[Federal Register: July 31, 2008 (Volume 73, Number 148)]
[Rules and Regulations]
[Page 44630-44632]
[DOCID:fr31jy08-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2006-24825; Directorate Identifier 2006-NE-17-AD;
Amendment 39-15623; AD 2008-16-05]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
(RRD) Dart 528, 529, 532, 535, 542, and 552 Series Turboprop Engines

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

ACTION: Final rule.

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SUMMARY: The FAA is superseding an existing airworthiness directive
(AD) for RRD Dart 528, 529, 532, 535, 542, and 552 Series turboprop
engines. That AD currently requires a dimensional inspection of the
intermediate pressure turbine (IPT) disk or an ultrasonic inspection of
the seal arm contact between the high pressure turbine (HPT) and the
IPT disk seal arm and reworking or replacing the IPT disk if worn
beyond acceptable limits. This AD continues to require those actions.
This AD results from us including an incorrect engine model and
omitting an engine model from the applicability of the existing AD. We
are issuing this AD to prevent HPT disk failure, which can result in an
uncontained engine failure and damage to the airplane.

DATES: This AD becomes effective September 4, 2008. The Director of the
Federal Register previously approved the incorporation by reference of
certain publications listed in the regulations on February 26, 2007 (72
FR 2610, January 22, 2007).

ADDRESSES: You can get the service information identified in this AD
from Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, D-15827
Dahlewitz, Germany; telephone 49 (0) 33-7086-1768; fax 49 (0) 33-7086-
3356.
    The Docket Operations office is located at Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001.

FOR FURTHER INFORMATION CONTACT: Jason Yang, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 by
superseding AD 2007-02-07, Amendment 39-14894 (72 FR 2610, January 22,
2007), with a proposed AD. The proposed AD applies to RRD Dart 528,
529, 532, 535, 542, and 552 Series turboprop engines. We published the
proposed AD in the Federal Register on November 9, 2007 (72 FR 63508).
That action proposed to require deleting the Dart 555 series engines
from the applicability paragraph of the proposed AD, and to list the
Dart 552 series turboprop engines in the applicability paragraph of the
proposed AD.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is provided in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments received.

Request To Correct a Typographical Error in the Costs of Compliance
Section

    One commenter asks us to change ``turbofan engines'' in the Costs
of Compliance Section to ``turboprop engines.'' The commenter states
that the Dart engine is a turboprop engine, not a ``turbofan engines.''
    We agree. We changed ``turbofan engines'' in the Costs to Comply
section to ``turboprop engines.''

Request To Add Airplane Models to the Applicability Paragraph

    The same commenter states that paragraph (c) Applicability, appears
to omit some models of airplanes that might use the engines. The
commenter states that the Dart engine is installed by supplemental type
certificate on certain General Dynamics Convair model airplanes, and
that those airplanes can still be found in the FAA's registry database.
    We partially agree. We must identify in paragraph (c)
Applicability, all engine models that are affected by this AD. We list
the aircraft models that might use those engines to help readers to
determine if they might have an affected engine. However, for clarity,
we

have changed the applicability paragraph to include the General
Dynamics Convair models that might use these engines under supplemental
type certificates.

Change of Compliance End Dates

    We changed the compliance end dates in paragraphs (f)(2)(i) from
June 30, 2007, to June 30, 2008, and paragraph (f)(2)(ii) from April
30, 2008, to July 31, 2008. We changed the compliance dates to avoid
unnecessary grounding of aircraft while still meeting our safety
concerns.

Conclusion

    We have carefully reviewed the available data, including the
comments received, and determined that air safety and the public
interest require adopting the AD with the changes described previously.
We have determined that these changes will neither increase the
economic burden on any operator nor increase the scope of the AD.

Costs of Compliance

    We estimate that this AD will affect 30 RRD Dart 528, 529, 532,
535, 542, and 552 series turboprop engines installed on airplanes of
U.S. registry. We also estimate that it will take about 50 work-hours
per engine to perform the proposed actions, and that the average labor
rate is $80 per work-hour. Required parts will cost about $50,000 per
IPT disk. We estimate that 25 percent, or eight engines, will require
IPT disk replacement. Based on these figures, we estimate the total
cost of the AD to U.S. operators to be $500,000.

