FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Trifloxystrobin Index Page
Trifloxystrobin (Bayer). August 31, 2001. Pesticide Tolerance Petition. Federal Register.
Note from EC:
Trifloxystrobin CAS Name: Benzeneacetic acid, (E,E)-a-(-(methoxyimino)
-2[[[[1-[3-trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]-,methylester
Note: The predominant metabolite is trifluoroacetic acid: CGA-321113.
On Sept. 27, 1999, US EPA establihsed Tolerances for combined residues of
trifloxystrobin and the free form of its acid metabolite CGA-321113 ((E,E)-
methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-
ethylideneaminooxymethyl]-phenyl]acetic acid
See: http://www.epa.gov/fedrgstr/EPA-PEST/1999/September/Day-27/p25050.htm
http://www.epa.gov/fedrgstr/EPA-PEST/2001/August/Day-31/p22025.htm
[Federal Register: August 31, 2001 (Volume 66, Number 170)]
[Notices]\
[Page 45988-45993]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au01-50]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-1040;FRL-6797-6]
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.
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SUMMARY: This notice announces the initial filing of a pesticide
petition 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-1040, must be
received on or before October 1, 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-1040 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-7704; 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 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.
[[Page 45989]]
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'' ``Regulations and Proposed Rules,'' 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-1040. 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-1040 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-1040. 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 pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of certain
pesticide chemicals 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 these petitions contain 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: August 16, 2001.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summaries of Petitions
Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them 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.
Bayer Corporation
0F6121
Summary of Petitions
EPA has received a pesticide petition (0F6121) from Bayer
Corporation, 8400 Hawthorne Road, P. O. Box 4913, Kansas City, MO
64121-0013 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
[[Page 45990]]
180 by establishing a tolerance for residues of trifloxystrobin in or
on the raw agricultural commodity barley grain at 0.05 parts per
million (ppm), straw at 0.05 ppm, barley hay at 0.2 ppm, citrus fruits
group at 0.3 ppm, citrus oil at 7.0 ppm, corn forage at 0.05 ppm, corn
stover at 7.0 ppm, aspirated grain fractions at 0.1 ppm, popcorn grain
at 0.05 ppm, popcorn stover at 7.0 ppm, pecans at 0.05 ppm, rice grain
at 3.5 ppm, rice straw at 7.5 ppm, stone fruits crops group at 2.0 ppm,
and poultry (fat, kidney, liver, meat by-products, meats at 0.5 ppm).
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 supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Residue metabolism. The metabolism of trifloxystrobin in plants
(cucumbers, apples, wheat, sugar beets and peanuts) is well understood.
Identified metabolic pathways are substantially similar in plants and
animals (goat, rat and hen). EPA has determined that trifloxystrobin
parent and its metabolite CGA-321113 are the residue of concern for
tolerance setting purposes.
2. Analytical method. A practical analytical methodology for
detecting and measuring levels of trifloxystrobin in or on raw
agricultural commodities has been submitted. The limit of detection
(LOD) for each analyte of this method is 0.08 ng injected, and the
limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop
specific cleanup procedures and determination by gas chromatography
with nitrogen-phosphorous detection.
3. Magnitude of residues. Residue trials were performed for
trifloxystrobin on a full geography of Citrus Fruit Crop Group (with
oranges, lemons and grapefruit as representative citrus fruit crops),
field corn, popcorn, and rice as representative crops from the cereal
grain group, pecans, and Stone Fruits Crop Group (with peaches, plums,
tart and sweet cherries as representative stone fruit crops). A study
was conducted on indicator crops to assay for secondary residues in
rotational crops. A three-level ruminant and poultry study was
completed to determine the rate of transfer of residues of
trifloxystrobin from residues in animal feed to ruminant and poultry
commodities.
