[Federal Register Volume 76, Number 102 (Thursday, May 26, 2011)]
[Proposed Rules]
[Pages 30600-30602]
[FR Doc No: 2011-13068]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0195; FRL-9311-8]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Revisions to Clean Air Interstate Rule Emissions Trading
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia. The revision, which
amends the Virginia Clean Air Interstate Rule (CAIR) trading program,
is comprised of technical corrections and revisions to the definition
of a cogeneration unit to ensure the Commonwealth's CAIR trading
program is consistent with Federal CAIR requirements. This action is
being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before June 27, 2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0195 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0195, Cristina Fernandez, Associate
Director, Office of Air Quality Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0195. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The

http://www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy 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: Marilyn Powers,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. On September 27, 2010, the
Commonwealth of Virginia Department of Environmental Quality (VADEQ)
submitted a revision to its SIP, including technical corrections and
revisions to the definition of a cogeneration unit to ensure the
Commonwealth's CAIR trading program is consistent with Federal CAIR
requirements.

I. Background

    EPA approved Virginia's CAIR trading program on December 28, 2007
(72 FR 73602). In the notice of proposed rulemaking (NPR) for
Virginia's CAIR trading program (72 FR 54385, September 25, 2007), EPA
noted that it believed that Virginia clearly intended to replace the
CAIR Federal Implementation Plan (FIP) with a State plan based on the
CAIR model rule that would allow subject sources, non-EGUs from its
Nitrogen Oxides (NOX) SIP Call budget trading program, and
opt-in units meeting the CAIR opt-in criteria to participate in the
EPA-administered regional CAIR trading program. However, EPA also noted
that there were some provisions of Virginia CAIR regulations 9 VAC 5
Chapter 140, Parts II, III, and IV that could be interpreted in a way
that might be inconsistent with the Commonwealth's intent. These
provisions pertain to definitions associated with Virginia's
participation in the regional CAIR trading program, definitions
associated with the State's decision to bring its non-EGUs from its
NOX SIP Call budget trading program into the CAIR trading
program, and a definition of the term ``most stringent state or Federal
NOX emissions limitation'' that is based upon the model rule
but had been expanded by the Commonwealth to include the situation
where more than one fuel is allowed by a permit. EPA determined that
VADEQ's interpretations of these provisions, provided in its letter
dated September 12, 2007, clarified the language of the Virginia
regulations and were consistent with having the EPA-administered CAIR
trading program become effective in Virginia. However EPA recommended,
and VADEQ agreed to, promulgation of clarifying amendments to these
provisions at the Commonwealth's earliest opportunity.
    Also, in a rulemaking dated October 19, 2007 (72 FR 59190), EPA
changed the definition of ``cogeneration unit'' in CAIR, the CAIR model
cap and trade rule, and the CAIR FIP with respect to the calculation
methodology for the efficiency standard of a cogeneration unit. The
revised methodology excluded energy input from biomass, making it more
likely that units co-firing biomass would be able to meet the
efficiency standard and qualify for the cogeneration exemption allowed
by CAIR. This change to the Federal requirements was made subsequent to
Virginia's adoption of its CAIR regulations, therefore Virginia is
required to revise its CAIR regulations to incorporate the changes to
the definition of cogeneration unit to allow the exemption for biomass
units to apply to sources in the Commonwealth.

II. Summary of SIP Revision

    On September 27, 2010, VADEQ submitted a SIP revision that amended
Virginia's CAIR regulations. The SIP revision incorporates the
clarifying revisions specified in the September 25, 2007 NPR proposing
approval of Virginia's CAIR regulations and the changes to the
definition of ``cogeneration unit'' made in EPA's revised CAIR
rulemaking dated October 19, 2007. The submission also included several
other technical or administrative corrections to these regulations.
    The SIP revision applies to the CAIR NOX Annual Trading
Program (9 VAC5 Chapter 140, Part II), the CAIR NOX Ozone
Season Trading Program (9 VAC 5 Chapter 140, Part III), and the CAIR
SO2 Annual Trading Program (9 VAC 5 Chapter 140, Part IV).
The provisions of regulations 5-140-1010, 5-140-2010, and 5-140-3010
relating to ``Purpose,'' and the definitions of ``CAIR NOX
Annual Trading Program,'' ``CAIR NOX Ozone Season Trading
Program,'' ``CAIR SO2 Trading Program,'' and ``permitting
authority'' in regulations 5-140-1020, 5-140-2020, and 5-140-3020 are
amended to clarify that the Commonwealth's CAIR sources are full
participants in the EPA-administered regional CAIR trading programs and
that the Virginia CAIR programs are not trading programs only for
sources geographically located within the borders of the Commonwealth.
The definition of ``most stringent state or Federal NOX
emissions limitation'' in regulations 5-140-1020, 5-140-2020, and 5-
140-3020 is amended to clarify that the primary fuel, where it is not
designated in the permit, is the fuel that would result in the lowest
emission rate. Additionally, the provisions of regulations 5-140-1020,
5-140-2020, and 5-140-3020 are amended to reflect the changes to the
definition of ``cogeneration unit'' that were made to the Federal CAIR
program described previously.