Authority for This Rulemaking

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

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration 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 removing Amendment 39-14894 (72 FR
2610, January 22, 2007), and by adding a new airworthiness directive,
Amendment 39-15623, to read as follows:

2008-16-05 Rolls-Royce Deutschland Ltd & Co KG (formerly Rolls-Royce
plc): Amendment 39-15623. Docket No. FAA-2006-24825; Directorate
Identifier 2006-NE-17-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective
September 4, 2008.
    (b) This AD supersedes AD 2007-02-17, Amendment 39-14894.

Applicability

    (c) This AD applies to Rolls-Royce Deutschland Ltd & Co KG (RRD)
Dart 528, 529, 532, 535, 542, and 552 series turboprop engines.
These engines are installed on, but not limited to, Hawker Siddeley,
Argosy AW.650, Fairchild Hiller F-27, F-27A, F-27B, F-27F, F-27G, F-
27J, FH-227, FH-227B, FH-227C, FH-227D, FH-227E, Fokker F.27 all
marks; British Aircraft Corporation Viscount 744, 745D and 810;
Gulfstream G-159, General Dynamics Convair 240D or 600, or 600-240D,
and 340D or 440D, or 640-340D and 640-440D airplanes.

Unsafe Condition

    (d) This AD results from us including an incorrect engine model
and omitting an engine model from the applicability of the existing
AD. We are issuing this AD to prevent HPT disk failure, which can
result in an uncontained engine failure and damage to the airplane.

Compliance

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

Intermediate Pressure Turbine (IPT) Disk and High Pressure Turbine
(HPT)/IPT Disk Seal Arm Inspections

    (f) Within 60 days after the effective date of the AD, do either
of the following:
    (1) Perform a dimensional inspection of the IPT disk and repair
or replace the IPT disk, if necessary using paragraph 3 of the
Accomplishment Instructions of RRD service bulletin (SB) Da72-538,
dated June 10, 2005; or
    (2) Perform an ultrasonic inspection of the disk seal arm
contact between the HPT and the IPT using paragraph 3 of the
Accomplishment Instructions of RRD SB Da72-536, Revision 1, dated
August 25, 2003.
    (i) For RRD Dart 528, 529, 532, 535, 542 series turboprop
engines if wear is outside allowable limits, before June 30, 2008,
perform a dimensional inspection and repair or replace the IPT disk,
if necessary. Use paragraph 3 of the Accomplishment Instructions of
RRD SB Da72-538, dated June 10, 2005.
    (ii) For RRD Dart 552 series turboprop engines if wear is
outside allowable limits, before July 31, 2008, perform a
dimensional inspection and repair or replace the IPT disk, if
necessary. Use paragraph 3 of the Accomplishment Instructions of RRD
SB Da72-538, dated June 10, 2005.
    (iii) If wear is within allowable limits, perform a dimensional
inspection of the IPT disk at the next engine shop visit or at next
overhaul, whichever occurs first and repair or replace the IPT disk,
if necessary. Use paragraph 3 of the Accomplishment Instructions of
RRD SB Da72-538, dated June 10, 2005.

Alternative Methods of Compliance

    (g) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Related Information

    (h) LBA airworthiness directive D-2005-197, dated June 30, 2005,
also addresses the subject of this AD.

    (i) Contact Jason Yang, Aerospace Engineer, Engine Certification
Office, FAA, Engine and Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; telephone<PHONE_NUMBER>, fax
(781) 238-7199; e-mail<EMAIL_ADDRESS>for more information
about this AD.

Material Incorporated by Reference

    (j) You must use the Rolls-Royce Deutschland Ltd & Co KG service
information specified in Table 1 to perform the actions required by
this AD. The Director of the Federal Register previously approved
the incorporation by reference of the service information specified
in Table 1 on February 26, 2007 (72 FR 2610, January 22, 2007).
Contact Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, D-15827
Dahlewitz, Germany; telephone 49 (0) 33-7086-1768; fax 49 (0) 33-
7086-3356 for a copy of this service information. You may review
copies at the FAA, New England Region, 12 New England Executive
Park, Burlington, MA; or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal-register/cfr/ibr-locations.html.

