
[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Rules and Regulations]               
[Page 24421-24428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-16]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0611; FRL-8821-4]

 
Tebuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tebuconazole in or on vegetable, fruiting, group 8. Bayer CropScience 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective May 5, 2010. Objections and 
requests for hearings must be received on or before July 6, 2010, 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-OPP-2009-0611. All documents in the 
docket are listed in the docket index available at http://
www.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 Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Tracy Keigwin, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6605; e-mail address: keigwin.tracy @epa.gov.

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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0611 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 July 6, 2010.
    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-2009-0611, 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 Facility'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 Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of September 4, 2009 (74 FR 45848) (FRL-
8434-4), 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 
9F7515) by Bayer CropScience, 2 T.W. Alexander Dr., P.O. Box 12014, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
part 180 be amended by establishing tolerances for residues of the 
fungicide tebuconazole in or on the raw agricultural commodity 
vegetables, fruiting, group at 1.4 parts per million (ppm). That notice 
referenced a summary of the petition prepared by Bayer CropScience, 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.
    Based upon review of the data supporting the petition, EPA has 
modified the proposed tolerance to 1.3 ppm. The reason for this change 
is explained in Unit IV.C.

[[Page 24422]]

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of 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 for the petitioned-for 
tolerances for residues of tebuconazole on vegetables, fruiting, group 
8 at 1.3 ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances 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.
    Tebuconazole has low acute toxicity by the oral or dermal route of 
exposure, and moderate toxicity by the inhalation route. It is not a 
dermal sensitizer or a dermal irritant; however, it is slightly to 
mildly irritating to the eye. The main target organs are the liver, the 
adrenals, the hematopoetic system and the nervous system. Effects on 
these target organs were seen in both rodent and non-rodent species. In 
addition, ocular lesions are seen in dogs (including lenticular 
degeneration and increased cataract formation) following subchronic or 
chronic exposure.
    Oral administration of tebuconazole caused developmental toxicity 
in all species evaluated (rat, rabbit, and mouse), with the most 
prominent effects seen in the developing nervous system. In the 
available toxicity studies on tebuconazole, there was no 
toxicologically significant evidence of endocrine disruptor effects. 
Tebuconazole was classified as a Group C possible human carcinogen, 
based on an increase in the incidence of hepatocellular adenomas, 
carcinomas and combined adenomas/carcinomas in male and female mice. 
Submitted mutagenicity studies did not demonstrate any evidence of 
mutagenic potential for tebuconazole.
    Specific information on the studies received and the nature of the 
adverse effects caused by tebuconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in the document entitled ``Tebuconazole: Human 
Health Risk Assessment to support tolerances in/on Asparagus, Barley, 
Beans, Beets, Brassica leafy greens, Bulb Vegetables, Coffee (import), 
Commercial Ornamentals, Corn, Cotton, Cucurbits, Hops, Lychee, Mango, 
Okra, Pome fruit, Soybean, Stone fruit, Sunflower, Tree Nut Crop Group, 
Turf, Turnips and Wheat,'' pages 83-105 in docket ID number EPA-HQ-OPP-
2005-0097-0004.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as 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) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. 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/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for tebuconazole used for 
human risk assessment is shown in the Table of this unit.

[[Page 24423]]



