[Federal Register: April 14, 2006 (Volume 71, Number 72)]
[Rules and Regulations]
[Page 19436-19441]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap06-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2002-0241; FRL-8063-5]
Sodium Metasilicate; Amendment to an Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an amendment to an exemption from
the requirement of a tolerance for residues of sodium metasilicate on
all food commodities when applied/used as an insecticide or fungicide
to control or suppress leafhoppers and powdery mildew in accordance
with approved label rates and good agricultural practice. A petition
was submitted to EPA on behalf of Environmentally Safe Systems, Inc.
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 sodium
metasilicate.
DATES: This regulation is effective April 14, 2006. Objections and
requests for hearings must be received on or before June 13, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit IX. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2002-0241. All documents are
listed on the http://www.regulations.gov web site. (EDOCKET, EPA's electronic
public docket and comment system was replaced on November 25, 2005, by
an enhanced federal-wide electronic docket management and comment
system located at http://www.regulations.gov/. Follow the on-line
instructions.) Although listed in the index, some information is not
publicly available, i.e., 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 either electronically in EDOCKET or in hard copy 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.
[[Page 19437]]
FOR FURTHER INFORMATION CONTACT: Raderrio Wilkins, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-1259; e-mail address:wilkins.raderrio@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), youmay
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of December 29, 2004 (69 FR 78017) (FRL-
7193-8), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 2E6381) by Interregional Research Project Number
(IR-4), New Jersey Agricultural Experiment Station, Technology Center
of New Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-
3390, on behalf of Environmentally Safe Systems, Inc., P.O. Box 1574
Sanat Ynez, CA 93460. ChemReg International, LLC, 1990 Old Bridge Road,
Suite 201, Lake Ridge, VA 22192, is the current authorized agent acting
on behalf of Environmentally Safe Systems, Inc. The petition requested
that 40 CFR part 180 be amended by establishing an exemption from the
requirement of atolerance for residues of sodium metasilicate. This
notice included a summary of the petition prepared by the petitioner
ChemReg International, LLC on behalf of Environmentally Safe Systems,
Inc. There were no comments received in response to the notice of
filing.
Since the IR-4's submission of this petition, EPA has promulgated a
regulation establishing an exemption from the requirement of a
tolerance for sodium metasilicate at 40 CFR 180.1237. That exemption
establishes an exemption from the requirement of a tolerance for
residues of sodium metasilicate ``when used as plant desiccants, so
long as the metasilicate does not exceed 4% by weight in aqueous
solution.'' Because IR-4's petition requested an exemption from the
requirement for a tolerance for sodium metasilicate when used as an
insecticide and fungicide, the current exemption does not cover the
petitioned uses and must be amended to include them.
Section 408(c)(2)(A)(i) of the 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 the 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 the 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 the 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.
Sodium metasilicate is prepared by fusing sand (silicon
dioxide,SiO2) and soda ash (NaCO3). Sand or
silicon dioxide is comprised of silica, which is one of the most
abundant oxide materials in the earth's crust. Silica occurs commonly
in nature as sandstone, silica sand or quartzite. It is the starting
material for the production of silicate glasses and ceramics. It can
exist in an amorphous form (vitreous silica) or in a variety of
crystalline forms. Often it will occur as a non-crystalline oxidation
product on the surface of silicon or silicon compounds. Silicon is
widely distributed in the environment, and is present in the form of
sand on all beaches.
Sodium metasilicate is a corrosive alkaline material commercially
available in three forms (anhydrous, pentahydrate or nonahydrate
containing 0, 5 or 9 water molecules in its crystal structures,
respectively). In its pure form sodium metasilicate is corrosive to
skin and eyes, and is a severe irritant to the upper respiratory tract.
It may cause burns of the mouth, throat and stomach. This tolerance
exemption covers all three forms of sodium metasilicate because all
three forms are soluble in water, and thus in aqueous dilutions at
2.41%, which is the concentration proposed for pesticide products used
as insecticides and fungicides, the toxicity would be the same. For
this reason, unless otherwise specified in this document, whenever the
term sodium metasilicate is used in this document, it refers to all
three forms of sodium metasilicate.
