[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Rules and Regulations]
[Page 48384-48386]
[DOCID:fr23se09-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2007-0359-200915(c); FRL-8960-1]

Approval and Promulgation of Implementation Plans; Revisions to
the Alabama State Implementation Plan; Birmingham and Jackson County;
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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SUMMARY: On March 26, 2009 (71 FR 13118), EPA published a document
approving a revision to the Birmingham and Jackson County portions of
the Alabama State Implementation Plan (SIP). This action adds Table
(c), which was inadvertently omitted, to Alabama's Identification of
Plan section of the Code of Federal Regulations (CFR).

DATES: This action is effective September 23, 2009.

ADDRESSES: Copies of the documentation used in the action being
corrected are available for inspection during normal business hours at
the following location: U.S. Environmental Protection Agency, Region 4,
61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30, excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Amanetta Somerville, Air Quality
Modeling and Transportation Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia
30303-8960. Ms. Somerville's telephone number is<PHONE_NUMBER>. She can
also be reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This action adds Table (c) for a regulation
that appears in Alabama's Identification of Plan section at 40 CFR
52.50(c). The regulation, Alabama Chapter 335-3-17-.01 ``Transportation
Conformity,'' was approved by EPA on March 26, 2009 (71 FR 13170).
However, EPA inadvertently omitted Table (c) in the regulatory text of
the Direct Final Rule. EPA is correcting this inadvertent error by
inserting Table (c) into Alabama's Identification of Plan section of
the Code of Federal Regulations at 40 CFR 52.50(c).
    EPA has determined that today's action falls under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedure Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation where public notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest. Public notice and comment for this action are
unnecessary because today's action to identify, in the CFR, the state
effective date of Alabama's regulation has no substantive impact on
EPA's March 26, 2009, approval of this regulation. The omission of
Table (c) in the regulatory text of EPA's final rule published on March
26, 2009, makes no substantive difference to EPA's analysis as set out
in that rule because EPA was aware at the time of our approval that the
state regulation at issue was effective on May 26, 2009. In addition,
EPA can identify no particular reason why the public would be
interested in being notified of the correction of this omission, or in
having the opportunity to comment on the correction prior to this
action being finalized, since this correction action does not change
the meaning of the regulation at issue or otherwise change EPA's
analysis of Alabama's submittal (71 FR 13118). EPA also finds that
there is good cause under APA section 553(d)(3) for this correction to
become effective on the date of publication of this action. Section
553(d)(3) of the APA allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' 5 U.S.C. 553(d)(3). The purpose of the
30-day waiting period prescribed in APA section 553(d)(3) is to give
affected parties a reasonable time to adjust their behavior and prepare
before the final rule takes effect. Today's rule, however, does not
create any new regulatory requirements such that affected parties would
need time to prepare before the rule takes effect. Rather, today's rule
merely corrects an inadvertent error of omission in the regulatory text
of a prior rule by adding Table (c) for the Alabama regulation which
EPA approved on March 26, 2009. For these reasons, EPA finds good cause
under APA section 553(d)(3) for this correction to become effective on
the date of publication of this action.

Statutory and Executive Order Reviews

    Under the Clean Air Act (CAA), the Administrator is required to
approve a SIP submission that complies with the provisions of the Act
and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 23, 2009. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: September 10, 2009.
 J. Scott Gordon,
Acting Regional Administrator, Region 4.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart B--Alabama

0
2. In Sec.  52.50(c) the table is amended by revising the entry for
``Section 335-3-17.01'' to read as follows:

Sec.  52.50  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Alabama Regulations
----------------------------------------------------------------------------------------------------------------
                                                                State
          State citation                Title/subject      effective date    EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                  Chapter 335-3-17 Conformity of Federal Actions to State Implementation Plans
----------------------------------------------------------------------------------------------------------------
Section 335-3-17.01...............  Transportation               04/03/07  09/23/09 [Insert
                                     Conformity.                            citation of
                                                                            publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. E9-22814 Filed 9-22-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Notices]
[Pages 47869-47871]
[FR Doc No: 2023-15706]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC23-109-000.
    Applicants: Grover Hill Wind, LLC, Appalachian Power Company.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Grover Hill Wind, LLC et al.
    Filed Date: 7/14/23.
    Accession Number: 20230714-5234.

    Comment Date: 5 p.m. ET 9/12/23.
    Docket Numbers: EC23-110-000.
    Applicants: 2018 ESA Project Company, LLC, AL Fuel Cell Acquirer,
LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of 2018 ESA Project Company, LLC, et al.
    Filed Date: 7/18/23.
    Accession Number: 20230718-5194.
    Comment Date: 5 p.m. ET 8/8/23.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-232-000.
    Applicants: Great Cove Solar LLC.
    Description: Great Cove Solar LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5061.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: EG23-233-000.
    Applicants: Great Cove Solar II LLC.
    Description: Great Cove Solar II LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5062.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: EG23-234-000.
    Applicants: Tunica Windpower LLC.
    Description: Tunica Windpower LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5063.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: EG23-235-000.
    Applicants: Platteview Solar, LLC.
    Description: Platteview Solar, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5064.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: EG23-236-000.
    Applicants: Cavalier Solar A2, LLC.
    Description: Cavalier Solar A2, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5092.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: EG23-237-000.
    Applicants: McFarland Solar B, LLC.
    Description: McFarland Solar B, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5096.
    Comment Date: 5 p.m. ET 8/9/23.
    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-83-000; QF11-424-010.
    Applicants: Dana Power LLC, Gregory and Beverly Swecker v. Midland
Power Cooperative.
    Description: Complaint of Gregory and Beverly Swecker v. Midland
Power Cooperative.
    Filed Date: 7/14/23.
    Accession Number: 20230714-5237.
    Comment Date: 5 p.m. ET 8/3/23.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER23-1955-000.
    Applicants: Earthrise Lincoln Interconnection, LLC.
    Description: Report Filing: Supplement to Filing of Shared
Facilities and Use Agreements to be effective N/A.
    Filed Date: 6/23/23.
    Accession Number: 20230623-5034.
    Comment Date: 5 p.m. ET 8/2/23.

    Docket Numbers: ER23-1959-000.
    Applicants: Earthrise Crete Interconnection, LLC.
    Description: Report Filing: Supplement to Filing of Shared
Facilities and Use Agreements to be effective N/A.
    Filed Date: 6/23/23.
    Accession Number: 20230623-5035.
    Comment Date: 5 p.m. ET 8/2/23.

    Docket Numbers: ER23-2427-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Transmission
Systems, Incorporated submits tariff filing per 35.13(a)(2)(iii: ATSI
submits Amended Operating and Interconnection Agreement, SA No. 2852 to
be effective 9/18/2023.
    Filed Date: 7/18/23.
    Accession Number: 20230718-5128.
    Comment Date: 5 p.m. ET 8/8/23.

    Docket Numbers: ER23-2428-000.
    Applicants: Bucksport Generation LLC.
    Description: Sec.  205(d) Rate Filing: Bucksport Generation LLC,
IROL-CIP Rate Schedule to be effective 9/16/2023.
    Filed Date: 7/18/23.
    Accession Number: 20230718-5129.
    Comment Date: 5 p.m. ET 8/8/23.

    Docket Numbers: ER23-2429-000.
    Applicants: Stonepeak Kestrel Energy Marketing LLC.
    Description: Sec.  205(d) Rate Filing: IROL-CIP Rate Schedule to be
effective 9/16/2023.
    Filed Date: 7/18/23.
    Accession Number: 20230718-5142.
    Comment Date: 5 p.m. ET 8/8/23.

