FOOD SAFETY AND INSPECTION SERVICE (FSIS)

  • FSIS regulates the slaughter of livestock and poultry involved in biotechnology experiments under its regulations for livestock and poultry involved in research. See, e.g., 9 CFR §§ 309.17 and 381.75. Because transgenic research results in only a small proportion of the animals being genetically modified, FSIS regulates the slaughter for food use of those animals with the genetic modification differently than those animals without the genetic modification. FSIS requires approval, under the federal meat and poultry products inspection regulations, before experimental animals may be presented for slaughter. To obtain approval, the sponsor of the transgenic experiments must submit data or a summary evaluation of data to demonstrate that the products of the livestock or poultry will not be adulterated. For nontransgenic livestock or poultry derived from transgenic experiments, the data submitted to FSIS must show that the animals to be slaughtered for food use do not have the experimental transgene, and consequently are equivalent to the parental line and, thus, are not adulterated as a result of the experimentation.

  • If the animal to be slaughtered has the transgenic modification, review and approval in accordance with the regulations are required. FSIS also recommends compliance with its voluntary guidelines set out in its Points to Consider guidance. See Dept. of Agriculture, FSIS, Points to Consider in the Food Safety Evaluation of Transgenic Animals From Transgenic Animal Research (Mar. 1994). Even if the regulations and the Points to Consider document are followed, however, FSIS has noted that the inspector in charge still may deny or withdraw the approval to slaughter if deemed necessary to ensure that products are safe. See generally Dept. of Agriculture, FSIS, Livestock and Poultry Connected With Biotechnology Research, 56 Fed. Reg. 67054 (1991) and Dept. of Agriculture, FSIS, Update on Livestock and Poultry Connected With Biotechnology, Notice, 59 Fed. Reg. 12582 (1994).
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