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miles southwest of the LOM/NDB. This Class section 14(a) of the Consumer Product issued a notice of proposed rulemaking E airspace area is effective during the specific Safety Act (CPSA), as amended by on preliminary determinations that dates and times established in advance by a section 102(a) of the CPSIA.1 By this certain natural materials do not exceed Notice to Airmen. The effective date and time rule, the products and materials the lead content limits under section will thereafter be continuously published in the Airport/Facility Directory. determined by the Commission to fall 101(a) of the CPSIA. The preliminary under the lead content limits, are no determinations were based on materials * * * * * longer subject to section 101(a) of the that are untreated and unadulterated Issued in Seattle, Washington, on August CPSIA and no testing of these products with respect to the addition of materials 14, 2009. and materials is required under section or chemicals, including pigments, dyes, H. Steve Karnes, 102(a) of the CPSIA. coatings, finishes or any other Team Manager, Operations Support Group, B. Statutory Authority substance, and that did not undergo any Western Service Center. processing that could result in the [FR Doc. E9–20282 Filed 8–25–09; 8:45 am] Section 3 of the CPSIA grants the addition of lead into the product or BILLING CODE 4910–13–P Commission general rulemaking material. These materials included: authority to issue regulations, as • Precious gemstones (diamond, ruby, necessary, to implement the CPSIA. The sapphire, emerald); CONSUMER PRODUCT SAFETY Commission has the authority under • Certain semiprecious gemstones COMMISSION section 3 of the CPSIA to make provided that the mineral or material is determinations that certain commodities not based on lead or lead compounds 16 CFR Part 1500 or classes of materials or products do and is not associated in nature with any not, and, by their nature, will not mineral that is based on lead or lead Children’s Products Containing Lead; exceed the lead limits prescribed in compounds (minerals that contain lead Determinations Regarding Lead section 101(a) of the CPSIA. or are associated in nature with Content Limits on Certain Materials or Accordingly, in this rule, the minerals that contain lead include, but Products; Final Rule Commission has determined that certain are not limited to, the following: products or materials inherently do not Aragonite, bayldonite, boleite, cerussite, AGENCY: Consumer Product Safety contain lead or contain lead at levels Commission. crocoite, linarite, mimetite, phosgenite, that do not exceed the lead content vanadinite, and wulfenite); ACTION: Final rule. limits under section 101(a) of the • Natural or cultured pearls; CPSIA. The effect of such a Commission • SUMMARY: The Consumer Product Safety Wood; determination would be to relieve the • Commission (Commission) is issuing a Natural fibers (such as cotton, silk, material or product from the testing final rule on determinations that certain wool, hemp, flax, linen); and requirement of section 102 of the CPSIA • materials do not exceed the lead content Other natural materials including for purposes of supporting the required limits specified under section 101(a) of coral, amber, feathers, fur, untreated certification. However, if the material or the Consumer Product Safety leather. product changes such that it exceeds the Improvement Act of 2008 (CPSIA). See 74 FR at 2435. lead limits of section 101(a) of the DATE: Effective Date: This regulation CPSIA, then the determination is not In addition, in the proposed rule, the becomes effective on August 26, 2009. applicable to that material or product. Commission preliminarily determined FOR FURTHER INFORMATION CONTACT: The changed or altered material or that certain metals and alloys did not Kristina Hatlelid, Ph.D., M.P.H., product must then meet the statutory exceed the lead content limits under Directorate for Health Sciences, lead level requirements. The section 101(a) of the CPSIA provided Consumer Product Safety Commission, Commission intends to obtain and test that no lead or lead-containing metal is 4330 East-West Highway, Bethesda, products in the marketplace to assure intentionally added. The metals and Maryland 20814; telephone (301) 504– that products comply with the CPSIA alloys considered included surgical 7254, e-mail [email protected]. lead limits and will take appropriate steel, precious metals such as gold (at SUPPLEMENTARY INFORMATION: enforcement action if it finds a product least 10 karat); sterling silver (at least to have lead levels exceeding those 925/1000); platinum; palladium; A. Background allowed by law. rhodium; osmium; iridium; ruthenium. Under section 101(a) of CPSIA, (See 74 FR at 2435). The preliminary C. Notice of Proposed Rulemaking consumer products designed or determinations did not extend to the intended primarily for children 12 years In the Federal Register of January 15, non-steel or non-precious metal old and younger that contain more than 2009 (74 FR 2433), the Commission components of a product, such as solder 600 ppm of lead (as of February 10, or base metals in electroplate, clad, or 2009); 300 ppm of lead (as of August 14, 1 Currently, there is a stay of enforcement of fill applications. 2009); and 100 ppm after three years (as testing and certification requirements of certain provisions of subsection 14(a) of the CPSA, as D. Discussion of Comments to the of August 14, 2011), unless the amended by section 102(a) of the CPSIA until Commission determines that it is not February 10, 2010 (see 74 FR 6936 (February 9, Proposed Rule technologically feasible to have this 2009)). The stay does not cover those requirements The proposed rule generated several where testing and certification was required by lower limit, are considered to be banned subsection 14(a) of the CPSA before the CPSIA’s hundred comments from a diverse range hazardous substances under the Federal enactment, and third party testing and certification of interests, including advocacy groups, Hazardous Substances Act (FHSA). requirements for lead paint, full-size and non-full consumer groups, a State’s attorney Products below these lead content limits size cribs and pacifiers, small parts, metal general’s office, and small businesses components of children’s metal jewelry, are not banned; however, in the absence certifications expressly required by CPSC including crafters. No comment of Commission action, these products regulations, certifications required under the opposed the proposed determinations, and materials used to make children’s Virginia Graeme Baker Pool and Spa Safety Act, and, therefore, the final rule retains products remain subject to the lead certifications of compliance required for All-Terrain those determinations. The proposed rule Vehicles in section 42(a)(2) of the CPSA, and any limits and consequently, the testing voluntary guarantees provided for in the Flammable considered those initial determinations requirements of certain provisions of Fabrics Act. in the context of whether the lead limits

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of such materials would exceed 600 in this rule) and plastic components, the banned candles made with metal-cored ppm and 300 ppm. Commission has found that these wicks with lead content exceeding 600 After reviewing the comments and materials do sometimes contain lead. ppm. The Commission found that, as a additional data submitted, the For example, the Commission lead-cored wick candle burns, some of Commission further evaluated those previously examined metal and plastic the lead may vaporize and be released materials in the context of whether components in the context of children’s into the air. (See Metal-Cored these materials would exceed 100 ppm, jewelry. The CPSC Directorate for Candlewicks Containing Lead and and finds that, for the reasons discussed Laboratory Sciences, Division of Candles With Such Wicks, 68 FR 19142 in the preamble, that such materials Chemistry analyzed 466 children’s (April 18, 2009).) The Commission would not exceed 100 ppm. metal jewelry items from 156 stated, ‘‘[s]ome of this lead may deposit Accordingly, the final rule revises the compliance samples since 1996. Nearly onto floors, furniture and other surfaces language in former §§ 1500.91(c) and (d) 270 items tested had total lead of 600 in the room where children may be (renumbered as §§ 1500.91(d) and (e)) to ppm or more. Numerous metal exposed to it. One cannot tell by looking remove references to 600 ppm and 300 components including pendants, at the wick core if it is made of lead, and ppm, and includes a reference to ‘‘lead charms, chains, links, hooks, clasps, and there is no simple way for a consumer content limits’’ to reflect that the beads contained lead content exceeding to determine its lead content. The determinations made in the final rule 300 ppm, and some components were presence of lead in a wick can be also fall below 100 ppm for such composed of almost 100 percent lead. In determined only by laboratory materials. Most comments sought to add addition, several plastic components analysis.’’ Id. at 19143. Given the Commission’s past to the list of materials; accordingly, the such as beads and cords had lead preamble to this final rule will focus on experience with lead in plastic and contents ranging from 540 ppm to 5,020 those comments suggesting additions to metal, we cannot make a determination ppm. See CPSC Memorandum from the list and also describe the changes that these materials do not or would not David Cobb to Kristina M. Hatlelid, made to the final rule as a result of those contain lead in an amount that does not ‘‘Summary of Test Results for Lead in comments. After review of the exceed the lead content limits without Children’s Metal Jewelry,’’ November comments and data, including test a demonstration that the material or 29, 2006. Tab B of Briefing Package for results, if any, submitted, the product does not and would not contain Petition Requesting Ban of Lead in Toy Commission has determined that some lead because the inclusion of lead Jewelry (Petition No. HP 06–1), materials that fall below the lead would either interfere with or content limits may be manufactured or December 4, 2006.) The Commission compromise the manufacture of the man-made. Accordingly, we have also has found lead in other children’s material or product, or interfere with or revised proposed § 1500.91(c) items made of plastic. An analysis of 81 compromise the use of the material or (renumbered as § 1500.91(d)) to remove polyvinyl chloride (PVC) bib samples in product. Such materials or products the word ‘‘natural’’ before ‘‘materials.’’ May 2007 showed samples with total must also demonstrate that lead We note that in the final rule on lead content of up to 6,880 ppm. (See contamination cannot occur during the procedures and requirements for a CPSC Staff Analysis of Lead Content manufacturing process or be otherwise Commission determination (procedures and Accessible Lead in Vinyl Baby Bibs, adulterated. The CPSIA was enacted, in rule), the Commission explicitly stated May 5, 2007; http://www.cpsc.gov/ part, to ensure that any material used in that any request for a determination that CPSCPUB/PREREL/prhtml07/ any part of a children’s product that a specific material or product contains 07175.pdf.) In November, 1997, the could contain lead would be tested by no lead or a lead level below the CPSC staff also analyzed the lead a third-party conformity assessment applicable statutory limit must show content for numerous vinyl children’s body (laboratory) so that lead-containing that the product or material does not, products and found that several materials would not be used, either and would not, exceed the lead limit children’s products, such as an umbrella deliberately, or inadvertently, to make specified in the request. (74 FR 10475, and toy telephone, showed lead content such products. The determinations 10477 (March 11, 2009)). Accordingly, up to 6,300 ppm. (See CPSC Staff Report excluding metal, plastic, and painted the manufactured materials that the on Lead and Cadmium in Children’s components used in children’s products Commission has determined to be below Polyvinylchloride (PVC) Products, will ensure that the materials that do the lead content limits in this rule are November 21, 2007; http:// contain lead or could contain lead will limited only to those materials that we www.cpsc.gov/CPSCPUB/PUBS/ continue to be tested consistent with could verify do not, and would not pbcdtoys.html.) The Commission has section 102 of the CPSIA. contain lead because either their found lead in other products as well. Most comments requested that the composition or formulation does not For example, in May 2001, the Commission add other materials to the contain lead or the use of lead would Commission found that vinyl list of materials that the Commission interfere with or compromise the miniblinds that had lead added to determines are not expected to contain material or the product on which it is stabilize the plastic in the blinds lead above the lead limits prescribed used, and there is no possibility that the presented a lead poisoning hazard for under section 101(a) of the CPSIA. [Ref. product or material can be contaminated young children. The Commission found 2]. However, most comments were not with lead or otherwise adulterated. that over time, the plastic deteriorates supported by specific data or other Given the well documented dangers to from exposure to sunlight and heat to information relevant to the children for exposure to lead paint, the form lead dust on the surface of the determinations of lead content of the Commission will not consider any blind. In homes where young children materials, and so we did not have a determinations for paints or similar were present, children could ingest the sufficient evidentiary basis to determine surface-coating materials that are subject lead by wiping their hands on the blinds whether those materials would not be to the lead paint ban under the and then put their hands in their expected to contain lead above the Commission’s regulations at 16 CFR part mouths. (See Report on lead in vinyl statutory limits. For determinations on a 1303. miniblinds Part 1–Part 3 (May 2, 2001); specific material or product, a party For metal (except for the http://www.cpsc.gov/library/foia/foia97/ must submit an application that determinations made for certain metals os/bp971.pdf.) In 2003, the Commission provides the information requested

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under the procedures rule (see 74 FR A determination by the Commission under regarding plant and animal-based 10475), including objectively reasonable paragraph (b) of this section that a material materials must be confined to those and representative test results and other or product does not contain lead levels that materials that are unadulterated by the evidence showing that the product or exceed 600 ppm, 300 ppm, or 100 ppm, as addition of chemicals and materials applicable, does not relieve the material or (such as paints and similar surface- material does not and would not exceed product from complying with the applicable the lead content limits. The list of lead limit as provided under paragraph (a) of coating materials, as discussed further determinations made in this rule is not this section if the product or material is in part D.7 of this preamble) since such exhaustive; the Commission will changed or altered so that it exceeds the lead treatments or additions may not comply continue to evaluate other requests on content limits. with the lead limits without further testing. Although most materials materials or products submitted under In addition, the Commission has in identified in the comments were not the procedures rule, and consider place procedures and requirements for a specifically included in the proposed whether to re-evaluate a material if new Commission determination that a rule, the proposed determinations evidence indicates that a re-evaluation specific material or product contains no included three categories of natural is warranted or the Commission receives lead or a lead level below the applicable materials with examples that are similar data or information demonstrating that statutory limit (see 74 FR 10475). to many of these items (i.e., wood; a particular material does not and Among other things, any request must natural fibers, including cotton, silk, would not contain lead. In such be supported by objectively reasonable circumstances, the Commission will wool, hemp, flax, and linen; other and representative test results or other natural materials including coral, amend the rule, if appropriate. evidence showing that the product or In other cases, the comments did amber, feathers, fur, and untreated materials does not, and would not, leather). Accordingly, the final rule provide test data and other information exceed the lead limit specified in the relevant to this proceeding, and those includes other materials, such as plant request. 74 FR at 10477. and animal-based materials that have comments are addressed in parts D.1 As for compliance with the statutory through D.15 of this preamble below. not been adulterated or modified as a limits, compliance and enforcement new § 1500.91(d)(8). Specifically, the 1. Compliance With Section 101(a) of activities, including market testing, have new provision covers ‘‘other plant- the CPSIA always been and continue to be derived and animal-derived materials, essential to the Commission’s mission. Several commenters generally including, but not limited to, animal Moreover, even when a particular glue, beeswax, seeds, nut shells, supported the reduction of potentially product or material has been relieved of repetitive and wasteful testing of flowers, bone, sea shell, coral, amber, the testing and certification feathers, fur, leather.’’ Leather is products and materials that are not requirements under section 102 of the expected to contain lead, but they discussed further in part D.13(c) of this CPSIA, manufacturers and importers preamble. stressed that the Commission should remain responsible for verifying that the proceed carefully to ensure that the material or product has not been altered 3. Foodstuffs requirements of the law are met. The or modified, or experienced any change Some commenters stated that commenters asserted that the in the processing, facility or supplier foodstuffs or materials suitable in food Commission should not only request conditions that could impart lead into uses may be used in making children’s data from firms, but should test the material or product to ensure that it products and should be determined to children’s products itself, especially meets the statutory lead levels at all comply with lead limits given that they those products that have not, to date, times. are largely natural plant or animal based been subject to lead content 2. Plant and Animal Based Materials materials and are considered edible or requirements or testing for lead content. safe for use by consumers. Some One commenter also stated that the final Many commenters asserted that there materials mentioned included vegetable rule should make clear that materials are many natural, plant or animal-based and nut oils, medicinal-grade mineral that the Commission determines do not materials that likely do not contain oil, table salt, flax seed, food coloring, contain excess lead levels must still appreciable lead content and should be food preservatives, cream of tartar, grain comply with the statutory lead content suitable for use in children’s products flours, dried beans, dried corn, millet, standard. without testing for lead content. herbs, cherry pits, rice, seeds, milk, The Commission has already Materials mentioned include plants in honey, beeswax, candelilla wax, and indicated that it intends that all general, and specifically bark, leaves, carnauba wax. children’s products subject to a flowers and flower petals, seeds, cones, In general, articles that fall within the determination must still comply with loofa, rattan, wicker, bamboo, bamboo statutory definition of ‘‘food’’ under the the lead limit in its ‘‘Statement of fiber, plant-based dyes, nut shells, Federal Food, Drug, and Cosmetic Act Commission Enforcement Policy on buckwheat hulls, essential plant oils, (FFDCA) (21 U.S.C. 321 et seq.) are Section 101 Lead Limits,’’ dated lavender, witch hazel, jute, kapok, excluded from the definition of February 6, 2009 (available on the kenaf, ramie, sisal, hemp, agave, ‘‘consumer product’’ under the CPSC’s Web site at http://www.cpsc.gov/ coconut, soy, moss, straw, jojoba oil, Consumer Product Safety Act (CPSA). about/cpsia/101lead.pdf). However, the and tung oil. Animal-based materials 15 U.S.C. 2052(a)(5)(I). Section 321(f) of Commission agrees with the comments that were mentioned included yak, the FFDCA defines ‘‘food’’ as ‘‘(1) that the final rule should remind angora, mohair, llama, alpaca, bison, articles used for food or drink for man interested parties of their obligation to camel, guanaco, cashmere, horse hair, or other animals, (2) chewing gum, and comply with the lead limits even if their claws, horn, seashells, bone, animal (3) articles used for components of any products are the subject of a glue, shellac. such article.’’ Section 402(a)(1) of the determination, and so we have amended Our review showed that plant and FFDCA provides that a food is deemed the final rule to create a new animal-based materials generally do not to be adulterated if it contains any § 1500.91(c) (and renumbering the contain lead at levels that exceed the poisonous or deleterious substances, remaining paragraphs accordingly) CPSIA lead limits. [Ref. 1]. However, we such as chemical contaminants, which stating that: find that any determinations made may or ordinarily render it harmful to

