2428 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. 

Therefore, this proposed regulation: (1) 

Is not a ‘‘significant regulatory action’’ 

under Executive Order 12866; (2) is not 

a ‘‘significant rule’’ under Department of 

Transportation (DOT) Regulatory 

Policies and Procedures (44 FR 11034; 

February 26, 1979); and (3) does not 

warrant preparation of a regulatory 

evaluation as the anticipated impact is 

so minimal. Since this is a routine 

matter that will only affect air traffic 

procedures and air navigation, it is 

certified that this proposed rule, when 

promulgated, will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, Subpart I, Section 

40103. Under that section, the FAA is 

charged with prescribing regulations to 

assign the use of the airspace necessary 

to ensure the safety of aircraft and the 

efficient use of airspace. This regulation 

is within the scope of that authority as 

it modifies the High and Low offshore 

airspace areas located off the east coast 

of the United States. 

ICAO Considerations 

As part of this proposal relates to 

navigable airspace outside the United 

States, this proposal is submitted in 

accordance with the International Civil 

Aviation Organization (ICAO) 

International Standards and 

Recommended Practices. 

The application of International 

Standards and Recommended Practices 

by the FAA, Office of System 

Operations Airspace and AIM, Airspace 

& Rules Group, in areas outside the 

United States domestic airspace, is 

governed by the Convention on 

International Civil Aviation. 

Specifically, the FAA is governed by 

Article 12 and Annex 11, which pertain 

to the establishment of necessary air 

navigational facilities and services to 

promote the safe, orderly, and 

expeditious flow of civil air traffic. The 

purpose of Article 12 and Annex 11 is 

to ensure that civil aircraft operations 

on international air routes are 

performed under uniform conditions. 

The International Standards and 

Recommended Practices in Annex 11 

apply to airspace under the jurisdiction 

of a contracting state, derived from 

ICAO. Annex 11 provisions apply when 

air traffic services are provided and a 

contracting state accepts the 

responsibility of providing air traffic 

services over high seas or in airspace of 

undetermined sovereignty. A 

contracting state accepting this 

responsibility may apply the 

International Standards and 

Recommended Practices that are 

consistent with standards and practices 

utilized in its domestic jurisdiction. 

In accordance with Article 3 of the 

Convention, state-owned aircraft are 

exempt from the Standards and 

Recommended Practices of Annex 11. 

The United States is a contracting state 

to the Convention. Article 3(d) of the 

Convention provides that participating 

state aircraft will be operated in 

international airspace with due regard 

for the safety of civil aircraft. Since this 

action involves, in part, the designation 

of navigable airspace outside the United 

States, the Administrator is consulting 

with the Secretary of State and the 

Secretary of Defense in accordance with 

the provisions of Executive Order 

10854. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

1. The authority citation for part 71 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959– 

1963 Comp., p. 389. 

§ 71.1 [Amended] 

2. The incorporation by reference in 

14 CFR 71.1 of FAA Order 7400.9S, 

Airspace Designations and Reporting 

Points, signed October 3, 2008 and 

effective October 31, 2008, is amended 

as follows: 

Paragraph 2003—Offshore Airspace Areas. 

* * * * * 

Atlantic High [Amended] 

That airspace extending upward from 

18,000 feet MSL to and including FL 600 

within the area bounded on the east from 

north to south by the Moncton FIR, New 

York Oceanic CTA/FIR, and the San Juan 

Oceanic CTA/FIR; to the point where the San 

Juan Oceanic CTA/FIR boundary turns 

southwest at lat. 21°14′21′′ N., long. 67°39′02′′ 

W., thence from that point southeast via a 

straight line to intersect a 100-mile radius of 

the Fernando Luis Ribas Dominicci Airport at 

lat. 19°47′28′′ N., long. 67°09′37′′ W., thence 

counter-clockwise via a 100-mile radius of 

the Fernando Luis Ribas Dominicci Airport 

to lat. 18°53′05′′ N., long. 67°47′43′′ W., 

thence from that point northwest via a 

straight line to intersect the point where the 

Santo Domingo FIR turns northwest at lat. 

