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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

A Bit(e) of Light Reading on the FSMA Rules

OK, folks, its time for participatory democracy.  There are a lot of pages to read and time to comment.  Here are the summaries:

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA’s current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.  Download All.

SUMMARY: To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) is proposing to establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is proposing these standards as part of our implementation of the FDA Food Safety Modernization Act (FSMA). 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. We expect that the proposed rule, if finalized as proposed, would reduce foodborne illness associated with the consumption of contaminated produce.
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DATES: Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013 (see the “Paperwork Reduction Act of 1995” section of this document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-N-0921 and/or Regulatory Information Number RIN 0910-AG35, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section of this document).

What I said from Take Part:

But Bill Marler, a Seattle attorney who specializes in food safety cases, tells TakePart that unless enforcement measures are knitted into the new rules, Americans shouldn’t expect to see foodborne illness eradicated anytime soon.

“You can set all the rules you want. The real question is—are all the players in the industry going to observe them? Where’s the mechanism to make sure the companies that might ignore them are caught before an outbreak happens?” he says.

“You need boots on the ground randomly testing and inspecting. The FDA doesn’t have the people power to do that. This is really not rocket science. Much of what they’ve done is completely commonsensical, but who is in those plants making sure the companies are doing what they’re supposed to be doing? That’s why you need inspections.”