[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55293-55300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7957]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0053; FRL-8093-9]


Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-
(1H-1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-
5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond; almond, 
hulls; apple; apple wet pomace; banana; beet, sugar, dried pulp; beet, 
sugar, molasses; beet, sugar, roots; beet, sugar, tops; bushberry 
subgroup 13B; cattle, meat byproducts; citrus, dried pulp; citrus, oil; 
cranberry; fruit, citrus, group 10; fruit, stone, group 12; goat, meat 
byproducts; grain, aspirated fractions; grape; horse, meat byproducts; 
peanut; pecan; sheep, meat byproducts; wheat, forage; wheat, grain; 
wheat, hay; and wheat, straw. EPA is also deleting several existing 
tolerances that are no longer needed as a result of this action. Dow 
AgroSciences requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA).

DATES: This regulation is effective September 22, 2006. Objections and 
requests for hearings must be received on or before November 21, 2006, 
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-2005-0053. All documents in the 
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9443; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be 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.

[[Page 55294]]

B. How Can I Access Electronic Copies of this Document?

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2005-0053 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before November 21, 2006.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2005-0053, 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 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 20, 2005, 70 FR 41718 (FRL-7702-7), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of pesticide petitions (PP 0E6208, PP 
1E6252, PP 1F3989, PP 1F3995, PP 2F4127, PP 2F4135, PP 2F4154, PP 
3F4914, PP 4F6879, PP 7F4887, PP 9E5041, and PP 9F6024) by Dow 
AgroSciences LLC, 9330 Zionsville Road, Indianapolis, Indiana 46268-
1054. The petition requested that 40 CFR 180.480 be amended by 
establishing tolerances for combined residues of the fungicide 
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites cis-5-(4-
chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanone and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05 parts per 
million (ppm) (PP 3F4194); almond, hulls at 3.0 ppm (PP 3F4194); apple 
at 0.4 ppm (PP 2F4135); apple, wet pomace at 1.0 ppm (PP 2F4135); 
banana at 0.3 ppm (PP 2F4154); blueberry at 0.3 ppm (PP 9E5041); 
cranberry at 1.0 ppm (PP 1E6252); fruit, citrus, group 10 at 1.0 ppm 
(PPs 7F4900 and 4F6879); fruit, stone, group 12 (except plum, prune) at 
2.0 ppm (PP 1F3989); grape at 1.0 ppm (PP 0E6208); pecan at 0.1 ppm (PP 
1F3995); plum at 2.0 ppm (PP 1F3989); plum, prune, dried at 7.0 ppm (PP 
1F3989); sugar beet, dried pulp at 1.0 ppm (PP 7F4887); sugar beet, 
molasses at 0.4 ppm (PP 7F4887); sugar beet, roots at 0.2 ppm (PP 
7F4887); sugar beet, tops at 9.0 ppm (PP 7F4887); wheat, grain at 0.05 
ppm (PP 2F4127); and wheat, straw (PP 2F4127) at 10.0 ppm; establishing 
tolerances for combined residues of the fungicide fenbuconazole, 
[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile, and its metabolite [alpha]-(2-(4-chloro-3-
(D-glucopyranosyloxy)-phenyl)ethyl)-[alpha]-phenyl-1H-1,2,4-triazole-1-
propanenitrile, in or on peanut at 0.1 ppm (PP 9F6024) and peanut, hay 
at 20 ppm (PP 9F6024); by establishing tolerances for combined residues 
of the fungicide fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-
[alpha]-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile, and its 
metabolites cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone, trans-5-(4-chlorophenyl)-dihydro-3-
phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, and 4-chloro-
[alpha]-hydroxymethyl-[alpha]-phenyl-benzenebutanenitrile in or on fat 
of cattle, goats, hogs, horses, and sheep at 0.05 ppm (PP 2F4127), and 
liver of cattle, goats, hogs, horses, and sheep at 0.3 ppm (PP 2F4127). 
That notice included a summary of the petition prepared by Dow 
AgroSciences LLC, the registrant. There were no comments received in 
response to the notice of filing.
    EPA is also deleting several established time-limited tolerances in 
Sec.  180.480(b) that are no longer needed. These revisions are as 
follows:
    i. Delete the cattle, goat, horse, and sheep meat byproducts 
tolerances, each for 0.01 ppm and expiring on December 31, 2008. These 
tolerances are replaced by permanent tolerances of 0.05 ppm for cattle, 
goat, horse, and sheep meat byproducts, respectively.
    ii. Delete the grapefruit tolerance of 0.5 ppm that expires on 
December 31, 2008. It is replaced by a permanent tolerance of 1.0 ppm 
for fruit, citrus, group 10.
    iii. Delete the grapefruit, dried pulp tolerance of 4.0 ppm that 
expires on December 31, 2008. It is replaced by a permanent tolerance 
of 5.0 ppm for citrus, dried pulp.
    iv. Delete the grapefruit, oil tolerance of 35 ppm that expires on 
December 31, 2008. It is replaced by a permanent tolerance of 40.0 ppm 
for citrus, oil.
    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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the

