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Bentazon - Pesticide Tolerance 2/00

[Federal Register: March 8, 2000 (Volume 65, Number 46)]
[Rules and Regulations]
[Page 12122-12129]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr00-19]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300978-FRL-6492-7]
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 succulent peas.
In addition the tolerance expression for animal commodities (meat,
milk, poultry, and eggs) established in 40 CFR 180.355(a) is being
corrected to that of the combined residues of bentazon and its
metabolite 2-amino-N-isopropyl benzamine (AIBA). BASF Corporation
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 March 8, 2000. Objections and
requests for hearings, identified by docket control number OPP-3000978,
must be received by EPA on or before May 8, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300978 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, Ariel Rios Building, 1200 Pennsylvania
Avenue, NW, Washington, DC 20460; telephone number: (703) 305-6224; and
e-mail address: miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

------------------------------------------------------------------------
                                                 Examples of Potentially
              Categories                NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                   111  Crop production
                                           112  Animal production
                                           311  Food manufacturing
                                         32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations" and then look up the entry for this document under the
"Federal Register--Environmental Documents." You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300978. 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 and 3F4270 for a
tolerance by BASF Corporation. 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 and its 6- and 8-hydroxy metabolites, in or on succulent peas
at 3.0 part per million (ppm). Tolerances have been established under
40 CFR 180.355(a) for combined residues of bentazon and its 6- and 8-
hydroxy metabolites in/on succulent peas at 0.5 ppm and pea forage at 3
ppm to support a 2  x  1 lb ai/A (pounds active ingredient per acre),
30-day preharvest interval (PHI) use pattern. The new tolerance is
proposed to support a 2  x  1 lb ai/A, 10-day PHI use pattern.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical

[[Page 12123]]

