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Children's Products Containing Lead; Notice of Proposed Procedures and Requirements for a Commission Determination or Exclusion (16 CFR 1500.89 and 1500.90); and companion Notice of Proposed Rulemaking on Proposed Determinations Regarding Lead Content Limits on Certain Materials or Products

CPSC (2009) — CPSIA Section 101 Determinations/Exclusions Procedures NPR (16 CFR 1500.89 and 1500.90) and Companion Natural-Materials NPR A six-page extract of the Federal Register issue of Thursday, January 15, 2009 (Vol.

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CPSC (2009) — CPSIA Section 101 Determinations/Exclusions Procedures NPR (16 CFR 1500.89 and 1500.90) and Companion Natural-Materials NPR

A six-page extract of the Federal Register issue of Thursday, January 15, 2009 (Vol. 74, No. 10, pp. 2428-2433) reproducing two companion Consumer Product Safety Commission notices of proposed rulemaking issued under the Consumer Product Safety Improvement Act of 2008 (CPSIA, Public Law 110-314, 122 Stat. 3016) Section 101. The first notice (FR Doc. E9-715, signed January 9, 2009 by Secretary Todd A. Stevenson) proposes 16 CFR 1500.89 (procedures and requirements for a Commission determination under CPSIA Section 101(a) that a commodity or class of materials or a specific material or product does not exceed the Section 101(a) lead-content limits) and 16 CFR 1500.90 (procedures and requirements for a Commission exclusion under CPSIA Section 101(b)(1) of a specific product or material that exceeds the lead-content limits but will not result in absorption of any lead into the human body nor have any other adverse impact on public health or safety). The second notice (commencing on p. 2433) is the Commission’s notice of proposed rulemaking on preliminary determinations that certain natural, untreated and unadulterated materials and metals do not exceed the Section 101(a) lead-content limits; only the first four items of the natural-materials list (precious gemstones; certain semiprecious gemstones; natural or cultured pearls; wood) are visible within the six-page PDF extract — the natural-materials list and the accompanying preliminary metals list continue beyond p. 2433. The contact point for both notices is Kristina M. Hatlelid, Ph.D., M.P.H., Directorate for Health Sciences. Public-comment deadlines: February 17, 2009. The first NPR was finalized at 74 FR 10475 (March 11, 2009); the second NPR was finalized at 74 FR 43031 (August 26, 2009) at 16 CFR 1500.91. The PDF contains no primary contamination measurements; it is included in the Heavy Metal Index corpus as the primary-regulatory-record source for the procedural rules that govern how CPSIA Section 101 determinations and exclusions are requested and adjudicated, and as the primary-record citation for the Commission’s preliminary determinations that certain natural materials are categorically exempt from the Section 101 testing requirements.

