[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43537-43539]
[FR Doc No: 2017-19822]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9966-42-OAR]

Allocations of Cross-State Air Pollution Rule Allowances From New
Unit Set-Asides for the 2017 Compliance Year

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of data availability (NODA).

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SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of the availability of data on emission allowance allocations to
certain units under the Cross-State Air Pollution Rule (CSAPR). EPA has
completed final calculations for the first round of allocations of
allowances from the CSAPR new unit set-asides (NUSAs) for the 2017
control periods and has posted spreadsheets containing the calculations
on EPA's Web site. The only change from the preliminary calculations is
the elimination of allocations of CSAPR SO2 Group 2
allowances to four units in Georgia that for purposes of the
preliminary calculations were incorrectly identified as new units
instead of existing units.

DATES: September 18, 2017.

FOR FURTHER INFORMATION CONTACT: Questions concerning this action
should be addressed to Robert Miller at<PHONE_NUMBER> or
<EMAIL_ADDRESS>or to Kenon Smith at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under each CSAPR trading program where EPA
is responsible for determining emission allowance allocations, a
portion of each state's emissions budget for the program for each
control period is reserved in a NUSA (and in an additional Indian
country NUSA in the case of states with Indian country within their
borders) for allocation to certain units that would not otherwise
receive allowance allocations. Each NUSA allowance allocation process
involves up to two rounds of allocations to eligible units, termed
``new'' units, followed by the allocation to ``existing'' units of any
allowances not allocated to new units.\1\ In a NODA published in the
Federal Register on June 21, 2017 (82 FR 28243), we provided notice of
preliminary calculations for the first-round 2017 NUSA allowance
allocations. We also described the process for submitting any
objections to the preliminary calculations. This NODA concerns the
final calculations for this round of 2017 NUSA allocations.
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    \1\ The procedures for annually allocating allowances from each
NUSA to eligible units are set forth in the CSAPR regulations at 40
CFR 97.411(b) and 97.412 (CSAPR NOX Annual Trading
Program), 97.511(b) and 97.512 (CSAPR NOX Ozone Season
Group 1 Trading Program), 97.611(b) and 97.612 (CSAPR SO2
Group 1 Trading Program), 97.711(b) and 97.712 (CSAPR SO2
Group 2 Trading Program), and 97.811(b) and 97.812 (CSAPR
NOX Ozone Season Group 2 Trading Program).
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    EPA received written objections from four parties in response to
the June 21

NODA.\2\ For the reasons discussed below, we have concluded that none
of the written objections provides a valid basis for altering the
preliminary calculations of NUSA allowance allocations.
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    \2\ A fifth written objection was withdrawn prior to EPA's
drafting of this notice.
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    The first written objection was submitted by a representative for a
combustion turbine that commenced commercial operation in 2007 in
simple cycle configuration and that in 2016 was modified to combined
cycle configuration through the installation of additional equipment
including a heat recovery steam generator, duct burners, and a steam
turbine. According to the objection, the additional equipment should be
treated for CSAPR purposes as a separate, new affected unit that is
eligible for allocations of CSAPR NUSA allowances.\3\
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    \3\ The objection seeks NUSA allocations of CSAPR NOX
Annual, CSAPR SO2 Group 2, and CSAPR NOX Ozone
Season Group 2 allowances. However, the facility is located in
Kansas, and allocations of 2017 CSAPR NOX Annual
allowances to units in Kansas are governed by a SIP revision rather
than by the allocation procedures in the federal CSAPR regulations.
81 FR 42256 (June 29, 2016). EPA therefore addresses the objection
only as it relates to allowances for the remaining two programs.
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    EPA disagrees with this objection based primarily on our
interpretation of the CSAPR definitions of ``combustion turbine'' and
``unit.'' The CSAPR definition of ``combustion turbine'' covers two
possible equipment configurations--the equipment required for simple
cycle operation, consisting of a compressor, combustor, and turbine,
and the equipment required for combined cycle operation, consisting of
the preceding equipment plus a heat recovery steam generator, duct
burners (if any), and a steam turbine.\4\ The facility in question
meets the CSAPR definition of ``combustion turbine'' both before and
after the addition of the new equipment described above; the effect of
adding the new equipment is simply to cause the facility to meet a
different provision of the definition. Nothing in the definition
suggests that the addition of equipment to a given facility that causes
a different provision of the definition to apply should be interpreted
as splitting that facility into two separate combustion turbines, as
the objection claims. Moreover, our interpretation that the facility in
question remains a single combustion turbine is strongly supported by
the CSAPR definition of ``unit,'' which encompasses a ``combustion
turbine'' and further states in relevant part that ``[a] unit that
undergoes a physical change . . . shall continue to be treated as the
same unit.'' \5\ The objection asserts that this definition means that
only the original equipment is ``the same unit,'' while the additional
equipment comprising the ``physical change'' is a separate unit, but we
disagree. To the contrary, we believe a plain reading of the definition
indicates that a unit to which a physical change has been made remains
``the same unit'' but with a physical change.
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    \4\ The full definition states: ``Combustion turbine means an
enclosed device comprising: (1) If the device is simple cycle, a
compressor, a combustor, and a turbine and in which the flue gas
resulting from the combustion of fuel in the combustor passes
through the turbine, rotating the turbine; and (2) If the device is
combined cycle, the equipment described in paragraph (1) of this
definition and any associated duct burner, heat recovery steam
generator, and steam turbine.'' 40 CFR 97.702, 97.802.
    \5\ The full definition states: ``Unit means a stationary,
fossil-fuel-fired boiler, stationary, fossil-fuel-fired combustion
turbine, or other stationary, fossil-fuel-fired combustion device. A
unit that undergoes a physical change or is moved to a different
location or source shall continue to be treated as the same unit. A
unit (the replaced unit) that is replaced by another unit (the
replacement unit) at the same or a different source shall continue
to be treated as the same unit, and the replacement unit shall be
treated as a separate unit.'' 40 CFR 97.702, 97.802.
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    In summary, we interpret the CSAPR regulations as providing that
the facility in question remains the same, single ``combustion
turbine'' for CSAPR purposes after the addition of the new equipment as
it was before the addition of the new equipment.\6\ Because we do not
agree that the additional equipment should be treated as a separate,
new affected unit for CSAPR purposes, it is unnecessary to address the
portions of the objection concerning the quantities of NUSA allowances
for which such a new unit theoretically would be eligible.
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    \6\ EPA further notes that the facility's representatives have
not complied with multiple CSAPR requirements that would apply if
the additional equipment in fact did constitute a separate, new
affected unit for CSAPR purposes. For example, they have not
submitted a certificate of representation identifying the additional
equipment as a new affected unit, see 40 CFR 97.415(d), 97.715(d),
97.815(d), have not submitted a monitoring plan identifying such a
new unit (or identifying the new stack as a common stack serving
multiple units), see Sec. Sec.  97.434(b), 97.734(b), 97.834(b), and
have not reported any separate hourly emissions or heat input data
for such a new unit, see Sec. Sec.  97.434(d), 97.734(d), 97.834(d).
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    The second and third written objections were submitted by
representatives of two facilities whose units are treated as new units
for purposes of the original CSAPR trading programs but are treated as
existing units for purposes of the more recent CSAPR NOX
Ozone Season Group 2 trading program. The units in question commenced
commercial operation in 2011 and 2012 and their owners have identified
them as affected by CSAPR. In the CSAPR rulemaking finalized in 2011
that established the original four CSAPR trading programs, EPA
determined that all likely affected units that commenced commercial
operation prior to January 1, 2010 should be treated as existing units
for purposes of these four trading programs.\7\ In the CSAPR Update
rulemaking finalized in 2016 that established the CSAPR NOX
Ozone Season Group 2 Trading Program, we determined that all likely
affected units that commenced commercial operation prior to January 1,
2015 should be treated as existing units for purposes of this trading
program.\8\ Under these criteria, the units in question are new units
for purposes of the original four CSAPR trading programs and existing
units for purposes of the CSAPR NOX Ozone Season Group 2
Trading Program. The facilities' representatives object to the units'
classification as existing units under this last trading program and
request that the units be classified instead as new units eligible for
allocations of NUSA allowances under this program.
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    \7\ 76 FR 48208, 48288-91 (August 8, 2011).
    \8\ 81 FR 74504, 74563-66 (October 26, 2016).
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    As noted above, allocations of NUSA allowances under the CSAPR
NOX Ozone Season Group 2 Trading Program are governed by 40
CFR 97.811(b) and 97.812. The regulations provide a detailed set of
procedures that EPA must follow when allocating NUSA allowances,
including procedures for identifying the units eligible for each round
of NUSA allocations for each control period. Under Sec.
97.811(b)(1)(ii)(B), objections to our preliminary calculations of
first-round allocations ``shall be limited to addressing whether the
calculations (including the identification of the CSAPR NOX
Ozone Season Group 2 units) are in accordance with Sec.  97.812(a)(2)
through (7) and (12) and Sec. Sec.  97.830 through 97.835''--in other
words, whether the calculations (including identification of eligible
units) have been performed in accordance with the detailed procedures
set forth in the regulations. The objections to the June 21 NODA fall
outside this narrow scope. The January 1, 2015 cutoff date used to
determine whether a particular unit is an existing unit for purposes of
this trading program was established as part of the CSAPR Update
rulemaking and can be revised only through another rulemaking. The
process of allocating NUSA allowances is strictly an administrative
process that implements regulations already in effect, not a

