Stephen Ostroff, M.D., deputy commissioner of food and veterinary medicine for FDA
Stephen Ostroff, M.D., the deputy commissioner of food and veterinary medicine for the Food and Drug Administration, made his second appearance as the keynote speaker for IDFA’s Regulatory RoundUP on Monday where he announced a new agency agreement with China that will benefit U.S. dairy exporters. Ostroff said FDA plans to sign a memorandum of understanding (MOU) with China on June 15 to exchange information that will give U.S. exporters continued access to the Chinese market for dairy products, seafood and infant formula.
Because China requires FDA to certify that U.S. dairy products meet Chinese food safety standards, the MOU provides a process for third parties to complete the necessary audits and allow FDA to issue the required export certificates. China is one of the fastest growing dairy export markets and the third largest market for U.S. dairy products.
FSMA Remains Foremost Priority
Ostroff opened his speech with an update on the Food Safety Modernization Act, noting the wide-ranging scope of the rules, implementation efforts and compliance dates. Citing FDA’s mantra, “Committed to educate before and while we regulate,” Ostroff said the agency recognizes that implementing the new food safety regulations is a learning process that will take some time.
He explained that 300 “educational inspections” will take place this year under the preventive controls rule, with inspectors visiting 240 domestic and 60 foreign supplier facilities. The inspections, he said, are meant to acknowledge what companies are doing well, as well as identify areas that companies can improve to come into compliance.
‘More to Come’
Ostroff also touched on several priority issues for IDFA members, indicating that there would be “more to come” from FDA on these topics.
- Regarding the domestic use of ultra-filtered milk in all standardized cheeses without declaring it on the label, he said, “We understand the issue and we’re working on it. All I can say is ‘more to come.’”
- For updates to standards of identity, he said, “More to come,” as the agency collects as much scientific information as is available and considers consumer perceptions about certain products.
- He gave a glimmer of hope to dairy companies asking for more time to comply with Nutrition Facts label changes, saying FDA is “closely considering” extension requests and there’s “more to come in relatively short order.” On Tuesday, FDA announced it would extend the compliance date but gave no timeline.
- He encouraged participants to submit comments on FDA’s draft guidance on “Control of Listeria monocytogenes in Ready-to-Eat Foods” before the July 26 deadline.
FDA Program Alignment
Calling FDA’s new program alignment “the most significant change in the way FDA does business in decades,” Ostroff outlined the agency’s recent reorganization efforts to align inspectors according to specialty, not geographic regions. Under the new program, only FDA inspectors with food experience will conduct the food facility inspections, providing more technical expertise and skill, more consistency in approach and more efficiency within FDA, he said.
NCIMS and Sampling Assignment Updates
On Tuesday, participants heard from John Sheehan, director of the division of dairy, egg and meat safety in FDA’s Center for Food Safety and Applied Nutrition. Sheehan opened his talk by listing the achievements from the recent National Conference for Interstate Milk Shipments conference and highlighting the successful collaborative efforts to integrate elements of the Food Safety Modernization Act into the Pasteurized Milk Ordinance, which governs Grade A milk products.
He also said the NCIMS pilot program for testing milk for tetracycline residues will begin July 1. He encouraged all companies to participate, saying, “the more data, the better.”
Moving to the topic of sampling assignments, Sheehan said two were recently completed, two are ongoing and a new one will launch in fiscal year 2018.
- The cheese assignment, covering 50 domestic makers of Mexican and Central American-style cheeses, evaluated the potential for Listeria monocytogenes and is complete.
- The assignment for dried dairy products is complete, but results are not yet available.
- The assignment among 100 ice cream and frozen novelty plants, which began last year, will be complete by the end of August. FDA is testing for Listeria monocytogenes and Salmonella and evaluating whether each company has sufficient procedures in place to prevent cross contamination and ensure food safety.
- As part of an ongoing assignment to comply with the European Union’s residue audit, FDA continues to sample retail milk products for various drug residues, pesticides, aflatoxins and heavy metals, but it will now be on a reduced scale.
- New in fiscal year 2018 will be a FSMA compliance verification assignment for non-Grade A plants. For plants that make both Grade A and non-Grade A products, only the non-Grade A products will be sampled.
For more information, contact Clay Hough, IDFA senior group vice president and general counsel at firstname.lastname@example.org or Emily Lyons, IDFA director of regulatory affairs and counsel, at email@example.com.