11 Safety Laws and Standards Pertinent to Laboratories


11.A.1 Making Safety Laws and Their Rationale

11.A.2 OSHA and Laboratories

11.A.2.1 OSHA Enforcement and State OSHA Laws

11.A.2.2 The General Duty Clause and “Nonlaboratory” OSHA Standards

11.A.2.3 Laboratory Standard Versus Hazard Communication Standard

11.A.2.4 PELs, TLVs, and RELs

11.A.3 Understanding Other Laboratory Safety Requirements



11.C.1 OSHA Standards for Specific Chemicals

11.C.2 The OSHA Laboratory Standard

11.C.2.1 The Chemical Hygiene Plan

11.C.2.2 Particularly Hazardous Substances

11.C.3 Chemical Facility Anti-Terrorism Standards

11.C.4 Regulations Covering Polychlorinated Biphenyls (PCBs)



11.E.1 Management of Chemical Hazardous Waste

11.E.1.1 Definitions and Types of Hazardous Waste Generators

11.E.1.2 Implications of EPA’s Definition of On-Site

11.E.1.3 Minimum Requirements for Generators

11.E.1.4 RCRA Waste Minimization Requirements

11.E.1.5 Transportation of Chemicals and Hazardous Waste

11.E.2 Management of Radioactive and Biohazardous Waste

11.E.3 Discharges to the Sewer

11.E.4 Air Emissions from Laboratories


11.F.1 General Shipping Regulations

11.F.2 EPA Requirements for Chemical Export and Import

11.F.2.1 TSCA Research and Development Exemption

11.F.2.2 TSCA Record-Keeping Requirements for R&D Laboratories

11.F.2.3 Chemical Exports from R&D Laboratories

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11 Safety Laws and Standards Pertinent to Laboratories 11.A INTRODUCTION 267 11.A.1 Making Safety Laws and Their Rationale 267 11.A.2 OSHA and Laboratories 268 11.A.2.1 OSHA Enforcement and State OSHA Laws 268 11.A.2.2 The General Duty Clause and “Nonlaboratory” OSHA Standards 268 11.A.2.3 Laboratory Standard Versus Hazard Communication Standard 268 11.A.2.4 PELs, TLVs, and RELs 269 11.A.3 Understanding Other Laboratory Safety Requirements 269 11.B REGULATION OF LABORATORY DESIGN AND CONSTRUCTION 272 11.C REGULATION OF CHEMICALS USED IN LABORATORIES 273 11.C.1 OSHA Standards for Specific Chemicals 273 11.C.2 The OSHA Laboratory Standard 273 11.C.2.1 The Chemical Hygiene Plan 274 11.C.2.2 Particularly Hazardous Substances 274 11.C.3 Chemical Facility Anti-Terrorism Standards 275 11.C.4 Regulations Covering Polychlorinated Biphenyls (PCBs) 275 11.D REGULATION OF BIOHAZARDS AND RADIOACTIVE MATERIALS USED IN LABORATORIES 276 11.E ENVIRONMENTAL REGULATIONS PERTAINING TO LABORATORIES 276 11.E.1 Management of Chemical Hazardous Waste 276 11.E.1.1 Definitions and Types of Hazardous Waste Generators 276 11.E.1.2 Implications of EPA’s Definition of On-Site 276 11.E.1.3 Minimum Requirements for Generators 277 11.E.1.4 RCRA Waste Minimization Requirements 277 11.E.1.5 Transportation of Chemicals and Hazardous Waste 277 11.E.2 Management of Radioactive and Biohazardous Waste 278 11.E.3 Discharges to the Sewer 278 11.E.4 Air Emissions from Laboratories 278 11.F SHIPPING, EXPORT, AND IMPORT OF LABORATORY MATERIALS 278 11.F.1 General Shipping Regulations 278 11.F.2 EPA Requirements for Chemical Export and Import 279 11.F.2.1 TSCA Research and Development Exemption 279 11.F.2.2 TSCA Record-Keeping Requirements for R&D Laboratories 279 11.F.2.3 Chemical Exports from R&D Laboratories 279 265

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266 PRUDENT PRACTICES IN THE LABORATORY 11.F.2.4 TSCA Requirements for Other Chemical Shipments 280 11.F.2.5 Chemical Imports from R&D Laboratories 280 11.F.2.6 Nanomaterials Under TSCA 280 11.F.3 Requirements for Biological Export and Import 280 11.F.4 Other Export Regulations 281 11.G LABORATORY ACCIDENTS, SPILLS, RELEASES, AND INCIDENTS 281 11.G.1 Laboratory Injuries and Illnesses 281 11.G.2 Planning for Chemical Emergencies 281 11.G.3 Notification Requirements for Spills, Releases, and Other Emergencies 281 11.G.4 Emergency Training and Response 281

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267 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES 11.A INTRODUCTION desired result, for example, improved employee safety or environmental protection. Proposed laws are often There are a number of federal, state, and local laws, known by their Senate or House file numbers, for ex- regulations, ordinances, and standards that pertain to ample, S.xxx or H.R.xxx. Copies of proposed laws can the laboratory activities and conditions that affect the be obtained by visiting thomas.loc.gov, the Web site for environment, health, and safety. These are reviewed the legislative search engine at the Library of Congress, briefly in this chapter. For safety laws and standards or by requesting them from local offices of House or described in detail elsewhere in this book, this chapter Senate members. Sponsors of proposed legislation are will refer to that section. open to comment from the public. Once a law is passed, Laws, rules, regulations, and ordinances are created it is known by its Public Law number, for example, and enforced by federal, state, and local governments. P.L. 94-580, Resource Conservation and Recovery Act International regulations apply to air and marine (RCRA). It is published in the United States Code and is transport of laboratory materials. Safety standards referenced by title and section number; 42 USC § 6901 and codes are created by nongovernmental bodies, but et seq. is the citation for RCRA. are important to know because they may be required When a law is passed, it is assigned to an administra- by a law (by reference), as condition of occupancy, by tive unit (agency or department) for development of your insurance company, by an accrediting body, or as rules and regulations that will implement the purpose a widely accepted industry standard. In some cases, of the legislation. The major federal agencies involved following a safety guideline is a condition of receiving in regulation of laboratory chemicals are the U.S. Oc- a research grant. cupational Safety and Health Administration (OSHA), Please note that this chapter is not meant to be a com- the U.S. Environmental Protection Agency (EPA), the pliance guide. This chapter only provides an overview U.S. Drug Enforcement Agency, the U.S. Department of certain laws. Further, this chapter mostly focuses on of Homeland Security (DHS), and the U.S. Department federal requirements. State and local requirements may of Transportation (DOT). Proposed regulations are be more stringent, so be sure to check to determine the published in the Federal Register, a daily publication of specific rules that apply. federal agency activities. Typically, a public comment period and perhaps public hearings are specified, dur- 11.A.1 Making Safety Laws and Their ing which all affected parties have an opportunity to Rationale present their support for or concerns with the regula- tions as proposed. This is the second significant op- Organizations that handle chemicals in laboratories portunity for involvement in the regulatory process. should participate in the regulatory process so that Final rules are published in the Federal Register and in regulators will understand the impact that proposed the Code of Federal Regulations (CFR), which is updated rules can have on the laboratory environment. The annually to include all changes during the previous best way to provide input to this process is through year. Rules in the CFR are referenced by title and part dialogue with the regulators, which can take place number; for example, 40 CFR Parts 260–272 is the cita- directly or in collaboration with the institution’s en- tion for RCRA’s hazardous waste rules. vironmental health and safety (EHS) or governmental It is helpful to understand the rationale that under- relations office. Also, professional associations, such as lies EHS laws and regulations. These laws reflect con- the American Chemical Society (ACS), the American gressional, state, and local legislative concerns about Industrial Hygiene Association (AIHA), the American worker safety, human health, and the environment, Conference of Governmental Industrial Hygienists and enjoy strong public support. (ACGIH), and the American Institute of Chemical En- Regulations and compliance with them is com- gineers (AIChE), as well as trade associations such as plicated by the fact that it is a virtual impossibility the American Chemistry Council (ACC) and the Cam- for EHS regulators to weigh every risk precisely. To pus Health Safety and Environmental Management As- attempt chemical-by-chemical regulation of the thou- sociation (CHSEMA), regularly comment on proposed sands of known, and unknown, chemicals would be regulations, especially proposed federal regulations so onerous and time-consuming as to leave many (which, by law, require solicitation of comment from serious hazards unregulated. Consequently, regula- interested parties). Participation in the regulatory pro- tors attempt to strike a balance by regulating classes cess through such groups is encouraged. of hazards and risks. A brief description of the federal legislative and Those managing and working in laboratories should regulatory processes may be helpful. Laws are a also recognize that violation of EHS laws and regula- product of legislative activity. Legislation is usually tions not only may pose unnecessary risks to those in proposed by senators and representatives to achieve a the laboratory and the surrounding community, but

