3154 Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 

1The Commission voted 5–0 to publish this final 

rule, with changes, in the Federal Register. 

Chairman Inez M. Tenenbaum, and Commissioners 

Thomas H. Moore, Nancy Nord, Robert Adler, and 

Anne Northup voted to publish the notice with 

changes. Commissioner Northup issued a statement, 

and the statement can be found at http:// 

www.cpsc.gov/PR/northup01062010devices.pdf. 

(d) * * * 

(2) * * * 

(v) § 135.1—Applicability 

* * * * * 

■ 8. Revise paragraphs (a)(2) and (e)(2) 

of § 120.117 to read as follows: 

§ 120.117 Implementing a drug testing 

program. 

(a) * * * 

If you are ... You must ... 

* * * * * * * 

(2) An operator as defined in § 91.147 of this chapter ............................ Register with the FAA by contacting the Flight Standards District Office 

nearest to your principal place of business. 

* * * * * * * 

* * * * * 

(e) * * * 

(2) Send this information in the form 

and manner prescribed by the 

Administrator, in duplicate to the 

appropriate address below: 

(i) For § 91.147 operators: The Flight 

Standards District Office nearest to your 

principal place of business. 

(ii) For all others: The Federal 

Aviation Administration, Office of 

Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue, SW., Washington, DC 20591. 

* * * * * 

■ 9. Revise paragraph (b) of § 120.119 to 

read as follows: 

§ 120.119 Annual reports. 

* * * * * 

(b) As an employer, you must use the 

Management Information System (MIS) 

form and instructions as required by 49 

CFR part 40 (at 49 CFR 40.26 and 

appendix H to 49 CFR part 40). You may 

also use the electronic version of the 

MIS form provided by DOT. The 

Administrator may designate means 

(e.g., electronic program transmitted via 

the Internet) other than hard-copy, for 

MIS form submission. For information 

on where to submit MIS forms and for 

the electronic version of the form, see: 

http://www.faa.gov/about/office_org/

headquarters_offices/avs/offices/aam/

drug_alcohol. 

* * * * * 

■ 10. Add paragraph (b)(5) to § 120.211 

to read as follows: 

§ 120.211 Applicable Federal regulations. 

* * * * * 

(b) * * * 

(5) § 135.1—Applicability 

■ 11. Revise paragraph (e)(2) of 

§ 120.225 to read as follows: 

§ 120.225 How to implement an alcohol 

testing program. 

* * * * * 

(e) * * * 

(2) Send this information in the form 

and manner prescribed by the 

Administrator, in duplicate to the 

appropriate address below: 

(i) For § 91.147 operators: The Flight 

Standards District Office nearest to your 

principal place of business. 

(ii) For all others: The Federal 

Aviation Administration, Office of 

Aerospace Medicine, Drug Abatement 

Division (AAM–800), 800 Independence 

Avenue, SW., Washington, DC 20591. 

* * * * * 

PART 135—OPERATING 

REQUIREMENTS: COMMUTER AND 

ON DEMAND OPERATIONS AND 

RULES GOVERNING PERSONS ON 

BOARD SUCH AIRCRAFT 

■ 12. The authority citation for part 135 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 41706, 40113, 

44701–44702, 44705, 44709, 44711–44713, 

44715–44717, 44722, 45101–45105. 

■ 13. Revise paragraph (a)(5) of § 135.1 

to read as follows: 

§ 135.1 Applicability. 

(a) * * * 

(5) Nonstop Commercial Air Tour 

flights conducted for compensation or 

hire in accordance with § 119.1(e)(2) of 

this chapter that begin and end at the 

same airport and are conducted within 

a 25-statute-mile radius of that airport; 

provided further that these operations 

must comply only with the drug and 

alcohol testing requirements in 

§§ 120.31, 120.33, 120.35, 120.37, and 

120.39 of this chapter; and with the 

provisions of part 136, subpart A, and 

§ 91.147 of this chapter by September 

11, 2007. 

* * * * * 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking. 

