Defining and managing biohazardous waste in U.S. research-oriented universities: a survey of environmental health and safety professionals. (Features).

Introduction

"Biohazardous waste" is an umbrella term for waste that poses a biological hazard to living organisms. It encompasses medical waste, which primarily comprises wastes potentially infectious to humans, as well as wastes from animal or plant research that are potentially infectious to those organisms or might alter their natural genetic-selection process. Research that generates biohazardous waste is commonly conducted at large research-oriented universities.

Management of the biohazardous waste stream in this environment is a challenge to the environmental health and safety (EHS) professional, who must consider multiple state and federal regulations and accreditation requirements (Table 1). The EHS professional also must understand the nature of research being conducted.

The purpose of this study was to identify how large research-oriented universities address biohazardous waste management by surveying EHS professionals responsible for this activity. EHS professionals at such institutions were asked the following questions:

1. Which agency regulations or guidelines (state, federal, accreditation) are used to define biohazardous waste streams?

2. What are the most common methods of treatment and disposal for various categories of biohazardous waste produced?

3. What administrative controls are used to ensure safe and proper handling, treatment, and disposal of biohazardous waste? Results are provided, along with recommendations for developing an effective model biohazardous waste management plan for large research-oriented universities.

Methods

The sample population in this study was universities that are classified by the Carnegie Foundation for the Advancement of Teaching as Research I and Research II universities (Higher Education Publications, Inc., 1999). In 1999, Research I universities were defined as giving high priority to research and receiving $40 million or more annually in federal funding. There were 88 universities that fit this classification. Research II universities also were defined as giving high priority to research, but as receiving between $15.5 million and $40 million annually in federal funding. There were 34 Research II universities, making a total sample population of 122. Research I and Research II universities were chosen for this study because they are most likely to conduct research in areas such as microbiology, biochemistry, and animal science, in which medical or biohazardous waste is generated outside of a clinical environment. In addition, these universities are likely to have an EHS staff that is knowledgeable abo ut, and possibly responsible for, the administration of the university's program for managing biohazardous waste.

The EHS department of each university was contacted by phone to identify the appropriate person to complete the survey. Once identified, potential respondents were contacted by phone 1) to verify that each of them was the best person to complete the survey, 2) to provide an overview of the survey and its significance, and 3) to verify mailing information.

A questionnaire was sent by mail and served as the survey instrument for this study. To ensure that questions were clear and appropriate, the survey was pilot-tested by a group of EHS professionals who were not part of the respondent group. The pilot group comprised individuals who were active in the administration of their institution's biohazardous waste management program but not directly responsible for it.

The final questionnaire contained 17 questions, closed-ended and exhaustive, based on the research questions previously stated. Respondents were asked to return their completed survey within 30 days. After the 30-day period, nonresponders were contacted by email or by phone and reminded of the survey Data collection was terminated after 90 days, with a final response rate of 82.6 percent.

Results

Institutional Profile

Information is given in Figure 1 about the kinds of activities or facilities at each institution that would be likely to affect the generation of biohazardous waste. Forty-three percent of respondents indicated that their institution had an in-patient health care facility. Thirty-four percent indicated that their institution had a veterinary-medicine school that engaged in teaching, treatment, and research. All respondents (100 percent) indicated that biotechnology research (defined as recombinant DNA, gene therapy, or transgenic work) was conducted at their institution. Ninety-seven percent of respondents indicated that research classified as Biosafety Level 2 (BL-2) was being conducted at their institution, while 60 percent indicated that their institution had facilities suitable for BL-3 research. Biosafety levels are defined in Biosafety in Microbiological and Biomedical Laboratories Guidelines (Centers for Disease Control and Prevention [CDC] & National Institutes of Health [NIH], 1999). They pertain to the combination of laboratory practices and techniques, safety equipment (primary barriers), and facility design (secondary barriers) that is warranted to minimize risk to laboratory personnel and the environment from infectious agents being used in research. There are four biosafety levels (BL-1 through BL-4), with BL-2 being the minimum level for agents that are potentially infectious to humans. CDC/NIH's procedural and facility requirements increase as the biosafety level increases.

