Federal Register / Vol. 78, No. 212 / Friday, November 1, 2013 / Rules and Regulations 65561 

disapprove Florida’s submission related 

to these requirements. With the 

exceptions noted above FDEP has 

addressed the elements of the CAA 

110(a)(1) and (2) SIP requirements 

pursuant to section 110 of the CAA to 

ensure that the 2008 8-hour ozone 

NAAQS are implemented, enforced, and 

maintained in Florida. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

Act and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this proposed 

action merely approves state law as 

meeting federal requirements and does 

not impose additional requirements 

beyond those imposed by State law. For 

that reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this proposed rule does not 

have tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the State, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: October 21, 2013. 

Beverly H. Banister 

Acting Regional Administrator, Region 4. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart K—Florida 

■ 2. Section 52.520(e), is amended by 

adding a new entry ‘‘110(a)(1) and (2) 

Infrastructure Requirements for the 2008 

8-Hour Ozone National Ambient Air 

Quality Standards’’ at the end of the 

table to read as follows: 

§ 52.520 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED FLORIDA NON-REGULATORY PROVISIONS

Provision State effective 

date 

EPA approval 

date 

Federal Register 

notice Explanation 

*******

110(a)(1) and (2) Infrastructure 

Requirements for the 2008 8- 

Hour Ozone National Ambient 

Air Quality Standards.

10/31/2011 11/1/13 [Insert citation of publication].With the exception of section 110(a)(2)(D)(i)(I) concerning interstate transport; section 

110(a)(2)(D)(i)(II) concerning visibility requirements; and the portions of sections 110(a)(2)(C), 

prong 3 of 110(a)(2)(D)(i), and 110(a)(2)(J) related to the regulation of GHG emissions, which 

are being disapproved. 

■ 3. Section 52.522 is amended by 

designating the existing paragraph as 

paragraph (a) and adding paragraph (b) 

to read as follows: 

§ 52.522 Approval status. 

(a) * * * 

(b) Disapproval. Submittal from the 

State of Florida, through the Florida 

Department of Environmental Protection 

(FDEP) on October 31, 2011, to address 

the Clean Air Act (CAA) sections 

110(a)(2)(C), 110(a)(2)(D)(i)(II), and 

110(a)(2)(J) for the 2008 8-hour Ozone 

National Ambient Air Quality Standards 

related to prevention of significant 

deterioration (PSD) requirements for the 

regulation of greenhouse gas emissions. 

EPA is disapproving FDEP’s submittal 

with respect to the PSD requirements of 

CAA sections 110(a)(2)(C), 

110(a)(2)(D)(i)(II), and 110(a)(2)(J) for the 

2008 8-hour Ozone National Ambient 

Air Quality Standards related to PSD 

requirements for the regulation of 

greenhouse gas emissions. 

[FR Doc. 2013–25985 Filed 10–31–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0165; FRL–9901–95] 

D-Glucopyranose, oligomeric, decyl 

octyl glycosides; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 


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tolerance for residues of DGlucopyranose, oligomeric, decyl octyl 

glycosides when used as an inert 

ingredient (surfactant) in antimicrobial 

formulations (food-contact surface 

sanitizing solutions) applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils. 

Lewis & Harrison, on behalf of BASF 

Corporation, submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of 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, decyl octyl glycosides. 

DATES: This regulation is effective 

November 1, 2013. Objections and 

requests for hearings must be received 

on or before December 31, 2013, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0165, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0165 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before December 31, 2013. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0165, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/

dockets. 

II. Petition for Exemption 

In the Federal Register of June 5, 2013 

(78 FR 33785) (FRL–9386–2), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP IN– 

10545) by Lewis & Harrison, LLC, 122 

C St. NW., Suite 740, Washington, DC 

20001 on behalf of BASF Corporation, 

100 Park Ave., Florham Park, NJ 07932. 

The petition requested that 40 CFR 

180.940(a) be amended by establishing 

an exemption from the requirement of a 

tolerance for residues of alkyl (C8-C10) 

polyglucosides (CAS Reg. No. 68515– 

73–1) when used as an inert ingredient 

(surfactant) in antimicrobial 

formulations (i.e., food contact surface 

sanitizing solutions) applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils. 

That document referenced a summary 

of the petition prepared by Lewis & 

Harrison, LLC, on behalf of BASF 

Corporation, the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

EPA is establishing a tolerance using 

a different chemical name than the one 

requested by the petitioner for the 

reasons discussed in Unit V.B. 

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. 


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IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of 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 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 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 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. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for DGlucopyranose, oligomeric, decyl octyl 

glycosides including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with DGlucopyranose, oligomeric, decyl octyl 

glycosides follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by D-Glucopyranose, oligomeric, decyl 

octyl glycosides as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

In order to make a safety finding on 

D-Glucopyranose, oligomeric, decyl 

octyl glycosides, EPA used data on the 

chemical itself and structurally similar 

chemicals—alkyl (C12-C14) 

polyglycosides and alkyl (C10-C16) 

polyglycosides (also known as Dglycopyranose, oligomeric, C10-C16- 

alkyl glycosides). These three chemicals 

differ from one another only in the 

length of the alkyl chain. Given these 

structural similarities, these chemicals 

are expected to have similar 

toxicological characteristics. Therefore, 

data on alkyl (C10-C16) polyglycosides 

and alkyl (C12-C14) polyglycosides have 

been used to make a safety finding on 

alkyl (C8-C10) polyglycosides. For ease of 

reading, alkyl polyglycosides will be 

collectively known throughout the 

document as ‘‘APG’’ with the specific 

carbon chain length identified as ‘‘(CxCx),’’ when appropriate. 

Acute studies indicate low acute oral 

and dermal toxicity. Studies using APG 

(C8-C10) did not show evidence of eye or 

skin irritation. Repeat dose studies for 

APGs include a 90-day gavage study, a 

14-day dermal, a reproduction study, 

and a developmental study. In the 90- 

day rat oral (gavage) study APG (C12-C14) 

was administered at dose levels of 0, 

250, 500, or 1,000 milligram/kilogram/

day (mg/kg/day) for 5 days/week. There 

were no treatment-related adverse 

effects on body weight, body weight 

gain, food consumption, hematological 

or clinical chemistry parameters, or 

organ weights. Adverse treatmentrelated effects were limited to irritation 

in the forestomach in both males and 

females receiving 500 or 1,000 mg/kg/

day. Effects were reversible following 

the cessation of treatment, but not 

reversible during treatment. Because 

humans do not have a forestomach that 

serves as a storage reservoir as in 

rodents, the effects seen in the rat 

forestomach are likely to be significantly 

more severe than what would be 

expected from the compound in the 

glandular stomach in humans and 

subsequently, have less relevance to 

humans. Therefore, the EPA determined 

the systemic oral toxicity NOAEL was 

1,000 mg/kg/day. A LOAEL was not 

determined. 

A 14-day dermal study on APGs (C8- 

C10) was conducted on rabbits (New 

Zealand white) at doses of 0, 60, 180, 

540, 1,500, and 3,000 mg/kg/day. While 

skin irritation was observed at doses 

above 180 mg/kg/day and changes in 

hematological and clinical parameters 

and testicular degeneration were 

observed at the dose levels of 1,500 and 

3,000 mg/kg/day, these effects are likely 

attributable to stress and inflammation 

due to the severe irritation caused by 

the test substance and therefore a 

NOAEL for systemic effects was not 

established. 

A 1-generation reproductive screening 

study on APG (C10-C16) was conducted 

on male and female rats following daily 

administration (gavage) of 100, 300, and 

1,000 mg/kg/day. No effects indicative 

of general toxicity were observed in 

parental animals. Relative and absolute 

weights of testes, epididymides, and 

seminal vesicles did not differ between 

test and control animals. No 

reproductive parameters were affected 

including mean litter weights, mean 

pup weights, sex ratios, and gestation 

periods. Pre-weaning clinical signs 

showed no treatment-related effects in 

pups, nor did necropsy reveal any 

effects in decedent or Fl pups. 

Macroscopic examination revealed no 

difference between treated and control 

animals. A NOAEL of 1,000 mg/kg/day 

for reproductive effects can be deduced. 

In a rat developmental toxicity study, 

APG (C12-C14) 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. In addition, 

there were no treatment-related 

developmental effects (e.g., external 

abnormalities, visceral abnormalities, or 

skeletal malformations/variations). 

Therefore, the developmental and 

maternal NOAEL is 1,000 mg/kg/day. A 

LOAEL was not determined. 

No immunotoxicity or neurotoxicity 

studies are available in the database; 

however, APGs (C8-C10) are unlikely to 

produce neurotoxicity or evoke 

immunological response given the lack 

of any toxicity, including any 

immunotoxicity or neurotoxicity, at 

high doses (1,000 mg/kg/day). 

Mutagenicity studies on various chain 


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lengths of APGs were negative 

indicating that APGs are not likely to be 

mutagenic. No carcinogenicity studies 

are available on APGs; however, APGs 

are not expected to be carcinogenic 

based on lack of mutagenicity, lack of 

any systemic toxicity at doses up to and 

including 1,000 mg/kg/day, and the 

rapid metabolism of these chemicals to 

sugars and alcohols and excretion from 

the body. 

B. Toxicological Points of Departure/

Levels of Concern 

Metabolism studies on structurally 

related 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. No adverse effects were seen 

any of the repeat dose studies 

conducted via the oral route of exposure 

at or above the limit dose. No endpoint 

of concern was identified based on the 

available studies in the database. 

C. Exposure Assessment 

Because no endpoint of concern was 

identified based upon available data, a 

qualitative risk assessment was 

conducted. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to D-Glucopyranose, 

oligomeric, decyl octyl glycosides, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. For purposes 

of this action, EPA qualitatively 

assessed dietary exposures from DGlucopyranose, oligomeric, decyl octyl 

glycosides as follows: 

Dietary exposure could potentially 

occur from consuming foods directly 

treated with pesticide products 

containing the inert ingredient. In 

addition, dietary exposure to APGs 

could occur as a result of contact with 

surfaces treated with antimicrobial 

formulations containing the inert 

ingredient, including food-contact 

surfaces in public eating places, dairyprocessing equipment, or foodprocessing equipment and utensils. 

Dietary exposure may also come from 

consuming animal products from 

animals exposed to the inert ingredient 

via pesticide application or from eating 

feed treated with pesticide products 

containing the inert ingredient. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to D-Glucopyranose, oligomeric, 

decyl octyl glycosides can occur by 

drinking water that has been 

contaminated by contact with pesticide 

treated areas, such as countertops. Since 

an endpoint for risk assessment was not 

identified, a quantitative dietary 

exposure assessment from drinking 

water for D-Glucopyranose, oligomeric, 

decyl octyl glycosides was not 

conducted. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). APGs are used in laundry 

detergents, hard surface and household 

cleaners, as rinse aids in dishwashers 

and in personal care products. Nondietary exposure could result from both 

pesticidal and non-pesticidal uses. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found D-Glucopyranose, 

oligomeric, decyl octyl glycosides to 

share a common mechanism of toxicity 

with any other substances, and DGlucopyranose, oligomeric, decyl octyl 

glycosides does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that D-Glucopyranose, 

oligomeric, decyl octyl glycosides does 

not 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 EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. The toxicity 

database for APGs contains several 

acute studies, a 90-day oral toxicity 

study, a 14-dermal study, a 

developmental toxicity study, and a 

reproductive screening toxicity study. 

No hazard was identified based on those 

studies. The toxicity database does not 

contain a carcinogenicity study, an 

immunotoxicity study, or a 

neurotoxicity study, but for the reasons 

stated in Unit IV.A., the Agency has 

concluded that there are no concerns for 

carcinogenicity, immunotoxicity, or 

neurotoxicity for this chemical. No 

developmental or reproductive effects 

were seen in the available studies. Thus, 

there is no residual uncertainty 

regarding prenatal and/or postnatal 

toxicity of D-Glucopyrnose, oligomeric, 

decyl octyl glycosides. 

Based on this information, there is no 

concern at this time for increased 

sensitivity to infants and children to DGlucopyrnose, oligomeric, decyl octyl 

glycosides when used as an inert 

ingredient in antimicrobial formulations 

applied to food-contact surfaces in 

public eating places, dairy-processing 

equipment, and food-processing 

equipment and utensils. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on D-Glucopyranose, 

oligomeric, decyl octyl glycosides, EPA 

has determined that there is a 

reasonable certainty that no harm to any 

population subgroup will result from 

aggregate exposure to D-Glucopyranose, 

oligomeric, decyl octyl glycosides under 

reasonably foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.940(a) for residues of DGlucopyranose, oligomeric, decyl octyl 

glycosides when used as an inert 

ingredient in in antimicrobial foodcontact surface sanitizing solutions is 

safe under FFDCA section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

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. 

B. Revisions to Petitioned-For 

Tolerances 

Alkyl (C8-C10) polyglycosides and DGlucopyranose, oligomeric, decyl octyl 

glycosides are alternate names for the 

chemical with the CAS Reg. No. 68515– 

73–1 and therefore, represent the same 

chemical. EPA is using the latter name 

because it is the one used in the 

Chemical Abstract (CA) Index and the 

one EPA has used to establish other 

exemptions from the requirement of 

tolerance for this chemical. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for DGlucopyranose, oligomeric, decyl octyl 

glycosides (CAS Reg. No. 68515–73–1) 

when used as an inert ingredient 

(surfactant) in antimicrobial 


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formulations (i.e., food contact surface 

sanitizing solutions) applied to foodcontact surfaces in public eating places, 

dairy-processing equipment, and foodprocessing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under FFDCA section 408(d) 

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 final rule has been exempted from 

review under Executive Order 12866, 

this final rule is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

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.), 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). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), 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. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled ‘‘Federalism’’ (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled ‘‘Consultation and 

Coordination with Indian Tribal 

Governments’’ (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (2 U.S.C. 

1501 et seq.). 

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) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: October 22, 2013. 

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 § 180.940, add alphabetically the 

following entry to the table in paragraph 

(a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

D-Glucopyranose, oligomeric, decyl octyl glycosides ........................................................................................... 68515–73–1 None 

* * * * * * * 

* * * * * 

[FR Doc. 2013–26241 Filed 10–31–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0589; FRL–9401–8] 

Fomesafen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fomesafen in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 1, 2013. Objections and 

requests for hearings must be received 

on or before December 31, 2013, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0589, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 


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