[Federal Register Volume 66, Number 220 (Wednesday, November 14, 2001)]
[Notices]
[Pages 57082-57086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28198]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1052; FRL-6808-9]


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-1052, must be 
received on or before December 14, 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-1052 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt Jamerson, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9368; 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 codes         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

[[Page 57083]]

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up 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-1052. 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-1052 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-1052. 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, 
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 30, 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 views of the 
petitioner. 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.

[[Page 57084]]

Interregional Research Project Number 4 (IR-4)

9E5037, and 1E6326, and 1E6345

    EPA has received three pesticide petitions (9E5037 (canola), 1E6326 
(dill), and 1E6345 (safflower)) from 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 FFDCA, 21 U.S.C. 346a(d), 
to amend 40 CFR part 180 by establishing tolerances for residues of 
ethalfluralin in or on the raw agricultural commodities (RACs) canola, 
safflower and dill at 0.05 parts per million (ppm).
    EPA has determined that this petition contain 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.

A. Residue Chemistry

    1. Plant metabolism. Nature of residue studies with 14C 
ethalfluralin have demonstrated very low terminal residues and that 
ethalfluralin per se is the residue of concern in plants grown in soil 
treated with this compound and that there are no significant metabolic 
products. These studies indicate that it is appropriate to base a 
tolerance on residues of the parent compound, ethalfluralin.
    2. Analytical method. A residue method has been developed and 
validated at a limit of quantitation (LOQ) of 0.02 g/g for the 
determination of ethalfluralin in canola seed which utilizes capillary 
gas chromatography with mass selective detection (GC)/MSD. Validation 
data were generated using this method during the analysis of the canola 
seed field samples from the magnitude of residue studies.
    For safflower, adequate residue analytical methods are available 
for purposes of registration based upon the analytical method for 
sunflower. A GC method, Method I, with electron capture detection is 
listed in the Pesticide Analytical Manual ((PAM), Vol. II, Section 
180.416), for tolerance enforcement. Method I is applicable for 
analysis of ethalfluralin residues in/on sunflower seed. The limit of 
detection is 0.01 ppm.
    Dill was analyzed by the method ``Determination of Ethalfluralin in 
Agricultural Crops and Soil.'' Residue method number AM-AA-CA-R025-AB-
755, Lilly Research Laboratories, Greenfield, IN (Currently Dow 
AgroSciences). The LOQ was 0.050 ppm by a GC with a Ni63 
electron capture detector. Method validation was performed both prior 
to and concurrently with sample analysis.
    3. Magnitude of residues. In the magnitude of residue field 
studies, herbicides containing the active ingredient ethalfluralin [N-
ethyl-N-(2-methyl-2-propenyl)-2,6-dinitro-4-(trifluoromethyl) 
benzenamine] were applied in 1996 at eight sites as a preplant 
incorporated application. Sonalan l0G herbicide was applied directly to 
the soil surface and Sonalan HFP herbicide was diluted in water and 
applied in a spray volume of 16-23 gallons/acre. The applications were 
made to field plots of canola at the rate of 1.25 lb active ingredient/
acre at all sites except Georgia and Washington, and at the rate of 
0.75 lb active ingredient/acre (Georgia and Washington). Three to five 
days after application a second incorporation was done and canola seeds 
