FR Doc 05-18241

[Federal Register: September 14, 2005 (Volume 70, Number 177)]
[Rules and Regulations]
[Page 54281-54286]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14se05-12]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0362; FRL-7729-7]

Alkyl (C10-C16) Polyglycosides; Exemptions
from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes two exemptions from the
requirement of a tolerance for residues of alkyl (C10-
C16) polyglycosides also known as D-glucopyranose,
oligomeric, C10-C16-alkyl glycosides when used as
an inert ingredient in or on growing crops, when applied to raw
agricultural commodities after harvest, or to animals. Cognis
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 D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides.

DATES: This regulation is effective September 14, 2005. Objections and
requests for hearings must be received on or before November 14, 2005.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2003-0362. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. 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.

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; e-mail address: boyle.kathryn@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 Get Electronic Documents and Other Related Information?

In addition to using EDOCKET at (http://www.epa.gov/edocket/), you

may 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 10, 2003 (68 FR 68908) (FRL-
7335-5), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing
the filing of a pesticide petition (PP 4E4332) by Cognis Corporation,
490 Este Avenue, Cincinnati, OH 45232. That notice included a summary
of the petition prepared by the petitioner.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of alkyl (C10-C16) polyglycosides or
polyglucosides, also known as D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides (CAS Reg. No. 110615-47-
9) when used as an inert ingredient in pesticide products. There were
no comments received in response to the notice of filing.
The Agency has determined that the use of D-glucopyranose,
oligomeric, C10-C16-alkyl glycosides (CAS Reg.
No. 110615-47-9) in a pesticide product is as a surfactant.
Section 408(b)(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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of the FFDCA
requires 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....''
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. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not

[[Page 54282]]

intended to imply nontoxicity; the ingredient may or may not be
chemically active. Generally, EPA has exempted inert ingredients from
the requirement of a tolerance based on the low toxicity of the
individual inert ingredients.

IV. 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. The information submitted by the
petitioner for review and evaluation included information on toxicity
studies performed on alkyl (C8-C10)
polyglycosides, and alkyl (C12-C14)
polyglycosides. The actual substance used for each test is noted below.
An alkyl polyglycoside is created by combining glucose and an
alcohol. Alkyl (C8-C10) polyglycosides and alkyl
(C12-C14) polyglycosides are structurally-related
to the alkyl (C10-C16) polyglycosides also known
as D-glucopyranose, oligomeric, C10-C16-alkyl
glycosides that is the subject of this final rule. These chemicals
differ from one another only in the length of the alkyl chain. Given
these structural similarities, these chemicals have similar
toxicological characteristics.
Two types of data were submitted by the petitioner: Publicly-
available information from open literature and complete toxicity
studies. The results of the existing reviews in the publicly-available
information were extracted from the submitted article. The complete
toxicity studies included two mutagenicity studies, a subchronic 90 day
study, and a developmental study. These studies were reviewed by the
Department of Energy's Oakridge National Laboratory (ORNL), and the
results of their review are presented below, noted by an asterisk (*).

A. Acute Toxicity

Table 1.--Acute Toxicity Studies
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Study/Species Test Substance Results
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Acute oral toxicity/rat C8-C14 Lethal Dose (LD)50 > 5,000
milligrams/kilogram (mg/kg)
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Acute oral toxicity/rat C12-C14 LD50 > 5,000 mg/kg
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Acute oral toxicity/rat C12-C14 LD50 > 2,000 mg/kg
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Acute dermal toxicity/rabbit C8-C10 LD50 > 2,000 mg/kg
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Acute dermal toxicity/rabbit C12-C14 LD50 > 2,000 mg/kg
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Primary eye irritation/rabbit C8-C10 No irritating effects
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Primary eye irritation/rabbit C12-C14 Irritating to the eye
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Primary dermal irritation/rabbit C8-C10 No irritating effects
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Primary dermal irritation/rabbit C12-C14 No irritating effects at
concentrations of up to 30%
Irritating to the skin at
concentrations greater than 30% to
100%.
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Dermal sensitization/guinea pig C8-C10 Not a dermal sensitizer
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Dermal sensitization/guinea pig C12-C14 Not a dermal sensitizer
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Table 2.--Mutagenicity Studies
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Type of Study Test Substance Results
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Salmonella/Escherichia reverse gene C12-C14 Negative. No evidence of induced
mutation assay (Ames Test)* mutant colonies over background.
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Salmonella typhimurium reverse (Ames Not specified Did not induce reverse mutations
Test) in the tested strains of
Salmonella typhimurium either with
or without metabolic activation.
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In vitro cytogenetic test in Chinese Not specified Considered to be non-mutagenic.
hamster V79 lung fibroblast
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In vitro mammalian cytogenetics assay* C12-C14 Negative with and without
activation.
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B. Repeated Dose Toxicity*