rulemaking process in which regulations may be revised.
    EPA has confirmed that the units in question are not eligible to
receive allocations of NUSA allowances under the regulations for the
CSAPR NOX Ozone Season Group 2 Trading Program. Under Sec.
97.812(a)(3), first-round allocations are determined for ``each CSAPR
NOX Ozone Season Group 2 unit described in paragraph (a)(1)
of this section''--i.e., Sec.  97.812(a)(1). This paragraph of the
regulations identifies three categories of units eligible for first-
round allocations: First, units that have not been allocated allowances
as existing units pursuant to Sec.  97.811(a)(1); second, units that
have been allocated allowances as existing units from a given state's
budget for a given control period but have lost those allocations under
the trading program's correction provisions (because the units either
are not located in that state or are not subject to the program at the
start of that control period); and third, units that have ceased
operation for a sufficient length of time to lose their allocations as
existing units and have subsequently resumed operation.\9\ As discussed
above, the units in question meet the criteria established in the CSAPR
Update rulemaking to be considered existing units for purposes of the
CSAPR NOX Ozone Season Group 2 Trading Program, and the
units accordingly have been allocated allowances as existing units
pursuant to Sec.  97.811(a)(1). The units do not fall within one of the
categories of units eligible for NUSA allocations as set forth in Sec.
97.812(a)(1), and the regulations do not provide us with the authority
either to grant exceptions for individual units or to identify
additional categories of eligible units beyond those set forth in Sec.
97.812(a)(1).
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    \9\ See Sec.  97.812(a)(1)(i), (ii), and (iii), respectively.
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    As an alternative to having the facility's units reclassified as
new units for purposes of the CSAPR NOX Ozone Season Group 2
Trading Program, the third written objection also seeks modifications
to the data used to compute the units' allocations of allowances as
existing units under that program. However, like the January 1, 2015
cutoff date, EPA's determinations of which data should be used to
determine allowance allocations to existing units were made in the
CSAPR Update rulemaking \10\ and can be revised only through another
rulemaking, not through the administrative process of allocating NUSA
allowances. The objection is therefore outside the scope of the June 21
NODA.
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    \10\ See 81 FR at 74564-65.
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    Finally, the fourth written objection seeks modifications to the
total amount of the NUSA for Oklahoma under the CSAPR NOX
Ozone Season Group 2 Trading Program. Again, EPA's determinations
regarding the NUSA total amounts were made in the CSAPR Update
rulemaking; further, the actual amounts are codified in the CSAPR
regulations.\11\ The total amount of the NUSA for Oklahoma can be
revised only through another rulemaking, not through the administrative
process of allocating NUSA allowances, so the objection is outside the
scope of the June 21 NODA.
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    \11\ See 81 FR at 74565; 40 CFR 97.810(a)(17)(ii).
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    In addition to the written objections discussed above, EPA also
received a telephone inquiry that led to the discovery of an error in
the preliminary calculations for NUSA allocations of CSAPR
SO2 Group 2 allowances. Specifically, because of incorrect
processing of a change in the plant code used to identify certain
existing units at the Wansley power plant in Georgia, Wansley CC units
6A, 6B, 7A, and 7B were incorrectly identified as new units eligible to
receive NUSA allocations. We have corrected the error and these units
are not allocated allowances as new units in the final calculations.
    The final unit-by-unit data and allowance allocation calculations
are set forth in Excel spreadsheets titled
``CSAPR_NUSA_2017_NOx_Annual_1st_Round_Final_Data'',
``CSAPR_NUSA_2017_NOx_OS_1st_Round_Final_Data'', and
``CSAPR_NUSA_2017_SO2_1st_Round_Final_Data'', available on EPA's Web
site at https://www.epa.gov/csapr/csapr-compliance-year-2017-nusa-nodas. The three spreadsheets show our final determinations of first-
round 2017 NUSA allocations under the CSAPR NOX annual,
CSAPR NOX ozone season (Group 1 and Group 2), and CSAPR
SO2 (Group 1 and Group 2) trading programs, respectively.
    EPA notes that an allocation or lack of allocation of allowances to
a given unit does not constitute a determination that CSAPR does or
does not apply to the unit. We also note that allocations are subject
to potential correction.

