A comprehensive biomedical waste survey.

The state of Oklahoma, as are all other states, is concerned about the production and management of biomedical waste (BMW). Although the predominant body of scientific literature supports the assertion that the real risk of acquiring an infectious disease through contact with BMW is extremely low, the general population perceives the risk of contracting a disease or illness from these materials to be extremely high (1). State government officials across the nation have responded to public concern by enacting legislation or promulgating regulations to manage the disposal of BMW.

The healthcare delivery system, environmental health practitioners, and the waste management authorities have also become much more sensitive to public concern. From a responsible public and environmental health perspective, it is critical that the response to perceived risk issues be with the same degree of professional concern and attention as any other public health matter. The public has every right to expect that BMW will be managed in an effective, safe, and responsible manner.

This article provides an overview of the development and current regulatory scheme for BMW disposal in Oklahoma and describes the progress toward an improved definition of the BMW stream in terms of sources, quality, quantity, and disposal practices.

The Regulation of Biomedical Waste

Waste disposal management was one of the first environmental health problems faced by man and remains one of the most burdensome. Although legal requirements for the management of solid waste have existed in the United States since before the turn of the century, the federal government has become directly involved only in the last few decades (2). When Congress passed comprehensive waste management legislation in the form of the Resource Conservation and Recovery Act (RCRA) in 1976, the definition of "hazardous waste" encompassed those wastes with infectious characteristics (3). Although a requirement to manage infectious waste was thus established legislatively, such waste was not effectively incorporated into the regulatory system which identified hazardous wastes and established the criteria for disposal practices.

During the 1980s, the public became increasingly alarmed about possible disease transmission due to BMW. Repeated incidents of medical waste washing onto the East and West Coasts and the shores of the Great Lakes, as well as reports of municipal sanitation workers being stuck with needles and then refusing to handle refuse suspected of being generated in the healthcare setting, fueled the escalating fear that HIV (human immunodeficiency virus) could be contracted from exposure to BMW.

Congress responded in 1988 by amending RCRA through the Medical Waste Tracking Act, which instituted a three-year demonstration project designed to support the development of a nationwide model for BMW management (4). The Medical Waste Tracking Act also required that the Agency for Toxic Substances and Disease Registry (ATSDR) study BMW in detail and submit, within two years, a report to Congress on the potential for infection or injury due to managing BMW; the degree to which sharps are implicated annually in the infection or injury of persons involved with BMW; those infected or injured annually by other means of medical waste management; and, for those diseases that may be spread by BMW, an estimate of the fraction of the incidence of those diseases that may be related to BMW.

ATSDR reported some 15 significant conclusions associated with BMW management, and an excellent overview of the ATSDR effort and conclusions is presented by Lichtveld, et al. (1). According to ATSDR, BMW comprises 0.3 % of the solid waste stream. Although the actual risk associated with the management of BMW is recognized to be low, opportunities for the public to interact with these wastes are increasing as in-home and hospice care grows more popular.

Some have charged that the federal government has been slow in acting to improve or enhance the framework for BMW management; however, it must be recognized that, due to the findings of ATSDR and the body of research developed pursuant to identifying the modes of transmission for HIV, BMW represents a low risk area for infectious disease transmission, especially outside the healthcare setting. Therefore, federal action has been slow. States, on the other hand, have recognized and addressed the more broad-based liability and good management practice aspects of BMW handling directly through legislative and regulatory efforts at the state level. A wide variety of state regulatory frameworks exists for BMW management and control, and these vary from the very restrictive to the very liberal. Some frameworks address the regulation of pretreatment, storage, and transportation, while others do not.

Oklahoma Program for Biomedical Waste Management

The definition of biomedical waste in Oklahoma is: ". . materials which are to be processed (discarded), and which are infectious wastes (such as those wastes capable of producing an infectious disease) which includes pathological wastes, biological tissues, soiled dressings, isolation wastes and other patient-care materials, contaminated sharps and other substances which have been in contact with pathogenic organisms and chemical wastes (such as pharmaceutical wastes, laboratory wastes, antineoplastic drugs and other chemicals). This definition should be construed to include any and all substances which contain materials or organisms which may cause injury or disease to man or his environment but which are not regulated as waste" (5).

In order for the state of Oklahoma to manage its BMW effectively, the quantity and types of biomedical wastes that were actually being generated and the current disposal practices had to be identified. In 1991, researchers at the Oklahoma Department of Environmental Quality (ODEQ) recognized the need for a comprehensive survey and analysis of the BMW production and management issues in the state. While designing the survey project, researchers also recognized that it was necessary to involve an objective third party to pursue the effort since many generators, transporters, and disposal facilities have an inherent resistance to providing regulators with information about a regulated waste stream.

