Forthcoming Environmental Regulations Affecting the Health Care Industry

The U.S. Environmental Protection Agency (EPA) recently proposed two new regulations that would have a significant impact on the health care industry, and is moving toward issuing a third. The two proposed regulations would affect air emissions from medical waste incinerators and disposal practices for waste pharmaceuticals. In addition, EPA is studying the need for regulations controlling wastewater discharged from facilities in the health care industry.

Proposed Rule Governing Hospital/Medical/Infectious Waste Incinerators
Earlier this month, EPA issued a proposed rule that would significantly tighten the existing Clean Air Act (CAA) limits on air emissions from hospital/medical/infectious waste incinerators, in response to a remand from the U.S. Court of Appeals for the D.C. Circuit. 73 Fed. Reg. 72962 (Dec. 1, 2008).

The existing limits were promulgated in 1997, and required compliance for all covered sources by September 2002. The Sierra Club and the Natural Resources Defense Council sought judicial review of the 1997 regulations and, in 1999, the D.C. Circuit remanded the rule to EPA for explanation of its reasoning in setting the “floors,” or minimum level of stringency the regulations must achieve. The court did not vacate the regulations, so the 1997 regulations currently remain in effect. EPA issued its first proposed response to the court’s remand in February 2007. However, following several recent D.C. Circuit decisions rejecting EPA’s approach to setting “floors” for being more flexible than the CAA allows, EPA chose to reassess its February 2007 response and issued a replacement proposal on December 1, 2008.

EPA’s December 1, 2008 proposal would tighten the current emission limits for both existing (40 C.F.R. Part 60, Subpart CE) and new (40 C.F.R. Part 60, Subpart EC) hospital/medical/infectious waste incinerators. The regulations establish emission limits for nine pollutants (particulate matter, carbon monoxide, dioxins/furans, hydrogen chloride, sulfur dioxide, nitrogen oxides, lead, cadmium, and mercury) as well as opacity. The proposal would also modify the rule’s provisions for inspections, performance testing, monitoring, and recordkeeping. The proposal is anticipated to result in a reduction of 468,000 pounds of pollutant emissions annually.

Covered sources are devices used to burn hospital waste or medical/infectious waste. Hospital waste means discards generated at a hospital and medical/infectious waste means any waste generated in the diagnosis, treatment, or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals.

Proposed Rule Governing Waste Pharmaceuticals
Also earlier this month, EPA issued a proposed rule to classify hazardous waste pharmaceuticals as “universal waste” under the Resource Conservation and Recovery Act (RCRA). 73 Fed. Reg. 73520 (December 2, 2008). The proposal is anticipated to affect more than 600,000 facilities, including more than 7,000 hospitals and 300,000 physician and dental offices.

The proposed rule would reduce the regulatory burden on hazardous waste pharmaceuticals by classifying them as universal wastes. Many common pharmaceuticals, including certain chemotherapy agents, nitroglycerin, and warfarin, are considered hazardous waste when disposed and, therefore, are subject to detailed and burdensome RCRA requirements. RCRA regulations govern all aspects of handling, storage, transportation, and disposal of hazardous waste. Universal wastes are subject to more flexible and streamlined regulatory requirements under the RCRA program, including simplified labeling and training requirements, longer accumulation time limits, and no manifest requirements. 

The proposal would define “pharmaceutical” as “any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine, or allergenic), not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or . . . that is intended to affect the structure or function of the body in man or other animals.” 73 Fed. Reg. at 73542 (proposed 40 C.F.R. § 260.10). The definition is meant to include pills, tablets, medicinal gums or lozenges, medicinal liquids, ointments, and lotions, intravenous solutions, chemotherapy drugs, vaccines, allergenics, medicinal shampoos, antiseptics, and medicinal dermal patches. The definition excludes sharps or other infectious or biohazardous waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, contaminated personal protective equipment, or contaminated cleaning materials. 73 Fed. Reg. at 73523.

According to EPA, the goal of the proposal is to ensure the proper disposal of pharmaceuticals due to a concern with the potential for mismanagement. Hazardous waste pharmaceuticals may be inappropriately sent for regular landfill disposal since they are often generated in many locations across a facility in relatively small quantities by many individuals. Furthermore, not all pharmaceuticals are hazardous waste under RCRA, but most health care workers generating the waste have not been trained in making hazardous waste determinations. Additionally, many facilities dispose of pharmaceutical wastes down the drain or toilet. Although waste that is disposed to a sanitary sewer system is exempt from regulation under RCRA, EPA “generally considers sewer disposal inadvisable for pharmaceuticals and discourages this practice, unless specifically required by the label.” 73 Fed. Reg. at 73525. This issue is discussed more fully in the following section. By facilitating the collection and disposal of pharmaceuticals, the new universal waste proposal could divert such waste from sanitary sewer disposal.

Comments are due on the proposed rule on or before February 2, 2009. Once EPA issues a final rule, states that have been authorized to implement the RCRA program in lieu of EPA would have to adopt an equivalent rule in order for it to take effect.

Potential Regulation of Wastewater Discharge From the Health Care Industry
EPA also has indicated that it is moving toward imposing controls on the health care industry’s pharmaceutical disposal practices under the Clean Water Act (CWA). 73 Fed. Reg. 53218, 53234-37 (Sept. 15, 2008). Under the CWA, EPA controls both “direct” discharges to waterways (such as a pipe leading directly to a river, lake, or ocean), and “indirect” discharges to publicly owned treatment works (such as a pipe leading to the municipal sewer system), which, in turn, discharge to waterways after treating the collected wastewater.

In a recent Federal Register notice, EPA announced that it is actively considering the health services industry for indirect discharge regulations known as pretreatment standards. 73 Fed. Reg. at 53219. Although EPA previously promulgated direct discharge standards for hospitals, it has never before regulated indirect discharge from this industry.

EPA is including the following sectors within the health care industry in its study of the need for indirect discharge standards: offices and clinics of dentists, doctors, and mental health practitioners; nursing and personal care facilities; hospitals, hospices, and clinics; medical laboratories and diagnostic centers; and veterinary care services.

In its study of the issue to date, EPA has found that it is standard practice at many health care facilities to dispose of unused pharmaceuticals by flushing them down the toilet or drain. Furthermore, some federal regulations such as the Controlled Substances Act inadvertently encourage sewer disposal of pharmaceuticals (e.g., by establishing witnessed disposal of controlled substances to a toilet as an acceptable method of destruction). However, it appears this method of disposal may be harming the nation’s waterways. Recent studies have indicated that pharmaceutical wastes are passing through sewage treatment plants and ending up in surface water and groundwater.

To aid in its decision-making, EPA is currently conducting research on the presence of pharmaceuticals in waterbodies, the ecological effects this may be causing, and means of improving water treatment capabilities. In addition, EPA is studying current disposal practices and best management practices for reducing or eliminating sanitary sewer disposal. EPA will also be collecting technical and economic information on pharmaceutical management through an information collection request. EPA published a separate Federal Register notice soliciting comment on the scope of the request. 73 Fed. Reg. 46903 (Aug. 12, 2008). Health care industry facilities may expect to see this survey in the coming months.

Legal News Alert is part of our ongoing commitment to providing up-to-the-minute information about pressing concerns or industry issues affecting our clients and colleagues.

If you have any questions about this alert or would like to discuss the topic further, please contact your Foley attorney or the following individuals:

Julie Solmer Stine
Milwaukee, Wisconsin
414.319.7311
[email protected] 

Richard G. Stoll
Washington, D.C.
202.295.4021
[email protected]