[Federal Register Volume 88, Number 24 (Monday, February 6, 2023)]
[Rules and Regulations]
[Pages 7568-7572]
[FR Doc No: 2023-02370]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1151; Project Identifier MCAI-2020-01603-T;
Amendment 39-22303; AD 2023-01-09]
RIN 2120-AA64

Airworthiness Directives; De Havilland Aircraft of Canada Limited
(Type Certificate Previously Held by Bombardier, Inc.) Airplanes

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

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain De Havilland Aircraft of Canada Limited Model DHC-8-400 series
airplanes. This AD was prompted by a report that electrical bonding
jumpers had been installed on fuel scavenge lines even after the
removal was required by previous AD rulemaking and that electrical
bonding jumpers may have been installed in production or in service at
other locations. This AD requires an inspection for electrical bonding
jumpers and brackets on the fuel scavenge and vent lines at specific
wing locations, and if installed, removal or modification of those
jumpers and brackets. This AD also requires a records check to
determine if certain maintenance tasks were performed and removal,
modification, or rework if those tasks were performed. This AD also
prohibits the use of earlier versions of certain maintenance tasks. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective March 13, 2023.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 13,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket

No. FAA-2022-1151; or in person at Docket Operations between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact De Havilland Aircraft of Canada Limited, Dash 8 Series Customer
Response Centre, 5800 Explorer Drive, Mississauga, Ontario, L4W 5K9,
Canada; telephone North America (toll-free):<PHONE_NUMBER>, Direct: 647-
277-5820; email dehavilland.com">[email protected]dehavilland.com; website dehavilland.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2022-1151.

FOR FURTHER INFORMATION CONTACT: Joseph Catanzaro, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain De Havilland
Aircraft of Canada Limited Model DHC-8-400, -401, and -402 airplanes.
The NPRM published in the Federal Register on September 9, 2022 (87 FR
55322). The NPRM was prompted by AD CF-2020-01, dated January 14, 2020,
issued by Transport Canada, which is the aviation authority for Canada
(referred to after this as the MCAI). The MCAI states it was reported
that electrical bonding jumpers had been installed on fuel scavenge
lines even after the removal was required by Transport Canada AD CF-
2010-31, dated September 3, 2010 (which corresponds to FAA AD 2011-13-
06, Amendment 39-16729 (76 FR 37258, June 27, 2011) (AD 2011-13-06)).
Subsequent investigation showed that electrical bonding jumpers may
have been installed in production or in service at other locations on
the fuel scavenge and vent lines. If installed, these electrical
bonding jumpers could affect the integrity of the fuel scavenge and
vent lines' electrical bonding paths, which may lead to lightning
strike induced fuel tank ignition.
    In the NPRM, the FAA proposed to require an inspection for
electrical bonding jumpers and brackets on the fuel scavenge and vent
lines at specific wing locations, and if installed, removal or
modification of those jumpers and brackets. The FAA also proposed to
require a records check to determine if certain maintenance tasks were
performed and removal, modification, or rework if those tasks were
performed. The FAA also proposed to prohibit the use of earlier
versions of certain maintenance tasks. The FAA is issuing this AD to
address altered electrical bonding paths, which may lead to lightning
strike-induced ignition of the fuel tank.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1151.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from the Air Line Pilots Association,
International (ALPA) who supported the NPRM without change.
    The FAA received additional comments from Horizon Air. The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Request To Remove Job Access and Close-up Requirements

    Horizon Air requested revising paragraphs (h)(1) and (2) of the
proposed AD to remove the Job Set-up and Close-Out sections of the
Accomplishment Instructions of Bombardier Service Bulletins 84-28-29
and 84-28-30, both dated October 17, 2018, from the requirements of the
proposed AD. Horizon Air asserted that incorporating the Job Set-up and
Close Out sections of the Accomplishment Instructions do not address
the unsafe condition and also restrict an operator's ability to perform
other maintenance in conjunction with the incorporation of the service
bulletins.
    In this case, the FAA agrees with the commenter's request to
exclude the ``Job Set-up'' and ``Close Out'' sections of Bombardier
Service Bulletin 84-28-29; and 84-28-30; both dated October 17, 2018.
The FAA has revised paragraphs (h)(1) and (2) of this AD to require
accomplishment of paragraph 3.B., ``Procedure,'' of the Accomplishment
Instructions of Bombardier Service Bulletins 84-28-29; or 84-28-30;
both dated October 17, 2018; as applicable.

Request To Correct Typographical Errors

    Horizon Air requested correction of some typographical errors it
found in paragraphs (h)(1) and (2) of the proposed AD. Horizon Air
noted that the dates provided for the referenced service bulletins was
published in the NPRM as October 1 instead of October 17 in two places.
Horizon Air also pointed out that in paragraph (h)(2) of the proposed
AD, the first reference to a service bulletin seems to be in error and
should be 84-28-30 instead of 84-28-29.
    The FAA acknowledges the typographical errors and agrees to the
request. Paragraphs (h)(1) and (2) of this AD have been revised as
requested.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comments received, and determined that air safety requires adopting
this AD as proposed. Accordingly, the FAA is issuing this AD to address
the unsafe condition on this product. Except for minor editorial
changes, this AD is adopted as proposed in the NPRM. None of the
changes will increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    De Havilland Aircraft of Canada Limited has issued Bombardier
Service Bulletins 84-28-29; and 84-28-30; both dated October 17, 2018;
which describe procedures for an inspection of certain wing stations in
the left and right wings for the presence of brackets and electrical
bonding jumpers on the fuel scavenge and vent lines, and if installed,
removal or modification of those electrical bonding jumpers and
brackets. These documents are distinct because they apply to different
airplane configurations.
    De Havilland Aircraft of Canada Limited has also issued the
following Bombardier service information, which describes fuel system
limitations, critical design configuration control limitations
(CDCCLs), or airworthiness limitations for fuel tank systems. These
documents are distinct because they

apply to different airplane configurations.
     (Bombardier) Q400 Dash 8 Aircraft Maintenance Manual (AMM)
Temporary Revision (TR) 28-170, dated November 2, 2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-171, dated November 2,
2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-166, dated November 2,
2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-167, dated November 2,
2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-168, dated November 2,
2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-169 dated November 2,
2018.
     (Bombardier) Q400 Dash 8 AMM TR 28-163, dated August 1,
2018.
     (Bombardier) Q400 Dash 8 Maintenance Task Card Manual
(MTCM) Maintenance Task Card 000-28-520-704 (Config A01), Detailed
Inspection of the Teflon Sleeve on the Fuel Tank Vent Line (LH),
Revision 43, Amendment 0001, dated August 1, 2018.
     (Bombardier) Q400 Dash 8 MTCM Maintenance Task Card 000-
28-620-704 (Config A01), Detailed Inspection of the Teflon Sleeve on
the Fuel Tank Vent Line (RH), Revision 43, Amendment 0001, dated August
1, 2018.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD will affect 53 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                   Parts cost         Cost per product         Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 94 work-hours x $85 per hour = Up               $0  Up to $7,990..............  Up to $423,470.
 to $7,990.
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                 Estimated Costs of On-Condition Actions
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          Labor cost             Parts cost         Cost per product
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Up to 40 work-hours x $85 per            $100  Up to $3,500.
 hour = Up to $3,400.
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    The FAA has received no definitive data on which to base the cost
estimates for the on-condition rework specified in this AD.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2023-01-09 De Havilland Aircraft of Canada Limited (Type Certificate
Previously Held by Bombardier, Inc.): Amendment 39-22303; Docket No.
FAA-2022-1151; Project Identifier MCAI-2020-01603-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 13, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to De Havilland Aircraft of Canada Limited (Type
Certificate previously held by Bombardier, Inc.) Model DHC-8-400, -
401, and -402 airplanes, certificated in any category, having serial
numbers 4001, 4003, and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 28, Fuel System.

(e) Unsafe Condition

    This AD was prompted by a report that electrical bonding jumpers
had been installed on fuel scavenge lines even after the removal was
required by previous AD rulemaking and electrical bonding jumpers
may have been installed in production or in service at other
locations. The FAA is issuing this AD to address altered electrical
bonding paths, which may lead to lightning strike-induced ignition
of the fuel tank.

(f) Compliance

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

(g) Definition

    For the purposes of this AD, ``prohibited tasks'' are identified
as any task identified in paragraph (j) of this AD and any procedure

or task that specifies fuel tank access using non-manufacturer-
approved procedures.

(h) Inspection and Modification

    (1) For airplanes having serial numbers 4001, and 4003 through
4118 inclusive: Within 6,000 flight hours or 36 months after the
effective date of this AD, whichever occurs first, inspect wing
stations 79.7, 136.3, 173.2, and
299.019 in the left and right wings for the presence of
brackets and electrical bonding jumpers installed on the fuel
scavenge and vent lines, in accordance with paragraph 3.B.,
``Procedure,'' of the Accomplishment Instructions of Bombardier
Service Bulletin 84-28-29, dated October 17, 2018. If installed,
remove or modify the electrical bonding jumpers and brackets as
applicable, before further flight, in accordance with paragraph
3.B., ``Procedure,'' of the Accomplishment Instructions of
Bombardier Service Bulletin 84-28-29, dated October 17, 2018.
    (2) For airplanes having serial numbers 4119 through 4597
inclusive: Within 6,000 flight hours or 36 months after the
effective date of this AD, whichever occurs first, inspect wing
stations 79.7, 136.3, and 173.2
in the left and right wings for the presence of brackets and
electrical bonding jumpers on the fuel scavenge and vent lines, in
accordance with paragraph 3.B., ``Procedure,'' of the Accomplishment
Instructions of Bombardier Service Bulletin 84-28-30, dated October
17, 2018. If installed, remove or modify the electrical bonding
jumpers and brackets as applicable, before further flight, in
accordance with paragraph 3.B., ``Procedure,'' of the Accomplishment
Instructions of Bombardier Service Bulletin 84-28-30, dated October
17, 2018.