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 and its 6-
and 8-hydroxy metabolites in/on succulent peas at 3.0 ppm. EPA's
assessment of the dietary 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 this unit.
    1. Acute toxicity data for bentazon show that this chemical is not
acutely toxic by the oral, inhalation, or dermal routes of exposure
(Toxicity Categories III and IV). It is moderately irritating to the
eye (Toxicity Category II) and slightly irritating to the skin
(Toxicity Category IV). Bentazon is also a dermal sensitizer.
    2. A 21-day dermal toxicity study in rabbits was conducted at doses
of 0, 250, 500, or 1,000 mg/kg/day. The no observed adverse effect
level (NOAEL) is 1,000 mg/kg/day, HDT (highest dose tested). The lowest
observed adverse effect level (LOAEL) is greater than 1,000 mg/kg/day.
    3. A 13-week feeding study in rats was conducted at doses of 0,
400, 1,200, or 3,600 ppm; equivalent to 0, 25.3, 77.8, or 243.3 mg/kg/
day for males and 0, 28.9, 86.1, or 258.3 mg/kg/day for females. The
NOAEL is 77.8 mg/kg/day. The LOAEL is 243.3 mg/kg/day for males and
258.3 mg/kg/day for females based on depressed mean body weights in
females, a slight increase in food consumption in males, increased
thromboplastin and prothrombin times (males only), and increased kidney
and liver weights.
    4. A chronic feeding study in dogs was conducted at doses of 0,
100, 400, or 1,600 ppm; equivalent to 0, 3.2, 13.1, or 52.3 mg/kg/day.
The NOAEL is 3.2 mg/kg/day. The LOAEL is 13.1 mg/kg/day based on a
dose-dependent presence of feces with red areas in dogs at 13.1 mg/kg/
day (400 ppm) and 52.3 mg/kg/day (1600 ppm) and slight to severe anemia
at the high dose.
    5. A chronic feeding/carcinogenicity study in rats was conducted at
doses of 0, 200, 800, or 4,000 ppm; equivalent to 0, 9, 35, or 180 mg/
kg/day in males and 0, 11, 45, or 244 mg/kg/day in females. The NOAEL
is 9/11 mg/kg/day, in males/females. The LOAEL is 35/45 mg/kg/day, in
males/females, based on increased water consumption, changes in
urinalysis and hematology/coagulation parameters, and decreased
absolute and relative thyroid weight. No evidence of carcinogenicity
was observed.
    6. A oncogenicity study in mice was conducted at doses of 0, 100,
400, or 2000 ppm; equivalent to 0, 12, 47, or 242 mg/kg/day in males
and 0, 12, 48, or 275 mg/kg/day in females. The NOAEL is 12 mg/kg/day.
The LOAEL is 47/48 mg/kg/day in males/females, based on increased
prothrombin time, increased liver and kidney weights, calcification of
the tunica albuginea, and islet cell hyperplasia of the pancreas. No
evidence of carcinogenicity was observed.
    7. A developmental study in rats was conducted at doses of 0, 40,
100, or 250 mg/kg/day. The maternal NOAEL is 250 mg/kg/day (HDT). The
maternal LOAEL is greater than 250 mg/kg/day. The developmental NOAEL
is 100 mg/kg/day. The developmental LOAEL is 250 mg/kg/day, based on
increased postimplantation loss, skeletal variations (incomplete or
absent ossification in the phalangeal nucleii of the extremities, the
sternebrae and cervical vertebrae), and reduced body weights or fetuses
surviving to day 21.
    8. A developmental study in rabbits was conducted at doses of 0,
75, 150, or 375 mg/kg/day. The maternal/developmental NOAEL is 150 mg/
kg/day. The maternal/developmental LOAEL is 375 mg/kg/day (HDT), based
on doe with partial abortion, embryonic resorptions, and no living
fetuses.
    9. A 2-generation reproduction toxicity study in rats was conducted
at doses of 0, 200, 800, or 3,200 ppm; equivalent to 0, 15, 62, or 249
mg/kg/day. The parental systemic NOAEL is 62 mg/kg/day. The parental
systemic LOAEL is 249 mg/kg/day, based on increased incidences of
kidney mineralization and liver microgranuloma. The reproductive NOAEL
is 15 mg/kg/day. The reproductive LOAEL is 62 mg/kg/day, based on
reduced pup growth (body weight gain) during lactation.
    10. There is no concern for mutagenic activity in several studies,
including: Salmonella spp., in vitro mammalian cell gene mutation
assays, in vivo mouse bone marrow micronucleus assay, and an
unscheduled DNA synthesis assay.
    11. A rat metabolism study with oral dosing showed that parent
bentazon was the major metabolite found in urine, amounting to 77.37-
91.02% of the dose. Another metabolism study demonstrated that the
absorption and excretion of bentazon or its sodium salt in male rats
after oral administration is rapid and essentially equivalent. No sex
differences in the absorption, metabolism or excretion of sodium
bentazon are apparent based or equivalent excretion half-lives (4
hours), pattern of excretion (greater than 90% in urine) or urinary
metabolite identification (greater than 80% as free acid).
    12. A dermal penetration study in rats was conducted at doses of
0.12, 1.2, 12, or 120 mg/kg. Single topical application of radioactive
sodium bentazon did not appear to significantly penetrate the skin
since a maximum of only 1-2% of the radioactivity was recovered
(primarily in the urine) at 72 hours. Negligible amounts of dermally
applied radioactivity were retained in the liver, kidneys, G.I. tract
and carcass. For risk assessment purposes, dermal penetration is
estimated to be 1-2%.

[[Page 12124]]