                                       Table 1--Incorporation by Reference
----------------------------------------------------------------------------------------------------------------
       Service Bulletin No.                Page                Revision                       Date
----------------------------------------------------------------------------------------------------------------
Da72-536: Total Pages: 23........  All.................  1...................  August 25, 2003.
Da72-538: Total Pages: 21........  All.................  Original............  June 10, 2005.
----------------------------------------------------------------------------------------------------------------

    Issued in Burlington, Massachusetts, on July 24, 2008.
Carlos Pestana,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E8-17423 Filed 7-30-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 229 (Tuesday, November 29, 2011)]
[Notices]
[Pages 73749-73750]
[FR Doc No: 2011-30794]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 1, 2011 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
December 1, 2011 will be: institution and settlement of injunctive
actions; institution and settlement of administrative proceedings;
adjudicatory matters; and other matters relating to enforcement
proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: November 23, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-30794 Filed 11-25-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66477]
[FR Doc No: 2023-21009]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4715-DR; Docket ID FEMA-2023-0001]

Guam; Amendment No. 4 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster for the
territory of Guam (FEMA-4715-DR), dated May 25, 2023, and related
determinations.

DATES: This amendment was issued August 8, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 8, 2023, the President amended the cost-sharing
arrangements regarding Federal funds provided under the authority of
the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42
U.S.C. 5121 et seq. (the ``Stafford Act''), in a letter to Deanne
Criswell, Administrator, Federal Emergency Management Agency,
Department of Homeland Security, under Executive Order 12148, as
follows:

    I have determined that the damage in the territory of Guam
resulting from Typhoon Mawar during the period of May 22 to May 29,
2023, is of sufficient severity and magnitude that special cost
sharing arrangements are warranted regarding Federal funds provided
under the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford Act'').
    Therefore, I amend my declaration of May 25, 2023, to authorize
Federal funds for all categories of Public Assistance, Hazard
Mitigation, and the Other Needs Assistance portion of the Individual
Assistance program at 90 percent of total eligible costs.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-21009 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19062-19063]
[FR Doc No: 2017-08306]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0868]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Use of Serological Tests To Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components for
Transfusion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by May 25,
2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0681.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry: Use of Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood
Components Intended for Transfusion

OMB Control Number 0910-0681--Extension

    The guidance document implements the donor screening
recommendations for the FDA-approved serological test systems for the
detection of antibodies to T. cruzi. The use of the donor screening
tests are to reduce the risk of transmission of T. cruzi infection by
detecting antibodies to T. cruzi in plasma and serum samples from
individual human donors, including donors of Whole Blood and blood
components intended for transfusion. The guidance recommends that
establishments that manufacture Whole Blood and blood components
intended for transfusion should notify consignees of all previously
collected in-date blood and blood components to quarantine and return
the blood components to establishments or to destroy them within 3
calendar days after a donor tests repeatedly reactive by a licensed
test for T. cruzi antibody. When establishments identify a donor who is
repeatedly reactive by a licensed test for T. cruzi antibodies and for
whom there is additional information indicating risk of T. cruzi
infection, such as testing positive on a licensed supplemental test
(when such test is available) or until such test is available,
information that the donor or donor's mother resided in an area endemic
for Chagas disease (Mexico, Central and South America) or as a result
of other medical diagnostic testing of the donor indicating T. cruzi
infection, we recommend that the establishment notify consignees of all
previously distributed blood and blood components collected during the
lookback period and, if blood and blood components were transfused,
encourage consignees to notify the recipient's physician of record of a
possible increased risk of T. cruzi infection.
    Respondents to this information collection are establishments that
manufacture Whole Blood and blood components intended for transfusion.
We believe that the information collection provisions in the guidance
for establishments to notify consignees and for consignees to notify
the recipient's physician of record in the guidance do not create a new
burden for respondents and are part of usual and customary business
practices. Since the end of January 2007, a number of blood centers
representing a large proportion of U.S. blood collections have been
testing donors using a licensed assay. We believe these establishments
have already developed standard operating procedures for notifying
consignees and for the consignees to notify the recipient's physician
of record.
    The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 601.12 have been approved under OMB control number 0910-0338;
the

collections of information in 21 CFR 606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and 630.40 have been approved under
OMB control numbers 0910-0116 and 0910-0795; the collections of
information in 21 CFR 606.171 have been approved under OMB control
number 0910-0458.
    In the Federal Register of November 7, 2016 (81 FR 78170), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08306 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: November 25, 2005 (Volume 70, Number 226)]
[Notices]
[Page 71116]
[DOCID:fr25no05-55]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-91-000]

Enbridge Pipelines (KPC); Notice of Proposed Changes in FERC Gas
Tariff

November 17, 2005.
    Take notice that on November 14, 2005, Enbridge Pipelines (KPC)
tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, the following tariff sheets to become effective on
December 14, 2005.

