9
Governmental Regulation of Laboratories

   

9.A INTRODUCTION

 

198

   

9.B RISK AND REGULATION

 

198

   

9.C THE OSHA LABORATORY STANDARD: OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS IN LABORATORIES

 

202

   

9.C.1 The Chemical Hygiene Plan

 

202

   

9.C.2 Relation of the OSHA Laboratory Standard to Other OSHA Standards

 

203

   

9.C.3 PELs and TLVs

 

203

   

9.C.4 Particularly Hazardous Substances

 

203

   

9.C.5 Protection of Other Personnel in Laboratories

 

204

   

9.C.6 Federal Versus State Regulations

 

204

   

9.C.7 Laboratory Standard Versus Hazard Communication Standard

 

204

   

9.D THE RESOURCE CONSERVATION AND RECOVERY ACT

 

205

   

9.D.1 Definition of a Generator

 

205

   

9.D.2 Definition of Hazardous Waste

 

206

   

9.D.3 Accumulation Times and Amounts

 

206

   

9.D.4 Satellite Accumulation

 

206

   

9.D.5 Drain Disposal of Hazardous Waste

 

207

   

9.D.6 Empty Containers

 

207

   

9.D.7 Land Disposal of Hazardous Waste

 

208

   

9.D.8 In-laboratory Treatment

 

208

   

9.D.9 Waste Minimization Under RCRA

 

208

   

9.D.10 Transportation of Chemicals and Hazardous Waste

 

209

   

9.D.11 Underground Storage Tanks

 

209

   

9.E THE CLEAN AIR ACT

 

209

   

9.F SARA TITLE III, COMMUNITY RIGHT-TO-KNOW AND EMERGENCY NOTIFICATION AND RESPONSE

 

210

   

9.G THE TOXIC SUBSTANCES CONTROL ACT

 

210

   

9.G.1 Research and Development (R&D) Exemption from the Premanufacture Notification (PMN)

 

210

   

9.G.2 Record-keeping Requirements for Significant Adverse Reaction Allegations—TSCA 8(c)

 

211

   

9.G.3 Regulations Covering Polychlorinated Biphenyls (PCBs)

 

212

   

9.H REGULATION OF LABORATORY DESIGN AND CONSTRUCTION

 

212



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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals 9 Governmental Regulation of Laboratories     9.A INTRODUCTION   198     9.B RISK AND REGULATION   198     9.C THE OSHA LABORATORY STANDARD: OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS IN LABORATORIES   202     9.C.1 The Chemical Hygiene Plan   202     9.C.2 Relation of the OSHA Laboratory Standard to Other OSHA Standards   203     9.C.3 PELs and TLVs   203     9.C.4 Particularly Hazardous Substances   203     9.C.5 Protection of Other Personnel in Laboratories   204     9.C.6 Federal Versus State Regulations   204     9.C.7 Laboratory Standard Versus Hazard Communication Standard   204     9.D THE RESOURCE CONSERVATION AND RECOVERY ACT   205     9.D.1 Definition of a Generator   205     9.D.2 Definition of Hazardous Waste   206     9.D.3 Accumulation Times and Amounts   206     9.D.4 Satellite Accumulation   206     9.D.5 Drain Disposal of Hazardous Waste   207     9.D.6 Empty Containers   207     9.D.7 Land Disposal of Hazardous Waste   208     9.D.8 In-laboratory Treatment   208     9.D.9 Waste Minimization Under RCRA   208     9.D.10 Transportation of Chemicals and Hazardous Waste   209     9.D.11 Underground Storage Tanks   209     9.E THE CLEAN AIR ACT   209     9.F SARA TITLE III, COMMUNITY RIGHT-TO-KNOW AND EMERGENCY NOTIFICATION AND RESPONSE   210     9.G THE TOXIC SUBSTANCES CONTROL ACT   210     9.G.1 Research and Development (R&D) Exemption from the Premanufacture Notification (PMN)   210     9.G.2 Record-keeping Requirements for Significant Adverse Reaction Allegations—TSCA 8(c)   211     9.G.3 Regulations Covering Polychlorinated Biphenyls (PCBs)   212     9.H REGULATION OF LABORATORY DESIGN AND CONSTRUCTION   212

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals 9.A INTRODUCTION Recent years have seen a proliferation in the number of laws, regulations, and ordinances, federal, state, and local, that affect laboratories. This body of law is vast, complex, and intricate in its details and interrelationships. Both the law and its application vary from state to state, among federal regulatory agency regional offices, and among local jurisdictions. The individual researcher or laboratory worker cannot possibly be familiar with all of these regulations, but it is important that there be a strong institutional capacity, usually in a specialized office of environmental health and safety professionals, that is familiar with the details of these rules and can act as a resource for the researcher. In those smaller institutions that may not have such a specialized office, a researcher or an assigned individual, perhaps from the chemistry department, should seek advice directly from the regulatory agencies, from knowledgeable environmental health and safety professionals from other institutions, or from private environmental health and safety professionals and consultants. In addition, all researchers should be familiar with the principal provisions and concepts of the most important laws and regulations that affect laboratories across the country. The two most important are the Occupational Safety and Health Administration's regulation, Occupational Exposure to Hazardous Chemicals in Laboratories (the OSHA Laboratory Standard) and the Resource Conservation and Recovery Act (RCRA), under which the Environmental Protection Agency (EPA) regulates hazardous waste. Because of its importance, the text of the OSHA Laboratory Standard is reprinted in Appendix A. Researchers, laboratory workers, and, in particular, laboratory managers and supervisors should read and understand these regulations. 9.B RISK AND REGULATION Within the scientific research community, ambivalence about environmental health and safety regulations has raised much attention. The ethical conduct of science encourages excellence in scientific discovery while upholding societal values. Not surprisingly, highly trained chemists and other scientists, while fully supporting prudent and safe practices in the laboratory, sometimes feel that regulatory requirements do not distinguish scientifically among the varying levels of risk presented by some substances and procedures. To some extent this is true, but carried to an extreme, this perception can preclude a sufficient understanding of the rationale and realities that underlie environmental health and safety laws and regulations. The basic laws-the Occupational Safety and Health Act, governing worker safety and health, the Resource Conservation and Recovery Act, governing the safe generation, storage, transport, and disposal of hazardous chemical waste, and the Clean Air Act and Federal Water Pollution Control Act, protecting public health and the environment-have been conceived soundly. These and other laws reflect congressional, state, and local legislative concern about the problems they address and generally enjoy strong public support. These and other relevant laws, along with their associated regulations, are listed in Table 9.1. The research chemist might ask, ''Why do I have to label all the chemicals in my laboratory? I know what's in those bottles." "Why can't I pour this chemical down the drain? It's such a small quantity that it will be diluted to harmlessness." "Why must I fill out detailed labels for the waste containers in my laboratory? Who needs all this paperwork?" and so forth. The regulator would answer, "Yes, but if your chemicals aren't labeled, new workers in the laboratory won't know what is in those containers. If they don't know the contents, how can they properly use, store, or dispose of the unlabeled chemicals? Also, what happens if there's a fire or other emergency? The emergency crew responding won't know what's in your laboratory." Or, "If everyone poured just a little bit of that chemical down the drain, it could, cumulatively, seriously degrade water quality in sensitive rivers, lakes, or streams." This debate is complicated by the fact that it is a virtual impossibility for environmental health and safety regulators to weigh every risk precisely. To attempt chemical-by-chemical regulation of the thousands of known, and unknown, chemicals would be so onerous and time-consuming as to leave many serious hazards unregulated. Consequently, the regulators have tried to strike a balance, regulating by class of risk, for example, ignitability, corrosivity, reactivity, and toxicity, and relying on employers to exercise reason and prudence in caring for the safety of their employees, as in OSHA's "General Duty" clause and the Hazard Communication Standard and the Laboratory Standard. Those managing and working in laboratories should also recognize that violation of environmental health and safety laws and regulations not only may pose unnecessary risks to those in the laboratory and the surrounding community, but also can result in serious collateral consequences-imposition of civil penalties (fines of up to $25,000 per day per violation), as well