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

    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 CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

III. Proposed Action

    EPA is proposing to approve the Virginia SIP revision amending the
Commonwealth's CAIR regulations codified at 9 VAC5 Chapter 140, Parts
I, II, and III, which was submitted on September 27, 2010. EPA's
analysis shows that the revisions are consistent with Federal CAIR
requirements. EPA is soliciting public comments on the issues discussed
in this document. These comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; 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 proposed rule approving Virginia revisions to its
CAIR trading program does not have Tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country located in the state, and
EPA notes that it will not impose substantial direct costs on Tribal
governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Particulate matter, Reporting and recordkeeping requirements,
Sulfur oxides.

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

    Dated: May 9, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2011-13068 Filed 5-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 153 (Friday, August 7, 2020)]
[Notices]
[Page 47962]
[FR Doc No: 2020-17225]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10013-45-OMS]

Request for Nominations to the National and Governmental Advisory
Committees to the U.S. Representative to the Commission for
Environmental Cooperation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of request for nominations.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is inviting
nominations from a diverse range of qualified candidates to be
considered for appointment to fill vacancies on the National Advisory
Committee (NAC) and the Governmental Advisory Committee (GAC) to the
U.S. Representative to the Commission for Environmental Cooperation
(CEC). Vacancies on these two committees are expected to be selected by
the Fall of 2020. Additional sources may be utilized in the
solicitation of nominees. This notice extends the recruitment period to
receive additional nominees.

DATES: Please submit nominations by August 21, 2020, or two weeks from
the date of this notice, whichever comes later.

ADDRESSES: Submit nominations via email to: Oscar Carrillo, Designated
Federal Officer, Office of Resources and Business Operations, Federal
Advisory Committee Management Division, U.S. Environmental Protection
Agency with subject line COMMITTEE RESUME 2020 to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Designated Federal
Officer, U.S. Environmental Protection Agency; telephone (202) 564-
0347; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The National Advisory Committee and the
Governmental Advisory Committee advise the EPA Administrator in his
capacity as the U.S. Representative to the CEC Council. The Committees
are authorized under Articles 17 and 18 of the North American Agreement
on Environmental Cooperation (NAAEC). Implementation Act, Public Law
103-182, and as directed by Executive Order 12915, entitled ``Federal
Implementation of the North American Agreement on Environmental
Cooperation.'' The NAC and GAC are continued under the authority of
Executive Order 13889, dated September 27, 2019, and operates under the
provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App.
2. The Committees are responsible for providing advice to the United
States Representative on a wide range of strategic, scientific,
technological, regulatory and economic issues related to implementation
and further elaboration of the NAAEC. The National Advisory Committee
consists of 15 representatives from environmental non-profit groups,
business and industry, and educational institutions. The Governmental
Advisory Committee consists of 14 representatives from state, local,
and tribal governments. Members are appointed by the EPA Administrator
for a two-year term. The committees usually meet 3 times per year and
the average workload for committee members is approximately 10 to 15
hours per month. Members serve on the committees in a voluntary
capacity.
    Although we are unable to provide compensation or an honorarium for
your services, you may receive travel and per diem allowances,
according to applicable federal travel regulations. EPA is seeking
nominations from various sectors, i.e., for the NAC we are seeking
nominees from academia, business and industry, and non-governmental
organizations; for the GAC we are seeking nominees from state, local
and tribal government sectors. Nominees will be considered according to
the mandates of FACA, which requires committees to maintain diversity
across a broad range of constituencies, sectors, and groups. EPA values
and welcomes diversity. In an effort obtain nominations of diverse
candidates, EPA encourages nominations of women and men of all racial
and ethnic groups. The following criteria will be used to evaluate
nominees:
     Professional knowledge of the subjects examined by the
committees, including trade & environment issues, the USMCA and ECA,
the NAFTA and NAAEC, and the CEC.
     Represent a sector or group involved in trilateral
environmental policy issues.
     Senior-level experience in the sectors represented on both
committees.
     A demonstrated ability to work in a consensus building
process with a wide range of representatives from diverse
constituencies.
    Nominations must include a resume and a short biography describing
the professional and educational qualifications of the nominee, as well
as the nominee's current business address, email address, and daytime
telephone number. Interested candidates may self-nominate. Anyone
interested in being considered for nomination is encouraged to submit
their application materials by August 21, 2020, or two weeks from the
date of this notice, whichever comes later. To help the Agency in
evaluating the effectiveness of its outreach efforts, please tell us
how you learned of this opportunity. Please be aware that EPA's policy
is that, unless otherwise prescribed by statute, members generally are
appointed for two-year terms.

    Dated: August 3, 2020.
Oscar Carrillo,
Program Analyst.
[FR Doc. 2020-17225 Filed 8-6-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Notices]
[Pages 18618-18620]
[FR Doc No: 2011-7845]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2008-0221]

Operating Limitations at Newark Liberty International Airport

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of Extension to Order.

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SUMMARY: This action amends the Order Limiting Operations at Newark
Liberty International Airport (EWR) that published on May 21, 2008, and
was amended on October 7, 2009. The Order remains effective until the
final Congestion Management Rule for LaGuardia Airport, John F. Kennedy
International Airport, and Newark Liberty International Airport becomes
effective but not later than October 26, 2013.

