[Federal Register Volume 66, Number 180 (Monday, September 17, 2001)]
[Rules and Regulations]
[Pages 48003-48011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23085]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301172; FRL-6803-2]
RIN 2070-AB78
Bentazon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance 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 Flax, seed at
1.0 ppm. BASF Corporation, Agricultural Products Division requested
this tolerance under the Federal Food, Drug, and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective September 17, 2001. Objections and
requests for hearings, identified by docket control number OPP-301172,
must be received by EPA on or before November 16, 2001.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301172 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: 703-305-6224; 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
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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://
[[Page 48004]]
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 theFederal Register listings
at http://www.epa.gov/fedrgstr/. 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-301172. 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 August 17, 1998 (63 FR 43937)(FRL-6018-
2), 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 6F4640, 3F4270) for tolerance by
BASF Corporation, Agricultural Products Division, P.O 13528, Research
Triangle Park, NC 27709-35281. This notice included a summary of the
petition prepared by BASF Corporation, the registrant. There were no
comments received in response to the notice of filing.
The petition requested that 40 CFR 180.355(a) be amended by
establishing a tolerance 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 Flax, seed at 1.0 part
per million (ppm).
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for combined residues of bentazon on Flax,
seed at 1.0 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by bentazon are
discussed in the Federal Register of March 8, 2000 (65 FR 12122)(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 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 intra species 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 (MOEcancer = point
[[Page 48005]]
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
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Exposure Scenario Dose (mg/kg/day) Endpoint Study
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Acute Dietary (Females 13-50 years Developmental NOAEL = Increased postimplantation Developmental
old) 100 loss, skeletal variations, Toxicity-Rat
UF = 100............. and reduced weight of fetuses
FQPA SF\*\ = 10...... at a LOAEL of 250 mg/kg/day.
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Acute RfD = 1 mg/kg
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Acute PAD = 0.1 mg/kg
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Acute Dietary (General None A dose and non-developmental None
Population) endpoint attributable to a
single exposure were not
identified in oral toxicity
studies.
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Risk Assessment is NOT
required.
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Chronic Dietary NOAEL = 3.2 A dose-dependent presence of One-Year Feeding
UF = 100............. feces with red areas in dogs Study-Dog
FQPA SF = 10......... at 13.1 mg/kg/day (LOAEL) and
52.3 mg/kg/day (HDT), and
slight to severe anemia at
the high dose.
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Chronic RfD = 0.03 mg/
kg/day
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Chronic PAD = 0.003
mg/kg/day
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Short-Term (Dermal) No systemic toxicity was seen at the Limit-Dose in a 21-day dermal toxicity
study in rabbits. Therefore, this risk assessment is NOT required.
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Intermediate-Term (Dermal)\a\ Oral NOAEL = 13.1 The presence of feces with red One-Year Feeding
MOE = 100 areas seen in dogs at weeks Study-Dog
(Occupational). 4, 6, and 12 at a LOAEL of
MOE = 1,000 52.3 mg/kg/day.
(Residential).
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Long-Term (Dermal)\a,d\ Oral NOAEL = 3.2 A dose-dependent presence of One-Year Feeding
MOE = 100 feces with red areas in dogs Study-Dog
(Occupational). at a LOAEL of 13.1 mg/kg/day
MOE = 1,000 (seen at week 33) and 52.3 mg/
(Residential). kg/day (HDT), and slight to
severe anemia at the high
dose.
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Short Term (Inhalation)\b\ Oral Developmental Increased postimplantation Developmental
NOAEL = 100 loss, skeletal variations, Toxicity-Rat
MOE = 100 and reduced weight of fetuses
(Occupational). at a LOAEL of 250 mg/kg/day.
MOE = 1,000
(Residential).
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Intermediate Term Oral NOAEL = 13.1 The presence of feces with red One-Year Feeding
(Inhalation)\c,d\ MOE = 100 areas seen in dogs at weeks Study-Dog
(Occupational). 4, 6, and 12 at a LOAEL of
MOE = 1,000 52.3 mg/kg/day.
(Residential).
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Long Term (Inhalation)\c,d\ Oral NOAEL=3.2 A dose-dependent presence of One Year Feeding
MOE = 100 feces with red areas in dogs Study-Dog
(Occupational). at a LOAEL of 13.1 mg/kg/day
MOE = 1,000 (seen at week 33) and 52.3 mg/
(Residential). kg/day (HDT), and slight to
severe anemia at the high
dose.
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\a\ A dermal absorption factor of 2% should be used for route-to-route extrapolation.
\b\ An inhalation absorption factor of 100% should be used for route-to-route extrapolation for short-term
inhalation risk assessment.
\c\ 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.
\d\ 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
[[Page 48006]]
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
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: an
Anticipated Residue was calculated for succulent peas using average
residue values (1.08 ppm) from the submitted crop field trials. Percent
CT information for several commodities was used. For all other
commodities 100% CT was assumed. 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.
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 this
tolerance.
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. For the chronic analysis, PCT information
was used for 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%). For
alfalfa, sorghum and potatoes, which have %CT estimates of zero, a
value of 1% CT was used in the 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,
and tolerance level residues were used for all crops.
