NIH Regulatory Burden: Hazardous Waste Disposal

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NIH Regulatory Burden
VII. Hazardous Waste Disposal - Workgroup Report

Background

The Federal Government, through the Environmental Protection Agency (EPA), has promulgated regulations and policies that govern the disposal of hazardous wastes. The EPA regulations (40 CFR Subchapter 1) flow from the Resource Conservation and Recovery Act (RCRA). Further policy guidance is provided in management memoranda.

While the RCRA regulations are the main focus of this study, there is a variety of other Federal legislation that impacts research institutions in this general area. Most notable is legislation related to worker protection, nuclear materials, and clean air. The Occupational Safety and Health Administration (OSHA) regulates worker protection from chemicals and hazards; a Chemical Hygiene Plan must be developed for each laboratory, including work practice standards for handling chemicals, control measures, and additional protection when handling toxic and carcinogenic materials. The Nuclear Regulatory Commission (NRC) regulates radioactive waste; however, if the substance is a mixed waste, i.e., if radioactive waste is mixed with hazardous waste, the respective components of the mixture are regulated by NRC and EPA. EPA also regulates the Clean Air Act and is currently considering including Research and Development as a source category of hazardous air pollutants. In addition to the Federal laws, a variety of State laws also govern various aspects of laboratory regulation. These State laws may be more restrictive than the Federal laws.

In order to identify the research community’s view of opportunities for streamlining, a workgroup of research institution officials was convened. The workgroup was diverse, containing research investigators, Directors of Health and Safety for research institutions and officials having institutional responsibility for the enforcement of Federal regulations at the institution. This diversity is necessary in order to capture the perspective both of those performing the research and those that are charged with developing, implementing and overseeing the disposal of hazardous wastes. A listing of the individuals serving on this workgroup is included in Appendix 2.

The specific task assigned to the members was to develop proposals to reduce regulatory burden in the treatment, storage, and disposal of hazardous waste material. While the members generally concentrated on the impact of RCRA, it was sometimes necessary to include aspects of other regulations in the discussions because of the considerable overlap.

Current Requirements

The RCRA regulatory requirements are quite voluminous and quite complex, numbering in the hundreds of pages. In fact, the orientation manual developed by the EPA entitled RCRA Orientation, a manual described as providing an "introduction" to the various facets and basic structure of the RCRA program, is over 200 pages in length. It is obviously not possible to summarize the totality of the regulations for this paper in any meaningful way. What follows are those sections of the regulations that members of the research community find to be most at issue.

Waste Determination – 40 CFR 262.11 states that the person who generates the waste must determine if the waste is hazardous by ascertaining first, if the waste is excluded from regulation, and, if not, if it is listed as a waste in the RCRA regulations under 40 CFR 261. If it is not listed, the individual is still required to assess whether it meets the requirements of being classified as a hazardous waste by testing the waste according to methods set forth in the

Waste Generator Status (accumulation times) – 40 CFR 262.34 defines three categories of organizations that generate waste in terms of the quantity of waste that is generated per month; it also defines the length of time that these organizations can store these wastes depending on their status.

Large Quantity Generators (LQG) are institutions that generate more than 1,000 kg. of hazardous waste per calendar month or more than 1 kg. of acutely hazardous material per calendar month. LQGs may accumulate hazardous waste on-site for up to 90 days. They must comply with requirements for proper management of wastes (proper accumulation in closed containers that are appropriately labeled and marked with the date that accumulation began, and documentation that the waste was shipped within the 90 days); a formal written contingency plan and emergency procedures in case of a spill; and training in the proper handling of hazardous waste through an established training program.
Small Quantity Generators (SQG) are institutions that generate between 100 kg. and 1,000 kg. of hazardous waste per year and accumulate less than 6,000 kg. of hazardous waste at any time. SQGs may accumulate wastes for up to 180 days, or 270 days if it is being transported off-site at a distance greater than 200 miles. They must comply with lesser requirements for management than the LQG (proper accumulation in containers that are appropriately labeled and that are marked with the date that accumulation began); specific emergency responses but no formal written contingency plan; and employees familiar with proper handling and emergency procedures but a training program need not be established.
Conditionally Exempt Small Quantity Generators (CESQG) are institutions that generate less than 100 kg. of hazardous waste per calendar month or less than 1 kg. of acutely hazardous waste per month. CESQGs are not required to comply with accumulation and storage requirements but must identify their hazardous waste, must comply with storage limit requirements, and must treat or dispose of their waste at an approved site.
An institution, regardless of its designation, may accumulate up to 55 gallons of a hazardous waste or one quart of acutely toxic waste in a satellite area that is defined as "...at or near the point that the waste was generated…" and is "...under the control of the operator of the process generating the waste." Once either limit is reached, it must be removed within 3 days.
The accumulation times specified above can also apply to mixed wastes that contain radioactive material.
If SQGs or CESQGs exceed their storage quantity limits, or if LQGs or SQGs exceed their storage time limits, they become a storage facility, with additional regulatory requirements including the need for a permit.
Because generator status is determined on a monthly basis, it is possible for an institution’s status to change from month to month. They are required to comply with the regulations that are pertinent for that particular month.

