[Federal Register Volume 72, Number 69 (Wednesday, April 11, 2007)]
[Rules and Regulations]
[Pages 18128-18134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6837]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0576; FRL-8121-3]


Tetraconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tetraconazole in or on peanut, pecan, sugarbeet and soybean. Sipcam 
Agro USA, Inc. and Isagro S.p.A. requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 11, 2007. Objections and 
requests for hearings must be received on or before June 11, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-

[[Page 18129]]

OPP-2006-0576. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. All 
documents in the docket are listed in the docket index available in 
regulations.gov. Although listed in the index, some information is not 
publicly available, e.g., Confidential Business Information (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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 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: Lisa Jones, Fungicide Branch, 
Registration Division, Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9424; 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 those 
engaged in the following activities:
     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 to 
provide a guide for readers regarding entities likely to be 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?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot CFR site 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0576 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 as required by 40 CFR part 178 on or 
before June 11, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2006-0576, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of July 26, 2006 (71 FR 42392) (FRL-8074-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F6971) by Isagro S.p.A., 430 Davis Dr., Suite 240, Morrisville, NC 
27560. The petition requested that 40 CFR 180.557 be amended by 
establishing a tolerance 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 soybean, seed at 0.1 parts per million (ppm), 
soybean, aspirated grain fractions/soybean, refined oil at 0.5 ppm, 
poultry, fat at 0.05 ppm, and poultry, egg/liver/meat/meat byproducts 
at 0.01 ppm. That notice referenced a summary of the petition prepared 
by Isagro S.p.A., the registrant, which is available to the public in 
the docket, http://www.regulations.gov. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C. below.
    In the Federal Register of December 20, 2006 (71 FR 76321) (FRL-
8104-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
6F7084, 9F6023, 9F5066) by Sipcam Agro USA, Inc., Colonial Center 
Parkway,  230, Roswell, GA 30076. Petition 6F7084 requested 
that 40 CFR 180.557 be amended by establishing tolerances for residues 
of the fungicide tetraconazole in or on pecan at 0.05 ppm. Petition 
9F6023 requested that 40 CFR 180.557 be amended by establishing 
tolerances for residues of the fungicide tetraconazole in or on the 
food commodities peanut, nutmeat at 0.05 ppm, and peanut, refined oil 
at 0.15 ppm. Petition 9F5066 requested that 40 CFR 180.557 be amended 
by revising the existing tolerances for residues of the fungicide 
tetraconazole in or on sugarbeet roots at 0.05 ppm, sugarbeet top at 
3.0 ppm, sugarbeet dried pulp at

[[Page 18130]]

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. That notice referenced a summary of the petition prepared by 
Sipcam Agro USA, Inc., the registrant, which is available to the public 
in the docket, http://www.regulations.gov. There were no comments 
received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    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. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in section 408(b)(2)(D), 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 for the petitioned-for tolerances 
for residues of tetraconazole. 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. Specific information on the studies received and the nature 
of the adverse effects caused by as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of April 22, 2005 (70 FR 20821), 
(FRL-7702-4).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable uncertainty/safety factors. Short-, intermediate, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the margin of exposure (MOE) called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for tetraconazole used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 22, 2005 (70 FR 20821) (FRL-
7702-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to, EPA considered exposure under the petitioned-for 
tolerances as well as all existing tolerances in (40 CFR 180.557). EPA 
assessed dietary exposures from tetraconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure. An acute endpoint was not 
identified for the general population. In estimating acute dietary 
exposure for females aged 13 to 49, EPA used food consumption 
information from the USDA 1994-1996 and 1998 Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA assumed that all food and feed commodities with established 
and proposed tolerances contain tolerance-level residues and that 100% 
of crops were treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide CSFII. As to residue levels in food, EPA relied 
upon empirical processing factors, average field trial residues for all 
crops and average residues in meat and meat by-products derived from 
feeding studies. Percent crop treated information was not used.
    iii. Cancer. In conducting the cancer dietary risk assessment, EPA 
used the food consumption data from the USDA 1994-1996 and 1998 CSFII. 
The refined dietary cancer risk assessment used empirical processing 
factors, average field trial residues for all crops, average residues 
in meat and meat by-products derived from feeding studies and projected 
percent crop treated estimates for peanuts, soybean and sugarbeets.
    iv. Anticipated residue and percent crop treated (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 residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to section 408(f)(1) 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. For the 
present action, EPA will issue such Data Call-Ins as are required by 
FFDCA section 408(b)(2)(E) and authorized under FFDCA section 
408(f)(1). Data will be required to be submitted no later than 5 years 
from the date of issuance of this tolerance.

