[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Rules and Regulations]
[Pages 43031-43042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20589]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500


Children's Products Containing Lead; Determinations Regarding 
Lead Content Limits on Certain Materials or Products; Final Rule

AGENCY: Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Consumer Product Safety Commission (Commission) is issuing 
a final rule on determinations that certain materials do not exceed the 
lead content limits specified under section 101(a) of the Consumer 
Product Safety Improvement Act of 2008 (CPSIA).

DATE: Effective Date: This regulation becomes effective on August 26, 
2009.

FOR FURTHER INFORMATION CONTACT: Kristina Hatlelid, Ph.D., M.P.H., 
Directorate for Health Sciences, Consumer Product Safety Commission, 
4330 East-West Highway, Bethesda, Maryland 20814; telephone (301) 504-
7254, e-mail <a href="/cdn-cgi/l/email-protection#fb90939a8f979e97929fbb988b8898d59c948d"><span class="__cf_email__" data-cfemail="b3d8dbd2c7dfd6dfdad7f3d0c3c0d09dd4dcc5">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

A. Background

    Under section 101(a) of CPSIA, consumer products designed or 
intended primarily for children 12 years old and younger that contain 
more than 600 ppm of lead (as of February 10, 2009); 300 ppm of lead 
(as of August 14, 2009); and 100 ppm after three years (as of August 
14, 2011), unless the Commission determines that it is not 
technologically feasible to have this lower limit, are considered to be 
banned hazardous substances under the Federal Hazardous Substances Act 
(FHSA). Products below these lead content limits are not banned; 
however, in the absence of Commission action, these products and 
materials used to make children's products remain subject to the lead 
limits and consequently, the testing requirements of certain provisions 
of section 14(a) of the Consumer Product Safety Act (CPSA), as amended 
by section 102(a) of the CPSIA.\1\ By this rule, the products and 
materials determined by the Commission to fall under the lead content 
limits, are no longer subject to section 101(a) of the CPSIA and no 
testing of these products and materials is required under section 
102(a) of the CPSIA.
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    \1\ Currently, there is a stay of enforcement of testing and 
certification requirements of certain provisions of subsection 14(a) 
of the CPSA, as amended by section 102(a) of the CPSIA until 
February 10, 2010 (see 74 FR 6936 (February 9, 2009)). The stay does 
not cover those requirements where testing and certification was 
required by subsection 14(a) of the CPSA before the CPSIA's 
enactment, and third party testing and certification requirements 
for lead paint, full-size and non-full size cribs and pacifiers, 
small parts, metal components of children's metal jewelry, 
certifications expressly required by CPSC regulations, 
certifications required under the Virginia Graeme Baker Pool and Spa 
Safety Act, certifications of compliance required for All-Terrain 
Vehicles in section 42(a)(2) of the CPSA, and any voluntary 
guarantees provided for in the Flammable Fabrics Act.
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B. Statutory Authority

    Section 3 of the CPSIA grants the Commission general rulemaking 
authority to issue regulations, as necessary, to implement the CPSIA. 
The Commission has the authority under section 3 of the CPSIA to make 
determinations that certain commodities or classes of materials or 
products do not, and, by their nature, will not exceed the lead limits 
prescribed in section 101(a) of the CPSIA. Accordingly, in this rule, 
the Commission has determined that certain products or materials 
inherently do not contain lead or contain lead at levels that do not 
exceed the lead content limits under section 101(a) of the CPSIA. The 
effect of such a Commission determination would be to relieve the 
material or product from the testing requirement of section 102 of the 
CPSIA for purposes of supporting the required certification. However, 
if the material or product changes such that it exceeds the lead limits 
of section 101(a) of the CPSIA, then the determination is not 
applicable to that material or product. The changed or altered material 
or product must then meet the statutory lead level requirements. The 
Commission intends to obtain and test products in the marketplace to 
assure that products comply with the CPSIA lead limits and will take 
appropriate enforcement action if it finds a product to have lead 
levels exceeding those allowed by law.

C. Notice of Proposed Rulemaking

    In the Federal Register of January 15, 2009 (74 FR 2433), the 
Commission issued a notice of proposed rulemaking on preliminary 
determinations that certain natural materials do not exceed the lead 
content limits under section 101(a) of the CPSIA. The preliminary 
determinations were 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 did not undergo any processing that could result in the 
addition of lead into the product or material. These materials 
included:
    <bullet> Precious gemstones (diamond, ruby, sapphire, emerald);
    <bullet> 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 (minerals that contain lead or are associated in nature with 
minerals that contain lead include, but are not limited to, the 
following: Aragonite, bayldonite, boleite, cerussite, crocoite, 
linarite, mimetite, phosgenite, vanadinite, and wulfenite);
    <bullet> Natural or cultured pearls;
    <bullet> Wood;
    <bullet> Natural fibers (such as cotton, silk, wool, hemp, flax, 
linen); and
    <bullet> Other natural materials including coral, amber, feathers, 
fur, untreated leather.

See 74 FR at 2435.

    In addition, in the proposed rule, the Commission preliminarily 
determined that certain metals and alloys did not exceed the lead 
content limits under section 101(a) of the CPSIA provided that no lead 
or lead-containing metal is intentionally added. The metals and alloys 
considered included surgical steel, precious metals such as gold (at 
least 10 karat); sterling silver (at least 925/1000); platinum; 
palladium; rhodium; osmium; iridium; ruthenium. (See 74 FR at 2435). 
The preliminary determinations did not extend to the non-steel or non-
precious metal components of a product, such as solder or base metals 
in electroplate, clad, or fill applications.

D. Discussion of Comments to the Proposed Rule

    The proposed rule generated several hundred comments from a diverse 
range of interests, including advocacy groups, consumer groups, a 
State's attorney general's office, and small businesses including 
crafters. No comment opposed the proposed determinations, and, 
therefore, the final rule retains those determinations. The proposed 
rule considered those initial determinations in the context of whether 
the lead limits

[[Page 43032]]

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

[[Page 43033]]

under the procedures rule (see 74 FR 10475), including objectively 
reasonable and representative test results and other evidence showing 
that the product or material does not and would not exceed the lead 
content limits. The list of determinations made in this rule is not 
exhaustive; the Commission will continue to evaluate other requests on 
materials or products submitted under the procedures rule, and consider 
whether to re-evaluate a material if new evidence indicates that a re-
evaluation is warranted or the Commission receives data or information 
demonstrating that a particular material does not and would not contain 
lead. In such circumstances, the Commission will amend the rule, if 
appropriate.
    In other cases, the comments did provide test data and other 
information relevant to this proceeding, and those comments are 
addressed in parts D.1 through D.15 of this preamble below.