On-site determination/Manifesting – EPA tracks and monitors generators by assigning them unique EPA ID numbers. Numbers are assigned to sites that are considered to be contiguous, i.e., along a public or private right-of-way within or along the border of "…contiguous property under the institution’s control." This provision has been recently liberalized to allow travel along a public road from one portion of the institution to another, as long there is no other intervening private property. If campuses within the same University, or portions of the same campus, do not meet this definition of contiguous and generate hazardous wastes, two or more ID numbers are assigned. Separate recordkeeping is required for each unique ID number.

In addition, 40 CFR 262.20 requires that a generator that transports hazardous wastes off-site for treatment, storage, or disposal must prepare a detailed manifest. This manifest identifies the institution, the hazardous wastes, the quantities of the wastes and the container types. It also must contain a certification that the information is true, that the institution has a waste minimization program, and that the methods followed are the most practicable and minimize risks to health and the environment. These manifest requirements do not apply to the transportation of hazardous wastes on-site.

Labeling – 40 CFR 262.34 requires the generator to mark containers that contain waste with the words "Hazardous Waste" or with other words that identify the contents of the container. 40 CFR 261.4(e) allows an exclusion from the labeling requirements for various types of samples.

Closed Containers – 40 CFR 265.173(a) requires that a container must always be closed during storage, except when it is necessary to add or remove waste.

On-site Treatment – Regulations permit treatment in the accumulation tank or container, recycling (as in solvent distillation) and elementary neutralization (as in pH adjustment). All other on-site treatment requires a permit.

Identification of Intent of Hazardous Waste Disposal Protections

In order to put potential issues and solutions into the appropriate context, members identified the intended level of protections, i.e., the objectives that must be achieved if a program of hazardous waste disposal is to be considered effective. It is the members’ view that the protections that should be achieved by the federal regulations and the objectives of a credible program are as follows:

The program should provide cradle-to-grave management of hazardous waste that will protect the employee, the environment, and the public health from risks associated with the disposal of hazardous wastes.

The program should strike a rational balance between risks and benefits and must flow from rigorous scientific analysis. In regulating the environment, as in regulating any aspect of public health, there is unfortunately no such thing as "absolute safety".

The program should represent a partnership between the EPA and the research community as they share a common objective to protect the environment and leave a long-term legacy to the American people. This partnership should have, as its foundation, a mutual trust and respect, and a willingness by both parties to work collaboratively to achieve these shared goals.

The program should maintain a consistent set of standards or objectives to which research institutions should be held accountable. At the same time, the program should be sufficiently flexible to accommodate alternative methods of achieving the desired outcome. Model guidance, collaboratively developed, would be useful in facilitating these shared outcomes.

In examining existing legislation, regulations, policies and practices, the members agreed that a credible policy of protections regarding hazardous waste disposal had to achieve these objectives. Any changes proposed to reduce regulatory burden should be consistent with, and foster, the achievement of these objectives.

Identification of Issues of Concern

Following the development of the objectives that a hazardous waste disposal program must achieve, the members identified those issues that were of concern. This list includes issues related to the legislation, the regulations and the inconsistency between the States and the Federal government on some aspects of the regulations, interpretation of the regulations and practices of the agencies.

It should be noted that the purpose of the workgroup was not necessarily to come to consensus. While there was general agreement on the issues and the proposed solutions, there was not necessarily unanimity on each.

