[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43417-43421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14864]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0166; FRL-7719-5]
Potassium Silicate; 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-
2005-0166, must be received on or before August 26, 2005.
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: Carol E. Frazer, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8810; 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 an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected 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 this unit could also be
affected. The North American
[[Page 43418]]
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-2005-0166. 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, 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.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-2005-0166. 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-2005-0166. 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.
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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-2005-0166.
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-2005-0166. 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 assignedto this action in the subject line on the first page
of your response. You may also provide thename, 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: July 11, 2005.
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 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.
PQ Corporation
PP 5F6905
EPA has received a pesticide petition 5F6905 from PQ Corporation,
P.O. Box 840 Valley Forge, PA 19482-0840 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 to establish an exemption from the
requirement of a tolerance for the biochemical pesticide potassium salt
of silicic acid (potassium silicate).
Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, PQ
Corporation has submitted the following summary of information, data,
and arguments in support of their pesticide petition. This summary was
prepared by PQ Corporation 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
The new active ingredient proposed in this petition is potassium
silicate. The products formulated from this active ingredient will be
sold under the product name Agsil. Potassium silicate is the potassium
salt form of silicic acid. Dilute aqueous solutions of potassium
silicate (about 1% or less when tank mixed), will be applied to fruit
crops, nuts, vegetable crops, and vine crops, and as a fungicidal
pesticide (against such diseases as powdery mildew) and as an
insecticide (for use against the pests such as spider mites and
whiteflies).
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues.After
aqueous formulating, potassium silicate consists of potassium and
silicic acid (Si(OH)4).
2. Magnitude of residue at the time of harvest and method used to
determine the residue. In plants Si(OH)4 is rapidly absorbed
and enhances growth and plant vigor. Currently potassium silicates are
sold as fertilizer. Once absorbed, silicic acid is readily circulated
throughout the plant and deposited as silicon dioxide.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. The
primary function of silicon in plants is to enhance the absorption and
translocation of macro and micro nutrients. The primary benefit of
silicon is the even distribution of these nutrients through the plant,
enhancing overall total plant vigor. Silicon also enhances plant
structural strength by increasing rigidity within cell walls.
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This also enhances plant thriving and vigor.
Since both potassium and silicic acid are rapidly absorbed and
utilized by plants, it is not possible to detect residues of potassium
silicate applied as an insecticide essentially 24 hours after
application. Silicates such as potassium silicate are not discernable
from silicates found ubiquitously within crops and the environment in
general. Further given the significant percentage of crop tissues that
contain silicon dioxide, it is unlikely that any significant increase
in silica concentration due to silicate pesticide applications would
occur.
C. Mammalian Toxicological Profile
Solutions of sodium silicate are used for corrosion control in
potable water as allowed by the EPA. Potassium silicate is Generally
Regarded as Safe (GRAS) by the Food and Drug Adminsitration (FDA).
Silica is naturally present in municipal drinking water at about 8
parts per million (ppm). Because of their ubiquitous distribution in
water, soil and plant, and animal tissue, they are consumed on a daily
basis. The FDA has determined that potassium silicate is identical in
chemical properties to sodium silicate. Sodium metasilicate (sodium
silicate with a SiO2/Na2O weight ratio of 1:1)
and sodium silicate are currently exempt from the requirement of a
tolerance on crops (40 CFR 180.1001 (c)).
1. Acute toxicity. Neither sodium nor potassium silicate are orally
toxic. Studies on both substances in Europe have found the
LD50 to exceed 2,000 milligram/kilogram (mg/kg). The World
Health Organization puts the oral LD50 in rats for silicic
acid at 3.16 gram/kilogram (g/kg) body weight and for mice at >5 gram/
kg body weight. Several studies on various concentrations of sodium
silicate found LD50 values ranging from 1,300 mg/kg to
>10,000 mg/kg. The estimated LD50 dose for silicic acid for
man is >15 g/kg body weight. The estimated LD50 for a
solution of sodium silicate (and therefore potassium silicate) is
estimated between 0.5 and 5.0 g/kg body weight with toxicity due more
to the higher alkalinity of the solution.
Potassium silicate will be applied to crops in dilute solutions.
The end use products will contain 29% potassium silicate or less. The
applications solutions will contain less than 1% potassium silicate. A
full acute toxicology battery has been completed on a 29% w/w aqueous
potassium silicate solution. The results of those studies are tabulated
in the table in this unit.
