[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Pages 14657-14658]
[FR Doc No: 2011-6230]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2010-0356; FRL-9281-8]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS for Asphalt Processing and
Roofing Manufacture (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before April 18,
2011.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2010-0356, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; and (2)
OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia A. Williams, Compliance
Assessment and Media Programs Division, Office of Compliance, Mail Code
2223A, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER> fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 2, 2010 (75 FR 30813), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2010-0356 which is available for public viewing
online at http://www.regulations.gov, or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov.
    Title: NSPS for Asphalt Processing and Roofing Manufacture
(Renewal).
    ICR Numbers: EPA ICR Number 0661.10, OMB Control Number 2060-0002.
    ICR Status: This ICR is scheduled to expire on April 30, 2011.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of

information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA's regulations in title 40 of the CFR,
after appearing in the Federal Register when approved, are listed in 40
CFR part 9, and displayed either by publication in the Federal Register
or by other appropriate means, such as on the related collection
instrument or form, if applicable. The display of OMB control numbers
in certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The New Source Performance Standards (NSPS) for Asphalt
Processing and Roofing Manufacture (40 CFR part 60, subpart UU) were
proposed on November 18, 1980, and promulgated on May 26, 1981. These
standards apply to each saturator and each asphalt storage facility at
asphalt roofing plants; and to each asphalt storage tank and each
blowing still at asphalt processing plants, petroleum refineries, and
asphalt roofing plants. New facilities include those that commenced
construction, modification, or reconstruction after the date of
proposal. This information will be used by enforcement agencies to
verify that sources subject to the standard are meeting the emission
reductions mandated by the Clean Air Act.
    Owners/operators of asphalt processing and roofing manufacture are
required to submit one-time only notification of construction/
reconstruction, actual startup, initial performance test, physical or
operational changes, and demonstration of a continuous monitoring
system. Records must be maintained of the occurrence and duration of
any startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative. These notifications reports, and records are essential in
determining compliance; and, in general, are required of all sources
subject to NSPS.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
two years following the date of such measurements, maintenance reports,
and records. All reports are sent to the delegated state or local
authority. In the event that there is no such delegated authority, the
reports are sent directly to the EPA regional office. This information
is being collected to assure compliance with 40 CFR part 60, subpart
UU, as authorized in section 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that have been determined to be private.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 113
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Asphalt processing and roofing
manufacturers.
    Estimated Number of Respondents: 144.
    Frequency of Response: Initially, and semiannually.
    Estimated Total Annual Hour Burden: 33,912.
    Estimated Total Annual Cost: $8,686,825, which includes $200,000 in
annualized Capital/Startup costs, $5,040,000 in annualized Operating
and Maintenance (O&M) costs, and $3,446,825 in annualized labor costs.
    Changes in the Estimates: There is no change in the labor hours or
cost to the respondents in this ICR compared to the previous ICR. This
is due to two considerations: (1) the regulations have not changed over
the past three years and are not anticipated to change over the next
three years; and (2) the growth rate for the respondents is very low,
negative, or non-existent. Therefore, the labor hours and cost figures
in the previous ICR reflect the current burden to the respondents and
are reiterated in this ICR.

    Dated: March 11, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-6230 Filed 3-16-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 90 (Thursday, May 9, 2013)]
[Notices]
[Pages 27281-27284]
[FR Doc No: 2013-11066]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Docket No. FMCSA-2013-0028]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 25 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. They are unable to meet the vision requirement in
one eye for various reasons. The exemptions will enable these
individuals to operate commercial motor vehicles (CMVs) in interstate
commerce without meeting the prescribed vision requirement in one eye.
If granted, the exemptions would enable these individuals to qualify as
drivers of commercial motor vehicles (CMVs) in interstate commerce.

DATES: Comments must be received on or before June 10, 2013.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0028 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System (FDMS) published in the Federal Register on January
17, 2008 (73 FR 3316).

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-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.'' FMCSA can renew exemptions at the end of each
2-year period. The 25 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Allan L. Anthony

    Mr. Anthony, age 54, has had refractive amblyopia in his left eye
since birth. The visual acuity in his right eye is 20/30, and in his
left eye, counting fingers. Following an examination in 2013, his
optometrist noted, ``It is, in my opinion, that Mr. Anthony's vision is
sufficient for operation of a commercial motor vehicle.'' Mr. Anthony
reported that he has driven straight trucks for 29 years, accumulating
188,500 miles, and tractor-trailer combinations for 29 years,
accumulating 58,000 miles. He holds a Class A Commercial Driver's
License (CDL) from Maryland. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

James C. Barr

    Mr. Barr, 55, has had strabismic amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/160. Following an examination in 2012, his optometrist noted,
``In my medical opinion, Mr. Barr has sufficient central and peripheral
vision; as well as, sufficient gross depth perception to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Barr
reported that he has driven straight trucks for 7 years, accumulating
350 miles. He holds a Class B CDL from Ohio. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Clifford L. Burrus

    Mr. Burruss, 71, has had refractive amblyopia in his right eye
since childhood. The visual acuity in his right eye is 20/100, and in
his left eye, 20/20. Following an examination in 2013, his optometrist
noted, ``Since Mr. Burruss has been a professional truck driver for 40
years with an accident free driving

record, it is my opinion that his vision is satisfactory to continue in
his occupation for the next two years.'' Mr. Burruss reported that he
has driven straight trucks for 1 year, accumulating 60,000 miles, and
tractor-trailer combinations for 40 years, accumulating 5 million
miles. He holds a Class A CDL from California. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Brian G. Dvorak

    Mr. Dvorak, 53, has had myopia in his left eye since childhood. The
visual acuity in his right eye is 20/20, and in his left eye, 20/50.
Following an examination in 2012, his ophthalmologist noted, ``Mr.
Dvorak has the ability to recognize the colors of traffic control
signals and devices and in my opinion has sufficient vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr.
Dvorak reported that he has driven tractor-trailer combinations for 27
years, accumulating 270,000 miles. He holds a Class AM CDL from
Illinois. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Roger Dykstra

    Mr. Dykstra, 58, has a central scotoma in his left eye due to a
traumatic incident in 1986. The visual acuity in his right eye is 20/
20, and in his left eye, 20/400. Following an examination in 2012, his
ophthalmologist noted, ``Enclosed is a copy of the formal perimetry
test which indicates that the patient has a 120 degree field of vision
and it is my medical opinion that Mr. Dykstra is able to operate his
service truck for his employment in the same safe manner that he has
done since his employment in 1995.'' Mr. Dykstra reported that he has
driven straight trucks for 40 years, accumulating 580,000 miles. He
holds a Class B CDL from Illinois. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Gerald R. Eister

    Mr. Eister, 48, has had aniridia in his left eye since 2009. The
visual acuity in his right eye is 20/20, and in his left eye, light
perception. Following an examination in 2013, his optometrist noted,
``So with the right eye seeing 20/20 without correction and the left
eye having good peripheral I feel he is safe to operate a commercial
vehicle.'' Mr. Eister reported that he has driven straight trucks for
28 years, accumulating 873,600 miles, and tractor-trailer combinations
for 10 years, accumulating 100,000 miles. He holds a Class A CDL from
North Carolina. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Juan M. Guerrero

    Mr. Guerrero, 40, has had optic atrophy in his right eye since
1993. The visual acuity in his right eye is counting fingers, and in
his left eye, 20/20. Following an examination in 2012, his optometrist
noted, ``Patient has sufficient vision to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Guerrero reported that
he has driven straight trucks for 13 years, accumulating 1.2 million
miles. He holds a Class A CDL from Texas. His driving record for the
last 3 years shows no crashes and one conviction for a moving violation
in a CMV; he ran a stop sign.

Michael L. Huffman

    Mr. Huffman, 59, has had strabismic amblyopia in his left eye since
childhood. The visual acuity in his right eye is 20/20, and in his left
eye, 20/400. Following an examination in 2013, his optometrist noted,
``Based on his visual findings and his previous work and driving
experience, I feel as though Mr. Huffman has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Huffman reported that he has driven straight trucks for 38 years,
accumulating 3.8 million miles, tractor-trailer combinations for 3
years, accumulating 102,000 miles, and buses for 1.5 years,
accumulating 750 miles. He holds a Class A CDL from Iowa. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

John T. Johnson

    Mr. Johnson, 34, has a retinal detachment in his right eye due to a
traumatic incident in 1998. The visual acuity in his right eye is 20/
200, and in his left eye, 20/20. Following an examination in 2013, his
optometrist noted, ``Given the stability of his exam, his excellent
visual acuity, color vision and visual field in the left eye, he should
be able to continue operating a commercial vehicle from a vision
standpoint.'' Mr. Johnson reported that he has driven straight trucks
for 13 years, accumulating 650,000 miles, and tractor-trailer
combinations for 13 years, accumulating 650,000 miles. He holds a Class
A CDL from New Mexico. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Kevin S. Kacicz

    Mr. Kacicz, 42, has a cataract in his left eye due to a traumatic
incident during childhood. The best corrected visual acuity in his
right eye is 20/25, and in his left eye, 20/50. Following an
examination in 2012, his optometrist noted, ``I certify that I have
reviewed the federal requirements for drivers of interstate commercial
vehicle with respect to vision, and in my opinion, the above patient
does meet the federal requirements for vision for interstate commercial
vehicle operators.'' Mr. Kacicz reported that he has driven straight
trucks for 15 years, accumulating 699,990 miles, and tractor-trailer
combinations for 6 months, accumulating 100,000 miles. He holds a Class
A CDL from Pennsylvania. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Thomas Korycki

    Mr. Korycki, 48, has had amblyopia in his left eye due since
childhood. The best corrected visual acuity in his right eye is 20/20,
and in his left eye, 20/200. Following an examination in 2012, his
ophthalmologist noted, ``Patient has sufficient vision to perform tasks
required to operate commercial vehicle.'' Mr. Korycki reported that he
has driven straight trucks for 33 years, accumulating 33,000 miles. He
holds an operator's license from New Jersey. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