Development of and Responsibility for Biohazardous Waste Management Procedure

As shown in Figure 2, EHS personnel were asked what regulations or guidelines were used to develop biohazardous waste management policies. Percentages for each category were based on the total number of respondents for the category Sixty-three percent of respondents indicated that U.S. EPA regulations (i.e., the Medical Waste Tracking Act [MWTA] [1989]) had been used as a basis for their policies. Sixty-four percent indicated that local regulations were used, while 98 percent indicated that state regulations were used. Occupational Safety and Health Administration (OSHA) regulations were cited by 93 percent of respondents. Eighty-six percent of respondents indicated that CDC/NIH guidelines were used in the development of policies. Forty-nine percent indicated that U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) requirements were used (Introduction of Organisms, 1997). The requirements of accreditation agencies were cited by 61 percent of respondents, and U.S. Departmen t of Transportation (U.S. DOT) requirements were cited by 69 percent of respondents. Five respondents listed other regulatory requirements, including state agricultural regulations, state health codes, and Nuclear Regulatory Commission requirements.

The biosafety officer was the individual most frequently designated (at 40 percent of the institutions surveyed) as responsible for policy development and implementation. A biosafety committee was the responsible body at 12 percent of the institutions. Nineteen percent of respondents indicated that the hazardous waste specialist was the individual responsible for development of biohazardous waste policy. Twenty-nine percent of respondents indicated that "others" were responsible or that safety committees and EHS professionals had "joint responsibility" at their institutions.

Defining Biohazardous Waste: Highlight on Cell Cultures and Sharps

Respondents were asked how their universities defined biohazardous waste. As shown in Figure 3, 98 percent of respondents indicated that human cell cultures regarded or known to be infectious are treated as biohazardous waste. Non-infectious human cultures also were regarded as biohazardous by 84 percent of respondents. For animal cell cultures, 91 percent of respondents indicated that the items are treated as biohazardous waste if known to be infectious, and 65 percent indicated that non-infectious animal cell cultures also are treated as biohazardous waste.

For plant cell cultures, 76 percent of respondents indicated that the items were treated as biohazardous waste, and 42 percent indicated that non-infectious plant cell cultures also were regarded as biohazardous waste.

As shown in Figure 4, 85 percent of respondents indicated that all hypodermic needles and syringes with needles are managed as biohazardous sharps by their institutions regardless of contamination status. All syringes without needles were treated as biohazardous sharps by 54 percent of institutions. All scalpels and razor blades were managed as biohazardous sharps by 72 percent of institutions.

Twenty-five percent of institutions indicated that all glass specimen tubes were managed as biohazardous sharps regardless of contamination status. All Pasteur pipettes were managed as biohazardous sharps by 35 percent of institutions. All capillary tubes were treated as biohazardous sharps by 28 percent of institutions. Twenty-six percent of respondents indicated that all slides and cover slips were managed as biohazardous sharps. Fifteen percent of institutions indicated that broken glass, regardless of contamination, was treated as biohazardous sharp material.

If a respondent did not indicate that an item was treated unconditionally as a sharp, responses regarding the specific conditions under which an item would be managed as a biohazardous sharp were tallied. As shown in Figure 5, a common trend was observed in the treatment of all categories of sharp items on the basis of type of contamination, in general, the greater the infection risk to humans, the more likely an item was to be managed as a biohazardous sharp. Ninety-three percent of respondents indicated that sharp items were treated as biohazardous waste if they were contaminated with human blood. Likewise, 95 percent treated sharp items as biohazardous waste if the items were contaminated with material infectious to humans. Sixty-six percent of respondents indicated that sharp items contaminated with animal blood also were managed as biohazardous sharps. Sharp items contaminated with material infectious to animals were managed as biohazardous sharps by 79 percent of the respondents. Sharps contaminated wit h material infectious to plants were treated as biohazardous sharps by only 56 percent of the respondents. Finally, 26 percent of respondents indicated that radioactively or chemically contaminated sharp materials were managed as biohazardous waste.