      Table--Summary of Toxicological Doses and Endpoints for Tebuconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                       Point of Departure and
          Exposure/Scenario              Uncertainty/Safety     RfD, PAD, LOC for Risk   Study and Toxicological
                                              Factors                 Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                         LOAEL = 8.8 milligram/   Acute RfD = 0.029 mg/kg/ Developmental
 (General population including         kilogram/day (mg/kg/     day                      Neurotoxicity Study -
 infants and children, Females 13-50   day)                    aPAD = 0.029 mg/kg/day.   Rat.
 years of age).                       UF = 300...............                           LOAEL = 8.8 mg/kg/day
                                      UFA = 10x..............                            based on decreases in
                                      UFH = 10x..............                            body weights, absolute
                                      FQPA (UFL) = 3x........                            brain weights, brain
                                                                                         measurements and motor
                                                                                         activity in offspring.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                       LOAEL = 8.8 mg/kg/day    Chronic RfD = 0.029 mg/  Developmental
(All populations)...................  UF = 300...............   kg/day                   Neurotoxicity Study -
                                      UFA = 10x..............  cPAD = 0.029 mg/kg/day.   Rat.
                                      UFH = 10x..............                           LOAEL = 8.8 mg/kg/day
                                      FQPA (UFL) = 3x........                            based on decreases in
                                                                                         body weights, absolute
                                                                                         brain weights, brain
                                                                                         measurements and motor
                                                                                         activity in offspring.
----------------------------------------------------------------------------------------------------------------
Incidental oral short term/           LOAEL = 8.8 mg/kg/day    Residential LOC for MOE  Developmental
 Intermediate term                    UF = 300...............   = 300                    Neurotoxicity Study -
(1 to 30 days/1-6 months)...........  UFA = 10x..............                            Rat.
                                      UFH = 10x..............                           LOAEL = 8.8 mg/kg/day
                                      FQPA (UFL) = 3x........                            based on decreases in
                                                                                         body weights, absolute
                                                                                         brain weights, brain
                                                                                         measurements and motor
                                                                                         activity in offspring.
----------------------------------------------------------------------------------------------------------------
Dermal short term/Intermediate term   LOAEL = 8.8 mg/kg/day    Residential LOC for MOE  Developmental
(1 to 30 days/1 to 6 months)........  UF = 300...............   = 300                    Neurotoxicity Study -
                                      UFA = 10x..............                            Rat.
                                      UFH = 10x..............                           LOAEL = 8.8 mg/kg/day
                                      UFL = 3x...............                            based on decreases in
                                      DAF = 23.1%............                            body weights, absolute
                                                                                         brain weights, brain
                                                                                         measurements and motor
                                                                                         activity in offspring.
----------------------------------------------------------------------------------------------------------------
Inhalation short term/Intermediate    LOAEL = 8.8 mg/kg/day    Residential LOC for MOE  Developmental
 term                                 UF = 300...............   = 300                    Neurotoxicity Study -
(1 to 30 days/1 to 6 months)........  UFA = 10x..............                            Rat.
                                      UFH = 10x..............                           LOAEL = 8.8 mg/kg/day
                                      UFL = 3x...............                            based on decreases in
                                      Inhalation and oral                                body weights, absolute
                                       toxicity are assumed                              brain weights, brain
                                       to be equivalent.                                 measurements and motor
                                                                                         activity in offspring.
----------------------------------------------------------------------------------------------------------------
Cancer                                 Classification: Group C-possible human carcinogen based on statistically
(Oral, dermal, inhalation)..........        significant increase in the incidence of hepatocellular adenoma,
                                         carcinoma, and combined adenoma/carcinomas in both sexes of NMRI mice.
                                        Considering that there was no evidence of carcinogenicity in rats, there
                                         was no evidence of genotoxicity for tebuconazole, and tumors were only
                                       seen at a high and excessively toxic dose in mice, EPA concluded that the
                                       chronic RfD would be protective of any potential carcinogenic effect. The
                                         chronic RfD value is 0.029 mg/kg/day which is approximately 9,600 fold
                                          lower than the dose that would induce liver tumors (279 mg/kg/day).
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tebuconazole, EPA considered exposure under the petitioned-
for tolerances as well as all existing tebuconazole tolerances in 40 
CFR 180.474. EPA assessed dietary exposures from tebuconazole 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, anticipated residues 
for bananas, grapes, raisins, nectarines, peaches, peanut butter and 
wheat were derived using the latest USDA Pesticide Data Program (PDP) 
monitoring data. Anticipated residues for all other registered and 
proposed food commodities were based on field trial data. For uses 
associated with PP 9F7515, 100 percent crop treated (PCT) was assumed. 
Dietary Exposure Evaluation Model (ver. 7.81) default processing 
factors were assumed for processed commodities associated with petition 
9F7515. For several other uses

[[Page 24424]]