were planted. Samples of canola seed were collected at normal harvest, 
87-216 days after the last application. Residues in canola seed 
collected at normal harvest were non-detectable based on a method lower 
limit of detection of 0.004 ppm.
    For safflower, the magnitude of residue data from sunflower are 
surrogate data for safflower. The registered uses of ethalfluralin on 
sunflowers along with the established tolerances on these commodities 
are supported by acceptable field residue data from trials reflecting 
the maximum registered use patterns. In all cases, the residues were 
<0.01ppm. The reregistration requirements for processing studies were 
fulfilled. Adequate processing studies have been conducted on sunflower 
seed. Field residue data resulting from up to 5X label rates showed 
non-detectable (<0.01ppm) residues of ethalfluralin in sunflower seed.
    In dill the magnitude of residue field studies, herbicides 
containing the active ingredient ethalfluralin [N-ethyl-N-(2-methyl-2-
propenyl)-2,6-dinitro-4-(trifluoromethyl) benzenamine] were applied in 
1997 at three sites. Ethalfluralin formulated as Curbit EC was applied 
directly to the soil surface diluted in water and applied in a spray 
volume of 36 gallons/acre. The applications were made to field plots of 
canola at the rate of 1.5 lb active ingredient/acre and incorporated by 
sprinkler irrigation. Samples of dill were collected at normal harvest, 
91-100 days after the last application. Residues in fresh and dried 
dill collected at normal harvest were non-detectable based on a method 
lower limit of detection of 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity. Ethalfluralin is of relatively low toxicity. The 
rat oral LD50 is >10,000 milligrams/kilograms (mg/kg). The 
acute dermal LD50 in rabbits is >2,000 mg/kg and the acute 
rat inhalation LC50 is >0.94 milligrams/Liter (mg/L) air. 
Ethalfluralin produced slight eye irritation and slight dermal 
irritation in rabbits. A guinea pig dermal sensitization study 
conducted by the modified Buehler method found no sensitization, 
whereas a study conducted by the Magnusson and Kligman maximization 
method showed a positive sensitization reaction. The signal word for 
the technical grade active ingredient is Caution.
    2. Genotoxicty. Ethalfluralin was weakly mutagenic in activated 
strains TA1535 and TA100 of Salmonella typhimurium,but not in strains 
TA1537, TA1538, and TA98 in an Ames assay. In a modified Ames assay 
with Salmonella typhimurium and Escherichia coli, ethalfluralin was 
weakly mutagenic in strains TA1535 and TA100, with and without 
activation, and in strain TA98 without activation, at the highest dose. 
No mutagenicity was found in the mouse lymphoma assay for forward 
mutation. Ethalfluralin did not induce unscheduled DNA synthesis in rat 
hepatocytes. In chinese hamster ovary cells, ethalfluralin was negative 
without S9 activation, but it was clastogenic with activation.
    3. Reproductive and developmental toxicity. The maternal no 
observed adverse effect level (NOAEL) of ethalfluralin in rats was 50 
mg/kg/day. The maternal lowest observed adverse effect level (LOAEL) 
was 250 mg/kg/day, based on decreased body weight (bwt) gain and dark 
urine. In this rat study there was no observable developmental 
toxicity. The developmental NOAEL in rats was 1,000 mg/kg/day, the 
highest dose. In rabbits the NOAELs for maternal and developmental 
toxicity were 75 mg/kg/day. The maternal LOAEL at 150 mg/kg/day was 
based on abortions and decreased food consumption. These effects as 
well as decreased weight gain, enlarged liver, and orange urine were 
found at 300 mg/kg/day. In this study developmental toxicity was 
observed. The developmental LOAEL in rabbits was 150 mg/kg/day, based 
on slightly increased resorptions, abnormal cranial development, and 
increased sternal variants. In a three-generation rat reproduction 
study, the parental NOAEL was 12.5 mg/kg/day. The parental LOAEL was 
37.5 mg/kg/day, based on depressed mean body weight gains in males in 
all generations. No

