[Federal Register Volume 67, Number 235 (Friday, December 6, 2002)]
[Notices]
[Pages 72675-72678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30946]



[[Page 72675]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0319; FRL-7281-9]


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-2002-0319, must be 
received on or before January 6, 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: 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:
    [bull] Industry (NAICS 111), e.g., Crop Production.
    [bull] Industry (NAICS 112), e.g., Animal Production.
    [bull] Industry (NAICS 311), e.g., Food manufacturing.
    [bull] Industry (NAICS 32532), e.g., Pesticide Manufacturing.
    [bull] Industry (NAICS 32561), e.g., 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-2002-0319. 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 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-

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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-2002-0319. 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-2002-0319. 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-2002-0319.
    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-2002-0319. 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: November 20, 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.

 3E6523

    EPA has received a pesticide petition (PP 3E6523) from Akzo Nobel 
Industrial Specialties, Inc., 15200 Almeda Road, Houston, TX 77053 
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 [alpha]-Hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates, 
poly(oxyethylene) content is 4-12 moles. EPA has determined that the 
petition contains data or information

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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

    Analytical method. Akzo Nobel is petitioning that [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates be 
exempt from the requirement of a tolerance based upon the definition of 
a low risk polymer under 40 CFR 723.250(e). Therefore, an analytical 
method to determine residues of [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates in 
raw agricultural commodities (RACs) is not required.

B. Toxicological Profile

    As part of the EPA policy statement on inert ingredients, the 
Agency set forth a list of studies which would generally be used to 
evaluate the risks posed by the presence of an inert ingredient in a 
pesticide formulation. However, where it can be determined without the 
data that the inert ingredient will present minimal or no risk, the 
Agency generally does not require some or all of the required studies 
to rule on the proposed tolerance or exemption from the requirement of 
a tolerance for an inert ingredient. Akzo Nobel Industrial Specialties, 
Inc. believes that the data and the information described below are 
adequate to ascertain the toxicology and characterize the risk 
associated with the use of [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates, 
poly(oxyethylene) content is 4-12 moles which represent C8 
alkyl ether citrate (CAS Registration Number: 330977-00-9), 
C10-C16 alkyl ether citrates (CAS Registration 
Number: 330985-58-5) and C16-C18-alkyl ether 
citrates (CAS Registration Number: 330985-61-0) as inert ingredients in 
pesticide formulations.
    In the case of certain chemical substances that are defined as 
``polymers'' the EPA has established a set of criteria which identify 
categories of polymers that present low risk. These criteria (codified 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compared to other chemical substances as well as polymers that 
are not readily absorbed. These properties generally limit a polymer's 
ability to cause adverse effects. In addition, these criteria exclude 
polymers about which little is known. The EPA believes that polymers 
meeting the criteria noted below will present minimal or no risk.
    [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates, poly(oxyethylene) content is 4-12 moles which represent 
C8 alkyl ether citrate (CAS Registration Number: 330977-00-
9), C10-C16 alkyl ether citrates (CAS 
Registration Number: 330985-58-5) and C16-C18-
alkyl ether citrates (CAS Registration Number: 330985-61-0) conform to 
the definition of a polymer given in 40 CFR 723.250(b) and meet the 
following criteria that are used to identify low risk polymers.
    1. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates are not cationic polymers, nor are they reasonably anticipated 
to become cationic polymers in a natural aquatic environment.
    2. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates contain as an integral part of their composition the atomic 
elements carbon, oxygen, and hydrogen.
    3. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates do not contain as an integral part of their composition any 
elements other those listed in 40 CFR 723.250(d)(2)(ii).
    4. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates are not designed, nor are they reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates are not manufactured or imported from monomers and/or other 
reactants that are not already included on the Toxic Substances Control 
Act (TSCA) Chemical Substance Inventory or manufactured under an 
applicable TSCA section 5 exemption.
    6. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates are not water absorbing polymers.
    7. [alpha]-Hydro-[]-
hydroxy-poly(oxyethylene) C8-C18-alkyl ether 
citrates do not contain any group as reactive functional groups.
    8. The minimum number-average molecular weights of polymers 
represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates are 
listed as shown below:
    [bull] C8 alkyl ether citrate (CAS Registration Number: 
330977-00-9) 1,300 daltons
    [bull] C10-C16 alkyl ether citrates (CAS 
Registration Number: 330985-58-5) 1,100 daltons
    [bull] C16-C18-alkyl ether citrates (CAS 
Registration Number: 330985-61-0) 1,300 daltons
    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.
    9. The polymers represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates 
have number-average molecular weights greater than 1,100 and contain 
less than 10% oligomeric material below molecular weight of 500 and 
less than 25% oligomeric material below 1,000 molecular weight.
    In addition, the monomers/reactants that are used for the 
production of polymers represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates 
have prior clearances by the Food and Drug Administration (FDA) under 
21 CFR for food contact applications, and by the Environmental 
Protection Agency under 40 CFR for use in pesticide formulations 
applied to raw agricultural commodities (RAC).
    1. Citric acid (CAS Registration Number: 77-92-9) was affirmed by 
FDA as generally recognized as safe (GRAS) under 21 CFR 184.1033 for 
use in food for human consumption.
    2. Citric acid (CAS Registration Number: 77-92-9) is cleared under 
40 CFR 180.1001(c) and (e) as an inert ingredient in pesticide 
formulations applied to RAC. It is included in Inerts - List 4A.
    3. Fatty alcohols are widely present in oils, fats and waxes which 
are used in human food. Some waxes (bees wax, candelilla wax and 
carnauba wax) are GRAS substances (21 CFR Part 184). Bees wax and 
carnauba wax are in Inerts - List 4B.
    4. C8-C18 Alcohols are List 3 inerts. 
Ethoxylated C10-C16 alcohols (CAS Registration 
Number: 68002-97-1) and ethoxylated C16-C18 
alcohols (CAS Registration Number: 68439-49-6) are included in Inerts - 
List 3. Ethoxylated C9-C16 alcohols (CAS 
Registration Number: 97043- 91-9) are in Inerts - List 4B.

