[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Rules and Regulations]
[Page 25986-25990]
[DOCID:fr08my08-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28384; Directorate Identifier 2006-NM-165-AD;
Amendment 39-15516; AD 2008-10-10]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-600, -700, -700C, -
800, and -900 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes.
This AD requires revising the Airworthiness Limitations (AWLs) section
of the Instructions for Continued Airworthiness by incorporating new
limitations for fuel tank systems to satisfy Special Federal Aviation
Regulation No. 88 requirements. This AD also requires the initial
inspection of a certain repetitive AWL inspection to phase in that
inspection, and repair if necessary. This AD results from a design
review of the fuel tank systems. We are issuing this AD to prevent the
potential for ignition sources inside fuel tanks caused by latent
failures, alterations, repairs, or maintenance actions, which, in
combination with flammable fuel vapors, could result in a fuel tank
explosion and consequent loss of the airplane.

DATES: This AD is effective June 12, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 12,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document 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 20590.

FOR FURTHER INFORMATION CONTACT: Samuel Spitzer, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6510; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-600, -700, -700C, -800, and -900 series
airplanes. That NPRM was published in the Federal Register on July 6,
2007 (72 FR 36920). That NPRM proposed to require revising the
Airworthiness Limitations (AWLs) section of the Instructions for
Continued Airworthiness (ICA) by incorporating new limitations for fuel
tank systems to satisfy Special Federal Aviation Regulation No. 88
requirements. That NPRM also proposed to require the initial inspection
of a certain repetitive AWL inspection to phase in that inspection, and
repair if necessary.

Actions Since NPRM Was Issued

    Since we issued the NPRM, Boeing has issued Temporary Revision (TR)
09-020, dated March 2008. Boeing TR 09-020 is published as Section 9 of
the Boeing 737-600/700/800/900 Maintenance Planning Data (MPD)
Document, D626A001-CMR, Revision March 2008 (hereafter referred to as
``Revision March 2008 of the MPD''). The NPRM referred to Revision
March 2006 of the MPD as the appropriate source of service information
for accomplishing the proposed actions. Revision March 2008 of the MPD,
among other actions, includes the following changes:
     Removes the repetitive task interval of 36,000 flight
cycles from AWLs No. 28-AWL-01 and No. 28-AWL-03.
     Revises the task description for AWL No. 28-AWL-01 to
harmonize it with AWL No. 28-AWL-02 by removing references to certain
station numbers.
     Revises AWL No. 28-AWL-03 to reflect the new maximum loop
resistance values associated with the lightning protection of the
unpressurized fuel quantity indicating system (FQIS) wire bundle
installations.
    Accordingly, we have revised paragraphs (f), (g), and (h) of this
AD to refer to Revision March 2008 of the MPD. We also have added a new
paragraph (j) to this AD specifying that actions done before the
effective date of this AD in accordance with Revisions March 2006
through February 2008 of the MPD are acceptable for compliance with the
corresponding requirements of paragraphs (g) and (h) of this AD. (In
Revision March 2007 of the MPD, Boeing revised the document title to
``737-600/700/800/900.'')
    We also have removed reference to 36,000 total flight cycles from
paragraph (h)(1) of this AD and revised the initial threshold for
accomplishing AWL No. 28-AWL-03 to within 120 months since the date of
issuance of the original standard airworthiness certificate or the date
of issuance of the original export certificate of airworthiness.
    Since publication of Revision March 2006 of the MPD, Boeing has
revised the contents of certain subsections of the MPD. Information
pertaining to the fuel system AWLs has been removed from Subsection D,
``AIRWORTHINESS

LIMITATIONS--SYSTEMS'' and placed into a new Subsection E,
``AIRWORTHINESS LIMITATIONS--FUEL SYSTEMS.'' The subsequent subsections
of the MPD were reidentified accordingly. Therefore, we have revised
paragraphs (g)(1), (g)(2), and (g)(3) of this AD to refer to
Subsections E, F, and G, respectively.
    Operators should note that we have revised paragraph (g) of this AD
to require incorporating only AWLs No. 28-AWL-01 through No. 28-AWL-22
inclusive. AWL No. 28-AWL-23 was added in Revision May 2006 of the MPD,
and AWL No. 28-AWL-24 was added in Revision October 2006 of the MPD.
However, as an optional action, operators may incorporate those two
AWLs as specified in paragraph (g) of this AD.
    Operators should also note that we have issued a separate NPRM
(Docket No. FAA-2007-28661) that, in part, proposes to incorporate AWLs
No. 28-AWL-19 and No. 28-AWL-23 into the AWLs section of the ICA. That
NPRM was published in the Federal Register on July 10, 2007 (72 FR
37479).
    We have also issued AD 2008-06-03, amendment 39-15415 (73 FR 13081,
March 12, 2008) that, in part, requires revising the AWLs section of
the ICA to incorporate AWLs No. 28-AWL-21, No. 28-AWL-22, and No. 28-
AWL-24. Therefore, we have added a new paragraph (k) to this AD
specifying that incorporating AWLs No. 28-AWL-21, No. 28-AWL-22, and
No. 28-AWL-24 in accordance with paragraph (g) of this AD terminates
the action required by paragraph (h)(1) of AD 2008-06-03.

Other Changes Made to This AD

    For standardization purposes, we have revised this AD in the
following ways:
     We have added a new paragraph (i) to this AD to specify
that no alternative inspections, inspection intervals, or critical
design configuration control limitations (CDCCLs) may be used unless
they are part of a later approved revision of Revision March 2008 of
the MPD, or unless they are approved as an alternative method of
compliance (AMOC). Inclusion of this paragraph in the AD is intended to
ensure that the AD-mandated airworthiness limitations changes are
treated the same as the airworthiness limitations issued with the
original type certificate.
     We have revised Note 2 of this AD to clarify that an
operator must request approval for an AMOC if the operator cannot
accomplish the required inspections because an airplane has been
previously modified, altered, or repaired in the areas addressed by the
required inspections.
     We have revised paragraph (h) of this AD to specify that
accomplishing AWL No. 28-AWL-03 as part of an FAA-approved maintenance
program before the applicable compliance time constitutes compliance
with the applicable requirements of that paragraph.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the six commenters.