B. Toxicological Profile
1. Acute Toxicity. Studies conducted with the technical material of
trifloxystrobin:
Rat acute oral toxicity study with a LD50
>5,000 mg/kg
Mouse acute oral toxicity study with a LD50
>5,000 mg/kg
Rabbit acute dermal toxicity study with a LD50
>2,000 mg/kg
Rat acute dermal toxicity study with a LD50
>2,000 mg/kg
Rat acute inhalation toxicity study with a LC50
>4.65 mg/L
Rabbit eye irritation study showing slight irritation
(Category III)
Rabbit dermal irritation study showing slight irritation
(Category IV)
Guinea pig dermal sensitization study with Buehler's
method showing negative findings
Guinea pig dermal sensitization study with the
Maximization method showing some positive findings
2. Genotoxicity. No genotoxic activity is expected of
trifloxystrobin under in vivo or physiological conditions. The compound
has been tested for its potential to induce gene mutation and
chromosomal changes in five different test systems. The only positive
finding was seen in the in vitro test system (Chinese hamster V79
cells) as a slight increase in mutant frequency at a very narrow range
(250 - 278 µg/ml) of cytotoxic and precipitating concentrations
(compound solubility in water was reported to be 0.61 µg/ml;
precipitation was visually noted in culture medium at 150 µg/
ml). The chemical was found to be non-mutagenic in the in vivo system
or all other in vitro systems. Consequently, the limited gene mutation
activity in the V79 cell line is considered a nonspecific effect under
non-physiological in vitro conditions and not indicative of a real
mutagenic hazard.
3. Reproductive and developmental toxicity. FFDCA section 408
provides that EPA may apply an additional safety factor for infants and
children in the case of threshold effects to account for pre- and post-
natal toxicity and the completeness of the database. Based on the
current toxicological data requirements, the database on
trifloxystrobin relative to pre- and post-natal effects for children is
complete.
In assessing the potential for additional sensitivity of infants
and children to residues of trifloxystrobin, data were considered from
teratogenicity studies in the rat and the rabbit and a 2-generation
reproduction studies in the rat. The teratogenicity studies were
designed to evaluate adverse effects on the developing embryo as a
result of chemical exposure during the period of organogenesis.
Reproduction studies provide information on effects from chemical
exposure on the reproductive capability of mating animals and systemic
and developmental toxicity from in-utero exposure.
In the rat teratology study, reductions in body weight gain and
food consumption were observed in the dam at 3100 mg/kg. No
teratogenic effects or any other effects were seen on pregnancy or
fetal parameters except for the increased incidence of enlarged thymus,
which is a type of variation, at 1,000 mg/kg. The developmental NOAEL
was 100 mg/kg.
In the rabbit teratology study, body weight loss and dramatically
reduced food consumption were observed in the dam at 32,050
mg/kg. No teratogenic effects or any other effects were seen on
pregnancy or fetal parameters except for the increase in skeletal
anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/
kg. This finding is regarded as a marginal effect on skeletal
development that could have resulted from the 40-50% lower food intake
during treatment at this dose level. The developmental NOAEL was 250
mg/kg.
In the 2-generation rate reproduction study, body weight gain and
food consumption decreased at 3750 ppm, especially in females
during lactation. Consequently, the reduced pup weight gain during
lactation (3750 ppm) and the slight delay in eye opening
(1,500 ppm) are judged to be a secondary effect of maternal toxicity.
No other fetal effects or any reproductive changes were noted. The low
developmental NOAEL, 50 ppm (5 mg/kg), seen in this study was probably
due to the lack of intermediate dose levels between 50 and 750 ppm.
Based on an evaluation of the dose-response relationship for pup weight
at 750 ppm and 1,500 ppm, the NOAEL should have already been nearly
ten-fold higher if such a dose was available.
Based on all these teratology and reproduction studies, the lowest
NOAEL for developmental toxicity is 5 mg/kg while the lowest NOAEL in
the subchronic and chronic studies is 2.5 mg/kg/day (from the rat
chronic study). Therefore, no additional sensitivity for infants and
children to trifloxystrobin is suggested by the database.
4. Subchronic toxicity. In subchronic studies, several mortality
related changes were reported for the top dose in dogs (500 mg/kg) and
rats (800 mg/kg). At these dose levels, excessive toxicity has resulted
in body weight loss and mortality with the associated and nonspecific
changes in several organs
[[Page 45991]]
(such as atrophy in the thymus, pancreas, bone morrow, lymph node, and
spleen) which are not considered specific target organs for the test
compound. In the dog, specific effects were limited to hepatocellular
hypertrophy at 3150 mg/kg and hyperplasia of the epithelium
of the gall bladder at 500 mg/kg. Target organ effects in the rat were
noted as hepatocellular hypertrophy (3200 mg/kg) and the
related liver weight increase (350 mg/kg). In the mouse,
target organ effects included single cell necrosis (3300 mg/
kg) and hypertrophy (1,050 mg/kg) in the liver and extramedullary
hematopoiesis (3300 mg/kg) and hemosiderosis in the spleen
(1,050 mg/kg).
In general, definitive target organ toxicity, mostly in the liver,
was seen at high feeding levels of over 100 mg/kg for an extended
treatment period. At LOAEL, no serious toxicity was observed other than
mostly non-specific effects including a reduction in body weight and
food consumption or liver hypertrophy.
