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Produce Safety Alliance Annual Trainers & Lead Trainers Update October 31, 2018 Agenda Welcome & Introduction of the PSA PSA Milestones & Training Capacity Important FDA Guidance Documents & Announcements New and


  1. Produce Safety Alliance Annual Trainers & Lead Trainers Update October 31, 2018

  2. Agenda  Welcome & Introduction of the PSA  PSA Milestones & Training Capacity  Important FDA Guidance Documents & Announcements  New and Updated PSA Educational Materials  Online Course Update, Social Media, & Communications  PSA Policies & Reminders  2019 Plans & Goals

  3. Northeast: Produce Safety Alliance Team Betsy Bihn, Ph.D. Gretchen Wall, M.S. Midwest: Laura Acuña-Maldonado, Ph.D. Northwest: Don Stoeckel, Ph.D. Michele Humiston Connie Fisk, Ph.D. Rob Way Southwest: Donna Clements, M.S. Southeast: Kristin Woods, Ph.D.

  4. 2018 Milestones • 3 National Soil Summits (2 in 2017, 1 in 2018) • 1 National Water Summit (Feb. 2018) • Advanced trainer course at UC Davis (May 2018) • Release of PSA Version 1.1 Grower Training Manual (Dec. 2017), Spanish (July 2018) • New educational materials and factsheets • Training reports • International efforts 4

  5. PSA by the Numbers • Reports conducted quarterly • Next report available January 2019 • Full reports available on the website: https://producesafetyalliance.cornell.edu/training/training-reports • Most recent report captures data from September 2016 (launch of programs) until September 19, 2018 5 5

  6. PSA Training Milestones Overall Stats Sept. 2016 – Sept. 2018 27,228 Grower Training Participants 2,207 Train-the-Trainer Participants Train-the-Trainer Courses Grower Training Courses Domestic Domestic • 58 Train-the-Trainer Courses • 815 Grower Training Courses • 1,562 Trainers • 18,893 Grower Participants • 209 Lead Trainers International International • 12 Train-the-Trainer Courses • 335 Grower Training Courses • 503 Trainers • 8,335 Grower Participants • 32 Lead Trainers 6

  7. WY: 1

  8. Regional Trainer Distribution 9 9

  9. PSA Courses by Region 10 10

  10. International Efforts • Partnership with JIFSAN - Produce International Partnership for Education & Outreach (PIP) • Since 2017, 12 international TTT courses hosted, 8 through the PIP • Working with the PIP to address language and financial barriers to international trainers becoming Lead Trainers • New Trainers-of-Trainers (ToTs) approved with Spanish proficiency for conducting international courses • More info at: https://international.jifsan.umd.edu/catalogue/course/pip 11

  11. International Courses Country Grower Courses GT Participants TTT Courses TTT Participants Argentina 11 200 0 0 Brazil 1 49 0 0 Canada 3 27 0 0 Chile 98 2676 0 0 Colombia 4 74 1 50 Costa Rica 21 401 1 0 Dominican Republic 5 27 1 34 Ecuador 28 551 1 29 Guatemala 9 333 1 33 Honduras 0 0 1 39 Jamaica 0 0 1 43 Mexico 130 3365 4 (2) 218 Morocco 1 6 0 0 Nicaragua 1 26 0 0 Peru 20 560 1 45 Spain 1 10 0 0 Uruguay 2 30 0 0 Totals 335 8335 12 491 Note: 28 courses International GT courses and 1 TTT course currently do not have participant data, most of which were hosted between June - September 2018. Course data still yet to be returned by 12 host or currently being entered into the AFDO database.

  12. Country # of Trainers # of Lead Trainers International Trainers Antigua and Barbuda 1 0 Argentina 1 1 Barbados 3 0 & Lead Trainers Canada 4 0 Chile 8 5 China 0 1 Colombia 48 0 Top 3 Countries with Trainers: Costa Rica 12 3 Dominica 1 0 1. Mexico (208) Dominican Republic 34 0 2. Peru (49) Ecuador 23 3 3. Colombia (48) El Salvador 1 0 Germany 0 1 Guatemala 26 0 Top 3 Countries with Lead Trainers: Haiti 1 0 Honduras 35 1 1. Mexico (14) Italy 2 2 2. Chile (5) Jamaica 26 0 Korea 1 0 3. Costa Rica/Ecuador (3) Mexico 208 14 Netherlands 1 0 Panama 3 0 Peru 49 0 St. Vincent & Grenadines 1 0 Saudi Arabia 1 0 Spain 0 1 Thailand 1 0 Trinidad & Tobago 9 0 United Kingdom 1 0 Uruguay 1 0 Vietnam 1 0 Total International 503 32 13

