[Federal Register Volume 69, Number 149 (Wednesday, August 4, 2004)]
[Notices]
[Pages 47149-47152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17506]


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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: [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.

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 [email protected], 
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.

[[Page 47152]]

    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