    Docket Numbers: ER23-2430-000.
    Applicants: Estrella Solar, LLC.
    Description: Sec.  205(d) Rate Filing: Master Interconnection
Services Agreement Certificate of Concurrence to be effective 7/20/
2023.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5054.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2431-000.
    Applicants: Raceway Solar 1, LLC.
    Description: Sec.  205(d) Rate Filing: Master Interconnection
Services Agreement Certificate of Concurrence to be effective 7/20/
2023.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5055.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2432-000.
    Applicants: Misenheimer Solar LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/18/2023.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5069.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2433-000.
    Applicants: Estrella Solar, LLC.
    Description: Sec.  205(d) Rate Filing: LGIA Co-Tenancy Agreement
Certificate of Concurrence to be effective 7/20/2023.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5077.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2434-000.
    Applicants: Raceway Solar 1, LLC.
    Description: Sec.  205(d) Rate Filing: LGIA Co-Tenancy Agreement
Certificate of Concurrence to be effective 7/20/2023.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5079.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2435-000.
    Applicants: ETEM Remediation Two LLC.
    Description: Baseline eTariff Filing: Notice of Succession to be
effective 12/31/9998.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5081.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2436-000.
    Applicants: Energy Harbor LLC.
    Description: Tariff Amendment: Notice of Cancellation of Reactive
Service Rate Schedule FERC No. 2 to be effective 12/31/9998.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5102.
    Comment Date: 5 p.m. ET 8/9/23.

    Docket Numbers: ER23-2437-000.
    Applicants: Energy Harbor LLC.
    Description: Energy Harbor LLC requests a one-time prospective
waiver of the 90-day prior notice requirement set forth in Schedule 2.
    Filed Date: 7/19/23.
    Accession Number: 20230719-5150.
    Comment Date: 5 p.m. ET 8/9/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 19, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15706 Filed 7-24-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Notices]
[Pages 8967-8969]
[FR Doc No: 2016-03712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0173]

Waterpipes and Waterpipe Tobacco; Public Workshop; Establishment
of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; establishment of docket; request for
comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Tobacco
Products (CTP), is announcing a public workshop to gather scientific
information on waterpipes and waterpipe tobacco and to identify areas
of research that may inform CTP's regulation of these tobacco products.
The workshop will include presentations and panel discussions about the
current state of the science, and will focus on product use and design,
smoke constituents, environmental impacts, and the impact of marketing
these products on population health, including on both users and
nonusers. FDA is also opening a public docket to receive data,
information, and comments on this topic.

DATES: The public workshop will be held on March 17, 2016, from 8:30
a.m. to 5 p.m. and on March 18, 2016, from 8:30 a.m. to 4 p.m.
Individuals who wish to attend the public workshop must register by
February 25, 2016. Submit written or electronic comments to Docket No.
FDA-2016-N-0173 by April 29, 2016.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503A), Silver Spring, MD 20993. Entrance for the public
workshop participants (non-FDA employees) is

through Building 1 where routine security check procedures will be
performed. For parking, transportation, security, and information
regarding special accommodations due to a disability, please refer to
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-0173 for ``Waterpipes and Waterpipe Tobacco; Public
Workshop; Establishment of a Public Docket.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD
20993-0002, 1-877-287-1373<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop to gather scientific
information and stimulate discussion among scientists about waterpipes
and waterpipe tobacco. The workshop will focus on waterpipe tobacco
product toxic emissions and exposure to harmful and potentially harmful
constituents including: Second hand exposure, design and environmental
concerns, prevalence, perception, use pattern, addiction, individual
and population health. FDA is interested in gathering scientific
information from individuals with a broad range of backgrounds on the
scientific topics to be discussed at the workshop. Information related
to workshop presentations and discussion topics, including specific
questions to be addressed at the workshop, can be found at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm.

II. Registration To Attend the Workshop

    If you wish to attend the workshop in person or by Webcast, you
must register by submitting either an electronic or written request no
later than February 25, 2016. Please submit electronic requests at
https://www.surveymonkey.com/r/Waterpipes2016. Persons without Internet
access may send written requests for registration to Caryn Cohen (see
FOR FURTHER INFORMATION CONTACT). Requests for registration must
include the prospective attendee's name, title, affiliation, address,
email address if available, and telephone number. Registration is free
and you may register to either attend in-person or view the live
Webcast. Both seating and viewership are limited, so early registration
is recommended. FDA may limit the number of registrants from a single
organization, as well as the total number of participants, if
registration reaches full capacity. For those registrants with Internet
access, confirmation of registration will be emailed to you no later
March 1, 2016. Onsite registration may be allowed if space is
available. If registration reaches maximum capacity, FDA will post a
notice closing registration at http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm. If you need special accommodations due to a
disability, please contact Caryn Cohen (see FOR FURTHER INFORMATION
CONTACT) no later than March 10, 2016.

III. Oral Presentations by Members of the Public

    This workshop includes a public comment session. Persons wishing to
present during the public comment session must make this request at the
time of registration and should identify the topic they wish to address
from among those topics under consideration.

FDA will do its best to accommodate requests to present. FDA urges
individuals and organizations with common interests to consolidate or
coordinate their comments, and request a single time for a joint
presentation. For those requesters with Internet access, Caryn Cohen
(see FOR FURTHER INFORMATION CONTACT) will email you regarding your
request to speak by March 1, 2016.

IV. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. It will also be available after the workshop at
http://www.fda.gov/TobaccoProducts/NewsEvents/ucm238308.htm as soon as
the official transcript is finalized.

    Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03712 Filed 2-22-16; 8:45 am]
 BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:  	6 March 2007

SUBJECT:	Thiamethoxam Acute and Chronic Aggregate Dietary and Drinking Water Exposure and Risk Assessments for FIFRA Section 3 Registration

PC Code:	060109			Decision Number:  366608

DP Number:	335846

REVIEWER:	Michael Doherty, Ph.D., Chemist

Registration Action Branch II

Health Effects Division (7509P)

THROUGH:	Sheila Piper, Chemist

Amelia Acierto, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

Richard A. Loranger, Ph.D., Branch Senior Scientist

Registration Action Branch II

Health Effects Division (7509P)

TO:		Michael Doherty, Ph.D., Chemist

		Registration Action Branch II

		Health Effects Division (7509P)

and

Dani Daniel/Venus Eagle, Product Manager

Insecticide/Rodenticide Branch

Registration Division (7505P)

Executive Summary

Acute and chronic dietary risk assessments were conducted using the Dietary Exposure Evaluation Model (DEEM-FCID™, Version 2.03) which use food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analyses were performed to evaluate Section 3 requests for new uses or revised uses of thiamethoxam on artichoke, barley, brassica vegetables, bushberry, caneberry, cotton, cranberry, cucurbit vegetables, fruiting vegetables, hops, juneberry, leafy vegetables, legume vegetables, lingonberry, mint, oilseed crops, pecan, pome fruit, potato seed pieces, root vegetables (except sugarbeet), salal, stone fruit, strawberry, tobacco, and tuberous and corm vegetables.

Thiamethoxam’s major metabolite is CGA-322704, which is also the registered active ingredient clothianidin.  Clothianidin has a complete toxicological database and appears to have effects in mammals that are different from those of thiamethoxam.  Nevertheless, in conducting these assessments, residues of clothianidin coming from thiamethoxam were added to residues of thiamethoxam per se.  The total residue was then used to estimate dietary exposure and risk.  Both the acute and chronic assessments assumed that 100% of crops with registered or requested uses of thiamethoxam were treated.  This assumption is highly conservative with respect to thiamethoxam use and removes the need to include residues of clothianidin coming from clothianidin uses.  The last risk assessment for clothianidin (M. Doherty, 9/13/06, D326758) included residues of clothianidin coming from these uses of thiamethoxam.

Both the acute and chronic dietary assessments are based on maximum residues of thiamethoxam and clothianidin observed in the thiamethoxam field trials.  As noted above, these assessments assume that 100% of crops with registered or requested uses of thiamethoxam are treated. In addition, both the acute and chronic assessments assume the maximum modeled concentration of thiamethoxam in drinking water (12.26 µg/L).  These assumptions result in conservative, health-protective estimates of exposure.  Risk estimates for acute dietary exposure for all assessed population subgroups are less than 4% of the acute population-adjusted dose (aPAD).  These estimates are well below HED’s level of concern (generally 100% of the aPAD).  Similarly, risk estimates for the chronic dietary exposure analysis are below HED’s level of concern, with the maximum estimate being 42% of the chronic population-adjusted dose (cPAD).

