Notice of Filing of Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals in or on Food

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

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

DATES:

Comments, identified by docket control number PF-955, must be received on or before August 31, 2000.

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-955 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Alan Reynolds, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 605-0515; e-mail address: reynolds.alan@epa.gov.

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:

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-955. 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 PF-955 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: “opp-docket@epa.gov,” 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-955. 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 pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain 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 petitions. Additional data may be needed before EPA rules on the petitions.

List of Subjects

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

Summaries of Petitions

The petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the view of the petitioners. The petition summaries 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.

I. Natural Industries, Inc.

0F6163

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

The active ingredient Streptomyces lydicus WYEC 108 is intended for use as a biological fungicide for the control of soil borne plant root rot and damping-off fungi. Fungi controlled include: Fusarium, Rhizoctonia, Pythium, Phytophthora, Phytomatotricum, Aphanomyces, Monosprascus, Armillaria and other root-decay fungi. The active ingredient colonizes the root system, thus out competing other harmful fungi, and enhances plant vitality.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Streptomyces lydicus WYEC 108 colonizes the growing root tips of plants and acts as a mycoparasite of fungal root pathogens to protect plants. Root colonization is a form of competitive exclusion of a pathogen from the root system. Other mechanisms of action include the production and excretion of anti-fungal metabolites (e.g., antibiotics and/or low molecular weight anti-fungal compounds) into the rhizosphere surrounding the roots of colonized plants, and mycoparasitism of the spores and vegetative mycelium of the fungal pathogens (e.g., via colonization of the spores of hyphae of the fungus, followed by the production of lytic enzymes such as chitinase). No deleterious effects to plants have been observed as a result of excretion of anti-fungal compounds from Streptomyces lydicus WYEC 108.

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. End-use products of Streptomyces lydicus WYEC 108 will be intended for greenhouse, nursery and turf grass use (food and non-food) as a soil mix or a soil drench. The products will be applied only to the soil, not to growing crops directly, and are not intended for use in irrigation systems. Residues of Streptomyces lydicus WYEC 108 are not expected on agricultural commodities.

C. Mammalian Toxicological Profile

The active ingredient Streptomyces lydicus WYEC 108 and the end-use product Actinovate^tm Soluble have been evaluated for toxicity through oral, dermal, pulmonary, and eye routes of exposure. The results of the studies have indicated toxicity category IV, which pose no significant human health risks.

For the active ingredient, the acute pulmonary toxicity/pathogenicity in rats is greater than 9.1 x 10⁸ colony forming units (CFU) per animal and the acute injection toxicity/pathogenicity in rats is greater than 9.33 x 10⁸ cfu per animal. No pathogenic or infective effects were observed in the studies. For the end-use formulation, the acute oral toxicity in rats was greater than 5,050 milligrams per kilograms (mg/kg) (toxicity category IV), eye irritation in rabbits was not observed at a dose of 0.1 milliliters (mL) (toxicity category IV) and skin irritation in rabbits was not 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.

A waiver is being requested for acute dermal toxicity/pathogenicity based on the fact that there was no toxicity or pathogenicity in the pulmonary and injection studies, and no effects were observed in the skin irritation study. Dermal toxicity or pathogenicity would not be expected for this active ingredient. Finally, the organism has never been reported as a pathogen of humans, or as causing any type of adverse effect to humans, in published literature or through commercial use.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Dietary exposure from use of Streptomyces lydicus WYEC 108, as proposed, is minimal. Streptomyces lydicus WYEC 108 is applied as a soil mix or soil drench. It is not applied to growing crops directly. Residues of Streptomyces lydicus WYEC 108 are not expected on agricultural commodities.

ii. Drinking water. Similarly, exposure to humans from residues of Streptomyces lydicus WYEC 108 in consumed drinking water would be unlikely. Streptomyces lydicus WYEC 108 is a naturally-occurring soil microorganism found in soil types world-wide. While spores of Streptomyces lydicus WYEC 108 may be found in aquatic environments, possibly because they are washed-in from surrounding terrestrial habitats, they are 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 and horticultural 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 mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural and horticultural settings.

E. Cumulative Exposure

It is not expected that, when used as proposed, Streptomyces lydicus WYEC 108 would result in residues that would remain in human food items.

F. Safety Determination

1. U.S. population. Streptomyces lydicus WYEC 108 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 Streptomyces lydicus WYEC 108 is non-toxic, non-pathogenic, and non-irritating. Streptomyces lydicus WYEC 108 is applied to the soil. It is not applied to growing crops directly. Residues of Streptomyces lydicus WYEC 108 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 Streptomyces lydicus WYEC 108 are not expected on agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure to Streptomyces lydicus WYEC 108 from the proposed uses.

G. Effects on the Immune and Endocrine Systems

Streptomyces lydicus WYEC 108 is a naturally-occurring, non-pathogenic soil organism. To date there is no evidence to suggest that Streptomyces lydicus WYEC 108 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 established for Streptomyces lydicus WYEC 108.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level is not required for Streptomyces lydicus WYEC 108.

