Other Regulations

On 8 September 2010 the European Parliament adopted a text agreed with the Council to update Directive 86/609/EEC on the protection of animals used for scientific purposes. The aim of the new Directive is to strengthen legislation, and improve the welfare of experimental animals.

AAALAC

AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care) is not an enforcing body; it accredits animal care and use programs. AAALAC accreditation is evidence of compliance with the provisions of the Guide. It was established in 1965 with these objectives:{4099}

1. Humane treatment of laboratory animals

2. Protection of personnel from hazards associated with laboratory animals.

3. Control of variables that could affect animal research adversely.

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The Ag Guide

This publication of the Federation of Animal Science Societies (FASS), the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, was first revised in January 1999{4191} and was revised to the 3rd edition in January 2010. It details institutional policies, which are substantively similar to those presented in the other Guide. It has a chapter on general suggestions for animal husbandry, animal health care, and physical plant. Separate chapters cover specific recommendations for different species of agricultural animals.

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Controlled Substances Act/DEA Regulations

There are five schedules of controlled substances. Schedule I drugs have no accepted medical use, whereas those on Schedule V have the lowest potential for abuse.{3947}

Endangered Species Act/CITES

The Lacey Act of 1900 (16 USC 1361){4099} restricted the import, export, and interstate commerce of several species of foreign wildlife. These species were deemed injurious to public health or agricultural interests or wildlife of the US. If there are proper precautions, the animals may be imported for zoos, education, medical or research purposes. The species named include fruit bats, mongooses, meerkats, European rabbits (Oryctolagus), Indian wild dogs, multimammate rats or mice, pink starlings, dioch, Java rice sparrows, red-whiskered bulbuls, live or dead fish or eggs of salmonids or catfish.{3947}

The Endangered Species Act (16 USC 1531){4099} requires that one have a permit to import or export, take, kill or engage in interstate or foreign commerce with species on the list. It also prohibits possession of unlawfully taken wildlife and sale or offer in interstate or foreign commerce without a warning that no sale may take place until a permit is obtained.{3947} It is enforced by the Department of the Interior{4099}.

The US is also a party to the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) (27 UST 1087, TIAS 8249), an international agreement providing procedures to regulate import, export or re-export of imperiled species.

	Appendix I of CITES are those deemed threatened with extinction and require both import and export permits. Appendix I includes gibbons, all great apes (gorilla, orangutan, chimpanzee), lemurs, and cotton-topped tamarins (Saguinus).
	All other primates are listed in Appendix II, which are less threatened and require only export permits. The US Fish and Wildlife Service provides permits and governs import and export of wildlife.{3947} NHPs may be imported into the US only for educational, scientific or exhibition uses. A minimum 31-day quarantine is mandatory (CL Davis 2001).

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Good Laboratory Practices

The Good Laboratory Practice Act (21 CFR Ch. 1 (4-1-88 edition) covers regulations for animal care in non-clinical laboratories used for products regulated by the FDA. All non-clinical studies requesting research or marketing permits from the FDA must conform to the GLPRs (Good Laboratory Practice Regulations).

1. Animal facilities must have enough rooms to ensure that species, projects, and specially-housed animals are separated. There must be a quarantine area.

2. Isolation is to be provided for biohazards (including volatile substances, aerosols, radioactive materials, and infectious agents) and diseased animals.

3. There are to be separate areas for diagnosis, treatment, food and bedding. The facility design should minimize disturbances of the animals.

4. Personnel must be of sufficient health and wear protective clothing to preclude the introduction of unwanted variables.

5. Equipment must be cleaned and sanitized, and wastes disposed of.

6. SOPs for housing, feeding, handling and care of animals are to be written and followed.

7. Periodic food and water analysis is required to ensure that contaminants do not interfere with a study.

8. Pest control or bedding that might interfere with a study cannot be used.

9. Animals that are kept for an extended period, or in studies that require them to be removed from their cages for any reason must be identified, i.e. by tattoo, toe clip, color code, ear tag or punch.

There is much emphasis on good records. Quality assurance is to be provided for each facility, and it is to be independent from the study director as a watch dog.{3947,4099}

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Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets

Live Animal Regulations (IATA)

USDA and US PHS animal importation regulations

Animals to be imported into the US must be legally exported from the country of origin, have an export permit if required, appear healthy, and enter through one of nine ports of entry. If the animals are potential carriers of human disease, there are other requirements: dogs must have a rabies certificate, NHPs have a 31-day quarantine and can only be used for scientific, educational or exhibition, no more than 6 turtles less than 4" across may be imported for fear of salmonellosis, and psittacine birds must undergo a 30-day quarantine.{3947}

The specific regulations that control importation of NHPs, turtles, dogs and cats is 42 CFR Chapter 1, Part 71. Importation is under the aegis of the CDC.

The USDA controls animal imports that may bring in animal diseases, particularly foot and mouth disease, rinderpest, African horse sickness, and viscerotropic velogenic Newcastle disease.{3947}

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USDA testing of tuberculin (61 FR 51777)

This information can be found at http://www.aphis.usda.gov/animal_health/vet_biologics/publications/604.pdf Guinea pigs are used to test serial dilutions of Koch's tuberculin intradermally.

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Comments? Send an email to janet.rodgers@vet.ox.ac.uk