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August 16, 2017

FDA Clarifies Relationship Between Juice HACCP and the Preventive Controls Rules, Announces FSMA Enforcement Delays

August has been an active month for the Food and Drug Administration (FDA), as the agency released guidance affecting juice processors and importers, announced enforcement delays for Food Safety Modernization Act (FSMA) regulations, and clarified which retailers are affected by the Sanitary Transport Rule.

Juice HACCP and Preventive Controls Rules

FDA released this month its Guidance entitled “Juice HACCP and the FDA Food Safety Modernization Act.” The Guidance, dealing with both juice processors and importers, addresses areas of the regulatory structure in which both Juice HACCP and FSMA’s cGMP and Hazard Analysis and Preventive Controls (PC) rules could apply. FDA also explains how the Foreign Supplier Verification Program (FSVP), Produce Safety, Food Defense and Sanitary Transport rules interact with Juice HACCP.

The agency expects juice processors to be exempt from the PC rules and that, even in cases of violations, FDA will not resort to FSMA principles but rather will take compliance action within the framework of Juice HACCP. Certain PC rules will continue to apply, however. These include using qualified personnel and meeting PC rules record-keeping requirements for personnel training. Because FSMA’s new cGMP rules have edited and merged the “staple” requirements of Juice HACCP these also will be binding on juice processors. 

FDA resolves the remaining overlaps generally in favor of processors already in compliance with Juice HACCP. Foreign products made under Juice HACCP are not subject to the FSVP rules (so long as the domestic processor also follows Juice HACCP) and, because produce bought for juice processing typically will be subject to microbiological controls during manufacture, farms selling to juice processors may be eligible for exemptions from the Produce Safety rules with respect to that produce. Lastly, while the Food Defense requirements may apply to many juice processors, the Sanitary Transport rules — because juice likely will be shipped in completely enclosed containers refrigerated against spoilage (as opposed to safety) — shouldn’t affect juice processors.

FSMA Facility Inspections Delayed

During the last week, FDA has announced its intention to turn a blind eye during facility inspections for a raft of FSMA programs. Center for Veterinary Medicine (CVM) Director Dr. Steven Solomon announced at the August 10th, 2017 AAFCO meeting that FDA will not inspect animal food facilities for enforcement of preventive controls until fall/winter of 2018, though large animal feed facilities are still required to comply with the Animal Food Preventive Controls Rule by September 18, 2017. However, if FDA performs a facility inspection — especially consequent to a recall — the agency will likely inspect the Food Safety Plan and “assess” what controls have been implemented at the facility. The agency also will not routinely inspect animal food importers for FSVP compliance or food facilities for preventive controls compliance for human food byproducts used for animal food.

Finally, in a post to the agency’s website, FDA confirmed that it will delay enforcing the preventive controls requirements for distillers and brewers furnishing (unprocessed) byproducts to animal food manufacturers.

Clarification on the Sanitary Transport Rule

Responding earlier this year to multiple requests from industry, FDA granted exemptions from the Sanitary Transport Rule for businesses typically covered by variations of FDA’s model Food Code. One such business — a “retail food establishment” — could be understood to include retail establishments selling food for animal consumption. FDA has now, as of August 14, 2017, clarified that retail animal food establishments are not included in the waiver because such establishments do not ordinarily fall under the Food Code; mixed human/animal food retail establishments do, however, receive the exemption.

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