[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Rules and Regulations]
[Page 66916-66921]
[DOCID:fr17de09-6]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2009-0359; FRL-8983-4]

Approval and Promulgation of Air Quality Implementation Plans;
California; Monterey Bay Region 8-Hour Ozone Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Direct final rule.

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SUMMARY: EPA is taking direct final action to approve a revision to the
Monterey Bay Area portion of the California State Implementation Plan.
Submitted by the California Air Resources Board on December 19, 2007,
this plan revision consists of a maintenance plan prepared for the
purpose of providing for continued attainment of the 8-hour ozone
standard in Monterey Bay through the year 2014 and thereby satisfying
the related requirements under Section 110(a)(1) of the Clean Air Act
and EPA's phase 1 rule implementing the 8-hour ozone national ambient
air quality standard. EPA is taking this action pursuant to those
provisions of the Clean Air Act that obligate the Agency to take action
on submittals of state implementation plans and plan revisions.

DATES: This rule is effective February 16, 2010 without further notice,
unless EPA receives relevant adverse comment by January 19, 2010. If
EPA receives such comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that this rule will not take
effect.

ADDRESSES: Submit your comments, identified by [EPA-R09-OAR-2009-0359]
by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     E-mail: Sarvy Mahdavi at<EMAIL_ADDRESS>Please
also send a copy by e-mail to the person listed in the FOR FURTHER
INFORMATION CONTACT section below.
     Fax: Sarvy Mahdavi, Planning Office (AIR-2), at fax number
(415) 947-3579.
     Mail or deliver: Sarvy Mahdavi, Air Planning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne
Street, San Francisco, California 94105-3901. Hand or courier
deliveries are accepted only between the hours of 8 a.m. and 4 p.m.
weekdays except for legal holidays. Special arrangements should be made
for deliveries of boxed information.

    Instructions: 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 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 http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site 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 http://
www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Planning Office
(AIR-2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne
Street, San Francisco, California 94105-3901. 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.

FOR FURTHER INFORMATION CONTACT: Sarvy Mahdavi, Planning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX, 75 Hawthorne
Street, San Francisco, California 94105-3901, telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA. This supplementary information is
organized as follows:

Table of Contents

I. Summary of Action
II. Background
    A. Regulatory Context
    B. Ambient Ozone Conditions
III. Evaluation of State's Submittal
    A. CAA Procedural Requirements
    B. Evaluation of Ozone Maintenance Plan
    1. Attainment Inventory
    2. Maintenance Demonstration
    3. Ambient Air Quality Monitoring
    4. Verification of Continued Attainment
    5. Contingency Plan
    6. Conclusion
IV. Final Action and Request for Comment
V. Statutory and Executive Order Reviews

I. Summary of Action

    On December 19, 2007, the California Air Resources Board (CARB)
submitted to EPA, for approval as a revision to the California State
Implementation Plan (``SIP''), the 2007 Federal Maintenance Plan for
Maintaining the National Ozone Standard in the Monterey Bay Region
(``Monterey Maintenance Plan'' or ``Ozone Maintenance Plan''). The
Monterey Maintenance Plan was developed by the Monterey Bay Unified Air
Pollution Control District (``MBUAPCD'' or ``Monterey Bay'' or ``the
District'') and adopted by the District on March 21, 2007. MBUAPCD
prepared the plan to provide for continued attainment of the 8-hour
ozone national ambient air quality standard (NAAQS) through 2014 and to
thereby satisfy the requirements of section 110(a)(1) of the Clean Air
Act (``CAA'' or ``the Act'') and EPA's Phase 1 Rule for implementation
of the 1997 8-hour ozone NAAQS (see 69 FR 23951), also known as ``the
Phase 1 Implementation Rule.'' The December 19, 2007 SIP revision
submittal includes the maintenance plan and related technical
appendices, as well as documentation of notice, public hearing, and
adoption by the District.
    For the reasons set forth in this document, and pursuant to section
110(k) of the Act, we are approving the Ozone Maintenance Plan as a
revision to the Monterey Bay portion of the California SIP.
    In so doing, we find that the submitted ozone maintenance plan
meets all of the applicable requirements of CAA section 110(a)(1) and
our Phase 1 Implementation Rule.

II. Background

A. Regulatory Context: Monterey Bay Designation, Classification, SIPs,
and Attainment

    Under the Clean Air Act (CAA) as amended in 1970, EPA established
national ambient air quality standards (NAAQS) for certain pervasive
air pollutants, such as photochemical oxidant, carbon monoxide, and
particulate matter. The NAAQS represent concentration levels below
which public health and welfare are protected. The 1970 Act also
required States to adopt and submit State Implementation Plans (SIPs)
to implement, maintain, and enforce the NAAQS.
    EPA approved the original California SIP in 1972 (see 37 FR 10850).
SIP revisions are required from time-to-time to account for new or
amended NAAQS or to meet other changed circumstances. The CAA was
significantly amended in 1977, and under the 1977 Amendments, EPA
promulgated attainment status designations for all areas of the country
with respect to the NAAQS.
    The CAA requires EPA to periodically review and revise the NAAQS,
and in 1979, EPA established a new NAAQS of 0.12 ppm for ozone,
averaged over 1 hour. This new NAAQS replaced the oxidant standard of
0.08 ppm. See 44 FR 8202 (February 8, 1979). Areas designated
nonattainment for oxidant were considered to be nonattainment for ozone
as well, but States could request redesignation to attainment if
monitoring data showed that an area met the ozone NAAQS.
    Congress significantly amended the CAA again in 1990. Under the
1990 Amendments, each area of the country that was designated
nonattainment for the 1-hour ozone NAAQS, including the Monterey Bay
Area, was classified by operation of law as marginal, moderate,
serious, severe, or extreme nonattainment depending on the severity of
the area's air quality problem. The ozone nonattainment designation for
the Monterey Bay Area continued by operation of law according to
section 107(d)(1)(C)(i) of the CAA, as amended in 1990. Furthermore,
the area was classified by operation of law as moderate for ozone under
section 181(a)(1). See 40 CFR 81.305 and 56 FR 56694 (November 6,
1991).
    On July 14, 1994, California requested redesignation of the
Monterey Bay Area to attainment with respect to the 1-hour ozone NAAQS
and submitted an ozone maintenance SIP for the area.
    EPA promulgated the 8-hour ozone NAAQS in 1997 (see 62 FR 38894
(July 18, 1997), and designated and classified

areas for this standard in 2004 (see 69 FR 23857, April 30, 2004). On
January 17, 1997, EPA redesignated the Monterey Bay Area from
nonattainment to attainment for 1-hour ozone. EPA also approved the
Monterey Bay Area Maintenance Plan, 1990 base year inventory, emission
statement rule, volatile organic compound (VOC) reasonably available
control technology (RACT) rule 419 and oxides of nitrogen
(NOX) RACT rule 431 as revisions to California's SIP for
ozone. See 62 FR 2597 (January 17, 1997).
    Effective June 15, 2004, EPA designated the Monterey Bay Area as
unclassifiable/attainment for the 8-hour Ozone NAAQS. See 69 FR 23890
(April 30, 2004).
    Effective June 15, 2005, EPA revoked the pre-existing 1-hour NAAQS.
See 69 FR 23951 (April 30, 2004). As part of this rulemaking, EPA also
established certain requirements to prevent backsliding in those areas
that were designated as nonattainment for the 1-hour ozone standard (or
that were redesignated to ``attainment'' but subject to a maintenance
plan, as is the case for the Monterey Bay Area) at the time of
designation for the 8-hour ozone standard. These requirements are
codified at 40 CFR 51.905.

