The cutting-edge research and development conducted in California's educational, commercial and governmental laboratories has been, and will continue to be, a major determinant of the overall well-being and economic prosperity of both the state and the nation. However, these laboratories are finding it increasingly difficult to focus on their research mission because of unnecessarily burdensome hazardous waste regulations that provide no additional benefit for the protection of public safety or the environment.
There is no question that the hazardous waste generated from laboratories must be regulated. The problem is that the laws and regulations governing hazardous wastes were written primarily for large-scale manufacturing processes, not for the very different types of activities conducted by laboratories, which generate only about 1/100 of 1% of the nation's hazardous waste. Regulatory agencies, therefore, have had to decide how to apply these laws and regulations in the laboratory setting, often with little understanding of how a laboratory operates. The result has been a confusing array of regulatory interpretations at the federal, state and local levels. In California, laboratories have been particularly concerned with the regulatory interpretations put forward over the last year by the state's Department of Toxic Substances Control (DTSC).
In response to this concern, the Director of DTSC convened the Laboratory Regulatory Reform Task Force in November 1994 to consider the issue of hazardous waste regulations as they apply to laboratories. The Task Force was asked to develop two types of recommendations: 1) those that could be implemented under the current system, and 2) those that would reflect a "completely new approach to regulating laboratories." Because of time constraints, the Task Force -- which included representatives from a wide cross section of California institutions and organizations --focused primarily on developing the first set of recommendations. Task Force members agreed that fundamental new approaches to regulating laboratories should be explored further, it believes the recommendations in this report, when implemented, will address the issues of critical concern to the laboratory communities in the state.
This consensus task force report examines thirteen issues where DTSC's current regulatory interpretations either impose unnecessary burdens on laboratories, or require clarification, and recommends ways to address each issue. The two central recommendations, and most critical issues for laboratory facilities, involve the question of who at a laboratory facility can make the regulatory waste determination, and when a material should become regulated as a hazardous waste.
Under the current DTSC interpretation, this determination must be made by each individual researcher within a laboratory as soon as that person has no further use for the material, even if the material is unused and could be used by others at the facility. The main concern with the DTSC interpretation is that it is not appropriate in a laboratory environment. In a large-scale manufacturing setting, the process is predictable and only a few types of waste are produced. Also, the amount of waste is large and relatively constant.
The Task Force believes that a better approach is to allow researchers to concentrate on research and provide a laboratory facility with the flexibility to vest the regulatory decision-making authority in technically qualified personnel designated specifically for that purpose. Adoption of this approach will provide the necessary flexibility and simplification for contiguous generator sites with multiple laboratories, without any diminution of public safety or environmental protection, and is the single most important recommendation of the Task Force.
If this approach is adopted by DTSC, the Task Force believes that most of the other issues of concern identified in this report can more easily be addressed. The other eleven recommendations in this report address the issues of:
The Task Force believes that the recommendations put forth in this report, when adopted, will help ensure that California retains its scientific and technological preeminence without any diminution in the protection of public safety or the environment. In some cases the recommendations would actually provide greater protection.
The Task Force appreciates the opportunity that has been provided to review these important issues and stands ready to work with the Department in implementing these recommendations.
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.
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.
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:
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.
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.
The Task Force agreed that a number of goals should be met by the state's regulatory system for laboratory waste:
The unique and constantly changing nature of research, teaching and analytical activities in laboratories has prompted some agencies to adopt an entirely separate regulatory program for laboratory settings The federal and state occupational health and safety programs, for example, require laboratory facilities to develop a chemical hygiene plan which is tailored to the particular laboratory facility operation and which meets specified workplace safety performance objectives. These occupational health and safety programs also require that laboratory personnel receive training adequate to perform tasks relating to hazardous materials and hazardous wastes.
It is the consensus of the Task Force that a separate regulatory program for hazardous waste generated in laboratories during research, teaching and analytical activities is not needed to address the issues identified in this report. The Task Force believes that existing statutes and regulations provide sufficient flexibility for interpretations that still ensure compliance practices which are both feasible and protective of human health, safety and the environment, but which focus on practicality and the understanding of laboratory operations.