Request To Revise the Loop Resistance Values for AWL No. 28-AWL-03

    Boeing and KLM Royal Dutch Airlines (KLM) state that the loop
resistance values for AWL No. 28-AWL-03 specified in Revision March
2006 of the MPD are going to be revised, since those values are
relevant for production airplanes. The commenters also state that the
revised values will be more representative of the expected values for
in-service airplanes. Boeing points out that, according to paragraph
(h) of the NPRM, the revised values should be able to be used in
accordance with a later revision of the MPD if the revision is approved
by the Seattle Aircraft Certification Office (ACO), FAA.
    We agree that operators may use the revised loop resistance values
for AWL No. 28-AWL-03 in accordance with Revision March 2008 of the
MPD. As stated previously, we have revised this AD accordingly.

Request To Extend the Task Intervals for Certain AWL Inspections

    KLM, on behalf of several operators, requests that we review a 45-
page proposal to align certain airworthiness limitation item (ALI)
intervals with the applicable maintenance significant item (MSI) and
enhanced zonal analysis procedure (EZAP) intervals for Model 737, 747,
757, 767, and 777 airplanes. The recommendations in that proposal
ensure that the ALI intervals align with the maintenance schedules of
the operators. Among other changes, the proposal recommends extending
certain AWL inspection intervals from 10 years/36,000 flight cycles to
12 years for Model 737-600, -700, -700C, -800, and -900 series
airplanes.
    The Air Transport Association (ATA), on behalf of its member Delta
Airlines (DAL), notes an inconsistency between the inspection interval
specified in Revision March 2006 of the MPD and the compliance
threshold specified in paragraph (h)(1) of the NPRM. Paragraph (h)(1)
of the NPRM specifies accomplishing the initial inspection prior to the
accumulation of 36,000 total flight hours, or 120 months since the date
of issuance of the original standard airworthiness certificate or the
date of issuance of the original export certificate of airworthiness,
whichever occurs first. DAL requests that we revise the compliance
threshold to 36,000 ``total flight cycles.''
    We disagree with KLM's request to extend certain AWL inspection
intervals to 12 years. However, as stated previously, we have deleted
the 36,000-total-flight-hour parameter from paragraph (h)(1) of this AD
to correspond with the task interval for AWL No. 28-AWL-03 as specified
in Revision March 2008 of the MPD. In developing an appropriate
compliance time for this action, we considered the urgency associated
with the subject unsafe condition and the practical aspect of
accomplishing the required actions within a period of time that
corresponds to the normal scheduled maintenance for most affected
operators. However, according to the provisions of paragraph (l) of
this AD, we might approve requests to adjust the compliance time if the
request includes data that prove that the new compliance time would
provide an acceptable level of safety.

Request To Require the Incorporation of AWL No. 28-AWL-24

    The ATA, on behalf of its member Delta Airlines (DAL), notes that
AD 2008-06-03 requires a revision to the AWLs section of the
Instructions for Continued Airworthiness to incorporate AWLs No. 28-
AWL-21, No. 28-AWL-22, and No. 28-AWL-24. DAL states that AD 2008-06-03
appears to duplicate the proposed requirements of the NPRM, and that it
is more appropriate to have this AD require the incorporation of AWLs
No. 28-AWL-21, No. 28-AWL-22, and No. 28-AWL-24.
    We infer that the commenters request that we delete paragraph
(h)(1) from AD 2008-06-03, and revise this AD to require incorporating
AWL No. 28-AWL-24 into the AWLs section of the Instructions for
Continued Airworthiness. (This AD requires the incorporation of AWLs
No. 28-AWL-01 through No 28-AWL-22 and specifies that AWL No. 28-AWL-24
may be incorporated as an optional action.) We do not agree to revise
this AD or AD 2008-06-03. Revision March 2008 of the MPD contains an
applicability column that identifies the airplane configuration to
which the AWL applies. That AWL is required only for airplanes that
have that configuration. If

the applicability column identifies a service bulletin, then the
operator would not need to adhere to the AWL until the airplane is
modified in accordance with that service bulletin. There is no penalty
for incorporating the AWL before accomplishing the actions specified in
the service bulletin, and doing so actually reduces the paperwork
burden for the FAA and the operators by incorporating subsections E, F,
and G in their entirety.
    Also, it is necessary to have AD 2008-06-03 require the
incorporation of AWLs No 28-AWL-21, No. 28-AWL-22, and No. 28-AWL-24,
since those AWLs are tied to the design change required by paragraph
(g) of AD 2008-06-03. If an operator were to comply with AD 2008-06-03
before complying with this AD and did not revise its MPD concurrently
with accomplishing the design change, then the operations checks
required by those AWLs would not be performed at the proper time.
    However, we do not intend for operators to incorporate AWLs No. 28-
AWL-21 and No. 28-AWL-22 into the AWLs section of the Instructions for
Continued Airworthiness twice by two separate airworthiness directives.
As stated previously, we have added a new paragraph (k) to this AD
specifying that incorporating AWLs No. 28-AWL-21, No. 28-AWL-22, and
No. 28-AWL-24 in accordance with paragraph (g) of this AD terminates
the action required by paragraph (h)(1) of AD 2008-06-03.

