7032 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations 

1 78 FR 79730 (Dec. 31, 2013). 

2 78 FR 79730 (Dec. 31, 2013). The Bureau 

published subsequent amendments to the TILA– 

RESPA Final Rule at 80 FR 8767 (Feb. 19, 2015) and 

80 FR 43911 (July 24, 2015). 

3Such charge is in good faith so long as such 

charge is ‘‘consistent with the best information 

reasonably available to the creditor at the time it is 

disclosed, regardless of whether the amount paid by 

the consumer exceeds the amount disclosed’’ on the 

Loan Estimate. 12 CFR 1026.19(e)(3)(iii) (emphasis 

added). 

4 78 FR 79730, 79829 (Dec. 31, 2013) (emphasis 

added). 

BUREAU OF CONSUMER FINANCIAL 

PROTECTION 

12 CFR Parts 1024 and 1026 

RIN 3170–AA19 

2013 Integrated Mortgage Disclosures 

Rule Under the Real Estate Settlement 

Procedures Act (Regulation X) and the 

Truth in Lending Act (Regulation Z); 

Correction of Supplementary 

Information 

AGENCY: Bureau of Consumer Financial 

Protection. 

ACTION: Correction of supplementary 

information. 

SUMMARY: In 2013, the Consumer 

Financial Protection Bureau (Bureau) 

issued the ‘‘Integrated Mortgage 

Disclosures Under the Real Estate 

Settlement Procedures Act (Regulation 

X) and the Truth in Lending Act 

(Regulation Z)’’ final rule (TILA–RESPA 

Final Rule).1 The Supplementary 

Information to the TILA–RESPA Final 

Rule contained a typographical error, 

which this document corrects, regarding 

the application of tolerances to property 

insurance premiums, property taxes, 

homeowner’s association dues, 

condominium fees, and cooperative 

fees. 

DATES: This correction is effective on 

February 10, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Pedro De Oliveira or David Friend, 

Counsels, Office of Regulations, 

Consumer Financial Protection Bureau, 

1700 G Street NW., Washington, DC 

20552, at (202) 435–7700. 

SUPPLEMENTARY INFORMATION: In 2013, 

the Bureau issued the ‘‘Integrated 

Mortgage Disclosures Under the Real 

Estate Settlement Procedures Act 

(Regulation X) and the Truth in Lending 

Act (Regulation Z)’’ final rule (TILA– 

RESPA Final Rule), combining certain 

disclosures that consumers receive in 

connection with applying for and 

closing on a mortgage loan.2 The 

Supplementary Information to the 

TILA–RESPA Final Rule (2013 Supp. 

Information) contained a typographical 

error, which this notice corrects. 

Specifically, on page 79829 of Volume 

78 of the Federal Register, in the first 

column, in the sentence containing 

‘‘property insurance premiums, 

property taxes, homeowner’s association 

dues, condominium fees, and 

cooperative fees,’’ the phrase ‘‘are 

subject to tolerances’’ should read ‘‘are 

not subject to tolerances.’’ 

Section 1026.19(e)(3)(iii) is titled 

‘‘Variations permitted for certain 

charges’’ and lists certain charges— 

including property insurance premiums, 

‘‘[a]mounts placed into an escrow, 

impound, reserve, or similar account,’’ 

and ‘‘[c]harges paid for third-party 

services not required by the creditor’’— 

in the category of charges not subject to 

tolerance.3 Property taxes, homeowner’s 

association dues, condominium fees, 

and cooperative fees are all ‘‘[c]harges 

paid for third-party services not 

required by the creditor.’’ Additionally, 

the 2013 Supp. Information sentence 

being corrected here is inconsistent with 

the sentence that precedes it, because 

the preceding sentence states that 

‘‘property insurance premiums are 

included in the category of settlement 

charges not subject to a tolerance, 

whether or not the insurance provider is 

a lender affiliate.’’ 4 Consequently, on 

page 79829 of the 2013 Supp. 

Information, regarding ‘‘property 

insurance premiums, property taxes, 

homeowner’s association dues, 

condominium fees, and cooperative 

fees,’’ the phrase ‘‘are subject to 

tolerances’’ should read ‘‘are not subject 

to tolerances.’’ 

Accordingly, the Bureau makes the 

following correction to FR Doc. 2013– 

28210 published on December 31, 2013 

(78 FR 79730): 

1. On page 79829, in the first column, 

in the 48th, 49th, and 50th lines, revise 

‘‘are subject to tolerances whether or not 

they are placed into an escrow, 

impound, reserve, or similar account’’ to 

read ‘‘are not subject to tolerances 

whether or not they are placed into an 

escrow, impound, reserve, or similar 

account’’. 

Dated: February 2, 2016. 

Richard Cordray, 

Director, Bureau of Consumer Financial 

Protection. 