These analyses indicate that there are no dietary exposure considerations that would preclude registration of thiamethoxam for the requested uses.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the reference dose (RfD) divided by the special Food Quality Protection Act (FQPA) Safety Factor.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:      HYPERLINK "http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf"  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see SOP 99.6 (8/20/99).

The most recent dietary risk assessment for thiamethoxam was conducted by W. Cutchin (D278328, 12/16/2003).

II.	Residue Information

Thiamethoxam is registered for a number of commodities, with tolerances ranging from 0.02 to 1.5 ppm [40 CFR 180.565].  The major metabolite of thiamethoxam (CGA-322704) is identical to the registered active ingredient clothianidin.  These two compounds make up the residues of concern for risk assessments for thiamethoxam.

Both the acute and chronic dietary analyses are based on the maximum residues of thiamethoxam and clothianidin that were observed in the thiamethoxam field trials.  Although there is available information indicating that thiamethoxam and clothianidin have different toxicological effects in mammals and should be assessed separately, the residues of each have been combined in these assessments to ensure that the estimated exposures do not underestimate actual potential exposures.  In calculating the total residue (thiamethoxam + clothianidin), clothianidin residues were converted to thiamethoxam equivalents by multiplying by the molecular weight ratio (1.15) of these two compounds (Table 1).  Maximum values, rather than tolerance values, were used in the assessments in order to keep the same level of acute refinement as was used recently for clothianidin.  Empirical processing factors were used when available.  For food forms without empirical processing factors, DEEM 7.78 default values were used.  An assumption of 100% crop treated was made for all foods evaluated in the assessments.  Label instructions for these ingredients regarding best management practices prohibit application of another Group 4A (neonicotinoid) insecticide during the growing season.  Therefore, the assumption of 100% crop treated in these assessments removes the need to quantitatively consider the impact of clothianidin uses on exposure and risk estimates associated with thiamethoxam.  A complete listing of the inputs used in the assessments can be found in Attachment 1.  The estimates of residues in livestock commodities are unaltered from those used in the previous assessment and are not shown in Table 1.

 Table 1.  Summary of Thiamethoxam and Clothianidin (from Thiamethoxam Application) Residues Used in the Acute and Chronic Dietary Assessments for Thiamethoxam.

Group	Crop	Maximum Residue, ppm

Thiamethoxam	Clothianidin	Combined 1

Bushberry	Blueberry	0.110	0.050	0.168

Caneberry	Raspberry/Blackberry	0.200	0.040	0.246

Cereal Grain	All, except barley	0.005	0.005	0.011

Cereal Grain	Barley	0.210	0.020	0.233

Cucurbit Veg	Canteloupe	0.140	0.005	0.146

Cucurbit Veg	Cucumber	0.100	0.005	0.106

Cucurbit Veg	Summer Squash	0.130	0.005	0.136

Fruiting Veg.	Bell and non-bell peppers	0.220	0.020	0.243

Fruiting Veg.	Tomato	0.140	0.040	0.186

Fruiting Veg.	Tomato, paste	0.608	0.152	0.783

Head/Stem Brassica	Head/Stem Brassica	0.160	0.040	0.206

Leafy Brassica	Cabbage	0.120	0.020	0.143

Leafy Brassica	Mustard Green	1.600	0.360	2.014

Leafy Veg.	Celery	0.400	0.020	0.423

Leafy Veg.	Head Lettuce	0.060	0.005	0.066

Leafy Veg.	Leaf Lettuce	1.900	0.040	1.946

Leafy Veg.	Spinach	0.660	0.800	1.580

Legume Veg.	Vegetable, legume, Group 6	0.005	0.005	0.011

Oilseed	Borage, seed	0.005	0.005	0.011

Oilseed	Canola, seed	0.005	0.005	0.011

Oilseed	Crambe, seed	0.005	0.005	0.011

Oilseed	Flax, seed	0.005	0.005	0.011

Oilseed	Mustard, seed	0.005	0.005	0.011

Oilseed	Rapeseed, seed	0.005	0.005	0.011

Oilseed	Safflower, seed	0.005	0.005	0.011

Oilseed	Sunflower	0.005	0.005	0.011

Other	Artichoke, globe	0.244	0.029	0.278

Other	Coffee	0.010	0.010	0.022

Other	Cotton, undelinted seed	0.030	0.005	0.036

Other	Cranberry	0.005	0.005	0.011

Other	Grape	0.260	0.020	0.283

Other	Grape - Juice	0.231	0.020	0.254

Other	Grape - Raisins	1.222	0.020	1.245

Other	Hop	0.055	0.028	0.087

Other	Peppermint/Spearmint	0.894	0.128	1.041

Other	Strawberry	0.260	0.005	0.266

Pome Fruit	Apple	0.110	0.005	0.116

Pome Fruit	Pear	0.060	0.005	0.066

Root Veg.	Carrot	0.040	0.005	0.046

Root Veg.	Radish	0.080	0.005	0.086

Stone Fruit	Cherry	0.280	0.030	0.315

Stone Fruit	Peach	0.190	0.120	0.328

Stone Fruit	Plum	0.020	0.020	0.043

Tree Nut	Pecans	0.005	0.005	0.011

Tuber	Tuberous and Corm (inc. tol.)	0.240	0.060	0.309

Tuber	Vegetable, tuberous and corm, except potato, Subgroup 1D	0.005 0.005	0.011

1 The combined residues are expressed as thiamethoxam equivalents (i.e., thiamethoxam residue + 1.15×clothianidin residue).

 Drinking Water Data

The Estimated Drinking Water Concentrations (EDWCs) used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED; A. Al-Mudallal, D329467, 10 Jan. 07).  The EDWCs were incorporated directly into this dietary assessment in the food categories “water, direct, all sources” and “water, indirect, all sources.”

Estimated drinking water concentrations for surface water are Tier II PRZM/EXAM results based on the index reservoir scenarios and percent crop area factors.  Uses on apples, barley, cabbage, carrots, cucumbers, grapes, lettuce, peppers, strawberries, tomatoes, and turf were modeled.  The greatest residues in surface water are predicted to result from use of thiamethoxam on peppers in Florida (acute, 12.26 µg/L) and lettuce in California (chronic, 1.29 µg/L).

For groundwater, EFED used the SCI-GROW model based on the highest proposed annual use rate (grapes).  The SCI-GROW model estimated residues of thiamethoxam in shallow groundwater to be 7.94 µg/L.

These models and their descriptions can be found at the EPA internet site (  HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ ).

Both the acute and chronic assessment used the acute EDWC of 12.26 µg/L (0.0123 ppm) as a worst-case estimate of exposure via drinking water.

IV.	DEEM-FCID™ Program and Consumption Information

Thiamethoxam acute and chronic dietary exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID™, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

For acute exposure assessments, individual one-day food consumption data are used on an individual-by-individual basis.  The reported consumption amounts of each food item can be multiplied by a residue point estimate and summed to obtain a total daily pesticide exposure for a deterministic exposure assessment, or “matched” in multiple random pairings with residue values and then summed in a probabilistic assessment.  The resulting distribution of exposures is expressed as a percentage of the aPAD on both a user (i.e., only those who reported eating relevant commodities/food forms) and a per-capita (i.e., those who reported eating the relevant commodities as well as those who did not) basis.  In accordance with HED policy, per capita exposure and risk are reported for all tiers of analysis.  However, for tiers 1 and 2, any significant differences in user vs. per capita exposure and risk are specifically identified and noted in the risk assessment.

V.	Toxicological Information

The toxicology database for thiamethoxam is complete.  The scientific quality is relatively high and the toxicity profile of thiamethoxam can be characterized for most effects, including potential carcinogenic, mutagenic, developmental, and neurotoxic effects.  Newly submitted data has resulted in revisions to the acute and chronic points of departure and doses for risk assessment (see Table 2).

It is recommended that the 10X FQPA safety factor for the protection of infants and children be reduced to 1X.  There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure to thiamethoxam in the developmental toxicity studies.  The developmental NOAELs are either higher than or equal to the maternal NOAELs.  The Developmental Neurotoxity (DNT) workgroup concluded there was no evidence of increased  quantitative susceptibility in the DNT study in rats, based on evaluation of additional brain morphometric data for the low- and mid-dose pups (January 17, 2007 meeting).

