[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Proposed Rules]
[Pages 41341-41344]
[FR Doc No: 2023-13524]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2020-0699; FRL-10754-01-R5]

Air Plan Approval; Indiana; ArcelorMittal and NIPSCO Sulfur
Dioxide Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the sulfur dioxide (SO2) portion of the
Indiana State Implementation Plan (SIP). The state of Indiana is
requesting revisions to emission limits at the Northern Indiana Public
Service Company Bailly Station (NIPSCO) facility reflecting permanently
shut down units. Indiana is also requesting SIP revisions for two
facilities formerly owned by ArcelorMittal USA LLC and currently owned
by Cleveland-Cliffs LLC (Indiana Harbor East and Indiana Harbor West).
The Indiana Harbor East facility is required to demonstrate continuous
compliance with final SO2 emission limits as a daily (24-
hour) average. These revisions will result in decreases in allowable
SO2 emissions at all three facilities, maintaining
SO2 attainment/unclassifiable designations for the 2010 1-
hour SO2 national ambient air quality standards (NAAQS).

DATES: Comments must be received on or before July 26, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2020-0699 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Cecilia Magos, Life Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected]. The EPA Region 5 office is open from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding Federal holidays and
facility closures due to COVID-19.

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background

    On March 31, 2021, the Indiana Department of Environmental
Management (IDEM) submitted a site-specific SO2 SIP revision
request to EPA for the NIPSCO facility in Porter County, and SIP
revision requests for Indiana Harbor West and Indiana Harbor East both
located in Lake County. The revisions for NIPSCO and ArcelorMittal LLC
(Indiana Harbor West) are administrative clean-up revisions removing
limits that apply to permanently shut down units. The revisions for
ArcelorMittal LLC (Indiana Harbor East) remove limits that apply to
permanently shut down units and include a demonstration of continuous
compliance with SO2 emission limits as a daily (24-hour)
average SO2 pounds per hour (lbs/hr) emission limit.

II. Content in IDEM's SIP Revision Request

    The revised rule 326 Indiana Administrative Code (IAC) 7-4-14(2)
reduces the SO2 emissions at the NIPSCO facility by removing
boilers 7 and 8 and their limits of 6.0 pounds per million British
thermal units (lbs/MMBtu) each, described in Table 1 below. These
boilers have been permanently shut down.
    Additionally, revisions to 326 IAC 7-4.1-10 update the name of the
ISG Indiana Harbor Inc. facility to ArcelorMittal USA LLC (Indiana
Harbor West). The revised rule changes language of Utility Boilers 5,
6, 7 and 8 emission unit requirements from ``shall'' to ``must''
concerning total actual heat input from fuel oil usage at all boilers
combined, the fuel boilers are fired on, and sulfur percentage and lb/
MMBtu of fuel oil burned. For shut down units, the revision includes
removal of the hot strip mill slab heat reheat furnaces 1, 2, and 3
with emission limits of 531.1 lbs/hr each, as well as removal of the
sinter plant windbox with emission limits of 240 lbs/hour. Removal of
emission units and limits results in a total of 19.67 lbs/hour sulfur
emission limit reductions at the Indiana Harbor West facility.
    Rule revisions to 326 IAC 7-4.1-11 update the name of the Ispat
Inland Inc. facility to ArcelorMittal USA LLC (Indiana Harbor East).
The revisions include removal of a series of shut down emission units
and listings including: No. 1 blast furnace stove; No. 2 blast furnace
stove; No. 5 and No. 6 blast furnace stoves; No. 2AC boilers 207, 208,
209, and 210; No. 2AC boilers 211, 212, and 213; No. 4AC boilers 401,
402, 403, 404, and 405; stack 1 (boilers 401 and 402); stack 2 (boilers
403 and 404); stack 3 (boiler 405); anneal 3, 4. In regard to the
boilers that feed into stacks 1, 2, and 3 being shut down, the SIP
revision removes the requirements to operate continuous emission
monitoring systems on those stacks. The SIP revision also removes the
equations to calculate sulfur dioxide emissions in units of pounds per
MMBtu of the aforementioned units.
    For the Indiana Harbor East facility, the revised rule at 326 IAC
7-4.1-11 combines the No. 7 Blast Furnace Canopy and No. 7 Blast
Furnace Baghouse into a combined No. 7 Blast

Furnace West Baghouse and East Baghouse which must demonstrate
compliance with an SO2 emission limit of 432 lbs/hr. The SIP
revision also removes the EAF shop ladle metal baghouse and its
emission limits.
    The revised rule 326 IAC 7-4.1-11 requires continuous compliance
with final SO2 emissions limits as a daily (24-hr) average
SO2 emission limit at the Indiana Harbor East facility.
Hourly SO2 emission rates (in pounds of SO2 per
MMBtu or ton) will be calculated by dividing total daily SO2
emissions in pounds per day by total heat input per day in MMBtu or
ton, respectively, for emission units with pounds of SO2 per
MMBtu limit. Table 1 shows the emission limit changes at all three
facilities.

   Table 1--Emission Limit Changes and Closures at NIPSCO Facility, Indiana Harbor West Facility, and Indiana
                                              Harbor East Facility
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              Unit name                              Former limit                         Revised limit
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                          North Indiana Public Service Company Bailly Station (NIPSCO)
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Boilers 7 and 8......................  6.00 lbs/MMBtu each....................  0.0 lb/hr.
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                                   ArcelorMittal USA LLC (Indiana Harbor West)
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Hot Strip Mill Slab Heat Reheat        535.1 lbs/hr each......................  0.0 lbs/hr each.
 Furnaces 1, 2, and 3.
Sinter Plant Windbox.................  240 lbs/hr.............................  0.0 lbs/hr.
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                                   ArcelorMittal USA LLC (Indiana Harbor East)
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No. 1 Blast Furnace Stoves...........  11.92 lbs/hr total.....................  0.0 lbs/hr.
No. 2 Blast Furnace Stoves...........  12.4 lbs/hr total......................  0.0 lbs/hr
No. 5 and 6 Blast Furnace Stoves.....  41.02 lbs/hr each......................  0.0 lbs/hr.
No. 2AC Boilers 207, 208, 209, and     15.873 lbs/hr total....................  0.0 lbs/hr.
 210.
No. 2AC Boilers 211, 212, and 213....  168.0 lbs/hr total.....................  0.0 lbs/hr.
No. 4AC Boilers 401, 402, 403, 404,    890.23 lbs/hr total....................  0.0 lbs/hr.
 and 405.
Anneal 3, 4..........................  0.0 lbs/hr.............................  0.0 lbs/hr.
EAF Shop Ladle Metal Baghouse........  13.90 lbs/hr...........................  0.0 lbs/hr.
No.7 Blast Furnace West Baghouse and   50.400 lbs/hr..........................  432 lbs/hr total.
 East Baghouse.
No. 7 BF Casthouse Baghouse..........  50.400 lbs/hr..........................  0.0 lbs/hr.
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III. Clean Air Act Section 110(1)

