FSMA Produce Safety Rule Requirements for Producers: Exempt Qualified Exempt Non-Exempt

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1 FSMA Produce Safety Rule Requirements for Producers: Exempt Qualified Exempt Non-Exempt Joe Hannan, MS Angela Shaw, PhD Catherine Strohbehn, PhD, RD, CP-FS Linda Naeve, MS Objectives of session What is the produce safety rule? What is a farm Are you Exempt Qualified exempt Full compliance What requirements must exempt and qualified exempt meet? The Food Safety Modernization Act (FSMA) Signed into law on January 4, 2011 Focused on prevention of food safety issues Encompasses the entire food system From: Produce Safety Alliance 1

2 The Food Safety Modernization Act (FSMA) FSMA includes: Produce Safety Rule Preventive Controls for Human Food Preventive Controls for Animal Food Foreign Supplier Verification Programs Accreditation of Third-Party Auditors/Certification Bodies Sanitary Transportation of Human and Animal Food Prevention of Intentional Contamination/Adulteration Sept. 17, 2015: Current GMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food Sept. 17, 2015: Current GMP and Hazard Analysis and Risk-Based Preventive Controls for Animal Food Oct. 31, 2015: Produce Safety From: Produce Safety Alliance Produce Safety Rule First ever mandatory federal standard for growing, harvesting, packing, and holding of fresh produce Produce Safety Rule Science-based minimum standards for the safe growing, harvesting, packing, and holding of covered fruits and vegetables grown for human consumption on a farm 2

3 Outbreaks Associated with Produce Produce Safety Rule Ultimately, all growers should understand and take action to reduce food safety risks on the farm Asparagus Beans Beets Sour cherries Sweet corn Potato Sweet Potato Pumpkin Winter Squash Dill Peanuts Okra Lentils 3

4 Primary Production Farm One operation In one general vicinity May be multiple tracts of land Primary Production Farm might Pack or store raw agricultural commodities You may process food for your own consumption Can, freeze Primary Production Farm could You can dry/dehydrate produce for sale You can also make raisins Primary Production Farm could You can gas tomatoes Kind of defeats the purpose of fresh, vine ripened local tomato in Iowa. You can gas apples and bananas 4

5 Recap Primary Production Farm One operation, one management, one general location Grow, harvest, pack raw fruits and vegetables off farm use Raise animal foods used off farm Manufacture or process foods for on farm use under same management Manufacture or process foods off farm use if restricted processing Examples: Grow and sell fresh strawberries to local school Farmer grows and packs apples Wholesale tomato farmer sells seconds to livestock producer Second Activities Farm A group of farmers can share a packing shed / cold storage Farmers must own majority of packing shed Examples Ocean Spray Now defunct apple coops in Western IA Some produce auctions are member owned Potato groups in SE IA Aronia custom harvest and storage 5

6 Mixed-Type Facility Some activities = Exempt + Some activities = Not exempt Examples: You sell tomatoes to Hy-Vee = exempt + You sell cucumbers to Capital City Produce = Non Exempt Sorry but you are not exempt Sorry but you are not exempt Examples: You sell Tomatoes to Hy-Vee = exempt + You sell Potatoes to Capital City Produce = Exempt PRODUCE SAFETY RULE EXEMPTIONS Yes! You are exempt Unless you are over $500,000 6

7 Exempt You do not have to comply with the rule Examples of Exempt Farms Example from participants But Our examples You still must grow safe food Exemption can be removed Tester s Act Exceptions Qualified facilities 3 previous years sold majority of their food directly to qualified endusers and have an average yearly value of the food sold of less than $500,000 QUALIFIED EXEMPT 7

8 Tester s Act Exceptions Qualified end-users Consumers Restaurants retail food establishments that sell directly to consumers and are located in the same state as the qualified facilities or located no further than 275 miles from them If you are a Qualified Exemption then General Requirement (Subpart B) Records (Subpart O) Compliance and Enforcement (Subpart Q) Withdrawal of Qualified Exemption (Subpart R) Food packaging labels Subpart B General Requirements You are not exempt from liability You must grow safe produce Subpart R Withdrawal from Exemption If you screw up! 8

9 Subpart O Records records that show the farm is below the sales threshold selling more to qualified end users than not and that the purchaser is a qualified end user Subpart Q Compliance and Enforcement FDA Inspections Iowa farms can/will be inspected by FDA Review annually Food Packaging Labels Food Packaging Labels Name Complete address One of the following On produce On produce package On invoice On Farm market stand Name Complete address But also the original grower One of the following On produce On produce package On invoice On Farm market stand At time of sale. At time of sale. 9

10 Compliance dates based on size of farms FULL COMPLIANCE Definitions Very small business Average sale of produce sold during previous 3 years of no more than $250,000 Small business -- Average sale of produce sold during previous 3 years of no more than $500,000 Compliance Dates based on size of farm Size of Covered Farm Covered activities involving sprouts Covered activities involving all other covered produce: Water Covered activities involving all other covered produce: All other Qualified Exempt: Retention of Records Qualified Exempt: Modified( (b)(1) Qualified Exempt: All other (112.6 and 7) Very Small 3 years 6 years 4 years Now 1/1/ years Small 2 years 5 years 3 years Now 1/1/ years All other 1 years 4 years 2 years Now 1/1/2020 N/A Requirements Required Produce Safety Alliance Course New water testing Record keeping Inspection GAPs plan is a great start! 10

11 Our Role Free on-farm compliance help Visit us at our the Food Safety Booth CLARITY Yes there are issues Details of the rule are still being finalized A lot of we don t know yet answers You can wash produce Chlorine tsunami You can add labels You can pick, trim, pack store 11

12 You can bulk pick apples and move to your packing shed for further grading and fine packing You can use a refer truck in the field to cool and then transport to packing shed and permanent cooler You can direct pick into plastic clamshells or bags Add a label Sell to qualified farm You can field trim roots, leaves, husks Radish roots Sweet corn shank Carrot tops Sales from my on-farm manufacturing operation that are made via mail, catalog or Internet order, or through online farmers markets or online grocery delivery are considered sales of food directly to consumers Iowa Food Coop Iowa Valley 12

13 Seconds or unsold produce fed to animals must be treated like human food Maple syrup producers that gather sap from sugar maple trees is a harvesting under farm definition Maple syrup producers that concentrating the sap through the application of heat to make syrup is a form of manufacturing/ processing earlier as example? Extracted and bottled honey produced on a farm (i.e., remove the wax seal and spin the honey out of the honeycomb, then bottle the honey) Extracting honey is considered harvesting Bottling honey is packaging a RAC, which is a type of manufacturing/processing included within the farm definition. A business that is not owned by farmers, and not located on a primary production farm, that collects honeycombs or honey from multiple farms, packs it (e.g., in 10-gallon containers), and sends it to a processing facility This is a packing facility and does not meet the definition of a secondary activities farm SO SO tell how fits? Does size of container matter? 13

14 Questions Angela Shaw Visit our website: Follow us on Facebook and Twitter NCR FSMA Training, Extension, and Technical Assistance Questions Angela Shaw Visit our website: Follow us on Facebook and Twitter NCR FSMA Training, Extension, and Technical Assistance 14