLICATION TO TATTOO AND BODY ART 
ESTABLISHMENTS.—A body art establishment (in-
cluding a tattoo parlor) shall be considered to be a 
generator of medical waste for purposes of this sub-
title. 
‘‘(b) 
SPECIFIC
REQUIREMENTS
FOR
TRANS-
PORTERS.—A transporter of medical waste shall— 
‘‘(1) not accept medical waste from a generator 
without receiving a written assurance, with regard to 
such waste, that is described in subsection (a)(1)(A); 
‘‘(2) register with the Administrator; and 
‘‘(3) disclose to the Administrator the number 
and type of vehicles used by the transporter to 
transport medical waste and the equipment and 
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methods used to ensure segregation and handling of 
such waste in accordance with this subtitle. 
‘‘(c) SPECIFIC REQUIREMENTS FOR STORAGE FA-
CILITIES.—An owner or operator of a storage facility 
shall— 
‘‘(1) provide notice of the storage of medical 
waste to the generator of that medical waste; and 
‘‘(2) register with the Administrator. 
‘‘(d) 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. 
‘‘(e) 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. 
‘‘(f) 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.— 
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‘‘(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 
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; 
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‘‘(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 
‘‘(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)(D), 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. 
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‘‘(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 
to records, reports, and information obtained under sec-
tion 3007. 
‘‘SEC. 11004. FEDERAL ENFORCEMENT. 
‘‘The provisions of section 3008 (except for sub-
section (d)(7) and to the extent such section applies to 
used oil) shall apply to a violation of this subtitle, with 
respect to medical waste, in the same manner and to the 
same extent as such provisions apply to a violation of sub-
title C, with respect to hazardous waste except that any 
reference in section 3008 to— 
‘‘(1) section 3006 shall be treated as a ref-
erence to section 11005; 
‘‘(2) a permit under this subtitle shall be treat-
ed as a reference to registration under section 
11002; and 
‘‘(3) authorization to operate under section 
3005(e) shall be treated as a reference to a registra-
tion under section 11002. 
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‘‘SEC. 11005. AUTHORIZED STATE MEDICAL WASTE PRO-
GRAMS. 
‘‘The provisions of section 3006 (except for sub-
sections (g) and (h) and paragraphs (3) and (4) of sub-
section (c)) shall, to the extent consistent, apply to this 
subtitle, with respect to medical waste, in the same man-
ner as such provisions apply to subtitle C, with respect 
to hazardous waste, except that any reference in section 
3006 to— 
‘‘(1) the date of enactment of this Act shall be 
treated as a reference to the date of enactment of 
the Medical Waste Management Act of 2011; 
‘‘(2) the date of promulgate of regulations 
under sections 3002, 3004, and 3005, shall be treat-
ed as a reference to the date of promulgation of reg-
ulations under section 11001, 11002, and 11003; 
and 
‘‘(3) January 31, 1986, shall be treated as a 
reference to December 31, 2011. 
‘‘SEC. 11006. SYRINGE DISPOSAL PROGRAM. 
‘‘(a) IN GENERAL.—The Administrator shall estab-
lish a program on syringe disposal to— 
‘‘(1) educate the public about acceptable meth-
ods for disposal of used syringes generated by indi-
viduals through personal use of such syringes out-
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side of medical facilities, including through house-
hold use; and 
‘‘(2) provide grants to State and local govern-
ments and nonprofit and private entities— 
‘‘(A) to educate the public about such 
methods; and 
‘‘(B) to increase access to such disposal 
methods. 
‘‘(b) ACCEPTABLE DISPOSAL METHODS.—For pur-
poses of this section, acceptable methods of disposal of 
used syringes shall be determined by the Administrator 
and may include community drop-off programs, hazardous 
waste facilities that accept household waste, mail-back 
programs, syringe exchange programs, and needle destruc-
tion devices. 
‘‘(c) UNACCEPTABLE
DISPOSAL
METHODS.—For 
purposes of this section, disposal— 
‘‘(1) in household garbage is not an acceptable 
disposal method unless the syringe has been appro-
priately (as determined by the Administrator) steri-
lized and destroyed; and 
‘‘(2) through the sewage system is not an ac-
ceptable disposal method. 
‘‘SEC. 11007. REPORTS TO CONGRESS. 
‘‘(a) ANNUAL REPORT.— 
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‘‘(1) IN GENERAL.—Not later than one year 
after the date of enactment of the Medical Waste 
Management Act of 2011 and annually thereafter, 
the Administrator shall report to Congress on the 
following: 
‘‘(A) The types, number, and size of gen-
erators of medical waste in the United States. 
