[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Rules and Regulations]
[Pages 4284-4288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1614]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0276; FRL-8808-6]


Triticonazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
triticonazole in or on grain, cereal, group 15, except rice, and grain, 
cereal, forage, fodder and straw, group 16, except rice. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 27, 2010. Objections and 
requests for hearings must be received on or before March 29, 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-2009-0276. 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: Tawanda Maignan, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8050; 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).
     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 OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods & Guidelines'' on the left-side navigation menu.

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-2009-0276 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 March 29, 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-2009-0276, 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 August 19, 2009, (74 FR 41900) (FRL-
8426-7), 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 
8F7420) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 
27709-3528. The petition requested that 40 CFR 180.583 be amended by 
establishing tolerances for residues of the fungicide triticonazole, 
(1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-
triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal, group 15, 
except rice, and grain, cereal, forage, fodder and straw, group 16, 
except rice, at 0.05 and 0.10 parts per million (ppm), respectively. 
That notice referenced a summary of the petition prepared by BASF 
Corporation, 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 both the crop group 
terminology, and tolerance levels for

[[Page 4285]]

grain, cereal, group 15, except rice, at 0.01 ppm, and the crop group 
terminology (only) for grain, cereal, forage, fodder and straw, group 
16, except rice, at 0.10 ppm. These tolerances replace previously 
established individual tolerances for barley, grain; barley, hay; 
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, 
straw at 0.05 ppm. The reason for these changes is explained in Unit 
IV.C.

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 triticonazole, (1RS)-(E)-5-[(4-
chlorophenyl)methylene]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol on grain, cereal, group 15, except rice, at 0.01 
ppm, and grain, cereal, forage, fodder and straw, group 16, except 
rice, at 0.10 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.
    Triticonazole has low acute toxicity, is not a skin, eye, or 
respiratory irritant, or a dermal sensitizer. Non-acute toxicity 
studies show that the liver (rat, mouse, dog) and adrenals (rat, dog, 
rabbit) are target organs across species. Adverse body weight changes 
(rat, dog, rabbit, mouse) and clinical signs (rat, dog, mouse) also 
were observed in multiple species. In the developmental and 
reproductive toxicity studies, adverse effects were seen at the same 
dose level in the offspring and parental animals, and the offspring 
were not qualitatively more susceptible compared with adults. In the 
rat subchronic study, decreased thymus weights were reported at a dose 
level (~2,300 milligrams/kilogram/day (mg/kg/day)) two times higher 
than the limit dose (1,000 mg/kg/day). Triticonazole was negative for 
mutagenicity, and the cancer classification is ``Not Likely to Be 
Carcinogenic to Humans'' based on a lack of evidence of carcinogenicity 
in the two guideline studies conducted on rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by triticonazole 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 ``Triticonazole. Human Health Risk 
Assessment for Proposed Seed Treatment Use on Cereal Grains (Crop Group 
15) Including Barley, Field Corn, Oats, Popcorn, Rye, Sorghum Grain, 
Sweet Corn, Triticale, and Wheat (Excluding Rice); and Forage, Fodder, 
and Straw of Cereal Grains (Crop Group 16), Excluding Rice,'' at pages 
34 to 36 in docket ID number EPA-HQ-OPP-2009-0276.

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 triticonazole used for 
human risk assessment can be found at http://www.regulations.gov in the 
document ``Triticonazole. Human Health Risk Assessment for Proposed 
Seed Treatment Use on Cereal Grains (Crop Group 15) Including Barley, 
Field Corn, Oats, Popcorn, Rye, Sorghum Grain, Sweet Corn, Triticale, 
and Wheat (Excluding Rice); and Forage, Fodder, and Straw of Cereal 
Grains (Crop Group 16), Excluding Rice,'' at pages 15 to 16 in docket 
ID number EPA-HQ-OPP-2009-0276.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to triticonazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing triticonazole 
tolerances in 40 CFR 180.583. EPA assessed dietary exposures from 
triticonazole 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 U.S. Department of