[[Page 18131]]

    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    a. 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;
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group; and
    c. 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 Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    EPA estimates projected percent crop treated (PPCT) for a new 
pesticide use by initially assuming that the percent crop treated (PCT) 
during the pesticide's initial 5 years of use on a specific use site 
will not exceed the average PCT of the market leader (i.e., the one 
with the greatest PCT) on that site. EPA also examines all other 
available data to determine if this method of projecting percent crop 
treated produces a reliable estimate.
    The Agency used PPCT information for the cancer dietary exposure 
assessment as follows: Peanuts - 77%; sugar beets - 70%; and soybeans - 
27%.
    The PPCT for peanuts was determined by averaging the PCTs of the 
leading fungicide, in this case, chlorothalonil, for the three most 
recent available years (1991, 1999 and 2004). These data show 77% PPCT 
based on average market leader values.
    The PPCT for sugar beets was determined as the PCT of the leading 
fungicide, in this case, tetraconazole itself, for the year 2000, based 
on its use on sugar beets following registration under Section 18 of 
FIFRA for use in seven states (Colorado, Michigan, Minnesota, Montana, 
Nebraska, North Dakota, and Wyoming). Tetraconazole is the current 
market leader (55%) in those seven states where it is currently used. 
However, the acreage potentially treated by tetraconazole rises by 18% 
when four other sugarbeet growing states (California, Idaho, Oregon and 
Washington) are also considered. Treating all the planted acreage in 
these four additional states with tetraconazole could bring the PPCT up 
to 70%.
    The PPCT for soybeans was determined using a modified approach. Due 
to the discovery of a new and important disease on soybeans (Asian 
soybean rust), historical information was not considered useful for 
estimating PCT for soybeans. PCT estimates were obtained for future 
market leaders from soybean crop specialists. For a conservative 
estimate EPA utilized only the maximum projected values provided by 
each respondent, which ranged from 15 to 38%. These values translated 
into average and maximum PPCT values of 27 and 38%, respectively. EPA's 
evaluation of the basis for these estimates and other factors bearing 
on the potential use of tetraconazole show that it is unlikely that 
these estimates will be exceeded.
    The Agency believes that the three conditions listed in the second 
paragraph of Unit III.C.1.iv have been met. With respect to Condition 
1, the data relied upon is discussed above. Where EPA relies on PCT 
data on existing uses, EPA typically uses the United States Department 
of Agriculture, National Agricultural Statistical Service (USDA/NASS) 
as the primary source for PCT data. When a specific use site is not 
surveyed by USDA/NASS, EPA uses other sources including proprietary 
data and calculates the PCT. Comparisons are only made among pesticides 
of the same pesticide types (i.e., the leading fungicide on the use 
site is selected for comparison with the new fungicide). The PCTs 
included in the average may be for the same pesticide, or for different 
pesticides, since the same, or different pesticides, may dominate for 
each year selected. 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 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 environmental 
fate characteristics of tetraconazole. Further information regarding 
EPA drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) for 
acute exposures are estimated to be 20.01 parts per billion (ppb) for 
surface water. The EECs for chronic exposures are estimated to be a 
yearly average of 7.26 ppb for surface water and 1.79 ppb for ground 
water and a 30-year annual average of 4.97 for surface water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 20.01 ppb was used to 
access the contribution to drinking water. For chronic and cancer 
dietary risk assessment, the water concentration of value 4.97 ppb was 
used to access the contribution to drinking water.
    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.''
    Tetraconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same,