  13. Building PSA Training Capacity • Co-training and mentoring opportunities • Expanded access to funding for LT development through CAP funds • Partnerships with State Departments of Agriculture & Health • Connect states to existing resources/people and help identify and address critical resources to address diversity of growers and farming practices in their region/state • Produce International partnership (PIP) focusing on international training needs, especially for countries which export large quantities of produce to the U.S. 14

  14. FDA Updates/Announcements • Draft PSR Guidance (NEW! 10/19/18) • Small entities compliance guide • Enforcement discretion/farm inspections • Updates to facilities registration guidance • Inflation adjusted cut-offs • Status of agricultural water and compliance date extension • Equivalent methods for water testing • Other specific FDA fact sheets 15

  15. Draft Guidance Published • Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption • Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry – Published in Federal Register on October 22, 2018 – Comments can be submitted until Apr. 22, 2019 – PSA planning to host Educator’s call in early December 2018 to discuss the draft guidance 16

  16. Small Entities Compliance Guide Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability • Released September 2017 • Restates much of Rule in a format that may be easier to understand • Included in 1.1 versions of the PSA Manual 17

  17. Enforcement Discretion Trainers should be aware of enforcement discretion: • Farm and facility definitions. When facilities conduct farm activities, that otherwise would not be subject to CGMPs, enforcement discretion for PC-HF Rule requirements • Written assurances related to kill steps • Other important announcements: – No routine inspections until Spring 2019 – No enforcement of Subpart E (water) while rulemaking for extension to compliance date is underway 18

  18. Farm Inspections Tour • FDA release June 2018 – Virtual produce tour video 19

  19. Status as a Qualified Facility • Farm mixed-type facilities may be covered by both the Produce Safety Rule and a Preventive Controls Rule • Important guidance for facilities that fall under the definition of a Qualified Facility – A very small business based on 3-year average sales of {human or animal} food plus the market value of {human animal} food manufactured, processed, packed, or held without sale (e.g., held for a fee) OR – Majority of sales are to qualified end users, and the average value of all food sold <$500,000 (3-year average, inflation adjusted) • $1,000,000 for human food, part 117 • $2,500,000 for animal food, part 507 20

  20. FSMA Inflation Adjusted Cut Offs 21

  21. Water Compliance Date Extension • Proposed Rule by FDA, called: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E. • Applies to all provisions of Subpart E other than sprouts – Safe and sanitary agricultural water quality – Annual inspection of the agricultural water system – Numeric criteria for agricultural water used during production and postharvest – Monitoring requirements for agricultural water used during postharvest • Until the Proposed Rule is accepted and more is known, the water requirements in Module 5: Agricultural Water remain – Enforcement discretion applies in the meantime Version 9-2017 22

  22. FDA Proposed Rule: Water Compliance Dates Proposed Compliance Dates Business Size Water Related For Most Produce Compliance Dates All other businesses (>$500K) 1/26/18 1/26/22 Small businesses 1/28/19 1/26/23 (>$250K-500K) Very small businesses 1/27/20 1/26/24 (>$25K-250K) • According to the Proposed Rule issued Sept. 2017, compliance dates for all agricultural water requirements allow for an additional 4 years. • For example, ‘all other businesses’ would have until 2022 to begin taking their water samples. 23

  23. Water Compliance Date Extension: Suggestions for Growers Now • Continue water testing – To better understand water quality – To meet buyer and audit requirements • Develop water management strategies – To identify and reduce risks – Example: Surveys of water sources • Understand quality by testing … especially if they have never tested they should test – For generic E. coli – Before using agricultural water – During frequent use periods 24

  24. Equivalent Water Testing Methodologies • This FDA fact sheet was updated in 2018 to include presence/absence methods • Old version , with only quantitative methods, included in the 1.1 version of the PSA Manual – Trainers should explain and remove the old version from the manual • Different methods apply to water used different ways – Production water criteria; must use quantitative methods – Postharvest water criteria; may use either quantitative or presence/absence methods The proposed compliance dates for water rules (Subpart E except for sprouts) in the PSR are 2022 or later. Requirements may change. 25

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