Although there is evidence of increased quantitative susceptibility for male pups of both two generation reproductive studies, NOAELs and LOAELs were established in these studies, and the Agency selected the NOAEL for testicular effects in F1 pups as the basis for risk assessment.  The Agency has confidence that the NOAEL selected for risk assessment is protective of the most sensitive effect (testicular effects) for the most sensitive subgroup (pups) observed in the toxicological database.

In addition, the NOAELs selected for risk assessment are protective of all toxicological effects observed in the database including treatment-related changes in the adrenal gland, thyroid, testes and ovaries.  Thus, the Agency believes the FQPA safety factor can be reduced to 1X.

Table 2.  Toxicological Doses and Endpoints for Thiomethoxam for Use in Human Health Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary

All populations including infants and children 	NOAEL =  34.5 mg/kg/day

	UFA= 10x

UFH= 10x

SFFQPA=1

 	aRfD=0.35 mg/kg/day

aPAD=0.35 mg/kg/day	Rat Developmental Neurotoxicity study

LOAEL = 298.7 mg/kg/day based on delayed sexual maturation in male pups, and reduced brain morphometric measurements.

Chronic Dietary

All populations including infants and children	NOAEL= 1.2 mg/kg/day (46402904)

	UFA= 10x

UFH= 10x

SFFQPA=1

	cRfD=0.012 mg/kg/day

cPAD=0.012 mg/kg/day	2-Generation reproduction study (MRID 44718707)

LOAEL = 1.8 mg/kg/day based on increased incidence and severity of tubular atrophy in testes of F1 generation males.

2-Generation reproduction study (46402904)

LOAEL = 3 (males), not determined (females) mg/kg/day based on sperm abnormalities in F1 males.

Cancer (oral, dermal, inhalation)	“Not Likely to be Carcinogenic to Humans” based on convincing evidence that a non-genotoxic mode of action for liver tumors was established in the mouse and that the carcinogenic effects are a result of a mode of action dependent on sufficient amounts of a hepatotoxic metabolite produced persistently.  Quantification of cancer risk is not required.

VI.	Results/Discussion

Table 3.  Summary of Estimated Dietary (Food + Water) Exposures and Risk for Thiamethoxam.

Population Subgroup	aPAD, mg/kg	Acute Estimates	cPAD, mg/kg/day	Chronic Estimates

Exposure, mg/kg	Risk, % aPAD

Exposure, mg/kg/day	Risk, % cPAD

U.S. Population	0.35	0.004698	1	0.012	0.001630	14

All infants	0.35	0.009228	3	0.012	0.003298	28

Children 1-2 yrs	0.35	0.011707	3	0.012	0.005005	42

Children 3-5 yrs	0.35	0.008783	3	0.012	0.003718	31

Children 6-12 yrs	0.35	0.005098	1	0.012	0.002092	17

Youth 13-19 yrs	0.35	0.003206	1	0.012	0.001285	11

Adults 20-49 yrs	0.35	0.003069	1	0.012	0.001245	10

Adults 50+ yrs	0.35	0.003403	1	0.012	0.001361	11

Females 13-49 yrs	0.35	0.003151	1	0.012	0.001248	10

The population subgroup with the highest estimated exposure/risk is bolded.

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 3 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.  The acute results summarized in Table 2 are for the 95th percentile of exposure.  A complete listing of acute and chronic exposure and risk estimates can be found in Attachments 2 and 3, respectively.

The analyses indicate that the requested uses of thiamethoxam, coupled with currently registered uses, will result in acute and chronic dietary (food + water) exposures that are below HED’s level of concern for all population subgroups, including those of infants and children.

VII.	Characterization of Inputs/Outputs

Assumptions regarding estimates of residue levels and the extent to which crops are treated with thiamethoxam are highly conservative and protective of human health; especially in the case of the chronic assessment.  Actual dietary exposures to thiamethoxam and clothianidin are likely to be significantly less than the estimates provided by the DEEM-FCID simulations.

VIII.	Conclusions

Based on highly conservative assumptions, there are no dietary (food + water) exposure considerations that would preclude registration of thiamethoxam on the requested food/feed crops or establishment of tolerances at HED’s recommended levels (see CHEM REFERENCE)

IX.		List of Attachments

Attachment 1.  Input file for the acute and chronic dietary exposure analyses of thiamethoxam.

Attachment 2.  Summary of the acute dietary exposure analysis for thiamethoxam.

Attachment 3.  Summary of the chronic dietary exposure analysis for thiamethoxam.

Attachment 1.  Input file for the acute and chronic dietary exposure analyses of thiamethoxam.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for THIAMETHOXAM                       1994-98 data

Residue file: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\DEEM Runs\Clothianidin and Thiamethoxam\Thiamethoxam\060109 2006 Acute T + C from T + Water no CT.R98

                                                           Adjust. #2 NOT used

Analysis Date 01-23-2007             Residue file dated: 01-23-2007/13:48:49/8

Reference dose (RfD) = 0.012 mg/kg bw/day

Comment:Acute and Chronic RfDs = aPAD and cPAD

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

04010050 4A   Amaranth, leafy                    1.580000   1.000      1.000

11000070 11   Apple, fruit with peel             0.116000   1.000      1.000

11000080 11   Apple, peeled fruit                0.116000   1.000      1.000

11000081 11   Apple, peeled fruit-babyfood       0.116000   1.000      1.000

11000090 11   Apple, dried                       0.116000   1.000      1.000

11000091 11   Apple, dried-babyfood              0.116000   1.000      1.000

11000100 11   Apple, juice                       0.116000   1.000      1.000

11000101 11   Apple, juice-babyfood              0.116000   1.000      1.000

11000110 11   Apple, sauce                       0.116000   1.000      1.000

11000111 11   Apple, sauce-babyfood              0.116000   1.000      1.000

12000120 12   Apricot                            0.328000   1.000      1.000

12000121 12   Apricot-babyfood                   0.328000   1.000      1.000

12000130 12   Apricot, dried                     0.328000   6.000      1.000

12000140 12   Apricot, juice                     0.328000   1.000      1.000

12000141 12   Apricot, juice-babyfood            0.328000   1.000      1.000

01030150 1CD  Arrowroot, flour                   0.011000   1.000      1.000

01030151 1CD  Arrowroot, flour-babyfood          0.011000   1.000      1.000

95000160 O    Artichoke, globe                   0.278000   1.000      1.000

01030170 1CD  Artichoke, Jerusalem               0.011000   1.000      1.000

04010180 4A   Arugula                            1.580000   1.000      1.000

09020210 9B   Balsam pear                        0.106000   1.000      1.000

15000250 15   Barley, pearled barley             0.233000   0.300      1.000

15000251 15   Barley, pearled barley-babyfood    0.233000   0.300      1.000

15000260 15   Barley, flour                      0.233000   0.100      1.000

15000261 15   Barley, flour-babyfood             0.233000   0.100      1.000

15000270 15   Barley, bran                       0.233000   1.000      1.000

06030300 6C   Bean, black, seed                  0.010000   1.000      1.000

06020310 6B   Bean, broad, succulent             0.010000   1.000      1.000

06030320 6C   Bean, broad, seed                  0.010000   1.000      1.000

06020330 6B   Bean, cowpea, succulent            0.010000   1.000      1.000

06030340 6C   Bean, cowpea, seed                 0.010000   1.000      1.000

06030350 6C   Bean,  great northern, seed        0.010000   1.000      1.000

06030360 6C   Bean, kidney, seed                 0.010000   1.000      1.000

06020370 6B   Bean, lima, succulent              0.010000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.010000   1.000      1.000

