The Food Safety Modernization Act, signed into law in January 2011, calls for new preventive control provisions to take effect July 3, 2012. The Food and Drug Administration, however, is still drafting the regulations that will govern implementation, and members of the food industry, including IDFA, have urged the agency to issue updated guidance concerning the timeline for enforcement.
In a letter sent yesterday to Michael Taylor, FDA deputy commissioner for foods, IDFA and 16 other food organizations said the fast-approaching date, combined with the lack of regulations and an official statement from FDA on enforcement, have generated uncertainty and concern among food companies.
The uncertainty is compounded for small businesses, the groups said. According to the law, the preventive controls provision will not take effect for small and very small businesses until FDA issues final regulations that define "small business" and "very small business" and outline the preventive control requirements.
"We understand the agency has stated informally that the FDA will not enforce these new requirements until the agency issues final regulations and allows time for implementation by the food industry," the letter said. "That makes perfect sense, but because of the way the law is drafted, it is essential that the agency state, in writing, that this will be its enforcement posture."
In joint comments filed a year ago, IDFA and the National Milk Producers Federation urged FDA to consider existing preventive control programs when drafting regulations for implementation. They also asked the agency not to mandate finished product testing, to align new regulations with the Pasteurized Milk Ordinance (PMO) and to focus on the validation of pasteurization systems, not finished products, to ensure public health and safety.
For more information, contact Clay Detlefsen, IDFA vice president of regulatory affairs, at firstname.lastname@example.org.
Upcoming Webinar: FSMA & the FDA Inspection Process
IDFA will host a free webinar, "FSMA & the FDA Inspection Process," on June 19 from 1:00 to 3:00 p.m. The webinar will help member dairy companies understand the rule changes that have already taken place, the ones that will occur in the near future and others that will occur this summer.
The "FSMA & the FDA Inspection Process" webinar will feature food safety expert Joseph A. Levitt, a partner in the Washington, D.C., office of Hogan Lovells US LLP. Before joining the firm in 2004, Levitt worked at FDA for 25 years, where he served as director of FDA’s Center for Food Safety and Applied Nutrition from 1998 through 2003. He currently serves as outside regulatory counsel to IDFA.
Participation in the webinar is free, but registration is required. For webinar information, contact Patrick Crosson, IDFA meetings registrar, at email@example.com or (202) 220-3524.