[Federal Register: December 13, 2005 (Volume 70, Number 238)]
[Rules and Regulations]
[Page 73595-73604]
[DOCID:fr13de05-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 61 and 63

[R06-OAR-2005-OK-0003; FRL-8006-7]

National Emission Standards for Hazardous Air Pollutants;
Delegation of Authority to Oklahoma Department of Environmental Quality

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule; delegation of authority.

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SUMMARY: The Oklahoma Department of Environmental Quality (ODEQ) has
submitted updated regulations for receiving delegation of EPA authority
for implementation and enforcement of National Emission Standards for
Hazardous Air Pollutants (NESHAPs) for all sources. These regulations
apply to certain NESHAPs promulgated by

EPA, as amended through September 1, 2004. The delegation of authority
under this notice applies only to sources located in Oklahoma, and does
not extend to sources located in Indian country. EPA is providing
notice that it is taking direct final action to approve the delegation
of certain NESHAPs to ODEQ.

DATES: This rule is effective on February 13, 2006 without further
notice, unless EPA receives relevant adverse comment by January 12,
2006. If EPA receives such comment, EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.

ADDRESSES: Submit your comments, identified by Regional Materials in
EDocket (RME) ID No. R06-OAR-2005-OK-0003, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Agency Web site: http://docket.epa.gov/rmepub/, Regional

Materials in EDocket (RME), EPA's electronic public docket and comment
system, is EPA's preferred method for receiving comments. Once in the
system, select ``quick search,'' then key in the appropriate RME Docket
identification number. Follow the on-line instructions for submitting
comments.
     U.S. EPA Region 6 ``Contact Us'' Web site: http://epa.gov/region6/r6coment.htm.
 Please click on ``6PD'' (Multimedia) and select

``Air'' before submitting comments.
     E-mail: Jeff Robinson at<EMAIL_ADDRESS>     Fax: Mr. Jeff Robinson, Air Permits Section (6PD-R), at
fax number<PHONE_NUMBER>.
     Mail: Mr. Jeff Robinson, Air Permits Section (6PD-R),
Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas,
Texas 75202-2733.
     Hand or Courier Delivery: Mr. Jeff Robinson, Air Permits
Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only
between the hours of 8 a.m. and 4 p.m. weekdays except for legal
holidays. Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Regional Materials in EDocket
(RME) ID No. R06-OAR-2005-OK-0003. EPA's policy is that all comments
received will be included in the public file without change, change and
may be made available online at http://docket.epa.gov/rmepub/,

including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information the disclosure of which is restricted by
statute. Do not submit information through Regional Material in EDocket
(RME), regulations.gov, or e-mail if you believe that it is CBI or
otherwise protected from disclosure. The EPA RME Web site and the
Federal regulations.gov are ``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 RME or regulations.gov, your e-
mail address will be automatically captured and included as part of the
comment that is placed in the public file 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 electronic docket are listed in the
Regional Materials in EDocket (RME) index at http://docket.epa.gov/rmepub/.
 Although listed in the index, some information is not publicly

available, i.e., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in RME or in the official file which is
available at the Air Permitting Section (6PD-R), Environmental
Protection Agency, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-
2733. The file will be made available by appointment for public
inspection in the Region 6 FOIA Review Room between the hours of 8:30
a.m. and 4:30 p.m. weekdays except for legal holidays. Contact the
person listed in the FOR FURTHER INFORMATION CONTACT paragraph below to
make an appointment. If possible, please make the appointment at least
two working days in advance of your visit. There will be a 15 cent per
page fee for making photocopies of documents. On the day of the visit,
please check in at the EPA Region 6 reception area at 1445 Ross Avenue,
Suite 700, Dallas, Texas.
    The delegation request is also available for public inspection at
the State Air Agency listed below during official business hours by
appointment:
    Oklahoma Department of Environmental Quality, Air Quality Division,
707 North Robinson, Oklahoma City, Oklahoma 73101.

FOR FURTHER INFORMATION CONTACT: Mr. Jeff Robinson, U.S. EPA, Region 6,
Multimedia Planning and Permitting Division (6PD), 1445 Ross Avenue,
Dallas, TX 75202-2733, telephone<PHONE_NUMBER>; fax number 214-665-
7263; or electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

Table of Contents

I. General Information
II. What Does This Action Do?
III. What Is the Authority for Delegation?
IV. What Criteria Must ODEQ Program Meet To Be Approved?
V. How Did ODEQ Meet the Subpart E Approval Criteria?
VI. What Is Being Delegated?
VII. What Is Not Being Delegated?
VIII. How Will Applicability Determinations Under Section 112 Be
Made?
IX. What Authority Does EPA Have?
X. What Information Must ODEQ Provide to EPA?
XI. What Is EPA's Oversight of This Delegation to ODEQ?
XII. Should Sources Submit Notices to EPA Or ODEQ?
XIII. How Will Unchanged Authorities Be Delegated to ODEQ in the
Future?
XIV. Final Action
XV. Statutory and Executive Order Reviews

I. General Information

A. Tips for Preparing Your Comments

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    2. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.

    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

B. Submitting Confidential Business Information (CBI)

    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. What Does This Notice Do?

    EPA is taking direct final action to approve the delegation of
certain NESHAPs to ODEQ. With this delegation, ODEQ has the primary
responsibility to implement and enforce the delegated standards. See
Section VI, below, for a complete discussion of which standards are
being delegated and which are not being delegated.

III. What Is the Authority for Delegation?

    Section 112(l) of the CAA and 40 CFR part 63, subpart E, authorizes
EPA to delegate authority to any state or local agency which submits
adequate regulatory procedures for implementation and enforcement of
emission standards for hazardous air pollutants. The hazardous air
pollutant standards are codified at 40 CFR parts 61 and 63.

IV. What Criteria Must ODEQ's Program Meet To Be Approved?

    EPA previously approved ODEQ's program for the delegation of
NESHAPS in 40 CFR part 61. 47 FR 17285 (April 22, 1982). EPA also
previously approved ODEQ's program for the delegation of certain NESHAP
standards in 40 CFR part 63. 66 FR 1584 (January 9, 2001). Section
112(l) of the CAA enables EPA to approve State air toxics programs or
rules to operate in place of the Federal air toxics program or rules.
40 CFR part 63, subpart E (subpart E) governs EPA's approval of State
rules or programs under Section 112(l).
    EPA will approve an air toxics program if we find that:
    (1) the State program is ``no less stringent'' than the
corresponding Federal program or rule;
    (2) the State has adequate authority and resources to implement the
program;
    (3) the schedule for implementation and compliance is sufficiently
expeditious; and
    (4) the program otherwise complies with Federal guidance.
    In order to obtain approval of its program to implement and enforce
Federal section 112 rules as promulgated without changes (straight
delegation), only the criteria of 40 CFR 63.91(d) must be met. 40 CFR
63.91(d)(3) provides that interim or final Title V program approval
will satisfy the criteria of 40 CFR 63.91(d) for part 70 sources.

