23730 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 

(b) Regulations for preventing 

significant deterioration of air quality. 

The provisions of § 52.21, except 

paragraph (a)(1), are hereby 

incorporated and made a part of the 

applicable plan for Washington for the 

facilities, emission sources, geographic 

areas, and permits listed in paragraph 

(a) of this section. For situations 

addressed in paragraph (a)(2)(i) of this 

section, the EPA will issue a Federal 

PSD permit under § 52.21 to the new 

major stationary source or major 

modification addressing PSD 

requirements applicable to GHGs for all 

subject emission units at the source, 

regardless of whether CO2 emissions 

resulted from the industrial combustion 

of biomass or from other sources of 

GHGs at the facility. For situations 

addressed in paragraph (a)(2)(ii) of this 

section, the EPA will issue a Federal 

PSD permit under § 52.21 addressing 

PSD requirements applicable to GHGs 

for each subject emissions unit that is 

permitted to emit CO2 from the 

industrial combustion of biomass. 

* * * * * 

■ 4. Section 52.2498 is amended by 

revising paragraphs (a) and (b) to read 

as follows: 

§ 52.2498 Visibility protection. 

(a) The requirements of section 169A 

of the Clean Air Act are not fully met 

because the plan does not include 

approvable procedures for visibility new 

source review for: 

(1) Facilities subject to the 

jurisdiction of the Energy Facilities Site 

Evaluation Council pursuant to Chapter 

80.50 Revised Code of Washington; 

(2) Sources subject to the jurisdiction 

of local air authorities; 

(3) Indian reservations in Washington 

except for non-trust land within the 

exterior boundaries of the Puyallup 

Indian Reservation (also known as the 

1873 Survey Area) as provided in the 

Puyallup Tribe of Indians Settlement 

Act of 1989, 25 U.S.C. 1773, and any 

other area where the EPA or an Indian 

tribe has demonstrated that a tribe has 

jurisdiction. 

(b) Regulations for visibility new 

source review. The provisions of § 52.28 

are hereby incorporated and made a part 

of the applicable plan for Washington 

for the facilities, emission sources, and 

geographic areas listed in paragraph (a) 

of this section. 

* * * * * 

[FR Doc. 2015–09889 Filed 4–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0418; FRL–9925–78] 

Phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-; Exemption From 

the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

exemption from the requirement of a 

tolerance for residues of phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl- 

(CAS Reg. No. 23328–53–2) to allow its 

use on all growing crops as an inert 

ingredient (ultraviolet (UV) stabilizer) at 

a maximum concentration of 10% in 

pesticide formulations, Loveland 

Products Inc., submitted a petition to 

EPA under the Federal Food, Drug and 

Cosmetic Act (FFDCA). This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-. 

DATES: This regulation is effective April 

29, 2015. Objections and requests for 

hearings must be received on or before 

June 29, 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–2014–0418, 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 Printing 

Office’s e-CFR site at http://www.ecfr.

gov/cgi-bin/text-idx?&c=ecfr&tpl=/

ecfrbrowse/Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under Federal Food, Drug, and 

Cosmetic Act (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–2014–0418 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 29, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0418, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 23731 

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. Background and Statutory Findings 

In the Federal Register of September 

5, 2014 (79 FR 53009) (FRL–9914–98), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP IN–10704) by 

Loveland Products, Inc., 3005 Rocky 

Mountain Avenue, Loveland, CO 80538. 

The petition requested that the 

exemption from the requirement of a 

tolerance in 40 CFR 180.920 for residues 

of phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl be amended to allow 

for use on all growing agricultural crops 

when used as an inert ingredient (UV 

stabilizer) at a maximum concentration 

of 10% weight/weight in pesticide 

formulations. That document referenced 

a summary of the petition prepared by 

the petitioner Loveland Products, Inc., 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which 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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

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 phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylincluding exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylfollows. 

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 phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl- as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

In the Federal Register of August 18, 

2010 (75 FR 50884) (FRL–8836–3), EPA 

published a final rule establishing an 

exemption from the requirement of 

tolerances for residues of phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylwhen used as an inert ingredient (UV 

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23732 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 

stabilizer) at a maximum concentration 

of 0.6% in insecticide formulations 

applied to adzuki beans, canola, 

chickpeas, cotton, fava beans, field peas, 

lentils, linola, linseed, lucerne, lupins, 

mung beans, navy beans, pigeon peas, 

safflower, sunflower, and vetch. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylas well as the NOAEL and the LOAEL 

from the toxicity studies are discussed 

in that rulemaking which can be found 

in the docket under docket ID numbers 

EPA–HQ–OPP–2008–0602. 