(Authority: 40 CFR 97.411(b), 97.511(b), 97.611(b), 97.711(b), and
97.811(b).)

    Dated: July 27, 2017.
Karen L. Orehowsky,
Acting Director, Clean Air Markets Division, Office of Atmospheric
Programs, Office of Air and Radiation.
[FR Doc. 2017-19822 Filed 9-15-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Rules and Regulations]
[Page 10372]
[FR Doc No: 2012-4019]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0049]

Drawbridge Operation Regulation; Sacramento River, Sacramento, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eleventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento,
CA. The deviation is necessary to allow the community to participate in
the 8th Annual Shamrock Half Marathon. This deviation allows the bridge
to remain in the closed-to-navigation position during the event.

DATES: This deviation is effective from 7:30 a.m. to 1:05 p.m. on March
11, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2012-0049 and are available online
by going to http://www.regulations.gov, inserting USCG-2012-0049 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email David H. Sulouff, Chief, Bridge Section, Eleventh Coast
Guard District; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The California Department of Transportation
has requested a temporary change to the operation of the Tower
Drawbridge, mile 59.0, Sacramento River, at Sacramento, CA. The Tower
Drawbridge navigation span provides a vertical clearance of 30 feet
above Mean High Water in the closed-to-navigation position. The draw
opens on signal from May 1 through October 31 from 6 a.m. to 10 p.m.
and from November 1 through April 30 from 9 a.m. to 5 p.m. At all other
times the draw shall open on signal if at least four hours notice is
given, as required by 33 CFR 117.189(a). Navigation on the waterway is
commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 7:30 a.m. to 1:05 p.m. on March 11, 2012 to allow the community to
participate in the 8th Annual Shamrock Half Marathon. This temporary
deviation has been coordinated with waterway users. There are no
scheduled river boat cruises or anticipated levee maintenance during
this deviation period. No objections to the proposed temporary
deviation were raised. Vessels that can transit the bridge, while in
the closed-to-navigation position, may continue to do so at any time.
In the event of an emergency the drawspan can be opened with 15 minutes
advance notice.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: January 3, 2012.
D.H. Sulouff,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2012-4019 Filed 2-21-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 25, 2007 (Volume 72, Number 79)]
[Notices]
[Page 20519-20520]
[DOCID:fr25ap07-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-361-001]

Maritimes & Northeast Pipeline, L.L.C.; Notice of Compliance
Filing

April 19, 2007.
    Take notice that on April 16, 2007, Maritimes & Northeast Pipeline,
L.L.C. (Maritimes) tendered for filing as part of its FERC Gas Tariff,
First Revised Volume No. 1, the tariff sheet attached to Appendix B to
the filing, with an effective date of November 1, 2008.
    Maritimes states that copies of the filing were served on parties
on the official service list in the above-captioned proceeding.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR

385.211). Protests to this filing 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. Such protests must be
filed in accordance with the provisions of Section 154.210 of the
Commission's regulations (18 CFR 154.210). Anyone filing a protest must
serve a copy of that document on all the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

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

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

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-7862 Filed 4-24-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Rules and Regulations]
[Page 4482-4485]
[DOCID:fr28ja10-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0047; Directorate Identifier 2009-SW-28-AD;
Amendment 39-16177; AD 2010-02-07]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Model SE3160, SA315B,
SA316B, SA316C, and SA319B Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment supersedes an existing airworthiness directive
(AD) for the specified Eurocopter France (Eurocopter) model
helicopters. The existing AD requires certain inspections of a main
rotor blade (blade) manufactured under a Parts Manufacturer Approval
under Supplemental Type Certificate (STC) SH778GL. The AD requires
inspecting each affected root end bolt (bolt) and bolt-hole for
corrosion or a crack on the blade root end fitting (fitting) or in a
bolt-hole. For certain serial-numbered blades, the AD also requires a
one-time pull test on each fitting and blade root end doubler (doubler)
to detect disbonding. This AD requires certain inspections for voids in
any doubler or fitting and for paint cracks along the forward and aft
edge of the blade fitting. Also, this AD requires inspecting the blade
tip weight housing attachment. This AD also requires replacing
unairworthy blades with airworthy blades. This amendment is prompted by
reports from the STC holder of disbonds at the fittings, doublers, and
the tip weight fitting. The actions specified by this AD are intended
to prevent blade failure and subsequent loss of control of the
helicopter.

DATES: Effective February 12, 2010.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of February 12, 2010.

