[Federal Register Volume 66, Number 67 (Friday, April 6, 2001)]
[Rules and Regulations]
[Pages 18201-18207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8484]



[[Page 18201]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301111; FRL-6773-7]
RIN 2070-AB78


Ethametsulfuron Methyl; Pesticide Tolerance

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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

SUMMARY: This regulation establishes a tolerance for residues of 
ethametsulfuron methyl (methyl 2- ((((4-ethoxy-6- (methylamino)-1,3,5- 
triazin-2-yl) amino) carbonyl) amino) sulfonyl) benzoate) in or on 
canola, crambe, and rapeseed. E.I. DuPont de Nemours and Company 
requested this tolerance under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES:  This regulation is effective April 6, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301111, 
must be received by EPA on or before June 5, 2001.

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-301111 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5697; 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:

------------------------------------------------------------------------
                                                          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/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm. 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-301111. 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 December 17, 1997 (62 FR 66083) (FRL-
5759-1), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of a pesticide petition (PP 1F4032) for tolerance 
by E.I. du Pont de Nemours and Company, Barley Mill Plaza, Walker's 
Mill Bldg. 37, Wilmington, DE 19880-0038. This notice included a 
summary of the petition prepared by E.I. du Pont de Nemours and 
Company, the registrant. There were no comments received in response to 
the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing a tolerance for residues of the herbicide ethametsulfuron 
methyl (methyl 2- ((((4-ethoxy-6- (methylamino)-1,3,5- triazin-2-yl) 
amino) carbonyl) amino) sulfonyl) benzoate) in or on canola seed at 0.1 
part per million (ppm). During the course of the review, EPA determined 
that the available residue data supported tolerances of 0.02 ppm in or 
on the raw agricultural commodities canola, crambe, and rapeseed at 
0.02 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

[[Page 18202]]

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).

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 a tolerance for residues of ethametsulfuron methyl on 
canola, crambe, and rapeseed at 0.02 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by ethametsulfuron 
methyl 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 = 365/453 mg/
                                  toxicity rodents -  kg/day (m/f)
                                   rats               highest dose
                                                      tested (HDT) LOAEL
                                                      = not determined,
                                                      supplementary due
                                                      to lack of toxic
                                                      response
                                                      (inadequate dose
                                                      levels)
 
                                 mice                NOAEL = >686/916 mg/
                                                      kg/day (m/f) HDT
                                                      LOAEL = not
                                                      determined
------------------------------------------------------------------------
870.3150                         90-Day oral         NOAEL = >390/383 mg/
                                  toxicity in         kg/day (m/f) LOAEL
                                  nonrodents - dogs   = not determined;
                                                      lack of a toxic
                                                      response
                                                      (inadequate dose
                                                      levels)
------------------------------------------------------------------------
870.3700a                        Prenatal            Maternal NOAEL =
                                  developmental in    1,000 mg/kg/day
                                  rodents - rats      LOAEL = 4,000 mg/
                                                      kg/day based on
                                                      decreased body
                                                      weight and
                                                      decreased food
                                                      consumption.
                                                      Developmental
                                                      NOAEL = 1,000 mg/
                                                      kg/day LOAEL =
                                                      4,000 mg/kg/day
                                                      based on reduced
                                                      fetal body weight
                                                      gain, increased
                                                      skeletal
                                                      variations
------------------------------------------------------------------------
870.3700b                        Prenatal            Maternal NOAEL =
                                  developmental in    250 mg/kg/day
                                  nonrodents -        LOAEL = 1,000 mg/
                                  rabbits             kg/day based on
                                                      increased relative
                                                      liver weight.
                                                      Developmental
                                                      NOAEL = 1,000 mg/
                                                      kg/day LOAEL =
                                                      4,000 mg/kg/day
                                                      based on increased
                                                      resorptions (early
                                                      fetal death),
                                                      decreased litter
                                                      size
------------------------------------------------------------------------
870.3800                         Reproduction and    Parental/systemic
                                  fertility effects   NOAEL = 395/449 (m/
                                                      f) mg/kg/day LOAEL
                                                      = 1,582/1,817 (m/
                                                      f) mg/kg/day based
                                                      on reduced body
                                                      weight and body
                                                      weight gain in
                                                      parent and Fla
                                                      males and females
 