EPA used PCT data as specified in Unit III.C.1.iv.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the same assumptions as stated in Unit III.C.1.i. 
for acute exposure.
    iii. Cancer. As explained in Unit III.B., the chronic risk 
assessment is considered to be protective of any cancer effects; 
therefore, a separate quantitative cancer dietary risk assessment was 
not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of 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 require pursuant to section 
408(f)(1) of FFDCA 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 section 
408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. 
Data will be required to be submitted no later than 5 years from the 
date of issuance of these tolerances.
    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:
     Condition 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 the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition 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.
    The Agency used PCT information as follows:
    Grapes: 25%; grape, raisin: 25%; nectarine 25%; oats 2.5%; peach: 
20%; and peanuts 45%.
    In most cases, EPA uses available data from the USDA's National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency used projected percent crop treated (PPCT) information 
for tebuconazole on apples, apricots, cherries (preharvest), sweetcorn, 
hops, plums, and turnips. The PPCT for each crop is as follows: Apples, 
acute assessment 44%, chronic assessment 41%; apricots: acute 
assessment 56%, chronic assessment 43%; cherries, preharvest: acute 
assessment 42%, chronic assessment 37%; corn, sweet: acute assessment 
22%, chronic assessment 14%; hops: acute assessment 64%, chronic 
assessment 64%; plum: acute assessment 26%, chronic assessment 24%; 
turnip: acute assessment 68%, chronic assessment 44%. EPA estimates 
PPCT for a new pesticide use by assuming that its actual PCT during the 
initial 5 years of use on a specific use site will not exceed the 
recent PCT of the market leader (i.e., the one with the greatest PCT) 
on that site. An average market leader PCT, based on three recent 
surveys of pesticide usage, if available, is used for chronic risk 
assessment, while the maximum PCT from the same three recent surveys, 
if available, is used for acute risk assessment. The average and 
maximum market leader PCTs may each be based on one or two surveys if 
three are not available. 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 market leader 
PCTs used to determine the average and the maximum may be each for the 
same pesticide or for different pesticides since the same or different 
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as 
the source for raw PCT data because it is publicly available. When a 
specific use site is not surveyed by USDA/NASS, EPA uses other sources 
including proprietary data.
    An estimated PPCT, based on the average PCT of the market leaders, 
is appropriate for use in chronic dietary risk assessment, and an 
estimated PPCT, based on the maximum PCT of the market leaders, is 
appropriate for use in acute dietary risk assessment. This method of 
estimating PPCTs for a new use of a registered pesticide or a new 
pesticide produces high-end estimates that are unlikely, in most cases, 
to be exceeded during the initial 5 years of actual use. Predominant 
factors that bear on whether the PPCTs could be exceeded may include 
PCTs of similar chemistries, pests controlled by alternatives, pest 
prevalence in the market and other factors. All relevant information 
currently available for predominant factors have been considered for 
tebuconazole on cherries, resulting in adjustments to the initial 
estimates for three crops to account for lack of confidence in 
projections based on less than three observations, old data and/or data 
based on expert opinion.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, 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 reliable information on the regional consumption of 
food to which tebuconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tebuconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tebuconazole. 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.

[[Page 24425]]

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI 
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tebuconazole for acute exposures are estimated to be 47.23 micrograms/
Liter ([mu]g/L) for surface water and 0.447 [mu]g/L for ground water. 
The EDWCs for chronic, noncancer are estimated to be 16.97 [mu]g/L for 
