CPT Regulatory Compliance & Food Safety 3 — Questions and Answers
Question 1: The FDA Food Safety Modernization Act (FSMA) shifted food safety regulation from a primarily reactive to what type of approach?
- Preventive (Correct answer)
- Punitive
- Corrective
- Descriptive
Correct answer: Preventive
FSMA shifted FDA's regulatory focus from responding to foodborne illness outbreaks to preventing them from occurring.
Question 2: Which FSMA rule specifically addresses intentional adulteration of food, including through tampered packaging?
- Intentional Adulteration Rule (21 CFR Part 121) (Correct answer)
- Foreign Supplier Verification Program (FSVP)
- Preventive Controls for Human Food (21 CFR Part 117)
- Produce Safety Rule (21 CFR Part 112)
Correct 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.
Question 3: Bisphenol A (BPA) migration from packaging into food is most likely to be a concern with which packaging material?
- Polycarbonate and epoxy-lined cans (Correct answer)
- High-density polyethylene (HDPE) bottles
- Aluminum foil laminates
- Kraft paper bags
Correct 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.
Question 4: Under the California Proposition 65 framework, what obligation does a business have when a packaging chemical exceeds the established threshold?
- Provide a clear and reasonable warning to consumers before exposure (Correct answer)
- Immediately reformulate the packaging and notify FDA within 30 days
- Obtain a Prop 65 exemption certificate from the state of California
- Submit the product for third-party toxicology testing at an approved lab
Correct 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.
Question 5: What is the significance of the SML (Specific Migration Limit) in food packaging regulation?
- It sets the maximum permitted concentration of a specific substance in the food or food simulant (Correct answer)
- It defines the minimum wall thickness for rigid plastic containers
- It specifies the maximum label coverage area on a primary package
- It establishes the shelf life minimum for packaged perishable foods
Correct 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.
Question 6: Which body publishes the Generally Recognized as Safe (GRAS) list used in evaluating food contact substance safety in the United States?
- FDA (Food and Drug Administration) (Correct answer)
- USDA (U.S. Department of Agriculture)
- EPA (Environmental Protection Agency)
- CPSC (Consumer Product Safety Commission)
Correct 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.
Question 7: A packaging technologist is validating a new ink for direct food contact printing. Which regulatory pathway is most appropriate in the US?
- Confirm the ink components comply with 21 CFR Part 175 (indirect food additives — adhesives and components of coatings) (Correct answer)
- Register the ink as a direct food additive under 21 CFR Part 70
- Submit a color additive petition under 21 CFR Part 81
- Obtain USDA FSIS approval under 9 CFR Part 317
Correct 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.
CPT Regulatory Compliance & Food Safety 3
The FDA Food Safety Modernization Act (FSMA) shifted food safety regulation from a primarily reactive to what type of approach?