    Section 110(l) of the Clean Air Act (CAA) provides that state
submissions cannot be approved as SIP revisions if they interfere with
applicable requirements concerning attainment and maintenance of the
NAAQS, reasonable further progress, or any other applicable requirement
of the CAA. The relevant NIPSCO facility is located in Porter County
which was designated as attainment/unclassifiable during Round 4
designations for the 2010 SO2 standard (86 FR 16055, March
26, 2021). The ArcelorMittal USA LLC facilities, Indiana Harbor East
and Indiana Harbor West, are located in Lake County which was
designated attainment/unclassifiable during Round 3 designations for
the 2010 SO2 standard (83 FR 1098, January 9, 2018). EPA
finds that Indiana's revision to the rules at 326 IAC 7-4-14(2)
(NIPSCO), 326 IAC 7-4.1-10 (Indiana Harbor West), and 326 IAC 7-4.1-11
(Indiana Harbor East), reflecting SO2 emission limits
revisions and emission unit removals, will not interfere with
attainment and maintenance of the NAAQS, reasonable further progress,
or any other applicable requirement of the CAA, nor pose a risk to the
permanence and compliance with SO2 attainment/unclassifiable
designations in Porter and Lake Counties.
    EPA is proposing that the overall revisions in allowable
SO2 emissions in IDEM's March 31, 2021, revised rule 326 IAC
7-4-14(2) further reduces SO2 emissions in Porter County by
removal of Boilers 7 and 8 at the NIPSCO facility, resulting in a total
of 12 lbs/MMBtu emission limit reduction.
    Revisions to the 326 IAC 7-4.1-10 rule applicable to the Indiana
Harbor West facility in Lake County also reduces SO2
emissions by a total 19.67 lbs/hr by removal of hot strip mill slab
heat reheat furnace 1,2, and 3 and the removal of the sinter plant
windbox at the facility, further strengthening the SIP.
    EPA's analysis found that revisions to 326 IAC 7-4.1-11 applicable
to the Indiana Harbor East facility in Lake County will reduce
SO2 emissions by 770.13 lbs/hr of SO2 (see
Indiana-ArcelorMittal USA LLC.xlsx, sheet IHE in the docket for this
action). The No. 7 blast furnace previous emission limit was set to
50.400 lbs/hour and was revised by the State to 432.00 lbs/hr as shown
in Table 1. As a result, the revisions to the now combined No. 7 blast
furnace west baghouse and east baghouse increased emissions by 381.60
lbs/hr total in relation to the original permitted amount. The
summation of the facility's existing units daily (24-hour) averaged
SO2 emission limits is 1,236.00 SO2 lbs/hr. To
calculate a comparatively stringent 1-hour emission rate for the
longer-term averaged units at the facility, EPA is utilizing a 99th
percentile 24-hour average SO2 emission adjustment of 0.93
listed in EPA's April 2014 Guidance for 1-hour SO2 Nonattainment Area
SIP Submissions 1 for uncontrolled units averaged over a 24-
hour basis. The existing limit rate of 1,236.00 SO2 lbs/hr
over a 24-hour average results in a comparably stringent 1-hour
emission rate of 1,329.03 SO2 lbs/hr after application of
the 0.93 adjustment factor, an increase of 93.03 lbs/hr. The sum of the
increase of emission limits at the facility equals 474.63
SO2 lbs/hr and the sum of the decrease of emission limits at
the facility equals 1,244.76 SO2 lbs/hr. Therefore, the
revisions result in an overall 770.13 SO2 lbs/hr net
reduction in SO2 emission limits at the facility. Based on
the above, EPA proposes to find that IDEM's March 31, 2021, submittal
is consistent with CAA section 110(l).
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    \1\ https://www.epa.gov/so2-pollution/guidance-1-hour-sulfur-dioxide-so2-nonattainment-area-state-implementation-plans-sip (pages
22-39).

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IV. Environmental Justice Considerations

    EPA identified environmental burdens and susceptible populations in
communities nearby, by performing a screening-level analysis using the
EPA's environmental justice (EJ) screening and mapping tool
(``EJSCREEN'').\2\ The EJSCREEN analysis reports are included in the
docket for this action for the NIPSCO and ArcelorMittal USA LLC
(Indiana Harbor West and Indiana Harbor East) facilities located in
Porter County and Lake County, respectively.
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    \2\ See documentation on EPA's Environmental Justice Screening
and Mapping Tool at https://www.epa.gov/ejscreen, last accessed 1/
18/2022.
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    EPA utilized the EJSCREEN tool to evaluate environmental and
demographic indicators within a 1-mile and 3-mile radius of the NIPSCO
facility in Porter County. The 1-mile buffer showed no census data
within the area, indicating no individuals live within one mile of the
facility. Thus, to further evaluate environmental and demographic
indicators of the facility with available census data, an additional
analysis was conducted at a 3-mile buffer. For the 3-mile buffer, EPA
reviewed the EJSCREEN tool for the demographic indicators at the NIPSCO
facility, specifically for the EJSCREEN ``Demographic Index'', which is
the average of an area's percentage of people of color and percentage
of low-income populations. EPA then compared the data to the national
Demographic Index average. The results of this analysis are being
provided for informational and transparency purposes. The results of
the demographic analysis indicate that the Demographic Index at the
NIPSCO location is lower than the national average. Additionally, the
results indicate that these areas score below the 80th percentile (in
comparison to the nation as a whole) in the twelve EJ Indexes
established by EPA, which include a combination of environmental and
demographic information. EPA has provided that if any of the EJ indexes
for the areas under consideration are at or above the 80th percentile
nationally, then further review may be appropriate. Based on the
information presented, at a minimum, this action would not worsen any
existing air quality and is expected to ensure the area is meeting
requirements to attain and/or maintain air quality standards. Further,
there is no information in the record indicating that this action is
expected to have disproportionately high or adverse human health or
environmental effects on a particular group of people.
    Indiana Harbor East and Indiana Harbor West are owned and operated
by the same parent company, and the facilities share the same
ArcelorMittal USA LLC administrative address. According to the census
data available through EJSCREEN, comparing both facilities, the
administrative address is closest in proximity to a higher total
population center. EPA identified environmental burdens and susceptible
populations in communities nearby, by performing a screening-level
analysis using the EPA's EJSCREEN tool. EPA utilized the EJSCREEN tool
to evaluate environmental and demographic indicators of the communities
within a 1-mile radius of the ArcelorMittal USA LLC facilities'
administrative address in Lake County. For the 1-mile buffer, EPA
reviewed the EJSCREEN tool for the demographic indicators at the
ArcelorMittal USA LLC facilities, specifically for the ``Demographic
Index'', which is the average of an area's percent people of color and
percent low-income populations. EPA then compared the data to the
national Demographic Index average. The results of this analysis are
being provided for informational and transparency purposes. The results
of the demographic analysis indicate that, the Demographic Index at the
ArcelorMittal USA LLC location is higher than the national average.
Additionally, the results indicate that the area scores above the 80th
percentile (in comparison to the nation as whole) in all twelve EJ
Indexes established by EPA, which include a combination of
environmental and demographic information. At a state-level comparison
in the 1-mile buffer to the ArcelorMittal USA LLC facilities, all EJ
Indexes scored above the 80th percentile with one exception, the EJ
Index for Ozone scored at a 76th percentile. This EJ Index considers
the ozone summer seasonal average of daily maximum 8-hour concentration
in the air.
    EPA has provided that if any of the EJ indexes for the areas under
consideration are at or above the 80th percentile nationally, then
further review may be appropriate. As discussed in the EPA's EJ
technical guidance, people of color and low-income populations often
experience greater exposure and disease burdens than the general
population, which can increase their susceptibility to adverse health
effects from environmental stressors. Underserved communities can also
experience reduced access to health care, nutritional, and fitness
resources, further increasing their susceptibility.
    Considering these results, we expect that this action and resulting
emissions reductions will be neutral or contribute to reduced
environmental and health impacts on all populations in Lake County,
Indiana, including people of color and low-income populations. This
proposed rule, if finalized, will further improve local air quality by
reducing SO2 emissions in Lake County that was designated
attainment/unclassifiable during Round 3 designations for the 2010
SO2 standard (83 FR 1098, January 9, 2018). Based on the
information presented, at a minimum, this action would not worsen any
existing air quality and is expected to ensure the area is meeting
requirements to attain and/or maintain the SO2 air quality
standard.
    Further, in this action, EPA is proposing to approve the revisions
to SO2 emission limits and removal of emission units at the
NIPSCO, ArcelorMittal USA LLC (Indiana Harbor West) and ArcelorMittal
USA LLC (Indiana Harbor East) facilities into the Indiana SIP. Thus,
EPA believes that finalizing this action will help to reduce potential
disproportionate health, environmental, economic, and climate impacts
on disadvantaged communities in the area surrounding the ArcelorMittal
USA LLC facilities and that this action will not have
disproportionately high and adverse human health or environmental
effects on minority populations, low-income populations and/or
indigenous peoples.