1. Compliance With Section 101(a) of the CPSIA

    Several commenters generally supported the reduction of potentially 
repetitive and wasteful testing of products and materials that are not 
expected to contain lead, but they stressed that the Commission should 
proceed carefully to ensure that the requirements of the law are met. 
The commenters asserted that the Commission should not only request 
data from firms, but should test children's products itself, especially 
those products that have not, to date, been subject to lead content 
requirements or testing for lead content. One commenter also stated 
that the final rule should make clear that materials that the 
Commission determines do not contain excess lead levels must still 
comply with the statutory lead content standard.
    The Commission has already indicated that it intends that all 
children's products subject to a determination must still comply with 
the lead limit in its ``Statement of Commission Enforcement Policy on 
Section 101 Lead Limits,'' dated February 6, 2009 (available on the 
CPSC's Web site at http://www.cpsc.gov/about/cpsia/101lead.pdf). 
However, the Commission agrees with the comments that the final rule 
should remind interested parties of their obligation to comply with the 
lead limits even if their products are the subject of a determination, 
and so we have amended the final rule to create a new Sec.  1500.91(c) 
(and renumbering the remaining paragraphs accordingly) stating that:

    A determination by the Commission under paragraph (b) of this 
section that a material or product does not contain lead levels that 
exceed 600 ppm, 300 ppm, or 100 ppm, as applicable, does not relieve 
the material or product from complying with the applicable lead 
limit as provided under paragraph (a) of this section if the product 
or material is changed or altered so that it exceeds the lead 
content limits.

    In addition, the Commission has in place procedures and 
requirements for a Commission determination that a specific material or 
product contains no lead or a lead level below the applicable statutory 
limit (see 74 FR 10475). Among other things, any request must be 
supported by objectively reasonable and representative test results or 
other evidence showing that the product or materials does not, and 
would not, exceed the lead limit specified in the request. 74 FR at 
10477.
    As for compliance with the statutory limits, compliance and 
enforcement activities, including market testing, have always been and 
continue to be essential to the Commission's mission. Moreover, even 
when a particular product or material has been relieved of the testing 
and certification requirements under section 102 of the CPSIA, 
manufacturers and importers remain responsible for verifying that the 
material or product has not been altered or modified, or experienced 
any change in the processing, facility or supplier conditions that 
could impart lead into the material or product to ensure that it meets 
the statutory lead levels at all times.

2. Plant and Animal Based Materials

    Many commenters asserted that there are many natural, plant or 
animal-based materials that likely do not contain appreciable lead 
content and should be suitable for use in children's products without 
testing for lead content. Materials mentioned include plants in 
general, and specifically bark, leaves, flowers and flower petals, 
seeds, cones, loofa, rattan, wicker, bamboo, bamboo fiber, plant-based 
dyes, nut shells, buckwheat hulls, essential plant oils, lavender, 
witch hazel, jute, kapok, kenaf, ramie, sisal, hemp, agave, coconut, 
soy, moss, straw, jojoba oil, and tung oil. Animal-based materials that 
were mentioned included yak, angora, mohair, llama, alpaca, bison, 
camel, guanaco, cashmere, horse hair, claws, horn, seashells, bone, 
animal glue, shellac.
    Our review showed that plant and animal-based materials generally 
do not contain lead at levels that exceed the CPSIA lead limits. [Ref. 
1]. However, we find that any determinations made regarding plant and 
animal-based materials must be confined to those materials that are 
unadulterated by the addition of chemicals and materials (such as 
paints and similar surface-coating materials, as discussed further in 
part D.7 of this preamble) since such treatments or additions may not 
comply with the lead limits without further testing. Although most 
materials identified in the comments were not specifically included in 
the proposed rule, the proposed determinations included three 
categories of natural materials with examples that are similar to many 
of these items (i.e., wood; natural fibers, including cotton, silk, 
wool, hemp, flax, and linen; other natural materials including coral, 
amber, feathers, fur, and untreated leather). Accordingly, the final 
rule includes other materials, such as plant and animal-based materials 
that have not been adulterated or modified as a new Sec.  
1500.91(d)(8). Specifically, the new provision covers ``other plant-
derived and animal-derived materials, including, but not limited to, 
animal glue, beeswax, seeds, nut shells, flowers, bone, sea shell, 
coral, amber, feathers, fur, leather.'' Leather is discussed further in 
part D.13(c) of this preamble.

3. Foodstuffs

    Some commenters stated that foodstuffs or materials suitable in 
food uses may be used in making children's products and should be 
determined to comply with lead limits given that they are largely 
natural plant or animal based materials and are considered edible or 
safe for use by consumers. Some materials mentioned included vegetable 
and nut oils, medicinal-grade mineral oil, table salt, flax seed, food 
coloring, food preservatives, cream of tartar, grain flours, dried 
beans, dried corn, millet, herbs, cherry pits, rice, seeds, milk, 
honey, beeswax, candelilla wax, and carnauba wax.
    In general, articles that fall within the statutory definition of 
``food'' under the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 
U.S.C. 321 et seq.) are excluded from the definition of ``consumer 
product'' under the Consumer Product Safety Act (CPSA). 15 U.S.C. 
2052(a)(5)(I). Section 321(f) of the FFDCA defines ``food'' as ``(1) 
articles used for food or drink for man or other animals, (2) chewing 
gum, and (3) articles used for components of any such article.'' 
Section 402(a)(1) of the FFDCA provides that a food is deemed to be 
adulterated if it contains any poisonous or deleterious substances, 
such as chemical contaminants, which may or ordinarily render it 
harmful to

[[Page 43034]]

health. Under this provision and other provisions in the FFDCA, the 
Food and Drug Administration (FDA) oversees the safety of much of the 
food supply. Accordingly, the Commission will not make determinations 
on lead content limits for foods used in consumer products. However, to 
the extent that there are materials available to manufacturers, such as 
beeswax, that are sometimes sold as food, but that are not always sold 
in a form intended for consumption, the Commission will treat such 
products as other natural materials if they are unadulterated and have 
not been treated with lead-containing material, and new Sec.  
1500.91(d)(8) specifically identifies some of those products, such as 
beeswax.

