Today the government is scheduled to open a six-month public comment period on drafts of guidance documents that are designed to help food company operators meet new regulations — some of which have compliance deadlines in less than one month. With the publication of the first five out of 14 chapters of guidance documents today, the Food and Drug Administration is moving closer to implementing congressionally mandated rules described in the 2011 Food Safety Modernization Act (FSMA). The draft guidance documents and a final rule that “extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules” of FSMA are scheduled to be published in the Federal Register today, according to FDA officials who spoke during a news conference Monday. Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said Monday the deadline extensions are an example of the steps the agency is taking to make the FSMA rules practical for businesses while protecting public health. She pointed to the more than 600 meetings and listening sessions FDA had during the development of the seven FSMA rules as further evidence of the agency’s commitment to making sure the regulations are realistic and will be effective in reducing foodborne illnesses in the United States. The publication of the draft guidance documents today is another example of the FDA’s efforts to help business and industry comply with the new regulations, said Rebecca Buckner, FDA chief implementation manager for FSMA. “The remaining nine chapters of guidance documents will be released through 2018,” Buckner said Monday. She said a webinar on the five chapters published today is scheduled for Sept. 19. That’s also the date of the first compliance deadline related to FSMA regulations, with the largest food companies expected to have certain provisions of the Preventive Controls for Human Food rule in place at that time. Compliance dates for large food facilities that produce human and animal foods are:
- Human food companies other than small and very small businesses will need to come into compliance with the Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by Sept. 19; and
- Animal food companies other than small and very small businesses will need to come into compliance with CGMP under the Preventive Controls for Food for Animals rule by Sept. 19 and with preventive controls by Sept. 18, 2017.
“The changes announced in today’s final rule impact the compliance dates for certain provisions in these four rules: the two CGMP and Preventive Controls rules for human and animal food, Foreign Supplier Verification Programs, and Produce Safety,” FDA officials said in a statement issued before Monday’s news conference. “The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.” FDA’s materials specifically indicate the guidance published today “contains non-binding recommendations” and is a “draft — not for implementation.” Businesses and the general public can submit comments on the draft guidance for the next 180 days. “The draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan,” according to FDA’s statement. For additional information on the compliance deadlines, draft guidance and how to comment on it, please visit the following FDA web pages:
- Food Safety Modernization Act: Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules;
- Compliance Date Extensions and Clarifications for FSMA Final Rules; and
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food.
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