V. How Did ODEQ Meet the Subpart E Approval Criteria?

    As part of its Title V submission, ODEQ stated that it intended to
use the mechanism of incorporation by reference to adopt unchanged
Federal section 112 into its regulations. This applied to both existing
and future standards as they applied to part 70 sources. 60 FR 13088-
13095 (March 10, 1995), EPA approved ODEQ's program for receiving
delegation of existing and future standards when it granted final
interim approval to ODEQ's Title V program. 61 FR 4220-4224 (February
5, 1996). EPA granted final approval of Oklahoma's operating Title V
operating permits program on November 30, 2001. 66 FR 63170-63175
(December 5, 2001). Under 40 CFR 63.91(d)(2), once a state or local air
pollution agency has satisfied up-front approval criteria, it needs
only to reference the previous demonstration and reaffirm that it still
meets the criteria for any subsequent submittals. ODEQ has final Title
V program approval and has affirmed that it still meets the up-front
approval criteria.

VI. What Is Being Delegated?

    EPA received a request to update the NESHAP delegations on June 15,
2005. ODEQ requested the EPA to update the delegation of authority for
the following:
    A. NESHAPs (40 CFR Part 61 standards) through September 1, 2004;
and
    B. NESHAPs (40 CFR Part 63 standards) through September 1, 2004.
    ODEQ's request was for delegation of certain NESHAPs for all
sources (both part 70 and non-part 70 sources). The request includes
revisions of OAC 252:100-41-15, as adopted by the Oklahoma Department
of Environmental Quality. For the Part 61 NESHAPs, this revision
included all NESHAPs promulgated by EPA as amended in the Federal
Register through September 1, 2004, excluding Subparts B, H, I, K, Q,
R, T, and W. For the Part 63 NESHAPs, this includes the NESHAPs set
forth in Table 1 below. The effective date of the Federal delegation
for parts 61 and 63 standards is the effective date of this rule.

Table 1.--40 CFR Part 63 NESHAPs for Source Categories Delegated to ODEQ
------------------------------------------------------------------------
         Subpart                          Source category
------------------------------------------------------------------------
A........................  General Provisions.
F........................  Hazardous Organic NESHAP (HON)--Synthetic
                            Organic Chemical Manufacturing Industry
                            (SOCMI).
G........................  HON--SOCMI Process Vents, Storage Vessels,
                            Transfer Operations and Wastewater.
H........................  HON--Equipment Leaks.
I........................  HON--Certain Processes Negotiated Equipment
                            Leak Regulation.
J........................  Polyvinyl Chloride and Copolymers Production
                            .\1\
L........................  Coke Oven Batteries.
M........................  Perchloroethylene Dry Cleaning.
N........................  Chromium Electroplating and Chromium
                            Anodizing Tanks.
O........................  Ethylene Oxide Sterilizers.
Q........................  Industrial Process Cooling Towers.
R........................  Gasoline Distribution.
S........................  Pulp and Paper Industry.
T........................  Halogenated Solvent Cleaning.

U........................  Group I Polymers and Resins.
W........................  Epoxy Resins Production and Non-Nylon
                            Polyamides Production.
X........................  Secondary Lead Smelting.
Y........................  Marine Tank Vessel Loading.
AA.......................  Phosphoric Acid Manufacturing Plants.
BB.......................  Phosphate Fertilizers Production Plants.
CC.......................  Petroleum Refineries.
DD.......................  Off-Site Waste and Recovery Operations.
EE.......................  Magnetic Tape Manufacturing.
GG.......................  Aerospace Manufacturing and Rework
                            Facilities.
HH.......................  Oil and Natural Gas Production Facilities.
II.......................  Shipbuilding and Ship Repair Facilities.
JJ.......................  Wood Furniture Manufacturing Operations.
KK.......................  Printing and Publishing Industry.
LL.......................  Primary Aluminum Reduction Plants.
MM.......................  Chemical Recovery Combustion Sources at
                            Kraft, Soda, Sulfide, and Stand-Alone
                            Semichemical Pulp Mills.
OO.......................  Tanks--Level 1.
PP.......................  Containers.
QQ.......................  Surface Impoundments.
RR.......................  Individual Drain Systems.
SS.......................  Closed Vent Systems, Control Devices,
                            Recovery Devices and Routing to a Fuel Gas
                            System or a Process.
TT.......................  Equipment Leaks--Control Level 1.
UU.......................  Equipment Leaks--Control Level 2 Standards.
VV.......................  Oil-Water Separators and Organic-Water
                            Separators.
WW.......................  Storage Vessels (Tanks)--Control Level 2.
YY.......................  Generic Maximum Achievable Control Technology
                            Standards.
CCC......................  Steel Pickling--HCl Process Facilities and
                            Hydrochloric Acid Regeneration Plants.
DDD......................  Mineral Wool Production.
EEE......................  Hazardous Waste Combustors.
GGG......................  Pharmaceuticals Production.
HHH......................  Natural Gas Transmission and Storage
                            Facilities.
III......................  Flexible Polyurethane Foam Production.
JJJ......................  Group IV Polymers and Resins.
LLL......................  Portland Cement Manufacturing.
MMM......................  Pesticide Active Ingredient Production.
NNN......................  Wool Fiberglass Manufacturing.
OOO......................  Amino/Phenolic Resins.
PPP......................  Polyether Polyols Production.
QQQ......................  Primary Copper Smelting.
RRR......................  Secondary Aluminum Production.
TTT......................  Primary Lead Smelting.
UUU......................  Petroleum Refineries--Catalytic Cracking
                            Units, Catalytic Reforming Units and Sulfur
                            Recovery Plants.
VVV......................  Publicly Owned Treatment Works (POTW).
XXX......................  Ferroalloys Production: Ferromanganese and
                            Silicomanganese.
AAAA.....................  Municipal Solid Waste Landfills.
CCCC.....................  Nutritional Yeast Manufacturing.
DDDD.....................  Plywood and Composite Wood Products.
EEEE.....................  Organic Liquid Distribution.
FFFF.....................  Miscellaneous Organic Chemical Manufacturing.
GGGG.....................  Solvent Extraction for Vegetable Oil
                            Production.
HHHH.....................  Wet Formed Fiberglass Mat Production.
IIII.....................  Auto & Light Duty Truck.
JJJJ.....................  Paper & Other Web Coating.
KKKK.....................  Surface Coating of Metal Cans.
MMMM.....................  Surface Coating of Miscellaneous Metal Parts
                            and Products.
NNNN.....................  Surface Coating of Large Appliances.
OOOO.....................  Printing, Coating, and Dyeing of Fabrics and
                            Other Textiles.
PPPP.....................  Plastic Parts.
QQQQ.....................  Surface Coating of Wood Building Products.
RRRR.....................  Surface Coating of Metal Furniture.
SSSS.....................  Surface Coating of Metal Coil.
TTTT.....................  Leather Finishing Operations.
UUUU.....................  Cellulose Production Manufacture.
VVVV.....................  Boat Manufacturing.
Whttp://WWW.....................  Reinforced Plastic Composites Production.

XXXX.....................  Tire Manufacturing.
YYYY.....................  Stationary Combustion Turbines.
ZZZZ.....................  Reciprocating Internal Combustion Engines.
AAAAA....................  Lime Manufacturing Plants.
BBBBB....................  Semiconductor Manufacturing.
CCCCC....................  Coke Ovens: Pushing, Quenching and Battery
                            Stacks.
EEEEE....................  Iron and Steel Foundries.

