Ethylhexyl Glucopyranosides; Exemption from the Requirement of a Tolerance, 54275-54281 [05-18244]
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Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations
40 CFR part 52 is amended to read as
follows:
Ogden,’’ adopted by the Utah Air
Quality Board on November 3, 2004,
effective January 4, 2005.
(B) UAC R307–110–35, ‘‘Section X,
Vehicle Inspection and Maintenance
Program, Part E, Weber County,’’ as
adopted by the Utah Air Quality Board
on November 3, 2004, effective
November 4, 2004.
(ii) Additional Materials
(A) A July 28, 2005 letter from Jan
Miller, Utah Department of
Environmental Quality, to Kerri Fiedler,
EPA Region VIII, to address
typographical errors in the November
29, 2004 submittal.
(B) An August 2, 2005 letter from
Richard Sprott, Utah Department of
Environmental Quality, to Gary House,
Weber-Morgan Board of Health,
addressing limits on Weber County
authority to revise vehicle emission
cutpoints.
PART 52—[AMENDED]
[FR Doc. 05–18232 Filed 9–13–05; 8:45 am]
1. The authority citation for part 52
continues to read as follows:
BILLING CODE 6560–50–P
this final rule does not affect the finality
of this rule for the purposes of judicial
review nor does it extend the time
within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. (See section
307(b)(2).)
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Reporting
and recordkeeping requirements.
Dated: August 17, 2005.
Stephen S. Tuber,
Acting Regional Administrator, Region VIII.
I
I
Authority: 42 U.S.C. 7401 et seq.
ENVIRONMENTAL PROTECTION
AGENCY
Subpart TT—UTAH
40 CFR Part 180
2. Section 52.2320 is amended by
adding paragraph (c)(61) to read as
follows:
I
§ 52.2320
[OPP–2002–0166; FRL–7729–6]
Identification of plan.
*
*
*
*
*
(c) * * *
(61) Revisions to the Utah State
Implementation Plan, Section IX, Part
C.8, ‘‘Carbon Monoxide Maintenance
Provisions for Ogden,’’ as submitted by
the Governor on November 29, 2004;
revisions to UAC R307–110–12,
‘‘Section IX, Control Measures for Area
and Point Sources, Part C, Carbon
Monoxide,’’ as submitted by the
Governor on November 29, 2004;
revisions to the Utah State
Implementation Plan, Section X,
‘‘Vehicle Inspection and Maintenance
Program, Part E, Weber County,’’ as
submitted by the Governor on
November 29, 2004; and revisions to
UAC R307–110–35, ‘‘Section X, Vehicle
Inspection and Maintenance Program,
Part E, Weber County,’’ as submitted by
the Governor on November 29, 2004.
(i) Incorporation by reference.
(A) UAC R307–110–12, as adopted by
the Utah Air Quality Board on
November 3, 2004, effective January 4,
2005. This incorporation by reference of
UAC R307–110–12 only extends to the
following Utah SIP provisions and
excludes any other provisions that UAC
R307–110–12 incorporates by reference:
Section IX, Part C.8, ‘‘Carbon
Monoxide Maintenance Provisions for
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Ethylhexyl Glucopyranosides;
Exemption from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
two exemptions from the requirement of
a tolerance for residues of [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl when
used as inert ingredients in or on
growing crops. Akzo Nobel Surface
Chemistry LLC 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 these two ethylhexyl
glucopyranoside chemicals.
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
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54275
docket for this action under Docket
identification (ID) number OPP–2002–
0166. All documents in the docket are
listed in the EDOCKET index at https://
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
(https://www.epa.gov/edocket/), you may
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access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of August 7,
2002 (67 FR 51260) (FRL–7190–4), 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 7E4807) by Akzo
Nobel Surface Chemistry LLC, 200
South Riverside Plaza, Chicago, IL
60606. The petition requested that 40
CFR 180.1001(d) now redesignated as 40
CFR 180.920 (April 28, 2004, 69 FR
23113, FRL–7335–4) be amended by
establishing an exemption from the
requirement of a tolerance for residues
of 2-ethylhexyl glucopyranoside when
used as an inert ingredient (surfactant)
in pesticide products applied to growing
crops only. That notice included a
summary of the petition prepared by the
petitioner. There were no comments
received in response to the notice of
filing.
