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 cpsc2009-cpsia-101b-inaccessibility-rule.)
• §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 $60/hour\ast \ast ,foranaveragecostof\ast \ast$2,400 per submission. Annual burden for the information collection estimated to reach $600,000\ast \ast .Federal-governmentburdenpersubmissionestimatedat\ast \ast 24hours\ast \ast at\ast \ast$56/hour (GS-14 equivalent) = $1,344\ast \ast persubmission;at250submissionsperyear,federalburdenapproximately\ast \ast$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 cpsc2009-cpsia-101b-inaccessibility-rule) and the Section 101(b)(3) functional-purpose exception (see cpsc2012-cpsia-101b-functional-purpose-exception). 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.).

Wiki pages this source may touch

• lead
• toys-painted
• toys-substrate-materials
• children-personal-care
• childrens-jewelry

Verification notes

• Document identity and date. The PDF is a six-page extract of the Federal Register Vol. 74, No. 10, Thursday, January 15, 2009, pages 2428-2433, reproducing two CPSC notices of proposed rulemaking under CPSIA Section 101. The first notice (FR Doc. E9-715, signed by Secretary Todd A. Stevenson on January 9, 2009) is the proposed §§1500.89 and 1500.90 procedures rule. The second notice (FR Doc. number not visible within the PDF extract; the natural-materials NPR continues beyond p. 2433) is the Commission’s own-initiative NPR on preliminary natural-materials determinations. The first NPR was finalized at 74 FR 10475 (March 11, 2009) and the second NPR was finalized at 74 FR 43031 (August 26, 2009) at 16 CFR 1500.91. Both Federal Register cites are independently confirmed against the related corpus item hatlelid2009-cpsc-cpsia-lead-childrens-products (which lists 74 FR 10475 for the §1500.89/§1500.90 procedures rule on slides 5 and 8 and 74 FR 43031 for the §1500.91 determinations rule on slide 8) and against the related corpus item cpsc2009-cpsia-101b-inaccessibility-rule (which cross-references both companion FR notices in its preamble at the page citations recorded in that source’s Key numbers section).
• Cite-key rationale. cpsc2009-cpsia-101-procedures-npr follows the corpus pattern established by cpsc2009-cpsia-101b-inaccessibility-rule and cpsc2012-cpsia-101b-functional-purpose-exception (CPSC, CPSIA Section 101 topic, year, brief slug). The “procedures-npr” suffix reflects the document’s status as the January 2009 NPR for the procedural rules at §1500.89 and §1500.90 (and the companion natural-materials NPR at proposed §1500.91); it is distinguished from the August 2009 cpsc2009-cpsia-101b-inaccessibility-rule (which is the §1500.87 substantive inaccessibility rule). The institutional author is the U.S. Consumer Product Safety Commission (the notices are signed out by the Secretary on behalf of the Commission).
• Filename and provenance. The PDF was received via the Kimi May 21 corruption-issue re-extraction batch and lives at raw/Manual Fetch Kimi /May 21 Kimi_Agent_Download Corruption Issue/_extracted_infantcontact_05_Regulatory/05_Regulatory_CPSIA_CPSC_FDA/23_blk_pdf_leadprocedures_2009.pdf. The filename suffix “leadprocedures_2009” reflects the document’s status as the 2009 lead-content determinations/exclusions procedures NPR; raw_handle: MFK_23-blk-pdf-leadprocedures-2009 preserves the Kimi handle. SHA-256: e4dc031c6fbdbef62bb19362784ec4573a66e33a4678d64934550668a0153cad.
• Source-tier rationale. evidence_tier: A: per Part 13, the A tier covers “agency regulations, agency reports, agency guidance documents.” This is a primary-record Federal Register notice of proposed rulemaking by the U.S. Consumer Product Safety Commission under CPSIA Section 101 statutory authority. Treated as A-tier as a primary-regulatory-record document.
• source_type: gov-guidance. Filed under gov-guidance rather than gov-regulation to match the corpus pattern established for cpsc2009-cpsia-101b-inaccessibility-rule, cpsc2012-cpsia-101b-functional-purpose-exception, and hatlelid2009-cpsc-cpsia-lead-childrens-products, and to keep the routing layer fanning the source out to the relevant product pages; the routing-audit script treats source_type: gov-regulation as out-of-scope for product-page routing on the (correct) assumption that such sources will route through wiki/regulations/ instead. When a CPSIA-Section-101-specific regulation page is created in wiki/regulations/ (proposed in the Related corpus pages note below), this source can be re-typed to gov-regulation and its routing handled through that page.
• Partial-coverage note. The six-page PDF extract terminates within the natural-materials list of the second NPR (after item 4. Wood). The full natural-materials list and the companion preliminary metals list continue beyond p. 2433 in the Federal Register notice but are not captured in this PDF. The finalized natural-materials and metals lists are codified at 16 CFR 1500.91 per the August 26, 2009 final rule at 74 FR 43031 (cited in hatlelid2009-cpsc-cpsia-lead-childrens-products slide 8 and in cpsc2009-cpsia-101b-inaccessibility-rule preamble). The Key numbers section enumerates the first four natural-materials items visible in the PDF and explicitly flags the partial-coverage status to avoid implying that the four-item list above is the complete §1500.91 categorical-exemption list.
• No primary measurements. sample_n: null, matrices: [], ingredients: [] are correct — the source reports no measurements of contamination in any product matrix. It enumerates a procedural framework for Commission Section 101 determinations and exclusions, plus a preliminary categorical exemption of natural materials based on the Commission staff’s review (no measurement data tables are reproduced in the published notice).