FFFFF....................  Integrated Iron and Steel.
GGGGG....................  Site Remediation.
HHHHH....................  Miscellaneous Coating Manufacturing.
IIIII....................  Mercury Cell Chlor-Alkali Plants.
JJJJJ....................  Brick and Structural Clay Products.
KKKKK....................  Clay Ceramics Manufacturing.
LLLLL....................  Asphalt Roofing and Processing.
MMMMM....................  Flexible Polyurethane Foam Fabrication
                            Operation.
NNNNN....................  Hydrochloric Acid Production.
PPPPP....................  Engine Test Cells/Stands.
QQQQQ....................  Friction Products Manufacturing.
RRRRR....................  Taconite Iron Ore Processing.
SSSSS....................  Refractory Products Manufacturing.
TTTTT....................  Primary Magnesium Refining.
------------------------------------------------------------------------
\1\ The ODEQ has adopted the subpart unchanged and applied for
  delegation of the standard. The standard was vacated and remanded to
  EPA by the United States Court of Appeals for the District of Columbia
  Circuit. See, Mossville Environmental Action Network v. EPA, 370 F. 3d
  1232 (DC Cir. 2004). Because of the DC Circuit Court's holding this
  standard is not being delegated to ODEQ at this time.

VII. What Is Not Being Delegated?

    As mentioned above, ODEQ has not been delegated the authority for
the following standards:

40 CFR Part 60, Subpart AAA (Standards of Performance for New
Residential Wood Heaters);
40 CFR Part 60, Subpart WWW, (Standards of Performance for Municipal
Solid Waste Landfills);
40 CFR Part 60, Subpart Cc, (Emission Guidelines and Compliance Times
for Municipal Solid Waste Landfills);
40 CFR Part 61, Subpart B (National Emission Standards for Radon
Emissions from Underground Uranium Mines);
40 CFR Part 61, Subpart H (National Emission Standards for Emissions of
Radionuclides Other Than Radon From Department of Energy Facilities);
40 CFR Part 61, Subpart I (National Emission Standards for Radionuclide
Emissions from Federal Facilities Other Than Nuclear Regulatory
Commission Licensees and Not Covered by Subpart H);
40 CFR Part 61, Subpart K--(National Emission Standards for
Radionuclide Emissions from Elemental Phosphorus Plants);
40 CFR Part 61, Subpart Q (National Emission Standards for Radon
Emissions from Department of Energy facilities);
40 CFR Part 61, Subpart R (National Emission Standards for Radon
Emissions from Phosphogypsum Stacks);
40 CFR Part 61, Subpart T (National Emission Standards for Radon
Emissions from the Disposal of Uranium Mill Tailings); and
40 CFR Part 61, Subpart W (National Emission Standards for Radon
Emissions from Operating Mill Tailings).

    In addition, EPA cannot delegate to a State any of the Category II
Subpart A authorities set forth in 40 CFR 63.91(g)(2). These include
the following provisions: Sec.  63.6(g), Approval of Alternative Non-
Opacity Standards; Sec.  63.6(h)(9), Approval of Alternative Opacity
Standards; Sec.  63.7(e)(2)(ii) and (f), Approval of Major Alternatives
to Test Methods; Sec.  63.8(f), Approval of Major Alternatives to
Monitoring; and Sec.  63.10(f), Approval of Major Alternatives to
Recordkeeping and Reporting. Also, some MACT standards have certain
provisions that cannot be delegated to the States (e.g. 40 CFR
63.106(b)). Therefore, any MACT standard that EPA is delegating to ODEQ
that provides that certain authorities cannot be delegated are retained
by EPA and not delegated. Furthermore, no authorities are delegated
that require rulemaking in the Federal Register to implement, or where
Federal overview is the only way to ensure national consistency in the
application of the standards or requirements of CAA Section 112.
Finally, Section 112(r), the accidental release program authority, is
not being delegated by this approval.
    All of the inquiries and requests concerning implementation and
enforcement of the excluded standards in the State of Oklahoma should
be directed to the EPA Region 6 Office.
    This delegation to ODEQ to implement and enforce certain NESHAPs
does not extend to sources or activities located in Indian country, as
defined in 18 U.S.C. 1151. Under this definition, EPA treats as
reservations, trust lands validly set aside for the use of a Tribe even
if the trust lands have not been formally designated as a reservation.
Consistent with previous Federal program approvals or delegations, EPA
will continue to implement the NESHAPs in Indian country because ODEQ
has not adequately demonstrated its authority over sources and
activities located within the exterior boundaries of Indian
reservations and other areas in Indian country.\2\
---------------------------------------------------------------------------

    \2\ The Safe, Accountable, Flexible, Efficient Transportation
Equity Act of 2005 includes a provision relating to Oklahoma and EPA
programs, providing:
    Notwithstanding any other provision of law, if the Administrator
of the Environmental Protection Agency (referred to in this section
as the ``Administrator'') determines that a regulatory program
submitted by the State of Oklahoma for approval by the Administrator
under a law administered by the Administrator meets applicable
requirements of the law, and the Administrator approves the State to
administer the State program under the law with respect to areas in
the State that are not Indian country, on request of the State, the
Administrator shall approve the State to administer the State
program in the areas of the State that are in Indian country,
without any further demonstration of authority by the State.
    H.R. 3, Section 10211(a). Oklahoma has not applied to administer
the NESHAPS program in Indian country in accordance with this
statute.
---------------------------------------------------------------------------

VIII. How Will Applicability Determinations Under Section 112 Be Made?

    In approving this delegation, ODEQ will obtain concurrence from EPA
on any matter involving the interpretation of section 112 of the CAA or
40 CFR part 63 to the extent that implementation, administration, or
enforcement of these sections have not been covered by EPA
determinations or guidance.

IX. What Authority Does EPA Have?

    We retain the right, as provided by CAA section 112(l)(7), to
enforce any applicable emission standard or requirement under Section
112. EPA

also has the authority to make certain decisions under the General
Provisions (subpart A) of part 63. We are granting ODEQ some of these
authorities, and retaining others, as explained in Sections VI and VII
above. In addition, EPA may review and disapprove of State
determinations and subsequently require corrections. (See 40 CFR
63.91(g) and 65 FR 55810, 55823, September 14, 2000.)
    Furthermore, we retain any authority in an individual emission
standard that may not be delegated according to provisions of the
standard. Also, listed in the footnotes of the part 63 delegation table
at the end of this rule are the authorities that cannot be delegated to
any State or local agency which we therefore retain.

