Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 43031 

1Currently, 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. 

miles southwest of the LOM/NDB. This Class 

E airspace area is effective during the specific 

dates and times established in advance by a 

Notice to Airmen. The effective date and time 

will thereafter be continuously published in 

the Airport/Facility Directory. 

* * * * * 

Issued in Seattle, Washington, on August 

14, 2009. 

H. Steve Karnes, 

Team Manager, Operations Support Group, 

Western Service Center. 

[FR Doc. E9–20282 Filed 8–25–09; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 khatlelid@cpsc.gov. 

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. 

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: 

• Precious gemstones (diamond, ruby, 

sapphire, emerald); 

• 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); 

• Natural or cultured pearls; 

• Wood; 

• Natural fibers (such as cotton, silk, 

wool, hemp, flax, linen); and 

• 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 

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43032 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

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 §§ 1500.91(c) and (d) 

(renumbered as §§ 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 § 1500.91(c) 

(renumbered as § 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 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 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 

§ 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 surfacecoating 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 § 1500.91(d)(8). Specifically, the 

new provision covers ‘‘other plantderived 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 

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43034 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

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 § 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 § 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 leadcontaining 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 leadcomponent 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 leadcontaining 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 § 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 surfacecoating 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 

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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 § 1500.91(d)(1) (now 

renumbered as § 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 a- and b-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 

§ 1500.91(d)(2) (now renumbered as 

§ 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 

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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 § 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 § 1500.91(d)(7)(a) 

(formerly proposed § 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 

§ 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 § 1500.91(c) (now 

renumbered as § 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 § 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 

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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 § 1500.91(c)(6) (now 

renumbered as § 1500.91(d)(8)) because, 

as discussed in part D.7 of this 

preamble, § 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® 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®

standards, we believe that certifications 

from GOTS and Oeko-Tex® would serve 

to provide such verifications for textiles. 

Both GOTS and Oeko-Tex® 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®. 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 § 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 

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43038 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

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 leadbased 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. Leadbased 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 § 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 § 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, waterbased ink, plastisols, and the solventbased 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 

§ 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 

§ 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 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 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 

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43040 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

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. 

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Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 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: cpsc-os@cpsc.gov 

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 

■ 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 

■ 1. The authority for part 1500 

continues to read as follows: 

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

3016. 

■ 2. Add a new § 1500.91 to read as 

follows: 

§ 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 animalderived 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– 

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43042 Federal Register / Vol. 74, No. 164 / Wednesday, August 26, 2009 / Rules and Regulations 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2009–N–0381] 

Advisory Committee; Tobacco 

Products Scientific Advisory 

Committee; Establishment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Establishment of the Tobacco Products 

Scientific Advisory Committee. These 

actions are needed to implement the 

Federal Food, Drug, and Cosmetic Act, 

as amended by the Family Smoking 

Prevention and Tobacco Control Act. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing two 

separate documents requesting 

nominations for voting and non-voting 

membership on this committee. This 

document also amends the agency’s 

regulations to add the Tobacco Products 

Scientific Advisory Committee (the 

committee) to the agency’s list of 

standing advisory committees. 

DATES: This rule is effective August 26, 

2009. The committee is being 

established and this charter will remain 

in effect until amended or terminated by 

the Commissioner of Food and Drugs 

(the Commissioner). 

FOR FURTHER INFORMATION CONTACT: Erik 

P. Mettler, Office of Policy, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 1, Rm. 4324, 

Silver Spring, MD 20993–0002, 301– 

796–4711, FAX: 301–847–3541, e-mail: 

erik.mettler@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

committee was established under 21 

U.S.C. 387q, as added by section 917 of 

the Family Smoking Prevention and 

Tobacco Control Act (Public Law 111– 

31). The committee is also governed by 

part 14 (21 CFR part 14), Public Law 92– 

463 (5 U.S.C. app.), and the Federal 

Advisory Committee Act, which sets 

forth standards for the formation and 

use of advisory committees. The 

committee advises the Commissioner or 

designee in discharging responsibilities 

as they relate to the regulation of 

tobacco products. 

The committee reviews and evaluates 

safety, dependence, and health issues 

relating to tobacco products and 

provides appropriate advice, 

information, and recommendations to 

the Commissioner. 

Specifically, the committee will 

submit reports and recommendations on 

tobacco-related topics, including the 

following: 

• The impact of the use of menthol in 

cigarettes on the public health, 

including such use among children, 

African Americans, Hispanics and other 

racial and ethnic minorities; 

• The nature and impact of the use of 

dissolvable tobacco products on the 

public health, including such use on 

children; 

• The effects of the alteration of 

nicotine yields from tobacco products 

and whether there is a threshold level 

below which nicotine yields do not 

product dependence on the tobacco 

product involved; and 

• Any application submitted by a 

manufacturer for a modified risk 

tobacco product. 

The committee may provide 

recommendations to the Secretary of 

Health and Human Services regarding 

any regulations to be issued under the 

Federal Food, Drug, and Cosmetic Act 

and may review any applications for 

new tobacco products or petitions for 

exemption under section 906(e) of the 

Family Smoking Prevention and 

Tobacco Control Act. The committee 

may consider and provide 

recommendations on any other matter 

as provided in the Family Smoking 

Prevention and Tobacco Control Act. 

The committee shall consist of 12 

members including the Chair. Members 

and the Chair are selected by the 

Commissioner or designee from among 

individuals knowledgeable in the fields 

of medicine, medical ethics, science, or 

technology involving the manufacture, 

evaluation, or use of tobacco products. 

Members will be invited to serve for 

overlapping terms of up to 4 years. 

Almost all non-Federal members of this 

committee serve as Special Government 

Employees. The committee shall 

include nine technically qualified 

voting members, selected by the 

Commissioner or designee. The nine 

voting members shall be physicians, 

dentists, scientists, or health care 

professionals practicing in the area of 

oncology, pulmonology, cardiology, 

toxicology, pharmacology, addiction, or 

any other relevant specialty. One 

member shall be an officer or employee 

of a State or local government or of the 

Federal Government. The final voting 

member shall be a representative of the 

general public. In addition to the voting 

members, the committee shall include 

three nonvoting members who are 

identified with industry interests. These 

members shall include one 

representative of the tobacco 

manufacturing industry, one 

representative of the interests of tobacco 

growers, and one representative of the 

interests of the small business tobacco 

manufacturing industry. This final 

position can be filled on a rotating, 

sequential basis by representatives of 

different small business tobacco 

manufacturers based on areas of 

expertise relevant to the topics being 

considered by the committee. 

The Commissioner or designee shall 

designate one of the voting members of 

the committee to serve as chairperson. 

As added by section 917 of the Family 

Smoking Prevention and Tobacco 

Control Act, 21 U.S.C. 387q(d)(3) 

provides that section 14 of the Federal 

Advisory Committee Act does not apply 

to this committee. 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely amends 

the information in § 14.100 to reflect the 

establishment of the committee. 

Therefore the agency is amending 

§ 14.100(a) as set forth in the regulatory 

text of this document. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended to read as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155. 

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