Potassium Silicate; Exemption from the Requirement of a Tolerance
[Federal Register: June 14, 2006 (Volume 71, Number 114)]
[Rules and Regulations]
[Page 34267-34272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn06-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0299; FRL-8069-6]
Potassium Silicate; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of potassium silicate in or on all food
commodities when applied/used as a fungicide, insecticide or miticide
so long as the potassium silicate is not applied at rates exceeding 1%
by weight in aqueous solution and when used in accordance with good
agricultural practices. PQ Corporation submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of potassium
silicate.
DATES: This regulation is effective June 14, 2006. Objections and
requests for hearings must be received on or before August 14, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0299. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are available
in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
for the Docket is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Carol E. Frazer, Biopesticides and
Pollution Prevention Division (7511P), 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 are 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 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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal Register
document through the electronic docket at http://www.regulations.gov,
you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at
http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by the FQPA, any person
may file an objection to any aspect of this regulation and may also
request a hearing on those objections. The EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. You must file your objection or request a
hearing on this regulation in accordance with the instructions
[[Page 34268]]
provided in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2006-0299 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August
14, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0299, by one of the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
telephone number for the Docket is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of July 27, 2005 (70 FR 43417) (FRL-7719-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5F6905) by PQ Corporation, P.O. Box 840 Valley Forge, PA
19482-0840. The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of potassium silicate. This notice included a summary of
the petition prepared by the petitioner PQ Corporation. There were no
comments received in response to the notice of filing.
Section 408(c)(2)(A)(I) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
Potassium silicate is a synthetic compound that is chemically the
potassium salt of silicic acid. It is produced by combining pure silica
sand (SiO2) and potash (K2CO3 or
NaCO3). Silicic acid salts (i.e., silicates) are the most
common form of silicon. For the purposes of this tolerance exemption,
the Agency has relied on the extensive body of knowledge, data and/or
information from the public literature as submitted by PQ Corporation
and as researched by the Agency which document the similarity of silica
(also known as silicon dioxide) and potassium silicate and support the
conclusion that there is reasonable certainty of no harm that will
result from the use of potassium silicate as an agricultural pesticide.
Silicon dioxide (silica) has been assessed for its pesticidal uses
by the Agency and it was determined that the toxicity of this compound
is moderate to low and therefore, the human health risk is low and not
unreasonable. Further, silicon dioxide is recognized by the Food and
Drug Administration (FDA) to be a Generally-Recognized As Safe (GRAS)
substance, as a food additive (21 CFR 182.90 and 182.1711).
Comprehensive reviews and risk assessments have been conducted on
silicon dioxide (silica) and its related soluble silicates with regard
to its toxicity to human health and have concluded that silica and its
soluble silicates (potassium silicate) are low in toxicity and the
primary hazard of concern is the corrosive nature of the compound. The
corrosive nature of potassium silicate is not of a concern when used as
a very dilute solution (less than or equal to 1%). The soluble
silicates include: potassium silicate, sodium silicate and sodium
metasilicate, the latter of which the Agency has exempted in diluted
form from the requirement of a tolerance for use on all food
commodities. Additionally, the FDA has determined that sodium silicate
and potassium silicate can be used interchangeably which substantiates
information in the public literature that the compounds are very similar.
The data submitted and reviewed on the end use pesticide product
containing 29.1% w/w potassium silicate caused moderate to low dermal
irritation and is classified as an eye irritant due to the high pH of
the product. When used as a pesticide (fungicide, insecticide and
miticide) the active ingredient is effective at very low concentrations
(less than or equal to 1%) and thus the dilution of the active
ingredient would reduce the risks to pesticide users. Labeling of such
products with the appropriate protective clothing, gloves and eyewear
would mitigate the risk of exposure to potassium silicate on pesticide
applicators. Potassium silicate residues which may result from its use
as an agricultural pesticide would be reduced by washing or processing
treated commodities before their consumption; this point is supported
by the water solubility of potassium silicate and the possibility of it
being washed off treated surfaces by rainfall in the field. Further,
potassium silicate is neutralized by stomach acid and primarily
excreted in the urine.
