1.This Act may be cited as the
Medical Waste Management Act of
2011
.
2.Tracking and
disposal of medical waste
(a)Definition of
medical wasteSection 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
2011, the Administrator shall promulgate regulations listing
types of medical
waste.
.
(b)Amendment of
Solid Waste Disposal
ActThe
Solid Waste Disposal Act is amended
by striking subtitle J (42 U.S.C. 6992 et seq.) and inserting the
following:
JMedical Waste
Management Program
11001.Medical waste
management program
(a)The Administrator shall conduct a medical waste
management program for the purpose of protecting human health and the
environment from medical waste.
(b)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)
(1)
(A)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)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)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)
(A)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 wasteThe 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 healthThe 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)
(1)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
2011, the Administrator shall promulgate regulations on tracking,
labeling, packaging, storing, handling, monitoring, and disposing of medical
waste.
(2)The regulations under paragraph (1) may include different
rules for different types of medical waste and for different types of medical
waste generators.
11002.Specific
requirements for generators, transporters, and storage and disposal
facilities
(a)Specific
requirements for generators
(1)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 establishmentsA 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 transportersA 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 facilitiesAn 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 facilitiesAn 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)The
Administrator may set appropriate requirements for registration under this
section and may collect reasonable registration fees from generators,
transporters, and disposal facilities.
(f)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.
11003.
(a)
(1)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 authorizedTo
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)
(1)Each inspection under this section shall be commenced
and completed with reasonable promptness.
(2)
(A)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)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)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.
11004.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.
11005.Authorized
State medical waste programsThe 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
2011;
(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, 2011.
11006.
(a)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 methodsFor 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 methodsFor 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.
11007.
(a)
(1)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 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)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)Not
later than the last day of the one-year period beginning on the date of
enactment of the Medical Waste Management Act
of 2011, 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)In
preparing the reports under this section, the Administrator shall consult with
appropriate State and local agencies.
11008.
(a)(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)The promulgation of such regulations shall not be
subject to the Paperwork Reduction Act of 1980.
(c)Relationship to
Subtitle CNothing in this
subtitle shall affect the authority of the Administrator to regulate medical
waste under subtitle C of this Act.
11009.Effective
date of regulationsThe
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)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.
.