    Comments for inclusion in the Rules Docket must be received on or
before March 29, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Phlight of Phancy Corp. (PPC), 791 Westport Parkway, Fort Worth, Texas
76177-4511, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://
www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: DOT/FAA Southwest Region, Martin R.
Crane, ASW-170, Aviation Safety Engineer, Rotorcraft Directorate,
Rotorcraft Certification Office, 2601 Meacham Blvd., Fort Worth, Texas
76137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On July 16, 2003, the FAA issued an
Emergency AD 2003-15-51. That Emergency AD was published as a final
rule on August 28, 2003 (68 FR 51681). The current AD requires certain
inspections of a blade manufactured under a PMA issued and based on STC
SH778GL. The AD requires inspecting each bolt and bolt-hole for
corrosion or a crack on the fitting or in a bolt-hole on each affected
blade. For certain serial-numbered blades, the AD also requires a one-
time pull test on each fitting and doubler to detect disbonding. That
action was prompted by a report from the blade manufacturer of the
discovery of a cracked blade. In that action, we stated that the cause
of the crack remained under investigation. That condition, if not
corrected, could result in failure of a blade and subsequent loss of
control of the helicopter.
    Since issuing that AD, bond failures continue to be found in
certain blades produced under a Parts Manufacturer Approval based on
STC SH778GL. These bond failures occurred even after the inspections
specified by Rotor Trends LLC Service Bulletin (SB) No. 01.03, dated
July 9, 2003 (Rotor Trends SB), and required by AD 2003-15-51. Pflight
of Phancy Corp. (PPC), the current STC holder, has issued Service
Bulletin No. SB L3160-P-001, dated May 20, 2009 (PPC SB), to supersede
the Rotor Trends SB. The PPC SB specifies visual and tap inspections of
the blade root fittings and doublers. The PPC SB also specifies
replacing certain blades that have voids or paint cracks and inspecting
the blade tip weight housing on the outboard end of the blade. Finally,
the PPC SB specifies removing all affected blades by May 20, 2010, or
500 hours time-in-service (TIS), whichever occurs first. This AD does
not require replacing the blades at 500 hours TIS. However, replacing
the affected blades with airworthy blades to which this AD does not
apply would be terminating action for the requirements of this AD.
    Since an unsafe condition has been identified that is likely to
exist or develop on other Eurocopter model helicopters of these same
type designs, this AD supersedes AD 2003-15-51 to require the
following:
     Within 10 hours TIS, inspect each affected blade in the
doublers for a void and in the forward and aft edges for a paint crack.
    [cir] If you do not find a void or paint crack in the doublers or
fitting, and the only void you find is isolated in a .25 inch edge band
of any doubler or a fitting, repeat the inspection at intervals not to
exceed 30 hours TIS.
    [cir] If you find a void in any doubler or either fitting not
isolated in a .25 inch band or a paint crack of any length along the
forward or aft edge of the fitting at certain blade stations, replace
the blade with an airworthy blade before further flight.
     Within 10 hours TIS, tap and visually inspect each
affected blade:
    [cir] Remove the paint, and coin tap inspect the upper and lower
surface of the No. 2 spar to tip weight housing bond for a bond void.
    [cir] Using a 10X or higher magnifying glass, visually inspect the
No. 1 spar around through pins for hole elongation, a crack in the
spar, and pin movement (pins should be flush with upper and lower spar
surfaces). Visually inspect the tip weight housing outboard face for
movement relative to the spar (tip weight housing should be flush with
the face of No. 1 and 2 spars).
    [cir] Measure the thickness of the upper and lower spar by using
calipers held against the face of the No. 1 spar in alignment with the
through pins.
    [cir] If you find any of the following, replace the blade with an
airworthy blade before further flight:
    [cir] A void between the No. 2 spar to tip weight housing;
    [cir] In the No. 1 spar, either a crack, an elongated through pin
hole, movement of a through pin, or a through pin that is not flush
with the spar surface;
    [cir] Movement of the tip weight housing or a tip weight housing
that is not flush with the No. 1 or 2 spar; or
    [cir] An upper or lower spar measures less than 0.045 inch.
    [cir] If you do not find any of these discrepancies, repeat the
inspection at intervals not to exceed 30 hours TIS.
     Replacing an affected blade with an airworthy blade, with
a serial number that is not included in the ``Applicability'' section
of this AD, constitutes terminating action for the requirements of this
AD.
    Do the actions by following the specified portions of the SB
described previously.
    The short compliance time involved is required because the
previously described critical unsafe condition can adversely affect the
controllability or structural integrity of the helicopter. Therefore,
inspecting each blade within 10 hours TIS, repeating the inspection at
intervals not to exceed 30 hours TIS, and replacing the blades as
necessary before further flight are very short compliance times, and
this AD must be issued immediately.
    Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in less than 30 days.
    The FAA estimates that this AD will affect 30 helicopters. The
required actions will take about 3 work hours to inspect a blade and 3
work hours to replace a blade at an average labor rate of $80 per work
hour. Required parts will cost about $50,000 per blade. There are three
blades per helicopter. Based on these figures, we estimate the total
cost impact of the AD on U.S. operators to be $3,588,640, assuming 71
blades are replaced.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment; however, we invite you to submit any written data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2010-0047; Directorate
Identifier 2009-SW-28-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the AD. We will consider all
comments received by the closing date and may amend the AD in light of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of our
docket Web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national Government and the States, or on the distribution of power
and responsibilities among the various levels of government. For the
reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

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.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (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. Section 39.13 is amended by removing Amendment 39-13276 (68 FR
51681, dated August 28, 2003), and by adding a new airworthiness
directive (AD), Amendment 39-16177, to read as follows:

2010-02-07 Eurocopter France: Amendment 39-16177. Docket No. FAA-
2010-0047; Directorate Identifier 2009-SW-28-AD. Supersedes AD 2003-
15-51, Amendment 39-13276, Docket No. 2003-SW-34-AD.

Applicability:

    Eurocopter France Model SE3160, SA315B, SA316B, SA316C, and
SA319B helicopters, with main rotor blade (blade) part number L3160-
100-01, serial number (S/N) 600 through 671 (except those identified
with both ``SB L3160-P-001A'' and ``SB L3160-P-001B'' next to the
blade data plate), produced under a Parts Manufacturer Approval
based on Supplemental Type Certificate SH778GL, installed,
certificated in any category.

Compliance:

    Required as indicated.
    To prevent failure of a blade and subsequent loss of control of
the helicopter, do the following:
    (a) Within 10 hours time-in-service (TIS), unless accomplished
previously, tap and visually inspect each blade, S/N 600 through
666, 668 through 669, and 671 (except those identified with ``SB
L3160-P-001A'' next to the blade data plate) in the root doublers
for a void and in the forward and aft edges for a paint crack in the
areas depicted in Figure 1 of Phlight of Phancy Corp. Service
Bulletin No. SB L3160-P-001, dated May 20, 2009 (SB), and by
following the Accomplishment Instructions, Part A, paragraph 2.a.
through 2.e., of the SB.
    (1) If there is no void or paint crack in the root doublers or
fitting, and the only void you find is isolated in the .25 inch edge
band of a doubler or a fitting as depicted in Figure 1 of the SB,
repeat the inspection at intervals not to exceed 30 hours TIS.
    (2) If you find a void in any doubler or any root fitting not
isolated to the .25 inch band as depicted in Figure 1 of the SB or a
paint crack of any length along the forward or aft edge of a root
fitting between Blade Stations 35.02 and 42.52, replace the blade
with an airworthy blade before further flight.
    (b) Within 10 hours TIS, unless accomplished previously, inspect
each blade, S/N 600 through 671 (except those identified with ``SB
L3160-P-001B'' next to the blade data plate), in the areas depicted
in Figures 2 and 3 and by following the Accomplishment Instructions,
Part B, of the SB as follows:
    (1) Remove the paint and coin tap inspect the upper and lower
surface of the No. 2 spar to tip weight housing bond as depicted in
Figure 2 of the SB for a bond void. Conduct the inspection by
following the Accomplishment Instructions, Part B, paragraphs 2.a.
through 2.e. of the SB.
    (2) Using a 10X or higher magnifying glass, visually inspect the
No. 1 spar around the through pins for hole elongation, a crack in
the spar, and pin movement (pins should be flush with upper and
lower spar surfaces). Visually inspect the tip weight housing
outboard face for evidence of movement relative to the spar (tip
weight housing should be flush with the face of No. 1 and 2 spars).
    (3) Measure the thickness of the upper and lower spar by using
calipers held against the face of the No. 1 spar in alignment with
the through pins as depicted in Figure 3 of the SB.
    (4) If you find any of the following, replace the blade with an
airworthy blade before further flight:
    (i) A void between the No. 2 spar and tip weight housing;
    (ii) In the No. 1 spar, either a crack, an elongated through
pinhole, movement of a through pin, or a through pin that is not
flush with the spar surface;
    (iii) Movement of the tip weight housing or a tip weight housing
that is not flush with the No. 1 and No. 2 spar; or
    (iv) An upper or lower spar with thickness less than 0.045 inch.
    (5) If you do not find any of the discrepancies identified in
paragraph (b)(4)(i) through (b)(4)(iv) of this AD, repeat the
inspections required by paragraph (b) of this AD at intervals not to
exceed 30 hours TIS.
    (c) Replacing an affected blade with an airworthy blade with a
serial number that is not included in the ``Applicability'' section
of

