FDA’s new post-market food chemical safety program a step forward, but gaps leave Americans at risk

• FDA action: The FDA finalized a new post-market food chemical safety program that could improve oversight of chemicals already in the food supply.
• Missing pieces: The program still lacks some key details, including clear timelines for prioritizing, assessing and mitigating chemical risks and an adequate review process for understudied chemicals.
• Health risks persist: By failing to address risks from cancer-causing substances, cumulative health effects and more, the program leaves Americans at risk.

“All Americans deserve to know their food is safe. This new program is an important step forward, incorporating changes that we at Environmental Defense Fund have been urging for years,” said Maria Doa, Senior Director, Chemicals Policy. “At the same time, the program leaves several questions unanswered that are critical to delivering safer food. It fails to fully ban carcinogens and address cumulative effects, leaving pathways open for harmful chemicals to still end up in Americans’ food.”

Real improvements made, but too many risks remain

The FDA recently finalized its food chemical safety post-market assessment program, a step forward toward reducing health harms from chemicals in food that Americans have been exposed to for years, if not decades. However, the program leaves vital questions unanswered and fails to adequately address cancer-causing chemicals and other major risks.

The new program includes important features recommended by Environmental Defense Fund and partners to streamline and enhance the prioritization and review process, strengthen the toxicity criteria for prioritizing chemicals of high concern, increase stakeholder engagement and incorporate peer review of its scientific assessments.  

Key gaps in FDA’s new post-market chemical safety assessment program

• The FDA has not set out clear timelines for chemical prioritization and assessment as well as for when to incorporate peer review into the post-market assessment process.
• The FDA will continue treating already approved cancer-causing food additives as safe unless new evidence proves otherwise, despite the Delaney Clause’s explicit ban on carcinogens in food. Under the law, the FDA must revoke approvals for additives identified as carcinogenic by authoritative bodies such as the National Toxicology Program or the International Agency for Research on Cancer.
• The FDA will not conduct evaluations for chemicals it deems to have “insufficient evidence” of harm. Many chemicals fall into this category simply because they have not been sufficiently studied. By default, the FDA will treat all such chemicals as low concern even when they are very likely to carry risks. This is particularly alarming for the large number of secret GRAS chemicals in our food.

• The new program does nothing to change the FDA’s ongoing practice of ignoring its legal obligation to consider the cumulative toxic effects of similar chemicals that cause the same harms. 

  Beyond these concerns, funding to implement the program will also prove essential to its ability to public health.