Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 11589 

* * * * * 

[FR Doc. 2015–04277 Filed 3–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0601; FRL–9922–29] 

9-Octadecenoic Acid (9Z)-, Sulfonated, 

Oxidized and its Potassium and 

Sodium 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 9-octadecenoic 

acid (9Z)-, sulfonated, oxidized; 9- 

octadecenoic acid (9Z)-, sulfonated, 

oxidized, potassium salts; and 9- 

octadecenoic acid (9Z)-, sulfonated, 

oxidized, sodium salts, when used as an 

inert ingredient in antimicrobial 

pesticide formulations used on food 

contact surfaces in public eating places, 

dairy processing equipment and food 

processing equipment and utensils at a 

maximum end-use concentration not to 

exceed 250 parts per million (ppm). 

Ecolab 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 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized and its 

potassium and sodium salts. 

DATES: This regulation is effective 

March 4, 2015. Objections and requests 

for hearings must be received on or 

before May 4, 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–2013–0601, 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, Director, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http://

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

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2013–0601 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 May 4, 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– 

2013–0601, 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 September 

12, 2013 (78 FR 56185) (FRL–9399–7), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10549) by Ecolab, Inc. 

370 N. Wabasha Street, St. Paul, MN 

55102. The petition requested that 40 

CFR 180.940(a) be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of 9-octadecenoic acid (9Z)-, sulfonated, 

oxidized (CAS Reg. No. 1315321–93–7); 

9-octadecenoic acid (9Z)-, sulfonated, 

oxidized, potassium salts (CAS Reg. No. 

1315321–94–8); and 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized, sodium 

salts, (CAS No. 1315321–95–9) when 

used as an inert ingredient in 

antimicrobial pesticide formulations 

used on food contact surfaces in public 

eating places, dairy processing 

equipment, and food processing 

equipment and utensils at a maximum 

end-use concentration not to exceed 250 

ppm. That document referenced a 

summary of the petition prepared by 

Ecolab Inc, the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 


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11590 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 

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 9-octadecenoic 

acid (9Z)-, sulfonated, oxidized and its 

potassium and sodium salts including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized and its 

potassium and sodium 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 9-octadecenoic acid (9Z)-, sulfonated, 

oxidized and its potassium and sodium 

salt (also referred to as peroxy 

sulfonated oleic acid (PSOA)) as well as 

the no-observed-adverse-effect-level 

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

toxicity studies discussed in this unit. 

Peroxy sulfonated oleic acid is acutely 

toxic via the oral route and is highly 

corrosive via the dermal and inhalation 

routes of exposure. In a 28-day oral 

toxicity study (OECD Guideline 407), 

rats were administered PSOA via gavage 

at dose levels of 15 milligrams/

kilogram/day (mg/kg/day) and 50 mg/

kg/day. No observable adverse effects 

were seen at either dose level but since 

no systemic effects were observed, the 

dosing was considered by the Agency to 

not be adequate. 

In a developmental toxicity (OECD 

Guideline 414) study with PSOA, the 

parental NOAEL for systemic effects 

was 50 mg/kg bw/day, the highest dose 

tested. The NOAEL for embryotoxic, 

fetotoxic and developmental effects was 

also 50 mg/kg bw/day, the highest dose 

tested. 

The dosing in the 28-day gavage study 

and the developmental toxicity studies 

was considered inadequate because 

animals were not challenged at higher 

doses. The applicant suggested that the 

higher doses were not utilized because 

of the corrosive nature of the chemical. 

Since there was no evidence of 

corrosivity in the study, a 14-day oral 

toxicity study was conducted at dose 

levels of 100 mg/kg/day, 300 mg/kg/day 

and 1,000 mg/kg/day. The study results 

confirmed that higher doses would have 

been corrosive. 

In a series of genotoxicity studies 

PSOA is negative for inducing 

mutations in bacterial and mammalian 

cells, with and without metabolic 

activation. In the in vitro chromosome 

aberration study using human 

lymphocytes, PSOA was positive with 

and without metabolic activation. 

However, the in vivo micronucleus 

assay in rats was negative. 

A neurotoxicity study was not 

conducted with PSOA. However, 

detailed functional observations were 

made among the parameters measured 

in the 28-day subchronic oral feeding 

study. There were no PSOA related 

changes in any of the parameters 

measured, including functional 

observations battery (FOB). No evidence 

of neurotoxicity was observed. An 

immunotoxicity study was not 

conducted with PSOA. However, 

minimal hemorrhage in the thymus was 

observed after the recovery period in the 

14-day oral toxicity study with rats. 