In the summer of 1991, a contract was signed between the ODEQ and the University of Oklahoma Health Sciences Center for the Department of Occupational and Environmental Health to develop and conduct an anonymous statewide comprehensive BMW survey to ascertain generation rates, management techniques, major areas of concern, and overall disposal practices. The research team first identified the major categories of BMW generators in the state. These categories included hospitals, blood banks, county health departments, dentists, home healthcare services, Indian Health Service (IHS) clinics, morticians, nursing homes and extended care centers, physician offices and clinics, and veterinarians. To assist in identifying the categories of BMW generators, key professional organizations representing the previously mentioned service providers were contacted and the proposed project discussed. A vital portion of the effort was to gain the support and involvement of the professional organizations, both to reinforce the anonymity of the survey and to encourage participation in the comprehensive study.

It was considered imperative by the research team that any recommended changes to existing BMW regulations should be based on Oklahoma-specific information. In order to gain the highest degree of accuracy and participation in the data collection process, strict confidentiality was maintained for all participants in the study effort, and this confidentiality was emphasized by cover letters that were developed by all participating organizations and mailed with the survey instruments to each of the identified categorical generators in the state.

A total of 7,289 survey instruments, tailored for each category of generator, was distributed throughout the state, and returns in at least two categories were received from 75 of Oklahoma's 77 counties. A detailed listing of the survey distribution and return statistics is provided in Table 1.

Although the overall return rate of approximately 9% was less than desired, it was considered adequate to determine the state of management activities in Oklahoma since the best individual return rates were for the major generators of BMW. The return rates for hospitals of 68.67%, for IHS clinics of 50%, and for blood banks of 31.58% were considered extremely successful as they represented a comprehensive statewide response from both rural and urban generators. However, the 5.67% return rate for physicians, although based on 296 surveys returned from essentially every county in the state, was too low and could not be considered representative. Forty percent of responding physicians generated less than 10 pounds per day, and less than 1% of responding physicians generated over 50 pounds per day. For physicians' offices that operate an average of 20 days per month, the average of 4.8 pounds per facility per day results in a production rate of approximately 96 pounds per month.

Table 1. Survey Statistics.

                      Total Facilities   Surveys
Facility Category        Surveyed(*)     Received    Percentage

Blood Banks                   38            12         31.58
IHS(1) Clinics                22            11         50.00
Physicians                 5,221           296          5.67
Home Healthcare              156            16         10.26
Hospitals                    150           103         68.67
Nursing Homes                436            71         16.28
Funeral Homes                336            52         15.48
Veterinary Clinics           930            80          8.60
Total                      7,289           641          8.79

* Represents total number of facilities in category

1 Indian Health Service

Based on the survey responses, the research team estimated that approximately 1.6 million pounds of BMW are generated in the state of Oklahoma each month. Hospitals generate the largest amount of BMW per facility per day; home healthcare services and veterinary clinics generate the least. Together, hospitals and physicians' offices generate almost 90% of the BMW produced annually in Oklahoma. Table 2 lists BMW production, based on survey responses, by category of facility.

The transporters serving the categorical generators and disposal options were also identified. At the time this study was developed, 10 major transporters of BMW were identified. The term "major" is employed since a number of anecdotal reports were collected relating the existence of a submarket for BMW transportation via [TABULAR DATA FOR TABLE 2 OMITTED] unlicensed mechanisms. The primary licensed transporters were found to be carrying approximately 750,000 pounds of BMW per month. The survey did not address transportation of the remaining BMW.

Along with identifying sources of BMW production and transportation methods for off-site disposal, the research team collected data concerning the actual disposal practices employed by the generators. The team determined that approximately 40% of the BMW produced in the state was being incinerated at the single major Oklahoma-based BMW incinerator, which was receiving approximately 1.8 million pounds of BMW monthly from Oklahoma and other states. The remaining volume of BMW produced in Oklahoma, some 850,000 pounds per month, was mostly landfilled although some was sterilized or taken to specialized landfills. This point was of particular interest to the research team since it was determined that a number of the commercial and municipal landfills in the state were refusing BMW. Thus, many facilities were disguising their "red" bags so that the local collection and disposal process would not be interrupted or expensive alternatives to local disposal required.

Another point of interest and concern arose from the discovery that many healthcare facilities were paying for the disposal of a large volume of BMW that was not covered under the existing state of Oklahoma regulations for BMW management. Although some of the facilities recognized that what they were discarding was not by definition BMW, they chose to treat such materials as BMW, not to protect public health or the environment, but to reduce liability and to avoid legal exposure that might be associated with disposal. Many of the reporting institutions, however, stated genuine confusion as to exactly what constituted BMW, and when in doubt, they erred, without exception, on the side of caution.

