Ethalfluralin (IR-4). Jan 17, 2002. Pesticide tolerance of 0.05 ppm in or on Canola and Safflower seed. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Ethalfluralin (IR-4). January 17, 2002. Pesticide Tolerance of 0.05 ppm in or on Canola and Safflower seed. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2002/January/Day-17/p701.htm

[Federal Register: January 17, 2002 (Volume 67, Number 12)]
[Rules and Regulations]
[Page 2333-2343]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ja02-10]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301208; FRL-6818-6]
RIN 2070-AB78

Ethalfluralin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
ethalfluralin in or on canola seed and safflower seed. IR-4 requested
these tolerances 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 January 17, 2002. Objections and
requests for hearings, identified by docket control number OPP-301208,
must be received by EPA on or before March 18, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301208 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460;
telephone number: (703) 308-9368; and e-mail address:
Jamerson.Hoyt@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

[[Page 2334]]

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to 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_40/40cfr180_00.html , a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301208. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of November 14, 2001 (66 FR 57082) (FRL-
6808-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a as amended by the FQPA (Public Law 104-170) announcing the
filing of pesticide petitions (PP 9E5037, 1E6326, and 1E6345) for
tolerances by Interregional Research Project Number 4 (IR-4), 681 U.S.
Highway Number 1, South, North Brunswick, New Jersey 08902-3390. This
notice included a summary of the petitions prepared by Dow
AgroSciences, the registrant. There were no comments received in
response to the notice of filing.
The petitions requested that 40 CFR 180.416 be amended by
establishing tolerances for residues of the herbicide ethalfluralin,
[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl)benzenamine, in or on canola seed and safflower seed
at 0.05 part per million (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) 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)
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 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), 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), for tolerances for residues of ethalfluralin on canola seed
and safflower seed at 0.05 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerances 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 ethalfluralin are
discussed in the following Table 1 as well as the no observed adverse
effect level (NOAEL) and the lowest observed adverse effect level
(LOAEL) from the toxicity studies reviewed.

Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 68 mg/kg/
toxicity rodents day
LOAEL = 136 mg/kg/
day based on low
bilirubin and low
kidney weights in males.
------------------------------------------------------------------------

[[Page 2335]]

870.3150 90-Day oral NOAEL = 27.5 mg/kg/
toxicity in day
nonrodents LOAEL = 80 mg/kg/
day based on
elevated alkaline
phosphatase,
slight fatty
metamorphosis of
the liver,
increase
cholesterol, and
increased blood
urea nitrogen
(BUN).
------------------------------------------------------------------------
870.3200 21-Day dermal NOAEL = 1,000 mg/
toxicity in kg/day - highest
rabbits dose tested (HDT)
LOAEL =>1,000 mg/
kg/day no
systemic effects
were seen at the
HDT.
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 50 mg/kg/day
rodents LOAEL = 250 mg/kg/
day based on
decreased body
weight gain and
dark urine.
Developmental
NOAEL = 1,000 mg/
kg/day no
systemic effects
were seen at the
HDT.
LOAEL = >1,000 mg/
kg/day no
systemic effects
were seen at the
HDT.
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 75 mg/kg/day
nonrodents LOAEL = 150 mg/kg/
day based on
abortions and
decreased food
consumption.
Developmental
NOAEL = 75 mg/kg/
dayLOAEL = 150 mg/
kg/day based on
slightly
increased
resorptions,
abnormal cranial
development, and
increase sternal
variants.
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = 12.5 mg/
in rats kg/day
LOAEL = 37.5 mg/kg/
day based on
decreased mean
body weight gains
in males in all
generations.
Reproductive NOAEL
= 37.5 mg/kg/day
HDT
LOAEL = >37.5 mg/
kg/day no
systemic effects
were seen at the
HDT.
------------------------------------------------------------------------
870.4100 Chronic toxicity NOAEL = 4 mg/kg/
dogs day
LOAEL = 20 mg/kg/
day based on
increased urinary
bilirubin,
variations in
erythrocyte
morphology,
increased
thrombocyte
count, and
increased
erythroid series
of the bone
marrow.
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 32.3 mg/kg/
toxicity/ day HDT
carcinogenicity LOAEL = > 32.3 mg/
in rats kg/day no
systemic effects
were seen at the
HDT.
Mammary gland
fibroadenomas
were found in
dosed female rats
at statistically
significant
incidences in mid
and high doses.
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 10.3 mg/kg/
toxicity/ day
carcinogenicity LOAEL = 41.9 mg/kg/
in mice day based on
focal
hepatocellular
hyperplasia in
both sexes and
increased liver,
kidney, and heart
weights in
females.
No increase in of
neoplasms was
attributed to the
treatment.
------------------------------------------------------------------------
870.5100 Bacterial reverse Ethalfluralin was
mutation test weakly mutagenic
in activated
strains TA1535
and TA100 of
Salmonella
typhimurium, but
not in strains
TA1537, TA1538,
and TA98 in an
Ames assay. In a
modified Ames
assay with
Salmonella
typhimurium and
Escherichia coli,
ethalfluralin was
weakly mutagenic
in strains TA1535
and TA100, with
and without
activation, and
in strain TA 98
without
activation, at
the highest dose.
------------------------------------------------------------------------
870.5300 In vitro mammalian No mutagenicity
cell mutation was found in the
test mouse lymphoma
assay for forward
mutation.
------------------------------------------------------------------------
870.5550 Unscheduled DNA Ethalfluralin did
synthesis in not induce
mammalian cells unscheduled DNA
in culture synthesis in rat
hepatocytes.
------------------------------------------------------------------------
870.5375 In vitro mammalian In Chinese hamster
chromosome ovary cells,
aberration test ethalfluralin was
negative without
S9 activation,
but it was
clastogenic with
activation.
------------------------------------------------------------------------

