[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Rules and Regulations]
[Pages 34067-34070]
[FR Doc No: 2019-13579]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 59, 60, 61, 62, 63, 65, 82, and 763

[FRL-9995-50-Region 1]

Change of Address for Region 1 Reports; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical amendments.

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SUMMARY: The Environmental Protection Agency (EPA) is amending its
regulations to reflect a change in address for submitting certain
reports to EPA's Region 1 office and to correct the addresses for
submitting certain air program reports to the EPA Region 1 states of
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and
Vermont once the state is delegated. This action is editorial in nature
and is intended to provide accuracy and clarity to the agency's
regulations.

DATES: Effective August 16, 2019.

FOR FURTHER INFORMATION CONTACT: Susan Lancey, Air Permits, Toxics, and
Indoor Programs Branch, U.S. Environmental Protection Agency, EPA
Region 1 Office, 5 Post Office Square--Suite 100, (Mail code 05-2),
Boston, MA 02109-3912, telephone number<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background and Purpose

    The EPA is amending its regulations in 40 CFR parts 59, 60, 61, 62,
63, 65, 82 and 763 to reflect a change in the mailing address for EPA's
Region 1 office. The EPA is also amending its regulations in 40 CFR
parts 60, 61, and 65 to reflect a change in the mailing addresses for
the Region 1 states of Connecticut, Maine, Massachusetts, New
Hampshire, Rhode Island and Vermont. This technical amendment merely
updates and corrects the addresses for mailing certain reports and
other information to EPA Region 1's office and to the states of
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and
Vermont once delegated a particular standard in 40 CFR parts 60, 61,
and 65. Consequently, EPA has determined that this rule falls under the
``good cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedures Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation. Under section 553 of
the APA, an agency may find good cause where procedures are
``impractical, unnecessary, or contrary to the public interest.''
Public comment is ``unnecessary'' and ``contrary to the public
interest'' since the mailing address has changed for Region 1 reports
submitted under 40 CFR parts 59, 60, 61, 62, 63, 65, 82 and 763 and
since the Region 1 state mailing addresses have changed for reports
submitted once the state is delegated under 40 CFR parts 60, 61, and
65. Notice in the CFR benefits the public by updating citations.

II. Statutory and Executive Order Reviews

    This final rule implements technical amendments to 40 CFR parts 59,
60, 61, 62, 63, 65, 82, and 763 to reflect a change in address for
reports submitted to EPA's Region 1 office and implements technical
amendments to 40 CFR parts 60, 61, and 65 to reflect a change in
addresses for the states of Connecticut, Maine, Massachusetts, New
Hampshire, Rhode Island and Vermont upon delegation of authority. It
does not otherwise impose or amend any requirements. For that reason,
this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 regulatory action because
this action is not significant under Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
    In addition, it does not involve any technical standards that
require the Agency' consideration of voluntary consensus standards
pursuant to Section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note). It also does not provide
the EPA with the discretionary authority to address, as appropriate,
disproportionate human health or environmental effects, using
practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994). And it does not have Tribal
implications because it would not have a substantial direct effect on
one or more Indian Tribes, on the relationship between Federal
Government and Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.

List of Subjects

Part 59

    Environmental protection, Air pollution control, Confidential
business information, Labeling, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

Parts 60, 61, 62, 63, and 65

    Environmental protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.

Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Exports, Government procurement,
Imports, Labeling, Reporting and recordkeeping requirements.

Part 763

    Environmental protection, Administrative practice and procedure,
Asbestos, Confidential business information, Hazardous substances,
Imports, Intergovernmental relationships, Labeling, Occupational safety
and health, Reporting and recordkeeping requirements, Schools.

    Dated: June 19, 2019.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.

    Title 40 CFR parts 59, 60, 61, 62, 63, 65, 82, and 763 are amended
as follows:

PART 59--NATIONAL VOLATILE ORGANIC COMPOUND EMISSION STANDARDS FOR
CONSUMER AND COMMERCIAL PRODUCTS

0
1. The authority citation for part 59 continues to read as follow:

     Authority: 42 U.S.C 7414 and 7511b(e).

Subpart B--National Volatile Organic Compound Emission Standards
for Automobile Refinish Coatings

0
2. Section 59.107 is amended by revising the Region I address to read
as follows:

Sec.  59.107   Addresses of EPA Regional Offices.

* * * * *
    EPA Region I (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *

Subpart C--National Volatile Organic Compound Emission Standards
for Consumer Products

0
3. Section 59.210 is amended by revising the Region I address to read
as follows:

Sec.  59.210  Addresses of EPA Regional Offices.

* * * * *
    EPA Region I (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *

Subpart D--National Volatile Organic Compound Emission Standards
for Architectural Coatings

0
4. Section 59.409(a) is amended by revising the Region I address to
read as follows:

Sec.  59.409  Addresses of EPA Offices.

    (a) * * *
    EPA Region I (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *

Subpart E--National Volatile Organic Compound Emission Standards
for Aerosol Coatings

0
5. Section 59.512 is amended by revising the Region I address to read
as follows:

Sec.  59.512  Addresses of EPA regional offices.

* * * * *
    EPA Region I (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *

PART 60--NEW SOURCE PERFORMANCE STANDARDS

0
6. The authority citation for part 60 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
7. In Sec.  60.4, amend paragraph (a) by revising the Region I address
and by revising paragraphs (b)(8), (b)(21), (b)(23), (b)(31), (b)(41)
and (b)(47), to read as follows:

Sec.  60.4  Address.

