Laboratory Regulatory Reform Task Force
Report to Cal/EPA Department of Toxic Substances Control 1995
II. Introduction and Process
In November 1994, the Director of the Department of Toxic Substances Control (DTSC) convened the Laboratory Regulatory Reform Task Force to consider the issue of regulation of laboratories. The Director specifically said that it was "critically important that the regulatory systems developed by the department do not unnecessarily adversely impact California's laboratory community." The charge to the Task Force was to recommend improvements to the regulatory system that took into account the operational needs of laboratories along with the needs of public agencies to ensure the protection of the environment.
The Task Force was asked to develop recommendations that could both be implemented under the current system and that would reflect a "completely new approach to regulating laboratories." The state and laboratory communities could derive immediate benefits from short-term improvements achieved through "tweaking" the current regulatory system through enlightened, knowledgeable interpretations of statutes and regulations. Recommendations for bold new strategies, such as a performance based regulatory system, would undoubtedly require more time to put into place but may come closer to providing a real fix to longstanding regulatory issues.
The Task Force included approximately fifty representatives from a wide cross section of California institutions and organizations concerned about the regulation of laboratory waste, including public and private universities, government laboratories, biotechnology and pharmaceutical organizations, industry, hospitals, and governmental agencies. (See Appendix A for a complete listing of Task Force Members.) Participants included university senior management, research administrators, professional hazardous waste managers, scientists and lawyers, as well as federal, state and local regulatory representatives. The full Task Force met over six months to develop these recommendations. Subgroups were appointed to closely examine several technical issues including needed regulatory changes, the domestic sewage exclusion in California, mixed wastes, and small quantity generator exemptions, among others.
The following discussion and recommendations represent a consensus by the members of the group on how the state should proceed in rethinking the regulation of laboratory waste. While not every member and represented organization would place the same emphasis on the group's recommendations, the group agreed that laboratories do have unique characteristics that separate them from manufacturing and other industrial settings, and that these needs must be reflected in the approach taken by regulatory agencies.
There was agreement that the recommendations in this report will result in important improvements over the current system and are useful first steps in the continuing need to develop a sensible process for regulating laboratories.
The DTSC brought together this group in the same way as it had previously discussed and reviewed compliance issues with other specialized groups in the state, including electronics manufacturers. This reflects the Department's intention of working with specialized groups that have particular needs and circumstances vis-a-vis the regulatory system in order to fine-tune implementation in a way that protects the environment, comports with legal requirements, and accounts for the needs and practices of such specialized waste generators.
Generators of laboratory waste, both public and private organizations, have experienced numerous and differing enforcement and compliance interpretations from local, state, and national regulatory agencies. For the most part, such differing interpretations have led to significant differences in how hazardous waste programs at laboratory facilities and institutions are managed. In certain instances, some laboratory facilities and institutions have had significant compliance actions brought against them by the cognizant regulatory agency while others that were inspected, and who were following the same hazardous waste management practices, were found to be in compliance with the same regulations. This difference in interpretations has occurred within the same region, within the same state and throughout the country. For the most part, such violations in those instances cited came about because the laboratories' methods for assuring the proper management of hazardous waste do not comport with the paperwork and organizational requirements that some agencies impose on generators, requirements on how an organization's own management system must be operated.
This situation has led to a number of conferences and reports to discuss these issues and to try to suggest workable solutions. These documents agree on some basic regulatory problems posed by the laboratory generators. Laboratories produce a very small amount of the nation's chemical waste; according to EPA reports, only about 1/100 of 1% of hazardous waste generation. Yet, paradoxically, this small involvement in waste generation has worked against laboratories. Because the laboratory community is such a small generator overall, enforcement agencies have not been compelled to look at the unique needs of laboratories in complying with the goals of environmental regulation.
Additionally, there are already numerous other regulatory agency controls pertaining to hazardous materials use, handling and storage in the laboratory that already provide for oversight of laboratory activities. These existing regulatory requirements control quantities, handling and storage of hazardous materials, environmental emissions, emergency contingency planning and response, and occupational safety and health within the laboratory. This existing control of the laboratory environment by other regulations and agencies is already adequate to provide for health, safety and environmental protection. Regulating these same chemicals within the laboratory as hazardous waste provides no added value to these goals, yet does add significant and unnecessary duplication of regulatory oversight and administrative requirements.
One significant method for streamlining regulatory agency interactions with the regulated community is to eliminate or minimize areas where overlapping jurisdictions by regulatory agencies occur. Duplication of agency effort, regulatory reporting by the regulated community, and oversight of the same material by two agencies is unnecessary for the protection of public safety and the environment, and a waste of valuable resources by both the regulated community and government agencies.