In a 90-day rat oral (gavage) toxicity study, alkyl
(C12-C14) polyglucosides was administered at dose
levels of 0, 250, 500, or 1,000 mg/kg/day for 5 days/week. An
additional high-dose group was treated and then had a treatment-free
period of 27 days before sacrifice.
There were no treatment-related adverse effects on body weight,
body

[[Page 54283]]

weight gain, food consumption, hematological or clinical chemistry
parameters or organ weights in any group. Adverse treatment-related
effects were limited to the forestomach in both males and females
receiving 500 or 1,000 mg/kg/day. After 27 days, it was observed that
forestomach effects were reversible following the cessation of
treatment, but not during treatment. Under the conditions of the study,
the NOAEL (no observed adverse effect level) for alkyl (C12-
C14) polyglucosides is 250 mg/kg/day. The LOAEL (lowest
observed adverse effect level) is 500 mg/kg/day based on acanthosis,
subepithelial inflammatory edema, and hyperkeratosis (females only) of
the forestomach, which did not resolve during the treatment period.

C. Developmental Toxicity*

In a rat developmental toxicity study, alkyl (C12-
C14) polyglucosides was administered by gavage at dose
levels of 0, 100, 300, and 1,000 mg/kg/day on gestation days 6 to 15.
No treatment related maternal deaths, clinical signs, or decreases in
mean body weight, weight gain, corrected weight gain or gross lesions
were observed in this study. The maternal NOAEL is equal to or greater
than 1,000 mg/kg/day. A LOAEL was not determined, but would be greater
than 1,000 mg/kg/day.
No treatment-related effects were observed on any cesarean section
parameter. No treatment-related external abnormalities, visceral
abnormalities or skeletal malformations/variations, including the
number of ossification sites were observed at any dose. The
developmental NOAEL is equal to or greater than 1,000 mg/kg/day. A
LOAEL was not determined, but would be greater than 1,000 mg/kg/day.

D. Metabolism

The petitioner submitted an article from open literature on
metabolism studies in mice conducted with the structurally-related
chemicals (octyl [beta]-D-glucoside, dodecyl [beta]-D-maltoside, and
hexadecyl [beta]-D-glucoside). The radiolabeled test material consisted
of octyl [beta]-D-[U-¹⁴C]glucoside, [l-
¹⁴C]dodecyl [beta]-D-maltoside and [l-
¹⁴C]hexadecyl [beta]-D-glucoside). The treated animals were
sacrificed two hours following administration of the test material.
Radioactivity analysis indicated that most radioactivity was found in
the stomach, intestine, liver and kidneys. The test material was
hydrolyzed to form sugar and long chain alcohols, which were then
processed in the mammalian body's pathways for carbohydrate and lipid
metabolism. Most metabolites were excreted via urine, and appeared to
be water soluble.

E. Conclusions

Acute toxicity studies on various chain lengths of alkyl
polyglucosides indicate that D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides is likely to be of low
acute oral and dermal toxicity. However, based on the surrogate data,
D-glucopyranose, oligomeric, C10-C16-alkyl
glycosides is likely to be an eye and dermal irritant when used at
higher concentrations.
Metabolism studies on structurally-related chemicals indicate that
the body can effectively metabolize D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides to water-soluble
substances (predominantly sugar and various alcohols) that are readily
excreted from the body.
In a 90-day rat oral (gavage) toxicity study, using alkyl
(C¹²-C¹⁴) polyglucosides, the NOAEL (no observed
adverse effect level) for alkyl (C¹²-C¹⁴)
polyglucosides is 250 mg/kg/day. In a rat developmental toxicity study
using alkyl (C¹²-C¹⁴) polyglucosides, both the
maternal and developmental NOAELs are equal to or greater than 1000 mg/
kg/day.
Mutagenicity studies on various chain lengths of alkyl
polyglucosides indicate that D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides is not likely to be
mutagenic based on the two mutagenicity assays reviewed by the Agency
and the two mutagenicity assays described in open literature.

V. 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).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.

A. Dietary Exposure

1. Food. The Agency has developed a screening-level model for
predicting dietary exposure to inert ingredients. The results of this
model are considered to over-estimate exposure to an inert ingredient
in a pesticide product. The modeled chronic dietary exposure for the US
population is 0.12 mg/kg/day. This is well-below any dose level at
which an adverse effect is expected from exposure to D-glucopyranose,
oligomeric, C10-C16-alkyl glycosides.
2. Drinking water exposure. EPA has estimated the fate and
biodegradation properties of D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides using EPI-Suite.
Screening-level tools such as EPI-Suite are deliberately designed to be
easy-to-use, fast, and conservative in nature. (see http://www.epa.gov/opptintr/exposure/docs/episuite.htm
). If modeled estimates do not

