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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 22, 2001 (Volume 66, Number 163)]
[Notices]
[Page 44136-44140]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au01-68]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[PF-1035; FRL-6794-6]

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 various food commodities.

DATES: Comments, identified by docket control number PF-1035, must be
received on or before September 21, 2001.

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-1035 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Fungicide Branch, Registration Division (7505C),

[[Page 44137]]

Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703)
305-7740; e-mail address: giles-parker.cynthia@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-1035. 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-1035 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-1035. 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

[[Page 44138]]

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.

Dated: August 8, 2001.
James Jones,
Director, Registration 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
petitioner. EPA is publishing the petition summary verbatim without
editing it in any way. 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.

Syngenta Crop Protection, Inc.

0F6218

EPA has received a pesticide petition (0F6218) from Syngenta Crop
Protection, Inc., 410 Swing Road, P.O. Box 18300, Greensboro, North
Carolina 27409-8300 proposing, pursuant to section 408(d) of the FFDCA,
21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances
for residues of azoxystrobin (methyl(E)-2-2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl-3- methoxyacrylate) and the Z
isomer of azoxystrobin, (methyl(Z)-2-2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl-3-methoxyacrylate) in or on the raw agricultural
commodities legume vegetables (succulent or dried) group at 3 parts per
million (ppm), hops at 50 ppm, grapes at 3 ppm, tomatoes at 2 ppm, and
tomato paste at 6 ppm. The proposed tolerance in or on grapes is an
increase from the current tolerance of 1.0 ppm, the proposed tolerance
in or on tomatoes is an increase from the current tolerance of 0.2 ppm,
and the proposed tolerance in or on tomato paste is an increase from
the current tolerance of 0.6 ppm. The proposed tolerances on legume
vegetables (succulent or dried) group and hops are new. EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; 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.

A. Residue Chemistry

1. Plant metabolism. The metabolism of azoxystrobin as well as the
nature of the residues is adequately understood for purposes of the
tolerances. Plant metabolism has been evaluated in four diverse crops,
cotton, grapes, wheat and peanuts, which should serve to define the
similar metabolism of azoxystrobin in a wide range of crops. Parent
azoxystrobin is the major component found in crops. Azoxystrobin does
not accumulate in crop seeds or fruits. Metabolism of azoxystrobin in
plants is complex with more than 15 metabolites identified. These
metabolites are present at low levels, typically much less than 5% of
the total recoverable residue (TRR).
2. Analytical method. An adequate analytical method, gas
chromatography with nitrogen-phosphorus detection (GC-NPD) or in mobile
phase by high performance liquid chromatography with ultra-violet
detection (HPLC-UV), is available for enforcement purposes with a limit
of detection that allows monitoring of food with residues at or above
the levels set in these tolerances. EPA concluded that the method(s)
are adequate for enforcement. Analytical methods are also available for
analyzing meat, milk, poultry, and eggs, and also underwent successful
independent laboratory validations.
3. Magnitude of residues. Nineteen residue trials in legume
vegetables were carried out in the United States and Canada in 1998 and
1999. Maximum residues of 1.9 ppm resulted from multiple foliar
applications. Six residue trials in hops were carried out in the United
Kingdom and Germany in 1998 and 1999. Maximum residues were 16 ppm. In
the interest of harmonizing United States tolerances with those of
Canada and the European Union, representative residue data from Canada
and Germany are presented that demonstrate maximum residues of 2.4 ppm
in grapes and 1.3 ppm in tomatoes.

