[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44645-44646]
[FR Doc No: 2011-18802]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64934; File No. SR-FINRA-2011-031]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Proposed Rule Change To Amend
FINRA Rule 9251 to Explicitly Protect From Discovery Those Documents
That Federal Law Prohibits FINRA From Disclosing

 July 20, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 8, 2011, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by FINRA. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to amend FINRA Rule 9251 to explicitly protect
from discovery those documents that federal law prohibits FINRA from
disclosing.
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA and at
the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    FINRA Rule 9251 delineates the types of documents that FINRA's
Department of Enforcement (``Enforcement'') and Department of Market
Regulation (``Market Regulation'') must produce to respondents during
the discovery phase of a disciplinary proceeding. The rule also
explicitly shields certain types of documents from production. For
example, Enforcement and Market Regulation may withhold documents that
are protected by attorney-client privilege or constitute attorney work
product.\3\ The rule allows additional types of documents to be
withheld where a hearing officer determines that they are irrelevant to
the proceeding or for other good cause.\4\ The rule, moreover, contains
procedural safeguards. For example, a hearing officer may privately
review and determine the appropriate status of a withheld document.\5\
The rule does not, however, explicitly shield from discovery documents
that federal law prohibits FINRA from disclosing. To help ensure both
an efficient discovery process and compliance with federal law, the
proposed rule change clarifies that Enforcement and Market Regulation
shall withhold such documents from respondents during a disciplinary
proceeding. Further, the proposed rule change precludes a hearing
officer from requiring Enforcement or Market Regulation to either
produce or reveal information about the existence of a document if
federal law prohibits such disclosure.
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    \3\ FINRA Rule 9251(b)(1)(A).
    \4\ FINRA Rule 9251(b)(1)(D).
    \5\ FINRA Rule 9251(c).
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    The proposed rule change would amend FINRA Rule 9251 to explicitly
protect from discovery those documents that federal law prohibits FINRA
from disclosing. Currently, when Enforcement and Market Regulation
possess a document that federal law prohibits them from disclosing,
they must affirmatively seek a hearing officer determination that they
can withhold it on the grounds of a lack of relevancy or for other good
cause. The proposed rule change would increase efficiency by avoiding
the need for the parties to brief, and hearing officers to resolve,
unnecessary ``good cause'' motions regarding documents that FINRA
cannot legally produce during disciplinary proceedings. The procedural
safeguard discussed above would apply to this category of withheld
documents.
    FINRA will announce the effective date of the proposed rule change
in a Regulatory Notice to be published no later than 60 days following
Commission approval. The effective date will be 30 days following

publication of the Regulatory Notice announcing Commission approval.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with
Section 15A(b)(6) of the Act,\6\ which requires, among other things,
that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposal also is consistent
with Section 15A(b)(7) of the Act,\7\ which provides that FINRA members
and associated persons must be appropriately disciplined for violations
of any provisions of the Act or FINRA rules. FINRA believes that the
proposed rule change is consistent with these purposes because it
promotes a fair and efficient disciplinary process by avoiding the need
for unnecessary ``good cause'' motions regarding documents that federal
law prohibits FINRA from producing.
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    \6\ 15 U.S.C. 78o-3(b)(6).
    \7\ 15 U.S.C. 78o-3(b)(7).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-031 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2011-031. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of FINRA.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-FINRA-2011-031
and should be submitted on or before August 16, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-18802 Filed 7-25-11; 8:45 am]
BILLING CODE 8011-01-P


Draft Panel Member List for the Federal Insecticide, Fungicide and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to Consider and Review "Integrated Approaches to Testing and Assessment Strategies: Use of New Computational and Molecular Tools"

                                May 24-26, 2011

EPA-HQ-OPP-2011-0284			OPP Docket Tel:<PHONE_NUMBER>

FIFRA SAP Chair

Kenneth Portier, Ph.D.
Program Director, Statistics
American Cancer Society
National Home Office
Atlanta, GA

Designated Federal Official

Fred Jenkins, Jr., Ph.D.
US Environmental Protection Agency
Office of Science Coordination & Policy
FIFRA Scientific Advisory Panel
EPA East Building, MC 7201M
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Tel:<PHONE_NUMBER>, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>
FIFRA Scientific Advisory Panel Members

Janice Chambers, Ph.D., DABT, ATS
William L. Giles Distinguished Professor
Director
Center for Environmental Health Sciences
College of Veterinary Medicine
Mississippi State University
Mississippi State, MS

Stephen Klaine, Ph.D.
Professor
Department of Biological Sciences
Director Clemson Institute of Environmental Toxicology
Clemson University, SC
Clemson, SC

Carey Pope, Ph.D.
Professor; Head & Sitlington Chair of Toxicology
Department of Physiological Sciences
Center for Veterinary Health Sciences
Oklahoma State University College of Veterinary Medicine
Stillwater, OK

Martha Sandy, Ph.D.
Senior Toxicologist and Chief
Office of Environmental Health Hazard Assessment
Reproductive and Cancer Hazard Assessment Branch
California Environmental Protection Agency
Oakland, CA

Daniel Schlenk, Ph.D.
Professor of Aquatic Ecotoxicology & Environmental Toxicology
Department of Environmental Sciences
University of California, Riverside
Riverside, CA

FQPA Science Review Board Members

Mitchell Cheeseman, Ph.D.
Acting Director
Office of Food Additive Safety
US Food and Drug Administration
College Park, MD

Robert Denver, Ph.D.
Professor
Departments of Molecular, Cellular & Developmental Biology and
Ecology & Evolutionary Biology
University of Michigan
Ann Arbor, MI

