Tomorrow’s planned publication of a new federal rule on substances in food that are “generally recognized as safe” — GRAS — has already drawn fire that includes possible congressional action. The Food and Drug Administration’s final rule on GRAS substances in human and animal food is scheduled to take effect 60 days after it is published in the Federal Register. grasFDA_406x250GRAS substances are not subject to FDA pre-market approval, but they must meet the same safety standards as approved additives. “Although we have pre-market review authority over food additives, a food manufacturer can intentionally add a substance to human food or animal food without our pre-market review or approval if the substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use…” says the FDA final rule. Although GRAS is seen by some as an in-the-weeds detail of FDA’s responsibilities, the publication of the final rule has generated opposition from some of the so-called food police groups. The final rule allows experts chosen by food manufacturers to determine whether a substance can be considered GRAS, making such situations ripe for conflicts of interest, the critics say. “Decisions about the safety of substances in our food supply should be transparent and unbiased,” said Jessica Almy, deputy director of nutrition policy at the Center for Science in the Public Interest (CSPI). “However, today’s rule gives companies a green light to make decisions about which substances are GRAS and can be added to food without even informing the FDA. The new rules also fails to ensure that the experts make these decisions do not have conflicts of interest.” Almy argues that FDA should not allow companies to make “secret, potentially biased determinations” about which substances are GRAS. The CSPI publishes the “Nutrition Action Healthletter” and on issues involving nutrition, food safety and health. Tom Neltner, chemical policy director for the Environmental Defense Fund, said the final GRAS rule is a “lost opportunity to close a widely-abused loophole that allows chemicals to be approved for use in food with no notification or review by FDA.” He said FDA “has the legal authority to significantly narrow the GRAS loophole to prevent companies from deliberately avoiding FDA’s safety review process.” Sen. Ed Markey, D-MA, called the final GRAS rule “a missed opportunity.” He called it “a self-graded take home exam that the industry does not even have to hand in.” He called for “mandatory reporting of GRAS substances.” He promises to “explore whether a legislative remedy is needed to ensure the safety of our food supply.” FDA was given authority to regulate additives in food by Congress in 1958. GRAS has existed in its current form under a preliminary rule since 1997. Going to a final rule helped FDA reach a settlement agreement with the Center for Food Safety in 2014. The Pew Charitable Trusts, from 2010 to 2013, conducted a comprehensive assessment of the federal food additives regulatory program. Its conclusion: “With more than 10,000 additives allowed in food, Pew’s research found that the FDA regulatory system is plagued with systemic problems, which prevent the agency from ensuring that their use is safe.” The final report of the Pew food additive project was issued in 2013. According to an FDA constituent update, the GRAS final rule is “the most recent step we are taking to strengthen the FDA’s oversight of substances added to human and animal food.” FDA says the next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods and Veterinary Medicine Program’s Strategic Plan, the FDA will develop and implement regulatory and compliance strategies to improve pre-market oversight and safety evaluation of human and animal food additives and GRAS substances. One more thing FDA says about the final rule. The agency “strongly encourages” companies to inform the agency of GRAS conclusions through a voluntary notification procedure finalized in the rule. “While the FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts,” according to the FDA constituent update. GRAS requires the use of safe ingredients in human and animal food that are “widely recognized” by qualified experts. (To sign up for a free subscription to Food Safety News, click here.)