Natural Foods Merchandiser

FDA sets sights on food safety, biotech

The U.S. Food and Drug Administration has an ambitious roster of goals for 2005, and some of them could dramatically change the product assortment retailers may carry. The FDA?s Center for Food Safety and Applied Nutrition based its priorities on comments received both internally and from stakeholders, and released them in a news conference in December 2004. ?We tried to get the biggest bang for the buck,? says Robert Brackett, director of CFSAN, while acknowledging that food safety and food defense would be central themes for the year.

If your customers are fans of sprouts or raw dairy products, or are wary of biotechnology, you?ll want to pay close attention this year to FDA?s moves. Among the agency?s A-list goals is a re-examination of the safety of raw dairy products. ?There?s an interest in people consuming more unpasteurized raw milk products,? Brackett says. ?We need to see what?s actually going on.? Specifically, the agency intends to step up inspection of manufacturers of raw dairy products, ?with an emphasis on raw milks, creams, butters and margarines, soft unripened cheeses and fresh soft cheeses,? according to ?FY 2005 CFSAN Program Priorities.?

Last year the agency conducted about 7,000 domestic inspections for what it considered high-risk foods, and plans to continue ?focusing on those companies and circumstances that will have the biggest public health impact,? Brackett says. CFSAN also plans to complete an evaluation of the science of raw milk cheese and crack down on the illegal importation of certain cheeses. If resources allow, CFSAN would also seek to validate new technologies for pasteurization that the industry might develop. ?We want to make sure that products that are labeled as pasteurized do not include raw milk,? Brackett says.

Produce, too, could be subject to new oversight. In particular, the safety of sprouts is of concern to the agency. Since 1995, raw sprouts have been blamed for outbreaks of Salmonella and E. coli, perhaps due to contamination at the seed level. ?The number of illnesses associated with fresh sprouts is unacceptable,? says Brackett. But because of their high antioxidant, folate and fiber content, sprouts have long been popular with health-conscious consumers. They?re also favored among slow-food advocates since they can be grown in most climates year-round.

CFSAN intends to hold a public meeting this year on sprout safety and initiate rulemaking for sprouts. ?The public meeting is designed to ? get more input,? Brackett says. The agency is open to all possible approaches to improving sprout safety, whether those involve irradiation, seed decontamination or some other method, a spokesman says.

CFSAN also plans to issue a white paper on good manufacturing practices for food—possibly this spring—as well as broad draft guidance for fresh-cut produce—and also plans to carry out a consumer education program concerning the safe handling of produce. ?We have produce items that are increasingly becoming associated with [foodborne illness] at a time when we are trying to increase consumption of fresh fruits and vegetables,? Brackett says.

Brave new world of food
Some of CFSAN?s other goals focus on identifying chemical contaminants such as furan and perchlorate (for more information on these chemicals, see ?When bad things happen to good food?) in food and assessing their risk and the effects of varying cooking methods on their concentrations. ?The one thing we?re trying to do is get a good scientific handle, first of all, on what the scope of the contamination is, and is it a significant public health threat or is it at such a low level that it?s not,? says Brackett.

Labeling promises to be another area of concentration this year for the agency. Among its A-list objectives: obtain expert consultation on gluten-free labeling; publish a proposed rule for carbohydrate labeling; develop a strategy to address claims and disclosures on trans fats; and publish a proposed rule to revise the existing regulation that requires irradiated food to be labeled.

The CFSAN spokesman declined to suggest that FDA would consider allowing irradiated food to be sold without labeling. ?Perhaps it would be better to say that the labels could be different than currently prescribed by regulation. FDA has been directed by Congress to do so,? he says, citing a May 2002 provision from the Farm Security and Investment Act. ?The recently amended statute also allows companies to come up with their own non-misleading labeling,? he says.

If such a rule is adopted, it is sure to raise the ire of the natural products industry. ?We want more labeling, not less,? says Craig Winters, executive director of The Campaign, a nonprofit group that advocates for labeling of genetically modified foods. ?[We] will oppose the attempt to eliminate the radura and front-of-the-package labeling.?

Other technology will also come into FDA?s crosshairs this year. CFSAN plans to ?issue final guidance concerning the early food safety evaluation of new plant proteins produced by bioengineered plants intended for food use that may be present in the food supply, but that have themselves not completed all regulatory steps for marketing.?

According to draft guidance issued in November 2004, ?Developers would provide FDA with information about the food safety of the new protein at a relatively early stage of development of the crop.? The document goes on to say, ?To date, 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.?

If resources allow, CFSAN also hopes to develop final guidance on the use of antibiotic-resistant genes in bioengineered plant foods.

?Based on past guidelines, we are not optimistic,? says Winters. ?Unfortunately, the guidelines will most likely reflect industries? best interests over the public?s best interest.?

Winters notes that FDA has a history of approving genetically modified foods without proper testing. When the Flavr Savr tomato was introduced in 1994, non-governmental organizations insisted that antibiotic-resistant genes should be regulated under the Food Additive Law. But despite internal FDA documents that reportedly noted that ?the Flavr Savr could not meet the criteria of reasonable certainty of no harm,? it was still green-lighted, as have 53 additional GMO products since that time, he says.

?In general,? Winters says, ?we are concerned that antibiotic-resistant genes in bioengineering could cause a problem by developing antibiotic resistance in humans. We also believe that these products should undergo thorough testing before being fed to humans.?

Natural Foods Merchandiser volume XXVI/number 3/p. 60, 62

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