06030390 6C   Bean, mung, seed                   0.010000   1.000      1.000

06030400 6C   Bean, navy, seed                   0.010000   1.000      1.000

06030410 6C   Bean, pink, seed                   0.010000   1.000      1.000

06030420 6C   Bean, pinto, seed                  0.010000   1.000      1.000

06010430 6A   Bean, snap, succulent              0.010000   1.000      1.000

06010431 6A   Bean, snap, succulent-babyfood     0.010000   1.000      1.000

21000440 M    Beef, meat                         0.020000   1.000      1.000

21000441 M    Beef, meat-babyfood                0.020000   1.000      1.000

21000450 M    Beef, meat, dried                  0.020000   1.920      1.000

21000460 M    Beef, meat byproducts              0.020000   1.000      1.000

21000461 M    Beef, meat byproducts-babyfood     0.020000   1.000      1.000

21000480 M    Beef, kidney                       0.020000   1.000      1.000

21000490 M    Beef, liver                        0.020000   1.000      1.000

21000491 M    Beef, liver-babyfood               0.020000   1.000      1.000

01010500 1AB  Beet, garden, roots                0.086000   1.000      1.000

01010501 1AB  Beet, garden, roots-babyfood       0.086000   1.000      1.000

13010550 13A  Blackberry                         0.246000   1.000      1.000

13010560 13A  Blackberry, juice                  0.246000   1.000      1.000

13010561 13A  Blackberry, juice-babyfood         0.246000   1.000      1.000

13020570 13B  Blueberry                          0.168000   1.000      1.000

13020571 13B  Blueberry-babyfood                 0.168000   1.000      1.000

13010580 13A  Boysenberry                        0.246000   1.000      1.000

05010610 5A   Broccoli                           0.206000   1.000      1.000

05010611 5A   Broccoli-babyfood                  0.206000   1.000      1.000

05010620 5A   Broccoli, Chinese                  0.206000   1.000      1.000

05020630 5B   Broccoli raab                      2.014000   1.000      1.000

05010640 5A   Brussels sprouts                   0.143000   1.000      1.000

15000650 15   Buckwheat                          0.011000   1.000      1.000

15000660 15   Buckwheat, flour                   0.011000   1.000      1.000

01010670 1AB  Burdock                            0.086000   1.000      1.000

05010690 5A   Cabbage                            0.143000   1.000      1.000

05020700 5B   Cabbage, Chinese, bok choy         2.014000   1.000      1.000

05010710 5A   Cabbage, Chinese, napa             0.143000   1.000      1.000

05010720 5A   Cabbage, Chinese, mustard          0.206000   1.000      1.000

09010750 9A   Cantaloupe                         0.146000   1.000      1.000

04020760 4B   Cardoon                            0.423000   1.000      1.000

01010780 1AB  Carrot                             0.046000   1.000      1.000

01010781 1AB  Carrot-babyfood                    0.046000   1.000      1.000

01010790 1AB  Carrot, juice                      0.046000   1.000      1.000

09010800 9A   Casaba                             0.146000   1.000      1.000

01030820 1CD  Cassava                            0.011000   1.000      1.000

01030821 1CD  Cassava-babyfood                   0.011000   1.000      1.000

05010830 5A   Cauliflower                        0.206000   1.000      1.000

01010840 1AB  Celeriac                           0.085000   1.000      1.000

04020850 4B   Celery                             0.423000   1.000      1.000

04020851 4B   Celery-babyfood                    0.423000   1.000      1.000

04020860 4B   Celery, juice                      0.423000   1.000      1.000

04020870 4B   Celtuce                            0.423000   1.000      1.000

09020880 9B   Chayote, fruit                     0.136000   1.000      1.000

12000900 12   Cherry                             0.315000   1.000      1.000

12000901 12   Cherry-babyfood                    0.315000   1.000      1.000

12000910 12   Cherry, juice                      0.315000   1.000      1.000

12000911 12   Cherry, juice-babyfood             0.315000   1.000      1.000

06030980 6C   Chickpea, seed                     0.010000   1.000      1.000

06030981 6C   Chickpea, seed-babyfood            0.010000   1.000      1.000

06030990 6C   Chickpea, flour                    0.010000   1.000      1.000

01011000 1AB  Chicory, roots                     0.046000   1.000      1.000

09021020 9B   Chinese waxgourd                   0.106000   1.000      1.000

04011040 4A   Chrysanthemum, garland             1.580000   1.000      1.000

95001150 O    Coffee, roasted bean               0.022000   1.000      1.000

95001160 O    Coffee, instant                    0.022000   1.000      1.000

05021170 5B   Collards                           2.014000   1.000      1.000

15001200 15   Corn, field, flour                 0.011000   1.000      1.000

15001201 15   Corn, field, flour-babyfood        0.011000   1.000      1.000

15001210 15   Corn, field, meal                  0.011000   1.000      1.000

15001211 15   Corn, field, meal-babyfood         0.011000   1.000      1.000

15001220 15   Corn, field, bran                  0.011000   1.000      1.000

15001230 15   Corn, field, starch                0.011000   1.000      1.000

15001231 15   Corn, field, starch-babyfood       0.011000   1.000      1.000

15001240 15   Corn, field, syrup                 0.011000   1.000      1.000

15001241 15   Corn, field, syrup-babyfood        0.011000   1.000      1.000

15001250 15   Corn, field, oil                   0.011000   1.000      1.000

15001251 15   Corn, field, oil-babyfood          0.011000   1.000      1.000

15001260 15   Corn, pop                          0.011000   1.000      1.000

15001270 15   Corn, sweet                        0.011000   1.000      1.000

15001271 15   Corn, sweet-babyfood               0.011000   1.000      1.000

95001280 O    Cottonseed, oil                    0.036000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.036000   1.000      1.000

