[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70920-70928]
[FR Doc No: 2014-28077]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0309]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of applications for exemptions request for comments.

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SUMMARY: FMCSA announces receipt of applications from 63 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before December 29, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0309 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 Federal Docket Management System (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, R.N., 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:

I. 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.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 63 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by
statute.

II. Qualifications of Applicants

Andrew P. Bivens

    Mr. Bivens, 21, has had ITDM since 1998. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bivens understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bivens meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Tennessee.

Everett D. Blevins

    Mr. Blevins, 50, has had ITDM since 1994. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Blevins understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Blevins meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Kentucky.

Kevin K. Brown

    Mr. Brown, 36, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or

resulting in impaired cognitive function that occurred without warning
in the past 12 months and no recurrent (2 or more) severe hypoglycemic
episodes in the last 5 years. His endocrinologist certifies that Mr.
Brown understands diabetes management and monitoring, has stable
control of his diabetes using insulin, and is able to drive a CMV
safely. Mr. Brown meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His optometrist examined him in 2014 and certified
that he does not have diabetic retinopathy. He holds an operator's
license from Minnesota.

Kirk J. Brummeler

    Mr. Brummeler, 55, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Brummeler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Brummeler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

Travis M. Bryan

    Mr. Bryan, 31, has had ITDM since 1988. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Bryan understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bryan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Massachusetts.

Robert A. Chess

    Mr. Chess, 66, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Chess understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Chess meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

John W. Condy

    Mr. Condy, 61, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Condy understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Condy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

Kevin V. Cook

    Mr. Cook, 35, has had ITDM since 2014. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Cook understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Cook meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2014 and certified that he does not have diabetic retinopathy. He
holds an operator's license from Missouri.

Guido Criscuolo, Jr.

    Mr. Criscuolo, 61, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Criscuolo understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Criscuolo meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Connecticut.

Zachary L. Diehl

    Mr. Diehl, 23, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Diehl understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Diehl meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Illinois.

Andrea I. Dirksen

    Ms. Dirksen, 31, has had ITDM since 2013. Her endocrinologist
examined her in 2013 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Dirksen understands diabetes
management and monitoring has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Dirksen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2013 and certified that she does not have
diabetic retinopathy. She holds an operator's license from Iowa.

David D. Dowdy

    Mr. Dowdy, 53, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Dowdy understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dowdy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Illinois.

Clarice L. Dunklin

    Ms. Dunklin, 59, has had ITDM since 2013. Her endocrinologist
examined him in 2014 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Dunklin understands diabetes
management and monitoring, has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Dunklin meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
ophthalmologist examined her in 2014 and certified that she does not
have diabetic retinopathy. She holds a Class A CDL from Louisiana.

Bradley A. Eastman

    Mr. Eastman, 41, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Eastman understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Eastman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Troy A. Epps

    Mr. Epps, 42, has had ITDM since 2013. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Epps understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Epps meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2014 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Massachusetts.

Ricky L. Exler

    Mr. Exler, 56, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Exler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Exler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Florida.

Paul B. Fuerstenberg

    Mr. Fuerstenberg, 51, has had ITDM since 2003. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Fuerstenberg understands
diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Fuerstenberg
meets the requirements of the vision standard at 49 CFR 391.41(b)(10).
His optometrist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Nathan M. Gallant

    Mr. Gallant, 39, has had ITDM since 2003. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gallant understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gallant meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Texas.

Edward A. Gawrys, III

    Mr. Gawrys, 35, has had ITDM since 2011. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gawrys understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gawrys meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Pennsylvania.

Louis A. Goodenough

    Mr. Goodenough, 57, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies

that Mr. Goodenough understands diabetes management and monitoring, has
stable control of his diabetes using insulin, and is able to drive a
CMV safely. Mr. Goodenough meets the requirements of the vision
standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2014
and certified that he does not have diabetic retinopathy. He holds a
Class A CDL from Indiana.

Tyler L. Gravatt

    Mr. Gravatt, 32, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Gravatt understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gravatt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Idaho.

Randy W. Haley

    Mr. Haley, 57, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Haley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Haley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Massachusetts.

Mahindra Hardeo

    Mr. Hardeo, 33, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hardeo understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hardeo meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Ohio.

Eric B. Hemmings

    Mr. Hemmings, 49, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hemmings understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hemmings meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Texas.

Gary W. Honaker

    Mr. Honaker, 54, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Honaker understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Honaker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

David G. Horne

    Mr. Horne, 59, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Horne understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Horne meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Glenn A. Keifer

    Mr. Keifer, 51, has had ITDM since 1968. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Keifer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Keifer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from South Dakota.

Rex L. Kreutzer

    Mr. Kreutzer, 47, has had ITDM since 1993. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Kreutzer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Kreutzer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

Patrick D. Letterman

    Mr. Letterman, 56, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of

consciousness, requiring the assistance of another person, or resulting
in impaired cognitive function that occurred without warning in the
past 12 months and no recurrent (2 or more) severe hypoglycemic
episodes in the last 5 years. His endocrinologist certifies that Mr.
Letterman understands diabetes management and monitoring, has stable
control of his diabetes using insulin, and is able to drive a CMV
safely. Mr. Letterman meets the requirements of the vision standard at
49 CFR 391.41(b)(10). His optometrist examined him in 2014 and
certified that he does not have diabetic retinopathy. He holds a Class
A CDL from Missouri.

