Environmental Protection Agency (EPA).
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.Start Printed Page 22226
Comments, identified by docket control number OPP-50878, must be received on or before June 4, 2001.
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 OPP-50878 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
By mail: Susanne Cerrelli, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8077; e-mail address: email@example.com.End Further Info End Preamble Start Supplemental 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|
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” 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 OPP-50878. 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 (703) 305-5805.
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 OPP-50878 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 (703) 305-5805.
3. Electronically. You may submit your comments electronically by e-mail to: firstname.lastname@example.org, 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 OPP-50878. 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. Start Printed Page 22227
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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: April 19, 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. EPA is publishing the petition summary verbatim without editing it in any way. The petitioner's 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.
EPA has received a pesticide petition 1G6240 from AgraQuest, Inc., 1530 Drew Avenue, Davis, CA 95616, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish a temporary exemption from the requirement of a tolerance for the microbial pesticide Bacillus pumilus strain QST 2808 in or on all raw agricultural commodities (RAC). Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, AgraQuest, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by AgraQuest, Inc. 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
SonataTM AS is proposed for use as a biofungicide to control various plant diseases such as downy mildew, powdery mildew, Phytophthera, Sclerotinia, Cercospora, and/or rust on the following vegetable crop groups: root and tuber, bulb, leafy except Brassica, Brassica, legume, fruiting, and cucurbit; 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, and field grown roses. 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.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. SonataTM AS 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 SonataTM AS. The product will be applied at a maximum rate of 1.18 x 1013 colony forming units per acre, which is equivalent to a maximum rate of 3 gallons of SonataTM AS per acre.
2. Magnitude of residue at the time of harvest and method used to determine the residue. AgraQuest is submitting a petition requesting that EPA establish a temporary 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 is submitting a petition requesting that EPA establish a temporary exemption from the requirement of a tolerance for the QST strain of Bacillus pumilus, therefore, this section 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 is greater than 4.1 x 109 cfu/g. The acute dermal toxicity LD50 in rats is greater than 2,000 milligrams/kilograms (mg/kg) (toxicity category III). The acute pulmonary toxicity/pathogenicity LD50 in rats is greater than 1.6 x 108 cfu per animal. The acute intravenous toxicity/pathogenicity LD50 in rats is 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 mL (toxicity category IV) and minimal skin irritation in rabbits was observed at a dose of 0.5 mL (toxicity category IV). Since its discovery, no incidents of hypersensitivity have been reported by researchers, manufacturers or users of Bacillus pumilus strain QST 2808. The formulated product is a very dilute aqueous suspension of Bacillus pumilus, with <3%% intentionally added inert ingredients. It is unlikely that this product's toxicity profile will differ from that of the technical material. Acute toxicology studies are in progress on the formulated product.
D. Aggregate Exposure
SonataTM AS is proposed for use under an experimental use permit 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 Start Printed Page 22228microbial 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, SonataTM AS would result in residues that would remain in human food items.
F. Safety Determination
Risk and exposure to humans, infants, and children is likely to be minimal.
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
There is no U.S. EPA tolerance for Bacillus pumilus strain QST 2808.
I. International Tolerances
There is no Codex Alimentarius Commission maximum residue level (MRL) for Bacillus pumilus strain QST 2808.End Supplemental Information
[FR Doc. 01-11094 Filed 5-2-01; 8:45 am]
BILLING CODE 6560-50-S