[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Rules and Regulations]
[Page 32841-32846]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn06-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0297; FRL-8061-4]
Fenarimol; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
fenarimol in or on filbert. Interregional Research Project Number 4
(IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA). Fenarimol was reassessed and approved by the Agency
effective August 1, 2002. To view the Tolerance Reassessment Progress
and Risk Management Decision (TRED) and related supporting documents,
please refer to docket number (EPA-HQ-OPP-2002-0250-0001) at
http://www.regulations.gov.
DATES: This regulation is effective June 7, 2006. Objections and
requests for hearings must be received on or before August 7, 2006, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0297. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed underFOR 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 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0297 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before August 7, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0297, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of August 31, 2005 (70 FR 51802) (FRL-7733-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a
[[Page 32842]]
pesticide petition (PP 5E4573) by IR-4, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.421 be
amended by establishing a tolerance for residues of the fungicide
fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-
pyrimidinemethanol] in or on filbert at 0.02 parts per million (ppm).
That notice included a summary of the petition prepared by Gowan
Company, the registrant. There were no comments received in response to
the notice of filing.
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 * *
*.''
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of fenarimol on
filbert at 0.02 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by fenarimol 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.epa.gov/EPA-PEST/2002/December/Day-04/p30471.htm
.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.
A summary of the toxicological endpoints for fenarimol used for
human risk assessment is shown in Table 1 of this unit:
Table 1.-- Summary of Toxicological Dose and Endpoints for Fenarimol for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (Females 13-50 years NA NA Rat Developmental and
ofage) Multi-generation
Reproductive
ToxicityStudy
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population NA NA No appropriate endpoint
including infants and children) was available to
quantitate risk.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 0.6 mg/kg/day Special FQPA SF = 3X Multi-generation
UF = 100 X............. cPAD = chronic RfD/ Reproduction Study
Chronic RfD = 0.006 mg/ Special FQPA SF = LOAEL = 1.2 mg/kg/day
kg/day. 0.002 mg/kg/day. based on decreased
live born litter size
in the F1 and F2
generations.
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral, Dermal, Dermal/oral study LOAEL LOC for MOE = 900 Special Reproduction
andInhalation (1 to 30 days) = 35 mg/kg/day (Residential).......... Study
(Residential)........................ FQPA factor = 3X UF= LOAEL = 35 mg/kg/day
300. based on decreased
fertilityand dystocia,
an indicator of
hormonal effects,
observed in aspecial
non-guideline cross
breeding reproduction/
developmentaltoxicity
study in rats
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Incidental Oral, Dermal/oral study NOAEL LOC for MOE = 100 Multi-generation
Dermal, and Inhalation (1- 6 months) = 0.6 mg/kg/day (Residential).......... Reproduction Study
(Residential)........................ FQPA factor = 3X....... LOAEL = 0.6 mg/kg/day
based on decreased
live born litter size
in the F1 and F2
generations
----------------------------------------------------------------------------------------------------------------
[[Page 32843]]
Cancer (oral, dermal, inhalation) NA NA Fenarimol has been
classified as a ``not
likely'' human
carcinogen (Group E).
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.421)(a)(1) for the residues of fenarimol,
[alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol]
for the following raw agricultural commodities (RACs): Apple at 0.1;
apple, dry pomace at 2.0; apple, wet pomace at 2.0; cattle, fat at 0.1;
cattle, kidney at 0.1; cattle, meat at 0.01; cattle, meat byproducts,
except kidney at 0.05; goat, fat at 0.1; goat, kidney at 0.1; goat,
meat at 0.01; goat, meat byproducts, except kidney at 0.05; horse, fat
at 0.1; horse, kidney at 0.1; horse, meat at 0.01; horse, meat
byproducts, except kidney at 0.05; pear at 0.1; pecan at 0.1; sheep,
fat at 0.1; sheep, kidney at 0.1; sheep, meat at 0.01; and sheep, meat
byproducts, except kidney at 0.05.
Tolerances have also been established (40 CFR 180.421)(a)(2) for
the combined residues of fenarimol [alpha-(2-chlorophenyl)-alpha-(4-
chlorophenyl)-5-pyrimidinemethanol] and its metabolites [alpha-(2-
chlorophenyl)-alpha-(4-chlorophenyl)-1,4-dihydro-5-pyrimidinemethanol
and 5-[(2-chlorophenyl) (4-chlorophenyl)methyl]-3,4-dihydro-4-
pyrimidinol measured as the total of fenarimol and 5-[(2-chlorophenyl)-
(4-chlorophenyl)methyl]pyrimidine (calculated as fenarimol) for the
following RACs: Banana (import) at 0.5; cherry at 1.0; grape, juice at
0.6; grape pomace (wet and dry) at 2.0; grape at 0.2; grape, raisin,
waste at 3.0; grape, raisin at 0.6. Risk assessments were conducted by
EPA to assess dietary exposures from fenarimol 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. No such effects were
identified in the toxicological studies for fenarimol, therefore a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. The chronic dietary exposure assessment for
fenarimol is highly refined using anticipated residues based on 1996-
1999 Food and Drug Administration (FDA) monitoring data for apples,
bananas, cherries, grapes and pears. Field trial residue data were used
for pecans and filberts. Percent crop treated (%CT) information and
processing factors, where available, were used in the assessment. There
were no PDP monitoring data available for fenarimol.
iii. 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 chemicals
that have been measured in food. If EPA relies on such information, EPA
must pursuant to section 408(f)(1) require that data be provided 5
years after the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. For the
present action, EPA will issue such Data Call-Ins for information
relating to anticipated residues as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data
Call-Ins will be required to be submitted no later than 5 years from
the date of issuance of this tolerance.