Larry D. Lloyd

    Mr. Lloyd, 63, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Lloyd understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lloyd meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Oregon.

Dennis D. Markowski

    Mr. Markowski, 59, has had ITDM since 2003. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Markowski understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Markowski meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Washington.

William F. Melchert-Dinkel

    Mr. Melchert-Dinkel, 52, has had ITDM since 2014. His
endocrinologist examined him in 2014 and certified that he has had no
severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function that occurred without warning in the past 12 months
and no recurrent (2 or more) severe hypoglycemic episodes in the last 5
years. His endocrinologist certifies that Mr. Melchert-Dinkel
understands diabetes management and monitoring, has stable control of
his diabetes using insulin, and is able to drive a CMV safely. Mr.
Melchert-Dinkel meets the requirements of the vision standard at 49 CFR
391.41(b)(10). His optometrist examined him in 2014 and certified that
he does not have diabetic retinopathy. He holds a Class A CDL from
Minnesota.

Brit K. Miller

    Mr. Miller, 28, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Miller understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Miller meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from South Dakota.

Charles B. Petersen

    Mr. Petersen, 63, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Petersen understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Petersen meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Idaho.

Basil R. Peterson, Jr.

    Mr. Peterson, 67, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Peterson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Peterson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Maine.

Travis J. Phillips

    Mr. Phillips, 24, has had ITDM since 2005. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Phillips understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Phillips meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Texas.

Anthony J. Politan

    Mr. Politan, 46, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Politan understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Politan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that

he does not have diabetic retinopathy. He holds a Class A CDL from
Indiana.

Emil T. Ricci

    Mr. Ricci, 66, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ricci understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ricci meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Pennsylvania.

Robert D. Risk

    Mr. Risk, 39, has had ITDM since 2014. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Risk understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Risk meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2014 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Indiana.

Joseph M. Ritenour

    Mr. Ritenour, 61, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Ritenour understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ritenour meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Arturo Robles

    Mr. Robles, 36, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Robles understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Robles meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Wyoming.

Robert F. Rothbauer

    Mr. Rothbauer, 53, has had ITDM since 1999. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Rothbauer understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Rothbauer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Wisconsin.

Michael A. Runyan, Jr.

    Mr. Runyan, 42, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Runyan understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Runyan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from North Carolina.

Tyler A. Russell

    Mr. Russell, 31, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Russell understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Russell meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from
Massachusetts.

John D. Sheets

    Mr. Sheets, 57, has had ITDM since 2005. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sheets understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sheets meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from New Hampshire.

Kyle L. Shuman

    Mr. Shuman, 29, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Shuman understands

diabetes management and monitoring, has stable control of his diabetes
using insulin, and is able to drive a CMV safely. Mr. Shuman meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from New York.

Thomas S. Skoczylas

    Mr. Skoczylas, 62, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Skoczylas understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Skoczylas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds an operator's license from Ohio.

Jerry W. Smay

    Mr. Smay, 63, has had ITDM since 2008. His endocrinologist examined
him in 2014 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Smay understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Smay meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2014 and certified that he has stable nonproliferative diabetic
retinopathy. He holds a Class A CDL from California.

Gregory A. Smith

    Mr. Smith, 53, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Smith understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Smith meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

Harold B. Snyder

    Mr. Snyder, 55, has had ITDM since 2010. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Snyder understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Snyder meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

William S. Spaeth

    Mr. Spaeth, 39, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Spaeth understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Spaeth meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Wisconsin.

Curtis W. Stanley

    Mr. Stanley, 61, has had ITDM since 2011. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Stanley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Stanley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Nebraska.

Eloy G. Tijerina

    Mr. Tijerina, 58, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tijerina understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tijerina meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Texas.

Santos R. Torres

    Mr. Torres, 35, has had ITDM since 2008. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Torres understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Torres meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Texas.

Leroy A. Traudt

    Mr. Traudt, 60, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting

in loss of consciousness, requiring the assistance of another person,
or resulting in impaired cognitive function that occurred without
warning in the past 12 months and no recurrent (2 or more) severe
hypoglycemic episodes in the last 5 years. His endocrinologist
certifies that Mr. Traudt understands diabetes management and
monitoring, has stable control of his diabetes using insulin, and is
able to drive a CMV safely. Mr. Traudt meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2014 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Nebraska.

Arthur R. Vance

    Mr. Vance, 57, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Vance understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Vance meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Gerald S. Volpone, Jr.

    Mr. Volpone, 53, has had ITDM since 1976. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Volpone understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Volpone meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
proliferative diabetic retinopathy. He holds a Class A CDL from
Massachusetts.

Galen R. Watts

    Mr. Watts, 58, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Watts understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Watts meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Texas.

William R. Welch, Jr.

    Mr. Welch, 66, has had ITDM since 2005. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Welch understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Welch meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Virginia.

John E. Wildenmann

    Mr. Wildenmann, 46, has had ITDM since 2009. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wildenmann understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wildenmann meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2014 and certified that he has stable
nonproliferative diabetic retinopathy. He holds an operator's license
from Kentucky.