[FR Doc. 2010–908 Filed 1–19–10; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1500 

Children’s Products Containing Lead; 

Exemptions for Certain Electronic 

Devices 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (CPSC or Commission) is 

issuing a final rule concerning certain 

electronic devices for which it is not 

technologically feasible to meet the lead 

limits as required under section 101 of 

the Consumer Product Safety 

Improvement Act of 2008 (CPSIA).1

DATES: Effective Date: This final rule is 

effective on January 20, 2010. 

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; e-mail 

khatlelid@cpsc.gov; telephone (301) 

504–7254. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The Consumer Product Safety 

Improvement Act of 2008 (CPSIA), 

Public Law 110–314, 122 Stat. 3016, 

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. The limit 


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Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 3155 

will be further reduced to 100 ppm after 

three years, or August 14, 2011, unless 

the Commission determines that it is not 

technologically feasible to meet this 

lower limit. Section 3(a)(16) of the 

Consumer Product Safety Act, as 

amended by section 235(a) of the 

CPSIA, defines ‘‘children’s product’’ as a 

‘‘consumer product designed or 

intended primarily for children 12 years 

of age or younger.’’ 

B. Statutory Authority 

Section 101(b)(2) of the CPSIA 

provides that the lead limits do not 

apply to component parts of a product 

that are not accessible to a child. This 

section specifies 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, as 

determined by the Commission. Paint, 

coatings, or electroplating may not be 

considered to be a barrier that would 

render lead in the substrate to be 

inaccessible to a child. Section 101 

(b)(2)(B) of the CPSIA further provides 

that the Commission shall promulgate a 

rule providing guidance with respect to 

what product components or classes of 

components will be considered to be 

inaccessible. An interpretative rule 

providing guidance on inaccessibility 

(inaccessibility rule) was published in 

the Federal Register on August 7, 2009 

(74 FR 39535). 

In addition, if the Commission 

determines that it is not technologically 

feasible for certain electronic devices to 

comply with the lead limits, section 

101(b)(4) of the CPSIA provides that the 

Commission shall issue requirements by 

regulation to eliminate or minimize the 

potential for exposure to and 

accessibility of lead in such electronic 

devices, and establish a schedule for 

achieving full compliance unless the 

Commission determines that full 

compliance with the lead limits is not 

technologically feasible within such a 

schedule. Under section 101(d) of the 

CPSIA, technological feasibility is based 

on the commercial availability of 

products, technology, or other practices 

that will allow compliance with the lead 

limits. 

On January 15, 2009, the Commission 

issued a notice of proposed rulemaking 

on requirements for certain electronic 

devices that could not comply with the 

lead limits due to technological 

infeasibility (74 FR 2435). The notice of 

proposed rulemaking was withdrawn on 

February 12, 2009 (74 FR 7021). On that 

date, the Commission issued an interim 

final rule (74 FR 6991) to provide 

certain exemptions for children’s 

electronic devices including: 

• Inaccessible lead-containing 

component parts; 

• Accessible lead-containing 

components parts that cannot be 

produced without lead due to the lack 

of technologically feasible substitutions 

and which require lead for the proper 

functioning of the component part; and 

• Lead-containing spare parts or other 

removable components which are 

inaccessible when the product is 

assembled in functional form or is 

otherwise granted an exemption. 

The interim final rule also directed 

Commission staff to reevaluate and 

report to the Commission on the 

technical feasibility of compliance with 

the lead limits, including the 

technological feasibility of making 

accessible component parts 

inaccessible, and the status of the 

exemptions no less than every five years 

after publication of a final rule in the 

Federal Register. Comments on the 

interim final rule were due on March 

16, 2009. 

C. Discussion of Comments to the 

Interim Final Rule 

The Commission received seven 

comments from consumer groups, 

electronics associations, companies, and 

individuals. In general, most comments 

sought to narrow or expand the scope of 

the exemptions. 

1. Summary of the Law—Section 

1500.88(a) 

Section 1500.88(a), in essence, 

summarized the lead content limits in 

children’s products under section 101 of 

the CPSIA and how, over time, the 

limits decrease from 600 ppm to 100 

ppm by August 14, 2011 unless the 

Commission determines that it is not 

technologically feasible to meet this 

lower limit. Section 1500.88(a) also 

stated that, ‘‘Paint, coatings or 

electroplating may not be considered a 

barrier that would make the lead 

content of a product inaccessible to a 

child.’’ 

