[Federal Register Volume 68, Number 204 (Wednesday, October 22, 2003)]
[Notices]
[Pages 60375-60378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26667]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0345; FRL-7330-1]


Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl); 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.

-----------------------------------------------------------------------

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 ID number OPP-2003-0345, must be 
received on or before November 21, 2003.

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: James Parker, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0371; 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:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] 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-2003-0345. 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, 1921 Jefferson Davis Hwy., 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

[[Page 60376]]

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-2003-0345. 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-2003-0345. 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-2003-0345.
    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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID number OPP-2003-0324. 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

[[Page 60377]]

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: October 10, 2003.
Debra Edwards,
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 Nichino America and represents the view of 
Nichino America. 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.

 Nichino America

 PP 3E6753

     EPA has received a pesticide petition (3E6753) from Nichino 
America, 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808 
proposing, pursuant to section 408(d) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR 180.960, by 
establishing a tolerance exemption for residues of formaldehyde, 
polymer with [agrave]-[bis(1-phenylethyl)phenyl]-[ugrave]-
hydroxypoly(oxy-1,2 ethanediyl) when used as an inert ingredient in a 
pesticide product. 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

     Nichino America is petitioning that formaldehyde, polymer with 
[agrave]-[bis(1-phenylethyl)phenyl]-[ugrave]-hydroxypoly(oxy-1,2 
ethanediyl) be exempt from the requirement of a tolerance based upon 
the definition of a low risk polymer under 40 CFR 723.250(e). 
Consequently, Nichino America believes that the analytical method to 
determine residues, the residues present in plant material, and the 
magnitude of formaldehyde, polymer with [agrave]-[bis(1-
phenylethyl)phenyl]-[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) in raw 
agricultural commodities, is not relevant.

B. Toxicological Profile

    1. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl) in 
phenyl]-[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) is a polymer as 
defined 40 CFR 723.250(2)(b). It is composed of at least 3 monomer 
units and 1 other reactant.
    2. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) consists of a simple weight 
majority of the polymer molecules. The monomer sequences form 
uninterrupted strings in the polymer and distribution of the molecular 
weight of the polymer is due largely to the number of monomer units in 
the individual molecules.
    3. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) consists of a number average 
molecular weight of 1,803 with less than 0.45% of its oligomeric 
material weighing below 500 daltons and less than 0.45% of its 
oligomeric material weighing less than 1,000 daltons.
    4. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) will not become cationic in an 
aquatic environment. It contains no moieties capable of obtaining a 
cationic charge.
    5. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) is composed of carbon, 
hydrogen, and oxygen; therefore, it meets the criteria of elemental 
composition. Namely it must be composed of at least two of the 
following elements (and no other elements than those listed); carbon, 
hydrogen, nitrogen, oxygen, silicon, and sulfur.
    6. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) is not designed nor reasonably 
expected to degrade, decompose, or depolymerize under normal use 
conditions
    7. Formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) is composed of molecules that 
are listed on the TSCA Inventory or manufactured under an applicable 
TSCA section 5 exemption.
    8. Although, formaldehyde, polymer with [agrave]-[bis(1-
phenylethyl)phenyl]-[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) does not 
exceed the number average molecular weight of 10,000 and therefore is 
not subject to the water absorption limitation, it nonetheless still 
satisfies the criteria of being a non-water absorbing species.

C. Aggregate Exposure

    1. Dietary exposure. The physical-chemical characteristics of 
formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) leads to the conclusion that 
there is a reasonable certainty of no harm from exposure to the polymer 
from food or drinking water nor from an aggregate exposure.
    2. Non-dietary exposure. The physical-chemical characteristics of 
formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) lead to the conclusion that 
there is a reasonable certainty of no harm from exposure to the polymer 
from non-dietary means.

D. Cumulative Effects

     At this time there is no information to indicate that any toxic 
effects produced by formaldehyde, polymer with [agrave]-[bis(1-
phenylethyl)phenyl]-[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) would be 
cumulative with 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. Based on the polymer's physical-chemical 
properties, and that it meets or exceeds the polymer exemption criteria 
at 40 CFR 723.250 for low-risk polymers, adverse effects are not 
expected.
    2. Infants and childrens. Based on the polymer's physical-chemical 
properties, and that it meets or exceeds the polymer exemption criteria 
at 40 CFR 723.250 for low-risk polymers, adverse effects are not 
expected.

[[Page 60378]]

F. International Tolerances

     There are no CODEX maximum residue limits established for 
formaldehyde, polymer with [agrave]-[bis(1-phenylethyl)phenyl]-
[ugrave]-hydroxypoly(oxy-1,2 ethanediyl) in or on crops or commodities 
at this time.

[FR Doc. 03-26667 Filed 10-21-03; 8:45 am]
BILLING CODE 6560-50-S