4. Cosmetics

    A few commenters suggested that determinations be made for soaps, 
lotions and dental floss.
    In general, articles that fall within the statutory definition of 
``cosmetic'' or ``device'' under the FFDCA (21 U.S.C. 321 et seq.) are 
excluded from the definition of ``consumer product.'' 15 U.S.C. 
2052(a)(5)(H). Soaps and lotions are considered cosmetics under the 
FFDCA as ``articles intended to be rubbed, poured, sprinkled, or 
sprayed on, introduced into, or otherwise applied to the human body or 
any part thereof for cleansing, beautifying, promoting attractiveness, 
or altering the appearance.'' 21 U.S.C. 321(i). Dental floss is 
considered a ``device'' under the FFDCA because it is ``an instrument, 
apparatus, implement, machine, contrivance, implant * * * intended to 
affect the structure or any function of the body of man * * *'' or, 
alternatively, is intended for use in the mitigation or prevention of 
disease. 21 U.S.C. 321(h). Products and materials that are not consumer 
products under the Commission's jurisdiction are not subject to section 
101(a) of the CPSIA, and testing of these products and materials are 
not required under section 102(a) of the CPSIA. Such cosmetics and 
devices would, instead, be subject to the requirements of the FFDCA.

5. Glues and Adhesives

    A number of commenters sought determinations for glues and 
adhesives. Certain glues are made entirely from natural materials, such 
as animal glue. Accordingly, animal glue has been added under new Sec.  
1500.91(d)(8). However, we did not receive specific data regarding 
specific formulations of individual glues and adhesives; therefore we 
cannot make determination regarding the entire category of glues and 
adhesives that may be available in the marketplace. However, we believe 
that in most instances, glues and adhesives will be inaccessible to 
children.
    The Commission has issued a final interpretative rule on 
inaccessible component parts (inaccessibility rule) which finds that a 
component part is not accessible if it is not physically exposed by 
reason of a sealed covering or casing and does not become physically 
exposed through reasonably foreseeable use and abuse of the product 
including swallowing, mouthing, breaking, or other children's 
activities and the aging of the product. (74 FR 39535 (August 7, 
2009)). In the inaccessibility rule, the Commission provided that 
accessibility probes specified for sharp points or edges at 16 CFR 
1500.48 through 1500.49 should be used to determine whether a lead-
containing component can be contacted by a child. In addition, the 
inaccessibility rule provides that the use and abuse tests specified in 
16 CFR 1500.50 through 1500.53 should be used to assess the 
accessibility of lead-component parts during normal and reasonably 
foreseeable use and abuse of a product by a child. However, paint, 
coatings or electroplating may not be considered a barrier that would 
render lead in the substrate to be inaccessible to a child.
    Most glues and adhesive are used to affix decorations and 
ornamentation to products or to secure sections of fabric, leather, 
wood, paper and other materials. In most instances, the glue or 
adhesive is usually not physically exposed because the materials 
covering the glue or adhesive serve as barrier to the underlying glue 
or adhesive. For instance, a children's book is bound with adhesives, 
but the adhesive is not accessible because the spine is covered with 
paper, cloth, leather, or other materials, and would not become 
physically exposed through reasonably foreseeable use and abuse of the 
product. As set forth in the inaccessibility rule, manufacturers of 
children's products should use the Commission accessibility probes 
specified for sharp points or edges at 16 CFR 1500.48 through 1500.49, 
and the use and abuse tests specified in 16 CFR 1500.50 through 1500.53 
to determine whether glue or adhesives, or other components, would be 
accessible to children.

6. Composite Wood Products

    Several commenters stated that wood is not expected to contain lead 
while other commenters asked us to expand the determination to include 
related products, such as composite wood constructed of wood, 
adhesives, and other materials.
    The commenters did not provide sufficient test data or other 
information to enable us to assess whether the lead content of 
manufactured wood products that contain various non-wood materials 
would fall under the lead content limits prescribed by the CPSIA. A 
request for a Commission determination for materials that fall under 
the lead content limits of the CPSIA must provide data and other 
information requested under the procedures rule. Accordingly, although 
the final rule does not include composite wood products, a request for 
a specific materials determination may be submitted to the Commission, 
consistent with those requirements.

7. Certain Finishes

    Several commenters requested that water based paints, acrylic 
paints, water based clear finishes, varnishes, lacquers, and milk paint 
be determined to comply with the lead content limits.
    We decline to revise the rule as suggested by the comments. The 
Commission has long-standing regulations on paint and similar surface 
coatings at 16 CFR part 1303. Section 101(f) of the CPSIA imposed an 
even stricter lead limit for paint and similar surface coatings from 
600 ppm total lead by weight to 90 ppm total lead by weight as of 
August 14, 2009. Because of the well-documented danger to children from 
contact with lead-containing paints and similar surface coatings and 
past instances of children's products bearing lead-containing paints or 
coatings despite regulations prohibiting the practice, such materials 
must be tested to show their compliance with the regulations, and we 
have revised proposed Sec.  1500.91(a) to include the following: 
``Materials used in products intended primarily for children 12 and 
younger that are treated or coated with paint or similar surface-
coating materials that are subject to 16 CFR part 1303, must comply 
with the requirements for lead paint under section 14(a) of the 
Consumer Product Safety Act (CPSA), as amended by section 102(a) of the 
CPSIA.''

8. Other Metals Including Titanium, Aluminum, Pewter, Copper

    Some commenters requested that certain other metals, including 
stainless steel, titanium, aluminum, pewter and copper be added to the 
list of determinations.
    We agree, in part, with the commenters that stainless steel (with 
the exception of one stainless steel alloy) and titanium should be 
added to

