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Department Of Toxic Substances Control's Response To "Recommendations Of The Laboratory Regulatory Reform Task Force" Response To Issues 1 and 2.
Introduction
The Director of the Department of Toxic Substances Control (DTSC) created the Laboratory Regulatory Reform Task Force (Reform Task Force) in November 1994 to recommend improvements in the regulation of California laboratories. DTSC invited representatives from diverse organizations, including public and private universities, biotechnology industry, commercial testing laboratories, government laboratories and others. DTSC staff from the Hazardous Waste Management Program and staff from the Hazardous Materials Laboratory participated in the Reform Task Force meetings, as well as related meetings of the Government-University-Industry Research Round Table (GUIRR), which was sponsored by the National Academy of Sciences.
The Reform Task Force issued its report: Recommendations of the Laboratory Regulatory Reform Task Force in June 1995. DTSC had two subsequent meetings, one with a subgroup of the Reform Task Force and another with a group of laboratories who support the recommendations of the Reform Task Force. Information received during these meetings or in a subsequent document was considered prior to finalizing this response.
In preparing this response to the Reform Task Force, DTSC relied on the newly published version of Prudent Practices in the Laboratory (Prudent Practices) which was published by the National Academy of Sciences. Prudent Practices was prepared by a committee representing industry, government, and academia in order to provide a guide for safe laboratory practices and to influence the drafting of regulations. It is important to note that the Reform Task Force members have consistently supported the concepts and recommendations contained in Prudent Practices.
Prudent Practices in the Laboratory, Handling and Disposal of Chemicals. Committee on Prudent Practices for Handling, Storage, and Disposal of Chemicals in Laboratories, National Research Council, National Academy Press, Washington, D.C., 1995.
In addition, DTSC consulted with the U.S. Environmental Protection Agency (U.S. EPA), Region IX, on issues of consistency with federal regulations, with the California Occupational Safety and Health Administration (Cal/OSHA) regarding applicability of their laboratory standards, and with other agencies regarding issues under their jurisdiction. DTSC's response is generally consistent with the regulatory interpretations and actions taken by U.S. EPA and the other agencies that were consulted with.
The Reform Task Force included both recommendations for immediate implementation and recommendations for future study. The response to the recommendations uses the same format. As discussed under individual responses, some of the issues are already included in DTSC's ongoing Regulatory Structure Update (RSU).
This response to the Reform Task Force report and the response to issues 1, 2, and 10 due September 10, 1996 will later be incorporated into a DTSC Management Memo, which will be available on the California Environmental Protection Agency (Cal/EPA) ACCESS bulletin board as well as its worldwide web site: http://www.calepa.cahwnet.gov. Comments will be accepted on the Management Memo for 30 days, after which the comments will be reviewed by DTSC and the Management Memo will be revised as necessary and become final DTSC policy. After the final policy is established and distributed, DTSC will propose regulations, where necessary, to incorporate these responses into regulations.
Response to Introductory Comments
A statement in the introductory portion of the report, Recommendations of the Laboratory Regulatory Reform Task Force, requires comment. This report (page 2) asserts that DTSC has treated universities that were following the same management practices differently, approving certain practices at one university and not at another. Not withstanding the Reform Task Force's comment, DTSC believes that consistency and certainty of enforcement is the hallmark of good government. DTSC has always endeavored to follow these principles and will continue to do so.
Response to Recommendations
DTSC's latitude in making regulatory or statutory changes with regard to this subject is limited by DTSC's federal Resource Conservation and Recovery Act (RCRA) authorization. DTSC must be at least as stringent as U.S. EPA in its interpretation and implementation of these regulations.
ISSUES
1. The Laboratory Process; and
2. Regulatory Waste Determination
These two issues are closely related and difficult to respond to separately. We have taken the liberty of combining and rephrasing these two issues and responding to them as one issue.
Rephrased Issue: Should laboratory waste be regulated as hazardous waste before it leaves the laboratory?
Task Force Interpretation of the Existing DTSC Regulations: The Reform Task Force believes that DTSC considers a material a hazardous waste before an experiment is finished or before a material could be identified for reuse or recycling. It is the Reform Task Forceís understanding that DTSC requires each laboratory worker/researcher to make a hazardous waste determination at the generation point, and does not allow the overall operator of the generator site to make the determination.
