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FDA's Proposed Rule to Implement FSMA's Hazard Analysis and Risk-Based Preventive Controls: Implications for Manufacturers of Food-Contact Materials

February 14, 2013

The U.S. Food and Drug Administration (FDA) issued its long-awaited proposed rule to implement Section 103, "Hazard Analysis and Risk-Based Preventive Controls," of the FDA Food Safety Modernization Act (FSMA) on January 4, 2013. (78 Fed. Reg. 3646-3824) As applied to food-contact material manufacturers, the proposed rule has little direct impact.

The proposed rule requires most registered food facilities to maintain a food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of those hazards. Because facilities manufacturing only food-contact materials are not subject to FDA food facility registration requirements, they also are not subject to this proposed rule. Of course, this rule will significantly impact the customers of food-contact material suppliers; below is a summary of those impacts as they may affect food-contact materials.

As applied to registered food facilities, this rule proposes two primary changes: (1) revising and recodifying the current good manufacturing practices (CGMPs) found in Title 21 of the Code of Federal Regulations (C.F.R.) Part 110; and (2) establishing the hazard analysis and risk-based preventive control (HARPC) provisions regarding the development and maintenance of a written food safety plan and the implementation of preventive controls for the mitigation of those hazards that are reasonably likely to occur.

Applicable good manufacturing practices relative to the production of food-contact materials are set forth at 21 C.F.R. Part 174.5 ("General provisions applicable to indirect food additives"). The proposed rule does not make any changes to this regulation nor does the proposed rule address or directly impact the GMP plans or industry standards that manufacturers of food-contact articles or components of food-contact articles should observe to ensure that their products are suitable for use in contact with food. The rule is only applicable and relevant to companies dealing with preparing and storing food and food ingredients and the handling of food-contact materials within those facilities.

Under the proposed rule, the food CGMP regulations, currently at 21 C.F.R. Part 110, would be revised and recodified into a new Part 117. FDA proposes that all provisions of current Part 110 that would be incorporated into new Part 117 would be applicable to food, food-contact surfaces, and, additionally, food packaging materials. The revisions, which add coverage of "food packaging materials" to certain regulations, do not impose substantive requirements on manufacturers of food packaging materials; instead, the revisions apply to the proper handling and safe maintenance of food-contact materials in food facilities to ensure that these products are not contaminated or result in the adulteration of food.

Like the provisions relating to CGMP, the HARPC provisions of the proposed rule also only apply to a "food facility" that is required to register with FDA, and thus are not applicable to manufacturers of food-contact materials. In some cases, these provisions could indirectly impact food-contact material suppliers, as registered facilities develop written food safety plans and consider potential hazards that might relate to their packaging activities; packaging material suppliers may then be requested to assist in developing plans to avoid some of these hazards.

The regulations will be effective 60 days from publication of the final rule, but the general compliance date would be one year after the effective date, with additional time for small businesses (two years after the effective date) and very small businesses (three years after the effective date). FDA requests comments on the proposed approach and provisions by May 16, 2013.

FDA will also be publishing proposed regulations regarding the Foreign Supplier Verification Program (FSVP) for importers and Accredited Third Party Certification in the near future. Because of the way FSMA was drafted, there could be some impacts on food-contact materials suppliers under the FSVP.