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National Research Council (US) Committee on Prudent Practices in the Laboratory. Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards: Updated Version. Washington (DC): National Academies Press (US); 2011.

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Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards: Updated Version.

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11Safety Laws and Standards Pertinent to Laboratory

11.A. INTRODUCTION

There are a number of federal, state, and local laws, regulations, ordinances, and standards that pertain to the laboratory activities and conditions that affect the environment, health, and safety. These are reviewed briefly in this chapter. For safety laws and standards described in detail elsewhere in this book, this chapter will refer to that section.

Laws, rules, regulations, and ordinances are created and enforced by federal, state, and local governments. International regulations apply to air and marine transport of laboratory materials. Safety standards and codes are created by nongovernmental bodies, but are important to know because they may be required by a law (by reference), as condition of occupancy, by your insurance company, by an accrediting body, or as a widely accepted industry standard. In some cases, following a safety guideline is a condition of receiving a research grant.

Please note that this chapter is not meant to be a compliance guide. This chapter only provides an overview of certain laws. Further, this chapter mostly focuses on federal requirements. State and local requirements may be more stringent, so be sure to check to determine the specific rules that apply.

11.A.1. Making Safety Laws and Their Rationale

Organizations that handle chemicals in laboratories should participate in the regulatory process so that regulators will understand the impact that proposed rules can have on the laboratory environment. The best way to provide input to this process is through dialogue with the regulators, which can take place directly or in collaboration with the institution's environmental health and safety (EHS) or governmental relations office. Also, professional associations, such as the American Chemical Society (ACS), the American Industrial Hygiene Association (AIHA), the American Conference of Governmental Industrial Hygienists (ACGIH), and the American Institute of Chemical Engineers (AIChE), as well as trade associations such as the American Chemistry Council (ACC) and the Campus Health Safety and Environmental Management Association (CHSEMA), 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 by visiting thomas.loc.gov, the Web site for the legislative search engine at the Library of Congress, or 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 title and section 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 major federal agencies involved in regulation of laboratory chemicals are the U.S. Occupational Safety and Health Administration (OSHA), the U.S. Environmental Protection Agency (EPA), the U.S. Drug Enforcement Agency, the U.S. Department of Homeland Security (DHS), and the U.S. Department of Transportation (DOT). Proposed regulations are published in the Federal Register, a daily publication of federal agency activities. Typically, 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; for example, 40 CFR Parts 260–272 is the citation for RCRA's hazardous waste rules.

It is helpful to understand the rationale that underlies EHS laws and regulations. These laws reflect congressional, state, and local legislative concerns about worker safety, human health, and the environment, and enjoy strong public support.

Regulations and compliance with them is complicated by the fact that it is a virtual impossibility for EHS 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, regulators attempt to strike a balance by regulating classes of hazards and risks.

Those managing and working in laboratories should also recognize that violation of EHS laws and regulations not only may pose unnecessary risks to those in the laboratory and the surrounding community, but also can result in significant civil penalties (at publication of this book, some laws allow maximum fines of more than $30,000 per day per violation), as well as criminal penalties. Violations can erode community confidence in an institution's seriousness of purpose in safeguarding the environment and complying with the law. Prudent practice requires not only scientific prudence, but also prudent behavior in terms of preventing the risks of noncompliance, adverse publicity, and damage to public trust and an institution's community support.

11.A.2. OSHA and Laboratories

It is important to understand the relationships between the regulations and standards that mediate laboratory activities. The OSHA Laboratory Standard (Occupational Exposure to Hazardous Chemicals in Laboratories, 29 CFR § 1910.1450) is the primary regulation, but laboratory personnel and EHS staff should understand its relationship to the hazard communication standard. In addition, the general duty clause is often invoked, and OSHA standards not written specifically for laboratories may also apply. Laboratory personnel also need to know the relationship between OSHA's permissible exposure limits (PELs), ACGIH threshold limit values (TLVs), and the National Institute of Occupational Safety and Health (NIOSH) recommended exposure limits (RELs).

11.A.2.1. OSHA Enforcement and State OSHA Laws

Enforcement of OSHA standards (such as the Laboratory Standard), 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 safety and health 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 EHS office at each institution should have a copy of the applicable standard.

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

Another important point to understand about OSHA and laboratories is that although the Laboratory Standard supersedes existing OSHA health standards, 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.

11.A.2.3. Laboratory Standard Versus Hazard Communication Standard

As noted above, the Laboratory Standard is intended, with limited exceptions, to be the primary 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….”