John Kozminski

    Mr. Kozminski, 59, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20,
and in his left eye, 20/400. Following an examination in 2012, his
ophthalmologist noted, ``In my medical opinion, Mr. Kozminski has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Kozminski reported that he has driven
straight trucks for 25 years, accumulating 250,000 miles. He holds a
chauffer's license from Michigan. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Larry W. Lunde

    Mr. Lunde, 60, has a retinal detachment in his right eye due to a
traumatic incident in 2002. The best corrected visual acuity in his
right eye is 20/100, and in his left eye, 20/20. Following an
examination in 2012, his

optometrist noted, ``In my opinion, Larry Lunde has sufficient vision
to perform all tasks required for driving a commercial vehicle.'' Mr.
Lunde reported that he has driven straight trucks for 30 years,
accumulating 150,000 miles, and tractor-trailer combinations for 30
years, accumulating 3.3 million miles. He holds a Class A CDL from
Washington. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

David Matos

    Mr. Matos, 53, has had a prosthetic left eye since birth. The best
corrected visual acuity in his right eye is 20/20, and in his left eye,
no light perception. Following an examination in 2013, his optometrist
noted, ``He has a prosthetic left eye all his life . . . His vision is
20/20 in the right eye . . . I am confident in his ability to continue
to drive a truck or any other commercial vehicle.'' Mr. Matos reported
that he has driven straight trucks for 30 years, accumulating 900,000
miles. He holds a Class B CDL from New York. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Chad Penman

    Mr. Penman, 43, has had optic nerve damage in his right eye since
2006. The visual acuity in his right eye is 20/80, and in his left eye,
20/20. Following an examination in 2013, his optometrist noted, ``In my
opinion Chad has sufficient vision to perform driving tasks required to
operate a commercial vehicle.'' Mr. Penman reported that he has driven
straight trucks for 20 years, accumulating 800,000 miles, and tractor-
trailer combinations for 10 years, accumulating 350,000 miles. He holds
a Class A CDL from Utah. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Raymond Potter

    Mr. Potter, 51, has a prosthetic left eye due to a traumatic
incident in 1991. The visual acuity in his right eye is 20/20, and in
his left eye, no light perception. Following an examination in 2012,
his optometrist noted, ``In my opinion, he has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Potter reported that he has driven straight trucks for 14 years,
accumulating 210,000 miles. He holds an operator's license from Rhode
Island. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

David Rothermel

    Mr. Rothermel, 46, has had high myopia in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/400,
and in his left eye, 20/20. Following an examination in 2013, his
optometrist noted, ``Mr. Rothermel's uncorrected and corrected vision
is more than sufficient to operate a commercial vehicle.'' Mr.
Rothermel reported that he has driven straight trucks for 22 years,
accumulating 660,000 miles. He holds a Class 10 license from Rhode
Island. His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Charles T. Spears

    Mr. Spears, 44, has had a prosthetic left eye since 1993. The best
corrected visual acuity in his right eye is 20/20, and in his left eye,
no light perception. Following an examination in 2013, his optometrist
noted, ``In my medical opinion, Mr. Spears has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Spears reported that he has driven tractor-trailer combinations for
10 years, accumulating 250,000 miles. He holds a Class A CDL from
Virginia. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Brian Tessman

    Mr. Tessman, 56, has had optic nerve hypoplasia in his left eye
since birth. The best corrected visual acuity in his right eye is 20/
15, and in his left eye, 20/400. Following an examination in 2013, his
optometrist noted, ``I certify that you are stable and in my opinion
are sufficient to continue your commercial vehicle operations.'' Mr.
Tessman reported that he has driven straight trucks for 14 years,
accumulating 653,744 miles. He holds an operator's license from
Wisconsin. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Gregory Thurston

    Mr. Thurston, 55, has had anisometropic amblyopia in his left eye
since childhood. The best corrected visual acuity in his right eye is
20/20, and in his left eye, 20/60. Following an examination in 2012,
his optometrist noted, ``In my medical opinion, Mr. Gregory Thurston
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Thurston reported that he has driven
straight trucks for 33 years, accumulating 231,000 miles. He holds a
Class B CDL from Pennsylvania. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Donald R. Torbett

    Mr. Torbett, 47, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/15, and in his
left eye, 20/50. Following an examination in 2012, his optometrist
noted, ``In my opinion, Donald has sufficient vision to continue to
operate a commercial vehicle without glasses.'' Mr. Torbett reported
that he has driven tractor-trailer combinations for 25 years,
accumulating 2.5 million miles. He holds a Class A CDL from Iowa. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Scharron Valentine

    Mr. Valentine, 44, has had a macular scar in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/200,
and in his left eye, 20/20. Following an examination in 2013, his
optometrist noted, ``From these results I believe Mr. Valentine has a
sufficient visual acuity, visual field, and color discrimination to
continue to safely operate a commercial vehicle.'' Mr. Valentine
reported that he has driven tractor-trailer combinations for 3 years,
accumulating 234,000 miles. He holds a Class A CDL from Ohio. His
driving record for the last 3 years shows no crashes and one conviction
for a moving violation in a CMV; he exceeded the speed limit by 12 mph.

Allen D. Weiand

    Mr. Weiand, 62, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20, and in his
left eye, 20/60. Following an examination in 2013, his optometrist
noted, ``In my medical opinion Allen Weiand's vision status is stable,
and I would also state that he has sufficient vision to safely operate
a motor vehicle (a commercial motor vehicle).'' Mr. Weiand reported
that he has driven straight trucks for 45 years, accumulating 900,000
miles, and tractor-trailer combinations for 40 years, accumulating
200,000. He holds Class A CDL from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

James Whiteway

    Mr. Whiteway, 61, has had central corneal opacity in his left eye
since 2000. The best corrected visual acuity in his right eye is 20/20,
and in his left eye, 20/80. Following an examination in

2013, his ophthalmologist noted, ``I feel that Mr. Whiteway has
sufficient vision ability to operate a commercial vehicle.'' Mr.
Whiteway reported that he has driven straight trucks for 12 years,
accumulating 800,000 miles, tractor-trailer combinations for 30 years,
accumulating 3 million miles, and buses for less than one year,
accumulating 50,000 miles. He holds a Class A CDL from Texas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Billy W. Wilson

    Mr. Wilson, 55, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/25, and in his
left eye, 20/200. Following an examination in 2013, his optometrist
noted, ``Sufficient vision to perform commercial driving tasks.'' Mr.
Wilson reported that he has driven tractor-trailer combinations for 24
years, accumulating 1.8 million miles. He holds a Class AM CDL from
Tennessee. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business June 10, 2013. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable. In addition to late comments,
FMCSA will also continue to file, in the public docket, relevant
information that becomes available after the comment closing date.
Interested persons should monitor the public docket for new material.

    Issued on: April 30, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-11066 Filed 5-8-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74668-74669]
[FR Doc No: 2012-30297]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0298; Formerly Docket No. 2004D-0499]

Compliance Policy Guide; Radiofrequency Identification
Feasibility Studies and Pilot Programs for Drugs; Notice To Extend
Expiration Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of expiration date.

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

SUMMARY: The Food and Drug Administration (FDA) is extending the
expiration date of compliance policy guide (CPG) Sec. 400.210 entitled
``Radiofrequency Identification (RFID) Feasibility Studies and Pilot
Programs for Drugs'' to December 31, 2014.

FOR FURTHER INFORMATION CONTACT: Connie Jung, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 4268, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2004
(69 FR 67360), FDA announced the

availability of CPG Sec. 400.210 entitled ``Radiofrequency
Identification (RFID) Feasibility Studies and Pilot Programs for
Drugs.'' Previous extensions of the expiration date of the CPG were
published in 2007, 2008, and 2010 (72 FR 65750, November 23, 2007; 73
FR 78371, December 22, 2008; 75 FR 80827, December 23, 2010). FDA has
identified RFID as a promising technology to be used in the various
efforts to combat counterfeit drugs. The CPG describes how the Agency
intends to exercise its enforcement discretion regarding certain
regulatory requirements that might otherwise be applicable to studies
involving RFID technology for drugs. The goal of the CPG is to
facilitate performance of RFID studies and to allow industry to gain
experience with the use of RFID technology and its effect on the long-
term safety and integrity of the U.S. drug supply.
    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (Pub. L. 110-85) (FDAAA) was signed into law. Section 913
of FDAAA addressed pharmaceutical safety and created section 505D of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
355e). Section 505D(b) of the FD&C Act requires the development of
standards for the identification, validation, authentication, and
tracking and tracing of prescription drugs. Section 505D(b)(3) of the
FD&C Act states that these new standards must address promising
technologies, which may include RFID technology.
    In implementing section 505D of the FD&C Act, FDA is currently
addressing issues, such as promising technologies, that also are
relevant for the CPG. In addition, FDA is considering further the
experience of stakeholders and the Agency under the CPG. As we consider
all of these issues, the CPG will remain in effect until December 31,
2014.

    Dated: December 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30297 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P


MEMORANDUM

Date:		11/27/07

Subject:	Flutolanil.  Human Health Risk Assessment. Requests for Inadvertent or Indirect Tolerances for Use on Soybean, Wheat, Corn and Cotton.

PP#s	6F7070,  0F6159	40 CFR:	180.484

PC Code:	128975	Decision #s:	303953, 367541

DP Num:	335050, 334156	Trade Names	Moncut( 50WP

Moncut( 70WP

From:	Felecia Fort, Senior Chemist/Risk Assessor

	Byong-Han Chin, Toxicologist

	Reregistration Branch 1

	Health Effects Division (HED) (7509P)

Through:	Kit Farwell, Senior Scientist

		Reregistration Branch 1 (RRB1)

		Health Effects Division (HED) (7509P)

To:		Lisa Jones/Mary Waller, PM Team 21

		Fungicides Branch

		Registration Division (7505P)

The Health Effects Division (HED) has conducted a human health risk assessment for the fungicide flutolanil to estimate the risk to human health that will result from proposed and registered uses of flutolanil.  Nichino America, Inc. (formerly Nihon Nohyaku) has submitted two petitions proposing the establishment of permanent tolerances for indirect or inadvertent residues in/on corn and cotton (PP#6F7070) and soybean and wheat commodities (PP#0F6159).