B. Toxicological Profile

1. Acute toxicity. The acute oral toxicity study in rats of
technical azoxystrobin resulted in an LD₅₀ of > 5,000
milligrams/kilogram (mg/kg limit test) for both males and females. The
acute dermal toxicity study in rats of technical azoxystrobin resulted
in an LD₅₀ of > 2,000 mg/kg (limit dose). The acute
inhalation study of technical azoxystrobin in rats resulted in an
LC₅₀ of 0.962 milligrams/liter (mg/L) in males and 0.698 mg/
L in females. In an acute oral neurotoxicity study in rats dosed once
by gavage with 0, 200, 600, or 2,000 mg/kg azoxystrobin, the systemic
toxicity no observed adverse effect level (NOAEL) was < 200 mg/kg and
the systemic toxicity NOAEL was 200 mg/kg, based on the occurrence of
transient diarrhea in both sexes. There was no indication of
neurotoxicity at the doses tested.
2. Genotoxicity. Azoxystrobin was negative for mutagenicity in the
salmonella/mammalian activation gene mutation assay, the mouse
micronucleus test, and the unscheduled deoxyribonucleic acid (DNA)
synthesis in rat hepatocytes/mammalian cells in vivo/in vitro procedure
study. In the forward mutation study using L5178 mouse lymphoma cells
in culture, azoxystrobin tested positive for forward gene mutation at
the TK locus. In the in vitro human lymphocytes cytogenetics assay of
azoxystrobin, there was evidence of a concentration-related induction
of chromosomal aberrations over background in the presence of moderate
to severe cytotoxicity.
3. Reproductive and developmental toxicity. In a prenatal
development study in rats gavaged with azoxystrobin at dose levels of
0, 25, 100, or 300 milligrams per kilogram per day (mg/kg/day) during
days 7 through 16 of gestation, lethality at the highest dose caused
the discontinuation of dosing at that level. The developmental NOAEL
was greater than or equal to 100 mg/kg/day and the developmental lowest
observed adverse effect level (LOAEL) was > 100 mg/kg/day because no
significant adverse developmental effects were observed. In this same
study, the maternal NOAEL was not established; the maternal LOAEL was
25 mg/kg/day, based on increased salivation.
In a prenatal developmental study in rabbits gavaged with 0, 50,
150, or 500 mg/kg/day during days 8 through 20 of gestation, the
developmental NOAEL was 500 mg/kg/day and the developmental LOAEL was >
500 mg/kg/day because no treatment-related adverse effects on
development were seen. The maternal NOAEL was 150 mg/kg/day and the
maternal LOAEL was 500 mg/kg/day, based on decreased body weight gain.
In a 2-generation reproduction study, rats were fed 0, 60, 300, or
1,500 ppm of azoxystrobin. The reproductive NOAEL was 32.2 mg/kg/day.
The reproductive LOAEL was 165.4 mg/kg/day; reproductive toxicity was

[[Page 44139]]

demonstrated as treatment-related reductions in adjusted pup body
weights as observed in the F18 and F2 pups dosed at 1,500 ppm (165.4
mg/kg/day).
4. Subchronic toxicity. In a 90-day rat feeding study the NOAEL was
20.4 mg/kg/day for males and females. The LOAEL was 211.0 mg/kg/day
based on decreased weight gain in both sexes, clinical observations of
distended abdomens and reduced body size, and clinical pathology
findings attributable to reduced nutritional status.
In a subchronic toxicity study in which azoxystrobin was
administered to dogs by capsule for 92 or 93 days, the NOAEL for both
males and females was 50 mg/kg/day. The LOAEL was 250 mg/kg/day, based
on treatment-related clinical observations and clinical chemistry
alterations at this dose.
In a 21-day repeated-dose dermal rat study using azoxystrobin, the
NOAEL for both males and females was greater than or equal to 1,000 mg/
kg/day (the highest dosing regimen); a LOAEL was, therefore, not
determined.
5. Chronic toxicity and carcinogenicity. In a 2-year feeding study
in rats fed diets containing 0, 60, 300, and 750/1,500 ppm (males/
females), the systemic toxicity NOAEL was 18.2 mg/kg/day for males and
22.3 mg/kg/day for females. The systemic toxicity LOAEL for males was
34 mg/kg/day, based on reduced body weights, food consumption, and food
efficiency, and bile duct lesions. The systemic toxicity LOAEL for
females was 117.1 mg/kg/day, based on reduced body weights. There was
no evidence of carcinogenic activity in this study.
In a 1-year feeding study in dogs to which azoxystrobin was fed by
capsule at doses of 0, 3, 25, or 200 mg/kg/day, the NOAEL for both
males and females was 25 mg/kg/day and the LOAEL was 200 mg/kg/day for
both sexes, based on clinical observations, clinical chemistry changes,
and liver weight increases that were observed in both sexes.
In a 2-year carcinogenicity feeding study in mice using dosing
concentrations of 0, 50, 300, or 2,000 ppm, the systemic toxicity NOAEL
was 37.5 mg/kg/day for both males and females. The systemic toxicity
LOAEL was 272.4 mg/kg/day for both sexes, based on reduced body weights
in both at this dose. There was no evidence of carcinogenicity at the
dose levels tested.
According to the new proposed guidelines for Carcinogen Risk
Assessment (April 1996), the appropriate descriptor for human
carcinogenic potential of azoxystrobin is ``not likely.'' The
appropriate subdescriptor is ``has been evaluated in at least two well
conducted studies in two appropriate species without demonstrating
carcinogenic effects.''
6. Animal metabolism. In this study azoxystrobin, unlabeled or with
a pyrimidinyl, phenylacrylate, or cyanophenyl label, was administered
to rats by gavage as a single or as 14-day repeated doses. Less than
0.5% of the administered dose was detected in the tissues and carcass
up to 7 days post-dosing and most of it was in excretion-related
organs. There was no evidence of potential for bioaccumulation. The
primary route of excretion was via the feces, though 9 to 18% was
detected in the urine of the various dose groups. Absorbed azoxystrobin
appeared to be extensively metabolized. A metabolic pathway was
proposed showing hydrolysis and subsequent glucuronide conjugation as
the major biotransformation process.
7. Metabolite toxicology. There are no metabolites of concern based
on a differential metabolism between plants and animals.
8. Endocrine disruption. There is no evidence that azoxystrobin is
an endocrine disrupter.