5. Chronic toxicity. The liver appears to be a major primary target
organ based on the chronic studies conducted in mice, rats, and dogs.
It was identified as a target organ in both the mouse and the dog
studies with trifloxystrobin. However, no liver effect was seen in the
chronic rat study which produced the lowest NOAEL of 2.5 mg/kg based on
reduced body weight gain and food consumption seen at higher dose
levels.
The compound did not cause any treatment-related increase in
general tumor incidence, any elevated incidence of rare tumors, or
shortened time to the development of palpable or rapidly lethal tumors
in the 18-month mouse and the 24-month rat studies. Dosages in both
studies were sufficient for identifying a cancer risk. In the absence
of carcinogenicity, a Reference Dose approach is appropriate for
quantitation of human risks.
6. Animal metabolism. Trifloxystrobin is moderately absorbed from
the gastrointestinal tract of rats and is rapidly distributed.
Subsequent to a single oral dose, the half life of elimination is about
2 days and excretion is primarily via bile. Trifloxystrobin is
extensively metabolized by the rat into about 35 metabolites, but the
primary actions are on the methyl ester (hydrolysis into an acid), the
methoxyimino group (O-demethylation), and the methyl side chain
(oxidation to a primary alcohol). Metabolism is dose dependent as it
was almost complete at low doses but only about 60% complete at high
doses.
In the goat, elimination of orally administered trifloxystrobin is
primarily via the feces. The major residues were the parent compound
and the acid metabolite (CGA-321113) plus its conjugates. In the hen,
trifloxystrobin is found as the major compound in tissues and in the
excreta, but hydroxylation of the trifluormethyl-phenyl moiety and
other transformations, including methyl ester hydrolysis and
demethylation of the methoxyimino group, are also seen. In conclusion,
the major pathways of metabolism in the rat, goat, and hen are the
same.
7. Metabolite toxicology. Metabolism of trifloxystrobin has been
well characterized in plants, soil, and animals. In plants and soil,
photolytically induced isomerization results in a few minor metabolites
not seen in the rat; however, most of the applied materials remained as
parent compound as shown in the apple and cucumber studies. All
quantitatively major plant and/or soil metabolites were also seen in
the rat. The toxicity of the major acid metabolite, CGA-321113 (formed
by hydrolysis of the methyl ester), has been evaluated in cultured rat
hepatocytes and found to be 20-times less cytoxic than the parent
compound. Additional toxicity studies were conducted for several minor
metabolites seen uniquely in plants and/or soil. The studies indicate
that these metabolites, including CGA-357261, CGA-373466, and NOA-
414412, are not mutagenic to bacteria and are of low acute toxicity
(LD50 >2,000 mg/kg). In conclusion, the metabolism and
toxicity profiles support the use of an analytical enforcement method
that accounts for parent trifloxystrobin.
8. Endocrine disruption. CGA-279202 does not belong to a class of
chemicals known for having adverse effects on the endocrine system.
Developmental toxicity studies in rats and rabbits and reproduction
study in rats gave no indication that CGA-279202 might have any effects
on endocrine function related to development and reproduction. The
subchronic and chronic studies also showed no evidence of a long-term
effect related to the endocrine system.
i. Dietary exposure-- a. Food. Acute and chronic dietary exposure
assessments were performed on the crops that are the subject of this
petition using field trial residue values on the citrus and stone fruit
crop groups, corn, rice, barley, and pecans. In addition, established
uses on sugar beets, almonds, fruiting vegetable (crop group), pome
fruit (crop group), cucurbits (crop group), bananas, grapes, peanuts,
potatoes, hops, and wheat were included in the assessment. All residues
were generated from field trials conducted with a minimum pre-harvest
interval and maximum application rate. In addition, if market share
data were available, residues were adjusted for the percent crop
treated. The residues in processed potatoes, sugar beets (molasses),
tomatoes, oranges (juice), apples (juice), corn, rice, wheat fractions,
peanuts, and grapes (juice) were adjusted using experimentally
determined processing factors generated from processing studies. For
all other processed fractions, USDA default processing factors were
utilized. Residues in animal commodities were calculated from
theoretical dietary burden calculations and transfers factors obtained
from livestock and poultry feeding studies. Assessments were conducted
utilizing the Dietary Exposure Evaluation Model (DEEM) from
Novigen Sciences and the 1994-96 Continuing Survey of Food Intake by
Individuals (CSFII). Acute exposure for the U.S. population and all
population subgroups were compared to an acute reference dose (aRfD) of
2.5 mg/kg/day based on a developmental no-observable adverse effect
level (NOAEL) in rabbits and a 100-fold uncertainty factor. Although
this endpoint is applicable to females only in the strictest sense, the
developmental NOAEL was used for all populations due to the lack of a
suitable toxicological endpoint. Chronic exposure was compared to a
chronic RfD of 0.05 mg/kg/day based on a chronic study in dogs and a
100-fold uncertainty factor. Both acute and chronic toxicological
endpoints were taken from the final pesticide tolerance rule for
trifloxystrobin published in the Federal Register of September 27, 1999
(OPP-300922; FRL-6382-5).