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268 PRUDENT PRACTICES IN THE LABORATORY also can result in significant civil penalties (at publica- 11.A.2.2 The General Duty Clause and tion of this book, some laws allow maximum fines of “Nonlaboratory” OSHA Standards more than $30,000 per day per violation), as well as Another important point to understand about OSHA criminal penalties. Violations can erode community and laboratories is that although the Laboratory Stan- confidence in an institution’s seriousness of purpose dard supersedes existing OSHA health standards, other in safeguarding the environment and complying with OSHA rules on topics not specifically addressed in the law. Prudent practice requires not only scientific the standard remain applicable. The so-called general prudence, but also prudent behavior in terms of pre- duty clause of the Occupational Safety and Health Act, venting the risks of noncompliance, adverse publicity, which requires an employer to “furnish to each of his and damage to public trust and an institution’s com- employees . . . a place of employment . . . free from munity support. recognized hazards that are likely to cause death or serious physical harm . . .” and requires an employee to “comply with occupational safety and health stan- 11.A.2 OSHA and Laboratories dards and all rules . . . issued pursuant to this chapter It is important to understand the relationships which are applicable to his own actions and conduct” between the regulations and standards that mediate continues to be applicable and, indeed, is one of the laboratory activities. The OSHA Laboratory Standard most commonly cited sections in cases of alleged (Occupational Exposure to Hazardous Chemicals in OSHA violations. Laboratories, 29 CFR § 1910.1450) is the primary regu- lation, but laboratory personnel and EHS staff should understand its relationship to the hazard communi- 11.A.2.3 Laboratory Standard Versus Hazard cation standard. In addition, the general duty clause Communication Standard is often invoked, and OSHA standards not written As noted above, the Laboratory Standard is in- specifically for laboratories may also apply. Labora- tended, with limited exceptions, to be the primary tory personnel also need to know the relationship OSHA standard governing employees who routinely between OSHA’s permissible exposure limits (PELs), work in laboratories. The Hazard Communication ACGIH threshold limit values (TLVs), and the National Standard, on the other hand, applies to all nonlabo- Institute of Occupational Safety and Health (NIOSH) ratory operations “where chemicals are either used, recommended exposure limits (RELs). distributed or are produced for use or distribution.” The obvious difficulty is that workers in mainte- nance shops, even if in a laboratory building, would 11.A.2.1 OSHA Enforcement and State OSHA be covered by the Hazard Communication Standard, Laws not the Laboratory Standard. The requirements of the Enforcement of OSHA standards (such as the Labo- Hazard Communication Standard are, in certain re- ratory Standard), may be a shared responsibility of the spects, more demanding than those of the Laboratory federal government and of state occupational safety Standard. For example, the Hazard Communication and health programs. Under Section 18 of the Occu- Standard requires that each container of hazardous pational Safety and Health Act, individual states may chemicals used by the employee be labeled clearly with be authorized by federal OSHA to administer the act the identity of the chemical and appropriate hazard if they adopt a plan for development and enforcement warnings, whereas the Laboratory Standard requires of standards that is at least as effective as the federal only that employers “ensure that labels on incoming standards. These states are known as “state-plan” containers of hazardous chemicals are not removed or states. In states that do not administer their own occu- defaced.” pational safety and health programs, federal OSHA is The Hazard Communication Standard further re- the regulator, covering all nonpublic employers. State- quires that copies of material safety data sheets (MS- plan states have generally included public employees DSs) for each hazardous chemical be readily accessible in their regulatory approach. What this means is that a to employees, whereas the Laboratory Standard re- given institution may be subject to (1) the federal Labo- quires only that employers ‘’maintain MSDSs that are ratory Standard, enforced by federal OSHA; (2) a state received with incoming shipments, and ensure that laboratory standard, enforced by state OSHA; or (3) if they are readily accessible. . . .” a public institution is not subject to OSHA regulation, Custodial and maintenance staff who service the state public institution health and safety regulations laboratory continue to be governed by the Hazard enforced by a state agency. The EHS office at each in- Communication Standard and other OSHA standards, stitution should have a copy of the applicable standard. which set forth the information, training, and health

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269 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES and safety protections required to be provided to non- exposure limit for airborne concentration (lower than laboratory employees. its associated PEL) that, if exceeded, requires certain Many organizations, faced with the difficulty of de- additional protective measures to be implemented, signing EHS programs that meet both the requirements such as additional confirmatory exposure monitoring, of the Laboratory Standard and the requirements of training, or medical surveillance. Although personal the Hazard Communication Standard, have opted to exposures in research laboratory environments are follow the requirements of the Hazard Communication generally controlled well below all of these limits by Standard for all workplaces, laboratory and nonlabora- the use of local exhaust devices and room air change tory, while additionally adopting and implementing rates, laboratories working with any of the chemicals the Chemical Hygiene Plan requirements of the Labo- covered by an OSHA substance-specific standard must ratory Standard as they apply to laboratories. Careful be aware of the applicable regulatory provisions and comparison of the two standards should be made when implement them. designing an EHS program. RELs are additional exposure values that are devel- oped by the National Institute for Occupational Safety and Health (NIOSH). Like TLVs, RELs are not legal 11.A.2.4 PELs, TLVs, and RELs standards but are science-based recommendations that OSHA has developed PELs for chemicals. These are do not need to take into account feasibility, financial enforceable regulatory limits for the air concentration impact, or other consequences of their use. As a result, of individual substances to which a worker may be RELs and TLVs are generally more conservative (i.e., exposed. Many PELs are based on TLVs, which are lower, more protective) than OSHA’s limits. nonregulatory exposure limits prepared by ACGIH using existing published, peer-reviewed scientific lit- 11.A.3 Understanding Other Laboratory erature. Quoting the TLV booklet (ACGIH, 2009), “The Safety Requirements TLVs . . . represent conditions under which ACGIH believes that nearly all workers may be repeatedly ex- These rules are vast, complex, and intricate in their posed without adverse health effects. They are not fine details and interrelationships. As noted above, the ap- lines between safe and dangerous exposures, nor are plication and specifics of federal laws vary from state they a relative index of toxicology.” PELs and TLVs are to state, local jurisdictions, and among federal regula- average concentrations for a normal 8-hour workday tory agency regional offices. Further, there is a great and a 40-hour workweek. This time-weighted average variety of state and local laws, and so requirements (TWA) approach to evaluating airborne contaminant depend on the laboratory’s location. State and local exposure means that some periods of the day may have laws are not covered here, and so specific requirements higher or lower exposures than others, reflecting the may vary from the general information provided here. variability in most work with chemicals. Where available, an EHS officer who is familiar with For a small number of compounds, both OSHA and the details of these rules can act as a resource for sci- ACGIH have also established a short-term exposure entists. Smaller organizations can seek advice directly limit (STEL), a concentration considered safe for no from their counsel, insurance provider, regulatory more than four 15-minute periods a day. STELs are agencies, EHS professionals at other organizations, or published only for compounds where toxic effects consultants. have been reported from high-level, short-duration Table 11.1 lists safety laws that pertain to laborato- exposures in humans or animals. In addition, both ries, along with their associated regulations. This table groups have also established ceiling limits for some is not comprehensive. As noted previously, a detailed compounds (indicated by a “C” preceding the TLV or explanation of these requirements, and all the non- PEL value). The ceiling limit is the concentration that regulatory safety standards that apply to laboratories, should not be exceeded during any time portion of is beyond the scope of this book. Laboratory safety exposure. For compounds that include neither a STEL standards that are among the most relevant are those nor a C notation, a limit on the upper level of exposure published by the American Industrial Hygiene Asso- should still be imposed. According to the TLV booklet, ciation, American National Standards Institute (ANSI; “Excursions in worker exposure levels may exceed 3 e.g., laboratory decommissioning standard), Clini- times the TLV-TWA for no more than a total of 30 min- cal and Laboratory Standards Institute (e.g., clinical utes during a work day, and under no circumstances laboratory waste management), College of American should they exceed 5 times the TLV-TWA, provided Pathologists, International Association for Assess- that the TLV-TWA is not exceeded.” ment and Accreditation of Laboratory Animal Care, The action level (AL) is an OSHA regulatory concept and the National Council on Radiation Protection and applied to only a few substances. The AL is also an Measurement (e.g., radiation exposure, waste manage-

