[Federal Register Volume 68, Number 237 (Wednesday, December 10, 2003)]
[Notices]
[Pages 68908-68911]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30522]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2003-0362; FRL-7335-5]


Alkyl (C10-C16) Polyglycosides; 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-2003-0362, must be 
received on or before January 9, 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: James Parker, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0731; 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

[[Page 68909]]

producer, food manufacturer or pesticide manufacturer. Potentially 
affected entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 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-2003-0362. 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 on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2003-0362. 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-2003-0362. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access''

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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-2003-0362.
    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-2003-0362. 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 record 
keeping requirements.

    Dated: November 21, 2003.
Susan Lewis,
Acting Director, Registration 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 Cognis Corporation and represents the view of the 
petitioner. The summary may have been edited by the 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. 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.

 Cognis Corporation

 PP 4E4332

     EPA has received a pesticide petition (PP 4E4332) from Cognis 
Corporation, 4900 Este Avenue, Cincinnati, OH 45232 proposing, pursuant 
to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a(d), to amend 40 CFR part 180, by establishing a 
tolerance exemption for residues of alkyl (C10-
C16) polyglycosides (CAS Reg. No. 110615-47-9) when used as 
an inert ingredient in a pesticide product. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolis. No plant metabolism studies have been submitted 
in support of this petition since an exemption from tolerance is being 
requested. In addition, alkyl (C10-16) polyglycosides are 
expected to rapidly degrade to sugars and fatty alcohols in treated 
plants.
    2. Analytical method. Since the petitioner has requested a 
tolerance exemption, a residue analytical method for alkyl 
(C10-16) polyglycosides in food crops is not required.
    3. Magnitude of residues. Due to the very low toxicity exhibited by 
the alkyl polyglycosides, in either acute or sub-chronic studies, and 
the rapid metabolism of these substances to sugars and fatty alcohols, 
no field residue studies were conducted.

B. Toxicological Profile

    1. Acute toxicity. Based on acute studies conducted with alkyl 
(C12-14) polyglycosides, the acute toxicity of alkyl 
(C10-16) polyglycosides is expected to be of a very low 
order. The acute oral LD50 for alkyl (C12-14) 
polyglycosides is

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greater than 5 gram/kilogram (g/kg) body weight and the acute dermal 
LD50 is greater than 2 g/kg body weight. Concentrations of 
less than 30% alkyl (C12-14) polyglycosides are non-
irritating to skin. Alkyl (C12-14) polyglycosides are not 
dermal sensitizers.
    2. Genotoxicty. Based on studies conducted with alkyl 
(C12-14) polyglycosides, alkyl (C10-16) 
polyglycosides are considered non-mutagenic. In the bacterial gene 
mutation study (Ames test), alkyl (C12-14) polyglycosides 
did not cause an increase in revertants, compared to controls, with or 
without metabolic activation. In the in-vitro cytogenetic study, alkyl 
(C12-14) polyglycosides did not cause an increase in 
chromosomal aberrations, compared to controls, with or without 
metabolic activation.
    3. Reproductive and developmental toxicity. In a developmental 
toxicity study, test animals were treated with alkyl 
(C12-14) polyglycosides, by gavage, on days 6 through 15 of 
gestation at doses of 0, 100, 300 and 1,000 mg/kg body weight. There 
were no maternal or fetal effects noted in any of the test groups. 
Based on this study, both the maternal and developmental no observed 
effect level (NOEL) for alkyl (C12-14) polyglycosides is 
greater than 1,000 milligrams/kilogram (mg/kg) body weight.
    4. Subchronic toxicity. In a sub-chronic (90-day) feeding study, 
test animals were treated with alkyl (C12-14) polyglycosides 
at doses of 0, 250, 500 and 1,000 mg/kg body weight. The only adverse 
effect observed in the study, in the mid (500 mg/kg) and high dose 
(1,000 mg/kg) groups, was reversible dose-dependent irritation and 
ulceration of the mucous membranes of the forestomach. Based on this 
study, the no observed adverse effect level (NOAEL) is 1,000 mg/kg body 
weight and the NOEL is 250 mg/kg/body.
    5. Animal metabolism. Metabolism studies conducted in the mouse 
with closely related alkyl polyglycosides show that the -glycosidic 
bond of the alkyl polyglycosides is rapidly hydrolyzed in the intestine 
and liver. The degradates are sugars and long-chain alcohols, which 
then undergo carbohydrate and lipid metabolism.
    6. Metabolite toxicology. The metabolites of alkyl 
(C10-16) polyglycosides are glucose and fatty alcohols, 
neither of which present any toxicity concerns.
    7. Endocrine disruption. There is no information from studies 
conducted by the Cognis Corporation nor from the published literature 
which associates the alkyl polyglycosides with endocrine disruption.

C. Aggregate Exposure

    1. Dietary exposure. A dietary exposure assessment for alkyl (C10-
16) polyglycosides has not been conducted because the alkyl 
polyglycosides, as a class of compounds, do not present any 
toxicological effects of concern. In addition, alkyl 
(C10-16)polyglycosides are expected to be rapidly degraded 
to glucose and fatty alcohols.
    i. Food. Crop levels of alkyl (C10-16) polyglycosides have not been 
determined since a tolerance exemption is being requested. Moreover, 
even if residues of alkyl (C10-16) polyglycosides do occur 
on food crops these residues are of little concern since the alkyl 
polyglycosides are practically non-toxic.
    ii. Drinking water. Minimal, if any, residues of alkyl 
(C10-16) polyglycosides are expected to occur in drinking 
water since alkyl polyglycosides should be rapidly (and completely) 
biodegraded in soils.
    2. Non-dietary exposure. Non-dietary (residential) exposure to 
alkyl (C10-16) polyglycosides from the use of this substance 
as an inert ingredient in pesticide products is anticipated to be 
insignificant since only short-term exposure will be involved and 
dermal absorption through the skin is expected to be minimal.

D. Cumulative Effects

     No cumulative adverse effects are expected from long-term exposure 
to alkyl (C10-16) polyglycosides since the only affect 
observed in the safety studies conducted with the alkyl polyglycosides 
was localized irritation.

E. Safety Determination

    1. U.S. population. The safety studies performed with the alkyl 
polyglycosides clearly demonstrate that this class of compounds are 
practically non-toxic. The only adverse effect observed in any of the 
studies conducted with the alkyl polyglycosides was localized, 
reversible irritation of the forestomach in the sub-chronic feeding 
study. Consequently, the use of the alkyl (C10-16) 
polyglycosides as an inert ingredient in pesticidal formulations 
applied to growing crops is not anticipated to result in any adverse 
effects.
    2. Infants and children. There is no evidence from the safety 
studies sponsored by Cognis, particularly the developmental toxicity 
study, nor from the published literature of any unique susceptibilities 
of infants and/or children to alkyl polyglycoside exposure. Based on 
the extremely low toxicity of the alkyl polyglycosides no adverse 
effects on infants and/or children from the use of alkyl 
(C10-16) polyglycosides as an inert ingredient in pesticidal 
formulations applied to growing crops is anticipated.

F. International Tolerances

     There are no approved CODEX maximum residue levels (MRLs) 
established for residues of alkyl (C10-16) polyglycosides.
[FR Doc. 03-30522 Filed 12-9-03; 8:45 am]
BILLING CODE 6560-50-S