Fenbuconazole; Pesticide Tolerances, 50556-50563 [E8-19858]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 167 (Wednesday, August 27, 2008)]
[Rules and Regulations]
[Pages 50556-50563]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19858]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0987; FRL-8376-4]


Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of the fungicide fenbuconazole, alpha-[2-(4-

[[Page 50557]]

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)-2-3 H-furanone, and 
RH-9130, trans-5-(4- chlorophenyl)dihydro-3-phenyl-3- (1H-1,2,4-
triazole-1-ylmethyl)-2-3 H- furanone, expressed as fenbuconazole in or 
on pepper (7E7256). The Interregional Research Project Number 4 (IR-4) 
requested this tolerance under the Federal Food, Drug, and Cosmetic Act 
(FFDCA) on behalf of the registrant, Dow AgroSciences LLC.

DATES: This regulation is effective August 27, 2008. Objections and 
requests for hearings must be received on or before October 27, 2008, 
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-2007-0987. To access the 
electronic docket, go to https://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or, 
if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

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

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0987 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before October 27, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0987 by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of January 23, 2008 (73 FR 3964) (FRL-8345-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
7E7256) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. 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 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, expressed as 
fenbuconazole in or on pepper at 0.40 parts per million (ppm). That 
notice referenced a summary of the petition prepared by Dow 
AgroSciences LLC, the registrant, which is available to the public in 
the docket, https://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    In addition, Sec. 180.480(a)(1), is revised to remove reference to 
``time-limited tolerance'' as this section is dedicated to, and only 
contains, permanent

[[Page 50558]]

tolerances. Also, Sec. 180.480(a)(2) is deleted in its entirety as it 
relates solely to time-limited tolerances in paragraph (a)(1) and there 
are no such tolerances in paragraph (a)(1). In addition, the time-
limited tolerance under Sec. 180.480(b) Section 18 emergency 
exemptions, for blueberry at 1.0 ppm that expired on 12/31/07 is 
deleted.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of fenbuconazole on pepper at 0.40 
ppm. EPA's assessment of exposures and risks associated with 
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Fenbuconazole has low acute toxicity and is neither skin or eye 
irritants nor a dermal sensitizer. In subchronic and chronic feeding 
studies the liver was the main target of toxicity. At the LOAEL in the 
subchronic studies, there were changes in liver histopathology, 
predominantly hepatocellular hypertrophy. At doses higher than the 
LOAEL in the rat, the thyroid was a secondary target organ with 
increased follicular cell size. In the chronic studies, liver effects 
were seen (including hepatocellular hypertrophy and vacuolization, 
changes in liver enzymes, and increased liver weights), as well as 
decreased body weight gains. Again, in the chronic rat study, the 
thyroid was a secondary target with increased thyroid and parathyroid 
weights and thyroid follicular cell hypertrophy. In addition, increased 
mean T4 and decreased TSH were found in the high-dose rats near the end 
of the study. In the chronic dog study, kidney and adrenal weights were 
also increased. Males and females throughout the studies appeared to be 
equally sensitive to fenbuconazole toxicity, except in the chronic 
mouse study, where male mice appeared to be more sensitive than the 
females.
    In the rat and rabbit developmental toxicity studies and the two 
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 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. There was no evidence of 
neurotoxicity in any of the studies available in the toxicology 
database.
    Fenbuconazole is not mutagenic. Fenbuconazole is classified as a 
Group C, possible human carcinogen, and febuconazole's human cancer 
risk is assessed quantitatively by a low dose extrapolation model 
applied to the experimental animal tumor data.
    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 https://
www.regulations.gov in document Fenbuconazole (7E7256) - Human Health 
Risk Assessment for the Proposed Use on Peppers at page 14 in docket ID 
number EPA-HQ-OPP-2007-0987-0003.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenbuconazole used for 
human risk assessment can be found at https://www.regulations.gov in 
document Fenbuconazole (7E7256) - Human Health Risk Assessment for the 
Proposed Use on Peppers at page 25 in docket ID number EPA-HQ-OPP-2007-
0987-0003.

