[Federal Register Volume 67, Number 221 (Friday, November 15, 2002)]
[Notices]
[Pages 69217-69220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-29056]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0284; FRL-7280-1]


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 ID number OPP-2002-0284, must be 
received on or before December 16, 2002.

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, pesticide manufacturer, or 
antimicrobial pesticide manufacturer. Potentially affected entities may 
include, but are not limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop Production
                                            112  Animal Production
                                            311  Food manufacturing
                                          32532  Pesticide Manufacturing
                                          32561  Antimicrobial Pesticide
------------------------------------------------------------------------

    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 identification (ID) number OPP-2002-0284. 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

[[Page 69218]]

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 restriced 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-2002-0284. 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-2002-0284. 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-2002-0284.
    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-2002-0284. 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.

[[Page 69219]]

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: November 6, 2002.
Debra Edwards,
Acting 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 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.

Rhodia, Inc.,

PP 2E6515

    EPA has received a pesticide petition (2E6515) from Rhodia, Inc., 
CN 7500, Prospect Plains Rd., Cranbury, NJ 08512-7500, 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 part 180 to establish an 
exemption from the requirement of a tolerance for 1,3-Benzene 
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium salt, polymer 
with 1,3-benzenedicarboxylic acid, 1,4-benzene dicarboxylic acid, 
dimethyl 1,4-benzenedicarboxylate and 1,2 ethanediol (CAS Reg. No. 
212842-88-1) when used as an inert ingredient in pesticide formulations 
under 40 CFR 180.960 (polymers). 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

    Rhodia, Inc. is petitioning that 1,3-Benzene dicarboxylic acid, 5-
sulfo-, 1,3-dimethyl ester, Sodium salt, polymer with 1,3-
benzenedicarboxylic acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-
benzene dicarboxylate and 1,2 ethanediol be exempt from the requirement 
of a tolerance based upon the definition of a low risk polymer under 40 
CFR 723.250(e). Consequently, the analytical method to determine 
residues, the residues present in plant material, and the magnitude of 
1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium 
salt, polymer with 1,3-benzenedicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol residues in raw agricultural commodities is not relevant.

B. Toxicological Profile

    Where it can be determined that an inert ingredient meets the 
definition of a low risk polymer (40 CFR 723.250), then the production 
of data is generally not required by EPA to establish a tolerance or 
the exemption from a tolerance. Rhodia, Inc. asserts that the data and 
information provided below is sufficient to establish the activity and 
toxicity associated with 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-
dimethyl ester, Sodium salt, with polymer with 1,3-benzenedicarboxylic 
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate 
and 1,2 ethanediol 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 the polymers that are relatively unreactive, stable, and 
typically are not absorbed when compared to other chemical substances 
including some polymers. Rhodia, Inc. has previously submitted 
information regarding 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-
dimethyl ester, Sodium salt, with polymer 1,3-benzene dicarboxylic 
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate 
and 1,2 ethanediol to the Environmental Protection Agency in a Pre 
Manufacturing Notice for consideration under the polymer exemption rule 
(PMN Number P96-818).
    The criteria described in 40 CFR 723.250, and addressed below, will 
generally exclude polymer chemicals that are not well known and 
understood, and present great risk of adverse effects. Therefore, the 
polymers that meet or exceed these criteria can be considered of 
minimal or no risk.
    1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium 
salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol conforms to the definition of a low risk polymer as 
described in 40 CFR 723.250 as described below:
    a. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol is not a cationic polymer, nor is it reasonably anticipated 
to become a cationic polymer in a natural aquatic environment.
    b. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol contains as the integral part of its composition the atomic 
elements hydrogen, oxygen, carbon, and sulfur.
    c.1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and

[[Page 69220]]

1,2 ethanediol does 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.1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol is not designed nor reasonably anticipated to substantially 
depolymerize, degrade, or decompose.
    e. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol is manufactured from monomers that are listed in the Toxic 
Substance Control Act (TSCA) Chemical Substance Inventory or 
manufactured under an applicable TSCA section 5 exemption.
    f. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol is not a water-absorbing polymer.
    g. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol does not contain any reactive functional groups.
    h. The minimum number-average molecular weight of 1,3-Benzene 
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium salt, polymer 
with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid, 
dimethyl 1,4-benzene dicarboxylate and 1,2 ethanediol is 2,580 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 generally are not absorbed through 
the intact gastrointestinal (GI) tract. Chemicals not absorbed through 
the skin or GI tract are incapable of eliciting a toxic response via 
these routes of exposure.
    i. 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, 
Sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol has a number average molecular weight of approximately 2,580 
Daltons and contains less than 4.3% oligomeric material below molecular 
weight of 500 Daltons and less than 7.0% oligomeric material below 
1,000 molecular weight.

C. Aggregate Exposure

    1. Dietary exposure. The physical-chemical characteristics of 1,3-
Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium salt, 
polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic 
acid, dimethyl 1,4-benzene dicarboxylate and 1,2 ethanediol lead 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 
1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium 
salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene 
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2 
ethanediol 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 1,3-Benzene dicarboxylic acid, 5-sulfo-, 1,3-
dimethyl ester, Sodium salt, polymer with 1,3-benzene dicarboxylic 
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate 
and 1,2 ethanediol would be 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. 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 1,3-
Benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, Sodium salt, 
polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic 
acid, dimethyl 1,4-benzene dicarboxylate and 1,2 ethanediol in or on 
crops or commodities at this time.
[FR Doc. 02-29056 Filed 11-14-02; 8:45 am]
BILLING CODE 6560-50-S