Editor’s note: This is part of a series of articles leading up to the 20th annual Food Safety Summit. The event, from May 7-10 at the Donald Stephens Convention Center in suburban Chicago, includes certification courses; a trade show with exhibitors from industry, academia and government; an extensive list of seminars and panel discussions; and a Town Hall meeting with top officials from the FDA, USDA and CDC. Visit www.foodsafetysummit.com to register.


As FDA and state agencies begin their outreach and inspection efforts relative to the new FSMA requirements, a number of operational concerns have arisen which have caused concern for regulators and confusion for the regulated industries.

In particular, food companies where multi-agency jurisdiction and authority exist, there is uncertainty as to what rules applies, what guidance should be followed, and where agency jurisdiction ends. Food companies may need to adhere to different and conflicting rules and guidance for the differing products produced there. This situation has created an almost dysfunctional regulatory situation for some operators. 

It’s somewhat of a conundrum for industry to understand who regulates, what they regulate, how they regulate, and when they regulate.

Throw in state regulations and authorities, and the recent Department of Justice interpretation that guidance documents are not enforceable, and it is easy to see the complexity of the situation. 

The Association of Food & Drug Officials (AFDO) has assembled a dynamic panel to address these concerns on at the day before the 20th Anniversary Food Safety Summit. Set for 2:45 p.m. on May 9, the session “FSMA Matters – Addressing Multi-Agency Jurisdiction and Rules” includes a panel discussion with:

  • Bob Hibbert, attorney at Morgan Lewis;
  • Charles Cook, managing partner, Country Fare Consulting LLC;
  • Lowell Randel, vice president for Regulatory Affairs for the Global Cold Chain Alliance (GCCA); and
  • Tracie Sheehan, chief health, quality and sustainability officer at ARYZTA

These regulatory experts will be asked to identify and discuss those regulatory situations that cause confusion for food plant operations and to offer suggestions on how these matters could be resolved.

In addition to this course, the Summit will offer a Regulatory Community Group as part of the Supply Chain Discussion Groups on Wednesday morning. Join Joann Givens of FDA; Steve Moris of the Kansas Department of Agriculture, and Ben Miller of the Minnesota Department of Agriculture. 

During this interactive session these leading regulators will focus on FSMA and how FDA is working with its partners from the states who are playing a key role in inspections.

Food Safety Summit attendees will have the change to meet one-on-one with these and other subject matter experts in the Regulatory Community Café on the trade show floor. Visit www.foodsafetysummit.com for the complete schedule.

About the author: Joseph Corby worked for the New York State Department of Agriculture and Markets for 37 years retiring in 2008 as the Director of the Division of Food Safety and Inspection. He is currently the Executive Director of the Association of Food & Drug Officials (AFDO), and he serves on the Board of Directors for the International Food Protection Training Institute (IFPTI) and the Partnership for Food Safety Education (PFSE). He has been an outspoken advocate for the advancement of a nationally integrated food safety system and continues to work with numerous groups and associations in support of this cause.

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Joseph Corby worked for the New York State Department of Agriculture and Markets for 37 years retiring in 2008 as the Director of the Division of Food Safety and Inspection. He is currently the Executive Director of the Association of Food & Drug Officials (AFDO), and he serves on the Board of Directors for the International Food Protection Training Institute (IFPTI) and the Partnership for Food Safety Education (PFSE). He has been an outspoken advocate for the advancement of a nationally integrated food safety system and continues to work with numerous groups and associations in support of this cause.