[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2891 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2891
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 31, 2013
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
2013''.
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 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 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.
``(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) Waste from surgery or autopsy that has been
in contact with infectious agents, including 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, laboratory coats, and
aprons.
``(viii) Dialysis waste that has 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 waste that is 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.
``(xi) Solid waste generated during--
``(I) the diagnosis or treatment of disease
in human beings or animals;
``(II) the provision of medical services
(including immunizations) to human beings or
animals;
``(III) post-mortem clean-up or autopsy
preparations for human beings or animals;
``(IV) medical research on human beings or
animals;
``(V) the operation of a syringe exchange
program; or
``(VI) the production or testing of a
biological product (as defined in section 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 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 2013, 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 recordkeeping 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 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, transporters, and
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 storage 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.
``(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 exemption does not endanger the environment or human
health, as determined by the Administrator.
``(d) Regulations.--
``(1) In general.--For purposes of the program under this
section, not later than the last day of the one-year period
beginning on the date of enactment of the Medical Waste
Management Act of 2013, 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
STORAGE AND DISPOSAL FACILITIES.
``(a) Specific Requirements for Generators.--
``(1) In general.--A generator of medical waste shall--
``(A) provide any transporter that is transporting
medical waste from the generator to a disposal
facility--
``(i) 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
``(ii) with a properly completed manifest
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 (including a tattoo parlor) shall be
considered to be a generator of medical waste for purposes of
this subtitle.
``(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 Storage Facilities.--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 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.
``(e) Registration.--The Administrator may set appropriate
requirements for registration under this section and may collect
reasonable registration fees from generators, transporters, and
disposal facilities.
``(f) 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)(D), 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. FEDERAL ENFORCEMENT.
``The provisions of section 3008 (except for subsection (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 subtitle C, with respect to hazardous waste except that any
reference in section 3008 to--
``(1) section 3006 shall be treated as a reference to
section 11005;
``(2) a permit under this subtitle shall be treated 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 registration under section
11002.
``SEC. 11005. AUTHORIZED STATE MEDICAL WASTE PROGRAMS.
``The provisions of section 3006 (except for subsections (g) and
(h) and paragraphs (3) and (4) of subsection (c)) shall, to the extent
consistent, apply to this subtitle, with respect to medical waste, in
the same manner 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 2013;
``(2) the date of promulgate of regulations under sections
3002, 3004, and 3005, shall be treated as a reference to the
date of promulgation of regulations under section 11001, 11002,
and 11003; and
``(3) January 31, 1986, shall be treated as a reference to
December 31, 2013.
``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.
``(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 appropriately (as determined
by the Administrator) sterilized and destroyed; and
``(2) through the sewage system 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 2013 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
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.
``(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 2013, 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) Paperwork Reduction Act.--The promulgation of such
regulations shall not be subject to the Paperwork 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.
``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
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.''.
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