[[Page 2336]]

870.7485 Metabolism and Rats were treated
pharmacokinetics orally with a
single low dose,
a single high
dose, or repeated
low doses of
radiolabeled
ethalfuralin.
Absorption of
ethalfluralin was
estimated at 79-
87% of the dose
for all dose
levels.
Ethalfluralin was
rapidly and
extensively
metabolized, and
95% of the
chemical was
excreted in urine
and feces by
seven days. The
major route of
elimination for
the radiolabel
was in the feces,
50.9-63.2%, and
the levels
remaining in the
tissues after 72
hours were
negligible.
------------------------------------------------------------------------
870.7600 Dermal penetration A Dermal
penetration study
with rhesus
monkeys indicated
that 2.8% of a
dermal dose was
absorbed through
the skin.
------------------------------------------------------------------------

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intra species differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor 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 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 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
(MOE_cancer= point of departure/exposures) is
calculated. A summary of the toxicological endpoints for ethalfluralin
used for human risk assessment is shown in the following Table 2:

Table 2.--Summary of Toxicological Dose and Endpoints for Ethalfluralin for Use in Human Risk Assessment

----------------------------------------------------------------------------------------------------------------
FQPA SF* and Level of
Exposure Scenario Dose Used in Risk Concern for Risk Study and Toxicological
Assessment, UF Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of NOAEL = 75 mg/kg/day FQPA SF = 10 Oral developmental
age UF = 100............... aPAD = acute RfD....... toxicity study in
Acute RfD = 0.75 mg/kg/ FQPA SF = 0.075 mg/kg/ rabbits
day. day. LOAEL = 150 mg/kg/day
based on an increased
number of resorptions
and increased sternal
and cranial variations.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population None None None
including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations NOAEL= 4.0 mg/kg/day FQPA SF = 10 1-year oral toxicity
UF = 100............... cPAD = chronic RfD..... study in dogs
Chronic RfD = 0.04 mg/ FQPA SF = 0.004 mg/kg/ LOAEL = 20 mg/kg/day
kg/day. day. based on altered red
cell morphology and
urinary bilirubin.
----------------------------------------------------------------------------------------------------------------

[[Page 2337]]

