[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11605-11607]
[DOCID:fr11mr10-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61648; File No. SR-FINRA-2010-009]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Provide Additional Relief Relating to Certain
FINRA/Nasdaq Trade Reporting Facility and OTC Reporting Facility Fees

March 4, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 1, 2010, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by FINRA. FINRA has
designated the proposed rule change as ``establishing or changing a
due, fee or other charge'' under Section 19(b)(3)(A)(ii) of the Act \3\
and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal
effective upon receipt of this filing by the Commission. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).

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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to waive and issue a credit for fees that were
charged to FINRA members under FINRA Rules 7620A and 7710 for the
submission of ``as/of'' trade reports to the FINRA/Nasdaq Trade
Reporting Facility (``FINRA/Nasdaq TRF'') and the OTC Reporting
Facility (``ORF''), respectively, for trades executed on eight days in
the months of August and September 2009. The relief proposed herein is
in addition to the fee relief provided under SR-FINRA-2009-088. The
proposed rule change does not require amendments to any FINRA rules.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Pursuant to FINRA Rules 7620A and 7710, members are charged fees
for trade reporting to the FINRA/Nasdaq TRF and ORF, respectively, and
the fee for the submission of late trade reports, including ``as/of''
reports, is higher than the fee for the submission of timely trade
reports. ``As/of'' reports are reports of trades that were executed on
a date prior to the date they were reported.
    During the months of August and September 2009, various Automated
Confirmation Transaction Service (``ACT'') technology issues impacted
trade reporting to the FINRA/Nasdaq TRF and the ORF for a period of
eight days: August 3, August 4, August 5, August 17, August 21,
September 16, September 25 and September 28. Due to the ACT technology
issues, members were unable to report trades on trade date and thus
incurred higher than normal reporting charges due to the higher number
of ``as/of'' reports that they were compelled to submit.
    On December 7, 2009, FINRA filed proposed rule change SR-FINRA-
2009-088, and on December 17, 2009, the SEC published notice of filing
and immediate effectiveness of SR-FINRA-2009-088 in the Federal
Register.\5\ In that filing, FINRA proposed to waive the fees for ``as/
of'' trade reports submitted on the following days in 2009: August 4,
August 5, August 6, August 18, August 24, September 17, September 28
and September 29. These dates are the next business day (T+1) following
the days on which the ACT technology issues occurred. The relief
proposed in SR-FINRA-2009-088 was based on the assumption that members
that were unable to report on trade date due to ACT technology issues
reported the trades on the following business day (T+1).
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    \5\ See Securities Exchange Act Release No. 61160 (December 14,
2009), 74 FR 67284 (December 18, 2009) (Notice of Filing and
Immediate Effectiveness of SR-FINRA-2009-088).
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    Subsequent to publication of notice in the Federal Register,
however, FINRA obtained additional information from Nasdaq, the FINRA/
Nasdaq TRF ``Business Member'' and ACT technology provider, and it was
determined that the scope of the relief provided under SR-FINRA-2009-
088 is too narrow. Some members that were unable to report on trade
date did not, in fact, report on the following business day (T+1), but
reported two (or perhaps more) days after trade date (T+2 or later).
The relief provided under SR-FINRA-2009-088 does not reach these
members.
    Accordingly, FINRA is proposing to waive the fees for all ``as/of''
trade reports submitted on T+2 or later to the FINRA/Nasdaq TRF and ORF
that have a trade execution date of August 3, August 4, August 5,
August 17, August 21, September 16, September 25 and September 28, 2009
(i.e., the dates on which the ACT technology issues occurred). The
proposed relief will apply to fees for ``as/of'' trade reports
submitted through December 31, 2009. Members will be issued a credit
for the fees on a future invoice.\6\
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    \6\ FINRA notes that a similar proposal to waive and issue a
credit for certain cancel fees was the subject of a filing by NASDAQ
OMX PHLX, Inc. See Securities Exchange Act Release No. 60853
(October 21, 2009), 74 FR 55594 (October 28, 2009) (Notice of Filing
and Immediate Effectiveness of File No. SR-PHLX-2009-89).
---------------------------------------------------------------------------

    The proposed relief is in addition to the relief provided in SR-
FINRA-2009-088 for fees charged on ``as/of'' trade reports submitted on
T+1. FINRA believes that such additional relief is appropriate in order
to make all members whole, since the higher charges were the result of
an ACT technology issue and not the fault of the member.
    FINRA has filed the proposed rule change for immediate
effectiveness. The operative date will be the date of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(5) of the Act,\7\ which requires, among
other things, that FINRA rules provide for the equitable allocation of
reasonable dues, fees and other charges among members and issuers and
other persons using any facility or system that FINRA operates or
controls. FINRA believes that the proposed waiver and credit of the
``as/of'' reporting fees is fair and equitable in that it will apply
uniformly to all FINRA members that submitted ``as/of'' trade reports
to the FINRA/Nasdaq TRF and ORF for trades with the designated trade
dates.
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    \7\ 15 U.S.C. 78o-3(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will impose
any burden on competition not necessary or appropriate in furtherance
of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act \8\ and paragraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of the proposed
rule change, the Commission may summarily abrogate such rule change if
it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2010-009 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2010-009. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make publicly
available. All submissions should refer to File Number SR-FINRA-2010-
009 and should be submitted on or before April 1, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5217 Filed 3-10-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Notices]
[Page 2707]
[FR Doc No: 2023-00656]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96624; File No. SR-NSCC-2022-802]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Extension of Review Period of Advance Notice
Related to Certain Enhancements to the Gap Risk Measure and the VaR
Charge