Since, this effect is a common 

background lesion it is not considered 

indicative of potential immunotoxicity. 

There are no known chronic toxicity 

studies with PSOA and no available 

PSOA mammalian metabolism 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 no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 


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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. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR 9-OCTADECENOIC ACID (9Z)-, SULFONATED, 

OXIDIZED AND ITS POTASSIUM AND SODIUM SALT FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario 

Dose used in risk assessment, 

interspecies and intraspecies and 

any traditional UF 

Special FQPA SF and LOC for 

risk assessment Study and toxicological effects 

Acute dietary (all populations) ....... An endpoint attributable to a single dose exposure has not been identified. 

Chronic dietary (all populations) .... NOAEL= 50 mg/kg/day .................

UFA = 10X 

UFH= 10X 

Chronic RfD = 0.5 mg/kg/day 

FQPA SF = 1X .............................

cPAD = chronic RfD/Special 

14-day and 28-day rat oral toxicity 

study in rats. 

LOAEL = 300 mg/kg/day based 

on gastrointestinal irritation. 

Cancer (Oral, dermal, inhalation) .. NA ................................................. NA ................................................. NA. 

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 PSOA, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

peroxy sulfonated oleic acids in food as 

follows: 

In the absence of actual dietary 

exposure data resulting from this use, 

EPA has utilized a conservative, healthprotective method of estimating dietary 

intake that is based upon conservative 

assumptions related to the amount of 

residues that can be transferred to foods 

as a result of the proposed use of 9- 

octadecenoic acid (9Z)-, sulfonated, 

oxidized and its potassium and sodium 

salts in food contact sanitizing pesticide 

products. This same methodology has 

been utilized by EPA in estimating 

dietary exposures to antimicrobial 

pesticides used in food-handling 

settings. A complete description of the 

approach used to assess dietary 

exposures resulting from food contact 

sanitizing solution uses of nitric acid 

can be found at http://

www.regulations.gov in document 

‘‘Peroxy Sulfonated Oleic Acids; Human 

Health Risk Assessment and Ecological 

Effects Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

pp. 14–15 in docket ID number EPA– 

HQ–OPP–2013–0601. EPA assessed 

dietary exposures from 9-octadecenoic 

acid (9Z)-, sulfonated, oxidized and its 

potassium and sodium salts in food as 

follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of 

PSOA were seen in the toxicity 

databases. Therefore, an acute dietary 

exposure assessment for 9-octadecenoic 

acid (9Z)-, sulfonated, oxidized and its 

potassium and sodium salts is not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, the Agency believes the 

assumptions used to estimate chronic 

dietary exposures lead to an extremely 

conservative assessment of chronic 

dietary risk due to a series of 

compounded conservative assumptions. 

First, when a surface is treated with a 

disinfectant, a quantity of the 

disinfectant remains on the surface 

(residual solution). In the absence of any 

other data, EPA has used an estimated 

worst-case concentration of 1 mg of 

residual solution per square centimeter 

(cm) of treated surface area for this 

quantity. Second, the conservatism of 

this methodology is compounded by 

EPA’s decision to assume a worst case 

scenario that all food that an individual 

consumers will come into contact with 

4,000 cm2 of sanitized non-porous food 

contact surfaces. This contact area 

represents all the surface area from 

silverware, china, and glass used by a 

person who regularly eats three meals 

per day at an institutional or public 

facility. Third, EPA assumes that 100% 

of the material present on food contact 

surfaces will migrate to food. 

2. Dietary exposure from drinking 

water. Due to the proposed use pattern, 

the Agency believes PSOA will not 

enter surface water or ground water as 

a result of the proposed use. Therefore 

a dietary exposure assessment for 

drinking water is not necessary. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure. 

Peroxy sulfonated oleic acids are not 

used as an inert ingredient in pesticide 

products that are registered for specific 

uses that may result in both indoor and 

outdoor residential exposures. 

Therefore, a residential exposure and 

risk assessment was not conducted for 

PSOA. 

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 peroxy sulfonated 

oleic acids to share a common 

mechanism of toxicity with any other 

substances, and peroxy sulfonated oleic 

acids do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that peroxy sulfonated oleic 

acids do not have a common mechanism 

of toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 


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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 

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. 

There is no concern for fetal 

susceptibility. There were no treatment 

related effects observed in a 

developmental toxicity study in rats up 

to the maximum dose tested (50 mg/kg/ 

day). Based on the corrosive nature of 

PSOA toxicity testing at doses greater 

than 100 mg/kg/day results in local 

effects (i.e., severe gastrointestinal 

irritation) with other observed systemic 

effects being secondary to the irritation 

effects. Therefore, based on the available 

data, there are no concerns for residual 

uncertainties concerning prenatal and 

postnatal toxicity. 

