Early safety assessment of biotech crops urged

The ability of food crops to produce novel proteins is coming under closer scrutiny, as comments from major interest groups request the FDA to impose mandatory, not voluntary, “early food safety evaluations” of new proteins that might enter the food supply. Biotechnology methods applied to food-producing crops – such as corn, canola and soybeans – give these plants the added capability to produce novel proteins for a variety of uses. Initially, many of the genetically modified plants contained proteins that would reduce the need for pesticides; more recently, plants are being developed to produce pharmaceutical proteins. As the field tests for genetically modified plants increase, the likelihood that cross-pollination due to pollen drift between field test plots and commercial field plots also increases.

Now, the FDA has recently released draft guidance on early food safety evaluation of new bioengineered proteins that might enter the food supply as the result of genetic modifications to the plant. Under this proposal, plant biotechnology developers would provide the agency with information about the safety of the new protein at early stages of crop development. Once a developer decides to commercialize a particular crop, he would be expected to participate in FDA’s voluntary pre-market consultation process. This guidance would only apply to food-producing crops, not to pharmaceutical or industrial crops.

Some major interest groups, such as the Biotechnology Industry Organization (BIO) and the Food Products Association, support a different approach: the use of a mandatory pre-market biotechnology notification (PBN) rule and consultation process, proposed by the FDA four years ago but not yet finalized (Federal Register, January 18, 2001, Volume 66, Number 12). Another group, the Grocery Manufacturers of America, has requested that the agency expand the draft guidance to include plant-made pharmaceutical and industrial crops not intended for food use. In a joint statement, the National Grain and Feed Association (NGFA) and the North American Export Grain Association (NAEGA) have requested that the FDA amend its draft guidance, and advise biotech providers to obtain an early safety assessment of non-pesticidal biotech crops before beginning expanded field trials, particularly in areas where commercial crops of the same plants are grown.