Environmental Protection Agency (EPA).
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.
Comments must be received on or before May 4, 2007.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0204, by one of the following methods:
- Federal eRulemaking Portal: http://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-Start Printed Page 163580204. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line 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 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 http://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 http://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.Start Further Info
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: email@example.com.End Further Info End Preamble Start Supplemental 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.
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 http://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 Start Printed Page 16359Paper 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-β-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.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: March 29, 2007.
Director, Environmental Fate and Effects Division
[FR Doc. E7-6253 Filed 4-3-07; 8:45 am]
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