[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Pages 3693-3696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1550]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-911; FRL-6485-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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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-911, must be 
received on or before February 23, 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-911 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Judy Loranger, Biopesticides 
and Pollution Prevention Division (7511C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 308-8056; 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-911. 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

[[Page 3694]]

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 (CM 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-911 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, 401 M St., SW., 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, CM 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-911. 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 Comestic 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 supports 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 10, 2000.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

Summaries of Petitions

    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 
petitions. These summaries were prepared by Bird Shield Repellent 
Corporation and EPA has not fully evaluated the merits of the pesticide 
petition. The summaries may have been edited by EPA if the terminology 
used was unclear, the summaries contained extraneous material, or the 
summaries unintentionally made the reader conclude that the findings 
reflected EPA's position and not the position of the petitioner.

I. Bird Shield Repellent Corporation

9F5055

    EPA has received a pesticide petition 9F5055 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 in or on sunflower.

A. Product Name and Proposed Use Practices

    The commercial name for the end use product containing methyl 
anthranilate (MA) is Bird Shield Repellent, EPA Reg. No. 66550-1. The 
product was approved for use as a bird repellent on cherries, 
blueberries and grapes on October 3, 1995. 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 180.1143 became effective on April 26, 1995, as published 
in the Federal Register (60 FR 20432) (FRL-4941-8).
    The mode of action is physical whereby the repellent irritates the 
bird's taste buds, olfactory sensors and skin. For this petition, 
methyl anthranilate is

[[Page 3695]]

sprayed in a water solution at a rate of 0.2862 pounds (lbs) per acre 
to sunflowers twice at 7-day intervals until harvest. 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 and other essential 
oils. It is synthetically obtained by esterifying anthranilic acid with 
methanol in the presence of hydrochloric acid. 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 and 
cosmetics, and a flavoring agent in confectionary 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 chromatography and 
mass spectrometry, show no residues at the time of harvest. No residues 
of methyl anthranilate are expected to occur at the time of harvest 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. The lethal dose50 (LD50) values for 
methyl anthranilate were estimated to be greater than 5,000 milligrams/
kilograms (mg/kg) in an acute oral toxicity study in rats (Toxicity 
category IV) and greater than 2,000 mg/kg in an acute dermal toxicity 
study in rats (Toxicity category III). The LC50 value in an 
acute inhalation study in rats was determined to be greater 2.24 mg/
liters (L) (Toxicity category IV). Methyl anthranilate was found to 
cause moderate irritation in a rabbit skin irritation assay and corneal 
effects that cleared in 8 to 21 days in a rabbit eye irritation assay.
    2. Avian. Methyl anthranilate exhibits little or no avian toxicity. 
Methyl anthranilate's irritating properties to avian species preclude 
ingestion. In an acute oral avian toxicity study, methyl anthranilate 
was found to be practically non-toxic to bobwhite quail. In a dietary 
study, methyl anthranilate was determined to be practically non-toxic 
to mallard ducks. Based on these studies, Bird Shield Repellent 
Corporation concludes that methyl anthranilate poses no unique or 
additional risk to avian species.

D. Aggregate Exposure

    1. Dietary exposure --i. Food. The active ingredient in Bird Shield 
Repellent Concentrate, methyl anthranilate, is applied at a rate of 
0.2862 lbs 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 it's volatility, and 
degradation when exposed to ultraviolet light and elevated 
temperatures, no residues are expected at harvest. Dietary exposure to 
methyl anthranilate, via consumption of the treated food or feed, is 
expected to be low to negligible.
    ii. Drinking water. The active ingredient is unlikely to be found 
in drinking water given the very low application rate and rapid 
degradation in soil.
    2. Non-dietary exposure. 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.

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 reasonable certainty of no harm to infants, children 
or adults from aggregate exposure to the chemical's residues. Exempting 
methyl anthranilate from the requirement of a tolerance should pose no 
significant risk to human health or the 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 180.1143 became effective in the Federal Register of April 
26, 1995 (60 FR 20432).

