[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Rules and Regulations]
[Pages 57966-57972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24784]


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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301048; FRL-6744-1]
RIN 2070-AB78


Ethametsulfuron-methyl; Pesticide Tolerances for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of ethametsulfuron-methyl in or on canola. This action is in 
response to EPA's granting of emergency exemption under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use 
of the pesticide on canola. This regulation establishes a maximum 
permissible level for residues of ethametsulfuron-methyl in this food 
commodity. The tolerance will expire and is revoked on December 31, 
2001.

DATES: This regulation is effective September 27, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301048, 
must be received by EPA on or before November 27, 2000.

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 VII. of the SUPPLEMENTARY 
INFORMATION section of the document. To ensure proper receipt by EPA, 
your objections and hearing requests must identify docket control 
number OPP-301048 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Rosenblatt, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9375; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 57967]]

I. General Information

A. Does this Action Apply to Me?

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

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301048. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing a tolerance for residues of the herbicide ethametsulfuron-
methyl, in or on canola at 0.02 part per million (ppm). This tolerance 
will expire and is revoked on December 31, 2001. EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Ethametsulfuron-methyl on Canola and 
FFDCA Tolerances

    EPA has authorized under FIFRA section 18 the use of 
ethametsulfuron-methyl on canola for control of smartweeds in North 
Dakota and Minnesota. Products containing endothall had been available 
for use against smartweeds in the past. However, this use of endothall 
is no longer being supported. Therefore, after considering the 
situation this year, EPA determined that emergency conditions existed 
for the growers and permitted the use.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of ethametsulfuron-methyl in 
or on canola. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6). Although this tolerance will 
expire and is revoked on December 31, 2001, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on canola after that date 
will not be unlawful, provided the pesticide is applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by this tolerance at the time of that application. 
EPA will take action to revoke this tolerance earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether 
ethametsulfuron-methyl meets EPA's registration requirements for use

[[Page 57968]]

on canola or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as a basis for registration of ethametsulfuron-methyl 
by a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance serve as the basis for any State other than North Dakota 
and Minnesota to use this pesticide on this crop under section 18 of 
FIFRA without following all provisions of EPA's regulations 
implementing section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for 
ethametsulfuron-methyl, contact the Agency's Registration Division at 
the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
ethametsulfuron-methyl and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for a time-limited 
tolerance for ethametsulfuron-methyl in or on canola at 0.02 ppm. EPA's 
assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

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

    Table 1. -- Summary of Toxicological Dose and Endpoints for Ethametsulfuron-methyl 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                          NOAEL = none acute RfD   FQPA SF = 1x aPAD = n/a  A dose and endpoint
                                        = n/a                                             were not selected
                                                                                          since toxicological
                                                                                          effects attributable
                                                                                          to a single dose
                                                                                          (exposure) were not
                                                                                          available from the
                                                                                          oral toxicological
                                                                                          studies, including
                                                                                          developmental toxicity
                                                                                          studies in rats and
                                                                                          rabbits.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL = 449 mg/kg/day    FQPA SF = 1 x cPAD =     Parental/systemic NOAEL
                                        UF = 100 chronic RfD =   4.5 (chronic NOAEL)/ 1   = 449 mg/kg/day based
                                        4.5 mg/kg/day            x (FQPA SF) = 4.5 mg/    on reduced body weight
                                                                 kg/day                   and body weight gain
                                                                                          in P and F1a males and
                                                                                          females at the LOAEL
                                                                                          of 1,817 mg/kg/day in
                                                                                          a 2-generation
                                                                                          reproduction study.
----------------------------------------------------------------------------------------------------------------
Short-term, Intermediate-term, and     Dermal (or oral) study   LOC for MOE = n/a        A dose and endpoint
 Long-term dermal                       NOAEL = n/a                                       were not identified
                                                                                          since the dermal
                                                                                          toxicity study in rats
                                                                                          was waived based on
                                                                                          lack of systemic
                                                                                          toxicity in oral
                                                                                          toxicity studies.
----------------------------------------------------------------------------------------------------------------
Inhalation (any time period)           Inhalation (or oral)     LOC for MOE = n/a        No inhalation endpoints
                                        study NOAEL = n/a                                 were selected.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
  to the FQPA.


