[Federal Register Volume 70, Number 77 (Friday, April 22, 2005)]
[Rules and Regulations]
[Pages 20821-20831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-8123]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0388; FRL-7702-4]


Tetraconazole; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole in or on sugarbeet roots at 
0.05 parts per million (ppm), sugarbeet top at 3.0 ppm, sugarbeet dried 
pulp at 0.15 ppm, sugarbeet molasses at 0.15 ppm, meat of cattle, goat, 
horse, and sheep at 0.05 ppm, liver of cattle, goat, horse, and sheep 
at 4.0 ppm, fat of cattle, goat, horse, and sheep at 0.30 ppm, meat 
byproducts except liver of cattle, goat, horse and sheep at 0.10 ppm 
and milk at 0.05 ppm. Sipcam Agro USA, Inc. requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA). Registrations will be 
limited to the following States: Colorado, Minnesota, Michigan, 
Montana, North Dakota, Nebraska, and Wyoming where use has previously 
occurred under section 18 of FIFRA. The tolerances will expire on 
November 30, 2012.

DATES: This regulation is effective April 22, 2005. Objections and 
requests for hearings must be received on or before June 21, 2005.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under docket 
identification (ID) number OPP-2004-0388. All documents in the docket 
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although 
listed in the index, some information is not publicly available, i.e., 
CBI or other information whose disclosure is restricted by statute. 
Certain other material, such as copyrighted material, is not placed on 
the Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either electronically 
in EDOCKET or in hard copy at the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. 
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311),, e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be

[[Page 20822]]

affected by this action. Other types of entities not listed in this 
unit could also be affected. The North American Industrial 
Classification System (NAICS) codes have been provided to assist you 
and others in determining whether this action might apply to certain 
entities. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``FederalRegister'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of October 14, 1999 (64 FR 55714) (FRL-
6382-7), EPA issued a notice pursuant to section 408(d)(3) of the 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of three pesticide 
petitions (9F5066, 9F6023 and 7E4830) by Sipcam Agro, USA, Inc., 300 
Colonial Center Parkway, Roswell, GA 30076, formerly of 70 Mansell 
Court, Suite 230, Rosewell, GA 30076. The petitions requested that 40 
CFR part 180 be amended by establishing tolerances for residues of the 
fungicide tetraconazole, in or on the following raw agricultural 
commodities: beets, sugar at 0.01 ppm, beets, sugar, roots at 0.1 ppm, 
beets, sugar, tops at 7.0 ppm, beets, sugar, pulp, dried at 0.3 ppm, 
and beets, sugar, molasses at 0.3 ppm, cattle, meat at 0.01 ppm, cattle 
meat byproducts at 2.0 ppm, cattle fat at 0.1 ppm, and milk at 0.02 ppm 
(9F5066); peanuts meat (hulls removed) at 0.03 ppm, peanuts meal at 
0.03 ppm, and peanuts oil at 0.1 ppm (9F6023); and imported bananas at 
0.2 ppm (7E4830). Petition 7E4830 was later withdrawn. Petition 9F6023 
was placed in abeyance by the petitioner. There were no comments 
received in response to the notice of filing. The tolerances will 
expire on February 28, 2009.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances of November 26, 1997 (62 FR 62961) 
(FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of tetraconazole 1-
[2-(2,4-dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-
triazole in or on sugarbeet roots at 0.05 ppm; sugarbeet tops at 3.0 
ppm; sugarbeet dried pulp at 0.15 ppm; sugarbeet molasses at 0.15 ppm; 
meat of cattle, goat, horse, and sheep at 0.05 ppm; liver of cattle, 
goat, horse, and sheep at 4.0 ppm; fat of cattle, goat, horse, and 
sheep at 0.30 ppm; meat byproducts except liver of cattle, goat, horse 
and sheep at 0.10 ppm; and milk at 0.05 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by tetraconazole are 
discussed below. Table 1 of this unit presents the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.
    1. Acute toxicity. Acute toxicity data were as follows: Acute oral 
lethal dose (LD)50 = 1,031 milligrams/kilogram (mg/kg) 
(toxicity category III); acute dermal LD50 < 2,000 mg/kg 
(toxicity category III); acute inhalation lethal concentration 
(LC)50 = 3.66 mg/liter (L) (toxicity category IV); primary 
eye irritation - clear by 72 hours (toxicity category III); primary 
skin irritation - slight irritation (toxicity category IV); and dermal 
sensitization - negative.
    2. Developmental toxicity in rats. A developmental toxicity study 
was conducted using rats gavaged with doses of 0, 5, 22.5, 100 mg/kg/
day from days 2 through 15 of gestation. The maternal toxicity LOAEL is 
100 mg/kg/day based on decreased body weight gain, and food consumption 
and increased liver and kidney weights. The maternal toxicity NOAEL is 
22.5 mg/kg/day. Developmental toxicity was noted at 100 mg/kg/day and 
consisted of an increased incidence of small fetuses, and supernumerary 
ribs. The LOAEL and NOAEL for developmental toxicity were 100 and 22.5 
mg/kg/day, respectively.
    3. Development toxicity study in rabbits. A developmental toxicity 
study was conducted using rabbits gavaged with doses of 0, 7.5, 15, and 
30 mg/kg/day from days 6 through 18 of gestation. Compound-related 
maternal toxicity was limited to depressed body weight gain during the 
dosing period. No treatment-related effects occurred in maternal 
mortality, clinical signs, food consumption, or cesarean parameters. 
The maternal LOAEL is 30 mg/kg/day based on decreased body weight gain. 
The maternal NOAEL is 15 mg/kg/day. No treatment-related effects in 
developmental parameters were noted. The developmental LOAEL is greater 
than 30 mg/kg/day. The developmental NOAEL is 30 mg/kg/day, the highest 
dose tested (HDT).
    4. Two-generation reproduction study. A two-generation reproduction 
study was conducted using rats fed diets with dose levels of 0, 10, 70, 
or 490 ppm (0, 0.7, 4.9, and 35.5 mg/kg/day for males or 0, 0.8, 5.9, 
and 40.6 mg/kg/day for females). The LOAEL for parental toxicity was 70 
ppm (4.9 mg/kg/day in males and 5.9 mg/kg/day in females) based on 
increased mortality in P generation females. The NOAEL was 10 ppm (0.7 
mg/kg/day in males and 0.8 mg/kg/day in females). The LOAEL for 
offspring toxicity was 490 ppm (40.6

