[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Rules and Regulations]
[Pages 18561-18569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8806]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301109; FRL-6773-2]
RIN 2070-AB78


Fenpyroximate; Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for the 
combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]amino] oxy]methyl]-, 1,1-
dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]aminio]oxy]methyl]-,1,1-
dimethylethyl ester)] in or on wine grapes and hops. Nihon Nohyaku 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act (FQPA) of 1996. The 
tolerance will expire April 12, 2004.

DATES: This regulation is effective April 10, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301109, 
must be received by EPA on or before June 11, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301109 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Melody Banks, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5413; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person

[[Page 18562]]

listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'', ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301109. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of February 18, 1999 (64 FR 8090) (FRL-
6059-9), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of a pesticide petition (PP) for tolerance by 
Nihon Nohyaku, Nihon Noyaku Co., 2-5 Nihonsbashi 1-Chome, Chuoku, Tokyo 
103, Japan. This notice included a summary of the petition prepared by 
Nihon Nohyaku, the registrant.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the insecticide, fenpyroximate 
and its z-isomer, in or on wine grapes at 1.0 parts per million (ppm) 
and hops at 10 ppm. The tolerance will expire April 12, 2004.
    Section 408(b)(2)(A)(i) of the 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) 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) 
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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2), for a tolerance for residues of fenpyroximate and its z-
isomer on wine grapes at 1 ppm and hops at 10 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. The nature of the toxic effects caused by fenpyroximate are 
discussed below following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.
    Fenpyroximate is toxicity category II for oral toxicity (the only 
acute study conducted). Acute studies are not required for import 
tolerances.
    Subchronic and chronic studies in the rat resulted in decreased 
body weight and weight gain (also observed in the mouse carcinogenicity 
study). There were hematological effects and decreased plasma butyryl 
cholinesterase and plasma acetylcholinesterase at higher doses. In the 
subchronic and chronic dog studies there was a bradycardia which did 
not appear to increase in severity with time. Also at this dose 
diarrhea, decreased body weight, body weight gains and food consumption 
were reported. At higher doses, there was also emesis. The high dose in 
the subchronic study resulted in first and second degree heart block, 
increased urea concentration, decreased glucose, and altered plasma 
electrolyte levels among other signs of toxicity.
    Male and female rats were given dietary levels of compound in feed 
for a period of either 13 weeks or 104 weeks. Thirteen week doses 
ranged from 20 ppm to 500 ppm (1.47 mg/kg/day to 36.91 mg/kg/day), 
while 104 week doses ranged from 10 ppm to 150 ppm (0.4 mg/kg/day to 
7.57 mg/kg/day). In the subchronic study, both sexes in the 100 and 500 
ppm groups had impaired growth performance, reduced food intake, and 
decreased body weights and body weight gains. Body weight gains for the 
100 ppm groups were 85% of the control weight gains, and for the 500 
ppm groups were 33-37% of the control gains. At 500 ppm in both sexes, 
hematocrit, hemoglobin, and red blood cell counts were higher, and 
white blood cell counts were lower than the control values. Total 
plasma proteins were also lower. The 500 ppm females had alkaline 
phosphatase activities that were 123% higher and plasma butyryl 
cholinesterase and plasma acetylcholinesterase activities that were 72-
73% lower compared to the controls. Treatment-related effects noted in 
the gross pathology of the 500 ppm groups were facial staining in both 
sexes; encrustations of the muzzle and persistent hyaloid arteries in 
males; and dorsal/ventral hair loss, skin encrustations, skin masses, 
perineal staining, and skin exfoliation in females. The LOAEL was 6.57 
mg/kg/day (100 ppm) for rats, based on decreased body weight gains in 
both sexes. The NOAEL

[[Page 18563]]