    (a) * * *
    Region I (Connecticut, Maine, Massachusetts, New Hampshire, Rhode
Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *
    (b) * * *
    (8) State of Connecticut, Compliance Analysis and Coordination
Unit, Bureau of Air Management, Department of Energy and Environmental
Protection, 79 Elm Street, 5th Floor, Hartford, CT 06106-5127.
* * * * *
    (21) State of Maine, Maine Department of Environmental Protection,
Bureau of Air Quality, 17 State House Station, Augusta, ME 04333-0017.
* * * * *
    (23) Commonwealth of Massachusetts, Massachusetts Department of
Environmental Protection, Division of Air and Climate Programs, One
Winter Street, Boston, MA 02108.
* * * * *
    (31) State of New Hampshire, New Hampshire Department of
Environmental Services, Air Resources Division, 29 Hazen Drive, P.O.
Box 95, Concord, NH 03302-0095.
* * * * *
    (41) State of Rhode Island, Rhode Island Department of
Environmental Management, Office of Air Resources,

235 Promenade Street, Providence, RI 02908.
* * * * *
    (47) State of Vermont, Agency of Natural Resources, Department of
Environmental Conservation, Air Quality and Climate Division, Davis 2,
One National Life Drive, Montpelier, VT 05620-3802.
* * * * *

PART 61--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS

0
8. The authority citation for part 61 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
9. In Sec.  61.04, amend paragraph (a) by revising the Region I
address, and by revising paragraphs (b)(8), (b)(21), (b)(23), (b)(31),
(b)(41) and (b)(47), to read as follows:

Sec.  61.04  Address.

    (a) * * *
    Region I (Connecticut, Maine, Massachusetts, New Hampshire, Rhode
Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *
    (b) * * *
    (8) State of Connecticut: Compliance Analysis and Coordination
Unit, Bureau of Air Management, Department of Energy and Environmental
Protection, 79 Elm Street, 5th Floor, Hartford, CT 06106-5127.
* * * * *
    (21) State of Maine: Maine Department of Environmental Protection,
Bureau of Air Quality, 17 State House Station, Augusta, ME 04333-0017.
* * * * *
    (23) Commonwealth of Massachusetts, Massachusetts Department of
Environmental Protection, Division of Air and Climate Programs, One
Winter Street, Boston, MA 02108.
* * * * *
    (31) State of New Hampshire, New Hampshire Department of
Environmental Services, Air Resources Division, 29 Hazen Drive, P.O.
Box 95, Concord, NH 03302-0095.
* * * * *
    (41) State of Rhode Island, Rhode Island Department of
Environmental Management, Office of Air Resources, 235 Promenade
Street, Providence, RI 02908.
* * * * *
    (47) State of Vermont, Agency of Natural Resources, Department of
Environmental Conservation, Air Quality and Climate Division, Davis 2,
One National Life Drive, Montpelier, VT 05620-3802.
* * * * *

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
10. The authority citation for part 62 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
11. Section 62.10 is amended by adding a heading to the table and
revising the first entry for the Region I address in the table to read
as follows:

Sec.  62.10  Submission to Administrator.

* * * * *

                         Table 1 to Sec.   62.10
------------------------------------------------------------------------
  Region and jurisdiction covered                  Address
------------------------------------------------------------------------
I--Connecticut, Maine,              Director, Enforcement and Compliance
 Massachusetts, New Hampshire,       Assurance Division, U.S. EPA Region
 Rhode Island, and Vermont.          I, 5 Post Office Square--Suite 100
                                     (04-2), Boston, MA 02109-3912,
                                     Attn: Air Compliance Clerk.

                              * * * * * * *
------------------------------------------------------------------------

PART 63--NATIONAL EMISSIONS STANDARDS FOR HAZARDOUS AIR POLLUTANTS

0
12. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
13. Section 63.13(a) is amended by revising the address for Region I to
read as follows:

Sec.  63.13  Addresses of State air pollution control agencies and EPA
Regional Offices.

    (a)* * *
    EPA Region I (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *

PART 65--CONSOLIDATED FEDERAL AIR RULE

0
14. The authority citation for part 65 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
15. In Sec.  65.14, amend paragraph (a) by revising the Region I
address and by revising paragraphs (b)(7), (b)19), (b)(21), (b)(29),
(b)(39) and (b)(45), to read as follows:

Sec.  65.14  Addresses.

    (a)* * *
    Region I (Connecticut, Maine, Massachusetts, New Hampshire, Rhode
Island, Vermont) Director, Enforcement and Compliance Assurance
Division, U.S. EPA Region I, 5 Post Office Square--Suite 100 (04-2),
Boston, MA 02109-3912, Attn: Air Compliance Clerk.
* * * * *
    (b) * * *
    (7) Connecticut. Compliance Analysis and Coordination Unit, Bureau
of Air Management, Department of Energy and Environmental Protection,
79 Elm Street, 5th Floor, Hartford, CT 06106-5127.
* * * * *
    (19) Maine. Maine Department of Environmental Protection, Bureau of
Air Quality, 17 State House Station, Augusta, ME 04333-0017.
* * * * *
    (21) Massachusetts. Massachusetts Department of Environmental
Protection, Division of Air and Climate Programs, One Winter Street,
Boston, MA 02108.
* * * * *

    (29) New Hampshire. New Hampshire Department of Environmental
Services, Air Resources Division, 29 Hazen Drive, P.O. Box 95, Concord,
NH 03302-0095.
* * * * *
    (39) Rhode Island. Rhode Island Department of Environmental
Management, Office of Air Resources, 235 Promenade Street, Providence,
RI 02908.
* * * * *
    (45) Vermont. Agency of Natural Resources, Department of
Environmental Conservation, Air Quality and Climate Division, Davis 2,
One National Life Drive, Montpelier, VT 05620-3802.
* * * * *

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
16. The authority for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

Subpart B--Servicing of Motor Vehicle Air Conditioners

0
17. Section 82.42 is amended by revising paragraph (a)(1)(iii)(A) to
read as follows:

Sec.  82.42   Certification, recordkeeping and public notification
requirements.