The risk assessment, the residue chemistry data review, and the dietary risk assessment were provided by F. Fort and the hazard assessment was provided by Byong-Han Chin.

  SEQ CHAPTER \h \r 1 1.0	EXECUTIVE SUMMARY

Flutolanil [N-[3-(1-methylethoxy)-phenyl]-2-(trifluoromethyl)-benzamide] is a mildly systemic benzanilide fungicide.  Flutolanil has both preventative and curative actions against economic pests such as Rhizoctonia solani, which is the causal agent of limb/pod rot in peanuts, sheath blight in rice, and black scurf in potatoes.  Flutolanil is also effective in controlling white mold in peanuts and rust diseases of several crops.  Flutolanil is currently registered for application to peanuts, potatoes, and rice.

The proposed tolerances for corn and cotton commodities are for residues of the fungicide flutolanil and the metabolite desisopropyl flutolanil a.k.a. M-4 in/on the following raw agricultural commodities (RACs):

Corn, field, forage 	0.30 ppm

Corn, field, grain 	0.20 ppm

Corn, field, stover 	0.30 ppm

Cotton, undelinted seed	0.20 ppm

The proposed tolerances for soybean and wheat commodities are for residues of flutolanil and its metabolites converted to 2-trifluoromethyl benzoic acid and calculated as flutolanil in or on the following RACs and processed commodities:

Soybean forage 	8.0 ppm

Soybean hay 	2.0 ppm

Soybean seed 	0.20 ppm

Wheat forage 	2.0 ppm

Wheat grain 	0.05 ppm

Wheat hay 	0.5 ppm

Wheat straw 	0.2 ppm

Wheat bran 	0.3 ppm

The submitted toxicology data base for technical flutolanil is complete.  No additional studies are required to support the proposed or registered uses of flutolanil.  The database is considered sufficient to clearly define the toxicity of flutolanil.

In general, the toxicology studies conducted on flutolanil demonstrate few or no biologically significant toxic effects at relatively low-dose levels in animal studies and only mild or no toxic effects at high doses.   The subchronic and chronic toxicity studies showed that the primary effects of flutolanil are increases in liver weight combined with decreases in body weight.   The toxicological database indicates that technical grade flutolanil has relatively low acute toxicity (Category III and IV).  Flutolanil is not a dermal sensitizer, primary eye irritant, or primary skin irritant.  Flutolanil is also not neurotoxic, carcinogenic, nor mutagenic.  Flutolanil is not a developmental or reproductive toxicant.  There is no evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to post-natal exposure to flutolanil.  No toxic effects were observed in studies in which flutolanil was administered by the dermal routes of exposure.

≤1% cPAD).

In addition to food and drinking water, the use pattern for flutolanil is expected to result in exposure to the general population through residential settings from use on turf.  Exposures can also occur for occupational handlers loading or applying flutolanil, as well as through postapplication exposure.   However, as previously stated, no appropriate toxicological endpoints of concern was identified in the database based on the lack of adverse effects for these routes of exposure. Consequently, neither a occupational nor residential exposure assessment is required.

Since toxicological endpoints have only been identified for chronic oral exposures, aggregate exposure and risk assessments include only chronic dietary food and water sources of exposure.  As discussed above, the aggregate chronic risk estimates were below the Agency’s level of concern for all population subgroups.

	Recommendation

HED has examined the residue chemistry database for flutolanil.  Due to major issues pertaining to the absence of storage stability to support the lengthy sample storage durations, the submitted data are not acceptable to support reduced PBIs or proposed tolerances for rotated corn and cotton.  Pending submission of a revised section B (see requirements under Directions for Use for soybean and wheat), a revised Section F (see requirements under Proposed Tolerances for soybean and wheat), and the submission of additional data concerning the proposed enforcement method (see requirements under Residue Analytical Methods for Method AU/95R/04), there are no residue chemistry issues that would preclude granting unconditional registration for the requested amended use of flutolanil or establishment of tolerances for indirect or inadvertent residues of flutolanil as follow:

Tolerances to be established under “(d) Indirect or inadvertent residues”:

Soybean, forage	8.0 ppm

Soybean, hay	2.5 ppm

Soybean, seed	0.20 ppm

Wheat, forage	2.5 ppm

Wheat, grain	0.05 ppm

Wheat, hay	1.2 ppm

Wheat, straw	0.20 ppm

Wheat, bran	0.20 ppm

Additionally, analytical standards for metabolites M-2 and M-4 are currently not in stock, and the available standards for metabolites M-3 and M-7 have expired (expiration dates 1/1/04 and 4/1/02, respectively; personal communication with Dallas Wright, ACB, 4/30/07).  Analytical reference standards of flutolanil and its metabolites must be supplied and supplies replenished as requested by the Repository.  For the expired reference standards, the petitioner must either recertify the lot in the repository and send in an updated certificate of analysis (COA), or submit new standards (different lot #) if the previous lots will not be recertified.  If new COAs are being submitted, they should be faxed to the repository at<PHONE_NUMBER>.

Data deficiencies pertaining to rotated corn and cotton need be addressed only if the petitioner intends to pursue reduced plantback intervals (PBI) for these commodities.

2.0	INGREDIENT PROFILE

	2.1	Summary of Registered/Proposed Uses

Tolerances are currently established under 40 CFR §180.484(a)(1) for residues of flutolanil and its metabolites converted to 2-(trifluoromethyl)benzoic acid and calculated as flutolanil in/on peanut, potato, and rice commodities at levels ranging from 0.5 ppm for peanut to 25.0 ppm for rice hulls.  Tolerances for livestock commodities are also established under §180.484(a) at levels ranging from 0.05 ppm for egg, milk, meat, and meat byproducts to 2.0 ppm for liver.

Nichino America, Inc. (formerly Nihon Nohyaku) has submitted two petitions proposing the establishment of permanent tolerances for indirect or inadvertent residues in/on corn and cotton (PP#6F7070) and soybean and wheat commodities (PP#0F6159).  The formulations registered for use on peanuts and rice are Moncut® 50WP (EPA Reg. No. 45639-195) and Moncut® 70WP (EPA Reg. No. 45639-206); these products contain 50% and 70%, respectively, flutolanil as the active ingredient (ai).  Moncut® is a systemic fungicide for control of Southern stem rot (white mold) Sclerotium rolfsii, and limb/pod rot complex, Rhizoctonia solani, in peanuts; and for the control of sheath blight and Rhizoctonia solani, in rice.

rate ≤0.25 lb ai/A.  The 70% DF formulation is currently registered for use on peanuts, rice, and potatoes as broadcast foliar applications in peanuts at up to 2.0 lb ai/A, in-furrow applications in peanuts and potatoes at up to 0.77 lb ai/A, and broadcast foliar applications in rice at up to 1.0 lb ai/A.  The label for the 70% DF formulation specifies PHIs of 40 days for broadcast applications to peanuts and 30 days for rice.  The registered use directions for flutolanil are presented in Table 1; the proposed rotational crop restrictions follow.

Table 2.1.1  Summary of Directions for Use of Flutolanil.

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

Potato

Seed-piece treatment,

Dispensing equipment	1.5% D

[71711-8]	0.75-1.0 lb product/100 lb cut seed	1

made in ≥3 gal/A.  Use of an adjuvant is prohibited.  Use is prohibited in Nassau and Suffolk Counties, NY.

Peanut

Broadcast foliar,

Ground, aerial or chemigation	70% DF

to be made in ≥3 gal/A.  Use of an adjuvant is prohibited.  Use is prohibited in CA and in Nassau and Suffolk Counties, NY.

Rice

Broadcast foliar,

Aerial	70% DF

[71711-14]	0.35-0.70	2	1.00	302	Applications are to be made at first internode elongation at retreatment intervals of 10- to 14-days.  Applications may be made using aerial equipment in 5-10 gal/A.  Use of an adjuvant is prohibited.  Flooded fields may be used for aquaculture of crayfish only following rice harvest.  Use is prohibited in CA and in Nassau and Suffolk Counties, NY.

1  NS = Not specified

2  The label specifies a 30-day PHI or beyond 75% heading development stage, whichever occurs first.

The following rotational crop restrictions are specified for the 1.5% D formulation:  Following total seasonal applications of ≤0.25 lb ai/A, do not plant rotational crops other than labeled crops for 12 months with the following exceptions:  (1) field corn, cotton, soybeans, or wheat may be planted 30 days after last application; (2) leafy vegetables (such as lettuce, spinach, or celery), or small grain crops (such as barley, oats, rye) may be planted 150 days after the last application; and (3) corn (such as sweet or popcorn) and sorghum may be planted 240 days after the last application.  We note that the 150-day PBI for leafy vegetables and small grain crops (including wheat) appears on the accepted label, along with a 12-month restriction for rotational crops other than potatoes, peanuts, or rice.

The following rotational crop restrictions are specified for the 70% DF formulation:  Do not plant rotational crops other than peanuts, rice, or potatoes for 12 months with the following exceptions:  (1) corn, cotton, soybeans, or wheat may be planted 30 days after last application; (2) leafy vegetables (such as lettuce, spinach, or celery), small grain crops (such as barley, rye, or oats), or crops grown for seed (such as grass seed, alfalfa, or timothy) may be planted 150 days after the last application; and (3) root crops (such as sugar beets, onions, carrots, or garlic grown for seed); legume vegetables (such as peas or beans); or sorghum may be planted 240 days after the last application.  We note that the 150-day PBI for leafy vegetables and small grain crops (including wheat) and a 240-day PBI for corn (including field, sweet, and popcorn), sorghum, soybeans, and cotton appear on the accepted label, along with a 12-month restriction for rotational crops other than potatoes, peanuts, or rice.