Sodium metasilicate is widely used in cosmetics, hair and skin
products, detergents, and a variety of cleaning products. It is also an
active ingredient
[[Page 19438]]
in insecticides, fungicides and antimicrobial pesticides at
concentrations up to 4%, and its primary modes of action include
abrasion and dessication of the targeted pests. The pentahydrate
(Na2SiO35H20) is classified by the
Food and Drug Administration (FDA) as ``Generally Recognized as Safe''
(GRAS, indirect food ingredient) for use in washing mixtures for fruits
and vegetables, in sanitizing solutions on food-contact surfaces, and
other uses. Residues of the pentahydrate form, when used in fruit and
vegetable washes, are expected to be orders of magnitude less than the
estimated daily dietary consumption of 20-30 milligrams (mg) silica
from natural sources and drinking water. Silica (also known as silicon
dioxide, SiO2, or silicon) is a degradation product of the
pentahydrate form of sodium metasilicate, which is neutralized by
stomach acid after oral ingestion to form silicic acid
(H2SiO3). Silicic acid is readily absorbed and distributed
throughout the body where it may be further metabolized to silicon
dioxide. Silicon is incorporated into tissues as an essential trace
element, and is especially important in bone growth and development in
poultry and livestock. Silica is also used as a food additive,
primarily as a flow agent in powdered foods, or to absorb water.
The toxicological data to support the request to amend the
exemption from the requirement of a tolerance for sodium metasilicate
is comprised of published information on all three forms of sodium
metasilicate and related silicon-containing compounds. Silicon dioxide
is the focus of many of the studies considered by the Agency since it
is a metabolite of sodium metasilicate pentahydrate after oral
ingestion and is an essential trace element in the diet.
1. Acute oral toxicity data (MRID 46050902) for the anhydrous form
of sodium metasilicate in rats was classified Toxicity Category III,
due to gastrointestinal irritation and corrosion at doses great than or
equal to 1,000 mg of the active ingredient per kilogram (kg) body
weight. The alkalinity (pH of 12) of the test material would be
expected to cause these gastrointestinal effects and is consistent with
the known irritation and corrosivity of high doses (such as the level
tested in this study) for sodium metasilicate. There were no effects
noted in a second acute oral toxicity study (OPPTS Harmonized Guideline
870.1100; MRID 46202005) with rats given 5,000 mg of a test material
containing only 2.41% sodium metasilicate (approximately 120 mg) per kg
body weight. The test material is classified as Toxicity Category IV
for acute oral toxicity, and demonstrates that a dilution of the active
ingredient to a level that is comparable to concentration of sodium
metasilicate required in the proposed pesticidal uses for control of
leafhoppers and powdery mildew (eliminates the potential of the active
ingredient to cause acute toxic effects).
2. Environmentally Safe Systems, Inc. requested waivers based on
submitted reviews of publicly available scientific literature (MRID
46050902) for the following required studies on the technical grade of
the active ingredient:
i. OPP Guideline 152.17--Genotoxicity. Genetic toxicity assays
considered from the submitted review of published scientific literature
included microbial point mutation assays with sodium metasilicate,
silicic acid, and silicon dioxide. None of these substances
demonstrated mutagenic activity in three bacterial test species.
ii. OPP Guideline 152.20--Subchronic, 90-day feeding. Subchronic
toxicity data summarized from published literature on silicon dioxide
demonstrated adverse effects at high oral doses in rats, mice and dogs
without determining no observed adverse effect levels (NOAEL) in these
test species. An 800 mg/kg body weight/day dose level administered
orally to dogs for 6 months was reported to have kidney effects, which
were not observed after only 4 weeks. These results indicate that
amounts ofSiO2 exceeding the natural demand for the
essential trace element silicon are excreted via the kidneys and can
have effects there after an extended period of exposure. Therefore,
longer exposures to repeated, high oral doses increase the potential
for adverse effects in this test species. The report on the effects in
dogs also indicated that kidney function was not adversely affected by
the microscopic changes noted in the organ.
