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Flufenpyr-ethyl (Valent).
September 19, 2003. Pesticide Tolerance. Final Rule.
Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/2003/September/Day-19/p24118.htm
[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Rules and Regulations]
[Page 54834-54843]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0166; FRL-7325-4]
Flufenpyr-Ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], in or on
field corn, soybeans, and sugarcane, and the combined residues of
flufenpyr-ethyl and its metabolite, S-3153 acid-4-OH; [2-chloro-4-
hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-
phenoxy]-acetic acid, free and conjugated, in or on field corn forage
and field corn stover. Valent USA Corporation requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act (FQPA) of 1996.
DATES: This regulation is effective September 19, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0166,
must be received on or before November 18, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
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 pest manufacturer.
Potentially affected
[[Page 54835]]
categories and entities may include, but are not limited to:
[sbull]
Crop production (NAICS 111)
[sbull]
Animal production (NAICS 112)
[sbull]
Food manufacturing (NAICS 311)
[sbull]
Pesticide manufacturing (NAICS 32532)
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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0166. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing 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.
2. Electronic access. 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 http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/4 
0cfr180--00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of June 25, 2003 (68 FR 37813) (FRL-7307-
8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (0F6164) by Valent USA Corporation, 1333 North
Carolina Blvd, Suite 600, P.O. Box 8025, Walnut Creek, CA 94596-8025.
That notice included a summary of the petition prepared by Valent USA
Corporation. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180 be amended by establishing
tolerances for flufenpyr-ethyl; ethyl[2-chloro-4-fluoro-5-(5-methyl-6-
oxo-4-trifluoromethyl-1,6-dihydropyridazin-1-yl)phenoxy]acetate, in or
on corn, field grain; soybean, seed; and sugarcane, cane at 0.01 parts
per million (ppm) and the combined residues of flufenpyr-ethyl and its
metabolite S-3153 acid 4-OH; [2-chloro-4-hydroxy-5-(5-methyl-6-oxo-4-
trifluoromethyl-1,6-dihydropyridazin-1-yl)phenoxy]-acetic acid in or on
corn, field, forage and corn, field, stover at 0.05 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of the 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 the 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 the FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of the 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 the FFDCA, for a tolerance for residues of the herbicide,
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester in or on
corn, field, grain; soybean, seed; and sugarcane, cane at 0.01 ppm and
the combined residues of flufenpyr-ethyl and its metabolite, 2-chloro-
4-hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-
phenoxy]-acetic acid, free and conjugated in or on corn, field, forage
and corn, field, stover at 0.05 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 flufenpyr-ethyl are
discussed in Table 1 of this unit as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.
[[Page 54836]]
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL >1,434/1,591
toxicity rodents milligrams/kilogram/
day (mg/kg/day) male/
female
LOAEL not identified
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL >1,195/1,378 mg/
toxicity in kg/day M/F
nonrodents LOAEL not identified
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 395 mg/kg/day
toxicity rodents (M)
(mouse) LOAEL = 908 mg/kg/
day, based on
increased absolute
and relative liver
weights and
increased incidence
of hepatic
centrilobular
vacuolation in male
mice
------------------------------------------------------------------------
870.3100 28-Day oral NOAEL = 448/629 mg/kg/
toxicity rodents day M/F
(mouse) LOAEL = 1,009/1,213 M/
F mg/kg/day, based
on increased
incidence of hepatic
centrilobular
vacuolation
------------------------------------------------------------------------
870.3150 90-Day oral NOAEL = 300 mg/kg/day
toxicity in non/ M/F
rodents (dog) LOAEL = 1,000 M/F mg/
kg/day, based on
decreased body