We did not receive any comment on 

this provision. However, we have, on 

our own initiative, revised the last 

sentence by adding, ‘‘Section 101(b)(2) 

of the CPSIA further provides that the 

lead limits do not apply to component 

parts of a product that are not accessible 

to a child. This section specifies 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, 

as determined by the Commission.’’ 

2. Technological Feasibility—Section 

1500.88(b) 

Section 1500.88(b) explained that if 

the Commission determines that it is not 

technologically feasible for certain 

electronic devices, the Commission 

must issue requirements by regulation 

to eliminate or minimize the potential 

for exposure to and accessibility of lead 

in such electronic devices and establish 

a schedule by which such electronic 

devices shall be in full compliance 

unless the Commission determines that 

full compliance is not technologically 

feasible for such devices within a 

schedule set by the Commission. 

We have, on our own initiative, 

modified this section to add ‘‘within a 

schedule set by the Commission’’ after 

‘‘such devices.’’ This modification 

reflects the statutory language at section 

101(b)(4)(B) of the CPSIA. 

One commenter requested guidance 

regarding the definition of ‘‘electronic 

devices.’’ 

The CPSIA does not provide a 

definition for electronic devices. 

However, we believe a reasonable 

definition of an electronic device is ‘‘a 

device that generates, stores, distributes, 

or converts electrical energy into 

another energy form.’’ Examples of 

children’s electronic devices include, 

but are not limited to, products with 

batteries or power cords (or that use 

solar power or other power sources), 

such as music players, headphones, 

some toys and games, some calculators, 

and certain computers or similar 

electronic learning products. 

3. Certain Lead-Containing Component 

Parts—Section 1500.88(c) 

Section 1500.88(c) provided that 

certain lead-containing component parts 

in electronic devices that are unable to 

meet the lead limits would be granted 

exemptions provided that the use of 

lead is necessary for the proper 

functioning of the component part and 

it is not technologically feasible for the 

component part to meet the lead content 

limits. 

On our own initiative, we have 

modified this section to add the word 

‘‘accessible’’ in between ‘‘certain’’ and 

‘‘lead-containing component parts,’’ to 

make clear that the exemptions in the 

rule are applicable only to accessible 

component parts. Inaccessible 

component parts are already excluded 

from the lead limits under section 

101(b)(2) of the CPSIA. 


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3156 Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 

One commenter stated that the 

exemptions should be narrowed to 

cover only components of electrical 

goods. This commenter asserted that the 

language in the interim final rule could 

be read to exclude general materials that 

contain metal alloys and enable 

manufacturers to add lead although it 

may not be technologically necessary to 

do so. 

The rule was intended to be limited 

to the materials and components 

necessary for the electronic functioning 

of children’s electronic devices. In 

response to the comments, we have 

revised § 1500.88(c) by adding the word 

‘‘electronic’’ before the word 

‘‘functioning.’’ In addition, we have 

further clarified § 1500.88(d) to add the 

word ‘‘electronic’’ before ‘‘component 

parts’’ in the first sentence. Nonfunctional uses of lead in children’s 

electronic devices remain subject to the 

lead content limits under section 101(a) 

of the CPSIA. For example, if the metal 

component part was purely decorative, 

such as a cell phone charm or wrist 

accessory sold with, or attached to, a 

child’s phone, that charm or accessory 

is not necessary to the proper electronic 

functioning of the component part and 

is subject to the lead content limits. 

Another commenter requested that 

the exemptions for the metal alloy 

components in children’s electronic 

devices be extended to products whose 

mechanical functions require the use of 

material containing lead, such as a brass 

collar on the wheel of a toy. The 

commenter also asserted that the 

electronic exemption for ‘‘lead-bronze 

bearing shells and bushings’’ are not 

primarily used for the transmission of 

electrical current, but are mechanical 

devices. 

