December 19, 2013
FDA appreciates and takes very seriously the extensive input we have received from produce farmers and others in the agricultural sector on the proposed FDA Food Safety Modernization Act (FSMA) rules on produce safety and preventive controls for human food, which we published in January 2013. We have made every effort to solicit input on the proposed rules, not only through the standard rulemaking process, but also by participating in more than 150 meetings and by travelling to numerous farms of varying types and sizes from Maine to California. To ensure broad input and facilitate constructive dialogue with the produce community, FDA has extended the comment periods on the proposed rules three times.
Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement.
To achieve this goal, we believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.
Because the changes to the key provisions would be significant, FDA plans to propose revised rule language and seek comment on it, allowing the public the opportunity to provide input on our new thinking. There may be other revisions to the proposed rules; the scope of the revised proposals, on which we will seek further comment, will be determined after we complete our initial review of written comments. We believe that this additional step to seek further input on revised sections of the proposed rules that need significant adjustment is critical to fulfilling our continuing commitment to getting these rules right.
Our plan is to publish revised proposed rule language by early summer 2014. We will accept additional comments only on those sections of the proposed rules that have been revised. FDA remains under a court order regarding the timelines for finalizing these rules. FDA recognizes that completing these rules is essential to protecting the public health and is committed to completing them as quickly as possible.
It is gratifying to FDA that in our meetings around the country, we have received broad support for moving forward in implementing FSMA in a timely manner in light of its important food safety and public confidence goals. Thanks to all of you who have worked with us. We will continue this collaborative approach as we move down the pathway to final rules and to full implementation of the FDA Food Safety Modernization Act in the years to come.
See also, Your Input is Bringing Change to Food Safety Rules, a blog by Michael Taylor.