Barbara Cassens, Senior Advisor/Acting Director, Office of

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Current PFP Workgroups
• Implementation &
Communication
• Information Technology
• National Feed Assignment
• PETNet Expansion
• Training & Certification
• Local Engagement
• Response & Recall
1
Implementation & Communication WG
Charge
Develop an implementation plan to
facilitate the use of IFSS best
practices across federal, state,
local, tribal, & territorial
governments.
WG Co-Chair: Tracey Forfa (CVM)
WG Co-Chair: Mel Plaisier (ORA)
WG Co-Chair: Roberta Wagner
(CFSAN)
Current Projects
•
Implement Local Work Planning
Document from 50-State Workshop
•
Implement Joint Inspection framework
from 50-State Workshop
•
Implement National Standards for
Food/Feed Testing Guidance Document
•
Implement After Action Review process
•
Implement Performance Measures
projects
•
Develop a Communication Strategy for
PFP
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Implementation & Communication WG
(FDA Reps)
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Tracey Forfa (CVM)
Mel Plaisier (ORA)
Steve Solomon (ORA)
Roberta Wagner (CFSAN)
Kara Morgan (OC)
Don Burr (CFSAN)
Hitelia Castellanos (ORA)
Tara Doran (ORA)
Carie Jasperse (OCC)
Andrew Becher (OCC)
Cathy McDermott (OFVM)
Sherri McGarry (OFVM)
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Tim McGrath (ORA)
Jenny Murphy (CVM)
Eric Nelson (CVM)
Deep Patel (OC)
Sherry Purvis-Wynn (ORA)
Shannon Rutherford (CVM)
Pete Salsbury (CFSAN)
Marianna Solomotis (CFSAN)
Lawrence Sproul (ORA)
Nadine Steinberg (CVM)
Iris Valentin-Bon (OC)
3
Julianna Wittig (CVM)
Information Technology (IT) WG
Charge
Defining and understanding the
requirements for developing an
integrated electronic information
management backbone, and
undertaking technical projects to
create an interoperable and
integrated national food safety
system.
WG Co-Chair: Tiffani Onifade (FL)
WG Co-Chair: Don Jaccard (FDA)
Current Projects
•
Developing a data dictionary to
standardize terminology and
facilitate the capture & exchange
of common data elements
•
Establishing a plan to increase
the number of agencies capturing
baseline set of common data
elements for a subset of
programs/activities
4
Information Technology WG
(FDA Reps)
• Don Jaccard (OFVM)
• Barbara Cassens (ORA)
• Lauren Gore (ORA)
5
Local Engagement WG
Charge
Current Projects
To incorporate the Food Safety
•
Modernization Act (FSMA) deliverables that
include “local” agencies with PFP projects &
provide specific recommendations for
engagement of local agencies within the
•
vision for an IFSS.
WG Co-Chair: Pat Maloney (MA)
WG Co-Chair: Liz O’Malley (FDA)
WG Co-Chair: Davene Sarrocco-Smith (OH)
Members to review the Food
Safety Modernization Act
(FSMA) & how it applies to
working with local agencies.
Review FSMA provisions and
PFP projects to determine
where local engagement is
appropriate and best way to
engage.
6
Local Engagement WG
(FDA Reps)
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Jeff Farrar (OFVM)
Laurie Farmer (ORA)
Lauren Gore (ORA)
Liz O’Malley (ORA)
Pete Salsbury (CFSAN)
7
Response & Recall WG
Charge
Develop response guides and records
for event responses.
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WG Co-Chair: Travis Goodman (FDA)
WG Co-Chair: Ben Miller (MN)
Drafted an Index of investigation,
response & recovery guidance
documents
Drafted a Guide for States on
Records Collection for More
Successful Tracebacks
Completed White paper on
traceback investigations
Drafted a PFP Quick Start
Response Guide
Current Projects
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Complete the items above
Identify 2-3 new Response &
Recall Projects
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Response & Recall WG
(FDA Reps)
• Jeff Farrar (OFVM)
• Travis Goodman (ORA)
• Roberta Hammond
(CORE)
• Pamela LeBlanc (CORE)
• Wanda Lenger (ORA)
• Priscilla Neves (ORA)
• Mahala Shillingford
(OFVM)
• Cecilia Wolyniak (ORA)
• Lauren Yeung (ORA)
9
National Feed Assignment WG
Charge
Current Projects
Develop methods of sharing feed
collection samples between
federal & state agencies.
