5952 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem 

(subgroup 5A) ................. 1 .5 

Brassica, leafy greens (subgroup 5B) ........................ 7 .0 

* * * * * 

Cattle, liver .......................... 1 .0 

* * * * * 

Cotton, gin byproducts ....... 6 .0 

Cotton, undelinted seed ..... 0 .50 

* * * * * 

Egg ..................................... 0 .01 

* * * * * 

Goat, liver ........................... 1 .0 

* * * * * 

Grain, aspirated fractions ... 6 .0 

* * * * * 

Hog, meat byproducts ........ 0 .05 

* * * * * 

Horse, liver ......................... 1 .0 

* * * * * 

Lettuce, head ...................... 1 .5 

* * * * * 

Milk ..................................... 0 .02 

* * * * * 

Poultry, fat .......................... 0 .01 

Poultry, meat byproducts .... 0 .01 

Radicchio ............................ 1 .5 

* * * * * 

Sheep, liver ......................... 1 .0 

* * * * * 

Sorghum, grain, forage ....... 2 .0 

Sorghum, grain, grain ......... 1 .5 

Sorghum, grain, stover ....... 6 .0 

* * * * * 

Vegetable, leafy, except 

Brassica, crop group 4, 

except head lettuce and 

radicchio .......................... 10 

* * * * * 

* * * * * 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. 2015–02177 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0514; FRL–9920–44] 

Poly(oxy-1,2-ethanediyl), α-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16) -alkyl ethers, disodium salts; 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16) 

alkyl ethers, disodium salts when used 

as an inert ingredient (surfactant) in 

pesticide formulations applied to 

growing crops (seed treatment use only) 

under 40 CFR 180.920 at a 

concentration not to exceed 0.125% by 

weight. BASF submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16) alkyl ethers, 

disodium salts. 

DATES: This regulation is effective 

February 4, 2015. Objections and 

requests for hearings must be received 

on or before April 6, 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–2014–0514, 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. 

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–2014–0514 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 April 6, 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 


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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– 

2014–0514, 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 

5, 2014 (79 FR 53009) (FRL–9914–98), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10671) by BASF, 26 

Davis Dr., Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C12) alkyl ethers, disodium salts, 

polyethoxylation content averages 4–5 

moles, Chemical Abstracts Service 

Registry Number (CAS Reg. No.) 68954– 

91–6 and poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts, 

polyethoxylation content averages 5 

moles (CAS Reg. No. 68815–56–5), 

when used as an inert ingredient 

(surfactant) in pesticide formulations 

applied to growing crops (seed 

treatment use only) at a concentration 

not to exceed 0.125% by weight under 

40 CFR 180.920. That document 

referenced a summary of the petition 

prepared by Exponent on behalf of 

BASF, the petitioner, which is available 

in the docket, http://

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit V.C. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(c)(2)(A)(i) of FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue . . .’’ 

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 poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts as 

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

toxicity studies are discussed in this 

unit. 

Poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts 

include CAS Reg. No. 68815–56–5, 

which consists of a C10–C16 linear 

carbon chain and average 

polyethoxylation (POE) = 4.5 and CAS 

Reg. No. 68954–91–6, which consists of 

a C10–C12 linear alkyl carbon chain and 

average polyethoxylation (POE) = 5. 

Although data are not available for CAS 

Reg. No. 68954–91–6, EPA relied on 

available subchronic toxicity studies on 

CAS Reg. No. 68815–56–5. These 

studies are sufficient to assess the 

subchronic toxicity of CAS Reg. No. 

68954–91–6 as the only difference 

between the compounds is the range of 

carbon chain lengths and the testing of 

the broader carbon chain length of C10– 

C16 in CAS Reg. No. 68815–56–5 would 

include any effects that might be seen in 

tests of the narrower linear carbon chain 


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length of C10–C12 (in CAS Reg. No. 

68954–91–6). Reproduction and 

developmental toxicity studies were not 

available for review for either 

compound, so reproduction data for 

C12AE6 (CAS Reg. No. 9002–92–0), 

which is similar to poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts in carbon 

chain length and average ethoxylation, 

were used as surrogate data for potential 

reproductive effects of CAS Reg. Nos. 

68815–56–5 and 68954–91–6. Based on 

analogy to well-known metabolic 

pathways for other linear alkyl ethers, 

the major pathway in the primary 

metabolism of both compounds is 

expected to be oxidative-reductive ether 

cleavage. Therefore, the metabolism of 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16)-alkyl ethers, disodium salts would 

result in the formation of the 

corresponding alkyl alcohol alkoxylate 

such as C12AE6 (CAS Reg. No. 9002– 

92–0). 

