[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7163 Introduced in House (IH)]







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 Administrator of 
 the Environmental Protection Agency to promulgate regulations on the 
                      management of medical waste.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Waste Management 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 amended by striking paragraph (40) and 
inserting the following:
            ``(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 research 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 cultures from medical 
                and pathological laboratories, cultures and stocks of 
                infectious agents from research and industrial 
                laboratories, wastes from the production of 
                biologicals, discarded 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.
                    ``(iv) Sharps (as such term is defined by the 
                Secretary) that have been used in patient care or in 
                medical, research, or industrial laboratories, 
                including hypodermic needles, syringes, pasteur 
                pipettes, broken glass, and scalpel 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, including 
                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, laboratory 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, 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 
                contaminated 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.''
            ``(C) Such term does not include any hazardous waste 
        identified or listed under subtitle C or any household waste as 
        defined in regulations under subtitle 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 subtitle J (42 U.S.C. 6992 et seq.) 
and inserting the following:

             ``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 medical waste.
    ``(b) Components of Program.--The program under subsection (a) 
shall provide for the following:
            ``(1) Tracking medical waste from any generator of such 
        waste to any disposal facility that disposes of such waste, 
        including a record keeping system 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 requirement 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, transporters, and 
        disposal facilities provide adequate training to individuals 
        who handle medical waste to ensure compliance with the program 
        under this section.
            ``(8) A national plan for managing medical waste generated 
        in States with a shortage of disposal 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 program under subsection (a) 
                for medical waste treated in a method described under 
                subparagraph (B).
                    ``(B) Methods of treatment.--For purposes of this 
                paragraph, the Administrator shall promulgate 
                regulations establishing minimum standards for methods 
                of treating medical 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 exemption 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 subparagraph (B) and 
                paragraph (4), the Administrator shall make an 
                exemption from the program 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 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 environment and human health can be adequately 
        protected, as determined by the Administrator.
    ``(d) Regulations.--
            ``(1) In general.--Tor purposes of the program under this 
        section, not later than the last day of the 12-month period 
        beginning on the date of enactment of the Medical Waste 
        Management Act of 2008, the Administrator shall promulgate 
        regulations on tracking, labeling, packaging, storing, 
        handling, 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 
              DISPOSAL FACILITIES.

    ``(a) Specific Requirements for Generators.--A generator of medical 
waste shall--
            ``(1) provide any transporter that is transporting medical 
        waste from the generator to a disposal facility--
                    ``(A) with a written assurance that the generator 
                has complied with all labeling, packaging, and storage 
                requirements under section 11001 with respect to such 
                medical waste; and
                    ``(B) with a properly completed manifest form for 
                transporting such waste under section 11001(b)(2);
            ``(2) register with the Administrator; and
            ``(3) provide the Administrator with the name of all 
        transporters used by the generator to transport medical waste.
    ``(b) Specific Requirements for Transporters.--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 methods used to ensure segregation and 
        handling of such waste in accordance with this subtitle.
    ``(c) Specific Requirements for Disposal Facilities.--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 section and may collect 
reasonable registration fees from generators, transporters, and 
disposal facilities.
    ``(e) Availability of Fees.--Subject to appropriations, fees 
collected under this section shall remain available for use by the 
Administrator for purposes of the medical waste management program 
under this subtitle.

``SEC. 11003. INSPECTIONS.

