[Federal Register Volume 66, Number 213 (Friday, November 2, 2001)]
[Notices]
[Pages 55660-55664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27600]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1047; FRL-6806-1]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1047, must be 
received on or before December 3, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1047 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-7610; 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
           Categories                    NAICS            potentially
                                                       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 PF-1047. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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 Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1047 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-1047. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI,

[[Page 55661]]

please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

     Environmental protection, Agricultural commodities, Feed 
additives, Food additives, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: October 24, 2001.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

 Interregional Research Project Number 4

6E4703

    EPA has received a pesticide petition 6E4703 from the Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North 
Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a 
tolerance for combined residues of the herbicide, bentazon (3-
isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-dioxide) and its 6- 
and 8-hydroxy metabolites in or on the raw agricultural commodities 
clover forage at 1.0 part per million (ppm) and clover hay at 2.0 ppm. 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition. 
Bentazon is manufactured by the BASF Corporation, Agricultural Products 
Division.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residue in 
plants is adequately understood. Bentazon is rapidly metabolized, 
conjugated and incorporated into natural plant constituents. Metabolism 
involves the hydroxylation of bentazon at the 6- and 8-position. The 
terminal residues of regulatory concern are bentazon, 6-hydroxy 
bentazon, and 8-hydroxy bentazon (as specified in 40 CFR 180.355(a)).
    2. Analytical method. 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 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.
    3. Magnitude of residues. A total of 2 field residue trials were 
conducted on red clover in 1993 in Oregon. A single application of 
Basagran herbicide was made to clover at a rate of either 1.0 lb. 
active ingredient per acre (a.i./acre) (0.5X) or 2.0 lb/a.i./acre (1X). 
The spray volume was 20 gal/acre. An adjuvant (R-11) was included in 
all treatments at 2 oz./acre. Samples of forage and hay were harvested 
from each treated plot 36 days after treatment. Samples were analyzed 
for the combined residues of bentazon and its 6- and 8-hydroxy 
metabolites. Analysis of the treated samples showed that the maximum 
total residue was 0.77 ppm in forage and 1.19 ppm in hay.

B. Toxicological Profile

    1. Acute toxicity. 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. Genotoxicty. Bentazon was not mutagenic in the tests for gene 
mutations, which were reverse mutation assays in S. typhimurium and in 
E. coli WP2 uvrA as well as forward mutation assays with in vitro 
Chinese hamster ovary cell (HGPRT) cultures. Bentazon was also negative 
in the mouse micronucleus test for assessing structural chromosomal 
aberrations and the unscheduled DNA synthesis assay with primary mouse 
hepatocytes for detecting DNA damage.
    3. Reproductive and developmental toxicity. A developmental study 
in rats was conducted at doses of 0, 40, 100, or 250 milligrams per 
kilogram per day (mg/kg/day). The maternal NOAEL (no observed adverse 
effect level) is 250 mg/kg/day, HDT (highest dose tested). The maternal 
LOAEL (lowest observed adverse effect level) 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.
    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

[[Page 55662]]