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270 PRUDENT PRACTICES IN THE LABORATORY Federal Safety Laws and Regulations That Pertain to Laboratories TABLE 11.1 Law or Regulation Citation Purpose Comments Regulation of Chemicals Used in Laboratories Occupational Safety and Health 29 USC § 651 et seq. Worker protection Act (OSHA) General duty clause 29 USC § 654(5)(a) Assurance of workplace free from Foundation enforceable requirement and (b) recognized hazards that are causing or likely in absence of a specific standard to cause serious physical harm Occupational Exposure to 29 CFR § 1910.1450 Laboratory worker protection from exposure Requires a chemical hygiene plan. Hazardous Chemicals in to hazardous chemicals Title 29 rules are written and Laboratories (Laboratory enforced by OSHA Standard) Hazard Communication 29 CFR § 1910.1200 General worker protection from chemical Requires labeling and material Standard use safety data sheets (MSDSs) Air contaminants 29 CFR §§ Standards for exposure to hazardous See section 11.C.1 for chemical- 1910.1000–1910.1050 chemicals specific regulations pertinent in laboratories Hazardous materials 29 CFR §§ Protection against hazards of compressed See also Uniform Fire Code and 1910.101–1910.111 gases, flammable and combustible liquids, National Fire Protection Association explosives, anhydrous ammonia standards OSHA Respiratory Protection 29 CFR § 1910.134 When respiratory protection is required; Standard how to fit and use respirators; and medical review Personal protective equipment 29 CFR §§ Head, hand, foot, eye, face, and respiratory See also American National 1910.132–1910.138 tract protection Standards Institute standards Control of hazardous energy 29 CFR § 1910.147 Worker protection from electrical and other (Lock out/Tag out) stored energy hazards Machinery and machine 29 CFR §§ Worker protection from mechanical hazards guarding 1910.211–1910.219 Controlled substances 21 CFR §§ Requires licenses and controls for the Enforced by the Drug Enforcement 1300-1399 purchase, use, and possession of controlled Agency substances, illicit drugs, and certain drug precursors Chemical Facility Anti- 6 CFR Part 27 Establishes risk-based performance Appendix A of the regulation Terrorism Standards (CFATS) standards for the security of chemical contains list of chemicals of interest with Appendix facilities and their threshold quantities Toxic Substances Control Act 40 CFR Part 761 Prohibition against PCBs in manufacturing, Permits certain limited laboratory (TSCA) processing, distribution in commerce, and use of PCBs certain uses Polychlorinated biphenyls (PCBs) Permit and excise tax for 27 CFR Part 211 Control of the sale of ethanol Enforced by the U.S. Bureau of purchase of 190- and 200-proof Alcohol, Tobacco, and Firearms ethanol Regulation of Biohazards and Radioactive Material Used in Laboratories Occupational exposure to 29 CFR § 1910.1030 Worker protection from exposure to bloodborne pathogens bloodborne pathogens Select agents and toxins 42 CFR Part 73 Establishes the requirements for possession, Select agents are biological agents use, and transfer of select agents and toxins. that are a terror risk. Rules are administered by the U.S. Centers for Disease Control and Prevention and the U.S. Animal and Plant Health Inspection Service

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271 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES Continued TABLE 11.1 Law or Regulation Citation Purpose Comments Atomic Energy Act 42 USC § 2073 et Establish standards for protection against See also OSHA, Ionizing Radiation Energy Reorganization Act seq. radiation hazards 42 USC § 5841 et seq. Standards for Protection Against 10 CFR Part 20 Establish exposure limits and license Title 10 rules are written and Radiation; Licenses 10 CFR Parts 30–35 conditions enforced by Nuclear Regulatory Commission Notices, Instructions, and 10 CFR Part 19 Workplace information that must be posted Reports to Workers; Inspections where radiation or radioactive materials are present Environmental Regulations Pertaining to Laboratories Resource Conservation and 42 USC § 6901 et Protection of human health and Recovery Act (RCRA) seq. environment Hazardous waste management 40 CFR Parts “Cradle-to-grave” control of chemical waste Subpart K of 40 CFR Part 262 is an 260–272 opt-in rule specific to laboratories in academia. Title 40 rules are written and enforced by EPA Clean Air Act (CAA) 42 USC § 7401 et Protection of air quality and human health seq. CAA Amendments of 1990 42 USC § 7409 et Expansion of air quality protection Requires development of specific seq. rules for laboratories National Emission Standards for 40 CFR Part 82 Control of air pollutant emissions Hazardous Air Pollutants Montreal Protocol for Protection 40 CFR Part 82 Control of emission of ozone-depleting Severely limits use of certain of Stratospheric Ozone compounds chlorofluorocarbons Federal Water Pollution Control 33 USC § 1251 et Improvement and protection of water Act seq. quality Criteria and standards for the 40 CFR Part 125 Control of discharge to public waters National Pollutant Discharge Elimination System (NPDES) General pretreatment 40 CFR Part 403 Control of discharge of pollutants to public Implemented by local sewer regulations for existing and new treatment works authorities sources of pollution Shipping, Export, and Import of Laboratory Materials Hazardous Materials 48 USC § 1801 et Control of movement of hazardous materials Transportation Act seq. Hazardous material regulations 49 CFR Parts Regulation of packaging, labeling, Standards of the International Air 100–199 placarding, and transporting Transport Agency apply to chemicals shipped by air. Title 49 rules are written and enforced by DOT. Hazardous materials training 49 CFR §§ Assurance of training for all persons Also known as HM126F requirements 172.700–172.704 involved in transportation of hazardous materials TSCA 15 USC § 2601 et Requires testing and necessary restrictions Collection and development of seq. on use of certain chemical substances information on chemicals Reporting and recordkeeping 40 CFR Part 704 One provision exempts users of small Must follow R&D exemption requirements quantities solely for research and requirements development (R&D) Significant adverse reaction 40 CFR Part 717 Record of new allegation that chemical TSCA § 8(c) substances or mixture caused significant adverse effect for health or the environment continued

