Report compiles industry feedback to the 2011 produce rule

At the end of November, the Government Accountability Office released a report outlining the response from businesses to FDA’s 2011 produce rule, which is part of the Food Safety Modernization Act.

“Our work shows that FDA is making an effort on a number of fronts to gather input from stakeholders and is considering business concerns as it works to implement the rule,” said Steve Morris, director of the Food Safety and Agriculture Natural Resources and Environment Team.

This report highlights the steps FDA has taken to date to evaluate and respond to concerns farms, produce processors and other businesses have about the produce rule, Morris said. The report examined questions submitted by businesses to FDA’s Technical Assistance Network (TAN) from September 10, 2015 (when TAN first began operating) through March 31 of this year.

Takeaways from the review of the TAN:

• Most questions pertained to agricultural water standards under the produce rule
• Other questions covered a variety of topics, but more common topics were questions on whether or not a particular produce commodity is subject to the produce rule and questions on whether a business is subject to the produce rule or to a related Food Safety Modernization Act rule, the preventive controls rule
• 88 percent of questions requested additional information or clarification about implementing the produce rule. Five percent of questions voiced concerns about or suggested revisions to the produce rule.

To help develop the report, the GAO also examined documentation from a produce industry meeting with the FDA regarding agricultural water standards under the produce rule. The concerns expressed by industry representatives included:

• Costs associated with the new water testing requirements
• The water testing method described in the standards has not traditionally been used by industry and finding laboratories that use this method may be difficult
• The standards allow for the use of alternative testing methods, but some businesses have expressed concerns that FDA has not specified these alternative testing methods, thereby leaving businesses uncertain about what methods will be acceptable to FDA.

Morris said due to the congressionally-mandated publication date of the report, the agency could only begin to develop findings on some of the concerns outlined in the report. One of the major responses from FDA to business concerns about the produce rule has been the agency’s September 2017 proposal to extend compliance dates for agricultural water standards under the rule by two years from the original compliance dates. FDA has stated that it would use the extended compliance period to work with businesses to respond to concerns about the water standards.

In addition, FDA has been actively responding to questions received by the TAN. The report includes data showing that, as of June 2017, the agency had responded to about 84 percent of all questions the TAN had received regarding the produce rule. However, Morris said, the report notes that some produce industry representatives interviewed said that responses were often slow to arrive and some responses didn’t adequately address questions.