B. Toxicological Endpoints

    1. Acute toxicity. An acute reference dose (aRfD) of 1 mg/kg/day
was established for the subpopulation group, females 13-50 years old
only, based on a no-observed-adverse-effect level (NOAEL) of 100 mg/kg/
day from a developmental toxicity study in the rat. The effects
observed at the next higher dose level of 250 mg/kg/day (the highest
dose tested) were an increase in postimplantation loss, skeletal
variations, and reduced weight of fetuses. These effects are presumed
to occur after a single exposure in utero and, therefore, are
considered to be appropriate. A 10x FQPA safety factor is applied to
females 13-50 years old, because there was evidence of increased
susceptibility in the developmental toxicity study in rats and in the
two-generation reproduction toxicity study in rats. An uncertainty
factor of 100 is used to account for inter-species differences and
intra-species variability. Therefore, the aPAD (acute population
adjusted dose) is 0.1 mg/kg/day for females 13-50 years old. An acute
dose and endpoint were not selected for the general U.S. population
(including infants and children) because there were no effects observed
in oral toxicology studies, including maternal toxicity in the
developmental toxicity studies in rats and rabbits, that are
attributable to a single exposure (dose).
    2. Short- and intermediate-term toxicity. A short-term dermal dose/
endpoint was not identified since no dermal or systemic toxicity was
seen at the limit dose of 1,000 mg/kg/day in a 21-day dermal toxicity
study in rabbits. An intermediate-term dermal endpoint was chosen from
a one-year feeding study in dogs. A NOAEL of 13.1 mg/kg/day was chosen
based on the presence of feces with red areas seen in dogs at weeks 4,
6, and 12 at a LOAEL of 52.3 mg/kg/day. A long-term dermal endpoint was
chosen from a one-year feeding study in dogs. A NOAEL of 3.2 mg/kg/day
was selected based on a dose-dependent presence of feces with red areas
in dogs at the LOAEL of 13.1 mg/kg/day (400 ppm). EPA determined that
since oral NOAELs were selected, a dermal absorption (DA) factor of 2%,
obtained from a dermal penetration study, should be used for the risk
assessment.
    No appropriate inhalation studies were available for endpoint
selection; therefore, EPA selected oral NOAELs for inhalation exposure
risk assessment. For margin of exposure (MOE) calculations, the short-
term inhalation exposure NOAEL is 100 mg/kg/day (from a developmental
toxicity study in rats, therefore, use 100% inhalation absorption).
Dermal exposure can not be combined with inhalation, because a dose/
endpoint (hazard) was not identified for short-term dermal exposure
risk assessment. The intermediate- and long-term inhalation exposure
NOAELs are 13.1 mg/kg/day and 3.2 mg/kg/day, respectively, from a
chronic dog study. For intermediate- and long-term inhalation exposure
risk assessments, the dermal and inhalation exposures can be combined
(using 100% absorption for inhalation and 2% absorption for dermal)
because the doses selected are oral equivalent doses and the same toxic
effect was observed (feces with red areas).
    3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for at 0.03 milligrams/kilograms/day (mg/kg/day). This is RfD based on
the NOAEL of 3.2 mg/kg/day in the one year dog feeding study and an
uncertainty factor of 100 (10X for inter-species differences and 10X
for intra-species variability). The LOAEL in the study was based on
dose-dependent presence of feces with red areas in dogs at 13.1 mg/kg/
day (seen at week 33) and at 52.3 mg/kg/day (HDT), and slight to severe
anemia at the high dose. Using the 10x FQPA safety factor, the chronic
population adjusted dose (cPAD) for bentazon is 0.003 mg/kg/day.
    4. Carcinogenicity. Bentazon has been classified as a Group "E"
chemical (evidence of non-carcinogenicity for humans) based upon a lack
of evidence of carcinogenicity in two adequate studies (rats and mice).

C. Exposures and Risks

    1. 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. Risk
assessments were conducted by EPA to assess dietary exposures from as
follows:
    A refined chronic dietary exposure analysis (Tier 3) was performed
using anticipated residues (ARs) for succulent peas and tolerance level
residues for all other commodities for the general U.S. population and
all population subgroups. For the chronic analysis, percent crop
treated (%CT) information was used for several commodities.
    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.
    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

[[Page 12125]]

