[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67922-67923]
[FR Doc No: 2022-24521]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0576]

Draft Guidance for Nationally Consistent Coastal Zone Area
Contingency Plan Architecture

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability and request for comments.

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

SUMMARY: The Coast Guard announces the availability, in the docket, of
a draft guidance document intended to establish a new, nationally
consistent architecture for coastal zone Area Contingency Plans (ACPs).
ACPs are required by the Clean Water Act and demonstrate the planning
for oil and hazardous substance incident response at the local level.
ACPs for areas within the coastal zone are approved by the Coast Guard.
To modernize coastal ACPs, improve usability and attain national
consistency the Coast Guard is developing new policy pertaining to ACP
architecture. This new, standardized construct will better enable
industry plan writers of vessel and facility response plans with
multiple, diverse operating areas to consistently align with Coast
Guard approved ACPs. A more standardized approach will minimize
confusion due to highly variable ACP structure and content and will
also facilitate more efficient response, especially for large sale
responses requiring mobilization of personnel and resources from
outside the region. Additionally, adopting a nationally consistent
architecture will facilitate the Coast Guard's development of more
modern, app-based ACP products for end users.

DATES: Comments must be submitted to the online docket via https://www.regulations.gov on or before January 9, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2022-0576 using the Federal eRulemaking Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: For information about this document
call or email Jonathan Smith, Coast Guard; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION:

Public Participation and Comments

    We encourage you to submit comments (or related material) on the
draft guidance document in the docket. We will consider all submissions
and may adjust our final action based on your comments. The Coast Guard
Office of Marine Environmental Response Policy will release A Marine
Safety Information Bulletin (MSIB) containing the final product. When
available, the MSIB will be posted here: https://homeport.uscg.mil/missions/environmental/hq-mer-msib. If you submit a comment, please
include the docket number for this notice, indicate the specific
section of this document to which each comment applies, and provide a
reason for each suggestion or recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice as being available in
the docket, and public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. We review all comments received, but we may choose not to
post off-topic, inappropriate, or duplicate comments that we receive.
If you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).
    The USCG requests comments from all stakeholders who use or have a
role in the development of ACPs, including but not limited to: federal
agencies with a nexus to the National Response System; tribal
representatives; State and local agencies (Local Emergency Planning
Committees; emergency managers, response personnel; Oil Spill Removal
Organizations and environmental consultants; Non-profit and voluntary
organizations; Industry plan holders; and any other organizations
active in area committee functions. Comments received will be
considered in preparing final guidance document(s).

Background and Purpose

    ACPs are required by Title IV, Section 4202 of the Oil Pollution
Act of 1990, which amends Subsection (j) of Section 311 of the Federal
Water Pollution Control Act (33 U.S.C. 1321 (j)), as amended by the
Clean Water Act of 1977 (33 U.S.C. 1251 et. seq.) to address the
development of a National Planning and Response System. ACPs are also
written in conjunction with the National Oil and Hazardous Substance
Pollution Contingency Plan (NCP) (40 CFR part 300) and the
Comprehensive Environmental Response, Compensation and Liability Act of
1980 (42 U.S.C. 9601 et seq.) as amended by the Superfund Amendments
and Reauthorization Act of 1986. Under the

NCP, the Coast Guard and Environmental Protection Agency (EPA) provide
the leadership of the National Response Team (NRT), the Regional
Response Teams (RRT) and local Area Committees to engage the National
Response System to verify threats (spill potential), identify risks
(resources that might be harmed in a spill), and establish the
strategies necessary to prepare for and respond to a pollution incident
or event.
    The Coast Guard and EPA are responsible for organizing and
overseeing the Area Committees and each Area Committee is responsible
for developing the ACP for their area of responsibility. ACPs outline
the plan for oil and hazardous substance incident response at the local
level. Additionally, ACPs describe the strategy for the Federal On-
Scene Coordinator (FOSC) to achieve a unified and coordinated response
with federal, state, local, tribal, territorial, responsible party
(RP), and other stakeholders. The predesignated FOSC has the legal
responsibility to both plan for and respond to oil or hazardous
substance spills in their area of responsibility. Pursuant to Executive
Order 12777 (of October 22, 1991) the EPA provides the FOSC responsible
for overseeing area contingency planning and response in the inland
zone and the Coast Guard provides the FOSC for the coastal zone.
    As per the NCP, the coastal zone is defined as ``all United States
waters subject to the tide, United States waters of the Great Lakes,
specified ports and harbors on inland rivers, waters of the contiguous
zone, other waters of the of the high seas subjected to the NCP, and
the land surface or land substrata, ground waters, and ambient air
proximal to those waters.'' ACPs are an integral component of the
National Response System, as outlined in the NCP, which is comprised of
federal, state, and local responders and private sector partners. The
NRS provides a framework for coordination to respond effectively and
efficiently to oil discharges; releases of hazardous substances,
pollutants and contaminants; and radiological substances. As prescribed
in the NCP, ACPs are part of a broader, layered system of plans
designed to work in a synchronized manner. As required by the FWPCA,
vessel and facility response plans must be consistent with the
applicable ACPs for the areas in which they operate.
    Please note that the proposed guidance is for a macro level ACP
architecture only, and that the USCG recognizes that some degree of
local variability is expected beneath the macro level elements. The
USCG will continue to advance additional, more detailed policy guidance
supporting this new ACP architecture.
    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: November 4, 2022.
T.L. Wirth,
Captain, U.S. Coast Guard, Office of Marine Environmental Response
Policy.
[FR Doc. 2022-24521 Filed 11-9-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: February 27, 2009 (Volume 74, Number 38)]
[Proposed Rules]
[Page 8888-8889]
[DOCID:fr27fe09-18]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2008-0485; A-1-FRL-8771-4]

Approval and Promulgation of Air Quality Implementation Plans;
New Hampshire; 2009 Motor Vehicle Emissions Budgets for the Boston-
Manchester-Portsmouth (SE), New Hampshire, 8-Hour Ozone Nonattainment
Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to approve a State Implementation Plan
(SIP) revision submitted by the State of New Hampshire. This revision
contains 8-hour ozone transportation conformity emission budgets for
the Boston-Manchester-Portsmouth (SE), New Hampshire, 8-hour ozone
nonattainment area. This action is being taken under the Clean Air Act.

