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Children's Products Containing Lead; Interpretative Rule on Inaccessible Component Parts (16 CFR 1500.87) — Commission ballot package: draft Federal Register notice, staff guidance memorandum, and response to public comments

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Overview

A fifty-two-page Consumer Product Safety Commission ballot package dated July 23, 2009 (ballot vote due July 30, 2009; rule effective August 14, 2009) containing the Commission’s draft Federal Register notice promulgating the final interpretative rule on inaccessible component parts of children’s products containing lead under Section 101(b)(2) of the Consumer Product Safety Improvement Act of 2008. The package codifies the rule at a new 16 CFR 1500.87 and consists of: (i) a two-page ballot vote sheet from CPSC Office of General Counsel (Philip Chao, Hyun S. Kim) routed through General Counsel Cheryl A. Falvey and Acting Executive Director Jacqueline Elder to the Commission and Secretary Todd A. Stevenson; (ii) Attachment 1, the thirty-page draft Federal Register notice (16 CFR Part 1500) reproducing the rule preamble (Background, Statutory Authority, Notice of Proposed Rulemaking, Discussion of Comments and Responses, Effective Date, List of Subjects, Conclusion) and the full regulatory text of §1500.87(a) through (j); (iii) Attachment 2, a five-page CPSC staff memorandum “Consumer Product Safety Improvement Act of 2008 (CPSIA) — Guidance for Evaluating Accessibility of Lead-Containing Component Parts” by Robert J. Howell and Kristina M. Hatlelid summarizing the proposed accessibility-assessment framework and the staff’s conclusions and recommendation to the Commission; and (iv) Attachment 3, a ten-page CPSC staff memorandum “Response to Public Comments: Inaccessibility of Lead-Containing Components of Children’s Products” by Kristina M. Hatlelid (through Lori E. Saltzman to Mary Ann Danello) cataloguing the nine public comments received on the January 15, 2009 notice of proposed rulemaking (74 FR 2439) and the staff’s responses, with Appendix A listing the commenters (Office of the Secretary memorandum from Todd A. Stevenson, February 24, 2009). The package contains no primary contamination measurements; it is included in the Heavy Metal Index corpus as the primary-regulatory-record source for the 16 CFR 1500.87 inaccessibility-exclusion framework that any HMTc certification of US children’s products covered by CPSIA must reckon with, and as the canonical citation for the statutory-interpretation reasoning the Commission adopted in distinguishing physical accessibility from leaching or ingestion-based accessibility.

