The U.S. Food and Drug Administration’s proposed new biotech food-review requirements and guidelines are drawing sharply mixed reviews from consumer/environmental activist, food industry and biotechnology groups.
The proposal would make it mandatory for food developers to notify the FDA at least 120 days in advance of their intent to market a food or animal feed developed through biotechnology and to provide information to demonstrate that the product is as safe as its conventional counterpart.
But while giving some tips on what is and isn’t acceptable for labels on biotech-linked products, the FDA left its new labeling guidelines as voluntary measures for manufacturers and marketers.
The proposed mandatory review “consultation” process compares with current rules that allow biotech developers of food and feed to participate in a voluntary consultation program with FDA.
In a separate but related action, the FDA is issuing a draft guidance document, which if approved, would provide direction to manufacturers who wish to label their food products as being made with or without ingredients developed through biotechnology.
The Biotechnology Industry Organization (BIO) and the National Food Processors Association (NFPA) praised the FDA’s proposals.
Grocery Manufacturers of America (GMA) agreed. “This is a victory for consumers,” said dietitian Lisa Katic, GMA’s science and nutrition policy director. “This will make an already effective regulatory system more open and transparent. Most importantly, there is again renewed acknowledgement that food biotechnology is safe.”
But the proposals got a thumbs-down review from Consumer Federation of America (CFA), which has condemned current FDA procedures as “too little government oversight” that “allows manufacturers complete freedom to assert a new product is ‘substantially equivalent’ to an existing food.”
The FDA proposal offers “little meaningful change,” the CFA said in a publicity release.
“It continues the regulatory charade detailed in a (CFA) report issued just last week,” CFA said, citing three major flaws in current and proposed regulatory procedures:
The FDA review process will continue not determining whether a new genetically or existing genetically modified food is safe, the consumer group said.
“Second, while the manufacturer’s application and supporting data will be available immediately, there will be no public hearings or other opportunities to formally question the data or challenge the company’s assertion that its product is safe” prior to it going on the market and into foods sold in stores or restaurants, CFA said.
“Third, the labeling requirement is voluntary,” CFA said. “If a company wants to tell the public its product has genetically modified corn or soybeans, it may do so. If a company wants to hide a material fact, the presence of genetically modified protein, it can do so.”
The FDA said: “The draft guidance on labeling will assist manufacturers who wish to voluntarily label their foods as being made with or without the use of bioengineered ingredients. This guidance will aid manufacturers in ensuring that their labeling is truthful and not misleading.”
The FDA said it views labels with the terms “derived through biotechnology” and “bioengineered” as acceptable.
But not acceptable, the FDA said, are such terms as “GM free” or “GMO,” or “modified.”
The FDA said it will use its web site’s reading room to post information submitted by manufacturers in the consultation process and the FDA’s own responses on the new food products and the foodmakers’ methods and plans.
Carl Feldbaum, BIO’s president, labeled the FDA proposal as “another milestone towards maintaining consumer confidence in and support for biotechnology as an essential tool in modern food production.”
Representing 940 biotech companies, universities, state biotech centers and related organizations, Feldbaum said in a publicity release: “The increased openness and accountability that will flow from the changes FDA announced today provide renewed grounds for the confidence American consumers have in our food supply and the regulatory system to ensure its safety. The U.S. regulatory system is a model around the world because it is grounded in science, not superstition, or uninformed emotion.”
The NFPA, talking for the nation’s $460-billion food processing industry, called the FDA move “the right decision.”
The proposal “is a strong step forward for consumer confidence in food biotechnology,” the industry group said in a publicity release.
“Making the pre-market review process mandatory is the right decision,” said Rhona Applebaum, NFPA’s executive vice president of scientific and regulatory affairs. “It reflects the recommendations we’ve repeatedly made to FDA.”
She added: “FDA’s announcement indicates thatthis revised review process will be thorough, rigorous and scientifically based, which we believe will lead to increased consumer confidence in this important technology.”
Applebaum said the NFPA agrees with the FDA labeling proposal. “We believe it is essential that mandatory labeling be reserved for information that is material – that is, information that goes to the safety, health, composition or nutritional value of the food,” she said.
Instead of mandatory labeling, she said, the NFPA wants education “to help consumers understand biotechnology and its benefits. The information needed by consumers to better understand this important technology cannot be conveyed by a warning-type label.”
The FDA claims that “to date, all such food and feed marketed in the U.S. have gone through the consultation program before they have entered the market.” The FDA also says the voluntary consultation process has worked well since its inception in 1994.
But, the agency said, public meetings and written comments showed “considerable public support for a mandatory and more transparent process.”