[Federal Register Volume 68, Number 9 (Tuesday, January 14, 2003)]
[Notices]
[Pages 1846-1849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-739]


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

ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0359; FRL-7286-5]


Modified Acrylic 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.

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

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-2002-0359, must be 
received on or before February 13, 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:  Treva C. Alston, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8373; 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 25532)
     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-2002-0359. 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

[[Page 1847]]

collection of materials that are 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 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-2002-0359. 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-2002-0359. 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-2002-0359.
    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-2002-0359. 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

[[Page 1848]]

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: January 2, 2003.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

 Summary of Petition

     The petitioner summary of the pesticide petition is printed below 
as required by the Federal Food, Drug, and Cosmetic Act (FFDCA) section 
408(d)(3). The summary of the petition was prepared by Alco Chemical, 
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.

 Alco Chemical

PP 3E6539

     EPA has received a pesticide petition ([3E6539]) from Alco 
Chemical, 909 Mueller Drive, Chattanooga, TN 37406-0401 proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to revise an existing exemption from the 
requirement of a tolerance for modified acrylic polymers located in 40 
CFR 180.960 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.
     The existing tolerance exemption reads as follows: Acrylic 
polymers composed of one or more of the following monomers: Acrylic 
acid, methyl acrylate, ethyl acrylate, butyl acrylate, hydroxyethyl 
acrylate, hydroxypropyl acrylate, hydroxybutyl acrylate, carboxyethyl 
acrylate, methacrylic acid, methyl methacrylate, ethyl methacrylate, 
butyl methacrylate, isobutyl methacrylate, hydroxyethyl methacrylate, 
hydroxypropyl methacrylate, hydroxybutyl methacrylate, lauryl 
methacrylate, and stearyl methacrylate; with none and/or one or more of 
the following monomers: Acrylamide, N-methyl acrylamide, N-
octylacrylamide, maleic anhydride, maleic acid, monoethyl maleate, 
diethyl maleate, monooctyl maleate, dioctyl maleate; and their 
corresponding sodium potassium, ammonium, isopropylamine, 
triethylamine, monoethanolamine, and/or triethanolamine salts; the 
resulting polymer having a minimum number average molecular weight (in 
amu), 1,200. No CAS registry number is associated with the exemption.
    Alco Chemical Company is requesting that the exemption be revised 
to include N,N-dimethyl acrylamide by inserting N,N-dimethyl acrylamide 
between N-methyl acrylamide and N-octyl acrylamide.
     Magnitude of residues. Alco is petitioning for an exemption from 
the requirement of a tolerance based upon the polymer's compliance with 
the Low Risk Polymer criteria per 40 CFR 723.250. Therefore, an 
analytical method to determine residues in raw agricultural commodities 
has not been proposed. No residue chemistry data or environmental fate 
data are presented in the petition as the Agency does not generally 
require some or all of the listed studies to rule on the exemption from 
the requirement of a tolerance for a low risk polymer inert ingredient.

A. Toxicological Profile

     The Agency has established a set of criteria which identifies 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compared to other chemical substances, as well as, polymers that 
typically are not readily absorbed. Alco believes that N,N-dimethyl 
acrylamide acrylic acid polymers conform to the definition of a polymer 
given in 40 CFR 723.250 and meets the criteria used to identify a low 
risk polymer. Alco also believes that based on this substance's 
conformance to the above mentioned criteria, no mammalian toxicity is 
anticipated from dietary, inhalation or dermal exposure to emulsion 
polymers and that emulsion polymers will present minimal or no risk.
    1. This polymer is not a cationic substance.
    2. It contains as an integral part of its composition the atomic 
elements carbon, hydrogen, and oxygen.
    3. It 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).

[[Page 1849]]

    4. This polymer is not designed or reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. It is not manufactured or imported from monomers and/or other 
reactants that are not already on the TSCA Chemical Substance Inventory 
or manufactured under an applicable TSCA Section 5 exemption.
    6. It is not a water absorbing polymer.
    7. The minimum average molecular weight of the above mentioned 
polymer is greater than 10,000. Substances with molecular weights 
greater than 400 are generally not readily absorbed through the intact 
skin, and substances with molecular weights greater than 1,000 are 
generally not absorbed through the intact gastrointestinal (GI) tract. 
Chemicals not absorbed through the GI tract are generally incapable of 
eliciting a toxic response. This polymer has an oligomer content less 
than 2% below MW 500 and less than 5% MW 1,000.
     Alco believes sufficient information was submitted in the petition 
to assess the hazards of the N,N-dimethyl acrylamide acrylic acid 
polymer. No toxicology data were presented in the petition as the 
Agency does not generally require some or all of the listed studies to 
rule on the exemption from the requirement of a tolerance for an inert 
ingredient. Based on this polymer's conforming to the definition of a 
polymer and meeting the criteria of a low risk polymer under 40 CFR 
723.250, Alco believes there are no concerns for risks associated with 
toxicity.
    8. Endocrine disruption. There is no evidence that the polymer is 
an endocrine disrupter. Substances 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 intact gastrointestinal (GI) tract. Chemicals not absorbed 
through the skin or GI tract generally are incapable of eliciting a 
toxic response.

B. Aggregate Exposure

    1. Dietary exposure. Some modified acrylic polymers may be used in 
contact with food as components of containers used to manufacture, 
process, or store food when regulated for such use under the FFDCA. 
Modified acrylic polymers with a molecular weight greater than 1,000 
daltons are not readily absorbed through the intact gastrointestinal 
tract and are considered incapable of eliciting a toxic response.
    2. Non-dietary exposure. Typical uses of modified acrylic polymers 
are in the inks and coatings and industrial water treatment industries. 
In these uses the primary exposures are dermal, however, modified 
acrylic polymers with a molecular weight significantly greater than 400 
are not readily absorbed through the intact skin and are considered 
incapable of eliciting a toxic response.

C. Cumulative Effects

     There is data to support a conclusion of negligible cumulative 
risk for modified acrylic polymers. 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 intact gastrointestinal (GI) tract. Chemicals 
not absorbed through the skin or GI tract generally are incapable of 
eliciting a toxic response. Therefore, there is no reasonable 
expectation of increased risk due to cumulative exposure. Based on this 
polymer conforming to the definition of a polymer and meeting the 
criteria of a low risk polymer under 40 CFR 723.250, Alco believes 
there are no concerns for risks associated with cumulative effects.

[FR Doc. 03-739 Filed 1-13-03; 8:45 am]
BILLING CODE 6560-50-S