FDA Approves Voluntary GM Labeling 29038

FDA Approves Voluntary GM Labeling

WASHINGTON--After months, even years, of waiting for a decision, the Food andDrug Administration (FDA) issued its draft guidance ("Voluntary LabelingIndicating Whether Foods Have or Have Not Been Developed UsingBioengineering") stating that manufacturers can voluntarily label foodsmade with bioengineered ingredients. The proposed rule appeared in the Jan. 18 FederalRegister.

According to FDA, this guidance was in response to food manufacturers wishingto voluntarily label their food and as part of the Clinton administration'sinitiatives to strengthen science-based regulation of and consumer-accessibleinformation 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," whichapplied to foods developed from new plant varieties, including those developedusing recombinant deoxyribonucleic acid (rDNA) technology. However, the 1992policy did not establish special labeling requirements for bioengineered foodsas a class of foods, stating that FDA could not conclude that geneticallymodified (GM) foods significantly differed from other foods.

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

The agency is soliciting comments on the proposed rule, with a specificrequest for comments responding to terms such as "GMO free," "GMfree," "biotech free" and "no genetically engineeredmaterials." As it is, FDA found the term "free" to beambiguous--if it means "zero," it may be hard to substantiate thatthere 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 willenhance consumer confidence in biotechnology," said Rhona Applebaum, vicepresident of scientific and regulatory affairs at the National Food ProcessorsAssociation (NFPA). "However, we believe that education is what is neededto help consumers understand biotechnology and its benefits." According tothe food industry group Grocery Manufacturers of America (GMA), the businesscommunity, government, academia and consumer groups need to collaborativelyeducate consumers to ensure their faith in GM foods.

According to the draft guidance, focus group data indicate that consumerswould prefer biotech labels to state the goal of the technology (i.e. addingvitamin A to 'golden rice' to improve eyesight). It was interesting to note thatconsumers preferred the term "biotechnology" over "geneticmodification" or "genetic engineering." In fact, last summer aHarris Poll found that 86 percent of Americans would want to know if the foodthey were eating was genetically modified.

"Under these rules, American consumers will still be the guinea pigstesting the safety of these foods," said Andrew Kimbrell, executivedirector of the Center for Food Safety and a member of the GeneticallyEngineered Food Alert coalition. "Voluntary labeling means consumers won'tsee 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 foodslabeled 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.