[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Rules and Regulations]
[Pages 12122-12129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5634]


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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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

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

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

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' 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 [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. 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: [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 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