Custodial and maintenance staff who service the laboratory continue to be governed by the Hazard Communication Standard and other OSHA standards, which set forth the information, training, and health and safety protections required to be provided to non-laboratory employees.

Many organizations, faced with the difficulty of designing EHS programs that meet both 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 EHS program.

11.A.2.4. PELs, TLVs, and RELs

OSHA has developed PELs for chemicals. These are enforceable regulatory limits for the air concentration of individual substances to which a worker may be exposed. Many PELs are based on TLVs, which are nonregulatory exposure limits prepared by ACGIH using existing published, peer-reviewed scientific literature. Quoting the TLV booklet (ACGIH, 2009), “The TLVs … represent conditions under which ACGIH believes that nearly all workers may be repeatedly exposed without adverse health effects. They are not fine lines between safe and dangerous exposures, nor are they a relative index of toxicology.” PELs and TLVs are average concentrations for a normal 8-hour workday and a 40-hour workweek. This time-weighted average (TWA) approach to evaluating airborne contaminant exposure means that some periods of the day may have higher or lower exposures than others, reflecting the variability in most work with chemicals.

For a small number of compounds, both OSHA and ACGIH have also established a short-term exposure limit (STEL), a concentration considered safe for no more than four 15-minute periods a day. STELs are published only for compounds where toxic effects have been reported from high-level, short-duration exposures in humans or animals. In addition, both groups have also established ceiling limits for some compounds (indicated by a “C” preceding the TLV or PEL value). The ceiling limit is the concentration that should not be exceeded during any time portion of exposure. 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 (AL) is an OSHA regulatory concept applied to only a few substances. The AL is also an exposure limit for airborne concentration (lower than its associated PEL) that, if exceeded, requires certain additional protective measures to be implemented, such as additional confirmatory exposure monitoring, training, or medical surveillance. Although personal exposures in research laboratory environments are generally controlled well below all of these limits by the use of local exhaust devices and room air change rates, laboratories working with any of the chemicals covered by an OSHA substance-specific standard must be aware of the applicable regulatory provisions and implement them.

RELs are additional exposure values that are developed by the National Institute for Occupational Safety and Health (NIOSH). Like TLVs, RELs are not legal standards but are science-based recommendations that do not need to take into account feasibility, financial impact, or other consequences of their use. As a result, RELs and TLVs are generally more conservative (i.e., lower, more protective) than OSHA's limits.

11.A.3. Understanding Other Laboratory Safety Requirements

These rules are vast, complex, and intricate in their details and interrelationships. As noted above, the application and specifics of federal laws vary from state to state, local jurisdictions, and among federal regulatory agency regional offices. Further, there is a great variety of state and local laws, and so requirements depend on the laboratory's location. State and local laws are not covered here, and so specific requirements may vary from the general information provided here. Where available, an EHS officer who is familiar with the details of these rules can act as a resource for scientists. Smaller organizations can seek advice directly from their counsel, insurance provider, regulatory agencies, EHS professionals at other organizations, or consultants.

Table 11.1 lists safety laws that pertain to laboratories, along with their associated regulations. This table is not comprehensive. As noted previously, a detailed explanation of these requirements, and all the non-regulatory safety standards that apply to laboratories, is beyond the scope of this book. Laboratory safety standards that are among the most relevant are those published by the American Industrial Hygiene Association, American National Standards Institute (ANSI; e.g., laboratory decommissioning standard), Clinical and Laboratory Standards Institute (e.g., clinical laboratory waste management), College of American Pathologists, International Association for Assessment and Accreditation of Laboratory Animal Care, and the National Council on Radiation Protection and Measurement (e.g., radiation exposure, waste management). (See Chapter 10, section 10.E, for an explanation of laboratory security requirements.)

Table 11.1. Federal Safety Laws and Regulations That Pertain to Laboratories.

Table 11.1

Federal Safety Laws and Regulations That Pertain to Laboratories.

Two laws that have perhaps the most impact on laboratories are the Occupational Safety and Health Administration's Occupational Exposure to Hazardous Chemicals in Laboratories (the OSHA Laboratory Standard) and RCRA, under which EPA regulates chemical hazardous waste. Because of its importance, the text of the OSHA Laboratory Standard is reprinted in Appendix A. Laboratory workers and managers should read and understand these regulations.

11.B. REGULATION OF LABORATORY DESIGN AND CONSTRUCTION

Laboratory design, construction, and renovation 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 International Building Code (IBC), the International Fire Code (IFC), and the National Fire Protection Association standards.1 For laboratory buildings where hazardous chemicals are stored or used, detailed requirements usually cover spill control, drainage, containment, ventilation, emergency power, special controls for hazardous gases, fire prevention, and building height. Some localities have initiated regulations aimed at increasing efficiency and sustainability in building design. These may become more common in the future, and laboratory designers may wish to consider these issues when planning new construction.

