[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 40020-40027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-15867]



40 CFR Part 180

 [EPA-HQ-OPP-2012-0520; FRL-9390-5]

Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
fenbuconazole in or on pepper. Dow AgroSciences LLC requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 3, 2013. Objections and 
requests for hearings must be received on or before September 3, 2013, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

[[Page 40021]]

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0520, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Erin Malone, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0253; email address: malone.erin@epa.gov.


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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2012-0520 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 3, 2013. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0520, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2F8034) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, 
Indiana 46268. The petition requested that 40 CFR 180.480 be amended by 
modifying the tolerance for residues of the fungicide fenbuconazole, 
propanenitrile, and its metabolites RH-9129, cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, and 
RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3 H-furanone, in or on pepper from 0.4 parts per 
million (ppm) to 1.0 ppm. That document referenced a summary of the 
petition prepared by Dow AgroSciences LLC, the registrant, which is 
available in the docket, http://www.regulations.gov. A comment was 
received on the notice of filing. EPA's response to this comment is 
discussed 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fenbuconazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenbuconazole 

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The main target organ of fenbuconazole is the liver. 
Increased liver weight, hepatocellular hypertrophy, and clinical 
chemistry changes were observed in the rat, dog,

[[Page 40022]]

and mouse following subchronic and chronic exposure. In the rat (but 
not the dog or mouse), effects on the thyroid were also observed. A 
mechanistic study demonstrated that these findings are secondary to 
changes in liver metabolic enzyme activities, which result in 
alterations to levels of circulating thyroid hormone due to increased 
clearance via increased liver metabolism and, eventually, thyroid 
hyperplasia. The rat is significantly more sensitive to these effects 
than other species. Clear NOAELs and LOAELs were established for these 
findings, and the endpoints selected for human health risk assessment 
are protective of the thyroid effects. The endpoints are also 
protective of potential thyroid perturbation to offspring, as the 
developmental NOAELs were significantly higher than the NOAELs for 
thyroid and liver effects in adults (e.g., chronic dietary endpoint 
based on rat chronic/carcinogenicity NOAEL of 3 mg/kg/day vs. rat 
developmental NOAEL of 30 mg/kg/day), and no increased quantitative 
susceptibility was observed for thyroid and liver effects among the 
offspring relative to the parental animals. Kidney and adrenal weights 
were increased in dogs after chronic exposure. Although acute and 
subchronic neurotoxicity have not been submitted, EPA concluded that 
these studies are not required, taking into consideration the lack of 
observed neurotoxic effects in the available studies for fenbuconazole 
as well as many other triazole fungicides. There was no evidence of 
increased quantitative or qualitative susceptibility to in utero or 
post-natal exposure to fenbuconazole. Since the previous assessment, 
new rabbit developmental toxicity and rat metabolism studies were 
submitted; the findings of these studies are consistent with the data 
EPA assessed previously and do not affect the overall characterization 
of hazard or selection of doses and endpoints for risk assessment. 
Fenbuconazole is classified as a ``Group C,'' or possible human 
carcinogen, based on an increased incidence of liver tumors in male and 
female mice. A cancer potency factor has been used to quantify 
potential cancer risk associated with fenbuconazole uses.
    Specific information on the studies received and the nature of the 
adverse 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 in document ``Fenbuconazole: Human Health Risk 
Assessment for an Increased Tolerance for Residues in Peppers and a 
Label Amendment for the Enable 2F Product'' at page 14 in docket ID 
number EPA-HQ-OPP-2012-0520.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 fenbuconazole used for human risk assessment is shown in 
Table 1 of this unit.
    A summary of the toxicological endpoints for fenbuconazole used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fenbuconazole for Use in Human Health Risk Assessment
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
Acute dietary (Females 13-49       NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Developmental rat study
 years of age).                    UFA = 10x...........   kg/day.             LOAEL = 75 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3mg/kg/day   increased resorptions,
                                   FQPA SF = 1x........                        postimplantation loss and
                                                                               decreased live fetuses per dam.
Acute dietary (General population  None................  None...............  Not selected
 including infants and children).                                             No appropriate single dose and
                                                                               endpoint could be identified for
                                                                               these population groups.
Chronic dietary (All populations)  NOAEL = 3 mg/kg/day.  Chronic RfD = 0.03   Combined chronic toxicity/
                                   UFA = 10x...........   mg/kg/day.           carcinogenicity--Rat
                                   UFH = 10x...........  cPAD = 0.03 mg/kg/   LOAEL = 30.6/43.1 (M/F) mg/kg/day
                                   FQPA SF = 1x........   day.                 based on decreased body weight
                                                                               gain, increased thyroid weight,
                                                                               and hispathological lesions in
                                                                               the liver and thyroid gland.