The Agency believes that the three conditions 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 (bentazon + AIBA) concentrations in
ground water used as drinking water are not likely to exceed 4.25 parts
per billion (ppb). As reported in the 1994 bentazon RED, bentazon
concentrations (excluding degradation products) in ground water are
higher (20 to 120 ppb) when compared to SCI-GROW model predictions. The
maximum concentration of bentazon (120 ppb) was observed in shallow
groundwater samples near greens and tees in a United States Geological
Survey (USGS) and the Florida Department of Environmental Protection
(FDEP) monitoring study. Since the monitoring data indicate a higher
concentration than the SCI-GROW screening model, EPA used the 20 ppb as
the representative national Tier 1 ground water screening concentration
for bentazon.
Tier II 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
[[Page 48007]]
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 Pesticide Root Zone/Exposure Analysis Modeling System
(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 2 model) for a screening-level assessment for surface water.
The GENEEC model is a subset of the PRZM/EXAMS model that uses a
specific high-end runoff scenario for pesticides. GENEEC incorporates a
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir
environment in place of the previous pond scenario. The PRZM/EXAMS
model includes a percent crop area factor as an adjustment to account
for the maximum percent crop coverage within a watershed or drainage
basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use 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 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: Although bentazon is a registered herbicide for use on
turf and ornamentals, short-term non-dietary ingestion exposure for
toddlers is not assessed since EPA determined that there is no acute
dietary or oral endpoint applicable to infants and children.
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. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. Both the rat developmental
and reproductive toxicity studies indicate increased susceptibility
from in utero and post natal exposure to bentazon. The available
developmental toxicity data in rabbits did not provide an indication of
increased susceptibility from in utero exposure to bentazon.
3. Conclusion. There is a complete toxicity data base 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:
i. Evidence of increased susceptibility following in utero exposure
to bentazon in the prenatal developmental toxicity study in rats in the
absence of maternal toxicity.
ii. 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
[[Page 48008]]
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, the USEPA Office of Pesticide Programs (OPP)
concludes with reasonable certainty that exposures to the pesticide in
drinking water (when considered along with other sources of exposure
for which OPP has reliable data) would not result in unacceptable
levels of aggregate human health risk at this time. Because OPP
considers the aggregate risk resulting from multiple exposure pathways
associated with a pesticide's uses, levels of comparison in drinking
water may vary as those uses change. If new uses are added in the
future, OPP will reassess the potential impacts of 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% 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 Acute
Population Subgroup\1\ aPAD (mg/ % aPAD Water EEC Water DWLOC\2\
kg) (Food) (ppb) EEC(ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years 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 less than or equal to 10% of the cPAD for the
U.S. population, 12% of the cPAD for non-nursing infant and 28% of the
cPAD for children 1-6 years old.
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/ % Water Water Chronic
Population Subgroup\1\ day cPAD(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
Males 13-19 years old 0.003 10 8 20 95
Males 20+ years old 0.003 6.7 8 20 98
Seniors 55+ years old 0.003 6.2 8 20 99
----------------------------------------------------------------------------------------------------------------
\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
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
[[Page 48009]]
concern, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Short-Term Exposure to Bentazon
----------------------------------------------------------------------------------------------------------------
Aggregate
Aggregate Level of Surface Water Ground Water Short-Term
Population Subgroup MOE\1\ (Food + Concern\3\ EEC\4\ (ppb) EEC\4\ (ppb) DWLOC\5\ (ppb)
Residential)\2\ (LOC)
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old 250,000 1,000 8 20 3,000
----------------------------------------------------------------------------------------------------------------
\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 + 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) (60 kg. body weight assumed) 2
(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 Expoxure)
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
males 20+ years old, females 13-50 years old and males 13-19 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)
----------------------------------------------------------------------------------------------------------------
Males 20+ years old 8,200 1,000 8 20 400
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
----------------------------------------------------------------------------------------------------------------
\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
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.
B. International Residue Limits
There is a Codex maximum residue limit (MRL) of 0.1 ppm for
bentazon and its metabolites established in/on linseed. Therefore, a
compatibility issue is relevant to the proposed flax, seed tolerance.
Harmonization of the U.S. tolerance will not be possible as the use
pattern proposed in this petition may result in residues which exceed
the Codex MRL.
C. Conditions
Analytical analyses of bentazon and its regulated metabolites using
the FDA multiresidue protocols are required as part of the conditional
registration of bentazon on flax.
[[Page 48010]]
V. Conclusion
Therefore, the tolerance is established for combined residues of
bentazon, (3-isopropyl-H-2,1,3-Benzothiadiazin-4 (3H)-one-2,2-dioxide)
and its 6- and 8-hydroxy metabolites in or on flax, seed at 1.0 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-301172 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
16, 2001.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at [email protected],
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket control number OPP-301172, 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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any other 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
[[Page 48011]]
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: September 7, 2001.
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 revising the term ``commodity'' in
the introductory text to paragraph (a) to read ``commodities'' and by
alphabetically adding the commodity ``flax, seed'' to the table in
paragraph (a)(1) to read as follows:
Sec. 180.355 Bentazon; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Flax, seed..................................... 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 01-23085 Filed 9-14-01; 8:45 am]
BILLING CODE 6560-50-S