During its evaluation of the
information submitted by Akzo Nobel,
the Agency determined that the actual
2-ethylhexyl glucopyranosides to be
considered under PP 7E4807 are:
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- (CAS
Reg. No. 330980–61–5)and [alpha]-Dglucopyranoside, 2-ethylhexyl (CAS
Reg. No. 125590–73–0).
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
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
nature of the toxic effects caused by
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
are discussed in this unit.
The test substance for all of the
studies submitted by the petitioner for
review and evaluation was identified as
a mixture of [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl. Thus,
both chemicals were in the test
substance.
A. Acute Toxicity
The Agency’s review of the following
five acute toxicity studies and the
toxicity category classification, are
shown in Table 1. Toxicity Category I is
indicative of very high acute toxicity.
Toxicity Category IV is the Agency’s
lowest rating of acute toxicity.
TABLE 1.—ACUTE TOXICITY STUDIES
Study/Species
Results
Lethal Dose (LD)50 > 2,000
milligrams/kilogram (mg/kg) and
<5,000 mg/kg (males and females)
III
LD50 > 2380 mg/kg (males and
females)
IV
Corrosive
I
Not irritating
IV
Weak dermal sensitizer
Acute oral toxicity/rat
N/A
Acute dermal toxicity/rat
Primary eye irritation/rabbit
Primary dermal irritation/rabbit
Dermal sensitization/guinea pig
B. Mutagenicity
A Salmonella/microsome reverse gene
mutation assay (Ames Test) and an in
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vitro mammalian cytogenetics assay
were reviewed for the Agency by the
Department of Energy’s Oakridge
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National Laboratory (ORNL), and the
results of their review are presented in
Table 2.
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TABLE 2.—MUTAGENICITY STUDIES
Type of Study
Results
Salmonella/microsome reverse gene mutation assay (Ames Test)
Negative. No increase in the mean number of
revertants per plate with or without S9-mix, in
any tester strain either assay.
In vitro mammalian cytogenetics assay
Negative with and without activation.
C. Repeated Dose Toxicity
The repeated dose toxicity of 2ethylhexylglucoside was investigated in
a 28–day oral (gavage) toxicity study in
rats, which was also reviewed by ORNL.
Sprague-Dawley rats, were administered
doses of 0, 15, 150, or 750 mg/kg/day.
The NOAEL (no observed adverse effect
level) was determined to be 150 mg/kg/
day in females. The LOAEL (lowest
observed adverse effect level) in females
was 750 mg/kg/day in females due to
decreased food consumption and an
associated, statistically significant
reduction in overall body weight gain
(80% of weight gain of the control
group). The NOAEL in males is equal to
or greater than 750 mg/kg/day (highest
dose tested - (HDT)). A LOAEL in males
could not be determined, but would be
greater than 750 mg/kg/day. The
reduction in body weights and overall
body weight gains in the high-dose
females is likely representative of an
adverse effect of the chemicals, and not
related to a palatability problem, as the
mode of administration was gavage.
D. Reproductive Toxicity
A recently conducted one-generation
reproduction toxicity study of the two
chemicals was reviewed by ORNL. The
test substance was administered by oral
gavage to Wistar rats at doses of 0, 15,
150, or 750 mg/kg/day. The premating
period of exposure to the test substance
was ten weeks for the males and two
weeks for the females. Eight treatment
related mortalities (four males and four
females) occurred in the F0 parental
generation at the HDT, 750 mg/kg/day.
In addition, statistically significant
decreases in body weights and food
consumption of the F0 high-dose males
and females were observed during the
premating period. Clinical signs that
were increased in parental animals at
the 750 mg/kg/day dose level included
brown staining of the head, back, neck,
and/or genital region, rales, and
hunched posture (females only).
