Regulatory Compliance & Food Safety Flashcards
7 cards from real CPT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Food Safety flashcards as text
The FDA Food Safety Modernization Act (FSMA) shifted food safety regulation from a primarily reactive to what type of approach?
Answer: Preventive
FSMA shifted FDA's regulatory focus from responding to foodborne illness outbreaks to preventing them from occurring.
Which FSMA rule specifically addresses intentional adulteration of food, including through tampered packaging?
Answer: Intentional Adulteration Rule (21 CFR Part 121)
21 CFR Part 121, the Intentional Adulteration Rule, requires food facilities to identify and mitigate vulnerabilities to deliberate contamination.
Bisphenol A (BPA) migration from packaging into food is most likely to be a concern with which packaging material?
Answer: Polycarbonate and epoxy-lined cans
BPA is a monomer used in polycarbonate plastics and epoxy resins commonly applied as can liners, making these the primary migration concern.
Under the California Proposition 65 framework, what obligation does a business have when a packaging chemical exceeds the established threshold?
Answer: Provide a clear and reasonable warning to consumers before exposure
Proposition 65 requires businesses to provide consumers with clear warnings before knowingly exposing them to listed chemicals above safe harbor levels.
What is the significance of the SML (Specific Migration Limit) in food packaging regulation?
Answer: It sets the maximum permitted concentration of a specific substance in the food or food simulant
The SML is the maximum permitted amount of a specific chemical that can migrate from packaging into food under regulated test conditions.
Which body publishes the Generally Recognized as Safe (GRAS) list used in evaluating food contact substance safety in the United States?
Answer: FDA (Food and Drug Administration)
FDA administers the GRAS program, including the voluntary GRAS notification process for substances used in food and food packaging.
A packaging technologist is validating a new ink for direct food contact printing. Which regulatory pathway is most appropriate in the US?
Answer: Confirm the ink components comply with 21 CFR Part 175 (indirect food additives — adhesives and components of coatings)
Inks and coatings used in food packaging are regulated as indirect food additives under 21 CFR Part 175, which covers adhesives and coating components.