underestimate an individual's acute dietary exposure. The Agency is
reasonably certain that the percentage of the food treated is not
likely to be underestimated. 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.
    i. Acute exposure and risk. 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 1-day or single exposure. The acute dietary analysis for females
13-50 years old (the subpopulation of concern) assumed published and
proposed tolerance levels and 100% crop treated information for all
commodities (Tier I). For all the females 13-50 years old subgroups, 5%
or less of the aPAD is occupied by dietary exposure from food. Results
of the acute analysis indicate that the acute dietary risk residues in
food associated with existing and proposed uses of bentazon do not
exceed EPA's level of concern.
    ii. Chronic exposure and risk. A refined chronic dietary exposure
analysis (Tier 3) was performed using anticipated residues for
succulent peas and tolerance level residues for all other commodities
for the general U.S. population and all population subgroups. For the
chronic analysis, percent crop treated information was used for several
commodities. The percent chronic population adjusted dose (% cPADs) for
all subgroups were less than 100%, with the highest being 28% for the
children 1-6 years subgroup. Results of the chronic analysis indicate
that the chronic dietary risk from from residues in food associated
with the existing and proposed uses of bentazon do not exceed EPA's
level of concern.
    2. From drinking water. SCI-GROW (Screening Concentration in Ground
Water) modeling indicates that bentazon residue (bentazon + AIBA )
concentrations in groundwater used as drinking water are not likely to
exceed 4.25 ppb. The other regulated bentazon metabolites (6-hydroxy
and 8-hydroxy bentazon) have not been found in environmental fate
studies. Limited monitoring data indicated a range of bentazon
concentrations (excluding degradation products) in groundwater of 20 to
120 ppb. Because monitoring data indicate a higher concentration than
the SCI-GROW screening model, EPA used the 20 ppb as the environmental
exposure concentration (EEC) for both acute and chronic scenarios. The
EEC for surface water (from EPA's Pesticide Root Zone Model-EXAMS
modeling) is 41 ppb for the peak (acute) and 8 ppb for the 36-year
annual mean (chronic). The surface and ground water estimates were used
to compare against back-calculated drinking water levels of comparison
(DWLOCs) for aggregate risk assessments.
    i. Acute exposure and risk. For the acute scenario, the DWLOC is
2800 ppb for females (13+/nursing).
    ii.Chronic exposure and risk. For the chronic scenario, the DWLOCs
are 95, 82, 22, 94, and 95 ppb for the US population, females (13+/
nursing), children (1-6 years), Hispanics and males (13-19 years),
respectively.
    3. From non-dietary exposure. 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.
    Short- and intermediate-term exposure and risk. 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 a concern because EPA determined that there is no acute dietary or
oral endpoint applicable to infants and children. However,
intermediate-term, non-dietary ingestion exposure to toddlers playing
on treated turf is possible and was assessed using the intermediate-
term endpoint identified from the one-year dog feeding study.
Intermediate-term exposure is not expected for the ornamental use. The
level of concern for residential exposures to bentazon is for MOE's
less than 1,000.
    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 HED Standard Operating Procedures (SOPs) for Residential Exposure
Assessments. Because bentazon is applied no more than twice per year,
only short-term exposure is expected for the residential handler.
Because a dermal endpoint of concern for the short-term duration was
not identified, only inhalation exposure estimates are relevant.
Assuming that a homeowner treats his lawn and ornamental plants on the
same day, the aggregate inhalation short-term MOE is 500,000 for the
residential handler. This estimate indicates that the potential handler
risks from residential uses of bentazon do not exceed EPA's level of
concern.
    Environmental fate data indicate that bentazon is moderately
resistant to degradation (t1/2 = 24-65 days). Due to the
length of time bentazon is expected to remain in the environment, both
short- and intermediate-term residential post-application exposures are
expected. For toddlers playing on treated turf, the oral intermediate-
term endpoint was used to assess toddler incidental ingestion
exposures. Based on the residential use pattern, no long-term post-
application residential exposure is expected. Short-term, non-dietary
oral exposures to the toddler were not assessed because the subgroup of
concern was identified as females 13-50 years old. This endpoint is not
applicable to the infant and children population subgroups.
Intermediate-term, post-application exposure is not expected from the
ornamental use of bentazon.
    Changes to the Residential SOPs have been proposed that alter the
residential post-application scenario assumptions. The proposed
assumptions are expected to better represent residential exposure and
are still considered to be high-end, screening level assumptions.
Therefore, EPA has deviated from the current Residential SOP
assumptions and uses the proposed assumptions to calculate exposure
estimates.
    The dermal post-application exposure from the turfgrass use for the
adult results in an MOE of 9,100. The MOEs for post-application
exposures for the toddler are calculated as 6,400 and 3,500 for dermal
and hand-to-mouth exposures, respectively. The aggregate intermediate
MOE for post-application residential exposure to toddlers is 2,200.
Therefore, all residential post-application exposure estimates are well
below EPA's level of concern. Because these estimates were calculated
using

