[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]
[Page 47149-47152]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-70]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0207; FRL-7367-7]
Ethylene Glycol; 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-
2004-0207, must be received on or before September 3, 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: Bipin Gandhi, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8380; e-mail address: gandhi.bipin@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.
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-2004-0207. 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
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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 EPA's 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 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-2004-0207. 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-2004-0207. 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-2004-0207.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2004-0207. 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
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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: July 19, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by the petitioner and represents the view of the petitioner.
The summary may have been edited by EPA if the terminology used was
unclear, the summary contained extraneous material, or the summary
unintentionally made the reader conclude that the findings reflected
EPA's position and not the position 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.
Sumitomo Chemical Company
PP 4E6828
EPA has received a pesticide petition (4E6828) from Sumitomo
Chemical Company, Limited, 5-33, Kitahara, 4-Chome, Chuo-Ku, Osaka 541,
Japan, through their United States agent, proposing, pursuant to
section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
ethylene glycol when used as an encapsulating agent for pesticides
being applied post-harvest as residual, and crack and crevice sprays in
and around food and non-food areas of residential and non-residential
structures, including food handling establishments, with no limit. 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
The primary method for determining ethylene glycol in biological
samples is by gas (and high-resolution gas) high performance liquid
chromotography (HPLC), or colorimetric determination. Gas
chromatography (GC) is also employed to determine ethylene glycol
concentrations in environmental samples such as air, water, food,
drugs, or other substances. Methods for determining biomarkers of
exposure to, and effects of, ethylene glycol are available for blood,
tissue, and urine, as well as for the metabolic products (glycolic acid
and oxalic acid) in blood and urine. The 1997 Agency for Toxic
Substances and Disease Registry (ATSDR) report contains details of
extraction and concentration methods for measuring these metabolites in
humans. Methods for determining ethylene glycol in air, water, or
aqueous solutions, foods, as well as foods stored in plastic containers
from which leaching has occurred have been developed. Methods used to
detect ethylene glycol in environmental samples are approved by EPA,
National Institute of Occupational Safety and Health (NIOSH),
Association of Official Analytical Chemists (AOAC) International, and
American Public Health Association (APHA).
B. Toxicological Profile
1. Acute toxicity. ATSDR established an maximum residue level (MRL)
(minimal risk level) of 0.5 parts per million (ppm) based on a no
observed adverse effect level (NOAEL) of 197 ppm for acute inhalation
exposure to ethylene glycol, and an MRL of 2.0 milligrams/kilogram/day
(mg/kg/day) for acute oral exposure. The American Conference of
Governmental Industrial Hygienists (ACGIH) recommends a maximum level
of 50 ppm (125 milligrams/cubic meter (mg/m\3\)).
Dermal exposure to ethylene glycol causes minimum skin irritation
or toxic effect. Eye contact with ethylene oxide may cause irritation.
2. Genotoxicity. Negative results for mutagenicity were obtained in
the following assays: Mouse lymphoma, with and without activation;
chromosomal aberrations and sister chromatid exchange in cultured
chinese hampster ovary (CHO) cells (with and without activation); and
for deoxyribonucleic acid (DNA) damage in rat hepatocytes. In in vivo
genotoxicity studies, results have also been negative.
3. Reproductive and developmental toxicity. Literature on
reproductive effects of ethylene glycol in humans could not be located.
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Pregnant mice and rats fed ethylene glycol in their diet produced
young with statistically significant increases in external and
vertebral malformations, and the percentage of malformed live fetuses
per litter was significantly increased. Decreased pup weights were
observed, particularly in animals receiving higher doses. New Zealand
White rabbits showed no adverse effects in similar tests.
4. Subchronic toxicity. A human study showed that inhalation of 7-
19 ppm for 20-22 hours a day for 4 weeks did not cause adverse
hematological or immune function effects. No studies were located
describing neurological, reproductive, genotoxicity, or developmental
effects in humans by all other routes of exposure. No subchronic dermal
or oral human studies were found. No subchronic inhalation animal
toxicity studies were located, but subchronic dermal and oral studies
for inhalation exposure showed adverse effects similar to chronic
exposure.
5. Chronic toxicity. The oral reference dose (RfD) for ethylene
glycol is 2.0 mg/kg/day with an uncertainty factor (UF) of 100, based
on the NOAEL of 200 mg/kg/day toxic effect in kidneys in rats.The oral
RfD for ethylene glycol is 2.0 mg/kg/day with an UF of 100, based on
the NOAEL of 200 mg/kg/day toxic effect in kidneys in rats. Rats and
mice given ethylene glycol orally for 2 years, in separate studies, did
not exhibit any carcinogenic effect. The Department of Health and Human
Services (DHHS), the International Agency for Research on Cancer
(IARC), and EPA have not classified ethylene glycol for
carcinogenicity. Studies with people who used ethylene glycol did not
show carcinogenic effects. However, rodents fed ethylene glycol in
long-term feeding studies showed mortality.
6. Animal metabolism. Animal studies have shown that rats and dogs
are more sensitive to ethylene glycol exposure than mice. Ethylene
glycol ingestion causes metabolic acidosis and toxic calcium oxalate
production in humans and other animals. The main toxic metabolites are
glycolic acid, glyoxylic acid, and oxalic acid.
7. Metabolite toxicology. Ethylene glycol is absorbed from the
digestive tract rapidly, depleting the water in the body and breaking
down into three major metabolites; glycolic acid, glyoxylic acid, and
oxalic acid that cause harmful crystalline deposits in the body. These
metabolites are typically detected in urine. Ethylene glycol can be
detected in the blood and serum soon after ingestion, but much less so
after metabolic activity begins.
8. Endocrine disruption. Neither mice nor rats have exhibited
endocrine effects after experimental exposure.
C. Aggregate Exposure
1. Dietary exposure. Oral consumption of ethylene glycol by humans
is usually accidental, but has serious, sometimes fatal, toxicity. Oral
consumption by animals attracted by the sweet odor is an important
cause of veterinary emergencies. The oral dose of ethylene glycol
required to cause death in humans is not well defined, but a lethal
dose is estimated to be 1,330 mg/kg body weight.
i. Food. The migration of ethylene glycol from regenerated
cellulose films containing triethylene glycol and polyethylene glycol
as softening agents into food has been documented. It has also been
found to migrate into food from pet (polyethylene terephthalate)
plastic bottles used for packaging carbonated beverages. Ethylene oxide
is a commonly used food disinfectant and preservative. After treatment
with ethylene oxide, trace amounts of residual ethylene glycol may be
retained in food. Potential exposure to minute amounts of ethylene
glycol present in microencapsulated pesticides used in food and non-
food areas of food handling establishments would not be of concern.
ii. Drinking water. EPA has established several drinking water
Health Advisories for ethylene glycol. The (DWEL) Drinking Water
Equivalent Level is 70 milligrams per liter for an adult. Ethylene
glycol would only be present in drinking water by accidental release
into reservoirs. However, biodegradation is an effective method of
removing ethylene glycol from soil and water.
2. Non-dietary exposure. The most likely route of exposure to
ethylene glycol is through dermal exposure; however, dermal exposure is
not likely to lead to lethal toxic effects. Dermal exposure can occur
occupationally in production facilities, and by handling liquid
antifreeze, brake and other car and industrial fluids and solvents,
inks in stamp pads, ballpoint pens, and in print shops. Inhalation of
ethylene glycol mist may occur in industrial production, and there are
trace amounts in cigarette smoke. Dermal and inhalation exposure may
occur during airplane de-icing. Hazardous waste sites may also contain
ethylene glycol until degradation occurs. Small amounts of ethylene
glycol are also in pharmaceuticals (components of skin lotions,
powders, and as a glycerin substitute).
D. Cumulative Effects
Humans and animals are exposed to significant levels of ethylene
glycol by several routes of exposure. Available studies have not shown
that cumulative effects are seen, due to the rapid biodegradation of
ethylene glycol.
E. Safety Determination
1. U.S. population. Little information on quantitative levels in
human tissues and body fluids, populations near hazardous waste sites,
or those occupationally exposed to ethylene glycol is available. Most
exposure to the general population is through dermal contact with
products containing ethylene glycol during application or use, or by
accidental or intentional oral ingestion. Workers involved in the
manufacture or use of products containing high concentrations of
ethylene glycol are at greater risk by this exposure than the general
population, but no widespread reports of toxicity and deaths have been
located.
2. Infants and children. As ethylene glycol is mainly used in
antifreeze, hydraulic fluids and de-icing compounds, and other
industrial and consumer products, children and infants would be exposed
to it mostly by adult carelessness in use, disposal, and storage of
products containing ethylene glycol.
F. International Tolerances
No listings found.
[FR Doc. 04-17506 Filed 8-3-04; 8:45 am]
BILLING CODE 6560-50-S