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals TABLE 9.1 Federal Laws and Regulations Affecting Laboratories Law / Regulation Citation Purpose Comments Occupational Safety and Health Act (OSHA) 29 USC 651 et seq. Worker protection   Occupational Exposure to Hazardous Chemicals in Laboratories (Laboratory Standard) 29 CFR 1910.1450 Laboratory worker protection from chemical use   Hazard Communication Standard 29 CFR 1910.1200 General worker protection from chemical use   Occupational Exposure to Blood borne Pathogens 29 CFR 1910.1030 Worker protection from exposure to blood borne pathogens   Air Contaminants 29 CFR 1910.1000-1050 Standards for exposure to hazardous chemicals   Hazardous Waste Operations and Emergency Response(HAZWOPER) 29 CFR 1910.120 and 40 CFR 311 Worker protection during hazardous waste cleanup Applies to state and local government employees not covered by OSHA Hazardous Materials 29 CFR 1910.101-111 Protection against hazards of compressed gases, flammable and combustible liquids, explosives, anhydrous ammonia See also Uniform Fire Code(UFC) and National Fire Protection Association (NFPA) standards Personal Protective Equipment 29 CFR 1910.132-138 Head, hand, foot, eye, face, and respiratory tract protection See also American National Standards Institute (ANSI) standards Medical Services and First Aid 29 CFR 1910.151 Provision of medical services, first aid equipment, and facilities for quick drenching and flushing of eyes   Control of Hazardous Energy(Lock out/Tag out) 29 CFR 1910.147 Worker protection from electrical and other stored energy hazards   Machinery and Machine Guarding 29 CFR 1910.211-219 Worker protection from mechanical hazards   Ionizing Radiation 29 CFR 1910.96 Worker protection from radiation See also Atomic Energy Act General Duty Clause 29 USC 654 5(a) and (b) Assurance of workplace free from recognized hazards that are causing or likely to cause serious physical harm   Resource Conservation and Recovery Act (RCRA) 42 USC 6901 et seq. Protection of human health and environment   Hazardous Waste Management 40 CFR 260-272 "Cradle-to-grave" control of chemical waste   Underground Storage Tanks 40 CFR 280 Protection against groundwater and soil contamination  

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals Law / Regulation Citation Purpose Comments Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) 42 USC 9601 et seq. Remediation of past chemical disposal sites and assignment of liability Also known as "Superfund" law Superfund Amendments and Reauthorization Act (SARA) 42 USC 9601 et seq. 42 USC 11000 et seq. Planning for emergencies and reporting of hazardous materials Title III also known as Community Right-to-Know Act National Contingency Plan 40 CFR 300-30 Cleanup requirements for spills and disposal sites   Emergency Planning and Notification 40 CFR 355 Requirements for reporting of extremely hazardous materials and unplanned releases Applies to all chemical users Hazardous Chemical Reporting: Community Right-to-Know Act(SARA 311-312) 40 CFR 370 Requirements for reporting of hazardous chemicals in use Exempts hazardous chemicals laboratories(states may vary)used in research Toxic Chemical Release Reporting (SARA 313) 40 CFR 372 Requirements for reporting chemical releases of Applies only to manufacturing facilities (states may vary) Toxic Substances Control Act(TSCA) 15 USC 2601 et seq. Protection of human health and the environment by requiring testing and necessary restrictions on use of certain chemical substances Collection and development of information on chemicals Reporting and Record-keeping Requirements 40 CFR 704 One provision exempts users of small quantities solely for research and development(R&D) Must follow R&D exemption requirements Significant Adverse Reaction 40 CFR 717 Record of new allegation that chemical substance or mixture caused significant adverse effect for health or the environment TSCA 8(c) Premanufacture Notification(PMN) 40 CFR 720 Premanufacture notification(PMN) for chemical not on TSCA Inventory Requires notification of EPA before manufacture or import of new chemical substance Technically Qualified Individual(TQI) 40 CFR 720.3(ee) Definition of technically qualified individual (TQI) by background, understanding of risks, responsibilities, and legal requirements Follow TQI requirements with R&D TSCA Exemption for Research and Development (R&D) 40 CFR 720.36 Exemption for R&D from PMN if chemical substance not on TSCA Inventory is manufactured or imported only in small quantities solely for R&D Follow R&D exemption requirements including labeling and MSDS information Polychlorinated Biphenyls(PCBs) 40 CFR 761 Prohibitions against PCBs in manufacturing, processing, distribution in commerce, and use prohibitions Permits certain limited laboratory use of PCBs

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals Law/Regulation Citation Purpose Comments Clean Air Act (CAA) 42 USC 7401 et seq. Protection of air quality and human health   Clean Air Act Amendments of 1990 (CAAA) 42 USC 7409 et seq. Expansion of air quality protection Requires development of specific rules for laboratories National Emission Standards for Hazardous Air Pollutants(NESHAP) 40 CFR 70 Control of air pollutant emissions   Montreal Protocol: Protection of Stratospheric Ozone 40 CFR 82 Control of emission of ozone-depleting compounds Severely limits use of certain chlorofluorocarbons Federal Water Pollution Control Act (FWPCA) 33 USC 1251 et seq. Improvement and protection of water quality   Criteria and Standards for the National Pollutant Discharge Elimination System (NPDES) 40 CFR 125 Control of discharge to public waters   General Pretreatment Regulations for Existing and New Sources of Pollution 40 CFR 403 Control of discharge of pollutants to public treatment works Implemented by local sewer authorities Hazardous Materials Transportation Act (HMTA) 49 USC 1801 et seq. Control of movement of hazardous materials   Hazardous Material Regulations 49 CFR 100-199 Regulation of packaging, labeling, placarding, and transporting   Hazardous Materials Training Requirements 49 CFR 172.700-704 Assurance of training for all persons involved in transportation of hazardous materials Also known as HM126F Atomic Energy Act (AEA) Energy Reorganization Act(ERA) 42 USC 2073 et seq. 42 USC 5841 et seq. Establish standards for protection against radiation hazards See also OSHA, Ionizing Radiation Standards for Protection Against Radiation; Licenses 10 CFR 20 10 CFR 30-35 Establish exposure limits and license conditions Rules promulgated by Nuclear Regulatory Commission National Environmental Policy Act (NEPA) 42 USC 4321 et seq. Ensure consideration of all environmental effects   Requirements of the Council on Environmental Quality 40 CFR 6 and 1506 Indicate requirements for Environmental Impact Statement (EIS)   as criminal penalties. Perhaps of general importance, violations can erode community confidence in an institution's seriousness of purpose in safeguarding the environment and complying with the law. It should be recognized that "prudent practice" involves not only scientific prudence but also prudent behavior in terms of the risks of violation of law or regulation, that is, the risk of adverse publicity for the institution and the risk of damaging the important trust and support of the community for the overall academic enterprise. It is also prudent for institutions that handle chemicals in laboratories to participate in the regulatory process so that regulators will understand the impact that proposed rules can have on the laboratory environ-

