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 Administrator of the Environmental Protection Agency to 

promulgate regulations on the management of medical 

waste. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Waste Man5 agement Act of 2011’’. 

6 SEC. 2. TRACKING AND DISPOSAL OF MEDICAL WASTE. 

7 (a) DEFINITION OF MEDICAL WASTE.—Section 1004 

8 of the Solid Waste Disposal Act (42 U.S.C. 6903) is 

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1 amended by striking paragraph (40) and inserting the fol2 lowing: 

3 ‘‘(40)(A) Except as provided in subparagraph 

4 (C), the term ‘medical waste’ means any solid waste 

5 which is generated in the diagnosis, treatment, or 

6 immunization of human beings or animals, in re7 search pertaining thereto, or in the production or 

8 testing of biologicals. 

9 ‘‘(B) Such term includes the following types of 

10 solid waste: 

11 ‘‘(i) Cultures and stocks of infectious 

12 agents and associated biologicals, including cul13 tures from medical and pathological labora14 tories, cultures and stocks of infectious agents 

15 from research and industrial laboratories, 

16 wastes from the production of biologicals, dis17 carded live and attenuated vaccines, and culture 

18 dishes and devices used to transfer, inoculate, 

19 and mix cultures. 

20 ‘‘(ii) Pathological waste, including tissues, 

21 organs, and body parts that are removed during 

22 surgery or autopsy. 

23 ‘‘(iii) Waste human blood and products of 

24 blood, including serum, plasma, and other blood 

25 components. 

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1 ‘‘(iv) Sharps (as such term is defined by 

2 the Secretary) that have been used in patient 

3 care or in medical, research, or industrial lab4 oratories, including hypodermic needles, sy5 ringes, pasteur pipettes, broken glass, and scal6 pel blades. 

7 ‘‘(v) Contaminated carcasses, body parts, 

8 and bedding of animals that have been exposed 

9 to infectious agents during research, production 

10 of biologicals, or testing of pharmaceuticals. 

11 ‘‘(vi) Waste from surgery or autopsy that 

12 has been in contact with infectious agents, in13 cluding soiled dressings, sponges, drapes, lavage 

14 tubes, drainage sets, underpads, and surgical 

15 gloves. 

16 ‘‘(vii) Laboratory waste from medical, 

17 pathological, pharmaceutical, or other research, 

18 commercial, or industrial laboratories that has 

19 been in contact with infectious agents, including 

20 slides and cover slips, disposable gloves, labora21 tory coats, and aprons. 

22 ‘‘(viii) Dialysis waste that has been in con23 tact with the blood of patients undergoing 

24 hemodialysis, including contaminated disposable 

25 equipment and supplies such as tubing, filters, 

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1 disposable sheets, towels, gloves, aprons, and 

2 laboratory coats. 

3 ‘‘(ix) Discarded medical equipment and 

4 parts that have been in contact with infectious 

5 agents. 

6 ‘‘(x) Solid waste that is likely to be con7 taminated with infectious agents because the 

8 wastes have been in contact with humans or 

9 animals that are quarantined to protect other 

10 humans or animals from communicable disease. 

11 ‘‘(xi) Solid waste generated during— 

12 ‘‘(I) the diagnosis or treatment of dis13 ease in human beings or animals; 

14 ‘‘(II) the provision of medical services 

15 (including immunizations) to human beings 

16 or animals; 

17 ‘‘(III) post-mortem clean-up or au18 topsy preparations for human beings or 

19 animals; 

20 ‘‘(IV) medical research on human 

21 beings or animals; 

22 ‘‘(V) the operation of a syringe ex23 change program; or 

24 ‘‘(VI) the production or testing of a 

25 biological product (as defined in section 

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1 351 of the Public Health Service Act (42 

2 U.S.C. 262)). 

3 ‘‘(C) Such term does not include any hazardous 

4 waste identified or listed under subtitle C or any 

5 household waste as defined in regulations under sub6 title C. 

7 ‘‘(D) Not later than the last day of the two8 year period beginning on the date of enactment of 

9 the Medical Waste Management Act of 2011, the 

10 Administrator shall promulgate regulations listing 

11 types of medical waste.’’. 

12 (b) AMENDMENT OF SOLID WASTE DISPOSAL ACT.— 

13 The Solid Waste Disposal Act is amended by striking sub14 title J (42 U.S.C. 6992 et seq.) and inserting the fol15 lowing: 

16 ‘‘Subtitle J—Medical Waste 

17 Management Program 

18 ‘‘SEC. 11001. MEDICAL WASTE MANAGEMENT PROGRAM. 

