[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Proposed Rules]
[Pages 32667-32670]
[FR Doc No: 2019-14502]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0252; Product Identifier 2019-NM-048-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 727 airplanes, Model 757 airplanes,
and Model 767-200, -300, -300F, and -400ER series airplanes. This
proposed AD was prompted by reports of nuisance stick shaker activation
while the airplane accelerated to cruise speed at the top of climb.
This proposed AD was also prompted by an investigation of those reports
that revealed that the angle of attack (AOA) (also known as angle of
airflow) sensor vanes could not prevent the build-up of ice, causing
the AOA sensor vanes to become immobilized, which resulted in nuisance
stick shaker activation. This proposed AD would require a general
visual inspection of the AOA sensors for a part number, and replacement
of affected AOA sensors. We are proposing this AD to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by August 23, 2019.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view

this service information at the FAA, Transport Standards Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2019-0252.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0252; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations (phone: 800-647-
5527) is listed above. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jeffrey W. Palmer, Aerospace Engineer,
Systems and Equipment Section, FAA, Los Angeles ACO Branch, 3960
Paramount Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax:
562-627-5210; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-0252;
Product Identifier 2019-NM-048-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this NPRM. We will consider all
comments received by the closing date and may amend this NPRM because
of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of nuisance stick shaker activation while
the airplane was accelerating to cruise speed at the top of the climb.
A review of recorded flight data and weather reports indicated that the
cause of the nuisance stick shaker activation was immobilized AOA
sensor vanes, which were frozen because the heaters in the AOA sensors
vanes were not sufficient to prevent ice build-up in the AOA sensor
faceplate and vane. This can be caused by water entering the AOA vane
pivot and freezing during takeoff. This condition, if not addressed,
could result in inaccurate or unreliable AOA sensor data being
transmitted to airplane systems and consequent loss of controllability
of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 727-34A0247, dated
January 2, 2019; Boeing Alert Service Bulletin 757-34A0611, Revision 1,
dated March 22, 2019; and Boeing Alert Service Bulletin 767-34A0828,
dated December 6, 2018. The service information describes procedures
for a general visual inspection of the AOA sensors for a certain part
number, and replacement of affected AOA sensors. These documents are
distinct since they apply to different airplane models.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishment of the actions
identified as ``RC'' (required for compliance) in the Accomplishment
Instructions of Boeing Alert Service Bulletin 727-34A0247, dated
January 2, 2019; Boeing Alert Service Bulletin 757-34A0611, Revision 1,
dated March 22, 2019; and Boeing Alert Service Bulletin 767-34A0828,
dated December 6, 2018; described previously, except as discussed under
``Differences Between this Proposed AD and the Service Information,''
and except for any differences identified as exceptions in the
regulatory text of this proposed AD.
    For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2019-0252.

Differences Between This Proposed AD and the Service Information

    Although Boeing Alert Service Bulletin 727-34A0247, dated January
2, 2019, recommends accomplishing the inspection within 2,750 flight
hours; Boeing Alert Service Bulletin 757-34A0611, Revision 1, dated
March 22, 2019, recommends accomplishing the inspection within 9,960
flight hours; and Boeing Alert Service Bulletin 767-34A0828, dated
December 6, 2018, recommends accomplishing the inspection within 3,470
flight hours, we have determined that this compliance time will not
ensure that the identified unsafe condition is addressed in a timely
manner. In developing an appropriate compliance time for this AD, we
considered the degree of urgency associated with addressing the subject
unsafe condition, the average utilization of the affected fleet, and
the time necessary to perform the modifications. In light of all of
these factors, we find the compliance times specified in the applicable
service information, or within 36 months after the effective date of
this AD, whichever occurs first, represents an appropriate interval of
time for affected airplanes to continue to operate without compromising
safety. This difference has been coordinated with the Boeing.

Costs of Compliance

    We estimate that this proposed AD affects 1,287 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                          Estimated Costs for Required Actions
--------------------------------------------------------------------------------------------------------------------------------------------------------
              Action                      Labor cost                 Parts cost                   Cost per product             Cost on U.S. operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection........................  1 work-hour x $85 per  $0............................  $85...........................  $109,395.
                                     hour = $85.
Replacement.......................  Up to 3 work-hours x   Up to $54,000.................  Up to $54,255.................  Up to $69,826,185.
                                     $85 per hour = Up to
                                     $255.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

The Boeing Company: Docket No. FAA-2019-0252; Product Identifier
2019-NM-048-AD.