First Revised Sheet No. 303
Original Sheet No. 303A
First Revised Sheet No. 315
Original Sheet No. 315A
First Revised Sheet No. 326
Original Sheet No. 326A
First Revised Sheet No. 338
First Revised Sheet No. 339
First Revised Sheet No. 347
First Revised Sheet No. 348
First Revised Sheet No. 359
First Revised Sheet No. 360

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6482 Filed 11-23-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Notices]
[Page 63185]
[DOCID:fr23oc08-79]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1800-DR]

Illinois; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Illinois (FEMA-1800-DR), dated October 3, 2008, and
related determinations.

DATES: Effective Date: October 5, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective October 5, 2008.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-25261 Filed 10-22-08; 8:45 am]

BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Page 35107]
[FR Doc No: 2021-14082]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4558-DR; Docket ID FEMA-2021-0001]

California; Amendment No. 11 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of California (FEMA-4558-DR), dated August 22, 2020, and
related determinations.

DATES: This change occurred on May 14, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Andrew Grant,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of Willie G. Nunn as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-14082 Filed 6-30-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Proposed Rules]
[Pages 56134-56136]
[FR Doc No: 2011-23142]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0701; FRL-9462-4]

Revisions to the California State Implementation Plan, San
Joaquin Valley Unified Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the San Joaquin
Valley Unified Air Pollution Control District (SJVUAPCD) portion of the
California State Implementation Plan (SIP). These revisions concern:
volatile organic compound (VOC) emissions from steam enhanced crude oil
production and aerospace coating operations. We are approving local
rules that regulate these emission sources under the Clean Air Act as
amended in 1990 (CAA or the Act). We are taking comments on this
proposal and plan to follow with a final action. In a separate interim
final action published in the Rules section in today's Federal
Register, we are deferring sanctions that would otherwise apply to the
SJVUAPCD.

DATES: Any comments must arrive by October 12, 2011.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2011-0701, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or e-mail. http://www.regulations.gov is an
``anonymous access'' system, and EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send e-mail directly to EPA, your e-mail address will be
automatically captured and included as part of the public comment. 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.
    Docket: Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov and in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Adrianne Borgia, EPA Region IX, (415)
972-3576<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules and rule
revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations to Further Improve the Rules
    D. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were amended by the local air agency and submitted by the
California Air Resources Board.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
           Local Agency                Rule No.              Rule title               Amended        Submitted
----------------------------------------------------------------------------------------------------------------
SJVUAPCD..........................            4401  Steam-Enhanced Crude Oil            06/16/11        07/28/11
                                                     Production Wells.
SJVUAPCD..........................            4605  Aerospace Assembly and              06/16/11        07/28/11
                                                     Component Coating
                                                     Operations.
----------------------------------------------------------------------------------------------------------------

    On August 3, 2011, EPA determined that the submittal for SJVUAPCD
Rules 4401 and 4605 met the completeness criteria in 40 CFR part 51
Appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    On January 26, 2010 (75 FR 3996) we finalized a limited approval of
versions of Rules 4401 and 4605 that were adopted locally on December
14, 2006 and September 20, 2007 respectively, thereby incorporating
those versions of the two rules into the SIP. We simultaneously
finalized a limited disapproval of the same two rules based on our
identification of deficiencies in each of these rules. SJVUAPCD adopted
revisions to the SIP-approved versions on June 16, 2011 that were
intended to address the deficiencies identified in our January 2010
action, and CARB submitted these revisions to us on July 28, 2011.