weight gains, food
consumption, and
food efficiency and
increased incidence
of vomiting
------------------------------------------------------------------------
870.3200 21-Day dermal NOAEL = 1,000 mg/kg/
toxicity (rat) day M/F
LOAEL not identified
------------------------------------------------------------------------
870.3250 90-Day dermal NA
toxicity
------------------------------------------------------------------------
870.3465 90-Day inhalation NA
toxicity
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental in NOAEL >1,000 mg/kg/
rodents (rat) day
LOAEL was not
established
Developmental
NOAEL = 1,000 mg/kg/
day highest dose
tested (HDT)
LOAEL not identified
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental in NOAEL = 100 mg/kg/day
nonrodents LOAEL = 300 mg/kg/
(rabbit) day, based on
increased maternal
mortality, clinical
signs, decreased
food consumption and
necropsy findings
Developmental
NOAEL = 1,000 mg/kg/
day
LOAEL not identified
------------------------------------------------------------------------
870.3700 Prenatal Maternal
developmental in NOAEL = 100 mg/kg/day
nonrodents LOAEL = 200 mg/kg/
(rabbit) day, based on
increased mortality
Developmental
NOAEL = 1,000 mg/kg/
day HDT
LOAEL not identified
------------------------------------------------------------------------
870.3800 2-Generation Parental/systemic
reproduction and NOAEL = 1,463 - 1,914
fertility mg/kg/day
effects (rat) LOAEL not identified
Reproductive
NOAEL = 1,463 - 1,914
mg/kg/day
LOAEL not identified
Offspring
NOAEL = 1,463 - 1,914
mg/kg/day
LOAEL not identified
------------------------------------------------------------------------
870.3800 1-Generation Parental/systemic
reproduction and NOAEL = 6.4 - 7.5 mg/
fertility kg/day
effects (rat) LOAEL not identified
Reproductive
NOAEL = 6.4 - 7.5 mg/
kg/day
LOAEL not identified
Offspring
NOAEL = 6.4 - 7.5 mg/
kg/day
LOAEL not identified
------------------------------------------------------------------------
[[Page 54837]]
870.3800 1-Generation Parental/systemic
reproduction and NOAEL = 139.4 - 151.7
fertility mg/kg/day
effects (rat) LOAEL not identified
Reproductive
NOAEL = 139.4 - 151.7
mg/kg/day
LOAEL not identified
Offspring
NOAEL = 139.4 - 151.7
mg/kg/day
LOAEL not identified
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 778.8/1024.7
toxicity/ mg/kg/day M/F
carcinogenicity LOAEL was not
rodents (rat) established
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4200 Carcinogenicity NOAEL = 39.9 - 43.7
rodents (mouse) mg/kg/day M/F
LOAEL = 401.8 - 447.9
mg/kg/day M/F, based
on liver toxicity in
both sexes and mild
anemia in males
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5100 Bacterial gene Flufenpyr-ethyl was
mutation assay tested up to
concentrations
limited by
cytotoxicity. There
was no evidence of
mutagenicity at any
dose levels tested.
Positive controls
induced appropriate
response
------------------------------------------------------------------------
870.5100 Bacterial gene There was no evidence
mutation assay of a cytotoxic,
S-3153 acid-4-OH. mutagenic or dose-
response trend in
any tester system +/-
S9. Positive
controls induced
appropriate response
------------------------------------------------------------------------
870.5300 In vitro The compound was
mammalian cell tested up to an
gene mutation upper concentration
assay limited by
solubility and
cytotoxicity.
Flufenpyr-ethyl was
negative for
inducing mutations
at the TK locus in
mouse L5178Y +/- S9
------------------------------------------------------------------------
870.5395 Mammalian No clinical signs of
erythrocyte toxicity was
micronucleus observed. Flufenpyr-
assay ethyl did not induce
micronucleated
polychromatic
erythrocytes after
any treatment
------------------------------------------------------------------------
870.7485 Metabolism and There is no
pharmacokinetics difference in the
- rat metabolic profile of
flufenpyr-ethyl
attributable to
gender or radiolabel
position
------------------------------------------------------------------------
B. Toxicological Endpoints
The dose at which no observed adverse effects levels (the NOAEL)
from the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by the appropriate UF (RfD =
NOAEL/UF). Where an additional safety factors (SF) is retained due to
concerns unique to the FQPA, this additional factor is applied to the
RfD by dividing the RfD by such additional factor. The acute or chronic
Population Adjusted Dose (aPAD) or (cPAD) is a modification of the RfD
to accommodate this type of FQPA SF.