19 ‘‘(a) IN GENERAL.—The Administrator shall conduct 

20 a medical waste management program for the purpose of 

21 protecting human health and the environment from med22 ical waste. 

23 ‘‘(b) COMPONENTS OF PROGRAM.—The program 

24 under subsection (a) shall provide for the following: 

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1 ‘‘(1) Tracking medical waste from any gener2 ator of such waste to any disposal facility that dis3 poses of such waste, including a recordkeeping sys4 tem for generators who dispose of medical waste at 

5 the same facility where the waste is generated. 

6 ‘‘(2) A uniform manifest form prepared by the 

7 generator of any medical waste that accompanies the 

8 waste as it is being transported from a generator to 

9 a disposal facility. 

10 ‘‘(3) Labeling and packaging requirements 

11 that— 

12 ‘‘(A) foster safe handling of the waste; 

13 ‘‘(B) protect the public from exposure to 

14 infectious disease; and 

15 ‘‘(C) provide for the identification of the 

16 generator of the waste. 

17 ‘‘(4) Storage requirements, including a require18 ment for segregation of the waste at the point of 

19 generation and during transportation. 

20 ‘‘(5) Proper disposal of medical waste through 

21 appropriate methods of disposal that— 

22 ‘‘(A) are approved by the Administrator; 

23 and 

24 ‘‘(B) provide adequate protection for the 

25 environment and human health. 

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1 ‘‘(6) Monitoring of generators and transporters 

2 of medical waste and storage and disposal facilities 

3 that store or dispose of medical waste for compliance 

4 with the program under this section. 

5 ‘‘(7) A requirement that such generators, trans6 porters, and facilities provide adequate training to 

7 individuals who handle medical waste to ensure com8 pliance with the program under this section. 

9 ‘‘(8) A national plan for managing medical 

10 waste generated in States with a shortage of dis11 posal facilities. 

12 ‘‘(c) EXEMPTIONS.— 

13 ‘‘(1) PROPERLY TREATED WASTE.— 

14 ‘‘(A) IN GENERAL.—Subject to paragraph 

15 (4), the Administrator may make an exemption 

16 from some or all of the requirements of the pro17 gram under subsection (a) for medical waste 

18 treated in a method described under subpara19 graph (B). 

20 ‘‘(B) METHODS OF TREATMENT.—For 

21 purposes of this paragraph, the Administrator 

22 shall promulgate regulations establishing min23 imum standards for methods of treating med24 ical waste that significantly reduce the potential 

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1 harm of such waste to the environment and to 

2 human health. 

3 ‘‘(2) STORAGE REQUIREMENTS.—Subject to 

4 paragraph (4), the Administrator may make an ex5 emption to the requirement under subsection (b)(4) 

6 that medical waste be segregated from other waste 

7 upon receipt of a petition for such an exemption 

8 from a generator, transporter, or storage or disposal 

9 facility. 

10 ‘‘(3) INDIVIDUALS.— 

11 ‘‘(A) IN GENERAL.—Subject to subpara12 graph (B) and paragraph (4), the Adminis13 trator shall make an exemption from the pro14 gram under subsection (a) for individuals who 

15 generate medical waste through personal use of 

16 medical or non-medical products outside of a 

17 medical facility. 

18 ‘‘(B) NO EXEMPTION FOR LARGE VOLUMES

19 OF WASTE.—The Administrator may not make 

20 an exemption under subparagraph (A) for an 

21 individual who generates 50 pounds or more of 

22 medical waste in any calendar month. 

23 ‘‘(4) PROTECTION OF THE ENVIRONMENT AND

24 HUMAN HEALTH.—The Administrator may not make 

25 an exemption under this subsection unless the exmstockstill on DSK4VPTVN1PROD with BILLS

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1 emption does not endanger the environment or 

2 human health, as determined by the Administrator. 

3 ‘‘(d) REGULATIONS.— 

4 ‘‘(1) IN GENERAL.—For purposes of the pro5 gram under this section, not later than the last day 

6 of the one-year period beginning on the date of en7 actment of the Medical Waste Management Act of 

8 2011, the Administrator shall promulgate regula9 tions on tracking, labeling, packaging, storing, han10 dling, monitoring, and disposing of medical waste. 

11 ‘‘(2) VARIATION IN RULES.—The regulations 

12 under paragraph (1) may include different rules for 

13 different types of medical waste and for different 

14 types of medical waste generators. 