[[Page 43035]]

the list of determinations. [Ref. 6]. Stainless steel is a generic name 
for corrosion-resistant steel alloys. Typically, the manufacturing 
process for stainless steel uses recycled scrap as well as ``virgin'' 
(newly refined) steel, yet the manufacturing process heats the steel to 
temperatures high enough to vaporize any lead and lead oxide present. 
Once the steel melts, the mix is subjected to a vacuum, and the lead/
lead oxide gases are drawn off for condensation and recycling. 
Consequently, the manufacture of stainless steels results in alloys 
with lead concentrations less than 100 ppm.
    However, we found that one stainless steel alloy, designated as 
303Pb, does contain lead. The concentration of lead in 303Pb stainless 
steel is between 0.12% and 0.30% (1200 to 3000 ppm). The Unified 
Numbering System designation for 303Pb steel is S30360. Thus, 303Pb 
stainless steel is excluded from any determination for stainless steel. 
The Commission has revised proposed Sec.  1500.91(d)(1) (now renumbered 
as Sec.  1500.91(e)(1)) to add ``other stainless steel within the 
designations of Unified Numbering System, UNS S13800-S66286, not 
including the stainless steel designated as 303Pb (UNS S30360).''
    Titanium (both [alpha]- and [beta]-phase) uses elements such as 
aluminum, gallium, oxygen, nitrogen, molybdenum, vanadium, tungsten, 
tantalum, and silicon as alloying materials. Lead is considered an 
undesired impurity and is not found in titanium alloys. In all of the 
titanium alloys examined, we did not find an instance where lead was a 
constituent. Consequently, the Commission has revised proposed Sec.  
1500.91(d)(2) (now renumbered as Sec.  1500.91(e)(2)) to add 
``titanium'' to the list of determinations on precious metals.
    As for other metals and alloys, including aluminum, copper and 
pewter, such metals and alloys may contain significant amounts of lead, 
and we cannot verify that the specific products containing such metals 
or alloys comply with the lead content limits without testing. (See 
e.g., American Society for Metals: Metals Handbook, Properties and 
Selection: Nonferrous Alloys and Pure Metals, 9th ed., v.2 (1979).) 
Accordingly, these other metals and alloys continue to be subject to 
the testing and certification requirements of section 102 of the CPSIA.

9. Other Minerals and Items Found in the Earth

    Several commenters stated that, in addition to certain precious and 
semiprecious gems, other minerals and items found in the earth, such as 
rocks or fossils, should be determined to contain lead below the lead 
content limits.
    As with the precious gemstones and certain semi-precious stones 
that the Commission determines do not contain lead at levels that 
exceed the CPSIA lead content limits, other rocks and stones may comply 
with lead limits provided that they are not based on lead or lead 
compounds and are not associated in nature with any mineral that is 
based on lead or lead compounds. [Ref. 4]. In general, we agree that 
most minerals do not contain lead.
    However, some minerals are known to contain lead or are associated 
in nature with minerals than contain lead. We have previously 
identified minerals that can contain lead, such as aragonite, 
bayldonite, boleite, cerussite, croroite, linarite, mimetite, 
phosgenite, vanadinite, and wufenite. We have also identified galena, 
and will add this mineral to the list of lead-containing minerals under 
section 1500.91(d)(2). Accordingly, these minerals are specifically 
excluded from the determinations regarding minerals generally, and 
would require testing if they are used in any children's products to 
assess whether they are under the lead content limits.

10. Ceramic Glaze and Clay

    A few commenters claimed that ceramic glazes and clays comply with 
lead limits.
    We are aware that some products or materials used in ceramics 
production do not contain lead or use lead-free glazes, but others are 
known to contain lead at levels that exceed the CPSIA limits for lead 
content. Lead in ceramic ware typically comes from the varnish or glaze 
applied to give a shiny finish to the product. In addition, certain 
colorants used in decoration may contain lead pigments. Without the 
required testing of ceramic glazes and other materials, compliance with 
the lead content limits of the CPSIA cannot be verified for the myriad 
of products that are available. Moreover, in the Joint Conference 
Report, H.R. Rep. No. 110-787, the conferees stated under the section 
titled Special Issues that they ``believe the Commission should take 
appropriate action with respect to lead included in any ceramic product 
within its jurisdiction.'' Conference Report on H.R. 4040, Consumer 
Product Safety Improvement Act of 2008, 154 Cong. Rec. H7214 (daily ed. 
July 29, 2008). Accordingly, for children's ceramic ware, until the 
Commission receives detailed information and test data regarding lead 
in ceramic ware, the Commission will continue to require the testing 
and certification requirements under section 102 of the CPSIA.

11. Glass, Crystals, and Rhinestones

    Several commenters listed glass, glass beads, rhinestones, leaded 
glass crystals, and porcelain enamel as items that should be exempted 
from compliance with the CPSIA requirements for lead content or 
testing.
    While not all glass or glass products, crystals, or rhinestones 
contain lead at levels that exceed the CPSIA lead limits, in the 
absence of tests or other data on these products, we cannot verify that 
such products meet the CPSIA's lead content limits. Further, many 
leaded glass crystals and other glass-based products contain lead at 
levels exceeding the statutory limits and, therefore, cannot be 
included in a determination that they do not and would not contain 
lead. We also note that, on July 17, 2009, the Commission voted 2-1 to 
deny a request to exclude crystal and glass beads, including 
rhinestones and cubic zirconium, from the lead content limits. The 
Commissioners' statements accompanying that decision can be found at: 
http://www.cpsc.gov/about/cpsia/sect101.html#statements.

12. Pencils, Crayons, Other Materials Regulated as Art Materials

    Some commenters requested that certain art materials be determined 
to not contain lead at levels that exceed the CPSIA lead limits.
    The CPSIA's requirements for lead content are in addition to other 
statutory and regulatory requirements for children's art materials. 
Compliance under the Labeling of Hazardous Art Materials Act (LHAMA) 
(15 U.S.C. 1277) requires the submission of art material product 
formulations to a toxicologist for review to assess chronic adverse 
health effects through customary or reasonably foreseeable use. If the 
toxicologist determines that the art material has this potential, the 
producer or repackager must use cautionary labeling on the product in 
accordance with the requirements set forth at 16 CFR 1400.14(b)(8), and 
section 2(p) of the FHSA, 15 U.S.C. 1261(p). Any art material intended 
for children that is or contains a hazardous substance (by reason 
either of chronic or acute toxicity) would be a banned hazardous 
substance under section 2(q)(1)(A) of the FHSA, 15 U.S.C. 
1261(q)(1)(A). Art supplies that are intended primarily for use by 
children must also comply with the lead content

[[Page 43036]]

limits under section 101(a) of the CPSIA. Accordingly, without 
receiving more information and data regarding the lead content of 
specific art materials intended primarily for children, we are unable 
to make any determinations in this proceeding.