was 1.3 mg/kg/day (20 ppm). In the chronic study, similar toxicity was 
observed in males and females in the 75 or 150 ppm groups. Toxicity 
included depressed growth rates that were 86% and 78% of controls in 
males and females, respectively, at 150 ppm in the carcinogenicity 
phase after 104 weeks. Low growth rates were accompanied by less than a 
10% decrease in mean food consumption and a 12-14% reduction in food 
efficiency at the 150 ppm level when compared with controls. The LOAEL 
for systemic toxicity was 75 ppm (3.08 and 3.79 mg/kg/day in males and 
females, respectively), and the NOAEL was 25 ppm (0.97 mg/kg/day for 
males and 1.16 mg/kg/day for females) based on decreased body weight 
gain. Under the conditions of this study, there was no evidence of 
carcinogenic potential. Dosing was considered adequate based on dose-
related decreases in body weight gain and feed consumption in both 
sexes relative to the controls.
    In the mouse carcinogenicity study, doses ranged from 25 to 800 ppm 
(approximately 2.4 - 73.0 mg/kg/day) for up to 18 months. Toxicity was 
similar to that observed in the rat studies and included dose-related 
decreases at 100 ppm and above in mean body weight, weight gain (9, 37, 
and 52% (male); 18, 44, and 60% (female) for increasing doses) and in 
mean feed consumption. Based on decreased body weights and food 
consumption observed at 100 ppm and higher dose levels, the chronic 
LOAEL was established at 100 ppm (9.5 mg/kg/day for male mice and 10 
mg/kg/day for females). The NOAEL was 25 ppm (2.4 mg/kg/day for male 
mice and 2.5 mg/kg/day for females). Under the conditions of this 
study, there was no evidence of carcinogenic potential. Dosing was 
considered adequate based on dose-related decreases in body weight gain 
and feed consumption in both sexes relative to the controls.
    Dogs were given fenpyroximate in capsules for either 13 weeks with 
doses ranging from 2 to 50 mg/kg/day or for 52 weeks with doses ranging 
from 0.5 to 15 mg/kg/day. In the subchronic study, two high dose 
females were sacrificed in extremis during weeks 4 or 5 after a period 
of treatment-related inappetence and body weight loss. Both sexes at 
all treatment levels exhibited slight bradycardia (slow heart rate) and 
a dose-related increase in diarrhea. Emaciation and torpor were 
observed in the 2 mg/kg/day females and in both sexes from the 50 mg/
kg/day groups. Emesis was observed in both sexes at 10 mg/kg/day and 
above. The 50 mg/kg/day male and in all treated female groups had 
reduced body weights and body weight gains (7% (male); 6, 14 and 24% 
(female)). Food consumption was also decreased in all female groups. In 
males, glucose levels and total white blood cell counts were lower at 
10 mg/kg/day and above. Prothombin time values were prolonged and urea 
concentrations were higher in the 50 mg/kg/day females. Absolute and 
relative adrenal gland weights and relative liver weights were 
increased in the 50 mg/kg/day males and females. In the 50 mg/kg/day 
females, there was depleted hepatocytic glycogen and fine vacuolation 
of the cell cytoplasm in the renal medullary rays. One or both of the 
50 mg/kg/day females sacrificed in extremis exhibited first and second 
degree heart block, increased urea concentration, low glucose 
concentration, disturbances in plasma electrolyte levels, depleted 
hepatocytic glycogen, and fine vacuolation of the cell cytoplasm in the 
renal medullary rays. The LOAEL was 2 mg/kg/day based on slight 
bradycardia and an increased incidence of diarrhea in both sexes. In 
females only, there were reduced food consumption, body weight, body 
weight gain, emaciation, and torpor. No NOAEL was established.
    In the chronic dog study, similar signs of toxicity were observed. 
Male beagles in the 5.0 or 15.0 mg/kg/day treatment groups had diarrhea 
more frequently (especially during the first 3-4 months of the study). 
Males in the 15.0 mg/kg/day treatment group were an average 12% 
lighter, consumed 10% less food than the controls, and had heartbeat 
rates 30% slower 24 hours after dosing compared to the 
controls at study termination. Female beagles in the 5.0 or 15.0 mg/kg/
day treatment groups had diarrhea more frequently than control animals. 
The LOAEL was 15.0 mg/kg/day for both male and female beagles, based on 
diarrhea, bradycardia, decreased cholesterol, body weight gain and food 
consumption in males and vomiting, diarrhea, excessive salivation and 
decreased cholesterol in females. The NOAEL was 5.0 mg/kg/day.
    In a 2-generation reproduction study, fenpyroximate was 
administered continuously in the diet at approximate doses ranging from 
0.83 to 8.60 mg/kg/day for females and from 0.67 to 9.92 mg/kg/day for 
males (with some variation depending on generation) (dietary 
concentrations ranging 10 to 100 ppm) for 2 successive generations (1-
litter/generation). No treatment-related effects were observed in the 
10 or 30 ppm treatment groups. The systemic NOAEL was 1.99 and 2.44 mg/
kg/day (30 ppm) for males and females, respectively. The systemic LOAEL 
was 6.59 and 8.60 mg/kg/day (100 ppm) for males and females, 
respectively, based on decreased body weights of both sexes during the 
premating period. The mean premating body weights were slightly 
depressed at 30 ppm, in the P1 males and females (5-6%) and 
significantly depressed in F1 males (14% compared to 
controls; p <0.01); body weight gains for the F1 males were 
also significantly lower (p <0.01). Food consumption at 30 ppm for 
P1 and F1 males was also slightly depressed. The 
mean weights of the 100 ppm P1 females were significantly 
reduced during gestation, and weight gain was 12% lower than in 
controls at gestation day 20 (p <0.05); by the end of lactation the 
weights were similar to control. The mean body weights of the 
F1 females were also lower than controls during gestation 
(6-9%), but recovered to control levels by the end of lactation. For 
reproductive effects, the NOAEL was 2.44 mg/kg/day (30 ppm). The 
reproductive LOAEL was 8.60 mg/kg/day (100 ppm) based on decreased 
lactational weight gain in both generations of pups. Mean pup weights 
were similar in all groups at day 0 of lactation, but the weight gains 
in both generations were decreased at 100 ppm; mean weights at day 25 
were 24% and 15% lower than control (p <0.01) in F1 and 
F2 pups, respectively.
    In a developmental toxicity study, rats were dosed by gavage at 
dose levels of 0, 1.0, 5.0, or 25 mg/kg/day from days 6 through 15 of 
gestation. The maternal NOAEL was 5 mg/kg/day and the LOAEL was 25 mg/
kg/day based on marginal maternal toxicity (decreased body weight gain 
and decreased food consumption). This included a marginal depression in 
maternal body weight and food at 25 mg/kg/day. It is apparent that 
animals could have tolerated higher dose levels of the test material. 
However, since developmental toxicity was observed as noted below, the 
lack of overt maternal toxicity does not affect acceptability of the 
study. The high dose as a LOAEL was also supported by the range-finding 
study. The developmental NOAEL was 5.0 mg/kg/day. The developmental 
LOAEL was 25 mg/kg/day based on increase in the fetal incidence of 
additional thoracic ribs. Additional historical control data (and an 
additional evaluation of the study data on this effect - combined 
bilateral and unilateral incidence by fetus/litter) is requested for 
increased number of thoracic ribs in order to determine whether this is 
in fact a treatment-related effect.
    In a developmental toxicity study, rabbits were dosed by gavage at 
dose levels of 0, 1.0, 2.5, or 5.0 mg/kg/day from days 6 through 19 of 
gestation. Both the maternal LOAEL and the NOAEL were greater than 5.0 
mg/kg/

