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Overview
Regulated medical waste
(RMW), also known as 'biohazardous' waste or 'infectious
medical' waste, is the portion of the waste stream that may be contaminated
by blood, body fluids or other potentially infectious
materials, thus posing a significant risk of transmitting infection.
There are no specific regulations that flatly prohibit the import/export of medical waste; however, several federal agencies and most states have rules that apply to transportation and/or disposal of medical waste, and therefore can affect transboundary movement of this material. Also, be aware that hazardous waste pharmaceuticals and medical waste that meets the definition of hazardous waste, fall under RCRA hazardous waste rules. See EPA guidance for more information on this subject.
Of particular importance to transporters are state
medical waste regulations and Department of Transportation (DOT) regulations. Occupational
Safety and Health and EPA rules also apply to medical waste and these are
also discussed below.
With regard to transboundary
movement of medical waste, one particular issue that has been publicized
is importation of mixed municipal
solid waste (MSW)/medical waste from Canada into Michigan. Importation
of MSW is permissible under interstate commerce laws; however, DOT and
state rules prohibit medical waste transportation without a special permit.
Customs and Border Protection (CBP) are on the lookout for prohibited materials,
such as medical waste in
MSW vehicles entering the U.S. In addition to close inspections at the
border crossing, a representative number of the municipal solid waste
trucks are inspected at the landfills where the waste is destined for
disposal. CBP officers escort the trucks to the landfill and inspect
the contents when it's unloaded. Municipal solid waste trucks carrying
medical waste are refused entry into the United States and are returned
to Canada.
Regulations
State Medical Waste Regulations. Nearly all 50
states have enacted medical waste regulations to some extent that regulate
certain wastes generated by healthcare facilities (household medical waste
is exempt from regulations in all states). Most states have regulations covering
packaging, storage, and transportation (in some cases manifests) of medical
waste. Some states require health care facilities to register and/or obtain
a permit. State rules may also cover the development of contingency plans,
on-site treatment, training, waste tracking, recordkeeping, and reporting. [To
locate medical waste regulations for a specific state, go to the HERC State RMW Resource Locator.]
DOT Regulations. Regulated medical waste is defined by the Department
of Transportation as a hazardous material. The DOT rules apply to whenever
medical waste is in transit, including transboundary shipping.
Under DOT rules, regulated
medical waste means "a waste or reusable material known to contain
or suspected of containing an infectious substance in Risk Group 2 or
3 and
generated in the diagnosis, treatment, or immunization of human beings
or animals; research on the diagnosis, treatment or immunization of human
beings or animals; or the production or testing of biological products."
(see 49
CFR 173.134(a)(5)).
Materials meeting the
definition of a regulated medical waste must be transported in conformance
with the regulations for RMW (49
CFR 173.197). However, a material that previously contained an infectious
substance that has been treated by steam sterilization, chemical disinfection,
or other appropriate method, so it no longer meets the definition of an
infectious substance is exempt from the DOT rules.
OSHA Regulations. OSHA,
whether it is the U.S. Department of Labor Occupational Safety & Health
Administration or an OSHA state program (24 states operate their own program),
regulates several aspects
of medical waste, including management of sharps, requirements for containers
that hold or store medical waste, labeling of medical waste bags/containers,
and employee training. These standards are designed to protect healthcare
workers from the risk of exposure
to bloodborne pathogens. [See HERC OSHA
Standards for Bloodborne Pathogens]
US EPA Regulations. During
the 1980's, the public became aware that
used syringes and similar wastes had been found washing up on several East
Coast beaches. In response, Congress enacted the Medical Waste
Tracking Act (MWTA), which required EPA to create a two-year medical
waste demonstration program. The resultant standards for tracking and management
of medical waste were in effect in four states (New York, New Jersey, Connecticut,
Rhode Island), and in Puerto Rico, from June 1989 to June 1991. From the
information gathered during this period, EPA concluded that the disease-causing
potential of medical waste is greatest at the point of generation and naturally
tapers off after that point. Medical waste could therefore be considered
more of an occupational concern than an environmental concern
affecting the general public. The regulations promulgated under the MWTA
expired on June 21, 1999.
Although EPA no longer plays a central role with medical waste management,
EPA has active regulations governing
emissions from hospital/medical/infectious waste incinerators as well
as requirements under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) for certain medical
waste treatment technologies that use chemicals for treating the waste.
More Resources
EPA Medical Waste webpage. Contains
links to various federal and state resources related to medical waste.
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