[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]
[Page 15578-15583]
[DOCID:fr06ap09-150]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket ID FMCSA-2009-0067]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice of applications for exemptions from the diabetes
standard; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 38 individuals
for exemptions 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 commercial motor vehicles in
interstate commerce.

DATES: Comments must be received on or before May 6, 2009.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2009-0067 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.

Each submission must include the Agency name and the docket ID for this
Notice. Note that DOT posts all comments received without change to
http://www.regulations.gov, including any personal information included
in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://Docketinfo.dot.gov.

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

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
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 statutes also allow the
Agency to renew exemptions at the end of the 2-year period. The 38
individuals listed in this notice have recently requested 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 the statutes.

Qualifications of Applicants

Paul Anaya

    Mr. Anaya, age 54, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Anaya meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2009

and certified that he does not have diabetic retinopathy. He holds a
Class A commercial driver's license (CDL) from Colorado.

William C. Arrington

    Mr. Arrington, 51, has had ITDM since 2005. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Arrington meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Maryland.

Gregory W. Arsenault

    Mr. Arsenault, 61, has had ITDM since 2007. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Arsenault meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Connecticut.

Raymond Barajas

    Mr. Barajas, 46, has had ITDM since 2008. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Barajas meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Kansas.

Gary R. Butts

    Mr. Butts, 36, has had ITDM since 2007. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Butts meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New York.

Buck H. Bowers

    Mr. Bowers, 35, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Bowers meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Ohio.

Darin L. Carpenter

    Mr. Carpenter, 42, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Carpenter meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Montana.

William N. Carpenter

    Mr. Carpenter, 30, has had ITDM since 2008. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Carpenter meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Kentucky.

James F. Carroll

    Mr. Carroll, 52, has had ITDM since 2000. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Carroll meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Jeffrey W. Cotner

    Mr. Cotner, 46, has had ITDM since 1996. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cotner meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Oregon.

Randy J. Cool

    Mr. Cool, 52, has had ITDM since 2008. His endocrinologist examined
him in 2008 and certified that he has had no 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 5 years; understands diabetes management
and monitoring; and has stable control of his diabetes using insulin,
and is able to drive a CMV

safely. Mr. Cool meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His optometrist examined him in 2008 and certified
that he does not have diabetic retinopathy. He holds a Class A CDL from
Maryland.

Boyd L. Croshaw

    Mr. Croshaw, 56, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Croshaw meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Utah.

William Frantz

    Mr. Frantz, 47, has had ITDM since 1991. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Frantz meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from
California.

Steven Garcia

    Mr. Garcia, 63, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Garcia meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from New Mexico.

Carl A. George

    Mr. George, 56, has had ITDM since 1999. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. George meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds an operator's license from Virginia.

James E. Gordon, Jr.

    Mr. Gordon, 47, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gordon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2009 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Georgia.

Scott D. Gottheld

    Mr. Gottheld, 38, has had ITDM since 2006. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Gottheld meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class C operator's license from
Pennsylvania.

Juan A. Hartwell

    Mr. Hartwell, 46, has had ITDM since 1997. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hartwell meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Connecticut.

Cole G. Hoff

    Mr. Hoff, 26, has had ITDM since 1992. His endocrinologist examined
him in 2009 and certified that he has had no 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 5 years; understands diabetes management
and monitoring; and has stable control of his diabetes using insulin,
and is able to drive a CMV safely. Mr. Hoff meets the requirements of
the vision standard at 49 CFR 391.41(b)(10). His optometrist examined
him in 2008 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Iowa.

David A. Holzbach

    Mr. Holzbach, 40, has had ITDM since 1975. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Holzbach meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2009 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
South Carolina.

Gary A. Hopkins

    Mr. Hopkins, 62, has had ITDM since 2005. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using

insulin, and is able to drive a CMV safely. Mr. Hopkins meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A3 CDL from South Dakota, which
allows him to operate a combination vehicle greater than 26,000 lbs.
gross vehicle weight rating (GVWR) and with a trailer greater than
10,000 lbs. GVWR.

Joseph T. Jackson

    Mr. Jackson, 44, has had ITDM since 2007. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Jackson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2009 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Connecticut.

Donald A. Lambrecht

    Mr. Lambrecht, 46, has had ITDM since 2007. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lambrecht meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
North Carolina.

William M. Liebert

    Mr. Liebert, 50, has had ITDM since 2005. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Liebert meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nevada.

Howard A. McCowan

    Mr. McCowan, 46, has had ITDM since 2003. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McCowan meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Minnesota.

William J. Mlejnek

    Mr. Mlejnek, 34, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Mlejnek meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

John F. Naughton

    Mr. Naughton, 52, has had ITDM since 2004. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Naughton meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Massachusetts.

Curtis J. Panther

    Mr. Panther, 38, has had ITDM since 2005. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Panther meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Eric S. Ritter

    Mr. Ritter, 30, has had ITDM since 1982. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Ritter meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2009 and certified that he does not
have diabetic retinopathy. He holds a Class C operator's license from
California.

Gary L. Robinson

    Mr. Robinson, 49, has had ITDM since 2000. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Robinson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Tennessee.

Todd J. Schoeller

    Mr. Schoeller, 43, has had ITDM since 1990. His endocrinologist
examined him

in 2008 and certified that he has had no 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 5 years; understands diabetes management
and monitoring; and has stable control of his diabetes using insulin,
and is able to drive a CMV safely. Mr. Schoeller meets the requirements
of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2008 and certified that he has nonproliferative stable
diabetic retinopathy. He holds a Class A CDL from Wisconsin.

Chad W. Schumaker

    Mr. Schumaker, 36, has had ITDM since 1989. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Schumaker meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from
Pennsylvania.

Kevin J. Sears

    Mr. Sears, 48, has had ITDM since 1964. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sears meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class C operator's
license from Illinois.

David W. Slininger

    Mr. Slininger, 35, has had ITDM since 2008. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Slininger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Peter A. Storm

    Mr. Storm, 31, has had ITDM since 2006. His endocrinologist
examined him in 2009 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Storm meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2009 and certified that he does not have
diabetic retinopathy. He holds a Class D chauffeur's license from
Louisiana.

Robert J. Streets

    Mr. Streets, 62, has had ITDM since 2005. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Streets meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Don A. Wisnosky

    Mr. Wisnosky, 52, has had ITDM since 1982. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wisnosky meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
non-proliferative diabetic retinopathy. He holds a Class D operator's
license from Wisconsin.

Patrick D. Yasten

    Mr. Yasten, 39, has had ITDM since 1979. His endocrinologist
examined him in 2008 and certified that he has had no 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 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Yasten meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Nebraska.

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 (SAFETEA-
LU) 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 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) The elimination of the requirement for
three years of experience operating CMVs while being treated with
insulin; and (2) the 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. 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.

    Issued on: March 31, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-7636 Filed 4-3-09; 8:45 am]


[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Proposed Rules]
[Page 27783-27786]
[DOCID:fr14my08-25]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2008-0178; FRL-8565-5]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Section 110(a)(1) 8-Hour Ozone Maintenance Plan and 2002
Base-Year Inventory for the Columbia County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Pennsylvania. The
Pennsylvania Department of Environmental Protection (PADEP) submitted a
SIP revision consisting of a maintenance plan that provides for
continued attainment of the 8-hour ozone national ambient air quality
standard (NAAQS) for at least 10 years after the April 30, 2004
designations, as well as a 2002 base-year inventory for the Columbia
County Area. EPA is proposing approval of the maintenance plan and the
2002 base-year inventory in accordance with the requirements of the
Clean Air Act (CAA).

DATES: Written comments must be received on or before June 13, 2008.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2008-0178 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>

    C. Mail: EPA-R03-OAR-2008-0178, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2008-0178. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://
www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at Pennsylvania Department of
Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468,
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 17, 2007, PADEP formally
submitted for approval, under section 110(a)(1) of the CAA, a SIP
revision for the 8-hour ozone maintenance plan and the 2002 base-year
inventory for the Columbia County Area.

I. Background

    Section 110(a)(1) of the CAA requires that states submit to EPA
plans to maintain the NAAQS promulgated by EPA. EPA interprets this
provision to require that areas that were maintenance areas for the 1-
hour ozone NAAQS, but attainment for the 8-hour ozone NAAQS, submit a
plan to demonstrate the continued maintenance of the 8-hour ozone
NAAQS.
    On May 20, 2005, EPA issued guidance that applies to areas that are
designated unclassifiable/attainment for the 8-hour ozone standard. The
purpose of this guidance is to address the maintenance requirements in
section 110(a)(1) of the CAA, and to assist the states in the
development of a SIP. The components from EPA's guidance include: (1)
An attainment emissions inventory, which is based on actual ``typical
summer day'' emissions of volatile organic compounds (VOCs) and
nitrogen oxides (NOX) for a 10-year maintenance period, from
a base-year chosen by the state; (2) a maintenance demonstration, which
demonstrates how the area will remain in compliance with the 8-hour
ozone standard for a period of 10 years following the effective date of
designation unclassifiable/attainment (June 15, 2004); (3) an ambient
air monitoring network, which will be in continuous operation in
accordance with 40 CFR Part 58 to verify maintenance of the 8-hour
ozone standard; (4) a contingency plan, that will ensure that in the
event of a violation of the 8-hour ozone NAAQS, measures will be
implemented as promptly as possible; (5) a verification of continued
attainment, indicating how the state intends on tracking the progress
of the maintenance plan.

II. Summary of SIP Revision

    The Commonwealth of Pennsylvania has requested approval of its 8-
hour ozone maintenance plan and 2002 base-year inventory for the
Columbia County Area. The PADEP 8-hour ozone maintenance plan addresses
the five components of EPA's May 20, 2005 guidance, which pertains to
the maintenance requirements in section 110(a)(1) of the CAA.
    Attainment Emission Inventory: An attainment emissions inventory
includes emissions during the time period associated with the
monitoring data showing attainment. PADEP has provided an emissions
inventory for VOCs and NOX, using 2002 as the base-year from
which to project emissions. The 2002 inventory is consistent with EPA
guidance, is based on actual ``typical summer day'' emissions of VOCs
and NOX, and consists of a list of sources and their
associated emissions. PADEP prepared comprehensive VOCs and
NOX emissions inventories for the Columbia County Area. In
the maintenance plan, PADEP included information on the man-made
sources of ozone precursors, VOCs and NOX (e.g.,
``stationary sources,'' ``stationary area sources,'' ``highway
vehicles,'' and ``nonroad sources'').
    Pennsylvania projected emissions for beyond 10 years from the
effective date of the April 30, 2004 designations for the 8-hour ozone
standard. PADEP has developed an emissions inventory for ozone
precursors for the year 2002, 2009, and 2018. Tables 1 and 2 show the
VOCs and NOX emissions reduction summary for 2002, 2009, and
2018.

          Table 1.--VOC Emissions Summary: 2002, 2009 and 2018
                          [Tons per summer day]
------------------------------------------------------------------------
      Major source category            2002         2009         2018
------------------------------------------------------------------------
Stationary Point Sources.........         0.32         0.35         0.45
Stationary Area Sources..........         4.72         4.50         4.67
Highway Vehicles.................         4.47         2.52         1.47
Nonroad Sources..................         1.83         1.83         1.72
                                  --------------------------------------
    Total........................        11.34         9.20         8.31
------------------------------------------------------------------------

          Table 2.--NOX Emissions Summary: 2002, 2009 and 2018
                          [Tons per summer day]
------------------------------------------------------------------------
      Major source category            2002         2009         2018
------------------------------------------------------------------------
Stationary Point Sources.........         0.42         0.44         0.46
Stationary Area Sources..........         0.38         0.40         0.41
Highway Vehicles.................         8.89         4.84         2.13
Nonroad Sources..................         1.72         1.37         0.83
                                  --------------------------------------
    Total........................        11.41         7.05         3.83
------------------------------------------------------------------------

    EPA believes Pennsylvania has demonstrated that the VOCs and
NOX emissions in the Columbia County Area will improve due
to permanent and enforceable reductions in emissions resulting from
implementation of the SIP, federal measures, and other state-adopted
measures.
    Maintenance demonstration: As Table 1 and 2 indicate, the Columbia
County Attainment Area plan shows maintenance of the 8-hour ozone NAAQS
by demonstrating that future emissions of VOCs and NOX
remain at or below the 2002 base-year emissions levels through the year
2018.
    Based upon the comparison of the projected emissions and the 2002
base-year inventory emissions, along federal and state measures, EPA
concludes that PADEP successfully demonstrates that the 8-hour ozone
standard will be maintained in the Columbia County Area. Further
details of Columbia County Attainment Area's 8-hour ozone maintenance
demonstration can be found in a Technical Support Document (TSD)
prepared for this rulemaking.
    Ambient Air Quality Monitoring: With regard to the ambient air
monitoring component of the maintenance plan, Pennsylvania commits to
continue operating its current air quality monitoring stations in
accordance with 40 CFR Part 58, to verify the attainment status of the
area, with no reductions in the number of sites from those in the
existing network unless pre-approved by EPA.
    Contingency Plan: Section 110(a)(1) of the CAA requires that the
state develop a contingency plan which will ensure that any violation
of a NAAQS is promptly corrected. The purpose of the contingency plan
is to adopt measures, outlined in the maintenance plan, in order to
assure continued attainment in the event of a violation of the 8-hour
ozone NAAQS. The maintenance plan should identify the events that would
``trigger'' the adoption and implementation of a contingency
measure(s), the contingency measure(s) that would be adopted and
implemented, and the schedule indicating the time frame by which the
state would adopt and implement the measure(s).
    Since the Columbia County Area does not have a monitor, contingency
measures will be considered if for two consecutive years the fourth
highest 8-hour ozone concentrations at the design monitor for the
Scranton-Wilkes-Barre Area are above 84 parts per billion (ppb). If
this trigger point occurs, PADEP will evaluate whether additional local
emission control measures should be implemented in Columbia County in
order to prevent a violation of the air quality standard. PADEP will
analyze the conditions leading to the excessive ozone levels and
evaluate what measures might be most effective in correcting the
excessive ozone levels. PADEP will also analyze the potential emissions
effect of federal, state, and local measures that have been adopted but
not yet implemented at the time the excessive ozone levels occurred.
PADEP will then begin the process of implementing the contingency
measures outlined in their maintenance plan.
    Verification of continued attainment: PADEP will track the
attainment status of the 8-hour ozone NAAQS for Columbia County by
reviewing air quality at the design monitor for the Scranton-Wilkes-
Barre Area and emissions data during the maintenance period. An annual
evaluation of vehicle miles traveled and emissions reported from
stationary sources will be performed and compared to the assumptions
about the factors used in the maintenance plan. PADEP will also
evaluate the periodic (every three years) emission inventories prepared
under EPA's Consolidated Emission Reporting Regulation (40 CFR part 51,
Subpart A) for any unanticipated increases. Based on these evaluations,
PADEP will consider whether any further emission control measures
should be implemented.

III. Proposed Action

    EPA is proposing to approve the maintenance plan and the 2002 base-
year inventory for the Columbia County Area, submitted on December 17,
2007, as revisions to the Pennsylvania SIP. EPA is proposing to approve
the maintenance plan and 2002 base-year inventory for the Columbia
County Area because it meets the requirements of section 110(a)(1) of
the CAA. EPA is soliciting public comments on the issues discussed in
this document. These comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of

the CAA. Accordingly, this action merely proposes to approve state law
as meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule to approve the maintenance plan and
the 2002 base-year inventory for the Columbia County Area in the
Commonwealth of Pennsylvania does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 5, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.
[FR Doc. E8-10811 Filed 5-13-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62489-62494]
[FR Doc No: 2018-26343]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0820; FRL-9986-87]

Oxytetracycline; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
oxytetracycline in or on fruit, citrus, crop group 10-10. Geo Logic
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 4, 2018. Objections and
requests for hearings must be received on or before February 4, 2019
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0820, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0820 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 4, 2019. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0820, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), EPA issued a document pursuant to

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of
a pesticide petition (PP 5F8415) by Geo Logic Corporation, P.O. Box
3091, Tequesta, FL 33469. The petition requested that 40 CFR 180.337 be
amended by establishing tolerances for residues of the bactericide
oxytetracycline, (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-
1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-
1,11-dioxo-2-naphthacenecarboxamide, in or on fruit, citrus, crop group
10-10 at 0.01 parts per million (ppm).
    That document referenced a summary of the petition prepared by Geo
Logic Corporation, the registrant, which is available in the docket,
http://www.regulations.gov. One comment was received on the notice of
filing. EPA's response to this comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for oxytetracycline including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with oxytetracycline
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    At high doses, the target organ of tetracycline toxicity is the
liver. The most common effect in intermediate- or long-term oral
exposures in rats and mice was a decrease in body weight. In the
prenatal developmental study in rats, clinical signs included increased
incidences of respiratory signs and rough hair coat in the dams, in
addition to increased mortality and a decreased percentage of dams
found pregnant. Also identified was a decrease in fetal body weight. In
the mouse prenatal developmental study, there was no toxicity
identified in the dams or fetuses. In all of the above animal studies,
adverse effects were seen at doses that exceed the limit dose. There is
no adequate reproductive toxicity study available in the database,
however, the data requirement was waived based on the lack of
reproductive effects reported during the history of use as a drug. No
evidence of neurotoxicity was observed in any guideline study. A rat
immunotoxicity study demonstrated immunosuppression at doses lower than
those for systemic toxicity. Tetracyclines are known to inhibit bone
growth in developing tissue. When oxytetracycline was administered
orally as a single dose to two female infant rhesus monkeys, zygomatic
arch bone (lateral surface of temporal bone) growth was inhibited for
~12.5 days with no recovery observed by 21 days. Effects on bone growth
are consistent with oxytetracycline's ability to chelate calcium, and
so are not unexpected. Bone developmental effects were also observed
after administration of chlortetracycline and demethylchlortetracycline
in adult rhesus monkeys highlighting the consistency of tetracycline
treatment across this class of chemicals.
    The Agency has classified oxytetracycline as ``Group D: Not
Classifiable as to Human Carcinogenicity''. Oxytetracycline has low
acute toxicity, being Toxicity Category IV for oral toxicity, the only
acute lethality study available in the database.
    Specific information on the studies received and the nature of the
adverse effects caused by oxytetracycline as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Oxytetracycline/Oxytetracycline
Hydrochloride/Oxytetracycline Calcium: Draft Human Health Risk
Assessment in Support of Registration Review and Tolerance
Establishment in/on Citrus Fruit Crop Group 10-10'' in docket ID number
EPA-HQ-OPP-2015-0820.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

     Table 1--Summary of Toxicological Doses and Endpoints for Oxytetracycline for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..  None selected.......  N/A................  No appropriate endpoint for
                                                                               females age 13-49 or for the
                                                                               general population attributable
                                                                               to a single exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 100 mg/kg/day  Chronic RfD = 1 mg/  WOE from 3 rats and 2 dogs chronic
                                   UFA = 10x...........   kg/day.              studies.
                                   UFH = 10x...........  cPAD = 0.10 mg/kg/   The NOAEL of 100 mg/kg/day was
                                   FQPA SF = 10x.......   day.                 derived from these studies and no
                                                                               specific LOAEL was established.
                                  ------------------------------------------------------------------------------
Cancer...........................         Classified as a Group D carcinogen--not classifiable as to human
                                                                  carcinogenicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to oxytetracycline, EPA considered exposure under the
petitioned-for tolerances as well as all existing oxytetracycline
tolerances in 40 CFR 180.337. EPA assessed dietary exposures from
oxytetracycline in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for oxytetracycline; therefore,
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA 2003-2008 food consumption data from the USDA's National
Health and Nutrition Examination Survey/What We Eat in America. As to
residue levels in food, EPA used tolerance-level residues, default
processing factors (PFs), and assumed 100 percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that oxytetracycline does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for oxytetracycline. Tolerance-level residues and/or 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for oxytetracycline in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of oxytetracycline. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model version 5.02/Variable Volume
Water Body Model (VVWM V1.02) and Pesticide Root Zone Model Ground
Water (PRZM GW), EDWCs of oxytetracycline for chronic exposures for
non-cancer assessments are estimated to be 2.85 ppb for surface water
and 0.323 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 2.85 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Oxytetracycline is
not registered for any specific use patterns that would result in
residential exposure.
    Tetracycline hydrochloride (97% chemical similarity to
oxytetracycline) is approved by FDA for use as an oral antibiotic to
treat certain bacterial and parasitic infections. EPA examined the
impact that additional pesticide exposures to oxytetracycline would
have on a person who has been prescribed the antibiotic. EPA determined
that the additional pesticide exposure would not have more than a
minimal impact on the total dose to the pharmaceutical patient, and
thus concludes that there is a reasonable certainty that the additional
exposure from pesticide uses of oxytetracycline would result in no harm
finding to a user being treated therapeutically.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has assessed the potential for oxytetracycline to share a
common mechanism of toxicity with any other substances. Based on its
assessment of the available toxicological data, EPA has determined that
oxytetracycline does not share a similar toxicological profile with
other pesticides, and no further cumulative evaluation is necessary for
oxytetracycline.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Considering the toxicity
database for oxytetracycline, the mouse prenatal development study did
not identify adverse effects up to the highest dose tested (HDT), 2,100
mg/kg/day. In addition, the effects seen in the rat prenatal
development study occurred only at levels above the limit dose.
Although guideline toxicity studies do not suggest an increased
lifestage sensitivity/susceptibility (effects above the limit dose or
no effects at the highest doses tested), data from the literature
suggests that developing infants and children may be more susceptible
to oxytetracycline side-effects than adults. When oxytetracycline was
administered orally, as a single dose, to two female infant rhesus
monkeys, zygomatic arch bone (lateral surface of temporal bone) growth
was inhibited for ~12.5 days with no recovery observed by 21 days. The
delayed bone growth occurs as a result of chelation of calcium, the
mineral needed for bone growth. When the monkeys are treated with a
very high dose of oxytetracycline (80 mg/kg), the calcium can be bound
up for several days, leading to a delay in bone growth during that
short time frame. However, once the oxytetracycline levels diminish,
bone growth continues resulting in normal bones at maturity.
    3. Conclusion. The existing database, together with the extensive
literature and study reports available on oxytetracycline, including
studies submitted to and reviewed by the EPA, the National Toxicology
Program, and World Health Organization, the FDA and open literature
studies, is adequate for characterizing toxicity and quantification of
risk from the proposed and existing uses of oxytetracycline. EPA is
retaining the 10X FQPA SF because of the potential for pre-natal
toxicity. The Agency concludes that this safety factor will be
protective of potential toxicity to infants and children based on the
following findings:
    i. The toxicity database for oxytetracycline is complete.
    ii. There is no indication that oxytetracycline is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that oxytetracycline results in increased
susceptibility in in utero rats in the prenatal developmental studies.
Within the toxicity database, the mouse prenatal developmental study
did not identify adverse effects up to the highest does tested (HDT),
2,100 mg/kg/day. Based on the adverse effects seen in infant rhesus
monkeys after oral administration of oxytetracycline, the Food Quality
Protection Act (FQPA) Safety Factor (SF) is being retained at 10X.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary assessment overestimates actual exposures to
oxytetracycline as it incorporated tolerance-level residues, default
PFs, assumed that 100% of the proposed and existing crops are treated
with oxytetracycline, and included high-end ground and surface drinking
water modeling estimates. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to oxytetracycline in drinking water. These assessments will
not underestimate the exposure and risks posed by oxytetracycline.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
oxytetracycline is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
oxytetracycline from food and water will utilize 33% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential pesticide uses for oxytetracycline.
    3. Short-term risk and Intermediate-term risk. Short-term and
intermediate-term aggregate exposures take into account short-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level) and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level), respectively. Short and
intermediate-term adverse effects were identified; however,
oxytetracycline is not registered for any residential pesticide uses
that would result in short or intermediate-term residential exposures.
Short-term risk is assessed based on short-term residential exposure
plus chronic dietary exposure and intermediate-term risk is assessed
based on intermediate-term residential exposure plus chronic dietary
exposure. Because there are no short-term or intermediate-term
residential exposures and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
oxytetracycline.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in adequate carcinogenicity studies in two
animals, oxytetracycline is not expected to pose a cancer risk to
humans and no cancer risk assessment was necessary.
    5. Pharmaceutical aggregate risk for U.S. population. Section 408
of the FFDCA requires EPA to consider potential sources of exposure to
a pesticide and related substances in addition to the dietary sources
expected to result from a pesticide use subject to the tolerance and
determine that ``there is a reasonable certainty of no harm'' from
those exposures. Because the Food and Drug Administration (FDA) may
approve pharmaceutical drugs under FFDCA section 505, notwithstanding
the possibility that some users may experience adverse side effects.
EPA examines the impact that the additional pesticide exposures would
have to a pharmaceutical user exposed to a related (or, in some cases,
the same) compound in assessing the potential of harm to the
pharmaceutical user. Where the additional pesticide exposure has no
more than a minimal impact on the pharmaceutical user, EPA has
concluded that it can make a reasonable certainty of no harm finding
for the pesticide tolerances of that compound under section 408 of the
FFDCA.
    For oxytetracycline, EPA's pesticide exposure assessment has taken
into consideration the appropriate population, exposure route, and
exposure duration for comparison with pharmaceutical exposure to
oxytetracycline. EPA estimates that the pharmaceutical exposure a
person is expected to receive from a typical therapeutic dose (25 mg/
kg/day for children) is 750 to 2,800 times greater

than the estimated dietary exposure from the pesticidal sources of
oxytetracycline (0.0089334 mg/kg/day). Therefore, because the pesticide
exposure has no more than a minimal impact on the total dose to a
pharmaceutical user, EPA concludes that there is a reasonable certainty
that the potential pesticide exposure will result in no harm to a
person being treated therapeutically with oxytetracycline.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to oxytetracycline residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determining
oxytetracycline residues in/on plant commodities. A high-performance
liquid chromatography method with tandem mass spectrometry detection
(LC/MS/MS) has been proposed for tolerance enforcement.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for oxytetracycline.

C. Response to Comments

    One comment was received generally opposing the use of any
pesticides in or on food. The Agency recognizes that some individuals
oppose the use of pesticides in or on food, but the FFDCA authorizes
the Agency to establish tolerances for residues of pesticides in or on
food if the Agency determines that the tolerance is safe. EPA has
examined all the available data and determined that there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue. The commenter has provided no
information to support a finding that the tolerances would not be safe.

V. Conclusion

    Therefore, tolerances are established for residues of
oxytetracycline, in or on fruit, citrus, group 10-10 at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 23, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Program.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.337, add alphabetically the entry for ``Fruit, citrus,
group 10-10'' to the table in paragraph (a) to read as follows:

Sec.  180.337   Oxytetracycline; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, citrus, group 10-10..............................            0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-26343 Filed 12-3-18; 8:45 am]
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[Federal Register: December 8, 2009 (Volume 74, Number 234)]
[Notices]
[Page 64687-64689]
[DOCID:fr08de09-31]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9086-5; Docket ID No. EPA-HQ-ORD-2009-0857]

ICLUS SERGoM v3 User's Manual: ArcGIS Tools and Datasets for
Modeling U.S. Housing Density Growth

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: EPA is announcing a 30-day public comment period for the draft
tool and its documentation titled, ``ICLUS

SERGoM v3 User's Manual: ArcGIS Tools and Datasets for Modeling US
Housing Density Growth'' (EPA/600/R-09/143). The tool and its
documentation were prepared by the National Center for Environmental
Assessment within EPA's Office of Research and Development. This draft
tool and its documentation can be used to vary housing density and
other allocation assumptions used to run land use scenarios for the
conterminous US. ICLUS stands for Integrated Climate and Land Use
Scenarios, a project which is described in the 2009 EPA Report, ``Land-
Use Scenarios: Nation-Scale Housing-Density Scenarios Consistent with
Climate Change Storylines.'' These scenarios are broadly consistent
with global-scale, peer-reviewed storylines of population growth and
economic development, which are used by climate change modelers to
develop projections of future climate. SERGoM is the Spatially Explicit
Growth Model used to allocate housing on the landscape in the GIS
environment. This tool and User's Guide enable users to run SERGoM with
the population projections developed for the ICLUS project and allow
users to modify the spatial allocation of housing density across the
landscape.
    The public comment period and the external peer usability review,
which will occur after the public comment period, are separate
processes that provide opportunities for all interested parties to
comment on the document. EPA intends to forward the public comments
that are submitted in accordance with this notice to the external peer
reviewers prior to their review for their consideration. When
finalizing the draft document, EPA intends to consider any public
comments that EPA receives in accordance with this notice.
    EPA is releasing this draft tool and its documentation solely for
the purpose of pre-dissemination peer review under applicable
information quality guidelines. This tool and its documentation have
not been formally disseminated by EPA. It does not represent and should
not be construed to represent any Agency policy or determination.

DATES: The 30-day public comment period begins December 8, 2009, and
ends January 7, 2010. Technical comments should be in writing and must
be received by EPA by January 7, 2010.

ADDRESSES: The draft Geographic Information System (GIS) tool and its
documentation, ``ICLUS SERGoM v3 User's Manual: ArcGIS Tools and
Datasets for Modeling US Housing Density Growth'' are available
primarily via the Internet on the National Center for Environmental
Assessment's home page under the Recent Additions menu at http://
www.epa.gov/ncea. A limited number of paper copies of the User's Guide
are available from the Information Management Team, NCEA; telephone:
703-347-8561; facsimile:<PHONE_NUMBER>. If you are requesting a paper
copy, please provide your name, your mailing address, and the document
title, ``ICLUS SERGoM v3 User's Manual: ArcGIS Tools and Datasets for
Modeling US Housing Density Growth.''
    Comments may be submitted electronically via http://
www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>    For technical information, contact Britta Bierwagen, NCEA;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About the Project/Document

    The GIS tool and its documentation, ``ICLUS SERGoM v3 User's
Manual: ArcGIS Tools and Datasets for Modeling US Housing Density
Growth,'' enable users to run SERGoM with the population projections
developed for the ICLUS project and allow users to modify the spatial
allocation of housing density across the landscape. The data provided
from the ICLUS project consist of five population scenarios by county
for the conterminous US and are available in 5-year increments from
2000 to 2100. The population projections for each US county drive the
production of new housing units, which are allocated in response to the
spatial pattern of previous growth (e.g., 1990 to 2000), transportation
infrastructure, and other basic assumptions. The housing allocation
model recomputes housing density in 10-year time steps.
    The GIS tool allows users to:
     Replace the ICLUS projected population values to reflect
different growth rate assumptions;
     customize housing density patterns by altering household
size and travel time assumptions;
     summarize patterns by region, watershed, county, or NLCD
2001 land cover classes;
     reclassify housing density into classes different than
those already provided; and
     generate a map of estimated impervious surface based on a
housing density map.

II. How To Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD 2009-
0857, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, Room 3334, EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center's Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information.
    If you provide comments by mail or hand delivery, please submit
three copies of the comments. For attachments, provide an index, number
pages consecutively with the comments, and submit an unbound original
and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0857. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://

www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, such as CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: November 19, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-29218 Filed 12-7-09; 8:45 am]

BILLING CODE 6560-50-P