C. What is the purpose of the submitted rules and rule revisions?

    SJVUAPCD Rules 4401 and 4605 are both intended to limit emissions
of VOCs, which help produce ground-level ozone and smog that are
harmful to human health and the environment. Section 110(a) of the CAA
requires States to submit regulations that control VOC emissions.
    SJVUAPCD Rule 4401, Steam-Enhanced Crude Oil Production Wells, is
designed to limit VOC emissions at steam-enhanced crude oil production
wells. The rule establishes requirements for inspection, maintenance
and replacement/retrofit of leaking components. It includes
administrative and recordkeeping requirements, such as inspection logs.
The purpose of this rule amendment is to correct the rule deficiency in
Section 6.2.4 as identified by EPA and to clarify existing rule
provisions by removing expired language throughout the rule.
    SJVUAPCD Rule 4605, Aerospace Assembly and Component Coating
Operations, is designed to limit VOC emissions at these operations. The
rule establishes limits for coatings used in the aerospace industry and
defines alternative emission control system requirements. It also
includes recordkeeping, reporting, and monitoring requirements. The
primary purpose of the June 2011 rule amendment is to correct
deficiencies identified by EPA in the January 26, 2010 (75 FR 3996)
final rulemaking on the previous version of this rule.
    EPA's technical support documents (TSDs) for Rules 4401 and 4605
have more information about these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Several statutory provisions apply to EPA's evaluation of the
rules. CAA section 110(a)(2)(A) requires that regulations submitted to
EPA for approval into a SIP must be clear and legally enforceable. CAA
section 110(l) prohibits EPA from approving any SIP revision that would
interfere with any applicable requirement concerning attainment and
reasonable further progress (RFP) or any other applicable requirement
of the CAA, and CAA section 193 prohibits the modification of any SIP-
approved control requirement in effect before November 15, 1990, in a
nonattainment area. CAA section 172(c)(1) requires nonattainment areas
to implement all reasonably available control measures (RACM),
including such reductions in emissions from existing sources in the
area as may be obtained through the adoption, at a minimum, of
reasonably available control technology (RACT), as expeditiously as
practicable. In addition, under CAA section 182(b)(2), ozone
nonattainment areas classified as moderate or above must implement RACT
for all VOC sources covered by a Control Technique Guideline (CTG)
document and for all other major sources of VOCs. The SJVUAPCD
regulates an ozone nonattainment area that is classified as Extreme
under both the one-hour ozone and eight-hour ozone standards (40 CFR
81.305 (2011)) and Rules 4401 and 4605 apply to sources covered by a
CTG document. Therefore, Rules 4401 and 4605 must fulfill RACT
requirements for VOCs.
    Guidance and policy documents that we use to evaluate
enforceability and RACT requirements consistently include the
following:
    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook).
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. EPA's CTG titled, ``Surface Coating Operations at Aerospace
Manufacturing & Rework Operations'' (EPA-453/R-97-004, December 1997).
    4. EPA's CTG titled, ``Control of VOC Emissions from Solvent Metal
Cleaning'' (EPA-450/2-77-022, November 1977) SJVAPCD's 2009 RACT SIP
Demonstration (April 16, 2009).

B. Do the rules meet the evaluation criteria?

    We believe these rules are consistent with the relevant statutory
criteria and guidance regarding enforceability, RACT and SIP
relaxations. We also believe these rules have adequately addressed the
deficiencies identified in our January 26, 2010 action by removing
inappropriate director's discretion in Rule 4401, and adding and
lowering emission limits consistent with the relevant national guidance
in Rule 4605.
    The TSD for each rule has more information on our evaluation.

C. EPA Recommendations To Further Improve The Rules

    The TSDs describe additional rule revisions that we recommend for
the next time the local agency modifies these rules but are not
currently the basis for rule disapproval.

D. Public Comment and Final Action

    Because EPA believes the submitted rules fulfill all relevant
requirements and incorporate revisions that correct the deficiencies
identified for both Rule 4401 and 4605 in the limited disapproval on
January 26, 2010 (75 FR 3996), we are proposing to fully approve them
under section 110(k)(3) of the Act. We will accept comments from the
public on this proposal for the next 30 days. Unless we receive
convincing new information during the comment period, we intend to
publish a final approval action that will incorporate these rules into
the Federally enforceable SIP. Our final action will permanently
terminate the sanctions clocks associated with our January 26, 2010
action on the effective date of the final approval.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed 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) because application of those requirements would

be inconsistent with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this proposed action 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, Intergovernmental
relations, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: August 31, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2011-23142 Filed 9-9-11; 8:45 am]
BILLING CODE 6560-50-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

(7/1/2007)

EPA Biopesticides and Pollution Prevention Division contact: Linda
Hollis,<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
TEMPLATE:

AgraQuest, Inc.

[To be assigned]

	EPA has received a pesticide petition (To be assigned) from AgraQuest,
Inc., 1540 Drew Avenue, Davis, California, 95618 proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

	1. by establishing a tolerance for residues of NA-Remove

	2. to establish an exemption from the requirement of a tolerance for

3. to establish an amendment/expansion of an existing tolerance
exemption for the NA-Remove

(Options (pick one)

	1. microbial pesticide  [insert name of active ingredient] NA-Remove

2. biochemical pesticide Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic (Extract of Chenopodium
ambrosioides near ambrosioides Mimic)

	3. plant-pesticide [insert name of active ingredient] in or on [insert
commodity]. NA-Remove

	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, AgraQuest,
Inc.

 has submitted the following summary of information, data, and arguments
in support of their pesticide petition. This summary was prepared by
AgraQuest, Inc. and EPA has not fully evaluated the merits of the
pesticide petition. The summary may have been edited by EPA if the
terminology used was unclear, the summary contained extraneous material,
or the summary unintentionally made the reader conclude that the
findings reflected EPA’s position and not the position of the
petitioner.