(i) Verification and Rework for the Existing Maintenance Program

    (1) For airplanes having serial numbers 4001, and 4003 through
4597 inclusive, on which the actions required by paragraph (h)(1) or
(2) of this AD have been done before the effective date of this AD:
Within 60 days after the effective date of this AD, review the
airplane maintenance records to confirm if any of the prohibited
tasks (defined in paragraph (g) of this AD) were accomplished during
or after compliance with paragraph (h)(1) or (2) of this AD. If any
of the prohibited tasks were accomplished during or after compliance
with paragraph (h)(1) or (2) of this AD, or if it cannot be
conclusively confirmed that they were not accomplished during or
after compliance with paragraph (h)(1) or (2) of this AD: Within
6,000 flight hours or 36 months after the effective date of this AD,
whichever occurs first, do the actions required by paragraph (h)(1)
or (2) of this AD, as applicable.
    (2) For airplanes having serial numbers 4598 and subsequent,
with an airplane date of manufacture, as identified on the
identification plate of the airplane, dated before the effective
date of this AD: Within 60 days after the effective date of this AD,
review the airplane maintenance records to confirm if any of the
prohibited tasks (defined in paragraph (g) of this AD) were
accomplished on or after the airplane date of manufacture. If any of
the prohibited tasks were accomplished on or after the airplane date
of manufacture, or if it cannot be conclusively confirmed that they
were not accomplished on or after the airplane date of manufacture:
Within 6,000 flight hours or 36 months after the effective date of
this AD, whichever occurs first, obtain and follow instructions for
rework using a method approved by the Manager, New York ACO Branch,
FAA; or Transport Canada; or De Havilland Aircraft of Canada
Limited's Transport Canada Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(j) Maintenance Task Prohibitions

    For all airplanes: As of the effective date of this AD, comply
with the prohibitions specified in paragraphs (j)(1) and (2) of this
AD.
    (1) It is prohibited to use the Bombardier aircraft maintenance
manual (AMM) tasks identified in paragraphs (j)(1)(i) through (vii)
of this AD, which are specified in the Bombardier Q400, PSM 1-84-2,
Revision 63, dated October 5, 2018, or earlier revisions of these
tasks. Temporary Revisions (TRs) including these AMM tasks, dated
November 2, 2018, or earlier, are also prohibited for use except as
specified in paragraph (j)(1)(i) through (vii) of this AD.
    (i) Task 28-12-01-000-801, Removal of the Inboard Vent Line,
with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-170, dated
November 2, 2018.
    (ii) Task 28-12-01-400-801, Installation of the Inboard Vent
Line, with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-171,
dated November 2, 2018.
    (iii) Task 28-11-06-000-801, Removal of the Motive Flow Lines,
with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-166, dated
November 2, 2018.
    (iv) Task 28-11-06-400-801, Installation of the Motive Flow
Lines, with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-167,
dated November 2, 2018.
    (v) Task 28-11-16-000-801, Removal of the Scavenge Flow Lines,
with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-168, dated
November 2, 2018.
    (vi) Task 28-11-16-400-801, Installation of the Scavenge Flow
Lines, with the exception of (Bombardier) Q400 Dash 8 AMM TR 28-169,
dated November 2, 2018.
    (vii) Task 28-10-00-280-806, Detailed Inspection of the Teflon
Sleeve on the Fuel Tank Vent Line, LH and RH (FSL #284000-406), with
the exception of (Bombardier) Q400 Dash 8 AMM TR 28-163, dated
August 1, 2018.
    (2) It is prohibited to use the Bombardier Q400 Dash 8
Maintenance Task Card Manual (MTCM) task cards identified in
paragraphs (j)(2)(i) and (ii) of this AD that are specified in the
Bombardier Q400 Dash 8 MTCM, PSM 1-84-7TC, Revision 43, dated May 5,
2018, or earlier revisions or amendments of these task cards. MTCM
task card revisions or amendments dated August 1, 2018, or earlier,
are also prohibited for use, except as specified in paragraphs
(j)(2)(i) and (ii) of this AD.
    (i) Bombardier Q400 Dash 8 MTCM Maintenance Task Card 000-28-
520-704 (Config A01), Detailed Inspection of the Teflon Sleeve on
the Fuel Tank Vent Line (LH), with the exception of (Bombardier)
Q400 Dash 8 MTCM Maintenance Task Card 000-28-520-704 (Config A01),
Detailed Inspection of the Teflon Sleeve on the Fuel Tank Vent Line
(LH), Revision 43, Amendment 0001, dated August 1, 2018.
    (ii) Bombardier Q400 Dash 8 MTCM Maintenance Task Card 000-28-
620-704 (Config A01), Detailed Inspection of the Teflon Sleeve on
the Fuel Tank Vent Line (RH), with the exception of (Bombardier)
Q400 Dash 8 MTCM Maintenance Task Card 000-28-620-704 (Config A01),
Detailed Inspection of the Teflon Sleeve on the Fuel Tank Vent Line
(RH), Revision 43, Amendment 0001, dated August 1, 2018.

(k) Other AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the responsible Flight
Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada; or De Havilland Aircraft of Canada
Limited's Transport Canada DAO. If approved by the DAO, the approval
must include the DAO-authorized signature.

(l) Additional Information

    (1) Refer to Transport Canada AD CF-2020-01, dated January 14,
2020, for related information. This Transport Canada AD may be found
in the AD docket at regulations.gov under Docket No. FAA-2022-1151.
    (2) For more information about this AD, contact Joseph
Catanzaro, Aerospace Engineer, Airframe and Propulsion Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) (Bombardier) Q400 Dash 8 Aircraft Maintenance Manual (AMM)
Temporary

Revision (TR) 28-170, dated November 2, 2018.
    (ii) (Bombardier) Q400 Dash 8 AMM TR 28-171, dated November 2,
2018.
    (iii) (Bombardier) Q400 Dash 8 AMM TR 28-166, dated November 2,
2018.
    (iv) (Bombardier) Q400 Dash 8 AMM TR 28-167, dated November 2,
2018.
    (v) (Bombardier) Q400 Dash 8 AMM TR 28-168, dated November 2,
2018.
    (vi) (Bombardier) Q400 Dash 8 AMM TR 28-169 dated November 2,
2018.
    (vii) (Bombardier) Q400 Dash 8 AMM TR 28-163, dated August 1,
2018.
    (viii) (Bombardier) Q400 Dash 8 Maintenance Task Card Manual
(MTCM) Maintenance Task Card 000-28-520-704 (Config A01), Detailed
Inspection of the Teflon Sleeve on the Fuel Tank Vent Line (LH),
Revision 43, Amendment 0001, dated August 1, 2018.
    (ix) (Bombardier) Q400 Dash 8 MTCM Maintenance Task Card 000-28-
620-704 (Config A01), Detailed Inspection of the Teflon Sleeve on
the Fuel Tank Vent Line (RH), Revision 43, Amendment 0001, dated
August 1, 2018.
    (x) Bombardier Service Bulletin 84-28-29, dated October 17,
2018.
    (xi) Bombardier Service Bulletin 84-28-30, dated October 17,
2018.
    (3) For service information identified in this AD, contact De
Havilland Aircraft of Canada Limited, Dash 8 Series Customer
Response Centre, 5800 Explorer Drive, Mississauga, Ontario, L4W 5K9,
Canada; telephone North America (toll-free):<PHONE_NUMBER>, Direct:
647-277-5820; email dehavilland.com">[email protected]dehavilland.com; website dehavilland.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 10, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-02370 Filed 2-3-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 15, 2008 (Volume 73, Number 73)]
[Rules and Regulations]
[Page 20175-20177]
[DOCID:fr15ap08-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2007-1139; FRL-8554-6 ]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Control of Volatile Organic Compound (VOCs) Emissions From
the Kraft Foods Global, Inc.--Bakery Located in Henrico County, VA

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Virginia. This revision pertains to a
federally enforceable State operating permit containing terms and
conditions for the control of emissions of volatile organic compounds
(VOCs) from the Kraft Foods Global, Inc.--Richmond Bakery located in
Henrico County, Virginia. The submittal is for the purpose of meeting
the requirements for reasonably available control technology (RACT) in
order to implement the maintenance plan for the Richmond 8-hour ozone
maintenance area. EPA is approving the revision to the Virginia SIP in
accordance with the requirements of the Clean Air Act (CAA).