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals ment. Because environmental regulations, particularly RCRA regulations, have not yet, in general, recognized the unique nature of the laboratory setting, some rules may be unnecessarily onerous for laboratories, without producing the expected increase in environmental protection. The best way to influence the regulatory process is through dialogue with the regulators. This dialogue, particularly at the state and local levels, can take place directly or in collaboration with the institution's environmental health and safety or governmental relations office. Also, professional associations, such as the American Chemical Society, the American Industrial Hygiene Association, the American Conference of Governmental Industrial Hygienists, and the American Institute of Chemical Engineers, as well as trade associations such as the Chemical Manufacturers Association, regularly comment on proposed regulations, especially proposed federal regulations (which, by law, require solicitation of comment from interested parties). Participation in the regulatory process through such groups is encouraged. A brief description of the federal legislative and regulatory processes may be helpful. Laws are a product of legislative activity. Legislation is usually proposed by senators and representatives to achieve a desired result, for example, improved employee safety or environmental protection. Proposed laws are often known by their Senate or House file numbers, for example, S.xxx or H.R.xxx. Copies of proposed laws can be obtained, even at this early stage in the process, by requesting them from local offices of House or Senate members. Sponsors of proposed legislation are open to comment from the public. Once a law is passed, it is known by its Public Law number, for example, P.L. 94-580, Resource Conservation and Recovery Act (RCRA). It is published in the United States Code and is referenced by volume and chapter number; 42 USC 6901 et seq. is the citation for RCRA. When a law is passed, it is assigned to an administrative unit (agency or department) for development of rules and regulations that will implement the purpose of the legislation. The two major agencies involved in regulation of chemicals are the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA). Proposed regulations are published in the Federal Register, a daily publication of federal agency activities. A public comment period and perhaps public hearings are specified, during which all affected parties have an opportunity to present their support for or concerns with the regulations as proposed. This is the second significant opportunity for involvement in the regulatory process. Final rules are published in the Federal Register and in the Code of Federal Regulations (CFR), which is updated annually to include all changes during the previous year. Rules in the CFR are referenced by title and part number; 40 CFR 260-272 is the citation for RCRA's hazardous waste rules. 9.C THE OSHA LABORATORY STANDARD: OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS IN LABORATORIES Beginning in the early 1970s, groups and individuals representing laboratories contended that the then existing OSHA standards, designed for exposure conditions in an industrial production setting, were inappropriate for the very different exposure conditions in laboratories. As a result of these concerns, OSHA in 1981 undertook the development of a special regulatory regime for laboratories. The Laboratory Standard, promulgated in 1990, was the result (see Appendix A). In its Laboratory Standard, OSHA refers to the National Research Council's (1981) Prudent Practices for Handling Hazardous Chemicals in Laboratories as "nonmandatory ... guidance to assist employers in the development of the Chemical Hygiene Plan." It is anticipated that the present edition, Prudent Practices in the Laboratory: Handling and Disposal of Chemicals, will likewise be referenced. 9.C.1 The Chemical Hygiene Plan The centerpiece of the Laboratory Standard is the Chemical Hygiene Plan. This is a written plan developed by the employer (e.g., university or research organization) and has the following major elements: employee information and training about the hazards of chemicals in the work area, including how to detect their presence or release, work practices and how to use protective equipment, and emergency response procedures; the circumstances under which a particular laboratory operation requires prior approval from the employer; standard operating procedures for work with hazardous chemicals; criteria for use of control measures, such as engineering controls or personal protection equipment; measures to ensure proper operation of fume hoods and other protective equipment; provisions for additional employee protection for work with "select carcinogens" (as defined in the Laboratory Standard) and for reproductive toxins or substances that have a high degree of acute toxicity; provisions for medical consultations and examinations for employees; and designation of a chemical hygiene officer.

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals In many large institutions, the environmental health and safety department has developed a generic Chemical Hygiene Plan, but the plan must be modified to include detailed protections that are specific to each laboratory and its workers. This approach allows considerable flexibility in achieving the performance-based goals of the Laboratory Standard. Model Chemical Hygiene Plans are available from the OSHA consultation service, from the American Chemical Society, and from some professional associations or commercial sources. 9.C.2 Relation of the OSHA Laboratory Standard to Other OSHA Standards Several points about the OSHA Laboratory Standard deserve special mention. The intention of the standard is to supersede existing OSHA health standards, but other OSHA rules on topics not specifically addressed in the standard remain applicable. The so-called "general duty" clause of the Occupational Safety and Health Act, which requires an employer to "furnish to each of his employees ... a place of employment ... free from recognized hazards that are likely to cause death or serious physical harm ... " and requires an employee to "comply with occupational safety and health standards and all rules ... issued pursuant to this chapter which are applicable to his own actions and conduct" continues to be applicable and, indeed, is one of the most commonly cited sections in cases of alleged OSHA violations. Other OSHA standards relating to possible eye or skin contact must continue to be observed. There are dozens of chemicals in this category. They are listed in 29 CFR 1910 as well as in specific standards following Section 1910.1000, such as the vinyl chloride standard, 29 CFR 1910.1017, which prohibits direct contact with liquid vinyl chloride. Other OSHA standards setting forth permissible exposure limits (PELs) apply to the extent that they require limiting exposures to below the PEL and, where the PEL or "action level" is routinely exceeded, the Laboratory Standard's provisions require exposure monitoring and medical surveillance. The requirements for exposure monitoring and medical surveillance are found in Appendix A, sections (d) and (g) of the Laboratory Standard. 9.C.3 PELs and TLVs OSHA's permissible exposure limits were directly adopted, in 1970, from the similar list of threshold limit values (TLVs), a nonregulatory consensus document prepared by the American Conference of Governmental Industrial Hygienists (ACGIH). Quoting the TLV booklet (ACGIH, 1994), "Threshold Limit Values (TLVs) refer to airborne concentrations of substances and represent conditions under which it is believed that nearly all workers may be repeatedly exposed day after day without adverse health affects." TLVs are average concentrations over a normal 8-hour work day and a 40-hour work week. The existence of a "time-weighted average (TWA) exposure" approach to control of airborne contaminants indicates that exposures may be somewhat higher or lower than the average at various times of the day, which is typical of work with chemicals. ACGIH also recommends, for some compounds, a short-term exposure limit (STEL), which establishes a safe exposure limit of no more than four 15-minute periods a day. STELs are published only for compounds where toxic effects have been reported from high short-term exposures in either humans or animals. STELs typically are no more than 25 to 200% above the associated TLV. Some compounds have a "C" preceding the numerical TLV designation. This indicates that the TLV is a ceiling level concentration that should not be exceeded during any part of the working exposure. Ceiling limits have generally been applied to compounds that are fast acting. For compounds that include neither a STEL nor a C notation, a limit on the upper level of exposure should still be imposed. According to the TLV booklet, "Excursions in worker exposure levels may exceed 3 times the TLV-TWA for no more than a total of 30 minutes during a work day, and under no circumstances should they exceed 5 times the TLV-TWA, provided that the TLV-TWA is not exceeded." The "action level" is an OSHA regulatory term occurring in a few substance-specific regulations. It is an airborne concentration (lower than the associated PEL) that, when exceeded, requires certain activities, such as exposure monitoring or medical surveillance. If the researcher is working with one of the listed substances, it is important to understand when air monitoring and/or medical surveillance are required. 9.C.4 Particularly Hazardous Substances There are special provisions in the Laboratory Standard regarding work with "particularly hazardous substances," a term that includes "select carcinogens," "reproductive toxins," and "substances with a high degree of acute toxicity.'' A select carcinogen is defined in the standard as any substance (1) regulated by OSHA as a carcinogen, (2) listed as "known to be a carcinogen" in the Annual Report on Carcinogens published by the National Toxicology Program (NTP), (3) listed under Group 1 ("carcinogenic to humans") by the International Agency for Research on Cancer (IARC) Monographs, or (4) in certain cases, listed in either Group

