Louisville Bar Briefs
May 2009
By Ronald R. Van Stockum, Jr., Esq., Attorney at Law1
and LaJuana S. Wilcher, Esq., Attorney at Law2
“Repugnant, intolerable, unacceptable.” That was the response of Congress in 1988 to the wash-up on New England beaches of medical debris such as needles, syringes, blood bags, bandages and vials. “Floatables,” they were called. Caught up on sandbars, they were refloated with the tide and washed ashore. The U.S. Environmental Protection Agency (EPA) later surmised that the likely source of much of this material was from improper disposal of ordinary trash and sewer overflows containing waste from home health care and illegal drug use. Regardless, Congress looked to the medical community and to the existing federal hazardous waste law, the Resource Conservation and Recovery Act (RCRA), to craft legislation designed to address this issue. Called the Medical Waste Tracking Act of 1988 (MWTA), it established a two-year “cradle-to-grave” tracking program in four states (New York, New Jersey, Connecticut, Rhode Island) and Puerto Rico as a pilot study for the regulation of 1 Mr. Van Stockum is the current Chair of the Louisville Bar Association Environmental Law Section. 2 Ms. Wilcher is the former Assistant Administrator for Water in the U.S. Environmental Protection Agency in Washington, D.C. and most recently served as Secretary of the Kentucky Environmental and Public Protection Cabinet, heading up the state environmental agencies. She is a partner at English, Lucas, Priest & Owsley, L.L.P. in Bowling Green. THIS IS AN ADVERTISEMENT
Hospitals are known for treating the sick and saving human lives. Accordingly, it is understood that hospitals are dealing with waste material of an infectious nature. Because of the vast array of functions performed by hospitals, however, the many requirements of our “mainstream” environmental protection laws come into play and are applicable. The following describes briefly the history of the MWTA and key environmental laws and regulations hospitals must address today. The MWTA regulations defined “Medical Waste” as, “… any solid waste which
is generated in the diagnosis, treatment (e.g., provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals.” It excluded hazardous waste or household waste (a defined term) from its definition. The regulations defined an “Infectious Agent” as, “…
any organism (such as a virus or a bacteria) that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease or adverse health impacts in humans,” and “Biologicals” to mean, “… preparations made from
living organisms and their products, including vaccines, cultures, etc., intended for use in diagnosing, immunizing or treating humans or animals or in research pertaining thereto.” The pilot program concluded in 1991. The underlying regulations expired in 1999. No permanent national system of regulation was developed from this pilot program. On June 24, 1998, however, EPA and the American Hospital Association entered into a partnership to work on voluntary efforts to eliminate mercury waste in hospitals, significantly reduce the volume of hospital waste, and identify additional pollution prevention activities. This partnership was called “Hospitals for a Health Environment (H2E)” and developed a webpage with a clearinghouse of information. In THIS IS AN ADVERTISEMENT
2001, the American Hospital Association terminated the agreement. In 2006, the organization became an independent not-for-profit organization. The H2E webpage now routes one to the website for “Practice Green Health” which describes itself as, “… the nation’s leading membership and networking organization for institutions in the healthcare community that have made a commitment to sustainable, eco-friendly, practices.” (See The Kentucky Occupational Safety and Health Office (KYOSH), of the Kentucky Department of Labor, regulates the workplace with standards, compliance, education, training and industrial hygiene consultation. Kentucky has adopted the federal OSHA definition of “Regulated Waste” as, “… liquid or semi-liquid blood or other potentially
infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.” Federal OSHA and KYOSH regulate the exposure, management and disposal of “Bloodborne Pathogens” under the provisions of 29 CFR § 1910.1030.
