[Federal Register Volume 67, Number 39 (Wednesday, February 27, 2002)]
[Notices]
[Pages 8968-8971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4650]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1064; FRL-6818-9]


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.

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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: (703) 308-9071; e-mail address: 
[email protected].

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:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         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

[[Page 8969]]

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-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 (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], 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

[[Page 8970]]

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 
CH3OH 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

[[Page 8971]]

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.
[FR Doc. 02-4650 Filed 2-26-02; 8:45 am]
BILLING CODE 6560-50-S