[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Rules and Regulations]
[Page 50556-50563]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au08-5]
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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 http://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 http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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 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 EPA's tolerance regulations at
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 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: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket'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, http://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 http://
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 http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for fenbuconazole used for
human risk assessment can be found at http://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 http://
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 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 ID number
EPA-HQ-OPP-2005-0497. Additional information regarding the use proposed
for fenbuconazole in this action can also be found at http://
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]]
* * * * *
[FR Doc. E8-19858 Filed 8-26-08; 8:45 am]
BILLING CODE 6560-50-S