Both acute and chronic exposure was minimal in all population
subgroups. The acute results were obtained from a probabilistic, 1,000-
iteration Monte Carlo assessment. Acute exposure was expressed at the
99.9th percentile of exposure and ranged from 0.17% to 0.08% of the
aRfD with non-nursing infants (less than 1 year old) as the most
sensitive population subgroup (0.80% of the RfD). The chronic exposure
assessment was conducted by taking the mean field trial residue values
and comparing to average daily consumption values. Chronic exposure
ranged from 0.2% to 1.2% of the chronic RfD and the most sensitive
population was non-nursing infants (less than 1 year old).
b. Drinking water--Estimated surface water concentration. The
generic expected environmental concentration (GENEEC) estimated surface
water
[[Page 45992]]
concentrations for trifloxystrobin uses contributed little to the over
exposure. These estimated concentrations were not adjusted for the
estimated market share of percentage of use area. The highest day-56
expected environmental concentration (EEC) value was 0.27 parts per
billion (ppb) provided by the established trifloxystrobin turf use.
According to the EPA ``OPP's Interim Approach for Addressing Drinking
Water Exposure,'' the average day-56 value is divided by three when
correcting for overestimation of the GENEEC model. The EPA has accepted
that the average day-56 EEC value is divided by six in the case when
the product is applied to turf and accounts for the effects of grass/
turf in decreasing runoff (EPA, 1998. EPA-730-F97-2, PB97-137806, page
15). This division by six was used to calculate the potential exposure
via surface water from the trifloxystrobin turf application, 0.27 ppb/
6=0.045 ppb.
Estimated ground water concentrations. The SCI-GROW estimated
ground water concentrations for trifloxystrobin uses also contributed
little to the overall exposure. The estimated concentrations were not
adjusted for the estimated market share or percentage of use area. In
each use scenario, the concentration of trifloxystrobin in ground water
was predicted to be below 1 part per trillion. The highest estimated
concentration of trifloxystrobin in the ground water was 0.000859 ppb
provided by the trifloxystrobin turf use.
c. Drinking water levels of concern--Acute exposure. Based on the
EPA's ``Interim Guidance for Conducting Drinking Water Exposure and
Risk Assessments'' document (drafted 12/2/97), acute drinking water
levels of comparison (DWLOCacute) were calculated for
trifloxystrobin. The lowest acceptable Margin of Exposure (MOE) for any
pesticide is 100. This value was used in the DWLOC calculations. Based
on this analysis, the maximum estimated trifloxystrobin surface water
at Peak Day-0 (2.54 ppb) and ground water (0.000859 ppb)
concentrations, human drinking water exposures do not exceed the
calculated acute DWLOC values (µg/L:24,8000 to 87,325).
Therefore, acute human drinking water exposures to trifloxystrobin from
the existing and newly proposed uses would not exceed the exposure
allowable by the risk cup. From the acute dietary exposure analysis
provided for the trifloxystrobin dietary assessment, the acute drinking
water levels of comparison (DWLOCacute) were calculated for
CGA-32113. Based on this analysis, the maximum estimated CGA-32114 in
surface water at Peak Day-0 (38.73 ppb) and in ground water (4.944316
ppb) concentrations, human drinking water exposures do not exceed the
calculated acute DWLOC values (µg/L:24800 to 87150). Therefore,
acute human drinking water exposures to CGA-32114 from the existing and
newly proposed trifloxystrobin uses would not exceed the exposure
allowable by the risk cup.
Chronic exposure. The chronic drinking water levels of comparison
(DWLOCchronic) were calculated for trifloxystrobin. The
maximum estimated trifloxystrobin surface water (0.09 ppb) and ground
water (0.000859 ppb) concentrations do not exceed the calculated
chronic DWLOC values (µg/L:494 to 1747). Therefore, chronic
human drinking water exposures to the existing and newly proposed
trifloxystrobin uses would not exceed the exposure allowable by the
risk cup. From the chronic dietary exposure analysis provided for the
trifloxystrobin dietary assessment, the chronic drinking water levels
of comparison (DWLOCchronic) were calculated for CGA-32113.