While these recommendations logically are consistent with one another, they are also severable and if any are determined to be in conflict with current law or regulation, the others may still be adopted as short-term fixes. The Task Force believes that implementation of these recommendations for surveillance and enforcement purposes can occur immediately. However, we also recognize there may be some time constraints and suggest that notification of the California laboratory community regarding these changes be made within six months of the change.
1. The Laboratory Process
Issue: What is the appropriate definition of a "laboratory" for the reasonable application of hazardous waste control laws?
Current Interpretation: Processes are generally identified as a single step in an experiment or a single apparatus. Thus, a material is designated as a hazardous waste, by DTSC for regulatory purposes, before a process is finished or before a material can be identified for reuse or recycling.
Recommendation: Provide flexibility within the system for laboratories to appropriately manage hazardous substances or wastes within existing the regulatory framework by adopting the concept of the "laboratory process unit."
By function and design laboratory facilities differ from business and industrial manufacturing operations. The Laboratory Process Unit (LPU) better defines the operational characteristics of a laboratory. It is a definition that characterizes the operations that occur within the boundaries of the laboratory as a process unit, rather than referring solely to single pieces of apparatus within the laboratory. A schematic of the Laboratory Process Unit concept is illustrated in Figure 1.
The LPU concept provides flexibility and on-site management for the use and
handling of hazardous materials providing these conditions are met:
1) chemical manipulations are carried out on a "laboratory scale";
2) multiple chemical procedures or chemicals are used;
3) protective laboratory practices and equipment are available and in common use to minimize the potential for employee exposure to hazardous chemicals; and,
Figure 1
4) laboratory processes are undertaken by or under the supervision of a qualified individual.
One could reasonably consider the Laboratory Process Unit, therefore, as analogous to the "manufacturing process unit," which is recognized in existing regulations (40 CFR 261.4(c)). Hazardous materials would not be considered as wastes, for regulatory purposes, until they are removed from the laboratory process unit. Both the laboratory and manufacturing process units are designed by professional scientists and operated by trained personnel. Both units perform various chemical procedures and are previously regulated by other agencies for health, safety, water and air emissions.
2. Regulatory Waste Determination
Issue: Who, at a contiguous laboratory facility site, must make the determination regarding when a material becomes a waste, and who is responsible for determining the regulatory status of the waste material?
Current DTSC Interpretation: Each individual researcher in each laboratory is responsible for making a waste determination as soon as he/she has no further use for the material in the laboratory. The regulatory status of the material, including what type of defined hazards are appropriate, must be made by the hands-on operator of the experimental process, not the overall operator of the generator site.
Recommendation: Designated technically qualified facility personnel should make the regulatory waste determinations.
The regulatory waste determination can be managed outside of the laboratory process unit by the most appropriate and qualified personnel. Under this interpretation, used chemicals from laboratories would be classified and regulated as "hazardous materials" unless they were managed as waste in the laboratory (e.g., by being discarded or treated in the laboratory). A hazardous waste determination would be required prior to transporting hazardous materials to any off-site location. The determination of whether or not a hazardous material is regulated as a hazardous waste shall be made by a technically qualified person, such as an environmental health and safety professional, who has been identified by the laboratory facility as having responsibility for making the regulatory determination.
By regulation, the "generator" is the entity responsible for waste determinations. This term is defined as "any person by site, whose act or process produces hazardous wastes..." (22 CCR 66260. 10). This Task Force recommendation would recognize that the laboratory facility is the generator, rather than the individual researcher, and therefore the designated representative of the facility is responsible for making the regulatory waste determination. The determination regarding the regulatory status could, therefore, be made by a "technically qualified person," such as an environmental health and safety compliance expert, after the material was removed from the laboratory unit.
Conceptually, this is similar to existing regulatory interpretation applied in an analogous situation for hazardous waste regulatory management purposes. In accordance with an existing provision, when in a "manufacturing process unit" the hazardous material is not a waste until it is removed from the process unit (22 CCR 66261 .4(c)). In the laboratory setting, the laboratory operation itself is "the process", as defined in the laboratory process unit. Hence the material would not be a waste until removed from the laboratory process unit.
