By Georgia D. Koutouzos, J.D.
Final rule limits the presence of harmful substances in toys and other child-care articles.
The U.S. Consumer Product Safety Commission (CPSC) issued a final rule determining that certain unfinished manufactured fibers do not contain the ASTM F963 elements or specified phthalates that exceed the limits set forth under the applicable statutes and regulations for children’s toys and child-care articles. Based on these determinations, the specified unfinished manufactured fibers would not be required to have third-party testing for compliance with the requirements of the ASTM F963 elements or phthalates for children’s toys and child-care articles (CPSC Final Rule, 85 FR 33015, June 1, 2020).
Phthalates concentrations. In October 2019, CPSC proposed that certain unfinished manufactured fibers do not contain any of the specified ASTM F963 elements in excess of specified concentrations or any of the specified phthalates in concentrations greater than 0.1 percent (1000 ppm) [see Products Liability Law Daily’s October 9, 2019 analysis]. An unfinished fiber is one that has no chemical additives beyond those required to manufacture the fiber. Unlike naturally occurring fibers, manufactured fibers can have chemicals added before fiber formation to impart color or some desirable performance property, such as flame retardancy. For unfinished fibers as described in the final rule, the unfinished fiber is free of these chemical additives.
The final rule, which is unchanged from the text of the October 2019 proposal, determines that the specified unfinished manufactured fibers do not contain any of the ASTM F963 elements in excess of specified concentrations, or any of the phthalates (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, and DCHP) prohibited by statute or regulation in concentrations greater than 0.1 percent.
New Part 1253. The action creates a new part 1253, "Children’s Toys and Child Care Articles: Determinations Regarding the ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers," which takes effect on July 1, 2020. Section 1253.1 (a) of the rule explains the statutorily created requirements for limiting the ASTM F963 elements in children’s toys under the Consumer Product Safety Improvement Act (CPSIA) of 2008 and the third-party testing requirements for children’s toys, while section §1253.1 (b) explains the statutory and regulatory requirements limiting phthalates for children’s toys and child-care articles under the CPSIA as well as the third-party testing requirements for children’s toys and child-care articles.
Section 1253.2 (a) of the rule provides a definition of the term "unfinished manufactured fiber" that applies to part 1253; §1253.2 (b) establishes the Commission’s determinations that specified unfinished manufactured fibers do not exceed the solubility limits for ASTM F963 elements with a high degree of assurance as that term is defined in 16 CFR part 1107; and §1253.2 (c) establishes the agency’s determinations that specified unfinished manufactured fibers do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107.
Finally, §1253.2 (d) of the rule states that accessible component parts of children’s toys and child-care articles made with the specified unfinished manufactured fibers specifically listed in the determinations in §1253.3 (b) and (c) are not required to be third-party tested pursuant to section 14 (a) (2) of the Consumer Product Safety Act (CPSA) and 16 CFR part 1107, while §1253.2 (e) states that accessible component parts of children’s toys and child-care articles that are not specifically listed in the determinations in §1253.3 (b) and (c) are required to be third-party tested pursuant to section 14 (a) (2) of the CPSA and 16 CFR part 1107.
Potentially affected products. A review by the CPSC Staff showed that comprehensive estimates of the number of children’s toys and child-care articles that contain component parts made from the specified unfinished manufactured fibers are not available. Based on the number of domestic producers and sellers of these products, however, the Staff believes that a substantial number of small entities could be impacted by the new regulation.
The review indicates that there might be close to 10,000 small firms that supply children’s toys or child-care articles with unfinished manufactured fibers in accessible component parts. Even if only a small proportion of these firms manufacture or sell products using the unfinished manufactured fibers of interest, a substantial number would benefit from the reduced testing burden, the agency said, adding that the impact of the determinations on small businesses would be to reduce the burden of third-party testing for firms and are expected to be entirely beneficial.
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