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 is expressed as 1 x 10-6 or one in a million).
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 (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for flufenpyr-ethyl used for human risk assessment is shown
in the following Table 2:
[[Page 54838]]
Table 2.-Summary of Toxicological Dose and Endpoints for Flufenpyr-ethyl for Use in Human Health Risk
Assessment1
----------------------------------------------------------------------------------------------------------------
Special FQPA SF2 and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (females 13-50 years of NOAEL = None mg/kg/day Special FQPA SF = 1x A dose and endpoint of
age) UF = N/A............... aPAD = acute RfD....... concern attributable
Acute RfD = None....... Special FQPA SF = None. to a single dose was
not available in the
data base including
the developmental
toxicity studies
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population NOAEL = None mg/kg/day FQPA SF = 1x A dose and endpoint of
including infants and children) UF = N/A............... aPAD = acute RfD....... concern attributable
Acute RfD = None....... Special FQPA SF = None. to a single dose was
not available in the
data base including
the developmental
toxicity studies
----------------------------------------------------------------------------------------------------------------
Chronic dietary (all populations) NOAEL = 40 mg/kg/day Special FQPA SF = 1x Carcinogenicity study -
UF = 100............... cPAD = chronic RfD..... mice
Chronic RfD = 0.4 mg/kg/ Special FQPA SF = 0.4 LOAEL = 401.8 mg/kg/day
day. mg/kg/day. based on liver
toxicity (hepatocyte
necrosis) in both
sexes and mild anemia
in males
----------------------------------------------------------------------------------------------------------------
Short-term NOAEL = 100 mg/kg/day Residential LOC for MOE Developmental toxicity
Incidental oral (1-30 days).......... = 100 study - rabbit
Occupational = NA...... LOAEL = 300 mg/kg/day,
based on clinical
signs, decreased food
consumption and
necropsy findings
----------------------------------------------------------------------------------------------------------------
Intermediate-term NOAEL = 100 mg/kg/day Residential LOC for MOE Developmental toxicity
Incidental oral (1-6 months)......... = 100 study - rabbit
Occupational = NA...... LOAEL = 300 mg/kg/day,
based on clinical
signs, decreased food
consumption and
necropsy findings
----------------------------------------------------------------------------------------------------------------
Dermal all durations HIARC concluded quantitation of dermal risk is not required due to lack
of systemic toxicity at the limit-dose following repeated dermal
exposures as well as lack of concern for developmental toxicity
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1-30 days) NOAEL = 40 mg/kg/day Residential LOC for MOE Carcinogenicity study -
(inhalation absorption = 100 mice
rate = 100%). Occupational LOC for LOAEL = 401.8 mg/kg/day
MOE = 100. based on liver
toxicity (hepatocyte
necrosis) in both
sexes and mild anemia
in males
----------------------------------------------------------------------------------------------------------------
Intermediate-term inhalation (1-6 NOAEL = 40 mg/kg/day Residential LOC for Carcinogenicity study -
months) (inhalation absorption MOE = 100 mice
rate = 100%). Occupational LOC for LOAEL = 401.8 mg/kg/day
MOE = 100. based on liver
toxicity (hepatocyte
necrosis) in both
sexes and mild anemia
in males
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (>6 months) NOAEL = 40 mg/kg/day Residential LOC for MOE Carcinogenicity study -
(inhalation absorption = 100 mice
rate = 100%). Occupational LOC for LOAEL = 401.8 mg/kg/day
MOE = 100. based on liver
toxicity (hepatocyte
necrosis) in both
sexes and mild anemia
in males
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Flufenpyr-ethyl classified as ``not likely to be carcinogenic to
humans.''
----------------------------------------------------------------------------------------------------------------
1 UF = uncertainty factor, FQPA SF = Special FQPA safety factor, MOE = margin of exposure, LOC = level of
concern, NA = Not Applicable.