on doe with partial abortion, embryonic resorptions, and no living 
fetuses. 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.
    4. Subchronic toxicity. A 21-day dermal toxicity study in rabbits 
was conducted at doses of 0, 250, 500, or 1,000 mg/kg/day. The NOAEL is 
1,000 mg/kg/day (HDT). The LOAEL is greater than 1,000 mg/kg/day. 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.
    5. Chronic toxicity. 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 (1,600 ppm) and slight to 
severe anemia at the high dose. 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. An oncogenicity study in mice 
was conducted at doses of 0, 100, 400, or 2,000 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.
    6. Animal metabolism. 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 on 
equivalent excretion half-lives (4 hours), pattern of excretion greater 
than 90% in urine or urinary metabolite identification greater than 80% 
as free acid. 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%.
    7. Metabolite toxicology. There are no metabolites of toxicological 
significance to mammals.
    8. Endocrine disruption. No special studies investigating potential 
estrogenic or endocrine effects of bentazon have been conducted. 
However, the standard battery of required studies has been completed. 
These studies include an evaluation of the potential effects on 
reproduction and development, and an evaluation of the pathology 
exposure. These studies are generally considered to be sufficient to 
detect any endocrine effects but no such effects of the endocrine 
organs following repeated or long-term were noted in any of the 
studies.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. In 1999, EPA evaluated the hazard and 
exposure data for bentazon and recommended that the FQPA safety factor 
be retained at 10X in assessing the risk posed by this chemical because 
there was evidence of increased susceptibility in the developmental 
toxicity study in rats and in the 2-generation reproduction toxicity 
study in rats. The 10X FQPA Safety Factor is applicable to females 13-
50 years old for acute dietary and residential exposure assessments and 
to all population subgroups for chronic dietary and residential 
exposure assessments. The acute and chronic Population Adjusted Doses 
(aPAD and cPAD, respectively) are modification of the acute and chronic 
Reference Doses (RfDs) to include the FQPA safety factor. The acute or 
chronic PAD is equal to the acute or chronic RfD divided by the FQPA 
safety factor.
    Acute and chronic dietary exposure analyses for bentazon were 
performed using the Dietary Exposure Evaluation Model (DEEM) which 
incorporates data generated in the USDA 1989-1992 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). For the acute analysis, 
tolerance level residues were used and 100% crop treated (CT) was 
assumed for all commodities (Tier I) for the females 13-50 years old 
subgroup (the subpopulation of concern). For all the females 13-50 
years old subgroup, 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.
    A refined chronic dietary exposure analysis (Tier 3) was performed 
using anticipated and tolerance level residues for 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 residues in food associated with the 
existing and proposed uses of bentazon do not exceed EPA's level of 
concern.
    ii. Drinking water. SCI-GROW (Screening Concentration in Ground 
Water) modeling indicates that bentazon residue (bentazon + its 
metabolite, 2-amino-N-isopropyl benzamide (AIBA) concentrations in 
ground water used as drinking water are not likely to exceed 4.25 parts 
per billion (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 ground water 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

[[Page 55663]]

and ground water estimates were used to compare against back-calculated 
drinking water levels of comparison (DWLOCs) for aggregate risk 
assessments. For the acute exposure scenario, the DWLOC is 2800 ppb for 
females (13+/nursing). For the chronic exposure scenario, the DWLOCs 
are 95, 82, 22, 94, and 95 ppb for the U.S. population, females (13+/
nursing), children (1-6 years), Hispanics and males (13-19 years), 
respectively.
    2. 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.
     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 it was 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 1 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, the proposed assumptions are used 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 screening-level assumptions, it is believed 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.

D. Cumulative Effects

    There is no 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 
notice of filing, therefore, it is assumed that bentazon does not have 
a common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. 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, it was 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.
     Chronic (non-cancer) aggregate risk estimates are below EPA's 
level of concern. The chronic dietary exposure analysis for residues in 
food incorporated anticipated and tolerance level residues for 
commodities. Percent crop treated 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.
     Aggregate short-term risk estimates are below EPA's level of 
concern. In aggregating short-term risk, the background chronic dietary 
exposure (food + drinking water) and short-term inhalation exposures 
from residential uses are considered. 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 contribution to short-term aggregate 
exposure.

[[Page 55664]]

     Aggregate intermediate-term risk estimates are below EPA's level 
of concern for adults. In aggregating intermediate-term risk, the 
background chronic dietary exposure (food + drinking water) and 
intermediate-term dermal exposures from residential uses are 
considered. 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.
     A cancer risk assessment was not done. Bentazon is classified as a 
Group E chemical (evidence of non-carcinogenicity for humans) based 
upon lack of evidence of carcinogenicity in rats and mice. Based on 
these risk assessments, it is concluded that there is a reasonable 
certainty that no harm will result from aggregate exposure to bentazon 
residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of bentazon, data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat are considered. 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.
     The toxicological data base for evaluating prenatal and postnatal 
toxicity of bentazon is complete with respect to current data 
requirements. There was evidence of increased susceptibility following 
in utero exposure to bentazon in the prenatal developmental toxicity 
study in rats and there was quantitative evidence of increased 
susceptibility following prenatal/postnatal exposure to bentazon in the 
2-generation reproduction study in rats.
     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 prenatal/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). An acute endpoint was not 
identified and this risk assessment was not required.
     Using the exposure assumptions described in this unit, it was 
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, the aggregate 
exposure is not expected to exceed 100% of the chronic PAD.
     Although bentazon is 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, background 
chronic dietary exposure (food + drinking water) and intermediate-term, 
non-dietary oral and dermal exposures from residential uses are 
considered. 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.
     Based on these risk assessments, BASF concludes that there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to bentazon residues.

F. International Tolerances

     There is neither a Codex proposal, nor Canadian or Mexican limits 
for residues of bentazon in clover. Therefore, a compatibility issue is 
not relevant to the proposed tolerance.

[FR Doc. 01-27600 Filed 11-1-01; 8:45 am]
BILLING CODE 6560-50-S