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 

54282 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of the FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. The 

information submitted by the petitioner 

for review and evaluation included 

information on toxicity studies 

performed on alkyl (C8–C10) 

polyglycosides, and alkyl (C12–C14) 

polyglycosides. The actual substance 

used for each test is noted below. 

An alkyl polyglycoside is created by 

combining glucose and an alcohol. 

Alkyl (C8–C10) polyglycosides and alkyl 

(C12–C14) polyglycosides are 

structurally-related to the alkyl (C10–C16) 

polyglycosides also known as Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides that is the subject of 

this final rule. These chemicals differ 

from one another only in the length of 

the alkyl chain. Given these structural 

similarities, these chemicals have 

similar toxicological characteristics. 

Two types of data were submitted by 

the petitioner: Publicly-available 

information from open literature and 

complete toxicity studies. The results of 

the existing reviews in the publiclyavailable information were extracted 

from the submitted article. The 

complete toxicity studies included two 

mutagenicity studies, a subchronic 90 

day study, and a developmental study. 

These studies were reviewed by the 

Department of Energy’s Oakridge 

National Laboratory (ORNL), and the 

results of their review are presented 

below, noted by an asterisk (*). 

A. Acute Toxicity 

TABLE 1.—ACUTE TOXICITY STUDIES

Study/Species Test Substance Results 

Acute oral toxicity/rat C8–C14 Lethal Dose (LD)50 > 5,000 

milligrams/kilogram (mg/kg) 

Acute oral toxicity/rat C12–C14 LD50 > 5,000 mg/kg 

Acute oral toxicity/rat C12–C14 LD50 > 2,000 mg/kg 

Acute dermal toxicity/rabbit C8–C10 LD50 > 2,000 mg/kg 

Acute dermal toxicity/rabbit C12–C14 LD50 > 2,000 mg/kg 

Primary eye irritation/rabbit C8–C10 No irritating effects 

Primary eye irritation/rabbit C12–C14 Irritating to the eye 

Primary dermal irritation/rabbit C8–C10 No irritating effects 

Primary dermal irritation/rabbit C12–C14 No irritating effects at concentrations 

of up to 30% 

Irritating to the skin at concentrations 

greater than 30% to 100%. 

Dermal sensitization/guinea pig C8–C10 Not a dermal sensitizer 

Dermal sensitization/guinea pig C12–C14 Not a dermal sensitizer 

TABLE 2.—MUTAGENICITY STUDIES

Type of Study Test Substance Results 

Salmonella/Escherichia reverse gene mutation assay (Ames 

Test)* C12–C14 Negative. No evidence of induced 

mutant colonies over background. 

Salmonella typhimurium reverse (Ames Test) Not specified Did not induce reverse mutations in 

the tested strains of Salmonella 

typhimurium either with or without 

metabolic activation. 

In vitro cytogenetic test in Chinese hamster V79 lung fibroblast Not specified Considered to be non-mutagenic. 

In vitro mammalian cytogenetics assay* C12–C14 Negative with and without activation. 

B. Repeated Dose Toxicity* 

In a 90–day rat oral (gavage) toxicity 

study, alkyl (C12–C14) polyglucosides 

was administered at dose levels of 0, 

250, 500, or 1,000 mg/kg/day for 5 days/ 

week. An additional high-dose group 

was treated and then had a treatmentfree period of 27 days before sacrifice. 

There were no treatment-related 

adverse effects on body weight, body 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 54283 

weight gain, food consumption, 

hematological or clinical chemistry 

parameters or organ weights in any 

group. Adverse treatment-related effects 

were limited to the forestomach in both 

males and females receiving 500 or 

1,000 mg/kg/day. After 27 days, it was 

observed that forestomach effects were 

reversible following the cessation of 

treatment, but not during treatment. 

Under the conditions of the study, the 

NOAEL (no observed adverse effect 

level) for alkyl (C12–C14) polyglucosides 

is 250 mg/kg/day. The LOAEL (lowest 

observed adverse effect level) is 500 mg/ 

kg/day based on acanthosis, 

subepithelial inflammatory edema, and 

hyperkeratosis (females only) of the 

forestomach, which did not resolve 

during the treatment period. 

