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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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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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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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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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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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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
OCR for page 282
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-