(a) Comments Due Date

    The FAA must receive comments on this AD action by August 23,
2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company airplanes, identified in
paragraphs (c)(1) through (c)(3) of this AD, certificated in any
category.
    (1) Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F
series airplanes, as identified in Boeing Alert Service Bulletin
727-34A0247, dated January 2, 2019.
    (2) Model 757-200, -200PF, -200CB, and -300 series airplanes, as
identified in Boeing Alert Service Bulletin 757-34A0611, Revision 1,
dated March 22, 2019.
    (3) Model 767-200, -300, -300F, and -400ER series airplanes, as
identified in Boeing Alert Service Bulletin 767-34A0828, dated
December 6, 2018.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by reports of nuisance stick shaker
activation while the airplane accelerated to cruise speed at the top
of climb. This AD was also prompted by an investigation of those
reports that revealed that the angle of attack (AOA) (also known as
angle of airflow) sensor vanes could not prevent the build-up of
ice, causing the AOA sensor vanes to become immobilized, which
resulted in nuisance stick shaker activation. We are issuing this AD
to address ice build-up in the AOA sensor faceplate and vane, which
may immobilize the AOA sensor vanes, and could result in inaccurate
or unreliable AOA sensor data being transmitted to airplane systems
and consequent loss of controllability of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Within 36
months after the effective date of this AD or at the applicable
times specified in paragraph 1.E., ``Compliance,'' of Boeing Alert
Service Bulletin 727-34A0247, dated January 2, 2019; Boeing Alert
Service Bulletin 757-34A0611, Revision 1, dated March 22, 2019; or
Boeing Alert Service Bulletin 767-34A0828, dated December 6, 2018;
as applicable, whichever occurs first, do all applicable actions
identified as ``RC'' (required for compliance) in, and in accordance
with, the Accomplishment Instructions of Boeing Alert Service
Bulletin 727-34A0247, dated January 2, 2019; Boeing Alert Service
Bulletin 757-34A0611, Revision 1, dated March 22, 2019; or Boeing
Alert Service Bulletin 767-34A0828, dated December 6, 2018; as
applicable. All replacements of the affected AOA sensors must be
done before further flight.

(h) Exceptions to Service Information Specifications

    For purposes of determining compliance with the requirements of
this AD: Where Boeing Alert Service Bulletin 727-34A0247, dated
January 2, 2019; Boeing Alert Service Bulletin 757-34A0611, Revision
1, dated March 22, 2019; or Boeing Alert Service Bulletin 767-
34A0828, dated December 6, 2018; as applicable, uses the phrase
``the original issue date of this service bulletin,'' this AD
requires using ``the effective date of this AD.''

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles ACO Branch, FAA, has the authority
to approve AMOCs for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your
request to your principal inspector or local Flight Standards
District Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (j)(1) of this AD. Information
may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Los
Angeles ACO Branch, FAA, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of

paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(j) Related Information

    (1) For more information about this AD, contact Jeffrey W.
Palmer, Aerospace Engineer, Systems and Equipment Section, FAA, Los
Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-
4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110 SK57, Seal Beach, CA 90740
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on June 10, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-14502 Filed 7-8-19; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61004-61006]
[FR Doc No: 2012-24554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Request for Nominations for Voting Members on Public Advisory
Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Allergenic Products
Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue
and Gene Therapies Advisory Committee, and Transmissible Spongiform and
Encephalopathies Advisory Committee, Center for Biologics Evaluation
and Research. Nominations will be accepted for vacancies that will or
may occur through December 31, 2013.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.

DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.

ADDRESSES: All nominations for membership should be sent electronically
to<EMAIL_ADDRESS>or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member on a FDA
advisory committee can also be obtained by visiting FDA's Web site at
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For specific Committee questions,
contact the following persons listed in Table 1 of this document:

                                 Table 1
------------------------------------------------------------------------
                Contact person                         Committee
------------------------------------------------------------------------
Donald Jehn, Center for Biologics Evaluation   Allergenic Products
 and Research, Food and Drug Administration,    Advisory Committee.
 1401 Rockville Pike, HFM-71, Rockville, MD
 20852,<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Bryan Emery, Center for Biologics Evaluation   Blood Products Advisory
 and Research, Food and Drug Administration,    Committee and
 1401 Rockville Pike, HFM-71, Rockville, MD     Transmissible Spongiform
 20852,<PHONE_NUMBER>, email:                    Encephalopathies
<EMAIL_ADDRESS>                      Advisory Committee.
Gail Dapolito, Center for Biologics            Cellular, Tissue and Gene
 Evaluation and Research, Food and Drug         Therapies Advisory
 Administration, 1401 Rockville Pike, HFM-71,   Committee.
 Rockville, MD 20852,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations of voting members for vacancies
listed as follows:

                                 Table 2
------------------------------------------------------------------------
                                 Upcoming
 Committee expertise needed      vacancies      Approximate date needed
------------------------------------------------------------------------
Allergenic Products Advisory               3  September 1, 2013.
 Committee--individuals
 knowledgeable in clinical
 immunology/allergy.
Blood Products Advisory                    4  October 1, 2013.
 Committee--individuals
 knowledgeable in surgery/
 trauma, pediatric
 hematology/oncology,
 hematology, medical
 epidemiology.
Cellular, Tissue and Gene                  2  April 2, 2013.
 Therapies Advisory
 Committee--individuals
 knowledgeable in tissue
 engineering/regenerative
 medicine, orthopedic
 oncology.

