Potassium Silicate; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 43417-43421 [05-14864]
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Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices
generic expected environment
concentration (GENEEC) and the ground
water model (SCI-GROW) were used to
determine whether drinking water from
surface or ground water sources
represented a worst-case exposure
scenario. These models predict residues
of flucarbazone-sodium would be higher
in surface water. Assuming a worst-case
GENEEC scenario where residues of
flucarbazone-sodium occur in surface
water used for drinking water at the
highest predicted acute and chronic
concentrations, the risk from exposure
to residues of flucarbazone-sodium are
well within EPA’s acceptable limits.
The GENEEC model predicted an
acute surface water concentration of
flucarbazone-sodium of 1.45 µg/L.
Assuming a 70 kilogram (kg) adult
drinks 2 liters/day containing 1.45 µg/L,
the acute exposure would be 0.0000414
mg/kg/day for adults. Assuming a 10 kg
child drinks 1 liter/day containing 1.45
µg/L, the exposure would be 0.000145
mg/kg/day. Based on the NOAEL of 300
mg/kg/day from the rabbit
developmental toxicity study and
assuming a safety of 100 (10x for
interaspecies variability and 10x for
interspecies extrapolation), the MOE for
adults of 72,500 and for children of
20,700 do not exceed EPA’s level of
concern for adults or children. This
assessment is based on the GENEEC
highest predicted acute concentration of
flucarbazone-sodium in drinking water
using worst-case assumptions.
Using GENEEC, the highest predicted
chronic (60–day exposure)
concentration of flucarbazone-sodium
was 1.44 µg/L. EPA interim policy
recommends that the 60–day GENEEC
value to be divided by an adjustment
factor of 3 to obtain a value for chronic
risk assessment calculations. Therefore,
a surface water value of 0.48 µg/L was
used for chronic risk assessment.
Assuming a 70 kg adult consumes 2
liters (L) of water per day containing
0.48 µg/L of flucarbazone-sodium
residues for a period of 70 years, less
than 0.004% of the RfD was consumed
from residues of flucarbazone-sodium in
surface water used for drinking water
(worst-case scenario). For a 10 kg child
drinking 1 L of water per day containing
0.48 µg/L of flucarbazone-sodium
residues, only 0.01% of the RfD was
consumed by drinking water.
2. Non-dietary exposure. There are no
current non-food uses for flucarbazonesodium registered under the Federal
Insecticide,Fungicide, and Rodenticide
Act (FIFRA), as amended. No non-food
uses are proposed for flucarbazonesodium. No non-dietary exposures are
expected for the general population.
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D. Cumulative Effects
Flucarbazone-sodium falls into the
category of sulfonamide herbicides.
There is no information to suggest that
any of this class of herbicides has a
common mechanism of mammalian
toxicity or even produce similar effects
so it is not appropriate to combine
exposures of flucarbazone-sodium with
other herbicides. Arvesta Corporation is
considering only the potential risk of
flucarbazone-sodium.
E. Safety Determination
1. U.S. population. As presented
previously, the exposure of the U.S.
general population to flucarbazonesodium is low, and the risks, based on
comparisons to the reference dose, are
minimal. The margins of safety from the
use of flucarbazone-sodium are well
within EPA’s acceptable limits. Arvesta
Corporation concludes that there is a
reasonable certainty that no harm will
result to the U.S. population from
aggregate exposure to flucarbazonesodium residues.
2. Infants and children. The complete
toxicological data base including the
developmental toxicity and 2–
generation reproduction studies were
considered in assessing the potential for
additional sensitivity of infants and
children to residues of flucarbazonesodium. The developmental toxicity
studies in rats and rabbits revealed no
increased sensitivity of rats or rabbits to
in-utero exposure to flucarbazonesodium. The 2–generation reproduction
study did not reveal any increased
sensitivity of rats to in-utero or
postnatal exposure to flucarbazonesodium. Furthermore, none of the other
toxicology studies revealed any data
demonstrating that young animals were
more sensitive to flucarbazone-sodium
than adult animals. The data taken
collectively clearly demonstrate that
application of a Food Quality Protection
Act (FQPA) uncertainty factor for
increased sensitivity of infants and
children is not necessary for
flucarbazone-sodium.
F. International Tolerances
A default Maximum Residue Limit
(MRL) of 0.01 ppm has been established
in Canada for residues of flucarbazonesodium and its N-desmethyl metabolite
on wheat grain. This value is consistent
with the tolerance being proposed in the
United States on wheat grain. There are
no harmonized MRLs at the European
Union level and no Codex MRLs for this
compound on wheat at present.
Therefore, no compatibility issues exist
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with Codex in regard to the proposed
U.S. tolerances.
[FR Doc. 05–14736 Filed 7–26–05; 8:45 am]
BILLING CODE 6560–50–S
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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:frazer.carol@epa.gov.
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
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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
https://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 https://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
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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.
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1. Electronically. If you submit an
electronic comment as prescribed in this
unit, EPA recommends that you include
your name, mailing address, and an email 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 https://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 opp-docket@epa.gov,
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.
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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
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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
Study
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
Guideline
Result
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.
Category
Acute oral
81–1
>5 g/kg
IV
Acute dermal
81–2
>5 g/kg
IV
Acute inhalation
81–3
>2.06 mg/Liter (L)
IV
Acute eye irritation
81–4
Score=12
III
Acute dermal irritation
81–5
Slight
IV
Acute dermal sensitization
81–6
Comments
Not Sensitizing
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
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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.
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.
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.
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
ENVIRONMENTAL PROTECTION
AGENCY
Orthosulfamuron; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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–
0207, 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.
19:40 Jul 26, 2005
Jkt 205001
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 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?
[OPP–2005–0207; FRL–7727–8]
VerDate jul<14>2003
Jim
Tompkins, Registration Division
(7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5697; e-mail address:
Tompkins.Jim@epa.gov.
FOR FURTHER INFORMATION CONTACT:
1. Docket. EPA has established an
official public docket for this action
under docket ID number OPP–2005–
0207. 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
43421
under the ‘‘Federal Register’’ listings at
https://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 https://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 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
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43417-43421]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14864]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:frazer.carol@epa.gov.
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 https://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 https://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 https://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 opp-docket@epa.gov,
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.
[[Page 43419]]
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.
[[Page 43420]]
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.
----------------------------------------------------------------------------------------------------------------
Study Guideline Result Category Comments
----------------------------------------------------------------------------------------------------------------
Acute oral 81-1 >5 g/kg IV ..................
----------------------------------------------------------------------------------------------------------------
Acute dermal 81-2 >5 g/kg IV ..................
----------------------------------------------------------------------------------------------------------------
Acute inhalation 81-3 >2.06 mg/Liter (L) IV ..................
----------------------------------------------------------------------------------------------------------------
Acute eye irritation 81-4 Score=12 III ..................
----------------------------------------------------------------------------------------------------------------
Acute dermal irritation 81-5 Slight IV Clears in 72 hours
----------------------------------------------------------------------------------------------------------------
Acute dermal sensitization 81-6 Not Sensitizing ..................
----------------------------------------------------------------------------------------------------------------
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
[[Page 43421]]
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
