Specialty Food Magazine

Most frequent reasons in the Limited Scope inspections were: 1. Pest Control 2. Personnel 3. Manufacturing, Processing, Packing, Holding - Controls 4. Sanitary Operations - Plant Maintenance 5. Equipment and Utensils - Design and Maintenance Foreign Supplier Verification in 2020 and Beyond The FDA's Acting Director of the Office of Enforcement and Import Operations, John Verbeten, provided an update on Foreign Supplier Verification Program activity. He said, "I have been involved with FSVP since its inception and have watched the rule grow into the important part of food safety that it is today." The final FSVP rule states that inspections can be done remotely but that "mission critical" inspections should be done in person. Verbeten said that education of the importer community will continue but that enforcement has begun, with many firms being inspected for the first time. FDA is being more lenient toward small and very small importers but expects them to comply with the law to make sure food entering the U.S. is safe. FSVP inspections are record inspections, so they have not been as affected by the pandemic as Preventive Controls inspections. In fiscal year 2020, FDA had planned 1,400 FSVP inspections, with 1,325 on human food and 75 on animal food. Inspections are up from 785 in 2018 and 870 in 2019. Verbeten added, "We have completed 93 percent of the planned inspections through utilizing our remote inspection protocol." Whereas there are 30,000 importers in the U.S. and only 1,400 have been inspected, that 5 percent represents 75 percent of the food coming into the U.S., according to Verbeten. The importer segment has been slowly adjusting to this new rule, which is the first time they have been impacted by FDA regulations and inspections. And more than half of those inspected have not met the requirements. In 2020, 73 firms were cited for OAI (Official Action Indicated) and 701 for VAI (Voluntary Action Indicated.) The majority cited for OAI had not complied with VAI citations previously issued. The five most frequent reasons for the citations were: 1. No Foreign Supplier Verification Program 2. Improper documentation of foreign suppliers 3. No written hazard analysis 4. No document evaluation conducted 5. No establishment of written procedures to ensure appropriate evaluation conducted FDA is planning 1,750 FSVP inspections in fiscal year 2021. Intentional Adulteration Rule in Play for Small Businesses All food facilities required to register under Section 415 of the Food, Drug & Cosmetic Act must comply with the Intentional Adulteration Rule. The rule covers facilities that manufacture, process, pack or hold human food, both domestic and foreign. It became effective for large businesses in July 2019, small businesses (less than 500 full-time equivalent employees) in July 2020, and very small businesses (less than $10 million in revenue) in July 2021. Very small businesses do not need to develop a food defense plan but they do need to supply records that prove that they have been a very small business for the past three years. Food Defense Awareness training is required for all workers and supervisors at actionable process steps. FDA's Director of Food Defense, Jon Woody, said that the FSPCA intentional adulteration training has been accessed by industry more than 144,000 times. Facilities are required to have a Food Defense Qualified Individual, who must prepare the Food Defense Plan, conduct an assessment, investigate and explain the mitigation strategies, and do a reanalysis of the program. FDA is currently conducting "Quick Check" inspections to see if facilities are complying with the Intentional Adulteration Rule. All large facilities are currently subject to inspections; inspections of small businesses will start in March 2021. Inspections have been added to existing inspections. There have been few comprehensive Intentional Adulteration inspections to date but that will change as the pandemic wanes and FDA is able to resume more normal activities. Ron Tanner is former vice president of education, content & advocacy for the Specialty Food Association. During the Ask the Expert Session with FDA's Glenn Bass, several themes emerged, including: Remote Regulatory Assessments • Inspectors are giving credit to companies for what is being done well; in-person inspections were focused on finding problems • Previous in-person inspections were not good news and caused anxiety • FDA reaches out to companies to let them know an inspection is voluntary, unless it is "mission critical" Regulator Training • All regulator training is remote • Opportunity to do more training on how to analyze documents rather than visually inspect facility FSVP Inspections • Law allows remote inspections for FSVP since it is document review • FDA expects to increase FSVP inspections in FY 2021 COVID-19 Precautions • Will only inspect facilities in states in yellow and green zones, not red zones • Most of U.S. is now in red zone • Inspectors have script to review with facilities in advance of inspection; i.e., are there any facility employees with COVID? Has there been an outbreak in the facility? New Administration • New administration will be supportive of food safety • Will be some delays in FDA activities and guidances due to administration change • Expects administration support for FDA's New Era of Food Safety initiative WINTER ƒ

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