Building and fire codes also apply after construction has been completed. These codes are typically enforced by the fire authority having jurisdiction—usually the local fire marshal. As explained in Chapter 6, sections 6.F.5 and 6.F.7 these codes describe how flammables, reactives, and gases must be stored, and limit their quantities in fire control areas.

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 ANSI and the American Society of Heating, Refrigeration, and Air Conditioning Engineers are relevant to laboratory design. It is not uncommon for various codes and consensus standards to be incorporated into state or federal regulations.

11.C. REGULATION OF CHEMICALS USED IN LABORATORIES

OSHA and EPA regulation of chemical use in laboratories is described below. The laboratory use of controlled substances, regulated by the U.S. Drug Enforcement Agency, is described in Chapter 10, section 10.E.4.1. Select agent toxins are regulated by the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture Animal and Plant Health Inspection Service (APHIS).

11.C.1. OSHA Standards for Specific Chemicals

OSHA has developed comprehensive standards for several chemicals, which are listed in Table 11.2. To prevent exposure to personnel, these standards cover all aspects of the use of these chemicals. These standards are above those required by the Laboratory Standard and, in some cases, may require special signs, medical surveillance, and routine air monitoring of your workplace. For more information, see 29 CFR Part 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.

Table 11.2. Chemicals Covered by Specific OSHA Standards.

Table 11.2

Chemicals Covered by Specific OSHA Standards.

Other OSHA standards setting forth PELs apply to the extent that they require limiting exposures to below the PEL, and, where the PEL or AL is routinely exceeded, the Laboratory Standard's provisions (described below) require exposure monitoring and medical surveillance (see Appendix A, sections (d) and (g)).

If you use these chemicals routinely, even for short periods of time, you should have your workplace evaluated by your EHS officer to ensure that your work practices and engineering controls are sufficient to keep your exposures below the OSHA-specified limits. Because of their common use in campus laboratories, the specific standards for formaldehyde (used as formalin for preservation of tissue samples), benzene, and ethylene oxide are of particular concern.

11.C.2. The OSHA Laboratory Standard

In 1990, OSHA promulgated its Laboratory Standard (Occupational Exposure to Hazardous Chemicals in Laboratories, 29 CFR § 1910.1450; see Appendix A). In brief, the OSHA Laboratory Standard requires organizations to

  1. Keep laboratory personnel exposures to chemicals below OSHA's PELs.
  2. Write a Chemical Hygiene Plan.
  3. Designate a Chemical Hygiene Officer to implement the plan.
  4. Train and inform new laboratory personnel of
    • the OSHA Laboratory Standard,
    • the Chemical Hygiene Plan and its details,
    • OSHA's PELs,
    • the signs and symptoms of exposure to hazardous chemicals,
    • MSDSs,
    • Prudent Practices in the Laboratory,
    • methods to detect the presence of hazardous chemicals,
    • the physical and health hazards of the chemicals, and
    • measures to protect laboratory personnel from chemical hazards.
  5. In certain circumstances, provide laboratory personnel access to medical consultations and examinations.
  6. Keep labels of supplied chemicals intact.
  7. Maintain the MSDSs for all your supplied chemicals.
  8. For chemical substances developed in your laboratory, train laboratory personnel as described above.
  9. Use respirators properly.

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 its general duty clause to apply scientific knowledge in safeguarding workers against risks, even though there may be no specifically applicable OSHA standard. In circumstances where exposure limits are exceeded or where work with particularly hazardous substances is conducted, laboratories must keep records of exposure monitoring and medical surveillance.

The Laboratory Standard refers to the National Research Council's Prudent Practices for Handling Hazardous Chemicals in Laboratories (NRC, 1981) as “non-mandatory … guidance to assist employers in the development of the Chemical Hygiene Plan.”

One of the most common Laboratory Standard OSHA citations has been for failure to have a Chemical Hygiene Plan or for missing an element in the plan. Another commonly cited violation is failure to meet the employee information and training requirements of the Laboratory Standard.

11.C.2.1. The Chemical Hygiene Plan

The centerpiece of the Laboratory Standard is the Chemical Hygiene Plan. This is a written plan developed by employers. It 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;
  • 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.

Section 2.B of Chapter 2 describes additional elements, not required by law, that may be added to a Chemical Hygiene Plan.