[[Page 4286]]

Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed tolerance level residues of triticonazole were found in all 
commodities and that all commodities consumed were 100% crop treated. 
Anticipated residues and/or percent crop treated (PCT) information were 
not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance 
level residues in all commodities, and 100% crop treated for all 
treated commodities. Anticipated residues and/or PCT information were 
not used.
    iii. Cancer. Triticonazole is classified as ``not likely to be 
carcinogenic to humans'' based on the absence of significant tumor 
increases in two adequate rodent carcinogenicity studies. There is no 
evidence that triticonazole is carcinogenic to humans, therefore an 
exposure assessment to evaluate cancer risk is not needed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for triticonazole. Tolerance level residues and/or 
100% crop treated were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for triticonazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of triticonazole. 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.
    The estimated drinking water concentrations (EDWCs) used in the 
dietary risk assessment were provided by OPP's Environmental Fate and 
Effects Division and incorporated directly into the dietary assessment. 
The EDWCs used in the dietary assessment were modeled using the surface 
water model, Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS). For the acute point estimate, the PRZM-EXAMS 1-in-
10 year annual maximum EDWC was used. For the chronic point estimate, 
the PRZM-EXAMS 1-in-10 year annual mean EDWC was used. PRZM-EXAMS EDWCs 
were used because they were higher (and therefore more protective) than 
the groundwater model's, (Screening Concentration in Groudwater model 
(SCI-GROW's)) EDWC. Based on the PRZM/EXAMS, the EDWCs of triticonazole 
for acute exposures are 75.5 parts per billion (ppb) for surface water 
and 5.7 ppb for ground water, and chronic exposures for non-cancer 
assessments are estimated to be 32.8 ppb 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 75.5 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 32.8 ppb 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). Triticonazole is 
currently registered for the following uses that could result in 
residential exposures: Residential and commercial turfgrass, golf 
courses, and sod farms. EPA quantitatively assessed the risk from 
residential exposure to children from children's incidental oral post-
application scenarios (hand to mouth, mouthing grass, and soil 
ingestion). Children and adults may also have post-application dermal 
exposure but dermal toxicity studies with triticonazole did not 
identify any adverse effects from such exposure.
    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.''
    EPA has not found triticonazole to share a common mechanism of 
toxicity with any other substances, and triticonazole does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
triticonazole does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
    Triticonazole 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, or essentially the same, sequence of 
major biochemical events. In conazoles, 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 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.
    Triticonazole and other triazole-containing 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 triticonazole, 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. 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

[[Page 4287]]

Identification (ID) Number EPA-HQ-OPP-2005-0497.