January 10, 2023.
    On December 2, 2022, the National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') advance notice SR-NSCC-2022-802 (``Advance Notice'')
pursuant to Section 806(e)(1) of Title VIII of the Dodd-Frank Wall
Street Reform and Consumer Protection Act, entitled Payment, Clearing
and Settlement Supervision Act of 2010 (``Clearing Supervision Act'')
\1\ and Rule 19b-4(n)(1)(i) \2\ under the Securities Exchange Act of
1934 (``Exchange Act'') \3\ to amend NSCC's Rules and Procedures to
enhance the calculation of the volatility component of the Clearing
Fund formula that utilizes a parametric Value-at-Risk (``VaR'') model
(``VaR Charge''), specifically with respect to the Gap Risk Measure
thereof.\4\ The Advance Notice was published for public comment in the
Federal Register on December 21, 2022.\5\ The Commission received a
comment regarding the changes proposed in the Advance Notice.\6\
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    \1\ 12 U.S.C. 5465(e)(1).
    \2\ 17 CFR 240.19b-4(n)(1)(i).
    \3\ 15 U.S.C. 78a et seq.
    \4\ See Notice of Filing, infra note 5.
    \5\ Securities Exchange Act Release No. 96513 (Dec. 15, 2022),
87 FR 78175 (Dec. 21, 2022) (File No. SR-NSCC-2022-802) (``Notice of
Filing''). On December 2, 2022, NSCC also filed a related proposed
rule change (SR-NSCC-2022-015) with the Commission pursuant to
Section 19(b)(1) of the Exchange Act and Rule 19b-4 thereunder
(``Proposed Rule Change''). 15 U.S.C. 78s(b)(1) and 17 CFR 240.19b-
4, respectively. In the Proposed Rule Change, which was published in
the Federal Register on December 21, 2022, NSCC seeks approval of
proposed changes to its rules necessary to implement the Advance
Notice. Securities Exchange Act Release No. 96511 (Dec. 15, 2022),
87 FR 78157 (Dec. 21, 2022) (File No. SR-NSCC-2022-015). The comment
period for the related Proposed Rule Change filing will close on
January 11, 2023.
    \6\ https://www.sec.gov/comments/sr-nscc-2022-802/srnscc2022802.htm. Since the proposal contained in the Advance
Notice was also filed as a proposed rule change, all public comments
received on the proposal are considered regardless of whether the
comments are submitted on the Proposed Rule Change or the Advance
Notice. Comments on the Proposed Rule Change are available at
https://www.sec.gov/comments/sr-nscc-2022-015/srnscc2022015.htm.
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    Section 806(e)(1)(G) of the Clearing Supervision Act provides that
NSCC may implement the changes if it has not received an objection to
the proposed changes within 60 days of the later of (i) the date that
the Commission receives the Advance Notice or (ii) the date that any
additional information requested by the Commission is received,\7\
unless extended as described below.
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    \7\ 12 U.S.C. 5465(e)(1)(G).
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    Pursuant to Section 806(e)(1)(H) of the Clearing Supervision Act,
the Commission may extend the review period of an advance notice for an
additional 60 days, if the changes proposed in the advance notice raise
novel or complex issues, subject to the Commission providing the
clearing agency with prompt written notice of the extension.\8\
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    \8\ 12 U.S.C. 5465(e)(1)(H).
---------------------------------------------------------------------------

    Here, as the Commission has not requested any additional
information, the date that is 60 days after NSCC filed the Advance
Notice with the Commission is January 31, 2023. However, the Commission
finds the issues raised by the Advance Notice complex because the
proposal would revise the methodology by which NSCC determines the
appropriate margin to capture the gap risk posed by a member's
portfolio, including by making the gap risk measure additive as opposed
to substitutive, expanding its application to the two largest positions
instead of only the largest position, amending the scope of products
subject to the gap risk measure, and changing the haircuts and
methodology for determining the applicable haircuts.\9\ Therefore, the
Commission finds it appropriate to extend the review period of the
Advance Notice for an additional 60 days under Section 806(e)(1)(H) of
the Clearing Supervision Act.\10\
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    \9\ See Notice of Filing, infra note 5.
    \10\ 12 U.S.C. 5465(e)(1)(H).
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    Accordingly, the Commission, pursuant to Section 806(e)(1)(H) of
the Clearing Supervision Act,\11\ extends the review period for an
additional 60 days so that the Commission shall have until April 1,
2023 to issue an objection or non-objection to advance notice SR-NSCC-
2022-802.
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    \11\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(94).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-00656 Filed 1-13-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Rules and Regulations]
[Pages 47297-47300]
[FR Doc No: 2020-16405]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0212; Product Identifier 2018-SW-097-AD; Amendment
39-21180; AD 2020-15-17]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Sikorsky Aircraft Corporation Model S-76C helicopters. This AD
was prompted by reports of inaccurate main gear box (MGB) indications
in flight. This AD requires updating the remote data acquisition unit
(RDAU) software and re-identifying the RDAU and, for certain
helicopters, updating the software of the display unit (DU) and re-
identifying the DU. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective September 9, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of September 9,
2020.

ADDRESSES: For service information identified in this final rule,
contact your local Sikorsky Field Representative or Sikorsky's Service
Engineering Group at Sikorsky Aircraft Corporation, 124 Quarry Road,
Trumbull, CT 06611; phone: 1-800-946-4337 (1-800-Winged-S); email:
<EMAIL_ADDRESS>Operators may also log on to the
Sikorsky 360 website at https://www.sikorsky360.com. You may view this
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0212; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of

Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Min Zhang, Aviation Safety Engineer,
Boston ACO Branch, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7161; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Sikorsky
Aircraft Corporation Model S-76C helicopters. The NPRM published in the
Federal Register on April 6, 2020 (85 FR 19110). The NPRM was prompted
by reports of inaccurate MGB indications in flight. The NPRM proposed
to require updating the RDAU software and re-identifying the RDAU and,
for certain helicopters, updating the software of the DU and re-
identifying the DU.
    The FAA is issuing this AD to address inaccurate MGB indications in
flight, resulting in multiple erroneous values/annunciations on channel
B, which could cause the flight crew to land immediately, and
consequent possible loss of the helicopter, injury, or fatality.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor editorial changes. The FAA has determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed the following Sikorsky service information.
    Alert Service Bulletin 76-31-3, Revision B, dated June 26, 2018;
Alert Service Bulletin 76-31-4, Revision A, dated May 30, 2018; and
Alert Service Bulletin 76-31-5, dated July 31, 2018. This service
information describes procedures for updating the RDAU software and re-
identifying the RDAU. This service information also describes
procedures for sending the inspection results to Sikorsky Aircraft
Corporation. These documents are distinct since they apply to specific
helicopter models in different configurations (different part numbered
RDAU units).
    Service Bulletin 76-006, Revision A, dated August 23, 2018. This
service information describes procedures for updating the software of
DU part number 76450-01098-101, and re-identifying the DU as part
number 76450-01098-108. This service information also describes
procedures for sending the inspection results to Sikorsky Aircraft
Corporation.
    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.

