Update on FSMA Implementation. Rebecca Buckner May 24, 2016

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1 Update on FSMA Implementation Rebecca Buckner May 24, 2016

2 Presentation Overview FSMA Implementation Rulemaking and Industry Guidance - Focus on the Preventive Controls Rules FSMA Implementation Guiding Principles - Industry Training /Technical Assistance - Regulator Training /Technical Assistance 2

3 FSMA Implementation A Continuum Phase 1: Set Standards Develop regulations, guidance, policy Phase 2: Design Strategies to Promote and Oversee Industry Compliance Identify performance metrics to measure success 3

4 Phase 1: Standard Setting Regulation Proposal Final Preventive Controls (Human Food)* Jan 16, 2013 Sept 17, 2015 Preventive Controls (Animal Food)* Oct 29, 2013 Sept 17, 2015 Produce Safety* Jan 16, 2013 Nov 27, 2015 Foreign Supplier Verification Program* Jul 29, 2013 Nov 27, 2015 Third Party Accreditation Jul 29, 2013 Nov 27, 2015 Sanitary Transport Feb 5, 2014 April 6, 2016 Intentional Adulteration Dec 24, 2013 May 31, 2016 *Supplemental proposals published September 2014 Final rule publication date 4

5 Human Food Preventive Controls Rule Key Areas Addressed Hazard Analysis and Risk-Based Preventive Controls Each facility is required to implement a written food safety plan that focuses on preventing hazards in foods Update Current Good Manufacturing Practices 5

PC Rule for Human Food Businesses Compliance Dates Small Business business with fewer than 500 full-time equivalent employees Very Small Business average less than $1M per

6 PC Rule for Human Food Businesses Compliance Dates Small Business business with fewer than 500 full-time equivalent employees Very Small Business average less than $1M per year in sales of human food plus the value of such food manufactured, processed, packed or held without sale Separate Compliance Dates Established for Supply-Chain Program 6

7 Phase 2 FSMA Implementation Gaining and Maintaining Industry Compliance with FSMA Final Rules 7

8 Key Implementation Principles Industry Education, Outreach, Technical Assistance Facilitate industry compliance with prevention oriented standards through: guidance, developing tools/resources for education, outreach and technical assistance Guidance Documents Alliances Technical Assistance Networks 8

9 Planned Guidance Documents (Human Food) Hazard analysis and preventive controls Supplier controls Food allergen controls Validation of process controls A Small Entity Compliance Guide that explains the actions a small or very small business must take to comply with the rule 9 9

Alliances Produce Safety Alliance (PSA) Centered at Cornell University Developed a curriculum to train the farming community Sprout Safety Alliance (SSA) Centered at the Illinois Institute of

10 Alliances Produce Safety Alliance (PSA) Centered at Cornell University Developed a curriculum to train the farming community Sprout Safety Alliance (SSA) Centered at the Illinois Institute of Technology Developed a curriculum to train sprout growers Food Safety Preventive Controls Alliance (FSPCA) Centered at the Illinois Institute of Technology Developed curricula to train those that manufacture, process, hold and distribute human and animal food 10

FSPCA Human Food Curriculum Content (Exercises Throughout) Introduction to Course Food Safety Plan Overview GMPs and Prerequisite Programs Biological Food Safety Hazards Chemical, Physical and

11 FSPCA Human Food Curriculum Content (Exercises Throughout) Introduction to Course Food Safety Plan Overview GMPs and Prerequisite Programs Biological Food Safety Hazards Chemical, Physical and Economically Motivated Food Safety Hazards Preliminary Steps Resources for Preparing a Food Safety Plan Hazard Analysis and Preventive Control Determination Process Preventive Controls Food Allergen Preventive Controls Sanitation Preventive Controls Supplier Preventive Controls Verification and Validation Procedures Record-keeping Procedures Recall Plan Regulation Overview 11

outreach and technical assistance for industry & regulators Part 1:

12 Technical Assistance Networks Establish an FDA FSMA Technical Assistance Network to provide central, consistent sources of outreach and technical assistance for industry & regulators Part 1: FSMA Rule Interpretation Questions Part 2: Food Safety Regulatory Community 12

13 Technical Assistance Network Launched FDA s FSMA Technical Assistance Network on September 10, 2015 Provide technical assistance to industry, regulators, academia, and consumers regarding FSMA Address questions related to FSMA rules, programs, and implementation FDA At-a-Glance - How to Submit a Question Submit inquiries via the web form or by mail To submit a question about FSMA, visit and go to Contact Us 13

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15 Technical Assistance for Industry Collaboration with FSPCA Preventive Controls Scientific & Technical Questions from Industry a web form at: FSMA Regulation & Policy Interpretation Questions a web form at: Extension Specialists CVM CFSAN Land Grant Universities International Partners ORA KMS OIP 15

16 FDA Technical Assistance Questions will be tracked and trended using the Knowledge Management System Repeat questions will be addressed in FAQs or guidance documents posted on 16

17 Key Implementation Principles Regulator Education, Outreach and Technical Assistance Invest in regulator training/continuing education, on-going calibration of regulators to promote consistent inspections and decision making Industry Best Practices Webinars Alliance Courses with Industry Regulator Specific Training Mentors and Technical Assistance Network 17

18 FSMA Rule Readiness Training Every other month 2016 Sessions Events for sharing industry best practices & FDA perspectives Recall Readiness February Third Party Audits April Food Safety Culture 301 June Sanitation Essentials August Application of Animal Food cgmps October Intentional Adulteration December 18

19 Alliance Courses with Industry *Food Safety Staff Attend FSPCA Training Food Safety Staff attend with Industry (2.5 day participant course) Prerequisite to PC regulator training Provides basic understanding of PC rules, hazards & PCs, and how to develop a food safety plan *Food Safety Staff: Managers/Supervisors, Subject Matter Experts, Compliance Officers, FDA Investigators, State Regulators 19

20 PCHF Regulator Specific Training Curriculum Development Modernized Human Food CGMP Webinar Regulator Train the Trainer Course Regulator Participants Course Training Delivery phased in FY Train the Trainers & Instructor Cadre 20

21 FDA PC Regulator Training Delivery Model Train-the-Trainers (TTTs) Train Instructor Cadre Instructor Cadre Train Food Safety Staff - Phased in FY16-18 Food Safety Staff Conduct Inspections - Phased in by Business Size FY

22 Regulator Technical Assistance Establish FDA FSMA Technical Assistance Network to provide central, consistent sources of outreach and technical assistance for industry & regulators Part 1: FSMA Rule Interpretation Questions for various stakeholders Part 2: Food Safety Regulatory Community Questions before, during and after inspections 22

23 Other FSMA rulemakings Implementation for the other six FSMA rulemaking will generally follow the same principles. Guidance documents Alliances Technical Assistance Network Regulator Education 23

24 Other Areas of Interest Educate before and while we regulate what does that mean? Non-FDA public and private oversight schemes Systems Recognition Other government partners Private third party audits 24

25 Public Information Web site: Subscription feature available To submit a question about FSMA, visit and go to Contact Us 25

FSMA Implementation FDA s Preventive Controls Rules

FSMA Implementation FDA s Preventive Controls Rules 2016 National Association of Dairy Regulatory Officials Annual Meeting July 11, 2016 CAPT Robert (Bob) Hennes, MST Leader Presentation Overview FSMA