Bacillus pumilus Strain QST 2808; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.

DATES:

Comments, identified by docket ID number OPP-2004-0105, must be received on or before June 4, 2004.

ADDRESSES:

Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Susanne Cerrelli, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8077; e-mail address: cerrelli.susanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer.

Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturer (NAICS 311)
• Pesticide manufacturer (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2004-0105. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.

For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.

Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.

1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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.

i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/ , and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in docket ID number OPP-2004-0105. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.

ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID number OPP-2004-0105. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.

2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0105.

3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP-2004-0105. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.

List of Subjects

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Summary of Petition

The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by AgraQuest, Inc. and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.

AgraQuest, Inc.

PP 4F6826

EPA has received a pesticide petition (PP 4F6826) from AgraQuest, Inc., 1530 Drew Ave., Davis, CA 95616, proposing pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of Sonata^TM ASO, which contains the QST 2808 strain of Bacillus pumilus, to control various plant diseases such as downy mildew, powdery mildew, Phytophthera, Sclerotinia, Cercospora, and/or rust on the following vegetable crop groups: Brassica, bulb, cucurbits, fruiting, leafy, legume, and root and tuber; on the following fruit crop groups: pome and stone; on the grain, cereal, group; and the following individual crops: grape, grasses grown for seed, hop, mint, peanuts, strawberry, sweet corn, tobacco, field grown roses, and certain trees. The product is applied as a foliar spray alone, in alternating spray programs, or in tank mixes with other registered crop protection products, up to and including the day of harvest. Sonata^TM ASO may be applied with spray equipment commonly used for making ground or aerial applications. Thorough coverage is essential for optimum disease control.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Sonata^TM ASO contains the QST 2808 strain of Bacillus pumilus as the active ingredient. Bacillus pumilus strain QST 2808 is a ubiquitous, naturally occurring, non-pathogenic microorganism. It is commonly recovered from water, soil, air, and decomposing plant residue. Bacillus pumilus produces proteases and other enzymes that enable it to degrade a variety of natural substrates and contribute to nutrient recycling. Bacillus pumilus prevents spore germination by formation of a physical barrier and subsequently colonizes fungal spores. QST 2808 Technical is used to formulate Sonata^TM ASO. Sonata^TM ASO is applied at a rate of 0.5 to 2 gallons per acre, except for the treatment of sudden oak death syndrome where the rate range is 1 to 5 gallons per acre.

2. Magnitude of residue at the time of harvest and method used to determine the residue. AgraQuest, Inc. is submitting a petition requesting that EPA establish an exemption from the requirement of a tolerance for the QST strain of Bacillus pumilus, therefore, this section is not applicable.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. AgraQuest, Inc. is submitting a petition requesting that EPA establish an exemption from the requirement of a tolerance for the QST strain of Bacillus pumilus, therefore, an analytical method for residues is not applicable.

C. Mammalian Toxicological Profile

The active ingredient Bacillus pumilus strain QST 2808 has been evaluated for toxicity through oral, dermal, pulmonary, intravenous and eye routes of exposure. The results of the studies have indicated there are no significant human health risks. The acute oral toxicity/pathogenicity LD₅₀ in rats was greater than 4.1 x 10⁹ colony forming units/grams (cfu/g). The acute dermal lethal dose (LD)₅₀ in rats was greater than 2,000 milligrams/kilogram (mg/kg) (Toxicity Category III). The acute pulmonary toxicity/pathogenicity LD₅₀ in rats was greater than 1.6 x 10⁸ cfu per animal. The acute intravenous toxicity/pathogenicity LD₅₀ in rats was greater than 1.6 x 10⁸ cfu per animal. No pathogenic or infective effects were observed in the studies.

Slight eye irritation in rabbits was observed at a dose of 0.1 milliliter (mL) (Toxicity Category IV) and minimal skin irritation in rabbits was observed at a dose of 0.5 mL (Toxicity Category IV). The dermal sensitization study with QST 2808 Technical in Guinea pigs showed that it is not a sensitizer. Since its discovery, no incidents of hypersensitivity have been reported by researchers, manufacturers or users of Bacillus pumilus strain QST 2808.

