Specialty Food Magazine

Summer 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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125 BY RON TANNER T he Food and Drug Administration's implementa- tion of the Food Safety Modernization Act is not yet complete. The last of the foundational rules, dealing with Intentional Adulteration, has been published. FDA hosted a public meeting to explain its impact to indus- try on April 17 at the FDA offices in College Park, Md. Simply, the IA Rule establishes requirements to prevent or sig- nificantly minimize acts intended to cause widescale public harm. It covers all facilities that manufacture, process, pack, or hold human food. Facilities must create a Food Defense Plan that details vulner- ability to intentional adulteration, the strategies to combat that vulner- ability, and how the company will monitor and verify those procedures to make sure they are effective. Compliance dates are staggered based on business size. Large businesses, defined as businesses with more than 500 employees, had an original compliance date of July 2019, with the date for small busi- nesses (less than 500 full-time equivalent employees) set for July 2020. Very small businesses, defined as those with less than $1 million in revenue, are exempt from the rule, although they do need to file docu- mentation proving they are a very small business. FDA is expected to extend those compliance dates. The Need for a Food Defense Plan The FDP is a set of written documents based on food defense prin- ciples. It incorporates a vulnerability assessment, mitigation strategies, and delineates food defense monitoring, corrective action, and verifica- tion procedures to be followed. The FDP must include: • Vulnerability assessment • Mitigation strategies and explanations • Food defense monitoring procedures • Food defense corrective action procedures • Food defense verification procedures • Owner/operator signature The FDP must be put together by a Qualified Individual, defined in the Preventive Controls for Human Food regulations as "an 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 develop and apply a food safety system." FDA recommends that manufacturers put together a Food Defense Team, which could include people from security, main- tenance, food production, sanitation, etc. Conducting a Vulnerability Assessment The first step is to conduct a vulnerability assessment, to look at each point, step, or procedure to identify the highest risk for adulteration. It should focus on people and places where they come directly in contact with the food. A facility must analyze the potential public health impact, degree of physical access to prod- uct, and the ability of an attacker to successfully contaminate the product(s). Inside attacks are more likely than adulteration from the outside. There are three methods recommended by FDA to do a vulnerability assessment—Key Activity Types, 3 Fundamental Elements, and the Hybrid Approach. The Key Activity Types and general categories of manufac- turing that have been identified as most vulnerable to intentional adulteration include: • Bulk liquid receiving and loading • Liquid storage and handling • Secondary ingredient handling • Mixing and similar activities Manufacturers are expected to analyze each point, step, or pro- cedure related to these key activity types to see where intentional adulteration could occur and to develop and implement a plan so that does not happen. The plan must be written. Building a Food Defense Plan: What You Need to Know FALL 2017 article bug 125 SUMMER 2019 specialty food maker

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