WASHINGTON, D.C. – Today, U.S. Senators Roy Blunt (Mo.) and Jeanne Shaheen (N.H.), and U.S. Representatives Joe Courtney (Conn.), Chris Gibson (N.Y.) and Annie Kuster (N.H.) led a bipartisan, bicameral group of lawmakers in requesting that the Food and Drug Administration (FDA) issue a second draft of regulations for public comment before issuing final Food Safety Modernization rules. In a letter co-signed by 75 members of Congress, including 42 Republicans and 33 Democrats or Independents, the bipartisan coalition expressed concerns about the impact of proposed rules on farmers and businesses that an additional comment period could help alleviate.

“Despite your agency’s efforts to engage with stakeholders during the rulemaking process, we remain concerned about the ambiguity surrounding many aspects of these proposed rules,” the letter said.

The lawmakers continued, “We believe the rules as currently proposed would result in a multitude of unintended consequences that would be severely detrimental to national, regional and local agriculture.  By seeking additional input through second proposed rules for public comment before final rules, we believe that producers’ concerns can be addressed and unintended consequences can be greatly mitigated.”

The FDA recently issued two proposed rules implementing the Food Safety Modernization Act (FSMA), a 2011 law that overhauled food safety laws to increase the safety of our food supply. The rules address preventative controls for human food and standards for the growing, harvesting, packing, and holding of produce for human consumption.  As proposed, the 1,200-page rules have left food producers and processors across the country concerned about a number of issues surrounding facility compliance, environmental standards, among others.

To read the entire letter, please see below or click here.

November 22, 2013

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

Dear Commissioner Hamburg:

We appreciate the Food and Drug Administration’s (FDA) efforts to implement the Food Safety Modernization Act (FSMA) and the agency’s willingness to seek input and guidance from producers and processors, which is of great value to our constituents.  We are confident that the rulemaking process for the proposed Produce Safety Rule and the Preventive Controls Rule (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921) will bolster the overall process of the law’s implementation.

Despite your agency’s efforts to engage with stakeholders during the rulemaking process, we remain concerned about the ambiguity surrounding many aspects of these proposed rules.  In order to improve the law’s implementation, we are writing to request that the FDA propose and submit second proposed rules for public comment before issuing the final rules.

After hearing many reservations from our farmers and businesses, we are concerned that the rules as currently proposed, and the heavy cost of complying with them, will force some producers and processors to shutter their operations.  Food producers and processors in our states are concerned with a number of issues, including:

  • The testing frequency required for certain agricultural waters;
  • Restrictions placed on the usage of biological soil amendments;
  • Compliance issues at mixed-use facilities;
  • New requirements that conflict with existing conservation and environmental standards and practices of the U.S. Department of Agriculture;
  • The limiting definitions used in the rule for “farm,” “small business” and “very small business”; and
  • The lack of consideration of the complexity of various farm ownership entities. 

We believe the rules as currently proposed would result in a multitude of unintended consequences that would be severely detrimental to national, regional and local agriculture.  By seeking additional input through second proposed rules for public comment before final rules, we believe that producers’ concerns can be addressed and unintended consequences can be greatly mitigated.

We appreciate your consideration of this request and look forward to your response.