[Federal Register Volume 67, Number 12 (Thursday, January 17, 2002)]
[Rules and Regulations]
[Pages 2333-2343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-701]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301208; FRL-6818-6]
RIN 2070-AB78


Ethalfluralin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
ethalfluralin in or on canola seed and safflower seed. IR-4 requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: This regulation is effective January 17, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301208, 
must be received by EPA on or before March 18, 2002.

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

[[Page 2334]]



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

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301208. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 14, 2001 (66 FR 57082) (FRL-
6808-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a as amended by the FQPA (Public Law 104-170) announcing the 
filing of pesticide petitions (PP 9E5037, 1E6326, and 1E6345) for 
tolerances by Interregional Research Project Number 4 (IR-4), 681 U.S. 
Highway Number 1, South, North Brunswick, New Jersey 08902-3390. This 
notice included a summary of the petitions prepared by Dow 
AgroSciences, the registrant. There were no comments received in 
response to the notice of filing.
    The petitions requested that 40 CFR 180.416 be amended by 
establishing tolerances for residues of the herbicide ethalfluralin, 
[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl)benzenamine, in or on canola seed and safflower seed 
at 0.05 part per million (ppm).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances, November 26, 1997) (62 FR 62961) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of ethalfluralin on canola seed 
and safflower seed at 0.05 ppm. EPA's assessment of exposures and risks 
associated with establishing the tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by ethalfluralin are 
discussed in the following Table 1 as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

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

[[Page 2335]]

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

[[Page 2336]]

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

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intra species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary 
method currently used by the Agency to quantify carcinogenic risk. The 
Q* approach assumes that any amount of exposure will lead to 
some degree of cancer risk. A Q*: is calculated and used to 
estimate risk which represents a probability of occurrence of 
additional cancer cases (e.g., risk is expressed as 1 x 10-6 
or one in a million). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. In this 
non-linear approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer= point of departure/exposures) is 
calculated. A summary of the toxicological endpoints for ethalfluralin 
used for human risk assessment is shown in the following Table 2:

    Table 2.--Summary of Toxicological Dose and Endpoints for Ethalfluralin for Use in Human Risk Assessment
 
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary females 13-50 years of   NOAEL = 75 mg/kg/day     FQPA SF = 10             Oral developmental
 age                                   UF = 100...............  aPAD = acute RfD.......   toxicity study in
                                       Acute RfD = 0.75 mg/kg/  FQPA SF = 0.075 mg/kg/    rabbits
                                        day.                     day.                    LOAEL = 150 mg/kg/day
                                                                                          based on an increased
                                                                                          number of resorptions
                                                                                          and increased sternal
                                                                                          and cranial
                                                                                          variations.
----------------------------------------------------------------------------------------------------------------
Acute dietary general population       None                     None                     None
 including infants and children
----------------------------------------------------------------------------------------------------------------
Chronic dietary all populations        NOAEL= 4.0 mg/kg/day     FQPA SF = 10             1-year oral toxicity
                                       UF = 100...............  cPAD = chronic RfD.....   study in dogs
                                       Chronic RfD = 0.04 mg/   FQPA SF = 0.004 mg/kg/   LOAEL = 20 mg/kg/day
                                        kg/day.                  day.                     based on altered red
                                                                                          cell morphology and
                                                                                          urinary bilirubin.
----------------------------------------------------------------------------------------------------------------

[[Page 2337]]

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

C. Exposure Assessment

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

[[Page 2338]]

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

[[Page 2339]]

effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether ethalfluralin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
ethalfluralin does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that ethalfluralin has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

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

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD - (average food + chronic non-dietary, non-occupational exposure). 
This allowable exposure through drinking water is used to calculate a 
DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to ethalfluralin in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of ethalfluralin on drinking water as a part of the aggregate risk 
assessment process.
    1. Acute risk. An acute dietary endpoint was only identified for 
females. Using the exposure assumptions discussed in this unit for

[[Page 2340]]

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

                                         Table 3.--Aggregate Risk Assessment for Acute Exposure to Ethalfluralin
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC
                   Population Subgroup                        aPAD (mg/kg)      % aPAD (Food)          (ppb)              (ppb)        Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females (13-50 years old)                                              0.075                 <1                2.3               0.02              2,200
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

                                 Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Ethalfluralin
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                 Surface Water EEC   Ground Water EEC    Chronic DWLOC
                   Population Subgroup                       cPAD mg/kg/day     % cPAD (Food)          (ppb)              (ppb)              (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. population                                                        0.004                 <1               0.05               0.02                140
--------------------------------------------------------------------------------------------------------------------------------------------------------
Females 13-50                                                          0.004                 <1               0.05               0.02                120
--------------------------------------------------------------------------------------------------------------------------------------------------------
Children                                                               0.004                 <1               0.05               0.02                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infants                                                                0.004                 <1               3.05               0.02                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

                                   Table 5.--Aggregate Risk Assessment for Chronic (Cancer) Exposure to Ethalfluralin
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 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 (mg/kg/        5.8 x 10-7               0.05               0.02               0.18
                                                                      day)-1
--------------------------------------------------------------------------------------------------------------------------------------------------------

    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to ethalfluralin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

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

[[Page 2341]]

limit of detection in plant commodities is 0.01 ppm.

B. International Residue Limits

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

V. Conclusion

    Therefore, tolerances are established for residues of 
ethalfluralin,[N-ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-
(trifluoromethyl)benzenamine], in or on canola seed and safflower seed 
at 0.05 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301208 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before March 18, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [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 VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301208, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public

[[Page 2342]]

Law 104-4). Nor does it require any special considerations under 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerance in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

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

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

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


Sec. 180.416  Ethalfluralin; tolerances for residues.

    (a) *  *  *  

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


[[Page 2343]]

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

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