15 ‘‘SEC. 11002. SPECIFIC REQUIREMENTS FOR GENERATORS, 

16 TRANSPORTERS, AND STORAGE AND DIS17 POSAL FACILITIES. 

18 ‘‘(a) SPECIFIC REQUIREMENTS FOR GENERATORS.— 

19 ‘‘(1) IN GENERAL.—A generator of medical 

20 waste shall— 

21 ‘‘(A) provide any transporter that is trans22 porting medical waste from the generator to a 

23 disposal facility— 

24 ‘‘(i) with a written assurance that the 

25 generator has complied with all labeling, 

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1 packaging, and storage requirements under 

2 section 11001 with respect to such medical 

3 waste; and 

4 ‘‘(ii) with a properly completed mani5 fest form for transporting such waste 

6 under section 11001(b)(2); 

7 ‘‘(B) register with the Administrator; and 

8 ‘‘(C) provide the Administrator with the 

9 name of all transporters used by the generator 

10 to transport medical waste. 

11 ‘‘(2) APPLICATION TO TATTOO AND BODY ART

12 ESTABLISHMENTS.—A body art establishment (in13 cluding a tattoo parlor) shall be considered to be a 

14 generator of medical waste for purposes of this sub15 title. 

16 ‘‘(b) SPECIFIC REQUIREMENTS FOR TRANS17 PORTERS.—A transporter of medical waste shall— 

18 ‘‘(1) not accept medical waste from a generator 

19 without receiving a written assurance, with regard to 

20 such waste, that is described in subsection (a)(1)(A); 

21 ‘‘(2) register with the Administrator; and 

22 ‘‘(3) disclose to the Administrator the number 

23 and type of vehicles used by the transporter to 

24 transport medical waste and the equipment and 

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1 methods used to ensure segregation and handling of 

2 such waste in accordance with this subtitle. 

3 ‘‘(c) SPECIFIC REQUIREMENTS FOR STORAGE FA4 CILITIES.—An owner or operator of a storage facility 

5 shall— 

6 ‘‘(1) provide notice of the storage of medical 

7 waste to the generator of that medical waste; and 

8 ‘‘(2) register with the Administrator. 

9 ‘‘(d) SPECIFIC REQUIREMENTS FOR DISPOSAL FA10 CILITIES.—An owner or operator of a disposal facility 

11 shall— 

12 ‘‘(1) provide notice of the disposal of medical 

13 waste to the generator of that medical waste; and 

14 ‘‘(2) register with the Administrator. 

15 ‘‘(e) REGISTRATION.—The Administrator may set 

16 appropriate requirements for registration under this sec17 tion and may collect reasonable registration fees from gen18 erators, transporters, and disposal facilities. 

19 ‘‘(f) AVAILABILITY OF FEES.—Subject to appropria20 tions, fees collected under this section shall remain avail21 able for use by the Administrator for purposes of the med22 ical waste management program under this subtitle. 

23 ‘‘SEC. 11003. INSPECTIONS. 

24 ‘‘(a) REQUIREMENTS FOR ACCESS.— 

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1 ‘‘(1) IN GENERAL.—Upon request of any offi2 cer, employee, or representative of the Environ3 mental Protection Agency duly designated by the 

4 Administrator, for purposes of developing or assist5 ing in the development of any regulation or report 

6 under this subtitle or enforcing any provision of this 

7 subtitle, any person who generates, stores, treats, 

8 transports, disposes of, or otherwise handles medical 

9 waste shall furnish information relating to such 

10 waste (including any manifest forms required under 

11 section 11001), conduct monitoring or testing, and 

12 permit such officer, employee, or representative at 

13 all reasonable times to have access to, and to copy, 

14 all records relating to such waste. 

15 ‘‘(2) SPECIFIC ACTIVITIES AUTHORIZED.—To 

16 carry out inspections for purposes of the program 

17 under section 11001, officers, employees, or rep18 resentatives described under paragraph (1) are au19 thorized to— 

20 ‘‘(A) enter at reasonable times any build21 ing, vehicle, equipment, container, or other item 

22 or place where medical waste is generated, 

23 stored, treated, disposed of, or transported; 

24 ‘‘(B) conduct monitoring or testing relat25 ing to such waste; 

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1 ‘‘(C) inspect any such waste and any con2 tainers, labels, and documents relating to such 

3 waste; and 

4 ‘‘(D) obtain from any person— 

5 ‘‘(i) samples of such waste; and 

6 ‘‘(ii) samples or copies of such con7 tainers, labels, and documents. 