The acute oral and dermal toxicity of 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16)-alkyl ethers, disodium salts is low 

(toxicity category IV). The Lethal Dose 

(LD)50 is >5,000 milligram/kilogram 

(mg/kg) in the rat (oral) and rabbit 

(dermal). They are irritating to the eyes 

and non-irritating to the skin in rabbits. 

They are not dermal sensitizers. Acute 

inhalation toxicity studies were not 

available. 

Subchronic toxicity studies were 

available in the rat and dog for CAS Reg 

No. 68815–56–5. CAS Reg No. 68815– 

56–5 was administered via the diet in 

both studies. In a 90-day oral toxicity 

study in rats, decreased body weight 

gain was observed at 4% (equivalent to 

2,000 mg/kg/day (LOAEL)) of CAS Reg 

No. 68815–56–5. The NOAEL was 1% 

(equivalent to 500 mg/kg/day). In a 90- 

day toxicity study in dogs, toxicity was 

not observed at 500 mg/kg/day 

(NOAEL), the highest dose tested. 

An acceptable developmental toxicity 

study is not available; however, in a 2- 

generation reproduction study in rats on 

C12AE6, decreased body weight gain 

was observed in parental animals at 

0.5% (equivalent to 250 mg/kg/day). 

The NOAEL was 0.1% (equivalent to 50 

mg/kg/day). Offspring toxicity was 

manifested as decreased weight gain in 

pups, increased embryo lethality and 

soft tissue anomalies at 0.5% 

(equivalent to 250 mg/kg/day). The 

NOAEL was 0.1% (equivalent to 50 mg/ 

kg/day). Although fetal qualitative 

susceptibility is observed in this study, 

the concern is low because effects 

occurred only in the presence of 

maternal toxicity. 

Chronic/carcinogenicity studies with 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts were not 

available. However, a DEREK structural 

alert analysis was conducted with 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C12)-alkyl ethers, disodium salt (CAS 

Reg No. 68954–91–6) and indicated no 

structural alerts for carcinogenicity or 

mutagenicity. Therefore, poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts are not expected 

to be carcinogenic. 

Mutagenicity studies were not 

available for poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers, 

disodium salts. However, an Ames test 

is available on CAS Reg. No. 68439–50– 

9, a surrogate alkyl alcohol alkoxylate. 

The test was negative. 

Neurotoxicity studies were not 

available for review. Although ataxia 

was observed in the dams in the 

developmental toxicity study in rabbits 

at 100 mg/kg/day, the onset and 

persistence of ataxia were not reported 

and thus could not be evaluated. Since 

evidence of ataxia or other signs of 

potential neurotoxicity were not 

observed in the subchronic studies 

conducted with rats or dogs at doses 

≥500 mg/kg/day, it was concluded that 

the ataxia observed in the dams was not 

likely a result of neurotoxicity. 

Immunotoxicity studies were not 

available for review. However, evidence 

of immunotoxicity was not observed in 

the submitted studies. 

Metabolism studies on poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts were not 

available for review. However, based on 

analogy to known metabolic pathways 

for linear alkyl ethers, the major 

pathway in the primary metabolism is 

expected to be oxidative-reductive ether 

cleavage. Therefore, the primary 

metabolism of poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl ethers, disodium salts 

occurs via oxidative-reductive ether 

hydrolysis resulting in the formation of 

linear alkyl alcohols and polyethylene 

glycol metabolites. The alcohols would 

undergo oxidation by alcohol 

dehydrogenase and aldehyde 

dehydrogenase to generate a fatty acid 

metabolite that is degraded by boxidation to carbon dioxide (CO2) and 

water (H2O). The polyethylene glycol 

metabolites would be degraded via 

oxidation by alcohol dehydrogenase and 

aldehyde dehydrogenase to generate a 

dienoic polyethylene ether acid that 

may be conjugated and excreted. Also, 

the alcohol function may be sulfated by 

sulfotransferases and excreted. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which the NOAEL and the 

LOAEL are identified. Uncertainty/

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

An acute effect was not found in the 

database therefore an acute dietary 

assessment is not necessary. The 2- 

generation reproduction study in the rat 

was selected for the chronic exposure 

for this risk assessment. The NOAEL in 

this study was 50 mg/kg/day. The 

LOAEL was 250 mg/kg/day based on 

decreased weight gain. This study 

represents the lowest NOAEL in the 

database in the most sensitive species. 

