MFRPS: Where We’ve Been and Where We are Going- Sustainability Steve M. Solomon, DVM, MPH

Deputy Associate Commissioner for Regulatory Affairs FDA/Office of Regulatory Affairs

Barbara Cassens

Acting Director, Office of Partnerships FDA/Office of Regulatory Affairs March 10, 2015

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Investments: Integrated Food Safety System

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From 2009-2014, FDA has invested in the following activities:

– Contracted Inspections – Lab Science – Integration and Innovation – Standards 2

Investments in IFSS: Lab Science

• • ISO 17025 Cooperative Agreement – Purpose - microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs be conducted within scope of ISO/IEC 17025:2005 accredited lab and goal of achieving and advancing nationally IFSS. – – Data available for FDA enforcement actions and surveillance purposes (30) lab grantees Lab Association (APHL) Cooperative Agreement – Purpose - facilitate long-term improvements to the national food and animal feed safety system by strengthening multi-disciplinary lab collaboration and equivalency – Provides adult education/training programs and establishes a formal, integrated lab community to advance the sharing, equivalency, and acceptability of lab results in support of public health goals.

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Investments in IFSS: FERN CAPs

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FERN (Micro, Chem and Rad) 34 state labs (Micro = 15, Chemistry = 14, Radiological = 5) Accomplishments

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Menu2010 and RadEx Alpha/ Beta Interlaboratory Comparison Study ( FERN Rad )

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For all FERN labs to increase national capability, capacity, preparedness response to radiological threat to the nation’s food supply

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Participated in every large scale chemistry event since the inception of the program (melamine in pet food; melamine in infant formula; Deep water Horizon Oil Spill, Arsenic in rice and juice) ( FERN Chem )

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Activated in every large scale microbiologic outbreak since the inception of the program (E.coli/spinach; Salmonella/peppers; Salmonella/peanut butter) ( Micro ) FERN

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Analyzing avocados since May 2014 High Volume Surveillance Sampling Program (FERN Micro)

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National conventions/inauguration food defense surveillance assignments ( All )

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Investments in IFSS: Integration and Innovation

Alliance CAP

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Purpose - facilitate long-term improvements to national food safety system by strengthening collaborations, improving States’ regulatory & surveillance protection programs for manufactured foods, and providing assistance to State legislatures on key food safety issues.

Innovative Food Defense Grant

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Purpose - generate food defense tools and resources that are easily replicated and can complement, aid in the development of, or improve State, local, Tribal and territorial (SLTT) food defense programs.

Small Science Conference Grant

- Purpose – to host annual scientific conferences, seminar, workshop, or

symposium with a topic of interest and relevance to the FDA Center supporting the grant

- 10-20 grantees (semi-annual awards) 5

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Investments in IFSS: Integration and Innovation

FoodSHIELD CAP

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Purpose - continued development and operations of collaborative online tools involving stakeholders for the purposes of (1) information sharing in the development of an IFSS, and (2) developing and implementing a sustainable model for continued collaborative communication and information sharing.

(1) grantee with sub-awards FPTF

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Purpose – provides $10K in grant funding for grantees to hold Task Force meetings with stakeholders to execute food protection projects

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Food Protection Task Force meetings foster communication and cooperation and collaboration within the States among State, local, and tribal food protection, public health, agriculture, and regulatory agencies.

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15 states & D.C.

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Investments in IFSS: Food Protection Task Force

FDA Taskforce Grant Academia

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Current Grantees 15 States & D.C.

Consumer Groups Law Enforcement Industry Public Health Officials

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Investments in IFSS: Rapid Response Team CAP

• • • Purpose- provides funding to 18 state food programs to build multi-jurisdictional RRTs to improve response to outbreaks and other emergencies 18 states and 14 FDA Districts in program Evaluated annually – CAP Milestones/requirements • Tracks development of processes, procedures and training • Includes a Capability Assessment Tool that captures multiple response data sets including general response information (e.g., tracebacks) 8

Investments in IFSS: Rapid Response Team CAP

• • • Purpose- provides funding to 18 state food programs to build multi-jurisdictional RRTs to improve response to outbreaks and other emergencies 18 states and 14 FDA Districts in program Evaluated annually – CAP Milestones/requirements • Tracks development of processes, procedures and training • Includes a Capability Assessment Tool that captures multiple response data sets including general response information (e.g., tracebacks) 9

Voluntary National Retail Foods Regulatory Program Standards

• • • Standards provide: – A guide to design and management of a retail food program – A tool to evaluate the effectiveness of food safety interventions Approximately 2300 jurisdictions eligible to enroll 631 ((27%) enrolled jurisdictions as of October 2014 10

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Animal Feed Regulatory Program Standards

Currently the States do a majority of the feed work (~ 80%) First year goals and opportunities: 12 States enrolled (contract) – Foundation Development – Gathering and sharing resources Second year goals and opportunities: ~12 (Coop agreement) – Challenges – Adoption of the Preventive Controls for Animal Food Rule will be a significant change 11

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FDA MFRPS Evaluation and Trends Analysis

