FSPCA ANNUAL CONFERENCE. CHICAGO NAVY PIER July 18, 2018

FSPCA ANNUAL CONFERENCE CHICAGO NAVY PIER July 18, 2018

WELCOME AND OPENING REMARKS Donna Garren Executive Vice President, American Frozen Food Institute (AFFI)

July 18, 2018 Agenda WEDNESDAY, JULY 18, 2018 START END SESSION PRESENTER(S) 1:00 PM 1:10 PM Welcome and Opening Remarks Donna Garren 1:10 PM 1:40 PM Food Safety Preventive Controls Alliance (FSPCA) Human Food and FSVP Update 1:40 PM 1:55 PM Food Safety Preventive Controls Alliance (FSPCA) Animal Food Update Kathy Gombas David Fairfield 1:55 PM 2:10 PM Produce Safety Alliance (PSA) Update Don Stoeckel 2:10 PM 2:25 PM Sprout Safety Alliance (SSA) Update 2:25 PM 3:25 PM FDA Perspectives on FSMA Implementation and Inspections BREAK 3:25 3:40 PM Kaiping Deng Glenn Bass Sharon Mayl 3:40 PM 4:00 PM FDA Food Safety Plan Builder Jenny Scott 4:00 PM 5:25 PM Challenges for FSPCA Instructors Panel: Amanda Evans-Lara, Jenifer Kane, Tania Martinez, Barry Parsons, Marcos Sanchez and Juan Silva Facilitator: Matt Botos 5:25 PM 5:30 PM Day 1 Recap/ Day 2 Preparation Robert Brackett NETWORKING RECEPTION 5:30 7:00 PM 3

Housekeeping What is in your folder? Conference Agenda Bio Packet for Conference speakers, facilitators and panelists Conference Map Rules of Engagement for the Conference and specific sessions o Take special note of information on the Town Hall and Ask an Expert Sessions to get the most benefit from these sessions For purchase Wi-Fi information 4

FSPCA HUMAN FOOD AND FSVP UPDATE Kathy Gombas Co-Chair, FSPCA International Subcommittee and ToT Work Group

FSPCA Participant Course Metrics FSPCA Participant Certificates Issued Human Food Animal Food FSVP Domestic 43,641 5,895 3,583 International 24,563 397 494 Total 68,204 6,292 4,077 FSPCA Participant Courses Registered Human Food Animal Food FSVP 5,788 470 570 July 2018 6

Human Food Blended Course HUMAN FOOD BLENDED Total Enrollments 1297 (116 Int l) Completed Part 1 1,133 (87%) Completed Part 2 969 (86%) Part 2 Courses Registered Part 2 Courses Completed 254 136 July 2018 7

Lead Instructors Human Food LIs 1,569 (499 international) Human Food LI Candidates 871 Human Food LI Courses Completed Animal Food LIs 54 230 (18 international) Animal Food LI Candidates 329 Animal Food LI Courses Completed FSVP LIs 8 248 (37 international) FSVP LI Candidates 225 FSVP LI Courses Completed 11 As of July 2018 8

FSPCA Development Projects Current Animal Food Blended Course Intentional Adulteration (IA) On-line Courses Food Defense Awareness (available now) IA Rule Overview (available now) Key Activity Types Identify Explain Mitigation Strategies Food Defense Plan & Reanalysis IA Instructor-led Vulnerability Assessment course Future (potential) Animal Food CGMP FSVP Online Course 9

FSPCA International Subcommittee Goal Increase PCQI training to industry worldwide through increasing pool of Lead Instructors via outreach efforts Education / Outreach Campaign What it means to become a Lead Instructor (LI) and teach courses Encouragement Campaign Encourage current LIs to offer courses Reach out to existing international LIs to encourage them to teach PCQI courses 10

Active Countries Participant Courses Offered Country Certificates Number of courses delivered Mexico 3996 292 Italy 2240 241 China 2186 104 Canada 1470 151 Thailand 1136 76 Spain 1133 95 Japan 1002 83 Colombia 906 49 Chile 849 55 India 847 59 Peru 720 46 For HF, AF, and FSVP As of May 24, 2018 11

International FSPCA Interagency Training Initiatives Back-to-Back PCHF Participant and Lead Instructor courses East Africa & West Africa (funded by USAID via USDA/FAS) Using FAS French translated materials East Africa completed March 2018 West Africa week of August 20, 2018 Latin America, (funded by FDA via IICA Agreement) Deliver in Spanish using S2 translated materials Mexico: August 13-17 Chile: August 20-24 Ecuador: August 27-31 South Asia (funded by USDA/FAS) Date TBD early 2019 Location in India 12

FSPCA Translation of Training Materials English and Spanish (S1) translated materials are the ONLY official PCHF versions in the Lead Instructor Resource Portal Should use official English version or other FSPCA endorsed language version of training materials, e.g. Spanish participant manual exercise workbook food safety plan teaching examples 13

FSPCA Translation of Training Materials FSPCA established translation guidelines for FSPCA training materials when an official translation is not available Translations must be reviewed by the FSPCA Educational Review Team Reviewers include FDA, translators, international government counterparts, and other implementing partners. Reviewers assess: Accuracy and consistency in FSMA terms when translated into foreign languages. Use of FSMA Key Terms Glossary when applicable. Consistency with Codex standards on General Principles of Food Hygiene document (CAC/RCP 1-1969) translations. 14

FSPCA Translation of Training Materials Availability of Translated FSPCA Training Materials After FSPCA Educational Review Team s review, the translated materials will be available to the public on the FSPCA website. Translated FSPCA training materials will be made available on the Lead Instructor Resource Portal. Manuals (Instructor and Participant) PowerPoint slides, Exercise book, Food safety plan teaching examples 15

Translated FSPCA Training Materials If there is no officially reviewed translation, Lead Instructors must: Be bilingual in English and the foreign language. Ensure the accuracy of the delivery of FSPCA training curriculum. Inform course participants that the translation is unofficial, e.g. mark materials as unofficial version. Provide course participants access to the official English materials. 16

FSPCA Lead Instructor Resources and Communications FSPCA Trainer of Trainers Work Group Develop resources for Lead Instructors Coordinate Lead Instructor communications, e.g. Webinars 17

2018 FSPCA Lead Instructor Communications: Private Chatter Groups Lead Instructor Private Chatter Groups Forum for Lead Instructors to interact, get updates and exchange information It is NOT a forum to ask rule interpretation questions How to join: Log into the FSPCA Community at https://fspca.force.com/fspca/s/ Enter your email and password for the FSPCA Community Click on More in the horizontal bar and choose Groups from the drop-down menu Choose the Lead Instructor Group(s) you wish to join from the list displayed. We have Human Food, Animal Food and FSVP Lead Instructor Groups Click on the Request Membership button Once your Lead Instructor certificate number is confirmed, you will receive notification of acceptance into the private group 18

2018 FSPCA Lead Instructor Communications: Webinars Quarterly Lead Instructor Webinars Opportunity for Lead Instructors to hear about course material updates, tips to register and advertise courses, new resource materials, frequently asked questions, international efforts PCHF: Feb 8, May 17, August 23, Nov 8, 2018 from 10-11:30 am Central PCAF: TBD FSVP: TBD Recordings and slide presentations are posted in the appropriate FSPCA Private Lead Instructor Chatter Group 19

Accessing FSPCA Instructor Resource Portal Go to https://lms.ifpti.org/ Use your existing log in for this site Use the Forgot Password? option if you cannot recall your log in information 20

What s NEW in the FSPCA Instructor Portals? (as of May 2018) Lead Instructor Course Admin Packet PDF & PPTs Intro to Materials & Teaching Tips Instructor Skills Course Admin Course Materials Model Food Safety Plan Teaching Examples (dairy coming soon) FDA guidance documents Background on U.S. Food Safety System PPT Optional Slide Sets 21

New! Optional PCHF Hazard Guidance Slide Set Optional slide set (48 slides) that explains FDA s draft Preventive Controls for Human Food (PCHF) Guidance and FDA s Food Safety Plan Builder Highlights Guidance Key Content Describes how to use Appendix 1 when conducting a hazard analysis Optional slide set can be used by Lead Instructors during their FSPCA PCHF Participant courses Slide set (PDF) available in PCHF Lead Instructor Resource Portal PDF can be shared with course participants to assist them in conducting their hazard analysis 22

Optional FSVP Module for Preventive Controls Optional slides (~35) and text (34 pages) for Lead Instructor to use Preventive Controls for Human Food Participant Course Preventive Controls for Animal Food Participant Course Intent is to familiarize foreign suppliers about what U.S. importers are required to do Foreign suppliers may be asked for information by their importers Optional FSVP Materials found in Instructor Portal FSVP Module Slides for PCHF Participant Course FSVP Module for PCHF Participant Course Instructor Guide FSVP Module for PCHF Participant Course Participant Manual 23

Human Food and FSVP Lead Instructor Courses Human Food 2018 Location Course Type Jan 23-25 Paris, France 3-Day LI Apr 9-11 Arlington, VA 2.5-Day LI Jun 12-14 Chicago, IL 2.5-Day LI Aug 13-15 Bothell, WA 2.5-Day LI Nov 13-15 St. Paul, MN 2.5-Day LI FSVP 2018 Location Course Type Apr 11-13 Arlington, VA Combination Course Aug 15-17 Bothell, WA Combination Course Oct 16-18 Chicago, IL Combination Course 24

FSPCA ANIMAL FOOD UPDATE David Fairfield Senior Vice President, National Grain and Feed Association

FSPCA Training Delivery Model Trainer of Trainers train Lead Instructors Lead Instructors train Participants Participants Domestic and International Stakeholders AF ToTs Adam Fahrenholz David Fairfield Matt Frederking Cassandra Jones Kim Koch Sonya Lambkin David Meeker Dianne Milazzo Brandi Miller Jenny Murphy Charles Stark Pat Tovey Henry Turlington 26

Animal Food Metrics Lead Instructors Domestic International Total Lead Instructors 212 18 230 Lead Instructors Approved Candidates not yet trained Lead Instructor Courses Completed 305 24 329 6 1 7 27