The dermal and inhalation absorption 

rates were assumed to be 100%. The 

standard inter- and intra-species 

uncertainty factors were applied. The 

Food Quality Protection Act Safety 

Factor (FQPA SF) of tenfold (10X) was 

retained for the lack of a developmental 

toxicity study. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to poly(oxy-1,2-ethanediyl), a- 

(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers, 

disodium salts, EPA considered 

exposure under the proposed exemption 


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from the requirement of a tolerance. 

EPA assessed dietary exposures from 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16)-alkyl ethers, disodium salts in food 

as follows: 

Dietary exposure (food and drinking 

water) to poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts 

can occur following ingestion of foods 

with residues from seed-treated crops. 

Because no adverse effects attributable 

to a single exposure of poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts were seen in 

the toxicity databases, an acute dietary 

risk assessment is not necessary. For the 

chronic dietary risk assessment, EPA 

used the Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCIDTM), Version 3.16, and food 

consumption information from the U.S. 

Department of Agriculture’s (USDA’s) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). One 

hundred percent crop treated was 

assumed, default processing factors, and 

tolerance-level residues for all foods and 

use limitations of not more than 0.125% 

by weight in pesticide formulations. 

2. Cancer. A DEREK structural alert 

analysis indicated no structural alerts 

for carcinogenicity or mutagenicity. 

Therefore, poly(oxy-1,2-ethanediyl), a- 

(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers, 

disodium salts are not expected to be 

carcinogenic and a cancer risk 

assessment is unnecessary. 

3. 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 poly(oxy1,2-ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts, a 

conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

4. 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, and 

tables). 

Poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts 

are not expected to result in residential 

exposure based on its use pattern as a 

seed treatment for agricultural crops. 

5. 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 poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts to share a 

common mechanism of toxicity with 

any other substances, and poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl ethers, disodium salts 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional 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 SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

The toxicity database for poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts contains two 

subchronic studies, a reproductive 

toxicity study, a developmental toxicity 

study and mutagenicity studies. 

Qualitative fetal susceptibility was 

observed in the 2-generation toxicity 

study in rats. However, concern for fetal 

effects are low since they only occurred 

in the presence of maternal toxicity and 

protecting against maternal toxicity will 

subsequently prevent fetal toxicity. In 

addition, the chronic reference dose 

(cRfD) was based on this study and will 

be protective of fetal effects. However, 

since the developmental study in rabbits 

was unacceptable, the FQPA SF of 10X 

was retained to account for an 

incomplete database. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl 

ethers, disodium salts from food and 

water will utilize 16.2% of the cPAD for 

non-nursing infants, the population 

group receiving the greatest exposure. 

There are no residential uses for 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10– 

C16)-alkyl ethers, disodium salts. 

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). Since poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts have no 

uses that would result in short-term 

residential exposure, the Agency has 

determined that it is appropriate to 


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5956 Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 

aggregate chronic exposure through food 

and water only. 

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). 

Since poly(oxy-1,2-ethanediyl), a-(3- 

carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts 

have no uses that would result in 

intermediate-term residential exposure, 

the Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water only. 

5. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis and the lack of 

mutagenicity, poly(oxy-1,2-ethanediyl), 

a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers, 

disodium salts are considered not likely 

to be carcinogenic. 

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 poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. Response to Comments 

A comment was received from a 

private citizen who was concerned 

about the reaction of fatty acid esters to 

any future chemicals added to the 

environment. The Agency understands 

the commenter’s concerns and 

recognizes that some individuals believe 

that no residue of pesticides should be 

allowed because of potential 

interactions with other chemicals. 

However, under the existing legal 

framework provided by FFDCA section 

408, EPA is authorized to establish 

pesticide tolerances or exemptions 

where persons seeking such tolerances 

or exemptions have demonstrated that 

the pesticide meets the safety standard 

imposed by the statute, which EPA has 

determined here. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for poly(oxy-1,2- 

ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, (C10–C16)- 

alkyl ethers, disodium salts (CAS Reg. 

Nos. 68954–91–6 and 68815–56–5) 

when used as inert ingredients 

(surfactant) in pesticide products used 

for seed treatment only at a 

concentration not to exceed 0.125% in 

the end-use formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions to 

the requirement for 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: January 15, 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 to 

the table after ‘‘Poly(oxy-1,2- 

ethanediyl),a-isotridecyl-w-methoxy 

(CAS Reg. No. 345642–79–7)’’ the two 

inert ingredients listed below to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 


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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations 5957 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C12)-alkyl ethers, disodium salts, polyoxylene content averages 4–5 moles (CAS Reg. No. 68815–56–5).