X. What Information Must ODEQ Provide to EPA?

    In delegating the authority to implement and enforce these rules
and in granting a waiver of EPA notification requirements, we require
ODEQ to input all source information into the Aerometric Information
Retrieval System (AIRS) for both point and area sources. ODEQ must
enter this information into the AIRS system and update the information
by September 30 of every year. ODEQ must provide any additional
compliance related information to EPA, Region 6, Office of Enforcement
and Compliance Assurance within 45 days of a request under 40 CFR
63.96(a).
    In receiving delegation for specific General Provisions
authorities, ODEQ must submit to EPA Region 6 on a semi-annual basis,
copies of determinations issued under these authorities. For part 63
standards, these determinations include: Applicability determinations
(Sec.  63.1); approval/disapprovals of construction and reconstruction
(Sec.  63.5(e) and (f)); notifications regarding the use of a
continuous opacity monitoring system (Sec.  63.6(h)(7)(ii)); finding of
compliance (Sec.  63.6(h)(8)); approval/disapprovals of compliance
extensions (Sec.  63.6(i)); approvals/disapprovals of minor (Sec.
63.7(e)(2)(i)) or intermediate (Sec.  63.7(e)(2)(ii) and (f))
alternative test methods; approval of shorter sampling times and
volumes (Sec.  63.7(e)(2)(iii)); waiver of performance testing (Sec.
63.7(e)(2)(iv) and (h)(2), (3)); approvals/disapprovals of minor or
intermediate alternative monitoring methods (Sec.  63.8(f)); approval
of adjustments to time periods for submitting reports (Sec. Sec.  63.9
and 63.10); and approvals/disapprovals of minor alternatives to
recordkeeping and reporting (Sec.  63.10(f)).
    Additionally, EPA's Emission Measurement Center of the Emissions
Monitoring and Analysis Division must receive copies of any approved
intermediate changes to test methods or monitoring. (Please note that
intermediate changes to test methods must be demonstrated as equivalent
through the procedures set out in EPA method 301.) This information on
approved intermediate changes to test methods and monitoring will be
used to compile a database of decisions that will be accessible to
State and local agencies and EPA Regions for reference in making future
decisions. (For definitions of major, intermediate and minor
alternative test methods or monitoring methods, see 40 CFR 63.90). The
ODEQ should forward these intermediate test methods or monitoring
changes via mail or facsimile to: Chief, Source Categorization Group A,
EPA (MD-19), Research Triangle Park, NC 27711, Facsimile telephone
number:<PHONE_NUMBER>.

XI. What Is EPA's Oversight of This Delegation to ODEQ?

    EPA must oversee ODEQ's decisions to ensure the delegated
authorities are being adequately implemented and enforced. We will
integrate oversight of the delegated authorities into the existing
mechanisms and resources for oversight currently in place. If, during
oversight, we determine that ODEQ made decisions that decreased the
stringency of the delegated standards, then ODEQ shall be required to
take corrective actions and the source(s) affected by the decisions
will be notified, as required by 40 CFR 63.91(g)(1)(ii). We will
initiate withdrawal of the program or rule if the corrective actions
taken are insufficient.

XII. Should Sources Submit Notices to EPA or ODEQ?

    All of the information required pursuant to the Federal NESHAP (40
CFR parts 61 and 63) should be submitted by sources located outside of
Indian country directly to the ODEQ at the following address: Oklahoma
Department of Environmental Quality, Air Quality Division, P.O. Box
1677, Oklahoma City, OK 73101-1677. The ODEQ is the primary point of
contact with respect to delegated NESHAPs in Oklahoma (excluding Indian
country). Sources do not need to send a copy to EPA. EPA Region 6
waives the requirement that notifications and reports for delegated
standards be submitted to EPA in addition to ODEQ in accordance with 40
CFR 63.9(a)(4)(ii) and 63.10(a)(4)(ii).

XIII. How Will Unchanged Authorities Be Delegated to ODEQ in the
Future?

    In the future, ODEQ will only need to send a letter of request to
EPA, Region 6, for those NSPS and NESHAP regulations that ODEQ has
adopted by reference. The letter must reference the previous up-front
approval demonstration and reaffirm that it still meets the up-front
approval criteria. We will respond in writing to the request stating
that the request for delegation is either granted or denied. A Federal
Register notice will be published to inform the public and affected
sources of the delegation, indicating where source notifications and
reports should be sent, and to amend the relevant portions of the Code
of Federal Regulations showing which NESHAP standards have been
delegated to ODEQ.

XIV. Final Action

    The public was provided the opportunity to comment on the proposed
approval of the program and mechanism for delegation of Section 112
standards, as applied to part 70 sources, on March 10, 1995. The
proposal was part of EPA's proposed approval of the Oklahoma Department
of Environmental Quality's operating permits program. 60 FR 13088. The
EPA did not receive adverse public comments on the proposed delegation
of Section 112 standards. 61 FR 4220 (February 5, 1996). In this
action, the public is given the opportunity to comment on the approval
of ODEQ's request for delegation of authority to implement and enforce
certain Section 112 standards for all sources (both part 70 and non-
part 70 sources) which have been adopted by reference into Oklahoma's
state regulations. However, the Agency views the approval of these
requests as a noncontroversial action and anticipates no adverse
comments. Therefore, EPA is publishing this rule without prior
proposal. However, in the ``Proposed Rules'' section of today's Federal
Register publication, EPA is publishing a separate document that will
serve as the proposal to approve the program and delegation of
authority described in this action if adverse comments are received.
This action will be effective February 13, 2006 without further notice
unless the Agency receives relevant adverse comments by January 12,
2006.
    If EPA receives adverse comments, we will publish a timely
withdrawal in the Federal Register informing the public the rule will
not take effect. We will address all public comments in a subsequent
final rule based on the proposed rule. The EPA will not

institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
we receive adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, we may adopt as final those provisions of the rule that are
not the subject of an adverse comment.

XVI. Statutory and Executive Order Reviews

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, ``Regulatory Planning and
Review.'' (58 FR 51735 (October 4, 1993)). This proposed rule is not a
``significant energy action'' as defined in Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355 (May 22, 2001)), because it
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy. This proposed action merely proposes to
approve state law as meeting Federal requirements and imposes no
additional requirements beyond those imposed by state law. Accordingly,
the Administrator certifies that this proposed rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule proposes to approve pre-existing requirements under state law
and does not impose any additional enforceable duty beyond that
required by state law, EPA has determined that this rule does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, or tribal governments in the
aggregate, or on the private sector, in any one year. Thus, today's
rule is not subject to the requirements of sections 202 and 205 of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In
addition, EPA has determined that this rule contains no regulatory
requirements that might significantly or uniquely affect small
governments in accordance with section 203 of UMRA.
    This proposed rule also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the 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, ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, (November 9, 2000)). This action also does
not have federalism implications because it does not have substantial
direct effects 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, as specified
in Executive Order 13132, ``Federalism'' (64 FR 43255, (August 10,
1999)). This action merely proposes to approve a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This proposed rule also is not subject to Executive Order
13045, ``Protection of Children from Environmental Health Risks and
Safety Risks'' (62 FR 19885, (April 23, 1997)). EPA interprets
Executive Order 13045 as applying only to those regulatory actions that
are based on health or safety risks, such that the analysis required
under section 5-501 of the Order has the potential to influence the
regulation. This proposed rule is not subject to Executive Order 13045
because it approves a state program.
    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 (15 U.S.C. 272 note) requires Federal agencies to
evaluate existing technical standards when developing a new regulation.
To comply with NTTAA, EPA must consider and use ``voluntary consensus
standards'' (VCS) if available and applicable when developing programs
and policies unless doing so would be inconsistent with applicable law
or otherwise impractical. In this context, in the absence of a prior
existing requirement for the State to use voluntary consensus standards
(VCS), EPA has no authority to disapprove a delegation submission for
failure to use VCS. It would thus be inconsistent with applicable law
for EPA to use VCS in place of a delegation submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    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.
804(2).
    Under Section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 13, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action may not be challenged later in proceedings
to enforce its requirements. (See section 307(b)(2)).