11001290 11   Crabapple                          0.116000   1.000      1.000

95001300 O    Cranberry                          0.011000   1.000      1.000

95001301 O    Cranberry-babyfood                 0.011000   1.000      1.000

95001310 O    Cranberry, dried                   0.011000   1.000      1.000

95001320 O    Cranberry, juice                   0.011000   1.000      1.000

95001321 O    Cranberry, juice-babyfood          0.011000   1.000      1.000

04011330 4A   Cress, garden                      1.580000   1.000      1.000

04011340 4A   Cress, upland                      1.580000   1.000      1.000

09021350 9B   Cucumber                           0.106000   1.000      1.000

13021360 13B  Currant                            0.168000   1.000      1.000

13021370 13B  Currant, dried                     0.168000   1.000      1.000

04011380 4A   Dandelion, leaves                  1.580000   1.000      1.000

01031390 1CD  Dasheen, corm                      0.011000   1.000      1.000

13011420 13A  Dewberry                           0.246000   1.000      1.000

08001480 8    Eggplant                           0.240000   1.000      1.000

13021490 13B  Elderberry                         0.168000   1.000      1.000

04011500 4A   Endive                             1.580000   1.000      1.000

04021520 4B   Fennel, Florence                   0.423000   1.000      1.000

20001630 20   Flaxseed, oil                      0.011000   1.000      1.000

01031660 1CD  Ginger                             0.011000   1.000      1.000

01031661 1CD  Ginger-babyfood                    0.011000   1.000      1.000

01031670 1CD  Ginger, dried                      0.011000   1.000      1.000

01011680 1AB  Ginseng, dried                     0.046000   1.000      1.000

23001690 M    Goat, meat                         0.020000   1.000      1.000

23001700 M    Goat, meat byproducts              0.020000   1.000      1.000

23001720 M    Goat, kidney                       0.020000   1.000      1.000

23001730 M    Goat, liver                        0.020000   1.000      1.000

13021740 13B  Gooseberry                         0.168000   1.000      1.000

95001750 O    Grape                              0.283000   1.000      1.000

95001760 O    Grape, juice                       0.283000   0.890      1.000

95001761 O    Grape, juice-babyfood              0.283000   0.890      1.000

95001770 O    Grape, leaves                      0.283000   1.000      1.000

95001780 O    Grape, raisin                      0.283000   4.700      1.000

95001790 O    Grape, wine and sherry             0.283000   1.000      1.000

06031820 6C   Guar, seed                         0.010000   1.000      1.000

06031821 6C   Guar, seed-babyfood                0.010000   1.000      1.000

09011870 9A   Honeydew melon                     0.146000   1.000      1.000

95001880 O    Hop                                0.087000   1.000      1.000

24001890 M    Horse, meat                        0.020000   1.000      1.000

01011900 1AB  Horseradish                        0.046000   1.000      1.000

13021910 13B  Huckleberry                        0.168000   1.000      1.000

05021940 5B   Kale                               2.014000   1.000      1.000

05011960 5A   Kohlrabi                           0.143000   1.000      1.000

06032030 6C   Lentil, seed                       0.010000   1.000      1.000

04012040 4A   Lettuce, head                      0.066000   1.000      1.000

04012050 4A   Lettuce, leaf                      1.946000   1.000      1.000

13012080 13A  Loganberry                         0.246000   1.000      1.000

11002100 11   Loquat                             0.116000   1.000      1.000

28002210 M    Meat, game                         0.020000   1.000      1.000

27002220 D    Milk, fat                          0.020000   1.000      1.000

27002221 D    Milk, fat - baby food/infant for   0.020000   1.000      1.000

27012230 D    Milk, nonfat solids                0.020000   1.000      1.000

27012231 D    Milk, nonfat solids-baby food/in   0.020000   1.000      1.000

27022240 D    Milk, water                        0.020000   1.000      1.000

27022241 D    Milk, water-babyfood/infant form   0.020000   1.000      1.000

27032251 D    Milk, sugar (lactose)-baby food/   0.020000   1.000      1.000

15002260 15   Millet, grain                      0.011000   1.000      1.000

05022290 5B   Mustard greens                     2.014000   1.000      1.000

12002300 12   Nectarine                          0.328000   1.000      1.000

15002310 15   Oat, bran                          0.011000   1.000      1.000

15002320 15   Oat, flour                         0.011000   1.000      1.000

15002321 15   Oat, flour-babyfood                0.011000   1.000      1.000

15002330 15   Oat, groats/rolled oats            0.011000   1.000      1.000

15002331 15   Oat, groats/rolled oats-babyfood   0.011000   1.000      1.000

08002340 8    Okra                               0.240000   1.000      1.000

04012480 4A   Parsley, leaves                    1.580000   1.000      1.000

01012500 1AB  Parsley, turnip rooted             0.046000   1.000      1.000

01012510 1AB  Parsnip                            0.046000   1.000      1.000

01012511 1AB  Parsnip-babyfood                   0.046000   1.000      1.000

06022550 6B   Pea, succulent                     0.010000   1.000      1.000

06022551 6B   Pea, succulent-babyfood            0.010000   1.000      1.000

06032560 6C   Pea, dry                           0.010000   1.000      1.000

06032561 6C   Pea, dry-babyfood                  0.010000   1.000      1.000

06012570 6A   Pea, edible podded, succulent      0.010000   1.000      1.000

06032580 6C   Pea, pigeon, seed                  0.010000   1.000      1.000

06022590 6B   Pea, pigeon, succulent             0.010000   1.000      1.000

12002600 12   Peach                              0.328000   1.000      1.000

12002601 12   Peach-babyfood                     0.328000   1.000      1.000

12002610 12   Peach, dried                       0.328000   7.000      1.000

12002611 12   Peach, dried-babyfood              0.328000   7.000      1.000

12002620 12   Peach, juice                       0.328000   1.000      1.000

12002621 12   Peach, juice-babyfood              0.328000   1.000      1.000

11002660 11   Pear                               0.066000   1.000      1.000

11002661 11   Pear-babyfood                      0.066000   1.000      1.000

11002670 11   Pear, dried                        0.066000   1.000      1.000

11002680 11   Pear, juice                        0.066000   1.000      1.000

11002681 11   Pear, juice-babyfood               0.066000   1.000      1.000

14002690 14   Pecan                              0.011000   1.000      1.000

08002700 8    Pepper, bell                       0.240000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.240000   1.000      1.000

08002710 8    Pepper, bell, dried                0.240000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.240000   1.000      1.000

08002720 8    Pepper, nonbell                    0.240000   1.000      1.000

08002721 8    Pepper, nonbell-babyfood           0.240000   1.000      1.000

08002730 8    Pepper, nonbell, dried             0.240000   1.000      1.000

95002750 O    Peppermint                         1.041000   1.000      1.000

95002760 O    Peppermint, oil                    1.041000   0.050      1.000

12002850 12   Plum                               0.043000   1.000      1.000

12002851 12   Plum-babyfood                      0.043000   1.000      1.000

12002860 12   Plum, prune, fresh                 0.043000   1.000      1.000

12002861 12   Plum, prune, fresh-babyfood        0.043000   1.000      1.000

12002870 12   Plum, prune, dried                 0.043000   5.000      1.000

12002871 12   Plum, prune, dried-babyfood        0.043000   5.000      1.000

12002880 12   Plum, prune, juice                 0.043000   1.000      1.000

12002881 12   Plum, prune, juice-babyfood        0.043000   1.000      1.000

25002900 M    Pork, meat                         0.020000   1.000      1.000

25002901 M    Pork, meat-babyfood                0.020000   1.000      1.000

25002920 M    Pork, meat byproducts              0.020000   1.000      1.000

25002921 M    Pork, meat byproducts-babyfood     0.020000   1.000      1.000

25002940 M    Pork, kidney                       0.020000   1.000      1.000

25002950 M    Pork, liver                        0.020000   1.000      1.000

01032960 1C   Potato, chips                      0.309000   1.500      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.309000   1.250      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.309000   1.250      1.000

01032980 1C   Potato, flour                      0.309000   1.000      1.000

01032981 1C   Potato, flour-babyfood             0.309000   1.000      1.000

01032990 1C   Potato, tuber, w/peel              0.309000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.309000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.309000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.309000   1.000      1.000

09023080 9B   Pumpkin                            0.136000   1.000      1.000

09023090 9B   Pumpkin, seed                      0.136000   1.000      1.000

11003100 11   Quince                             0.066000   1.000      1.000

29003120 M    Rabbit, meat                       0.020000   1.000      1.000

04013130 4A   Radicchio                          0.066000   1.000      1.000

01013140 1AB  Radish, roots                      0.086000   1.000      1.000

01013160 1AB  Radish, Oriental, roots            0.086000   1.000      1.000

05023180 5B   Rape greens                        2.014000   1.000      1.000

20003190 20   Rapeseed, oil                      0.011000   1.000      1.000

20003191 20   Rapeseed, oil-babyfood             0.011000   1.000      1.000

13013200 13A  Raspberry                          0.246000   1.000      1.000

13013201 13A  Raspberry-babyfood                 0.246000   1.000      1.000

13013210 13A  Raspberry, juice                   0.246000   1.000      1.000

13013211 13A  Raspberry, juice-babyfood          0.246000   1.000      1.000

04023220 4B   Rhubarb                            0.423000   1.000      1.000

15003230 15   Rice, white                        0.011000   1.000      1.000

15003231 15   Rice, white-babyfood               0.011000   1.000      1.000

15003240 15   Rice, brown                        0.011000   1.000      1.000

15003241 15   Rice, brown-babyfood               0.011000   1.000      1.000

15003250 15   Rice, flour                        0.011000   1.000      1.000

15003251 15   Rice, flour-babyfood               0.011000   1.000      1.000

15003260 15   Rice, bran                         0.011000   1.000      1.000

15003261 15   Rice, bran-babyfood                0.011000   1.000      1.000

01013270 1AB  Rutabaga                           0.086000   1.000      1.000

15003280 15   Rye, grain                         0.011000   1.000      1.000

15003290 15   Rye, flour                         0.011000   1.000      1.000

20003300 20   Safflower, oil                     0.011000   1.000      1.000

20003301 20   Safflower, oil-babyfood            0.011000   1.000      1.000

01013310 1AB  Salsify, roots                     0.046000   1.000      1.000

26003390 M    Sheep, meat                        0.020000   1.000      1.000

26003391 M    Sheep, meat-babyfood               0.020000   1.000      1.000

26003400 M    Sheep, meat byproducts             0.020000   1.000      1.000

26003420 M    Sheep, kidney                      0.020000   1.000      1.000

26003430 M    Sheep, liver                       0.020000   1.000      1.000

15003440 15   Sorghum, grain                     0.011000   1.000      1.000

15003450 15   Sorghum, syrup                     0.011000   1.000      1.000

06003470 6    Soybean, seed                      0.010000   1.000      1.000

06003480 6    Soybean, flour                     0.010000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.010000   1.000      1.000

