FDA Public Comment Sessions: Engaging the Industry

The U.S. Food and Drug Administration (FDA) recently concluded the second of three public meetings being held to solicit public comment on two Proposed Rules released by the agency in early January.

The Proposed Rules, mandated by the Food Safety Modernization Act (FSMA), are "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (produce safety) and "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (preventive controls). Both Proposed Rules would bring about significant change in the current food safety system, shifting the paradigm from one of reaction to prevention of food-related illness outbreaks.

The first public meeting was held in Washington, D.C. from February 28-March 1, 2013; the second was held in Chicago, Illinois on March 11-12, 2013. The third public meeting will be held in Portland, Oregon on March 27-28, 2013. Key staff from FDA involved in interpreting the statute and writing the regulations was on hand to present the proposed rules, explain the thought process behind certain agency actions and respond to comments and questions.  Faegre Baker Daniels and FaegreBD Consulting representatives attended the Washington, D.C. and Chicago meetings to obtain insight on industry reaction and input to the proposed regulations.

There was significant interest in these meetings with approximately 250 people in attendance at each location. Comments were provided by interested trade associations, industry participants and consumer groups. Discussion of the produce safety rule focused on what foods and entities are covered, what quality standards will apply and what exemptions will be granted. For the preventive controls rule, FDA staff discussed which facilities will be covered by the new regulation, the registration requirements and the applicability of the rule to food produced domestically as well as imported.

Thus far, few stakeholders have submitted comments on the proposed regulations, which are due by May 16, 2013. Often, stakeholders will wait to submit comments until sufficient information has been gathered, the appropriate parties have been consulted, proper analysis of the rules and information is conducted and potential recommendations are fully vetted.