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On Friday, January 4, 2013, FDA proposed new rules designed to prevent foodborne illnesses.  The proposed rules implement the Food Safety Modernization Act (FSMA) and are part of FDA’s strategy to change food safety from reactive to preventative. 


CGMPs and Preventive Controls 


The first proposed rule seeks to: modernize the Current Good Manufacturing Practices regarding manufacturing, processing, packing, or holding of human food; implement risk-based preventative controls; and define or clarify terms used throughout the impacted regulations.  The rule would require makers of food sold in the United States to maintain a formal food safety plan, perform a hazard analysis, and institute preventive controls for the mitigation of hazards.  The rule would also require the facilities to have a “qualified individual”—someone with requisite training or experience—prepare, monitor, document, and assess the effectiveness of their plans and controls.  The proposed rule revises the current 21 CFR Part 110 and creates a new 21 CFR Part 117.  FDA has proposed that many food manufacturers would be required to comply with the new preventative measures one year after the final rules are published in the Federal Register.  However, small and very small businesses would be allotted additional time to comply. 


Produce Safety Standards


The second proposed rule focuses on produce safety.  The rule proposes enforceable science- and risk-based safety standards for farms that produce and harvest fruits and vegetables.  Specifically, the rule would impose new standards on farms in these major areas: worker training, health, and hygiene; agricultural water; biological soil amendments; domesticated and wild animals; equipment, tools, and buildings; and sprouts.  The rule would also define or clarify certain terms.  For example, the term “produce” would be redefined to clearly encompass more foods, including mushrooms, tree nuts, and herbs.  FDA estimates that implementation of the proposed rule would prevent 1.75 million foodborne illnesses, with an associated benefit of $1.04 billion, annually.  FDA has proposed that larger farms would be compliant within 26 months after the final rule is published in the Federal Register.  Small and very small businesses would have additional time to comply.


Comments on the proposed rules must be submitted by May 16, 2013.  View the proposed rules here and here.  According to Michael Taylor, FDA’s Deputy Commissioner for Foods, it may take up to a year for FDA to review all comments and issue final rules.


Contact Us


For more information on these proposed rules or for assistance in commenting on these proposed rules, please contact David GrahamRanelle LeierMark Schneebeck, or Cynthia Wingert.

This alert is a copyrighted publication produced by Oppenheimer Wolff & Donnelly LLP. The information contained in this alert is of a general nature and is subject to change. Readers should not act without further inquiry and/or consultation with legal counsel.