Charles Eldridge, Ph.D.
Professor of Physiology & Pharmacology
School of Medicine
Wake Forest University
Winston Salem, NC

J. David Furlow, Ph.D.
Associate Professor
Section of Neurobiology, Physiology and Behavior
University of California, Davis
Davis, CA

Roberta Grant, Ph.D.
Toxicology Division
Chief Engineer's Office
Texas Commission on Environmental Quality
Austin, TX

Richard Greenwood, Ph.D.
Professor Emeritus of Environmental Science
Head of School of Biological Sciences
School of Biological Sciences
University of Portsmouth
Portsmouth, UK

William Hayton, Ph.D.
Professor Emeritus
Division of Environment Health Science
College of Pharmacy, School of Medicine and Public Health
Ohio State University
553 Klamath Drive
La Conner, WA

Nelson Horseman, Ph.D.
Professor
Departments of Molecular and Cellular Physiology
University of Cincinnati
Cincinnati, OH

David Jacobson-Kram, Ph.D.
Assoc. Dir. of Pharmacology and Toxicology
Center for Drug Evaluation and Research
US Food and Drug Administration
Silver Spring, MD

Teresa Leavens, Ph.D.
Research Assistant Professor
Department of Population Health and Pathology
College of Veterinary Medicine
North Carolina State University
Raleigh, NC

Bette Meek, Ph.D.
Associate Director - Chemical Risk Assessment
McLaughlin Institute for Population Health Risk Assessment
University of Ottawa
Ottawa, Canada

 Reynaldo Patino, Ph.D.
Research Scientist/Professor
U.S. Geological Survey
Texas Tech University
Texas Cooperative Fish and Wildlife Research Unit
Lubbock, TX

Terry Schultz, Ph.D.
Professor Emeritus
Department of Comparative Medicine
College of Veterinary Medicine
University of Tennessee
Knoxville, TN

Geoffrey Scott, Ph.D.
Director
NOAA, National Center for Ocean Science
Center for Coastal Environmental Health & Biomolecular Research
Charleston, SC


[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41291-41292]
[FR Doc No: 2014-16492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0031]

Draft Informed Consent Information Sheet: Guidance for
Institutional Review Boards, Clinical Investigators, and Sponsors;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Informed Consent
Information Sheet: Guidance for IRBs, Clinical Investigators, and
Sponsors.'' The draft guidance announced in this notice is intended to
assist institutional review boards (IRBs), clinical investigators, and
sponsors involved in clinical investigations of FDA-regulated products
in carrying out their responsibilities related to informed consent. The
draft guidance provides the Agency's recommendations and requirements
for informed consent to assure the protection of the rights and welfare
of human subjects in clinical investigations.

DATES: Although comments on any guidance can be submitted at any time
(see 21 CFR 10.115(g)(5)), to ensure that the Agency considers a
comment on this draft guidance before it begins work on the final
version of the guidance, electronic or written comments on the draft
guidance should be submitted by September 15, 2014.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or<PHONE_NUMBER>); or the Office of Communication, Outreach
and Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002 (1-800-835-4709 or<PHONE_NUMBER>); or the
Division of Industry and Consumer Education, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4622, Silver Spring, MD 20993 (1-800-638-2041 or
301-796-7100). Send one self-addressed adhesive label to assist the
office in processing your requests.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave,
Building 32, Silver Spring, MD 20993<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled:
``Informed Consent Information Sheet: Guidance for IRBs, Clinical
Investigators, and Sponsors.'' This draft guidance is intended to
assist IRBs, clinical investigators, and sponsors involved in clinical
investigations of FDA-regulated products in carrying out their
responsibilities related to informed consent under 21 CFR part 50 by
providing recommendations regarding the informed consent process, the
elements of informed consent, and the documentation of informed consent
to assure the protection of the rights and welfare of human subjects in
clinical investigations. When finalized, this guidance will supersede
the following Information Sheets: ``A Guide to Informed Consent'' and
``Frequently Asked Questions'' (only the sections entitled ``Informed
Consent Process'' and ``Informed Consent Document Content'') (September
1998, Office of Health Affairs, Food and Drug Administration). To
enhance human subject protection and reduce regulatory burden, the
Department of Health and Human Services (HHS), Office for Human
Research Protections (OHRP) and FDA have been actively working to
harmonize the Agencies' regulatory requirements and guidance for human
subject research. This draft guidance document was developed as a part
of these efforts.
    In addition, FDA acknowledges that HHS announced in 2011 that the
Federal Government is contemplating various ways of enhancing the
regulations overseeing research on human subjects. Before developing
proposed changes to the regulations--which have been in place since
1991 and are often referred to as the Common Rule--the Government
issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking the
public's input on an array of issues related to the ethics, safety, and
oversight of human research. The changes under consideration can be
found in the July 26, 2011, issue of the Federal Register in an ANPRM
entitled ``Human Subjects Research Protections: Enhancing Protections
for Research Subjects and Reducing Burden, Delay, and Ambiguity for
Investigators'' (available at www.hhs.gov/ohrp/humansubjects/anprm2011page.html). FDA issues this draft guidance while the Agencies
continue to explore potential changes to the Common Rule. To the extent
that issues presented in this draft guidance intersect with the Common
Rule, FDA plans to coordinate with other relevant Federal Agencies to
facilitate consistency across policies.
    FDA is issuing this as a draft guidance because the Information
Sheet entitled: ``A Guide to Informed Consent'' has been substantially
revised due to changes in regulation/regulatory policy and in response
to numerous questions about informed consent from subjects, subject
advocates, and the research community. For example, the draft guidance
includes a more detailed discussion of informed consent for non-English
speaking subjects. In addition, new sections address the new element of
informed consent for applicable clinical trials and discuss informed
consent issues related to consent capacity, children as subjects,
review of patient records, subjects with low literacy or numeracy,
subjects participating in more than one clinical trial, and study
suspension/termination. The draft guidance also explains the
responsibilities of the IRB, investigator, sponsor, and FDA related to
the development and review of informed consent documents.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collections provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information referenced in this guidance that are related
to IRB recordkeeping requirements under 21 CFR 56.115, which include
the requirements for records related to informed consent, have been
approved under OMB control number 0910-0130;