• products: field. Four product slugs are populated: toys-painted (CPSIA Section 101 explicitly addresses lead in paint and coatings on children’s products and prohibits treating paint as an accessibility barrier); toys-substrate-materials (the Section 101(a) phased content limits apply directly to toy substrate materials, and the procedural rules govern how relief from those limits is requested); children-personal-care (the umbrella slug for the broader “children’s products designed for children 12 and under” scope to which the rule applies); and childrens-jewelry (children’s jewelry is one of the children’s-product categories CPSIA Section 101 explicitly regulates as substrate material under the 100 ppm content limit, and the semiprecious-gemstone lead-associated-mineral exclusion list in the natural-materials NPR is directly relevant to children’s-jewelry component classification). CPSIA Section 101’s statutory scope is broader than these four slugs (it covers all “children’s products” including bicycles, durable infant products, mattresses, footwear, and apparel); the routing here reflects the current-taxonomy slugs most directly addressed by the rule’s text. The product-slug routing parallels that of cpsc2009-cpsia-101b-inaccessibility-rule except that the present source does not engage the toys-battery-electronic carve-out (which is the subject of the separate §1500.88 electronic-devices interim final rule cited at p. 2433 of the inaccessibility-rule preamble, not the present NPR).
• matrices: [] is correct: this is a procedural-rule NPR, not a measurement study; there is no analytical matrix in which lead was measured.
• ingredients: [] is correct: ingredients are not the relevant taxonomy axis for a children’s-products lead-content procedural rule. CPSIA Section 101 regulates lead in the product substrate and in surface coatings, not in food ingredients.
• jurisdictions: [US] is correct: CPSIA (Public Law 110-314), 16 CFR Part 1500, and Federal Register notices are US federal law and rulemaking.
• Brand-firewall (Part 12, strict reading locked 2026-05-17). The source names no brands attached to contamination measurements. The source identifies CPSC staff personnel (Kristina M. Hatlelid, Ph.D., M.P.H., as contact point for both notices; Secretary Todd A. Stevenson as signatory of the first notice; Edith V. Parish as signatory of an unrelated FAA notice on the same Federal Register page that is not included in the corpus) and names two Supreme Court cases (Mathews v. Eldridge, 424 U.S. 319 (1976) and United States v. Florida East Coast Railway Co., 410 U.S. 224 (1973)) cited as APA-due-process precedents in footnote 1. None of these are brand attributions and none implicate Part 12. The semiprecious-gemstone lead-associated-mineral exclusion list (aragonite, bayldonite, boleite, cerussite, crocoite, linarite, mimetite, phosgenite, vanadinite, wulfenite) is a mineralogical-name list, not a brand list.
• Wiki/HMTc firewall (Part 2). The source proposes no HMTc thresholds and is not compared to existing HMTc certification levels in the body. The Implications section flags that the §1500.89/§1500.90 procedural framework and the §1500.91 natural-materials categorical exemption determine which Section 101 testing requirements apply to which children’s-product components and notes that HMTc deviations from the Section 101 floors should be labeled with the Part 19 rationale tags. This is a procedural pointer to the threshold-setting workflow, not an HMTc threshold proposal.
• Speciation flag. Not applicable; lead is reported as content (ppm by weight in product substrate) without speciation. CPSIA Section 101 is concerned with total lead content in the product substrate and in surface coatings, not with lead speciation.
• Funding and conflicts. Not applicable: government rule promulgation; no funding disclosure or conflict-of-interest statement applies to a Commission-authored notice of proposed rulemaking.
• License. public-reference-only: Federal Register notices and CPSC rule packages are US government work in the public domain (17 USC 105), so re-hosting and quotation are unrestricted under US law; the conservative public-reference-only label is used to match the corpus pattern for primary regulatory documents (cf. cpsc2009-cpsia-101b-inaccessibility-rule, cpsc2012-cpsia-101b-functional-purpose-exception, hatlelid2009-cpsc-cpsia-lead-childrens-products).
• Related corpus pages. cpsc2009-cpsia-101b-inaccessibility-rule is the July 2009 ballot package and August 2009 final rule on the substantive Section 101(b)(2) inaccessibility exclusion at 16 CFR 1500.87; the present source is the procedural companion (governing how Section 101 determinations and exclusions are requested) issued earlier in the same 2009 rulemaking cycle. cpsc2012-cpsia-101b-functional-purpose-exception is the same series of Section 101(b) interpretive rules approached three years later under the same statutory authority. hatlelid2009-cpsc-cpsia-lead-childrens-products is the December 2009 staff-presentation summary of the broader CPSIA Section 101 regime that references both the §1500.89/§1500.90 procedures rule (slide 5: 74 FR 10475 final, March 11, 2009; codified at 16 CFR 1500.90) and the §1500.91 determinations rule (slide 8: 74 FR 43031 final, August 26, 2009; codified at 16 CFR 1500.91) — both finalizations of the NPRs reproduced in the present source. cfa2012-cpsia-lead-fact-sheet is a 2012 consumer-advocacy summary of the same CPSIA Section 101 regime. No CPSIA-Section-101-specific regulation page yet exists in wiki/regulations/; the natural next-step regulation page would be the routing target for the present source plus the four other sources above. Per Part 10 and the manual-fetch skill, that regulation page is a Karen-curated new-page proposal rather than something created during this ingest.

Page history

The five most recent substantive edits to this page. The full version history lives in git; when DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.