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EPA begins pilot program on medical waste management.

The Government this month begins testing a medical waste management program that will add millions to health provider costs yet guarantee only limited public safety improvements.

The program stems from last summer's panic over the medical waste washing up on East Coast beaches. Congress quickly responded to the headlines, ordering preparation of a two-year waste tracking demonstration project. The findings will likely influence whether additional, nationwide regulation is necessary. At press time, the Environmental Protection Agency (EPA) was set to implement the demonstration by late June.

Lawmakers originally designated three Eastem and seven Great Lakes states for the pilot program. The three Eastern states, New York, New Jersey, and Connecticut, will definitely take part. All the Great Lakes states except Michigan had opted to bow out of the program at press time. However, the District of Columbia, Rhode Island, and Louisiana petitioned for and received permission to participate.

The program targets waste "generators," transporters, and disposal facilities. Generators, including labs, hospitals, physician offices, clinics, and nursing homes, will be required to help track the disposal of waste products under threat of civil or criminal penalties. Exact requirements depend on the amount of waste generated, but most labs face the maximum of additional paperwork.

EPA regulations spell out seven types of medical waste to be monitored . They are:

*Human pathological wastes. These are defined as tissues, organs, body parts, or body fluids removed during surgery, autopsy, or other procedure, and specimens of body fluids in containers.

* Human blood and blood products. Beyond actual fluids, the list includes items saturated and/or dripping with blood, those that were saturated but are now caked with blood or its components, and their containers used or meant for use in patient care, testing, or lab analysis. Intravenous bags also fall into this category.

* Sharps used in human or animal treatment or in medical research or industrial labs. These include needies, syringes, pasteur pipettes, scalpel blades, blood vials, test tubes, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also: other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and coverslips.

* Contaminated animal carcasses or parts, and bedding known to have been exposed to infectious agents during research, production of biologicals, or pharmaceutical testing.

* Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions ftom persons who are isolated to protect others from highly communicable diseases. The same applies to materials from an

imals that are similarly infected.

*Discarded unused sharps. Regulators included these items as medical waste since both used and unused sharps present a public health hazard if they wash up on beaches. The category covers hypodermic needles, suture needles, syringes, and scalpel blades.

Under the EPA pilot program, generators of 50 or more pounds of such medical waste per month must complete a tracking form for each shipment headed for off-site treatment or disposal. Generators must complete the form according to instructions, then sign and date it by hand. They must also make certain the waste is properly segregated, packaged, and identified. Before releasing "custody" of the waste, facilities must obtain a signature and date of acceptance from the transporter on a copy of the form.

Large generators, which EPA notes will include most medical laboratories, should also receive a form back from the disposal facility within 35 days. Each facility would have to file an exception report with the regional EPA office and the state if it does not receive acknowledgement within 45 days of transport.

Smaller waste generators (less than 50 pounds per month) are exempt from the tracking form requirements, but they must keep logs of their shipments and adhere to the segregating, packaging, and labeling requirements.

Packaging requirements, which are expected to constitute the vast majority of generator compliance costs, generally state that waste headed for off-site disposal must be placed in rigid, leak-resistant containers. Packaging for needies, scalpels, and other sharps must also be puncture-resistant.

EPA made some compliance cost estimates for the program based on participation of all 10 states first targeted. And while officials haven't yet adjusted the aggregated estimate of $55.5 million, expenses on a per-facility basis still offer a reasonable measure.

The bottom line for labs: annual compliance costs of $1,255, about three-fourths of which is attributable to new packaging requirements. That compares with an estimated $3,757 a year for hospitals and about $70 for a physician's office . The cost for labs was based on agency estimates that such facilities generate an average of 250 pounds of waste a week and make 52 shipments a year.

Critics have already asserted that the true costs could be much higher, depending on how the categories of waste are interpreted.

They say, for example, that a dressing used for a cut in a doctor's office could be judged as "soaked" with blood, while the same amount of fluid on a hospital surgical sheet could be considered only "stained." Different interpretations would have a dramatic effect on the amount of waste that generators produce, critics note.

Ironically, even EPA officials question how well the demonstration project will address the original problem.

In an introduction to the 70page Federal Register notice of March 24, 1989, EPA states: "[These] regulations may not significantly reduce the amount of medical waste deposited on beaches. Sources of medical waste not addressed by the regulations (e.g., household medical care and intravenous drug use) contribute significantly to beach waste wash-ups. However, the regulations should insure that medical wastes from institutions and commercial sources are being managed properly."

Whatever the system's actual benefit, the risks for noncompliance are high. Generators whose records aren't up to par in EPA's eyes face civil penalties of up to $25,000 a day for each violation. Those who knowingly skirt the rules could be hit with criminal fines of up to $50,000 a day or as many as five years in prison.

The EPA project is destined for intense scrutiny by both Government officials and private-sector researchers.

The newest observer is the Medical Waste Policy Committee, administered by the Rockefeller Institute of Government at the State University of New York in Albany. Sponsoring members include a handful of major medical product suppliers, the American Hospital Association, the National Solid Waste Management Association, and the National Resources Defense Council.

A spokesman for the group explained that researchers are working on definitions of the medical waste problem, its scope, and current efforts of the Federal and state governments to correct it. An interim report is expected this month. The committee "hopes and expects to produce solutions to the problems that the public will find practical and effective and that public officials will find useful," the spokesman stated.
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Title Annotation:Environmental Protection Agency
Publication:Medical Laboratory Observer
Date:Jun 1, 1989
Previous Article:A question of professional ethics.
Next Article:Wellness testing: new opportunities for clinical labs.

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