Request To Issue Separate Airworthiness Directives

    The ATA, on behalf of its member American Airlines (AAL), requests
that we delete the initial inspection and repair specified in paragraph
(h) of the NPRM and address those actions with a separate airworthiness
directive. AAL states that the different actions and compliance times
proposed in paragraphs (g) and (h) of the NPRM create confusion and
difficulty in tracking compliance. AAL also states that it will not be
able to say it is fully compliant with the requirements of the NPRM by
December 16, 2008, because it will still be in the process of
completing the initial inspection and repair specified in paragraph (h)
of the NPRM.
    AirTran Airways states that it is unclear as to why AWL No. 28-AWL-
03 is given special consideration in paragraph (h) of the NPRM. AirTran
Airways also states that, although it is not affected by the compliance
time specified in paragraph (h)(2) of the NPRM, it assumes that there
are other operators who will be affected by it due to the age of the
fleet. AirTran Airways, therefore, requests that we substantiate why
the NPRM contains a more restrictive requirement for AWL No. 28-AWL-03.
    We disagree with issuing a separate airworthiness directive to
address the requirements of the paragraph (h) of this AD. Some
airplanes might have already passed the age when the initial inspection
required by AWL No. 28-AWL-03 should have been accomplished. The intent
of paragraph (h) of this AD is to phase in that inspection for those
airplanes. Further, paragraph (h)(2) of this AD provides a 24-month
grace period for an airplane that has already exceeded the compliance
threshold specified in paragraph (h)(1) of this AD. No change to this
AD is necessary in this regard.

Request To Revise Appendix 1

    Boeing requests that we revise Appendix 1 of the NPRM to add an
additional ATA section for AWL No. 28-AWL-02 and for AWL No. 28-AWL-17.
The ATA, on behalf of its member DAL, requests that we revise Appendix
1 of the NPRM as follows: (1) add the task title for AWLs No. 28-AWL-
08, No. 28-AWL-12, No. 28-AWL-13, and No. 28-AWL-22 based on the
information found in the MPD, (2) add the ``ALI/CDCCL'' designation,
airplane maintenance manual (AMM) reference, and task title for AWL No.
28-AWL-20 based on the information in the MPD, and (3) delete any
duplicate sources of service information and reference a single source
document that provides the task instructions necessary to comply with
the AWLs.
    We disagree with revising the AMM references, since we have deleted
Appendix 1 from this AD. The purpose of Appendix 1 was to assist
operators in identifying the AMM tasks that could affect compliance
with a CDCCL. However, we have also received several similar comments
regarding the appendices in other NPRMs that address the same unsafe
condition on other Boeing airplanes. Those comments indicate that
including non-required information in those NPRMs has caused confusion.
Further, Revision March 2008 of the MPD contains most of the updated
information that is listed in Appendix 1 of the NPRM. Therefore, we
have removed Appendix 1 from this AD.

Request To Revise Note 2

    Boeing requests that we revise Note 2 of the NPRM to clarify the
need for an AMOC. Boeing states that the current wording is difficult
to follow, and that the note is meant to inform operators that an AMOC
to the required MPD AWLs might be required if an operator has
previously modified, altered, or repaired the areas addressed by the
limitations. Boeing requests that we revise Note 2 as follows:
     Add the words ``according to paragraph (g)'' at the end of
the first sentence.
     Replace the words ``revision to'' with ``deviation from''
in the last sentence.
     Delete the words ``(g) or'' and ``as applicable'' from the
last sentence.
    As stated previously, we have clarified the language in Note 2 of
this AD for standardization with other similar ADs. The language the
commenter requests that we change does not appear in the revised note.
Therefore, no additional change to this AD is necessary in this regard.

Request To Extend the Grace Period for AWL No. 28-AWL-03

    KLM expects to have problems accomplishing the initial inspection
of AWL No. 28-AWL-03 within the 24-month grace period. The commenter
states that if it does the check and does not reach the specified
values, then tank entry outside of heavy maintenance would be
necessary. The commenter also states that it would be helpful to plan
to do this inspection during an overhaul.
    We infer that KLM requests that we extend the grace period for AWL
No. 28-AWL-03 in paragraph (h)(2) of this AD to allow accomplishing the
initial inspection during a regularly scheduled ``D'' check (about 6
years). We disagree with extending the grace period to 6 years. In
developing an appropriate compliance time for this action, we
considered the safety implications, the rate of lightning strikes in
the fleet, and the average age of the fleet. In consideration of these
items, we have determined that an initial compliance time of 120 months
(as discussed previously) with a grace period of 24 months will ensure
an acceptable level of safety. We have not changed the grace period for
AWL No. 28-AWL-03 in this regard.

Request To Revise the Estimated Costs Table

    The ATA, on behalf of its member DAL, states that it disagrees with
the cost estimate for accomplishing the inspection provided in the
``Estimated Costs'' table of the NPRM because it does not include the
time required for accomplishing the additional repetitive inspections.
DAL also states that it will take much more than eight hours to
accomplish the initial inspection.
    We infer the commenters request that we revise the ``Estimated
Cost'' table in this AD to reflect the cost of

accomplishing the repetitive inspections. We do not agree because the
repetitive inspections are not directly required by this AD. This AD
only requires the change to the maintenance program via a revision to
the MPD, and the initial accomplishment of AWL No. 28-AWL-03. Section
91.403(c) of the Federal Aviation Regulations (14 CFR part 91.403(c))
requires the repetitive inspections once the maintenance program is
changed. Although DAL states the initial inspection takes more than 8
hours, it has not provided an estimate. Therefore, we have not changed
this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    There are about 1,960 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs, at
an average labor rate of $80 per work hour, for U.S. operators to
comply with this AD.

                                                 Estimated Costs
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                                                                                Number of
                                                                     Cost per          U.S.-
            Action               Work hours          Parts           airplane       registered      Fleet cost
                                                                                airplanes
----------------------------------------------------------------------------------------------------------------
AWLs revision................               8  None.............            $640             682        $436,480
Inspection...................               8  None.............             640             682         436,480
----------------------------------------------------------------------------------------------------------------

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

    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 DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-10-10 Boeing: Amendment 39-15516. Docket No. FAA-2007-28384;
Directorate Identifier 2006-NM-165-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective June 12,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-600, -700, -700C, -800,
and -900 series airplanes, certificated in any category, with an
original standard airworthiness certificate or original export
certificate of airworthiness issued before March 31, 2006.

    Note 1: Airplanes with an original standard airworthiness
certificate or original export certificate of airworthiness issued
on or after March 31, 2006, must already be in compliance with the
airworthiness limitations specified in this AD because those
limitations were applicable as part of the airworthiness
certification of those airplanes.

