01-31249. 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-1037, must be received on or before January 18, 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-1037 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-1037. 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-1037 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-1037. 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
• Biopesticides
• Feed additives
• Food additives
• Pesticides and pests
• Pollution prevention
• Reporting and recordkeeping requirements

Dated: December 11, 2001.

Kathleen F. Knox,

Acting 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. 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.

Growth Products Ltd.

PP 1G6307

EPA has received a pesticide petition [1G6307] from Growth Products Ltd. , PO Box 1259, White Plains, NY 10602, 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 temporary tolerance for the microbial pesticide Bacillus subtilis GB03.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Growth Products Ltd. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Growth Products Ltd. 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

Companion Liquid Biological Fungicide 00.03% Bacillus subtilis GB03 is to be used on ≤200 acres in five states to obtain efficacy and phytotoxicity data, evaluate application rates and evaluate timing to establish disease control over a large geographical area on many important specialty crops. Disease severity and intensity will be observed, as well as measurements of root growth in both length and mass, leaf color, and tissue analysis of nutrient levels, all of which are indicators of healthy plants. Food crops to be treated include apples, broccoli, celery, citrus, cotton, grapes (raisin, table and wine), lettuce (iceberg and leaf), melons, onions, potatoes, herbs and spices, strawberries, sunflower, tobacco and tomatoes. The proposed time period for the permit is 2 years.

B. Product Identity/Chemistry

1. Identity of the pesticide. The active ingredient is Bacillus subtilis GB03 which is the biological pesticide Kodiak^TM Concentrate Biological Fungicide which has the EPA Reg. No. 7501-144 maintained by the company Gustafson LLC for use as a seed treatment of agricultural commodities. The company has established a tolerance exemption specific to that use (40 CFR 180.1111). In storage the product is stable for at least 1 year when stored in original packaging according to label directions. The mode of action of Bacillus subtilis GB03 results from its colonization of the developing root system of plants, thereby suppressing and controlling root diseases by competition. The organism has been shown to increase root mass and plant health on various agricultural commodities.

2. Analytical method. An analytical method for residues is not applicable. Residues of Bacillus subtilis GB03 are not expected on agricultural commodities.

C. Mammalian Toxicological Profile

Toxicological data on the active ingredient had been previously accepted to support the current exemption from the requirement of a tolerance for residues for seed treatment of agricultural commodities See 40 CFR 180.1111). These studies include an acute oral toxicity/pathogenicity study in the rat, an acute dermal toxicity study in the rabbit, an acute pulmonary toxicity/pathogenicity study in the rat, an acute intravenous toxicity/pathogenicity study in the rat and a primary eye irritation study in the rabbit. EPA found from a review of these studies that the active ingredient was not toxic to test animals when administered via the oral, dermal, intravenous, or pulmonary routes of exposure. The active ingredient was not infective or pathogenic to test animals when administered via the oral, pulmonary, and intravenous routes. No reports of hypersensitivity had been reported from personnel working with this organism.

Toxicological data on the end-use product Companion Liquid Biological Fungicide had been previously accepted to support a registration for non-food greenhouse use. An acute oral toxicity study showed no toxicity at a dose of 5,000 milligrams/kilograms (mg/kg) in rats (Toxicity category IV), a primary eye irritation study showed mild irritation at a dose of 0.1 milliliters (mL) in rabbits (Toxicity Category IV), and a primary dermal irritation study showed moderate dermal irritation at a dose of 0.5 mL in rabbits (Toxicity Category III). The results of the above studies indicate that there are no significant human health risks associated with the active ingredient or end use product.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary exposure from use of Bacillus subtilis GB03 is expected to be minimal. Its use involves low levels of the active ingredient applied to growing plants prior to harvest. Residues if Bacillus subtilis GB03 are not expected to be on agricultural commodities. However should any residues occur they would not be of any toxicological concern.

ii. Drinking water. Exposure to humans from residues of Bacillus subtilis GB03 in consumed drinking water would be unlikely. Bacillus subtilis GB03 is a naturally occurring soil micro-organism and it is not known to thrive in aquatic environments. Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure.

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. However, 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 possibility of exposure for applicators and handlers of the proposed products, when used in agricultural settings.

E. Cumulative Exposure

It is not expected that, when used as proposed, products containing Bacillus subtilis GB03 would result in residues that would remain in human food items. The organism is not pathogenic or infective to mammals. There have been no reports of toxins or secondary metabolites associated with this organism, and acute toxicity studies have shown that Bacillus subtilis GB03 is non-toxic and non-pathogenic.

F. Safety Determination

1. U.S. population. Acute toxicity studies have shown that Bacillus subtilis GB03 is not toxic. Residues of this organism are not expected to be on agricultural commodities; however, should residues occur they would not be of toxicological concern. There is a reasonable certainty of no harm to the general U.S. population from exposure to this active ingredient.

2. Infants and children. As mentioned above, residues of Bacillus subtilis GB03 are not expected to be on agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure to Bacillus subtilis GB03 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Bacillus subtilis GB03 functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

There is an existing EPA tolerance in 40 CFR 180.1111: Bacillus subtilis GB03; exemption from the requirement of a tolerance. The biofungicide Bacillus subtilis GB03 is exempted from the requirement of a tolerance in or on all raw agricultural commodities when applied as a seed treatment for growing agricultural crops in accordance with good agricultural practices (established June 30, 1992).

I. International Tolerances

A codex Alimentarium Commission Maximum Residue Level (MRL) is not required for Bacillus subtilis GB03.