[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Rules and Regulations]
[Pages 7864-7870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2982]


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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:[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American

[[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: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

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