FSPCA conference highlights FDA FSMA-related activities
By David Fairfield, Senior Vice President, Feed
Officials from the U.S. Food and Drug Administration (FDA) provided updates on the agency’s Food Safety Modernization Act (FSMA)-related compliance activities during the 2021 Food Safety Preventive Controls Alliance (FSPCA) Virtual Annual Conference conducted Oct. 20-21.
Glenn Bass, deputy of human and animal food operations – west for FDA’s Office of Regulatory Affairs (ORA), provided the conference’s keynote address and gave details on the agency’s fiscal year (FY) 2021 (Oct. 1, 2020 – Sept. 30, 2021) inspectional activity, including:
• The number of inspections conducted by FDA was significantly curtailed due to the COVID pandemic – 486 domestic animal food current good manufacturing practice (CGMP) and preventive controls inspections during FY21 versus 850 during FY20.
• The most frequent animal food inspection citations related to:
--Failure to implement a preventive control;
--Inadequate hazard analysis;
--No food safety plan; and
--Inadequate environmental monitoring.
• 10 animal food inspections were conducted to evaluate compliance with FDA’s sanitary transportation requirements – all of these were “for-cause” inspections.
• FDA completed 1,666 Foreign Supplier Verification Program (FSVP) inspections compared to its target of 1,700 (FSVP regulations give FDA authority to conduct remote inspections; 60 FY21 FSVP inspections were focused on animal food).
• The most frequent FSVP citations noted during inspections were:
-- No FSVP plan developed;
-- No written hazard analysis;
-- No evaluation of supplier performance; and
-- Lack of supplier approval.
• Approximately 85 percent of FDA’s animal food inspections are conducted under contract by state-credentialled regulators.
• FDA has revised its approach for pre-announcing inspections due to the COVID pandemic, which initially provided for up to a five-day notice, so that inspections are now pre-announced as appropriate. In addition, FDA will not pre-announce inspections when they believe the firm’s compliance history warrants that no pre-announcement be made.
Highlights from the animal food breakout conducted during the conference included:
• FDA’s voluntary remote regulatory assessment (VRRA) program for its Veterinary Feed Directive regulations – a program in which animal food facilities can choose to voluntarily participate and share compliance information with FDA in a remote manner – will be continued in FY22. FDA’s evaluation of the pilot VRRA program conducted in FY21 was positive, and the agency believes the program can be beneficial to both FDA and industry program participants.
• FSPCA has previously issued a training resource – Abbreviated Guide to Creating a Livestock Food Safety Plan Under the Preventive Controls for Animal Food (PCAF) Rule and its accompanying Example Food Safety Plan – Medicated and Nonmedicated Feeds for Swine and Broilers – to assist animal food facilities in developing and implementing food safety plans. FSPCA encourages animal food facilities to take advantage of and utilize this resource.
• Detailed information on FDA’s animal food-related compliance activities may be accessed through the FDA Data Dashboard and FDA-TRACK: Agency-wide Program Performance.
• FDA will continue to use a comprehensive inspection approach in which it evaluates all applicable compliance programs (e.g., FSMA animal food CGMP and preventive controls, medicated feed, veterinary feed directive, bovine spongiform encephalopathy, etc.) during a single visit to a facility. This approach is intended to enhance the efficiency of the inspection process. Detailed information about the agency’s comprehensive inspection approach is available within FDA’s Comprehensive Animal Food Inspection Compliance Program Guidance Manual.
More than 200 food industry professionals participated in the 2021 FSPCA Annual Conference. FSPCA’s mission is to develop curricula, training and outreach programs to support FSMA compliance. NGFA has actively participated within the FSPCA since its inception in 2011, and David Fairfield, NGFA’s senior vice president, feed, currently serves on the FSPCA Executive Advisory Board and chairs its Animal Food Committee.