    ``(a) Requirements for Access.--
            ``(1) In general.--Upon request of any officer, employee, 
        or representative of the Environmental Protection Agency duly 
        designated by the Administrator, for purposes of developing or 
        assisting 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 representatives described under 
        paragraph (1) are authorized to--
                    ``(A) enter at reasonable times any building, 
                vehicle, equipment, container, or other item or place 
                where medical waste is generated, stored, treated, 
                disposed of, or transported;
                    ``(B) conduct monitoring or testing relating to 
                such waste;
                    ``(C) inspect any such waste and any containers, 
                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 
                        containers, labels, and documents.
    ``(b) Procedures.--
            ``(1) Prompt inspections.--Each inspection under this 
        section shall be commenced and completed with reasonable 
        promptness.
            ``(2) Samples.--
                    ``(A) In general.--If an officer, employee, or 
                representative described under subsection (a)(1) 
                obtains any samples under subsection (a)(2)(C), prior 
                to leaving the site of inspection the officer, 
                employee, or representative shall give to the owner, 
                operator, or agent in charge a receipt describing each 
                sample obtained.
                    ``(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 to records, reports, and information obtained under 
section 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 $50,000 per day 
                of noncompliance for each violation 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 seriousness of the violation and any 
                good faith efforts 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 Administrator 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 promulgated 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 penalty of not more than $50,000 for each day of 
        continued noncompliance with the order.
    ``(b) Criminal Penalties.--
            ``(1) In general.--Whoever--
                    ``(A) knowingly violates--
                            ``(i) any provision of this subtitle; or
                            ``(ii) regulations promulgated to carry out 
                        this subtitle;
                    ``(B) knowingly omits material information or makes 
                any false material statement or representation in any 
                label, record, report, or other document filed, 
                maintained, or used for purposes of compliance with 
                this subtitle or regulations thereunder; or
                    ``(C) knowingly generates, stores, treats, 
                transports, disposes of, or otherwise handles any 
                medical waste and who knowingly destroys, alters, 
                conceals, or fails to file any record, report, or other 
                document required to be maintained or filed for 
                purposes of compliance with this subtitle or 
                regulations thereunder;
        shall be fined under title XVIII, United States Code, or 
        imprisoned for a maximum of four years (ten years in the case 
        of a violation of subparagraph (A)), or both. Each day of a 
        violation under this paragraph is a separate offense.
            ``(2) Knowing endangerment.--
                    ``(A) In general.--Any person who knowingly 
                violates any provision of paragraph (1) and who knows 
                at the time of such violation that, through such 
                violation, another person is placed in imminent danger 
                of death or serious bodily injury, shall be fined 
                $350,000, or imprisoned for a maximum of 15 years, or 
                both.
                    ``(B) Special rules.--The provisions of section 
                3008(f) of this Act shall apply to this subsection.
    ``(c) Civil Penalties.--
            ``(1) In general.--Any person who violates any provision of 
        this subtitle or regulation promulgated to carry out this 
        subtitle shall be liable to the United States for a civil 
        penalty in an amount not to exceed $50,000 for each such 
        violation.
            ``(2) Repeat violations.--For purposes of this subsection, 
        each day of such violation shall constitute a separate 
        violation.
            ``(3) Policy.--Civil penalties assessed by the United 
        States or by the States under this subtitle shall be assessed 
        in accordance with the Administrator's `RCRA Civil Penalty 
        Policy', as such policy may be amended from time to time.
    ``(d) Subpoenas.--In connection with any proceeding under this 
section, the Administrator may issue subpoenas for the production of 
relevant papers, books, and documents, and may promulgate rules for 
discovery procedures.

``SEC. 11005. RELATIONSHIP TO STATE LAW.

    ``(a) State Inspections and Enforcement.--A State may conduct 
inspections under section 11003 and take enforcement actions under 
section 11004 against any person, including any person who has imported 
medical waste into a State in violation of the requirements of, or 
regulations under, this subtitle, to the same extent as the 
Administrator.
    ``(b) Notification.--At the time a State initiates an enforcement 
action under section 11004 against any person, the State shall notify 
the Administrator in writing.
    ``(c) Preemption.--This subtitle preempts the law of any State to 
the extent such laws are inconsistent with this subtitle, except that 
this subtitle shall not preempt any State law that provides additional 
protections for human health and the environment, as determined by the 
Administrator.
    ``(d) State Forms.--Any State or local law which requires 
submission of a tracking form from any person subject to this subtitle 
shall require that the form be identical in content and format to the 
manifest form required under section 11001, except that a State may 
require the submission of other tracking information which is 
supplemental to the information required on such manifest form through 
additional sheets or such other means as the State deems appropriate.
    ``(e) Retention of State Authority.--Except as provided in 
subsections (c) and (d), nothing in this subtitle shall affect any 
State or local law or the authority of any State or local government to 
adopt or enforce any State or local law.