[[Page 18564]]

day, the highest dose level tested. The developmental LOAEL and the 
NOAEL were also greater than 5.0 mg/kg/day. The Hazard Identification 
Assessment Review Committee (HIARC) considered the occurrence of folded 
retina in the high dose fetuses to be questionable. There was, however, 
a borderline maternal body weight effect at the 5.0 mg/kg/day dose in 
the range-finding study.
    Fenpyroximate is not considered to be a mutagen with the currently 
available data base. The overall quality of the toxicology data base is 
good with the exception of the two developmental toxicity studies. EPA 
is requiring that the developmental toxicity studies in rats and 
rabbits with fenpyroximate be repeated at doses which are adequate to 
characterize developmental susceptibility. Confidence in the hazard and 
dose response is also good with the exception noted above. Although 
there are no data gaps, the two developmental toxicity studies must be 
repeated, and the additional historical control data must be submitted 
as requested for the existing rat developmental study.

B. Toxicological Endpoints

    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. An UF of 100 is routinely used, 10x to account for 
interspecies differences and 10x for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10x 
to account for interspecies differences and 10x for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC, as shown in the following Table 1:

    Table 1.-- Summary of Toxicological Dose and Endpoints for Fenpyroximate for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
          Exposure Scenario                Dose (mg/kg/day)             Endpoint                  Study
----------------------------------------------------------------------------------------------------------------
Acute dietary females - 13 to 50       NOAEL = 5 UF = 100 FQPA  LOAEL = 25 mg/kg/day is  Developmental rat
                                        SF = 10                  based on increase in
                                                                 the fetal incidence of
                                                                 additional thoracic
                                                                 ribs.
 
