The regulator wants to prevent the possibility allergens or toxins are accidentally introduced into commercial food supplies.
The guidance on genetically modified organisims (GMOs) results from a food or feed safety concern under which a new protein could cause an allergic reaction, or be a toxin in people or animals. The guidance describes the procedure for the early food safety evaluation of new proteins in plant varieties prior to the experimental stage, when the tests are conducted in the field.
The FDA is worried that cross contamination could occur between GMOs and non-GMO crops, possibly forming the new proteins.
"FDA has not found, and does not believe, that new plant varieties under development for food and feed use generally pose any safety or regulatory concerns," the regulator stated this week. "The new guidance is consistent with FDA's policy of encouraging communication early in the development process for a new plant variety."
Rapid developments in research into GMOs are resulting in dramatic changes in the way new plant varieties are developed and commercialized. Scientific advances are expected to accelerate over the next decade, leading to a greater number and diversity of bioengineered crops on the market. However public concerns over the safety of such plant varieties has led to calls for labelling and more testing; Public opposition is particularly high in Europe, where EU members have effectively banned GMO ingredients from the human food chain.
GMO developers would voluntarily provide FDA with information about the food safety of new proteins at a relatively early stage of development of the new crops. Following a decision to commercialize a particular crop, the FDA recommends that each developer participate in its voluntary premarket consultation procedures.
To date, all new biotechnology-developed plant varieties intended to be used for food and feed in the US have completed these consultation procedures before they entered the market.
The issuance of this guidance was proposed in August 2002 by the White House's Office of Science and Technology Policy as part of a series of federal actions also involving the Environmental Protection Agency and the US Department of Agriculture.
The FDA published a draft guidance document for comment on November 24, 2004. The final guidance includes several clarifications suggested in the comments received in response to the draft guidance document.