DATES: Written comments must be received on or before March 30, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R01-
OAR-2008-0485 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R01-OAR-2008-0485'', Anne Arnold, U.S. Environmental
Protection Agency, EPA New England Regional Office, One Congress
Street, Suite 1100 (mail code CAQ), Boston, MA 02114-2023.
    5. Hand Delivery or Courier. Deliver your comments to: Anne Arnold,
Manager, Air Quality Planning Unit, Office of Ecosystem Protection,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, 11th floor, (CAQ), Boston, MA 02114-2023. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 to 4:30, excluding legal holidays.
    Please see the direct final rule which is located in the Rules
Section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Donald O. Cooke, Air Quality Unit,
U.S. Environmental Protection Agency, EPA New England Regional Office,
One Congress Street, Suite 1100 (CAQ), Boston, MA 02114-2023, telephone
number<PHONE_NUMBER>, fax number<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules Section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this action
rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

    For additional information, see the direct final rule which is
located in the Rules Section of this Federal Register.

    Dated: January 27, 2009.
Ira W. Leighton,
Acting Regional Administrator, EPA New England.
[FR Doc. E9-4135 Filed 2-26-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Notices]
[Page 55674]
[FR Doc No: 2020-19862]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).
    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for electronic review at the Commission in the Public
Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits, in the docket number field to access
the document. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>.

----------------------------------------------------------------------------------------------------------------
                  Docket No.                    File date                  Presenter or requester
----------------------------------------------------------------------------------------------------------------
Prohibited:
    NONE
Exempt:
    ER19-1958-000............................    8-20-2020  U.S. Congress \1\
----------------------------------------------------------------------------------------------------------------
\1\ U.S. Representatives Jeff Duncan and G.K. Butterfield.

    Dated: September 1, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-19862 Filed 9-8-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 243 (Wednesday, December 19, 2018)]
[Rules and Regulations]
[Pages 65088-65091]
[FR Doc No: 2018-27356]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0308; FRL-9987-98-Region 4]

Air Plan Approval; KY; Updates to Attainment Status Designations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve portions of a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Kentucky, through the
Kentucky Division for Air Quality, on December 13, 2016. The changes to
the SIP that EPA is taking final action to approve are the attainment
status designations, as of October 6, 2016, for geographic areas within
the Commonwealth for several national ambient air quality standards
(NAAQS). The updates are being made to conform Kentucky's attainment
status tables with the federal attainment status designations made for
these areas. EPA has determined that the December 13, 2016, SIP
revision is consistent with the Clean Air Act (CAA or Act) and EPA's
regulations.

DATES: This rule will be effective January 18, 2019.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2018-0308. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Madolyn Sanchez, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. Sanchez can be reached via telephone at<PHONE_NUMBER>
or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Sections 108 and 109 of the CAA require EPA to set NAAQS for
criteria air pollutants: Ozone (O3); particulate matter
(PM); carbon monoxide (CO); lead (Pb); sulfur dioxide (SO2);
and nitrogen dioxide (NO2); and to undertake periodic review
of these standards. After EPA sets a new NAAQS or revises an existing
standard, the CAA requires EPA to determine if areas of the country
meet the new standards and to designate areas as either nonattainment,
unclassifiable/attainment, or unclassifiable. Such designations inform
the state's planning and implementation of requirements to achieve and
maintain the NAAQS for each area within that state.
    Section 107(d) of the CAA governs the process for these initial
area designations. Under this process, states and tribes submit
recommendations to EPA as to whether or not an area is attaining the
NAAQS for criteria air pollutants. EPA then considers these
recommendations as part of its obligation to promulgate the area
designations and boundaries for the new or revised NAAQS. EPA codifies
its designations for areas within each state in 40 CFR part 81.\1\
Under section 107(d) of the CAA, a designation for an area remains in
effect until redesignated by EPA.
---------------------------------------------------------------------------

    \1\ EPA's attainment status designations for Kentucky are found
at 40 CFR 81.318.
---------------------------------------------------------------------------

    In a proposed rulemaking published on September 21, 2018 (83 FR
47856), EPA proposed to approve changes to Kentucky regulation 401 KAR
51:010, which update, as of October 6, 2016, the description and
attainment or nonattainment status of geographic areas within the
Commonwealth with regard to a number of the NAAQS. The Commonwealth of
Kentucky last amended Regulation 401 KAR 51:010 in 1997 and, since that
time, EPA has promulgated several changes to the designations of areas
within the Commonwealth. As a result, Kentucky has amended Regulation
401 KAR 51:010 by updating, as of October 6, 2016, the attainment
status designations in Sections 4 through 8 and Section 10 for CO, Pb,
NO2, O3, PM2.5, and total suspended
solids \2\ to conform with EPA's designations as reflected in 40 CFR
81.318. Regulation 401 KAR 51:010 has also been amended by making minor
textual modifications to the NECESSITY, FUNCTION, AND CONFORMITY
section and Section 1 (Definitions) and Section 2 (Attainment Status
Designations). The details of Kentucky's submission and the rationale
for EPA's action are explained in the proposed rulemaking. Comments on
the proposed rulemaking were due on or before October 22, 2018. EPA did
not receive any relevant comments on the proposed action. EPA is now
taking final action to approve the above-referenced revisions.
---------------------------------------------------------------------------

    \2\ EPA is not taking final action on the portion of the
submittal (Section 9) that modifies the attainment status
designations for SO2.
---------------------------------------------------------------------------

II. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Kentucky
regulation 401 KAR 51:010, Attainment Status Designations, effective
October 6, 2016, which was revised to be consistent with the current
NAAQS.\3\ EPA has made, and will continue to make, these materials
generally available through www.regulations.gov and at the EPA Region 4
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the SIP, have been incorporated by reference by EPA into that plan, are
fully federally enforceable under sections 110 and 113 of the CAA as of
the effective date of the final rulemaking of EPA's approval, and will
be incorporated by reference in the next update to the SIP
compilation.\4\
---------------------------------------------------------------------------

    \3\ With the exception of Section 9. Attainment Status
Designations for Sulfur Dioxide (SO2).
    \4\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Action

    EPA is taking final action to approve portions of the Commonwealth
of Kentucky's SIP revision submitted on December 13, 2016, because the
changes are consistent with the CAA and EPA regulations. The submission
revises Kentucky's attainment status designations tables for several
NAAQS to conform with the federal attainment status designations made
for geographic areas within the Commonwealth.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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. 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it 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 February 19, 2019. 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, Sulfur
oxides, Volatile organic compounds.

    Dated: November 28, 2018.
Mary S. Walker,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart S--Kentucky

0
2. In Sec.  52.920, table 1 in paragraph (c) is amended by revising the
entry ``401 KAR 51:010'' to read as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (c) * * *

                                   Table 1--EPA-Approved Kentucky Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State
       State citation             Title/subject       effective      EPA approval date          Explanation
                                                         date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
               Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
401 KAR 51:010.............  Attainment status          10/06/16  12/19/18, [insert       With the exception of
                              Designations.                        Federal Register        Section 9. Attainment
                                                                   citation].              Status Designations
                                                                                for Sulfur Dioxide
                                                                                (SO2).