19°39′00′′ N., long. 69°09′00′′ W., thence from 

that point the area is bounded on the south 

from east to west by the Santo Domingo FIR, 

Port-Au-Prince CTA/FIR, and the Havana 

CTA/FIR; bounded on the west from south to 

north by the Houston Oceanic CTA/FIR, 

southern boundary of the Jacksonville Air 

Route Traffic Control Center and a line 12 

miles offshore and parallel to the U.S. 

shoreline. 

* * * * * 

Paragraph 6007—Offshore Airspace Areas. 

* * * * * 

San Juan Low, PR [Amended] 

That airspace extending upward from 

5,500 feet MSL from the point of intersection 

of the San Juan Oceanic CTA/FIR and Miami 

Oceanic CTA/FIR boundary at lat. 21°14′21′′ 

N., long. 67°39′02′′ W., thence from that point 

southeast via a straight line to intersect a 100- 

mile radius of the Fernando Luis Ribas 

Dominicci Airport at lat. 19°47′28′′ N., long. 

67°09′37′′ W., thence clockwise via a 100- 

mile radius of the Fernando Luis Ribas 

Dominicci Airport to lat. 18°53′05′′ N., long. 

67°47′43′′ W., thence from that point 

northwest via a straight line to intersect the 

point where the Santo Domingo FIR turns 

northwest at lat. 19°39′00′′ N., long. 69°09′00′′ 

W., thence from that point northeast along 

the San Juan CTA/FIR and Miami CTA/FIR 

boundary to the point of beginning. 

* * * * * 

Issued in Washington, DC, on January 5, 

2009. 

Edith V. Parish, 

Manager, Airspace and Rules Group. 

[FR Doc. E9–501 Filed 1–14–09; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1500 

Children’s Products Containing Lead; 

Notice of Proposed Procedures and 

Requirements for a Commission 

Determination or Exclusion 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of proposed procedures 

and requirements. 

SUMMARY: On August 14, 2008, Congress 

enacted the Consumer Product Safety 

mstockstill on PROD1PC66 with PROPOSALS

Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 2429 

Improvement Act of 2008 (CPSIA), 

Public Law 110–314. The Commission 

proposes to establish procedures and 

requirements for: A Commission 

determination that a commodity or class 

of materials or a specific material or 

product does not exceed the lead 

content limits specified under section 

101(a) of the CPSIA; or an exclusion of 

a commodity or class of materials or a 

specific material or product under 

section 101(b), that exceeds the lead 

content limits under section 101(a), but 

which will not result in the absorption 

of any lead into the human body nor 

have any other adverse impact on public 

health or safety. This notice sets out and 

solicits comments on proposed 

procedures and requirements and 

information to be supplied with such 

requests. 

DATES: Written comments and 

submissions in response to this notice 

must be received by February 17, 2009. 

ADDRESSES: Comments on the proposed 

procedures and requirements for 

Commission determinations that 

specific materials or products do not 

exceed the lead content limits should be 

e-mailed to 

Sec101Determinations@cpsc.gov. 

Comments should be captioned 

‘‘Section 101(a) Determinations.’’ 

Comments on the proposed procedures 

and requirements for Commission 

decisions on requests for exclusions 

under section 101(b) should be e-mailed 

to Sec101Exclusions@cpsc.gov. 

Comments should be captioned 

‘‘Section 101(b) Exclusions.’’ Comments 

may also be mailed, preferably in five 

copies, to the Office of the Secretary, 

Consumer Product Safety Commission, 

Room 502, 4330 East West Highway, 

Bethesda, Maryland 20814, or delivered 

to the same address (telephone (301) 

504–7923). Comments also may be filed 

by facsimile to (301) 504–0127. 

Comments on the Paperwork 

Reduction Act burdens posed by these 

proposals should be directed to the Desk 

Officer for the Consumer Product Safety 

Commission, Office of Information and 

Regulatory Affairs, OMB, Washington, 

DC 20503. The Commission asks 

commenters to provide copies of such 

comments to the Commission’s Office of 

the Secretary, with a caption or cover 

letter identifying the materials as 

comments submitted to OMB on the 

proposed collection of information 

requirements in the proposed 

procedures and requirements under 

sections 101(a) and (b) of the CPSIA. 

FOR FURTHER INFORMATION CONTACT: 

Kristina Hatlelid, PhD, 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 

The CPSIA establishes specific limits 

on lead 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. 

