[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46766-46767]
[FR Doc No: 2012-19091]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2012-0026]

Public Meeting To Discuss Revision of ``Criteria for Preparation
and Evaluation of Radiological Emergency Response Plans and
Preparedness in Support of Nuclear Power Plants'' (NUREG-0654/FEMA-REP-
1, Rev. 1)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of public meetings.

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SUMMARY: The Federal Emergency Management Agency (FEMA) and the U.S.
Nuclear Regulatory Commission (NRC) will hold two public meetings to
solicit input from stakeholders and interested members of the public on
the scope of a proposed revision of ``Criteria for Preparation and
Evaluation of Radiological Emergency Response Plans and Preparedness in
Support of Nuclear Power Plants,'' NUREG-0654/FEMA-REP-1, Rev. 1.

DATES: The first meeting will be held on Wednesday, August 22, 2012
from 1 p.m. to 5 p.m. (CST) in Kansas City, Missouri. The second
meeting will be held on Thursday, September 13, 2012 from 1 p.m. to 5
p.m. (EST) in Rockville, MD. Please note that meetings may close early
if all business is finished.

ADDRESSES: The first meeting on August 22, 2012 will be held at USDA
Center, 6501 Beacon Drive, Kansas City, Missouri 64133; the second
meeting on September 13, 2012 will be held at NRC Headquarters, 11555
Rockville Pike, Rockville, MD 20852.
    Tele- and Web conferencing: Interested members of the public unable
to attend the meeting may participate by telephone via a toll-free
teleconference or remotely on the internet by web conference. To
participate in the meeting by teleconference or web conference, please
call or email the contact person listed below in the FOR FURTHER
INFORMATION CONTACT section as soon as possible, but no later than
three (3) business days before each meeting date.
    Comments: To facilitate public participation, we are inviting
public comment on the issues to be considered at the public meeting as
listed in the SUPPLEMENTARY INFORMATION section. To make oral
statements at the public meeting, please send a request to the contact
person listed under the FOR FURTHER INFORMATION CONTACT section by
close of business August 17, 2012 for the first meeting and by
September 7, 2012 for the second meeting. Written comments must be
submitted no later than August 17, 2012 for the Kansas City, MO meeting
and September 7, 2012 for the Rockville, MD meeting and must be
identified by Docket ID FEMA-2012-0026. Comments may be submitted by
one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    Mail/Hand Delivery/Courier: FEMA, Regulatory Affairs Division,
Office of Chief Counsel, 500 C Street, SW., Room 840, Washington, DC
20472-3100.
    Instructions: All submissions received must include the agency name
and docket ID. Regardless of the method used for submitting comments or
material, all submissions will be posted, without change, to the
Federal e-Rulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Therefore, submitting
this information makes it public. Please be aware that anyone is able
to search the electronic form of all comments received into any of our
dockets by the name of the individual who submitted the comment (or
signed the comment, if submitted on behalf of an association, business,
labor union, etc.). You may want to review the Federal Docket
Management System of records notice published in the Federal Register
on March 24, 2005 (70 FR 15086).
    Do not submit comments that include trade secrets, confidential
commercial or financial information to the public regulatory docket.
Comments containing this type of information should be appropriately
marked as containing such information and submitted by mail to the
address specified in the ADDRESSES section of this notice. If FEMA
receives a request to examine or copy this information, FEMA will treat
it as any other request under the Freedom of Information Act (FOIA), 5
U.S.C. 552, and the Department of Homeland Security (DHS)'s FOIA
regulation found in 6 Code of Federal Regulations (CFR) Part 5 and
FEMA's regulations found in 44 CFR part 5.
    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://www.regulations.gov, click on ``Advanced Search,'' then enter ``FEMA-
2012-0026'' in the ``By Docket ID'' box, then select ``FEMA'' under
``By Agency,'' and then click ``Search.'' Submitted comments may also
be inspected at FEMA, Office of Chief Counsel, Room 835, 500 C Street
SW., Washington, DC 20472.

FOR FURTHER INFORMATION CONTACT: Lou DeGilio, Emergency Management
Specialist, Radiological Emergency Preparedness Branch, Technological
Hazards Division, National Preparedness Directorate, Federal Emergency
Management Agency; Email<EMAIL_ADDRESS>Phone Number: 202-212-
2313.

SUPPLEMENTARY INFORMATION: The two meetings will be conducted jointly
by the NRC and FEMA, to solicit input from stakeholders and interested
members of the public on the scope of a proposed revision to ``Criteria
for Preparation and Evaluation of Radiological Emergency Response Plans
and Preparedness in Support of Nuclear Power Plants,'' NUREG-0654/FEMA-
REP-1, Rev. 1. The document is available online at http://www.regulations.gov (Docket ID FEMA-2012-0026).

    NUREG-0654/FEMA-REP-1, Rev.1 is a joint NRC/FEMA policy document
that provides guidance on the sixteen Planning Standards referenced in
FEMA's regulations at 44 CFR 350.5, and the NRC's regulations at 10 CFR
part 50. Both agencies use these Planning Standards, and associated
Evaluation Criteria, to evaluate the adequacy of emergency preparedness
plans of commercial nuclear power plant owners and operators, and the
State, local, and Tribal jurisdictions in which commercial nuclear
power plants are sited.
    Since the publication of NUREG-0654/FEMA-REP-1, Rev.1 in November
1980, four supplementary documents and one addendum have been issued
that update and modify specific planning and procedural elements. These
documents are available online at http://www.regulations.gov (Docket ID
FEMA-2012-0026). Considering stakeholder interest and the various
emergency planning and preparedness lessons learned since its initial
publication, FEMA and the NRC are considering revising NUREG-0654/FEMA-
REP-1, Rev.1.
    The purpose of these public meetings is to: (1) Solicit input from
stakeholders and interested members of the public on the scope of
future revisions to NUREG-0654/FEMA-REP-1, Rev.1; (2) describe the
proposed timeline for the revisions to NUREG-0654/FEMA-REP-1, Rev.1;
and (3) promote transparency, public participation, and collaboration
during the NUREG-0654/FEMA-REP-1, Rev.1 revision process. To make oral
statements at the public meeting, please send a request to the contact
person listed under the FOR FURTHER INFORMATION CONTACT section by
close of business August 17, 2012 for the first meeting and by
September 7, 2012 for the second meeting.

Information on Services for Individuals With Disabilities

    FEMA provides reasonable accommodations to individuals with
disabilities where appropriate. If you need a reasonable accommodation
to participate in this meeting (e.g., sign language), or need this
meeting notice or other information from the meeting in another format,
please notify the person listed above in the FOR FURTHER INFORMATION
CONTACT section as soon as possible before each meeting date, so that
arrangements can be made.

    Dated: July 30, 2012.
Timothy W. Manning,
Deputy Administrator, Protection and National Preparedness, Federal
Emergency Management Agency,Department of Homeland Security.
[FR Doc. 2012-19091 Filed 8-3-12; 8:45 am]
BILLING CODE 9110-21-P


[Federal Register Volume 79, Number 51 (Monday, March 17, 2014)]
[Proposed Rules]
[Pages 14633-14634]
[FR Doc No: 2014-05739]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1311]

Proposed Flood Hazard Determinations for Brown County, Texas, and
Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed notice; withdrawal.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is

withdrawing its proposed notice concerning proposed flood hazard
determinations, which may include the addition or modification of any
Base Flood Elevation, base flood depth, Special Flood Hazard Area
boundary or zone designation, or regulatory floodway on the Flood
Insurance Rate Maps, and where applicable, in the supporting Flood
Insurance Study reports for Brown County, Texas, and Incorporated
Areas.

DATES: This withdrawal is effective March 17, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1311, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 21, 2013, FEMA published a proposed
notice at 78 FR 29770, proposing flood hazard determinations in Brown
County, Texas. FEMA is withdrawing the proposed notice.

    Authority:  42 U.S.C. 4104; 44 CFR 67.4.

    Dated: January 31, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-05739 Filed 3-14-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Proposed Rules]
[Pages 32825-32826]
[FR Doc No: 2018-15145]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1990-0011; FRL-9980-63--Region 5]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the Beloit Corporation
Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; notification of intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 5 is issuing
a Notice of Intent to Delete the Former Beloit Corporation Research
Center Property (RCP) of the Beloit Corporation Superfund Site (Site),
in Rockton, Illinois, from the National Priorities List (NPL) and
requests public comments on this proposed action. This partial deletion
includes all media at the 20-acre RCP. The rest of the Site remains on
the NPL and is not affected by this action. The NPL, promulgated
pursuant to Section 105 of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) of 1980, as amended, is an
appendix of the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). EPA and the State of Illinois, through the
Illinois Environmental Protection Agency, have

determined that all appropriate response actions at the RCP identified
under CERCLA have been completed, other than maintenance, monitoring
and five-year reviews. However, this partial deletion does not preclude
future actions under CERCLA.