B. Ambient Ozone Conditions

    Monterey Bay currently monitors ozone at nine locations: Pinnacles
National Monument (NM), Hollister, Scotts Valley, Carmel Valley,
Salinas, King City, Watsonville, Santa Cruz, and Davenport. The
District operates seven of these stations located in populated areas.
The National Parks Service operates the station at Pinnacles NM, while
an industry consortium operates the King City station. All monitors are
State and Local Air Monitoring Stations (SLAMS), with the exception of
Pinnacles and Davenport, which are Special Purpose Monitors (SPMs).
    The current ozone NAAQS is met at an ambient air quality monitoring
site when the three-year average of the annual fourth-highest daily
maximum 8-hour ozone concentration (also referred to as the ``design
value'') is less than or equal to 0.08 ppm, and the standard is met
within an air quality planning area when the standard is met at all of
the monitoring sites.
    A review of the data gathered at the various ozone monitoring sites
in the Monterey Bay Area, and entered into AQS, confirms that the
Monterey Bay Area is in attainment of the 8-hour ozone NAAQS. Since
1999, the highest design value at any of the ozone monitoring sites was
0.081 ppm, a value calculated for the Pinnacles NM monitor over the
2001-2003 period. The following table shows design values for EPA's
2001-2003 designation period for all nine stations in Monterey Bay
monitoring network:

------------------------------------------------------------------------
                                        Design
               Station                  value        Within standard?
                                        (ppm)
------------------------------------------------------------------------
Pinnacles...........................      0.081  Yes.
Hollister...........................      0.073  Yes.
Carmel Valley.......................      0.066  Yes.
Scotts Valley.......................      0.065  Yes.
King City...........................      0.062  Yes.
Salinas.............................      0.059  Yes.
Watsonville.........................      0.057  Yes.
Santa Cruz..........................      0.056  Yes.
Davenport...........................      0.052  Yes.
------------------------------------------------------------------------

     Based on the rounding convention in 40 CFR part 50, design values
less than or equal to 0.084 ppm meet the ozone NAAQS. More recently,
data through 2005 indicate that all stations continue to have design
values within the standard.

III. Evaluation of State's Submittal

    As noted above, EPA promulgated the 8-hour ozone NAAQS in 1997 and
designated and classified areas for this standard in 2004. Additionally
in 2004, as previously mentioned, EPA also published the Phase 1 Ozone
Implementation Rule. See 40 CFR part 51, subpart X. Section
51.905(a)(3) and (4) established requirements for anti-backsliding
purposes for areas designated unclassifiable/attainment for the 8-hour
standard.
    These provisions required States with such areas to submit 10-year
maintenance plans under Section 110(a)(1) of the CAA if they were also
nonattainment areas (or were attainment areas subject to a CAA section
175A maintenance plan) under the 1-hour ozone standard. Such plans were
to be submitted as revisions to SIPs. MBUAPCD prepared this Ozone
Maintenance Plan because it is an area designated unclassifiable/
attainment for the 8-hour standard and an attainment area subject to a
CAA section 175A maintenance plan under the 1-hour standard. See 40 CFR
51.905(a)(4).
    EPA provided guidance to States regarding section 110(a)(1) ozone
maintenance plans in a memorandum from Lydia N. Wegman, Director, Air
Quality Strategies and Standards Division, EPA Office of Air Quality
Planning and Standards, entitled, ``Maintenance Plan Guidance Document
for Certain 8-hour Ozone Areas Under Section 110(a)(1) of the Clean Air
Act,'' dated May 20, 2005 (``Wegman Memorandum''). For the contingency
plan element of section 110(a)(1) maintenance plans, the Wegman
Memorandum cites an EPA policy memorandum from John Calcagni, entitled,
``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' dated September 4, 1992 (``Calcagni Memorandum'').

A. CAA Procedural Requirements

    Under Section 110 of the Act and EPA regulations (at 40 CFR Part
51, Subpart F), each State must provide reasonable notice and public
hearing prior to adoption of SIPs and SIP revisions for subsequent
submittal to EPA.
    On March 13, 2007, the MBUAPCD published a public hearing
announcement in the area's four largest newspapers. The public hearing
was held at an MBUAPCD Board of Directors meeting on March 21, 2007.
The Ozone Maintenance Plan was presented in the meeting as Agenda Item
17; there were no public comments and the plan was approved by
unanimous vote of the Board.

B. Evaluation of Ozone Maintenance Plan

    The 8-hour ozone 110(a)(1) maintenance plan must provide for
continued maintenance of the 8-hour ozone NAAQS in the area for 10
years from the effective date of the area's designation as
unclassifiable/attainment for the 8-hour ozone NAAQS. At a minimum, the
maintenance plan for such areas must include the five following
components: Attainment inventory, maintenance demonstration, ambient
air quality monitoring, verification of continued attainment, and
contingency plan. See Wegman Memorandum.
    As explained below, we find that the Monterey Maintenance Plan
includes all five required components of a maintenance plan, that each
component is acceptable, and that the overall plan provides for
continued maintenance of the 8-hour ozone NAAQS in the Monterey Bay
Area through 2014 (i.e., 10 years beyond 2004, the year of the area's
designation for the 8-hour ozone NAAQS).
1. Attainment Inventory
    The attainment inventory should be based on actual ``typical summer
day'' emissions of Volatile Organic Compounds (VOCs) and Oxides of
Nitrogen (NOX). EPA's Phase 1 Implementation Rule provides
that the 10-year maintenance period begins as of the effective date of
the area's designation for the 8-hour ozone standard. For purposes of
an attainment emissions inventory, the State may use one of any of the
three years on which

