[Federal Register Volume 67, Number 50 (Thursday, March 14, 2002)]
[Notices]
[Pages 11476-11480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6156]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1071; FRL-6825-1]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1071, must be 
received on or before April 15, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1071 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Mary L. Waller, Fungicide 
Branch, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9354; 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-1071. 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

[[Page 11477]]

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-1071 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1071. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: February 28, 2002.
Peter Caulkins,
Acting 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 Aventis CropScience, and represents the view 
of the petitioners. 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.

Aventis CropScience

PP 9F6051

    EPA has received a pesticide petition (9F6051) from Aventis 
CropScience, 2 TW Alexander Drive, Research Triangle Park, NC 27709 
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, by 
establishing tolerances for combined residues of the fungicide 
triticonazole 5-[(4- chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol), and its metabolites, 5-[(4-
chlorophenyl)methylene]-2-hydroxymethyl-2-methyl-1-(1H-1,2,4-triazol- 
1ylmethyl)cyclopentanol (RPA 404886) and 5-[(4-chlorophenyl)methylene]-
2,2-dimethyl-1-(1H- 1,2,4-triazol-1ylmethyl)cyclopentan-1,3-trans-diol 
(RPA 406341)] in or on the raw agricultural commodities wheat grain at 
0.05 parts per million (ppm), wheat forage at 0.05 ppm, wheat hay at 
0.05 ppm, wheat straw at 0.05 ppm, barley grain at 0.05 ppm, barley 
forage at 0.05 ppm, barley hay at 0.05 ppm, and barley straw at 0.05 
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.

[[Page 11478]]

A. Residue Chemistry

    1. Plant metabolism. Metabolism studies in wheat and barley were 
conducted using both phenyl-ring and triazole-ring labeled material in 
order to fully define the metabolic fate of triticonazole. Treatment 
regimes were chosen to simulate a commercial seed treatment 
application. The results from both crops were similar. Hydroxylation is 
the primary route of metabolism with the carbons of the cyclopentane 
ring and the methyl groups being the sites susceptible to oxidative 
degradation.
    2. Analytical method. The plant metabolism studies indicated that 
analysis for the parent compound, triticonazole, and the metabolites 
RPA 404886 and RPA 406341 was sufficient to enable the assessment of 
the relevant residues in wheat and barley. Following extraction of the 
crop matrix and sample cleanup, the analytical enforcement method 
relies on the use of Turbo Ionspray, liquid chromatography/mass 
spectroscopy (LC/MS) for determination of the residue level. This 
method allows detection and measurement of residues in or on 
agricultural commodities at or above the proposed tolerance level. 
Analysis using Electrospray, liquid chromatography/ mass spectroscopy/
mass spectroscopy (LC/MS/MS) is more sensitive, and allows quantitation 
of analytes down to 0.005 ppm.
    3. Magnitude of residues. Field residue trials were conducted 
across the major regions of small-grain cereal production in the United 
States. The treatment regime was selected to represent the use pattern 
that is the most likely to result in the highest residues.
     Trials to define the magnitude of the residues in wheat raw 
agricultural commodity, were conducted at 22 trial sites of which 13 
used spring wheat varieties and 9 used fall wheat varieties. The wheat 
seeds were treated with a triticonazole formulation at a rate of 
approximately 10 g active ingredient (a.i.)/100 kg wheat seed, a rate 
twice that anticipated under commercial use practice. Generally, the 
level of triticonazole residues observed in the samples were very low. 
For wheat forage, the residue of triticonazole found in or on the 
samples did not exceed 0.02 ppm; whereas, the residues for wheat hay 
did not exceed 0.008 ppm and the residues for wheat straw did not 
exceed 0.007 ppm. Triticonazole was not detected (method detection 
limit (MDL) = 0.002 ppm) in or on the wheat grain samples, except in 
one of the two replicate samples from one trial site where the residue 
level was determined to be 0.0055 ppm. Residues of the metabolites were 
not detected (MDL = 0.002 ppm) in any forage, hay grain or straw 
samples, except at one site where residues of RPA 406341 in the straw 
were just above the MDL but less than the limit of quantification (LOQ) 
of the method.
     Trials to define the magnitude of the residues in the raw 
agricultural commodity barley were conducted at 14 trial sites of which 
12 used spring wheat varieties and 2 used fall wheat varieties. The 
barley seeds were treated as described above for wheat. No residues of 
triticonazole or metabolites were detected (MDL = 0.002 ppm) in or on 
the barley grain samples. In the barley hay samples, no residues of 
triticonazole or metabolites were detected above the LOQ of the method 
(0.005 ppm), except at one site where the mean level of triticonazole 
in the duplicate samples was 0.0058 ppm. Similarly, in the straw, no 
residues of triticonazole or metabolites were detected above the LOQ of 
the method except in one replicate at one site where triticonazole was 
found at 0.0067 ppm.
     Studies were conducted to determine if triticonazole residues 
concentrated upon processing wheat or barley grain. The wheat or barley 
seeds used for these studies were treated at a nominal rate of 50 g 
a.i./100kg wheat seed, a rate 10 times that anticipated under 
commercial use practice. Grain samples were collected at normal 
commercial maturity. Using procedures that simulate commercial 
practices, wheat grain was processed into bran, flour, middlings, 
shorts, and germ; whereas barley grain was processed into bran, flour, 
or pearled barley. Using LC/MS/MS, the LOQ and MDL for triticonazole 
and metabolites were 0.005 ppm and 0.002 ppm, respectively, for all 
matrices. Triticonazole-related residues were below the MDL for all 
grain and processed fraction samples. Based on these results, residues 
of triticonazole and metabolites do not concentrate in wheat or barley 
processed fractions following a triticonazole seed treatment 
application.