B. Legal Considerations 

1. Materials or Products That Do Not 

Exceed the Lead Limits 

Under section 101(a) of CPSIA, 

consumer products designed or 

intended primarily for children 12 years 

old and younger that do not contain 

more than 600 ppm of lead (as of 

February 10, 2009), 300 ppm of lead (as 

of August 14, 2009); 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 not considered to be 

banned hazardous substances under the 

Federal Hazardous Substances Act 

(FHSA). However, in the absence of 

Commission action, children’s products 

remain subject to the testing 

requirements of section 102 of the 

CPSIA (codified at § 14 of the Consumer 

Product Safety Act (CPSA)). 

Under these provisions, for children’s 

products manufactured on and after 

February 10, 2009, general conformity 

certificates certifying that they comply 

with the applicable lead content limit 

are required. The certification must be 

based on tests of each product or a 

reasonable testing program. On and after 

August 14, 2009, absent Commission 

action to the contrary, the certificates 

must be based on testing performed by 

a third-party laboratory whose 

accreditation to perform the testing has 

been accepted by the Commission. 

Comments submitted to the Commission 

suggest that these testing and 

certification requirements will result in 

significant expense for products that 

may be inherently free of lead or 

dangerous lead levels. 

Section 3 of the CPSIA grants the 

Commission general rulemaking 

authority to issue regulations, as 

necessary, to implement the CPSIA. 

There may be certain commodities or 

classes of products or materials that 

inherently do not contain lead or 

contain lead at levels that would not 

exceed the lead content limits under 

section 101(a) of the CPSIA. To the 

extent that such materials or products 

exist, the Commission, either of its own 

initiative or upon the request of an 

interested person, is proposing to 

exercise its CPSIA section 3 authority to 

make determinations that certain 

commodities or classes of material or 

products do not exceed the lead limits 

of section 101(a). This rule proposes a 

procedure by which the Commission 

will address requests for determinations 

that these types of materials or products 

do not and would not exceed the lead 

limits. The effect of such a Commission 

finding would be to relieve that material 

or product from the testing requirement 

of section 102 for purposes of 

supporting the required certification. 

If this proposal is issued in final form, 

the Commission would concentrate its 

efforts on evaluating those materials that 

are commodity-like, are used across 

industry in a number of applications, 

and are subject to detailed consensus 

standards related to lead content and 

other pertinent properties. Given the 

Commission’s resources, requests to 

evaluate individual products of a single 

manufacturer would be assigned a very 

low priority. 

Of course even where a material or 

product has been so relieved of the 

testing requirement, it must still meet 

the statutory lead level requirements in 

actual fact. The Commission will obtain 

and test products in the marketplace to 

assure that this remains the case and 

will take appropriate enforcement 

action in situations where that is not the 

case. 

2. Materials or Products That Exceed the 

Lead Limits 

The Commission is also proposing 

procedures to address requests for 

exclusions for certain products or 

materials that exceed the lead content 

limits in section 101(a). Section 

101(b)(1) of the CPSIA provides that the 

Commission may, by regulation, 

exclude a specific product or material 

that exceeds the lead limits established 

for children’s products under section 

101(a) if the Commission, after notice 

and a hearing, determines on the basis 

of the best-available, objective, peerreviewed, scientific evidence that lead 

in such product or material will neither 

(a) result in the absorption of any lead 

mstockstill on PROD1PC66 with PROPOSALS

2430 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 

1The Supreme Court has held that paper hearing 

procedures are adequate where, in the total context 

of the process, they are deemed to ensure adequate 

notice and a genuine opportunity to explain one’s 

case. Mathews v. Eldridge, 424 U.S. 319, 334–35 

(1976). See also United States v. Florida East Coast 

Railway Co., 410 U.S. 224, 238–41(1973). 

2The Commission notes that the statutory 

language of section 101(b)(1) makes it difficult to 

make a showing that would be adequate to exclude 

any material or product on that basis. 

into the human body, taking into 

account normal and reasonably 

foreseeable use and abuse of such 

product by a child, including 

swallowing, mouthing, breaking, or 

other children’s activities, and the aging 

of the product; nor (b) have any other 

adverse impact on public health or 

safety. 

