Environmental Protection Agency (EPA).
This notice announces EPA's proposed determination to terminate the Special Review of oxydemeton-methyl (ODM). On October 5, 1987, in the Federal Register, EPA initiated a Special Review of ODM because of its potential to adversely affect reproduction of workers who mix, load, and apply products containing ODM. Since the initiation of the Special Review, additional data and more comprehensive reviews of potential risks associated with ODM exposure have been completed, including those described in the 2002 Interim Reregistration Eligibility Decision (IRED) for ODM. During the reregistration process EPA conducted a public, intensive review of ODM risks. In the 2002 IRED and subsequent label amendments, the Agency addressed the occupational risk concerns, including risks associated with potential reproductive effects. There continues to be evidence of reproductive effects; however, there is no evidence that these effects inhibit the ability of organisms to reproduce. Similarly, further data and analysis have addressed the concern for heritable effects. With the label amendments that have been made since the initiation of Special Review, ODM exposure is expected to be below the levels where any reproductive effects occur. Because the risks that were the basis of the Special Review are no longer of concern, the Agency is proposing to terminate the Special Review of ODM.
Comments must be received on or before September 7, 2007.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2007-0436, 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 Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2007-0436. 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 Facility telephone number is (703) 305-5805.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Richard P. Dumas, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; fax number: (703) 308-8005; e-mail address: firstname.lastname@example.org.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 interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency 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?
1. Submitting CBI. Do not submit this information to EPA through 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 Start Printed Page 44519CD 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.
A. What Action is the Agency Taking?
On October 5, 1987, (52 FR 37248; FRL-3273-1) EPA initiated a Special Review of oxydemeton-methyl (ODM) because of its potential to adversely affect reproduction of workers who mix, load, and apply products containing ODM. The Agency's concerns regarding reproductive effects were based primarily on the results of a two-generation rat reproduction study and interim progress reports from an ongoing male rat reproductive toxicity study. Observed reproductive effects were decreased parental body weight, parental testes weight and fertility index, vacuolation of the corpus epididymus, decreased litter size, decreased pup weight and increased pup mortality.
Since the initiation of the Special Review, additional data and more comprehensive reviews of potential risks associated with ODM exposure have been completed, including those described in the 2002 Interim Reregistration Eligibility Decision (IRED) for ODM. In addition, during the reregistration process EPA conducted an intensive and public review of whether or not ODM registrations, meet the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) standard for registration. In the 2002 IRED and subsequent label amendments, the Agency addressed the occupational risk concerns, including risk associated with potential reproductive effects. There continues to be evidence of reproductive effects; however, there is no evidence that these effects inhibit the ability of organisms to reproduce. Similarly, further data and analysis have addressed the concern for heritable effects. With the label amendments that have been made since the initiation of Special Review, ODM exposure is expected to be below the levels where any reproductive effects occur. Because the risks that were the basis of the Special Review are no longer of concern, the Agency is proposing to terminate the Special Review of ODM.
The final risk management decision regarding the risk to workers exposed to ODM was completed with the 2002 IRED. A detailed description of the rationale and supporting documents can be found in http://www.regulations.gov under EPA-HQ-OPP-2005-0281. As described above and in the 2002 IRED, concerns regarding reproductive effects were addressed under FIFRA and no further action is required at this time. As such, EPA is proposing to terminate the Special Review of ODM.
B. What is the Agency's Authority for Taking this Action?
A pesticide product may be sold or distributed in the United States only if it is registered or exempt from registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended (7 U.S.C. 136 et seq.). Before a product can be registered it must be shown that it can be used without causing “unreasonable adverse effects on the environment,” FIFRA section 3(c)(5). The term “unreasonable adverse effects on the environment” is defined in FIFRA section 2(bb) as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” The burden of proving that a pesticide meets this standard for registration is, at all times, on the proponent of initial or continued registration. If at any time the Agency determines that a pesticide no longer meets this standard, the Administrator may cancel this registration under section 6 of FIFRA.
The Special Review process provides a mechanism to permit public participation in EPA's deliberations prior to issuance of any Notice of Final Determination describing the regulatory action which the Administrator has selected. The Special Review process, which was previously called the Rebuttable Presumption Against Registration (RPAR), is described in 40 CFR part 154, published in the Federal Register of November 27, 1985 (50 FR 49003, 49015; FRL 2914-6). The purpose of this process is to determine whether some or all registrations of a particular active ingredient or ingredients meet the FIFRA standard for registration, or whether amendment of the terms and conditions of registration or cancellation of portions or all of the registrations is appropriate.
Prior to formal initiation of a Special Review, a preliminary notification is sent to registrants and applicants for registration pursuant to 40 CFR 154.21 announcing that the Agency is considering commencing a Special Review. Registrants and applicants for registration are allowed 30 days from receipt of the notification to comment on the Agency's proposal to commence a Special Review.
If the Agency determines, after issuance of a notification pursuant to 40 CFR 154.21, that it will initiate a Special Review, 40 CFR 154.23(c) requires the Administrator to publish a Notice of Special Review in the Federal Register. To conclude the Special Review after a Special Review has been initiated, 40 CFR 154.31 requires the Administrator to first publish a Notice of Preliminary Determination in the Federal Register. This Notice concerning the ODM is being issued pursuant to 40 CFR 154.31.
That regulation requires the Administrator to respond to all significant comments received on the Notice of Special Review and, among other things, make a preliminary determination of whether any of the applicable risk criteria have been satisfied. Finally, after receipt and evaluation of comments on the Notice of Preliminary Determination, 40 CFR 154.33 requires that the Administrator publish in the Federal Register a Notice of Final Determination, including the reasons for the determination.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: July 30, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.
[FR Doc. E7-15113 Filed 8-7-07; 8:45 am]
BILLING CODE 6560-50-S