‘‘(B) The types and amounts of medical 
waste generated in the United States. 
‘‘(C) The methods currently used to han-
dle, store, transport, treat, and dispose of the 
medical waste, including the extent to which 
such waste is disposed of in sewer systems. 
‘‘(D) The present and potential costs— 
‘‘(i) to local economies, persons, and 
the environment from the improper han-
dling, storage, transportation, treatment, 
or disposal of medical waste; and 
‘‘(ii) to generators, transporters, and 
storage and disposal facilities from regula-
tions establishing requirements related to 
tracking, handling, storing, transporting, 
treating, and disposing of medical waste. 
‘‘(E) Available and potentially available 
methods for handling, storing, transporting, 
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and disposing of medical waste and their advan-
tages and disadvantages. 
‘‘(F) Available and potentially available 
methods for treating medical waste, including 
methods of sterilization, chemical treatment, 
and grinding. 
‘‘(G) The advantages and disadvantages of 
such treatment methods, including the extent to 
which such methods— 
‘‘(i) render medical waste noninfec-
tious or less infectious; 
‘‘(ii) make medical waste unrecogniz-
able; and 
‘‘(iii) protect human health and the 
environment. 
‘‘(H) Factors impacting the effectiveness 
of the treatment methods identified in subpara-
graph (F), including quality control and quality 
assurance procedures, maintenance procedures, 
and operator training. 
‘‘(I) Available and potentially available 
methods for the reuse or reduction of the vol-
ume of medical waste generated. 
‘‘(b) STUDY AND REPORT ON INDIVIDUAL GENERA-
TORS.— 
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‘‘(1) STUDY.—The Administrator shall conduct 
a study on— 
‘‘(A) the type of medical waste (including 
used syringes) generated by individuals through 
personal use of medical products outside of 
medical facilities; 
‘‘(B) the volume of such waste; 
‘‘(C) the availability and cost of disposal 
and treatment of such waste; 
‘‘(D) the impact on the environment and 
human health of excluding such waste from the 
medical waste management program under sec-
tion 11001; and 
‘‘(E) the extent to which individuals are 
aware of and use available disposal and treat-
ment options for such waste. 
‘‘(2) REPORT.—Not later than the last day of 
the one-year period beginning on the date of enact-
ment of the Medical Waste Management Act of 
2011, the Administrator shall submit a report to 
Congress containing— 
‘‘(A) the results of the study under para-
graph (1); 
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‘‘(B) recommended standards for the han-
dling, storage, treatment, and disposal of such 
waste; and 
‘‘(C) recommendations for educating the 
public about such standards. 
‘‘(c) CONSULTATION.—In preparing the reports 
under this section, the Administrator shall consult with 
appropriate State and local agencies. 
‘‘SEC. 11008. GENERAL PROVISIONS. 
‘‘(a) CONSULTATION.—(1) In promulgating regula-
tions under this subtitle, the Administrator shall consult 
with the States and may consult with other interested par-
ties. 
‘‘(2) The Administrator shall also consult with the 
International Joint Commission (as established by the 
Boundary Waters Treaty of 1909 between Canada and the 
United States) to determine how to track medical waste 
entering the United States from Canada. 
‘‘(b) PAPERWORK REDUCTION ACT.—The promulga-
tion of such regulations shall not be subject to the Paper-
work Reduction Act of 1980. 
‘‘(c) RELATIONSHIP TO SUBTITLE C.—Nothing in 
this subtitle shall affect the authority of the Administrator 
to regulate medical waste under subtitle C of this Act. 
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‘‘SEC. 11009. EFFECTIVE DATE OF REGULATIONS. 
‘‘The regulations promulgated under this subtitle 
shall take effect on the last day of the 90-day period begin-
ning on the date such regulations are promulgated.’’. 
(c) TABLE OF CONTENTS.—The table of contents for 
the Solid Waste Disposal Act is amended by striking the 
items relating to subtitle J and inserting the following: 
‘‘Subtitle J—Medical Waste Management Program 
‘‘Sec. 11001. Medical waste management program. 
‘‘Sec. 11002. Specific requirements for generators, transporters, and storage 
and disposal facilities. 
‘‘Sec. 11003. Inspections. 
‘‘Sec. 11004. Federal Enforcement. 
‘‘Sec. 11005. Authorized State medical waste programs. 
‘‘Sec. 11006. Syringe Disposal Program. 
‘‘Sec. 11007. Reports to Congress. 
‘‘Sec. 11008. General provisions. 
‘‘Sec. 11009. Effective date of regulations.’’. 
Æ 
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