DATES: Comments must be received by August 15, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-1990-0011, by mail to Randolph Cano, NPL Deletion Coordinator,
U.S. Environmental Protection Agency Region 5 (SR-6J), 77 West Jackson
Boulevard, Chicago, IL 60604. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the Rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Randolph Cano, NPL Deletion
Coordinator, U.S. Environmental Protection Agency Region 5 (SR-6J), 77
West Jackson Boulevard, Chicago, IL 60604,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
today's Federal Register, we are publishing a direct final Notice of
Partial Deletion for the Former Beloit Corp. Research Center Property
of the Beloit Corp. Superfund Site without prior Notification of Intent
for Partial Deletion because EPA views this as a noncontroversial
revision and anticipates no adverse comment. We have explained our
reasons for this partial deletion in the preamble to the direct final
Notice of Partial Deletion, and those reasons are incorporated herein.
If we receive no adverse comment(s) on this partial deletion action, we
will not take further action on this Notification of Intent for Partial
Deletion. If we receive adverse comment(s), we will publish a timely
withdrawal of the direct final partial deletion in the Federal Register
informing the public that the partial deletion will not take effect. We
will then, as appropriate, address all public comments in a subsequent
final Notice of Partial Deletion based on this Notification of Intent
for Partial Deletion. We will not institute a second comment period on
this Notification of Intent for Partial Deletion. Any parties
interested in commenting must do so at this time.
    For additional information, see the direct final Notice of Partial
Deletion which is located in the Rules section of this Federal
Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

    Dated: June 25, 2018.
Cathy Stepp,
Regional Administrator, Region 5.
[FR Doc. 2018-15145 Filed 7-13-18; 8:45 am]
BILLING CODE 6560-50-P


Chapter 9
Title V Permit Fees
Comment 9.1-1: Commenter 0267 suggested that EPA exclude GHGs from fee calculations entirely because permitting costs are covered by existing fees. To date, there are a minimal number of GHG permit terms for incorporation in Title V permits. Facilities with GHG PSD permits may have terms included in a Title V permit, but all of the GHG Emission Reporting (40 CFR. Part 98) terms are excluded. In addition, there are no current GHG technology standards. Consequently, the somewhat limited costs associated with including GHG requirements in permit terms do not currently warrant any increased Title V permit fees. Given that GHG emissions are several orders of magnitude greater than emissions of traditional pollutants, there would be a disproportionate increase in fees relative to the actions necessary to incorporate and maintain Title V permits that include GHG terms. The fees would be burdensome, excessive, and unnecessary. The fundamental requirement is to collect fees sufficient to cover program costs. To the extent the EPA decides to finalize a GHG cost adjustment, it cannot be structured in a way to overstate the costs necessary to run the program.
Commenter 0267 stated the EPA should prepare an analysis of how various state and local agencies set their Title V permit fees to eliminate uncertainty as to whether the final rule will impact state permitting fees. As with the potential for PSD-related SIP changes and EPA approval, EPA should not finalize the proposal until the necessary SIP changes are in place.
Commenter 0267 stated that if EPA adopts option 1 (the activity-based adjustment option), the EPA should clarify how many activities can be associated with the processing of a single permit, recommending that the EPA set a maximum number of annual hours that can be used to set a fee under option 1. If the EPA does not clarify this, the option 1 approach would be unrealistic as to the actual costs of the program, which will lead to states conducting comprehensive demonstrations of program costs to justify lower fees than the presumptive minimum, nullifying the benefit of the presumptive fee calculation. Such an approach would be arbitrary and capricious because it would eliminate the streamlining effect of the presumptive fee approach.
Commenter 0267 said if option 1 is selected for the final rule, the allocation of fees would need to be "annualized," since most of the activities do not occur on an annual basis. Part 70.9(b)(2)(v) does not provide that the adjustment is "annual." If intended to be an annual fee, it is important that the basis of the calculated fee be clarified. The "activities" are not annually recurring activities, but rather periodic.
Response 9.1-1: The commenter supports the January 8, 2014 proposal to exempt GHGs from the emissions-based fee calculations of 40 CFR 70 and 71 and seems to support an alternative GHG cost adjustment if it is reasonable and based on actual costs, but does not directly support any of the proposed GHG adjustment options specifically. The final rule exempts GHGs from emissions-based calculations and finalizes GHG adjustment option 1, the adjustment based on recovering the costs to permitting authorities of conducting certain analyses to determine if GHGs are addressed appropriately in permit applications and permits. See the more detailed background discussion concerning title V fees in the preamble to the final rule and the separate response to comments (RTC) related to the new source requirements under section 111(b).
The commenter also expresses concern that the costs of GHG permitted are limited, citing the low number of GHG emissions standards and permit terms and the exclusion of the GHG Mandatory Reporting Rule. The EPA responds that the cost of GHG permitting that we discussed in the proposed and final preambles are not related to the source type, it's emissions, or the number of applicable requirements that apply to it, but rather, are related to the costs for permitting authorities to determine if GHGs are adequately addressed in the applications and permits, considering the novel nature of GHGs and the inexperience of permitting authorities with addressing them in the permitting context. The EPA based the costs of the GHG adjustments on analyses that it conducted with respect to the costs of implementing permit programs by state and local agencies, we discussed this information in the preamble for the proposed and final rules, and we have placed this information in the docket for this rulemaking. For more on this fee-related issue and the other issues raised in this section of the RTC, please see the preamble to the final rule and the separate the separate response to comments (RTC) related to the new source requirements under section 111(b).
The commenter asked the EPA to not finalize the proposal until after an analysis is conducted of how state agencies set their fees and after necessary SIP changes are in place. The EPA disagrees with the suggestion, as we do not believe such an analysis is required to be conducted or otherwise needed by the EPA prior to finalizing the GHG cost adjustments of the final part 70 rule. Also, the EPA does not believe we are required or need to wait until states revise their SIPs prior to finalizing the GHG adjustments of part 70. The EPA notes that changes to a state's operating permit program are not required to occur through a SIP revision and do not generally occur through a SIP revision. Certain states may need to revise their part 70 permit programs in response to the final rule but it is not necessary for the EPA to determine which states will need to do this prior to finalizing the revised fee rules. The implementation of the GHG adjustment for states that implement the presumptive minimum will be straightforward. A bigger concern for states would be cases where the revised cost formula would lead to the need to change the rules concerning fee payment by sources, but this is an area where the EPA has given states discretion and such considerations are beyond the scope of this rulemaking action.
The commenter asked that if we finalize GHG adjustment option 1, we clarify how many activities are associated with the processing of a single permit and that we set a maximum number of hours that can be used to set a fee to avoid overestimation of costs. The EPA responds that we have made certain clarifications with respect to the wording of the activities under the option 1 approach of the final rule that should address many of the concerns of the commenter. The EPA is finalizing the list of activities used to calculate the GHG adjustment to include a minor regulatory revision and we make certain clarifications in the preamble to the final rule to ensure consistent implementation of the activities. For example, for the first activity, "GHG completeness determination (for initial permit or updated application)," we clarify that the cost for this activity is a one-time charge that covers the review of the initial application and any supplements or updates. Thus, any updates to an initial application are included in a single "GHG completeness determination," rather than as a separate activity for which the source would be charged in addition to the completeness determination for the initial application.
The commenter suggested that revising the presumptive minimum approach through the final rule might be unlawful because it would cause states to have to switch from the presumptive minimum approach to the detailed accounting approach of part 70. As described above, we disagree that the option 1 approach of the final rule would lead to overestimation of costs. On the second part of the argument, CAA section 502(b)(3) and 40 CFR 70.9(a) requires states to charge fees that are sufficient to cover the permit program costs and the EPA has determined that the revised fee provisions (which includes GHG adjustment option 1) will ensure that the presumptive minimum approach will continue to meet the statutory requirements for program funding. A state that wishes to charge less than the presumptive minimum amount be are finalizing would be required to switch to the detailed accounting approach based on a demonstration "that collecting an amount less than the [presumptive minimum amount] will" result on funds sufficient to cover the program costs. Such a switch would be consistent with CAA section 503(b)(3)(B)(iv) and 40 CFR 70.9(b)(5).
The commenter also asked that if an activity-based approach is used that it be imposed annually, rather than periodically. The preamble to the final rule and the final rule clearly provide that the GHG adjustment would be an annual adjustment. The GHG adjustment would be added to the presumptive minimum calculation performed by the state for part 70 purposes, which is an annual calculation of the state's minimum fee revenue target. See 40 CFR 70.9(b)(2)(i).


[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34747-34748]
[FR Doc No: 2022-12164]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2022-0033]

Qualification of Drivers; Exemption Applications; Hearing

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 14 individuals from the
hearing requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. The exemptions enable these hard of hearing and deaf
individuals to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on June 3, 2022. The exemptions
expire on June 3, 2024.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
DOT, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-
0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through
Friday, except Federal holidays. If you have questions regarding
viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2022-0033, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption request. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.

II. Background

    On April 1, 2022, FMCSA published a notice announcing receipt of
applications from 14 individuals requesting an exemption from the
hearing requirement in 49 CFR 391.41(b)(11) to operate a CMV in
interstate commerce and requested comments from the public (87 FR
19173). The public comment period ended on May 2, 2022, and no comments
were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these

individuals would achieve a level of safety equivalent to, or greater
than, the level that would be achieved by complying with Sec.
391.41(b)(11).
    The physical qualification standard for drivers regarding hearing
found in Sec.  391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, 35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 3, 1971).

