01-32109. 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 control number PF-1062, must be received on or before January 30, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1062 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Anne Ball, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

Categories	NAICS codes	Examples of potentially affected entities
Industry	111	Crop production
	112	Animal production
	311	Food manufacturing
	32532	Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an official record for this action under docket control number PF-1062. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PF-1062 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number PF-1062. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified 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 control 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 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

Dated: December 14, 2001.

Janet L. Andersen,

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

Summary of Petition

The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. EPA is publishing the petition summary verbatim without editing it in any way. 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.

Gustafson LLC

PP 1F6344

EPA has received a pesticide petition (PP 1F6344) from Gustafson LLC, 1400 Preston Road, Suite 400, Plano, TX 75093, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the microbial pesticide Bacillus pumilus GB34 when used as a seed treatment in or on all raw agricultural commodities and on all food commodities after harvest.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Gustafson LLC has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Gustafson LLC and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

The active ingredient Bacillus pumilus GB34 is formulated into the technical product, GB34 Technical Biological Fungicide and the end use product GB34 Concentrate Biological Fungicide. GB34 concentrate contains bacteria which colonize the developing root system of soybeans suppressing disease organisms such as Rhizoctonia and Fusarium that attack root systems. GB34 concentrate is used as a seed treatment before planting.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Bacillus pumilus GB34 is a naturally occurring isolate from the soil.

2. Magnitude of residue at the time of harvest and method used to determine the residue. Two processing studies with soybeans were conducted. The studies showed no uptake of Bacillus pumilus GB34 beyond the seed hull. No residues were found in meal, oil, soymilk, or tofu.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. An analytical method for enumeration of microorganisms is available but is not required since the petitioner is requesting an exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

Bacillus pumilus GB34 was not found to be toxic or pathogenic from acute intravenous administration of 1.1 x 10⁷ cfu of technical grade material. The oral LD₅₀ of GB34 technical was greater than 5,000 milligrams/kilograms (mg/kg) of body weight. GB34 technical was classified non-irritating to the skin and mildly irritating to the eye in primary skin irritation and eye irritation studies. The oral LD₅₀ of GB34 concentrate was greater than 5,000 mg/kg of body weight. GB34 concentrate was classified as non-irritating to the skin and minimally irritating to the eye in primary skin irritation and eye irritation studies. An avian oral pathogenicity and toxicity study in northern Bobwhite showed no evidence of pathogenicity during gross necropsy. The no observed adverse effect level (NOAEL) was approximately 3.4 x 10¹¹ cfu/kg/day for 5 days.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Bacillus pumilus GB34 does not exhibit any mammalian toxicity. Therefore, any dietary exposure would not be harmful to humans. Also Bacillus pumilus GB34 is a naturally occurring, ubiquitous microorganism indigenous to the United States.

ii. Drinking water. Bacillus pumilus is found in the soil and the use rate of GB34 concentrate is 0.1 ounces per 100 pounds of seed, equivalent to 1.7 grams per acre. Bacillus pumilus GB34 is unlikely to leach from the treated seed and would not be distinguishable from other naturally occurring Bacillus pumilus.

2. Non-dietary exposure. As a commercial seed treatment for soybeans, the general population, including infants and children, will have a very low possibility of exposure. Occupational exposure will be limited to employees in commercial facilities handling the seed treatment product. Commercial seed treating equipment minimizes occupational exposure. Wearing protective equipment will also minimize occupational exposure. Non-dietary exposure would not be expected to pose a quantifiable risk.

E. Cumulative Exposure

The product strain belongs to the bacterial genus of Bacillus. Bacillus pumilus GB34 may have a similar mode of action in mammals as Bacillus subtilis that has been shown to be non-toxic and non-pathogenic in mammalian species. A similar mode of action of Bacillus pumilus GB34 and Bacillus subtilis would not be expected to result in an increased adverse effect since both were shown to be non-toxic and non-pathogenic in intravenous toxicity and pathogenicity studies.

F. Safety Determination

1. U.S. population. Based on the low treating rate of seed treatment use, little evidence of toxicity or pathogenicity and limited exposure potential, Gustafson LLC believes there is a reasonable certainty of no harm to the U.S. population in general from aggregate exposure to Bacillus pumilus GB34 residue from all anticipated dietary and non-dietary exposures.

2. Infants and children. Based on the lack of toxicity and low exposure there is a reasonable certainty that no harm to infants, children or adults will result from aggregate exposure to Bacillus pumilus GB34.

G. Effects on the Immune and Endocrine Systems

Gustafson LLC has no information to suggest that Bacillus pumilus GB34 will have any effect on the immune and endocrine systems.

H. Existing Tolerances

There are no existing tolerances for Bacillus pumilus GB34.

I. International Tolerances

Gustafson LLC is not aware of any international tolerances, exemptions from tolerance or maximum residue levels for Bacillus pumilus GB34.