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Four Democratic senators recently introduced “Ensuring Safe and Toxic-Free Food Act of 2023,” which aims to clarify GRAS (generally recognized as safe) status.
December 13, 2023
In the latest congressional action that could impact the food industry, Democratic Sens. Edward Markey, Cory Booker, Richard Blumenthal and Elizabeth Warren introduced S.3387. The “Ensuring Safe and Toxic-Free Food Act of 2023” intends to update and clarify the rule on substances GRAS. At the same time, the bill calls for the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation within FDA.
“Our legislation ensures that the FDA doesn’t fall short on their responsibility to ensure that the food we eat is safe,” Sen. Markey said in a press release. “It is long past time that we revise existing food safety measures and close the loophole by allowing manufacturers to self-regulate what new substances can enter our food supply.”
Sen. Booker described a major gap in U.S. food safety laws that allows food companies to add new chemicals to foods without an independent, scientific review of those additives’ safety.
Center for Science in the Public Interest and Environmental Working Group both support this bill. These organizations have been involved in other food legislation, such as the recent ban of four food additives in California.
GRAS additives are regulated under sections 201 and 409 of the Federal Food, Drug and Cosmetic Act (FDCA). Currently, substances are considered GRAS through scientific procedures or for a substance used in food before 1958 through experience based on its common use in food. FDA last amended the rules on GRAS in 2016.
If enacted, the bill will give control of determination of GRAS status to the Secretary of Health and Human Services Xavier Becerra acting through FDA Commissioner Robert M. Califf, M.D. First and foremost, the manufacturer will have to give the secretary notice that the substance has been determined GRAS under the conditions of its intended use.
Then, manufacturers will also be required to submit numerous pieces of information:
The cumulative effects of the substance, as required under section 409.
An adequately protective use of safety factors to account for the particular sensitivities of vulnerable populations as defined in section 409A(a).
Evidence that shows the substance has not been found to induce cancer when ingested by humans and animals.
Evidence that shows the substance has not been found to induce reproductive or developmental toxicity when ingested by humans or animals, including through an endocrine mode of action.
All the provided information will be made public on FDA’s website for 90 days for the secretary and public to review and object. The secretary will ultimately make the decision, which will be considered the final agency action.
The revision attempts to clarify several points:
Substances that are known or reasonably anticipated to cause cancer in humans or animals will be identified by the National Toxicology Program and cannot be GRAS.
Substances that show clear evidence or some evidence of human reproductive or developmental toxicity will be identified by the National Toxicology Program and cannot be GRAS.
Any substances that were not marketed for use in foods in the U.S. before issuance of the revised rule cannot be GRAS and shall be approved by the secretary through a food additive petition.
Standards will prohibit conflict of interests among experts providing data for substances submitted for GRAS review.
The 2022 FDA guidance, “Best Practices for Convening a GRAS Panel,” will be strengthened.
A process will be created that requires the secretary to systematically reassess any substance that was determined to be GRAS if the initial determination did not meet the revised standards.
The second part of the bill details the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation within FDA to evaluate and reassess the safety of food additives, food contact surfaces, substances with GRAS status and prior-sanctioned substances. Safety reassessments will begin three years after the office is established.
Within 180 days after the bill is enacted, the secretary will establish a Food Chemical Committee within the Science Board to FDA.
In some ways, the proposed legislation echoes the intention of a bill introduced last June by Rep. Jan Schakowsky. H.R.3927, known as the Food Chemical Reassessment Act of 2023, proposed the creation of a new office within the Center of Food Safety and Applied Nutrition and the reassessment of food additives. That bill has not moved past referral to the Subcommittee on Health.
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