2 The reference to the Special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. No tolerances have
been previously established for the residues and the combined residues
of flufenpyr-ethyl, in or on raw agricultural commodities. Risk
assessments were conducted by EPA to assess dietary exposures from
flufenpyr-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 1-day or
single exposure. An endpoint of concern attributable to a single oral
dose was not identified for either the general U.S. population
(including infants and children) and all population subgroups, or the
females 13-50 years old population subgroup for flufenpyr-ethyl;
therefore, an acute dietary exposure analysis was not performed.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEMTM)
analysis evaluated the individual food consumption 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: An unrefined, chronic dietary exposure assessment was
conducted for the general U.S. population and various population
subgroups. Proposed tolerance-level residues and 100 percent crop
treated (%CT) information were used for all
[[Page 54839]]
proposed commodities. The submitted corn grain, soybean, and sugarcane
processing studies indicate that flufenpyr-ethyl residues do not
concentrate in corn, soybean, and sugarcane processed commodities.
Therefore, processing factors were set to 1 for all corn, soybean, and
sugarcane processed commodities.
The chronic dietary exposure estimates are below EPA's level of
concern (<100% cPAD) for the general U.S. population and all population
subgroups (<1% of the cPAD). The chronic assessment was highly
conservative, using several upper-end assumptions. Additional
refinements, such as inclusion of anticipated residues (ARs) and %CT
data, could be made in order to refine the chronic assessment.
iii. Cancer. A quantitative cancer aggregate risk assessment was
not performed because flufenpyr-ethyl is classified as ``not likely''
to be carcinogenic based on lack of evidence of carcinogenicity in mice
and rats.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flufenpyr-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 physical
characteristics of flufenpyr-ethyl.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produce estimates of pesticide concentrations in an index reservoir.
The Screening Concentration in Groundwater (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. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop (PC) area factor as an adjustment to account for the maximum PC
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 coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever 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) from these models to quantify
drinking water exposure and risk as a percent reference dose (%RfD) or
percent population adjusted dose (%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.
Based on FIRST and SCI-GROW models, the EECs of flufenpyr-ethyl and
its metabolite S-3153 acid 4-OH for acute exposures are estimated to be
3.76 parts per billion (ppb) for surface water and 0.05 ppb for ground
water. The EECs for chronic exposures are estimated to be 1.504 ppb for
surface water and 0.05 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).
Flufenpyr-ethyl is not registered for use on any sites that would
result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether flufenpyr-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 flufenpyr-
ethyl and any other substances, and flufenpyr-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
flufenpyr-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
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
D. Safety Factor for Infants and Children
1. In general. Section 408 of the 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 that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. There is no evidence of
quantitative and/or qualitative evidence of increased susceptibility of
rat and rabbit fetuses to in utero exposure to flufenpyr-ethyl. There
is no evidence of increased qualitative and/or quantitative evidence of
increased susceptibility to flufenpyr-ethyl following prenatal exposure
in a 2-generation reproduction study(s) in rats or 1-generation
reproduction studies.
3. Conclusion. There is a complete toxicity data base for
flufenpyr-ethyl and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures.
The FQPA Safety Factor (SF) was reduced to 1x based on
toxicological considerations, the conservative residue assumptions used
in the chronic dietary exposure risk assessment, the completeness of
the toxicity, residue chemistry and environmental fate data base and
the lack of the potential for residential exposures.
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 the model
[[Page 54840]]
estimates of a pesticide's concentration in water (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 U.S. EPA 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, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA 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, EPA 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 endpoint of concern attributable to a single oral
dose was identified for either the general U.S. population (including
infants and children) or females 13-50 years old population subgroup.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flufenpyr-ethyl from food will utilize less than 1% of the cPAD for the
U.S. population, less than 1% of the cPAD for all infants less than 1
year old and less than 1% of the cPAD for for children 3-5 years old.
There are no residential uses for flufenpyr-ethyl that result in
chronic residential exposure to flufenpyr-ethyl.