                                                                Acute RfD = 0.05 mg/kg/
                                                                 day
 
                                                                Acute PAD = 0.005 mg/kg/
                                                                 day
----------------------------------------------------------------------------------------------------------------
Chronic (non-cancer) dietary           NOAEL= 0.97 mg/kg/day    LOAEL = 75 ppm (3.08     Two year rat feeding
                                        UF = 100 FQPA SF = 1     and 3.79 mg/kg/day in    study
                                                                 males and females),
                                                                 based on decreased
                                                                 body weights,
                                                                 accompanied by reduced
                                                                 food efficiency and a
                                                                 slight decrease in
                                                                 mean food consumption.
 
                                                                Chronic RfD = 0.01 mg/
                                                                 kg/day
 
                                                                Chronic PAD = 0.01 mg/
                                                                 kg/day
----------------------------------------------------------------------------------------------------------------
Chronic (cancer) Dietary                   ``Not likely'' to be carcinogenic to humans via relevant routes of
                                                                        exposure
----------------------------------------------------------------------------------------------------------------
Short-, Intermediate, and Long-Term    NOAEL = NA               NA                       NA
 (Dermal)
----------------------------------------------------------------------------------------------------------------
Short-, intermediate, and long-term    NOAEL = NA               NA                       NA
 (Inhalation)
----------------------------------------------------------------------------------------------------------------
NA = Not applicable. This request is for an import tolerance; therefore, applicator exposure risk assessments
  are not required.

    EPA has conducted a risk assessment for the acaricide fenpyroximate 
benzoic acid, 4-[[[[(E)-(1,3-dimethyl1-5-phenoxy-1H-pyrazol-4-yl) 
methylene]amino]oxy]methyl]-, 1,1-dimethylethylethyl ester] and its z-
isomer in support of the establishment of time-limited tolerances on 
imported wine grapes and hops. EPA has evaluated toxicology and residue 
data for fenpyroximate submitted by Nihon Nohyaku.
    Fenpyroximate is registered for use on grapes in Germany, France, 
Portugal, and Italy and on hops in Germany. The

[[Page 18565]]

maximum application rate for fenpyroximate is 130 grams active 
ingredient hectare (g/a.i./ha) (0.12 lb. a.i./acre) for grapes and 263 
g a.i./ha (0.23 lb. a.i./acre) for hops. The preharvest interval (PHI) 
is 21 days for hops and 14 days for grapes.
    The proposed use is limited to imported wine grapes and hops only. 
Therefore, no water or occupational or residential exposure assessments 
are required.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances are being 
established (40 CFR 180.566) for the residues of fenpyroximate, in or 
on Wine grapes and hops. Risk assessments were conducted by EPA to 
assess dietary exposures from fenpyroximate in food as follows.
    i. Dietary exposure and risk analysis. A dietary exposure analysis 
using the Dietary Exposure Evaluation Model (DEEM) was completed (Memo, 
J. Rowell, D271394, January 11, 2001) for acute and chronic (non-
cancer). The DEEM analysis evaluated the individual food consumption as 
reported by respondents in the USDA 1989-91 Continuing Surveys for Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made: tolerance 
level residues were used and 100% Crop Treated (CT) was assumed for all 
commodities. Default DEEM concentration factors were used for all 
processed food forms.
    The acute dietary exposure analysis estimates the distribution of 
single-day exposures for the U.S. population and certain subgroups. 
Each analysis assumes uniform distribution of fenpyroximate for the 
commodities on which fenpyroximate is used.
    The Tier 1 acute analysis was performed for females 13-50 years old 
using tolerance levels and assuming 100% CT information for all 
commodities. EPA retained the 10x safety factor for the females 13-50 
years old in acute dietary risk assessments only, therefore the acute 
RfDs for these subgroups have been adjusted to reflect the aPAD. The 
aPAD for females 13-50 years old is 0.005 (0.05 mg/kg/day  10 = 
0.005 mg/kg/day). For acute dietary risk, EPA's level of concern is 
>100% aPAD. Dietary exposures and associated acute risk for females 13-
50 are shown in the following Table 2:

          Table 2.--Summary of Results of Acute DEEM Analysis for Fenpyroximate at the 95th Percentile
----------------------------------------------------------------------------------------------------------------
                     Subgroups                              Exposure (mg/kg/day)                  % aPAD
----------------------------------------------------------------------------------------------------------------
Females (13+ years old/pregnant/not nursing)                                   0.000000                        0
----------------------------------------------------------------------------------------------------------------
Females (13+ years old/nursing)                                                0.000098                        2
----------------------------------------------------------------------------------------------------------------
Females (13-19 years old/not pregnant/not nursing)                             0.000000                        0
----------------------------------------------------------------------------------------------------------------
Females (20+ years old/not pregnant/not nursing)                               0.000208                        4
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                                      0.000160                        3
----------------------------------------------------------------------------------------------------------------

