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Dairy Facts 2016

FDA Grants Enforcement Discretion for Several FSMA Provisions

Jan 10, 2018

The Food and Drug Administration announced last week that it will not enforce certain provisions in four Food Safety Modernization Act (FSMA) rules while it considers changes to the requirements and addresses stakeholder concerns. IDFA welcomes this announcement and agrees with the statement made by FDA Commissioner Scott Gottlieb, M.D., that the move will help reduce industry and government burdens as the agency works to provide flexibility in FSMA’s implementation.

The announcement covers certain requirements in the Preventive Controls for Human Food (PCHF) rule, the Preventive Controls for Animal Food (PCAF) rule, the Foreign Supplier Verification Programs (FSVP) rule and the Produce Safety rule.

Here are the most important updates for IDFA members.

Written Customer Assurances

FDA will still require food facilities to disclose to their commercial customers if a hazard has not been controlled for in the food they supply, so the disclosure statement requirement will be enforced. However, FDA will not require those customers to send written assurances back to the supplier confirming that they or an entity further down the supply chain will control the hazard, meaning the customer assurance requirement will not be enforced. 

“IDFA has long opposed the customer assurance requirement as it would be duplicative and very burdensome to implement,” said John Allan, IDFA vice president for regulatory affairs and international standards. “Commercial customers are already required to conduct hazard analyses and implement preventive controls, as appropriate, including implementing supply-chain programs, to ensure hazards are controlled, when and where necessary, before finished product is distributed for retail sale.”

Human Food By-Products for Use as Animal Food that Are Further Manufactured/Processed

Dairy companies will only have to comply with the PCAF rule requirements when they are conducting certain manufacturing/processing activities that are most likely to introduce hazards or impact the food safety profile of the human food by-product that has been separated to be used as animal food and thereby could require implementation of preventive controls.

IDFA and other dairy industry stakeholders had raised concerns about applying the rule to facilities that perform certain low-risk manufacturing and processing activities before storing or transporting human food by-products for use as animal food. The guidance aims to remedy this concern.

Food Contact Substances Under FSVP

FDA will no longer require companies that import food contact substances, such as packaging materials, to conduct preventive controls measures as required by the Foreign Supplier Verification Programs rule. FDA said that it already conducts extensive premarket review of these materials.  

“Overall, FDA repeatedly emphasizes that regardless of the exercise of enforcement discretion regarding these regulations, it will continue to enforce the statutory prohibition against the introduction or delivery of adulterated food in interstate commerce,” Allan said. “We encourage members to read the guidance thoroughly and to call IDFA with any questions.”

View FDA’s factsheet and guidance document.   

For more information, contact Allan at

IDFA members may log in to access a detailed memorandum on the FDA announcements prepared by Hogan Lovells US, IDFA’s outside legal counsel.

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