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals 2A or 2B by IARC or under the category "reasonably anticipated to be carcinogens" by NTP. A category (4) substance is considered a select carcinogen only if it causes statistically significant tumor incidence in experimental animals in accordance with any of the following criteria: (1) after inhalation exposure of 6 to 7 hours per day, 5 days per week, for a significant portion of a lifetime to dosages of less than 10 mg/ m3; (2) after repeated skin application of less than 300 mg/kg of body weight per week; or (3) after oral dosages of less than 50 mg/kg of body weight per day. "Reproductive toxins" are defined as those chemicals that affect reproductive capabilities, including chromosomal damage (mutations) and effects on fetuses (teratogenesis). Chemicals with a "high degree of toxicity" also require special provisions for worker health. Although "select carcinogens" are specifically identified through reference to other publications, "reproductive toxins" and chemicals with a ''high degree of acute toxicity" are not specified further, which has made it difficult to apply these categories. Some institutions have chosen to adopt the OSHA Hazard Communication Standard definition of "highly toxic" (LD50 < 50 mg/kg oral dose) as a workable definition of "high degree of acute toxicity." There is very little agreement on how to determine "reproductive toxins." It is important to understand that the OSHA PELs and substance-specific standards do not include all hazardous chemicals. It is the laboratory manager's responsibility under the Laboratory Standard and the "general duty" clause to apply scientific knowledge in safeguarding workers against risks, even though there may be no specifically applicable OSHA standard. The OSHA-mandated special provisions for work with carcinogens, reproductive toxins, and substances that have a high degree of acute toxicity include consideration of "designated areas," use of containment devices, special handling of contaminated waste, and decontamination procedures. The OSHA requirement is for evaluation, assessment, and implementation of these special controls, when appropriate. These special provisions are to be included in the Chemical Hygiene Plan. The Laboratory Standard also requires quite detailed record-keeping, particularly with regard to records of exposure monitoring and medical surveillance, in those circumstances where exposure limits are exceeded or where work with especially hazardous substances is conducted. 9.C.5 Protection of Other Personnel in Laboratories OSHA standards apply only to "employees" of laboratory facilities. In many cases, students are not employees within the scope of the Occupational Safety and Health Act, but both moral and legal considerations suggest that colleges and universities provide the same protections to students as are provided to all employees regularly working in the laboratory. Custodial and maintenance staff who service the laboratory continue to be governed by other OSHA standards, particularly the Hazard Communication Standard, which sets forth the information, training, and health and safety protections required to be provided to nonlaboratory employees. 9.C.6 Federal Versus State Regulations Enforcement of the Laboratory Standard, as well as other OSHA standards, may be a shared responsibility of the federal government and of state occupational safety and health programs. Under Section 18 of the Occupational Safety and Health Act, individual states may be authorized by federal OSHA to administer the act if they adopt a plan for development and enforcement of standards that is "at least as effective as the Federal standards." These states are known as "state-plan" states. In states that do not administer their own occupational health and safety programs, federal OSHA is the regulator, covering all nonpublic employers. State-plan states have generally included public employees in their regulatory approach. What this means is that a given institution may be subject to (1) the federal Laboratory Standard, enforced by federal OSHA, (2) a state Laboratory Standard, enforced by state OSHA, or (3) if a public institution is not subject to OSHA regulation, state public institution health and safety regulations enforced by a state agency. The environmental health and safety office at each institution should have a copy of the applicable standard. Of the violations of the Laboratory Standard issued by OSHA, many have been for failure to have a Chemical Hygiene Plan or for a missing element in the plan. Another commonly cited violation is failure to meet the "Employee Information and Training" requirements of the Laboratory Standard. It is likely that OSHA enforcement of the Laboratory Standard will increase in the future, as state and federal OSHA inspectors focus more on laboratory activities and the implementation of this still relatively new standard. 9.C.7 Laboratory Standard Versus Hazard Communication Standard It is important to understand the distinction between the Laboratory Standard and the Hazard Communication Standard. As noted above, the Laboratory Standard is intended, with limited exceptions, to be the

