1. Investments in Federal-State Programs to Support an Integrated
Food Safety System (IFSS)
Joe Reardon
Senior Advisor for Federal-State Relations
FDA/Office of Regulatory Affairs
National Association of State Departments of Agriculture
Food Regulation & Nutrition Committee Meeting
September 16, 2012
Des Moines, IA

2. A National Integrated Food Safety System (IFSS)
Jointly developed and implemented inspection and enforcement programs
Benefits:
Increased ability to assess potential risks at domestic food facilities
More consistent coverage of these facilities across the entire food supply chain
Greater food surveillance through integration of food facility inspection information
Improved rapid response capacity and efficiency
Outcome: Increased public health protection
What is Federal-State Integration?
Working with our State, local, and tribal partners to develop and implement an inspection and enforcement program to ensure high rates of compliance with the Agency’s food safety standards
It will require significant work with our State partners through work-planning and training to ensure the best utilization of resources
An integrated system will result in more coordinated response efforts to better leverage resources and to respond to multi-State outbreaks when they occur
We have funded State Rapid Response Teams to develop Rapid Response processes
Collaborating with our State partners, FDA will continue to build an Integrated Food Safety System (IFSS)
Benefits of an Integrated Food Safety System
Increased ability to assess potential risks at domestic food facilities
More consistent coverage of these facilities across the entire food supply chain
Greater food surveillance through integration of food facility inspection information
Improved rapid response capacity and efficiency

3. *
Did You Know…
For new awards issued thus far in FY12, 31 have gone to Departments of Agriculture, totaling over $7.4M.
Awards include those for ISO, MFRPS, RRT and Innovative Food Defense
We are thrilled to be here at the 2012 NASDA Annual Meeting, and to have this opportunity to present on the great work being done by DFSR, as well as to have more interactions with such dedicated and involved members of the food regulatory community.
DFSR has enjoyed a highly productive relationship with NASDA and its members over the years.
Associations like NASDA, and the meetings they host, provide an ideal environment to advance our goals of integration and partnership.
RRT New Awards: 4 to Departments of Agriculture ($1.2M)
ISO new awards: 15 to Departments of Agriculture ($3.3M)
MFRPS CAP New awards: 10 to Departments of Agriculture ($2.9M)
Innovative Food Defense Grants: 2 to Departments of Agriculture

4. Rapid Response Teams (RRT)
Multi-year Cooperative Agreement
Awards range from $300,000 - $500,000
Develop Rapid Response Capabilities
RRT Manual (Best Practices)
Metrics
Improve Program Infrastructure
MFRPS Implementation
Strengthen Federal/State/Local Collaboration
Across programs (health, agriculture, etc)
Across initiatives (IFSS, CDC FoodCORE, etc) *
Did You Know
9 RRTs are in Public Health Agencies
10 RRTs are in Departments of Agriculture
Develop Rapid Response Capabilities (including ICS)
Metrics - to measure/quantify effectiveness and value
Why Create RRTs?
The RRT project was created to address the need for improved, integrated rapid response to food and feed emergencies. Multiple national initiatives such as the Food and Drug Administration Amendments Act (2007), formation of the President’s Food Safety Working Group (2009), and the passage of the Food Safety Modernization Act (2011) all point to the priority of this issue for the Nation.
These pilot RRTs were tasked with developing models that can be used and adopted by other programs. For example, in 2011, the RRTs documented best practices for seven core operational elements (e.g., implementing the Incident Command System (ICS) in a food emergency) in the RRT Best Practices Manual (available soon), in a format that other groups can easily customize for assessing and improving their own capabilities.
RRT Manual of Best Practices (RRT Playbook)
One of the most prominent accomplishments of the RRTs is the development of the “RRT Manual of Best Practices” (formerly known as the “Playbook”). This features tools to be used for program improvement in several key areas of response, such as communication standard operating procedures (SOPs), traceback, joint investigations and inspections, etc. The first and second (upcoming) volumes of the Manual will together establish metrics for rapid response capabilities, that would allow RRTs to assess their status, indentify improvement plans, and quantify accomplishments and impact. 
The first volume of the RRT Manual of Best Practices is expected to be shared publicly in the spring of The second volume is expected by early 2013.

5. 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
SER
KAN-DO
Rapid Response Teams (RRTs)
Original RRTs
New RRTs
Southeast Region
Central Region
NC (ATL-DO)
GA (ATL-DO)
MI (DET-DO)
PA (PHI-DO)
FL (FLA-DO)
TN (NOL-DO)
MN (MIN-DO)
WV (BLT-DO)
MS (NOL-DO)
VA (BLT-DO)
MD (BLT-DO)
Northeast Region
Southwest Region
MA (NWE-DO)
NY (NYK-DO)
TX (DAL-DO)
IA (KAN-DO)
RI (NWE-DO)
MO (KAN-DO)
Pacific Region
Summary:
Total: 19 States/14 Districts
2008: 6 States/7 Districts
2009: 3 States/3 Districts
2012: 10 States/7 Districts
WA (SEA-DO)
N/A
CA (LOS-DO & SAN-DO)
Summary:
Total: 19 States/14 Districts
2009: 3 States/3 Districts
2008: 6 States/7 Districts
2012: 10 States/7 Districts
PAR
SWR
DAL-DO
= New RRT State (Under 2012 RFA)
= RRT State (Original- Joined 2008/2009)
= Department of Agriculture