surface water and 0.447 [mu]g/L for ground water. The EDWCs for 
chronic, cancer exposures are estimated to be 12.14 for surface water 
and 0.447 [mu]g/L for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 47.23 [mu]g/L was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment (which is protective of any possible cancer effects), the 
water concentration value of 16.97 [mu]g/L was used to assess 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).
    Tebuconazole has currently registered uses that could result in 
residential exposures. Short term dermal and inhalation exposures are 
possible for residential adult handlers mixing, loading, and applying 
tebuconazole products outdoors to ornamental plants. Short- and 
intermediate-term dermal postapplication exposures to adults and 
children are also possible during golfing and/or playing on treated 
wood structures. Children may also be exposed via the incidental oral 
route when playing on treated wood structures. Long-term exposure is 
not expected. As a result, risk assessments have been completed for 
residential handler scenarios as well as residential post-application 
scenarios.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    Tebuconazole is a member of the triazoles (and more specifically, 
triazole-derivative fungicides). Although triazoles 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, or essentially the 
same, sequence of major biochemical events. In triazole-derivative 
fungicides, however, a variable pattern of toxicological responses is 
found: Some are hepatotoxic and hepatocarcinogenic in mice; some induce 
thyroid tumors in rats; and some induce developmental, reproductive, 
and neurological effects in rodents. Furthermore, the triazoles 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 triazole-derivative fungicides share common 
mechanisms of toxicity and EPA is not following a cumulative risk 
approach based on a common mechanism of toxicity for the triazole-
derivative fungicides. 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.
    However, the triazole-derivative fungicides can form the common 
metabolites 1,2,4-triazole and conjugated triazole metabolites. To 
support existing tolerances and to establish new tolerances for 
triazole-derivative fungicides, including tebuconazole, 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-derivative fungicide. 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 the Food Quality Protection Act (FQPA) Safety Factor (SF) 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 ID number EPA-HQ-OPP-2005-0497.
    In connection with the pending new uses of tebuconazole (and other 
triazole-derivative fungicides), the Agency has revised the triazole 
dietary assessment to include the new uses of tebuconazole and has 
determined that aggregate risk (food, water and residential) remains 
below the Agency's level of concern. This revised assessment can be 
found at http://www.regulations.gov in docket ID EPA-HQ-OPP-2009-0061.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) 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 database 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 FQPA SF. In 
applying this provision, EPA either retains the default value of 10x, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The toxicity database for 
tebuconazole is complete, and includes prenatal developmental toxicity 
studies in three species (mouse, rat, and rabbit), a reproductive 
toxicity study in rats, acute and subchronic neurotoxicity studies in 
rats, and a developmental neurotoxicity study in rats. The data from 
prenatal developmental toxicity studies in mice and a developmental 
neurotoxicity study in rats indicated an increased quantitative and 
qualitative susceptibility following in utero exposure to tebuconazole. 
The NOAELs/LOAELs for developmental toxicity in these studies were 
found at dose levels less than those that induce maternal toxicity or 
in the presence of slight maternal toxicity. There was no indication of 
increased quantitative susceptibility in the rat and rabbit 
developmental toxicity studies, the NOAELs for developmental toxicity 
were comparable to or higher than the NOAELs for maternal toxicity. In 
all three species, however, there was indication of increased 
qualitative susceptibility. For most studies, minimal maternal toxicity 
was seen at the LOAEL (consisting of increases in hematological 
findings in mice, increased liver weights in rabbits and rats, and 
decreased body weight gain/food consumption in rats) and did not