[[Page 55295]]

FFDCA and a complete description of the risk assessment process, see 
http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm, 
http://www.epa.gov/oppfead1/trac/science, http://www.epa.gov/pesticides/factsheets/riskassess.htm, and http://www.epa.gov/pesticides/trac/science/aggregate.pdf.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for tolerances for combined residues of 
fenbuconazole, [alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile), and its metabolites RH-9129, cis-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-
3H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone, in or on almond at 0.05 
ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace at 
1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; beet, 
sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet, sugar, 
tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat 
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at 
40.0 ppm; cranberry at 0.5 ppm; goat, meat byproducts at 0.05 ppm; 
fruit, citrus, group 10 at 1.0 ppm; fruit, stone, group 12 at 1.0 ppm; 
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat 
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep, 
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at 
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
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. Specific information on the studies received and the nature 
of the toxic effects caused by fenbuconazole 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, Docket Identification (ID) Number EPA-HQ-OPP-2005-
0053.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for fenbuconazole used for 
human risk assessment is shown below in Table 1 of this document.

    Table 1.--Summary of Toxicological Dose and Endpoints for Fenbuconazole for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment;          Special FQPA Safety
          Exposure Scenario                Interspecies and      Factor (SF); Level of     Study; Endpoint and
                                         Intraspecies and any       Concern for Risk      Toxicological Effects
                                            Traditional UF             Assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-49 years of  NOAEL = 30 mg/kg/day;    Special FQPA SF = 1;     Rat developmental
 age)                                  UF = 100; Acute RfD\1\   aPAD = acute RfD\1\ /     study;
                                        = 0.3 mg/kg/day.         Special FQPA SF = 0.3   Developmental LOAEL =
                                                                 mg/kg/day.               75 mg/kg/day based on
                                                                                          increased resorptions
                                                                                          and decreased live
                                                                                          fetuses per dam
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population      No NOAEL was             Special FQPA SF is not   No study was selected
 including infants and children)        identified; UF is not    applicable; no aPAD\2\   because no appropriate
                                        applicable; no Acute     was calculated.          dose and endpoint
                                        RfD\1\ was calculated.                            could be identified
                                                                                          for this population
                                                                                          group
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 3 mg/kg/day; UF   Special FQPA SF = 1;     Rat combined chronic
                                        = 100; Chronic RfD\1\    cPAD\3\ = chronic        toxicity/
                                        = 0.03 mg/kg/day.        RfD\1\ / Special FQPA    carcinogenicity study;
                                                                 SF = 0.03 mg/kg/day.    LOAEL = 30.6 mg/kg/day
                                                                                          for males and 43.1 mg/
                                                                                          kg/day for females
                                                                                          based on decreased
                                                                                          body weight gain,
                                                                                          increased thyroid
                                                                                          weight, and
                                                                                          histopathological
                                                                                          lesions in the liver
                                                                                          and thyroid gland
----------------------------------------------------------------------------------------------------------------
Incidental Oral (all durations)        No NOAEL was             Special FQPA SF is not   No study was selected
                                        identified; UF is not    applicable; no LOC was   because no registered
                                        applicable; no RfD\1\    determined.              uses would result in
                                        was calculated.                                   residential exposure
----------------------------------------------------------------------------------------------------------------

[[Page 55296]]