Based on this analysis, the maximum estimated CGA-32113 in surface
water at Day 56/3 (12.24 ppb) and in ground water (0.989 ppb)
concentrations, human drinking water exposures do not exceed the
calculated chronic DWLOC values (µg/L:494 to 1,745). Therefore,
chronic human drinking water exposures to the existing and newly
proposed trifloxystrobin uses would not exceed the exposure allowable
by the risk cup.
ii. Non-dietary exposure. Non-dietary exposure to trifloxystrobin
is considered negligible as the chemical is intended primarily for
commercial and agricultural use. Post-application re-entry exposure to
homeowners from professional use on residential ornamentals is
considered negligible. For workers handling this chemical, acceptable
margins of exposure (in the range of thousands) have been obtained for
both acute and chronic scenarios.
D. Cumulative Effects
Consideration of a common mechanism of toxicity is not appropriate
at this time since there is no information to indicate that toxic
effects produced by trifloxystrobin would be cumulative with those of
any other types of chemicals. Furthermore, the oximinoacetate is a new
type of fungicide and no compound in this general chemical class
currently has a significant market share. Consequently, aggregate risk
is the only potential exposure to trifloxystrobin.
E. Safety Determination
1. U.S. population. To calculate acute aggregate risk, high-end
exposures from food and drinking water sources are compared to the
acute population adjusted dose (aPAD). Exposure to trifloxystrobin
residues and the free form of its acid metabolite, CGA-321113 in food
will occupy <1% of the aPAD for females 13+ years old (nursing). Acute
dietary risk was calculated for females 13+ years old because the
endpoint upon which the aPAD is based is on developmental effects.
Estimated drinking water levels were calculated using drinking water
models (SCI-GROW and GENEEC), and the values are considered
overestimates due to the conservative assumptions built into the
models. Estimated concentrations of trifloxystrobin residues in surface
and ground water are lower than EPA's DWLOCs. Therefore, it is not
expected that acute aggregate risk to trifloxystrobin residues from
acute food and drinking water sources will exceed EPA's level of
concern for acute aggregate risk.
Chronic exposure to residues of trifloxystrobin and the free form
of its acid metabolite, CGA-321113, in food will occupy less than 0.5%
of the chronic population adjusted dose (cPAD) for adult population
subgroups (females 13+/nursing) and no more than 2.0% of the cPAD for
infant/children subgroups (highest subgroup: non-nursing infants).
Estimated concentrations of trifloxystrobin residues in surface and
ground water are lower than EPA's DWLOCS. Estimated drinking water
levels were calculated using drinking water models, and the values are
considered overestimates due to the conservative assumptions built into
the models. EPA has previously determined chronic residential exposure
of trifloxystrobin is not expected. The established and pending uses of
trifloxystrobin when combined in a chronic aggregate risk assessment
for food, water and residential sources will not exceed EPA's level of
concern for chronic aggregate risk.
Bayer concludes that there is a reasonable certainty that no harm
will result from aggregate exposure to trifloxystrobin residue.
2. Infants and children. On June 21, 1999, the EPA FQPA Safety
Factor Committee determined the 10x safety factor for the protection of
infants and children should be removed for trifloxystrobin. The
Committee's rationale for removing the FQPA Safety Factor is as
follows:
[[Page 45993]]
i. The trifloxystrobin toxicology database is complete for FQPA
assessment.
ii. There is no indication of increased susceptibility of rat or
rabbits to trifloxystrobin.
In the developmental and reproductive toxicity studies, effects in
the fetuses/offspring were observed only at or above treatment levels
which resulted in evidence of parental toxicity.
Using the same exposure assumptions as employed for the
determination in the general population, it has been calculated that
the percent of the RfD that will be utilized by aggregate exposure to
residues of trifloxystrobin is <2.0% for non-nursing infants (<1 year
old)(the most impacted sub-population). Therefore, based on the
completeness and reliability of the toxicity data base and the
conservative exposure assessment, Bayer concludes that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to trifloxystrobin residues.
F. International Tolerances
No Codex MRLs have been established for residues of
trifloxystrobin.
[FR Doc. 01-22025 Filed 8-30-01; 8:45 am]
BILLING CODE 6560-50-S