The U.S. Senate recently introduced the “Ensuring Safe and Toxic-Free Foods Act of 2022.” The proposed act would increase regulation of Generally Recognized as Safe (GRAS) substances, including establishment of a new office within the U.S. Food and Drug Administration (FDA) that would assess chemicals in the nation’s food supply.
The bill would revise the GRAS Rule to include provisions that:
- Prohibit manufacturers from independently designating substances as GRAS without supplying proper notice and supporting evidence
- Require that GRAS notice and supporting evidence be made publicly available on the FDA website and be subject to a 90-day public review period
- Prohibit carcinogenic substances and substances that show evidence of reproductive or developmental toxicity from receiving GRAS designation
- Prohibit individuals with conflicts of interest from serving as experts in reviewing and evaluating scientific data with regard to GRAS designations
- Create a procedure of reassessment for substances receiving previous GRAS designations.
The bill also calls for the Secretary of Health and Human Services to create an Office of Food Chemical Safety Reassessment within FDA’s Center for Food Safety and Applied Nutrition. The office would be responsible for assessing the safety of existing food additives, food contact substances, color additives, and GRAS substances. The office would be required to reassess at least ten substances every three years, and identify the conditions of use for substances deemed to be safe.
Finally, the bill would establish a Food Chemical Committee within the Science Board to advise the Secretary of Health and Human Services on standards, processes, and methods for the reassessment of substances. The bill identifies the first ten substances to be reassessed and sets procedures for collecting information relevant to selection and reassessment.