Intentional Adulteration (food defense) rule

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FSMA rule United States federal regulation food defense regulation

The Intentional Adulteration (food defense) rule is a U.S. FDA regulation that requires certain food facilities to implement preventive measures and vulnerability assessments to protect the food supply from acts of intentional contamination intended to cause widespread public harm.

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Statements (49)

Predicate	Object
instanceOf	FSMA rule ⓘ United States federal regulation ⓘ food defense regulation ⓘ
CFRLocation	21 CFR Part 121 ⓘ
complianceDate	2019 for large businesses ⓘ 2020 for small businesses ⓘ 2021 for very small businesses subject to modified requirements ⓘ
country	United States of America ⓘ surface form: United States
effectiveDate	2016 ⓘ
enforcementDiscretion	FDA announced phased enforcement and discretion for certain requirements ⓘ
exemption	alcoholic beverages under certain conditions ⓘ farms ⓘ food for animals ⓘ food for personal consumption ⓘ food for research or evaluation ⓘ food produced by the U.S. Department of Agriculture regulated facilities under certain conditions ⓘ very small businesses as defined by the rule ⓘ
focus	acts of intentional adulteration intended to cause wide-scale public health harm ⓘ vulnerabilities in bulk liquid receiving and loading ⓘ vulnerabilities in liquid storage and handling ⓘ vulnerabilities in mixing and similar activities ⓘ vulnerabilities in secondary ingredient handling ⓘ
legalBasis	Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ Food Safety Modernization Act NERFINISHED ⓘ
methodology	requires consideration of ability of an attacker to successfully contaminate the product ⓘ requires consideration of degree of physical access to product ⓘ requires use of a vulnerability assessment method that considers severity and scale of potential harm ⓘ
officialName	Mitigation Strategies to Protect Food Against Intentional Adulteration ⓘ
purpose	to protect the food supply against intentional contamination intended to cause widespread public health harm ⓘ to require food defense measures at vulnerable points in the food production process ⓘ
regulator	U.S. Food and Drug Administration NERFINISHED ⓘ
relatedConcept	food defense ⓘ food safety modernization ⓘ
relatedRegulation	Foreign Supplier Verification Programs rule NERFINISHED ⓘ Preventive Controls for Human Food rule NERFINISHED ⓘ
requires	facility-level vulnerability assessment ⓘ food defense corrective action procedures ⓘ food defense monitoring procedures ⓘ food defense verification activities ⓘ identification of actionable process steps ⓘ implementation of mitigation strategies at actionable process steps ⓘ reanalysis of the food defense plan ⓘ recordkeeping for food defense activities ⓘ training of personnel assigned to vulnerable areas or mitigation strategies ⓘ written food defense plan ⓘ
scope	certain foreign food facilities that export food to the United States ⓘ domestic food facilities required to register with FDA under section 415 of the FD&C Act ⓘ
shortName	IA rule ⓘ Intentional Adulteration rule NERFINISHED ⓘ

Referenced by (1)

Full triples — surface form annotated when it differs from this entity's canonical label.

Food Safety Modernization Act of 2011 → keyProvision → Intentional Adulteration (food defense) rule ⓘ