[[Page 57085]]

treatment-related effects were noted on reproductive parameters and the 
NOAEL was 37.5 mg/kg/day or greater. A 7-month multigeneration bridging 
study was conducted with doses equivalent to 0, 8, 20, or 61 mg/kg/day 
in the diet of Fischer 344 rats. The parental NOAEL was 20 mg/kg/day. 
The parental LOAEL was 61 mg/kg/day, based on increased liver weights. 
No treatment-related effects were noted on reproductive parameters and 
the reproductive NOAEL was equal to or greater than 61 mg/kg/day.
    4. Subchronic toxicity. Ethalfluralin was evaluated in five 
subchronic dietary studies which showed NOAELs of 560 ppm in a 3-month 
mouse study, 12 mg/kg/day in a 1-year mouse study, 29 mg/kg/day in a 3-
month rat study, 3.9 mg/kg/day in male rats and 4.9 mg/kg/day in female 
rats in a 1-year study, and 27.5 mg/kg/day in a 3-month dog study. A 
21-day dermal study in rabbits showed no systemic toxicity, while 
slight to severe dermal irritation was observed.
    5. Chronic toxicity. Ethalfluralin was administered to Fisher 344 
rats in the diet for 2 years in combined chronic toxicity and 
carcinogenicity replicate studies. The doses were equivalent to 0, 4.2, 
10.7, or 32.3 mg/kg/day. The NOAEL for systemic effects was 32.3 mg/kg/
day. Mammary gland fibroadenomas were found in dosed female rats at 
statistically significant incidences in the mid and high doses. 
Ethalfluralin was administered to B6C3F1 mice in the diet for 2 years 
in combined chronic toxicity and carcinogenicity replicate studies. The 
doses were equivalent to 0, 10.3, 41.9, or 163.3 mg/kg/day. No 
increased incidence of neoplasms was attributed to the treatment. The 
NOAEL was 10.3 mg/kg/day. The mid dose (LOAEL) and high dose showed 
focal hepatocellular hyperplasia in both sexes. There were increased 
relative liver, kidney, and heart weights in females. Some blood 
changes were found also, including decreased hematocrit, hemoglobin, 
and erythrocyte count accompanied by increased mean corpuscular 
hemoglobin concentration in high dose females. Alkaline phosphatase 
values were increased at the high dose in both sexes. Body weight gain 
decreased at the high dose.
    Beagle dogs were given 0, 4, 20, or 80 mg/kg/day orally, by 
capsule, for 1-year. The NOAEL was 4 mg/kg/day. The LOAEL was 20 mg/kg/
day, based on increased urinary bilirubin, variations in erythrocyte 
morphology, increased thrombocyte count, and increased erythroid series 
of the bone marrow. Elevated alkaline phosphatase levels were found at 
the two higher doses and siderosis of the liver at the high dose.
    EPA's Office of Pesticide Program's Carcinogenicity Peer Review 
Committee concluded that ethalfluralin should be classified as Group C, 
a possible human carcinogen, based on increased mammary gland 
fibroadenomas and adenomas/fibroadenomas combined in female rats. The 
tumor incidences were statistically significant at both the mid and 
high dose, and exceeded of the upper range of historical controls. 
Based on a low dose extrapolation, the Q1* of 8.9 x 
10-2 (mg/kg/day)-1 has been calculated.
    6. Animal metabolism. Fischer 344 rats were treated orally with a 
single low dose, a single high dose, or repeated low doses of 
radiolabeled ethalfluralin. Absorption of ethalfluralin was estimated 
at 79-87% of the dose for all dose levels. Ethalfluralin was rapidly 
and extensively metabolized, and 95% of the chemical was excreted in 
urine and feces by 7 days. The major route of elimination for the 
radiolabel was in the feces, 50.9-63.2%, and the levels remaining in 
the tissues after 72 hours were negligible. The major metabolites in 
urine and feces were identified.
    7. Metabolite toxicology. The residue of concern is ethalfluralin 
per se, as specified in 40 CFR 180.416. Thus there is no need to 
address metabolite toxicity.
    8. Endocrine disruption. There is no evidence to suggest that 
ethalfluralin has an effect on any endocrine system.

C. Aggregate Exposure

    1. Dietary exposure. Acute dietary risk assessments are performed 
for a food-use pesticide if a toxicological study has indicated the 
possibility of an acute effect of concern occurring as a result of a 1-
day or single exposure. EPA has previously used a NOAEL of 75 mg/kg/day 
from a rabbit developmental toxicity study as the toxicity endpoint for 
assessing acute dietary risk in females 13-50 years of age. An acute 
reference dose (RfD) of 0.75 mg/kg/day was calculated, based on a NOAEL 
of 75 mg/kg/day and an uncertainty factor (UF) of 100 (10 for 
interspecies extrapolation and 10 for intraspecies variation). EPA has 
previously added a 3X FQPA safety factor, resulting in an acute 
population adjusted dose (aPAD) of 0.25 mg/kg/day. Likewise, in this 
assessment, acute dietary risk to females 13-50 years old was based on 
an aPAD of 0.25 mg/kg/day.
    Chronic dietary exposure to ethalfluralin is possible due to the 
potential presence of ethalfluralin residue in certain foods. Chronic 
dietary risk was evaluated using a chronic RfD of 0.04 mg/kg/day, which 
is based on a NOAEL of 4 mg/kg/day from a chronic dog study along with 
an UF of 100. EPA previously concluded that an FQPA safety factor of 1X 
is appropriate for assessing chronic dietary risk.
    EPA has concluded that ethalfluralin should be classified as group 
C, a possible human carcinogen, based on increased mammary gland 
fibroadenomas and adenomas/fibroadenomas combined in female rats. 
Therefore, a cancer risk assessment was included. Based on a low dose 
extrapolation, the Q1* of 8.9 x 10-2 (mg/kg/
day)-1 has been calculated and was used in this cancer risk 
assessment.
    i. Food. The dietary exposure assessment was based on all 
commodities with tolerances for ethalfluralin established at 40 CFR 
180.416 together with the proposed tolerances of 0.05 ppm each for 
canola, dill, and safflower. The dietary exposure evaluation model, 
which is produced by Novigen Sciences, Inc. and licensed to Dow 
AgroSciences, was used to estimate dietary exposure. This software used 
the food consumption data for the 1989-1991 United States Department of 
Agriculture Continuing Surveys of Food Intake by Individuals (CSFII 
1989-1991).
    a. Acute. An acute dietary risk assessment was conducted with the 
conservative assumptions of 100% crop treated and tolerance level 
residues for all crops. These assumptions result in a very conservative 
estimate of human exposure and risk. Acute dietary risk for females 13+ 
years old was assessed using an aPAD of 0.25 mg/kg/day. Even with 
conservative assumptions used in this analysis, acute dietary exposure 
was estimated to occupy only 0.05% of the aPAD for females 13+ years 
old. Adverse effects are not expected for exposures occupying 100% or 
less of the aPAD. Therefore, acute exposure and risk from food is well 
within acceptable levels.
    b. Chronic. Chronic dietary exposure and risk was estimated with 
the conservative assumptions of 100% crop treated and tolerance level 
residues for all crops. The estimate of potential chronic exposure and 
risk is very conservative and estimated risk would be substantially 
reduced with further refinement to the exposure estimate. Even with the 
conservative assumptions used in this analysis, chronic exposure is 
estimated to occupy only 0.1% of the RfD for the general U.S. 
population. Chronic dietary exposure is estimated to occupy 0.4% of the 
RfD for non-nursing infants, the population subgroup estimated to have 
highest potential exposure. Therefore, chronic exposure

[[Page 57086]]

and risk from food is well within acceptable levels.
    c. Cancer. Cancer risk was estimated based on percent crop treated 
and anticipated residues as provided in EPA's Reregistration 
Eligibility Decision (RED) for ethalfluralin. Exposure to ethalfluralin 
from food is estimated to result in a lifetime cancer risk of 7.11 x 
10-7. Cancer risks of less than 1 x 10-6 are 
generally considered to be negligible.
    ii. Drinking water. There are no established maximum contaminant 
levels for residues of ethalfluralin in drinking water and health 
advisory levels for ethalfluralin have not been established. EPA has 
previously used modeling for a screening level assessment of potential 
ethalfluralin exposure through drinking water. The Agency has used 
EPA's pesticide root zone model/exposure analysis modeling systems and 
screening concentrations in ground water to provide a screening level 
assessment for surface water and ground water, respectively. Based on 
these models, EPA has indicated the estimated environmental 
concentrations (EECs) for acute exposures are estimated to be 2.3 parts 
per billion (ppb) for surface water and 0.02 ppb for ground water. The 
EECs for chronic exposures are estimated to be 0.052 ppb for surface 
water and 0.02 ppb for ground water. Estimated concentrations of a 
pesticide are compared to a drinking water level of comparison (DWLOC) 
as a surrogate estimate of exposure and risk. The DWLOC is the 
concentration of a pesticide in drinking water that would be acceptable 
as an upper limit in light of total aggregate exposure to that 
pesticide.
    a. Acute. As indicated previously, EPA has used surface water and 
ground water EECs of 2.3 ppb and 0.02 ppb, respectively, for comparison 
with the DWLOC in an acute assessment. The DWLOC for acute exposure in 
females 13+ years old was based on an aPAD of 0.25 mg/kg/day and was 
calculated to be 7,500 ppb. Therefore, the acute DWLOC for 
ethalfluralin is over 3,000 fold greater than the EEC for surface water 
or ground water, indicating that potential acute exposure and risk from 
drinking water is well within acceptable levels.
    b. Chronic. As indicated previously, EPA has used surface water and 
ground water EECs of 0.052 ppb and 0.02 ppb, respectively, for 
comparison with the DWLOC in a chronic assessment. The chronic DWLOC 
was calculated based on a chronic RfD of 0.04 mg/kg/day and accounted 
for potential chronic exposure to ethalfluralin through residues in 
food. The chronic DWLOC for the general U.S. population and non-nursing 
infants was calculated to be 1,400 ppb and 400 ppb, respectively. 
Therefore, chronic DWLOCs are substantially greater than estimated 
residue concentration in surface water or ground water over a chronic 
exposure period, indicating that chronic exposure and risk from 
drinking water are well with acceptable levels.
    c. Cancer. The DWLOC for the cancer risk assessment was calculated 
to be 0.12 ppb. Surface water and ground water EECs of 0.052 ppb and 
0.02 ppb, respectively, were used for comparison with the DWLOC. The 
EECs are below the DWLOC, indicating that the cancer risk would 
generally be considered negligible.
    2. Non-dietary exposure. Ethalfluralin is not currently registered 
for use on any residential non-food sites, and thus, it is not expected 
that non-occupational, non-dietary exposures will occur.

