[Federal Register Volume 70, Number 104 (Wednesday, June 1, 2005)]
[Notices]
[Pages 31453-31455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-10848]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0103; FRL-7711-2]


[alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) Block Polymer 
with poly(oxyethylene); 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-
2005-0103, must be received on or before July 1, 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: Kathleen Martin, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-2857; 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-2005-0103. 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 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 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.

[[Page 31454]]

    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-2005-0103. 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-2005-0103. 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-2005-0103.
    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-2005-0103. 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: May 19, 2005.
Lois A. Rossi,
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 BASF 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.

 BASF Corporation

 PP 5E6917

     EPA has received a pesticide petition (5E6917) from BASF 
Corporation, 100 Campus Drive, Florham Park, NJ, 07932, proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to

[[Page 31455]]

amend 40 CFR part 180 to establish an exemption from the requirement of 
a tolerance for [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) when used in a pesticide. 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

     BASF Corporation is petitioning that [alpha]-Butyl-[omega]-
hydroxypoly(oxypropylene) block polymer with poly(oxyethylene) be 
exempt from the requirement of a tolerance based upon the definition of 
a low risk polymer under 40 CFR 723.250(e). Consequently, BASF 
Corporation believes that the analytical method to determine residues, 
the residues present in plant material, and the magnitude of [alpha]-
Butyl-[omega]-hydroxypoly(oxypropylene) block polymer with 
poly(oxyethylene) in raw agricultural commodities, is not relevant.

B. Toxicological Profile

     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) is a polymer as defined by 40 CFR 
723.250(b). It is composed of at least three monomer units and one 
other reactant.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) 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.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) consists of a number average molecular 
weight of 4,000 with 0% of its oligomeric material weighing below 500 
daltons and 0% of its oligomeric material weighing less than 1,000 
daltons.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) will not become cationic in an aquatic 
environment. It contains no moieties capable of obtaining a cationic 
charge.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) 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.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) is not designed nor reasonably expected 
to degrade, decompose, or depolymerize under normal use conditions.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) is composed of molecules that are listed 
on the TSCA Inventory or manufactured under an applicable TSCA section 
5 exemption.
     [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block 
polymer with poly(oxyethylene) does not exceed the number average 
molecular weight of 10,000 and; therefore, is not subject to the water 
absorption limitation.

C. Aggregate Exposure

    1. Dietary exposure. The physical-chemical characteristics of 
[alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block polymer with 
poly(oxyethylene) 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 
[alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) block polymer with 
poly(oxyethylene) 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 [alpha]-Butyl-[omega]-hydroxypoly(oxypropylene) 
block polymer with poly(oxyethylene) 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 children. 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.

F. International Tolerances

     There are no Codex maximum residue limits established for [alpha]-
Butyl-[omega]-hydroxypoly(oxypropylene) block polymer with 
poly(oxyethylene) in or on crops or commodities at this time.
[FR Doc. 05-10848 Filed 5-31-05; 8:45 am]
BILLING CODE 6560-50-S