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health. Under this provision and other the marketplace. However, we believe constructed of wood, adhesives, and provisions in the FFDCA, the Food and that in most instances, glues and other materials. Drug Administration (FDA) oversees the adhesives will be inaccessible to The commenters did not provide safety of much of the food supply. children. sufficient test data or other information Accordingly, the Commission will not The Commission has issued a final to enable us to assess whether the lead make determinations on lead content interpretative rule on inaccessible content of manufactured wood products limits for foods used in consumer component parts (inaccessibility rule) that contain various non-wood materials products. However, to the extent that which finds that a component part is would fall under the lead content limits there are materials available to not accessible if it is not physically prescribed by the CPSIA. A request for manufacturers, such as beeswax, that exposed by reason of a sealed covering a Commission determination for are sometimes sold as food, but that are or casing and does not become materials that fall under the lead not always sold in a form intended for physically exposed through reasonably content limits of the CPSIA must consumption, the Commission will treat foreseeable use and abuse of the product provide data and other information such products as other natural materials including swallowing, mouthing, requested under the procedures rule. if they are unadulterated and have not breaking, or other children’s activities Accordingly, although the final rule been treated with lead-containing and the aging of the product. (74 FR does not include composite wood material, and new § 1500.91(d)(8) 39535 (August 7, 2009)). In the products, a request for a specific specifically identifies some of those inaccessibility rule, the Commission materials determination may be products, such as beeswax. provided that accessibility probes submitted to the Commission, specified for sharp points or edges at 16 consistent with those requirements. 4. Cosmetics CFR 1500.48 through 1500.49 should be 7. Certain Finishes A few commenters suggested that used to determine whether a lead- determinations be made for soaps, containing component can be contacted Several commenters requested that lotions and dental floss. by a child. In addition, the water based paints, acrylic paints, water In general, articles that fall within the inaccessibility rule provides that the use based clear finishes, varnishes, lacquers, statutory definition of ‘‘cosmetic’’ or and abuse tests specified in 16 CFR and milk paint be determined to comply ‘‘device’’ under the FFDCA (21 U.S.C. 1500.50 through 1500.53 should be used with the lead content limits. 321 et seq.) are excluded from the to assess the accessibility of lead- We decline to revise the rule as definition of ‘‘consumer product.’’ 15 component parts during normal and suggested by the comments. The U.S.C. 2052(a)(5)(H). Soaps and lotions reasonably foreseeable use and abuse of Commission has long-standing are considered cosmetics under the a product by a child. However, paint, regulations on paint and similar surface FFDCA as ‘‘articles intended to be coatings or electroplating may not be coatings at 16 CFR part 1303. Section rubbed, poured, sprinkled, or sprayed considered a barrier that would render 101(f) of the CPSIA imposed an even on, introduced into, or otherwise lead in the substrate to be inaccessible stricter lead limit for paint and similar applied to the human body or any part to a child. surface coatings from 600 ppm total lead thereof for cleansing, beautifying, Most glues and adhesive are used to by weight to 90 ppm total lead by promoting attractiveness, or altering the affix decorations and ornamentation to weight as of August 14, 2009. Because appearance.’’ 21 U.S.C. 321(i). Dental products or to secure sections of fabric, of the well-documented danger to floss is considered a ‘‘device’’ under the leather, wood, paper and other children from contact with lead- FFDCA because it is ‘‘an instrument, materials. In most instances, the glue or containing paints and similar surface apparatus, implement, machine, adhesive is usually not physically coatings and past instances of children’s contrivance, implant * * * intended to exposed because the materials covering products bearing lead-containing paints affect the structure or any function of the glue or adhesive serve as barrier to or coatings despite regulations the body of man * * *’’ or, the underlying glue or adhesive. For prohibiting the practice, such materials alternatively, is intended for use in the instance, a children’s book is bound must be tested to show their compliance mitigation or prevention of disease. 21 with adhesives, but the adhesive is not with the regulations, and we have U.S.C. 321(h). Products and materials accessible because the spine is covered revised proposed § 1500.91(a) to include that are not consumer products under with paper, cloth, leather, or other the following: ‘‘Materials used in the Commission’s jurisdiction are not materials, and would not become products intended primarily for subject to section 101(a) of the CPSIA, physically exposed through reasonably children 12 and younger that are treated and testing of these products and foreseeable use and abuse of the or coated with paint or similar surface- materials are not required under section product. As set forth in the coating materials that are subject to 16 102(a) of the CPSIA. Such cosmetics and inaccessibility rule, manufacturers of CFR part 1303, must comply with the devices would, instead, be subject to the children’s products should use the requirements for lead paint under requirements of the FFDCA. Commission accessibility probes section 14(a) of the Consumer Product specified for sharp points or edges at 16 5. Glues and Adhesives Safety Act (CPSA), as amended by CFR 1500.48 through 1500.49, and the section 102(a) of the CPSIA.’’ A number of commenters sought use and abuse tests specified in 16 CFR determinations for glues and adhesives. 1500.50 through 1500.53 to determine 8. Other Metals Including Titanium, Certain glues are made entirely from whether glue or adhesives, or other Aluminum, Pewter, Copper natural materials, such as animal glue. components, would be accessible to Some commenters requested that Accordingly, animal glue has been children. certain other metals, including stainless added under new § 1500.91(d)(8). steel, titanium, aluminum, pewter and However, we did not receive specific 6. Composite Wood Products copper be added to the list of data regarding specific formulations of Several commenters stated that wood determinations. individual glues and adhesives; is not expected to contain lead while We agree, in part, with the therefore we cannot make determination other commenters asked us to expand commenters that stainless steel (with regarding the entire category of glues the determination to include related the exception of one stainless steel and adhesives that may be available in products, such as composite wood alloy) and titanium should be added to

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the list of determinations. [Ref. 6]. semiprecious gems, other minerals and detailed information and test data Stainless steel is a generic name for items found in the earth, such as rocks regarding lead in ceramic ware, the corrosion-resistant steel alloys. or fossils, should be determined to Commission will continue to require the Typically, the manufacturing process for contain lead below the lead content testing and certification requirements stainless steel uses recycled scrap as limits. under section 102 of the CPSIA. well as ‘‘virgin’’ (newly refined) steel, As with the precious gemstones and 11. Glass, Crystals, and Rhinestones yet the manufacturing process heats the certain semi-precious stones that the steel to temperatures high enough to Commission determines do not contain Several commenters listed glass, glass vaporize any lead and lead oxide lead at levels that exceed the CPSIA beads, rhinestones, leaded glass crystals, present. Once the steel melts, the mix is lead content limits, other rocks and and porcelain enamel as items that subjected to a vacuum, and the lead/ stones may comply with lead limits should be exempted from compliance lead oxide gases are drawn off for provided that they are not based on lead with the CPSIA requirements for lead condensation and recycling. or lead compounds and are not content or testing. Consequently, the manufacture of associated in nature with any mineral While not all glass or glass products, stainless steels results in alloys with that is based on lead or lead crystals, or rhinestones contain lead at lead concentrations less than 100 ppm. compounds. [Ref. 4]. In general, we levels that exceed the CPSIA lead limits, However, we found that one stainless agree that most minerals do not contain in the absence of tests or other data on steel alloy, designated as 303Pb, does lead. these products, we cannot verify that contain lead. The concentration of lead However, some minerals are known to such products meet the CPSIA’s lead in 303Pb stainless steel is between contain lead or are associated in nature content limits. Further, many leaded 0.12% and 0.30% (1200 to 3000 ppm). with minerals than contain lead. We glass crystals and other glass-based The Unified Numbering System have previously identified minerals that products contain lead at levels designation for 303Pb steel is S30360. can contain lead, such as aragonite, exceeding the statutory limits and, Thus, 303Pb stainless steel is excluded bayldonite, boleite, cerussite, croroite, therefore, cannot be included in a from any determination for stainless linarite, mimetite, phosgenite, determination that they do not and steel. The Commission has revised vanadinite, and wufenite. We have also would not contain lead. We also note proposed § 1500.91(d)(1) (now identified galena, and will add this that, on July 17, 2009, the Commission renumbered as § 1500.91(e)(1)) to add mineral to the list of lead-containing voted 2–1 to deny a request to exclude ‘‘other stainless steel within the minerals under section 1500.91(d)(2). crystal and glass beads, including designations of Unified Numbering Accordingly, these minerals are rhinestones and cubic zirconium, from System, UNS S13800–S66286, not specifically excluded from the the lead content limits. The including the stainless steel designated determinations regarding minerals Commissioners’ statements as 303Pb (UNS S30360).’’ generally, and would require testing if accompanying that decision can be Titanium (both a- and b-phase) uses they are used in any children’s products found at: http://www.cpsc.gov/about/ elements such as aluminum, gallium, to assess whether they are under the cpsia/sect101.html#statements. oxygen, nitrogen, molybdenum, lead content limits. 12. Pencils, Crayons, Other Materials vanadium, tungsten, tantalum, and 10. Ceramic Glaze and Clay Regulated as Art Materials silicon as alloying materials. Lead is considered an undesired impurity and A few commenters claimed that Some commenters requested that is not found in titanium alloys. In all of ceramic glazes and clays comply with certain art materials be determined to the titanium alloys examined, we did lead limits. not contain lead at levels that exceed not find an instance where lead was a We are aware that some products or the CPSIA lead limits. constituent. Consequently, the materials used in ceramics production The CPSIA’s requirements for lead Commission has revised proposed do not contain lead or use lead-free content are in addition to other statutory § 1500.91(d)(2) (now renumbered as glazes, but others are known to contain and regulatory requirements for § 1500.91(e)(2)) to add ‘‘titanium’’ to the lead at levels that exceed the CPSIA children’s art materials. Compliance list of determinations on precious limits for lead content. Lead in ceramic under the Labeling of Hazardous Art metals. ware typically comes from the varnish Materials Act (LHAMA) (15 U.S.C. As for other metals and alloys, or glaze applied to give a shiny finish 1277) requires the submission of art including aluminum, copper and to the product. In addition, certain material product formulations to a pewter, such metals and alloys may colorants used in decoration may toxicologist for review to assess chronic contain significant amounts of lead, and contain lead pigments. Without the adverse health effects through we cannot verify that the specific required testing of ceramic glazes and customary or reasonably foreseeable products containing such metals or other materials, compliance with the use. If the toxicologist determines that alloys comply with the lead content lead content limits of the CPSIA cannot the art material has this potential, the limits without testing. (See e.g., be verified for the myriad of products producer or repackager must use American Society for Metals: Metals that are available. Moreover, in the Joint cautionary labeling on the product in Handbook, Properties and Selection: Conference Report, H.R. Rep. No. 110– accordance with the requirements set Nonferrous Alloys and Pure Metals, 9th 787, the conferees stated under the forth at 16 CFR 1400.14(b)(8), and ed., v.2 (1979).) Accordingly, these other section titled Special Issues that they section 2(p) of the FHSA, 15 U.S.C. metals and alloys continue to be subject ‘‘believe the Commission should take 1261(p). Any art material intended for to the testing and certification appropriate action with respect to lead children that is or contains a hazardous requirements of section 102 of the included in any ceramic product within substance (by reason either of chronic or CPSIA. its jurisdiction.’’ Conference Report on acute toxicity) would be a banned H.R. 4040, Consumer Product Safety hazardous substance under section 9. Other Minerals and Items Found in Improvement Act of 2008, 154 Cong. 2(q)(1)(A) of the FHSA, 15 U.S.C. the Earth Rec. H7214 (daily ed. July 29, 2008). 1261(q)(1)(A). Art supplies that are Several commenters stated that, in Accordingly, for children’s ceramic intended primarily for use by children addition to certain precious and ware, until the Commission receives must also comply with the lead content

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limits under section 101(a) of the not introduce lead or result in an end made soluble in water or another carrier CPSIA. Accordingly, without receiving product that would not exceed the so they can penetrate into the fiber. more information and data regarding the CPSIA’s lead limits. Modern textile and Dyes can be used in solutions or as a lead content of specific art materials apparel production practices are paste for printing. Commercial dyes are intended primarily for children, we are recognized and well-characterized. With classified by chemical composition or unable to make any determinations in a few uncommon exceptions, modern method of application. Many dyes are this proceeding. production practices do not involve lead fiber specific. For example, disperse or lead-based chemicals. dyes are used for dyeing polyester, and 13. Fabrics, Dyes and Similar Materials In general, textile materials and direct dyes are used for cellulosic fibers. Numerous commenters claimed that products do not contain lead and have Dyes can be applied to textiles at the many fabrics, yarns, batting, fill, and not undergone any processing or fiber, yarn, fabric, or finished product similar materials (such as ribbon), and treatment that imparts lead resulting in stage. Dye colorants are not lead based. related materials (such as elastic), a total lead content that exceeds the Although not typical, some dye baths including those that are dyed or CPSIA total lead limits. Accordingly, may contain lead. However, even if the similarly processed, do not contain lead. new § 1500.91(d)(7) adds ‘‘Textiles’’ to dye bath contains lead, the colorant that In addition, some commenters requested the list of determinations. Additionally, is retained by the finished textile after a determination that fabric dyes comply with respect to fibers from natural the rinsing process would not contain with the lead content limits. The sources, we find that natural fibers are lead above a non-detectable lead level. commenters provided data and other natural materials and do not contain In contrast to dyes, pigments are information to support their claims. lead, whether they are dyed or undyed. either organic or inorganic. Pigments are Additionally, during a public meeting [Ref. 3]. Examples of plant based fibers, insoluble in water, are applied to the held on January 22, 2009, industry from the seed, stem, or leaves of plants, surface of textile materials, and are held representatives, test laboratories, and include, but are not limited to, cotton, there by a resinous binder. Binders used stakeholders met with CPSC staff and kapok, flax, linen, jute, ramie, hemp, with pigments for textiles are non-lead presented materials and test data on kenaf, bamboo, coir, and sisal. Animal based. Processes that are lead-based are lead levels in textile and apparel fibers, or natural protein fibers, include used for some industrial textiles that products. Several hundred test reports but are not limited to silk, wool (sheep), require a greater level of colorfastness or and analyses were submitted. The tests and hair fibers from alpaca, llama, goat durability, but are not typically analyzed lead levels in various textile (mohair, cashmere), rabbit (angora), intended for apparel textiles. Although and apparel products, including a range camel, horse, yak, vicuna, qiviut, and most pigments do not contain lead, of daywear, sleepwear, and outerwear guanaco. The final rule thus adds these there may be some lead based paints garments. Tests for lead were also natural fibers to § 1500.91(d)(7)(a) and pigments on non-textile materials conducted on the many functional and (formerly proposed § 1500.91(c)(5)). that may be directly incorporated into decorative components used on apparel We also reviewed information textile products or added to the surface items. These items include adornments pertaining to fibers that are not obtained of textiles, such as decals, transfers, and (rhinestones and beads), closures and from natural sources and are classified screen printing. All such non-textile findings (buttons, snaps, and zippers), as manufactured or man-made. [Ref. 3]. components must be tested for lead trims, and fasteners. Manufactured fibers are created by content under section 102 of the CPSIA Information on the dye industry was technology and are classified as unless they are made entirely from also submitted by the Ecological regenerated, inorganic, or synthetic. materials that the Commission has Association of Dye and Organic Pigment Regenerated fibers are made from determined would not contain lead in Manufacturers (ETAD). ETAD states that natural materials that are reformed into excess of the CPSIA lead limits. Since it represents about 80% of worldwide usable fibers. These fibers include, but we are allowing the use of dyes and dye manufacturers. According to ETAD, are not limited to, rayon, azlon, lyocell, pigments on textile materials, we have 80% or more of dyes used in acetate, triacetate, and rubber. Synthetic revised proposed § 1500.91(c) (now commercial processing are organic fibers are polymers created through a renumbered as § 1500.91(d)) to remove carbon compounds and do not contain chemical process and include, but are ‘‘or chemicals such as pigments, dyes, lead. Dyes used for cotton, other not limited to, polyester, olefin, nylon, coatings, finishes or any other cellulosics, and polyester, the most acrylic, modacrylic, aramid, and substance, nor undergone any commonly used fibers for apparel, spandex. The information we have processing.’’ However, we have account for 70% of total dye indicates that manufactured fibers are excluded from ‘‘Textiles’’ under new consumption. According to ETAD, these produced in controlled environments by paragraph § 1500.91(d)(7), any textiles fibers use specific dye classes (e.g., processes that do not use lead or that are ‘‘after-treatment applications, disperse, direct, reactive) that would not incorporate lead at any time during their including screen prints, transfers, contain lead. ETAD also recommends production, whether they are dyed or decals, or other prints.’’ that its member companies follow lead undyed. Consequently, we have added c. Leather limits of 100 ppm using a sampling and these manufactured fibers as a new testing procedure that ensures the § 1500.91(d)(7)(b); specifically, the new Although leather is not made from recommended limits. provision refers to ‘‘Manufactured fibers fibers like most textiles, it may be used (dyed or undyed) including, but not to produce apparel and coverings or a. Textiles limited to, rayon, azlon, lyocell, acetate, may be used along with textile products. We reviewed the data pertaining to triacetate, rubber, polyester, olefin, Leather begins as natural products, but textile products intended for children nylon, acrylic, modacrylic, aramid, they undergo processing (e.g., tanning) and the general practices used in the spandex.’’ to convert the natural skin into a usable, textile industry and the modern durable product. Similar to most textile production and coloration of textiles b. Dyes products, leather products are often and apparel. [Refs. 1 and 3]. We We also examined the dyes used on colored with dyes or pigments during conclude that most textile products are textiles. [Refs. 1 and 3]. Dyes are organic their processing. Many of the same dyes manufactured using processes that do chemicals that can be dissolved and used in the textile industry also are used