6. Announcing…
The RRT Best Practices Manual is now available upon request to DFSR
Send an to
A resource for any food regulatory program wishing to improve response capabilities
Develop Rapid Response Capabilities (including ICS)
Metrics - to measure/quantify effectiveness and value
Why Create RRTs?
The RRT project was created to address the need for improved, integrated rapid response to food and feed emergencies. Multiple national initiatives such as the Food and Drug Administration Amendments Act (2007), formation of the President’s Food Safety Working Group (2009), and the passage of the Food Safety Modernization Act (2011) all point to the priority of this issue for the Nation.
These pilot RRTs were tasked with developing models that can be used and adopted by other programs. For example, in 2011, the RRTs documented best practices for seven core operational elements (e.g., implementing the Incident Command System (ICS) in a food emergency) in the RRT Best Practices Manual (available soon), in a format that other groups can easily customize for assessing and improving their own capabilities.
RRT Manual of Best Practices (RRT Playbook)
One of the most prominent accomplishments of the RRTs is the development of the “RRT Manual of Best Practices” (formerly known as the “Playbook”). This features tools to be used for program improvement in several key areas of response, such as communication standard operating procedures (SOPs), traceback, joint investigations and inspections, etc. The first and second (upcoming) volumes of the Manual will together establish metrics for rapid response capabilities, that would allow RRTs to assess their status, indentify improvement plans, and quantify accomplishments and impact. 
The first volume of the RRT Manual of Best Practices is expected to be shared publicly in the spring of The second volume is expected by early 2013.

7. Manufactured Food Regulatory Program Standards (MFRPS)
Uniform foundation for the design and management of state programs responsible for regulating food plants
Institute a comprehensive quality assurance & standardization program
The Division of Federal-State Relations’ (DFSR) Development and Integration Branch (D&I Branch) has been busy visiting states and reviewing their state policies and standard operating procedures as part of the outreach being conducted under the Manufactured Food Regulatory Program Standards (MFRPS). The goal of the standards is to leverage resources and share common successes to build systems within state regulatory food programs. The standards promote development of a high-quality state manufactured food regulatory program and include a process for continuous improvement. Gaps are identified, improvement plans are developed and strategic goals are identified. The areas of focus include regulatory foundation, training, inspection programs, auditing, food defense, enforcement and compliance, stakeholder outreach and laboratory services.
Program Standards
Regulatory Foundation
Training
Inspection Program
Inspection Audit Program
Food-related Illness and Outbreaks and Response
Compliance and Enforcement
Industry and Community Relations
Program Resources
Program Assessment
Laboratory Support
FDA Program-Assessment Validation Audits (PAVAs) will be conducted at 18, 36, and 60 months (external to DFSR).
Currently there are 41 state agencies from 39 states and Puerto Rico enrolled with the MFRPS. 9 of these states are Rapid Response Team states.
Recently, 2 Cooperative Agreement Programs related to MFRPS have been announced. This will move MFRPS implementation away from the contract funding vehicle.
MFRPS CAP
RFA closed April, 2012
Up to $300,000/yr
Up to 5 years
ISO Laboratory Accreditation CAP
Up to $300,000/yr to seek accreditation
Up to $150,000/yr to maintain accreditation
Increased total program funding to $8 million
FDA Program-Assessment Validation Audits (PAVAs) conducted at 18, 36
Full program audit conducted at 60 months
41 State Programs (40 States) enrolled in MFRPS)

8. MFRPS Cooperative Agreement
RFA issued in late spring, 2012
Up to $300,000/yr in funding
Up to 5 years of funding
Purpose: to assist State manufactured food regulatory programs to achieve and maintain full conformance with the MFRPS
Awards recently issued
26 States
$7.1M in funding per year *
Did You Know
16 recipients are in Public Health Agencies
10 recipients are in Departments of Agriculture

9. ISO 17025 Cooperative Agreements
RFA issued in late spring, 2012
Up to $300,000/yr in funding
Up to 5 years of funding
Purpose: To support accreditation of microbiological & chemical analyses performed on behalf of state manufactured food regulatory programs
Awards recently issued
31 States
$7.8M in funding per year
Pending award
Laboratory Association to support ISO accreditation ($1.5M) *
Did You Know
14 recipients are in Public Health Agencies
15 recipients are in Departments of Agriculture
2 recipients are in Universities