Key numbers

  • CPSIA statutory citation and Section 101(a) phased lead-content limits (p. 2429, §A): the Consumer Product Safety Improvement Act of 2008 is Public Law 110-314. Section 101(a) provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead; after August 14, 2009, the limit drops to 300 ppm; on August 14, 2011, the limit may be further reduced to 100 ppm “unless the Commission determines that it is not technologically feasible to have this lower limit.”
  • Paint/coatings/electroplating barrier prohibition (p. 2429, §A): “Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inaccessible to a child.” (This statutory prohibition is later operationalized in the 16 CFR 1500.87 inaccessibility rule, see 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.)
  • §1500.89 — procedures for Section 101(a) determinations (pp. 2431-2432, §C.1 and proposed §1500.89): the Commission may make a determination, on its own initiative or upon request, that a commodity or class of materials or a specific product does not contain lead levels exceeding 600 ppm, 300 ppm, or 100 ppm. Requests must (1) be e-mailed to cpsc-os@cpsc.gov titled “Section 101 Request for Lead Content Determination” or mailed to the Office of the Secretary; (2) be written in English; (3) identify the requestor; and (4) provide documentation including (i) detailed product/material description, (ii) lead-content data for product parts, (iii) information on manufacturing processes through which lead may be introduced, (iv) any other relevant information on lead-content potential, (v) detailed information on test methods, equipment, and representativeness, and (vi) an assessment of manufacturing processes supporting the conclusion that they would not be a source of lead contamination. MSDS sheets are not sufficient to satisfy the representative-testing criterion. Industry-wide applications for commodity-like materials are prioritized over single-manufacturer brand-specific products.
  • §1500.90 — procedures for Section 101(b) exclusions (pp. 2432-2433, §C.2 and proposed §1500.90): the Commission may exclude a specific product or material from the Section 101(a) lead-content limits if it determines, after notice and a hearing, on the basis of the best-available, objective, peer-reviewed, scientific evidence that lead in such product or material will neither (1) result in the absorption of any lead into the human body, taking into account normal and reasonably foreseeable use and abuse by a child, including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product, nor (2) have any other adverse impact on public health or safety. Requests must satisfy the same six documentation requirements as §1500.89 plus (5) provide best-available, objective, peer-reviewed, scientific evidence on how much lead is present, how much lead comes out, the conditions under which release occurs, and information relating to a child’s interaction with the product; and (6) provide unfavorable best-available scientific evidence that is reasonably available to the requestor.
  • Hearing-procedure form (p. 2430, §B.2 and footnote 1): the Commission determines that “an oral hearing is not necessary to satisfy the requirements of due process.” APA Section 553 notice-and-comment procedures based on written submissions are deemed adequate. Authority cited: Mathews v. Eldridge, 424 U.S. 319, 334-35 (1976); United States v. Florida East Coast Railway Co., 410 U.S. 224, 238-41 (1973). Section 101(b) does not require a “hearing on the record.”
  • Section 101(b)(1) difficulty caveat (p. 2430, footnote 2): “The Commission notes that the statutory language of section 101(b)(1) makes it difficult to make a showing that would be adequate to exclude any material or product on that basis.” (Foreshadowing the operational result that the Section 101(b)(1) “no absorption” pathway is rarely successful in practice; later Section 101(b)(2) inaccessibility-based and Section 101(b)(3) functional-purpose-based exclusions become the dominant Section 101(b) pathways.)
  • Effect of filing on enforcement (p. 2431, §D, and proposed §1500.89(f) and §1500.90(f)): filing a request for a Section 101 determination or exclusion does not automatically stay any provision or limit; CPSIA Section 101 requirements remain in full force and effect, and the Commission’s enforcement discretion is not eliminated or diminished. Cross-reference: CPSIA §101(e).
  • Paperwork Reduction Act estimates (p. 2431, §H): staff estimates a minimum of approximately 250 firms may submit requests. Burden to assemble information and prepare a submission, if performed by a senior management employee, may take approximately 40 hours at approximately 2,400 per submission. Annual burden for the information collection estimated to reach 56/hour (GS-14 equivalent) = 336,000.
  • Effective-date proposal (p. 2431, §I): the proposed effective date is the date of publication of a final rule in the Federal Register, “for good cause shown,” dispensing with the APA’s general 30-day-publication-before-effective-date requirement under 5 U.S.C. 553(d)(3).
  • Companion natural-materials NPR — statutory framing (p. 2432, §B and p. 2433, §B): the Commission staff identified commodities or classes of materials that “do not inherently contain lead or contain lead that does not exceed the CPSIA lead limits of 600 ppm or 300 ppm.” Preliminary determinations are “based on materials that are untreated and unadulterated with respect to the addition of materials or chemicals, including pigments, dyes, coatings, finishes or any other substance, and that do not undergo any processing that could result in the addition of lead into the product or material.”
  • Companion natural-materials NPR — preliminary determinations (partial list, items 1-4 only as visible within this PDF extract) (p. 2433):
    1. Precious gemstones: diamond, ruby, sapphire, emerald.
    2. Certain semiprecious gemstones provided that the mineral or material is not based on lead or lead compounds and is not associated in nature with any mineral that is based on lead or lead compounds. The notice enumerates an explicit non-exhaustive lead-associated mineral exclusion list: aragonite, bayldonite, boleite, cerussite, crocoite, linarite, mimetite, phosgenite, vanadinite, and wulfenite.
    3. Natural or cultured pearls.
    4. Wood. (The full natural-materials list continues beyond p. 2433 in the Federal Register notice but is not captured in the six-page PDF extract; the finalized list is codified at 16 CFR 1500.91 per the August 26, 2009 final rule at 74 FR 43031.)
  • Companion natural-materials NPR — public-comment process (p. 2433): Written comments must be received by February 17, 2009, e-mailed to Sec101Determinations@cpsc.gov captioned “Section 101 Determinations of Certain Materials or Products NPR” or mailed to the Office of the Secretary; facsimile filings to (301) 504-0127 also accepted. Identical comment-process structure to the procedures NPR.
  • List of Subjects in 16 CFR Part 1500 (p. 2431, §K, and p. 2432): “Consumer protection, Hazardous materials, Hazardous substances, Imports, Infants and children, Labeling, Law enforcement, and Toys.”
  • Statutory authority (p. 2432, proposed amendment to 16 CFR Part 1500): “15 U.S.C. 1261-1278, 122 Stat. 3016.” The 122 Stat. 3016 citation is Public Law 110-314 (CPSIA, 2008).

Methods (brief)