Transmissible Spongiform                   2  February 1, 2013.
 Encephalopathies Advisory
 Committee--individuals
 knowledgeable in veterinary
 medicine, prion molecular
 biology.
------------------------------------------------------------------------

II. Functions

A. Allergenic Products Advisory Committee

    The Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of Food and Drugs of its findings regarding the
affirmation or revocation of biological product licenses, on the
safety, effectiveness, and labeling of the products, on clinical and
laboratory studies of such products, on amendments or revisions to
regulations governing the manufacture, testing and licensing of
allergenic biological products, and on the quality and relevance of
FDA's research programs which provide the scientific support for
regulating these agents.

B. Blood Products Committee

    The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which the Food and Drug Administration
has regulatory responsibility, and advises the Commissioner of Food and
Drugs of its findings regarding the safety, effectiveness, screening
and testing (to determine eligibility) of donors and labeling of the
products, on clinical and laboratory studies involving such products,
on the affirmation or revocation of biological product licenses, and on
the quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the
Committee recommends classification of devices subject to its review
into regulatory categories; recommends the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.

C. Cellular, Tissue and Gene Therapies Advisory Committee

    The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies and xenotransplantation products which
are intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in the reconstruction, repair or replacement of tissues for various
conditions. The Committee also considers the quality and relevance of
FDA's research program which provides scientific support for the
regulation of these products, and makes appropriate recommendations to
the Commissioner of Food and Drugs.

D. Transmissible Spongiform Encephalopathies Advisory Committee

    The Committee reviews and evaluates available scientific data
concerning the safety of products which may be at risk for transmission
of spongiform encephalopathies having an impact on the public health as
determined by the Commissioner of Food and Drugs. The Committee will
make recommendations to the Commissioner regarding the regulations of
such products.

III. Qualifications

A. Allergenic Products Advisory Committee

    Persons nominated for membership should be authorities
knowledgeable in the fields of allergy, immunology, pediatrics,
internal medicine, biochemistry, and related specialties. The
particular needs at this time for this committee are listed in section
I of this document. The term of office is up to 4 years, depending on
the appointment date.

B. Blood Products Advisory Committee

    Persons nominated for membership should be authorities
knowledgeable in the fields of clinical and administrative medicine,
hematology, immunology, blood banking, surgery, internal medicine,
biochemistry, engineering, biological and physical sciences,
biotechnology, computer technology, statistics, epidemiology,
sociology/ethics, and other related professions. The particular needs
at this time for this committee are listed in section I of this
document. The term of office is up to 4 years, depending on the
appointment date.

C. Cellular, Tissue and Gene Therapies Advisory Committee

    Persons nominated for membership should be authorities
knowledgeable in the fields of cellular therapies, tissue
transplantation, gene transfer therapies and xenotransplantation
(biostatistics, bioethics, hematology/oncology, human tissues and
transplantation, reproductive medicine, general medicine and various
medical specialties including surgery and oncology, immunology,
virology, molecular biology, cell biology, developmental biology, tumor
biology, biochemistry, rDNA technology, nuclear medicine, gene therapy,
infectious diseases, and cellular kinetics). The particular needs at
this time for this committee are listed in section I of this document.
The term of office is up to 4 years, depending on the appointment date.

D. Transmissible Spongiform Encephalopathies Advisory Committee

    Persons nominated for membership should be authorities
knowledgeable in the fields of clinical and administrative medicine,
hematology, virology, neurovirology, neurology, infectious diseases,
immunology, transfusion medicine, surgery, internal medicine,
biochemistry, biostatistics epidemiology, biological and physical
sciences, sociology/ethics, and other related professions.

IV. Nomination Procedures

    Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations must
include a current, complete resume or curriculum vitae for each
nominee, and their current business address and/or home address,
telephone number, and email address if available. Nominations must
specify the advisory committee(s) for which the nominee is recommended.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters related to
financial holdings, employment, and research grants and/or contracts to
permit evaluation of possible sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.

    Dated: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-24554 Filed 10-4-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Notices]
[Page 50628-50630]
[DOCID:fr27au08-52]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0454]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Contact Substances Notification System

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated

with the Food Contact Substances Notification System.

