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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99 BY RON TANNER Food Safety Update: FSMA Implementation and Inspection Time Is Here But the grace period is over. As FDA officials stated at the recent Food Safety Preventive Controls Alliance Conference in Chicago, their modus operandi for the past three years has been "Educate before we reg- ulate." The new approach is "Educate before and WHILE we regulate." FDA Perspective on Preventive Controls for Human Food The Preventive Controls for Human Food Rule took effect for large food manufacturers in September 2016. Small food businesses, with sales of more than $1 million but less than 500 employees, needed to comply in September 2017. And very small businesses with less than $1 million in food sales were required to comply in September 2018, or to inform FDA that they are a qualified facility. Qualified facilities are not exempt from the rules but they do have modified requirements. (see sidebar, p. 100) At the conference, Glenn Bass, deputy director west, Office of Human and Animal Food Operations, talked about FDA's key imple- mentation principles for the PC for Human Food rule. He stressed the following: • FDA will invest in regulator training and continuing education so that inspectors do inspect and make decisions consistently. • All regulators are taking the FSPCA course on Preventive Controls for Human Food. • Regulator-specific training has also been implemented. Bass noted that inspections have been limited over the past few years but that they are being stepped up in 2018. A comprehensive preventive controls inspection is much more extensive than the Good Manufacturing Practices inspec- tions that most manufacturers are accustomed to. For PC inspections, FDA will be examining a lot of records and inter- viewing staff along with physically inspecting the plant. The Food Safety Plan will be the main focus. This plan must be created by "a qualified individual who has successfully completed training in the development and application of risk- based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to devel- op and apply a food safety system." A s everybody in the specialty food industry (hopefully) knows, the Food Safety Modernization Act is almost entirely in effect. Originally passed by Congress in January 2011, it has taken nearly seven years for the Food & Drug Administration to inter- pret the law, listen to industry and other stakeholders, issue draft guidance, listen to industry and stakeholders again, and then publish final rules. Plus, small and very small businesses have been granted extensions as requested by the Specialty Food Association and others. For 2018, 400 Preventive Controls inspections were planned at the 94,000 registered U.S. food facilities, translating to just less than 0.5 percent being inspected. FALL 2017 article bug 99 WINTER 2019 specialty food maker

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