Mark A. Wolford

    Mr. Wolford, 45, has had ITDM since 2013. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wolford understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wolford meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Pennsylvania.

Edward D. Wright

    Mr. Wright, 53, has had ITDM since 2014. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wright understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wright meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2014 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Indiana.

John P. Wysong

    Mr. Wysong, 55, has had ITDM since 2012. His endocrinologist
examined him in 2014 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wysong understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wysong meets the
requirements of the vision standard at

49 CFR 391.41(b)(10). His optometrist examined him in 2014 and
certified that he does not have diabetic retinopathy. He holds a Class
B CDL from Indiana.

III. 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. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441) \1\. The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
years of experience operating CMVs while being treated with insulin;
and (2) establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

IV. Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number FMCSA-2014-0309 and click
the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

V. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, to submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
FMCSA-2014-0309 and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

    Dated: November 17, 2014.
Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2014-28077 Filed 11-26-14; 8:45 am]
BILLING CODE P


Data Requirement:				PMRA DATA CODE {............}
                        EPA DP Barcode		420823
                        OECD Data Point	{............}
                        EPA MRID 			49307507
                        EPA Guideline		850.4550

Test material:	Dacthal Technical					Purity:	98.3%
Common name:	DCPA
Chemical name:	IUPAC:			Not reported
            CAS name:	Not reported
            CAS No.:		1861-32-1
				Synonyms:		Not reported

Primary Reviewer: Kindra Bozicevich							Signature:
Environmental Scientist, CDM/CSS-Dynamac JV 				Date: 5/16/2016
Secondary Reviewer: Adrian Graff							Signature:
Environmental Scientist, CDM/CSS-Dynamac JV 				Date: 10/21/2020

Primary Reviewer:	Christina M. Wendel						Signature:
EPA/OPP/EFED/ERB2/Biologist 								Date: 10/25/2021

Secondary Reviewer(s): Michael Wagman						Signature:
EPA/OPP/EFED/ERB2/Senior Scientist						Date: 11/18/2021

Reference/Submission No.:  {.....................}

Company Code 		{............}	[For PMRA]
Active Code			{............}	[For PMRA]
Use Site Category:	{............}	[For PMRA]
EPA PC Code 		078701

Date Evaluation Completed: 18-11-2021

CITATION: Arnie, J.R., Martin, K.H., and J.R. Porch. 2013. Dacthal: A 96-Hour Toxicity Test with the Freshwater Alga (Anabaena flos-aquae). Study performed by Wildlife International, Ltd., Easton, Maryland. Project ID 246P-101. Study sponsored by Amvac Chemical Corporation, Los Angeles, CA. Study initiated August 21, 2013 and completed December 5, 2013.

DISCLAIMER: This Data Evaluation Record may have been altered by the Environmental Fate and Effects Division subsequent to signing by CDM/CSS-Dynamac JV personnel. The CDM/CSS-Dynamac Joint Venture role does not include establishing Agency policies.

EXECUTIVE SUMMARY:

In a 96-hour acute toxicity study, cultures of freshwater blue-green alga, Anabaena flos-aquae (strain not reported), were exposed to Dacthal Technical (DCPA) at nominal concentrations of 0 (negative and solvent controls), 31, 63, 125, 250, and 500 ug a.i./L under static conditions. The test substance was unstable under the test conditions with 96-hour measured recoveries ranging from 62 to 68% of the 0-hour concentrations. The reviewer based toxicity values on the initial-measured concentrations, which were <10.0 (<LOQ, controls), 29.9, 63.5, 123, 261, and 535 ug a.i./L.

The % growth inhibition of cell density in the treated algal culture as compared to the control ranged from -79 to 25%. No endpoints were significantly affected and therefore the IC50 and NOEC values for all endpoints (yield, growth rate, and area under the growth curve) were >535 and 535 ug a.i./L, respectively, based on the initial-measured concentrations. Although the results should be approached with some caution as there is high variability in the study endpoints, including control replicates, limiting the ability to discern any potential significant differences. However, there were no effects observed at the solubility limit.

No morphological abnormalities were observed and there were no compound-related phytotoxic effects. The pH on Day 0 was 7.4 and 7.5 in the negative and solvent control groups, respectively, increasing to 8.3 and 8.9, respectively, by Day 4. The pH of the treatment groups on Day 0 ranged from 7.3 to 7.5, increasing to a range of 8.3 to 8.7 on Day 4. The greatest pH increase from Day 0 to 4 was observed in the solvent control (from 7.5 to 8.9).

It should be noted that although the highest nominal concentration is at/above the solubility limit for DCPA (0.5 mg/L), both the stock solutions, and test concentrations were mixed by inversion and sonication and were clear and colorless throughout the test, indicating that the test material was in solution, even though there was low recovery of the test material. Overall this study can still be deemed to be reliable and utilize the initial-measured concentrations for estimating the endpoints.

This study is scientifically sound and is classified as supplemental and the results for the growth endpoint may be used to calculate risk quotients, while the results for the yield and area under the curve endpoints may be used for risk characterization.