Animal Food Lead Instructor Courses 2018 Location Course Type May 22-24 Raleigh, NC 2.5-Day LI Aug 14-16 Chicago, IL 2.5-Day LI 28

Animal Food PCQI Courses Domestic International Courses Completed 331 42 Upcoming Registered Courses Average Number of Participants per Course 20 4 16.6 29

May 2016 June July Aug Sept Oct Nov Dec Jan. 2017 Feb Mar Apr May June July Aug Sept Oct Nov Dec Jan 2018 Feb March Apr May June Animal Food Metrics Cumulative 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 Preventive Controls for Animal Food Certificates Issued by Month Total - 6,176 International - 397 30

Animal Food Activities and Projects Updated LI/PCQI Curriculum Oct. 2017 31

Animal Food Activities and Projects Additional example food safety plans Under development Blended course 1-½ day web-based, 1-day face-to-face Anticipate launch last quarter 2018 Stand-alone CGMP web-based course In process 32

Animal Food FSPCA Steering Committee Members Adam Fahrenholz David Fairfield Jacob Fleig Cassandra Jones Dianne Milazzo Pat Tovey North Carolina State University National Grain and Feed Association Missouri Department of Agriculture Kansas State University Food and Drug Administration Pet Food Institute 33

producesafetyalliance.cornell.edu/ 2017-2018 Another Great Year for PSA Productivity July 18 th, 2018 FSPCA Annual Conference Don Stoeckel, Ph.D. Midwest Regional Extension Associate

Agenda PSA Training Programs Progress Report Collaborative Summits Soil Summits Water Summit Collaborations including On-Farm Readiness Review Educational Products producesafetyalliance.cornell.edu/ 35

PSA Training Programs

PSA Training Programs by the Numbers PSA reports out training statistics quarterly Most recent report created June 2018 Full reports available on the PSA website: producesafetyalliance.cornell. edu/training /training-reports Note: To protect the privacy of course attendees, we do not share individual participant information with anyone producesafetyalliance.cornell.edu/ 37

Recent Data Domestic-Plus-International Totals 1,052 PSA Grower Training Courses 49 States hosted PSA GT Course 24,976 Grower Participants producesafetyalliance.cornell.edu/ 38

Recent Data Domestic-Plus-International Totals 66 PSA Train-the-Trainer Courses 32 States hosted PSA TTT Course 1,940 Trainer Participants 226 Lead Trainers producesafetyalliance.cornell.edu/ 39

International Courses Note: Participant numbers for 19 of the 288 training courses that occurred are not yet included in the tabulation International Training Partners: 341 Trainers 23 Lead Trainers producesafetyalliance.cornell.edu/ 40 40

PSA Training Program Developments in 2017-2018 PSA Grower Training & Train-the-Trainer Curriculum Switched to version 1.1 of curriculum in 2018 Translated to Spanish Building Capacity Regional Extension Associates actively mentor Alliance partners to build in-state training team capabilities PSA team collaborated with UC Davis on an Advanced Training PSA Trainers enhanced abilities; prepare to become Lead Trainers June 2018 pilot; potential for expansion Process for evaluating Trainers of Trainers (ToTs) Process for reviewing additional translations underway producesafetyalliance.cornell.edu/ 41

Online Grower Training Course Goal of Fall 2018 launch Piloted Module 2 with growers, collaborators, and regulators to ensure current approach including structure, interactive components, and content review features are effective and acceptable to participants Instructor led, self paced course Focus groups and past experience drove this decision Working to ensure equivalency so participants receive an AFDO certificate of completion; meet 112.22(c) requirements producesafetyalliance.cornell.edu/ 42

Collaborative Summits to Support Dialogue and Science

Soil Summits Three have been completed: Geneva, NY March 28-29, 2017 Houston, TX December 12-13, 2017 Atlanta, GA January 21-22, 2018 Purpose: Provide clarification of FSMA PSR Subpart F requirements Inform participants of FDA risk assessment activities Provide opportunity for growers, researchers, extension educators, industry and regulatory personnel to work collaboratively to answer questions and advance understanding about soil amendment use and risks Currently finalizing summary documentation producesafetyalliance.cornell.edu/ 44

Soil Summits Process 1. Small series of focused presentations to provide foundational information in key areas 2. Breakout sessions to discuss information and develop responses, solutions, or more questions 3. Share information from across all the breakout groups to see where consensus or dissent lies 4. Contribute insights to next steps to move forward PSA-hosted Soil Summits recognized as an effective mechanism for gathering varied stakeholder input producesafetyalliance.cornell.edu/ 45

Water Summit February 27-28, 2018 FDA, other Federal Agencies, Industry, Extension, Research and FARM personnel 102 people in Covington, KY 24 Water Summit Remote Meeting Sites 243 attendees at remote sites Online attendees from U.S. States, DC, Puerto Rico, and 7 other countries Day 1 Attendance Online: 202 143 came back for some or all of Day 1 Day 2 Attendance Online: 188 45 (24%) were new registrant emails, who did not attend on Day 1 producesafetyalliance.cornell.edu/ 46

Water Summit Remote Sites Regional Center Total Number of Sites Total Participants North Central 4 23 Northeast 4 35 Western 6 62 Southern 10 123 Total 24 243 producesafetyalliance.cornell.edu/ 47

Objectives Discuss the diverse ways water is being used on farms across the country, and challenges/concerns related to current standards for water quality and testing. Discuss and develop minimum standards, practices, or approaches to identified challenges and concerns based on existing PSR requirements that control hazards. Recommend actionable next steps related to the standards, practices or approaches that address the identified challenges and concerns producesafetyalliance.cornell.edu/ 48

Summary Outcomes High-level discussion exposed widely held concerns that were common in all groups; detail will come from analysis Concerns with the science and processes Concern about the quantitative standard Method of calculating the MWQP Food safety is valued, but growers want requirements and implementation to focus on practices that are relevant General recognition of urgent need for specific assistance, guidance, and educational materials in plain language Significant desire for FDA to be more transparent about the research foundations and water developments producesafetyalliance.cornell.edu/ 49

Meeting Documentation Agenda and speaker presentations are available online at: https://producesafetyalliance.cornell.edu/water-summit Recording of the entire meeting, in chapters on YouTube Comment opportunity for those who did not attend online or in Covington was made available (Now closed) Currently working on summary documentation Working on next steps to advance the discussion producesafetyalliance.cornell.edu/ 50

Collaboration is Crucial

Collaborations Co-Chair of PIP, with JIFSAN, for International Training Frequent collaboration with Regional FSMA Centers, Indigenous Foods Agricultural Initiative, Local Food Safety Collaborative, and others PSA team contributes to On-Farm Readiness Review development and training Collaboration with State Departments of Ag and Universities to support Alliance training program and additional extension/research opportunities producesafetyalliance.cornell.edu/ 52

Educational Products

Agricultural Water Resources 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? Produce Educator s Call: August 29, 2017; FDA updates and guidance; updates of water module in PSA Grower Training 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 and Educational slides to communicate farm needs with labs producesafetyalliance.cornell.edu/ 54

Other Resources & Materials Supplemental fact sheets & teaching add-ons Cleaning & Sanitation Activity (Photos) Post-harvest Sanitizer Tool (Excel) Required PSR records (Word template) Exemptions & Exclusions (PPT) Educational Webinars Nov 02, 2017: Understanding the FSMA Produce Safety Rule for Exempt Produce Farms May 21, 2018: Shine Some Light Down that Rabbit Hole: Coverage and Exclusions in the PSA Grower Training June 25, 2018: PSA Lead Trainer Process, Lead Trainer Challenges, Improving Trainer Competencies, & Professional Development Opportunities for Produce Safety Educators producesafetyalliance.cornell.edu/ 55

PSA Priorities for 2018-2019 Secure future funding. Very important! Continue to o Ensure growers have many training opportunities o Train and mentor PSA Trainers o Create more opportunities for dialogue and sharing o Develop educational materials to support growers, trainers, and others o Expand our knowledge and capabilities: Inspector Training On Farm Readiness Reviews producesafetyalliance.cornell.edu/ 56

Northwest: Connie Fisk, Ph.D. PSA Team and Regional Extension Associates Midwest: Don Stoeckel, Ph.D. Northeast: Betsy Bihn, Ph.D. Gretchen Wall, M.S. Michele Humiston Rob Way Southwest: Donna Pahl, M.S. Southeast: Kristin Woods, Ph.D. producesafetyalliance.cornell.edu/ 57

Sprout Safety Alliance (SSA) Updates

Sprout Safety Alliance (SSA) A public-private alliance Goal - to enhance the sprout industry's understanding and implementation of best practices and the Produce Safety Rule o Develop a core curriculum o Establish training and outreach programs

SSA Training Program Date August 2016 April 2017 December 2017 February 2018 Significant Milestones Finalized 1 st Edition of Curriculum Finalized 2 nd Edition of Curriculum Finalized Online Course Launched Blended Course

SSA Blended Course Part 1- Self-led Online Course o All 12 modules Part 2- One-day In-person Classroom Training o Review of all modules, discussion focusing on five key modules and group exercises Course Name Date Location Part 2 Course 2-13-2018 Phoenix AZ (LI + Grower Combo) Part 2 Course 4-16-2018 Tampa, FL Part 2 Course 4-27-2018 Chatham, MA Part 2 Course 7-16-2018 Nashville, TN

SSA Virtual Course under Discussion Part 1- Self-led Online Course o All 12 modules Part 2- Interactive Virtual Training o o o o Live, interactive instructor-led Conducted in two 4-hour sessions Review of all modules, discussion focusing on five key modules and group exercises Focused on getting smaller growers into SSA classes

SSA Training Metrics SSA Course Held Sprout Grower Training and Lead Instructor Combo Courses 2 Lead Instructor Courses 2 Sprout Grower Training Courses 14 Sprout Grower and Lead Instructor Training Combo Blended Course 1 Sprout Grower Training Blended Courses 2

SSA Training Metrics (cont.) SSA Lead Instructors Trained SSA Lead Instructor Candidates Trained 32 SSA Lead Instructors Approved 26 International SSA Lead Instructors Approved 4 Sprout Growers Trained Sprout Companies 74 Individual Sprout Growers Trained 109 Regulators Trained Federal Regulators Trained 41 State Regulators Trained 52 International Regulators Trained 1 Sprout Retailer Trained Supermarket chain Food Safety Manager Trained 1

