Environmental Protection Agency (EPA).
This document announces the availability of objections filed with respect to the establishment of two boscalid tolerances under section 408 of the Federal Food, Drug, and Cosmetic Act. The objections were filed on February 20, 2007 by the Natural Resources Defense Council (“NRDC”). NRDC's objections assert that EPA unlawfully removed the additional 10X safety factor for the protection of infants and children. Additionally NRDC claims that EPA's action was arbitrary and capricious for failing to provide an adequate explanation for the decision on the children's safety factor. This document seeks comment on the NRDC objections.
Comments must be received on or before May 29, 2007.
Submit your comments, identified by docket identification (ID) number(s) EPA-HQ-OPP-2005-0145, 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(s) EPA-HQ-OPP-2005-0145. 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: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0145. 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. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (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 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 Docket Facility is open 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:
Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, Start Printed Page 14552DC 20460-0001; telephone number: (703) 305-6463; fax number: (703) 605-0781; 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 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.
A. What Action is the Agency Taking?
On February 20, 2007, the Natural Resources Defense Council (“NRDC”) filed objections to a final rule establishing tolerances for the pesticide boscalid on two crop subgroups in the leafy vegetables crop group. (December 20, 2006 (71 FR 76185; FRL-8107-8)). Pesticide tolerances are established under section 408 of the Federal Food, Drug, and Cosmetic Act (“FFDCA”). (21 U.S.C. 346a). The new tolerances were for Crop Subgroup 4A, leafy greens except head and leaf lettuce, and Crop Subgroup 4B, leafy petioles.
NRDC's objections assert that it was unlawful for EPA to remove the additional 10X safety factor for the protection of infants and children in assessing the risk of boscalid because the evidence shows that juveniles are more sensitive to boscalid than adults. NRDC claims that if the 10X children's safety factor is retained, the boscalid tolerances do not meet the safety standard for establishing tolerances under FFDCA section 408. Additionally, NRDC argues that EPA's action was arbitrary and capricious for failing to provide an adequate explanation for the decision on the children's safety factor.
Because the issues raised by NRDC concern matters of great interest not just to NRDC but to growers, food distributors and processors, and pesticide manufacturers as well as members of the public, EPA believes it decision-making will be enhanced by obtaining the views of all affected parties. For that reason, EPA is publishing this notice of availability of NRDC's objections and requesting comment on the objections. The objections are available in the docket for the tolerance rule in question, i.e., Docket EPA-HQ-OPP-2005-0145. See the “ADDRESSES” section of this document for information accessing the docket.
B. What is the Agency's Authority for Taking this Action?
Under section 408(g)(2)(A) of the FFDCA, any person may file objections with EPA within 60 days of issuance of a final tolerance regulation. (21 U.S.C. 346a(g)(2)). Such person may also request a public evidentiary hearing on the objections; however, NRDC has not requested such a hearing. Under EPA regulations, EPA must publish an order setting forth its determination on each of NRDC's objections. (40 CFR 178.37(a)). Such order must contain EPA's reasons for its determination. (40 CFR 178.37(b)). If based on the objections EPA determines that the tolerance regulation should be modified or revoked, EPA will publish by order any revisions to the regulation. (21 U.S.C. 346a(g)(2)(C); 40 CFR 178.35).Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: March 14, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E7-5576 Filed 3-27-07; 8:45 am]
BILLING CODE 6560-50-S