"Technically qualified person" -- For purposes of laboratory activities, a technically qualified person means a person who is capable, because of education, training or experience, or a combination of these factors, of understanding:
This interpretation would allow organizational flexibility. Depending upon the organizational structure or compliance management program of the facility, the waste determination could be made by either an assigned environmental professional or properly trained laboratory personnel. If the laboratory organization desired, the "technically qualified individual" could still be the researcher in the laboratory.
Additionally, this interpretation is critical for waste minimization programs such as chemical redistribution. If the facility has the flexibility to make the waste determination, a chemical which may be of no use in one lab could be reviewed by the institution and redistributed to another lab which has a use for the material without the chemical entering the hazardous waste regulatory arena. It is our understanding that this concept has recently been accepted by the DTSC for a major academic laboratory facility in the state. We believe this is appropriate and can serve as a model for other laboratory facilities in the state.
3. Treatment in the Laboratory
Issue: Bench Top Treatment Exclusion from Permitting
Current DTSC Interpretation: The DTSC draft fact sheet on this issue provides an appropriate mechanism for bench top treatment.
Recommendation: Bench top treatment within a laboratory (process unit) would not be subject to regulation if conducted in compliance with the conditions below:
These conditions are in general conformance with the DTSC fact sheet except for two changes. First, the time limit should be rolled into a volume limitation. Laboratory procedures and schedules, as well as waste volumes generated, are highly variable from one laboratory to another. Treatment may entail setting up different laboratory apparatus in addition to the original experimental equipment. Many laboratories do not have room to keep multiple apparatus set up all the time. Setting a time limit does not allow the laboratory to incorporate bench top treatment in the most efficient manner. Rather than set a time limit on treatment to keep materials from accumulating, the same result can be achieved by applying a maximum accumulation quantity for treatment at the bench top. Second, because the types of containers typically utilized in the laboratory are five gallons or less, and typical solvent stills have a five gallon or less capacity, the liquid volume allowable for bench top treatment should reflect these typical operating parameters.
The Task Force supports this interpretation, with the noted changes, and believes it will enhance pollution prevention, waste minimization practices, and safety in laboratories.
4. Empty Containers
Issue: Is the rinsing and reuse of laboratory glassware subject to the hazardous waste regulations?
Current DTSC Interpretation: The empty container rules do not specifically address the case of small containers in laboratories that are reused. They are exempt from regulation only if discarded or returned to a vendor, but not if reused. While this may be an oversight in the regulations, it nonetheless is a problem. Strict adherence to the current DTSC interpretation would mean that small glassware, such as test tubes or beakers intended for re-use in the laboratory, would be regulated as hazardous waste, and under the current regulations the rinsing and cleaning for re-use would constitute a "treatment" process. This regulation is more stringent than the federal RCRA requirements.
Recommendation: DTSC should implement the federal RCRA regulation on empty hazardous waste containers.
Since the rinsing of empty glassware occurs within the lab, under the Laboratory Process Unit interpretation the resulting rinsed, re-usable container would not be regulated as a solid hazardous waste while within the laboratory. Containers removed from the laboratory would be appropriately managed following federal RCRA requirements for such containers.
5. Disposal of Laboratory Wastewater
Issue: Federal and some local agencies allow the disposal of some aqueous solutions resulting from laboratory operations where laboratory wastewater is less than 1% of the total waste water flow to the POTW. The Task Force recognizes the distinction between chemical wastes from the Laboratory Process Unit and laboratory rinsates from reusable glassware. How does the exemption from hazardous waste regulation for "wastewater resulting from laboratory operations" found at 22 CCR §66261.3 (a)(2)(iv)(E) apply to dilute aqueous solutions of listed hazardous wastes?
Current DTSC Interpretation: This practice is forbidden due to Appendix X (b) of Title 22, _§ 66261.126, whereby all laboratory wastes are "presumed to be hazardous wastes unless it is determined that the waste is not a hazardous waste pursuant to the procedures set forth in section 66262.11", and the prohibition against "disposing hazardous waste at an unauthorized point" (H&SC sec. 25189.5).