Differences Between This AD and the Service Information

    The service information recommends accomplishing the update of the
RDAU software and re-identification of the RDAU and, for certain
helicopters, update of the software of the DU and re-identification of
the DU, depending on service information, no later than a specific
calendar date (April 30, 2019 for Alert Service Bulletin 76-31-3,
Revision B, dated June 26, 2018; June 30, 2019 for Alert Service
Bulletin 76-31-4, Revision A, dated May 30, 2018; or July 31, 2019 for
Alert Service Bulletin 76-31-5, dated July 31, 2018). In developing an
appropriate compliance time for this AD, the FAA considered factors
including the manufacturer's recommendation, the degree of urgency
associated with the subject unsafe condition, and the average
utilization of the affected fleet. After considering these factors, the
FAA finds that a 500 hours time-in-service compliance time (which is
approximately one year based on the average annual flight hours for
Sikorsky Aircraft Corporation Model S-76C helicopters) represents an
appropriate interval of time for affected helicopters to continue to
operate without compromising safety.

Costs of Compliance

    The FAA estimates that this AD affects 99 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Update RDAU software (99 helicopters).  3 work-hours x $85 per               (*)            $255         $25,245
                                         hour = $255.
Update display units (52 helicopters).  7 work-hours x $85 per               (*)             595          30,940
                                         hour = $595.
Reporting (99 helicopters)............  1 work-hour x $85 per                 $0              85           8,415
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable the FAA to provide parts cost estimates for the
  actions specified in this AD.

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. The FAA does not control warranty coverage for
affected individuals. As a result, the FAA has included all known costs
in the cost estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is 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.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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):

2020-15-17 Sikorsky Aircraft Corporation: Amendment 39-21180; Docket
No. FAA-2020-0212; Product Identifier 2018-SW-097-AD.

(a) Effective Date

    This AD is effective September 9, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Sikorsky Aircraft Corporation Model S-76C
helicopters, certificated in any category, equipped with remote data
acquisition unit (RDAU) part number 76450-01098-106, 76450-01098-
107, or 76450-01098-109.

(d) Subject

    Joint Aircraft Service Component (JASC) Code 3100, Indicating/
recording system.

(e) Unsafe Condition

    This AD was prompted by reports of inaccurate main gear box
(MGB) indications in flight. The FAA is issuing this AD to address
inaccurate MGB indications in flight, resulting in multiple
erroneous values/annunciations on channel B, which could cause the
flight crew to land immediately, and consequent possible loss of the
helicopter, injury, or fatality.

(f) Compliance

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

(g) RDAU and Display Unit (DU) Updates

    Within 500 hours time-in-service after the effective date of
this AD, do the actions specified in paragraphs (g)(1) through (4)
of this AD, as applicable to your helicopter.
    (1) For helicopters equipped with RDAU part number 76450-01098-
109, update the RDAU software and re-identify the RDAU in accordance
with Section 3., Paragraphs A. through J. of the Accomplishment
Instructions of Sikorsky Alert Service Bulletin 76-31-3, Revision B,
dated June 26, 2018, except you are not required to return the RDAU
to Parker Fluid Systems Division (FSD).
    (2) For helicopters equipped with RDAU part number 76450-01098-
107, update the RDAU software and re-identify the RDAU in accordance
with Section 3., Paragraphs A. through J. of the Accomplishment
Instructions of Sikorsky Alert Service Bulletin 76-31-4, Revision A,
dated May 30, 2018, except you are not required to return the RDAU
to Parker FSD.
    (3) For helicopters equipped with RDAU part number 76450-01098-
106, update the RDAU software and re-identify the RDAU in accordance
with Section 3., Paragraphs A. through K. of the Accomplishment
Instructions of Sikorsky Alert Service Bulletin 76-31-5, dated July
31, 2018, except you are not required to return the RDAU to Parker
FSD.
    (4) For helicopters equipped with RDAU part number 76450-01098-
106, update the software of DU part number 76450-01098-101 and re-
identify the DU as part number 76450-01098-108, in accordance with
Section 3., Paragraphs A. through J. of the Accomplishment
Instructions of Sikorsky Service Bulletin 76-006, Revision A, dated
August 23, 2018, except you are not required to return the DU to
Parker FSD.

(h) Parts Installation Limitations

    As of the effective date of this AD, no person may install, on
any helicopter, a DU part number 76450-01098-101, unless it has been
modified in accordance with the requirements of paragraph (g)(4) of
this AD.

(i) Reporting

    At the applicable time specified in paragraph (i)(1) or (2) of
this AD, submit a report of compliance with the actions specified in
paragraphs (g)(1) through (4) of this AD, as applicable to your
helicopter. The report must include the document number and title of
the service information used, the owner and/or operator of the
helicopter, the submitter's name, date, and the helicopter serial
number. Submit the report to Sikorsky Aircraft Corporation in
accordance with Section 3., Paragraph A. (Record of Compliance) of
the Accomplishment Instructions of Sikorsky Alert Service Bulletin
76-31-3, Revision B, dated June 26, 2018; Section 3., Paragraph L.
of the Accomplishment Instructions of Sikorsky Alert Service
Bulletin 76-31-4, Revision A, dated May 30, 2018; Section 3.,
Paragraph M. of the Accomplishment Instructions of Sikorsky Alert
Service Bulletin 76-31-5, dated July 31, 2018; or Section 3.,
Paragraph L. of the Accomplishment Instructions of Sikorsky Service
Bulletin 76-006, Revision A, dated August 23, 2018, as applicable to
your helicopter.
    (1) If the action was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the action was done before the effective date of this AD:
Submit the report within 30 days after the effective date of this
AD.

(j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by
paragraphs (g)(1) and (i) of this AD, if those actions were
performed before the effective date of this AD using Sikorsky Alert
Service Bulletin 76-31-3, dated March 2, 2018; or Sikorsky Alert
Service Bulletin 76-31-3, Revision A, dated March 29, 2018.
    (2) This paragraph provides credit for the actions required by
paragraphs (g)(2) and (i) of this AD, if those actions were
performed before the effective date of this AD using Sikorsky Alert
Service Bulletin 76-31-4, dated May 17, 2018.
    (3) This paragraph provides credit for the actions required by
paragraphs (g)(4) and (i) of this AD, if those actions were
performed before the effective date of this AD using Sikorsky
Service Bulletin 76-006, dated July 26, 2018.