13. Fabrics, Dyes and Similar Materials

    Numerous commenters claimed that many fabrics, yarns, batting, 
fill, and similar materials (such as ribbon), and related materials 
(such as elastic), including those that are dyed or similarly 
processed, do not contain lead. In addition, some commenters requested 
a determination that fabric dyes comply with the lead content limits. 
The commenters provided data and other information to support their 
claims. Additionally, during a public meeting held on January 22, 2009, 
industry representatives, test laboratories, and stakeholders met with 
CPSC staff and presented materials and test data on lead levels in 
textile and apparel products. Several hundred test reports and analyses 
were submitted. The tests analyzed lead levels in various textile and 
apparel products, including a range of daywear, sleepwear, and 
outerwear garments. Tests for lead were also conducted on the many 
functional and decorative components used on apparel items. These items 
include adornments (rhinestones and beads), closures and findings 
(buttons, snaps, and zippers), trims, and fasteners.
    Information on the dye industry was also submitted by the 
Ecological Association of Dye and Organic Pigment Manufacturers (ETAD). 
ETAD states that it represents about 80% of worldwide dye 
manufacturers. According to ETAD, 80% or more of dyes used in 
commercial processing are organic carbon compounds and do not contain 
lead. Dyes used for cotton, other cellulosics, and polyester, the most 
commonly used fibers for apparel, account for 70% of total dye 
consumption. According to ETAD, these fibers use specific dye classes 
(e.g., disperse, direct, reactive) that would not contain lead. ETAD 
also recommends that its member companies follow lead limits of 100 ppm 
using a sampling and testing procedure that ensures the recommended 
limits.
a. Textiles
    We reviewed the data pertaining to textile products intended for 
children and the general practices used in the textile industry and the 
modern production and coloration of textiles and apparel. [Refs. 1 and 
3]. We conclude that most textile products are manufactured using 
processes that do not introduce lead or result in an end product that 
would not exceed the CPSIA's lead limits. Modern textile and apparel 
production practices are recognized and well-characterized. With a few 
uncommon exceptions, modern production practices do not involve lead or 
lead-based chemicals.
    In general, textile materials and products do not contain lead and 
have not undergone any processing or treatment that imparts lead 
resulting in a total lead content that exceeds the CPSIA total lead 
limits. Accordingly, new Sec.  1500.91(d)(7) adds ``Textiles'' to the 
list of determinations. Additionally, with respect to fibers from 
natural sources, we find that natural fibers are natural materials and 
do not contain lead, whether they are dyed or undyed. [Ref. 3]. 
Examples of plant based fibers, from the seed, stem, or leaves of 
plants, include, but are not limited to, cotton, kapok, flax, linen, 
jute, ramie, hemp, kenaf, bamboo, coir, and sisal. Animal fibers, or 
natural protein fibers, include but are not limited to silk, wool 
(sheep), and hair fibers from alpaca, llama, goat (mohair, cashmere), 
rabbit (angora), camel, horse, yak, vicuna, qiviut, and guanaco. The 
final rule thus adds these natural fibers to Sec.  1500.91(d)(7)(a) 
(formerly proposed Sec.  1500.91(c)(5)).
    We also reviewed information pertaining to fibers that are not 
obtained from natural sources and are classified as manufactured or 
man-made. [Ref. 3]. Manufactured fibers are created by technology and 
are classified as regenerated, inorganic, or synthetic. Regenerated 
fibers are made from natural materials that are reformed into usable 
fibers. These fibers include, but are not limited to, rayon, azlon, 
lyocell, acetate, triacetate, and rubber. Synthetic fibers are polymers 
created through a chemical process and include, but are not limited to, 
polyester, olefin, nylon, acrylic, modacrylic, aramid, and spandex. The 
information we have indicates that manufactured fibers are produced in 
controlled environments by processes that do not use lead or 
incorporate lead at any time during their production, whether they are 
dyed or undyed. Consequently, we have added these manufactured fibers 
as a new Sec.  1500.91(d)(7)(b); specifically, the new provision refers 
to ``Manufactured fibers (dyed or undyed) including, but not limited 
to, rayon, azlon, lyocell, acetate, triacetate, rubber, polyester, 
olefin, nylon, acrylic, modacrylic, aramid, spandex.''
b. Dyes
    We also examined the dyes used on textiles. [Refs. 1 and 3]. Dyes 
are organic chemicals that can be dissolved and made soluble in water 
or another carrier so they can penetrate into the fiber. Dyes can be 
used in solutions or as a paste for printing. Commercial dyes are 
classified by chemical composition or method of application. Many dyes 
are fiber specific. For example, disperse dyes are used for dyeing 
polyester, and direct dyes are used for cellulosic fibers. Dyes can be 
applied to textiles at the fiber, yarn, fabric, or finished product 
stage. Dye colorants are not lead based. Although not typical, some dye 
baths may contain lead. However, even if the dye bath contains lead, 
the colorant that is retained by the finished textile after the rinsing 
process would not contain lead above a non-detectable lead level.
    In contrast to dyes, pigments are either organic or inorganic. 
Pigments are insoluble in water, are applied to the surface of textile 
materials, and are held there by a resinous binder. Binders used with 
pigments for textiles are non-lead based. Processes that are lead-based 
are used for some industrial textiles that require a greater level of 
colorfastness or durability, but are not typically intended for apparel 
textiles. Although most pigments do not contain lead, there may be some 
lead based paints and pigments on non-textile materials that may be 
directly incorporated into textile products or added to the surface of 
textiles, such as decals, transfers, and screen printing. All such non-
textile components must be tested for lead content under section 102 of 
the CPSIA unless they are made entirely from materials that the 
Commission has determined would not contain lead in excess of the CPSIA 
lead limits. Since we are allowing the use of dyes and pigments on 
textile materials, we have revised proposed Sec.  1500.91(c) (now 
renumbered as Sec.  1500.91(d)) to remove ``or chemicals such as 
pigments, dyes, coatings, finishes or any other substance, nor 
undergone any processing.'' However, we have excluded from ``Textiles'' 
under new paragraph Sec.  1500.91(d)(7), any textiles that are ``after-
treatment applications, including screen prints, transfers, decals, or 
other prints.''
c. Leather
    Although leather is not made from fibers like most textiles, it may 
be used to produce apparel and coverings or may be used along with 
textile products. Leather begins as natural products, but they undergo 
processing (e.g., tanning) to convert the natural skin into a usable, 
durable product. Similar to most textile products, leather products are 
often colored with dyes or pigments during their processing. Many of 
the same dyes used in the textile industry also are used