[[Page 20823]]

mg/kg/day from the P generation female intake) based on decreased 
litter weight and mean pup weight in litters of all generations before 
weaning and increased relative liver weights at weaning in both sexes 
of all litters. The NOAEL was 70 ppm (5.9 mg/kg/day). The LOAEL for 
reproductive toxicity was 70 ppm (4.9 mg/kg/day for males and 5.9 mg/
kg/day for females) based on increased mean gestation duration in P 
generation parental females and related evidence of compound toxicity 
in the parturition process. The NOAEL was 10 ppm (0.7 mg/kg/day for 
males and 0.8 for females).
    5. Chronic toxicity. A chronic toxicity study was conducted using 
dogs fed diets containing 0, 22.5, 90, or 360 ppm for 52 weeks. 
Treatment-related effects at the high dose included slight but 
nonsignificant body weight reductions in both sexes from study week 3 
to termination; significantly increased alkaline phosphatase, gamma-
glutamyltransferase, alanine aminotransferase and ornithine carbamoyl 
transferase in both sexes from study week 13 to 52, increased absolute 
and relative liver and kidney weights for both sexes, and 
histopathological changes in both organs. In the mid-dose group, 
effects were manifested as increased absolute and relative kidney 
weights for males correlated with histopathological findings in the 
males (apparent hypertrophy in cortical tubules of the kidneys in one 
male). No adverse effects were seen at the low dose. The NOAEL is 22.5 
ppm (equivalent to achieved intakes of 0.73 mg/kg/day for males or 0.82 
mg/kg/day for females) and the LOAEL is 90 ppm (equivalent to achieved 
intakes of 2.95 mg/kg/day for males or 3.33 mg/kg/day for females) 
based on increased absolute and relative kidney weights and 
histopathological changes in the male kidney.
    6. Carcinogenicity study--i. Rats. A 2-year carcinogenicity study 
was conducted using rats fed diets containing 0, 10, 80, 640 and 1,280 
ppm for males and 0, 10, 80, and 640 ppm for females. The LOAEL is 640 
ppm (27.7/39.4 mg/kg/day in male/female) based on histopathology of the 
bone (osseous hypertrophy of the cranium/parietal bone), pale and 
thickened incisors, and decreased absolute and relative adrenal and 
pituitary weights in males; decreased body weight (at terminal 
sacrifice) in females. The NOAEL is 80 ppm (3.4/4.4 mg/kg/day in male/
female). Under the conditions of this study, there was no evidence of a 
treatment-related increase in tumor incidence when compared to 
controls. Therefore, tetraconazole is not a carcinogen in this study.
    ii. Mice. An 80-week carcinogenicity study was conducted using mice 
fed diets containing 0, 10, 90, 800, or 1,250 ppm (0, 1.4, 12, 118, or 
217 mg/kg/day for males; 0, 1.6, 14.8, 140, or 224 mg/kg/day for 
females). The systemic toxicity LOAEL is 90 ppm (12 and 14.8 mg/kg/day 
for males and females, respectively), based on increased liver weight 
and hepatocyte vacuolation in both sexes and increased kidney weights 
in males. The NOAEL is 10 ppm (1.4 and 1.6 mg/kg/day for males and 
females, respectively). There was evidence of increased incidence of 
combined benign and malignant liver tumors in mice of both sexes 
treated with 95.05% tetraconazole at 800 ppm (48% for males and 22% for 
females) and 1,250 ppm (84% for males and 64% for females) compared to 
the control (20% for males and 0% for females). The doses were found to 
be adequate to test the carcinogenic potential based on the reduction 
of body weight gain and increased mortality at the highest dose.
    7. Mutagenicity studies. A battery of mutagenicity studies yielded 
negative results in Salmonella typhimurium, cultured Chinese hamster 
ovary (CHO) cells, and mouse lymphoma cells. There was no evidence of 
clastogenicity in vitro or in vivo and tetraconazole did not induce 
unscheduled DNA synthesis in human HeLa cells.