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272 PRUDENT PRACTICES IN THE LABORATORY Continued TABLE 11.1 Law or Regulation Citation Purpose Comments Technically qualified individual 40 CFR § 720.3(ee) Definition of TQI by background; Follow TQI requirements with R&D (TQI) understanding of risks, responsibilities, and legal requirements TSCA exemption for R&D 40 CFR § 720.36 Exemption for R&D from PMN if chemical Follow R&D exemption substance not on TSCA inventory or is requirements including labeling and manufactured or imported only in small MSDS information quantities solely for R&D Exports of samples, chemicals, 15 CFR Parts Regulates shipments of certain chemicals These rules are administered by biologicals, other materials, and 730–774 and other research materials out the United the U.S. Department of Commerce; laboratory equipment States other export regulations may apply Regulation of Laboratory Injuries, Accidents, and Spills Recording and reporting 29 CFR Part 1904 Standards for employee reporting and occupational injuries and recordkeeping illnesses Employee emergency plans and 29 CFR § 1910.38 Requirements for written emergency and fire prevention plans fire prevention plans 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 Superfund Amendments and 42 USC § 9601 et Planning for emergencies and reporting of Title III, also known as Community Reauthorization Act (SARA) seq. hazardous materials Right-to-Know Act 42 USC § 11000 et seq. 40 CFR Part 370 (§ 311–312) 40 CFR Part 372 (§ 313) Emergency planning and 40 CFR Part 355 Requirements for reporting of extremely Applies to all chemical users notification hazardous materials and unplanned releases Hazardous Waste Operations 29 CFR § 1910.120 Worker protection during hazardous waste Applies to state and local and Emergency Response 40 CFR Part 311 cleanup government employees not covered by OSHA Other Laboratory Regulations and Standards Americans with Disabilities Act 28 CFR Part 36 Standards for making workplace accommodations for students and employees with disabilities Access to employee exposure 29 CFR § 1910.20 Employee and privacy and other rights; and medical records employer responsibilities Occupational noise exposure 29 CFR § 1910.95 Standards for noise, monitoring and medical surveillance ment). (See Chapter 10, section 10.E, for an explanation dix A. Laboratory workers and managers should read of laboratory security requirements.) and understand these regulations. Two laws that have perhaps the most impact on laboratories are the Occupational Safety and Health 11.B REGULATION OF LABORATORY Administration’s Occupational Exposure to Hazardous DESIGN AND CONSTRUCTION Chemicals in Laboratories (the OSHA Laboratory Stan- dard) and RCRA, under which EPA regulates chemical Laboratory design, construction, and renovation hazardous waste. Because of its importance, the text of are regulated mainly by state and local laws that in- the OSHA Laboratory Standard is reprinted in Appen- corporate, by reference, generally accepted standard

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273 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES practices set out in various uniform codes, such as the Chemicals Covered by Specific OSHA TABLE 11.2 International Building Code (IBC), the International Standards Fire Code (IFC), and the National Fire Protection As- 1001 Asbestos sociation standards.1 For laboratory buildings where 1002 Coal tar pitch volatiles hazardous chemicals are stored or used, detailed 1003 4-Nitrobiphenyl (and 12 related carcinogens) 1004 α-Naphthylamine requirements usually cover spill control, drainage, 1006 Methyl chloromethyl ether containment, ventilation, emergency power, special 1007 3,3′-Dichlorobenzidine (and its salts) controls for hazardous gases, fire prevention, and 1008 bis-Chloromethyl ether building height. Some localities have initiated regula- 1009 β-Naphthylamine tions aimed at increasing efficiency and sustainability 1010 Benzidine 1011 4-Aminodiphenyl in building design. These may become more common 1012 Ethyleneimine in the future, and laboratory designers may wish to 1013 β-Propiolactone consider these issues when planning new construction. 1014 2-acetylaminofluorene Building and fire codes also apply after construction 1015 4-Dimethylaminoazobenzene has been completed. These codes are typically enforced 1016 N-Nitrosodimethylamine 1017 Vinyl chloride by the fire authority having jurisdiction—usually the 1018 Inorganic arsenic local fire marshal. As explained in Chapter 6, sections 1025 Lead 6.F.5 and 6.F.7 these codes describe how flammables, 1026 Chromium VI reactives, and gases must be stored, and limit their 1027 Cadmium quantities in fire control areas. 1028 Benzene 1044 1,2-Dibromo-3-chloropropane In addition, OSHA standards affect some key labo- 1045 Acrylonitrile ratory design and construction issues, for example, 1047 Ethylene oxide eyewashes, safety showers, and special ventilation 1048 Formaldehyde requirements. Other consensus standards prepared by 1050 Methylenedianiline organizations such as ANSI and the American Society 1051 1,3-Butadiene 1052 Methylene chloride of Heating, Refrigeration, and Air Conditioning Engi- neers are relevant to laboratory design. It is not uncom- Each standard is in 29 CFR § 1910.XXXX, where XXXX is the mon for various codes and consensus standards to be section number that precedes the chemical name: incorporated into state or federal regulations. cal surveillance, and routine air monitoring of your 11.C REGULATION OF CHEMICALS workplace. For more information, see 29 CFR Part USED IN LABORATORIES 1910 as well as in specific standards following section OSHA and EPA regulation of chemical use in labo- 1910.1000, such as the vinyl chloride standard, 29 CFR ratories is described below. The laboratory use of § 1910.1017, which prohibits direct contact with liquid controlled substances, regulated by the U.S. Drug vinyl chloride. Enforcement Agency, is described in Chapter 10, sec- Other OSHA standards setting forth PELs apply tion 10.E.4.1. Select agent toxins are regulated by the to the extent that they require limiting exposures to Centers for Disease Control and Prevention (CDC) and below the PEL, and, where the PEL or AL is routinely the U.S. Department of Agriculture Animal and Plant exceeded, the Laboratory Standard’s provisions (de- Health Inspection Service (APHIS). scribed below) require exposure monitoring and medi- cal surveillance (see Appendix A, sections (d) and (g)). If you use these chemicals routinely, even for short 11.C.1 OSHA Standards for Specific periods of time, you should have your workplace Chemicals evaluated by your EHS officer to ensure that your OSHA has developed comprehensive standards for work practices and engineering controls are sufficient several chemicals, which are listed in Table 11.2. To pre- to keep your exposures below the OSHA-specified vent exposure to personnel, these standards cover all limits. Because of their common use in campus labora- aspects of the use of these chemicals. These standards tories, the specific standards for formaldehyde (used as are above those required by the Laboratory Standard formalin for preservation of tissue samples), benzene, and, in some cases, may require special signs, medi- and ethylene oxide are of particular concern. 1In 2003, the Building Officials and Code Administrators Interna- 11.C.2 The OSHA Laboratory Standard tional, Inc., the International Conference of Building Officials, and the Southern Building Code Congress International, Inc. formed the In 1990, OSHA promulgated its Laboratory Standard International Code Council. This body now publishes both the IFC (Occupational Exposure to Hazardous Chemicals in and the IBC among other documents.