Results Synopsis

   Test Organism: Freshwater blue-green alga, Anabaena flos-aquae (strain not reported)
   Test Type (Flow-through, Static, Static Renewal): Static

   Yield, Growth rate, and Area under the curve
   IC05: Not calculable			95% C.I.: N/A
   IC50: >535 ug a.i./L			95% C.I.: N/A
   NOEC: 535 ug a.i./L

   Endpoint(s) Effected: None
   Most Sensitive Endpoint: N/A

I. MATERIALS AND METHODS

   GUIDELINE FOLLOWED:		This study was designed to comply with U.S. EPA OCSPP 850.4550, OECD Guideline 201, and EU Directive 92/69/EEC, Method C.3. The following deficiency and deviations from U.S. EPA OCSPP 850.4550 (2012), OCSPP 850.4000 (2012), OCSPP 850.1000 (2016), and OECD 201 were noted:

 The test substance was unstable under the test conditions, with 96-hour measured concentrations ranging from 62 to 68% of the initial-measured concentrations. According to the current OCSPP/EFED policy with regards to measured concentrations for algae studies, if the chemical is stable throughout the test period, then mean-measured concentrations are used for evaluation of endpoints. If the chemical degrades rapidly then the initial (Day 0) test concentrations are used for evaluation of endpoints. The use of the initial or Day 0 test concentrations are more appropriate for current EFED models. This is the guidance set forth in the EPA Rejection Rate Analysis Ecological Effects handbook (EPA 738-R-94-035, 1994). However, the instability of the test chemical does introduce uncertainty into the degree to which the initial exposures represent the exposure concentrations that elicited the observed effects in the study.
 The strain of the test organism was not reported. This is considered to be a minor deficiency.
 The physicochemical properties of the test item were not reported. This is considered to be a minor deficiency.
 It was noted that the stock cultures were maintained in-house (actively growing) for at least 2 weeks prior to test initiation. According to OCSPP 850.4450 guideline, newly obtained cultures should be maintained in-house for at least 6 weeks prior to use in testing.
 All characteristics of the dilution water (excluding presence of pesticides and metals) were not reported. OCSPP guidance recommend that these parameters are measured and that these water quality characteristics meet EPA specifications. However, the lack of this information is considered to be a minor deficiency as the Kow and solubility of DCPA, (4.3 and 0.5 mg/L, respectively), in water would not result in an underestimation of toxicity.
 The coefficient of variation (CV) based on yield and area under the curve (AUC) for the negative control was 52% and 38%, respectively, which exceeds the OCSPP guideline recommendation of yield CV<15%. The CV based on growth rate for the negative control was 9%, which meets the OCSPP guideline recommendation of growth rate CV<15%. The PMSD for AUC was 56-85% and cell density were 89-179%, indicating there is too much variability in the study compared to its power to discern significant differences. This is considered a major study deficiency.
 The minimum light intensity (1960 lux) was below the OCSPP 850.4550 recommended target of 2150+-10% lux. Only the upper limit of 4440 lux is reported for OECD guidance and the lower limit is not described. OECD guidance does note that Anabaena flos-aquae grow well at lower light intensities and may be damaged at high intensities. The study reported a range of 1960-2230 lux, with a mean of 2133 +- 90.1 (SD); this was within the range of 2150+-10% lux. This is a minor deficiency.

   The deficiency and deviations do affect the validity of the study. Specifically, the high control CVs make interpretation of potential statistical differences difficult for all but the growth rate endpoint. Additionally, the instability of the test compound in the test system introduces uncertainty regarding the actual exposure concentrations that elicited the observed effects. Although the study may be used quantitatively in risk assessment for the growth rate endpoint, it may be used for risk characterization for the yield and area under the curve endpoints.

   COMPLIANCE:			Signed and dated GLP, Quality Assurance, and No Data Confidentiality statements were provided.  The study was conducted in compliance with the GLP standards of the U.S. EPA (40 CFR parts 160 and 792), OECD Principles of GLP ENV/MC/CHEM (98)17, and Japan MAFF 11 NohSan Notification No. 6283 with the following exceptions: periodic analyses of well water for potential contaminants and the characterization of the test substance and the stability of the test substance under the conditions of storage at the test site.

   A. MATERIALS:

   	1. Test material  				Dacthal Technical (DCPA)
      Description: 				Solid
      Lot No./Batch No. : 			090614-2
      Purity: 						98.3%
      Stability of compound
      under test conditions:		Unstable. The 96-hour measured concentrations ranged from 62 to 68% of the initial-measured concentrations.
      Storage conditions of
      test chemicals: 				Stored under ambient and dark conditions.

      Physicochemical properties of Dacthal Technical.
Parameter
Values
Comments
Water solubility at 20°C
Not reported

Vapor pressure
Not reported

UV absorption
Not reported

pKa
Not reported

Kow
Not reported

   2. Test organism:

         Name:					Freshwater blue-green alga (cyanobacteria), Anabaena flos-aquae
         Strain:					Not reported
         Source: 					In-house cultures (maintained at Wildlife International, Easton, MD) originally obtained from the University of Toronto Culture Collection.
         Age of inoculum:		3 days
         Method of cultivation:	Cultured in freshwater AAP algal medium under continuous fluorescent light (2150  10% lux) at 24  2C.