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on current medical information and literature, and the 2008
Evidence Report, ``Executive Summary on Hearing, Vestibular Function
and Commercial Motor Driving Safety.'' The evidence report reached two
conclusions regarding the matter of hearing loss and CMV driver safety:
(1) no studies that examined the relationship between hearing loss and
crash risk exclusively among CMV drivers were identified; and (2)
evidence from studies of the private driver's license holder population
does not support the contention that individuals with hearing
impairment are at an increased risk for a crash. In addition, the
Agency reviewed each applicant's driving record found in the Commercial
Driver's License Information System, for commercial driver's license
(CDL) holders, and inspections recorded in the Motor Carrier Management
Information System. For non-CDL holders, the Agency reviewed the
driving records from the State Driver's Licensing Agency. Each
applicant's record demonstrated a safe driving history. Based on an
individual assessment of each applicant that focused on whether an
equal or greater level of safety is likely to be achieved by permitting
each of these drivers to drive in interstate commerce as opposed to
restricting him or her to driving in intrastate commerce, the Agency
believes the drivers granted this exemption have demonstrated that they
do not pose a risk to public safety.
    Consequently, FMCSA finds that in each case exempting these
applicants from the hearing standard in Sec.  391.41(b)(11) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
each driver must report any crashes or accidents as defined in Sec.
390.5; (2) each driver must report all citations and convictions for
disqualifying offenses under 49 CFR 383 and 49 CFR 391 to FMCSA; and
(3) each driver is prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 14 exemption applications, FMCSA
exempts the following drivers from the hearing standard, Sec.
391.41(b)(11), subject to the requirements cited above:

Ryheem Brown (TX)
Kevin Cooley (MT)
Adrian Cortez (NM)
Michael Cover (MI)
Gregory Crane (AZ)
Stephen Daniels (KS)
Daniel Darnall (NE)
Adam Day (FL)
Michael Derenick (PA)
Gabriel Garza (TX)
Scott Gentry (FL)
Rod Lagasse (NY)
Robert Rollins (NC)
John Statler (CO)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2022-12164 Filed 6-6-22; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7292-7293]
[FR Doc No: 2018-03360]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2018-0008-N-2]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces that FRA is forwarding the Information Collection Request
(ICR) abstracted below to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the information collection and
its expected burden. On December 11, 2017, FRA published a notice
providing a 60-day period for public comment on the ICR.

DATES: Interested persons are invited to submit comments on or before
March 22, 2018.

ADDRESSES: Submit written comments on the ICR to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention: FRA Desk Officer.
Comments may also be sent via email to OMB at the following address:
[email protected].

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Safety
Regulatory Analysis Division, RRS-21, Federal Railroad Administration,
1200 New Jersey Avenue SE, Mail Stop 25, Washington, DC 20590
(telephone:<PHONE_NUMBER>); or Ms. Kim Toone, Information Collection
Clearance Officer, Office of Administration, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Avenue SE, Mail Stop 35, Washington, DC 20590 (telephone: (202) 493-
6132).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8-12. On December 11, 2017, FRA published a 60-
day notice in the Federal Register soliciting comment on the ICR for
which it is now seeking OMB approval. See 82 FR 58265. FRA received one
comment in response to this notice.
    On January 24, 2018, Dennis J. Fixler, the Chief Economist of the
Bureau of Economic Analysis (BEA), sent an electronic letter expressing
BEA's strong support of the continued collection of data by FRA on the
Accident/Incident Reporting and Recordkeeping forms. He noted that the
data collected on these forms are crucial to key components of BEA's
economic statistics. In his letter, Dr. Fixler stated that BEA uses
data collected on these forms to prepare estimates of the employee
compensation component of national income and state personal income.
Specifically, Dr. Fixler stated that data on the number of employee
injuries and deaths from forms FRA F6180.55 and FRA F 6180.55a,
Railroad Injury and Illness Summary, are used to prepare estimates of
workers' compensation for the railroad industry, and that these same
data are used to prepare estimates of workers' compensation for the
railroad industry by State.
    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. Federal law
requires OMB to approve or disapprove paperwork packages between 30 and
60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5
CFR 1320.12(d); see also 60 FR 44978, 44983, Aug. 29, 1995. OMB
believes the 30-day notice informs the regulated community to file
relevant comments and affords the agency adequate time to digest public
comments before it renders a decision. 60 FR 44983, Aug. 29, 1995.
Therefore, respondents should submit their respective comments to OMB
within 30 days of publication to best ensure having their full effect.
    Comments are specifically invited on the following ICR regarding:
(1) Whether the information collection activities are necessary for FRA
to properly execute its functions, including whether the information
will have practical utility; (2) the accuracy of FRA's estimates of the
burden of the information collection activities, including the validity
of the methodology and assumptions used to determine the estimates; (3)
ways for FRA to enhance the quality, utility, and clarity of the
information being collected; and (4) ways to minimize the burden of
information collection activities on the public, including the use of
automated collection techniques or other forms of information
technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance:
    Title: Accident/Incident Reporting and Recordkeeping.
    OMB Control Number: 2130-0500.
    Abstract: The collection of information is due to the railroad
accident reporting regulations in 49 CFR part 225 that require
railroads to submit monthly reports summarizing collisions,
derailments, and certain other accidents/incidents involving damages
above a periodically revised dollar threshold, as well as certain
injuries to passengers, employees, and other persons on railroad
property. Because the reporting requirements and the information needed
regarding each category of accident/incident are unique, a different
form is used for each category.
    FRA hereby informs the regulated community of railroads and the
general public that it is revising the instructions for Form FRA F
6180.57, Highway-Rail Grade Crossing Accident/Incident Report, to
capture information concerning post-accident toxicological testing for
certain human factor highway-rail grade crossing accidents and
incidents in the narrative block of this form. The newly revised 49
Code of Federal Regulations (CFR) 219.201(a), effective on June 12,
2017, requires post-accident toxicological testing of railroad
employees under various, enumerated

circumstances, and include certain human-factor categories of highway-
rail grade crossing accidents and incidents (49 CFR 219.201(a)(5)). See
81 FR 37894 (June 10, 2016).
    FRA will begin the process to add a block to Form FRA F 6180.57 to
accommodate this requirement. In the interim, if railroads perform drug
and alcohol testing on any employee or employees involved in a highway-
rail grade crossing accident, FRA is requesting the railroad place the
drug and alcohol coding information in Item No. 54, ``Narrative
Description'', of Form FRA F 6180.57.
    In accordance with the requirements of the PRA, on February 28,
2017, FRA transmitted to OMB its renewal submission for this collection
of information. This submission increased the agency estimate of the
annual number of forms completed for Form FRA F 6180.57 by 160 forms
from the previously approved submission to OMB (from a total of 2,000
to 2,160 forms). FRA estimated two hours as the average burden time to
complete Form FRA F 6180.57, including the time for the information to
be placed in the narrative block of the form. OMB cleared this renewal
submission approving a total burden of 46,577 hours and 109,440
responses on June 2, 2017, and extended the previous clearance for
another three years. The new expiration date for this information
collection is now June 30, 2020. FRA now seeks approval for this change
to the Form 57 instructions.
    Type of Request: Extension with change of a current information
collection.
    Affected Public: Businesses.
    Form(s): FRA F 6180.39i; 54; 55; 55A; 56; 57; 78; 81; 97; 98; 99;
107; 150.
    Respondent Universe: 744 railroads.
    Frequency of Submission: On occasion.
    Total Estimated Annual Responses: 109,440.
    Total Estimated Annual Burden: 46,577 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to a collection of
information, unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Brett A. Jortland,
Acting Deputy Chief Counsel.
[FR Doc. 2018-03360 Filed 2-16-18; 8:45 am]
 BILLING CODE 4910-06-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:	  	01/06/2009

Subject:		Chlorimuron-Ethyl.  Petition for Tolerances on Cranberry,
Bearberry, Bilberry, Lowbush Blueberry, Cloudberry, Lingonberry,
Muntries and Partridgeberry (Lowgrowing Berry Subgroup 13-07H, Except
Strawberry).  Summary of Analytical Chemistry and Residue Data.

PC Code:  128901	DP Barcodes:  D335807, 346842

Decision Nos.:  372736	Registration No.:  352-436

Petition Nos.:  6E7153	Regulatory Action:  Section 3

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:  90982-32-4

MRID Nos.:  47004901, 43483707 	40 CFR:  180.429

FROM:	Anant Parmar, Biologist  	  SEQ CHAPTER \h \r 1

		Registration Action Branch II

		Health Effects Division (7509P)

THROUGH:	Michael A. Doherty, Ph.D., Chemist

		Richard Loranger, Ph.D., Senior Scientist

	Registration Action Branch II

		Health Effects Division (7509P)  SEQ CHAPTER \h \r 1

TO:		Daniel Rosenblatt/Sidney Jackson/Barbara Madden, RIMUERB

		Registration Division (7505P)

This document was originally prepared under contract by Dynamac
Corporation (1910 Sedwick Road, Building 100, Suite B, Durham, NC 27713;
submitted 1/07/2008).  The document has been reviewed by the Health
Effects Division (HED) and revised to reflect current Office of
Pesticide Programs (OPP) policies.

