Aug 23, 2016
FDA extends compliance dates, issues guidance for FSMA

FDA has extended some of the compliance deadlines for parts of the Food Safety Modernization Act (FSMA) and has issued draft guidance for a key portion of the law, the Produce Safety Rule.

The changes affect compliance dates for parts of the current good manufacturing practices and preventive controls rules for human and animal food, the Foreign Supplier Verification Program (FSVP) and the Produce Safety Rule. The changes allow more time for manufacturers to meet requirements related to assurances their customers must provide and more time for importers of food contact substances. It also allows other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specific issues.

The new compliance dates are:

  • For the provisions concerning written customer assurances, the earliest date to comply is Sept, 19, 2018 for the largest facilities. This applies to all of the rules mentioned above.
  • For facilities that only pack and/or hold raw agricultural commodities that are produce and/or nut hulls and shells, the earliest compliance date is Jan. 26, 2018.
  • Compliance dates for certain facilities that would qualify as secondary activities farms have been extended to Jan. 26, 2018 at the earliest.
  • Compliance dates for companies that are engaged in coloring raw agricultural commodities are now Jan. 26, 2018 at the earliest.
  • The new compliance date for food contact surfaces under the FSVP rule is May 28, 2019 at the earliest.
  • FDA said it was working on clarifying the agricultural water time frame under the produce safety rule, saying that farmers “have discretion in how they sample agricultural water to develop a microbial quality profile. They are allowed discretion as to both the number of samples they take in their initial survey, provided that the total is 20 or more samples. And they are allowed discretion as to the time period over which such samples are taken, provided that it is at least two years and no more than four years.”

Visit FDA’s FSMA deadline compliance page for more on the new dates.

Also released were new draft guidance to help industry comply with requirements of the preventive controls rule. This guidance document is available for public comment until Feb. 21, 2017. The guidance is intended to help farms and companies comply with specific segments of the rule, including drafting a written food safety plan, hazard analysis, preventive controls, monitoring, corrective actions, verification and associated records.

FDA said it would release additional chapters of the draft guidance for public comment as they are completed, and noted that all chapters of the draft guidance would be released by early 2018. The provisions in the final FSMA rules remain unchanged.


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