V. What action is EPA proposing?

    EPA proposes approval of the March 31, 2021, SIP revision request
for Indiana's SO2 rules for NIPSCO (326 IAC 7-4-14(2)),
ArcelorMittal USA LLC (Indiana Harbor West) (326 IAC 7-4.1-10), and
ArcelorMittal USA LLC (Indiana Harbor East) (326 IAC 7-4.1-11). This
will strengthen the Indiana SO2 SIP by lowering
SO2 emission limits overall and update monitoring compliance
requirements to the Indiana Harbor East facility.

VI. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Indiana rules 326 IAC 7-4-14(2), 326 IAC 7-4.1-10, and 326
IAC 7-4.1-11, effective March 31, 2021, discussed in section II. of
this preamble. EPA has made, and will continue to make, these documents
generally available through www.regulations.gov and at the EPA Region 5
Office (please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section of this preamble for more information).

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 14094 (88 FR 21879, April 11, 2023);
     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 subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     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 Clean Air Act.
    In addition, 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 and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    Executive Order 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    IDEM did not evaluate environmental justice considerations as part
of its SIP submittal; the CAA and applicable implementing regulations
neither prohibit nor require such an evaluation. EPA performed an
environmental justice analysis, as is described in section IV of this
preamble titled, ``Environmental Justice Considerations.'' The analysis
was done for the purpose of providing additional context and
information about this rulemaking to the public, not as a basis of the
action. Due to the nature of the action being taken here, this action
is expected to have a neutral to positive impact on the air quality of
the affected area. In addition, there is no information in the record
upon which this decision is based inconsistent with the stated goal of
E.O. 12898 of achieving environmental justice for minority, low-income
populations, and Indigenous peoples.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: June 20, 2023.
Debra Shore,
Regional Administrator, Region 5.
[FR Doc. 2023-13524 Filed 6-23-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48558-48559]
[DOCID:fr23se09-66]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0625; FRL-8437-9]

Receipt of Application; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is making available for comment a registration application
submitted by Scimetrics Ltd. Corp. requesting the addition of the
black-tailed prairie dog and their host fleas for the chemical
combination of the anticoagulant rodenticide, diphacinone and the
insecticide, imidacloprid. Diphacinone and imidacloprid are chemicals
currently registered with the Agency. In consideration of recent public
interest in pesticide products intended to control the black-tailed
prairie dog, EPA is providing public notice of its receipt of this
application and an opportunity for the public to comment on the
application.

DATES: Comments must be received on or before October 23, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0625, by one of the following methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0625. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 regulations.gov or e-
mail. The regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to various environmental groups, farmers,
ranchers, state regulatory partners, other interested federal agencies,
members of the public interested in the sale, distribution, or use of
pesticides, and other pesticide registrants and pesticide users. Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
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:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

    EPA is making available for comment a registration application for
a product containing the chemical combination of the anticoagulant
rodenticide, diphacinone and the insecticide, imidacloprid, to control
black-tailed prairie dogs and their host fleas. EPA is providing this
comment opportunity because it believes that pesticide products
intended to control black-tailed prairie dogs have been the subject of
particular public interest in recent years. Diphacinone is currently
registered for use against rodents, including Norway rats, roof rats,
house mice, ground squirrels, and voles. Imidacloprid is currently
registered as an insecticide to control host fleas on the California
ground squirrel. EPA will evaluate all comments received during the
public comment period. The application would, if accepted by EPA, allow
the use of diphacinone and imidacloprid for the control of the black-
tailed prairie dogs and their host fleas.
    A copy of the application (with information claimed by the
applicant as CBI redacted) is available for public review in the docket
established for this new use application as described under ADDRESSES.
    Following the review of the application, and any comments and data
received in response to this solicitation, EPA will decide whether to
issue or deny the registration application, and if issued, the
conditions under which it is to be granted.

List of Subjects

    Environmental protection, Receipt of application.

    Dated: September 14, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E9-22810 Filed 9-22-09; 8:45 am]

BILLING CODE 6560-50-S


section 13(a) or 15(d) of the Exchange Act or both.
    B. Identify the means, such as publication in a particular
newspaper, used to disseminate the notice in the United States.

Instruction to Item 7

    If you have submitted a copy of the notice under cover of a Form
6-K (17 CFR 249.306), disclose the submission date of the Form 6-K.
If not, attach a copy of the notice as an exhibit to this Form. See
Rule 12h-6(g).

Item 8. Prior Form 15 Filers

    If relying on Rule 12h-6(h):
    A. Disclose whether, before the effective date of Rule 12h-6,
you filed a Form 15 (17 CFR 249.323) to terminate the registration
of a class of equity securities pursuant to Rule 12g-4 (17 CFR
240.12g-4) or to suspend your reporting obligations under section
15(d) of the Act regarding a class of equity or debt securities
pursuant to Rule 12h-3 (17 CFR 240.12h-3). If so, disclose the date
that you filed the Form 15. If you suspended your reporting
obligations by the terms of section 15(d), disclose the effective
date of that suspension as well as the date that you filed a Form 15
to notify the Commission of that suspension pursuant to Rule 15d-6
(17 CFR 240.15d-6).
    B. Disclose whether, since the effectiveness of your termination
of registration pursuant to Rule 12g-4, or of your suspension of
reporting pursuant to Rule 12h-3 or section 15(d) of the Exchange
Act, your reporting obligations under section 13(a) or section 15(d)
of the Exchange Act have remained terminated or suspended.
    C. If you terminated the registration of a class of equity
securities pursuant to Rule 12g-4 or suspended your reporting
obligations regarding a class of equity securities pursuant to Rule
12h-3 or section 15(d) of the Exchange Act, provide the disclosure
required by Item 3 of this Form, ``Primary Trading Market.''

Part II

Item 9. Rule 12g3-2(b) Exemption

    Disclose the address of your Internet Web site or of the
electronic information delivery system in your primary trading
market on which you will publish the information required under Rule
12g3-2(b)(1)(iii) (17 CFR 240.12g3-2(b)(1)(iii)).

Instruction to Item 9

    Refer to Note 1 to Rule 12g3-2(e) for instructions regarding
providing English translations of documents published pursuant to
Rule 12g3-2(b)(1)(iii) (17 CFR 240.12g3-2(b)(1)(iii).

Part III

Item 10. Exhibits

    List the exhibits attached to this Form.

Instruction to Item 10

    In addition to exhibits specifically mentioned on this Form, you
may attach as an exhibit any document providing information that is
material to your eligibility to terminate your reporting obligations
under Exchange Act Rule 12h-6. You should refer to any relevant
exhibit when responding to the items on this Form.

Item 11. Undertakings

    Furnish the following undertaking:
    The undersigned issuer hereby undertakes to withdraw this Form
15F if, at any time before the effectiveness of its termination of
reporting under Rule 12h-6, it has actual knowledge of information
that causes it reasonably to believe that, at the time of filing the
Form 15F:
    (1) The average daily trading volume of its subject class of
securities in the United States during a recent 12-month period
exceeded 5 percent of the average daily trading volume of that class
of securities in the issuer's primary trading market during the same
period, if proceeding under Rule 12h-6(a)(4)(i);
    (2) Its subject class of securities was held of record by 300 or
more United States residents or 300 or more persons worldwide, if
proceeding under Rule 12h-6(a)(4)(ii) or Rule 12h-6(b); or
    (3) It otherwise no longer qualified for termination of its
Exchange Act reporting obligations under Rule 12h-6.

