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Food Safety Modernization Act (FSMA): International Adulteration

Larisa PavlickVP, Global Regulatory & ComplianceUnited Natural Products Alliance

June 12, 2019

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Who is UNPA?

Food Safety Modernization Act (FSMA) and the seven foundational rules including:

• Preventive Controls for Human Food (PCHF)

• Foreign Supplier Verification Programs (FSVP)

• Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule)

Key words: modernization, prevention, proactive, science and risk based

Why is FSMA important?

• What is required to be compliant with the IA Rule?

• Responsibilities of Food Defense Qualified Individual

• Food Defense Plan

• Vulnerability Assessment and Mitigation Strategies

• Resources

FSMA: Intentional Adulteration Rule

Intentional Adulteration Rule

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What?• “…aimed at preventing

intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.”

• 21 CFR Part 121• Docket ID: FDA-2018-D-1398 https://www.fda.gov/media/98085/download

FDA Guidance Document

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Acts of IA may include:• Acts intended to cause wide scale public

health harm• Terrorism focused on the food supply• Disgruntled employees• Consumers• Competitors• Economically Motivated Adulteration (EMA)

IA Rule

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Key Provisions:1. Establish and implement a required Food Defense Plan

• Written • Like a HACCP evaluation or PCHF - Food Safety Plan• Evaluation and control of food safety hazards and strengthen

necessary safeguards

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Four Subparts: A: General

B: ReservedC: Food Defense Measures

D: RecordsE: Compliance

Applicability (21 CFR Part 121.1)

• Domestic or foreign food facility• Manufacture, process, pack or hold food for consumption in the U.S.• If required to register with the FDA-Food Facility Registration (FFR)

FFR via the FDA electronic portalhttps://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities

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Exemptions (21 CFR Part 121.5)

a) Very Small business. Modified requirements.b) Holding of food, except liquid storage tanksc) Packing, repacking, labeling, or re-labeling if in intact finished

product packaging. For example: into master cartonsd) Farm activitiese) Alcoholic beveragesf) Animal foodg) On-farm manufacturing activities for eggs or game meat.

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Subpart C: Food Defense Measures

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• FDP• Vulnerability Assessment (VA)• Mitigation Strategies (MS)• Monitoring

• Corrective Action• Verification• Reanalysis

Subpart C: Food Defense Measures

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121.126 (b): Contents of a FDP

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1. Written Vulnerability Assessment2. Written Mitigation strategies3. Written procedures for FD monitoring4. Written procedures for corrective actions5. Written procedures for verification

Subpart E: Compliance (21 CFR Part 121.401)

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• Section 420: Protection against intentional adulteration• Subpart C: Food Defense Measures• Subpart D: Records

Failure equals FDA regulatory consequences

FDA Guidance Document

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration

Published initially June 2018 March 2019…with an additional 65 pages for a total of 159!

FDA Guidance Document

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• FDA Guidance documents are not legally binding or enforceable responsibilities.

• “…our current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.”

• Once completed it will include nine chapters and four appendix

FDA Guidance Document

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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-mitigation-strategies-protect-food-against-intentional-adulteration

• Chapter 1: Food Defense Plan• Chapter 2: Vulnerability Assessment• Chapter 3: Mitigation Strategies (MS)• Chapter 4: MS Monitoring• Chapter 8: Training• Appendix 1: FDP Worksheets • Appendix 4: VA Examples

FDA: Food Defense Plan Builder

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https://www.accessdata.fda.gov/scripts/fdplanbuilder/

Intentional Adulteration Rule

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https://www.regulations.gov/document?D=FDA-2018-D-1398-0025

Mitigation Strategies To Protect Food Against Intentional

Adulteration: Draft Guidance for Industry; Public Meeting

Compliance Dates

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Very Small Small Other

< $10,000,000 sales and inventory per year in

human food sales average for three years

prior to compliance date

< 500 employees including all

subsidiaries and affiliates

All others • > $10,000,000 in

sales • >500 employees

Compliance Dates

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Federal Register Publication Date:

May 27, 2016

Very Small Small Other

5 years 4 years 3 years

< $10,000,000 < 500 employees All others

July 26, 2021 July 27, 2020 July 26, 2019

Intentional Adulteration Rule

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Intentional Adulteration Rule

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Subpart A: General Provisions21 CFR Part 121.4: Qualifications of Individuals

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Subpart C (Food Defense Measures)

Applicability (21 CFR Part 121.4)

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QI Requirements

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• Received training in food defense awareness• Record of qualifications: background, education, training,

and experience• Successfully completed training for specific function and

including the “standardized curriculum”• Prepares food defense plan• Conducts vulnerability assessment• Identify and explain mitigation strategies• Reanalysis of this plan

Three Fundamental Elements of VA

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1.Potential public health impact if a contaminant were added2.Degree of physical access to the product3.Ability of an attacker to successfully contaminate the product

121.130(a)(1). (a)(2), and (a)(3)

Key Activity Types

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• FDA developed method based on analysis of 50 vulnerability assessments

• Identify actionable processing steps

Most vulnerable, regardless of food commodity:• Bulk Liquid receiving and loading• Liquid storage and handling• Secondary ingredient handling• Mixing and similar activities

Three VA Methods

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1. Key Activity Types: quick, clean, and efficient2. Create your own: using three functional elements 3. Hybrid: Combo of create your own and KAT

FSPCA

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https://www.ifsh.iit.edu/sites/ifsh/files/departments/fspca/pdfs/FSPCA_IAVA_PARTICIPANT%20MANUAL_FINAL_V1.0_PUBLIC%20VERSION_2019%2004%2015.pdf

https://www.ifsh.iit.edu/sites/ifsh/files/departments/fspca/pdfs/FSPCA_FORM_0035_IA-Course-Cheat-Sheet_19-05-20.pdf

USDA and FSIS and Food Defense

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https://www.fsis.usda.gov/wps/wcm/connect/53b140bf-8eca-41e6-95ef-6209f48c4371/Warehouse_Center_Checklist_2.pdf?MOD=AJPERES

Next steps:

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• Assign, train, document qualifications of your QI • Establish and implement your Food Defense Plan• Obtain free training online via FSPCA• FSPCA paid online courses• If necessary, obtain face to face training for Vulnerability

Assessment when not using KAT approach. • More soon from UNPA regarding VA course

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Food Safety Modernization Act (FSMA)

Intentional Adulteration Rule

• What is required to be compliant with the IA Rule

• Responsibilities of Food Defense QI

• Food Defense Plan

• Vulnerability assessment and Mitigation Strategies

• Resources

Why is FSMA important?

Questions?

Larisa E. PavlickUnited Natural Products Alliance

1075 E. Hollywood Ave.Salt Lake City, UT 84105

801.738.2975larisa@unpa.com

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