FDA Food Defense Activities in the U.S. and Abroad Ryan Newkirk, - - PowerPoint PPT Presentation

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fda food defense activities in the u s and abroad
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FDA Food Defense Activities in the U.S. and Abroad Ryan Newkirk, - - PowerPoint PPT Presentation

May 26, 2023 226 likes •470 views

FDA Food Defense Activities in the U.S. and Abroad Ryan Newkirk, PhD, MPH Senior Advisor for Intentional Adulteration FDA, CFSAN 1 Why should we protect against IA? In any country, intentional adulteration has the potential to cause:

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FDA Food Defense Activities in the U.S. and Abroad

Ryan Newkirk, PhD, MPH Senior Advisor for Intentional Adulteration FDA, CFSAN

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Why should we protect against IA?

  • In any country, intentional adulteration has

the potential to cause:

– Significant public health consequences – Widespread public fear – Devastating economic impacts – Loss of public confidence in the safety of food and effectiveness of governments – Disruption of trade

www.fda.gov

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Main Categories of FDA Food Defense Activities

  • Regulation and guidance

– Applies to domestic and foreign facilities required to register with FDA

  • Education and outreach

– Can be used by, and applied to, domestic and foreign entities

  • Tools and resources

– Can be used by, and applied to, domestic and foreign entities

www.fda.gov

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Regulation and Guidance:

Food Safety Modernization Act Rule “Mitigation Strategies to Protect Food Against Intentional Adulteration”

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Regulation: FSMA IA Rule

  • Establishes requirements to prevent or

significantly minimize acts intended to cause wide-scale public health harm

  • Coverage

– Domestic and foreign facilities, required to register with FDA, that manufacture, process, pack or hold human food

www.fda.gov

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Regulation: FSMA IA Rule

  • Very small businesses
  • Holding of food, except holding of food in liquid storage tanks
  • Packing, repacking, labeling, or relabeling of food where the

container that directly contacts the food remains intact

  • Activities of a farm subject to FSMA Produce Safety Rule
  • Manufacturing, processing, packing, or holding food for

animals

  • Alcoholic beverages at certain facilities (under specified

conditions)

www.fda.gov

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Regulation: FSMA IA Rule

  • Requirements

– Food defense plan

  • Vulnerability assessment
  • Mitigation strategies
  • Procedures for food defense monitoring
  • Food defense corrective action procedures
  • Food defense verification procedures
  • Reanalysis

– Training – Records

www.fda.gov

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Regulation: FSMA IA Rule

  • Compliance dates

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

www.fda.gov

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Guidance: IA Rule

  • 1st installment – published 6/18

– Background and definitions – Relatively simple and cost-effective method to identify vulnerable points (i.e., KAT Method) – 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

www.fda.gov

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Guidance: IA Rule

  • 2nd installment - published 3/19

– Identifying vulnerabilities in a way that includes an in-depth analysis and can be tailored to a facility (i.e., 3 Fundamental Elements)

– Identifying vulnerabilities in a way that combines strengths of KAT and 3 Element approaches (i.e., Hybrid Approach) – Education, training, or experience – Additional examples of worksheets – VA examples

www.fda.gov

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Guidance: IA Rule

  • 3rd installment

– Food defense corrective actions – Food defense verification – Reanalysis – Records – Appendices

www.fda.gov

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Education and Outreach

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Education, Training, or Experience: IA Rule

  • Individuals assigned to APSs

– Food defense awareness – flexibility – Proper implementation of mitigation strategy – flexibility

  • Food Defense Qualified Individuals

– Must be qualified to perform certain activities through education, training, or experience

  • Food Safety Preventive Controls Alliance (FSPCA)

– Working with FSPCA International Subcommittee

www.fda.gov

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Education, Training, or Experience

FSPCA Training Course Delivery Method Intended Audience

Food Defense Awareness

  • Workers at Actionable Process Steps (e.g., front

line food workers)

  • Supervisors of Workers at Actionable Process

Steps

  • Satisfies requirement in § 121.4(b)(2)

Overview of IA Rule

  • Any stakeholder interested in learning more

about the IA rule requirements

  • This course is not associated with any IA rule

training requirement

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Education, Training, or Experience

FSPCA Training Course Delivery Method Intended Audience – Food Professionals who do the following: Conducting Vulnerability Assessments (VAs) using Key Activity Types (KAT)

  • Conduct VAs using the KAT

Method only Conducting Vulnerability Assessments

  • Conduct VAs using the 3

Fundamental Elements

  • This 1-day course must be taught by

trained FSPCA VA Lead Instructors Identification and Explanation

  • f Mitigation Strategies
  • Identify Mitigation Strategies to

implement at Actionable Process Steps Food Defense Plan Preparation and Reanalysis

  • Prepare the Food Defense Plan
  • Conduct Reanalysis activities
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Education and Outreach

  • Public meetings
  • Conferences
  • Trade associations
  • Companies
  • Government interactions

www.fda.gov

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International Food Defense Collaborative Activity

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Food Defense Tools and Resources

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FDA Food Defense Plan Builder v1.0

www.fda.gov

  • Desktop software tool to assist food industry

with developing food defense plans

  • Released in 2013
  • Developed under voluntary food defense

framework – does not fully align with IA rule

  • Over 56,500 downloads from

all over the world

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FDA Food Defense Plan Builder v2.0

  • Updated content and functionality to align with

FDP requirements of the IA Rule

  • Conducted usability study with food industry

participants April 2019

  • New sections for monitoring, corrective actions,

verification procedures, signature, etc.

  • Coming soon!

www.fda.gov

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Mitigation Strategies Database

www.fda.gov

  • Assists in identifying mitigation strategies to

protect food against intentional adulteration

  • Provides a range of strategies for individuals to

consider implementing at points, steps or procedures to minimize the vulnerability to an intentional attack

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FREE-B Exercises

www.fda.gov

  • Food Related Emergency Exercise Bundle
  • Scenarios based on both intentional and

unintentional food contamination events

  • Assists agencies in assessing food emergency

response plans, protocols and procedures

  • Includes facilitator’s guide, a lead planner’s

guide and a situation manual

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Need more information?

www.fda.gov

  • FDA Food Defense
  • FDA FSMA IA Rule
  • FDA Technical Assistance Network