List of Subjects

40 CFR Part 61

    Environmental protection, Air pollution control, Hazardous
substances, Reporting and recordkeeping requirements.

40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of Sections
111 and 112 of the Clean Air Act, as amended, 42 U.S.C. 7411 and
7412.

    Dated: November 29, 2005.
Carl E. Edlund,
Acting Regional Administrator, Region 6.

0
40 CFR parts 61 and 63 are amended as follows:

PART 61--[AMENDED]

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

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

Subpart A--General Provisions

0
2. Section 61.04 is amended by:
0
A. Revising paragraph (b)(LL) introductory text; and
0
B. Revising paragraph (c)(6)(iv) and reserving paragraph (c)(6)(v) to
read as follows:

Sec.  61.04  Address.

    (b) * * *

    (LL) State of Oklahoma, Oklahoma Department of Environmental
Quality, Air Quality Division, P.O. Box 1677, Oklahoma City, OK 73101-
1677. For a list of delegated standards for Oklahoma (excluding Indian
country), see paragraph (c)(6) of this section.
* * * * *
    (c) * * *
    (6) * * *
* * * * *
    (iv) The Oklahoma Department of Environmental Quality has been
delegated the following part 61 standards promulgated by EPA, as
amended in the Federal Register through September 1, 2004. The (X)
symbol is used to indicate each subpart that has been delegated.

   Delegation Status for National Emission Standards for Hazardous Air
 Pollutants (Part 61 Standards) for Oklahoma Department of Environmental
                                 Quality
                     [Excluding Indian Country] \1\
------------------------------------------------------------------------
            Subpart                     Source category           ODEQ
------------------------------------------------------------------------
A.............................  General Provisions............        X
B.............................  Radon Emissions From            ........
                                 Underground Uranium Mines.
C.............................  Beryllium.....................        X
D.............................  Beryllium Rocket Motor Firing.        X
E.............................  Mercury.......................        X
F.............................  Vinyl Chloride................        X
G.............................  (Reserved)....................  ........
H.............................  Emissions of Radionuclides      ........
                                 Other Than Radon From
                                 Department of Energy
                                 Facilities.
I.............................  Radionuclide Emissions From     ........
                                 Federal Facilities Other Than
                                 Nuclear Regulatory Commission
                                 Licensees and Not Covered by
                                 Subpart H.
J.............................  Equipment Leaks (Fugitive             X
                                 Emission Sources) of Benzene.
K.............................  Radionuclide Emissions From     ........
                                 Elemental Phosphorus Plants.
L.............................  Benzene Emissions From Coke By-       X
                                 Product Recovery Plants.
M.............................  Asbestos......................        X
N.............................  Inorganic Arsenic Emissions           X
                                 From Glass Manufacturing
                                 Plants.
O.............................  Inorganic Arsenic Emissions           X
                                 From Primary Copper Smelters.
P.............................  Inorganic Arsenic Emissions           X
                                 From Arsenic Trioxide and
                                 Metallic Arsenic Production
                                 Facilities.
Q.............................  Radon Emissions From            ........
                                 Department of Energy
                                 Facilities.
R.............................  Radon Emissions From            ........
                                 Phosphogypsum Stacks.
S.............................  (Reserved)....................  ........
T.............................  Radon Emissions From the        ........
                                 Disposal of Uranium Mill
                                 Tailings.
U.............................  (Reserved)....................  ........
V.............................  Equipment Leaks (Fugitive             X
                                 Emission Sources).
W.............................  Radon Emissions From Operating  ........
                                 Mill Tailings.
X.............................  (Reserved)....................  ........
Y.............................  Benzene Emissions From Benzene        X
                                 Storage Vessels.
Z-AA..........................  (Reserved)....................  ........
BB............................  Benzene Emissions From Benzene        X
                                 Transfer Operations.
CC-EE.........................  (Reserved)....................  ........
FF............................  Benzene Waste Operations......       X
------------------------------------------------------------------------
\1\ Program delegated to Oklahoma Department of Environmental Quality
  (ODEQ).

    (v) [Reserved.]
* * * * *

PART 63--[AMENDED]

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

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

Subpart E--Approval of State Programs and Delegation of Federal
Authorities

0
2. Section 63.99 is amended by revising paragraph (a)(36)(i) to read as
follows:

Sec.  63.99  Delegated Federal authorities.

    (a) * * *
    (36) * * *
    (i) The following table lists the specific part 63 standards that
have been delegated unchanged to the Oklahoma Department of
Environmental Quality for all sources. The ``X'' symbol is used to
indicate each subpart that has been delegated. The delegations are
subject to all of the conditions and limitations set forth in Federal
law, regulations, policy, guidance, and determinations. Some
authorities cannot be delegated and are retained by EPA. These include
certain General Provisions authorities and specific parts of some
standards. Any amendments made to these rules after this effective date
are not delegated.