[[Page 34269]]
The components of potassium silicate are potassium and silicon.
Potassium is found in the environment and is an essential element in
human and plant nutrition. It is found in many fruits and vegetables
consumed by humans. A common soil plant nutrient and fertilizer (as
K2O), potassium comprises approximately 2.59% of the Earth's
crust by weight. The primary source of naturally-occurring soluble
potassium is from the weathering of potassium containing minerals.
Silicon is ubiquitous in the environment, the second most abundant
element in the lithosphere after oxygen. A nutritional element, silica
is required for proper and strong growth of mammalian bones. Silica is
present naturally in all plant stems and is present in larger amounts
in crops such as rice and sugar cane. It comprises approximately 31% of
the Earth's crust by weight and is present as dissolved silica,
amorphous silica in the solid phase (for example, silica and silica gel
(FDA GRAS chemicals), and silica bound to organic matter. In the normal
range of soil pH, silicic acid is the major silicate in soil water. In
natural waters most dissolved silica results from weathering of
silicate minerals. Research demonstrates that commercial soluble
silicates rapidly degrade to molecular forms that are indistinguishable
from natural dissolved silica (IUCLID, 1995). Beach sand, for example
is comprised of nearly 100% silica (Crop Protection handbook, 2003).
Additionally, silica is approved by the FDA for use as an anti-caking
agent in food.
Potassium silicate immediately breaks down in the presence of water
to the potassium and silicate ions which are indistinguishable from
natural components. As stated above, potassium silicate is produced by
direct fusion of precisely measured portions of pure silica sand
(SiO2) and potash (K2CO3) in a fired
furnace at temperatures above 1000[deg]C. Solutions of potassium
silicate are produced by dissolving alkali silica lumps in water at
elevated temperatures. Potassium silicate is classified as GRAS by FDA
(21 CFR 182.90 and 21 CFR 182.1711) for limited use in canned potable
water as a corrosion inhibiting agent and the EPA has exempted
potassium silicate from the requirement of a tolerance when used as an
inert ingredient, a surfactant, emulsifier, wetting agent, stabilizer,
or inhibitor (40 CFR 180.910). Data and/or information from the public
literature demonstrates a long history of safe use of fertilizers
containing potassium and silica. (HERA 2005, NOSB/TAP, 2003 and the
Silicon Dioxide and Silica Gel RED EPA, 1991, Kant, T., et al, 2003,
Savant N.K., et al., 1999). Fertilizers used in the agricultural
industry contain plant nutrients and micronutrients such as potassium
and silicon. Potassium silicate is approved by the USDA as a fertilizer
for conventional agriculture and is used on a variety of crops
including rice, wheat, barley, sugar cane, melons, grapes and cucurbits
(USDA/ERS, 2002, NOSB/TAP, 2003).
As mentioned above, silicon dioxide and its soluble silicates which
include potassium silicate have been fully characterized and assessed
by the Agency and other notable resources and it has been concluded
that silicon dioxide and its related soluble silicates exhibit moderate
to low toxicity, the Agency has therefore concluded there is a
reasonable certainty of no harm resulting from the use of potassium
silicate as an agricultural pesticide. This determination is based on
information from the literature which as stated above document the
similarity of silica (also known as silicon dioxide) and potassium
silicate. This information combined with the fact that the components
of potassium silicate (potassium and silica) are already naturally
present in the stems of all plants (silica) and naturally in foods
supports the Agency's conclusion that there is a reasonable certainty
of no harm resulting from the use of potassium silicate as an
agricultural pesticide and exposure from the use of potassium silicate
as a pesticide will not add to the exposure already present from its
natural occurrence, its presence in foods, in the human diet and in the
environment.
