Document ID: EPA-HQ-OPP-2007-1026-0001
Agency: epa
Document Type: Notice
Title: Registration Review; Biopesticide Dockets Opened for Review and Comment
Posted Date: 2008-03-28T04:00Z

[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]               
[Page 16677-16679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr08-76]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1026; FRL-8354-5]

 
Registration Review; Biopesticide Dockets Opened for Review and 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established registration review dockets for the 
pesticides listed in the table in Unit III.A. With this document, EPA 
is opening the public comment period for these registration reviews. 
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. 
This document also announces the Agency's intent not to open a 
registration review docket for thyme herbs and ground sesame plant. 
These pesticides do not currently have any active federally registered 
pesticide products and are not, therefore, scheduled for review under 
the registration review program.

DATES: Comments must be received on or before May 27, 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 numbers 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 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 
Peter Caulkins, Special Review and Reregistration Division (7508P), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(703) 305-6550; fax number: (703) 308-8090; e-mail address: 
caulkins.peter@epa.gov.

SUPPLEMENTARY INFORMATION:

[[Page 16678]]

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 reviews of the pesticides 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.

              Table 1.--Registration Review Dockets Opening
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                                                       [RAL], Telephone
  Registration Review Case Name    Pesticide Docket     Number, E-mail
           and Number                  ID Number            Address
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Bacillus subtilis, Case no. 6012  EPA-HQ-OPP-2007-10  Susanne Cerrelli,
                                   26                 (703) 308-8077,
                                                      cerrelli.susanne@e
                                                       pa.gov
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    EPA is also announcing that it will not be opening a docket for 
registration review case 6060, thyme herbs and ground sesame plant 
because these pesticides are not included in any products actively 
registered under FIFRA section 3. The last federally registered thyme 
herbs (PC Code 128894) and ground sesame plant (PC Code 128970) 
products were cancelled for non-payment of the required annual 
maintenance fees of 2005 and 2006, respectively (August 3, 2005; 70 FR 
44637; FRL-7726-4 and August 2, 2006; 71 FR 43748; FRL-8079-6).
    Products containing either thyme herbs or ground sesame stalk as 
the active ingredient, when in accordance with all of the criteria of 
40 CFR 152.25(f), are `minimum risk pesticides' exempt from the 
requirements of FIFRA. The Federal Food, Drug, and Cosmetics Act 
(FFDCA) coverage necessary for any 40 CFR 152.25(f)-compliant thyme 
herbs or ground sesame plant food-use product is provided by the 
exemption from the requirement of a tolerance under 40 CFR 180.950 for 
spices and herbs, and by the sesame stalks tolerance exemption under 40 
CFR 180.1087. The tolerance exemption under 40 CFR 180.950 was 
established in 2002, and that at 40 CFR 180.1087 was reassessed in 
2002; both have been determined to meet the safety standards of the 
FFDCA, as amended by the FQPA of 1996.
    The Agency requires no further risk assessments or submission of 
data for the uses of thyme herbs and ground sesame plant when these 
active ingredients are used in a manner compliant with 40 CFR 
152.25(f).
    The Agency will take separate actions to cancel any remaining FIFRA 
section 24(c) Special Local Needs registrations with these or any other 
active ingredient in this docket and to propose revocation of any 
affected tolerances that are not supported for import purposes only.

[[Page 16679]]

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:
    i. An overview of the registration review case status.
    ii. A list of current product registrations and registrants.
    iii. Federal Register notices regarding any pending registration 
actions.
    iv. Federal Register notices regarding current or pending 
tolerances.
    v. Risk assessments.
    vi. Bibliographies concerning current registrations.
    vii. Summaries of incident data.
    viii. 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:
    i. 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.
    ii. 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.
    iii. Submitters must clearly identify the source of any submitted 
data or information.
    iv. 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.
    v. 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: March 19, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.
[FR Doc. E8-6394 Filed 3-27-08; 8:45 am]

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