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Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 24, 2000 (Volume 65, Number 15)]
[Notices]
[Page 3693-3696]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja00-54]
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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:
loranger.judy@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:
------------------------------------------------------------------------
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: ``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-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