    Note 2: This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance (AMOC)
according to paragraph (l) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Unsafe Condition

    (d) This AD results from a design review of the fuel tank
systems. We are issuing this AD to prevent the potential for
ignition sources inside fuel tanks caused by latent failures,
alterations, repairs, or maintenance actions, which, in combination
with flammable fuel vapors, could result in a fuel tank explosion
and consequent loss of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Service Information Reference

    (f) The term ``Revision March 2008 of the MPD,'' as used in this
AD, means Boeing Temporary Revision (TR) 09-020, dated March 2008.
Boeing TR 09-020 is published as Section 9 of the Boeing 737-600/
700/800/900 Maintenance Planning Data (MPD) Document, D626A001-CMR,
Revision March 2008.

Revision to Airworthiness Limitations (AWLs) Section

    (g) Before December 16, 2008, revise the AWLs section of the
Instructions for Continued Airworthiness (ICA) by incorporating into
the MPD the information in the subsections specified in paragraphs
(g)(1), (g)(2), and (g)(3) of this AD; except that the initial
inspection required by paragraph (h) of this AD must be done at the
applicable compliance time specified in that paragraph.
Accomplishing the revision in accordance with a later revision of
the MPD is an acceptable method of compliance if the revision is
approved by the Manager, Seattle Aircraft Certification Office
(ACO), FAA.
    (1) Subsection E, ``AIRWORTHINESS LIMITATIONS--FUEL SYSTEMS,''
of Revision March 2008 of the MPD.
    (2) Subsection F, ``PAGE FORMAT: FUEL SYSTEM AIRWORTHINESS
LIMITATIONS,'' of Revision March 2008 of the MPD.
    (3) Subsection G, ``AIRWORTHINESS LIMITATIONS--FUEL SYSTEM
AWLs,'' AWLs No. 28-AWL-01 through No. 28-AWL-22 inclusive, of
Revision March 2008 of the MPD. As an optional action, AWLs No. 28-
AWL-23 and No. 28-AWL-24, as identified in Subsection G of Revision
March 2008 of the MPD, also may be incorporated into the AWLs
section of the ICA.

Initial Inspection and Repair if Necessary

    (h) At the later of the compliance times specified in paragraphs
(h)(1) and (h)(2) of this AD, do a special detailed inspection of
the lightning shield to ground termination on the out-of-tank fuel
quantity indication system (FQIS) wiring to verify functional
integrity, in accordance with AWL No. 28-AWL-03 of Subsection G of
Revision March 2008 of the MPD. If any discrepancy is found during
the inspection, repair the discrepancy before further flight in
accordance with AWL No. 28-AWL-03 of Subsection G of Revision March
2008 of the MPD. Accomplishing the actions required by this
paragraph in accordance with a later revision of the MPD is an
acceptable method of compliance if the revision is approved by the
Manager, Seattle ACO. Accomplishing AWL No. 28-AWL-03 as part of an
FAA-approved maintenance program before the applicable compliance
time specified in paragraph (h)(1) or (h)(2) of this AD constitutes
compliance with the requirements of this paragraph.

    Note 3: For the purposes of this AD, a special detailed
inspection is: ``An intensive examination of a specific item,
installation, or assembly to detect damage, failure, or
irregularity. The examination is likely to make extensive use of
specialized inspection techniques and/or equipment. Intricate
cleaning and substantial access or disassembly procedure may be
required.''

    (1) Within 120 months since the date of issuance of the original
standard airworthiness certification or the date of issuance of the
original export certificate of airworthiness.
    (2) Within 24 months after the effective date of this AD.

No Alternative Inspections, Inspection Intervals, or Critical Design
Configuration Control Limitations (CDCCLs)

    (i) After accomplishing the actions specified in paragraphs (g)
and (h) of this AD, no alternative inspections, inspection
intervals, or CDCCLs may be used unless the inspections, intervals,
or CDCCLs are part of a later revision of Revision March 2008 of the
MPD that is approved by the Manager, Seattle ACO; or unless the
inspections, intervals, or CDCCLs are approved as an AMOC in
accordance with the procedures specified in paragraph (l) of this
AD.

Credit for Actions Done According to Previous Revisions of the MPD

    (j) Actions done before the effective date of this AD in
accordance with the following MPDs are acceptable for compliance
with the corresponding requirements of paragraphs (g) and (h) of
this AD: Section 9 of the Boeing 737-600/700/700C/700IGW/800/900 MPD
Document, D626A001-CMR, Revision March 2006; Revision May 2006;
Revision October 2006; Revision November 2006; or Revision November
2006 R1; and Section 9 of the Boeing 737-600/700/800/900 MPD
Document, D626A001-CMR, Revision March 2007; Revision March 2007 R1;
Revision March 2007 R2; or Revision February 2008.

Terminating Action for AD 2008-06-03, Amendment 39-15415

    (k) Incorporating AWLs No. 28-AWL-21, No. 28-AWL-22, and No. 28-
AWL-24 into the AWLs section of the ICA in accordance with paragraph
(g) of this AD terminates the action required by paragraph (h)(1) of
AD 2008-06-03.

Alternative Methods of Compliance (AMOCs)

    (l)(1) The Manager, Seattle ACO, has the authority to approve
AMOCs for this AD, if requested in accordance with the procedures
found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (m) You must use Boeing Temporary Revision 09-020, dated March
2008, to the Boeing 737-600/700/800/900 Maintenance Planning Data
(MPD) Document, D626A001-CMR, to do the actions required by this AD,
unless the AD specifies otherwise. Boeing Temporary Revision 09-020
is published as Section 9 of the Boeing 737-600/700/800/900
Maintenance Planning Data (MPD) Document, D626A001-CMR, Revision
March 2008.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue SW., Renton, Washington; or 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/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 29, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-9919 Filed 5-7-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Notices]
[Page 13333-13334]
[DOCID:fr19mr10-127]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for special permits

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before April 19, 2010.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue, Southeast, Washington, DC or at http://
regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on March 11, 2010.
Delmer F. Billings,
Director, Office of Hazardous Materials, Special Permits and Approvals.

