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Date ArticleType
1/8/2013 Press Releases
Regulatory Alerts: Food and Drug

 

Regulatory Alerts: Food and Drug

1.  Food and Drug Administration: Current Good Manufacturing Processes and Hazard Analysis and Risk-Based Preventative Controls for Human Food

On January 4, 2013, the Food and Drug Administration (FDA) released for public comment its proposed rule on preventive controls established by the 2011 FDA Food Safety Modernization Act (FSMA); this rule focuses on preventing problems that can cause foodborne illness.  The proposed rule on preventive controls applies to many domestic and foreign firms that manufacture, process, pack or hold human food. The rule proposes that firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. FDA is proposing that the requirements be effective one year after a final rule is published in the Federal Register. Recognizing that smaller businesses may need more time to comply with the requirements, FDA is proposing to allow two years for small businesses and three years for very small businesses to comply.

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. Activities within the definition of "farm" would not be subject to the proposed rule, and the proposed rule would clarify those activities. 

The comment deadline is May 16, 2013.

 

2.  Food and Drug Administration: Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption

On January 4, 2013, the Food and Drug Administration (FDA) released for public comment its proposed rule which proposes enforceable safety standards for the production and harvesting of produce on farms. FDA is proposing these standards as part of its implementation of the FDA Food Safety Modernization Act (FSMA). This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables.  These standards would not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance would be eligible for exemption from the requirements of this rule. The proposed rule would set forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards.

FDA expects that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated food.  The FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality. 

The comment deadline is May 16, 2013.

 

  • Advocacy contact: Linwood Rayford at 202-205-6533
  • Submit comments electronically to Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
  • Submit written submissions in the following ways: FAX: 301-827-6870 or Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.