All too often, inappropriate standards developed for large-scale waste generators have been applied to laboratories despite the obvious inequities this caused. A number of groups have noted this problem from a national perspective, including the American Chemical Society and the Government-University-Industry Research Roundtable (GUIRR). The latter group, jointly sponsored by the National Academies of Sciences and Engineering and the Institutes of Medicine, held a national workshop and prepared a paper entitled "The Management and Cost of Laboratory Waste Associated with the Conduct of Research" (Appendix B). The group found that while laboratories as a whole produce very little of the nation's waste, hazardous waste regulatory issues are becoming a growing issue for laboratories. Some laboratories have been forced to modify or limit the research they do because of unnecessary waste management requirements. An entire research community could be hampered due to the costs of waste regulations. Many of those costs are due to unnecessary activities to meet inappropriate regulatory requirements that do nothing for environmental protection. This is the situation that needs to be addressed. The California Laboratory Regulatory Reform Task Force has undertaken the first critical examination of this issue to date; the resulting recommendations represent the opinion of the membership of this diverse group.
IV. Characteristics of Laboratory Operations
Laboratory activities and compliance practices are inherently different from manufacturing and industrial operations that have traditionally served as the model for the hazardous waste laws and regulations. Accordingly, several terms that have a clear meaning in an industrial setting such as the "process" which generates the waste, or the "operator" of the process generating the waste are considerably more difficult to apply clearly to research and teaching activities. This lack of clarity has resulted in confusion between both regulatory agency representatives and laboratory users.
Unlike typical industrial and manufacturing processes, hazardous wastes generated in research, instructional and analytical activities are typically produced from small volumes of a large variety of hazardous materials, which are used in an even larger number and variety of experimental procedures.
At most of the larger educational, research, and analytical laboratory facilities, hazardous wastes are typically managed by one or more trained environmental health and safety professionals. When instructors, researchers or other laboratory personnel at such facilities have no further use for a chemical or product, which may be a hazardous waste upon disposal, an environmental health and safety (EHS) professional is called upon to manage these materials. The technically qualified staff then determines whether the materials can be managed onsite (e.g., by being used, reused, recycled or treated), or disposed of off-site. Materials that can be used, or reused without being reclaimed or recycled, are sent to the appropriate user. Materials that EH&S staff determines meet the criteria for regulated hazardous waste are then labeled and managed in accordance with hazardous waste regulations.
Hazardous materials used in laboratory activities are typically stored in small containers, ranging in size from a few milliliters to five gallons. The same containers are often used by many researchers and instructors, and are stored in or near the laboratory or classroom area where these individuals work. These small quantities of chemicals are labeled and managed with appropriate attention to safety issues such as secondary containment, segregation of chemically incompatible materials, and personnel training.
Hazardous waste reduction efforts in research, teaching, analytical and other laboratory facilities generally include such steps as encouraging researchers and instructors to minimize the generation of hazardous waste. Strategies to accomplish this include purchasing and using smaller quantities of hazardous materials, microscale experimentation, and integrating steps into their research and teaching processes that reduce the toxicity and/or quantity of hazardous waste. This includes, for example, adding to laboratory procedures such basic steps as neutralization of acid or base solutions. Because researchers require assurance of a uniformly high quality of chemicals, at some facilities researchers are also encouraged to operate their own recovery and reuse processes for chemicals such as solvents. These bench-scale processes typically have a one to five gallon capacity, and can substantially reduce total chemical usage in research, teaching and analytical facilities, while minimizing the amount of regulated hazardous waste requiring off-site disposal. These practices at laboratory facilities have not resulted in any known increased risk to human health or safety, or in any increased risk to the environment. In fact, restricting some of these practices in the manner that would be required under some recent interpretations put forward by some regulatory agency representatives could actually increase the volume, toxicity, handling and transportation of hazardous wastes, thereby increasing risks to human safety and the environment.
Defining The Laboratory Environment
By function and design, laboratories differ radically from business and industrial manufacturing operations that utilize hazardous materials and generate hazardous wastes. Laboratory operations may be performed by hundreds of individual researchers, teaching assistants, graduate students or post-doctoral fellows at a particular academic, government or commercial laboratory facility. These procedures generally produce small quantities of a constantly changing variety of chemicals. Some of these chemicals can be reused in other laboratory processes or facility operations.
It is unrealistic for the tens of thousands of researchers at a large institution or campus to know what is involved in each others' research and, therefore, what could be recycled or reused. For many larger facilities, the environmental health and safety compliance manager and staff have a much broader perspective from which to make these determinations .
At issue is the definition of a laboratory for purposes of appropriate application of the hazardous waste control law regulations for laboratory facilities. The Task Force recommends the laboratory definition developed and standardized by OSHA in its development of a regulation specifically for laboratories as appropriate to defining the laboratory boundaries. This provides the basis for many of the Task Force recommendations to follow. This issue is further discussed in the first recommended action.