[[Page 12126]]

screening-level assumptions, EPA believes that the actual risks will be
lower. For the intermediate-term, typical lawn maintenance practices
such as mowing and watering are expected to expedite the dissipation of
bentazon on turfgrass. Therefore, with less residue available,
potential incidental hand-to-mouth exposures are expected to be
substantially lower.
    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. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. Acute risk estimates from aggregate exposure to
bentazon in food and water are below EPA's level of concern. For Tier 1
acute dietary exposure analysis, EPA assumed that 100% of the crops
treated with bentazon and that residues equaled the tolerance level.
For all females 13-50 years old subgroups, less than or equal to 5% of
the aPAD is occupied by dietary exposure from food. The acute dietary
risk from food associated with the existing and proposed uses of
bentazon is below EPA's level of concern. The estimated average
concentrations of bentazon in surface and ground water are less than
EPA's levels of comparison for bentazon in drinking water as a
contribution to acute aggregate exposure.
    2. Chronic risk. Chronic (Non-Cancer) Aggregate Risk estimates are
below EPA's level of concern. The chronic dietary exposure analysis for
residues in food incorporated anticipated residues for succulent peas
and assumed tolerance level residues for all other commodities. Percent
CT information was used for several commodities. The %cPADs for all
subgroups were less than 100%, with the highest being 28% for the
children (1-6 years old) subgroup. Thus, the chronic dietary risk
estimates from food associated with existing and proposed uses of
bentazon do not exceed EPA's level of concern. For ground and surface
water, the estimated average concentrations of bentazon are less than
EPA's levels of comparison for bentazon in drinking water as a
contribution to chronic aggregate exposure.
    3. Short- and intermediate-term risk. Aggregate short-term risk
estimates are below EPA's level of concern. In aggregating short-term
risk, EPA considered background chronic dietary exposure (food +
drinking water) and short term inhalation exposures from residential
uses. Because a dermal endpoint of concern for the short-term duration
was not identified, only inhalation exposure estimates are relevant for
the adult handler. Short-term inhalation exposure may occur for a
homeowner treating turf and ornamentals on the same day. The total
short-term food and residential aggregate MOE value is 220,000. As this
MOE is greater than 1,000, the short-term food and residential
aggregate risk estimate is below EPA's level of concern. For surface
and ground water, the estimated average concentrations of bentazon are
less than EPA's levels of comparison for bentazon in drinking water as
a contribution to short-term aggregate exposure.
    Aggregate intermediate-term risk estimates are below EPA's level of
concern for adults. In aggregating intermediate-term risk, EPA
considered background chronic dietary exposure (food + drinking water)
and intermediate-term dermal exposures from residential uses. For
adults, dermal post-application exposures may result from dermal
contact with treated turf. For adults, the total food and residential
intermediate-term aggregate MOE is 7,600. As this value is greater than
1,000, the intermediate-term aggregate risk estimate is below EPA's
level of concern. For surface and ground water, the estimated average
concentrations of bentazon are less than EPA's levels of comparison for
bentazon in drinking water as a contribution to intermediate-term
aggregate exposure.
    4. Aggregate cancer risk for U.S. population. A cancer risk
assessment was not done. Bentazon is classified as a Group E chemical
(evidence of non-carcincinogenicity for humans) based upon lack of
evidence of carcinogenicity in rats and mice.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to bentazon residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of bentazon, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
    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 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. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Developmental toxicity studies. Two studies were described in
Toxicology Profile (see Unit III.A. Tox profile).
    iii. Reproductive toxicity study. A reproductive toxicity study was
described in the Toxicology Profile (see Unit III.A. Tox profile).
    iv. Prenatal and postnatal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity of bentazon is complete
with respect to current data requirements.