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for dyeing leather. According to from GOTS and Oeko-Tex® would serve and pulp. Paper is predominantly made information submitted by the Leather to provide such verifications for textiles. from wood, but also may be made with Industries of America, many processes Both GOTS and Oeko-Tex® standards other cellulosic fibers. For tinting and used to process and finish leather do not limit lead content in certain textile coloring of fibers, dyes are most use lead or lead-based chemicals. products to no more than 100 ppm lead. commonly used. Dyes, especially basic However, many leather products may dyes and direct dyes, are relatively 14. Book Components be finished with pigment-based inexpensive and widely available and coatings, including some that are Several commenters, such as used in easily processed forms which colored using lead-based pigments. associations for the publishing, printing, are highly substantive to fiber and [Refs. 1 and 3]. Currently, any children’s and paper industries, and libraries, produce a uniform color or shade and leather product that has paint or a asked us to determine that ‘‘ordinary which can be varied easily to achieve similar surface-coating material is books’’ are within the CPSIA’s lead whatever shades are needed. subject to the lead paint ban at 16 CFR content limits. The Association of Pigments, particularly inorganic part 1303. Products that are finished American Publishers (AAP) defined pigments, are comparatively expensive with such coatings are subject to the ‘‘ordinary books’’ to mean paper-based, and difficult to use due to their density. testing and certification for lead paint printed books that are designed or Complex chemistry must be added to under section 102 of the CPSIA. Section intended primarily for 12 years and get the pigments to retain the pigments 1303.2 (Definitions) specifically younger. AAP states that it does not with the fibers and not have them drain provides that paint or other similar intend the term to include so-called out. The comparative expense and surface coating includes application on ‘‘novelty’’ products such as, for difficulty involved in the use of wood, stone, paper, leather, cloth, example, plastic-based bath toys or inorganic pigments for coloration limits plastic or other surface. The treatment teething products that are made to their use to highly-specialized grades of that could potentially impart lead onto resemble books in shape and form, or paper, such as for laminate countertop leather is the application of leaded books that have plastic, metal or and flooring applications where the pigment onto the surface of the leather electronic parts that are not part of the decorative layer must be lightfast, product. We deleted the term binding and with which children may durable, and be able to withstand the ‘‘untreated’’ before the word ‘‘leather’’ be expected to interact. According to the heat and chemical conditions of the from former § 1500.91(c)(6) (now commenters, ordinary books generally resin-impregnation stage to convert renumbered as § 1500.91(d)(8)) because, consist of papers, inks, coatings, layers of paper into a countertop, such as discussed in part D.7 of this adhesives, and bindings. We held three as Formica®. Such specialty papers are preamble, § 1500.91(a) makes explicit public meetings with representatives of not expected to be used for ordinary that the determinations do not cover any these industries on January 22, 2009, printing and writing purposes. As with material in a children’s product that has June 9, 2009, and August 11, 2009, in the fibers and textiles, paper and similar paint or similar surface-coating Bethesda, Maryland. cellulosic materials, including the dyes materials subject to 16 CFR part 1303. Under section 101(a) of the CPSIA, and treatments used to make them, are Such materials and products must the Commission is required to evaluate not expected to contain lead above the comply with the testing and the lead content limit for any part of a CPSIA lead limits. Accordingly, we certification requirements for lead paint product. Accordingly, we must assess have added paper and similar materials under section 102 of the CPSIA. whether each part of a children’s book made from wood or other cellulosic would contain lead over the lead fiber, including, but not limited to, d. Other Comments content limits. Therefore, we reviewed paperboard, linerboard, and medium to Several commenters, including the comments, data, and other information a new § 1500.91(d)(5). Organic Trade Association, stated that regarding papers, inks, coatings, b. Printing Inks and Coatings certifications based on standards such adhesives, and bindings to assess as the Global Organic Textile Standard whether those components could With respect to inks, the commenters ® (GOTS) and Oeko-Tex should be contain lead over the lead content noted that, in theory, lead pigments can allowed in place of testing for limits. be used in any printing process; compliance with the CPSIA lead content however, in practice, lead has been requirements. a. Paper eliminated from all but a few limited Because the Commission has Several commenters stated that paper applications such as outdoor signage, determined that textiles fall under the is derived from natural wood, which labels used in harsh environments, or lead content limits, the Commission inherently has a de minimis level of other applications where the product’s will not require testing on textiles under total lead content, and that the primary ability to withstand the weather is a section 102 of the CPSIA. However, components in the production of paper critical factor. The commenters stated even when a particular product or are wood fiber and water. They stated that, as a practical matter, lead-based or material has been relieved of the that lead-based chemicals are not lead-containing inks are not used in requirement to undergo testing and introduced in the major phases of the modern printing processes. They certification under section 102 of the paper manufacturing process (i.e., wood explained that the regulations CPSIA, manufacturers and importers are preparation/pulping; bleaching/refining; promulgated under the Resource responsible for verifying that the running of the paper machine; and Conservation and Recovery Act of 1976 material or product has not been altered finishing processes, including coating). (RCRA) (40 CFR part 261.24) require or modified, or experienced any change After review of the test data and other that any waste, include printing ink, in the processing, facility or supplier information submitted by the which contains lead in an amount conditions that could impart lead into commenters, we have determined that exceeding five (5) ppm must be treated the material or product and ensure that paper and similar cellulosic materials as hazardous waste. They also pointed the material or product meets the do not contain lead in excess of the to regulations promulgated under the statutory lead levels at all times. With CPSIA’s lead content limits. [Refs. 1 and Occupational Safety and Health Act respect to the GOTS and Oeko-Tex® 5]. Paper products include paper, (OSHA) (29 CFR 1910.1025) which standards, we believe that certifications paperboard, linerboard and medium, requires workplaces in which lead is

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used to maintain five (5) micrograms/ materials printed using only the CMYK inks, inks used in any after-treatments, cubic meter or less permissible exposure processes. We confirmed that such as screen prints, decals, transfers, limits in workplace air environments, as transparent pigments or dyes are used in and other prints will be excluded from well as the Coalition of Northeastern CMYK process inks and that leaded the determinations under new Governors (CONEG) standard, known as pigments, which are opaque, are not § 1500.91(d)(6). the Model Toxics in Packaging compatible with ‘‘process inks.’’ Transparent or other coatings which Legislation which has been adopted as Accordingly, we added to the list of soak into the substrate are not packaging regulations by 19 states and determinations CMYK process printing considered to be a surface coating for the European Union, as factors inks under a new § 1500.91(d)(6). [Ref. the purpose of 16 CFR part 1303 discouraging the use of lead-based and 1]. because they become part of the lead-containing inks in ‘‘ordinary’’ On the other hand, lead-based inks substrate (16 CFR 1303.3(b)(1)). As books. Specifically, they stated that the could be used for spot colors, including discussed in part D.14(a) of this CONEG standard was designed to phase spot colors used in conjunction with the preamble, the comparative expense and out the use and presence of mercury, CMYK process (sometimes referred to as difficulty of using inorganic pigments lead, cadmium, and hexavalent CMYK plus spot). Spot colors are only for coloration is a deterrent for ordinary chromium in packaging and packaging used when a specific color cannot be printing and writing purposes. materials and prescribes combined reproduced with the CMYK process Similarly, paper coatings that use limits for all four of these heavy metals colors; however, unlike CMYK process leaded pigments for coloring would not that are lower than the CPSIA’s lead colors, spot colors could contain leaded be found for ordinary grades of paper. content limits. According to the pigments. [Ref. 1]. Although the [Ref. 5]. Because such coatings do not commenters, the CONEG standard has commenters state that, ‘‘[s]pot colors, contain lead, insofar as printing is been widely adopted by the children’s which could use lead chromate concerned, they do not require testing book publishing industry. pigments, have been phased out due to under section 102 of the CPSIA. The commenters also stated that lead- safety and environmental concerns’’ Accordingly, we added to the list of based pigments are not compatible with (Letter from American Publishers determinations on paper under new the four-color process. This process, Association to Kristina M. Hatlelid, § 1500.91(d)(5), ‘‘and coatings on such commonly called CMYK, uses Consumer Product Safety Commission, paper which become part of the transparent cyan (C), magenta (M), and July 1, 2009), the Commission can only substrate.’’ yellow (Y) inks, in addition to black ink, verify that such leaded pigments were Other additional treatments such as to create a wide range of colors. The not used through additional testing. laminates, including plastic sheet or comments indicated that lead could be Accordingly, new § 1500.91(d)(6) film, or other coatings, such as foils, that used in ‘‘spot colors’’ and described specifies that spot colors, other inks that do not become part of the substrate also several lead-based pigments, but are not used in the CMYK process, and would continue to require testing and claimed that the use of the lead inks that do not become part of the certification under section 102 of the pigments is not current practice because substrate under 16 CFR part 1303 are CPSIA. Although commenters sought of safety and environmental concerns. excluded from the determinations. Inks determinations for these materials, their The commenters also explained that the that do not become part of the substrate test data indicates that some of these types of printing inks that might contain are considered to be paints or similar coating materials contain PVC. As lead, such as for screen-printing and for surface-coating material under 16 CFR discussed in part D of this preamble, the certain processes for printing on plastic part 1303 and currently require Commission has found that some or other non-paper materials, are certification based on third-party testing products made of PVC can contain lead. specifically designed for those purposes by an accredited laboratory. In addition, the commenters have and cannot be used for printing In addition, as discussed in part D.13 described foils to be made primarily of children’s paper-based books and of this preamble, we have found that aluminum. Part D.8 of this preamble similar paper-based materials because certain after-treatments, including discusses other metals, including different printing processes require screen printing, may use leaded aluminum, which can contain lead. different ink systems. pigments. The commenters state that Because the lead content of such items We evaluated printing inks, which are screen printing inks use four major cannot be verified without testing, the distinct from the dyes used to color types of ink systems: UV inks, water- Commission cannot make a paper and textiles. Data and information based ink, plastisols, and the solvent- determination that all laminates and provided in response to the notice of based ink systems. The Commission other surface coatings would not proposed rulemaking, at CPSC public cannot determine that all screen contain lead below the lead content meetings with members of the printing inks do not contain lead below limits, and thus, such materials must be publishing and printing industries the lead content limits. Plastisol inks are tested under section 102 of the CPSIA. (January 22, 2009, June 9, 2009, August made with PVC, and, as stated earlier in 11, 2009), and in written materials part D of this preamble, PVC may c. Adhesives and Binding Materials following those public meetings contain lead. As discussed in part D of Some commenters stated that the indicate that the use of lead in printing this preamble, the Commission will not post-press step involves folding, cutting inks has largely been eliminated, except make determinations for any materials and binding of collated sections into a for certain inks formulated for use in that have been found to contain lead. finished product. According to the printing on materials such as plastic or The Commission recognizes that not all commenters, the binding can be done fabric, including screen printing. Lead- products made of PVC contain lead, but either mechanically or chemically with based pigments are not compatible with to verify that a component part does not hot-melt or cold glue adhesives, sewing the four-color process (and variations of contain lead, we would have to test them with polyester or cotton threads, this process, such as those that add such plastic parts to assess whether it saddle stitching them with wire or colors or diluted colors to the system to was over the lead content limits. Such stapling, or punching holes for use with improve the quality of images printed products will continue to require testing spiral wires. using CMYK). Lead would not be found under section 102 of the CPSIA. As discussed in part D.5 of this in paper or similar paper-based Accordingly, except for CMYK process preamble, we find that most adhesives

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in books would not require testing and its fluidity which would result in a this bill.’’ H.R. 92–1153, 92nd Cong. (2d certification under section 102 of the more uniform coating. The added lead Sess. 1972). The Commission’s CPSIA. We have determined that animal could be as high as 16,000 ppm or as authority, therefore, applies to glues and threads would not contain low as 100 ppm. Although there are consumer products, including lead above the lead content limits. In lead-free galvanizing techniques that children’s products, that are distributed addition, most adhesives used in require more refinement (washing, in commerce, whether or not such books children’s products, including prefluxing, preheating, etc.), the are sold or lent, if they are for the use children’s books, would not be Commission cannot tell which of a child. accessible under the guidance provided processes are being used without testing According to ALA, library books by the Commission in the inaccessibility the components. Because these metals should not become a ‘‘hazardous rule. To the extent that any such could contain lead, the Commission substance’’ unless they are adhesive is not covered in the cannot make determinations that they ‘‘reintroduced’’ into interstate determinations and is accessible, (i.e. fall below the lead content limits. commerce after the effective dates of the not covered by any other material), it, Accordingly, the Commission will lead limits. Children’s products are too, would be subject to the testing and continue to require testing and consumer products that are distributed certification requirements of section 102 certification on the components parts in interstate commerce regardless of of the CPSIA. that have been found to or may contain when they are introduced, and the Certain binding materials also may be lead including plastic parts, metal parts, FHSA does not limit the definition of a inaccessible if they are enclosed or and paints and similar surface-coating banned hazardous substance to new encased by material which does not materials subject to 16 CFR part 1303. products or to the product’s first permit physical contact with that introduction of such a product into component part. However, for binding d. Older Books interstate commerce. Under section materials that are accessible and contain Comments were received from the 2(q)(1) of the FHSA, 15 U.S.C. plastic or metal parts (for which a American Library Association (ALA) 1261(2)(q)(1), a ‘‘banned hazardous determination has not been made), the requesting that books available in substance’’ is any toy, or other article Commission will continue to require libraries not be subject to the CPSIA intend for use by children, which is a testing and certification under section lead content requirements. In general, banned hazardous substance, or which 102 of the CPSIA. Although AAP sought ALA claimed that children’s books fall bears or contains a hazardous substance determinations on plastic and metal outside of the scope of the CPSIA wire binding, it did not explain why the because they are not distributed in in such manner as to be susceptible of plastic or metal in those products are interstate commerce. ALA also stated access by a child to whom such toy or distinct or unique from what they that libraries should not be required to other article is entrusted. Section 4(b) of describe as ‘‘novelty books that have test books that are on the shelf, even the FHSA explicitly prohibits ‘‘[t]he plastic, metal or electronic parts with new books, given libraries’ limited alteration, mutilation * * * with which children may be expected to resources. respect to, a hazardous substance, if interact.’’ Although the commenters We disagree with the commenters such act is done while the substance is claim that all of their materials are regarding libraries and the CPSIA. in interstate commerce, or while the CONEG compliant, the certification of Although ALA requested an exemption substance is held for sale (whether or compliance under CONEG is currently from the testing requirements for lead not the first sale)’’ (emphasis added). In based on self-certification by the content, ALA may have misinterpreted addition, section 4(c) of the FHSA supplier or manufacturer and not based the testing requirements. Currently, only further prohibits ‘‘[t]he receipt in on a third-party certification by a CPSC manufacturers and importers of interstate commerce of any misbranded accredited laboratory as required under children’s products are required to hazardous substance or banned section 102 of the CPSIA. Accordingly, obtain testing showing compliance with hazardous substance and the delivery or the Commission cannot adopt those CPSIA lead limits. (See Final Rule on proffered delivery thereof for pay or certifications in lieu of the certifications Certificates of Compliance, 74 FR 68328 otherwise’’ (emphasis added.) Under required under the CPSIA. (November 18, 2008)). A library is section 101(a) of the CPSIA, Congress Although the commenters seek neither a manufacturer nor an importer, has deemed that children’s products determinations for metal wire so it is not required to test products that do not meet the lead content limits saddlestitch and spiral binding as well before their sale or distribution. within the specified dates ‘‘to be banned as plastic spiral binding, as discussed in ALA also argues that library books are hazardous substances.’’ Accordingly, part D of this preamble, the Commission not ‘‘distributed’’ in interstate the Commission may not provide relief has found that certain plastic commerce. ALA suggests that because from the lead content limits except components have contained lead due to children’s library books are not sold, under the specific exclusions provided the addition of certain additives or therefore, they are not distributed. As under section 101(b) of the CPSIA. colorants. In addition, the Commission explained in the House Report No. 92– Absent a finding that all used children’s has found that many metals can contain 1153 accompanying the Consumer books fall within the scope of an lead and has even banned certain metal Product Safety Act of 1972, the exclusion, the Commission is bound by components, such as metal-cored wicks definition of ‘‘consumer product’’ was the statutory language of the CPSIA. over 600 ppm. Although commenters not limited to the sale of a product to Unfortunately, the Commission is state that their metal components are a consumer. ‘‘It is not necessary that a unable to make such a determination in lead-free because, among other things, product be actually sold to a consumer, this proceeding. Because older books they are made of carbon steel and but only that it be produced or have not been manufactured using galvanized zinc, carbon steel distributed for his use. Thus products modern printing processes, such as the components often have lead added to it which are manufactured for lease and CMYK color process, and have been to improve machinability and impart products distributed without charge (for found, in some circumstances, to other properties. In addition, there are promotional purposes or otherwise) are contain leaded ink or components, the zinc plating processes that add lead to included within the definition and Commission is unable to make a improve its surface tension and increase would be subject to regulation under determination that the components of