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

* * * * *
[FR Doc. 2018-27356 Filed 12-18-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 12, 2007 (Volume 72, Number 28)]
[Notices]
[Page 6564-6566]
[DOCID:fr12fe07-82]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0069; FRL-8277-6]

Agency Information Collection Activities; Proposed Collection;
Comment Request; The SunWise Program; EPA ICR No. 1940.02, OMB Control
No. 2060-0439

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR is
scheduled to expire on 9/30/2007. Before submitting the ICR to OMB for
review and approval, EPA is soliciting comments on specific aspects of
the proposed information collection as described below.

DATES: Comments must be submitted on or before April 13, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0069, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (temporarily out of service).
     Mail: The SunWise Program, Environmental Protection
Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW., Washington, DC
20460.
     Hand Delivery: EPA Air and Radiation Docket Center, EPA
West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0069. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Luke Hall-Jordan, Stratospheric
Protection Division, Office of Air and Radiation, Mail code: 6205J,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
343-2338; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2007-0069, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and Radiation

Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Reading Room is 202-566-
1744, and the telephone number for Air and Radiation Docket is 202-566-
1742.
    Use http://www.regulations.gov to obtain a copy of the draft collection of

information, submit or view public comments, access the index listing
of the contents of the docket, and to access those documents in the
public docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document.

What Information Is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    (i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility;
    (ii) Evaluate the accuracy of the Agency's estimate of the burden
of the proposed collection of information, including the validity of
the methodology and assumptions used;
    (iii) Enhance the quality, utility, and clarity of the information
to be collected; and
    (iv) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses. In particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Docket ID No.: EPA-HQ-OAR-2007-0069
    Affected entities: Entities potentially affected by this action are
elementary and middle school students, parents, and educators (informal
and external educators).
    Title: The SunWise Program.
    ICR numbers: EPA ICR No. 1940.02, OMB Control No. 2060-0439.
    ICR status: This ICR is currently scheduled to expire on September
30, 2007. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The goal of the SunWise School Program is to teach
children and their care givers how to protect themselves from
overexposure to the sun. The SunWise Program recognizes the challenge
of measuring the progress and evaluating the effectiveness of an
environmental and public health education program where the ultimate
goal is to reduce risk and improve public health. Therefore, the
continual and careful evaluation of program effectiveness through a
variety of means, including data from pre- and post-intervention
surveys, tracking and monitoring of classroom activities and school
policies, and advisory board meetings, is necessary to monitor progress
and refine the program. Surveys to be developed and administered
include: (1) Student survey to identify current sun safety knowledge
and behaviors among students; and (2) Teacher questionnaire for
measuring their receptivity to the educational component of the
Program. The data will be analyzed and results will indicate the
Program's effect on participants' sun-protection attitudes and
behaviors. Additionally, information is collected when educators sign
up to receive a Tool Kit either on the Web or in person, and when
individuals participate in an on-line sun safety tutorial/certification
program. Responses to the collection of information are voluntary. All
responses to the collection of information remain anonymous and
confidential.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average .33
hours per response for the survey, .17 hours per response for the
registration, and .02 hours per response for the tutorial/
certification. For the survey, it is estimated that a total of 1,333
burden hours from 4,000 respondents will be valued at $26,510.13 per
year. For the registration, it is estimated that a total of 595 burden
hours from 3,500 respondents will be valued at $45,820.95 per year. For
the tutorial/certification, it is estimated that a total of 22 burden
hours from 1,100 respondents will be valued at $1,540.02 per year.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 8,600.
    Frequency of response: Once per year.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 1,950.
    Estimated total annual costs: $73,871.10. This includes an
estimated burden cost of $73,871.10 and an estimated cost of $0 for
capital investment or maintenance and operational costs.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.

Are There Changes in the Estimates From the Last Approval?

    There is an increase of 117 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. Part of this increase (95 hours) reflects EPA's updating of burden
estimates for this collection based upon historical

registration information. Additionally, EPA is adding a new component
to this ICR, the tutorial/certification program, and will add an
additional 22 burden hours to collect some basic information.

What Is the Next Step in the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
technical person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: February 5, 2007.
Drusilla Hufford,
Director, Stratospheric Protection Division, Office of Air and
Radiation, U.S. Environmental Protection Agency.
 [FR Doc. E7-2308 Filed 2-9-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: April 18, 2007 (Volume 72, Number 74)]
[Notices]
[Page 19494-19499]
[DOCID:fr18ap07-52]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-0326; FRL-8301-5]

Proposed Approval of the Central Characterization Project's
Transuranic Waste Characterization Program at Los Alamos National
Laboratory

AGENCY: Environmental Protection Agency.

ACTION: Notice of availability; opening of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA or we) is announcing
the availability of, and soliciting public comments for 30 days on, the
proposed approval of the radioactive, transuranic (TRU) waste
characterization program implemented by the Central Characterization
Project (CCP) at Los Alamos National Laboratory (LANL). This waste is
intended for disposal at the Waste Isolation Pilot Plant (WIPP) in New
Mexico. In accordance with the WIPP Compliance Criteria, EPA evaluated
LANL-CCP's characterization of contact-handled TRU debris and solid
waste during an inspection conducted May 23-25, 2006, as well as during
follow-up inspections on August 22, 2006, and March 6, 2007. Using the
systems and processes developed as part of the Department of Energy's
(DOE's) Carlsbad Field Office (CBFO), EPA verified whether DOE could
adequately characterize TRU waste consistent with the Compliance
Criteria. The results of EPA's evaluation of the LANL-CCP program and
the proposed approval are described in EPA's inspection report, which
is available for review in the public dockets listed in ADDRESSES. We
will consider public comments received on or before the due date
mentioned in DATES.
    This notice summarizes the waste characterization processes
evaluated by EPA and EPA's proposed approval. As required by the 40 CFR
194.8, at the end of a 30-day comment period EPA will evaluate public
comments received, finalize the report responding to the relevant
public comments, and issue the final report and an approval letter to
DOE's CBFO. Based on previous EPA inspections and approvals, LANL-CCP
is currently approved to dispose of debris and solid waste at WIPP.
LANL-CCP is permitted to continue waste characterization and disposal
in accordance with prior site approvals while EPA establishes a
baseline approval.