C. Aggregate Exposure

The Agency has concluded from review of available data that there
is no acute toxicological endpoint of concern. Therefore, an acute risk
assessment is not necessary. For azoxystrobin, only a chronic
(noncancer) risk assessment is necessary.
1. Dietary exposure. Permanent tolerances have been established (40
CFR 180.507(a)) for the combined residues of azoxystrobin and its Z
isomer in or on a variety of raw agricultural commodities at levels
ranging from 0.02 ppm on tree nuts to 20.0 ppm on rice hulls. Included
in these tolerances are numerous ones for animal commodities,
established in conjunction with tolerances for rice and wheat
commodities.
i. Food. In conducting this chronic dietary risk assessment,
Syngenta has made the very conservative assumption that 100% of all
commodities having azoxystrobin tolerances or proposed tolerances will
contain azoxystrobin residues at the level of the tolerance. Default
concentration factors have been removed where data show no
concentration of residues (grapes, juice; grapes, raisins; tomatoes,
juice; tomatoes, puree; and potatoes, white (dry)). The chronic
reference dose (RfD) is 0.18 mg/kg/day, derived from the NOAEL of 18.2
mg/kg/day from the rat chronic toxicity/carcinogenicity feeding study
and an uncertainty factor of 100 to allow for interspecies sensitivity
and intraspecies variability.
The Novigen DEEM (Dietary Exposure Evaluation Model) system was
used for this chronic dietary exposure analysis. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1994
through 1996. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function of dietary exposure.
The existing azoxystrobin tolerances (published and pending; FIFRA
section 18 tolerances were excluded in this analysis because most are
included as pending tolerances), result in a theoretical maximum
residue contribution (TMRC) that is equivalent to the following
percentages of the chronic RfD. Because the 10x safety factor was
removed by EPA, the chronic RfD is equal to the PAD (population-
adjusted dose). As a result, the exposure given as a percentage of the
total allowable is reported as %PAD.

------------------------------------------------------------------------
Percent Reference
Population Group/Subgroup Exposure (mg/kg/ Dose1 (%Chronic
day) PAD/RfD)
------------------------------------------------------------------------
U.S. population 0.033665 18.7
------------------------------------------------------------------------
All infants (< 1-year) 0.043793 24.3
------------------------------------------------------------------------
Nursing infants (< 1-year) 0.015041 8.4
------------------------------------------------------------------------
Non-Nursing infants (< 1-year) 0.052206 29.0
------------------------------------------------------------------------
Children (1-6 years old) 0.069628 38.7
------------------------------------------------------------------------
Children (7-12 years old) 0.040975 22.8
------------------------------------------------------------------------
Hispanics 0.038407 21.3
------------------------------------------------------------------------
Non-Hispanic/non-white/non-black 0.046447 25.8
------------------------------------------------------------------------

[[Page 44140]]

Females 13+ (nursing) 0.035904 19.9
------------------------------------------------------------------------
1Percentage reference dose (% chronic PAD) = exposure x 100% (because
RfD=PAD in this case) chronic PAD.

ii. Drinking water. There is no established Maximum Concentration
Level for residues of azoxystrobin in drinking water. No health
advisory levels for azoxystrobin in drinking water have been
established. The concentration of azoxystrobin in surface water is
based on Generic Estimated Environmental Concentration (GENEEC)
modeling and in ground water based on Screening Concentration in Ground
Water (SCI-GROW) modeling.
Based on the chronic dietary (food) exposure estimated, chronic
drinking water levels of concern (DWLOC) for azoxystrobin were
calculated and are summarized in the following table. EPA has estimated
that the highest estimated environmental concentration EEC of
azoxystrobin in surface water is from the application of azoxystrobin
on grapes (39 µg/L). The EEC for ground water is 0.064
µg/L resulting from use on turf. For purposes of risk
assessment the maximum EEC for azoxystrobin in drinking water (39
µg/L) should be used for comparison to the back-calculated
human health drinking water levels of comparison (DWLOC) for the
chronic (noncancer) endpoint. These DWLOCs for various population
categories are summarized in the following table.