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals OSHA standard governing employees who routinely work in laboratories. The Hazard Communication Standard, on the other hand, applies to all nonlaboratory operations "where chemicals are either used, distributed or are produced for use or distribution." The obvious difficulty is that workers in maintenance shops, even if in a laboratory building, would be covered by the Hazard Communication Standard, not the Laboratory Standard. The requirements of the Hazard Communication Standard are, in certain respects, more demanding than those of the Laboratory Standard. For example, the Hazard Communication Standard requires that each container of hazardous chemicals used by the employee be labeled clearly with the identity of the chemical and appropriate hazard warnings, whereas the Laboratory Standard requires only that employers "ensure that labels on incoming containers of hazardous chemicals are not removed or defaced." The Hazard Communication Standard further requires that copies of Material Safety Data Sheets (MSDSs) for each hazardous chemical be readily accessible to employees, whereas the Laboratory Standard requires only that employers ''maintain MSDSs that are received with incoming shipments, and ensure that they are readily accessible ...." Many institutions, faced with the difficulty of designing environmental health and safety programs that meet the requirements of the Laboratory Standard and the requirements of the Hazard Communication Standard, have opted to follow the requirements of the Hazard Communication Standard for all workplaces, laboratory and nonlaboratory, while additionally adopting and implementing the Chemical Hygiene Plan requirements of the Laboratory Standard as they apply to laboratories. Careful comparison of the two standards should be made when designing an environmental health and safety program. 9.D THE RESOURCE CONSERVATION AND RECOVERY ACT The Resource Conservation and Recovery Act (RCRA) was enacted by Congress in 1976 to address the problem of waste disposal and reduction. Subtitle C of that act established a system for controlling hazardous waste from generation to disposal. This is often referred to as the "cradle to grave" system. The cradle, however, is the point at which the hazardous material first becomes a "hazardous waste," not when it is first received in a laboratory. Under RCRA, the Environmental Protection Agency is given great responsibilities in promulgating detailed regulations governing the generation, transport, treatment, storage, and disposal of hazardous waste. RCRA and EPA regulations were written with a focus on industrial-scale generation of hazardous waste, but, with very limited exceptions, they also apply to laboratories that use chemicals. 9.D.1 Definition of a Generator It is important to understand who is a generator under RCRA. A generator is "any person, by site [emphasis added], whose act or process produces hazardous waste .. ." There are three categories of generator: (1) Large-quantity generators are those whose facilities generate 1,000 kg or more per month (about five 55-gallon drums of hazardous waste) or over 1 kg of "acutely hazardous waste" per month. By this measure, most large research institutions, including the larger universities, are large-quantity generators. (2) Small-quantity generators, to whom special rules apply, generate more than 100 but less than 1,000 kg of hazardous waste per month (and accumulate less than 6,000 kg at any one time) and less than 1 kg of "acutely hazardous waste" per month (and accumulate less than 1 kg at any one time). (3) A conditionally exempt small-quantity generator generates 100 kg or less of hazardous waste per month and less than 1 kg of "acutely hazardous waste." The special requirements applicable to conditionally exempt small-quantity generators can be found in 40 CFR 261.5. "Individual generation site" is defined by RCRA regulation as a contiguous site at or on which hazardous waste is generated. Because most colleges, universities, and research institutions are located in one geographic site, they are viewed as a single generator under the definition above, and the entire facility has a single EPA generator identification number. This means that each individual laboratory generating waste is not a "generator" within the terms of RCRA, but, as a part of the overall institutional "generator," each laboratory must comply with generator requirements. Obviously, multisite institutions are required to have separate EPA identification numbers for each site. In determining whether a site is an "individual generation site," some EPA regional offices have been quite strict in relying on the distinction of whether the site has any public roads, the reason being RCRA's objective of not allowing unregulated transport of hazardous waste on public ways. In the definitions section of the RCRA regulations, "on-site" is defined as "the same or geographically contiguous property which may be divided by public or private right-of-way, provided the entrance and exit between the properties is at a crossroads intersection, and access is by crossing as opposed to going along [emphasis added] the right-of-way." The significance of this interpretation is that hazardous

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals waste that is being transported can be sent only to a permitted treatment, storage, and disposal facility (TSDF). It cannot be moved legally to an unpermitted holding facility if such movement requires transport along a public road, even if the public road and the receiving location are within the boundaries of an institution. This has caused serious management problems for some multibuilding institutions and companies. Generators must obtain an EPA identification number, prepare the waste for transport, follow accumulation and storage requirements, manifest hazardous waste, and adhere to detailed record-keeping and reporting requirements. Although conditionally exempt small-quantity generators are partially exempt from these requirements, they must still identify their waste to determine whether it is hazardous, not accumulate more than 1,000 kg of hazardous waste, and treat or dispose of the waste on site, or ensure that the waste is sent to a permitted TSDF or a recycling facility. Also, generators producing more than 1 kg in a calendar month of "acute hazardous waste" (see below) are subject to full regulation under RCRA. While some industrial research laboratories and a few large universities have on-site EPA-permitted TSDFs, most colleges and smaller universities and research institutions do not. Their hazardous waste is shipped off-site, treated, stored, and disposed of at commercial EPA-permitted TSDFs. The process and requirements for EPA-permitting of a TSDF are very complex, involving construction of costly facilities, detailed operational plans, and specialized staff. It is important to note that state classification of generators may be different from the classifications outlined above. Some states regulate all generators of hazardous waste with no exemptions, and some states classify generators by waste type rather than by volume. 9.D.2 Definition of Hazardous Waste RCRA defines "hazardous waste" as solid waste that, "because of its quantity, concentration, or physical, chemical, or infectious characteristics may: 1) cause, or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness or 2) pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed." A "solid waste" under RCRA need not be solid! "Solid waste" is defined as "any ... discarded material, including solid, liquid, semisolid, or contained gaseous material ..." The term "discarded" includes any material that is abandoned, recycled, or "inherently wastelike.'' The term "hazardous waste" means any solid waste (as defined above) that: exhibits any of the characteristics of a hazardous waste (i.e., ignitability, corrosivity, reactivity, or toxicity as determined by EPA's Toxicity Characteristic Leaching Procedure (TCLP) test); has been listed as a hazardous waste by EPA regulation; is a mixture containing a listed hazardous waste and a nonhazardous solid waste; or is a waste derived from the treatment, storage, or disposal of a listed hazardous waste. Certain otherwise hazardous wastes are excluded from regulation. These include samples sent for testing, household waste, agricultural waste (not including pesticides), oil and gas production waste, and others not generally associated with laboratory activities. The RCRA regulations contain detailed provisions and testing procedures for determining if any particular chemical waste, not specifically listed in the regulations, is a "hazardous waste" within the RCRA definition. "Acute hazardous wastes" are those listed as such in 40 CFR 261.31 (the F020-27 series, the dioxin precursors) and 261.33 (e), the P list. 9.D.3 Accumulation Times and Amounts Under RCRA, a large-quantity generator may accumulate hazardous waste for up to 90 days without a special EPA permit, providing the waste container is in good condition, the container material or liner is compatible with the waste contained, the container is kept closed except when actually adding or removing waste, and the container is properly handled and stored. To accumulate waste for a longer period, an EPA permit as a "storage facility" is required. Some larger institutions have a central EPA-permitted TSDF, and longer storage times are allowed in accordance with the regulations and the permit conditions applicable to that institution. 9.D.4 Satellite Accumulation One RCRA regulation of particular relevance to academic and research laboratories is the provision that