DATES: This amendment is effective on April 4, 2011.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this Order contact: Gerry Shakley, System Operations Services, Air
Traffic Organization, Federal Aviation Administration, 800 Independence
Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>; facsimile:
(202) 267-7277; e-mail<EMAIL_ADDRESS>    For legal questions concerning this Order contact: Robert Hawks,
Office of the Chief Counsel, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
7240; facsimile:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Availability of Rulemaking Documents

    You may obtain an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    (2) Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/; or
    (3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.
    You also may obtain a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the amendment number or docket number of this
rulemaking.

Background

    Over the past several years, EWR has grown to be one of the most
delay-prone airports in the country. In 2007, demand during peak hours
approached or exceeded the average runway capacity, resulting in
significant volume-related delays. In May 2008, the FAA placed
temporary limits on scheduled operations at EWR to mitigate persistent
congestion and delays at the airport.\1\ This Order also mitigated
FAA's concern about a spillover effect resulting from limiting
operations at John F. Kennedy International Airport (JFK). With a
temporary schedule limit order in place, the FAA proposed a long-term
rule that would limit the number of scheduled and unscheduled
operations at EWR.\2\ On October 10, 2008, the FAA published the
Congestion Management Rule for John F. Kennedy International Airport
and Newark Liberty International Airport, which would have become
effective on December 9, 2008.\3\ That rule was stayed by the U.S.
Court of Appeals for the District of Columbia Circuit and subsequently
rescinded by the FAA.\4\ This Order was further extended on October 7,
2009.\5\
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    \1\ 73 FR 29550 (May 21, 2008), as amended by 74 FR 51648 (Oct.
7, 2009).
    \2\ 73 FR 29626 (May 21, 2008); Docket FAA-2008-0517.
    \3\ 73 FR 60574, amended by 73 FR 66516 (Nov. 10, 2008).
    \4\ 74 FR 52134 (Oct. 9, 2009).
    \5\ 74 FR 51648.
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    Under the Order, as amended, the FAA (1) maintains the current
hourly limits on 81 scheduled operations at EWR during the peak period;
(2) imposes an 80 percent minimum usage requirement for Operating
Authorizations (OAs) with defined exceptions; (3) provides a mechanism
for withdrawal of OAs for FAA operational reasons; (4) establishes
procedures to allocate withdrawn, surrendered, or unallocated OAs; and
(5) allows for trades and leases of OAs for consideration for the
duration of the Order. Without the operational limitations imposed by
this Order, the FAA expects severe congestion-related delays would
occur at EWR and at other airports throughout the National Airspace
System (NAS).
    The FAA is engaged in a rulemaking effort to implement a long-term
congestion management rule at LaGuardia Airport (LGA), JFK, and EWR.
The FAA anticipates publishing a notice of proposed rulemaking for the
Congestion Management Rule for LaGuardia Airport, John F. Kennedy
International Airport, and Newark Liberty International Airport (RIN
2120-AJ89) during the summer of 2011. To prevent this Order from
expiring prior to a final rule becoming effective, the FAA has
concluded it is necessary to extend the expiration date of this Order
until the final Congestion Management Rule for LaGuardia Airport, John
F. Kennedy International Airport, and Newark Liberty International
Airport becomes effective but not later than

October 26, 2013. This expiration date coincides with the expiration
dates for the Orders limiting scheduled operations at JFK and LGA, as
also amended by notices in today's Federal Register.
    Therefore, the FAA finds that notice and comment procedures under 5
U.S.C. section 553(b) are impracticable and contrary to the public
interest. The FAA further finds that good cause exists to make this
Order effective in less than 30 days.

