FDA Announces Extensions and Draft Guidance for FSMA Regulation

It's extremely rare that if you are in the food industry you have yet to hear about the Food Safety Modernization Act (FSMA). With deadlines for FSMA's rules quickly approaching, news from the FDA is causing much uncertainty.

On Tuesday, the FDA extended specific FSMA compliance dates to address concerns about the practicality of compliance, and clarified technical issues for select provisions in four of the seven FSMA rules through guidance documents.

To clear up the confusion, AIB International is your source for guidance and assistance. Our experts understand there is no extension for the ENTIRE rules, however there are extensions for individual provisions within the rules.

Here are four rules with impacted provisions:

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
  • Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Here are the seven FSMA deadline compliance categories:

  • Customer Assurance: When a reasonably foreseen hazard is to be controlled by a downstream customer, there must be written assurances that make it clear who is responsible for hazard control.
  • Facilities that are solely engaged in packing and/or holding activities conducted on raw agricultural commodities(RAC), when:
  • The RACs are nut hulls, nut shells, and/or produce.
  • The facilities would qualify as secondary activities for farms, except the facility is not under the same ownership as the farm.
  • Certain facilities that color raw agricultural commodities.
  • Facilities that are solely engaged in the ginning of cotton.
  • Foreign Supplier Verification as it applies to food contact substances, such as packaging and process aids. Keep in mind that the compliance dates for the foreign facilities have not been extended, only that verification by the US importer has been extended.
  • Compliance with updated CGMPs for certain facilities producing Grade A milk and milk products
  • Agricultural water testing in the produce safety regulation

New Guidance Documents from FDA

In addition, the FDA released three documents to help manufacturers understand the changes.

Moving Forward With Implementation

If these provisions do not apply to your facility, you should continue moving full speed ahead with FSMA implementation. The path for FSMA compliance may be challenging, but the consequences rest on your shoulders. Let AIB International help map that path with our info-packed seminar, FSMA: Pathway to Compliance.      



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