FDA Produce Rule 101. WSDA Produce Safety Program. Jill Wisehart, MEd

Transcription

1 FDA Produce Rule 101 WSDA Produce Safety Program Jill Wisehart, MEd

2 Outline What is FSMA? FDA Produce Rule Background 5 Key Parts of FDA Produce Small Farm Exemptions WSDA Produce Safety Program/Legislative Updates Training

3 Produce Produce Safety Safety Rule Rule Preventive Controls for Human Food Sanitary Transportation of Food Preventive Controls for Animal Food Foreign Supplier Verification Programs Sanitary Transportation Intentional Adulteration of Human and of Animal Food Food Accredited Third Accredited Party Third Party Certification Certification Rule Rule

4 FDA Focused on Prevention over Response 48 million sick 128,000 hospitalized 3,000 die year

5 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

6 FDA Farm Definition Primary Production Farm Under one management One general location Grow crops, harvest crops and/or raise animals Included activities Pack Hold Label Dry/dehydrate Treat to reduce ripening Secondary Production Farm A majority interest owned, or jointed owned, by primary production farm(s) that grow, harvest and/or raise the majority of raw produce Harvest, pack and/or hold raw produce Different location than primary farm

7 FDA Farm Definition & Covered Activities grow harvest pack hold cool field core filter gather hull remove stems/husks shell sift thresh trim outer leaves wash (intact produce) sort cull grade label weigh coat with wax/oil/resin store food fumigate dry/dehydrate break down pallets distribution

8 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)

9 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

10 How to prevent foodborne illness? 1. Keep pathogens off the food 2. Keep pathogens from spreading 3. Keep pathogens from growing

11 5 Key Parts Humans Animals Produce Tools Compost Water * Excluding sprouts

12 #1 Humans (Subpart D: Worker Health, Hygiene and Training) Train employees in food safety practices adequate to farm duties RECORD = Training time, personnel, topics

13 #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

14 #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

15 #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

16 Standard Ag Water Standards Production Water Irrigation Fertigation Crop sprays Cooling Frost protection Dust abatement Post-Harvest Water Produce washing Food contact surfaces Cooling/Hydrating Hand washing Treated agricultural tea Irrigating sprouts Geometric Mean (GM): 126 CFU generic E. coli / 100 ml H 2 O Standard Deviation (STV): 410 CFU generic E. coli / 100 ml H 2 O Zero detectable E. coli in 100 ml of agricultural water

17 #5 Tools (Subpart L: Equipment Tools, Buildings & Sanitation) Clean and sanitize equipment adequate for use. RECORD = Cleaning and sanitation schedules

18 Is your farm covered by FSMA?

19 Small Farm Exemptions Exempt $25,000 average annual produce sales (in previous 3 years) Qualified Exempt < $500,000 average annual food 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

20 Qualified Exempt Requirements 1) Records claiming status (EFFECTIVE NOW) 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

21 Business Size (based on annual produce sales) All other businesses (>$500K) FDA s Compliance Timeline Sprouts Compliance Dates Most Produce Compliance Dates Water Compliance Dates 1/26/17 1/26/18 1/26/22 Qualified Exemption Labeling Compliance Date Qualified Exemption Record Retention Compliance Date Small businesses (>$ K) Very small businesses (>$25-250K) 1/26/18 1/28/19 1/26/23 1/26/19 1/27/20 1/26/24 1/1/20 1/26/16

22 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

23 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.

24 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

25 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

26 PSA: Grower & Train-the-Trainer Courses Grower Course: Taught by Produce Safety Alliance certified trainers ~7 hours of instruction time covering all parts of the PSR Attendees receive certificate to verify required course completion Attendance cost varies Train-the-Trainer Course: Taught by Produce Safety Alliance certified lead trainers 2-day course that includes Grower curriculum, principles of adult education, developing partnerships, trainer expectations, etc. Attendees receive certificate to verify required course completion as well as option to apply for Lead Trainer status Attendance cost varies

27 On Farm Readiness Reviews (OFRR)

28 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

29 Questions? Jill Wisehart, MEd Management Analyst (360)

30 Resources PSA Records: cornell.edu/files/shared/documents/records-required-by-the-fsma- PSR.pdf Water Testing Method Alternatives: orymethods/ucm pdf Coverage & Exemption Flowchart: CM pdf Compliance Dates: (chart version)