Chronic toxicity. The summary review of the published literature
indicated that silicon dioxide (SiO2) was fed to rats and
mice at dietary levels up to 50,000 parts per million (ppm) (5% of the
diet; approximately 2,500 and 7,500 mg/kg/day for rats and mice,
respectively) for 2 years. The only effect noted was a significant
reduction in body weight at the highest dose at the 10-week point of
the mouse study, which continued throughout the rest of the test, which
is likely attributable to the high percentage of silica in the daily
diet of the test animals. No adverse effects were observed in rats.
iii. OPP Guideline 152.23--Teratogenicity. The published scientific
literature describes silicon as essential for growth and development
the skeleton, hair and feathers in rats, chicks, and other animals.
Although no developmental toxicity studies were submitted, publicly
available literature provided information on the effects on
reproduction for sodium silicate (``soluble silica'' expressed also as
silicon dioxide). In that study, sodium silicate was given in drinking
water to rats for up to 180 days (120 and 240 mg/kg body weight/day at
the beginning of the study when the rats were 3 weeks old, and 72 and
144 mg/kg/day by the end of the study, which is the calculated dose
based on their growth to adults during the study). A decrease in
numbers of live offspring at birth and at weaning was noted; however, a
conclusion cannot be made that the silicates actually caused
reproductive toxicity. The conditions of the study were inappropriate
for normal mating and nurturing behaviors in the test animals. The use
of wire-bottom cages would allow escape, illness or injury of the
offspring, due to the absence of nesting materials for proper nurturing
and heat retention, thus compounding the association of reproductive
effects with silicate intake. Based on the alkaline nature of sodium
metasilicate, when ingested it is neutralized by the stomach acid pH
(less than 2), which greatly reduces it solubility by forming polymeric
silicic acid, and thus the actual absorption of sodium metasilicate
into the blood and tissues of the body is physically limited. This is
demonstrated by the lack of significant effects on the body weights of
the treated rats during the non-reproduction phase of the published
study after dosing with soluble silica at the 72 mg/kg/day dose level.
Since dietary exposure results in minimal absorption into body tissues,
the Agency does not anticipate developmental or reproductive risks from
the use, at 2.41% of sodium metasilicate as an insecticide and
fungicide on growing crops.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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. Sodium metasilicate is generally recognized as safe by the
FDA
[[Page 19439]]
for use as a wash for fruits and vegetables. According to FDA findings,
the residues from this use are expected to be orders of magnitude less
than the estimated daily intake of 20-30 mg silica(SiO2)
from natural sources and drinking water. The submitted summary of
information on sodium metasilicate (MRID 46050902) also indicated that
the FDA has established maximum permissible concentrations of sodium
metasilicate in potable water, fruits and vegetables at 16.0 ppm and
300 ppm, respectively.
There are a number of factors that inform EPA's conclusion that
there is not likely to be much dietary exposure. First, sodium
metasilicate neutralizes and breaks down under acidic conditions such
as that found in the digestive tract. Second, further dilution by tank
mixing with water of a pesticide product containing the active
ingredient containing only 2.41% or less of sodium metasilicate by
weight before foliar application reduces the amount of active
ingredient that will be on the crop. These factors taken together
significantly reduce the potential for dietary exposure from its
pesticidal uses. Further, if the active ingredient is applied to
growing crops at higher rates, the result is abrasion and dessication
of the food crops. Therefore, good agricultural practices dictate that
the amount of sodium metasilicate used be limited to low concentrations
which happen to be appropriate for the intended pesticidal uses. Given
the use dilutions and other good agricultural practices as required on
product labels, the likely dietary exposures to sodium metasilicate
from the pesticidal uses are expected to be equal to or even less than
levels recommended by the FDA for fruit and vegetable washes.