Some firms and institutions have developed a single generic Chemical Hygiene Plan for the entire organization. To be most effective, however, the plan should include detailed protections that are specific to each laboratory, project, experiment, procedure, and worker. Laboratory-specific plans allow considerable flexibility in achieving the performance-based goals of the Laboratory Standard. Model Chemical Hygiene Plans are available from your state OSHA consultation service or the American Chemical Society.

11.C.2.2. 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 Report on Carcinogens published by the National Toxicology Program (HHS/CDC/NTP, 1995); (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 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 acute toxicity” are highly toxic noncarcinogenic or highly volatile toxic materials that may be fatal or cause damage to target organs as a result of a single exposure or exposures of short duration. Examples include hydrogen sulfide, nitrogen dioxide, hydrogen cyanide, and methylmercury.

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 organizations 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 little agreement on how to determine reproductive toxins.

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.

11.C.3. Chemical Facility Anti-Terrorism Standards

In 2007, Congress authorized DHS to “establish risk-based performance standards for security chemical facilities.” In response, DHS issued the Chemical Facility Anti-Terrorism Standards (CFATS). According to the agency, the standards identify high-risk facilities based on the likelihood of an attack, the consequences of an attack, and the threat of an attack based on the intent and capability of an adversary. The standards are concerned with

  • EPA Risk Management Plan chemicals,
  • highly toxic gases,
  • chemical weapons convention chemicals, and
  • explosives.

The specific “Chemicals of Interest” are listed in Appendix A of the CFATS rule. (See Chapter 10, section 10.E.4.2 for examples.) The standard applies to any institution that meets or exceeds the threshold quantity established for these chemicals. All facilities, including those with laboratories, are expected to survey their site for the presence of the chemicals of interest and compare the inventory to the threshold screening quantities established in Appendix A of the standard. If the facility meets or exceeds the threshold quantity for any chemical of interest, the facility must report the inventory to DHS.

On the basis of the report, chemical facilities are categorized into risk-based tiers. Each facility is assigned a tier ranging from tier 1 (highest risk) to tier 4 (lowest risk). Facilities that fall into risk tiers 1–3 must prepare a security vulnerability assessment (SVA) to identify facility security vulnerabilities, and develop and implement site security plans. Should a facility fall into tier 4, circumstances may allow for submission of alternate security programs in lieu of an SVA, a site security plan, or both.

For more information about SVAs and CFATS, see Chapter 10, sections 10.F and 10.E.4.2.

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

Regulations pursuant to the Toxic Substances Control Act (TSCA) apply to the use of PCBs and monochlorobiphenyls in laboratories. Although the rules except the use of “small quantities for research and development” and use “as an immersion oil in microscopy,” researchers contemplating work with PCBs (including environmental studies with PCB-contaminated media) should consult their institution's EHS officer because of the stringency of these regulations.

11.D. REGULATION OF BIOHAZARDS AND RADIOACTIVE MATERIALS USED IN LABORATORIES

As explained in Chapter 4, sections 4.H, and Chapter 6, section 6.E.2, most radioactive materials that are used in laboratories are regulated by the U.S. Nuclear Regulatory Commission (USNRC). Rules most pertinent to laboratories are in Title 10 of the Code of Federal Regulations, Parts 20 and 30. The USNRC licenses the use of radioactive materials. Many institutions and firms obtain a broadscope license from the NRC, which provides flexibility but requires an institutional Radiation Safety Officer and Radiation Safety Committee.

As explained in Chapter 4, section 4.G, and Chapter 6, section 6.E.1, the most widely accepted standards for using biohazards in laboratories can be found in Biosafety in Microbiological and Biomedical Laboratories (BMBL; HHS/CDC/NIH, 2007a). The Foreword explains that, “the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories, from a biosafety perspective and is not intended as a regulatory document.” However, many accrediting bodies, grant-making organizations, and state regulators expect laboratories that use biohazards to adhere to the BMBL.

Select agents are regulated by CDC and the Department of Agriculture's APHIS.

11.E. ENVIRONMENTAL REGULATIONS PERTAINING TO LABORATORIES

Federal and state environmental regulations apply to laboratory waste, air emissions, and discharges to the sewer. Of these, EPA's rules for chemical hazardous waste may be the most demanding.

11.E.1. Management of Chemical Hazardous Waste

Chapter 8 covers the regulation of chemical hazardous waste in laboratories, while this section covers the regulation of that waste at an institutional level.

RCRA was enacted by Congress in 1976 to address the problem of improper management of hazardous waste. Subtitle C of that Act established a system for controlling hazardous waste from generation to disposal, often referred to as “cradle to grave.” Under RCRA, EPA is given great responsibilities in promulgating detailed regulations governing the generation, transport, treatment, storage, and disposal of hazardous (chemical) waste. RCRA and EPA regulations apply to laboratories that use chemicals.