(k) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public

reporting for this collection of information is estimated to be
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden
estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to Information
Collection Clearance Officer, Federal Aviation Administration, 10101
Hillwood Parkway, Fort Worth, TX 76177-1524.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston 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 (m)(1) of this AD.
    (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.

(m) Related Information

    (1) For more information about this AD, contact Min Zhang,
Aviation Safety Engineer, Boston ACO Branch, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (n)(3) and (4) of this AD.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Sikorsky Alert Service Bulletin 76-31-3, Revision B, dated
June 26, 2018.
    (ii) Sikorsky Alert Service Bulletin 76-31-4, Revision A, dated
May 30, 2018.
    (iii) Sikorsky Alert Service Bulletin 76-31-5, dated July 31,
2018.
    (iv) Sikorsky Service Bulletin 76-006, Revision A, dated August
23, 2018.
    (3) For service information identified in this AD, contact your
local Sikorsky Field Representative or Sikorsky's Service
Engineering Group at Sikorsky Aircraft Corporation, 124 Quarry Road,
Trumbull, CT 06611; phone: 1-800-946-4337 (1-800-Winged-S); email:
<EMAIL_ADDRESS>Operators may also log on to
the Sikorsky 360 website at https://www.sikorsky360.com.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 16, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-16405 Filed 8-4-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48096-48098]
[FR Doc No: 2017-22320]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2017-N-4951]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Humanitarian Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of

certain information by the Agency. Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for humanitarian use devices (HUDs).

DATES: Submit either electronic or written comments on the collection
of information by December 15, 2017.

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 December 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 15, 2017. 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 No.
FDA 2017-N-4951 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Humanitarian Use
Devices.'' 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 Office 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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Devices; Humanitarian Use Devices--21 CFR 814

OMB Control Number 0910-0332--Extension

    This collection of information implements the HUDs provision of
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360j(m)) and part 814, subpart H (21 CFR part 814,
subpart H). Under section 520(m) of the FD&C Act, FDA is authorized to
exempt an HUD from the effectiveness requirements of

sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided
that the device: (1) Is designed to treat or diagnose a disease or
condition that affects no more than 8,000 individuals in the United
States; (2) would not be available to a person with a disease or
condition unless an exemption is granted and there is no comparable
device other than another HUD approved under this exemption that is
available to treat or diagnose such disease or condition; and (3) will
not expose patients to an unreasonable or significant risk of illness
or injury and the probable benefit to health from the use of the device
outweighs the risk of injury or illness from its use, taking into
account the probable risks and benefits of currently available devices
or alternative forms of treatment.
    Respondents may submit a humanitarian device exemption (HDE)
application seeking exemption from the effectiveness requirements of
sections 514 and 515 of the FD&C Act as authorized by section
520(m)(2). The information collected will assist FDA in making
determinations on the following: (1) Whether to grant HUD designation
of a medical device; (2) whether to exempt an HUD from the
effectiveness requirements under sections 514 and 515 of the FD&C Act,
provided that the device meets requirements set forth under section
520(m) of the FD&C Act; and (3) whether to grant marketing approval(s)
for the HUD. Failure to collect this information would prevent FDA from
making a determination on the factors listed previously in this
document. Further, the collected information would also enable FDA to
determine whether the holder of an HUD is in compliance with the HUD
provisions under section 520(m) of the FD&C Act.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation--                 19               1              19              40             760
 814.102........................
HDE Application--814.104........               3               1               3             320             960
HDE Amendments and resubmitted                 6               5              30              50           1,500
 HDEs--814.106..................
HDE Supplements--814.108........             110               1             110              80           8,800
Notification of withdrawal of an               1               1               1               1               1
 HDE--814.116(e)(3).............
Notification of withdrawal of                  1               1               1               2               2
 Institutional Review Board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              35               1              35             120           4,200
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          16,223
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Average  burden
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers    recordkeeping       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2).........................................             247                1              247                2              494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)..........................              22                1               22                1               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The number of respondents in tables 1, 2, and 3 of this document
are an average based on data for the previous 3 years, i.e., fiscal
years 2014 through 2016. The number of annual reports submitted under
Sec.  814.126(b)(1) in table 1 reflects 35 respondents with approved
HUD applications. Under Sec.  814.126(b)(2) in table 2, the estimated
number of recordkeepers is 247.
    The number of respondents has been adjusted to reflect updated
respondent data. This has resulted in an overall decrease of 2,971
hours to the total estimated annual reporting burden. There have been
no program changes and the estimated Average Burden per Response has
not changed for any of the information collections since the last OMB
approval.

    Dated: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22320 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Proposed Rules]
[Page 44181-44184]
[DOCID:fr28jy10-30]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0423; FRL-8835-7]

Mevinphos; Proposed Data Call-in Order for Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed order.

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SUMMARY: This document proposes to require the submission of various
data required to support the continuation of the tolerances for the
pesticide mevinphos. Pesticide tolerances are established under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: Comments must be received on or before September 27, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0423, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2010-0423. EPA's policy is that all comments received will be included
in the 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'' system,
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 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 at http://www.regulations.gov. 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, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: K. Avivah Jakob, Pesticide Re-
evaluation Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. 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 person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting 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.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. FFDCA Data Call-In Authority

    In this document, EPA proposes to issue an order requiring the
submission of various data to support the continuation of the mevinphos
tolerances at 40 CFR 180.157. Under section 408(f) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(f), EPA is authorized to
require, by order, submission of data ``reasonably required to support
the continuation of a tolerance'' when such data cannot be obtained
under the Data Call-In authority of section 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136a(c)(2)(B), or section 4 of the Toxic Substances Control Act (TSCA),
15 U.S.C. 2603. A section 408(f) Data Call-In order may only be issued
following notice and a comment period of not less than 60 days.
    A section 408(f) Data Call-In order must contain the following
elements:
    1. A requirement that one or more persons submit to EPA a notice
identifying the person(s) who commit to submit the data required in the
order.
    2. A description of the required data and the required reports
connected to such data.
    3. An explanation of why the required data could not be obtained
under section 3(c)(2)(B) of FIFRA or section 4 of TSCA.
    4. The required submission date for the notice identifying one or
more interested persons who commit to submit the required data and the
required submission dates for all the data and reports required in the
order. (21 U.S.C. 346a(f)(1)(C)).
    EPA may by order modify or revoke the affected tolerances if any
one of the following submissions is not made in a timely manner:
     A notice identifying one or more interested persons who
commit to submit the data.
     The data itself.
     The reports required under a section 408(f) order are not
submitted by the date specified in the order. (21 U.S.C. 346a(f)(2)).