Section 101(b)(4) of the CPSIA allows 

exemptions to the lead content limits if 

the Commission finds that it is not 

technologically feasible to remove the 

lead from the electronic devices. This 

section does not provide for exemptions 

for other types of products that are 

unrelated to electronic devices. The 

exemptions under this rule include 

bearing shells and bushings only when 

those bearing shells and bushings are 

integral to the operation of certain 

electronic devices, such as electric 

motors. For this reason, lead-bronze 

bearing shells and bushings are allowed 

in children’s electronic devices. 

However, the exemption does not 

extend to bearing shells and bushings in 

children’s products that are unrelated to 

electronic operations because they do 

not fall within the scope of these 

exemptions. Such components must 

comply with the CPSIA’s lead content 

limits. We note that if such components 

are inaccessible to a child, they would 

not be subject to the CPSIA lead content 

limits under 16 CFR 1500.87. 

One commenter stated that the health 

implications of lead exposure from the 

electronic products have not been 

considered and that the interim final 

rule does not provide an incentive to 

improve technology to reduce lead 

content. The commenter also stated that 

exempted products should be labeled as 

to lead content. Another commenter 

stated that no exemptions should be 

granted given the dangerous effects of 

lead in children. 

As discussed in the preamble to the 

interim final rule (74 FR at 6992), the 

complete elimination of lead, or the 

reduction in lead content to the lead 

content limits specified in the CPSIA, is 

currently not technologically feasible for 

certain components of children’s 

electronic products. Accordingly, the 

final rule provides for exemptions from 

the lead limits for a limited number of 

components of electronic devices that 

must be manufactured using lead, 

including in certain metal alloys. Such 

component parts could include power 

cord pins, cathode-ray tubes, and 

electrical connectors. Children are not 

expected to experience significant 

exposures to lead from these few 

applications. The lead containing 

components that are being exempted are 

components that one would not expect 

children to mouth, swallow, or handle 

for significant periods under normal and 

reasonably foreseeable conditions. 

Moreover, with few exceptions, many 

electronic devices will be in compliance 

with the lead limits under the CPSIA 

either because they already meet the 

lead content limits or because the leadcontaining component part is 

inaccessible (74 FR at 6992). 

Furthermore, we do not believe that 

labeling electronic devices for their lead 

content would add to the safety of these 

products. In the absence of the 

exemptions provided for in the CPSIA 

and this rule, certain electronics devices 

would be banned if they were intended 

primarily for children. The likely 

substitute for some of these products 

would be similar products that are 

intended for general consumer use. 

Thus, not providing these exemptions 

could result in increases in the 

children’s lead exposure from products 

intended for general consumer use that 

are not subject either to the lead 

limitations in the CPSIA or the alternate 

lead limits provided for in the 

exemptions under this rule. 

We also disagree with the 

commenter’s assertion that the rule does 

not provide incentives for technological 

improvements. Congress recognized that 

certain electronic devices currently may 

not be able to meet the lead content 

limits. However, under section 101(b)(5) 

of the CPSIA, the Commission 

specifically was directed to periodically 

review and revise the regulations, as 

necessary, no less than every five years. 

The Commission intends to continue to 

evaluate the technological feasibility of 

making accessible component parts 

inaccessible, and to reevaluate the 

exemptions within that time frame as 

provided under § 1500.88(f) of this rule. 

4. Exemptions for Lead—Section 

1500.88(d) 

This section set forth the specific 

exemptions for lead as used in certain 

component parts in children’s products. 

As discussed in part C.3 of this 

preamble, we have added the word 

‘‘electronic’’ before ‘‘component parts’’ in 

the first sentence of § 1500.88(d) to 

make clear that this rule applies to 

materials and components necessary for 

the electronic functioning of children’s 

electronic devices. 

Additionally, on our own initiative, 

we have revised § 1500.88(d)(1) to insert 

a comma between ‘‘electronic 

components’’ and ‘‘and fluorescent 

tubes’’ to clarify that electronic 

components and fluorescent tubes 

should be considered as separate items 

rather than as one item or as synonyms. 