B. Toxicological Profile

    1. Acute toxicity. Triticonazole is of low acute toxicity placing 
the active ingredient in Toxicity Category III and IV. Triticonazole is 
non-irritating to the eyes and skin and is not a skin sensitizer.
    2. Genotoxicty. The genetic toxicity of triticonazole has been 
evaluated through a full battery of mutagenicity assays. Triticonazole 
was not mutagenic or genotoxic in any assay in either the presence or 
absence of metabolic activation.
    3. Reproductive and developmental toxicity. Triticonazole is not a 
reproductive or developmental toxicant.
    a. Teratology - rat. Groups of at least 23 pregnant rats received 
daily oral doses of 0, 40, 200 or 1,000 mg/kg/day of triticonazole from 
day 6 to day 15 of gestation inclusive. The mean weight gain and the 
food intake of females receiving 1,000 mg/kg/day was marginally lower 
than that of the controls. Litter size, survival in utero and mean 
fetal and placental weights were unaffected by treatment. There were no 
major abnormalities or visceral abnormalities at any dosage used. The 
mean weight gain and the food intake of females receiving 1,000 mg/kg/
day was marginally lower than that of the controls. Females at 40 and 
200 mg/kg/day were unaffected.
     There was an apparent increase in the incidence of fetuses with an 
additional 14th rib or pair of ribs at 1,000 mg/kg/day. The incidences 
at 40 and 200 mg/kg/day were within the historical control range. 
Because the increased incidence of supernumerary (14th) ribs is not 
toxicologically significant, the NOAEL for maternal and developmental 
toxicity was 1,000 mg/kg/day.
    b. Teratology - rabbit. Triticonazole was administered by gavage to 
4 groups of at least 18 pregnant New Zealand white rabbits at dosages 
of 5, 25, 50 or 75 mg/kg/day, from Day 6 to Day 19 of gestation 
inclusive. Administration of 25 mg/kg/day was associated with body 
weight reduction and reduced food intake. At 50 and 75 mg/kg/day more 
marked body weight loss, reduced food intake and deaths were observed. 
Slightly increased pre-implantation and post-implantation losses and 
increased incidences of skeletal anomalies were observed at 75 mg/kg, 
secondary to severe maternal toxicity (6 animals died out of 20). The 
NOAEL for maternal toxicity was 25 milligrams/kilogram of body weight/
day (mg/kg bwt/day) based on reduced body weight gains and food 
consumption at 50 mg/kg bwt/day. The NOAEL for fetal development was 50 
mg/kg bwt/day, based on skeletal abnormalities noted in the presence of 
severe maternal toxicity at 75 mg/kg bwt/day.
    c. Two-generation reproduction - rat. Groups of 28 males and 28 
females Crl:CD BR/VAF/Plus rats (F0) were offered diets containing 0, 
5, 25, 750 and 5,000 ppm of triticonazole for 10 weeks before mating 
and throughout gestation, lactation and weaning of the pups. A second 
generation of selected pups (F1) was provided diets at the same 
concentrations as their parents from weaning for at least 10 weeks 
before mating and throughout mating,

