Pesticide Experimental Use Permit; Receipt of Amendment Application; ...

Tag : pesticide

Released : Wednesday, October 08, 2008 12:43 PM
ENVIRONMENTAL PROTECTION AGENCY (EPA)
Notice.
Citation: "73 FR 58954"
Document Number: "EPA-HQ-OPP-2007-0179; FRL-8384-3"
Page Number: "58954"
"Notices"
SUMMARY: This notice announces EPA's receipt of an application264-EUP-140 from Bayer CropScience requesting to amend and extendthe existing an experimental use permit (EUP) for the Bacillusthuringiensis Cry1Ab protein and the genetic material necessary forits production in event T303-3 and T304-40 cotton plants. TheAgency has determined that the permit may be of regional andnational significance. Therefore, in accordance with 40 CFR172.11(a), the Agency is soliciting comments on this application.
DATES: Comments must be received on or before November 7, 2008.
ADDRESSES: Submit your comments, identified by docketidentification (ID) number EPA-HQ-OPP-2007-0179, by one of thefollowing methods:
* Federal eRulemaking Portal: http://www.regulations.gov.Follow the on-line instructions for submitting comments.
* Mail: Office of Pesticide Programs (OPP) Regulatory PublicDocket (7502P), Environmental Protection Agency, 1200 PennsylvaniaAve., NW., Washington, DC 20460-0001.
* Delivery: OPP Regulatory Public Docket (7502P), EnvironmentalProtection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777S. Crystal Dr., Arlington,VA. Deliveries are only accepted duringthe Docket Facility's normal hours of operation (8:30 a.m. to 4p.m., Monday through Friday, excluding legal holidays). Specialarrangements should be made for deliveries of boxed information.The Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID numberEPA-HQ-OPP-2007-0179. EPA's policy is that all comments receivedwill be included in the docket without change and may be madeavailable on-line at http://www.regulations.gov, including anypersonal information provided, unless the comment includesinformation claimed to be Confidential Business Information (CBI)or other information whose disclosure is restricted by statute. Donot submit information that you consider to be CBI or otherwiseprotected through regulations.gov or e-mail. The regulations.govwebsite is an "anonymous access" system, which means EPA will notknow your identity or contact information unless you provide it inthe body of your comment. If you send an e-mail comment directly toEPA without going through regulations.gov, your e-mail address willbe automatically captured and included as part of the comment thatis placed in the docket and made available on the Internet. If yousubmit an electronic comment, EPA recommends that you include yourname and other contact information in the body of your comment andwith any disk or CD-ROM you submit. If EPA cannot read your commentdue to technical difficulties and cannot contact you forclarification, EPA may not be able to consider your comment.Electronic files should avoid the use of special characters, anyform of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docketindex available at http://www.regulations.gov. Although listed inthe index, some information is not publicly available, e.g., CBI orother information whose disclosure is restricted by statute.Certain other material, such as copyrighted material, is not placedon the Internet and will be publicly available only in hard copyform. Publicly available docket materials are available either inthe electronic docket at http://www.regulations.gov, or, if onlyavailable 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 arefrom 8:30 a.m. to 4 p.m., Monday through Friday, excluding legalholidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticidesand Pollution Prevention Division (7511P), Office of PesticidePrograms, Environmental Protection Agency, 1200 Pennsylvania Ave.,NW., Washington, DC 20460-0001; telephone number: (703) 308-8263;e-mail address: greenway.denise@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This actionmay, however, be of interest to those persons who are interested inagricultural biotechnology or may be required to conduct testing ofpesticidal substances under the Federal Food, Drug, and CosmeticAct (FFDCA) or the Federal Insecticide, Fungicide, and RodenticideAct (FIFRA). Since other entities may also be interested, theAgency has not attempted to describe all the specific entities thatmay be affected by this action. If you have any questions regardingthe applicability of this action to a particular entity, consultthe 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 throughregulations.gov or e-mail. Clearly mark the part or all of theinformation that you claim to be CBI. For CBI information in a diskor CD-ROM that you mail to EPA, mark the outside of the disk orCD-ROM as CBI and then identify electronically within the disk orCD-ROM the specific information that is claimed as CBI. In additionto one complete version of the comment that includes informationclaimed as CBI, a copy of the comment that does not contain theinformation claimed as CBI must be submitted for inclusion in thepublic docket. Information so marked will not be disclosed exceptin 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 otheridentifying information (subject heading, Federal Register date andpage number).
ii. Follow directions. The Agency may ask you to respond tospecific questions or organize comments by referencing a Code ofFederal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives andsubstitute language for your requested changes.
iv. Describe any assumptions and provide any technicalinformation and/or data that you used.
v. If you estimate potential costs or burdens, explain how youarrived at your estimate in sufficient detail to allow for it to bereproduced.
vi. Provide specific examples to illustrate your concerns andsuggest alternatives.
vii. Explain your views as clearly as possible, avoiding the useof profanity or personal threats.
viii. Make sure to submit your comments by the comment perioddeadline identified.
3. Environmental justice. EPA seeks to achieve environmentaljustice, the fair treatment and meaningful involvement of anygroup, including minority and/or low income populations, in thedevelopment, implementation, and enforcement of environmental laws,regulations, and policies. To help address potential environmentaljustice issues, the Agency seeks information on any groups orsegments of the population who, as a result of their location,cultural practices, or other factors, may have atypical ordisproportionately high and adverse human health impacts orenvironmental effects from exposure to the pesticide(s) discussedin this document, compared to the general population.
II. What Action is the Agency Taking?
Under section 5 of FIFRA, 7 U.S.C. 136c, EPA can allowmanufacturers to field test pesticides under development.Manufacturers are required to obtain an EUP before testing newpesticides or new uses of pesticides if they conduct experimentalfield tests on 10 acres or more of land or one acre or more ofwater.
Pursuant to 40 CFR 172.11(a), the Agency has determined that thefollowing EUP application may be of regional and nationalsignificance, and therefore is seeking public comment on the EUPapplication:
Submitter: Bayer CropScience, (264-EUP-140).
Pesticide Chemical: Bacillus thuringiensis Cry1Ab protein andthe genetic material necessary for its production in event T303-3and T304-40 cotton plants.
Summary of Request: Bayer CropScience has requested an amendmentand extension of EUP 264-EUP-140, which was first granted by EPA onFebruary 7, 2006 (71 FR 41020; July 19, 2006; FRL-8060-6) and wasamended on March 8, 2007 (72 FR 34009; June 20, 2007; FRL-8133-5)and on August 28, 2008 (a separate document is published elsewherein this Federal Register). Under the existing EUP, plantings arepermitted through January 31, 2009. Bayer CropScience is nowproposing to amend the experimental program by conducting testingon 152 acres (out of 1,602 total acres) planted toCry1Ab-containing cotton, with up to 0.03 pound of Cry1Ab proteinand the genetic material necessary for its production in eventsT303-3 and T304-40; and to extend the amended program to run fromJanuary 1, 2009 until December 31, 2010. The Cry1Ab protein iseffective in controlling lepidopteran larvae such as bollworm(Helicoverpa zea) and tobacco budworm (Heliothis virescens), whichare common pests of cotton. The proposed program will be carriedout in the States of Alabama, Arizona, Arkansas, California,Florida, Georgia, Louisiana, Mississippi, North Carolina, SouthCarolina, Tennessee, Texas, and in Puerto Rico. The proposedexperimental program includes trials to evaluate insect andherbicide efficacy and agronomic performance. Also proposed is theproduction of sample material for regulatory studies and seedproduction for future experimental field trial plantings.
A copy of the application and any information submitted isavailable for public review in the docket established for this EUPapplication as described under ADDRESSES.
Following the review of the application and any comments anddata received in response to this solicitation, EPA will decidewhether to issue or deny the EUP request, and if issued, theconditions under which it is to be conducted. Any issuance of anEUP will be announced in the Federal Register .
List of Subjects
Environmental protection, Experimental use permits.
Dated: September 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Officeof Pesticide Programs.
[FR Doc. E8-23860 Filed 10-7-08; 8:45 am]
BILLING CODE 6560-50-S
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Provider:
Federal Information & News Dispatch, Inc. / Federal Register
Keywords:
Agriculture , Food & Beverage , Agriculture , Food & Beverage Regulatory , Agrochemicals , Agriculture Regulatory , Bayer , Business Management , U.S. Business News , Business News , Chemicals , Environmental Solutions , Americas Environmental , Environmental