[Federal Register Volume 69, Number 249 (Wednesday, December 29, 2004)]
[Notices]
[Pages 78017-78020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28499]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0241; FRL-7193-8]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora 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-2002-0241, must be 
received on or before January 28, 2005.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket ID 
number OPP-2002-0241 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: Raderrio Wilkins, Biopesticides and 
Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-1259; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this Action Apply to Me?

     You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     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 the unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Infomation?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2004-0241. 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

[[Page 78018]]

2, 1801 S. Bell St., 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-2004-0241. 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-2004-0241. 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-2004-0241.
    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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2004-0241. 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

[[Page 78019]]

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 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: December 15, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

 Summary of Petition

     The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by Environmentally Safe Systems, Inc. and 
represents the view of Environmentally Safe Systems, Inc. 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.

 Environmentally Safe Systems, Inc.

 PP 2E6381

     EPA has received a pesticide petition [2E6381] from Interregional 
Research Project Project Number 4 (IR-4), Technology Centre of New 
Jersey, Rutgers University, 681 U.S. Highway 1 South, New 
Brunswick, NJ 08902-3390, 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 sodium metasilicate in or on all food commodities.
     Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Environmentally Safe Systems, Inc. has submitted the following summary 
of information, data, and arguments in support of their pesticide 
petition. 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

     Sodium metasilicate, the active ingredient in the end use product 
known as TRIAD, when used as a foliar spray controls or suppresses 
mealybugs and leafhoppers. It also suppresses powdery mildew. 
Applications of TRIAD are made at 11/89/21/13/23/85/83/8 to 
41/89/21/13/23/85/83/8 gallons per 100 gallons beginning as 
soon as possible after the pest is observed and repeated at 14- to 21-
day intervals as needed.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Sodium 
metasilicate is mixed with other ingredients to prepare the end use 
product known as TRIAD, which contains 2.41% sodium metasilicate.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. This section is not applicable, as this proposes 
an exemption from the requirement of a tolerance.
    3. A statement of why an analytical method for detecting and 
measuring the levels of the pesticide residue are not needed. An 
analytical method for residues is not applicable, as this proposes an 
exemption from the requirement of a tolerance.

C. Mammalian Toxicological Profile

     Sodium metasilicate is not very toxic via the oral route. Sodium 
metasilicate has an acute oral LD50 of 1,153 milligrams/
kilogram (mg/kg) in rats and 770 mg/kg in mice. Primary skin irritation 
and primary eye irritation tests, as well as acute inhalation and acute 
oral toxicity tests on an end use formulation containing 2.41% sodium 
metasilicate have been submitted to EPA. Sodium metasilicate when used 
as a plant desiccant (not to exceed 4% by weight in aqueous solution) 
is considered safe (40 CFR 180.2). Sodium metasilicate is classified as 
a generally recognized as safe (GRAS) substance and is cleared as a 
direct food ingredient. Residues of sodium metasilicate are exempted 
from the requirement of a tolerance when used as a surfactant, 
emulsifier, wetting agent, suspending agent, dispersing agent, or 
buffer in accordance with good agricultural practices as inert (or 
occasionally active) ingredients in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest (40 CFR 
180.1001(c)).

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Currently, dietary exposure to sodium 
metasilicate occurs primarily from its use as a direct food additive 
(21 CFR 184.1769a). Sodium metasilicate is used in many other products 
such as dishwashing soaps, other soaps and detergents. Dietary exposure 
to residues of sodium metasilicate as a result of uses covered under 
this tolerance

[[Page 78020]]

exemption is expected not to be significant.
    ii. Drinking water. Sodium metasilicate residues in drinking water 
from use as a pesticide are expected to be minimal when compared to the 
ubiquity of naturally occurring forms of silicon dioxide in the 
environment and the widespread use of sodium metasilicate in 
dishwashing soaps, other soaps and detergents, etc. Because of the gel-
forming properties of sodium metasilicate, leaching from the soil is 
very unlikely. In fact, sodium metasilicate is used for soil 
stabilization.
    2. Non-dietary exposure. There may be non-dietary exposure to 
sodium metasilicate from non-pesticidal uses of sodium metasilicate, 
but significantly increased non-dietary exposure and non-occupational 
exposure from sodium metasilicate when used as a pesticide is not 
expected.

E. Cumulative Exposure

     Because of the low oral toxicity of sodium metasilicate and 
because of the fact that its presence in the diet is, for the most 
part, as a direct food additive, no cumulative mode of exposure is 
expected for sodium metasilicate.

F. Safety Determination

    1. U.S. population. Based on its low toxicity, there is reasonable 
certainty that no harm will result from aggregate exposure of the U.S. 
population, including infants and children, to residues of sodium 
metasilicate. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. There is an 
inconsequential increase in dietary exposure resulting from application 
as a pesticide.
    2. Infants and children. Based on the low toxicity of sodium 
metasilicate, there is a reasonable certainty that no harm to children 
or adults will result from aggregate exposure to sodium metasilicate. 
Exempting sodium metasilicate from the requirement of a tolerance 
should pose no significant risk to humans.

G. Effects on the Immune and Endocrine Systems

     To date there is no evidence to suggest that sodium metasilicate 
functions in a manner similar to any known hormone, or that it acts as 
an endocrine disruptor.

H. Existing Tolerances

     There are no existing tolerances for sodium metasilicate in the 
United States.

I. International Tolerances

     There are no known approved codex maximum residue levels 
established for residues of sodium metasilicate.
[FR Doc. 04-28499 Filed 12-28-04; 8:45 am]
BILLING CODE 6560-50-S