[[Page 11479]]

gestation and lactation. The NOAEL for systemic toxicity is 750 ppm, 
based on mortality, decreased body weight gain, and food consumption 
seen in the high dose animals in both generations. The NOAEL for 
reproductive performance and fetal effects is also 750 ppm, based on a 
reduction in mating and fertility indices, number of live births, pup 
viability and pup body weights at 5,000 ppm.
    4. Subchronic toxicity--i. 28-day dietary - rat. Groups of five 
male and five female F-344 rats received triticonazole continuously, 
via the diet, at concentrations of 0, 500, 1,500, 5,000, 15,000 or 
50,000 ppm (0, 50, 150, 500, 1,500, and 5,000 mg/kg/day, respectively 
for 4-weeks. At 5,000 ppm (500 mg/kg/day) growth performance, food 
consumption and efficiency of food utilization of males were inferior 
to control values throughout the treatment period. Hematological 
investigations revealed low platelet counts in males. Blood chemistry 
investigations revealed minimally low glucose concentrations. High 
liver weights and low prostate and uterus weights were noted at 
necropsy. The NOAEL for systemic toxicity was 1,500 ppm (150 mg/kg/
day).
    ii. 90-day dietary - rat. Four groups of 10 male and 10 female CD 
rats received triticonazole via the diet at concentrations of 25, 250, 
12,500 or 25,000 ppm (2.5, 25, 1,250, or 2,500 mg/kg/day) for 13 weeks. 
The NOAEL for this study was 12,500 ppm (1,250 mg/kg/day) based on 
reduced body weight gain, food consumption, and histopathological 
changes in the liver and adrenals.
    c. Dermal toxicity evaluation. No adverse effects were noted in 
rats at the limit dose of 1,000 mg/kg bwt/day.
    5. Chronic toxicity - dog. a. Four groups of 4 male and 4 female 
beagle dogs received triticonazole in gelatin capsules at dosages 2.5, 
25 and 150 mg/kg/day. A similar control group received only empty 
gelatin capsules. The NOAEL for this study was 25 mg/kg bwt/day based 
on clinical signs of toxicity, lower for body weight gains; organ 
weight changes and histopathological changes of the liver and adrenals 
were seen at the LOAEL of 150 mg/kg/day.
    b. Combined chronic toxicity/oncogenicity - rat. Four groups of 50 
males and 50 females CD rats were administered triticonazole via the 
diet at concentrations of 5, 25, 750 and 5,000 ppm for 2-years. 
Observed adverse effects were only at the highest dose of 5,000 ppm 
with decreased body weight gain in females and histopathological 
changes in the adrenals. The NOAEL for this study was 750 ppm that is 
equivalent to 29.4 and 38.3 mg/kg/day respectively for males and 
females.
    c. Oncogenicity - mouse. Triticonazole was administered via the 
diet to four groups of 52 male and 52 female CD mice at concentrations 
of 0, 15, 150 and 1,500 ppm for 78 weeks. The NOAEL was 150 ppm (17.4 
and 20.1 mg/kg for males and females respectively) based on reductions 
in body weight gain, increased relative and absolute liver weights and 
histopathological changes in the liver at 1,500 ppm. There were no 
treatment-related neoplasms in this study.
    6. Neurotoxicity--a. Acute neurotoxicity. Groups of 10 male and 10 
female rats were dosed once by oral gavage at dose levels of 0, 80, 
400, or 2,000 mg/kg of triticonazole in a methyl cellulose suspension. 
There were no differences observed in body weight, in any of the 
functional observation battery (FOB), or in motor activity. Microscopy 
revealed no changes related to the administration of triticonazole. 
Therefore, the NOAEL for acute neurotoxicity exceeds 2,000 mg/kg.
    b. Subchronic neurotoxicity. Groups of 10 male and 10 female rats 
received basal diet containing triticonazole at inclusion levels of 0, 
500, 2,500 or 10,000 ppm (0, 33, 170 and 695 mg/kg/day in the males, 
and 0, 39, 199 and 820 mg/kg/day in the females). There were no 
differences observed in bodyweight, in any of the FOB, or in motor 
activity. Microscopy revealed no changes related to the administration 
of triticonazole. Therefore, the NOAEL for sub-acute neurotoxicity 
exceeds 10,000 ppm (exceeds 695 mg/kg/day) in the rat.
    7. Animal metabolism. Studies conducted in cows and hens using 
14C-triticonazole indicate the majority of the radioactivity 
is rapidly excreted with almost a negligible amount transferred to 
tissues, milk or eggs. Hyrdoxylation represented the primary metabolic 
pathway with the carbon atoms on the cyclopentane and those of the 
methyl groups being the sites of attack. Principal metabolites included 
RPA 406341 and RPA 404886 and a metabolite in which the hydroxymethyl 
group of RPA 404886 was further oxidized to a carboxylic acid function.
    8. Endocrine disruption. No studies have been conducted to 
investigate the potential of triticonazole to induce estrogenic or 
other endocrine effects. The EPA has not yet developed the criteria it 
will use for characterizing endocrine disrupting substances. Therefore, 
an evaluation of the potential of triticonazole to induce estrogenic or 
other endocrine effects cannot be conducted at this time.