this AD constitutes terminating action for the requirements of this
AD.
    (d) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Rotorcraft Directorate, Rotorcraft
Certification Office, ATTN: DOT/FAA Southwest Region, Martin Crane,
ASW-170, Aviation Safety Engineer, 2601 Meacham Blvd., Fort Worth,
Texas 76137, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, for
information about previously approved alternative methods of
compliance.
    (e) Special flight permits will not be issued.
    (f) The Joint Aircraft System/Component (JASC) Code for the
subject of this AD is Code 6210: Main rotor blades.
    (g) Inspect the blades by following the specified portions of
the Phlight of Phancy Corp. Service Bulletin SB L3160-P-001, dated
May 20, 2009. The Director of the Federal Register approved this
incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from Phlight of Phancy Corp., 791 Westport
Parkway, Fort Worth, Texas 76177-4511, telephone<PHONE_NUMBER>, fax
817-491-6759. Copies may be inspected at the FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 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.
    (h) This amendment becomes effective on February 12, 2010.

    Issued in Fort Worth, Texas, on January 8, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-1157 Filed 1-27-10; 8:45 am]
BILLING CODE 4910-13-P


R3c. When the Agency fits distributions to various exposure values, the maximum value entered into the probabilistic models for a particular distribution is usually defined to be an upper percentile value such as the 99th percentile in order to ensure realistic input parameters. Recognizing that the Agency intends to perform sensitivity analyses to evaluate the effects of this truncation, please comment on the Agency's approach of truncating distributions that are input to the probabilistic models. Please comment on any other approaches that the Agency might use to evaluate uncertainties associated with choices about whether and where to truncate distributions.

Response The Panel agreed that distributions should not be truncated unless there is a strong physical or biological reason to set an upper or lower limit. Truncation may eliminate only 1%, say, of the population, but it may be the most interesting 1%. Under truncation, the means and standard deviations of the distributions will be less than the nominal values and the assumptions of the simulation will not be quite the same as advertised. Truncation rules need to be set out in the documentation. A sensitivity analysis, comparing output with and without truncation, would help answer this question.

INTEGRATION INTEGRATION QUESTION # 1 The cumulative risk assessment guidance describes key principles for conducting these risk assessments. One such principle is the need to consider the time frame of both the exposure ( e. g., When does exposure occur? What is the exposure duration?) and of the toxic effect ( e. g., What are the time to peak effects and the time to recovery? How quickly is the effect reversed?). EPA's Preliminary Cumulative Risk Assessment for the N methyl carbamates describes the current limitations in data and software to fully characterize the dynamic nature of exposure, effect, and recovery for this common mechanism group. In order to address these limitations, OPP performed an examination of the exposure patterns for records from the high end of exposure distribution and found that that a large fraction (~ 70%) of daily records contributing to the upper tail of the food exposure distribution represent single eating occasions. Regarding drinking water and residential/ non occupational exposure, EPA's preliminary assessment provided a characterization of the current availability regarding datasets and models and a description of the impact of these limitations on the risk estimates from specific exposure pathways ( i. e., drinking water, residential).

I1a. Please comment on clarity and adequacy of the risk characterization provided in the preliminary cumulative risk assessment. Are there important 53 of 63 aspects with respect to the strengths and weaknesses of the risk characterization other than the ones we identified?

Response The consensus of the Panel was that the cumulative risk analysis document, including the risk characterization, shows enormous progress since the last SAP review in February of this year. Even so, the next round would benefit from some additional background material to improve its accessibility to readers less familiar with the basic assumptions and features of the analysis. Some Panelists found the oral presentation of the risk characterization clearer and more helpful than the written version in the existing document. Finally, one Panelist suggested that, in light of the specific geographic focus of the high end risk analysis involving significant ground water exposures, it might be more appropriate to present this material as a descriptive scenario rather than emphasizing the limited geographic derivation of the underlying data.

The next report also would benefit from further thought about the application of the relative potency factor paradigm to a group of AChE inhibitors that inhibit cholinesterase on time scales that are short but somewhat different. The relatively rapid recovery of the inhibition and the consequently short time unit for analysis pose an enormous challenge for risk characterization. With daily possibilities for exposure and inhibition there are 365 ( or 366) opportunities per year for an adverse event to occur. Therefore a risk characterization document needs to discuss and explain why readers should focus on such alternatives as ( A) the worst day experienced by any individual in a one year period ( B) the entire life stage ( 0 2 years? 0 20 years?) when there might be unusual developmental susceptibility or ( C) through ( Z) other plausibly relevant exposure and risk descriptors. These are to some extent risk management judgments, but the risk characterization should be designed to frame and clarify the information that the risk manager and the public might reasonably consider, using the best technical insights we have into the likely dynamics of causation and the relevant dosimeters for adverse effects.

Other than AChE inhibition itself, the acute and readily apparent health effects from exposure to cholinesterase inhibitors go under the acronym SLUD. For these acute effects, experience indicates that a BMD10 for brain cholinesterase inhibition is a conservative ( health protective) value. Moreover, because of the short time between cholinesterase inhibition and the manifestation of these signs, it is reasonable to consider that peak cholinesterase inhibition levels are the causally relevant measure of internal dose for modeling the risk of adverse responses in individuals.

However, readily observable high dose effects are not the only, or even the most important responses of concern for population exposures to cholinesterase inhibitors. As recently reviewed by Slotkin ( 2004), cholinergic signaling plays a vital role in several phases of neurodevelopment including the migration of the cells that will become mature neurons to the locations in the brain ( and, likely, elsewhere) where they are needed; the formation of connections with other neurons, and the survival of the connections 54 of 63 ( synapses) through phases where unused connections are pared back and lost. It is possible that even subtle strengthening of the signaling via some cholinergic synapses will lead to survival of some connections in preference to other non cholinergic pathways, and therefore have subtle long term consequences for function. This theory is based on current understanding of fundamental processes of neurodevelopment. For representative research articles and reviews on this large topic, see Lauder ( 1985), Whitaker Azmitia ( 1991), Hohmann and Berger Sweeney ( 1998), Lauder and Schambra ( 1999), Weiss et al. ( 1998). We now know that " neurodevelopment" of this type is not restricted to fetal life, but continues well after birth. In fact, there is evidence that synaptic rearrangement, as well as the proliferation and planned death of neurons, continues well into adolescence in rats ( Bayer et al., 1982; Bayer, 1983) and also humans ( Huttenlocher, 1990).