Executive Summary

Chlorimuron-ethyl [ethyl
2-(4-chloro-6-methoxypyrimidin-2-ylcarbamoylsulfamoyl)

benzoate] is a sulfonylurea herbicide registered for use on peanuts and
soybeans in the U.S. for  the postemergence control of broadleaf weeds
and yellow nutsedge.  Chlorimuron-ethyl is formulated as a
water-dispersible granular formulation (WDG) at concentrations ranging
from 8.3-31.8% a.i., with end-use products registered to FMC Corporation
(2 products), E.I. du Pont de Nemours and Co. (DuPont; 12 products), and
Valent U.S.A. Corporation (2 products).

In the current petition, Interregional Research Project No. 4 (IR-4) is
proposing use of a 25% WDG formulation of chlorimuron-ethyl (DuPont
Classic® Herbicide; EPA Reg. No. 352-436) on members of the low-growing
berry subgroup (13-07H) for postemergence control of various broadleaf
weeds and yellow nutsedge.  The proposed use is for a single broadcast
foliar application at up to 0.0156 lb ai/A during fruit development.
Applications can be made using only ground equipment in a minimum of 15
gal/A, and the directions allow for the use of a non-ionic surfactant
(NIS) as a adjuvant at up to 0.25% of the spray volume.  The proposed
preharvest interval (PHI) is 60 days.  In conjunction with this use,
IR-4 is proposing permanent tolerances for chlorimuron-ethyl on the
following members of the low-growing berry subgroup, except strawberry
(subgroup 13-07H):

Bearberry	0.02 ppm

Bilberry	0.02 ppm

Blueberry, lowbush	0.02 ppm

Cloudberry	0.02 ppm

Cranberry	0.02 ppm

Lingonberry	0.02 ppm

Muntries	0.02 ppm

Partridgeberry	0.02 ppm

Tolerances have been established for residues of chlorimuron-ethyl in/on
peanuts and soybeans at 0.02 ppm and 0.05 ppm, respectively [40 CFR
§180.429].  The nature of chlorimuron-ethyl residues in plants is
adequately understood for purposes of this petition.  Studies are
available on peanuts, soybeans, and corn.  For peanuts, the data
indicated a lack of significant translocation of the active ingredient
in nutmeats or hulls.  For soybeans, only parent chlorimuron-ethyl was
observed.  For corn, the data indicated a lack of significant
translocation of the active ingredient in grain.  Based on these
findings and the status of the requested commodities as minor crops, the
requirement for an additional metabolism study on a fruit crop is being
waived for purposes of this petition.  The residue of concern is
chlorimuron-ethyl per se.

As the crop uses being proposed in this petition do not include any
regulated livestock feedstuffs, issues pertaining to livestock
metabolism, analytical methods and storage stability data for animal
commodities, and residues in livestock commodities are not relevant to
the current petition.

Adequate HPLC methods are available for enforcing the current tolerances
on soybeans and peanuts; however, these methods have not been validated
using crop matrices similar to berries.  Typically, an independent
laboratory validation (ILV) trial should be conducted to determine if
either of these methods is adequate for enforcing the proposed
tolerances.  In lieu of the cranberry ILV, IR-4 has now submitted
sufficient information for HED to conclude that the rice analytical
method is a viable surrogate for the cranberry ILV trial.  The HPLC
method used in the cranberry field trial is adequate for enforcing the
proposed tolerance on berries of the low-growing berries subgroup,
except strawberry (subgroup 13-07H).

An adequate HPLC/photoconductivity method was used for collecting data
on residues of chlorimuron-ethyl in/on cranberry samples.  For this
method, residues were extracted with 0.1 M aqueous phosphate buffer,
adjusted to pH 5, and cleaned up by elution through C18 extraction disc
and partitioning into dichloromethane.  Residues were then determined by
normal-phase HPLC using a silica column with an isocratic mobile phase
and a photoconductivity detector.  The statistically calculated limits
of quantitation and detection (LOQ and LOD) were 0.0084 and 0.0028 ppm,
respectively.  The lowest level of method validation (LLMV) was 0.020
ppm.

Frozen storage stability data for chlorimuron-ethyl in cranberries at
-20°C were submitted along with the cranberry field trial data.  These
data indicate that chlorimuron-ethyl declined by 34% in cranberries over
24.5 months of frozen storage (↓1.39% per month).  However, the
storage stability data are not fully acceptable as no 0-day analysis was
conducted on the fortified samples prior to storage.  For purposes of
this petition, HED will use the available data to correct the cranberry
residue data for potential declines of 1.39% per month during frozen
storage.

Adequate field trial data are available supporting the proposed use on
cranberry, which is the representative crop for the low-growing berry
subgroup, except strawberry.  Following a single broadcast foliar
application of chlorimuron-ethyl (WDG) at 1x the proposed rate,
uncorrected residues chlorimuron-ethyl were non-detectable (<0.0028 ppm)
in/on all samples of cranberries harvested at 57-63 days after treatment
(DAT).  Even if residue values are corrected to account for a potential
37% decline during frozen storage, the resulting residues (<0.0044 ppm)
are below the LOQ as well as the validated method LLMV (0.02 ppm), which
is also the proposed tolerance.

As there are no regulated processed commodities associated with this
crop subgroup, no processing data are required for this petition.  In
addition, no data pertaining to rotational crops are required for this
petition as members of this crop subgroup are not rotated.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry
Deficiencies

Deficiencies were noted in the submitted data pertaining to plant
metabolism, enforcement analytical methods, and storage stability (see
below).  However, sufficient data are available to allow for the
establishment of permanent tolerances for chlorimuron-ethyl on
low-growing berries, except strawberry.

	•	Plant metabolism studies have only been conducted on soybeans,
peanuts, and corn which are not similar to the proposed use on
low-growing berries.  Typically, a new metabolism study would be
required; however, as the proposed uses are for minor crops and residues
are expected to be low (<LOQ), no additional plant metabolism data are
required for this petition.  The residue of concern is chlorimuron-ethyl
per se.

	•	Adequate HPLC methods are available for enforcing the current
tolerances on soybeans and peanuts; however, these methods have not been
validated using crop matrices similar to berries.  Typically, an
independent laboratory validation (ILV) trial should be conducted to
determine if either of these methods is adequate for enforcing the
proposed tolerances.  In lieu of the cranberry ILV, IR-4 has now
submitted sufficient information for HED to conclude that the rice
analytical method is a viable surrogate for the cranberry ILV trial.
The HPLC method used in the cranberry field trials is adequate for
enforcing the proposed tolerance on berries of the low-growing berries
subgroup, except strawberry (subgroup 13-07H).

	•	The submitted storage stability data are not fully acceptable as no
0-day analysis was conducted on the fortified sample prior to frozen
storage.  However, for purposes of this petition, HED will use the
available data to correct the cranberry residue data for potential
declines of 1.39% per month during frozen storage.

	•	The petitioner should provide confirmatory data for the corn
metabolism study verifying that the majority of the immature samples
were initially analyzed within ~6 months of harvest.  This information
may be provided in a future tolerance petition.

HED recommends for establishing a permanent tolerance for residues of
chlorimuron-ethyl at 0.02 ppm in/on Berry, lowgrowing, subgroup 13-07H,
except strawberry.  A separate tolerance for each member of the subgroup
is not necessary as the proposed revisions to the berry crop group have
been finalized (72 FR 69150, 12/7/2007).  A human health risk assessment
for chlorimuron-ethyl is forthcoming.

Background

Chlorimuron-ethyl is a sulfonylurea herbicide registered for use on
peanuts and soybeans in the U.S. for the postemergence control of
broadleaf weeds and yellow nutsedge.  It is formulated as a WDG at
8.3-31.8% ai.  For peanuts, chlorimuron-ethyl may be applied as a
postemergence broadcast, banded or low volume application at up to
0.0117 lb ai/A/season.  For soybeans, chlorimuron-ethyl may be applied
early-preplant, preplant, postplant, preemergence, postemergence, or
postharvest as either a broadcast, banded or low volume application at
up to 0.01172-0.0803 lb ai/A/season.  The PHIs are 45 days for peanuts
and 60 days for soybean.

IR-4 has submitted a petition (PP#6E7153) supporting the use of
chlorimuron-ethyl on low-growing berries, except strawberry (subgroup
13-07H), for the postemergence control of various broadleaf weeds and
yellow nutsedge.  The nomenclature and physicochemical properties of
chlorimuron-ethyl are presented below in Tables 1 and 2.

Table 1.	Chlorimuron-Ethyl Nomenclature.

Compound

Common name	Chlorimuron-ethyl

Company experimental name	DPX-F6025

IUPAC name	ethyl 2-(4-chloro-6-methoxypyrimidin-2- ylcarbamoylsulfamoyl)
benzoate

CAS name	ethyl
2-[[[[(4-chloro-6-methoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]
benzoate

CAS registry number	90982-32-4

End-use product (EP)	25% WDG; DuPont CLASSIC® Herbicide (EPA Reg. No.
352-436)

Table 2.	Physicochemical Properties of Chlorimuron-Ethyl.

