[Federal Register: February 11, 2005 (Volume 70, Number 28)]
[Notices]
[Page 7260-7264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe05-52]
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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: miller.joanne@epa.gov.
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 opp-docket@epa.gov,
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