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 NOAEL used for risk 

assessment is based on the corrosive 

effects of PSOA which occur at dose 

levels below which any systemic 

toxicity is observed and is therefore 

protective of potential developmental 

and reproductive effects. 

ii. There is no indication that PSOA 

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 indication that PSOA 

is an immunotoxic chemical and there 

is no need for additional UFs to account 

for immunotoxicity. 

iv. There is no evidence that PSOA 

results in increased susceptibility in in 

utero rodents. 

v. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (healthprotective) assumptions regarding 

dietary exposure to PSOA. This 

assessment will not underestimate the 

exposure and risks posed by PSOA. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate SFs. 

EPA calculates the aPAD and cPAD by 

dividing the POD by all applicable UFs. 

For linear cancer risks, EPA calculates 

the probability of additional cancer 

cases 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 

POD to ensure that the MOE called for 

by the product of all applicable UFs is 

not exceeded. 

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, peroxy sulfonated 

oleic acids are 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 peroxy 

sulfonated oleic acids from food and 

water will utilize 18% of the cPAD for 

children 1–2 years old, the population 

group receiving the highest exposure. 

There are no residential uses for peroxy 

sulfonated oleic acids. Based on the 

explanation in Unit IIIC.3 residential 

use patterns, chronic residential 

exposure to residues of peroxy 

sulfonated oleic acids is not expected. 

3. 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). Because there are no 

residential uses, short-term residential 

exposures are not likely to occur, and no 

short-term adverse effect was identified 

therefore peroxy sulfonated oleic acids 

are not expected to pose a short-term 

aggregate risk. 

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). 

Because there are no residential uses, 

intermediate-term residential exposures 

are not likely to occur, and peroxy 

sulfonated oleic acids are not expected 

to pose an intermediate-term aggregate 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based upon negative 

response for mutagenicity in a battery of 

genotoxicity tests, and lack of any 

structural alerts for carcinogenicity, 

peroxy sulfonated oleic acids are 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 peroxy 

sulfonated oleic acids residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of peroxy 

sulfonated oleic acids of in or on any 

food commodities. EPA is establishing a 

limitation on the amount of peroxy 

sulfonated oleic acids that may be used 

in pesticide formulations. That 

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 

which the final end use concentration of 

peroxy sulfonated oleic acids in 

antimicrobial food contact surface 

sanitizing solutions would exceed 250 

ppm. 

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 peroxy sulfonated oleic acids. 


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Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 11593 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for residues of 

9-octadecenoic acid (9Z)-, sulfonated, 

oxidized (CAS Reg. No. 1315321–93–7); 

9-octadecenoic acid (9Z)-, sulfonated, 

oxidized, potassium salts (CAS Reg. No. 

1315321–94–8); and 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized, sodium 

salts, (CAS No. 1315321–95–9) when 

used as an inert ingredient in 

antimicrobial pesticide formulations 

used on food contact surfaces in public 

eating places, dairy processing 

equipment and food processing 

equipment and utensils at a maximum 

end-use concentration not to exceed 250 

ppm. 

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 

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: February 25, 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 § 180.940(a), alphabetically add 

the following inert ingredients to the 

table in paragraph (a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

9-Octadecenoic acid (9Z)-, sulfonated, oxidized 1315321–93–7 When ready for use, the end-use concentration is not to exceed 250 

ppm. 

9-Octadecenoic acid (9Z)-, sulfonated, oxidized, 

potassium salts.

1315321–94–8 When ready for use, the end-use concentration is not to exceed 250 

ppm. 

9-Octadecenoic acid (9Z)-, sulfonated, oxidized, 

sodium salts.

1315321–95–9 When ready for use, the end-use concentration is not to exceed 250 

ppm. 

* * * * * * * 


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11594 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 

* * * * * 

[FR Doc. 2015–04396 Filed 3–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 64 

[WC Docket No. 13–39; FCC 13–135] 

Rural Call Completion Recordkeeping 

and Reporting Requirements 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the Commission’s Report and Order 

(Order) WC Docket No. 13–39, FCC 13– 

135. This document is consistent with 

the Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing 

OMB approval and the effective date of 

the requirements. 