    (a) * * *
    (1) * * *
    (iii) * * *
    (A) Owners or lessees of recycling or recovery equipment having
their places of business in Connecticut, Maine, Massachusetts, New
Hampshire, Rhode Island, and Vermont must send their certifications to:
CAA section 609 Enforcement Contact; EPA Region I; Mail Code 04-2; 5
Post Office Square--Suite 100, Boston, MA 02109-3912.
* * * * *

PART 763--ASBESTOS-CONTAINING MATERIAL IN SCHOOLS

0
18. The authority for part 763 continues to read as follows:

     Authority: 15 U.S.C. 2605, 2607(c), 2643, and 2646.

Subpart E--Asbestos Containing Materials in Schools

0
19. Appendix C to subpart E is amended by revising the address for
Region I under II.C.3 to read as follows:

Appendix C to Subpart E of Part 763--Asbestos Model Accreditation Plan

* * * * *
    II. * * *
    C. * * *
    3. * * *
    EPA, Region 1, Asbestos Coordinator, 5 Post Office Square--Suite
100 (05-4), Boston, MA 02109-3912,<PHONE_NUMBER>.
* * * * *

0
20. Appendix D to subpart E is amended by revising the address for
Region I address to read as follows:

Appendix D to Subpart E of Part 763--Transport and Disposal of Asbestos
Waste

* * * * *

Region I

    Asbestos NESHAPs Contact, Enforcement and Compliance Assurance
Division, USEPA, Region I, 5 Post Office Square--Suite 100 (05-4),
Boston, MA 02109-3912,<PHONE_NUMBER>.
* * * * *
[FR Doc. 2019-13579 Filed 7-16-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76275]
[DOCID:fr23de05-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-30-000]

Panhandle Eastern Pipe Line Company, LP; Notice of Application

December 13, 2005.
    Take notice that Panhandle Eastern Pipe Line Company, LP
(Panhandle), P.O. Box 4967, Houston, Texas 77210-4967, filed in Docket
No. CP06-30-000 on December 5, 2005, an application pursuant to section
7(b) of the Natural Gas Act (NGA), for authorization to abandon, by
sale, to Vectren Energy Delivery of Ohio, Inc. (Vectren) and DPL
Energy, LLC (DPLE). Panhandle proposes to abandon certain pipeline
facilities known as the Dayton Facilities which includes the Glen Karn
Pipeline consisting of 44.1-miles of 16-inch diameter pipe and the
Shelby Pipeline consisting of 19.73-miles of 6-inch diameter pipe,
located in Darke and Shelby Counties, Ohio, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection. This filing may be also viewed on the Web at http://www.ferc.gov
 using the ``eLibrary'' link. Enter the docket number

excluding the last three digits in the docket number field to access
the document. For assistance, call<PHONE_NUMBER> or TTY, (202) 208-
3676.
    Any questions regarding this application should be directed to
William W. Grygar, Vice President of Rates and Regulatory Affairs, 5444
Westheimer Road, Houston, Texas 77056-5306 at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link.
    Comment Date: January 3, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7742 Filed 12-22-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Proposed Rules]
[Pages 52171-52173]
[FR Doc No: 2018-22277]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0901; Product Identifier 2018-NM-114-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 737-100, -200, -200C, -300, -400, and
-500 series airplanes. This proposed AD was prompted by reports that
frame web and frame integral inboard chord cracking is occurring on
multiple airplanes in multiple locations below the passenger floor.
This proposed AD would require repetitive detailed, general visual, and
high frequency eddy current (HFEC) inspections of the section 43 lower
lobe frames at certain stations; an inspection to determine if certain
repairs are installed; and applicable on-condition actions. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by November 30,
2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this referenced service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2018-0901.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0901; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Lu Lu, Aerospace Engineer, Airframe
Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA
98198; phone and fax:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0901;
Product Identifier 2018-NM-114-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports indicating that frame web and frame
integral inboard chord cracking is occurring on multiple airplanes in
multiple locations below the passenger floor in section 43 from station
(STA) 380 to STA 520. This condition, if not addressed, could result in
the failure of one or more frames. The failure of multiple frames or
the combination of a severed frame and cracks in fuselage chem-milled
pockets in this area could lead to uncontrolled decompression of the
airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1361, dated July
17, 2018. The service information describes procedures for repetitive
detailed, general visual, and HFEC inspections of the section 43 lower
lobe frames from STA 380 to STA 520; a general visual inspection to
determine if certain repairs are installed; and applicable on-condition
actions. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified as ``RC'' (required for compliance) in the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1361, dated July
17, 2018, described previously, except for any differences identified
as exceptions in the regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2018-0901.

Costs of Compliance

    We estimate that this proposed AD affects 262 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
          Action                   Labor cost           Parts cost      Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspections..............  Up to 84 work-hours x $85              $0  Up to $7,140 per      Up to $1,870,680 per
                            per hour = $7,140 per                      inspection cycle.     inspection cycle.
                            inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes to the Director of the System Oversight
Division.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2018-0901; Product Identifier
2018-NM-114-AD.