                                                     Reproductive NOAEL
                                                      = 1582/817 (m/f)
                                                      mg/kg/day LOAEL =
                                                      not determined
------------------------------------------------------------------------
870.4100a                        Chronic toxicity    NOAEL = 210/267 mg/
                                  rodents             kg/day LOAEL = not
                                                      determined
------------------------------------------------------------------------
870.4100b                        Chronic toxicity    NOAEL = 87.3/386.9
                                  dogs                (m/f) mg/kg/day
                                                      LOAEL = 478/483 (m/
                                                      f) mg/kg/day based
                                                      on reduced body
                                                      weight gain, and
                                                      food efficiency,
                                                      decrease in mean
                                                      serum values
------------------------------------------------------------------------
870.4200                         Carcinogenicity     NOAEL = 210/267 mg/
                                  rats                kg/day LOAEL = not
                                                      determined. (no)
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.4300                         Carcinogenicity     NOAEL = 705/930 mg/
                                  mice                kg/day LOAEL = not
                                                      determined. (no)
                                                      evidence of
                                                      carcinogenicity
------------------------------------------------------------------------
870.5300                         Gene mutation       In vitro gene
                                                      mutation in CHO
                                                      cells. Negative
                                                      for mutagenicity
------------------------------------------------------------------------
870.5395                         Gene mutation       In vivo
                                                      micronucleus assay
                                                      in mice did not
                                                      induce bone marrow
                                                      toxicity
------------------------------------------------------------------------
870.5300                         Gene mutation       In vivo rat bone
                                                      marrow assay did
                                                      not induce bone
                                                      marrow did not
                                                      induce a
                                                      clastogenic
                                                      response
------------------------------------------------------------------------
870.5550                         Gene mutation       In vitro UDS assay
                                                      did not induce a
                                                      genotoxic effect
------------------------------------------------------------------------
870.5100                         Gene mutation       S. typhimurium/
                                                      mammalian
                                                      microsome assay
                                                      did not induce a
                                                      genotoxic effect
------------------------------------------------------------------------

[[Page 18203]]

 
870.7485                         Metabolism and      Submitted study
                                  pharmacokinetics    unacceptable by
                                                      current
                                                      guidelines. New
                                                      study required as
                                                      a condition of
                                                      registration
------------------------------------------------------------------------
870.7600                         Dermal penetration  No studies
                                                      available. Not
                                                      required since a
                                                      dermal risk
                                                      assessment is not
                                                      required
------------------------------------------------------------------------

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 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 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 ethametsulfuron methyl used for human risk assessment is 
shown in the following Table 2:

     Table 2.--Summary of Toxicological Dose and Endpoints for Ethametsulfuron methyl for Use in Human Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk      FQPA SF* and Endpoint   Study and Toxicological
          Exposure Scenario                 Assessment, UF        for Risk Assessment            Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                             A dose and endpoint were not selected because there were no effects
                                         observed in oral toxicology studies including maternal toxicity in the
                                        developmental toxicity studies in rats and rabbits that are attributable
                                                              to a single exposure (dose).
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 449 mg/kg/day    FQPA SF = 1x cPAD = 4.5  2-Generation
                                        UF = 100x                mg/kg/day                reproduction study in
                                                                                          rats.
----------------------------------------------------------------------------------------------------------------
                                       Chronic RfD = 4.5 mg/kg/                          LOAEL = 1817 mg/kg/day
                                        day                                               based on decreased
                                                                                          body wt. and body wt.
                                                                                          gain in parental
                                                                                          animals and F1a and
                                                                                          F1b generations.
----------------------------------------------------------------------------------------------------------------
Short-, intermediate and long-term       No endpoints were selected for exposure scenarios by the dermal route,
 dermal                                    since the dermal toxicity study in rats was waived based on lack of
                                        systemic toxicity in oral toxicity studies, thereby making the potential
                                                                  for risk negligible.
----------------------------------------------------------------------------------------------------------------
 Inhalation (any time period)             No endpoint was selected, based on the low toxicity, use pattern and
                                         method of application, there is no concern for potential exposure/risk
                                                                     via this route.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)         The carcinogenic potential of ethametsulfuron could not be evaluated
                                         since the highest dose tested in mice and rats did not elicit systemic
                                           toxicity. However, EPA noted that ethametsulfuron, is structurally-
                                         related to other sulfonylurea herbicides and does not show evidence of
                                             carcinogenicity or mutagenicity. Therefore, a quantitative risk
                                                              assessment is not warranted.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 18204]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. A time-limited 
tolerance has been established for the residues of (methyl 2- ((((4-
ethoxy-6- (methylamino)-1,3,5- triazin-2-yl) amino) carbonyl) amino) 
sulfonyl) benzoate), in or on canola in connection with FIFRA section 
18 emergency programs authorized in the 2000 growing season. Risk 
assessments were conducted by EPA to assess dietary exposures from 
ethametsulfuron methyl 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. A Dietary Exposure Evaluation Model (DEEM) acute 
exposure analysis was not performed since an appropriate endpoint 
attributable to a single exposure was not selected.
    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 Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: For chronic risk assessments, 
residue estimates for foods or food-forms of interest are multiplied by 
the average consumption estimate of each food/food-form of each 
population subgroup. Chronic exposure estimates are expressed in 
milligram/kilogram body weight/day (mg/kg bw/day) and as a percent of 
the cPAD. A DEEM chronic exposure analysis was performed using the 
proposed tolerance level residues (0.02 ppm) and 100% crop treated to 
estimate the exposure for the general population and subgroups of 
interest. The percent cPAD that would be above EPA's level of concern 
would be 100%. Percent crop treated (PCT) and/or anticipated residues 
were not used. Based on the results of this analysis, exposure to 
ethametsulfuron methyl from food will utilize <1% of the cPAD for all 
population groups.
    iii. Cancer. A DEEM cancer risk assessment is not performed because 
ethametsulfuron methyl is not expected to pose a cancer concern.
    2. Dietary exposure from drinking water. The Agency will use 
monitoring data to assess exposures for a comprehensive dietary 
exposure and risk assessment when available. Because ethametsulfuron 
methyl is not registered for use, drinking water monitoring data for 
use in the dietary exposure and risk assessment are not available. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on modeling 
taking into account data on the physical characteristics of 
ethametsulfuron methyl.
    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 Concentration 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 ethametsulfuron methyl, they are 
further discussed in the aggregate risk sections below.
    Based on the PRZM/EXAMS and SCI-GROW models, the EECs of 
ethametsulfuron methyl for acute exposures are estimated to be 0.48 
parts per billion (ppb) for surface water and 0.11 ppb for ground 
water. The EECs for chronic exposures are estimated to be 0.32 ppb for 
surface water and 0.11 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).
    Ethametsulfuron methyl 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 ethametsulfuron methyl 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, 
ethametsulfuron methyl 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 ethametsulfuron 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. Safety factor for infants and children--i. 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

[[Page 18205]]

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.
    ii. Prenatal and postnatal sensitivity. EPA determined that the 
available Agency Guideline studies indicated no increased 
susceptibility of rats or rabbits to in utero and/or postnatal exposure 
to ethametsulfuron. In the prenatal developmental toxicity studies in 
rats and rabbits as well as the 2-generation reproduction study in 
rats, toxicity to the fetuses/offspring, when observed, occurred at 
equivalent or higher doses than in the maternal/parental animals.
    iii. Conclusion. The toxicity data base for ethametsulfuron methyl 
is complete except for a general metabolism study. The current 
metabolism study is not acceptable by current guidelines. A guideline 
study is required as a condition of the registration. The exposure data 
are complete or estimated based on data that reasonably accounts for 
potential exposures. The FQPA Safety Factor Committee recommended that 
the 10x factor for protection of infants and children (as required by 
FQPA) be removed since: (1) The toxicology data base is complete except 
for the rat metabolism study. Requirements for developmental toxicity 
studies and reprodction studies are satisfied; (2) there is no 
indication of increased susceptibility of rats or rabbit fetuses to in 
utero and/or postnatal exposure in the developmental and reproductive 
toxicity data; (3) unrefined dietary exposure estimates are protective 
since they will exaggerate dietary exposure estimates; (4) EFED will 
model ground and surface source drinking water exposure assessments, 
resulting in estimates that are conservative upper-bound 
concentrations; and (5) there are currently no registered residential 
uses for ethametsulfuron and therefore, non-dietary exposure to infants 
and children is not expected.