Video Development Proposal Funding program: NIFA- FSOP Project type: Community Outreach Project Duration: 1 year Organizations: IFSH/IIT and WVU Support from: sprout industry, UC Davis, regional centers

Video Development Proposal (cont.) Four procedures included: 1. Cleaning and sanitizing - Rotary drums; sprouting trays 2. Environmental sampling 3. Seed treatment of the two most commonly used seed types - Alfalfa; mung beans 4. SSIW sampling from different growing units - Rotary drums; mung bean bins; rack of trays

SSA Technical Assistance Network

Other Outreach Activities FSMA update through email Personal communication Webinar

For More Information SSA website: http://www.iit.edu/ifsh/sprout_safety/ Contact the SSA: sproutalliance@iit.edu (708) 563-8170

FSPCA FDA Perspective on FSMA Implementation & Inspections Glenn Bass, Deputy Director-West Office of Human and Animal Food Operations Sharon Lindan Mayl, Senior Advisor for Policy Office of Foods and Veterinary Medicine July 18, 2018 Chicago, IL

FSMA Implementation Educate Before and WHILE, We Regulate 71

FSMA Implementation 72

FSMA Implementation 73

FSMA Implementation 74

Regulator Training and Technical Assistance Key Implementation Principle: Invest in regulator training/continuing education, ongoing calibration of regulators to promote consistent inspections and decision making o FSMA Rule Readiness: Industry Best Practices o Alliance Courses with Industry o Regulator Specific Training o Technical Assistance Network / Resources 75

FSMA Implementation 76

FSMA Implementation 07/04/1776 77

FSMA Implementation 01/04/2011 78

FSMA Inspections 09/17/2018 79

FSMA Inspections RIP CFR 110 80

FY 2018 FDA Inspections FSMA Date of Issuance Planned Number of Inspections Preventive Controls in Human Food Issued December 18, 2017 Domestic (400), Foreign (100) Businesses within staggered compliance dates Foreign Supplier Verification Program Issued November 15, 2017 Importers (2275) Preventive Controls in Animal Food (Limited to CGMP) Issued October 16, 2017 Domestic (304) Sprout Inspections Issued September 15, 2017 Domestic (90), Foreign (1) Other Center directed assignments Issued throughout year(s) Inspections, Sample Collections (Product or Environmental) 81

FDA 2018 Inspections to Date Human Food Modernized GMP Comprehensive PC Planned Not Planned 3,531 400 (domestic) 100 (foreign) Accomplished* 210** 101 Animal Food CGMP 304 235 FSVP 2,275 242 Sprout Facilities 90 25 *Data as of 6/1/2018. ORA OISM. **Conducted by CSO s completing regulators course, includes On-the-Job Experience. 82

Average Number of Days in Facility Type of Inspection Full Requirements of the Preventive Controls Human Food Facilities Exempt from full requirements of the Preventive Controls Human Food CGMP of the Preventive Controls Animal Food Number of Days 4 5 Days 3-4 Days 3 Days Challenges in calculating average hours due to team inspections. 83

Preventive Controls for Animal Food Rule PC inspections delayed until FY19 to allow for guidance to issue regarding PC requirements. Routine PC inspections will not start in FY18, but CVM will issue for cause PC inspections when deemed necessary. 84

Educating Before and While We Regulate FDA Issues Warning Letters Human Food 21 CFR CGMP Regulations, History of violations from GMP requirements Animal Food 21 CFR CGMP Regulations, Misbranding Charges, Medicated Feed, and History of violations 85

Number of Registrations Scope of Work Food Facility Registration Inventory 500,000 450,000 400,000 350,000 300,000 250,000 200,000 150,000 100,000 50,000 - Pre FSMA (10/21/2012) FSMA-2012 Biennial Renewal (1/1/2013) FSMA-2014 Biennial Renewal (1/1/2015) Pre 2016 Biennial Renewal (9/30/2016) FSMA-2016 Biennial Renewal (1/31/2017) Current (2/6/2018) Domestic 166,350 40,241 66,683 95,665 67,298 94,145 Foreign 273,238 52,516 87,316 136,348 89,722 116,427 86

Lessons Learned 87

What s Next Two Tier Inspections (Pilot) Program would evaluate industry compliance with certain requirements that are centrally-managed o Initial focus: supply chain, recall programs Working through logistics of implementing the program on a small scale, so we can access the feasibility and benefits 88

What s Next? The best way to predict the FUTURE, is to CREATE it. -Peter Drucker 89

Working together, Learning together 90

FSVP Line Entries FSVP Implementation Stats as of 6/22/18: o 13 M total lines since 1 st compliance date o 9.0 M FSV (using DUNS number) o 1.4 M UNK (No DUNS number, 14.38% of FSV lines) o 2.5 M FSX (exempt) 91

FSVP Regulator Training Prerequisite: FSPCA FSVP and PC courses o Will consider PSA Produce course when compliance dates get closer. FY17: o 3 IM220 Regulator courses 96 trained including (CFSAN, DIO, OHAFO, ORA CSOs, SCSOs, and Compliance Officers) o 1 IM220T Train the Trainer for FSVP Regulator course 8 trained FY18: o 4 IM220 Regulator courses 4 course completed 151 trained (CFSAN, DIO, OHAFO, ORA CSOs, SCSOs, and Compliance Officers) July 16-19 40 Slots Additional Regulator course TBD (depends on budget) o 1 IM220T Train the Trainer Planned for FY19 6-8 slots 92

Inspection Program Initiated June 2017 Preannounced Evaluating compliance with the FSVP requirements Consistent with PC inspections for supply chain provisions 93

FSVP Inspections FY17: 285 FSVP inspections completed o No warning letters issued o 0 OAI o 179 VAI (with 174 483a forms issued) o 106 NAI FY18: Significant increase over FY17; 256 completed as of 6/22/18 o 155 VAI (with 483a forms issued) o 101 NAI 94

FSVP Significant Observations Failure to: o Develop an FSVP o Have a written hazard analysis o Establish written procedures to ensure that foods are imported only from approved foreign suppliers o Document approval of foreign supplier o Have a written evaluation of foreign supplier performance and the risk posed by the food o Document your review and assessment of another entity s evaluation of foreign supplier performance and the risk posed by the food o Document that food was produced in accordance with LACF regulations o Document determination of verification activity(ies) Incorrect entry data 95

Questions? 96

Introduction to FDA s Food Safety Plan Builder (FSPB) FSPCA Annual Meeting 2018

98 CGMP & PC Rule: Food Safety Plan Hazard analysis Preventive controls Preventive control management components Procedures for monitoring Corrective action procedures Verification procedures Supply-chain program Recall plan

99 Food Safety Plan Builder Website https://www.fda.gov/food/guidanceregulation/fsma/ucm539791.htm

10 0 Food Safety Plan Builder Free software tool designed to assist owners/operators of food facilities with the development and documentation of food safety plans (FSPs) Target audience: medium and small facilities FSP files are stored on the user s computer only FDA does not have access to these files Use of the FSPB is optional FSPs created with the tool are not automatically approved by FDA or guaranteed to comply with FDA s rules and regulations FSPB questions: email FoodSafetyPlanBuilder@fda.hhs.gov.

10 1 Downloading the FSPB Tool

10 2 Downloading the FSPB Tool (cont d)

10 3 Contents of the FSPB Facility Information Preliminary Steps Good Manufacturing Practices (GMP) & Prerequisite Programs Hazard Analysis & Preventive Controls Determination Process Preventive Controls Food Allergen Preventive Controls Sanitation Preventive Controls Supply-Chain Preventive Controls Recall Plan Reanalysis of Food Safety Plan Food Safety Plan Report Signature Recordkeeping Procedures Important Contacts Supporting Documents

10 4 Opening Screen

10 5 Creating New or Open Existing FSP

10 6 Creating a New FSP

10 7 Facility Information

10 8 Preliminary Steps

10 9 Preliminary Steps: Flow Diagram

11 0 GMPs Checklist of Regulatory Provisions

11 1 Hazard Analysis & Preventive Controls Determination

11 2 Hazard Analysis & Preventive Controls Determination (cont d)

11 3 Hazard Analysis & Preventive Controls Determination (cont d)

11 4 Process Preventive Controls

11 5 Supply-Chain Preventive Controls

11 6 Supply-Chain Reports

11 7 Recall Plan

11 8 Reanalysis of the FSP

11 9 Signature Tab

12 0 Recordkeeping Procedures

12 1 Important Contacts

12 2 Supporting Documents

12 3 Food Safety Plan All information entered into the tabs will be compiled into one comprehensive report, the Food Safety Plan For tabs containing information not required by Part 117: by default they are not exported to the FSP; however you can add them by selecting Include in Food Safety Plan

12 4 Food Safety Plan

12 5 Additional Resources Food Safety Plan Builder User Guide https://www.accessdata.fda.gov/scripts/foodsafetyplanbuilder/fo odsafetyplanbuilderuserguide_v1.0.pdf FSPB Training Videos https://www.youtube.com/playlist?list=pley4qe-uxcxb9agnwfjoglquhdz-tkqo Hazard Analysis and Risk-Based Preventive Controls for Human Food Draft Guidance for Industry https://www.fda.gov/food/guidanceregulation/guidancedocume ntsregulatoryinformation/ucm517412.htm FSMA Technical Assistance Network (TAN) https://www.fda.gov/food/guidanceregulation/fsma/ucm459719. htm

12 6 Additional Resources (cont d) Food Safety Preventive Controls Alliance (FSPCA) TAN https://www.ifsh.iit.edu/fspca/fspca-technical-assistance-network 21 CFR Part 117 (ecfr) https://www.ecfr.gov/cgi-bin/textidx?sid=0b9e1217a13ce333d5cc33e27fdb2fd1&mc=true&node=pt2 1.2.117&rgn=div5 Full text of the Final Rule https://www.federalregister.gov/documents/2015/09/17/2015-21920/current-good-manufacturing-practice-hazard-analysis-andrisk-based-preventive-controls-for-human FDA s FSMA Website https://www.fda.gov/food/guidanceregulation/fsma/