Off-Site Biohazardous Waste Treatment Methods

The portion of biohazardous waste that was managed off site was assessed. Eighty-seven percent of respondents indicated that some portion of their university's biohazardous waste was treated and disposed of through a licensed medical waste hauler. Specifically, 13 percent used a medical-waste hauler (MWH) for between 1 percent and 10 percent of their biohazardous waste, 10 percent used an MWH for between 11 percent and 25 percent of their biohazardous waste, 10 percent used an MWH for between 26 percent and 50 percent of their biohazardous waste, 8 percent used an MWH for between 51 percent and 75 percent of their biohazardous waste, and the remaining 46 percent used an MWH for 75 percent of their biohazardous waste.

On-Site Biohazardous Waste Treatment Methods: Autoclaves and Incineration 

Ninety percent of the respondents indicated that autoclaves were used for biohazardous waste treatment at their institutions.

Respondents also were asked to indicate the various means by which waste was disposed of once treated by autoclave. Of those indicating use of autoclaves,

* 75 percent indicated that autoclaved waste was sent to landfills as nonhazardous waste;

* 44 percent indicated that autoclaved waste was incinerated

* 16 percent indicated "other" options, with write-in responses including further management through an MWH and shredding.

With respect to validation of autoclaves as an effective means of waste decontamination, 52 percent indicated that the autoclaves were periodically tested with a biological indicator. Approaches to validation named by respondents not using a biological indicator ranged from no formal procedure for validation through testing with chemical indicators at various frequencies.

Information also was collected on the use of on-site incineration as a waste treatment and disposal method. Forty-two respondents indicated that they had an on-site incinerator used for treatment and disposal of biohazardous waste. Of those, 22 indicated that their incinerators were classified as hazardous-medical/infectious-waste incinerators (HMIWI) as defined by recent U.s. EPA regulations (Medical Waste Incinerators Final Rule, 1997). Of the 22 respondents affected by U.S. EPAs HMIWI regulations, nine indicated that their current equipment and management systems would meet the more stringent requirements, one indicated that the institution's equipment would be upgraded to meet regulatory requirements, three indicated that their institution would discontinue incineration, eight indicated that use of incineration in the future had yet to be determined, and one did not complete this portion of the question series.

Biohazardous Waste Management Program Compliance: What's Effective?

As shown in Table 2, the control provisions identified by EHS staff as most critical to the success of biohazardous waste management programs were training requirements for waste generators (30 percent), segregation and packaging requirements (26 percent), and inspections (23 percent). Manifesting or tracking of waste was indicated as a critical provision by 10 percent of respondents. Emergency contact information (1 percent), contingency plans for disposal (1 percent), and additional training requirements for those who treat their own waste (2 percent) were the control provisions rated lowest. Seven percent of respondents indicated "other" control provisions as critical, including withholding approval to conduct research.

Discussion

The results of this study provide important information on biohazardous waste management in the large-research-oriented-university environment. All participating universities were conducting biotechnology and BL-2 research, while fewer than half had an inpatient health care facility. Results indicated that biohazardous waste management teams in large research-oriented universities do not rely solely on policies and regulations addressing only medical waste; the most frequently cited guidelines used to develop management plans were state regulations, the OSHA Bloodborne Pathogens (BBP) Standard, and CDC/NIH guidelines.

Interesting data were gathered on treatment and disposal of cell cultures, Human cell lines are considered to be potentially infectious materials by OSHAs Bloodborne Pathogens Standard unless they are tested and determined to be virus-free (OSHA, 1994). While 93 percent of respondents indicated that they based their biohazardous waste management plans on OSHA BBP requirements, only 84 percent of respondents treated all human cell cultures as biohazardous waste. The difference suggests that 9 percent of respondents either are testing their cell lines to ensure that they are virus-free or are not managing these items properly for disposal,

Regarding the management of sharps as biohazardous waste, three items were consistently managed as biohazardous waste regardless of their contamination status: hypodermic needles (85 percent), syringes with needles (85 percent), and scalpels/blades (72 percent). By design, these items present a puncture hazard and are identified as sharps under OSHAs BBP Standard if they are biologically contaminated (Bloodhorne Pathogens Standard, 1990). Syringes with needles and hypodermic needles also are commonly associated with mismanagement of medical waste, as demonstrated in beach wash-up incidents (Turnberg, 1996). Therefore, the unconditional treatment of these items as biohazardous waste may be the result of OSHA requirements as well as prudent practice to eliminate public concerns, Syringes without needles attached were managed unconditionally as biohazardous waste by 54 percent of respondents.

