Produce Safety AllianceAnnual Trainers &

Lead Trainers Update

October 31, 2018

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

Southwest: Donna Clements, M.S.

Midwest: Don Stoeckel, Ph.D.

Northeast: Betsy Bihn, Ph.D.

Gretchen Wall, M.S.Laura Acuña-Maldonado, Ph.D.

Michele HumistonRob Way

Southeast: Kristin Woods, Ph.D.

Northwest: Connie Fisk, Ph.D.

Produce Safety Alliance Team

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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

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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

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PSA Training Milestones

Domestic• 815 Grower Training Courses • 18,893 Grower Participants

Domestic • 58 Train-the-Trainer Courses • 1,562 Trainers • 209 Lead Trainers

International • 12 Train-the-Trainer Courses• 503 Trainers• 32 Lead Trainers

International• 335 Grower Training Courses• 8,335 Grower Participants

Overall StatsSept. 2016 – Sept. 2018

27,228 Grower Training Participants2,207 Train-the-Trainer Participants

Train-the-Trainer Courses Grower Training Courses

WY: 1

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Regional Trainer Distribution

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PSA Courses by Region

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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

International Courses

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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 host or currently being entered into the AFDO database.

Country Grower Courses GT Participants TTT Courses TTT ParticipantsArgentina 11 200 0 0Brazil 1 49 0 0Canada 3 27 0 0Chile 98 2676 0 0Colombia 4 74 1 50Costa Rica 21 401 1 0Dominican Republic 5 27 1 34Ecuador 28 551 1 29Guatemala 9 333 1 33Honduras 0 0 1 39Jamaica 0 0 1 43Mexico 130 3365 4 (2) 218Morocco 1 6 0 0Nicaragua 1 26 0 0Peru 20 560 1 45Spain 1 10 0 0Uruguay 2 30 0 0Totals 335 8335 12 491

International Trainers & Lead Trainers

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

Top 3 Countries with Trainers:1. Mexico (208)2. Peru (49)3. Colombia (48)

Top 3 Countries with Lead Trainers:1. Mexico (14)2. Chile (5)3. Costa Rica/Ecuador (3)

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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.

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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

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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

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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

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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

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Farm Inspections Tour• FDA release June 2018

– Virtual produce tour video

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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

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FSMA Inflation Adjusted Cut Offs

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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

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Business Size Compliance DatesFor Most Produce

Proposed Water Related

Compliance Dates

All other businesses (>$500K) 1/26/18 1/26/22

Small businesses (>$250K-500K) 1/28/19 1/26/23

Very small businesses (>$25K-250K) 1/27/20 1/26/24

FDA Proposed Rule: Water Compliance Dates

• 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.

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• 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

Water Compliance Date Extension:Suggestions for Growers Now

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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.

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FDA Fact Sheet: Equivalent Water Testing Methodologies (Quantitative)

Cited method in FDA Fact Sheet

Shorthand method name

EPA Method 1603 Modified mTEC agarEPA Method 1103.1, Standard Methods 9213 D, ASTM method D5392-93

mTEC agar

EPA Method 1604 MI agarStandard Methods 9222 B followed by 9222 G

m-Endo followed by NA-MUG agar

Hach method 10029 m-ColiBlue 24 ampules

Product/medium named in FDA Fact Sheet

Method notes

IDEXX Colilert test kit, only if using Quanti-Tray/2000

IDEXX Colilert-18 test kit, only if using Quanti-Tray/2000

Most probable number methods (quantitative)

Prod

uctio

n or

Pos

thar

vest

Wat

er

Membrane filtration methods (quantitative)

There are several formats for Colilert, be sure the lab uses the FDA-named quantitative format. One reference protocol for this product is Standard Methods 9223B.

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FDA Fact Sheet: Equivalent Water Testing Methodologies (Presence/Absence)

Product/medium named in FDA Fact Sheet

Manufacturer/source

TECTATM EC/TC medium and instrument

Veolia Water Technologies

Modified Colitag, ATP D05-0035

CPI International

IDEXX Colilert test kit IDEXX Laboratories, Inc.IDEXX Colilert-18 test kit IDEXX Laboratories, Inc.IDEXX Colisure test kit IDEXX Laboratories, Inc.E*Colite Bag or Vial test Charm SciencesReadycult Coliforms 100 EMD Millipore, catalog 101298

Post

harv

est W

ater

Onl

y

Presence/absence methods (in 100 mL)

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Rarely Consumed Raw• Included in the 1.1 version of the PSA Manual• Saves trainers from explaining the FDA’s process

– For example, sweet potato is rarely consumed raw but yams are not because not enough people reported eating yams raw

– Another example, taro is toxic if eaten raw but it is not on the list for the same reason

• Process for addressing these issues used by Hawaii Dept. Agriculture

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Biological Soil Amendments

• Fact Sheet released by FDA in 2018– This document explains the main issues both in the

language of the Rule and in plain English– The fact sheet can save a lot of time explaining the

definitions and time-to-harvest requirements

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New PSA Resources & Materials