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

A generator is any firm or institution whose processes and actions create 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 four 55-gal drums of hazardous waste) or over 1 kg of “acutely hazardous waste” per month. By this measure, most large research organizations, including the larger universities, are large-quantity generators.
  2. Generators of more than 100 but less than 1,000 kg of hazardous waste per month, and less than 1 kg of “acutely hazardous waste” per month (and accumulate less than 1 kg at any one time). This category may not accumulate more than 6,000 kg at any one time.
  3. Conditionally exempt small-quantity generators of 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.

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

Federal and state definitions of on-site have bearing on the generation category of each site, and how laboratory hazardous waste is transported and managed. This is particularly important for firms, colleges, universities, and other organizations that are transected by public roads.

“Individual generation site” is defined by RCRA regulation as a contiguous site at or on which hazardous waste is generated. A firm or institution located in one geographic area may be viewed as a single generator with a single EPA generator identification number or, if it is transected by public roads, may be viewed as multiple generator sites requiring multiple EPA generator identification numbers. Multisite facilities are required to have separate EPA identification numbers for each site.

Note that each individual laboratory generating waste is not itself a RCRA “generator,” but instead is part of the “generator” site. Each laboratory therefore must comply with the requirements applicable to the site's generator category.

RCRA defines “on-site,” 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 definition is that, with one exception, hazardous waste that is being transported on public roads can be sent only to a permitted treatment, storage, and disposal facility (TSDF). The exception [in 40 CFR § 262.20 (f)] explains that this restriction does “not apply to the transport of hazardous wastes on a public or private right-of-way within or along the border of contiguous property under the control of the same person, even if such contiguous property is divided by a public or private right-of-way.”

In all other cases, hazardous waste cannot be transported on public roads to an unpermitted holding facility, even if the public road and the receiving location are within the boundaries of an institution.

11.E.1.3. Minimum Requirements for Generators

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. At most firms and institutions, hazardous waste is shipped off-site, treated, stored, and disposed of at commercial EPA-permitted TSDFs. Note that generators producing more than 1 kg in a calendar month of “acute hazardous waste” (see above) are subject to full regulation under RCRA as a large-quantity generator.

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
  • ensure that the waste is sent to a permitted TSDF or a recycling facility.

Note that state laws may differ. For example, some states regulate all generators of hazardous waste with no exemptions, and some states regulate chemical wastes that are not included in RCRA (e.g., used oil, as hazardous waste).

See Chapter 8, section 8.B.4 for a detailed explanation of hazardous waste collection and storage requirements.

11.E.1.4. RCRA Waste Minimization Requirements

Generators are required to certify on the manifest accompanying off-site shipment of waste that they have a waste minimization program. Guidelines for a waste minimization program are available from EPA. By signing the manifest, the generator is certifying the following:

  • Large-Quantity Generators: “I have a program in place to reduce the volume and toxicity of waste generated to the degree I have determined to be economically practicable and I have selected the practicable method of treatment, storage, or disposal currently available to me which minimizes the present and future threat to human health and the environment.”
  • Small-Quantity Generators: “I have made a good faith effort to minimize my waste generation and select the best waste management method that is available to me and that I can afford.”2

11.E.1.5. Transportation of Chemicals and Hazardous Waste

For organizations 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 organizations, however, have developed policies for on-site transport 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.

As with hazardous materials, off-site transportation of hazardous waste is regulated by DOT in accordance with the Hazardous Materials Transportation Uniform Safety Act. These regulations apply not only to those who actually transport, but also to those who initiate or receive hazardous waste shipments. DOT regulations applicable to transport of laboratory chemicals include those governing packaging, labeling, marking, placarding, and reporting of discharges. Those who prepare hazardous materials for transportation must also meet certain training requirements.

Under the DOT Materials of Trade exception, facilities may transport their own chemicals to another facility owned by the same organization under certain conditions. This exemption also applies to transport for the purpose of chemical demonstrations, such as at a local high school or as part of a special event. All chemicals must be properly packaged in DOT-specification containers. Hazardous waste may not be transported as a Material of Trade.

As explained in Chapter 8, section 8.B.7, EPA's RCRA rules include additional requirements for transportation of hazardous waste. Detail of the many requirements for transporting hazardous waste is beyond the scope of this book.

11.E.2. Management of Radioactive and Biohazardous Waste

Disposal of low-level radioactive waste from laboratories is governed by USNRC rules in Title 10 of the Code of Federal Regulations, Parts 20 and 30, as well as conditions specified in institutional licenses. Short-half-life radwaste is typically held for decay in storage, and then disposed of without regard to its radioactivity.

