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Where Is the Government?
The U.S. Department of Agriculture
A perfect illustration: On November 4, 2004, during a particularly disturbing part of the investigation when monkeys were suffering from necrotic open wounds on their stomachs as a result of full-body, lethal irradiation they received at the Armed Forces Radiobiology Research Institute (AFRRI) in Washington, D.C., PETA's director of research & investigations called the U.S. Department of Agriculture (USDA) to say that we had received a report from a Covance worker about monkeys suffering without pain killers or euthanasia. The USDA inspector did not show up at Covance until November 9, 2004! During discussions of the USDA's visit, our investigator was told by her coworkers that the USDA inspector told Covance officials that she takes PETA complaints "with a grain of salt," that everything looked good, and that she would see them next year. In a follow-up call to the USDA, PETA was told that the experiment was a "nasty one" but that records indicated that the USDA inspector found nothing wrong. But PETA's videotape from November 8, the day prior to the USDA's visit, shows a supervisor asking if the irradiated monkeys are receiving painkillers and an employee answering in the negative.
We have filed a 273-page complaint with the USDA about the violations of the federal Animal Welfare Act that we believe occurred during our investigation of Covance.
We have written to Secretary of Agriculture Michael Johanns to ask that he personally handle the complaint.
The U.S. Food and Drug Administration (FDA)
PETA has filed a brief complaint with the FDA, believing that there are issues at Covance relating to the testing of drugs that may violate Good Laboratory Practices (GLP). In the GLPs, animal care is listed as an area of concern for Food and Drug Administration (FDA) inspectors. The FDA regulations describe what is important in the area of animal care:
Animal Care (21 CFR 58.90)
- Purpose: To assess whether animal care and housing is adequate to minimize stress and uncontrolled influences that could alter the response of test system to the test article.
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Inspect the animal room(s) housing the study to observe operations, protocol and SOP adherence, and study records. Refer to IOM 145.2 prior to inspecting sub-human primate facilities.
- Determine that there are adequate SOPs covering environment, housing, feeding, handling, and care of laboratory animals, and that the SOPs and the protocol instructions are being followed.
- Determine whether the facility has an Institutional Animal Care and Use Committee (IACUC). Obtain and submit a copy of the Committee's Standard Operating Procedures and the most recent committee minutes to verify committee operation.
- Determine that all newly received animals are appropriately isolated, identified, and their health status is evaluated.
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Verify that treatment given to animals that become diseased is authorized by the study director and documented.
- For a representative sample of animals, review daily observation logs and verify their accuracy for animals reported as dead or having external gross lesions or masses.
- Verify that cages, racks, and accessory equipment are cleaned and sanitized, and that appropriate bedding is used.
PETA believes that if the FDA uses our investigative information, it may well find violations of its GLPs.
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