Ethalfluralin. Aug 8, 2001, Emergency Exemptions for Tolerances in/on Safflower Seed at 0.05 ppm. Final Rule. Federal Register.

FLUORIDE ACTION NETWORK PESTICIDE PROJECT

Ethalfluralin. August 8, 2001. Emergency Exemptions for tolerances in/on safflower seed at 0.05 ppm. Final Rule. Federal Register.

http://www.epa.gov/fedrgstr/EPA-PEST/2001/August/Day-08/p19755.htm

[Federal Register: August 8, 2001 (Volume 66, Number 153)]
[Rules and Regulations]
[Page 41446-41454]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au01-7]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301155; FRL-6793-2]
RIN 2070-AB78

Ethalfluralin; Pesticide Tolerances for Emergency Exemptions

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

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SUMMARY: This regulation establishes a time-limited tolerance for
residues of ethalfluralin in or on safflower seed. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on safflower. This regulation establishes a
maximum permissible level for residues of ethalfluralin in this food
commodity. The tolerance will expire and is revoked on June 30, 2003.

DATES: This regulation is effective August 8, 2001. Objections and
requests for hearings, identified by docket control number OPP-301155,
must be received by EPA on or before October 9, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please

[[Page 41447]]

follow the detailed instructions for each method as provided in Unit
VII of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA,
your objections and hearing requests must identify docket control
number OPP-301155 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; and e-mail address:
madden.barbara@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
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.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301155. 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, 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

EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing a tolerance for residues of the herbicide
ethalfluralin, [N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-
4(trifluoromethyl)benzenamine], in or on safflower seed at 0.05 part
per million (ppm). This tolerance will expire and is revoked on June
30, 2003. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
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. . . .''
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Ethalfluralin on Safflower and FFDCA
Tolerances

The applicants state that there are no herbicides registered for
use on safflower that effectively control kochia and ALS-resistant
kochia. Kochia resistant to sulfonylurea herbicides, 2,4-D, and dicamba
are found throughout the state. Research data and grower experience
indicate that Treflan (trifluralin) only provides suppression of kochia
and can result in three times more kochia density than Sonalan
(ethalfluralin). Kochia (especially ALS resistant biotypes) has become
a very serious weed problem that farmers have had difficulty
controlling. The problem has become particularly noticeable since 1998.
No specific economic data has been generated to study safflower yield
impacts from kochia competition. However, research conducted in several
other crops has documented that yield

[[Page 41448]]

reductions of 25 to 75 percent can result from kochia competition.
Safflower is an annual oil seed crop that is most productive when
seeded early in the spring. Annual grasses and broadleaf weeds that
compete with safflower germinate and emerge along with safflower
seedlings. Although delayed seeding and or tillage can reduce weed
abundance, it is not a compatible practice in safflower production.
Safflower is not very competitive with weeds in the early vegetative
stages. In-crop cultivation is not viable for weed control. Harrowing
after planting with a light spike tooth or light coil spring may
control some weeds, but damage to the emerging safflower can occur and
some plants will be buried.
EPA has authorized under FIFRA section 18 the use of ethalfluralin
on safflower for control of kochia and ALS-resistant kochia in North
Dakota and Montana. After having reviewed the submission, EPA concurs
that emergency conditions exist for these States.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of ethalfluralin in or on
safflower. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although this tolerance will
expire and is revoked on June 30, 2003, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerance remaining in or on safflower seed after that date will not be
unlawful, provided the pesticide is applied in a manner that was lawful
under FIFRA, and the residues do not exceed a level that was authorized
by this tolerance at the time of that application. EPA will take action
to revoke this tolerance earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether ethalfluralin
meets EPA's registration requirements for use on safflower or whether a
permanent tolerance for this use would be appropriate. Under these
circumstances, EPA does not believe that this tolerance serves as a
basis for registration of ethalfluralin by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than North Dakota and Montana to use this
pesticide on this crop under section 18 of FIFRA without following all
provisions of EPA's regulations implementing section 18 as identified
in 40 CFR part 166. For additional information regarding the emergency
exemption for ethalfluralin, contact the Agency's Registration Division
at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

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 (62 FR 62961, November 26, 1997) (FRL-5754-7).
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
ethalfluralin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
residues of ethalfluralin in or on safflower seed at 0.05 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed adverse effect level (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
dose at which the lowest adverse effect level (the LOAEL) is sometimes
used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (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 level of concern (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 1:

[[Page 41449]]

Table 1. -- 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 UF FQPA SF = 3 aPAD = Oral developmental
age = 100 Acute RfD = 0.75 acute RfD toxicity study in
mg/kg/day FQPA SF = 0.25 mg/kg/ rabbits LOAEL = 150 mg/
day 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 = 1 cPAD = 1-year oral toxicity
UF = 100 Chronic RfD = chronic RfD study in dogs LOAEL =
0.04 mg/kg/day FQPA SF = 0.04 mg/kg/ 20 mg/kg/day based on
day altered red cell
morphology and urinary
bilirubin.
----------------------------------------------------------------------------------------------------------------
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) Long-term category (III). The
inhalation (several months to maximum attainable
lifetime) (Residential) concentration
(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 (LC₅₀ >0.94 mg/
L). This maximum
attainable
concentration is
considered to be non-
lethal. An inhalation
risk assessment is not
required
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Ethalfluralin has been 10-6 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/ mammary gland
kg/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.

