The medical waste outcry: a personal update.
A snapshot in time is offered by a participant in early efforts to identify stray medical waste on the Eastern seaboard.
On June 3 and 4, 1988, five blood tubes washed up on the New Jersey shore at Ortley Beach and Island Beach State Park in Ocean County. I was working as an AIDS researcher at the state health department in Trenton, overseeing Western blot antibody testing for HIV. The state health commissioner's office asked our group to examine the contents of those test tubes for antibody to the AIDS virus.
I remember speculating with my supervisor, Dennis Pontani, Ph.D., about the possibility that one of the test tubes might be found to contain HIV antibody. If so, we pondered the potential ramifications in light of the AIDS hysteria then sweeping the nation.
We thought that if the test tubes had originated at an STD clinic in Essex or Hudson counties, two of the highest areas of incidence in the United States, one of the tubes might very well be positive for HIV antibody. Indeed, two out of the five were positive for antibody to HIV via EIA and Western blot; one later tested positive for hepatitis B. We never did ascertain where everything had come from.
Wondering how the state commissioner's office would deal with these results, we handed in our findings on June 13. The next day, the acting commissioner of health, Thomas A. Burke, Ph.D., M.P.H., held a press conference and announced our findings. The main headline on the front page of the newspaper nearest the site, the Asbury Park Press, read: "AIDS link detected in beach vials."(1) The story, picked up by national wire services and television news, exploded across the country the same day.
In the Asbury Park Press article, noted AIDS researcher James Oleske, M.D., M.P.H., of the department of pediatrics and preventive medicine at the University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, calculated the potential threat to public health. Dr. Oleske was quoted as saying that "the vials could have posed a health threat--especially to children--if they were picked up and broken or stepped on." Also interviewed was Robert Dennis, a cofounder of the environmental group Save Our Shores (S.O.S.), who echoed Oleske's concerns.(1)
Although beach washups of medical waste had occurred the previous year, this was the first time such material had been tested for HIV antibody. Suddenly the connection was galvanized for the American public. Other examples followed.
* Beach bummers. On July 2-9, 1988, we tested 141 blood vials found in mud flats in Bayonne, N.J. Five were positive for antibody to HIV. During the same month, medical waste washed up in Connecticut, Massachusetts, New York, and Rhode Island. Markings on the tubes found in Massachusetts indicated that they had come from New York City.
By August, medical waste had been found as far south as Florida and in the Great Lakes. The drift of such waste had become a national campaign issue. Then--Presidential candidate George Bush addressed a crowd in Point Pleasant, N.J., while standing by the ocean. Wearing an S.O.S. sweatshirt and holding a bag of medical waste, he proclaimed that ocean dumping had to stop.
The situation became so devastating that people stopped swimming in the ocean, stopped eating locally caught seafood, stopped buying boats, and generally stopped vacationing at New Jersey beaches, where tourism had long been the primary industry. On July 26, five New Jersey beach towns announced their disconnection from the age-old expression "the Jersey shore." They were now to be referred to as the "Jersey Cape."
Direct economic costs to New York and New Jersey during the summer of 1988 were estimated at $1 billion to $5.4 billion.(2) Through the massive effort of many health care and other organizations, including police and fire departments, medical waste spillage was identified as a chronic regionwide problem. Several medical facilities, including so-called "Medicaid mills" and individual physicians' office labs, were found to have been dumping waste illegally. Other contributing factors included sewer overflow, storm water runoff, inadequate handling of solid waste at landfills and transfer stations, IV drug abusers' flushing of syringes down toilets, and various modes of disposal by legitimate users of syringes, such as diabetics.
As vice president of the New Jersey Public Health Association, I was asked on two nationally aired TV news shows in June 1989 to estimate the risk of contracting AIDS from medical waste that might wash up on the beaches during the summer to come. I replied, "None." I pointed out that the virus was too fragile to survive such a beating. I added that I hoped any hysteria lingering from the previous summer would have the positive result of inspiring people to demand that their beaches be cleaned up. I had seen medical waste on the beach for years when little or nothing was done about it.
* Legislation. The public appealed to state legislatures and Congress to pass strict laws dealing with medical waste. Partly as a result, Congress acted speedily, passing the Medical Waste Tracking Act in November 1988.
The act established a two-year demonstration program by which medical waste would be closely tracked from generation to proper disposal. For three states--Connecticut, New Jersey, and New York--participation was mandatory unless an equally or more stringent program was in place already (none were). Rhode Island and Puerto Rico volunteered to be included as well. States around the Great Lakes and others on the East Coast were invited to participate but declined.
The issue had by that time riveted national attention. In an address before a joint session of Congress on Feb. 9, 1989, President Bush stated, "The FBI and EPA will be instructed to prosecute illegal dumpers of medical waste, and new penalties against medical waste dumpers will be sought."