The Amended Order

    The Order, as amended, is recited below in its entirety.
    1. This Order assigns operating authority to conduct an arrival or
a departure at EWR during the affected hours to the U.S. air carrier or
foreign air carrier identified in the appendix to this Order. The FAA
will not assign operating authority under this Order to any person or
entity other than a certificated U.S. or foreign air carrier with
appropriate economic authority and FAA operating authority under 14 CFR
part 121, 129, or 135. This Order applies to the following:
    a. All U.S. air carriers and foreign air carriers conducting
scheduled operations at EWR as of the date of this Order, any U.S. air
carrier or foreign air carrier that operates under the same designator
code as such a carrier, and any air carrier or foreign-flag carrier
that has or enters into a codeshare agreement with such a carrier.
    b. All U.S. air carriers or foreign air carriers initiating
scheduled or regularly conducted commercial service to EWR while this
Order is in effect.
    c. The Chief Counsel of the FAA, in consultation with the Vice
President, System Operations Services, is the final decisionmaker for
determinations under this Order.
    2. This Order governs scheduled arrivals and departures at EWR from
6 a.m. through 10:59 p.m., Eastern Time, Sunday through Saturday.
    3. This Order takes effect at 6 a.m., Eastern Time, on June 20,
2008, and will expire when the final Congestion Management Rule for
LaGuardia Airport, John F. Kennedy International Airport, and Newark
Liberty International Airport becomes effective but not later than
October 26, 2013.
    4. Under the authority provided to the Secretary of Transportation
and the FAA Administrator by 49 U.S.C. 40101, 40103 and 40113, we
hereby order that:
    a. No U.S. air carrier or foreign air carrier initiating or
conducting scheduled or regularly conducted commercial service at EWR
may conduct such operations without an Operating Authorization assigned
by the FAA.
    b. Except as provided in the appendix to this Order, scheduled U.S.
air carrier and foreign air carrier arrivals and departures will not
exceed 81 per hour from 6 a.m. through 10:59 p.m., Eastern Time.
    c. The Administrator may change the limits if he determines that
capacity exists to accommodate additional operations without a
significant increase in delays.
    5. For administrative tracking purposes only, the FAA will assign
an identification number to each Operating Authorization.
    6. A carrier holding an Operating Authorization may request the
Administrator's approval to move any arrival or departure scheduled
from 6 a.m. through 10:59 p.m. to another half hour within that period.
Except as provided in paragraph seven, the carrier must receive the
written approval of the Administrator, or his delegate, prior to
conducting any scheduled arrival or departure that is not listed in the
appendix to this Order. All requests to move an allocated Operating
Authorization must be submitted to the FAA Slot Administration Office,
facsimile<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>and must
come from a designated representative of the carrier. If the FAA cannot
approve a carrier's request to move a scheduled arrival or departure,
the carrier may then apply for a trade in accordance with paragraph
seven.
    7. For the duration of this Order, a carrier may enter into a lease
or trade of an Operating Authorization to another carrier for any
consideration. Notice of a trade or lease under this paragraph must be
submitted in writing to the FAA Slot Administration Office, facsimile
(202) 267-7277 or e-mail<EMAIL_ADDRESS>and must come from a
designated representative of each carrier. The FAA must confirm and
approve these transactions in writing prior to the effective date of
the transaction. The FAA will approve transfers between carriers under
the same marketing control up to five business days after the actual
operation, but only to accommodate operational disruptions that occur
on the same day of the scheduled operation. The FAA's approval of a
trade or lease does not constitute a commitment by the FAA to grant the
associated historical rights to any operator in the event that slot
controls continue at EWR after this order expires.
    8. A carrier may not buy, sell, trade, or transfer an Operating
Authorization, except as described in paragraph seven.
    9. Historical rights to Operating Authorizations and withdrawal of
those rights due to insufficient usage will be determined on a seasonal
basis and in accordance with the schedule approved by the FAA prior to
the commencement of the applicable season.
    a. For each day of the week that the FAA has approved an operating
schedule, any Operating Authorization not used at least 80% of the time
over the period authorized by the FAA under this paragraph will be
withdrawn by the FAA for the next applicable season except:
    i. The FAA will treat as used any Operating Authorization held by a
carrier on Thanksgiving Day, the Friday following Thanksgiving Day, and
the period from December 24 through the first Saturday in January.
    ii. The Administrator of the FAA may waive the 80% usage
requirement in the event of a highly unusual and unpredictable
condition which is beyond the control of the carrier and which affects
carrier operations for a period of five consecutive days or more.
    b. Each carrier holding an Operating Authorization must forward in
writing to the FAA Slot Administration Office a list of all Operating
Authorizations held by the carrier and for each Operating
Authorization, along with a listing of the Operating Authorizations
and:
    i. The dates within each applicable season on which it intends to
commence and to cease scheduled operations.
    A. For each winter scheduling season, the report must be received
by the FAA no later than August 15 during the preceding summer.
    B. For each summer scheduling season, the report must be received
by the FAA no later than January 15 during the preceding winter.
    ii. The completed operations for each day of the applicable
scheduling season:
    A. No later than September 1 for the summer scheduling season.
    B. No later than January 15 for the winter scheduling season.
    iii. A final report of the completed operations for each day of the
scheduling season within 30 days after the last day of the applicable
scheduling season.
    10. In the event that a carrier surrenders to the FAA any Operating
Authorization assigned to it under this Order or if there are
unallocated Operating Authorizations, the FAA will determine whether
the Operating Authorizations should be reallocated. The FAA may
temporarily allocate an Operating Authorization at its discretion. Such
temporary allocations will not be entitled to historical status

for the next applicable scheduling season under paragraph 9.
    11. If the FAA determines that an involuntary reduction in the
number of allocated Operating Authorizations is required to meet
operational needs, such as reduced airport capacity, the FAA will
conduct a weighted lottery to withdraw Operating Authorizations to meet
a reduced hourly or half-hourly limit for scheduled operations. The FAA
will provide at least 45 days' notice unless otherwise required by
operational needs. Any Operating Authorization that is withdrawn or
temporarily suspended will, if reallocated, be reallocated to the
carrier from which it was taken, provided that the carrier continues to
operate scheduled service at EWR.
    12. The FAA will enforce this Order through an enforcement action
seeking a civil penalty under 49 U.S.C. 46301(a). A carrier that is not
a small business as defined in the Small Business Act, 15 U.S.C. 632,
will be liable for a civil penalty of up to $25,000 for every day that
it violates the limits set forth in this Order. A carrier that is a
small business as defined in the Small Business Act will be liable for
a civil penalty of up to $10,000 for every day that it violates the
limits set forth in this Order. The FAA also could file a civil action
in U.S. District Court, under 49 U.S.C. 46106, 46107, seeking to enjoin
any air carrier from violating the terms of this Order.
    13. The FAA may modify or withdraw any provision in this Order on
its own or on application by any carrier for good cause shown.

