Adding legislative clout to widespread industry sentiment, 75 members of Congress have asked the Food and Drug Administration to issue a second draft and comment period for proposed food safety rules.

The Nov. 22 letter, signed by Democrats and Republicans of both chambers, asks FDA Commissioner Margaret Hamburg to “submit second proposed rules for public comment before issuing the final rules.”

“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,” according to the letter.

In particular, lawmakers said they have been hearing objections from growers and businesses about the cost of the produce safety regulation and the preventive controls regulation for food facilities. The comment period for proposed regulations on both rules ended in November.

“We are concerned that the rules, as currently proposed ... will force some producers and processors to shutter their operations,” the lawmakers said.

Growers and processors are most concerned about six issues, according to the letter:


  • Testing frequency for agricultural water;
  • Restrictions placed on biological soil amendments;
  • Compliance issues at mixed-use facilities;
  • Requirements conflicting with existing conservation and environmental standards and practices of the U.S. Department of Agriculture;
  • 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.


Ray Gilmer, vice president for issues management and communication for the Washington, D.C.-based United Fresh Produce Association, said the letter underscores the conviction of many in the fresh produce industry that more time is needed to consider how the FDA’s approach to food safety regulations.

An FDA public affairs officials said in an e-mail that the agency would "carefully consider"  all concerns raised to get the final rule right, but did not say if the FDA would issue a second set of draft rules.