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Funding Opportunities for State, Local, Tribal and Retail/Manufactured Food Regulatory Programs CASA 2015

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Title: Funding Opportunities for State, Local, Tribal and Retail/Manufactured Food Regulatory Programs CASA 2015


1
Funding Opportunities for State, Local,
Tribal and Retail/Manufactured Food Regulatory
Programs CASA 2015
  • Barbara Cassens, Senior Advisor, Acting Director
    Office of Partnerships, FDA Office of Regulatory
    Affairs

2
Overview
  • ORA Strategic Priorities
  • Where we are now with funding standards
  • Where we want to be in the future

3
(No Transcript)
4
ORA FY 15 Priorities
GOAL 1 RECRUIT, TRAIN, DEVELOP AND RETAIN A
DIVERSE WORLD CLASS WORK FORCE AND PROMOTE AN
ORGANIZATIONAL CULTURE OF INTEGRITY, EXCELLENCE,
AND COLLABORATION.
1.2 Expand ORAs training and professional
development opportunities. Responsible Office
ORM a. Host a Food and Feed Training meetings
to include key external stakeholders.
5
GOAL 3 LEVERAGE AND EXPAND ORAS PUBLIC HEALTH
PARTNERSHIPS. 3.1 Strengthen ORAs
relationships with Federal, State, and Local
Public Health Partners.
a. Evaluate the utilization of state contracts.
b. Maximize the utilization of State Cooperative
Agreements and Grants.
c. Enhance work planning by capitalizing on
ORA-State relationships.
6
ORA FY 15 Priorities
GOAL 3 LEVERAGE AND EXPAND ORAS PUBLIC HEALTH
PARTNERSHIPS. 3.1 Strengthen ORAs
relationships with Federal, State, and Local
Public Health Partners. Cont.
d. Advance ORAs contribution towards the
Partnership for Food Protection.
e. Facilitate continued progress on FDAs mutual
reliance initiatives, including sharing and
utilizing state data.
f. Identify training needs and strategies for
expanding training to state partners.
g. Collaborate with partner associations and
alliances.
7
FSMA Section 205- Surveillance
  • Will enable the development of strategies to
    leverage and enhance capacities to improve the
    following (205c1)
  • Foodborne illness surveillance, outbreak response
    and containment
  • Inspections safety standards
  • Partnerships Information sharing
  • (RRT, FERN, MFRPS, AFRPS, Alliance, FoodSHIELD,
    IFD, Retail, SSCG, FPTF, Funded Workshops,
    Partnership Funds)

8
FSMA Section 209- Improving the Training of
State, Local, Territorial and Tribal Officers
  • Set standards and administer training and
    education programs for food safety officials
    (State Contracts, MFRPS, Alliance, ISO/Lab,
    Retail, Funded Workshops, Risk Factor Study,
    FoodSHIELD, FPTF)
  • Provide consistency and equivalency among Federal
    State Programs (MFRPS, AFRPS, Alliance,
    ISO/Lab, RRT, FERN, Retail)

9
FSMA Section 210- Enhancing Food Safety
  • Direct investment in the infrastructure of State
    and local capacities (MFRPS, AFRPS, ISO/Lab
    Assoc, RRT, FERN, Retail)
  • Eligible entities will be able to
  • Build the food safety capacity of the
    laboratories
  • Build the infrastructure and capacity of food
    safety programs (investigations, response,
    training)
  • Increase capabilities and capacities of State
    programs

10
FY 13-15 Contract Inspections - Summary
  • Food
  • 2014-2015 11,047
  • 2013-2014 11,280
  • 2012-2013 10,873
  • Feed
  • 2014-2015 4,306
  • 2013-2014 5,030
  • 2012-2013 5,224
  • Tissue Residue
  • 2014-2015 312
  • 2013-2014 335
  • 2012-2013 375
  • MQSA
  • 2014-2015 6,923
  • 2013-2014 6,917
  • 2012-2013 6,861
  • Egg
  • 2014-2015 92
  • 2013-2014 55
  • 2012-2013 136
  • Medical Device
  • 2014-2015 20
  • 2013-2014 20
  • 2012-2013 20