(a) Comments Due Date

    We must receive comments by November 30, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 737-100, -200, -
200C, -300, -400, and -500 series airplanes, certificated in any
category, as identified in Boeing Alert Service Bulletin 737-
53A1361, dated July 17, 2018.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports that frame web and frame
integral inboard chord cracking is occurring on multiple airplanes
in multiple locations below the passenger floor. We are issuing this
AD to address frame cracking, which could result in the failure of
multiple frames or the combination of a severed frame and cracks in
fuselage chem-milled pockets in this area, which could lead to
uncontrolled decompression of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) For airplanes identified as Group 1 in Boeing Alert Service
Bulletin 737-53A1361, dated July 17, 2018: Within 120 days after the
effective date of this AD, inspect the airplane and do all
applicable corrective actions using a method approved in accordance
with the procedures specified in paragraph (i) of this AD.
    (2) For airplanes identified as Groups 2 through 6 in Boeing
Alert Service Bulletin 737-53A1361, dated July 17, 2018: Except as
required by paragraph (h) of this AD, at the applicable times
specified in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1361, dated July 17, 2018, do all applicable actions
identified as ``RC'' (required for compliance) in, and in accordance
with, the Accomplishment Instructions of Boeing Alert Service
Bulletin 737-53A1361, dated July 17, 2018

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Service Bulletin 737-53A1361, dated
July 17, 2018, uses the phrase ``the original issue date of this
service bulletin,'' this AD requires using ``the effective date of
this AD.''
    (2) Where Boeing Alert Service Bulletin 737-53A1361, dated July
17, 2018, specifies contacting Boeing for repair instructions or
contacting Boeing for alternative inspections: This AD requires
doing the repair, or the alternative inspections and applicable on-
condition actions, using a method approved in accordance with the
procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs

for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (j)(2) of this AD. Information may be
emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Los Angeles ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.
    (4) Except as required by paragraph (h)(2) of this AD: For
service information that contains steps that are labeled as RC, the
provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact Lu Lu, Aerospace
Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].
    (2) For information about AMOCs, contact George Garrido,
Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch,
3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-
5232; fax:<PHONE_NUMBER>; email: [email protected].
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on October 4, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-22277 Filed 10-15-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56250-56252]
[FR Doc No: 2017-25684]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-E-1195 and FDA-2016-E-1534]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Senza Spinal Cord Stimulation System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Senza Spinal Cord
Stimulation System and is publishing this notice of that determination
as required by law. FDA has made the determination because of the
submission of applications to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
a patent which claims that medical device.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by January
29, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by May 29, 2018. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 29, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2016-E-1195 and FDA-2016-E-1534 for Determination of Regulatory
Review Period for Purposes of Patent Extension; SENZA SPINAL CORD
STIMULATION SYSTEM. Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.

     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device Senza Spinal Cord
Stimulation System. Senza Spinal Cord Stimulation System is indicated
as an aid in the management of chronic intractable pain of the trunk
and/or limbs, including unilateral or bilateral pain associated with
the following: Failed back surgery syndrome, intractable low back pain,
and leg pain. Subsequent to this approval, the USPTO received patent
term restoration applications for Senza Spinal Cord Stimulation System
(U.S. Patent Nos. 8,712,533 and 8,768,472) from Nevro Corporation, and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of SENZA Spinal Cord
Stimulation System represented the first permitted commercial marketing
or use of the product. Thereafter, the USPTO requested that FDA
determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
Senza Spinal Cord Stimulation System is 1,136 days. Of this time, 820
days occurred during the testing phase of the regulatory review period,
while 316 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: March 30, 2012. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was March 30, 2012.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 27,
2014. FDA has verified the applicant's claim that the premarket
approval application (PMA) for SENZA SPINAL CORD STIMULATION SYSTEM
(PMA P130022) was initially submitted June 27, 2014.
    3. The date the application was approved: May 8, 2015. FDA has
verified the applicant's claim that PMA P130022 was approved on May 8,
2015.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 312 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984). Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25684 Filed 11-27-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 29, 2008 (Volume 73, Number 19)]
[Rules and Regulations]
[Page 5109-5115]
[DOCID:fr29ja08-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 716

[EPA-HQ-OPPT-2007-0487; FRL-8154-2]
RIN 2070-AB11

Health and Safety Data Reporting; Addition of Certain Chemicals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule, issued pursuant to section 8(d) of the Toxic
Substances Control Act (TSCA) and its regulations, requires
manufacturers (including importers) of consumer products intended for
use by children who also manufacture (including import) lead or lead
compounds to report certain unpublished health and safety data to EPA.
This final rule adds lead and lead compounds to 40 CFR 716.120 because
the Interagency Testing Committee (ITC) added the category of lead and
lead compounds to the Priority Testing List through its 60\th\ ITC
Report. The ITC was established under section 4(e) of TSCA to recommend
chemicals and chemical mixtures to EPA for priority testing
consideration; the ITC periodically amends the TSCA section 4(e)
Priority Testing List through periodic reports submitted to EPA.

DATES: This final rule is effective on February 28, 2008. For purposes
of judicial review, this final rule shall be promulgated at 1 p.m.
eastern daylight/standard time on February 12, 2008. (See 40 CFR 23.5.)
    A request to withdraw a chemical from this final rule pursuant to
40 CFR 716.105(c) must be received on or before February 12, 2008. (See
Unit IV. of the SUPPLEMENTARY INFORMATION.)
    For dates for reporting requirements, see Unit III.B. of the
SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-0487, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.

     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC,
Attention: Docket ID Number EPA-HQ-OPPT-2007-0487. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-0487. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' systems,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://www.regulations.gov
, or, if only available in hard copy, at the OPPT

Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.
    Data Submissions: Copies of health and safety studies and
accompanying cover letters, lists of health and safety studies,
requests for extensions of time, and withdrawal requests must be
submitted in accordance with the instructions in 40 CFR 716.30, 716.35,
716.60, and 716.105, respectively. Each submission must be identified
by docket ID number EPA-HQ-OPPT-2007-0487.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: Joe Nash, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may potentially be affected by this action if you manufacture
(including import) consumer products intended for use by children and
also manufacture (including import) lead or lead compounds. Importers
are a subset of manufacturers under TSCA.
    Potentially affected entities may include, but are not limited to:
     Manufacturers (including importers) of costume jewelry and
novelty manufacturing (NAICS code 339914).
     Manufacturers (including importers) of dolls and stuffed
toys (NAICS code 339931).
     Manufacturers (including importers) of games, toys, and
children's vehicles (NAICS code 339932).
     Manufacturers (including importers) of fasteners, buttons,
needles, and pins (NAICS code 339993).
     Wholesalers of toy and hobby goods, establishments with
product line 12812 (NAICS code 42392).
     Discount department stores (NAICS code 452112).
     Warehouse clubs and supercenters (NAICS code 45291).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Do I Submit CBI Information?