Recommendation: Utilize the federal RCRA exemption for "laboratory wastewater." Change Appendix X(b) of Title 22, § 66261.126 by deleting "laboratory wastes" from the listing.
This Health and Safety Code section was clearly passed into law to control illegal and midnight dumping, and not meant to prohibit discharge to sinks of very dilute solutions. The exemption was created at the Federal level, and adopted by California, for "mixtures of non-hazardous and laboratory wastewater that contain or may contain listed hazardous wastes" (46 Federal Register, 56582). Note that the exemption applies only to toxic wastes, and the annual flow of lab wastewater cannot exceed one percent of the flow into the POTW, or the discharge does not exceed one part-per-million concentration when measured at the headwaters of the facility. Local sewer regulations and limits restrict the contaminants that may be introduced into the sewer, and these regulations are protective of the environment. Appendix E discusses this issue in further detail.
6. Release Reporting For Hazardous Materials and Hazardous Wastes From Laboratories
Issue: If a small amount of a chemical is spilled in a lab and quickly cleaned up, is reporting required under the hazardous waste regulations?
Current Interpretation: As soon as the hazardous material spill occurs, it becomes a waste, and must be reported.
DTSC moderated this interpretation in the November 17, 1994 Task Force meeting. The stated position at that meeting was that the act of spilling a hazardous material alone did not result in a reportable hazardous waste release. If the material was cleaned up with no release to the environment, no report to DTSC is required.
Recommendation: Spill and release reporting should only be triggered by a release of hazardous material or waste which occurs within the laboratory when the spill:
Under the Laboratory Process Unit model the release reporting requirements apply to the "contingency plan" regulations applicable to the "facility", which means the areas where hazardous waste is treated, stored, or disposed.
Within the laboratory, employee exposures are regulated by Cal-OSHA which already has specific reporting requirements for exposures to hazardous materials, including hazardous waste materials. Minimization of overlapping regulations and jurisdictional areas will provide for better efficiency among agencies. Therefore, releases to the air within the laboratory should not automatically be considered releases to the environment. The Bay Area Air Quality Management District (BAAQMD) has embraced this exemption for their permiting process and will be publishing the new rule in June 1995, Regulation 2, Rule 1 -- "Laboratory Exemption Rule for Permiting". Laboratory exhausts are engineering controls intended to safely discharge small releases from a building. Typical uses within the laboratory, even with small spills, will not result in a significant discharge from the building exhaust system to the air. Therefore, the recommendation above is adequate to cover air discharges of concern.
7. Mixed Waste
Issue: Mixed radioactive and chemical waste is being managed in an appropriately licensed manner for decay. Does this count as "storage" under the hazardous waste regulations?
Current Interpretation: Mixed wastes are hazardous wastes, and subject to all the hazardous waste storage requirements, in addition to the California Department of Health Services or Nuclear Regulatory Agency requirements.
Recommendation: The Task Force strongly recommends that generator management and storage of low-level radioactive materials that also contain chemicals be regulated by one agency, namely the agency responsible for the control and use of radioactive materials.
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. This is a prime example of such occurrence. 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 an unnecessary waste of resources. Precedent for assignment of the responsibility for oversight of mixed waste to one agency already exists in the California Medical Waste Management Act whereby mixed chemical/biological waste is managed solely by the DTSC who has regulatory oversight of the chemical waste program.
The Task Force strongly recommends regulation of mixed low-level radioactive waste by the jurisdiction of the agency responsible for control and use of radioactive materials, namely the California Department of Health Services. This agency has the authority, within its existing licensing requirements, to adequately control the storage of low-level mixed wastes.
Until the recommended action is fully implemented, DTSC should utilize the enforcement policy adopted by US EPA (56 FR 42730 and 58 FR 18813), which acknowledges the lack of disposal options for mixed waste and that on-site storage for decay is the only available method for management of this waste.
8. Definition of "Onsite Facility" for Large Institutions and Affiliates
Issue: Management Memorandum #EO-93-031-MM establishes requirements for the
management of hazardous waste within a geographically contiguous large institution.
Current Interpretation: As long as the affiliates are on contiguous property, or on property connected by rights of way "controlled" by the institution, they are considered on-site. Transportation must occur within the confines of the campus, and the institution must assume full responsibility for the waste.