III. Regulatory Background for Mevinphos

    Mevinphos is a contact/systemic insecticide-acaricide. It is not
currently registered under FIFRA and may not be sold, distributed, or
used in the United States. Mevinphos' FIFRA registration was canceled
in 1994. However, 15 FFDCA tolerances remain for residues of mevinphos
on the following commodities: Broccoli, cabbage, cauliflower, celery,
cucumbers, grapes, lettuce, melons, peas, peppers, spinach,
strawberries, summer squash, tomatoes, and watermelon (40 CFR 180.157).
Since there are currently no domestic registrations for mevinphos,
these tolerances are referred to as ``import tolerances.''
    Mevinphos is a member of a family of pesticides known as the
organophosphates. EPA has concluded mevinphos and other organophosphate
pesticides share a common mechanism of toxicity. As with other
organophosphates, the principal toxic effects induced by mevinphos are
related to its cholinesterase-inhibiting activity. It produces the
associated clinical signs such as tremors, unsteady gait, decreased
activity, salivation, disturbed balance in rats and rabbits, and
decreased cholinesterase activity (plasma, brain) in rats and rabbits
following acute, subchronic, and chronic oral exposure.
    In September 2000, EPA issued an Interim Tolerance Reassessment
Eligibility Decision (ITRED) for mevinphos in connection with its
obligation under the Food Quality Protection Act of 1996 (FQPA), to
evaluate whether all tolerances in existence at the time of the passage
of FQPA met the revised safety standard that the FQPA adopted for FFDCA
section 408. In the ITRED, EPA concluded that the risks of mevinphos
when evaluated in isolation from other organophosphates met the revised
safety standard in FFDCA section 408. This conclusion was labeled
``interim,'' however, because EPA had not yet completed a cumulative
risk assessment for the organophosphates. In July 2006, EPA completed
its cumulative risk assessment for the organophosphate pesticides
finding that these tolerances met the revised safety standard.
    The ITRED called attention to several data gaps for mevinphos
including:
    1. A developmental neurotoxicity (DNT) study in rats (with expanded
protocol to extend the postnatal treatment period and to measure
cholinesterase inhibition in offspring) as was required for all
organophosphate pesticides.
    2. Various studies evaluating mevinphos residue levels on treated
crops. EPA noted that it would be taking steps to require the
submission of this data. Subsequently, the manufacturer of mevinphos
submitted residue data for grapes and frozen storage stability data for
broccoli, cucumbers, lettuce, tomatoes, and strawberries. However, the
registrant has not submitted a DNT study or residue data for the
remaining imported commodities.
    Under section 3(g) of FIFRA and implementing regulations, EPA has

established a review program for pesticides registered under FIFRA. The
goal of that program is a periodic review of pesticide registrations
every 15 years to ensure that the registrations satisfy FIFRA standards
and are based on ``current scientific and other knowledge regarding the
pesticide.'' (40 CFR 155.40(a)). EPA is in the preliminary stages of
the registration review process for organophosphate pesticides.
Although mevinphos is not registered under FIFRA, EPA will be re-
examining mevinphos with the other registered organophosphates because
of the organophosphates shared mechanism of toxicity.
    In re-examining mevinphos, EPA has identified several studies noted
in the ITRED as data gaps for which data have not been submitted and
one new regulatory data requirement for which a study is needed. These
data are necessary to support the continuation of mevinphos tolerances
and are listed below.

 IV. Data Requirements

A. Required Data and Reports

    Pursuant to FFDCA section 408(f), EPA has determined that
additional data are reasonably required to support the continuation of
the tolerances for mevinphos which are codified at 40 CFR 180.157.
Accordingly, EPA proposes to issue a final order requiring the
submission of the following data:
    1. Comparative Cholinesterase Assay (Test Guideline 870.6300). A
protocol and a final report are required.
    Rationale. As an organophosphate pesticide (OP), inhibition of
acetylcholinesterase (AChE) is the critical effect for use in human
health risk assessment. Many OPs were subject to a Data-Call-In for the
developmental neurotoxicity study (DNT). This DCI also included the
requirement for AChE inhibition data to evaluate comparative
sensitivity in juvenile and adult rats. These data are most often
collected in a study called the comparative cholinesterase assay (CCA).
Since that time, CCA studies for more than 20 OPs have been submitted
to OPP. Although for some OPs no difference in sensitivity has been
observed in juvenile and adult animals, for many of the OPs, juveniles
have been shown to be more sensitive. At this time, OPP has determined
that a CCA is required for mevinphos to evaluate the potential for
increased sensitivity in juvenile animals compared with that of adult
animals. Given that the AChE data provided in the CCAs have provided
more sensitive results than DNT studies for the OPs, a DNT study for
mevinphos is not required at this time.
    2. Immunotoxicity Study (Test Guideline 870.7800). A final report
and protocol are required.
    Rationale. This is a new data requirement under 40 CFR part 158 as
a part of the data requirements for registration of a pesticide (food
and non-food uses).
    The Immunotoxicity Test Guideline (Harmonized Guideline 870.7800)
prescribes functional immunotoxicity testing and is designed to
evaluate the potential of a repeated chemical exposure to produce
adverse effects (i.e., suppression) on the immune system.
Immunosuppression is a deficit in the ability of the immune system to
respond to a challenge of bacterial or viral infections such as
tuberculosis (TB), severe acquired respiratory syndrome (SARS), or
neoplasia.
    3. Directions for Use (Test Guideline 860.1200)
    Rationale. The Agency needs use directions, which appear on the
Mexico label(s).
    4. Crop Field Trials (Test Guideline 860.1500) - (broccoli,
cabbage, cauliflower, celery, grapes, lettuce, peas, peppers, spinach,
strawberries, summer squash, and tomatoes.)
    Rationale. Field trials are required for each commodity/commodity
group according to guidelines that take into account where the crop is
grown and how much of the crop is grown. Field trials are required for
each type of formulation because the formulation can have significant
effect on the magnitude of the pesticide residue left on the crop.
Residue trials also need to represent the maximum application rate on
the label and have a geographic distribution representative of the
commodity/commodity group. On June 1, 2000 (65 FR 35069) (FRL-6559-3),
EPA published in the Federal Register, a Notice which provided detailed
guidance on applying current U.S. data requirements for the
establishment or continuance of tolerances for pesticide residues in or
on imported foods. A copy of that Notice is available in the docket of
this proposed order. That Notice contains instructions for determining
number and location of field trials.
    5. Processing Study (tomatoes) (Test Guideline 860.1520)
    Rationale. Processing studies are required to determine whether
residues in raw commodities may be expected to degrade or concentrate
during food processing. If residues concentrate in a processed
commodity, a food or feed additive tolerance must be established. If
residues do not concentrate in a processed commodity, the tolerance for
the raw agricultural commodity applies to all processed food or feed
derived from it.