8 ‘‘(b) PROCEDURES.— 

9 ‘‘(1) PROMPT INSPECTIONS.—Each inspection 

10 under this section shall be commenced and com11 pleted with reasonable promptness. 

12 ‘‘(2) SAMPLES.— 

13 ‘‘(A) IN GENERAL.—If an officer, em14 ployee, or representative described under sub15 section (a)(1) obtains any samples under sub16 section (a)(2)(D), prior to leaving the site of in17 spection the officer, employee, or representative 

18 shall give to the owner, operator, or agent in 

19 charge a receipt describing each sample ob20 tained. 

21 ‘‘(B) ANALYSIS.—If any analysis is made 

22 of such samples, a copy of the results of such 

23 analysis shall be furnished promptly to the 

24 owner, operator, or agent in charge of the site 

25 from which such sample was taken. 

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1 ‘‘(c) AVAILABILITY TO PUBLIC.—The provisions of 

2 section 3007(b) of this Act shall apply to records, reports, 

3 and information obtained under this section in the same 

4 manner and to the same extent as such provisions apply 

5 to records, reports, and information obtained under sec6 tion 3007. 

7 ‘‘SEC. 11004. FEDERAL ENFORCEMENT. 

8 ‘‘The provisions of section 3008 (except for sub9 section (d)(7) and to the extent such section applies to 

10 used oil) shall apply to a violation of this subtitle, with 

11 respect to medical waste, in the same manner and to the 

12 same extent as such provisions apply to a violation of sub13 title C, with respect to hazardous waste except that any 

14 reference in section 3008 to— 

15 ‘‘(1) section 3006 shall be treated as a ref16 erence to section 11005; 

17 ‘‘(2) a permit under this subtitle shall be treat18 ed as a reference to registration under section 

19 11002; and 

20 ‘‘(3) authorization to operate under section 

21 3005(e) shall be treated as a reference to a registra22 tion under section 11002. 

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1 ‘‘SEC. 11005. AUTHORIZED STATE MEDICAL WASTE PRO2 GRAMS. 

3 ‘‘The provisions of section 3006 (except for sub4 sections (g) and (h) and paragraphs (3) and (4) of sub5 section (c)) shall, to the extent consistent, apply to this 

6 subtitle, with respect to medical waste, in the same man7 ner as such provisions apply to subtitle C, with respect 

8 to hazardous waste, except that any reference in section 

9 3006 to— 

10 ‘‘(1) the date of enactment of this Act shall be 

11 treated as a reference to the date of enactment of 

12 the Medical Waste Management Act of 2011; 

13 ‘‘(2) the date of promulgate of regulations 

14 under sections 3002, 3004, and 3005, shall be treat15 ed as a reference to the date of promulgation of reg16 ulations under section 11001, 11002, and 11003; 

17 and 

18 ‘‘(3) January 31, 1986, shall be treated as a 

19 reference to December 31, 2011. 

20 ‘‘SEC. 11006. SYRINGE DISPOSAL PROGRAM. 

21 ‘‘(a) IN GENERAL.—The Administrator shall estab22 lish a program on syringe disposal to— 

23 ‘‘(1) educate the public about acceptable meth24 ods for disposal of used syringes generated by indi25 viduals through personal use of such syringes outmstockstill on DSK4VPTVN1PROD with BILLS

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1 side of medical facilities, including through house2 hold use; and 

3 ‘‘(2) provide grants to State and local govern4 ments and nonprofit and private entities— 

5 ‘‘(A) to educate the public about such 

6 methods; and 

7 ‘‘(B) to increase access to such disposal 

8 methods. 

9 ‘‘(b) ACCEPTABLE DISPOSAL METHODS.—For pur10 poses of this section, acceptable methods of disposal of 

11 used syringes shall be determined by the Administrator 

12 and may include community drop-off programs, hazardous 

13 waste facilities that accept household waste, mail-back 

14 programs, syringe exchange programs, and needle destruc15 tion devices. 

16 ‘‘(c) UNACCEPTABLE DISPOSAL METHODS.—For 

17 purposes of this section, disposal— 

18 ‘‘(1) in household garbage is not an acceptable 

19 disposal method unless the syringe has been appro20 priately (as determined by the Administrator) steri21 lized and destroyed; and 

22 ‘‘(2) through the sewage system is not an ac23 ceptable disposal method. 

24 ‘‘SEC. 11007. REPORTS TO CONGRESS. 

25 ‘‘(a) ANNUAL REPORT.— 

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1 ‘‘(1) IN GENERAL.—Not later than one year 

2 after the date of enactment of the Medical Waste 

3 Management Act of 2011 and annually thereafter, 

4 the Administrator shall report to Congress on the 

5 following: 

6 ‘‘(A) The types, number, and size of gen7 erators of medical waste in the United States. 

