Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27025 

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). 

VII. 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: April 26, 2016. 

Susan Lewis, 

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 § 180.666, amend the table in 

paragraph (a) as follows: 

■ i. Add alphabetically the entries 

‘‘Citrus, dried pulp’’, ‘‘Citrus, oil’’, 

‘‘Fruit, citrus, group 10–10’’, ‘‘Grass 

forage, fodder and hay, group 17’’, 

‘‘Milk, fat’’, ‘‘Non-grass animal feed, 

group 18’’, ‘‘Poultry, fat’’, ‘‘Poultry, 

meat’’ and ‘‘Poultry, meat byproduct’’. 

■ ii. Revise the following entries 

‘‘Cattle, fat’’, ‘‘Cattle, meat byproduct’’, 

‘‘Egg’’, ‘‘Goat, fat’’, ‘‘Goat, meat 

byproduct’’, ‘‘Horse, fat’’, ‘‘Horse, meat 

byproduct’’, ‘‘Milk’’, ‘‘Sheep, fat,’’ and 

‘‘Sheep, meat byproduct’’. 

■ iii. Remove from the table in 

paragraph (d) the entry ‘‘non-grass 

animal feeds, group 18’’. 

The amendments read as follows: 

§ 180.666 Fluxapyroxad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, fat .............................. 0.06 

* * * * * 

Cattle, meat byproduct ......... 0.04 

Citrus, dried pulp .................. 3.0 

Citrus, oil ............................... 40 

* * * * * 

Egg ....................................... 0.01 

Fruit, citrus, group 10–10 ..... 1.0 

* * * * * 

Grass, forage, fodder and 

hay, group 17 .................... 40 

Goat, fat ................................ 0.06 

* * * * * 

Goat, meat byproduct ........... 0.04 

* * * * * 

Horse, fat .............................. 0.06 

* * * * * 

Horse, meat byproduct ......... 0.04 

Milk ....................................... 0.01 

Milk, fat ................................. 0.15 

Non-grass animal feed, 

group 18 ............................ 30 

* * * * * 

Poultry, fat ............................ 0.01 

Poultry, meat ........................ 0.01 

Poultry, meat byproduct ....... 0.01 

* * * * * 

Sheep, fat ............................. 0.06 

* * * * * 

Sheep, meat byproduct ........ 0.04 

* * * * * 

* * * * * 

[FR Doc. 2016–10581 Filed 5–4–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0213; FRL–9945–58] 

Butanedioic Acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, Disodium 

Salts; 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 butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts (CAS Reg. No. 

815583–91–6) when used as an inert 

ingredient (surfactant) in pesticides 

applied to growing crops and raw 

agricultural commodities after harvest 

under 40 CFR 180.910 limited to 

maximum concentration of 10% by 

weight in pesticide formulations. Keller 

and Heckman LLP on behalf of Cytec 

Industries, 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 butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts. 

DATES: This regulation is effective May 

5, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 2016, 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–2015–0213, 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), 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 


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27026 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 

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–2015–0213 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 July 5, 2016. 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– 

2015–0213, 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 May 20, 

2015 (80 FR 28925) (FRL–9927–39), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10760) by Keller and 

Heckman LLP, (1001 G Street NW., 

Suite 500, Washington, DC 20001) on 

behalf of Cytec Industries, Inc. (5 Garret 

Mountain Plaza, Woodland Park, NJ 

07424). The petition requested that 40 

CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

(CAS Reg. No. 815583–91–6) when used 

as an inert ingredient (surfactant) in 

pesticide formulations applied to 

growing crops and raw agricultural 

commodities after harvest. That 

document referenced a summary of the 

petition prepared by Keller and 

Heckman LLP, on behalf of Cytec 

Industries, Inc., the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has limited 

the maximum concentration of 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

to 10% by weight in pesticide 

formulations. This limitation is based 

on the Agency’s risk assessment which 

can be found at http://

www.regulations.gov in document 

‘‘Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

(CAS Reg No. 815583–91–6); Human 

Health Risk Assessment and Ecological 

Effects Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations’’ in 

docket ID number EPA–HQ–OPP–2015– 

0213. 

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 exemption is ‘‘safe.’’ 

Section 408(c)(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 or exemption 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 ingredient 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 


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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27027 

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 butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with butanedioic acid, 2- 

sulfo-, C-C9-11-isoalkyl esters, C10-rich, 

disodium salts 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 butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies are discussed 

in this unit. 

Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

is of low acute oral and dermal toxicity 

in rats. The acute oral and dermal LD50s 

are >1,600 milligram/kilogram (mg/kg). 