DATES:  Submit written or electronic comments on the collection of
information by October 27, 2008.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Food Contact Substances Notification System--21 CFR 170.101, 170.106,
and 171.1 (OMB Control Number 0910-0495)--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(h)) establishes a premarket notification process
for food contact substances. Section 409(h)(6) of the act defines a
``food contact substance'' as ``any substance intended for use as a
component of materials used in manufacturing, packing, packaging,
transporting, or holding food if such use is not intended to have any
technical effect in such food.'' Section 409(h)(3) of the act requires
that the notification process be used for authorizing the marketing of
food contact substances except when: (1) FDA determines that the
submission and premarket review of a food additive petition (FAP) under
section 409(b) of the act is necessary to provide adequate assurance of
safety or (2) FDA and the manufacturer or supplier agree that an FAP
should be submitted. Section 409(h)(1) of the act requires that a
notification include: (1) Information on the identity and the intended
use of the food contact substance and (2) the basis for the
manufacturer's or supplier's determination that the food contact
substance is safe under the intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101
and 170.106) specify the information that a notification must contain
and require that: (1) A food contact notification (FCN) include FDA
Form 3480 entitled ``Notification for New Use of a Food Contact
Substance'' and (2) a notification for a food contact substance
formulation include FDA Form 3479 entitled ``Notification for a Food
Contact Substance Formulation.'' These forms will serve to summarize
pertinent information in the notification. FDA believes that these
forms will facilitate both preparation and review of notifications
because the forms will serve to organize information necessary to
support the safety of the use of the food contact substance. The burden
of filling out the appropriate form has been included in the burden
estimate for the notification.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit in order to: (1) Establish
that the proposed use of an indirect food additive is safe and (2)
secure the publication of an indirect food additive regulation in parts
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations'' provides
assistance to manufacturers of food packaging in evaluating processes
for producing packaging from post-consumer recycled plastic. The
recommendations in the guidance address the process by which
manufacturers certify to FDA that their plastic products are safe for
food contact.
    Description of Respondents: Manufacturers of food contact
substances.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        No. of        Annual Frequency     Total Annual      Hours per
           21 CFR Section                       Form No.              Respondents       per Response         Responses       Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106\2\ (Category A)              FDA 3479                                    5                     1               5               2              10
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101\3,7\ (Category B)            FDA 3480                                    5                     1               5              25             125
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101\4,7\ (Category C)            FDA 3480                                    5                     2              10             120           1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101\5,7\ (Category D)            FDA 3480                                   33                     2              66             150           9,900
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.101\6,7\ (Category E)            FDA 3480                                   30                     1              30             150           4,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1 Indirect Food Additive         .............................               2                     2               2          10,995          21,990
 Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------

Guidance
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use of Recycled Plastics in Food     .............................              10                     1              10              25             250
 Packaging: Chemistry
 Considerations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                37,975
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of FDA Form 3479
  (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of FDA Form 3480.

    These estimates are based on FDA's experience with the food contact
substances notification system. Based on input from industry sources,
FDA estimates that approximately five respondents will submit one
notification annually for food contact substance formulations (Form FDA
3479), for a total of five responses. FDA estimates the reporting
burden to be 2.0 hours per response, for a total burden of 10 hours.
FDA also has included five expected duplicate submissions in the second
row of table 1 of this document. FDA expects that the burden for
preparing these notifications primarily will consist of the
manufacturer or supplier filling out FDA Form 3480, verifying that a
previous notification is effective and preparing necessary
documentation. Thus, FDA estimates that five respondents will submit
one such submission annually, for a total of five responses. FDA
estimates the reporting burden to be 25.0 hours per response, for a
total burden of 125 hours.
    Based on the submissions received, FDA identified three other tiers
of FCNs that represent escalating levels of burden required to collect
information (denoted as Categories C, D, and E in the third, fourth,
and fifth rows of table 1 of this document). FDA estimated the median
number of hours necessary for collecting information for each type of
notification within each of the three tiers based on input from
industry sources. FDA estimates that five respondents will submit two
Category C submissions annually, for a total of ten responses. FDA
estimates the reporting burden to be 120 hours per response, for a
total burden of 1,200 hours. FDA estimates that 33 respondents will
submit 2 Category D submissions annually, for a total of 66 responses.
FDA estimates the reporting burden to be 150 hours per response, for a
total burden of 9,900 hours. FDA estimates that 30 respondents will
submit 1 Category E submission annually, for a total of 30 responses.
FDA estimates the reporting burden to be 150 hours per response, for a
total burden of 4,500 hours.
    FDA estimates that two respondents will submit one indirect food
additive petition under Sec.  171.1, for a total of two responses. FDA
estimates the reporting burden to be 10,995 hours per response, for a
total burden of 21,990 hours.
    FDA estimates that 10 respondents will utilize the recommendations
in the guidance document entitled ``Use of Recycled Plastics in Food
Packaging: Chemistry Considerations,'' to develop the additional
information for one such submission annually, for a total of 10
responses. FDA estimates the reporting burden to be 25 hours per
response, for a total burden of 250 hours.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: August 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19843 Filed 8-26-08; 8:45 am]

BILLING CODE 4160-01-S


  SEQ CHAPTER \h \r 1 Reader’s Guide to Mecoprop-p (MCPP-p) Docket

EPA-HQ-OPP-2006-0943

Publication Date: October 24, 2007

	EPA has created this document to provide an organizational structure to
the Mecoprop-p Docket.  The Agency is providing the “Reader’s
Guide” to allow the reader to more easily access and navigate the
various items contained in the Mecoprop-p docket.

Docket Items 1 - 10. 	Preliminary Documents Presented During the Public
Comment Period.

These docket items include the preliminary risk assessments, its
supporting documents, and comments received during the 60-day public
comment period, which ended on June 25, 2007.

Docket Item 11.	Federal Register Notice: Mecoprop-p Reregistration
Eligibility Decision

This document formally and publicly announces the availability of the
mecoprop-p Reregistration Eligibility Decision (MCPP-p RED) on the
internet or at the EPA’s Office of Pesticides Program Docket Center.