[[Page 40023]]

Cancer (Oral, dermal, inhalation)  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
                                    classification was based on a statistically significant increase in combined
                                    hepatocellular adenomas and/or carcinomas by pair-wise comparison with
                                    concurrent controls, and significantly increasing trend in both the
                                    incidences of adenomas, and combined adenomas/carcinomas, in female mice.
                                    The upper bound estimate of unit risk, Q1* (mg/kg/day)-1 is 3.59 x -3 in
                                    human equivalents.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligrams/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute,
  c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenbuconazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenbuconazole 
tolerances in 40 CFR 180.480. For the acute, chronic, and cancer 
dietary exposure assessments, EPA used food consumption information 
from the United States Department of Agriculture's (USDA) National 
Health and Nutrition Examination Survey/What We Eat In America (NHANES/
WWEIA) collected from 2003-2008. In addition, EPA assessed 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 1-day or single exposure.
    Such effects were identified for fenbuconazole only for females age 
13-49. As to residue levels in food, EPA used tolerance-level residues 
and assumed 100% crop treated for all commodities in the acute dietary 
exposure assessment.
    ii. Chronic exposure. As to residue levels in food, EPA used a 
combination of tolerance-level residues and, for many foods, average 
residue levels from crop field trials. One-hundred percent crop treated 
was assumed for all commodities in the chronic dietary exposure 
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. Based on the data summarized in Unit III.A., EPA has 
concluded that fenbuconazole should be classified as ``Possibly 
Carcinogenic to Humans'' and a linear approach has been used to 
quantify cancer risk.
    In its assessment of dietary cancer risk, EPA used the same residue 
levels as described for the chronic assessment. EPA also assumed 100% 
crop treated, except for the percent crop treated estimates described 
in Unit III.C.1.iv., below.
    iv. Anticipated residue and percent crop treated (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 FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows for the 
cancer assessment: Almonds: 5%; apples: 5%; apricots: 5%; blueberries: 
55%; cherries: 15%; grapefruit: 40%; nectarines: 5%; oranges: 5%; 
peaches: 15%; pecans: 10%; plums/prunes: 1%; sugar beets: 1%; tangelos: 
10%; tangerines: 1%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
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 

[[Page 40024]]

for the existing use and rounded up to the nearest multiple of 5%.
    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 
are 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 fenbuconazole 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 fenbuconazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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 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 
fenbuconazole for acute exposures are estimated to be 24.1 parts per 
billion (ppb) for surface water and 0.031 ppb for ground water, for 
chronic exposures for non-cancer assessments are estimated to be 16.5 
ppb for surface water and 0.031 ppb for ground water, and for chronic 
exposures for cancer assessments are estimated to be 11.7 ppb for 
surface water and 0.031 ppb for ground 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 24.1 ppb was used to 
assess the contribution from drinking water. For chronic dietary risk 
assessment, the water concentration of value 16.5 ppb was used to 
assess the contribution from drinking water. For cancer dietary risk 
assessment, the water concentration of value 11.7 ppb was used to 
assess the contribution from 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). Fenbuconazole is not 
registered for any specific use patterns that would result in 
residential 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.''
    Fenbuconazole is a member of the triazole-containing class of 
pesticides. Although conazoles act similarly in 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 conazoles 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 Web site 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 as well as the 
common triazole conjugates (triazolylalanine, triazolylacetic acid, and 
triazolylpyrivic acid). To support existing tolerances and to establish 
new tolerances for triazole-derivative pesticides, including 
fenbuconazole, EPA conducted human health risk assessments for exposure 
to 1,2,4-triazole and the common triazole conjugates 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). 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-
    Aggregate risk from exposure to the common triazole metabolites 
were recently estimated by the Agency (1 May 2013) and found to be not 
of concern. An updated dietary exposure and risk analysis for the 
common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA), 
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP), reflecting 
the revised tolerance for residues of fenbuconazole in/on pepper was 
completed on May 21, 2013. Given that the updated dietary risk estimate 
increased by less than 1% relative to the previous assessment, new 
aggregate risk estimates were not made, and aggregate risk estimates 
for the common triazole metabolites remain below the Agency's level of 
concern. These documents may be found on http://www.regulations.gov by 
searching for the following titles and docket numbers: ``Common 
Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to 
Address The New Section 3 Registrations For Use of Prothioconazole on 
Bushberry Crop Subgroup 13-07B, Low Growing Berry, Except Strawberry, 
Crop Subgroup 13-07H, and Cucurbit Vegetables Crop Group 9; Use of 
Flutriafol on Coffee; and Ipconazole on Crop Group 6'' (located in 
docket ID number EPA-HQ-OPP-2012-0876) and ``Common Triazole 
Metabolites: Updated Dietary (Food + Water) Exposure and Risk 
Assessment to Address the Revised