Key numbers

  • CPSIA Section 101(a) lead-content limits for children’s products (Attachment 1, §1500.87(a), p. 28–29): products designed or intended primarily for children 12 and younger cannot contain more than 600 ppm of lead effective February 10, 2009; not more than 300 ppm effective August 14, 2009; the limit may be further reduced to 100 ppm on August 14, 2011, “unless the Commission determines that it is not technologically feasible to have this lower limit.”
  • “Children’s product” age scope (Attachment 1, p. 2; CPSA §3(a)(16) as amended by CPSIA §235(a)): “a consumer product designed or intended primarily for children 12 years of age or younger.”
  • Section 101(b)(2) inaccessibility exclusion (Attachment 1, §1500.87(b), p. 29): “the lead limits do not apply to component parts of a product that are not accessible to a child. This section specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product, as determined by the Commission.”
  • Section 101(b)(3) paint/coating/electroplating barrier prohibition (Attachment 1, p. 1 and §1500.87(b)): “Paint, coatings, or electroplating may not be considered to be a barrier that would render lead in the substrate to be inaccessible to a child.”
  • Rule-issuance deadline imposed by CPSIA Section 101(b)(2)(B) (Attachment 1, p. 1, §1500.87(c)): the Commission is required to issue this interpretative rule by August 14, 2009. The final rule was made effective on the deadline date (August 14, 2009).
  • Notice of Proposed Rulemaking citation (Attachment 1, p. 3): the proposed interpretative rule was published in the Federal Register of January 15, 2009 at 74 FR 2439. Public-comment period closed February 17, 2009; nine comments were received and addressed in Attachment 3.
  • Accessibility-probe regulations adopted (Attachment 1, §1500.87(d), p. 29–30): the accessibility probes specified for sharp points or edges under the Commission’s existing regulations at 16 CFR 1500.48–1500.49 will be used to assess accessibility of lead-containing component parts. “A lead-containing component part would be considered accessible if it contacts any portion of the specified segment of the accessibility probe.”
  • Use-and-abuse test regulations adopted, by age band (Attachment 1, §1500.87(e)–(h), p. 30–31):
    • 18 months of age or less → 16 CFR 1500.51 (excluding the bite test of 1500.51(c))
    • over 18 months but not over 36 months of age → 16 CFR 1500.52 (excluding the bite test of 1500.52(c))
    • over 36 months but not over 96 months of age → 16 CFR 1500.53 (excluding the bite test of 1500.53(c))
    • over 96 months through 12 years of age → 16 CFR 1500.53 intended for children aged 37–96 months (excluding the bite test of 1500.53(c))
  • Bite-test exclusion rationale (Attachment 1, §D.7, p. 19–20): the Commission “does not use the bite test specified in the three CFR sections, as a result of a court case (Clever Idea Co., Inc. v. Consumer Products Safety Commission, 385 F. Supp. 688 (E.D. N.Y. 1974)) that questioned the appropriateness of this test. This requirement may be modified in a future proceeding.”
  • Fabric-covering rule (Attachment 1, §1500.87(i), p. 31): “A children’s product that is or contains a lead-containing part which is enclosed, encased, or covered by fabric and passes the appropriate use and abuse tests on such covers, is inaccessible to a child unless the product or part of the product in one dimension is smaller than 5 centimeters.” The 5-cm threshold is imported from CPSIA Section 108(e)(2)(B) (“if a toy or part of toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth”), applied here by analogy to children’s products beyond toys.
  • Intentional disassembly carve-out (Attachment 1, §1500.87(j), p. 31): “The intentional disassembly or destruction of products by children older than age 8 years by means or knowledge not generally available to younger children, including use of tools, will not be considered in evaluating products for accessibility of lead-containing components.”
  • Companion CPSIA Section 101 rules cited in the preamble (Attachment 1, p. 11–12, 15, 26–27):
    • 74 FR 6990 (February 12, 2009): interim final rule providing exemptions for certain electronic devices for which it is not technologically feasible to comply with the lead content limits.
    • 74 FR 10475 (March 11, 2009): final rule establishing procedures for a Commission determination that a specific material or product does not exceed the lead content limits specified under Section 101(a) of the CPSIA.
    • 74 FR 2433 (January 15, 2009): notice of proposed rulemaking on lead-content limits for certain materials or products preliminarily determined to fall below the lead content limits.
  • Statutory authority cited (Attachment 1, p. 28): the authority for 16 CFR Part 1500 as amended reads “15 U.S.C. 1261–1278, 122 Stat. 3016.” The 122 Stat. 3016 citation is Public Law 110-314 (CPSIA, 2008).
  • List of Subjects in 16 CFR Part 1500 (Attachment 1, p. 28): “Consumer protection, Hazardous materials, Hazardous substances, Imports, Infants and children, Labeling, Law enforcement, and Toys.”
  • Compact-disk/DVD interpretation (Attachment 1, §D.11, p. 26–27; Attachment 3, p. 7): “Acrylic polymer layers of a compact disk or DVD are not considered to be a coating. If the internal metallic layer of a disk is not accessible to a child, testing and certification would not be required.” The staff explicitly distinguishes the acrylic polymer layer of a CD/DVD from “paint, coatings, or electroplating” within the meaning of CPSIA §101(b)(3).
  • Component-within-component example (Attachment 1, §D.5, p. 15; Attachment 3, p. 3–4): the Commission interprets “a lead-containing component part” to mean that the material used to construct the part includes lead in its formulation, not that the part contains smaller parts that contain lead. Worked example: a sealed plastic ball compliant with the CPSIA lead limits that contains internal metal beads with lead is itself not a lead-containing component part; the metal beads are. If the ball does not provide access to the beads (through a hole, crevice, or after use-and-abuse testing), the beads are deemed inaccessible.
  • Public-comment count and commenter categories (Attachment 3 and Appendix A, p. 48–52): nine substantive public comments were received on the proposed rule. Commenter categories, summarised without naming individual firms (per the Part 12 brand-firewall strict reading): one international sleep-products trade association; one toy-testing services firm; one consumer-groups coalition (seven consumer and public-interest organisations submitting jointly); one electronic-products-association coalition (three industry associations submitting jointly); one consumer-product manufacturers coalition (represented by counsel); one apparel-and-footwear trade-association coalition (one association plus a coalition of thirty trade associations); one motorized-recreational-vehicle-firms coalition (seven motorised-recreational-vehicle manufacturers represented by counsel); one footwear-distributors-and-retailers trade association; and one individual commenter whose submission did not address the proposed accessibility rule.
  • All-terrain-vehicle exposure finding (Attachment 1, §D.5, p. 14): in the context of an exclusion request for motorised recreational vehicles, the Commission found that “the normal and reasonably foreseeable contact with lead-containing parts by children using motorized recreational vehicles would not be extensive but would occur,” citing the brake and clutch levers and the throttle controls as components users (6–12 year olds) are required to touch in regular use of the product. “It is reasonable to assume that children will not be washing their hands immediately after touching these parts.” Cross-reference: CPSC “Human Factors Response to Request for Motorized Recreational Vehicles Group Request for Exclusion from Lead Limits under Section 101(b)(1) of the Consumer Product Safety Improvement Act,” April 2009.

