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FDA Talks to Congress about FSMA Implementation

February 7, 2014


This week, two events took place on the Hill focused on the ongoing implementation process of the Food Safety Modernization Act (FSMA).  Mike Taylor, the Food and Drug Administration’s (FDA) Deputy Commissioner for Foods and Veterinary Medicine, who is leading the implementation of FSMA, served as the primary FDA representative at both events.

Briefing on FSMA Implementation

Today, the Center for Science in the Public Interest hosted a briefing to discuss issues and perspectives on the requirements and timing of the proposed Produce Rule, one of the major new regulations being developed at FDA.

Taylor opened the discussion by emphasizing the recent momentum in publishing rules, with the seventh proposed rule, the Sanitary Transportation of Human and Animal Food, now open for public comment.  He also discussed the agency’s stakeholder engagement process and their federal-state partnership approach, while underscoring the importance of additional funding for proper implementation of the proposed rules.  He described this “FSMA funding gap” — the difference between the funding available and the funding needed — as totaling approximately $225 million.  He also made clear that the agency intends to meet the court-ordered deadline of June 3o, 2o15, for the completion of the rules.

After Taylor, a panel of food safety stakeholders spoke about their perspectives.  The panel included Roland McReynolds, the Executive Director of NSAC member group Carolina Farm Stewardship Association.  Also on the panel were Bob Ehart of the National Association of State Departments of Agriculture, Sandra Eskin of the Pew Charitable Trusts, and Robert Guenther of United Fresh Produce Association.

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McReynolds kicked off the panel discussion with a strong voice in support of the sustainable agriculture community and NSAC’s key priorities, focusing on the need to “get it right,” rather than just “get it done,” a sentiment later echoed by all participants.  His statements prioritized the need for a food safety regimen that both protects consumers and is fair and reasonable for farmers by supporting them in producing healthy food for local, regional, and larger markets, which is critical in achieving widespread public health goals.  He stressed specific problems with the proposed Produce and Preventative Controls Rules, including the manure and compost standards and definitions of “farm” and “facility.”

House Energy and Commerce Hearing

Yesterday, at a hearing held by the Health Subcommittee of the House Energy and Commerce Committee, Taylor responded to questions from Representatives of both parties primarily about concerns over the timeliness, scope, and funding for the implementation of the FSMA rules.  Several members indicated their strong support for the extended comment period and re-write of the Produce and Preventative Controls Rules.  Another highlight of the hearing was FDA’s recognition of the need for and commitment to training and technical assistance programs geared towards both farmers and inspectors to encourage voluntary compliance and effective regulatory oversight.

Throughout the hearing, the precise amount of funding necessary for the full and proper implementation of the FSMA regulations was a common thread, along with the potential for the food-related user fees that were included in the House version of the law, and were in the President’s FY 2014 budget, to cover the current gap in funding.  Taylor emphasized the importance of securing the fees as part of a greater appropriations request, and repeatedly reiterated the need for additional agency resources, while pledging to forge ahead as quickly as possible in the meantime towards the finalization of the rules.

Just as the FSMA authorizers ultimately rejected user fees in the 2010 FSMA legislation, congressional appropriators have also since then rejected the Administration’s request for user fees for FDA’s budget for FSMA implementation.

Food industry groups sent a letter to FDA and the White House on Tuesday voicing their objection to the imposition of user fees, which they called a food tax.  Despite these protests, it is widely expected that the President will once again propose user fees when he releases his budget proposal in early March.

During the legislative phase of FSMA, NSAC opposed a “one-size-fits-all” approach to user fees, especially to facility registration fees.  A one-size-fits-all user fee approach, where all facilities — regardless of size — must pay the same fee would disproportionately affect farms that do value-added processing or other basic activities currently under the “facility” definition.  The failure of the Administration to address this issue leaves it with very few supporters.


Categories: Food Safety, General Interest


2 Responses to “FDA Talks to Congress about FSMA Implementation”

  1. Harry Hamil says:

    Is there a link to an audio of either or both of these events?

    In particular, I would like to hear what Roland McReynolds actually said. Is there a transcript? Did he used prepared remarks?

  2. Sarah Hackney says:

    Harry, here is a link to the hearing, which was recorded: http://energycommerce.house.gov/hearing/examining-implementation-food-safety-modernization-act

    Unfortunately there is no recording of the briefing, and Roland did not work from prepared remarks.

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