[Federal Register Volume 69, Number 180 (Friday, September 17, 2004)]
[Notices]
[Pages 56062-56066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20912]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0285; FRL-7675-9]


1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis 2-chloroethane; 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-
2004-0285, must be received on or before October 18, 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].

[[Page 56063]]


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 code 111)
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 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-2004-0285. 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 South 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. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on 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-2004-0285. 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.

[[Page 56064]]

    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID number OPP-2004-0285. 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-2004-0285.
    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 South Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0285. 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: September 1, 2004.
Donald R. Stubbs,
 Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner's summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by Buckman Laboratories International, Inc., 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.

 Buckman Laboratories International, Inc.

 PP 4E6841

     EPA has received a pesticide petition PP 4E6841 from Buckman 
Laboratories International, Inc., 1256 North McLean Blvd., Memphis, TN 
38108, proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 
346a(d), to amend 40 CFR 180.920 to establish an exemption from the 
requirement of a tolerance for 1,2-ethanediamine, N, N, N', N'-
tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] (CAS Reg. No. 
31075-24-8) in or on raw agricultural commodities when used as an inert 
ingredient in or on growing crops. 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 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

     Buckman is petitioning that the inert ingredient, 1,2-
ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-
chloroethane], be exempt from the requirement of a tolerance because 
the chemical meets all but one of the criteria that define a low risk 
polymer under 40 CFR 723.250(e). For this reason, neither plant 
metabolism data, residue data, nor an analytical method to determine 
residues of 1,2-ethanediamine, N, N, N', N'-tetramethyl-

[[Page 56065]]

, polymer with 1, 1'-oxybis[2-chloroethane] in raw agricultural 
commodities (RACs) are required.

