Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 54275 

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. 

■ 40 CFR part 52 is amended to read as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart TT—UTAH 

■ 2. Section 52.2320 is amended by 

adding paragraph (c)(61) to read as 

follows: 

§ 52.2320 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 

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. 

[FR Doc. 05–18232 Filed 9–13–05; 8:45 am] 

BILLING CODE 6560–50–P 

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]-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 

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: 

boyle.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111) 

• Animal production (NAICS code 

112) 

• Food manufacturing (NAICS code 

311) 

• Pesticide manufacturing (NAICS 

code 32532) 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Documents 

and Other Related Information? 

In addition to using EDOCKET at 

(http://www.epa.gov/edocket/), you may 

54276 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 

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]-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 Toxicity Category 

Acute oral toxicity/rat Lethal Dose (LD)50 > 2,000 

milligrams/kilogram (mg/kg) and 

<5,000 mg/kg (males and females) 

III 

Acute dermal toxicity/rat LD50 > 2380 mg/kg (males and 

females) 

IV 

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. 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 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 bD-glucoside, dodecyl b-D-maltoside, and 

hexadecyl b-D-glucoside). The 

radiolabeled test material consisted of 

octyl b-D-[U-14C]glucoside, [l- 14C]dodecyl b-D-maltoside and [l- 14C]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, 2- 

ethylhexyl 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. 

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 structurallyrelated 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]-DVerDate Aug<18>2005 15:56 Sep 13, 2005 Jkt 205001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\FR\FM\14SER1.SGM 14SER1
54278 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 

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]-Dglucopyranoside, 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]-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 

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 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, 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%. 

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 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]-Dglucopyranoside, 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 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 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]-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, 2- 

ethylhexyl 6-O-[alpha]-D 

glucopyranosyl- and [alpha]-Dglucopyranoside, 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]-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 

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 

54280 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 

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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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: 

§ 180.920 Inert ingredients used preharvest; 

exemptions from the requirement of a 

tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

[alpha]-D-glucopyranoside, 2- 

ethylhexyl 6-O- 

[alpha]-D 

glucopyranosyl- 

(CAS Reg. No. 

330980–61–5) 

.............. Surfactant 

* * * * * * * 

[alpha]-D-glucopyranoside, 2- 

ethylhexyl (CAS 

Reg. No. 125590–

73–0) 

.............. Surfactant 

* * * * * * * 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 54281 

* * * * * 

[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 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

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–C16- 

alkyl glycosides when used as an inert 

ingredient in or on growing crops, when 

applied to raw agricultural commodities 

after harvest, or to animals. Cognis 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides. 

DATES: This regulation is effective 

September 14, 2005. Objections and 

requests for hearings must be received 

on or before November 14, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit XI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2003–

0362. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn Boyle, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6304; e-mail address: 

boyle.kathryn@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111) 

• Animal production (NAICS code 

112) 

• Food manufacturing (NAICS code 

311) 

• Pesticide manufacturing (NAICS 

code 32532) 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Documents 

and Other Related Information? 

In addition to using EDOCKET at 

(http://www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of December 

10, 2003 (68 FR 68908) (FRL–7335–5), 

EPA issued a notice pursuant to section 

408 of the FFDCA, 21 U.S.C. 346a, as 

amended by the FQPA (Public Law 104–

170), announcing the filing of a 

pesticide petition (PP 4E4332) by Cognis 

Corporation, 490 Este Avenue, 

Cincinnati, OH 45232. That notice 

included a summary of the petition 

prepared by the petitioner. 

The petition requested that 40 CFR 

part 180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of alkyl (C10–C16) 

polyglycosides or polyglucosides, also 

known as D-glucopyranose, oligomeric, 

C10–C16-alkyl glycosides (CAS Reg. No. 

110615–47–9) when used as an inert 

ingredient in pesticide products. There 

were no comments received in response 

to the notice of filing. 

The Agency has determined that the 

use of D-glucopyranose, oligomeric, 

C10–C16-alkyl glycosides (CAS Reg. No. 

110615–47–9) in a pesticide product is 

as a surfactant. 

Section 408(b)(2)(A)(i) of the FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of the FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of the FFDCA requires EPA 

to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not