Waste treatment methods used by large research-oriented universities included incineration, steam sterilization by autoclave, and management through a licensed medical-waste hauler. Surprisingly, 46 percent of the universities were using an MWH for management of over 75 percent of their biohazardous waste stream. There appears to be a growing market sector for the MWH industry. Because this disposal option requires the transportation of hazardous materials over public roads, there is a need for waste managers who employ an MWH to consider U.S. Department of Transportation requirements when developing waste policies.

With respect to on-site waste treatment methods, 90 percent of respondents indicated that they were using autoclaves for treatment of biohazardous waste, Seventy-five percent indicated that their waste was being landfilled as nonhazardous waste following this treatment. Only 47 of the 90 institutions (52 percent) using autoclaves indicated, however, that they were validating this decontamination process using a biological indicator (B. stearothermophilus) with any frequency The Council for State Government's Model Guidelines for State Medical Waste Management (1992) recommends the biological-indicator method for validating autoclave performance over other methods and further recommends testing after every 40 hours of use. Eight respondents (9 percent) indicated that they were using this validation method on a weekly or less frequent basis. Twenty-three respondents (26 percent) indicated monthly testing, four (4 percent) indicated quarterly testing, and 14 (16 percent) indicated annual testing. This variabili ty in testing frequency may be the result of individual state regulatory requirements for the process or may indicate a general weakness in the validation process.

Significantly, the results of this study indicate that nearly 50 percent (10 out of 22) of HMIWIs used in the large-research-oriented-university environment will continue to operate under stricter U.S. EPA regulations for incinerators. In contrast, the hazardous waste management industry believes that more than 80 percent of incinerators will cease to operate under stricter U.S. EPA regulations (Brunner, 1996).

This study did not include quantification of the biohazardous waste stream in the large-research-oriented-university environment. It did, however, find two trends--a large percentage of universities indicating that they were now using a licensed medical waste hauler to dispose of a major portion of their waste, and a shrinking number of incinerators--that indicate a need for further studies to examine and quantify the waste stream. Quantification of the waste stream will assist in the development of feasible, efficient, and cost-effective waste treatment alternatives for this environment.

Recommendations for Future Biohazardons Waste Program Development

Based on the findings detailed above, the authors recommend that EHS staff or biosafety personnel develop an effective biohazardous waste program through the following steps:

1. Identify activities at the university that are likely to result in biohazardous waste generation. Research applicable regulations and guidelines pertinent to these activities and integrate relevant requirements into the management plan.

2. Assess waste treatment techniques to ensure that waste is treated in the safest and most cost-effective manner.

3. Periodically review the effectiveness of treatment techniques and technological and regulatory developments. New treatment methods that are cost-justifiable are likely to be developed as regulations governing treatment techniques become more restrictive.

4. Regardless of the waste disposal method chosen, include provisions for segregation and packaging, training, and inspections of waste-generating areas as a minimum to ensure compliance with OSHA and state environmental regulations.

5. Use guidance documents such as U.S. EPA's Guide for Infectious Waste Management (1986) and the Council of State Government's Model Guidelines for State Medical Waste Management (1992) to develop biohazardous waste management programs. Although the technological information is dated, these documents contain valuable information about program development and waste-handling practices that are not restricted to the medical-waste portion of the biohazardous waste stream

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TABLE 1

Summary of Regulations and Guidelines Impacting Biohazardous Waste
Management

Agency                             Regulation/Guideline

U.S. EPA (1989)                    Medical Waste Tracking Act



U.S. EPA (1997)                    Medical Waste Incinerators
                                   Final Rule


CDC and NIH (1999)                 Biosafety in Microbiological
                                   and Biomedical Laboratories


NIH (2001)                         Guidelines for Research Involving
                                   Recombinant DNA Molecules



USDA/Animal and Plant Health       Animal and Plant Health Inspection
Inspection Service (1997)          Service (APHIS) requirements



