California Grocers Association and United Fresh Produce Association Food Safety Modernization Act: The Impact on Ret

1. California Grocers Association and United Fresh Produce Association Food Safety Modernization Act: The Impact on Retail Webinar David E. Gombas, Ph.D. and Jeff Oberman United Fresh Produce Association May 20, 2013

2. United Fresh History of Service

3. United Fresh History of Service

4. United Fresh Today • 1,200 member companies in over 30 countries • 7,000 individual members • Commitment to serve entire produce supply chain • Strong representation from each segment • Market Segment Boards: Grower-Shipper, Wholesaler-Distributor, Fresh-Cut Processor, Retail-Foodservice • Expert Policy Councils: Food Safety, Government Relations, Supply Chain Logistics and Nutrition • Over 100 commodity and regional-specific associations • Led by 40-member Consolidated Board of Directors

5. The United Fresh Mission Growing Sales and Profitability for the entire Produce Industry Shape government policy to create a positive business environment Develop standards and best practices to increase business efficiency and profitability Create tools, services and business opportunities for members to succeed throughout all segments of the produce industry Inspire ConfidenceIncrease Consumption

6. Retail Produce Manager Awards • 9th Year of the Program • Recognition front line in supermarkets working to increase sales & consumption of fresh produce • Since 2005 • Received 1,600 +Nominations • Honored 170+ managers • From 60+ banners • Thanks to sponsor Ready Pac

7. Fresh Facts on Retail • United Fresh, Nielsen • Quarterly report tracks retail produce sales and performance • Top-line data on top 10 commodities, value-added produce, prepared foods, deli and organics

8. The Produce Industry Leadership Program

9. United Fresh Executive Development Program

10. Produce Inspection Training Program

11. For more information contact Jeff Oberman 831-600-822

12. Know Your Market. Engage Your Consumer

14. Food Safety Modernization Act • Generally supported by food industry • Produce wants comprehensive food safety platform across all production and distribution • Signed by President Obama Jan 4, 2011 • Phased-in implementation over next three years • Requires at least 12 new regulations from FDA

15. Most Direct Impact On Retail • Notice of Reportable Foods Posted in Stores • When producers/manufacturers find contamination in their products, they must report it to FDA Reportable Foods Registry • FSMA requires FDA to publish a summary of all reports on the FDA website • If a grocery chain (15 or more stores) sold such food, then the store would be required to prominently display the summary within 24 hours for 14 days • Proposed rule, details expected soon – stay tuned!

16. Most Direct Impact On Retail • Distribution Centers/Warehouses • Under proposed regulation for Preventive Controls for Food Facilities, any facility that holds food would be covered • This will require formal food safety plans, preventive controls, monitoring, record-keeping, etc. • More to come on this later as well.

17. Indirect Impact On Retail • New regulations for food producers and manufacturers will dramatically affect your suppliers • You can count on: • Confusion • Concern • And costs • Nowhere is this more true than produce

18. Food Safety Modernization Act Sec. 105 Standards For Produce Safety: FDA “shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.”

19. Five FSMA Proposed Rules • Produce Safety • Preventive Controls for Human Food • Includes focus on all food facilities • Preventive Controls for Animal Feed • Foreign Supplier Verification • Third Party Accreditation • And more to come…

20. Five FSMA Proposed Rules • Two proposed rules issued thus far • Produce Safety • Preventive Controls for Human Food • Now in public comment period • All stakeholders are encouraged to submit comments to FDA on the rules • Comment period to end May 16, although we are requesting extension

21. The Produce Rule:Standards For The Growing, Harvesting, Packing, And Holding Of Produce For Human Consumption • 142 pages, as published in Federal Register • First 124 pages are “preamble” • Explains FDA’s thought process • Asks specific questions, soliciting comment on what they have/have not proposed • Actual proposed rule is last 18 pages • 15 Subparts