DATES: Effective Date: This final rule is effective on May 15, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-1139. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and 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 through
www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650 Arch Street, Philadelphia,
Pennsylvania 19103. Copies of the State submittal are available at the
Virginia Department of Environmental Quality, 629 East Main Street,
Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On January 31, 2008 (73 FR 5781), EPA published a notice of
proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR
proposed approval of Virginia's SIP revision for the purpose of meeting
RACT requirements in order to implement the maintenance plan for the
Richmond 8-hour ozone maintenance area. The formal SIP revision was
submitted by the Virginia Department of Environmental Quality on
October 29, 2007. Other specific requirements of RACT and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. No comments were received on the NPR.

II. Summary of SIP Revision

    The Virginia Department of Environmental Quality is requesting that
a revision to the Commonwealth's SIP concerning a federally enforceable
State operating permit containing terms and conditions for the control
of emissions of VOCs from the Kraft Foods Global, Inc.--Richmond Bakery
located in Henrico County, Virginia be approved. The purpose of this
revision is for meeting the requirements for RACT in order to implement
the maintenance plan for the Richmond 8-hour ozone maintenance area.

III. General Information Pertaining to SIP Submittals From the
Commonwealth of Virgina

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) that are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts. * * *'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the

extent consistent with requirements imposed by Federal law,'' any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or
civil penalty. The Attorney General's January 12, 1998 opinion states
that the quoted language renders this statute inapplicable to
enforcement of any Federally authorized programs, since ``no immunity
could be afforded from administrative, civil, or criminal penalties
because granting such immunity would not be consistent with Federal
law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the Clean Air Act is likewise
unaffected by this, or any, state audit privilege or immunity law.
    Other specific requirements of the SIP revision and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. No public comments were received on the NPR.

IV. Final Action

    Virginia has met the requirements concerning a federally
enforceable State operating permit containing terms and conditions for
the control of emissions of VOCs from the Kraft Foods Global, Inc.--
Richmond Bakery located in Henrico County, Virginia, and EPA is
therefore approving Virginia's revision for the purpose of this
revision is for meeting the requirements for RACT in order to implement
the maintenance plan for the Richmond 8-hour ozone maintenance area.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804, however, exempts from section 801 the
following types of rules: rules of particular applicability; rules
relating to agency management or personnel; and rules of agency
organization, procedure, or practice that do not substantially affect
the rights or obligations of non-agency parties. 5 U.S.C. 804(3).
Because this is a rule of particular applicability, EPA is not required
to submit a rule report regarding this action under section 801.

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 16, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action.
    This action approving Virginia's SIP revision pertaining to a
federally enforceable State operating permit containing terms and
conditions for the control of emissions of volatile organic compounds
(VOCs) from the Kraft Foods Global, Inc.--Richmond Bakery located in
Henrico County, Virginia may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

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

    Dated: April 3, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

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

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (d) is amended by adding
the entry for Kraft Food Global, Inc.--Richmond Bakery at the end of
the table to read as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (d) * * *

                                    EPA-Approved Source-Specific Requirements
----------------------------------------------------------------------------------------------------------------
                                   Permit/order or      State effective                          40 CFR part 52
          Source name            registration number         date          EPA approval date        citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Kraft Foods Global, Inc.--      Registration No.                9/19/07  4/15/08 [Insert page      52.2420(d)(8)
 Richmond Bakery.                50703.                                   number where the
                                                                          document begins].
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-7876 Filed 4-14-08; 8:45 am]

BILLING CODE 6560-50-P


Roberts, and Sherman), Virginia (only the counties of Dinwiddie,
Franklin City, Greensville, Isle of Wight, Northampton, Southampton,
Suffolk City, Surrey, Sussex), and Missouri (only the counties of
Dunkin, New Madrid, Pemiscot, Scott, Stoddard).

Stewardship (Resistance Monitoring, Remedial Action, Compliance
Assurance)

Syngenta did not address resistance monitoring, remedial action, and
refuge compliance for the 5307 pyramids other than to indicate that
existing programs would be utilized for the new products.

The existing stewardship framework developed for the lepidopteran toxins
(Cry1Ab, Cry1F, and Vip3Aa20) has been coordinated by the Agricultural
Biotechnology Stewardship Technical Committee (ABSTC) for over a decade.
 BPPD agrees that no additional information is needed for the inclusion
of the 5307 products into the ABSTC programs for resistance monitoring,
remedial action, and compliance assurance.

Corn rootworm resistance monitoring has not been implemented by ABSTC
and each registrant has developed a toxin-specific plan (though there
are common structural elements between plans).  Syngenta’s CRW
monitoring and remedial action plans were developed for the MIR604
product registrations (67979-5, -8; amended September, 2010).  The
general structure should be applicable to the 5307 registrations,
however, additional information is recommended for the eCry3.1Ab toxin.
Baseline susceptibility data for eCry3.1Ab were not addressed or
submitted with the IRM volume.  Also, a proposal for a diagnostic assay
(to distinguish potentially resistant rootworm from susceptibles) was
not included in the submission.  BPPD recommends that Syngenta develop
both baseline susceptibility data and a (plant-based) diagnostic assay
for eCry3.1Ab as a term or condition of registration.

Resistance monitoring for CRW has been challenged by the “non-high
dose” nature of the Bt toxins.  CRW do not adapt well to artificial
diets and monitoring assays based on toxin-diet incorporation have been
variable and may be unreliable for detecting shifts in susceptibility.
  As part of the 2010 extensions of Bt corn registrations, BPPD notes
that Syngenta was required to pursue the use of the “Sublethal
Seedling Assay” (Nowatzki et al. 2008) as a potential diagnostic assay
for mCry3A.  This technique involves assessing the rate of larval
development on corn seedlings and was shown to be more sensitive to
changes in susceptibility to Cry34/35 (a separately registered CRW
toxin).  It is recommended that Syngenta also investigate the
feasibility of this approach for eCry3.1Ab.  In addition to the
Sublethal Seedling Assay, the 2010 extension of mCry3A required Syngenta
to:  1) develop a resistance monitoring plan for northern corn rootworm
(Diabrotica barberi) and 2) establish corn rootworm damage guidelines
(for unexpected pest damage investigations).  BPPD recommends that these
requirements also be applied to the eCry3.1Ab registrations.

Syngenta’s submission indicated that they plan to submit the usual
annual reports required for Bt corn (i.e., resistance monitoring,
compliance, and sales) for the 5307 products.  BPPD notes that
Syngenta’s grower education materials (e.g., technology use guides)
will need to be updated to include the 5307 product line and refuge
requirements.  BPPD recommends that these materials be submitted to the
Agency prior to or concurrent with the first commercial growing season
of the products.

References

Anilkumar, K.J., A. Rodrigo-Simón, J. Ferré, M. Pusztai-Carey, S.
Sivasupramaniam, and W. J. Moar, 2008.  Production and Characterization
of Bacillus thuringiensis Cry1Ac-Resistant Cotton Bollworm Helicoverpa
zea (Boddie).  Appl. Environ. Microbiol.  74:  462-469.

BPPD, 2001.  Biopesticide Registration Action Document (BRAD):  Cry1Ab
and Cry1F Bacillus thuringiensis (Bt) Corn Plant Incorporated
Protectants (updated September, 2010).  Available at
http://www.epa.gov/oppbppd1/biopesticides/pips/cry1f-cry1ab-brad.pdf

BPPD, 2005.  Bacillus thuringiensis Cry34Ab1 and Cry35Ab1 Proteins and
the Genetic Material Necessary for their Production in Event DAS-59122-7
Corn Biopesticide Registration Action Document (BRAD).   Available at
HYPERLINK
"http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_00
6490.pdf"
http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_006
490.pdf .

BPPD, 2006.  Biopesticide Registration Action Document (BRAD):  Modified
Cry3A Protein and the Genetic Material Necessary for its Production (via
elements of pZM26) in Event MIR604 Corn SYN-IR604-8 (updated September,
2010).   Available at
http://www.epa.gov/oppbppd1/biopesticides/pips/mcry3a-brad.pdf.

BPPD, 2008.  Biopesticide Registration Action Document (BRAD):  Bacillus
thuringiensis Cry1A.105 and Cry2Ab2 Insecticidal Proteins and the
Genetic Material Necessary for Its Production in Corn (updated
September, 2010).  Available at   HYPERLINK
"http://www.epa.gov/oppbppd1/biopesticides/pips/mon-89034-brad.pdf"
http://www.epa.gov/oppbppd1/biopesticides/pips/mon-89034-brad.pdf

BPPD, 2009a.  Biopesticide Registration Action Document (BRAD):
Bacillus thuringiensis Vip3Aa20 Insecticidal Protein and the Genetic
Material Necessary for Its Production (via Elements of Vector pNOV1300)
in Event MIR162 Maize (OECD Unique Identifier: SYN-IR162-4) (updated
March, 2009).  Available at   HYPERLINK
"http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_00
6599.pdf"
http://www.epa.gov/oppbppd1/biopesticides/ingredients/tech_docs/brad_006
599.pdf

BPPD, 2009b.  Review of Additional Insect Resistance Management (IRM)
information for SmartStax (MON 89034 x TC1507 x MON 88017 x DAS 59122-7)
Bt corn.  A. Reynolds memorandum to M. Mendelsohn, dated July 1, 2009.