the collections of information related to the elements of informed
consent under 21 CFR 50.25, the documentation of informed consent under
21 CFR 50.27, IRB written notification to approve or disapprove
research under 21 CFR 56.109(e), and IRB continuing review under 21 CFR
56.109(f) have been approved under OMB control number 0910-0755; the
collection of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; and the collections of information in 21
CFR part 812 have been approved under OMB control number 0910-0078.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm.

    Dated: July 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16492 Filed 7-14-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Proposed Rules]
[Page 66087-66089]
[DOCID:fr27no07-37]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-0248; Directorate Identifier 2007-CE-084-AD]
RIN 2120-AA64

Airworthiness Directives; British Aerospace Aircraft Group,
Scottish Division, Model Beagle B.121 Series 1, 2, 3 Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    The Type Certificate Holder (TCH) has received several reports
of failed Rudder torque tube assemblies. The torque tube assemblies
are subject to repetitive inspection in accordance Airworthiness
Directive 2060 PRE 80. The recent failures occurred in service after
the inspections required by AD 2060 PRE 80 had been performed. In
the event of such failures, loss of directional control through both
the Rudder and Nosewheel Steering may occur. The TCH has also
received reports of loose rivets attaching the inboard Anchor
Assembly to the Starboard Torque Tube.

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 27,
2007.

ADDRESSES: You may send comments 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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Taylor Martin, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments

to an address listed under the ADDRESSES section. Include ``Docket No.
FAA-2007-****; Directorate Identifier 2007-CE-084-AD'' at the beginning
of your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of this
proposed AD. We will consider all comments received by the closing date
and may amend this proposed AD 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

    The United Kingdom Civil Aviation Authority, which is the aviation
authority for United Kingdom, has issued AD No: G-2005-0030, dated
October 12, 2005 (referred to after this as ``the MCAI''), to correct
an unsafe condition for the specified products. The MCAI states:

    The Type Certificate Holder (TCH) has received several reports
of failed Rudder torque tube assemblies. The torque tube assemblies
are subject to repetitive inspection in accordance Airworthiness
Directive 2060 PRE 80. The recent failures occurred in service after
the inspections required by AD 2060 PRE 80 had been performed. In
the event of such failures, loss of directional control through both
the Rudder and Nosewheel Steering may occur. The TCH has also
received reports of loose rivets attaching the inboard Anchor
Assembly to the Starboard Torque Tube.

    The MCAI requires the inspection of the rudder torque tube
assemblies and hubs for cracking and loose rivets with conditional
correction or replacement following de Havilland Support Limited
Service Bulletin B121/65, Issue 2, dated August 10, 2005.
    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    De Havilland Support Limited has issued Service Bulletin No. B121/
65, Issue 2, dated August 10, 2005. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1 product of U.S. registry. We also estimate that it
would take about 1 work-hour per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $80, or $80 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 12 work-hours and require parts costing $10,000 for a cost
of $10,960 per product.

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 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 this 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); 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 regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

British Aerospace (Scotland): Docket No. FAA-2007-0248; Directorate
Identifier 2007-CE-084-AD.

Comments Due Date

    (a) We must receive comments by December 27, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Beagle B.121 Series 1, 2, 3 airplanes,
all serial numbers, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    The Type Certificate Holder (TCH) has received several reports
of failed Rudder torque tube assemblies. The torque tube assemblies
are subject to repetitive inspection in accordance Airworthiness
Directive 2060 PRE 80. The recent failures occurred in service after
the inspections required by AD 2060 PRE 80 had been performed. In
the event of such failures, loss of directional control through both
the Rudder and Nosewheel Steering may occur. The TCH has also
received reports of loose rivets attaching the inboard Anchor
Assembly to the Starboard Torque Tube.

The MCAI requires the inspection of the rudder torque tube
assemblies and hubs for cracking and loose rivets with conditional
correction or replacement in accordance with de Havilland Support
Limited Service Bulletin B121/65, Issue 2, dated August 10, 2005.

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Within 100 hours time-in-service (TIS) after the effective
date of this AD and thereafter at intervals not to exceed 100 hours
TIS, inspect the Rudder Torque Tube Assemblies following de
Havilland Support Limited Service Bulletin B121/65, Issue 2, dated
August 10, 2005.
    (2) Before further flight, replace any cracked Rudder Torque
Tube Assemblies and correct any loose rivets in the Rudder Torque
Tube Assemblies that are found in the inspections required in
paragraph (f)(1) of this AD, following de Havilland Support Limited
Service Bulletin B121/65, Issue 2, dated August 10, 2005.
    (3) After the effective date of this AD, used rudder torque
assemblies held as spares for British Aerospace Aircraft Group,
Scottish Division, Model Beagle B.121 Series 1, 2, 3 airplanes must
be inspected following de Havilland Support Limited Service Bulletin
B121/65, Issue 2, dated August 10, 2005, and found free of cracks
prior to installation.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Taylor Martin, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI United Kingdom Civil Aviation Authority AD No:
G-2005-0030, dated October 12, 2005; and de Havilland Support
Limited Service Bulletin B121/65, Issue 2, dated August 10, 2005,
for related information.