* Manifest destiny. On March 24, 1989, the Environmental Protection Agency issued rules establishing medical waste tracking requirements for states choosing to participate in the pilot program.(3) The cradle-to-grave manifest system established at that time requires the waste generator, transporter, and disposal facility to use a four-part tracking manifest form that follows the waste to its intended destination. The system was modeled on the tracking system that has been used successfully for many years to prevent illegal disposal of hazardous waste.
The clinical laboratory or other generator of the waste initiates the form and retains copy 4. The other three parts accompany the transporter carrying the waste. Upon delivering the waste, the transporter signs the manifest, retains copy 3, and leaves the remaining two parts with the disposal facility. An official at that facility verifies that the medical waste has been received, retains copy 2, and sends the original manifest, copy 1, back to the generator; it must arrive within 35 days. If not, the generator contacts the transporter and disposal facility to determine what happened to the waste. After 10 more days, the generator must notify EPA and the appropriate department of the state government.
Other sections of the Medical Waste Tracking Act cover the segregation, packaging, labeling, marking, and storage of medical waste. Failure to follow the provisions of the act may incur civil penalties of up to $25,000 per day for each violation and criminal penalties of up to $50,000 per day per violation. In addition, a representative of management--the chief executive officer, officers of a laboratory, or a person directly in charge of disposal, for example--can be imprisoned for up to five years. So far, defying the act has not sent anyone to jail. One sentencing was pending at press time, however.
* Nailing an offender. On Jan. 31, 1991, a Federal jury found the vice president of a Brooklyn, N.Y., medical lab guilty of having illegally dumped vials of blood in waters off New Jersey and Staten Island in 1988. Some of the vials, traced to the lab through their identification numbers, were contaminated with hepatitis B virus. The lab executive faces a maximum jail sentence of 36 years and a fine of up to $1 million.(4) Charges against the company were dropped after it went out of business. According to the New York Times, this was the first conviction related to the 1988 dumping of medical cal waste into New York metropolitan area waters.(5)
* Other regs. Health care facilities such as hospitals, clinics, laboratories, and physicians' and dentists' offices produce a wide range of waste streams, of which infectious waste is a small subset. Under the Medical Waste Tracking Act of 1988, the EPA specifically regulates cultures and stocks of infectious agents; human blood and blood products; human pathologic wastes, including those from surgery and autopsy; contaminated animal carcasses from medical research; wastes from patients with highly communicable diseases; all used sharps, such as needles and scalpels; and certain unused sharps.
This two-year demonstration program will expire June 22 of this year. Congress will then have to decide whether to take permanent action.
* Legislative variations. The EPA definition of medical waste is used only by the four states and one U.S. territory that participated in the original Federal demonstration program. A major problem in formulating regulations is that medical waste remains poorly defined. A study team from the Nelson A. Rockefeller Institute of Government in Albany, N.Y., reported in June 1989: "No standard, uniform definition [of medical waste] exists and there seem to be as many definitions in use as there are government agencies and other groups concerned with medical waste. Since the definition adopted by a regulatory agency determines which wastes must receive special treatment, it has serious implications . . . [such as] increased costs to health care providers and waste handlers."(6)
Under current New Jersey and EPA regulations, for example, disposable gloves used in a clinical laboratory are not considered regulated medical waste unless they are saturated or dripping with human blood--a condition that doesn't hold true in New York State. The Rockefeller Institute report continues: "The failure to agree on a national definition of medical waste has led to a great deal of confusion. Narrow definitions include perhaps 5% of hospital waste whereas the broadest definitions may involve as much as 70% to 90% of hospital waste. The economic effects of this variation can be substantial."
Other substantial differences are observed in medical waste regulations from state to state. New York and the EPA, for example, permit exemptions for small-quantity generators of less than 50 pounds of medical waste per month. New Jersey, on the other hand, requires all medical waste generators, including physicians who may dispose of two needles per month, to register with the state and comply with the regulations. New Jersey offers a bounty of 10% of the fine, to a maximum of $250, for any citizen who turns in an illegal dumper of medical waste. Some states still have no program in place, although most are developing them.
Labs in New York City and elsewhere must comply with three sets of regulations on medical waste disposal: local, state, and Federal. Even when all three sets of rules are similar, they may vary enough to create confusion and raise the cost of compliance.
Discrepant regs may require judgment calls over conflicting nomenclature. An example: As the Greater New York Hospital Association has noted, "Trying to discriminate between |blood soaked,' |blood stained,' and |blood tinged' can only result in massive oversorting in favor of |blood soaked' to ensure compliance and avoid penalties."(7) Definitions that reflect a single national focus are badly needed.