Postmortem examinations did not reveal
any biologically significant
abnormalities. The parental systemic
toxicity NOAEL is 150 mg/kg/day. The
parental toxicity LOAEL is 750 mg/kg/
day based on statistically significant
decreases in body weights and decreases
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in food consumption of the F0 males
and females, increased mortality, and
clinical signs.
There were no treatment-related
effects on health, viability, body weight,
and sex ratios of the F1 offspring. The
offspring systemic toxicity NOAEL
would be equal to or greater than 750
mg/kg/day. A LOAEL is not identified
but would be greater than 750 mg/kg/
day. Mating performance and fertility of
males and females of the F0 parental
generation were not adversely affected.
The NOAEL for reproductive toxicity is
equal to or greater than 750 mg/kg/day
(HDT). A LOAEL is not identified but
would be greater than 750 mg/kg/day.
E. Metabolism
The petitioner submitted an article
from open literature on metabolism
studies in mice conducted with the
structurally-related chemicals (octyl bD-glucoside, dodecyl b-D-maltoside, and
hexadecyl b-D-glucoside). The
radiolabeled test material consisted of
octyl b-D-[U-14C]glucoside, [l14C]dodecyl b-D-maltoside and [l14C]hexadecyl b-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.
For [alpha]-D-glucopyranoside, 2ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl, the long
chain alcohol formed via hydrolysis
would be 2-ethylhexanol.
F. Toxicity of 2-EthylHexanol
Since 2-ethylhexanol is the alcohol
formed via hydrolysis, toxicity studies
performed using 2-ethylhexanol as the
test substance can be used to further
understand the toxicity of [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl.
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Under a Toxic Substances Control Act
(TSCA) test rule, toxicity studies
performed using 2-ethylhexanol were
submitted to the Agency’s Office of
Pollution Prevention and Toxics
(OPPT). Reviews of two carcinogenicity
studies (mouse and rat) and a dermal
developmental toxicity study are posted
on the Agency’s website (see https://
www.epa.gov/opptintr/chemtest/
ethylhex.htm). The conclusions of the
Agency’s reviewers were that 2ethylhexanol is not carcinogenic in the
mouse under the conditions of the
study, and that there is no evidence of
carcinogenicity in the rat at any dose
level tested. In the developmental
toxicity study there was no evidence of
developmental toxicity at any dose
level. The dermal developmental
NOAEL is therefore equal to or greater
than the HDT, 3.0 milliliter (mL)/kg/day
or 2,520 mg/kg/day. Maternal effects
(reduced weight gain) were noted at the
3.0 mL/kg/day dose level. Exfoliation
occurred at the application site at the
1.0 mL/kg/day dose level. The maternal
NOAEL is 0.3 mL/kg/day or 252 mg/kg/
day.
G. Conclusions
Acute toxicity studies on a mixture of
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
indicate that these two chemicals are of
low acute oral and dermal toxicity, are
a non-irritant to the skin, but a weak
sensitizer. The chemicals are severe eye
irritants.
Metabolism studies on structurallyrelated chemicals indicate that the body
can effectively metabolize these two
chemicals to water-soluble substances
(predominantly sugar and 2ethylhexanol) that are readily excreted
from the body.
A predominant effect in both the
repeated dose toxicity study and the
one-generation reproductive toxicity
study is decreased weight gain at the
750 mg/kg/day dose level. Considering
both of these studies, the NOAEL for
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
is 150 mg/kg/day. In the one-generation
reproductive study using [alpha]-D-
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glucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl as the
test substance, both the offspring
systemic toxicity NOAEL and the
NOAEL for reproductive toxicity is
equal to or greater than 750 mg/kg/day
(HDT).
[alpha]-D-glucopyranoside, 2ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl were not
mutagenic in either of the two
mutagenicity assays.