It is irritating to the eyes but not the 

skin of rabbits. Neither inhalation nor 

sensitization studies are available. 

90-day oral toxicity studies are 

available in rats and dogs. In the rat, 

toxicity is manifested as decreased body 

weight and food efficiency at 4% 

(equivalent to 3,080 milligram/

kilogram/day (mg/kg/day)) of 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts. 

In dogs, toxicity is manifested as 

testicular atrophy at 0.5% (equivalent to 

125 mg/kg/day). The NOAEL in this 

study is 0.12% (equivalent to 30 mg/kg/ 

day). The chronic reference dose (cRfD) 

is based on this study. 

A combined reproductive and 

developmental study on rats is available 

with butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts. 

Quantitative fetal susceptibility is 

observed as reduced pup weight at 1% 

(equivalent to 750 mg/kg/day). Maternal 

toxicity is reported only with regard to 

reproduction toxicity and included a 

reduced number of viable embryos and 

live-born per litter, and reduced 

fertility, viability and lactation indices 

at 4% (equivalent to 3,000 mg/kg/day). 

Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

is not expected to be carcinogenic based 

on the absence of structural alerts using 

the Derek Nexus program and the lack 

of mutagenicity in two Ames tests. 

Neurotoxicity and immunotoxicity 

studies with butanedioic acid, 2-sulfo-, 

C-C9-11-isoalkyl esters, C10-rich, 

disodium salts are not available for 

review. However, no evidence of 

potential neurotoxicity or 

immunotoxicity is observed in the 

submitted studies. 

Metabolism studies with butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts are not 

available for review. However, it is 

expected that these salts will readily 

hydrolyze (primarily in the intestine, 

blood and liver) by carboxylesterases 

resulting in the corresponding alcohol 

(C9-C l1 isoalkyl, Cl0 rich). The fatty 

alcohol is expected to be metabolized 

via normal metabolic pathways 

(oxidation, followed by normal fatty 

acid metabolism). 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

An acute effect was not found in the 

database therefore an acute dietary 

assessment was not conducted. The 

cRfD as well as all exposure scenarios 

was based on the 90-day oral toxicity 

study in the dog. In this study, the 

LOAEL was 0.5% (equivalent to 125 

mg/kg/day) based on testicular atrophy 

in males. The NOAEL was 0.12% 

(equivalent to 30 mg/kg/day). This 

represents the lowest NOAEL in the 

most sensitive species in the toxicity 

database. The standard uncertainty 

factors were applied to account for 

interspecies (10x) and intraspecies (10x) 

variations. Default values of 100% 

absorption were used for the dermal and 

inhalation factors. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to butanedioic acid, 2-sulfo-, 

C-C9-11-isoalkyl esters, C10-rich, 

disodium salts, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

in food as follows: 

Dietary exposure (food and drinking 

water) to butanedioic acid, 2-sulfo-, 

C-C9-11-isoalkyl esters, C10-rich, 

disodium salts can occur following 

ingestion of foods with residues from 

treated crops. Because no adverse effects 

attributable to a single exposure of 

butanedioic acid, 2-sulfo-, 

C-C9-11-isoalkyl esters, C10-rich, 

disodium salts are seen in the toxicity 

databases, an acute dietary risk 

assessment was not conducted. For the 

chronic dietary risk assessment, EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCIDTM, Version 3.16, and food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, no residue data 

were submitted for butanedioic acid, 2- 

sulfo-, C-C9-11-isoalkyl esters, C10-rich, 

disodium salts. In the absence of 

specific residue data, EPA has 

developed an approach which uses 

surrogate information to derive upper 

bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high use insecticides, 

herbicides, and fungicides. 100 percent 

crop treated (PCT), default processing 


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factors, and tolerance-level residues 

were assumed for all foods, and the 

assessment incorporated the use 

limitation that the ingredient will be 

present in pesticide formulations at a 

concentration of not more than 10% by 

weight. A complete description of the 

general approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts,’’ (D361707, 

S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts, 

a conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

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). 

Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

may be used in inert ingredients in 

products that are registered for specific 

uses that may result in residential 

exposure, such as pesticides used in and 

around the home. Based on the available 

data for products registered for 

residential use, the Agency concluded 

that products containing inert chemicals 

similar to butanedioic acid, 2-sulfo-, 

C-C9-11-isoalkyl esters, C10-rich, 

disodium salts (ie surfactant) usually 

comprise no more than 2–5% of the 

inert ingredient in the final product. 

Therefore, the Agency conducted an 

assessment to represent conservative 

residential exposure by assessing 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

in pesticide formulations (outdoor 

scenarios) and in disinfectant-type uses 

(indoor scenarios) at no more than 5% 

in the final formulation. 

