Federal Laws & Regulations
NOTE: Most recent year of amendment may not be listed. Please send corrections to the Office of Research Integrity.
There are three basic categories of Federal requirements associated with the care and use of vertebrate animals: Laws or Acts, Regulations, and Agency Policies or Guidelines.
An Act of Congress or Act is a legislative statute enacted by the Federal Government and is legally empowered by the Constitution. A legislative statute is passed, and therefore becomes federal law, when it receives a simple majority in both houses of Congress and is subsequently signed by the President. The compilation and codification of the laws of the United States of America are called the US Code (USC).
Agencies of the federal government, under rights granted them by the Administrative Procedures Act, create and promulgate Federal Regulations or Administrative Law by a public "rule-making" process. These administrative laws are compiled and codified in the Code of Federal Regulations (CFR). An up-to-date, but not official, electronic version of the CFR called the eCFR is also available. Notices of proposed and final changes to the CFR are posted daily in the Federal Register.
In addition to formal laws and regulations, many Federal agencies issue more informal policies, guidelines, and interpretations that may impact regulated activities. Federal funding agency (e.g. NIH or NSF) guidelines are good examples of this type of controls.
Primary Laws & Regulations
There are two acts that are of particular importance for people working with live vertebrates in research and educational settings; they are the Animal Welfare Act and the Health Research Extension Act of 1985. Combined these acts provide regulatory coverage of all live vertebrates (and some dead ones!) used in research and mandate the creation of Institutional Animal Care and Use Committees (IACUC).
Animal Welfare Act (AWA)
The Animal Welfare Act (US Code, title 7, chapter 54) of 1966 as amended in 1970, 1976, 1985, 1990: Deals with the interstate movement and commercial activities involving various species of animals. The AWA also regulates supply and care of animals destined for research facilities or exhibition. The AWA delegates regulatory oversight to the Animal Care Office within the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture (USDA). For a brief overview of the animal welfare act check out this brochure issued by APHIS.
The AWA defines “animal” as any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any warm blooded animal used for research, teaching, testing, experimentation, or exhibition purposes, or as a pet. By definition, cold blooded species (amphibians and reptiles) are exempt from coverage under the AWA. The AWA further excludes the following:
- Birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research;
- Horses not used for research purposes;
- Farm animals, including livestock and poultry, used or intended for use as food or fiber or in agricultural research;
- Fish; and
- Invertebrates (crustaceans, insects).
The AWA requires all research facilities holding/using AWA covered species to obtain a USDA research registration and submit to periodic inspection by a USDA veterinarian. The USDA Registration number for the UAF animal research facilities is 96-R-0001. The Large Animal Research Station has a separate Exhibitor Registration that covers its public display areas and educational tours.
The AWA associated regulations can be found in 9 CFR Chapter 1. Section 2.31 requires the formation of an IACUC with at least three members including the attending veterinarian and a member not affiliated with the institution.
The Animal Welfare Act regulations also set minimum standards for the transport of live animals ( Title 9, Chapter 1, Part 3: Standards ).
Health Research Extension Act (HREA)
The Health Research Extension Act of 1985 (Public Law 99-158) amended the Public Health Service Act (42 USC 201) and calls for the proper care of animals, the proper treatment of animals (including proper veterinary medical support and nursing care); and the organization and operation of animal care and use committees. The HREA covers the use of ALL live vertebrates and delegates oversight to the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health.
The regulatory guidance for the HREA can be found in Public Health Service Policy on Humane Care and Use of Laboratory Animals.
- PHS Policy section IV.A. requires institutions receiving PHS support to have an Assurance of Compliance with PHS Policy on the Care and Use of Laboratory Animals (PHS Assurance) approved by OLAW. UAF's PHS Assurance Number is A3837-01.
- PHS Policy section IV.A.3.B. requires the formation of an IACUC, but requires a minimum of five members which must include the attending veterinarian, a scientist, a non-scientist, and a member not affiliated with the institution.
In order to maintain our PHS Assurance UAF must adhere to certain requirements including, but not limited to, the following:
- Animal Care Program Evaluations - conducted by the IACUC twice a year, typically in January and July.
- Animal Facility Inspections - conducted by the IACUC twice a year, typically in May and November.
- Reporting instances of serious or continuing non-compliance with PHS policy.
