[Federal Register: February 16, 2005 (Volume 70, Number 31)]
[Rules and Regulations]
[Page 7864-7870]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe05-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0324; FRL-7694-4]
Quizalofop-ethyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of quizalofop (2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoic
acid) and quizalofop ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-yl
oxy)phenoxy]propanoate, all expressed as quizalofop ethyl in or on
bean, dry; bean, succulent; beet, sugar, roots; beet, sugar, tops;
cowpea, forage; cowpea, hay; peas, dry; pea, field, hay; pea, field,
vines; and pea, succulent. Also a tolerance for the combined residues
of quizalofop-p-ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate) and its acid metabolite quizalofop-p (R-(2-
(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid)), and the S
enantiomers of both the ester and the acid, all expressed as
quizalofop-p-ethyl ester is established for beet, sugar, molasses. E.
I. DuPont de Nemours and Company 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 February 16, 2005. Objections and
requests for hearings must be received on or before April 18, 2005.
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
identification (ID) number OPP-2004-0324. 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, 1801 S.
Bell St., 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: James A. Tompkins, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5697; e-mail
address:tompkins.jim@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
[[Page 7865]]
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/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
In the Federal Register of August 25, 2004 (69 FR 52256) (FRL-7372-
4), 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
3F4268) by E. I. DuPont de Nemours and Company, Laurel Run, Wilmington,
DE 19880-0038. The petition requested that 40 CFR 180.441(a)(1) be
amended by establishing a tolerance for residues of the herbicide
quizalofop (2-[4-(6-chloroquinoxalin-2-yl oxy)phenoxy]propanoic acid)
and quizalofop ethyl (ethyl-2-[4-(6-chloroquinqaxalin-2-yl
oxy)phenoxy]propanoate), all expressed as quizalofop ethyl (DuPont
Assure II) in or on the raw agricultural commodities, dry beans at 0.4
parts per million (ppm); dry bean straw at 3.0 ppm; succulent beans at
0.25 ppm; succulent bean forage at 3.0 ppm; dry peas at 0.25; dry pea
straw at 3.0 ppm; succulent peas at 0.3 ppm; succulent pea forage at
3.0 ppm; sugar beet root at 0.1 ppm; sugar beet top at 0.5 ppm; and
Sec. 180.441(a)(3) by establishing a permanent tolerance for sugar
beet molasses at 0.2 ppm. These proposed tolerances replace the time-
limited tolerances listed in Sec. 180.441(a)(4). That notice included
a summary of the petition prepared by E.I. Dupont de Nemours and
Company, the registrant. There was one comment received in response to
this notice of filing. The commenter objected to all approvals of this
chemical. The commenter further opposed all exemptions, waivers,
residues on food and in soil/water or any plant. The commenter also
objected to testing on cows, rabbits, and dogs and to the residues in
milk. This comment will be further discussed in Unit V. of this
document.
During the course of the review it was determined that the
commodity listing in the notice of filing was not consistent with
current terminology. Therefore, these corrections are being made at
this time. The proposed commodity language for 40 CFR 180.441(a)(1) is
beans, dry at 0.4 ppm; bean, succulent at 0.25 ppm; beet, sugar, roots
at 0.1 ppm; beet, sugar, tops at 0.5 ppm; cowpea, forage at 3.0 ppm;
cowpea, hay at 3.0 ppm; pea, dry at 0.25 ppm; pea, field, hay at 3.0
ppm; pea, field vines at 3.0 ppm; and pea, succulent at 0.3 ppm. The
commodities dry bean straw, succulent bean forage, dry pea straw, and
succulent pea forage are replaced by the commodities cowpea, hay;
cowpea, forage; pea. field, hay; and pea, field, vines; respectively.
Similarly, the proposed commodity language for Sec. 180.441(a)(3) is
beet, sugar, molasses. These tolerances replace the time-limited
tolerances listed in Sec. 180.441(a)(4).