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the LOAEL is sometimes 
used for risk assessment if no NOAEL was achieved in the toxicology 
study selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor is retained due to 
concerns unique to the FQPA, this additional factor is applied to the 
RfD by dividing the RfD by such additional factor. The acute or chronic 
population adjusted dose (aPAD or cPAD) is a modification of the RfD to 
accommodate this type of FQPA Safety Factor (SF).
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-6 or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for tetraconazole used for human risk assessment is shown in 
the following Table 1.

[[Page 20824]]



    Table 1.--Summary of Toxicological Dose and Endpoints for Tetraconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                  FQPA SF* and Special
          Exposure Scenario               Dose Used in Risk       Level of Concern for   Study and Toxicological
                                            Assessment UF           Risk Assessment              Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       Not established          None                     An end-point of concern
 (Infants and Children)                                                                   attributable to a
                                                                                          single dose was not
                                                                                          identified
                                                                                         An acute RfD was not
                                                                                          established
----------------------------------------------------------------------------------------------------------------
Acute dietary, females (13- 50 years   NOAEL = 22.5 mg/kg/day   FQPA SF = 1X             Oral developmental
 of age)                               UF = 100...............  aPAD = acute RfD / FQPA   toxicity study - rat
                                       Acute RfD = 0.225 mg/kg   SF = 0.225 mg/kg.       Developmental NOAEL =
                                                                                          22.5 mg/kg/day, based
                                                                                          on increased incidence
                                                                                          of small fetuses, and
                                                                                          supernumerary ribs
----------------------------------------------------------------------------------------------------------------
Chronic dietary, all populations       NOAEL = 0.73 mg/kg/day   FQPA SF = 1X             Chronic oral toxicity -
                                       UF = 100...............  cPAD = chronic RfD /      dog
                                       Chronic RfD = 0.0073 mg/  FQPA SF = 0.0073 mg/kg/ Systemic toxicity LOAEL
                                        kg/day.                  day.                     = 2.95/3.33 (M/F) mg/
                                                                                          kg/day, based on
                                                                                          absolute and relative
                                                                                          kidney weights and
                                                                                          histopathological
                                                                                          changes in the male
                                                                                          kidney
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      ``likely to be                                    Q1 * = 2.30 x 10-2,
                                        carcinogenic to                                   based on male mouse
                                        humans''                                          liver benign and/or
                                                                                          malignant combined
                                                                                          tumor rates
----------------------------------------------------------------------------------------------------------------
* The reference to the FQPA SF refers to any additional safety factor retained due to concerns unique to the
  FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Section 18 tolerances 
have been established (40 CFR 180.557) for the residues of 
tetraconazole, in or on the following raw agricultural commodities: 
Sugarbeet roots, tops, molasses and dried pulp and cattle meat, meat 
byproducts and milk. The tolerances proposed in this assessment are 
numerically different from the current section 18 tolerance levels 
which were based on higher use rates. Additionally, tolerances are 
being proposed for goat, horse, and sheep commodities in addition to 
cattle. Since section 18 registrations have been authorized for the use 
of tetraconazole on soybeans to control soybean rust, this dietary 
assessment for use of tetraconazole on sugarbeets assumes residues on 
soybean products as well as poultry and swine commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
tetraconazole in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure. The Dietary Exposure Evaluation Model 
(DEEMTM-FCIDTM) analysis evaluated the individual 
food consumption as reported by respondents in the United States 
Department of Agriculture (USDA)1994-1996 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII) and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the acute exposure assessments: Tolerance level residues were used for 
all commodities and it was assumed that 100% of all crops were treated.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the DEEMTM-FCIDTM analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1994-1996 Nationwide CSFII and accumulated exposure to the chemical for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: Tolerance level residues were assumed for all 
soybean commodities, poultry liver, poultry meat byproducts, and eggs. 
Anticipated residues were assumed for poultry fat, poultry meat, milk, 
and all sugarbeet, goat, horse, sheep, cattle, and swine commodities. 
It was assumed that 100% of all crops were treated.
    iii. Cancer. In conducting the cancer dietary risk assessment the 
Dietary Exposure Evaluation Model (DEEMTM-FCIDTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 CSFII and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the cancer exposure assessments: Tolerance level residues were assumed 
for poultry liver, poultry meat byproducts, and eggs. Anticipated 
residues were assumed for poultry fat, poultry meat, milk, and all 
soybean, sugarbeet, cattle, goat, sheep, horse and swine commodities. 
For sugarbeets, 52 percent crop treated (PCT) was assumed and 67 PCT 
was assumed for soybeans. Additionally, water was included as a dietary 
commodity with a tetraconazole concentration of 0.00446 ppm, equal to 
the 30-year average surface water concentration.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of the FFDCA authorizes EPA to use available data and information on 
the anticipated residue levels of pesticide residues in food and the 
actual levels of pesticide chemicals that have been measured in food. 
If EPA relies on such information, EPA must require that data be 
provided 5 years after the tolerance is established, modified, or left 
in effect, demonstrating that the levels in food are not above the 
levels anticipated. Following the initial data submission, EPA is 
authorized to require similar data on a time frame it deems 
appropriate. As required by section 408(b)(2)(E) of the FFDCA, EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use 
data on the actual percent of food treated for assessing chronic 
dietary risk only if the Agency can make the following findings: 
Condition 1, that the data used are reliable and provide a valid basis 
to show what percentage of the food derived from such crop is likely to 
contain such pesticide residue; Condition 2, that the exposure estimate 
does not underestimate exposure for any significant subpopulation 
group; and Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the