   B.  STUDY DESIGN:

      1. Experimental Conditions

      a. Range-finding study:  A non-GLP, preliminary, range-finding toxicity test was conducted at 5.0, 50, and 500 ug a.i./L and yielded inhibitions of -102, -65, and -86% of mean cell density relative to the negative control, respectively, after 96 hours of exposure. The test solutions were clear and colorless, with no precipitation noted. Test concentrations of the definitive study were selected in consultation with the Sponsor and based on the results of the non-GLP, preliminary, range-finding toxicity test.

         b. Definitive Study

Table 1:  Experimental Parameters
                                   Parameter
                                    Details
                                    Remarks

                                   Criteria
Acclimation period:

Culturing media and conditions:  (same as test or not)

Health:  (any mortality observed)
N/A  -  cultured under test conditions

Same as test; AAP medium (Appendix 3)

Exponential growth phase. No further health observations or mortality were described.
Algal cells used in this test were obtained from cultures actively growing in culture medium for at least two weeks prior to test initiation. Algal cells were transferred to fresh medium three days prior to test initiation.

EPA recommends two week acclimation period.

OECD recommends an amount of algae suitable for the inoculation of test cultures and incubated under the conditions of the test and used when still exponentially growing, normally after an incubation period of about 3 days. When the algal cultures contain deformed or abnormal cells, they must be discarded.
Test system
Static/static renewal

Renewal rate for static renewal

Static

N/A

EPA expects the test concentrations to be renewed every 3 to 4 days (one renewal for the 7 day test, 3-4 renewals for the 14 day test).
Incubation facility
Temperature-controlled environmental chamber at a temperature of 24 +-2°C equipped with a mechanical shaker
Test flasks were manually shaken (swirled) once each day.
Duration of the test
96 hours

EPA requires:  96-120 hours
OECD:  72 hours
Test vessel
Material: (glass/stainless steel)
Size:
Fill volume:

Glass
250 mL
100 mL
Erlenmeyer flasks plugged with sterile foam stoppers

OECD recommends 250 ml conical flasks are suitable when the volume of the test solution is 100 ml or use a culturing apparatus.
Details of growth medium (freshwater AAP medium)
pH at test initiation:
pH at test termination:
Chelator used:
Carbon source:
Salinity (for marine algae):

7.4 (negative control)
8.3 (negative control)
Na2EDTA::2H2O
NaHCO3
N/A

The pH of the medium was adjusted to 7.5+-0.1 using 10% HCl and 0.1N sodium hydroxide.

The medium was sterilized by filtration (0.22 um) prior to use.
Appendix 3 contains the list of AAP algal medium constituents.
Stock nutrient solutions were prepared by adding reagent-grade chemicals to NANOpure(R) water (purified Wildlife International well water).
Appendix 4 contains the results of the most recent analyses (December 26, 2012) performed to measure concentrations of contaminants in well water used to prepare the algal medium.

OECD recommends the medium pH after equilibration with air is ~8 with less than .001 mmol/l of chelator if used.

EPA recommends 20X-AAP and chelating agents (e.g. EDTA) in the nutrient medium for optimum cell growth. Lower concentrations of chelating agents (down to one-third of the normal concentration recommended for AAP medium) may be used in the nutrient medium used for test solution preparation if it is
suspected that the chelator will interact with the test material. ASTM reference, E1415-91and D 3978-80 (reapproved 1987).
If non-standard nutrient medium was used, detailed composition provided (Yes/No)
N/A

Dilution water used to prepare media
Source of dilution water:

Quality of dilution water
Hardness:
Alkalinity:
pH:
Specific conductivity:
Salinity (for marine algae):
Water pretreatment (if any):
TOC:
COD:
Particulate matter:
Metals:
Pesticides/PCBs:
Chlorine:

Wildlife International, Ltd. well water

Not reported
Not reported
Not reported
Not reported
Not reported
None
Not reported
Not reported
Not reported
See remarks
All < Reporting Limit
Not reported
Water analyses were performed on samples collected on December 26, 2012 (Appendix 4).

Metals (mg/L)
Calcium  -  33.5
Chloride  -  4.2
Magnesium  -  12.9
Potassium  -  6.57
Sodium  -  18.2

EPA pH: Skeletonema costatum= ~8.0 Others = ~7.5 from beginning to end of the test. EPA salinity: 30-35 ppt. EPA is against the use of dechlorinated water.

OECD: pH is measured at beginning of the test and at 72 hours, it should not normally deviate by more than one unit during the test.
Indicate how the test material is added to the medium (added directly or used stock solution)
A primary stock solution was prepared by dissolving 0.0509 g of the test substance (dacthal) in 10 mL of N,N-dimethylformamide (DMF) to achieve a nominal concentration of 5.0 mg a.i./mL (based on reported purity of 98.3%). After inversion and sonication, the resulting solution was clear and colorless.  The remaining test concentrations were prepared by serial dilution of the stock solution with DMF and freshwater algal medium. A solvent control solution was also prepared by diluting 50 uL of DMF in 500 mL of freshwater AAP medium. The negative control solution consisted of freshwater AAP medium without test substance or solvent added.
All test solutions were mixed by inversion and were clear and colorless at the time of preparation.
Aeration or agitation
Manually shaken (swirled) once each day

Initial cells density
1.0 x 10[4] cells/mL
Concentration of agal cells in the stock culture was 4.93 x10[5] cells/mL. In order to achieve the desired cell density of approx. 10,000 cells/mL; 2.0 mL of stock culture was added to each replicate test chamber at test initiation.