 
Long-Term Dermal (several months to    Oral study NOAEL= 3 mg/  Residential LOC for      Rat combined chronic
 lifetime)                              kg/day (dermal           MOE\4\ = not             toxicity/
                                        absorption rate =        applicable;.             carcinogenicity study;
                                        4.25%).                 Occupational LOC for     LOAEL = 30.6 mg/kg/day
                                                                 MOE = 100.               for males and 43.1 mg/
                                                                                          kg/day for females
                                                                                          based on decreased
                                                                                          body weight gain,
                                                                                          increased thyroid
                                                                                          weight, and
                                                                                          histopathological
                                                                                          lesions in the liver
                                                                                          and thyroid gland
----------------------------------------------------------------------------------------------------------------
Inhalation (all durations)             Oral study NOAEL= 3 mg/  Residential LOC for      Rat combined chronic
                                        kg/day; Absorption       MOE\4\ = not             toxicity/
                                        factor = 100%).          applicable;.             carcinogenicity study;
                                                                Occupational LOC for     LOAEL = 30.6 mg/kg/day
                                                                 MOE = 100.               for males and 43.1 mg/
                                                                                          kg/day for females
                                                                                          based on decreased
                                                                                          body weight gain,
                                                                                          increased thyroid
                                                                                          weight, and
                                                                                          histopathological
                                                                                          lesions in the liver
                                                                                          and thyroid gland
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)             Classification: Under the 1986 cancer classification scheme,
                                          fenbuconazole was classified as a Group C - Possible Human Carcinogen
                                         with a low dose extrapolation model applied to the animal data for the
                                             quantification of human risk (Q1*). This was based on increased
                                         incidence of hepatocellular adenomas and carcinomas in male and female
                                        mice and of thyroid follicular adenomas and combined adenomas/carcinomas
                                           in male rats. Based on mechanistic data, quantification of risk was
                                           derived using combined hepatocellular adenomas/carcinomas in female
                                          mice. The upper bound estimate of unit risk, Q1* (mg/kg/day)-\1\, is
                                                           3.59 x 10-\3\ in human equivalents.
----------------------------------------------------------------------------------------------------------------
\1\RfD means ``Reference Dose''; \2\aPAD means ``acute Population Adjusted Dose''; \3\cPAD means ``chronic
  Population Adjusted Dose; \4\MOE means ``Margin of Exposure''

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have 
previously been established (40 CFR 180.480) for the combined residues 
of fenbuconazole and its metabolites RH-9129 and RH-9130, in or on a 
variety of raw agricultural commodities. These raw agricultural 
commodities include fat, meat, and meat byproducts of cattle, goat, 
hog, horse, and sheep. Risk assessments were conducted by EPA to assess 
dietary exposures from fenbuconazole 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 one-day or single exposure.
    The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated 
the individual food consumption as reported by respondents in the USDA 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the acute exposure 
assessments: The acute dietary (food plus water) assessment was very 
conservative -- a screening level, Tier 1 assessment. It was based on 
tolerance-level residues and assumed that 100% of each crop was treated 
with fenbuconazole. For water exposure the assessment used the 
estimated maximum peak concentration of fenbuconazole in surface water 
that was calculated from the requested use pattern for cherries, a 
worst-case estimate. The only population subgroup that is relevant for 
this acute assessment is females (13-49 years old).
    ii. Chronic (non-cancer) exposure. In conducting this chronic 
dietary risk assessment the Dietary Exposure Evaluation Model 
(DEEM\TM\) analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: The chronic 
(non-cancer) dietary assessment included contributions from both food 
and water. This analysis is more refined than the acute dietary 
assessment in that it uses average residues from field trials. Due to 
the manner in which these data were submitted and reviewed, multiple 
averages were calculated for many of the crops. For these crops the 
highest average was used in the analysis. The non-cancer chronic 
dietary analysis assumed 100% crop treated and the annual average 
estimated surface water concentration from the cherry use.
    iii. Cancer. The cancer dietary assessment used the same food 
residue inputs as those of the non-cancer assessment--average residues 
from field trials and 100% crop treated for all crops. The water 
component of this assessment used the estimated 30-year average surface 
water concentration from the cherry use.
    iv. Anticipated residue information. Section 408(b)(2)(E) of the 
FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide chemicals that have been measured in food. If EPA 
relies on such information, EPA must, pursuant to section 408(f)(1), 
require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. Following the initial 
data submission, EPA is authorized to require similar data on a time 
frame it deems appropriate. For the present