    Do not submit this information to EPA through regulations.gov or e-
mail. Clearly mark the part or all of the information that you claim to
be CBI. For CBI information in a disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.

II. Background

A. What Action is the Agency Taking?

    EPA is amending its model Health and Safety Data Reporting rule
under TSCA section 8(d) (TSCA section 8(d) model rule) to require
manufacturers (including importers) of consumer products intended for
use by children who also manufacture (including import) lead or lead
compounds, as listed on the ITC's TSCA section 4(e) Priority Testing
List, to submit certain unpublished health and safety data to EPA. The
import of children's products

that contain lead or lead compounds constitutes the manufacture of lead
or lead compounds under TSCA. EPA believes importers of such products
are the entities most likely to have the type of health and safety
studies EPA is seeking.
    Based on information available to the Agency, EPA believes that
imported items represent a majority of the value of sales of toys and
games (without regard to lead content) in NAICS code 42392. In
addition, EPA has reviewed Consumer Product Safety Commission (CPSC)
recalls of lead-contaminated children's products. None of the recalls
reviewed implicated products that were produced domestically. See CPSC
Recalls and Product Safety News at http://www.cpsc.gov/cpscpub/prerel/prerel.html
 (Ref. 1).

    Processors are not included in this final rule. As explained in
Unit II.B., the ITC listing procedure and the TSCA section 8(d) model
rule do not generally result in TSCA section 8(d) model rules that
cover processors. Therefore, a domestic company that processes lead in
the manufacture of children's products would not be covered, unless
that company also manufactures (including imports) lead or lead
compounds.
    The regulatory text of this document lists examples of chemicals
and their CAS numbers in the category of lead and lead compounds. The
regulatory text also lists the data reporting requirements imposed by
this amendment to the TSCA section 8(d) model rule.

B. What is the Agency's Authority?

    Section 8(d) of TSCA allows EPA to ``promulgate rules under which
the Administrator shall require any person who manufactures, processes
or distributes in commerce or who proposes to manufacture, process or
distribute in commerce any chemical substance or mixture'' to submit
lists of certain health and safety studies, as well as copies of such
studies (15 U.S.C. 2607(d)). Under TSCA, import is included in the
definition of ``manufacture'' (15 U.S.C. 2602(7)).
    The TSCA section 8(d) model rule (15 U.S.C. 2607(d)) is codified at
40 CFR part 716. EPA uses this TSCA section 8(d) model rule to quickly
gather current information on chemicals. The TSCA section 8(d) model
rule requires past, current, and prospective manufacturers, importers,
and (if specified by EPA in a particular rule under TSCA section 8(d))
processors of listed chemicals to submit to EPA copies and lists of
unpublished health and safety studies on the listed chemicals that they
manufacture, import, or (if specified by EPA in a particular rule under
TSCA section 8(d)) process. These studies provide EPA with useful
information and have provided significant support for EPA's
decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
    The TSCA section 8(d) model rule provides for the addition of TSCA
section 4(e) Priority Testing List chemicals. Whenever EPA announces
the receipt of an ITC report, EPA amends, unless otherwise instructed
by the ITC, the TSCA section 8(d) model rule by adding the recommended
(or designated) chemicals. In doing so, EPA must provide a 14-day
period, which starts 14 days after date of publication of the
amendments to the TSCA section 8(d) model rule in the Federal Register,
for persons to submit information showing why a chemical substance,
mixture, or category of chemical substances should be withdrawn from
the amendment. The amendment adding these chemicals to the TSCA section
8(d) model rule is effective 30 days after date of publication in the
Federal Register. If the Administrator withdraws a chemical from the
amendment, then no later than 30 days after the date of publication of
the amendment in the Federal Register, a Federal Register document
announcing this decision is published.
    Explanations of the procedures to follow if a respondent to this
rule wishes to assert a claim of confidentiality for a part of a study
or certain information contained in a study are provided at 40 CFR
716.55.

C. Related Obligations Under TSCA Section 8

    Aside from obligations that will arise under this final rule,
persons who manufacture, process, or distribute lead may be subject to
other requirements under TSCA section 8. For example, TSCA section 8(e)
(15 U.S.C. 2607(e)) requires that:
    Any person who manufactures, processes, or distributes in
commerce a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or
mixture presents a substantial risk of injury to health or the
environment shall immediately inform the Administrator of such
information unless such person has actual knowledge that the
Administrator has been adequately informed of such information.

    Toxicity data that indicate a substantial risk of injury to health
or the environment are the most common kinds of information received by
EPA under TSCA section 8(e), but the Agency also often receives
information on exposure, environmental persistence, or other kinds of
information that indicate a substantial risk of injury to health or the
environment. Of note, given the focus of this TSCA section 8(d) model
rule, EPA issued guidance in September 2006 (Ref. 2) that may be
relevant to persons who manufacture, process, or distribute lead-
containing products intended for use by children. The guidance
discusses the circumstances under which reporting under TSCA section
8(e) should be considered for substantial risk information obtained
that indicates:
    1. Previously unknown and significant human exposure to a chemical
known to cause serious health effects (e.g., absorption of a chemical
from manufactured products or articles) or
    2. The presence of a previously unknown hazardous or toxic
constituent in a product, including manufactured articles. Other
guidance and information relevant to TSCA section 8(e) reporting are
available on the TSCA section 8(e) website at http://www.epa.gov/oppt/tsca8e/index.htm
.