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274 PRUDENT PRACTICES IN THE LABORATORY Laboratories, 29 CFR § 1910.1450; see Appendix A). In employee information and training requirements of the brief, the OSHA Laboratory Standard requires organi- Laboratory Standard. zations to 11.C.2.1 The Chemical Hygiene Plan 1. Keep laboratory personnel exposures to chemi- cals below OSHA’s PELs. The centerpiece of the Laboratory Standard is the 2. Write a Chemical Hygiene Plan. Chemical Hygiene Plan. This is a written plan de- 3. Designate a Chemical Hygiene Officer to imple- veloped by employers. It has the following major ment the plan. elements: 4. Train and inform new laboratory personnel of • the OSHA Laboratory Standard, • employee information and training about the haz- • the Chemical Hygiene Plan and its details, ards of chemicals in the work area, including how • OSHA’s PELs, to detect their presence or release, work practices • the signs and symptoms of exposure to haz- and how to use protective equipment, and emer- ardous chemicals, gency response procedures; • MSDSs, • circumstances under which a particular labora- • Prudent Practices in the Laboratory, tory operation requires prior approval from the • methods to detect the presence of hazardous employer; chemicals, • standard operating procedures for work with • the physical and health hazards of the chemi- hazardous chemicals; cals, and • c riteria for use of control measures, such as • m easures to protect laboratory personnel e ngineering controls or personal protection from chemical hazards. equipment; 5. I n certain circumstances, provide laboratory • measures to ensure proper operation of fume personnel access to medical consultations and hoods and other protective equipment; examinations. • provisions for additional employee protection for 6. Keep labels of supplied chemicals intact. work with “select carcinogens” (as defined in the 7. M aintain the MSDSs for all your supplied Laboratory Standard) and for reproductive toxins chemicals. or substances that have a high degree of acute 8. For chemical substances developed in your labo- toxicity; ratory, train laboratory personnel as described • provisions for medical consultations and exami- above. nations for employees; and 9. Use respirators properly. • designation of a Chemical Hygiene Officer. It is important to understand that the OSHA PELs Section 2.B of Chapter 2 describes additional ele- and substance-specific standards do not include all ments, not required by law, that may be added to a hazardous chemicals. It is the laboratory manager’s Chemical Hygiene Plan. responsibility under the Laboratory Standard and its Some firms and institutions have developed a single general duty clause to apply scientific knowledge in generic Chemical Hygiene Plan for the entire organi- safeguarding workers against risks, even though there zation. To be most effective, however, the plan should may be no specifically applicable OSHA standard. In include detailed protections that are specific to each circumstances where exposure limits are exceeded or laboratory, project, experiment, procedure, and worker. where work with particularly hazardous substances is Laboratory-specific plans allow considerable flexibility conducted, laboratories must keep records of exposure in achieving the performance-based goals of the Labo- monitoring and medical surveillance. ratory Standard. Model Chemical Hygiene Plans are The Laboratory Standard refers to the National available from your state OSHA consultation service Research Council’s Prudent Practices for Handling Haz- or the American Chemical Society. ardous Chemicals in Laboratories (NRC, 1981) as “non- mandatory . . . guidance to assist employers in the de- 11.C.2.2 Particularly Hazardous Substances velopment of the Chemical Hygiene Plan.” One of the most common Laboratory Standard There are special provisions in the Laboratory Stan- OSHA citations has been for failure to have a Chemi- dard regarding work with “particularly hazardous cal Hygiene Plan or for missing an element in the plan. substances,” a term that includes “select carcinogens,” Another commonly cited violation is failure to meet the

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275 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES “reproductive toxins,” and “substances with a high provisions are to be included in the Chemical Hygiene degree of acute toxicity.” Plan. • A select carcinogen is defined in the standard as any 11.C.3 Chemical Facility Anti-Terrorism substance (1) regulated by OSHA as a carcinogen; Standards (2) listed as “known to be a carcinogen” in the Report on Carcinogens published by the National In 2007, Congress authorized DHS to “establish Toxicology Program (HHS/CDC/NTP, 1995); (3) risk-based performance standards for security chemi- listed under Group 1 (“carcinogenic to humans”) cal facilities.” In response, DHS issued the Chemical by the International Agency for Research on Cancer Facility Anti-Terrorism Standards (CFATS). According (IARC) Monographs; or (4) in certain cases, listed in to the agency, the standards identify high-risk facilities either Group 2A or 2B by IARC or under the cat- based on the likelihood of an attack, the consequences egory “reasonably anticipated to be carcinogens” of an attack, and the threat of an attack based on the by NTP. A category (4) substance is considered a intent and capability of an adversary. The standards select carcinogen only if it causes statistically sig- are concerned with nificant tumor incidence in experimental animals in accordance with any of the following criteria: • EPA Risk Management Plan chemicals, (1) after inhalation exposure of 6 to 7 hours per • highly toxic gases, day, 5 days per week, for a significant portion of a • chemical weapons convention chemicals, and lifetime to dosages of less than 10 mg/m3; (2) after • explosives. repeated skin application of less than 300 mg/kg of body weight per week; or (3) after oral dosages The specific “Chemicals of Interest” are listed in Ap- of less than 50 mg/kg of body weight per day. pendix A of the CFATS rule. (See Chapter 10, section • “Reproductive toxins” are defined as those chemi- 10.E.4.2 for examples.) The standard applies to any cals that affect reproductive capabilities, including institution that meets or exceeds the threshold quantity chromosomal damage (mutations) and effects on established for these chemicals. All facilities, includ- fetuses (teratogenesis). ing those with laboratories, are expected to survey • Chemicals with a “high degree of acute toxicity” are their site for the presence of the chemicals of interest highly toxic noncarcinogenic or highly volatile and compare the inventory to the threshold screening toxic materials that may be fatal or cause damage quantities established in Appendix A of the standard. to target organs as a result of a single exposure If the facility meets or exceeds the threshold quantity or exposures of short duration. Examples include for any chemical of interest, the facility must report the hydrogen sulfide, nitrogen dioxide, hydrogen inventory to DHS. cyanide, and methylmercury. On the basis of the report, chemical facilities are categorized into risk-based tiers. Each facility is as- Although “select carcinogens” are specifically iden- signed a tier ranging from tier 1 (highest risk) to tier 4 tified through reference to other publications, “repro- (lowest risk). Facilities that fall into risk tiers 1–3 must ductive toxins” and chemicals with a ‘’high degree prepare a security vulnerability assessment (SVA) to of acute toxicity” are not specified further, which has identify facility security vulnerabilities, and develop made it difficult to apply these categories. Some or- and implement site security plans. Should a facility ganizations have chosen to adopt the OSHA Hazard fall into tier 4, circumstances may allow for submission Communication Standard definition of “highly toxic” of alternate security programs in lieu of an SVA, a site (LD50 < 50 mg/kg oral dose) as a workable definition of security plan, or both. high degree of acute toxicity. There is little agreement For more information about SVAs and CFATS, see on how to determine reproductive toxins. Chapter 10, sections 10.F and 10.E.4.2. The OSHA-mandated special provisions for work with carcinogens, reproductive toxins, and substances 11.C.4 Regulations Covering that have a high degree of acute toxicity include con- Polychlorinated Biphenyls (PCBs) sideration of “designated areas,” use of containment devices, special handling of contaminated waste, and Regulations pursuant to the Toxic Substances Con- decontamination procedures. The OSHA requirement trol Act (TSCA) apply to the use of PCBs and monochlo- is for evaluation, assessment, and implementation of robiphenyls in laboratories. Although the rules except these special controls, when appropriate. These special the use of “small quantities for research and develop- ment” and use “as an immersion oil in microscopy,”

