FSMA Final Rule is Published but Questions Remain

Published: December 29, 2015

The long awaited final Produce Safety Rule for the Food Safety Modernization Act (FSMA) was released just after the Western Produce Auctions held their annual meeting near Windsor on Nov. 13th. Raymond Yoder gave a good presentation about the need of this final rule and the benefits it might bring, but he certainly would have preferred it finished prior to that. Thus he couldn’t go into any specifics. However, Raymond reiterated that produce auctions had received an exemption from Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Controls for Human Food regulation as a food facility. A food facility is generally processing produce in some way, which an auction is not, and complying with these regulations would be very complicated and difficult. Thus how the produce auction facilities are to be regulated or defined should be in the Produce Safety Rule.

Unfortunately, we are still waiting for some critical clarifications about the final rule from the Food and Drug Administration (FDA). These clarifications are more about the specifics of its enforcement. Much of what will be required of the growers to ‘do’, has been resolved. The purpose of this article is to inform you about what the different universities will be doing to assist, and when we’ll be providing more complete information.

The FSMA is requiring more rigorous training. The lead institution for this is Cornell University (NY) and there is now a 3 party structure for communicating on this subject, called the Produce Safety Alliance (Cornell Univ., the FDA and USDA) which has a dedicated website http://producesafetyalliance.cornell.edu/ . Beginning this year, regional training will occur around the country for educators, who will later provide training to growers. For this region that training is scheduled for Feb. 9-10th, in Joplin. It is most probable that grower trainings will NOT occur until after the 2016 growing season. Future grower trainings will be conducted by a PSA (Produce Safety Alliance) lead trainer and assisted by a PSA trainer. The Joplin training will get educators, such as the article co-authors, approved as PSA trainers.

 In November of 2014 this newsletter addressed the proposed FSMA law, and a FDA fact sheet and Q&A piece was inserted. Most of those revisions did carry through to the final rule. What there is some uncertainty on is whether growers will actually have to be inspected (like with GAPs certification) or if they’ll just have to take a training and then keep suitable records to show they are complying. Also undetermined is whether produce auction facilities are specifically mentioned, or if a generic description is used for a facility typical of this type. And then how these facilities would ‘comply’ with the rule.

We expect these questions to be resolved within a month or two. At that time we’ll send out a special newsletter edition dedicated to the final Produce Safety Rule and what appears to be most relevant to growers selling to produce auctions.

* Londa serves as State Extension Food Safety Specialist for both University of Missouri and Kansas State University. She is based in Kansas City and can be reached at tel: 816-482-5860 and email: nwadikel@missouri.edu or tel: 913-307-7391 and email: lnwadike@ksu.edu