User fees and consequences if not approved; prior notice of imported foods; consumer information on reportable foods … With the seven rules proposed, FSMA focus has begun to turn to the particulars of guidance and implementation.
User fees are not a new topic, and FDA has been trying for the last several years to impose them on registered establishments – but so far without success. However, in an appearance before the House Appropriations Subcommittee last week, FDA Commissioner Dr. Margaret Hamburg discussed FDA’s FY 2015 budget request, which includes a $263 million increase over the FY 2014 enacted level for food safety, $229 million of which is intended to result from user fees, ($60 million in Food Facility Registration and Inspection fees and $169 million in Food Import fees).
Despite the FDA pushing for this the general consensus of the committee was that FDA should not expect the user fee monies to be forthcoming. “The committee cannot authorize user fee, and I think user fee legislation is virtually impossible,” said Chairman Robert Aderholt (R-Ala.). This is, at least in part, because the industry isn’t supporting the fees. Thus, Aderholt asked, “Why is the administration continuing to propose user fees … when the administration has no plan to work with industry on this?”
Hamburg replied that FDA is working with industry, because it has seen benefits in enhanced efficiency and predictability on the drug side with such fees. “But it is process,” she said, adding “In the meantime we have an important set of programs to implement, and it is a concern in terms of will we be able to get the full dollar amounts that we need to implement FSMA in the way congress asked us to.”
Noting that “the justification is a bit slim on the details,” Aderholt asked Hamburg to provide information on how the money would be spent in each area without duplication and why it is needed since final rules won’t be out until 2015.
Agreeing to come back to the committee with more detail, Hamburg said that the user fees would enable the Agency to undertake the activities needed to fulfill the goals of FSMA. With fiscal year 2015 and 2016 being critical for implementation, the Agency needs to begin now to hire, train, work with states, and conduct outreach, she said, adding that the budget authority request is a small piece of what will be needed, and the $580 million presidential request did include user fees.
While agreeing that it was unlikely that user fees would be approved, Representative Rosa L. DeLauro (D – Conn.) seemed to side with FDA on the need for monies – but, like other Committee members, wanted detail on exactly what FDA needs are. “I want to know what you need. User fees are fine, but it’s the fourth time in a row we’re asking for user fees, and everyone believes it’s not likely. So what is the amount of money you need in order to carry out what we asked you to carry out on FSMA – from whatever source. If we do not have the funds … what are the consequences of that?”
From the session, Hamburg was tasked to submit an outline to the committee the specifics of what FDA needs and what it will be used for.
My observation of this is that if even Representative DeLauro is not feeling positive about user fees, it is not going to happen. FDA needs a champion in Congress to move this ahead, and right now they don’t seem to have one. They also need industry aligned on this and that has not happened either, so user fees are not likely any time soon.
Reportable Food Consumer Posting
FSMA’s new provisions for the Reportable Food Registry (RFR) allow FDA to require a responsible party to submit to the Agency, for posting on its site, consumer-oriented information regarding a reportable food, including that which enables consumers to determine if they have the food. Additionally, grocery stores with 15 or more physical locations, that sold the reportable food, would be required to prominently display the information within 24 hours of, and for 14 days following, FDA’s web posting.
As such, FDA published an advance notice of proposed rulemaking (ANPRM) seeking input on:
- What information should be required on the notification and what format should it be in?
- What retail establishments should be considered “grocery stores” subject to the requirements, and how should they be made aware when information is published?
- What is “prominent display or sharing” and what impact might this have on grocery stores?
- Should consumers should be notified that this does not apply to dietary supplements, infant formula, and raw fruits and vegetables?
- Should FDA require industry to submit the information to FDA if a food will not be sold at retail to consumers?
While this has a retail focus, the registered firms need to pay attention and provide comment. This will impact them especially the last point above about information being submitted to FDA for food that will not be sold at retail.
Prior Notice of Imported Foods FAQs
FDA also published draft “Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3), “ addressing questions received since the 2004 publication of the second edition and including information related to the FSMA. In addition to information already required, a prior notice must report the name of any country to which the food has been refused entry. The guidance document is intended to help industry comply with the rule, and is open for comment through May 29, 2014
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Can FSMA Be Implemented Without User Fees? by David Acheson is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.