                                               New Special Permits
----------------------------------------------------------------------------------------------------------------
                                                                      Regulation(s)         Nature of special
   Application No.          Docket No.             Applicant             affected            permits thereof
----------------------------------------------------------------------------------------------------------------
14977-N.............  ......................  Air Products and     49 CFR 173.301(f)..  To authorize the
                                               Chemicals, Inc.                           transportation in
                                               Allentown, PA.                            commerce of certain DOT
                                                                                Specification 3T
                                                                                cylinders containing
                                                                                Silane without pressure
                                                                                relief devices by motor
                                                                                vehicle and cargo
                                                                                vessel. (modes 1, 3).
14978-N.............  ......................  Air Products and     49 CFR 173.181.....  To authorize the
                                               Chemicals, Inc.                           transportation in
                                               Allentown, PA.                            commerce of pyrophoric
                                                                                liquids in inner metal
                                                                                containers (bubblers)
                                                                                with openings greater
                                                                                than 25mm (1 inch)
                                                                                which are engineered to
                                                                                specific electronics
                                                                                applications that
                                                                                require a larger
                                                                                opening. (modes 1, 3).
149979-N............  ......................  M & N Aviation,      49 CFR 172.101       To authorize the air
                                               Carolina Inc.        Column (9B).         transportation in
                                                                                commerce of certain
                                                                                explosives which are
                                                                                forbidden or exceed
                                                                                quantity limits for
                                                                                shipment by cargo-only
                                                                                aircraft. (mode 4).
14980-N.............  ......................  Fisk Tank Carrier,   49 CFR 173.315       To authorize the one-way
                                               Inc. Columbus, WI.   (j)(4).              transportation in
                                                                                commerce of certain non-
                                                                                DOT specification
                                                                                storage tanks
                                                                                containing propane.
                                                                                (mode 1).
14981-N.............  ......................  Eclipse Aerospace,   49 CFR 173.309(b)..  To authorize the
                                               Inc. (EAI)                                manufacture, marking,
                                               Albuquerque, NM.                          sale and use of non-DOT
                                                                                specification cylinders
                                                                                for use as fire
                                                                                extinguishers. (modes
                                                                                1, 2, 3, 4, 5).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-5898 Filed 3-18-10; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register: November 9, 2005 (Volume 70, Number 216)]
[Rules and Regulations]
[Page 67910-67915]
[DOCID:fr09no05-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2005-0254; FRL-7740-8]

Flucarbazone-sodium; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-
methyl-5-oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole
1-carboxamide, sodium salt and its N-desmethyl metabolite in or on
wheat, forage at 0.30 parts per million (ppm); wheat, grain at 0.01
ppm; wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined
residues of flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Arysta
LifeScience North America Corporation requested this tolerance under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA). The tolerance will expire
on November 30, 2006.

DATES: This regulation is effective November 9, 2005. Objections and
requests for hearings must be received on or before January 9, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in

Unit VI. of the SUPPLEMENTARY INFORMATION. EPA has established a docket
for this action under Docket identification (ID) number OPP-2005-0254.
All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket.
 Although listed in the index, some information is

not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in http://docket.epa.gov/edkpub/index.jsp.
 If you have any questions regarding

the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttp://www.epa.gpo/opptsfrs/home/guidelin.htm/
.

II. Background and Statutory Findings

    In the Federal Register of September 29, 2000 (65 FR 58364) (FRL-
6745-9), EPA issued a time-limited tolerance for combined residues of
the herbicide, flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-
oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-
carboxamide, sodium salt and its N-desmethyl metabolite in or on wheat,
forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm;
and wheat, straw at 0.05 ppm; and combined residues of flucarbazone-
sodium and its metabolites converted to 2-(trifluoromethoxy) benzene
sulfonamide and calculated as flucarbazone-sodium in or on milk at
0.005 ppm; meat and meat byproducts (excluding liver) of cattle, goats,
hogs, horses, and sheep at 0.01 ppm; and liver of cattle, goats, hogs,
horses, and sheep at 1.5 ppm. The tolerance will expire on November 1,
2005.
    In the Federal Register of July 27, 2005 (70 FR 43412) (FRL-7727-
2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F6949) by Arysta LifeScience North America Corporation, 100 First
Street, Suite 1700, San Francisco, CA 94105. The petition requested
that 40 CFR 180.562 be amended by establishing a tolerance for combined
residues of the herbicide, flucarbazone-sodium, 4,5-dihydro-3-methoxy-
4-methyl-5-oxo-N-[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole
1-carboxamide, sodium salt and its N-desmethyl metabolite in or on
wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10
ppm; and wheat, straw at 0.05 ppm; and combined residues of
flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. This notice
included a summary of the petition prepared by Arysta LifeScience North
America Corporation, the registrant. Comments were received on the
notice of filing. EPA response to those comments is discussed in Unit
IV.D.
    The time limited-tolerance previously issued September 29, 2000 (65
FR 58364) (FRL-6745-9), will be extended for 13 months and will expire
on November 30, 2006. A time-limited tolerance will be issued due to
outstanding studies (independent laboratory validations of: Analytical
Method for the Determination O-Desmethyl MKH 6562 (Metabolite of MKH
6562 in Soil by High Performance Liquid Chromatography Tandem Mass
Spectrometry), Analytical Method for the Determination of MKH 6562 and
Metabolites NODT (N,O-dimethyltriazolinone), Sulfonic Acid and
Sulfonamide in Soil by High Performance Liquid Chromatography Tandem
Mass Spectrometry, and Analytical Method for the Determination of MKH
6562 and Three Metabolites in Groundwater by High Performance Liquid
Chromatography Tandem Mass Spectrometry) will be submitted to the
Agency by the registrant in January 2006.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of

the risk assessment process, see http://docket.epa.gov/edkpub/index.jsp
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of the FFDCA, for a tolerance for combined residues of
flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-
[2(trifluoromethoxy)phenyl] sulfonyl-1H-1,2,4-triazole 1-carboxamide,
sodium salt and its N-desmethyl metabolite in or on wheat, forage at
0.30 ppm; wheat, grain at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat,
straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its
metabolites converted to 2-(trifluoromethoxy) benzene sulfonamide and
calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and
meat byproducts (excluding liver) of cattle, goats, hogs, horses, and
sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep
at 1.5 ppm. EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by flucarbazone-sodium as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies can be found at http://docket.epa.gov/edkpub/index.jsp
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://docket.epa.gov/edkpub/index.jsp.

