Collection of Food Safety Data

Gathering food- and feed-safety data is an expensive process. For this reason, developers collect data according to the stage of product development. During the laboratory research stage, if the inserted gene(s) comes from a source known to contain allergens and the GMO under development is intended for the food or feed industry, it is prudent for developers to check the introduced proteins for allergenicity or toxicity. Preliminary food-

safety checks usually involve comparisons of the cloned gene with the DNA and amino acid sequences of known allergens and toxins and, if indicated, the protein may be subject to clinical testing. If the protein is found to be potentially allergenic or to have unacceptable toxic properties, further development of the GMO may voluntarily be halted. Otherwise, good laboratory practice simply requires that experimental GMOs be neither eaten nor allowed to enter any food chain.

As GM lines advance to greenhouse trials, good reason seldom exists to require collection or submission of food- and feed-safety data for approval from the biosafety committee, except when it is difficult to exclude the possibility that the GMO will enter the food chain. Greenhouse studies are used primarily to test for efficacy of the introduced trait and to identify individual lines that will be further tested in field trials. For lines showing promise, however, developers may use greenhouse trials to begin collecting data that later will support a commercial-use application. Greenhouse experimentation can provide the material needed for initial testing of, for example, levels of the foreign protein found in various tissues and at various stages of growth.

Field trials give the first clear indication of how GMOs perform in the environment. At this point, it is usually prudent to make a preliminary assessment of food and feed safety. If data on the GMO's potential toxicity and allergenicity are not complete, regulators typically will require that field trials be conducted at sites not accessible to the general public and that measures be taken to insure against accidental release of GM material into local food chains. Means to control access to the trial site, including access by unauthorized people, animals that may feed on the GMO, and other organisms likely present in the field test area are carefully evaluated by risk-assessment reviewers.

Once individual lines ("events") have been chosen for commercialization, collection of relevant food-safety data begins in earnest. Material from field trials is gathered and used in comparative assessments against the non-GM variety. Food-and feed-safety reviews generally focus on the products of the foreign genes and the characteristics of the whole food. Investigations consider:

• Toxicity to humans, other animals, birds, fish, insects, and soil microbes6

• Pathogenicity

• Allergenicity

• Nutritional and compositional changes

• Digestibility and digestion products

• Stability of gene products and the genes in the food source

• The fate of genes and gene products in food processing

• Any other area that food technologists believe is important to evaluating the safety of the new food for humans and animals

To date, all proteins introduced into transgenic crops currently approved for human consumption have been shown to be nontoxic and nonallergenic.

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