Regulatory Framework & Compliance Flashcards

Which federal agency oversees the Food Safety Modernization Act (FSMA) Produce Safety Rule?

Answer: FDA Center for Food Safety and Applied Nutrition

The FDA's Center for Food Safety and Applied Nutrition (CFSAN) administers the FSMA Produce Safety Rule.

Under FSMA's Produce Safety Rule, which of the following commodities is explicitly excluded from coverage?

Answer: Grain crops such as wheat and corn

Grains, beans, and other commodities rarely consumed raw are excluded from the Produce Safety Rule.

A farm that averages less than $25,000 in annual produce sales is classified under FSMA as:

Answer: A non-covered farm

Farms with average annual produce sales of $25,000 or less are not covered by the Produce Safety Rule.

Which provision of FSMA specifically addresses preventive controls for human food at food facilities?

Answer: Section 103 — Hazard Analysis and Risk-Based Preventive Controls

Section 103 of FSMA established the Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirements for human food facilities.

State departments of agriculture that enter into cooperative agreements with the FDA to enforce the Produce Safety Rule are known as:

Answer: Authorized State Programs

States with FDA-authorized programs can conduct inspections on behalf of FDA under cooperative agreements.

Under GAP audit standards, what is the primary purpose of a corrective action report (CAR)?

Answer: To record and resolve identified food safety deficiencies

Corrective action reports document identified deficiencies and the steps taken to resolve them to prevent recurrence.

Which regulation requires that imported produce meet the same food safety standards as domestically grown produce under FSMA?

Answer: The Foreign Supplier Verification Program (FSVP) rule

FSMA's Foreign Supplier Verification Program requires importers to verify that foreign suppliers meet U.S. food safety standards.