Docket Item 12. 	Reader’s Guide to the Mecoprop-p Docket #
EPA-HQ-OPP-2006-0943

This document is designed to annotate the documents in support of the
MCPP-p RED in the docket.

Docket Item 13.	Reregistration Eligibility Decision for Mecoprop-p
(MCPP-p), August 2007.  Publication #EPA 738-R-07-009.

The MCPP-p RED includes summaries of the human health and ecological
risk assessments, identifies any potential risks of concern, and the
respective mitigation measures to address these risk concerns.

Docket Item 14.	MCPP-p: Response to Public Comments On HED Preliminary
Human Health Risk Assessment.  DP: 341284.  July 27, 2007.  (W. Phang et
al, HED)

This document is the Agency’s response to comments received on the
human health assessment received during the public comment period.

Docket Item 15.	MCPP-p (acid), MCPP-p DMAS, & MCPP-p potassium salt:
Revised HED Human Health Risk Assessment.  DP: 341965.  July 26, 2007
(W. Phang et al, HED)

This document addresses human health exposures and potential risks
resulting from the use of MCPP-p, and includes any appropriate revisions
based on received comments during the public comment period.

Docket Item 16.	MCPP-p: 2nd Revised Occupational and Residential
Exposure and Risk Assessment for the Reregistration Eligibility
Decision.  DP: D322766.  July 27, 2007.  (T. Dole, HED)

This document addresses occupational and residential exposures and
potential risks resulting from the use of MCPP-p, and includes any
appropriate revisions based on comments received during the public
comment period.

Docket Item 17.	Environmental Fate and Effects Division Response to
Public Comments to Final MCPP-p RED.  DP: D341274.  August 21, 2007 (C.
Hartless et al. EFED)

This document is the Agency’s response to comments on the ecological
assessment received during the public comment period.

Docket Item 18.	Environmental Fate and Effects Division Correction to
MCPP-p RED and Environmental Fate and Effects Science Chapter for MCPP-p
acid, MCPP-p DMAS, & MCPP-p potassium salt.  DP: D343135.  August 28,
2007.  (C. Hartless et al. EFED)

This document is the Agency’s ecological exposure and risk assessment,
identifying potential ecological risks resulting from the use of MCPP-p,
and includes the appropriate revisions based on comments received during
the public comment period.

Docket Item 19.	FQPA Drinking Water Assessment for Mecoprop (MCPP-p)

			DP: D322772.  June 26, 2007.  (J. Hetrick, EFED)

This document is the Agency’s MCPP-p drinking water assessment and
includes appropriate revisions based on comments received during the
public comment period.

Docket Item 20.	A Preliminary Evaluation of Mecoprop (MCPP-p) and
Dichlorprop (2,4-DP-p) Use and Potential Alternatives.  August 21, 2007.
 (B. Phillips and A. Lee, BEAD)

This document is an evaluation on the current uses of mecoprop-p
(MCPP-p) and dichlorprop-p
(2,4-DP-p)湡瑩⁳潰整瑮慩污整湲瑡癩敨扲捩摩
獥മ̍഍ഄ̍഍ഄऍ䍍偐瀭删慥敤鉲⁳畇摩൥ഀ഍䴉捥
灯潲⵰⁰敒摡牥玒䜠極敤

഍഍


[Federal Register: August 29, 2007 (Volume 72, Number 167)]
[Rules and Regulations]
[Page 49654-49660]
[DOCID:fr29au07-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0428; FRL-8138-6]

Flusilazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for
residues of flusilazole in or on soybean seed, soybean aspirated grain
fractions, and soybean oil. This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of
the pesticide on soybeans. This regulation establishes maximum
permissible levels for residues of flusilazole in these food
commodities. The tolerances expire and are revoked on December 31,
2010.

DATES: This regulation is effective August 29, 2007. Objections and
requests for hearings must be received on or before October 29, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0428. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may

also access a frequently updated electronic version of 40 CFR part 180
through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0428 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 29, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0428, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the fungicide
flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-
triazole), in or on soybean seed at 0.04 parts per million (ppm),
soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10
ppm. These tolerances expire and are revoked on December 31, 2010. EPA
will publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 of the FFDCA and the new safety standard to
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA
to establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is
a reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of the FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Flusilazole on Soybeans and FFDCA
Tolerances