[[Page 20825]]

Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
under section 408(b)(2)(F) of the FFDCA, EPA may require registrants to 
submit data on PCT.
    The Agency used PCT information as follows:
    The cancer dietary exposure analysis used 52 PCT for sugarbeets and 
67 PCT for soybeans. The sugarbeet 52 PCT was based on information from 
the United States Department of Agriculture (USDA) and from a 
propietary source used by the Agency. The soybean 67 PCT was taken from 
the maximum acreage per state allowed on Section 18 applications for 
tetraconizole on soybeans; the maximum acreages for the 28 States with 
these Section 18 applications were added together and divided by an 
estimate of the total number of acres where soybeans would be grown in 
the United States.
    The Agency believes that the three conditions listed in Unit 
C.1.iv. have been met. With respect to Condition 1, PCT estimates are 
derived from Federal and private market survey data which are reliable 
and have a valid basis.For acute dietary exposure estimates, EPA uses 
an estimated maximum PCT. The exposure estimates resulting from this 
approach reasonably represent the highest levels to which an individual 
could be exposed, and are unlikely to underestimate an individual's 
acute dietary exposure. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which tetraconazole 
may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for tetraconazole in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of tetraconazole.
    The Agency uses the First Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), 
to produce estimates of pesticide concentrations in an index reservoir. 
The SCI-GROW (screenimg concentration in ground water) model is used to 
predict pesticide concentrations in shallow ground water. For a 
screening-level assessment for surface water EPA will use FIRST (a Tier 
1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a 
subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an 
index reservoir environment, the PRZM/EXAMS model includes a percent 
crop (PC) area factor as an adjustment to account for the maximum PC 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to tetraconazole they are 
further discussed in the aggregate risk sections in Unit III. E.
    Based on the PRZM 3.12/ EXAMS 2.7.97 model, the estimated EECs of 
tetraconazole for acute exposures are estimated to be 8.38 parts per 
billion (ppb) for surface water, representing the 1 in 10 year annual 
peak concentrations. The surface water EECs are estimated to be 5.58 
ppb for chronic non-cancer exposures (the 1 in 10 year annual average 
concentration) and 4.46 ppb for chronic cancer exposures (the 30 year 
annual average concentration).
    Based on the SCI-GROW model the ground water EECs for all exposures 
are estimated to be 0.5 ppb.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Tetraconazole is not 
registered for use on any sites that would result in residential 
exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to tetraconazole and any 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that tetraconazole has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the policy 
statements released by EPA's Office of Pesticide Programs concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's website at 
http://www.epa.gov/pesticides/cumulative/.
    However, the Agency does have concern about potential toxicity to 
1,2,4-triazole and two conjugates, triazolylalanine and triazolyl 
acetic acid, metabolites common to most of the triazole fungicides. To 
support the extension of existing parent triazole-derivative fungicide 
tolerances, EPA conducted an interim human health assessment for 
aggregate exposure to 1,2,4-triazole. The exposure and risk estimates 
presented in this assessment are overestimates of actual likely 
exposures and therefore, should be considered to be highly 
conservative.