----------------------------------------------------------------------------------------------------------------
Maximum Water
Group/Subgroup1 RfD (mg/kg/day) TMRC (food) (mg/kg/ Exposure2 (mg/kg/ DWLOC3, 4, 5(g/L)
day) day)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.18 0.033665 0.146335 5121.725
----------------------------------------------------------------------------------------------------------------
Females 13+ (nursing) 0.18 0.035904 0.144096 4322.88
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.18 0.069628 0.110372 1103.72
----------------------------------------------------------------------------------------------------------------
1 Within each of these categories, the subgroup with the highest food exposure was selected
2 Maximum chronic water exposure (mg/kg/day) = chronic RfD (mg/kg/day) - food exposure (mg/kg/day)
3 DWLOC (µg/L) = maximum water exposure (mg/kg/day) X body wt (kg) (10-3 mg/µg) X water
consumed daily (L/day)
4 HED default body weights are: U.S. population, 70 kg; females (13+ years old), 60 kg; infants and children, 10
kg
5 HED default daily drinking rates are 2 L/day for adults and 1 L/day for children

2. Non-dietary exposure. Azoxystrobin is registered for residential
use on ornamentals and turf. The Agency evaluated the existing
toxicological data base for azoxystrobin and assessed appropriate
toxicological endpoints and dose levels of concern that should be
assessed for risk assessment purposes. Dermal absorption data indicate
that absorption is less than or equal to 4%. No appropriate endpoints
were identified for acute dietary or short-term, intermediate-term, and
chronic term (noncancer) dermal and inhalation occupational exposure.
Therefore, risk assessments are not required for these exposure
scenarios.

D. Cumulative Effects

Azoxystrobin is related to the naturally occurring strobilurins.
Syngenta concluded that further consideration of a common mechanism of
toxicity is not appropriate at this time since there are no data to
establish whether a common mechanism exists with any other substance.

E. Safety Determination

The acute safety analysis was not applicable since no suitable
toxicological end-point of concern was identified during Agency review
of the available data. The short-term and intermediate-term safety
assessment also was not applicable, in this case because no indoor and
outdoor residential exposure uses are currently registered for
azoxystrobin. Therefore, only a chronic analysis was needed.
1. U.S. population. The chronic dietary exposure analysis showed
that exposure from all existing permanent and proposed tolerances,
including those in or on legume vegetables (succulent or dry) group,
hops, grape and tomato for the general U.S. population would be 18.7%
of the RfD.
2. Infants and children. The chronic dietary exposure analysis
showed that exposure from all existing permanent and proposed
tolerances, including those in or on legume vegetables (succulent or
dry) group, hops, grape and tomato for children (1-6 years old), the
subgroup with the highest exposure, would be 38.7% of the RfD.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. In either case, EPA generally defines the
level of appreciable risk as exposure that is greater than 1/100 of the
no observed effect level in the animal study appropriate to the
particular risk assessment. This hundredfold uncertainty (safety)
factor/margin of exposure (safety) is designed to account for combined
interspecies and intraspecies variability. EPA believes that reliable
data support using the standard hundredfold margin/factor but not the
additional tenfold margin/factor when EPA has a complete data base
under existing guidelines and when the severity of the effect in
infants or children or the potency or unusual toxic properties of a
compound do not raise concerns regarding the adequacy of the standard
margin/factor. The Agency ad hoc FQPA Safety Factor Committee removed
the additional 10x safety factor because infants and children are not
believed to have an increased sensitivity to azoxystrobin, compared to
adults.
Syngenta has considered the potential aggregate exposure from food,
water, and non-occupational exposure routes and concludes that
aggregate exposure is not expected to exceed 100% of the RfD and that
there is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to azoxystrobin residues.

F. International Tolerances

There are no Codex Maximum Residue Levels established for
azoxystrobin.
[FR Doc. 01-21048 Filed 8-21-01; 8:45 am]
BILLING CODE 6560-50-S

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

Local Navigation