61118 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 

comment in response to the parallel 

notice of proposed rulemaking for this 

action published in the proposed rules 

section of today’s Federal Register, 

rather than file an immediate petition 

for judicial review of this direct final 

rule, so that EPA can withdraw this 

direct final rule and address the 

comment in the proposed rulemaking. 

This action may not be challenged later 

in proceedings to enforce its 

requirements. (See section 307(b)(2)) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Lead, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Sulfur oxides, Volatile 

organic compounds. 

Dated: September 21, 2015. 

H. Curtis Spalding, 

Regional Administrator, EPA New England. 

Part 52 of chapter I, title 40 of the 

Code of Federal Regulations is amended 

as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart U—Maine 

■ 2. In § 52.1020(c), the table is 

amended by adding new state citations 

for Chapter 149 and Chapter 164 in 

numerical order and revising footnote 1 

to read as follows: 

§ 52.1020 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED MAINE REGULATIONS

State citation Title/subject State effective 

date 

EPA approval date EPA 

approval date 

and citation 1

Explanations 

*******

Chapter 149 ............ General Permit Regulation for 

Nonmetallic Mineral Processing Plants.

04/27/2014 10/9/2015, [Insert Federal 

Register citation].

All of Chapter 149 is approved with the 

exception of the ‘‘director discretion’’ 

provisions in sections 5(A)(8), 

5(A)(9)(a), and 5(A)(9)(b), and the 

opacity provisions in sections 

5(A)(15), 5(C)(7), and 5(E), which 

were formally withdrawn from consideration as part of the SIP. 

* * * * * * * 

Chapter 164 ............ General Permit Regulation for 

Concrete Batch Plants.

04/27/2014 10/9/2015, [Insert Federal 

Register citation].

All of Chapter 164 is approved with the 

exception of the ‘‘director discretion’’ 

provisions in sections 5(C)(2), 

5(C)(3)(a), and 5(C)(3)(b), and the 

opacity provisions in sections 

5(A)(10), 5(B)(3), 5(B)(4), 5(E), 

5(F)(5) and 5(G)(4), which were formally withdrawn from consideration 

as part of the SIP. 

* * * * * * * 

1 In order to determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for the particular provision. 

[FR Doc. 2015–25446 Filed 10–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0043; FRL–9934–74] 

Trans-1,3,3,3-tetrafluoroprop-1-ene; 

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 trans-1,3,3,3- 

tetrafluoroprop-1-ene (CAS Reg. No. 

29118–24–9) when used as an inert 

ingredient (propellant) in pesticide 

formulations applied to growing crops, 

raw agricultural commodities after 

harvest, and animals, and when used as 

an inert ingredient in antimicrobial 

pesticide formulations for food-contact 

surface sanitizing solutions. The Acta 

Group, L.L.C. on behalf of Honeywell 

International, Inc. submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of trans-1,3,3,3- 

tetrafluoroprop-1-ene. 

DATES: This regulation is effective 

October 9, 2015. Objections and 

requests for hearings must be received 

on or before December 8, 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–2012–0043, 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., 


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Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 61119 

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–2012–0043 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 December 8, 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– 

2012–0043, 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 April 4, 

2012 (77 FR 20334) (FRL–9340–4), EPA 

issued a document pursuant to FFDCA 

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

the filing of a pesticide petition (PP 

1E7938) by The Acta Group, L.L.C. 

(2200 Pennsylvania Avenue NW., Suite 

100W, Washington, DC 20037) on behalf 

of Honeywell International, Inc., 101 

Columbia Road, Morristown, NJ 07962. 

The petition requested that 40 CFR 

180.910, 180.930 and 180.940(a) be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of trans-1,3,3,3-tetrafluoroprop1-ene (CAS Reg. No. 29118–24–9) when 

used as an inert ingredient (propellant) 

in pesticide formulations applied to 

growing crops, raw agricultural 

commodities after harvest, and animals, 

and when used as an inert ingredient in 

antimicrobial pesticide formulations for 

food-contact surface sanitizing 

solutions, respectively. That document 

referenced a summary of the petition 

prepared by The Acta Group, L.L.C. on 

behalf of Honeywell International, Inc., 

the petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

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

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 


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61120 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 

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 trans-1,3,3,3- 

tetrafluoroprop-1-ene including 

exposure resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with trans-1,3,3,3- 

tetrafluoroprop-1-ene 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 trans-1,3,3,3-tetrafluoroprop-1-ene 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. 