DATES: Comments must be received on or before May 18, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0326, by one of the following methods:
     http://regulations.gov: Follow the on-line instructions

for submitting comments.
     E-mail: to<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    Instructions: Direct your comments to Attn: Docket ID No. EPA-HQ-
OAR-2007-0326. The Agency's policy is that all comments received will
be included in the public docket without change and may be made
available online at http://regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://regulations.gov or e-mail. The http://regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm    Docket: All documents in the docket are listed in the http://.

regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://regulations.gov or in hard copy at the Air and Radiation

Docket in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air
and Radiation Docket is<PHONE_NUMBER>. These documents are also
available for review in hard-copy form at the following three EPA WIPP
informational docket locations in New Mexico: in Carlsbad at the
Municipal Library, Hours: Monday-Thursday, 10 a.m.-9 p.m., Friday-
Saturday, 10 a.m.-6 p.m., and Sunday, 1 p.m.-5 p.m., phone number: 505-
885-0731; in Albuquerque at the Government Publications Department,
Zimmerman Library, University of New Mexico, Hours: vary by semester,
phone number:<PHONE_NUMBER>; and in Santa Fe at the New Mexico State
Library, Hours: Monday-Friday, 9 a.m.-5 p.m., phone number: 505-476-
9700. As provided in EPA's regulations at 40 CFR Part 2, and in
accordance with normal EPA docket procedures, if copies of any docket
materials are requested, a reasonable fee may be charged for
photocopying.

FOR FURTHER INFORMATION CONTACT: Rajani Joglekar, Radiation Protection
Division, Center for Federal Regulations, Mail Code 6608J, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    DOE is developing the WIPP near Carlsbad in southeastern New Mexico
as a deep geologic repository for disposal of TRU radioactive waste. As
defined by the WIPP Land Withdrawal Act (LWA) of 1992 (Pub. L. 102-
579), as amended (Pub. L. 104-201), TRU waste consists of materials
containing processes having atomic numbers greater than 92 (with half-
lives greater than twenty years), in concentrations greater than 100
nanocuries of alpha-emitting TRU isotopes per gram of waste. Much of
the existing TRU waste consists of items contaminated during the
production of nuclear weapons, such as rags, equipment, tools, and
sludges.
    On May 13, 1998, EPA announced its final compliance certification
decision to the Secretary of Energy (published May 18, 1998, 63 FR
27354). This decision stated that the WIPP will comply with EPA's
radioactive waste disposal regulations at 40 CFR Part 191, Subparts B
and C.
    The final WIPP certification decision includes conditions that (1)
prohibit shipment of TRU waste for disposal at WIPP from any site other
than the Los Alamos National Laboratories (LANL) until the EPA
determines that the site has established and executed a quality
assurance program, in accordance with Sec. Sec.  194.22(a)(2)(i),
194.24(c)(3), and 194.24(c)(5) for waste characterization activities
and assumptions (Condition 2 of Appendix A to 40 CFR part 194); and (2)
(with the exception of specific, limited waste streams and equipment at
LANL) prohibit shipment of TRU waste for disposal at WIPP (from LANL or
any other site) until EPA has approved the procedures developed to
comply with the waste characterization requirements of Sec.
194.22(c)(4) (Condition 3 of Appendix A to 40 CFR Part 194). The EPA's
approval process for waste generator sites is described in Sec.  194.8.
    In July 2004, EPA promulgated changes to the ``Criteria for the
Certification and Recertification of the Waste Isolation Pilot Plant's
Compliance with Disposal Regulations'' (69 FR 42571-42583, July 16,
2004). These changes went into effect October 14, 2004, which modified
the EPA approval of waste characterization (``WC'') programs at DOE's
TRU waste sites. These revisions provide equivalent or improved
oversight and better prioritization of technical issues in EPA
inspections to evaluate WC activities at DOE WIPP waste generator
sites, and also offer more direct public input into the Agency's
decisions about what waste can be disposed of at WIPP. They do not
modify the technical approach that EPA has employed since the 1998 WIPP
Certification Decision.
    Condition 3 of the WIPP Certification Decision requires that EPA
conduct independent inspections at DOE's waste generator/storage sites
of their TRU

waste characterization capabilities before approving their program and
the waste for disposal at the WIPP. The revised inspection and approval
process gives EPA greater (a) discretion in establishing technical
priorities, (b) ability to accommodate variation in the site's waste
characterization capabilities, and (c) flexibility in scheduling site
WC inspections. The Sec.  194.8 changes require that EPA conduct a
baseline inspection at every previously approved TRU site (such as
AMWTP/INL). EPA expects that within two years after the effective date
of October 2004 most of the previously approved TRU sites (such as
Hanford, Los Alamos CCP, and Savannah River Site CCP) will undergo EPA
baseline inspections. Following these inspections, the Agency will
issue a new baseline compliance decision for these sites.
    As part of the baseline inspection, EPA must evaluate each WC
process component (equipment, procedures, and personnel training/
experience) for its adequacy and appropriateness in characterizing TRU
waste destined for the disposal at WIPP. During the inspection, the
site demonstrates its capabilities to characterize TRU waste(s) and its
ability to comply with the regulatory limits and tracking requirements
under Sec.  194.24. The baseline inspection can result in approval with
limitations/conditions or may require follow-up inspection(s) before
approval. The approval must specify what subsequent WC program changes
or expansion should be reported to EPA. The Agency is required to
assign Tier 1 (``TI'') and Tier 2 (``T2'') to the reportable changes
depending on their potential impact on data quality. A T1 designation
requires that the site must notify EPA of proposed changes to the
approved components of an individual WC process (such as radioassay
equipment or personnel), and EPA must also approve the change before it
can be implemented. A WC element with a T2 designation allows the site
to implement changes to the approved components of individual WC
processes (such as visual examination procedures) but requires EPA
notification. The Agency may choose to inspect the site to evaluate
technical adequacy before approval. EPA inspections conducted to
evaluate T1 or T2 changes are follow-up inspections under the authority
of Sec.  194.24(h). In addition to the follow-up inspections, if
warranted, EPA may opt to conduct continued compliance inspections at
TRU waste sites with a baseline approval under the authority of Sec.
194.24(h).
    The revisions to the site inspection and approval process outlined
in Sec.  194.8 require EPA to issue a Federal Register notice proposing
the baseline compliance decision, docket the inspection report for
public review, and seek public comment on the proposed decision for a
period of 30 days. The report must describe the WC processes EPA
inspected at the site, as well as their compliance with Sec.  194.24
requirements.

