IDFA’s first Regulatory RoundUP opened this week with an impressive line-up of government  speakers representing several federal agencies. More than 75 participants packed the lunch and session rooms to hear the latest news on labeling, food safety, food defense, energy savings and school nutrition programs.

First up on Tuesday was Michael Taylor, deputy commissioner for Foods and Veterinary Medicine for the Food and Drug Administration. Taylor, who oversees the agency’s work on the Food Safety Modernization Act (FSMA), opened his keynote address by complimenting IDFA on the many helpful comments the association has filed and the dairy industry on its successful efforts to ensure food safety. While he discussed the rulemaking and implementation activities affecting all FSMA rules, he specifically addressed IDFA’s request to recognize the singular authority of the Pasteurized Milk Ordinance (PMO).

Commitment to PMO

Taylor underscored FDA’s commitment to the PMO, calling it the strong, unchanging, historic way that industry and government have worked together to assure the safety of milk for many years. He called pasteurization the ultimate preventive control and noted the strength of the NCIMS framework, which offers a federal-state cooperative program and a good model for collaborating with industry. Taylor said FDA is now assessing how to implement FSMA in a way that preserves and builds on the success of the PMO.

FDA is committed to avoiding new requirements that don’t make a practical difference to food safety, he said. In addition to getting the rules right, FDA must focus on how to work within the agency and with industry to get the best food safety and public confidence benefits.

Culture Change at FDA

FDA is undergoing a culture change, Taylor said, moving from a traditional approach focused on enforcement against violations to an approach that fosters compliance with standards and focuses on outcomes. The agency is considering how best to provide guidance, technical assistance and training support while conducting inspections that are flexible and more targeted based on risk.

In closing, Taylor mentioned the significant gap in funding and resources that will be necessary to implement FSMA. He said a new system based on compliance outcomes will depend on partnerships that uncover ways to leverage public and private resources to make it work.

Q&A Answers

Taylor also offered answers to several questions from the participants.

• The results of the milk sampling survey, which checked for antibiotic residues in milk, are still “in process,” although Taylor said the outcome is very reassuring about the safety of the milk supply. The question the agency is grappling with now is “what are the indications for how we continue to do our work to ensure that.” Although he didn’t mention a date, Taylor said FDA plans to release the results, with no surprises, as soon as it can.
• He acknowledged that the proposed changes to the Nutrition Facts panel will take time and money, so FDA is proposing a two-year implementation period. He encouraged processors to provide factual based comments with scenarios of what FDA should be doing.
• Regarding recent news reports that FDA is planning to release voluntary sodium reduction guidelines, Taylor said it is a high priority but not a new initiative. The agency has been working on sodium guidelines since 2010, when the Institute of Medicine report recommended that FDA work with the food industry to set targets for voluntary reductions with a gradual approach. He didn’t mention a specific timeline, but said the agency is in the process of getting them finalized.
• When asked about growing calls to ease restrictions on the sale of raw milk, Taylor emphasized that FDA will continue to express its concerns about increased public health risks from raw milk consumption.

For more information, contact Clay Detlefsen, IDFA vice president and regulatory affairs and counsel, at cdetlefsen@idfa.org.