[Federal Register Volume 75, Number 180 (Friday, September 17, 2010)]
[Rules and Regulations]
[Pages 56892-56897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-23120]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009--0623; FRL-8844-6]


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 including its metabolites and degradates in or on vegetable, 
cucurbit, group 9. Gowan Company requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 17, 2010. Objections and 
requests for hearings must be received on or before November 16, 2010, 
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-2009-0623. All documents in the 
docket are listed in the docket index available at http://
www.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: Mary L. Waller, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9354; e-mail address: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="a0d7c1ccccc5d28ecdc1d2d9e0c5d0c18ec7cfd6">[email protected]</a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To 
access the harmonized test guidelines referenced in this document 
electronically, please go http://www.epa.gov/ocspp and select ``Test 
Methods and Guidelines.''

C. How Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0623 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 16, 2010. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0623, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 Facility'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. Summary of Petitioned-For Tolerance

    In the Federal Register issue of September 4, 2009 (74 FR 45848) 
(FRL-8434-4), EPA issued a notice pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7566) by Gowan Company, 370 South Main St., Yuma, AZ 85364. The 
petition requested that 40 CFR part 180 be amended by establishing a 
tolerance for residues of the fungicide fenarimol and its metabolites 
in or on cucurbits at 0.2 parts per million (ppm). That notice 
referenced a summary of the petition prepared by Gowan Company, the 
registrant, which is available in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    EPA has revised the commodity expression for cucurbits and has 
revised the tolerance expression for all

[[Page 56893]]

established commodities to be consistent with current Agency policy. 
The reason for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fenarimol including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with fenarimol 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.
    Fenarimol has a relatively low order of acute toxicity via the 
oral, dermal, and inhalation routes of exposure. It is not a dermal 
sensitizer. It is a moderate eye irritant and causes corneal opacity in 
rabbits. Chronic studies indicate that the liver is a target organ for 
toxicity. Liver toxicity was manifested by liver weight increases and 
the presence of ``fatty liver'' in rats. In dogs, increased liver 
weights and increases in serum enzymes, indicative of liver toxicity, 
were noted. However, the effects of fenarimol on aromatase, an enzyme 
involved in the conversion of androgens to estrogens, is the basis for 
toxicity endpoints. The inhibition of aromatase by fenarimol results in 
adverse effects in both males and females as indicated in the 
reproduction and developmental studies. There were no indications of a 
direct effect of fenarimol on the immune system. Fenarimol has been 
classified as not likely to be a human carcinogen, and demonstrates no 
mutagenic effects.
    Developmental and/or reproductive toxicity studies showed no 
evidence of increased sensitivity or susceptibility of young rats or 
rabbits. However, fenarimol affects the male's reproductive performance 
and in females results in dystocia. Fenarimol was evaluated in two 
special studies in females rats, a pubertal assay which screened for 
estrogenic and thyroid activity during sexual maturation and for 
abnormalities associated with sex organs, puberty markers, and thyroid 
tissue and an uterotrophic assay which screened for estrogenic effects 
including uterine weight changes measured in ovariectomised and 
immature animals. In the pubertal assay at 50 and 250 milligram/
kilogram/day (mg/kg/day) for 21 days, no adverse effects were found 
except for a decrease in the thyroid hormone T4 and an increase in 
circulating thyroid-stimulating hormone (TSH) levels. In the 
uterotrophic assay, a dose of 200 mg/kg/day resulted in a significant 
increase of uterine weights which were accompanied by an increase in 
serum follicle-stimulating hormone (FSH) levels and a decrease in serum 
T3 levels but at much higher doses than the regulatory endpoints 
selected.
    Specific information on the studies received and the nature of the 
adverse 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.regulations.gov in document ``Fenarimol. Human Health Risk 
Assessment for the Proposed New Food Use of Fenarimol in/on Imported 
Cucurbit Vegetables, Crop Group 9'' at pp. 46-49 in docket ID number 
EPA-HQ-OPP-2009-0623.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level - generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD) - and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenarimol used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1.--Summary of Toxicological Doses and Endpoints for Fenarimol for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                       Point of Departure and
          Exposure/Scenario              Uncertainty/Safety     RfD, PAD, LOC for Risk   Study and Toxicological
                                              Factors                 Assessment                 Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                         Not applicable           Not applicable           No appropriate hazard
 (All populations)..................                                                     was identified for
                                                                                         single-dose risk
                                                                                         assessment.
----------------------------------------------------------------------------------------------------------------

[[Page 56894]]