Existing federal and state regulations (29 CFR 1450 and 8 CCR 5191) provide the following definitions:
"Laboratory" -- means a facility where the laboratory use of hazardous chemicals occurs. It is a workplace where relatively small quantities of hazardous chemicals are used on a non-production basis.
"Laboratory scale" -- means work with substances in which the containers used for reactions, transfers, and other handling of substances are designed to be easily and safely manipulated by one person.
The Task Force believes a reasonable extension of this concept, based upon these existing regulatory definitions, is the defining of the "Laboratory Process Unit" (LPU). The LPU concept requires the handling or use of chemicals in a laboratory in which the following conditions are met:
- Chemical manipulations are carried out on a "laboratory scale",
- Multiple chemical procedures or chemicals are used;
- Protective laboratory practices and equipment are available and in common use to minimize the potential for employee exposure to hazardous chemicals.
- Laboratory processes are undertaken by or under the supervision of a qualified individual.
Numerous statutory and regulatory requirements already exist for the control of hazardous substances handling, use, storage, and worker safety in laboratories. Appendix D details only some of the many existing regulatory requirements for laboratories. The Task Force believes that these regulations provide for appropriate levels of safety, health and environmental protection within the laboratory environment. We also believe that adding and extending the hazardous waste control laws into the laboratory unnecessarily duplicates existing regulations in this setting, provides no added value to environmentally sound management of laboratory wastes, and adds unnecessary administrative procedures to laboratory operations.
V. Consequences-- Costs and Regulatory Issues
Laboratories have faced many problems in following the changing requirements of regulatory bodies. Over the past year, several issues have been raised relating to the interpretation and application of the hazardous waste control laws to laboratory activities. Some of these interpretive issues have arisen in the context of Management Memoranda or Fact Sheets distributed by the DTSC. As a general matter, the Task Force is concerned that these new and evolving regulatory interpretations are causing substantial increases in compliance costs without any commensurate environmental or public safety benefit. We are also concerned that these significant and costly regulatory interpretations were issued and became immediately effective without any process for public review and comments. Taken together, these circumstances are having a serious effect on California's laboratory facilities and research enterprise.
These institutions and organizations already train their staff regarding proper handling of hazardous materials. This is important for good safety management, and covers all hazardous chemicals. Laboratory staff are versed in the hazards of the materials they use and the need for proper identification and labeling of materials. The training and other administrative elements required by the DTSC Management Memorandum and Fact Sheets focus on having the laboratory personnel become fully informed and aware of all the regulatory nuances and requirements for regulated hazardous waste management, as well as require duplication of effort in filling out forms and labels. When an organization already has professional staff to manage this aspect of the program, there should be no need for the duplication of effort and resources in an attempt to make regulatory experts of every laboratory person.
Unnecessary regulatory restraints are hampering research facilities in California, especially compared to those in many other states, and could affect the long-term economic well-being of the State. In just one example, the University of California, San Diego (UCSD), noted that current regulatory interpretation would require the campus to train all laboratory employees in the nuances of hazardous waste handling. UCSD has over 1,400 laboratories and 14,000 laboratory personnel that use hazardous materials. Laboratory employees do not currently make hazardous waste determinations or process hazardous waste from laboratories for disposal; these tasks are performed by the professionals in the Environmental Health and Safety office. This unneeded training is estimated to cost the campus over $322,000 per year (18,600 hours x lab technician salary of $17.35 per hour). Requiring laboratory personnel to perform waste determinations uses another 36, 400 hours and costs $632,000. Additional requirements restricting bench top treatment of hazardous waste add about 10% to UCSD's hazardous waste disposal costs, about $22,000. Thus, for one campus at UC, such costs amount to $976,000. The whole UC system could save approximately $5,000,000 which could be better focused on research and teaching if agencies implemented waste control regulations in ways that took into account the ways laboratories are actually managed by universities and other laboratory organizations.
Given recent substantial decreases in research and operational support funding, particularly in university and government agencies, the Task Force is particularly anxious to ensure that environmental compliance requirements for laboratories are directly linked to preventing or avoiding environmental or public safety problems and do not add unnecessary and costly administrative processes.
VI. Goals of Laboratory Waste Regulation
The Task Force agreed that a number of goals should be met by the state's regulatory system for laboratory waste:
- Regulatory interpretations should be protective of the environment.
- Interpretations of regulations by state agencies should be clear ; consistent with legal requirements; feasible in a laboratory setting; and cost-effective in achieving environmental, health and safety objectives.
- Regulatory interpretations should be consistent throughout the state; state and local agencies should develop common requirements, forms, standards, and sanctions for enforcing federal, state, and local laws.
- Regulatory enforcement should focus on standards of performance rather than command/control requirements and administrative processes established for industrial-scale operations that are unnecessarily burdensome in a laboratory setting.
- Provision should be made for generator flexibility and options for on-site, internal management of hazardous materials and hazardous wastes at laboratory facilities.