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Ethametsulfuron-Methyl - Pesticide Tolerances for Emergency Exemptions 9/00

[Federal Register: September 27, 2000 (Volume 65, Number 188)]
[Rules and Regulations]
[Page 57966-57972]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se00-11]

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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.

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

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:
rosenblatt.dan@epa.gov.

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,            Dermal (or oral) study   LOC for MOE = n/a      A dose and endpoint
Intermediate-term,                              NOAEL = n/a            were not identified
and Long-term dermal                                                   since the dermal
                                                                       toxicity study in rats
                                                                       was waived based on
                                                                       lack of systemic
                                                                       toxicity in oral
                                                                       toxicity studies.
-------------------------------------------------------------------------------------------------
Inhalation            Inhalation (or oral)     LOC for MOE = n/a       No inhalation endpoints
(any time period)                           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 tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 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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