In a report issued on Feb. 23 of this year, the Office of Technology Assessment stated that Congress could eliminate "much of the confusion and inconsistency associated with medical waste policy" by designating an agency "to coordinate and clarify the Federal Government position on medical waste issues," according to a New York Times article. "Applying a more comprehensive waste management approach to medical wastes, such as has evolved for municipal solid waste and hazardous waste," OTA continued, "could help insure environmentally sound and economically feasible waste practices."(8)
* Public health risks. Another area of intense debate involves the health risks posed by medical waste during disposal. In a recent report to Congress, the Agency for Toxic Substances and Disease Registry (ATSDR) concluded that risk to public health is extremely low. The report predicts that the handling of medical waste might result in one to four cases of AIDS (not HIV infections) per year and up to 321 hepatitis B infections, caused by injury from sharps. Such injuries, according to the report, are most likely to occur within the health care setting before the material is transported off site.(9)
The report cites an estimated 1.3 million illicit drug users, among whom rates of HIV and HBV infection are typically high, as a significant source of discarded sharps. By failing to discard sharps properly, this population increases the public's risk of contact with infected sharps.
In a recent survey, medical waste industry workers in Washington State were found to experience substantial exposure to blood and body fluids. Blood on clothing was reported by 22%, on the skin by 8%, and on the face or eyes by 3%. Only 26% said they had been trained to avoid the hazards associated with medical waste. Fully half (50%) reported having received cuts and scratches on the job.(10)
* Treatment of waste. In the past, most medical waste was placed in red bags and sent to landfills--untreated. Highly infectious material from microbiology departments tended to be autoclaved before transport. Some large facilities maintained on-site incinerators for processing waste.
Changes have been marked during the last three years. Many areas, including New Jersey, demand that regulated medical waste be rendered not only noninfectious but also unrecognizable as medical waste before disposal; in other words, it must be destroyed. No longer is it acceptable merely to autoclave it. The waste must then be manifested to its final destination, as discussed above.
Traditional disposal methods for medical waste have begun to disappear. The use of landfills in particular is becoming a less available option because of the strict pretreatment requirements dictated by most states. Increasingly as well, landfill operators are refusing to accept recognizable medical waste.
Then--Governor Thomas Kean appointed me to the New Jersey Solid Waste Advisory Council in 1988 as an expert on AIDS and biosafety. My role was to deal with issues involving medical waste.
Part of the charge of the council is to study and investigate the technical capabilities available and the limitations of regulations concerning medical waste. We regularly report our findings to the commissioner of the state department of environmental protection. Last year we examined new technologies for medical waste destruction and held a public hearing on disposal.
* Incineration. Most state and Federal agencies recommend incineration for disposal of medical waste. A report presented at the annual Air and Waste Management Association Meeting in June 1989 stated: "Recent air quality analyses have demonstrated that dual-chamber medical waste incinerators equipped with the best available control technology (BACT) are not major sources of emissions and are capable of destroying all pathogens."(11)
Nevertheless, environmental activist groups, especially in the Northeast, have concentrated their scrutiny on incineration. Such groups question the long-term public health effects of incineration on people who live near incinerators. Among their concerns are ground-level concentrations, cavity effects, and center-line plume impacts. Protesters in this vein, popularly called NIMBYs--that is, environmentalists who cry, "Not in my back yard!"--represent a formidable force for laboratory professionals and others who are attempting to obtain a new incinerator or upgrade an old one.
Frustrated yet impelled to re-think their medical waste disposal protocols, many hospitals have incinerated waste in preexisting outdated incinerators not designed to handle that waste stream. This issue was noted by Allen Hershkowitz, who served on the peer review panel for the first medical waste report to Congress by the Office of Technology Assessment. "The real danger, which has received far less notice, stems from the 6,000 substandard medical waste incinerators around the nation," he wrote in a journal article. "Usually concentrated in urban populous areas, these facilities each year spew tons of toxic emissions, including dioxin, heavy metals, and acid gases, into the air at much higher rates than state-of-the-art incinerators."(12) Indeed, a draft of the OTA report to Congress states that air emissions of dioxin and heavy metals from hospital incinerators are 10 to 100 times greater per gram of waste than those produced by state-of-the-art municipal waste incinerators.(13)
Late last year, the New York Times commented on the same issue. "In the past, many hospitals operated small incinerators on their own property to destroy bacterially contaminated material," the article stated. "But tighter rules on emissions in highly populated areas have shut down many of these operations, which often had only primitive pollution control equipment. In New York State, according to the National Solid Waste Management Association, none of the hospital-owned incinerators now operating can meet the state's 1992 air quality standard."(14)
Alternative technologies to incineration are being developed. Four are discussed in "Developing technologies for medical waste disposal."