    Australasian soybean rust (SBR) is a plant disease caused by 2
fungal species, Phakopsora pachyrhizi and P. meibomiae, and is spread
primarily by windborne spores that can be transported over long
distances. SBR models suggest that most of the soybean acreage in the
U.S. could be compromised by an SBR epidemic. In accordance with the
2002 Agricultural Bioterrorism Protection Act, SBR was identified by
the United Stated Department of Agriculture (USDA) as a select
biological agent with the potential to pose a severe threat to the
soybean industry and livestock production, in general. As such, USDA
has invested in extensive readiness and outreach activities among
soybean producers. EPA has authorized under FIFRA section 18 the use of
flusilazole on soybeans for control of Australasian Soybean Rust in
Minnesota and South Dakota. After having reviewed the states'
submissions, EPA concurs that emergency conditions exist for these
States.
    As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of flusilazole in or
on soybean seed, aspirated grain fractions, and oil. In doing so, EPA
considered the safety standard in section 408(b)(2) of the FFDCA, and
EPA decided that the necessary tolerances under section 408(l)(6) of
the FFDCA would be consistent with the safety standard and with FIFRA
section 18. Consistent with the need to move quickly on the emergency
exemption in order to address an urgent non-routine situation and to
ensure that the resulting food is safe and lawful, EPA is issuing these
tolerances without notice and opportunity for public comment as
provided in section 408(l)(6) of the FFDCA. Although these tolerances
expire and are revoked on December 31, 2010, under section 408(l)(5) of
the FFDCA, residues of the pesticide not in excess of the amounts
specified in the tolerances remaining in or on soybean seed, aspirated
grain fractions, and oil after that date will not be unlawful, provided
the pesticide is applied in a manner that was lawful under FIFRA, and
the residues do not exceed levels that were authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.

    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether flusilazole
meets EPA's registration requirements for use on soybean or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as the
basis for registration of flusilazole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for use of this pesticide on this crop under section 18 of FIFRA
by any State other than those following all provisions of EPA's
regulations implementing FIFRA section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
flusilazole, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
flusilazole and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for time-limited
tolerances for residues of flusilazole in or on soybean seed at 0.04
ppm, soybean aspirated grain fractions at 2.6 ppm, and soybean oil at
0.10 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
applied in order to protect infants and children, this additional
factor is applied to the RfD by dividing the RfD by such additional
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under
certain specific circumstances, MOE calculations will be used for the
carcinogenic risk assessment. In this non-linear approach, a ``point of
departure'' is identified below which carcinogenic effects are not
expected. The point of departure is typically a NOAEL based on an
endpoint related to cancer effects though it may be a different value
derived from the dose response curve. To estimate risk, a ratio of the
point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated.
    A summary of the toxicological endpoints for flusilazole used for
human risk assessment is discussed in Table 2.3 on page 15 of the human
health risk assessment found at http://www.regulations.gov Docket No.

EPA-HQ-OPP-2007-0428-0001.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. There are currently no
tolerances established for this chemical, and it is not registered in
the US. Risk assessments were conducted by EPA to assess dietary
exposures from flusilazole in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. EPA used the Dietary Exposure Evaluation Model
(DEEM\TM\) and data on individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) to estimate exposure to
the chemical for each commodity. This acute risk assessment used
conservative and high end assumptions to estimate acute exposure and
risk, as follows: It was assumed that flusilazole residues in soybean
commodities would be at proposed tolerance levels or higher; default
processing factors were applied to account for effects that may occur
on flusilazole residues from processing into soybean oil; an additional
factor was incorporated to account for potential residues of the
metabolite of flusilazole, which may occur in soybean commodities; and
it was assumed that 100% of the soybean crop grown in the US would be
treated. No refinements such as incorporating anticipated residue
values or percent of crop treated (PCT) assumptions were used. A high-
end estimate for contribution to dietary exposure from residues
occurring in drinking water, was incorporated directly into the dietary
assessment using the 30-year average annual concentration for surface
water generated by the Agency's computer simulation, the Pesticide Root
Zone/Exposure Analysis Modeling System (PRZM-EXAMS).
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment EPA used the DEEM\TM\ and data on individual food
consumption as reported by respondents in the USDA 1994-1996 and 1998
nationwide CSFII to estimate exposure to the chemical for each
commodity. The chronic risk assessment also used the same conservative
and high-end assumptions as described above in Unit IV.B.1.i., for
calculation of the acute exposure estimates and risk.
    iii. Cancer. The cancer risk assessment incorporated the same
dietary exposure estimates as used for the chronic assessment, and used
conservative and high-end assumptions to calculate cancer risk
estimates over a lifetime of exposure, as described above in Unit
IV.B.1.i.
    2. Dietary exposure from drinking water. Since this exemption is
the only use of a new pesticide in the US, there