Parameter	Value	Reference

Melting point/range	181°C	PP#3G2959; 1/10/84; S. Creeger

pH	4.4

	Density	1.51 g/ml

	Water solubility (mg/L)	pH 1.3 = 1.5

pH 1.9 = 1.5

pH 2.5 = 1.5

pH 4.2 = 4.1

pH 5.0 = 9.0

pH 5.8 = 99

pH 6.5 = 450

pH 7.0 = 1200

	Solvent solubility (mg/100 mL at 25°C)	Acetone = 7.05

Acetonitrile = 3.10

Benzene = 0.815

Ethyl Acetate = 2.36

Ethyl Alcohol = 0.392

n-Hexane = 0.006

Methyl Alcohol = 0.740

Methylene Chloride = 15.3

Xylene = 0.283

	Vapor pressure (25°C)	1.5 x 10-5 mm Hg

	Dissociation constant, pKa (25°C)	4.2

	Octanol/water partition coefficient, Log(KOW)	1.3

	UV/visible absorption spectrum	Not available

860.1200  Directions for Use

There are currently 16 end-use products containing chlorimuron-ethyl
registered in the U.S.  These products are all WDG formulations
containing 8.3-31.8% of chlorimuron-ethyl.  Two products are registered
to FMC Corporation, 12 products are registered to DuPont, and 2 products
are registered to Valent U.S.A. Corporation.

IR-4 is proposing use of a 25% WDG formulation of chlorimuron-ethyl
(Classic® Herbicide; EPA Reg. No. 352-436) on members of the
low-growing berry subgroup (13-07H) for postemergence control of various
broadleaf weeds and yellow nutsedge.  This formulation is currently
registered to DuPont for use on soybeans, peanuts and noncrop areas.  An
example supplemental label for this formulation was provided, and the
proposed use directions are summarized below in Table 3.

Table 3.	Summary of Proposed Directions for Use of Chlorimuron-Ethyl.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations

Low-growing Berry Subgroup 13-07H, except Strawberry

(including cranberry, bearberry, bilberry, lowbush blueberry,
cloudberry, ligonberry muntries and partridgeberry)

Broadcast foliar application during late spring after bloom; Ground
equipment only	25% WDG

[352-436]	0.0156	1	0.0156	60	Include a non-ionic surfactant at 0.25%.

Apply in a minimum of 15 gal/A

Conclusions.  The proposed use directions are adequate and are supported
by available field trial data.

860.1300 Nature of the Residue - Plants

DP# 301317, R. Griffin, 8/31/2004

DER Reference:	43483707.der.doc (Corn)

IR-4 submitted a corn metabolism study with the current petition.  The
most recent risk assessment summarized soybean and peanut metabolism
studies (D301317, R. Griffin, 8/31/2004).  Studies on soybean and peanut
were previously determined to be acceptable.

In the corn metabolism study, corn (maize) was treated with
[14C-phenyl]chlorimuron-ethyl and [14C-pyrimidine]chlorimuron-ethyl at a
target rate of 0.315 lb ai/A (5 oz ai/A).  Two treatment regimes were
established, reflecting a single preemergence application (soil surface
spray after planting) or postemergence application (foliar broadcast
spray to plants at the 3-leaf growth stage) to greenhouse-grown corn.

Corn plants were harvested 28, 44, 89, and 196 days after preemergence
treatment and 0, 10, 20, 41, and 164 days after postemergence treatment;
samples of mature plants (196-day and 164-day samples) were separated
into grain and mature forage (shoots, leaves, husks, and cob after
removal of grain).

Total radioactive residues (TRR) were similar between the two labels for
each treatment type.  Overall, TRR were low in grain ((0.01 ppm) and
mature forage ((0.09 ppm), and higher in immature plants.  As expected,
higher TRR were observed in immature plants following postemergence
treatment ((61.1 ppm); whereas as the highest TRR observed in immature
plants following preemergence treatment was ((0.489 ppm).  Results of
the corn metabolism study are summarized in Tables 4, 5, 6, and 7.

TABLE 4.	Summary of Characterization and Identification of Radioactive
Residues in Corn Matrices Following Preemergence Application of
[14C-phenyl]Chlorimuron-ethyl at 0.315 lb ai/A.

Metabolite Fraction	Immature Plant

(28 DAT)	Immature Plant

(44 DAT)	Immature Plant

(89 DAT)	Mature Forage

(196 DAT)

	TRR = 0.461 ppm	TRR = 0.219 ppm	TRR = 0.439 ppm	TRR = 0.090 ppm

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

IN-B4450	33.3	0.153	25.5	0.056	6.9	0.03	1.4	0.001

Conjugated IN-B4450	--	--	--	--	45.4	0.198	--	--

IN-L9130	3.6	0.016	2.2	0.005	4.5	0.019	--	--

Unidentified metabolites	20.2	0.093	6.8	0.015	2.3	0.01	--	--

Polar metabolites	39.1	0.18	42.0	0.091	15.9	0.070	55.3	0.05

Acid hydrolysate; aqueous soluble	--	--	--	--	15.6	0.069	--	--

ACN/water extract	--	--	17	0.037	--	--	--	--

EDTA	--	--	--	--	--	--	7.2	0.006

Methanol reflux	--	--	--	--	--	--	8.9	0.008

0.1 M NaOH	--	--	--	--	--	--	8.2	0.007

0.1 M HCl	--	--	--	--	--	--	2.5	0.002

0.1 M HCl reflux	--	--	--	--	--	--	7.2	0.006

Total identified	36.9	0.169	27.7	0.061	56.8	0.247	1.4	0.001

Total characterized	59.3	0.273	65.8	0.143	33.8	0.149	89.3	0.079

Total extractable	98	0.451	96	0.209	93	0.406	91	0.081

Unextractable (PES)1	2	0.010	5	0.010	7	0.033	6.3	0.006

Accountability2	100	100	100	97

TABLE 5.	Summary of Characterization and Identification of Radioactive
Residues in Corn Matrices Following Preemergence Application of
[14C-pyrimidine]Chlorimuron-ethyl at 0.315 lb ai/A.

Metabolite Fraction	Immature Plant

(28 DAT)	Immature Plant

(44 DAT)	Immature Plant

(89 DAT)	Mature Forage

(196 DAT)

	TRR = 0.489 ppm	TRR = 0.311 ppm	TRR = 0.400 ppm	TRR = 0.078 ppm

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

IN-N6186	11.1	0.054	10.4	0.032	5.2	0.021	2.1	0.002

Conjugated IN-N6186	--	--	--	--	24.6	0.098	--	--

IN-L9130	5.5	0.027	0.9	0.003	3.7	0.015	--	--

Unidentified metabolites	23.1	0.113	2.6	0.008	8.3	0.033	--	--

Polar metabolites	54.6	0.266	51.9	0.162	14.4	0.058	46.4	0.036

Acid hydrolysate; aqueous soluble	--	--	--	--	28.6	0.114	--	--

ACN/water extract	--	--	18	0.055	--	--	--	--

EDTA	--	--	--	--	--	--	3.6	0.003

Methanol reflux	--	--	--	--	--	--	7.4	0.006

0.1 M NaOH	--	--	--	--	--	--	3.1	0.002

0.1 M HCl	--	--	--	--	--	--	1.6	0.001

0.1 M HCl reflux	--	--	--	--	--	--	9.2	0.007

Total identified	16.6	0.081	11.3	0.035	33.5	0.134	2.1	0.002

Total characterized	77.7	0.379	72.5	0.225	51.3	0.205	71.3	0.055

Total extractable	96	0.468	91	0.283	90	0.360	75.9	0.059

Unextractable (PES)1	4	0.021	9	0.028	10	0.040	14.4	0.011

Accountability2	100	100	100	90

TABLE 6.	Summary of Characterization and Identification of Radioactive
Residues in Corn Matrices Following Postemergence Application of
[14C-phenyl]Chlorimuron-ethyl at 0.311 lb ai/A.

Metabolite Fraction	Immature Plant

(0 DAT)	Immature Plant

(10 DAT)	Immature Plant

(20 DAT)	Immature Plant

(41 DAT)

	TRR = 59.3 ppm	TRR = 50.8 ppm	TRR = 35.0 ppm	TRR = 36.0 ppm

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

Chlorimuron-ethyl	88.2	52.29	91.4	46.73	90.4	31.58	77.8	28.09

IN-B4450	--	--	6.0	3.03	3.4	1.19	3.5	1.25

IN-L9130	--	--	--	--	--	--	1.8	0.64

Unidentified metabolites	9.3	5.5	--	--	5.2	1.82	6.3	2.27

Polar metabolites	--	--	0.6	0.37	--	--	8.5	3.07

Total identified	88.2	52.29	97.4	49.76	93.8	32.77	83.1	29.98

Total characterized	9.3	5.5	0.6	0.37	5.2	1.82	14.8	5.34

Total extractable	99.8	59.2	99.6	50.6	99	34.6	98	35.4

Unextractable (PES)1	0.2	0.12	0.4	0.18	1	0.47	2	0.64

Accountability2	100	100	100	100

TABLE 7.	Summary of Characterization and Identification of Radioactive
Residues in Corn Matrices Following Postemergence Application of
[14C-pyrimidine]Chlorimuron-ethyl at 0.315 lb ai/A.

