U.S. Food & Drug AdministrationOffice of Regulatory Affairsg y

Division of Federal- State Relations (DFSR) Update

AAFCO Midyear MeetingJanuary 18, 2011

J R dJoe ReardonDirector, Division of Federal-State Relations

Introduction• DFSR Current Initiatives • Communication• Reportable Food Registry

(RFR)• Commissioning• Commissioning• Grants and Contracts• Program Standards: Food g

and Feed• Food Safety

M d i ti A tModernization Act

DFSR Current Initiatives• Establish Quality Management System

– Standard Operating Procedures across all program areas– Measurement of Key Quality Indicators

• Create dynamic communication platform– Framework for interaction with and outreach to state and local partners

• Commissioning- Food, Feed, Center for Tobacco Products (CTP)

f• Increased funding through grants and contracts– Future Contracts: Egg Inspections, Menu Labeling

• Program Standards for Food and Feed

Expanding Communications• Field Management

Directive– Routine– Work planning

E i– Emergencies• New communication

platformsplatforms• Strengthen and

broaden partnershipsbroaden partnerships

Reportable Foods Registry (RFR)

• DFSR oversees the contact database of state and local commissioned officials who have beenand local commissioned officials who have been identified as state RFR contacts.

• Revised to automatically distribute email notifications of RFR events to districts and states simultaneouslysimultaneously.

• The state contacts who receive the notifications FDA i i d ffi i lare FDA commissioned officials.

Updated Commissioning Process• Mandatory Background Investigations for all

Commissioned Officials seeking pocket credentials.credentials.

• Composed of 3 parts: – Criminal– Credit– Reference/Sit Down Interview with InvestigatorReference/Sit Down Interview with Investigator

• DFSR working in conjunction with the Office of Security Operations on the updated processSecurity Operations on the updated process.

Grants/Cooperative Agreements FY 2010Programs # of States AmountFood Protection Task Forces 27 $200KFood Protection Task Forces 27 $200K

Food Emergency Response Network (FERN)

Bi l i l– Biological– Microbiological– Radiation 34 $10.0M

Feed Safety & Ruminant Feed Ban Support (BSE) 12 $3.0M

Rapid ResponseRapid Response Teams 9 $4.5M

Innovative Food D f 2 $200KDefense 2 $200K

Small Conference Grants 5 $125K

Rapid Response Teams (RRT)• 3-year cooperative agreement with 9 states3 year cooperative agreement with 9 states

– Began in 2008 with 6 States (CA, FL, MA, MI, MN, NC)– 3 new in 2009 (TX, VA, and WA)

• RRT best practices in food/feed incident response = PlaybookRRT best practices in food/feed incident response Playbook– For use by RRTs and non-RRTs

• Response capability assessment and improvement• Consequence management

• 8 Chapters (RRT Working Groups: Oct Dec 2010)• 8 Chapters (RRT Working Groups: Oct-Dec 2010)1. Working with Other Agencies2. Food Emergency Response Plans3. Communication SOPs4 Incident Command System4. Incident Command System5. Training6. Tracebacks7. Joint Investigations8. Telling the RRT Story

• Future of RRT

Contracts FY 2010Program States Inspections AmountFood 42* 11,392 $9.8MFeed 36 5 400 $2 5MFeed 36 5,400 $2.5MTissue Residue 19 260 $318KMQSA 46 7,373 $9.6MMedical Device 1 20 $85KMilk Residue Data** $105K

24,445 $22.4M

*45 Total Contracts- 42 States and Puerto Rico, WV and SC both have 2 contracts

**Analysis of over 4 million milk residue sample analysis

Program Standards: Food and FeedFood and Feed

• Role in National Integrated Food Safety System

• Benefits of Regulatory Program StandardsStandards

De eloping Feed Standards• Developing Feed Standards

Manufactured Food Regulatory Program StandardsProgram Standards

• 30 Programs in 29 States have implemented

• 5 Pilot States in 2007

• 18 implemented standards in 2008

• 4 implemented standards in 2009

• 2 implemented standards in 2010• 2 implemented standards in 2010

• 9 RRT states include implementation of standards

MFRPS States

Standard OneCatalogs State authority to

conduct inspection work

Standard SixGuarantees State authority to take enforcement actions on inspection

work

Relationship between Standards and State Food Manufacturing

Programs

Standard TwoEnsures State’s training to conduct inspection work

Standard SevenEncourages outreach to all

stakeholders impacted by State kconduct inspection work

Standard ThreeEstablishes well defined State

inspection program to allo state to

work

Standard EightAssists States in determining

resources needed to run State Manufactured

F d Pinspection program to allow state to conduct inspection work

Standard Four

manufactured food program and conduct inspection work

Standard Nine

Food Programs

Enables States to monitor competent inspection work

Standard Five

Provides States with snapshot of compliance with MFRPS

Standard FiveDocuments process for

Foodborne illness and rapid response capability

Standard TenReferences regulatory lab support

for inspection work

MFRPS Measures and BenchmarksBenchmarksStandard Three

Establishes well defined State inspection program to allow state to

conduct inspection work

An Element of ComplianceBenchmark

Necessary Components

Benchmark

M f t d F d R l tManufactured Feed Regulatory Program Standards g

• Development committee structure:– Project Manager: DFSR

Project Administrative Support: DFSR– Project Administrative Support: DFSR– Co-chairs: AAFCO and CVM– Members:

2 FDA District Representati es» 2 FDA District Representatives» 3 State Regulatory Agency Representatives» 1 FDA Division of Federal-State Relations

1 FDA Di i i f H R D l t» 1 FDA Division of Human Resource Development» 2 FDA Center for Veterinary Medicine» 1 AAFCO Lab Committee Representative» 1 FDA Division of Field Sciences Representative

M f t d F d R l tManufactured Feed Regulatory Program Standards Timelineg

• December 2010- January 2011: Establishment of steering committee, project design, timeline and work planplan

• February 2011: Face to face committee meeting to begin standards developmentstandards development

• March - October 2011: Standards developed and finalizedfinalized.

• October- December 2011: Standards receive agency l d t d t th F d l R i tclearance and are posted to the Federal Register

Food Safety Modernization ActSigned January 4 2011Signed January 4, 2011

• Preventive ControlsPreventive Controls

• Inspection, Compliance, and Responseand Response

• Imports

• Partnerships

• Training

Q&AQ&A

Joe Reardonjoseph.reardon@fda.hhs.govjoseph.reardon@fda.hhs.gov