Several important conclusions were reached by the research team relative to the importance of the data collected. First, for any survey of this nature to be successful, researchers must gain the support of the associated professional organizations in order to access the survey population more effectively. Second, a major survey effort of the type undertaken with this project must rely on candid and truthful responses from the surveyed facilities, and thus strict and binding confidentiality is a prerequisite. If the research team is viewed as a proxy enforcement agent of the regulator, candid information will be virtually impossible to obtain. Third, to gain the confidence and trust of the survey population, it is necessary to find methods to enhance personal contact and follow up on the survey process. The thrust of this effort was to gain an understanding of the actual management activities occurring in the state, not an accounting of who was "doing it right" and who was "doing it wrong." The desire was to obtain a snapshot of the actual activities conducted and the rationale for these actions; without access and trust, the results obtained would not have been possible.

The study resulted in a number of recommendations submitted to the ODEQ for consideration and action. Although the team submitted a total of 17 recommendations, the seven listed below represent the core group. (Interested readers are welcome to request a full copy of the recommendations, copies of the survey statistics, or copies of the actual survey instruments by directing inquiries to the corresponding author listed at the end of the article.) These predominant recommendations include:

1. Recognizing that the existing definition of BMW was too broad for simple application among the state's generator population, the team proposed that the definition be revised using as a model the definition that appeared in Section 102 of Senate Bill 2108 (Medical Waste Management Act of 1991). In addition, it was emphasized that the recently developed Occupational Health and Safety Administration Bloodborne Pathogen Rule should be consulted and incorporated into proposed changes at the state level.

2. The team proposed that the state move toward developing specific guidelines for "sharps" management. Sharps are the most common form of BMW produced and the single most common point of contact between the public and BMW. The research team received numerous complaints regarding the "improper" disposal of sharps from the public, healthcare delivery personnel, transporters, and disposal facilities, even though there were no specific guidelines at that time.

3. The team proposed that the state provide additional clarification to generators to enhance the level of understanding of exact requirements for BMW storage and transportation since the survey data revealed a widespread concern among the generators regarding their responsibilities for storage and transportation. The team recommended that each generator be required to develop a short, simple BMW Management Plan that would specify how wastes were to be managed on a case-specific basis. This document would serve to formalize performance among an industry that is already exceeding the level required by state regulations and to provide guidelines for on-site management of BMW. to prevent its achieving a putrescible state prior to collection and transportation for disposal.

4. The team recommended the formation of a BMW Task Force, comprised of the concerned members of the healthcare delivery organizations, transporters, and disposal facilities, to improve the dialogue between these parties and the regulators.

5. The team recommended that the Task Force, once formed, explore the issues related to establishing a small quantity generator of 25 kg of BMW per month, excluding sharps, as the basis for requiring a facility to develop the proposed BMW Management Plan, and that the approval of the BMW Management Plan result in the issuance of a permit to generate BMW. The permit would then serve as the mechanism to monitor the generator's performance under the terms of the BMW Management Plan.

6. The team recommended that persons engaged under the terms of the proposed BMW management plans receive appropriate basic and recurrent training for managing these wastes.

7. The team recommended that all efforts focusing on BMW management should be coordinated with broader solid waste management planning efforts since these wastes are an integral part of the municipal solid waste stream.

References

1. Lichtveld, M.Y., J.A. Lybarger, and S.E. Rodenbeck (1992), "The Findings of the Agency for the Toxic Substances and Disease Registry Medical Waste Tracking Act Report," Environmental Health Perspectives 98:243-250.

2. Bryson, N.S., R.C. Davis, B.G. Donohue, R.M. Hall, and R.E. Schwartz (1993), RCRA Hazardous Wastes Handbook 10th edition, Rockville, Md.: Government Institutes, Inc.

3. Resource Conservation and Recovery Act of 1976, [section] 1004 (5), as amended, codified at 42 U.S.C. [section]6903 (1988).

4. Medical Waste Tracking Act of 1988, Pub. L. No. 100-582, 42 U.S.C. [section]6992 et seq. (1988).

5. Oklahoma Administrative Rules 252:500-15-2 (1994).

Acknowledgements

The authors wish to express their sincere appreciation to the Oklahoma Department of Environmental Quality (ODEQ) for their foresight and support in planning and funding this important project. The authors also wish to acknowledge the project research team members; Marc W. Cogburn, M.S., Robert E. Davis, M.A., M.S., and Wendy J. Sours, M.S., and Regina L. White, MS., who assisted in the data collection and survey analysis. Also, the authors express their appreciation to Harriet Muzljakovich, Director of Solid Waste Enforcement, ODEQ, who served as the project officer for her efforts to effectively apply the survey findings in the continuing policy development process. The professional associations whose cooperation made this study possible were the Oklahoma Hospital Association, Oklahoma Medical Association, the Oklahoma Osteopathic Association, Oklahoma Nursing Home Association, Oklahoma Association for Home Care, Oklahoma Funeral Directors Association, Oklahoma Veterinary Medical Association, and the Indian Health Service, U.S. Public Health Service.

Dr. Daniel T. Boatright, Director, Institute for Environmental Management, College of Public Health, University of Oklahoma Health Sciences Center, P.O. Box 26901, Oklahoma City, OK 73190.