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276 PRUDENT PRACTICES IN THE LABORATORY researchers contemplating work with PCBs (including RCRA, EPA is given great responsibilities in promul- environmental studies with PCB-contaminated media) gating detailed regulations governing the generation, should consult their institution’s EHS officer because transport, treatment, storage, and disposal of hazard- of the stringency of these regulations. ous (chemical) waste. RCRA and EPA regulations apply to laboratories that use chemicals. 11.D REGULATION OF BIOHAZARDS AND RADIOACTIVE MATERIALS 11.E.1.1 Definitions and Types of Hazardous USED IN LABORATORIES Waste Generators As explained in Chapter 4, sections 4.H, and Chap- A generator is any firm or institution whose pro- ter 6, section 6.E.2, most radioactive materials that are cesses and actions create hazardous waste. There are used in laboratories are regulated by the U.S. Nuclear three categories of generator: Regulatory Commission (USNRC). Rules most perti- nent to laboratories are in Title 10 of the Code of Federal 1. L arge-quantity generators a re those whose Regulations, Parts 20 and 30. The USNRC licenses the facilities generate 1,000 kg or more per month use of radioactive materials. Many institutions and (about four 55-gal drums of hazardous waste) firms obtain a broadscope license from the NRC, or over 1 kg of “acutely hazardous waste” per which provides flexibility but requires an institu- month. By this measure, most large research tional Radiation Safety Officer and Radiation Safety organizations, including the larger universities, Committee. are large-quantity generators. As explained in Chapter 4, section 4.G, and Chapter 2. Generators of more than 100 but less than 1,000 6, section 6.E.1, the most widely accepted standards kg of hazardous waste per month, and less than for using biohazards in laboratories can be found in 1 kg of “acutely hazardous waste” per month (and accumulate less than 1 kg at any one time). Biosafety in Microbiological and Biomedical Laboratories (BMBL; HHS/CDC/NIH, 2007a). The Foreword ex- This category may not accumulate more than plains that, “the BMBL remains an advisory document 6,000 kg at any one time. recommending best practices for the safe conduct of 3. Conditionally exempt small-quantity genera- work in biomedical and clinical laboratories, from a tors of 100 kg or less of hazardous waste per biosafety perspective and is not intended as a regula- month and less than 1 kg of “acutely hazardous tory document.” However, many accrediting bodies, waste.” The special requirements applicable to grant-making organizations, and state regulators ex- conditionally exempt small-quantity generators pect laboratories that use biohazards to adhere to the can be found in 40 CFR § 261.5. BMBL. Select agents are regulated by CDC and the Depart- 11.E.1.2 Implications of EPA’s Definition of ment of Agriculture’s APHIS. On-Site Federal and state definitions of on-site have bearing 11.E ENVIRONMENTAL REGULATIONS on the generation category of each site, and how labo- PERTAINING TO LABORATORIES ratory hazardous waste is transported and managed. Federal and state environmental regulations apply This is particularly important for firms, colleges, uni- to laboratory waste, air emissions, and discharges to versities, and other organizations that are transected the sewer. Of these, EPA’s rules for chemical hazardous by public roads. waste may be the most demanding. “Individual generation site” is defined by RCRA regulation as a contiguous site at or on which hazard- ous waste is generated. A firm or institution located in 11.E.1 Management of Chemical one geographic area may be viewed as a single genera- Hazardous Waste tor with a single EPA generator identification number Chapter 8 covers the regulation of chemical hazard- or, if it is transected by public roads, may be viewed ous waste in laboratories, while this section covers the as multiple generator sites requiring multiple EPA gen- regulation of that waste at an institutional level. erator identification numbers. Multisite facilities are RCRA was enacted by Congress in 1976 to address required to have separate EPA identification numbers the problem of improper management of hazardous for each site. waste. Subtitle C of that Act established a system for Note that each individual laboratory generating controlling hazardous waste from generation to dis- waste is not itself a RCRA “generator,” but instead is posal, often referred to as “cradle to grave.” Under part of the “generator” site. Each laboratory therefore

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277 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES must comply with the requirements applicable to the 11.E.1.4 RCRA Waste Minimization Requirements site’s generator category. Generators are required to certify on the manifest RCRA defines “on-site,” as “the same or geographi- accompanying off-site shipment of waste that they cally contiguous property which may be divided by have a waste minimization program. Guidelines for a public or private right-of-way, provided the entrance waste minimization program are available from EPA. and exit between the properties is at a crossroads in- By signing the manifest, the generator is certifying the tersection, and access is by crossing as opposed to going following: along [emphasis added] the right-of-way.” Large-Quantity Generators: “I have a program in The significance of this definition is that, with one place to reduce the volume and toxicity of waste gen- exception, hazardous waste that is being transported erated to the degree I have determined to be economi- on public roads can be sent only to a permitted treat- cally practicable and I have selected the practicable ment, storage, and disposal facility (TSDF). The excep- method of treatment, storage, or disposal currently tion [in 40 CFR § 262.20 (f)] explains that this restriction available to me which minimizes the present and future does “not apply to the transport of hazardous wastes threat to human health and the environment.” on a public or private right-of-way within or along the Small-Quantity Generators: “I have made a good border of contiguous property under the control of faith effort to minimize my waste generation and select the same person, even if such contiguous property is the best waste management method that is available to divided by a public or private right-of-way.” me and that I can afford.”2 In all other cases, hazardous waste cannot be trans- ported on public roads to an unpermitted holding facil- ity, even if the public road and the receiving location 11.E.1.5 Transportation of Chemicals and are within the boundaries of an institution. Hazardous Waste For organizations whose laboratory operations are at a single site, transportation within that site is not 11.E.1.3 Minimum Requirements for Generators regulated, as long as that transport involves no travel Generators must obtain an EPA identification num- along public ways. Most organizations, however, have ber, prepare the waste for transport, follow accumula- developed policies for on-site transport covering label- tion and storage requirements, manifest hazardous ing, segregation of incompatibles, containment and waste, and adhere to detailed record-keeping and double containment, and other necessary safeguards to reporting requirements. At most firms and institu- prevent accidental release to the environment or injury tions, hazardous waste is shipped off-site, treated, to persons during transportation. stored, and disposed of at commercial EPA-permitted As with hazardous materials, off-site transportation TSDFs. Note that generators producing more than 1 kg of hazardous waste is regulated by DOT in accordance in a calendar month of “acute hazardous waste” (see with the Hazardous Materials Transportation Uniform above) are subject to full regulation under RCRA as a Safety Act. These regulations apply not only to those large-quantity generator. who actually transport, but also to those who initiate Although conditionally exempt small-quantity gen- or receive hazardous waste shipments. DOT regula- erators are partially exempt from these requirements, tions applicable to transport of laboratory chemicals they must still include those governing packaging, labeling, marking, placarding, and reporting of discharges. Those who • identify their waste to determine whether it is prepare hazardous materials for transportation must hazardous, also meet certain training requirements. • not accumulate more than 1,000 kg of hazardous Under the DOT Materials of Trade exception, fa- waste, and cilities may transport their own chemicals to another • ensure that the waste is sent to a permitted TSDF facility owned by the same organization under certain or a recycling facility. conditions. This exemption also applies to transport for the purpose of chemical demonstrations, such as at a Note that state laws may differ. For example, some local high school or as part of a special event. All chemi- states regulate all generators of hazardous waste with cals must be properly packaged in DOT-specification no exemptions, and some states regulate chemical containers. Hazardous waste may not be transported wastes that are not included in RCRA (e.g., used oil, as a Material of Trade. as hazardous waste). As explained in Chapter 8, section 8.B.7, EPA’s RCRA See Chapter 8, section 8.B.4 for a detailed expla- rules include additional requirements for transporta- nation of hazardous waste collection and storage requirements. 2From 40 CFR § 262.27(a).

