Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations 31481 

finality and regulatory repose, given that 

CAA section 112(c)(6) itself does not 

require the EPA to issue any final notice 

or take any other final action that 

functions to re-open previously 

promulgated standards that are credited 

to meeting the 90 percent requirement. 

If, in fact, additional control of HAP, 

including CAA section 112(c)(6) HAP, is 

appropriate because of remaining risk or 

newly available control technologies or 

practices, the CAA addresses that 

possibility by requiring review of CAA 

section 112(d)(2) standards pursuant to 

CAA sections 112(d)(6) and (f)(2). Thus, 

the commenter has had and will have 

additional opportunities to address 

whether additional control of the 

section 112(c)(6) HAP is warranted. 

V. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action and was, therefore, not 

submitted to the Office of Management 

and Budget (OMB) for review. 

B. Paperwork Reduction Act (PRA) 

This action does not impose an 

information collection burden under the 

PRA because it does not contain any 

information collection activities. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA. This action will not 

impose any requirements on small 

entities. This action does not alter any 

of the standards discussed in this 

document. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain any 

unfunded mandate as described in 

UMRA, 2 U.S.C. 1531–1538 and does 

not significantly or uniquely affect small 

governments. The action imposes no 

enforceable duty on any state, local or 

tribal governments or the private sector. 

E. Executive Order 13132: Federalism 

This action does not have federalism 

implications. It will not 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. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175. This action does not 

materially alter the stringency of any 

standards discussed in this document. 

Thus, Executive Order 13175 does not 

apply to this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

This action is not subject to Executive 

Order 13045 because the EPA does not 

believe the environmental health risks 

or safety risks addressed by this action 

present a disproportionate risk to 

children. A health and risk assessment 

was not performed for this action 

because it does not alter any of the 

regulations discussed in this action. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211, because it is not a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act 

This rulemaking does not involve 

technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes the human health or 

environmental risk addressed by this 

action will not have potential 

disproportionately high and adverse 

human health or environmental effects 

on minority, low income or indigenous 

populations because it does not affect 

the level of protection provided to 

human health or the environment. An 

environmental justice evaluation was 

not performed for this action because it 

does not alter any of the regulations 

discussed in this action. 

K. Congressional Review Act (CRA) 

This action is subject to the CRA, and 

the EPA will submit a rule report to 

each House of the Congress and to the 

Comptroller General of the United 

States. This action is not a ‘‘major rule’’ 

as defined by 5 U.S.C. 804(2). 

Dated: May 22, 2015. 

Gina McCarthy, 

Administrator. 

[FR Doc. 2015–13500 Filed 6–2–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0678; FRL–9927–19] 

Alkyl (C8–20) Polyglucoside Esters; 

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 

tolerance for residues of Dglucopyranose, oligomeric, 6- 

(dihydrogen citrates), C8–20 branched 

and linear alkyl glycosides, sodium 

salts; D-glucopyranose, oligomeric, 6- 

(hydrogen sulfosuccinates), C8–20

branched and linear alkyl glycosides, 

sodium salts; and D-glucopyranose, 

oligomeric, lactates, C8–20 branched and 

linear alkyl glycosides when used as an 

inert ingredients (surfactants) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest. Lamberti 

USA, Inc. 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, 6-(dihydrogen citrates), C8–20

branched and linear alkyl glycosides, 

sodium salts: D-glucopyranose, 

oligomeric, 6-(hydrogen 

sulfosuccinates), C8–20 branched and 

linear alkyl glycosides, sodium salts; 

and D-glucopyranose, oligomeric, 

lactates, C8–20 branched and linear alkyl 

glycosides. 