Not to exceed 0.125% for seed 

treatment use only.

Surfactant. 

Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, 

(C10–C16)-alkyl ethers, disodium salts, polyoxyethylene content averages 5 moles (CAS Reg. No. 68954–91–6).

Not to exceed 0.125% for seed 

treatment use only.

Surfactant 

* * * * * * * 

[FR Doc. 2015–02072 Filed 2–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1983–0002; FRL–9922– 

37–Region–2] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List: Partial 

Deletion of the Fulton Terminals 

Superfund Site 

AGENCY: United States Environmental 

Protection Agency. 

ACTION: Direct final rule. 

SUMMARY: The Fulton Terminals 

Superfund site (Site), located in the City 

of Fulton, Oswego County, New York, 

consists of an ‘‘On-Property’’ portion, an 

approximately 1.5-acre parcel of land 

bounded on the west by First Street, on 

the south by Shaw Street, on the east by 

New York State Route 481, and on the 

north by a warehouse, and an ‘‘OffProperty’’ portion, defined by the area 

between the On-Property portion’s 

western property boundary to the 

Oswego River (approximately 50 feet). 

The Environmental Protection Agency 

(EPA) Region 2, is publishing this direct 

final Notice of Partial Deletion (NOPD) 

of the On-Property portion of the Site 

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). This direct 

final partial deletion is being published 

by EPA with the concurrence of the 

State of New York, through the New 

York State Department of 

Environmental Conservation (NYSDEC), 

because EPA has determined that all 

appropriate response actions under 

CERCLA have been completed at the 

On-Property portion of the Site and that 

the soil on the On-Property portion of 

the Site and the groundwater beneath 

the On-Property portion of the Site no 

longer pose a threat to public health or 

the environment. The NOPD pertains to 

the On-Property portion of the Site. The 

Off-Property portion of the Site will 

remain on the NPL. Because residual 

groundwater contamination remains in 

the Off-Property portion of the Site, 

groundwater monitoring and five-year 

reviews will still be required for this 

area. The partial deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final partial deletion 

will be effective April 6, 2015 unless 

EPA receives adverse comments by 

March 6, 2015. If adverse comments are 

received, EPA will publish a timely 

withdrawal of this direct final NOPD in 

the Federal Register, informing the 

public that the partial deletion will not 

take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1983–0002, by one of the 

following methods: 

Web site: http://www.regulations.gov. 

Follow the on-line instructions for 

submitting comments. 

Email: tsiamis.christos@epa.gov. 

Fax: To the attention of Christos 

Tsiamis at 212–637–3966. 

Mail: To the attention of Christos 

Tsiamis, Remedial Project Manager, 

Emergency and Remedial Response 

Division, U.S. Environmental Protection 

Agency, Region 2, 290 Broadway, 20th 

Floor, New York, NY 10007–1866. 

Hand Delivery: Superfund Records 

Center, 290 Broadway, 18th Floor, New 

York, NY 10007–1866 (telephone: 212– 

637–4308). Such deliveries are only 

accepted during the Record Center’s 

normal hours of operation (Monday to 

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

Special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1983– 

0002. EPA’s policy is that all comments 

received will be included in the Docket 

without change and may be made 

available online at http://

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http://

www.regulations.gov or via email. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your 

comments. If you send comments to 

EPA via email, your email address will 

be included as part of the comment that 

is placed in the Docket and made 

available on the Web site. If you submit 

electronic comments, EPA recommends 

that you include your name and other 

contact information in the body of your 

comments and with any disks or CD– 

ROMs that you submit. If EPA cannot 

read your comments because of 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comments fully. 

Electronic files should avoid the use of 

special characters and any form of 

encryption and should be free of any 

defects or viruses. 

Docket: 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 hard 

copy. Publicly-available Docket 

materials can be obtained either 

electronically at http://

www.regulations.gov or in hard copy at: 

U.S. Environmental Protection 

Agency, Region 2, Superfund Records 

Center, 290 Broadway, 18th Floor, New 

York, NY 10007–1866, Phone: 212–637– 

4308, Hours: Monday to Friday from 

9:00 a.m. to 5:00 p.m. and Fulton Public 

Library, 160 South First Street, Fulton, 

NY 13069, Phone: 315–592–5159, 

Hours: Tue–Thu: 9:00 a.m.–7:00 p.m., 


tkelley on DSK3SPTVN1PROD with RULES