Given the relationship of 2ethylhexanol as a metabolite of the
mammalian body’s metabolism of these
two chemicals, data on 2-ethylhexanol
can be used to judge that [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl are not
carcinogens or developmentally toxic.
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 nonoccupational 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
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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 [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl.
2. Drinking water exposure. EPA has
estimated the fate and biodegradation
properties of the larger of the two
ethylhexyl glucosides that are the
subject of this final rule using EPI-Suite
and the PBT profiler. Screening-level
tools such as EPI-Suite and the PBT
profiler are deliberately designed to be
easy-to-use, fast, and conservative in
nature. (see https://pbtprofiler.net and
https://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 the ethylhexyl
glucosides are soluble in water, but are
expected to degrade rapidly in the
environment. Degradation begins within
a matter of hours or days, with these
primary degradation products including
glucose and 2-ethylhexanol which will
continue to degrade. Ultimate
degradation (to carbon dioxide and
water) occurs in days to weeks. These
glucoside chemicals are soluble, nonvolatile, and mobile. Leaching to ground
water is likely in highly porous soils,
but mitigated in other soils due to the
rapid biodegradation. Migration to
ground water drinking water sources is
possible, but will be limited by the
rapid primary degradation.
Based on the available modeling (EPISuite models and the PBT profiler), the
Agency judges that it is very unlikely
that these glucosides 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
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
in sources of drinking water is very
unlikely.
B. Other Non-Occupational Exposure
Chemicals such as [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl are
used in dishwashing detergents,
cleaning products and degreasers. A
typical concentration in such a product
would be less than 15%.
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VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance or tolerance exemption, the
Agency consider ‘‘available
information’’ concerning the cumulative
effects of a particular chemical’s
residues and ‘‘other substances that
have a common mechanism of toxicity.’’
Unlike other pesticide chemicals 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 as to [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl and any
other substances. [alpha]-DGlucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl do not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has not assumed that
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
have 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 https://
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. [alpha]-D-glucopyranoside, 2ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl are
readily metabolized in the mammalian
body to sugars and 2-ethylhexanol.
Information on the metabolite 2ethylhexanol indicates that there is no
increased susceptibility. In the
reproductive study conducted using
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
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both the offspring systemic toxicity
NOAEL and the NOAEL for
reproductive toxicity is equal to or
greater than 750 mg/kg/day (HDT).
Given the parental NOAEL of 150 mg/
kg/day, there is no increased
susceptibility. A safety factor analysis
has not been used to assess the risk of
[alpha]-D-glucopyranoside, 2-ethylhexyl
6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2ethylhexyl. 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
on [alpha]-D-glucopyranoside, 2ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl, and on
their metabolite 2-ethylhexanol, and on
the modeled exposure levels which are
well-below any dose level at which an
adverse effect is expected, EPA
concludes that there is a reasonable
certainty of no harm from aggregate
exposure to residues of [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- (CAS Reg.
No. 330980–61–5) and [alpha]-Dglucopyranoside, 2-ethylhexyl (CAS
Reg. No. 125590–73–0). EPA finds that
establishing exemptions from the
requirement of a tolerance for [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- (CAS Reg.
No. 330980–61–5)and [alpha]-Dglucopyranoside, 2-ethylhexyl (CAS
Reg. No. 125590–73–0) 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 alpha]-D-glucopyranoside, 2ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-Dglucopyranoside, 2-ethylhexyl for
endocrine effects may be required.
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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 alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl
D. International Tolerances
The Agency is not aware of any
country requiring a tolerance for alpha]D-glucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- and [alpha]D-glucopyranoside, 2-ethylhexyl nor
have any CODEX Maximum Residue
Levels (MRLs) been established for any
food crops at this time.
X. Conclusions
Accordingly, two exemptions from
the requirement for a tolerance are
established for [alpha]-Dglucopyranoside, 2-ethylhexyl 6-O[alpha]-D glucopyranosyl- (CAS Reg.