the 8-hour attainment designation was based (i.e., 2001, 2002, and
2003). The inventory should be consistent with EPA's most recent
emissions inventory methods, models, and factors, and should be based
on the latest planning assumptions regarding population, employment,
and motor vehicle activity. See Wegman Memorandum at 4; Calcagni
Memorandum at 8.
    The Monterey Maintenance Plan includes an emissions inventory of
VOCs and NOX for the years 1990 to 2030. The inventory was
based on CARB's Version 1.06 8-hour Ozone SIP Emission Inventory
Projections, which include CARB and District emissions inventory data
for stationary and area sources. The mobile source emissions inventory
was based on CARB's draft EMFAC 2007 Version 2.3 emission model for on-
road motor vehicles and CARB's draft OFFROAD 2007 model for off-road
sources.
    Based on our review of the documentation submitted, EPA concludes
that the attainment inventory has been developed for the appropriate
season of an acceptable attainment year, is comprehensive and based on
appropriate factors and methods, and is thus acceptable for the
purposes of a section 110(a)(1) ozone maintenance plan.
2. Maintenance Demonstration
    The key element of a section 110(a)(1) ozone maintenance plan is a
demonstration of how the area will remain in compliance with the 8-hour
ozone standard for the 10-year period following the effective date of
designation as unclassifiable/attainment. The end projection year is 10
years from the effective date of the 8-hour attainment designation,
which for the Monterey Bay Area was June 15, 2004. Therefore, this plan
must demonstrate attainment through year 2014. See Wegman Memorandum at
4.
    The typical method that areas have used in the past to demonstrate
an area will maintain the 1-hour ozone standard has been to identify
the level of ozone precursor emissions in the area which is sufficient
to attain the NAAQS and to then show that future emissions of ozone
precursors will not exceed the attainment levels. To perform this
analysis, for the 8-hour maintenance plan, the State must develop
emissions inventories for the attainment year and for the projection
year. See Wegman Memorandum at 4.
    Additionally, because the plan must demonstrate maintenance
throughout the applicable 10-year period, not just in the projection
year, the State must develop an emissions inventory for an interim year
between the attainment inventory year and the projection inventory year
to show a trend analysis for maintenance of the standard. See Wegman
Memorandum at 5.
    The Monterey Maintenance Plan includes emissions inventories of
ozone precursors for interim years (every year from 2005 through 2014),
and the projection year (2014). To develop the emissions projections
for the future years, Monterey Bay continued the declining trend
forward based on historical trends in the inventory. The reductions in
emissions are attributed to stationary and mobile source measures
adopted and implemented throughout the Monterey Bay Area and
California. These measures include statewide mobile source measures and
the District's prohibitory regulations for stationary source
operations, such as solvents and coating operations and petroleum
production and processing. See MBUAPCD Agency-wide SIP regulations at
http://yosemite.epa.gov/R9/r9sips.nsf/
Agency?ReadForm&count=500&state=California&cat=Monterey+Bay+Unified+APCD
-Agency-Wide+Provisions.
    As noted above, Monterey Bay's inventory is based on CARB's Version
1.06 8-hour Ozone SIP Emission Inventory Projections, which include
CARB and District emissions inventory data for stationary and area
sources. The mobile source emissions inventory was based on CARB's
draft EMFAC 2007 Version 2.3 emission model for on-road motor vehicles
and CARB's draft OFFROAD 2007 model for off-road sources. EPA has
concluded that these inventory projections are comprehensive, based on
appropriate factors and methods, and thus acceptable for the purposes
of a section 110(a)(1) ozone maintenance plan.
3. Ambient Air Quality Monitoring
    Generally, EPA determines whether an area's air quality is meeting
the NAAQS based upon data gathered at established State and local air
monitoring stations (SLAMS) and national air monitoring sites (NAMS)
and entered into the Air Quality Systems (AQS) database. Data entered
into AQS has been determined to meet Federal monitoring requirements
(see 40 CFR part 50.6; 40 CFR part 50, appendix J; 40 CFR part 53; 40
CFR part 58, appendices A and B) and may be used to determine the
attainment status of areas. We also take into account data from other
air monitoring stations, such as Special Purpose Monitors (SPMs), if
the data is collected using a Federal reference method or Federal
equivalent method, unless the air monitoring agency demonstrates that
the data came from a particular period during which EPA requirements
concerning quality assurance, methods, or siting criteria were not met
in practice. See 71 FR 61236, at 61302 (October 17, 2006) and 40 CFR
58.20. EPA reviews all data to determine the area's air quality status
in accordance with 40 CFR part 50, appendix I.
    On May 5, 2008, EPA approved the District's Annual Network Plan
submitted on July 1, 2007 for ozone monitoring stations, based on a
determination that the MBUAPCD's ozone monitoring network met the
applicable requirements of 40 CFR Part 58. See 2006 Ambient Air
Monitoring Network Plan submitted on July 1, 2007, and Letter dated May
5, 2008, from EPA Region 9 (Sean Hogan) to MBUAPCD (Douglas Quetin)
approving MBUAPCD's 2006 Ambient Air Monitoring Network Plan.
    The State should continue to operate air quality monitors in
accordance with 40 CFR part 58 to verify maintenance of the 8-hour
ozone standard in the area. Monterey Bay currently monitors ozone at
nine locations. In the Ozone Maintenance Plan, the District commits to
continue operating an appropriate ozone monitoring network in
accordance with the requirements of 40 CFR part 58 to verify the
attainment status of the area. See Ozone Maintenance Plan at 6.
4. Verification of Continued Attainment
    A Section 110(a)(1) ozone maintenance plan should indicate how the
State will track the progress of the maintenance plan. This is
necessary due to the fact that emissions projections made for the
maintenance demonstration depend on assumptions of point, area, and
mobile source activity and turn-over rates. One option for tracking the
progress of the maintenance demonstration would be for the State to
periodically update the emissions inventory. See Wegman Memorandum at
5.
    To ensure continued attainment, the District commits to continue
ambient monitoring and to periodically update the emissions inventory.
More specifically, the stationary source emission inventory is updated
annually; the mobile source inventory is updated every two years or as
updates to the mobile source emissions models (EMFAC and OFFROAD)
issued by CARB; and the entire inventory and forecasts, including
stationary, area, and mobile categories, are updated by the CARB and
District every three years. See Ozone Maintenance Plan at 11.

5. Contingency Plan
    EPA's Phase 1 Implementation Rule requires section 110(a)(1)
maintenance plans to include contingency provisions to promptly correct
any violation of the ozone NAAQS that occurs. Generally, contingency
plans should clearly identify measures to be adopted, a schedule and
procedure for adoption and implementation, and a specific timeline for
action by the State. Also, the State should identify specific
indicators or triggers, which will be used to determine when the
contingency measures need to be implemented. See Calcagni Memorandum at
12, 13.
    The Monterey Maintenance Plan includes a contingency plan that
establishes two elements: Contingency triggers, which would be used to
implement measures should air quality in the area approach the level of
the Federal standard; and contingency measures, which are templates for
adoption of future rules.
    Monterey Bay's contingency triggers have two components: An
inventory trigger and an ambient trigger, which can both be activated
prior to the area violating the standard. The inventory trigger is
designed to prevent emissions from exceeding the levels identified in
the 2002 Maintenance Inventory. This trigger would be met if emissions
are forecast to reach 95% of the levels in the Maintenance Inventory.
Based on the current inventory, this threshold would be 90.4 tons per
day for VOC and 79.1 tons per day for NOX.
    The second contingency trigger, the ambient trigger, was developed
based on a review of historical air monitoring data. This trigger would
be met if the average of the fourth highest annual concentration for
the two most recent years of complete data from the highest station
reached 0.085 ppm or higher. Implementation of the contingency plan
would be discontinued if ambient air monitoring data for the third year
indicated the area would not violate the standard.
    Monterey has 16 contingency measures, 2 of which are based on
locally adopted rules that would require rule revision, while the
remaining 14 require adoption of new rules.
    The following measures require revisions to locally adopted rules:
(1) Fixed and Floating Roof Petroleum Storage Tanks (District Rule
417)--requires tight-fitting secondary seals on most floating-roof
storage tanks which will exert a pressure of 30 psi on the wall of the
tank. Estimated control efficiency is about 75% and the cost-
effectiveness is $15,000 to $50,000 per ton reduced. (2) Metal Parts
and Products (District Rule 434)--reduction of VOC emissions from
coating of metal parts and products. Estimated control efficiency is
30% and cost effectiveness is $5,000 to $20,000 per ton reduced.
6. Conclusion
    Based on our review of the submitted plan, we are approving the
Monterey Maintenance Plan as a revision to the Monterey Bay portion of
the California SIP. In so doing, we find that the Monterey Maintenance
Plan, submitted to EPA by CARB on December 19, 2007, satisfies the
requirements of CAA section 110(a)(1) and EPA's Phase 1 Implementation
Rule.

