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Bentazon - Pesticide Tolerance 1/02

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP-301215; FRL-6820-9]
RIN 2070-AB78
Bentazon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances with regional
registration for combined residues of bentazon in or on clover, forage
and clover, hay. The Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective February 7, 2002. Objections and
requests for hearings, identified by docket control number OPP-301215,
must be received by EPA on or before April 8, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301215 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-7610; and e-mail address:
jackson.sidney@epa.gov.

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 Potentially
             Categories                 NAICS       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_180/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-301215. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 2, 2001 (66 FR 55660) (FRL-
6806-1), 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) for tolerance by the
Interregional Research Project #4, 681 U.S. Highway #1 South, North
Brunswick, New Jersey 08902-3390. This notice included a summary of the
petition prepared by BASF Corporation, Agricultural Division, the
registrant. There were no comments received in response to the notice
of filing.
    The petition requested that 40 CFR 180.355 be amended by
establishing tolerances with regional registration for combined
residues of the herbicide bentazon, (3-isopropyl-1H-2,1,3-
benzothiadiazin-4(3H)-one 2,2-dioxide) and its 6- and 8-hydroxy
metabolites, in or on clover, forage at 1.0 ppm and clover, hay at 2.0
ppm. Registration will be limited to clover grown for seed in the
States of Oregon and Washington based on the available residue data.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is "safe." Section
408(b)(2)(A)(ii) defines "safe " to mean that " there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information." This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to "ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue.... "
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (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 tolerances for combined residues of bentazon on clover,
forage at 1.0 ppm and clover, hay at 2.0 ppm. EPA's assessment of
exposures and risks associated with establishing these tolerances
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by bentazon are
discussed in the Federal Register of March 8, 2000 (65 FR 121222) (FRL-
6492-7) as well as the no observed adverse effect level (NOAEL) and the
lowest observed adverse effect level (LOAEL) from the toxicity studies
reviewed.

B. Toxicological Endpoints

    The dose at which 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 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 = point of departure/exposures) is calculated. A
summary of the toxicological endpoints for bentazon used for human risk
assessment is shown in the following Table 1:

       Table 1.--Summary of Toxicological Dose and Endpoints for bentazon for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                FQPA SF\*\ and Level of
          Exposure Scenario               Dose Used in Risk Concern for Risk     Study and Toxicological
                                            Assessment, UF Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of   Developmental NOAEL =    FQPA SF = 10 aPAD =      Developmental Toxicity-
 age                                    100 mg/kg/day; UF = acute RfDFQPA    Rat LOAEL = 250 mg/kg/
                                        100; Acute RfD = 1.0     SF = 0.1 mg/kg/day       day based on increased
                                        mg/kg/day postimplantation loss,
skeletal variations,
and reduced weight of
fetuses.
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NONE                     NONE A dose and non-
 including infants and children developmental endpoint
attributable to a
single exposure were
not identified in oral
toxicity studies.
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations        NOAEL = 3.2 mg/kg/day;   FQPA SF = 10 cPAD =      One-Year Feeding Study
                                        UF = 100; Chronic RfD chronic                   Dog LOAEL = 13.1 mg/
                                        = 0.03 mg/kg/day RfDFQPA SF =     kg/day and based on a
0.003 mg/kg/day          dose-dependent
presence of feces with
red areas in dogs at
13.1 and 52.3 mg/kg/
day (HDT), and slight
to severe anemia at
the high dose.
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7              NONE                     NONE No systemic toxicity
 days)(Residential) was seen at the Limit-
Dose in a 21-day
dermal toxicity study
in rabbits.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to    Oral NOAEL = 13.1 mg/kg/  LOC for MOE = 1,000     One - Year Feeding
 several months)\1\ (Residential)       day (dermal absorption (Residential)            Study - Dog LOAEL =
                                        rate = 2% 52.3 mg/kg/day based
on the presence of
feces with red areas
seen in dogs at weeks
4, 6, and 12.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to    Oral NOAEL= 3.2 mg/kg/    LOC for MOE = 1,000     One-Year Feeding Study
 lifetime)\1,\\2\ (Residential)         day (dermal absorption (Residential)             Dog LOAEL = 13.1 mg/
                                        rate = 2% when kg/day based on a dose-
                                        appropriate) dependent presence of
feces with red areas
in dogs at the LOAEL
of 13.1 mg/kg/day
(seen at week 33) and
52.3 mg/kg/day (HDT),
and slight to severe
anemia at the high
dose.
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7          Oral developmental       LOC for MOE = 1,000      Developmental Toxicity
 days)\2\ (Residential)                 NOAEL= 100 mg/kg/day (Residential)             Rat LOAEL = 250 mg/kg/
day based on increased
postimplantation loss,
skeletal variations,
and reduced weight of
fetuses.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week   Oral NOAEL = 13.1 mg/kg/ LOC for MOE = 1,000      One-Year Feeding Study
 to several months)\3\ (Residential)    day (Residential)             Dog LOAEL = 52.3 mg/
kg/day based on the
presence of feces with
red areas seen in dogs
at weeks 4, 6, and 12.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months   Oral NOAEL= 3.2 mg/kg/   LOC for MOE = 1,000      One Year Feeding Study
 to lifetime)\3,\\4\ (Residential)      day (Residential)             Dog LOAEL = 13.1 mg/
kg/day based on a dose-
dependent presence of
feces with red areas
in dogs at a LOAEL of
13.1 mg/kg/day (seen
at week 33) and 52.3
mg/kg/day (HDT), and
slight to severe
anemia at the high
dose.
----------------------------------------------------------------------------------------------------------------
\1\ A dermal absorption factor of 2% should be used for route-to-route extrapolation.
\2\ An inhalation absorption factor of 100% should be used for route-to-route extrapolation for short-term
  inhalation risk assessment.
\3\ An inhalation absorption factor of 100% and a dermal absorption factor of 2% should be used for route-to-
  route extrapolation for intermediate- and long-term risk assessments.
\4\ Although long-term dermal and inhalation endpoints were selected, the current use pattern does not indicate
  a concern for long-term dermal or inhalation exposure potential. Long-term dermal and inhalation risk
  assessments were not conducted.
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.355(a)) for the combined residues of bentazon
(3-isopropyl-1H-2,1,3-benzothiadiazin-4 (3H)-one-2,2-dioxide) and its
6- and 8-hydroxy metabolites, in or on a variety of raw agricultural
commodities. Tolerances are also established for the combined residues
of the herbicide bentazon (3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-
one-2,2-dioxide) and its metabolite 2-amino-N-isopropyl benzamide