Long term health effects may also result from the adaptation of cholinergic signaling systems to cholinesterase inhibition. There are several recent reports of unexpected long term effects from military and agricultural anticholinesterase agents, in some cases when exposures were insufficient to induce acute cholinergic signs ( Baker and Sedgwick, 1996; Kelly et al., 1997; Kassa et al. 2004; Tochigi et al. 2002; Abu Qare and Abou Donia, 2002; Yokoyama et al. 1998; Sanchez Santed et al. 2004; Jamal et al. 2002). Long term animal studies with military nerve agents have recently led to suggestions of a need to revise LOAELs determined on the basis of short term experiments ( VanHelden et al. 2003; 2004), even though the short term experiments utilized quite a mild effect ( changes in pupil size) as the measure of response. Neuroscientists on the Panel considered that longer term adaptive responses are unlikely unless cholinesterase inhibition reaches levels that alter synaptic physiology by overriding the margin of safety for cholinergic transmission. The Panel finds, however that the concern for subtle developmental and adaptive effects does warrant further discussion in the risk characterization, to help decision makers and the public put the Agency's choice of benchmark doses in perspective.

Suspected developmental and adaptive effects might be more directly dependent on a time weighted integral of cholinesterase inhibition than on peak inhibition levels on specific days. There is a relatively straightforward way that EPA can use information it has already developed to perform an alternative set of exposure assessments based on this " Area Under the Curve" of cholinesterase inhibition dosimeter. That is, the Agency can do a parallel set of exposure analyses using an alternative set of Relative Potency Factors that incorporate both the potency of each carbamate for producing peak inhibition, and the rate at which that inhibition is reversed ( at the lowest available doses in the experiments already analyzed by EPA).

In rats, the estimated reversal half lives for inhibition by carbamates vary widely and the associated 95% confidence limits suggest statistical significance among some pairs ( Table 1. B. 6). In particular, the reversal half life of the proposed index chemical, oxamyl ( 0.75h with tight confidence limits of 0.66h 0.88h) is much shorter than that of formetanate ( 4.05h, with confidence limits of 3.02h 5.44h) and methiocarb ( 2.77h, with 55 of 63 confidence limits of 1.91h 4.01h).

Table 1 below illustrates a simple approach to construct an alternative set of Relative Potency Factors ( these might be designated " RPF*") using a preliminary index of time integrated relative potencies. The index would simply consist of the product of the BMD based RPFs and the individual chemical half lives for cholinesterase inhibition reversal   renormalized so that, as before, the value for the index chemical is set at 1. Because oxamyl has the shortest half life for inhibition reversal, this approach tends to increase the relative potency factors for all the other compounds   by over 7 fold in the case of formetanate. Table 1 Preliminary Calculation of Time Integrated Relative Potency Factors ( RPF*) Peak BMDBased RPF Brain Inhib Reversal T1/ 2 ( hr) BMD* T1/ 2 Renormalized RPF* Relative to Oxamyl Aldicarb 3.32 1.52 5.05 6.73 Carbaryl ( 0 10 dose) 0.12 1.83 0.22 0.29 Carbofuran 1.19 2.49 2.96 3.95 Formetanate 1.89 5.4 10.21 13.6 Methiocarb 0.14 2.77 0.39 0.52 Methomyl 0.38 0.8 0.30 0.41 Oxamyl 1 0.75 0.75 1.00 Primicarb 0.02 1.90a 0.038a 0.051 Propoxur 0.09 2.69 0.24 0.32 Thiodicarb 0.7 1.90a 1.33a 1.77 aFor compounds with missing values for the inhibition reversal half life, the geometric mean of the half lives for other compounds ( 1.90) has been substituted in the calculation.

Some mechanistic reasoning and modeling could lead to modest further modifications to the RPF* calculations when translated into human equivalents. All of the N methyl carbamates are expected to leave behind the same chemical moiety on AChE. Purely spontaneous chemical reversal of the inhibition therefore is expected to occur at an identical rate across different carbamates in the common mechanism group, and should at least be similar across species from rats to humans. Data to confirm this expectation would not be difficult to obtain.

Given the similar behavior of the N methyl carbamates at the level of the target enzyme, the differences in their inhibition reversal half lives are likely to reflect differences in their rates of clearance from the body by excretion and metabolism. To the degree that a particular chemical's brain inhibition reversal does depend on this kind of slow clearance, then the ordinary scaling principles for metabolism based pharmacokinetics ( Travis et al. 1990; Boxenbaum, 1980 and 1982; Reese and Hattis, 1994) suggest that the clearance will be slower in people   according to convention, roughly in proportion to Body Weight raised to the 0.25 power. Thus, the baseline expectation is that this kind of 56 of 63 pharmacokinetic clearance should be about 4 times slower in a 70 kg person than in a 0.3 kg rat: ( 70/ 0.3) 0.25 = 4. To translate the rat brain inhibition reversal half lives to human equivalents, therefore, a factor of 4 might be applied to the chemicals whose brain inhibition reversal rate is markedly slower than the in vitro reactivation half lives that may be observed in experiments now under way. In cases where the estimated brain AChE inhibition reversal half lives are similar to those measured at the appropriate temperature in vitro, however, no such interspecies projection factor should be applied. If modeling studies indicate that the processes limiting the rate of inhibition reversal can be apportioned between the spontaneous chemical processes and clearance from the body reservoir( s), then of course the interspecies slowing factor should only be applied to the active metabolic clearance process. This circumstance could therefore eventually lead to some differential adjustment of the RPF* across species [ and, by extension, across age groups for the very young and the very old whose clearance rates tend to be less than those for young adults ( Ginsberg et al. 2002 and 2005). Meanwhile, these considerations suggest that the in vivo inhibition half lives for some N methyl carbamates might be long enough to call into question a basic assumption of the proposed cumulative risk assessment for this common mechanism group. In particular, if one applies a 4.1 fold inter species scaling factor to the 5.4 hr half time for reversal of brain AChE inhibition in rats, one obtains a predicted half time of 22 hr in the 70 kg human adult. Such a long half time would force the risk assessment model to address carryover of inhibition from one day to the next. In considering this issue, the Agency should take into account cases where there is a dose dependency for inhibition reversal half lives. In these cases, projections should utilize the estimates from the lowest feasible dose rate because it may be most relevant to the expectations for exposure at BMD10.

I1b. Is the Panel aware of additional data which would aid the Agency in its cumulative risk characterization for the N methyl carbamate pesticides? For example, is the Panel aware of any available data on the timing of water consumption events or can the Panel make any recommendations regarding reasonable assumptions that could be made to help characterize the estimated risk? Are there other sensitivity analyses and further investigations that would be equally or more important than the ones we identified?