11
FY14 Grants Cooperative Agreements
Programs of Awards
Food Protection Task Forces 15
Food Emergency Response Network (FERN) 34
Ruminant Feed Ban Support (BSE) 11
Rapid Response Teams 18
Innovative Food Defense 2
Small Science Conference Grants 10
FSMA Emergency Response Risk Based Inspections 33
Manufactured Food Regulatory Program Standards 37
ISO 170252005 Laboratory Accreditation 30
Voluntary Natl Retail Food Regulatory Program Standards 35
Integrated Laboratory System 1
Alliances 2
Retail Association 1
FoodSHIELD 1
Farm Survey (NASDA) 1
Total Funding 44M
12
Integrated Food Safety System (IFSS)
A national IFSS must be built upon mutual
reliance and respect among partner agencies,
recognizing and understanding each participants
roles, limitations, and authorities
  • Federal, State, local, tribal, territorial
    regulatory public health partners
  • Working collaboratively across all jurisdictions
  • To provide comprehensive, coordinated coverage of
    the food supply from farm-to-table
  • Outcome Prevention of foodborne illness in
    humans and animals
  • Accomplished, in part, through the Partnership
    for Food Protection (PFP)

13
The Backbone Grant and Cooperative Agreements
Standards Supporting Food/Feed Safety Through
Capacity Building and Integration with National
Program Standards
14
Manufactured Food Regulatory Program Standards
(MFRPS)
  • First released in 2007 in response to an HHS OIG
    report recommending FDA take steps to promote
    equivalency among Federal and State food safety
  • Using MFPRS to support FSMA Section 201 and IFSS
  • Regulatory foundation
  • Training
  • Inspection and assessment
  • Compliance and enforcement
  • Outbreak and response
  • Laboratory support

15
MFRPS Sustainability
  • Sustainability Plans are now required for States
    enrolled in the MFRPS Program.
  • States must submit an Exit Strategy of
    Sustainment (ESS) to FDA for approval in the 5th
    year of the cooperative agreement, or sooner if
    warranted.
  • MFRPS Sustainability recognizes changes in new
    emerging issues, legal mandates, new scientific
    research/risk assessments and changes in industry
    and consumer trends.
  • Primary resource required for State
    Sustainability Personnel
  • Recognizing partnerships between FDA-State
    programs to support the National IFSS.

16
MFRPS Future Direction
  • Recognition of state challenges/significant
    events/resources to facilitate FDAs immediate
    support/response
  • Original 9 RRT States Expect 100
    implementation by July 2015 
  • By 2017 gt 90 State programs at full
    implementation
  • Promote sustainability, accountability and
    leverage resources
  • Facilitate mutual reliance and IFSS approach

17
FSMA Preventive Control Rule MFRPS
Challenges/Opportunities
  • FSMA will have a direct effect on States and
    future changes and implementation of the MFPRS
  • States enrolled in the MFPRS have an advantage
    with evaluating their current systems and
    identify necessary changes to meet FSMA
  • Standard 1 (Regulatory Foundation) -
    Incorporation of new Rule, e.g., 21 CFR 117
  • Standard 2 (Training Program) -
  • Immediate need for phase-in process for States
    using federal resources
  • Training sources, availability and timeliness
  • Standard 3 (Inspection Program)
  • Shift to risk-based, preventive/process control,
    and component inspections
  • Greater focus on sampling programs and assignments

18
ORA/OP/SIS Support for Animal Feed Program
Standards (AFRPS)
  • 2nd Year Goals and Opportunities
  • Cooperative agreement funding
  • Growth with enrollment and implementation (from
    12 state programs in FY14 to 24 in FY15)
  • Challenges Adoption of the Preventive Controls
    for Animal Food Rule will be a change for the
    States, e.g., 21 CFR 507