BPPD, 2010a. Science Assessment of Pioneer’s modeling addenda (MRIDs
478710-01, 478879-01, and 479108-01) in support of their application of
registration for Optimum AcreMax1 Insect Protection.  J. Martinez
memorandum to M. Mendelsohn, dated February 4, 2010.

BPPD, 2010b.  Review of Insect Resistance Management (IRM)
considerations with a proposed reduced refuge for Bt corn event 1507 x
MON 810 in the Corn Belt.  A. Reynolds memorandum to A. Sibold, dated
October 20, 2010.

BPPD, 2010c.  EPA PRELIMINARY RISK ASSESSMENT of Monsanto’s and
Dow’s 5% Seed Mixture Request for a Section (3) Full Commercial
Registration of SmartStax Corn.  J. Martinez memorandum to M.
Mendelsohn, dated October 29, 2010.

BPPD, 2011.  Review of the Insect Resistance Management (IRM) plan and
supporting data for Bt corn event Bt11 x MIR162 x TC1507.  A. Reynolds
memorandum to J. Kausch, dated March 2, 2011.

Caprio, M., 1998. Evaluating resistance management strategies for
multiple toxins in the presence of external refuges.  J. Econ. Entomol.
91: 1021-1031.

Caprio, MA and JA Glaser. 2010. “Simulation model evaluation of pest
resistance development to refuge in the bag concepts related to Pioneer
Submission”. Report generated for OPP/BPPD on January 22, 2010.

Denholf, P., S. Jansens, M. Peferoen, D. Degheele, and J. Van Rie, 1993.
 Two different

Bacillus thuringiensis delta-endotoxin receptors in the midgut brush
border membrane of the European Corn Borer, Ostrinia nubilalis (Hübner)
(Lepidoptera: Pyralidae).  Appl. Environ. Microbiol.  59: 1828-1837.

Ferré, J., M. D. Read, J. Van Rie, S. Jansens, and M. Peferoen, 1991.
Resistance to the Bacillus

thuringiensis bioinsecticide in a field population of Plutella
xylostella is due to a change in a midgut membrane receptor.  Proc.
Natl. Acad. Sci. USA.  88: 5119-5123.

Ferré, J. and J. Van Rie, 2002.  Biochemistry and genetics of insect
resistance to Bacillus thuringiensis.  Annu. Rev. Entomol.  47:
501-533.

Gassmann, A.J., J.L. Petzold-Maxwell, R.S. Keweshan, and M.W. Dunbar,
2011.  Field-evolved resistance to Bt maize by western corn rootworm.
PLoS ONE.  6(7): 1-7.

Gould, F., A. Anderson, A. Reynolds, L. Bumgarner, and W. Moar, 1995.
Selection and genetic analysis of a Heliothis virescens (Lepidoptera:
Noctuidae) strain with high levels of resistance to Bacillus
thuringiensis toxins.  J. Econ. Entomol. 88: 1545-59.

Gould, F., M. B. Cohen, J. S. Bentur, G. C. Kennedy, and J. Van Duyn,
2006. Impact of small fitness costs on pest adaptation to crop varieties
with multiple toxins: a heuristic model.  J. Econ. Entomol. 99:
2091-2099.

Granero, F., V. Ballester, and J. Ferre, 1996.  Bacillus thuringiensis
crystal proteins CRY1Ab and CRY1Fa share a high affinity binding site in
Plutella xylostella (L.).  Biochem. Biophys. Res. Comm.  224: 779-783.

Hibbard B.E., L.N. Meihls, M.R. Ellersieck, and D.W. Onstad, 2010a.
Density-dependent and density-independent mortality of the Western corn
rootworm: impact on dose calculations of rootworm-resistant Bt corn. J.
Econ. Entomol.  103: 77-84.

Hibbard, B.E., T.L. Clark, M.R. Ellersieck, L.N. Meihls, A.A. El
Khishen, V. Kaster, H. York-Steiner, and R. Kurtz, 2010b. Mortality of
western corn rootworm larvae on MIR604 transgenic maize roots: Field
survivorship has no significant impact on survivorship of F1 progeny on
MIR604. J. Econ. Entomol.  103: 2187-2196.

Hua, G., L. Masson, J.L. Jurat-Fuentes, G. Schwab, and M.J. Adang, 2001.
Binding Analyses of Bacillus thuringiensis Cry {delta}-Endotoxins Using
Brush Border Membrane Vesicles of Ostrinia nubilalis.  Appl. Environ.
Microbiol.  67: 872-879.

Lee, M.K., F. Rajamohan, F. Gould, and D.H. Dean, 1995.  Resistance to
Bacillus thuringiensis Cry1A δ-endotoxins in a laboratory-selected
Heliothis virescens strain is related to receptor alteration.  Appl.
Environ. Microbiol.  61:  3836-3842.

Lefko, S.A., T.M. Nowatzki, S.D. Thomposon, R.R. Binning, M.A. Pascual,
M.L. Peters, E.J. Simbro, and B.F. Stanley, 2008. Characterizing
laboratory colonies of western corn rootworm (Coleoptera: Chrysomelidae)
selected for survival on maize containing event DAS-59122.  J. Appl.
Entomol.  132: 189-204

Meihls L.N., M.L. Higdon, B.D. Siegfried, T.A. Spencer, N.J. Miller,
T.W. Sappington, M.R. Ellersieck, and B.E. Hibbard, 2008.  Increased
survival of western corn rootworm on transgenic corn within three
generations of on-plant greenhouse selection.  Proceed. Nat. Acad. Sci.
105: 19177-19182.

Meihls L.N., M.L. Higdon, M.R. Ellersieck, and B.E. Hibbard, 2011.
Selection for resistance to mCry3A-expressing transgenic corn in western
corn rootworm.  J. Econ. Entomol.  104: 1045-1054.

Nowatzki, T.M., S.A. Lefko, R.R. Binning, S.D. Thompson, T.A. Spencer,
and B.D. Siegfried, 2008.  Validation of a novel resistance monitoring
technique for corn rootworm (Coleoptera: Chrysomelida) and event
DAS-59122-7 maize.  J. Appl. Entomol. 132: 177-188.

Onstad, D. and L. Meinke, 2010.  Modeling Evolution of Diabrotica
virgifera virgifera (Coleoptera: Chrysomelidae) to Transgenic Corn with
Two Insecticidal Traits.  J. Econ Entomol.  103: 849-860.

Pereira E.J., H.A. Siqueira, M. Zhuang, N.P. Storer, B.D. Siegfried,
2010.  Measurements of Cry1F binding and activity of luminal gut
proteases in susceptible and Cry1F resistant Ostrinia nubilalis larvae
(Lepidoptera: Crambidae).  J. Invertebr. Pathol. 103: 1-7.

Roush, R.T., 1998.  Two toxin strategies for management of insecticidal
transgenic crops:  will pyramiding succeed where pesticide mixtures have
not?  Phil. Trans. R. Soc. Lond. 353:  1777-1786.

Scientific Advisory Panel (SAP), 1998.  Transmittal of the final report
of the FIFRA Scientific Advisory Panel Subpanel on Bacillus
thuringiensis (Bt) Plant-Pesticides and Resistance Management, Meeting
held on February 9-10, 1998.   Report dated, April 28, 1998.  (Docket
Number:  OPPTS-00231).

Scientific Advisory Panel (SAP), 2011.  Transmittal of the meeting
minutes of the FIFRA Scientific Advisory meeting held on December 8-9,
2011 to address scientific issues associated with insect resistance
management for SmartStax refuge-in-a-bag, a plant-incorporated
protectant (PIP) corn seed blend.  Report dated, March 3, 2011.  (Docket
Number:  EPA-HQ-OPP-2010-0772).

Siqueira, H.A.A., D. Moellenbeck, T. Spencer, and B.D. Siegfried, 2004.
Cross-resistance of CrylAb-selected Ostrinia nubilalis (Lepidoptera:
Crambidae) to Bacillus thuringiensis d-endotoxins.  J. Econ. Entomol.
97: 1049-1057.

Storer, N., 2002.  Product durability plan for cotton expressing Cry1F
and Cry1Ac insecticidal crystal proteins from Bacillus thuringiensis.
Unpublished report submitted to EPA by Dow Agrosciences.  MRID#
458084-15.

Storer, N., 2003.  A spatially explicit model simulation western corn
rootworm (Coleoptera:  Chrysomelidae) adaptation to insect-resistance
maize.  J. Econ. Entomol.  96:  1530-1547.

Storer, N., J.M. Babcock, and J.M. Edwards, 2006.  Field measures of
western corn rootworm (Coleoptera:  Chrysomelidae) mortality caused by
Cry34/35Ab1 proteins expressed in maize event 59122 and implications for
trait durability.  J. Econ. Entomol.  99:  1381-1387.

Tabashnik, B. E., 1994.  Evolution of resistance to Bacillus
thuringiensis.  Annu. Rev. Entomol.  39: 47-79.

Walters, F., C. deFontes, H. Hart, G. Warren, and J. Chen, 2010.
Lepidopteran-active variable-region sequence imparts coleopteran
activity in eCry3.1Ab, an engineered Bacillus thuringiensis hybrid
insecticidal protein.  Appl. Environ. Microbiol.  76:  3082-3088.