    A summary of the toxicological endpoints for flucarbazone-sodium
used for human risk assessment is discussed in Unit III.B. of the final
rule published in the Federal Register of September 29, 2000 (65 FR
58363) (FRL-6745-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established 40 CFR 180.562 for the combined residues of flucarbazone-
sodium, in or on wheat, forage at 0.30 ppm; wheat, grain at 0.01 ppm;
wheat, hay at 0.10 ppm; and wheat, straw at 0.05 ppm; and combined
residues of flucarbazone-sodium and its metabolites converted to 2-
(trifluoromethoxy) benzene sulfonamide and calculated as flucarbazone-
sodium in or on milk at 0.005 ppm; meat and meat byproducts (excluding
liver) of cattle, goats, hogs, horses, and sheep at 0.01 ppm; and liver
of cattle, goats, hogs, horses, and sheep at 1.5 ppm. Risk assessments
were conducted by EPA to assess dietary exposures from flucarbazone-
sodium in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a one day or single exposure. The Dietary Exposure
Evaluation Model (DEEM\TM\) analysis evaluated the individual food
consumption as reported by respondents in the United States Department
of Agriculture (USDA) 1989-1992 Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity.
    A summary of the acute dietary exposure assessment is discussed in
Unit III.C. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
    ii. Chronic exposure. In conducting this chronic dietary exposure
and risk assessment the DEEM\TM\ analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 Nationwide
CSFII and accumulated exposure to the chemical for each commodity.
    A summary of the chronic dietary exposure assessment is discussed
in Unit III.C. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
    iii. Cancer. A summary of the dietary exposure assessment is
discussed in Unit III.C. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
    Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available
data and information on the anticipated residue levels of pesticide
residues in food and the actual levels of pesticide chemicals that have
been measured in food. If EPA relies on such information, EPA must
require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. As required by section 408(b)(2)(E) of the
FFDCA, EPA will issue a Data Call-In for information relating to
anticipated residues to be submitted no later than 5 years from the
date of issuance of this tolerance.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flucarbazone-sodium in
drinking water. Because the Agency does not have comprehensive
monitoring data, drinking water concentration estimates are made by
reliance on simulation or modeling taking into account data on the
physical characteristics of flucarbazone-sodium. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://docket.epa.gov/edkpub/index.jsp.

    A summary of the dietary exposure from drinking water assessment is
discussed in Unit III. C. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
    Based on the generic expected environmental concentration (GENEEC)
and screening concentration in ground water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of flucarbazone-sodium
for acute exposures are estimated to be 1.42 parts per billion (ppb)
for surface water and

0.2 ppb for ground water. The EECs for chronic exposures are estimated
to be 1.25 ppb for surface water and 0.2 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flucarbazone-sodium is not registered for use on any sites that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to flucarbazone-sodium and
any other substances and flucarbazone-sodium does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
flucarbazone-sodium has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at  http://www.epa.gov/pesticides/cumulative/
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
    2. Prenatal and postnatal sensitivity. A summary of the prenatal
and postnatal sensitivity assessment is discussed in Unit III.D. of the
final rule published in the Federal Register of September 29, 2000 (65
FR 58363).
    3. Conclusion. There is a complete toxicity data base for
flucarbazone-sodium and exposure data are complete or are estimated
based on data that reasonably accounts for potential exposures. A
summary of the safety factor is discussed in Unit III.D. of the final
rule published in the Federal Register of September 29, 2000 (65 FR
58363).

E. Aggregate Risks and Determination of Safety

    1. Acute risk. A summary of the acute risk assessment is discussed
in Unit III.E. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
    2. Chronic risk. A summary of the chronic risk assessment is
discussed in Unit III.E. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
    3. Short-term risk. A summary of the short-term risk assessment is
discussed in Unit III.E. of the final rule published in the Federal
Register of September 29, 2000 (65 FR 58363).
    4. Intermediate-term risk. A summary of the intermediate-term risk
assessment is discussed in Unit III.E. of the final rule published in
the Federal Register of September 29, 2000 (65 FR 58363).
    5. Aggregate cancer risk for U.S. population. A summary of the
aggregate cancer risk for U.S. population assessment is discussed in
Unit III.E. of the final rule published in the Federal Register of
September 29, 2000 (65 FR 58363).
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to flucarbazone-sodium residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The petitioner has proposed residue analytical methods for
tolerance enforcement in wheat and livestock commodities. The
analytical enforcement method for wheat employs accelerated solvent
extraction, clean-up using solid phase extraction columns followed by
detection and quantitation by liquid chromatography/tandem mass
spectroscopy (LC/MS/MS). The analytical method for livestock
commodities is a common moiety method which measures residues of
flucarbazone-sodium (MKH6562) in animal tissues and milk by extracting
and hydrolyzing MKH 6562 and MKH 6562-related residues to MKH 6562
sulfonamide. Detection is achieved using negative ion electrospray mass
spectrometry using deuterated MKH 6562 sulfonamide as an internal
standard. Both methods have undergone successful validations by
independent laboratories and have been accepted by the Agency. The
analytical standards for these methods are available from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    A default Maximum Residue Limit (MRL) of 0.01 ppm has been
established in Canada for residues of flucarbazone-sodium and its N-
desmethyl metabolite on wheat grain. This value is consistent with the
tolerance being established in the United States on wheat grain. There
are no Codex MRLs for this compound on wheat. Therefore, no
compatibility issues exist with Codex in regard to the U.S. tolerances
discussed in this review.