Under section 101(b) of the CPSIA, 

the Commission is required to provide 

notice and a hearing to consider and 

evaluate the best-available, objective, 

peer-reviewed, scientific data before 

promulgating a rule on exclusions. 

Section 553 of the Administrative 

Procedure Act (APA), provides that after 

notice, the agency must give interested 

persons an opportunity to participate in 

the rule making through submission of 

written data, views, or arguments with 

or without opportunity for oral 

presentation. 5 U.S.C. 553(c). Section 

101(b) does not require a ‘‘hearing on 

the record,’’ which would trigger more 

extensive procedural requirements 

under the APA. Accordingly, for this 

matter the Commission has determined 

that an oral hearing is not necessary to 

satisfy the requirements of due process.1

Given the highly technical nature of the 

information sought—peer-reviewed, 

scientific data—the Commission 

believes that the APA notice and 

comment procedures based on written 

submissions would provide the most 

efficient process for obtaining the 

required information as well as provide 

adequate opportunity for all interested 

parties to participate in the proceedings. 

C. Procedures and Requirements 

1. Inherent Lead Content Level 

Determination 

Any request for a Commission 

determination that a specific material or 

product contains no lead or a lead level 

below the applicable statutory limit 

must be supported by objectively 

reasonable and representative test 

results or other scientific evidence 

showing that the product or material 

does not, and would not, exceed the 

lead limit specified in the request. 

A justification submitted by an 

interested party for a determination 

must include a detailed description of 

the product or material; data on the lead 

content of parts of the product or the 

materials used in the production of a 

product; data or information on 

manufacturing processes through which 

lead may be introduced into the product 

or material; any other information 

relevant to the potential for the lead 

content of the product or material to 

exceed the statutory lead limit specified 

in the request, that is 600 ppm, 300 

ppm, or 100 ppm, as applicable; and 

detailed information on the test 

methods used to support such data, 

including the type of equipment used 

and any other techniques employed, as 

well as a statement as to why the data 

is representative of the lead content of 

such products or materials generally 

and why the assessment of the 

manufacturing processes strongly 

supports a conclusion that they would 

not be a source of lead contamination of 

the product or material, if relevant. 

MSDS sheets will not be sufficient to 

satisfy the representative testing criteria 

because they do not show sufficient 

information regarding lead content. 

Rather, the showing necessary to obtain 

an exclusion must be based on 

objectively reasonable and 

representative testing of the material or 

product. 

As noted above, given the potential 

number of requests for determinations 

that might be submitted to the 

Commission, the Commission would 

evaluate industry-wide applications for 

commodities or classes of materials or 

products based on technical 

specifications or other data suggesting 

that the generic commodity or class of 

materials is representative of that used 

by a number of manufacturers before it 

will review any brand specific products 

or proprietary formulas from individual 

manufacturers. The type of materials or 

product classes that the Commission 

considers may fall within the class for 

priority evaluation might include, but 

not be limited to, materials such as 

paper, vegetable dyes, inks, adhesives, 

fabrics, and the like, provided that 

adequate documentation of the 

technical specifications of the materials 

or products such that they are 

representative of a broad class and 

testing data is provided as to those 

generic products. In time, the 

Commission would apply the same 

criteria on a product by product or 

material by material basis, if necessary, 

and provided it has the resources to do 

so. 

Upon receipt of a complete request for 

a determination, the Commission 

proposes to direct the Office of Hazard 

Identification and Reduction to assess 

the request and make an initial 

determination. If the recommendation is 

to grant the exclusion, the Commission 

will publish a notice of proposed 

rulemaking inviting public comment on 

whether the determination should be 

granted in final form, and the Office of 

Hazard Identification and Reduction 

will review and evaluate the comments 

and supporting documentation before 

making its recommendation to the 

Commission for final agency action. 