Zhao, J., J. Cao, Y. Li, H. Collins, R. Roush, E. Earle, and A. Shelton,
2003. Transgenic plants expressing two Bacillus thuringiensis toxins
delay insect resistance evolution.  Nature Biotechnology.  21:
1493-1497.

G. 	Benefits and Public Interest Finding for Initial Registrations of
Event 5307  Corn

The criteria for determining whether registration of a pesticide
chemical is in the public interest are set forth in a Federal Register
Notice dated March 5, 1986 volume 51, No. 43 (OPP-32500; FRL-2977-2)
titled Conditional Registration of New Pesticides. There is a
presumption that registration of a pesticide chemical is in the public
interest if one of the following criteria is met: i) the use is for a
minor crop; (ii) the use is a replacement for another pesticide that is
of continuing concern to the Agency; (iii) the use is one for which an
emergency exemption under FIFRA Section 18 has been granted for lack of
an alternative pest control method, or (iv) the use is against a pest of
public health significance. Further, EPA may determine that such a
registration is in the public interest on the basis of the following
criteria: i) there is a need for the new chemical that is not being met
by currently registered pesticides; ii) the new pesticide is
comparatively less risky to health or the environment than currently
registered pesticides; or iii) the benefits (including economic
benefits) from the use of the new active ingredient exceed those of
alternative registered pesticides and other available nonchemical
techniques.

Syngenta has provided data to support its claim that 5307 CRW-protected
corn is in the public interest (MRID# 484425-41). EPA’s analysis
supports the following conclusions:

1. Results of efficacy trials conducted from 2006 to 2009 indicate that
5307 corn

provides effective control of key rootworm pests of field corn,
including western corn rootworm (Diabrotica virgifera virgifera),
northern corn rootoworm (Diabrotica barberi), and Mexican corn rootworm
(Diabrotica virgifera zeae).  Efficacy was measured in terms of root
damage (i.e., crop protection) and adult emergence (i.e., population
reduction).

2. The eCry3.1Ab protein expressed in 5307 is a novel mode of action for
corn rootworm control.  The protein is a chimera engineered from the
mCry3A and Cry1Ab Bt proteins.  It has unique biochemical properties and
low cross resistance potential with other registered Bt PIPs targeting
CRW (refer to the Insect Resistance Management chapter in this BRAD
document).  As such, 5307 is expected to provide insect resistance
management (IRM) benefits for this and other CRW-protected corn products
(detailed in #3 below).

3. CRW is a highly adaptive insect and has been able to overcome a
number of cultural and chemical control regimes (Meinke et al. 1998,
Spencer et al. 2005).  Recent reports have suggested that CRW may be
developing resistance to Cry3Bb1, a separately-registered Bt toxin
(Gassmann et al. 2011, Gassmann 2012).  Bt toxins for CRW control may
have a higher risk of resistance than other PIPs because they are not
expressed at “high dose” levels for the insect (Tabashnik and Gould
2012).  On the other hand, the availability of multiple toxins for CRW
with unique modes of action (i.e., a toxin mosaic) may enhance IRM by
reducing the selection pressure on any one toxin.  The 5307 (eCry3.1Ab)
protein would represent the fourth Bt toxin for CRW and would further
expand the existing toxin mosaic.  Furthermore, it is expected that 5307
will be included with other Bt proteins to provide multiple control
mechanisms in a single product (known as a toxin “pyramid”).
Simulation models predict that toxin pyramids with unique modes of
action are more durable (less susceptible to resistance) than single
toxin PIPs (Roush 1998, Zhao et al. 2003, Onstad et al. 2010).
Syngenta has proposed two such pyramids with 5307 and a second CRW
toxin, MIR604 (mCry3A):  a) Bt11 x MIR604 x TC1507 x 5307 and b) Bt11 x
MIR162 x MIR604 x TC1507 x 5307.

4. If 5307 corn is registered, it will be the fourth CRW-protected Bt
corn product on the market.

The availability of multiple CRW-protected corn products will increase
grower choice and price competition, likely resulting in lower seed
prices for consumers and higher adoption rates.

5.  Data provided by Syngenta from a three-year study showed that 5307
corn provided significantly greater crop yield (bushels/acre) than
non-Bt corn with or without insecticide use.  Syngenta reported a yield
benefit of 63 bushels/acre compared to non-Bt corn without insecticide
and 25 bushels/acre relative to non-Bt corn treated with Force 3G
insecticide.  Yield from 5307 was comparable (statistically equivalent)
to MIR604 corn (a separate CRW-protected PIP registered by Syngenta).

6. Registration of 5307 corn is expected to result in further reduction
of chemical insecticide use by growers. This is of special importance
since many pesticides registered for CRW-control are highly toxic to
humans and the environment, while eCry3.1Ab-expressing corn poses no
foreseeable human health or environmental risks (refer to the Human
Health Assessment and Environmental Assessment chapters in this BRAD
document).  Syngenta’s submission provided a summary of the
conventional insecticides used for CRW control; many of these products
are “restricted use” due to high mammalian toxicity and bear
environmental hazards statements warning of dangers to birds, mammals,
fish, aquatic invertebrates, and bees. EPA previously conducted an
assessment of these insecticides and their associated mammalian and
environmental toxicities for Cry3Bb1, a previously-registered CRW PIP
(see U.S. EPA 2010).  This analysis also demonstrated the high toxicity
and environmental concerns of many CRW insecticides used in field corn.

REFERENCES

Gassmann A.J., J.L. Petzold-Maxwell, R.S. Keweshan, and M.W. Dunbar,
2011. Field-evolved resistance to Bt maize by western corn rootworm.
PLOS one, Vol. 6 (7): 1-7.

Gassmann, A.J., 2012.  Field-evolved resistance to Bt maize by western
corn rootworm:  Predictions from the laboratory and effects in the
field.  J. Invertebr. Pathol.  In press.

Meinke, L.J., B.D. Siegfried, R.J. Wright, and L.D. Chandler, 1998.
Adult susceptibility of Nebraska western corn rootworm (Coleoptera:
Chrysomelidae) populations to selected insecticides.  J. Econ Entomol.
91: 594-600.

Onstad, D. and L. Meinke, 2010.  Modeling Evolution of Diabrotica
virgifera virgifera (Coleoptera: Chrysomelidae) to Transgenic Corn with
Two Insecticidal Traits.  J. Econ Entomol.  103: 849-860.

Roush, R.T., 1998.  Two toxin strategies for management of insecticidal
transgenic crops:  will pyramiding succeed where pesticide mixtures have
not?  Phil. Trans. R. Soc. Lond. 353:  1777-1786.

Spencer, J.L., E. Levine, S.A. Isard, and T.R. Mabry, 2005.  Movement,
dispersal and behaviour of western corn rootworm adults in rotated maize
and soybean fields.  In: Vidal, S. et al. (Eds.), Western Corn Rootworm:
 Ecology and Management, CABI Publishing, Cambridge, pp. 121-144.

Tabashnik, B.E. and F. Gould, 2012.  Delaying corn rootworm resistance
to Bt corn.  J. Econ Entomol.  105: 767-776.

U.S. EPA. 2010. Biopesticide Registration Action Document for Bacillus
thuringiensis Cry3Bb1 Protein and the Genetic Material Necessary for Its
Production (Vector PV-ZMIR13L) in MON 863 Corn (OECD Unique Identifier:
MON-ØØ863-5).  HYPERLINK
"http://www.epa.gov/oppbppd1/biopesticides/pips/cry3bb1-brad.pdf"
http://www.epa.gov/oppbppd1/biopesticides/pips/cry3bb1-brad.pdf

Zhao, J., J. Cao, Y. Li, H. Collins, R. Roush, E. Earle, and A. Shelton,
2003. Transgenic plants expressing two Bacillus thuringiensis toxins
delay insect resistance evolution.  Nature Biotechnology.  21

III.	 REGULATORY POSITION FOR EVENT 5307 CORN

Pursuant to section 3(c)(7)(C) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), the Environmental Protection Agency (EPA)
may conditionally register a new pesticide active ingredient for a
period of time reasonably sufficient for the generation and submission
of required data that are lacking because insufficient time has elapsed
since the imposition of the data requirement for those data to be
developed. EPA may grant such conditional registration only if EPA
determines that (1) the use of the pesticide product during the period
of the conditional registration will not cause any unreasonable adverse
effect on the environment, and (2) the registration and use of the
pesticide during the conditional registration is in the public interest.
EPA determines that all of these criteria have been fulfilled.

The first criterion under FIFRA section 3(c)(7)(C), as mentioned above,
has been met because insufficient time has elapsed since the imposition
of the requirements for the following data:

1) Additional data or analysis to address the cross resistance potential
of eCry3.1Ab with Cry3Bb1 and Cry35/35Ab1.  As part of this effort, BPPD
also recommends that Syngenta work to develop a eCry3.1Ab-resistant
colony (similar to the work done for mCry3A -- see Meihls et al. 2011).

2) Additional data for corn rootworm resistance monitoring with the
eCry3.1Ab toxin:

Baseline susceptibility data;

A proposal for a plant-based diagnostic assay including an investigation
into the feasibility of using the “Sublethal Seedling Assay”
(Nowatzki et al. 2008);

A monitoring plan for northern corn rootworm (Diabrotica barberi);

Corn rootworm damage guidelines (for unexpected pest damage
investigations of eCry3.1Ab corn).

