FDA Approves Voluntary GM Labeling

WASHINGTON--After months, even years, of waiting for a decision, the Food and Drug Administration (FDA) issued its draft guidance ("Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering") stating that manufacturers can voluntarily label foods made with bioengineered ingredients. The proposed rule will appear in the Jan. 18 Federal Register.

According to FDA, this guidance is in response to food manufacturers wishing to voluntarily label their food and as part of the Clinton administration's initiatives to strengthen science-based regulation of and consumer-accessible information to bioengineered foods.

This new guidance fills in the holes FDA left in its 1992 policy, "Statement of Policy: Foods Derived from New Plant Varieties," which applied to foods developed from new plant varieties, including those developed using recombinant deoxyribonucleic acid (rDNA) technology. However, the 1992 policy did not establish special labeling requirements for bioengineered foods as a class of foods, stating that FDA could not conclude that genetically modified (GM) foods significantly differed from other foods.

In 1993, FDA requested industry comments in regards to biotech labeling, and received more than 50,000 written comments. Many comments expressed concerns about the "unknown," such as the long-term health consequences from consuming GM foods. In the 2001 guidance, FDA reported that it was still unaware of any conclusive health concerns for GM foods or ingredients. "We are, therefore, reaffirming our decision to not require special labeling of all bioengineered foods," FDA wrote.

Currently, the agency is soliciting comments on the proposed rule, with a specific request for comments responding to terms such as "GMO free," "GM free," "biotech free" and "no genetically engineered materials." As it is, FDA finds the term "free" to be ambiguous--if it means "zero," it may be hard to substantiate that there are absolutely no GMOs in a food product. Also, does "GM free" imply that a product is healthier or more superior to biotech food?

"Some consumer groups have argued that only mandatory labeling will enhance consumer confidence in biotechnology," said Rhona Applebaum, vice president of scientific and regulatory affairs at the National Food Processors Association (NFPA). "However, we believe that education is what is needed to help consumers understand biotechnology and its benefits." According to the food industry group, Grocery Manufacturers of America (GMA), the business community, government, academia and consumer groups need to collaboratively educate consumers to ensure their faith in GM foods.

According to the draft guidance, focus group data indicate that consumers would prefer biotech labels to state the goal of the technology (i.e. adding vitamin A to `golden rice' to improve eyesight). The report stated that consumers preferred the term "biotechnology" over "genetic modification" or "genetic engineering." In fact, last summer a Harris Poll found that 86 percent of Americans would want to know if the food they were eating was genetically modified.

"Under these rules, American consumers will still be the guinea pigs testing the safety of these foods," said Andrew Kimbrell, executive director of the Center for Food Safety and a member of the Genetically Engineered Food Alert coalition. "Voluntary labeling means consumers won't see any labels out of this, and [they] won't have a right to choose." However, under the National Organic Rule, issued in late December, all foods labeled as "certified organic" must be free of GM ingredients.

Comments will be taken through March 19 at the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20853. For a copy of the guidance, visit www.fda.gov/OHRMS/DOCKETS/98fr/cf0074.pdf.