[[Page 20826]]

Based on this assessment EPA concluded that for all exposure durations 
and population subgroups, aggregate exposures to 1,2,4-triazole are not 
expected to exceed its level of concern. This assessment should be 
considered interim due to the ongoing series of studies being conducted 
by the U.S. Triazole Task Force (USTTF). Those studies are designed to 
provide the Agency with more complete toxicological and residue 
information for free triazole. Upon completion of the review of these 
data, EPA will prepare a more sophisticated assessment based on the 
revised toxicological and exposure databases.
    i. Toxicology. The toxicological database for 1,2,4-triazole is 
incomplete. Preliminary summary data presented by the USTTF to EPA 
indicate that the most conservative endpoint currently available for 
use in a risk assessment for 1,2,4-triazole is a LOAEL of 15 mg/kg/day, 
based on body weight decreases in male rats in the reproductive 
toxicity study (currently underway). This endpoint, with an uncertainty 
factor of 1,000 was used for both acute and chronic dietary risk, 
resulting in an RfD of 0.015 mg/kg/day. The uncertainty factor of 1,000 
includes an additional 10X safety factor for the protection of infants 
and children. The resulting PAD is 0.015 mg/kg/day.
    ii. Dietary exposure. The USTTF conducted an acute dietary exposure 
assessment based on the highest triazole-derivative fungicide tolerance 
level combined with worst-case molecular weight and plant/livestock 
metabolic conversion factors. This approach provides a conservative 
estimate of all sources for 1,2,4-triazole except the in vivo 
conversion of parent compounds to free-triazole following dietary 
exposure. The degree of animal in vivo conversion is dependent on the 
identity of the parent fungicide. In rats, this conversion ranges from 
0 to 77%--the in vivo conversion for tetraconazole is 77%. For purposes 
of this interim assessment, EPA used the dietary exposure estimates 
provided by the USTTF adjusted based on the highest rate of conversion 
observed for any of the parent triazole-derivative fungicides to 
account for this metabolic conversion. The assessment includes residue 
estimates for all food commodities with either existing or pending 
triazole-derivative fungicide registrations. The resulting acute 
dietary exposure estimates are extremely conservative and range from 
0.0032 mg/kg/day for males 20+ years old to 0.014 mg/kg/day for 
children 1 to 6 years old. Estimated risks range from 22 to 93% of the 
PAD. In order to estimate chronic exposures via food, EPA used the 
70th percentile of exposures from the acute assessment. The 
70th percentile is a common statistic used to estimate 
central tendency from a distribution and its use to estimate chronic 
exposures is appropriate. Estimated risks range from 10 to 47% of the 
PAD. The dietary assessment does not include potential exposure via 
residues in water. It is emphasized that the use of both highest-
tolerance-level residues and the highest in vivo conversion factor 
results in dietary risk estimates that far exceed the likely actual 
risk.
    iii. Non-dietary exposure. Triazole-derivative fungicides are 
registered for use on turf, resulting in the potential for residues of 
free triazole in grass and/or soil. Thus, dermal and incidental oral 
exposures to children may occur. It is believed that residues of free 
triazole occur within the plant matrices and are not available as 
surface residues. Therefore, direct dermal exposure to 1,2,4-triazole 
due to contact with plants is not likely to occur. However, dermal 
exposure to parent fungicide and subsequent in vivo conversion to 
1,2,4-triazole may occur. In order to account for this indirect 
exposure to free triazole, EPA used a conversion factor of 10%, which 
is the highest rate of in-vivo conversion observed in rats for any of 
