[Federal Register Volume 69, Number 34 (Friday, February 20, 2004)]
[Notices]
[Pages 7949-7953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3719]


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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: [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:
     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 [email protected], 
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

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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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