1. California Grocers Association and United Fresh Produce Association
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 Confidence Increase 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
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: