Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 45079 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0325; FRL–9930–22] 

Ethanesulfonic Acid, 2-hydroxy and 

the Corresponding Ammonium, 

Sodium, Potassium, Calcium, 

Magnesium, and Zinc 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 ethanesulfonic 

acid, 2-hydroxy- (CAS Reg. No. 107–36– 

8); ethanesulfonic acid, 2-hydroxy-, 

ammonium salt (CAS Reg. No. 57267– 

78–4); ethanesulfonic acid, 2-hydroxy-, 

sodium salt (CAS Reg. No. 1562–00–1); 

ethanesulfonic acid, 2-hydroxy-, 

potassium salt (CAS Reg. No. 1561–99– 

5); ethanesulfonic acid, 2-hydroxy-, 

calcium salt (CAS Reg. No. 10550–47– 

7); ethanesulfonic acid, 2-hydroxy-, 

magnesium salt (CAS Reg. No. 17345– 

56–1), and ethanesulfonic acid, 2- 

hydroxy-, zinc salt (CAS Reg. No. 

129756–32–7) when used as inert 

ingredients (chelator, sequestrant and 

conditioning agent) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest and applied to animals. 

Technology Sciences Group Inc. (1150 

18th St. NW., Suite 1000 Washington, 

DC 20036) on behalf of Huntsman 

Corporation (8600 Gosling Rd., The 

Woodlands, TX 77381) 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 

ethanesulfonic acid, 2-hydroxy- and its 

corresponding ammonium, sodium, 

potassium, calcium, magnesium, and 

zinc salts. 

DATES: This regulation is effective July 

29, 2015. Objections and requests for 

hearings must be received on or before 

September 28, 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–2014–0325, 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 

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. 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–2014–0325 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 September 28, 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– 

2014–0325, 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 August 1, 

2014 (79 FR 44729) (FRL–9911–67), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10684) by Technology 

Sciences Group Inc. (1150 18th St. NW., 

Suite 1000, Washington, DC 20036) on 

behalf of Huntsman Corporation (8600 

Gosling Rd., The Woodlands, TX 

77381). The petition requested that 40 

CFR 180.910 and 40 CFR 180.930 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of ethanesulfonic acid, 2- 

hydroxy- (CAS Reg. No. 107–36–8); 

ethanesulfonic acid, 2-hydroxy-, 

ammonium salt (CAS Reg. No. 57267– 

78–4); ethanesulfonic acid, 2-hydroxy-, 

sodium salt (CAS Reg. No. 1562–00–1); 

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45080 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 

ethanesulfonic acid, 2-hydroxy-, 

potassium salt (CAS Reg. No. 1561–99– 

5); ethanesulfonic acid, 2-hydroxy-, 

calcium salt (CAS Reg. No. 10550–47– 

7); ethanesulfonic acid, 2-hydroxy-, 

magnesium salt (CAS Reg. No. 17345– 

56–1), and ethanesulfonic acid, 2- 

hydroxy-, zinc salt (CAS Reg. No. 

129756–32–7) when used as inert 

ingredients (chelator, sequestrant, and 

conditioning agent) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest and applied to animals in 

accordance with 40 CFR 180.910 and 

180.930, respectively. That document 

referenced a summary of the petition 

prepared by Technology Sciences Group 

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. 

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 . . . .’’ 

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 ethanesulfonic 

acid, 2-hydroxy and the corresponding 

ammonium, sodium, potassium, 

calcium, magnesium, and zinc salts 

(also referred to as isethionic acid and 

its salts) including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with isethionic acid 

and its 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 isethionic acid and its salts as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

Isethionate salts are expected to 

metabolize and dissociate into 

isethionic acid in the body. Therefore, 

toxicity for each of the isethionate salt 

forms are expected to have equal 

toxicity and share similar physical and 

chemical characteristics. Studies on 

isethionic acid or any one of its salt can 

be considered relevant for the entire 

group. 

The acute oral toxicity of isethionic 

acid ammonium salt is low. The acute 

oral lethal dose (LD)50 in rats were 

> 1,000 milligram/kilogram/body weight 

(mg/kg-bw). The acute dermal toxicity 

in rats was > 1,000 mg/kg-bw. 

Ammonium isethionate is a minimal 

eye irritant based on a primary eye 

irritation study in rabbits. Ammonium 

isethionate is not dermally irritating 

based on a primary skin irritation study 

in rabbits. Ammonium isethionate has 

an acute inhalation lethal concentration 

(LC)50 > 6.295 milligram/liter (mg/L) 

and is not a dermal sensitizer. 

In a 90-day oral toxicity study on rats 

via gavage with sodium isethionate, 

decreased mean corpuscular 

hemoglobin concentration, increased 

mean absolute and relative reticulocyte 

counts, increased spleen weights and 

microscopic changes in the liver, bile 

duct, and spleen were observed at 1,000 

milligram/kilogram/day (mg/kg/day) 

(LOAEL). Effects showed complete 

reversal after exposure was 

discontinued. The NOAEL for sodium 

isethionate was identified in this study 

as 200 mg/kg/day. 

In an OSCPP Harmonized Test 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening test, ammonium isethionate 

was administered to rats by gavage. The 

parental systemic LOAEL for 

ammonium isethionate is 500 mg/kg/

day based on absolute and relative 

kidney weights and relative adrenal 

weights, and the parental systemic 

NOAEL is 250 mg/kg/day. The 

reproductive/developmental LOAEL for 

ammonium isethionate in rats was not 

identified, and the reproductive/

developmental NOAEL is greater than or 

equal to 500 mg/kg/day. 

Ammonium isethionate was negative 

for mutagenicity or chromosomal 

aberrations in a battery of tests of 

genotoxicity including a reverse gene 

mutation assay in bacteria, an in vitro 

mammalian cell gene mutation test 

using mouse lymphoma cells and an in 

vitro mammalian cell micronucleus test. 

The OncoLogicTM structure-activity 

model was used to evaluate the 

likelihood that isethionic acid and its 

salts may cause cancer. Structureactivity modeling using Oncologic 

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Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 45081 

indicates that isethionic acid does not 

contain structural alerts of potential 

concern for carcinogenicity. Based on 

the negative results for genotoxicity as 

well as the structure-activity model for 

carcinogenicity there is a low concern 

for isethionic acid and its salts as 

potential carcinogens. 

No neurotoxicity studies were 

available in the database for isethionic 

acid and its salts. However, a functional 

observational battery (FOB) and 

locomotor activity patterns were 

evaluated in the combined 

reproduction/developmental toxicity 

screening test and 90-day oral toxicity 

study. No alterations in the FOB or 

locomotor activity patterns were 

observed. 

No Immunotoxicity studies on 

isethionic acid and its salts were 

available in the database. Increased 

spleen weights and microscopic changes 

in the spleen were observed in the 90- 

day toxicity study in rats; however, the 

chronic reference dose (cRfD) is based 

on this study and is protective of these 

effects. 

No metabolism studies were available 

in the database for isethionic acid and 

its salts. 

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. 

A summary of the toxicological 

endpoints for isethionic acid and its 

salts used for human risk assessment is 

shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISETHIONIC ACID AND ITS SALTS FOR USE IN

HUMAN RISK ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

An acute effect was not found in the database therefore an acute dietary assessment is not necessary. 

Acute dietary (General population including infants and 

children).

An acute effect was not found in the database therefore an acute dietary assessment is not necessary. 

Chronic dietary (All populations) NOAEL = 200 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 200 

mg/kg/day.

cPAD = 2.0 mg/kg/

day.

90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Incidental oral short-term (1 to 

30 days).

NOAEL = 200 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Incidental oral intermediateterm (1 to 6 months).NOAEL = 200 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Dermal short-term (1 to 30 

days).

Dermal (or oral) 

study NOAEL = 

200 mg/kg/day 

(dermal absorption 

rate = 100%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Dermal intermediate-term (1 to 

6 months).

Dermal (or oral) 

study NOAEL = 

200 mg/kg/day 

(dermal absorption 

rate = 100%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

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45082 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ISETHIONIC ACID AND ITS SALTS FOR USE IN

HUMAN RISK ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation short-term (1 to 30 

days).

Inhalation (or oral) 

study NOAEL = 

200 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Inhalation (1 to 6 months) ......... Inhalation (or oral) 

study NOAEL = 

200 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 90-day oral toxicity-rat LOAEL = 1,000 mg/kg/day based on decreased body weight, changes in hematology parameters, increased spleen weights, macroscopic changes in the liver 

and microscopic changes in the liver, bile duct and spleen. 

Cancer (Oral, dermal, inhalation).Based on structural activity analysis, lack of effects suggestive of potential carcinogenicity in subchronic studies and negative results for genotoxicity in bacterial and mammalian cell assays, there is a low concern for the 

salts of isethionate and isethionic acid as potential carcinogens. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to isethionic acid and its salts, 

EPA considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

isethionic acid and its salts in food as 

follows: 

An acute dietary risk assessment was 

not conducted because no endpoint of 

concern following a single exposure was 

identified in the available studies. A 

chronic dietary exposure assessment 

was completed and performed using the 

Dietary Exposure Evaluation Model 

DEEM–FCIDTM, Version 3.16 which 

includes food consumption information 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat In America’’, (NHANES/

WWEIA). This dietary survey was 

conducted from 2003 to 2008. In the 

absence of actual residue data, the inert 

ingredient evaluation is based on a 

highly conservative model that assumes 

that the residue level of the inert 

ingredient would be no higher than the 

highest established tolerance for an 

active ingredient on a given commodity. 

Implicit in this assumption is that there 

would be similar rates of degradation 

between the active and inert ingredient 

(if any) and that the concentration of 

inert ingredient in the scenarios leading 

to these highest of tolerances would be 

no higher than the concentration of the 

active ingredient. The model assumes 

100 percent crop treated (PCT) for all 

crops and that every food eaten by a 

person each day has tolerance-level 

residues. 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 isethionic 

acid and its 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). 

Isethionic acid and its salts may be 

used as inert ingredients in pesticide 

products that are registered for specific 

uses that may result in indoor or 

outdoor residential inhalation and 

dermal exposures. A screening level 

residential exposure and risk 

assessment was completed utilizing 

conservative residential exposure 

assumptions. The Agency assessed 

short- and intermediate-term dermal 

and inhalation exposures for residential 

handlers that would result from low 

pressure hand wand, hose end sprayer 

and trigger sprayer for each pesticide 

type, herbicide, insecticide, and 

fungicide. The Agency assessed postapplication short-term dermal exposure 

for children short-term hand-to-mouth 

and dermal exposure for children and 

adults from contact with treated lawns. 

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 isethionic acid and 

its salts to share a common mechanism 

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Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 45083 

of toxicity with any other substances, 

and isethionic acid and its 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 

isethionic acid and its 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 (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. 

2. Prenatal and postnatal sensitivity. 

Fetal susceptibility was not observed in 

the combined developmental/

reproduction toxicity screening test in 

rats. Neither offspring nor reproduction 

toxicity was observed in this study at 

dose levels up to 500 mg/kg/day in rats, 

the highest dose tested. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for isethionic 

acid and its salts contains the following 

acceptable studies: Subchronic, 

reproduction/developmental screening 

study, and a mutagenicity study. The 

database is considered to be adequate to 

assess prenatal and postnatal toxicity. 

ii. There is no indication that 

isethionic acid and its salts are 

neurotoxic chemicals and there is no 

need for a developmental neurotoxicity 

study or additional uncertainty factors 

(UF) to account for neurotoxicity. 

iii. There is no indication that 

isethionic acid and its salts are 

immunotoxic chemicals. Although 

increased spleen weights and 

microscopic changes in the spleen were 

observed in the 90-day toxicity study in 

rats those effects were due to red blood 

cell destruction and therefore not 

considered an immuno toxic effect. In 

any event, the cRfD is based on this 

study and is protective of these effects. 

Therefore, there is no need for an 

Immunotoxicity study or additional UFs 

to account for Immunotoxicity. 

iv. There is no evidence that 

isethionic acid and its salts result in 

increased susceptibility for infants and 

children. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to isethionic 

acid and its salts in drinking water. EPA 

used similarly conservative assumptions 

to assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by isethionic acid and its 

salts. 

E. Aggregate Risks and Determination of 

Safety 

1. Determination of safety section. 

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. 

2. 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, isethionic acid and 

its salts is not expected to pose an acute 

risk. 

3. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to isethionic acid 

and its salts from food and water will 

utilize 9.5% of the cPAD for the U.S. 

population and 35.3% of the cPAD for 

children 1–2 yrs. old, the population 

group receiving the greatest exposure. 

4. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Isethionic acid and its 

salts may be used as an inert ingredient 

in pesticide products that are registered 

for uses 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 isethionic acid and its 

salts. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 187 for adults and 123 for 

children. Because EPA’s level of 

concern for isethionic acid and its salts 

are MOEs of 100 or below, these MOEs 

are not of concern. 

5. 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). 

Isethionic acid and its salts are currently 

used as an inert ingredient in pesticide 

products that are registered for uses that 

could result in intermediate-term 

residential exposure. The endpoint of 

concern selected for short- and 

intermediate-term exposure assessment 

is the same NOAEL, therefore 

intermediate term exposure is not 

expected to exceed short term aggregate 

exposure and therefore there are no 

concerns for intermediate-term 

aggregate exposure. 

6. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to isethionic 

acid and its salts; therefore, a cancer 

dietary exposure assessment was not 

performed and an aggregate risk and 

aggregate cancer risk assessment is not 

a concern. 

7. 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 isethionic 

acid and its salt residues. 

V. 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. 

VI. Conclusions 

Therefore, exemptions from the 

requirement of a tolerance are 

mstockstill on DSK4VPTVN1PROD with RULES

45084 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 

established under 40 CFR 180.910 and 

40 CFR 180.930 for ethanesulfonic acid, 

2-hydroxy- (CAS Reg. No. 107–36–8); 

ethanesulfonic acid, 2-hydroxy-, 

ammonium salt (CAS Reg. No. 57267– 

78–4); ethanesulfonic acid, 2-hydroxy-, 

sodium salt (CAS Reg. No. 1562–00–1); 

ethanesulfonic acid, 2-hydroxy-, 

potassium salt (CAS Reg. No. 1561–99– 

5); ethanesulfonic acid, 2-hydroxy-, 

calcium salt (CAS Reg. No. 10550–47– 

7); ethanesulfonic acid, 2-hydroxy-, 

magnesium salt (CAS Reg. No. 17345– 

56–1), and ethanesulfonic acid, 2- 

hydroxy-, zinc salt (CAS Reg. No. 

129756–32–7) when used as inert 

ingredients (chelators, sequestrants, and 

conditioning agents) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest and applied to animals. 

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 

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: July 21, 2015. 

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 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 

*******

Ethanesulfonic acid, 2-hydroxy- (CAS Reg. 

No. 107–36–8).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, ammonium 

salts (CAS Reg. No. 57267–78–4).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, calcium salts 

(CAS Reg. No. 10550–47–7).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, magnesium 

salts (CAS Reg. No. 17345–56–1).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, potassium 

salts (CAS Reg. No. 1561–99–5).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, sodium salts 

(CAS Reg. No. 1562–00–1).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, zinc salts 

(CAS Reg. No. 129756–32–7).

........................................................................... Chelator, sequestrant, or conditioning agent. 

*******

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Rules and Regulations 45085 

■ 3. In § 180.930, add alphabetically the 

inert ingredients to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Ethanesulfonic acid, 2-hydroxy- (CAS Reg. 

No. 107–36–8).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, ammonium 

salts (CAS Reg. No. 57267–78–4).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, calcium salts 

(CAS Reg. No. 10550–47–7).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, magnesium 

salts (CAS Reg. No. 17345–56–1).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, potassium 

salts (CAS Reg. No. 1561–99–5).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, sodium salts 

(CAS Reg. No. 1562–00–1).

........................................................................... Chelator, sequestrant, or conditioning agent. 

Ethanesulfonic acid, 2-hydroxy-, zinc salts 

(CAS Reg. No. 129756–32–7).

........................................................................... Chelator, sequestrant, or conditioning agent. 

*******

[FR Doc. 2015–18610 Filed 7–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2005–0002; FRL–9931– 

47–Region 2] 

National Oil and Hazardous Substance 

Pollution Contingency Plan National 

Priorities List: Deletion of the Crown 

Vantage Landfill Superfund Site 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) Region 2 announces the 

deletion of the Crown Vantage Landfill 

Superfund Site (Site), located in 

Alexandria Township, Hunterdon 

County, New Jersey, from the National 

Priorities List (NPL). The NPL, 

promulgated pursuant to section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix of the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). EPA and the 

State of New Jersey, through the New 

Jersey Department of Environmental 

Protection, have determined that all 

appropriate response actions under 

CERCLA, other than long-term 

maintenance and five-year reviews, 

have been completed. However, this 

deletion does not preclude future 

actions under Superfund. 

DATES: This action is effective August 

28, 2015. 

ADDRESSES: Docket: EPA has established 

a docket for this action under Docket 

Identification No. EPA–HQ–SFUND– 

2005–0002. All documents in the docket 

are listed in the http://

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in the 

hard copy. Publicly available docket 

materials are available either 

electronically in http://

www.regulations.gov or in hard copy at 

the Site Information repositories. 

Locations, contacts, telephone numbers 

and viewing hours are: 

U.S. Environmental Protection 

Agency, Region 2, Superfund Records 

Center, 290 Broadway, Room 1828, New 

York, NY 10007–1866, Telephone: 212– 

637–4308, Hours: Monday through 

Friday from 9:00 a.m. to 5:00 p.m. and 

Milford Public Library, Crown 

Vantage Landfill Site Repository File, 40 

Frenchtown Road, Milford, NJ 08848, 

Telephone: 908–995–4072, Hours: 

Monday 12:00 p.m. to 7:00 p.m., 

Tuesday 11 a.m. to 5:00 p.m., 

Wednesday 12 p.m. to 8:00 p.m., 

Thursday 11 a.m. to 8:00 p.m., Friday 

10:00 a.m. to 1:00 p.m. and 5:00 p.m. to 

8:00 p.m., and Saturday 10:00 a.m. to 

1:00 p.m. 

FOR FURTHER INFORMATION CONTACT: 

Alison Hess, Remedial Project Manager, 

U.S. Environmental Protection Agency, 

Region 2, 290 Broadway, 19th Floor, 

New York, NY 10007–1866; Telephone 

212–637–3959; or Email hess.alison@

epa.gov. 

SUPPLEMENTARY INFORMATION: The site to 

be deleted from the NPL is: Crown 

Vantage Landfill Superfund Site, 

Alexandria Township, New Jersey. A 

Notice of Intent to Delete for this Site 

was published in the Federal Register 

(80 FR 23757) on April 29, 2015. The 

closing date for comments on the Notice 

of Intent to Delete was May 29, 2015. No 

comments were received and therefore 

no response to comments was required. 

The deletion action is appropriate. 

EPA maintains the NPL as the list of 

sites that appear to present a significant 

risk to public health, welfare, or the 

environment. Deletion from the NPL 

does not preclude further remedial 

action. Whenever there is a significant 

release from a site deleted from the NPL, 

the deleted site may be restored to the 

NPL without application of the hazards 

ranking system. Deletion of a site from 

the NPL does not affect the responsible 

party liability in the unlikely event that 

future conditions warrant further 

actions. 

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

substances, Hazardous waste, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Dated: July 6, 2015. 

Judith A. Enck, 

Regional Administrator, Region 2. 

For reasons set out in the preamble, 

40 CFR part 300 is amended as follows: 

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