C. Aggregate Exposure

    1. Dietary exposure. Tolerances are proposed under 40 CFR part 180 
for the combined residues of triticonazole and metabolites in or on 
wheat grain, forage, straw, and hay, and in or on barley grain, forage, 
straw, and hay. The registration of triticonazole for control of fungal 
diseases in turf (non-food use) is pending at EPA. The turf use is for 
application by professional applicators, and does not include use on 
residential turf. Therefore, potential non-occupational (residential) 
exposure would include exposures resulting from consumption of 
potential residues in food and water only.
    i. Food. Potential dietary exposures from food were estimated using 
the DEEM software system (Novigen Sciences, Inc.) and the 1994-96 USDA 
consumption data. Residue data from field trial studies in which grain 
grown from triticonazole treated barley and wheat seed was used to 
estimate chronic and acute dietary exposure. Percent crop treated 
values include the total amount of barley and wheat treated with any 
seed treatment pesticide, and thus, are conservative. Metabolism 
studies show that triticonazole residues are not expected in livestock 
tissues from animals fed at levels found in treated seed feed items. 
Tier 3 chronic exposure for the overall U.S. population was estimated 
to be 0.000002 mg/kg/bwt/day, representing less than 0.1% of the 
chronic reference dose. Chronic exposure for the most highly exposed 
population subgroup, children 1-6 years of age, was calculated to be 
0.000004 mg/kg/bwt/day, also less than 0.1% of the chronic reference 
dose.
    Tier 3 acute exposure at the 99.9th percentile for the 
overall U.S. population was estimated to be 0.000017 mg/kg/bwt/day, 
less than 0.1% of the acute reference dose. Acute exposure for the most 
highly exposed population subgroup, again children 1-6 years old, was 
estimated to be 0.00002 mg/kg/bwt/day, less than 0.1% of the acute 
reference dose. These analyses represent worst case estimates of 
potential dietary exposure to wheat and barley. Any exposure from 
residues of triticonazole in the diet are likely to be negligible to 
non-existent in real world situations.
    ii. Drinking water. EPA's standard operating procedure (SOP) for 
drinking water exposure and risk assessments was used to perform the 
drinking water assessment. This SOP uses a variety of tools to conduct 
drinking water assessment. These tools include water models such as 
screening concentration in ground water (SCI-GROW), generic