The definitions of waste and of who makes those determinations, which are contained in the RCRA regulations, are likely appropriate for a chemical manufacturing plant but are not easily applied to the laboratory. The EPA generally interprets that materials become wastes when a "process" is complete, and "processes" are normally interpreted to be single steps in an experiment. Members observed that the laboratory environment differs from the industrial environment where a defined product is created and waste occurs as a byproduct. In the research environment, the end product – knowledge – is not time-limited and it is better described as a continuing process where small volumes of a wide variety of wastes that are often not well characterized are generated. The net result of imposing this definition on the laboratory is that it forces a decision on defining a small amount of material in the laboratory as a waste before it can be assessed for possible reuse or recycling. In a related matter, members observed that under the current definitions, material sent for recycling is considered to be a waste in defining generator status and in determining resultant fees; there is no "credit" for recycling at off-site facilities.

Regarding the corollary issue of who makes the determination that a material is a waste, the regulations (40 CFR 262.11) state that the person who generates the waste must determine if the waste is hazardous. In a laboratory setting, this would be the scientist. However, there are other individuals better able to make such a determination for the institution; workgroup members contend that there is no obvious disadvantage to allowing them to do so. This definition also triggers training requirements for laboratory workers (e.g., including labeling requirements, definition of appropriate container, method of offering waste for disposal site, etc., in addition to OSHA training requirements) that members observe to be excessive and inefficient.

Other definitions or restrictions are also problematic for the research environment. Those specifically mentioned by the members include:

On-site treatment – Members observed that that current regulations are being misinterpreted to permit on-site treatment under only very limited circumstances, and that this misinterpretation is resulting in significantly less treatment of wastes than could otherwise be occurring.
Contiguous sites - Research institutions are often decentralized and geographically fragmented but within relatively close, but not contiguous, geographical proximity. When a campus is considered to be more than one site, maintaining a single central accumulation site is difficult. While transporting wastes from each site to a central accumulation facility may provide economies of scale, it requires a cumbersome manifesting process resulting in institutions manifesting waste shipments to itself. It also results in a higher generator status.
Closed containers - The regulations require that a container must always be closed during storage, except when it is necessary to add or remove waste. The seeming rigidity of this requirement often results in difficulties for the researcher. For example, lab instruments may have effluent bottles that contain hazardous wastes and must be closed. However, researchers would prefer to have the collection tube in place at all times.

There are multiple and conflicting regulatory requirements and interpretations among the various Federal and State agencies. Examples cited by members include the conflicting requirements of EPA and NRC regarding the disposal of mixed wastes (chemical and radioactive wastes); multiple labeling requirements of EPA and OSHA as well as fire code requirements; differing interpretations of the same regulations by Federal and State agencies; and varying interpretation of Federal regulations by different EPA Regional Offices.

The time limits to dispose of hazardous wastes under SQG status (180 days) and LQG status (90 days) and their inflexibility can be inefficient and not cost effective in the research environment. In the research environment, small quantities of a large number of wastes are typically generated. These time limits often prevent the accumulation of sufficient quantities of individual substances for cost-effective disposal. Members also note that the designations do not accommodate random fluctuations in the amount of waste generated in a given month. Such fluctuations may cause an entity to move from one generator status to another for that month. The fluctuations could merely be the result of an investigator pursuing a new research lead. A member reported an example of a CESQG at his university, that was generating less than 10 kg of waste per month, suddenly becoming an SQG or LQG because it temporarily generated more than 1 liter of acutely hazardous material. This was not considered to be an infrequent occurrence.

The current relationship between the EPA and the research community is adversarial. This is at odds with the collegial nature of the academic environment and also at odds with the relationship that research institutions generally have with Federal science agencies.

Certain paperwork requirements may not be currently satisfying their intended purpose. Specifically mentioned were waste minimization plans, EPA’s Biennial report, and community right-to-know requirements. EPA requires that organizations submit a waste minimization plan each year. In an industrial setting, progress can be measured by declining ratios of wastes generated per product. Waste minimization, however, is not as easily measured in a research environment, as there is no product in research. In addition, members contend that the range of possibilities may be more limited because of the need to follow specific procedures or use certain materials in the conduct of the experiment. Another candidate for examination is EPA’s Biennial Report. The information requirements and layout are quite cumbersome for institutions that generate many waste codes. Similarly, community right-to-know requirements impose significant reporting requirements but from the members’ perspective, this report is of limited use. While supportive of the general purpose of these plans and reports, members suggest that these requirements are not fulfilling their intended purpose in their current format.