06003490 6    Soybean, soy milk                  0.010000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.010000   1.000      1.000

06003500 6    Soybean, oil                       0.010000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.010000   1.000      1.000

95003520 O    Spearmint                          1.041000   1.000      1.000

95003530 O    Spearmint, oil                     1.041000   0.050      1.000

04013550 4A   Spinach                            1.580000   1.000      1.000

04013551 4A   Spinach-babyfood                   1.580000   1.000      1.000

09023560 9B   Squash, summer                     0.136000   1.000      1.000

09023561 9B   Squash, summer-babyfood            0.136000   1.000      1.000

09023570 9B   Squash, winter                     0.136000   1.000      1.000

09023571 9B   Squash, winter-babyfood            0.136000   1.000      1.000

95003590 O    Strawberry                         0.266000   1.000      1.000

95003591 O    Strawberry-babyfood                0.266000   1.000      1.000

95003600 O    Strawberry, juice                  0.266000   1.000      1.000

95003601 O    Strawberry, juice-babyfood         0.266000   1.000      1.000

20003640 20   Sunflower, seed                    0.011000   1.000      1.000

20003650 20   Sunflower, oil                     0.011000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.011000   1.000      1.000

01033660 1CD  Sweet potato                       0.011000   1.000      1.000

01033661 1CD  Sweet potato-babyfood              0.011000   1.000      1.000

04023670 4B   Swiss chard                        0.423000   1.000      1.000

01033710 1CD  Tanier, corm                       0.011000   1.000      1.000

08003740 8    Tomatillo                          0.180000   1.000      1.000

08003750 8    Tomato                             0.180000   1.000      1.000

08003751 8    Tomato-babyfood                    0.180000   1.000      1.000

08003760 8    Tomato, paste                      0.180000   3.800      1.000

08003761 8    Tomato, paste-babyfood             0.180000   3.800      1.000

08003770 8    Tomato, puree                      0.180000   1.000      1.000

08003771 8    Tomato, puree-babyfood             0.180000   1.000      1.000

08003780 8    Tomato, dried                      0.180000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.180000  14.300      1.000

08003790 8    Tomato, juice                      0.180000   1.000      1.000

15003810 15   Triticale, flour                   0.011000   1.000      1.000

15003811 15   Triticale, flour-babyfood          0.011000   1.000      1.000

01033870 1CD  Turmeric                           0.011000   1.000      1.000

01013880 1AB  Turnip, roots                      0.086000   1.000      1.000

05023890 5B   Turnip, greens                     2.014000   1.000      1.000

86010000 O    Water, direct, all sources         0.012300   1.000      1.000

86020000 O    Water, indirect, all sources       0.012300   1.000      1.000

09013990 9A   Watermelon                         0.146000   1.000      1.000

09014000 9A   Watermelon, juice                  0.146000   1.000      1.000

15004010 15   Wheat, grain                       0.011000   1.000      1.000

15004011 15   Wheat, grain-babyfood              0.011000   1.000      1.000

15004020 15   Wheat, flour                       0.011000   1.000      1.000

15004021 15   Wheat, flour-babyfood              0.011000   1.000      1.000

15004030 15   Wheat, germ                        0.011000   1.000      1.000

15004040 15   Wheat, bran                        0.011000   1.000      1.000

15004050 15   Wild rice                          0.011000   1.000      1.000

01034060 1CD  Yam, true                          0.011000   1.000      1.000

01034070 1CD  Yam bean                           0.011000   1.000      1.000

Attachment 2.  Summary of the acute dietary exposure analysis for thiamethoxam.

U.S. Environmental Protection Agency                                  Ver. 2.02

DEEM-FCID ACUTE Analysis for THIAMETHOXAM                        (1994-98 data)

Residue file:<PHONE_NUMBER> Acute T + C from T + Water no CT.R98

Adjustment factor #2 NOT used.

Analysis Date: 01-23-2007/13:51:05    Residue file dated: 01-23-2007/13:48:49/8

Daily totals for food and foodform consumption used.

Run Comment: "Acute and Chronic RfDs = aPAD and cPAD"

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure   % aRfD

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

U.S. Population:

                    0.004698     1.34    0.008688     2.48    0.016569     4.73

All infants:

                    0.009228     2.64    0.019340     5.53    0.032703     9.34

Children 1-2 yrs:

                    0.011707     3.34    0.019173     5.48    0.045434    12.98

Children 3-5 yrs:

                    0.008783     2.51    0.013907     3.97    0.027117     7.75

Children 6-12 yrs:

                    0.005098     1.46    0.007808     2.23    0.012387     3.54

Youth 13-19 yrs:

                    0.003206     0.92    0.006809     1.95    0.012119     3.46

Adults 20-49 yrs:

                    0.003069     0.88    0.005561     1.59    0.010703     3.06

Adults 50+ yrs:

                    0.003403     0.97    0.006234     1.78    0.010762     3.07

Females 13-49 yrs:

                    0.003151     0.90    0.005606     1.60    0.010954     3.13

Attachment 3.  Summary of the chronic dietary exposure analysis for thiamethoxam.

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for THIAMETHOXAM                     (1994-98 data)

Residue file name: C:\Documents and Settings\mdoherty\My Documents\Chemistry Reviews\DEEM Runs\Clothianidin and Thiamethoxam\Thiamethoxam\060109 2006 Acute T + C from T + Water no CT.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 01-23-2007/13:49:26     Residue file dated: 01-23-2007/13:48:49/8

Reference dose (RfD, Chronic) = .012 mg/kg bw/day

COMMENT 1: Acute and Chronic RfDs = aPAD and cPAD

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.001630                13.6%

U.S. Population (spring season)             0.001619                13.5%

U.S. Population (summer season)             0.001705                14.2%

U.S. Population (autumn season)             0.001604                13.4%

U.S. Population (winter season)             0.001592                13.3%

Northeast region                            0.001664                13.9%

Midwest region                              0.001633                13.6%

Southern region                             0.001532                12.8%

Western region                              0.001753                14.6%

Hispanics                                   0.001671                13.9%

Non-hispanic whites                         0.001591                13.3%

Non-hispanic blacks                         0.001686                14.0%

Non-hisp/non-white/non-black                0.002029                16.9%

All infants (< 1 year)                      0.003298                27.5%

Nursing infants                             0.001526                12.7%

Non-nursing infants                         0.003970                33.1%

Children 1-6  yrs                           0.003996                33.3%

Children 7-12 yrs                           0.001962                16.4%

Females 13-19 (not preg or nursing)         0.001194                 9.9%

Females 20+ (not preg or nursing)           0.001305                10.9%

Females 13-50 yrs                           0.001325                11.0%

Females 13+ (preg/not nursing)              0.001357                11.3%

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               13.2%

Males 13-19 yrs                             0.001371                11.4%

Males 20+ yrs                               0.001262                10.5%

Seniors 55+                                 0.001373                11.4%

Children 1-2 yrs                            0.005005                41.7%

Children 3-5 yrs                            0.003718                31.0%

Children 6-12 yrs                           0.002092                17.4%

Youth 13-19 yrs                             0.001285                10.7%

Adults 20-49 yrs                            0.001245                10.4%

Adults 50+ yrs                              0.001361                11.3%

Females 13-49 yrs                           0.001248                10.4%

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

Thiamethoxam	Dietary Exposure and Risk Assessment	DP Number:  335846

PC Code:  060109

Page   PAGE  3  of   NUMPAGES  15


[Federal Register: January 11, 2007 (Volume 72, Number 7)]
[Notices]
[Page 1358-1359]
[DOCID:fr11ja07-74]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55027; File No. SR-Phlx-2006-53]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Granting Approval to Proposed Rule Change as Modified by
Amendment No. 1 Thereto, Relating to Assignments in Options Based on
Root Symbol

December 29, 2006.

