FDA's current thinking on operational strategy for implementation work plans. Presentation from workshops held on April 23 ~ 24, 2015 at the Washington Marriott Hotel, DC.

1. Produce Safety Rule
Phase 2 Workgroup
http://www.fda.gov/fsma
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2. Produce Background
• FSMA mandates FDA to establish
science-­based, minimum standards for
the safe production and harvesting of
fruits and vegetables.
• In the past, FDA’s on-­farm presence has
been typically in response to events
implicating produce in illness outbreaks or
positive pathogen samples.
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3. Produce Regulation
Implementation Timeline

4. Key Principles
• Utilize a risk-­based approach to prioritize
and allocate resources for implementation
activities
• Invest in specialized training and
implement produce safety in a way that:
– Promotes consistency in regulatory approach and
decision making
– Allows the flexibility needed to recognize the diversity
and complexity of the produce farming community
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5. Key Principles
• Work closely with the farming community,
government agencies, academia, and
other partners
• Recognize the role of the marketplace in
influencing and expanding industry
compliance with the produce safety rule
• Develop meaningful public health metrics
to measure success, such as reductions in
produce-­related foodborne illnesses
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6. Partnerships
• Partnerships remain key to successful
implementation.
• FDA is currently partnering with multiple
organizations in planning implementation of
the produce safety regulations, including:
– Other federal, state, and foreign government agencies
and organizations
– Land grant universities and other academic institutions
– Produce farm and food industry associations
– Food safety professional organizations
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7. Inspections and Compliance
• By increasing education and accessibility
to technical assistance, the agency
intends to foster and facilitate compliance.
• Inspectional approach includes new ways
to enhance collaboration and assist states
to adjust and perform the majority of on-­
farm activities (as funding permits), while
FDA provides scientific support and
assistance, as needed.
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8. Training: Rule Requirements
• FDA is working with two organizations to
develop training on the regulatory
requirements of the Produce Safety Rule
– The Produce Safety Alliance (PSA), centered at
Cornell University, is developing a curriculum to help
the farming community understand the requirements
in the rule and how to comply with these
requirements
– The Sprout Safety Alliance (SSA), centered at the
Illinois Institute of Technology, is developing a
curriculum to assist sprout growers
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9. Training: Regulators
• In addition to attending Alliance training on
the requirements of the rule, regulators will
also attend regulator-­specific training.
• Regulator training will incorporate new
tools and introduce techniques needed to
perform farm inspections and achieve
consistency
− Farm regulatory inspection approach protocols
− FDA produce farm inspection reporting tools
− On-­farm bio-­security and behavior protocols
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10. Technical Assistance
• Two elements to technical assistance:
– Compliance assistance
– Science / technical support
• Partners in providing technical assistance
– FDA Technical Assistance Center
– Regional FDA Produce Safety Network
– USDA/AMS
– Land grant University Cooperative Extension Services
– PSA/SSA
– State and foreign governments
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11. On-­Farm Assessments
Program
• FDA is working with NASDA to develop a
voluntary on-­farm assessment program
• Conduct before the compliance period is in
effect to assist produce farmers with
implementation of produce rule standards
• Gain knowledge of the current state of the
farming community toward implementation
of produce regulation
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12. Leveraging
• FDA recognizes many produce safety
initiatives with significant farm accountability
systems have already been implemented
through private audits, farm associations, the
USDA AMS, and other organizations.
• FDA will continue to explore ways to leverage
these market-­driven produce safety programs
to assist in risk based resource allocation and
to inform current thinking.
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13. Reporting
• Developing new FDA inspection reporting
tools
– Use of rational questionnaires to guide regulators to
improve efficiency and consistency of inspections,
facilitate analysis and information sharing and
generate informative reports
– Comprehensive farm report including specific
resources (e.g., links to guidance) as needed to help
the farmer achieve compliance
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14. Breakout Sessions
• Looking forward to feedback on two
aspects of implementation strategy to
foster industry compliance:
– Technical assistance, outreach
– Inspection program, including on-­farm assessments
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15. Thank You
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