No. 330980–61–5) and [alpha]-Dglucopyranoside, 2-ethylhexyl (CAS
Reg. No. 125590–73–0).
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
PO 00000
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54279
OPP–2002–0166 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
your request to the Office of the Hearing
Clerk in Suite 350, 1099 14 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–2002–0166, 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 email 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
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Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations
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
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15:56 Sep 13, 2005
Jkt 205001
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.
PO 00000
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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.
Dated: September 2, 2005
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920 the table is amended
by adding alphabetically the following
inert ingredients to read as follows:
I
§ 180.920 Inert ingredients used preharvest;
exemptions from the requirement of a
tolerance.
*
*
*
*
*
Inert ingredients
*
*
*
[alpha]-D-glucopyranoside, 2ethylhexyl 6-O[alpha]-D
glucopyranosyl(CAS Reg. No.
330980–61–5)
*
*
*
[alpha]-D-glucopyranoside, 2ethylhexyl (CAS
Reg. No. 125590–
73–0)
*
*
*
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Uses
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*
*
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*
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*
.............. Surfactant
*
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*
Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations
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[FR Doc. 05–18244 Filed 9–13–05; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[OPP–2003–0362; FRL–7729–7]
Alkyl (C10–C16) Polyglycosides;
Exemptions from the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
two exemptions from the requirement of
a tolerance for residues of alkyl (C10–
C16) polyglycosides also known as Dglucopyranose, oligomeric, C10–C16alkyl 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 https://
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
VerDate Aug<18>2005
15:56 Sep 13, 2005
Jkt 205001
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
(https://www.epa.gov/edocket/), you may
access this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available at E-CFR
Beta Site Two at https://
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.
PO 00000
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54281
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
E:\FR\FM\14SER1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Rules and Regulations]
[Pages 54275-54281]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18244]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0166; FRL-7729-6]
Ethylhexyl Glucopyranosides; Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes two exemptions from the
requirement of a tolerance for residues of [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and [alpha]-D-
glucopyranoside, 2-ethylhexyl when used as inert ingredients in or on
growing crops. Akzo Nobel Surface Chemistry LLC 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 these two ethylhexyl glucopyranoside chemicals.
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-2002-0166. All documents in the docket
are listed in the EDOCKET index at https://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 (https://www.epa.gov/edocket/), you
may
[[Page 54276]]
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of August 7, 2002 (67 FR 51260) (FRL-7190-
4), 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 7E4807) by Akzo Nobel Surface
Chemistry LLC, 200 South Riverside Plaza, Chicago, IL 60606. The
petition requested that 40 CFR 180.1001(d) now redesignated as 40 CFR
180.920 (April 28, 2004, 69 FR 23113, FRL-7335-4) be amended by
establishing an exemption from the requirement of a tolerance for
residues of 2-ethylhexyl glucopyranoside when used as an inert
ingredient (surfactant) in pesticide products applied to growing crops
only. That notice included a summary of the petition prepared by the
petitioner. There were no comments received in response to the notice
of filing.
During its evaluation of the information submitted by Akzo Nobel,
the Agency determined that the actual 2-ethylhexyl glucopyranosides to
be considered under PP 7E4807 are: [alpha]-D-glucopyranoside, 2-
ethylhexyl 6-O-[alpha]-D glucopyranosyl- (CAS Reg. No. 330980-61-5)and
[alpha]-D-glucopyranoside, 2-ethylhexyl (CAS Reg. No. 125590-73-0).
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 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 nature of the toxic effects caused
by [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl are
discussed in this unit.
The test substance for all of the studies submitted by the
petitioner for review and evaluation was identified as a mixture of
[alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
and [alpha]-D-glucopyranoside, 2-ethylhexyl. Thus, both chemicals were
in the test substance.
A. Acute Toxicity
The Agency's review of the following five acute toxicity studies
and the toxicity category classification, are shown in Table 1.
Toxicity Category I is indicative of very high acute toxicity. Toxicity
Category IV is the Agency's lowest rating of acute toxicity.