• • FDA developed Program Element (PE)worksheets (tool) to assist with evaluation of State program MFRPS implementation/progress Measures “Yes” (meets), “No” (gap(s) identified), or “NA” (not applicable) Excel metric database developed to store PE data and allows for trends analysis by: – – Individual program standards Individual program element – State progress over a period of time – Identification of gaps to redirect national resources and training 13

FDA MFRPS Evaluation and Trends Analysis

• • FDA developed Program Element (PE)worksheets (tool) to assist with evaluation of State program MFRPS implementation/progress Measures “Yes” (meets), “No” (gap(s) identified), or “NA” (not applicable) Excel metric database developed to store PE data and allows for trends analysis by: – – Individual program standards Individual program element – State progress over a period of time – Identification of gaps to redirect national resources and training 14

FDA MFRPS Data Analysis by State

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FSMA: Preventive Control Rule & MFRPS Challenges and Opportunities

FSMA will have a direct effect on States and changes implementation/conformance status of the MFRPS States enrolled in the MFRPS have an advantage with evaluating their current systems and identifying 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 inspection types Greater focus on sampling programs and assignments 16

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FSMA: Preventive Control Rule & MFRPS Challenges and Opportunities

Standard 5 (Food-related Illness & Outbreaks & Response) – – Strong foundation in place through RRT and PFP • Standard 10 (Laboratory Support) – Success dependent on ISO laboratory accreditation and expansion of scope of work • FDA needs Manufactured Food Regulatory Program Alliance to assist: – Focus on how to best address these challenges – Propose changes/updates to the MFRPS – Use outreach mechanisms with State partners 17

MFRPS Sustainability

• • • • Recognition of state challenges and need for FDA support MFRPS Sustainability recognizes changes in new emerging issues, legal mandates, new scientific research/risk assessments and changes in industry and consumer trends.

– 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 5 th year of the cooperative agreement, or sooner if warranted.

Primary resource required for State Sustainability: Personnel Leveraging, collaboration and active engagement between FDA State partners are needed to sustain MFRPS and support the National IFSS 18

Moving Forward: Opportunities

• • • • • Flexible, risk-based, multi-year work plan between FDA and State partners Multiple funding models that account for differences between state programs with transition plan Electronic data collection/sharing between FDA and State partners Measure effectiveness of inspections/value of integration Defining mutual reliance model(s) 19

Moving Forward: Future Funding

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One size does not fit all Need assistance in thinking about managing sustainability Need to work with appropriators at the Federal/State/Local level to sustain and enhance funding for food safety Science Board and GAO study

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Moving Forward: Grant Management

Build strong food safety programs by combining similar cooperative agreements (i.e., MFRPS, RRT, FPTF) Development Stage – Develop infrastructure and capacity • Implement standards • Ensure there is a well trained workforce • Focus on procedure development • Quality management/continuous improvement – FDA tracks and evaluates progress 21

Moving Forward: Grant Management

• • Maintenance Stage – – Maintain conformance with standards Assist other grantees in specialized areas – – Maintain well trained workforce Review and improve procedures – – Quality management/continuous improvement Acquire data to assist FDA (not currently done) • Mission, Integration, IFSS, FSMA, etc.

FDA tracks and evaluates progress 22

Possible Future Funding Approach Baseline Funding Must Choose:

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MFRPS Implementation (Level I)

Development rate: pending availability of funds and acceptable Grantee performance

OPTIONAL Pick List/Menu Options May Choose:

• Food Protection Task Force (meetings/workshops) Standard rate grant

OR MFRPS Maintenance (Level II)

• • Variable funding • Level 1 • • Level 2 Level 3 Cost matching requirement • Levels are based on the number of firms in the state (Active State Inventory) and state population.

• Still TBD: Where to draw the thresholds between each level (i.e. what is 1 vs. 2 vs. 3)? • •

Rapid Response Team (RRT)

Funding scheme for development Funding scheme for maintenance (transition from development to maintenance after 3 years’ funding): • Variable funding • • Level 1 Level 2 • Level 3 • 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 (FoodNet or NORS); % high risk population; % population Still TBD: Where to draw the thresholds between each level (i.e. what is 1 vs. 2 vs. 3)? 23

Benefits of New Model

• • Will consolidate funding for programs with inter related activities/goals Same personnel working on many CAs – If different, it forces them to work together/improves efficiencies for State and FDA – Will align due dates and reporting • Two larger progress reports to review rather than 6 separate reports – Still QMS focused – Moves into a variable rate funding model and requires state cost matching during longer term maintenance stage 24

EPA, FSIS & CDC Funding Models

• • • EPA: states carry out federal compliance/ enforcement programs with substantial financial support from EPA. EPA must step in to accomplish work if the state cannot.

FSIS: FSIS maintains primacy for most interstate product and delegates its responsibilities to states (with substantial financial support from USDA) for intrastate and limited interstate commerce. FSIS must step in to accomplish work if the state cannot.

CDC: Cooperative Agreement requires states to work with CDC and acquire needed outbreak investigation data 25

Moving Forward: Engagement

• • • • How do we address challenges that FSMA will pose to MFRPS?

How do we develop future funding models to sustain MFRPS?

How do we better communicate how MFRPS and other investments help build an integrated national food safety system?

How do we collectively tell our story to engage appropriators at all levels?

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