[Federal Register Volume 75, Number 3 (Wednesday, January 6, 2010)]
[Notices]
[Pages 862-864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31283]
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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: [email protected].
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:
[email protected].
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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