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278 PRUDENT PRACTICES IN THE LABORATORY tion of hazardous waste. Detail of the many require- some states have set emission limits that apply to labo- ments for transporting hazardous waste is beyond the ratories, or require permits for laboratory hoods. Check scope of this book. with your state environmental agency to determine if there are specific air emission requirements for your laboratory. 11.E.2 Management of Radioactive and Biohazardous Waste 11.F SHIPPING, EXPORT, AND IMPORT Disposal of low-level radioactive waste from labo- OF LABORATORY MATERIALS ratories is governed by USNRC rules in Title 10 of the Code of Federal Regulations , Parts 20 and 30, as Shipping, export, and import laws strictly regulate well as conditions specified in institutional licenses. the domestic and international transport of an ex- Short-half-life radwaste is typically held for decay in tensive list of laboratory materials, including many storage, and then disposed of without regard to its chemicals, vaccines, genetic elements, microbiologi- radioactivity. cal agents, radioactive materials, and a wide array of Federal laws that regulate laboratory biohazardous research equipment, technologies, and supplies. Many and infectious waste are limited. Most important are items that are not perceived to be particularly hazard- the OSHA bloodborne pathogen standard, DOT rules ous, valuable, or uncommon are nevertheless subject for transporting biomedical waste, and EPA medi- to export control laws and shipping regulations. Ex- cal waste incineration rules. The OSHA bloodborne port and import laws may require special licenses or pathogen standard addresses the collection and man- permits prior to leaving or entering the United States. agement of needles, blades, and other sharps. Most Regulated activities include conveying laboratory states regulate the treatment and disposal of labora- materials via tory biohazardous waste; consult your state laws for specific requirements. • shipments and mailings using the U.S. Post Office and other mail couriers; • receiving or sending regulated materials by any 11.E.3 Discharges to the Sewer method of transport; Contact your local publicly owned treatment works • shipments to (exporting) or from (importing) a (POTW) for rules on discharges to the sanitary sewer. foreign country; Your POTW is the best source for information about • transporting any amount of regulated material in limits and prohibitions for the discharge of laboratory a commercial aircraft, whether on your person or wastewaters that contain chemicals, biologicals, or in carry-on luggage or checked luggage. radioactive materials. Federal rules exist that pertain to the discharge of hazardous waste and radioactive The many laws for shipping laboratory materials materials, but those limits are usually incorporated in are described below, including regulations from the POTW ordinances. U.S. Department of Commerce (DOC), DOT, and EPA. Although these rules are described individually, please note that several regulations often apply to a single 11.E.4 Air Emissions from Laboratories shipment. The Clean Air Act (CAA) regulates emissions into In addition to these requirements, your institution the air. Laboratories should be aware of the regulations may have entered into a Material Transfer Agreement, that control stratospheric-ozone-depleting substances. which controls any transfer of the research materials The list of such substances can be found in 40 CFR Part from your institution to another. 82, Appendixes A and B to Subpart A. The list includes See Chapter 5, section 5.F for practical, nonlegal in- as “Class I” substances most common freons, carbon formation about shipping laboratory materials. tetrachloride, and methyl chloroform. Under the CAA, EPA also sets national emission 11.F.1 General Shipping Regulations standards for hazardous air pollutants (NESHAPs). NESHAPs for radionuclides and sterilants have been Regulations on the transportation of hazardous established, and these may apply to some laboratories. materials are aimed at ensuring that the public and EPA has not established emission standards for volatile the workers in the transportation chain are protected organic compounds or other emissions from laboratory from exposure to potentially hazardous materials be- operations, nor has EPA established a special source ing transported. Protection is achieved through the category for research or laboratory facilities. However, following requirements:

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279 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES • rigorous packaging that will withstand rough 11.F.2.1 TSCA Research and Development handling and contain all liquid material within Exemption the package without leakage to the outside, TSCA includes a “Research and Development (R&D) • appropriate labeling of the package to alert the Exemption” which greatly reduces requirements for workers in the transportation chain to the hazard- laboratories, but does not eliminate them. Under the ous contents within, R&D Exemption, laboratory chemicals are exempted • documentation of the hazardous contents within from many TSCA requirements if they are the package and emergency contact information in the event of an emergency with the package, • imported, manufactured, or used in small quanti- and ties (“not greater than reasonably necessary for • training of workers in the transportation chain to such (R&D) purposes”); and familiarize them with the hazardous contents so • solely for purposes of noncommercial scientific as to be able to respond to emergency situations. experimentation, analysis, or research, and • under the supervision of a technically qualified DOT is the national authority that regulates the individual. shipment and transport of hazardous material. DOT regulations governing hazardous materials transport To maintain this exemption status, laboratories are detailed in Title 49 of the Code of Federal Regulations, engaged in R&D must keep records of allegations of Parts 171–178. adverse reactions and discovery of substantial risk. Technical Instructions for the Safe Transport of Danger- Also, chemical imports need to be certified in writing, ous Goods by Air, published by the International Civil and certain chemical exports require notification of the Aviation Organization (ICAO), are the legally binding receiving countries. international regulations. Annually, the International Air Transport Association (IATA) publishes Dangerous Goods Regulations (DGR) that incorporates the ICAO 11.F.2.2 TSCA Record-Keeping Requirements for provisions and may add further restrictions. The ICAO R&D Laboratories rules apply on all international flights. For national For R&D laboratories, TSCA is primarily an admin- flights (i.e., flights within one country), national civil istrative, records-intensive program. Establish a TSCA aviation authorities apply national legislation. This compliance file to log significant adverse effects, file is normally based on the ICAO provisions, but may reports of substantial risks, and document imports incorporate variations. State and operator variations and exports. are published in the ICAO Technical Instructions and Under TSCA § 8(c), laboratories are required to keep in the IATA DGR. records of allegations of significant adverse effects from R&D chemicals. For example, laboratories must create and maintain records of allegations of, for example, a 11.F.2 EPA Requirements for Chemical skin rash, allergic reaction, or respiratory effect that Export and Import may be attributable to exposure to an R&D chemical. TSCA, administered by EPA, was established to en- Laboratories must also document the discovery of sure that the human health and environmental effects any significant risks to human health or the environ- of chemical substances are identified and properly con- ment potentially associated with R&D substances. In- trolled prior to placing these materials into commerce. clude this report in your TSCA compliance file. Chemical substances regulated by TSCA include, Your file should also contain TSCA import and “Any organic or inorganic substances of a particular export certifications, as described below. Copies of molecular identity including any combination of such the written notifications provided (i.e., the letter, the substances occurring, in whole or in part, as a result MSDS, and copies of all labels affixed to sample con- of chemical reaction or occurring in nature and any tainers) should be maintained in a file for 5 years. element or uncombined radical.” Chemical substances not regulated or excluded by TSCA include pesticides regulated by the Federal Insecticide, Fungicide, and 11.F.2.3 Chemical Exports from R&D Laboratories Rodenticide Act; tobacco and tobacco products regu- Laboratories must complete and send to EPA a TSCA lated by the Bureau of Alcohol, Tobacco, Firearms, Export Notification Form prior to the exportation of and Explosives; radioactive materials regulated by chemical substances listed in the EPA’s Chemicals on the USNRC; and foods, food additives, drugs, and Reporting Rule (CORR) Database. Sample forms, the cosmetics or devices regulated by the Food and Drug CORR Database, and EPA submission instructions Administration.