[[Page 12127]]

There was evidence of increased susceptibility followingin utero
exposure to bentazon in the prenatal developmental toxicity study in
rats and there was quantitative evidence of increased susceptibility
following pre-/postnatal exposure to bentazon in the 2-generation
reproduction study in rats.
    v. 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 for bentazon
due to the increased pre-/postnatal susceptibility. The FQPA Safety
Factor for bentazon is applicable to females 13-50 years old only for
acute dietary and residential exposure assessments because increased
susceptibility was demonstrated in the developmental study in rats
which is designed to evaluate chemical effects on the mother and fetus
from the time of implantation of the fertilized egg in the uterus
through the end of gestation. The safety factor is also applicable to
all population subgroups for chronic dietary and residential exposure
assessments because increased susceptibility was demonstrated in the 2-
generation reproduction study (which is designed to assess the effects
of the pesticide on male and female reproductive processes, from egg
and sperm production and mating through pregnancy, birth, nursing,
growth and development, and maturation).
    2. Acute risk. An acute endpoint was not identified and this risk
assessment was not required.
    3. Chronic risk.Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to bentazon from food
will utilize 28% of the chronic PAD for children (1-6 years old). EPA
generally has no concern for exposures below 100% of the chronic PAD
because the chronic PAD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to bentazon
in drinking water and from non- dietary, non-occupational exposure, EPA
does not expect the aggregate exposure to exceed 100% of the chronic
PAD.
    4. Short- or intermediate-term risk. Although bentazon a registered
herbicide for use on turf and ornamentals, short-term non-dietary
ingestion exposure for toddlers is not assessed because EPA determined
that there is no acute dietary or oral endpoint applicable to infants
and children.
    Aggregate intermediate-term risk estimates are below EPA's level of
concern for infants and children. In aggregating intermediate-term
risk, EPA considered background chronic dietary exposure (food +
drinking water) and intermediate-term, non-dietary oral and dermal
exposures from residential uses. For toddlers, dermal and non-dietary
oral postapplication exposures may result from dermal contact with
treated turf as well as hand-to-mouth transfer of residues from
turfgrass. For infants and children, the total food and residential
intermediate-term aggregate MOE is 2,000. As this value is greater than
1,000, the intermediate-term aggregate risk estimate is below EPA's
level of concern. For surface and ground water, the estimated average
concentrations of bentazon are less than EPA's levels of comparison for
bentazon in drinking water as a contribution to intermediate-term
aggregate exposure.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure bentazon to residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The qualitative nature of the residue in plants is considered to be
adequately understood. Radiolabelled studies conducted at rates of up
to 2.5 lb ai/A on beans, corn, soybeans, rice and wheat indicate that
bentazon is readily absorbed from foliage, roots and seeds, and
translocates in some plant types. Bentazon is rapidly metabolized,
conjugated and incorporated into natural plant constituents. Metabolism
involves the hydroxylation of bentazon at the 6- and 8-positions. The
terminal residues of regulatory concern are bentazon, 6-hydroxy
bentazon, and 8-hydroxy bentazon. As there are no livestock feed items
associated with succulent peas, issues pertaining to the nature of the
residue in animals are not germane to this regulation.

B. 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 Manual (PAM) Vol. II lists Method
II, a gas liquid chromatography (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 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 limit of detection of 0.05
ppm for each compound.

C. Magnitude of Residues

    Ten field residue trials were conducted in seven different states
with a distribution which corresponds well with the suggested growing
region for succulent garden peas. The data indicated that combined
residues of bentazon and its 6- and 8-hydroxy metabolites will not
exceed the proposed tolerance. BASF provided data only on green peas.
The raw agricultural commodity (RAC) analyzed in these trials was the
succulent seeds with the pods. At the time these trials were conducted
in 1993, succulent seeds with pods was the appropriate RAC. In 1995,
the guidelines were revised and the RAC was redefined as edible-podded
peas and succulent shelled peas. Thus, the submitted field trials do
not fulfill current guidelines. BASF is required to perform three (3)
edible-podded pea trials. The additional studies will satisfy the new
guidelines and provide EPA with confirmatory data. EPA is proceeding
with this tolerance while the additional trials are conducted because
the available data are adequate to make a safety determination.

