Medical Waste


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.


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 and HERC OSHA state resource locator.

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.