The applicants submitted and/or cited data sufficient for EPA to
determine that conditional registration of the Bacillus thuringiensis
eCry3.1Ab insecticidal protein and the genetic material necessary for
its

production (via elements of vector PSYN12274) in 5307 Corn (SYN-(53(7-1)
under FIFRA section 3(c)(7)(C) will not result in unreasonable adverse
effects to the environment, as discussed above. The applicants submitted
and/or cited satisfactory data pertaining to the proposed use. The human
health effects and non-target organism effects data are considered
sufficient for the period of the conditional registration. These data
demonstrate that no foreseeable human health hazards or environmental
effects are likely to arise from the use of the products and,
furthermore, that the risk of resistance developing to the eCry3.1Ab
proteins during the conditional registrations is not expected to be
significant.

Registration of the Bacillus thuringiensis eCry3.1Ab insecticidal
protein and the genetic material necessary for its production (via
elements of vector PSYN12274) in 5307 Corn (SYN-(53(7-1)  is in the
public interest for the following reasons:

1. Results of efficacy trials conducted from 2006 to 2009 indicate that
5307 corn

provides effective control of key rootworm pests of field corn,
including western corn rootworm (Diabrotica virgifera virgifera),
northern corn rootoworm (Diabrotica barberi), and Mexican corn rootworm
(Diabrotica virgifera zeae).  Efficacy was measured in terms of root
damage (i.e., crop protection) and adult emergence (i.e., population
reduction).

2. The eCry3.1Ab protein expressed in 5307 is a novel mode of action for
corn rootworm control.  The protein is a chimera engineered from the
mCry3A and Cry1Ab Bt proteins.  It has unique biochemical properties and
low cross resistance potential with other registered Bt PIPs targeting
CRW (refer to the Insect Resistance Management chapter in this BRAD
document).  As such, 5307 is expected to provide insect resistance
management (IRM) benefits for this and other CRW-protected corn products
(detailed in #3 below).

3. CRW is a highly adaptive insect and has been able to overcome a
number of cultural and chemical control regimes (Meinke et al. 1998,
Spencer et al. 2005).  Recent reports have suggested that CRW may be
developing resistance to Cry3Bb1, a separately-registered Bt toxin
(Gassmann et al. 2011, Gassmann 2012).  Bt toxins for CRW control may
have a higher risk of resistance than other PIPs because they are not
expressed at “high dose” levels for the insect (Tabashnik and Gould
2012).  On the other hand, the availability of multiple toxins for CRW
with unique modes of action (i.e., a toxin mosaic) may enhance IRM by
reducing the selection pressure on any one toxin.  The 5307 (eCry3.1Ab)
protein would represent the fourth Bt toxin for CRW and would further
expand the existing toxin mosaic.  Furthermore, it is expected that 5307
will be included with other Bt proteins to provide multiple control
mechanisms in a single product (known as a toxin “pyramid”).
Simulation models predict that toxin pyramids with unique modes of
action are more durable (less susceptible to resistance) than single
toxin PIPs (Roush 1998, Zhao et al. 2003, Onstad et al. 2010).
Syngenta has proposed two such pyramids with 5307 and a second CRW
toxin, MIR604 (mCry3A):  a) Bt11 x MIR604 x TC1507 x 5307 and b) Bt11 x
MIR162 x MIR604 x TC1507 x 5307.

4. If 5307 corn is registered, it will be the fourth CRW-protected Bt
corn product on the market.

The availability of multiple CRW-protected corn products will increase
grower choice and price competition, likely resulting in lower seed
prices for consumers and higher adoption rates.

5.  Data provided by Syngenta from a three-year study showed that 5307
corn provided significantly greater crop yield (bushels/acre) than
non-Bt corn with or without insecticide use.  Syngenta reported a yield
benefit of 63 bushels/acre compared to non-Bt corn without insecticide
and 25 bushels/acre relative to non-Bt corn treated with Force 3G
insecticide.  Yield from 5307 was comparable (statistically equivalent)
to MIR604 corn (a separate CRW-protected PIP registered by Syngenta).

6. Registration of 5307 corn is expected to result in further reduction
of chemical insecticide use by growers. This is of special importance
since many pesticides registered for CRW-control are highly toxic to
humans and the environment, while eCry3.1Ab-expressing corn poses no
foreseeable human health or environmental risks (refer to the Human
Health Assessment and Environmental Assessment chapters in this BRAD
document).  Syngenta’s submission provided a summary of the
conventional insecticides used for CRW control; many of these products
are “restricted use” due to high mammalian toxicity and bear
environmental hazards statements warning of dangers to birds, mammals,
fish, aquatic invertebrates, and bees. EPA previously conducted an
assessment of these insecticides and their associated mammalian and
environmental toxicities for Cry3Bb1, a previously-registered CRW PIP
(see U.S. EPA 2010).  This analysis also demonstrated the high toxicity
and environmental concerns of many CRW insecticides used in field corn.

In view of these minimal risks and the clear benefits related to the
Bacillus thuringiensis eCry3.1Ab insecticidal protein and the genetic
material necessary for its production (via elements of vector PSYN12274)
in 5307 Corn (SYN-(53(7-1), EPA believes that the use of the products
during the limited period of the conditional registrations will not
cause any unreasonable adverse effects.

Although the data with respect to this particular new active ingredient
are satisfactory, they are not sufficient to support an unconditional
registration under FIFRA section 3(c)(5). Additional data are necessary
to evaluate the risk posed by the continued use of these products.
Consequently, EPA is imposing the data requirements specified earlier in
this chapter.

EPA has determined, as explained in   HYPERLINK  \l "Benefits"  section
II(G)  of this Biopesticides Registration Action Document (BRAD), that
the third criterion for a FIFRA section 3(c)(7)(C) conditional
registration has been fulfilled because use of the Bacillus
thuringiensis eCry3.1Ab insecticidal protein and the genetic material
necessary for its production (via elements of vector PSYN12274) in 5307
Corn (SYN-(53(7-1) under these registrations is in the public interest.

The submitted data, in support of these registrations under FIFRA
section 3(c)(7)(C), have been reviewed and determined to be adequate.
Studies mentioned above are included in the terms, conditions, and
limitations of these registrations. These registrations will not cause
unreasonable adverse effects to man or the environment and are in the
public interest.

The expiration date of the registrations is proposed as August 1, 2016.

C.	Period of Registration

In the 2001 Bt Corn reassessment, EPA determined that it was appropriate
to amend the then-existing registrations to extend the period of
registration of those products to an expiration date of October 15,
2008. All of the products being assessed at that time were efficacious
against lepidopteran pests. EPA based this action on the finding that
use of Cry1Ab or Cry1F expressed in corn will not significantly increase
the risk of unreasonable adverse effects on the environment “for the
limited time period of 7 additional years (to October 15, 2008).”
These registrations were later amended to extend the period of
registration to an expiration date of September 30, 2010. EPA
subsequently granted time-limited registrations to products efficacious
against coleopteran corn rootworm pests. For example, EPA registered
Cry3Bb1 on February 24, 2003, to May 1, 2004, and extended that
registration twice, to February 24, 2008, and September 30, 2010.

As set forth elsewhere in this document, EPA’s primary concern for the
Bt protected transgenic corn products is the possibility that target
pests will develop resistance to one or more of the plant-incorporated
protectant (PIP) toxins. Development of resistance to a Bt toxin would
be a grave adverse effect, and, for over 15 years, EPA has imposed
stringent requirements intended to countermand the potential development
of resistance. Registrants similarly have been busily developing various
products, product mixes (i.e., so-called “pyramids” and
“stacks”), and resistance strategies, to maximize agronomic benefits
and address resistance management issues. The result has been a vast
array of product combinations and, occurring over the past couple of
years, a re-emergence of varying refuge requirements for different
products.

As discussed in the 2001 Bt PIP BRAD (at IID13), the earliest Bt corn
registrations did not include mandatory refuge requirements. There was a
lack of scientific consensus as to what the appropriate refuge
requirement should be, and, it was assumed that the limited market
penetration of these early crops would be so low as to guarantee that
adequate natural refuges would be available from neighboring non-Bt corn
fields. From 1995 to 1997, Bt corn registrations included voluntary
refuge requirements of 0% to 20% in the Corn Belt. In 1999, the
Agricultural Biotechnology Stewardship Technical Committee (ABSTC), in
conjunction with the National Corn Growers Association, proposed uniform
insect resistance management (IRM) requirements for Bt corn
registrations. With some modifications, this proposal, put in place for
the 2000 growing season, formed the baseline IRM requirements for almost
all Bt corn registrations for the better part of a decade: farmers were
required to plant a 20% refuge that could be treated for insects, or a
50% treated refuge in cotton-growing areas; all refuges to be planted
within one-half mile of the Bt corn field.