Instruction to Item 11

    After filing this Form, an issuer has no continuing obligation
to make inquiries or perform other work concerning the information
contained in this Form, including its assessment of trading volume
or ownership of its securities in the United States.

Signature

    Pursuant to the requirements of the Securities Exchange Act of
1934, [name of registrant as specified in charter] has duly
authorized the undersigned person to sign on its behalf this
certification on Form 15F. In so doing, [name of registrant as
specified in charter] certifies that, as represented on this Form,
it has complied with all of the conditions set forth in Rule 12h-6
for terminating its registration under section 12(g) of the Exchange
Act, or its duty to file reports under section 13(a) or section
15(d) of the Exchange Act, or both.
By:--------------------------------------------------------------------

Title:-----------------------------------------------------------------

Date:------------------------------------------------------------------

    By the Commission.

    Dated: December 22, 2006.
Florence E. Harmon,
Deputy Secretary.

[FR Doc. E6-22405 Filed 1-10-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17483-17484]
[DOCID:fr15ap09-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0044; FRL-8790-9]

Method and Format for Submitting Risk Management Plans (RMPs)
Under Section 112(r) of the Clean Air Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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

SUMMARY: This notice provides information on the method and format for
submitting risk management plans (RMPs) under EPA's Chemical Accident
Prevention regulations. These regulations require owners and operators
of stationary sources subject to the regulations to submit RMPs on
their processes in a method and format specified by EPA. A new RMP
submission method, called RMP*eSubmit, should be used by facilities
submitting their RMPs electronically beginning March 13, 2009. The new
submission method will be On-line via EPA's secure Web site.

FOR FURTHER INFORMATION CONTACT: Armando Santiago, Evaluation and
Communications Division, Office of Emergency Management (Mail Code
5104A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460 at<PHONE_NUMBER> or e-mail address:
<EMAIL_ADDRESS>or contact Peter Gattuso, Regulation and
Policy Development Division, Office of Emergency Management (Mail Code
5104A), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460 at<PHONE_NUMBER> or e-mail address:
<EMAIL_ADDRESS>
I. General Information

A. What Are the Affected or Regulated Entities?

    Entities affected by this action are those stationary sources that
are subject to the chemical accident prevention requirements in 40 CFR
part 68. Affected categories and entities include, but are not limited
to, chemical manufacturers, refineries, other manufacturers,
agricultural retailers, public sources, utilities, cold storage
facilities, warehouses, wholesalers, and Federal sources.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2003-0044. Publicly available docket materials
are available either electronically through http://www.regulations.gov
or in hard copy at the Air Docket in the EPA Docket Center, EPA West,
Room 3334, 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
reading room is<PHONE_NUMBER>, and the telephone number for the Air
Docket is<PHONE_NUMBER>.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

SUPPLEMENTARY INFORMATION: The chemical accident prevention regulations
in 40 CFR part 68 require stationary sources to submit their RMPs to a
central location in a method and format specified by EPA. EPA has now
developed a new system for facilities to submit their RMPs. The new
system, called RMP*eSubmit, is an on-line submission system. EPA's
existing system for accepting RMPs on diskette, called RMP*Submit, has
been in place since early 1999 for the first submission deadline, June
21, 1999, and will be discontinued. Those facilities that are unable to
submit RMPs using the on-line submission system may still submit their
RMPs in paper form.
    Beginning March 13, 2009, EPA will ask facilities to submit their
RMPs Online via EPA's secure Web site, https://cdx.epa.gov. This secure
portal manages thousands of data submissions from States and industry.
For sources that have submitted an RMP previously, EPA will mail them a
letter with directions on how to submit their RMPs Online. For sources
that are submitting an RMP for the first time, EPA will provide
instructions for using the Online system via the Agency's public Web
site at http://www.epa.gov/emergencies/rmp. EPA has also developed a
user's manual to provide additional information on using the new
reporting system. The user's manual will also be available at the above
public Web site.
    EPA is not requiring any new data elements with this new reporting
system. The current requirements are approved by the Office of
Management and Budget (OMB) under the paperwork

reduction act (PRA). The current Information Collection Request (ICR)
required under the PRA and approved by OMB is available at
www.regulations.gov, EPA docket number, EPA-HQ-OAR-2003-0052.

    Dated: March 30, 2009.
Deborah Y. Dietrich,
Director, Office of Emergency Management.
[FR Doc. E9-8653 Filed 4-14-09; 8:45 am]

BILLING CODE 6560-50-P


39547 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices F. International Tolerances To date, no international tolerances exist for indoxacarb. [ FR Doc. 03   16739 Filed 7   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0211; FRL   7312   8]

Dinotefuran; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0211, must be received on or before August 1, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8291; e mail address: kumar. rita@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

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

B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0211. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in EPA's Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39548 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0211. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0211. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0211. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2003   0211. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as 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. 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. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 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.

II. What Action is the Agency Taking?

EPA has received pesticide petitions as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions.

List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: June 20, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

Summary of Petition The petitioner's summary of the pesticide petitions is printed below as required by FFDCA section 408( d)( 3). The summary of the petitions was prepared by the petitioner and represents the view of the petitioner. The petitions summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

Mitsui Chemicals, Inc.

PP 2F6427 and 3F6566 EPA has received pesticide petitions ( 2F6427 and 3F6566) from Mitsui Chemicals, Inc., Chiyoda ku, Tokyo, Japan, proposing pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing tolerances for residues of dinotefuran, ( RS) 1 methyl 2 nitro 3 ( tetrahydro 3 furylmethyl) guanidine and its major metabolites, 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine,

VerDate Jan< 31> 2003 21: 04 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39549 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices and 1 methyl 3( tetrahydro 3 furylmethyl) urea, in or on fruiting vegetables, leafy vegetables, head and stem brassica vegetables, cotton, cucurbits, grapes, and potato. The tolerances are set at the following value: Fruiting vegetables, 0.7 part per million ( ppm); leafy vegetables, 5.0 ppm; tomato paste, 1.0 ppm; cucurbits, 0.5 ppm; head and stem brassica vegetables, 1.4 ppm; grape, 0.8 ppm; raisin, 2.5 ppm; potato, 0.05 ppm; chips, 0.10 ppm; granules, 0.15 ppm; cotton seed undelinted at 0.2 ppm, and cotton gin byproducts at 7.0 ppm. Tolerances for meat, milk, and byproducts is set at 0.05 ppm. This new active ingredient has been accepted by EPA as a reduced risk chemical. EPA has determined that the petitions contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petitions. Additional data may be needed before EPA rules on the petitions.