U.S. DOT (1991)                    Hazardous Materials Regulations




OSHA (1990)                        Bloodborne Pathogens Standard



Joint Commission on Accreditation  Accreditation requirements for
of Healthcare Organizations        health care settings
(JCAHO) (1995)



Institute of Laboratory Animal     Accreditation requirements for
Resources (1996)                   animal resource operations



Agency                             Relevance

U.S. EPA (1989)                    Although not reauthorized, serves
                                   as basis for most state medical
                                   waste programs

U.S. EPA (1997)                    Part of Clean Air Act Amendments
                                   that has set restricted emission
                                   standards on HMIWIs

CDC and NIH (1999)                 Outlines requirements for waste
                                   decontamination when working with
                                   human pathogens

NIH (2001)                         Outlines requirements for waste
                                   decontamination when working with
                                   genetically modified organisms,
                                   including plants

USDA/Animal and Plant Health       Permit requirements regarding
Inspection Service (1997)          environmental release of
                                   genetically modified organisms that
                                   may be plant pests

U.S. DOT (1991)                    Packaging, labeling, and
                                   documentation requirements for
                                   transportation of biohazardous
                                   waste

OSHA (1990)                        Defines medical waste; requirements
                                   for handling, storage, and labeling
                                   of medical waste

Joint Commission on Accreditation  Require written plan addressing
of Healthcare Organizations        state and federal requirements
(JCAHO) (1995)                     biohazardous waste as well as goals
                                   and performance standards for waste
                                   management

Institute of Laboratory Animal     Procedural requirements addressing
Resources (1996)                   packaging, labeling, transportation
                                   storage, and decontamination of
                                   waste

TABLE 2

Most Critical Provisions for Ensuring Compliance with Policies

Administrative Control Provision                 Percentage of
                                                  Respondents

Training requirement for waste generators             30
Segregation and packaging requirements                26
"Manifesting" of waste                                10
Inspections of waste generation/treatment areas       23
Emergency contact information                          1
Contingency plans for disposal                         1
Additional training requirements                       2
 for those who treat own waste
Other                                                  7

REFERENCES

Bloodborne Pathogens Standard [OSHA], 29 Code of Federal Regulations [section] 1910.1030 (1990).

Brunner, C.R. (1996). Medical waste disposal. Reston, VA: Incinerator Consultants, Inc.

Centers for Disease Control and Prevention & National Institutes of Health (NIH). (1999). Biosafety in microbiological and biomedical laboratories. Washington, DC: U.S. Government Printing Office.

Council of State Governments. (1992). Model guidelines for state medical waste management. Lexington, KY: Author.

Guidelines for Research Involving Recombinant DNA Molecules [NIH], 66 Federal Register 57970 (2001).

Higher Education Publications, Inc. (1999). Higher education directory. Falls Church, VA: Author.

Institute of Laboratory Animal Resources. (1996). Guide for the care and use of laboratory animals. Washington, DC: National Academy Press.

Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests [USDA], 62 Federal Register 23956 (1997).

Joint Commission on Accreditation of Health Care Organizations. (1995). Accreditation manual for hospitals. Chicago, IL: JCAHO Publications.

Medical Waste Incinerators Final Rule, 62 Federal Register 48348 (1997).

Medical Waste Tracking Act [U.S. EPA], 40 Code of Federal Regulations [section][section] 2, 259 (1989).

Occupational Safety and Health Administration, Standard Interpretation and Compliance Letters. (June 21, 1994). Applicability of 1910.103 to establish human cell lines. Washington, DC: U.S. Government Printing Office.

Performance-Oriented Packaging Standards; Revisions and Response to Petitions for Reconsideration, Final Rule, No. HM-#181 [U.S. DOT], 56 Federal Register 66142 (1991).

Turnberg, W (1996). Biohazardous waste: Risk assessment, policy and management. New York: John Wiley & Sons.

U.S. Environmental Protection Agency Office of Solid Waste. (1986). EPA guide for infectious waste management. Washington, DC: U.S. Government Printing Office.

Corresponding Author: Catherine M. Neumann, Associate Professor, Department of Public Health, Oregon State University Corvallis, OR 97331-6406. E-mail: [e-mail].