[Federal Register Volume 69, Number 92 (Wednesday, May 12, 2004)]
[Rules and Regulations]
[Pages 26305-26312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10455]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0094; FRL-7358-2]


Pyraflufen-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of pyraflufen-ethyl, (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid 
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4- fluorophenoxyacetic acid), in or on wheat, forage; 
wheat, grain; wheat, hay; and wheat, straw. Nichino America 
Incorporated requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 
1996 (FQPA).

DATES: This regulation is effective May 12, 2004. Objections and 
requests for hearings must be received on or before July 12, 2004.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
ID number OPP-2004-0094. All documents in the docket are listed in the 
EDOCKET index at http://www.epa.gov/edocket. Although listed in the 
index, some information is not publicly available, i.e., 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 either electronically in 
EDOCKET or in hard copy at the Public Information and Records Integrity 
Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis 
Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers; dairy cattle farmers; livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

[[Page 26306]]

II. Background and Statutory Findings

    In the Federal Register of November 20, 2002 (67 FR 70073) (FRL-
7184-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1F6428) by Nichino America Incorporated, 4550 New Linden Hill Road, 
Suite 501, Wilmington, DE 19808. That notice included a summary of the 
petition prepared by Nichino America Incorporated, the registrant. 
There were no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.585 be amended by 
establishing tolerances for combined residues of the herbicide 
pyraflufen-ethyl, (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methylpyrazol-3-yl)-4-fluorophenoxyacetate) and its acid metabolite, E-
1, (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methypyrazol-3-yl)-4-
fluorophenoxyacetic acid), expressed as the ester equivalent, in or on 
wheat forage, wheat grain, wheat hay, and wheat straw at 0.01 parts per 
million (ppm).
    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....''
    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 of FFDCA 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) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for combined residues of pyraflufen-
ethyl on wheat, forage and wheat, hay at 0.1 ppm; and wheat, grain and 
wheat, straw at 0.01 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 pyraflufen-ethyl as 
well as the no observed adverse effect level (NOAEL) and the lowest 
observed adverse effect level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of April 30, 2003 (68 FR 
23046) (FRL-7300-9).

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.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    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 an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, 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 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.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 x 
10-\5\), one in a million (1 x 10-\6\), or one in 
ten million (1 x 10-\7\). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure

[[Page 26307]]

(MOEcancer = point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for pyraflufen-ethyl used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of April 30, 2003 (68 FR 23046) (FRL-
7300-9).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.585) for the combined residues of pyraflufen-
ethyl (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1- methyl-1H-
pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid metabolite, E-1 (2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H- pyrazol-3-yl)-4-
fluorophenoxyacetic acid), expressed as the ester equivalent, in or on 
a variety of raw agricultural commodities. Risk assessments were 
conducted by EPA to assess dietary exposures from pyraflufen-ethyl in 
food as follows:
    i. Acute exposure. Acute dietary 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 one-day 
or single exposure. No adverse effect attributable to a single exposure 
(dose) was observed in oral toxicity studies, including the 
developmental toxicity studies in rats and rabbits. Therefore, EPA did 
not identify an acute dietary endpoint and an acute dietary assessment 
was not performed.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. The following assumptions were made for 
the chronic exposure assessments: 100 percent crop treated (PCT) and 
tolerance-level residues for pyraflufen-ethyl on all treated crops. The 
exposure for pyraflufen-ethyl residues in food occupies less than 1% of 
the chronic percent adjusted dose (cPAD) for all population subgroups 
and is not a concern.
    iii. Cancer. The cancer dietary exposure assessment was conducted 
using the DEEM analysis, which evaluated the individual food 
consumption as reported by respondents in the USDA nationwide CSFII 
1994-1996 and 1998. The following assumptions were made for the cancer 
assessments: 100 PCT and tolerance-level residues for pyraflufen-ethyl 
on all treated crops. The exposure from pyraflufen-ethyl residues in 
food results in a cancer risk in the range of 1 in 1 million and is not 
a concern.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for pyraflufen-ethyl in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the chemical and 
physical characteristics of pyraflufen-ethyl.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to pyraflufen-ethyl they 
are further discussed in the aggregate risk sections in unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of pyraflufen-
ethyl for acute exposures are estimated to be 1.25 parts per billion 
(ppb) for surface water and 0.002 ppb for ground water. The EECs for 
chronic exposures are estimated to be 0.28 ppb for surface water and 
0.002 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Pyraflufen-ethyl is currently registered for use on the following 
residential non-dietary sites: Airports, nurseries, ornamental turf, 
golf courses, roadsides, railroads, noncrop land, and uncultivated 
agricultural areas. The risk assessment was conducted using the 
following residential exposure assumptions: Adults and children may be 
exposed to residues of pyraflufen-ethyl through postapplication contact 
with treated areas which may include residential/recreational areas.
    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 does not have, at this time, available data to determine 
whether pyraflufen-ethyl has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to pyraflufen-
ethyl and any other substances and pyraflufen-ethyl 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 
pyraflufen-ethyl has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements

[[Page 26308]]

released by EPA's OPP concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rat or rabbit fetuses following in utero 
exposure in the developmental studies with pyraflufen-ethyl. There is 
no evidence of increased susceptibility of young rats in the 
reproduction study with pyraflufen-ethyl. EPA concluded there are no 
residual uncertainties for pre- and/or postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for 
pyraflufen-ethyl and exposure data are complete or are estimated based 
on data that reasonably accounts for potential exposures. The field 
trial data on wheat, while some of which may be limited in geographic 
representation, indicate that residues of pyraflufen-ethyl are expected 
to be below the levels of quantitation. The likelihood of finite 
residues to occur in these crops is quite low. EPA determined that the 
10X SF to protect infants and children should be removed and instead, a 
different additional safety factor of 1X should be used. The FQPA 
factor is removed because: There is no evidence of increased 
susceptibility of rat or rabbit fetuses following in utero exposure in 
the developmental studies with pyraflufen-ethyl; there is no evidence 
of increased susceptibility of young rats in the reproduction study 
with pyraflufen-ethyl; there are no residual uncertainties identified 
in the exposure databases; the dietary food exposure assessment is 
expected to be conservative, tolerance-level residues and 100 PCT 
information were used; and dietary drinking water exposure is based on 
conservative modeling estimates.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs are theoretical 
upper limits on a pesticide's concentration in drinking water in light 
of total aggregate exposure to a pesticide in food and residential 
uses. In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + residential exposure)). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 
1L/10 kg (child). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. No adverse effect attributable to a single exposure 
(dose) of pyraflufen-ethyl was observed in the oral toxicity studies, 
including the developmental toxicity studies in rats and rabbits. 
Therefore, an acute reference dose was not established and no acute 
risk is expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
pyraflufen-ethyl from food will utilize < 1% of the cPAD for the U.S. 
population and < 1% of the cPAD for children (1-6 years). Based on the 
use pattern, chronic residential exposure to residues of pyraflufen-
ethyl is not expected. In addition, there is potential for chronic 
dietary exposure to pyraflufen-ethyl in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in Table 1 of this unit:

            Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Pyraflufen-ethyl
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                                                                             Surface       Ground
                                                 cPAD mg/kg/     % cPAD       Water        Water       Chronic
             Population Subgroup\1\                  day         (Food)       EEC\2\       EEC\2\      DWLOC\3\
                                                                              (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                         0.20          < 1         0.28        0.002        7,000
---------------------------------------------------------------------------
Males (20+ years)                                       0.20          < 1         0.28        0.002        7,000
---------------------------------------------------------------------------
Males (13-19 years)                                     0.20          < 1         0.28        0.002        7,000
---------------------------------------------------------------------------

[[Page 26309]]

 
Females (13-50 years)                                   0.20          < 1         0.28        0.002        6,000
---------------------------------------------------------------------------
Children (1-6 years)                                    0.20          < 1         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
\1\ Subgroups with the highest food-source dietary exposure were selected for adult males, adult females, and
  children. The following body weights were used (70 kg adult male; 60 kg adult females; 10 kg child).
\2\ The crop producing the highest level was used (potatoes, 0.009 lb ai/acre).
\3\ Chronic DWLOC (ppb) = maximum chronic water exposure (mg/kg/day) x body weight (kg) / water consumption (L)
  x 10-\3\ mg/[mu]g.