DATES: 47 CFR 64.2103, 64.2105, 

64.2107, and the information collection 

in paragraph 67 of this Report and 

Order, which contains information 

collection requirements published at 78 

FR 76218, December 17, 2013 are 

effective on March 4, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Randy Clarke, Acting Division Chief, 

Wireline Competition Bureau, at (202) 

418–1587. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on January 

29, 2015, OMB approved, for a period of 

three years, the information collection 

requirements contained in the 

Commission’s Order, FCC 13–135, 

published at 78 FR 76218, December 17, 

2013. The OMB Control Number is 

3060–1186. The Commission publishes 

this document as an announcement of 

the effective date of paragraphs 66 and 

67, of document WC Docket No. 13–39, 

FCC 13–135. If you have any comments 

on the burden estimates listed below, or 

how the Commission can improve the 

collections and reduce any burdens 

caused thereby, please contact Nicole 

Ongele, Federal Communications 

Commission, Room 1–620, 445 12th 

Street SW., Washington, DC 20554, or 

via email at: Nicole.Ongele@fcc.gov. 

Please include the OMB Control 

Number, 3060–1186, in your 

correspondence. The Commission also 

will accept comments via email. Please 

send them to PRA@fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on January 29, 

2015, for the information collection 

requirements contained in 64.2103, 

64.2105, and 64.2107 of the 

Commission’s Rules and the 

information collection in paragraph 67 

of the Order. 

Under 5 CFR part 1320, an agency 

may not conduct or sponsor a collection 

of information unless it displays a 

current, valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–1186. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control Number: 3060–1186. 

OMB Approval Date: January 29, 

2015. 

OMB Expiration Date: January 31, 

2018. 

Title: Rural Call Completion 

Recordkeeping and Reporting 

Requirements. 

Form Number: FCC Form 480. 

Respondents: Businesses or other forprofit entities. 

Number of Respondents and 

Responses: 225 respondents; 940 

responses. 

Estimated Time per Response: 12.5 

hours (per quarter). 

Frequency of Response: Quarterly and 

one-time reporting requirements and 

recordkeeping requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. Statutory 

authority for this information collection 

is contained in 47 U.S.C. 151, 154(i), 

201(b), 202(a), 218, 220(a), 251(a), 403. 

Total Annual Burden: 11,280 hours. 

Total Annual Cost: $793,750. 

Privacy Impact Assessment: No 

impact (s). 

Nature and Extent of Confidentiality: 

An assurance of confidentiality is not 

offered because this information 

collection does not require the 

collection of personally identifiable 

information from individuals. If the FCC 

requests that respondents submit 

information which respondents believe 

is confidential, respondents may request 

confidential treatment of such 

information pursuant to Section 0.459 of 

the FCC’s rules, 47 CFR 0.459. 

Needs and Uses: On October 28, 2013, 

the Wireline Competition Bureau 

(Bureau) of the Federal Communications 

Commission adopted a Report and 

Order (Order), in WC Docket No. 13–39; 

FCC 13–135, 78 FR 76218, Rural Call 

Completion. Under the rules adopted by 

the Order, submission of Form 480 is 

mandatory for a ‘‘covered provider’’ as 

defined in 47 CFR 64.2101(c). A covered 

provider failing to file Form 480 in a 

timely fashion may be subject to 

penalties under the Communications 

Act, including sections 502 and 503(b). 

In the Order the Commission improves 

its ability to monitor problems with 

completing calls to rural areas, and 

enforce restrictions against blocking, 

choking, reducing, or restricting calls. 

The Order applies the new rules to 

‘‘covered providers,’’ meaning providers 

of long-distance voice service that make 

the initial long-distance call path choice 

for more than 100,000 domestic retail 

subscriber lines, counting the total of all 

business and residential fixed 

subscriber lines and mobile phones and 

aggregated over all of the providers’ 

affiliates. In most cases, this is the 

calling party’s long-distance provider. 

Covered providers include LECs, 

interexchange carriers (IXCs), 

commercial mobile radio service 

(CMRS) providers, and VoIP service 

providers. These rules do not apply to 

intermediate providers. Covered 

providers must file quarterly reports and 

retain the call detail records for at least 

six calendar months. Long-distance 

voice service providers that have more 

than 100,000 domestic retail subscriber 

lines but that, for reasons set forth in 

paragraph 67 of the Order, are not 

required to file quarterly reports are 

required to file a one-time letter in WC 

Docket No. 13–39 explaining that they 

do not make the initial long-distance 

call path choice for more than 100,000 

long-distance voice service subscriber 

lines and identifying the long-distance 

provider or providers to which they 

hand off their end-user customers’ calls. 

The Order also allows qualifying 

providers to certify that they meet the 

conditions for a Safe Harbor that would 

reduce reporting and retention 

obligations. In addition, the 

Commission has delegated to the 


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