A. Residue Chemistry 1. Plant metabolism. The primary metabolic pathways of dinotefuran in plants ( rice, apple, potato, oilseed, rape, and lettuce) were similar to those described for animals, with certain extensions of the pathway in plants. Parent compound, dinotefuran, and two metabolites, 1 methyl 3( tetrahydro 3 furymethyl) guanidine and 1 methyl 3 ( tetrahydro 3 furymethyl) urea were major metabolites in all crops. The metabolism of dinotefuran in plants and animals is understood for the purposes of the proposed tolerances. Parent dinotefuran and the metabolites, 1 methyl 3( tetrahydro 3 furymethyl) guanidine and 1 methyl 3 ( tetrahydro 3 furymethyl) urea are the residues of concern for tolerance setting purposes. 2. Analytical method. Mitsui Chemicals, Inc., has submitted practical analytical methodology for detecting and measuring levels of dinotefuran and its metabolites, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine and 1 methyl 3( tetrahydro 3 furylmethyl) urea, in or on raw agricultural commodities ( RACs). The high performance liquid chromotography ( HPLC) method was validated for determination of, dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea in or on tomatoes, peppers, cucurbits, brassica, grapes, potatoes, and lettuce for raw agricultural commodity matrices and in or on tomato paste, puree, grape juice, raisins, potato chips, granules, and wet peel for processed commodity matrices. After extraction with a water/ acetonitrile mixture and clean up with hexane and extraction columns, concentrations of dinotefuran and its metabolites were quantified after HPLC separation by mass spectrometry/ molecular size ( MS/ MS) detection. The limit of quantitation ( LOQ) was 0.01 ppm for all matrices. The HPLC method was validated for the determination of dinotefuran and 1 methyl 3( tetrahydro 3 furylmethyl) urea in or on cotton ( undelinted seed, gin trash, meal, hulls, refined oil), and leafy vegetables. After extraction with a water/ acetonitrile mixture and clean up dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea were quantified after HPLC separation by MS/ MS detection. For undelinted seed, gin trash, meal, and hulls, a LOQ of 0.05 milligram/ kilogram ( mg/ kg) and a working range from 0.05 to 0.50 mg/ kg were successfully validated for dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea. For refined oil, a LOQ of 0.01 mg/ kg and a working range from 0.01 to 0.10 mg/ kg were successfully validated for dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea. An HPLC method was validated for the determination of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea, in lettuce. After extraction with water/ acetonitrile mixture and clean up, dinotefuran was quantified after HPLC separation by ultraviolet ray ( UV) detection, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea by MSD. A LOQ 0.010 mg/ kg and a working range from 0.01 to 5.00 mg/ kg were successfully validated from dinotefuran, 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea. All of the above methods have been independently validated. 3. Magnitude of residues. Crops in residue trials were treated at maximum label rates and harvested at the specified minimum treatment to harvest intervals. The residue method for dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, in all components utilized HPLC separation with MS/ MS detection. For cucurbit vegetables ( crop group 9), residue trials were conducted for each of the three representative crops, cucumbers, melons, and squash. The proposed tolerance in or on cucurbit vegetables for combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, is 0.5 ppm. The maximum combined residue found for the representative cucurbit vegetable crops was 0.44 ppm for a melon sample. For leafy vegetables ( crop group 4), residue trials were conducted for each of the four representative crops, celery, leaf lettuce, head lettuce, and spinach, at six locations. The proposed tolerance in or on leafy vegetables for combined residues of dinotefuran, 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea, is 5.0 ppm. The maximum combined residue found for the representative leafy vegetable crops was 4.36 ppm for a spinach sample. Residue trials for cotton were conducted at 13 locations and undelinted cotton seed samples were collected and analyzed. Cotton gin byproducts ( gin trash) samples were obtained for 7 of the locations. Processing studies with analyses of cotton seed meal, hulls, and oil were performed with cotton seed harvested at two locations that were both treated with 5X the maximum label rate. The proposed tolerance for combined residues of dinotefuran, 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea, in or on cotton seed undelinted is 0.2 ppm. All cotton seed residue samples had combined residues of less than 0.2 ppm. The proposed tolerance for cotton gin byproducts is 7.0 ppm for combined residues of dinotefuran and its two major metabolites. The maximum combined residues for cotton gin byproducts in these trials was 6.4 ppm. Processing studies established that residues of dinotefuran and its metabolites, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, did not concentrate in cotton seed meal, oil, or hulls. Therefore, tolerances are not proposed for these processing fractions. Residue trials for grapes were conducted at 13 locations and 2 grape juice and raisin processing studies were performed with grapes from exaggerated treatment rate applications. The proposed tolerance for combined residues of dinotefuran, 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea, in or on grapes is 0.8 ppm. The maximum combined residue for an individual grape residue sample was 0.73 ppm and the highest average field trial ( HAFT) for grapes had VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39550 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices combined residues of 0.55 ppm. The proposed tolerance for raisins is 2.5 ppm for combined residues of dinotefuran and its two major metabolites based on the average concentration factor of 4.0 for processing grapes to raisins. The grape juice processing studies established an average concentration factor of 1.3 for residues of dinotefuran and its metabolites 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, because the product of multiplying the grape HAFT times the average concentration factor for processing grapes into juice is less than the proposed grape tolerance, a separate tolerance is not proposed for grape juice. For potatoes, residue trials were performed at 17 locations and 2 studies processing potatoes into chips, granules, and wet peel were performed with potatoes that were treated with exaggerated application rates. The proposed tolerance for combined residues of dinotefuran and its metabolites 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, on potatoes is 0.05 ppm. The maximum combined residues found on potatoes were less than 0.05 ppm with maximum residues of dinotefuran less than 0.03 ppm. The HAFT result was 0.04 ppm of combined residues. The average concentration factors for processing potatoes into chips, granules, and wet peel were 2.2, 3.65, and less than 1 respectively. No separate tolerance is proposed for wet peel. Based on the average concentration factors and the HAFT, tolerances for combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3( tetrahydro 3 furylmethyl) urea, are proposed for potato chips at 0.1 ppm and for potato granules at 0.15 ppm. For fruiting vegetables ( crop group 8) residue trials were conducted for the three representative commodities, tomatoes, bell pepper, and non bell pepper. The proposed tolerance for combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, in or on fruiting vegetables is 0.7 ppm. The maximum combined residue for the representative fruiting vegetables was 0.58 ppm on peppers. The HAFT result for combined residues on tomatoes was 0.20 ppm. Three studies for processing tomatoes into tomato puree and tomato paste were performed with tomatoes that were treated at exaggerated application rates. The average concentration factors determined in these studies were 1.8 for processing tomatoes into puree and 4.8 for processing tomatoes into paste. Since the product of the average concentration factor for puree and the HAFT for tomatoes is less than the proposed tolerance for fruiting vegetables, no separate tolerance is proposed for tomato puree. A combined tolerance of 1.0 ppm is proposed for tomato paste, based on the average concentration factor for processing of 4.8 and the HAFT of 0.20 ppm for tomatoes. For vegetables, brassica head, and stem crop subgroup ( crop subgroup 5   A), residue trials were conducted with three representative crops, broccoli, cauliflower, and cabbage. The proposed tolerance for combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, on stem and head brassica vegetables is 1.4 ppm. The maximum combined residue in field trials was 1.25 ppm on broccoli. Metabolism studies in livestock and poultry ( nature of residue studies with goats and hens), established that dinotefuran was rapidly metabolized and excreted and that there was very little transmittal of residues of dinotefuran and its metabolites to meat, milk, or eggs. For goats fed 10 ppm of radiolabeled dinotefuran, the total radioactive residues ( TRR) in meat and milk were less than 0.05 ppm. The maximum livestock dietary burden from feeding cotton commodities and potatoes ( which all contain residues at the proposed tolerance levels) was 1.9 ppm for beef cattle and 1.9 ppm for dairy cattle. To provide for the possible transmittal of the residues of dinotefuran and its metabolites, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, in cattle and other livestock, tolerances are proposed for combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, in milk at 0.05 ppm, in meat ( from cattle, goats, hogs, horses, and sheep) at 0.05 ppm and in meat byproducts, including fat, liver, and kidney, ( from cattle, goats, hogs, horses, and sheep) at 0.05 ppm. These proposed tolerances are based on the results of a cow feeding study where dairy cows received dosages of combined residues of dinotefuran and its metabolites and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, representing 5ppm ( 1X), 15 ppm ( 3X), and 50 ppm ( 10X) in the daily diet. The dosages contained dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, in a 3: 1: 1 ratio, thus, the 5 ppm level contained 3 ppm of dinotefuran, 1 ppm of 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 ppm of 1 methyl 3( tetrahydro 3 furylmethyl) urea. The dosing period was 29 to 30 days, whole milk, skim milk, and cream were analyzed through the collection period and meat, fat, and edible tissues were analyzed at conclusion of the dosing period. There were only low levels of residues transmitted to milk, meat, fat, and edible tissues in the study. No dinotefuran residues (< 0.01 ppm) were measured in milk from 5 ppm dosage cows. Maximum residues of dinotefuran in milk were 0.012 ppm in the 3X level cows and 0.032 ppm in the 10X level cows. No detectable residues of parent dinotefuran were found in muscle, fat, or edible tissues from cows at any dosage level. Milk, muscle, fat, and edible tissues were also analyzed for 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea, the two dinotefuran metabolites included in the combined residues in the proposed tolerance expression. Transmittal of quantifiable residues of 1 methyl 3 ( tetrahydro 3 furylmethyl) guanidine was found at the 1X dosage level with maximum residues of 0.013 ppm of 1 methyl 3( tetrahydro 3 furylmethyl) guanidine in milk and at the 10X level with 0.011 ppm of 1 methyl 3( tetrahydro 3 furylmethyl) guanidine in milk and 0.02 ppm of 1 methyl 3( tetrahydro 3 furylmethyl) guanidine in muscle, liver, and kidney. Quantifiable residues of 1 methyl 3( tetrahydro 3 furylmethyl) urea were found in the 1X dosage level, with 1 methyl 3( tetrahydro 3 furylmethyl) urea residues up to 0.02 ppm in whole milk and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea residues of 0.011 to 0.012 in muscle, liver, and kidney. The 1 methyl 3( tetrahydro 3 furylmethyl) urea residues increased proportional to dosage with the 10X level having 1 methyl 3( tetrahydro 3 furylmethyl) urea residues of up to 0.24 ppm in milk, 0.13 ppm in muscle, 0.07 ppm in fat, 0.12 ppm in liver, and 0.18 ppm in kidney. In the cow feeding study at the 1X dosage level comprising combined residues of dinotefuran, 1 methyl 3( tetrahydro 3 furylmethyl) guanidine, and 1 methyl 3 ( tetrahydro 3 furylmethyl) urea of 5 ppm of diet, the total combined residues for milk, muscle, fat, liver, and kidney were each less than 0.05 ppm. Since the maximum theoretical combined VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39551 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices residues from the proposed uses of dinotefuran on cotton and potatoes would be 1.9 ppm, for dairy and beef cattle, the proposed tolerances in milk, meat, and meat byproducts, would be sufficient to provide for potential transmittal of residues from livestock diets containing residues of dinotefuran and its metabolites. The maximum theoretical poultry dietary burden from feeding cotton commodities containing residues of dinotefuran and its metabolites at the proposed tolerance levels was calculated to be 0.09 ppm. Since the TRR in meat and eggs from hens fed 10 ppm of radiolabeled dinotefuran in the poultry metabolism study was less than 0.05 ppm it can be concluded that there is no reasonable expectation of transmittal of finite residues of dinotefuran and its metabolites to meat and eggs, for poultry fed cotton commodities treated with dinotefuran. Therefore no tolerances are proposed for combined residues of dinotefuran and its metabolites in poultry or eggs.