Acute toxicology studies for the end-use product, Sonata^TM AS, showed a toxicity profile similar to that of the technical material. The acute oral toxicity LD₅₀ in rats was greater than 5,000 mg/kg (Toxicity Category IV). The acute dermal toxicity LD₅₀ in rats was greater than 5,000 mg/kg (Toxicity Category IV). The acute inhalation toxicity LD₅₀ in rats was greater than 1.06 milligrams/per liter (mg/L) (Toxicity Category III). In the acute eye irritation study with rabbits, Sonata^TM AS was classified as a nonirritant by both the EPA and EU classification systems (Toxicity Category IV) at a dose of 0.1 mL. In the acute dermal irritation study with rabbits, Sonata^TM AS was classified as a mild or slight irritant by the EPA classification system (Toxicity Category IV) and as a nonirritant by the EU classification system at a dose of 0.5 mL. The dermal sensitization study in Guinea pigs showed that it is not a sensitizer. No incidents of hypersensitivity have been reported by researchers, manufacturers, or users of Sonata^TM AS or Sonata ASO. The intentionally added inert ingredients together comprise less than 3% of the Sonata^TM AS or Sonata ASO formulations. Their individual amounts range from 0.1% to 0.9%. Obviously, any specific toxicological property of any or all of these inert ingredients had no effect upon the overall toxicity of Sonata^TM AS compared with that of the QST 2808 Technical. Sonata ASO is simply an all-organic formulation version of Sonata^TM AS. The inert ingredients in Sonata ASO are all from EPA's list 4 and thus are considered even more benign than those in Sonata AS. Therefore, the registration data requirements for Sonata ASO will be fulfilled by bridging to the toxicity study results for Sonata^TM AS, per the Data Matrix submitted with the registration application for Sonata ASO. Copies of the Material Safety Data Sheets for the added inert ingredients for Sonata^TM AS were provided in MRID No. 45257201, and for Sonata ASO in MRID No. 46029501.

D. Aggregate Exposure

Sonata ASO is proposed for use to control various plant diseases on agricultural crops.

1. Dietary exposure. Dietary exposure is not expected from the use of this microbial pesticide as proposed. The lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the organism support the exemption from the requirement of a tolerance for this active ingredient.

i. Food. Dietary exposure from use of Bacillus pumilus strain QST 2808, as proposed, is minimal. Residues of Bacillus pumilus strain QST 2808 are not expected on agricultural commodities. In a study conducted to determine the longevity of Bacillus pumilus residues on pepper leaf surfaces under field conditions, the results showed that the number of colony forming units of Bacillus pumilus decreased significantly over time in the first 5 days. In addition, the microbial pesticide can be removed from food by peeling, washing, cooking, and processing.

ii. Drinking water. Exposure to humans from residues of Bacillus pumilus strain QST 2808 in consumed drinking water would be unlikely. Bacillus pumilus strain QST 2808 is a naturally occurring microorganism known to exist in terrestrial habitats. Although, it may be found in water, it is not known to thrive in aquatic environments.

2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are agricultural settings. In addition, non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern. Personal protective equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.

E. Cumulative Exposure

There is no indication of mammalian toxicity of Bacillus pumilus and no information to indicate that toxic effects would be cumulative. Therefore, consideration of a common mode of action is not appropriate. In addition, it is not expected that, when used as proposed, Sonata ASO would result in residues that would remain in human food items.

F. Safety Determination

1. U.S. population. Bacillus pumilus strain QST 2808 is not pathogenic or infective to mammals. There have been no reports of toxins associated with the organism, and acute toxicity/pathogenicity studies have shown that Bacillus pumilus strain QST 2808 is non-toxic, non-pathogenic, and non-irritating. Residues of Bacillus pumilus strain QST 2808 are not expected on agricultural commodities, and therefore, exposure to the general U.S. population, from the proposed uses, is not anticipated.

2. Infants and children. As mentioned above, residues of Bacillus pumilus strain QST 2808 are not expected on agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure to Bacillus pumilus strain QST 2808 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

Bacillus pumilus strain QST 2808 is a naturally occurring, non-pathogenic microorganism. There is no evidence to suggest that Bacillus pumilus strain QST 2808 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

On June 18, 2003, EPA granted a temporary exemption from the requirement of a tolerance for Bacillus pumilus strain QST 2808 in or on all agricultural commodities in conjunction with the issuance of an Experimental Use Permit for Sonata^TM AS (EPA Reg. No. 69592-EUP-1). This exemption will expire June 30, 2006.

I. International Tolerances

There is no Codex alimentarius commission maximum residue level for Bacillus pumilus strain QST 2808.