FDA to Hold Apr 20 Meeting on FSMA Preventive Controls for Food Facilities
The Food and Drug Administration is announcing a public meeting on April 20, 2011 in Silver Spring, MD to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted Food Safety Modernization Act (FSMA). FDA will also be seeking public comment to inform its rulemakings and guidance documents on the issue.
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FSMA Requires Facilities to Have Hazard Analysis & Preventive Controls
For the first time, the FSMA gives FDA a legislative mandate to require comprehensive, science-based preventive controls across the food supply. In particular, an owner, operator, or agent in charge of a facility that is required to register under section 415 of the FD&C Act (21 USC 350d) will have to take certain preventive actions, including to: (i) evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, and to (ii) identify and (iii) implement preventive controls to significantly minimize or prevent the occurrence of such hazards.
Importers Can be Considered Facilities & Must Ensure Suppliers Have Controls
Note that facilities required to register under 21 USC 350d include any factory, warehouse, or establishment (including those of an importer) that manufactures, processes, packs, or holds food for consumption in the U.S. In addition, the FSMA requires importers to assure through a “foreign supplier verification program” that its foreign suppliers produce food in compliance with the FSMA hazard analysis and preventive controls, among other things.
FDA Must Issue Regulations & Guidance on Preventive Controls
FDA is required to develop regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting their implementation. In addition, FDA is required to issue guidance with respect to hazard analysis and preventive controls. Given the diversity of registered facilities and regulated foods, FDA will use the guidance to assist the food and feed industries in complying with the preventive controls regulations, when they are finalized.
Seeks Info on Existing Facility Controls to Inform Its Rule and Guidance
FDA will leverage, where appropriate, best practices for hazards and controls identified by industry for specific types of food and feed and specific methods in manufacturing, processing, packing, and holding food and feed. Therefore, FDA will be seeking information on preventive controls currently used by facilities to identify and address hazards associated with specific types of food and specific processes to inform the development of its guidance and regulations.
Registration Needed to Attend, Live Webcast & Transcript Also Available
Registration is necessary to attend the meeting. In addition to being able to attend the meeting in person, FDA will be offering a live webcast of the event available here. FDA will also be posting a transcript of the meeting here as soon as it is available.
(See ITT’s Online Archives or 03/31/11 and 03/11/11 news, 11033124 and 11031125, for BP summaries of similar public meetings FDA held on the import provisions of the FSMA and on FDA’s use of international comparability assessments.
See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA, including the provisions on facility preventive controls.)
(FR Pub 04/13/11, D/N FDA-2001-N-0251)