IV. Final Action and Request for Comment

    Under section 110(k) of the Clean Air Act, EPA is approving a
revision to the Monterey Bay portion of the California SIP that was
submitted to EPA on December 19, 2007 and that consists of the 2007
Federal Maintenance Plan for the Monterey Bay Region 8-Hour Ozone
Attainment Area ``Monterey Maintenance Plan'' or ``Ozone Maintenance
Plan''. As described in more detail above, we are approving the
Monterey Bay Ozone Maintenance Plan because we find that it provides
for continued attainment of the 8-hour ozone standard in the Monterey
Bay Area through the year 2015 and thereby satisfies the related
requirements under section 110(a)(1) of the Clean Air Act and EPA's
Phase 1 Implementation Rule. Our approval of the Monterey Maintenance
Plan as a revision to the California SIP makes the commitments included
therein, such as those related to ambient air quality monitoring,
verification of continued attainment, and the contingency plan,
Federally enforceable.
    EPA is publishing this rule without prior proposal because we view
this as a non-controversial action and anticipate no adverse comments.
However, in the proposed rules section of this Federal Register
publication, we are publishing a separate document that will serve as
the proposal to approve the SIP revision if relevant adverse comments
are received. This rule will be effective on February 16, 2010 without
further notice unless we receive adverse comments by January 19, 2010.
If we receive adverse comments, we will publish a timely withdrawal in
the Federal Register informing the public that the rule will not take
effect. We will address all public comments in a subsequent final rule
based on the proposed rule. We will not institute a second comment
period on this action. Any parties interested in commenting must do so
now. Please note that if we receive adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, we may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

V. 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 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 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, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible

methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this 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.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 16, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the proposed
rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that EPA can withdraw this direct final rule and address the comment in
the proposed rulemaking. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: November 6, 2009.
Jane Diamond,
Acting Regional Administrator, Region IX.

0
Chapter I, title 40 of the Code of Federal Regulations is amended as
follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

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

Subpart F--California

0
2. Section 52.220 is amended by adding paragraph (c)(367) to read as
follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (367) The following plan was submitted on December 19, 2007, by the
Governor's Designee.
    (i) [Reserved]
    (ii) Additional material.
    (A) Monterey Bay Unified Air Pollution Control District (MBUAPCD).
    (1) 2007 Federal Maintenance Plan for Maintaining the National
Ozone Standard in the Monterey Bay Region (Monterey Maintenance Plan),
excluding Appendix A.
    (2) MBUAPCD Board of Directors Certified Minutes and Resolution
dated March 21, 2007, adopting the Monterey Maintenance Plan.
    (3) Letter dated May 10, 2007, from Association of Monterey Bay
Area Governments (AMBAG) to MBUAPCD, confirming AMBAG's approval of the
Monterey Maintenance Plan on May 9, 2007.
    (4) California Air Resources Board Executive Order  G-07-
68, dated December 19, 2007, adopting the Monterey Maintenance Plan.
* * * * *

0
3. Section 52.282 is amended by adding paragraph (b) to read as
follows:

Sec.  52.282  Control strategy and regulations: Ozone

* * * * *
    (b) Approval. On December 19, 2007, the California Air Resources
Board submitted a maintenance plan for the 1997 8-hour ozone NAAQS for
the Monterey Bay Area as required by section 110(a)(1) of the Clean Air
Act, as amended in 1990, and 40 CFR 51.905(a)(4). Elements of the
section 110(a)(1) maintenance plan for ozone include a base year (2002)
attainment emissions inventory for ozone, a demonstration of
maintenance of the ozone NAAQS with projected emissions inventories
through the year 2014 for ozone, a plan to verify continued attainment,
and a contingency plan. The maintenance plan meets the Federal
requirements of Clean Air Act section 110(a)(1) and 40 CFR 51.905(a)(4)
and is approved as a revision to the California State Implementation
Plan for the above mentioned area.

[FR Doc. E9-29891 Filed 12-16-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: May 5, 2006 (Volume 71, Number 87)]
[Notices]
[Page 26488]
[DOCID:fr05my06-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-317-000]

Transcontinental Gas Pipe Line Corporation; Notice of Proposed
Changes in FERC Gas Tariff

April 27, 2006.
    Take notice that on April 24, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, Eighteenth Revised Sheet No. 250
and Ninth Revised Sheet No. 344 to become effective May 24, 2006.
    Transco states that the purpose of this filing is to add section
31, Waiver, to the General Terms and Conditions of its Tariff. Proposed
section 31 allows Transco to waive its rights and shippers' obligations
under Transco's tariff on a not unduly discriminatory basis to resolve
unique, temporary problems that may arise from time to time. In
accordance with the Standards of Conduct, Transco would keep a log
detailing the circumstances and manner in which it exercised discretion
under section 31 and post such information on its 1Line Internet Web
site.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6831 Filed 5-4-06; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM FROM: William L. Jordan Senior Policy Adviser Office of Pesticide Programs ( 7501P)

TO: Paul I. Lewis Designated Federal Official for the Human Studies Review Board Office of the Science Adviser SUBJECT: OPP Comments on the Draft Report of the April 4   6, 2006, Meeting of the Human Studies Review Board We appreciate the opportunity to offer comments on the draft report on the first meeting of the Human Studies Review Board ( HSRB), held April 4   6, 2006. In general, the report reflects the oral comments made during the meeting and provides useful additional clarifications. We also thank the Board members for the extraordinary efforts they made to prepare for the meeting, to provide such useful commentary, and to produce a completed report so soon after the meeting.

Staff in the Office of Pesticide Programs ( OPP) has carefully reviewed the draft to identify any portions that are either unclear or inconsistent with our notes from the meeting. In addition, OPP has identified places in the text of the draft report that appear to contain typographical or other minor editorial errors.

This memorandum does not purport to state how EPA plans to act on the HSRB's recommendations. We will report to the Board at a future meeting how OPP has acted on its recommendations.

Major comments OPP has major comments on the portions of the report dealing with amitraz and azinphos methyl.

1. Amitraz The Board's recommendations concerning the use of the results of the available human studies on amitraz appear to be inconsistent. On page 5, the HSRB states in the summary section for amitraz under Scientific Considerations:

" The results from the single oral dose study are informed by the human metabolism study such that the single oral dose study is appropriate for developing a point of departure for acute and chronic dietary risk and short term oral exposure." and later on the same page:

" The combined results from the single oral dose study and the human metabolism study were not appropriate for developing a point of departure for chronic dietary risk, short term oral exposure, or inhalation risk."

Substantively identical statements appear in the body of the report on p. 62. These two statements appear to contradict each other with respect to whether the combined results from the two amitraz studies may be used for developing a point of departure for chronic dietary risk and short term oral exposure.

Based on the rationale presented in the body of the report, we surmise that the Board may have meant to say that the available human studies could be used for acute dietary risk assessment, but should not be used to develop a point of departure for exposure intervals longer than one day, i. e., for chronic dietary risk, short term oral exposure, and inhalation risk. In its explanation for the recommendation not to use the amitraz data for assessing the risk of chronic dietary exposure, the Board cited the possibility that amitraz may not be fully eliminated from the body in one day, and thus that the effects produced by the single, higher dose of amitraz used in the metabolism study might occur if a lower dose of amitraz, such as that used in the single oral dose study, were repeated on successive days.

As reflected in OPP's Weight of Evidence assessment, EPA and the Board reached essentially the same conclusions with respect to using the available amitraz human studies to derive a point of departure for acute dietary risk. If it is correct that the Board recommends not using the human data for the chronic dietary risk, short term oral exposure and inhalation exposure, it should be noted that OPP's WOE assessment reached a different conclusion. OPP agrees with the Board's observations that the available human studies only provide insights into how humans respond to a single dose of amitraz, and that the human studies, by themselves, do not contain data to characterize the effects of multiple days of exposure.