DTSC Response to the Task Force Interpretation: A material is presumed to become a waste in a laboratory and therefore, would require labeling and proper management when:
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(The earliest of these dates is the accumulation start date.) However, the researcher, lab supervisor, safety officer, or other knowledgeable personnel can rebut this presumption through knowledge that the waste is non-hazardous, another use for the material is known, testing, or to correct an error. The presumption can be rebutted at the time of generation or at a later time as a result of new information. In the absence of this rebuttal, the waste must be managed as hazardous waste. Task Force Recommendation: The Reform Task Force suggests that DTSC adopt the concept of the "laboratory process unit" (LPU). The LPU is defined as a room or group of laboratory rooms under the control of a supervisor or principal investigator. The LPU would be considered analogous to the "manufacturing process unit" described in Title 40, Code of Federal Regulations (40 CFR) 261.4 (c). Therefore, hazardous wastes would not be regulated until after they are removed from the LPU, i.e. from the laboratory. The Reform Task Force also recommends that designated technically qualified facility personnel should make the regulatory waste determination after the waste is removed from the laboratory. DTSC Response to Task Force Recommendation: While the LPU concept may be less burdensome for laboratories, it would eliminate the responsible regulatory agencyís ability to conduct inspections necessary to verify hazardous water handling commensurate with protection of all personnel and the environment. Whether standards are prescriptive or performance-based, this verification of compliance is an essential element. One of the basic elements of the LPU is that a determination of whether a material is a waste or a product would not be made until after the material in question had left the LPU. Based on the description given by the Reform Task Force, an operator inside of an LPU would be free to use, reuse, treat, store or dispose of any and all wastes (including those which meet hazardous waste criteria) within the LPU without hazardous waste regulatory oversight. It has been DTSC's experience that inadequate waste labeling often leads to storage of incompatible wastes next to each other, storage of wastes for extremely long time periods and the improper disposal of those wastes. All of these actions have lead to increased risk or actual injuries. DTSC is very much aware of the burden that numerous inspections by many different agencies places on businesses in California. The problem is considerably more serious when these agenciesí activities appear to be overlapping or duplicative. For the majority of laboratories in California (those without full or standardized treatment or storage permits), current implementation of the Certified Unified Program Agency (CUPA) at the local level will help reduce overlap by consolidating six existing regulatory programs within one agency. These six programs include the Risk Management Prevention Plan; the Hazardous Materials Business Plan; Hazardous Wastage Generation and Tiered Permitting Requirements; Underground Storage Tank Program; and the Above Ground Storage Tank Reporting Requirements in Article 80 of the Uniform Fire Code. A major goal of the CUPA program is to consolidate the surveillance requirements of these programs into one inspection. Beyond this consolidation, DTSC, through its Regulatory Structure Update Project (RSU), is aggressively reviewing current State-only (beyond the Resource Conservation and Recovery Act (RCRA)) regulations with a focus on duplication of requirements imposed by other agencies. Through the Reform Task For effort DTSC is equally committed to elimination of duplicative burdens imposed to the laboratory community. The Reform Task Forceís belief that the California Occupational Safety and Health Administration (Cal/OSHA) may adequately regulate waste handling activities within the LPU is not completely accurate. Cal/OSHA regulatory authority applies only to employees rather than all lab personnel, and the requirements do not extend to protection of the environment. Cal/OSHA primarily responds to complaints or incident reports as opposed to conducting routine inspections of laboratory operations. In discussions with Cal/OSHA, they have advised DTSC that they have not conducted any inspections of laboratories within the last three years, that were not incident or complaint-driven. Cal/OSHA's laboratory standards, while comprehensive in scope, do not include specific hazardous waste management requirements, except in an appendix that is voluntary. Additionally, Cal/OSHA regulations contain some exclusions specific to laboratories and Cal/OSHA's regulations are not designed to address the proper storage, treatment, and disposal of hazardous wastes, except in the context of worker protection. One example of an exclusion is that federal laboratories are exempt from Cal/OSHA standards and are only required to follow the less stringent federal OSHA regulations. The discussions between Cal/OSHA and DTSC on laboratory issues have provided both agencies with a better understanding of the scope and application of the other agency's regulatory responsibilities. This will enable DTSC to ensure that the hazardous waste regulations do not overlap existing Cal/OSHA requirements for the protection of worker safety, but provide only the elements necessary for safe handling of hazardous waste. DTSC has committed to continue to work with Cal/OSHA to develop a seamless regulatory structure that does not duplicate requirements and to provide a single Cal/OSHA-DTSC guidance document to assist laboratories with compliance issues. Another issue central to the applicability of an LPU-type determination is federal laws, regulations, and policies as it relates to laboratory waste management. A synopsis of existing federal regulations and interpretations is discussed in Enclosure A. This synopsis was prepared in discussion with the U.S. Environmental Protection Agency (U.S. EPA) and further supported by a recent U.S. EPA letter (Enclosure B). Federal regulations specify that at the moment of generation, a material becomes a waste if the operator of the process generating the waste has no further use for it and the facility cannot provide for the recycling or reuse of that material in a timely manner. The LPU approach would be less stringent than the RCRA regulations and would require U.S. EPA to seek changes in federal laws and regulations. Based on the reasoning described in the preceding paragraphs, DTSC cannot accept the LPU concept. However, DTSC recognizes the need for regulatory reform in this area and is proposing to modify existing regulations to allow labeling of waste containers in the laboratory at the point of waste generation with only the following information: |
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It is important to note that the Reform Task Force agrees with the DTSC proposal to limit laboratory accumulation time to one year. DTSC believes this agreement translates into a need for the identification of an accumulation date on each waste label. The waste would still be subject to the accumulation time, container requirements, and quantity limits as identified below: |
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Examples of potential performance standards are: |
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