19226 Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 

operating-day average, unless otherwise 

indicated in specific paragraphs. 

Group of coal-fired units 

Federal 

emission 

limitation 

Cholla Power Plant Units 2, 

3, and 4 ............................. 0.055 

Group of coal-fired units 

Federal 

emission 

limitation 

Coronado Generating Station 

Units 1 and 2 .................... 0.065 

* * * * * 

(4) * * * 

(ii) The owners/operators of each unit 

subject to this paragraph (f) shall 

comply with the applicable PM10 and 

SO2 emissions limits submitted to EPA 

as part of the Arizona Regional Haze SIP 

in a letter dated February 28, 2011, and 

approved into the Arizona State 

Implementation Plan on December 5, 

2012, as well as the related compliance, 

recordkeeping and reporting of this 

paragraph (f) no later than the following 

dates: 

Unit 

Compliance date 

PM10 SO2

Cholla Power Plant, Unit 2 ...................................................................... April 1, 2016 .................................. April 1, 2016. 

Cholla Power Plant, Unit 3 ...................................................................... June 3, 2013 .................................. June 3, 2013. 

Cholla Power Plant, Unit 4 ...................................................................... June 3, 2013 .................................. June 3, 2013. 

Coronado Generating Station, Unit 1 ...................................................... June 3, 2013 .................................. June 3, 2013. 

Coronado Generating Station, Unit 2 ...................................................... June 3, 2013 .................................. June 3, 2013. 

* * * * * 

(5) * * * 

(i) * * * 

(A) At all times after the compliance 

date specified in paragraph (f)(4) of this 

section, the owner/operator of each 

coal-fired unit shall maintain, calibrate, 

and operate a CEMS, in full compliance 

with the requirements found at 40 CFR 

part 75, to accurately measure SO2, 

NOX, diluent, and stack gas volumetric 

flow rate from each unit. In addition, 

the owner/operator of Cholla Units 2, 3, 

and 4 shall calibrate, maintain, and 

operate a CEMS, in full compliance with 

the requirements found at 40 CFR part 

75, to accurately measure SO2 emissions 

and diluent at the inlet of the sulfur 

dioxide control device. All valid CEMS 

hourly data shall be used to determine 

compliance with the emission 

limitations for NOX and SO2 in 

paragraph (f)(3) of this section for each 

unit. When the CEMS is out-of-control 

as defined by 40 CFR part 75, that CEMs 

data shall be treated as missing data, 

and not used to calculate the emission 

average. Each required CEMS must 

obtain valid data for at least 90 percent 

of the unit operating hours, on an 

annual basis. 

(B) The owner/operator of each unit 

shall comply with the quality assurance 

procedures for CEMS found in 40 CFR 

part 75. In addition to these 40 CFR part 

75 requirements, relative accuracy test 

audits shall be calculated for both the 

NOX and SO2 pounds per hour 

measurement and the heat input 

measurement. The CEMs monitoring 

data shall not be bias adjusted. The inlet 

SO2 and diluent monitors required by 

this rule shall also meet the Quality 

Assurance/Quality Control (QA/QC) 

requirements of 40 CFR part 75. The 

testing and evaluation of the inlet 

monitors and the calculations of relative 

accuracy for lb/hr of NOX, SO2 and heat 

input shall be performed each time the 

40 CFR part 75 CEMS undergo relative 

accuracy testing. In addition, relative 

accuracy test audits shall be performed 

in the units of lb/MMBtu for the inlet 

and outlet SO2 monitors at Cholla Units 

2, 3, and 4. 

(ii) * * * 

* * * * * 

(B) [Reserved] 

* * * * * 

[FR Doc. 2015–07987 Filed 4–9–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0756; FRL–9923–64] 

Secondary (C13-C17) Alkane Sulfonates; 

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 two secondary 

alkane (C13-C17) sulfonates (CAS Reg. 

Nos. 85711–69–9 and 97489–15–1) 

when used as inert ingredients 

(surfactant) in pesticide formulations 

applied to growing crops at a maximum 

concentration not to exceed 40% by 

weight. Exponent, on behalf of Clariant 

Corporation, submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of secondary alkane (C13- 

C17) sulfonates. 

DATES: This regulation is effective April 

10, 2015. Objections and requests for 

hearings must be received on or before 

June 9, 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–2013–0756, 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 


rljohnson on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19227 

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–2013–0756 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 June 9, 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– 

2013–0756, 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 February 

21, 2014 (79 FR 9870) (FRL–9904–98), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10630) by Exponent, 

1150 Connecticut Ave. NW., 

Washington, DC 20036 on behalf of 

Clariant Corporation, 4000 Monroe Rd., 

Charlotte, NC 28205. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of two inert ingredients, 

collectively referred to as secondary 

alkane (C13-C17) sulfonates (SAS): 

Sulfonic acids, C13-17-sec-alkane, 

sodium salts (CAS Reg. No. 85711–69– 

9) and sulfonic acids, C14-17-sec-alkane, 

sodium salts (CAS Reg. No. 97489–15– 

1) when used as surfactants in pesticide 

formulations applied to growing crops. 

That document referenced a summary of 

the petition prepared by Exponent, 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 is limiting 

the tolerance exemption to pesticide 

formulations in which the maximum 

concentration of the secondary alkane 

sulfonates is 40% by weight. This 

limitation is based on the Agency’s risk 

assessment which can be found at 

http://www.regulations.gov in document 

‘‘Secondary Alkane (C13-C17) Sulfonates 

(SAS); 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 Pre-harvest 

Pesticide Products Under 40 CFR 

180.920’’ in docket ID number EPA– 

HQ–OPP–2013–0756. 

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 


rljohnson on DSK3VPTVN1PROD with RULES
19228 Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 

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 secondary alkane 

(C13-C17) sulfonates including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with secondary alkane (C13- 

C17) sulfonates 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 secondary alkane (C13-C17) sulfonates 

(also referred to as SAS) 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. 

The Agency relied on data on CAS 

Reg. No. 85711–69–9 (sulfonic acids 

(C13-C17 secondary alkane) to assess both 

inert ingredients. Bridging data in this 

manner is appropriate because CAS Reg. 

No. 97489–15–1 (sulfonic acids, C14-C17

secondary alkane) has an alkyl carbon 

chain length that falls within the carbon 

chain length range of CAS Reg. No. 

85711–69–9 (sulfonic acids, C13-C17

secondary alkane) and toxic effects 

attributable to the C14-C17 secondary 

alkane sulfonate would be observed in 

toxicity testing of the C13-C17 secondary 

alkane sulfonate. 

The acute oral lethal dose (LD50) for 

SAS in rats is >500 milligram/kilogram 

(mg/kg). The acute dermal LD50 in mice 

is >200 mg/kg. Secondary alkane (C13- 

C17) sulfonate is not a dermal irritant 

based on primary skin irritation study in 

rabbits and it is not a dermal sensitizer 

in guinea pigs. 

A chronic toxicity study was 

conducted on SAS in rats and 

demonstrated a NOAEL of 4,000 parts 

per million (ppm) (equivalent to 168 

milligram/kilogram body weight/day 

(mg/kg bw/day) in males and 227 mg/ 

kg bw/day in females), and a LOAEL of 

20,000 ppm (equivalent to 920 mg/kg 

bw/day in males and 1,281 mg/kg bw/ 

day in females) based on reduced body 

weight, body weight gain, and the 

clinical signs of reduced grooming in 

males and females. 

In a 2-generation reproduction study 

in rats dosed with SAS, there was no 

indication that offspring were more 

susceptible than the parental adults. 

The parental systemic LOAEL was 3,000 

ppm (equivalent to 177 mg/kg bw/day 

in males and 181 mg/kg bw/day in 

females), based on decreased body 

weight gain during premating and on 

reduced organ weight. The parental 

NOAEL was 1,000 ppm (equivalent to 

58.2 mg/kg bw/day for males and 66 

mg/kg bw/day for females). The 

offspring LOAEL was 3,000 ppm 

(equivalent to 177 mg/kg bw/day) based 

on decreased pre- and post-implantation 

loss and decreased weight gain in 

offspring. The offspring NOAEL was 

1,000 ppm (equivalent to 58.2 mg/kg 

bw/day). 

Secondary alkane (C13-C17) sulfonates 

were not mutagenic when tested in the 

in vitro mammalian cell gene mutation 

assay and in the Salmonella 

typhimurium reverse mutation assay. 

In a combined oral (dietary) chronic 

toxicity/carcinogenicity study of SAS in 

rats, there were no treatment-related 

neoplastic or non-neoplastic 

microscopic findings observed up to 

2.0% (equivalent to 805 mg/kg bw/day 

in males and 1,032 mg/kg bw/day in 

females), the highest dose tested. A 

LOAEL was not identified. Although 

body weight of high-dose males and 

females were lower by about 20% 

relative to controls throughout most of 

the study, decreased body weight was 

not viewed as an adverse effect since 

higher survival rates were observed in 

this group compared to controls. 

In a dermal carcinogenicity study of 

SAS in mice, no indication of increased 

incidence relative to controls of 

malignant neoplasms was observed. No 

LOAEL was demonstrated. The NOAEL 

was 1.0% (equivalent to 0.6 mg/ 

treatment), the highest concentration 

applied to the skin. 

Secondary alkane (C13-C17) sulfonates 

are rapidly absorbed and excreted in the 

urine and feces. Secondary alkane (C13- 

C17) sulfonates have a low potential for 

dermal absorption based on a dermal 

penetration study in rats. 

Although no immunotoxicity or 

neurotoxicity studies on SAS were 

available in the database, no evidence of 

immunotoxicity or neurotoxicity was 

observed in the submitted studies. 

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 (UF) 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 nonthreshold 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 secondary alkane (C13-C17) 

sulfonates used for human risk 

assessment is shown in Table 1 of this 

unit. 

The 2-generation reproductive 

toxicity study in rats was selected for 

oral, dietary, dermal, and inhalation 

exposure scenarios (all durations) for 

this risk assessment. The parental 

systemic NOAEL in this study was 

1,000 ppm (equivalent to 58.2 mg/kg 

bw/day for males) based on reduced 

body weight gain during premating and 

on reduced organ weight seen at the 

LOAEL of 3,000 ppm (equivalent to 177 

mg/kg bw/day). The rationale for 

selecting this study for the dietary, 

dermal, and inhalation exposure 

scenario is based on the fact that this 

study provided the lowest and most 

conservative toxicity endpoint and 

route-specific studies are available. 

A default 100% inhalation absorption 

will be used for inhalation exposure 

scenarios. A 50% dermal absorption rate 

will be used for dermal exposure 

scenarios based on the toxicokinetic 

dermal absorption study. 


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Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19229 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SECONDARY ALKANE (C13-C17) SULFONATES 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 

Chronic dietary (All populations) NOAEL = 58.2 mg/ 

kg bw/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.582 

mg/kg bw/day.

cPAD = 0.58 mg/kg 

bw/day.

Rat reproductive toxicity study. 

LOAEL = 177 mg/kg bw/day based on decreased weight gain 

during premating and reduced organ weight. 

Cancer (Oral, dermal, inhalation).Based on the lack of 

increased incidence of tumor 

formation compared to controls 

in multiple carcinogenicity studies 

and the lack of 

mutagenicity, SAS 

is considered not 

likely to be carcinogenic.

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 secondary alkane (C13-C17) 

sulfonates, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

secondary alkane (C13-C17) sulfonates in 

food as follows: 

i. Acute Exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide 

chemical, if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a 1-day 

or single exposure. No such effects were 

identified in the toxicological studies 

for SAS; therefore, a quantitative acute 

dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. The chronic 

dietary exposure assessment for this 

inert ingredient utilizes the Dietary 

Exposure Evaluation Model Food 

Commodity Intake Database (DEEM– 

FCID), Version 3.16, EPA, 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 which 

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. 

iii Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that SAS does not pose a 

cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

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 secondary 

alkane (C13-C17) sulfonates, 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). 

Based on the use pattern for pesticide 

products containing SAS as an inert 

ingredient, there are no residential uses 

and thus no residential exposures are 

expected. 

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 secondary alkane 

(C13-C17) sulfonates to share a common 

mechanism of toxicity with any other 

substances, and secondary alkane (C13- 

C17) sulfonates do not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that secondary alkane (C13-C17) 

sulfonates do not have a common 

mechanism of toxicity with other 


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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. 