Recommendation: The Task Force supports the DTSC interpretation.
This concept should be extended to biotechnology companies, hospitals, clinics, and other laboratory business entities which operate a geographically contiguous facility. It is the geographic contiguity of these facilities, rather than the particular features of universities and government agencies, which is relevant to ensuring compliance with the hazardous waste regulatory requirements for "onsite" facilities.
The term "controlled" should be clarified to mean that the facility could close off access in an emergency in conjunction with local emergency providers, not necessarily that the institution has maintenance or other responsibility for the right-of-way.
Hazardous waste transported across or along roads or other rights of way within such a contiguous property is not considered to be transportation "in commerce" for purposes of the US DOT requirements. In other words, the right-of-way would be within the confines of the property owned by the institution.
9. Closed Containers
Issue: What constitutes a closed container of hazardous waste? (Management Memorandum # EO-93-020-MM)
Current DTSC Interpretation: All closing devices must be secured in such a way as to prevent any liquid or vapor from escaping the container. No vapors should be detected by smell, sight, or any monitoring equipment possessed by the inspector.
Recommendation: Containers would be considered "closed" if:
Arbitrary limits such as "smell" and "detected by any monitoring equipment" should be avoided as detection limits of individual olfactory senses and portable equipment are highly variable and some are extremely sensitive. These limits are rightfully the jurisdiction of other agencies, namely OSHA within the workplace and regional air boards for air emissions.
No additional hazardous waste requirements for closure would apply to containers which are part of the experimental process. The material is not a waste until it is removed from the laboratory process unit, unless the generator makes such a determination within the laboratory. Hazardous material requirements and regulatory oversight would continue to apply.
10. Training and Record Keeping
Issue: Is hazardous waste training required for laboratory personnel?
Current Interpretation: Annual training (including documentation of name of individual, job title, and duties) is required for all personnel at the institution who perform any waste activities unless they are exempt because they only manage waste in a satellite accumulation area (SAA). Under the current interpretations, they would not be exempt if the laboratory consists of more than one room and the waste from one room is maintained in the other room (Laboratory Satellite Accumulation Area model). Personnel shall also be exempt if their only activity is to generate the waste and they perform no other activities. Individuals outside of SAA's who perform such tasks as labeling containers, or pouring waste into a labeled container, or functioning on any emergency response team at the institution (building emergency coordinators, for example) must be trained.
Recommendation: Under the laboratory process unit interpretation, the qualified professional or technical staff is responsible for waste handling and management. The hazardous waste compliance training requirement would apply to the "technically qualified person(s)" and waste technicians, not necessarily all laboratory personnel.
The requirement for training applies to "facility personnel". The definition of this term, found in the regulations, states that these personnel must work at, or oversee work at the portion of the institution which is used for treating, storing, or disposing of hazardous waste or at a ninety (90) day storage area. To the extent that none of these activities take place in the lab, the lab personnel should be considered exempt from the hazardous waste training requirements. If a generator site decides to have regulatory determinations made by the bench scientists, then such training would be appropriate.
It is important to note that other training requirements do already apply, such as the OSHA laboratory standard and the Hazard Communication Standard. See Appendix D for a full discussion of the many and various regulations that already apply to the laboratory, and which provide for adequate regulatory oversight of laboratory operations. 11. Use of Accredited Laboratories For Analysis
Issue: Analysis by an accredited lab is the only means DTSC accepts for the determination and identification of an unknown chemical material (22 CCR §66262.11 and Fact Sheet # 10)
Recommendation: "Unknowns" identified for disposal within lab packs can be identified by approved analysis on-site, providing the requirements below are met.
Generators are entitled to use "generator knowledge" to make on-site waste determination. Laboratory facilities are uniquely qualified to perform analysis of wastes of unknown composition as the "generating" site.
Many unknowns are being "disposed" via accredited labs due to the small quantities of the material that still require analysis prior to disposal. (The total amount of the material is used up in the analysis.) Laboratories have highly qualified analysts capable of providing appropriate analyses. These labs can demonstrate analytical capabilities by providing the following:
These requirements are similar to those which the FDA accepts for analytical testing of products for injection into humans.