[[Page 57969]]

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. This is the first food 
use tolerance that will be established for this herbicide. In support 
of this action, 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 one day 
or single exposure. For this action, no acute dietary risk assessment 
was conducted. The rationale for this is that a dose and endpoint were 
not selected since toxicological effects attributable to a single dose 
(exposure) were not available from the oral toxicology studies, 
including developmental toxicity studies in rats and rabbits.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the dietary exposure evaluation model (DEEM) analysis 
evaluated the individual food consumption as reported by respondents in 
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
commodity. The following assumptions were made for the chronic exposure 
assessments: A conservative Tier I analysis using tolerance level 
residues was performed. Besides the use connected with this action, 
there are no other food use or residential registrations for 
ethametsulfuron-methyl. Percent crop-treated refinements and 
anticipated residues were not used.
    iii. Cancer. EPA did not conduct a quantitative cancer risk 
assessment for this action. The basis for this decision is that no 
evidence of chronic toxicity or carcinogenicity was seen in mice and 
rats; although, the dose levels tested in these studies were determined 
to be inadequate. The cancer potential for other sulfonylurea 
herbicides is also germane to this decision. Other sulfonylurea 
herbicides do not show evidence of carcinogenicity or mutagenicity.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for ethametsulfuron-methyl 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 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 estimated EECs of 
ethametsulfuron-methyl in surface water and ground water, respectively, 
for chronic exposures are estimated to be 0.3 parts per billion (ppb) 
for surface water and 0.1 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-methyl has 
a common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

C. Safety Factor for Infants and Children

    1. 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 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. Developmental toxicity studies. EPA has determined that there 
is adequate information about prenatal developmental toxicity to 
conclude that ethametsulfuron-methyl does not pose a

[[Page 57970]]

risk of increased sensitivity due to in utero exposure.
    iii. Reproductive toxicity study. There are adequate data for EPA 
to conclude that there is no indication of increased susceptibility of 
reproductive toxicity.
    iv. Prenatal and postnatal sensitivity. EPA considers the 
toxicology data base to be complete and has concluded that there is no 
indication of prenatal and postnatal sensitivity in rats and rabbits.
    v. Conclusion. There is a complete toxicity data base for 
ethametsulfuron-methyl and exposure data are complete or are estimated 
based on data that reasonably accounts for potential exposures. Given 
that EPA considers that the toxicology data base for ethametsulfuron-
methyl is complete. There is no indication of increased susceptibility 
of rat or rabbit fetuses to in utero and or postnatal exposure in the 
developmental and reproductive toxicity data. Unrefined dietary 
exposure estimates are protective since they will exaggerate dietary 
exposure estimates; and there are currently no registered residential 
uses for ethametsulfuron-methyl, and therefore, non-dietary exposure to 
infants and children is not expected. These factors led EPA to conclude 
that the special 10X safety factor for infants and children should be 
removed to 1X.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water (e.g., allowable chronic water exposure (mg/kg/day)= 
cPAD - (average food + chronic non-dietary, non-occupational 
exposure)). This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the US EPA Office of Water are used to calculate 
DWLOCs: 2 liters (L)/70 kilograms (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 ethametsulfuron-methyl 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 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 
ethametsulfuron- methyl on drinking water as a part of the aggregate 
risk assessment process.
    1. Acute risk. An aggregate acute risk assessment was not conducted 
since a dose and endpoint were not selected because toxicological 
effects attributable to a single dose (exposure) were not available 
from the oral toxicology studies, including developmental toxicity 
studies in rats and rabbits.
    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 0.0% of the cPAD for the 
U.S. population and all other sub populations. There are no residential 
uses for ethametsulfuron-methyl that result in chronic residential 
exposure to ethametsulfuron-methyl. In addition, despite the potential 
for chronic dietary exposure to ethametsulfuron-methyl in drinking 
water, after calculating the DWLOCs and comparing them to conservative 
model estimated environmental concentrations of ethametsulfuron-methyl 
in surface and ground water, EPA does not expect the aggregate exposure 
to exceed 100% of the cPAD, as shown in the following Table 2.

         Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Ethametsulfuron-methyl
----------------------------------------------------------------------------------------------------------------
                                                                       Surface       Ground
     Population Subgroup            cPAD mg/kg/day         %cPAD      Water EEC    Water EEC     Chronic DWLOC
                                                           (Food)       (ppb)        (ppb)      (microgram s/L)
----------------------------------------------------------------------------------------------------------------
U.S. Population                          4.5 mg/kg/day          0.0     0.32 ppb     0.11 ppb            160,000
----------------------------------------------------------------------------------------------------------------
Females 13+                              4.5 mg/kg/day          0.0     0.32 ppb     0.11 ppb            140,000
----------------------------------------------------------------------------------------------------------------
Infant and Children                      4.5 mg/kg/day          0.0     0.32 ppb     0.11 ppb             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 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).
    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 were previously 
addressed.
    5. Aggregate cancer risk for U.S. population. No evidence of 
chronic toxicity or carcinogenicity was seen in mice and rats; however, 
the dose levels tested in these studies were determined to be 
inadequate. However, it is noted that other sulfonylurea herbicides do 
not show evidence of carcinogenicity or mutagenicity. Therefore a 
quantitative risk assessment is not warranted.
    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

[[Page 57971]]

from aggregate exposure to ethametsulfuron-methyl residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    The manufacturer of ethametsulfuron-methyl has submitted a proposed 
enforcement method to EPA (MRID # 42022113).

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue level's have been 
established for ethametsulfuron-methyl.

VI. Conclusion

    Therefore, the tolerance is established for ethametsulfuron-methyl, 
in or on canola at 0.02 ppm.

VII. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301048 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 November 
27, 2000.
    1.Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301048, 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 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

VIII. Regulatory Assessment Requirements

    This final rule establishes a time limited tolerance under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types 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 prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low- Income Populations (59 FR 7629, February 16, 
1994); or require OMB review or any

[[Page 57972]]

Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). This action does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note). Since tolerances and exemptions that are 
established on the basis of a FIFRA section 18 petition under FFDCA 
section 408, such as the tolerance in this final rule, do not require 
the issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, 
the Agency has determined that this action will not have a substantial 
direct effect on States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

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

List of Subjects in 40 CFR Part 180

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

    Dated: September 12, 2000.

Susan B. Hazen,
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), (346a) and 371.


    2. Section 180.563 is added to read as follows:


Sec. 180.563  Ethametsulfuron- methyl; tolerances for residues.

    (a)General. [Reserved]
    (b)Section 18 emergency exemptions. A time-limited tolerance is 
established for ethametsulfuron-methyl (Methyl 2-(((((4-ethoxy-6- 
(methylamino)-1,3,5- triazin-2-yl)amino)carbonyl) 
amino)sulfonyl)benzoate) in or on canola in connection with the use of 
the pesticide under section 18 exemptions granted by EPA. The time-
limited tolerance will expire on the date specified in the following 
table:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                      Parts per   Revocation
                                                   million       Date
------------------------------------------------------------------------
Canola                                                 0.02     12/31/01
------------------------------------------------------------------------

    (c)Tolerances with regional registrations. [Reserved]
    (d)Indirect of inadvertent residues. [Reserved]

[FR Doc. 00-24784 Filed 9-26-00; 8:45 am]
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