Food Safety Modernization Act (FSMA): International ... · Food Safety Modernization Act (FSMA) and...
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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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…the greatest
collection of brilliant
minds!
UNPA © 2019
Who is UNPA?
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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?
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• 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
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Intentional Adulteration Rule
UNPA © 2019
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
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FDA Guidance Document
UNPA © 2019
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)
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IA Rule
UNPA © 2019
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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UNPA © 2019
Four Subparts: A: General
B: ReservedC: Food Defense Measures
D: RecordsE: Compliance
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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
UNPA © 2019
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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.
UNPA © 2019
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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
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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
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Subpart E: Compliance (21 CFR Part 121.401)
UNPA © 2019
• Section 420: Protection against intentional adulteration• Subpart C: Food Defense Measures• Subpart D: Records
Failure equals FDA regulatory consequences
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FDA Guidance Document
UNPA © 2019
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!
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FDA Guidance Document
UNPA © 2019
• 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
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FDA Guidance Document
UNPA © 2019
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
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FDA: Food Defense Plan Builder
UNPA © 2019
https://www.accessdata.fda.gov/scripts/fdplanbuilder/
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Intentional Adulteration Rule
UNPA © 2019
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
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Compliance Dates
UNPA © 2019
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
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Compliance Dates
UNPA © 2019
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
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Intentional Adulteration Rule
UNPA © 2018
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Intentional Adulteration Rule
UNPA © 2018
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Subpart A: General Provisions21 CFR Part 121.4: Qualifications of Individuals
UNPA © 2019
Subpart C (Food Defense Measures)
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Applicability (21 CFR Part 121.4)
UNPA © 2019
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QI Requirements
UNPA © 2019
• 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
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Three Fundamental Elements of VA
UNPA © 2019
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)
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Key Activity Types
UNPA © 2019
• 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
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Three VA Methods
UNPA © 2019
1. Key Activity Types: quick, clean, and efficient2. Create your own: using three functional elements 3. Hybrid: Combo of create your own and KAT
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FSPCA
UNPA © 2019
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
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USDA and FSIS and Food Defense
UNPA © 2019
https://www.fsis.usda.gov/wps/wcm/connect/53b140bf-8eca-41e6-95ef-6209f48c4371/Warehouse_Center_Checklist_2.pdf?MOD=AJPERES
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Next steps:
UNPA © 2019
• 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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UNPA © 2018
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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?
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Questions?
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Larisa E. PavlickUnited Natural Products Alliance
1075 E. Hollywood Ave.Salt Lake City, UT 84105
unpa.com© 2017 UNPA
Thank you!