Potential Effects of Atrazine on Amphibian Gonadal Development, 16357-16359 [E7-6253]
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Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
www.regulations.gov or e-mail. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
jlentini on PROD1PC65 with NOTICES
II. Background
What Action is the Agency Taking?
Under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136p), at the
discretion of the Administrator, a
Federal or State agency may be
exempted from any provision of FIFRA
if the Administrator determines that
emergency conditions exist which
require the exemption. USDA has
requested the Administrator to issue a
quarantine exemption for the use of EtO
on the interior surfaces of enclosed
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animal isolator units to inactivate forms
of microbial life in an inanimate
environment, including all forms of
vegetative bacteria, bacterial spores,
fungi, fungal spores, and viruses to
create a germ free environment for
animal research. Information in
accordance with 40 CFR part 166 was
submitted as part of this request.
As part of this request, the Applicant
asserts that there are no control
products labeled for this use on animal
isolator units which could provide the
degree of sterilization required for the
conduct of this research. Without the
ability to sterilize the animal isolator
units, NVSL and NADC would not be
able to conduct studies of national
importance.
The Applicant proposes to make no
more than 20 applications of the
chemical per year, using the EPA
registered product Oxyfume 2002
ethylene oxide sterilant (a blend of 10%
ethylene oxide; 90% refrigerant gas), to
sterilize a maximum of nine tub
isolators for pigs, nine auxiliary
isolators that attach to the tub isolators
for pigs, two tub isolators for calves and
two auxiliary isolators that attach to the
tub isolators for calves. A total of five
pounds of the chemical mixture will be
used to sterilize each animal isolator
unit for a maximum of 1,000 lbs of
Oxyfume 2002 per year. A maximum
of 100 lbs a.i. will be applied per year.
The chemical will be used to sterilize
the animal isolator units on an as
needed basis to conduct research at
NVSL and NADC over the period for
which the quarantine exemption will be
granted (3 years).
The regulations governing section 18
of FIFRA require publication of a Notice
of Receipt of an application for a
quarantine exemption under certain
circumstances. The applicant proposes
the use of a pesticide containing an
active ingredient which is the subject of
a Special Review and that is one of the
criteria for preparing a Notice of Receipt
for certain emergency exemption
requests (40 CFR 166.24). As noted
above, the Agency has eliminated the
comment period due to the urgent
nature of the emergency situation and
the very narrow and extremely limited
use being requested. Nonetheless,
interested parties may still contact the
Agency with comments about this
notice and treatment program.
List of Subjects
Environmental protection, Pesticides
and pests.
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16357
Dated: March 27, 2007.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
[FR Doc. E7–6249 Filed 4–3–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2007–0204; FRL–8120–9]
Potential Effects of Atrazine on
Amphibian Gonadal Development
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: In October 2007, EPA will
make a presentation to the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) Scientific Advisory Panel
(SAP) concerning EPA’s evaluation of
the scientific research investigating
whether exposure to the herbicide
atrazine potentially affects amphibian
gonadal development. The scientific
research will include studies that were
conducted by Syngenta Crop Protection,
Inc. in 2005 and 2006 as well as
published open literature studies. The
notice identifies the open literature
studies that EPA has reviewed and
requests public comment to ensure that
the list of publications is complete. The
studies that have been reviewed focus
on testing atrazine alone and only on
atrazine’s potential effects on amphibian
gonadal development.