    The results of the acute analysis indicate that at the 95th 
percentile the acute dietary risk associated with the proposed uses of 
fenpyroximate is below EPA's level of concern.
    ii. Chronic Exposure. In conducting this chronic dietary risk 
assessment the DEEM analysis evaluated the individual food consumption 
as reported by respondents in the USDA 1989-1991 nationwide CSFII and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the chronic exposure assessments: Tolerance 
level residues were used and 100% CT was assumed for all commodities. 
Default DEEM concentration factors were used for all processed food 
forms.
    The chronic dietary exposure analysis used mean consumption (3-day 
average) data. The Tier 1 chronic analysis was performed using 
tolerance levels and assuming 100% CT information for all commodities. 
For chronic risk assessments, the 10x safety factor was removed 
(reduced to 1x), therefore the chronic RfD and cPAD are equivalent. The 
cPAD for the U.S. population and all subgroups is 0.01. For chronic 
dietary risk, EPA's level of concern is >100% cPAD. Dietary exposures 
for the U.S. population and other subgroups are presented in Table 3. 
The other subgroups included in Table 3 represent the highest dietary 
exposures for their respective subgroups (i.e., children, infants, and 
male subgroups).

                    Table 3.--Summary of Results from Chronic DEEM Analysis of Fenpyroximate
----------------------------------------------------------------------------------------------------------------
                Subgroups                              Exposure (mg/kg/day)                       % cPAD
----------------------------------------------------------------------------------------------------------------
U.S. population (48 states)                                                    0.000099                        1
----------------------------------------------------------------------------------------------------------------
All infants (>1 yr old)                                                     no exposure                        -
----------------------------------------------------------------------------------------------------------------
Children 1-6 yrs. old                                                          0.000002                        0
----------------------------------------------------------------------------------------------------------------
Females 13+ years old (nursing)                                                0.000166                        2
----------------------------------------------------------------------------------------------------------------
Males 20+ yrs old                                                              0.000138                        1
----------------------------------------------------------------------------------------------------------------

    The results of the chronic analysis indicate that the chronic 
dietary risk associated with the proposed uses of fenpyroximate is 
below EPA's level of concern for the U.S. population and all subgroups.
    iii. Cancer dietary risk. Fenpyroximate was classified as ``not 
likely'' to be carcinogenic to humans via relevant routes of exposure 
using the proposed new guidelines (RfD document dated February 19, 
1997).

[[Page 18566]]