[[Page 11480]]

expected environmental concentration (GENEEC), pesticide root zone 
management system/exposure analysis modeling system (PRZMS/EXAMS), and 
monitoring data. If monitoring data are not available, then the models 
are used to predict potential residues in surface and ground water, and 
the highest residue is assumed to be the drinking water residue. In the 
case of triticonazole, monitoring data do not exist; therefore, GENEEC 
was used to estimate the concentration of triticonazole that might 
occur in water. The GENEEC values represent very conservative 
assumptions and worst case scenarios. The calculated drinking water 
levels of comparison (DWLOC), for chronic and acute exposures for all 
adults and children exceed the drinking water estimated concentrations 
(DWECs) from the models by many orders of magnitude. The acute DWLOC 
for children is 2,500 parts per billion (ppb). The acute DWEC is 0.098 
ppb. The chronic DWLOC for adults is 5,950 ppb. The chronic DWLOC for 
children/toddlers is 1,700 ppb. The DWEC for the worst case chronic 
scenario is 0.024 ppb. The drinking water levels of comparison are 
based on highly conservative dietary (food) exposures and are expected 
to be even higher in real world situations. Any exposure from 
triticonazole in drinking water would be negligible based on these 
highly conservative analyses.
    2. Non-dietary exposure. The pending CHIPCO brand TRITON 
registration for triticonazole is for commercial turf grass, golf 
courses and sod farms. It is not intended for home use. As such, there 
would be no exposure in residential homes from this use, and is not 
included in the aggregate risk assessment.

D. Cumulative Effects

     Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'', concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' There is no reliable data at this time 
to determine whether triticonazole has a common mechanism of toxicity 
with other substances, or how to include this pesticide in a cumulative 
risk assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
triticonazole does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance petition, 
therefore, it has not been assumed that triticonazole has a common 
mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. Using the conservative assumptions described 
above, based on the completeness and reliability of the toxicity data, 
it is concluded that chronic dietary exposure to the proposed uses of 
triticonazole will utilize less than 0.1% of the chronic reference dose 
for the U.S. population. The actual exposure is likely to be much less 
as more realistic data and models are developed. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or, below which daily aggregate exposure over a lifetime 
will not pose appreciable risk to human health. Acute exposure 
estimates for the U.S. population utilizes less than 0.1% of the acute 
RfD. This is a conservative assessment and actual exposure is likely to 
be far less. Drinking water levels of comparison based on the dietary 
exposure are much greater than highly conservative estimated levels, 
and would be expected to be well below the 100% level of the RfD, if 
they occur at all. Therefore, there is a reasonable certainty that no 
harm will occur to the U.S. population from aggregate exposure (food 
and drinking water) residues of triticonazole.
    2. Infants and children. FFDCA Section 408 provides that the Agency 
may apply an additional safety factor for infants and children to 
account for pre-natal and post-natal toxicity or incompleteness of the 
data base. The toxicology data base for triticonazole regarding 
potential pre-natal and post-natal effects in children is complete 
according to existing Agency data requirements and does not indicate 
any particular developmental or reproductive concerns. The 
developmental toxicity studies clearly demonstrate that triticonazole 
is not teratogenic and the reproductive toxicity study did not indicate 
any increased sensitivity to the effects of triticonazole in 
developing, or young animals. Therefore, an extra safety factor is not 
warranted.
     Using the conservative assumptions described in the exposure 
section above, exposure to residues of triticonazole in food for 
children 1-6 years old, (the most highly exposed sub group) is less 
than 0.1% of the acute and chronic reference doses. As in the adult 
situation, drinking water levels of comparison are much higher than the 
worst case drinking water estimated concentrations, and are expected to 
use well below 100% of the reference dose, if they occur at all. 
Therefore, there is a reasonable certainty that no harm will occur to 
infants and children from aggregate exposure to residues of 
triticonazole.

F. International Tolerances

     Maximum residue limits codex MRLs for triticonazole and 
metabolites in or on wheat and barley commodities have not been 
established by the Codex Alimentarius Commission.
[FR Doc. 02-6156 Filed 3-13-02; 8:45 am]
BILLING CODE 6560-50-S