``SEC. 11006. SYRINGE DISPOSAL PROGRAM.

    ``(a) In General.--The Administrator shall establish a program on 
syringe disposal to--
            ``(1) educate the public about acceptable methods for 
        disposal of used syringes generated by individuals through 
        personal use of such syringes outside of medical facilities, 
        including through household use; and
            ``(2) provide grants to State and local governments 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 purposes 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 destruction devices. 
Disposal in household garbage is not an acceptable disposal method.

``SEC. 11007. REPORTS TO CONGRESS.

    ``(a) Annual Report.--
            ``(1) In general.--Not later than one year after the date 
        of enactment of the Medical Waste Management Act of 2008 and 
        annually thereafter, the Administrator shall report to Congress 
        on the following:
                    ``(A) The types, number, and size of generators 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 handle, 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 handling, 
                        storage, transportation, treatment, or disposal 
                        of medical waste; and
                            ``(ii) to generators, transporters, and 
                        treatment, storage, and disposal facilities 
                        from regulations establishing requirements 
                        related to tracking, handling, storing, 
                        transporting, treating, and disposing of 
                        medical waste.
                    ``(E) Available and potentially available methods 
                for handling, storing, transporting, and disposing of 
                medical waste and their advantages 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 noninfectious or 
                        less infectious;
                            ``(ii) make medical waste unrecognizable; 
                        and
                            ``(iii) protect human health and the 
                        environment.
                    ``(H) Factors impacting the effectiveness of the 
                treatment methods identified in subparagraph (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 volume of medical 
                waste generated.
                    ``(J) The appropriateness of the penalties provided 
                in section 11004 for insuring compliance with the 
                requirements of this subtitle, including a review of 
                the level of penalties imposed under this subtitle.
    ``(b) Study and Report on Individual Generators.--
            ``(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 section 11001; and
                    ``(E) the extent to which individuals are aware of 
                and use available disposal and treatment options for 
                such waste.
            ``(2) Report.--Not later than the last day of the one-year 
        period beginning on the date of enactment of the Medical Waste 
        Management Act of 2008, the Administrator shall submit a report 
        to Congress containing--
                    ``(A) the results of the study under paragraph (1);
                    ``(B) recommended standards for the handling, 
                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 regulations under this 
subtitle, the Administrator shall consult with the States and may 
consult with other interested parties.
    ``(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) Public Comment.--In the case of the regulations required by 
this subtitle to be promulgated within nine months after the date of 
enactment of the Medical Waste Management Act of 2008, the 
Administrator may promulgate such regulations in interim final form 
without prior opportunity for public comment, but the Administrator 
shall provide an opportunity for public comment on the interim final 
rule.
    ``(c) Paperwork Reduction Act.--The promulgation of such 
regulations shall not be subject to the Paperwork Reduction Act of 
1980.
    ``(d) 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.

``SEC. 11009. EFFECTIVE DATE OF REGULATIONS.

    ``The regulations promulgated under this subtitle shall take effect 
on the last day of the 90-day period beginning 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 
                            disposal facilities.
``Sec. 11003. Inspections.
``Sec. 11004. Enforcement.
``Sec. 11005. Relationship to State law.
``Sec. 11006. Syringe Disposal Program.
``Sec. 11007. Reports to Congress.
``Sec. 11008. General provisions.
``Sec. 11009. Effective date of regulations.''.
                                 <all>