 Therefore, no cancer dietary exposure analysis was performed.
    2. Dietary exposure from drinking water. The use on wine grapes and 
hops is an import use only. At present there is one registered use for 
fenpyroximate in the U.S. for ornamental greenhouse use. No run-off to 
surface water or drainage to ground water is expected.
     Therefore, a drinking water exposure assessment is not necessary. 
If domestic uses are added in the future, OPP will reassess the 
potential impacts of fenpyroximate on drinking water as a part of the 
aggregate risk assessment process.
    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).
    Fenpyroximate is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) 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 does not have, at this time, available data to determine 
whether fenpyroximate has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
fenpyroximate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that fenpyroximate 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 final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. FFDCA 
section 408 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 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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Prenatal and postnatal sensitivity. Although there are no 
toxicity data gaps according to EPA's Subdivision F Guideline 
requirements for an import tolerance, EPA is requiring that the 
developmental toxicity studies in rats and rabbits be repeated at doses 
which are adequate to characterize developmental susceptibility. EPA is 
retaining the 10x FQPA safety factor due to uncertainties in evaluating 
potential susceptablilty following in utero exposure as a result of 
inadequate developmental toxicity studies in both species (rat and 
rabbit). This should be applied only to females 13 to 50 for the 
determination of acute dietary risk because the potential effects occur 
only during in utero exposure and are not postnatal effects.
    The FQPA safety factor is reduced to 1x for chronic dietary risk 
assessment because the developmental toxicity studies (for which we 
have uncertainty) are not relevant to chronic risk assessments (in 
utero exposure is not chronic) for the following reasons: (1) The NOAEL 
used in deriving the RfD was based on decreased body weight gain in 
rats in the rat chronic toxicity/carcinogenicity study; (2) the 
developmental effects on which the FQPA factor is based were seen in 
pregnant animals; and (3) the developmental effects are considered to 
be ``acute'' effects. There was no evidence of increased susceptibility 
in the multigeneration reproduction study, a longer study.
    EPA concluded that the doses selected in the developmental toxicity 
studies with rats and rabbits should have been higher since the highest 
doses produced only marginal maternal toxicity, or were supported by 
marginal toxicity in range finding studies. Additionally, there is some 
question as to the significance (due to maternal toxicity or to direct 
fetal effects) of fetal variations in both species (rats- increased 
thoracic ribs, rabbits-questionable increase in retinal folding). 
Therefore, EPA could not dismiss the possibility of increased 
susceptibility in both species.
    EPA further concluded that the data from the 2-generation 
reproduction study in rats provided no indication of quantitative or 
qualitative increased susceptibility since maternal toxicity and 
reproductive toxicity occurred at the same dose.
    A developmental neurotoxicity study was not recommended because 
neurotoxic compounds of similar structure were not identified and there 
was no evidence of neurotoxicity in the current toxicity data base.
    iii. Conclusion. The toxicological data base for fenpyroximate is 
adequate to support a time-limited import tolerance. Fenpyroximate 
exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures. EPA is retaining the 10x 
FQPA safety factor due to uncertainties in evaluating potential 
susceptablilty following in utero exposure as a result of inadequate 
developmental toxicity studies in both species (rat and rabbit). This 
should be applied only to females 13 to 50 for the determination of 
acute dietary risk because the potential effects occur only during in 
utero exposure and are not postnatal effects.
    2. Acute risk. The Aggregate acute risk is the same as the acute 
risk set forth in Unit III.C.1.i. The other registered use does not 
contribute to aggregate acute risk.
    3. Chronic risk. The chronic acute risk is the same as the chronic 
risk set forth in Unit III.C.1.i. The other registered use does not 
contribute to chronic acute risk.
    4. 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example: gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits 
for residues of fenpyroximate in wine grapes and hops. Therefore, a 
compatibility issue is not relevant to the proposed tolerances.

[[Page 18567]]

C. Conditions

    The petitioner is required to perform storage stability studies in 
grape juice and grapes. As Chile is a major source of wine, additional 
grape residue data from this country and a translation of the Chilean 
label are required. Additional information on uses of fenpyroximate in 
Mexico and a translation of the Mexician label are required. The 
specificity of Method DFG S 19 should be demonstrated by performing an 
interference study with all pesticides for which tolerances are 
established on grapes and hops. Alternatively, a very specific 
confirmatory method (e.g., uses of MS detection) should be submitted. 
The two developmental toxicity studies must be repeated and historical 
control data submitted for the existing rat developmental study.

V. Conclusion

    Therefore, a tolerance with an expiration of 3 years after date of 
publication in the Federal Register is established for residues of 
fenpyroximate, benzoic acid, 4-[[[(E)-)1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl) methylene]amino]oxy]methyl-, 1,1-dimethylethyl ester], 
and its z-isomer in or on wine grapes at 1.0 ppm and hops at 10 ppm.

VI. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301109 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 June 11, 
2001.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301109, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance 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). 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

[[Page 18568]]

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 FFDCA section 408(d), such as the exemption 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 FFDCA section 408(n)(4). 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.

VIII. Submission to Congress and the Comptroller General

    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 
recordkeeping requirements.


    Dated: March 27, 2001.

Joseph J. Merenda,

Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), (346a) and 371.


    2. Section 180.566 is added to read as follows:


Sec. 180.566  Fenpyroximate; tolerances for residues.

    (a) General. This regulation establishes a time-limited tolerance 
for the combined residues of fenpyroximate benzoic acid, 4-[[[(E)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene] amino] oxy]methyl]-, 
1,1-dimethylethyl ester] and its z-isomer benzoic acid, 4-[[[[(Z)-(1,3-
dimethyl-5-phenoxy-1H-pyrazol-4-yl) methylene]aminio] oxy]methyl]-, 
1,1-dimethylethyl ester)] in or on wine grapes and hops. These 
tolerances will expire and are revoked on the dates specified in the 
following table.

 
----------------------------------------------------------------------------------------------------------------
                                            Parts per
                Commodity                    million                   Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
Hops\1\..................................           10                                           April 12, 2004.
Wine grapes\1\...........................          1.0                                           April 12, 2004.
----------------------------------------------------------------------------------------------------------------
\1\There are no U.S. registrations on Hops and Wine grapes.


[[Page 18569]]

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 01-8806 Filed 4-9-01; 8:45 am]
BILLING CODE 6560-50-S