Europe has focused on chemical risks for many years and that concern is now spreading more to North America. As part of this concern, FDA is continuing its regulatory focus on chemicals in food, this time adding three measures by which it intends to enhance its post-market reviews. The May 26 announcement of FDA’s “new approach to reviewing chemicals” in food follows the agency’s March earlier budget authority request which included $64M for its “health and Safety Food for All” program which includes its Closer to Zero plan and $5M increase (bringing the budget to $20M) for emerging chemical and toxicological issues.
Currently, FDA post-market reviews of chemicals used in, or in contact with, foods are based on data and information submitted through petitions or notifications or are initiated by FDA itself. The new approach for reviewing chemicals added to food, which is intended to build a “more modernized, systematic reassessment of chemicals,” adds three targeted post-market activities:
- Expand tools and methods for chemical safety reviews and assessments. Intended to “keep pace with scientific advances and technological innovations,” this would focus on chemicals in food and substances that come into contact with food. Goals for the initiative include:
- Expanding and integrating new IT to monitor the food supply and ingredients.
- Prioritizing chemical/substance evaluation through an expanded decision tree that sorts chemicals into classes of toxicity potential.
- Developing a comprehensive strategy to spur, and evaluate the potential of, new methodologies and technologies for regulatory use in food.
- Update reassessment determination processes. Determining if a chemical reassessment is warranted involves FDA identification, evaluation, prioritization, and communication of new and evolving information. The updates would include:
- Adding a framework for review to the safety reviews already in place and including a transparent process for identifying and prioritizing chemicals for review.
- Determining how to better obtain information on post-market use of chemicals rather than relying on voluntary submissions.
- Work with experts to update/enhance its approach to cumulative exposure assessment, including co-occurrence.
- Continue to monitor the food supply against chemical action levels, including:
- Strengthening industry compliance activities related to requirements for the safe use of chemicals as food ingredients, substances that come into contact with food, and substances that are Generally Recognized as Safe (GRAS).
- Expanding food supply surveillance by developing/updating analytical methods, enhancing contaminant-focused surveillance, and sharing sampling data.
- Develop a framework to monitor and detect signals of intentional chemical contamination and prioritize risk assessment, communication, and management.
- Develop a systematic approach to consider “feasibility and achievability” (e.g., manufacturer’s ability) when determining contaminant action levels.
- Continue to publish rules to increase efficiencies in the Food Additive Petition, Color Additive Petition and Food Contact Notification administrative processes.
In each of the three areas, FDA also plans to seek additional scientific and other stakeholder perspectives on the activities, processes, and tools and to improve transparency. However, despite the additional budget increase requests, the agency stipulates that the enhancements are “subject to additional resources,” stating, “Additional resources will be necessary for the agency to pursue some of these objectives and will help ensure more steady progress toward our goals.” Included in those needed resources, FDA lists: staff, expanded regulatory authority, and support from consumer advocacy groups, regulated industry, and Congress. With greater funding, FDA could establish a system for the routine chemical monitoring of post-market foods which, when combined with authorities to require industry to share data and information, would enable the agency to prioritize based on risk and better target resources toward prioritized chemicals.
It does seem that FDA food-related activities often come down to allocation of resources, though it’s not a surprise given the underfunding and issues that have evolved and come to light in recent years. It’s notable that FDA is also asking for more regulatory authority and there is an indication that the Agency will require industry to share findings that they are currently not required to share. But whether or not the agency has sufficient resources or will gain the authority to accomplish all the goals of the three target areas, FDA is focused on chemicals in food, and food businesses are wise to do the same.