[[Page 43037]]

for dyeing leather. According to information submitted by the Leather 
Industries of America, many processes used to process and finish 
leather do not use lead or lead-based chemicals.
    However, many leather products may be finished with pigment-based 
coatings, including some that are colored using lead-based pigments. 
[Refs. 1 and 3]. Currently, any children's leather product that has 
paint or a similar surface-coating material is subject to the lead 
paint ban at 16 CFR part 1303. Products that are finished with such 
coatings are subject to the testing and certification for lead paint 
under section 102 of the CPSIA. Section 1303.2 (Definitions) 
specifically provides that paint or other similar surface coating 
includes application on wood, stone, paper, leather, cloth, plastic or 
other surface. The treatment that could potentially impart lead onto 
leather is the application of leaded pigment onto the surface of the 
leather product. We deleted the term ``untreated'' before the word 
``leather'' from former Sec.  1500.91(c)(6) (now renumbered as Sec.  
1500.91(d)(8)) because, as discussed in part D.7 of this preamble, 
Sec.  1500.91(a) makes explicit that the determinations do not cover 
any material in a children's product that has paint or similar surface-
coating materials subject to 16 CFR part 1303. Such materials and 
products must comply with the testing and certification requirements 
for lead paint under section 102 of the CPSIA.
d. Other Comments
    Several commenters, including the Organic Trade Association, stated 
that certifications based on standards such as the Global Organic 
Textile Standard (GOTS) and Oeko-Tex[supreg] should be allowed in place 
of testing for compliance with the CPSIA lead content requirements.
    Because the Commission has determined that textiles fall under the 
lead content limits, the Commission will not require testing on 
textiles under section 102 of the CPSIA. However, even when a 
particular product or material has been relieved of the requirement to 
undergo testing and certification under section 102 of the CPSIA, 
manufacturers and importers are responsible for verifying that the 
material or product has not been altered or modified, or experienced 
any change in the processing, facility or supplier conditions that 
could impart lead into the material or product and ensure that the 
material or product meets the statutory lead levels at all times. With 
respect to the GOTS and Oeko-Tex[supreg] standards, we believe that 
certifications from GOTS and Oeko-Tex[supreg] would serve to provide 
such verifications for textiles. Both GOTS and Oeko-Tex[supreg] 
standards limit lead content in certain textile products to no more 
than 100 ppm lead.

14. Book Components

    Several commenters, such as associations for the publishing, 
printing, and paper industries, and libraries, asked us to determine 
that ``ordinary books'' are within the CPSIA's lead content limits. The 
Association of American Publishers (AAP) defined ``ordinary books'' to 
mean paper-based, printed books that are designed or intended primarily 
for 12 years and younger. AAP states that it does not intend the term 
to include so-called ``novelty'' products such as, for example, 
plastic-based bath toys or teething products that are made to resemble 
books in shape and form, or books that have plastic, metal or 
electronic parts that are not part of the binding and with which 
children may be expected to interact. According to the commenters, 
ordinary books generally consist of papers, inks, coatings, adhesives, 
and bindings. We held three public meetings with representatives of 
these industries on January 22, 2009, June 9, 2009, and August 11, 
2009, in Bethesda, Maryland.
    Under section 101(a) of the CPSIA, the Commission is required to 
evaluate the lead content limit for any part of a product. Accordingly, 
we must assess whether each part of a children's book would contain 
lead over the lead content limits. Therefore, we reviewed comments, 
data, and other information regarding papers, inks, coatings, 
adhesives, and bindings to assess whether those components could 
contain lead over the lead content limits.
a. Paper
    Several commenters stated that paper is derived from natural wood, 
which inherently has a de minimis level of total lead content, and that 
the primary components in the production of paper are wood fiber and 
water. They stated that lead-based chemicals are not introduced in the 
major phases of the paper manufacturing process (i.e., wood 
preparation/pulping; bleaching/refining; running of the paper machine; 
and finishing processes, including coating).
    After review of the test data and other information submitted by 
the commenters, we have determined that paper and similar cellulosic 
materials do not contain lead in excess of the CPSIA's lead content 
limits. [Refs. 1 and 5]. Paper products include paper, paperboard, 
linerboard and medium, and pulp. Paper is predominantly made from wood, 
but also may be made with other cellulosic fibers. For tinting and 
coloring of fibers, dyes are most commonly used. Dyes, especially basic 
dyes and direct dyes, are relatively inexpensive and widely available 
and used in easily processed forms which are highly substantive to 
fiber and produce a uniform color or shade and which can be varied 
easily to achieve whatever shades are needed.
    Pigments, particularly inorganic pigments, are comparatively 
expensive and difficult to use due to their density. Complex chemistry 
must be added to get the pigments to retain the pigments with the 
fibers and not have them drain out. The comparative expense and 
difficulty involved in the use of inorganic pigments for coloration 
limits their use to highly-specialized grades of paper, such as for 
laminate countertop and flooring applications where the decorative 
layer must be lightfast, durable, and be able to withstand the heat and 
chemical conditions of the resin-impregnation stage to convert layers 
of paper into a countertop, such as Formica[supreg]. Such specialty 
papers are not expected to be used for ordinary printing and writing 
purposes. As with the fibers and textiles, paper and similar cellulosic 
materials, including the dyes and treatments used to make them, are not 
expected to contain lead above the CPSIA lead limits. Accordingly, we 
have added paper and similar materials made from wood or other 
cellulosic fiber, including, but not limited to, paperboard, 
linerboard, and medium to a new Sec.  1500.91(d)(5).
b. Printing Inks and Coatings
    With respect to inks, the commenters noted that, in theory, lead 
pigments can be used in any printing process; however, in practice, 
lead has been eliminated from all but a few limited applications such 
as outdoor signage, labels used in harsh environments, or other 
applications where the product's ability to withstand the weather is a 
critical factor. The commenters stated that, as a practical matter, 
lead-based or lead-containing inks are not used in modern printing 
processes. They explained that the regulations promulgated under the 
Resource Conservation and Recovery Act of 1976 (RCRA) (40 CFR part 
261.24) require that any waste, include printing ink, which contains 
lead in an amount exceeding five (5) ppm must be treated as hazardous 
waste. They also pointed to regulations promulgated under the 
Occupational Safety and Health Act (OSHA) (29 CFR 1910.1025) which 
requires workplaces in which lead is

[[Page 43038]]

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

[[Page 43039]]

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

[[Page 43040]]

all older children's books fall under the lead content limits.
    For older used children's books that are sold, many of these books 
may be collector's items that are sold to adults. Such books would not 
be considered to be intended primarily for children, and accordingly, 
may continue to be sold to adults. For older used children's books that 
are lent out, ALA has requested additional guidance regarding the 
treatment of these products. Accordingly, the Commission intends to 
issue a separate Statement of Policy addressing the treatment of older 
children's books.