OPP's WOE, however, concluded on the basis of the available animal toxicity data, together with human incident information, that there is no appreciable difference between the levels of toxicity displayed in single vs. multiple day exposures. Further, OPP believes that the draft report may overstate the conclusions to be drawn from the amitraz metabolism. On p. 62, line 32, the draft report states: " Excretion of radiolabeled metabolites was incomplete ( 62%) at 24 hours." The metabolism study did report that 62% of the radioactivity was detected in urine collected at the end of 24 hours. While the study could not account for the remainder of the radioactivity, OPP believes that the data do not show that 38% of the radioactivity was retained by the subjects, especially since there were no measurements of radioactivity in either feces or expired air ( which would show excretion) or blood ( which would show retention). Thus, the metabolism study leaves considerable uncertainty about the extent of excretion of a single oral dose of amitraz over a 24 hour period. In OPP's view, this uncertainty is sufficiently offset by the evidence from animal toxicity testing and human incidents showing comparability in toxicity between single and multiple day exposures to justify the use of the human studies for chronic dietary, short term oral, and inhalation risk assessments.

2. Azinphos methyl OPP has concerns about a portion of the draft report discussing the possible causes of symptoms experienced by subjects in the 28 day oral dosing study with azinphos methyl ( AZM). On p. 34, lines 39  42, the report states:

A variety of symptoms were reported over the course of the study, with the majority occurring in the subjects administered AZM. The conclusion drawn in the Agency's Data Evaluation Record ( Doherty 1999) that none of the symptoms likely reflected effects of AZM is not verifiable, nor is it credible.

OPP recognizes that the data available from the 28 day oral dosing study are insufficient to show definitively whether AZM did or did not cause the reported symptoms, and therefore acknowledges the Board's advice that no firm conclusion should be reached on their causation. We are concerned, however, with the characterization of the conclusions reached by EPA's science reviewer.

We suggest the following:

A variety of symptoms consistent with cholinesterase inhibition were reported in both the control ( 2 of 4 subjects, 17 events) and AZM dosed groups ( 8 of 8 subjects, 53 events) over the course of the study. There was, however, no statistically significant decrease in cholinesterase activity detected in AZMtreated subjects; no increase in the severity of the symptoms reported by the treatment group, as compared to the control group; and the symptoms in the AZM treated group did not grow worse over time as exposure continued. While the study report asserted that AZM did not cause these symptoms, there was insufficient information to support that conclusion and some concern within the Board that some of the symptoms could have resulted from AZM treatment.

Minor Comments EPA has the following minor comments:

P. 1, line 28 ( and elsewhere): Throughout the document the report refers to sodium cyanide and hydrogen cyanide in ways that may confuse the reader. The registered pesticide product contains the active ingredient, sodium cyanide. When mixed with water, the pesticide produces hydrogen cyanide, the active compound. The studies reviewed by the Board involved amygdalin, which breaks down into hydrogen cyanide in vivo. Refer, e. g., to p. 4, lines 41, 45; p. 5, line 2; p. 54, line 32.

p. 1, line 25: revise to read: ". . . procedures that could have resulted . . . ." p. 1, line 28: change the tense of verbs, " proposes" to " proposed".

p. 2, line 4 ( and elsewhere): The standard of proof for rejecting a study conducted before April 7 requires " clear and convincing evidence that the conduct of the research was fundamentally unethical . . . ." ( emphasis added). The draft report inaccurately quotes the standard as " clear or convincing evidence."

p. 2, line 35: Change to read " affected the outcome or conclusions of this study."

p. 4, line 20 21: Revise to read " the scientific quality of either the ethephon 28 day oral toxicity study or the ethephon 16 day human oral toxicity study . . . ."

p. 11, line 3: Cite the final rule as ( 71 Federal Register 6137).

p. 11, line 11: Delete repetitive language " the first meeting of the Board".

p. 11, line 27: The Emanuel ( 2000) article does not appear in the list of references at the end of the draft report. The full citation is " Emanuel, E.; Wender, D.; Grady, C. ( 2000) What Makes Clinical Research Ethical? JAMA 283: 2701 2711."

p. 11, line 35: Delete " has". The purpose of this and similar changes is to make clearer that the report reflects the Agency's position at the time of the meeting, as opposed to the time of the report.

p. 12, lines 4  5: Revise to read ". . . on which the Agency proposed to rely in actions under the pesticide laws and studies the Agency had decided not to use . . . ."

p. 12, line 19: Cite the Notice as ( 71 Federal Register 12,194).

p. 12, lines 27 and 30: Should the " i. e.," be " e. g.,"?

p. 12, line 33: Insert a right parenthesis after the word " consent."

p. 13, lines 37  41: Revise to read ". . . for aldicarb described the study design . . . . The WOE document also discussed . . . . Regarding the aldicarb human study, the Agency concluded . . . ."

p. 20, lines 34  35: Revise to read ". . . and the criterion not to escalate the dose when inhibition of RBC cholinesterase exceeded 40%."

p. 25, line 23: Revise to read " DER for oxamyl described the study . . . ."

p. 26, line 21: Revise to read " In its policy on the use . . . ." p. 26, lines 24 5: Revise to read " as a surrogate for effects on the peripheral nervous system in animals and for effects on the peripheral and central nervous systems in humans."

p. 26, line 42: Revise to read ". . . dosing was described in the protocol."

p. 27, line 3: Revise to read " baseline in RBC and plasma . . . ."

p. 28, line 8: Insert concluding period.

p. 29, line 21: The correct reference is Carley 2006c.

p. 31, lines 32  36: The observation that the informed consent materials described cholinesterase inhibition as a side effect of exposure is made twice in this passage.

p. 33, line 30: Revise to read ". . . based on the results of a subchronic rat study and an earlier study . . . ."

p. 33, line 32: Revise to read ". . . and regulatory agencies were reluctant to . . . ."

p. 34, line 9: Revise to read ". . . chosen to reduce the likelihood of confounding factors."

p. 34, line 23: Replace terminal parenthesis with colon.

p. 34, line 26: Revise to read " Comparison of same day predosing ChE activities with ChE activities 4 hours after dosing". ( No inhibition was observed.)

p. 34, line 31: Revise to read " . . . however there have been no consistent sex differences in sensitivity with regard to inhibition of plasma or RBC cholinesterase in animal studies." ( At higher dose levels that elicit more serious toxicity, there gender related differences in responses.)

p. 35, lines 21  22: Revise to read: ". . . in other studies of carbamates and organophosphates." The laboratory which conducted the AZM study had performed human research on the cholinesterase inhibiting effects of both carbamates and organophosphates.

p. 39, line 5: Delete " a".

p. 40, lines 31  34: This discussion of the degree of inhibition of cholinesterase following the cessation of dosing is confusing. The data show cholinesterase levels were 17% below baseline.

p. 41, line 5: Revise to read ". . . greatly limit the value of this study . . . ." p. 43, table: Correct the name of the first cited study to " Gledhill"; insert closing parenthesis for the Gratz study.

p. 45 line 41: Revise to read " to take into account the fact that . . . ."

p. 46, line 45: Delete "( 3)"

p. 48, lind 37: Revise to read " One subject in the ethephon group was asymptomatic."

p. 51, lines 4  6: The meaning of this sentence is unclear; a word may be missing or added.

p. 51, lines 9 11: Revise to read ". . . a reference dose of 0.06 mg/ kg/ day for assessment of both acute and chronic dietary risk ( 1.8 mg/ kg/ day with an uncertainty factor of 10x for intraspecies variability and a 3x factor for use of a LOAEL  )".

p. 57, line 21: The correct citation is Carley 2006f.

p. 59, line 32: Insert left parenthesis before " Campbell 1984)"

p. 62, lines 21  22: Correct the text to read " and no quality assurance information was provided."

P. 65, line 25: Insert right parenthesis after the word " volunteers."

p. 67, lines 24, 28: Add the first initial " A." to the author's name for Dr. Khasawinah.

p. 68, line 44: The citation is incomplete.

p. 69, line 11: The correct date of the Zendzian article cited in the text is 2000.


