Comment Period Extended For Proposed FSMA Rules

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Yesterday, the Michigan Department of Agriculture and Rural Development hosted officials from the Food & Drug Administration at a "Listening Session" on the newly proposed rules under the Food Safety Modernization Act (FSMA), namely the Preventive Controls for Human Food and the Produce Safety Standards. These proposed rules were published in January 2013 and are currently subject to comment by industry. This "Listening Session," which I attended via webinar, was helpful in many ways, including providing an opportunity to ask questions of and provide informal comments to the FDA officials. 

As we're learning, and as was evident in part by the discussion at the "Listening Session," these proposed rules represent a substantial overhaul of the structure of food safety regulation and will undoubtedly have a significant impact on the operations and "bottom lines" of Michigan's great food processing, agribusiness and farming businesses. I urge you to examine these proposed rules in depth, as they most certainly impact your business, and to participate in the comment period, either on behalf of your organization or as part of an association.  Participating in the comment period will allow you the opportunity to shape policy in this area, eliminate or limit vagaries or "gray areas" in the final rules, and give you standing to later argue against these rules in court.

Participating in the comment period will allow you the opportunity to shape policy in this area, eliminate or limit vagaries or "gray areas" in the final rules, and give you standing to later argue against these rules in court.

That last comment – participating in the comment period will give you standing to later argue against these rule in court – can be an important, albeit oftentimes overlooked, strategy in shaping policy. Failure to comment can have real ramifications, as evidenced by the recent U.S. Court of Appeals holding in Koretoff v Vilsack (decided in February 2013). In that case, a group of almond producers brought an action challenging the USDA's rule requiring that almonds produced in California be pasteurized or chemically treated to prevent salmonella outbreaks. The court held that the producers failed to preserve their arguments about the USDA's lack of authority and waived those claims because the producers failed to raise them during the notice and comment period. In other words, the producers forfeited their opportunity to challenge the rules in court because they didn't participate in the notice and comment period. I urge you to take that into consideration as you examine the impact of these proposed rules on your businesses.

FDA has now extended the comment deadline – which will now end on September 16, 2013

Because there has been an outpouring of requests by industry to extend the comment period (it was set to expire on May 16, 2013), FDA has now extended the comment deadline – which will now end on September 16, 2013. This provides industry additional time to review and evaluate the proposed rules, and to provide input to FDA if appropriate.

All of this is further complicated by the recent lawsuit against the FDA criticizing it for violating FSMA by not issuing all the required rules in accordance with the schedule and deadlines described in FSMA. After all, the proposed rules discussed above were issued one year past the deadline described in FSMA, and there are several other rules that are similarly past their due dates. On April 22, 2013, the California federal court hearing that case issued its decision ordering the FDA to come up with new deadlines for these FSMA rules by May 20, 2013. It is unclear how that court order will affect FDA's process in rulemaking.

If you have questions or comments about FSMA, or want assistance in examining its effect on your business and in developing a strategy for participating in the comment period, please contact me at sskluting@varnumlaw.com or 616-822-4613.

 

Topics:  FDA, FSMA, Proposed Regulation, Public Comment

Published In: Agriculture Updates, General Business Updates, Consumer Protection Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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