H. R. 2552
IN THE HOUSE OF REPRESENTATIVES
May 21, 2009
Mr. Pallone introduced the following bill; which was referred to the Committee on Energy and Commerce
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.
This Act may be cited as the
Medical Waste Management Act of
Tracking and disposal of medical waste
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:
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.
Such term includes the following types of solid waste:
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.
Pathological waste, including tissues, organs, and body parts that are removed during surgery or autopsy.
Waste human blood and products of blood, including serum, plasma, and other blood components.
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.
Contaminated carcasses, body parts, and bedding of animals that have been exposed to infectious agents during research, production of biologicals, or testing of pharmaceuticals.
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.
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.
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.
Discarded medical equipment and parts that have been in contact with infectious agents.
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.
Solid waste generated during—
the diagnosis or treatment of disease in human beings or animals;
the provision of medical services (including immunizations) to human beings or animals;
post-mortem clean-up or autopsy preparations for human beings or animals;
medical research on human beings or animals;
the operation of a syringe exchange program; or
the production or testing of a biological product (as defined in section 351 of the Public Health Service Act (42 U.S.C. 262)).
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.
Not later than the last day of the two-year period beginning on the date of enactment of the Medical Waste Management Act of 2009, the Administrator shall promulgate regulations listing types of medical waste.
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:
Medical Waste Management Program
Medical waste management program
The Administrator shall conduct a medical waste management program for the purpose of protecting human health and the environment from medical waste.
Components of program
The program under subsection (a) shall provide for the following:
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.
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.
Labeling and packaging requirements that—
foster safe handling of the waste;
protect the public from exposure to infectious disease; and
provide for the identification of the generator of the waste.
Storage requirements, including a requirement for segregation of the waste at the point of generation and during transportation.
Proper disposal of medical waste through appropriate methods of disposal that—
are approved by the Administrator; and
provide adequate protection for the environment and human health.
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.
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.
A national plan for managing medical waste generated in States with a shortage of disposal facilities.
Properly treated waste
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).
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.
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.
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.
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.
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.
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 2009, the Administrator shall promulgate regulations on tracking, labeling, packaging, storing, handling, monitoring, and disposing of medical waste.
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.
Specific requirements for generators, transporters, and storage and disposal facilities
Specific requirements for generators
A generator of medical waste shall—
provide any transporter that is transporting medical waste from the generator to a disposal facility—
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
with a properly completed manifest form for transporting such waste under section 11001(b)(2);
register with the Administrator; and
provide the Administrator with the name of all transporters used by the generator to transport medical waste.
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.
Specific requirements for transporters
A transporter of medical waste shall—
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);
register with the Administrator; and
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.
Specific requirements for storage facilities
An owner or operator of a storage facility shall—
provide notice of the storage of medical waste to the generator of that medical waste; and
register with the Administrator.
Specific requirements for disposal facilities
An owner or operator of a disposal facility shall—
provide notice of the disposal of medical waste to the generator of that medical waste; and
register with the Administrator.
The Administrator may set appropriate requirements for registration under this section and may collect reasonable registration fees from generators, transporters, and disposal facilities.
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.
Requirements for Access
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.
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—
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;
conduct monitoring or testing relating to such waste;
inspect any such waste and any containers, labels, and documents relating to such waste; and
obtain from any person—
samples of such waste; and
samples or copies of such containers, labels, and documents.
Each inspection under this section shall be commenced and completed with reasonable promptness.
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.
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.
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.
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—
section 3006 shall be treated as a reference to section 11005;
a permit under this subtitle shall be treated as a reference to registration under section 11002; and
authorization to operate under section 3005(e) shall be treated as a reference to a registration under section 11002.
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—
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 2009;
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
January 31, 1986, shall be treated as a reference to December 31, 2011.
Syringe Disposal Program
The Administrator shall establish a program on syringe disposal to—
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
provide grants to State and local governments and nonprofit and private entities—
to educate the public about such methods; and
to increase access to such disposal methods.
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.
Unacceptable disposal methods
For purposes of this section, disposal—
in household garbage is not an acceptable disposal method unless the syringe has been appropriately (as determined by the Administrator) sterilized and destroyed; and
through the sewage system is not an acceptable disposal method.
Reports to Congress
Not later than one year after the date of enactment of the Medical Waste Management Act of 2009 and annually thereafter, the Administrator shall report to Congress on the following:
The types, number, and size of generators of medical waste in the United States.
The types and amounts of medical waste generated in the United States.
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.
The present and potential costs—
to local economies, persons, and the environment from the improper handling, storage, transportation, treatment, or disposal of medical waste; and
to generators, transporters, and storage and disposal facilities from regulations establishing requirements related to tracking, handling, storing, transporting, treating, and disposing of medical waste.
Available and potentially available methods for handling, storing, transporting, and disposing of medical waste and their advantages and disadvantages.
Available and potentially available methods for treating medical waste, including methods of sterilization, chemical treatment, and grinding.
The advantages and disadvantages of such treatment methods, including the extent to which such methods—
render medical waste noninfectious or less infectious;
make medical waste unrecognizable; and
protect human health and the environment.
Factors impacting the effectiveness of the treatment methods identified in subparagraph (F), including quality control and quality assurance procedures, maintenance procedures, and operator training.
Available and potentially available methods for the reuse or reduction of the volume of medical waste generated.
Study and report on individual generators
The Administrator shall conduct a study on—
the type of medical waste (including used syringes) generated by individuals through personal use of medical products outside of medical facilities;
the volume of such waste;
the availability and cost of disposal and treatment of such waste;
the impact on the environment and human health of excluding such waste from the medical waste management program under section 11001; and
the extent to which individuals are aware of and use available disposal and treatment options for such waste.
Not later than the last day of the one-year period beginning on the date of enactment of the Medical Waste Management Act of 2009, the Administrator shall submit a report to Congress containing—
the results of the study under paragraph (1);
recommended standards for the handling, storage, treatment, and disposal of such waste; and
recommendations for educating the public about such standards.
In preparing the reports under this section, the Administrator shall consult with appropriate State and local agencies.
In promulgating regulations under this subtitle, the Administrator shall consult with the States and may consult with other interested parties.
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.
Paperwork Reduction Act
The promulgation of such regulations shall not be subject to the Paperwork Reduction Act of 1980.
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.
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.
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.