A. Acute Toxicity
The registrant did not submit any toxicity data testing the
technical grade of the active ingredient. Data waivers were requested
by the registrant and granted by the Agency based on the body of
extensive knowledge from the public literature and as researched by the
Agency. The toxicity of the soluble silicates via oral toxicity,
teratogenicity and genotoxicity were tested on the Technical Grade of
the Active Ingredient (TGAI) and reported and the Agency has relied
upon this information to support its decision to grant the waiver
requests for these studies. Acute toxicity data were submitted using
the end-use product as the test material which is approximately
a1/89/21/13/23/87/83/8 dilution of the technical grade of the
active ingredient. Requests for data waivers were granted for
additional toxicity studies described below. These data waiver requests
were granted based on the findings from comprehensive reviews and risk
assessments conducted on silicon dioxide (silica) and its related
soluble silicates (potassium silicate) with regard to its toxicity to
human health and the conclusion that silicon dioxide and its related
soluble silicates have moderate to low toxicity, and therefore, the
Agency concludes that there is a reasonable certainty of no harm
resulting from the use of potassium silicate. The data submitted and
waivers that were granted are as follows:
Acute oral rat OPPTS Harmonized Guideline 870.1100; Master Record
Identification (MRID) Number 46434903). LD50 = 5,000
milligrams/kilogram (mg/kg) (29.1% potassium silicate aqueous
solution). The test material is classified as a Toxicity Category IV
for acute oral toxicity and demonstrates that a dilution of the active
ingredient to a level that is comparable to the concentration of
potassium silicate in the proposed end-use product eliminates the
potential of the active ingredient to cause acute toxic effects. There
were no adverse effects reported at 5,000 mg/kg.
Technical grade of the active ingredient. A request to waive this
data requirement was submitted by the registrant. The Agency has
granted this data waiver based on: (1) Data from the public literature
which shows soluble silicates have a moderate to low acute toxicity by
the oral route (HERA 2005), (2) potassium silicate, a soluble silicate
that is both chemically and toxicologically similar to silicon dioxide
(silica) which has been fully characterized, assessed, and therefore
determined by the Agency that silicon dioxide and its related soluble
silicates pose no unreasonable adverse effects to human health when
used as an agricultural pesticide and (3) potassium and silica are
already present in the human diet as they are contained naturally in
various crops.
Acute dermal rat OPPTS 870.1200; (MRID 4643902). LD50 =
5,000 mg/kg (29.1% potassium silicate aqueous solution). The test
material is classified as a Toxicity Category IV for acute dermal
toxicity and demonstrates that a dilution of the active ingredient to a
level that is comparable to the concentration of potassium silicate in
the proposed end use product will be moderately irritating to the skin.
Technical grade of the active ingredient. Section 158.690(c)(2)(I)
states this test is not required if the test material is corrosive to
skin. Therefore, this test was not required. However, this active
ingredient is classified Toxicity Category I on the basis of potential
dermal irritation effects.
[[Page 34270]]
Acute inhalation rat OPPTS 870.1300; (MRID 46434906).
LC50 >2.06 milligrams per liter (mg/L) (29.1% potassium
silicate aqueous solution). The test material is classified as a
Toxicity Category IV for acute inhalation toxicity and demonstrates
that a dilution of the active ingredient to a level that is comparable
to the concentration of potassium silicate in the proposed end use
product will not cause acute inhalation effects at greater than 2.06 mg/L.
Technical grade of the active ingredient. This test is only
required if the product consists of a respirable material. Since
potassium silicate does not consist of a respirable material under
normal conditions of use, this test is not required.
B. Genotoxicity, Immune Response, Mutagenicity, Developmental,
Oncogenicity, Subchronic and Chronic Toxicity
The applicant requested to waive the data requirements below and
submitted a summary of public literature to satisfy the data
requirements for 90-day oral toxicity (OPPTS 870.3100), genotoxicity
(OPPTS 870.5100; 870.5300; 870.5375), teratogenicity (OPPTS 870.3700)
and immunotoxicity (OPPTS 880.3550) for the active ingredient.
