The duty to report a substantial product hazard and how fast it runs, voluntary corrective action plans and mandatory recalls, banned hazardous substances, children's product certification and testing, lead and small-parts rules, resale of recalled goods, and civil penalties.
A manufacturer of a children's product must place permanent distinguishing marks on the product and its packaging, to the extent practicable, that enable the manufacturer to ascertain the location and date of production and cohort information such as a batch or run number, and enable an ultimate purchaser to determine the source, the date of production and detailed information about the manufacturing process. The mark supports recall targeting and consumer identification.
A voluntary corrective action is a negotiated plan agreed with staff and publicly announced. A mandatory recall requires the Commission to determine, after affording interested persons an opportunity for a hearing, that a product distributed in commerce presents a substantial product hazard and that notification or remedy is in the public interest. The compulsory route offers procedural protections the negotiated route does not, at the cost of time, cost and publicity.
It is a prohibited act to sell, offer for sale, distribute in commerce or import a consumer product that is subject to a voluntary corrective action taken in consultation with the Commission and publicly announced, or subject to an order requiring notification or remedy. The same prohibitions apply to banned hazardous products and banned hazardous substances. Liquidation, clearance and secondhand channels are the routes through which recalled stock most often reappears.
Two statutes supply banning power. Under the hazardous substances law, an article may be declared a banned hazardous substance where it is so hazardous that adequate cautionary labeling cannot be written, or where it is intended for children and its hazard cannot be addressed by labeling. Under the product safety law, a product may be declared a banned hazardous product where no feasible standard would adequately protect the public. Both operate by rule and reach the whole distribution chain.
A firm must immediately inform the Commission when it obtains information reasonably supporting the conclusion that a product fails to comply with a rule, contains a defect that could create a substantial product hazard, or creates an unreasonable risk of serious injury or death. Immediately means within twenty-four hours. A reasonable investigation is permitted first but should not exceed ten days, and knowledge held by an employee who could appreciate it is imputed to the firm.
A voluntary corrective action plan is a negotiated document in which a firm undertakes to notify identified audiences, provide a stated remedy, account for units in the distribution chain, and report progress on a fixed cycle. It carries no admission requirement but is enforceable in practice, because selling a product subject to a publicly announced voluntary corrective action is a prohibited act. The plan closes only when the Commission accepts that the undertakings are complete.
Accessible component parts of children's products may not contain more than one hundred parts per million total lead content by weight, and paint or similar surface coating on children's products or furniture may not exceed a far lower limit. Toys and other articles intended for children under three must not fit entirely within a specified cylinder, before or after use and abuse testing. Which requirements apply turns on the age grading of the product.
The effectiveness of a recall is measured by the proportion of distributed units that are corrected, returned or destroyed. Direct notice to identified purchasers produces far higher response than public announcement alone, and the remedy design controls whether consumers act. Firms report progress on a fixed cycle, and a low response rate prompts additional notice rather than closure of the corrective action.
A knowing violation of the prohibited acts provision carries a civil penalty for each violation, with each product ordinarily constituting a separate offense and a ceiling for any related series, both adjusted for inflation by rule. Knowing includes knowledge obtainable by exercising due care. The amount is set using statutory factors about the violation and additional factors covering the firm's safety and compliance program, history of noncompliance, economic gain and responsiveness.
A defect is a fault, flaw or irregularity that causes weakness, failure or inadequacy in form or function, and it may arise from design, composition, construction, packaging, warnings or instructions. Whether a defect creates a substantial product hazard depends on the pattern of the defect, the number of products distributed, the severity of the risk and the exposure of vulnerable populations. A product can be defective without violating any mandatory standard.
Every children's product subject to a children's product safety rule requires a Children's Product Certificate based on testing by a third party conformity assessment body accepted by the Commission for that rule. Certification is followed by periodic testing at intervals that depend on whether the manufacturer runs a production testing plan or uses an accredited laboratory, and by retesting after any material change.