III. Proposed Baseline Compliance Decision

    In accordance with 40 CFR 194.8(b), EPA conducted a baseline
inspection of the CCP's waste characterization program at LANL in Los
Alamos, New Mexico. This inspection occurred on May 23-25, 2006, with a
follow-up inspection of the visual examination (VE) process related to
the sealed sources program conducted on August 22, 2006. On March 6,
2007, the Agency also performed an on-site follow-up evaluation at LANL
to verify the resolution of all open EPA issues. (All three inspections
are grouped under EPA Baseline Inspection No. LANL-CCP-05.06-8).
    The CCP is a mobile characterization program that assists TRU waste
generator sites with complex waste characterization activities. At some
sites (such as LANL and Savannah River Site) and small TRU waste
generator sites (such as Argonne National Laboratory and Lawrence
Livermore National Laboratory) the CCP has the sole responsibility to
characterize contact-handled (CH), retrievably-stored TRU waste
destined for the disposal at the WIPP.
    The purpose of EPA's inspection was to verify that LANL-CCP is
characterizing CH TRU retrievably-stored debris waste (S5000) and solid
waste (S3000), properly and in compliance with the regulatory
requirements at 40 CFR 194.24. EPA also evaluated characterization of
sealed sources collected and repackaged as part of the Offsite Source
Recovery Program (OSRP) at LANL as a CH TRU newly-generated debris
waste. During the inspection, EPA also evaluated LANL-CCP's use of the
WIPP Waste Information System (WWIS) for tracking the contents of CH
TRU waste containers destined for disposal at WIPP. This tracking
ensures that the volume emplaced in the WIPP repository and
characteristics of the emplaced wastes conform to the requirements of
the WIPP LWA and the specific conditions of the WIPP Certification
Decision.
    During the inspection, EPA evaluated the adequacy, implementation,
and effectiveness of LANL-CCP's waste characterization activities. The
Agency's evaluation focused on the individual components--equipment,
procedures, and personnel training/experience of the following waste
characterization processes: Acceptable knowledge (AK), nondestructive
assay (NDA), visual examination techniques (VET), visual examination/
real-time radiography (VE/RTR), load management, and the WWIS. The
overall program adequacy and effectiveness of LANL-CCP was based on the
following DOE-provided upper-tier documents: (1) CCP-PO-001--Revision
13, 11/16/06--CCP Transuranic Waste Characterization Quality Assurance
Project Plan and (2) CCP-PO-002--Revision 18, 11/16/06--CCP Transuranic
Waste Certification Plan.
    EPA previously evaluated and approved WC systems at LANL, most
recently in April 2005 (EPA Docket No. A-98-49, II-A4-57). LANL
received approval to dispose of contact handled, retrievably-stored
debris (S5000) and solid waste (S3000), and repackaged sealed sources
as newly-generated debris waste prior to this baseline inspection. The
purpose of the LANL-CCP baseline and follow-up inspections was to
evaluate the adequacy of the site's WC programs for two TRU waste
categories--debris and solids--to be disposed of at the WIPP; the
debris included sealed sources from the OSRP. During the inspections,
the Agency examined the following activities:
     Acceptable knowledge (AK) and load management for contact-
handled (CH) retrievably-stored TRU debris waste (S5000) and solid
waste (S3000) and AK for CH newly-generated, repackaged debris waste
from the OSRP.
     Visual examination (VE) as a quality control (QC) check of
real-time radiography (RTR) and in lieu of RTR for CH retrievably-
stored TRU debris waste (S5000) and solid waste (S3000) and Visual
Examination Technique (VET) for CH newly-generated, repackaged debris
waste from the OSRP.
     RTR for CH retrievably-stored TRU debris waste (S5000) and
solid waste (S3000).
     Nondestructive assay (NDA), specifically, three NDA
systems--LANL HENC 1 and LANL HENC 2 for
characterizing debris (S5000) and solid (S3000) waste, respectively,
and the portable tomographic gamma scanner

(PTGS) for characterizing debris waste (S5000) \1\ only.
---------------------------------------------------------------------------

    \1\ NDA systems are typically not matrix-specific in the same
manner as other characterization techniques and their approval is
not tied to specific waste matrix categories (i.e., S3000 or S5000).
Specifically, virtually any material within the system's matrix
calibration range may be assayed.
---------------------------------------------------------------------------