Other Laws and Regulations
Animal Use and Welfare
Combining the AWA and HREA with the other guidelines, regulations, and policies set by various agencies and scientific organizations and you find that ALL vertebrates used at or by UAF are covered by some animal care and use policy or regulation. Some of the other Acts dealing with the use and welfare of live vertebrates are listed below:
Animal Enterprise Protection Act 1992: An Act to protect "Animal Enterprises" (research, testing, and teaching facilities, zoos, circuses, farms, rodeos, fairs) from terrorism. Under this Act: Anyone who causes or plans to cause damage to an Animal Enterprise may be jailed (up to 1 year) and fined; Anyone causing serious bodily injury may be jailed (up to 10 years) and fined. Anyone causing death of an individual may be jailed (for life) and fined.
The Endangered Species Act (US Code, title 16, chapter 35) 1969 (as amended 1973, 1978): Implements the Convention on International Trade in Endangered Species (CITES) in the US. Deals with the regulation of national and international commerce in species listed by the US Department of the Interior as endangered or threatened as well as their protection from hunting, killing, taking and injuring. Also affords protection to endangered species habitat in that areas vital to their survival must not be put at risk by the activities of federal bodies. Permitting and regulatory authority resides with the US Fish & Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS).
The Lacey Act 1901 (as amended 1948, 1949, 1960, 1969, 1981): Prohibits the interstate transport of wildlife which has been killed in violation of state laws. USFWS has enforcement authority.
The Bald Eagle Protection Act 1940 (as amended 1959, 1962, 1972): Protects the national emblem of the USA, the bald eagle, by making it illegal to take or possess such birds or golden eagles (which are not always readily distinguishable), their eggs or nests. Under permit, they may be taken for scientific or educational purposes such as for museums and zoos. Permitting authority is through the USFWS Migratory Bird Office.
The Migratory Bird Treaty Act 1916-1976: These are based on various treaties with other countries and put restrictions on hunting, killing, taking and possession of birds protected by the treaties. Permitting authority is through the USFWS Migratory Bird Office.
The Marine Mammal Protection Act 1972 (as amended 1973, 1976, 1978, 1981, 1984, 1986, 1988, 1990, 1994, 1997): This Act protects species such as dolphins, whales and seals with respect to killing, harassment, hunting and capturing. Requires permits to be obtained to authorize possession and sale of the live animals or their tissues. Some exceptions are allowed for traditional hunting by indigenous populations. Permitting authority is through the USFWS and NMFS.
The Humane Methods of Slaughter Act 1958 (as amended 1978): Requires livestock (cattle, calves, horses, mules, sheep and swine) to be slaughtered by specific methods, including ritual slaughter. In addition, the Federal Meat Inspection Act 1958 (as amended 1979) provides for inspection of handling and slaughter methods for the foregoing species as well as other Equidae and goats to ensure compliance with the Humane Slaughter Act. Regulatory authority resides with the US Department of Agriculture (USDA).
The Horse Protection Act 1970 (as amended 1976) and The Wild Horses and Burros Act 1971 (as amended 1978): Provide protection from various forms of cruelty and the capture and killing of wild horses which live on federally owned public land. Regulatory authority resides with the US Department of Agriculture (USDA).
The Twenty-eight Hour Law 1906: Deals with interstate rail transport of animals destined for slaughter. It requires resting, feeding and watering periods and a restriction on transport for more than 28 hours without such breaks. The importance of this Act has declined with the increase in road transportation. Regulatory authority resides with the US Department of Agriculture (USDA).
The US Fish & Wildlife Service maintains an excellent website (http://www.fws.gov/laws/Lawsdigest.html) that provides links to all of the federal resource laws.
Import/Export Laws and Regulations
Many of the Federal laws and regulations related to wildlife also control the international or interstate transport of regulated species. These regulations are typically know as import/export controls. Information on import/export permitting can be found on the Export Management page of the UAF Office of Research Integrity's website.
Some Pertinent Agencies (there are more!)
- Office of Laboratory Animal Welfare (OLAW), National Institutes of Health, US Department of Health and Human Services
- Animal Care, Animal and Plant Health Inspection Service, US Department of Agriculture
- United States Fish and Wildlife Service (USFWS), US Department of Interior
- National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration, US Department of Commerce
Note: The UAF Office of Research Integrity (ORI) can help you determine the US import/export permit requirements for shipments of protected plants, animals, associated products, or research equipment. Just complete the Export Determination Request Form. The ORI staff cannot know all of the import/export requirements for other countries, but will try and put you in touch with the correct foreign government agency/department.