Methods (brief)

A CPSC Office of the Secretary ballot package dated July 23, 2009 transmitting to the Commission, for a ballot vote due July 30, 2009, three documents pertaining to the final interpretative rule on CPSIA Section 101(b)(2) inaccessibility of lead-containing component parts of children’s products: (i) the draft Federal Register notice promulgating the rule and codifying it at 16 CFR 1500.87 (Attachment 1, thirty pages including the rule preamble — Background, Statutory Authority, Notice of Proposed Rulemaking, Discussion of Comments and Responses 1 through 11, Effective Date, List of Subjects, and Conclusion — and the regulatory text of §1500.87(a) through (j) added to 16 CFR Part 1500 under authority 15 U.S.C. 1261–1278, 122 Stat. 3016); (ii) Attachment 2, a five-page staff memorandum by Robert J. Howell (Assistant Executive Director, Office of Hazard Identification and Reduction) and Kristina M. Hatlelid (Toxicologist, Directorate for Health Sciences) summarising the proposed accessibility-assessment framework (use of the §1500.48–1500.49 accessibility probes and the §1500.50–1500.53 use-and-abuse tests, excluding the §1500.51(c)/1500.52(c)/1500.53(c) bite tests), the key issues raised in public comment, and the staff’s conclusions and recommendation that the Commission issue the final rule with revisions to specify the criteria for the inaccessibility exclusion and to correct the inadvertent omission of the §1500.53 bite-test exclusion; and (iii) Attachment 3, a ten-page staff memorandum by Kristina M. Hatlelid (through Lori E. Saltzman to Mary Ann Danello) responding to the nine public comments received on the January 15, 2009 notice of proposed rulemaking (74 FR 2439), organised under six comment headings (accessibility does not mean only physical contact; testing and certification requirements; use of accessibility probes; use of use-and-abuse tests; explanation of the bite-test exclusion; fabric coverings as a barrier; aging and wear and tear; compact disks and DVDs), each followed by the CPSC staff response that became the basis for the relevant section of the Discussion of Comments in the Federal Register preamble; with Appendix A reproducing the February 24, 2009 Office of the Secretary memorandum from Todd A. Stevenson listing the nine commenters by comment number, date received, signatory, and affiliation. No primary contamination measurements, analytical chemistry, or statistical analysis are reported; the document’s contribution is the integrated primary-regulatory-record account of how the Commission resolved the eleven substantive interpretive questions that determined the operational meaning of the CPSIA Section 101(b)(2) inaccessibility exclusion — particularly the rejection of leaching-based and mouthing/swallowing-restricted readings of accessibility in favour of a physical-contact reading based on the accessibility probes and use-and-abuse tests already in force for sharp-point and sharp-edge evaluation.

Implications

  • Certification (HMTc): This source establishes the operational framework that determines which component parts of a US children’s product are exempt from the CPSIA Section 101 lead-content limits as “inaccessible.” For any HMTc category covering children’s articles subject to CPSIA Section 101, the certification scope-of-test rules must align with this framework: (i) the 16 CFR 1500.48–1500.49 accessibility probes are the binding test for whether a part is accessible, applied both before and after the §1500.50–1500.53 use-and-abuse tests appropriate to the child-age band the product is intended for; (ii) the bite tests are not used to evaluate accessibility; (iii) paint, coatings, and electroplating are never a barrier rendering substrate lead inaccessible (Section 101(b)(3), reaffirmed in §1500.87(b)); (iv) fabric coverings may render an underlying lead-containing part inaccessible provided the covering passes the appropriate use-and-abuse tests and the fabric-covered part exceeds the 5-cm one-dimension threshold imported from CPSIA Section 108; (v) acrylic polymer layers of compact disks and DVDs are not “coatings” within the meaning of Section 101(b)(3); and (vi) intentional disassembly by children older than age 8 using tools is not considered. HMTc thresholds for any children’s-product category should label deviations from these CPSIA Section 101 floors with the Part 19 rationale tags (regulatory-alignment when matching, precautionary when tighter, market-ratcheting or feasibility-driven where applicable). The rule’s age-banding logic (≤18 mo / 18–36 mo / 36–96 mo / 96 mo–12 yr) is also directly relevant to HMTc scope decisions for any certification covering products marketed across multiple child-age bands, because the use-and-abuse-test regime that applies is determined by the band the product is intended for, not by the broader CPSIA 12-and-under scope.
  • Courses: Useful as the primary-source explainer of the CPSIA Section 101 inaccessibility exclusion for students who need the agency’s own reasoning on the eleven interpretive questions that determined the rule’s operational meaning. The Discussion of Comments and Responses section (Attachment 1, §D.1 through §D.11) is the canonical citation for the Commission’s adoption of a physical-contact reading of accessibility over the leaching-based and mouthing/swallowing-restricted readings advanced by various commenters. The staff memorandum response to public comments (Attachment 3) provides the staff-level reasoning that underlies the Federal Register preamble’s terser narrative.
  • App: Not directly relevant to ingredient contamination_profile data. The CPSIA Section 101 scope (“a consumer product designed or intended primarily for children 12 years of age or younger”) and the §1500.87 inaccessibility framework would gate any future app surface that conditions risk advisories on whether a given children’s-product SKU is covered by CPSIA Section 101 and on whether the lead-containing components of that SKU are physically accessible to a child within the meaning of the rule.

Update history

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