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 a tolerance for combined residues of quizalofop
(2-[4-(6- chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid) and
quizalofop ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate), all expressed as quizalofop-ethyl in or on
the agricultural commodities beans, dry at 0.4 ppm; bean, succulent at
0.25 ppm; beet, sugar, roots at 0.1 ppm; beet, sugar, tops at 0.5 ppm;
cowpea, forage at 3.0 ppm; cowpea, hay at 3.0 ppm; pea, dry at 0.25
ppm; pea, field, hay at 3.0 ppm; pea, field vines at 3.0 ppm; and pea,
succulent at 0.3 ppm and quizalofop-p-ethyl ester (ethyl (R)-(2-(4-((6-
chloroquinoxalin-2-yl)oxy)phenoxy)propanoate) and its acid metabolite
quizalofop-p (R-(2-(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic
acid)), and the S enantiomers of both the ester and the acid, all
expressed as quizalofop-p-ethyl ester in or on the commodity beet,
sugar, molasses at 0.2 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 quizalofop-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 June 16, 1998 (63 FR
32753) (FRL-5793-5).
B. Toxicological Endpoints
The dose at which 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 LOAEL is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An
[[Page 7866]]
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 UF''; the ``special FQPA safety factor''; and the
``default FQPA safety factor.'' By the term ``traditional UF'', EPA is
referring to those additional UFs used prior to FQPA passage to account
for database deficiencies. These traditional UFs 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
UF 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 (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by an UF of 100 to account for
interspecies and intraspecies differences and any traditional UFs
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
(MOEcancer =point of departure/exposures) is calculated.
A summary of the toxicological endpoints for quizalofop-ethyl used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of June 16, 1998 (63 FR 32753) (FRL-
5793-5).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.441) for the combined residues of quizalofop-
ethyl, quizalofop-p-ethyl and associated metabolites, in or on a
variety of raw agricultural commodities. Tolerances are established
under Sec. 180.441(a)(2) for quizalofop, quizalofop-ethyl, and
quizalofop methyl (methyl 2-[4-(6-oxy)phenoxy]propanoate) all expressed
as quizalofop-ethyl in or on meat, fat, and meat by products of cattle,
goat, hog, horse, poultry, and sheep; milk and milk fat; and egg. Risk
assessments were conducted by EPA to assess dietary exposures from
quizalofop 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. There were no effects observed in the toxicology data
base that could be attributable to a single dose (exposure). Therefore
an acute dietary exposure analysis was not performed.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the Dietary Exposure Evaluation Model
(DEEMTM) software with the Food Commodity Intake Database
(FCID), which incorporates food consumption data as reported by
respondents in the United States 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: Tolerance level residues, DEEMTM default
factors, and 100% crop treated. Data on percent of the crop treated or
anticipated residues were not used.
iii. Cancer. EPA concluded that the pesticidal use of quizalofop-
ethyl is not classifiable as to human carcinogenicity. Therefore, a
quantitative cancer exposure assessment was not performed. Refer to
Unit II.B.4. in the Federal Register of June 16, 1998 (63 FR 32753)
(FRL-5793-5) for a detailed discussion.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for quizalofop-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 quizalofop-ethyl.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) to estimate pesticide concentrations in surface
water and SCI-GROW, which predicts pesticide concentrations in ground
water. In general, EPA will use GENEEC (a Tier 1 model) before using
PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for
surface water. The GENEEC model is a subset of the PRZM/EXAMS model
that uses a specific high-end runoff scenario for pesticides. GENEEC
incorporates a farm pond scenario, while PRZM/EXAMS incorporates an
index reservoir environment in place of the previous pond scenario. 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 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
[[Page 7867]]
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 quizalofop-ethyl, they are
further discussed in Unit III.E.
Based on the GENEEC and SCI-GROW models, the EECs of quizalofop-
ethyl for chronic exposures are estimated to be 8.08 ppb for surface
water and 0.15 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).
Quizalofop-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 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.''