Since that rulemaking, as part of the 

data submitted in support of the current 

petition, an additional study has been 

submitted. In this study, a onegeneration oral reproduction study 

(OECD Test Guideline 443) with the rat, 

the NOAEL for phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylfor parental and reproductive toxicity 

was 10,000 parts per million (ppm) 

(equal to 618 milligram/kilogram/day 

(mg/kg/day), the highest dose tested 

(HDT)). The NOAEL for offspring 

toxicity was 5,000 ppm (equal to 311 

mg/kg/day) based on decreased body 

weight, body weight gain, increased 

absolute spleen weights in males and 

increased incidence of splenic extra 

medullary hematopoiesis in males at the 

LOAEL of 10,000 ppm (equal to 618 mg/ 

kg/day). Specific information on the 

study received and the nature of the 

adverse effects caused by phenol-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-, 

as well as the NOAEL and LOAEL can 

found at http://www.regulations.gov in 

the document ‘‘Phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-; 

Human Health Risk Assessment and 

Ecological Effects Assessment to 

Support Proposed Amendment to the 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Preharvest Pesticide 

Products’’ at pp. 16–19 in docket ID 

number EPA–HQ–OPP–2014–0418. 

Based on the results of this study, the 

NOAEL for parental and reproductive 

toxicity was 10,000 ppm (equal to 618 

mg/kg/day, the HDT). The NOAEL for 

offspring toxicity was 5,000 ppm (equal 

to 311 mg/kg/day) based on the 

decreased body weight, body weight 

gain, increased absolute spleen weights 

in males and increased incidence of 

splenic extra medullary hematopoiesis 

in males at 10,000 ppm (equal to 618 

mg/kg/day). 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide chemical’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. 

No acute effects were observed from 

a single dose so no acute POD was 

selected. The POD for risk assessment 

for all remaining durations and routes of 

exposure was from the 90-day toxicity 

study in rats. The NOAEL was 20 mg/ 

kg/day and the LOAEL was 40 mg/kg/ 

day based on increases in liver, kidney, 

spleen, and testes weights. Although the 

chronic point of departure was selected 

from a subchronic study, no additional 

uncertainty factor is necessary for use of 

subchronic study for chronic exposure 

assessment since available longer-term 

studies shows the lack of toxicity even 

at higher doses. A 100-fold uncertainty 

factor was used for the chronic exposure 

(10X interspecies extrapolation, 10X for 

intraspecies variability and 1X Food 

Quality Protection Act (FQPA) factor. 

The NOAEL of 20 mg/kg/day was used 

for all exposure duration via dermal and 

inhalation routes of exposure. The 

residential, occupational and aggregate 

level of concern (LOC) is for MOEs that 

are less than 100 and is based on 10X 

interspecies extrapolation, 10X for 

intraspecies variability and 1X FQPA 

factor. Dermal absorption is estimated to 

be 10% based on SAR analysis. A 100% 

inhalation absorption is assumed. 

In the Federal Register of August 18, 

2010 (75 FR 50884) (FRL–8836–3), EPA 

applied 10X FQPA factor for the lack of 

a reproduction study; however, the 

recently submitted Extended OneGeneration Reproduction Toxicity 

Study of Tinuvin 571 in Wistar Rats 

provides a reliable basis for reducing the 

FQPA factor used in the previous risk 

assessment to 1X. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to phenol, 2-(2H-benzotriazol2-yl)-6-dodecyl-4-methyl-, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from phenol, 

2-(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl- in food as follows: Because no 

acute endpoint was identified, no acute 

dietary exposure assessment was 

conducted. 

In conducting the chronic dietary 

exposure assessment using the Dietary 

Exposure Evaluation Model/Food 

Commodity Intake Database (DEEM– 

FCID)TM, Version 3.16, EPA used food 

consumption information from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA). This dietary survey 

was conducted from 2003 to 2008. As to 

residue levels in food, no residue data 

were submitted for phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-. 

In the absence of specific residue data, 

EPA has developed an approach that 

uses surrogate information to derive 

upper bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts’’ 

(D361707, S. Piper, 2/25/09) and can be 

found at http://www.regulations.gov in 

docket ID number EPA–HQ–OPP–2008– 

0738. 

In the case of phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-, 

EPA made a specific adjustment to the 

dietary exposure assessment to account 

for the use limitations of the amount of 

phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl- that may be in 

formulations (no more than 10% by 

weight in pesticide products applied to 

growing crops) and assumed that 

phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl- is present at the 

maximum limitation in all pesticide 

product formulations used on growing 

crops. 