Short-term dermal (1 to 7 days) None None A dermal penetration
Intermediate-term dermal (1 week to study with rhesus
several months). monkeys indicated that
2.8% of a dermal dose
was absorbed through
the skin. Although the
developmental and
fetotoxic effects
(refer to
toxicological effects
for acute dietary for
females above) would
normally be used for
this assessment, the
dermal absorption rate
of 2.8% precludes the
need. Dermal
absorption is too low
to cause concern.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation (1 to 7 days) None None Ethalfluralin has a low
Intermediate-term Inhalation (1 week inhalation toxicity
to several months). category (III). The
Long-term inhalation (several months maximum attainable
to lifetime). concentration
(Residential)........................ (gravimetric) was
tested in an acute
inhalation toxicity
study, and no deaths
occurred to exposed
rats. Clinical signs
included hypoactivity,
dyspnea, ataxia,
chromodacryorrhea,
poor grooming, and
yellow urine; these
were reversible after
4 days (LC ₅₀ 0.94 mg/
L). This maximum
attainable
concentration is
considered to be non-
lethal. An inhalation
risk assessment is not
needed.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Ethalfluralin has been Negligible risk 2-year chronic
classified as a carcinogenicity study
possible human in rats, showing an
carcinogen (Group C). increased incidence of
Q₁* = 8.9 x 10-2 (mg/kg/ mammary gland
day)-1. fibroadenomas and
combined adenomas/
fibroadenomas in
female rats.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA. The safety factor of 10X was retained until ethalfluralin is assessed by the Agency's FQPA Safety
Factor Committee. Therefore, the 10X is subject to change when ethalfluralin is assessed in an upcoming
Tolerance Reassessment Eligibility Decision (TRED).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.416) for the residues of ethalfluralin, in or
on a variety of raw agricultural commodities. Tolerances for residues
of ethalfluralin are established for dry beans and peas, the Cucurbits
vegetable subgroup, peanuts, soybeans, sunflower seeds, and fat, meat,
and meat by-products of goats. The tolerance level for all these
commodities is 0.05 ppm. Time limited tolerances associated with
section 18 requests have also been established for canola and
safflower. Risk assessments were conducted by EPA to assess dietary
exposures from ethalfluralin 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. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 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 acute exposure assessments: Tolerance-level residues were used
for cucurbit vegetables, canola oil, safflower oil, and goat
commodities. All other plant commodities for which there are
ethalfluralin tolerances are considered to be blended. For these
commodities anticipated residues were used. The ARs used for this
analysis are the same as those used for the 1995 reregistration
eligibility decision (RED, 3/95) document prepared for ethalfluralin.
No percent crop-treated adjustment was made therefore, 100% crop
treated was assumed. Further refinements (such as percent crop-treated
adjustments and/or Monte Carlo analysis) would yield even lower
estimates of acute dietary exposure.
ii. Chronic exposure.In conducting this chronic dietary risk
assessment the DEEMTM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
Tolerance-level residues were used for cucurbit vegetables, canola oil,
safflower oil, and goat commodities. All other plant commodities for
which there are ethalfluralin tolerances are considered to be blended.
For these commodities anticipated residues were used. The ARs used for
this analysis are the same as those used for the 1995 reregistration
eligibility decision (RED, 3/95) document. In addition, weighted
average percent crop treated data were used for dry beans and peas,
melons, cantaloupe, cucumbers, watermelons and soybeans.
iii. Cancer. In conducting this cancer dietary risk assessment the
DEEMTM analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide CSFII. The
following assumptions were made for the cancer exposure assessments:
Tolerance-level residues were used for cucurbit vegetables, canola oil,
safflower oil, and goat commodities. All other plant commodities for
which there are