B. Persons who Commit to Submit the Required Data

    After this 60-day comment period closes, the Agency will respond to
comments, if appropriate, and may issue a final order requiring the
submission of various data for mevinphos in the Federal Register. If
EPA issues such an order, persons who are interested in the
continuation of the mevinphos tolerances must notify the Agency by
completing and submitting the required ``Sec. 408(f) Order Response''
form (available in the docket) within 90 days after publication of the
final order in the Federal Register.
    The ``Sec. 408(f) Order Response Form'' requires the identification
of persons who will submit the required data and lists the options
available to support the required data:
    i. Develop new data.
    ii. Submit an Existing Study -- submit existing data not
submitted previously to the Agency by anyone,
    iii. Upgrade a Study - submit or cite data to upgrade a study
classified by EPA as partially acceptable and upgradable,
    iv. Cite an Existing Study - cite an existing study that EPA
classified as acceptable or an existing study that has been
submitted but not reviewed by the Agency.

C. Required Dates for Submission of Data/Reports

    The table below lists the time allocated for both the completion
and submission of each study. The required submission date is
calculated from the date of publication in the Federal Register of the
final order.

----------------------------------------------------------------------------------------------------------------
                                                                 Timeframe for protocol     Timeframe for data
     Guideline Requirement Number            Study Title               submission               submission
----------------------------------------------------------------------------------------------------------------
860.1200                               Directions for use       Not required             12 months
----------------------------------------------------------------------------------------------------------------

860.1500                               Crop Field Trials        Not Required             24 months
                                        (broccoli, cabbage,
                                        cauliflower, celery,
                                        grapes, lettuce, peas,
                                        peppers, spinach,
                                        strawberries, summer
                                        squash, and tomatoes)
----------------------------------------------------------------------------------------------------------------
860.1520                               Processing studies       Not Required             24 months
                                        (tomatoes)
----------------------------------------------------------------------------------------------------------------
870.6300                               Comparative              6 months                 12 months
                                        Cholinesterase Assay
----------------------------------------------------------------------------------------------------------------
870.7800                               Immunotoxicity Study     6 months                 12 months
----------------------------------------------------------------------------------------------------------------

D. Failure to Submit

    If the Agency does not receive a Sec. 408(f) Response Form
identifying a person who agrees to submit the required data within 90
days after publication of the final order, EPA will proceed to revoke
the mevinphos tolerances at 40 CFR 180.157. Such revocation order is
subject to the objection and hearing procedure in FFDCA section
408(g)(2) but the only material issue in such a procedure is whether a
submission required by the order was made in a timely fashion.
    Additional events that may be the basis for modification or
revocation of mevinphos tolerances include, but are not limited to the
following:
    1. No person submits on the required schedule an acceptable
proposal or final protocol when such is required to be submitted to the
Agency for review.
    2. No person submits on the required schedule an adequate progress
report on a study as required by the order.
    3. No person submits on the required schedule acceptable data as
required by the final order.
    4. No person submits supportable certifications as to the
conditions of submitted data, where required by order and where no
other cited or submitted study meets the data requirements the study
was intended to fulfill.

V. Statutory and Executive Order Reviews

    As required by statute, this proposal to require submission of data
in support of tolerances is in the form of an order and not a rule. (21
U.S.C. 346a(f)(1)(C)). Under the Administrative Procedures Act, orders
are expressly excluded from the definition of a rule. (5 U.S.C.
551(4)). Accordingly, the regulatory assessment requirements imposed on
rulemaking do not, therefore, apply to this action.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 22, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. 2010-18541 Filed 7-27-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Proposed Rules]
[Pages 76112-76115]
[FR Doc No: 2011-31183]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0881; FRL-9499-3]

Approval and Promulgation of Implementation Plans, State of
California, San Joaquin Valley Unified Air Pollution Control District,
New Source Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the San Joaquin
Valley Air Pollution Control District portion of the California State
Implementation Plan (SIP) submitted by the California Air Resources
Board. These revisions concern pre-construction review of new and
modified stationary sources (``new source review'' or NSR) within the
District. The revisions are intended to remedy deficiencies we
identified when granting limited approval and limited disapproval to
the rules in 2010, and to add NSR requirements for new major sources of
fine particulate matter (PM2.5) and major modifications at
existing major PM2.5 sources as required by the Clean Air
Act. We are taking comments on this proposal and plan to follow with a
final action.

DATES: Any comments must arrive by January 5, 2012.

