[Federal Register Volume 70, Number 28 (Friday, February 11, 2005)]
[Notices]
[Pages 7260-7264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2618]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0018; FRL-7696-9]


Endothall; 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 identification (ID) number OPP-
2005-0018, must be received on or before March 14, 2005.

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: Joanne Miller, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6224; 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 production (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.

[[Page 7261]]

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-2005-0018. 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, 1801 S. Bell St., 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.1. 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 in 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 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-2005-0018. 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-2005-0018. 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-2005-0018.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information

[[Page 7262]]

and Records Integrity Branch (PIRIB), Office of Pesticide Programs 
(OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2005-0018. 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: January 31, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition (PP) is printed 
below as required by section 408(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA). The summary of the petition was prepared by the 
petitioner 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 
pesticide chemical residues or an explanation of why no such method is 
needed.

Cerexagri, Inc.

    PP 9F6015

    EPA has received a pesticide petition (PP 9F6015 ) from Cerexagri, 
Inc., 630 Freedom Business Center, Suite 402, King of Prussia, PA 
19406, proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing a tolerance for 
residues of endothall (7-oxabicyclo [2.2.1] heptane-2,3-dicarboxylic 
acid) in or on the raw agricultural commodity fish/shellfish at 0.25 
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 FFDCA; however, EPA has not fully evaluated the 
sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Analytical method. The analytical method for endothall in water 
is EPA/ORD Method 548, Determination of Endothall in Drinking Water by 
Aqueous Derivatization, Liquid-Solid Extraction and Gas Chromatography 
with Electron-Capture Detection. The Limit of Detection (LOD) for this 
method is 0.015 ppm.
    2. Magnitude of residues. Aquatic species were exposed for 7 days 
under static conditions at the maximum label rate. The highest 
endothall residues were observed in Bluegill at 0.035 ppm. Catfish 
showed no detectable endothall residues (LOQ = 0.020 ppm). The maximum 
residue for crayfish was 0.23 ppm after 5 days exposure. No evidence of 
accumulation was seen in any of the aquatic organisms.

B. Toxicological Profile

    1. Acute toxicity. Endothall acid and the disodium salt of 
endothall are moderately toxic by oral ingestion and inhalation 
(Toxicity Category II), slightly toxic by dermal exposure (Toxicity 
Category III), and severely irritating to the eye. The diamine salt of 
endothall is moderately toxic by oral, dermal, and inhalation routes of 
exposure (Toxicity Category II) and is severely irritating to the eyes 
and skin.
    2. Genotoxicty. A full battery of genetic toxicology studies were 
conducted for endothall. Endothall is not mutagenic.
    3. Reproductive and developmental toxicity. In a teratology and 
postnatal behavioral study, pregnant Sprague-Dawley rats were dosed via 
oral gavage on gestation days 6 through 15 with endothall doses of 0, 
10, 20, and 30 milligrams/kilogram/day (mg/kg/day). The maternal no-
observed-effect-level (NOEL) was 20 mg/kg/day due to mortality seen at 
30 mg/kg/day. The developmental NOEL was 30 mg/kg/day.
    In a subsequent developmental toxicity study, pregnant Sprague-
Dawley rats were orally dosed with 0, 6.25, 12.5, and 25.0 mg/kg/day 
from gestation day 6 through 15. The NOEL for maternal toxicity was 
12.5 mg/kg/day. The developmental NOEL was 25.0 mg/kg/day. A 
developmental toxicity study was conducted in female CD-1 mice. Groups 
of pregnant mice were orally dosed with 0, 5, 20, or 40 mg/kg/day on 
days 6 to 16 of gestation. The NOEL for maternal toxicity was 5 mg/

[[Page 7263]]

kg/day based on mortality seen at 20 mg/kg/day. The developmental NOEL 
was 20 mg/kg/day. Developmental changes seen at 40 mg/kg/day were 
related to the severe maternal toxicity at that dose.
    A developmental toxicity study was conducted on New Zealand white 
rabbits by oral exposure. Preliminary studies indicated that the rabbit 
was extremely sensitive to endothall. Groups of pregnant rabbits were 
dosed with 0, 0.3, 1.0, or 3.0 mg/kg/day on gestation days 6 through 
19. The fetal and maternal toxicity NOELs were 1.0 mg/kg/day.
    A 2-generation reproduction study was conducted in rats. In this 
study, groups of rats received dietary doses of 0, 30, 150, and 900 
ppm. The no-observed-adverse-effect-level (NOAEL) for parental effects 
was <30 ppm (2-2.3 mg/kg/day) based on proliferative lesions of the 
gastric epithelium seen in male and female animals. The NOAEL for 
offspring toxicity was 150 ppm (9.4 mg/kg/day) based on decreased pup 
body weights on day 0 for the F1a and F2a generations at the 900 ppm 
(60 mg/kg/day) dietary level.
    4. Subchronic toxicity. Male and female Sprague-Dawley rats were 
exposed dermally to 0, 30, 100, and 300 mg/kg/day for 21 days. The 
lowest-observed-effect-level (LOEL) was 30 mg/kg/day based on decreased 
body weight gain and dermal irritation. A NOEL was not established.
    Male and female Sprague-Dawley rats were exposed to oral 
concentrations of 0, 150, 600, or 1,800 ppm (0, 10, 39, or 118 for 
males; 0, 12, 51, or 153 mg/kg/day for females, respectively) for 13 
weeks. The LOEL was 1,800 ppm based on decreases in body weight gain 
and food intake. The NOEL was 600 ppm.
    Male and female beagle dogs were exposed to oral concentrations of 
0, 100, 400, or 1,000 ppm (0, 3.2, 11.7, or 27.5 mg/kg/day for males 
and 0, 3.2, 13.0, or 28.9 mg/kg/day for females, respectively) for 13 
weeks. The LOEL was 1,000 ppm based on decreases in body weight gain 
and food intake. The NOEL was 400 ppm.
    5. Chronic toxicity. In a combined chronic toxicity and 
oncogenicity study, male and female Sprague-Dawley rats were fed 
endothall dietary concentrations of 0, 150, 300, 900, and 1,800 ppm for 
104 weeks. The NOAEL was 300 ppm (12 mg/kg/day) for males based on 
lower body weight gain and histologic changes in the nonglandular 
stomach seen in the 900 ppm (37 mg/kg/day) males. The NOAEL was 150 ppm 
(8.7 mg/kg/day) for females based on dose-related body weight 
decrements in the females receiving 300 ppm (16 mg/kg/day). No evidence 
of carcinogenicity was seen in this study.
    Beagle dogs were fed diets containing 0, 100, 300, or 800 ppm 
disodium endothall (equivalent to 0, 2, 6, or 16 mg/kg/day endothall) 
for 24 months. No clinical signs of toxicity were seen at any dose 
level. The 100 ppm dietary concentration (2 mg/kg/day) was the NOAEL.
    In a 52-week oral toxicity study, groups of 4 male and 4 female 
beagle dogs were fed diets containing 0, 150, 450, or 1,350/1,000 ppm 
(0, 5.7, 17.1, or 35.8 mg/kg/day for males; 0, 6.4, 18.8, or 36 mg/kg/
day for females). The 1,350 ppm dietary level had to be reduced to 
1,000 ppm after 6 weeks of treatment due to marked reductions in body 
weight and food consumption and subsequent sacrifice of 5 animals from 
this group. Minimal to very mild gastric epithelial effects were seen 
in some of the dogs receiving 150 ppm. This effect was considered as a 
low grade reaction to the chronic epithelial irritation and 150 ppm is 
considered the NOAEL. In an 18-month oncogenicity study, Swiss Albino 
mice were fed in the diet at concentrations of 0, 50, 100, or 300 ppm 
(0, 8.1, 16.7, or 50 mg/kg/day for males; 0, 10.8, 22.4, or 68 mg/kg/
day for females) for 92 weeks. The systemic NOEL was 100 ppm based on 
decreased mean body weight in 300 ppm males. No evidence of 
carcinogenicity was seen in this study.
    In a second 18-month dietary oncogenicity study, groups of 50 male 
and 50 female Swiss Albino mice were fed the disodium salt of endothall 
at dietary concentrations of 0, 750, or 1,500 ppm (0, 122, or 258 mg/
kg/day for males; 0, 152, or 319 mg/kg/day for females). Toxicity 
results for the 1,500 ppm dietary level clearly shows that the maximum 
tolerated dose (MTD) was exceeded. At 750 ppm, compound-related effects 
consisted of decreased boy weight gain, rectal prolapse, and an 
increase in the incidence and severity of mucosal hyperplasia of the 
glandular stomach. Endothall was not considered carcinogenic in this 
study.
    6. Animal metabolism. Following a single oral administration of 
14C-endothall to male and female rats, the majority of the 
radioactivity was excreted within 24 hours. The majority of the 
radioactivity was found in the feces. Chromatographic analysis of 
extracts of the urine, feces, cecum, and large intestine of both male 
and female rats gave a single radioactive component corresponding to 
unchanged endothall.
    7. Endocrine disruption. Evaluation of the results from the 2-
generation reproduction studies do not demonstrate any effects 
suggestive of disruption of hormonal stasis in the rat. Further, 
histophathologic evaluation of hormone-sensitive tissues from 
chronically exposed rats, mice, and dogs did not reveal any changes 
suggestive of an endocrine related effect.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Endothall exposure via the diet will 
occur from treated potatoes and cotton. Secondary residues are expected 
in meat, milk, and eggs as well as shellfish, fish, catfish, and 
crayfish
    ii. Drinking water. Drinking water exposure to endothall may be 
expected. However, this exposure is not considered to be significant 
due to intermittent seasonal use of the product for aquatic weed 
control, its low mobility in surface waters and rapid degradation.
    2. Non-dietary exposure. There are no registered or proposed uses 
for endothall products which would result in non-occupational exposure.

D. Cumulative Effects

    Cerexagri, Inc. has reviewed chemical structure data to determine 
if any other pesticide products are chemically similar to endothall and 
produce gastrointestinal changes specific to endothall. Endothall 
appears to be chemically and toxicologically dissimilar to existing 
chemical substances. Therefore, cumulative risk should not be an issue 
for this chemical.

E. Safety Determination

    1. U.S. population. The acute Population Adjusted Dose (aPAD) used 
in the assessment is 0.05 mg/kg/day and was derived using the NOAEL for 
maternal toxicity in a developmental study with the mouse (5 mg/kg/day) 
with a 100X uncertainty factor (10X for intraspecies and 10X for 
interspecies variation). The chronic Population Adjusted Dose (cPAD) is 
0.007 mg/kg/day. The cPAD was derived using the LOAEL of 2 mg/kg/day 
from a 2-generation reproduction study. An uncertainty factor of 300X 
(10X for intraspecies variation, 10X for interspecies variation, 3X for 
extrapolation of a LOAEL to a NOAEL.
    i. Acute exposure and risk. The group with the highest exposure 
levels were 6 year olds in the winter with exposure levels of 0.011896 
mg/kg/day (23.8% of the aPAD). The maximum seasonal average observed 
for adults was 0.010637 mg/kg/day (21.3% of the aPAD) for 46 year olds 
in the fall. The maximum seasonal average was less than 0.005 mg/kg/day 
(10% of the aPAD) for most of the population (1,000 people).

[[Page 7264]]

    A separate analysis was conducted for women of childbearing age 
(13-50 years) with a population of 500 people. The maximum observed was 
0.005087 mg/kg/day (10% of the aPAD) for 41 year olds in the spring. 
However, exposure was less than 0.0002 mg/kg/day (0.4% of the aPAD) for 
most ages and seasons.
    When acute exposure to endothall in water is aggregated with 
maximum acute exposure to food, the estimated total exposure to 
children is 0.0319 mg/kg/day, representing 64% of the aPAD. The maximum 
estimated total exposure to endothall in food and water for adults is 
0.0163 mg/kg/day, representing 33% of the aPAD.
    ii. Chronic exposure and risk. The group with the highest exposure 
levels was 2 year olds in the winter with exposure levels of 0.000071 
mg/kg/day (1% of the cPAD). The highest seasonal average observed for 
adults was 0.000055 mg/kg/day (0.8% of the aPAD) for 78 year olds in 
the summer. Exposure to the U.S. population (based on a population of 
1,000 people) was 0.000039 mg/kg/day, representing 0.6% of the cPAD).
    When chronic exposure to endothall in water is aggregated with 
maximum chronic exposure to food, estimated total exposure to children 
is 0.000451 mg/kg/day, representing 6.4% of the cPAD. The maximum 
estimated total exposure to endothall in food and water for adults is 
0.000165 mg/kg/day, representing 2.4% of the cPAD.
    2. Infants and children. The exposure to infants and children has 
been calculated in both the acute and chronic dietary assessments. In 
all cases and all age groups of infants and children, the margins of 
exposure are sufficient to protect the health of infants and children.

F. International Tolerances

    No international tolerances have been set for endothall.

[FR Doc. 05-2618 Filed 2-10-05; 8:45 am]
BILLING CODE 6560-50-S