C. Conditions

    None.

D. Comments

    Public comments were received from B. Sachau who objected to the
proposed tolerances because of the supposed harmful effects to the
human genes. B. Sachau's comments contained no scientific data or
evidence to rebut the Agency's conclusion that there is a reasonable
certainty that no harm will result from aggregate exposure to
flucarbazone-sodium including all anticipated dietary exposures and all
other exposures for which there is reliable information. EPA has
responded to B. Sachau's generalized comments on numerous previous
occasions. 70 FR 1349, 1354 (January 7, 2005); 69 FR 63083, 63096
(October 29, 2004).

V. Conclusion

    Therefore, the time-limited tolerance (expires November 30, 2006)
is established for combined residues of flucarbazone-sodium, 4,5-
dihydro-3-methoxy-4-methyl-5-oxo-N-[2(trifluoromethoxy)phenyl]
sulfonyl-1H-1,2,4-triazole 1-carboxamide, sodium salt and its N-
desmethyl metabolite, in or on wheat, forage at 0.30 ppm; wheat, grain
at 0.01 ppm; wheat, hay at 0.10 ppm; and wheat,

straw at 0.05 ppm; and combined residues of flucarbazone-sodium and its
metabolites converted to 2-(trifluoromethoxy) benzene sulfonamide and
calculated as flucarbazone-sodium in or on milk at 0.005 ppm; meat and
meat byproducts (excluding liver) of cattle, goats, hogs, horses, and
sheep at 0.01 ppm; and liver of cattle, goats, hogs, horses, and sheep
at 1.5ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d),
as was provided in the old sections 408 and 409 of the FFDCA. However,
the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2005-0254 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before January
9, 2006.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is<PHONE_NUMBER>.
    2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2005-0254, to: Public
Information and Records Integrity Branch, Information Technology and
Resources Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to<EMAIL_ADDRESS>
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of

regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 28, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.562 is revised to read as follows:

Sec.  180.562   Flucarbazone-sodium; tolerances for residues.

    (a) General. (1) Time-limited tolerances are established for
combined residues of the herbicide flucarbazone-sodium, 4,5-dihydro-3-
methoxy-4-methyl-5-oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-
1,2,4-triazole 1-carboxamide, sodium salt) and its N-desmethyl
metabolite in or on the following food commodities:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Wheat, forage...................  0.30..............  11/30/06
Wheat, grain....................  0.01..............  11/30/06
Wheat, hay......................  0.10..............  11/30/06
Wheat, straw....................  0.05..............  11/30/06
------------------------------------------------------------------------

    (2) Time-limited tolerances are established for combined residues
of the herbicide flucarbazone-sodium, 4,5-dihydro-3-methoxy-4-methyl-5-
oxo-N-[[2(trifluoromethoxy)phenyl] sulfonyl]-1H-1,2,4-triazole 1-
carboxamide, sodium salt) and its metabolites converted to 2-
(trifluoromethoxy)benzene sulfonamide and calculated as flucarbazone-
sodium in or on the following food commodities:

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    Revocation Date
------------------------------------------------------------------------
Cattle, liver...................  1.50..............  11/30/06
Cattle, meat....................  0.01..............  11/30/06
Cattle, meat byproducts except    0.01..............  11/30/06
 liver.
Goat, liver.....................  1.50..............  11/30/06
Goat, meat......................  0.01..............  11/30/06
Goat, meat byproducts except      0.01..............  11/30/06
 liver.
Hog, liver......................  1.50..............  11/30/06
Hog, meat.......................  0.01..............  11/30/06
Hog, meat byproducts except       0.01..............  11/30/06
 liver.
Horse, liver....................  1.50..............  11/30/06
Horse, meat.....................  0.01..............  11/30/06
Horse, meat byproducts except     0.01..............  11/30/06
 liver.
Milk............................  0.005.............  11/30/06
Sheep, liver....................  1.50..............  11/30/06
Sheep, meat.....................  0.01..............  11/30/06
Sheep, meat byproducts except     0.01..............  11/30/06
 liver.
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]

[FR Doc. 05-22254 Filed 11-8-05; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: April 4, 2008 (Volume 73, Number 66)]
[Rules and Regulations]
[Page 18437-18438]
[DOCID:fr04ap08-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-0342; Airspace Docket No. 07-AAL-20]

Revision of Class E Airspace; Bettles, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action revises Class E airspace at Bettles, AK to provide
adequate controlled airspace to contain aircraft executing Standard
Instrument Approach Procedures (SIAPs). Two Standard Instrument
Approach Procedures (SIAPs) are being developed for the Bettles
Airport. Additionally, two SIAPs and a textual departure procedure (DP)
are being amended. This action revises existing Class E airspace upward
from the surface and from 700 feet (ft.) and 1,200 ft. above the
surface at the Bettles Airport, Bettles, AK.

EFFECTIVE DATE: 0901 UTC, June 5, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Gary Rolf, AAL-538G, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.alaska.faa.gov/at.

SUPPLEMENTARY INFORMATION:

History

    On Friday, February 1, 2008, the FAA proposed to amend part 71 of
the Federal Aviation Regulations (14 CFR part 71) to revise Class E
airspace upward from the surface and from 700 ft. above the surface and
from 1,200 ft. above the surface at Bettles, AK (73 FR 6060). The
action was proposed in order to create Class E airspace sufficient in
size to contain aircraft while executing SIAPs for the Bettles Airport.
Class E controlled airspace extending upward from the surface and from
700 ft. above the surface and from 1,200 ft. above the surface, in the
Bettles Airport area is revised by this action.
    Interested parties were invited to participate in this rulemaking
proceeding by submitting written comments on the proposal to the FAA.
No comments were received. The rule is adopted as proposed.
    The area will be depicted on aeronautical charts for pilot
reference. The coordinates for this airspace docket are based on North
American Datum 83. The Class E airspace areas designated as surface
areas are published in paragraph 6002 of FAA Order 7400.9R, Airspace
Designations and Reporting Points, signed August 15, 2007, and
effective September 15, 2007, which is incorporated by reference in 14
CFR 71.1. The Class E airspace areas designated as 700/1,200 ft.
transition areas are published in paragraph 6005 of FAA Order 7400.9R,
Airspace Designations and Reporting Points, signed August 15, 2007, and
effective September 15, 2007, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.