[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Page 38748]
[FR Doc No: 2018-16798]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83756; File No. SR-BYX-2012-019]

Self-Regulatory Organization; Cboe BYX Exchange, Inc.; Order
Granting an Extension to Limited Exemption From Rule 612(c) of
Regulation NMS in Connection With the Exchange's Retail Price
Improvement Program

August 1, 2018.
    On November 27, 2012, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule) \1\ that granted the BATS
BYX-Exchange, Inc. (nka ``Cboe BYX'' or the ``Exchange'') a limited
exemption from the Sub-Penny Rule in connection with the operation of
the Exchange's Retail Price Improvement (``RPI'') Program (the
``Program''). The limited exemption was granted concurrently with the
Commission's approval of the Exchange's proposal to adopt the Program
for a one-year pilot term.\2\ The exemption was granted coterminous
with the effectiveness of the pilot Program and has been extended five
times; \3\ both the pilot Program and exemption are scheduled to expire
on July 31, 2018.
---------------------------------------------------------------------------

    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 68303 (November 27,
2012), 77 FR 71652 (December 3, 2012) (``RPI Approval Order'') (SR-
BXY-2012-019).
    \3\ See Securities Exchange Act Release Nos. 71249 (January 7,
2014), 79 FR 2229 (January 13, 2012) (SR-BYX-2014-001) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Extend the Pilot Period for the RPI); 71250 (January 7, 2014), 79 FR
2234 (January 13, 2012) (Order Granting an Extension to Limited
Exemption From Rule 612(c) of Regulation NMS in Connection With the
Exchange's Retail Price Improvement Program); 74111 (January 22,
2015), 80 FR 4598 (January 28, 2015) (SR-BYX-2015-05) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Extend the Pilot Period for the RPI); and 74115 (January 22, 2015),
80 FR 4324 (January 27, 2015) (Order Granting an Extension to
Limited Exemption From Rule 612(c) of Regulation NMS in Connection
With the Exchange's Retail Price Improvement Program); 76965
(January 22, 2016), 81 FR 4682 (January 27, 2016) (SR-BYX-2016-01)
(Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change to Extend the Pilot Period for the RPI); 76953 (January 21,
2016), 81 FR 4728 (January 27, 2016) (Order Granting an Extension to
Limited Exemption From Rule 612(c) of Regulation NMS in Connection
With the Exchange's Retail Price Improvement Program); 78180 (June
28, 2016), 81 FR 43306 (July 1, 2016) (SR-BYX-2016-15) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Extend the Pilot Period for the RPI); 78178 (July 5, 2016), 81 FR
43689 (July 5, 2016) (Order Granting an Extension to Limited
Exemption From Rule 612(c) of Regulation NMS in Connection With the
Exchange's Retail Price Improvement Program); 81368 (August 10,
2017), 82 FR 38960 (August 16, 2017) (SR-BatsBYX-2017-18) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Extend the Pilot Period for the RPI); 81364 (August 8, 2018), 82 FR
38733 (August 15, 2017) (Order Granting an Extension to Limited
Exemption From Rule 612(c) of Regulation NMS in Connection With the
Exchange's Retail Price Improvement Program).
---------------------------------------------------------------------------

    The Exchange now seeks to extend the exemption until December 31,
2018.\4\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the Program
until December 31, 2018.\5\ In its request to extend the exemption, the
Exchange notes that the Program was implemented gradually over time.
Accordingly, the Exchange has asked for additional time to allow itself
and the Commission to analyze data concerning the Program, which the
Exchange committed to provide to the Commission, as well as to allow
additional opportunities for greater participation in the Program.\6\
For this reason and the reasons stated in the Order originally granting
the limited exemption, the Commission finds that extending the
exemption, pursuant to its authority under Rule 612(c) of Regulation
NMS, is appropriate in the public interest and consistent with the
protection of investors.
---------------------------------------------------------------------------

    \4\ See letter from Anders Franzon, Senior Vice President and
Associate General Counsel, Cboe BYX, to Brent J. Fields, Secretary,
Commission, dated July 30, 2018.
    \5\ See SR-CboeBYX-2018-015.
    \6\ See RPI Approval Order, supra note 2, at 77 FR at 71657.
---------------------------------------------------------------------------

    THEREFORE, IT IS HEREBY ORDERED, that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612(c) of Regulation NMS that allows it to accept and rank orders
priced equal to or greater than $1.00 per share in increments of
$0.001, in connection with the operation of its RPI Program.
    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934. Responsibility
for compliance with any applicable provisions of the federal securities
laws must rest with the persons relying on the exemptions that are the
subject of this Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(83).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2018-16798 Filed 8-6-18; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 184 (Monday, September 27, 2021)]
[Rules and Regulations]
[Pages 53217-53218]
[FR Doc No: 2021-20839]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2020-0033]
RIN 1625-AA09

Drawbridge Operation Regulation; Rainy River, Rainy Lake and
Their Tributaries, Rainier, MN

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Final rule.

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SUMMARY: The Coast Guard is altering the regulation for the Canadian
National Railroad Bridge, mile 85.0, across the Rainy River to allow it
to operate remotely. The request was made by the bridge owner. The
bridge will continue to open on signal.

DATES:  This rule is effective October 27, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov. Type USCG-
2020-0033 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Lee D. Soule, Bridge Management Specialist, Ninth
Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
OMB Office of Management and Budget
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On October 16, 2020, we published a notice of temporary deviation
in the Federal Register (85 FR 19658) from regulations; request for
comments. This deviation was effective from midnight on May 1, 2020, to
midnight on October 15, 2020. Due to COVID-19 Staffing, an issue
publishing was delayed; but we utilized local stakeholder and Local
Notice to Mariner outreach to solicit comments. We did not receive any
comments. On July 6, 2021, we published in the Federal Register (86 FR
23880) a notice of proposed rulemaking and we received no comments
during the 60-day comment period.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
Rainy River and Rainy Lake serve as the border between the United
States of America and Canada. This bridge is a single leaf, bascule
type railroad bridge that provides a horizontal clearance of 125 feet.
The water level on Rainy Lake and under the bridge is controlled by a
hydro-electric dam facility at International Falls, Minnesota, thus
charted datum is based on the water level surface of Rainy Lake when
the gauge at Fort Frances, Canada, reads 1107.0 feet resulting in a
variable vertical clearance of 6 to 10 feet in the closed position. The
railroad bridge carries significant train traffic across the
international border. Rainer, Minnesota, is a customs port-of-entry.

IV. Discussion of Comments, Changes and the Final Rule

    As discussed in section II we published two documents in the
Federal Register soliciting comments from the public and did not
receive any comments.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protesters.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, it has
not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the ability that
vessels can still transit the bridge given advanced notice or on signal
depending on the season.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard did not receive any comments from the Small
Business Administration on this rule. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section V.A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series) which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This rule promulgates the operating
regulations or procedures for drawbridges and is categorically excluded
from further review, under paragraph L49, of Chapter 3, Table3-1 of the
U.S. Coast Guard Environmental Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. Revise Sec.  117.664 to read as follows:

Sec.  117.664   Rainy River, Rainy Lake and their tributaries.