    Issued in Washington, DC, on March 28, 2011.
Rebecca B. MacPherson,
Assistant Chief Counsel for Regulations.
[FR Doc. 2011-7845 Filed 4-1-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 69 (Wednesday, April 12, 2017)]
[Notices]
[Pages 17712-17714]
[FR Doc No: 2017-07311]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80388; File No. 4-709]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Order Approving and Declaring Effective a Proposed Plan for
the Allocation of Regulatory Responsibilities Between the Financial
Industry Regulatory Authority, Inc. and BOX Options Exchange LLC

April 6, 2017.
    On March 3, 2017, BOX Options Exchange LLC (``BOX'') and the
Financial Industry Regulatory Authority, Inc. (``FINRA'')
(collectively, the ``Parties'') filed with the Securities and Exchange
Commission (``Commission'' or ``SEC'') a plan for the allocation of
regulatory responsibilities, dated March 2, 2017 (``17d-2 Plan'' or the
``Plan''). The Plan was published for comment on March 21, 2017.\1\ The
Commission received no comments on the Plan. This order approves and
declares effective the Plan.
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    \1\ See Securities Exchange Act Release No. 80240 (March 14,
2017), 82 FR 14560.
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I. Introduction

    Section 19(g)(1) of the Securities Exchange Act of 1934
(``Act''),\2\ among other things, requires every self-regulatory
organization (``SRO'') registered as either a national securities
exchange or national securities association to examine for, and enforce
compliance by, its members and persons associated with its members with
the Act, the rules and regulations thereunder, and the SRO's own rules,
unless the SRO is relieved of this responsibility pursuant to Section
17(d) or Section 19(g)(2) of the Act.\3\ Without this relief, the
statutory obligation of each individual SRO could result in a pattern
of multiple examinations of broker-dealers that maintain memberships in
more than one SRO (``Common Members''). Such regulatory duplication
would add unnecessary expenses for common members and their SROs.
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    \2\ 15 U.S.C. 78s(g)(1).
    \3\ 15 U.S.C. 78q(d) and 15 U.S.C. 78s(g)(2), respectively.
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    Section 17(d)(1) of the Act \4\ was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\5\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules, and regulations, or to perform other
specified regulatory functions.
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    \4\ 15 U.S.C. 78q(d)(1).
    \5\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\6\ Rule 17d-1 authorizes the
Commission to name a single SRO as the designated examining authority
(``DEA'') to examine common members for compliance with the financial
responsibility requirements imposed by the Act, or by Commission or SRO
rules.\7\ When an SRO has been named as a common member's DEA, all
other SROs to which the common member belongs are relieved of the
responsibility to examine the firm for compliance with the applicable
financial responsibility rules. On its face, Rule 17d-1 deals only with
an SRO's obligations to enforce member compliance with financial
responsibility requirements. Rule 17d-1 does not relieve an SRO from
its

obligation to examine a common member for compliance with its own rules
and provisions of the federal securities laws governing matters other
than financial responsibility, including sales practices and trading
activities and practices.
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    \6\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2, respectively.
    \7\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18808 (May 7, 1976).
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    To address regulatory duplication in these and other areas, the
Commission adopted Rule 17d-2 under the Act.\8\ Rule 17d-2 permits SROs
to propose joint plans for the allocation of regulatory
responsibilities with respect to their common members. Under paragraph
(c) of Rule 17d-2, the Commission may declare such a plan effective if,
after providing for appropriate notice and comment, it determines that
the plan is necessary or appropriate in the public interest and for the
protection of investors; to foster cooperation and coordination among
the SROs; to remove impediments to, and foster the development of, a
national market system and a national clearance and settlement system;
and is in conformity with the factors set forth in Section 17(d) of the
Act. Commission approval of a plan filed pursuant to Rule 17d-2
relieves an SRO of those regulatory responsibilities allocated by the
plan to another SRO.
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    \8\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49091 (November 8, 1976).
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II. Proposed Plan

    The proposed 17d-2 Plan is intended to reduce regulatory
duplication for firms that are common members of both BOX and FINRA.\9\
Pursuant to the proposed 17d-2 Plan, FINRA would assume certain
examination and enforcement responsibilities for common members with
respect to certain applicable laws, rules, and regulations.
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    \9\ The proposed 17d-2 Plan refers to these common members as
``Dual Members.'' See Paragraph 1(c) of the proposed 17d-2 Plan.
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    The text of the Plan delineates the proposed regulatory
responsibilities with respect to the Parties. Included in the proposed
Plan is an exhibit (the ``BOX Options Exchange LLC Rules Certification
for 17d-2 Agreement with FINRA,'' referred to herein as the
``Certification'') that lists every BOX rule for which FINRA would bear
responsibility under the Plan for overseeing and enforcing with respect
to BOX members that are also members of FINRA and the associated
persons therewith (``Dual Members'').
    Specifically, under the 17d-2 Plan, FINRA would assume examination
and enforcement responsibility relating to compliance by Dual Members
with the rules of BOX that are substantially similar to the applicable
rules of FINRA \10\ delineated in the Certification (``Common Rules'').
In the event that a Dual Member is the subject of an investigation
relating to a transaction on BOX, the plan acknowledges that BOX may,
in its discretion, exercise concurrent jurisdiction and responsibility
for such matter.\11\
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    \10\ See paragraph 1(b) of the proposed 17d-2 Plan (defining
Common Rules). See also paragraph 1(f) of the proposed 17d-2 Plan
(defining Regulatory Responsibilities). Paragraph 2 of the Plan
provides that annually, or more frequently as required by changes in
either BOX rules or FINRA rules, the parties shall review and
update, if necessary, the list of Common Rules. Further, paragraph 3
of the Plan provides that BOX shall furnish FINRA with a list of
Dual Members, and shall update the list no less frequently than once
each calendar quarter.
    \11\ See paragraph 6 of the proposed 17d-2 Plan.
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    Under the Plan, BOX would retain full responsibility for
surveillance, examination, investigation, and enforcement with respect
to trading activities or practices involving BOX's own marketplace,
including, without limitation, registration pursuant to its applicable
rules of associated persons (i.e., registration rules that are not
Common Rules); its duties as a DEA pursuant to Rule 17d-1 under the
Act; and any BOX rules that are not Common Rules.\12\
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    \12\ See paragraph 2 of the proposed 17d-2 Plan.
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III. Discussion