8 ‘‘(B) The types and amounts of medical 

9 waste generated in the United States. 

10 ‘‘(C) The methods currently used to han11 dle, store, transport, treat, and dispose of the 

12 medical waste, including the extent to which 

13 such waste is disposed of in sewer systems. 

14 ‘‘(D) The present and potential costs— 

15 ‘‘(i) to local economies, persons, and 

16 the environment from the improper han17 dling, storage, transportation, treatment, 

18 or disposal of medical waste; and 

19 ‘‘(ii) to generators, transporters, and 

20 storage and disposal facilities from regula21 tions establishing requirements related to 

22 tracking, handling, storing, transporting, 

23 treating, and disposing of medical waste. 

24 ‘‘(E) Available and potentially available 

25 methods for handling, storing, transporting, 

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1 and disposing of medical waste and their advan2 tages and disadvantages. 

3 ‘‘(F) Available and potentially available 

4 methods for treating medical waste, including 

5 methods of sterilization, chemical treatment, 

6 and grinding. 

7 ‘‘(G) The advantages and disadvantages of 

8 such treatment methods, including the extent to 

9 which such methods— 

10 ‘‘(i) render medical waste noninfec11 tious or less infectious; 

12 ‘‘(ii) make medical waste unrecogniz13 able; and 

14 ‘‘(iii) protect human health and the 

15 environment. 

16 ‘‘(H) Factors impacting the effectiveness 

17 of the treatment methods identified in subpara18 graph (F), including quality control and quality 

19 assurance procedures, maintenance procedures, 

20 and operator training. 

21 ‘‘(I) Available and potentially available 

22 methods for the reuse or reduction of the vol23 ume of medical waste generated. 

24 ‘‘(b) STUDY AND REPORT ON INDIVIDUAL GENERA25 TORS.— 

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1 ‘‘(1) STUDY.—The Administrator shall conduct 

2 a study on— 

3 ‘‘(A) the type of medical waste (including 

4 used syringes) generated by individuals through 

5 personal use of medical products outside of 

6 medical facilities; 

7 ‘‘(B) the volume of such waste; 

8 ‘‘(C) the availability and cost of disposal 

9 and treatment of such waste; 

10 ‘‘(D) the impact on the environment and 

11 human health of excluding such waste from the 

12 medical waste management program under sec13 tion 11001; and 

14 ‘‘(E) the extent to which individuals are 

15 aware of and use available disposal and treat16 ment options for such waste. 

17 ‘‘(2) REPORT.—Not later than the last day of 

18 the one-year period beginning on the date of enact19 ment of the Medical Waste Management Act of 

20 2011, the Administrator shall submit a report to 

21 Congress containing— 

22 ‘‘(A) the results of the study under para23 graph (1); 

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1 ‘‘(B) recommended standards for the han2 dling, storage, treatment, and disposal of such 

3 waste; and 

4 ‘‘(C) recommendations for educating the 

5 public about such standards. 

6 ‘‘(c) CONSULTATION.—In preparing the reports 

7 under this section, the Administrator shall consult with 

8 appropriate State and local agencies. 

9 ‘‘SEC. 11008. GENERAL PROVISIONS. 

10 ‘‘(a) CONSULTATION.—(1) In promulgating regula11 tions under this subtitle, the Administrator shall consult 

12 with the States and may consult with other interested par13 ties. 

14 ‘‘(2) The Administrator shall also consult with the 

15 International Joint Commission (as established by the 

16 Boundary Waters Treaty of 1909 between Canada and the 

17 United States) to determine how to track medical waste 

18 entering the United States from Canada. 

19 ‘‘(b) PAPERWORK REDUCTION ACT.—The promulga20 tion of such regulations shall not be subject to the Paper21 work Reduction Act of 1980. 

22 ‘‘(c) RELATIONSHIP TO SUBTITLE C.—Nothing in 

23 this subtitle shall affect the authority of the Administrator 

24 to regulate medical waste under subtitle C of this Act. 

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1 ‘‘SEC. 11009. EFFECTIVE DATE OF REGULATIONS. 

2 ‘‘The regulations promulgated under this subtitle 

3 shall take effect on the last day of the 90-day period begin4 ning on the date such regulations are promulgated.’’. 

5 (c) TABLE OF CONTENTS.—The table of contents for 

6 the Solid Waste Disposal Act is amended by striking the 

7 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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