Guidance issued for biotech foods

The FDA said that in an effort to address the possibility that material from a new plant variety intended for food use might inadvertently enter the food supply before its sponsor has fully consulted with the government body it was publishing a draft guidance document.

The document is entitled "Guidance for industry: Recommendations for the early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use."

The draft guidance will, according to the FDA, discuss the early food safety evaluation of new proteins in new plant varieties, particularly in new bioengineered varieties that are under development for possible use as food for humans or animals.

It will also explain to the food industry how best to communicate with the FDA regarding this issue.

The FDA explained its decision to publish the guidelines now because: "rapid developments in genomics are resulting in dramatic changes in the way new plant varieties are developed and commercialized."​

The body said that it expects scientific advances to accelerate over the next decade, leading to the development and commercialization of a greater number and diversity of bioengineered crops.

"As the number and diversity of field tests for bioengineered plants increase, the likelihood that cross-pollination due to pollen drift from field tests to commercial fields and commingling of seeds produced during field tests with commercial seeds or grain may also increase,"​ noted the FDA in a statement.

This could result in low-level presence in the food supply of material from new plant varieties that have not been evaluated through FDA's voluntary consultation process for foods derived from new plant varieties.

However, the FDA believes that any potential risks are fairly minimal.

"We believe that any potential risk from the low level presence of such material in the food supply would be limited to the possibility that it would contain or consist of a new protein that might be an allergen or toxin,"​ said the government body.

The FDA has therefore newly proposed that developers provide it with information about the food safety of the new protein at a relatively early stage of the development of a crop. If and when a developer decides to commercialize a particular crop, he would then be expected to participate in the FDA's voluntary premarket consultation process.

Until now, all new plant varieties developed through biotechnology that are intended for food and feed marketed in the United States have completed the consultation process before they entered the market.

The Grocery Manufacturers of America (GMA) welcomed the decision and said it would comment on the guidelines.

"GMA has consistently recommended that the FDA take an early look at the safety of new traits in experimental varieties of biotech foods. To ensure consumer confidence in the safety of the food supply, it is critical that FDA provide its guidance at the beginning of the process,"​ said Mary Sophos, senior vice president of government affairs for GMA.

Food manufacturers may comment on the draft guidance up to 60 days from the date it is published in the Federal Register by writing to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The full text of the guidance can be found online​.