Document ID: EPA-HQ-OPP-2005-0297-0001
Agency: epa
Document Type: Rule
Title: Fenarimol; Pesticide Tolerance
Posted Date: 2006-06-07T12:52:30Z

[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