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all older children’s books fall under the apparel accessories, such as zippers, stated that the CPSIA would have lead content limits. buttons, snaps, and grommets. devastating economic consequences for For older used children’s books that In general, plastic, metal, and painted small businesses that cannot afford to are sold, many of these books may be materials and products (for which test their products. determinations have not been made) collector’s items that are sold to adults. These commenters have have been found, in certain instances, to Such books would not be considered to misinterpreted the Regulatory contain lead at levels that exceed the be intended primarily for children, and Flexibility Act (RFA) section of the CPSIA lead limits. Data provided in accordingly, may continue to be sold to proposed rule. That section did not response to the proposed rule and at the adults. For older used children’s books address the impact of the CPSIA on CPSC public meeting with members of that are lent out, ALA has requested small businesses; that section addressed additional guidance regarding the the textile industry showed that some items, such as zippers, buttons, and what impact the proposed rule on the treatment of these products. determinations would have on small Accordingly, the Commission intends to other applied decorations, currently contain lead levels that exceed the businesses. The Commission does not issue a separate Statement of Policy have the authority to change the CPSIA. addressing the treatment of older CPSIA’s lead content levels. In addition, based on the Commission’s past However, under the general rulemaking children’s books. experience with other children’s authority vested to the Commission 15. Issues Related to Component Part products that have been found to under section 3 of the CPSIA, the Testing contain lead, the Commission cannot Commission has the authority to make a determination that any promulgate a rule to determine that a. Material Safety Data Sheet (MSDS) component parts made out of plastic or certain products or materials would not Some commenters indicated that the metal (with the exception of metal exceed the lead content limits. When an materials they use should not require determinations made in this rule) are agency issues a proposed rule, it must testing because the material safety data below the lead content limits. prepare an initial regulatory flexibility sheets (MSDS) already show that the Accordingly, these products and analysis describing the impact the materials do not contain lead. materials continue to be subject to the proposed rule is expected to have on small entities. 5 U.S.C. 603. The RFA As the Commission stated in the lead content limits of section 101(a) of does not require a regulatory flexibility procedures rule, material safety data the CPSIA, as well the testing and analysis if the head of the agency sheets are insufficient for purposes of certification requirements of section 102 certifies that the rule will not have a demonstrating compliance with the lead of the CPSIA. The Commission is aware that there significant effect on a substantial limits under the CPSIA (74 FR at are many questions regarding number of small entities. 10478). Since regulations concerning component part testing and certification MSDS require reporting only for The Commission’s Directorate for for lead content given that any Economic Analysis prepared a chemicals with content levels that children’s product may be made with a exceed 1000 ppm, the MSDS sheets preliminary assessment of the impact of number of materials and component relieving certain materials or products cannot be used to show that a product parts. The questions regarding testing complies with the lead limits of the from the testing requirements of section and certification are significant because 102 of the CPSIA if they were found to CPSIA, which are 600 ppm for products not all component parts may need to be sold after February 10, 2009, 300 ppm be inherently under the lead content tested if they fall under the scope of the limits prescribed. [Ref. 7]. The number for products sold after August 14, 2009, exclusions approved by the and 100 ppm for products sold after of small businesses that will be directly Commission. For example, component affected by the rule is unknown, but August 14, 2011 (if deemed to be parts would not need to be tested if could be considerable. However, the technologically feasible). they: (1) Are inaccessible, as set forth final rule will not result in any increase under the Commission’s regulations at b. Metal, Plastic and Painted in the costs of production for any firm. 16 CFR 1500.87; (2) are or contain an Components Its only effect on businesses, including electronic device exempt under the small businesses, will be to reduce the Many commenters requested a testing Commission’s regulations at 16 CFR costs that would have been associated exemption for certain metal and plastic 1500.88; or (3) are made of material with testing the materials under section items, such as buttons, zippers, snaps, determined by the Commission to fall 102 of the CPSIA. Based on the grommets, eyelets, head bands, hair under lead content limits in this rule (to foregoing assessment, the Commission combs and clips, and barrettes. Other be codified as 16 CFR 1500.91(a)–(e)(2). certifies that the rule would not have commenters mentioned products such However, all other component parts will significant impact on a substantial as plastic hangers, dolls and doll need to tested and certified under number of small entities. accessories (such as shoes and section 102 of the CPSIA. The eyeglasses), pipe-stem cleaners, brass or Commission intends to address F. Environmental Considerations other metal bells, beading wire, and component part testing and the certain construction materials such as establishment of protocols and Generally, CPSC rules are considered Plexiglas and aluminum screening. standards for ensuring that children’s to ‘‘have little or no potential for Some commenters listed fasteners, such products are tested for compliance with affecting the human environment,’’ and as nails, screws, or plastic fasteners, as applicable children’s products safety environmental assessments are not items that should be exempted from rules, as well as products that fall usually prepared for these rules (see 16 compliance with CPSIA requirements. within an exemption, in an upcoming CFR 1021.5(c)(1)). The determinations Most commenters did not provide test rulemaking. rule is not expected to have an adverse data or other information about the lead impact on the environment, thus, the content of these types of products. E. Impact on Small Businesses Commission concludes that no However, some commenters from the A few commenters stated that the new environment assessment or apparel industry acknowledged that rule would have a significant impact on environmental impact statement is lead has been found sometimes in small businesses. These commenters required in this proceeding.

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G. Executive Orders PART 1500—HAZARDOUS section 101(a) of the CPSIA provided According to Executive Order 12988 SUBSTANCES AND ARTICLES: that these materials have neither been (February 5, 1996), agencies must state ADMINISTRATION AND treated or adulterated with the addition in clear language the preemptive effect, ENFORCEMENT REGULATIONS of materials that could result in the addition of lead into the product or if any, of new regulations. The ■ 1. The authority for part 1500 preemptive effect of regulations such as material: continues to read as follows: (1) Precious gemstones: diamond, this proposal is stated in section 18 of Authority: 15 U.S.C. 1261–1278, 122 Stat. ruby, sapphire, emerald. the FHSA. 15 U.S.C. 1261n. 3016. (2) Semiprecious gemstones and other H. Effective Date ■ 2. Add a new § 1500.91 to read as minerals, provided that the mineral or material is not based on lead or lead The Administrative Procedure Act follows: compounds and is not associated in requires that a substantive rule must be § 1500.91 Determinations regarding lead nature with any mineral based on lead published not less than 30 days before content for certain materials or products or lead compounds (excluding any its effective date, unless the rule relieves under section 101 of the Consumer Product mineral that is based on lead or lead a restriction. 