FDA delays inspections under FSMA animal food rule

FDA not beginning inspections for hazard analysis and risk-based preventive controls portion of Food Safety Modernization Act animal food rule until fall of 2018.

Food & Drug Administration Center for Veterinary Medicine director Dr. Steve Solomon announced Aug. 10 at a meeting of the Association of American Feed Control Officials (AAFCO) that the agency will not begin inspections for the hazard analysis and risk-based preventive controls portion of the Food Safety Modernization Act (FSMA) animal food rule until the fall of 2018.

The announcement was made to an audience of roughly 400 industry officials participating in the AAFCO annual meeting in Bellevue, Wash.

Previously, feed facilities were expected to be in compliance and ready for inspections by Sept. 18 — something the feed industry has pushed back on, given the short lead time for the facilities to conduct the necessary actions in order to be in full compliance. FDA’s inspection delay also means that the animal food inspections for the Foreign Supplier Verification Program final rule will be delayed until next fall. Both of these items apply only to large firms with more than 500 employees.

The American Feed Industry Assn. (AFIA) and the National Grain & Feed Assn. (NGFA) commended FDA on the delay.

Richard Sellers, AFIA’s senior vice president of public policy and education, who was participating in the meeting this week on the association’s behalf, said, “Producing safe, nutritious food in compliance with the law is the animal food industry’s number-one priority. However, given FSMA’s far-reaching and expensive regulatory impact that extends into all areas of our members’ business operations, we have been asking the Administration and Congress to provide a reasonable time frame so that our members can conduct the necessary actions they need and dedicate new resources to come into full compliance with the law. We feel that by providing a more reasonable deadline, FDA and its field staff will be able issue guidance documents that fully address our members' questions so that, no matter the size of the facility, the industry will understand their responsibilities in preparing for compliance. We appreciate the FDA recognizing the industry’s concerns of the amount of work that must be done and look forward to continuing to work together to achieve compliance.”

"We believe it is both prudent and appropriate for FDA to delay inspections of this portion of the FSMA animal food rule to provide additional time for FDA to develop and issue guidance - which now isn't expected to begin until early next year - and to enable companies to focus on implementing the current good manufacturing practice provisions, which form the foundation of an effective animal food safety plan and which for the first time will apply to all animal food manufacturers," said NGFA senior vice president for feed services David Fairfield. "The NGFA continues to receive questions from member companies about certain aspects of the hazard analysis and preventive controls requirements that need to be addressed by FDA through guidance, and this extension of the inspection date will be useful in improving the prospect for successful education, training and inspection efforts to bring about compliance."  

During his AAFCO remarks, Solomon also provided an update on the agency's work to publish guidance on the FSMA animal food rule, stating the agency hopes to issue final current good manufacturing practice (CGMP) guidance by the end of this year and the first portion of draft preventive controls guidance by "early" next year. FDA's guidance for the preventive controls will consist of several separate documents, with the first document addressing food safety plans, hazard analysis, animal food hazards, preventive controls and preventive control management components.

In addition, consistent with the delay of inspections for the preventive controls requirements, Solomon said FDA will not start inspections at animal food entities covered by the FSMA-related foreign supplier verification program (FSVP) rule until the fall of 2018. Solomon stressed that importers of foreign animal food products should be working now to obtain their Data Universal Numbering System (DUNS) number as part of complying with the new requirements.

In a related development, FDA recently provided more information about upcoming FSMA compliance dates. In a question-and-answer article posted on the agency's website, Jenny Murphy, consumer safety officer at FDA's Center for Veterinary Medicine, explained what animal food facilities can anticipate in the next phase of implementation. Murphy noted there will be an increased level of FDA oversight of CGMPs with more routine inspections occurring after the September compliance date. The Sept. 18 date is when small animal food facilities (facilities that are part of a company with less than 500 employees) are to be in compliance with the CGMPs. FDA expects to conduct at least 500 animal food CGMP inspections during fiscal year 2018, which runs from Oct. 1, 2017, through Sept. 30, 2018. While large companies also will be required to meet the preventive controls requirements on Sept. 18, she noted FDA will not be conducting routine regulatory inspections for those requirements until the fall of 2018.

 

 

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