•
Domestic Import Sampling
Assignment
•
Develop a database for sharing
information relative to feed
samples
•
Complete White Paper on Retail
Food Salvage for Animal Feed
WG Co-Chair: Dan Danielson (TN)
WG Co-Chair: Darlene Krieger (FDA)
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National Feed Assignment WG
(FDA Reps)
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Mary Bartholomew (CVM)
Darlene Krieger (ORA)
Sherri McGarry (OFVM)
Kara Morgan (OC)
Jenny Murphy (CVM)
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Eric Nelson (CVM)
Deep Patel (OC)
Iris Valentin-Bon (ORA)
Julianna Wittig (CVM)
11
PETNet Expansion WG
Charge
Current Project
Provide mechanism for information
sharing and monitoring between
federal & state agencies for pet-food
related incidents so that
these agencies can determine
quickly best response & action.
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Review current Pet Event Tracking
Network (PETNet) system for
improvement needs.
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Expand PETNet system to include
food producing animals:
– Develop appropriate questions
for reporting livestock feed
concerns
– Develop the livestock portal
– Determine how/if the livestock
and PETNet portals will interact
WG Co-Chair: Liz Higgins (NM)
WG Co-Chair: Jenny Murphy (FDA)
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PETNet Expansion WG
(FDA Reps)
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Krisztina Atkinson (CVM)
Jean Bowman (CVM)
Alberto Chiesa (CVM)
Zoe Gill (CVM)
April Hodges (CVM)
Caleb Michaud (ORA)
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Jenny Murphy (CVM)
Jackie Queen (CVM)
Marianne Ross (CVM)
Renee Shibukawa-Kent
(CVM)
• Lauren Yeung (CVM)
13
Training & Certification WG
Charge
Current Projects
To provide support for visionary
development, best practices,
appropriate content and
recommendations toward
development of an integrated food
safety training & certification system.
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Linking FSMA Sections to the
IFPTI Curriculum Framework
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Develop a process that would
identify and prioritize training and
certification needs
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Develop a process to identify
and qualify existing analyses,
bodies of knowledge, or other
underlying frameworks for job
related curriculum that fit the
IFSS curriculum framework.
WG Co-Chair: Allan Bateson (FDA)
WG Co-Chair: Steve James (FDA)
WG Co-Chair: Keith Johnson (ND)
WG Co-Chair: Dave Read (MN)
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Training & Certification WG
(FDA Reps)
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Allan Bateson (ORA)
Atin Datta (CFSAN)
Jim Fear (ORA)
Steve James (ORA)
Karyn Johnstone (CVM)
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Thomas Hughes (ORA)
Cindy Leonard (ORA)
Kara Lynch (ORA)
John Marcello (ORA)
Pete Salsbury (CFSAN)
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Take Home Messages
• The PFP plays a collaborative role in building an IFSS.
• We need to identify the most significant IFSS gaps and “fund the
gaps”.
• PFP & FSMA have the same goal; to build an IFSS.
• FSMA work has been aligned/merged with the dynamic PFP
Workgroups.
• Integration will not happen overnight, but working in partnership,
we are making strides towards having an IFSS become a reality.
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Relevant PFP Accomplishments &
Outputs from Related Efforts to
Support the Building an IFSS
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FDA/ORA/Office of Partnerships
Central hub for:
• Information sharing
• Communication with
partnering agencies & trade
organizations
• Execution of partnerships,
grants, & cooperative
agreements
• Links to public documents &
information
• Program Summaries
• Contact Information
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Utilization of State Programs as Partners
FY12 Inspection Contract Programs
Program
# of Awards
Food*
46
Feed
35
Egg
8
Tissue Residue
21
MQSA**
44
Medical Device
1
Milk Residue
1
Totals
$15M
*43 states, 1 territory
**Mammography Quality Standards Act
***Analysis of nearly 4 million milk residue samples
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Expanding Support Opportunities
FY12 Grants & Cooperative Agreements
Programs
# of Awards
Food Protection Task Forces
23
Food Emergency Response Network (FERN)
34
Ruminant Feed Ban Support (BSE)
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Rapid Response Teams
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Innovative Food Defense
3
Small Conference Grants
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FSMA Emergency Response & Risk Based Inspections
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Manufactured Food Regulatory Program Standards
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ISO 17025:2005 Laboratory Accreditation
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Voluntary Nat’l Retail Food Regulatory Program Standards
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Integrated Laboratory System
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Alliances
2
Total Funding
$44.3M
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National Program Standards:
Manufactured Food Regulatory Program Standards
(MFRPS)
• Uniform foundation for the design and
management of state programs
responsible for regulating food
manufacturers.