    The Commission finds that the proposed Plan is consistent with the
factors set forth in Section 17(d) of the Act \13\ and Rule 17d-2(c)
thereunder \14\ in that the proposed Plan is necessary or appropriate
in the public interest and for the protection of investors, fosters
cooperation and coordination among SROs, and removes impediments to and
fosters the development of the national market system. In particular,
the Commission believes that the proposed Plan should reduce
unnecessary regulatory duplication by allocating to FINRA certain
examination and enforcement responsibilities for Dual Members that
would otherwise be performed by BOX and FINRA. Accordingly, the
proposed Plan promotes efficiency by reducing costs to Dual Members.
Furthermore, because BOX and FINRA will coordinate their regulatory
functions in accordance with the Plan, the Plan should promote investor
protection.
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    \13\ 15 U.S.C. 78q(d).
    \14\ 17 CFR 240.17d-2(c).
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    The Commission notes that, under the Plan, BOX and FINRA have
allocated regulatory responsibility for those BOX rules, set forth in
the Certification, that are substantially similar to the applicable
FINRA rules in that examination for compliance with such provisions and
rules would not require FINRA to develop one or more new examination
standards, modules, procedures, or criteria in order to analyze the
application of the rule, or a Dual Member's activity, conduct, or
output in relation to such rule. The Common Rules covered by the Plan
are specifically listed in the Certification, as may be amended by the
Parties from time to time.
    According to the Plan, BOX will review the Certification, at least
annually, or more frequently if required by changes in either the rules
of BOX or FINRA, and, if necessary, submit to FINRA an updated list of
Common Rules to add BOX rules not included on the then-current list of
Common Rules that are substantially similar to FINRA rules; delete BOX
rules included in the then-current list of Common Rules that are no
longer substantially similar to FINRA rules; and confirm that the
remaining rules on the list of Common Rules continue to be BOX rules
that are substantially similar to FINRA rules.\15\ FINRA will then
confirm in writing whether the rules listed in any updated list are
Common Rules as defined in the Plan. Under the Plan, BOX will also
provide FINRA with a current list of Dual Members and shall update the
list no less frequently than once each quarter.\16\ The Commission
believes that these provisions are designed to provide for continuing
communication between the Parties to ensure the continued accuracy of
the scope of the proposed allocation of regulatory responsibility.
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    \15\ See paragraph 2 of the Plan.
    \16\ See paragraph 3 of the Plan.
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    The Commission is hereby declaring effective a Plan that, among
other things, allocates regulatory responsibility to FINRA for the
oversight and enforcement of all BOX rules that are substantially
similar to the rules of FINRA for Dual Members of BOX and FINRA.
Therefore, modifications to the Certification need not be filed with
the Commission as an amendment to the Plan, provided that the Parties
are only adding to, deleting from, or confirming changes to BOX rules
in the Certification in conformance with the definition of Common Rules
provided in the Plan. However, should the Parties decide to add a BOX
rule to the Certification that is not substantially similar to a FINRA
rule; delete a BOX rule from the Certification that is substantially
similar to a FINRA rule; or leave on the Certification a BOX rule that
is no longer substantially similar to a FINRA rule, then such a change
would constitute an amendment to the Plan,

which must be filed with the Commission pursuant to Rule 17d-2 under
the Act.\17\
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    \17\ The Commission also notes that the addition to or deletion
from the Certification of any federal securities laws, rules, and
regulations for which FINRA would bear responsibility under the Plan
for examining, and enforcing compliance by, Dual Members, also would
constitute an amendment to the Plan.
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IV. Conclusion

    This Order gives effect to the Plan filed with the Commission in
File No. 4-709. The Parties shall notify all members affected by the
Plan of their rights and obligations under the Plan.
    It is therefore ordered, pursuant to Section 17(d) of the Act, that
the Plan in File No. 4-709, between FINRA and BOX, filed pursuant to
Rule 17d-2 under the Act, is approved and declared effective.
    It is further ordered, that BOX is relieved of those
responsibilities allocated to FINRA under the Plan in File No. 4-709.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(34).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-07311 Filed 4-11-17; 8:45 am]
 BILLING CODE 8011-01-P


