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Research Animals - Federal Legislation And Oversight

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Facilities that use certain species of live laboratory animals for research purposes must abide by laws and policies governing their use. Although there are a few state laws that also apply, most of the applicable legislation and oversight is provided by federal agencies.

The Animal Welfare Act (AWA)

AWA regulations are enforced by the Animal Care unit of the USDA Animal and Plant Health Inspection Service (APHIS). The regulations govern the housing and care of the animals and include licensing, registration, veterinary, and record-keeping requirements. Covered facilities must register with the USDA.

The AWA does not apply to cold-blooded animals, rats, mice, or birds. These animals do not fall under the definition of "animal" according to the law. This condition was made permanent in May 2002 as part of new federal legislation. The AWA does cover dogs, cats, rabbits, primates, guinea pigs, hamsters, marine mammals, and "other warm-blooded animals."

Under the AWA, each research facility must have an attending veterinarian who is required to provide adequate veterinary care to the facility's animals. The law defines "adequate veterinary care" as "what is currently the accepted professional practice or treatment for that particular circumstance or condition." Each research facility must have an institutional officer who is responsible for legally committing the facility to meet AWA requirements. This officer or the chief executive officer (CEO) of the facility must appoint an institutional animal care and use committee (IACUC) to assess the research facility's animal program, buildings, and procedures. An IACUC must include at least three members—a chairperson, a veterinarian, and a person not affiliated with the institute to represent "general community interests." IACUC members have to be qualified based on their experience and expertise.

An IACUC is responsible for reviewing a research facility's animal use program and inspecting the facilities in which animals are housed and studied. These evaluations must be done at least once every six months. Written reports are required and must be made available to APHIS and to any federal agencies that provide funding to the facility. An IACUC is also responsible for investigating any complaints lodged against the facility regarding the care and use of the animals. This includes complaints from the general public. An IACUC has the power to approve or disapprove proposed animal care and use activities and to ask for modifications in these activities. It can also suspend particular animal activities if it believes they are not being conducted in accordance with its wishes.

Under the AWA any proposed activities must meet certain criteria. Some of the major requirements include:

  • Procedures must "avoid or minimize discomfort, distress, and pain to the animals."
  • Researchers must consider alternative procedures that will not cause more than momentary or slight pain and provide reasons in cases where alternatives cannot be used.
  • Researchers must provide written assurance that the activities "do not unnecessarily duplicate previous experiments."

Any procedures that may cause more than momentary or slight pain or distress require that pain-relieving drugs be administered, unless withholding the drugs is "scientifically justified." Animals cannot be administered paralyzing drugs unless they are also given anesthesia. Those that experience severe or chronic pain or distress that cannot be relieved are required to be painlessly euthanized as soon as possible, unless researchers seek and receive an exemption from the IACUC.

According to APHIS, there were 1,151 registered research facilities in the United States as of July 2004. (See Table 5.3.) California had the most facilities (172), followed by New York (83), Massachusetts (74), Texas (74), and Pennsylvania (66). A list of the research institutions is maintained on the APHIS Web site at http://www.aphis.usda.gov/ac/lists/listr.pdf. The list includes the names and addresses of the facilities. Just over 40% of the facilities are colleges and universities. The remainder are mostly pharmaceutical companies, hospitals, and biotechnology laboratories.

All research facilities are required to comply with AWA regulations. Federal facilities are not required to register with the USDA and are not subject to USDA inspections, though they are required to comply with USDA standards for animal care established under the AWA and must submit annual reports to the USDA regarding their use of regulated laboratory animals. The AWA requires that nonfederal research facilities receive at least one inspection per year to determine compliance with the law. In fiscal year 2002 the Animal Care unit of USDA/APHIS conducted 1,961 compliance inspections, up from 1,556 inspections in 2001.

All registered research facilities must submit annual reports to the USDA listing the number and species of animals used in research, testing, and experimentation and indicating whether pain-relieving drugs were administered. If the drugs were not administered for procedures that caused pain or distress, the report must explain why their use would have interfered with the research or experiment.