are no residues in drinking water, and thus there are no monitoring
exposure data to use for a comprehensive dietary exposure analysis and
risk assessment for flusilazole in drinking water. Because of this, the
Agency calculated drinking water concentration estimates which may
occur from this use, by reliance on simulation or modeling taking into
account data on the physical characteristics of flusilazole.
    None of the models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health LOC.
    Based on available data, and for this section 18 use only, the
Agency determined that the residue of concern for drinking water is
flusilazole per se. Some surface and ground water contamination may
occur based on the proposed application rates and the environmental
fate properties of flusilazole, although mobility in soil is expected
to be low.
    Based on Tier II screening-level surface water modeling for
drinking water, the Agency estimated concentrations in surface water to
be used for acute, chronic non-cancer, and cancer exposure assessment.
Tier II surface water concentrations for parent flusilazole were
calculated using PRZM-EXAMS. PRZM/EXAMS incorporates an index reservoir
environment and includes a percent crop area factor as an adjustment to
account for the maximum percent crop coverage within a watershed or
drainage basin. EPA used the Screening Concentration Ground Water (SCI-
GROW2) model to estimate ground water concentrations. These results for
both surface and ground water are consistent with the fate and
transport properties of flusilazole.
    Modeled estimates of drinking water concentrations were
incorporated directly into the dietary assessments using the estimated
drinking water concentrations (EDWC) for surface water generated by the
PRZM-EXAMS model. For the acute assessment, the peak concentration of
1.81 parts per billion (ppb) was used to assess the contribution to
surface drinking water; for the chronic assessment, the annual mean
value of 0.92 ppb was used to assess the contribution to surface
drinking water. The EDWC for groundwater was estimated by SCI-GROW2 at
0.05 ppb. Since the EDWC estimated by SCI-GROW2 for groundwater was
lower, at 0.05 ppb, the higher, more conservative, surface water
estimate of 1.81 ppb was used for assessing contribution to dietary
exposures.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Flusilazole is not
registered for use on any sites that would result in residential
exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and`` other substances
that have a common mechanism of toxicity.''
    Flusilazole is a member of the triazole-containing class of
pesticides. Although triazole pesticides act similarly in plants
(fungi) by inhibiting ergosterol biosynthesis, there is not necessarily
a relationship between this pesticidal activity and their mechanism of
toxicity in mammals. Structural similarities do not constitute a common
mechanism of toxicity. Evidence is needed to establish that the
chemicals operate by the same, or essentially the same sequence of
major biochemical events (EPA, 2002). In triazoles a variable pattern
of toxicological responses is found. Some are hepatotoxic and
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some
induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the triazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that triazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the triazole pesticides. For information regarding EPA's
procedures for cumulating effects from substances found to have a
common mechanism of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative
.

    Flusilazole is a triazole-derived pesticide. This class of
compounds can form the common metabolites 1,2,4-triazole conjugates
(triazole alanine and triazole acetic acid). To support existing
tolerances and to establish new tolerances for triazole-derived
pesticides, EPA conducted a human health risk assessment for exposure
to 1,2,4-triazole, triazole alanine, and triazole acetic acid resulting
from the use of all current and pending uses of any triazole-derived
fungicide. The risk assessment is highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). In addition, on the
assessment involving the 1,2,4-triazole metabolites, the Agency
retained the additional 10X FQPA safety factor for the protection of
infants and children. The assessment includes evaluations of risks for
various subgroups, including those comprised of infants and children.
The Agency's complete risk assessment may be found at http://www.epa.gov/opprd001/factsheets/tetraHHRA.pdf
.

    In that risk assessment, EPA concluded that, based upon the
available information and on conservative estimates of hazard and
exposure, there are no human health risk issues associated with 1,2,4-
triazole or its metabolites that would preclude re-registration of the
triazole-derivative fungicides registered to date or conditional
registrations of the triazole-derivative fungicides that have been
proposed as of September 1, 2005, which included the use of flusilazole
on soybean.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
    2. Developmental and Reproductive toxicity studies. There are
several developmental and 2-generation reproduction studies in rats and
rabbits that provide evidence of increased susceptibility to in utero
and/or pre-, postnatal exposure to flusilazole.