4 Reviewed by: Chris A. Wozniak, Ph. D., Biologist, OPP / BPPD 9/ 10/ 2002 Secondary Reviewer: John L. Kough, Ph. D., Biologist, OPP / BPPD / s/ MRID No.: 455845 01 Active Ingredients: Bacillus thuringiensis strain PS149B1 ( NRRL B 21553) binary insect control proteins as expressed in maize Product Name: PS149B1 insect control proteins as expressed in maize Confidentiality: No claims of confidentiality are made for any of the information contained in this study on the basis of its falling within the scope of FIFRA 10 ( d)( 1)( A)( B), or ( C). ID No.: 1G06279; 68467 EUP 5 Submission No.: S610440 Chemical No.: 006430 Bacillus thuringiensis PS149B1 proteins DP Barcode: D281021 Sponsor: Dow AgroSciences LLC, 9330 Zionsville Rd., Indianapolis, IN 46268. Authors: R. A. Herman Testing Facility: Dow AgroSciences, 5501 Oberlin Drive, San Diego, CA 92121 Study Titles: Heat lability of individual proteins of the PS149B1 binary ICP Study Date: January 7, 2002 Study No.: 010144 Conclusion: The decrease in growth inhibition activity following heating of the 14 kDa and 44 kDa mixture suggests that heat treatment at 60

C for 30 minutes is sufficient to denature at least one of the necessary components of the ICP. No mortality effect was seen with the Cry protein treatments, as expected with the southern corn rootworm larval assay. The author suggests that the degree of inhibition ( 30 to 42 % growth inhibition) seen following heat treatment of the mixture is typical of an inactive protein preparation as observed in previous assays. This difference between the larval weights observed with the ICP  temperature treatments and the buffer control was termed a non specific effect, attributed to the presence of proteins in the diet. The 44 kDa protein in the ICP was denatured by treatment at 60

C and higher temperatures as indicated by the lack of response to a 14kDa protein spike. The decreased activity seen in the 44 kDa spike of the heated ICP as temperature of incubation was increased indicates that the 14 kDa protein was more heat stable than the 44 kDa protein. The relative insect activity ( i. e., growth inhibition) as correlated with temperature increase shows the relative stability of the 14 kDa protein at 60

C and 75

C, but its denaturation to background levels ( i. e., 36 % growth inhibition compared to buffer control) at 90

C. The observed growth inhibitory response of the 44 kDa protein alone ( 25 % inhibition) was not observed previously nor expected.

Classification: Supplemental. The registrant needs to further examine or explain the non specific ` protein effect' seen as a net decrease in insect larval weight of 30 % to 42 %, as compared to the negative ( buffer) control. The inhibitory effect of 5 the 44 kDa protein when fed alone to larvae also requires some further inquiry.

Good Laboratory Practices: This study was conducted in compliance with the Certification of Good Laboratory Practices as outlined in 40 CFR 160, with the following exceptions: purity, solubility, stability and uniformity analyses were not conducted on the treatment mixtures applied to the test substrate or for the treated test substrates; insect source of supply / care and diet preparation / delivery were conducted. under non GLP conditions prior to receipt in the Regulatory Laboratories GLP Laboratory.

Purpose: To examine the stability of the two insecticidal crystal proteins, designated as Cry34Ab1 ( 14 kDa) and Cry35Ab1 ( 44 kDa), to heat treatment, as measured by the percent growth inhibition observed in a Southern Corn Rootworm feeding assay.

METHODS Test Substances  The insecticidal crystal protein found in Bacillus thuringiensis strain PS149B1 consists of two proteins referred to as Cry34Ab1 and Cry35Ab1. Their molecular masses are 14 kDa and 44 kDa, respectively. Powder containing 54 % of the 14 kDa   endotoxin ( Cry34Ab1) and a separate powder containing 37 % of the 44 kDa   endotoxin ( Cry35Ab1) were produced in Pseudomonas fluorescens. The 14 kDa powder is referenced as TSN 102172 and the 44 kDa powder as TSN 102171.

Heat treatment and bioassay  A proprietary diet formulated for culture of the southern corn rootworm ( SCR), Diabrotica undecimpunctata howardi, was used as the delivery medium for the Cry34/ 35   endotoxins. Aqueous formulations of these two insecticidal crystal proteins ( ICP) were spread onto the surface of the agar based diet and the diet infested with one neonate larva of the SCR per well of a 128 well bioassay tray.

To provide for distinction between the thermolability of the two proteins, which are typically both needed for insecticidal or growth inhibition effects, the heated ICP ( combination of both proteins) was spiked with non heated samples of the individual proteins. The two ICP proteins were mixed at a 50: 1 ( 14 kDa: 44kDa) mass ratio to avoid suspending excess 44 kDa protein in the formulation since this has been shown to add little to the potency when applied at higher ratios.

Each of the two proteins was formulated on the day of testing and diluted ( or mixed) as needed in 10 mM potassium phosphate buffer ( pH 7.5). A full description of the dilution and mixing protocol for the assay is attached as Figure 1. A solution containing a mixture of the two proteins was divided into 4 portions and held for 30 minutes at 4

C ( refrigerated), 60

C, 75

C, or 90 6

C in a water bath. After incubation at the various temperatures, the vials containing the proteins were placed on ice. The solutions were then either diluted further or spiked with individual nonheated protein solutions to comprise the treatments as listed in Table 1 ( attached).

Controls included in the experiment were buffer alone ( 10 mM potassium phosphate) or nonheated individual proteins ( i. e., Cry34Ab1, Cry35Ab1).