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 quizalofop-ethyl and any
other substances and quizalofop-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 quizalofop-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 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 (MOS) 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. The histopathology data for
F2 weanlings in the 2-generation reproductive toxicity study suggested
an increased sensitivity to the offspring. In that study, an increase
in the incidence of eosinophilic changes in the liver were noted in the
F2 weanlings, and the offspring no observed effect level (NOEL) was
less than the parental systemic NOEL. However, the significance of
these observations in the 2-generation reproductive toxicity study is
rendered questionable due to: (i) The changes in the weanling liver
were not well characterized; (ii) the biological significance of this
endpoint was not known; (iii) the precise dose of test substance to 21-
day old weanlings cannot be determined with any accuracy, but it is
likely to exceed that of the adults; (iv) this endpoint (eosinophilic
changes), in adults, would not be considered appropriate for use in
regulation of a chemical because of the questionable biological
significance of this effect; and, (v) previous toxicological studies
show the liver as the target organ in rats. No particular significance
to the offspring is attributed to the liver effects. Developmental
toxicity studies showed no increased sensitivity in pups as compared to
maternal animals following in utero exposures to rats and rabbits.
3. Conclusion. There is a complete toxicity data base for
quizalofop-ethyl and exposure data are complete or are estimated based
on data that reasonably accounts for potential exposures. The impact of
quizalofop-ethyl on the nervous system has not been specifically
evaluated in neurotoxicity studies. A developmental neurotoxicity study
is not required for quizalofop-ethyl based on the following: (i)
Quizalofop-ethyl does not appear to be a neurotoxic chemical; (ii) no-
treatment-related effects on brain weight or histopathology (non-
perfused) of the nervous system was observed in studies that measured
these endpoints; (iii) no evidence of developmental anomalites of the
fetal nervous system were observed in either rats or rabbits, at
maternally toxic oral doses up to 300 and 600 mg/kg/day, respectively,
and; (iv) no evidence of an effect on functional development was
observed in a postnatal segment of the developmental toxicity study in
rats. EPA determined that the 10X SF to protect infants and children
should be removed. The FQPA factor is removed because the toxicology
data base is complete; a developmental neurotoxicity study is not
required; developmental toxicity studies showed no increased
sensitivity in fetuses as compared to maternal animals following in
utero exposures in rats and rabbits; and a 2-generation reproduction
study showed no increased sensitivity in pups as compared to adults.
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 milligrams/
kilogram/day (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 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
[[Page 7868]]
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. Quizalofop-ethyl is not expected to pose an acute
risk because no toxicological endpoints attributable to a single
exposure (dose) were identified in the toxicology data base.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
quizalofop-ethyl from food will utilize 3.0% of the cPAD for the U.S.
population, 3.4% of the cPAD for all infants (< 1 year old), and 9.6%
of the cPAD for children 1-2 years old. There are no residential uses
for quizalofop-ethyl that result in chronic residential exposure to
quizalofop-ethyl. In addition, there is potential for chronic dietary
exposure to quizalofop-ethyl in drinking water. After calculating
DWLOCs and comparing them to the EECs for surface water and ground
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD, as shown in the following Table 1.
Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Quizalofop-ethyl
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.009 3.0 8.08 0.15 306
------------------------------------------------ < 1 year
------------------------------------------------
--------------------------------------------------------------
--------------------------------------------------------------
--------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Quizalofop-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 exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Quizalofop-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. Quizalofop-ethyl is
classified as ``not classifiable as to human cancer potential.'' The
Agency believes that any cancer risk posed by quizalofop-ethyl is
negligible and there is reasonable certainty that no harm will result
form exposure to residue of quizalofop-ethyl. Refer to the Federal
Register of June 16, 1998 (63 FR 32753) (FRL-5793-5) for a detailed
discussion.
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 quizalofop-ethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate analytical methodology (high pressure liquid
chromatography (HPLC) using either an ultraviolet or fluorescence
detector is available for enforcement purposes in Vol II of the Food
and Drug Administration (FDA) Pesticide Analytical Method (PAM II,
Method I).
B. International Residue Limits
Since there are no Mexican or Canadian Maximum Residue Levels,
compatibility is not a problem at this time. Compatibility cannot be
achieved with the Canadian negligible residue type limit of 0.1 ppm,
since data supporting United States use patterns had findings of real
residues above 0.1 ppm.
