Regulatory Compliance & Legal Framework Flashcards
7 cards from real CPP 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 & Legal Framework flashcards as text
The Toxic Substances Control Act (TSCA) Section 5 requires manufacturers to submit a Premanufacture Notice (PMN) to EPA for new chemical substances at least:
Answer: 90 days before manufacture or import
TSCA Section 5 requires a 90-day PMN submission to EPA before manufacturing or importing a new chemical substance not already on the TSCA Chemical Substance Inventory.
Under the Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002), food packaging facilities must:
Answer: Register with the FDA and maintain records for traceability
The Bioterrorism Act requires food facilities to register with FDA and maintain records that allow tracing food and packaging one step forward and one step back in the supply chain.
When a U.S. packaging manufacturer exports goods to Canada, which Canadian regulation governs food packaging safety and labeling equivalents to FDA requirements?
Answer: Food and Drugs Act administered by Health Canada
Canada's Food and Drugs Act, administered by Health Canada, governs the safety of food contact materials and food labeling requirements parallel to U.S. FDA regulations.
A packaging company is audited for compliance with the Toxic Release Inventory (TRI) program under SARA Title III. TRI reporting is triggered when:
Answer: A facility manufactures, processes, or otherwise uses listed chemicals above threshold quantities
TRI reporting is required when a covered facility manufactures or processes ≥25,000 lbs, or otherwise uses ≥10,000 lbs, of a listed toxic chemical annually.
The U.S. model toxics in packaging legislation (based on the Coalition of Northeastern Governors model bill) prohibits intentional introduction of which four heavy metals in packaging?
Answer: Lead, mercury, cadmium, and hexavalent chromium
The model legislation (enacted in most U.S. states) prohibits intentional addition of lead, mercury, cadmium, and hexavalent chromium, with a combined incidental concentration limit of 100 ppm.
Under FDA regulations, when a food packaging supplier provides a 'letter of guarantee' to a food manufacturer, it serves to:
Answer: Transfer regulatory responsibility and represent compliance with food additive regulations
A letter of guarantee from a packaging supplier represents that the materials comply with applicable FDA regulations, shifting regulatory responsibility to the supplier if the guarantee is false.
The USDA's Agricultural Marketing Service (AMS) regulates packaging for which category of products?
Answer: Organic agricultural products bearing the USDA Organic seal
AMS administers the National Organic Program (NOP), which sets standards for organic certification including requirements for packaging materials used with USDA Organic-labeled products.