the triazole-derivative fungicides with registrations on turf. 
Incidental oral exposure may occur by direct and indirect routes. To 
assess direct exposure, EPA used a conversion factor of 17%, which is 
the highest rate of conversion to free triazole observed in any of the 
plant metabolism studies. As with indirect dermal exposure, EPA used a 
conversion factor of 10% in its assessment of indirect oral exposure.
    Based on residential exposure values estimated for propiconazole 
(0.0005 mg/kg/day via the dermal route and 0.03 mg/kg/day via the oral 
route) and the conversion factors described above, combined direct and 
indirect dermal exposures are estimated to be less than 0.0001 mg/kg/
day and combined oral exposures are estimated to be less than 0.0019 
mg/kg/day. The overall residential exposure is likely to be less than 
0.0020 mg/kg/day. Relative to the 15 mg/kg/day point of departure, this 
gives an MOE of approximately 7,500 for children. Based on the current 
set of uncertainty factors, the target MOE is 1,000, indicating that 
the risk associated with residential exposure to 1,2,4-triazole for 
children is below EPA's level of concern. The adult dermal exposure 
estimate is slightly less than that of children. Incidental oral 
exposure is not expected to occur with adults.
    iv. Drinking water. Modeled estimates of 1,2,4-triazole residues in 
surface and ground water, as reported by the USTTF, and the DWLOC 
approach were used to address exposure to free triazole in drinking 
water. Estimated environmental concentrations (EECs) of free triazole 
in ground water were obtained from the SCI-GROW model and range from 
0.0 to 0.026 ppb, with the higher concentrations associated with uses 
on turf. Surface water EECs were obtained using the FIRST model. Acute 
surface water EECs ranged from 0.29 to 4.64 ppb for agricultural uses 
and up to 32.1 ppb from use on golf course turf. EPA notes that ground 
water monitoring studies in New Jersey and California showed maximum 
residues of 16.7 and 0.46 ppb, respectively, which exceed the SCI-GROW 
estimates significantly. Contrarily, preliminary monitoring data from 
USDA's Pesticide Data Program for 2004 show no detectable residues of 
1,2,4-triazole in any drinking water samples, either treated or 
untreated (maximum limit of detection (LOD) = 0.73 ppb, n=40 each).
    v. Aggregate exposure. In estimating aggregate exposure, EPA 
combined potential dietary and non-dietary sources of 1,2,4-triazole. 
To account for the drinking water component of dietary exposure, EPA 
used the DWLOC approach, as noted above. The DWLOC represents a maximum 
concentration of a chemical in drinking water at or below which 
aggregate exposure will not exceed EPA's level of concern. In 
considering non-dietary exposure, EPA used the residential exposure 
estimate for children and applied it to all population subgroups. As 
previously noted, this estimate is considered to be highly conservative 
for children. Since adults are not expected to have non-dietary oral 
exposure to 1,2,4-triazole and that pathway makes up the majority of 
the residential exposure estimate for children, application of that 
exposure estimate to adults is considered to be extremely conservative. 
Residential exposure is expected to occur for short-term and/or 
intermediate-term durations, and therefore, is not a component in the 
acute or chronic aggregate exposure assessment. In order to assess 
aggregate short-term and intermediate-term exposure, EPA combined the 
residential exposure estimate and the background level of exposure to 
free triazole via food. Less than 1% of lawns in the United States are 
expected to be treated with triazole fungicides, so the likelihood of 
co-occurring dietary and residential exposures is very low.
    With the exception of the acute DWLOCs for infants and children 1 
to