       Delegation Status for Part 63 Standards--State of Oklahoma
                       [Excluding Indian Country]
------------------------------------------------------------------------
                                                                  Order
            Subpart                     Source category          \1\ \2\
------------------------------------------------------------------------
A.............................  General Provisions \2\........        X
F.............................  Hazardous Organic NESHAP              X
                                 (HON)--Synthetic Organic
                                 Chemical Manufacturing
                                 Industry (SOCMI).
G.............................  HON--SOCMI Process Vents,             X
                                 Storage Vessels, Transfer
                                 Operations and Wastewater.
H.............................  HON--Equipment Leaks..........        X
I.............................  HON--Certain Processes                X
                                 Negotiated Equipment Leak
                                 Regulation.
J.............................  Polyvinyl Chloride and            (\3\)
                                 Copolymers Production.
K.............................  (Reserved)....................  ........
L.............................  Coke Oven Batteries...........        X
M.............................  Perchloroethylene Dry Cleaning        X
N.............................  Chromium Electroplating and           X
                                 Chromium Anodizing Tanks.
O.............................  Ethylene Oxide Sterilizers....        X
P.............................  (Reserved)....................  ........
Q.............................  Industrial Process Cooling            X
                                 Towers.
R.............................  Gasoline Distribution.........        X
S.............................  Pulp and Paper Industry.......        X
T.............................  Halogenated Solvent Cleaning..        X
U.............................  Group I Polymers and Resins...        X
V.............................  (Reserved)....................  ........
W.............................  Epoxy Resins Production and           X
                                 Non-Nylon Polyamides
                                 Production.
X.............................  Secondary Lead Smelting.......        X
Y.............................  Marine Tank Vessel Loading....        X
Z.............................  (Reserved)....................  ........
AA............................  Phosphoric Acid Manufacturing         X
                                 Plants.
BB............................  Phosphate Fertilizers                 X
                                 Production Plants.
CC............................  Petroleum Refineries..........        X
DD............................  Off-Site Waste and Recovery           X
                                 Operations.
EE............................  Magnetic Tape Manufacturing...        X
FF............................  (Reserved)....................  ........
GG............................  Aerospace Manufacturing and           X
                                 Rework Facilities.
HH............................  Oil and Natural Gas Production        X
                                 Facilities.
II............................  Shipbuilding and Ship Repair          X
                                 Facilities.
JJ............................  Wood Furniture Manufacturing          X
                                 Operations.
KK............................  Printing and Publishing               X
                                 Industry.
LL............................  Primary Aluminum Reduction            X
                                 Plants.
MM............................  Chemical Recovery Combustion          X
                                 Sources at Kraft, Soda,
                                 Sulfide, and Stand-Alone
                                 Semichemical Pulp Mills.
NN............................  (Reserved)....................  ........
OO............................  Tanks--Level 1................        X
PP............................  Containers....................        X
QQ............................  Surface Impoundments..........        X
RR............................  Individual Drain Systems......        X
SS............................  Closed Vent Systems, Control          X
                                 Devices, Recovery Devices and
                                 Routing to a Fuel Gas System
                                 or a Process.
TT............................  Equipment Leaks--Control Level        X
                                 1.
UU............................  Equipment Leaks--Control Level        X
                                 2 Standards.
VV............................  Oil-Water Separators and              X
                                 Organic-Water Separators.
WW............................  Storage Vessels (Tanks)--             X
                                 Control Level 2.
XX............................  (Reserved)....................  ........
YY............................  Generic Maximum Achievable            X
                                 Control Technology Standards.
ZZ-BBB........................  (Reserved)....................  ........
CCC...........................  Steel Pickling--HCl Process           X
                                 Facilities and Hydrochloric
                                 Acid Regeneration.
DDD...........................  Mineral Wool Production.......        X
EEE...........................  Hazardous Waste Combustors....        X
FFF...........................  (Reserved)....................  ........
GGG...........................  Pharmaceuticals Production....        X
HHH...........................  Natural Gas Transmission and          X
                                 Storage Facilities.
III...........................  Flexible Polyurethane Foam            X
                                 Production.
JJJ...........................  Group IV Polymers and Resins..        X
KKK...........................  (Reserved)....................  ........
LLL...........................  Portland Cement Manufacturing.        X
MMM...........................  Pesticide Active Ingredient           X
                                 Production.
NNN...........................  Wool Fiberglass Manufacturing.        X
OOO...........................  Amino/Phenolic Resins.........        X
PPP...........................  Polyether Polyols Production..        X
QQQ...........................  Primary Copper Smelting.......        X
RRR...........................  Secondary Aluminum Production.        X
SSS...........................  (Reserved)....................  ........
TTT...........................  Primary Lead Smelting.........        X
UUU...........................  Petroleum Refineries--                X
                                 Catalytic Cracking Units,
                                 Catalytic Reforming Units and
                                 Sulfur Recovery Plants.
VVV...........................  Publicly Owned Treatment Works        X
                                 (POTW).
http://WWW...........................  (Reserved)....................  ........

XXX...........................  Ferroalloys Production:               X
                                 Ferromanganese and
                                 Silicomanganese.
AAAA..........................  Municipal Solid Waste                 X
                                 Landfills.

CCCC..........................  Nutritional Yeast                     X
                                 Manufacturing.
DDDD..........................  Plywood and Composite Wood            X
                                 Products.
EEEE..........................  Organic Liquids Distribution..        X
FFFF..........................  Miscellaneous Organic Chemical        X
                                 Production and Processes
                                 (MON).
GGGG..........................  Solvent Extraction for                X
                                 Vegetable Oil Production.
HHHH..........................  Wet Formed Fiberglass Mat             X
                                 Production.
IIII..........................  Auto & Light Duty Truck.......        X
JJJJ..........................  Paper and other Web (Surface          X
                                 Coating).
KKKK..........................  Metal Can (Surface Coating)...        X
MMMM..........................  Surface Coating of                    X
                                 Miscellaneous Metal Parts and
                                 Products.
NNNN..........................  Surface Coating of Large              X
                                 Appliances.
OOOO..........................  Fabric Printing Coating and           X
                                 Dyeing.
PPPP..........................  Plastic Parts (Surface                X
                                 Coating).
QQQQ..........................  Surface Coating of Wood               X
                                 Building Products.
RRRR..........................  Surface Coating of Metal              X
                                 Furniture.
SSSS..........................  Surface Coating for Metal Coil        X
TTTT..........................  Leather Finishing Operations..        X
UUUU..........................  Cellulose Production                  X
                                 Manufacture.
VVVV..........................  Boat Manufacturing............        X
Whttp://WWW..........................  Reinforced Plastic Composites         X

                                 Production.
XXXX..........................  Tire Manufacturing............        X
YYYY..........................  Combustion Turbines...........        X
ZZZZ..........................  Reciprocating Internal                X
                                 Combustion Engines (RICE).
AAAAA.........................  Lime Manufacturing Plants.....        X
BBBBB.........................  Semiconductor Manufacturing...        X
CCCCC.........................  Coke Ovens: Pushing, Quenching        X
                                 and Battery Stacks.
DDDDD.........................  Industrial/Commerical/          ........
                                 Institutional Boilers and
                                 Process Heaters.
EEEEE.........................  Iron Foundries................        X
FFFFF.........................  Integrated Iron and Steel.....        X
GGGGG.........................  Site Remediation..............        X
HHHHH.........................  Miscellaneous Coating                 X
                                 Manufacturing.
IIIII.........................  Mercury Cell Chlor-Alkali             X
                                 Plants.
JJJJJ.........................  Brick and Structural Clay             X
                                 Products Manufacturing.
KKKKK.........................  Clay Ceramics Manufacturing...        X
LLLLL.........................  Asphalt Roofing and Processing        X
MMMMM.........................  Flexible Polyurethane Foam            X
                                 Fabrication Operation.
NNNNN.........................  Hydrochloric Acid Production,         X
                                 Fumed Silica Production.
PPPPP.........................  Engine Test Facilities........        X
QQQQQ.........................  Friction Products                     X
                                 Manufacturing.
RRRRR.........................  Taconite Iron Ore Processing..        X
SSSSS.........................  Refractory Products                   X
                                 Manufacture.
TTTTT.........................  Primary Magnesium Refining....       X
------------------------------------------------------------------------
\1\ Program delegated to Oklahoma Department of Environmental Quality
  (ODEQ), as amended in the Federal Register through September 1, 2004.
\2\ Authorities that cannot be delegated include Sec.   63.6(g),
  Approval of Alternative Non-Opacity Standards; Sec.   63.6(h)(9),
  Approval of Alternative Opacity Standards; Sec.   63.7(e)(2)(ii) and
  (f), Approval of Major Alternatives to Test Methods; Sec.   63.8(f),
  Approval of Major Alternatives to Monitoring; and Sec.   63.10(f),
  Approval of Major Alternatives to Recordkeeping and Reporting. In
  addition, all authorities identified in the certain subparts that EPA
  has designated that cannot be delegated.
\3\ The ODEQ has adopted the subpart unchanged and applied for
  delegation of the standard. The standard was vacated and remanded to
  EPA by the United States Court of Appeals for the District of Columbia
  Circuit. See, Mossville Environmental Action Network v. EPA, 370 F. 3d
  1232 (D.C. Cir. 2004). Because of the D.C. Circuit Court's holding
  this standard is not being delegated to ODEQ at this time.