These uniform requirements brought certainty and consistency to the
market after the initial period where many Bt corn products had
different refuge requirements. Recently, however, as product developers
have begun to conceive of products with different combinations of
“pyramided” products (i.e., products containing two or more toxins
efficacious against the same pest) and “stacked” products (i.e.,
products combining toxins efficacious against different pests), the
refuge requirements have begun to vary. For example, certain products
require a 20% external refuge; some products permit a 5% external
refuge; one product incorporates a 10% seed blend refuge; we have
applications in process for products that propose to incorporate a 5%
seed blend refuge; and other permutations are possible.

Given the profusion of various toxin combinations and refuge options, we
can no longer proceed on the basis that, as concerns insect resistance
management, all products are equal. It was a relatively simple
proposition when the default requirement of a 20% sprayed refuge applied
to almost all of the Bt corn crops in the market. Under those
circumstances, the relative durability of products against the
development of resistance was functionally equivalent, and, as a
consequence, imposing functionally equivalent registration periods was
appropriate. That is now no longer the case.

As part of our continually evolving regulatory approach to the
continually evolving product mix wrought by developers, we think it
appropriate to revise our regulatory requirements in scientifically
defensible ways to reflect the comparative level of risks posed by the
products that we regulate. Here, for example, where we’ve determined
that a particular product, or category of products, likely will pose
less risk of insect resistance developing to a particular PIP protein,
we think it appropriate to grant that particular product, or category of
products, a registration for a period greater than that granted a
corresponding product that poses a greater risk of insect resistance
developing. This approach is reflective of complementary principles:
first, to ensure that we apply our limited resources to the products
that pose greater risk of adverse effects to the environment; and,
second, to conserve the resources that registrants and applicants must
expend in amending the registrations of products that pose less risk of
adverse effects to the environment.

The scheme that we are following includes registration periods of five,
eight, and twelve years; a fifteen-year registration period will also be
available, if adequately supported by our science assessment. In this
scheme, (i) a product with a single PIP toxin, and a 20% external
refuge, qualifies for a five-year registration; (ii) a product with
pyramided PIP toxins (i.e., two or more toxins with distinct, non-cross
reacting modes of action), that are non-high dose (the definition for a
high dose product remains unchanged), with either a seed blend or
external refuge, qualifies for an eight-year registration; (iii) a
product with pyramided PIP toxins (i.e., two or more toxins with
distinct, non-cross reacting modes of action), that are high-dose, with
either a seed blend or external refuge, qualifies for a twelve-year
registration; (iv) a product with pyramided PIP toxins (i.e., two or
more toxins with distinct non-cross reacting modes of actions), with
either a seed blend or external refuge, that has been determined by
EPA’s science assessment to be 150% as durable as the baseline single
toxin product with a 20% external refuge, would qualify for a
fifteen-year registration. Products determined by EPA’s science
assessment to be less than 100% as durable as the baseline single toxin
product with a 20% external refuge would not qualify for a five-year
registration and the registration period for such products will be
determined on a case-by-case basis consistent with the level of risk
they pose. Similarly, instances where other risk issues may arise, or
where novel resistance concerns may be present, would also be determined
on a case-by-case basis, as will novel refuge configurations that may
present unique durability profiles.

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was established for mCry3A in maize [40 CFR § 174.505].

 Description of the cry1Ab gene:  The cry1Ab gene was originally cloned
from Bacillus thuringiensis var. kurstaki strain HD-1 (Geiser et al.
1986).  Its amino acid sequence has been codon-optimized (Koziel et al.
1997) to accommodate the preferred codon-usage for maize (Murray et al.
1989). The cry1Ab gene encodes for Cry1Ab protein, which is expressed in
Event Bt11 maize. Event Bt11 is currently registered for use as a PIP
(EPA Reg. No.67979-1) and its risk and benefits assessment is found in
the BRAD for the Agency’s Reassessment for Bt crops in 2001 (US EPA,
2001). An exemption from the requirement of a tolerance was established
for Cry1Ab in all crops [40 CFR § 174.511].

 Non-target invertebrate hazard tests often are conducted at exposure
concentrations several times higher than the maximum concentrations
expected to occur under realistic exposure scenarios.  This has
customarily allowed an endpoint of 50% mortality to be used as a trigger
for additional higher-tier testing.  Lower levels of mortality under
these conditions of extreme exposure suggest that population effects are
likely to be negligible given realistic exposure scenarios.  Thus, it
follows that the observed proportion of responding individuals can be
compared to a 50% effect to determine if the observed proportion is
significantly lower than 50%.  For example, using a binomial approach, a
sample size of 30 individuals is sufficient to allow a treatment effect
of 30% to be differentiated from a 50% effect with 95% confidence using
a one-sided Z test.  A one-sided test is appropriate because only
effects of less than 50% indicate that further experiments are not
needed to evaluate risk.

 OPPTS Testing Guidelines, Series 850 and 885 website:

 HYPERLINK "http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/"
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/
885Microbial_Pesticide_Test_Guidelines/Series

 The dose margin can be less than 10x where uncertainty in the system is
low or where high concentrations of test material are not possible to
achieve due to test organism feeding habits or other factors. High dose
testing also may not be necessary where many species are tested or tests
are very sensitive, although the test concentration used must exceed 1X
EEC.

 It is notable that that the 10 X EEC MHD testing approach is not
equivalent to what is commonly known as “testing at a 10X SAFETY
FACTOR” where any adverse effect is considered significant. Tier I
screen testing is not ‘safety factor testing’.  In a “10X safety
factor” test any adverse effect noted is a “level of concern”,
whereas in the EPA environmental risk assessment scenario any adverse
effect is viewed as a concern only at 1X the field exposure.

 The 1X EEC test dose is based on plant tissue content and is considered
a high worst case dose (sometimes referred to as HEEC). This 1X EEC is
still much greater than any amount which any given non-target organism
may be ingesting in the field because most non-target organisms do not
ingest plant tissue.

 The established peer and EPA Science Board reviewed guidance on
screening test levels of concern is 50% mortality at 5X environmental
concentration. The appropriate endpoints in high dose limit/screening
testing are based on mortality of the treated, as compared to the
untreated (control) non-target organisms. A single group of 30 test
animals may be tested at the maximum hazard dose.

 This research was funded by Environmental Protection Agency grant
CR-832147-01.  The Bt crop non-target effects database can be found on
the National Center for Ecological Analysis and Synthesis (NCEAS).
Website. ( HYPERLINK "http://delphi.nceas.ucsb.edu/btcrops/"
http://delphi.nceas.ucsb.edu/btcrops/ ).

 The use of BPPD in this chapter  refers to the BPPD IRM Team consisting
of Alan Reynolds and Jeannette Martinez

Bacillus thuringiensis eCry3.1Ab Corn

	Biopesticides Registration Action Document (BRAD)
         June 2012 DRAFT

Bacillus thuringiensis eCry3.!Ab Corn

	Biopesticides Registration Action Document (BRAD)
       Draft June 2012

 PAGE   2

 PAGE   3

Bacillus thuringiensis eCry3.1Ab Corn

	Biopesticides Registration Action Document (BRAD)
       Draft June 2012

Bacillus thuringiensis eCry3.1Ab Corn

	Biopesticides Registration Action Document (BRAD)
     Draft June 2012

 PAGE   4

 PAGE   5


[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38314-38315]
[FR Doc No: 2014-15762]

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

ENVIRONMENTAL PROTECTION AGENCY

 [EPA-HQ-OPPT-2013-0677; FRL-9913-01]

Receipt of Test Data Under the Toxic Substances Control Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA is announcing its receipt of test data submitted pursuant
to a test rule issued by EPA under the Toxic Substances Control Act
(TSCA). As required by TSCA, this document identifies each chemical
substance and/or mixture for which test data have been received; the
uses or intended uses of such chemical substance and/or mixture; and
describes the nature of the test data received. Each chemical substance
and/or mixture related to this announcement is identified in Unit I.
under SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Heather Njo, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW.,

Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Chemical Substances and/or Mixtures

    Information about the following chemical substances and/or mixtures
is provided in Unit IV.: 1-Decene, sulfurized (CAS No. 72162-15-3).

II. Authority

    Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a
notice in the Federal Register reporting the receipt of test data
submitted pursuant to test rules promulgated under TSCA section 4 (15
U.S.C. 2603).

III. Docket Information

    A docket, identified by the docket identification (ID) number EPA-
HQ-OPPT-2013-0677 has been established for this Federal Register
document that announces the receipt of data. The test data received
have been added to the docket for the TSCA section 4 test rule that
required the test data. Use the document ID number provided in Unit IV.
to access the test data in the docket for the related TSCA section 4
test rule.
    The docket for this Federal Register document and the docket for
each related TSCA section 4 test rule is available electronically at
http://www.regulations.gov or in person at the Office of Pollution
Prevention and Toxics Docket (OPPT Docket), Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

IV. Test Data Received

    This unit contains the information required by TSCA section 4(d)
for the test data received by EPA.
    1-Decene, sulfurized (CAS No. 72162-15-3).
    1. Chemical Use(s): Used in the petroleum and coal products
manufacturing industry as a lubricant additive.
    2. Applicable Test Rule: (HPV3), 40 CFR 799.5089.
    3. Test Data Received: The following listing describes the nature
of the test data received. The test data have been added to the docket
for the applicable TSCA section 4 test rule and can be found by
referencing the document ID numbers provided. EPA reviews of test data
will be added to the same docket upon completion.
    4. Ecotoxicity. Toxicity to Microorganisms. The document ID number
assigned to this data is EPA-HQ-OPPT-2009-0112-0265.