[[Page 18132]]

or essentially the same, sequence of major biochemical events (EPA, 
2002). In conazoles, however, a variable pattern of toxicological 
responses is found. Some are hepatotoxic and hepatocarcinogenic in 
mice. Some induce thyroid tumors in rats. Some induce developmental, 
reproductive, and neurological effects in rodents. Furthermore, the 
conazoles produce a diverse range of biochemical events including 
altered cholesterol levels, stress responses, and altered DNA 
methylation. It is not clearly understood whether these biochemical 
events are directly connected to their toxicological outcomes. Thus, 
there is currently no evidence to indicate that conazoles share common 
mechanisms of toxicity and EPA is not following a cumulative risk 
approach based on a common mechanism of toxicity for the conazoles. For 
information regarding EPA's procedures for cumulating effects from 
substances found to have a common mechanism of toxicity, see EPA's 
website at http://www.epa.gov/pesticides/cumulative.
    Triazole-derived pesticides can form the common metabolite 1,2,4-
triazole and two triazole conjugates (triazolylalanine and 
triazolylacetic acid). To support existing tolerances and to establish 
new tolerances for triazole-derivative pesticides, including 
tetraconazole, EPA conducted a human health risk assessment for 
exposure to 1,2,4-triazole, triazolylalanine and triazolylacetic acid 
resulting from the use of all current and pending uses of any triazole-
derived fungicide as of September 1, 2005. The risk assessment is a 
highly conservative, screening-level evaluation in terms of hazards 
associated with common metabolites (e.g., use of a maximum combination 
of uncertainty factors) and potential dietary and non-dietary exposures 
(i.e., high end estimates of both dietary and non-dietary exposures). 
In addition, the Agency retained the additional 10X FQPA safety factor 
for the protection of infants and children. The assessment includes 
evaluations of risks for various subgroups, including those comprised 
of infants and children. The Agency's complete risk assessment is found 
in the propiconazole reregistration docket at http://www.regulations.gov, Docket Identification (ID) Number EPA-HQ-OPP-2005-
0497.
    For tetraconazole, the new use on pecans was not received by the 
Agency prior to September 1, 2005, and therefore, was not included in 
the human health risk assessment for exposure to 1,2,4-triazole, 
triazolylalanine and triazolylacetic acid. The Agency has evaluated the 
additional dietary risk from 1,2,4-triazole and the two conjugates 
resulting from the use of tetraconazole on pecans in the Agency's human 
health risk assessment for tetraconazole. The Agency has determined 
that dietary exposure to 1,2,4-triazole, triazolylalanine and 
triazolylacetic acid does not exceed the Agency's level of concern.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (10X) 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 based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA safety factor. 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 FQPA 
safety factor value based on the use of traditional uncertainty/safety 
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 highest dose tested. In the 2-
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. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for tetraconazole is complete.
    ii. There is no indication that tetraconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors to account for neurotoxicity.
    iii. There is no evidence that tetraconazole results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The assumptions and estimates used to model ground and 
surface water concentrations are discussed in Unit III.C.2 and the 
assumptions and estimations underlying the dietary food exposure 
assessments are discussed in Unit III.C.1. These assessments will not 
underestimate the exposure and risks posed by tetraconazole.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short, 
intermediate, and long-term risks are evaluated by comparing aggregate 
exposure to the LOC to ensure that the MOE called for by the product of 
all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tetraconazole will occupy <1.0% of the aPAD for the population group 
(females 13-49 years old) receiving the greatest exposure. No acute 
toxicity endpoint was identified for the remaining population 
subgroups.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
tetraconazole from food and water will utilize <=10.1% of the cPAD for 
the population group all infants <1 year old. There are no residential 
uses for tetraconazole that result in chronic residential exposure to 
tetraconazole. Based on the use pattern, chronic residential exposure 
to residues of tetraconazole is not expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure take 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

[[Page 18133]]

aggregate risk is the sum of the risk from food and water.
    4. Aggregate cancer risk for U.S. population. The estimated cancer 
risk for the proposed use of tetraconazole on sugarbeets, peanuts, 
pecans and soybeans is 3 x 10-6. EPA considers risk 
estimates as high as 3 x 10-6 to be within the negligible 
risk range of 1 x 10-6. This aggregate risk is the sum of 
the risk from food and water.
    5. 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, or to infants and children from aggregate 
exposure to tetraconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromatography 
withelectron 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 in or on the 
relevant crops and commodities.

C. Response to Comments

    One comment was received from a private citizen objecting to the 
establishment of tolerances for tetraconazole. The Agency has received 
similar comments from this commenter on numerous previous occasions. 
Refer to Federal Register 70 FR 37686 (June 30, 2005), 70 FR 1354 
(January 7, 2005), 69 FR 63096-63098 (October 29, 2004) for the 
Agency's response to these objections. In addition, the commenter noted 
several adverse effects seen in animal toxicology studies with 
tetraconazole and claims because of these effects no tolerance should 
be approved. However, EPA found in its tetraconazole risk assessment 
that there is a reasonable certainty of no harm to humans after 
considering the toxicological studies (and the adverse effects seen 
therein) and the exposure levels of humans to tetraconazole. The 
commenter did not provide any information that questioned EPA's risk 
assessment.