Developmental effects such as cleft palate, resorption and skeletal
malformations were observed in rats. In rabbits, increased resorptions
were observed. In both species, these effects occurred either in the
absence of maternal toxicity and/or at a dose that caused only marginal
maternal toxicity (decreased food consumption, body weight gain). In a
multi-generation reproduction study in rats a decrease in pup viability
at birth and decreased post-natal survival were observed either in the
absence of maternal toxicity and/or at a dose that caused only marginal
maternal toxicity.
    3. Prenatal and postnatal sensitivity. The evidence of increased
susceptibility observed in rats and rabbits is off-set because EPA has
set the acute (0.02 milligrams/kilograms (mg/kg) and chronic (0.002 mg/
kg) RfDs below the dose at which these developmental effects were
observed, and these are therefore protective with respect to these
effects. Although NOAELs were not identified in some developmental and
2-generation reproduction studies, there are well established NOAELs in
most of the developmental and 2-generation reproduction studies, and
the RfDs are below these NOAELs. Because EPA has set the RfDs well
below the levels at which developmental effects are observed, the
increased susceptibility seen in these studies does not warrant
retaining the 10X FQPA safety factor (i.e., it is 1X).
    4. Conclusion. For the purpose of this emergency quarantine
exemption, EPA relied on studies reviewed by the European Union as well
as some preliminary internal study reviews. Therefore, the stated
toxicological endpoints are applicable for this emergency section 18
use only, since upon detailed review of the new and existing data, the
final conclusions may change. EPA determined that, in terms of hazard,
there are low concerns and no residual uncertainties with regard to
pre-and/or post-natal toxicity. EPA determined that the FQPA 10X safety
factor to protect infants and children should be removed (reduced to
1X) based on the following:
    i. The toxicity database for flusilazole is complete.
    ii.The dietary food exposure assessment utilizes proposed
tolerance-level or higher residues and 100% CT information for all
commodities. By using these screening-level assessments, acute and
chronic exposures/risks will not be underestimated.
    iii.The dietary drinking water assessment (Tier 2 estimates)
utilizes values generated by model and associated modeling parameters
which are designed to provide conservative, health-protective, high-end
estimates of water concentrations.
    iv.There are no residential uses of flusilazole.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs), which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http:/www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently, the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This approach provides a more realistic estimate of
exposure because actual body weights and water exposures are then added
to estimates and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. The
risk assessment for flusilazole used in this tolerance document uses
this approach of incorporating water exposure directly in to the
dietary exposure analysis.
    There are no registered or proposed uses of flusilazole, which
result in residential exposures, so the aggregate exposure assessment
required by FFDCA section 408(b)(2)(D)(vi) consists solely of dietary
(food + drinking water) exposures.
    Aggregate exposure risk assessments were conducted by incorporating
the drinking water concentrations directly into the dietary exposure
assessment for the acute and chronic aggregate exposures (food +
drinking water). These aggregate exposures do not exceed the Agency's
LOC since they were less than 100% of the acute and chronic population
adjusted doses (PADs).
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and
drinking water to flusilazole is estimated at 0.000326 mg/kg/day, and
occupies 1.6% of the aPAD for females 13-49 years, the population
subgroup of concern. There were no acute toxicity concerns for other
population subgroups noted, based upon the available toxicology
studies, and therefore, no acute toxicology endpoints assigned.
Therefore, EPA does not expect aggregate dietary exposure for this
population subgroup of concern to exceed the LOC of 100% of the aPAD.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flusilazole from food and water will utilize 8.1% of the cPAD for the
U.S. population, 21% of the cPAD for All Infants < 1 year old (the most
highly exposed subpopulation), and 17% of the cPAD for Children 1-2
years old, and Children 3-5 years old (both subgroups). Flusilazole is
unregistered, and therefore there are no residential uses or exposures.
EPA does not expect the aggregate exposure to exceed 100% of the cPAD,
as shown in the following Table of this unit:

        Aggregate Risk Assessment for Chronic (Non-Cancer) Dietary (Food + Water) Exposure to Flusilazole
----------------------------------------------------------------------------------------------------------------
                   Population Subgroup                     Dietary exposure (mg/kg/day)      % cPAD utilized
----------------------------------------------------------------------------------------------------------------
General U.S. Population..................................                      0.000162                      8.1
----------------------------------------------------------------------------------------------------------------
All Infants (<  1 year old)...............................                      0.000429                       21
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old...................................                      0.000334                       17
----------------------------------------------------------------------------------------------------------------

Children 3-5 years old...................................                      0.000338                       17
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old..................................                      0.000243                       12
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old....................................                      0.000161                      8.0
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old...................................                      0.000143                      6.7
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old.....................................                      0.000110                      5.5
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old                                                        0.000128                      6.4
----------------------------------------------------------------------------------------------------------------

    3. Short-term and intermediate risks. Short-term and intermediate
aggregate exposures take into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Flusilazole is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which were previously addressed.
    4. Aggregate cancer risk for U.S. population. In its cancer
analysis, EPA assumed 100% of the soybean crop in the US would be
treated with flusilazole. EPA used the DEEM 7.81 default processing
factors to estimate residues that might occur in processed commodities
(i.e. soybean oil) and assumed that flusilazole residues in or on
soybean commodities would be equal to the proposed tolerance levels.
Drinking water was incorporated directly into the dietary assessment
using the 30-year average annual concentration for surface water
generated by the PRZM-EXAMS model as a high-end estimate. The resulting
cancer risk estimate for the general U.S. population (4.5 x
10-\7\) was less than EPA's LOC (generally 1 x
10-\6\).
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to flusilazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (gas chromatography/nitrogen-
phosphorus detector; and gas chromatography/mass-selective detector)
are available to enforce the tolerance expression. The methods may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits
(MRLs) for the residues of flusilazole on soybean commodities.
Therefore, there are no international harmonization concerns at this
time.

VI. Conclusion

    Therefore, the tolerances are established for residues of
flusilazole, (1-[[bis(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-
triazole), in or on soybean seed at 0.04 parts per million (ppm),
soybean aspirated grain fractions at 2.6 ppm, and soybean oil at 0.10
ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000) do not apply to this rule. In addition, This rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides

that before a rule may take effect, the agency promulgating the rule
must submit a rule report to each House of the Congress and to the
Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 22, 2007.
Martha Monell,
Acting Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

0
2. Section 180.630 is added to read as follows:

Sec.  180.630   Flusilazole; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the fungicide, flusilazole, (1-[[bis(4-
fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole) in connection with
use of the pesticide under Section 18 emergency exemptions granted by
EPA. The tolerances expire and are revoked on the dates specified in
the following table.

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Soybean, aspirated grain fractions                2.6         12/31/2010
Soybean, seed.....................               0.04         12/31/2010
Soybean, oil......................               0.10         12/31/2010
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]
[FR Doc. E7-17110 Filed 8-28-07; 8:45 am]

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