(AIBA) in or on the following food commodities: for cattle, goats,
hogs, poultry, and sheep, fat, meat-by-products, and meat, with a
tolerance of 0.05 ppm, for eggs, with a tolerance of 0.05 ppm, and
milk, with a tolerance of 0.02 ppm. Risk assessments were conducted by
EPA to assess dietary exposures from bentazon 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. The Dietary Exposure Evaluation Model
(DEEM) analysis evaluated the individual food consumption as
reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: An acute analysis was performed
using tolerance level residues, 100% crop treated (CT), and DEEM
default processing factors for all commodities.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
CSFII and accumulated exposure to the chemical for each commodity. The
following assumptions were made for the chronic exposure assessments:
EPA used survey data to estimate the percent crop treated for certain
commodities. For all other commodities 100% CT was assumed. An
anticipated residue was calculated for succulent peas using average
residue values (1.08 ppm) from the submitted crop field trials. DEEM
default processing factors were used for all commodities.
    iii. Cancer. Bentazon has been classified as a Group E chemical
(evidence of non-carcinogenicity for humans) based upon lack of
evidence of carcinogenicity in rats and mice. Therefore, no cancer risk
is expected.
    iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of
these tolerances.
    Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used percent crop treated (PCT) information as follows.
For the acute analysis, tolerance level residues and 100% CT was
assumed for all commodities. EPA used survey data of the percent CT in
the chronic dietary exposure analysis of some commodities. Surveys of
several commodities indicate that the percent of the crops treated are
as follows: mint (25%), sweet corn (13%), snap beans (15%), green peas
(13%), dry beans and peas (17%), alfalfa (0%), sorghum (0%), corn (1%),
rice (5%), peanuts (27%), soybeans (12%), and potatoes (0%). Although
the surveys indicated no use of bentazon on alfalfa, sorghum and
potatoes, EPA used a value of 1% CT in the chronic dietary exposure
analysis. For all crops other than mint, sweet corn, snap beans, green
peas, dry bean and peas, alfalfa, sorghum, corn, rice, peanuts,
soybeans and potatoes, 100% CT was used. Tolerance level residues were
used for all crops, except succulent peas. An Anticipated Residue was
calculated for succulent peas using average residue values (1.08 ppm)
from the submitted crop field trials.
    The Agency believes that the three conditions imposed by section
408(b)(2)(F) listed above have been met. With respect to Condition 1,
PCT estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. EPA uses a weighted average
PCT for chronic dietary exposure estimates. This weighted average PCT
figure is derived by averaging State-level data for a period of up to
10 years, and weighting for the more robust and recent data. A weighted
average of the PCT reasonably represents a person's dietary exposure
over a lifetime, and is unlikely to underestimate exposure to an
individual because of the fact that pesticide use patterns (both
regionally and nationally) tend to change continuously over time, such
that an individual is unlikely to be exposed to more than the average
PCT over a lifetime. For acute dietary exposure estimates, EPA uses an
estimated maximum PCT. The exposure estimates resulting from this
approach reasonably represent the highest levels to which an individual
could be exposed, and are unlikely to underestimate an individual's
acute dietary exposure. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which bentazon may
be applied in a particular area.
    2. Dietary exposure from drinking water. Degradation products of
bentazon in the tolerance expression are 8-hydroxy bentazon (plants),
6-hydroxy bentazon (plants), and AIBA (animals). AIBA was the only
degradation product in the tolerance expression which was found in
standard laboratory environmental fate studies. Therefore, the water
assessment was conducted for bentazon and AIBA. SCI-GROW (Screening
Concentration in Ground Water) modeling indicates that bentazon residue
concentrations in ground water used as drinking water are not likely to
exceed 4.25 parts per billion (ppb). Since monitoring data show
bentazon has been detected in ground water at higher concentrations
than the Sci-GROW Screening Model, EPA used 20 ppb as the
representative national Tier 1 ground water screening concentration for
bentazon.
    Tier II Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM-EXAMS) modeling indicates that cumulative bentazon residue
(bentazon + AIBA) concentrations in surface water to be used as
screening concentrations for bentazon are 41 ppb for the 1 in 10 year
peak (acute) and 8 ppb for the 36 year annual mean (chronic).