indicate a level of concern, then higher-tiered modeling or measured
data may not be needed. The modeled estimates indicate that a chemical
substance such as D-glucopyranose, oligomeric, C10-
C16-alkyl glycosides is expected to degrade rapidly in the
environment. Degradation begins within a matter of hours or days, with
these primary degradation products including glucose and various
alcohols which will continue to degrade. Ultimate degradation (to
carbon dioxide and water) occurs in days to weeks. These glycoside
compounds are soluble, non-volatile, and mobile. Leaching to ground
water is likely in highly porous soils, but mitigated in other soils
due to the rapid biodegradation. Volatilization from surface waters is
very low. Migration to ground water drinking water sources is possible,
but will be limited by the rapid primary degradation.
Based on values estimated using the EPI-Suite model, it is very
unlikely that D-glucopyranose, oligomeric, C10-
C16-alkyl glycosides will reach either ground or surface
water, or bioaccumulate in the environment. This conclusion is based on
its rather rapid primary degradation (estimated to be hours to days),
and ultimate biodegradation to carbon dioxide and water. Significant
concentrations of D-glucopyranose, oligomeric, C10-
C16-

[[Page 54284]]

alkyl glycosides in sources of drinking water is very unlikely.

B. Other Non-Occupational Exposure

Various alkyl polyglucosides are used in glass cleaners and other
household cleaning products, as rinse aids in dish washers, and in
cleaning products used by the food industry.

VI. Cumulative Effects

Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding for D-glucopyranose, oligomeric,
C10-C16-alkyl glycosides. D-glucopyranose,
oligomeric, C10-C16-alkyl glycosides does not
appear to produce any toxic metabolite produced by other substances and
the overall toxicity of this compound is very low. For the purposes of
this tolerance action, therefore, EPA has not assumed that D-
glucopyranose, oligomeric, C10-C16-alkyl
glycosides 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, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VII. Safety Factor for Infants and Children

FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database unless EPA concluded that a different
margin of safety will be safe for infants and children.
D-glucopyranose, oligomeric, C10-C16-alkyl
glycosides is of low acute toxicity, and is readily metabolized in the
mammalian body. In a developmental toxicity study reviewed and
evaluated by ORNL for EPA, the developmental NOAEL is equal to or
greater than 1,000 mg/kg/day. Due to the expected low oral toxicity, a
safety factor analysis has not been used to assess the risk of D-
glucopyranose, oligomeric, C10-C16-alkyl
glycosides. For the same reasons, the additional tenfold safety factor
for the protection of infants and children is unnecessary.

VIII. Determination of Safety for U.S. Population, and Infants and
Children

Based on the available toxicity data, EPA judges that D-
glucopyranose, oligomeric, C10-C16-alkyl
glycosides is a chemical of lower toxicity. Therefore, EPA concludes
that there is a reasonable certainty of no harm from aggregate exposure
to residues of D-glucopyranose, oligomeric, C10-
C16-alkyl glycosides (CAS Reg. No. 110615-47-9). EPA finds
that establishing an exemption from the requirement of a tolerance for
D-glucopyranose, oligomeric, C10-C16-alkyl
glycosides (CAS Reg. No. 110615-47-9) will be safe for the general
population including infants and children.

IX. Other Considerations

A. Endocrine Disruptors

FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. . .'' EPA has been working with interested
stakeholders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing D-glucopyranose,
oligomeric, C10-C16-alkyl glycosides for
endocrine effects may be required.

B. Analytical Method(s)

An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

C. Existing Exemptions

There are no existing tolerances or tolerance exemptions for D-
glucopyranose, oligomeric, C10-C16-alkyl
glycosides

D. International Tolerances

The Agency is not aware of any country requiring a tolerance for D-
glucopyranose, oligomeric, C10-C16-alkyl
glycosides nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.

X. Conclusions

Accordingly, an exemption from the requirement for a tolerance is
established for D-glucopyranose, oligomeric, C10-
C16-alkyl glycosides (CAS Reg. No. 110615-47-9).

XI. 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 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 FFDCA 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 OPP-2003-0362 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 November
14, 2005.
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 issue(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

[[Page 54285]]

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 XI.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 OPP-2003-0362, to: Public
Information and Records Integrity Branch, Information Resources and
Services 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 in ADDRESSES. 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 issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

XII. Statutory and Executive Order Reviews

This final rule establishes 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 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. 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 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.

XIII. 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.

[[Page 54286]]

Dated: September 2, 2005.

Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. In Sec. 180.910 the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec. 180.910 Inert ingredients used pre- and post-harvest; exemption
from the requirement of a tolerance.

* * *

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
D-glucopyranose, oligomeric, .................. Surfactant
C10 16-alkyl glycosides (CAS
Reg. No. 110615-47-9)
* * * * * * *
------------------------------------------------------------------------

* * * * *
0
3. In Sec. 180.930 the table is amended by adding alphabetically the
following inert ingredient to read as follows:

Sec. 180.930 Inert ingredients applied to animals; exemption from the
requirement of a tolerance.

* * *

* * * * *

[FR Doc. 05-18241 Filed 9-13-05; 8:45 am]

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