    Issued in Kansas City, Missouri, on November 20, 2007.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
 [FR Doc. E7-23025 Filed 11-26-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 64 (Monday, April 4, 2022)]
[Rules and Regulations]
[Pages 19367-19369]
[FR Doc No: 2022-06959]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 87, No. 64 / Monday, April 4, 2022 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1170; Project Identifier MCAI-2020-01572-G;
Amendment 39-21970; AD 2022-06-04]
RIN 2120-AA64

Airworthiness Directives; Schempp-Hirth Flugzeugbau GmbH Gliders

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Schempp-Hirth Flugzeugbau GmbH Model Janus, Mini-Nimbus HS-7,
Nimbus-2, and Standard Cirrus gliders. This AD was prompted by
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as a disconnected pendulum elevator. This AD requires
installing colored markings and revising the existing aircraft flight
manual (FM) and service manual (SM). The FAA is issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective May 9, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 9, 2022.

ADDRESSES: For service information identified in this final rule,
contact Schempp-Hirth Flugzeugbau GmbH, Krebenstrasse 25, 73230
Kirchheim/Teck, Germany; phone: +49 7021 7298-0; fax: +49 7021 7298-
199; email: hirth.com">[email protected]hirth.com; website: https://www.schempp-
hirth.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-1170.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1170; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aviation Safety
Engineer, General Aviation & Rotorcraft Section, International
Validation Branch, FAA, 901 Locust, Room 301, Kansas City, MO 64106;
phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain serial-numbered
Schempp-Hirth Flugzeugbau GmbH Model Janus, Mini-Nimbus HS-7, Nimbus-2,
and Standard Cirrus gliders. The NPRM published in the Federal Register
on January 3, 2022 (87 FR 55). The NPRM was prompted by MCAI originated
by the European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Union. EASA
issued AD 2020-0260, dated November 26, 2020 (referred to after this as
``the MCAI''), to address an unsafe condition on certain serial
numbered Schempp-Hirth Flugzeugbau GmbH Model Janus, Mini-Nimbus HS 7,
Nimbus-2, Standard Cirrus, Standard Cirrus B, Standard Cirrus CS 11-
75L, and Nimbus-2M gliders. The MCAI states:

    During an aero tow of a Standard Cirrus, the pendulum elevator
disconnected. The technical investigation concluded that the
elevator attachment was not properly locked. Due to similarity of
design, this kind of event could also occur on other Schempp-Hirth
sailplanes, including Nimbus-2M powered sailplanes.
    This condition, if not corrected, could lead to failure of the
elevator connection and loss of control of the (powered) sailplane.
    To address this potential unsafe condition, Schempp-Hirth
published the [technical note] TN, providing instructions to install
an optical indicator and to update the Aircraft Flight Manual (AFM).
    For the reasons described above, this [EASA] AD requires
installation of an optical indicator and amendment of the AFM.

    You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
1170.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on these
products. This AD is adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Schempp-Hirth Flugzeugbau GmbH Technical Note No.
278-40/286-36/295-33/328-14/798-4, Revision 1, dated November 12, 2020
(issued as one document). The service information specifies procedures
for installing colored markings to the top of the elevator on both
sides of the locking mechanism and revising the existing aircraft FM
and SM. 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.

Differences Between This AD and the MCAI

    The MCAI applies to Schempp-Hirth Flugzeugbau GmbH Model Standard

Cirrus B, Standard Cirrus CS 11-75L, and Nimbus-2M gliders, and this AD
does not because these models do not have an FAA type certificate.

Costs of Compliance

    The FAA estimates that this AD affects 87 gliders of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Install markings......................  1 work-hour x $85 per                $10             $95          $8,265
                                         hour = $85.
Revise FM and SM......................  1 work-hour x $85 per                  0              85           7,395
                                         hour = $85.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify this AD:

    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2022-06-04 Schempp-Hirth Flugzeugbau GmbH: Amendment 39-21970;
Docket No. FAA-2021-1170; Project Identifier MCAI-2020-01572-G.

(a) Effective Date

    This airworthiness directive (AD) is effective May 9, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Schempp-Hirth Flugzeugbau GmbH Model Janus,
Mini-Nimbus HS-7, Nimbus-2, and Standard Cirrus gliders, with a
serial number listed in Schempp-Hirth Flugzeugbau GmbH Technical
Note No. 278-40/286-36/295-33/328-14/798-4, Revision 1, dated
November 12, 2020 (issued as one document), certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2700, Flight Control
System.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a disconnected
pendulum elevator. The FAA is issuing this AD to prevent an
improperly locked elevator attachment. The unsafe condition, if not
addressed, could result in failure of the elevator connection and
loss of control of the glider.

(f) Compliance

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

(g) Required Actions

    Within 90 days after the effective date of this AD, do the
following actions concurrently.
    (1) Install colored markings on the elevator in accordance with
Action 1 in Schempp-Hirth Flugzeugbau GmbH Technical Note No. 278-
40/286-36/295-33/328-14/798-4, Revision 1, dated November 12, 2020
(issued as one document).
    (2) Revise the existing aircraft flight manual (FM) and service
manual (SM) for your glider by replacing the pages specified in
Action 2 in Schempp-Hirth Flugzeugbau GmbH Technical Note No. 278-
40/286-36/295-33/328-14/798-4, Revision 1, dated November 12, 2020
(issued as one document), as applicable to your glider, with the
revised pages for the manual applicable to your glider dated June
2020.
    (3) The action required by paragraph (g)(2) of this AD may be
performed by the owner/operator (pilot) holding at least a private
pilot certificate and must be entered into the aircraft records
showing compliance with this AD in accordance with 14 CFR 43.9(a)(1)
through (4) and 14 CFR 91.417(a)(2)(v). The record must be
maintained as required by 14 CFR 91.417.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation 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 International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD and email to: [email protected].
    (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.