Potassium silicate waiver requests were submitted (MRID 46434701). As
mentioned above, the Agency has determined that the data requirements
were met by the submission of public literature. The public literature
demonstrates that potassium silicate has low toxicity by the oral route
when tested as the TGAI because potassium silicate is neutralized by
stomach acid and primarily excreted in the urine. The high pH of the
pesticide product may cause eye and skin irritation to humans. However,
risks to humans will be reduced by dilution of the pesticide product
and further mitigated by the use of protective personal equipment.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. Potassium is found in the environment and is present in
the cells of humans and plants and is therefore an essential element in
human and plant nutrition. It is found in many fruits and vegetables
consumed by humans. Humans require an adequate supply of potassium from
consumption of foods for healthy growth and development. Humans consume
daily many sources of potassium, including a variety of fruits,
vegetables and beverages such as barley, bananas, plums, apricots,
strawberries, oranges, apples, grapes, spinach, potatoes, carrots,
celery, tomatoes, lettuce, cucumbers, milk, fruit juices, coffee, white
wine and light beers, etc. The average potassium content of the above
fruits and vegetables ranges from 2.4 K/kg (tomato) - 3.7 K/kg (banana).
As mentioned above, potassium is a common soil plant nutrient and
fertilizer (as K2O), and comprises approximately 2.59% of
the Earth's crust by weight. Silicon is a ubiquitous mineral nutrient
in the environment (soil, water) and the second most abundant element
in the lithosphere after oxygen. A nutritional trace element, silicon
is required for proper and strong growth and development 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 the human diet. The concentration of silicon in vegetable
plants varies greatly with cereals and grasses containing the highest
concentrations (0.2-2.0%).
Good agricultural practice when using potassium silicate means it
will most likely be used in aqueous solutions because application of
pure potassium silicate to crops is likely to be corrosive to crops
since the active ingredient is a known corrosive. When applied to food
crops at concentrations not to exceed 1% by weight of potassium
silicate in aqueous solution, it is highly unlikely there will be any
residues of significance in or on food.
Further dilution by tank mixing with water of a pesticide product
containing the active ingredient at 29% w/w of potassium silicate
before application of the pesticide reduces the amount of active
ingredient (to concentrations not to exceed 1% active ingredient) that
will be on the crop.
Furthermore, potassium silicate breaks down in the presence of
water to potassium and silicate ions, both of which occur naturally in
animals and plants. Concentrations of potassium silicate as a pesticide
in foliar sprays and nutrient solutions are dominated by silicic acid,
which as mentioned above, is readily absorbed by plants.
Therefore, given the use dilution of the pesticide product and
other good agricultural practices as required on product labels, the
likely dietary exposures to potassium silicate from the pesticidal uses
are not expected to add significantly to those levels of potassium
silicate already found in foods, beverages, and in drinking water as a
result of conventional agriculture and its natural occurrence in the
environment.
2. Drinking water exposure. Because potassium silicate breaks down
into potassium and silicate ions in the presence of water, there will
be no residues of potassium silicate in drinking water from its use as
a pesticide. The Agency does not expect the resulting potassium and
silicate ions resulting from this breakdown process will add
significantly to the level of potassium and silica presently in the water.
Potassium and silicon dioxide are ubiquitous in the environment,
and the uses of soluble silicates are widespread in dishwashing soaps,
other soaps, and detergents. Potassium silicate is classified by the
FDA as a GRAS substance (21 CFR 182.90 and 21 CFR 182.1711) for limited
use in canned potable water as a corrosion inhibiting agent. Moreover,
both potassium and silicon are already present in natural waters. The
potassium (natural) content of drinking water varies greatly depending
on its source and may be larger in mineral and spa waters than ordinary
tap water. On average, the daily water consumption by adults supplies
less than 0.1% of their potassium intake (European Fertilizer
Manufacturers Association, 1997). In natural waters most dissolved
silica results from weathering of silicate minerals and it has been
demonstrated that commercial soluble silicates rapidly degrade to
molecular forms that are indistinguishable from natural dissolved
silica. Therefore, because of the levels at which potassium and silica
(silicon dioxide) are already present in the water supply, the Agency
does not expect that the use of potassium silicate as a pesticide will
result in detectable exposures aside from what is currently in the
environment.