V. Conclusion

    Upon completing the review of the current tetraconazole database, 
the Agency concluded that tolerances for hog meat commodities are 
necessary as a result of concern for secondary residues, and a sugar 
beet top tolerance is unnecessary since it is not a human food 
commodity and is being eliminated as a feed commodity from OPPTS 
860.1000. The Agency concluded that the appropriate tolerance levels 
and preferred commodity terms for tetraconazole residues in or on 
pending crops and livestock commodities should be established as 
follows:
    Tolerances are established for residues of tetraconazole in or on 
beet, sugar, root at 0.05 ppm; beet, sugar, dried pulp at 0.15 ppm; 
beet, sugar, molasses at 0.15 ppm; peanut at 0.03 ppm; peanut, oil at 
0.10 ppm; pecan at 0.04 ppm; soybean, seed at 0.15 ppm; soybean, 
refined oil at 0.80 ppm; aspirated grain fractions at 1.0 ppm; poultry, 
meat at 0.01 ppm; poultry, fat at 0.05 ppm; poultry, meat byproducts at 
0.01 ppm; eggs at 0.02 ppm; cattle, meat at 0.01 ppm; cattle, liver at 
0.20 ppm; cattle, fat at 0.02 ppm; cattle, meat byproducts (except 
liver) at 0.01 ppm; milk at 0.01 ppm; milk, fat at 0.25 ppm; goat, meat 
at 0.01 ppm; goat, liver at 0.20 ppm; goat, fat at 0.02 ppm; goat, 
meat, byproducts (except liver) at 0.01 ppm; hog, meat at 0.01 ppm; 
hog, liver at 0.05 ppm; hog, fat at 0.01 ppm; hog, meat byproducts 
(except liver) at 0.01 ppm; horse, meat at 0.01 ppm; horse, liver at 
0.20 ppm; horse, fat at 0.02 ppm; horse, meat, byproducts (except 
liver) at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, liver at 0.20 ppm; 
sheep, fat at 0.02 ppm; sheep, meat, byproducts (except liver) at 0.01 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of 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.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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

[[Page 18134]]

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 2, 2007.
Lois Rossi,
Director, Registration Division, 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 amended by revising paragraph (a), and removing 
and reserving paragraphs (b) and (c) to read as follows.


Sec.  180.557  Tetraconazole; tolerances for residues.

    (a) General. 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:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Aspirated grain fractions............................                1.0
Beet sugar, dried pulp...............................               0.15
Beet sugar, molasses.................................               0.15
Beet sugar, root.....................................               0.05
Cattle, fat..........................................               0.02
Cattle, liver........................................               0.20
Cattle, meat.........................................               0.01
Cattle, meat byproducts (except liver)...............               0.01
Eggs.................................................               0.02
Goat, fat............................................               0.02
Goat, liver..........................................               0.20
Goat, meat...........................................               0.01
Goat, meat byproducts (except liver).................               0.01
Hog, fat.............................................               0.01
Hog, liver...........................................               0.05
Hog, meat............................................               0.01
Hog, meat byproducts (except liver)..................               0.01
Horse, fat...........................................               0.02
Horse, liver.........................................               0.20
Horse, meat..........................................               0.01
Horse, meat byproducts (except liver)................               0.01
Milk.................................................               0.01
Milk, fat............................................               0.25
Peanut...............................................               0.03
Peanut, oil..........................................               0.10
Pecan................................................               0.04
Poultry, fat.........................................               0.05
Poultry, meat........................................               0.01
Poultry meat byproducts..............................               0.01
Sheep, fat...........................................               0.02
Sheep, liver.........................................               0.20
Sheep, meat..........................................               0.01
Sheep, meat byproducts (except liver)................               0.01
Soybean, refined oil.................................               0.80
Soybean, seed........................................               0.15
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registrations. [Reserved].
* * * * *

[FR Doc. E7-6837 Filed 4-10-07; 8:45 am]
BILLING CODE 6560-50-S