1. Produce Safety Rule Phase 2 Workgroup http://www.fda.gov/fsma 1

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. 2

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 4

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 5

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 6

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. 7

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 8

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 9

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 10

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 11

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. 12

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 13

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 14

15. Thank You 15