I. AgraQuest, Inc. Petition Summary

	[To be Assigned]

A. Product Name and Proposed Use Practices

	Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is the
active ingredient in the formulated end-use product QRD 400 (EPA Reg.
No. 69592-22), which is intended for use on ornamentals in greenhouses
and nurseries under the brand name Metronome, and  intended for use on a
variety of agricultural crops under the brand name Requiem 25EC.  ECANA
Mimic is the active ingredient in the proposed formulated end-use
product QRD 452.  The formulated products containing either ECANA or
ECANA Mimic are intended for use as contact insecticides / acaricides
for the control or suppression of foliage feeding pests including
lepidopterous larvae, aphids, plant-feeding mites, whiteflies, mealy
bugs, leafminers, thrips, lygus bugs, scale, leaf hoppers, and certain
psyllids.   Like Requiem 25EC, QRD 452 is intended primarily for use on
a variety of agricultural crops.  End-use products consist of an
emulsifiable concentrate formulation that is mixed with water and
applied as a foliar spray with conventional application equipment.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues.

Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is a
biochemical pesticide active ingredient composed of a modified essential
oil extract of Chenopodium ambrosioides near ambrosioides. Chenopodium
is a common plant in the US, Mexico, and Central America and is used as
a spice and herb in cooking.  ECANA is a complex mixture of terpenes and
terpene derivatives, including three main terpenes that make up almost
70% of the mixture. The combination of the three terpenes is considered
to be the active ingredient in ECANA. ECANA Mimic is a blend of the same
three nature-identical terpene components in the same proportions as
found in ECANA. Therefore, the active ingredient in ECANA and ECANA
Mimic is essentially the same. ECANA Mimic and ECANA are contact
insecticide/acaricides. The mode of action has not been completely
determined, however, based on laboratory and field trial observations
the primary mechanism for controlling and suppressing insect pests is
thought to involve the degradation of the cuticle of soft-bodied insects
and mites after contact.

	2. Magnitude of residues at the time of harvest and method used to
determine the residue.

 No residues of Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic are expected to occur at the time of harvest
because the components of the active ingredient are volatile and
dissipate soon after application.  Residue studies have been previously
submitted to support the registration applications for both products.
Data submitted clearly demonstrates that the active ingredient
components are not detectable shortly after application, even at 2 - 4X
the maximum label rate, and as such ECANA and ECANA Mimic will not be
present or detectable at the time of harvest.

	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed.

 	An analytical method for residues is not applicable.  It is expected
that, when used as proposed, Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic would not result in detectable
residues or residues that are of toxicological concern.

C. Mammalian Toxicological Profile

Both Extract of Chenopodium ambrosioides near ambrosioides (ECANA) and
ECANA Mimic contain essentially the same proportions of the three
terpene components. It is not unreasonable to conclude, based on the
similarity in product composition, measured physical/chemical and
residue decline characteristics, and performance results, that data
generated for ECANA can be used to bridge any data gaps for which there
are no corresponding ECANA Mimic toxicity data. Studies to evaluate the
safety to mammals have been conducted on the technical grade active
ingredient ECANA and ECANA Mimic (referred to below as “tgai”) and
on the 25% emulsifiable concentrate end-use products (referred to below
as “25EC”), and are summarized as follows:

1.	Acute Oral Toxicity (OPPTS 870.1100):  Acute Oral LD50s in rats for
ECANA tgai and ECANA 25EC were 2,000 – 5,000 mg/kg and >5,000 mg/kg,
respectively. In comparison, acute Oral LD50s limit tests in rats were >
2,000 mg/kg and >5,000 mg/kg in studies with ECANA Mimic tgai and 25EC
formulation, respectively.

2.	Acute Dermal Toxicity (OPPTS 870.1200):  Dermal LD50 limit test
results for both ECANA tgai and 25EC formulation were > 5,000 mg/kg. In
comparison, dermal LD50 limit test results in rats for both the ECANA
Mimic tgai and 25EC formulation were > 2,020 mg/kg.