DATES: This regulation is effective June 

3, 2015. Objections and requests for 

hearings must be received on or before 

August 3, 2015, 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–2014–0678, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 


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31482 Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton 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: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main 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 Publishing 

Office’s e-CFR site at http://

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

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2014–0678 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 August 3, 2015. 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– 

2014–0678, 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 October 15, 

2014 (79 FR 61844) (FRL–9917–24), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10675) by Lamberti 

USA, Inc., 161 Washington St., 

Conshohocken, PA 19428. The petition 

requested that 40 CFR 180.910 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of D-glucopyranose, 

oligomeric, 6-(dihydrogen citrates), C8–20

branched and linear alkyl glycosides, 

sodium salts (CAS Reg. No. 1079993– 

97–7); D-glucopyranose, oligomeric, 6- 

(hydrogen sulfosuccinates), C8–20

branched and linear alkyl glycosides, 

sodium salts (CAS Reg. No. 1079993– 

92–2); and D-glucopyranose, oligomeric, 

lactates, C8–20 branched and linear alkyl 

glycosides (CAS Reg. No. 1079993–94– 

4) (hereafter referred to in this 

document as alkyl polyglucoside (C8–20) 

esters or AGEs) when used as inert 

ingredients (surfactants) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities. That 

document referenced a summary of the 

petition prepared by Lamberti USA Inc., 

the petitioner, which is available in the 

docket, http://www.regulations.gov. One 

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit V.C. 

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. 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. . . .’’ 


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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 alkyl 

polyglucoside (C8–20) esters including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with alkyl polyglucoside 

(C8–20) esters 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 alkyl polyglucoside (C8–20) esters as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. Limited toxicity data are available 

on D-glucopyranose, oligomeric, 6- 

(dihydrogen citrates), C8–20 branched 

and linear alkyl glycosides, sodium 

salts); D-glucopyranose, oligomeric, 6- 

(hydrogen sulfosuccinates), C8–20

branched and linear alkyl glycosides, 

sodium salts; and D-glucopyranose, 

oligomeric, lactates, C8–20 branched and 

linear alkyl glycosides. The 

alkylpolyglucoside (C8–C20) esters are 

reaction products of glucose and fatty 

acids in which the alcohol moiety is 

attached to the polyglucoside by a bglucosides linkage. The toxicity profile 

of these substances is based upon data 

from other, related alkyl polyglucoside 

esters sharing similar physical and 

chemical characteristics as well as 

expected toxicity as well as AGE 

metabolites lactic acid, citric acid and 

disodium sulfosuccinate. 

AGEs have low acute toxicity via the 

oral route (oral LD50 > 5,000 milligram/ 

kilogram (mg/kg)). There is no available 

data regarding acute exposure via the 

dermal, eye or inhalation routes. 

In a combined repeated dose toxicity 

study with the reproduction/

developmental toxicity screening test in 

rats (OCSPP Guideline 870.3650 study), 

there were no observed adverse effects 

for parental systemic or reproductive/

developmental toxicity at 1,000 mg/kg/ 

day. 

A 2-year chronic oral study in rats 

treated with citric acid was available for 

review. Rats were administered 5 

percent or 3 percent citric acid (approx. 

2,000 or 1,200 mg/kg/day) in the diet. 

There were no adverse effects observed 

at 2,000 mg/kg/day. Chronic studies 

were also available for the rabbit and 

dog. There were no adverse effects 

observed in either study at doses up to 

1,500 and 1,400 mg/kg/day, 

respectively. 

Neurotoxicity studies with AGEs were 

not available for review. However, 

neurotoxicity was not observed in the 

combined repeated dose toxicity study 

with the reproduction/developmental 

toxicity screening test at concentrations 

as high as 1,000 mg/kg/day (limit dose). 

Mutagenicity studies on several 

surrogate chemicals did not indicate 

positive response for mutagenic effects. 

The Agency further evaluated the 

carcinogenic potential of alkyl 

polyglucoside (C8–20) esters by 

conducting a knowledge base qualitative 

structure activity relationship (SAR) 

database search, DEREK Nexus Version 

2.0, to determine if there were structural 

alerts. No structural alerts were 

identified including carcinogenicity. 

Alkylpolyglycosides are rapidly 

hydrolyzed in intestine and liver. The 

cleavage products, sugars and longchain alcohols, enter the pathways of 

lipid and carbohydrate metabolism. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by, can be found at 

http://www.regulations.gov in the 

document ‘‘PC Codes 911028, 911029, 

911030: Alkyl (C8–20) polyglucoside 

Esters (AGEs); Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations.’’ 

at (6) in docket ID number EPA–HQ– 

OPP–2014–0678. 

B. Toxicological Points of Departure/

Levels of Concern 

Alkylglycosides are rapidly 

hydrolyzed in intestine and liver. The 

cleavage products, sugars, and longchain alcohols enter the pathways of 

lipid and carbohydrate metabolism. 

Based on the low acute toxicity of AGEs, 

the body’s ability to rapidly metabolize 

these substances, the expected 

metabolites being fatty acids and 

carbohydrates (which are normal 

constituents of the body), and the lack 

of observed adverse effects for repeat 

dose studies at the limit dose (1,000 mg/ 

kg/day), no endpoint of concern was 

identified. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to alkyl polyglucoside (C8–20) 

esters, EPA considered exposure under 

the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from alkyl 

polyglucoside (C8–20) esters in food as 

follows: 

Dietary exposure to AGEs can occur 

from eating food treated with alkyl 

polyglucoside (C8–20) esters. However, a 

quantitative assessment was not 

conducted since an endpoint of concern 

for risk assessment was not identified. 

2. Dietary exposure from drinking 

water. Dietary exposure from drinking 

water to alkyl polyglucoside (C8–20) 

esters can occur by drinking water that 

has been contaminated by run-off from 

a pesticide treated area. Since an 

endpoint for risk assessment was not 

identified, a quantitative dietary 

exposure assessment from drinking 

water for alkyl polyglucoside (C8–20) 

esters 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). 

Alkyl polyglucoside (C8–20) esters 

have reported uses in personal care 

products, such as antiperspirants, 

shampoos, conditioners, and 

moisturizers. Residential exposure to 

alkyl polyglucoside (C8–20) esters via the 

oral, dermal, and inhalation route of 

exposure is also possible as a result of 

their use as inert ingredients in 

registered pesticide products that 


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include residential uses. However, since 

there is toxicological endpoint 

identified, it is not necessary to conduct 

assessments of residential (nonoccupational) exposures and risks. 

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 Alkyl 

polyglucoside (C8–20) esters to share a 

common mechanism of toxicity with 

any other substances, and Alkyl 

polyglucoside (C8–20) esters do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that Alkyl 

polyglucoside (C8–20) esters do 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 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) 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 on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infant 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. The database is 

considered adequate for FQPA 

assessment. Fetal susceptibility was not 

observed in the combined repeated dose 

toxicity study with the reproduction/

developmental toxicity screening test in 

the rat. There were no toxic effects 

observed in either study at the highest 

doses tested, 1,000 mg/kg/day. Signs of 

neurotoxicity were not observed in any 

of the submitted studies. No treatment 

related effects in a functional 

observational battery—(FOB) and on 

motor activity parameters were observed 

at doses up to 1,000 mg/kg/day; EPA has 

concluded that a developmental 

neurotoxicity study is not required. 

Signs of potential immunotoxicity were 

not observed in any of the submitted 

studies. Based on its assessment of 

available data for AGEs as discussed in 

Unit IV.A., EPA has concluded that 

there are no toxicological endpoints of 

concern for the U.S. population, 

including infants and children, and has 

conducted a qualitative assessment. 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. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on D-qlucopyranose, 

oligomeric, 6-(dihydrogen citrates), C8–20

branched and linear alkyl glycosides, 

sodium salts; D-glucopyranose, 

oligomeric, 6-(hydrogen 

sulfosuccinates), C8–20 branched and 

linear alkyl glycosides, sodium salts; 

and D-glucopyranose, oligomeric, 

lactates, C8–20 branched and linear alkyl 

glycosides, EPA has determined that 

there is a reasonable certainty that no 

harm to any population subgroup will 

result from aggregate exposure to Dglucopyranose, oligomeric, 6- 

(dihydrogen citrated), C8–20 branched 

and linear alkyl glycosides, sodium 

salts; D-glucopyranose, oligomeric, 6- 

(hydrogen sulfosuccinates), 

C8–20 branched and linear alkyl 

glycosides, sodium salts; and Dglucopyranose, oligomeric, lactates, 

C8–20 branched and linear alkyl 

glycosides under reasonable foreseeable 

circumstances. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180.910 for 

residues of D-glucopyranose, 

oligomeric, 6-(dihydrogen citrates), C8–20

branched and linear alkyl glycosides, 

sodium salts; D-glucopyranose, 

oligomeric, 6-(hydrogen 

sulfosuccinated), C8–20 branched and 

linear alkyl glycosides, sodium salts; 

and D-glucopyranose, oligomeric, 

lactates, C8–20 branched and linear alkyl 

glycosides when used as inert 

ingredients in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest, 

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. Response to Comments 

One comment was received in 

response to the notice of filing. The 

comment received was from a private 

citizen who opposed any pesticide 

product that leaves a residue above 0.00. 

The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that no 

residue of pesticides should be allowed. 

However, under the existing legal 

framework provided by FFDCA section 

408, EPA is authorized to establish 

pesticide tolerances or exemptions 

where persons seeking such tolerances 

or exemptions have demonstrated that 

the pesticide meets the safety standard 

imposed by the statute. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for Dglucopyranose, oligomeric, 6- 

(dihydrogen citrates), C8–20 branched 

and linear alkyl glycosides, sodium salts 

(CAS Reg. No. 1079993–97–7); Dglucopyranose, oligomeric, 6-(hydrogen 

sulfosuccinates), C8–20 branched and 

linear alkyl glycosides, sodium salts 

(CAS Reg. No. 1079993–92–2); and Dglucopyranose, oligomeric, lactates, 

C8–20 branched and linear alkyl 

glycosides (CAS Reg. No. 1079993–94– 

4) esters when used as inert ingredients 

(surfactants) in pesticide formulations 

applied to growing crops and raw 

agricultural commodities after harvest. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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 


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Federal Register / Vol. 80, No. 106 / Wednesday, June 3, 2015 / Rules and Regulations 31485 

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 exemptions 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 action 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 action. In 

addition, this action does not impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act (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 

(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: May 18, 2015. 

Daniel J. Rosenblatt, 

Acting 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. Amend § 180.910 by adding 

alphabetically the following inert 

ingredients to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

D-glucopyranose, oligomeric, 6-(dihydrogen citrates), C8–20 branched and linear alkyl 

glycosides, sodium salts (CAS Reg. No. 1079993–97–7).

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

D-glucopyranose, oligomeric, 6-(hydrogen sulfosuccinates), C8–20 branched and linear alkyl glycosides, sodium salts (CAS Reg. No. 1079993–92–2).............................................. Surfactant. 

D-glucopyranose, oligomeric, lactates, C8–20 branched and linear alkyl glycosides 

(CAS Reg. No. 1079993–94–4).

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

* * * * * * * 

[FR Doc. 2015–13509 Filed 6–2–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 413 

Principles of Reasonable Cost 

Reimbursement; Payment for EndStage Renal Disease Services; 

Optional Prospectively Determined 

Payment Rates for Skilled Nursing 

Facilities 

CFR Correction 

In Title 42 of the Code of Federal 

Regulations, Parts 1 to 399, revised as of 

October 1, 2014, make the following two 

corrections: 

■ 1. On page 817, in § 413.89, reinstate 

paragraph (h)(1)(iii) to read as follows: 

§ 413.89 Bad debts, charity, and courtesy 

allowances. 

* * * * * 

(h) * * * 

(iii) For cost reporting periods 

beginning during fiscal year 2000, by 45 

percent; and 

* * * * * 

■ 2. On page 876, in § 413.337, reinstate 

paragraph (e) to read as follows: 

§ 413.337 Methodology for calculating the 

prospective payment rates. 

* * * * * 

(e) Pursuant to section 101 of the 

Medicare, Medicaid, and SCHIP 

Balanced Budget Refinement Act of 

1999 (BBRA) as revised by section 314 

of the Medicare, Medicaid, and SCHIP 

Benefits Improvement and Protection 

Act of 2000 (BIPA), using the best 

available data, the Secretary will issue 

a new regulation with a newly refined 

case-mix classification system to better 

account for medically complex patients. 

Upon issuance of the new regulation, 

the temporary increases in payment for 

certain high cost patients will no longer 

be applicable. 

[FR Doc. 2015–13434 Filed 6–2–15; 8:45 am] 

BILLING CODE 1505–01–D 


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