C. Aggregate Exposure

    Although exposure to three polymers represented by [alpha]-hydro-
[]-hydroxy- 
poly(oxyethylene) C8-C18-alkyl ether citrates may 
occur through dietary sources, the chemical characteristics of these 
polymers lead to the conclusion that there is a reasonable certainty of 
no harm from aggregate exposure to these polymers.

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    The Agency has maintained that polymers meeting the polymer 
exemption criteria will present minimal risk to human health when used 
as inert ingredients in pesticide products applied to food crops. EPA 
has also established exemptions from tolerance for polymeric materials 
used as pesticide inert ingredients that it considers to be 
intrinsically safe based on the fact that they are listed on the TSCA 
Inventory or meet the requirements of the amended TSCA polymer 
exemption and are thereby not subject to the requirements of the pre-
manufacturing notification.
    Any exposure resulting from the approval of three polymers 
represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates in 
pesticide formulations for use on growing crops or to RAC after harvest 
is not warranted.

D. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by three polymers represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates 
having a number average molecular weight of at least 1,100 would be 
cumulative with those of any other chemical substance(s). Given the 
categorization of these polymers as a ``low risk polymer'' (40 CFR 
723.250) and their proposed use as inert ingredients in pesticide 
formulations, there is no reasonable expectation of increased risk due 
to cumulative exposure.

E. Safety Determination

    1. U.S. population. As a matter of policy, EPA has in the past 
established exemptions from tolerance for polymeric substances used as 
pesticide inert ingredients that it considers to be intrinsically safe 
based on the fact that they are listed on the TSCA Inventory or meet 
the requirements of the amended TSCA polymer exemption and are thereby 
not subject to the requirements of premanufacture notice (PMN). The 
Agency has maintained that polymers meeting the polymer exemption 
criteria will present minimal risk to human health when used as inert 
ingredients in pesticide formulations.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
supply an additional tenfold margin of safety for infants and children 
in the case of threshold effects where prenatal and/or postnatal 
toxicity are found or there is incompleteness of the database, unless 
EPA concludes that a different margin of safety will be safe for 
infants and children. Margins of safety are incorporated into EPA risk 
assessments either directly through the use of margin of exposure (MOE) 
analysis or through using uncertainty (safety) factors in calculating a 
dose level that poses no appreciable risk to humans.
    Due to the low expected toxicity of these three polymers 
represented by [alpha]-hydro-
[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates, a 
safety factor analysis is not required for assessing the risk. For the 
same reasons the additional safety factor is unnecessary.

F. International Tolerances

    Akzo Nobel Industrial Specialties, Inc. is not aware of any country 
requiring a tolerance for the three polymers represented by [alpha]-
hydro-[]-hydroxy-
poly(oxyethylene) C8-C18-alkyl ether citrates 
having a number average molecular weights of at least 1,100. Nor have 
there been any CODEX Maximum Residue Levels (MRLs) established for any 
food crops at this time.

[FR Doc. 02-30946 Filed 12-5-02; 8:45 am]
BILLING CODE 6560-50-S