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EPA's next enforcement target: healthcare facilities and the lab.

Just when laboratory teams conquered the latest accreditation standards, the Environmental Protection Agency (EPA) turned a regulatory eye toward healthcare facilities and has already levied substantial fines for non-compliance. EPA once targeted "heavy" industries (i.e., manufacturing) for compliance auditing, but now its healthcare-facility compliance initiative places the clinical and pathology laboratories' hazardous-waste-management practices in the spotlight.

The move towards compliance

Moving healthcare towards environmental compliance began in 1998 when the EPA and American Hospital Association (AHA) signed a memorandum of understanding urging healthcare facilities to voluntarily reduce both waste-stream volume and toxicity. Goals included virtually eliminating mercury by 2005; reducing overall solid- and hazardous-waste volume; and minimizing use of persistent, bioaccumulative, and toxic (PBT) chemicals, designated as those which persist in the environment for an extended time, then accumulate and achieve toxicity levels harmful to humans and the ecosystem.

Significant progress was made toward these goals. Educating the healthcare industry about hazardous-waste generation led to the Hospitals for a Healthy Environment program (H2E) whose current best practices and compliance-assistance resources are available at Education remains an important part of the EPA and AHA agreement but has had fairly limited impact on healthcare facilities meeting EPA's complex hazardous-waste-management standards. That is, until 2002 when EPA Region 2, that oversees New Jersey, New York, Puerto Rico, and the Virgin Islands, began its healthcare-facility compliance enforcement (inspections) and notified area facilities they were in the EPA's sights. (1) Since then, Region 2 alone imposed over $1 million in fines as a result of audit findings. (2) Success of EPA's Region 2 healthcare compliance initiative is being emulated by EPA Region 1 and Region 3, covering the New England and Mid-Atlantic states, respectively. (To locate a particular EPA region, visit

According to recently published EPA enforcement data, 66% of healthcare facilities were audited nationwide between 1998 and 2004, bringing the healthcare industry in better alignment with other business sectors. (2) Additionally, a number of state/regional environmental agencies--including California, Minnesota, Hawaii, and the Northeast--recently targeted healthcare-facility compliance. It is important to note that states and local authorities often have stricter environmental-protection regulations than the EPA. (3) More information on individual state's regulations can be found at

From cradle to grave

The EPA governs hazardous wastes under the Resource Conservation and Recovery Act (RCRA) Subtitle C--Managing Hazardous Waste regulations. (More information on the RCRA can be found at These comprehensive regulations make the waste generator responsible for proper management from cradle to grave--that is, from the moment of generation, through transportation, storage, and treatment, until final disposal. Clinical- and pathology-laboratory chemical wastes are among the healthcare waste streams heavily cited by the EPA for non-compliance under these regulations. Hazardous-waste-management activities are supported with documentation, including the hazardous-waste manifest, providing the paper trail for wastes transported from a lab facility through disposal. Documentation must be kept on file for at least three years. Revised hazardous-waste manifest forms will go into effect on Sept. 5, 2006. Until that time, existing forms must be used. For details on the revised forms, go to

Identifying hazardous waste

Hazardous-waste identification is critical to the cradle-to-grave system. If performed incorrectly, hazardous waste may be treated or disposed of improperly. There are many hazardous wastes; these may be liquids, solids, or contained gases. EPA specifically "listed" more than 400 different wastes, designated as P-, U-, F-, and K-listed. (K-listed wastes are not applicable to healthcare). Clinical and pathology laboratories typically produce a variety of listed and characteristic hazardous wastes. (2) Numerous hazardous wastes are designated as "characteristic" when they meet one or more of the following conditions.

* Ignitability: can create fires under certain conditions, are spontaneously combustible, or have a flash point of less than 60[degrees]C.

* Toxicity: harmful or fatal when ingested or absorbed, or may leach from waste and pollute ground water.

* Corrosivity: acids or bases that are capable of corroding metal containers.

* Reactivity: unstable under normal conditions, and can cause explosions, toxic fumes, gases, or vapors when heated, compressed, or mixed with water.

Determining waste-generator status

To comply with EPA hazardous-waste regulations, it is imperative that healthcare facilities identify their hazardous wastes accurately and count all hazardous waste generated monthly. This information is the basis for classifying the facility's waste-generator status, which ultimately determines the EPA generator requirements including on-site storage quantity and time limits, record keeping, reporting, and so forth. RCRA regulations impose more stringent rules as waste quantity increases. The EPA designates three tiers of generators from smallest to largest quantity, as follows:

* conditionally exempt, small-quantity generator or CESQG;

* small-quantity generator or SQG,

* large-quantity generator or LQG.

Clinical and pathology laboratories must prepare now for the genuine possibility of an impending environmental-compliance audit. Although the EPA's regulations governing chemical-waste management are complex, laboratorians need to learn about proper waste identification and comply with applicable waste-generator responsibilities, such as the revised uniform hazardous waste manifest rules effective Sept. 5, 2006.



(1.) U.S. Environmental Protection Agency (2006). Region 2 multiyear healthcare initiative. The CA Compass, Vol 2. Available at Accessed May 30, 2006.

(2.) Profile of the Healthcare Industry. Office of Compliance, Office of Enforcement and Compliance Assurance, U.S. Environmental Protection Agency, 2005. Available at Accessed May 30, 2006.

(3.) Hotaling, M. The EPA is Coming: What you need to know now about hazardous waste management. Clinical Leadership & Management Review. September/October 2006. 20(5).

By Mary Hotaling, MS, MT(ASCP)DLM

Mary Hotaling, MS, MT(ASCP) DLM--a clinical assistant professor at the Health Sciences Center of Stony Brook University in Stony Brook, NY--is a healthcare management consultant and laboratory safety officer for Good Samaritan Hospital Medical Center in West Islip, NY.
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Title Annotation:Washington report
Author:Hotaling, Mary
Publication:Medical Laboratory Observer
Geographic Code:1USA
Date:Jul 1, 2006
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