The 70% DF formulation also specifies the following feeding restrictions for broadcast foliar application to peanuts:  Do not feed hay or threshings from rotational crops of soybeans or cotton planted following the harvest of treated peanuts (>1.00 lb ai/A), and do not allow cattle to graze soybean or cotton forage in these previously treated peanut fields.

	2.2	Structure and Nomenclature

The nomenclature of flutolanil is summarized in Table 2.2.1, and the physicochemical properties are summarized in Table 2.3.1.  The chemical names and structures of flutolanil and its transformation products are presented in Appendix B.

Table 2.2.1 Flutolanil Nomenclature.

Chemical structure

Common name	Flutolanil

Company experimental name	N/A

IUPAC name	α,α,α-trifluoro-3’-isopropoxy-o-toluanilide

CAS name	N-[3-(1-methylethoxy)phenyl]-2-(trifluoromethyl)benzamide

CAS registry number	66332-96-5

End-use product (EP)	MonCoat MZ® (1.5% tree bark based dust formulation; EPA Reg. No. 71711-8; MAI formulation containing mancozeb) and Moncut® 70-DF (70% DF formulation; EPA Reg. No. 71711-14)

Chemical structure of common moiety determined by enforcement method

2-trifluoromethylbenzoic acid (2-TFBA)

	2.3	Physical and Chemical Properties  tc "2.3	Physical and Chemical Properties " \l 2

Table 2.3.1	Physicochemical Properties of Flutolanil.

Parameter	Value	Reference

Melting range	100.4-103.8 °C	DP#s 190584 and 190586, 3/24/94, J. Garbus; MRID 42606601

Ph	5.69

	Density	1.325 @ 20-25

	Water solubility	6.53 mg/L at 20 °C

	Solvent solubility			at 20 °C

Methanol	232 g/L

n-Hexane	  0.9 g/L

	Vapor pressure	4.87 x 10-8 mm Hg at 25 °C

	Dissociation constant, pKa	Not applicable

	Octanol/water partition coefficient, Log(KOW)	log POW = 3.74

	UV/visible absorption spectrum	Not available

HAZARD CHARACTERIZATION/ASSESSMENT

	3.1	Hazard and Dose-Response Characterization

The hazard characterization for flutolanil is discussed in detail in the document entitled Flutolanil on Rice and Potato: Human Health Risk Assessment [DP barcode D268880, September 11, 2000]. The conclusions from that assessment remain unchanged, with the exception that the chronic reference dose (RfD) has been revised, as discussed below.

All toxicological data requirements for a food-use chemical have been satisfied, and the toxicology database for flutolanil is considered complete for the purpose of assessing human health risks. No additional studies are required to support rotational crop tolerances on wheat, soybean, corn, and cotton.

The toxicology studies conducted on flutolanil demonstrate few or no biologically significant toxic effects. Liver effects in rats included increases in absolute and relative liver weight in the absence of clinical chemistry and/or histopathology findings. In dogs, there was an elevation in alkaline phosphatase and cholesterol levels together with dose-related increases in absolute and relative liver weights, slightly enlarged livers, and an increase in severity of glycogen deposition. The increased liver weights are considered to be an adaptive response to flutolanil treatment and not an adverse effect. Based on the lack of evidence of carcinogenicity and the lack of evidence of mutagenicity, flutolanil is classified as “not likely to be carcinogenic to humans”.

Flutolanil is not neurotoxic, and it is not a developmental or reproductive toxicant. No maternal, reproductive, or developmental toxicity was observed at the limit dose. There was no evidence for increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to post-natal exposure to flutolanil.  No toxic effects were observed in studies in which flutolanil was administered by the dermal route of exposure at the limit dose.

Previously, the Health Effects Division (HED) Hazard Identification Assessment Review Committee (HIARC report dated 11/2/99; TXR No. 013851) determined that no appropriate toxicological endpoint attributable to a single oral dose (exposure) was identified in the available data on flutolanil. Therefore, no acute reference dose (RfD) was selected and an acute dietary risk assessment was not required. The HIARC selected a chronic RfD of 0.87 mg/kg/day for use in chronic dietary risk assessment, based on the 2-year combined chronic toxicity/carcinogenicity study in rats in which decreases in body weight/gain and increases in absolute and relative liver weights were observed at the lowest-observable-effect level (LOAEL) of 460 mg/kg/day. The HED Food Quality Protection Act (FQPA) Safety Factor Committee (November 9, 1999) concluded that the 10X FQPA safety factor should be reduced to 1X.

For the current rotational crop tolerances assessment, the flutolanil risk assessment team reevaluated the database and concurred with the HIARC regarding the lack of an appropriate endpoint for the acute RfD and reduction of the FQPA safety factor to 1X. However, the team identified an endpoint from the 2-year chronic dog study as providing a more appropriate endpoint for the chronic RfD. This is based on the conclusion that the liver effects, in the absence of clinical chemistry or histopathological findings, in the chronic rat study used previously, are considered to be an adaptive response and not adverse. In the chronic dog study, the increased incidence of clinical signs (emesis, salivation, and soft stool) at 250 mg/kg/day (LOAEL) occurred following 65 weeks of exposure.  The flutolanil risk assessment team selected a chronic RfD of 0.5 mg/kg/day (NOAEL of 50 mg/kg/day; 10X interspecies factor; 10X intraspecies factor; 1X FQPA SF).

Previously, an assessment of incidental oral exposure was not performed. For the current rotational crop tolerances assessment, the flutolanil risk assessment team concluded that there is no appropriate endpoint for either short-term or intermediate-term incidental oral assessment based on the lack of adverse effects following these exposure durations.

		3.1.1	Database Summary  TC \l3 "3.1.1	Database Summary

A summary of the hazard assessment of flutolanil is provided below. Additional details may be found in the 2000 Human Health Risk Assessment (DP Barcode D268880). The acute toxicity of flutolanil technical is summarized in Appendix A: Table A.3 and the toxicity profile of flutolanil is shown in Appendix A: Table A.4.

		<IP_ADDRESS>	 Studies considered

Subchronic: 21-day dermal toxicity (rat), 90-day oral toxicity (rat, dog)

Developmental:  rat and rabbit developmental toxicity studies

Reproduction: two-generation reproduction study (rat)

Chronic:  oral chronic toxicity (dog), combined chronic toxicity/carcinogenicity (rat), carcinogenicity (mouse)

Other:  mutagenicity battery, metabolism

	3.2	Consideration of Toxicity to Children

There was no evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure or rat pups to post-natal exposure to flutolanil.  Flutolanil is not neurotoxic, and it is not a developmental or reproductive toxicant. No maternal, reproductive, or developmental toxicity was observed at the limit dose. A developmental neurotoxicity study is not required for flutolanil. Consistent with the previous assessment (1999), the FQPA safety factor for the protection of infants and children is reduced to 1X.

	3.3	Absorption, Distribution, Metabolism, Excretion (ADME)

In a metabolism study in rats (MRID No. 42606602) disposition and metabolism of 14C-flutolanil was investigated at a low oral dose of 20 mg/kg, repeated low oral doses of 20 mg/kg for 14 days, and a single high dose of 1000 mg/kg.  Absorption of flutolanil was incomplete at the single low and high doses but appeared to be increased after repeated low oral dosing.  There were no appreciable tissue levels of flutolanil at study termination (168 hours post-dose).  At the single low oral dose, excretion in urine and feces was equivalent, with approximately 40% of an administered dose excreted via each route in male and female rats.  Repeated low dosing resulted in an increased percentage of radioactive flutolanil in urine (approximately 70%) with a corresponding decrease in fecal excretion (10% of dose).  At the single high dose, the majority of radioactivity (66-78%) was excreted via the feces, with less than 10% found in urine.  Identification of urinary and fecal metabolites by TLC showed the presence of a major metabolite (M-4) in urine, N-(3'-hydroxyphenyl)-2-(trifluoromethyl)benzamide, in all dose groups.  In feces, radioactivity was excreted mainly as parent chemical, with limited conversion to M-4.

	3.4	Hazard Identification and Toxicity Endpoint Selection  TC \l2 "3.5 Hazard Identification and Toxicity Endpoint Selection

The toxicity endpoints and doses for risk assessment were selected based upon the available toxicity data and the use exposure information on flutolanil. The selected endpoints and doses are presented below.

		3.4.1	Acute Reference Dose (aRfD) - Females age 13-49

No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies for females 13+. This risk assessment is not required.

		3.4.2	Acute Reference Dose (aRfD) - General Population

No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies for the general population. Since repeat oral exposure at or greater than the limit dose does not result in neurotoxicity, there is no need for an acute neurotoxicity study.

		3.4.3	Chronic Reference Dose (cRfD)

HED selected a chronic PAD of 0.50 mg/kg/day (NOAEL = 50 mg/kg/day; Uncertainty Factor = 100) based on a chronic oral toxicity study in dogs.  In this study, the NOAEL of  50 mg/kg/day was based on an increased incidence of clinical signs of toxicity (emesis, salivation, and soft stool) observed from the 65th week at the systemic LOAEL of 250 mg/kg/day.  The Uncertainty Factor accounts for both interspecies extrapolation (10X) and intraspecies variability (10X)(See Appendix A., Guideline §870.4100).

		3.4.4	Incidental Oral Exposure (Short -Term)

No appropriate endpoint attributable to a short duration of exposure was identified from the database.

		3.4.5	Incidental Oral Exposure (Intermediate-Term)

No appropriate endpoint attributable to a 6-month duration of exposure was identified from the database

		3.4.6	Dermal Absorption

There are no dermal absorption data on flutolanil.  A 21-day dermal toxicity study in rats was performed at 1000 mg/kg/day (limit dose). No dermal or systemic effects were observed.  Oral exposure at the limit dose also shows no effects.

		3.4.7	Dermal Exposure (Short-, Intermediate- and Long-Term)

In a 21 day dermal toxicity study in rats, no toxic effects were observed in studies in which flutolanil was administered by the dermal route of exposure at the limit dose (1000 mg/kg/day).  Further, there is no developmental or reproductive concern at dose levels that do not exceed the limit dose.  For these reasons, it is concluded that no short-term, intermediate-term, or long-term dermal risk assessment is required (see Appendix A.2, Guideline §870.320).