[FR Doc. 05-23970 Filed 12-12-05; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: July 15, 2008 (Volume 73, Number 136)]
[Notices]
[Page 40583-40584]
[DOCID:fr15jy08-55]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0356]

Global Harmonization Task Force, Study Groups 1 and 3; Proposed
and Final Documents; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of final and proposed documents that have been prepared by
Study Groups 1 and 3 of the Global Harmonization Task Force (GHTF),
respectively. These documents represent a harmonized proposal and
recommendation from the GHTF Study Groups that may be used by
governments developing and updating their regulatory requirements for
medical devices. These documents are intended to provide information
only and do not describe FDA's current regulatory requirements;
elements of these documents may not be consistent with current U.S.
regulatory requirements. In particular, FDA seeks comments on the
advantages and disadvantages of the approaches in the GHTF documents,
particularly where they are not consistent with current practices for
the manufacturer of products distributed within the United States.

DATES:  Submit written or electronic comments on these documents by
October 14, 2008. After October 14, 2008, written comments or
electronic comments may be submitted at any time to the contact persons
listed in this document.

ADDRESSES:  Submit written requests for single copies of these
documents to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
Supplementary Information section for information on electronic access
to the documents.
    Submit written comments concerning these documents to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.reguations.gov. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For information regarding Study Group
1: Ginette Y. Michaud, Chairperson, GHTF, Study Group 1, Office of
Device Evaluation, Center for Devices and Radiological Health (HFZ-
480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850,<PHONE_NUMBER>.
    For information regarding Study Group 3: Kimberly Trautman, GHTF,
Study Group 3, Office of Compliance, Center for Devices and
Radiological Health (HFZ-340), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has participated in a number of activities to promote the
international harmonization of regulatory requirements. In September
1992, a meeting was held in Nice, France by senior regulatory officials
to evaluate international harmonization. This meeting led to the
development of the organization now known as the GHTF to facilitate
harmonization. Subsequent meetings have been held in various locations
throughout the world.
    The GHTF is a voluntary group of representatives from national
medical device regulatory authorities and the regulated industry. Since
its inception, the GHTF has been comprised of representatives from five
founding members grouped into three geographical areas: Europe, Asia-
Pacific, and North America, each of which actively regulates medical
devices using their own unique regulatory framework.
    The objective of the GHTF is to encourage convergence at the global

level of regulatory systems of medical devices to facilitate trade
while preserving the right of participating members to address the
protection of public health by regulatory means considered most
suitable. One of the ways this objective is achieved is by identifying
and developing areas of international cooperation to facilitate
progressive reduction of technical and regulatory differences in
systems established to regulate medical devices. In an effort to
accomplish these objectives, the GHTF formed five study groups to draft
documents and carry on other activities designed to facilitate global
harmonization. This notice relates to documents that have been
developed by two of the Study Groups (1 and 3).
    Study Group 1 was initially tasked with the responsibility of
identifying differences between various regulatory systems. In 1995,
the group was asked to propose areas of potential harmonization for
premarket device regulations and possible guidelines that could help
lead to harmonization. As a result of its efforts, this group has
developed final document GHTF/SG1/N011:2008. GHTF/SG1/N011:2008
``Summary Technical Documentation for Demonstrating Conformity to the
Essential Principles of Safety and Performance of Medical Devices
(STED)'' is intended to provide information on the content of the STED
to be assembled and submitted to a Regulatory Authority (RA) or
Conformity Assessment Body (CAB) for premarket review, and for use
postmarket to assess continuing conformity to GHTF Study Group 1's
document, GHTF/SG1/N41R9:2005, ``Essential Principles of Safety and
Performance.''
    Study Group 3 was initially tasked with the responsibility of
developing documents on Quality Systems. As a result of their efforts,
this group has developed proposed document SG3(PD)N17R7. The proposed
document SG3(PD)N17R7 entitled, ``Quality Management System--Medical
Devices--Guidance on the Control of Products and Services Obtained From
Suppliers'' provides information for medical device manufacturers on
control of products and services obtained from suppliers.

II. Significance of Documents

    These documents represent recommendations from the GHTF study
groups and do not describe regulatory requirements. FDA is making these
documents available so that industry and other members of the public
may express their views and opinions. In particular, FDA seeks comments
on the advantages and disadvantages of the approaches in the GHTF
documents, particular where they are not consistent with current
practices for the manufacturer of products distributed in the United
States.

III. Electronic Access

    Persons interested in obtaining a copy of these documents may do so
by using the Internet. The Center for Devices and Radiological Health
(CDRH) maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. Information on the GHTF may be accessed at http://
www.ghtf.org. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh.

IV. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding these
documents. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: July 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16000 Filed 7-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Notices]
[Pages 19915-19918]
[FR Doc No: 2022-07282]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-41-000]

Cameron LNG, LLC; Notice of Scoping Period Requesting Comments on
Environmental Issues for the Proposed Cameron LNG Amended Expansion
Project and Notice of Public Scoping Session

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental document, that will discuss
the environmental impacts of the Cameron LNG Amended Expansion Project
involving several design modifications and enhancements to the approved
Cameron Expansion Project by Cameron LNG, LLC (Cameron LNG) in Cameron
and Calcasieu Parishes, Louisiana. The Commission will use this
environmental document in its decision-making process to determine
whether the project is in the public interest.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies regarding the project. As part of the National Environmental
Policy Act (NEPA) review process, the Commission takes into account
concerns the public may have about proposals and the environmental
impacts that could result from its action whenever it considers the
issuance of an authorization. This gathering of public input is
referred to as ``scoping.'' The main goal of the scoping process is to
focus the analysis in the environmental document on the important
environmental issues. Additional information about the Commission's
NEPA process is described below in the NEPA Process and Environmental
Document section of this notice.
    By this notice, the Commission requests public comments on the
scope of issues to address in the environmental document. To ensure
that your comments are timely and properly recorded, please submit your
comments so that the Commission receives them in Washington, DC, on or
before 5:00 p.m. Eastern Time on May 2, 2022. Comments may be submitted
in written form. Further details on how to submit comments are provided
in the Public Participation section of this notice.
    Your comments should focus on the potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts.

Your input will help the Commission staff determine what issues they
need to evaluate in the environmental document. Commission staff will
consider all written or verbal comments during the preparation of the
environmental document.
    If you submitted comments on this project to the Commission before
the opening of this docket on January 18, 2022, you will need to file
those comments in Docket No. CP22-41-000 to ensure they are considered
as part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.