10. FY12 Grants & Cooperative Agreements
Programs
# of Awards*
Food Protection Task Forces 23
Food Emergency Response Network (FERN) 34
Ruminant Feed Ban Support (BSE) 11
Rapid Response Teams 19
Innovative Food Defense 3
Small Conference Grants 9
FSMA Emergency Response & Risk Based Inspections
Awards forthcoming
Manufactured Food Regulatory Program Standards 26
ISO 17025:2005 Laboratory Accreditation 31
Voluntary Nat’l Retail Food Regulatory Program Standards
Integrated Laboratory System 1
Alliances 2
Total Funding
$44.3M
(>200 awards)
Programs # of Awards Amount
Food Protection Task Forces $166K
Food Emergency Response Network (FERN) $10.7M
Chem $5.6M
Microbiological $3.9M
Radiation $1.2M
Ruminant Feed Ban Support (BSE) $2.6M
Rapid Response Teams $7.4M
New RRT Funding Only $2.9M
GA IA MD MS MO NY PA RI TN WV(h)
Innovative Food Defense $294K
One county (Cuyahoga County, OH), two state Agriculture programs (MI and MN)
Small Conference Grants $225K
FSMA Emergency Capacity/Recall $1.2M
FSMA Inspection Capacity $2.3M
Integrated Laboratory System (Alliance) $1.5M
Manufactured Food Regulatory Program Standards $7.1M
AK AL AR CO CT GA IA IL IN KS KY MD MO NE NV NY OH OR PA RI SC(H) TN UT VT WI WV(h)
ISO 17025:2005 Laboratory Accreditation $7.8M
Voluntary Nat’l Retail Food Regulatory Program Standards 38 $2.6M
Alliances (NCSL & AFDO) $445K
Total Funding $45.6M
*Some 2012 awards have not yet been issued

11. FY12 Inspection Contract Programs
# of Awards
Food 46
Feed 36
Egg 8
Tissue Residue 21
MQSA 44
Medical Device 1
Milk Residue
N/A
Totals
$15.2M
(>150 awards)
Program States Inspections Amount
Food 44* $11.7M inspections and training
1 territory
Total 46 contracts total
Feed ,400 $2.6M
Egg K
Tissue Residue $569K
MQSA $9.M
Medical Device $85K
Milk Residue Data** $105K
*MFRPS enrollment is now open as a Cooperative Agreement as well as an option in the food contract.

12. Then & Now: Investment in Federal-State Integration
Programs
FY2009 Funding
FY2012 Funding*
Contracts (total)
$15.5M
$15.2M
Egg Contract (added FY11)
None
$320K
Grants (total)
$17.4M
$44.3M
MFRPS implementation
None (26 Programs)
$11M (41 Programs)
ISO (added FY12)
$7.8M
RRT (expanded FY12)
$4.5M
$7.4M
FSMA Emergency Response & Risk Based Inspections (added in FY12)
$3.5M
Alliances (AFDO and NCSL)
$455K
State Cooperative Programs (total)
$250K
$3.4M
Retail Standards Cooperative Agreement
$2.6M
Retail Partnership
$500K
Dairy & Shellfish
Total Funding
$33.2M
$59.54M
Total funding under contracts includes the funding provided for work under contract in following program areas:
Food: ~12M,
Feed:~3M,
Tissue Residue:~800K,
Medical Device:~120K,
Milk Drug Residue: ~85K
Total funding under grants includes funding to existing grant and cooperative agreement programs to include:
Food Protection Task Force grants: ~206K
Small Science Conference: ~225K
BSE: ~3M
FERN: ~10 M
Innovative Food Defense: ~300K
Alliance: ~450K
With increasing frequency, we learn of budget cuts and extensive furloughs of State and local employees that have resulted in a substantial reduction of State and local capacity
24 States have projected a combined shortfall of $46 billion for FY2013. This number is in addition to the nearly $430 billion shortfall amount seen over 2009, 2010, and [1] Center on Budget and Policy Priorities, States Continue to Feel Recession’s Impact
29,000 cumulative jobs were lost from 2008 to 2010, approximately 19 percent of the 2008 nationwide local health department workforce - [2] NACCHO Local Health Dept Job Losses and Program Cuts
40% of all local health departments made cuts in the at least one program area between July 2009 and July 2010 (NACCHO Local Health Dept Job Losses and Program Cuts)
Jobs have been cut in at least one program area in 38 States and 14 States have issued mandatory furloughs
Continued investment in national program standards are necessary to achieve steady improvement at the State and local levels
We have recently invested $14 million in support of the implementation of the Food Standards alone.
FDA is also building a robust infrastructure within DFSR to empower and support states as they implement MFRPS and ISO Accreditation Standards
Improvements in training and certification programs are needed to result in a uniform and consistent approach to food safety
As well as development and maintenance of an information technology structure that enables efficient data sharing
In the past 24 months, FDA has invested over $25 million into State programs, including:
MFRPS & ISO Accreditation Cooperative Agreements
Retail Voluntary Standards
Proven commitment: from 2009 to 2012, funding to State and local partners increased by $34.2 million.
*2012 awards estimated

13. FDA Division of Federal State Relations Parklawn Drive, ELEM- 3033, Rockville, MD DFSR Website: