[Federal Register Volume 87, Number 85 (Tuesday, May 3, 2022)]
[Proposed Rules]
[Pages 26147-26151]
[FR Doc No: 2022-09405]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-HQ-OAR-2022-0195; FRL-9631-02-OAR]
RIN 2060-AV66

Intended Air Quality Redesignation for the 2008 Lead National
Ambient Air Quality Standards; Canton, Ohio; Stark County, Ohio: Notice
of Availability and Public Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and public comment period.

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SUMMARY: The Environmental Protection Agency (EPA) is providing notice
of our intent to redesignate a portion of Canton, Ohio in northeastern
Stark County from ``unclassifiable/attainment'' to ``nonattainment''
for the 2008 National Ambient Air Quality Standards (NAAQS) for lead
(Pb). The EPA's intended redesignation of this portion of the Canton,
Ohio area is based on recorded violations of the Pb NAAQS at Ohio
Environmental Protection Agency's (Ohio EPA) Republic Steel ambient air
monitoring site located in Canton, Ohio, and additional relevant air
quality information. If the redesignation to nonattainment is
finalized, the state of Ohio would be required to undertake certain
planning requirements to reduce Pb concentrations within this
nonattainment area, including, but not limited to, the requirement to
submit within 18 months of redesignation, a revision to the Ohio state
implementation plan (SIP) that provides for attainment of the Pb
standards as expeditiously as practicable, but no later than 5 years
after the date of redesignation to nonattainment.
    Notice is hereby given that the EPA (Agency) has posted on our
public electronic docket and internet website the intended
redesignation for relevant portion of the Canton, Ohio (Stark County,
OH) area under the 2008 Pb NAAQS. The EPA invites the public to review
and provide input on our intended redesignation during the comment
period specified in the DATES section. The EPA notified the state of
Ohio of our intended redesignation action on or about April 26, 2022.
The EPA intends to make its final redesignation determination for the
Canton, Ohio area approximately 240 days from the date the Agency
notified the state of its intended designation, that is, in December
2022.

DATES: Comments must be received on or before June 2, 2022. Please
refer to SUPPLEMENTARY INFORMATION for additional information on the
comment period.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2022-0195, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Out of an abundance of caution
for members of the public and our staff, the EPA Docket Center and
Reading Room are closed to the public, with limited exceptions, to
reduce the risk of transmitting COVID-19. Our Docket Center staff will
continue to provide remote customer service via email, phone, and
webform. We encourage the public to submit comments via https://www.regulations.gov, as there may be a delay in processing mail and
faxes. Hand deliveries and couriers may be received by scheduled
appointment only. For further information on EPA

Docket Center services and the current status, please visit us online
at https://www.epa.gov/dockets.
    Once submitted, comments cannot be edited or removed from https://www.regulations.gov. The EPA may publish any comment received to our
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. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., comments hosted on the Web, Cloud, or
other file sharing system). For additional submission methods, the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For general questions concerning this
action, please contact Andrew Leith, U.S. EPA, Office of Air Quality
Planning and Standards, Air Quality Policy Division, C541A, Research
Triangle Park, NC 27709, telephone<PHONE_NUMBER>, email at
[email protected]. The following EPA Regional office contact can
answer questions specific to the Canton, Ohio area:
    Regional Office Contacts:

Region V--Alisa Liu<PHONE_NUMBER>, email at [email protected]

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              Regional office                       Affected state
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EPA Region 5, 77 West Jackson Blvd.,         Ohio.
 Chicago, IL 60604.
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    Although the EPA Region 5 office may be closed, or operating during
limited hours, to reduce the risk of transmitting COVID-19, staff
remain available via telephone and email. The EPA encourages the public
to review our recent letter notifying Ohio of our intended
redesignation action, and the associated area-specific technical
support information online at https://www.epa.gov/lead-designations and
in the public docket for these lead designations at http://www.regulations.gov under Docket ID No. EPA-HQ-OAR-2022-0195.

SUPPLEMENTARY INFORMATION: The information in this document is
organized as follows:

I. Purpose of Action and Instructions for Submitting Public Comments
II. The 2008 Pb NAAQS
III. Designations for the 2008 Pb NAAQS
IV. Applicable Regulatory Provisions
V. Monitoring Network Considerations
VI. Canton, Ohio Ambient Air Monitoring Site
VII. Pb Data Considerations
VIII. The EPA's Intended Decision To Address Monitored Pb Violations
in the Canton, Ohio Area Through Redesignation

I. Purpose of Action and Instructions for Submitting Public Comments

    The purpose of this notice of availability is to solicit input from
interested parties on the EPA's notification to the state of Ohio of
our intended redesignation determination for the Canton, Ohio area
(Stark County, Ohio) for the 2008 Pb NAAQS. The EPA's notification
letter and the supporting technical analyses can be found at https://www.epa.gov/lead-designations and also in the public docket for this
action at https://www.regulations.gov under Docket ID No. EPA-HQ-OAR-
2022-0195.
    The EPA invites public input regarding the Canton, OH area during
the 30-day comment period provided in this notice. To receive full
consideration, input from the public must be submitted to the docket by
June 2, 2022. This notice and opportunity for public comment does not
affect any rights or obligations of any state, or tribe, or of the EPA,
which might otherwise exist pursuant to the CAA section 107(d).
    CAA section 107(d)(3) provides a process for air quality
redesignations that involves recommendations by affected states,
territories, and tribes to the EPA and responses from the EPA to those
parties, prior to the EPA promulgating final area redesignation
decisions. The EPA is not required under the CAA section 107(d)(3) to
seek public comment during the redesignations process, but we are
electing to do so for this area with respect to the 2008 Pb NAAQS to
gather additional information for the EPA to consider before making
final redesignation decisions for the specific area addressed.
    1. Submitting CBI. Do not submit CBI information to the EPA through
https://www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI in a disk or CD ROM
that you mail to the 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 Code of Federal Regulations (CFR) part 2. Send or deliver
information identified as CBI only to the following address: Tiffany
Purifoy, OAQPS CBI Officer, U.S. EPA, Office of Air Quality Planning
and Standards, Mail Code C404-02, Research Triangle Park, NC 27711,
Attention Docket ID No. EPA-HQ-OAR-2022-0195. There will be a delay in
confirming receipt of CBI packages, because the EPA-RTP office is
closed to reduce the risk of transmitting COVID-19. Due to the office
closure, EPA is also requesting that parties notify the OAQPS Document
Control Officer via telephone,<PHONE_NUMBER>, or email at
[email protected] when mailing information identified as CBI.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.

II. The 2008 Pb NAAQS

    Under section 109 of the Clean Air Act (CAA or Act), the EPA has
established primary and secondary NAAQS for certain pervasive air
pollutants (referred to as ``criteria pollutants'') and conducts
periodic reviews of the NAAQS to determine whether they should be
revised or whether new NAAQS should be established. The primary NAAQS
represent ambient air quality standards, the attainment and maintenance
of which the EPA has determined, including a margin of safety, are
requisite to protect the public health. The secondary NAAQS represent
ambient air quality standards, the attainment and maintenance of which
the EPA has determined are requisite to protect the public welfare from
any known or anticipated adverse effects associated with the presence
of such air pollutant in the ambient air.
    Under the CAA, the EPA must establish NAAQS for criteria
pollutants, including Pb. Lead is generally emitted in the form of
particles that are deposited in water, soil, and dust. People may be
exposed to Pb by inhaling it or by ingesting Pb-

contaminated food, water, soil, or dust. Once in the body, Pb is
quickly absorbed into the bloodstream and can result in a broad range
of adverse health effects including damage to the central nervous
system, cardiovascular function, kidneys, immune system, and red blood
cells. Children are particularly vulnerable to Pb exposure, in part
because they are more likely to ingest Pb and in part because their
still-developing bodies are more sensitive to the effects of Pb. The
harmful effects to children's developing nervous systems (including
their brains) arising from Pb exposure may include intelligence
quotient (IQ) \1\ loss, poor academic achievement, long-term learning
disabilities, and an increased risk of delinquent behavior.\2\
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    \1\ IQ is a score created by dividing a person's mental age
score, obtained by administering an intelligence test, by the
person's chronological age, both expressed in terms of years and
months. ``Glossary of Important Assessment and Measurement Terms,''
Philadelphia, PA: National Council on Measurement in Education.
2016.
    \2\ Depending on the level of exposure, lead can adversely
affect the nervous system, kidney function, immune system,
reproductive and developmental systems and the cardiovascular
system. For more information regarding the health effects of Pb
exposure, see 73 FR 66964, November 12, 2008, or http://www.epa.gov/airquality/lead/health.html.
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    The EPA first established primary and secondary Pb standards in
1978 at 1.5 micrograms per cubic meter ([micro]g/m\3\) as a quarterly
average.\3\ Based on new health and scientific data, on October 15,
2008, the EPA revised the federal Pb standards to 0.15 [micro]g/m\3\
and revised the averaging time for the standards.\4\ Since the primary
and secondary Pb standards are the same, we refer to them hereafter in
this document using the singular Pb standard or NAAQS. A violation of
the 2008 Pb NAAQS occurs if any arithmetic 3-month mean concentration
is greater than 0.15 [micro]g/m\3\.\5\
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    \3\ 43 FR 46246 (October 5, 1978).
    \4\ 73 FR 66964 (November 12, 2008).
    \5\ 40 CFR 50.16.
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III. Designations for the 2008 Pb NAAQS

    Following promulgation of any new or revised NAAQS, the EPA is
required by CAA section 107(d) to designate areas throughout the nation
as attaining or not attaining the NAAQS. The EPA initially designated
all areas of the country as ``unclassifiable,'' ``unclassifiable/
attainment,'' or ``nonattainment'' for the 2008 Pb NAAQS in two rounds
on November 16, 2010, and November 8, 2011. In the November 8, 2011,
action, the EPA designated Stark County, along with the remaining areas
of Ohio, as unclassifiable/attainment.\6\
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    \6\ See 75 FR 71033 (November 22, 2010); 76 FR 72097 (November
22, 2011).
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    Pursuant to CAA section 107(d), the EPA must designate as
``nonattainment'' those areas that violate the NAAQS and those nearby
areas that contribute to violations. Once an area has been designated,
the EPA Administrator, under CAA section 107(d)(3), may at any time
notify a state that a designation should be revised. 42 U.S.C.
7407(d)(3).
    In 2021, the EPA determined that quality-assured, certified
monitoring data collected during 2017-2020 at the Ohio EPA ambient air
monitoring site located at 3150 Georgetown Road NE in Canton, Ohio
(Republic Steel ambient air monitoring site), showed that the area was
violating the Pb NAAQS. Accordingly, consistent with CAA section
107(d)(3)(A), the EPA notified the Governor of Ohio in a letter dated
April 26, 2022, of our intent to redesignate the relevant portion of
the Canton, Ohio area as ``nonattainment'' for the 2008 Pb NAAQS.

IV. Applicable Regulatory Provisions

    A determination of whether an area's air quality meets applicable
standards is generally based upon the most recent 3 years of complete,
quality-assured data gathered at established state and local air
monitoring stations (SLAMS) and entered into the EPA's Air Quality
System (AQS) database.\7\ Data from ambient air monitors operated by
state and local agencies in compliance with the EPA monitoring
requirements must be submitted to AQS.\8\ Monitoring agencies annually
certify that these data are accurate to the best of their knowledge.\9\
All data are reviewed to determine the area's air quality status for Pb
in accordance with 40 CFR part 50, Appendix R.
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    \7\ AQS is the EPA's repository of ambient air quality data.
    \8\ 40 CFR 58.16.
    \9\ 40 CFR 58.15.
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    Under the EPA regulations in 40 CFR 50.16 and in accordance with 40
CFR part 50 Appendix R, the 2008 Pb NAAQS is met when the design value
is less than or equal to 0.15 [micro]g/m\3\ at each eligible monitoring
site within the area. The Pb design value at each eligible monitoring
site is the maximum valid 3-month arithmetic mean Pb concentration from
the 38-month period consisting of the most recent 3-year calendar
period plus two previous months. The 3-month mean Pb concentrations are
rounded to the nearest hundredth [micro]g/m\3\ for comparison to the
NAAQS. Data completeness requirements for a given 3-month period are
met if the average of the data capture rate of the three constituent
monthly means is greater than or equal to 75 percent.\10\
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    \10\ See 40 CFR part 50, Appendix R sections (1)c, 4(c), and
5(b).
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V. Monitoring Network Considerations

    Section 110(a)(2)(B)(i) of the CAA requires states to establish and
operate air monitoring networks to compile data on ambient air quality
for all criteria pollutants. The EPA's monitoring requirements are
specified by regulation in 40 CFR part 58. These requirements are
applicable to state, and where delegated, local air monitoring agencies
that operate criteria pollutant monitors. The regulations in 40 CFR
part 58 establish specific requirements for operating air quality
surveillance networks to measure ambient concentrations of Pb,
including requirements for measurement methods, network design, quality
assurance procedures, and in the case of large urban areas, the minimum
number of monitoring sites designated as SLAMS.
    In sections 4.4 and 4.5 of Appendix D to 40 CFR part 58, the EPA
specifies minimum monitoring requirements for Pb, respectively, to
operate at SLAMS. SLAMS produce data that are eligible for comparison
with the NAAQS, and therefore, the monitor must be an approved federal
reference method (FRM), federal equivalent method (FEM), or approved
regional method (ARM) monitor.
    The minimum number of required Pb SLAMS is described in section 4.5
of Appendix D to 40 CFR part 58. There must be at least one source-
oriented SLAMS site located to measure the maximum Pb concentration in
ambient air resulting from each non-airport Pb source that emits 0.50
or more tons per year (tpy) and from each airport that emits 1.0 tpy or
more based on either the most recent National Emission Inventory (NEI)
or other scientifically justifiable methods and data.
    According to the 2017 NEI, one source in Stark County, Ohio
exceeded the 0.50 tpy threshold and therefore required source-oriented
Pb monitoring: The Republic Steel plant located at 2633 Eighth Street
NE in Canton, Ohio (Republic Steel).\11\ Republic Steel is a steel
manufacturer that manufactures leaded steel and other steel products.
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    \11\ Ohio facility-level Pb emissions data from the 2017 NEI may
be accessed on the EPA NEI website at https://www.epa.gov/air-emissions-inventories/2017-national-emissions-inventory-nei-data.

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VI. Canton, Ohio Ambient Air Monitoring Site

    On June 6, 2017, an ambient air monitoring site was installed and
began operating in Stark County to measure concentrations of Pb and
other toxic metals. Ohio EPA, through its partnership with the Canton
City Public Health Department, installed a special purpose monitor to
meet the requirements of a permit \12\ issued on December 12, 2016, to
Republic Steel as part of operational changes made to its plant at 2633
Eighth Street NE in Canton, Ohio.
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    \12\ Ohio EPA Air Pollution Permit-to-Install (PTI), Permit
Number: P0121793, Facility ID:<PHONE_NUMBER>, Republic Steel. http://wwwapp.epa.ohio.gov/dapc/permits_issued/1499790.pdf.
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    In April 2019, Ohio EPA converted the designated primary Pb sampler
at the Republic Steel ambient air monitoring site from a special
purpose monitor (SPM) to a SLAMS monitor. The conversion was made as a
result of Ohio EPA's 2017 emissions inventory, which indicated that
Republic Steel's Pb emissions were at 0.81 tpy, which exceeds the
source-oriented 0.50 tpy monitoring threshold in 40 CFR part 58
Appendix D. The EPA requires SLAMS monitors to collect Pb samples at a
minimum frequency of 1-in-6 days and those data be reported to the
EPA's AQS. Ohio EPA continued to also collect SPM samples to sample air
quality specifically during leaded production at the Republic Steel
plant; however, the SPM monitoring data is not reported to the EPA's
AQS. Ohio EPA posts the SLAMS and SPM data on its website.\13\
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    \13\ Ohio EPA, Air Pollution Control, Reports & Data, Special
Sampling Projects. https://epa.ohio.gov/wps/portal/gov/epa/divisions-and-offices/air-pollution-control/reports-and-data/special-sampling-projects.
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    Two ambient air quality monitors (Parameter Occurrence Code (POC 1,
POC 4) at the Republic Steel ambient air monitoring site measure
ambient concentrations on a microscale level of 0 to 100 meters with a
staggered schedule. POC 1 operates on the EPA sampling schedule of 1-
in-6 days, and POC 4 operates on a randomized schedule. The POC is used
to distinguish different instruments that measure the same parameter at
the same site.

VII. Pb Data Considerations

    In accordance with Appendix R to 40 CFR part 50, compliance with
the Pb NAAQS is determined based on data from 36 consecutive valid 3-
month periods (i.e., 38 months, or a 3-year calendar period and the
preceding November and December). As detailed in 40 CFR part 50
Appendix R section 4(c)(i), a 3-month mean Pb value is determined to be
valid (i.e., meets data completeness requirements) if the average of
the data capture rate of the three constituent monthly means is greater
than or equal to 75 percent.
    Under 40 CFR 58.15, monitoring agencies must certify, on an annual
basis, data collected at all SLAMS and at all FRM, FEM, and ARM special
purpose monitor stations that meet the EPA quality assurance
requirements. In doing so, monitoring agencies must certify that the
previous year of ambient concentration and quality assurance data are
completely submitted to AQS and that the ambient concentration data are
accurate to the best of their knowledge. Ohio EPA annually certifies
that the data it submits to AQS are quality-assured, including data
collected by Ohio EPA at the Republic Steel monitoring site.
    We have evaluated the completeness of these data in accordance with
the requirements of 40 CFR part 50 Appendix R. The data collected by
Ohio EPA at the Republic Steel ambient air monitoring site meet this
completeness criterion for each 3-month period from November 2018-
December 2020.
    Table 1 presents a summary of the latest available quality-assured
Pb monitoring data from the Republic Steel ambient air monitoring site.
A map showing the location of the monitor is included in the EPA's
Technical Support Document (EPA TSD), contained in the docket for this
rulemaking.

  Table 1--Ambient Air Quality Monitoring Data and Pb Design Values From Ohio EPA's Republic Steel Ambient Air
                                                 Monitoring Site
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                                           Maximum Pb 3-month rolling average * ([mu]g/      Pb design value *
                                                m\3\) (number of complete months in            ([mu]g/m\3\)
                 Monitor                                   parentheses)                  -----------------------
                                         ------------------------------------------------
                                             2017        2018        2019        2020      2017-2019   2018-2020
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AQS 39-151-0024: Republic Steel, 3150       0.11 (5)   0.20 (12)   0.21 (12)   0.13 (12)        0.21        0.21
 Georgetown Road NE, Canton, Ohio.......
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    The EPA considered the Pb NAAQS design value for the Republic Steel
ambient air monitoring site in Stark County by assessing the most
recent 3 consecutive years (i.e., 2018-2020) and two previous months of
quality-assured, certified ambient air quality data in the EPA's AQS
using data from FRM and/or FEM monitors that are sited and operated in
accordance with 40 CFR parts 50 and 58. Data collected at the Republic
Steel monitoring site indicate that the 2018-2020 design value
representative of the Stark County area is 0.21 [mu]g/m\3\. With a
design value of 0.21 [mu]g/m\3\, the Republic Steel ambient air
monitoring site shows a violation of the 2008 Pb NAAQS of 0.15 [mu]g/
m\3\ for 2018-2020.

VIII. The EPA's Intended Decision To Address Monitored Pb Violations in
the Canton, Ohio Area Through Redesignation

    The CAA provides the EPA with the authority to change the
designation of, or ``redesignate,'' areas in light of changes in
circumstances. More specifically, the EPA has the authority under CAA
section 107(d)(3) to redesignate areas (or portions thereof) on the
basis of air quality data, planning and control considerations, or any
other air quality-related considerations. Stark County shows a
violation of the 2008 Pb NAAQS based on data collected during 2018-
2020, and, therefore, under CAA section 107(d)(3), the EPA can notify
the state of its intent to redesignate to nonattainment all or some of
Stark County and possibly additional areas in surrounding counties. In
this action, EPA is providing notice of its intent to redesignate only
part of Stark County to nonattainment.
    Under CAA section 107(d)(3), the EPA Administrator may at any time
notify the Governor of any State that available information indicates
that the designation of any area or portion of an area within the State
should be revised. For purposes of this intended redesignations action,
EPA is following the same analytical steps applied in the initial area
designations process following promulgation of a new or revised NAAQS.
That is, under CAA section 107(d)(1)(A)(i), the statutory

authority for initial area designations, EPA must designate as
nonattainment any area that violates the NAAQS and any nearby area that
contributes to ambient air quality in the violating area. Air quality
data from 2018-2020 indicate that ambient Pb concentrations in Stark
County do not meet the NAAQS, and, therefore, some area in Stark County
and possibly additional areas in surrounding counties must be
redesignated as nonattainment. The absence of monitored violations in
nearby counties is not a sufficient reason to eliminate nearby counties
as candidates for nonattainment status.
    The technical analysis identified the monitor that was showing a
violation of the standards (``violating monitor'') and evaluated nearby
areas for contributions to ambient Pb concentrations in the area. To
determine the boundaries of an area where violations support a
nonattainment designation, the 2008 Final Rule for the Pb NAAQS adopted
guidance (2008 EPA Pb Guidance) stated that the perimeter of a county
containing the violating monitor would be the initial presumptive
boundary for nonattainment areas. If the intended boundaries are
smaller than the full county, the EPA requires a demonstration to show
that violations are not occurring in the excluded portions of the
county and that the excluded portions are not source areas that
contribute to the observed violations. To justify establishing either a
larger or smaller area, the 2008 EPA Pb Guidance indicated the
following eight factors should be considered.\14\
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    \14\ 73 FR 67033 (November 12, 2008).
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    (1) Air quality in potentially included versus excluded areas;
    (2) Emissions in areas potentially included versus excluded from
the nonattainment area;
    (3) Level of control of emission sources;
    (4) Population density and degree of urbanization including
commercial development in included versus excluded areas;
    (5) Expected growth (including extent, pattern, and rate of
growth);
    (6) Meteorology (weather/transport patterns);
    (7) Geography/topography (mountain ranges or other air basin
boundaries); and
    (8) Jurisdictional boundaries (e.g., counties, air districts,
reservations, etc.).
    In addition to an analysis of the eight factors above, states can
choose to recommend Pb nonattainment boundaries by using one, or a
combination of the following techniques:
     Qualitative analysis;
     Spatial interpolation of air quality monitoring data; or
     Air quality simulation by dispersion modeling.\15\
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    \15\ 73 FR 67033 (November 12, 2008).
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    The EPA's detailed evaluation of the violating monitoring site,
contributing sources, and intended area boundaries based on the weight
of evidence of the previously identified factors is included in the
TSD, which is located in the docket for this intended redesignations
action. EPA's intended boundaries of the relevant area encompass the
portions of Stark County that are bounded on the north by State Route
OH-153 (12th Street NE; Mahoning Road), on the east by Broadway Avenue,
on the south by State Route OH-172 (Tucarawas Street E; Lincoln Street
E), and the west by State Route OH-43--Northbound (Cherry Avenue NE). A
map showing the boundaries of our intended nonattainment area for
Canton, Ohio is included in the TSD.

Panagiotis E. Tsirigotis,
Director, Office of Air Quality Planning & Standards.
[FR Doc. 2022-09405 Filed 5-2-22; 8:45 am]
BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Andrew Ertman<PHONE_NUMBER>

PP #2E8069

	EPA has received a pesticide petition (2E8069) from Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201W,
Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
part 180 to establish new tolerances for pyraclostrobin, carbamic acid,
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-,
methyl ester and its metabolite methyl-N-[[[1-(4-chlorophenyl)
pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent
compound in or on the raw agricultural commodity Artichoke, globe at 3.0
parts per million (ppm); Endive, Belgium at 3.0 ppm; Persimmon at 3.0
ppm; and updating existing crop groups to Vegetable, bulb, group 3-07 at
0.9 ppm; Vegetable, fruiting, group 8-10 at 1.4 ppm; Fruit, citrus,
group 10-10 at 2.0 ppm; Fruit, pome, group 11-10 at 1.5 ppm; Oilseed,
group 20 at 0.45 ppm; Caneberry subgroup 13-07A at 4.0 ppm; Bushberry
Subgroup 13-07B at 4.0 ppm; Small fruit, vine climbing subgroup (except
fuzzy kiwi) 13-07F at 2.0 ppm; and Low growing berry subgroup 13-07G at
1.2 ppm; and to amend 40 CFR part 180 by removing a tolerance for
residues of  [pyraclostrobin, carbamic acid,
[2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-,
methyl ester and its metabolite methyl-N-[[[1-(4-chlorophenyl)
pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent
compound] in or on the raw agricultural commodity Berry, group 13 at 4.0
ppm; Fruit, citrus, group 10 at 2.0 ppm; Fruit, pome, group 11 at 1.5
ppm; Grape at 2.0 ppm; Strawberry at 1.2 ppm; Vegetable, bulb, group 3
at 0.9 ppm; Vegetable, fruiting, group 8 at 1.4 ppm; Borage, seed at
0.45 ppm; Castor oil plant, seed at 0.45 ppm; Chinese tallowtree, seed
at 0.45 ppm; Crambe, seed at 0.45 ppm; Cuphea, seed at 0.45 ppm; Echium,
seed at 0.45 ppm; Euphorbia, seed at 0.45 ppm; Evening primrose, seed at
0.45 ppm; Flax seed at 0.45 ppm; Gold of pleasure, seed at 0.45 ppm;
Hare’s ear mustard, seed at 0.45 ppm, Jojoba, seed at 0.45 ppm;
Lesquerella, seed at 0.45 ppm, Lunaria, seed at 0.45 ppm; Meadowfoam,
seed at 0.45 ppm; Milkweed, seed at 0.45 ppm; Mustard, seed at 0.45 ppm;
Niger seed, seed at 0.45 ppm; Oil radish, seed at 0.45 ppm; Poppy, seed
at 0.45 ppm; Rapeseed, seed at 0.45 ppm; Rose hip, seed at 0.45 ppm;
Safflower, seed at 0.45 ppm; Sesame, seed at 0.45 ppm; Stokes aster,
seed at 0.45 ppm; Sunflower, seed at 0.45 ppm; Sweet rocket, seed at
0.45 ppm, Tallowwood, seed at 0.45 ppm, Tea oil plant, seed at 0.45 ppm,
and Vernonia, seed at 0.45 ppm.  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Plant and animal metabolism. Nature of the residue
studies (OPPTS 860.1300) were conducted in grape, potato and wheat as
representative crops in order to characterize the fate of pyraclostrobin
in all crop matrices.  Pyraclostrobin demonstrated a similar pathway and
fate in all three crops. In all three crops the pyraclostrobin Residues
of Concern (ROC) of were characterized as parent (pyraclostrobin) and
BAS 500-3), methyl-N[[[1-(4-chlorophenyl) pyrazol-3yl]oxy]o-tolyl]
carbamate.  In hens the residues of concern were determined to be parent
compound and a hydroxlated metabolite, BAS 500-16.  In goats the
residues of concern were determined to be parent and a hydroxylated
metabolite BAS 500-10.

	2. Analytical method. In plants the method of analysis is aqueous
organic solvent extraction, column clean up and quantitation by
LC/MS/MS.  In animals the method of analysis involves base hydrolysis,
organic extraction, column clean up and quantitation by LC/MS/MS or
derivatization (methylation) followed by quantitation by GC/MS.

	3. Magnitude of residues. Field trials were carried out in order to
determine the magnitude of the residues in globe artichoke, globe;
endive, Blegium; and persimmon, to satisfy the requirements for a
tolerance of pyraclostrobin in these commodities.  Field trials were
carried out using the maximum proposed labeled rate, maximum proposed
number of applications, and the minimum proposed pre-harvest interval.
No additional data were needed in support of residues in meat, milk,
poultry and eggs.

B. Toxicological Profile

	1. Acute toxicity. Pyraclostrobin and its formulated products have
favorable acute toxicity. The acute toxicity studies place technical
pyraclostrobin in toxicity category IV for acute oral and acute
inhalation and category III for acute dermal.  Pyraclostrobin is
category III for both eye and skin irritation, and it is not a dermal
sensitizer.  Two formulated end use products are proposed, an
Emulsifiable Concentrate (EC) and an Extruded Granule (EG).  The EC has
an acute oral toxicity category of II, acute dermal of III, acute
inhalation of IV, eye and skin irritation categories of III, and is not
a dermal sensitizer.  The EG has acute oral and dermal toxicity
categories of III, acute inhalation of IV, eye irritation of III, skin
irritation of IV and is not a dermal sensitizer.

	2. Genotoxicty. Pyraclostrobin was negative for inducing mutations in
both an in vitro Ames test and an in vitro CHO/HGPRT Locus Mammalian
Cell Mutation Assay.  Pyraclostrobin also demonstrated no chromosomal
effects in an in vitro V79 Cells CHO Cytogenetic Assay and an in vivo
Mouse Micronucleus test.  An additional in vitro study investigating DNA
damage and repair also showed no effects. Pyraclostrobin has been tested
in a total of 5 genetic toxicology assays consisting of in vitro and in
vivo studies.  It can be stated that pyraclostrobin did not show any
mutagenic, clastogenic or other genotoxic activity when tested under the
conditions of the studies mentioned above.  Therefore, pyraclostrobin
does not pose a genotoxic hazard to humans.

	3. Reproductive and developmental toxicity. The reproductive and
developmental toxicity of pyraclostrobin was investigated in a
2-generation rat reproduction study as well as in rat and rabbit
teratology studies.  There were no adverse effects on reproduction,
systemic toxicity to adults or developmental toxicity in the
two-generation study so the NOAEL is the highest dose tested of 300 ppm
(approximately 32.6 mg/kg bw/day).

No teratogenic effects were noted in either the rat or rabbit
developmental studies.  In the rat study, maternal toxicity observed at
the mid and high dose consisted of decreased food consumption and body
weight gain.  Developmental changes noted at the high dose were
increased incidences of dilated renal pelvis and cervical ribs with no
cartilage.  The maternal NOAEL was 10 mg/kg bw and the developmental
NOAEL was 25 mg/kg bw.

In the rabbit teratology study, maternal toxicity observed at the mid
and high doses consisted of decreased food consumption and body weight
gain (severe at the high dose).  An increased postimplantation loss was
also observed at the mid and high doses due to an increase in early
resorptions.  In rabbits, these types of effects are often observed with
significant stress on the mothers (as seen by the body weight gain
decrease in this study) and not indicative of frank developmental
toxicity.  The NOAEL for both maternal and developmental toxicity was 5
mg/kg bw.

	4. Subchronic toxicity. The subchronic toxicity of pyraclostrobin was
investigated in 90-day feeding studies with rats, mice and dogs, and in
a 28-day dermal administration study in rats.  A 90-day neurotoxicity
study in rats was also performed.  Generally, mild toxicity was
observed.  At high dose levels in feeding studies, general findings in
all three species were decreased food consumption and body weight gain
and a thickening of the duodenum.  Anemia occurred at high dose levels
in both rats and mice with accompanying extramedullary hematopoiesis of
the spleen in rats.  In rats only, a finding of liver cell hypertrophy
was indicative of a physiological response to the handling of the
chemical.   The lowest NOAEL in the 90-day feeding studies was from the
dog study and determined to be 5.8 mg/kg bw/day.

In the 28-day repeat dose dermal study, no systemic effects were noted
up to the highest dose tested of 250 mg/kg bw/day.

In a 90-day rat neurotoxicity study, a direct neurotoxic effect was not
observed.

	5. Chronic toxicity. Pyraclostrobin was administered to groups of 5
male and 5 female purebred Beagle dogs in the diet at concentrations of
0, 100, 200 and 400 ppm over a period of 12 months.   Signs of toxicity
were observed at the high dose.  Diarrhea was observed throughout the
study period for both sexes. High dose males and females initially lost
weight and body weight gain was decreased for the entire study period
for females.  Hematological changes observed were an increase in white
blood cells in males, and an increase in platelets in both sexes at the
high dose.  Clinical chemistry demonstrated a decrease in serum total
protein, albumin, globulins and cholesterol in high dose animals of both
sexes possibly due to the diarrhea and reduced nutritional status of the
animals.  The NOAEL was 200 ppm (ca. 5.5 mg/kg bw/day males; 5.4 mg/kg
bw/day females).

In an oncogenicity study, pyraclostrobin was administered to groups of
50 male and 50 female Wistar rats at dietary concentrations of 0; 25;
75, and 200 ppm for 24 months.  In a companion chronic toxicity study,
20 rats/sex were used at the same dose levels as in the oncogenicity
study.  A body weight gain depression of 10-11% in males and 14-22% in
females with an accompanying decrease in food efficiency was observed at
the high dose.  There was no evidence that pyraclostrobin produced a
carcinogenic effect in rats.  The NOAEL for the chronic rat and the
cancer rat study is 75 ppm (ca. 3.4 mg/kg bw/day males; 4.7 mg/kg bw/day
females).

Pyraclostrobin was administered to groups of 50 male and 50 female
B6C3F1 mice at dietary concentrations of 0, 10, 30, 120 and 180 ppm
(females only) for 18 months.  Body weights were reduced at the highest
doses tested in both males and females.  At the high dose, body weight
gain decreases of 27% in females and 29% in males with an accompanying
decrease in food efficiency were observed.  No other signs of toxicity
were noted at any dose level.  The NOAEL  was found to be 30 ppm (ca.
4.1 mg/kg bw/day) for males. The Agency determined that the body weight
effect at the high dose in females was not sufficient to determine an
MTD.  Therefore the NOAEL for females is considered greater than the
highest dose tested of 32.8 mg/kg bw/day.   There was no evidence that
pyraclostrobin produced a carcinogenic effect in mice.

	6. Animal metabolism. In a rat metabolism study with pyraclostrobin,
10-13% of the administered dose was excreted in the urine and 74-91% in
the feces within 48 hours.  Excretion via bile was significant
accounting for 35-38% of the administered dose. By 120 hours after
dosing, very little radioactivity remained in tissues. Pyraclostrobin
was rapidly and almost completely metabolized.  Very little unchanged
parent was detected.  The phase one biotransformation is characterized
by N-demethoxylation, various hydroxylations, cleavage of the ether bond
and further oxidation of the two resulting molecule parts.  Conjugation
of the formed hydroxyl groups by glucuronic acid or sulfate also
occurred. In summary, pyraclostrobin is extensively metabolized and
rapidly eliminated primarily via the bile, with no evidence of
accumulation in tissues.

	7. Metabolite toxicology. A comparison of the rat metabolism results
with the plant metabolism/residue results indicates that toxicology
studies performed with the parent pyraclostrobin are sufficient to cover
dietary exposure.  Plant residues are primarily the parent compound with
a fraction (up to 10-20% at most) being the demethoxylated parent.  This
metabolite is referred to as BF 500-3 in the plant studies and as 500M07
in the rat study.  This metabolite in the rat is the first step in the
major biotransformation process leading to the majority of the
metabolites determined in the major excretion pathway.

	8. Endocrine disruption. Endocrine effects. No specific tests have been
conducted with pyraclostrobin to determine whether the chemical may have
an effect in humans that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects.  However, there were no
significant findings in other relevant toxicity studies (i.e.,
subchronic and chronic toxicity, teratology and multi-generation
reproductive studies) which would suggest that pyraclostrobin produces
endocrine related effects.

C. Aggregate Exposure

	1. Dietary exposure. Exposure assessments were conducted to evaluate
the potential risk due to acute and chronic dietary exposure of the U.S.
population and all sub-populations. The consumption data was from the
NHANES 2-day food consumption data for 2003 to 2008  and the assessment
was performed using the Dietary Exposure Evaluation Module (DEEM-FCID)
software version 3.14. An assessment for water in the diet was performed
in a separate analysis. The assessments used 100 % crop treated and
included all commodities with established tolerances and proposed
tolerances submitted in May 2012 and the commodities proposed in this
submission for tolerances as follows: artichoke, Belgium endive and
persimmon.  In addition tolerances for the following recently
established groups or subgroups were used as follows: Berry and small
fruit crop group 13-07,  Fruit, citrus, crop group 10-10, Fruit, pome,
crop group 11-10, Oilseed, crop group 20, Vegetable, bulb, crop group
3-07, Vegetable, fruiting crop group 8-10. The impact of the new
commodities on the animal Maximum Reasonably Balanced Diets was minimal
and thus no changes in tolerances in animal commodities are proposed.

	i. Food. Acute Dietary Exposure Assessment

The inputs for previously registered commodities were based on tolerance
values or highest average field trial (HAFT) residues as used in the
acute dietary assessment conducted as part of the evaluation by EPA in
February 11, 2008 (DP Number 348308).  A few input values were changed
from the 2008 evaluation as follows: the HAFT of 10.7 mg/kg was used for
the whole subgroup 4B (as was done in the EPA 2005 analysis) rather than
just for celery;  the HAFT of 14.4 mg/kg was used for the radicchio (as
was done in the EPA 2005 analysis) in addition to head lettuce;  the
HAFT of 21.2 mg/kg rather than 20.1was used for the leaf lettuce; the
group tolerance of 2.5 was used for all stone fruit; the group tolerance
of 0.45 was used for all oilseed except cotton seed. Process factors
derived from experimental studies that differed from those used in the
2008 evaluation were used as follows: grape juice = 0.14, tomato paste =
0.6, tomato puree = 0.3, tomato juice = 0.3.

The resulting exposure estimates were compared against the
pyraclostrobin (BAS 500 F) acute Population Adjusted Dose (aPAD) of 3.00
mg/kg b.w./day for all populations except females age 13-49 years with
an aPAD of 0.05 mg/kg b.w./day. The most highly exposed sub-population
was females 13-49 years old with 84.3 % utilization of the aPAD. The
results of the acute dietary assessment are presented in Table 1.

Table 1. Results for Pyraclostrobin (BAS 500 F) Acute Dietary Exposure
(Food only) Considering all Current and Proposed Tolerances using
DEEM-FCID at the 95th Percentile

Population	Exposure Estimate	% aRfD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.042652	1.42

All Infants (< 1 year old)	0.055319	1.84

Children (1-2 years old)	0.079562	2.65

Children (3-5 years old)	0.070094	2.34

Children (6-12 years old)	0.041602	1.39

Youth (13-19 years old)	0.030026	1.00

Adults (20-49 years old)	0.039469	1.32

Adults (50+ years old)	0.039328	1.31

Females (13-49 years old)	0.042158	84.32

The results of the analysis show that for all populations, the estimated
exposures are below the Agency's level of concern (< 100% aPAD).
Additional refinements in the dietary risk assessment (i.e. utilizing
additional anticipated residue values, percent crop treated values)
would further reduce the estimated exposure values.

Chronic Dietary Exposure Assessment

The inputs for previously registered commodities were based on tolerance
values or average field trial residues as used in the chronic dietary
assessment conducted as part of the evaluation by EPA in February 11,
2008 (DP Number 348308).  A few input values were changed from the 2008
evaluation as follows: the HAFT of 0.21 mg/kg was used for the subgroup
6C (except chickpea, guar and lentil at 0.34 mg/kg) rather than the
tolerance; the group tolerance of 2.5 was used for all stone fruit; the
group tolerance of 0.45 was used for all oilseed except cotton seed.
Process factors derived from experimental studies that differed from
those used in the 2008 evaluation were used as follows: grape juice =
0.14, tomato paste = 0.6, tomato puree = 0.3, tomato juice = 0.3.

The resulting exposure estimates were compared against the
pyraclostrobin chronic Population Adjusted Dose (cPAD) for the U.S.
population and all sub-populations of 0.034 mg/kg bw/day. This endpoint
is based on the NOAEL value of 3.4 mg/kg bw/day using a FQPA safety
factor of 1.  The most highly exposed population sub-group was children
1-2 years of age which utilized 55.8% cPAD.  The results of the chronic
dietary assessment (food only) are presented in Table 2.

Table 2.  Results for Pyraclostrobin (BAS 500 F) Chronic Dietary
Exposure (Food  only) Considering All  Commodities using DEEM-FCID

Population	Exposure Estimate	% cPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.006239	18.4

All Infants (< 1 year old)	0.011203	33.0

Children (1-2 years old)	0.018972	55.8

Children (3-5 years old)	0.013556	39.9

Children (6-12 years old)	0.007481	22.0

Youth (13-19 years old)	0.003982	11.7

Adults (20-49 years old)	0.005205	15.3

Adults (50+ years old)	0.005617	16.5

Females (13-49 years old)	0.005012	14.7

The results of the risk assessment show that for all populations the
exposures are below a level of concern (< 100% cPAD). Additional
refinements in the dietary risk assessment (i.e. utilizing anticipated
residue values, percent crop treated values) would further reduce the
estimated exposure values.

	ii. Drinking water. The water exposure values used for this analysis
are from the most recent EPA assessment for pyraclostrobin (February 11,
2008, “Pyraclostrobin. Acute and Chronic Aggregate Dietary (Food and
Drinking water) Exposure and Risk Assessment to Support new Uses on Oat
Grain, Barley, Oilseed (Crop group 20), Fresh Herbs (Herbs Subgroup
10=9A), Avocado, Black Sapote, Canistel, Mamey Spoted, Mango, Papaya,
Sapodilla, and Star Apple.”  The highest water exposure values were
from aerial application on ornamentals which resulted in an acute
exposure of 35.6 ug/L and chronic exposure of 2.3 ug/L.  These water
exposure values are greater than the exposure from the current uses and
the proposed new uses.

Acute: The highest acute Estimated Drinking Water Concentration (EDWC)
for pyraclostrobin (BAS 500 F) was estimated to be 35.6 µg/L (ppb) in
surface water.  The analysis was performed using DEEM-FCID software
version 3.14 with the residue concentration in water set at 0.0356 mg/L
based on the surface water concentration determined for the nursery use.
The resulting exposure estimates were compared against the
pyraclostrobin (BAS 500 F) acute Population Adjusted Dose (aPAD) of 3.00
mg/kg b.w./day for all populations except females age 13-49 years with
an aPAD of 0.05 mg/kg b.w./day. The most highly exposed sub-population
was females 13-49 years old with 3.9 % utilization of the aPAD. The
results of the acute dietary assessment for water are presented in Table
3.

Table 3. Results for Pyraclostrobin (BAS 500 F) Acute Dietary Exposure
(Water only) Considering all Current and Proposed Uses using DEEM-FCID
at the 95th Percentile

Population	Exposure Estimate	% aRfD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.001941	0.06

All Infants (< 1 year old)	0.00608	0.20

Children (1-2 years old)	0.002993	0.10

Children (3-5 years old)	0.002429	0.08

Children (6-12 years old)	0.001856	0.06

Youth (13-19 years old)	0.001617	0.05

Adults (20-49 years old)	0.00191	0.06

Adults (50+ years old)	0.001702	0.06

Females (13-49 years old)	0.001937	3.87

Chronic: The highest chronic Estimated Drinking Water Concentration
(EDWC) for pyraclostrobin (BAS 500 F) was estimated to be 2.3 µg/L
(ppb) in surface water.  The analysis was performed using DEEM-FCID
software version 3.14 with the residue concentration in water set at
0.0023 mg/L based on the surface water concentration determined for the
nursery use. The resulting exposure estimates were compared against the
pyraclostrobin chronic Population Adjusted Dose (cPAD) for the U.S.
population and all sub-populations of 0.034 mg/kg bw/day. The most
highly exposed population sub-group was infants less than 1 year of age
which utilized 0.4% cPAD.  The results of the chronic dietary assessment
(water only) are presented in Table 4.

Table 4.  Results for Pyraclostrobin (BAS 500 F) Chronic Dietary
Exposure (Water  only) Considering all Current and Proposed Uses using
DEEM-FCID

Population	Exposure Estimate	% cPAD

Subgroups	(mg/kg b.w./day)

	U.S. Population	0.000048	0.1

All Infants (< 1 year old)	0.000124	0.4

Children (1-2 years old)	0.000069	0.2

Children (3-5 years old)	0.000059	0.2

Children (6-12 years old)	0.000042	0.1

Youth (13-19 years old)	0.000035	0.1

Adults (20-49 years old)	0.000048	0.1

Adults (50+ years old)	0.000048	0.1

Females (13-49 years old)	0.000048	0.1

Acute Aggregate Exposure and Risk (Food and water)

The aggregate acute risk includes residues of pyraclostrobin from food
and water (Table 5). Exposures from residential uses are not included in
the acute aggregate assessment.  The results demonstrate that there are
no safety concerns for any subpopulation based on established and new
uses, and that the results clearly meet the FQPA standard of reasonable
certainty of no harm.

Table 5. 	Estimated Acute Aggregate Exposure and Risk of Pyraclostrobin
(Food and Drinking Water)

Population Subgroup	Food Exposure (mg/kg/day)	Water Exposure (mg/kg/day)
Total Exposure (mg/kg/day)	% aPAD

U.S. Population	0.042652	0.001941	0.044593	1.5

All Infants (< 1 yr old)	0.055319	0.006080	0.085642	2.9

Children 1-2 years	0.079562	0.002993	0.073087	2.4

Children 3-5 years	0.070094	0.002429	0.044031	1.5

Children 6 – 12 years	0.041602	0.001856	0.031882	1.1

Youth 13-19 years	0.030026	0.001617	0.041086	1.4

Females 13-49 years	0.042158	0.001937	0.044095	88.2

Adults 20-49 years	0.039469	0.001910	0.041238	1.4

Adults + 50	0.039328	0.001702	0.043860	1.5

Short- and Intermediate Term Aggregate Exposure and Risk (food, water,
and residential)

Short-term aggregate risk from pyraclostrobin takes into account
exposures from dietary consumption (food and water) and residential
exposure from turf use.  Post application exposure from the turf use is
considered short-term.  The aggregate MOEs from food, water, and
residential exposure are 105 and 229 for children 1-2 years old and the
US population, respectively.  These MOEs are greater than the target MOE
of 100 which indicates there is no safety concern.  The results of the
analysis are shown in Table 6.

Table 6. 	Estimated Short/Intermediate Term Aggregate Exposure and Risk
of Pyraclostrobin (Food, Drinking Water, and Residential exposure)

Population	Target MOE1	Food Exposure (mg/kg/day)	Water Exposure
(mg/kg/day)	Residential Exposure (mg/kg/day)	Total Exposure (mg/kg/day)
MOE2

US	100	0.00624	0.000048	0.0190	0.0253	229

Child 1-2 yr old	100	0.01897	0.000069	0.0364	0.0554	105

1 Target MOE is 100.

2 Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure), NOAEL
= 5.8 mg/kg b.w./day.

 Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of pyraclostrobin from food
and water (Table 7). Exposures from residential uses are not included in
the chronic aggregate assessment.  The results demonstrate there are no
safety concerns for any subpopulation based on established and new uses,
and that the results clearly meet the FQPA standard of reasonable
certainty of no harm.

  Table 7. 	Estimated Chronic Aggregate Exposure and Risk of
Pyraclostrobin (Food and Drinkiing water)

Population Subgroup	Food Exposure (mg/kg/day)	Water Exposure (mg/kg/day)
Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.006239	0.000048	0.006287	18.5

All Infants (< 1 yr old)	0.011203	0.000124	0.011327	33.3

Children 1-2 years	0.018972	0.000069	0.019041	56.0

Children 3-5 years	0.013556	0.000059	0.019031	56.0

Children 6 – 12 years	0.007481	0.000042	0.007523	22.1

Youth 13-19 years	0.003982	0.000035	0.004017	11.8

Females 13-49 years	0.005012	0.000048	0.005060	14.9

Adults 20-49 years	0.005205	0.000048	0.005253	15.5

Adults + 50	0.005617	0.000048	0.005665	16.7

	2. Non-dietary exposure.

Pyraclostrobin is registered for use on residential and recreational
turf.  The applications to turf will be made only by professional pest
control operators.  Therefore, residential handler exposure was not
evaluated.  The exposure assessment cited in this notice of filing was
transcribed from the Federal Register Notice on pyraclostrobin (U.S. EPA
final rule published in the Federal Register October 29, 2004 [Vol 69,
No. 209, p 63083 – 63100).  The EPA evaluated the following
post-application exposure scenarios 1) adults and toddler
post-application dermal exposure 2) toddlers’ incidental ingestion of
pesticide residues on lawns form hand-to-mouth transfer, 3) toddlers’
object-to-mouth transfer from mouthing pesticide-treated turfgrass, and
4) toddlers’ incidental ingestion of soil from pesticide-treated
residential areas.  A dermal absorption value of 14% was used in the
assessment of pyraclostrobin. The exposure and risk estimates for the
residential exposure scenarios are assessed for the day of application
because adults and toddlers could contact treated turf immediately after
application.  All short-/intermediate term MOEs were greater than 100
which indicates that exposure from all residential scenarios result in
exposures below a level of concern.

D. Cumulative Effects Section 408(b)(2)(D)(v) requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances that
have a common mechanism of toxicity.'  Pyraclostrobin is a foliar
fungicide which belongs to the class of strobilurin chemistry.  It is a
synthetic analog of strobilurin A, a naturally occurring antifungal
metabolite of the mushroom Strobillurus tenacellus (Anke et. al., 1977).
The active ingredient acts in the fungal cell through inhibition of
electron transport in the mitochondrial respiratory chain at the
position of the cytochrome-bc1 complex.  The protective effect is due to
the resultant death of the fungal cells by disorganization of the fungal
membrane system.  Pyraclostrobin also acts curatively to prevent the
increase and spread of fungal infections by inhibiting mycelial growth
and sporulation on the leaf surface. Pyraclostrobin inhibits spore
germination, germ tube growth and penetration into the host tissues

The EPA is currently developing methodology to perform cumulative risk
assessments.  At this time, there is no available data to determine
whether pyraclostrobin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
pyraclostrobin does not appear to produce a toxic metabolite common to
other substances.

E. Safety Determination

	1. U.S. population. Based on this risk assessment, BASF concludes that
there is a reasonable certainty that no harm will result to the general
population from the aggregate exposure to pyraclostrobin from the
existing and proposed new uses.

	2. Infants and children. Based on this risk assessment, BASF concludes
that there is a reasonable certainty that no harm will result to infants
or children from the aggregate exposure to pyraclostrobin from the
existing and proposed new uses.

F. International Tolerances

	No Codex maximum residue levels (MRLs) have been established for
residues of pyraclostrobin.  Therefore, no tolerance discrepancies exist
between countries for this chemical.

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