2. Drinking water exposure. Sodium metasilicate residues in
drinking water are expected to be minimal from its use as a pesticide,
especially when compared to the ubiquity of naturally occurring forms
of silicon dioxide in the environment, and the widespread use of sodium
metasilicate in dishwashing soaps, other soaps, and detergents. As
mentioned above, pesticide products containing 2.41% or less of sodium
metasilicate are diluted at least 10 times before foliar application,
and are not likely to exceed the level recommended for potable water
(16 ppm).
B. Other Non-Occupational Exposure
1. Dermal exposure. Non-occupational dermal exposures to sodium
metasilicate 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
sodium metasilicate when used as a pesticide are expected to be
negligible because it is limited to agricultural use.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider the ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA does not have available data to determine whether sodium
metasilicate has a common mechanism of toxicity with any other
substances. The mode of action as a contact insecticide and fungicide
is considered by the Agency as a non-toxic mode of action on the target
pest species. Further, sodium metasilicate does not appear to produce
any toxic metabolites. Therefore, for the purpose of this tolerance
exemption action, EPA has not assumed that sodium metasilicate has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, refer to the policy statement released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effect from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
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 from aggregated exposure
to residues of sodium metasilicate to the U.S. population. 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 use in the human diet, and that sodium metasilicate is
considered GRAS under 21 CFR 184.1769a and is permitted to be added
directly to food for human consumption.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure 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 margin of exposure will
define a level of concern for infants and children or that a margin of
exposure approach is not appropriate. Based on all the available
information the Agency reviewed on sodium metasilicate, including a
lack of threshold effects, the Agency concluded that sodium
metasilicate, 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 sodium metasilicate. In addition,
there is no evidence to suggest that sodium metasilicate 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 sodium metasilicate 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 established for residues
of sodium metasilicate.
VIII. Conclusions
An exemption from the requirement for a tolerance is appropriate
because of the low dietary exposure likely to result from the
pesticidal use of sodium metasilicate, the nature of its mode of action
on the targeted pests, the metabolism of the active ingredient to other
forms of silicon that is needed for growth and development in animals,
and its moderate to low oral toxicity in diluted formulations
(necessary to prevent damage to crops while maintaining effectiveness
as a pesticide).
IX. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this
[[Page 19440]]
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. Although the
procedures in those regulations require some modification to reflect
the amendments made to the FFDCA by the FQPA, EPA will continue to use
those procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) of the FFDCA provides
essentially the same process for persons to ``object'' to a regulation
for an exemption from the requirement of a tolerance issued by EPA
under new section 408(d) of the FFDCA, as was provided in the old
sections 408 and 409 of the FFDCA. However, the period for filing
objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2002-0241 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 June 13,
2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI.Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number EPA-HQ-OPP-2002-0241, to:
Public Information and Records Integrity Branch, Information Technology
and Resource Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described inADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. Statutory and Executive Order Reviews
This final rule establishes an amendment to an exemption from the
tolerance requirement under section 408(d) of the 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 under Title 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 the FFDCA, such as the amendment to
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 a 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
responsibilities among the various levels of government.'' This final
rule
[[Page 19441]]
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 the 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
(65 FR 67249, 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.
XI. 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: March 30, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. Section 180.1237 is revised to read as follows:
Sec. 180.1237 Sodium metasilicate; exemption from the requirement of
a tolerance.
(a) An exemption from the requirement of a tolerance is established
for residues of sodium metasilicate in or on all food commodities when
used in accordance with approved label rates and good agricultural
practices as a plant desiccant, so long as the sodium metasilicate does
not exceed 4% by weight in aqueous solution.
(b) An exemption from the requirement of a tolerance is established
for residues of sodium metasilicate in or on all food commodities when
used in accordance with approved label rates and good agricultural
practices as an insecticide and fungicide, so long as the sodium
metasilicate does not exceed 2.41% by weight in aqueous solution.
[FR Doc. 06-3549 Filed 4-13-06; 8:45 am]
BILLING CODE 6560-50-S