Pyraflufen-ethyl (Nichino America). May 12, 2004. Pesticide tolerance. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Return to Pyraflufen-ethyl Index Page

Pyraflufen-ethyl (Nichino America). May 12, 2004. Pesticide Tolerance.
FINAL RULE. Federal Register.

Note from FAN: Pyraflufen-ethyl has been classified as a ``likely to be carcinogenic to humans'' by the oral route of exposure with a cancer risk estimate in the range of 1 in 1 million.

http://www.epa.gov/fedrgstr/EPA-PEST/2004/May/Day-12/p10455.htm

[Federal Register: May 12, 2004 (Volume 69, Number 92)]
[Rules and Regulations]
[Page 26305-26312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-6]
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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:
miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers; dairy cattle farmers; livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed 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
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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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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 (59 FR 22951, 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.
• Therefore, 40 CFR part 180 is amended as follows:
[[Page 26312]]
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 180.585 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