[[Page 55297]]

action, EPA will issue such data call-ins for information relating to 
anticipated residues as are required by FFDCA section 408(b)(2)(E) and 
authorized under FFDCA section 408(f)(1). Such data call-ins will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances. Anticipated residue data were used in the 
chronic (non-cancer) and cancer dietary risk analyses but not in the 
acute dietary risk analysis. The anticipated residues used were the 
highest per-study-volume average residue from the field trial studies 
for each crop that were submitted by the registrant.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for fenbuconazole in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of fenbuconazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the PRZM/EXAMS and SCI-GROW models, the estimated 
environmental concentrations (EECs) of fenbuconazole for acute 
exposures are estimated to be 20.3 parts per billion (ppb) for surface 
water and 0.031 ppb for ground water. The EECs for chronic (non-cancer) 
and for cancer exposures are estimated to be 16.5 ppb for surface water 
and 0.031 ppb for ground water.
    3. From non-dietary exposure. Where the term ``residential 
exposure'' is used in this document, it refers 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). 
However, fenbuconazole is not registered for any use that will result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Fenbuconazole 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 (EPA, 2002). In conazoles, however, a variable 
pattern of toxicological responses is found. Some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. Some 
induce developmental, reproductive, and neurological effects in 
rodents. Furthermore, the conazoles produce a diverse range of 
biochemical events including altered cholesterol levels, stress 
responses, and altered DNA methylation. It is not clearly understood 
whether these biochemical events are directly connected to their 
toxicological outcomes. Thus, there is currently no evidence to 
indicate that conazoles share common mechanisms of toxicity and EPA is 
not following a cumulative risk approach based on a common mechanism of 
toxicity for the conazoles. For information regarding EPA's procedures 
for cumulating effects from substances found to have a common mechanism 
of toxicity, see EPA's website at http://www.epa.gov/pesticides/cumulative.
    Fenbuconazole is a triazole-derived pesticide. This class of 
compounds can form the common metabolite 1,2,4-triazole and two 
triazole conjugates (triazole alanine and triazole acetic acid). To 
support existing tolerances and to establish new tolerances for 
triazole-derivative pesticides, including fenbuconazole, U.S. EPA 
conducted a human health risk assessment for exposure to 1,2,4-
triazole, triazole alanine, and triazole acetic 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 
Identification (ID) Number EPA-HQ-OPP-2005-0497.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The data provided no 
indication of increased susceptibility of rats or rabbits to in utero 
and/or postnatal exposure to fenbuconazole. In the prenatal 
developmental study in rats and rabbits and the 2-generation study in 
rats, effects in the offspring were observed only at or above those 
treatment levels which resulted in maternal toxicity.
    The degree of concern for infants and children exposed to 
fenbuconazole in utero and/or postnatally is low; there are no residual 
uncertainties. The toxicology database for fenbuconazole is complete 
and adequate for risk assessment purposes. Acceptable developmental 
studies in rats and rabbits and the 2-generation reproduction study in 
rats did not show evidence of increased susceptibility in offspring 
exposed to fenbuconazole in utero and/or postnatally. A NOAEL for acute 
effects has been selected for the subpopulation females (13-49 years 
old) based on developmental effects (increased resorptions and 
decreased live fetuses per dam) seen at the LOAEL in the developmental 
rat study. By regulating on the effect of concern for this 
subpopulation, the risk assessment is protective of potential effects 
to infants and children. No acute effects of fenbuconazole were 
identified in any of the other studies.
    3. Conclusion. There is a complete toxicity data base for 
fenbuconazole and exposure data are complete or are estimated based on 
data that reasonably account for potential exposures. The

[[Page 55298]]