I. Introduction

    On August 18, 2006, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Phlx Rule 507, ``Application for
Assignment in Streaming Quote Options.'' Specifically, Phlx proposes to
adopt new Commentary .01 to Phlx Rule 507, which would authorize the
Exchange's Options Allocation, Evaluation and Securities Committee
(``OAESC''),\3\ to assign trading privileges in options to Streaming
Quote Traders

(``SQTs'') \4\ and Remote Streaming Quote Traders (``RSQTs'') \5\ by
``root symbol'' (as defined more fully below), such that an SQT or RSQT
may be assigned in only certain series of an option. On November 21,
2006, the Exchange filed Amendment No. 1 to the proposed rule change.
The proposed rule change was published for comment in the Federal
Register on November 29, 2006.\6\ The Commission received one comment
letter on the proposed rule change.\7\ This order approves the proposed
rule change as modified by Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Phlx By-Law Article X, Section 10-7(a). See also Phlx
Rule 500.
    \4\ See Phlx Rule 1014(b)(ii)(A).
    \5\ See Phlx Rule 1014(b)(ii)(B).
    \6\ See Securities Exchange Act Release No. 54807 (November 21,
2006), 71 FR 69173.
    \7\ See letter to Nancy Morris, Secretary, Commission, from
Christopher Nagy, Chair, SIFMA Options Committee (``SIFMA''), dated
December 20, 2006. SIFMA does not directly oppose Phlx's quote
mitigation proposal discussed herein, but instead favors the
adoption of a comprehensive industry-wide quote mitigation strategy.
Specifically, SIFMA believes that the adoption of an industry-wide,
uniform ``holdback timer'' proposal would provide the most effective
means of quote mitigation. Although, SIFMA expressed concern that a
lack of uniformity among quote mitigation strategies implemented by
the various options exchanges may impose a burden on member firms
and result in confusion among market participants, SIFMA does not
specifically oppose the adoption of the quote mitigation proposal
approved by this order. Additional concerns raised in SIFMA's
December 20, 2006 comment letter relating to other proposed rule
changes filed by the options exchanges will be more fully addressed
in any subsequent releases issued by the Commission.
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II. Description of the Proposal

    The purpose of the proposed rule change is to mitigate quote
traffic and address quote capacity issues by reducing the number of
quotations required to be submitted on the Exchange. The proposal would
permit the OAESC to assign trading privileges to SQTs and RSQTs, upon
their request, only in specific series of a particular option based on
the ``root symbol'' of the series, instead of assigning trading
privileges in all series of such option. Thus, as described below, SQTs
and RSQTs would be required to submit quotations in fewer series.
    Phlx Rule 507 currently provides the solicitation, application and
review process to be followed by the OAESC when an SQT or RSQT submits
an application for assignment in an option. Under Phlx Rule 507, an
application for assignment must be submitted in writing to the
Exchange's designated staff and would be required to include, at a
minimum, the name of the SQT or RSQT applicant and written verification
from the Exchange's Membership Services Department that such SQT or
RSQT applicant is qualified as a ROT.
    The Exchange proposes to permit SQT and RSQT applicants to request
assignment in an option by ``root symbol.'' Today, all assignments are
by overlying option, meaning the SQT and RSQT applicants that are
assigned in a particular option are assigned in all series of such
option. Therefore, the calculation of the percentage of series required
to be quoted is based on every series listed in such option, thus
requiring SQTs and RSQTs to quote most series.
    Root symbols are the basic symbols used to identify an option, such
as, for example, ``ABQ'' for options on fictitious ``ABC Corporation.''
The various series of options on ABC Corporation are identified with
two additional symbols reflecting the expiration month and the strike
price, which also indicate whether it is a put or call option. ABC
Corporation may have different root symbols other than ABQ because of
the number of strike prices (there are not enough letters in the
alphabet to capture all potential strike prices), the expiration months
available, and whether any mergers or acquisitions have occurred. Thus,
an option on the Exchange overlying a single underlying security could
have several different root symbols.
    The Exchange anticipates that, if options can be assigned by root
symbol, SQTs and RSQTs may more carefully tailor their requests to the
specific roots in which they are interested. According to the Exchange,
SQTs and RSQTs often submit quotes with bid/ask differentials as wide
as the Exchange's rules permit in series that they have no interest in
quoting.\8\ The Exchange believes that, as a result, to meet their
quoting continuity requirements,\9\ SQTs and RSQTs submit continuous
quotations that are not at or even near the best bid or offer on the
Exchange, nor the National Best Bid or Offer, resulting in unnecessary
quote traffic on the Exchange.
---------------------------------------------------------------------------

    \8\ Streaming Quote Options trading on the Exchange's fully
electronic trading platform for options, Phlx XL, may be quoted
electronically with a difference not to exceed $5 between the bid
and offer regardless of the price of the bid. The $5 bid/ask
differentials only apply to Streaming Quote Options trading on Phlx
XL and only following the opening rotation in each security. See
Phlx Rule 1014(c)(i)(A)(2).
    \9\ See Phlx Rule 1014(b)(ii)(D)(1).
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III. Discussion

    After careful review of the proposal and consideration of the
comment letter, the Commission finds that the proposed rule change, as
modified by Amendment No. 1, is consistent with the requirements of the
Act and the rules and regulations thereunder applicable to a national
securities exchange.\10\ In particular, the Commission finds that the
proposal is consistent with Section 6(b)(5) of the Act,\11\ which
requires, among other things, that the rules of an exchange be designed
to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \10\ In approving this proposed rule change the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Commission believes that the Exchange's proposal to, upon
request, assign trading privileges in options to SQTs and RSQTs by
``root symbol'' would permit the Phlx's traders to select the series of
options that they are most interested in quoting. This should not only
reduce the number of series assigned to SQTs and RSQTs by the OAESC,
but should also reduce the number of quotes submitted by SQTs and
RSQTs, and therefore should help to mitigate the Exchange's quote
message traffic and capacity.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-Phlx-2006-53), as modified
by Amendment No. 1, be, and hereby is approved.
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    \12\ 15 U.S.C. 78s(b)(2).
    \13\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-232 Filed 1-10-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 210 (Monday, October 31, 2011)]
[Notices]
[Pages 67177-67178]
[FR Doc No: 2011-28089]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-5-000]

Pacific Gas and Electric Company; California Independent System
Operator Corporation; Notice of Complaint

    Take notice that on October 24, 2011, pursuant to section 206 of
the Federal Power Act and Rule 206 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedures, 18 CFR
385.206, Pacific Gas and Electric Company (Complainant) file a
complaint against the California Independent System Operator
Corporation (Respondent), alleging that the application of certain
provisions of the Respondent's Tariff to impose a penalty on the
Complainant, based on an earlier, unmodified section of the
Respondent's Tariff is unjust and unreasonable.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to

intervene, and protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 14, 2011.

    Dated: October 25, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-28089 Filed 10-28-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Page 23408]
[FR Doc No: 2021-09177]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4592-DR; Docket ID FEMA-2021-0001]

Kentucky; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Kentucky (FEMA-4592-DR), dated March
31, 2021, and related determinations.

DATES: The declaration was issued March 31, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 31, 2021, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Kentucky resulting from severe winter storms,
landslides, and mudslides during the period of February 8 to
February 19, 2021, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the Commonwealth of Kentucky.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the state.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, John Brogan, of FEMA is appointed to
act as the Federal Coordinating Officer for this major disaster.
    The following areas of the Commonwealth of Kentucky have been
designated as adversely affected by this major disaster:

    Bath, Boyd, Boyle, Breathitt, Carter, Casey, Clark, Clay,
Clinton, Elliott, Estill, Fleming, Floyd, Garrard, Greenup, Harlan,
Jackson, Johnson, Laurel, Lawrence, Lee, Leslie, Lewis, Lincoln,
Madison, Magoffin, Marion, Martin, McCreary, Menifee, Mercer,
Montgomery, Morgan, Nelson, Nicholas, Owsley, Perry, Powell,
Pulaski, Rockcastle, Rowan, Wayne, Whitley, and Wolfe Counties for
Public Assistance.
    All areas within the Commonwealth of Kentucky are eligible for
assistance under the Hazard Mitigation Grant Program.

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

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-09177 Filed 4-30-21; 8:45 am]
BILLING CODE 9111-23-P