12 7 Thank you! FoodSafetyPlanBuilder@fda.hhs.gov

CHALLENGES FOR FSPCA INSTRUCTORS Matthew Botos CEO/President, ConnectFood

Rules of Engagement Panelists will introduce themselves and share their training experiences An open Q & A session will follow Please line up at the floor microphones to ask a question The session moderator will assign questions to the appropriate panelist(s) 129

The Panelists Amanda Evans-Lara Jenifer Kane Tania Martinez Barry Parsons Marcos Sanchez Juan Silva 130

DAY 1 WRAP UP Robert Brackett Institute for Food Safety and Health (IFSH) Illinois Institute of Technology (IIT)

Day 1 Wrap Up / Day 2 Preparation The Conference opens at 7:45 AM tomorrow with breakfast provided. The first session begins promptly at 8:30 AM. Please remember to turn in your Town Hall questions by 1:30 PM tomorrow. Drop your question cards into the Town Hall Drop Box located in this room. Refer to the map of Ask an Expert sessions happening during lunch tomorrow. We will be allowing 30 minutes for personal business/lunch before the sessions begin at 1:00 PM. We recommend you attend the session that is of the greatest interest to you to get the most benefit from the session. There is a lunch-only room available for those who do not wish to attend any of the Ask an Expert sessions. Our Networking Reception begins immediately and runs until 7:00 PM tonight. Come enjoy the beautiful Chicago skyline while networking with fellow food safety professionals. 132

FSPCA ANNUAL CONFERENCE CHICAGO NAVY PIER July 19, 2018

July 19, 2018 Agenda THURSDAY, JULY 19, 2018 START END SESSION PRESENTER(S) 8:30 AM 9:30 AM FSPCA Technical Assistance Network and FDA FSMA Technical Assistance Network 9:30 AM 10:15 AM Intentional Adulteration Update Jon Woody BREAK 10:15 10:30 AM Marcos Sanchez/Deborah Price 10:30 AM 11:00 AM Marketing Tips and Tactics for Promoting Courses Matt Botos / Jerry Wojtala 11:00 AM 11:55 PM Introduction of the new FSVP Module David Gombas 11:55 AM 12:00 PM Ask an Expert Session Details Claudia Coles LUNCH 12:00-1:30 PM ASK AN EXPERT: FSMA topic-specific tables, manned with an expert, throughout the room. 1:30 PM 2:30 PM FDA FSMA Guidance Overview Jenny Scott / Dianne Milazzo / Sharon Mayl 2:30 PM 2:50 PM Ask an Expert Report Out Claudia Coles 2:50 PM 3:15 PM FSPCA Town Hall Meeting FSPCA Managing Entities and Key Committee Chairs, Produce Safety Alliance Representatives and Sprout Safety Alliance Representatives BREAK 3:15 3:30 PM 3:30 PM 4:50 PM FSPCA Town Hall Meeting (continued) FSPCA Managing Entities and Key Committee Chairs, Produce Safety Alliance Representatives and Sprout Safety Alliance Representatives 4:50 PM 5:00 PM Closing Remarks Robert Brackett / Jason Wan ADJOURN 134

FSPCA TECHNICAL ASSISTANCE NETWORK (TAN) Marcos Sanchez Associate Professor, Texas Tech University

FSPCA Technical Assistance Network (TAN) Launched FSPCA TAN in May 2016 Provides technical assistance to industry, academia and others regarding training and scientific/technical questions related to FDA s Preventive Controls human food and animal food regulations, Foreign Supplier Verification Programs, Intentional Adulteration and FSPCA Lead Instructor related issues (public listing, PCQI course edits, etc.) 136

How to contact the FSPCA TAN FSPCA TAN Webpage: https://www.ifsh.iit.edu/fspca/fspcatechnical-assistance-network Click on Submit an Inquiry Online Direct link to the online inquiry form: https://fspca.force.com/fspca/s/contactsupport?language= en_us Inquiries may be mailed to the following address if internet is not available: FSPCA TAN: 6502 South Archer Road, Bedford Park, IL 60501 137

Online Inquiry Form 138

Online Form Auto Response 139

FSPCA TAN Inquiry Response Process Inquiry Submitted Auto Response With Case # Sent to User Who Submitted the Inquiry Food Safety Resource Team Members are Notified Food Safety Resource Team Members Collaborate on Case Food Safety Resource Team Lead Drafts a Case Response Case Response Approved by TAN Administrator Case Response Sent to User who Submitted the Inquiry Case Closed 140

Food Safety Resource Team Members (FSRTs) Inquiries submitted to the FSPCA TAN are routed to the FSRTs by virtue of a queue assignment that corresponds to the inquiry s topic. Environmental Monitoring Angela Shaw James Dickson Linda Harris Marcos Sanchez Food Allergens Faith Critzer Michelle Danyluk Marcos Sanchez FSRTs by Queue Assignments Intentional Adulteration Dawn Johnson David Griesemer Michelle Haynes Lead Instructor Application Michelle Haynes David Griesemer Dawn Johnson Recall Plan Michelle Danyluk Linda Harris Marcos Sanchez Regulatory/Rules Interpretation David Griesemer Responds to Question With Link to FDA TAN Foreign Supplier Verification Programs Marcos Sanchez Good Manufacturing Practices Ravi Jadeja Leslie Bourquin Hazard Analysis Linda Harris James Dickson Marcos Sanchez Preventive Controls Michelle Danyluk Faith Critzer Marcos Sanchez Processing Leslie Bourquin James Dickson Process Validation James Dickson Faith Critzer Linda Harris Sanitation Ravi Jadeja Faith Critzer Michelle Danyluk Angela Shaw Linda Harris Leslie Bourquin Supply Chain Programs Marcos Sanchez James Dickson Training/FSPCA Courses Dawn Johnson David Griesemer Michelle Haynes 141

Total Inquiries Submitted to the FSPCA TAN (May 7, 2016 to June 15, 2018) The FSPCA TAN received a total of 1779 inquiries from May 7, 2016 through June 15, 2018. Of the total inquiries received, 71% have been responded to and closed, and 29% remain open. Of the inquiries received during the last 12 months, 98% have been responded to and closed, and 2% remain open. The average response time for a case to close during the last 12 months was 5.3 days. 142

Inquiries Submitted to FSPCA TAN by Case Reason (May 7, 2016 to June 15, 2018) The majority of inquiries submitted to the FSPCA TAN pertained to Lead Instructor and Training issues, as well as questions related to Preventive Controls, and the Foreign Supplier Verification Program. Regulatory inquiries are directed to the FDA TAN. All Inquiries Submitted by Case Reason Training / FSPCA Courses 809 (45.47%) Lead Instructor Application 316 (17.76%) Preventive Controls 214 (12.03%) Foreign Supplier Verification Program 86 (4.83%) Regulatory / Rules Interpretation 67 (3.77%) Other 61 (3.43%) Hazard Analysis 59 (3.32%) Good Manufacturing Practices 38 (2.14%) Supply Chain Programs 28 (1.57%) Food Allergens 20 (1.12%) Other 20 (1.12%) Process Validation 19 (1.07%) Environmental Monitoring 12 (0.67%) Processing 12 (0.67%) Intentional Adulteration 9 (0.51%) Audit 3 (0.17%) Recall Plan 3 (0.17%) Sanitation 3 (0.17%) Total 1779 (100%) 143

International vs. Domestic Inquiries (May 7, 2016 to June 15, 2018) International vs. Domestic Inquiry Count Domestic Cases 1486 (84%) International Cases 293 (16%) Total 1779 (100%) Top International Case Count by Country Mexico 40 (13.65%) Canada 19 (6.48%) Spain 19 (6.48%) Japan 17 (5.80%) International 16% United Kingdom 17 (5.80%) Italy 16 (5.46%) India 12 (4.10%) Domestic 84% In relation to the international inquiries, 38% came from Spanish speaking countries. Chile 11 (3.75%) Colombia 9 (3.07%) Germany 9 (3.07%) Greece 9 (3.07%) France 8 (2.73%) Guatemala 8 (2.73%) Peru 8 (2.73%) Total International Cases 293 144

FSPCA TAN Website Acquisition Data (June 15, 2017 to June 15, 2018) Over 97% of users who visited the TAN Website were directly referred to the TAN by the FSPCA Website, or alternatively bookmarked the TAN Website. Less than 3% of users located the TAN through a Google search, or through social media. Acquisition Channels Referral (from another website) 62.8% Direct (by typing in URL or through bookmark) 34.4% Organic Search (from a search engine like Google) 2.5% Social (from social media like Facebook).2% Email.1% Other 0% 145

FSPCA TAN Summary 1. During the last 12 months great progress has been made in streamlining the inquiry submission process resulting in closing nearly all submitted cases in a timely manner. 2. The majority of cases submitted to the FSPCA TAN relate to Lead Instructor and Training issues. The Scientific cases submitted to the TAN typically pertain to Preventive Controls, the Foreign Supplier Verification Program, Hazard Analysis, and GMPs. 3. Domestic users submit the vast majority of cases to the FSPCA TAN. A significant number of international cases came from Spanish speaking countries. 4. The FSPCA TAN improvement recommendations include optimization for search engines and social media leading to improved resource discovery, and increased user engagement. 146

FDA s FSMA Technical Assistance Network How it Works! FSPCA 2018 Annual Conference July 19, 2018 Deborah S. Price, MS FDA - Center for Food Safety and Applied Nutrition

FDA FSMA Technical Assistance Network Launched FDA s FSMA Technical Assistance Network on September 9, 2015 Provide technical assistance to industry, regulators, academia, and consumers regarding FSMA Address questions related to FSMA rules, programs, and implementation Collaborate with external technical resources, e.g. Alliances, Extension Specialists, Universities, International Partners 148

How to Contact Us? www.fda.gov/fsma FSMA TAN Popular Topics/FAQs Inquiries may be submitted by mail, if internet is not available. Web Form Submission 149