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals a generator may accumulate up to 55 gallons of hazardous waste, or 1 quart of acutely hazardous waste, "at or near any point of generation where wastes initially accumulate which is under the control of the operator of the process generating the waste...." Under this provision, which is recognized by some but not all state RCRA-enforcement agencies, individual laboratories, or "satellite" locations as they are sometimes termed, may be allowed to accumulate and store hazardous waste, but the waste must be dated and removed within 3 calendar days after reaching the 55 gallon limit. However, safe practice and the requirements of state and local regulation should guide laboratory managers in adhering to reasonable limits on accumulation volume and time. Prudent practice is to limit accumulation time to no more than 1 year (preferably less), and 55 gallons may be too large a quantity for a laboratory location, because of space limitations, fire code limitations, and potential spill or release hazards. When waste accumulates for long periods, laboratory workers tend to forget about it. Hazardous waste, even in small quantities, should never be forgotten. 9.D.5 Drain Disposal of Hazardous Waste Only a few years ago, it was common practice to dispose of many laboratory wastes down the drain. Today, the indiscriminate disposal to the sanitary sewer of laboratory chemicals is not acceptable. Most laboratory drain systems are connected to sanitary sewer systems, and their effluent will eventually go to a sewage treatment plant. Some chemicals can interfere with the proper functioning of sewage treatment facilities or affect particularly sensitive bodies of water into which the chemical is discharged. In the laboratory drain system itself, some chemicals can create hazards of fire, explosion, or local air pollution. Others can corrode the drain system. It is essential to recognize that the characteristics of wastewater treatment plants vary from one locality to another. These factors and local regulations govern what types and concentrations of chemicals can be disposed of. While RCRA regulations do exempt mixtures of hazardous waste and domestic sewage from hazardous waste regulation, local regulations of drain disposal are often more restrictive. While drain disposal of some nonhazardous chemicals may be acceptable, drain disposal of hazardous chemicals is permissible only under carefully prescribed circumstances. Some institutions, responding to strict local controls and concerns, have, as a matter of policy, simply adopted a conservative course and banned the drain disposal of any laboratory chemicals. If the institution, after appropriate consideration, determines that some drain disposal should be permitted, the following general points of guidance should be adhered to: Use drain disposal only if the drain system flows to a wastewater treatment plant, and not into a septic tank system or a storm sewer system that flows directly into surface water. Make sure that the chemical to be disposed of is compatible with other materials being disposed of, and compatible with the piping material. Monitor sewer disposal of laboratory waste by individual workers or students for adherence to guidelines on types of chemicals, quantities and rates, and flushing procedures. Remember that only those compounds that are reasonably soluble in water are suitable for drain disposal. (Chapter 7 contains more detailed guidance on these and other points regarding drain disposal.) Under the Federal Water Pollution Control Act, all direct dischargers, that is, those who discharge effluents directly into rivers, streams, or other bodies of water, are required to have a National Pollutant Discharge Elimination Systems (NPDES) permit. Indirect dischargers, that is, those who discharge effluents into publicly owned sewage treatment works, are not required to have a permit, but must be subject to discharge conditions set by the local wastewater treatment authority. Because many of these local sanitary sewer and water treatment districts have their own, more restrictive, requirements, there should be no drain disposal of hazardous materials without checking with local authorities. 9.D.6 Empty Containers A container or inner liner of a container that contained hazardous waste is "empty" under RCRA regulations if all waste has been removed by standard practice and no more than 2.5 cm (1 inch) of residue, or 3 percent by weight of containers less than 110 gallons, remains. These should be taken as upper limits, and in practice all "capturable" quantities of the substance should be removed. As an "empty" container, it is no longer subject to RCRA regulation. It should be noted, however, that if the container held acute hazardous waste, triple rinsing or equivalent measures are required before the container is "empty" within the RCRA regulations. Indeed, rinsing with water or a detergent solution is prudent for all hazardous waste containers. Rinsates resulting from the cleaning of empty containers that contained acutely hazardous waste are themselves hazardous waste and must be

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals disposed of accordingly. Rinsates resulting from cleaning of hazardous waste containers may or may not be hazardous waste, depending on whether the waste in the container was listed in 40 CFR 261, Subpart D, or in all cases on whether they fall within the RCRA hazardous waste characteristics of ignitability, corrosivity, reactivity, or toxicity (40 CFR 261, Subpart C). It should also be noted that the regulations regarding empty containers apply to all hazardous waste containers, not just those containing laboratory chemicals. Paint cans, insecticide containers, cleaning supply bottles, and so forth, are also covered. Some institutions view it as more convenient and/or more prudent simply to handle all empty chemical containers from laboratories as hazardous waste and dispose of them accordingly. Others find it feasible to clean the containers as required, remove labels, dispose of the rinsate properly, and then dispose of or recycle the empty containers along with ordinary nonhazardous waste. Obviously, the latter course can substantially reduce the volume of reportable hazardous waste quantities generated as well as reduce the total hazardous waste disposal costs. 9.D.7 Land Disposal of Hazardous Waste In the 1984 RCRA amendments, Congress required EPA to prohibit land disposal of hazardous waste unless it was processed using EPA-developed treatment standards that were protective of human health and the environment. As a result, EPA established certain prohibitions on land disposal and also established treatment standards. The net effect of these regulations is a virtual total ban on direct land disposal of hazardous waste. The detailed EPA regulations may be found at 40 CFR 261. There are provisions for special handling and treatment of certain wastes disposed of in Lab Packs. 9.D.8 In-Laboratory Treatment "Treatment" is very broadly defined by RCRA (40 CFR 260.10) to include "any method, technique, or process, including neutralization, designed to change the physical, chemical, or biological character or composition of any hazardous waste...." Basically, RCRA prohibits any treatment without a permit, with only very limited exceptions. Those exceptions are as follows: Treatability studies, that is, investigation of new methods of treating or detoxifying hazardous waste, in which the quantities of hazardous waste treated are under certain specified limits. While a permit is not required, there are significant record-keeping and reporting requirements. Treatment procedures in laboratories where the treatment procedure is part of the experiment. While not specifically addressed in the RCRA regulations, a rationale for this exception is that the material has not been declared a "waste" subject to RCRA regulation. "Closed loop" treatment processes where "only tank storage is involved and the entire process through completion of reclamation is closed by being entirely connected with pipes" are allowed. For most laboratories, such a closed loop system is not feasible for treatment. Elementary neutralization of waste that is hazardous only because of the characteristic of corrosivity. Treatment under certain circumstances by conditionally exempt small-quantity generators. For most laboratories, especially academic research laboratories, the obtaining of a special EPA treatment permit is not feasible because of the great expense involved in the application process, and the detailed record-keeping, analytical, and other requirements attendant upon a permitted treatment operation. Some states have adopted a "permit-by-rule" regulatory approach, allowing categorical or blanket permitting of certain small-scale treatment methods. Because of the regulatory complexities governing in-laboratory treatment and the differing interpretations applied by RCRA enforcement agencies, it is recommended that the researcher contact, either directly or through the institution's environmental health and safety and legal offices, the cognizant EPA office prior to undertaking in-laboratory treatment. 9.D.9 Waste Minimization Under RCRA One of the goals of RCRA is to reduce or eliminate the generation of hazardous waste. EPA uses the term "waste minimization" to mean the reduction of hazardous waste generated prior to any treatment, storage, or disposal of the waste. It is defined as any source reduction or recycling activity that results in either reduction of the total volume of hazardous waste or reduction of the toxicity of the hazardous waste. RCRA requires large-quantity generators to identify in their biennial report to EPA (or the state) what has actually been achieved as a result of efforts undertaken to reduce the volume and toxicity of waste. In addition, generators are required to certify on the manifest accompanying off-site shipment of waste that they have a waste minimization program in place. Interim guidelines for waste minimization programs have been published by EPA (U.S. EPA, 1990).