[[Page 40025]]

Tolerance for Residues of Fenbuconazole in Peppers'' (docket ID number 

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 Safety 
Factor (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 
    2. Prenatal and postnatal sensitivity. In the rat and rabbit 
developmental toxicity studies and the 2-generation study in rats, all 
effects in the pups occurred in the presence of maternal toxicity, 
including changes in body weight and body weight gains in rats and 
decreased food consumption and clinical signs in rabbits. Developmental 
effects included increased post-implantation loss and decreased live 
fetuses per dam in the rat developmental study; increased early 
resorptions in the rabbit developmental study; and decreased mean pup 
body weight, increased number of stillborn pups, decreased number of 
total offspring delivered, and decreased viability index of pups in the 
two generation study in rats. No increased qualitative or quantitative 
susceptibility was observed in any of the studies. In the rat 
developmental toxicity study, although a decrease in the number of live 
fetuses per litter was observed at the LOAEL, this effect was due 
largely to reduced implantation sites, which may reflect maternal 
toxicity. Additionally, the increases in postimplantation loss and 
early resorptions were marginal at the LOAEL. Therefore, the findings 
in this study were not considered indicative of increased offspring 
susceptibility. In the rabbit developmental study, developmental 
effects were observed at a higher dose than maternal effects. In the 
rat reproduction study, effects on pup viability were observed at a 
dose that resulted in maternal mortality during delivery. There was no 
evidence of neurotoxicity in any of the studies available in the 
toxicology database. Therefore, a developmental neurotoxicity study is 
not required.
    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 
    i. The toxicity database is complete, except for an immunotoxicity 
study; however, due to the lack of any evidence of immunotoxicity based 
upon the available studies, EPA does not believe that an immunotoxicity 
study will result in a lower point-of-departure than those being relied 
upon for the present risk assessments. Therefore, an uncertainty factor 
is not required to account for the lack of this study.
    ii. There is no evidence of neurotoxicity in the available 
database, and a developmental neurotoxicity study is not required.
    iii. There is no evidence that fenbuconazole results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary exposure assessment is a screening-level 
assessment, utilizing tolerance-level residues and assuming 100% crop 
treated. The chronic dietary exposure assessment is slightly refined, 
utilizing some tolerance-level residues and some average residue levels 
from crop field trials and assuming 100% crop treated. The cancer 
dietary exposure assessment is also slightly refined, utilizing the 
same residue estimates as for the chronic assessment and some percent 
crop treated estimates. EPA made conservative (protective) assumptions 
in the ground water and surface water modeling used to assess exposure 
to fenbuconazole in drinking water. There are no registered residential 
uses for fenbuconazole. These assessments will not underestimate the 
exposure and risks posed by fenbuconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. The only population subgroup that is relevant for an 
acute assessment is females of child-bearing age (i.e., females 13-49 
years old). The acute risk estimate that results from this analysis is 
2.9% of the acute population adjusted dose (aPAD) at the 95th 
percentile of exposure. This risk estimate is considerably lower than 
EPA's level of concern (100% of the aPAD).
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenbuconazole from food and water will utilize 6.7% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for fenbuconazole.
    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). For 
fenbuconazole, there are no residential uses and therefore a short-term 
aggregate risk assessment was not needed.
    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). There are no residential uses for fenbuconazole at this time, 
therefore an intermediate-term risk assessment was not needed.
    5. Aggregate cancer risk for U.S. population. Fenbuconazole is 
classified as a Group C (possible human) carcinogen under the Agency's 
1986 Cancer Guidelines, based on increased incidences of liver tumors 
in male and female mice and thyroid tumors in male rats. Using the 
conservative exposure assumptions described in this unit for cancer 
risk from chronic exposure and an upper bound estimate of unit risk 
(Q1*) of 3.59 x 10-3 (mg/kg/day)-1, 
EPA has derived a cancer risk estimate of 2.2 x 10-6 from 
dietary exposure to fenbuconazole.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
10-6) or less to be negligible. The precision which can be 
assumed for cancer risk estimates is best described by rounding to the 
nearest integral order of magnitude on the logarithmic scale; for 
example, risks falling between 3 x 10-7 and 3 x 
10-6 are expressed as risks in the range of 10-6. 
Considering the precision with