Inquiry Web Form 150

Web Form Auto Response 151

Inquiry Web Form Survey 152

Inquiry Web Form Survey Survey Responses as of June 15, 2018 Were Webform Survey Instructions Clear? Survey Rating Survey Count % of Total 1 14 3% 2 18 4% 3 79 17% 4 120 26% 5 228 50% Total 459 100% How Public Learned of Web Form Rank Term 1 FDA website 2 Search google website 3 Drug info line 4 Customs and Border Protection 5 Premarket box at FDA Areas To Improve Rank 1 2 3 4 5 Term Make FSMA more simple More product types Add attachments Increase text box size Add more FAQ s 153

Inquiry Response Satisfaction Survey 154

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How the FSMA TAN works with FSPCA FDA notes on its FSMA page, for Food Safety Preventive Controls Alliance (FSPCA) training and technical questions, please contact the FSPCA Technical Assistance Network using their web form at: https://fspca.force.com/fspca/s/. FDA periodically checks in with and shares FSMA TAN statistics and exchanges other information with FSPCA and the Produce Safety Alliance. 157

FDA FSMA Technical Assistance Network The FSMA TAN received a total of 9,065 inquiries from September 9, 2015 through June 15, 2018. Of the FSMA inquiries received, 443 still remain open while 8,622 have been responded to and closed. Median response time is 14 days. 158

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 159

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Case Count by Origin AIMS 7 Mail 7 160

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Case Count by FSMA Topic 2 6 2 161

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Case Count by FSMA Topic Percentage of Total FSMA Cases by FSMA Topic 162

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Case Count by Inquirer Category 163

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Case Count by Inquirer Category Percentage of Total FSMA Cases by Inquirer Category 164

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 International vs. Domestic Inquiry Count Top International Case Count by Country 165

FDA FSMA Technical Assistance Network Sept 9, 2015 - June 15, 2018 166

Top 10 PCHF Related Inquiries Sept 9, 2015 June 15, 2018 1. When is a small food manufacturing company exempt from having to develop a Food Safety Plan as required under FSMA? 2. Do all the sub-parts of the PC for Human Food apply when developing the Food Safety Plan? 3. How will the FDA handle farm-related activities on a mixed-type facility that also conducts regular food processing? 4. Does the FDA offer grants to organizations that offer training and operational consulting to smaller companies needing knowledge, training and operational assistance so as to comply with the requirements of FSMA? 167

Top 10 PCHF Related Inquiries Sept 9, 2015 June 15, 2018 5. The Produce Safety Rule requires farms seeking a processing exemption to receive documentation from the processor confirming produce will undergo a kill-step. Does the Preventive Controls rule require firms to provide this documentation to suppliers which provide raw produce? 6. The fundamental aspect to understand is how must we behave with our suppliers since we re based in Italy and consequently how can we ask suppliers to be compliant with HARPC or the Produce Safety Rule, which are US laws and the suppliers operate in Italy? 7. How would the preventive controls for human food rule view food manufacturing facilities using ingredients from common retailers (WalMart, Costco, Restaurant Depot, SAMS Club, etc.) in terms of a supply chain preventive control? 168

Top 10 PCHF Related Inquiries Sept 9, 2015 June 15, 2018 8. Is it a requirement of FSMA that if I purchase something from a distributor that there letter of guarantee covers my hazard analysis, or do I have to go to each distributor that I buy from and go back to the processor to see what they do to control pathogens, etc.? 9. Regarding Seafood HACCP and FSMA Guidance for industry, we have the question: According to the guidance, canned tuna and canned sardine are exempted from 21 CFR 117 subpart C and G. Therefore, if we already have a seafood HACCP program in place then it is my understanding that we do not need to write the hazard analysis and risk based preventive control? 10. When are small businesses (i.e. <500 FT employees) and large businesses (>500 FT employees) that are producers of fluid milk that are not operating under NCIMS Dairy HACCP required to comply with the Preventive Controls for Human Food rule? 169

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Process Improvements (internal): Meet regularly with FSMA Administrators and Specialists Access database with cleared TAN responses on intranet Monthly expanded report showing outstanding inquiries (30/60/60+ days) Implementation of a new Agency-wide phone system as well as Single Sign On (SSO) functionality. Established internal target days for responses Integrated with a new CTI phone system. 170

FDA FSMA Technical Assistance Network Sept 9, 2015 June 15, 2018 Process Improvements (external): Auto-responses after 30/60 days Summary TAN reports posted on web Survey to track effectiveness of web form Survey to track effectiveness of FSMA responses Popular topics posted on the web 135 FAQs 171

Benefits of the FSMA TAN Inquiries inform guidance and other implementation document development Inquirers receive personalized responses about their specific situations Identify gaps and needs that can be addressed by web posting, trainings and other communication Strengthen relationship with external Alliances through information sharing 172

Planned Future Improvements External: Continue to reduce response time for inquiries More information sharing with Alliances and other partners Continue to update FSMA TAN Popular Topics Internal: Implement Salesforce Lightning user functionalities Implement internal cleared response knowledge base 173

Regulator TAN Provides technical assistance regarding FSMA regulations for FDA Investigators before or during the course of an inspection Uses an appointment and phone-based system designed to connect investigators with FSMA Subject Matter Experts Initially supported the Preventive Controls rule and now supports sprout and FSVP inspections but will ultimately support all FSMA regulations 174

Questions? 175

FSMA Mitigation Strategies to Protect Food Against Intentional Adulteration July 2018 176

Background Last of 7 foundational FSMA rules Final rule: May 27, 2016 Establishes requirements to prevent or significantly minimize acts intended to cause wide-scale public health harm Uses a HACCP-type approach, with important differences from the Preventive Controls for Human Food rule Is risk-based and flexible 177

Coverage and Exemptions Facilities that manufacture, process, pack or hold human food Facilities required to register with FDA under sec. 415 of FD&C Act Applies to domestic and imported food Exemptions Very small businesses (<$10 million in sales of human food) Activities under FSMA Produce Rule Animal food Others www.fda.gov 178

What Is Required? Food defense plan Vulnerability assessment Mitigation strategies Procedures for food defense monitoring Food defense corrective action procedures Food defense verification procedures Reanalysis Records Training 179

Qualified Individuals Food defense awareness Vulnerability Assessment Proper implementation of mitigation strategies at actionable process steps Certain components of the food defense plan *Individuals may also be qualified by education or experience 180

Compliance Dates Very small businesses (modified requirements): July 26, 2021 Small businesses (a business with fewer than 500 full-time equivalent employees): July 27, 2020 All other businesses: July 26, 2019 181

Implementation Update 182

Commissioner Blog https://blogs.fda.gov/fdavoice/index.php/2018/03/ 183

Commissioner Blog Commissioner Gottlieb blog March 28, 2018 Emphasizing our commitment to guarding against intentional adulteration AND implementing the rule efficiently Main themes Addressing misconceptions Protecting against an inside attack Upcoming guidance 184

Upcoming guidance Commissioner Blog Actively being worked on Three part draft guidance process 1 st part simple, cost-effective way to identify the most vulnerable parts of the production process, outlines numerous ways to guard against deliberate contamination, as well as ways to monitor the operation (issued June 19, 2018) 2 nd part additional, detailed, and flexible method to identify a facility s most vulnerable points 3 rd part corrective actions, verification, reanalysis, and recordkeeping All guidance will be available for public comment 185

Guidance 186

Guidance Chapters Published in 3 Rounds Introduction 1 Ch 1 Food Defense Plan 1 Ch 2 Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps 1 Section 2C Key Activity Types as a Method for Conducting a Vulnerability Assessment to Identify Significant Vulnerabilities and Actionable Process Steps 1 Section 2F Evaluating the Three Fundamental Elements to Identify Significant Vulnerabilities and Actionable Process Steps 2 Ch 3 Mitigation Strategies for Actionable Process Steps 1 Ch 4 Mitigation Strategies Management Components: Food Defense Monitoring 1 Ch 5 Mitigation Strategies Management Components: Food Defense Corrective Actions 3 Ch 6 Mitigation Strategies Management Components: Food Defense Verification 3 Ch 7 Reanalysis 3 Ch 8 Education, Training, or Experience 2 Ch 9 Records 3 Appendix 1. Food Defense Plan Worksheets 1 Appendix 2. Mitigation Strategies in the Food Defense Mitigation Strategies Database 3 Appendix 3. Calculating Small Business and Very Small Businesses Sizes 3 1 = Round 1, 2 = Round 2, 3 = Round 3 www.fda.gov 187

Round 1 Major Components & Themes Background and definitions Relatively simple and cost-effective method to identify vulnerable points Numerous ways to reduce vulnerabilities Numerous ways to check that strategies are functioning as intended Worksheets to assist industry in thinking through, and documenting, requirements Inter-chapter themes: risk-based, flexible, and practical www.fda.gov 188

Introduction & Food Defense Plan Chapters Glossary Exemptions Description of food defense plan Individual(s) developing the plan Formatting, changing, and maintaining the plan www.fda.gov 189

Chapter 2 Vulnerability Assessment (VA) Overview of requirement Scope of things to consider in VA, grouping of products Preliminary steps before conducting the VA Key Activity Types (KATs) Using KATs to identify vulnerable points www.fda.gov 190

Chapter 3 Mitigation Strategies Overview of requirement Description of what mitigation strategies do and categories of strategies Facility-wide security measures Existing measures Explanations Scenarios www.fda.gov 191

Chapter 4 Monitoring Overview of requirement Difference between food safety and food defense What and how to monitor Monitoring records Continuation of Chapter 3 scenarios www.fda.gov 192

Appendix 1 - Worksheets Food Defense Plan Cover Sheet Food Defense Plan Product Description Food Defense Plan VA Food Defense Plan Mitigation Strategies Food Defense Plan Management Components www.fda.gov 193

Inspection Strategies 194

Inspection Framework Two-level inspectional approach Level 1: Food defense plan Quick-Check inspection Conducted on covered facilities during food safety inspections High level review of Food Defense Plan (FDP) Checks for required sections, plan is current and signed Does not look at details of plan components Conducted by federal and state investigators Anticipated to be conducted for numerous years prior to Level 2 inspections 195

Inspection Framework Two-level inspectional approach Level 2: Comprehensive food defense inspections Conducted only at a limited number of prioritized facilities Conducted by specially trained investigators Critical evaluation of FDP, vulnerability assessment, mitigation strategies, management components, etc. Generates significantly more detailed compliance information Pilot with federal investigators then reassess program for federal and state investigators 196