B. 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. Permanent tolerances for
residues of ethalfluralin are established for dry beans and peas,
cucurbits, peanuts, soybeans, sunflower seeds, and goats (fat, meat,
and meat byproducts). These tolerances are all 0.05 ppm. A 0.05 ppm
time-limited tolerance associated with a section 18 request is also
established for canola. 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

[[Page 41450]]

indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. The dietary exposure evaluation model
(DEEM) 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 (ARs) were used. The ARs used for this analysis
are the same as those used for the March 1995 reregistration
eligibility decision (RED) document prepared for ethalfluralin. No
percent crop treated (PCT) 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 DEEM 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 ARs were used. The ARs used for this analysis are the same
as those used for the March 1995, RED document. In addition, weighted
average PCT data were used for dry beans and peas, melons, cantaloupe,
cucumbers, watermelons and soybeans.
iii. Cancer. In conducting this cancer dietary risk assessment the
DEEM 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 ethalfluralin tolerances are considered to be blended. For these
commodities ARs were used. The ARs used for this analysis are the same
as those used for the March 1995, RED document. In addition, weighted
average PCT data were used for dry beans and peas, melons, cantaloupe,
cucumbers, watermelons and soybeans.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
authorizes EPA to use available data and information on the ARs 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
ARs 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.
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 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
peas treated; 4% melons and cantaloupes treated; 16% cucumbers treated;
15% watermelons treated and 1% soybeans treated.
The Agency believes that the three conditions listed 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 under
estimate 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. For acute dietary
exposure estimates, EPA uses an estimated maximum PCT. The exposure
estimates resulting from this approach reasonably represent the highest
levels to which an individual could be exposed, and are unlikely to
under estimate an individual's acute dietary exposure. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be an under estimation. 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
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

[[Page 41451]]

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 estimated
environmental concentrations (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 0.052 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 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).

C. 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 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 milligrams/
kilograms/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 estimated based on data
that reasonably accounts for potential exposures. Based on the oral
developmental toxicity study in rabbits, an ad hoc FQPA Safety Factor
Committee determined that the appropriate safety factor for assessing
acute dietary risk is 3X and for assessing chronic dietary risk is 1X.

D. 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 US EPA Office of Water

[[Page 41452]]

to calculate DWLOCs: 2Liters/70 kilograms (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 in 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
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 2:

Table 2. -- Aggregate Risk Assessment for Acute Exposure to Ethalfluralin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface Water EEC Ground Water EEC
Population Subgroup aPAD (mg/kg) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.25 <1 2.3 0.02 7,500
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 DEEM.
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 EECs 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 3:

Table 3. -- 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 0.40 <1 0.052 0.02 1,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children 0.40 <1 0.052 0.02 400
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants 0.40 <1 0.052 0.02 400
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 EECs of ethalfluralin in surface and ground
water, EPA does not expect the aggregate exposure to be greater than 1
x 10-6, as shown in the following Table 4:

Table 4.-- Aggregate Risk Assessment for Chronic (Cancer) Exposure to Ethalfluralin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer Risk Surface Water EEC Ground Water EEC Chronic DWLOC
Population Subgroup Q₁* Estimate (Food) (ppb) (ppb) (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population 8.9 x 10-2 5.8 x 10-7 0.052 0.02 0.18
(mg/kg/day)-1
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 41453]]

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.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (GLC-ECD) is available in PAM II
to enforce the tolerance expression. The 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 oil seed and pulse
crops, wheat, field crop vegetables, barley, rapeseed, flax, canola,
and mustard. There are no published tolerances so presumably the
Canadian default tolerance of 0.10 ppm applies to these crops.

C. Conditions

Do not exceed 1.15 lbs. active ingredient (ethalfluralin) per acre
per crop year.

VI. Conclusion

Therefore, the tolerance is established for residues of
ethalfluralin, N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-
4(trifluoromethyl)benzenamine, in or on safflower seed at 0.05 ppm.

VII. 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-301155 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 October
9, 2001.
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 VII.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 the docket control number OPP-301155, 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).

VIII. Regulatory Assessment Requirements

This final rule establishes a time limited tolerance under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types

[[Page 41454]]

of actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). This final rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any other
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 FIFRA section 18 exemption under FFDCA
section 408, 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.

IX. 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: July 25, 2001.

James Jones,
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 by alphabetically adding commodities
to the table in paragraph (b) to read as follows:

Sec. 180.416 Ethalfluralin; tolerances for residues.

* * * * *
(b) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------

* * * * *
Safflower, seed 0.05 6/30/03
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-19755 Filed 8-7-01; 8:45 a.m.]
BILLING CODE 6560-50-S