Document ID: EPA-HQ-OPP-2007-1026-0014
Agency: epa
Document Type: Notice
Title: Bacillus subtilis; Registration Review Proposed Decision; Notice of Availability
Posted Date: 2010-01-06T05:00Z

[Federal Register: January 6, 2010 (Volume 75, Number 3)]
[Notices]               
[Page 862-864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja10-38]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-1026; FRL-8804-5]

 
Bacillus subtilis; Registration Review Proposed Decision; Notice 
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's proposed 
registration review decision for the pesticide Bacillus subtilis (case 
6012) and opens a public comment period on the proposed decision. 
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, that the pesticide can perform its 
intended function without unreasonable adverse effects on human health 
or the environment. 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 February 28, 2010.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2007-1026 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 Facility'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 identification (ID) 
number EPA-HQ-OPP-2007-1026. 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 http://www.regulations.gov. 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 for 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.

[[Page 863]]

FOR FURTHER INFORMATION CONTACT: For pesticide specific information, 
contact: The Regulatory Action Leader (RAL) Susanne Cerrelli, 
Biopesticides and Pollution Prevention Division (7511P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8077; 
fax number: (703) 308-7026; e-mail address: cerrelli.susanne@epa.gov.
    For general information on the registration review program, 
contact: Kevin Costello, Pesticide Re-evaluation 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, farm workers; 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 regulatory action leader 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 on 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. Background

A. What Action is the Agency Taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability 
of EPA's proposed registration review decision Bacillus subtilis (case 
6012). The Bacillus subtilis case consists of four strains: Strain 
GB03; Strain MBI 600; Strain QST 713; and var. amyloliquefaciens Strain 
FZB24. All four strains occur ubiquitously in the environment:
    Bacillus subtilis strain GB03 is used to prevent, control and 
suppress plant disease on barley, berries, bulb vegetables, cole crops, 
cotton, cucurbits, fruiting vegetables, herbs, leafy crops, legumes, 
ornamental plants and cuttings, peanuts, root/tuber and corm 
vegetables, soybeans, tomatoes, trees, tropical plants, turf, and 
wheat. Bacillus subtilis strain GB03 is applied as a irrigation 
application, pre-plant soak, overhead spray, soil drench, seed 
dressing, tank mix, or hydroponic system treatment;
    Bacillus subtilis strain MBI 600 is used to suppress disease 
organisms such as Botrytis, Alternaria, Rhizoctonia, and Fusarium and 
is also used to promote more effective nodulation by nitrogen-fixing 
bacteria to improve yields. It is used as a seed and in-furrow 
treatment on cotton, seed and pod vegetables, peanuts, soybeans, 
alfalfa, forage and turf grasses, wheat, barley, corn, and canola. It 
is also used in greenhouses to treat peat moss and soil intended for 
seeding, potting, or transplanting non-bearing fruit and vegetable 
seedlings and as a foliar spray on asparagus, cole crops, bulb 
vegetables, berry crops, cucurbits, flowers, bedding plants, 
ornamentals, tropical plants, fruiting vegetables, grape, leafy 
vegetables, pome fruit, stone fruit, strawberry, tuber/root and corm 
vegetables, turf, sod, lawns, trees, and shrubs;
    Bacillus subtilis strain QST 713 is used to prevent or reduce 
several types of fungal and bacterial pests on artichoke, asparagus, 
avocado, beans, beets, berries, brassica crops, bulb vegetables, 
celery, cereal grains, citrus, coffee, corn, cucurbits, beans, 
eggplant, grapes, herbs/spices, hops, kiwi, kohlrabi, leafy vegetables, 
legumes, melons, oil seed crops, oil palm, okra, peanuts, peppers, pome 
fruit, rice, root/tuber crops, silage crops, stone fruits, tomatoes, 
tree nuts, tropical fruits, field roses, forestry seedlings, lawns, 
ornamental flowering plants, ornamental foliage plants, ornamental 
trees and shrubs, seed production crops, sod, tobacco, and turf;
    Bacillus subtilis var. amyloliquefaciens strain FZB24 is used for 
plant strengthening, enhancing growth, increasing yields and 
suppressing soil-borne fungal diseases such as Rhizoctonia and Fusarium 
as a dip for seedlings, transplants, plugs, tubers, bulbs, corms, 
cuttings and roots of ornamentals, shrubs and trees, and as a spray 
over furrows for ornamentals, shrubs, trees, turf, vegetables, herbs 
and spices, and other crops. It is also incorporated into soils, soil-
less growing media and mushroom spawn media and as a drench for 
interiorscapes and potted orchids and ferns.
    The registration review docket for a pesticide includes earlier 
documents related to the registration review of the case. For example, 
the review opened with the posting of a Summary Document, containing a 
Preliminary Work Plan for public comment. A Final Work Plan was posted 
to the docket following public comment on the initial docket.
    The documents in the docket describe EPA's rationales for 
conducting additional risk assessments for the registration review of 
Bacillus subtilis, as well as the Agency's subsequent risk findings. 
This proposed registration review decision is supported by the 
rationales included in those documents.
    Following public comment, the Agency will issue a final 
registration review decision for products containing Bacillus subtilis.
    The registration review program is being conducted under 
congressionally mandated time frames. EPA recognizes the need both to 
make timely decisions

[[Page 864]]

and to involve the public. Section 3(g) of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended, required EPA to 
establish, by regulation, procedures for reviewing pesticide 
registrations, originally with a goal of reviewing each pesticide's 
registration every 15 years to ensure that a pesticide continues to 
meet the FIFRA standard for registration. The Agency's final rule to 
implement this program was issued in August 2006, became effective in 
October 2006, and appears at 40 CFR part 155, subpart C. The Pesticide 
Registration Improvement Act of 2003 (PRIA) was amended and extended in 
September 2007. FIFRA, as amended by PRIA in 2007, requires EPA to 
complete registration review decisions by October 1, 2022, for all 
pesticides registered as of October 1, 2007.
    The registration review final rule at 40 CFR 155.58(a) provides for 
a minimum 60-day public comment period on all proposed registration 
review decisions. This comment period is intended to provide an 
opportunity for public input and a mechanism for initiating any 
necessary amendments to the proposed decision. All comments should be 
submitted using the methods in ADDRESSES, and must be received by EPA 
on or before the closing date. These comments will become part of the 
docket for Bacillus subtilis. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments.
    The Agency will carefully consider all comments received by the 
closing date and will provide a ``Response to Comments Memorandum'' in 
the docket. The final registration review decision will explain the 
effect that any comments had on the decision and provide the Agency's 
response to significant comments.
    Background on the registration review program is provided at: 
http://www.epa.gov/oppsrrd1/registration_review. Links to earlier 
documents related to the registration review of this pesticide are 
provided at: http:/www.epa.gov/oppsrrd1/registration_review/bacillus_
subtilis/index.htm.

B. What is the Agency's Authority for Taking this Action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide 
authority for this action.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Pesticides and pests, Bacillus subtilis.

    Dated: December 23, 2009.
Keith D. Matthews,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

[FR Doc. E9-31283 Filed 1-5-10; 8:45 am]

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