Metabolite Fraction	Immature Plant

(0 DAT)	Immature Plant

(10 DAT)	Immature Plant

(20 DAT)	Immature Plant

(41 DAT)

	TRR = 43.4 ppm	TRR = 61.1 ppm	TRR = 23.5 ppm	TRR = 19.4 ppm

	%TRR	ppm	%TRR	ppm	%TRR	ppm	%TRR	ppm

Chlorimuron-ethyl	88.0	38.21	89.4	54.35	66.6	15.62	75.3	14.58

IN-N6186	--	--	6.9	4.18	9.8	2.30	2.7	0.53

IN-L9130	--	--	1.0	1.6	--	--	--	--

Unidentified metabolites	10.3	4.48	0.2	0.12	7.0	1.63	6.2	1.2

Polar metabolites	--	--	0.9	0.53	7.6	1.79	9.9	1.93

Total identified	88.0	38.21	97.3	60.13	76.4	17.92	78.0	15.11

Total characterized	10.3	4.48	1.1	0.65	14.6	3.42	16.1	3.13

Total extractable	99.7	43.3	99.3	60.7	99	23.2	95	18.4

Unextractable (PES)1	0.3	0.12	0.7	0.42	1	0.31	5	0.97

Accountability2	100	100	100	100

0.007 ppm) from grain and in mature forage treated postemergence,
extraction with ACN/water released 56-92% TRR (~0.01 ppm);
nonextractable residues for these matrices were ≤0.008 ppm.  The
extraction and hydrolysis procedures adequately extracted the majority
of residues from corn matrices.  Because extraction results were
normalized for immature corn plants, accountabilities were 100%;
accountabilities for mature forage treated preemergence, reflecting
additional hydrolysis procedures, were ~90-97%.

Sample extraction and analysis dates were not provided; however, based
on the harvest and experimental end dates, immature plant samples may
have been stored frozen for up to 7.6 months, and mature grain and
forage samples may have been stored for up to 2.1 months prior to
completion of analysis.  The metabolite profile in immature plants was
similar by treatment for both labels across the various sampling
interval.  Provided the petitioner submits the dates of sample
extraction and analysis to confirm that the majority of the immature
samples were initially analyzed within ~6 months of harvest, no
supporting storage stability data are required for the study.

Approximately 11-57% TRR was identified in immature plants treated
preemergence, and 76-97% TRR was identified in immature plants treated
postemergence.  In mature forage treated preemergence, 1-2% TRR was
identified.  The metabolite profiles were similar for the two labels by
treatment, except that a different cleavage product was observed for
each label:  IN-B4450 (sulfonamide) for the phenyl label and IN-N6186
(pyrimidine amide) for the pyrimidine label.

Residues were quantified by HPLC and/or TLC; HPLC quantification data
were summarized by the petitioner.  The petitioner reported that
identification of metabolites was confirmed by HPLC and TLC
co-chromatography with reference standards; however, representative
chromatograms reflecting co-chromatography were not provided.

Chlorimuron-ethyl was not detected in immature plants or mature forage
treated preemergence, but was the major identified residue in immature
plants (both labels) treated postemergence, at 88% TRR in 0-DAT samples,
89-91% TRR in 10-DAT samples, 67-90% TRR in 20-DAT samples, and 75-78%
TRR in 41-DAT samples.  The metabolite 4-hydroxy-chlorimuron-ethyl
(IN-L9130) was identified as a minor residue in immature plants treated
preemergence (28, 44, and 89 DAT; <6% TRR) and postemergence (10 and 41
DAT, <2% TRR).

The cleavage products IN-B4450 and IN-N6186 were both significant
metabolites.  Following application of phenyl-labeled chlorimuron-ethyl,
IN-B4450 was a major residue in preemergence 28- and 44-DAT immature
plants (33.3% and 25.5% TRR, respectively), and a minor residue in
preemergence 89-DAT immature plants (6.9% TRR) and mature forage (1.4%
TRR); in postemergence 10-, 20-, and 41-DAT immature plants, residues
were 3.4-6% TRR.  In addition, conjugated IN-B4450 (released with acid
hydrolysis) accounted for 45.4% TRR in preemergence 89-DAT immature
plants.  Following application of pyrimidine-labeled chlorimuron-ethyl,
IN-N6186 was a major residue in preemergence 28- and 44-DAT immature
plants (11.1% and 10.4% TRR, respectively), and a minor residue in
preemergence 89-DAT immature plants (5.2% TRR) and mature forage (2.1%
TRR); in postemergence 10-, 20-, and 41-DAT immature plants, residues
were 2.7-9.8% TRR.  Conjugated IN-N6186 (released with acid hydrolysis)
accounted for 24.6% TRR in preemergence 89-DAT immature plants.

Based on the corn metabolism study, the petitioner concluded that the
overall metabolic pathway involves cleavage of the sulfonylurea linkage
to yield the corresponding sulfonamide and pyrimidine amine, and
hydroxylation of the parent to yield 4-hydroxy-chlorimuron-ethyl.  The
fate of chlorimuron-ethyl was consistent in both pre- and postemergence
treatments.  The petitioner stated that the study results were similar
to those of the peanut and soybean metabolism studies which were
previously reviewed (PP#8F3694; DEB# 4691, 2/7/89, H. Fonouni; and
PP#5F3186; 12/16/85, C. Deyrup).

The proposed metabolic pathway for chlorimuron-ethyl in corn is
presented in Figure 1, which was copied without alteration from MRID
43483707.

FIGURE 1. 	Proposed Metabolic Profile of Chlorimuron-ethyl in Corn.

The most recent risk assessment summarized soybean and peanut metabolism
studies ((D301317, R. Griffin, 8/31/2004).  These studies included tests
in which [14C phenyl]chlorimuron-ethyl or
[14C-pyrimidine-2]chlorimuron-ethyl was applied to soybean and peanut.
Studies on soybean and peanut were previously determined to be
acceptable.

Soybean plants in the first to third trifoliate leaf stage were sprayed
with [14C-phenyl] or [14C-pyrimidine-2]chlorimuron-ethyl at a rate of
0.031 lbs ai/A (2x rate).  Plants were sampled on 0, 19, and 35 DAT and
mature beans were harvested at 103 DAT.  Only parent compound
chlorimuron-ethyl was observed in the plant wash (94-100%).  Growth
chamber studies were also submitted in which cut soybean plants were
immersed in solutions of [14C]chlorimuron-ethyl for several hours to 2
days.  These studies resulted in the identification of the following
metabolites: chlorimuron-ethyl homoglutathione conjugate,
chlorimuron-ethyl acid, pyrimidine amine, desmethyl pyrimidine amine,
and saccharin.  Considering the low level of residues in/on mature
soybeans expected from the use on soybeans (6-7 metabolites equivalent
to a total of <0.02 ppm chlorimuron-ethyl), HED did not require further
work to identify the metabolites comprising the terminal radioactive
residues.

In a greenhouse metabolism study, peanuts were treated with [14C-phenyl]
and [2-14C-pyrimidine]chlorimuron-ethyl at 0.031 lb ai/A (4x rate), 60
days prior to harvest.  The data indicated a lack of significant
translocation of the active ingredient.  Less than 1% of the total
radioactive residues (extractable and unextractable) were found in
either nutmeats or hulls, and over 99% of the radioactivity was present
in vines at harvest.  The total radioactive residues were found to be
about 0.02 and 0.05 ppm in nutmeat and hulls, respectively.  The
extractable residues in nut meats are between 51-63% whereas those in
the corresponding hulls are 54-75%.  The identified metabolites
constitute <15-28% and 29-33% of the total radioactive residues in
peanut nutmeats and hulls, respectively.  The residue of concern in both
soybeans and peanuts is chlorimuron-ethyl per se.

Conclusions.  As cranberries are a fresh acidic fruit and
chlorimuron-ethyl is applied to the crop when the berries are present,
HED would not typically consider the metabolism data on soybeans,
peanuts, and corn to be representative of berries.  However, because the
proposed uses are on minor crops (low-growing berries) and the harvest
interval (60 days) is similar to the minimum harvest intervals for
soybean and peanuts, HED will not require a new metabolism study for
this petition.  For purpose of this petition only, the residue of
concern in/on berries is chlorimuron-ethyl per se.

For the corn metabolism study the petitioner should provide the dates of
sample extraction and analysis to confirm that the majority of the
immature samples were initially analyzed within ~6 months of harvest.
Confirmatory data should be submitted to validate that these samples
were analyzed within ~6 months of harvest.  This information may be
provided in a future tolerance petition.

860.1300 Nature of the Residue - Livestock

There are no livestock feedstuffs associated with the proposed use on
low-growing berries.  Therefore, data requirements for livestock
metabolism are not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

HED previously identified and addressed the following analytical method
deficiencies given below in the review of the current petition (DP#
346842, A. Parmar, 3/12/2007) and (E-Mail Communication, A. Parmar to B.
Madden 7/01/2008).

Proposed Enforcement Methods Deficiency

DP# 346842, A. Parmar, 3/12/2007

Deficiency:  The petition states that there is an adequate enforcement
method.  However, though the current enforcement method is adequate for
soybeans and peanuts; there has been no testing to ensure the method is
adequate for chlorimuron-ethyl in cranberries.  Since the cranberry data
collection method is very different from the current enforcement method,
the EPA cannot conclude that the enforcement method would be likely to
be sufficient for cranberry (and other berries).  Since there's no
metabolism study with cranberry, radiovalidation data cannot be
generated.  Data where cranberry samples were analyzed using the
proposed (existing) enforcement method, to determine if it would be
adequate should be provided.