The Rule

    This amendment to 14 CFR part 71 revises Class E airspace at the
Bettles Airport, Alaska. This Class E airspace is revised to
accommodate aircraft executing new and amended DPs and SIAPs, and will
be depicted on aeronautical charts for pilot reference. The intended
effect of this rule is to provide adequate controlled airspace for

Instrument Flight Rules (IFR) operations at the Bettles Airport,
Bettles, Alaska.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule will not have a significant economic impact on
a substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it creates Class E airspace sufficient in size to contain aircraft
executing instrument procedures for the Bettles Airport and represents
the FAA's continuing effort to safely and efficiently use the navigable
airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS; AIRWAYS; ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, and effective September 15, 2007, is
amended as follows:
* * * * *
Paragraph 6002 Class E Airspace Designated as Surface Areas.
* * * * *

AAL AK E2 Bettles, AK [Revised]

Bettles Airport, AK
    (Lat. 66[deg]54'50'' N., long. 151[deg]31'44'' W.)

    Within a 5.7-mile radius of the Bettles Airport. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Supplement
Alaska Airport/Facility Directory.

Paragraph 6005 Class E airspace extending upward from 700 feet or
more above the surface of the earth.

* * * * *

AAL AK E5 Bettles, AK [Revised]

Bettles Airport, AK
    (Lat. 66[deg]54'50'' N., long. 151[deg]31'44'' W.)

    That airspace extending upward from 700 feet above the surface
within an 8.2-mile radius of the Bettles Airport, and within 3.9
miles either side of the 212[deg] bearing from the Bettles Airport,
extending from the 8.2-mile radius to 11.3 miles southwest of the
Bettles Airport; and that airspace extending upward from 1,200 feet
above the surface within a 72-mile radius of the Bettles Airport.
* * * * *

    Issued in Anchorage, AK, on March 24, 2008.
Anthony M. Wylie,
Manager, Alaska Flight Services Information Area Group.
[FR Doc. E8-6932 Filed 4-3-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53464-53465]
[FR Doc No: 2018-23119]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR19-2-000]

EPIC Crude Pipeline, LP; Notice of Petition for Declaratory Order

    Take notice that on October 10, 2018, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's

(Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2)
(2018), EPIC Crude Pipeline, LP (EPIC Crude), filed a petition for
declaratory order seeking approval of the overall tariff and rate
structure, terms of service, and open season procedures for a new 730-
mile pipeline system that will originate in Orla, Texas and transport
crude petroleum produced in the Permian Basin to points of
interconnection with terminals located in Orla, Saragosa, Crane, Wink,
Midland, Helen, and Gardendale, Texas as well as the Port of Corpus
Christi, which will provide export access, all as more fully explained
in the petition.
    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, 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 on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    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 5 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 website that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
[email protected], or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on November 16, 2018.

    Dated: October 16, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-23119 Filed 10-22-18; 8:45 am]
 BILLING CODE 6717-01-P


Lydia Wegman/RTP/USEPA/US

11/28/2007 03:23 PM

To

<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Charlotte Bertrand/DC/USEPA/US@EPA, Mike Clark/DC/USEPA/US@EPA

cc

<EMAIL_ADDRESS><EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA, Zachary Pekar/RTP/USEPA/US@EPA

Subject

Redline Lead ANPR

Heidi and others,

Please find attached our redline version of the ANPR.  We believe we have addressed all your comments.  There is language in redline on pages 119-120 which is still the subject of discussion within the Agency, so it is possible that I will send you additional changes to that language within an hour or so.   Please give me a call as soon as you've had a chance to review the redline.  Thanks.

----- Forwarded by Lydia Wegman/RTP/USEPA/US on 11/28/2007 03:19 PM -----

Karen Martin/RTP/USEPA/US

11/28/2007 03:17 PM

To

Wegman Lydia@EPA, Murphy Deirdre@EPA, Zachary Pekar/RTP/USEPA/US@EPA

cc

Subject

Redline Lead ANPR -- pdf file

Karen Martin, Ph.D.

Office of Air Quality Planning and Standards

U.S. EPA (C504-06)

Research Triangle Park, NC 27711

phone:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

<EMAIL_ADDRESS>


[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39918-39919]
[FR Doc No: 2020-14269]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-P-1072]

Determination That ZOVIRAX (Acyclovir) Oral Capsules, 200
Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ZOVIRAX (acyclovir) oral capsules, 200 milligrams (mg),
was not withdrawn from sale for reasons of safety or effectiveness.
This determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will also allow FDA to continue to approve
ANDAs that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Jessica Tierney, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-9120<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).

    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ZOVIRAX (acyclovir) oral capsules, 200 mg, is the subject of NDA
018828, held by Mylan Pharmaceuticals Inc., and initially approved on
January 25, 1985. ZOVIRAX is indicated for the acute treatment of
herpes zoster (shingles), the treatment of initial episodes and the
management of recurrent episodes of genital herpes, and the treatment
of chickenpox (varicella).
    ZOVIRAX (acyclovir) oral capsules, 200 mg, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
Yiling Pharmaceuticals Ltd. submitted a citizen petition dated March
10, 2020 (Docket No. FDA-2020-P-1072), under 21 CFR 10.30, requesting
that the Agency determine whether ZOVIRAX (acyclovir) oral capsules,
200 mg, was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ZOVIRAX (acyclovir) oral capsules, 200 mg, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that ZOVIRAX
(acyclovir) oral capsules, 200 mg, was withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of ZOVIRAX (acyclovir) oral capsules, 200 mg,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have reviewed the
available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list ZOVIRAX (acyclovir)
oral capsules, 200 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug may also be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: June 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14269 Filed 7-1-20; 8:45 am]
BILLING CODE 4164-01-P