Specialty Food Magazine is the leading publication for retailers, manufacturers and foodservice professionals in the specialty food trade. It provides news, trends and business-building insights that help readers keep their businesses competitive.
Issue link: https://www.e-digitaleditions.com/i/1194330
Throughout the first five years of FSMA, the FDA's rallying call was "Educate before we regulate." It has now changed to "Regulate while we educate." Bass said, "We have been working to train our inspectors and our state regulatory partners to do Preventive Controls and Foreign Supplier Verification Inspections. All FDA inspectors have been required to complete the FSPCA training as well as augmented FDA training. We now have a trained staff that can oversee industry's compliance with FSMA." The FSMA inspections take time. A Limited Scope Preventive Controls inspection requires three to four days at the facility; a Full Scope Preventive Controls inspection is four to five days. FSVP inspections take a little less time but still require multiple days. Many of the facilities inspected for Preventive Controls fail. In 2018, Voluntary Action Indicated (VAI) was reported in 2,295 facilities and Official Action Indicated (OAI) in 81 facilities during the Limited Scope Inspections. Facilities undergoing Full Scope inspections recorded 229 VAIs and 42 OAIs. Citations were issued for the following: • Lack of Hazard Analysis and Identification of Hazard • Lack of a Food Safety Plan • Lack of Sanitation Controls Verification Procedures: Establish and Implement • Lack of Process Controls Monitoring Procedures: Establish and Implement • Lack of Identifying and Implementing Preventive Controls FSVP Still a Mystery to Importers Sharon Mayl, senior advisor for policy in the Office of Food Policy and Response, reported on FSVP. Mayl co-led the team that developed the FSMA import rules and guidance documents. Even though FSVP inspections are pre- announced, many importers still fail. FDA has never had inspection authority over the import community and many importers are either confused or not paying attention to the law. They failed for the following reasons: • No FSVP • No written hazard analysis • No documented appraisal of the supplier Mayl stressed that certification by a third party, such as GS1 or SQF, is not sufficient to comply with the FSVP regulation. FDA has not recognized the equivalency of third-party certifiers. This concerns many in the international community. In 2019, FSVP inspections resulted in 296 No Actions Indicated, 518 VAIs, and 20 OAIs. The OAIs resulted from re-inspections after the importer failed the first inspection. FDA has issued its first Warning Letter for an FSVP violation in relation to a tahini from Palestine that caused a salmonella outbreak in the U.S. Mayl added that 1,400 FSVP inspections are planned for 2020. The Final Rule: Intentional Adulteration The Intentional Adulteration Rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts could cause illness, death, and economic disruption of the food supply. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in registered food facilities. Facilities must prepare and implement food defense plans. The written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification. A reanalysis is required every three years or when certain criteria are met. All employees who work at a facility and are in contact with food preparation must go through food defense awareness training to acquaint themselves with the possibility of intentional adulteration and how it could happen. The training offered through FSPCA is online and takes about 30 minutes to complete. The hand-holding period for FSMA is over. FDA is regulating while educating and expects the industry to comply with these rules that protect public health. FSMA-Related Inspections 2017 2018 2019* Limited Scope Preventive Controls 721 6,630 14,690 Full Scope Preventive Controls 263 612 867 Foreign Supplier Verification Program 285 795 870 *as of October 1, 2019 The hand-holding period for FSMA is over. FDA is regulating while educating and expects the industry to comply with these rules that protect public health. WINTER Ron Tanner is vice president, education, government, and industry relations for the Specialty Food Association.