RT12 The Devil is in the Details:  Experiences with Early Implementation of the FSMA Produce Safety Rule and Efforts to Fill the Information Gaps

Wednesday, July 12, 2017: 10:30 AM-12:00 PM
Room 13-14 (Tampa Convention Center)
Primary Contact: Michelle Smith
Organizer: Michelle Smith
Convenors: Bassam Annous and Michelle Smith
Panelists: Michelle D. Danyluk , Bob Ehart , Jennifer McEntire , James Rushing , Don Stoeckel and Trevor Suslow
FDA's Produce Safety Rule creates, for the first time, federal requirements for the on-farm production and handling of produce (new 21 CFR Part 112). The compliance dates for the largest farms will be January, 2018. FDA estimates that over 37,000 U.S. and foreign farms exporting produce to the U.S. will be covered by the rule.  More farms may be impacted, either through voluntary adoption or through buyer requirements. 

In some places, rule requirements are very specific. In other places, FDA focused on the basic objectives or “end points” rather than being prescriptive about what approach needs to be used.  This flexibility recognizes the diversity of practices and conditions related to produce production. In some cases, the science is still evolving. However, even where the basic scientific principles are well established, there may not be sufficiently specific data to provide practical guidance about how to comply or how practices might be implemented on very diverse operations. Identifying and filing information, education, outreach, guidance, and research needs to facilitate compliance with this new regulation will be a massive effort involving a host of regulatory and technical assistance and training groups, many of them newly created for this purpose. 

Roundtable panelists will share their experience in early implementation, such as impressions from the cooperative FDA/NASDA on-farm readiness reviews; questions raised through technical assistance networks (TANs), national and regional centers, and at alliance trainings. This roundtable will begin a conversation about (i) the current state of on-farm readiness; (ii) challenges to implementation, including understanding of FDA's expectations for compliance with rule requirements and access to sufficient tools and technical resources for implementation; and (iii) how the groups represented by the panel might work, independently and in collaboration, to assist farms in implementing and achieving science-based and measurable food safety objectives.

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