[[Page 24426]]

increase substantially in severity at higher doses; however, there was 
more concern for the developmental effects at each LOAEL which included 
increases in runts, increased fetal loss, and malformations in mice, 
increased skeletal variations in rats, and increased fetal loss and 
frank malformations in rabbits. Additionally, more severe developmental 
effects (including frank malformations) were seen at higher doses in 
mice, rats and rabbits. In the developmental neurotoxicity study, 
maternal toxicity was seen only at the high dose (decreased body 
weights, body weight gains, and food consumption, prolonged gestation 
with mortality, and increased number of dead fetuses), while offspring 
toxicity (including decreases in body weight, brain weight, brain 
measurements and functional activities) was seen at all doses.
    Available data indicated greater sensitivity of the developing 
organism to exposure to tebuconazole, as demonstrated by increases in 
qualitative sensitivity in prenatal developmental toxicity studies in 
rats, mice, and rabbits, and by increases in both qualitative and 
quantitative sensitivity in the developmental neurotoxicity study in 
rats with tebuconazole. However, the degree of concern is low because 
the toxic endpoints in the prenatal developmental toxicity studies were 
well characterized with clear NOAELs established and the most sensitive 
endpoint from the developmental neurotoxicity study is used for overall 
risk assessments. Therefore, there are no residual uncertainties for 
prenatal and/or postnatal susceptibility.
    There is a concern with regard to the DNT study because of the 
failure to achieve a NOAEL in that study. This concern is addressed by 
the retention of FQPA SF in the form of UFL of 3x. Reduction 
of the FQPA safety factor from 10x to 3x is based on a Benchmark Dose 
(BMD) analysis of the datasets relevant to the adverse offspring 
effects (decreased body weight, decreases in absolute brain weights, 
changes in brain morphometric parameters, and decreases in motor 
activity) seen at the LOAEL in the DNT study. All of the BMDLs (the 
lower limit of a one-sided 95% confidence interval on the BMD) modeled 
successfully on statistically significant effects are 1-2x lower than 
the LOAEL. The results indicate that the extrapolated NOAEL is not 
likely to be 10x lower than the LOAEL and that the use of the FQPA SF 
of 3x would not underestimate risk. Using a 3x FQPA SF in the risk 
assessment (8.8 mg/kg/day / 3x = 2.9 mg/kg/day) is further supported by 
the NOAELs established in other studies in the tebuconazole toxicity 
database [i.e., 3 and 2.9 mg/kg/day, from a developmental toxicity 
study in mice and a chronic toxicity study in dogs, respectively 
(respective LOAELs 10 and 4.5 mg/kg/day)].
    3. Conclusion. The Agency has determined that reliable data show 
that it would be safe for infants and children to reduce the FQPA SF to 
3x for all potential exposure scenarios. That decision is based on the 
following findings:
    i. The toxicity database for tebuconazole is complete with the 
exception of an immunotoxicity study requirement under the new 40 CFR 
part 158 guidelines for toxicity data. The available guideline studies 
do not suggest that tebuconazole directly targets the immune system. A 
peer-reviewed developmental neurotoxicity/immunotoxicity literature 
study (Moser et al., 2001) found in high dose groups (60 mg/kg/day) 
increased spleen weights and alterations in splenic lymphocyte 
subpopulations. At the same dose there were no effects seen in the T-
cell dependent antibody response to SRBC (sheep red blood cells) and 
natural killer (NK) cell activity indicating that tebuconazole did not 
alter the functional immune response in rats. Based on guideline and 
open literature, the overall weight of evidence suggests that 
tebuconazole does not directly target the immune system. The Agency 
does not believe that conducting a functional immunotoxicity study will 
result in a lower POD than currently used for overall risk assessment; 
therefore, a database uncertainty factor (UFDB) is not needed to 
account for the lack of the study.
    ii.Although there is qualitative evidence of increased 
susceptibility in the prenatal developmental studies in rats, the risk 
assessment team did not identify any residual uncertainties after 
establishing toxicity endpoints and traditional UFs to be used in the 
risk assessment of tebuconazole. The degree of concern for residual 
uncertainties for prenatal and/or postnatal toxicity is low.
    iii.The FQPA SF is retained as a UFL. Reduction of the 
UFL from 10 to 3x is based on a BMD analyses of the datasets 
relevant to the adverse offspring effects (decreased body weight and 
brain weight) seen at the LOAEL in the DNT study. All of the BMDLs 
modeled successfully on statistically significant effects are 1-2x 
lower than the LOAEL. The results indicate that an extrapolated NOAEL 
is not likely to be 10x lower than the LOAEL and that use of an 
UFL of 3x would not underestimate risk. Using an 
UFL of 3x in risk assessment (8.8 mg/kg/day / 3x = 2.9 mg/
kg/day) is further supported by other studies in the tebuconazole 
toxicity database [with the lowest NOAELs being 3 and 2.9 mg/kg/day, 
from a developmental toxicity study in mice and a chronic toxicity 
study in dogs, respectively (respective LOAELs 10 and 4.5 mg/kg/day)].
    iv.There are no residual uncertainties identified in the exposure 
databases. Although the acute and chronic food exposure assessments are 
refined, EPA believes that the assessments are based on reliable data 
and will not underestimate exposure/risk. The drinking water estimates 
were derived from conservative screening models. The residential 
exposure assessment utilizes reasonable high-end variables set out in 
EPA's Occupational/Residential Exposure SOPs (Standard Operating 
Procedures). The aggregate assessment is based upon reasonable worst-
case residential assumptions, and is also not likely to underestimate 
exposure/risk to any subpopulation, including those comprised of 
infants and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs 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 tebuconazole will occupy 56% of the aPAD for the population group 
(children 3-5 years old) receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
tebuconazole from food and water will utilize 4.9% of the cPAD for the 
U.S. population and 7.5% of the cPAD for the most highly exposed 
population group (children 1-2 years old).

[[Page 24427]]