15. Issues Related to Component Part Testing

a. Material Safety Data Sheet (MSDS)
    Some commenters indicated that the materials they use should not 
require testing because the material safety data sheets (MSDS) already 
show that the materials do not contain lead.
    As the Commission stated in the procedures rule, material safety 
data sheets are insufficient for purposes of demonstrating compliance 
with the lead limits under the CPSIA (74 FR at 10478). Since 
regulations concerning MSDS require reporting only for chemicals with 
content levels that exceed 1000 ppm, the MSDS sheets cannot be used to 
show that a product complies with the lead limits of the CPSIA, which 
are 600 ppm for products sold after February 10, 2009, 300 ppm for 
products sold after August 14, 2009, and 100 ppm for products sold 
after August 14, 2011 (if deemed to be technologically feasible).
b. Metal, Plastic and Painted Components
    Many commenters requested a testing exemption for certain metal and 
plastic items, such as buttons, zippers, snaps, grommets, eyelets, head 
bands, hair combs and clips, and barrettes. Other commenters mentioned 
products such as plastic hangers, dolls and doll accessories (such as 
shoes and eyeglasses), pipe-stem cleaners, brass or other metal bells, 
beading wire, and certain construction materials such as Plexiglas and 
aluminum screening. Some commenters listed fasteners, such as nails, 
screws, or plastic fasteners, as items that should be exempted from 
compliance with CPSIA requirements. Most commenters did not provide 
test data or other information about the lead content of these types of 
products. However, some commenters from the apparel industry 
acknowledged that lead has been found sometimes in apparel accessories, 
such as zippers, buttons, snaps, and grommets.
    In general, plastic, metal, and painted materials and products (for 
which determinations have not been made) have been found, in certain 
instances, to contain lead at levels that exceed the CPSIA lead limits. 
Data provided in response to the proposed rule and at the CPSC public 
meeting with members of the textile industry showed that some items, 
such as zippers, buttons, and other applied decorations, currently 
contain lead levels that exceed the CPSIA's lead content levels. In 
addition, based on the Commission's past experience with other 
children's products that have been found to contain lead, the 
Commission cannot make a determination that any component parts made 
out of plastic or metal (with the exception of metal determinations 
made in this rule) are below the lead content limits. Accordingly, 
these products and materials continue to be subject to the lead content 
limits of section 101(a) of the CPSIA, as well the testing and 
certification requirements of section 102 of the CPSIA.
    The Commission is aware that there are many questions regarding 
component part testing and certification for lead content given that 
any children's product may be made with a number of materials and 
component parts. The questions regarding testing and certification are 
significant because not all component parts may need to be tested if 
they fall under the scope of the exclusions approved by the Commission. 
For example, component parts would not need to be tested if they: (1) 
Are inaccessible, as set forth under the Commission's regulations at 16 
CFR 1500.87; (2) are or contain an electronic device exempt under the 
Commission's regulations at 16 CFR 1500.88; or (3) are made of material 
determined by the Commission to fall under lead content limits in this 
rule (to be codified as 16 CFR 1500.91(a)-(e)(2). However, all other 
component parts will need to tested and certified under section 102 of 
the CPSIA. The Commission intends to address component part testing and 
the establishment of protocols and standards for ensuring that 
children's products are tested for compliance with applicable 
children's products safety rules, as well as products that fall within 
an exemption, in an upcoming rulemaking.

E. Impact on Small Businesses

    A few commenters stated that the new rule would have a significant 
impact on small businesses. These commenters stated that the CPSIA 
would have devastating economic consequences for small businesses that 
cannot afford to test their products.
    These commenters have misinterpreted the Regulatory Flexibility Act 
(RFA) section of the proposed rule. That section did not address the 
impact of the CPSIA on small businesses; that section addressed what 
impact the proposed rule on the determinations would have on small 
businesses. The Commission does not have the authority to change the 
CPSIA. However, under the general rulemaking authority vested to the 
Commission under section 3 of the CPSIA, the Commission has the 
authority to promulgate a rule to determine that certain products or 
materials would not exceed the lead content limits. When an agency 
issues a proposed rule, it must prepare an initial regulatory 
flexibility analysis describing the impact the proposed rule is 
expected to have on small entities. 5 U.S.C. 603. The RFA does not 
require a regulatory flexibility analysis if the head of the agency 
certifies that the rule will not have a significant effect on a 
substantial number of small entities.
    The Commission's Directorate for Economic Analysis prepared a 
preliminary assessment of the impact of relieving certain materials or 
products from the testing requirements of section 102 of the CPSIA if 
they were found to be inherently under the lead content limits 
prescribed. [Ref. 7]. The number of small businesses that will be 
directly affected by the rule is unknown, but could be considerable. 
However, the final rule will not result in any increase in the costs of 
production for any firm. Its only effect on businesses, including small 
businesses, will be to reduce the costs that would have been associated 
with testing the materials under section 102 of the CPSIA. Based on the 
foregoing assessment, the Commission certifies that the rule would not 
have significant impact on a substantial number of small entities.

F. Environmental Considerations

    Generally, CPSC rules are considered to ``have little or no 
potential for affecting the human environment,'' and environmental 
assessments are not usually prepared for these rules (see 16 CFR 
1021.5(c)(1)). The determinations rule is not expected to have an 
adverse impact on the environment, thus, the Commission concludes that 
no environment assessment or environmental impact statement is required 
in this proceeding.

[[Page 43041]]

G. Executive Orders

    According to Executive Order 12988 (February 5, 1996), agencies 
must state in clear language the preemptive effect, if any, of new 
regulations. The preemptive effect of regulations such as this proposal 
is stated in section 18 of the FHSA. 15 U.S.C. 1261n.

H. Effective Date

    The Administrative Procedure Act requires that a substantive rule 
must be published not less than 30 days before its effective date, 
unless the rule relieves a restriction. 5 U.S.C. 553(d)(1). Because the 
final rule provides relief from existing testing requirements under the 
CPSIA, the effective date is August 26, 2009.