[FR Doc. 2016–02630 Filed 2–9–16; 8:45 am] 

BILLING CODE 4810–AM–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0232; FRL–9941–15] 

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

(C10-C16) 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-, alkyl (C10- 

C16) ethers, disodium salts with a 

polyoxyethylene (POE) content 

averaging 5–15 moles, specifically CAS 

Reg. Nos. 68815–56–5, 68954–91–6, 

1013906–64–3, and 1024612–24–5, 

when used as inert ingredients 

(surfactants) in pesticide formulations 

applied to crops at a concentration not 

to exceed 10% by weight under 40 CFR 

180.910. Keller and Heckman LLP on 

behalf of Cytec Industries, Inc., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting the establishment 

of exemptions from the requirement of 

a tolerance. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of these 

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

(C10-C16) ethers, disodium salts. 

DATES: This regulation is effective 

February 10, 2016. Objections and 

requests for hearings must be received 

on or before April 11, 2016, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0232, 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 


jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations 7033 

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–2015–0232 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 11, 2016. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0232, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/

dockets. 

II. Petition for Exemption 

In the Federal Register of May 20, 

2015 (80 FR 28925) (FRL–9927–39), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10759) by Keller and 

Heckman LLP, 1001 G Street NW., Suite 

500 West, Washington, DC 20001 on 

behalf of Cytec Industries, Inc., 5 Garret 

Mountain Plaza, Woodland Park, NJ 

07424. The petition requested that 40 

CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

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

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

(C10-C16) alkylethers, disodium salts 

with a polyoxyethylene (POE) content 

averaging 5–15 specifically poly(oxy1,2-ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, C10-12-alkyl 

ethers, disodium salts, the 

poly(oxyethylene) content averages 5– 

15 moles (CAS Reg. No. 68954–91–6); 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, C10-16- 

alkyl ethers, disodium salts, the 

poly(oxyethylene) content averages 5– 

15 moles (CAS Reg, No. 68815–56–5); 

poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, C12-14- 

alkyl ethers, disodium salts, the 

poly(oxyethylene) content averages 5– 

15 moles (CAS Reg. No. 1024612–24–5); 

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

carboxy-1-oxosulfopropyl)-w- 

(isotridecyloxy)-, sodium salt (1:2), the 

poly(oxyethylene) content averages 5– 

15 moles (CAS Reg. No. 1013906–64–3) 

when used as an inert ingredient 

(surfactant) in pesticide formulations 

applied to growing crops and raw 

agricultural commodities at a 

concentration not to exceed 10% by 

weight. That document referenced a 

summary of the petition prepared by 

Keller and Heckman LLP, on behalf of 

Cytec Industries, Inc., the petitioner, 

which is available in the docket, http:// 

www.regulations.gov. Comments were 

not received on 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. . . .’’ 


jstallworth on DSK7TPTVN1PROD with RULES
7034 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations 

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-, 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-, 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-, 

alkyl (C10-C16) 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. 

The acute oral and dermal toxicity in 

rats are low for poly(oxy-1,2- 

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

oxosulfopropyl)-w-hydroxy-, -alkyl (C10- 

C16) ethers, disodium salts. They are not 

irritating to the eyes and moderately 

irritating to the skin in rabbits. They are 

weak dermal sensitizers. Acute 

inhalation toxicity studies were not 

available. 

In subchronic toxicity studies, are 

available in rats and dogs. (CAS Reg No. 

68815–56–5) was administered via the 

diet in both studies and similar effects 

are seen in both. Bodyweight decreases 

are seen in dogs at 565 milligrams/

kilogram/day (mg/kg/day) and in rats at 

4% (equivalent to 3,519 mg/kg/day, 

lowest observed adverse effect level 

(LOAEL)). Decreased feed efficiency is 

also observed at this dose in rats. The 

NOAELs are 140 mg/kg/day and 1% 

(equivalent to 770 mg/kg/day) in dogs 

and rats, respectively. The chronic 

reference dose (cRfD) is based on the 90- 

day oral toxicity study in dogs. 

The Organization for Economic 

Cooperation and Development (OECD) 

421 Reproduction/Developmental 

Toxicity Screening Test, ‘‘secondary 

alcohol ethoxylate’’, shows that 

parental, offspring and reproduction 

toxicity occur at 470 mg/kg/day. 

Maternal toxicity is manifested as 

decreased body weight and body weight 

gain, decreased food consumption, and 

clinical signs (ptosis and hypoactivity); 

offspring toxicity is manifested as 

decreased litter size, increased postimplantation loss, and microscopic 

changes of the testes and epididymides; 

and reproduction toxicity is manifested 

as a slightly increased incidence of 

microscopic changes of the testes and 

epididymides (testicular atrophy, 

increased intraluminal exfoliated 

spermatogenic cells in epididymides, 

and dilated seminiferous tubules). The 

parental, offspring and reproduction 

NOAELs are 168 mg/kg/day. Although 

fetal qualitative susceptibility is 

observed in this study, concern is low 

because it occurs only in the presence 

of maternal toxicity. Also, the cRfD is 

protective of these effects. 

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

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

alkyl (C10-C16) ethers, disodium salts are 

not expected to be carcinogenic based 

on the lack of structural alerts for 

carcinogenicity in the Derek Nexus 

analysis. Also, they are not mutagenic 

based on the Ames and chromosomal 

aberration tests. 

Neurotoxicity and immunotoxicity 

studies are not available for review. 

However, evidence of neurotoxicity and 

immunotoxicity is not observed in the 

submitted studies. 

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

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

alkyl (C10-C16) ethers, disodium salts are 

expected to be metabolized similar to 

alkyl alcohol alkoxylates. These 

metabolites are expected to be further 

metabolized through degradation of the 

ether linkage resulting in the 

corresponding alkyl alcohol and 

polyalkoxylate group which would 

undergo further oxidative degradation 

and/or excretion. Excreted materials are 

mainly lower molecular weight POElike compounds, carbon dioxide and 

water. Longer alkyl chain lengths are 

excreted at a higher proportion into 

expired air and less in urine and longer 

POE chain lengths lead to more being 

excreted via the feces and expired air. 

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 

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 90-day 

oral toxicity study in dogs was selected 

for the chronic exposure for this risk 

assessment. The NOAEL in this study 

was 140 mg/kg/day. The LOAEL was 

565 mg/kg/day based on decreased 

bodyweight. 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 FQPA safety 

factor of 10X was reduced to 1X. 


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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-, alkyl (C10-C16) ethers, 

disodium salts, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

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

(C10-C16) 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-, 

alkyl (C10-C16) ethers, disodium salts can 

occur following ingestion of foods with 

residues from treated crops. Because no 

adverse effects attributable to a single 

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

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

disodium salts are 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 10% by 

weight in pesticide formulations. 

2. Dietary exposure from drinking 

water. For the purpose of the screeninglevel 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-, alkyl (C10- 

C16) ethers, disodium salts, a 

conservative drinking water 

concentration value of 100 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). 

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

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

alkyl (C10-C16) ethers, disodium salts 

may be used in inert ingredients in 

products that are registered for specific 

uses that may result in residential 

exposure, such as pesticides used in and 

round the home, personal (care) 

products, and cosmetics. The Agency 

conducted an assessment to represent 

worst-case residential exposure by 

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

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

alkyl (C10-C16) ethers, disodium salts in 

pesticideformulations (outdoor 

scenarios) and in disinfectant-type uses 

(indoor scenarios). 

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 poly(oxy-1,2- 

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

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) 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 (C10- 

C16) ethers, disodium salts do 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-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl 

(C10-C16) ethers, disodium salts 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 

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. 

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

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

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) ethers, disodium salts contains two 

subchronic studies, a reproduction/

developmental toxicity screening study, 

and mutagenicity studies. There is no 

indication of neurotoxicity or 

immunotoxicity in the available studies; 

therefore, there is no need to require 

neurotoxicity or immunotoxicity 

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 cRfD, 1.40 mg/ 

kg/day, will be protective of fetal effects. 

In addition, the Agency used 

conservative exposure estimates, with 

100 percent crop treated, tolerance-level 

residues, conservative drinking water 

modeling numbers, and a worst-case 

assessment of potential residential 

exposure for infants and children. 

Therefore, the FQPA SF of 10X is 

reduced to 1X. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

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

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

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) 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 (C10- 

C16) ethers, disodium salts from food 

and water will utilize 10.3% of the 


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7036 Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations 

cPAD for children 1 to 2 years old, the 

population group receiving the greatest 

exposure. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

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

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

alkyl(C10-C16) ethers, disodium salts 

may be used as inert ingredients in 

pesticide products that could result in 

short-term residential exposure and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

short-term residential exposures to 

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

(C10-C16) ethers, disodium salts. Using 

the exposure assumptions described 

above, EPA has concluded that the 

combined short-term aggregated food, 

water, and residential exposures result 

in MOEs of 151 for both adult males and 

females respectively. Adult residential 

exposure combines high-end dermal 

and inhalation handler exposure from 

indoor hard surface, wiping with a highend post application dermal exposure 

from contact with treated lawns. As the 

level of concern is for MOEs that are 

lower than 100, this MOE is not of 

concern. EPA has concluded the 

combined short-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 430 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

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

concern is for MOEs that are lower than 

100, this MOEs is not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

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

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

alkyl (C10-C16) ethers, disodium salts 

may be used as inert ingredients in 

pesticide products that could result in 

intermediate-term residential exposure 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

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

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

alkyl (C10-C16) ethers, disodium salts. 

Using the exposure assumptions 

described above, EPA has concluded 

that the combined intermediate-term 

aggregated food, water, and residential 

exposures result in aggregate MOEs of 

1637 for adult males and females. Adult 

residential exposure combines Indoor 

hard surface, wiping with a high end 

post application dermal exposure from 

contact with treated lawns. As the level 

of concern is for MOEs that are lower 

than 100, this MOE is not of concern. 

EPA has concluded the combined 

intermediate-term aggregated food, 

water, and residential exposures result 

in an aggregate MOE of 597 for children. 

Children’s residential exposure includes 

total exposures associated with contact 

with treated surfaces (dermal and handto-mouth exposures). As the level of 

concern is for MOEs that are lower than 

100, this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on a DEREK 

structural alert analysis and the lack of 

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

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

disodium salts are considered 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 poly(oxy-1,2- 

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

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) ethers, disodium salts residues. 

V. Other Considerations 

Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

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

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

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) ethers, disodium salts in or on any 

food commodities. EPA is establishing a 

limitation on the amount of poly(oxy1,2-ethanediyl), a-(3-carboxy-1- 

oxosulfopropyl)-w-hydroxy-, alkyl (C10- 

C16) ethers, disodium salts that may be 

used in pesticide formulations applied 

to growing crops. 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 

formulation for use on growing crops for 

sale or distribution that exceed 10% of 

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

(C10-C16) ethers, disodium salts. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for the following 

when used as inert ingredients 

(surfactants) in pesticide products at a 

concentration not to exceed 10% 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 


jstallworth on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 81, No. 27 / Wednesday, February 10, 2016 / Rules and Regulations 7037 

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 19, 2016. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.910, add alphabetically the 

following inert ingredient(s) to the table 

to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C10-12-alkyl 

ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS 

Reg. No. 68954–91–6).

Not to exceed 10% by weight of pesticide 

formulation.

Surfactant. 

* * * * * * * 

Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C10-16-alkyl 

ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS 

Reg, No. 68815–56–5).

Not to exceed 10% by weight of pesticide 

formulation.

Surfactant. 

* * * * * * * 

Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, C12-14-alkyl 

ethers, disodium salts, the poly(oxyethylene) content averages 5–15 moles (CAS 

Reg. No. 1024612–24–5).

Not to exceed 10% by weight of pesticide 

formulation.

Surfactant. 

* * * * * * * 

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

salt (1:2), the poly(oxyethylene) content averages 5–15 moles (CAS Reg. No. 

1013906–64–3).

Not to exceed 10% by weight of pesticide 

formulation.

Surfactant. 

* * * * * * * 

[FR Doc. 2016–02569 Filed 2–9–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

[Docket No. 141021887–5172–02] 

RIN 0648–XE430 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Pacific Cod by 

Catcher Vessels Less Than 60 Feet 

(18.3 Meters) Length Overall Using 

Hook-and-Line or Pot Gear in the 

Bering Sea and Aleutian Islands 

Management Area 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS is prohibiting directed 

fishing for Pacific cod by catcher vessels 

less than 60 feet (18.3 meters (m)) length 

overall (LOA) using hook-and-line or 

pot gear in the Bering Sea and Aleutian 

Islands management area (BSAI). This 

action is necessary to prevent exceeding 

the 2016 Pacific cod total allowable 

catch allocated to catcher vessels less 

than 60 feet (18.3 m) LOA using hookand-line or pot gear in the BSAI. 

DATES: Effective 1200 hours, Alaska 

local time (A.l.t.), February 5, 2016, 

through 2400 hours, A.l.t., December 31, 

2016. 

FOR FURTHER INFORMATION CONTACT: Josh 

Keaton, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI exclusive economic zone 

according to the Fishery Management 

Plan for Groundfish of the Bering Sea 

and Aleutian Islands Management Area 

(FMP) prepared by the North Pacific 

Fishery Management Council under 

authority of the Magnuson-Stevens 

Fishery Conservation and Management 

Act. Regulations governing fishing by 

U.S. vessels in accordance with the FMP 

appear at subpart H of 50 CFR part 600 

and 50 CFR part 679. 

The 2016 Pacific cod total allowable 

catch (TAC) allocated to catcher vessels 

less than 60 feet (18.3 m) LOA using 

hook-and-line or pot gear in the BSAI is 

6,226 metric tons (mt) as established by 

the final 2015 and 2016 harvest 

specifications for groundfish in the 

BSAI (80 FR 11919, March 5, 2015), 

inseason adjustment (81 FR 184, January 

5, 2016), and reallocation (81 FR 5627, 

February 3, 2016). 


jstallworth on DSK7TPTVN1PROD with RULES