FQPA safety factor was therefore removed (i.e., reduced to 1x) in 
assessing the risk posed by fenbuconazole, based on the following 
considerations:
    i. There are no toxicology data gaps for the assessment of the 
effects of fenbuconazole; a developmental neurotoxicity study is not 
required.
    ii. There is no indication of quantitative or qualitative 
susceptibility of rats or rabbits to in utero and/or postnatal exposure 
to fenbuconazole.
    iii. The dietary exposure assessment is based on models and input 
parameters designed to be protective of human health.
    iv. At this time, there are no registered residential uses for 
fenbuconazole, so this type of exposure to infants and children is not 
expected.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute exposure to fenbuconazole from 
dietary (food plus water) consumption was calculated only for the 
population subgroup females (13-49 years old). It will occupy 3% of the 
aPAD for this subgroup based on a 95\th\ percentile acute dietary 
exposure of 0.009014 mg/kg/day. The surface water concentration that 
was used in this analysis was 20.3 ppb. Because of the toxicology of 
fenbuconazole, an acute risk analysis is not relevant for the general 
U.S. population or any other population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has calculated that chronic dietary 
exposure to fenbuconazole from food plus water will utilize 2% of the 
cPAD for the general U.S. population, 7% of the cPAD for all infants 
(less than 1 year old), and 6% of the cPAD for children (1-2 years 
old). There are no residential uses for fenbuconazole that result in 
chronic residential exposure to fenbuconazole. The surface water 
concentration of fenbuconazole that was used for the general U.S. 
population and each population subgroup in this analysis was 16.5 ppb. 
EPA does not expect the aggregate exposure to exceed 100% of the cPAD 
for the general U.S. population or any subgroup of it, as shown below, 
in Table 2 of this document.

Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to
                              Fenbuconazole
------------------------------------------------------------------------
                                                  Exposure
              Population/Subgroup               (mg/kg/day)     % cPAD
------------------------------------------------------------------------
General U.S. Population                            0.000666            2
------------------------------------------------------------------------
All Infants (>1 Year Old)                          0.002016            7
------------------------------------------------------------------------
Children (1-2 Years Old)                           0.001795            6
------------------------------------------------------------------------
Children (3-5 Years Old)                           0.001408            5
------------------------------------------------------------------------
Children (6-12 Years Old)                          0.000783            3
------------------------------------------------------------------------
Youth (13-19 Years Old)                            0.000419            1
------------------------------------------------------------------------
Adults (20-49 Years Old)                           0.000525            2
------------------------------------------------------------------------
Adults (50+ Years Old)                             0.000612            2
------------------------------------------------------------------------
Females (13-49 Years Old)                          0.000539            2
------------------------------------------------------------------------

    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Fenbuconazole is not registered for use on any site(s) that 
would result in residential exposure. Therefore, the aggregate risks 
are the sums of the risks from food and water, which do not exceed the 
Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Dietary exposure 
(food plus water) is the only source of exposure to fenbuconazole that 
is expected to be chronic (cancer exposure is considered to be life-
time exposure). The chronic (cancer) aggregate exposure and risk 
estimates are based on those for the general U.S. population group. In 
this case the risk is based on a cancer potency (Q1*) value 
of 3.59 x 10-\3\ and a dietary exposure to fenbuconazole of 
0.000666 mg/kg/day. The dietary exposure is the same as that used for 
the chronic (non-cancer) assessment. The estimated cancer risk that 
resulted from this assessment is 2.4 x 10-\6\. In general, 
the precision which can be assumed for cancer risk estimates is best 
described by rounding to the nearest integral order of magnitude on the 
log scale, e.g., 3.16 x 10-\7\ to 3.16 x 10-\6\, 
expressed as 10-\6\. Risks are generally reported to two 
significant figures in Agency risk assessments to allow better 
characterization of changes in risk which might result from potential 
risk mitigation. This rounding procedure indicates that risks should 
generally not be assumed to exceed the benchmark level of concern of 1 
x 10-\6\ until the calculated risks exceed approximately 3 x 
10-\6\. Therefore, the Agency considers this risk estimate 
to be negligible because it falls within the range of 1 in 1 million. 
In addition, the cancer risk estimate for fenbuconazole is over-stated 
due to very conservative exposure assumptions. The exposure estimate 
used in the cancer risk assessment assumes that 100 percent of crops 
covered by tolerances are treated and that all crops contain residues 
at the highest per-study-volume average residue found in crop field 
trials using maximum, or greater than maximum, permitted application 
amounts.
    5. Determination of safety. Based on these risk assessments, EPA 
therefore concludes that there is a reasonable certainty that no harm 
will result to the general population, infants, or children from 
aggregate exposure to fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    Codex MRL's are established on bananas and pecans at 0.05 ppm, 
wheat grain at 0.1 ppm, peach at 0.5 ppm, cherries at 1.0 ppm, and 
wheat straw at 3.0 ppm. Although the residue definitions differ (i.e., 
Codex does not include the metabolites), the U.S. tolerances for pecans 
and wheat grain match the Codex limits numerically. The U.S. stone 
fruit crop group tolerance of 1.0 ppm is consistent with the highest 
Codex MRL on an individual member (cherries) of that crop group. In the 
cases of bananas and wheat straw, the levels of total residues in the 
U.S. tolerance expression (which includes fenbuconazole metabolites) 
are higher than the Codex MRL (which excludes these metabolites). 
Therefore, EPA has not harmonized these values.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
fenbuconazole,