    The draw of the Canadian National Railroad Bridge, mile 85.0, at
Rainer, MN may operate remotely, and shall open on signal; except that,
from October 16 to April 30, the draw shall open on signal if at least
12-hours advance notice is provided. The commercial phone number to
provide advance notice shall be posted on the bridge so that it is
plainly visible to vessel operators approaching the up or downstream
side of the bridge. The owners of the bridge shall provide and keep in
good legible condition two board gauges painted white with black
figures to indicate the vertical clearance under the closed draw at all
water levels. The gauges shall be so placed on the bridge that they are
plainly visible to operators of vessels approaching the bridge either
up or downstream. The bridge shall operate and maintain a VHF-FM Marine
Radio.

M.J. Johnston,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2021-20839 Filed 9-24-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 162 (Thursday, August 21, 2014)]
[Rules and Regulations]
[Pages 49449-49452]
[FR Doc No: 2014-19363]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0060; Directorate Identifier 2012-NM-194-AD;
Amendment 39-17943; AD 2014-16-19]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directives (AD) 2006-21-08,
AD 2007-14-01, AD 2008-25-02, AD 2010-04-09, AD 2011-01-02, and AD
2012-16-05, for certain Airbus Model A330 and A340 series airplanes. AD
2006-21-08, AD 2007-14-01, AD 2008-25-02, AD 2010-04-09, AD 2011-01-02,
and AD 2012-16-05 required revising the maintenance program or
inspection program to incorporate certain maintenance requirements and
airworthiness limitations for fuel tank systems. This new AD requires a
new maintenance or inspection program revision. This AD was prompted by
a determination that more restrictive maintenance requirements and
airworthiness limitations are necessary. We are issuing this AD to
prevent the potential of ignition sources inside fuel tanks, which, in
combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

DATES: This AD becomes effective September 25, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of September
25, 2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0060; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80;
email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede the ADs listed below:
     Airworthiness Directive AD 2006-21-08, Amendment 39-14793
(71 FR 61639, October 19, 2006);
     AD 2007-14-01, Amendment 39-15123 (72 FR 38006, July 12,
2007);
     AD 2008-25-02, Amendment 39-15760 (73 FR 75307, December
11, 2008);
     AD 2010-04-09, Amendment 39-16202 (75 FR 7940, February
23, 2010; corrected March 3, 2010 (75 FR 9515));
     AD 2011-01-02, Amendment 39-16555 (76 FR 432, January 5,
2011); and
     AD 2012-16-05, Amendment 39-17152 (77 FR 48425, August 14,
2012).
    Airworthiness Directives AD 2006-21-08, AD 2007-14-01, AD 2008-25-
02, AD 2010-04-09, AD 2011-01-02, and AD 2012-16-05 applied to certain
Airbus Model A330 and A340 series airplanes. The NPRM published in the
Federal Register on February 27, 2014 (79 FR 11019).
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2012-0168, dated August 31, 2012 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition certain Airbus Model A330
and A340 series airplanes. The MCAI states:

    Prompted by an accident [involving a fuel tank system explosion
in flight] * * * the FAA published Special Federal Aviation
Regulation (SFAR) 88 (66 FR 23086, May 7, 2001) and the Joint
Aviation Authorities (JAA) published Interim Policy INT/POL/25/12.
The design review conducted Airbus to develop Fuel Airworthiness
Limitations (FAL) for Airbus on A330 and A340 aeroplanes in response
to these regulations.
    The FAL* * * have been approved by the European Aviation Safety
Agency (EASA)* * *ALS Part 5.
    Failure to comply with items as identified in Airbus A330 and
A340 ALS Part 5 could result in a fuel tank explosion and consequent
loss of the aeroplane.
    To address this condition, EASA issued:

    EASA AD 2007-0023, dated January 25, 2007 [http://ad.easa.europa.eu/ad/2007-0023], which corresponds to FAA AD 2007-
14-01, Amendment 39-15123 (72 FR 38006, July 12, 2007) to require
compliance with FAL* * * (comprising maintenance/inspection tasks
and Critical Design Configuration Control Limitations (CDCCL)) for
A330 aeroplanes, and
    EASA AD 2006-0205, dated July 11, 2006 [http://ad.easa.europa.eu/ad/2006-0205], which also corresponds to FAA AD
2007-14-01, Amendment 39-15123 (72 FR 38006, July 12, 2007) to
require compliance with FAL * * * (comprising maintenance/inspection
tasks and Critical Design Configuration Control Limitations (CDCCL))
for Airbus A340 aeroplanes.
    All other EASA ADs * * * required accomplishment of aeroplane
modifications related to Fuel Tank Safety items, the requirements
and compliance times of which are now integrated into ALS Part 5.
    For the reasons described above this [EASA] AD * * * requires
the implementation of the new or more restrictive maintenance
requirements and/or airworthiness limitations as specified in the
revision 00 of Airbus A340 ALS Part 5.

The unsafe condition is the potential of ignition sources inside fuel
tanks. Such ignition sources, in combination with flammable fuel
vapors, could result in fuel tank explosions and consequent loss of the
airplane. You may examine the MCAI in the AD docket on the Internet at
http://www.regulations.gov/#!documentDetail;D=FAA-2014-0060-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 11019, February 27,
2014) or on the determination of the cost to the public.

Explanation of Change Made to This AD

    We have revised paragraph (i) of this AD by removing a reference to
a paragraph that was not needed.

``Contacting the Manufacturer'' Paragraph in This AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    We have become aware that some operators have misunderstood or
misinterpreted the Airworthy Product paragraph to allow the owner/
operator to use messages provided by the manufacturer as approval of
deviations during the accomplishment of an AD-mandated action. The
Airworthy Product paragraph does not approve messages or other
information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed the paragraph and retitled
it ``Contacting the Manufacturer.'' This paragraph now clarifies that
for any requirement in this AD to obtain corrective actions from a
manufacturer, the actions must be accomplished using a method approved
by the FAA, the European Aviation Safety Agency (EASA), or Airbus's
EASA Design Organization Approval (DOA).
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    We also have decided not to include a generic reference to either
the ``delegated agent'' or ``design approval holder (DAH) with State of
Design Authority design organization approval,'' but instead we have
provided the specific delegation approval granted by the State of
Design Authority for the DAH throughout this AD.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD with the changes described
previously and minor editorial changes. We have determined that these
minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 11019, February 27, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 11019, February 27, 2014).
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Costs of Compliance

    We estimate that this AD affects 80 airplanes of U.S. registry.
    We also estimate that it will take about 1 work-hour per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost $0 per product.
Based on these figures, we estimate the cost of this AD on U.S.
operators to be $6,800, or $85 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0060; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

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:
0
a. Removing Airworthiness Directives (AD) AD 2006-21-08, Amendment 39-
14793 (71 FR 61639, October 19, 2006); AD 2007-14-01, Amendment 39-
15123 (72 FR 38006, July 12, 2007); AD 2008-25-02, Amendment 39-15760
(73 FR 75307, December 11, 2008); AD 2010-04-09, Amendment 39-16202 (75
FR 7940, February 23, 2010; corrected March 3, 2010 (75 FR 9515)); AD
2011-01-02, Amendment 39-16555 (76 FR 432, January 5, 2011); AD 2012-
16-05, and Amendment 39-17152 (77 FR 48425, August 14, 2012); and
0
b. Adding the following new AD:

2014-16-19 Airbus: Amendment 39-17943. Docket No. FAA-2014-0060;
Directorate Identifier 2012-NM-194-AD.

(a) Effective Date

    This AD becomes effective September 25, 2014.