    3. Short-term risk. The short-term aggregate risk assessment 
estimates risks likely to result from 1 to 30 day exposure to 
pyraflufen-ethyl residues from food, drinking water, and residential 
pesticide uses. High-end estimates of residential exposure are used in 
the short-term aggregate assessment, while average (chronic) values are 
used to account for dietary (food only) exposure. The short-term 
aggregate risk assessment is considered conservative because food-
source dietary exposure is based on a Tier 1 DEEM assessment (tolerance 
level residues and 100 PCT information were used).
    A short-term risk aggregate assessment was not performed for adults 
because no handler exposure is expected and postapplication inhalation 
exposure is expected to be negligible. A short-term aggregate risk 
assessment is required for infants and children because there is a 
potential for oral post-application exposure resulting from contact 
with treated areas which may include residential/recreational areas.
    Short-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Pyraflufen-ethyl is currently registered for use that could result 
in short-term residential exposure and the Agency has determined that 
it is appropriate to aggregate chronic food and water and short-term 
exposures for pyraflufen-ethyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures 
aggregated result in aggregate MOEs of 120,500 for children (3-5 years 
old). These aggregate MOEs do not exceed the Agency's level of concern 
for aggregate exposure to food and residential uses. In addition, 
short-term DWLOCs were calculated and compared to the EECs for chronic 
exposure of pyraflufen-ethyl in ground and surface water. After 
calculating DWLOCs and comparing them to- the EECs for surface and 
ground water, EPA does not expect short-term aggregate exposure to 
exceed the Agency's level of concern, as shown in Table 2 of this unit:

                 Table 2.--Aggregate Risk Assessment for Short-Term Exposure to Pyraflufen-ethyl
----------------------------------------------------------------------------------------------------------------
                                                  Aggregate    Aggregate     Surface       Ground
                                                   MOE \1\      Level of      Water        Water      Short-Term
              Population Subgroup                  (Food +      Concern       EEC\2\       EEC\2\      DWLOC\3\
                                                Residential)     (LOC)        (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Children (3-5 years)                                 120,500          100         0.28        0.002        2,000
----------------------------------------------------------------------------------------------------------------
\1\ Aggregate MOE = NOAEL / (Avg food exposure + Residential exposure).
\2\ The crop producing the highest level was used (potatoes, 0.009 lb ai/acre).
\3\ DWLOC (ppb) = maximum water exposure (mg/kg/day) x body weight (kg) body weight: Children-10 kg / water
  consumption (L) x 10-\3\ mg/[mu]g.

    4. Intermediate-term risk. The intermediate-term aggregate risk 
assessment estimates risks likely to result from 1 to 6 months of 
exposure to pyraflufen-ethyl residues from food, drinking water, and 
residential pesticide uses. High-end estimates of residential exposure 
are used in the intermediate-term assessment, while average values are 
used for food and drinking water exposure.
    An intermediate-term risk aggregate assessment is not required for 
adults because no handler exposure is expected and postapplication 
inhalation exposure is expected to be negligible. Also, an 
intermediate-term aggregate risk assessment is not required for infants 
and children because postapplication exposure over the intermediate-
term duration is not likely based on the use pattern. Therefore, an 
intermediate-term aggregate risk assessment was not performed.
    5. Aggregate cancer risk for U.S. population. Pyraflufen-ethyl has 
been classified as a ``likely to be carcinogenic to humans'' by the 
oral route of exposure (Q1* of 3.32 x 10-\2\ (mg/
kg/day)-\1\). Using the exposure assumptions discussed in 
this unit for cancer, the cancinogenic risk is determined for the U.S. 
population (total) only. The estimated exposure from food to 
pyraflufen-ethyl is 4.3 x 10-\5\ mg/kg/day. Applying the 
Q1* of 0.0332 (mg/kg/day)-\1\ to the exposure 
value results in a cancer risk estimate in the range of 1 in 1 million. 
This assessment substantially overstates risk because it is based on 
the assumption that all commodities covered by pyraflufen-ethyl 
tolerances contain tolerance level residues of pyraflufen-ethyl. 
Potential exposure from pyraflufen-ethyl in drinking water will, at 
most, only marginally increase dietary exposure. As the table below 
indicates, the DWLOC, estimated using a cancer risk of 3 in 1 million 
(considered to be in the range of 1 in 1 million), is not exceeded by 
estimated levels of pyraflufen-ethyl in drinking water.