EPA requires an initial number of 3,000 - 10,000 cells/mL. For Anabaena flos-aquae, cell counts on day 2 are not required.

OECD recommends that the initial cell concentration be approximately 10,000 cells/ml for S. capricornutum and S. subspicatus. When other species are used  the biomass should be comparable.
Number of replicates
Control:
Solvent control:
Treatments:

4
4
4

EPA requires a negative and/or solvent control with 3 or more replicates per doses. Navicula sp.tests should be conducted with four replicate.

OECD preferably three replicates at each test concentration and ideally twice that number of controls. When a vehicle is used to solubilize the test substance, additional controls containing the vehicle at the highest concentration used in the test.
Test concentrations
Nominal:

Mean-Measured

Initial-measured:

0 (negative and solvent controls), 31, 63, 125, 250, and 500 ug a.i./L

<10.0 (<LOQ, controls), 25, 51, 103, 214, and 436 ug a.i./L

<10.0 (<LOQ, controls), 29.9, 63.5, 123, 261, and 535 ug a.i./L

Negative control = freshwater AAP medium

EPA requires at least 5 test concentrations, with each at least 60% of the next higher one.

OECD recommends at least five concentrations arranged in a geometric series, with the lowest concentration tested should have no observed effect on the growth of the algae. The highest concentration tested should inhibit growth by at least 50% relatively to the control and, preferably, stop growth completely.
Solvent (type, percentage, if used)
0.1 mL N,N-Dimethylformamide (DMF)

Method and interval of analytical verification
The test concentrations were measured at 0 and 96 hours using HPLC analysis with UV absorbance at 220 nm.
Samples were collected in duplicate from each experimental group.
Limit of quantitation (LOQ) was 10 ug a.i./L.
Test conditions
Temperature:
Photoperiod:
Light intensity and quality:

24.1 to 25.1ºC
Continuous
1960 to 2230 lux fluorescent light (mean 2133 lux +- 90.1 SD)
23.8 to 24.3 ºC measured continuously

EPA temperature: Skeletonema: 20°C, Others: 24-25°C; EPA photoperiod: S. costatum 14 hr light/ 10 hr dark,  Others: Continuous; EPA light: Anabaena: 2.0 Klux (+-15%), Others: 4 - 5 Klux (+-15%)

OECD recommended the temperature in the range of 21 to25[o]C maintained at +- 2[o]C and continuous uniform illumination provided at approximately 8000 Lux measured with a spherical collector.
Reference chemical (if used)
name:
concentrations:
N/A

Other parameters, if any
N/A

      2. Observations:

Table 2:  Observation parameters
                                  Parameters
                                    Details
                                    Remarks

                                   Criteria
Parameters measured including the growth inhibition/other toxicity symptoms
Cell density
Yield
Growth rate
Area under the growth curve (AUC)

EPA recommends the growth of the algae expressed as the cell count per mL, biomass per volume, or degree of growth as determined by spectrophotometric means.
Measurement technique for cell density and other end points
Cell counts were performed using a hemacytometer and a microscope.

Growth Rate

u = average specific growth rate
No = nominal cell density (cells/mL) at to
Nn = measured cell density at tn
to = time at beginning of test (hours)
tn = time after beginning of test (hours)

Area under the curve
A = ((N1-N0)/2/)(t1)+((N1+N2-2N0)/2/(t2-t1) + ... ((Nn-1+Nn-2N0)/2)(tn-tn-1)
A = area under the growth curve
N0 = Mean nominal number of cells/mL at t0
N1 = Mean measured number of cells/mL at t1
N2 = Mean measured number of cells/mL at t2
Nn = Mean measured number of cells/mL at t0
t0 = test initiation
t1 = time of first measurement (hours)
t2 = time of second measurement (hours)
tn = Time of n[th] measurement (hours)

Yield was calculated as final biomass minus initial biomass.

EPA recommends the measurement technique of cell counts or chlorophyll a

OECD recommends the electronic particle counter, microscope with counting chamber, fluorimeter, spectrophotometer, and colorimeter. (note: in order to provide useful measurements at low cell concentrations when using a spectrophotometer, it may be necessary to use cuvettes with a light path of at least 4 cm).
Observation intervals
Every 24 hours

EPA and OECD: every 24 hours.
Other observations, if any
Cells were observed for morphological effects at test termination.

Indicate whether there was an exponential growth in the control
Yes, after 96 hours, the mean cell densities of the negative and solvent controls were 144 and 101 x 10[4] cells/mL, respectively.

EPA requires control cell count at termination to be >2X initial count or by a factor of at least 16 during the test.

OECD: cell concentration in control cultures should have increased by a factor of at least 16 within three days.
Were raw data included?
Yes.

II. RESULTS and DISCUSSION:

	A. INHIBITORY EFFECTS:

   After 96 hours, mean cell density inhibition in the solvent control was 30% compared to the negative control. In the initial-measured 261 ug a.i./L treatment group, mean cell density inhibition was 25% compared to the negative control. This is the only treatment group where positive inhibitions were observed, as all other treatment groups exhibited a promotion effect in growth (% inhibitions ranging from -79 to -41%). This same trend was observed for cell density yield, growth rate, and area under the curve, although growth rate and area under the curve did not exhibit the same level of growth promotion with % inhibition values ranging from -7 to 12% and -7 to 37% in the treatment groups, respectively. Mean inhibitions were 11 and 36% for growth rate and area under the curve in the solvent control group, respectively. The data were not dose responsive.