We also have revised § 1500.88(d)(2) to 

replace ‘‘3,500 ppm’’ with ‘‘3,500 ppm,’’ 

for purposes of consistency with how 

the ppm levels are expressed elsewhere 

in the final rule. We also have revised 

§ 1500.88(d)(8) to insert a comma 

between ‘‘the seal frit and frit ring’’ and 

‘‘as well as in print pastes’’ to clarify that 

a seal frit and frit ring are distinct from 

print pastes. 

Commenters representing the 

electronics industry manufacturers 

asserted that the list of exempted 

materials and components in the final 

rule is too limited. They requested that 

the rule incorporate all of the current 

exemptions of the use of lead in the 

European Union’s Restriction on 

Hazardous Substances (EU RoHS) 

directive to avoid inconsistencies and to 

harmonize with other standards. They 

claimed that while ongoing research 

aims to find alternatives and eliminate 

the use of lead, it is not yet 

technologically feasible to avoid all uses 

of lead. The commenters also asserted 

that testing for lead in electronic 

products is difficult and costly. 

We do not believe that it is necessary 

to incorporate into the rule all of the 

exemptions listed in the EU RoHS 

directive. (European Union Directive 

2002/95/EC and amendments to the 

directive are available at http://eurVerDate Nov<24>2008 15:59 Jan 19, 2010 Jkt 220001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\20JAR1.SGM 20JAR1

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Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 3157 

lex.europa.eu/en/index.htm.) The 

European Union and other countries 

and authorities have adopted 

restrictions on the use of lead and other 

chemicals in electronic devices to 

address concerns related to human 

health and environmental impacts of 

waste electrical and electronic 

equipment. The EU RoHS directive 

allows certain exemptions if 

substitution is not possible from the 

scientific and technical point of view or 

if the negative environmental or health 

impacts caused by substitution are 

likely to outweigh the human and 

environmental benefits of the 

substitution. It also specifies that 

exemptions must be reviewed at least 

every four years with the aim of 

removing such exemptions if it becomes 

technologically or scientifically possible 

to replace the lead in a particular 

application. The list of exemptions 

covered under the EU RoHS directive is 

intended to cover all electric and 

electronic equipment. 

The list of exemptions provided 

under this rule is intended to allow the 

use of lead-containing components used 

in children’s products that are necessary 

for the electronic functioning of the 

children’s electronic device. 

Accordingly, the list of exemptions does 

not include exemptions for uses of lead 

in components that have no application 

to, or would not otherwise be used in 

children’s products. For example, 

adopting the EU RoHS directive would 

result in the inclusion of EU RoHS 

directive exemption 23, ‘‘Lead alloys as 

solder for transducers used in highpowered (designed to operate for several 

hours at acoustic power levels of 125dB 

SPL and above) loudspeakers’’ into the 

final rule. Such high powered speakers 

may be appropriate for use in a stadium, 

but are not a children’s product. 

Because the commenters did not 

identify any specific exemption under 

the EU RoHS directive or similar 

directives that may, in fact, require the 

use of lead in a component of children’s 

electronic devices and that also is not 

listed as an exemption under this rule, 

we decline to revise the list of 

exemptions at this time. We note that 

this rule does not preclude the 

commenters from complying with the 

EU RoHS directive if they choose to do 

so. However, if commenters need 

additional exemptions for leadcontaining component parts in 

children’s electronic devices, they can 

submit a petition under the procedures 

set forth under 16 CFR part 1051 with 

the supporting documentation. A 

general request for regulatory action 

which does not reasonably specify the 

type of action requested is not sufficient 

for purposes of a petition request. 16 

CFR 1051.6(a)(5). 

Commenters also requested that the 

rule explicitly state that exempted or 

inaccessible parts are not subject to the 

testing requirement of section 102 of the 

CPSIA. 

With regard to inaccessible 

component parts, the preamble to the 

inaccessibility rule stated that a 

manufacturer currently is not required 

to provide third-party testing to 

demonstrate inaccessibility (74 FR at 

39537). In addition, many of the 

exemptions provided under this rule do 

not require testing under section 102 of 

the CPSIA because there are no lead 

limits associated with the exemptions. 