2. Exclusion of a Material or Product 

Exceeding Lead Content Limit 

For products that exceed the lead 

content limits prescribed in section 

101(a) of the CPSIA, the Commission 

proposes procedures that will allow the 

Commission to evaluate products or 

materials for possible exclusions under 

section 101(b)(1) of the CPSIA. Under 

this section, such evaluations must be 

based on the best-available, objective, 

peer-reviewed, scientific evidence 

showing that lead in such product or 

material will not result in the absorption 

of any lead into the body, taking into 

account normal and reasonable 

foreseeable use and abuse by a child, 

nor have any other adverse impact on 

health or safety. Therefore, a request for 

an exclusion must be supported by the 

best-available, objective, peer-reviewed, 

scientific evidence that address these 

issues, such as test results indicating 

how much lead is present in the 

product, how much lead comes out of 

the product and the conditions under 

which that may happen, and 

information relating to a child’s 

interaction, if any, with the product.2

Upon receipt of a complete exclusion 

request, the Commission proposes to 

direct the Office of Hazard Identification 

and Reduction to assess the request and 

make an initial determination. If the 

recommendation is to grant the 

exclusion, the Commission will publish 

a notice of proposed rulemaking 

inviting public comment on whether the 

exclusion should be issued in final 

form, and the Office of Hazard 

Identification and Reduction will 

review and evaluate the comments and 

supporting documentation before 

making its recommendation to the 

Commission for final agency action. 

D. Effect of Filing a Lead Content 

Determination or Exclusion Request 

The filing of a request for a lead 

content determination or for an 

exclusion would not have the effect of 

automatically staying the effect of any 

provision or limit under the statutes and 

regulations enforced by the 

Commission. Unless issued in final form 

by the Commission after notice and 

comment, all CPSC requirements related 

to the lead content in the material or 

mstockstill on PROD1PC66 with PROPOSALS

Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 2431 

product and all applicable testing and 

certification requirements would remain 

in full force and effect. CPSIA § 101(e). 

However, the Commission’s ability to 

exercise its enforcement discretion is 

not eliminated nor diminished. 

E. 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. 

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. That assessment 

found that the procedures and 

requirements would only impact those 

firms that wish to seek a formal 

Commission determination or exclusion 

from the requirements. Its only potential 

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, if the request is granted. 

Based on the foregoing assessment, the 

Commission preliminarily finds that the 

proposed rule would not have a 

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 proposed rule 

will not result in any additional use of 

lead over what is occurring at the 

present time. Therefore, the 

Commission does not expect the 

proposal to have any negative 

environmental impact. 

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. Paperwork Reduction Act 

Since the proposed rule would 

require manufacturers to provide certain 

information along with any request for 

a Commission determination or 

exclusion, the proposed rule contains 

‘‘collection of information 

requirements’’ as that term is used in 

the Paperwork Reduction Act, 44 U.S.C. 

3501–3520. Therefore, the proposed rule 

is being submitted to the Office of 

Management and Budget (OMB) in 

accordance with 44 U.S.C. 3507(d) and 

implementing regulations codified at 5 

CFR 1320.11. The estimated costs of 

these requirements will depend on the 

number of requests that are received by 

the Commission. 

The number of manufacturers or 

importers that might seek a 

determination that their products or 

materials do not contain lead or exceed 

the lead content limits or that might 

seek an exclusion from the lead-content 

requirements for their product is not 

currently known. The requirements for 

obtaining a determination or exclusion 

are extensive, which may be a deterrent 

to some firms; however, because a very 

broad range of products, materials and 

components are affected by the lead 

content limits, the number of firms 

seeking such determinations or 

exclusions could be higher than 

expected. It would be expected that the 

firms making such requests would be 

familiar with the product or material for 

which the determination or exemption 

is sought and the required information 

may already be in the firm’s possession 

or easily obtainable. 

Based on comments received on the 

CPSIA lead content provisions thus far, 

staff estimates that a minimum of 

approximately 250 firms may submit 

requests. The burden to assemble the 

information and prepare the 

submission, if performed by a senior 

level management employee, may take 

approximately 40 hours. The 

compensation would be approximately 

$60 an hour (U.S. Department of Labor, 

Bureau of Labor Statistics), and the 

average cost of preparing a submission 

would be about $2,400 ($60 × 40). An 

estimate of the annual burden for the 

information collection could reach 

$600,000. 

An estimate of the burden on the 

federal government to review each 

submission could be as much as 24 

hours at an average hourly wage of $56, 

the equivalent of a GS–14 employee, or 

$1,344 for each submission ($56 × 24). 

If approximately 250 submissions are 

received, the cost of the annual burden 

to the federal government will be 

approximately $336,000. 