   No morphological abnormalities were observed and there were no compound-related phytotoxic effects. The pH on Day 0 was 7.4 and 7.5 in the negative and solvent control groups, respectively, increasing to 8.3 and 8.9, respectively, by Day 4. The pH of the treatment groups on Day 0 ranged from 7.3 to 7.5, increasing to a range of 8.3 to 8.7 on Day 4. The greatest pH increase from Day 0 to 4 was observed in the solvent control, from 7.5 to 8.9.

Table 3: Effect of Dacthal Technical on algal growth (freshwater blue-green alga, Anabaena flos-aquae).
                               Initial-Measured
                          (and Nominal) Concentration
                                  ug a.i./L
                                 Initial cell
                                   density
                               (x10[4] cells/mL)
                        Cell Density (x10[4] cells/mL)

                                   48 hours
                                   72 hours
                                   96 hours

                                 Cell Density
                               % Inhibition [a]
Negative control (<LOQ)
                                     1.00
                                     13.7
                                     62.0
                                      144
                                      N/A
Solvent control (<LOQ)
                                     1.00
                                     11.3
                                     36.8
                                      101
                                      30
29.9 (31)
                                     1.00
                                     15.6
                                     41.0
                                      218
                                      -51
63.5 (63)
                                     1.00
                                     12.0
                                     30.4
                                      206
                                      -42
123 (125)
                                     1.00
                                     12.5
                                     47.0
                                      203
                                      -41
261 (250)
                                     1.00
                                     12.0
                                     30.9
                                      108
                                      25
535 (500)
                                     1.00
                                     13.5
                                     22.6
                                      259
                                      -79
Reference chemical
(if used)
N/A
[a] Calculated by the reviewer relative to the negative control.
Data were obtained from Appendix 6 on pgs. 61-62 of the study report.
LOQ was 10 ug a.i./L
Table 4: Effect of Dacthal Technical on algal growth (freshwater blue-green alga, Anabaena flos-aquae).
                        Initial-Measured (and Nominal)
                                 Concentration
                                  ug a.i./L
                                 Initial cell
                                    density
                               (x10[4] cells/mL)
                               Mean Growth Rate
                                  (hour[-1])
                      Mean Area Under the Curve (AUC)[a]
                                  Mean Yield
                   (based on cell density; x10[4] cells/mL)

                                  0-96 hours
                                % Inhibition[b]
                                  0-96 hours
                                % Inhibition[b]
                                  0-96 hours
                                % Inhibition[b]
Negative control (<LOQ)
                                     1.00
                                    0.0509
                                      N/A
                                  36,975,000
                                      N/A
                                      143
                                      N/A
Solvent control (<LOQ)
                                     1.00
                                    0.0453
                                      11
                                  23,571,000
                                      36
                                     99.9
                                      30
29.9 (31)
                                     1.00
                                    0.0526
                                      -3
                                  39,642,000
                                      -7
                                      217
                                      -52
63.5 (63)
                                     1.00
                                    0.0528
                                      -4
                                  34,368,000
                                       7
                                      205
                                      -43
123 (125)
                                     1.00
                                    0.0512
                                      -1
                                  39,330,000
                                      -6
                                      202
                                      -41
261 (250)
                                     1.00
                                    0.0446
                                      12
                                  23,451,000
                                      37
                                      107
                                      25
535 (500)
                                     1.00
                                    0.0543
                                      -7
                                  39,462,000
                                      -7
                                      258
                                      -80
[a] Calculated by the reviewer as the area under the cell density growth curve.
[b] Calculated by the reviewer relative to the negative control.
Data were obtained from Table 6 on page 25 of the study report.
LOQ was 10 ug a.i./L

Table 5: Statistical endpoint values calculated by the study author in terms of mean-measured (nominal) concentrations.
Statistical endpoint
Cell density
Yield
Growth rate
Area under the curve (AUC)
NOEC (ug a.i./L)
Not calculated
436 (500)
436 (500)
436 (500)
IC50 or EC50 (ug a.i./L)
(95% C.I.)
Not calculated
>436 (500) (N/A)
>436 (500) (N/A)
>436 (500) (N/A)
Reference chemical, if used
NOAEC
IC50/EC50
N/A
N/A = Not applicable.

   B. REPORTED STATISTICS:

   The study author statistically analyzed the yield, growth rate, and area under the curve data using The SAS System for Windows (Version 8.2).  ICx values were calculated using non-linear regression. Negative and solvent control data were compared using a t-test (α = 0.05) and no significant differences were observed. The treatment data were evaluated for normality and homogeneity of variance using Shapiro-Wilk's and Levene's tests, respectively. Because all assumptions were met, the treatment group data were compared to the negative control data using Dunnett's test. Toxicity values were based on mean-measured exposure concentrations.
   C. VERIFICATION OF STATISTICAL RESULTS:

   Statistical Method: The reviewer statistically analyzed 96-hour yield, growth rate, and area under the curve data using CETIS version <IP_ADDRESS> statistical software with database backend settings implemented by EFED on 10/20/15. The initial-measured concentrations were used for analysis and reporting.

   Negative and solvent control data were compared using an Equal Variance t Two-Sample test (α = 0.05) and no significant differences were noted. All further hypothesis testing was conducted comparing treatment data to negative control data only. Based on Bartlett's test (α = 0.01) and Shapiro-Wilk's test (α = 0.01), assumptions of homoscedasticity and normal distribution were met. Because the data were not monotonically decreasing, the reviewer analyzed the endpoint data using Dunnett's Multiple Comparison test (α = 0.05). Due to an absence of statistically significant differences, the reviewer visually determined the IC50 values as greater than the highest initial-measured concentration tested.

   Yield
   IC05: Not calculable			95% C.I.: N/A
   IC50: >535 ug a.i./L			95% C.I.: N/A
   NOEC: 535 ug a.i./L

   Growth rate
   IC05: Not calculable			95% C.I.: N/A
   IC50: >535 ug a.i./L			95% C.I.: N/A
   NOEC: 535 ug a.i./L

   Area under the curve (AUC)
   IC05: Not calculable			95% C.I.: N/A
   IC50: >535 ug a.i./L			95% C.I.: N/A
   NOEC: 535 ug a.i./L

   Endpoint(s) Effected: None
   Most Sensitive Endpoint: N/A

   D.  STUDY DEFICIENCIES:

	The test substance was unstable under the test conditions, with 96-hour measured concentrations ranging from
   62 to 68% of the initial-measured concentrations. According to OCSPP 850.1000, a chemical is unstable if it declines to <80% of the initial-measured test concentrations. According to the current OCSPP/EFED policy with regards to measured concentrations for algae studies, if the chemical is stable throughout the test period, then mean-measured concentrations are used for evaluation of endpoints. If the chemical degrades rapidly then the initial (Day 0) test concentrations are used for evaluation of endpoints. The use of the initial or Day 0 test concentrations are more appropriate for current EFED models. This is the guidance set forth in the EPA Rejection Rate Analysis Ecological Effects handbook (EPA 738-R-94-035, 1994). The coefficient of variation (CV) based on yield and area under the curve (AUC) for the negative control was 52% and 38%, respectively, which exceeds the guideline recommendation of yield CV<15%. The PMSD for AUC was 56-85% and cell density were 89-179%, indicating there is substantial variability in the study and limiting the study's power to discern significant differences. These are considered major study deficiencies that limit the ability to use this study quantitatively in risk assessment for these two endpoints (cell density (yield) and AUC).

   E.  REVIEWER'S COMMENTS:

   The reviewer's results were in general agreement with the study author's results (no biological effects) with differences were attributed to the reviewer's use of initial-measured concentrations for analysis and reporting compared to the study author's use of mean-measured concentrations. The reviewer's results are reported in the Executive Summary and Conclusions sections of this report.

   The in-life phase of the definitive test was conducted from August 26 to 30, 2013, with cell counts completed on September 4, 2013.

   It should be noted that although the highest nominal concentration is at/above the solubility limit for DCPA (0.5 mg/L), both the stock solutions, and test concentrations were mixed by inversion and sonication and were clear and colorless throughout the test, indicating that the test material was in solution, even though there was low recovery of the test material. Overall this study can still be deemed to be reliable and utilize the initial measured concentrations for estimating the endpoints.

   The coefficient of variation (CV) based on yield and area under the curve (AUC) for the negative control was 52% and 38%, respectively, which exceeds the guideline recommendation of yield CV<15%.  The CV based on growth rate for the negative control was 9%, which meets the guideline recommendation of growth rate CV<15%.  The PMSD for AUC was 56-85% and cell density were 89-179%, indicating there is too much variability in the power of the study to discern significant differences. This is considered a major study deficiency.

   F. CONCLUSIONS:

   This study is scientifically sound and is classified as supplemental and the results for the growth endpoint may be used to calculate risk quotients, while the results for the yield and area under the curve endpoints may be used for risk characterization. No morphological abnormalities were observed and there were no compound-related phytotoxic effects. No endpoints were significantly affected and therefore the NOEC and IC50s for all endpoints (yield, growth rate, and area under the growth curve) were 535 and >535 ug a.i./L, respectively, based on the initial-measured concentrations. Although, the results should be considered with caution given the high variability in the test system, including in control replicates, there were no effects observed at the solubility limit of DCPA.

III.  REFERENCES:

American Society for Testing and Materials. 2004. ASTM Standard Guide E1218-04. Standard Guide for Conducting Static Toxicity Tests with Microalgae.

Bruce, Robert D. and Donald J. Versteeg. 1992. A Statistical Procedure for Modeling Continuous Toxicity Data. Environmental Toxicology and Chemistry. 11: 1485-1494.

The SAS System for Windows. 1999-2001. Version 8.2. SAS Institute, Inc. Cary, North Carolina.

Organization for Economic Cooperation and Development. 2006. OECD Guidelines for Testing of Chemicals, Guideline 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test. Adopted 23 March 2006.

U.S. Environmental Protection Agency. 2012. Series 850-Ecological Effects Test Guidelines, OCSPP Number 850.4550: Cyanobacteria (Anabaena flos-aquae) Toxicity.