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 the Agency can make the following findings: Condition 1,
that 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 such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if 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 section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows:
Almonds 0.1%; apples 25%; bananas < 1%; cherries, sweet 13%;
cherries, tart 9%; grapes, raisin 21%; grapes, table 8%; grapes wine
9%; hazelnuts 9%; pecans 1%; and pears 10%. These PCT figures were
derived from a quantitative usage analysis (QUA) for fenarimol by the
Agency based on data years 1990-1999. The weighted average of percent
crop treated (%CT) was used for estimating chronic dietary exposure.
Additional information on imported bananas was obtained indicating that
less than 1% of bananas consumed in the United States are treated with
fenarimol. For pecans, a default 1% crop treated was assumed (0% CT
reported in QUA).
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, 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 2 and 3, 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
information on the regional consumption of food to which fenarimol may
be applied in a particular area.
[[Page 32844]]
iv. Cancer. Fenarimol has been classified as a ``not likely'' human
carcinogen (Group E) and thus a quantitative exposure assessment as to
cancer risk is unnecessary.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fenarimol in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of fenarimol.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Groundwater models, the estimated
environmental concentrations (EECs) of fenarimol chronic exposures are
estimated to be 26 ppb for surface water and 16 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).
Fenarimol is not registered for use on any sites that would result
in exposure in or around the home. Fenarimol is registered for use on
turf however,. Applications to turf are limited to golf courses, and
stadium fields or professional athletic fields only. Therefore, the
Agency has determined that the only potential non-occupational
postapplication exposure is short-term dermal exposure to adult
golfers.
EPA's ``Standard Operating Procedures (SOPs) for Residential
Exposure Assessments'' at (http://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-04/o-p34736.htm
) were used to estimate the exposures of
adult golfers contacting treated turf. The SOPs for turf use transfer
coefficients based on mowing studies. Chemical specific data from a
turf transferable residue (TTR) study were available; however, these
TTR data were unacceptable for use in postapplication exposure
assessment. Therefore, default assumptions from the SOPs were used.
Exposures were estimated for short-term dermal contact with treated
turf during the low contact activity of golfing. The exposure estimates
generated for the golfing turf use is based on some upper-percentile
assumptions (i.e., duration of exposure and maximum application rate
for this short-term assessment) and is considered to be representative
of high end exposures. The uncertainties associated with this
assessment stem from the use of an assumed amount of pesticide retained
on turf, and assumptions regarding the transfer of fenarimol residues.
The turf risk estimate is believed to be a reasonable and protective
estimate. Therefore, the level of confidence is fairly high, and does
not under estimate risk.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fenarimol and any other
substances and fenarimol does not appear to produce a toxic metabolite
produced by other substances. EPA has also evaluated comments submitted
that suggested there might be a common mechanism among fenarimol and
other named pesticides that cause brain effects. EPA concluded that the
evidence did not support a finding of common mechanism for fenarimol
and the named pesticides. For the purposes of this tolerance action,
therefore, EPA has not assumed that fenarimol has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. The developmental and
reproductive toxicity studies showed no evidence of increased
sensitivity or susceptibility of young rats or rabbits following
prenatal or postnatal exposure to fenarimol. However, the studies
demonstrated that fenarimol is associated with hydronephrosis that is
reversible.
3. Conclusion. The data base for prenatal developmental and
reproductive toxicity is considered complete. Based upon the RED
completed June 2002, the Agency reduced the FQPA Safety factor from 10X
to 3X. It was determined that the 3X would be retained until a special
developmental toxicity study was received and reviewed to confirm if
the potential hormonal effects elicited by inhibition of aromatase
would result in effects in the rat pups. However more recently,
fenarimol has been evaluated in studies considered in EPA's Endocrine
Disruptor Screening Program including the Pubertal Female and
Uterotrophic Assays. The Pubertal Female Assay involves the use of rats
to screen for estrogenic and thyroid activity in females during sexual
maturation, and examines abnormalities associated with sex organs and
puberty markers, as well as thyroid tissue. The Uterotrophic assay
involves the use of female rats to screen for estrogenic effects. In
this in vivo assay, uterine weight changes are measured in
ovariectomised or immature female rats.
