Document ID: EPA-HQ-OPP-2002-0241-0002
Agency: epa
Document Type: Rule
Title: Sodium Metasilicate; Amendment to an Exemption From the Requirement of a Tolerance
Posted Date: 2006-04-14T12:36:28Z

[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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
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