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New PSA Resources & Materials

• Supplemental fact sheets and teaching add-ons– UPDATED Post-harvest Sanitizer Tool (Excel), plus NEW factsheet– Coliform activity NEW– Cleaning & Sanitation Activity (Photos)– Required PSR records (Word template)– Exemptions & Exclusions (PPT)– New videos…and more to come!– Addition of Spanish language documents

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• Water continues to be a big issue resulting in many questions from stakeholders, so PSA team has focused attention here

• PSA materials to address consistency and accuracy in training Supplemental Slides: Updates on Agricultural Water Supplemental Activity: Is This Agricultural Water? Fact sheet: The Water Analysis Method requirements in the PSR

• Webinar: How to Create a Water Lab Map for Farms in Your Area PSA collaboration with Michigan State, June 22, 2018 SOP to map of water analysis labs Educational slides to communicate farm needs with labs

Agricultural Water Resources

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PSA Online Grower Training Course

• Developing remaining PSA Modules and building content within eCornell platform

• Working towards goal of early 2019 pilot• Course will meet requirements of 112.22(c) and result in AFDO

certificate

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PSA Communications

• General Listserv – 4,296 members– Sign up on PSA website

• Educator’s Listserv – 372 members– 8 Zoom meetings hosted in 2018 with ~500 educators in attendance– Contact mmc15@cornell.edu to sign up or visit:

https://producesafetyalliance.cornell.edu/resources/educators-group/

• PSA Trainers & Lead Trainers Listserv – 2,364 members– Automatically enrolled after attending a PSA TTT– Update contact info on Trainer Directory:

https://producesafetyalliance.cornell.edu/training/directory/

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Social Media

https://www.facebook.com/ProduceSafetyAlliance

https://twitter.com/Produce_Safety

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PSA Policy Reminders• PSA Course Protocols – PSA reserves the right to conduct

course audits, revoke course registrations, or suspend trainer status if training course protocols are not met. – Training protocols are outlined in the PSA Train-the-Trainer Manual

under the Course Info and Trainer Info tabs.

• PSA Grower Training Course Evaluations must be printed, distributed to all participants, collected, and mailed directly to AFDO.– We have begun auditing the receipt of evaluations and have

implemented a tracking system. Warnings will be sent to Lead Trainersif three or more course evaluations are missing for more than 90 days. If evaluations continue to not be returned for future courses, Lead Trainer status will be suspended.

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Evaluations

• Do not edit the information in the upper right hand box of the course evaluations or reuse other course evaluations.

• Follow the evaluation printing instructions included in AFDO’s course approval e-mail. Poorly/incorrectly printed copies of evaluations cannot be processed with PSA’s evaluation scanning software.

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Printing Evaluations• Only white paper, 28 lb. thickness• 2-sided duplex printing recommended• Do not use photocopied versions• Print evals at 100% size (do not select

“fit” or “scale to fit page”• Use blue or black pen and instruct

participants to stay inside boxes

3 different printing scales

2 different paper sizes

YUCK, just yuck…

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PSA Policy Reminders• Please make sure to register courses at least 2 weeks in advance!

This provides AFDO the necessary time to generate the registration paperwork and set up the course within the database.– Retroactive registration not accepted unless all paperwork can be presented

including PSA evaluations, course documentation, and proof of PSA lead Trainer/Trainer attendance, and subject to $250 administrative fee.

• Keep AFDO up-to-date if any changes are made after the initial course registration is made (location, date, trainers, etc.). – This impacts training certificates and eligibility for ToT status.

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Updated USB Content & Trainer Directory

USB content updated on August 1, 2018• Download at:

https://producesafetyalliance.cornell.edu/training/grower-training-powerpoint-modules/

Keep your contact info up-to-date with AFDO and the PSA• https://producesafetyalliance.cornell.edu/

training/directory/• Use the ‘Update my Entry’ section

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2019 Goals

• Continue to support PSA Trainers, Lead Trainers, and those interested in becoming PSA Trainers/Lead Trainers

• Continue to support growers in both understanding PSR requirements and how to implement practices to reduce risks

• Complete and launch PSA Online Course (English and Spanish)• Develop a Spanish PSA web interface• Complete peer-reviewed publications to ensure we are

sharing data that has been generated

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Funding Updates

• PSA has received some additional funding to support us through 2020

• Funding is still a concern as needs will extend far beyond current funding

• PSA provides unique outreach and assistance that is important to growers, trainers, and the produce industry

• Sustainable PSA funding is a challenge

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Importance of the PSA

• Collaboration• Facilitating dialog and discussion• Up-to-date resources and educational

materials• Developing PSA Trainers and Lead Trainers• Updating PSA Curriculum• Providing Development Opportunities

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The PSA Website http://producesafetyalliance.cornell.edu/

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