[Federal Register: February 20, 2004 (Volume 69, Number 34)]
[Notices]
[Page 7949-7953]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe04-47]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2004-0016; FRL-7343-3]
Ethoxy Dodecyl Phenol; Notice of Filing a Pesticide Petition to
Establish a Tolerance for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2004-0016, must be received on or before March 22, 2004.
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: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-9525; e-mail
address: benmhend.driss@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, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2004-0016. 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
[[Page 7950]]
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 EPA's 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.1. 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-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-2004-0016. 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-2004-0016. 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-2004-0016.
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-2004-0016. 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
[[Page 7951]]
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: February 5, 2004.
Sheryl K. Reilly,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by 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.
Cal Agri Products, LLC
PP 3F6778
EPA has received a pesticide petition 3F6778 from Cal Agri
Products, LLC, 10720 McCune Avenue, Los Angeles, CA 90034, proposing
pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40
CFR part 180 to establish an exemption from the requirement of a
tolerance for the biochemical pesticide ethoxy dodecyl phenol in or on
growing crops and raw agricultural commodities.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Cal
Agri Products, LLC has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This
summary was prepared by Cal Agri Products, LLC and EPA has not fully
evaluated the merits of the pesticide petition. The summary may have
been edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary unintentionally made the
reader conclude that the findings reflected EPA's position and not the
position of the petitioner.
A. Product Name and Proposed Use Practices
Cal Agri Products, LLC (CAP) has filed a petition for the exemption
from the requirement of tolerance for residues in growing crops and raw
agricultural foods for ethoxy dodecyl phenol (EDP), when used as a
pesticide active ingredient. EDP is a common component in industrial
and consumer products with considerable data demonstrating its safety
for use in and around foods (21 CFR 178.3400). EDP is also a common
inert ingredient in agricultural pesticides and has been categorized by
EPA as a List 4B inert ingredient, identifying it as a compound of
minimal toxicological concern. EDP is also currently listed under 40
CFR 180.1001(c) and (e) and 21 CFR 172.710 as exempt from the
requirement of a food tolerance when used as an inert ingredient or
occasionally as an active ingredient. EDP is formulated as a pesticide
active ingredient and has been shown to operate as an effective non-
toxic control agent of a number of agriculturally important insect
pests and pathogens. The formulation utilizing EDP operates through a
non-toxic, physical mode of action that effects the insects' protective
coating making them more vulnerable to desiccation from a secondary
formulation ingredient. Extensive field trials have shown this
formulation to be commercially effective against a number of soft-
bodied insect pests and a potential substitute for more toxic
pesticides such as the organophosphates which remain the primary
pesticides used against some of these pests. The formulation is
intended for use primarily against soft-bodied insect pests, such as
aphids and whiteflies, and foliar pathogens, such as powdery mildew.
Proposed uses include foliar applications to food and non-food crops
and soil applications for the control of soil dwelling pests and
pathogens. The formulation will be diluted with water for use at a rate
of 2,000 to 4,000 parts per million (ppm) (600 to 1,200 ppm of EDP).
Use patterns will include application on field and greenhouse grown
food crops and on ornamental and nursery crops.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Ethoxy
dodecyl phenol (CAS No. 9014-92-0) is in the ethoxylated alkyl phenol
chemical family (alpha-(p-dodecylphenyl)-omega-hydroxypoly
(oxyethylene) and described by the empirical formula
C18H25-C6H4-
O(CH2CH2O)7CH2CH2
OH. EDP is produced by adding an alpha-olefin to a phenol molecule
resulting in an alkyl phenol, which is subsequently ethoxylated by
adding ethylene oxide. EDP is commercially available as a viscous clear
liquid and is a common surfactant used in many products as a wetting
agent, antifoaming agent,
[[Page 7952]]
detergent, dispersant, or emulsifier. EDP is listed as an inert
ingredient of minimal concern (List 4B) by EPA and is exempt from the
requirement of a food tolerance (40 CFR 180.1001(c) and (e)) when used
as an inert (or occasionally active) ingredient in pesticide
formulations. Furthermore, EDP is approved for use as an indirect food
additive (21 CFR 178.3400).
2. Magnitude of residue at the time of harvest and method used to
determine the residue. At harvest time, residues of EDP are projected
to be negligible because this compound degrades rapidly in aerobic
environments and even more rapidly when sunlight is present, due to
photodegradation of the phenolic ring. Moreover, EDP is an approved
food additive established by the Food and Drug Administration (FDA)
under 21 CFR 172.710, which permits its use in and around the use of
foods, such as a component of food packaging material.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. EPA in
granting an exemption from tolerance for EDP as an inert ingredient has
previously determined that no harm will result from aggregate exposure
to EDP when used as an inert ingredient in pesticide formulations.
Therefore, no analytic method for detecting residues have been
required.
C. Mammalian Toxicological Profile
Ethoxyl dodecyl phenol (synonym: dodecyl phenol ethoxylate) and
other very similar alkylphenol ethoxylates (APEs) (e.g., octylphenol
ethoxylate and nonylphenol ethoxylates) are common inert ingredients in
many pesticide products in the United States and other nations. In
1995, EPA concluded that the current use patterns of EDP in pesticide
products will not adversely affect public health or the environment and
reclassified EDP from the list of inert ingredients of unknown toxicity
(List 3) to its current classification of minimal risk inert
ingredients (List 4B). EDP is also exempt from the requirement of food
tolerances by EPA under 40 CFR 180.1001(c) and (e) when used in
accordance with good agricultural practice as an inert and occasionally
as an active ingredient in pesticide formulations when applied to
growing crops or to raw agricultural commodities after harvest.