Acute Inhalation Toxicity (OPPTS 870.1300):  In acute inhalation
toxicity limit tests no adverse effects or deaths were seen in rats
exposed for four hours to the tgai and the 25EC as an aerosol. The LC50
for the ECANA tgai and ECANA 25EC was > 2.03 mg/L and > 2.02 mg/L,
respectively.

Primary Eye Irritation (OPPTS 870.2400):  In an eye irritation study on
rabbits, the ECANA tgai was classified as mildly to moderately
irritating to the eye.  The ECANA 25 EC was classified as minimally to
mildly irritating.

Primary Dermal Irritation (OPPTS 870.2500):  In a skin irritation study
on rabbits, the ECANA tgai was classified as moderately irritating to
the skin.  In a similar study, the ECANA 25EC was classified as
moderately irritating to the skin.

6. 	Dermal Sensitization (OPPTS 870.2600): In a dermal sensitization
study in Guinea pigs (Buehler method), the ECANA tgai was classified as
a dermal sensitizer. In a similar study, the ECANA 25EC was classified
as a dermal sensitizer. Naïve control animals in both studies did not
have any positive reactions after challenge.

7. 	Genotoxicity (OPPTS 870.5100, 870.5375, and 870.5550):   Three
genotoxicity studies were performed on the ECANA tgai. The results of a
bacterial reverse mutation assay, an in vitro mammalian chromosome
aberration test, and an unscheduled DNA repair assay were all negative.

Waivers were requested and granted for all other Tier 1 biochemical
pesticide data requirements for ECANA, including reproductive and
developmental toxicity, immunotoxicity, sub-chronic toxicity and acute
toxicity to non-target species.  Data waiver rationales were based on
the lack of residues shortly after application; ubiquity in nature of
the terpene components; history of use the main terpene components in
the food, fragrance, and flavoring industries; favorable toxicological
profile in acute toxicological studies; and the inconsequential exposure
resulting from the label-directed use rates. The ECANA data waivers and
rationales are cited in the ECANA Mimic registration application as
fulfilling all the other Tier 1 biochemical pesticide data requirements
for ECANA Mimic.

	The results of toxicity testing with ECANA and ECANA Mimic and
information found in published literature support the conclusion that
the proposed use of AgraQuest’s ECANA or ECANA Mimic poses no
foreseeable risks to human health or the environment. Both dietary and
non-dietary exposures would not be expected to pose any quantifiable
risk due to a lack of residues of toxicological concern.

D. Aggregate Exposure

Dietary exposure.

Dietary exposure from use of Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) and ECANA Mimic, as proposed, is virtually
non-existent.   ECANA and ECANA Mimic are intended for application to
ornamentals and agricultural crops to suppress or control certain insect
pests.  Whereas ECANA is an essential oil derived from a plant that is
common in the US, Mexico, and Central America and is used as a spice and
herb in cooking, ECANA Mimic is a blend of nature-identical components
that substantially replicates the composition and activity of the
plant-derived ECANA.

Food.

	No residues of Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic are expected to occur on food due to the fact
that the components of the active ingredient are volatile and dissipate
soon after application. Residue decline studies on an ornamental and two
food crops with either ECANA or ECANA Mimic demonstrated that multiple
applications of the formulated end-use product at 2 – 4X the label
rates resulted in no detection of residue shortly after application and
no accumulation of residues over multiple applications.

	Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile.   The major terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the three main terpene
components are approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.  The lack
of residues on treated crops, the results of toxicity testing on ECANA
and ECANA Mimic, and information found in published literature on the
main terpene components in ECANA and ECANA Mimic support the conclusion
that the proposed use of AgraQuest’s processed ECANA and ECANA Mimic
poses no foreseeable risks to human health or the environment. Dietary
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern.

	ii. Drinking water.

	Similarly, exposure to humans from residues of Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) or ECANA Mimic in consumed
drinking water would be unlikely.  Potential exposure to surface water
would be negligible and exposure to drinking water (well or ground
water) would be impossible to measure. ECANA and ECANA Mimic are
intended for application to ornamentals and agricultural crops.  The
products are not applied directly to water.

	The lack of residues on treated crops, the results of toxicity testing
with ECANA and ECANA Mimic, as well as information found in published
literature on the main terpene components support the conclusion that
the proposed use of AgraQuest’s processed ECANA and ECANA Mimic poses
no foreseeable risks to human health or the environment.  Drinking water
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern.