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 butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts to share a common 

mechanism of toxicity with any other 

substances, and butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts 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 

1. In general. 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 infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA 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. 

2. Prenatal and postnatal sensitivity. 

The toxicity database for butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts contains 

subchronic, combined reproduction/

teratology and mutagenicity studies. 

There is no indication of potential 

neurotoxicity or immunotoxicity in the 

available studies. Quantitative increased 

fetal susceptibility was observed in the 

combined reproduction/teratology study 

in rats. Fetal toxicity (reduced pup 

weight) was observed at the lowest dose 

tested, 750 mg/kg/day. Maternal/

reproduction toxicity was observed at 

3,000 mg/kg/day and manifested as a 

reduction in the number of viable 

embryos, live-born per litter, fertility, 

viability, and lactation indices. The 

addition of a 10x FQPA safety factor to 

account for quantitative susceptibility 

and LOAEL to NOAEL extrapolation is 

not necessary because it would result in 

a cRfD of 0.75 mg/kg/day and the 

established cRfD is 0.30 mg/kg/day. The 

cRfD is considerably lower and will be 

protective of fetal susceptibility and 

effects observed at 750 mg/kg/day. 

Therefore, retention of the FQPA safety 

factor is unnecessary. There is low 

concern for reproduction toxicity since 

the aforementioned effects occurred 

above the limit dose of 1,000 mg/kg/day 

and a clear NOAEL of 750 mg/kg/day 

was established. Therefore, the 

established cRfD will be protective of 

these effects. In addition, the Agency 

used the most conservative (highest) 

exposure estimates and assumptions, 

including 100 PCT and tolerance-level 

residues for all foods, conservative 

estimates of drinking water exposure, 

and a conservative assessment of 

potential residential exposure for 

infants and children. Therefore, the 

FQPA SF of 10x is reduced to 1x. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, butanedioic acid, 2- 

sulfo-, C-C9-11-isoalkyl esters, C10-rich, 

disodium salts is not expected to pose 

an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts from food and 

water will utilize 47.9% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 


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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 27029 

(considered to be a background 

exposure level). 

Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

may be used as inert ingredients in 

pesticide products that could result in 

short-term residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts. 

Using the exposure assumptions 

described above, EPA has concluded 

that the combined short-term aggregated 

food, water, and residential exposures 

result in MOEs of 126 for both adult 

males and females. Adult residential 

exposure combines high end dermal and 

inhalation handler exposure from 

liquids/trigger sprayer/home garden use 

with a high end post application dermal 

exposure from contact with treated 

lawns. Also, EPA has concluded the 

combined short-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 135 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated lawns (dermal and hand-tomouth exposures). As the level of 

concern is for MOEs that are lower than 

100, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

may be used as inert ingredients in 

pesticide products that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts. 

Using the exposure assumptions 

described above, EPA has concluded 

that the combined intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs of 480 for 

adult males and females. Adult 

residential exposure combines liquids/

trigger sprayer/home garden use with a 

high end post application dermal 

exposure from contact with treated 

lawns. As the level of concern is for 

MOEs that are lower than 100, this MOE 

is not of concern. EPA has concluded 

the combined intermediate-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

158 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

surfaces (dermal and hand-to-mouth 

exposures). As the level of concern is for 

MOEs that are lower than 100, this MOE 

is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis and the lack of 

mutagenicity, butanedioic acid, 

2-sulfo-, C-C9-11-isoalkyl esters, C10- 

rich, disodium salts is not expected to 

pose a cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts residues. 

V. Other Considerations 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of butanedioic 

acid, 2-sulfo-, C-C9-11-isoalkyl esters, 

C10-rich, disodium salts in or on any 

food commodities. EPA is establishing 

limitations on the amount of 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

that may be used in pesticide 

formulations applied to growing crops. 

These limitations will be enforced 

through the pesticide registration 

process under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(‘‘FIFRA’’), 7 U.S.C. 136 et seq. EPA will 

not register any pesticide formulation 

for use on growing crops or raw 

agricultural commodities after harvest 

for sale or distribution that exceeds 10% 

by weight of butanedioic acid, 2-sulfo- 

, C-C9-11-isoalkyl esters, C10-rich, 

disodium salts unless additional data 

are submitted. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180. 910 for of 

butanedioic acid, 2-sulfo-, C-C9-11- 

isoalkyl esters, C10-rich, disodium salts 

(CAS Reg. No. 815583–91–6) when used 

as inert ingredients (surfactant) at a 

maximum concentration of 10% by 

weight in pesticide formulations 

applied to growing crops or to raw 

agricultural commodities after harvest. 

VII. Statutory and Executive Order 

Reviews 

This action establishes 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 

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 tolerance 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 


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27030 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Rules and Regulations 

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: April 26, 2016. 

Susan Lewis, 

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, add alphabetically the 

inert ingredient ‘‘Butanedioic acid, 2- 

sulfo-, C-C9-11-isoalkyl esters, C10-rich, 

disodium salts (CAS Reg. No. 815583– 

91–6)’’ 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 

*******

Butanedioic acid, 2-sulfo-, C-C9-11-isoalkyl esters, C10-rich, disodium salts (CAS Reg. No. 815583–91–6).Not to exceed 10% by weight in pesticide formulation for agricultural use.Surfactant. 

* * * * * * * 

[FR Doc. 2016–10582 Filed 5–4–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 36 

[Docket No. FWS–R7–NWRS–2014–0003; 

FF07RKNA00 FXRS12610700000 167] 

RIN 1018–AX56 

Refuge-Specific Regulations; Public 

Use; Kenai National Wildlife Refuge 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), are amending 

the regulations for Kenai National 

Wildlife Refuge (Kenai NWR or Refuge) 

that govern existing general public use 

and recreation. These changes will 

implement management direction and 

decisions from our June 2010 Kenai 

NWR revised comprehensive 

conservation plan and June 2007 Skilak 

Wildlife Recreation Area final revised 

management plan. The amendments to 

the regulations are designed to enhance 

natural resource protection, public use 

activities, and public safety on the 

Refuge; are necessary to ensure the 

compatibility of public use activities 

with the Refuge’s purposes and the 

Refuge System’s purposes; and ensure 

consistency with management policies 

and approved Refuge management 

plans. 

DATES: This rule is effective June 6, 

2016. 

FOR FURTHER INFORMATION CONTACT: 

Andy Loranger, Refuge Manager, Kenai 

NWR, P.O. Box 2139, Ski Hill Rd., 

Soldotna, AK 99669; telephone: 907– 

262–7021; facsimile 907–262–3599. If 

you use a telecommunications device 

for the deaf (TDD), call the Federal 

Information Relay Service (FIRS) at 

800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Background 

President Franklin D. Roosevelt 

established the Kenai National Moose 

Range (Moose Range) on December 16, 

1941, for the purpose of ‘‘protecting the 

natural breeding and feeding range of 

the giant Kenai moose on the Kenai 

Peninsula, Alaska, which in this area 

presents a unique wildlife feature and 

an unusual opportunity for the study in 

its natural environment of the practical 

management of a big game species that 

has considerable local economic value’’ 

(Executive Order 8979; see 6 FR 6471, 

December 18, 1941). 

Section 303(4) of the Alaska National 

Interest Lands Conservation Act of 1980 

(ANILCA) (16 U.S.C. 3101 et seq.) 

substantially affected the Moose Range 

by modifying its boundaries and 

broadening its purposes from moose 

conservation to protection and 

conservation of a broad array of fish, 

wildlife, habitats, and other resources, 

and to providing educational and 

recreational opportunities. ANILCA also 

redesignated the Moose Range as the 

Kenai National Wildlife Refuge (NWR or 

Refuge) and increased the size of the 

Refuge to 1.92 million acres, of which 

approximately two-thirds were 

designated as Wilderness and made part 

of the National Wilderness Preservation 

System. 

ANILCA sets out additional purposes 

for each refuge in Alaska; the purposes 

of Kenai NWR are set forth in section 

303(4)(B) of ANILCA. The purposes 

identify some of the reasons why 

Congress established the Refuge and set 

the management priorities for the 

Refuge. The purposes are as follows: 

(1) To conserve fish and wildlife 

populations and habitats in their natural 

diversity including, but not limited to, 

moose, bears, mountain goats, Dall 

sheep, wolves and other furbearers, 

salmonoids and other fish, waterfowl 

and other migratory and nonmigratory 

birds; 

(2) To fulfill the international treaty 

obligations of the United States with 

respect to fish and wildlife and their 

habitats; 

(3) To ensure, to the maximum extent 

practicable and in a manner consistent 

with the purposes set forth in (1), above, 

water quality and necessary water 

quantity within the Refuge; 

(4) To provide, in a manner consistent 

with (1) and (2), above, opportunities for 

scientific research, interpretation, 

environmental education, and land 

management training; and 

(5) To provide, in a manner 

compatible with these purposes, 

opportunities for fish and wildlifeoriented recreation. 

The Wilderness Act of 1964 (16 U.S.C. 

1131–1136) provides the following 

purposes for wilderness areas, including 

the Kenai wilderness area: 


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