Training 197

Training Established the Intentional Adulteration Subcommittee within the Food Safety Preventive Controls Alliance to create training and technical assistance programs Courses for industry are well into development and implementation Specific Regulator Courses for the IA Quick-Check and the Comprehensive Inspections are in planning stages 198

Role of Individual Method of Training Current thinking and subject to change Individuals assigned to an actionable process step (including temporary and seasonal personnel) Online course Food Defense Awareness Supervisors of those individuals assigned to an actionable process step (including temporary and seasonal personnel) Online course Food Defense Awareness Individual(s) conducting or overseeing: the preparation of the food defense plan or reanalysis Online course Food Defense Plan Preparation and Reanalysis Individual(s) conducting or overseeing: the vulnerability assessment In-person one day training Conducting Vulnerability Assessments Individual(s) conducting or overseeing: the vulnerability assessment using only Key Activity Types Online course Key Activity Types Individual(s) conducting or overseeing: the identification and explanation of mitigation strategies Online course Mitigation Strategies 199

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www.fda.gov/fooddefense Jon Woody, Director, Food Defense, FDA jon.woody@fda.hhs.gov 240-402-2171

MARKETING TIPS AND TACTICS FOR PROMOTING COURSES Matthew Botos CEO/President, ConnectFood Jerry Wojtala Executive Director, International Food Protection Training Institute (IFPTI)

Marketing Tips Find Your Audience You already have an idea of who the course is for. The question is, have you gone deep enough? 203

Marketing Tips Enlist the help of your peers and colleagues Ask those in your inner circle to help you spread the word. Marketing something you care about is always more effective when you have assistance in doing so. If you don t have an inner circle yet, start now to cultivate one! That means joining us for the reception later or creating a mastermind, a blogging group or other small team of peers. 204

Marketing Tips Use the reputation of the Alliance Add that you are an FSPCA Lead Instructor in your advertising Use the FSPCA logo Download a high quality file from the Lead Instructor Resource Portal. 205

Marketing Tips Utilize technology Eventbrite Facebook LinkedIn SEO Google Ad words Create a Website! 206

What is Your Unique Proposition How do you differentiate yourself from competitors? Language Specific audience Expertise Reputation ROI Add Value Offer other services did you share the link to the intentional adulteration course? Consultation Tools 207

Internet Tools Blog Post YouTube Channel YouTube Promotional Video Course link in your email signature Dedicated Webpage Link enewsletter Podcast Live Webinar Offer Free Modules, Mini-Courses Constant Contact, email lists 208

Course Promotion Relevance be a solution to a problem Cross-promote between your courses Create programs, bundles Create a Sales Page (not a course description) Partner with other instructors, companies Create affiliates Post participant ratings, testimonials Trade Show Booth 209

Course Pricing Perceived Value Don t underprice your course! Satisfaction Guarantee Payment Plan Volume- or Early-Bird Discounts Loss-Leaders Check the going-rate on FSPCA website 210

Sell Yourself Include your best sample clips Be an Expert Thought Leadership Sign up for HARO (Help a Reporter Out) Present at conferences Be interviewed podcasts, trade journals Publish Amazon digital book, trade journals Answer questions on Quora Comment on Facebook, LinkedIn groups, forums Edit your profile on FSPCA Website 211

Adding Yourself to the List of Lead Instructors Creating a Public Listing: 1. Log into the Community: https://fspca.force.com/fspca/s/ 2. Click on your Name, on the top right of the page 3. Click on My Profile 4. Click Edit 5. Check the Make Profile Public box 6. FSPCA Courses Taught: this identifies which courses you will teach* 7. North American Travel Range: where in the US and Canada are you prepared to travel to?* 8. International Travel Regions: which global regions are you prepared to travel to?* 9. International Travel Region: Provide more details if necessary 10. Languages Spoken: which languages are you comfortable training in? 11. Save: when complete, scroll to the bottom of the page and Save *Use Ctrl-click/Cmd-click to select multiple values 212

Instructor Metrics Couse Type # of LIs Active Instructors Courses per Active instructor Human Food 1569 553 (35%) 8.4 Animal 230 126 (55%) 2.9 FSVP 248 63 (25%) 5.3 Completed Courses FSPCA Courses United States International Total Human Food 2570 2091 4661 Animal Food 331 42 373 FSVP 269 70 339 213

Human Food courses 52 214

Animal Food courses 215

FSVP courses 216

Certificates 217

INTRODUCTION OF THE NEW FSVP MODULE David Gombas Senior Vice President Food Safety and Technology, United Fresh Produce Association (retired)

Foreign Supplier Verification Programs (FSVP) Requirements ENSURING THE SAFETY OF FOODS IMPORTED INTO THE UNITED STATES FOR HUMAN AND ANIMAL CONSUMPTION

FSVP Module Description and Target Audience Module Description: This module will provide participants with an understanding of the requirements of the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals regulation. Target Audience: This module is designed specifically for the foreign suppliers that manufacture, process, pack, or hold food intended for human or animal consumption in the U.S. The FSVP rule requirements are directed at importers, not foreign suppliers.

FSVP Module: Goal and Learning Objectives Goal: Upon completing this module, participants will be able to: Recognize how to support U.S. importers in meeting their FSVP responsibilities. Learning Objectives: Upon completing this module, participants will be able to: 1. Explain the purpose of FSVP requirements. 2. Define an FSVP importer. 3. Define a foreign supplier. 4. Describe the foods subject to and exempt from FSVP requirements. 5. Describe the FSVP requirements (standard and modified) and to whom they apply. 6. Discuss the importance of early communication between importers, foreign suppliers, and others in the supply chain in meeting FSVP requirements.

Purpose of the FSVP Rule The purpose of the FSVP rule is to ensure that foreign suppliers of human and animal food that will be consumed in the U.S. are: Producing food using processes and procedures that provide at least the same level of public health protection as required under the FDA rules for risk-based preventive controls or produce safety, unless specifically exempted, and Producing the food in compliance with sections 402 (regarding adulteration) and 403(w) (regarding labeling of human food for the presence of major food allergens) of the FD&C Act.

FDA Definitions Food: (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (Section 201(f), FD&C Act) Adulterated: Adulterated food is food that violates Section 402 of the Food Drug and Cosmetic Act (FD&C Act) and is, therefore, subject to being refused entry into the U.S. Allergen Labeling: Allergen labeling refers to the labeling of human food for the presence of major food allergens that must be in compliance with Section 403(w) of the FD&C Act.

FDA Definitions (continued) Foreign Supplier: for an article of food, the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature. (21 CFR 1.500)

FDA Definitions (continued) Importer (for FSVP purposes): the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart. (21 CFR 1.500)

FDA Definitions (continued) Qualified Individual (for FSVP purposes): a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required by the FSVP rule, and can read and understand the language of any records that the person must review in performing this activity (21 CFR 1.500)

What Foods Are Covered By FSVP? FSVP applies to all human and animal food offered for import into the U.S. and intended for consumption in the U.S., unless exempted. Exemptions that apply to foods imported into the U.S. include foods that are: Imported for research or evaluation, Imported for personal consumption, Transshipped through the U.S. or imported for further processing and export (no distribution in the U.S.), and or Produced in the U.S., then exported and returned. Certain meat, poultry, and egg products are also exempt because they are regulated by the U.S. Department of Agriculture (USDA).

What About Low-Acid Canned Foods? An importer of low-acid canned foods (LACFs) must: Verify and document that the food was produced in accord with LACF regulations (21 CFR Part 113) which focus on microbiological hazards. For all matters not controlled by the LACF requirements, i.e., non-microbiological hazards, the importer is required to have an FSVP. An importer of raw materials or other ingredients to be used in manufacturing /processing an LACF in the U.S.: Is not required to comply with FSVP requirements for microbiological hazards, if the importer is in compliance with Part 113, but Must have an FSVP for all other known or reasonably foreseeable hazards.

What About Foods Under FDA HACCP Rules? Foods complying with FDA HACCP rules for juice (21 CFR Part 120) and seafood (21 CFR Part 123) are exempt from FSVP because the HACCP rules contain their own supplychain requirements for importers of those foods. Importers of raw materials and ingredients for the manufacture of juice or seafood need not comply with FSVP so long as the U.S. facility is in compliance with FDA HACCP requirements under parts 120 and 123, respectively, as these importers will be addressing all the hazards associated with those ingredients under FDA HACCP.

Exemption for Alcoholic Beverages FSMA and FDA exempted alcoholic beverages that meet certain conditions: The foreign facility is same type of facility as those regulated by the U.S. Department of Treasury. The foreign facility is required to register under Sec. 415. This provision is basically the same exemption as for domestically produced alcoholic beverages under the Preventive Controls for Human Food rule.

What if the U.S. Importer is a Processor Who Imports Ingredients? The Preventive Controls rules contain supply-chain provisions similar to those in the FSVP rule. If a U.S. importer is subject to and in compliance with the supply-chain provisions of the Preventive Controls rules, the importer is deemed to be in compliance with most of the FSVP requirements for the food being imported. However, a facility must still identify itself as the FSVP importer, in the Customs and Border Protection (CBP) entry filing in accordance with the FSVP rule.

Standard FSVP Requirements In addition to verifying that their foreign supplier is following the Preventive Controls rules, U.S. importers of food are required to develop, maintain, and follow an FSVP for each type of food they import including: Conducting a hazard analysis to identify known or reasonably foreseeable biological, chemical, and physical hazards, Evaluating and approving each foreign supplier, Determining what foreign supplier verification activities are necessary and appropriate as well as their frequency, Taking corrective actions based on verification activities, and Reevaluating their FSVP whenever they become aware of a food safety problem and at least every three years. Identifying the FSVP importer at entry. Documenting all of the above, keeping adequate records, and making those records available to FDA upon request.

Hazard Analysis FSVP importers must identify and evaluate known or reasonably foreseeable hazards to determine if they require a control, including: Biological, chemical (including radiological), and physical hazards, and Hazards that are naturally occurring, unintentionally introduced, or intentionally introduced for economic gain. This hazard analysis must be documented by the FSVP importer.

