[Federal Register: December 6, 2002 (Volume 67, Number 235)]
[Notices]
[Page 72675-72678]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de02-72]
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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: gandhi.bipin@epa.gov.
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-
[[Page 72676]]
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 opp-docket@epa.gov,
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.
[[Page 72678]]
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]
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