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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Phase 1: Publishing the rules Phase 2: Implementation Phase 3: Monitor, educate, refresh The FDA and the food industry are currently at the beginning of Phase 2. Wagner pointed out that the rules and inspections are systems based, not observation focused. There will be no one-size-fits-all inspections. The effect on public health will be the overriding factor in determining conducting inspections, and more time and effort will be spent focused on producers with a bad track record. There are four key requirements of the preventive controls, three of which are especially significant for the specialty food industry. (The fourth requirement involves farm operations.) They include: • Establish and implement a food safety system that includes an analysis of hazards and risk-based controls. • Establish a risk-based supply chain program for raw material and ingredients. • Clarify and update Current Good Manufacturing Processes. 1. Establishing a Food Safety System According to the rule, companies must create a written food safety plan. For companies with more than 500 full-time employees, that plan would be created and adopted at the corporate level, with imple- mentation at each facility. Small and very small businesses can create and implement the plan at the manufacturing site. The food safety plan must address hazard analysis and preventive controls. The first step in hazard analysis is identification, which must consider known or reasonably foreseeable biological, chemical, or physical hazards. The rule demands that hazards requiring preven- tive control be minimized or prevented through systems such as pro- cess, food allergen, and sanitation controls, as well as supply-chain controls, and a recall plan. A safe food supply is important and is supported by all in the specialty food industry. Since 2011, the FDA has been work- ing on the regulations and has conducted public hearings, taken written comments, and had face-to-face listening sessions with multiple stakeholders, including the Specialty Food Association. The Association has testified at six public hearings and had two listening sessions at the FDA offices in College Park, Maryland. Fourteen Association members have spoken to the FDA to put a "face" to the specialty food industry. The Association has been stressing the impact that the regulations will have on its member companies, and requested that the FDA make special considerations for small and very small businesses. The Final Rule for Preventive Controls for Human Food will have the most significant consequence on the specialty food industry. (Another important rule, one regarding import safety and foreign supplier verification, will also have an impact. That rule was released in November 2015, and will be addressed in the Spring 2016 issue of Specialty Food Magazine.) Based on input from the Association and other industry stakeholders, the FDA has granted an extension of the Preventive Controls rule for small and very small businesses. Whereas the rule becomes effective one year after publication—September 2016— for the majority of food businesses, small and very small businesses will receive an extension for compliance. The definitions of small and very small businesses and their corresponding extensions are as follows: Small businesses: Defined as companies with fewer than 500 employees; they have two years to comply Very small businesses: Defined as companies with annual sales of less than $1 million; they have three years to comply Although these extensions are good news for the specialty food industry, they are not exemptions, and producers need to start plan- ning now to obey the law. FSMA Implementation Update On Oct. 20, the FDA held a public meeting in Chicago to explain the final Preventive Controls rule. Roberta Wagner, associate director for FSMA Operations from the Center for Food Safety and Applied Nutrition, noted that there were three phases involved in FSMA implementation: Although these extensions are good news for the specialty food industry, producers need to start planning now to obey the law. The rules and inspections are systems based, not observation focused. There will be no one-size-fts-all inspections. The efect on public health will be the overriding factor in determining conducting inspections, and more time and efort will be spent focused on producers with a bad track record. (continued on p. 125) WINTER 2016 111