Approximately 500 µ L of a proprietary Western corn rootworm diet was placed into each well of a 128 well bioassay tray. The protein formulations described above were applied to each of 16 wells ( 50 µ L to each well of surface area 1.5 cm2) per treatment. The negative control treatment ( phosphate buffer) was applied to 3 x 16 wells. After the test material dried to the diet surface, a single neonate SCR larva was added to each well. The tray was covered with a vented lid and incubated at approximately 26

C. Eggs were hatched at 15 to 33

C for production of neonates.

Data Analysis  Growth inhibition was calculated by comparing the treatment larval weights to the negative control ( phosphate buffer) weight average. No further statistical analysis was performed.

RESULTS AND DISCUSSION As expected, there was no useful mortality data in that the positive control ( proteins at 4

C) showed only evidence of growth inhibition in SCR larvae. The treatments resulted in growth inhibition responses as follows in Table 2. Although not evidenced in previous bioassays, a ` nonspecific protein effect' was suggested as an explanation for the observed growth inhibition ( 30 to 42 %) of SCR larvae and for the failure of the temperature treatment to inactivate the growth inhibiting ability of the protein mixtures. This phenomenon had not been noted previously by the registrant. The apparent growth inhibitory response of the 44 kDa protein alone ( 25 % inhibition) was also not seen previously in similar experiments.

The decrease in growth inhibition activity following heating of the 14 kDa and 44 kDa mixture suggests that heat treatment at 60

C for 30 minutes is sufficient to denature at least one of the necessary components of the ICP. The author suggests that the degree of inhibition seen, for example, following 60, 75 or 90

C treatment of the mixture, is typical of an inactive protein preparation ( e. g., 30 to 42 % growth inhibition). The difference between the larval weights observed with the ICP  temperature treatments and the buffer control was due to a non specific effect attributed to the presence of proteins in the diet irrespective of the amino acid sequence and conformation of the ICPs. Given the small quantities of protein loaded along with the treatments and the observed degradation of activity with heating, it is not clear how this general protein effect is mediated. Although the SCR diet is proprietary, it is assumed that the formulation must include a protein source which likely dwarfs the amounts of protein added through the addition of Cry protein preparations.

Table 2. 7 Percent SCR Growth Inhibition ( compared to buffer control at the indicated temperature)

Proteins / Temperature 4

C 60

C 75

C 90

C 14 kDa + 44 kDa ( ICP) 92 % 30 % 42 % 33 %

14 kDa alone 68 %

14 kDa spike of ICP   a 72 % 71 % 71 %

44 kDa alone 25 %

44 kDa spike of ICP   82 % 57 % 36 %

a  `   ` = not performed ICP = insecticidal crystal proteins; a mixture of both 14 kDa and 44 kDa proteins at 1: 50 ratio.

The similar values of growth inhibition noted for the heat treated ICP with a 14 kDa spike and the 14 kDa protein alone ( 4

C) , 71 % vs. 68 %, suggests that the 44 kDa protein in the ICP was denatured by treatment at 60

C and higher. It would have been helpful to have data from the treatments of the 14 kDa and 44 kDa proteins alone at 60

C and higher temperatures for comparison. It is not clear why these treatments were not included.

The restoration of activity with the 44 kDa spike of the heated ICP indicates that the 14 kDa protein was more heat stable than the 44 kDa protein. The decrease in insect activity with increased incubation temperature shows the relative stability of the 14 kDa protein at 60

C and 75

C, but its denaturation to background levels ( i. e., 36 % growth inhibition compared to buffer control) at 90

C. The lack of increased activity following addition of the 14 kDa protein to the heated ICP indicates the 44 kDa protein is significantly affected at 60

C.

CONCLUSIONS: The 44 kDa protein of the PS149B1 ICP ( Cry35A) was denatured at relatively low temperatures ( i. e., 60

C or less), while the 14 kDa protein ( Cry34A) is moderately heat tolerant. For a significant effect on insect growth ( corn rootworm complex), both proteins of the ICP are necessary in combination, albeit not necessarily in equimolar amounts. The effects of these proteins on growth of SCR after heat denaturation of the proteins is unclear as to mechanism in that the quantities of protein presented to the larvae are not excessive relative to normal dietary considerations. Compared to control treatment ( i. e., buffer), the 30 to 42 % decline in larval weight accumulation seen in heat treated protein assays suggests that there is either some residual activity present within the test substance or that another factor present is responsible for the activity. A decrease in growth of this magnitude is still biologically significant when comparing the absence of treatment ( i. e., the buffer control) with the Cry34/ 35 ICP treatment. The 25 % growth inhibition observed in the treatment containing the 44 kDa protein alone is also puzzling in that the binary ICP was previously considered as necessary for insecticidal activity. 8 References:

1.) Bacillus thuringiensis Toxin Nomenclature: www. biols. sussex. ac. uk/ home/ Neil_ Crickmore/ Bt/

2.) Review of Product Characterization, Expression Analysis and Acute Oral Toxicity Studies for PS149B1 binary insect control proteins as expressed in maize, a Bacillus thuringiensis based plantpesticide for an experimental use permit; review by Chris A. Wozniak, Ph. D., secondary review by John L. Kough, Ph. D., Senior Scientist, through Mike Mendelsohn, Regulatory Action Leader, June 07, 2001.