D. Why is this Action Being Issued as a Final Rule?

    EPA is publishing this action as a final rule without prior notice
and an opportunity for comment pursuant to the procedures set forth in
40 CFR 716.105(b) and (c). EPA finds that there is ``good cause'' under
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(3)(B)) to make
these amendments without prior notice and comment. EPA believes notice
and an opportunity for comment on this action are unnecessary. TSCA
directs the ITC to add chemicals to the Priority Testing List for which
EPA should give priority consideration. EPA also lacks the authority to
remove a chemical from the Priority Testing List once it has been added
by the ITC. As explained earlier in this preamble, pursuant to 40 CFR
716.105(b) and (c), once the ITC adds a chemical to the Priority
Testing List, EPA in turn is obliged to add that chemical to the list
of chemicals subject to the TSCA section 8(d) model rule reporting
requirements, unless requested not to do so by the ITC. EPA promulgated
this procedure in 1985 after having solicited public comment on the
need for and mechanics of this procedure (Ref. 3). Because that rule
established the procedure for adding ITC chemicals to the TSCA section
8(d) model rule, it is unnecessary to request comment on the procedure
in this action. Finally, 40 CFR 716.105(b) and (c) do provide EPA with
the discretion to withdraw a chemical from the TSCA

section 8(d) model rule if a party submits to EPA information showing
good cause that a chemical should be removed from the TSCA section 8(d)
model rule.

III. Final Rule

A. What Chemicals Are to be Added?

    In this document, EPA is adding the category of lead and lead
compounds to the TSCA section 8(d) model rule as requested by the ITC
in its 60\th\ ITC Report (Ref. 4). This final rule requires
manufacturers (including importers) of consumer products intended for
use by children who also manufacture (including import) lead or lead
compounds to report certain unpublished health and safety data to EPA.

B. What Are the General Reporting Requirements and Deadlines?

    The general provisions regarding the submission of copies and lists
of studies under EPA's TSCA section 8(d) model rule are located at 40
CFR 716.30 and 716.35, respectively, and additional reporting
requirements and exemptions are described elsewhere in 40 CFR part 716.
The reporting schedule and reporting period for persons subject to this
final rule are described at 40 CFR 716.60 and 716.65. Chemical specific
reporting requirements appear at 40 CFR 716.21.

C. What Are the Chemical Specific Reporting Requirements?

    Pursuant to 40 CFR 716.20(b)(5), this amendment specifies the types
of environmental fate, health, and/or environmental effects studies
that must be reported and the chemical grade/purity requirements that
must be met or exceeded in individual studies for lead and lead
compounds. The amendment requires the submission of all unpublished
health and safety studies that:
    1. Relate to the lead content of consumer products that are
``intended for use by children'' as that term is defined at 40 CFR
710.43 (excluding children's metal jewelry, as described by CPSC in its
ANPRM) (Ref. 5), or
     2. Assess children's exposure to lead from such products
(including studies of bioavailability). With regard to grade/purity
requirements, studies showing any measurable lead content in such
products must be submitted.
    The exclusion for children's metal jewelry functions to exempt
studies on those products already being directly addressed by CPSC. For
more information on CPSC's actions, please see CPSC's Advance Notice of
Proposed Rulemaking (ANPRM) regarding children's jewelry containing
lead (Ref. 5).
This final rule does not require reporting of any other health and
safety studies.
    This amendment also specifies manufacturers subject to these
reporting requirements: Manufacturers (including importers) of consumer
products intended for use by children who also manufacture (including
import) lead or lead compounds.

D. Economic Analysis

    The economic analysis for the addition of lead and lead compounds
to the TSCA section 8(d) model rule is entitled, TSCA Section 8(d):
Economic Impact Analysis for Adding Lead and Lead Compounds from the
60\th\ Report of the TSCA Interagency Testing Committee to the Health
and Safety Data Reporting rule. November 14, 2007. (Ref. 6).
    The number of firms that will be affected by this final rule could
not be estimated directly by EPA in the Economic Analysis. In most
previous instances, the TSCA section 8(d) analysis has focused on the
firms that manufacture the chemicals, as shown in the EPA-maintained
Chemical Update System (CUS) database. In this instance, the CUS
database does not include those companies that manufacture (including
import) consumer products intended for use by children as well as
manufacture (including import) lead or lead compounds. Importers are a
subset of manufacturers under TSCA.
    Reporting requirements are further limited to those studies that
relate to the lead content of consumer products (excluding metal toy
jewelry) that are intended for use by children or studies that assess
children's exposure to lead from such products (including studies of
bioavailability).
    The U.S. Census Bureau's Economic Census does not separately
identify these firms. As a result, it is difficult to estimate the
number of firms affected by this rule. The Agency has chosen to
estimate the number of affected firms by using census data of the
number of firms included in certain NAICS categories, selected with the
expectation that these categories include firms which may be engaged in
manufacturing or importing children's products. The selected categories
and the number of firms in each are:
     NAICS code 339914--Costume jewelry and novelty
manufacturing (651 firms).
     NAICS code 339931--Doll and stuffed toy manufacturing (134
firms).
     NAICS code 339932--Game, toy, and children's vehicle
manufacturing (733 firms).
     NAICS code 339993--Fastener, button, needle, and pin
manufacturing (180 firms).
     NAICS code 42392--Toy and hobby goods and supplies
merchant wholesalers (establishments with product line 12812) (1,310
firms).
     NAICS code 452112--Discount department stores (39 firms).
     NAICS code 45291--Warehouse clubs and supercenters (16
firms).
    It is expected that some number of firms within those categories
will not need to respond, and that some other unknown number of firms
not within those categories will be required to respond. This
tabulation is meant to be suggestive of the potential number of
respondents, given the available information, and cannot be expected to
be an accurate point estimate.
    The number of studies that might be submitted in response to this
final rule is also difficult to estimate. The number of firms involved
is likely to be larger than for other chemicals that have been listed
under amendments to the TSCA section 8(d) model rule. However, the
nature of the studies required to be submitted are restricted to a
specific category.
    An earlier examination of studies submitted under previous
amendments to the TSCA section 8(d) model rule over an 8 year period
prior to April 2002 reported an average of 5.66 studies per chemical.
An examination of more recent experience with amendments to the TSCA
section 8(d) model rule reported an average of 1 study per chemical.
Based both on past EPA experience and on the professional judgment of
Agency personnel responsible for the TSCA section 8(d) program, EPA
estimates an average of 5 studies will be submitted for each of the 12
chemicals listed as examples of chemicals in the lead and lead
compounds category, for a total of 60 studies. However, in
consideration of the uncertainty of this per chemical estimate and the
fact that relevant studies on lead compounds other than the listed 12
example compounds may be reported, the Economic Analysis also estimates
the costs in a case where 10 times that number, or 600, studies are
submitted (Ref. 6).
    Given the assumptions in this unit, the industry reporting costs
and burden associated with this rule are estimated in the Economic
Analysis (Ref. 6) to be the following:

                                                  Industry Reporting Costs (Dollars) and Burden (Hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                (c) Number of Firms   (d) = (a) x (c) Total  (e) = (b) x (c) Total
        Collection Activity           (a) Unit Burden Hours       (b) Unit Cost      or Sites Per Activity       Burden Hours               Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Review of rule                    2 hours                 $126.66                 3,063                  6,126                  $387,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
2. Site identification               3 hours                 $189.99                 1,317                  3,951                  $250,584
--------------------------------------------------------------------------------------------------------------------------------------------------------
3. Site file search                  3 hours                 $161.34                 1,361                  4,083                  $219,584
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. Study title lists                 1 hour                  $26.40                  60                     60                     $1,584
--------------------------------------------------------------------------------------------------------------------------------------------------------
5. Photocopy studies                 0.5 hour                $13.20                  60                     30                     $792
--------------------------------------------------------------------------------------------------------------------------------------------------------
6. Robust summaries                  6 hours                 $322.68                 6                      36                     $1,936
--------------------------------------------------------------------------------------------------------------------------------------------------------
7. CBI review                        1 hour                  $63.33                  60                     60                     $3,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
8. Post-reporting period submission  1.5 hours               $76.53                  1                      1.5                    $77
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                14,347                 $865,949
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Not all respondents perform all activities.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The sensitivity analysis conducted to estimate the costs if 600
studies are submitted suggests that the burden estimate for this TSCA
section 8(d) action is relatively insensitive to the estimate of the
number of studies. A ten-fold error in that estimate is calculated to
lead to an increase of roughly 1,500 burden hours (or less than 12%),
and an increase of about $74,000 in cost (or less than 10%). The burden
and cost estimates are largely determined by the estimate of the number
of responding firms, and is relatively insensitive to the estimate of
the number of studies.
    The estimated annual cost of the TSCA section 8(d) model rule to
the Federal Government is approximately the time of one full-time
employee, or 2,080 hours. Based on previous TSCA section 8(d) analyses
and Agency professional judgment, this particular data collection is
expected to represent 25% of 1 year's burden, or the equivalent of
approximately 520 hours. That will amount to a cost to Federal
Government of $25,285.

IV. Requesting a Chemical be Withdrawn from the Rule

    As specified in 40 CFR 716.105(c), EPA may remove a chemical
substance, mixture, or category of chemical substances from this final
rule for good cause prior to the effective date of this final rule. Any
person who believes that the reporting required by this final rule is
not warranted for a chemical substance, mixture, or category of
chemical substances listed in this final rule, must submit to EPA
detailed reasons for that belief. You must submit your request to EPA
on or before February 12, 2008 and in accordance with the instructions
provided in 40 CFR 716.105(c), which are briefly summarized here. In
addition, to ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPPT-2007-0487 on your request and submit that request in
accordance with the instructions in 40 CFR 716.105(c). If the
Administrator withdraws a chemical substance, mixture, or category of
chemical substances from the amendment, in accordance with 40 CFR
716.105(c), a Federal Register document announcing this decision will
be published no later than February 28, 2008.

V. Materials in the Docket

    The official docket for this final rule has been established under
docket ID number EPA-HQ-OPPT-2007-0487. The official public docket is
available for review as specified in ADDRESSES. The following is a
listing of the documents referenced in this preamble that have been
placed in the official docket for this final rule:
    1. CPSC. Recalls and Product Safety News. Available on-line at:
http://www.cpsc.gov/cpscpub/prerel/prerel.html.

    2. EPA. Toxic Substances Control Act (TSCA) Section 8(e) Notices--
Frequent Questions--September 2006--Health and Safety - Questions 25
and 26. Available on-line at: http://www.epa.gov/oppt/tsca8e/pubs/frequentlyaskedquestionsfaqs.htm#health2
.

    3. EPA. Chemical Information Rules; Additional Automatic Reporting;
Final Rule. Federal Register (50 FR 34809; August 28, 1985).
    4. ITC. Sixtieth Report of the ITC. Federal Register (72 FR 41414,
July 27, 2007) (FRL-8137-6). Available on-line at: http://www.epa.gov/fedrgstr
.