    A preliminary review of the National Water Quality Assessment
Program (NAWQA) monitoring data suggest that
bentazon concentrations in surface water are substantially lower than
model predictions. There are no surface water monitoring data for
bentazon degradation products. Bentazon has been detected in 37
agricultural streams at a concentration of 0.05 ppb for the 95th
percentile and estimated maximum concentration of 5 ppb and 14
integrator sites on large streams at a concentration of 0.15 ppb for
the 95th percentile and estimated maximum concentration of 2.8
μg/L. Bentazon was not detected (less than Method of Detection
Limit) in urban streams (http://water.wr.usgs.gov/pnsp/gwsw1.html, 3/
27/98). Bentazon is not reported in the latest summary of the NAWQA
monitoring data (Larson, et al., "Pesticides in Streams of the United
States-Initial Results from the National Water-Quality Assessment
Program Water Resources Investigations Report" 98-4222). Bentazon
degradation products were not part of the analysis in the NAWQA
monitoring program.
    The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the PRZM/EXAMS to estimate pesticide concentrations in
surface water and SCI-GROW, which predicts pesticide concentrations in
groundwater. In general, EPA will use GENEEC (a tier 1 model) before
using PRZM/EXAMS (a tier II 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 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 bentazon they are further discussed in the aggregate risk
sections below.
    Based on the PRZM/EXAMS and SCI-GROW models and monitoring data for
ground water the EECs of bentazon for acute exposures are estimated to
be 41 ppb for surface water and 20 ppb for ground water. The EECs for
chronic exposures are estimated to be 8 ppb for surface water and 20
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).
    Bentazon is currently registered for use on the following
residential non-dietary sites: turf and ornamentals. The risk
assessment was conducted using the following residential exposure
assumptions:
    Because bentazon is registered for consumer use on turf and
ornamentals, there is potential for residential exposure to adult
applicators and adults and children entering recreational and
residential areas treated with bentazon. The handler exposure is
expected to be short-term while the post-application exposure is
expected for both the short- and intermediate-term. However, since
there is no short-term dermal endpoint, the residential post-
application exposure cannot be aggregated with the handler exposure.
Short-term, non-dietary ingestion exposure for toddlers is not assessed
since there is no acute dietary or oral endpoint applicable to infants
and children (endpoint was applicable to women of child-bearing age).
However, intermediate-term, non-dietary ingestion exposure to toddlers
playing on treated turf is possible and was assessed. There are no
chemical-specific or site-specific data available to determine the
potential risks associated with residential exposures from handling
bentazon. Therefore, the exposure estimates are based on assumptions
and generic data as specified by the December 18, 1997 Draft Health
Effects Division(HED) of EPA Standard Operating Procedures(SOP) for
Residential Exposure Assessments. Since bentazon is applied no more
than twice per year, only short-term exposure is expected for the
residential handler. Since a dermal endpoint of concern was not
identified for the short-term duration, only inhalation exposure
estimates are relevant. Based on the residential use pattern, no long-
term post-application residential exposure is expected.
    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 bentazon 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,
bentazon 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 bentazon 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
database 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. Prenatal and postnatal sensitivity. Both the rat developmental
and reproductive toxicity studies indicate increased susceptibility
from in utero and postnatal exposure to bentazon. The available
developmental toxicity data in rabbits did not provide an indication of
increased susceptibility from in utero exposure to bentazon.
    iii. Conclusion. There is a complete toxicity database for bentazon
and exposure data are complete or are
estimated based on data that reasonably accounts for potential
exposures. The FQPA safety factor for protection of infants and
children will be retained at 10x in assessing the risk posed by
bentazon. This decision is based on:
    a. Evidence of increased susceptibility following in utero exposure
to bentazon in the prenatal developmental toxicity study in rats in the
absence of maternal toxicity.
    b. Quantitative evidence of increased susceptibility following
prenatal/postnatal exposure to bentazon in the 2-generation
reproduction study in rats.

