ARLINGTON, Va., Aug. 11, 2017 — The NGFA today commended the Food and Drug Administration (FDA) for its decision to delay until the fall of 2018 inspections of the hazard analysis and risk-based preventive controls requirements implemented under the Food Safety Modernization Act (FSMA).
FDA Center for Veterinary Medicine Director Dr. Steve Solomon on Aug. 10 announced the one-year delay from the upcoming Sept. 18, 2017, compliance date in place for large animal food facilities (facilities that are part of a company with 500 or more employees) during the opening day of the Association of American Feed Control Officials (AAFCO) annual meeting in Bellevue, Wash.
“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, 2017, 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.
The NGFA is active in conducting a series of training sessions designed for animal feed, pet food and feed ingredient companies subject to the FDA animal food rule’s CGMP and hazard analysis and risk-based preventive controls. The next course is scheduled for Sept. 26-28 at Kansas State University in Manhattan, Kan., offering accredited hazard analysis and critical control point (HACCP) training. FDA’s animal food FSMA rule requires that certain activities specified within the regulations be completed by a “preventive controls qualified individual.” This course, developed by the Food Safety Preventive Controls Alliance (FSPCA), is the standardized curriculum recognized by FDA, and is one way for affected companies to meet the requirement to have a “preventive controls qualified individual” on staff. Fairfield, who is a faculty member for the course, chaired the FSPCA work group that developed the training. Click on this registration link and scroll to the NGFA-KSU Food Safety Modernization Act Training course listings to access more information.