Two companion CPSC notices of proposed rulemaking published on consecutive pages of the Federal Register of January 15, 2009 (74 FR 2428-2433+), each opened to public written comment under APA Section 553 procedures with a comment deadline of February 17, 2009. The first notice (FR Doc. E9-715, signed January 9, 2009 by Secretary Todd A. Stevenson) proposes amendments to 16 CFR Part 1500 to add new §1500.89 and §1500.90 establishing procedures and documentation requirements for two distinct CPSIA Section 101 pathways: §1500.89 governs Commission determinations under Section 101(a) that a commodity or class of materials or a specific product does not exceed the phased Section 101(a) lead-content limits (600 ppm by 2009-02-10, 300 ppm by 2009-08-14, possibly 100 ppm by 2011-08-14), and §1500.90 governs Commission exclusions under Section 101(b)(1) of products that exceed the limits but will not result in lead absorption or other adverse health effects. Each procedural rule enumerates the request-submission channel (e-mail to cpsc-os@cpsc.gov, mail to Office of the Secretary, or facsimile), the language requirement (English), the requestor-identification requirements, and the documentation requirements: detailed product/material description, lead-content data for parts, manufacturing-process information, other relevant lead-content information, detailed test-method information (equipment, techniques, representativeness statement), and an assessment of manufacturing processes. The §1500.90 exclusion pathway additionally requires the best-available, objective, peer-reviewed, scientific evidence on lead presence, release, and child-interaction conditions, plus unfavorable scientific evidence reasonably available to the requestor. Initial review of complete requests is assigned to the Office of Hazard Identification and Reduction, whose preliminary recommendation triggers (where favorable) a notice of proposed rulemaking inviting public comment before final Commission action. The Commission determines that paper hearings under APA §553 satisfy due process for these decisions (citing Mathews v. Eldridge and United States v. Florida East Coast Railway) and that no oral hearing is required. The second notice (commencing on p. 2433, FR Doc. number not visible within the PDF extract) is the Commission’s own-initiative NPR on preliminary determinations that certain natural materials — restricted to untreated, unadulterated, and unprocessed (no addition of pigments, dyes, coatings, finishes, or any substance, and no processing that could add lead) — do not exceed the Section 101(a) lead-content limits. Only the first four items of the natural-materials list are visible within the six-page PDF extract (precious gemstones; certain semiprecious gemstones with an explicit lead-associated-mineral exclusion list; natural or cultured pearls; wood); the full list is finalized at 16 CFR 1500.91 per the August 26, 2009 final rule (74 FR 43031). No primary contamination measurements, analytical chemistry, or statistical analysis are reported; the document’s contribution is the primary-regulatory-record account of the Commission’s procedural framework for CPSIA Section 101 determinations and exclusions and the Commission’s own-initiative identification of categorically-exempt natural materials.

Implications

  • Certification (HMTc): This source establishes the procedural and documentation framework by which a manufacturer, importer, or interested party may obtain Commission relief from the CPSIA Section 101 testing requirements for a specific material or product. For any HMTc category covering children’s articles subject to CPSIA Section 101, the certification scope-of-test rules should reflect that natural, untreated, and unadulterated materials within the §1500.91 determinations list (preliminarily identified in this NPR for diamond, ruby, sapphire, emerald, certain non-lead-associated semiprecious gemstones, natural or cultured pearls, wood, and the additional items finalized at 74 FR 43031) are categorically exempt from the Section 102 third-party testing requirement, while any other material requires either the §1500.89 determination pathway (data demonstrating inherent absence of lead above the limit) or the §1500.90 exclusion pathway (peer-reviewed scientific evidence that lead in the product will not be absorbed or have other adverse impact). The Commission’s footnote that “the statutory language of section 101(b)(1) makes it difficult to make a showing that would be adequate to exclude any material or product on that basis” foreshadows the operational result that the §1500.90 pathway is rarely successful and that most Section 101(b) relief in practice flows through the later Section 101(b)(2) inaccessibility rule at 16 CFR 1500.87 (see 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) and the Section 101(b)(3) functional-purpose exception (see Staff Report — CPSIA Section 101(b): Functional Purpose Exception from Lead Content Limit for Children's Products for a Specific Product, Class of Product, Material, or Component Part). HMTc thresholds for any children’s-product category should label deviations from the Section 101 floors with the Part 19 rationale tags (regulatory-alignment when matching, precautionary when tighter). The semiprecious-gemstone lead-associated-mineral exclusion list (aragonite, bayldonite, boleite, cerussite, crocoite, linarite, mimetite, phosgenite, vanadinite, wulfenite) is the primary-record reference for any future HMTc category covering children’s jewelry incorporating mineral components.
  • Courses: Useful as the primary-source explainer of the CPSIA Section 101 determinations/exclusions procedural regime for students who need the citation-level map of how a Commission-relief request is structured, documented, and adjudicated. The §1500.89 vs §1500.90 distinction (Section 101(a) “does not exceed the limit” pathway vs Section 101(b)(1) “exceeds the limit but no absorption / no adverse impact” pathway) is the foundational procedural taxonomy for understanding how the four 2009-2012 Section 101 implementing rules (§1500.87 inaccessibility, §1500.88 electronic-devices interim final, §1500.89 procedures, §1500.90 exclusion procedures, §1500.91 determinations) relate to each other. The Mathews v. Eldridge and Florida East Coast Railway citations are useful as the procedural-due-process basis for paper-hearing adequacy under APA §553.
  • 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”) is the relevant gating condition for any future app surface that conditions risk advisories on whether a given children’s-product SKU is covered by CPSIA Section 101. The §1500.91 natural-materials exemption could become an app-surface filter for SKUs whose covered components are entirely within the categorical-exemption list (natural wood, unadulterated pearls, etc.).

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