Status/Update: FDA’s Rules for Produce Safety & Preventive Controls for Human Food

1. Status/Update:FDA’s Rules for Produce Safety & Preventive Controls for Human Food 8th Annual Commissioner’s Food Safety Forum Leanne L. Skelton Produce Safety Staff, Office of Food Safety, CFSAN, FDA on detail from Fruit & Vegetable Program, AMS, USDA

2. Background – Produce Safety 1998 Good Agricultural Practices Guidance 2008 Fresh-Cut Guidance 2009 Commodity Specific Guidances Event/Issue Guidances Existing authority under Food Drug & Cosmetics Act Currently No Implementing Regulation

3. The Rulemaking Process; It Doesn't Happen Overnight FDA proposes rule & requests comments FDA considers comments & considers revising rule FDA issues final rule setting dates for companies to comply We are almost here for Produce & PCHF

4. Research Produce Safety Rule Implementation & Compliance Education & Outreach

5. Outreach & Technical Assistance Public meetings Presentations Listening sessions Webinar invitations Alliances for education Guidance documents

6. Education • Produce Safety Alliance • www.producesafetyalliance.cornell.edu • Sprouts Safety Alliance • www.iit.edu/ifsh/sprout_safety/ • Food Safety Preventive Controls Alliance • www.iit.edu/ifsh/alliance/

7. Education

8. Research • Consideration of alternative approaches • Raw manure use as a soil amendment • Water quality for water directly applied to the edible portion of crops • Study Facilitation • Development of research protocols that can be used various agro-ecological regions • Partnerships/Engagement • Western Center for Food Safety (FDA Center of Excellence) • USDA’s NIFA, ARS, and AMS • Land Grant Universities and Cooperative Extension • Industry (Center for Produce Safety, Commodity Groups, Trade Associations)

9. Inspection and Compliance Non-Traditional Strategy • “Educate Before We Regulate” • Robust Education and Outreach • Technical Assistance • Compliance Dates • At least 1 year for small business and At least 2 years for very small business after effective date. • Formulating a Compliance Strategy • With staff from across FDA disciplines • How to utilize existing efforts

10. Context -- FSMA Sec. 105 & Sec. 103 Produce Safety Regulation Growing, harvesting, postharvest handling of produce (e.g., trimming, washing, grading) Packing of produce, where exempt from BT Act registration Preventive Controls Regulation for Human Food Packing of produce, where subject to BT Act registration Processing of produce (e.g., fresh-cut) Warehousing, shipping, receiving of produce

11. Overarching Principles & StandardsFSMA Sec. 105 – Standards for Produce Safety • Prevention: A Cornerstone for Produce Safety • Requires FDA to set forth procedures, processes, and practices reasonably necessary to: • minimize the risk of serious adverse health consequences or death; and • prevent the introduction of know or reasonably foreseeable biological, chemical, and physical hazards • Provide sufficient flexibility to be applicable • to various types of entitiesengaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and • be appropriate to the scale and diversityof the production and harvesting of such commodities. • Take into consideration conservation and environmental practice standards and policies

12. Standards for Produce Safety • Development of regulations and guidance • Includes knowledge and experiences from: • Inspections and investigations • Surveillance • Domestic and import field assignments findings • Scientific research findings • Previous public dockets • Stakeholder engagement • Farm Tours & Listening Sessions • FDA participation in association, scientific organization and other meetings • FDA public meetings and hearings

13. Preventive Controls for Human FoodWhat Congress told FDA to require relative to fresh produce Under FSMA Sec 103 (Sec 418 of the FD&C Act) facilities are required to conduct a hazard analysis and implement preventive controls for identified hazards Applies to businesses that are required to register under the BT Act of 2002 (Sec 415 of the FD&C Act [with some exemptions]) Outlines and Identifies components of HACCP (i.e., Process Control) Defines Preventive Controls Specifies what may be included in Preventive Controls

14. PCHF Details... • Exemptions….. • General Activities Outside the “Farm” Definition • Activities of “Mixed-type” Facilities that Would Make Them Subject to the PCHF • Is the “Mixed-type” facility subject to an exemption under PCHF? • Risk Analysis - what “low risk” activities & foods would be exempt for small & very small facilities?

15. Other Related Rulemaking Activity • Sanitary Food Transportation Act • Foreign Supplier Verification Program • Voluntary Qualified Importer Program • Accreditation of 3rd Party Auditors

16. Next StepsProduce Safety & Preventive Controls for Human Foods • Comment • Public Meetings (and comment…) • Dates (and comment) • Research (and….) • Education & Outreach (and…) • Implementation & Compliance (…)