Intentional Adulteration (food defense) rule
E642129
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.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Intentional Adulteration (food defense) rule canonical | 1 |
| Intentional Adulteration rule | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T7111049 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Intentional Adulteration (food defense) rule Context triple: [Food Safety Modernization Act of 2011, keyProvision, Intentional Adulteration (food defense) rule]
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A.
Food Safety Modernization Act of 2011
The Food Safety Modernization Act of 2011 is a major U.S. law that shifted the nation’s food safety system toward preventing contamination rather than responding to outbreaks, expanding the FDA’s regulatory and enforcement powers over the food supply.
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B.
Centre for Collaboration with Food Safety Authorities
The Centre for Collaboration with Food Safety Authorities is a specialized unit within the Norwegian Institute of Public Health that coordinates research, expertise, and communication on food safety issues in partnership with national regulatory bodies.
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C.
United States Standards for Grades of Meat and Poultry
United States Standards for Grades of Meat and Poultry are official federal quality grading criteria that classify meat and poultry products based on factors like tenderness, juiciness, appearance, and yield to support fair trade and inform consumers.
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D.
New York State Shellfish Sanitation Program
The New York State Shellfish Sanitation Program is a regulatory and monitoring initiative that oversees the safety, harvesting, and handling of shellfish in the state’s marine and coastal waters to protect public health.
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E.
Poultry Products Inspection Act
The Poultry Products Inspection Act is a U.S. federal law that regulates the processing and labeling of poultry products to ensure they are safe, wholesome, and accurately represented to consumers.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Intentional Adulteration (food defense) rule Target entity description: 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.
-
A.
Food Safety Modernization Act of 2011
The Food Safety Modernization Act of 2011 is a major U.S. law that shifted the nation’s food safety system toward preventing contamination rather than responding to outbreaks, expanding the FDA’s regulatory and enforcement powers over the food supply.
-
B.
Centre for Collaboration with Food Safety Authorities
The Centre for Collaboration with Food Safety Authorities is a specialized unit within the Norwegian Institute of Public Health that coordinates research, expertise, and communication on food safety issues in partnership with national regulatory bodies.
-
C.
United States Standards for Grades of Meat and Poultry
United States Standards for Grades of Meat and Poultry are official federal quality grading criteria that classify meat and poultry products based on factors like tenderness, juiciness, appearance, and yield to support fair trade and inform consumers.
-
D.
New York State Shellfish Sanitation Program
The New York State Shellfish Sanitation Program is a regulatory and monitoring initiative that oversees the safety, harvesting, and handling of shellfish in the state’s marine and coastal waters to protect public health.
-
E.
Poultry Products Inspection Act
The Poultry Products Inspection Act is a U.S. federal law that regulates the processing and labeling of poultry products to ensure they are safe, wholesome, and accurately represented to consumers.
- F. None of above. chosen
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
ⓘ
linked to:
United States of America
|
| 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
ⓘ
Food Safety Modernization Act ⓘ
linked to:
Food Safety Modernization Act of 2011
|
| 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
ⓘ
linked to:
Food and Drug Administration
|
| relatedConcept |
food defense
ⓘ
food safety modernization ⓘ |
| relatedRegulation |
Foreign Supplier Verification Programs rule
ⓘ
linked to:
Foreign Supplier Verification Programs
Preventive Controls for Human Food rule ⓘ |
| 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 ⓘ
linked to:
Intentional Adulteration (food defense) rule
|
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Intentional Adulteration (food defense) rule Description of subject: 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.
Referenced by (2)
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
ⓘ
linked to: Intentional Adulteration (food defense) rule