Acute inhalation toxicity is low for 

trans-1,3,3,3-tetrafluoroprop-1-ene. 

Acute inhalation LD50s are >101,850 

parts per million (ppm); approximately 

713 milligram/kilogram (mg/kg) in rats 

and mice. Trans-1,3,3,3-tetrafluoroprop1-ene is not a dermal irritant in rabbits 

or a sensitizer in humans. 

Two subchronic toxicity studies via 

the inhalation route of exposure are 

available for trans-1,3,3,3- 

tetrafluoroprop-1-ene in rodents. 

Toxicity is not observed in rats or mice 

at doses as high as 5,000 ppm 

(approximately equivalent to 7,800 

milligram/kilogram/day (mg/kg/day) 

human equivalent dose) following 13 

weeks and 90 days of exposure, 

respectively. The 90-day inhalation 

toxicity study in mice also evaluated the 

carcinogenic potential of trans-1,3,3,3- 

tetrafluoroprop-1-ene by conducting a 

toxicogenomic assessment. Trans1,3,3,3-tetrafluoroprop-1-ene is 

classified as non-carcinogenic by the 

toxicogenomic assessment at 10,000 

ppm (approximately equivalent to 

15,600 mg/kg/day human equivalent 

dose), the highest dose tested (HDT). 

Developmental toxicity studies via the 

inhalation route are available in rats and 

rabbits. Neither maternal nor 

developmental toxicity is observed in 

either study up to 15,000 ppm 

(approximately equivalent to 23,400 mg/ 

kg/day human equivalent dose), the 

HDT. 

Two Ames Tests via gas exposure are 

available for review with trans-1,3,3,3- 

tetrafluoroprop-1-ene. The mouse 

micronucleus assay was performed via 

inhalation exposure. These tests are 

negative. 

A chronic study with trans-1,3,3,3- 

tetrafluoroprop-1-ene is not available for 

review. Although a chronic toxicity 

study is not available, there is no 

concern for the lack of it because 

toxicity is not seen following up to 13 

weeks of exposure to trans-1,3,3,3- 

tetrafluoroprop-1-ene at excessive doses 

(7,800 and 15,600 mg/kg/day). Also, 

toxicity is not seen in the 

developmental study at an excessive 

dose of 23,400 mg/kg/day. Therefore, 

the likelihood that chronic exposure to 

doses below the limit dose will result in 

toxic effects is highly unlikely. 

Neurotoxicity studies are not 

available for review. However, evidence 

of neurotoxicity is not observed in the 

submitted inhalation studies. 

Immunotoxicity studies are not 

available for review. However, very 

slight mononuclear cell infiltrates in the 

heart are observed in only females (3/5) 

at the LOAEL of ≥5,000 ppm 

(approximately 7,800 mg/kg/day human 

equivalent dose lowest dose tested) 

following 10 days of exposure via 

inhalation in Sprague Dawley rats. This 

effect is not dose dependent with regard 

to either incidence or severity. Similar 

effects along with increased monocyte 

count are observed in the heart at 15,000 

ppm (approximately 23,400 mg/kg/day 

human equivalent dose; HDT) in a 13- 

week study via inhalation in Sprague 

Dawley rats. The NOAEL is 5,000 ppm 

(equivalent to 7,800 mg/kg/day human 

equivalent dose). This study included 

more rats, is conducted in the same 

species of rats that underwent the same 

route of exposure and was of longer 

duration (13 weeks vs 10 days). 

Mononuclear cell infiltrates in the heart 

are not observed at 5,000 ppm 

(equivalent to 7,800 mg/kg/day human 

equivalent dose) in either the male or 

female rat as was observed in the 10-day 

study. Therefore, since the incidence 

and severity of these effects are not 

dose-dependent in the 10-day study, the 

13-week study is considered more 

reflective of toxicity resulting from 

exposure to trans-1,3,3,3- 

tetrafluoroprop-1-ene. However, the 

Agency is not concerned about these 

effects since they occur well above the 

limit dose and exposure above that is 

highly unlikely and unrealistic. 

Two studies are available for trans1,3,3,3-tetrafluoroprop-1-ene on male 

rats and mice metabolism and 

pharmacokinetics. In rats and mice, 

trans-1,3,3,3-tetrafluoroprop-1-ene via 

the inhalation route of exposure is 

rapidly absorbed, metabolized and 

excreted. The urine is the major route of 

excretion. In rats, the major metabolite 

is S-(3,3,3-trifluoro-trans-propenyl)- 

mercaptolactic acid. In mice, the major 

metabolite is a presumed amino acid 

conjugate of 3, 3, 3-trifluoropropionic 

acid. Other identified metabolites are S- 

(3, 3, 3-trifluoro-transpropenyl)-Lcysteine, N-acetyl-S-(3,3,3-trifluorotrans-propenyl)-L-cysteine and 3,3,3- 

trifluoropropionic acid. 