 
Chronic dietary                       NOAEL= 0.6 mg/kg/day     Chronic RfD = 0.006 mg/  Rat reproduction LOAEL =
(All populations)...................  UFA = 10x..............   kg/day                   1.2 mg/kg/day based on
                                      UFH = 10x..............  cPAD = 0.006 mg/kg/day.   decreased live born
                                      FQPA SF = 1x...........                            litter size
----------------------------------------------------------------------------------------------------------------
Dermal short-term                     LOAEL = 35 mg/kg/day     LOC for MOE = 1,000      Special Reproduction
(1 to 30 days)......................   (dermal absorption                                Study (Rat) LOAEL = 35
                                       rate = 5%                                         mg/kg/day based on
                                      UFA = 10x..............                            decreased fertility and
                                      UFH = 10x..............                            dystocia, an indication
                                      FQPA SF = 10x (as an                               of hormonal effects
                                       UFL).
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenarimol, EPA considered exposure under the petitioned-for 
tolerances as well as all existing fenarimol tolerances in 40 CFR 
180.421. EPA assessed 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. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Surveys 
of Food Intakes by Individuals (CSFII). The chronic dietary exposure 
assessment for fenarimol is highly refined using anticipated residues 
based on USDA Pesticide Data Program (PDP) monitoring data for apples, 
bananas, cherries, grapes, and pears. Field trial residue data were 
used for cantaloupe, cucumber, filberts, hops, pecans, and summer 
squash. Tolerance level residues were assumed for all other 
commodities. Percent crop treated (PCT) information was used for 
apples, cherries, grapes, and pears, and 100 PCT was assumed for all 
other crops.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenarimol does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> 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.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    <bullet> Apples - 15%.
    <bullet> Cherries - 5%.
    <bullet> Grapes - 20%.
    <bullet> Pears - 5%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6-7 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for fenarimol and its degradates (U-1, U-2, U-6, and U-7) in 
drinking water. These simulation models take into account data on the 
physical, chemical, and fate/transport characteristics of fenarimol. 
Further information regarding EPA drinking water models used in 
pesticide exposure assessment can be found at http://www.epa.gov/
oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) for

[[Page 56895]]

chronic exposures for non-cancer assessments are estimated to be 66 
parts per billion (ppb) for surface water and 19 ppb for ground water. 
Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 66 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Fenarimol is currently registered for use on professionally managed 
turf areas, such as stadia and golf course tees, greens, and fairways. 
Short-term post-application dermal exposure to golfers is possible. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
    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.''
    EPA has not found fenarimol to share a common mechanism of toxicity 
with any other substances, and fenarimol does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fenarimol does not 
have 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 EPA's website at http://www.epa.gov/pesticides/
cumulative.

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 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. The database for prenatal 
developmental (in rats and rabbits) and reproductive (in rats) toxicity 
is complete and includes special studies in addition to conventional 
guideline studies. The rat developmental study showed evidence of 
hydronephrosis in fetuses at dose levels equal to or possibly lower 
than doses causing maternal toxicity; however, a special study showed 
this effect to be reversible and therefore not considered an adverse 
effect.
    Additionally, the decreased live born litter size and survival 
indices in the rat multi-generation reproduction study are considered 
to be a secondary consequence of parental effects (e.g., dystocia and 
fertility), and is not an indicator of increased susceptibility. 
Therefore, there is no evidence of increased susceptibility of fetuses 
following in utero exposure in the rat or rabbit developmental toxicity 
study or of offspring following prenatal and postnatal exposure in the 
rat reproduction study, and there are no concerns or residual 
uncertainties for prenatal and/or postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for assessing chronic risk. That decision is 
based on the following findings:
    i. The toxicity database for fenarimol is complete except for 
immunotoxicity testing. Changes to 40 CFR part 158 make immunotoxicity 
testing (OPPTS Harmonized Test Guideline 870.7800) required for 
pesticide registration; however, the available data for fenarimol do 
not show the potential for immunotoxicity. Consequently, the EPA 
believes the existing data are sufficient for endpoint selection for 
exposure/risk assessment scenarios and for evaluation of the 
requirements under the FQPA, and an additional database UF does not 
need to be applied.
    ii. There is no indication that fenarimol 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 fenarimol results in increased 
susceptibility in in utero 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. The chronic dietary food exposure assessment utilized 
tolerance-level residues, anticipated residue data that are based on 
reliable field trial data, or food monitoring data collected by USDA 
under the PDP. For several currently registered commodities, the 
chronic assessment also utilized PCT data that have a valid basis and 
are considered to be reliable. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to fenarimol in drinking water. EPA used similarly 
conservative assumptions to assess post-application residential 
exposure. These assessments will not underestimate the exposure and 
risks posed by fenarimol.
    EPA has retained a 10X FQPA SF for assessing short-term risk 
because the study used in assessing short-term risk did not identify a 
NOAEL for the effects observed. The Agency is confident that the 10X 
FQPA SF is adequate (as opposed to a larger SF) for assessing risks 
from short-term exposure to fenarimol based on the following weight of 
evidence considerations.
    <bullet> The most sensitive endpoint for target organ toxicity 
(potential interaction with the androgen and/or estrogen pathway) is 
being used for these (short-term) exposure scenarios and this selection 
is supported by and comparable to the endpoint (reproductive effects) 
used in assessing dietary and non-dietary risks for intermediate and 
chronic exposures.
    <bullet> Fenarimol has been evaluated in two of the Tier 1 assays 
developed by the Agency's Endocrine Disruption Screening Program, the 
``Female Pubertal Assay'' and the ``Uterotrophic Assay.''
     <bullet> In the female pubertal assay, following oral exposure for 
21 days- (which is comparable to the short-term exposure scenario of 
concern)- no adverse effects on sexual maturation, abnormalities 
associated with sex organ, or pubertal markers were seen at doses up to 
and including 250 mg/kg/day.
     <bullet> In the uterotrophic assay, following oral exposure for 3 
days, a dose of 200 mg/kg/day resulted in increased uterine weight.
    <bullet> As noted in Unit III.A., the uterotrophic response was 
seen at a much higher dose (200 mg/kg/day) than the regulatory doses 
used for overall risk assessments: Extrapolated NOAEL of 3.5 mg/kg/day 
for short-term and a NOAEL of 0.6 mg/kg/day for assessing intermediate 
and long-term dietary and non-dietary risks.

