After many used medical syringes washed up on beaches in the eastern United States, Congress enacted the Medical Waste Tracking Act of 1988, which directed EPA to establish a two-year medical waste demonstration project that would principally affect several northeastern states. The Act amended the Resource Conservation and Recovery Act (RCRA) and EPA promulgated medical waste standards in 1989. (See 54 FR 12326.) The rules were located in EPA’s solid, non-hazardous waste rules at 40 CFR Part 259 (later revoked). These rules followed the standard RCRA format and regulated Generators, Transporters, and Treatment and Disposal Facilities. When the initial batch of EPA’s RCRA Hazardous Waste Rules were promulgated in 1980, EPA decided against designating infectious waste as a hazardous waste. As a result, medical waste was not made subject to the rigorous RCRA regulatory regime. According to EPA, medical waste is a subset of solid wastes generated at health care facilities—principally hospitals—that may be contaminated by blood, bodily fluids or other potentially infectious materials and can take different forms.
The Medical Waste Tracking Act and Its Legacy
EPA concluded that the disease-causing potential of medical waste was greatest at the point of generation, potentially imperiling health care workers as well as patients. The 1989 rules were very thorough and set standards for everyone involved in medical waste management, especially Generators, Transporters, Treatment and Disposal facilities and Mobile Treatment facilities. When the Act expired in 1991, EPA’s direct authority over medical waste management expired as well. Now, medical waste regulation is principally the responsibility of the states, and sometimes supplemented by local authorities. To assist the states, in 1992, EPA developed guidelines entitled “Model Conditions for State Medical Waste Management.” EPA recommended that Generators should perform medical waste characterizations, and recommended that Generators be regulated based on the properties of waste generated rather than exempting “small generators” solely on the basis of the amount of waste generated. EPA also recommended that Generators engage in monitoring, recordkeeping, training, and contingency planning. On-site treatment of their wastes was largely unregulated. Transporters must document their acceptance of a generators’ waste and maintain adequate records. Transporters of untreated waste should notify the pertinent state agency or apply for a registration if required. Treatment and disposal facilities may employ technologies as incineration, electrolysis and chemical disinfection. EPA remarked that treated medical waste could be disposed of in municipal landfills. As noted above, EPA did not require medical waste permits during the brief period the Medical Waste Tracking Act was effective and did not recommend that the states should embark on a permitting regime. Instead, a system of regulatory notifications and registrations was determined to be sufficient.
The Incineration of Medical Waste
Before 1997, it is estimated that 90 percent of potentially infectious waste was incinerated. However, the use of incineration has since fallen out of favor for economic and regulatory reasons. It can be a difficult technology to operate, and it is subject to strict regulation under the Clean Air Act. However, there are other satisfactory treatment technologies to choose from that can render medical waste suitable for landfill disposal such as steam-sterilization, thermal treatment or chemical mechanical systems, among others.
Other Federal Authorities
While EPA’s role in medical waste regulation is now fairly limited (there are some Federal Insecticide, Fungicide, and Rodenticide Act issues relating to medical waste treatment to sort through), other federal agencies such as the Occupational Safety and Health Administration (for workplace safety), the Department of Transportation (packing and shipping requirements), the Drug Enforcement Agency (for controlled pharmaceutical waste) and even the U.S. Postal Service can play important roles in the overall regulation of medical waste.
Regulation in Texas
The Texas Health and Safety Code was amended to define and regulate medical waste. The Code has been amended since that time, but there are other provisions in the Code and the Texas Water Code that address some of the issues of handling medical waste. The initial set of Texas medical waste regulations were codified in the TCEQ rules at 30 TAC Chapter 330, but in 2016, the present medical waste rules were moved to 30 TAC Chapter 326. The agency has issued guidance to clarify the requirements of the medical waste rules. For instance, medical waste is described as “treated and untreated special waste”—an important category for TCEQ—generated from specific sources identified in the rules of the Texas Department of Public Health Safety (TDSHS) and the rules of the U.S. Department of Transportation (49 CFR Section 173.134). While most medical waste regulatory authority is placed in the TCEQ, the TDSHS regulates non-mobile on-site pretreatment of medical waste. There are a number of regulatory exceptions, such as waste produced on a farm or ranch, artificial non-human materials and wastes from homes, hotels and motels. The TCEQ has noted that a mixture of medical waste and hazardous waste will be treated as a hazardous waste under both the EPA and Texas rules.
The rules require generators to conduct waste separation and waste identification. No registration or notification to TCEQ is required. However, in general, operators of medical waste facilities should obtain appropriate authorization for the prevention or abatement of air or water pollution that may be required by federal, state, and local authorities. Transporters of medical waste may obtain a TCEQ “registration by rule” upon application with the agency. Transporters are subject to reporting and recordkeeping requirements, and their facilities must comport with regulatory standards. Operators of medical waste treatment facilities are required to obtain a registration to operate the facility. They can only accept waste that is accompanied by proper shipping documents.
In March 2020, TCEQ released guidance on generating, transporting, treating, and disposing of COVID-19 medical waste. TCEQ’s guidance does not adopt a more stringent approach to COVID-19 medical waste than other regulated medical waste. Instead, generators, transporters, treatment facilities and disposal facilities of COVID-19 medical waste should adhere to existing TCEQ regulations on regulated medical waste.
Regulation in Other States and Jurisdictions
Several states (including Alabama, California, Florida, Maine, New Jersey and Ohio) require all generators of medical waste to register with the state. Some states and counties require generators to prepare facility-specific medical waste management plans and maintain required records. Some counties and local governments operate their own environmental enforcement offices and conduct inspections and take enforcement actions. Harris County, Texas, is an example of a local jurisdiction that is prepared to take vigorous enforcement action if necessary.
As state environmental and health authorities grapple with medical waste generated by COVID-19, agencies such as the New York Department of Environmental Conservation and the New Jersey Department of Environmental Protection have released guidance on COVID-19 medical waste. With regulatory authority over medical waste shared among numerous state and local regulatory authorities, additional guidance on COVID-19 medical waste may be forthcoming.
While EPA has provided a framework to regulate medical wastes at the state and local level, individual states and other local jurisdictions have the flexibility to develop their own regulatory programs in lieu of federal authority. Owners and operators of medical waste facilities should be familiar with the requirements of these regulatory bodies.
For more information, please reach out to your regular Pillsbury contact or the authors of this client alert.
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