(i) Related Information

    (1) For more information about this AD, contact Jim Rutherford,
Aviation Safety Engineer, General Aviation & Rotorcraft Section,
International Validation Branch, FAA, 901 Locust, Room 301, Kansas
City, MO 64106; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2020-0260, dated November 26, 2020, for more information.

You may examine the EASA AD in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-1170.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Schempp-Hirth Flugzeugbau GmbH Technical Note No. 278-40/
286-36/295-33/328-14/798-4, Revision 1, dated November 12, 2020
(issued as one document).
    Note 1 to paragraph (j)(2)(i): This service information contains
German to English translation. EASA used the English translation in
referencing the document from Schempp-Hirth Flugzeugbau GmbH. For
enforceability purposes, the FAA will cite references to the service
information in English as it appears on the document.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Schempp-Hirth Flugzeugbau GmbH, Krebenstrasse 25, 73230 Kirchheim/
Teck, Germany; phone: +49 7021 7298-0; fax: +49 7021 7298-199;
email: hirth.com">[email protected]hirth.com; website: https://www.schempp-
hirth.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 10, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-06959 Filed 4-1-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 119 (Friday, June 19, 2020)]
[Notices]
[Pages 37119-37120]
[FR Doc No: 2020-13411]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Wednesday, June 24, 2020.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS:  This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: 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.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    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), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topic:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: June 17, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-13411 Filed 6-17-20; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Rules and Regulations]
[Pages 7712-7719]
[FR Doc No: 2011-3110]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0217; FRL-8858-3]

Clothianidin; Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for
residues of clothianidin in or on rice, seed. Valent U.S.A. Corporation
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA). The tolerances expire on June 23, 2012.

DATES: This regulation is effective February 11, 2011. Objections and
requests for hearings must be received on or before April 12, 2011, 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-2010-0217. All documents in the
docket are listed in the docket index available at http://www.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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Marianne Lewis, 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 get electronic access to other related information?

    In addition to accessing electronically available documents at
http://www.regulations.gov, you may access this Federal Register
document electronically through EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's e-CFR cite at
http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2010-0217 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 12, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0217, 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 Facility'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. Petitioned-for Tolerances

    In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 0G7682)
by Valent U.S.A Corporation, P.O. Box 8025 Walnut Creek, CA 94596. The
petition requested that 40 CFR 180.586 be amended by establishing
tolerances for residues of the insecticide clothianidin, (E)-1-(2-
chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on
rice, seed at 0.01 parts per million (ppm). That notice referenced a
summary of the petition prepared by Valent U.S.A. Corporation, the
registrant, which is available to the public in the docket, http://www.regulations.gov. One comment was received endorsing the
registration of this seed treatment.
    Valent has requested an experimental use permit and this tolerance
to determine the effectiveness of clothianidin as a rice, seed
treatment to control rice weevil and grape colaspis. This tolerance
will expire on June 23, 2012.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of 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 and to
make a determination on aggregate exposure for clothianidin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with clothianidin
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    EPA considered the toxicity of clothianidin as well as several
metabolites and degradates in conducting this risk assessment.
Metabolites/degradates of concern in plants include parent and TMG for
leafy and root and tuber vegetables; parent-only for other crops; and
parent, TZNG and MNG for rotational crops. For livestock commodities,
the metabolites/degradates of concern include: parent and TZU, TZG,
TZNG and ATMG-pyruvate for ruminants; and parent and TZU, TZG, TZNG,
and ATG-acetate for poultry. Acute toxicity and genotoxicity data are
available for several metabolites/degradates of clothianidin. Given
that the points of departure used for risk assessment are well below
the LD50 levels observed in the acute toxicology studies and
that clothianidin