     WIPP Waste Information System (WWIS) for CH retrievably-
stored TRU debris waste (S5000) and solid waste (S3000).
    In addition to reviewing individual components (namely, procedures,
and equipment) of each of the WC processes (AK, NDA, VET, VE/RTR, load
management, and the WWIS), the Agency interviewed and reviewed training
records of personnel responsible for compiling data, analyzing waste
contents, operating equipment, and preparing data for WWIS tracking.
EPA also required radioassay replicate analysis on selected containers
from the population of previously analyzed waste containers on the same
system or instrument for the two different waste categories. The
purpose of this replicate testing is to provide EPA with an independent
means to verify that the radioassay equipment being assessed for
approval can provide consistent, reproducible results for the
determination of the quantity of 10 WIPP-tracked radionuclides (241Am,
137Cs, 238Pu, 239Pu, 240Pu, 242Pu, 90Sr, 233U, 234U, and 238U) as well
as TRU alpha concentration. The results of the replicate analysis help
EPA to determine whether:
     The instrument produces results consistent with the
reported total measurement uncertainty (TMU) by comparing the sample
standard deviation for a number of replicate measurements taken over
several hours or days to the reported TMU.
     The instrument provides reproducible results over longer
periods of time, such as weeks or months, by comparing the results of
the replicate measurement(s) to the original reported values.
    The EPA inspection team identified one finding and seven concerns.
The finding in the area of VE and five of the concerns required a
response from DOE, while two concerns did not require a response. EPA
Inspection Issue Tracking Forms (see Attachments C.1 through C.8 to the
proposed baseline inspection report) document the finding and seven
concerns. Personnel from LANL, CBFO, and CCP provided information on
resolutions for the finding and concerns to the EPA inspection team
prior to the closeout of the onsite inspection and after the
inspection. The information provided by CBFO addressed the one finding
and the concerns that required a response, as well as the two concerns
that did not require a response. Between May 2006 and March 2007, CCP
provided satisfactory resolution addressing three concerns while one
finding and three concerns remained unresolved. At the follow-up
inspection on March 6, 2007, CCP discussed with the EPA inspection team
their responses for the four outstanding issues that EPA evaluated for
completeness and adequacy, and concluded that each had been resolved
satisfactorily. EPA considers the one finding and all concerns to be
resolved, and there are no open issues resulting from this inspection.
    The EPA inspection team determined that the LANL-CCP WC program
activities were technically adequate. EPA is proposing to approve the
LANL-CCP WC program in the configuration observed during this
inspection and described in this report and the checklists included in
the proposed baseline inspection report (Report Attachments A.1 through
A.8). This proposed approval includes the following:
    (1) The AK and load management process for CH retrievably-stored
TRU debris and solid wastes and for newly-generated debris wastes from
the OSRP.
    (2) The LANL HENC 1 and LANL HENC 2 NDA systems
for assaying solid and debris wastes.
    (3) The PTGS NDA system for assaying debris waste.
    (4) VE as a QC check of the RTR process and in lieu of the RTR
process for retrievably-stored solid and debris wastes and VET of
newly-generated debris wastes from the OSRP.
    (5) The nondestructive examination process of RTR for retrievably-
stored solid and debris wastes.
    (6) The WWIS process for tracking of waste contents of solid and
debris wastes, including debris from the OSRP.
    LANL-CCP must report and, if applicable, receive EPA approval of
any changes to the WC activities from the date of the baseline
inspection, according to Table 1, below. Table 1 in this report is not
identical to those included in previous baseline inspection reports and
EPA site approval letters in several ways. The most important of these
involve presentation of the Tier 2 (T2) elements. In previous reports
there were two T2 columns that have been merged into a single T2 column
for LANL-CCP. The T2 column entries have also been modified to better
reflect the 40 CFR 194.24 (h) requirements that the site provide
notification regarding the completion or availability of specific T2
elements, whereas the previous tables stated that the site must
actually provide the T2 elements (document or procedure revisions,
etc.). This approach is similar to the tiering tables used in EPA
reports for sites characterizing remote handled TRU waste.
Additionally, there are other minor word changes to the table for the
sake of legibility.
    There are changes to specific WC areas as well. For AK, the AK
Reassessment Memoranda (reflecting resolution to concern LANL-CCP-AK-
06-001CR) and the AK-VE Memoranda related to VE cited under T2 changes
(reflecting resolution to finding LANL-CCP-VE-06-004F) do not appear in
the tiering tables in previous baseline inspection reports. Similarly,
requesting revisions to CCP-AK-008 or notification regarding the
combination of waste streams that were distinct at the time of
inspection are specific to the LANL OSRP or the result of information
identified during this inspection. Accordingly, these are absent from
the tiering tables in previous baseline inspection reports. For WWIS,
changes to specific process elements (e.g., spreadsheets and data
fields) are cited as T2 changes and these did not appear in previous
tiering tables. These were added to provide a greater degree of
specificity in an attempt to identify and focus on the key elements
relevant to waste isolation.
    The table below summarizes EPA's proposed tiering for LANL-CCP. As
described previously, T1 changes require EPA approval prior to
implementation of the change and may require EPA inspection to
determine technical adequacy. T2 changes may be implemented prior to
EPA approval; however, this type of change must be reported to EPA
quarterly. Any changes to WC activities from the date of the baseline
inspection must be reported to and, if applicable, approved by EPA,
according to the following table:

 Table 1.--Tiering of TRU WC Processes Implemented by LANL-CCP Based on
    May 23-25, 2006 On Site Baseline Inspection, August 22, 2006 OSRP
                 Inspection and March 6, 2007 Evaluation
------------------------------------------------------------------------
                                 LANL-CCP WC T1        LANL-CCP WC T2
     WC process elements             changes              changes*
------------------------------------------------------------------------
Acceptable Knowledge (AK)     Any new waste         Notification to EPA
 and Load Management.          category, or new      upon completion of
                               OSRP wastes           AK Accuracy
                               addressed in AK       Reports; AK (2).
                               Summaries separate   Notification to EPA
                               from CCP-AK-008; AK   upon completion of
                               (3), AK (6), AK       updates to or
                               (16) and (AK) 17.     substantive
                              Implementation of      modifications of
                               Load Management for   the following:
                               waste streams other  --AK Reassessment
                               than AK-009; AK       Memoranda; AK (1)
                               (5)..                 and AK (6).
                                                    --AK-VE Memoranda
                                                     related to VE and/
                                                     or RTR techniques;
                                                     AK (2).
                                                    3--AK-NDA Memoranda;
                                                     AK (3).
                                                       --Site procedures
                                                        requiring CBFO
                                                        approval; AK
                                                        (4).
                                                       --AK Summary CCP-
                                                        AK-008, if
                                                        changed to
                                                        include newly
                                                        approved \239\Pu
                                                        and \241\Am
                                                        sealed sources
                                                        and/or
                                                        irradiated
                                                        sources; AK (6).
                                                       --Combination of
                                                        waste streams
                                                        that were
                                                        distinct at the
                                                        time of this
                                                        inspection; AK
                                                        (6).
                                                       --Change Notices
                                                        used to modify
                                                        and update
                                                        WSPFs, including
                                                        additions to
                                                        waste stream(s)
                                                        within an
                                                        approved waste
                                                        category; AK
                                                        (9).
Nondestructive Assay (NDA)..  New equipment or      Notification to EPA
                               physical              upon completion of
                               modifications to      changes to software
                               approved              for approved
                               equipment**; NDA      equipment,
                               (1).                  operating range(s)
                              Extension or changes   and site procedures
                               to approved           that require CBFO
                               calibration range     approval; NDA (2).
                               for approved
                               equipment; NDA (2)..
Real-Time Radiography (RTR).  N/A.................  Notification to EPA
                                                     upon the following:
                                                    --Implementation of
                                                     new equipment or
                                                     substantive changes
                                                     to approved
                                                     equipment; RTR (1).
                                                    --Completion of
                                                     changes to site
                                                     procedures
                                                     requiring CBFO
                                                     approvals; RTR (2).
Visual Examination (VE) and   N/A.................  Notification to EPA
 Visual Examination                                  upon the following:
 Technique (VET), including                         --Completion of
 OSRP Wastes (Sealed Source                          changes to site VE
 VET or SSVET).                                      and VET procedures
                                                     requiring CBFO
                                                     approvals,
                                                     including OSRP VET
                                                     procedure; VE (1)
                                                     and SSVET (1).
WIPP Waste Information        N/A.................  Notification to EPA
 System (WWIS).                                      upon the following:
                                                    --Completion of
                                                     changes to WWIS
                                                     procedure(s)
                                                     requiring CBFO
                                                     approvals; WWIS (1)
                                                     and WWIS (2).
                                                       --Changes to the
                                                        Excel
                                                        spreadsheet,
                                                        WWIS data entry
                                                        summary,
                                                        characterization
                                                        and
                                                        certification;
                                                        WWIS (1) and
                                                        WWIS (2).
------------------------------------------------------------------------
* Upon receiving EPA approval, LANL-CCP will report all T2 changes to
  EPA at the end of each fiscal year quarter.
** Modifications to approved equipment include all changes with the
  potential to affect NDA data relative to waste isolation and exclude
  minor changes, such as the addition of safety-related equipment.

