FDA Produce Rule 101 WSDA Produce Safety Program Jill Wisehart, MEd
Outline • What is FSMA? • FDA Produce Rule Background • 5 Key Parts of FDA Produce • Small Farm Exemptions • WSDA Produce Safety Program/Legislative Updates • Training
Produce Safety Produce Safety Preventive Preventive Sanitary Produce Safety Rule Rule Controls for Controls for Transportation Rule Human Food Human Food of Food Accredited Third Sanitary Accredited Preventive Foreign Supplier Party Transportation Intentional Third Party Controls for Verification Certification of Human and Adulteration of Certification Animal Food Programs Rule Animal Food Food Rule
FDA Focused on Prevention over Response 48 million sick 128,000 hospitalized 3,000 die year http://www.chicagotribune.com/business/ct-biz-bright-farms-recall-20171023-story.html
First Federal Rule for Produce Farms 2015 Produce Rule 1938 Federal Food, Drug, and Cosmetic Act Adulterated Food - Impure, unsafe, unwholesome or otherwise unfit for human consumption
FDA Farm Definition Primary Production Farm Secondary Production Farm Under one management A majority interest owned, or jointed One general location owned, by primary Grow crops, harvest production farm(s) that crops and/or raise grow, harvest and/or animals raise the majority of raw Included activities produce Pack Harvest, pack and/or Hold hold raw produce Label Dry/dehydrate Different location than Treat to reduce ripening primary farm
FDA Farm Definition & Covered Activities grow harvest pack hold • store food • cool • sort • fumigate • field core • cull • dry/dehydrate • filter • grade • break down • gather • label • hull • weigh pallets • distribution • remove stems/husks • coat with • shell wax/oil/resin • sift • thresh • trim outer leaves • wash (intact produce)
Covered Produce Fruits or vegetables, including mushrooms, sprouts, peanuts, tree nuts, and herbs Not including food grains (ex: barley, corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, oilseeds)
Excluded Produce Personal or on-farm consumption Commercial processing [provided method and documentation as per § 112.(b)(2) – (b)(6)] Foods rarely consumed raw (exhaustive list): asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
How to prevent foodborne illness? 1. Keep pathogens off the food 2. Keep pathogens from spreading 3. Keep pathogens from growing https://www.researchgate.net/figure/275949688_fig6_Fig-14-Bacteria- from-the-faeces-of-wild-animals-may-contaminate-spinach-leaves-by
Humans Animals 5 Key Parts Produce Tools Compost Water * Excluding sprouts
#1 Humans (Subpart D: Worker Health, Hygiene and Training) Train employees in food safety practices adequate to farm duties RECORD = Training time, personnel, topics
#2 Animals (Subpart I: Domestic & Wild Animals) Monitor animal activity for contact with produce. Produce contaminated or damaged by animals cannot be harvested and sold. RECORD = Monitoring and corrective actions
#3 Compost (Subpart F: Biological Soil Amendments) Recommend time interval between raw manure and animal byproduct application and harvest. RECORD = Compost application type, timing and method
#4 Water (Subpart E: Agricultural Water) Agricultural Water: used in covered activities on covered produce that is intended to or likely to contact covered produce or food contact surfaces 1. Inspect all agricultural water sources at least once annually 2. Test production and post-harvest agricultural water for generic E.coli RECORD = Water Monitoring; Test Results; Corrective Actions
Ag Water Standards Post-Harvest Water Production Water Produce washing Irrigation Food contact surfaces Fertigation Crop sprays Cooling/Hydrating Cooling Hand washing Frost protection Treated agricultural tea Dust abatement Irrigating sprouts Geometric Mean (GM): Standard ≤ 126 CFU generic E. coli / 100 mL H 2 O Zero detectable E. coli in 100 mL of agricultural water Standard Deviation (STV): ≤ 410 CFU generic E. coli / 100 mL H 2 O
#5 Tools (Subpart L: Equipment Tools, Buildings & Sanitation) Clean and sanitize equipment adequate for use. RECORD = Cleaning and sanitation schedules
Is your farm “covered” by FSMA?