In January 2005 the HSUS filed a lawsuit against the USDA for failing to comply with requests under the Freedom of Information Act. The HSUS claimed that since 1999 it requested copies of the annual reports filed TABLE 5.3
Number of USDA-registered research facilities, as of July 2004
SOURCE: Adapted from Facility Lists: Research, U.S. Department of Agriculture, Animal and Plant Health Inspection Service, July 2004, http://www.aphis.usda.gov/ac/lists/listr.pdf (accessed March 17, 2005)

State Number % of total
Alaska 1 0.1%
Alabama 13 1%
Arkansas 9 0.8%
Arizona 10 0.9%
California 172 14.9%
Colorado 27 2.3%
Connecticut 16 1.4%
District of Columbia 5 0.4%
Delaware 6 0.5%
Florida 24 2.1%
Georgia 18 1.6%
Hawaii 2 0.2%
Iowa 19 1.7%
Idaho 3 0.3%
Illinois 40 3.5%
Indiana 22 1.9%
Kansas 12 1.0%
Kentucky 5 0.4%
Louisiana 13 1.1%
Massachusetts 74 6.4%
Maryland 33 2.9%
Maine 7 0.6%
Michigan 28 2.4%
Minnesota 29 2.5%
Missouri 33 2.9%
Mississippi 5 0.4%
Montana 7 0.6%
North Carolina 28 2.4%
North Dakota 3 0.3%
Nebraska 12 1.0%
New Hampshire 3 0.3%
New Jersey 38 3.3%
New Mexico 7 1%
Nevada 2 0.2%
New York 83 7.2%
Ohio 38 3.3%
Oklahoma 17 1.5%
Oregon 10 0.9%
Pennsylvania 66 5.7%
Rhode Island 5 0.4%
South Carolina 11 1.0%
South Dakota 6 0.5%
Tennessee 16 1.4%
Texas 74 6.4%
Utah 10 0.9%
Virginia 18 1.6%
Vermont 4 0.3%
Washington 26 2.3%
Wisconsin 27 2.3%
West Virginia 4 0.3%
Wyoming 2 0.3%
1,151

by research facilities under the AWA. The lawsuit claimed that the USDA had turned over only twenty-four of the approximately 1,400 reports submitted in 1999 and none of those submitted in years 2000–04. The lawsuit also pressed the USDA to provide the public with online access to annual reports and compliance inspection forms. These documents were published on the USDA Web site prior to 2002, but concerns about domestic terrorism prompted the federal government to remove the documents. An HSUS spokesperson criticized the decision, noting that "the USDA appears to be inappropriately shielding animal research facilities from public scrutiny of the treatment of animals in those facilities."

The Health Research Extension Act (HREA)

In 1985 the Health Research Extension Act (HREA) was passed. This legislation requires that facilities conducting animal research, training, and testing activities that receive funding from the Public Health Service (PHS) follow an animal welfare policy called the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHSP). The PHS includes government agencies such as the Centers for Disease Control and Prevention (CDC), the FDA, and the NIH. The NIH is the main public source of funding for biomedical research in the United States.

Affected animal research facilities must follow the recommendations given in the PHS's Guide for the Care and Use of Laboratory Animals regarding housing, cleanliness, husbandry, veterinary care, and use of measures to alleviate pain and distress. The standards are similar to those found in the Animal Welfare Act (AWA), but the HREA applies to all vertebrates, including mice, rats, and birds.

The HREA requires facilities to file annual reports that describe their animal care and use programs and how they comply with the AWA and the PHSP. The PHSP is administered by the NIH Office for Protection from Research Risks (OPRR). Research facilities that receive funding from the NIH must have at least five people on their IACUC. The NIH also reviews planned animal studies to ensure that animal models are appropriate and that no more animals than are necessary are used.