Response In response to this question, and because of the clear importance of the local drinking water pathway to the analysis, the Panel has undertaken some very simple pharmacokinetic modeling on this subject. There is good reason to suspect that the current method of analysis   lumping all daily exposure into a single event   introduces a systematic distortion in the expected effects on peak inhibition levels between dietary exposure ( which, for upper percentiles, seem to be mostly traceable to single eating events per day) vs. drinking water, which clearly occurs in several different events distributed throughout the day. The Panel has asked itself, how might the RPFs for peak brain AChE 57 of 63 inhibition be adapted to accommodate a likely scenario for time dependent water consumption?

The following analysis is based on what the Panel understands to be one plausible pattern of diurnal drinking water consumption that the EPA uses for pharmacokinetic analyses. This pattern consists of three water consumption events ( each delivering 25% of daily consumption) at meal times separated by 5 hour intervals, and two between meal drinking events, each delivering 12.5% of daily consumption. Figure 5 compares the results of this consumption scenario for expected peak inhibition levels in rats following water intake of BMD10 amounts of the NMC with the longest inhibition reversal half life ( formetanate) and the NMC with the shortest half life ( oxamyl). ( The Panel has not attempted to incorporate further adjustments to translate results into half lives for general and special human subpopulations).

Figure 5 shows that this hypothesized pattern of drinking water exposure does indeed lead to quite different expectations for peak daily cholinesterase inhibition for the daily drinking water doses of the two NMCs. The 5.4 hour half life for formetanate leads to appreciable buildup during the day to about 5.9% inhibition, whereas the predicted peak inhibition for oxamyl is only a little more than the 2.5% expected from each mealtime drinking event considered separately. If inhibition did not reverse between events, of course, or if the total daily dose were delivered in one bolus, the expected peak inhibition would be 10%. Table 2 illustrates how this finding can be translated into a simple numerical adjustment to the Relative Potency Factors.

Figure 5 58 of 63 14 13 12 11 10 9 8 7 6 5 4 3 2 1 0 0 1 2 3 4 5 6 Expected Time Pattern of Brain Acetylcholinesterase Inhibition for a Drinking Water Pattern of Exposure to Formetanate ( Inhibition T1/ 2 = 5.4 Hours) vs Oxamyl ( Inhibition T1/ 2 = 0.75 Hours)

Hours After Start of Exposure ( Breakfast) % Brain ACHE Inhibition Maximum = 5.89%

Maximum = 2.65% Formetanate Oxamyl Table 2 Indicated Relative Potencies for Formetanate vs. Oxamyl for Maximal Daily Inhibition for a Drinking Water Pattern of Exposure Half Life ( hr) Maximum % Inhibition for BMD10 Exposure Formetanate 5.4 5.89 Oxamyl 0.75 2.65 Ratio 7.2 2.23 In Table 2, the 2.2 fold upward adjustment of the formetanate RPF relative to oxamyl is significant, but less than the full ratio of the two half lives that would be indicated if AUCs were the desired causal dosimeter for a particular type of toxic response. Alternatively, the overall RPF for oxamyl itself in drinking water might be adjusted downward to .265 of the RPF for oxamyl in the single oral doses expected for most high percentile dietary exposures. 59 of 63 In further development of this approach, EPA should make use of any reliable source of relevant empirical data on daily patterns of drinking water consumption; ideally adapted to the likely consumption behavior in specific regions or smaller areas of the country.

Other comments on the analysis:

The discontinuity that is apparent for some exposure routes between the end of the year vs. the beginning of the year needs to be resolved. It cannot be true that all pet collars are really applied on Jan 1; a more random day needs to be chosen for this and similar modes of exposure, with allowance for cross year exposures as needed to fully represent realistic patterns for the start of an exposure event vs. the day of actually delivered exposures.

Institutional ( e. g., school) and occupational exposures should be incorporated into the assessment.

It will become important to supplement whole and half brain data with measurements of causally relevant amounts and durations of AChE inhibition in brain regions that are mechanistically connected to specific developmental and other effects. Brain regions differ in basal levels of AChE, and may therefore differ somewhat in sensitivity to inhibition. Whole brain and half brain measurements are considered by some in the field to be the " wave of the past". On the other hand, data on region specific inhibition of AChE are currently quite limited, and it is recognized that such measurements are associated with much higher variability than those from whole brain. For these reasons there was no Panel consensus in favor of incorporating regional studies at this time.

One Panelist considered that the non dietary oral exposures were likely to be much more uncertain than other sources of exposure. If the EPA agrees, the next document might discuss the relative confidence of the analysis in the quantification of exposures by various routes, and consequent implications for research and risk management priorities.

Another topic for discussion in the next iteration of the document is the fact that areas of the country were chosen where carbamate residential exposure and use is likely to be higher than that in the rest of the country because of greater pest pressures, among other circumstances. This may suggest a scenario presentation rather than the implication of a full US South regional analysis. Other suggestions by individual Panelists included subpopulation analyses by ethnic groups, groups with different dietary habits ( e. g., vegetarians) and other categorizations of people that might be associated with differences in exposures. Such categorizations might ultimately be helpful in formulating options for information programs and other risk management efforts. 60 of 63 REFERENCES HAZARD Hammond, P., T. Jelacic, S. Padilla, and S. Brimijoin. 1996. Quantitative, video based histochemistry to measure regional effects of anticholinesterase pesticides in rat brain. Anal. Biochem. 241: 82 92.

WATER ( In response to question W1)

Liu G., S. Dai, Y. Qian, and Q. Gan. 2003. Experimental Study on Effect of Anion Surfactant on Degradation Rate of Aldicarb in Soil. Journal of Environmental Science and Health, Part B: Pesticides, Food Contaminants, and Agricultural Wastes 38: 405 416.

Ou, L. T., P. S. C. Rao, K. S. V. Edvardsson, P. E. Jessup, and A. G. Hornsby. 1988. Aldicarb degradation in sandy soils from different depths. Pesticide Science 23 ( 1): 1 12.

Steenhuis, T. S., S. Pacenka, and K. S. Porter. 1987. MOUSE: A Management Model for Evaluating Groundwater Contamination from Diffuse Surface Sources Aided by Computer Graphics. Appl. Agric. Res. 2: 277 289.

( In response to question W2)

Darnault, C. J. D., T. S. Steenhuis, P. Garnier, Y. J. Kim, M. B. Jenkins, W. C. Chiorse, P. C. Baveye, and J. Y. Parlange. 2004. Preferential flow and transport of Cryptosporidium parvum oocysts through the vadose zone: Experiments and modeling. Vadose Zone J. 3: 262 270.

Glass, R. J., G. H. Oosting, and T. S. Steenhuis. 1989. Preferential Solute Transport in Layered Homogeneous Sands as a Consequence of Wetting Front Instability. J. Hydrol. 110: 87 105.