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Flufenpyr-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ %cPAD Water EEC Water EEC Chronic DWLOC2 ([mu]g/
kg) (Food) (ppb) (ppb) L)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.4 <1% 2.0 0.07 14,000
----------------------------------------------------------------------------------------------------------------
All infants (<1 year old) 0.4 <1% 2.0 0.07 4,000
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old) 0.4 <1% 2.0 0.07 4,000
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old) 0.4 <1% 2.0 0.07 4,000
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old) 0.4 <1% 2.0 0.07 4,000
----------------------------------------------------------------------------------------------------------------
Youth (13-19 years old) 0.4 <1% 2.0 0.07 12,000
----------------------------------------------------------------------------------------------------------------
Adults (20-49 years old) 0.4 <1% 2.0 0.07 14,000
----------------------------------------------------------------------------------------------------------------
Females (13-49 years old) 0.4 <1% 2.0 0.07 12,000
----------------------------------------------------------------------------------------------------------------
Adults (50+ years old) 0.4 <1% 2.0 0.07 14,000
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate risk assessment was not
performed because there are no registered or proposed residential non-
food uses. Flufenpyr-ethyl is not registered for use on any sites that
would result in residential exposure. Therefore, the aggregate risk is
the sum of the risk from food and water, which do not exceed the
Agency's level of concern.
4. Intermediate-term risk. Intermediate-term aggregate risk
assessment was not performed because there are no registered or
proposed residential non-food uses. Flufenpyr-ethyl is not registered
for use on any sites that would result in residential exposure.
Therefore, the aggregate risk is the sum of the risk from food and
water, which do not exceed the Agency's level of concern.
5. Aggregate cancer risk for U.S. population. Flufenpyr-ethyl is
not carcinogenic.
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 flufenpyr-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The Agency has a method (Method RM-36-1) for determination of
flufenpyr-ethyl per se and a method (Method RM-36-3c) for determination
for free and conjugated S-3153 acid-4-OH. An enforcement (confirmatory)
method capable of measuring both parent and metabolite is being
requested by the Agency.
B. International Residue Limits
There are currently no established tolerances for residues of
flufenpyr-ethyl in/on any plant or livestock commodities. As there are
no Mexican, Canadian or Codex maximum residue limits established for
flufenpyr-ethyl in/on field corn, soybeans and sugarcane, there are no
compatibility issues to be reconciled.
C. Conditions
Confirmatory storage stability data for the metabolite S-3153 acid-
4-OH in field corn forage and stover and an
[[Page 54841]]
enforcement method for measuring both parent and metabolite are
required.
V. Conclusion
Therefore, the tolerance is established for residues of the
herbicide flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-
6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester, in
or on: Corn, field, grain; soybean, seed; and sugarcane, cane at 0.01
ppm and the combined residues of the herbicide; flufenpyr-ethyl; acetic
acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-
pyridazinyl]-phenoxy]-ethyl ester, and its metabolite, S-3153 acid- 4-
OH; [2-chloro-4-hydroxy-5-[5-methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-
pyridazinyl]-phenoxy]-acetic acid, free and conjugated in/on: Corn,
field, forage; and corn, field, stover at 0.05 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the 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 the 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-2003-0166 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 November
18, 2003.
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
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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0166, 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 Unit I.B.1. 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 the
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
[[Page 54842]]
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 the 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 the 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: September 15, 2003.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180-- [AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
0
2. Section 180.595 is added to read as follows:
Sec. 180.595 Flufenpyr-ethyl; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
herbicide, flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-
methyl-6-oxo-4-(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl
ester], in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Corn, field, grain.................. 0.01
Soybean, seed....................... 0.01
Sugarcane, cane..................... 0.01
------------------------------------------------------------------------
(2) Tolerances are established for residues of the herbicide
flufenpyr-ethyl; acetic acid, [2-chloro-4-fluoro-5-[5-methyl-6-oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-ethyl ester], and its
metabolite, S-3153 acid-4-OH; [2-chloro-4-hydroxy-5-[5-methyl-6- oxo-4-
(trifluoromethyl)-1-(6H)-pyridazinyl]-phenoxy]-acetic acid, free and
conjugated, in or on the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Corn, field, forage................. 0.05
Corn, field, stover................. 0.05
------------------------------------------------------------------------
[[Page 54843]]
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 03-24118 Filed 9-17-03; 1:38 pm]
BILLING CODE 6560-50-S