No adverse effects were found in the female pubertal assay when SD
rats were treated at 50 and 250 milligram/kilogram (mg/kg) day for 21
days, except for a decrease in T4 and an increase in circulating TSH
levels. In the Uterotrophic assay, a dose of 200 mg/kg day results in a
significant increase of uterine weights which were accompanied by an
increase in serum FSH levels and a decrease in serum T3 levels. The
uterotrophic response and the effects found on thyroid hormone levels
are found at much higher doses than the regulatory endpoints based on
the rat multi-generation study where fenarimol reduced fertility of
males at 1.2 mg/kg per day with a NOAEL of 0.6 mg/kg per day. The 0.6
mg/kg NOAEL
[[Page 32845]]
is over 300-fold lower than the uterotrophic response found in rats at
200 mg/kg.
In conclusion, there is greater confidence in the current NOAEL of
0.6 mg/kg per day given these recent studies on the reproductive,
developmental and endocrine effects of fenarimol. It is therefore
recommended that the 3X FQPA safety factor be removed because there are
adequate data evaluating the potential endocrine effects of fenarimol
during development and in the young animal. As a result, the Agency no
longer requires a special developmental study.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No acute risk is expected from exposure to fenarimol
since no acute endpoints were identified for the general U.S.
population (including infants and children) or the females 13-50 years
old population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fenarimol
from food will utilize < 1% of the cPAD for the U.S. population, < 1% of
the cPAD for all infants < 1 year old, and < 1% of the cPAD for children
1-6 years old. There are no residential uses for fenarimol that result
in chronic residential exposure to fenarimol. In addition, there is
potential for chronic dietary exposure to fenarimol in drinking water.
After calculating Drinking Water Level of Comparison (DWLOCs) and
comparing them to the EECs for surface water and ground water, infants
and children, the most sensitive population subgroups slightly exceed
the chronic DWLOC of 20. However, the chronic EECs were estimated using
Tier I modeling and only slightly exceed the DWLOC. Additional data are
being required that will provide important information on the mobility
of fenarimol and its degradates. These studies will help to refine the
chronic surface and ground water drinking water risk assessments.
The EECs are based on a Tier 1 model FIRST for a turf use scenario
with maximum application rates. The estimated EEC for surface water is
a very conservative estimate. It represents the 1-in-10 year mean
yearly surface water concentration. The Agency's surface water modeling
for drinking water uses a default percent cropped area factor (PCA) for
turf, which represents the fraction of the watershed that is cropped
and treated with the pesticide being modeled. In the absence of a crop-
specific PCA factor, a default PCA of 0.87 is used. The 0.87 factor
represents the maximum fraction of a watershed in the US that is
agriculturally cropped. This default PCA was used for fenarimol
modeling on turf. The Agency is currently attempting to develop PCA
factors specific for turf scenarios, and recognizes that it is unlikely
that 87% of a watershed used for drinking water would be grown to turf
and treated with fenarimol at the maximum rate allowed only for turf
applications especially since applications to turf are limited to golf
courses, and stadium fields or professional athletic fields only.
The default PCA factor assumed and used in fenarimol modeling is
most likely overestimated and adds to the conservatism of the
assessment. Given the relatively low usage of fenarimol across the
country it is highly unlikely that the amount applied to the watershed
in the model will be concentrated in any real watershed used to derive
drinking water. Therefore, the EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit.
The results indicated in the table below are based upon the RED, and
are considered over estimates. Therefore, the risk estimates shown
below are actually lower than what the table reports.
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fenarimol
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population/Subgroup cPAD/mg/kg/ %/cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.002 < 1% 26 16 70
----------------------------------------------------------------------------------------------------------------
All Infants < 1 year old 0.002 < 1% 26 16 20
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.002 < 1% 26 16 20
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Fenarimol is currently
registered for use that could result in short-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic food and water and short-term exposures for fenarimol. Using
the exposure assumptions described in this unit for short-term
exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOE of 1,400 for adult golfers. This
aggregate MOE does not exceed the Agency's level of concern for
aggregate exposure to food and residential uses.
4. Aggregate cancer risk for U.S. population. Fenarimol has been
classified as a ``not likely'' human carcinogen (Group E).
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, and to infants and children from aggregate
exposure to fenarimol residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate methods are available for data collection and enforcement
of tolerances for residues of fenarimol per se in/on plants and
livestock. Adequate methods are also available for determination of
residues of fenarimol and Metabolites B and C in plants Pesticide
Analytical Manual (PAM) Volume II, Methods I (AM-AA-CA-R039-AB-755), II
(AM-AA-CA-R072-AA-755), and III (AM-AA-CA-R124-AA-755.
B. International Residue Limits
There is no CODEX maximum residue limit for filbert.
V. Conclusion
Therefore, the tolerance is established for residues of fenarimol,
[alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol],
in or on filbert at 0.02 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance 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
[[Page 32846]]
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeepingrequirements.
Dated: May 22, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.421 is amended by alphabetically adding a commodity to
the table in paragraph (a)(1) to read as follows:
Sec. 180.421 Fenarimol; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Filbert.................................................... 0.02
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-8659 Filed 6-6-06; 8:45 am]
BILLING CODE 6560-50-S