Evaluation and Approval of the Foreign Supplier FSVP importers must evaluate each foreign supplier s performance, including: Processes and procedures for ensuring food safety, and Its history of compliance with food safety requirements. FSVP importers must approve each foreign supplier and have written procedures to ensure use of approved foreign suppliers only. May use an unapproved supplier on a temporary basis if necessary.

Verification Activities Before importing, FSVP importers must: Select and conduct one or more appropriate verification activities to verify that the hazards required to be controlled by their suppliers have been significantly minimized or prevented. Verification activities are required for all hazards requiring a control. FSVP Importers must determine, not only appropriate verification activities, but also the frequency of those activities based on food risk and supplier evaluations.

Audits, Appropriate Verification Activities FDA has stated that appropriate verification activities include: Audits are the default verification activity for a Serious Adverse Health Consequences or Death to Humans or Animals (SAHCODHA) hazard, but another verification activity may be chosen, if adequate, Sampling and testing, Review of foreign supplier records that demonstrate production of safe food, and Other appropriate verification activities for known or reasonably foreseeable hazards requiring a control.

Verification of Findings and Corrective Actions The FSVP importer must: Ensure that verification activities are performed properly. If an importer determines that its foreign supplier is not producing food in a manner that provides at least the same level of public health protection as U.S. safety standards, such as the Preventive Controls rules, the importer must document and correct any deficiencies. Corrective actions may include using a different foreign supplier.

Regular and For Cause Reevaluation of FSVPs FSVP importers must regularly reevaluate their hazard analysis (food risk) and foreign supplier performance every three years to see if their FSVP is still valid. Importers must also promptly reevaluate their FSVP if they become aware of a food safety problem with the food they import, including a food safety problem they discover as the result of a verification activity.

Creating and Maintaining Records All documentation that is required by the FSVP rule must be complete, must be kept for at least two years, and must be made available to FDA upon request.

FSVP Importer is Accountable Reliance on Others FDA will hold the FSVP importer accountable for meeting all of the requirements of the FSVP rule. The FSVP rule permits, however, the FSVP importer to rely on others, including its foreign suppliers, to perform many FSVP functions so long as each of those functions are performed by a qualified individual and each is reviewed by the FSVP importer s qualified individual. EXCEPT: The importer cannot rely on an audit conducted by the foreign supplier.

Modified Requirements Some importers and/or their foreign suppliers may meet criteria that allow for modified FSVP requirements. The importers and/or the foreign supplier must demonstrate/document that they meet the eligibility criteria. Modified FSVP requirements apply: If the importer is a very small importer, If the imported food is from certain small foreign suppliers, If the imported food is from foreign supplier(s) in countries with food safety systems recognized by FDA as comparable or equivalent, or If the importer imports dietary supplements or dietary supplement components.

Certain Small Foreign Suppliers A foreign supplier meets the criteria for Certain Small Foreign Suppliers if the foreign supplier is: A qualified facility as defined by the Preventive Controls rules, A farm that grows produce and is not a covered farm under the Produce Safety rule (i.e., < U.S. $25,000 average produce sales) or satisfies Produce Safety rule requirements for a qualified exemption, or A foreign supplier of shell eggs that is not subject to the FDA regulation for Shell Eggs in 21 CFR Part 118 because it has fewer than 3,000 laying hens.

Modified Requirements When Importing from Certain Small Foreign Suppliers If an FSVP importer is importing food from one of these three categories of certain small foreign suppliers and wants to be subject to the modified FSVP requirements: The importer must obtain written assurance from the foreign supplier that it meets the specified criteria for one of the three categories before approving the supplier for each applicable calendar year.

Modified Requirements When Importing from Qualified Facilities If a foreign supplier is a qualified facility, the FSVP importer needs to: Obtain written assurance before importing the food and at least every 2 years thereafter that the foreign supplier is producing the food in compliance with applicable FDA food safety regulations, or laws and regulations of a country whose food safety system has been recognized by FDA to be comparable or equivalent, and That assurance must include a brief description of the supplier s preventive controls, or a statement of compliance with relevant State or other non-federal, including foreign, food safety laws and regulations.

Very Small Importers A very small importer is an importer that during the previous 3-year period averages less than U.S. $1 million (human food importers), or less than U.S. $2.5 million (animal food importers) per year in sales of food; plus market value of food imported, processed, or held without sale. These calculations are adjusted for inflation with 2011 as the base year. These figures include sales of any subsidiaries and affiliates.

Modified Requirements for Very Small Importers Very small importers must obtain from their foreign supplier: Written assurance that the food is being produced in compliance with processes and procedures that provide at least the U.S. level of public health protection, and Written assurance that food is in compliance with U.S. adulteration and allergen labeling provisions (for human food). This must be done for every imported food, and needs to be done before first importing the food and every 2 years thereafter.

What If the FSVP Importer Is Not a Very Small Importer, but Imports from Certain Small Foreign Suppliers? If the FSVP importer does NOT qualify as a very small importer, but does import from certain small foreign suppliers, the importer must: Evaluate the foreign supplier s compliance history, Approve the foreign supplier, and Use only approved foreign suppliers. Importers must obtain written assurance from the foreign supplier that acknowledges that its food is produced in compliance with applicable FDA food safety regulations, or When applicable, the relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the U.S.

What If Assurances Are Invalid? If a very small importer or an importer importing from a certain small foreign supplier determines that a foreign supplier of food does not produce the food consistent with the written assurances the foreign supplier provided, the importer must promptly take appropriate corrective actions.

What Are Appropriate Corrective Actions? The appropriate corrective actions will depend on the circumstances, but could include discontinuing use of the foreign supplier or another suitable alternative. FSVP importers must document any corrective actions they take.

If Food Is from A Recognized System If a foreign supplier is under the regulatory oversight of a governmental authority whose food safety system FDA has officially recognized as comparable or equivalent to that of the U.S., the FSVP importer is not required to: Perform a hazard analysis, Conduct a foreign supplier evaluation for supplier approval, nor Conduct the supplier verifications as described earlier.

If Food Is from A Recognized System (continued) However, before importing a food from the foreign supplier, the FSVP importer must determine and document that the foreign supplier is: Under the oversight of the regulatory authority with whom FDA has the systems recognition agreement, Within the scope of the of the systems recognition agreement, and In good compliance standing with the recognized food safety authority. If any information indicates food safety hazards associated with the food are not being significantly minimized or prevented, the FSVP importer must take prompt corrective action.

The Importance of Communications Within Your Supplier/Importer Chain The new FDA regulations for Preventive Controls, Produce Safety and FSVP anticipate that those involved in the food supplier/importer chain will communicate with each other before the compliance dates for these rules. Foreign suppliers may be asked to provide additional documentation to the FSVP importer. Everyone in the foreign supplier/importer chain could benefit by initiating discussions as soon as possible about their individual roles in complying with the new U.S. food safety requirements.

FSVP Module for Preventive Controls: Summary FSVP importers are responsible for verifying that their foreign suppliers are supplying food that meets the U.S. level of public health protection and is not adulterated under Section 402 of the FD&C Act or in violation of the allergen labeling provisions of Section 403(w) (for human foods) of the FD&C Act. FDA will hold FSVP importers accountable for: Conducting a hazard analysis to identify known or reasonably foreseeable hazards, Evaluating and approving their foreign suppliers, Determining what foreign supplier verification activities are necessary and appropriate as well as their frequency, Taking corrective actions when necessary, Reevaluating their FSVP for cause and at least every three years, Assuring that they are properly identified as the FSVP importer on entry filing, and Documenting all of the above, keeping adequate records, and making those records available to FDA upon request. FSVP importers may use modified requirements in some situations.

FSVP Module for Preventive Controls: Questions Thank you for your attention! Questions?

ASK AN EXPERT SESSION Claudia Coles Policy & External Affairs Advisor, Washington State Department of Agriculture (WSDA)

Ask an Expert Session Details There are 5 topics and breakout rooms The topics are Foreign Supplier Verification Programs (FSVP), Preventive Controls for Animal Food (PCAF), Intentional Adulteration (IA), PC Human Food Inspection Implementation and PC Guidance Each session will be in an open Question & Answer format Refer to your Conference map for topic room locations Please take the first 30 minutes of the lunch break to attend to personal business and get some lunch There are tables in each breakout room for you to sit and have your lunch. There is also a Lunch-only room for those who do not wish to attend a breakout session. Ask an Expert Q&A sessions begin at 12:30 pm and end at 1:15 pm You are free to attend any of the five breakout rooms, however, we recommend you choose the topic that is of the most interest to you and attend the full 45 minutes in order to get the most benefit from the session Lunch buffet is located in the hallway. Enjoy! 256

FSPCA Conference: FDA FSMA Guidance Overview July 18-19, 2018 Jenny Scott Senior Advisor Office of Food Safety Center for Food Safety and Applied Nutrition Dianne Milazzo Consumer Safety Officer Office of Surveillance and Compliance Center for Veterinary Medicine Sharon Lindan Mayl Senior Advisor for Policy Office of Foods and Veterinary Medicine

CGMP & Preventive Controls for Human Food 258

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PCHF Guidance FDA has issued a variety of guidance documents that can be linked to from the page for the PCHF rule. 262

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Downloading the Guidance Full Guidance Download the full Hazard Analysis and Risk-Based Preventive Controls for Human Food - Draft Guidance (PDF: 4MB) Note: The tables in Appendix 1 encompass more than 200 pages. To reduce the printed size of this document (which includes all of the available chapters in this guidance), we have not included those tables. To access the tables in Appendix 1, see the separate Appendix 1 (complete with tables) 264

Forthcoming PCHF-Related Guidance Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 11: Food Allergen Controls Classification of Food as RTE or NRTE www.fda.gov 265

Animal Food and Joint Guidance Documents Dianne Milazzo, Consumer Safety Officer Ofc of Surveillance and Compliance/ CVM Email: dianne.milazzo@fda.hhs.gov Ofc: 240-402-6670 Cell: 804-334-4350 FSPCA CONFERENCE JULY 18-19, 2018

Joint PCAF and other FSMA Regulation Guidance Documents 11 Qualified Facility Attestation Guidance Disclosure Statement for Customer Provisions Activities Classification Solely Engaged Exemption Clarification Determining Number of Employees for Purpose of Small Business Status Draft Draft Draft Draft Draft