However, the exemptions for the metal 

alloys are not blanket or absolute 

exemptions. Instead, they are presented 

as alternate lead limits. As such, those 

components, i.e., copper (less than 4 

percent lead by weight), steel (less than 

0.35 percent lead by weight), and 

aluminum (less than 0.4 percent lead by 

weight), must still be tested by the 

manufacturer to verify that these 

component parts comply with these 

higher lead limits 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 in an upcoming rulemaking. 

As for the other specific exemptions 

mentioned in § 1500.88(d), such as lead 

used in compliant pin connector 

systems (§ 1500.88(d)(6)), lead used in 

optical and filter glass (§ 1500.88(d)(7)), 

lead oxide in plasma display panels and 

surface conduction electron emitter 

displays used in structural elements 

(§ 1500.88(d)(8)), and lead oxide in the 

glass envelope of Black Light Blue 

lamps (§ 1500.88(d)(9)), we did not 

receive comments on those provisions. 

Consequently, the final rule retains 

those provisions without change. 

5. Removable or Replaceable Parts— 

Section 1500.88(e) 

This section provided that 

components of electronic devices that 

are removable or replaceable, such as 

battery packs and light bulbs, are not 

subject to the lead content limits if they 

were otherwise granted an exemption, 

or are inaccessible when the product is 

assembled in functional form. 

On our own initiative, we have added 

commas after ‘‘replaceable’’ and 

‘‘exemption’’ to clarify that section for 

readability. 

Several commenters addressed 

removable and replaceable parts. Some 

commenters supported the exemption 

from the lead content limits for such 

parts on the basis that replacing or 

installing parts of a children’s electronic 

device is not a children’s activity. Other 

commenters opposed the exemption 

because children could access the leadcontaining parts when they are not 

installed. 

We decline to revise the rule as 

suggested by some commenters. We 

have determined that removable or 

replaceable parts, such as battery packs 

and light bulbs, that are inaccessible 

when installed in the product, are not 

subject to the lead content requirements. 

When installed, such parts are 

inaccessible under 16 CFR 1500.87. In 

addition, these types of spare parts or 

replacement parts, including battery 

pack and light bulbs, are not intended 

primarily for children since such parts 

are available for general use by the 

public. While spare parts may 

sometimes be included with a children’s 

product, in many instances, the parts, 

necessary for the functioning of the 

electronic device, are to be installed by 

adults, and are inaccessible to children 

once installed. 

One commenter requested guidance 

regarding whether a metal key sold with 

electrical electronic equipment would 

be subject to the lead content limits. 

According to the commenter, keys are 

made with copper alloy and aluminum 

and contain lead of up to 0.4%. The 

commenter stated that substitutes 

containing lead below 300 ppm are 

unavailable. 

The definition of ‘‘children’s product’’ 

means a consumer product designed or 

intended primarily for children 12 years 

of age. A key used in connection with 

a child’s electronic device does not 

necessarily make the key a children’s 

product if the key is intended for an 

adult to use in safeguarding or 

monitoring the use of the electronic 

equipment. In such instances, the key 

would be in the possession of the adult 

at all times, and would not be 

considered a children’s product. In 

other instances, if a key is to be used 

primarily by a child in connection with 

an electronic device, an exemption from 

the lead content limits under the CPSIA 

would apply only in instances where 

such a key is necessary for the 

electronic functioning of the device. 

6. Review Period—Section 1500.88(f) 

This section provides that the 

Commission staff will reevaluate and 

report to the Commission on the 

technological feasibility of compliance 

with the lead content limits for 


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3158 Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 

children’s electronic devices, including 

the technological feasibility of making 

accessible component part inaccessible, 

and the status of the exemptions no less 

than every five years. 

One commenter stated that the EU 

RoHS directive specifies that 

exemptions must be reviewed every four 

years. The commenter requested that the 

Commission adopt the same four year 

review cycle. 

As discussed in part C.4 of this 

preamble, we are not adopting all of the 

exemptions in the EU RoHS directive. 

Accordingly, the Commission’s review 

of the exemptions provided under this 

rule will be based on the application of 

lead in children’s electronic devices. 

Section 101(b)(5) of the CPSIA provides 

that reviews and possible revision must 

occur no less frequently than every five 

years. Thus, we do not believe that the 

rule needs to be revised at this time. 