12. Regulatory Interpretations and Distribution
Issue: Interpretations of statutes and regulations relative to laboratories are often contradictory and are not widely disseminated. Considerable inconsistency in enforcement actions and compliance exists.
Recommendation: Because it is likely that laboratory regulations will elvolve and emerge DTSC and the laboratory community should develop a mechanism for uniform distribution and dissemination of DTSC information. DTSC should ensure a draft Management Memorandum implementing the recommendations of this Task Force and consolidating regulatory interpretations of hazardous waste management at laboratories is issued for general distribution and comment. Following a reasonable review period, the Memorandum should then be consistently enforced statewide by both state and local agencies.
Allowing for this era of enlightened, reasonable and knowledgeable interpretations of regulations and statutes, a proactive approach to clarity and consistency of enforcement would better serve the regulated and the regulators.
13. Certain Medical Wastes Classified as Hazardous Waste
Issue: Medical Wastes with insignificant amounts of chemical additives must be managed as regulated hazardous waste.
Current Interpretation: Some hospital laboratories have been informed by enforcement officials that the addition of a small amount of additive to stool and urine specimens (for the purpose of making them more easily evaluated by microscope or by mechanical analyzer) may cause the specimens to be classified as "regulated hazardous waste."
Recommendation: Medical wastes consisting of stool, urine, blood, tissue, or other human or animal specimens that would be deemed regulated 'hazardous waste' under Chapter 6.5 only because they contain an additive for the purpose of aiding evaluation or diagnosis should be managed as medical waste in accordance with the applicable provisions of the Medical Waste Management Act, should be disposed of in accordance with Section 25090(a), and should not be subject to Chapter 6.5.
As a practical matter, and as a human health issue, certain medical wastes should be managed as medical wastes even when they contain minute amounts of chemical additives. It is better to treat such wastes as medical wastes (which can be disposed of under the Medical Waste Management Act) rather than as a hazardous waste which would need to be collected. Recognizing this issue, the legislature amended Section 25020.5 of the Health & Safety Code in 1992 to specify that human surgery specimens or tissues that have been fixed in formaldehyde or other fixatives should be regulated as medical waste rather than as hazardous waste. Unfortunately, further experience indicates that this legislation was not broad enough and the medical wastes, as identified above, should be exempt from the hazardous waste provisions of Title 22.
Adoption of performance based standards like the OSHA laboratory standard, or ISO 14000 laboratory environmental quality management system, hold considerable promise as alternate compliance models. New legislation and regulations would be needed, however. Due to the limited time frame of the Task Force's review, and the belief that substantial and significant improvements for regulation of laboratory waste management can be accomplished through implementation of the above recommendations, detailed requirements of such a project have not been developed. The Task Force does recommend that the agency consider evaluation of development of such a standard as a long term resolution to this issue, and is willing to participate on such an activity in the future.
The Task Force endorses the goals prescribed by DTSC and believes the recommendations set forth in this document embody the spirit of an enlightened approach to regulating laboratories through knowledgeable interpretation of statutes and regulations and recommendations that focus on environmental protection performance without unnecessary and undue burden on laboratories and the research enterprise within California.
By embracing the "laboratory processing unit" interpretation and implementing the other recommendations in a expeditious manner, research, education and private sector companies will be better positioned to continue to enhance the economy of the state and preserve environmental equality.
The Task Force members appreciate this opportunity to interact with DTSC and look forward to continuing a productive working relationship in streamlining and, when appropriate, simplifying the existing regulations while ensuring the common goal of environmental protection and public safety in the management of hazardous waste from laboratory facilities.
A. Laboratory Regulatory Reform Task Force Membership List
B. GUIRR Report (August 1994)
C. Laboratory Process Unit Model Description and Schematic
D. Environmental Health and Safety Standards Currently Required in Laboratories
E. Regulatory and Domestic Sewage Exclusion Sub-group Report (Chairman: Mark Zemelman - Kaiser Permanente)
F. DTSC Fact Sheet -- Handling of Hazardous Waste at Laboratories (10/6/94)