Public Participation

    There are four methods you can use to submit your comments to the
Commission. Please carefully follow these instructions so that your
comments are properly recorded. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected].
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is also located on the Commission's website
(www.ferc.gov) under the link to FERC Online. With eFiling, you can
provide comments in a variety of formats by attaching them as a file
with your submission. New eFiling users must first create an account by
clicking on ``eRegister.'' You will be asked to select the type of
filing you are making; a comment on a particular project is considered
a ``Comment on a Filing'';
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP22-
41-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852; or
    (4) In lieu of sending written comments, the Commission invites you
to attend the virtual public scoping session its staff will conduct by
telephone, scheduled as follows:
    Date: Tuesday, April 26, 2022.
    Time: 6-8 p.m. Central Standard Time.
    Dial-in Number:<PHONE_NUMBER>.
    Participant passcode: 3375073.
    The primary goal of this scoping session is to have you identify
the specific environmental issues and concerns that should be
considered in the environmental document. Individual oral comments will
be taken on a one-on-one basis with a court reporter present on the
line. This format is designed to receive the maximum amount of oral
comments, in a convenient way during the timeframe allotted, and is in
response to the ongoing COVID-19 pandemic.
    There will not be a formal presentation by Commission staff. The
scoping session is scheduled from 6 p.m. to 8 p.m. Central Standard
Time. You may call at any time after 6 p.m. at which time you will be
placed on mute and hold. Calls will be answered in the order they are
received. Once answered, you will have the opportunity to provide your
comment directly to a court reporter with FERC staff or representative
present on the line. A time limit of five minutes will be implemented
for each commentor.
    Transcripts of all comments received during the scoping session
will be publicly available on FERC's eLibrary system (see the last page
of this notice for instructions on using eLibrary).
    It is important to note that the Commission provides equal
consideration to all comments received, whether filed in written form
or provided orally at a virtual scoping session.
    Additionally, the Commission offers a free service called
eSubscription which makes it easy to stay informed of all issuances and
submittals regarding the dockets/projects to which you subscribe. These
instant email notifications are the fastest way to receive notification
and provide a link to the document files which can reduce the amount of
time you spend researching proceedings. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.

Summary of the Proposed Project

    Cameron LNG proposes to amend its authorization under section 3 of
the Natural Gas Act for the Cameron Expansion Project issued on May 5,
2016 (Docket No. CP15-560-000). Specifically, Cameron LNG proposes to
modify the approved Train 4 and perform associated design enhancements.
In addition, Cameron LNG proposes to no longer construct Train 5. This
project would increase the overall reliability and capacity of Train 4
and eliminate impacts from construction and operation of Train 5. The
overall maximum production capacity of the Amended Expansion Project
would be reduced from 9.97 to 6.75 million tonnes per annum.
    The Cameron LNG Amended Expansion Project would consist of the
following design enhancements of Train 4:
     Add a feed gas booster compressor;
     add propane refrigeration;
     use open art technology on natural gas liquid extraction
process in lieu of a proprietary process;
     use a reduced temperature approach on air-cooled
exchangers and add to the number of exchangers;
     add an End Flash Gas (``EFG'') cold recovery exchanger;
     add an EFG recycle compressor;
     replace the refrigerant compressor gas turbine drives with
electric motor drivers;
     add hot oil heaters in lieu of the waste heat recovery
units;
     add an enclosed ground flare to handle the acid gas
stream;
     add a tie-in on the Thermal Oxidizer acid gas feed line as
pre-investment for possibility of future carbon sequestration; and
     utility services would be dedicated to Train 4.
    The Amended Expansion Project will also include the following
removal and relocation of facilities that have not yet been
constructed:
     Removal of the approved Train 5 and associated utilities;
     removal of the approved LNG Tank 5 (T-205);
     removal of the condensate storage tanks permitted with the
Expansion Project;
     removal of one boil-off gas compressor permitted with the
Expansion Project; and
     relocation of the Entergy Switch Yard for the Expansion
Project.
    In addition, Cameron LNG supplemented its application on March 18,
2022, by proposing an additional design enhancement to allow for the
capability to simultaneously load two LNG vessels at a rate of 12,000
cubic meters/hour at both the North and South Jetties. The dual loading
supplement would result in the following changes to the amendment
application:
     Upgrade one of the four LNG In-Tank Pumps in each LNG
Storage Tank

(the low capacity pump in each tank will be upgraded to match the three
existing high-capacity pumps):
     addition of a parallel 36-inch-diameter loading line to
provide the system hydraulics necessary for the increased dual loading
rate, up to 24,000 cubic meters/hour (the line would be added using
interconnections to the existing loading header);
     addition of a new impoundment basin adjacent to the
existing impoundment basin serving the loading area; and
     addition of a pre-investment tie-in on the acid gas feed
line to the Thermal Oxidizers for Trains 1-3 to allow future connection
to potential carbon sequestration facilities that may be developed in
the area (similar to the pre-investment tie-in proposed for Train 4).
    The general location of the project facilities is shown in appendix
1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary''. For instructions on
connecting to eLibrary, refer to the last page of this notice. At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact
FERC at [email protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
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Land Requirements for Construction

    The Amended Expansion Project facilities would be within the site
of the existing Cameron LNG Terminal. Construction of the project would
be wholly within the footprint authorized by the Commission for the
Expansion Project (Docket No. CP15-560-000).

NEPA Process and the Environmental Document

    Any environmental document issued by the Commission will discuss
impacts that could occur as a result of the construction and operation
of the proposed project under the relevant general resource areas.
Commission staff have already identified the following preliminary list
of resources that may be impacted by the project and would be included
in our analysis:
     Environmental justice;
     air quality and noise; and
     reliability and safety.
    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project and make recommendations on
how to lessen or avoid impacts on the various resource areas. Your
comments will help Commission staff identify and focus on the issues
that might have an effect on the human environment and potentially
eliminate others from further study and discussion in the environmental
document.
    Following this scoping period, Commission staff will determine
whether to prepare an Environmental Assessment (EA) or an Environmental
Impact Statement (EIS). The EA or the EIS will present Commission
staff's independent analysis of the issues. If Commission staff
prepares an EA, a Notice of Schedule for the Preparation of an
Environmental Assessment will be issued. The EA may be issued for an
allotted public comment period. The Commission would consider timely
comments on the EA before making its decision regarding the proposed
project. If Commission staff prepares an EIS, a Notice of Intent to
Prepare an EIS/Notice of Schedule will be issued. Staff will then
prepare a draft EIS which will be issued for public comment. Commission
staff will consider all timely comments received during the comment
period on the draft EIS and revise the document, as necessary, before
issuing a final EIS. Any EA or draft and final EIS will be available in
electronic format in the public record through eLibrary \2\ and the
Commission's natural gas environmental documents web page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you will receive instant email notification
when the environmental document is issued.
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    \2\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
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    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the environmental document.\3\ Agencies that would like
to request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at title 40, Code of Federal
Regulations, section 1501.8.
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Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Office,
and to solicit their views and those of other government agencies,
interested Indian tribes, and the public on the project's potential
effects on historic properties.\4\ The environmental document for this
project will document findings on the impacts on historic properties
and summarize the status of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at title 36, Code of Federal Regulations, part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes: Federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project and includes a mailing address with their
comments. Commission staff will update the environmental mailing list
as the analysis proceeds to ensure that Commission notices related to
this environmental review are sent to all individuals, organizations,
and government entities interested in and/or potentially affected by
the proposed project.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following steps:
    (1) Send an email to [email protected] stating your
request. You must include the docket number CP22-41-000 in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments.

    OR

    (2) Return the attached ``Mailing List Update Form'' (appendix 2).

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC

website at www.ferc.gov using the eLibrary link. Click on the eLibrary
link, click on ``General Search'' and enter the docket number in the
``Docket Number'' field. Be sure you have selected an appropriate date
range. For assistance, please contact FERC Online Support at
[email protected] or<PHONE_NUMBER>, or for TTY, contact (202)
502-8659. The eLibrary link also provides access to the texts of all
formal documents issued by the Commission, such as orders, notices, and
rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: March 31, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-07282 Filed 4-5-22; 8:45 am]
BILLING CODE 6717-01-P