C. Developmental Toxicity* 

In a rat developmental toxicity study, 

alkyl (C12–C14) polyglucosides was 

administered by gavage at dose levels of 

0, 100, 300, and 1,000 mg/kg/day on 

gestation days 6 to 15. No treatment 

related maternal deaths, clinical signs, 

or decreases in mean body weight, 

weight gain, corrected weight gain or 

gross lesions were observed in this 

study. The maternal NOAEL is equal to 

or greater than 1,000 mg/kg/day. A 

LOAEL was not determined, but would 

be greater than 1,000 mg/kg/day. 

No treatment-related effects were 

observed on any cesarean section 

parameter. No treatment-related external 

abnormalities, visceral abnormalities or 

skeletal malformations/variations, 

including the number of ossification 

sites were observed at any dose. The 

developmental NOAEL is equal to or 

greater than 1,000 mg/kg/day. A LOAEL 

was not determined, but would be 

greater than 1,000 mg/kg/day. 

D. Metabolism 

The petitioner submitted an article 

from open literature on metabolism 

studies in mice conducted with the 

structurally-related chemicals (octyl 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. 

E. Conclusions 

Acute toxicity studies on various 

chain lengths of alkyl polyglucosides 

indicate that D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides is 

likely to be of low acute oral and dermal 

toxicity. However, based on the 

surrogate data, D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides is 

likely to be an eye and dermal irritant 

when used at higher concentrations. 

Metabolism studies on structurallyrelated chemicals indicate that the body 

can effectively metabolize Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides to water-soluble 

substances (predominantly sugar and 

various alcohols) that are readily 

excreted from the body. 

In a 90–day rat oral (gavage) toxicity 

study, using alkyl (C12–C14) 

polyglucosides, the NOAEL (no 

observed adverse effect level) for alkyl 

(C12–C14) polyglucosides is 250 mg/kg/ 

day. In a rat developmental toxicity 

study using alkyl (C12–C14) 

polyglucosides, both the maternal and 

developmental NOAELs are equal to or 

greater than 1000 mg/kg/day. 

Mutagenicity studies on various chain 

lengths of alkyl polyglucosides indicate 

that D-glucopyranose, oligomeric, C10–

C16-alkyl glycosides is not likely to be 

mutagenic based on the two 

mutagenicity assays reviewed by the 

Agency and the two mutagenicity assays 

described in open literature. 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the FFDCA directs EPA 

to consider available information 

concerning exposures from the pesticide 

residue in food and all other 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 D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides. 

2. Drinking water exposure. EPA has 

estimated the fate and biodegradation 

properties of D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides 

using EPI-Suite. Screening-level tools 

such as EPI-Suite are deliberately 

designed to be easy-to-use, fast, and 

conservative in nature. (see http:// 

www.epa.gov/opptintr/exposure/docs/ 

episuite.htm). If modeled estimates do 

not indicate a level of concern, then 

higher-tiered modeling or measured 

data may not be needed. The modeled 

estimates indicate that a chemical 

substance such as D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides is 

expected to degrade rapidly in the 

environment. Degradation begins within 

a matter of hours or days, with these 

primary degradation products including 

glucose and various alcohols which will 

continue to degrade. Ultimate 

degradation (to carbon dioxide and 

water) occurs in days to weeks. These 

glycoside compounds are soluble, nonvolatile, and mobile. Leaching to ground 

water is likely in highly porous soils, 

but mitigated in other soils due to the 

rapid biodegradation. Volatilization 

from surface waters is very low. 

Migration to ground water drinking 

water sources is possible, but will be 

limited by the rapid primary 

degradation. 

Based on values estimated using the 

EPI-Suite model, it is very unlikely that 

D-glucopyranose, oligomeric, C10–C16- 

alkyl glycosides will reach either 

ground or surface water, or 

bioaccumulate in the environment. This 

conclusion is based on its rather rapid 

primary degradation (estimated to be 

hours to days), and ultimate 

biodegradation to carbon dioxide and 

water. Significant concentrations of Dglucopyranose, oligomeric, C10–C16- 

54284 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 

alkyl glycosides in sources of drinking 

water is very unlikely. 

B. Other Non-Occupational Exposure 

Various alkyl polyglucosides are used 

in glass cleaners and other household 

cleaning products, as rinse aids in dish 

washers, and in cleaning products used 

by the food industry. 

VI. Cumulative Effects 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding for Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides. D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides 

does not appear to produce any toxic 

metabolite produced by other 

substances and the overall toxicity of 

this compound is very low. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides has a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

VII. Safety Factor for Infants and 

Children 

FFDCA section 408 provides that EPA 

shall apply an additional tenfold margin 

of safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA concluded that a different margin 

of safety will be safe for infants and 

children. 

D-glucopyranose, oligomeric, C10–C16- 

alkyl glycosides is of low acute toxicity, 

and is readily metabolized in the 

mammalian body. In a developmental 

toxicity study reviewed and evaluated 

by ORNL for EPA, the developmental 

NOAEL is equal to or greater than 1,000 

mg/kg/day. Due to the expected low oral 

toxicity, a safety factor analysis has not 

been used to assess the risk of Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides. For the same reasons, 

the additional tenfold safety factor for 

the protection of infants and children is 

unnecessary. 

VIII. Determination of Safety for U.S. 

Population, and Infants and Children 

Based on the available toxicity data, 

EPA judges that D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides is a 

chemical of lower toxicity. Therefore, 

EPA concludes that there is a reasonable 

certainty of no harm from aggregate 

exposure to residues of Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides (CAS Reg. No. 110615–

47–9). EPA finds that establishing an 

exemption from the requirement of a 

tolerance for D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides 

(CAS Reg. No. 110615–47–9) will be 

safe for the general population 

including infants and children. 

IX. Other Considerations 

A. Endocrine Disruptors 

FQPA requires EPA to develop a 

screening program to determine whether 

certain substances, including all 

pesticide chemicals (both inert and 

active ingredients), ‘‘may have an effect 

in humans that is similar to an effect 

produced by a naturally occurring 

estrogen, or such other endocrine effect. 

. .’’ EPA has been working with 

interested stakeholders to develop a 

screening and testing program as well as 

a priority setting scheme. As the Agency 

proceeds with implementation of this 

program, further testing of products 

containing D-glucopyranose, oligomeric, 

C10–C16-alkyl glycosides for endocrine 

effects may be required. 

B. Analytical Method(s) 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. Existing Exemptions 

There are no existing tolerances or 

tolerance exemptions for Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides 

D. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for Dglucopyranose, oligomeric, C10–C16- 

alkyl glycosides nor have any CODEX 

Maximum Residue Levels (MRLs) been 

established for any food crops at this 

time. 

X. Conclusions 

Accordingly, an exemption from the 

requirement for a tolerance is 

established for D-glucopyranose, 

oligomeric, C10–C16-alkyl glycosides 

(CAS Reg. No. 110615-47-9). 

XI. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old FFDCA sections 408 

and 409 of the FFDCA. However, the 

period for filing objections is now 60 

days, rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2003–0362 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 14, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issue(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 54285 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit XI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2003–0362, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via 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 

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. 

54286 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Rules and Regulations 

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 § 180.910 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemption from the 

requirement of a tolerance. 

*** 

Inert ingredients Limits Uses 

* * * * * * * 

D-glucopyranose, 

oligomeric, C10–16- 

alkyl glycosides 

(CAS Reg. No. 

110615–47–9) 

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

* * * * * * * 

* * * * * 

■ 3. In § 180.930 the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemption from the requirement of 

a tolerance. 

*** 

Inert ingredients Limits Uses 

* * * * * * * 

D-glucopyranose, 

oligomeric, C10–16- 

alkyl glycosides 

(CAS Reg. No. 

110615–47–9) 

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

* * * * * * * 

* * * * * 

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

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[FRL–7968–3] 

National Priorities List for Uncontrolled 

Hazardous Waste Sites 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

(‘‘CERCLA’’ or ‘‘the Act’’), as amended, 

requires that the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (‘‘NCP’’) include a list 

of national priorities among the known 

releases or threatened releases of 

hazardous substances, pollutants, or 

contaminants throughout the United 

States. The National Priorities List 

(‘‘NPL’’) constitutes this list. The NPL is 

intended primarily to guide the 

Environmental Protection Agency 

(‘‘EPA’’ or ‘‘the Agency’’) in determining 

which sites warrant further 

investigation. These further 

investigations will allow EPA to assess 

the nature and extent of public health 

and environmental risks associated with 

the site and to determine what CERCLAfinanced remedial action(s), if any, may 

be appropriate. This rule adds seven 

new sites to the General Superfund 

Section of the NPL. 

DATES: The effective date for this 

amendment to the NCP shall be October 

14, 2005. 

ADDRESSES: For addresses for the 

Headquarters and Regional dockets, as 

well as further details on what these 

dockets contain, see section II, 

‘‘Availability of Information to the 

Public’’ in the ‘‘Supplementary 

Information’’ portion of this preamble. 

FOR FURTHER INFORMATION CONTACT: 

Terry Jeng, phone (703) 603–8852, State, 

Tribal and Site Identification Branch; 

Assessment and Remediation Division; 

Office of Superfund Remediation and 

Technology Innovation (mail code 

5204G); U.S. Environmental Protection 

Agency; 1200 Pennsylvania Avenue 

NW.; Washington, DC 20460; or the 

Superfund Hotline, phone (800) 424–

9346 or (703) 412–9810 in the 

Washington, DC, metropolitan area. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. What are CERCLA and SARA? 

B. What is the NCP? 

C. What is the National Priorities List 

(NPL)? 

D. How are Sites Listed on the NPL? 

E. What Happens to Sites on the NPL? 

F. Does the NPL Define the Boundaries of 

Sites? 

G. How are Sites Removed from the NPL? 

H. May EPA Delete Portions of Sites From 

the NPL as They Are Cleaned Up? 

I. What is the Construction Completion List 

(CCL)? 

II. Availability of Information to the Public 

A. May I Review the Documents Relevant 

to this Final Rule? 

B. What Documents are Available for 

Review at the Headquarters Docket? 

C. What Documents are Available for 

Review at the Regional Dockets? 

D. How Do I Access the Documents? 

E. How May I Obtain a Current List of NPL 

Sites? 

III. Contents of This Final Rule 

A. Additions to the NPL 

B. Site Name Change 

C. What did EPA Do with the Public 

Comments It Received? 

IV. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

1. What is Executive Order 12866? 

2. Is this Final Rule Subject to Executive 

Order 12866 Review? 

B. Paperwork Reduction Act 

1. What is the Paperwork Reduction Act? 

2. Does the Paperwork Reduction Act 

Apply to This Final Rule? 

C. Regulatory Flexibility Act 

1. What is the Regulatory Flexibility Act? 

2. How Has EPA Complied with the 

Regulatory Flexibility Act? 

D. Unfunded Mandates Reform Act 

1. What is the Unfunded Mandates Reform 

Act (UMRA)? 

2. Does UMRA Apply to This Final Rule? 

E. Executive Order 13132: Federalism 

1. What Is Executive Order 13132 and Is It 

Applicable to This Final Rule? 

F. Executive Order 13175: Consultation 

and Coordination with Indian Tribal 

Governments 

1. What is Executive Order 13175? 

2. Does Executive Order 13175 Apply to 

This Final Rule? 

G. Executive Order 13045: Protection of 

Children from Environmental Health and 

Safety Risks 

1. What is Executive Order 13045? 

2. Does Executive Order 13045 Apply to 

This Final Rule? 

H. Executive Order 13211 

1. What is Executive Order 13211? 

2. Is this Rule Subject to Executive Order 

13211? 

I. National Technology Transfer and 

Advancement Act 

1. What is the National Technology 

Transfer and Advancement Act? 

2. Does the National Technology Transfer 

and Advancement Act Apply to this 

Final Rule? 

J. Possible Changes to the Effective Date of 

the Rule 

1. Has EPA Submitted This Rule to 

Congress and the General Accounting 

Office? 

2. Could the Effective Date of This Final 

Rule Change? 

3. What Could Cause a Change in the 

Effective Date of This Rule? 

I. Background 

A. What Are CERCLA and SARA? 

In 1980, Congress enacted the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act, 42 U.S.C. 9601–9675 (‘‘CERCLA’’ or 

‘‘the Act’’), in response to the dangers of 

uncontrolled releases or threatened 

releases of hazardous substances, and 

releases or substantial threats of releases 

into the environment of any pollutant or 

contaminant which may present an