
[Federal Register: September 24, 2008 (Volume 73, Number 186)]
[Notices]               
[Page 55076-55078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se08-91]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP- 2007-0994; FRL-8381-7]

 
Registration Review; Azadirachtin Docket Opened for Review and 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established a registration review docket for the 
pesticide listed in the table in Unit III.A. With this document, EPA is 
opening the public comment period for this registration review. 
Registration review is EPA's periodic review of pesticide registrations 
to ensure that each pesticide continues to satisfy the statutory 
standard for registration, that is, the pesticide can perform its 
intended function without unreasonable adverse effects on human health 
or the environment. Registration review dockets contain information 
that will assist the public in understanding the types of information 
and issues that the Agency may consider during the course of 
registration reviews. Through this program, EPA is ensuring that each 
pesticide's registration is based on current scientific and other 
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before November 24, 2008.

ADDRESSES: Submit your comments identified by the docket identification 
(ID) number for the specific pesticide of interest provided in the 
table in Unit III.A., 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 the docket ID number listed 
in the table in Unit III.A. for the pesticides you are commenting on. 
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 
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

[[Page 55077]]

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 at 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 
website 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 electronically 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.

FOR FURTHER INFORMATION CONTACT: For information about the pesticides 
included in this document, contact the specific Regulatory Action 
Leader (RAL) as identified in the table in Unit III.A. for the 
pesticide of interest.
    For general questions on the registration review program, contact 
Kevin Costello, Special Review and Reregistration Division (7508P), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-5026; fax number: (703) 308-8090; e-mail address: 
costello.kevin@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 
interest to a wide range of stakeholders including environmental, human 
health, farmworker, 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.

II. Authority

    EPA is initiating its review of the pesticide identified in this 
document pursuant to section 3(g) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations 
for Registration Review at 40 CFR part 155, subpart C. Section 3(g) of 
FIFRA provides, among other things, that the registrations of 
pesticides are to be periodically reviewed. The goal is a review of a 
pesticide's registration every 15 years. Under FIFRA section 3(a), a 
pesticide product may be registered or remain registered only if it 
meets the statutory standard for registration given in FIFRA section 
3(c)(5). When used in accordance with widespread and commonly 
recognized practice, the pesticide product must perform its intended 
function without unreasonable adverse effects on the environment; that 
is, without any unreasonable risk to man or the environment, or a human 
dietary risk from residues that result from the use of a pesticide in 
or on food.

III. Registration Reviews

 A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is periodically reviewing 
pesticide registrations to assure that they continue to satisfy the 
FIFRA standard for registration--that is, they can still be used 
without unreasonable adverse effects on human health or the 
environment. The implementing regulations establishing the procedures 
for registration review appear at 40 CFR part 155. A pesticide's 
registration review begins when the Agency establishes a docket for the 
pesticide's registration review case and opens the docket for public 
review and comment. At present, EPA is opening registration review 
dockets for the cases identified in the following table.

[[Page 55078]]



                Table--Registration Review Docket Opening
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                                                        Chemical Review
  Registration Review Case Name    Pesticide Docket     Manager (RAL),
           and Number                  ID Number       Telephone Number,
                                                        E-mail Address
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Azadirachtin                      EPA-HQ-OPP-2008-06  Leonard Cole
                                   32                 (703) 305-5412
                                                      cole.leonard@epa.g
                                                       ov
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 B. Docket Content

    1. Review dockets. The registration review dockets contain 
information that the Agency may consider in the course of the 
registration review. The Agency may include information from its files 
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending 
registration actions.
     Federal Register notices regarding current or pending 
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
     Each docket contains a document summarizing what the Agency 
currently knows about the pesticide case and a preliminary work plan 
for anticipated data and assessment needs. Additional documents provide 
more detailed information. During this public comment period, the 
Agency is asking that interested persons identify any additional 
information they believe the Agency should consider during the 
registration reviews of these pesticides. The Agency identifies in each 
docket the areas where public comment is specifically requested, though 
comment in any area is welcome.
    2. Other related information. More information on these cases, 
including the active ingredients for each case, may be located in the 
registration review schedule on the Agency's website at http://
www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on 
the Agency's registration review program and its implementing 
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_
review.
     3. Information submission requirements. Anyone may submit data or 
information in response to this document. To be considered during a 
pesticide's registration review, the submitted data or information must 
meet the following requirements:
     To ensure that EPA will consider data or information 
submitted, interested persons must submit the data or information 
during the comment period. The Agency may, at its discretion, consider 
data or information submitted at a later date.
     The data or information submitted must be presented in a 
legible and useable form. For example, an English translation must 
accompany any material that is not in English and a written transcript 
must accompany any information submitted as an audiographic or 
videographic record. Written material may be submitted in paper or 
electronic form.
     Submitters must clearly identify the source of any 
submitted data or information.
     Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
     As provided in 40 CFR 155.58, the registration review 
docket for each pesticide case will remain publicly accessible through 
the duration of the registration review process; that is, until all 
actions required in the final decision on the registration review case 
have been completed.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: September 18, 2008.
 Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. E8-22387 Filed 9-23-08; 8:45 am]

BILLING CODE 6560-50-S