and its metabolites/degradates of toxicological concern are similar in
structure, EPA is assuming that these compounds are toxicologically
equivalent to clothianidin with respect to the endpoints being used for
risk assessment.
    Clothianidin and its metabolites and degradates have relatively low
acute toxicity via oral, dermal and inhalation routes of exposure;
however, acute oral administration of clothianidin in mouse and the TMG
metabolite in rat showed evidence of increased relative toxicity. There
is no evidence of dermal sensitization or eye irritation with the
exception of the clothianidin-triazan intermediate, which is a dermal
sensitizer. The available data indicate that there are no consistent
target organs in mammals; however, some effects noted in the liver,
hematopoietic system and kidney are similar to effects from other
neonicotinoid insecticides.
    In subchronic oral studies, the dog seemed to be more sensitive to
clothianidin than the rat. In addition to decreases in body weight and
body weight gains observed in both animals, dogs also displayed
decreased white blood cells, albumin and total protein, as well as some
anemia. Long-term dietary administration of clothianidin did not result
in a wider spectrum of effects in the dog; in contrast, the chronic
feeding studies in rats showed additional effects in the liver, ovaries
and kidneys. In the mouse chronic oral study, increases in vocalization
and decreases in body weight and body weight gain were noted.
    Based on the lack of significant tumor increases in two adequate
rodent carcinogenicity studies, EPA has classified clothianidin as
``not likely to be carcinogenic to humans.'' A bone marrow micronucleus
assay in mice showed that clothianidin is neither clastogenic nor
aneugenic up to a toxic oral dose. Additionally, a study on the livers
of Wistar male mice showed no induction of unscheduled DNA sysnthesis
up to the limit dose; therefore, mutagenicity is not of concern.
    Clinical signs of neurotoxicity were exhibited in both rats
(decreased arousal, motor activity and locomotor activity) and mice
(decreased spontaneous motor activity, tremors and deep respirations)
in acute neurotoxicity studies following exposure by gavage; however,
no indications of neurotoxicity were observed following dietary
exposure in the subchronic neurotoxicity study in rats.
    There was no evidence of increased quantitative or qualitative
susceptibility of rat or rabbit fetuses following in utero exposure to
clothianidin in developmental studies; however, increased quantitative
susceptibility of rat pups was seen in both the reproduction and
developmental neurotoxicity studies. In the rat reproduction study,
offspring toxicity (decreased body weight gains and absolute thymus
weights in pups, delayed sexual maturation and an increase in
stillbirths) was observed in the absence of maternal effects. In the
developmental neurotoxicity study in rats, offspring effects (decreased
body weights, body weight gains, motor activity and acoustic startle
response amplitude) were noted at doses lower than those resulting in
maternal toxicity.
    Decreased absolute and relative thymus and spleen weights were
observed in multiple studies; these studies showed possible evidence of
effects on the immune system. In addition, juvenile rats in the rat
reproduction study appeared to be more susceptible to these effects.
However, a guideline immunotoxicity study showed no evidence of
clothianidin-mediated immunotoxicity in adult rats and a developmental
immunotoxicity study demonstrated no increased susceptibility for
offspring with regard to immunotoxicity.
    Specific information on the studies received and the nature of the
toxic effects caused by clothianidin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Clothianidin--Human Health Risk
Assessment of the Requested Experimental Use Permit as a Rice Seed
Treatment'' on p. 10-13 in docket ID number EPA-HQ-OPP-2010-0217.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for Clothianidin used for
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Clothianidin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/Scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 25 milligrams/  Acute RfD = 0.25 mg/kg/ Rabbit developmental study
 of age).                             kilograms/day (mg/kg/   day.                    LOAEL = 75 mg/kg/day based
                                      day).                  aPAD = 0.25mg/kg/day..   on increased litter
                                     UFA = 10x.............                           incidence of a missing
                                     UFH = 10x.............                           lobe of the lung.
                                     FQPA SF = 1x..........
Acute dietary General population...  NOAEL = 25 mg/kg/day..  Acute RfD = 0.25 mg/kg/ Special neurotoxicity/
                                     UFA = 10x.............   day.                    pharmacological study in
                                     UFH = 10x.............  aPAD = 0.25 mg/kg/day.   mice LOAEL = 50 mg/kg/day
                                     FQPA SF = 1x..........                           based on transient signs
                                                                                of decreased spontaneous
                                                                                motor activity, tremors
                                                                                and deep respirations.

Chronic dietary (All populations     NOAEL= 9.8 mg/kg/day..  Chronic RfD = 0.098 mg/ 2-Generation reproduction
 including infants and children).    UFA = 10x.............   kg/day.                 study LOAEL = 31.2 mg/kg/
                                     UFH = 10x.............  cPAD = 0.098 mg/kg/day   day based on decreased
                                     FQPA SF = 1x..........                           body weight gains and
                                                                                delayed sexual maturation,
                                                                                decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
Incidental oral (short and           NOAEL= 9.8 mg/kg/day..  LOC for MOE = 100.....  2-Generation reproduction
 intermediate term).                 UFA = 10x.............                           study LOAEL = 31.2 mg/kg/
                                     UFH = 10x.............                           day based on decreased
                                     FQPA SF = 1x..........                           body weight gains and
                                                                                delayed sexual maturation,
                                                                                decreased absolute thymus
                                                                                weights in F1 pups.
Dermal (all durations).............  Oral study NOAEL = 9.8  LOC for MOE = 100.....  2-Generation reproduction
                                      mg/kg/day (dermal                               study LOAEL = 31.2 mg/kg/
                                      absorption rate = 1%.                           day based on decreased
                                     UFA = 10x.............                           body weight gains and
                                     UFH = 10x.............                           delayed sexual maturation,
                                     FQPA SF = 1x..........                           decreased absolute thymus
                                                                                weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
Inhalation (all durations).........  Oral study NOAEL= 9.8   LOC for MOE = 100.....  2-Generation reproduction
                                      mg/kg/day (inhalation                           study LOAEL = 31.2 mg/kg/
                                      absorption rate =                               day based on decreased
                                      100%).                                          body weight gains and
                                     UFA = 10x.............                           delayed sexual maturation,
                                     UFH = 10x.............                           decreased absolute thymus
                                     FQPA SF = 1x..........                           weights in F1 pups and
                                                                                increased stillbirths in
                                                                                both generations.
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..                  ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to clothianidin, EPA considered exposure from the petitioned-
for tolerances as well as all existing clothianidin tolerances in 40
CFR 180.586. EPA assessed dietary exposures from clothianidin in food
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure.
    Such effects were identified for clothianidin. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food from use of clothianidin, EPA used tolerance-level
residues, empirical processing factors and assumed 100 percent crop
treated (PCT) for all commodities. Clothianidin is a major metabolite
of thiamethoxam, and there are a number of crops for which uses of both
clothianidin and thiamethoxam have been registered. The labels for the
various end-use products containing these active ingredients prohibit
the application of both active ingredients to the same crop during a
growing cycle. Due to that restriction and the assumption of 100 PCT, a
single value reflecting the greatest clothianidin residue from either
active ingredient has been used for crops listed for use with both
active ingredients (versus combined estimates from clothianidin and
from thiamethoxam). Generally, this assessment uses the established or
recommended clothianidin tolerance for crops having tolerances for both
compounds (the exception being low-growing berry, subgroup 13-07G,
which is based on observed clothianidin residues in thiamethoxam
strawberry field trials). For foods with thiamethoxam tolerances but
without clothianidin tolerances, maximum residues of clothianidin
observed in thiamethoxam field trials have been used in these
assessments. These include meats, meat by-products, artichoke, tropical
fruits, coffee, hop, mint, rice, and strawberry. The metabolism of
clothianidin is complex, with a few major (> 10% of the total
radioactive residues) and numerous minor metabolites. Metabolites/
degradates of concern in plants include clothianidin and TMG for leafy
and root and tuber vegetables; parent-only for other crops; and parent,
TZNG and MNG for rotational crops. For livestock commodities, the
metabolites of concern include: Parent and TZU, TZG, TZNG, and ATMG-
pyruvate for ruminants; and parent and TZU, TZG, TZNG, and ATG-acetate
for poultry. For leafy vegetables the EPA required analysis for
residues of TMG along with parent in field trial samples. Residues of
TMG were shown to occur in leafy vegetables at levels approximately 10-
fold below those of clothianidin. EPA has not included these
metabolites in the tolerance expression for plant or animal commodities
because the metabolites are only found in certain commodities,
including the metabolites would create tolerance harmonization issues
with Canada, and monitoring residues of clothianidin based on parent
only would be representative of total clothianidin residues and thus
adequate for enforcement. Because the metabolites are not included in
the tolerance expressions, an adjustment factor of 1.1 has been
incorporated into the assessment for leafy vegetables to account for
the presence of the metabolite TMG, and an adjustment factor of 1.5 has
been incorporated for livestock-derived commodities (milk) to account
for the presence of metabolites

