Mid-Atlantic Health Law TOPICS
Hazardous Waste Regulation and the Health Care Provider
Health care providers generate hazardous waste, and they face serious liability if they do not handle and dispose of that waste properly. Therefore, like it or not, it is important for health care providers to have a working knowledge of the statutory schemes that govern hazardous waste.
Hazardous waste is typically divided into two categories: listed hazardous waste includes waste generated by processes specifically listed in federal regulations, such as phenol from a pathology lab or silver waste from an x-ray facility; and characteristic hazardous waste which exhibits one or more hazardous properties such as used methanol (ignitable) or hydrochloric acid (corrosive).
Health care providers encounter hazardous waste regulation in two major contexts. First, the generation, storage and disposal of hazardous wastes are regulated "from the cradle to the grave" by the Resource Conservation and Recovery Act (RCRA). Under that Act, many commonly encountered waste materials, especially lab wastes, are subject to very stringent rules.
Second, a separate statutory scheme governs liability for contamination resulting from past waste disposal practices. That scheme is often referred to as "Superfund" and is governed by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). CERCLA can impose liability on facility owners and operators for disposal practices by prior occupants, for disposal practices that were entirely legal when undertaken, and even for environmental violations by the transporters or disposal contractors who accept the waste.
RCRA is the principal statutory scheme governing the generation, transportation, storage and disposal of hazardous wastes. The statute, and the extensive regulations promulgated pursuant to the statute, include extremely detailed requirements for every aspect of hazardous waste handling. A frequent source of confusion is that RCRA only governs waste materials. No matter how toxic, a material is not ordinarily governed by RCRA until it is no longer useful. For example, a container of arsenic is not subject to RCRA if a lab is storing it for possible use. Once the lab decides not to use the arsenic, it becomes a waste, and is immediately subject to RCRA.
RCRA rules differ depending upon the category into which the regulated company falls. "Generators" of hazardous waste are those who are in control of the hazardous material at the time it becomes a waste. "Transporters" are those who accept a waste from a generator, and then transport it to another destination. "TSDF" (treatment, storage and disposal facilities) are facilities licensed to accept waste from transporters or other third parties, and, as the name implies, treat, store or dispose of the waste. Health care providers, of course, will most often be concerned with the generator requirements.
Generators are subject to regulation if they create or accumulate 100 kilograms (about 221 pounds) of hazardous waste a month. Most hospitals and labs and many clinics will exceed that threshold. If subject to regulation, the generator must obtain a unique generator identification number from the Environmental Protection Agency. That number is used on the Uniform Hazardous Waste Manifest that must accompany each shipment of hazardous waste from the facility.
From a generator's standpoint, the manifest is the heart of the RCRA regulatory scheme for hazardous wastes. For example, the generator receives copies of the manifest back from the disposal facility as a means of assuring that the waste did, in fact, reach a licensed facility. Generators are required to maintain copies of these manifests and produce the copies during inspections. In addition, generators must make periodic waste reports to environmental agencies concerning the amount and types of manifested wastes shipped off site.
To assure that hazardous wastes are not allowed to accumulate at a generator's site, the wastes must ordinarily be shipped off site within 90 days. To assure that the deadline is met, generators must record the date when the waste was placed in storage. Most facilities meet these requirements by arranging for a licensed hazardous waste transporter to pick up wastes on a 60 or 90 day schedule.
Until picked up, the wastes must be carefully stored in locations that meet RCRA regulatory standards. Care should especially be taken to assure that incompatible wastes are not stored together, and that flammable wastes are not placed in dangerous locations.
Good management practices also dictate that facilities should undertake waste reduction efforts. There are often non-hazardous alternatives available, or ways to reduce the amount of hazardous waste generated.
CERCLA focuses on liability for past waste disposal. The first, and sometimes most difficult, issue for a non-environmental specialist to confront is that CERCLA liability is not based on the concept of fault. Instead, CERCLA holds a company or individual responsible for the remediation of contamination if that company or individual had any of several kinds of relationships to the contamination-even if the company or individual acted entirely within the law, and, in fact, followed all environmental guidelines and requirements.
For example, "Acme Hospital" might contract with a licensed, regulated transporter to pick up hazardous waste, and take it to a licensed disposal facility. If the transporter fraudulently mixes the material with other wastes, and then dumps it in a nearby ravine, the transporter is liable for the cleanup, but so is Acme. In fact, if the transporter and the other generators are bankrupt or cannot be located, Acme will have to pay the cost of cleaning up the entire site-even though not all of the wastes came from Acme.
The categories of "responsible persons" under CERCLA include the owner and operator of a facility where the material was generated or disposed, the generator of the material, and the transporter who selects the disposal site. All responsible persons who are financially viable must share the cost of any necessary cleanup.
An owner of a facility where hazardous substances were disposed is liable for the cleanup, even if the substances were released before the owner acquired the facility, unless the owner exercised environmental due diligence prior to acquiring the site. In practice, environmental due diligence means that the buyer performed a Phase I (and, if necessary, a Phase II) Environmental Assessment prior to the purchase, and no problems were discovered. Therefore such an assessment should always be performed before an operation or property is acquired, or a merger takes place.
Care should also be taken to assure that the assessment is carefully performed by a skilled professional. A sloppy assessment may shield the buyer from cleanup liability, but the buyer may still be left with property that is worthless because of undetected contamination. It is also recommended that the health care provider confirm that the consultant has adequate professional and liability insurance in case errors are made.
As is the case in many areas of health care regulation, an ounce of prevention is worth a pound of cure when it comes to hazardous waste handling and disposal. Understanding and adhering to applicable regulations can often save health care providers millions of dollars.
December 21, 2001