D. International Residue Limits

    There is a Codex Maximum Residue Limit (MRL) of 0.2 ppm for
bentazon and its metabolites established in/on garden peas (young
pods), a Canadian MRL for parent only of 0.1 ppm (negligible)
established in/on peas, and a Mexican limit for parent (presumed) of
0.05 ppm established in/on green peas. Therefore, a compatibility issue
is relevant to the proposed tolerance. Harmonization of the 3.0 ppm
U.S. tolerance will not be possible as the use pattern proposed on the
Basagran Herbicide label will result in residues which greatly exceed
the Codex MRL. EPA thus suggests that BASF submit the residue data and
Good Agricultural Practice (GAP) to Codex once the U.S. registration
and tolerance are approved.

E. Rotational Crop Restrictions

    Currently, there are no plantback restrictions on the Basagran
Herbicide label. Confined rotational crop data indicate that bentazon
residues may be taken up by rotational crops (39 to 102 day plantback
intervals), and that field rotational crop studies are needed for the
purposes of reregistration in order to determine if plantback
restrictions for bentazon end-use products are needed.

[[Page 12128]]

If plantback restrictions are needed based upon these studies then the
Herbicide label will be revised.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
bentazon and its 6- and 8-hydroxy metabolites in pea, succulent at 3.0
ppm. In addition, the tolerance expression for animal commodities in 40
CFR 180.355(a) is corrected as the combined residues of bentazon and
its metabolite 2-amino-N-isopropyl benzamide (AIBA).

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-300978 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 May 8,
2000.
    1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C-400 , 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."
    Pursuant to FFDCA section 408(m)(1), EPA is authorized to waive any
fee requirement "when in the judgment of the Administrator such a
waiver or refund is equitable and not contrary to the purpose of this
subsection." For additional information regarding the waiver of these
fees, you may contact James Tompkins by phone at (703) 305-5697, by e-
mail at tompkins.jim@epa.gov, or by mailing a request for information
to Mr. Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. N.W., 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.1.,
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-300978, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460. In
person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 5.1/6.1 file format or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. 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). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require OMB review or
any Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and

[[Page 12129]]

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). Because
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).

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: February 24, 2000.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

PART 180--[AMENDED]

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

    Authority: 21 U.S.C. 321(q), (346a) and 371.
    2. Section 180.355 is amended in paragraph (a) by revising the
introductory text and redesignating it as paragaph (a)(1), by revising
the entry for "pea, succulent" in the table in newly designated
paragraph (a)(1), by removing from the table in newly designated
paragraph (a)(1) the entries for cattle, fat; cattle, meat byproducts;
cattle, meat; egg; goats, fat; goats, mbyp; goats, meat; hogs, fat;
hogs, mbyp; hogs, meat; milk; poultry, fat; poultry, meat byproducts;
poultry, meat; sheep, fat; sheep, mbyp; and sheep, meat, and by adding
new paragraph (a)(2). The additions and revision read as follows:

Sec. 180.355  Bentazon; tolerances for residues.

    (a) General. (1) Tolerances are established for the 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 commodity:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                  *        *        *        *        *
Pea, succulent.............................................          3.0
                  *        *        *        *        *
------------------------------------------------------------------------

    (2) Tolerances are 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:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.05
Cattle, mbyp...............................................         0.05
Cattle, meat...............................................         0.05
Eggs.......................................................         0.05
Goats, fat.................................................         0.05
Goats, mbyp................................................         0.05
Goats, meat................................................         0.05
Hogs, fat..................................................         0.05
Hogs, mbyp.................................................         0.05
Hogs, meat.................................................         0.05
Milk.......................................................         0.02
Poultry, fat...............................................         0.05
Poultry, mbyp..............................................         0.05
Poultry, meat..............................................         0.05
Sheep, fat.................................................         0.05
Sheep, mbyp................................................         0.05
Sheep, meat................................................         0.05
------------------------------------------------------------------------
    *        *        *        *        *
[FR Doc. 00-5634 Filed 3-7-00; 8:45 am]
BILLING CODE 6560-50-F