5 U.S.C. 553(d)(1). Because Safety Improvement Act. compounds including, but not limited the final rule provides relief from (a) The Consumer Product Safety to, the following: aragonite, bayldonite, existing testing requirements under the Improvement Act provides for specific boleite, cerussite, crocoite, galena, CPSIA, the effective date is August 26, lead limits in children’s products. linarite, mimetite, phosgenite, 2009. Section 101(a) of the CPSIA provides vanadinite, and wulfenite). I. References that by February 10, 2009, products (3) Natural or cultured pearls. designed or intended primarily for (4) Wood. The following references are available children 12 and younger may not (5) Paper and similar materials made from the Commission’s Office of the contain more than 600 ppm of lead. from wood or other cellulosic fiber, Secretary, Consumer Product Safety After August 14, 2009, products including, but not limited to, Commission, 4330 East West Highway, designed or intended primarily for paperboard, linerboard and medium, Bethesda, MD 20814; telephone 301– children 12 and younger cannot contain and coatings on such paper which 504–7923; or e-mail: [email protected] more than 300 ppm of lead. On August become part of the substrate. or from the Commission’s Web site 14, 2011, the limit may be further (6) CMYK process printing inks (http://www.cpsc.gov/library/foia/ reduced to 100 ppm, unless the (excluding spot colors, other inks that foia09/brief/leadfinalrule.pdf). Commission determines that it is not are not used in CMYK process, inks that 1. Memorandum from Kristina M. Hatlelid technologically feasible to have this do not become part of the substrate and Robert J. Howell, ‘‘Consumer lower limit. Paint, coatings or under 16 CFR part 1303, and inks used Product Safety Improvement Act of 2008 electroplating may not be considered a in after-treatment applications, (CPSIA)—Determination of Lead Content barrier that would make the lead including screen prints, transfers, for Certain Products and Materials,’’ content of a product inaccessible to a decals, or other prints). August 6, 2009. child. Materials used in products (7) Textiles (excluding after-treatment 2. Memorandum from Kristina M. Hatlelid to Mary Ann Danello, ‘‘Response to Public intended primarily for children 12 and applications, including screen prints, Comments: Determinations,’’ August 6, younger that are treated or coated with transfers, decals, or other prints) 2009. paint or similar surface-coating consisting of: 3. Memorandum from Allyson Tenney to materials that are subject to 16 CFR part (i) Natural fibers (dyed or undyed) Kristina Hatlelid, ‘‘Textiles and Apparel 1303, must comply with the including, but not limited to, cotton, Subject to the CPSIA,’’ June 5, 2009. requirements for lead paint under kapok, flax, linen, jute, ramie, hemp, 4. Memorandum from Mark F. Gill to Kristina section 14(a) of the Consumer Product kenaf, bamboo, coir, sisal, silk, wool M. Hatlelid, ‘‘Results of Research on Safety Act (CPSA), as amended by (sheep), alpaca, llama, goat (mohair, Lead Content in Slate,’’ July 22, 2009. section 102(a) of the CPSIA. cashmere), rabbit (angora), camel, horse, 5. Memorandum from Joel Recht to Kristina (b) Section 3 of the CPSIA grants the Hatlelid, ‘‘Lead in Paper,’’ July 15, 2009. yak, vicuna, qiviut, guanaco; 6. Memorandum from Randy Butturini to Commission general rulemaking (ii) Manufactured fibers (dyed or Kristina M. Hatlelid, ‘‘Lead in Stainless authority to issue regulations, as undyed) including, but not limited to, Steel and Titanium Alloys,’’ June 3, necessary, either on its own initiative or rayon, azlon, lyocell, acetate, triacetate, 2009. upon the request of any interested rubber, polyester, olefin, nylon, acrylic, 7. Memorandum from Robert Franklin to person, to make a determination that a modacrylic, aramid, spandex. Kristina Hatlelid, ‘‘Final regulatory material or product does not exceed the (8) Other plant-derived and animal- analysis of a rule making determinations lead limits as provided under paragraph derived materials including, but not that certain materials or products do not (a) of this section. limited to, animal glue, bee’s wax, have lead contents that exceed the limits (c) A determination by the seeds, nut shells, flowers, bone, sea established in section 101(a) of the Commission under paragraph (b) of this shell, coral, amber, feathers, fur, leather. CPSIA,’’ July 17, 2009. section that a material or product does (e) The following metals and alloys do List of Subjects in 16 CFR Part 1500 not contain lead levels that exceed 600 not exceed the lead content limits under ppm, 300 ppm, or 100 ppm, as section 101(a) of the CPSIA, provided Consumer protection, Hazardous applicable, does not relieve the material that no lead or lead-containing metal is materials, Hazardous substances, or product from complying with the intentionally added but does not Imports, Infants and children, Labeling, applicable lead limit as provided under include the non-steel or non-precious Law enforcement, and Toys. paragraph (a) of this section if the metal components of a product, such as J. Conclusion product or material is changed or solder or base metals in electroplate, altered so that it exceeds the lead clad, or fill applications: ■ For the reasons stated above, the content limits. (1) Surgical steel and other stainless Commission amends title 16 of the Code (d) The following materials do not steel within the designations of Unified of Federal Regulations as follows: exceed the lead content limits under Numbering System, UNS S13800–

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S66286, not including the stainless steel 463 (5 U.S.C. app.), and the Federal oncology, pulmonology, cardiology, designated as 303Pb (UNS S30360). Advisory Committee Act, which sets toxicology, pharmacology, addiction, or (2) Precious metals: Gold (at least 10 forth standards for the formation and any other relevant specialty. One karat); sterling silver (at least 925/1000); use of advisory committees. The member shall be an officer or employee platinum; palladium; rhodium; osmium; committee advises the Commissioner or of a State or local government or of the iridium; ruthenium, titanium. designee in discharging responsibilities Federal Government. The final voting Dated: August 19, 2009. as they relate to the regulation of member shall be a representative of the Alberta E. Mills, tobacco products. general public. In addition to the voting The committee reviews and evaluates members, the committee shall include Acting Secretary, Consumer Product Safety safety, dependence, and health issues Commission. three nonvoting members who are relating to tobacco products and [FR Doc. E9–20589 Filed 8–25–09; 8:45 am] identified with industry interests. These provides appropriate advice, members shall include one BILLING CODE 6335–01–P information, and recommendations to representative of the tobacco the Commissioner. manufacturing industry, one Specifically, the committee will representative of the interests of tobacco DEPARTMENT OF HEALTH AND submit reports and recommendations on growers, and one representative of the HUMAN SERVICES tobacco-related topics, including the interests of the small business tobacco following: Food and Drug Administration • manufacturing industry. This final The impact of the use of menthol in position can be filled on a rotating, cigarettes on the public health, 21 CFR Part 14 sequential basis by representatives of including such use among children, different small business tobacco [Docket No. FDA–2009–N–0381] African Americans, Hispanics and other manufacturers based on areas of racial and ethnic minorities; expertise relevant to the topics being Advisory Committee; Tobacco • The nature and impact of the use of considered by the committee. Products Scientific Advisory dissolvable tobacco products on the Committee; Establishment public health, including such use on The Commissioner or designee shall children; designate one of the voting members of AGENCY: Food and Drug Administration, • The effects of the alteration of the committee to serve as chairperson. HHS. nicotine yields from tobacco products As added by section 917 of the Family ACTION: Final rule. and whether there is a threshold level Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387q(d)(3) SUMMARY: The Food and Drug below which nicotine yields do not product dependence on the tobacco provides that section 14 of the Federal Administration (FDA) is announcing the Advisory Committee Act does not apply Establishment of the Tobacco Products product involved; and • Any application submitted by a to this committee. Scientific Advisory Committee. These manufacturer for a modified risk Under 5 U.S.C. 553(b)(3)(B) and (d) actions are needed to implement the tobacco product. and 21 CFR 10.40(d) and (e), the agency Federal Food, Drug, and Cosmetic Act, The committee may provide finds good cause to dispense with notice as amended by the Family Smoking recommendations to the Secretary of and public comment procedures and to Prevention and Tobacco Control Act. Health and Human Services regarding proceed to an immediate effective date Elsewhere in this issue of the Federal any regulations to be issued under the on this rule. Notice and public comment Register, FDA is publishing two Federal Food, Drug, and Cosmetic Act and a delayed effective date are separate documents requesting and may review any applications for unnecessary and are not in the public nominations for voting and non-voting new tobacco products or petitions for interest as this final rule merely amends membership on this committee. This exemption under section 906(e) of the the information in § 14.100 to reflect the document also amends the agency’s Family Smoking Prevention and establishment of the committee. regulations to add the Tobacco Products Tobacco Control Act. The committee Therefore the agency is amending Scientific Advisory Committee (the may consider and provide § 14.100(a) as set forth in the regulatory committee) to the agency’s list of recommendations on any other matter text of this document. standing advisory committees. as provided in the Family Smoking DATES: This rule is effective August 26, Prevention and Tobacco Control Act. List of Subjects in 21 CFR Part 14 2009. The committee is being The committee shall consist of 12 Administrative practice and established and this charter will remain members including the Chair. Members procedure, Advisory committees, Color in effect until amended or terminated by and the Chair are selected by the additives, Drugs, Radiation protection. the Commissioner of Food and Drugs Commissioner or designee from among ■ (the Commissioner). Therefore, under the Federal Food, individuals knowledgeable in the fields Drug, and Cosmetic Act and under FOR FURTHER INFORMATION CONTACT: Erik of medicine, medical ethics, science, or authority delegated to the Commissioner P. Mettler, Office of Policy, Food and technology involving the manufacture, of Food and Drugs, 21 CFR part 14 is Drug Administration, 10903 New evaluation, or use of tobacco products. amended to read as follows: Hampshire Ave., Bldg. 1, Rm. 4324, Members will be invited to serve for Silver Spring, MD 20993–0002, 301– overlapping terms of up to 4 years. PART 14—PUBLIC HEARING BEFORE 796–4711, FAX: 301–847–3541, e-mail: Almost all non-Federal members of this A PUBLIC ADVISORY COMMITTEE [email protected]. committee serve as Special Government SUPPLEMENTARY INFORMATION: The Employees. The committee shall ■ 1. The authority citation for 21 CFR committee was established under 21 include nine technically qualified part 14 continues to read as follows: U.S.C. 387q, as added by section 917 of voting members, selected by the Authority: 5 U.S.C. App. 2; 15 U.S.C. the Family Smoking Prevention and Commissioner or designee. The nine 1451–1461, 21 U.S.C. 41–50, 141–149, 321– Tobacco Control Act (Public Law 111– voting members shall be physicians, 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 31). The committee is also governed by dentists, scientists, or health care U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; part 14 (21 CFR part 14), Public Law 92– professionals practicing in the area of Pub. L. 108–155.

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