Course Home Chapter One Chapter Two Chapter Three Chapter Four Chapter Five Chapter Six
Some Other Federal Regulations
I. GOOD LABORATORY PRACTICES
Both the U.S. Food and Drug Administration (21 C.F.R. 58) and the U.S. Environmental Protection Agency (40 C.F.R. 160 for Pesticide Program and 40 C.F.R. 792 for Toxic Substances Program) enforce Federal regulations requiring the use of “Good Laboratory Practices” (GLPs). There are additional regulations that apply to laboratory animals when doing GLP research.
The provisions of these regulations contain specific requirements for the care and housing of laboratory animals, as well as for documentation of such care and use, including the development of SOPs, or Standard Operating Procedures, for all aspects of a study, including animal care and use. In addition, a Quality Assurance Unit must be established within an institution to conduct internal inspection of practices and records to ensure compliance with established policies and procedures.
The GLP regulations, as they apply to the use of animals, address such issues as construction and maintenance of facilities, quarantine and isolation, disease diagnosis and treatment, animal identification, caging and routine care, sanitation, and documentation requirements.
These regulations apply to projects that will result in data supporting new drug or medical devices and new pesticide or toxic substances applications, respectively. Researchers conducting studies that may be used as support for human clinical trials should consider following GLP guidelines. In general the recommendations contained in the Guide would suffice in terms of animal care when adherence is properly documented.
II. MARINE MAMMAL CONSERVATION AND PROTECTION ACT
The Marine Mammal Conservation and Protection Act (16 U.S.C. 1361) applies to any program maintaining marine mammals in captivity or interacting with marine mammals in the wild. The Act includes provisions for housing, handling, and care of marine mammals, which are in addition to the marine mammal standards included in the Animal Welfare Act.
III. U.S. FISH AND WILDLIFE SERVICE
The Lacey Act (16 U.S.C. 701) applies to programs involving the interstate transport of wild animals captured in any of the 50 states.
[su_box title=”Key Federal Laws & Regulations Impacting the Use of Animals in Science” box_color=”#b1b564″]
[su_accordion][su_spoiler title=”Animal Welfare Act of 1966″]
ANIMALS PROTECTED: Warm-blooded animals (mammals
and birds), with certain exceptions (below).
EXCEPTIONS: Mice, rats, and birds used in research (see
Animal Welfare Act Amendments of 2002, below); farm
animals used for food or fiber (e.g., sheep’s wool); retail sales
of ordinary pet animals to consumers; animal shelters and
pounds that don’t sell to dealers; ordinary pets.
RESEARCH AFFECTED: Commercial sale, research use, transportation, or zoological exhibition of animals. Implementing regulations of the Animal Welfare Act are found in 9 CFR 1(A)
parts 1, 2 and 3. These regulations are administered by the
U.S. Department of Agriculture and include special provisions
for many species, diseases, and situations, such as scrapie in sheep and swim-with-the-dolphin programs.
ENFORCEMENT: By the Animal and Plant Health Inspection Service of the USDA (APHIS). The Act requires licensing and registration of all affected businesses and research facilities. APHIS performs unannounced inspections at least once a year. APHIS can set civil penalties for infractions, issue cease-and-desist orders, impose fines, and suspend or revoke licenses.
PROVISIONS: Creates general standards, as well as specific standards for individual species such as dogs, cats, horses, marine mammals, and primates. APHIS is not permitted to interfere with research, although research facilities are regulated by the AWA. In effect, this means that pain and distress
imposed by research, within the limits permitted by other
authority, are not actionable violations of the AWA’s standards. The AWA also requires each research facility to establish an Institutional Animal Care and Use Committee (IACUC). Each IACUC is required to submit an annual Animal Welfare
Assurance, including statistics on animal use at that facility.
KEY QUOTE(S): “Although Federal requirements establish
acceptable standards, they are not ideal. Regulated businesses are encouraged to exceed the specified minimum standards.”
— USDA APHIS.
[/su_spoiler][su_spoiler title=”9 CFR 1 A, parts 1 – 3″]
These are the implementing regulations of the AWA.
9 CFR 1 A, parts 1 – 3
Implementing regulations of the AWA.
[/su_spoiler][su_spoiler title=”Health Research Extension Act of 1985″]
The HREA directs the Secretary of Health and Human Services, through the Director of NIH, to create guidelines for the care and treatment of animals used in research. The result was the PHS Policy.
[/su_spoiler][su_spoiler title=”U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training “]
ANIMALS PROTECTED: Vertebrates (animals with backbones; broadest category)
RESEARCH AFFECTED: Testing, research, or training performed or sponsored by any U.S. Government agencies.
ENFORCEMENT: The U.S. Principles are implemented
and supplemented by the PHS Policy.