C. Conditions
There are no conditions of registration for establishment of
tolerances on the commodities bean, dry; bean, succulent; cowpea,
forage; cowpea, hay; beet, sugar, molasses; beet, sugar, roots; beet,
sugar, tops; pea, dry; pea, field, hay; pea, field, vines; and pea,
succulent.
V. Comment
One comment was received in response to the notice of filing. The
commenter objected to all approvals of any kind for this pesticide and
objected to all exemptions, waivers, residues on food, milk, or on
soil/water or any plants. The commenter also objected to animal testing
on cows, rabbits, or dogs, because animal testing constitutes animal
abuse and stated that it should be stopped. The commenter also stated
that more modern less abusive methods should be used.
The comment contained no scientific data or evidence to rebut the
Agency's conclusion that there is a reasonable certainty that no harm
will result from the aggregate exposure to quizalofop-ethyl, including
all anticipated dietary exposure and all other exposures for which
there is reliable information.
[[Page 7869]]
OPPTS Harmonized Guideline--Health Effects Guidelines (Series 870)
recommend that dog or rabbit be used for various acute, subchronic, and
longer term chronic, carcinogenic, developmental, and reproductive
studies. Residue Chemistry Guidelines (Series 860) recommend that a cow
be used for certain feeding studies. Information derived from these
tests indicate the presence of possible hazards or residues from
exposure to the test substance. Currently, there are no in vitro
studies that can address the questions that these studies answer. The
Agency is currently working with the Interagency Coordinating Committee
on the Validation or Alternate Methods to investigate alternative in
vitro methods.
VI. Conclusion
Therefore, permanent tolerances are established for combined
residues of quizalofop (2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)-
propanoic acid) and quizalofop ethyl (ethyl-2-[4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate), all expressed as quizalofop ethyl in or on
bean, dry at 0.4 ppm; bean, succulent at 0.25; beet, sugar, roots at
0.1 ppm; beet, sugar, tops at 0.5 ppm; cowpea, forage at 3.0 ppm;
cowpea, hay at 3.0 ppm; pea, dry at 0.25 ppm; pea, field, hay at 3.0
ppm; pea, field, vines at 3.0 ppm; and pea, succulent at 0.3 ppm (40
CFR 180.441(a)(1)). Also, 40 CFR 180.441(a)(3) is amended by
establishing a permanent tolerance for the combined residues of
quizalofop-p-ethyl ester (ethyl (R)-(2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate)) and its acid metabolite quizalofop-p R-(2-
(4-((6-chloroquinoxalin-2-yl)oxy)phenoxy)propanoic acid), and the S
enantiomers of both the ester and the acid, all expressed as
quizalofop-p-ethyl ester is established for beet, sugar, molasses at
0.2 ppm. These tolerances replace the ones listed in 40 CFR
180.441(a)(4).
VII. 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-2004-0324 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 April 18,
2005.
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 (1900L),
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 Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. 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-2004-0324, 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).
VIII. 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
[[Page 7870]]
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Since tolerances and exemptions that are
established on the basis of a petition under section 408(d) of FFDCA,
such as the tolerance in this final rule, do not require the issuance
of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
IX. 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: February 7, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.441 is amended by adding alphabetically the following
commodities to the table in paragraph (a)(1) and (a)(3) to read as
follows:
Sec. 180.441 Quizalofop-ethyl; tolerances for residues.
(a)(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, dry.................................................. 0.4
Bean, succulent............................................ 0.25
Beet, sugar, roots......................................... 0.1
Beet, sugar, tops.......................................... 0.5
Cowpea, forage............................................. 3.0
Cowpea, hay................................................ 3.0
Pea, dry................................................... 0.25
Pea, field, hay............................................ 3.0
Pea, field, vines.......................................... 3.0>
Pea, succulent............................................. 0.3
* * * * *
------------------------------------------------------------------------
* * * * *
(3) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Beet, sugar, molasses...................................... 0.2 ppm
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 05-2982 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S