* Trends. I recently interviewed Robert Confer, chief of the Bureau of Special Waste Planning for the New Jersey State Department of Environmental Protection and a major player in the evolution of medical waste legislation. Confer described some of the innovations conceived for encouraging compliance with state regulations by the health care industry. To make it easier to collate information from various annual reports about generators, for example, the bureau now translates each report into a format that is scanned by a computer and collated for quick analysis of data.
Asked how he planned to monitor compliance with the new regulations, Confer said that his team of inspectors during the first year intended to educate the medical community. In general, he said, institutions that demonstrated a conscientious attempt to comply would not be fined. Blatant disregard of the regulations, however, would lead to fines and penalties.
According to Confer, 50% to 60% of notices of violations have cited only minor technical violations in segregation or packaging. Of the rest, however, 10% to 15% had failed to register, a far more serious offense. Larger institutions tended to have better compliance records than smaller facilities, he said.
No new disposal technologies have been officially approved or sanctioned by the State of New Jersey, Confer said. The state will register and issue permits for any reputable device that destroys and treats medical waste. His office awaits recommendations from an upcoming EPA report on the efficacy of various treatment methods that will probably be available this summer or fall.
* Personal thoughts. A uniform national standard for defining and handling medical waste is desperately needed. A tremendous amount of needless duplication and confusion is now taking place that a general standard would eliminate. Labs are already dealing with so many levels of regulation that they deserve a little assistance and simplification of procedures.
Despite ongoing problems, I believe the beaches of the New Jersey coastline were cleaner and safer in the summer of 1990 than during the two previous summers. I sense a greater general respect for the need to assure the safety of those handling medical waste and growing concern about disposal methods. Developments to date represent only the beginning.
As has happened so many times before, it took a clear and present danger to frighten health care officials into recognizing the enormous task before them. The health care community, including clinical labs across the nation, will participate heavily in the tremendous amount of work that remains to be done. The goal--the probable eventual result--will be a safer workplace and better-preserved environment for health care workers and the public they serve everywhere.
PHOTO : Medical waste on New York metropolitan beaches in the summer of 1988 prompted national protest. The author photographed the detritus above.
PHOTO : When rendered noninfectious and unrecognizable, medical waste may be handled as household trash. (1)Johnson, J. "AIDS link detected in beach vials." Asbury Park Press, p. A1, col. 2, June 16, 1988. (2)Kahn, J.; Ofiara, D.; and McCay, B. "Economic Measures of Beach Closures: Use Impairments and Ecosystem Impacts of the New York Bight." Report prepared by the Waste Management Institute, MSRC, State University of New York at Stony Brook, for the Dynamac Corporation as part of EPA's New York Bight Restoration Plan. Stony Brook, N.Y., 1989. (3)U.S. Environmental Protection Agency. "Standards for the tracking and management of medical waste," in Code of Federal Regulations, 40 CFR, Parts 22 and 259. Washington, D.C., March 24, 1989. (4)New York executive found guilty of illegally dumping medical waste. Infectious Wastes News 6(3): 2, Feb. 4, 1991. (5)Lab official guilty in medical-waste case. The New York Times, p. A31, Feb. 3, 1991. (6)Stewart, T.S.; Mumpower, J.L.; De Alteriis, M.; et al. Issues in medical waste, in "Perspective on Medical Waste: A Report of the Nelson A. Rockefeller Institute of Government." Albany, N.Y., Nelson A. Rockefeller Institute of Government, June 1989. (7)Greater New York Hospital Association. "Resource Conservation and Recovery Act Docket." Docket No. F-89-MTPF-FFFFF, May 19, 1989. (8)Congressional report urges U.S. to set a policy on medical waste. The New York Times, p. A24, Feb. 24, 1991. (9)U.S. Department of Health and Human Services, Agency for Toxic Substance and Disease Registry. "The Public Health Implications of Medical Waste: A Report to Congress." Washington, D.C., 1990. (10)Turnberg, W.L., and Frost, F. Survey of occupational exposure of waste industry workers to infectious waste in Washington State. Am. J. Public Health 80(10): 1262-1264, 1990. (11)Konheim, C.S., and Reiss, N.M. "Environmental Consequences of Alternative Methods of Incinerating Medical Wastes." Presented at the 82nd annual meeting of the Air and Waste Management Association, Anaheim, Calif., June 1989. (12)Hershkowitz, A. Without a trace: Handling medical waste safely. Technol. Rev. 93(6): 35-40, August/September 1990. (13)Congress of the United States, Office of Technology Assessment. "Finding the Rx for Managing Medical Wastes: OTA Special Report on Medical Waste Treatment Methods" (draft report). Washington, D.C., June 4, 1990. (14)Holusha, J. Medical waste: New technology. The New York Times, p. C2, Nov. 20, 1990.
James W. Brown, Ph.D., M.H.A. The author is director of microbiology and of health and environmental affairs at Roche Biomedical Laboratories, Raritan, N.J.