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals 9.D.10 Transportation of Chemicals and Hazardous Waste Transportation of both hazardous materials and hazardous waste is primarily regulated by the Department of Transportation (DOT), under authority of the Hazardous Materials Transportation Act. The RCRA rules include some additional requirements for transportation of hazardous waste. The DOT regulations applicable to transport of laboratory chemicals include those governing packaging, labeling, marking, placarding, and reporting of discharges. A transporter is defined as any person engaged in the off-site transportation of hazardous materials or waste. These regulations apply not only to those who actually transport, but also to those who initiate or receive hazardous waste shipments. Those who prepare hazardous materials for transportation must also meet certain training requirements. These requirements have been recently promulgated under the Hazardous Materials Transportation Uniform Safety Act. For institutions whose laboratory operations are at a single site, transportation within that site is not regulated, as long as that transport involves no travel along public ways. Most institutions, however, have developed policies for on-site transportation covering labeling, segregation of incompatibles, containment and double containment, and other necessary safeguards to prevent accidental release to the environment or injury to persons during transportation, even if not required by governmental regulation. If off-site transportation of any hazardous material, including shipments of small samples to colleagues, is contemplated, the laboratory worker should consult the institution's environmental health and safety office and/or the EPA/DOT regulations. 9.D.11 Underground Storage Tanks Subtitle I of RCRA was enacted to control and prevent leaks from underground storage tanks storing hazardous substances, including petroleum products. It is not uncommon to discover underground storage tanks that may have been installed many years ago in or near laboratory buildings. Inventorying of these tanks and establishing systems for leak detection, record-keeping, reporting, cleanup or other corrective action, and ultimately closure, are required by RCRA regulations. All new tanks installed must meet EPA and state design specifications for the tanks themselves and associated piping and cathodic protection systems. All underground storage tanks must comply with the regulations for new tanks by December 22, 1998. 9.E THE CLEAN AIR ACT The Clean Air Act (CAA) regulates emissions into the air. Under the 1990 amendments to the CAA, emissions of sulfur dioxide, volatile organic compounds (VOCs), hazardous air pollutants (HAPs), and ozone-depleting chemicals (ODCs) are being more rigorously regulated. Institutions with large research laboratory operations will be affected by these rules, given their use of a variety of volatile chemicals and solvents that result in VOC or HAP emissions. Laboratory managers should work closely with the institution's office of environmental health and safety in addressing issues of CAA regulatory application and compliance. Under the structure of the CAA, states and local air quality districts are responsible with EPA for developing emissions standards for local areas. These standards may vary. For example, areas with serious air pollution problems may develop stricter emissions controls. Colleges, universities, or other institutions with research laboratories that have the potential to emit one or more of the listed hazardous air pollutants in amounts greater than 10 tons/year of a single hazardous air pollutant or 25 tons/year of total hazardous air pollutants will be considered a major source and covered by the regulations. The "tons per year" calculation is based on total potential emissions by facilities in a contiguous area and under common control, including such sources as power plants and boilers, and, in a few states or localities, fume hoods. Thus, many of the larger research institutions will be affected by these new standards. EPA will be establishing emission standards based on "maximum achievable control technologies" for each source category. The 1990 amendments also require EPA to establish a special source category for research or laboratory facilities. EPA has not yet issued specific laboratory-directed regulations, but, as noted above, laboratories that are part of a large university or research institution will be regulated as part of that combined major source. Laboratories should also be aware of regulatory provisions relating to stratospheric-ozone-depleting substances. The list of such substances can be found at 40 CFR 82, Appendixes A and B to Subpart A. The list includes as "Class I" substances most common freons, carbon tetrachloride, and methyl chloroform. The regulations prohibit the movement in interstate commerce of these substances and other listed ozone-depleting substances. It is clear, however, that CAA enforcement, which has, up to now, largely focused on industrial emissions, will focus increasingly on emissions from universities and other research institutions. Laboratory researchers should work closely with the institution's environmen-

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals tal health and safety staff and/or with the local air quality authorities in monitoring and achieving compliance with these new CAA standards. Laboratory managers should also participate, along with their institution's environmental regulatory specialists, with the regulatory agencies in the development of workable rules for the laboratory special source category. 9.F SARA TITLE III, COMMUNITY RIGHT-TO-KNOW AND EMERGENCY NOTIFICATION AND RESPONSE Under Title III of SARA, the Superfund Amendments and Reauthorization Act, facilities that use hazardous chemicals in their operations must maintain the Material Safety Data Sheets (MSDSs) required under OSHA's Hazard Communication Standard, submit copies of the MSDSs, provide inventories of hazardous chemicals, and report accidental releases to emergency planning authorities. The basic rationale for these regulations is twofold; the community's "right to know" what hazardous materials are present in facilities in their community, and the need for emergency response authorities and local fire departments to know what substances are being used or stored in case they are required to respond to a fire, explosion, release, or other emergency. "Hazardous chemical," however, is defined to exclude any chemical "to the extent it is used in a research laboratory or hospital or other medical facility under the direct supervision of a technically qualified individual." It is important to note, however, that (1) nonlaboratory uses of hazardous chemicals are not excluded, and (2) state or local laws relating to community right-to-know or emergency notification and response may, regardless of SARA exemptions, require chemical inventories or release notification for research laboratories. Two other aspects of SARA Title III deserve mention. They are the emergency planning notification requirement and the release notification requirement. The emergency planning notification regulation requires that any institution that has an EPA-listed "extremely hazardous substance" on site in greater than EPA-specified "threshold planning quantities" must notify the state emergency response authorities. The quantity limits are based on the total quantity of the hazardous chemical present at the facility rather than in an individual laboratory. The release notification provisions require that an institution notify state and community authorities in the event of a release into the environment of a "hazardous substance" or an "extremely hazardous substance" in excess of EPA-established "reportable quantities." Another important aspect of SARA is the requirement for training of those who respond to emergencies involving hazardous materials. Although the training requirements are contained in OSHA regulations, Congress has stipulated that they should apply to all employers in all states. Researchers should contact their institution's environmental health and safety and/or local emergency response agencies to ascertain locally applicable requirements for notification and training. 9.G THE TOXIC SUBSTANCES CONTROL ACT The Toxic Substances Control Act (TSCA) is intended to control new or existing chemicals that may present unreasonable risks to human health or the environment. In 1976, Congress enacted this statute to fill gaps in chemical control not covered by other laws and agencies, such as the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Food and Drug Administration (FDA), and the Occupational Safety and Health Administration (OSHA). TSCA is not intended to overlap other laws that already regulate specified chemical uses. TSCA authorizes EPA to administer and enforce the rules it develops under TSCA. TSCA's numerous sections deal with various aspects of chemical control: reporting and record-keeping requirements of chemical manufacturers and processors, establishment of an inventory of existing chemicals in U.S. commerce (the TSCA Inventory), and requirements for premanufacture notification (PMN) of new chemicals to EPA. TSCA also gives EPA authority to require chemical testing, ban or otherwise control chemicals in commerce, control polychlorinated biphenyls (PCBs), enforce and set penalties for violations, and provide protection for confidential business information submitted to EPA. TSCA's provisions have a major impact on chemical manufacturers and their associated research and development (R&D) laboratories. Primary regulations that can affect R&D laboratories are the R&D exemption from the PMN and "significant adverse reactions" in TSCA 8(c). 9.G.1 Research and Development (R&D) Exemption from the Premanufacture Notification (PMN) Before a company can manufacture or import a new chemical (a chemical not listed on the TSCA Inventory), it must file a PMN with EPA and allow the agency a