Solely Engaged Draft Guidance 12 Developed because FDA has received numerous questions on what it means to be solely engaged Intended audience is those questioning whether they are solely engaged Provides policy direction when a facility is doing two activities at the same place that are both exempt under the solely engaged exemptions May not answer every solely engaged question

PCAF only Guidance Documents 13 Available Guidance Small Entity Compliance Guidance (#241) Current Good Manufacturing Practice (#235) Human Food By-Products for Use as Animal Food (#239) Hazard Analysis and Preventive Controls (#245) Supply-Chain Program (#246) Status Final Final Draft Draft Draft

CGMP #235 Final Guidance 14 Updated based on comments to guidance and feedback from industry Updates to be aware of: Changes made to qualified individual training record retention explanation Added more clarity around food grade lubricants Removed discussion on 21 CFR 507.28 (human food byproducts) and referenced that guidance 507.27 discussion updated to reflect Sanitary Transportation regulation Added Self-assessment tool at end of guidance document

HAPC Guidance #245 - Summary Five chapters provide guidance on: components of a food safety plan and the importance of each component how to conduct a hazard analysis and develop a food safety plan for the animal food that you produce biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food identifying preventive controls for biological, chemical, and physical hazards associated with animal food preventive control management components recordkeeping requirements associated with the food safety plan and implementation of the food safety plan 15

HAPC Guidance #245: Things to Keep in Mind There is flexibility in how to apply these requirements Facilities should take a scientificbased, yet practical, approach to implementation Not all hazards will be a hazard for all facilities Focus on the parts that are relevant to you We want your comments and feedback 16

17 Supply-Chain Program Guidance #246 Provides in-depth information on supply-chain program requirements: Explains responsibilities of facilities that receive raw materials and other animal food ingredients Thorough information on verifying control of hazards by suppliers Establishes a frequency of verification activities Provides information on approving suppliers Provides information on exceptions Requirements of recordkeeping

Non-PCAF FSMA Guidance of Interest 18 Available Guidance Status 7 th Edition Food Facility Registration Guidance Draft Third-Party Certification Body: Model Accreditation Standards VQIP Small Entity Compliance Guidance for Sanitary Transportation Sanitary Transportation Waiver Clarification Small Entity Compliance Guidance for Registration of Food Facilities Final Final Final Final Final

FSVP Guidance Documents, Enforcement Discretion, and Supplier Evaluation Resources 275

Key FSVP Guidance Documents Compliance Guide: Draft Published 1/18 Small Entity Compliance Guide: Published 1/18 Recognition of Acceptable UFI: Published 3/17 Compliance with UFI: Published 5/17 Considerations for Determining Whether A Measure Provides the Same Level of Public Health Protection: Draft Published 1/18 (also relevant to PC and Produce rules) 276

FSVP Compliance Guide To What Foods Does the FSVP Regulation Apply? (21 CFR 1.501) What FSVP Must I Have? (21 CFR 1.502) Who Must Develop My FSVP and Perform FSVP Activities? (21 CFR 1.503) What Hazard Analysis Must I Conduct? (21 CFR 1.504) What Evaluation for Foreign Supplier Approval and Verification Must I Conduct? (21 CFR 1.505) What Foreign Supplier Verification and Related Activities Must I Conduct? (21 CFR 1.506) What Requirements Apply When I Import a Food That Cannot Be Consumed Without the Hazards Being Controlled or for Which the Hazards Are Controlled After Importation? (21 CFR 1.507) 277

FSVP Compliance Guide (cont d) What Corrective Actions Must I Take Under My FSVP? (21 CFR 1.508) How Must the FSVP Importer Be Identified at Entry? (21 CFR 1.509) How Must I Maintain Records of My FSVP? (21 CFR 1.510) What FSVP Must I Have if I Am Importing a Food Subject to Certain Requirements in the Dietary Supplement Current Good Manufacturing Practice Regulation? (21 CFR 1.511) What FSVP May I Have if I Am a Very Small Importer or I Am Importing Certain Food from Certain Small Foreign Suppliers? (21 CFR 1.512) What FSVP May I Have if I Am Importing Certain Food from a Country with an Officially Recognized or Equivalent Food Safety System? (21 CFR 1.513) What Are Some Consequences of Failing to Comply with the FSVP Requirements? (21 CFR 1.514) 278

Guidances on Identification at Entry For each line entry of food, the importer must provide its legal business name, electronic mail address, and an acceptable Unique Facility Identifier (UFI) FDA formally recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI The Customs and Border Protection (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements. FSV should be used if the entry is subject to the FSVP regulation Will then ask for the importer s name, email address, and UFI (i.e., DUNS number) Note: Temporary use of UNK instead of DUNS number One of Two Affirmation of Compliance Codes: FSX should be used to designate that the food is exempt from FSVP or that compliance with FSVP is not yet required; OR RNE should be used to designate, more specifically, that the food is exempt from FSVP because it will be used for research or evaluation. 279

Enforcement Discretion The agency issued several ED guidances in response to industry feedback Purpose: To state the intent of the FDA not to enforce certain regulatory requirements as they currently apply to certain entities and/or activities. 280

Enforcement Discretion Guidances Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Published 11/17 Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Published 1/18 Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Published 1/18 Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Published 3/18 281

Enforcement Discretion Guidances These guidances cover the following: Facilities that would be farms except for certain factors Written assurance requirements in the FSVP, PC Human, PC Animal, and Produce rules Animal PC requirements for certain human by-products for use as animal food FSVP requirements for importers of food contact substances FSVP requirements for importers of grain Raw Agricultural Commodities Certain supply-chain requirements for co-manufacturers FSVP requirements for importers of live animals that must be slaughtered and processed at establishments regulated by USDA and subject to HACCP requirements 282

Facilities That Would Be Farms : Why Is Enforcement Discretion Needed? FDA intends to initiate a rulemaking that could change the applicability of the preventive controls and CGMP requirements to some entities that conduct farm-related activities. A change to the farm definition could change the status of an entity from a facility required to register to a farm. A farm is not subject to the preventive controls or CGMP requirements but may be subject to the produce safety regulation, depending on the food and activities involved. To provide sufficient time to pursue the future rulemaking related to farm activities and other solutions to the concerns regarding the applicability of parts 117 and 507, we intend to exercise enforcement discretion with regard to the preventive controls requirements (and, in some cases, the CGMP requirements) of parts 117 and 507. 283

Facilities That Would Be Farms : To What Facilities Does Enforcement Discretion Apply? Any operation (not located on a primary production farm) that is dedicated to harvesting, packing, and/or holding RACs, Facilities engaged in farm-related activities on produce RACs (e.g., produce packinghouses and warehouses), Facilities engaged in farm-related activities on nonproduce RACs (e.g., egg packinghouses and grain elevators), Facilities engaged in nut hulling/shelling operations, Facilities engaged in the ginning of cotton, and Facilities engaged in conditioning seed for cultivation that solely pack and hold seed for use in animal food 284

Supplier Evaluation Resources 285

Supplier Evaluation Resources 286

Supplier Evaluation Resources 287

Supplier Evaluation Resources 288

Supplier Evaluation Resources 289

QUESTIONS? 34

ASK AN EXPERT REPORT OUT Claudia Coles Policy & External Affairs Advisor, Washington State Department of Agriculture (WSDA)

Ask an Expert Report Out FSVP If a company has its own subsidiary as an importer, who is responsible for FSVP? What is the definition of FSVP importer and, if there are multiple entities that meet the definition, who has to comply? What do you have/need to do for produce? If a product is exempt for produce safety, is it exempt for FSVP? What is the most important task for a FSVP importer? 292

Ask an Expert Report Out IA There was a broad conversation about implementation and training. Here are a few of the most common questions. It appears we will need to increase vetting of our employees. It appears this may involve conducting credit checks to determine if employees might be economically motivated to do harm for money. Are there legal ramifications with regard to employee privacy? It was mentioned in the presentation that Quick Check inspections will be conducted by State and Federal inspectors. Will that be added into the State contract? If so, which contract year? How and when will state inspectors be trained. 293

Ask an Expert Report Out PC Guidance Materials Many questions about appendix 1 of the draft hazard guidance? When will revisions to appendix 1 and remaining chapters be ready? Discussion about firms having a HACCP plan but not a written food safety plan. Recommend a GAP analysis PCAF It seems the FSPCA Annual Conference is all about Human Food What are the Pros and Cons on assessments? Can others using pre/post assessments share them? 294

Ask an Expert Report Out PCHF Inspection Implementation Environmental sampling Discussion on improving the process. How to expedite the sampling process When to sample Should product be put on hold Performing the inspections What is a full PC inspection vs a limited scope inspection? What training are inspectors required to take before performing PC inspections? How will inspectors handle inspecting firms that have multiple types of foods such as PC, Juice, Seafood? What are high risk products vs low risk products? How are they defined. 295

FSPCA TOWN HALL Kathy Gombas Co-Chair, FSPCA International Subcommittee and ToT Work Group

Moderator and Panelists Moderator Kathy Gombas Panelists FSVP: Sharon Mayl, FDA IA: Jon Woody, FDA PCHF: Jenny Scott, FDA PCAF: Dianne Milazzo, FDA Implementation: Jerry Wojtala, IFPTI FDA Inspections: Glenn Bass, FDA 297

Rules of Engagement Topic-specific notecards were provided in advance of the Town Hall The moderator has sorted through the notecards in order to group similar questions The moderator will kick off the session referring to the questions submitted and directing the appropriate panelist(s) to answer We will end the Town Hall session with an live Q&A portion Two floor microphones will be placed in the aisles and you, the conference participants, are invited to line up to ask your question The moderator will direct questions to the appropriate panelist(s) If there should be a lull during the live Q&A portion, the moderator will refer back to the notes cards for further questions 298

CLOSING REMARKS Robert Brackett Jason Wan Institute for Food Safety and Health (IFSH) Illinois Institute of Technology (IIT)

Day 2 Wrap Up To help us continually improve the FSPCA Annual Conference, please take the 2-minute survey you will receive after the meeting. We d love to hear from you! 300

THANK YOU!