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Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Comments Regarding: Docket No. FDA 2013 N0590 “Implementation of the Food and Drug Administration’s Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act” The National Restaurant Association (Association) is pleased to provide the Food and Drug Administration (FDA) with comments regarding the amendments to the Reportable Food Registry as part of implementation for the Food Safety Modernization Act (FSMA). The Association, founded in 1919, is the leading business association for the restaurant industry, which is comprised of 925,000 restaurant and foodservice outlets and a work force of 13.1 million employees - making it the cornerstone of the economy, career opportunities and community involvement. Reflective of the industry, the Association’s membership is diverse, comprising large chains to small independently operated restaurants. Along with the National Restaurant Association Educational Foundation, the Association works to represent, educate and promote the rapidly growing industry. We commend FDA on the development of regulations to implement the many elements of the Food Safety Modernization Act (FSMA). We appreciate that the process is a challenging one, and the thoughtful approach used in issuance of an advanced notice of proposed rulemaking instead of a proposed rule is an appropriate one. FSMA allows FDA to require that a responsible party be allowed to submit to FDA consumeroriented information regarding certain reportable foods. FDA is seeking guidance regarding the scope and implementation provisions for the mandate from FSMA and how it affects the operation of the Reportable Food Registry (RFR). We provide comment on important aspects of the FDA request contained in the Advanced Notice of Proposed Rulemaking. (1) FDA should limit the scope of implementation to reportable foods that have entered the retail marketplace. In order to avoid consumer confusion, FDA should limit the scope of the FSMA requirement to reportable foods that have entered the retail marketplace and are directly offered for sale to consumers. Reportable foods that are ingredients for manufacturing or are bulk commercial products intended for further manufacturing should not be included in the scope of any proposed rulemaking that affects the RFR. These ingredients and in-process materials are already adequately covered under the rules governing the RFR. The declaration of scope that includes such materials would lead to consumer confusion from excessive warnings that do not impact consumers and for which they have no control. The RFR is an important tool for FDA, for industry, and for protection of the public health. Its effectiveness should not be diluted by
unnecessary expansion of its scope. While FDA must address the requirements of FSMA, the robustness and integrity of the RFR must remain. (2) FDA should declare the definition of “Grocery Store” to include establishments that sell groceries directly to consumers as part of the retail marketplace, and not include food service establishments. In the ANPRM, FDA asks for guidance in defining the term “Grocery Store” where any pending rulemaking would be in effect. The Federal Food, Drug, and Cosmetic Act does not define the term, “Grocery Store”. The purpose of the RFR is to control and prevent entry of adulterated foods into commerce, including its distribution to food service establishments. Mechanisms for communication to food service establishments of RFR-impacted foods and food ingredients already exist and are sufficient to protect the public health. Regulations regarding the RFR already require such communication, such that establishments receiving adulterated products are made aware and take appropriate action to control the affected products and prevent their entry into the consumer food supply. There is no evidence that a definition of “grocery store” that includes food service operations would benefit the FDA, or would in any way better protect the public health. Indeed, if food service operations were to be included in the definition of “Grocery Store” for this purpose, there would be widespread confusion. Consumers would not be served adulterated foods in food service establishments that are involved in the RFR, and would have no have no course – nor reason - for responding to the information that would be required to be offered. Conclusions We respectfully submit these comments to FDA on behalf of the Association. The Association supports FSMA and its elements designed to improve the public health. Any proposed rulemaking emanating from this ANPRM on consumer notifications relating to the RFR should be limited to foods that have entered the retail marketplace, and should not include food ingredients or bulk commercial products that are used in further manufacturing. FDA should also clearly exclude food service operations in their definition of “Grocery Stores” as part of FSMA implementation. Sincerely,
Christopher T. Melchert, REHS, CFSP Senior Manager, Food Safety & Quality Assurance National Restaurant Association