    EPA will notify the public of the results of its evaluations of
proposed Tier 1 (T1) and T2 changes through postings to the EPA WIPP
Web site and by sending e-mails to the WIPP-NEWS listserv (see Section
2.0 of this report for a brief discussion of tiering). All T1 changes
must be submitted for evaluation and approval by EPA before their
implementation. Upon approval, EPA will post the results of the
evaluations through the EPA Web site and the WIPPNEWS list, as
described above. Upon completion of its review of the T2 changes
submitted at the end of each fiscal quarter, EPA will post the T2
changes. EPA expects the first report of LANL-CCP's T2 changes at the
end of the fourth quarter FY 2007.
    The scope of the site baseline compliance decision is based on
EPA's inspections completed on May 25, 2006, and August 22, 2006, and
the follow-up evaluation conducted on March 6, 2007.

IV. Availability of the Baseline Inspection Report for Public Comment

    EPA has placed the report discussing the results of EPA's
inspection of the CCP waste characterization program at LANL in the
public docket as described in ADDRESSES. In accordance with 40 CFR
194.8, EPA is providing the public 30 days to comment on these
documents. The Agency requests comments on the tiering designations and
the proposed approval decision. EPA will accept public comment on this
notice and supplemental information as described in Section 1.B. above.
The EPA will not make a determination of compliance before the 30-day
comment period ends. At the end of the public comment period, EPA will
evaluate all relevant public comment and revise the inspection report
as necessary. The Agency will then issue an approval letter and the
final inspection report,

both of which will be posted on the WIPP Web site. The letter of
approval will allow CCP to use the approved TRU waste characterization
processes to characterize waste at LANL.
    Information on the certification decision is filed in the official
EPA Air Docket, Docket No. A-93-02 and is available for review in
Washington, DC, and at the three EPA WIPP informational docket
locations in New Mexico (as listed in ADDRESSES). The dockets in New
Mexico contain only major items from the official Air Docket in
Washington, DC, plus those documents added to the official Air Docket
since the October 1992 enactment of the WIPP LWA.

    Dated: April 11, 2007.
Elizabeth Cotsworth,
Director, Office of Radiation and Indoor Air.
 [FR Doc. E7-7349 Filed 4-17-07; 8:45 am]

BILLING CODE 6560-50-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007) >

<EPA Registration Division contact: [insert name and telephone number with area code] >

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

<TEMPLATE: >

<Bayer CropScience >

< [Insert petition number] >

<	EPA has received a pesticide petition ([insert petition number]) from Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC  27709 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180. >

< (Options (pick one) >

<	1. by establishing tolerances and/or changing existing tolerances for residues of>

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

<	trifloxystrobin (benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its acid metabolite CGA–321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxym ethyl]-phenyl]acetic acid) in or on the raw agricultural commodity [alfalfa, forage] at 0.01 parts per million (ppm) and  [alfalfa, hay] at 0.01 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. >

<A. Residue Chemistry>

<	1. Plant metabolism.   SEQ CHAPTER \h \r 1 The metabolism of trifloxystrobin in plants (cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals (goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA-321113 are the residue of concern for tolerance setting purposes. >

<	2. Analytical method.   SEQ CHAPTER \h \r 1 A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection (LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen-phosphorus detection.  A newer analytical method is available employing identical solvent mixtures and solvent to matrix ratio (as the first method), deuterated internal standards, and liquid chromatography/mass spectrometry-mass spectrometry (LC/MS-MS) with an electrospray interface, operated in the positive ion mode.  The limits of detection (LOD) for trifloxystrobin range from 0.002 ppm to 0.01 ppm, depending on the crops, and the limit of quantitation is 0.01 ppm. >

<	3. Magnitude of residues.

Alfalfa seed, treated with [benzeneacetic-phenyl-UL-14C] trifloxystrobin at rates of

0.0039 lb. ai/100 lb. seed and 0.0125 lb. ai/100 lb. seed (0.83X the target maximum rate of 0.015 lb. ai/100 lb. seed), was planted, and alfalfa was grown to maturity.

The alfalfa raw agricultural commodity (RAC) of forage was collected from three cuttings at BBCH 61 to 65 (10% flowering to 50% flowering). Additionally, alfalfa hay samples were collected, following drying, from the second and third cuttings.

All RAC samples were homogenized and radioassayed. The limit of quantitation (LOQ) for detection of total radioactive residue from all RACs was 0.0028 ppm. The total radioactive residue (TRR) in both alfalfa forage and hay from seed treated at both application rates was comparable to that of control samples at all three cuttings (net residue <0.0028 ppm).

<B. Toxicological Profile>

<	1. Acute toxicity.  There is a full battery of acute toxicity studies for trifloxystrobin. Trifloxystrobin is of mild acute toxicity by oral, dermal, or inhalation routes of exposure (Cat. IV), however it is a strong dermal sensitizer. Trifloxystrobin is a mild ocular (Cat III) and dermal irritant (Cat IV). >

<	2. Genotoxicty.   SEQ CHAPTER \h \r 1 No genotoxic activity is expected of trifloxystrobin under in-vivo or physiological conditions. The compound has been tested for its potential to induce gene mutation and chromosomal changes in five different test systems. The only positive finding was seen in the in vitro test system (Chinese hamster V79 cells) as a slight increase in mutant frequency at a very narrow range (250 – 278 (g/mL) of cytotoxic and precipitating concentrations (compound solubility in water was reported to be 0.61 (g/mL; precipitate was visually noted in culture medium at 150 (g/mL).  The chemical was found to be non-mutagenic in the in vivo system or all other in vitro systems. Consequently, the limited gene mutation activity in the V79 cell line is considered a nonspecific effect under non-physiological in vitro conditions and not indicative of a real mutagenic hazard. >

<	3. Reproductive and developmental toxicity.   SEQ CHAPTER \h \r 1 In a developmental study in rats, reductions in body weight gain and food consumption were observed in the dams at (100 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increased incidence of enlarged thymus at 1000 mg/kg/day. The developmental NOEL was 1000 mg/kg/day.

