[Federal Register Volume 69, Number 44 (Friday, March 5, 2004)]
[Notices]
[Pages 10443-10447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E4-463]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0004; FRL-7342-5]


Endosulfan; 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 ID number OPP-2004-0004, must be 
received on or before April 5, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Dana Pilitt, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7071; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop protection (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0004. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This 
docket facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The docket telephone number is (703) 
305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although, not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although, not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
providing electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on

[[Page 10444]]

the first page of your comment. Please ensure that your comments are 
submitted within the specified comment period. Comments received after 
the close of the comment period will be marked ``late.'' EPA is not 
required to consider these late comments. If you wish to submit CBI or 
information that is otherwise protected by statute, please follow the 
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit 
CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0004. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0004. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0004.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2004-0004. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed 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 
ID 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 FFDCA 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: February 17, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by Endosulfan Task Force and represents the view of the 
petitioner. The petition summary announces the availability of a 
description of the analytical methods available to EPA for the 
detection and measurement of the

[[Page 10445]]

pesticide chemical residues or an explanation of why no such method is 
needed.

Endosulfan Task Force

PP 3E6757

    EPA has received pesticide petition (PP 3E6757) from the Endosulfan 
Task Force, c/o Dr. Bert Volger, Ceres International LLC, 1087 
Heartsease Drive, West Chester, PA 19382 proposing, pursuant to section 
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), to amend 40 CFR part 180, by establishing a tolerance for the 
total residues of endosulfan (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-
hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-oxide expressed as the 
sum of [alpha]- and [beta]-endosulfan), and its metabolite, endosulfan-
sulfate (6,7,8,9,10,10-hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-
2,4,3-benzodioxathiepin-3-dioxide) in or on the raw agricultural 
commodity, imported green coffee beans, at 0.2 parts per million (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.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of endosulfan in plants and 
animals is adequately understood for the purpose of the proposed 
tolerance. Acceptable metabolism studies depicting the qualitative 
nature of the residues in apple, cucumber, and lettuce have 
demonstrated that the residues of concern are [alpha]- and [beta]-
endosulfan, and endosulfan sulfate.
    2. Analytical method. Adequate analytical methodology using gas 
liquid chromatography/electron capture (GLC/EC) detection is available 
for enforcement purposes. The Pesticide Analytical Manual (PAM) Vol.II 
lists Methods I, II and III for determination of endosulfan and/or its 
sulfate metabolite. The limit of detection was validated for each 
endosulfan isomer and its sulfate metabolite at 0.01 ppm for green 
coffee beans and its processed fractions, roasted beans and instant 
coffee.
    3. Magnitude of residues. A total of 10 field trials were conducted 
in the major coffee producing countries of Brazil (3), Colombia (3), 
Guatemala (2), and Mexico (2) to evaluate the quantity of endosulfan 
residues in or on dried green coffee beans following application of 700 
grams endosulfan per hectare, 3 times during growing season with the 
last application 30 days before harvest. The highest total endosulfan 
residues were measured in one dried green bean sample at 0.11 ppm. In 
addition, there were two trials conducted at a single 3X exaggerated 
rate (2,100 g/ha) for processing purposes. There were no detectable 
residues < 0.01 ppm of [alpha]-endosulfan, [beta]-endosulfan and 
endosulfan sulfate in ground roasted beans or instant coffee. 
Therefore, the data support the requested tolerance.

B. Toxicological Profile

    1. Acute toxicity. Endosulfan is highly toxic following acute oral 
exposure and moderately toxic following acute inhalation exposure. In 
rats, oral median lethal doses (LD50 values) are 82 
milligrams/kilogram (mg/kg) (males) and 30 mg/kg (females). Medium 
lethal concentrations (LC50 values) in rats following acute 
inhalation exposure range from 0.16 to 0.5 milligram liter (mg/L). 
Endosulfan is considerably less lethal, however, following acute dermal 
exposure (LD50 is 2 grams/kilogram (g/kg). Endosulfan is an 
eye irritant in rabbits (Toxicity Category I) but is not a dermal 
irritant or sensitizer.
    2. Genotoxicty. Endosulfan does not show any mutagenic potential. 
The submitted mutagenicity studies have satisfied the data requirements 
for mutagenicity testing, and there is no concern for a mutagenic 
effect in somatic cells. In the in vitro or in vivo mutagenicity 
studies, both the mouse lymphoma forward mutation assay and the 
unscheduled DNA synthesis assay were negative.
    3. Reproductive and developmental toxicity. A developmental 
toxicity study in rats indicated a maternal no observed adverse effect 
level (NOAEL) of 2.0 mg/kg body weight/day (bwt/day) based on increased 
mortality, tonoclonic convulsions, increased salivation and decreased 
body weight gains and food consumption at 6.0 mg/kg bwt/day. The 
developmental NOAEL was 2.0 mg/kg bwt/day, based on a slight increase 
in skeletal variations and occurrence of fetuses/litter weighing less 
than 3 grams at the maternally toxic dose of 6.0 mg/kg bwt/day. An oral 
developmental toxicity study in rabbits showed a maternal NOAEL of 0.7 
mg/kg bwt/day and a maternal lowest observed adverse effect level 
(LOAEL) of 1.8 mg/kg bwt/day, based on decreased body weight, increased 
mortality, convulsions, rapid breathing, salivation and hyperactivity 
during the dosing period. A fetal NOAEL of greater than 1.8 mg/kg bwt/
day was also observed in this study. A two-generation reproduction 
study in rats indicated parental and offspring NOAELs of 1.2 mg/kg bwt/
day, based on reductions in body weight in adults and increased 
pituitary weights in the female pups of the F0 generation and increased 
uterine weights in the F1b generation at 6.2 mg/kg bwt/day.
    4. Subchronic toxicity. In a 13-week feeding study in rats, 
endosulfan demonstrated a NOAEL of 0.5 mg/kg bwt/day, based on kidney 
abnormalities and increased spleen weights in male rats at 1.5 mg/kg 
bwt/day. In a 13-week feeding study in mice the resulting NOAEL was 2.1 
mg/kg bwt/day, based on increased mortality in males and females seen 
at 7.3 mg/kg bwt/day. A 6-month toxicity feeding study in dogs 
established a NOAEL of 5 mg/kg bwt/day. The LOAEL was 15 mg/kg bwt/day 
based on clinical signs of neurotoxicity and gastrointestinal 
disturbances.
    Two subchronic dermal studies were conducted with endosulfan. In 
the first study endosulfan was applied dermally 5 days a week over 30 
days. The resulting NOAELs were established at 12 mg/kg/day in females 
and 96 mg/kg/day in males. The LOAELs were determined to be 48 mg/kg/
day in females and 192 mg/kg/day in males based on increased mortality 
in males and females and increased serum cholinesterase inhibitor (ChE) 
activity inhibition in males. In the second study endosulfan was 
administered dermally 5 days a week over 30 days. The LOAELs were 
determined to be 81 mg/kg/day in males and 27 mg/kg/day in females 
based on increased mortality. The NOAELs were established at 27 mg/kg/
day in males and 9 mg/kg/day in females. The dose and endpoint selected 
for risk assessment was dermal NOAEL = 12 mg/kg/day based on mortality 
in female rats at 27 mg/kg/day LOAEL. The endpoints from both 21-day 
dermal toxicity studies discussed above were considered in arriving at 
the NOAEL and LOAEL. In a subchronic inhalation study conducted with 
endosulfan, rats were exposed 6 hours per day, 5 days per week for a 
total of 21 exposures over 29 days. The NOAEL was 0.001 mg/L (0.2 mg/kg 
bwt/day), based on decreased body weight gain and leukocyte counts in 
the males and increased creatinine values in the females at 0.002 mg/L 
(0.4 mg/kg bwt/day).
    5. Neurotoxicity. In an acute neurotoxicity study with endosulfan 
the resulting NOAEL was 12.5 mg/kg for males and 1.5 mg/kg for females. 
The LOAEL was 25 mg/kg for males based on increased incidences of 
stilted gait, squatting posture, and irregular respiration, as well as 
decreased spontaneous activity. The LOAEL was 3

[[Page 10446]]

mg/kg for females, based on an increased incidence of stilted gait, 
squatting posture, straddled hindlimbs, irregular respirations, panting 
and bristled coat and decreased spontaneous activity.
    6. Chronic toxicity. A 12-month chronic feeding study in dogs 
established a NOAEL of 0.65 and 0.57 mg/kg bwt/day in males and 
females, respectively. The LOAEL for this study was established at 1.75 
mg/kg bwt/day, based on decreased body weight gain in males and 
increased incidences of neurological findings in males and females. A 
24-month chronic feeding/carcinogenicity study in rats demonstrated a 
NOAEL of 0.6 mg/kg bwt/day and an average LOAEL of 3.4 mg/kg bwt/day, 
based on decreased body weight gains and increased incidences of marked 
progressive glomerulonephrosis in males and females, enlarged kidneys 
in females and blood vessel aneurysms in males. A 24-month 
carcinogenicity study in mice was conducted. The NOAEL was 0.9 mg/kg/
bwt/day, based on increased incidences of mortality in females at 2.65 
mg/kg. Under the conditions of these studies, there was no evidence of 
carcinogenic potential.
    7. Animal metabolism. Following absorption from the oral or dermal 
exposure routes endosulfan is partially metabolized, primarily to 
endosulfan sulfate. Minor metabolites include endosulfan diol, 
endosulfan ether, endosulfan [alpha]-hydroxy ether, and endosulfan 
lactone. None of the minor metabolites of endosulfan are believed to be 
of toxicological concern. Endosulfan and its metabolites partition and 
accumulate predominately in the kidney and liver. Following dietary 
exposure to endosulfan, a large amount of endosulfan sulfate is 
recovered in the liver, small intestine and visceral fat, and only a 
trace amount is recovered in muscle tissue. Endosulfan and its 
metabolites are excreted in both the urine and feces, the latter being 
the predominant route of excretion. Most of an absorbed dose of 
endosulfan is excreted within a few days to a few weeks, depending upon 
dose and route of exposure.
    8. Metabolite toxicology. The major metabolite of concern for 
endosulfan is endosulfan sulfate. This metabolite is assumed to have 
equal toxicity to the parent.
    9. Endocrine disruption. There is no evidence of endocrine effects 
in any of the studies conducted with endosulfan, thus, there is no 
indication at this time that endosulfan causes endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. Permanent tolerances have been established for 
the total residues of the insecticide endosulfan (6,7,8,9,10,10-
hexachloro-1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-
3-oxide, expressed as the sum of [alpha]- and [beta]-endosulfan), and 
its metabolite, endosulfan-sulfate (6,7,8,9,10,10-hexachloro-
1,5,5a,6,9,9a-hexahydro-6,9-methano-2,4,3-benzodioxathiepin-3-dioxide) 
in or on a variety of raw agricultural and livestock commodities (40 
CFR 180.182). The chronic assessment is based on a chronic population 
adjusted dose (cPAD) of 0.0006 mg/kg bwt/day. The acute assessment is 
based on an acute PAD of 0.0015 mg/kg bwt/day for all population 
subgroups.
    i. Food. Chronic and acute dietary exposure estimates resulting 
from the proposed import tolerance and all currently registered uses of 
endosulfan, except the pending deletions of succulent beans, succulent 
peas, grapes, spinach, and pecans are well within acceptable limits for 
all sectors of the population. Potential dietary exposures from food 
were estimated using the Dietary Exposure Evaluation Model 
(DEEMTM) software system (Exponent, Inc.) and the 1989-1992 
USDA consumption data. For the chronic analysis, mean residue values 
were calculated from the appropriate field trials or monitoring studies 
conducted for endosulfan, which were reviewed in EPA's most recent 
dietary risk assessment (Endosulfan reregistration eligibility 
decisions (RED), November 2002). For the acute analysis, the entire 
distribution of field trial residue or monitoring values were used for 
non-blended and partially blended commodities, and the mean value used 
for blended commodities. Processing factors were obtained from good 
laboratory practice (GLP) processing studies for the appropriate 
commodities. Percent crop treated values were obtained from the RED 
dietary assessment. The dietary risks (acute, chronic) concerning the 
tolerance reassessment indicate the following: for the chronic analysis 
the most highly exposed sub-population was children 1-2 years old 
utilizing 19.5% of the cPAD or 0.000117 mg/kg bwt/day. The U.S. 
population utilized 6.4% of the cPAD or 0.000038 mg/kg bwt/day. For the 
acute analysis the most highly exposed sub-population was again 
children 1-2 years old at 84.9% of the aPAD or 0.001274 mg/kg bwt/day, 
and the U.S. population at 52.6% of the aPAD or 0.000790 mg/kg bwt/day. 
Actual exposures are likely to be much less because of the conservative 
assumptions incorporated in this analysis. The calculated residue 
contribution from imported coffee is negligible.
    ii. Drinking water. Since the proposed tolerance is for imported 
coffee beans, there is no potential exposure from drinking water.
    2. Non-dietary exposure. Endosulfan is currently not registered for 
use on any sites that would result in residential exposure.

D. Cumulative Effects

    To our knowledge there are currently no available data or other 
reliable information indicating that any toxic effects produced by 
endosulfan would be cumulative with those of other pesticides; thus 
only the potential risks of endosulfan have been considered in this 
assessment of its aggregate exposure. Once the final framework for 
cumulative risk assessments is available, the Agency might identify 
other substances that share a common mechanism of toxicity with 
endosulfan.

E. Safety Determination

    1. U.S. population. Using the assumptions and data described above 
and based on the completeness and reliability of the toxicity data, it 
can be concluded that the residue contribution of the proposed import 
tolerance is negligible. The chronic dietary exposure will utilize at 
most 6.4% of the cPAD, and 52.6% of the aPAD for the U.S. population. 
The actual exposure, both acute and chronic, is likely to be much less 
as more realistic data and models are developed. EPA generally has no 
concern for exposures below 100% of the PAD because the PAD represents 
the level at or below which daily aggregate exposure over a lifetime 
will not pose appreciable risk to human health. The Endosulfan Task 
Force concludes, there is reasonable certainty that no harm will occur 
to the U.S. population from acute or chronic aggregate exposure (food 
and drinking water) to residues of endosulfan in view of the proposed 
tolerance for imported coffee beans.
    2. Infants and children. The EPA HIARC has chosen to retain the 10X 
Food Quality Protection Act (FQPA) Safety factor for endosulfan. Using 
the assumptions and data described in the exposure section above, the 
percent of the cPAD that will be used for exposure to residues of 
endosulfan in food for children 1-2 yrs (the most highly exposed sub-
population) is 19.4%. Infants utilize 8.9% of the cPAD. For the acute 
assessment children 1-2 yrs utilize 84.9% of the aPAD and infants 
utilize 71.7% of the aPAD. The

[[Page 10447]]

proposed import tolerance will have minimal impact on the dietary risk. 
Therefore, there is a reasonable certainty that no harm will occur to 
infants and children from aggregate exposure (food and drinking water) 
to residues of endosulfan from imported coffee beans.

F. International Tolerances

    A codex maximum residue level MRL of 0.1 ppm has been established 
for residues of endosulfan in or on coffee beans.

[FR Doc. E4-463 Filed 3-4-04; 8:45 am]
BILLING CODE 6560-50-S