Specialty Food Magazine

Winter 2019

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.

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100 ❘ SPECIALTY FOOD MAGAZINE specialtyfood.com The Food Safety Plan must include: • Hazard analysis • Preventive controls › Process, food allergen, sanitation, supply chain, and other › Recall plan • Procedures for monitoring • Procedures for corrective action • Verification procedures A facility overview, product description, flow diagram, and process description are useful components of the Food Safety Plan but are not required under the regulation. FDA says that an inspection for the Full Requirements of the PC for Human Food will require inspectors to be in a facility for four to five days. Facilities that are exempt from the full require- ments will still have the FDA present for three or four days. Bass noted that the initial focus of the PC inspections will be on supply chain and recall programs. Due to a lack of funding and staffing, FDA will not be doing PC inspections on a large percentage of manufacturing facilities. For 2018, 400 domestic inspections were planned at the 94,000 registered U.S. food facilities, translating to less than 0.5 percent being inspected. One hundred foreign inspections were expected at the 116,000 registered foreign facilities, or less than a 0.1 per- cent inspection rate. Thousands of facilities will continue to be inspected for Modernized Good Manufacturing Practices. FSVP Implementation and Inspections Sharon Mayl, a senior advisor for Policy with FDA's Office of Foods and Veterinary Medicine, reported on the implementation of the Foreign Supplier Verification Program at the FSPCA Conference. FSVP has been in effect since May 2017 for most U.S. import- ers. It is a sweeping program with the goal of making all food imported into the U.S. as safe as food pro- duced in the U.S. Importers are required to verify that the facilities that they purchase from are complying with the PC for Human Food regulations. The U.S. importer must review and verify the Food Safety Plan of all its suppliers. This must be done by a qualified individual (definition above) and extensive written records must be available for FDA to review at the importer's U.S. business address. FDA will initially be more aggressive in FSVP inspections than in PC. The inspections are pre-announced and evaluate com- pliance with the FSVP requirements. Although it is helpful to know that the FDA is coming, it is impossible to put together an FSVP program between the announced date and the day of the inspection. The FSVP inspection program began in June 2017. FDA is aggressively training its inspectors; as of July 2018, nearly 300 inspectors had been trained and more were being trained during the second half of 2018. According to Mayl, 2,275 FSVP inspections were planned for 2018. Only about 10 percent of those planned inspections had taken place as of July 2018. MODIFIED REQUIREMENTS FOR QUALIFIED FACILITIES A "qualified facility" is a very small business with sales of less than $1 million averaged over three years (currently 2015, 2016, 2017), adjusted for inflation. Qualified facilities must inform FDA of that status by December 18, 2018, by submitting form 3492a. Qualified facilities are subject to five parts of the FSMA regulations: • General provision, i.e., for training • Current Good Manufacturing Practices • Modified requirements that apply to qualified facilities: › Identify potential hazards, implement preventive controls and monitor › Are in compliance with state, local, county, or tribal food safety laws • Certain record-keeping requirements • Withdrawal of modified requirements if FDA deems appropriate Although many specialty food manufacturers may meet the definitions of a qualified facility, distributor and retail customers may require them to follow more stringent requirements than does FDA. It is impossible to put together an FSVP program between the announced date and the day of the inspection. More than 60 percent of the importers who were inspected did not meet the FSVP requirements. article bug specialtyfood.com ❘ SPECIALTY FOOD MAGAZINE 100 specialty food maker

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