[[Page 55299]]

[alpha]-(2-(4-chlorophenyl)-ethyl)-[alpha]-phenyl-3-(1H-1,2,4-
triazole)-1-propanenitrile and its metabolites cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-furanone and 
trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-
ylmethyl)-2-3H-furanone, expressed as fenbuconazole, in or on almond at 
0.05 ppm; almond, hulls at 1.0 ppm; apple at 0.4 ppm; apple, wet pomace 
at 1.0 ppm; banana at 0.3 ppm; beet, sugar, dried pulp at 1.0 ppm; 
beet, sugar, molasses at 0.4 ppm; beet, sugar, roots at 0.3 ppm; beet, 
sugar, tops at 9.0 ppm; bushberry subgroup 13B at 0.3 ppm; cattle, meat 
byproducts at 0.05 ppm; citrus, dried pulp at 5.0 ppm; citrus, oil at 
40.0 ppm; cranberry at 0.5 ppm; fruit, citrus, group 10 at 1.0 ppm; 
fruit, stone, group 12 at 1.0 ppm; goat, meat byproducts at 0.05 ppm; 
grain, aspirated fractions at 6.0 ppm; grape at 1.0 ppm; horse, meat 
byproducts at 0.05 ppm; peanut at 0.1 ppm; pecan at 0.05 ppm; sheep, 
meat byproducts at 0.05 ppm; wheat, forage at 4.0 ppm; wheat, grain at 
0.1 ppm; wheat, hay at 8.0 ppm; and wheat, straw at 8.0 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerances in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 13, 2006.
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 180.480 is amended in paragraph (a)(1) by revising the table 
and in paragraph (b), in the table, by removing the commodities cattle, 
meat byproducts; goat, meat byproducts; grapefruit; grapefruit, dried 
pulp; grapefruit, oil; horse, meat by products; and sheep, meat 
byproducts.
    The amendment reads as follows:


Sec.  180.480   Fenbuconazole; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Almond...............................................               0.05
Almond, hulls........................................                1.0
Apple................................................                0.4
Apple, wet pomace....................................                1.0

[[Page 55300]]

 
Banana...............................................                0.3
Beet, sugar, dried pulp..............................                1.0
Beet, sugar, molasses................................                0.4
Beet, sugar, roots...................................                0.3
Beet, sugar, tops....................................                9.0
Bushberry subgroup 13B...............................                0.3
Cattle, meat byproducts..............................               0.05
Citrus, dried pulp...................................                5.0
Citrus, oil..........................................               40.0
Cranberry............................................                0.5
Fruit, citrus, group 10..............................                1.0
Fruit, stone, group 12...............................                1.0
Goat, meat byproducts................................               0.05
Grain, aspirated fractions...........................                6.0
Grape\1\.............................................                1.0
Horse, meat byproducts...............................               0.05
Peanut...............................................                0.1
Pecan................................................               0.05
Sheep, meat byproducts...............................               0.05
Wheat, forage........................................                4.0
Wheat, grain.........................................                0.1
Wheat, hay...........................................                8.0
Wheat, straw.........................................                8.0
------------------------------------------------------------------------
\1\There are no United States registrations for grape as of August 2006.

* * * * *
[FR Doc. 06-7957 Filed 9-21-06; 8:45 am]
BILLING CODE 6560-50-S