• Institute a comprehensive quality
assurance & standardization program.
• FDA conducts Program Assessment
Validation Audits (PAVAs) at 18 and 36
months; & comprehensive audit at 60
months.
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Building a Stronger MFRPS Community
• 41 programs in 40 States
– Increased from 28
programs in 2010 to 41
programs in 2013
• FoodSHIELD: Workgroup &
Quarterly Webinar
• MFRP Alliance
– 1st Annual MFRPS Training Course conducted March, 2012,
– 2nd Annual MFRPS Training conducted March 19-21, 2013.
– Strengthen: Community, Collaboration, Resources, & Program
Advancement.
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National Program Standards:
Voluntary National Retail Foods Regulatory Program
Standards (VNRFRPS)
• Standards provide:
– A guide to design and management of a retail food
program.
– A program foundation.
– A tool to evaluate the effectiveness of food safety
interventions.
• 553 regulatory jurisdictions enrolled (as of April 2013)
• Additional information available at
http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/Pr
ogramStandards/default.htm.
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Rapid Response Teams (RRT)
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Multi-year Cooperative Agreement
– Awards range from $300,000 - $500,000
– Awards typically 3 years in length
– 9 began in 2008/2009
– 10 added in 2012
Why RRTs?
– White House & Congressional
interest in improving response
and food safety.
Purpose:
*
Did You Know
9 RRTs are in Public
Health Agencies
10 RRTs are in
Departments of Agriculture
– Improve response by unifying & coordinating partners
– Develop effective models for response that can be replicated.
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Rapid Response Teams (Original & Additions from 2012 RFA)
NWE-DO
DET-DO
MIN-DO
NYK-DO
PHI-DO
NER
SEA-DO
BLT-DO
CER
ATL-DO
SAN-DO
NOL-DO
FLA-DO
LOS-DO
KAN-DO
SER
Rapid Response Teams (RRTs)
Original RRTs
New RRTs
Original RRTs
Southeast Region
PAR
NC (ATL-DO)
New RRTs
Central Region
GA (ATL-DO)
MI (DET-DO)
PA (PHI-DO)
TN (NOL-DO)
N (MIN-DO)
WV (BLT-DO)
MS (NOL-DO)
VA (BLT-DO)
MD (BLT-DO)
FL (FLA-DO)
Northeast Region
SWR
Southwest Region
NY (NYK-DO)
MA (NWE-DO)
IA (KAN-DO)
TX (DAL-DO)
RI (NWE-DO)
Pacific Region
DAL-DO
= RRT State (Original- Joined 2008/2009)
= New RRT State (Under 2012 RFA)
WA (SEA-DO)
CA (LOS-DO & SANDO)
N/A
MO (KAN-DO)
Summary:
Total: 19 States/14 Districts
•2008: 6 States/7 Districts
•2009: 3 States/3 Districts
•2012: 10 States/7 Districts
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Bringing Together the Regulatory Community
• Operationalizing mutual needs to make the
regulatory community “Partners” programs
stronger and more efficient with minimal
duplication of efforts.
• Utilization of the Joint Work Planning
document from the PFP work group.
• Developing mechanisms to engage other
stakeholders in the process by:
– Bringing their ideas to the table for
future work;
– Inclusion of overall continuous
improvement toward a fully integrated
food safety system.
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Accomplishments of 2010-2012 PFP WGs
• Compliance/enforcement coordination pilot.
• Developed local work planning process to reduce redundant
inspections/leverage resources.
• Developed Business Process Evaluation Tool to evaluate IT
gaps/needs relative to Inspection Systems.
• Developed the “National Standards for Food/Feed Testing
Laboratories”.
• Developed recommendation for a process to review/update
MFRPS.
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Thank You for Your Attention
We Welcome Your Questions,
Comments & Suggestions
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