    5. CPSC. Children's Jewelry Containing Lead; Advanced Notice of
Proposed Rulemaking; Request for Comments and Information. Federal
Register (72 FR 920, January 9, 2007).
    6. EPA. TSCA Section 8(d): Economic Impact Analysis for Adding Lead
and Lead Compounds from the 60\th\ Report of the TSCA Interagency
Testing Committee to the Health and Safety Data Reporting rule.
November 14, 2007.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866

    The Office of Management and Budget (OMB) has exempted actions
under TSCA section 8(d) related to the TSCA section 8(d) model rule
from the requirements of Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

    The information collection requirements contained in TSCA section
8(d) model rules have already been approved by OMB under the provisions
of the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and OMB
control number 2070-0004 (EPA ICR No. 0575). The collection activities
in this final rule are captured by the existing approval and do not
require additional review and/or approval by OMB.
    EPA estimates that the information collection activities related to
health and safety data reporting for the category of lead and lead
compounds in this final rule will result in a total

public reporting burden of 14,348 hours, or roughly 4.7 hours per firm.
Of that total, an estimated 6,126 hours are estimated to be spent
performing an initial review of the final rule. The remaining hours are
associated with the actual required reporting activities (Ref. 6). As
defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal Agency. This includes the time needed to: Review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements which have subsequently
changed; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose the information.
    Under PRA, an Agency may not conduct or sponsor, and a person is
not required to respond to, an information collection request unless it
displays a currently valid OMB control number. The OMB control numbers
for EPA's regulations, including its regulations implementing TSCA
section 8(d) at 40 CFR part 716, are listed in the table in 40 CFR part
9 and included on the related collection instrument. This listing of
the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that this final rule
will not have a significant adverse economic impact on a substantial
number of small entities. The factual basis for the Agency's
determination is presented in the small entity impact analysis prepared
as part of the Economic Analysis (Ref. 6) for this final rule, and is
summarized here.
    To estimate the impact of the final rule on a business, EPA used
the ``sales test,'' wherein costs for any individual firm are measured
as a percent of annual sales. The average cost per company for the
final rule is estimated to be $283. At an average cost for any one firm
of $283, the firm's total sales would have to be less than $30,000 for
this final rule to have an impact of even 1% of sales. Because of the
uncertainty regarding the number and identity of the firms who will be
required to respond to this data collection, it is not possible to
directly compare the estimated cost to the actual sales volume of those
firms. But due to the low level of the impact, it is not expected that
this action will have a significant impact on a substantial number of
small entities.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this final rule does
not contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. In addition, EPA has
determined that this final rule will not significantly or uniquely
affect small governments. Accordingly, the final rule is not subject to
the requirements of UMRA sections 202, 203, 204, or 205.

E. Executive Orders 13132 and 13175

    Based on EPA's experience with past TSCA section 8(d) model rules,
State, local, and tribal governments have not been impacted by these
rules, and EPA does not have any reasons to believe that any State,
local, or tribal government will be impacted by this final rule. As a
result, these rules are not subject to the requirements in Executive
Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) or
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000).

F. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April
23,1997), does not apply to this final rule, because it is not
``economically significant'' as defined under Executive Order 12866,
and does not concern an environmental health or safety risk that may
have a disproportionate effect on children. This final rule requires
the reporting of health and safety data to EPA by manufacturers
(including importers) of certain chemicals requested by the ITC to be
added to the TSCA 8(d) model rule in its 60\th\ ITC Report (Ref. 4).

G. Executive Order 13211

    This final rule is not subject to Executive Order 13211, entitled
Actions that Significantly Affect Energy Supply, Distribution, or Use
(66 FR 28355, May 22, 2001), because this action is not expected to
affect energy supply, distribution, or use.

H. National Technology Transfer and Advancement Act

    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note). Section 12(d) of NTTAA directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA directs EPA to provide Congress, through
OMB, explanations when the Agency decides not to use available and
applicable voluntary consensus standards.

I. Executive Order 12898

    This action does not involve special considerations of
environmental justice-related issues pursuant to Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 716

    Environmental protection, Chemicals, Children, Hazardous
substances, Health and safety, Lead, Reporting and recordkeeping
requirements, Toys.

    Dated: January 22, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 716--[AMENDED]

0
1. The authority citation for part 716 continues to read as follows:

    Authority: 15 U.S.C. 2607(d).

0
2. By adding a new paragraph (a)(8) to Sec.  716.21 to read as follows:

Sec.  716.21  Chemical specific reporting requirements.

    (a) * * *
    (8)(i) Reporting requirements apply only to manufacturers
(including importers) of consumer products intended for use by children
who also manufacture (including import) lead or lead compounds. For the
category ``lead and lead compounds,'' all unpublished health and safety
studies that:
    (A) Relate to the lead content of consumer products that are
``intended for use by children'' as that term is defined at 40 CFR
710.43 (excluding children's metal jewelry), or
    (B) Assess children's exposure to lead from such products
(including studies of bioavailability).
    (ii) With regard to purity, studies showing any measurable lead
content in such products must be submitted.
* * * * *

0
3. In Sec.  716.120, the table in paragraph (c) is amended by adding in
alphabetical order the category ``Lead and lead compounds'' and its
entries to read as follows:

Sec.  716.120  Substances and listed mixtures to which this subpart
applies.

* * * * *
    (c) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       CAS No. (examples for
                      Category                               category)            Special exemptions         Effective date            Sunset date
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      * * * * * * *
Lead and lead compounds.............................  .......................      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
                                                              ...............
    Lead............................................                7439-92-1      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Acetic acid, lead (2+) salt.....................                 301-04-2      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Carbonic acid, lead (2+) salt (1:1).............                 598-63-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead chloride (PbCl2)...........................                7758-95-4      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Chromic acid (H2Cr04), lead (2+) salt (1:1).....                7758-97-6      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead oxide (PbO2)...............................                1309-60-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Borate (1-), tetrafluoro-, lead (2+) (2:1)......               13814-96-5      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Phosphoric acid, lead (2+) salt (2:3)...........                7446-27-7      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Silicic acid, lead salt, basic..................               53466-66-3      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Octadecanoic acid, lead salt (1:?)..............                7428-48-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Sulfuric acid, lead salt (1:?), basic...........               63653-42-9      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
    Lead sulfide (PbS)..............................                1314-87-0      Sec.   716.21(a)(8)        February 28, 2008           April 28, 2008
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E8-1546 Filed 1-28-08; 8:45 am]

BILLING CODE 6560-50-S