I. Effective Date 

The APA generally requires that a 

substantive rule be published not less 

than 30 days before its effective date, 

unless the agency finds for good cause 

shown, that a lesser time period is 

required. 5 U.S.C. 553(d)(3). Because the 

Commission recognizes the need for 

providing procedures for Commission 

determinations and exclusions 

expeditiously, for good cause shown, 

the proposed effective date is the date 

of publication of a final rule in the 

Federal Register. 

J. List of Relevant Documents 

(1) Memorandum from Kristina M. 

Hatlelid, PhD, M.P.H., Toxicologist, 

Directorate for Health Sciences 

‘‘Consumer Product Safety Improvement 

Act of 2008 (CPSIA): Exclusions from 

Compliance with Limits for Lead, 

Certain Materials of Products: Required 

Technical Information.’’ December 

2008. 

(2) Memorandum from Robert 

Franklin, Economist, Directorate for 

Economic Analysis, ‘‘Procedures for 

Determinations Regarding Lead Limits 

and Procedures for Exclusions from 

Lead Limits Under Section 101 of the 

Consumer Product Safety Improvement: 

Small Business and Environmental 

Impacts.’’ December 2008. 

List of Subjects in 16 CFR Part 1500 

Consumer protection, Hazardous 

materials, Hazardous substances, 

Imports, Infants and children, Labeling, 

Law enforcement, and Toys. 

K. Conclusion 

For the reasons stated above, the 

Commission proposes to amend 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 is 

amended to read as follows: 

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

3016. 

2. Add new §§ 1500.89 and 1500.90 to 

read as follows: 

§ 1500.89 Procedures for Determinations 

Regarding Lead Content of Materials or 

Products under Section 101(a) 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 

mstockstill on PROD1PC66 with PROPOSALS

2432 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 

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 meet 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. 

(b) The Commission may, either on its 

own initiative or upon the request of 

any interested person, make a 

determination that a material or product 

does not contain lead levels that exceed 

600 ppm, 300 ppm or 100 ppm. 

(c) To request a determination under 

paragraph (b) of this section, the request 

must: 

(1) Be e-mailed to cpsc-os@cpsc.gov 

and titled ‘‘Section 101 Request for Lead 

Content Determination.’’ Requests may 

also be mailed, preferably in five copies, 

to the Office of the Secretary, Consumer 

Product Safety Commission, Room 502, 

4330 East-West Highway, Bethesda, 

Maryland 20814, or delivered to the 

same address. 

(2) Be written in the English language. 

(3) Contain the name and address, and 

e-mail address or telephone number, of 

the requestor. 

(4) Provide Documentation including: 

(i) A detailed description of the 

product or material; 

(ii) Data on the lead content of parts 

of the product or materials used in the 

production of a product; 

(iii) Data or information on 

manufacturing processes through which 

lead may be introduced into the product 

or material; 

(iv) Any other information relevant to 

the potential for lead content of the 

product or material to exceed the CPSIA 

lead limits that is reasonably available 

to the requestor; 

(v) Detailed information on the relied 

upon test methods for measuring lead 

content of products or materials 

including the type of equipment used or 

any other techniques employed and a 

statement as to why the data is 

representative of the lead content of 

such products or materials generally; 

and 

(vi) An assessment of the 

manufacturing processes which strongly 

supports a conclusion that they would 

not be a source of lead contamination of 

the product or material, if relevant. 

(d) Where a submission fails to meet 

all of the requirements of paragraph (c) 

of this section, the Office of the 

Secretary shall notify the person 

submitting it, describe the deficiency, 

and explain that the request may be 

resubmitted when the deficiency is 

corrected. 

(e) Each complete request for a 

Commission determination will be 

reviewed by the Office of Hazard 

Identification and Reduction who will 

preliminarily recommend granting or 

denying the request. Where the 

preliminary determination is to grant, 

the Commission will publish a notice of 

proposed rulemaking inviting public 

comment on whether the preliminary 

determination should be granted in final 

form, and the Office of Hazard 

Identification and Reduction will 

review and evaluate the comments and 

supporting documentation before 

making its recommendation to the 

Commission for final agency action. 