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 groundwater 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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
bentazon will occupy 2.0% of the aPAD for females 13 years and older.
No appropriate end-point was available to quantitate risk to the
general U.S. population from a single dose administration of bentazon.
In addition, there is potential for acute dietary exposure to bentazon
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 aPAD, as shown in the following Table 2:

                       Table 2.--Aggregate Risk Assessment for Acute Exposure to bentazon
----------------------------------------------------------------------------------------------------------------
Surface       Ground
             Population Subgroup\1\               aPAD (mg/      % aPAD     Water EEC    Water EEC      Acute
                                                     kg) (Food)       (ppb)        (ppb)       DWLOC\2\
----------------------------------------------------------------------------------------------------------------
Female 13-50 yrs. old                                    0.1 2           41           20        2,900
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroup chosen was the female subgroup with the highest food exposure (60 kg. body weight
  assumed).
\2\ Allowable Drinking Water Exposure (mg/kg/day) = aPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day).

    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to bentazon
from food will utilize 10% of the cPAD for the U.S. population, 12% of
the cPAD for non-nursing infants and 28% of the cPAD for children 1-6
years old, most highly exposed subpopulation. Based on the use pattern,
chronic residential exposure to residues of bentazon is not expected.
In addition, there is potential for chronic dietary exposure to
bentazon 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 bentazon
----------------------------------------------------------------------------------------------------------------
Surface       Ground
                                                 cPAD mg/kg/     % cPAD       Water        Water       Chronic
             Population Subgroup\1\                  day (Food)       EEC\2\       EEC\2\      DWLOC\3\
(ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population(48 states)                             0.003 10            8           20           95
----------------------------------------------------------------------------------------------------------------
Non-nursing infants                                    0.003 12            8           20           26
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                                 0.003 28            8           20           22
----------------------------------------------------------------------------------------------------------------
Children 7-12 years old                                0.003 16            8           20           26
----------------------------------------------------------------------------------------------------------------
Females 13--50 years old                               0.003 6.3           8           20           95
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroups chosen were U.S. population (70 kg. body weight assumed), the female subgroup with the
  highest food exposure (60 kg. body weight assumed),the infant/child subgroup with the highest food exposure
  (10 kg body weight assumed), and the other general population subgroups (70 kg body weight assumed) which have
  higher dietary exposure than the U.S. population.
\2\ Allowable Drinking Water Exposure (mg/kg/day) = cPAD (mg/kg/day) - Dietary Exposure from DEEM (mg/kg/day).
\3\ DWLOC(μg/L) = maximum water exposure (mg/kg/day) x body weight(kg)  water consumption (L) x
  10-3 mg/μg.

    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).
    Bentazon is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for bentazon.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 250,000 for females 13-50 years
old. These aggregate MOEs do not exceed the Agency's level of concern
for aggregate exposure to food and residential uses. In addition,
short-term DWLOCs were calculated and compared to the EECs for chronic
exposure of bentazon in ground and surface water. After calculating
DWLOCs and comparing them to the EECs for surface and ground water, EPA
does not expect short-term aggregate exposure to exceed the Agency's
level of concern, as shown in the following Table 4:

                     Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Bentazon
----------------------------------------------------------------------------------------------------------------
Aggregate     Surface       Ground
                                                Aggregate       Level of      Water        Water      Short-Term
            Population Subgroup               MOE\1\(Food + Concern\3\     EEC\4\       EEC\4\      DWLOC\5\
                                             Residential)\2\ (LOC)        (ppb)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                            250,000 1,000            8           20         3000
----------------------------------------------------------------------------------------------------------------
\1\ Residential Exposure = Oral exposure + Dermal exposure + Inhalation exposure.
\2\ Maximum Exposure (mg/kg/day) = NOAEL/Target MOE.
\3\ Basis for the target MOE: inter- and intra-species UFs totaling 100 x 10X (FQPA SF).
\4\ The crop producing the highest level was used.
\5\ DWLOC(μg/L) = maximum water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/
  μg.
\*\ Aggregate MOE = NOAEL + (Avg Food Exposure + Residential Exposure).
\*\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure).

    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Bentazon is currently registered for use(s) that could result in
intermediate-term residential exposure and the Agency has determined
that it is appropriate to aggregate chronic food and water and
intermediate-term exposures for bentazon.
    Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 8,200 for
females 13-50 years old, males 13-19 years old, and males 20+ years
old, and 1,900 for children 1-6 years old. These aggregate MOEs do not
exceed the Agency's level of concern for aggregate exposure to food and
residential uses. In addition, intermediate-term DWLOCs were calculated
and compared to the EECs for chronic exposure of bentazon in ground and
surface water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect intermediate-term
aggregate exposure to exceed the Agency's level of concern, as shown in
the following Table 5:

                 Table 5.--Aggregate Risk Assessment for Intermediate- Term Exposure to bentazon
----------------------------------------------------------------------------------------------------------------
Aggregate     Surface       Ground
                                              Aggregate       Level of      Water        Water     Intermediate-
           Population Subgroup              MOE\1\ (Food + Concern\3\     EEC\4\       EEC\4\    Term DWLOC\5\
                                           Residential)\2\     (LOC) (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old                            8,200 1,000            8           20           340
----------------------------------------------------------------------------------------------------------------
Children 1-6 years old                             1,900 1,000            8           20            64
----------------------------------------------------------------------------------------------------------------
Males 13-19 years old                              8,200 1,000            8           20           400
----------------------------------------------------------------------------------------------------------------
Males 20+ years old                                8,200 1,000            8           20           400
----------------------------------------------------------------------------------------------------------------
\1\ Residential Exposure = Oral exposure + Dermal exposure + Inhalation exposure.
\2\ Maximum Exposure (mg/kg/day) = NOAEL/Target MOE.
\3\ Basis for the target MOE: inter- and intra-species UFs totaling 100 x 10X (FQPA SF).
\4\ The crop producing the highest level was used.
\5\ DWLOC(μg/L) = maximum water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/
  μg.
\*\ Aggregate MOE = NOAEL (Avg Food Exposure + Residential Exposure).

\*\ Maximum Water Exposure (mg/kg/day) = Target Maximum Exposure - (Food Exposure + Residential Exposure).

    5. Aggregate cancer risk for U.S. population. Bentazon has been
classified as a Group E chemical (evidence of non-carcinogenicity for
humans) based upon lack of evidence of carcinogenicity in rats and
mice. Therefore no cancer risk is expected.
    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 bentazon residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for the determination of
residues of bentazon and its 6- and 8-hydroxy metabolites in/on plant
commodities. The Pesticide Analytical Method Volume II (PAM II) lists
Method II, a GLC method with flame photometric detection for the
determination of bentazon and its hydroxy metabolites in/on corn, rice,
and soybeans; the limit of detection (LOD) for each compound is 0.05
ppm. Method III, modified from Method II, is available for the
determination of bentazon and its hydroxy metabolites in/on peanuts and
seed and pod vegetables with a LOD of 0.05 ppm for each compound. These
methods are adequate to enforce the tolerances associated with this
petition.
    The method may be requested from: Francis Griffith, Analytical
Chemistry Branch, Environmental Science Center, Environmental
Protection Agency, 701 Mapes Road, Fort George G. Mead, MD 20755-5350;
telephone number: 410-305-20905; e-mail address:
griffith.francis@epa.gov.

B. International Residue Limits

    There is neither a Codex proposal, nor Canadian or Mexican Maximum
Residue Limit (MRL) for residues of bentazon and its metabolites in or
on clover.

C. Conditions

    1. Analytical analyses of bentazon and its regulated metabolites
using the FDA multiresidue protocols are required as part of the
conditional registration of bentazon on clover.
    2. The proposed use on clover is limited to the States of
Washington and Oregon and is limited to clover grown for seed.

V. Conclusion

    Therefore, the tolerances with regional registration are
established for combined residues of bentazon, (3-isopropyl-1H-2,1,3-
benzothiadiazin-4(3H)-one,2,2-dioxide) and its 6- and 8-hydroxy
metabolites, in or on clover, forage at 1.0 ppm, and clover, hay at 2.0
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-301215 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 April 8,
2002.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at 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 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-301215, 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 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 tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitledFederal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure "meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications." "Policies
that have federalism implications" is defined in the Executive Order
to include regulations that have "substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government." This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any "tribal
implications" as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure"meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications." "Policies that have tribal implications" is
defined in the Executive Order to include regulations that have
"substantial direct effects on one or more Indian tribes, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes." This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal government and Indian tribes, or on the distribution of power
and responsibilities between the Federal government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally

provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a "major rule" as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 30, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. Section 180.355 is amended by adding text to paragraph (c) to
read as follows:

Sec. 180.355  Bentazon; tolerances for residues.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration as defined in Sec. 180.1(n), are established for
combined residues of the herbicide, bentazon (3-isopropyl-1H-2, 1,3-
benzothiadiazin-4(3H)-one-2,2-dioxide) and its 6- and 8-hydroxy
metabolites in or on the following food commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Clover, forage..........................................             1.0
Clover, hay.............................................             2.0
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-2984 Filed 2-6-02; 8:45 am]