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4. Food Safety Concerns
Pages 61-72

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From page 61...
... genetically engineered animals developed for biomedical or industrial products. This latter category is considered because entry of these animals into the food chain might be proposed at the end of their productive life or sooner, as in the case of unused females and males, which typically are not used to generate the recombinant product (e.g., bulls in which the recombinant protein is expressed in the mammary gland)
From page 62...
... Secondary concerns for food safety arise from the disposition of carcass remains after removal of the edible meat, and from the disposal of animal fecal material. (Potential environmental concerns related to fecal material from genetically engineered animals are discussed in Chapter 5.)
From page 63...
... ;^ FOOD PRODUCTS FROM NON-GENETICALLY ENGINEERED CLONED ANIMALS The cloning technologies of embryo splitting (EMS; Willadsen, 1979; Williams et al., 1984) and blastomere nuclear transfer (BNT; Willadsen, 1986; Prather et al., 1987)
From page 64...
... Nevertheless, it would seem appropriate that the FDA use available analytic tests to evaluate the composition of food products from animals that themselves result directly from BNT cloning procedures to verify that they fulfill existing standards for animal-derived food products. The products from the offspring of cloned animals were regarded as posing no food safety concern because the animals are the result of natural matings.
From page 65...
... However, the committee found it difficult to characterize the level of concern without further supporting evidence regarding food product composition. Currently, there is no evidence that food products derived from adult somatic cell clones or their progeny pose a hazard (i.e., there is no evidence that they present a food safety concern)
From page 66...
... gene has been used to direct expression of a transgene in mammary tissue, and some concentration of WAP normally is found in the blood of lactating animals (Grabowski et al., 1991~. Hence, through bioactivity, allergenicity, or toxicity pathways, ectopic gene expression might directly affect the safety of food products derived from tissues, sexes, or life stages of transgenic animals where transgene expression is not expected.
From page 67...
... Should pharmaceuticals or other biologically active proteins enter the food supply through products of such animals, associated food safety concern could be high. Additionally, the effects of transgene expression on animal wellbeing might indirectly affect the safety of food products derived from their tissues through stress-mediated mechanisms.
From page 68...
... A more difficult issue arises when a new protein comes from a source that historically is not a human food. Assessing the potential allergenicity of transferred proteins remains one of the most difficult aspects in the overall safety assessment of transgenic foods.
From page 69...
... The possibility that particular novel gene products might trigger allergenicity or hypersensitivity responses will vary with the gene product at issue, and poses a moderate level of food safety concern (i.e., the likelihood of a reaction is of moderate concern, but when it occurs, it could be a severe)
From page 70...
... aureus or Vibrio anguillarum. Thus, food products containing antimicrobial proteins might present a food safety concern in view of their potential to alter the balance of consumers' intestinal flora, and might foster the evolution of microbial strains resistant to specific agents.
From page 71...
... Against the background of the discussion above, the committee regards the likelihood that a bioactive product poses a hazard will vary among gene products, food products, and consumers, in various cases posing a low to moderate level of food safety concern. For a susceptible individual, however, such a hazard could have severe consequences.
From page 72...
... i 72 ANIMAL BIOTECHNOLOGY: SCIENCE-BASED CONCERNS not examine during its deliberations) and are applied, the possibility of such toxicity poses a low level of food safety concern to the committee.


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