Comment from National Alliance for Hispanic Health

The National Alliance for Hispanic Health (the Alliance), representing community-based organizations and providers serving 15 million persons each year, strongly supports proposed rules to amend the food additive regulations and color additive regulations to remove the solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene. Further, FDA should take action to remove these carcinogenic solvents from food-related approvals in the shortest feasible timeframe to protect the public’s health. People have falsely believed that foods, beverages, and color additives allowed by FDA do not rely on chemicals that federal and international authorities have identified as cancer hazards. Now is the moment to make this a reality. It is especially important for individuals and families who are already working to reduce health risks, including pregnant women, children, older adults, people living with chronic disease, and communities that face cumulative environmental and health burdens. The law and the public health principle are clear: carcinogenic chemicals should not remain approved for use in food, particularly when safer alternatives are available. The Alliance recognizes that industry representatives have argued that exposure from certain uses, particularly methylene chloride in decaffeinated coffee, may be low. However, many consumers select decaffeinated coffee because of pregnancy, cardiovascular disease, anxiety disorders, medication interactions, sleep concerns, or other health conditions. Individuals making those choices should have confidence that the manufacturing process itself does not rely upon avoidable carcinogenic solvents when safer alternatives are available. The question at hand is not whether exposure can be characterized as small in a particular product or under a particular calculation. The question before the FDA is whether it should continue to approve the use of carcinogenic solvents in food and color additive regulations when those uses are unnecessary, avoidable, and replaceable. Industry has demonstrated the ability to produce many affected products using alternative technologies. Maintaining outdated regulatory permissions for chemicals that are no longer necessary for product production clearly provides no public benefit and creates avoidable uncertainty about the safety of the food supply. As the FDA enacts the proposed rules, the Alliance encourages FDA to pay particular consideration to the following implementation issues. •Develop an information strategy to inform consumers of the change. Consumers should not have to determine independently whether products were manufactured using carcinogenic solvents. Given that there is likely to be a staged implementation, it will be important to help consumers understand the change in food and color additives, the timelines for eliminating from what products, and how to tell if the products they purchase are free of the solvents represented under these dockets. Clear, consistent communication from FDA will promote confidence in the safety of the food supply and reduce misinformation during the transition. •Publish a timeline for implementation that fast tracks compliance. The proposal to remove the solvents under these dockets as food and color additives was first published in the Federal Register January 11, 2024 giving industry ample time for the change. A timeline should be established for removal of the solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene that achieves the removal in the shortest feasible timeframe and certainly no later than the end of 2027 when the six remaining certified color additives frequently used in the food supply are also slated to be eliminated. •Publish implementation guidance concurrently with final action on FDA-2023-F-5684 and FDA-2023-C-5679. FDA should issue technical guidance describing compliance expectations, recommended documentation, recordkeeping, acceptable transition practices, and other implementation considerations. Early guidance will reduce uncertainty and encourage consistent compliance throughout the regulated industry. The FDA should also maintain ongoing communication with public health and consumer groups on milestones in implementation of the technical guidance. Importantly, implementation guidance should make sure clear that established transition timelines are finite. The proposed actions under FDA-2023-F-5684 and FDA-2023-C-5679 represent important steps to ensure that FDA regulations reflect current science, modern manufacturing capabilities, and sound public health policy. Removing outdated approvals for carcinogenic solvents will reduce avoidable health risks, encourage continued innovation in food manufacturing, strengthen consumer confidence, and reinforce FDA’s commitment to protecting the health of the American public.