However, to the extent technological 

advances are made in the next few 

years, such that the existing exemptions 

warrant revision or rescission, we will 

review such changes and consider 

revisions prior to the five year review 

period. 

D. Impact on Small Businesses 

Under the Regulatory Flexibility Act 

(RFA), when an agency issues a 

proposed rule, it generally 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. 

In the preamble to the interim final 

rule (74 FR at 6992), the Commission’s 

Directorate for Economic Analysis 

determined that the exemption for 

certain specified materials from the 

requirements of section 101(a) of the 

CPSIA 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 associated with compliance with 

the lead content limits of the CPSIA. 

Based on the foregoing assessment, the 

Commission certifies that the rule 

would not have a significant impact on 

a substantial number of small entities. 

E. 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 final 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. 

F. 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 final rule is stated in section 18 of 

the Federal Hazardous Substances Act. 

15 U.S.C. 1261n. 

G. 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 and is virtually identical to an 

interim final rule that has been in effect 

since February 10, 2009, the effective 

date for the final rule is January 20, 

2010. 

List of Subjects in 16 CFR Part 1500 

Consumer protection, Hazardous 

materials, Hazardous substances, 

Imports, Infants and children, Labeling, 

Law enforcement, and Toys. 

■ For the reasons stated above, the 

Commission amends chapter II of title 

16 of the Code of Federal Regulations as 

follows: 

PART 1500—HAZARDOUS 

SUBSTANCES AND ARTICLES: 

ADMINISTRATION AND 

ENFORCEMENT REGULATIONS 

■ 1. The authority citation for part 1500 

continues to read as follows: 

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

3016. 

■ 2. Revise § 1500.88 to read as follows: 

§ 1500.88 Exemptions from lead limits 

under section 101 of the Consumer Product 

Safety Improvement Act for Certain 

Electronic Devices. 

(a) The Consumer Product Safety 

Improvement Act (CPSIA) 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 will be further 

reduced to 100 ppm, unless the 

Commission determines that it is not 

technologically feasible to meet this 

lower limit. Section 101(b)(2) of the 

CPSIA further provides that the lead 

limits do not apply to component parts 

of a product that are not accessible to a 

child. This section specifies 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, 

as determined by the Commission. 

Paint, coatings, or electroplating may 

not be considered to be a barrier that 

would render lead in the substrate to be 

inaccessible to a child. 

(b) Section 101(b)(4) of the CPSIA 

provides that if the Commission 

determines that it is not technologically 

feasible for certain electronic devices to 

comply with the lead limits, the 

Commission must issue requirements by 

regulation to eliminate or minimize the 

potential for exposure to and 

accessibility of lead in such electronic 

devices and establish a compliance 

schedule unless the Commission 

determines that full compliance is not 

technologically feasible within a 

schedule set by the Commission. 

(c) Certain accessible lead-containing 

component parts in children’s electronic 

devices unable to meet the lead limits 

set forth in paragraph (a) of this section 

due to technological infeasibility are 

granted the exemptions that follow in 

paragraph (d) of this section below, 

provided that use of lead is necessary 

for the proper electronic functioning of 

the component part and it is not 

technologically feasible for the 

component part to meet the lead content 

limits set forth in paragraph (a) of this 

section. 

(d) Exemptions for lead as used in 

certain electronic components parts in 

children’s electronic devices include: 

(1) Lead blended into the glass of 

cathode ray tubes, electronic 

components, and fluorescent tubes. 

(2) Lead used as an alloying element 

in steel. The maximum amount of lead 

shall be less than 0.35% by weight 

(3,500 ppm). 

(3) Lead used in the manufacture of 

aluminum. The maximum amount of 

lead shall be less than 0.4% by weight 

(4,000 ppm). 

(4) Lead used in copper-based alloys. 

The maximum amount of lead shall be 

less than 4% by weight (40,000 ppm). 

(5) Lead used in lead-bronze bearing 

shells and bushings. 

(6) Lead used in compliant pin 

connector systems. 