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Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 23733 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl-, a conservative drinking water 

concentration value of 100 parts per 

billion (ppb) based on screening level 

modeling was used to assess the 

contribution to drinking water for the 

chronic dietary risk assessments for 

parent compound. These values were 

directly entered into the dietary 

exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Residential uses of pesticides 

containing phenol, 2-(2H-benzotriazol2-yl)-6-dodecyl-4-methyl- are extremely 

limited. However, in order to account 

for all of the current and unanticipated 

potential residential uses of pesticide 

products containing phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylvarious exposure models were 

employed. The Agency believes that the 

scenarios assessed represent highly 

conservative worst-case short-term and 

intermediate-term exposures and risks 

to residential handlers and those 

experiencing post-application exposure 

resulting from the use of indoor and 

outdoor pesticide products containing 

this inert ingredient in residential 

environments. Based on the use pattern, 

chronic exposure is not anticipated. 

Therefore, the risk from the chronic 

residential exposure was not assessed. 

Further details of this residential 

exposure and risk analysis can be found 

at http://www.regulations.gov in the 

memorandum entitled ‘‘JITF Inert 

Ingredients. Residential and 

Occupational Exposure Assessment 

Algorithms and Assumptions Appendix 

for the Human Health Risk Assessments 

to Support Proposed Exemption from 

the Requirement of a Tolerance When 

Used as Inert Ingredients in Pesticide 

Formulations’’ (D364751, Lloyd/LaMay, 

5/7/09) in docket ID number EPA–HQ– 

OPP–2008–0710. 

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 phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-, 

to share a common mechanism of 

toxicity with any other substances, and 

phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-, does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-, 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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. 

Developmental studies have been 

conducted on two structurally similar 

chemicals. In one study, no maternal 

toxicity was evident and the rates of 

implantation and embryo toxicity were 

not affected by treatment in rats. No 

teratogenic effects were observed; 

however, the study does not specify 

what developmental endpoints were 

examined. The NOAEL for maternal and 

developmental toxicity was 1,000 mg/

kg/day (HDT). In a separate study, there 

was no evidence of increased 

susceptibility in this developmental 

toxicity study in rats and mice at 1,000 

mg/kg/day. In a second study in rats, no 

maternal toxicity was observed at any 

dose tested. The maternal toxicity 

NOAEL was 3,000 mg/kg/day. The 

developmental NOAEL was 1,000 mg/

kg/day based on omphalocele seen in 

the one fetus in the high dose group 

(LOAEL 3,000 mg/kg/day). The data 

suggest evidence of increased 

susceptibility in this developmental 

toxicity study in rats. However, there is 

a low concern for this susceptibility 

because the adverse effect 

(omphalocele) was seen at a very high 

dose of 3,000 mg/kg/day and only in 

one fetus. In addition, the study did not 

provide historical controls that would 

assist in making a determination as to 

whether this effect is treatment related. 

No adverse reproductive effects were 

observed in a one-generation 

reproductive toxicity study in rats at 

dose levels up to 10,000 ppm; equal to 

618 mg/kg/day, the HDT. There is a 

quantitative evidence of increased 

susceptibility in the one-generation 

reproduction study in rats. In this study, 

the NOAEL for offspring toxicity was 

5,000 ppm (equal to 311 mg/kg/day) 

based on decreased body weight, body 

weight gain, increased absolute spleen 

weights in males and increased 

incidence of splenic extra medullary 

hematopoiesis in males at the LOAEL of 

10,000 ppm (equal to 618 mg/kg/day), 

while no systemic toxicity was observed 

in parental animals at doses up to 

10,000 ppm (equal to 618 mg/kg/day). 

However, the concern for this 

susceptibility is low since there is a well 

characterized NOAEL for protecting the 

offspring and the NOAEL selected for 

chronic RfD is more than 12 fold lower. 

Therefore, there is no need for 

additional uncertainty factor. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl-, is complete. Previously (2010), 

EPA identified study measuring 

reproductive parameters and lack of 

Immunotoxicity study as the data gaps. 

Since the last assessment, EPA received 

the one generation reproduction study. 

EPA concluded that the Immunotoxicity 

study is not required because the newly 

submitted study and previously 

reviewed studies do not show any 

indication of Immunotoxicity except 

one 90-day toxicity study in rats 

showing slight increases in spleen 

weights without histopathological 

findings and without changes in the 

blood parameters was observed at the 

HDT (80 mg/kg/day). Since this is an 

isolated finding, EPA concluded that the 

Immunotoxicity study is not required. 

ii. There is no indication that phenol, 

2-(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl-, is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. No clinical signs of 

neurotoxicity were seen in any of the 

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23734 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 

repeat dose studies with phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-. 

iii. No evidence of Immunotoxicity 

was seen in the available database 

except in one 90-day toxicity study in 

rats showing slight increases in spleen 

weights without histopathological 

findings and without changes in the 

blood parameters was observed at the 

HDT (80 mg/kg/day). Since this is 

isolated findings, EPA concluded that 

the Immunotoxicity study is not 

required. 

iv. There is qualitative evidence of 

post natal susceptibility in 1-generation 

reproduction study in rats, however, 

EPA concluded that there is no need for 

additional uncertainty factor since there 

is well characterized NOAEL protecting 

the offspring and the NOAEL selected 

for chronic RfD is more than 12 fold 

lower. 

v. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed using highly 

conservative model assumptions 

including 100 percent crop treated 

(PCT) and residue levels in crops 

equivalent to the highest established 

active ingredient tolerance. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl- in drinking water. EPA used 

similarly conservative assumptions to 

assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. EPA 

determines whether acute and chronic 

dietary pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute PAD (aPAD) and chronic 

PAD (cPAD). For linear cancer risks, 

EPA calculates the lifetime probability 

of acquiring cancer given the estimated 

aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

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, phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-, 

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 phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylfrom food and water will utilize 70.6% 

of the cPAD for children 1–2 years old, 

the population group receiving the 

greatest exposure: Based on the 

explanation in this unit, regarding 

residential use patterns, chronic 

residential exposure to residues of 

phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl -, 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). 

Phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-, is currently used as 

an inert ingredient in pesticide products 

that are registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methyl-,. 

Using the exposure assumptions 

described in this unit for short-term 

exposures and the use limitation 

described previously in Unit C. EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in aggregate MOEs of 170 for 

adult males and females. Adult 

residential exposure combines high-end 

dermal and inhalation handler exposure 

from liquids/trigger sprayer in home 

gardens with a high-end postapplication dermal exposure from 

contact with treated lawns. EPA has 

concluded the combined short-term 

aggregated food, water, and residential 

exposures result in an aggregate MOE of 

140 for children. Children’s residential 

exposure includes total exposures 

associated with contact with treated 

lawns (dermal and hand-to mouth 

exposures). The EPA’s level of concern 

for phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl- is for MOEs that are 

lower than 100; therefore, these MOEs 

are not of concern. 

4. Intermediate-term risk. Phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl-, is currently used as an inert 

ingredient in pesticide products that are 

registered for uses 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 phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-. 

Intermediate-term aggregate risk 

assessment was not conducted because 

short-term aggregate risk assessment is 

protective of intermediate-term 

aggregate risk since the same endpoint 

of concern has been identified for both 

exposure durations. 

5. Aggregate cancer risk for U.S. 

population. Phenol, 2-(2H-benzotriazol2-yl)-6-dodecyl-4-methyl- is not 

expected to pose a cancer risk to 

humans since there was no evidence of 

carcinogenicity in the available studies. 

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 phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl-, 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 phenol, 2-(2Hbenzotriazol-2-yl)-6-dodecyl-4-methylin or on any food commodities. EPA is 

establishing a limitation on the amount 

of phenol, 2-(2H-benzotriazol-2-yl)-6- 

dodecyl-4-methyl-, 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 that contains greater than 

10% of phenol, 2-(2H-benzotriazol-2-yl)- 

6-dodecyl-4-methyl-, by weight in the 

pesticide formulation. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for phenol, 2- 

(2H-benzotriazol-2-yl)-6-dodecyl-4- 

methyl- (CAS Reg. No. 23328–53–2) 

when used as an inert ingredient (UV 

stabilizer) at a maximum concentration 

of 10% in pesticide formulations 

applied to growing crops. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

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Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Rules and Regulations 23735 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the exemption in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 16, 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 revise the inert 

ingredient, phenol, 2-(2H-benzotriazole2-yl)-6-dodecyl-4-methyl- (CAS Reg. No. 

23328–53–2) in the table to read as 

follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Phenol, 2-(2H-benzotriazol-2-yl)-6-dodecyl-4-methyl-, (CAS Reg. No. 23328– 

53–2).

Not more than 10% by weight of pesticide 

formulations.

UV stabilizer. 

* * * * * * * 

[FR Doc. 2015–09740 Filed 4–28–15; 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–XD920 

Fisheries of the Exclusive Economic 

Zone Off Alaska; Greenland Turbot in 

the Aleutian Islands Subarea of 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 Greenland turbot in the 

Aleutian Islands subarea of the Bering 

Sea and Aleutian Islands management 

area (BSAI). This action is necessary to 

prevent exceeding the 2015 Greenland 

turbot initial total allowable catch 

(ITAC) in the Aleutian Islands subarea 

of the BSAI. 

DATES: Effective 1200 hrs, Alaska local 

time (A.l.t.), May 1, 2015, through 2400 

hrs, A.l.t., December 31, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Steve Whitney, 907–586–7228. 

SUPPLEMENTARY INFORMATION: NMFS 

manages the groundfish fishery in the 

BSAI 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 2015 Greenland turbot ITAC in 

the Aleutian Islands subarea of the BSAI 

is 170 metric tons (mt) as established by 

the final 2015 and 2016 harvest 

specifications for groundfish in the 

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

Regional Administrator has determined 

that the 2015 ITAC for Greenland turbot 

in the Aleutian Islands subarea of the 

BSAI is necessary to account for the 

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