Letter to Margaret Hamburg, FDA Commissioner - Food Safety Modernization Act (FSMA)

Letter

August 13, 2013

The Honorable Margaret Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Re: Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921

Dear Commissioner Hamburg:

Thank you for providing our staff with a briefing on the Food and Drug Administration (FDA)'s proposed Food Safety Modernization Act (FSMA) rules for produce safety and for preventive controls for human food. We appreciate your outreach efforts on this issue and your willingness to hold public meetings in New England so that our constituents and agricultural producers have the opportunity to engage with the FDA regarding these proposals. We also appreciate the additional 60-day extension to the comment period recently granted by your agency.

We are very concerned about the ability of smaller farms to comply with these rules as currently proposed, as well as the negative effects of compliance on local food networks and consumers in New England. As a result, we are writing to request additional information and clarification, which we view as essential in order for our constituents to sufficiently review, understand, and comment as requested. To help in this process, please provide response and explanation for the following questions:

1) Congress included a number of provisions to make sure that FSMA requirements did not undermine conservation practices and environmental laws supported by other agencies and did not conflict with National Organic Program regulations. As such, any rulemaking pursuant to implementation of FSMA must be done in the context of regulatory activity from other agencies. How do the FDA's proposed rules relate to existing conservation and environmental standards and practices of the U.S. Department of Agriculture? How is FDA planning to reconcile the differences with the regulations established for the National Organic Program?

2) While FSMA requires the FDA to establish science-based standards for safe food production, it appears that the agency lacks sufficient data to support many of its proposed requirements. Furthermore, while the FDA has thus far been unable to explain the scientific rationale for many of its requirements, it expects producers to have such data should they seek alternative means of compliance. How is FDA planning to secure adequate data to inform the development of these regulations? How is FDA planning to provide training, technical assistance, and guidance to producers and processors who will have to comply with the regulations? If an alternative measure is used, who is liable should an outbreak occur?

3) Who will be responsible for inspections and oversight of the requirements established under both proposed rules? How will FDA ensure that the financial burden of FSMA implementation does not end up with the states?

4) We have heard many concerns regarding proposed regulations for agricultural water use within the produce safety rule pertaining to the cost of compliance, laboratory capacity issues, testing for multi-source irrigation, and lack of approved water treatment methods. Please refer to the attached document and provide a response for the questions and scenarios outlined therein.

Further clarification on these matters will begin to help provide our agricultural producers with a better understanding of the proposed rules as they prepare comments for submission.

We all believe that America should have a system of food safety protections that is second to none. We appreciate the opportunity to work with you in ensuring that FDA promulgates rules that recognize the diversity of agricultural producers and the needs of consumers across America.

Sincerely,

Jeanne Shaheen Ann McLane Kuster
United States Senator Member of Congress

Angus S. King, Jr. Chellie Pingree
United States Senator Member of Congress

Kelly A. Ayotte Michael H. Michaud
United States Senator Member of Congress

Susan M. Collins Jim Langevin
United States Senator Member of Congress

Carol Shea-Porter
Member of Congress

William R. Keating
Member of Congress

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