[[Page 2338]]

ethalfluralin tolerances are considered to be blended. For these
commodities anticipated residues were used. The ARs used for this
analysis are the same as those used for the 1995 reregistration
eligibility decision (RED, 3/95) document. In addition, weighted
average percent crop treated data were used for dry beans and peas,
melons, cantaloupe, cucumbers, watermelons and soybeans.
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop-
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used PCT information as follows: 34% of dry beans and
dry peas treated; 4% melons and cantaloups treated; 16% cucumbers
treated; 15% watermelons treated and 1% soybeans treated.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. The Agency is reasonably certain that the percentage of the
food treated is not likely to be an underestimation. As to Conditions 2
and 3, regional consumption information and consumption information for
significant subpopulations is taken into account through EPA's
computer-based model for evaluating the exposure of significant
subpopulations including several regional groups. Use of this
consumption information in EPA's risk assessment process ensures that
EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which ethalfluralin
may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for ethalfluralin 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 ethalfluralin.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
Screening Concentrations in Ground Water (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 incorporate an index reservoir environment in place of
the previous pond scenario. The PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a 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 %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 ethalfluralin they are
further discussed in the aggregate risk sections below.
Based on the PRZM/EXAMS and SCI-GROW models the EECs of
ethalfluralin for acute exposures are estimated to be 2.3 parts per
billion (ppb) for surface water and 0.02 ppb for ground water. The EECs
for chronic exposures are estimated to be 0.05 ppb for surface water
and 0.02 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). Ethalfluralin is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative

[[Page 2339]]

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 ethalfluralin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
ethalfluralin 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 ethalfluralin 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 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. Developmental toxicity studies. In the developmental toxicity
study in rats, the maternal (systemic) NOAEL was 50 milligram/kilogram/
day (mg/kg/day), based on decreased body weight gain and dark urine at
the LOAEL of 250 mg/kg/day. The developmental (fetal) NOAEL was 1,000
mg/kg/day (the highest dose tested, HDT).
In the developmental toxicity study in rabbits, the maternal
(systemic) NOAEL was 75 mg/kg/day, based on abortions and decreased
food consumption at the LOAEL of 150 mg/kg/day. The developmental
(fetal) NOAEL was also 75 mg/kg/day, based on a slightly increased
number of resorptions, abnormal cranial development, and increased
sternal variants at the LOAEL of 150 mg/kg/day.
3. Reproductive toxicity study. In a 3-generation reproductive
toxicity study in rats, the parental (systemic) NOAEL was 12.5 mg/kg/
day, based on decreased mean body weight gains in males in all
generations at the LOAEL of 37.5 mg/kg/day. The reproductive (pup)
NOAEL was 37.5 mg/kg/day (the HDT).
In a 7-month multi-generation bridging study in rats, the parental
NOAEL of 20 mg/kg/day was based on increased liver weights at the LOAEL
of 61 mg/kg/day. The reproductive (pup) NOAEL was 61 mg/kg/day (the
HDT).
4. Prenatal and postnatal sensitivity. There is qualitative
evidence of increased susceptibility following in utero exposure to
ethalfluralin in the developmental toxicity study in rabbits
demonstrated by abortions and a slightly increased number of
resorptions, abnormal cranial development, and increased sternal
variants in the pups. There was no indication of increased
susceptibility following in utero exposure to ethalfluralin in the
prenatal developmental toxicity study in rats.
5. Conclusion. There is a complete toxicity data base for
ethalfluralin and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures.
To date, ethalfluralin has not been assessed by the Agency's FQPA
Safety Factor Committee. The Agency is in the preliminary stages of
evaluating ethalfluralin for an upcoming Tolerance Reassessment
Eligibility Decision (TRED) (Reports on FQPA Tolerance Reassessment
Progress and Interim Risk Management Decisions). During this
reassessment, the Agency's FQPA Safety Factor Committee will evaluate
this chemical.
EPA's preliminary review of the studies bearing on risks to infants
and children indicates that an additional safety factor of greater than
10X will not be needed to protect the safety of infants and children.
Previously, when time-limited tolerances were established for residues
of ethalfluralin in or on canola seed and safflower seed to support
specific emergency exemptions the Agency concluded that an additional
FQPA safety factor of 3X for assessing acute dietary risk and an
additional FQPA safety factor of 1X for assessing chronic dietary risk
would be adequate for protecting the safety of infants and children.
This was based on a determination made by ad hoc FQPA Safety Factor
Committee which based its decision on the results of the oral
developmental toxicity study in rabbits.
Accordingly, for the purpose of acting on the petition for
tolerances for residues of ethalfluralin in or on canola seed and
safflower seed prior to completion of the ethalfluralin TRED, the FQPA
safety factor of 10X was retained.