[[Page 20827]]

6 years old, all DWLOCs are greater than the largest EEC (surface water 
estimate from use on turf). The EEC's for these two population groups 
exceed the DWLOC's by 1.1 to 3.2-fold, a result typically interpreted 
to mean that aggregate exposure exceeds EPA's level of concern. 
Although comparing the EEC's and the acute DWLOCs for infants and 
children 1 to 6 years old indicate that aggregate exposure may exceed 
the aPAD of 0.015 mg/kg/day, EPA does not believe this to be the case 
due to the extremely conservative nature of the overall assessment 
(highest-tolerance level residues, 100% crop treated (CT), 77% in vivo 
conversion factor). Furthermore, the drinking water monitoring data 
from the Pesticide Data Program found no detectable residues of either 
free triazole or parent triazole - derivative fungicide in its 
preliminary 2004 dataset, indicating that neither parent compounds nor 
1,2,4-triazole are likely to occur in drinking water. For all exposure 
durations and population subgroups, EPA does not expect aggregate 
exposures to 1,2,4-triazole to exceed its level of concern.
    The Agency is planning to conduct a more sophisticated human health 
assessment in 2005 following submission and review of the ongoing 
toxicology and residue chemistry studies for 1,2,4-triazole.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA 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 on toxicity and exposure 
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 MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. In applying this provision, 
EPA either retains the default value of 10X when reliable data do not 
support the choice of a different factor, or, if reliable data are 
available, EPA uses a different additional safety factor value based on 
the use of traditional uncertainty factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
to tetraconazole. In the developmental toxicity study in rats, 
developmental effects were seen at the same dose that induced maternal 
toxicity. In the developmental toxicity study in rabbits, no 
developmental toxicity was seen at the HDT. In the two-generation 
reproduction study, offspring toxicity occurred at doses higher than 
the dose that induced parental/systemic toxicity. There are no concerns 
or residual uncertainties for prenatal and/or postnatal toxicity. 
Additionally, there is no concern for neurotoxicity resulting from 
exposure to tetraconazole since there was no evidence of neurotoxicity 
in short-term studies in rats, mice and dogs; and a long-term toxicity 
study in dogs.
    3. Conclusion. Based on the following, EPA concluded that the 
additional safety factor for the protections of infants and children 
could be removed:
     There is no quantitative or qualitative evidence of 
increased susceptibility of rat and rabbit fetuses to in utero exposure 
in developmental studies.
     There is no quantitative or qualitative evidence of 
increased susceptibility of rat offspring in the multi-generation 
reproduction study.
     There are no residual uncertainties for prenatal/postnatal 
toxicity.
     The toxicological database is complete for FQPA 
assessment.
     The chronic non-cancer dietary food exposure assessment 
utilizes anticipated residue data and assumed 100% CT.
     The chronic assessment will not underestimate exposure or 
risk since the refinement is based on reliable data derived from 
studies designed to produce worst-case residues.
     At this time, only agricultural uses have been proposed 
for tetraconazole. There are no uses that would result in residential 
or recreational exposures.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the U.S. EPA Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food to 
tetraconazole will occupy 0.5% of the aPAD for females 13 to 49 years 
old, the only population subgroup for which an acute toxicity endpoint 
was determined. In addition, there is potential for acute dietary 
exposure to tetraconazole in drinking water. After calculating DWLOCs 
and comparing them to the EECs for surface water and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the aPAD, as 
shown in the following Table 2.

[[Page 20828]]



                                        Table 2.--Aggregate Risk Assessment for Acute Exposure to Tetraconazole.
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC
                   Population Subgroup                      aPAD (mg/kg/day)    % aPAD (Food)          (ppb)              (ppb)        Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                              0.225                0.5               8.38               0.51              6,720
--------------------------------------------------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
tetraconazole from food will utilize 3.9% of the cPAD for the U.S. 
population, 11.1% of the cPAD for non-nursing infants and 8.9% of the 
cPAD for all infants < 1 year old. There are no residential uses for 
tetraconazole that result in chronic residential exposure to 
tetraconazole. In addition, there is potential for chronic dietary 
exposure to tetraconazole in drinking water. After calculating DWLOCs 
and comparing them to the EECs for surface water and ground water, EPA 
does not expect the aggregate exposure to exceed 100% of the cPAD, as 
shown in following Table 3.

                                 Table 3.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Tetraconazole.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC    Chronic DWLOC
                   Population Subgroup                       cPAD mg/kg/day      %cPAD (Food)          (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                       0.0073                3.9               5.58               0.51                246
--------------------------------------------------------------------------------------------------------------------
All infants (< 1 year old)                                            0.0073                8.9               5.58               0.51                 67
--------------------------------------------------------------------------------------------------------------------
Non-nursing infants                                                   0.0073               11.1               5.58               0.51                 65
--------------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                              0.0073                8.4               5.58               0.51                 67
--------------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                                              0.0073                8.5               5.58               0.51                 67
--------------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                                             0.0073                6.1               5.58               0.51                 69
--------------------------------------------------------------------------------------------------------------------
Youth (13-19 years old)                                               0.0073                4.0               5.58               0.51                210
--------------------------------------------------------------------------------------------------------------------
Adults (20-49)                                                        0.0073                3.1               5.58               0.51                248
--------------------------------------------------------------------------------------------------------------------
Adults (50+ years old)                                                0.0073                2.5               5.58               0.51                249
--------------------------------------------------------------------------------------------------------------------
Females (13-49 years old)                                             0.0073                3.0               5.58               0.51                210
--------------------------------------------------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Tetraconazole is not 
registered for use on any sites that would result in residential 
exposure. Therefore, the aggregate risk is the sum of the risk from 
food and water. The risk does not exceed the Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Tetraconazole is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water. The risk does not exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. The estimated cancer 
risk for the proposed use on sugarbeets and existing section 18 
exemptions for soybeans is 2.5 x 10-6, a value that falls 
within the Agency's risk standard for cancer in the range of 1 x 
10-6.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to tetraconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromotography with 
electron capture detector (GC/ECD)) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: [email protected].