B. Toxicological Profile 1. Acute toxicity. Dinotefuran has low acute oral, dermal, and inhalation toxicity. The oral lethal dose ( LD) 50 in rats is 2,450 mg/ kg, the dermal LD50 is > 2,000 mg/ kg and the inhalation 4 hour lethal concentration ( LC) 50 is > 4.09 milligrams/ Liter ( mg/ L) air. Dinotefuran is not a skin sensitizer in guinea pigs, but is slightly irritating to the skin and eyes of rabbits. End use formulations of dinotefuran have similar low acute toxicity profiles. 2. Genotoxicity. Dinotefuran and its metabolites do not induce gene mutations in bacterial and mammalian cells, chromosome aberrations in mammalian cells or deoxyribonucleic acid ( DNA) damage in bacterial cells in in vitro test systems. Similarly, it does not exhibit a clastogenic effect in vivo in the mouse micronucleus test. Therefore, there is no evidence to suggest a genotoxic hazard at any of the three main levels of genetic organization. 3. Reproductive and developmental toxicity. In rat and rabbit developmental toxicity studies with dinotefuran, there was no evidence of teratogenicity or other embryotoxic effects at the highest dose levels, although maternal toxicity was evident. There were no treatmentrelated effects on litter parameters at any dose level in either species. In rats, 1,000 mg/ kg produced decreased food consumption, body weight gain, and increased water intake. In rabbits, 300 mg/ kg produced hypoactivity, prone position, panting, flushing of the nose and ears, tremors, reduced weight gain, food consumption, and water intake. Necropsy revealed pale brown discoloration of liver and gray/ white plaques in the stomach at 125 and 300 mg/ kg. The no adverse effect level ( NOAEL) values in maternal rats and rabbits were 300 and 52 mg/ kg/ day, respectively. The NOAEL values in rats and rabbits for embryonic development and teratogenicity were the highest dose levels administered, 1,000 and 300 mg/ kg/ day, respectively. In a 2 generation study, parental animals of both sexes and both generations showed reduced body weight gain and food consumption at the highest dose level evaluated ( 10,000 ppm), but there was no effect of treatment at any dose level in either generation on reproductive performance indicators. There were no treatmentrelated effects at any dose level on the histopathological appearance of the reproductive organs of either sex. Similarly, there were no effects at any dose level in either generation on quantitative ovarian histopathology or on sperm counts, motility and morphology. Reduced spleen weight in probit dose extrapolation model ( P) generation animals and reduced thyroid weight in F1 generation parental females were apparent at 10,000 ppm. F1 pup behavioral and sexual development was unaffected by treatment at all dose levels but pup weight gain during lactation was reduced at 10,000 ppm in both generations. Furthermore, the spleen weight of F1 generation progeny was reduced at 10,000 ppm. Based on reduced weight gain and food consumption in parental animals at 10,000 ppm and reduced pre weaning weight gain in the offspring, the NOAEL value for parental animals and offspring is 241 mg/ kg. 4. Subchronic toxicity. Dinotefuran was evaluated in a 13 week oral ( diet) toxicity studies in rats, mice, and dogs. No specific target organs were identified in any species. In the rat study, a NOAEL of 500 ppm ( 34/ 38 mg/ kg/ day for males and females) was established, based on minimal growth retardation in females and adrenal cortical vacuolation in males. A NOAEL was established at 5,000 ppm ( 336/ 384 mg/ kg/ day for males/ females) based on marked growth retardation at 25,000 ppm ( adrenal cortical vacuolation not adverse). In the mouse study, a NOAEL of 25,000 ppm ( 4,442/ 5,414 mg/ kg/ day for males/ females) was established based on growth retardation at 50,000 ppm. In the dog study, a NOAEL of 8,000 ppm ( 307/ 323 mg/ kg/ day in males/ females) was established based on growth retardation. Dinotefuran was also evaluated for dermal and inhalation toxicity for 4 weeks in rats. Daily inhalation exposure of rats for 6 hours/ day for 4 weeks did not elicit toxicologically significant effects at any exposure concentration up to and including the highest technically achievable concentration ( 2.08 mg/ L) with a low mass median aerodynamic diameter) ( MMAD  ± GSM of 2.03 µ m ± 3.60. Dinotefuran was well tolerated and there were no treatment related effects on clinical condition, hematology, and clinical chemistry profiles, organ weights, macroscopic, and microscopic pathology. Dermal application for 4 weeks at dose levels up to 1,000 mg/ kg/ day did not elicit any local or systemic effects on any of the parameters examined. Therefore, no target organs were identified in the rat either by dermal or inhalation exposure. 5. Neurotoxicity. Dinotefuran did not produce any functional or histomorphological evidence of neurotoxicity in acute ( gavage) and 13   week ( dietary) neurotoxicity studies in rats. The NOAEL for neurotoxicity in the acute study was 1,500 mg/ kg, the highest dose level administered. The NOAEL for neurotoxicity in the 13   week dietary study was 50,000 ppm ( 3,413/ 3,806 mg/ kg/ day for males and females). The NOAEL for all effects in this study was 5,000 ppm ( 327/ 400 mg/ kg/ day for males and females) based on reduced body weight gain and food consumption. 6. Chronic toxicity. Chronic toxicity studies with dinotefuran have been conducted in rats, mice, and dogs. In common with the subchronic studies in these species, no specific target organs could be identified. In the 52 week dog study, a NOAEL of 559/ 512 mg/ kg/ day for males/ females was established based on decreased weight gain in both sexes and decreased food consumption in females. In the 78 week mouse study, a NOAEL of 345/ 441 mg/ kg/ day for males/ females was established, based on decreased weight gain and a decrease in circulating platelet counts. In the 104 week rat study, a NOAEL of 991/ 127 mg/ kg/ day for males/ females was established. This was based on a decrease in weight gain in females. 7. Carcinogenicity. The carcinogenic potential of dinotefuran has been evaluated in rats and mice. Survival incidences in the oncogenicity studies were unaffected by treatment at all dose levels. There were no treatment related effects on the nature and incidence of neoplastic and adverse non neoplastic histomorphological findings in either species at any dose level. Therefore, the NOAEL values for all effects, 991/ 127 mg/ kg/ day ( male/ female rats) and 345/ 441 mg/ kg/ day ( male/ female mice) are based on reduced weight gain, and also VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39552 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices on reduced numbers of platelets in mice. 8. Animal metabolism. In the rat, dinotefuran is rapidly and almost completely absorbed from the gastrointestinal tract into the general circulation, and is widely distributed throughout the tissues and fluids of the body. Elimination is rapid, predominantly by urinary excretion and almost complete within 7 days of administration. There is no evidence for tissue accumulation. Dinotefuran is rapidly transferred to maternal milk and widely distributed into fetal tissues but rapidly eliminated from them. More than 90% of orally and intravenously administered dinotefuran is eliminated as unchanged parent molecule, which is also the major radioactive component in plasma, milk, bile, and most tissues. The major route of metabolism is an initial enzymatic hydroxylation of the tetrahydrofuran ring to form isomers of 6 hydroxy 5( 2 hydroxyethyl) 1 methyl 1,3 diazinane 2 ylidine N nitroamine, followed by further oxidation, reduction and acetylation of 6 hydroxy 5( 2 hydroxyethyl) 1 methyl 1,3 diazinane 2 ylidine N nitroamine, to produce possible isomers of 1 methyl 2 nitro 3 ( 2 oxotetrahydro 3 furylmethyl) guanidine, 1[ 4 hydroxy 2 ( hydroxymethyl) butyl] 3 methyl 2 nitroguanidine, 6 hydroxy 5( 2 hydroxyethyl) 1 methyl 1, 3 diazinane 2 ylidene N nitroamine acetyl conjugate and 3 hydroxymethyl 4 ( 3 methyl 2 nitroguanidine) butyric acid. Several minor pathways of metabolism of dinotefuran were identified in animals. The absorption, distribution, metabolism and elimination of dinotefuran is unaffected by sex and treatment regimen. In hens and goats, the metabolite profile was similar as in plant metabolism. 9. Metabolite toxicology. The metabolism profile for dinotefuran supports the use of an analytical enforcement method that accounts for parent dinotefuran, and 1 methyl 3 ( tetrahydro 3 furymethyl) guanidine and 1 methyl 3( tetrahydro 3 furymethyl) urea. Other metabolites are considered of equal or lesser toxicity than parent compound. 10. Endocrine disruption. Dinotefuran does not belong to a class of chemicals known or suspected of having adverse effects on the endocrine system. There is no evidence that dinotefuran has any effect on endocrine function in developmental or reproduction studies. Furthermore, histological investigation of endocrine organs in chronic dog, rat, and mouse studies did not indicate that the endocrine system is targeted by dinotefuran. C. Aggregate Exposure 1. Dietary exposure. Chronic dietary exposure assessments were conducted using a Tier I approach. This Tier I assessment incorporated tolerance level residues and 100% crop treated in the EXP estimated dietary intake trends evaluation system ( EXPediteTM system, Version 4.1). EXPediteTM utilized the food consumption data derived from the 1994   1996 U. S. Department of Agriculture ( USDA) Continuing Surveys of Food Intake by Individuals ( CSFII) with the 1998 supplemental children's survey. The resulting exposures were compared to a RfD of 1.27 mg/ kg/ day, which was based on the female NOAEL of 127 mg/ kg/ day from the 104 week rat study and a 100   fold uncertainty factor. Chronic dietary exposure estimates for the overall U. S. population and 25 population subgroups are well below the chronic RfD. Results of these analyses are summarized below.