B. Toxicological Profile

     In the case of certain substances that are defined as 
``polymers,'' the Agency has established a set of criteria that 
identify categories of polymers that present low risk. These criteria, 
described in 40 CFR 723.250, identify polymers that are typically not 
readily absorbed, and are relatively unreactive and stable compounds in 
comparison to other chemical substances. These properties generally 
limit a polymer's ability to cause adverse effects. In addition, these 
criteria exclude polymers about which little is known. The Agency 
believes that polymers that meet the criteria in 40 CFR 723.250 will 
present minimal or no risk to human health.
     1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis[2-chloroethane] meets all but one of the exemption criteria in 
40 CFR 723.250. That one exception is that 1,2-ethanediamine, N, N, N', 
N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] is a 
cationic polymer. Cationic polymers are excluded because of their 
typically inherent aquatic toxicity; however, 1,2-ethanediamine, N, N, 
N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] does not 
behave like a typical cationic polymer in the field. Environmental fate 
and toxicity data for 1,2-ethanediamine, N, N, N', N'-tetramethyl-, 
polymer with 1, 1'-oxybis[2-chloroethane] demonstrate that under 
natural conditions 1,2-ethanediamine, N, N, N', N'-tetramethyl-, 
polymer with 1, 1'-oxybis[2-chloroethane] binds tightly to organic 
material and, as a result, aquatic toxicity under field conditions is 
very low. For this reason, 1,2-ethanediamine, N, N, N', N'-tetramethyl-
, polymer with 1, 1'-oxybis[2-chloroethane] should not be excluded on 
the basis that it is cationic because data are available that show that 
aquatic toxicity under field conditions is very low.
     In all other respects, as listed below, 1,2-ethanediamine, N, N, 
N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] meets 
the polymer exemption criteria described in 40 CFR 723.250(d):
    1. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] contains as an integral part of its 
composition the atomic elements carbon, hydrogen, oxygen, nitrogen and 
chloride ion.
    2. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250 (d)(2)(ii).
    3. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] is neither designed nor can it be reasonably 
anticipated to substantially degrade, decompose, or depolymerize.
    4. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] is manufactured or imported from monomers 
and/or reactants that are already included on the TSCA Chemical 
Substance Inventory or manufactured under an applicable TSCA section 5 
exemption.
    5. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] is not a water-absorbing polymer with a 
number average MW greater than or equal to 10,000 daltons. The number 
average MW is about 2,000 and the MW is around 3,000-5,000 daltons.
     Additionally, 1,2-ethanediamine, N, N, N', N'-tetramethyl-, 
polymer with 1, 1'-oxybis[2-chloroethane] meets as required the 
following criteria specified in 40 CFR 723.250(e):
    6. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 
1'-oxybis[2-chloroethane] has a number average MW of about 2,000, which 
is greater than 1,000 and less than 10,000 daltons. The polymer 
contains less than 10% oligomeric material below MW 1,000 and the 
polymer does not contain any reactive functional groups.
     1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis[2-chloroethane] has the same chemical composition as Busan 77, a 
pesticide active ingredient registered by Buckman for non-food 
antimicrobial uses. As a result, a complete set of mammalian toxicology 
studies have been submitted, and reviewed and evaluated by the Agency. 
A summary of the mammalian toxicology studies follows:
    1. Acute toxicity. 1,2-Ethanediamine, N, N, N', N'-tetramethyl-, 
polymer with 1, 1'-oxybis[2-chloroethane] exhibits moderate to low 
acute toxicity. The rat acute oral LD50 is 1,951 milligrams/
kilogram (mg/kg) for males and 2,587 mg/kg for females (Toxicity 
Category III). In the rabbit acute dermal toxicity study, the 
LD50 was demonstrated to be >2,000 mg/kg (Toxicity Category 
III). The rat acute inhalation toxicity study concluded that the 
LC50 is 2.9 milligrams/Liter (mg/L) for males and females 
combined (Toxicity Category IV).
     1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis[2-chloroethane] was slightly irritating (Toxicity Category III) 
in the primary eye irritation study in rabbits and minimally irritating 
(Toxicity Category IV) in the rabbit primary skin irritation study. 
1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis[2-chloroethane] is not a skin sensitizer.
    2. Genotoxicity. Four mutagenicity studies have been conducted and 
none of them demonstrated any genotoxic potential to be associated with 
the test material. The Ames Salmonella assay was negative with and 
without metabolic activation. Unscheduled DNA synthesis in primary rat 
hepatocytes in cultures was negative at dose levels up to 1,500 mg/kg. 
The mouse micronucleus assay was negative at dose levels tested up to 
2,000 mg/kg. The sex-linked recessive lethal assay was negative at all 
dose levels tested: 0.08, 0.3 or 0.8 mg/mL.
    3. Reproductive and developmental toxicity. In a rat teratology 
study, no effects were observed when the dose was administered during 
organogenisis. Some toxic effects were observed at high dose levels 
when the dose was administered during early gestation, but no 
teratogenic effects were observed. The maternal systemic lowest 
observable effect level (LOEL) was <6,000 parts per million (ppm) (300 
mg/kg/day) or less. The no observable effect level (NOEL) was less than 
6,000 ppm (300 mg/kg/day). The reproductive LOEL was 12,000 ppm (600 
mg/kg/day) based on decreased live pups. The NOEL was 6,000 ppm (300 
mg/kg/day).
     In rabbits, no evidence of developmental toxicity was observed. 
The maternal toxicity NOEL and LOEL were determined to be 45 mg/kg/day 
and 125 mg/kg/day the highest dose tested, respectively. The NOEL and 
LOEL were the same for developmental toxicity. In the two-generation 
rat reproduction study, body weight and food consumption changes were 
noted in the mid-dose (12,000 ppm) and high-dose (18,000 ppm) dose 
animals. The mid-dose and high-dose groups showed a reduction in the 
number of live pups in both generations and showed some evidence of 
kidney mineralization. The NOEL for parental in-life and pathology data 
was less than 6,000 ppm in the diet. The NOEL for reproductive effects 
was 6,000 ppm (300 mg/kg/day) in the diet.
    4. Subchronic toxicity. The systemic NOEL was 3,000 ppm (221 mg/kg/
day) in the diet in a 90-day rat study. The LOEL was 10,000 ppm (752 
mg/kg/day). Dose dependent mineralization of the kidney tubules was 
observed and at 40,000 ppm (3,685 mg/kg/day),

[[Page 56066]]

inflammation of the choroid plexus occurred. In a 90-day dermal study 
in rabbits, the NOEL for systemic toxicity was greater than 1,000 mg/
kg/day (highest dose tested). The NOEL for dermal irritation 
(localized) was 10 mg/kg/day and the LOEL was 100 mg/kg/day.
    5. Chronic toxicity. In a 52-week dog study, the NOEL was 10,000 
ppm (250 mg/kg/day) and the LOEL was 20,000 ppm (500 mg/kg/day) in 
males. In females, the NOEL was 10,000 ppm (250 mg/kg/day) and the LOEL 
was 40,000 ppm (1,000 mg/kg/day). There was a dose-related decrease in 
body weight gain and in changes in some clinical chemistry/hematology 
parameters. The only histology findings were thickening of the wall of 
the GI tract in the high dose group (40,000 ppm) and changes in sperm 
growth/maturation in some of the mid (20,000 ppm ) and high dose 
(40,000 ppm) males.
     In a 2-year combined chronic toxicity and carcinogenicity study in 
rats, body weight and food consumption values were generally lower with 
increasing dose. Survival increased with dose. There were some dose-
related effects in several clinical chemistry/hematology parameters. 
Histological exams showed mineralization in the brains of high dose 
animals and a possible increase in thyroid C-cell adenomas in females 
given 6,000 (300 mg/kg/day) and 18,000 ppm (900 mg/kg/day). This 
product is not considered a carcinogen. The NOEL for systemic toxicity 
was determined to be 2,000 ppm (100 mg/kg/day).
     In a 78-week oncogenicity study in mice, dietary administration 
produced reduced body weight gains in both males and females. Kidney 
cysts were observed in the high dose animals. There was no evidence of 
any oncogenic (cancer) activity that would be considered treatment 
related. The systemic NOEL could not be established but the LOEL was 
determined to be less than 600 mg/kg/day (4,000 ppm). 1,2-
Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-
chloroethane] was found not to be carcinogenic in mice at doses up to 
2,400 mg/kg/day (16,000 ppm) in the diet.
    6. Animal metabolism. In a rat metabolism study, test animals were 
dosed with 14C-labeled 1,2-ethanediamine, N, N, N', N'-
tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] at oral or 
intravenous doses of 10 mg/kg, an oral dose of 1,000 mg/kg or at 
repeated oral doses (14 daily doses) of unlabeled 1,2-ethanediamine, N, 
N, N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] at 10 
mg/kg followed by administration of a single oral dose of labeled 1,2-
ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-
chloroethane] at 10 mg/kg. Expired 14CO2 was not 
detected.
     In the intravenous dose group, the major routes of excretion of 
radioactivity were via the urine and feces. Over a 7-day period, 
approximately half (52-55%) of the test compound administered was 
excreted in the urine (38-44%) and feces (11-14%) from the animals.
     In the single oral dose and repeated oral dose groups, most (88%-
106%) of the test compound administered was excreted in the urine (3% 
of the dose) and feces (85-103% of the dose). In the oral dosed groups, 
the highest amount of residual radioactivity was found in kidneys, 
liver and spleen. The residues in the tissues including carcass were 
not more than 0.14%. This indicates that the potential for 
bioaccumulation of 1,2-ethanediamine, N, N, N', N'-tetramethyl-, 
polymer with 1, 1'-oxybis[2-chloroethane] is minimal after low single 
or repeated oral dose exposures. In the high (1,000 mg/kg) oral dose 
group, most (85%) of the dose was excreted in urine (14-17% of the 
dose) and feces (68-71%). Seven days after dosing, residues were low in 
all tissues except for the kidneys, liver and spleen in this group.

C. Aggregate Exposure

     1,2-Ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-
oxybis[2-chloroethane] is a polymer with a high molecular weight (3,000 
- 5,000 daltons) that is not expected to be absorbed through the intact 
gastrointestinal (GI) tract or through intact human skin, therefore, it 
would not be capable of eliciting a toxic response. For this reason, 
health risks from potential exposure to 1,2-ethanediamine, N, N, N', 
N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] in food or 
drinking water as well as non-dietary exposure are expected to be 
negligible.

D. Cumulative Effects

     Polymers with molecular weights greater than 400 generally are not 
absorbed through the intact skin and substances with molecular weights 
greater than 1,000 generally are not absorbed through the GI tract. 
Chemicals that are not absorbed through the skin or GI tract generally 
are incapable of eliciting a toxic response. 1,2-ethanediamine, N, N, 
N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] has a 
molecular weight of 3,000 - 5,000, therefore, there is no reasonable 
expectation of risk due to cumulative exposure.

E. Safety Determination

     There are no safety concerns with 1,2-ethanediamine, N, N, N', N'-
tetramethyl-, polymer with 1, 1'-oxybis[2-chloroethane] because it 
conforms to the definition of a low risk polymer given in 40 CFR 
723.250 and is considered to be incapable of eliciting a toxic response 
because it is not expected to be absorbed through the intact skin or 
intact GI tract.

F. International Tolerances

     Buckman is not aware of any country requiring a tolerance for 1,2-
ethanediamine, N, N, N', N'-tetramethyl-, polymer with 1, 1'-oxybis[2-
chloroethane], nor have there been any Codex maximum residue levels 
established for any food crops at this time.
[FR Doc. 04-20912 Filed 9-16-04; 8:45 am]
BILLING CODE 6560-50-S