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 + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by 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, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. An acute RfD (aRfD) was not established because a 
dose and endpoint attributable to a single exposure were not identified 
from the available oral toxicity studies, including maternal toxicity 
in the developmental toxicity studies.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
ethametsulfuron methyl from food will utilize <1% of the cPAD for the 
U.S. population, <1% of the cPAD for all infants (<1 year old) and <1% 
of the cPAD for children (1-6 years old). There are no residential uses 
for ethametsulfuron methyl that result in chronic residential exposure 
to ethametsulfuron methyl. In addition, there is potential for chronic 
dietary exposure to ethametsulfuron methyl in drinking water. After 
calculating DWLOCs and comparing them to the EECs for 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 Ethametsulfuron methyl
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                 cPAD mg/kg/    % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                          4.5           <1         0.32         0.11      160,000
----------------------------------------------------------------------------------------------------------------
Females 13+                                              4.5           <1         0.32         0.11      140,000
----------------------------------------------------------------------------------------------------------------
Infants all (<1 year old)                                4.5           <1         0.32         0.11       45,000
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old)                                 4.5           <1         0.32         0.11       45,000
----------------------------------------------------------------------------------------------------------------

    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).
    Ethametsulfuron methyl is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water

[[Page 18206]]

(considered to be a background exposure level).
    Ethametsulfuron methyl is not registered for use on any sites that 
would result in residential exposure. Therefore, the aggregate risk is 
the sum of the risk from food and water, which do not exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. A cancer aggregate 
risk assessment was not performed because ethametsulfuron methyl is not 
expected to pose a cancer concern.
    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 ethametsulfuron methy residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is an analytical method available using high performance 
liquid chromatography (HPLC) with a photoconductivity detector that has 
been validated by the petitioner to gather residue data at the 0.02 ppm 
tolerance. EPA recommends this method be used by analysts having access 
to a working photoconductivity conductor. An improved analytical method 
is being validated by EPA`s Analytical Chemistry Branch. Prior to 
publication in PAM II, and upon request, the existing HPLC analytical 
method for canola commodities will be available from the Analytical 
Chemistry Branch (ACB), Biological Economic Analysis Division (BEAD) 
(7503C), Environmental Science Center, 701 Mapes Road, Fort George G. 
Meade, MD 20755-5350; contact Francis D. Griffith, Jr., telephone (403) 
305-2905, e-mail [email protected]. The analytical standards for 
this method are also available from EPA's National Pesticide Standard 
Repository at the same location.

B. International Residue Limits

    There are no Codex, Canadian, and Mexican maximum residue levels 
(MRLs). However, ethametsulfuron methyl is registered in Canada on 
canola/rape and mustard with a default value of 0.1 ppm, with no 
published MRL. The use pattern and residue data support a U.S. 
tolerances of 0.02 on canola, crambe, and rapeseed.

C. Conditions

    A general metabolism study performed by current guidelines 
(870.7485) is being required as a condition of the registration.

V. Conclusion

    Therefore, the tolerances are established for residues of 
ethametsulfuron methyl (methyl 2- ((((4-ethoxy-6- (methylamino)-1,3,5- 
triazin-2-yl) amino) carbonyl) amino) sulfonyl) benzoate), in or on 
canola, crambe, and rapeseed at 0.02 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-301111 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 June 5, 
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 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-301111, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: opp-

[[Page 18207]]

[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). 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 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: March 21, 2001.

Anne E. Lindsay,

Acting Director, 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 180.563 is amended by adding paragraph (a) to read as 
follows:


Sec. 180.563   Ethametsulfuron methyl; tolerances for residues.

    (a) General. A tolerance is established for residues of 
ethametsulfuron methyl (methyl 2- ((((4-ethoxy-6- (methylamino)-1,3,5- 
triazin-2-yl) amino) carbonyl) amino) sulfonyl) benzoate) in or on the 
following raw agricultural commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Canola seed                                                         0.02
Crambe                                                              0.02
Rapeseed                                                            0.02
------------------------------------------------------------------------

* * * * *

[FR Doc. 01-8484 Filed 4-5-01; 8:45 am]
BILLING CODE 6560-50-S