Petitioner’s Response:  The registrant has recently submitted
analytical method AMR 3210-94 Entitled: Analytical Method (Column
Switching/Heart Cut) For the Determination of Residues of
Chlorimuron-ethyl (DPX-F6025) and Metsulfuron Methyl (DPX-T6376) in Rice
Grain (MRID# 47263901).  This method includes the extraction procedure
used in study 03023 chlorimuron-ethyl: Magnitude of the Residue in
Cranberry and this method would now be considered the enforcement method
for cranberry (MRID# 47004901).  Since the concurrent recoveries were
satisfactory (average recovery was above 80%), the method was
demonstrated to be adequate for cranberry.

HED’s Conclusion:  Until the petitioner submits an independent lab
validation of the proposed plant enforcement method or can demonstrate
that the existing enforcement method provides satisfactory performance
on cranberries, HED cannot conclude this deficiency is resolved.

E-Mail Communication, A. Parmar to B. Madden, 7/01/2008

Petitioner’s Follow-up Response:  IR-4 provided a rationale supporting
a waiver of the ILV.  During IR-4 communications with the Analytical
Chemistry Branch (ACB) (C. Stafford) it was agreed that the rice
analytical method trial would be a viable surrogate for the cranberry
ILV.

HED’s Follow-up Conclusion:  IR-4 has now submitted sufficient
information for HED to conclude that the rice analytical method is a
viable surrogate for the cranberry ILV trial.  ACB agrees that in lieu
of a cranberry ILV, the review of the cranberry method and rice method
can together serve as the primary method plus ILV data (Personal
Communications C. Stafford to R. Loranger).  After further consideration
and extensive consultation with ACB, HED will accept the rice analytical
method as a surrogate for the cranberry analytical method ILV based on
the following:

ACB feels that given the aqueous solubilities of sulfonylureas, the
aqueous extraction is likely to be adequate.

The methods employ similar extraction procedures, solvents, and
equipment.

The methods were performed at separate labs belonging to DuPont & IR-4.

Both methods resulted in adequate recoveries with similar recovery
efficiencies.  The cranberry method validation recovery was 82% with a
standard deviation of 3%.  The rice method validation recovery was 75%
with a standard deviation of 8% (Table 8).

TABLE 8.	Summary of Recoveries of Chlorimuron-Ethyl from Fortified
Cranberry and Rice Samples.

Matrix	Spike Level

(ppm)	Sample Size

(n)	Recoveries

(%)	Mean ± Std. Dev.

(%)

Method validation

Cranberries	0.02	3	81, 77, 87	82  ± 5

	0.2	3	82, 83, 81	82 ± 1

	Total	6	77-87	82 ± 3

Concurrent Recovery

Cranberries	0.02	8	84, 81, 82, 81, 77, 87, 80, 75	81 ± 4

Method validation

Rice	0.02	7	57, 82, 83, 85, 59*, 79, 65	73 ± 12

	0.04	7	78, 75, 76, 80, 75*, 82, 70 	77 ± 3.9

	0.10	7	74, 69, 85, 80, 81*, 80, 67	77 ± 6.7

	Total	21	57-85	75 ± 8.1

* net % recoveries are: (ppm found fortified sample - ppm found control
sample)

Current Enforcement Methods

Two HPLC methods are available for enforcing tolerances of
chlorimuron-ethyl in soybeans and peanuts. The original enforcement
method for soybeans (AMR-459-85) is found in Pesticide Analytical Manual
(PAM) Volume II.  For this method, residues are extracted with
dichloromethane, filtered, diluted with water, and concentrated to an
aqueous remainder.  The aqueous fraction is partitioned against hexane,
discarding the hexane phase, and residues are then partitioned into
dichloromethane and cleaned up using a silica gel cartridge.  Residues
are concentrated to dryness and redissolved in HPLC mobile phase
(hexane/isopropanol/methanol /glacial acetic acid/water;
750:125:125:2:1).  Residues are then determined by HPLC using a
photoconductivity detector.  The method LOQ is 0.01 ppm.

An HPLC/UV method is also available for peanuts (AMR-990-87).  This
method differs slightly from the above method primarily in the use of
different solvents for the sample preparation step.  The method LOQ is
0.02 ppm for peanut nutmeat and 0.05 ppm for peanut hulls.

Neither current enforcement method has been validated using a crop
matrix similar to berries.

Data Collection Method Deficiency

DP# 346842, A. Parmar, 3/12/2007

Deficiency:  The petition states that the data collection method is
adequate to conclude the submitted field trial data support the proposed
tolerances.  However, the aqueous extraction method used in the analysis
of the cranberry field trial samples is untested.

Further, there is no record of the EPA having received the extraction
method cited in the study report (DuPont method AMR 3210-94 for rice).

Petitioner’s Response:  With respect to responses given above for the
proposed enforcement method, we feel that the existing information
should address this concern.

HED’s Conclusion:  The registrant has submitted the DuPont method AMR
3210-94 containing the aqueous extraction method employed in the
cranberry field trial.  The aqueous extraction method has been tested in
rice, and demonstrated adequate recoveries.  HED considers this
deficiency resolved.

Data Collection Method Review

47004901.der (cranberry)

Samples from the cranberry field trials were analyzed for
chlorimuron-ethyl using an HPLC/photoconductivity method that was
derived from two other methods.  Samples were extracted and purified
using procedures from “Analytical Method (Column Switching/Heart Cut)
for the Determination of Residues of Chlorimuron-ethyl (DPX-F6025) and
Metasulfuron Methyl (DPX-T6376) in Rice Grain, DuPont Report No. AMD
3210-94”.  Residues were then quantified using procedures from
“Analysis of Chlorimuron-ethyl in Crops by High Performance Liquid
Chromatography”.

For this method, cranberry samples were extracted with 0.1 M phosphate
buffer, centrifuged, adjusted to pH 5, and filtered.  The filtrate was
then eluted through an EMPORE ™ C18 extraction disk, which retained
the chlorimuron-ethyl.  Residues were eluted from the C18 disk with
ethyl acetate, concentrated to dryness, and redissolved in 0.03 M
phosphate buffer (pH 5).  Residues were next partitioned into
dichloromethane, concentrated to dryness and then redissolved in the
HPLC mobile phase (hexane/isopropanol/methanol, 80:10:10 (v/v/v), with
0.2% glacial acetic acid and 0.1% water).  Residues of chlorimuron-ethyl
were determined by normal-phase HPLC using a silica column with an
isocratic mobile phase and a photoconductivity detector.  The
statistically calculated LOQ and LOD were 0.0084 and 0.0028 ppm,
respectively.  The lowest level of method validation was 0.020 ppm.

The method was adequately validated in conjunction with the analysis of
field trial samples using control samples of cranberry fortified with
chlorimuron-ethyl at 0.02 and 0.2 ppm.

Conclusions.  An adequate HPLC photoconductivity method was used for
data collection.  The validated LOQ for chlorimuron-ethyl residues in
berries is 0.02 ppm.

860.1360 Multiresidue Methods

Multiresidue method testing data are available for chlorimuron-ethyl
(Pesticide Analytical Manual, Vol. I, Appendix I).  Chlorimuron-ethyl is
poorly recovered (<50%) through Method 302 and not recovered through
Method 303.

860.1380 Storage Stability

The petitioner cited data from earlier petitions from DuPont on soybeans
and corn indicating that chlorimuron-ethyl is stable at -20°C for up to
24 months in homogenized samples of soybeans and field corn grain,
forage and fodder.

% over 24.5 months of storage (↓1.39% per month).

In comparing the stability data from soybean and corn with the above
cranberry study, the petitioner noted that the instability of
chlorimuron-ethyl in cranberries during frozen storage may be
attributable to the acidic nature of the fruit.

The storage durations and conditions of samples from the cranberry field
trials submitted to support this petition are presented in Table 9.

Table 9.	Summary of Storage Conditions and Durations of Samples from
Cranberry Field Trial Studies.

Matrix 	Storage Temperature   (°C)	Actual Storage Duration (days)
Interval of Demonstrated Storage Stability (days)

Cranberry	-20	807-817	747 1

1	Chlorimuron-ethyl residues declined by 34% after 24.5 months of
storage at -20°C.

Conclusions.  As no 0-day analysis was conducted on the fortified
samples of cranberry prior to storage, the cranberry storage stability
study is not fully acceptable.  However, for purposes of this petition,
HED will use the available data to correct the cranberry residue data
for potential declines of 1.39% per month during frozen storage.

860.1400 Water, Fish, and Irrigated Crops

There are no proposed uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no proposed uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

There are no livestock feedstuffs associated with the proposed use on
low-growing berries.  Therefore, data requirements pertaining to meat,
milk, poultry and eggs are not relevant to this tolerance petition.

860.1500 Crop Field Trials

47004901.der (Cranberry)

IR-4 submitted cranberry field trial data supporting the proposed uses
of chlorimuron-ethyl (WDG) on low-growing berries, except strawberry.
Cranberry is the representative crop for subgroup 13-07H.  The results
from these studies are discussed below and the residue data are
summarized in Table 10.

TABLE 10.	Summary of Residue Data from Crop Field Trials with
Chlorimuron-Ethyl (WDG).