I. International Tolerances

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

II. Bird Shield Repellent Corporation

9F5056

    EPA has received a pesticide petition 9F5056 from Bird Shield 
Repellent Corporation, P.O. Box 785, Pullman, WA 99163, 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 the biochemical pesticide methyl anthranilate in or on 
corn.

A. Product Name and Proposed Use Practices

    The commercial name for the end use product containing methyl 
anthranilate is Bird Shield Repellent, EPA Reg. No. 66550-1. The 
product was approved for use as a bird repellent on cherries, 
blueberries and grapes on October 3, 1995. The active ingredient, 
methyl anthranilate, is a natural constituent of concord and heavy red 
grapes. It is listed by the FDA as a flavoring compound under 21 CFR 
182.60 and is classified as a GRAS compound by the Expert panel of FEMA 
No. 2682. An

[[Page 3696]]

exemption from the requirement of a tolerance for the active 
ingredient, methyl anthranilate for cherries, blueberries and grapes 
under 40 CFR 180.1143 became effective on April 26, 1995 as published 
in the Federal Register (60 FR 20432) (FRL-4941-8).
    The mode of action is physical whereby the repellent irritates the 
bird's taste buds, olfactory sensors and skin. For this petition, 
methyl anthranilate is sprayed in a water solution at a rate of 0.2862 
pounds (lbs.) per acre to corn twice and may be reapplied at 5 to 10 
day intervals until harvest. 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 and other essential 
oils. It is synthetically obtained by esterifying anthranilic acid with 
methanol in the presence of hydrochloric acid. 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 and 
cosmetics, and a flavoring agent in confectionary 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. No residues 
of methyl anthranilate are expected to occur at the time of harvest 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. The LD50 values for methyl anthranilate were 
estimated to be greater than 5,000 mg/kg in an acute oral toxicity 
study in rats (Toxicity category IV) and greater than 2,000 mg/kg in an 
acute dermal toxicity study in rats (Toxicity category III). The 
LC50 value in an acute inhalation study in rats was 
determined to be greater 2.24 mg/L (Toxicity category IV). Methyl 
anthranilate was found to cause moderate irritation in a rabbit skin 
irritation assay and corneal effects that cleared in 8 to 21 days in a 
rabbit eye irritation assay.
    2. Avian. Methyl anthranilate exhibits little or no avian toxicity. 
Methyl anthranilate's irritating properties to avian species preclude 
ingestion. In an acute oral avian toxicity study, methyl anthranilate 
was found to be practically non-toxic to bobwhite quail. In a dietary 
study, methyl anthranilate was determined to be practically non-toxic 
to mallard ducks. Based on these studies, Bird Shield Repellent 
Corporation concludes that methyl anthranilate poses no unique or 
additional risk to avian species.

D. Aggregate Exposure

    1. Dietary exposure --i. Food. The active ingredient in Bird Shield 
Repellent Concentrate, methyl anthranilate, is applied at a rate of 
0.2862 lbs 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, and 
degradation when exposed to ultraviolet light and elevated 
temperatures, no residues are expected at harvest. Dietary exposure to 
methyl anthranilate, via consumption of the treated food or feed, is 
expected to be low to negligible.
    ii. Drinking water. The active ingredient is unlikely to be found 
in drinking water given the very low application rate and rapid 
degradation in soil.
    2. Non-dietary exposure. 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.

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 reasonable certainty of no harm to infants, children 
or adults from aggregate exposure to the chemical's residues. Exempting 
methyl anthranilate from the requirement of a tolerance should pose no 
significant risk to human health or the 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 180.1143 became effective on April 26, 1995 (60 FR 20432).

I. International Tolerances

    Bird Shield Repellent Corporation is not aware of any tolerance, 
exemption from tolerance or MRL's issued for methyl anthranilate 
outside the United States.
[FR Doc. 00-1550 Filed 1-21-00; 8:45 am]
BILLING CODE 6560-50-F