D. Cumulative Effects

    EPA at this time has not established methodologies to resolve the 
complex issues concerning common mechanism of toxicity in a meaningful 
way. Although ethalfluralin is a member of the dinitroaniline class of 
herbicides, there is no information available, at this time to 
determine whether ethalfluralin has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. Based on the metabolic profile, ethalfluralin does not 
appear to produce a toxic metabolite produced by other substances. 
Therefore, only aggregate exposure and risk were considered.

E. Safety Determination

    1. U.S. population. Using conservative exposure assumptions 
previously described, chronic dietary exposure to residues of 
ethalfluralin from current and proposed uses was estimated to occupy 
only 0.1% of the RfD for the general U.S. population. EPA generally has 
no concern for exposures below 100% of the RfD since the RfD represents 
the level at or below which daily exposure over a lifetime will not 
pose appreciable risks to human health. Additionally, the chronic DWLOC 
was found to be substantially greater than EECs for ethalfluralin in 
surface water or ground water, indicating risk is well within 
acceptable levels. Cancer risk resulting from potential exposure to 
ethalfluralin through food and drinking water was estimated. Cancer 
risk from potential dietary and drinking water exposure for the general 
U.S. population was found to be within a range that EPA has generally 
considered negligible. Thus, based on the completeness and reliability 
of the toxicity data and the conservative exposure assessment, it is 
concluded that there is a reasonable certainty that no harm will result 
to the general U.S. population from aggregate exposure to ethalfluralin 
residues from current and proposed uses.
    2. Infants and children. Risk for developmental toxicity from acute 
exposure to ethalfluralin was evaluated for females 13+ years old. As 
indicated in the previous discussion, risk from aggregate acute 
exposure to ethalfluralin through food and drinking water is well 
within acceptable levels. It can be concluded that there is a 
reasonable certainty that no harm will result for both females 13+ 
years old, and for the prenatal development of infants, from aggregate 
acute exposure to ethalfluralin.
    Chronic aggregate exposure and risk was evaluated for non-nursing 
infants, the population subgroup predicted to be most highly exposed. 
As indicated previously, risk from aggregate chronic exposure through 
food and drinking water is well within acceptable levels. Thus, based 
on the completeness and reliability of the toxicity data and the 
conservative exposure assessment, it can be concluded with reasonable 
certainty that no harm will result to infants and children from chronic 
aggregate exposure to ethalfluralin based on current and proposed uses.

F. International Tolerances

    There are no Codex, Canadian or Mexican maximum residue limits 
established for ethalfluralin.
[FR Doc. 01-28198 Filed 11-13-01; 8:45 am]
BILLING CODE 6560-50-S