The Food, Drug, and Cosmetic Act (FDCA)

Another major piece of federal legislation that affects laboratory animals is the Food, Drug, and Cosmetic Act (FDCA). The FDCA defines drugs as follows:

  • Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
  • Articles (other than food) intended to affect the structure or any function of the body of man or other animals

Drugs must receive FDA approval before they can be sold in the United States. Although the FDA does not specify the tests that must be done, the agency does not allow human testing to occur if animal safety testing is considered inadequate or incomplete.

Cosmetics are defined as articles other than soap that are applied to the human body for "cleansing, beautifying, promoting attractiveness, or altering the appearance." Soaps are specifically excluded from the regulatory definition of cosmetics, and so do not fall under the FDCA.

The FDA divides cosmetics into thirteen categories:

  • Skin care (creams, lotions, powders, and sprays)
  • Fragrances
  • Eye makeup
  • Manicure products
  • Makeup other than eye (lipstick, foundation, and blush)
  • Hair coloring preparations
  • Shampoos, permanent waves, and other hair products
  • Deodorants
  • Shaving products
  • Baby products (shampoos, lotions, and powders)
  • Bath oils and bubble baths
  • Mouthwashes
  • Tanning products

Cosmetic products and their ingredients (except for color additives) are not subject to premarket FDA approval. However, it is illegal to distribute cosmetics that contain substances that could harm consumers under normal use. Although animal testing is not required by the law, it is recommended by the FDA to ensure product safety. On its Web site in 2005, the agency stated:

FDA continues to work with other governments and private organizations to develop validated alternatives to animal testing in assessing cosmetic safety and considerable progress has been made in some areas. Nevertheless, until a method has been proven to be reliable and accepted by the scientific community, FDA believes that the use of animals remains necessary to ensure the safety of cosmetic ingredients and products.

Cosmetic products that are not adequately tested for safety must have a warning statement on their front label reading "WARNING—The safety of this product has not been determined."

Some consumer products are considered both a drug and a cosmetic under the law—for example, dandruff shampoos, fluoride-containing toothpastes, combination antiperspirants/deodorants, and makeup products or moisturizers that contain sunscreens. These products are subject to provisions of the laws that apply to both drugs and cosmetics.

Other Federal Legislation

The Federal Hazardous Substances Labeling Act was passed in 1960. The Consumer Product Safety Commission (CPSC) administers the law as it applies to household products. This law affects animals because household products (like cleaners) that contain hazardous chemicals must warn consumers about their potential hazards. A hazardous substance is defined as one that is toxic, corrosive, flammable, or combustible; that is extremely irritating or sensitizing; or that generates pressure through heat, decomposition, or other means. Toxicity tests are required to determine these conditions.

Other laws governing chemicals that must be tested for toxicity include the Toxic Substances Control Act and the Federal Insecticide, Fungicide, and Rodenticide Act. Both of these laws are administered by the Environmental Protection Agency (EPA). Animals are commonly used to test the products regulated by all of this legislation.

In 2000 the Chimpanzee Health Improvement, Maintenance, and Protection (CHIMP) Act was passed, calling for the creation of a national sanctuary system for chimpanzees no longer needed in research programs conducted or supported by federal agencies.

In 2002 the NIH awarded a contract to Chimp Haven, Inc., to establish and operate a sanctuary under the CHIMP Act in Shreveport, Louisiana. Construction began in 2003, and the facility was dedicated in 2004. The CHIMP Act is extremely controversial because it allows the animals to be recalled for research purposes if there is a "public health need." Because the act does not call for permanent retirement of chimpanzees, many animal activist groups have called for its repeal.

As of 2005, Chimp Haven estimated that there were more than 1,600 chimpanzees involved in federal research programs. Most were bred or captured from the wild for the performance of AIDS and hepatitis research. Approximately 600 of these chimps are considered surplus laboratory animals and need sanctuary.

In May 2005 the first twenty-two chimps arrived at Chimp Haven, including Rita and Theresa, both of whom were in their early forties and had spent most of their lives as laboratory specimens. The sanctuary was closed to the public while the chimps adjusted to their new home, with the grand opening of the facility scheduled for October 2005 (http://www.chimphaven.org/).

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