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

[[Page 50559]]

existing fenbuconazole tolerances in (40 CFR 180.480). 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.
    In estimating acute dietary exposure, EPA used the Dietary Exposure 
Evaluation Model (DEEM-FCID, Version 2.03), which uses food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intakes by 
Individuals (CSFII). As to residue levels in food, the acute dietary 
exposure analysis is based on tolerance-level residues and 100% crop 
treated assumptions. The only population subgroup that is relevant for 
this acute assessment is females of child-bearing age (i.e., females 
13-49 years old).
    ii. Chronic(non-cancer) exposure. In conducting the chronic dietary 
(food + water) exposure assessment EPA used the food consumption data 
from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, 
the chronic (non-cancer) dietary exposure analyses uses average 
residues from field trials. For many of the crops, separate studies 
were submitted and reviewed. For those crops, multiple averages were 
calculated and the highest average value was used in the analysis. The 
non-cancer dietary analysis assumes 100% crop treated.
    iii. Cancer. The cancer exposure analysis uses average residues 
from field trials. In addition, estimates of average percent crop 
treated were used for certain commodities.
    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.
    Anticipated residue data were used in the chronic (non-cancer) and 
cancer dietary risk analyses but not in the acute dietary risk 
analysis. For many crops, the anticipated residues used were the 
highest per-study-volume average residue value from the field trial 
studies for each crop that were submitted by the registrant.
    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.
    In the cancer dietary exposure analysis, the Agency used the 
following estimated PCT information:
    Apples 1%, apricots 10%, blueberries 40%, cherries 20%, grapefruit 
40%, nectarines 10%, oranges 1%, peaches 15%, pecans 15%, prunes 1%, 
and 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 years. 
EPA uses an average PCT for chronic dietary risk analysis. The average 
PCT figure for each existing use is derived by combining available 
public and private market survey data for that use, averaging across 
all observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in the 
preceding paragraphs have been met. With respect to Condition a, PCT 
estimates are derived from sources as discussed in the preceding 
paragraphs including Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which fenbuconazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models to determine the drinking water 
concentrations that were used in the dietary exposure analysis and risk 
assessment for fenbuconazole. 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 https://
www.epa.gov/oppefed1/models/water/index.htm.
    The assessments included conservative estimated drinking water 
concentrations (EDWC) based on either the pepper or the cherry use. 
Modeled surface water EDWCs are based on the maximum label application 
rate to peppers (acute value) or cherries (chronic and cancer values) 
while the groundwater EDWC is based on the maximum label application 
rate to cherries. The acute assessment is highly conservative with 
respect to evaluating potential impacts of dietary exposure to 
fenbuconazole on human health. The chronic (non-cancer) and cancer 
assessments are moderately conservative with respect to evaluating 
potential impacts of dietary exposure to fenbuconazole on human health.
    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

[[Page 50560]]

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. The EDWCs for chronic exposures for non-
cancer assessments are estimated to be 16.5 ppb for surface water and 
0.031 ppb for ground water. The EDWCs for chronic exposures for cancer 
assessments are estimated to be 11.7 ppb for surface water and 0.031 
ppb for ground 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 plants (fungi) by 
inhibiting ergosterol biosynthesis, there is not necessarily a 
relationship between their pesticidal activity and their mechanism of 
toxicity in mammals. Structural similarities do not constitute a common 
mechanism of toxicity. Evidence is needed to establish that the 
chemicals operate by the same, or essentially the same, sequence of 
major biochemical events. In conazoles, however, a variable pattern of 
toxicological responses is found. Some are hepatotoxic and 
hepatocarcinogenic in mice. Some induce thyroid tumors in rats. 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, refer to EPA's website at https://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 https://www.regulations.gov, docket ID number 
EPA-HQ-OPP-2005-0497. Additional information regarding the use proposed 
for fenbuconazole in this action can also be found at https://
www.regulations.gov in document: ``Dietary Exposure Assessments for the 
Common Triazole Metabolites 1,2,4-Triazole, Triazolylalanine, 
Triazolylacetic Acid, and Triazolylypyruvic Acid; Updated to Include 
New Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and 
Uniconazole; and a Change in Plant-back Restriction for Tetraconazole'' 
in docket ID number EPA-HQ-OPP-2007-0987-0006.

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 
factor.
    2. Prenatal and postnatal sensitivity. Available 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 effects of concern for this 
subpopulation, the risk assessment is protective of potential effects 
to infants and children.
    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. EPA has 
determined that reliable data show the safety of infants and children 
would be adequately protected if the FQPA SF were reduced to 1X. That 
decision is based on the following findings:
    i. The toxicity database for fenbuconazole is complete.
    ii. There is no indication that fenbuconazole is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenbuconazole results in increased 
susceptibility in utero to rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study
    iv. There are no residual uncertainties identified in the exposure 
databases. Although somewhat refined, the dietary food exposure 
assessments were based on reliable data that will not underestimate 
exposure to fenbuconazole residues in food. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure

[[Page 50561]]

to fenbuconazole in drinking water. 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenbuconazole will occupy 3.1 % of the aPAD for females 13-49 years 
old, the only subgroup of concern because of the toxicological 
properties of fenbuconazole.
    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 6.8% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure, and 2.3% of the cPAD for the general U.S. 
population. There are no residential uses for fenbuconazole that result 
in chronic exposure. EPA does not expect aggregate exposure to exceed 
100% of the cPAD for any population subgroup.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate exposures take into account short-term residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level). Fenbuconazole is not registered for any use patterns 
that would result in residential exposure. Therefore, the aggregate 
risk is the sum of the risk from exposure to fenbuconazole through food 
and water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Dietary exposure 
(food + 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 0.000473 
mg/kg/day. The estimated cancer risk that resulted from this assessment 
is 1.7 x 10-\6\. Typically, EPA is concerned when the cancer 
risk estimate associated with food and drinking water exceeds the range 
of 1 in 1 million (1 x 10-\6\) . This risk range includes 
computed risks as high as 3 x 10-\6\. As a result, cancer 
risk to the general U.S. population is below the Agency's level of 
concern.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to 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: 
residuemethods@epa.gov.

B. International Residue Limits

    Maximum Residue Levels (MRLs) for residues of fenbuconazole have 
been established by Codex, Canada, and Mexico. The residue definition 
for both Codex and Mexico is fenbuconazole, per se. The Canadian 
residue definition, however, is the combined residues of fenbuconazole 
and its metabolites, RH-9129 and RH-9130, each expressed as parent 
(i.e., the same as the U.S. tolerance definition). There are no 
established or proposed Canadian, Mexican, or Codex MRLs for 
fenbuconazole on pepper.

C. Revisions to Petitioned-For Tolerances

    By this action, Sec. 180.480(a)(1), is revised to remove reference 
to ``time-limited tolerance'' as this section is dedicated to, and only 
contains, permanent tolerances. Also, Sec. 180.480(a)(2) is deleted in 
its entirety as it relates solely to time-limited tolerances in 
paragraph (a)(1) and there are no such tolerances in paragraph (a)(1). 
In addition, the time-limited tolerance under Sec. 180.480(b), section 
18 emergency exemptions, for blueberry at 1.0 ppm that expired on 12/
31/07 is deleted.

V. Conclusion

    Therefore, tolerances are established 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 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, expressed as fenbuconazole in or on pepper at 0.40 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, Actions Concerning Regulations 
That Significantly Affect Energy Supply, Distribution, or Use (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special 
considerations under Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments,

[[Page 50562]]

on the relationship between the national government and the States or 
tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 9, 
2000) do not apply to this final rule. In addition, this final rule 
does not impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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


    Dated: August 15, 2008.
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 by removing paragraph (a)(2); 
redesignating paragraph (a)(1) as paragraph (a); revising the 
introductory text in paragraph (a); adding alphabetically a commodity 
to the table in paragraph (a); and revising paragraph (b) to read as 
follows:


Sec.  180.480  Fenbuconazole; tolerances for residues.

    (a) General. Tolerances are established 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 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, expressed as fenbuconazole in or on the following 
agricultural commodities.

----------------------------------------------------------------------------------------------------------------
                       Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
                                                    * * * * *
Pepper                                                                                                      0.40
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for fenbuconazole (alpha-[2-4-chlorophenyl)-ethyl]alpha-
phenyl-3-(1 H -1,2,4-triazole)-1-propanenitrile] and its metabolites, 
cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1 H -1,2,4-triazole-1-
ylmethyl)-2-3 H -furanone and trans-5-(4-chlorophenyl)dihydro-3-phenyl-
3-(1 H 1,2,4-triazole-1-ylmethyl-2-3 H -furanone, expressed as 
fenbuconazole in or on the following raw agricultural commodities in 
connection with use of the pesticide under a section 18 exemption 
granted by EPA. The time-limited tolerances will expire on the date 
specified in the following table.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                           Commodity                                      Parts per million                       Expiration/revocation date
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle, fat                                                                                    0.01                                             12/31/08
Cattle, meat                                                                                   0.01                                             12/31/08
Goat, fat                                                                                      0.01                                             12/31/08
Goat, meat                                                                                     0.01                                             12/31/08
Hog, fat                                                                                       0.01                                             12/31/08
Hog, meat byproducts                                                                           0.01                                             12/31/08
Hog, meat                                                                                      0.01                                             12/31/08
Horse, fat                                                                                     0.01                                             12/31/08
Horse, meat                                                                                    0.01                                             12/31/08
Sheep, fat                                                                                     0.01                                             12/31/08
Sheep, meat                                                                                    0.01                                             12/31/08
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 50563]]

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[FR Doc. E8-19858 Filed 8-26-08; 8:45 am]
BILLING CODE 6560-50-S