List of Subjects

    Environmental protection, Hazardous substances, Reporting and
Recordkeeping requirements.

    Dated: June 27, 2014.
Maria J. Doe,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
[FR Doc. 2014-15762 Filed 7-3-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51459-51460]
[FR Doc No: 2011-21045]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Office of Commercial Space Transportation (AST); Notice of
Availability of the Record of Decision (ROD) for the Federal Aviation
Administration (FAA)/AST To Issue, Renew, or Modify Launch Operator
Licenses for Launch Vehicles Covered Under the Evolved Expendable
Launch Vehicle (EELV) Program, Which Include Atlas V and Delta IV
Vehicles, From Cape Canaveral Air Force Station (CCAFS), Florida and
Vandenberg Air Force Base (VAFB), California

AGENCY: Federal Aviation Administration, DOT.

ACTIONS: Notice of Availability.

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SUMMARY: In accordance with the National Environmental Policy Act
(NEPA) of 1969, 42 United States Code U.S.C. 4321-4347 (as amended),
Council on Environmental Quality (CEQ) NEPA implementing regulations
(40 Code of Federal Regulations [CFR parts 1500-1508]), and FAA Order
1050.1E, Change 1, the FAA is announcing the availability of its ROD
for the FAA/AST to issue, renew, or modify launch operator licenses for
launch vehicles covered under the EELV Program from CCAFS and VAFB. The
ROD was prepared to document FAA/AST's decision to issue, renew, or
modify launch operator licenses for launch vehicles covered under the
EELV Program from CCAFS and VAFB.
    The FAA participated as a cooperating agency with the U.S. Air
Force (USAF) in the preparation of the 1998 Final Environmental Impact
Statement for the EELV Program (1998 FEIS) and the 2000 Supplemental
Environmental Impact Statement for the EELV Program (2000 SEIS). The
1998 FEIS preferred alternative analyzed a maximum of 30 combined FAA/
AST-licensed launches and non-FAA/AST licensed launches of Atlas V and
Delta IV in one year from VAFB and CCAFS, combined. The 2000 SEIS
analyzed the environmental impacts of up to five solid-propellant
strap-on rocket motors (SRMs) on the Atlas V medium lift vehicle and
larger SRMs on the Delta IV vehicle. In addition, the 2000 SEIS
considered a maximum of 33 combined

FAA/AST-licensed launches and non-FAA/AST licensed launches of Atlas V
and Delta IV occurring in one year from VAFB and CCAFS, combined. The
USAF issued RODs based on the findings of the 1998 FEIS and the 2000
SEIS.
    In 2003, changes in USAF programs resulted in a need for SLC-3E at
VAFB to be used for Atlas V launches rather than SLC-3W as originally
planned. In 2003, the USAF prepared a Final Environmental Assessment
for the Atlas V System at SLC-3E (2003 EA). The EA supplemented and
updated the previous NEPA evaluation of implementing the Atlas V
program as analyzed in the 1998 FEIS and 2000 SEIS. The 2003 EA
analyzed the environmental impacts associated with the proposed action
of modifying existing facilities and roadways and launching the Atlas V
up to four times annually from SLC-3E at VAFB. The FAA did not
participate as a cooperating agency with the USAF in preparation of the
2003 EA, but has independently evaluated the information contained in
the 2003 EA and has verified the continued validity of the analysis
contained in the document. The FAA has therefore, adopted the 2003 EA
and issued a Finding of No Significant Impact. The analysis from the
2003 EA and the FAA's findings on that analysis are incorporated by
reference in the ROD, and therefore references from the 1998 FEIS and
2000 SEIS to SLC-3W at VAFB have been revised to read ``SLC-3E''
throughout the ROD.
    Under the FAA's Proposed Action, FAA/AST could issue, renew, or
modify launch operator licenses for Atlas V and Delta IV operations at
CCAFS and VAFB. The 1998 FEIS and 2000 SEIS analyzed the full potential
scope of the operations that could be covered under a launch operator
license for Atlas V and Delta IV at CCAFS and VAFB. The FAA's Proposed
Action has been identified as the Preferred Alternative.
    Under the No Action Alternative, the FAA would not issue, renew, or
modify launch operator licenses for Atlas V or Delta IV expendable
launch vehicles at CCAFS and VAFB. Without a license, there could not
be any FAA/AST-licensed commercial launches of Atlas V or Delta IV
vehicles from CCAFS or VAFB; however, non-FAA/AST licensed or
government launches of these vehicles could continue from both
locations. The ROD addresses the potential environmental impacts of the
FAA's Proposed Action and the FAA's No Action Alternative.
    In accordance with the requirements of FAA Order 1050.1E, Change 1,
paragraph 515, the FAA has independently evaluated the information
contained in the 1998 FEIS and 2000 SEIS and has verified the continued
validity of the analysis contained in both documents. Through this re-
evaluation, the FAA has determined that the 1998 FEIS and 2000 SEIS
sufficiently address the concerns of the FAA and comply with FAA
requirements for implementing NEPA as stated in FAA Order 1050.1E,
Change 1. The FAA has also determined that there is no new information
or analysis that would require preparation of a new or supplemental EIS
according to the CEQ Regulations (40 CFR 1502.9(c)(1)). The FAA is
therefore adopting the 1998 FEIS and 2000 SEIS, and is using these
documents to support its decision as stated in the ROD. The FAA has
posted the ROD on the FAA Office of Commercial Space Transportation Web
site at http://www.faa.gov/about/office_org/headquarters_offices/ast/.
    Additional Information: Under the Proposed Action, the FAA/AST
could issue, renew, or modify launch operator licenses for Atlas V and
Delta IV operations at CCAFS and VAFB. The 1998 FEIS and 2000 SEIS
analyzed the full potential scope of the operations that could be
covered under a launch operator license for Atlas V and Delta IV at
CCAFS and VAFB. The 1998 FEIS analyzed the operation of both medium and
heavy lift expendable, orbital ``concept vehicles'' (later known as the
Atlas V and Delta IV families of vehicles) from CCAFS and VAFB. Delta
IV launches would occur from Space Launch Complex-37 (SLC-37) at CCAFS
and from SLC-6 at VAFB; the Atlas V launches would occur from SLC-41 at
CCAFS and from SLC-3E at VAFB. Under the preferred alternative in the
1998 FEIS, a maximum of 30 combined FAA/AST-licensed launches and non-
FAA/AST licensed launches of Atlas V and Delta IV would occur in one
year from VAFB and CCAFS, combined. Under the No Action Alternative,
the USAF would not proceed with the development and deployment of the
EELV program, and Atlas IIA, Delta II, and Titan IVB launch vehicles
would continue to be used to support space launches to meet the
requirements of the government.
    Under the Proposed Action in the 2000 SEIS, up to five solid-
propellant strap-on rocket motors (SRMs) would be added to the Atlas V
medium lift vehicle and larger SRMs would be used on the Delta IV
vehicle. The Atlas V vehicle would launch from SLC-41 at CCAFS and SLC-
3E at VAFB, and the Delta IV vehicle would launch from SLC-37 at CCAFS
and SLC-6 at VAFB. While use of SRM-assisted vehicles was considered in
the 1998 FEIS, the 2000 SEIS considered a higher proportion of vehicles
using SRM-assisted vehicles than the 1998 FEIS. Under the Proposed
Action in the 2000 SEIS, a maximum of 33 combined FAA/AST-licensed
launches and non-FAA/AST licensed launches of Atlas V and Delta IV
would occur in one year from VAFB and CCAFS, combined. Under the No
Action Alternative, the EELV program would continue, except that SRMs
would not be added to the Atlas V launch vehicles and smaller SRMs
would be used on Delta IV launch vehicles.
    The FAA has determined the analysis of impacts presented in the
1998 FEIS and 2000 SEIS represents the best available information
regarding the potential impacts associated with the FAA's regulatory
responsibilities described in the ROD. The 1998 FEIS and 2000 SEIS are
therefore incorporated by reference and summarized as necessary in the
ROD.
    Resource areas were considered to provide a context for
understanding and assessing the potential environmental effects of the
FAA's Proposed Action, with attention focused on key issues. The
resource areas considered in the ROD include air quality; biological
resources; cultural resources; geology and soils; land use and section
4(f) resources; noise; physical resources (Water Resources [Surface
Water, Ground Water, Floodplains], Hazardous Materials, Pollution
Prevention, and Solid Waste); and socioeconomics, environmental
justice, and children's environmental health and safety. Potential
cumulative impacts of the Proposed Action are also addressed in the
ROD.

FOR FURTHER INFORMATION CONTACT: Mr. Daniel A. Czelusniak,
Environmental Program Lead, Office of Commercial Space Transportation,
Federal Aviation Administration, 800 Independence Ave., SW., Suite 325,
Washington, DC 20591, by e-mail at<EMAIL_ADDRESS>or by
phone at<PHONE_NUMBER>.

    Issued in Washington, DC, on August 12, 2011.
Michael McElligott,
Manager, Space Transportation Development Division.
[FR Doc. 2011-21045 Filed 8-17-11; 8:45 am]
BILLING CODE 4910-13-P