Jarvis, N. J., M. Stahli, L. Bergstrom, and H. Johnsson. 1994. Simulation of dichlorprop and bentazon leaching in soils of contrasting texture using the MACRO model. J. Environ. Sci. Health, A 29( 6): 1255 1277.

Kim, Y. J., C. J. G. Darnault, N. O. Bailey, J. Y. Parlange, and T. S. Steenhuis. 2005. Equation for Describing Solute Transport in Field Soils with Preferential Flow Paths. Soil Science Society of America J. 69: 291 300.

Kung, K J. S. 1990. Preferential flow in a sandy vadose zone: 1. field observation. 61 of 63 Geoderma 46: 51 58.

Sadeghi, A. M., A. R. Isensee, and A. Shirmohammadi. 2000. Influence of soil texture and tillage on herbicide transport. Chemosphere 41: 1327 1332.

Selker, J. S., T. S. Steenhuis, and J. Y. Parlange. 1996. An engineering approach to fingered vadose pollutant transport. Geoderma 70: 197 206.

Shipitalo, M. J., W. M. Edwards, and W. A. Dick. 1990. Initial storm effects on macropore transport of surface applied chemicals in no till soil. Soil Science Society of America Journal 54( 6): 1530 1536.

Singh, P., R. Kanwar, K. E. Johnsen, and L. R. Ahuja. 1996. Calibration and evaluation of subsurface drainage component of RZWQM V. 2.5. Journal of Environmental Quality 25( 1): 56 63.

Steenhuis, T. S., C. Jackson, K. J. S. Kung, and W. H. Brutsaert. 1985. Measurement of Groundwater Recharge on Eastern Long Island. J. Hydrol. 79: 145 169.

Steenhuis, T. S. and W. H. van der Molen. 1986. The Thornthwaite Mather Procedure as a Simple Engineering Method to Predict Recharge. J. Hydrol. 84: 221 229.

RESIDENTIAL ( In response to question R3b)

Alpert, M. and H. Raiffa. 1982. A progress report on the training of probability assessors. in Judgment Under Uncertainty, Heuristics and Biases, D. Kahneman, P. Slovic, and A. Tversky, eds., Cambridge University Press. N. Y. pp. 294 305.

Hattis, D. and D. E. Burmaster. 1994. Assessment of variability and uncertainty distributions for practical risk analyses. Risk Analysis 14: 713 730.

Lichtenstein S. and B. Fischoff. 1977. Do those who know more also know more about how much they know? Organizational Behavior and Human Performance 20: 159 183.

Shlyakhter, A. I. and D. M. Kammen. 1992. Sea level rise or fall?" Nature 253: 25.

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INTEGRATION 62 of 63 Abou Donia, M. B. 2003. Organophosphorus ester induced chronic neurotoxicity. Arch. Environ. Health. 58( 8): 484 497.

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Lynn Calvin: I'm Lynn Calvin, I'm actually an EPA person from a region. Isn't that education and training language, David,

from the ISO 9000 language?

David Schwarz: It may be. Some of it. I'm sure that we pulled things from a variety of sources, so it's possible that that's where it's from.

Lynn Calvin: Okay, I'll pursue that later. But that phrase sounded, if it isn't ISO 9000, there's stuff real like it in ISO 9000.

David Schwarz: Let me ask you a question. If it is in ISO 9000, does that have any implications we should be aware of?

Lynn Calvin: Well, if entities are ISO 9000 certified, they have some baseline records management in place. And basically they have policies and procedures for records management, 102 paper or electronic and some mechanism for monitoring that there is some compliance and education in those. That's part of what ISO 9000 does. It's at the 10,000 foot level, but it indicates that there is records management. And that's, but the CROMERRR language about education and training sounds like ISO 9000. I'm not sure.

John Bernstein: John Bernstein, I'm from EPA region 5. If the language is not from ISO 9000, it could very well be ISO 49, which is a records management standard that ISO has developed separate from 14000 and 9000.

David Schwarz: If some of these things are specified in ISO standards, are there EPA programs, whether through regulation or guidance, that refer to these ISO standards. Or is this just something that's out there that some people try to comply with?

John Bernstein: I would say it's the latter. Some people try and comply with them. On the other hand, it's my own feeling that businesses that do business internationally are trying to comply with ISO 9000, or for that matter 14000. I don't know how many businesses out there are complying. I haven't heard anything at least in my contact list with EPA.

David Schwarz: Okay, thanks.

David Keyes: This is David Keyes from Dow Agra Sciences. I 103 had talked to David a little earlier, but I wanted to ask this as officially: if you would be amenable to consider the 60 day extension for comments. Dick Lowery brought that up in his piece but I wanted to just make sure to ask that question separately.

Michael LeDesma: I guess the answer is, we can consider it.

I don't know what the real benefit would be. But if we decide to do that, we would publish a notice in the Federal Register that says we were going to do that.

Joe Retzer: I'm sorry, what's your special concern for why we need a longer comment period?

David Keyes: Just due to the far reaching scope and the amount of people that are involved with this. It's taking time to get everybody to get their comments in and be aware of this.

Deanna Heffron: I just wanted to make one comment. With some of the questions I realize that this proposed rule is just supposed to be a framework and allow for quite a bit of flexibility. ( inaudible)

End of Informal Hearing


[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Proposed Rules]
[Page 66347]
[FR Doc No: 2014-26527]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0540; FRL-9918-69]

Receipt of a Pesticide Petition Filed for Residues of Pesticide
Chemicals In or On Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petition and request for comment.

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

SUMMARY: This document announces the Agency's receipt of an initial
filing of a pesticide petition requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before December 8, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0540, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the agency taking?

    EPA is announcing receipt of a pesticide petition filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. The Agency is taking public comment on
the request before responding to the petitioner. EPA is not proposing
any particular action at this time. EPA has determined that the
pesticide petition described in this document contains data or
information prescribed in FFDCA section 408(d)(2), 21 U.S.C.
346a(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the pesticide petition. After considering the public comments, EPA
intends to evaluate whether and what action may be warranted.
Additional data may be needed before EPA can make a final determination
on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition that is the
subject of this document, prepared by the petitioner, is included in a
docket EPA has created for this rulemaking. The docket for this
petition is available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.
    PP 3E8182. Bayer CropScience, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709, requests to establish a tolerance in 40 CFR
part 180 for residues of the fungicide, Fosetyl-Al, aluminum tris (O-
ethyllphosphanate) in or on Pepper/Eggplant, subgroup 8-10B and Non-
bell (chili) pepper dried fruits at 0.01 parts per million (ppm). An
adequate enforcement method is used to measure and evaluate the
chemical aluminum tris (O-ethylphosphanate).

    Authority: 21 U.S.C. 346a.

    Dated: October 29, 2014.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2014-26527 Filed 11-6-14; 8:45 am]
BILLING CODE 6560-50-P