Federal laws that regulate laboratory biohazardous and infectious waste are limited. Most important are the OSHA bloodborne pathogen standard, DOT rules for transporting biomedical waste, and EPA medical waste incineration rules. The OSHA bloodborne pathogen standard addresses the collection and management of needles, blades, and other sharps. Most states regulate the treatment and disposal of laboratory biohazardous waste; consult your state laws for specific requirements.

11.E.3. Discharges to the Sewer

Contact your local publicly owned treatment works (POTW) for rules on discharges to the sanitary sewer. Your POTW is the best source for information about limits and prohibitions for the discharge of laboratory wastewaters that contain chemicals, biologicals, or radioactive materials. Federal rules exist that pertain to the discharge of hazardous waste and radioactive materials, but those limits are usually incorporated in POTW ordinances.

11.E.4. Air Emissions from Laboratories

The Clean Air Act (CAA) regulates emissions into the air. Laboratories should be aware of the regulations that control stratospheric-ozone-depleting substances. The list of such substances can be found in 40 CFR Part 82, Appendixes A and B to Subpart A. The list includes as “Class I” substances most common freons, carbon tetrachloride, and methyl chloroform.

Under the CAA, EPA also sets national emission standards for hazardous air pollutants (NESHAPs). NESHAPs for radionuclides and sterilants have been established, and these may apply to some laboratories. EPA has not established emission standards for volatile organic compounds or other emissions from laboratory operations, nor has EPA established a special source category for research or laboratory facilities. However, some states have set emission limits that apply to laboratories, or require permits for laboratory hoods. Check with your state environmental agency to determine if there are specific air emission requirements for your laboratory.

11.F. SHIPPING, EXPORT, AND IMPORT OF LABORATORY MATERIALS

Shipping, export, and import laws strictly regulate the domestic and international transport of an extensive list of laboratory materials, including many chemicals, vaccines, genetic elements, microbiological agents, radioactive materials, and a wide array of research equipment, technologies, and supplies. Many items that are not perceived to be particularly hazardous, valuable, or uncommon are nevertheless subject to export control laws and shipping regulations. Export and import laws may require special licenses or permits prior to leaving or entering the United States.

Regulated activities include conveying laboratory materials via

  • shipments and mailings using the U.S. Post Office and other mail couriers;
  • receiving or sending regulated materials by any method of transport;
  • shipments to (exporting) or from (importing) a foreign country;
  • transporting any amount of regulated material in a commercial aircraft, whether on your person or in carry-on luggage or checked luggage.

The many laws for shipping laboratory materials are described below, including regulations from the 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 shipment.

In addition to these requirements, your institution may have entered into a Material Transfer Agreement, which controls any transfer of the research materials from your institution to another.

See Chapter 5, section 5.F for practical, nonlegal information about shipping laboratory materials.

11.F.1. General Shipping Regulations

Regulations on the transportation of hazardous materials are aimed at ensuring that the public and the workers in the transportation chain are protected from exposure to potentially hazardous materials being transported. Protection is achieved through the following requirements:

  • rigorous packaging that will withstand rough handling and contain all liquid material within the package without leakage to the outside,
  • appropriate labeling of the package to alert the workers in the transportation chain to the hazardous contents within,
  • documentation of the hazardous contents within the package and emergency contact information in the event of an emergency with the package, and
  • training of workers in the transportation chain to familiarize them with the hazardous contents so as to be able to respond to emergency situations.

DOT is the national authority that regulates the shipment and transport of hazardous material. DOT regulations governing hazardous materials transport are detailed in Title 49 of the Code of Federal Regulations, Parts 171–178.

Technical Instructions for the Safe Transport of Dangerous Goods by Air, published by the International Civil Aviation Organization (ICAO), are the legally binding international regulations. Annually, the International Air Transport Association (IATA) publishes Dangerous Goods Regulations (DGR) that incorporates the ICAO provisions and may add further restrictions. The ICAO rules apply on all international flights. For national flights (i.e., flights within one country), national civil aviation authorities apply national legislation. This is normally based on the ICAO provisions, but may incorporate variations. State and operator variations are published in the ICAO Technical Instructions and in the IATA DGR.

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

TSCA, administered by EPA, was established to ensure that the human health and environmental effects of chemical substances are identified and properly controlled prior to placing these materials into commerce.