[[Page 40026]]

which cancer hazard can be estimated, the conservativeness of low-dose 
linear extrapolation, and the rounding procedure described in this 
unit, cancer risk should generally not be assumed to exceed the 
benchmark level of concern of the range of 10-6 until the 
calculated risk exceeds approximately 3 x 10-6. This is 
particularly the case where some conservatism is maintained in the 
exposure assessment. Although the fenbuconazole exposure risk 
assessment is somewhat refined, it retains significant conservatism in 
that the analysis relies on field trial data and assumes 100% crop 
treated for many commodities. Accordingly, EPA has concluded the 
aggregate cancer risk for all existing fenbuconazole uses and the uses 
associated with the tolerances established in this action fall within 
the range of 1 x 10-6 and are thus negligible.
    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 fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GC/NPD method, TR 34-940-47 and 
TR34-90-47R) 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; email address: 

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established an MRL for fenbuconazole in or on pepper 
at 0.6 ppm. This MRL is different than the tolerance established for 
fenbuconazole in the United States. The Codex MRL for pepper was most 
likely established before the Enable[supreg] 2F formulation was 
proposed for use on peppers and includes only residues of the parent 
compound. This new formulation has higher residues values ranging up to 
0.7 ppm, and the U.S. tolerance includes the two lactone metabolites. 
Harmonization with the 0.6 ppm tolerance is not feasible given the 
proposed new use pattern/formulation and the observed residue levels.

C. Response to Comments

    EPA received a comment to the notice of filing which said that 
residue levels of fenbuconazole should not be raised. The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
corps. However, the existing legal framework provided by section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. This citizen's comment appears to be directed at the 
underlying statute and not EPA's implementation of it; the citizen has 
made no contention that EPA has acted in violation of the statutory 

V. Conclusion

    Therefore, tolerances are modified to establish residues of 
fenbuconazole in or on pepper at 1.0 ppm. Consistent with the petition 
and EPA's policy for clarifying its tolerance expressions, EPA is 
revising the tolerance expression for fenbuconazole to clarify that the 
tolerance includes metabolites and degradates of fenbuconazole and that 
compliance with the tolerance levels specified in the table is to be 
determined by measuring only the sum of fenbuconazole, alpha-[2-(4-
propanenitrile, and its metabolites RH-;9129, cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, and 
RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3 H-furanone, calculated as the stoichiometric 
equivalent of fenbuconazole,

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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

[[Page 40027]]

as described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: June 21, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.480 revise paragraph (a) introductory text and revise 
the entry ``Pepper'' in the table in paragraph (a) to read as follows:

Sec.  180.480  Fenbuconazole; tolerances for residues.

    (a) Tolerances are established for residues of the fungicide 
fenbuconazole, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
fenbuconazole, alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-5-
H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, calculated as the 
stoichiometric equivalent of fenbuconazole, in or on the following 
agricultural commodities.

                                                             Parts per
                        Commodity                             million
                                * * * * *
Pepper..................................................             1.0
                                * * * * *

* * * * *
[FR Doc. 2013-15867 Filed 7-2-13; 8:45 am]