I. References

    The following references are available from the Commission's Office 
of the Secretary, Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814; telephone 301-504-7923; or e-mail: <a href="/cdn-cgi/l/email-protection#d4b7a4a7b7f9bba794b7a4a7b7fab3bba2"><span class="__cf_email__" data-cfemail="d1b2a1a2b2fcbea291b2a1a2b2ffb6bea7">[email protected]</span></a> or from the Commission's Web site (http://www.cpsc.gov/library/foia/foia09/brief/leadfinalrule.pdf).

1. Memorandum from Kristina M. Hatlelid and Robert J. Howell, 
``Consumer Product Safety Improvement Act of 2008 (CPSIA)--
Determination of Lead Content for Certain Products and Materials,'' 
August 6, 2009.
2. Memorandum from Kristina M. Hatlelid to Mary Ann Danello, 
``Response to Public Comments: Determinations,'' August 6, 2009.
3. Memorandum from Allyson Tenney to Kristina Hatlelid, ``Textiles 
and Apparel Subject to the CPSIA,'' June 5, 2009.
4. Memorandum from Mark F. Gill to Kristina M. Hatlelid, ``Results 
of Research on Lead Content in Slate,'' July 22, 2009.
5. Memorandum from Joel Recht to Kristina Hatlelid, ``Lead in 
Paper,'' July 15, 2009.
6. Memorandum from Randy Butturini to Kristina M. Hatlelid, ``Lead 
in Stainless Steel and Titanium Alloys,'' June 3, 2009.
7. Memorandum from Robert Franklin to Kristina Hatlelid, ``Final 
regulatory analysis of a rule making determinations that certain 
materials or products do not have lead contents that exceed the 
limits established in section 101(a) of the CPSIA,'' July 17, 2009.

List of Subjects in 16 CFR Part 1500

    Consumer protection, Hazardous materials, Hazardous substances, 
Imports, Infants and children, Labeling, Law enforcement, and Toys.

J. Conclusion

0
For the reasons stated above, the Commission amends title 16 of the 
Code of Federal Regulations as follows:

PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND 
ENFORCEMENT REGULATIONS

0
1. The authority for part 1500 continues to read as follows:

    Authority: 15 U.S.C. 1261-1278, 122 Stat. 3016.


0
2. Add a new Sec.  1500.91 to read as follows:


Sec.  1500.91  Determinations regarding lead content for certain 
materials or products under section 101 of the Consumer Product Safety 
Improvement Act.

    (a) The Consumer Product Safety Improvement Act provides for 
specific lead limits in children's products. Section 101(a) of the 
CPSIA 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, products designed or intended primarily 
for children 12 and younger cannot contain more than 300 ppm of lead. 
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 or electroplating may not be 
considered a barrier that would make the lead content of a product 
inaccessible to a child. Materials used in products intended primarily 
for children 12 and younger that are treated or coated with paint or 
similar surface-coating materials that are subject to 16 CFR part 1303, 
must comply with the requirements for lead paint under section 14(a) of 
the Consumer Product Safety Act (CPSA), as amended by section 102(a) of 
the CPSIA.
    (b) Section 3 of the CPSIA grants the Commission general rulemaking 
authority to issue regulations, as necessary, either on its own 
initiative or upon the request of any interested person, to make a 
determination that a material or product does not exceed the lead 
limits as provided under paragraph (a) of this section.
    (c) A determination by the Commission under paragraph (b) of this 
section that a material or product does not contain lead levels that 
exceed 600 ppm, 300 ppm, or 100 ppm, as applicable, does not relieve 
the material or product from complying with the applicable lead limit 
as provided under paragraph (a) of this section if the product or 
material is changed or altered so that it exceeds the lead content 
limits.
    (d) The following materials do not exceed the lead content limits 
under section 101(a) of the CPSIA provided that these materials have 
neither been treated or adulterated with the addition of materials that 
could result in the addition of lead into the product or material:
    (1) Precious gemstones: diamond, ruby, sapphire, emerald.
    (2) Semiprecious gemstones and other minerals, provided that the 
mineral or material is not based on lead or lead compounds and is not 
associated in nature with any mineral based on lead or lead compounds 
(excluding any mineral that is based on lead or lead compounds 
including, but not limited to, the following: aragonite, bayldonite, 
boleite, cerussite, crocoite, galena, linarite, mimetite, phosgenite, 
vanadinite, and wulfenite).
    (3) Natural or cultured pearls.
    (4) Wood.
    (5) Paper and similar materials made from wood or other cellulosic 
fiber, including, but not limited to, paperboard, linerboard and 
medium, and coatings on such paper which become part of the substrate.
    (6) CMYK process printing inks (excluding spot colors, other inks 
that are not used in CMYK process, inks that do not become part of the 
substrate under 16 CFR part 1303, and inks used in after-treatment 
applications, including screen prints, transfers, decals, or other 
prints).
    (7) Textiles (excluding after-treatment applications, including 
screen prints, transfers, decals, or other prints) consisting of:
    (i) Natural fibers (dyed or undyed) including, but not limited to, 
cotton, kapok, flax, linen, jute, ramie, hemp, kenaf, bamboo, coir, 
sisal, silk, wool (sheep), alpaca, llama, goat (mohair, cashmere), 
rabbit (angora), camel, horse, yak, vicuna, qiviut, guanaco;
    (ii) Manufactured fibers (dyed or undyed) including, but not 
limited to, rayon, azlon, lyocell, acetate, triacetate, rubber, 
polyester, olefin, nylon, acrylic, modacrylic, aramid, spandex.
    (8) Other plant-derived and animal-derived materials including, but 
not limited to, animal glue, bee's wax, seeds, nut shells, flowers, 
bone, sea shell, coral, amber, feathers, fur, leather.
    (e) The following metals and alloys do not exceed the lead content 
limits under section 101(a) of the CPSIA, provided that no lead or 
lead-containing metal is intentionally added but does not include the 
non-steel or non-precious metal components of a product, such as solder 
or base metals in electroplate, clad, or fill applications:
    (1) Surgical steel and other stainless steel within the 
designations of Unified Numbering System, UNS S13800-

[[Page 43042]]

S66286, not including the stainless steel designated as 303Pb (UNS 
S30360).
    (2) Precious metals: Gold (at least 10 karat); sterling silver (at 
least 925/1000); platinum; palladium; rhodium; osmium; iridium; 
ruthenium, titanium.

    Dated: August 19, 2009.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. E9-20589 Filed 8-25-09; 8:45 am]
BILLING CODE 6335-01-P


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