Comment Period Extended For Proposed FSMA Rules

by Varnum LLP

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 or 616-822-4613.


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.

© Varnum LLP | Attorney Advertising

Written by:

Varnum LLP

Varnum LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.