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280 PRUDENT PRACTICES IN THE LABORATORY are available via the Web (search for “TSCA Export 11.F.2.6 Nanomaterials Under TSCA Certification Form,” “EPA CORR Database” and “EPA In January 2008, EPA issued “TSCA Inventory Sta- TSCA Exports”). tus of Nanoscale Substances—General Approach,” Copies of this form must be kept in lab records for which describes the agency’s perspective on whether 3 years. nanomaterials are required to be registered under An export notification is not required for R&D TSCA. EPA uses “molecular identity” to determine if a chemicals not listed in the CORR Database. chemical substance is new. Substances are said to have different molecular identities if they 11.F.2.4 TSCA Requirements for Other Chemical • have different molecular formulas, Shipments • have the same molecular formulas but different For shipments of R&D chemicals to locations within atom connectivities, the United States, TSCA requires that laboratories • have the same molecular formulas and atom con- nectivities but different spatial arrangements of • Label the containers, shipping containers, and atoms, shipping papers with “This material is not listed • have the same types of atoms but have different on the TSCA Inventory. It should be used for crystal lattices, research and development purposes only under • are different allotropes of the same element, or the direct supervision of a technically qualified • have different isotopes of the same elements. individual.” • Prepare and include an MSDS for the substance. Differences in physical characteristics such as par- This MSDS should evaluate and communicate ticle size and shape are not considered part of a risks of the substance. On the “composition, in- substance’s molecular identity. Thus, EPA states, “a formation on ingredients,” section of the MSDS, nanoscale substance that has the same molecular iden- indicate, “This material is for R&D evaluation tity as a substance listed on the TSCA Inventory . . . is only. It can only be used for R&D evaluations considered an existing chemical, i.e., the nanoscale and until PMN review by EPA is completed. If this non-nanoscale forms are considered the same chemi- material is used in plants or non-R&D locations cal substances because they have the same molecular for R&D evaluation, its use must be supervised identity” (EPA, 2008). by a technically qualified individual. Review all Regulatory controls on nanomaterials will likely sections of this MSDS prior to use.” Alternatively, change as the field develops, and it is important for this information may be included on the shipment researchers and organizations to monitor this area. form. To assist with future regulatory questions regarding nanomaterials, EPA has created the Nanoscale Ma- If an R&D-exempt chemical is transferred to a pilot terials Stewardship Program. Those who work with plant or manufacturing plant, see EPA rules for the ad- nanomaterials should also be aware of international ditional requirements. efforts through the International Organization for Stan- dardization and others to develop standards, testing, health and safety practices, etc. and may affect future 11.F.2.5 Chemical Imports from R&D Laboratories regulations. Laboratories must complete the TSCA Import Cer- tification Form for all R&D samples and chemicals re- 11.F.3 Requirements for Biological Export ceived from a foreign country. There are no exceptions and Import to this requirement. Sample forms are available via the Web (search for Laboratories that export or import infectious sub- “TSCA Import Certification Form”), chemical supply stances, related biological substances, and/or materials vendors, or customs brokers. Unless the imported that may contain infectious substances should be aware chemical is excluded (see above), check “Positive Cer- of the following regulatory programs: tification” on the Form. Provide this form to the mail or express delivery service or customs broker prior to • Infectious Substance (human pathogens) Import the import date. Keep a copy in your TSCA compliance Permit Program (U.S. Department of Health and file for 3 years. Human Services, U.S. Public Health Service, CDC, 42 CFR Part 71);

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281 SAFETY LAWS AND STANDARDS PERTINENT TO LABORATORIES • Animal Pathogens and Related Biological Materi- as are provided to all employees regularly working in als Import Permit Program (USDA APHIS); the laboratory. • Importing a Plant Pathogen or Plant Product (USDA/APHIS Plant Protection and Quarantine 11.G.2 Planning for Chemical Emergencies PPQ, 7 CFR Part 330); and • U.S. Fish and Wildlife and CITES Endangered Title III of the Superfund Amendments and Reau- Species Permits (Convention on International thorization Act (SARA Title III) was passed in 1986 to Trade in Endangered Species). facilitate planning for chemical emergencies. One pro- vision of the law requires that any institution with an EPA-listed “extremely hazardous substance” on-site in 11.F.4 Other Export Regulations greater than its “threshold planning quantities” must Scientists who ship or carry a research material notify emergency response authorities. The quantity oversees may be subject to the export licensing require- limits are based on the total quantity of the hazardous ments of DOC. chemical present at the facility rather than in an indi- DOC’s Export Administration Regulations (EAR) vidual laboratory. require licenses for the export of a wide variety of re- SARA Title III also requires facilities that use hazard- search materials. These materials (including chemicals ous chemicals to submit copies of the MSDSs used in and laboratory equipment) are classified and assigned their operations and report inventories of hazardous an Export Control Classification Number. (On the Web, chemicals. Research and clinical laboratories are ex- search “ECCN List” for examples of regulated exports.) empt from these requirements because the law defines The type of material, the destination, and the pro- “hazardous chemical” to exclude any chemical, “to the posed recipient are all subject to approval by the DOC extent it is used in a research laboratory or hospital or Bureau of Industry and Security, who issues (or may other medical facility under the direct supervision of a deny) the license. If any of these elements (material, technically qualified individual.” Note that some states destination, and recipient) are under the control of the require chemical inventories or release notification for EAR, then an export license will be required. laboratories regardless of SARA exemptions. 11.G LABORATORY ACCIDENTS, SPILLS, 11.G.3 Notification Requirements for RELEASES, AND INCIDENTS Spills, Releases, and Other Emergencies Chapter 3 describes laboratory emergency planning and response. This section describes legal requirements SARA Title III also requires that accidental releases for incidents that may occur in a laboratory. be reported to emergency planning authorities. This emergency notification requirement applies to all facilities, including research laboratories, hospitals, 11.G.1 Laboratory Injuries and Illnesses and other medical facilities. A firm or institution must Immediately report all laboratory injuries and ill- notify state and community authorities in the event nesses to your firm or institution’s appropriate office of a release into the environment of a “hazardous (e.g., Workers’ Compensation, Risk Management, substance” or an “extremely hazardous substance” in EHS), even if consultation with a medical professional excess of EPA-established “reportable quantities.” is not deemed necessary. OSHA requires tracking and Also be sure to determine the additional emergency reporting of workplace injuries and accidents. State reporting requirements of your state and locale. workers’ compensation laws detail procedures, provi- sions, employer responsibilities, and employee rights 11.G.4 Emergency Training and Response when dealing with workplace injuries and medical care. Your EHS officer should also be informed of any OSHA’s standard for hazardous waste operations near misses, spills, releases, accidents, and incidents and emergency response (29 CFR § 1910.120) estab- so that they can be investigated and safety problems lishes criteria for training, worker protection, and are corrected. cleanup of spills and releases to the environment. This OSHA standards and workers’ compensation laws standard is an excellent reference for planning your re- apply only to “employees” of laboratory facilities. Un- sponse to laboratory spills and releases. This standard paid students are not employees within the scope of must be followed by spill response contractors and the Occupational Safety and Health Act, but both moral fire departments when they respond to a laboratory and legal considerations suggest that colleges and emergency involving hazardous materials. universities provide the same protections to students In most cases, however, the immediate, simple

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282 PRUDENT PRACTICES IN THE LABORATORY cleanup of a spill by laboratory staff is not subject to sure) are not considered to be emergency responses.” this requirement. According to 29 CFR § 1910.120(a)(3), It is important that facilities have a clear understand- “Responses to incidental releases of hazardous sub- ing of the circumstances under which employees are stances where the substance can be absorbed, neutral- expected to respond to incidents, and train employees ized, or otherwise controlled at the time of release by to be able to identify the difference between a routine employees in the immediate release area, or by main- incidental release and an emergency requiring outside tenance personnel are not considered to be emergency assistance. responses within the scope of this standard.” That OSHA’s bloodborne pathogen standard describes section goes on to say, “Responses to releases of haz- the necessary precautions for cleaning a spill of human ardous substances where there is no potential safety or blood or body fluids. health hazard (i.e., fire, explosion, or chemical expo-