01-1353. 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-986, must be received on or before February 16, 2001.

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-961 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Sharlene Matten, 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” 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-986. 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-986 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-986. 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 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: January 5, 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. 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.

EPA has received a pesticide petition PP 0F6191 from Platte Chemical Company, j419 18th Street, Greeley, CO 80632-0667, proposing pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (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 Alternaria destruens.

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

Platte Chemical Company

PP 0F6191

A. Product Name and Proposed Use Practices

Alternaria destruens is a naturally occurring fungus that is pathogenic to Cuscuta spp., often referred to as dodder, swamp dodder, largeseed dodder, field dodder or small seed dodder. The active ingredient will infect and suppress dodder at early stages of growth. Dodder is a leafless, rootless weed that is parasitic on cranberries and other crops, directly reducing vigor. Dodder generally germinates in late spring, twining stems around the host to derive its nutrients from that plant.

Two formulations of Alternaria destruens are proposed, one for the control of emerging dodder and one for the control of dodder that has attached to and infested the host plant. Smolder L G, a granular product, is proposed for use on known sites of dodder infestation, as it emerges in the spring, to suppress dodder growth and seed production. Smolder L WP, a sprayable product, is proposed for use on growing dodder, as spot or area treatment to control further growth. Use sites include vegetables, fruits, field crops and non-agricultural areas such as uncultivated rights-of-way, roadsides and fallow areas.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Alternaria destruens is a naturally occurring fungus that is pathogenic to Cuscuta spp., often referred to as dodder, swamp dodder, largeseed dodder, field dodder or small seed dodder. The active ingredient will infect and suppress dodder at early stages of growth. Alternaria destruens requires adequate moisture and temperature during the infection period (3 to 4 hours). In very dry or drought conditions, when dew is absent, the onset of the infection process might be delayed until moisture conditions return. Alternaria destruens has been shown to survive in nature only on live or dead tissue of the host weed species. Survival on soil or non-susceptible plant tissue would be limited.

2. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. An analytical method for residues is not applicable. The use of Alternaria destruens calls for application to field crops at an early stage for control of dodder species. Consequently, there is a considerable time lag between application and harvesting of crops. Since survival of the organism is in part dependent on existence of the host plant, it is unlikely that application will result in the presence of Alternaria destruens in food crops. Residues of Alternaria destruens are not expected on agricultural commodities.

C. Mammalian Toxicological Profile

The active ingredient Alternaria destruens has been evaluated for toxicity through oral, dermal, pulmonary, intraperitoneal, and eye routes of exposure. The results of the studies have indicated there are no significant human health risks.

For the active ingredient, acute oral toxicity/pathogenicity in rats is greater than 1 X 10⁷ cfu/animal, acute pulmonary toxicity/pathogenicity in rats is greater than 5 X 10⁵ cfu/animal, and acute intraperitoneal toxicity/pathogenicity in rats is greater than 9.6 X 10⁶ cfu/animal. No pathogenic or infective effects were observed in the studies. For the end-use wettable powder formulation, acute dermal toxicity in rats is greater than 5,000 mg/kg (Toxicity Category IV), acute inhalation toxicity in rats is greater than 2.03 mg/l (Toxicity Category IV), minimal eye irritation in rabbits was observed at a dose of 0.1 ml (Toxicity Category III) and no 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.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary exposure from use of Alternaria destruens, as proposed, is minimal. The use of Alternaria destruens calls for application to field crops at an early stages for control of dodder species. Consequently, there is a considerable time lag between application and harvesting of crops. Since survival of the organism is in part dependent on existence of the host plant, it is unlikely that application will result in the presence of Alternaria destruens in food crops. Residues of Alternaria destruens are not expected on agricultural commodities.

ii. Drinking water. Similarly, exposure to humans from residues of Alternaria destruens in consumed drinking water would be unlikely. Alternaria destruens is a naturally-occurring microorganism known to exist in terrestrial habitats in the presence of a host plant, it is not known to grow or 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. However, non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

Person Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.

E. Cumulative Exposure

It is not expected that, when used as proposed, Alternaria destruens would result in residues that would remain in human food items.

F. Safety Determination

1. U.S. population. Alternaria destruens is not pathogenic or infective to mammals. There have been no reports of toxins or secondary metabolites associated with the organism, and acute toxicity studies have shown that Alternaria destruens is non-toxic, non-pathogenic, and non-irritating. Residues of Alternaria destruens 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 Alternaria destruens are not expected on agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure to Alternaria destruens from the proposed uses.

G. Effects on the Immune and Endocrine Systems

Alternaria destruens is a naturally-occurring microorganism. To date there is no evidence to suggest that Alternaria destruens 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 Alternaria destruens.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not required for Alternaria destruens.