    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Tebuconazole 
is currently registered for uses that could result in short-term 
residential exposure and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to tebuconazole.
    Using the exposure assumptions described in this unit for short 
term exposures, EPA has concluded that the short-term aggregate MOE 
from dietary exposure (food + drinking water) and non-occupational/
residential handler exposure for adults using a hose-end sprayer on 
ornamentals is 390. The short-term aggregate MOE from dietary exposure 
and exposure from golfing is 1,700. The short-term aggregate MOE to 
children from dietary exposure and exposure from wood surfaces treated 
at the above ground use rate is 520. The short-term aggregate MOE to 
children from dietary exposure and exposure to wood surfaces treated at 
the below ground use rate is 230. The combined and aggregate MOEs for 
wood treated for below ground uses exceed the Agency's LOC, and 
indicate a potential risk of concern. However, the combined MOE for 
wood treated for above-ground uses does not exceed the LOC, and 
therefore is not of concern. Exposure to above-ground wood is expected 
to more closely represent actual exposures to children. Frequency of 
exposures to above-ground wood should greatly exceed any exposures to 
below-ground wood, and exposures to below ground wood would be minimal, 
or negligible. It is unrealistic to expect a full duration of exposure 
to below ground wood. Therefore, this assessment should be 
characterized as a conservative screening-level assessment.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Tebuconazole is currently registered for uses that could result 
in intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to tebuconazole. 
Since the POD, relevant exposure scenarios and exposure assumptions 
used for intermediate-term aggregate risk assessments are the same as 
those used for short-term aggregate risk assessments, the short-term 
aggregate risk assessments represent and are protective of both short- 
and intermediate-term exposure durations.
    5. Aggregate cancer risk for U.S. population. As discussed in this 
unit, the chronic risk assessment is considered to be protective of any 
cancer effects; therefore, because the chronic risk assessment 
indicates exposure is lower than the cPAD, tebuconazole does not pose a 
cancer risk of concern.
    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, or to infants and children from aggregate 
exposure to tebuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate gas chromatography/nitrogen phosphorus detector (GC/NPD) 
and liquid chromatography/mass spectrometry (LC/MS/MS) methods are 
available for both collecting and enforcing tolerances for tebuconazole 
and its metabolites in plant commodities, livestock matrices and 
processing studies. The methods have been adequately validated by an 
independent laboratory in conjunction with a previous petition. 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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    Codex and Canada have established maximum residue limits (MRLs) for 
tebuconazole in/on a variety of plant and livestock commodities. The 
tolerance expression for tebuconazole is harmonized between the United 
States, Codex, and Canada. There are currently no established Codex, 
Canadian, or Mexican MRLs for tebuconazole on fruiting vegetables. 
However, there are CODEX MRLs for chili pepper at 5 ppm and sweet 
pepper and tomato at 0.5 ppm. The Codex MRLs are based on European 
field trials, where the single application rate is approximately 
equivalent to the U.S. single application rate but the pre-harvest 
interval (PHI) is 3 days in the European Union as opposed to a PHI of 0 
days in the United States. Given these different use practices, 
international harmonization is not possible at this time.

C. Revisions to Petitioned-For Tolerances

    Based upon review of the data supporting the petition, EPA 
determined that the proposed tolerances for vegetable, fruiting, group 
8, should be reduced to 1.3 ppm from 1.4 ppm. EPA revised these 
tolerance levels based on analysis of the residue field trial data 
using the Agency's ``Tolerance Spreadsheet'' in accordance with the 
Agency's ``Guidance for Setting Pesticide Tolerances Based on Field 
Trial Data Standard Operating Procedure (SOP).''

V. Conclusion

    Therefore, tolerances are established for residues of the fungicide 
tebuconazole, including its metabolites and degradates, in or on 
vegetable, fruiting, group 8 at 1.3 ppm Compliance with the tolerance 
levels specified in Unit IV.C. is to be determined by measuring only 
tebuconazole (alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol), in or on vegetable, 
fruiting, group 8.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled 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

[[Page 24428]]

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 9, 2000) do not apply to this final rule. In addition, 
this final 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 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 20, 2010.
G. Jeffrey Herndon,
Acting 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 180.474 is amended by revising the introductory text of 
paragraphs (a)(1), (a)(2), and (c) and alphabetically add the commodity 
``vegetable, fruiting, group 8'' to the table in paragraph (a)(1) to 
read as follows:


Sec.  180.474  Tebuconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
fungicide tebuconazole, including its metabolites and degradates, in or 
on the commodities in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only tebuconazole (alpha-[2-(4-chlorophenyl)ethyl]-alpha-
(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol), in or on the 
commodity.

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Vegetable, fruiting, group 8...................                      1.3
                                * * * * *
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the fungicide 
tebuconazole, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only the sum of tebuconazole (alpha-[2-(4-
chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol) and its diol metabolite (1-(4-chlorophenyl)-4,4-dimethyl-3-(1H 
-1,2,4-triazole-1-yl-methyl)-pentane-3,5-diol), calculated as the 
stoichiometric equivalent of tebuconzole, in or on the commodity.
* * * * *
    (c) Tolerances with Regional Registrations. Tolerances are 
established for residues of the fungicide tebuconazole, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified below is to be 
determined by measuring only tebuconazole, alpha-[2-(4-
chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-
ethanol, in or on the commodity.
* * * * *

[FR Doc. 2010-10406 Filed 5-4-10; 8:45 am]
BILLING CODE 6560-50-S