II. Encore Technologies LLC

0F6170

EPA has received a pesticide petition 0F6170 from Encore Technologies LLC, 111 Cheshire Lane, Minnetonka, MN 55305, 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 microbial pesticide Colletotrichum gloeosporioides f. sp. malvae.

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

Colletotrichum gloeosporioides f. sp. malvae is a naturally occurring fungus that is pathogenic to the weeds round-leaved mallow (Malva pusila), small flowered mallow (Malva parviflora), common mallow (Malva neglecta), and velvet leaf (Abutilon theophrasti), all of which are members of the family Malvaceae. The organism will infect and kill round-leaved and small flowered mallows at any stage of growth, from seedling to mature plant. Colletotrichum gloeosporioides f. sp. malvae causes disease lesions that will completely encircle the stems and petioles of mallow, causing the plant to collapse in 2 to 4 weeks.

The end-use formulation, Mallet WP, is a two-component product. Mallet WP Component A consists of a 16-oz. bottle containing a water soluble spore nutrient and rehydrating agent that activates the spores prior to application. Mallet WP Component M consists of a bag containing a water suspendible dried fungal spore formulation of Colletotrichum gloeosporioides f. sp. malvae. The product is applied to field crops at an early stage to control target weeds.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Colletotrichum gloeosporioides f. sp. malvae was originally isolated and characterized by Dr. Knud Mortensen, Agriculture Canada Research Scientist, Regina, Saskatchewan in 1982. Colletotrichum gloeosporioides f. sp. malvae has been reported as indigenous to the provinces of Saskatchewan and Manitoba, occurring as an endemic pathogen of round-leaved mallow producing lesions on aerial parts. The active ingredient is registered in Canada as BioMal® for control of round-leaved mallow in field crops. Extensive efficacy and field research trials were conducted in Canada, with results showing that the organism provided consistent and effective control over a wide variety of environmental conditions. Since it's discovery in 1982, there have been no reports of adverse effects, sensitivity or reaction of any type related to use or handling of this organism.

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 Colletotrichum gloeosporioides f. sp. malvae calls for application to field crops at an early stage for control of mallow 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 Colletotrichum gloeosporioides f. sp. malvae in food crops. Furthermore, the host weed species are not palatable forage for cattle or other livestock populations, either through direct feeding upon diseased plants, or indirectly through feeding upon crops that have been treated with Colletotrichum gloeosporioides f. sp. malvae. Residues of Colletotrichum gloeosporioides f. sp. malvae are not expected on agricultural commodities.

C. Mammalian Toxicological Profile

The active ingredient Colletotrichum gloeosporioides f. sp. malvae 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, the acute oral toxicity/pathogenicity in rats is greater than 6 x 10⁵ cfu/(g) grams, the acute dermal toxicity/pathogenicity in rats is greater than 4.21 x 10⁷ cfu/g, the acute pulmonary toxicity/pathogenicity in rats is greater than 4.55 x 10⁴ cfu per animal, and the acute intraperitoneal toxicity/pathogenicity in rats is greater than 5.7 x 10⁵ cfu per animal. No pathogenic or infective effects were observed in the studies. Data on the end-use formulation is cited from the substantially similar product Collego (Colletotrichum gloeosporioides f. sp. aeschynomene, EPA Reg. No. 70571-1). For the end-use formulation, slight eye irritation in rabbits was observed at a dose of 0.1 mL (toxicity category IV) and skin irritation in rabbits was not 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 Colletotrichum gloeosporioides f. sp. malvae, as proposed, is minimal. The use of Colletotrichum gloeosporioides f. sp. malvae calls for application to field crops at an early stage for control of mallow 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 Colletotrichum gloeosporioides f. sp. malvae in food crops. Residues of Colletotrichum gloeosporioides f. sp. malvae are not expected on agricultural commodities.

ii. Drinking water. Similarly, exposure to humans from residues of Colletotrichum gloeosporioides f. sp. malvae in consumed drinking water would be unlikely. Colletotrichum gloeosporioides f. sp. malvae 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 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, Colletotrichum gloeosporioides f.sp. malvae would result in residues that would remain in human food items.

F. Safety Determination

1. U.S. population. Colletotrichum gloeosporioides f. sp. malvae 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 Colletotrichum gloeosporioides f. sp. malvae is non-toxic, non-pathogenic, and non-irritating. Residues of Colletotrichum gloeosporioides f. sp. malvae 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 Colletotrichum gloeosporioides f. sp. malvae are not expected on agricultural commodities. There is a reasonable certainty of no harm for infants and children from exposure to Colletotrichum gloeosporioides f. sp. malvae from the proposed uses.

G. Effects on the Immune and Endocrine Systems

Colletotrichum gloeosporioides f. sp. malvae is a naturally-occurring, non-pathogenic microorganism. To date there is no evidence to suggest that Colletotrichum gloeosporioides f. sp. malvae 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 Colletotrichum gloeosporioides f. sp. malvae.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level is not required for Colletotrichum gloeosporioides f. sp. malvae.