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 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 + chronic non-dietary, non-occupational 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 USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to ethalfluralin in drinking water (when considered along
with other sources of exposure for which OPP has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because OPP considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, OPP will reassess the potential impacts
of ethalfluralin on drinking water as a part of the aggregate risk
assessment process.
1. Acute risk. An acute dietary endpoint was only identified for
females. Using the exposure assumptions discussed in this unit for

[[Page 2340]]

acute exposure, the acute dietary exposure from food to ethalfluralin
will occupy less than 1% of the aPAD for females 13 years and older. In
addition, despite the potential for acute dietary exposure to
ethalfluralin in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
ethalfluralin in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the aPAD, as shown in the
following Table 3:

Table 3.--Aggregate Risk Assessment for Acute Exposure to Ethalfluralin

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
ethalfluralin from food will utilize less than 1% of the cPAD for the
U.S. population and all other population subgroups included in
DEEMTM. There are no residential uses for ethalfluralin that
result in chronic residential exposure to ethalfluralin. In addition,
despite the potential for chronic dietary exposure to ethalfluralin in
drinking water, after calculating DWLOCs and comparing them to
conservative model estimated environmental concentrations of
ethalfluralin in surface and ground water, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD, as shown in the
following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Ethalfluralin

--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup cPAD mg/kg/day % cPAD (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 0.004 <1 0.05 0.02 140
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50 0.004 <1 0.05 0.02 120
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 0.004 <1 0.05 0.02 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants 0.004 <1 3.05 0.02 40
--------------------------------------------------------------------------------------------------------------------------------------------------------

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). Ethalfluralin 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 were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Ethalfluralin 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 were previously addressed.
5. Aggregate cancer risk for U.S. population. Using the exposure
assumptions described in this unit for cancer exposure, EPA has
concluded that exposure to ethalfluralin from food will result in an
estimated lifetime cancer risk to the U.S. population of 5.8 x
10-7. Currently there are no uses registered for
ethalfluralin that will result in residential exposures. In addition,
despite the potential for chronic (cancer) dietary exposure to
ethalfluralin in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
ethalfluralin in surface and ground water, EPA does not expect the
aggregate exposure to pose greater than a negligible risk (the range of
10-6), as shown in the following Table 5:

Table 5.--Aggregate Risk Assessment for Chronic (Cancer) Exposure to Ethalfluralin

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 ethalfluralin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (GLC-ECD) is available in PAM II
to enforce the tolerance expression. The

[[Page 2341]]

limit of detection in plant commodities is 0.01 ppm.

B. International Residue Limits

There are no Codex maximum residue limits (MRLs) established for
ethalfluralin. Mexico has established MRLs of 0.05 ppm in/on squash,
cucumber, and melon. Canada has labels for uses on oilseed and pulse
crops, wheat, field crop vegetables, barley, rapeseed, flax, canola,
and mustard however, there are no published tolerances.

V. Conclusion

Therefore, tolerances are established for residues of
ethalfluralin,[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl)benzenamine], in or on canola seed and safflower seed
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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-301208 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 March 18,
2002.
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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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) 260-4865.
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.
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.
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.2. Mail your
copies, identified by docket control number OPP-301208, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. 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. Regulatory Assessment Requirements

This final rule establishes a tolerance under FFDCA section 408(d)
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

[[Page 2342]]

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 FFDCA section 408(d), 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 FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

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: January 3, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.416 is amended as follows:
i. By alphabetically adding entries for the commodities ``canola,
seed'' and ``safflower, seed'' to the table in paragraph (a) as set
forth below.
ii. The text of paragraph (b) is removed and reserved.

Sec. 180.416 Ethalfluralin; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Canola, seed........................ 0.05
* * * * *
Safflower, seed..................... 0.05
* * * * *
------------------------------------------------------------------------

[[Page 2343]]

(b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. 02-701 Filed 1-16-02; 8:45 am]
BILLING CODE 6560-50-S