		3.4.8	Inhalation Exposure (Short- and Intermediate-Term)

No appropriate endpoint was identified in the database for these durations of exposure. Although there is no route-specific study available on flutolanil, the available data indicate that flutolanil is not very toxic via either the oral or dermal routes of exposure; e. g., adverse effects observed only following dose levels at or close to the limit dose and only following chronic exposure. A subchronic inhalation toxicity study is not required at this time, based on the fact that there is minimal inhalation exposure,  flutolanil is a Toxicity Category IV (acute inhalation),  and the MOEs exceed 1000.

		3.4.9	 Inhalation Exposure (Long-Term)

The current use pattern does not indicate long-term inhalation exposure potential; therefore, this risk assessment is not required.

		3.4.10	Classification of Carcinogenic Potential

Flutolanil is classified as “not likely to be carcinogenic to humans”.  TC \l3 "3.5.10	Classification of Carcinogenic Potential

		3.4.11	Summary of Toxicological Doses and Endpoints for Use in Human

			Risk Assessments

The toxicological doses and endpoints selected for various exposure scenarios are summarized in Table 3.4.11.

Table 3.4.11	Summary of Toxicological Doses and Endpoints for Flutolanil for Use in Dietary and Non-Occupational Human Risk Assessments

Exposure

Scenario

Point of Departure

Uncertainty/

FPQA Factors

RfD, PAD, Level of Concern for Risk Assessment

Study and Toxicological Effects

 Acute Dietary

(All populations)	No appropriate toxicological endpoint attributable to a single exposure (dose) was identified from the oral toxicity studies including developmental toxicity studies in rats and rabbits.  This risk assessment is not required.

Chronic Dietary

(All populations)

NOAEL= 50 mg/kg/day

 	UFA=10X

UFH=10X

FQPA SF = 1X

	cRfD =

0.5 mg/kg/day

cPAD =

0.5 mg/kg/day	2-year Chronic study in dogs.

MRID no. 40342922

LOAEL = 250 mg/kg/day based on increased incidence  of clinical toxic signs (emesis, salivation, and soft stool)

Incidental Oral Short- and intermediate-Terms 	No appropriate endpoint was identified in the database for these durations of exposure.

Dermal

 (all durations)	No appropriate endpoint was identified in the database for this route of exposure.

Inhalation

 Short- and Intermediate-Terms	No appropriate endpoint was identified in the database for these durations of exposure.

Long-term inhalation 	The current use pattern does not indicate long-term inhalation exposure potential.

Cancer (oral, dermal, inhalation)

Classification:  “Not likely to be Carcinogenic to Humans” based on the absence of significant tumor increases in two adequate rodent carcinogenicity studies.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.  PAD = Population adjusted dose

	3.5	Endocrine Disruption

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.”  Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife.  For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.  As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

When additional appropriate screening and/or testing protocols being considered under the Agency’s EDSP have been developed, flutolanil may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption.

4.0	DIETARY EXPOSURE/RISK CHARACTERIZATION tc "5.0	Dietary Exposure/Risk Characterization"

	4.1	Pesticide Metabolism and Environmental Degradation  tc "5.1  Pesticide Metabolism and Environmental Degradation " \l 2

		4.1.1	Metabolism in Primary Crops and Livestock tc "5.1.1	Metabolism in Primary Crops " \l 3

No plant or livestock metabolism data were submitted with the subject petitions.  It has been previously concluded that the nature of the residue in plants is adequately understood based on acceptable metabolism studies in rice, cucumber leaves, and peanuts.  Flutolanil and its metabolite M-4 ( N-(3'-hydroxyphenyl)-2-(trifluoromethyl)benzamide) were the major residue components in plants.  The metabolites in the rotational crops were similar to those in primary crops.  The major residue components were flutolanil and metabolites M-4 and M-5 (N-[3',4'-(dihydroxy)phenyl]-2- (trifluoromethyl)benzamide).  The residues of concern for tolerance expression and dietary risk assessment for rotational crops are flutolanil and metabolites containing the common moiety, 2-trifluoromethyl benzanilide.

The nature of the residue in livestock is adequately understood based on acceptable metabolism studies in goats and poultry.  HED previously concluded that the residues of concern for tolerance expression and dietary risk assessment in livestock commodities are flutolanil and metabolites M-2 (N-[4'-hydroxy-3'-(1-methylethoxy)phenyl]-2-(trifluoromethyl) benzamide), M-4, and M-7 (N-(4'-hydroxy-3'-methoxy)phenyl -2-(trifluoromethyl)benzamide) in animal tissues, and the glucuronide/sulfate conjugates of M-4 in milk.  As the petitioner has proposed an enforcement analytical method that determines residues of flutolanil and metabolites converted to 2-trifluoromethyl benzoic acid, tolerances will be established in terms of parent plus metabolites converted to the common moiety.

		4.1.2	Metabolism in Rotational Crops

The nature of the residue in rotational crop commodities is adequately understood based on an acceptable confined rotational crops study with lettuce, radish, and oat/sorghum conducted with [U-14C-aminophenoxy]flutolanil.  The metabolites in the rotational crops were similar to those in primary crops.  The major residue components were flutolanil and metabolites M-4 and M-5.

		4.1.3	Analytical Methodology  tc "5.1.4	Analytical Methodology " \l 3

The proposed enforcement analytical method (Method AU/95R/04) is a common moiety GC/MS method which determines residues of flutolanil and metabolites as 2-trifluoromethyl benzoic acid (2-TFBA).  The method has undergone a successful independent laboratory validation.  The Agency previously concluded that the following additional data are required to support the enforcement method AU/95R/04:  (1) additional radiovalidation data from all previously submitted metabolism studies; and (2) additional recovery data for potato.  In addition, because the method is a common moiety method, a confirmatory method was required.  These requirements do not appear to have been addressed, and the results of the petition method validation were not available.  In addition, we note that the method must be rewritten to include instructions for analysis of additional crops including potatoes and rotational crops for which tolerances are to be established.

Samples from the submitted corn and cotton rotational crop field trials and processing study were analyzed for residues of flutolanil and its metabolite M-4 using LC/MS/MS Method XAM-65.  The limit of quantitation (LOQ) was 0.05 ppm for each analyte in/on all corn and cotton matrices.  Under the current action, the petitioner has proposed Method XAM-65 as a replacement enforcement method for Method AU/95R/04.  Method XAM-65 is not acceptable as a data collection method and is not suitable as a replacement for the current enforcement analytical method because it does not determine the residues of concern in plant commodities, flutolanil and metabolites containing the common moiety, 2-trifluoromethyl benzanilide.  Samples from the soybean and wheat rotational crop field trials and processing study were analyzed by the proposed enforcement method, Method AU/95R/04.  The method was adequate for data collection based on acceptable concurrent recovery data.

Adequate multiresidue method testing data for flutolanil and metabolite M-4 were submitted in conjunction with petitions for an experimental use permit on rice (PP#3G4184/PP#3H5658).  Both analytes were tested through Protocol I (corresponding to current Protocols C, E, and F) and Protocol III (corresponding to Protocol D).  Because neither flutolanil nor M-4 was recovered through the Florisil column, no further testing was conducted under Protocol I.  Under Protocol III (a.k.a. D), recoveries of flutolanil were 90.2% and 90.9% at fortifications of 0.05 and 0.5 ppm, and recoveries of M-4 were 68.4% and 88.2% for M-4 at the same fortification levels; neither analyte was recovered from spiked rice samples at 0.05 ppm.  The multiresidue test results were forwarded to FDA.

		4.1.4	Drinking Water Residue Profile  tc "5.1.8	Drinking Water Residue Profile " \l 3

There are no established Maximum Contaminant Level for residues of flutolanil in drinking water.  No health advisory levels for flutolanil in drinking water have been established.

EFED does not have monitoring data available to perform a quantitative drinking water risk assessment for flutolanil at this time.  Ground and surface water exposure estimates for use of flutolanil on rice were provided by EFED (Memo from S. Abel, 12/13/1999).   Therefore, the Agency is presently relying on computer-generated estimated environmental concentrations (EECs).  For any given pesticide, the SCI-GROW model generates a single EEC value of pesticide concentration in ground water.  SCI-GROW is an empirical model based upon actual monitoring data collected for a number of pesticides that serve as benchmarks.  SCI-GROW is used to predict EECs in  ground water.  The first approximation model generates a single mean concentration in surface water for the rice paddy in the paddy water for an acute assessment and pond water for the chronic assessment.  These models take into account the use patterns and the environmental profile of a pesticide, but do not consider processing of raw water for distribution as drinking water.  The primary use of these models by the Agency at this stage is to provide a coarse screen for assessing whether a pesticide is likely to be present in drinking water at concentrations which would exceed human health levels of concern.

For this risk assessment, the first approximation rice model was used to estimate EECs in surface water.  The first approximation model is an interim pesticide fate and transport model to account for the direct application of pesticides to rice paddy water.  Fundamental transformation processes (e.g., hydrolysis, metabolism, and photolysis) are not incorporated into the model.  However, the partitioning between the water and sediment/organic material fractions are accounted for using a set of mathematical algorithms both in the paddy water for an acute assessment and pond water for the chronic assessment.  Paddy water depth is assumed to be 4 inches with a field size of 1 hectare and the sediment-water interaction zone is 5 cm. Equilibrium is assumed to be instantaneous between the water-sediment faction.  The release of the paddy water is to the standard farm pond ( 1 hectare, 2 meters deep) with subsequent partitioning between the water-sediment factions.

Metabolism studies in water showed that flutolanil is resistant to all modes of abiotic and biotic degradation. The residues in water are the parent compound and M4; and the parent is the major residue. The MARC concluded that only the parent needs be included in the drinking water exposure assessment for flutolanil.   EFED conducted its Tier I screening-level assessments using the simulation models SCI-GROW and first approximation rice model to generate EECs for ground and surface water, respectively.  The modeling was conducted based on the environmental profile and the maximum seasonal application rate proposed for flutolanil (0.5 lb ai/A x 2 applications/A/year on rice).  The first approximation rice model was used to account for the direct application of pesticides to rice paddy water.  The EECs are shown in Table 10.

	Table <IP_ADDRESS>:  EFED Estimated Environmental Concentrations (EECs)

	SCI-GROW1   (µg/L)2

First Approximation Model 3   (µg/L) 2

	0.34   (acute & chronic)

	3.75(Mean, Chronic)

1	SCI-GROW (Screening Concentration in Ground Water) is an empirical model for predicting pesticide levels in ground water.  The value from SCI-GROW is considered an upper bound concentration estimate.

2	µg/L  = parts per billion.

3	First approximation model is an interim pesticide fate and transport model to account for the direct application of pesticides to rice pond water.

		4.1.5	Food Residue Profile

PP#0F6159.   The field rotational crop studies with soybeans and wheat are adequate and are geographically representative of major production regions of the primary crop peanuts.  Samples of treated soybean and wheat RACs and processed commodities were stored frozen for approximately 3 years from sampling until completion of the residue analyses.  Supporting storage stability data are available indicating that flutolanil residues are stable for (3 years in/on peanut commodities

Soybean.  For soybeans planted 30 days following a soil application of flutolanil (70% WP) at 2.0 lb ai/A (the 1x rate for peanuts), flutolanil-derived residues were <0.05-7.4 ppm in/on soybean forage, <0.05-1.5 ppm in/on soybean hay, and 0.10 ppm in soybean seed.  These data support the proposed tolerances.  The soybean processing study was conducted using seed from the NC test (1x).  Residues were <0.05 ppm in soybean seed and hulls, meal, and refined oil, indicating that tolerances for inadvertent residues of flutolanil are not required for soybean processed commodities.

Wheat.  For wheat planted 30 days following a soil application of flutolanil (70% WP) at 2.0 lb ai/A (the 1x rate for peanuts), flutolanil-derived residues were <0.05-1.6 ppm in/on wheat forage, <0.05-0.47 ppm in/on wheat hay, <0.05 ppm in wheat grain, and <0.05-0.16 ppm in wheat straw.  These data support the proposed tolerances.  The wheat processing study was conducted using grain from the OK test (1x).  Residues were <0.05 ppm in wheat grain, germ, middlings, shorts, and flour, and averaged 0.16 ppm in bran.  These data indicate that a tolerance of 0.2 ppm would be appropriate for inadvertent residues in wheat bran.

PP#6F7070.  Data depicting residues in corn ad cotton rotational crops are classified as scientifically unacceptable.  Samples of corn and cotton matrices were stored frozen for 7.5-8 years from harvest to analysis.  Storage stability data are not available to support the storage durations of the samples from the rotational crop field study.

Corn.  Residues of flutolanil and M-4 were each below the LOQ (<0.05 ppm) in/on all samples of rotated corn forage and grain. Maximum residues of flutolanil and M-4 were 0.051 and 0.084 ppm, respectively, for maximum combined residues of 0.134 ppm in corn fodder. In the corn processing study, residues of flutolanil and M-4 were each below the method LOQ (<0.05 ppm) in corn grain (RAC), processed corn starch, crude oil, refined oil, grits (small, medium & large), coarse meal, meal, and flour.   Because residues were below the LOQ in both the RAC and processed commodities, processing factors could not be calculated.  No conclusions concerning the concentration of residues in the processed commodities of rotated corn can be made.

Cotton.  Residues of flutolanil and M-4 were each below the LOQ (<0.05 ppm) in/on all samples of rotated cotton seed, seed lint, ginned seed, and gin byproducts.  Residues of flutolanil and M-4 were each below the method LOQ (<0.05 ppm) in cotton seed (RAC) and processed cotton hulls, meal, crude oil, and refined oil.  Because residues were below the LOQ in both the RAC and processed commodities, processing factors could not be calculated.  No conclusions concerning the concentration of residues in the processed commodities of rotated cotton can be made.

		4.1.6	International Residue Limits  tc "5.2.10	International Residue Limits " \l 3

Codex maximum residue limits (MRLs) are established for residues of flutolanil per se in rice commodities at 1-10 ppm, and in livestock commodities at 0.05-0.2 ppm.  No Canadian or Mexican MRLs have been established.

	4.2	Dietary Exposure and Risk  tc "5.2  Dietary Exposure and Risk " \l 2

A chronic dietary exposure assessment (using tolerance-level residues and assuming all crops are treated (100 %CT)) , and was conducted for the general U.S. population and various population subgroups.  Exposure to drinking water was incorporated directly into the dietary assessment using the chronic (annual average) concentration for surface water generated by the first approximation rice model.  This assessment concludes that the chronic dietary exposure estimates are below HED’s level of concern (<100% cPAD) for the general U.S. population and all population subgroups.  The chronic dietary exposure is estimated for the U.S. population at <1% of the cPAD and the most highly exposed population subgroup, infants (<1 year old), at 1% of the cPAD.

Table 4.2.1:  Results of the Chronic Dietary Risk Analysis

Population Subgroup	Chronic Dietary

	Dietary Exposure

(mg/kg/day)	% cPAD*

General U.S. Population	0.002607	<1

All Infants (< 1 year old)	0.005965	1.2

Children 1-2 years old	0.005369	1.1

Children 3-5 years old	0.004834	1.0

Children 6-12 years old	0.003358	<1

Youth 13-19 years old	0.002420	<1

Adults 20-49 years old	0.002490	<1

Adults 50+ years old	0.001640	<1

Females 13-49 years old	0.002083	<1

5.0	RESIDENTIAL (NON-OCCUPATIONAL) EXPOSURE AND RISK

There are non-occupational uses associated with flutolanil.  Non-occupational handlers may mix, load and apply flutolanil products to turf grass.  Although residential (non-occupational) exposure exists, an assessment was not conducted since no toxicological endpoint attributable to short- or intermediate-term route of exposure have been identified and the current use pattern does not indicate long-term exposure (6 or more months of continuous exposure) potential.

6  SEQ CHAPTER \h \r 1 .0	Aggregate Risk Assessments and Risk Characterization

In accordance with the FQPA, the Agency must consider aggregate pesticide exposures and risks from three major sources: food, drinking water, and residential exposures.  In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated.  When aggregating exposures and risks from various sources, the Agency considers both the route and duration of exposure.  In the case of flutolanil, aggregate risk assessments were performed for chronic aggregate exposure (food + drinking water) only.  Short-, and intermediate-term aggregate risk assessments were not performed because toxicity form dermal and inhalation exposure was not identified.  Additionally, the Agency does not expect residential exposure durations that would result in long term exposures.  A cancer aggregate risk assessment was also not performed because flutolanil is not carcinogenic.

The chronic aggregate risk assessment takes into account average exposure estimates from dietary consumption of flutolanil (food and drinking water) and residential uses.  However, due to the use patterns, no hazard from chronic residential exposures is expected.  Therefore, the chronic aggregate risk assessment will consider exposure from food and drinking water only.  The chronic dietary exposure estimates for food and drinking water are below HED’s level of concern (<100% cPAD) for the general U.S. population (1% of the cPAD) and all population subgroups (≤ 1).  Therefore, the chronic aggregate risk associated with the proposed and registered uses of flutolanil does not exceed HED’s level of concern for the general U.S. population or any population subgroups.

7  SEQ CHAPTER \h \r 1 .0	Cumulative Risk Characterization/Assessment

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to flutolanil and any other substances and flutolanil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that flutolanil has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at   HYPERLINK "http://www.epa.gov/pesticides/cumulative/._"  http://www.epa.gov/pesticides/cumulative/.

8.0	Occupational Exposure/Risk Pathway

Workers may be exposed to flutolanil during mixing, loading, application, and postapplication activities.   Based on the proposed application rates and use scenarios, short- and intermediate-term occupational exposures may occur.  However, since short-and intermediate-term endpoints have not been established, an occupational exposure assessment is not required.

Chronic occupational exposure is not expected; thus, chronic occupational exposure risk assessments are also not required.

9.0	DATA NEEDS/LABEL REQUIREMENTS

Analytical reference standards of flutolanil and its metabolites must be supplied and supplies replenished as requested by the Repository.  For the expired reference standards, the petitioner must either recertify the lot in the repository and send in an updated certificate of analysis (COA), or submit new standards (different lot #) if the previous lots will not be recertified.  If new COAs are being submitted, they should be faxed to the repository at<PHONE_NUMBER>.

The Agency previously concluded that the following additional data are required to support the enforcement method AU/95R/04:  (1) additional radiovalidation data from all previously submitted metabolism studies; and (2) additional recovery data for potato.  In addition, because the method is a common moiety method, a confirmatory method was required that is able to confirm the identity and amount of all residues of concern. These requirements do not appear to have been addressed, and the results of the petition method validation were not available.  In addition, we note that the method must be rewritten to include instructions for analysis of additional crops including potatoes and rotational crops for which tolerances are to be established.

Data deficiencies pertaining to rotated corn and cotton need be addressed only if the petitioner intends to pursue reduced PBIs for these commodities.

10.0 	REFERENCES

DP#:	None

Subject:	Flutolanil.  HED Metabolism Assessment Review Committee (MARC) Meeting Held on 12-16-99.  PC Code 128975

From:	M. Xue

To:	G. Kramer

Date:	1/6/00

MRIDs:			None

DP#:	267571

Subject:	PP#6F04693/PP#6H05749, Flutolanil in/on Potatoes and Rice.  Evaluation of Independent Laboratory Validation Data.

From:	W. Wassell

To:	M. Waller

Date:	7/21/00

MRIDs:			44537601

DP#:	267801

Subject:	Flutolanil.  PP#0F06159:  Evaluation of Residue Chemistry Data to Support Permanent Tolerances for Indirect or Inadvertent Residues in Rotated Crops

From:	M. Xue

To:	L. Jones/M. Waller

Date:	11/28/01

MRIDs:	45104001

DP#:	334156 & 335050

Subject:	Flutolanil.:  Petitions for Establishment of Tolerances for Indirect or Inadvertent Residues in/on Corn, Cotton, Soybean, and Wheat Commodities.  Summary of Analytical Chemistry and Residue Data

From:	F. Fort

To:	L. Jones/M. Waller

Date:	11/19/07

MRIDs:	46790801-4670803

DP#:	268880

Subject:	PP#6F4693 and PP#4F04380  Flutolanil on Rice and Potato: Human Health Risk Assessment

From:	A. Lowit

To:	L. Jones

Date:	09/11/00

MRIDs:			None

Appendix A:  Executive Summaries

A.1     Chronic oral toxicity study– dog

In a chronic oral toxicity study (MRID 40342922), flutolanil (97.5-99.8% a.i., Lot No. NNF-136) was administered orally, by gelatin capsule, to 6 male and female beagle dogs/group at dose levels of 0, 50, 250, and 1250 mg/kg/day for 2-years.

All dogs survived until study termination.  No treatment-related changes in ophthalmoscopic, hematological, clinical chemistry, organ weights, gross pathology, or histopathology parameters were observed in either sex.  Following 65 weeks of exposure, there was a dose-related increase in the incidence of clinical signs (emesis, salivation, and soft stool) in both sexes at 250 and 1250 mg/kg/day, which continued until study termination.  In addition, at 1250 mg/kg/day, decreased body weight gains (from the 82nd week in males and from the 81st week in females) and decreased food consumption (from the 79th week in males and from the 74th week in females) were observed.  The LOAEL was 250 mg/kg/day based on increased incidence of clinical toxic signs (emesis, salivation, and soft stool).  The NOAEL was 50 mg/kg/day.

This chronic study in dogs is classified acceptable (guideline), and it satisfies the guideline requirement (870.4100b) for a chronic oral toxicity study in a nonrodent.

A.2       21-Day dermal toxicity study – rat

In a 21-day dermal toxicity study (MRID 41841205), flutolanil (97.6 % a.i., Lot No. 543251) in distilled water was administered dermally to 5 male and 5 female CD rats/group in 15 applications (6 hours/day, 5 days/week) over a 21-day interval at doses of 0 (vehicle control) or 1000 mg/kg/day (limit dose). No treatment-related changes in clinical observations, dermal effects, body weights, food consumption, hematology, clinical chemistry, organ weights, gross pathology or histopathology parameters were observed.  The NOAEL for systemic toxicity or dermal irritation was 1000 mg/kg/day (limit dose) and a LOAEL was not established for systemic toxicity or dermal irritation.

This dermal study is classified acceptable (guideline), and it satisfies the guideline requirement (870.3200) for the repeat dose dermal toxicity study.

Table A.3.  Acute Toxicity of Flutolanil Technical1

GDLN

Study Type

MRID nos.

Results

Tox Category

§81-1

Acute Oral

40342905

LD50 > 10,000 mg/kg

IV

§81-2

Acute Dermal

40342906

LD50 > 2,000 mg/kg

III

§81-3

Acute Inhalation

40342910

LC50 > 5.98 mg/L (4 hours)

IV

§81-4

Primary Eye  Irritation

40342912

Minimal irritation

IV

§81-5

Primary Skin Irritation

40342915

Not a dermal irritant

IV

§81-6

Dermal Sensitization

40342917

Not a dermal sensitizer

N/A

	1  All studies were conducted on technical grade flutolanil, 98% purity.

Table A.4. Toxicity Profile of Flutolanil Technical

Guideline No./ Study Type

MRID No. (year)/ Classification /Doses

Results

870.3100 (82-1)

90-day Oral Toxicity Rat - diet

40342919 (1986)/

Acceptable-Guideline/

0, 500, 4000, 20000 ppm (M: 0, 37, 299, 1512 mg/kg/d; F: 0, 44, 339, 1743 mg/kg/d)

NOAEL = 1512 mg/kg/day (HDT),

LOAEL =  not established

At 1512  mg/kg/day (HDT): increased absolute liver weights (males),  increased relative liver weights (males and females), slight decrease in body weights (males) and slight increases in absolute and relative thyroid/parathyroid weights were observed.  No treatment-related changes in ophthalmoscopic, hematological, clinical chemistry, gross pathology, or histopathology parameters were observed.  Therefore, the increased liver weights are considered to be an adaptive response to flutolanil treatment.

870.3150 (82-1)

90-day Oral Toxicity In Nonrodents (Dog) - gelatin capsule

40342920 (1986)/ Acceptable-Guideline/ 0, 80, 400, 2000 mg/kg/d

NOAEL = 80 mg/kg/day,

LOAEL = 400 mg/kg/day based on enlarged livers and increased severity of hepatic glycogen deposition in both males and females.

At 2000 mg/kg/day (HDT), an elevation in alkaline phosphatase and cholesterol levels and slight increases in absolute and relative thyroid/parathyroid weights were observed

870.3200 (82-2)

21-day Dermal Toxicity - Rat

41841205 (1991)/ Acceptable-Guideline/ 0, 1000 mg/kg/d

Systemic NOAEL=  1000 mg/kg/day (limit dose),

Systemic LOAEL > 1000 mg/kg/day.

Dermal irritation NOAEL=  1000 mg/kg/day (limit dose),

Dermal irritation > 1000 mg/kg/day.

870.3250

90-day Dermal Toxicity

Not available

Not available

870.3465

90-day Inhalation Toxicity

Not available

Not available

870.3700a(83-3a)

Prenatal Developmental In Rat - oral gavage

41850804(1987)/ Acceptable-Guideline/0, 40, 200, 1000 mg/kg/d

Maternal NOAEL = 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day,

Developmental NOAEL= 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day.

870.3700b(83-3b)

Prenatal Developmental In Rabbit - oral gavage

40342924(1987)/ Acceptable-Guideline/ 0,40,200,1000 mg/kg/d

Maternal NOAEL= 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day,

Developmental NOAEL = 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day.

870.3800(83-4)

Reproduction And Fertility Effects In Rat - 2 Generation - diet

41850805(1992)/ Acceptable-Guideline/ 0,200,2000,20000 ppm

(M: 0,16,159,1625 mg/kg/d;

F: 0,19,190,1936 mg/kg/d)

Parental/Systemic NOAEL = 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day,

Reproductive NOAEL = 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day.

Offspring NOAEL = 1000 mg/kg/day,

LOAEL > 1000 mg/kg/day.

870.3800(83-4)

Reproduction And Fertility Effects In Rat - 3 Generation - diet

40342923(1982)/ Unacceptable/ 0, 1000, 10000 ppm (M: 0, 63, 661 mg/kg/d; F: 0, 86, 880 mg/kg/d)

Parental/Systemic NOAEL = 661 mg/kg/day,

LOAEL > 661 mg/kg/day,

Reproductive NOAEL = 661 mg/kg/day,

LOAEL > 661 mg/kg/day.

870.4100a

Chronic Toxicity Rodents

See combined chronic / carcinogenicity study available (see below)

870.4100b (83-1)

Chronic Toxicity Dogs- gelatin capsule

40342922(1982)/ Acceptable-Guideline/ 0, 50, 250, 1250 mg/kg/d

NOAEL = 50 mg/kg/day,

LOAEL = 250 mg/kg/day based on increased incidence of clinical toxic signs (emesis, salivation, and soft stool) observed from the 65th week.

At 1250 mg/kg/day (HDT), increased incidence of clinical toxic signs (from the 65th week), decreased body weight gains (from 82nd week in males and from 81st week in females) and decreased food consumption (from 79th week in males and from 74th week in females) were observed.

No treatment-related changes in ophthalmoscopic, hematological, clinical chemistry, organ weights, gross pathology, or histopathology parameters were observed.

870.4100a & 870.4200

 (83-1 & 83-5)

Chronic/ Oncogenicity Rats - diet

40342921 (1982)/ Acceptable-Guideline/

0, 40, 200, 2000, 10000 ppm

(M: 0, 2, 9, 87, 460 mg/kg/d F: 0, 2, 10, 103, 536 mg/kg/d)

NOAEL = 460 mg/kg/day,

LOAEL = not established

At 460 mg/kg/day (HDT), increased absolute and relative liver weights (males and females) were observed in the absence of clinical chemistry or histopathology findings.  Therefore, the increased liver weights are considered to be an adaptive response to flutolanil treatment.

870.4300(83-2)

Carcinogenicity Mice - diet

41850803(1990)/ Acceptable-Guideline/ 0, 300, 1500, 7000, 30000 ppm (M: 0,32,162,735,3333 mg/kg/d; F: 0, 34, 168, 839, 3676 mg/kg/d)

NOAEL = 735 (M) and 168 (F) mg/kg/day,

LOAEL = 3333 (M) and 839 (F) mg/kg/day based on decreased body weight gains.

Gene Mutation

870.5375 (84-2), In vitro Chromosomal Aberration Assay in Cultured Mammalian Cell

40342925(1986)/ Acceptable-Guideline/0, 37, 75, 150 uM/plate

Positive finding, flutolanil induced chromosomal aberrations in cultured Chinese hamster lung cells in the presence of metabolic activation (S9).

Gene Mutation  870.5100 (84-2), Reverse Mutation Assay

40342926(1981)/  Acceptable-Guideline/0, 10, 50, 100, 500, 1000, 5000, 10000, 25000 ug/plate.

Negative (with and without S-9 metabolic activator) at doses up to 25 mg/plate in the increase in revertant colonies using Salmonella strains TA98, TA10, TA1535, TA1537, and TA1538 and in the E. Coli WP2 uvrA strain.

Gene Mutation  870.5375 (84-2), Gene Mutation in Cultured Mammalian Cells (Mouse Lymphoma Cells)

41841207(1989)/ Acceptable-Guideline/0,  6, 15, 30, 60, 80, 100 ug/mL.

Negative (either in the presence or absence of S9 activation) for the induction of forward mutations at the TK+/- locus in L5178Y mouse lymphoma cells.

Cytogenetics

870.5395 (84-2), Mouse Micronucleus

40342927(1983)/ Acceptable-Guideline/0, 6400, 8000, 10000 mg/kg either in a single dose or 10 gm/kg/day over 4 days by gastric intubation to BDF1 mice (6/sex/group).

Negative up to a dose of 10000 mg/kg in the induction of micronuclei in the bone marrow erythrocytes of male and female mice.

Cytogenetics  870.5385 (84-2), Mammalian Cells in Culture Cytogenetics Assay in Human Lymphocytes

42606628(1990)/ Acceptable-Guideline/0, 120, 250, 500, 1000 ug/mL.

Negative in the structural chromosome assay.  There was no significant increase in the frequency of aberrations with any treatment levels, either with or without activation.

Other Genotoxicity Effects  84-2,  In Vitro Unscheduled DNA Synthesis Assays in Primary Rat Hepatocytes

41841206(1989)/ Acceptable- Nonguideline/0,  2.67, 27, 53, 80 ug/mL.

  hò&

  hò&

Ôð hò&

  hò&

  hò&

  hò&

  hò&

  hò&

 hò&

& hò&

ਁ氃愀϶ل瑹⛲

ਁ氃愀϶ل瑹⛲

ༀꂄᄅ悄ㇺ$葞֠葠褐摧枳å

ਁ氃愀϶ل瑹⛲

I

J

-

2

3

8

H

J

 hò&

# hò&

# hò&

 hò&

 hò&

 hò&

  hò&

  hò&

  hò&

 hò&

  hò&

  hò&

 hò&

  hò&

  hò&

  hò&

  hò&

 hò&

 hò&

  hò&

  hò&

摧㕍?

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

 hò&

 hò&

 hò&

# hò&

# hò&

  hò&

 hò&

 hò&

  hò&

  hò&

  hò&

 hò&

 hò&

  hò&

  hò&

  hò&

 hò&

 hò&

 hò&

 hò&

  hò&

  hò&

 hò&

 hò&

 hò&

  hò&

  hò&

# hò&

愀Ĥ摧ࠫ[

 hò&

 hò&

 hò&

  hò&

  hò&

  hò&

# hò&

# hò&

# hò&

  hò&

 hò&

 hò&

 hò&

 hò&

 hò&

 hò&

  hò&

 hò&

Ȧ脈栕⛲

栕⛲

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

  hò&

 hò&

 hò&

 hò&

 hò&

 hò&

 hò&

  hò&

  hò&

 hò&

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

혈Fᴃ䀀鰋괘$⌆

将

옍

 hò&

  hò&

  hò&

ȗ脈栕⛲

栕⛲

 hò&

  hò&

 hò&

 hò&

 hò&

 hò&

 hò&

  hò&

 hò&

 hò&

ȗ脈栕⛲

栕⛲

 hò&

" hò&

 hò&

  hò&

 hò&

  hò&

 hò&

 hò&

 hò&

  hò&

 hò&

 hò&

 hò&

 hò&

 hò&

䡮В䡴Вȗ脈栕⛲

栕⛲

గܪ栕⛲

ఢܪ栕⛲

ᔟദᘀ꽨ࠀ䌀ᙊ愀ᙊ渀ቈ漄Ĩ䡴Вఝܪ栕⛲

\

摧ࠫ[

摧ࠫ[

 hò&

ఢܪ栕⛲

గܪ栕⛲

摧ࠫ[

Ȧ脈栕⛲

Ƞ脈栕⛲

栕⛲

# hò&

# hò&

  hò&

  hò&

  hò&

 hò&

 hò&

" hò&

 hò&

# hò&

  hò&

hŠ

  hò&

  hò&

Ȧ脈栕⛲

栕⛲

옍)

# hò&

# hò&

  hò&

  hò&

  hò&

hŠ

  hò&

Ȧ脈栕⛲

栕⛲

 hò&

 hò&

  hò&

 hò&

  hò&

Ȧ脈栕⛲

Ȧ脈栕⛲

栕⛲

옍)

$̀Ĥ옍)

  hò&

  hò&

 hò&

  hò&

# hò&

# hò&

# hò&

# hò&

  hò&

  hò&

 hò&

 hò&

  hò&

옍)

옍)

$

# hò&

# hò&

# hò&

# hò&

  hò&

 hò&

  hò&

 hò&

 hò&

 hò&

  hò&

  hò&

³ð hò&

栕⛲

Ȧ脈栕⛲

Ȧ脈栕⛲

栕⛲

 hò&

  hò&

 hò&

B*

  hò&

B*

栕⛲

Ȧ脈栕⛲

  hò&

  hò&

  hò&

  hò&

  hò&

  hò&

 hò&

 hò&

 hò&

  hò&

 hò&

&

&

&

&

&

혈0ἂ쐃琎ꔆ

혈Fἃ쐃鼎琙•ꔆ

&

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

&

&

혈Fἃ쐃鼎琙"ꔆ

혈Fἃ쐃鼎琙"ꔆ

  hò&

  hò&

  hò&

 hò&

 hò&

 hò&

 hò&

# hò&

 hò&

 hò&

 hò&

  hò&

  hò&

  hò&

# hò&

 hò&

 hò&

 hò&

 hò&

  hò&

  hò&

  hò&

  hò&

  hò&

# hò&

 hò&

  hò&

# hò&

# hò&

# hò&

  hò&

 hò&

 hò&

 hò&

 hò&

  hò&

+ hò&

  hò&

 hò&

 hò&

  hò&

# hò&

  hò&

  hò&

  hò&

# hò&

# hò&

瀁耈萏ࡰ萑葞ࡰ葠摧ห

瀁耈摧ห

摧ห

瀁耈萏ࡰ萑葞ࡰ葠摧ห

瀁耈摧ห

摧ห

 hò&

 hò&

 hò&

  hò&

 hò&

 hò&

" hò&

 hò&

h=

 hò&

 hò&

h=

  hò&

h=

 hò&

h=

 hò&

h=

 hò&

 hò&

  hò&

 hò&

h=

 hò&

h=

 hò&

h=

 hò&

 hò&

h=

 hò&

h=

  hò&

h=

 hò&

h=

kd

 hò&

h=

 hò&

h=

 hò&

h=

 hò&

h=

  hò&

h=

 hò&

h=

摧ᾴZ܀Negative in the induction of unscheduled DNA synthesis in primary rat hepatocytes.

870.6200a

Acute Neurotoxicity Screening Battery

Not available

Not available

870.6200b

Subchronic Neurotoxicity Screening Battery

Not available

Not available

870.6300

Developmental Neurotoxicity

Not available

Not available

870.7485

Metabolism And Pharmacokinetics -Rat

42606602(1992)/ Acceptable-Guideline/ single oral dose of 20 and 1000 mg/kg and

repeated oral doses of 20 mg/kg for 14 days

No appreciable tissue levels of flutolanil at study termination (168 hours post-dose).

20 mg/kg: urine (40%) and feces (40% of dose).

Repeated dose of 20 mg/kg: urine (70%) and feces (10%)

1000 mg/kg: urine (10%) and feces (66-78%)

Urinary metabolite by TLC:   M-4 [N-(3'-hydroxyphenyl)-2-(trifluoromethyl)   benzamide]

Fecal metabolite by TLC:  Mainly parent chemical with limited conversion to M-4.

870.7600

Dermal penetration - Rat

Not available

Not available

Special Studies

Not available

Not available

Appendix B:  Chemical Structures

APPENDIX B.	Chemical Names and Structures of Flutolanil and Metabolites.

Common name;

Company code	Chemical name	Chemical structure

Flutolanil; M1 N-[3'-(1-methylethoxy)phenyl]-2-(trifluoromethyl)benzamide

M-2 	N-[4'-hydroxy-3'-(1-methylethoxy)phenyl]-2-(trifluoromethyl) benzamide

M-3 	N-[3'-(2-hydroxy-1-methylethoxy) phenyl]-2-(trifluoromethyl)benzamide

M-4 	N-(3'-hydroxyphenyl)-2-(trifluoromethyl)benzamide

M-5 	N-[3',4'-(dihydroxy)phenyl]-2- (trifluoromethyl) benzamide

M-6 	N-(3'-methoxy)phenyl -2-(trifluoromethyl)benzamide

M-7 	N-(4'-hydroxy-3'-methoxy)phenyl -2-(trifluoromethyl)benzamide

M-11 	2-[[3-[2-(trifluoromethyl)benzoyl]-amino]phenoxy]propanoic acid

2-TFBA: 	2-trifluoromethyl benzoate

Tolerances to be established under “(d) Indirect or inadvertent residues”:

Soybean, forage	8.0 ppm

Soybean, hay	2.5 ppm

Soybean, seed	0.20 ppm

Wheat, forage	2.5 ppm

Wheat, grain	0.05 ppm

Wheat, hay	1.2 ppm

Wheat, straw	0.20 ppm

Wheat, bran	0.20 ppm

	  PAGE  6  of   NUMPAGES  28


[Federal Register: December 12, 2006 (Volume 71, Number 238)]
[Notices]
[Page 74495]
[DOCID:fr12de06-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-95-000]

Colorado Interstate Gas Company; Notice of Fuel Reimbursement

December 5, 2006.
    Take notice that on December 1, 2006, Colorado Interstate Gas
Company (CIG) is submitting this filing pursuant to Subpart C of Part
154 of the Commission's Regulations and section 42.2 of the general
terms and conditions of its FERC Gas Tariff, First Revised Volume No. 1
in order to demonstrate that the quarterly Lost and Unaccounted-For and
Other Fuel Gas percentage remains unchanged for the quarter beginning
January 1, 2007.
    CIG states that copies of its filing have been sent to all firm
customers, interruptible customers, and affected state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time December 12, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21088 Filed 12-11-06; 8:45 am]

BILLING CODE 6717-01-P