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GAO Reports on FSMA Implementation; Plans Needed for Evaluating Impacts on Farmers

November 30, 2016


Yellow squash on a processing trailer, at Kirby Farms in Mechanicsville, VA. Photo credit: USDA.

Squash on a processing trailer, at Kirby Farms in Mechanicsville, VA. Photo credit: USDA.

With the new Food Safety Modernization Act (FSMA) regulations now finalized by the Food and Drug Administration (FDA), the process of implementation is underway.  As part of the implementation process, FDA has the responsibility to field and respond to concerns from farmers and food businesses, and to evaluate the impact of the rules on farmers and food businesses, making any changes to the way the rules are implemented as necessary.

In order to ensure this process works well, Congress included language in the 2014 Farm Bill directing FDA to establish a plan for effectively taking input and responding efficiently to concerns and questions raised. The U.S. Government Accountability Office (GAO) was assigned to report on FDA’s progress.

This provision of the Farm Bill, championed by Representative Dan Benishek (R-MI), calls for FDA to do the following, specifically within the context of the Produce Safety Rule:

  1. An analysis of the scientific information used to promulgate the final rule, taking into consideration any information about farming and ranching operations of a variety of sizes, with regional differences, and that have a diversity of production practices and methods;
  2. An analysis of the economic impact of the final rule; and
  3. A plan to systematically:
    1. Evaluate the impact of the final rule on farming and ranching operations; and
    2. Develop an ongoing process to evaluate and respond to business concerns.

This week, the GAO issued a brief report on FDA’s efforts to date. The report looks only at part 3b: the ongoing process for evaluating and responding to business concerns, as embodied in FDA’s Technical Assistance Network, or TAN.

TAN is a platform through which anyone can ask a question to FDA about the FSMA rules. FDA then responds directly to the questioner. FDA uses the information received through TAN to determine whether or not an issue is a high-priority (based on how many times the issue or similar issues are raised), and/or one for which additional guidance is necessary. FDA also soon plans to survey users of TAN and ask them for feedback on the platform and quality of the responses. They will use the results of this survey to determine what kinds of changes to the system are needed.

It is not yet clear when FDA will carry out the remainder of the 2014 Farm Bill mandate regarding Produce Rule implementation. It is an important and significant task to systematically evaluate the impacts of the final rule on farmers and to evaluate the rule based upon potential changes in scientific data and information, including any variability based on regional differences or production practices.

The National Sustainable Agriculture Coalition (NSAC) has long advocated that such plans be developed with public input. An effective system would allow for continuous improvement of the rules, the way they are implemented, and the food safety practices that farmers are following. We strongly encourage FDA to move forward with implementation of the remaining provisions of the Benishek provision in partnership with key stakeholders from the farming community, and we encourage Congress to take steps to ensure FDA is adequately funded to take on this task.


Categories: Food Safety


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