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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.

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  1. Under the FDA's Food Safety Modernization Act, which rule specifically requires importers to verify that foreign food suppliers meet US food safety standards?

    Answer: Foreign Supplier Verification Program (FSVP)

    The FSVP rule requires US importers to perform risk-based activities to verify that imported food is produced in a manner that meets US safety standards.

  2. What is the primary regulatory concern with the use of mineral oil hydrocarbons (MOAH) migrating from recycled paperboard packaging into food?

    Answer: MOAH are potentially genotoxic and carcinogenic with no established safe exposure level

    Mineral oil aromatic hydrocarbons (MOAH) are of toxicological concern due to their potential genotoxic and carcinogenic properties, prompting regulatory scrutiny of recycled board.

  3. A packaging film contains a UV stabilizer that is not listed in 21 CFR. Under US law, which approach can a manufacturer use to demonstrate its safe use in food contact?

    Answer: Both A and B are valid regulatory pathways depending on concentration

    Both an FCN and a Threshold of Regulation exemption are valid pathways; the appropriate route depends on the expected dietary concentration and toxicological profile of the substance.

  4. Under 21 CFR Part 11, what does FDA require for electronic records and signatures used in food packaging quality systems?

    Answer: They must be trustworthy, reliable, and equivalent to paper records with proper controls and audit trails

    21 CFR Part 11 requires electronic records and signatures to be trustworthy, reliable, and equivalent to paper, with controls including audit trails, access controls, and system validations.

  5. Which packaging compliance requirement is specifically triggered when a food product is classified as an 'allergen-containing food' under the Food Allergen Labeling and Consumer Protection Act (FALCPA)?

    Answer: The label must declare the major food allergen by its common name in plain language

    FALCPA requires that major food allergens be declared on the label using the allergen's common or usual name in plain language, either in the ingredient list or in a 'Contains' statement.

  6. A cereal company discovers that their packaging converter used an adhesive laminate component not compliant with 21 CFR. Under FDA regulations, who bears regulatory responsibility?

    Answer: The food manufacturer (brand owner), as they are responsible for the safety of the finished food and its packaging

    Under US food law, the food manufacturer bears ultimate regulatory responsibility for ensuring all materials in contact with their food are compliant, regardless of where in the supply chain the error occurred.

  7. Which test method is most commonly used to determine the oxygen transmission rate (OTR) of a food packaging film, a critical parameter for food safety and shelf life?

    Answer: ASTM D3985 — coulometric sensor method at controlled temperature and humidity

    ASTM D3985 is the standard test method for oxygen gas transmission rate through plastic film and sheeting using a coulometric sensor.