[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Rules and Regulations]
[Pages 5740-5749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2984]


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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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of 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

[[Page 5741]]

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

[[Page 5742]]

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 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

[[Page 5743]]

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

[[Page 5744]]

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 
g/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

[[Page 5745]]

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(g/L) = maximum water exposure (mg/kg/day) x body weight(kg)  water consumption (L) x
  10-3 mg/g.


[[Page 5746]]

    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(g/L) = maximum water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/
  g.
\*\ 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(g/L) = maximum water exposure (mg/kg/day) x body weight (kg) water consumption (L) x 10-3 mg/
  g.
\*\ 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

[[Page 5747]]

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: 
[email protected].

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 [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-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: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

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

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

[[Page 5748]]

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.

[[Page 5749]]


    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]
BILLING CODE 6560-50-S