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

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Overview

• ORA Strategic Priorities

• Where we are now with funding & standards

• Where we want to be in the future

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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 ORA’s training and professional development opportunities. Responsible Office: ORM a. Host a Food and Feed Training meetings to include key external stakeholders.

ORA FY 15 Priorities

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GOAL 3: LEVERAGE AND EXPAND ORA’S PUBLIC HEALTH PARTNERSHIPS. 3.1: Strengthen ORA’s 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.

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d. Advance ORA’s contribution towards the Partnership for Food Protection.

e. Facilitate continued progress on FDA’s 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.

ORA FY 15 Priorities

GOAL 3: LEVERAGE AND EXPAND ORA’S PUBLIC HEALTH PARTNERSHIPS. 3.1: Strengthen ORA’s relationships with Federal, State, and Local Public Health Partners. Cont.

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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)

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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)

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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

• 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

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FY 13-15 Contract Inspections - Summary

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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 17025:2005 Laboratory Accreditation 30

Voluntary Nat’l Retail Food Regulatory Program Standards 35

Integrated Laboratory System 1

Alliances 2

Retail Association 1

FoodSHIELD 1

Farm Survey (NASDA) 1

Total Funding $44M

FY14 Grants & Cooperative Agreements

Integrated Food Safety System (IFSS)

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• 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)

“A national IFSS must be built upon mutual reliance and respect among partner agencies, recognizing and understanding each participant’s roles, limitations, and authorities…”

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The Backbone:Grant and Cooperative Agreements – Standards

Supporting Food/Feed Safety Through Capacity Building and Integration with National Program Standards

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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

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.

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• Recognition of state challenges/significant events/resources to facilitate FDA’s immediate support/response

• Original 9 RRT States – Expect 100% implementation by July 2015 

• By 2017: > 90% State programs at full implementation

• Promote sustainability, accountability and leverage resources

• Facilitate mutual reliance and IFSS approach

MFRPS Future Direction

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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

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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

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FDA Retail Food Safety Initiative & the Retail Program Standards

• Goal : “Create an enhanced local regulatory environment for retail food operations”

– Objective 1: “Promote wider implementation…of 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”

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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

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Food Protection Task Force Conference Program Grants

Industry

FDA Taskforce GrantAcademia

Law Enforcement

Public Health Officials

Consumer Groups

Current Grantees

• 15 States & D.C.

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Baseline Funding OPTIONAL Pick List/Menu Options

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)?

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 development:$XX/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)?

Must Choose: May Choose:

MFRPS Implementation (Development) •Development rate (Pending availability of funds and acceptable Grantee performance): up to $XX/year/grantee

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.

Future Funding Approach

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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

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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

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Moving forward…Opportunities….

• 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 25

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