[Federal Register Volume 69, Number 236 (Thursday, December 9, 2004)]
[Notices]
[Pages 71405-71408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27032]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0386; FRL-7687-8]


Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine ethyleneimine polymer; 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-
2004-0386, must be received on or before January 10, 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: 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: <a href="/cdn-cgi/l/email-protection#5d3a3c33393534733f342d34331d382d3c733a322b"><span class="__cf_email__" data-cfemail="dcbbbdb2b8b4b5f2beb5acb5b29cb9acbdf2bbb3aa">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> 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

[[Page 71406]]

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-2004-0386. 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 <greek-i>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. 
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-2004-0386. 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 <a href="/cdn-cgi/l/email-protection#f39c8383de979c90989687b3968392dd949c85"><span class="__cf_email__" data-cfemail="b9d6c9c994ddd6dad2dccdf9dcc9d897ded6cf">[email protected]</span></a>, 
Attention: Docket ID number OPP-2004-0386. 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),

[[Page 71407]]

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2004-0386.
    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 
<greek-i>2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0386. 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, Food 
additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: November 30, 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 Cognis Corporation 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.

 Cognis Corporation

 PP 4E6868

     EPA has received a pesticide petition (4E6868) from Cognis 
Corporation, 4900 Este Avenue, Cincinnati, OH 45234 proposing, pursuant 
to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 
180.960 to establish an exemption from the requirement of a tolerance 
for amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer, (CAS Reg. No. 192230-19-6) in 
or on all raw agricultural commodities when used as an inert ingredient 
in the pesticide formulations. 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

    1. Plant metabolism. Cognis is petitioning the Agency to exempt 
amides, from acetic acid, C5-9 carboxylic acids and diethylenetriamine-
ethyleneimine polymer from the requirement of a tolerance since this 
inert ingredient meets the exemption criteria for low-risk polymers 
under 40 CFR 723.250. Consequently, plant metabolism data are not 
necessary.
    2. Analytical method. Since the petitioner is requesting a 
tolerance exemption, an analytical method for residues of the polymer 
in or on food crops is not required.

B. Toxicological Profile

     When it can be determined that an inert ingredient meets the 
definition of an exempt or low-risk polymer (40 CFR 723.250) then the 
production of data is generally not required by EPA to establish a 
tolerance or an exemption from a tolerance. Cognis Corporation asserts 
that the data and information provided below are sufficient to 
establish the potential activity, toxicity and risks associated with 
amides, from acetic acid, C5-9 carboxylic acids and diethylenetriamine-
ethyleneimine polymer as an inert ingredient when applied to growing 
crops or raw agricultural commodities. Further, in the case of chemical 
substances described as polymers, EPA has established criteria, which 
when they are met or exceeded, are considered low-risk. These criteria 
are described in 40 CFR 723.250 and identify polymers that are 
relatively unreactive, stable, and typically not absorbed when compared 
to other chemical substances including some polymers.
     The criteria described in 40 CFR 723.250, and addressed below, 
will generally exclude polymer chemicals that are not well-known and 
understood, and potentially present a significant risk of adverse 
effects. Therefore, the polymers that meet or exceed these criteria can 
be considered minimal or negligible risk.
     As presented below, amides, from acetic acid, C5-9 carboxylic 
acids and

[[Page 71408]]

diethylenetriamine-ethyleneimine polymer conforms to the definition of 
a low-risk polymer as described in 40 CFR 723.250.
     a. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer is not a cationic polymer, nor 
is it reasonably anticipated to become a cationic polymer in a natural 
aquatic environment.
     b. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer contain as the integral part 
of its composition, the atomic elements of hydrogen, oxygen, nitrogen, 
and carbon.
     c. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer do not contain as an integral 
part of its composition, except as impurities, any elements other than 
those listed in 40 CFR 723.250(d)(2)(ii).
     d. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer are not designed nor 
reasonably anticipated to substantially depolymerize, degrade, or 
decompose.
     e. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer are manufactured from monomers 
that are listed in the Toxic Substances Control Act (TSCA) Chemical 
Substance Inventory or manufactured under an applicable TSCA section 5 
exemption.
     f. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer are not a water absorbing 
polymer.
     g. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer do not contain any reactive 
functional groups.
     h. The minimum number-average molecular weight of amides, from 
acetic acid, C5-9 carboxylic acids and diethylenetriamine-ethyleneimine 
polymer is approximately 1,400 daltons. Substances with molecular 
weights greater than 400 daltons are generally not absorbed through the 
intact skin, and substances with molecular weights greater than 1,000 
daltons are generally not absorbed through the intact gastrointestinal 
(GI). Chemicals not absorbed through the GI tract are incapable of 
eliciting a toxic response via these routes of exposure.
    i. Amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer contain less than 10% 
oligomeric material below molecular weight of 500 daltons and less than 
25% oligomeric material below 1,000 daltons.

C. Aggregate Exposure

    1. Dietary exposure. Since amides, from acetic acid, C5-9 
carboxylic acids and diethylenetriamine-ethyleneimine polymer are 
considered a low-risk polymer, there is a reasonable certainty of no 
harm from exposure to this polymer from food or drinking water or from 
aggregate exposure.
    2. Non-dietary exposure. Since amides, from acetic acid, C5-9 
carboxylic acids and diethylenetriamine-ethyleneimine polymer are 
considered a low-risk polymer, there is a reasonable certainty of no 
harm from exposure to this polymer from non-dietary means.

D. Cumulative Effects

     At this time, there is no information to indicate that any toxic 
effects produced by amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer are cumulative with those of 
any other chemical. Given the compound's categorization as a low-risk 
polymer, and its proposed use in pesticide formulations, there is no 
expectation of increased risk due to cumulative exposure.

E. Safety Determination

    1. U.S. population. Since amides, from acetic acid, C5-9 carboxylic 
acids and diethylenetriamine-ethyleneimine polymer are considered a 
low-risk polymer, no adverse effects of concern to the U.S. population 
are expected.
    2. Infants and children. Since amides, from acetic acid, C5-9 
carboxylic acids and diethylenetriamine-ethyleneimine polymer are 
considered a low-risk polymer, no adverse effects of concern to either 
infants or children are anticipated.

F. International Tolerances

     There are no Codex maximum residue levels established for residues 
of amides, from acetic acid, C5-9 carboxylic acids and 
diethylenetriamine-ethyleneimine polymer in or on crops or commodities 
at this time.

[FR Doc. 04-27032 Filed 12-8-04; 8:45 am]
BILLING CODE 6560-50-S


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