B. International Residue Limits

    There are no established Codex, Canadian, or Mexican Maximum 
Residue Limits (MRLs) established for tetraconazole.

C. Conditions

    The following conditions will be applied to the registration of 
tetraconazole for use on sugarbeets:
    1. Registration and tolerances will be time-limited to allow review 
of triazole data and completion of the triazole risk assessment.
    2. Registrations will be limited to the following States: Colorado, 
Minnesota, Michigan, Montana, North Dakota, Nebraska, and Wyoming where 
use has previously occurred under section 18 of FIFRA.
    3. The registrant will be required to provide one additional side-
by-side sugarbeet field trial comparing two and six applications of 
Eminent 125SL at 0.10 lb ai/acre/application.
    4. The registrant will be required to provide a 28 day inhalation 
study.
    5. Well documented estimates of how many pounds of tetraconazole 
will be placed on the market to treat sugarbeets.

[[Page 20829]]

    6. Tetraconazole use reporting on sugarbeets. This information 
should be reported as how many pounds of tetraconazole will be applied 
per acre on sugarbeets.

V. Conclusion

    Therefore, the tolerances are established for residues of 
tetraconazole, 1-[2-(2,4-dichlorophenyl)-3-(1,1,2,2-
tetrafluoroethoxy)propyl]-1H-1,2,4-triazole in or on sugarbeet root at 
0.05 ppm, sugarbeet top at 3.0 ppm, sugarbeet dried pulp at 0.15 ppm, 
sugarbeet molasses at 0.15 ppm, meat of cattle, goat, horse, and sheep 
at 0.05 ppm, liver of cattle, goat, horse, and sheep at 4.0 ppm, fat of 
cattle, goat, horse, and sheep at 0.30 ppm, meat byproducts except 
liver of cattle, goat, horse and sheep at 0.10 ppm and milk at 0.05 
ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. EPA procedural regulations 
which govern the submission of objections and requests for hearings 
appear in 40 CFR part 178. Although the procedures in those regulations 
require some modification to reflect the amendments made to the FFDCA 
by the FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d), 
as was provided in the old sections 408 and 409 of the FFDCA. However, 
the period for filing objections is now 60-days, rather than 30-days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2004-0388 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before June 21, 
2005.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0388, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various

[[Page 20830]]

levels of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive Order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of the FFDCA. For these same reasons, 
the Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive Order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct effects on tribal governments, on the relationship between the 
Federal Government and Indian tribes, or on the distribution of power 
and responsibilities between the Federal Government and Indian tribes, 
as specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 14, 2005.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.557 is revised to read as follows:


Sec.  180.557  Tetraconazole; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of the fungicide, tetraconazole 1-[2-(2,4-
dichlorophenyl)-3-(1,1,2,2-tetrafluoroethoxy)propyl]-1H-1,2,4-triazole 
in or on the following commodities:

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/revocation
                           Commodity                               Parts per million               date
----------------------------------------------------------------------------------------------------------------
Beet, sugar, dried pulp.......................................                     0.15                 11/30/12
Beet, sugar, molasses.........................................                     0.15                 11/30/12
Beet, sugar, roots............................................                     0.05                 11/30/12
Beet, sugar, tops.............................................                      3.0                 11/30/12
Cattle, fat...................................................                     0.30                 11/30/12
Cattle, liver.................................................                      4.0                 11/30/12
Cattle, meat..................................................                     0.05                 11/30/12
Cattle, meat byproducts, except liver.........................                     0.10                 11/30/12
Goat, fat.....................................................                     0.30                 11/30/12
Goat, liver...................................................                      4.0                 11/30/12
Goat, meat....................................................                     0.05                 11/30/12
Goat, meat byproducts, except liver...........................                     0.10                 11/30/12
Horse, fat....................................................                     0.30                 11/30/12
Horse, liver..................................................                      4.0                 11/30/12
Horse, meat...................................................                     0.05                 11/30/12
Horse, meat byproducts, except liver..........................                     0.10                 11/30/12
Milk..........................................................                     0.05                 11/30/12
Sheep, fat....................................................                     0.30                 11/30/12
Sheep, liver..................................................                      4.0                 11/30/12
Sheep, meat...................................................                     0.05                 11/30/12
Sheep, meat byproducts, except liver..........................                     0.10                 11/30/12
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[[Page 20831]]

    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 05-8123 Filed 4-21-05; 8:45 am]
BILLING CODE 6560-50-S