PROVISIONS: Seeks to minimize the number of animals
used and the pain and distress inflicted, consistent with scientific necessity. Incorporates the Animal Welfare
Act; refers to the Guide for the Care and Use of Laboratory Animals.
KEY QUOTE(S): “Unless the contrary is established, investigators should consider that procedures that cause
pain or distress in human beings may cause pain or
distress in other animals.”[/su_spoiler][su_spoiler title=”Public Health Service Policy On Humane Care And Use Of Laboratory Animals “]
(“PHS Policy”)
(National Institutes of Health, Office of Laboratory Animal Welfare (OLAW). Revised August 2002)
[ Download PDF ]
ANIMALS PROTECTED: Live vertebrates used or
intended for use in research, research training, experimentation, or biological testing or for related
purposes. Note that this includes breeding of animals for later use, as well as birds, mice and rats.
RESEARCH AFFECTED: All research, research training,
or biological testing activities involving animals,
conducted or supported by PHS (including NIH, FDA,
CDC, and others).
ENFORCEMENT: OLAW requires an Assurance of compliance with the Policy before any activities can be undertaken by PHS or with PHS support. In effect, the
Policy requires all grant recipients to comply with the U.S. Principles, the AWA, and the Guide.
PROVISIONS: The Policy endorses the U.S. Principles
and requires compliance with both the AWA and the
Guide, at a minimum.
In addition to the Assurance, the institution must
“establish an Institutional Animal Care and Use
Committee (IACUC), which conducts reviews,
inspections, and reports every six months, using the
Guide. Once a year, the IACUC must make a report to OLAW.
KEY QUOTE(S): “PHS awarding units may not make
an award for an activity involving animals unless the prospective awardee institution and all other
participating institutions have approved Assurances on
file with OLAW, and the awardee institution has provided verification of approval by the IACUC of those
components of the application or proposal related to the care and use of animals.”[/su_spoiler][su_spoiler title=”Guide to the Care and Use of Laboratory Animals “]
(“the Guide”)
[ Web Link ]
Originally published 1963, with support from NIH, as
Guide for Laboratory Animal Facilities and Care; last revision 2011, National Research Council of the National Academies. The Guide endorses the U.S. Principles and, in its post-1985 form, the PHS Policy.
The Guide does not have the force of law or regulation; facilities can deviate from its guidelines for scientific reasons. However, the Guide serves as a standard, compliance with which ensures:
ANIMALS PROTECTED: Vertebrates, including traditional laboratory animals, farm animals, wildlife, and aquatic animals. Note that the Guide does cover birds, mice, and rats, unlike the AWA as modified.
EXCEPTIONS: When appropriate, exceptions or specific emphases for farm animals are provided. The Guide does not specifically address wildlife and aquatic animals studied
in natural settings, invertebrate animals used in
research, or farm animals used in agricultural research or teaching; however, many of the general principles apply. The Guide references The Guide for the Care and Use of Agricultural Animals in Research and Teaching (FASS, 2010) for information in those settings.
RESEARCH AFFECTED: All use of animals in biomedical research, teaching, or testing.
ENFORCEMENT: Via the grant-making process. The
PHS Policy requires institutions to use the Guide as the basis for their programs.
PROVISIONS: Very specific standards in: justification
of the species and number of animals; availability of
less-invasive procedures or alternatives; training and experience of personnel; housing and husbandry requirements; sedation, analgesia, and anesthesia; unnecessary duplication of experiments; multiple major operative procedures; intervention, removal from study,
or euthanasia; post-procedure care; method of
euthanasia or disposition of animal; safety of working environment for personnel.
KEY QUOTE(S): “Institutions should use the recommendations in the Guide as a foundation for the development of a comprehensive animal care and use program and a process for continually improving this program.” Specified outcomes but leaves it up to them how to accomplish these goals.”[/su_spoiler][su_spoiler title=”NIH Revitalization Act of 1993″]
(PL 103-43 § 205)
[ Download PDF ]
Requires creation of a Plan for Use of Animals in Research at NIH. View the current plan here.[/su_spoiler][su_spoiler title=”Federal Food, Drug, and Cosmetic Act as implemented by the Good Laboratory Practice Regulations “]
(GLP)
(21 CFR Part 58)
[ Food, Drug and Cosmetic Act Link ]
RESEARCH AFFECTED: Non-clinical studies (safety
data) in support of applications to the FDA for food or
drug research or marketing permits.