DATES: Comments must be received on
or before May 4, 2007.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2007–0204, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2007–
E:\FR\FM\04APN1.SGM
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jlentini on PROD1PC65 with NOTICES
16358
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices
0204. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
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 regulations.gov or email. The Federal regulations.gov
website 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 regulations.gov, your email address will be automatically
captured and included as part of the
comment that is placed in the 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 docket
are listed in the docket index available
in regulations.gov. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
web site to view the docket index or
access available documents. Although
listed in the index, some information is
not publicly available, e.g., 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 in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
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17:57 Apr 03, 2007
Jkt 211001
holidays. The Docket telephone number
is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Thomas Steeger, Environmental Fate
and Effects Division, Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: 703–305–5444; fax number:
703–305–7695; e-mail address:
steeger.thomas@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of particular
interest to those persons who hold or
seek registrations of pesticide products
containing atrazine under FIFRA. This
action may also be of particular interest
to those who have published research
regarding the potential effects of
atrazine on amphibian gonadal
development. Since other entities may
also be interested, EPA has not
attempted to describe all the specific
entities that may be affected by this
action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
When submitting comments
identifying additional open literature
studies that should be reviewed by EPA,
commentors should provide a complete
citation following the format of the
studies listed in this notice. If possible,
a copy of the open literature study
should be submitted as well.
II. Background
A. What Action is the Agency Taking?
In April 2002, EPA completed a
revised science chapter that
characterized the ecological effects of
atrazine in support of an Interim
Reregistration Eligibility Decision
(IRED). At about the same time,
scientific articles were published
regarding the potential effects of
atrazine on amphibian gonadal
development, and concerns were raised
that EPA had not sufficiently accounted
for these data in its risk assessment. In
response to an amended consent decree
between EPA and the Natural Resources
Defense Council (NRDC), EPA issued an
atrazine IRED in January 31, 2003 which
stipulated that EPA would issue a
revised IRED by October 31, 2003. The
revised IRED would incorporate
recommendations and comments from a
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Sfmt 4703
FIFRA Scientific Advisory Panel (SAP)
regarding studies, submitted by
February 28, 2003, on the potential
effects of atrazine on amphibians. EPA
also agreed to develop a paper, at least
three months prior to signing this
revised IRED, and submit it to the SAP
for review and comment.
In accordance with the consent
decree, EPA conducted an extensive
review of open literature and registrantsubmitted studies concerning the
potential effects of atrazine on
amphibian gonadal development. After
a thorough assessment of all of these
studies, EPA concluded there was
sufficient information to hypothesize
that atrazine exposure can result in
effects on amphibian gonadal
development, but there was insufficient
evidence to refute or confirm that
hypothesis because the collective
studies failed to show that atrazine
produced consistent, reproducible
effects across the range of exposure
concentrations and amphibian species
tested in the studies. EPA summarized
the studies and its evaluation of the
studies in a White Paper and presented
its analysis, conclusions, and
recommendations to the SAP during a
meeting held on June 17 – 20, 2003.
The SAP concurred with EPA’s
interpretation of the available data and
with EPA’s recommendations to seek
additional data. Additionally, the SAP
concurred with the study approach
described in the White Paper for
addressing uncertainties identified in
the available studies. (For further
information regarding this SAP meeting
and to obtain a copy of the White Paper
and the SAP’s report, refer to https://
www.epa.gov/scipoly/sap/meetings/
2003/index.htm#061703.)
In response to the uncertainties
identified in the White Paper and based
on the recommendations made by the
SAP, EPA issued a Data Call-in Notice
(DCI) on November 12, 2004, to
Syngenta Crop Protection, Inc.
(Syngenta) and other atrazine
registrants. The DCI required amphibian
studies be conducted to determine if
exposure to atrazine can affect
amphibian gonadal development.
Secondary objectives of these studies
were to provide information on the
repeatability of previous observations,
to develop a sound dose-response
relationship, and to determine the
developmental sensitivity of the
amphibian species that are being tested.
Syngenta has initiated the studies
according to EPA-approved protocols
and expects to submit the final study
results to EPA in 2007.
On October 9 -12, 2007, EPA will
return to the SAP with a second White
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jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 64 / Wednesday, April 4, 2007 / Notices
Paper discussing the results of
Syngenta’s amphibian studies
conducted in 2005 - 2006. In addition,
EPA has continued to review the open
literature studies investigating whether
atrazine exposure affects amphibian
gonadal development. For this second
SAP meeting, EPA plans to include only
those studies that tested atrazine alone
and examined atrazine’s potential
effects on amphibian gonadal
development. Studies on mixtures of
pesticides that include atrazine as well
as studies of the potential for atrazine to
cause adverse effects other than or in
addition to amphibian gonadal
development are not being considered
for the SAP meeting.
In this Federal Register Notice, EPA is
soliciting public comment on the
completeness of its list of open
literature studies on the potential effects
of atrazine on amphibian gonadal
development. If other publications
relevant to these potential effects are
available and have not been included in
this list, EPA requests that citations be
submitted during the comment period.
If possible, a copy of the publication
should be submitted as well.
EPA has reviewed the following list of
relevant open literature studies in
preparation for the October SAP
meeting:
1. Coady K.K., Murphy M.B.,
Villeneuve D.L., Hecker M., Jones P.D.,
Carr J.A., Solomon K.R., Smith E.E., Van
der Kraak G., Kendall R.J., and J.P.
Giesy. 2004. Effects of Atrazine on
Metamorphosis, Growth, Laryngeal and
Gonadal Development, Aromatase
Activity, and Plasma Sex Steroid
Concentrations in Xenopus laevis.
Ecotoxicology and Environmental Safety
62:160–173. MRID 458677–04.
2. Coady K.K., Murphy M.B.,
Villeneuve D.L., Hecker M., Jones P.D.,
Carr J.A., Solomon K.R., Smith E.E., Van
der Kraak G., Kendall R.J., and J.P.
Giesy. 2004. Effects of Atrazine on
Metamorphosis, Growth, and Gonadal
Development in the Green Frog (Rana
clamitans). Journal of Toxicology and
Environmental Health, Part A, 67: 941–
957. MRID 458677–03.
3. DuPreez L.H., Solomon K.R., Carr
J.A., Giesy J.P., Gross C., R. J. Kendall
et al. 2005. Population Structure
Characterization of Clawed Frog
(Xenopus laevis) in Corn-growing
Versus Non-corn-growing Areas in
South Africa. African Journal of
Herpetology. 54: 61 – 68.
4. Freeman, J.L. and A.L. Rayburn.
2005. Developmental Impact of Atrazine
on Metamorphing Xenopus laevis as
Revealed by Nuclear Analysis and
Morphology. Environmental Toxicology
and Chemistry 24(7): 1648 – 1653.
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17:57 Apr 03, 2007
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5. Forson, D. and A. Storfer. 2005.
Effects of Atrazine and Iridovirus
Infections on Survival and Life-history
Traits of the Long-toed Salamander
(Ambystoma macrodactylum).
Environmental Toxicology and
Chemistry 25(1): 168 – 173.
6. Hayes, T.B. 2004. There is No
Denying This: Defusing the Confusion
about Atrazine. Bioscience 54: 1138 –
1149.
7. Hayes, T.B. 2005. Comment on
‘‘Gonadal Development of Larval Male
Xenopus laevis Exposed to Atrazine in
Outdoor Microcosms.’’ Environmental
Science and Technology 39(19) 7757–
7758.
8. Hayes, T.B. 2005. Welcome to the
Revolution: Integrative Biology and
Assessing the Impact of Endocrine
Disruptors on Environmental and Public
Health. Journal of Integrative and
Comparative Biology 45: 321–329.
9. Hayes T.B., Stuart A.A., Mendoza
M., Collins A., Noriega N., Vonk A.,
Johnston W., Liu R., and D. Kpodzo.
2006. Characterization of AtrazineInduced Gonadal Malformations in
African Clawed Frogs (Xenopus laevis)
and Comparisons with Effects of an
Androgen Antagonist (Cyproterone
Acetate) and Exogenous Estrogen (17-bestradiol): Support for the
Demasculinization/Feminization
Hypothesis. Environmental Health
Perspectives 114: 134 – 141.
10. Jooste A.M., Du Preez L.H., Carr
J.A., Giesy J.P., Gross T.S., Kendall R.J.,
Smith E.E., Van Der Kraak G.J., and K.R.
Solomon. 2004. Gonadal Development
of Larval Male Xenopus laevis Exposed
to Atrazine in Outdoor Microcosms.
Environmental Science and Technology
39: 5255–5261. MRID 458677.
11. Murphy M.B., Hecker M., Coady
K.K., Tompsett A.R., Jones,P.D.,
DuPreez L.H., Solomon K.R., Carr J.A.,
Smith, E.E., Kendall R.J., van der Kraak
G., and J.P. Giesy. 2005. Sediment
TCDD-Eq’s and EROD and MROD
Activities in Ranid Frogs from
Agricultural and Non-agricultural Sites
in Michigan (USA). Archives of
Environmental Contamination and
Toxicology 51(3): 467–477. MRID
458677–02.
12. Murphy, M.B, Hecker M., Coady
K.K., Tompsett A.R., DuPreez L.H.,
Everson G.J., Solomon K.R., Carr J.A.,
Smith E.E., Kendall R.J., van der Kraak
G., and J.P. Giesy. 2005. Atrazine
Concentrations, Gonadal Gross
Morphology, and Histology in Ranid
Frogs Collected in Michigan
Agricultural Areas. Aquatic Toxicology
76: 230–245. MRID 458677–02.
13. Murphy, M. B., Hecker M., Coady
K.K., Tompsett A.R., Higley E.B., Jones
P.D., Du Preez L.H., Solomon K.R., Carr
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16359
J.A., Smith E.E., Kendall R.J., Van Der
Kraak G., and J. P. Giesy. 2006. Plasma
Steroid Hormone Concentrations,
Aromatase Activities and GSI in Ranid
Frogs Collected from Agricultural and
Non-Agricultural Sites in Michigan
(USA). Aquatic Toxicology 77: 153 –
166.
14. Orton, F., Carr J.A., and R. D.
Handy. 2006. Effects of Nitrate and
Atrazine on Larval Development and
Sexual Differentiation in the Northern
Leopard Frog Rana pipiens.
Environmental Toxicology and
Chemistry 25(1): 65 – 71.
15. Smith E.E., Du Preez L.H., Gentles
B.A., Solomon K.R., Tandler B., Carr
J.A., Van Der Kraak G.J., Kendall R.J.,
Giesy J.P. and Gross T.S. 2005.
Assessment of Laryngeal Muscle and
Testicular Cell Types in Xenopus laevis
(Anura Pipidae) Inhabiting Maize and
Non-maize Growing Areas of South
Africa. African Journal of Herpetology
54(1): 69–76. MRID 458677–10.
16. Sullivan K. B, and K. M. Spence.
2003. Effects of Sublethal
Concentrations of Atrazine and Nitrate
on Metamorphosis of the African
Clawed Frog. Environmental Toxicology
and Chemistry 22(3): 627 – 635.
B. What is the Agency’s Authority for
Taking this Action?
EPA is taking action under 7 U.S.C.
136b of the FIFRA.
List of Subjects
Environmental protection, atrazine,
amphibian gonadal development.
Dated: March 29, 2007.
Steve Bradbury,
Director, Environmental Fate and Effects
Division
[FR Doc. E7–6253 Filed 4–3–07; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
Notice of Public Information
Collection(s) Being Submitted for
Review to the Office of Management
and Budget
March 27, 2007.
SUMMARY: The Federal Communications
Commission, as part of its continuing
effort to reduce paperwork burden
invites the general public and other
Federal agencies to take this
opportunity to comment on the
following information collection(s), as
required by the Paperwork Reduction
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agency may not conduct or sponsor a
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Agencies
[Federal Register Volume 72, Number 64 (Wednesday, April 4, 2007)]
[Notices]
[Pages 16357-16359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6253]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2007-0204; FRL-8120-9]
Potential Effects of Atrazine on Amphibian Gonadal Development
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In October 2007, EPA will make a presentation to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory
Panel (SAP) concerning EPA's evaluation of the scientific research
investigating whether exposure to the herbicide atrazine potentially
affects amphibian gonadal development. The scientific research will
include studies that were conducted by Syngenta Crop Protection, Inc.
in 2005 and 2006 as well as published open literature studies. The
notice identifies the open literature studies that EPA has reviewed and
requests public comment to ensure that the list of publications is
complete. The studies that have been reviewed focus on testing atrazine
alone and only on atrazine's potential effects on amphibian gonadal
development.
DATES: Comments must be received on or before May 4, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0204, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-
[[Page 16358]]
0204. EPA's policy is that all comments received will be included in
the docket without change and may be made available on-line at https://
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 regulations.gov or e-mail. The
Federal regulations.gov website 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 regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the 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 docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
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 in the
electronic docket at https://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Thomas Steeger, Environmental Fate and
Effects Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 703-305-5444; fax number: 703-305-7695; e-mail
address: steeger.thomas@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
particular interest to those persons who hold or seek registrations of
pesticide products containing atrazine under FIFRA. This action may
also be of particular interest to those who have published research
regarding the potential effects of atrazine on amphibian gonadal
development. Since other entities may also be interested, EPA has not
attempted to describe all the specific entities that may be affected by
this action. If you have any questions regarding the applicability of
this action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
When submitting comments identifying additional open literature
studies that should be reviewed by EPA, commentors should provide a
complete citation following the format of the studies listed in this
notice. If possible, a copy of the open literature study should be
submitted as well.
II. Background
A. What Action is the Agency Taking?
In April 2002, EPA completed a revised science chapter that
characterized the ecological effects of atrazine in support of an
Interim Reregistration Eligibility Decision (IRED). At about the same
time, scientific articles were published regarding the potential
effects of atrazine on amphibian gonadal development, and concerns were
raised that EPA had not sufficiently accounted for these data in its
risk assessment. In response to an amended consent decree between EPA
and the Natural Resources Defense Council (NRDC), EPA issued an
atrazine IRED in January 31, 2003 which stipulated that EPA would issue
a revised IRED by October 31, 2003. The revised IRED would incorporate
recommendations and comments from a FIFRA Scientific Advisory Panel
(SAP) regarding studies, submitted by February 28, 2003, on the
potential effects of atrazine on amphibians. EPA also agreed to develop
a paper, at least three months prior to signing this revised IRED, and
submit it to the SAP for review and comment.
In accordance with the consent decree, EPA conducted an extensive
review of open literature and registrant-submitted studies concerning
the potential effects of atrazine on amphibian gonadal development.
After a thorough assessment of all of these studies, EPA concluded
there was sufficient information to hypothesize that atrazine exposure
can result in effects on amphibian gonadal development, but there was
insufficient evidence to refute or confirm that hypothesis because the
collective studies failed to show that atrazine produced consistent,
reproducible effects across the range of exposure concentrations and
amphibian species tested in the studies. EPA summarized the studies and
its evaluation of the studies in a White Paper and presented its
analysis, conclusions, and recommendations to the SAP during a meeting
held on June 17 - 20, 2003.
The SAP concurred with EPA's interpretation of the available data
and with EPA's recommendations to seek additional data. Additionally,
the SAP concurred with the study approach described in the White Paper
for addressing uncertainties identified in the available studies. (For
further information regarding this SAP meeting and to obtain a copy of
the White Paper and the SAP's report, refer to https://www.epa.gov/
scipoly/sap/meetings/2003/index.htm#061703.)
In response to the uncertainties identified in the White Paper and
based on the recommendations made by the SAP, EPA issued a Data Call-in
Notice (DCI) on November 12, 2004, to Syngenta Crop Protection, Inc.
(Syngenta) and other atrazine registrants. The DCI required amphibian
studies be conducted to determine if exposure to atrazine can affect
amphibian gonadal development. Secondary objectives of these studies
were to provide information on the repeatability of previous
observations, to develop a sound dose-response relationship, and to
determine the developmental sensitivity of the amphibian species that
are being tested. Syngenta has initiated the studies according to EPA-
approved protocols and expects to submit the final study results to EPA
in 2007.
On October 9 -12, 2007, EPA will return to the SAP with a second
White
[[Page 16359]]
Paper discussing the results of Syngenta's amphibian studies conducted
in 2005 - 2006. In addition, EPA has continued to review the open
literature studies investigating whether atrazine exposure affects
amphibian gonadal development. For this second SAP meeting, EPA plans
to include only those studies that tested atrazine alone and examined
atrazine's potential effects on amphibian gonadal development. Studies
on mixtures of pesticides that include atrazine as well as studies of
the potential for atrazine to cause adverse effects other than or in
addition to amphibian gonadal development are not being considered for
the SAP meeting.
In this Federal Register Notice, EPA is soliciting public comment
on the completeness of its list of open literature studies on the
potential effects of atrazine on amphibian gonadal development. If
other publications relevant to these potential effects are available
and have not been included in this list, EPA requests that citations be
submitted during the comment period. If possible, a copy of the
publication should be submitted as well.
EPA has reviewed the following list of relevant open literature
studies in preparation for the October SAP meeting:
1. Coady K.K., Murphy M.B., Villeneuve D.L., Hecker M., Jones P.D.,
Carr J.A., Solomon K.R., Smith E.E., Van der Kraak G., Kendall R.J.,
and J.P. Giesy. 2004. Effects of Atrazine on Metamorphosis, Growth,
Laryngeal and Gonadal Development, Aromatase Activity, and Plasma Sex
Steroid Concentrations in Xenopus laevis. Ecotoxicology and
Environmental Safety 62:160-173. MRID 458677-04.
2. Coady K.K., Murphy M.B., Villeneuve D.L., Hecker M., Jones P.D.,
Carr J.A., Solomon K.R., Smith E.E., Van der Kraak G., Kendall R.J.,
and J.P. Giesy. 2004. Effects of Atrazine on Metamorphosis, Growth, and
Gonadal Development in the Green Frog (Rana clamitans). Journal of
Toxicology and Environmental Health, Part A, 67: 941-957. MRID 458677-
03.
3. DuPreez L.H., Solomon K.R., Carr J.A., Giesy J.P., Gross C., R.
J. Kendall et al. 2005. Population Structure Characterization of Clawed
Frog (Xenopus laevis) in Corn-growing Versus Non-corn-growing Areas in
South Africa. African Journal of Herpetology. 54: 61 - 68.
4. Freeman, J.L. and A.L. Rayburn. 2005. Developmental Impact of
Atrazine on Metamorphing Xenopus laevis as Revealed by Nuclear Analysis
and Morphology. Environmental Toxicology and Chemistry 24(7): 1648 -
1653.
5. Forson, D. and A. Storfer. 2005. Effects of Atrazine and
Iridovirus Infections on Survival and Life-history Traits of the Long-
toed Salamander (Ambystoma macrodactylum). Environmental Toxicology and
Chemistry 25(1): 168 - 173.
6. Hayes, T.B. 2004. There is No Denying This: Defusing the
Confusion about Atrazine. Bioscience 54: 1138 - 1149.
7. Hayes, T.B. 2005. Comment on ``Gonadal Development of Larval
Male Xenopus laevis Exposed to Atrazine in Outdoor Microcosms.''
Environmental Science and Technology 39(19) 7757-7758.
8. Hayes, T.B. 2005. Welcome to the Revolution: Integrative Biology
and Assessing the Impact of Endocrine Disruptors on Environmental and
Public Health. Journal of Integrative and Comparative Biology 45: 321-
329.
9. Hayes T.B., Stuart A.A., Mendoza M., Collins A., Noriega N.,
Vonk A., Johnston W., Liu R., and D. Kpodzo. 2006. Characterization of
Atrazine-Induced Gonadal Malformations in African Clawed Frogs (Xenopus
laevis) and Comparisons with Effects of an Androgen Antagonist
(Cyproterone Acetate) and Exogenous Estrogen (17-[beta]-estradiol):
Support for the Demasculinization/Feminization Hypothesis.
Environmental Health Perspectives 114: 134 - 141.
10. Jooste A.M., Du Preez L.H., Carr J.A., Giesy J.P., Gross T.S.,
Kendall R.J., Smith E.E., Van Der Kraak G.J., and K.R. Solomon. 2004.
Gonadal Development of Larval Male Xenopus laevis Exposed to Atrazine
in Outdoor Microcosms. Environmental Science and Technology 39: 5255-
5261. MRID 458677.
11. Murphy M.B., Hecker M., Coady K.K., Tompsett A.R., Jones,P.D.,
DuPreez L.H., Solomon K.R., Carr J.A., Smith, E.E., Kendall R.J., van
der Kraak G., and J.P. Giesy. 2005. Sediment TCDD-Eq's and EROD and
MROD Activities in Ranid Frogs from Agricultural and Non-agricultural
Sites in Michigan (USA). Archives of Environmental Contamination and
Toxicology 51(3): 467-477. MRID 458677-02.
12. Murphy, M.B, Hecker M., Coady K.K., Tompsett A.R., DuPreez
L.H., Everson G.J., Solomon K.R., Carr J.A., Smith E.E., Kendall R.J.,
van der Kraak G., and J.P. Giesy. 2005. Atrazine Concentrations,
Gonadal Gross Morphology, and Histology in Ranid Frogs Collected in
Michigan Agricultural Areas. Aquatic Toxicology 76: 230-245. MRID
458677-02.
13. Murphy, M. B., Hecker M., Coady K.K., Tompsett A.R., Higley
E.B., Jones P.D., Du Preez L.H., Solomon K.R., Carr J.A., Smith E.E.,
Kendall R.J., Van Der Kraak G., and J. P. Giesy. 2006. Plasma Steroid
Hormone Concentrations, Aromatase Activities and GSI in Ranid Frogs
Collected from Agricultural and Non-Agricultural Sites in Michigan
(USA). Aquatic Toxicology 77: 153 - 166.
14. Orton, F., Carr J.A., and R. D. Handy. 2006. Effects of Nitrate
and Atrazine on Larval Development and Sexual Differentiation in the
Northern Leopard Frog Rana pipiens. Environmental Toxicology and
Chemistry 25(1): 65 - 71.
15. Smith E.E., Du Preez L.H., Gentles B.A., Solomon K.R., Tandler
B., Carr J.A., Van Der Kraak G.J., Kendall R.J., Giesy J.P. and Gross
T.S. 2005. Assessment of Laryngeal Muscle and Testicular Cell Types in
Xenopus laevis (Anura Pipidae) Inhabiting Maize and Non-maize Growing
Areas of South Africa. African Journal of Herpetology 54(1): 69-76.
MRID 458677-10.
16. Sullivan K. B, and K. M. Spence. 2003. Effects of Sublethal
Concentrations of Atrazine and Nitrate on Metamorphosis of the African
Clawed Frog. Environmental Toxicology and Chemistry 22(3): 627 - 635.
B. What is the Agency's Authority for Taking this Action?
EPA is taking action under 7 U.S.C. 136b of the FIFRA.
List of Subjects
Environmental protection, atrazine, amphibian gonadal development.
Dated: March 29, 2007.
Steve Bradbury,
Director, Environmental Fate and Effects Division
[FR Doc. E7-6253 Filed 4-3-07; 8:45 am]
BILLING CODE 6560-50-S