Commodity	Total Applic. Rate

(lb ai/A)	PHI (days)	Residue Levels (ppm) 1,3

	n	Min.	Max.	HAFT 2	Median

(STMdR)	Mean

(STMR)	Std. Dev.

Cranberry	0.015-0.017	57-63	10	<0.0044	<0.0044	<0.0044	--	<0.0044	0

1	The calculated LOQ and LOD were 0.0084 and 0.0028 ppm, respectively.
The LLMV was 0.02 ppm.

2	HAFT = Highest Average Field Trial.

3	The value of <0.0044 ppm was derived by correcting non-detectable
residues (<0.0028 ppm) for a potential storage stability declines of
37%.  Corrected Residue Value: 0.0044 ppm = 0.0028 ppm (LOD) / 37%
(Potential Storage Decline)

In 5 field trials conducted during 2001 in EPA Growing Regions 1, 5 and
12, a 25% water-dispersible granular (WDG) formulation of
chlorimuron-ethyl was applied to cranberries as a single broadcast
foliar application during fruit development at 0.015-0.017 lb ai/A.
Applications were made using ground equipment in volumes of 20-22 gal/A,
and included the use of either a crop oil concentrate (COC) at 1.0% (1
test) or non-ionic surfactant (NIS) at 0.25% (4 tests).  Single control
and duplicate treated samples of mature cranberries were harvested from
each test at 57-63 days after treatment (DAT).

Samples were stored frozen (-20°C) for up to ~27 months prior to
extraction for analysis.  The available storage stability data indicate
that chlorimuron-ethyl residues can decline by 34% over 25 months for
frozen storage.  Therefore, residues in cranberry samples have been
corrected based on a decline of 1.39% per month of storage.

Residues in/on cranberries were determined using an
HPLC/photoconductivity detector method that was adequately validated
prior to an in conjunction with the analysis of field trial samples.
The statistically calculated LOQ and LOD were 0.0084 and 0.0028 ppm,
respectively, and the LLMV was 0.020 ppm.

Following a single broadcast foliar application of chlorimuron-ethyl
(WDG) at a 1x rate, uncorrected residues of chlorimuron-ethyl were
non-detectable (<0.0028 ppm) in/on all 10 samples of cranberries
harvested at 57-63 DAT.  If residue values are corrected to account for
a potential 37% decline during frozen storage, the resulting residues
(<0.0044 ppm) are still well below the method LOQ (0.0084 ppm) and the
LLMV (0.02 ppm).

Conclusions.  The cranberry field trial data are adequate and support
the proposed use pattern for low-growing berries, except strawberry.  An
adequate number of tests were conducted in the appropriate geographical
regions, and samples were analyzed for residues of concern using an
adequate data collection method.  Although the available storage
stability data indicate that residues in/on cranberries should be
corrected for a potential decline of 37% during frozen storage, the
corrected residue data still indicate that residues in/on cranberries
would be well below the proposed 0.02 ppm tolerance.

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities
associated with low-growing berries.  Therefore, data requirements for
processed food and feed are not relevant to this tolerance petition.

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference
Standards

An analytical standard for chlorimuron-ethyl is currently available in
the National Pesticide Standards Repository (T. Cole, personal
communication, 9/27/07).

860.1850-1900 Confined and Field Accumulation in Rotational Crops

Because low-growing berries are not rotated crops, no data pertaining to
rotational crops are required to support the proposed use.

860.1550 Proposed Tolerances

For the registered uses on soybeans and peanuts, HED has concluded that
the residues of concern for tolerance expression and risk assessment
should include only chlorimuron-ethyl.  Tolerances are presently
established for residues of chlorimuron-ethyl at 0.02 and 0.05 ppm in/on
peanut and soybean seed, respectively [40 CFR §180.429(a)].  For
purposes of this petition on low-growing berries, HED will also consider
the parent compound to be the only residue of concern.

Residues of chlorimuron-ethyl were ND (<0.0028 ppm) on all samples of
cranberries harvested ~60 days (proposed PHI) after an application at a
1x rate.  Even if residues are corrected for potential decline during
storage, the maximum residues in/on cranberries (<0.0044 ppm) would
still be well below the validated method LOQ of 0.02 ppm.  Therefore,
the proposed 0.02 ppm tolerance is adequate.  Due to all residues being
non-quantifiable, the NAFTA harmonization spreadsheet was not used to
derive the recommended tolerance level.

IR-4 has proposed establishing separate tolerances at 0.02 ppm on the
members of the low-growing berries subgroup (except strawberry; subgroup
13H).  However, as the proposed revisions to the berry crop group have
been finalized (72 FR 69150, 12/7/2007), a separate tolerance for each
member of the subgroup is not necessary.  Provided the registration is
granted, a single tolerance should be established for residues of
chlorimuron-ethyl at 0.02 ppm in/on the low-growing berry subgroup
13-07H, except strawberry.

  SEQ CHAPTER \h \r 1 No international harmonization issues are
associated with this petition, as there are no established or proposed
Canadian, Mexican or Codex MRLs for residues of chlorimuron-ethyl on the
proposed crops (Appendix I).

Table 11. 	Tolerance Summary for Chlorimuron-Ethyl.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments;
Correct Commodity Definition

Bearberry	0.02	0.02	Adequate data are available on the representative
crop of cranberry.

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References

DP Number:	None

Subject:	PP#3G2959

From:	S. Creeger

To:	not available

Dated:	1/10/1984

MRID(s):	not available

DP Number:	301317

Subject:	Chlorimuron-Ethyl.  Human Health Risk Assessment

From:	R. Griffin

To:	S. Sherman

Dated:	8/31/2004

MRID(s):	none

  SEQ CHAPTER \h \r 1 Attachments:

Appendix I - International Tolerances

Appendix I - International Tolerances

INTERNATIONAL RESIDUE LIMIT STATUS

Chemical Name: ethyl
2-[[[[(4-chloro-6-methoxy-2-pyrimidinyl)amino]carbonyl]amino]sulfonyl]
benzoate	Common Name:  Chlorimuron-ethyl	(  Proposed tolerance

 Reevaluated tolerance

 Other	Date: 1/03/08

Codex Status (Maximum Residue Limits)	U. S. Tolerances

( No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition
Number:  6E7153

DP Number:  335807

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 No Limits

( No Limits for the crops requested	( No Limits

 No Limits for the crops requested

Residue definition: N/A	Residue definition: N/A

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

	Notes/Special Instructions:

Page   PAGE  1  of   NUMPAGES  19

Chlorimuron-Ethyl	Summary of Analytical Chemistry and Residue Data	DP#:
335807


   The SBREFA Panels for Infectious Diseases will convene at the Department of Labor, Francis Perkins Building, located at 200 Constitution Ave, NW, Washington, DC in Conference Room S-2217 on the dates and times listed below:
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   1. Chris Albritton
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Keswick Multi-Care Center

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   12. Kayvon Haghighi, D.D.S., M.D.

   13. Dr. Melissa Heche, AuD.

   14. John Hitchens
Watchful Care

   15. Becky Keller, RN BSN
Compliance Officer
Pathways Hospice

   16. Rick Kislia
Crescent Laundry

   17. Sue Luster
Home Health Options Group, Inc.

   18. Leslie Marsh, RN, MBA, MSN, the CEO
Lexington Regional Health Center

   19. Hal Miller
General Manager
Larson-Miller Medical Waste Disposal Service

   20. Ms. Carol Moehrle
Public Health Director
Idaho North Central District (Nez Perce County)

   21. Jenna Moerk
Hillside Memorial Park and Mortuary

   22. Dr. Trevor Neal
Office of Podiatrists

   23. Rich Norcross
Medical Waste Services

   24. Philip Obiedzinski, DPM
50 Orient Way

   25. Todd Opp
Glendive Medical Center Acute Care Hospital

   26. Jim Parks
Accu Medical Waste Service, Inc.

   27. Lyn Pethtel
Salem Community Hospital

   28. Dr. Janice K. Pliszczak, DDS, MS, MBA, MAGD
Office of Dentists

   29. Douglas Rodriguez
Fishers Pediatric Dentistry

   30. Julie Rowland
Scottsdale Eye Surgery Center

   31. John J. Russell, MD
Cape County Private Ambulance Service, Inc.

   32. Jim Sakell
Cypress Glen Retirement Community

   33. John Dallas Slack, CFSP
Slack Funeral Home, P.A.

   34. Douglas L. Smith, MD
Associate Chief Medical Officer
Intermountain Healthcare

   35. Janet Snipes, NHA
Holly Heights Nursing Home, Inc.

   36. Georgine Snyder , RN, COHN-S
Diakon Lutheran Social Ministries

   37. Jonathan Stark
Director of Plant Operations & Safety Officer
Alice Peck Day Memorial Hospital

   38. Patti Tatlock
St. Mary's Hospital

   39. Mindy Thompson, PHR
Human Resource Manager
Helen R. Walton Children's Enrichment Center

   40. Saul Wasserman
Health and Safety Officer
Shiel Medical Laboratory

   41. David J. Weber, CFSP,CCO
David J. Weber  Funeral Homes, P.A.

   42. Stacy Weisend, Au.D, FAAA

   43. Mary Yarbrough
Vanderbilt University and Medical Center

   44. Carole Yeung, RN CIC
Baptist Home Health Network