Chemical substances regulated by TSCA include, “Any organic or inorganic substances of a particular molecular identity including any combination of such substances occurring, in whole or in part, as a result of chemical reaction or occurring in nature and any element or uncombined radical.” Chemical substances not regulated or excluded by TSCA include pesticides regulated by the Federal Insecticide, Fungicide, and Rodenticide Act; tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives; radioactive materials regulated by the USNRC; and foods, food additives, drugs, and cosmetics or devices regulated by the Food and Drug Administration.

11.F.2.1. TSCA Research and Development Exemption

TSCA includes a “Research and Development (R&D) Exemption” which greatly reduces requirements for laboratories, but does not eliminate them. Under the R&D Exemption, laboratory chemicals are exempted from many TSCA requirements if they are

  • imported, manufactured, or used in small quantities (“not greater than reasonably necessary for such (R&D) purposes”); and
  • solely for purposes of noncommercial scientific experimentation, analysis, or research, and
  • under the supervision of a technically qualified individual.

To maintain this exemption status, laboratories engaged in R&D must keep records of allegations of adverse reactions and discovery of substantial risk. Also, chemical imports need to be certified in writing, and certain chemical exports require notification of the receiving countries.

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

For R&D laboratories, TSCA is primarily an administrative, records-intensive program. Establish a TSCA compliance file to log significant adverse effects, file reports of substantial risks, and document imports and exports.

Under TSCA § 8(c), laboratories are required to keep 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 skin rash, allergic reaction, or respiratory effect that may be attributable to exposure to an R&D chemical.

Laboratories must also document the discovery of any significant risks to human health or the environment potentially associated with R&D substances. Include this report in your TSCA compliance file.

Your file should also contain TSCA import and export certifications, as described below. 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.

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

Laboratories must complete and send to EPA a TSCA Export Notification Form prior to the exportation of chemical substances listed in the EPA's Chemicals on Reporting Rule (CORR) Database. Sample forms, the CORR Database, and EPA submission instructions are available via the Web (search for “TSCA Export Certification Form,” “EPA CORR Database” and “EPA TSCA Exports”).

Copies of this form must be kept in lab records for 3 years.

An export notification is not required for R&D chemicals not listed in the CORR Database.

11.F.2.4. TSCA Requirements for Other Chemical Shipments

For shipments of R&D chemicals to locations within the United States, TSCA requires that laboratories

  • Label the containers, shipping containers, and shipping papers with “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.”
  • Prepare and include an MSDS for the substance. This MSDS should evaluate and communicate risks of the substance. On the “composition, information on ingredients,” section of the MSDS, indicate, “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.” Alternatively, this information may be included on the shipment form.

If an R&D-exempt chemical is transferred to a pilot plant or manufacturing plant, see EPA rules for the additional requirements.

11.F.2.5. Chemical Imports from R&D Laboratories

Laboratories must complete the TSCA Import Certification Form for all R&D samples and chemicals received from a foreign country. There are no exceptions to this requirement.

Sample forms are available via the Web (search for “TSCA Import Certification Form”), chemical supply vendors, or customs brokers. Unless the imported chemical is excluded (see above), check “Positive Certification” on the Form. Provide this form to the mail or express delivery service or customs broker prior to the import date. Keep a copy in your TSCA compliance file for 3 years.

11.F.2.6. Nanomaterials Under TSCA

In January 2008, EPA issued “TSCA Inventory Status of Nanoscale Substances—General Approach,” which describes the agency's perspective on whether nanomaterials are required to be registered under TSCA. EPA uses “molecular identity” to determine if a chemical substance is new. Substances are said to have different molecular identities if they

  • have different molecular formulas,
  • have the same molecular formulas but different atom connectivities,
  • have the same molecular formulas and atom connectivities but different spatial arrangements of atoms,
  • have the same types of atoms but have different crystal lattices,
  • are different allotropes of the same element, or
  • have different isotopes of the same elements.

Differences in physical characteristics such as particle size and shape are not considered part of a substance's molecular identity. Thus, EPA states, “a nanoscale substance that has the same molecular identity as a substance listed on the TSCA Inventory … is considered an existing chemical, i.e., the nanoscale and non-nanoscale forms are considered the same chemical substances because they have the same molecular identity” (EPA, 2008).

Regulatory controls on nanomaterials will likely change as the field develops, and it is important for researchers and organizations to monitor this area. To assist with future regulatory questions regarding nanomaterials, EPA has created the Nanoscale Materials Stewardship Program. Those who work with nanomaterials should also be aware of international efforts through the International Organization for Standardization and others to develop standards, testing, health and safety practices, etc. and may affect future regulations.