ENFORCEMENT: Compliance is “voluntary”, but the GLP regulations allow FDA inspections[/su_spoiler][su_spoiler title=”ICCVAM Authorization Act of 2000″]
(PL 106-545)
[ Download PDF ]
Empowered the Interagency Committee on the
Validation of Alternative Methods (ICCVAM) to
review federal and federally-funded toxicology testing
for possible reduction of animal use. ICCVAM was
created in the National Institute of Environmental
Health Sciences (NIEHS) at NIH.[/su_spoiler][su_spoiler title=”Memorandum of Understanding Among USDA, FDA, and NIH Concerning Laboratory Animal Welfare 2016″]
[ MOU Link ]
Clarifies the roles of the three agencies:
Primary enforcement of the AWA falls to the Animal and Plant Health Inspection Service (APHIS) of the USDA.
The FDA inspects for voluntary compliance with the Good Laboratory Practice Regulations.
The NIH Office of Laboratory Animal Welfare (OLAW) is responsible for administration of the PHS Policy.[/su_spoiler][su_spoiler title=”Animal Welfare Act Amendments of 2002″]
(PL 107-101)
[ Website here ]
The Farm Security and Rural Investment Act of 2002 (Farm Act) modified the AWA’s definition of animals to exclude rats, mice and birds used in biomedical and behavioral research.[/su_spoiler][su_spoiler title=”Memorandum of Understanding Between VA and NIH Concerning Laboratory Animal Welfare 2002″]
(PL 107-101)
[MOU Link]
Agreement to share information and avoid redundant
effort in monitoring research at or sponsored by the Veterans Administration. Authority to implement the
PHS Policy remains with OLAW.[/su_spoiler][su_spoiler title=”Endangered Species Act of 1973″]
[ Endangered Species Act Link]
In the case of some species, protections administered by
the Department of the Interior may apply.[/su_spoiler]
SOURCE
Adapted from:
Sparks, Joel. “Historical Resources: Timeline of Laws Related to Animal Subjects,” Office of NIH History, Office of Intramural Research, http://https://history.nih.gov/about/timelines_laws_animal.html.
[/su_accordion][/su_box]
The Endangered Species Act (16 U.S.C. 1531) applies to specified species of animals, sometimes from specified geographic areas, which have been determined to be “endangered” or “threatened.” The provisions of the Endangered Species Act may apply to captive bred, as well as wild-caught, individuals of the listed species. Institutions using wild caught or nondomestic animals, including most species of nonhuman primates, should be familiar with the provisions of these Acts and the latest version of the Convention on International Trade in Endangered Species (CITES).
Institutions importing or shipping animals in international trade may also be impacted by CITES (27 U.S.T. 1087, TIAS 8249) if the species involved are covered by the provisions of the ConventionThe U.S. Fish and Wildlife Service, part of the Department of the Interior, is the federal agency charged with enforcing the Lacey Act, the Endangered Species Act and the Convention on International Trade in Endangered Species (CITES).
IV. Guidelines and Regulations for Recombinant DNA,
Biohazardous Agents, Hazardous Chemicals, Radiation Producing Equipment, Radioactive Materials, Controlled Substances, and Select Agents/Toxins
Various Federal and state agencies issue a number of guidelines, and in some cases regulations, which impact upon an institution’s animal care and use program:
Carcinogens, chemicals, and r-DNA National Institutes of Health
Infectious agents Centers for Disease Control
Isotopes Nuclear Regulatory Commission
Radiation and medical waste Food and Drug Administration
Safety and health Occupational Safety and Health Administration
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188; June 12, 2002) requires that the United States improve its ability to prevent, prepare for, and respond to acts of bioterrorism and other public health emergencies. Individuals possessing, using, or transferring agents or toxins deemed a severe threat to public, animal or plant health, or to animal or plant products must notify either the Secretary of the Department of Health and Human Services (HHS) or the Secretary of the Department of Agriculture (USDA). In accordance with the Act, implementing regulations detailing the requirements for possession, use, and transfer for select agents and toxins were published by HHS (42 CFR part 73) and by USDA (9 CFR part 121 and 7 CFR part 331).
A facility that must possess, use, or transfer a select agent or toxin must register with APHIS or CDC, but is not required to submit the application to both APHIS and CDC. Registration also requires that the U.S. Department of Justice (DOJ) complete a security risk assessment (SRA) for the facility, its owners, and the designated responsible official. Before registration is granted, the facility must also meet biosafety requirements that are commensurate with the risk that the select agent or toxin poses and must establish security measures that provide graded protection in accordance with the threat that the agent or toxin poses.
In determining whether a select agent or toxin should be included on the USDA select agents list, the following apply:
- the effect of an agent or toxin on animal or plant health or products;
- the virulence of an agent or degree of toxicity of the toxin and the methods by which the agents or toxins are transferred to animals or plants;
- the availability and effectiveness of medicines and vaccines to treat and prevent any illness caused by an agent or toxin; and
- other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.