The net effect of these issues is to question the cost effectiveness of the current waste management requirements as they apply to research institutions and to emphasize the need for flexibility and simplification. The members were very supportive of the approach taken in the proposal drafted by several northeastern universities under EPA’s Project XL demonstration program. They believe that it has the potential to tailor a flexible program of hazardous waste management based on performance standards that is more consistent with the research environment. This demonstration project is being proposed by Boston College, the University of Massachusetts-Boston, and the University of Vermont, and is currently in its final stages of negotiation with EPA. It seeks to achieve superior environmental performance by managing wastes under a program that adheres to the spirit of RCRA, but with sufficient flexibility that it avoids many of the inefficiencies that currently occur because of the necessity to adhere to the letter of RCRA. By setting performance standards through a "Laboratory Environmental Management Standard" and seeking exemptions from regulatory language that creates many of the inefficiencies noted above, the Universities intend to demonstrate superior waste management.

Proposed Solutions to Reduce Regulatory Burden

As noted above, in developing solutions, the group emphasized the need to assure, at the outset, that these proposed solutions must not compromise the items identified earlier as the intended levels of protection. Many of these solutions are not new and have been recommended by others in various reviews. In addition, many of these recommendations are consistent with the basic provisions of the Project XL draft proposal described briefly above. The members were very supportive of these provisions as they represent changes that the research community has been advocating for many years. Their only misgiving is the frustration that a time-consuming demonstration project is necessary to prove what they perceive to be obvious. While pleased that progress is being made, however slowly, those who operate in the research environment and experience the inefficiencies of the RCRA procedures and their inapplicability to the research environment, are frustrated by the pace and believe that many of these changes should be made immediately. Recommendations from the members are as follows:

A paradigm shift is needed - Waste management regulation should be performance-based; coupled with this approach should be a priority on research on new treatment and processing technologies. The members were impressed with the performance-based approach that underlies the Project XL draft proposal. The ability to meet performance goals such as those articulated in its proposal, and then holding the institutions accountable to meeting those goals, is a regulatory model that should be embraced by EPA in overseeing hazardous waste disposal at research institutions. Another model that members have found to be a "best practice" is the Hazard Analysis and Critical Control Point (HACCP) . This is a performance based system that was originally developed for the space program and has been adapted as a prevention-based food safety system. Adoption by EPA of systems such as these will allow the research institutions to undertake hazardous waste programs that are consistent with the research institutions’ environment but satisfy the program objectives of EPA. Finally, as representatives of the scientific community, members are confident of the potential of research in yielding more cost-effective methods for treating and disposing of wastes, and encourage its support.

Several definitions, critical to research institutions, should be amended or clarified.

RCRA waste determinations should be made at the institutional level at the central consolidation or accumulation point. Members agree that RCRA waste determinations should be made by the institution, not the laboratory scientist. Providing this flexibility would allow the designated representative of the institution to be responsible for making a waste determination; in most cases this would likely be an Environmental Health and Safety Specialist. In addition, the determination of a laboratory waste should be made by the researcher. Moving the point of generation of hazardous waste outside the laboratory, and allowing the determination to be made by a trained environmental health and safety expert, rather than a scientist, will allow the institution to make the best possible decisions on the feasibility of recycling and reuse. Finally, this interpretation would resolve the issue of open vs. closed containers mentioned above. These determinations are consistent with the draft Project XL proposal and members suggest that they be extended to all research institutions.

On-site treatment should be allowed at a central accumulation site prior to declaration of RCRA waste status. Members agree with the clarification proposed in the draft Project XL project that would allow a generator to treat waste in an accumulation tank or container. This language is contained in 51 FR 10168, dated March 24, 1986. With this clarification, the options available to research institutions for treatment of wastes, short of requiring a Part B permit, would be treatment in containers, recycling, and elementary neutralization.

Multiple sites that are geographically proximate should be allowed to have one waste generator ID code. As mentioned above, university campuses, or portions of the same campus, that are proximate but do not meet the EPA definition of contiguous, require separate ID codes. This creates considerable administrative burden by requiring multiple record-keeping systems and by requiring the institution to essentially manifest the wastes to itself when transporting them to a central campus accumulation point. The flexibility to maintain a single generator ID code for geographically proximate sites would eliminate the duplicate record-keeping and the need for manifesting over relatively short distances between campuses, or within the same campus.

