[Federal Register Volume 66, Number 153 (Wednesday, August 8, 2001)]
[Rules and Regulations]
[Pages 41446-41454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19755]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected 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 [email protected], 
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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

VIII. 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