750 ppm, especially in females during lactation. Consequently, the reduced pup weight gain during lactation (750 ppm) and the slight delay in eye opening (1500 ppm) are judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted.  The low developmental NOEL, 50 ppm (3.8 mg/kg) seen in this study was probably due to the lack of intermediate dose levels between 50 and 750 ppm. The reproductive NOAEL was 1500 ppm (=110.6 mg/kg/day). >

<	4. Subchronic toxicity.   SEQ CHAPTER \h \r 1 In a subchronic study in rats a NOAEL of 500 ppm (30.6-32.8 mg/kg/day) was found based on decreased body weights (males), hypertrophy of hepatocytes (males), and pancreatic atrophy observed at the LOAEL of 2000 ppm (127-133 mg/kg/day).

In mice, a NOAEL was determined at 500 ppm (76.9-110 mg/kg/day) based on increased liver weights and necrosis of hepatocytes observed at the LOAEL of 2000 ppm (315-425 mg/kg/day).

A subchronic feeding study in dogs resulted in a NOAEL of 30 mg/kg/day. Increased liver weight and hepatocyte hypertrophy in males were observed at the LOAEL of 150 mg/kg/day.

In a 28–day dermal toxicity study in rats the NOAEL was found at 100 mg/kg/day. Increased liver and kidney weight were observed at the LOAEL of 1,000 mg/kg/day. >

<	5. Chronic toxicity. A chronic feeding study in dogs established a no-observed adverse effect level (NOAEL) of 5 mg/kg/day. The lowest effect level (LOAEL) for this study was found at 50 mg/kg/day, based on clinical signs, increased liver weight and hepatocellular hypertrophy.

In a carcinogenicity study in mice liver effects were observed at doses of and above the LOAEL of 1000 ppm (131.1 mg/kg/day). The NOAEL was determined to be 300 ppm (39.4 mg/kg/day).

A chronic toxicity/carcinogenicity study in rats established a NOAEL of 250 ppm (9.81–11.37 mg/kg/day). Decreased mean body weight and decreased mean body weight gain (compared to control) were observed at the LOAEL of 750 ppm (29.7–34.5 mg/kg/day).

The compound did not cause any treatment-related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18-month mouse and the 24-month rat studies.  An ad hoc subcommittee of the Cancer Assessment Review Committee on May 27, 1999 determined that trifloxystrobin should be classified as a "Not Likely Human Carcinogen," based on the lack of evidence for carcinogenicity in rats and mice.  >

<	6. Animal metabolism.   SEQ CHAPTER \h \r 1 Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the elimination half life is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester (hydrolysis into an acid), the methoxyimino group (O-demethylation), and the methyl side chain (oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite (CGA-321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl-phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.  >

<	7. Metabolite toxicology.   SEQ CHAPTER \h \r 1 Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied material remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA-321113 (formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20-times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/or soil. The studies indicate that these metabolites, including CGA-357261, CGA-373466, and NOA-414412, are not mutagenic to bacteria and are of low acute toxicity (LD50 >2000 mg/kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin. >

<	8. Endocrine disruption.   SEQ CHAPTER \h \r 1 Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long-term effect related to the endocrine system. >

<C. Aggregate Exposure>

<	1. Dietary exposure.   SEQ CHAPTER \h \r 1 Assessments, using the DEEM FCID Version 2.0, 1994-1996, 98 CSFII software,  were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population and selected population subgroups to residues of trifloxystrobin.  These analyses cover all registered and pending uses including the proposed use as a seed treatment in alfalfa.

The EPA has established an acute Population Adjusted Dose (aPAD) of 2.5 mg/kg/day for acute dietary risk assessments based on a NOAEL of 250 mg/kg bw/day from a rabbit developmental toxicity study and an uncertainty factor or 100. The FQPA SF was reduced to 1x based on toxicological considerations by the FQPA Safety Factor Committee (HED Doc. No. 013545, B. Tarplee, 01/JUL/1999), the conservative residue assumptions used in the dietary and residential exposure risk assessments, and the completeness of the residue chemistry and environmental fate databases (DP Num: 3 17330, B. O'Keefe,1 6/AUG/2006).  For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose (cPAD) of 0.038 mg/kg/day based on a NOAEL of 3.8 mg/kg bw/day from the rat reproduction toxicity study and an uncertainty factor of 100.

Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U.S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the proposed changes to corn and sweet corn tolerances. >

<	i. Food.    SEQ CHAPTER \h \r 1 For food, a Tier 1 acute and chronic dietary exposure assessments were performed. Acute exposure, expressed at the 95th percentile of exposure, was 1.5 % of the aPAD for Females 13-49 years old (only population subgroup of concern).  The chronic exposure was 36.2 % cPAD for the Total US Population and 69.6 % cPAD for the most sensitive population, Children 1-2 years old. >

<	ii. Drinking water. Acute and chronic exposure estimates from water are included in the exposure values given above for food. These exposure estimates for water are based on EPA’s surface water estimated environmental concentrations (EECs) of trifloxystrobin and CGA-321113 for acute exposure and for chronic exposures at 140 ppb. These values are listed in the Federal Register (71 FR 55313). >

<	2. Non-dietary exposure. There is no potential for dermal or incidental oral exposure during or post application of trifloxystrobin when applied as a seed dressing to alfalfa.   As such, non-dietary exposure from these new tolerances are covered by previous non-dietary risk assessments performed by EPA.   SEQ CHAPTER \h \r 1 As published in the Federal Register (FR Vol 68, no. 175, 10-Sep-03, FR Vol 73, no. 1, 02-Jan-08), the EPA considered chronic, short term and intermediate term risk from residential uses of trifloxystrobin. The EPA determined that the risk did not exceed the Agency’s level of concern. >

<D. Cumulative Effects>

˜

š

B*

B*

B*

B*

ᔦꩨ홷ᘀ쩨၏㔀脈⩂䌋ᡊ尀脈࡝憁ᡊ瀀hᤀ

&

'

-

‰

ᘀ¾

À

Â

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

hÎ

B*

# h

h

B*

h

B*

# h

B*

B*

B*

B*

B*

B*

hÎ

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

hÎ

B*

B*

B*

B*

B*

B*

B*

옍)

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

under Aggregate Exposure, there is reasonable certainty that exposure from trifloxystrobin will result in no harm to the adult U.S. population. >

<	2. Infants and children. Based on the information supplied above under Aggregate Exposure, there is reasonable certainty that exposure from trifloxystrobin will result in no harm to the infants and children. >

<F. International Tolerances>

<	International tolerances and CODEX tolerances for trifloxystrobin are established for many crops in various countries. No tolerances exist yet in Canada or Mexico for the new proposed uses. >

 PAGE

 PAGE   6