Over the past several years, the U.S. Environmental Protection Agency has focused on hospital environmental compliance as one of its priorities. The agency has been performing training seminars for hospital representatives in the proper practices of environmental compliance, including compliance with air pollution, hazardous and toxic waste, water pollution and asbestos abatement requirements. The agency conducted such training in the state of Kentucky in 2008. It now appears that EPA is beginning to THIS IS AN ADVERTISEMENT
examine hospital compliance with environmental regulations from an enforcement perspective. EPA may be seeking environmental audits of hospitals, reporting of violations and appropriate enforcement penalties as a result. The majority of environmental violations at hospitals appear to concern RCRA solid, hazardous, and universal waste. Hospital hazardous wastes can include specifically listed wastes described in 40 CFR 261.33 as either “U” or “P” listed hazardous wastes. They include the chemotherapy drug chlorambucil (U035), the cancer-treating drug streptozotocin (U206), and the “P” listed biocide, sodium azide (P105). Regulated hazardous wastes can be found in numerous hospital settings such as lead shielding, x-ray film, and in silver and mercury containing materials. Waste paints, solvents, cleaning and laboratory materials can constitute RCRA hazardous waste. Solid and Universal Waste regulations can also apply. The proper identification, management and disposal of RCRA wastes present unique challenges in the hospital setting. hospital/medical/infectious waste incinerators (HMIWI), improper asbestos management, removal and disposal, or the presence of chlorofluorocarbons (CFCs). HMIWI are the predominant disposal mechanism for infectious wastes with an estimated 57 national medical incinerators burning approximately 146,000 tons of medical waste annually. This is down from a 1997 estimate of 2,400 medical incinerators burning approximately HMIWI are regulated under Sections 111 and 129 of the Clean Air Act. New medical waste incinerators are regulated in Kentucky by 401 KAR 59:023. There are a number of final or proposed regulations dealing with new and existing HMIWI that find THIS IS AN ADVERTISEMENT
implementation through 40 CFR Parts 60 and 62. They include New Source Performance Standards (NSPS) and Emission Guidelines (EG). State air implementation plan (SIP) issues, including Title V Permits, National Emission Standards for Hazardous Air Pollutants (NESHAPs), and Maximum Achievable Control Technology (MACT), may also apply to hospital facilities. Eleven years of litigation between environmental groups and EPA have greatly impacted regulation in this area. Clean Water Act compliance issues can involve direct wastewater discharge, wastewater pretreatment requirements and floor drains. Direct point source dischargers of wastewater are regulated by the “Hospital Point Source Category,” 40 CFR, Part 460. Indirect dischargers to Publicly Owned Treatment Works (POTWs) will be regulated by local pretreatment ordinances. Compliance with required Spill Prevention, Control and Countermeasure Plans (SPCC) to prevent the release of oil may also be required. Other issues requiring significant attention at hospitals may be the Toxic Substances Control Act (TSCA), the Safe Drinking Water Act, and the Emergency Planning and Community Right To Know Act (EPCRA). EPCRA deals with the identification and reporting of hazardous chemicals. This statute was a 1986 amendment to the Comprehensive Environmental Response Compensation and Liability Act (CERCLA) added as a result of the Bhopal, India, tragedy. It requires emergency planning, release notification, hazardous chemical inventory reporting, release reporting, and preparation of the Toxic Chemical Release Inventory (TRI). EPCRA integrates emergency planning with the Local Emergency Planning Committee (LEPC), the State Emergency Response Commission (SERC) and EPA Region IV. Violations commonly THIS IS AN ADVERTISEMENT
relate to failure to properly report the presence of hazardous chemicals and report Finally, there can also be issues involving potentially contaminated real estate. Many hospitals are located in the center of urban areas. The past uses of hospital property, including the presence of underground storage tanks (USTs), may impart liability to the current hospital owner. Kentucky’s Brownfields Program may be useful in EPA has developed an audit policy that can be of assistance to hospitals in the review of their environmental compliance. The policy, entitled, “Incentives for Self Policing: Discovery, Disclosure, Correction, and Prevention of Violations,” was originally promulgated in 1996 and was revised in 2000 (65 FR 19617). There are nine policy conditions which, if accomplished, entitle an institution in violation to report and seek the elimination or reduction of the gravity based component of a penalty. These components are systematic discovery, voluntary discovery, prompt disclosure, independent discovery and disclosure, correction and remediation, prevention of recurrence and cooperation. Certain violations and repeat violations are not eligible. EPA provides helpful materials to assist with audit practices. EPA Region IV, which is responsible for Kentucky, has received a number of hospital notifications under the audit policy, the vast majority from individual facilities. The statutes related to the disclosures were primarily EPCRA, followed by the Clean Air THIS IS AN ADVERTISEMENT
As our population increases and the sophistication of our health care grows, it becomes important to ensure that all environmental laws applicable to the unique waste


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