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Study Guideline Result Category Comments
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Acute oral 81-1 >5 g/kg IV ..................
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Acute dermal 81-2 >5 g/kg IV ..................
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Acute inhalation 81-3 >2.06 mg/Liter (L) IV ..................
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Acute eye irritation 81-4 Score=12 III ..................
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Acute dermal irritation 81-5 Slight IV Clears in 72 hours
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Acute dermal sensitization 81-6 Not Sensitizing ..................
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2. Genotoxicity.DNA damage and repair assay and reverse mutation
assays conducted on sodium silicate were negative for genotoxic
effects. A 2-year chronic toxicity study was negative for
carcinogenicity.
3. Reproductive and developmental toxicity. A 1-generation rat
reproduction study with the oral administration of 790 ppm and 1,580
ppm sodium silicate (equivalent to 600 ppm and 1,200 ppm silicon
dioxide) was conducted for 180 days. No adverse effects were noted. A
2-generation reproduction study with the oral administration of 100 mg/
kg body weight (bw) per day amorphous silica to rats was also
conducted. The parent generation (one male and five females) produced
five litters with a total of 25 rats. Half a year later, one male and
five females of the first generation were mated; the number of animals
in the second generation was 21. Neither malformation nor any other
adverse effects were noted. In summary, no chronic detrimental effects
were noted for intake of silicates. In fact positive nutritional
aspects were noted in most of the studies.
4. Animal metabolism. Some amount of silica is normally present in
all body tissues. Silicic acid is a normal constituent of urine with
excreted values ranging from 10-30 mg/day. The silica content of human
tissue varies from 10-200 mg/100 g dry weight.
D. Aggregate Exposure
1. Dietary exposure--i. Silicic acid salts are the most common form
of silicon. Silicon is a nutritional trace element required for proper
and strong growth of mammalian bones. In plants, silicic acid
(Si(OH)4) is rapidly absorbed. Once absorbed, silicic acid
is readily circulated throughout the plant and deposited as silicon
dioxide. Consequently, exposure to soluble silica occurs on a daily
basis and is a property of all plant products in human diet. The
concentration of silicon in vegetable plants varies greatly with
cereals and grasses containing the highest concentrations (0.2-2.0%).
Further, silica is approved by the FDA for use as an anti-caking agent
in food.
ii. Drinking water. Silicate is used as a corrosion inhibitor for
potable water. The use rate for municipal water supplies is 8 ppm.
2. Non-dietary exposure. Silicon comprises 31% of the Earth's
crust. Silicic acid salts (silicates) are the most common form of
silicon. Consequently, exposure to silicates is widespread in
activities involving contact with soil and natural water.
E. Safety Determination for U.S. population, Infants and Children
Section 408 of FFDCA provides that EPA shall apply an additional
tenfold margin of exposure (MOE) for infants and children in the case
of threshold effects to account for pre- and post-natal toxicity and
the completeness of the database, unless EPA determines that a
different MOE will be safe for infants and children.
MOEs are often referred to as uncertainty (safety) factors. In this
instance, the Agency believes that there are reliable data to support
the conclusion that the subject active ingredient when used as a
systemic acquired resistence (SAR) inducer, are practically non-toxic
to mammals, including infants and children, and, thus, there are no
threshold effects, and EPA has not used a MOE approach to assess their
safety. As a result, the provision requiring an additional MOE does not
apply. Consistent with FFDCA
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section 408(b)(2)(D), EPA has reviewed the available scientific data
and other relevant information in support of this action. Based on the
information and data considered, the Agency has determined that use of
this pesticide as a SAR inducer will not pose a dietary risk under
reasonably foreseeable circumstances.
Accordingly, EPA concludes that, in amending 40 CFR part 180, to
establish the exemptions as proposed, there is a reasonable certainty
that no harm to the general population, including infants and children,
will result from aggregate exposure to the pesticide chemical residues
of the subject active ingredient, when used as a SAR inducer. The
safety of infants and children is supported by oral toxicity data
indicating that, for the subject active ingredient, the doses must
exceed 5,000 mg/kg before toxicity occurs.
F. Endocrine Disruption
The Agency has no information that suggests silicates will have an
effect on the immune or endocrine system. Given the widespread presence
of natural silicates such effects are highly unlikely.
G. International Tolerances
There are no CODEX, national or international, tolerance exemptions
established for the subject active ingredient at this time.
[FR Doc. 05-14864 Filed 7-26-05; 8:45 am]
BILLING CODE 6560-50-S