(f) The filing of a request for a 

determination does not have the effect 

of automatically staying the effect of any 

provision or limit under the statutes and 

regulations enforced by the 

Commission. Even though a request for 

a determination has been filed, unless a 

Commission determination is issued in 

final form after notice and comment, 

materials or products subject to the lead 

limits under section 101 of the CPSIA 

must be tested in accordance with 

section 102 of the CPSIA. 

§ 1500.90 Procedures for Exclusions from 

Lead Limits under Section 101(b) 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. 

(b) Section 101(b)(1) of the CPSIA 

provides that the Commission may 

exclude a specific product or material 

from the lead limits established for 

children’s products under the CPSIA if 

the Commission, after notice and a 

hearing, determines on the basis of the 

best-available, objective, peer-reviewed, 

scientific evidence that lead in such 

product or material will neither: 

(1) Result in the absorption of any 

lead into the human body, taking into 

account normal and reasonably 

foreseeable use and abuse of such 

product by a child, including 

swallowing, mouthing, breaking, or 

other children’s activities, and the aging 

of the product; nor 

(2) Have any other adverse impact on 

public health or safety. 

(c) To request an exclusion from the 

lead limits as provided under paragraph 

(a) of this section, the request must: 

(1) Be e-mailed to cpsc-os@cpsc.gov. 

and titled ‘‘Section 101 Request for 

Exclusion of a Material or Product.’’ 

Requests may also be mailed, preferably 

in five copies, to the Office of the 

Secretary, Consumer Product Safety 

Commission, Room 502, 4330 East West 

Highway, Bethesda, Maryland 20814, or 

delivered to the same address. 

(2) Be written in the English language. 

(3) Contain the name and address, and 

e-mail address or telephone number, of 

the requester. 

(4) Provide Documentation including: 

(i) A detailed description of the 

product or material; 

(ii) Data on the lead content of parts 

of the product or materials used in the 

production of a product; 

(iii) Data or information on 

manufacturing processes through which 

lead may be introduced into the product 

or material; 

(iv) Any other information relevant to 

the potential for lead content of the 

product or material to exceed the CPSIA 

lead limits that is reasonably available 

to the requestor; 

(v) Detailed information on the relied 

upon test methods for measuring lead 

content of products or materials 

including the type of equipment used or 

any other techniques employed and a 

statement as to why the data is 

representative of the lead content of 

such products or materials generally; 

and 

(vi) An assessment of the 

manufacturing processes which strongly 

supports a conclusion that they would 

not be a source of lead contamination of 

the product or material, if relevant. 

(5) Provide best-available, objective, 

peer-reviewed, scientific evidence to 

support a request for an exclusion that 

addresses how much lead is present in 

the product, how much lead comes out 

of the product, and the conditions under 

which that may happen, and 

information relating to a child’s 

interaction, if any, with the product. 

(6) Provide best-available, objective, 

peer-reviewed, scientific evidence that 

is unfavorable to the request that is 

reasonably available to the requestor. 

(d) Where a submission fails to meet 

all of the requirements of paragraph (c) 

of this section, the Office of the 

Secretary shall notify the person 

submitting it, describe the deficiency, 

mstockstill on PROD1PC66 with PROPOSALS

Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Proposed Rules 2433 

and explain that the request may be 

resubmitted when the deficiency is 

corrected. 

(e) Each complete request for 

exclusion will be reviewed by the Office 

of Hazard Identification and Reduction, 

who will preliminarily recommend 

granting or denying the request. Where 

the preliminary determination is to 

grant, the Commission will publish a 

notice of proposed rulemaking inviting 

public comment on whether the 

proposed exclusion should be issued in 

final form, and the Office of Hazard 

Identification and Reduction will 

review and evaluate the comments and 

supporting documentation before 

making its recommendation to the 

Commission for final agency action. 

(f) The filing of a request for exclusion 

does not have the effect of automatically 

staying the effect of any provision or 

limit under the statutes and regulations 

enforced by the Commission. Even 

though a request for an exclusion has 

been filed, unless an exclusion is issued 

in final form by the Commission after 

notice and comment, materials or 

products subject to the lead limits under 

section 101 of the CPSIA are considered 

to be banned hazardous substances if 

they do not meet the lead limits. 

