02-4650. 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 all food commodities.

DATES:

Comments, identified by docket control number PF-1064, must be received on or before March 29, 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-1064 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Jim Downing, Biopesticides and Pollution Prevention Division (7505W), 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-1064. 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-1064 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-1064. 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

February 15, 2002.

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 petitioners. 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 [1F6271] from Bird Shield Repellent Corporation, P.O. Box 785, Pullman, WA 99163, 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 biochemical pesticide methyl anthranilate for all food commodities.

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Bird Shield Repellent Corporation has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Bird Shield Repellent Corporation 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 position and not the position of the petitioner.

Bird Shield Repellent Corporation

1F6271

A. Product Name and Proposed Use Practices

The commercial name for the end product containing methyl anthranilate (MA) is Bird Shield Repellent, EPA Reg. No. 66550-1. The product was approved by EPA as a bird repellent for use on cherries, blueberries and grapes on April 26, 1995. It was further approved by the Agency for use on corn and sunflowers in June 2001. The active ingredient, methyl anthranilate, is a natural constituent of concord and heavy red grapes. It is listed by the U.S. Food and Drug Administration (FDA) as a flavoring compound under 21 CFR 182.60 and is classified as a Generally Recognized as Safe (GRAS) compound by the Expert Panel of the Flavoring and Extract Manufacturer's Association (FEMA No. 2682). An exemption from the requirement of a tolerance for the active ingredient, methyl anthranilate for cherries, blueberries and grapes under 40 CFR part 180 became effective on April 26, 1995 (60 FR 20432) (FRL-4941-8), and for corn and sunflowers on June 8, 2001 (66 FR 30822) (FRL-6780-9).

The mode of action is physical whereby the repellent irritates the bird's taste buds, olfactory sensors and skin. Methyl anthranilate is sprayed in a water solution at a rate of 0.283 lb. (131.66 g.) per acre to agricultural crops approximately 15 and 7 days before harvest to control pest bird depredation. Applications to the crop can be applied up to 2 days before harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Methyl anthranilate is a common component of Concord and other red grapes as well as neroli, ylang-ylang, bergamot, jasmine an other essential oils. It is synthetically obtained by esterifying anthranilic acid with CH₃ OH in the presence of HCL. In its crystalline form, it is slightly soluble in water, and freely soluble in alcohol or ether. Methyl anthranilate is commonly used as a perfume for ointments, cosmetics and a flavoring agent in confectionery products, drugs and beverages. Methyl anthranilate readily volatilizes under ultraviolet (uv) light and elevated temperatures.

2. Magnitude of residue at the time of harvest and method used to determine the residue. Residue studies, using gas chromatograph and mass spectrometry, show no residues at the time of harvest for any of the agricultural crops treated with the repellent chemical. No residues of methyl anthranilate are expected to occur at the time of harvest, because of its volatility under sunlight and elevated temperatures, and thus the purpose for proposing an exemption from the requirement of a tolerance.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. The analytical method for detecting and measuring the levels of the residue is described above.

C. Mammalian Toxicological Profile

Methyl anthranilate is approved by the FDA for food use as an artificial flavoring and fragrance agent. Bird Shield Repellent Corporation has reviewed the acute toxicological studies associated with these approvals, and conducted additional studies for verification. Summaries of these studies are presented below:

1. Mammalian. Methyl anthranilate exhibits little or no mammalian toxicity. Methyl anthranilate metabolizes in the intestine when consumed. No toxicity was observed in acute oral toxicity studies. Values for methyl anthranilate were estimated to be greater than 5,000 milligrams/kilograms (mg/kg) in oral toxicity and 2,000 mg/kg in dermal toxicity studies using rats (Toxicity Category IV). Whole body inhalation studies, for the same species, was determined to be greater than 2.24 mg/L. Primary eye irritation was classified as severe and slightly irritating to the skin with rabbits. Based on these studies, Bird Shield Repellent Corporation has concluded that methyl anthranilate poses no unique or additional risk to children or infants, and has proposed an exemption from the requirement of a tolerance for methyl anthranilate.

2. Avian. Methyl anthranilate exhibits little or no avian toxicity. Its irritating properties to avian species preclude its ingestion. Acute oral toxicity was determined to be beyond the limit dose of 2,000 mg/kg of body weight for Bobwhite quail when administered via gelatin capsules. Acute lethal dietary concentrations, where Mallard ducklings were force-fed methyl anthranilate, was determined to be greater than 5,249 mg/kg of diet. Under current EPA criteria, methyl anthranilate is considered to be “practically non-toxic” to mallard ducklings. Based on these studies, Bird Shield Repellent Corporation has concluded that methyl anthranilate poses no unique or additional risk to avian species, and has proposed an exemption from the requirement of a tolerance for methyl anthranilate.

D. Aggregate Exposure

1. Dietary exposure—i. Food. The active ingredient in Bird Shield, methyl anthranilate, is applied at very low rates of 0.29 lbs. (131.7 g.) per acre. Because of the low use rates no active ingredient residues are detectable using available methods on treated crops, even immediately after application. Because of its volatility, when exposed to uv light and elevated temperatures, no residues are expected at harvest. Dietary exposure to methyl anthranilate, via consumption of the treated food or feed, has been determined to be very negligible if any at all. The product's other ingredients, which represent about 75% of the formulation, consist of food grade substances determined to be GRAS by FDA

ii. Drinking water. The active ingredient in Bird Shield is unlikely to occur in drinking water given the very low application rate of the product to the crop and its rapid degradation in soil.

2. Non-dietary exposure. The Bird Shield Repellent Corporation believes that the potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use is primarily to the external, non-edible portions of the crop. This mode of application would not be expected to pose any quantifiable risks due to lack of residues of toxicological concern. Increased non-dietary exposure of methyl anthranilate is not considered likely, because of the low use rates, and the lack of persistence of the active ingredient in the earth's environment.

E. Cumulative Exposure.

Consideration of a common mode of toxicity is not appropriate given there is no indication of mammalian toxicity of methyl anthranilate, and no information that indicates that the toxic effects would be cumulative with any other compounds. Moreover, methyl anthranilate does not exhibit a toxic mode of action in its target species.

F. Safety Determination

1. U.S. population. Methyl anthranilate's lack of toxicity has been demonstrated by the results of acute toxicity testing in mammals, in which the chemical caused no adverse effects when dosed orally and via inhalation at the limit dose for each study. Thus, the aggregate exposure to methyl anthranilate over a lifetime should pose negligible risks to human health.

2. Infants and children. Based on the lack of toxicity and low exposure there is a reasonable certainty of no harm to infants, children or adults will result from aggregate exposure to the chemical's residues. Exempting methyl anthranilate from the requirement of a tolerance should pose no significant risk to humans or their environment.

G. Effects on the Immune and Endocrine Systems

Bird Shield Repellent Corporation, has no information to suggest that methyl anthranilate will adversely affect the immune or endocrine systems.

H. Existing Tolerances

An exemption from the requirement of a tolerance for the active ingredient, methyl anthranilate for cherries, blueberries and grapes under 40 CFR part 180 became effective on April 26, 1995 (60 FR 20432) and extended to corn and sunflowers on June 8, 2001 (66 FR 30822).

I. International Tolerances

Bird Shield Repellent Corporation is not aware of any tolerances, exemptions from tolerance or maximum residue levels issued for methyl anthranilate outside of the United States.