OSTP, on behalf of the research community, should convene an action task force to evaluate and rationalize the administration of environmental regulations as they pertain to research institutions. At the present time there is no effective Federal mechanism for reconciling conflicting regulations that may be imposed by EPA, OSHA, and NRC, or to assess whether environmental regulations are written and administered so as to be compatible with the research environment. Members propose that these regulations be systematically reviewed to eliminate conflicting provisions and to provide the flexibility to allow the adaptation of regulations, possibly written with other industries in mind, to the research environment. Members also suggest evaluation of extensive reporting requirements, such as community right-to-know, the EPA Biennial Report, and waste minimization reporting, to assure that they are achieving their intended purpose. The members suggest that the participants in this process be of sufficient seniority to be able to commit their Agency to action, within the restrictions of the Administrative Procedures Act.

In making this suggestion, members reiterate their commitment to sound programs of environmental protection. Their purpose is not to diminish existing protections or to lessen their institution’s accountability, but to eliminate overlapping regulations and allow research institutions to adapt the regulations to their environment.

EPA and the research community should establish a partnership, based on trust and open communication, to collaboratively meet their mutual objective of environmental protection. The members conclude that a dialogue must be established to solve the issues that currently exist and to preclude their occurrence in the future. EPA, as a regulatory agency whose attention is concentrated primarily on other industries and populations, has not identified the research community as one of its stakeholders. At the same time, the research community, while aggressive in establishing strong relationships with the Federal science agencies, has not established similar relationships with agencies that, as a tangential part of their mission, regulate aspects of research. Yet, both EPA and the research community share the mutual objective of environmental protection. Several suggestions are proposed by the members:

EPA should identify the research community as a stakeholder group and work collaboratively with them in the early stages of the development of regulations, policies, and practices. An additional objective of these discussions should be a common understanding of the definition of terms as they apply to the research environment. Background material that might be useful for EPA to understand the issues of concern to the community would be Prudent Practices in the Laboratory developed by the National Research Council, The Management and Cost of Laboratory Waste Associated by the Conduct of Research, Report of a Workshop by the Government-University-Industry Research Roundtable; and pertinent documents developed by the American Chemical Society.

The research professional organizations should establish a working relationship with EPA, so that these Federal officials can better understand issues that are of significance to the research community. Research professional organizations should also periodically assess regulations, policies and procedures to assure that they are efficient and accomplishing their intended objectives within the research institutions.

Both EPA and the research community should encourage the development of other demonstration projects within the Project XL program with the aim of reducing regulatory burden and establishing collaborative relationships both at the Federal and State levels. The members appreciate the potential benefit of the Project XL program; as such, they strongly recommend that it be expanded to maximize its potential, and that the approval process be expedited for the current proposal and future proposals.

EPA and the research institutions should collaboratively reach out to the public to better explain the objectives of environmental programs and the actions taken by research institutions to accomplish those objectives.

EPA should undertake effective training programs to ensure consistent interpretation of regulations and policies by its Regional Offices, and consistent interpretation of the Federal regulations by individual States; in addition, members recommend an appeals process to resolve such issues. As noted above, differing interpretations contribute to a significant frustration within the research community. Since there is no apparent mechanism to resolve such differences, members also recommend a hierarchical appeals process in which the EPA could resolve issues that arise because of differing interpretations.

Amend the regulations to allow an averaging of waste over a period of a year to determine generator status. As noted above, waste generator status is determined on a monthly basis by the volume of waste generated. However, variations in a research program may result in fluctuations in the amount of waste generated, thereby altering an institution’s generator status during the year. In order to avoid this confusion, and the consequent changes in regulatory requirements, members recommend that generator status be determined by the yearly average of waste generated.

Allow storage for decay of mixed waste and unlimited storage of waste for which there is no disposal site. At the present time, the NRC permits storage of mixed waste to allow radioactive decay. EPA, on the other hand, requires that it be transported for disposal within the 90/180-day timeframe (depending on generator status). The Committee recommends that EPA exclude the time limitation for storage of mixed waste where NRC permits the radioactive decay or where there is no disposal site. The members were pleased to hear from the EPA representative that they are drafting a regulation to allow the storage of mixed waste without a Part B permit. The EPA expects to have this proposal available for comment in October 1999.

Workgroup members are confident that with the implementation of many or all of these changes, the objective of the NIH initiative would be achieved with respect to the regulations governing hazardous waste disposal – the existing regulatory procedures would be made more efficient without reducing the intended levels of protections.