Dated: January 9, 2009. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. E9–715 Filed 1–14–09; 8:45 am] 

BILLING CODE 6335–01–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1500 

Children’s Products Containing Lead; 

Proposed Determinations Regarding 

Lead Content Limits on Certain 

Materials or Products; Notice of 

Proposed Rulemaking 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: On August 14, 2008, Congress 

enacted the Consumer Product Safety 

Improvement Act of 2008 (CPSIA), 

Public Law 110–314, 122 Stat. 3016. 

This notice of proposed rulemaking 

(NPR) initiates a proceeding under 

section 3 of the CPSIA authorizing the 

Commission to issue regulations, as 

necessary, to implement the CPSIA. In 

this document, the Commission solicits 

written comments concerning 

preliminary determinations on certain 

natural, untreated and unadulterated 

materials and metals that have not been 

found to exceed the lead content limits 

prescribed under section 101(a) of the 

CPSIA. 

DATES: Written comments and 

submissions in response to this notice 

must be received by February 17, 2009. 

ADDRESSES: Comments should be 

e-mailed to 

Sec101Determinations@cpsc.gov. 

Comments should be captioned 

‘‘Section 101 Determinations of Certain 

Materials or Products NPR.’’ Comments 

may also be mailed, preferably in five 

copies, to the Office of the Secretary, 

Consumer Product Safety Commission, 

Room 502, 4330 East West Highway, 

Bethesda, Maryland 20814, or delivered 

to the same address (telephone (301) 

504–7923). Comments also may be filed 

by facsimile to (301) 504–0127. 

FOR FURTHER INFORMATION CONTACT: 

Kristina Hatlelid, PhD, 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 do not contain 

more than 600 ppm of lead (as of 

February 10, 2009), 300 ppm of lead (as 

of August 14, 2009); 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 not considered to be 

banned hazardous substances under the 

Federal Hazardous Substances Act 

(FHSA). However, in the absence of 

Commission action, these products and 

materials remain subject to the testing 

requirements of section 102 of the 

CPSIA (codified at § 14 of the Consumer 

Product Safety Act (CPSA)). 

Under these provisions, on and after 

February 10, 2009, general conformity 

certificates certifying that they comply 

with the applicable lead content limit 

are required for children’s products. The 

certification must be based on tests of 

each product or a reasonable testing 

program. On and after August 14, 2009, 

absent Commission action to the 

contrary, the certificates must be based 

on testing performed by a laboratory 

whose accreditation to perform the 

testing has been accepted by the 

Commission. 

Section 3 of the CPSIA grants the 

Commission general rulemaking 

authority to issue regulations, as 

necessary, to implement the CPSIA. 

There may be certain products or 

materials that 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. To the 

extent that such materials or products 

exist, the Commission, of its own 

initiative, is proposing to exercise its 

section 3 authority to make preliminary 

determinations that certain commodities 

or classes of materials or products do 

not exceed the lead limits prescribed in 

section 101(a) of the CPSIA. The effect 

of such a Commission finding 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. Of course 

even where a material or product has 

been so relieved of the testing 

requirement, it must still meet the 

statutory lead level requirements in 

actual fact. The Commission will obtain 

and test products in the marketplace to 

assure that this remains the case and 

will take appropriate enforcement 

action in situations where that is not the 

case. 

B. Proposed Determinations on Certain 

Products and Materials 

The Commission staff identified a 

number of commodities or classes of 

materials that do not inherently contain 

lead or contain lead that does not 

exceed the CPSIA lead limits of 600 

ppm or 300 ppm. 

Certain Natural Materials 

Based on the staff’s review, the 

Commission preliminarily determines 

that the following natural materials do 

not exceed the 600 ppm or 300 ppm 

lead content limits under section 101(a) 

of the CPSIA. These preliminary 

determinations are based on materials 

that are untreated and unadulterated 

with respect to the addition of materials 

or chemicals, including pigments, dyes, 

coatings, finishes or any other 

substance, and that do not undergo any 

processing that could result in the 

addition of lead into the product or 

material: 

1. Precious gemstones: Diamond, 

ruby, sapphire, emerald 

2. Certain semiprecious gemstones 

provided that the mineral or material is 

not based on lead or lead compounds 

and is not associated in nature with any 

mineral that is based on lead or lead 

compounds (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) 

3. Natural or cultured pearls 

4. Wood 

mstockstill on PROD1PC66 with PROPOSALS