In a 2-generation reproduction toxicity 

study, there was no evidence of 

susceptibility of infants and children to 

SAS. In this study, the offspring and 

parental toxicity NOAEL was 1,000 ppm 

(equivalent to 58.2 mg/kg bw/day) based 

decreased pre- and post-implantation 

loss and decreased weight gain in 

offspring and decreased body weight 

gain during premating and on reduced 

organ weight in parental animals seen at 

the LOAEL was 3,000 ppm (equivalent 

to 177 mg/kg bw/day). 

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 secondary 

alkane (C13-C17) sulfonates includes a 

subchronic toxicity study, a 2- 

generation reproduction study, chronic/ 

carcinogenicity studies, several 

mutagenicity studies, and two 

toxicokinetic studies. The Agency 

concludes that for this ingredient, the 

results of these studies provide a 

reliable basis for assessing the range of 

potential effects to infants and children, 

such that the Agency has determined 

that no additional data are necessary at 

this time to evaluate effects to infants 

and children. 

ii. There is no indication that SAS is 

a neurotoxic chemical and there is no 

need for a developmental neurotoxicity 

study or additional UFs to account for 

neurotoxicity. 

iii. There is no evidence of increased 

susceptibility due to pre-or post-natal 

exposure to SAS in infants and 

children. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 percent 

crop treated (PCT) and tolerance-level 

residues. EPA made conservative 

(protective) assumptions utilizing a 100 

ppb default value in the ground and 

surface water modeling used to assess 

exposure to secondary alkane (C13-C17) 

sulfonates in drinking water. These 

assessments will not underestimate the 

exposure and risks posed by secondary 

alkane (C13-C17) sulfonates. 

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, 

therefore, an acute dietary exposure 

assessment was not conducted. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to SAS from food 

and water will utilize 97.1% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). A short-term/

intermediate-term adverse effect was 

identified; however, SAS is not used as 

inert ingredient in any pesticide product 

registered for any use patterns that 

would result in short-term or 

intermediate-term residential exposure. 

Because there is no short-term or 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess short-term risk), no further 

assessment of short-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short-term risk for SAS. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

rodent carcinogenicity studies, 

secondary alkane (C13-C17) sulfonates 

are not expected to pose a cancer risk 

to humans. 

5. 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 secondary 

alkane (C13-C17) sulfonates residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Although EPA is establishing a 

limitation on the amount of SAS that 

may be used in pesticide formulations, 

an analytical enforcement methodology 

is not necessary for this exemption. The 

limitation 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 for sale or distribution for use 

on growing crops with concentrations of 

SAS exceeding 40% by weight of the 

formulation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nation Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for secondary alkane (C13-C17) 

sulfonates. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 


rljohnson on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19231 

under 40 CFR 180.920 for sulfonic 

acids, C13-17-sec-alkane, sodium salts 

(CAS Reg. No. 85711–69–9) and sulfonic 

acids, C14-17-sec-alkane, sodium salts 

(CAS Reg. No. 97489–15–1) when used 

as inert ingredients (surfactant) in 

pesticide formulations applied to 

growing crops at not more than 40% by 

weight of the pesticide formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this 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 exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This 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: March 10, 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 § 180.920, add alphabetically the 

following inert ingredients to the table 

to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Sulfonic acids, C13-17-sec-alkane, sodium salts (CAS Reg. No. 

85711–69–9).

Not to exceed 40% by weight in non-residential use pesticide 

formulation only.

Surfactant. 

Sulfonic acids, C14-17-sec-alkane, sodium salts (CAS Reg. No. 

97489–15–1).

Not to exceed 40% by weight in non-residential pesticide formulation only.Surfactant. 

* * * * * * * 

[FR Doc. 2015–08218 Filed 4–9–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0798; FRL–9925–02] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on the herb subgroup 19A, dill 

seed, the stone fruit group 12–12, and 

the tree nut group 14–12, except 

pistachio. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

10, 2015. Objections and requests for 

hearings must be received on or before 


rljohnson on DSK3VPTVN1PROD with RULES