TZU, TZG, TZNG, ATMG-pyruvate and ATG-acetate. The 1.1 adjustment
factor is based on field trial data showing TMG does not exceed 10% of
the parent compound residue level in leafy vegetables and the 1.5
factor was based on metabolism data.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assessed chronic
dietary exposure using the same residue information and assumptions
regarding metabolites/degradates as in the acute exposure analysis.
    iii. Cancer. Based on the lack of evidence of carcinogenicity in
two adequate rodent carcinogenicity studies, EPA has classified
clothianidin as ``not likely to be carcinogenic to humans.'' Therefore,
a quantitative exposure assessment to evaluate cancer risk is
unnecessary.
    iv. Anticipated residue and PCT information. For foods with
thiamethoxam tolerances but without clothianidin tolerances, maximum
residues of clothianidin observed in thiamethoxam field trials have
been used in these assessments. For all commodities, 100 PCT was
assumed.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for Clothianidin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of Clothianidin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models the estimated
drinking water concentrations (EDWCs) of Clothianidin for surface water
are estimated to be 7.29 parts per billion (ppb) for acute exposures
and 1.35 ppb for chronic exposures. For ground water, the EDWC is
estimated to be 5.88 ppb.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. The water concentration value
of 7.29 ppb was used to assess the contribution to drinking water for
the acute dietary assessment. For chronic dietary risk assessment, the
water concentration of value 5.88 ppb was used.
    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).
    Clothianidin is currently registered for use on turf. Residential
handler exposure is not expected from the currently registered or
proposed uses of clothianidin since these products are to be applied by
commercial applicators. Adult short- and intermediate-term
postapplication exposures were assessed for dermal exposures from
commercial applications (via granular push-type spreaders), dermal
post-application contact and golfer postapplication contact. For
toddlers, short- and intermediate-term postapplication incidental oral
(hand-go-mouth and soil ingestion) and dermal risks were assessed for
exposure to treated turf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
    Clothianidin is a member of the neonicotinoid class of pesticides
and is a major metabolite of another neonicotinoid, thiamethoxam.
Structural similarities or common effects 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. Although clothianidin and thiamethoxam bind
selectively to insect nicotinic acetylcholine receptors (nAChR), the
specific binding site(s)/receptor(s) for clothianidin, thiamethoxam and
the other neonicotinoids are unknown at this time. Additionally, the
commonality of the binding activity itself is uncertain, as preliminary
evidence suggests that clothianidin operates by direct competitive
inhibition, while thiamethoxam is a non-competitive inhibitor.
Furthermore, even if future research shows that neonicotinoids share a
common binding activity to a specific site on insect nAChRs, there is
not necessarily a relationship between this pesticidal action and a
mechanism of toxicity in mammals. Structural variations between the
insect and mammalian nAChRs produce quantitative differences in the
binding affinity of the neonicotinoids towards these receptors which,
in turn, confers the notably greater selective toxicity of this class
towards insects, including aphids and leafhoppers, compared to mammals.
While the insecticidal action of the neonicotinoids is neurotoxic, the
most sensitive regulatory endpoint for clothianidin is based on
unrelated effects in mammals, including changes in body and thymus
weights, delays in sexual maturation, and still births. Additionally,
the most sensitive toxicological effect in mammals differs across the
neonicotinoids (such as testicular tubular atrophy with thiamethoxam,
and mineralized particles in thyroid colloid with imidacloprid). Thus,
there is currently no evidence to indicate that neonicotinoids share
common mechanisms of toxicity, and EPA is not following a cumulative
risk approach based on a common mechanism of toxicity for the
neonicotinoids. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity, and to evaluate
the cumulative effects of such chemicals, see the policy statements
concerning common mechanism determinations, and procedures for
cumulating effects from substances found to have a common mechanism,
released by OPP on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased quantitative or qualitative susceptibility, as compared to
adults, of rat and rabbit fetuses to in utero exposure in clothianidin
developmental studies. However, increased quantitative susceptibility
was observed in both the developmental neurotoxicity and rat multi-
generation reproduction studies. In the developmental neurotoxicity
study, offspring toxicity (decreased body weight gains, motor activity
and acoustic startle response) was seen at a