1. Acute toxicity. EDP has been studied extensively in animal
testing. Studies have demonstrated an acute oral toxicity, lethal dose
(LD)50 = 2,590 milligrams/kilogram (mg/kg) and 3,300 mg/kg
in rats (toxicity category III) and an acute dermal toxicity of
LD50 = 1,260 mg/kg and 5,000 mg/kg in rabbits (toxicity
category III). Occular exposure in rabbits yielded moderate eye
irritation at 100 [mu]L/24 hours. Dermal testing in rabbits determined
EDP is a primary dermal irritant. Dermal patch tests in humans produced
no positive reactions after 15 repeated applications.
2. Genotoxicity. There is no evidence of genotoxicity from exposure
to EDP. APEs, such as EDP, as a surfactant group are considered non-
genotoxic based on a wide variety of in vivo and in vitro tests.
3. Developmental toxicity and teratogenicity. There is no evidence
of reproductive or developmental toxicity from exposure to EDP. No
effects on reproduction or teratogenicity were found in studies testing
daily consumption of EDP at a rate between 50 and 100 mg/kg/day. Acute
studies demonstrated no teratogenic effects at doses below 500 mg/kg.
4. Subchronic toxicity. Animal studies have demonstrated that daily
doses of EDP over 90 days at 100 mg/kg/day resulted in no toxicological
effects. Results indicated that the risk of subchronic effects are
minimal, particularly from ``low-dose'' exposure.
5. Chronic toxicity. There is no evidence of chronic toxicity from
exposure to EDP. EDP's low mammalian toxicity and the lack of any
reported negative effects by producers and consumers of EDP, indicate
that chronic toxicity at the proposed rates of use would pose minimal
concern.
6. Animal metabolism. EDP is quickly metabolized and excreted in
mammals. No effect on metabolism has been noted, except at very high
exposure levels. Further, EDP's low mammalian toxicity and the lack of
reported effects by users of EDP in a variety of pesticide and consumer
products indicate metabolic effects would be unlikely at the proposed
use rates.
7. Metabolite toxicology. No evidence of metabolite toxicity in
mammals from exposure to EDP has been found or suspected. Based on the
low mammalian toxicity of EDP and the lack of reported effects by users
of EDP in a variety of pesticide and consumer products suggests that
metabolite toxicity would be unlikely at proposed use rates.
8. Endocrine disruption. No evidence of endocrine disruption from
EDP has been indicated, except at high exposure levels. EDP's low
mammalian toxicity and the lack of reported effects by users of EDP in
a variety of pesticide and consumer products indicate EDP would be of
minimal concern at the proposed use rates.
D. Aggregate Exposure
1. Dietary exposure--i. Food. EDP is an approved food additive
established by the FDA under 21 CFR 172.710, which permits its use in
and around the use of foods, such as a component of food packaging
material. Use of EDP on food crops is unlikely to enhance consumer
exposure given its wide-spread use in consumer products, its rapid
biodegradability and the low end-use concentrations when applied to
plants as a pesticide at the proposed use rates.
ii. Drinking water. There is no significant human exposure to EDP
in drinking water due to the small amounts and low proposed use rates
in the pesticide formulation. Additionally, EDP is rapidly degraded in
aerobic environments and even more rapidly when sunlight is present,
due to photodegradation of the phenolic ring.
2. Non-dietary exposure. EDP and other APEs are high production
chemicals found in many food and consumer cleaning products. As a
result there are numerous routes of non-dietary exposure. The
relatively small amount of EDP contained in the pesticide formulation
and its limited use (crop protection) is unlikely to influence non-
dietary exposure to children or other consumer groups.
E. Cumulative Exposure
EDP and other APEs are high production chemicals found in many food
and consumer cleaning products. Due to the low concentrations of EDP
used in the pesticide formulation and the rapid degradation of EDP in
the environment, EDP presents a minimal risk for cumulative effects in
humans or in the environment.
F. Safety Determination
1. U.S. population. Research and practical experience using EDP in
consumer products have resulted in no reports of adverse effects to
human health or the environment. Given the relatively low concentration
of EDP in the pesticide formulation and its rapid degradation when
applied to crops, there is every reason to believe that no additional
risk to the U.S. population will result from aggregate exposure to EDP.
2. Infants and children. Given the low-risk profile of EDP, its'
widespread use in consumer products and the relatively low
concentration of EDP in the proposed pesticide formulation when applied
to food crops, EDP is unlikely to pose additional risks to infants and
children. In addition, substitution of the pesticide formulation
[[Page 7953]]
containing EDP in place of more toxic pesticides, such as
organophosphates, may reduce infants and children's overall exposure to
residual toxins in and on foods.
G. Effects on the Immune and Endocrine Systems
No evidence of immune or endocrine effects from EDP in mammals have
been found or suspected, based on its low mammalian toxicity and the
lack of reported effects by users of EDP in a variety of pesticide and
consumer products.
H. Existing Tolerances
EDP is listed as exempt from the requirement of a tolerance under
40 CFR 180.1001 (c) and (e) and 21 CFR 172.710 when used as an inert
ingredient in pesticide formulations. EDP is also approved for use as
an indirect food additive under 21 CFR 178.3400.
I. International Tolerances
There are no known Codex maximum residue levels established for
EDP.Archives of Environmental Contamination and Toxicology 26: 540-548.
[FR Doc. 04-3719 Filed 2-19-04; 8:45 am]
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