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 the 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 prenatal and postnatal 
toxicity database for triticonazole includes rat and rabbit 
developmental toxicity studies and a two generation reproduction study 
in rats. There is no evidence of increased susceptibility following in 
utero and/or postnatal exposure in the developmental toxicity studies 
in rats or rabbits, and in the 2-generation rat reproduction study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for triticonazole is complete with the 
exception of a newly required immunotoxicity study. In accordance with 
40 CFR Part 158 toxicity data requirements, an immunotoxicity study 
(Harmonized guideline 870.7800) is required for triticonazole. In the 
absence of specific immunotoxicity studies, EPA has evaluated the 
available triticonazole toxicity data to determine whether an 
additional uncertainty factor is needed to account for potential 
immunotoxicity. The toxicological database for triticonazole does not 
indicate that the immune system is the primary target organ. Decreased 
thymus weight was observed in only one species (rat) at the highest 
dose tested (~2x the limit dose of 1,000 mg/kg/day); these findings may 
be due to secondary effects of overt systemic toxicity. Based on this 
evidence, EPA does not believe that conducting immunotoxicity testing 
will result in a point of departure lower than those already selected 
for triticonazole risk assessment, and an additional uncertainty factor 
is not needed to account for potential immunotoxicity.
    ii. There are no indications that triticonazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that triticonazole 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 
database. The dietary food exposure assessments were performed based on 
100% crop treated and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to triticonazole in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the acute population 
adjusted dose (aPAD) and chronic population adjusted dose (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 combined acute dietary exposure from food 
and water to triticonazole will occupy < 1% of the aPAD for (females 13 
to 49 years old), the population subgroups receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
triticonazole from food and water will utilize 1.4% of the cPAD for all 
infants (< 1 year old), the subgroup receiving the greatest exposure. 
Based on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of triticonazole is 
not expected.
    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). Triticonazole 
is currently registered for use(s) 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 triticonazole.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
water, and residential exposures aggregated result in aggregate MOEs 
of: 1,100 for children 1 to 2 years old, and 1,100 for all infants < 1 
year old. Because the level of concern is for MOEs below 100, these 
MOEs are not of concern.
    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). Triticonazole is currently registered for use(s) that could 
result in intermediate-term residential exposure and the Agency has 
determined that it is appropriate to aggregate chronic exposure to 
triticonazole through food and water with intermediate-term exposures 
for triticonazole.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures aggregated 
result in aggregate MOEs of: 780 for children 1 to 2 years old, and 740 
for all infants < 1 year old. Because the level of concern is for MOEs 
below 100, these MOEs are not of concern.
     5. Aggregate cancer risk for U.S. population. Triticonazole is 
classified as ``not likely to be carcinogenic to humans'' based on the 
absence of significant tumor increases in two adequate rodent 
carcinogenicity studies. Thus, triticonazole is not expected to pose a 
cancer risk.
    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 triticonazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry (LC/MS), and liquid chromatography/mass spectrometry/mass 
spectrometry (LC/MS/MS) methods (Method 148.02) is available to

[[Page 4288]]

enforce the tolerance expression. These methods 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 or Mexican maximum residue levels 
(MRLs)/tolerances for triticonazole on wheat or barley. Triticonazole 
is registered as a seed treatment in Canada for oats, barley, and 
wheat, and has established MRL levels at 0.01 ppm on barley, oats, and 
wheat and for livestock commodities at 0.05 ppm. The Canadian MRLs on 
barley, oats, and wheat are in harmony with the United States' 0.01 ppm 
tolerance level for grain, cereal, group 15, except rice. Additionally, 
no U.S. tolerances have been established on livestock commodities. No 
harmonization issues exist in connection with the proposed use on turf.

C. Revisions to Petitioned-for Tolerances

    EPA determined the tolerances for grain, cereal, group 15, except 
rice, should be established at 0.01 ppm, based on a harmonization 
concern with Canada, and residue data which supported this tolerance 
level. Thus the proposed tolerance level of 0.05 ppm was deemed 
excessive. Upon establishing the grain, cereal, group 15, except rice, 
tolerance at 0.01 ppm, the individual tolerances established for 
barley, straw; wheat, forage; wheat, grain; wheat, hay; and wheat, 
straw at 0.05 ppm are being removed from 40 CFR 180.583(a).

V. Conclusion

    Therefore, tolerances are established for residues of 
triticonazole, (1RS)-(E)-5-[(4-chlorophenyl)methylene]-2,2-dimethyl-1-
(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, in or on grain, cereal, 
group 15, except rice, at 0.01 ppm, and grain, cereal, forage, fodder 
and straw, group 16, except rice, at 0.10 ppm.

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 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: January 19, 2010.
 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 180.583 is amended by revising the table in paragraph (a) to 
read as follows:


Sec.  180.583  Triticonazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Grain, cereal, forage, fodder and straw, group 16, except           0.10
 rice......................................................
Grain, cereal, group 15, except rice.......................         0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-1614 Filed 1-26-10; 8:45 am]
BILLING CODE 6560-50-S