lower dose than that which caused maternal toxicity. In the two-
generation rat reproduction study, offspring toxicity (decreased body
weight gains, delayed sexual maturation in males, decreased absolute
thymus weights in F1 pups of both sexes and an increase in stillbirths
in both generations) was seen at a lower dose than that which caused
parental toxicity.
    3. Conclusion. In the final rule published in the Federal Register
of February 6, 2008 (73 FR 6851) (FRL-8346-9), EPA had previously
determined that the FQPA SF for clothianidin should be retained at 10X
because EPA had required the submission of a developmental
immunotoxicity study to address the combination of evidence of
decreased absolute and adjusted organ weights of the thymus and spleen
in multiple studies in the clothianidin data base, and evidence showing
that juvenile rats in the 2-generation reproduction study appear to be
more susceptible to these potential immunotoxic effects. In the absence
of a developmental immunotoxicity study EPA concluded that there was
sufficient uncertainty regarding immunotoxic effects in the young that
the 10X FQPA SF should be retained as a database uncertainty factor.
Since that determination, EPA has received and reviewed an acceptable/
guideline developmental immunotoxicity study, which demonstrated no
treatment-related effects. Taking the results of this study into
account as well as the rest of the data on clothianidin, EPA has
determined that reliable data show the safety of infants and children
would be adequately protected if the FQPA SF for clothianidin were
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for clothianidin is complete. As noted,
the prior data gap concerning developmental immunotoxicity has been
addressed by the submission of an acceptable developmental
immunotoxicity study.
    ii. A rat developmental neurotoxicity study is available and shows
evidence of increased quantitative susceptibility of offspring.
However, EPA considers the degree of concern for the developmental
neurotoxicity study to be low for pre- and postnatal toxicity because
the NOAEL and LOAEL were well characterized, and the doses and
endpoints selected for risk assessment are protective of the observed
susceptibility; therefore, there are no residual concerns regarding
effects in the young.
    iii. While the rat multi-generation reproduction study showed
evidence of increased quantitative susceptibility of offspring compared
to adults, the degree of concern is low because the study NOAEL and
LOAEL have been selected for risk assessment purposes for relevant
exposure routes and durations. In addition, the potential immunotoxic
effects observed in the study have been further characterized with the
submission of a developmental immunotoxicity study that showed no
evidence of susceptibility. As a result, there are no concerns or
residual uncertainties for pre- and postnatal toxicity after
establishing toxicity endpoints and traditional UFs to be used in the
risk assessment for clothianidin.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on assumptions that were judged to be highly conservative and health-
protective for all durations and population subgroups, including
tolerance-level residues for clothianidin uses, adjustment factors from
metabolite data, empirical processing factors, and 100 PCT for all
commodities. Additionally, EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to clothianidin in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
and adults as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
clothianidin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to clothianidin will occupy 23% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clothianidin from food and water will utilize 19% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
Clothianidin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Clothianidin is currently registered for on turf that could result
in short-term and intermediate-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short- and intermediate-term
residential exposures to Clothianidin. Using the exposure assumptions
described in this unit for short- and intermediate-term exposures, EPA
has concluded the combined short- and intermediate-term food, water,
and residential exposures result in aggregate MOEs of greater than 380
for all population subgroups. As the aggregate MOEs are greater than
100 (the LOC) for all population subgroups, including infants and
children, short- and intermediate-term aggregate exposures to
clothianidin are not of concern to EPA.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at does that were judged
to be adequate to assess the carcinogenic potential, clothianidin was
classified as ``not likely to be carcinogenic to humans,'' and is not
expected to pose a cancer risk to humans.
    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, or to infants and children from aggregate
exposure to clothianidin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The method involves extraction of residues with
acetonitrile/water, cleanup using solid phase extraction (SPE)
cartridges, and analysis of clothianidin by liquid chromatography mass/
mass spectrometry/mass spectrometry (LC/MS/MS).
    The method 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

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for Clothianidin in/on rice,
seed.

C. Revisions to Petitioned-for Tolerances

    The tolerance is considered appropriate as proposed therefore no
revisions were needed.

V. Conclusion

    Therefore, a time-limited tolerance is established for residues of
Clothianidin, in or on rice, seed at 0.01 ppm.

VI. 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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 tolerance 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 9, 2000) do not apply to this final rule. In addition,
this final 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) (Pub. L. 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).

VII. 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: February 2, 2011.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
    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 180.586 is amended by redesignating paragraph (a) as (a)(1)
and by adding paragraph (a)(2) to read as follows:

Sec.  180.586  Clothianidin; tolerances for residues.

    (a) * * *
    (2) Time-limited tolerances are established for residues of the
insecticide clothianidin, including its metabolites and degradates.
Compliance with the tolerance levels specified below is to be
determined by measuring only clothianidin, (E)-1-(2-chloro-1,3-thiazol-
5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the following raw
agricultural commodity:

----------------------------------------------------------------------------------------------------------------
                        Commodity                              Parts per million      Expiration/revocation date
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Rice, seed..............................................                       0.01                     6/23/12
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[FR Doc. 2011-3110 Filed 2-10-11; 8:45 am]
BILLING CODE 6560-50-P