TABLE 1.   CHRONIC DIETARY RISK ( DEEMTM) ANALYSIS OF DINOTEFURAN Population Subgroup Mg/ Kg Bwt/ Day % RfD U. S. population 0.004109 0.32%

All infants (< 1   year old) 0.002815 0.22%

Non nursing infants 0.003438 0.27%

Children ( 1 to 6) 0.007247 0.57%

Children ( 7 to 12) 0.004348 0.34%

Females ( 13 to 50) 0.003350 0.26%

Males 13+ years 0.003173 0.25%

There are no acute toxicity concerns with dinotefuran as there is no toxicological endpoint attributable to a single exposure in the dinotefuran toxicology data base, including the rat and rabbit developmental studies. Therefore, only chronic dietary exposures have been assessed. 2. Non dietary exposure. Mitsui also requests registrations for the use of dinotefuran on cats, turf, ornamentals, indoor foggers, and ready to use sprays. Mitsui has considered potential nondietary and aggregate ( non dietary + dietary) exposures to adults, adult females, and toddlers ( 1 to 3 years of age) for these uses. Applicator and post application exposures can result from dermal and inhalation routes for both adults and toddlers. Additionally, toddlers can be exposed through the post application incidental ingestion route via hand tomouth behavior. Based on the label instructions and typical use patterns of these product types, only short term and intermediate term exposure scenarios should be considered for dinotefuran products. However, since there are no toxicological endpoints attributable to a single or possible multiple exposures in a very short duration, as in a short term scenario, only the intermediate term exposure scenario has been evaluated for this document. Dermal exposures for applicator and post application activities were not assessed because the very high dermal NOAEL (> 1,000 mg/ kg/ day) for dinotefuran indicates that dermal exposures are not of concern. Short term oral ( e. g., incidental ingestion) exposures for toddlers, as mentioned above, were not assessed because there are no toxicological endpoints attributable to a single exposure or multiple exposures during a very shortterm time frame in the dinotefuran toxicology data base. Since the oral endpoint is used to calculate inhalation risks, short term inhalation exposures for toddlers and adults were also not evaluated since there is no toxicological endpoint attributable to a short term endpoint. Intermediate term inhalation exposures for applicator and postapplication activities also were not assessed because the very high inhalation NOAEL (> 7,000 mg/ kg/ day) for dinotefuran indicates that inhalation exposures are not of concern. Therefore, only intermediate term oral ( incidental ingestion) exposures for toddlers were assessed. These exposures were assessed for each individual dinotefuran product, as well as for the aggregation of all products. In the aggregate assessment, it was assumed that the toddlers would be exposed to residues resulting from the agricultural uses ( chronic dietary), all within 1 day. These non dietary assessments were conducted using equations and default parameters from EPA's Residential Standard Operation Procedures ( SOPs) ( EPA, 1997 and 2001) and maximum application rates. Although these exposures are based on the intermediate term time frame, the residue on the day of application was used in the SOP equations in order to maintain an extra level of conservatism. This assumption implies that the toddlers are exposed to residue levels, which are equivalent to levels resulting on the day of application, every day over an intermediate term time frame. The resulting oral and aggregate exposures were compared to the NOAEL VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39553 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices of 307 mg/ kg/ day observed in the 13 week dog study. These risk estimates ( margin of exposures ( MOE)) for toddlers ( 1 to 3 years of age) are summarized below. From the results below, Mitsui concludes there is reasonable certainty of no harm associated with the aggregate ( dietary + non dietary) exposure to dinotefuran.