[[Page 56896]]

    <bullet> Specifically, the extrapolated NOAEL of 3.5 mg/kg/day used 
for short-term assessments is approximately 60-fold lower than the 
uterotrophic response found in rats at 200 mg/kg/day.
This weight of evidence provides sufficient confidence that the default 
10X FQPA SF is adequate (i.e, the LOC is a MOE of 1,000) and it would 
not underestimate short-term risk from exposure to fenarimol.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
fenarimol is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenarimol from food and water will utilize 77% of the cPAD for all 
infants < 1 year old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
fenarimol is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Fenarimol is currently registered for use on professionally managed 
turf, including stadia and golf course tees, greens, and fairways which 
could result in short-term post-application dermal exposure to golfers. 
The Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-term residential exposures 
to fenarimol.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,800 for adults 
20-49 years old. While the residential scenario is based on an adult 
population, careful analyses of body weight-to-surface area ratios and 
durations of exposure resulted in the conclusion that mitigation for 
this population subgroup will also be protective for all population 
subgroups including young adults and children. Because EPA's LOC for 
fenarimol is a MOE of 1,000 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fenarimol is not expected to pose a cancer risk to humans.
    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 fenarimol residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) with an 
electrolytic conductivity detector (ECD)) is available to enforce the 
tolerance expression. PAM Volume II lists three GC/ECD methods, 
designated as Methods I (AM-AA-CA-R039-AB-755), II (AM-AA-CA-R072-AA-
755), and III (AM-AA-CA-R124-AA-755) for tolerance enforcement.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by section 
408(b)(4) of FFDCA. The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, section 408(b)(4) of FFDCA requires that EPA 
explain the reasons for departing from the Codex level.
    The Codex has established an MRL for fenarimol in or on melons, 
except watermelon at 0.05 ppm. This MRL is different than the tolerance 
of 0.20 ppm for vegetable, cucurbit, group 9 established for fenarimol 
in the United States. The tolerances cannot be harmonized because the 
field trial data demonstrated higher residues than the Codex MRL.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the petitioned-for tolerance ``cucurbits'' to 
``vegetable, cucurbit, group 9'' to agree with the Agency's Food and 
Feed Commodity Vocabulary. Additionally, the Agency has revised the 
tolerance expression to clarify that, as provided in section 408(a)(3), 
of FFDCA the tolerance covers metabolites and degradates of fenarimol 
not specifically mentioned, and that compliance with the specified 
tolerance levels is to be determined by measuring only the specific 
compounds mentioned in the tolerance expression.

V. Conclusion

    Therefore, a tolerance is established for residues of fenarimol, 
alpha-(2 chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol, in 
or on vegetable, cucurbit, group 9 at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory

[[Page 56897]]

Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate 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: September 9, 2010.
G. Jeffrey Herndon,
Acting 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. In Sec.  180.421, revise the introductory text of paragraph (a) and 
add alphabetically the entry ``vegetable, cucurbit, group 9'' to the 
table in paragraph (a) to read as follows:


Sec.  180.421  Fenarimol; tolerances for residues.

    (a) General. Tolerances are established for residues of fenarimol, 
including its metabolites and degradates, in or on the commodities in 
the following table. Compliance with the tolerance levels specified in 
the following table is to be determined by measuring only fenarimol 
alpha-(2 chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol.

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Vegetable, cucurbit, group 9*..................                 0.20 ppm
------------------------------------------------------------------------
*There are no U.S. registrations as of August 27, 2010.

* * * * *

FR Doc. 2010-23120 Filed 9-16-10; 8:45 am
BILLING CODE 6560-50-S


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