USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
CPSC If the CPSC makes a preliminary determination that a product defect creates a substantial risk of injury, corrective action is required. It clas - sifies product dangers depending on the likeli - hood and severity of death, injury or illness as either Class A, Class B or Class C Hazards. Each Hazard Class requires corrective action, which may include a recall, public notice and remedies for consumers. Corrective action may also include steps to mitigate a potential haz - ard, such as changes to design, manufacturing materials, quality control, warnings or marketing, or discontinuing a product. Companies must work with the CPSC to prepare a plan for communicating a recall to consumers. Requirements for recall notices are set forth in CFR Title 16, Section 1115.27. The CPSC has established the Fast-Track Product Recall Pro - gram, under which a company may avoid a pre - liminary determination by the CPSC that a prod - uct creates a substantial risk of injury if it reports the potential defect, meets other requirements for a timely recall, and works with the CPSC to implement a corrective action plan. FDA The FDA corrective action is largely voluntary and consists of either correction or recall. The FDA evaluates a potential health hazard based on factors set forth in CFR Title 21, Section 7.41, and assigns a recall classification (Class I, II or III) indicating the product’s relative degree of health hazard. Classes are assigned based on the like - lihood and seriousness of a product’s adverse health impact. The company then submits a proposed recall strategy to the FDA consistent with the requirements set forth in CFR Title 21, Section 7.42, and communicates the correc - tion or recall to consumers consistent with the requirements set forth in CFR Title 21, Section
7.49. The FDA will notify the public through its weekly Enforcement Report. See CFR Title 21, Section 7.50. NHTSA The NHTSA requires manufacturers to recall motor vehicles and component parts that fail to comply with FMVSS or that contain safety- related defects that pose an unreasonable risk to motor vehicle safety. Manufacturers have three options for correcting a defect: repair, replace or refund. If a recall is required, manufacturers must notify by first-class mail all registered own - ers and purchasers of the affected vehicles or components. The requirements for notification are set forth in CFR Title 49, Section 577.5. 1.4 Obligations to Notify Regulatory Authorities The notification requirements concerning poten - tial protect safety issues vary by agency. CPSC The CPSC mandates risk-based and incident- based reporting. Section 15 of the CPSA requires manufacturers, importers, distributors and retailers to notify the CPSC immediately if they receive information that reasonably sup - ports the conclusion that a product: • fails to comply with an applicable CPSC safety rule or law enforced by the CPSC; • contains a defect that could create a substan - tial product hazard; or • creates an unreasonable risk of serious injury or death. Section 15 reporting requirements are found in CFR Title 16, Section 1115. Section 102 of the Child Safety Protection Act requires companies to report certain choking incidents involving children. Code of Federal Regulations Title 16,
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