[Federal Register Volume 70, Number 177 (Wednesday, September 14, 2005)]
[Rules and Regulations]
[Pages 54275-54281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18244]


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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.

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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 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: [email protected].

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

[[Page 54276]]

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 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
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              Study/Species                             Results                        Toxicity Category
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Acute oral toxicity/rat                           Lethal Dose (LD)50 > 2,000                                 III
                                             milligrams/kilogram (mg/kg) and
                                            <5,000 mg/kg (males and females)
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Acute dermal toxicity/rat                       LD50 > 2380 mg/kg (males and                                  IV
                                                                    females)
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Primary eye irritation/rabbit                                      Corrosive                                   I
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Primary dermal irritation/rabbit                              Not irritating                                  IV
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Dermal sensitization/guinea pig                       Weak dermal sensitizer                                 N/A
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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
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                          Type of Study                                               Results
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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.
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In vitro mammalian cytogenetics assay                                      Negative with and without activation.
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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 http://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 http://pbtprofiler.net and 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 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 
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. [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: [email protected]. 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