District and State Recall Cooperative Plan
Chairs:
Brad Honold, MDA
Innovation Grants Project Manager
Wanda Lenger, FDA
ORA/OEIO/DE Recalls
March 12th, 2014
2:45-3:15 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:
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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
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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
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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
Brad.Honold@state.mn.us
Contact Information
Wanda Lenger
ORA/OEIO/DE Recalls
FDA
Wanda.Lenger@fda.hhs.gov
Data Sharing Best Practices Work
Group – Time permitting…
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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
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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!
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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
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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:
http://www.fda.gov/ForFederalStateandLocalOfficials/F
oodSafetySystem/ucm357502.htm
• If there are any questions regarding this document,
please contact Don Jaccard, FDA:
Donald.Jaccard@fda.hhs.gov