(b) Affected ADs

    This AD replaces the ADs specified in paragraphs (b)(1) through
(b)(6) of this AD.
    (1) AD 2006-21-08, Amendment 39-14793 (71 FR 61639, October 19,
2006).
    (2) AD 2007-14-01, Amendment 39-15123 (72 FR 38006, July 12,
2007).
    (3) AD 2008-25-02, Amendment 39-15760 (73 FR 75307, December 11,
2008).
    (4) AD 2010-04-09, Amendment 39-16202 (75 FR 7940, February 23,
2010; corrected March 3, 2010 (75 FR 9515)).
    (5) AD 2011-01-02, Amendment 39-16555 (76 FR 432, January 5,
2011).
    (6) AD 2012-16-05, Amendment 39-17152 (77 FR 48425, August 14,
2012).

(c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
243, -223F, -243F, -301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes, certificated in any category, all manufacturer
serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance requirements and airworthiness limitations are
necessary. We are issuing this AD to prevent the potential of
ignition sources inside fuel tanks, which, in combination with
flammable fuel vapors, could result in fuel tank explosions and
consequent loss of the airplane.

(f) Compliance

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

(g) Maintenance Program Revision and Airworthiness Limitations
Compliance

    (1) Within 3 months after the effective date of this AD, revise
the maintenance or inspection program, as applicable, by
incorporating Airbus A330 Airworthiness Limitations Section (ALS)
Part 5--Fuel Airworthiness Limitations, dated November 16, 2011.
    (2) Comply with all applicable instructions and airworthiness
limitations included in Airbus A330 ALS Part 5--Fuel Airworthiness
Limitations, dated November 16, 2011. The initial compliance times
for the actions specified in Airbus A330 ALS Part 5--Fuel
Airworthiness Limitations, dated November 16, 2011, are at the later
of the times specified in paragraphs (g)(2)(i) and (g)(2)(ii) of
this AD, except as required by paragraphs (h) and (i) of this AD.
    (i) Within the applicable compliance times specified in Airbus
A330 ALS Part 5--Fuel Airworthiness Limitations, dated November 16,
2011.
    (ii) Within 3 months after accomplishing the actions required by
paragraph (g)(1) of this AD.

(h) Exceptions to Compliance Times for Design Changes

    (1) For type design changes specified in ``Sub-part 5-2 Changes
to Type Design,'' of Airbus A330 ALS Part 5--Fuel Airworthiness
Limitations, dated November 16, 2011, the compliance times are
defined as ``Embodiment Limits,'' except as defined in paragraph
(h)(2) of this AD.
    (2) Where Airbus A330 ALS Part 5--Fuel Airworthiness
Limitations, dated November 16, 2011, specifies a compliance time
based on a calendar date for modifying the control circuit for the
fuel pump of the center fuel tank (installing ground fault
interrupters to the center tank fuel pump control circuit), the
compliance date is September 18, 2016 (48 months after the effective
date of AD 2012-16-05, Amendment 39-17152 (77 FR 48425, August 14,
2012)).

(i) No Alternative Actions, Intervals, or Critical Design Configuration
Control Limitations (CDCCLs)

    After accomplishing the revision required by paragraph (g) of
this AD, no alternative actions (e.g., inspections), intervals, or
CDCCLs may be used; except as specified in paragraph (h) of this AD;
or unless the actions, intervals, or CDCCLs are approved as an
alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
European

Aviation Safety Agency Airworthiness Directive 2012-0168, dated
August 31, 2012; for related information. You may examine the MCAI
in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0060-0002.

(l) 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 this AD specifies otherwise.
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 5--
Fuel Airworthiness Limitations, dated November 16, 2011. The cover
page of this document is undated and identified as Revision 00.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 4, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-19363 Filed 8-20-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14207-14208]
[FR Doc No: 2020-04990]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0001]

Scientific and Ethical Considerations for the Inclusion of
Pregnant Women in Clinical Trials

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Scientific and
Ethical Considerations for the Inclusion of Pregnant Women in Clinical
Trials.'' The meeting will be convened by Duke University's Robert J.
Margolis, Center for Health Policy (Duke-Margolis) and supported by a
cooperative agreement with FDA. The meeting is intended to gather
industry, patient, clinician,

researcher, institutional review board, ethicist, professional society
and other stakeholder input on the scientific and ethical issues that
surround the inclusion of pregnant women in clinical trials for drug
development.

DATES: The public meeting will be held on April 16, 2020, from 9 a.m.
to 5 p.m. See the SUPPLEMENTARY INFORMATION section for registration
information.

ADDRESSES: The public meeting will be held at the National Press Club
Main Ballroom, 529 14th St. NW, Washington, DC 20045.

FOR FURTHER INFORMATION CONTACT: Jasmine Smith, Office of New Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or Catherine
Sewell, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver
Spring, MD 20993-0002, Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA endorses an informed and balanced approach to gathering data
informing the safe and effective use of drugs and biological products
in pregnancy through judicious inclusion of pregnant women in clinical
trials and careful attention to potential fetal risk. Input from this
meeting will help provide such information on the development of
therapies for pregnancy-specific conditions and for general medical
conditions that occur in women of childbearing age and require
treatment during pregnancy. This meeting supports the objectives of The
Task Force on Research Specific to Pregnant Women and Lactating Women
(``Task Force'' or ``PRGLAC'') which was established by section 2041 of
the 21st Century Cures Act, Public Law 114-255, to provide advice and
guidance on activities related to identifying and addressing gaps in
knowledge and research on safe and effective therapies for pregnant
women and lactating women, including the development of such therapies
and the collaboration on and coordination of such activities.\1\ Input
from this meeting may also help further inform FDA's work toward the
finalization of the Agency's draft guidance: Pregnant Women: Scientific
and Ethical Considerations for Inclusion in Clinical Trials (83 FR
15161, April 6, 2018).
---------------------------------------------------------------------------

    \1.\ https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf.
---------------------------------------------------------------------------

II. Topics for Discussion at the Public Meeting

    The meeting will allow participants (including industry,
clinicians, patients, researchers, institutional review boards,
ethicists, professional societies and other stakeholders) to provide
input on key topics, including:
     Key areas of unmet needs for therapeutic development or
clinical data in obstetrics
     The regulatory, scientific, and ethical considerations and
challenges in the enrollment of pregnant women in clinical research
    For more information on the meeting topics and discussion
questions, visit https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. FDA
will publish a discussion guide outlining background information on the
topic areas to this website approximately 2 weeks before the meeting
date. FDA will also post the agenda and other meeting materials to this
website approximately 5 business days before the meeting.
    The format of the public meeting will consist of a series of
presentations, panel discussions, and open discussion.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. Registrants will receive confirmation once they
have been accepted. If time and space permit, onsite registration on
the day of the public meeting will be provided beginning at 8 a.m. We
will let registrants know if registration closes before the day of the
public meeting.
    If you need special accommodations due to a disability, please
contact Jasmine Smith, Office of New Drugs, Center for Drug Evaluation
and Research, Food and Drug Administration, at
<EMAIL_ADDRESS>or<PHONE_NUMBER>; or Catherine Sewell,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver Spring, MD 20993-
0002, Fax:<PHONE_NUMBER>.
    Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Meeting: This public meeting will
also be webcast and archived video footage will be available at the
event website. If you are unable to attend the meeting in person, you
can register to view a live webcast of the meeting. Persons interested
in viewing the live webcast are encouraged to register in advance. You
will be asked to indicate in your registration if you plan to attend in
person or via the webcast. Please register for the webcast by visiting
https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials.
    Registered webcast participants will be sent technical system
requirements in advance of the event. It is recommended that you review
these technical system requirements prior to joining the streaming
webcast of the public meeting.
    FDA has verified the website addresses in this document as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Transcripts: Please be advised that transcripts of the public
meeting will not be available.

    Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04990 Filed 3-10-20; 8:45 am]
 BILLING CODE 4164-01-P