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RCRA Medical Waste Requirements
- The Statute
- Medical Waste Management Regulation
- Other Federal Laws and Regulations Relating to Medical Waste Management
- State Medical Waste Management Laws and Regulations
Medical Waste, if determined to be hazardous is regulated by the Resource Conservation and Recovery Act of 1976 (RCRA) under Subtitle C for hazardous wastes, and these wastes were, for a two year period, also regulated in specified states under RCRA Subtitle J. RCRA Subtitle J expired on March 22, 1991. Other aspect of medical waste management are regulated under the Clean Air Act (CAA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (see below).
Because of widespread mismanagement, medical wastes began washing ashore along the Atlantic Coast during the summer of 1988. Congress enacted the Medical Waste Tracking Act of 1988 (MWTA) in November of that year which established Subtitle J that was added to RCRA. RCRA Subtitle J instructed EPA to develop a two-year demonstration program for tracking medical wastes from generation through disposal in specific governmental entities that chose to participate in the program (New Jersey, New York, Puerto Rico, and Rhode Island). The Act also required EPA to submit two interim reports and a final report on the demonstration program to Congress.
EPA established regulations and regulatory requirements for generators, transporters, destruction facilities, and disposal facilities in March 1989. The regulations were originally at 40 C.F.R. Part 259, but since have been removed from the Code of Federal Regulations (C.F.R.) because of the expiration of the program.
Part 259, Management of Medical Waste, was added to RCRA in 1989. A medical waste is defined as any solid waste which is generated in the diagnosis, treatment, or immunization of human beings or animals, in related research, biologicals production, or testing. Information on the requirements for managing medical wastes and information about the demonstration project are available through the following links:
Medical Waste Demonstration Project (Expired)
Other Medical Waste Information
Since the expiration of the federal RCRA Subtitle J medical waste tracking and management program, the states have become active in managing medical wastes and the majority have developed programs similar to the federal model.
RCRA Subtitle C's Medical Waste Management Regulation
Since medical wastes meet the RCRA regulatory definition of a solid waste, they are subject to the Subtitle C hazardous waste characterization. When a facility identifies a waste as medical waste, it then must to determine if the waste is a RCRA listed waste or a RCRA characteristic waste, either of which would classify the wastes as hazardous and subject to the RCRA Subtitle C hazardous waste regulation and requirements. They then have to meet the RCRA Subpart 264 requirement for generators and the RCRA Subpart 265 requirements for transporters, storage, and disposal facilities (TSDFs). If the wastes are not a RCRA listed wastes or RCRA characteristic wastes, they are classifed as nonhazardous and are regulated under RCRA Subtitle D for solid wastes which does not include tracking requirements. However, during the period that the Subtitle J medical waste tracking and management requirements were in place, these medical wastes were excluded from the tracking requirements of Subtitle J but were made subject to the requirements of RCRA Subtitle C. In summary, at the current time, medical wastes that are a RCRA Subtitle C listed waste or RCRA Subtitle C characteristic wastes are regulated as Subtitle C hazardous wastes and are subject to the requirements for these wastes.
Other Federal Laws and Regulations Relating to Medical Waste Management
Clean Air Act of 1970, as Amended (CAA)
EPA, in 1997, established new source performance standards (NSPS) and emissions guidelines to reduce air emissions from new and existing hospital, infectious, and medical waste incinerators. These guidelines also established standards for incinerator operator training and qualifications, equipment inspections, and siting. (CAA Enforcement Information)
Federal Insecticide, Fungicide, and Rodenticide Act of 1947 (FIFRA)
Antimicrobial, pesticides and disinfectants used in medical waste treatment technologies, under FIFRA, must be registered with EPA. (FIFRA Enforcement Information)
Occupational Safety and Health Act (OSHA) -- OSHA regulates employee exposure to hazardous chemicals in the workplace. RCRA hazardous waste generators and TSDFs may need to comply with OSHA training and planning standards (e.g. 29 C.F.R. 1910.1200, 29 C.F.R. 1910.120, 29 C.F.R. 1910.38); RCRA hazardous waste operations and RCRA corrective action activities at generator facilities and TSDFs also may need to comply with health and safety training requirements, as do CERCLA remediations (site clean ups). (OSHA Enforcement Information)
The U.S. Department of Transportation and EPA, under RCRA, both regulates the transportation of hazardous wastes and hazardous materials. State Departments of Transportation are primarily responsible the enforcement through their own laws and regulations. Two of the most important requirements are the proper labeling and placarding of materials being shipped. Special conditions are imposed on the shipment of medical etiologic materials.
Other Federal Agencies -- Several other agencies either regulate medical wastes or have an expressed interest in medical wastes in the workplace, in the postal service, in the transportation services, etc. Links are provided on the Office of Solid Waste's Medical Waste web page.
State Medical Waste Management Laws and Regulations
The Resource Conservation and Recovery Act (RCRA) provided the federal government with the authority to authorize states to implement and enforce hazardous waste regulations as long as the state programs are as stringent or broader in scope than the federal regulations. This includes programs managing medical wastes if they qualify as RCRA hazardous wastes.
The authorized states conduct the majority of inspections and initiate enforcement actions with regard to the their medical waste management regulations. If regulated under RCRA Subtitle C, the state regulations often differ from the federal regulations and requirements. Many states have also developed and implements their own laws and regulations governing medical wastes that may or may not parallel those at the federal level. If you have questions about medical waste regulations and requirements, it is advisable for you to contact your state's regulatory agencies.