WASHINGTON -- The FDA on Tuesday released a ground-breaking policy statement that provides companies with a clearset of guidelines for bringing genetically engineered foodproducts to market.
The key feature of the 76-page document, formally releasedTuesday for public comment, is the FDALs determination thatInew biotechnology techniques do not raise new or uniquesafety issues that warrant additional regulatory oversight.J Aswith all other foods, the regulation of genetically engineeredfood products will depend on their actual ingredients, not onthe process by which they are produced.
The policy constitutes the major portion of a three-part IroadmapJ for commercialization of genetically engineered productsthat was announced in February by President Bush. Twoadditional portions, dealing with environmental concerns andfish and livestock policy, are expected to be released shortly bythe U.S. Department of Agriculture and the EnvironmentalProtection Agency.
At the core of the food document is a IGuidance to IndustryJsection that outlines a decision tree approach to safetyassessment and identifies scientific questions that could raisesufficient concern to warrant consultation with the FDA.
New food products are broken down into two categories. If thefood constituents of a new plant variety are Ithe same orsubstantially similar to substances currently found in otherfoods, such as proteins, fats, oils and carbohydrates, the newproduct will not be subject to pre-market review,J according tothe statement.
However, pre-market safety testing will be required when thecharacteristics of these foods are not Isubstantially similarJ toexisting foods.
Genetically engineered products containing new substances willbe labeled to identify those substances, said Health and HumanServices Secretary Louis Sullivan, but will not be labeledgenetically engineered as such.
How to Determine Need for Regulation
Companies seeking to market a new food product will need toanswer five general questions:
-- Whether the concentration of any naturally occurringtoxicants has been increased.
-- Whether allergens have been introduced.
-- Whether the levels of important nutrients have beenchanged.
-- The safety and nutritional value of newly introducedproteins.
-- The composition and nutritional value of any modifiedcarbohydrates, fats or oils.
Only proteins, carbohydrates, and fats and oils are discussed, inaccordance with the FDA's belief that "these are the principalsubstances that are currently being intentionally modified orintroduced into new plant varieties.JThe decision tree scheme looks at the five main elements of anew plant variety: the characteristics of the host and the donorspecies, the nature of the genetic change, the identity andfunction of newly introduced substances, and any unexpectedeffects of the genetic change.
Flow charts provide detailed questions on each of theseelements. Assessment using the flow charts leads to one ofthree outcomes: Ino concerns,J Iconsult FDA,J or Inotacceptable.J
The Iconsult FDAJ end point means that a producer mustconsult the FDA either on regulatory questions, such aswhether a food additive petition or special labeling is needed,or on technical questions, such as appropriate testing protocolsor specific scientific issues.
The scheme "encompasses everything necessary from ascientific perspective," said Richard Herrett, president ofEnvirag Associates and a director of the Association ofBiotechnology Companies. "It solves the problem of establishingbase lines, of determining chemically what makes a productdifferent."
Opposition Filed by Rifkin
Legal actions to block the new policy were announced Tuesdayby Jeremy Rifkin, president of the Foundation on EconomicTrends. The Foundation said it would file a legal petition withthe FDA demanding that genetically altered foods be labeled assuch and that all new genetic material in food be fullyinvestigated as food additives, Rifkin said.
The Foundation also announced a three-year campaigndesigned to inform the public of potential hazards it sees ingenetically engineered foods. A central focus is to push for FDAregulatory review of Calgene Inc.'s Flavr Savr tomato, widelyexpected to be the first genetically altered food to reach themarket. The Davis, Calif., company (NASDAQ:CGNE) already hassubmitted the tomato for the agency's review.
Calgene shares gained $1.63 to $15.38 on 1.9 million shares.DNA Plant Technology Corp. of Cinnaminson, N.J., which is alsodeveloping genetically engineered tomatoes, as well as oils andother foodstuffs, was up 50 cents to $6.75.
Copies of the proposed policy, "Foods Derived from New PlantVarieties," are available through the FDA Office ofBiotechnology, 5600 Fishers Lane, The Parklawn Bldg., Suite11-34, Rockville, Md. 20857.
-- Kristin Knauth BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.