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals specified period of time to assess the risks to health or the environment. Failure to do so can result in penalties as high as $25,000 per day of violation. It should be noted that importation is the same as manufacturing under TSCA. There is an exemption from the PMN requirement for chemicals used for R&D, or in a use regulated by another agency (such as solely for medical use regulated by FDA), but EPA still considers R&D use to be a commercial activity. There are significant personnel notification and record-keeping requirements under this exemption (R&D Exemption: 40 CFR 720.3, 720.36, and 720.78). The following is a summary of TSCA rules concerning R&D exemption requirements: Operation under the R&D exemption requires notification in writing to those who may be exposed to the exempt substance. However, R&D conducted solely in R&D laboratories results in minimal requirements. New substances for which no hazard information is available need only carry the appropriate labels. All containers of R&D-exempt material or of mixtures containing the material should have an experimental material label and a TSCA R&D label. While EPA does not specify the language, the following is an example of a TSCA R&D label: This material is not listed on the TSCA Inventory. It should be used for research and development purposes only under the direct supervision of a technically qualified individual. On any Material Safety Data Sheet (MSDS) in the "composition, information on ingredients" section for an R&D-exempt material, words to the following effect should be indicated: This material is for R&D evaluation only. It can only be used for R&D evaluations until PMN review by EPA is completed. If this material is used in plants or non-R&D locations for R&D evaluation, its use must be supervised by a technically qualified individual. Review all sections of this MSDS prior to use. If an R&D-exempt material leaves a "prudent laboratory practices" area-e.g., if a sample is sent to a customer or the material is used in a pilot plant or manufacturing plant-you must provide written notification to those exposed to the substance. Your notification must inform users of any information in your possession or control on the risk to health from such exposure, or must state that no information is known about the toxicity of the substance. You should request a review of health studies or EPA actions on the R&D material by your laboratory's toxicologist and maintain a record of the response. The adequacy of the notification(s) is the responsibility of the manufacturer or importer, and copies of such notice(s) must be kept for 5 years. A checklist for R&D samples sent to plants or outside processors would include: shipping the material with appropriate experimental material and TSCA R&D container labels affixed, and an enclosed copy of the MSDS. providing a letter to each recipient that indicates any known hazard information, that the substance is solely for R&D purposes, and that use of the substance requires supervision by a technically qualified individual. maintaining a record of names and addresses of sample recipients, sample identification code, amount of material, and purpose of the sample. Copies of the written notifications provided (i.e., the letter, the MSDS, and copies of all labels affixed to sample containers) should be maintained in a file for 5 years (40 CFR 720.78, Record-keeping). EPA did not set exact quantities for R&D exemption volumes. The EPA standard is "not greater than reasonably necessary for such (R&D) purposes." Let that serve as your standard for R&D-stage activities, with the understanding that you are in the best position to determine what reasonable R&D volumes are, given the technology and product development requirements for making and processing a particular material for your R&D needs. Note that stockpiling of R&D material for later manufacturing is prohibited if the material is not on the TSCA Inventory. 9.G.2 Record-keeping Requirements for Significant Adverse Reaction Allegations--TSCA 8(C) One subpart of Section 8 of TSCA can affect R&D laboratories. TSCA 8(c) is the requirement to keep records of allegations of significant adverse effects of chemicals. The allegations need not be proved to be subject to this record-keeping requirement. If a worker becomes aware of an allegation of a significant adverse reaction to a chemical (e.g., a skin rash, an allergic reaction, respiratory effects), he or she should contact the supervisor or the health, safety, and environmental

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Prudent Practices in the Laboratory: Handling and Disposal of Chemicals office in the organization. This office or another responsible office must maintain a written record of the allegation in its files. TSCA requires that this record be kept for 5 years if made by someone outside the organization, and for 30 years if made by an employee. 9.G.3 Regulations Covering Polychlorinated Biphenyls (PCBs) One set of regulations under TSCA speaks directly to research facilities, colleges, and universities, however. Those are the regulations governing polychlorinated biphenyls (PCBs) and monochlorobiphenyl. Essentially, PCB manufacturing in concentrations of more than 50 ppm is banned, and PCB use in any concentration is banned unless used in a "totally enclosed manner." There are exceptions to these conditions. Two of possible relevance to researchers are those that allow the use of "small quantities for research and development" and use "as an immersion oil in microscopy." Because of the stringency of regulation, researchers contemplating working with PCBs should contact their institution's environmental health and safety office or the regional EPA office to determine any applicable requirements. The most common use of PCBs is as dielectric fluid in transformers, capacitors, and other electrical equipment. Although PCB-containing equipment is no longer manufactured, PCB-containing transformers are still in use. PCBs are often found in transformers and capacitors of laboratory equipment, especially high-voltage transformers. Such items should be tested and appropriate steps taken before continued use or disposal. Any leaking oil from a transformer should be checked for PCB content. Due to the bioaccumulation of PCBs, EPA has issued very strict regulations governing the use, servicing, and disposal of PCB-containing transformers. While most PCB-containing transformers may continue to be used for the remainder of their useful lives, they must be inventoried, inspected frequently for leaks, and serviced in accordance with stringent EPA procedures, and they are subject to record-keeping and reporting requirements. EPA offices have been very rigorous in the enforcement of the PCB regulations, and large fines have been imposed on some institutions. Researchers should notify their institution's environmental health and safety office of any transformers or capacitors that might contain PCBs. 9.H REGULATION OF LABORATORY DESIGN AND CONSTRUCTION Laboratory design and construction are regulated mainly by state and local laws that incorporate, by reference, generally accepted standard practices set out in various uniform codes, such as the Uniform Building Code, the Uniform Fire Code, and the National Fire Protection Association standards. For laboratory buildings where hazardous chemicals are stored or used, there are detailed requirements covering such things as spill control, drainage, containment, ventilation, emergency power, special controls for hazardous gases, fire prevention, and building height. In addition, OSHA standards affect some key laboratory design and construction issues, for example, eyewashes, safety showers, and special ventilation requirements. Other consensus standards prepared by organizations such as the American National Standards Institute (ANSI) and the American Society of Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE) are relevant to laboratory design. It is not uncommon for various codes and consensus standards to be incorporated into state or federal regulations.