Update on FSMA Implementation

Rebecca Buckner

May 24, 2016

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

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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

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Phase 1: Standard Setting

*Supplemental proposals published September 2014 ◊Final rule publication date 4

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

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

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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

Phase 2 FSMA Implementation

Gaining and Maintaining Industry Compliance with FSMA Final Rules

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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

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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

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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 Process Preventive Controls

Food Safety Plan Overview Food Allergen Preventive Controls

GMPs and Prerequisite Programs Sanitation Preventive Controls

Biological Food Safety Hazards Supplier Preventive Controls

Chemical, Physical and Economically Motivated Food Safety Hazards

Verification and Validation Procedures

Preliminary Steps Record-keeping Procedures

Resources for Preparing a Food Safety Plan

Recall Plan

Hazard Analysis and Preventive Control Determination

Regulation Overview

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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

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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

www.fda.gov/fsma and go to Contact Us

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Technical Assistance for Industry Collaboration with FSPCA

Preventive Controls Scientific & Technical Questions from Industry – a web form at:

www.iit.edu/ifsh/alliance

FSMA Regulation & Policy Interpretation Questions – a web form at:

www.fda.gov/fsma

ORA

CVM

OIP

CFSAN

KMS

Extension Specialists

Land Grant Universities

International Partners

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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 www.fda.gov/fsma

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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

Key Implementation Principles

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FSMA Rule Readiness Training 2016 Sessions

Every other month • Recall Readiness – February • Third Party Audits – April • Food Safety Culture 301 – June • Sanitation Essentials – August • Application of Animal Food cGMPs – October • Intentional Adulteration – December

Events for sharing industry best practices & FDA perspectives

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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

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PCHF Regulator Specific Training

• Curriculum Development – Modernized Human Food CGMP Webinar

– Regulator Train the Trainer Course

– Regulator Participants Course

• Training Delivery – phased in FY 2016 -18 – Train the Trainers & Instructor Cadre

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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

FY17-19

FDA PC Regulator Training

Delivery Model

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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

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Other FSMA rulemakings • Implementation for the other six FSMA

rulemaking will generally follow the same principles. – Guidance documents – Alliances – Technical Assistance Network – Regulator Education

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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

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Public Information • Web site: www.fda.gov/fsma • Subscription feature available • To submit a question about FSMA, visit

www.fda.gov/fsma and go to Contact Us

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