19
FDA Retail Food Safety Initiative the
Retail Program Standards
  • Goal Create an enhanced local regulatory
    environment for retail food operations
  • Objective 1 Promote wider implementationof the
    FDA Voluntary National Retail Food Regulatory
    Programs Standards
  • Objective 3 Seek increased multi-year funding
    for state, local, and tribal food safety programs
    as part of an integrated food safety system

20
Retail Program Standards
  • 2,300 (Approx. of jurisdictions eligible to
    enroll)
  • 631 (or 27) ( of enrolled jurisdictions as of
    Oct 2014)
  • 35 ( of enrolled jurisdictions with
    OP-administered, multi-year Retail Program
    Standards Cooperative Agreements in FY15)
  • 149 ( of enrolled jurisdictions receiving
    funding through cooperative agreement with AFDO
    in FY15)
  • FDA personnel involved with advancing this
    initiative
  • ORA Retail Food Specialists, DSCPs, OP, DHRD
  • CFSAN Retail Food and Cooperative Program
    Integration Staff

21
Food Protection Task Force Conference Program
Grants
  • Current Grantees
  • 15 States D.C.

22
Baseline Funding
Future Funding Approach
OPTIONAL Pick List/Menu Options
Must Choose
May Choose
  • MFRPS Implementation (Development)
  • Development rate (Pending availability of funds
    and acceptable Grantee performance) up to
    XX/year/grantee
  • Food Protection Task Force (meetings/workshops)
  • Standard rate grant XX/year/grantee
  • Available during Development and Maintenance
  • Rapid Response Team (RRT) (Maintenance)
  • Funding scheme for developmentXX/year/grantee
  • Funding scheme for maintenance (transition from
    development to maintenance after 3 years
    funding)
  • Variable funding (see criteria for levels below)
  • Level 1 XX
  • Level 2 XX
  • Level 3 XX
  • Cost matching requirement
  • Levels are based on foodborne illness outbreak
    risk or major food/feed emergency. The following
    factors may be used of firms- inventory of
    natural disasters on average of recalls from
    firms in your state Indicator for rate of
    food/feed outbreaks (NORS) high risk
    population population
  • Still TBD Where to draw the thresholds between
    each level (i.e. what is 1 vs. 2 vs. 3)?

OR
  • MFRPS Maintenance (Maintenance)
  • Variable funding (see criteria for levels below)
  • Level 1 XX
  • Level 2 XX
  • Level 3 XX
  • Cost matching requirement
  • Levels are based on the number of firms in the
    state (Active State Inventory) and other relevant
    factors (may include population, inspection
    frequency, risk, etc.).
  • Still TBD Where to draw the thresholds between
    each level (i.e. what is 1 vs. 2 vs. 3)?

Award base funding tracks (MFRPS) first (if
recommended for funding by objective review
panel), and then allocate whatever remains of the
total program funding to optional pick list/menu
options in a prioritized manner based on
objective review panel ranking of proposals.
23
Challenges for the Future
  • FSMA regulations/implementation will be
    adopted/executed differently by different state
    agencies
  • Contract inspections will still exist however,
    we will need to offer a flexible funding model to
    accommodate the interests and needs of state
    regulatory programs

24
Future
  • The produce rule is a game changer to do it
    right will require the largest inspectional shift
    and most likely will require a unique funding
    vehicle (current work with NASDA)
  • States need more time for preventive control
    regulations outreach and internal
    training/external education
  • ORA/OP promotes the increased quality of state
    regulatory programs to improve overall
    consistency and confidence in the work by these
    agencies
  • Considerable time and resources needed to adopt
    preventative Animal Food and Feed Regulations

25
Moving forwardOpportunities.
  • Multiple funding models that account for
    differences between state programs transition
    plan 
  • Electronic data collection/sharing between FDA
    and State programs  
  • Define metrics that better measure effectiveness
    of inspections/value of integration
  • Defining mutual reliance through pilots/models

26
(No Transcript)
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