(7) Lead used in optical and filter 

glass. 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 75, No. 12 / Wednesday, January 20, 2010 / Rules and Regulations 3159 

(8) Lead oxide in plasma display 

panels (PDP) and surface conduction 

electron emitter displays (SED) used in 

structural elements; notably in the front 

and rear glass dielectric layer, the bus 

electrode, the black stripe, the address 

electrode, the barrier ribs, the seal frit 

and frit ring, as well as in print pastes. 

(9) Lead oxide in the glass envelope 

of Black Light Blue (BLB) lamps. 

(e) Components of electronic devices 

that are removable or replaceable, such 

as battery packs and light bulbs that are 

inaccessible when the product is 

assembled in functional form or are 

otherwise granted an exemption, are not 

subject to the lead limits in paragraph 

(a) of this section. 

(f) Commission staff is directed to 

reevaluate and report to the Commission 

on the technological feasibility of 

compliance with the lead limits in 

paragraph (a) of this section for 

children’s electronic devices, including 

the technological feasibility of making 

accessible component parts 

inaccessible, and the status of the 

exemptions, no less than every five 

years after publication of a final rule in 

the Federal Register on children’s 

electronic devices. 

Dated: January 12, 2010. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2010–877 Filed 1–19–10; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of 

Sponsor’s Name and Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor’s name from Fort 

Dodge Animal Health, A Division of 

Wyeth Holdings Corp. to Fort Dodge 

Animal Health, Division of Wyeth 

Holdings Corp., a wholly owned 

subsidiary of Pfizer, Inc. In a separate 

action, FDA is amending the animal 

drug regulations to reflect a change of 

sponsor’s name from Fort Dodge Animal 

Health, Division of Wyeth to Fort Dodge 

Animal Health, Division of Wyeth, a 

wholly owned subsidiary of Pfizer, Inc. 

In each case, the sponsor’s mailing 

address will be changed. 

DATES: This rule is effective January 20, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, A Division of 

Wyeth Holdings Corp., P.O. Box 1339, 

Fort Dodge, IA 50501 has informed FDA 

of a change of name and mailing address 

to Fort Dodge Animal Health, Division 

of Wyeth Holdings Corp., a wholly 

owned subsidiary of Pfizer, Inc., 235 

East 42d St., New York, NY 10017. In 

a separate action, Fort Dodge Animal 

Health, Division of Wyeth, 800 Fifth St. 

NW., Fort Dodge, IA 50501 has 

informed FDA of a change of name and 

mailing address to Fort Dodge Animal 

Health, Division of Wyeth, a wholly 

owned subsidiary of Pfizer, Inc., 235 

East 42d St., New York, NY 10017. 

Accordingly, the agency is amending 

the regulations in 21 CFR 510.600(c) to 

reflect these changes. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), revise the entries for 

‘‘Fort Dodge Animal Health, A Division 

of Wyeth Holdings Corp.’’ and ‘‘Fort 

Dodge Animal Health, Division of 

Wyeth’’; and in the table in paragraph 

(c)(2), revise the entries for ‘‘000856’’ 

and ‘‘053501’’ to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Fort Dodge Animal Health, 

Division of Wyeth Holdings Corp., a wholly 

owned subsidiary of 

Pfizer, Inc., 235 East 42d 

St., New York, NY 10017 

053501 

Fort Dodge Animal Health, 

Division of Wyeth, a 

wholly owned subsidiary 

of Pfizer, Inc., 235 East 

42d St., New York, NY 

10017 

000856 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

000856 Fort Dodge Animal Health, 

Division of Wyeth, a 

wholly owned subsidiary 

of Pfizer, Inc., 235 East 

42d St., New York, NY 

10017 

* * * * * 

053501 Fort Dodge Animal Health, 

Division of Wyeth Holdings Corp., a wholly 

owned subsidiary of 

Pfizer, Inc., 235 East 42d 

St., New York, NY 10017 

* * * * * 

Dated: January 8, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–930 Filed 1–19–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9475] 

RIN 1545–BF83 

Corporate Reorganizations; 

Distributions Under Sections 

368(a)(1)(D) and 354(b)(1)(B); 

Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 


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