11.F. 3. Requirements for Biological Export and Import

Laboratories that export or import infectious substances, related biological substances, and/or materials that may contain infectious substances should be aware of the following regulatory programs:

  • Infectious Substance (human pathogens) Import Permit Program (U.S. Department of Health and Human Services, U.S. Public Health Service, CDC, 42 CFR Part 71);
  • Animal Pathogens and Related Biological Materials Import Permit Program (USDA APHIS);
  • Importing a Plant Pathogen or Plant Product (USDA/APHIS Plant Protection and Quarantine PPQ, 7 CFR Part 330); and
  • U.S. Fish and Wildlife and CITES Endangered Species Permits (Convention on International Trade in Endangered Species).

11.F. 4. Other Export Regulations

Scientists who ship or carry a research material oversees may be subject to the export licensing requirements of DOC.

DOC's Export Administration Regulations (EAR) require licenses for the export of a wide variety of research materials. These materials (including chemicals and laboratory equipment) are classified and assigned an Export Control Classification Number. (On the Web, search “ECCN List” for examples of regulated exports.)

The type of material, the destination, and the proposed recipient are all subject to approval by the DOC Bureau of Industry and Security, who issues (or may deny) the license. If any of these elements (material, destination, and recipient) are under the control of the EAR, then an export license will be required.

11.G. LABORATORY ACCIDENTS, SPILLS, RELEASES, AND INCIDENTS

Chapter 3 describes laboratory emergency planning and response. This section describes legal requirements for incidents that may occur in a laboratory.

11.G.1. Laboratory Injuries and Illnesses

Immediately report all laboratory injuries and illnesses to your firm or institution's appropriate office (e.g., Workers' Compensation, Risk Management, EHS), even if consultation with a medical professional is not deemed necessary. OSHA requires tracking and reporting of workplace injuries and accidents. State workers' compensation laws detail procedures, provisions, employer responsibilities, and employee rights when dealing with workplace injuries and medical care. Your EHS officer should also be informed of any near misses, spills, releases, accidents, and incidents so that they can be investigated and safety problems are corrected.

OSHA standards and workers' compensation laws apply only to “employees” of laboratory facilities. Unpaid 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.

11.G.2. Planning for Chemical Emergencies

Title III of the Superfund Amendments and Reauthorization Act (SARA Title III) was passed in 1986 to facilitate planning for chemical emergencies. One provision of the law requires that any institution with an EPA-listed “extremely hazardous substance” on-site in greater than its “threshold planning quantities” must notify 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.

SARA Title III also requires facilities that use hazardous chemicals to submit copies of the MSDSs used in their operations and report inventories of hazardous chemicals. Research and clinical laboratories are exempt from these requirements because the law defines “hazardous chemical” 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.” Note that some states require chemical inventories or release notification for laboratories regardless of SARA exemptions.

11.G.3. Notification Requirements for Spills, Releases, and Other Emergencies

SARA Title III also requires that accidental releases be reported to emergency planning authorities. This emergency notification requirement applies to all facilities, including research laboratories, hospitals, and other medical facilities. A firm or institution must 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.”

Also be sure to determine the additional emergency reporting requirements of your state and locale.

11.G.4. Emergency Training and Response

OSHA's standard for hazardous waste operations and emergency response (29 CFR § 1910.120) establishes criteria for training, worker protection, and cleanup of spills and releases to the environment. This standard is an excellent reference for planning your response to laboratory spills and releases. This standard must be followed by spill response contractors and fire departments when they respond to a laboratory emergency involving hazardous materials.

In most cases, however, the immediate, simple cleanup of a spill by laboratory staff is not subject to this requirement. According to 29 CFR § 1910.120(a)(3), “Responses to incidental releases of hazardous substances where the substance can be absorbed, neutralized, or otherwise controlled at the time of release by employees in the immediate release area, or by maintenance personnel are not considered to be emergency responses within the scope of this standard.” That section goes on to say, “Responses to releases of hazardous substances where there is no potential safety or health hazard (i.e., fire, explosion, or chemical exposure) are not considered to be emergency responses.” It is important that facilities have a clear understanding of the circumstances under which employees are expected to respond to incidents, and train employees to be able to identify the difference between a routine incidental release and an emergency requiring outside assistance.

OSHA's bloodborne pathogen standard describes the necessary precautions for cleaning a spill of human blood or body fluids.

Footnotes

1

In 2003, the Building Officials and Code Administrators International, Inc., the International Conference of Building Officials, and the Southern Building Code Congress International, Inc. formed the International Code Council. This body now publishes both the IFC and the IBC among other documents.

2

From 40 CFR § 262.27(a).

Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK55862

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