Table 1.--Acute Toxicity Studies
----------------------------------------------------------------------------------------------------------------
Study/Species Results Toxicity Category
----------------------------------------------------------------------------------------------------------------
Acute oral toxicity/rat Lethal Dose (LD)50 > 2,000 III
milligrams/kilogram (mg/kg) and
<5,000 mg/kg (males and females)
------------------------------------------------------------------------------
Acute dermal toxicity/rat LD50 > 2380 mg/kg (males and IV
females)
------------------------------------------------------------------------------
Primary eye irritation/rabbit Corrosive I
------------------------------------------------------------------------------
Primary dermal irritation/rabbit Not irritating IV
------------------------------------------------------------------------------
Dermal sensitization/guinea pig Weak dermal sensitizer N/A
----------------------------------------------------------------------------------------------------------------
B. Mutagenicity
A Salmonella/microsome reverse gene mutation assay (Ames Test) and
an in vitro mammalian cytogenetics assay were reviewed for the Agency
by the Department of Energy's Oakridge National Laboratory (ORNL), and
the results of their review are presented in Table 2.
[[Page 54277]]
Table 2.--Mutagenicity Studies
----------------------------------------------------------------------------------------------------------------
Type of Study Results
----------------------------------------------------------------------------------------------------------------
Salmonella/microsome reverse gene mutation assay (Ames Test) Negative. No increase in the mean number of
revertants per plate with or without S9-mix,
in any tester strain either assay.
----------------------------------------------------------------------------------------------------------------
In vitro mammalian cytogenetics assay Negative with and without activation.
----------------------------------------------------------------------------------------------------------------
C. Repeated Dose Toxicity
The repeated dose toxicity of 2-ethylhexylglucoside was
investigated in a 28-day oral (gavage) toxicity study in rats, which
was also reviewed by ORNL. Sprague-Dawley rats, were administered doses
of 0, 15, 150, or 750 mg/kg/day. The NOAEL (no observed adverse effect
level) was determined to be 150 mg/kg/day in females. The LOAEL (lowest
observed adverse effect level) in females was 750 mg/kg/day in females
due to decreased food consumption and an associated, statistically
significant reduction in overall body weight gain (80% of weight gain
of the control group). The NOAEL in males is equal to or greater than
750 mg/kg/day (highest dose tested - (HDT)). A LOAEL in males could not
be determined, but would be greater than 750 mg/kg/day. The reduction
in body weights and overall body weight gains in the high-dose females
is likely representative of an adverse effect of the chemicals, and not
related to a palatability problem, as the mode of administration was
gavage.
D. Reproductive Toxicity
A recently conducted one-generation reproduction toxicity study of
the two chemicals was reviewed by ORNL. The test substance was
administered by oral gavage to Wistar rats at doses of 0, 15, 150, or
750 mg/kg/day. The premating period of exposure to the test substance
was ten weeks for the males and two weeks for the females. Eight
treatment related mortalities (four males and four females) occurred in
the F0 parental generation at the HDT, 750 mg/kg/day. In addition,
statistically significant decreases in body weights and food
consumption of the F0 high-dose males and females were observed during
the premating period. Clinical signs that were increased in parental
animals at the 750 mg/kg/day dose level included brown staining of the
head, back, neck, and/or genital region, rales, and hunched posture
(females only). Postmortem examinations did not reveal any biologically
significant abnormalities. The parental systemic toxicity NOAEL is 150
mg/kg/day. The parental toxicity LOAEL is 750 mg/kg/day based on
statistically significant decreases in body weights and decreases in
food consumption of the F0 males and females, increased mortality, and
clinical signs.
There were no treatment-related effects on health, viability, body
weight, and sex ratios of the F1 offspring. The offspring systemic
toxicity NOAEL would be equal to or greater than 750 mg/kg/day. A LOAEL
is not identified but would be greater than 750 mg/kg/day. Mating
performance and fertility of males and females of the F0 parental
generation were not adversely affected. The NOAEL for reproductive
toxicity is equal to or greater than 750 mg/kg/day (HDT). A LOAEL is
not identified but would be greater than 750 mg/kg/day.
E. 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. For [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-
[alpha]-D glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl,
the long chain alcohol formed via hydrolysis would be 2-ethylhexanol.
F. Toxicity of 2-EthylHexanol
Since 2-ethylhexanol is the alcohol formed via hydrolysis, toxicity
studies performed using 2-ethylhexanol as the test substance can be
used to further understand the toxicity of [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and [alpha]-D-
glucopyranoside, 2-ethylhexyl.
Under a Toxic Substances Control Act (TSCA) test rule, toxicity
studies performed using 2-ethylhexanol were submitted to the Agency's
Office of Pollution Prevention and Toxics (OPPT). Reviews of two
carcinogenicity studies (mouse and rat) and a dermal developmental
toxicity study are posted on the Agency's website (see https://
www.epa.gov/opptintr/chemtest/ethylhex.htm). The conclusions of the
Agency's reviewers were that 2-ethylhexanol is not carcinogenic in the
mouse under the conditions of the study, and that there is no evidence
of carcinogenicity in the rat at any dose level tested. In the
developmental toxicity study there was no evidence of developmental
toxicity at any dose level. The dermal developmental NOAEL is therefore
equal to or greater than the HDT, 3.0 milliliter (mL)/kg/day or 2,520
mg/kg/day. Maternal effects (reduced weight gain) were noted at the 3.0
mL/kg/day dose level. Exfoliation occurred at the application site at
the 1.0 mL/kg/day dose level. The maternal NOAEL is 0.3 mL/kg/day or
252 mg/kg/day.
G. Conclusions
Acute toxicity studies on a mixture of [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and [alpha]-D-
glucopyranoside, 2-ethylhexyl indicate that these two chemicals are of
low acute oral and dermal toxicity, are a non-irritant to the skin, but
a weak sensitizer. The chemicals are severe eye irritants.
Metabolism studies on structurally-related chemicals indicate that
the body can effectively metabolize these two chemicals to water-
soluble substances (predominantly sugar and 2-ethylhexanol) that are
readily excreted from the body.
A predominant effect in both the repeated dose toxicity study and
the one-generation reproductive toxicity study is decreased weight gain
at the 750 mg/kg/day dose level. Considering both of these studies, the
NOAEL for [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl is 150 mg/
kg/day. In the one-generation reproductive study using [alpha]-D-
[[Page 54278]]
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl as the test substance, both the
offspring systemic toxicity NOAEL and the NOAEL for reproductive
toxicity is equal to or greater than 750 mg/kg/day (HDT).
[alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl were not
mutagenic in either of the two mutagenicity assays.
Given the relationship of 2-ethylhexanol as a metabolite of the
mammalian body's metabolism of these two chemicals, data on 2-
ethylhexanol can be used to judge that [alpha]-D-glucopyranoside, 2-
ethylhexyl 6-O-[alpha]-D glucopyranosyl- and [alpha]-D-glucopyranoside,
2-ethylhexyl are not carcinogens or developmentally toxic.
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 [alpha]-D-
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl.
2. Drinking water exposure. EPA has estimated the fate and
biodegradation properties of the larger of the two ethylhexyl
glucosides that are the subject of this final rule using EPI-Suite and
the PBT profiler. Screening-level tools such as EPI-Suite and the PBT
profiler are deliberately designed to be easy-to-use, fast, and
conservative in nature. (see https://pbtprofiler.net and https://
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 the ethylhexyl glucosides are soluble in
water, but are expected to degrade rapidly in the environment.
Degradation begins within a matter of hours or days, with these primary
degradation products including glucose and 2-ethylhexanol which will
continue to degrade. Ultimate degradation (to carbon dioxide and water)
occurs in days to weeks. These glucoside chemicals 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. Migration to ground water drinking water sources is
possible, but will be limited by the rapid primary degradation.