	2. Non-dietary exposure.

The potential for non-dietary exposure to the general population,
including infants and children, is limited.  Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) and ECANA Mimic are intended for
application to ornamentals and agricultural crops to control insect
pests.

	The lack of residues on treated crops, the results of toxicity testing
with ECANA and ECANA Mimic, and information found in published
literature on the main terpene components in ECANA and ECANA Mimic
support the conclusion that the proposed use of AgraQuest’s processed
ECANA and ECANA Mimic poses no foreseeable risks to human health or the
environment.  Non-dietary exposures would not be expected to pose any
quantifiable risk due to a lack of residues of toxicological concern.

E. Cumulative Effects

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 It is not expected that,
when used as proposed, Extract of Chenopodium ambrosioides near
ambrosioides (ECANA) or ECANA Mimic would result in residues that are of
toxicological concern. ECANA is an essential oil derived from a plant
that is common in the US, Mexico, and Central America and is used as a
spice and herb in cooking.  ECANA is a complex mixture of terpenes and
terpene derivatives, including three main terpenes that make up almost
70% of the mixture. The combination of the three terpenes is considered
to be the active ingredient in ECANA.  ECANA Mimic is a blend of the
same three nature-identical terpene components in the same proportions
as found in the plant-derived ECANA.

	Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile. The main terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the main terpene components are
approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.

	ECANA and ECANA Mimic are intended for application to ornamentals and
agricultural crops to control insect pests.  The lack of residues on
treated crops, the results of toxicity testing on ECANA and ECANA Mimic,
and information found in published literature on the main terpene
components in ECANA and ECANA Mimic support the conclusion that the
proposed use of AgraQuest’s processed ECANA and ECANA Mimic poses no
foreseeable risks to human health or the environment.

F. Safety Determination

U.S. population.

	Extract of Chenopodium ambrosioides near ambrosioides (ECANA) is an
essential oil derived from a plant that is common in the US, Mexico, and
Central America and is used as a spice and herb in cooking.  ECANA is a
complex mixture of terpenes and terpene derivatives, including three
main terpenes that make up almost 70% of the mixture. The combination of
the three terpenes is considered to be the active ingredient in ECANA.
ECANA Mimic is a blend of the same three nature-identical terpene
components in the same proportions as found in the plant-derived ECANA.
Acute oral and dermal toxicity studies show that ECANA and ECANA Mimic
are not acutely toxic. An acute inhalation toxicity study with ECANA
showed that it was not toxic and is mildly to moderately irritating to
the skin and eyes of mammals. The expectation is that tests with ECANA
Mimic would produce the same toxicological profile. The main terpene
components in ECANA and ECANA Mimic are naturally occurring in a
multitude of fruits, vegetables, herbs, spices, and other foods and
beverages, including coffee, tea, alcoholic beverages, baked and fried
potatoes, bread and cheese.  In addition the main terpene components are
approved as direct food additives by the US Food and Drug
Administration, and are approved as fragrances in cosmetics.

When used as proposed, ECANA and ECANA Mimic would not result in
residues that are of toxicological concern. ECANA and ECANA Mimic are
intended for application to ornamentals and agricultural crops to
control insect pests.  The lack of residues on treated crops, the
results of toxicity testing on ECANA and ECANA Mimic, and information
found in published literature on the main terpene components in ECANA
and ECANA Mimic support the conclusion that the proposed use of
AgraQuest’s processed ECANA and ECANA Mimic poses no foreseeable risks
to human health or the environment.  There is a reasonable certainty of
no harm to the general US population from exposure to these active
ingredients.

	2. Infants and children.

	As mentioned above, it is not expected that, when used as proposed,
Extract of Chenopodium ambrosioides near ambrosioides (ECANA) and ECANA
Mimic would result in residues that are of toxicological concern. There
is a reasonable certainty of no harm for infants and children from
exposure to ECANA and ECANA Mimic from the proposed uses.

G. Effects on the Immune and Endocrine Systems

	To date there is no evidence to suggest that Extract of Chenopodium
ambrosioides near ambrosioides (ECANA) and ECANA Mimic will compromise
the immune or endocrine systems, or that either functions in a manner
similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

	There is no US. EPA Tolerance for Extract of Chenopodium ambrosioides
near ambrosioides (ECANA) or ECANA Mimic.

I. International Tolerances

	A Codex Alimentarius Commission Maximum Residue Level (MRL) is not
required for Extract of Chenopodium ambrosioides near ambrosioides
(ECANA) or ECANA Mimic.

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