ADDRESSES: Submit comments, identified by docket number EPA-R09-

OAR-2011-0881, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions.
     Email<EMAIL_ADDRESS>     Mail or deliver: Gerardo Rios (Air-3), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or email. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send email directly to EPA, your email address will be
automatically captured and included as part of the public comment. 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.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed in the
FOR FURTHER INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, Permits Office (AIR-
3), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Regulatory Context
II. The State's Submittals of Revised District Rules
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What are the purposes for revisions to these rules?
III. EPA's Evaluation and Action on the Revised Rules
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public comment and final action.
IV. Statutory and Executive Order Reviews

I. Regulatory Context

    On May 11, 2010 (75 FR 26102), we finalized a limited approval and
limited disapproval of San Joaquin Valley Unified Air Pollution Control
District (``SJVUAPCD'' or ``District'') Rules 2020 (Exemptions) and
2201 (New and Modified Stationary Source Review Rule), which were
submitted to EPA by the California Air Resources Board (CARB) to
satisfy certain applicable requirements under the Clean Air Act (CAA or
``Act''). These rules strengthened the SIP, but contained deficiencies
in enforceability that prevented full approval. Both rules contained
references to California Health and Safety Code (CH&SC) under
circumstances where the State law has not been submitted to EPA for
approval into the SIP and thereby unacceptably ambiguous.
    In our May 11, 2010 final rule, we explained that the District
could remedy these deficiencies by replacing the references to the
CH&SC with an unambiguous description of the agricultural sources
covered by the permitting exemption in Rule 2020 and the applicability
of the offset requirement to agricultural sources in Rule 2201, or by
submitting the State law provisions as a SIP revision. See 75 FR at
26106 (May 11, 2010). EPA is now proposing action on CARB's submittal
of new versions of Rules 2020 and 2201, which the District amended to
resolve the deficiencies we identified in our May 11, 2010 final rule.
    In a separate interim final action, published in the Rules section
in today's Federal Register, we are deferring sanctions that would
otherwise apply to the SJVUAPCD based on EPA's May 11, 2010 limited
approval and limited disapproval action on previous versions of
District Rules 2020 and 2201.
    In addition to addressing these deficiencies, we are also proposing
to approve revisions to Rule 2201 that address the 1997
p.m.2.5 standard. These revisions ensure that new major
sources of PM2.5, and major modifications at existing major
PM2.5 sources, will undergo pre-construction review that
requires permit applicants to apply Lowest Achievable Emission Rate
(LAER) and provide emission offsets.

II. The State's Submittals of Revised District Rules

A. What rules did the State submit?

    Table 1 lists the rules on which we are proposing action with the
dates that they were revised by the District and submitted to EPA by
CARB.

                                            TABLE 1--SUBMITTED RULES
----------------------------------------------------------------------------------------------------------------
            Local agency             Rule            Rule title              Amended        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD...........................            2020  Exemptions.................         8/18/11         9/28/11
SJVUAPCD...........................            2201  New and Modified Stationary         4/21/11        05/19/11
                                                      Source Review Rule.
----------------------------------------------------------------------------------------------------------------

    On October 25, 2011, we found that the submittal of District Rule
2020 and Rule 2201 met the completeness criteria in 40 CFR part 51,
appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    As discussed above, we approved versions of Rule 2020 and Rule 2201
into the SIP on May 11, 2010 (75 FR 26102). The amended versions of
Rule 2020, adopted by the District on August 18, 2011 and submitted to
us by CARB on September 28, 2011, and of Rule 2201, adopted by the
District on April 21, 2011 and submitted to us by CARB on May 19, 2011,
are the only revisions to the rule that the District has adopted since
our 2010 limited approval.

C. What are the purposes for revisions to these rules?

    Section 110(a) of the CAA requires states to submit regulations
that control volatile organic compounds, nitrogen oxides, particulate
matter, and other air pollutants which harm human health and the
environment. Permitting rules were developed as part of the local air
district's programs to control these pollutants.

    The purpose of District Rule 2020 (``Exemptions'') is to specify
emission units that are not required to obtain an Authority to
Construct or Permit to Operate. Rule 2020 also specifies the
recordkeeping requirements to verify such exemptions and outlines the
compliance schedule for emission units that lose the exemption.
    The purpose of District Rule 2201 (``New and Modified Stationary
Source Review Rule'') is to provide for the review of new and modified
stationary sources of air pollution and to provide mechanisms including
control technology requirements and emission trade-offs by which
Authorities to Construct such sources may be granted, without
interfering with the attainment or maintenance of ambient air quality
standards. District Rule 2201 is also intended to provide for no net
increase in emissions above specified thresholds from new and modified
stationary sources of all nonattainment pollutants and their
precursors.

III. EPA's Evaluation and Action on the Revised Rules

A. How is EPA evaluating the rules?

    The rules that are the subject of this proposed action amend rules
on which EPA has previously taken limited approval and limited
disapproval action. EPA previously took limited approval/limited
disapproval action on the rules because, while they met most of the
statutory and regulatory requirements for SIPs regarding minor NSR,
major nonattainment NSR, and enforceability of permit conditions, they
also contained certain unacceptably ambiguous provisions which
prevented full approval. Therefore, we have focused our review on the
changes in the rules that the District adopted to remedy the
deficiencies that we identified as well as those that the District has
newly introduced into the rules.
    The relevant statutory provisions for our review of the submitted
rules include CAA sections 110(a), 110(l), 172(c)(5) and 40 CFR 51.160-
165. Section 110(a) requires that SIP rules be enforceable, while
section 110(l) precludes EPA approval of SIP revisions that would
interfere with any applicable requirement concerning attainment and
reasonable further progress or any other applicable requirement of the
Act. Section 172(c)(5) requires SIPs with nonattainment areas to
require permits for the construction and operation of new or modified
major stationary sources in accordance with section 173, which
establishes, among other requirements, a control technology requirement
of ``lowest achievable emission rate'' (LAER) and an emissions offset
requirement for such new or modified stationary sources.
    Title 40, part 51, section 165 of title 40 of the Code of Federal
Regulations (40 CFR 51.165) establishes more specific requirements for
NSR SIPs to satisfy the requirements of sections 172(c)(5) and 173.
With respect to PM2.5 and its precursors, those
requirements, among others, include a new ``major source'' threshold of
100 tons per year, ``major modification'' thresholds of 10 tons per
year (direct PM2.5) or 40 tons per year for precursors
NOX and SO2, and an offset ratio of at least 1:1.
See 73 FR 28321 (May 16, 2008).

