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FDA’s Dr. Keefe Requests More Information sharing at Keller and Heckman Seminar

Speaking at Keller and Heckman's 16th Annual Food Packaging Law Seminar, October 14, 2015, in Arlington, VA, Dr. Dennis Keefe, Director, Office of Food Additive Safety, U.S. Food and Drug Administration (FDA), stated that cooperation between the Agency and industry is necessary for food companies to gain the confidence of consumers. He added that FDA needs information about the safety of chemicals in a more-timely manner.

"Given FDA's limited resources, we have to be smart about how we allocate those resources," Dr. Keefe said. For example, he suggested that, if the Agency could post safety information in food-contact notifications (FCN) on its website, then less resources would be needed to respond to Freedom of Information Act (FOIA) requests.

Discussing some of the challenges that FDA faces, Dr. Keefe suggested that the Agency needs to look at some of the decisions it made 30 to 40 years ago and review them based on current scientific understanding. This includes updating risk assessments based on new data and information, applying new methodology for risk assessments, and updating the Redbook, he explained.

Dr. Keefe reported that FDA has cleared more than 1,170 food-contact substances (FCS) since the FCN program began in 2000, and has reviewed more than 100 FCN submissions in each of the four previous years. He advised attendees to make sure that FCNs are as complete as possible. With respect to food additive petitions, Dr. Keefe explained that the majority of those recently submitted to FDA are requests to revoke food additives. The Agency also is currently responding to Citizen Petitions to initiate FDA rulemaking to amend existing food additive or color additive regulations or to prohibit the use of a particular food ingredient.

FDA's finite resources could impact the FCN program, Dr. Keefe warned. "Since the FCN program only operates if it is fully funded, if I have to pull resources to respond to citizen petitions, I won't have money for the FCN program," he said, adding, "We need to find a better way to communicate food chemical safety."

Dr. Keefe also discussed stewardship, which involves: 1) consumers, who want safe and affordable food with a minimum amount of chemicals; 2) FDA; 3) industry, which wants a level playing field, safe food, and policies that promote the use of the best available technology; and 4) advocates, with diverse interests that may or may not be directly related to food safety. He emphasized that FDA regulations should reflect industry's current best practices and be based on the best available science, adding that FDA needs to have post-market resources to focus on actual versus hypothetical or perceived chemical risks.

Dr. Keefe concluded with a request that industry and other interested parties meet with FDA to discuss information sharing. He noted that the rewards of providing data to FDA are:

  • Continued assurance to consumers that use of chemicals in food is safe
  • FDA is better informed, and thereby better able to timely respond to real and imagined safety concerns
  • Increases likelihood for evidence-based risk assessments

Finite resources can be focused on ensuring the safe use of chemicals in food and premarket review program