[[Page 26310]]



            Table 3.--Cancer Drinking Water Levels of Comparison Calculations for the U.S. Population
----------------------------------------------------------------------------------------------------------------
                                                                Chronic       Ground      Surface
                                                  Negligible      Food        Water        Water        Cancer
              Q1* (mg/kg/day)-\1\                    Risk     Exposure mg/    EEC\2\       EEC\2\      DWLOC\3\
                                                   Level\1\      kg/day       (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
0.0332                                                3.0E-6       4.3E-5        0.002         0.28         1.65
----------------------------------------------------------------------------------------------------------------
\1\ 3.0E-6 is statistically within the range that EPA generally accepts as ``negligible risk.''
\2\ The crop producing the highest level was used (potatoes).
\3\ Cancer DWLOC (ppb) = maximum water exposure (mg/kg/day) x body weight (kg) / water consumption (L) x 10-\3\
  mg/[mu]g.

    6. 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 pyraflufen-ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Nichino America Incorporated has submitted a petition method 
validation (PMV) and an independent laboratory validation for a Gas 
Chromatography and Mass Selective (GC/MS) method proposed for the 
enforcement of tolerances for residues of pyraflufen-ethyl and its acid 
metabolite, E-1, on wheat.

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican limits, 
for residues of pyraflufen-ethyl in/on wheat. Harmonization is not an 
issue for this petition.

C. Conditions

    The following data are being required by the Agency to complete the 
database requirements prior to approval of an unconditional 
registration of pyraflufen-ethyl:
     Submit a separate copy of a detailed description of the 
methodology used to quantify residues of pyraflufen-ethyl and E-1 
(measured as E-15, the methyl ester of E-1) for this tolerance request 
without confidentiality claims. The results for E-15 should be 
calculated in terms of parent compound. Once the separate detailed 
description of the methodology is received and accepted, it will be 
sent to the Food and Drug Administration (FDA) for inclusion in the 
Pesticide Analytical Manual Volume II (PAM II) as a lettered method.

V. Conclusion

    Therefore, the tolerances are established for combined residues of 
pyraflufen-ethyl, (ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-
methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate) and its acid 
metabolite, E-1 (2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-
pyrazol-3-yl)-4- fluorophenoxyacetic acid), expressed as the ester 
equivalent, in or on wheat, forage and wheat, hay at 0.1 ppm; wheat, 
grain and wheat, straw at 0.01 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA 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) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-2004-0094 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 July 12, 
2004.
    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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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-
0001.
    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

[[Page 26311]]

Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    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 ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0094, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in ADDRESSES. 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. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: April 29, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

[[Page 26312]]

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.585 is amended by alphabetically adding commodities in 
the table in paragraph (a) to read as follows:


Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Wheat, forage..............................................          0.1
Wheat, grain...............................................         0.01
Wheat, hay.................................................          0.1
Wheat, straw...............................................         0.01
------------------------------------------------------------------------

* * * * *

[FR Doc. 04-10455 Filed 5-11-04; 8:45 am]
BILLING CODE 6560-50-S