B. Do the rules meet the evaluation criteria?

    EPA found Rule 2020 deficient because the permitting exemption for
agricultural sources relied on a cross-reference to CH&SC Section
42301.16, which is not approved in the SIP and allows permitting
authorities to expand the universe of exempted sources if certain
findings are made in a public hearing, which would change the permit
exemption threshold without requiring SIP approval. To address this
deficiency, the District revised Rule 2020 by replacing the statutory
reference to CH&SC section 42301.16 with a clear description of the
sources covered by the exemption.
    In addition to resolving the deficiency, the District also added an
exemption for wind machines, and a definition of ``wind machine,'' to
Rule 2020. A wind machine consists of a large fan mounted on a tower
and powered by an internal combustion engine and used only on the
coldest winter nights to provide frost protection for certain type of
crops (like citrus) when temperatures are forecast to drop below
28[deg] F. Annual usage varies naturally with the frequency and
duration of cold spells in the San Joaquin Valley during any given
winter; however, the District estimates average annual use of any given
wind machine at 35 hours per year. Emissions per unit vary depending
upon the size of the engine used to power the fans and the fuel used to
power the engine, among other factors, but can reasonably be estimated
at approximately 15 pounds per day of NOX.\1\
---------------------------------------------------------------------------

    \1\ Most engines are fired on propane, although some are fired
on diesel. Some engines are electric, and have no emissions. Based
on a NOX emission factor for uncontrolled propane and use
of a 100-horsepower engine at 65% load from 8 p.m. to 7 a.m.: 100 hp
x 10 g NOX/bhp-hr x 0.65 x 11 hours/day/454 g/lb = 15.8
pounds per day per unit.
---------------------------------------------------------------------------

    We recognize that, when the applicable frost warnings occur, the
number of wind machines that operate all night long in certain parts of
the valley can number in the thousands, and that NOX
emissions during those particular nights are not necessarily
insignificant from the standpoint of PM10 and
PM2.5 formation, particularly in the San Joaquin Valley.
Nonetheless, we conclude that the permitting exemption for the wind
machines is acceptable because wind machines are not subject to any
prohibitory District rule,\2\ because no controls would approach any
reasonable threshold of cost-effectiveness given the very limited use
of the machines and the low emissions per unit, and because neither the
EPA-approved San Joaquin Valley PM10 maintenance plan nor
the EPA-approved PM2.5 attainment plan relies on emissions
reductions from this particular episodic source of emissions.
---------------------------------------------------------------------------

    \2\ See District Rule 4702 (``Internal Combustion Engines--Phase
2''), most recently approved by EPA at 73 FR 1819 (January 10,
2008).
---------------------------------------------------------------------------

    EPA found Rule 2201 deficient because the offset exemption for
minor agricultural sources was ambiguous because it relied on a cross-
reference to the CH&SC, rather than explicitly delineating the
exemption within the rule itself. The District remedied this deficiency
by replacing the CH&SC references with a clear description of the
applicability of the offset requirement to agricultural sources.
    The District also added requirements to Rule 2201 to address the
1997 p.m.2.5 standard. We have reviewed the PM2.5
provisions of the rule, including permitting thresholds, Best Available
Control Technology (which in California is the same as Federal LAER),
and emission offset requirements (including ratios based on distance
from the new or modified emission unit), and found that they satisfy
the CAA requirements for NSR for new and modified major stationary
sources of PM2.5.\3\
---------------------------------------------------------------------------

    \3\ While we believe that the District is appropriately
accounting for condensable particulate matter in regulating
PM2.5 from stationary sources, we recommend that District
rules be amended to be explicit regarding the inclusion of the
condensable portion of particulate matter in the definition of
PM2.5. See 40 CFR 165(a)(1)(xxxvii)(D). For example, the
District should amend the definition of ``PM2.5'' in Rule
2201, as has been done for the definition of ``PM10'' in
Rule 2201 to refer to Rule 1020 (``Definitions''), and then add a
definition of ``PM2.5'' in Rule 1020, as has been done
for ``PM10,'' that refers to applicable state and federal
test methods. Lastly, corresponding changes should also then be made
to section 5.0 (``Test Methods'') in District Rule 1081 (``Source
Sampling'') for PM2.5 in a similar manner as the District
has already done for PM10.
---------------------------------------------------------------------------

    CAA section 110(l) precludes EPA from approving SIP revisions that
would interfere with any applicable

requirement concerning attainment and reasonable further progress (RFP)
or any other applicable requirement of the Act. EPA has evaluated
amended Rules 2020 and 2201 and concluded that they would not interfere
with attainment and RFP for any of the NAAQS, and would not interfere
with any other applicable requirement of the Act. First, amended Rule
2201 does not relax the SIP in any aspect; rather, the amended rule
strengthens the SIP by applying NSR requirements to new or modified
major sources of PM2.5. Second, while amended Rule 2020
contains a new exemption for wind machines, this exemption would not
lead to an increase in emissions because, as explained above, wind
machines would not be subject to any particular controls under the NSR
rule even if no such exemption were in effect because no control device
would be considered cost-effective. Lastly, as noted above, neither the
EPA-approved San Joaquin Valley PM10 maintenance plan nor
the EPA-approved PM2.5 attainment plan relies on emissions
reductions from this particular episodic source of emissions. Thus, we
find the SIP revisions acceptable under CAA section 110(l).
    EPA's technical support document (TSD) for this rulemaking has more
information about these rules, including our evaluation and
recommendation to approve them into the SIP.

C. Public Comment and Final Action

    Because EPA believes the submitted rules fulfill all relevant
requirements, we are proposing to fully approve them as revisions to
the SIP pursuant to section 110(k)(3) of the Act. Specifically, we are
proposing to approve SJVUAPCD Rule 2020 (``Exemptions''), as amended by
the District on August 18, 2011 and submitted by CARB on September 28,
2011; and SJVUAPCD Rule 2201 (``New and Modified Stationary Source
Review Rule''), as amended by the District on April 21, 2011 and
submitted by CARB on May 19, 2011, as revisions to the California SIP.
In so doing, we conclude that the District has remedied deficiencies
that EPA had identified in previous versions of the rules and that
other changes made by the District to the rules meet the applicable NSR
requirements of the Act and our regulations.
    We will accept comments from the public on this proposal for the
next 30 days. Unless we receive convincing new information during the
comment period, we intend to publish a final approval action that will
incorporate these rule(s) into the federally enforceable SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves State law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by State law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     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);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements.

    Dated: November 22, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-31183 Filed 12-5-11; 8:45 am]
BILLING CODE 6560-50-P