22. What’s covered, what’s not • Applies to raw agricultural commodities, including fruits and vegetables, mushrooms, tree nuts, sprouts and mixes of intact fruits and vegetables • Applies to domestic and imported produce • Some items considered “rarely consumed raw” not covered • Exempts fruits and vegetables that are heat processed with a bacteria kill step • This section of proposed rule is likely to receive substantial public comment, both pro and con

23. Specified risk factors • Worker health and hygiene • Agricultural water, e.g. irrigation water, sprays, etc. that contact the produce • Animal-derived soil amendments (compost) • Animals (wildlife and domestic) • Facilities and food contact surfaces (equipment, tools, instruments and controls, transport) • Subpart M: specific requirements for sprouts

24. Specified risk factors • In general, produce industry agrees that these are the major risk factors that must be managed • Many commodities are already doing what FDA proposes, or more • Leafy greens, tomato, cantaloupe producers have aggressively developed best practices, some with enforcement mechanisms • Yet some commodities probably don’t require the same practices for safety • Treefruit, products grown above ground, bananas protected by a peel, greenhouse, etc. • FDA will have to sort this out

25. Meanwhile, what about facilities? The Preventive Controls Rule: Current Good Manufacturing Practice And Hazard Analysis And Risk-based Preventive Controls For Human Food • 178 pages, as published in Federal Register • Actual proposed rule pages 3798-3811 • Many specific requests for comment, but entire document is open for comment

26. Key requirements for facilities • Hazard Analysis and Risk-Based Preventive Controls • Written food safety plan • Hazard analysis • Preventive controls to address hazards • Monitoring of effectiveness • Corrective actions • Validation

27. Who does this apply to? • Operations required to register with FDA • Engaged in the manufacturing/processing, packing, or holding of food for consumption in the United States

28. What about retail DCs/warehouses? A: If a facility is a "retail food establishment", storerooms for the retail food establishment that are co-located with, and thus, part of, the retail food establishment, are not required to be registered. However, a distribution center or warehouse that is not at the same general physical location as the retail food establishment does not meet the definition of "retail food establishment" because it does not sell food from the facility directly to consumers. Thus, the distribution centers and warehouses are required to be registered.

29. Buyer Beware Among the exemptions • Qualified operations/facilities • Operations with less than $500,000 annual food sales • Selling majority of foods direct to consumers (including store door delivery) • In-state or within 275 miles • Farms with annual sales < $25,000/year

30. Rulemaking Process • FDA publishes proposed rule in Federal Register (January 16, 2013) • Public comment period: 120 days(May 16; subject to extension) • FDA publishes final rule within 1 year after comments close (2013-’14) • Two year implementation (2016 likely first year of enforcement) • Dates to be staggered for small (3 years) and very small (4 years) operations • Plus 2 years for some water requirements

31. United Fresh Evaluation, Comments Working groups organized from United Fresh leadership for each proposed rule Face-to-face meetings coordinated with FDA public meetings; 10 web conferences so far Key issues: definition of “farm”; exemptions based solely on size; metrics in regulation; economic impact Target: submit final comments to FDA on May 16

32. Produce Industry Activities • Produce industry has been aggressively addressing food safety, even without this law • Collaboration with government, academia, researchers • Guidance to industry • Harmonization of food safety standards • Education and outreach • Research

33. Industry Commodity Specific Guidances

34. Harmonization of Standards • Produce GAPs Harmonization Initiative • Broad industry, stakeholder involvement to adopt a single food safety standard for Good Agricultural Practices audits in the U.S. • To be used by all GAP audit schemes (e.g., GlobalG.A.P, SQF, USDA)

35. Education and Outreach

36. Research • Center for Produce Safety • USDA Agricultural Research Service • National Institute for Food and Agriculture • Numerous university and private sector activities

37. Food Safety Modernization Act: Impact on Retail Questions? David Gombas: dgombas@unitedfresh.org