1. 101. See 61 Fed. Reg. 49,923–26. The Guideline contains detailed specifications for animal facilities used to raise animals for transplant organs. See 61 Fed. Reg. at 49,923–26, §§ 3–3.7. They must meet at minimum the recommendations in the FDA regulations on the care and uses of laboratory animals, the basis of animal lab accreditation. The Guideline prescribes measures to ensure animal health, safety of workers, screening, qualification, and pretransplant quarantine. It provides for the procurement and screening of xenografts, including detailed record keeping, rehearsal of procedures, transportation, and necropsy following animal death. The Guideline reads in quality control terms—it is objective and detached from any sentiment or acknowledgment of the sentience of the pharm's residents, except perhaps in reference to their deaths as “euthanizing.” While most companies comply with requirements for specific-pathogen-free (SPF) environments to raise animals for xenotransplant, some have not. The animals are to be “closed herds,” with new animals introduced only if necessary, after quarantine and careful screening. Reproduction by artificial insemination is recommended to reduce possible transmission of disease vectors. Any animal that becomes sick will necessitate testing of the whole herd. Animal colonies are developed for some species in two types of facilities: SPF facilities and gnotobiotic facilities, in which animals are raised as closely as possible to germ free. The costs of such facilities are tremendous, and the need to raise cesarean-born young in isolation creates ethical issues. Health problems are also associated with motherless young. See J. Randal, “Xenotransplants Moving Ahead Too Quickly for Some,” Journal of the National Cancer Institute, 90 (1998): 348–50. The bibliography contained in the PHS Guideline is a good source for references on raising colonies of primates and swine, and the transmission of zoonoses. See 61 Fed. Reg. at 49,920.
2. 44. See Platt, supra note 28, at A12.
3. 3. See Committee on Xenograft Transplantation Ethical Issues and Public Policy, Institute of Medicine, Xenotransplantation: Science, Ethics and Public Policy (Washington, D.C.: National Academy Press, 1996): at 34 (discussing public education efforts after passage of the National Organ Transplant Act of 1984, 42 U.S.C. § 273) [hereinafter the Institute of Medicine].
4. “An Epidemic of Malassezia Pachydermitis in an Intensive Care Nursery Associated with Colonization of Health Care Workers' Dogs,”;Chang;N. Engl. J. Med.,1998
5. 12. See O'Shaughnessy, H. , “Murder and Mutilation Supply Human Organ Trade,” The Observer, Mar. 27, 1994, at 27 (noting that doctors in Poland and Budapest are selling organs to the Swiss).