B. Other Non-Occupational Exposure
1. Dermal exposure. Non-occupational dermal exposures to potassium
silicate when used as a pesticide are expected to be negligible because
it is limited to agricultural use.
2. Inhalation exposure. Non-occupational inhalation exposures to
[[Page 34271]]
potassium silicate when used as a pesticide are expected to be
negligible because it is limited to agricultural use and will be used
as a spray.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
considers available information concerning the cumulative effects of a
particular pesticide's residues and other substances that have a common
mechanism of toxicity.
The information available at this time indicates that potassium
silicate when applied to food crops at a rate less than or equal to 1%
of potassium silicate by weight in aqueous solution does not have a
toxic effect. Therefore, cumulative effects from the residues of this
product are not anticipated.
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. The Agency has determined that there is
reasonable certainty that no harm will result to the U.S. population
from aggregated exposure to residues of potassium silicate when used in
an aqueous solution in which the potassium silicate does not exceed
29.1% by weight. This includes all anticipated dietary exposures and
other exposures for which there is reliable information. The Agency
arrived at this conclusion based on the anticipated low acute exposure
estimates from its pesticidal use, the low mammalian toxicity in its
diluted form, the widespread exposure to potassium and silica, from
foods in the human diet, and the similarity both chemically and
toxicologically to silicon dioxide which has already been fully
characterized and assessed, and found that there is reasonable
certainty of no harm that will result from the use of silicon dioxide
and its related soluble silicates (potassium silicate) as an
agricultural pesticide.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure (MOE) for infants and
children in the case of threshold effects. Margins of exposure are
often referred to as uncertainty or safety factors, and are used to
account for potential prenatal and postnatal toxicity and any lack of
completeness of the data base. Based on available data and other
information, EPA may determine that a different MOE will define a level
of concern for infants and children or that a MOE approach is not
appropriate. Based on all the available information the Agency reviewed
on potassium silicate, including a lack of threshold effects, the
Agency concluded that potassium silicate, in its diluted form, is
practically non-toxic to mammals, including infants and children. Since
there are no effects of concern, the provision requiring an additional
margin of safety does not apply.
VII. Other Considerations
A. Endocrine Disruptors
Based on available data, no endocrine system-related effects have
been identified with consumption of potassium silicate. In addition,
there is no evidence to suggest that potassium silicate functions in a
manner similar to any known hormone.
B. Analytical Method(s)
The Agency proposes to establish an amendment to the exemption from
the requirement of a tolerance without any numerical limitation for
residues since it has determined that residues resulting from the
pesticidal uses of potassium silicate would be so low as to be
indistinguishable from the naturally occurring silicates that are
ubiquitous in the environment.
C. Codex Maximum Residue Level
There are no Codex Maximum Residue Levels for this chemical.
VIII. Conclusions
Based on the toxicology data submitted, there is reasonable
certainty no harm will result to the U.S. population including infants
and children from aggregate exposure of residues of potassium silicate
when the product is used in accordance with good agricultural
practices. This includes all anticipated dietary exposures and all
other exposures about which there is reliable information. As a result,
EPA establishes an exemption from tolerance requirements pursuant to
FFDCA 408(c) and (d) for residues of potassium silicate in or on all
food commodities so long as the potassium silicate is not applied to
food crops at rates that exceed 1% potassium silicate by weight in an
aqueous solution.
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described underTitle II of the Unfunded
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it
require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby certifies that this rule will not
have significant negative economic impact on a substantial number of
small entities. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and
[[Page 34272]]
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 31, 2006.
James Jones,
Director, Office of Pesticide Programs.
? Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
? 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
? 2. Section 180.1268 is added to subpart D to read as follows:
Sec. 180.1268 Potassium silicate; exemption from the requirement of a
tolerance.
Potassium silicate is exempt from the requirement of a tolerance in
or on all food commodities so long as the potassium silicate is not
applied at rates exceeding 1% by weight in aqueous solution and when
used in accordance with good agricultural practices.
[FR Doc. E6-8939 Filed 6-13-06; 8:45 am]
BILLING CODE 6560-50-S