FSMA Implementation FDA s Preventive Controls Rules

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1 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

2 Presentation Overview FSMA Implementation Rulemaking and Industry Guidance - Focus on the Preventive Controls Rules FSMA Implementation Guiding Principles - Industry Training and Technical Assistance - Regulator Training and Resources 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 Apr 5, 2016 Intentional Adulteration Dec 24, 2013 May 27, 2016 * Supplemental proposals published September 2014 Final rule publication date 4

5 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (PCHF) Originally proposed: January 16, 2013 Supplemental proposal: September 29, 2014 Public comments: >8,000 for the original proposal >1,300 for the supplemental proposal Final rule: published September 17,

6 Who is Covered by PCHF Rule? Facilities that manufacture, process, pack or hold human food In general, facilities required to register with FDA under sec. 415 of the FD&C Act Not farms or retail food establishments Applies to domestic & imported food Some exemptions & modified requirements apply 6

7 What does PCHF Rule do? Establishes new requirements for hazard analysis & risk-based preventive controls Modernizes longstanding current good manufacturing practice (CGMP) requirements 7

8 Updated Human Food Current Good Manufacturing Practices Protection against allergen cross-contact Updated language (e.g., must instead of shall ) Certain provisions containing recommendations were deleted but others were made mandatory Previously nonbinding provisions, such as education and training, are now binding. GMPs for holding and distributing human food byproducts for use as animal food are new 8

9 Qualifications of Individuals Must have the education/ training/ experience necessary to manufacture, process, pack, or hold clean & safe food as appropriate to the individual s assigned duties Must receive training in the principles of food hygiene & food safety, as appropriate to the food, the facility & the individual s assigned duties Records of this training are required 9

10 Food Safety Plan Hazard analysis Preventive controls Supply-chain program Recall plan Procedures for monitoring Corrective action procedures Verification procedures 10

11 Food Safety Plan Hazard Analysis Hazard identification must consider known or reasonably foreseeable biological, chemical and physical hazards These could occur naturally, be unintentionally introduced, or be intentionally introduced for economic gain Hazard evaluation must consider severity of illness/injury and probability of occurrence in absence of preventive controls 11

12 Food Safety Plan Preventive Controls Measures required to ensure that hazards are significantly minimized or prevented. These include: Process controls Food allergen controls Sanitation controls Supply-chain controls Recall plan 12

13 Food Safety Plan Preventive Controls Include controls at critical control points (CCPs), if any, and controls other than those at CCPs that are appropriate for food safety Not required when hazard is controlled by another entity later in the distribution chain Disclose that food is for further processing Obtain written assurances hazard will be controlled 13

14 Food Safety Plan - Monitoring Facility must have written procedures, including the frequency they are to be performed, for monitoring the preventive controls (as appropriate to the nature of the preventive control) Monitoring must be documented in records subject to verification. 14

15 Food Safety Plan Corrective Actions and Corrections Facility must have written procedures for steps to be taken when preventive controls are not properly implemented Identify and correct a problem Reduce likelihood of occurrence Evaluate food for safety Prevent adulterated food from entering commerce 15

16 Food Safety Plan - Verification Includes (as appropriate to the facility, food and nature of the preventive control): Validation of preventive controls (process controls) Verification of monitoring and corrective actions Calibration of process monitoring and verification instruments Product testing, environmental monitoring Records review 16

17 Reanalysis of Food Safety Plan At least every three years Whenever there is a significant change that creates the potential for a new hazard When there is new information about potential hazards associated with a food When a preventive control is ineffective 17

18 What s New in a Food Safety Plan Element HACCP Plan Added in Food Safety Plan Hazard analysis Biological, chemical, physical Preventive controls CCPs for processes Parameters and values Critical limits Chemical hazards to include radiological; consider econ. motivated adulteration Process CCPs + controls at other points that are not CCPs Parameters and minimum/maximum values (= Critical limits for process controls) Monitoring Required for CCPs Required as appropriate for preventive controls Corrective actions or Corrections Verification Records Recall plan Corrective actions For process controls For process controls Not required in the plan Corrective actions or corrections, as appropriate As appropriate for all preventive controls; supplier verification required when supplier controls a hazard As appropriate for all preventive controls Required when a hazard requiring a preventive control is identified

19 PC Qualified Individual (PC QI) An individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system This individual maybe, but is not required to be, an employee of the establishment 19

20 Responsibilities of a PC QI Must do or oversee the following: Preparation of the food safety plan Validation of preventive controls Review of records Reanalysis 20

21 Supply-Chain Program Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt ( supply-chain applied control ). 21

22 Supply-Chain Program Requirements Use approved suppliers Determine supplier verification activities Conduct supplier verification activities Document supplier verification activities When applicable, verify a supply-chain-applied control applied by an entity other than your supplier

23 Supplier Verification Activities Onsite audits Sampling and testing Review of relevant food safety records Other as appropriate Activity and frequency based on nature of hazard, where it is controlled and supplier performance. 23

24 Onsite Audit Requirements For serious hazards requiring a supply-chainapplied control Documented onsite audit before using the raw material At least annually after the initial audit Exception You document that other verification activities or less frequent auditing provides adequate assurance

25 Onsite Audits Must be performed by a qualified auditor Government employee Third-party (e.g., agent of a certification body) Employee of receiving facility Inspection may substitute for audit in certain cases 25

26 Records Records required for subpart A Implementation records for subpart C (Document implementation of the food safety plan) Subpart F Requirements applying to records (Retention, use of existing records ) Records documenting the supply-chain program 26

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

27 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 27

28 Phase 2 FSMA Implementation Gaining and Maintaining Industry Compliance with FSMA Final Rules 28

29 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 29

30 Planned Guidance Documents (Human Food) Hazard analysis and preventive controls Environmental monitoring 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 30 30

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

31 Alliances Produce Safety Alliance (PSA) Centered at Cornell University Developing a curriculum to train the farming community Sprout Safety Alliance (SSA) Centered at the Illinois Institute of Technology Developing a curriculum to train sprout growers Food Safety Preventive Controls Alliance (FSPCA) Centered at the Illinois Institute of Technology Developing curricula to train those that manufacture, process, hold and distribute human and animal food 31

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

32 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 For course availability & Participant Manual 32

outreach and technical assistance for industry & regulators Part 1:

33 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 33

34 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 34

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36 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 36

37 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 37

38 FDA FSMA Technical Assistance Network Recent Process Improvements: Administrators have system licenses Summary TAN reports posted on web Auto-responses after 30/60 days Internal access database for all cleared TAN responses 38

39 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 39

2016 Sessions Every other month starting in February Recall Readiness February 26 Industry Third Party Audits April 22 Food Safety Culture 301 June 23 Sanitation

40 2016 Sessions Every other month starting in February Recall Readiness February 26 Industry Third Party Audits April 22 Food Safety Culture 301 June 23 Sanitation Essentials August 26 Application of Animal Food cgmps October 27 Intentional Adulteration December 15 Events for sharing industry best practices & FDA perspectives 40

41 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 41

42 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 42

43 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

44 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 44

45 Regulator Technical Assistance Electronic Resource Library 45

46 Public Information Web site: Subscription feature available To submit a question about FSMA, visit and go to Contact Us 46

Update on FSMA Implementation. Rebecca Buckner May 24, 2016

Update on FSMA Implementation. Rebecca Buckner May 24, 2016 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