TABLE 2.   INTERMEDIATE TERM AGGREGATE MOES Exposure Routes Dietary RTU Spray Fogger Turf Cat Aggregate Toddlers ( 1 to 3 years old)

Dietary 184,163 NA NA NA NA 184,163 Incidental Ingestion NA 23,356 11,431 80,050 1,850 1,410 Total 1,410 3. Drinking water exposure. EPA uses the drinking water level of comparison ( DWLOC) as a theoretical upper limit on a pesticide's concentration in drinking water when considering total aggregate exposure to a pesticide in food, drinking water, and residential uses. DWLOCs are not regulatory standards for drinking water; however, EPA uses DWLOCs in the risk assessment process as a surrogate measure of potential exposure from drinking water. In the absence of monitoring data for pesticides, it is used as a point of comparison against conservative model estimates of a pesticides concentration in water. An estimate of the drinking water environmental concentration ( DWEC) in ground water and surface water for dinotefuran has been made for this notice of filing. The DWEC of dinotefuran in ground water was estimated to be 0.94 part per billion ( ppb) using screening concentration in ground water ( SCI   GROW) ( the screening model for ground water), and the DWEC for surface water was estimated to be 6.24 ppb ( for chronic and intermediate term aggregate assessments) using FQPA Index Reservoir Screening Tool ( FIRST). To calculate the DWLOC for chronic aggregate exposure relative to a chronic toxicity endpoint, the chronic dietary food exposure from EXPediteTM, as addressed above, was subtracted from the reference dose ( RfD) to obtain the acceptable chronic exposure to dinotefuran in drinking water. DWLOCs, as presented below, were then calculated using default body weights and drinking water consumption figures.

TABLE 3.   CHRONIC AGGREGATE DRINKING WATER ASSESSMENT Population Subgroup Dietary Mg/ Kg Bwt/ Day Maximum Water Exposure Mg/ Kg Bwt/ Day Kg Bwt SCI   GROW ( ppb) FIRST ( ppb) DWLOC ( ppb)

U. S. population 0.004109 1.265891 70 0.94 6.24 44,306 All infants (< 1   year old) 0.002815 1.267185 10 0.94 6.24 12,672 Non nursing infants 0.003438 1.266562 10 0.94 6.24 12,666 Children ( 1 to 6) 0.007247 1.262753 20 0.94 6.24 25,255 Children ( 7 to 12) 0.004348 1.265652 40 0.94 6.24 50,626 Females ( 13 to 50) 0.003350 1.266650 60 0.94 6.24 38,000 Males ( 13+ years) 0.003173 1.266827 70 0.94 6.24 44,339 Chronic RfD used in assessments  1.27 mg/ kg bwt/ day The estimated average concentration of dinotefuran in surface water is 6.24 ppb. This value is less than the lowest DWLOC for dinotefuran as a contribution to chronic aggregate exposure ( 12,666 ppb for non nursing infants, the most highly exposed population group for the chronic scenario). Therefore, taking into account the proposed uses, it can be concluded with reasonable certainty that residues of dinotefuran in food and drinking water will not result in unacceptable levels of human health risk. To calculate the DWLOC for the intermediate term aggregate exposure relative to a sub chronic toxicity endpoint, the chronic dietary food exposure from EXPediteTM plus the intermediate term non dietary exposures were subtracted from the NOAEL, divided by the target MOE ( 100), to obtain the acceptable intermediate term exposure to dinotefuran in drinking water. DWLOCs, as presented below, were then calculated using default body weights and drinking water consumption figures.

VerDate Jan< 31> 2003 16: 33 Jul 01, 2003 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02JYN1. SGM 02JYN1 39554 Federal Register / Vol. 68, No. 127 / Wednesday, July 2, 2003 / Notices TABLE 4.   INTERMEDIATE TERM AGGREGATE DRINKING WATER ASSESSMENT Population Subgroup NOAEL/ MOE Mg/ Kg/ Day Aggregate Exposure Mg/ Kg/ Day Maximum Water Exposure mg/ kg/ day SCI   GROW ( ppb) FIRST ( ppb) DWLOC ( ppb)

Toddlers ( 1 to 3) 1 0.307 0.217 2.852 0.94 6.24 42,785 1 Assume 70kg bodyweight The estimated average concentration of dinotefuran in surface water is 6.24 ppb. This value is less than the DWLOC for dinotefuran as a contribution to intermediate term aggregate exposure ( 42,785 ppb). Therefore, taking into account the proposed uses, it can be concluded with reasonable certainty that residues of dinotefuran in residential environments and in food and drinking water will not result in unacceptable levels of human health risk.

D. Cumulative Effects The potential for cumulative effects of dinotefuran and other substances that have a common mechanism of toxicity has also been considered. Dinotefuran belongs to a pesticide chemical class known as the neonicotinoids and subclass nitroguanadines. There is no reliable information to indicate that toxic effects produced by dinotefuran would be cumulative with those of any other chemical including another pesticide. Therefore, Mitsui believes it is appropriate to consider only the potential risks of dinotefuran in an aggregate risk assessment.

E. Safety Determinations 1. U. S. population. Using the chronic exposure assumptions and the proposed RfD described above, the dietary exposure to dinotefuran for the U. S. population ( 48 states, all seasons) was calculated to be 0.32% of the RfD of 1.27 mg/ kg/ day. The resulting DWLOC, 44,306 ppb, is much greater than the estimated average concentration of dinotefuran in surface water, 6.24 ppb. Therefore, taking into account the proposed uses, it can be concluded with reasonable certainty that residues of dinotefuran in residential environments and in food and drinking water will not result in unacceptable levels of human health risk. 2. Infants and children. FFDCA section 407 provides that EPA shall apply an additional safety factor for infants and children to account for prenatal and postnatal toxicity and the completeness of the data base. Only when there is no indication of increased sensitivity of infants and children and when the data base is complete, may the extra safety factor be removed. In the case of dinotefuran, the toxicology data base is complete. There is no indication of increased sensitivity in the data base overall, and specifically, there is no indication of increased sensitivity in the developmental and multi generation reproductive toxicity studies. Therefore, Mitsui concludes that there is no need for an additional safety factor; the RfD of 1.27 mg/ kg/ day and sub chronic NOAEL of 307 mg/ kg/ day are protective of infants and children. Using the chronic exposure assumptions and the proposed RfD described above, the dietary exposure to dinotefuran for infants and children ( 1 to 6 years) was calculated to be 0.57% of the reference dose of 1.27 mg/ kg bwt/ day. The resulting DWLOC for nonnursing infants, 12,666 ppb, is much greater than the estimated average concentration of dinotefuran in surface water, 6.24 ppb. Using the intermediate term exposure assumptions and the proposed NOAEL described above, the intermediate term aggregate exposure to dinotefuran for the toddlers ( 1 to 3 years) resulted in an MOE of 1,410. The resulting DWLOC, 42,785 ppb, is much greater than the estimated average concentration of dinotefuran in surface water, 6.24 ppb. Therefore, taking into account the proposed uses, it can be concluded with reasonable certainty that residues of dinotefuran in residential environments and in food and drinking water will not result in unacceptable levels of human health risk.

F. International Tolerances No codex maximum residue levels have been established for residues of dinotefuran on any crops at this time.

[ FR Doc. 03   16737 Filed 7   1   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0226; FRL   7315   2]

Copper Hydroxide; Notice of Filing of a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP   2003   0226, must be received on or before August 1, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6304; e mail address: boyle. kathryn@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

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

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