Based on the available modeling (EPI-Suite models and the PBT
profiler), the Agency judges that it is very unlikely that these
glucosides 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 [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl in sources
of drinking water is very unlikely.
B. Other Non-Occupational Exposure
Chemicals such as [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-
[alpha]-D glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl
are used in dishwashing detergents, cleaning products and degreasers. A
typical concentration in such a product would be less than 15%.
VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.''
Unlike other pesticide chemicals 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 as to [alpha]-D-
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl and any other substances.
[alpha]-D-Glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
and [alpha]-D-glucopyranoside, 2-ethylhexyl do not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that [alpha]-D-
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl have 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
https://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. [alpha]-D-
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl are readily metabolized in the
mammalian body to sugars and 2-ethylhexanol. Information on the
metabolite 2-ethylhexanol indicates that there is no increased
susceptibility. In the reproductive study conducted using [alpha]-D-
glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and
[alpha]-D-glucopyranoside, 2-ethylhexyl
[[Page 54279]]
both the offspring systemic toxicity NOAEL and the NOAEL for
reproductive toxicity is equal to or greater than 750 mg/kg/day (HDT).
Given the parental NOAEL of 150 mg/kg/day, there is no increased
susceptibility. A safety factor analysis has not been used to assess
the risk of [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D
glucopyranosyl- and [alpha]-D-glucopyranoside, 2-ethylhexyl. 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 on [alpha]-D-glucopyranoside,
2-ethylhexyl 6-O-[alpha]-D glucopyranosyl- and [alpha]-D-
glucopyranoside, 2-ethylhexyl, and on their metabolite 2-ethylhexanol,
and on the modeled exposure levels which are well-below any dose level
at which an adverse effect is expected, EPA concludes that there is a
reasonable certainty of no harm from aggregate exposure to residues of
[alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
(CAS Reg. No. 330980-61-5) and [alpha]-D-glucopyranoside, 2-ethylhexyl
(CAS Reg. No. 125590-73-0). EPA finds that establishing exemptions from
the requirement of a tolerance for [alpha]-D-glucopyranoside, 2-
ethylhexyl 6-O-[alpha]-D glucopyranosyl- (CAS Reg. No. 330980-61-5)and
[alpha]-D-glucopyranoside, 2-ethylhexyl (CAS Reg. No. 125590-73-0) 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
alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
and [alpha]-D-glucopyranoside, 2-ethylhexyl 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
alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
and [alpha]-D-glucopyranoside, 2-ethylhexyl
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-[alpha]-D glucopyranosyl-
and [alpha]-D-glucopyranoside, 2-ethylhexyl nor have any CODEX Maximum
Residue Levels (MRLs) been established for any food crops at this time.
X. Conclusions
Accordingly, two exemptions from the requirement for a tolerance
are established for [alpha]-D-glucopyranoside, 2-ethylhexyl 6-O-
[alpha]-D glucopyranosyl- (CAS Reg. No. 330980-61-5) and [alpha]-D-
glucopyranoside, 2-ethylhexyl (CAS Reg. No. 125590-73-0).
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-2002-0166 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 your request to the
Office of the Hearing Clerk in Suite 350, 1099 14 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-2002-0166, 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
[[Page 54280]]
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.
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. 180.920 the table is amended by adding alphabetically the
following inert ingredients to read as follows:
Sec. 180.920 Inert ingredients used preharvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
[alpha]-D-glucopyranoside, 2- .................. Surfactant
ethylhexyl 6-O-[alpha]-D
glucopyranosyl- (CAS Reg. No.
330980-61-5)
* * * * * * *
[alpha]-D-glucopyranoside, 2- .................. Surfactant
ethylhexyl (CAS Reg. No. 125590-
73-0)
* * * * * * *
------------------------------------------------------------------------
[[Page 54281]]
* * * * *
[FR Doc. 05-18244 Filed 9-13-05; 8:45 am]
BILLING CODE 6560-50-S