Small Farm Exemptions Exempt Qualified Exempt < $500,000 average annual food sales ≤ $25,000 average (in previous 3 years) annual produce sales (in previous 3 years) and A majority (by value) sold directly to “qualified end - users” [112.3(c)]: Consumer (not a business) Restaurant or retail food establishment: • in the same state or reservation, or • within 275 miles of farm
Qualified Exempt Requirements Records claiming status (EFFECTIVE NOW) 1) • Sales records including farm info, product, date and buyer • Annual review with signature and date from farm manager 2) Food packaging label (by 2020) • Farm name • Complete business address where food grown • Displayed “prominently and conspicuously” on label, poster, sign, placard, documents or electronic invoice
FDA’s Compliance Timeline Business Size Sprouts Most Produce Water Qualified Qualified Compliance Compliance Compliance Exemption Exemption (based on annual Dates Dates Dates Labeling Record produce sales) Compliance Retention Date Compliance Date All other businesses 1/26/17 1/26/18 1/26/22 (>$500K) Small businesses 1/26/18 1/28/19 1/26/23 1/1/20 1/26/16 (>$250-500K) Very small businesses 1/26/19 1/27/20 1/26/24 (>$25-250K)
Update: Agricultural Water Requirements • Update as of Sept. 2017: – FDA extending compliance dates 2-4 years (Jan. 2022, Jan. 2024)- see handout – 8 additional water testing methods from EPA- see handout
WSDA Produce Safety Program 5-year FDA grant to implement Produce Safety Rule in WA. 4 FTEs; 3 based in Olympia, 1 based in Seattle Self-assessment & Strategic Planning Mission Statement: Implement the Produce Safety Program within the 5-yr FDA grant period in order to ensure the safety and economic vitality of Washington produce.
Timeline: 2017 & Beyond • Now - May 2018: WSDA seeking state authority to conduct inspections • January – December 2018: WSDA conducting “On Farm Readiness Reviews” • Summer - Fall 2018: WSDA hiring and training produce inspectors • January 2019: official start of FDA-required inspections • March - June 2019: joint WSDA/FDA produce inspections
Produce Rule Training Requirement At least one supervisor or responsible party for your farm must successfully complete a food safety training recognized as adequate by the FDA Next PSA Grower Workshop: Dec. 9 th at Viva Farms in Mt. Vernon
PSA: Grower & Train-the-Trainer Courses Grower Course: Train-the-Trainer Course: – Taught by Produce Safety Alliance – Taught by Produce Safety Alliance certified trainers certified lead trainers – ~7 hours of instruction time – 2-day course that includes Grower covering all parts of the PSR curriculum, principles of adult education, developing partnerships, – Attendees receive certificate to verify trainer expectations, etc. required course completion – Attendees receive certificate to verify – Attendance cost varies required course completion as well as option to apply for Lead Trainer status – Attendance cost varies
On Farm Readiness Reviews (OFRR)
Group Discussion: Biggest vs Smallest Concerns A. Training Workers B. Keeping Animals Off Produce C. Water Source & Quality D. Compost Type & Application E. Equipment Cleaning & Sanitation F. Harvest & Post-Harvest Practices
Questions? Jill Wisehart, MEd Management Analyst jwisehart@agr.wa.gov (360) 902 - 1930
Resources • PSA Records: https://producesafetyalliance.cornell.edu/sites/producesafetyalliance. cornell.edu/files/shared/documents/Records-Required-by-the-FSMA- PSR.pdf • Water Testing Method Alternatives: https://www.fda.gov/downloads/Food/FoodScienceResearch/Laborat oryMethods/UCM575255.pdf • Coverage & Exemption Flowchart: https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/U CM472499.pdf • Compliance Dates: https://producesafetyalliance.cornell.edu/food- safety-modernization-act/produce-safety-rule-compliance-dates- timeline (chart version)
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