District and State Recall Cooperative Plan Chairs: Brad Honold, MDA Innovation Grants Project Manager Wanda Lenger, FDA ORA/OEIO/DE Recalls March 12 th, :45-3:15 p.m.

Sponsorship/Partnership Partnership for Food Protection (PFP) Response and Recall Workgroup PFP Work Groups develop projects to advance the implementation of an Integrated Food Safety System (IFSS) - This is an FDA FSMA mandate to create an IFSS. Project approved by the PFP Governing Council

District and State Recall Cooperative Plan Objective: Establish a “Best Practices” document(s) for outbreaks and class 1 recall situations for use by FDA and State Counterparts that will enhance reciprocal communication and sharing of recall information with the intention of reducing the burden on recall staff.

State/FDA Recall Survey 2013 Goals: Identify Recall Contacts Identify Barriers to Communications Identify What Currently Works

Summary of Survey Results 59 Respondents w/70 Comments: Sharing and Timeliness - 26 Format of Information - 10 IT Recommendations - 10 Audits / Effectiveness Checks - 9 Federal Regulations - 7 Contacts and Methods - 6 RFR Comments - 2

Our Project Team – 53 Members*! PFP Workgroup members FDA Subject Matter Experts State Public Health Officials *These are individuals who expressed an interest in enhancing recall effectiveness, implementing an integrated food safety system, and assisting in improving transparency of communication during recalls. The team will be listed in the Best Practices document upon completion.

Creating Our Best Practices Document: Examine the current recall process for improvements Examine the RFR report distribution process Examine regulatory restrictions that slow the sharing process Define common terms, and acronyms

Creating Our Best Practices Document cont. Establish and post a directory of recall contacts Review IT systems for avenues to enhance automatic notifications Examine, identify, and recommend parameters for information sharing (Commissioning/20.88 agreements)

Areas/Ideas Being Explored Contact List for Recall personnel – Identify contacts – Create and maintain contact lists – Posting of contact list

Areas/Ideas Being Explored cont. Barriers in Sharing – Identify Regulations – Define/Explain the Regulatory Barriers – Enhance Sharing Process

Identify Potential Mechanisms for Sharing Reportable Food Registry (RFR) Food Track Social Media RSS Feeds for Press Releases FoodSHIELD Explore availability of automatic notifications

Identify Potential Mechanisms for Sharing cont. Initial Notifications Minimum information Format Identify Staff Contacts Periodic Meetings

Recall Effectiveness Checks Assignment, Tracking, and Monitoring of Effectiveness Checks Recall Audit Check (RAC) – electronic assignments through eSAF (electronic State Access to FACTS) Training Minimize overlap of investigations by FDA and State

Notifications during dual jurisdiction recall events Who to contact When to contact How to contact Methods to minimize duplication of efforts

Outstanding Project Needs We could particularly use some higher level individuals with state recall expertise (non-working member – more advisory role) We do have some gaps in state representation, with a particular gap in our sub-workgroup assigned with the Best Practices document assembly. If anyone is interested, please contact Brad or Wanda

Next Steps Continue collaborative meetings with committees Plan, Prepare, and execute PFP Face-to-Face meeting late April 2014 Present Final Draft document at 50-State meeting in August 2014

Summary In order to enhance our joint mission to protect public health, we are exploring methods to establish a uniform “Best Practices” document to enhance reciprocal communication and sharing of recall information during outbreaks and class I recalls with the intention of reducing the burden on recall staff.

Thanks for letting us present a project update!

Contact Information Brad Honold Innovation Grants Project Manager Minnesota Department of Agriculture

Contact Information Wanda Lenger ORA/OEIO/DE Recalls FDA

Data Sharing Best Practices Work Group – Time permitting… Created out of a vision shared between MDA and GDA Meeting since July 2013 Collaborative FDA and State endeavor Discuss and demo process and systems development efforts ultimately with the goal of improved Recall and Traceback investigative efforts Liaising with the PFP IT Workgroup (Two members are on this WG – Don Jaccard & Daniel Pennell)

Data Sharing Best Practices Work Group – Desired Outputs Agreement and understanding on Key Data Elements (KDEs) to share despite different IT systems Develop Best Practices to support IFSS Better data sharing between regulatory entities Improved reporting to FDA during/after investigations

Data Sharing Best Practices Work Group – State Partners/Systems Pennsylvania (USA FoodSAFETY) Iowa (USA FoodSAFETY - CAI) North Carolina (In-house developed system) Georgia (DHD – Garrison Enterprises) Minnesota (Sharepoint to USA FoodSAFETY) Michigan (MI-Inspector to an Accela platform) Kansas (WinWam and a number of other systems) New York (In-house Access database as a LIMS)

Data Sharing Best Practices Work Group – FDA Partners/Acronym Quiz! OP OIM Audits ORA/OO/IO PFP IT Workgroup* (See last slide for recently approved Information Technology Data Principles - with a link) Demos or presentations included: eSAF RAC, Palantir (CDC), new 3177 Form (keeping these fields in mind during KDE discussions)

Further Data Element Analysis Being Pursued for Critical Tracking Events Common Field Names Palantir Data Distribution Data Key Data Elements – GS1 FDA’s Form 3177 MN Investigation Event MI/CORE Traceback Questions Definitions

*PFP IT Workgroup Information Technology Data Principles (Summer 2013) – Approved by Governing Council December 2013 Link to the document: oodSafetySystem/ucm htm oodSafetySystem/ucm htm If there are any questions regarding this document, please contact Don Jaccard, FDA: