E9-31283. Bacillus subtilis; Registration Review Proposed Decision; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 [phone].

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 [phone].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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: [phone]; fax number: [phone]; e-mail address: [e-mail].

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 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,

Dated: December 23, 2009.

Keith D. Matthews,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.