Code of Federal Regulations Title 21. Food and Drugs § 21.121.157 Reanalysis

(1) Whenever a significant change made in the activities conducted at your facility creates a reasonable potential for a new vulnerability or a significant increase in a previously identified vulnerability;

(2) Whenever you become aware of new information about potential vulnerabilities associated with the food operation or facility;

(3) Whenever you find that a mitigation strategy, a combination of mitigation strategies, or the food defense plan as a whole is not properly implemented;  and

(4) Whenever FDA requires reanalysis to respond to new vulnerabilities, credible threats to the food supply, and developments in scientific understanding including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.

(1) Before any change in activities (including any change in mitigation strategy) at the facility is operative;

(2) When necessary within 90–calendar days after production;  and

(3) Within a reasonable timeframe, providing a written justification is prepared for a timeframe that exceeds 90 days after production of the applicable food first begins.