Specific information on the studies 

received on trans-1,3,3,3- 

tetrafluoroprop-1-ene as well as the noobserved-adverse-effect level (NOAEL) 

and the lowest- observed- adverse-effect 

level (LOAEL) from the toxicity studies 

can be found at http://

www.regulations.gov in the document, 

‘‘Trans-1,3,3,3-tetrafluoroprop-1-ene; 

Human Health Risk Assessment and 

Ecological Effects Assessment to 

Support Proposed Exemption from the 

Requirement of a Tolerance When Used 

as Inert Ingredients in Pesticide 

Formulations’’ in docket ID number 

EPA–HQ–OPP–2012–0043. 

B. Toxicological Points of Departure/

Levels of Concern 

The available toxicity studies indicate 

that trans-1,3,3,3-tetrafluoroprop-1-ene 

has very low overall toxicity. The lowest 

NOAEL in the database was 5,000 ppm 

(approximately 7,800 mg/kg/day human 

equivalent dose) observed in a 13 week 

toxicity study in rats via the inhalation 

route of exposure. Since signs of toxicity 

were not observed at well above the 

limit dose an endpoint of concern for 

risk assessment purposes was not 

identified. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to trans-1,3,3,3- 

tetrafluoroprop-1-ene, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. 

EPA assessed dietary exposures from 

trans-1,3,3,3-tetrafluoroprop-1-ene in 

food as follows: 


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The general population may be 

exposed via the diet to trans-1,3,3,3- 

tetrafluoroprop-1-ene as a result of 

eating foods containing residues of 

trans-1,3,3,3-tetrafluoroprop-1-ene. 

However, since a hazard endpoint of 

concern was not identified for the acute 

and chronic dietary assessment (food 

and drinking water), a dietary exposure 

risk assessment was not conducted. 

2. 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). 

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). Trans-1,3,3,3-tetrafluoroprop-1- 

ene may be used as an inert ingredient 

in pesticide products that could result 

in short- and intermediate-term 

residential exposure. However, based on 

the lack of toxicity, a quantitative 

exposure assessment from residential 

exposures was not performed. 

3. 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 trans-1,3,3,3- 

tetrafluoroprop-1-ene to share a 

common mechanism of toxicity with 

any other substances, and trans-1,3,3,3- 

tetrafluoroprop-1-ene does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that trans-1,3,3,3- 

tetrafluoroprop-1-ene 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 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) margin of safety 

for infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. Based on the lack 

of effects in subchronic and 

developmental toxicity studies, and an 

assessment of trans-1,3,3,3- 

tetrafluoroprop-1-ene, EPA has 

concluded that there are no 

toxicological endpoints of concern for 

the U.S. population, including infants 

and children. 

E. Aggregate Risks and Determination of 

Safety 

Because no toxicological endpoints of 

concern were identified, EPA concludes 

that aggregate exposure to residues of 

trans-1,3,3,3-tetrafluoroprop-1-ene will 

not pose a risk to the U.S. population, 

including infants and children, and that 

there is a reasonable certainty that no 

harm will result to the general 

population, or to infants and children 

from aggregate exposure to trans-1,3,3,3- 

tetrafluoroprop-1-ene 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. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910, 180.930 and 

180.940(a) for trans-1,3,3,3- 

tetrafluoroprop-1-ene (CAS Reg. No. 

29118–24–9) when used as an inert 

ingredient (propellant) in pesticide 

formulations applied to formulations 

applied to growing crops, raw 

agricultural commodities after harvest, 

and animals, and when used as an inert 

ingredient in antimicrobial pesticide 

formulations for food-contact surface 

sanitizing solutions, respectively. 

VII. Statutory and Executive Order 

Reviews 

This action establishes exemptions 

from the requirement of a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 


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61122 Federal Register / Vol. 80, No. 196 / Friday, October 9, 2015 / Rules and Regulations 

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: October 1, 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 § 180.910, add alphabetically the 

inert ingredient 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 

*******

Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) ....................................................... .............................. Propellant. 

* * * * * * * 

■ 3. In § 180.930 add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

Inert ingredients Limits Uses 

*******

Trans-1,3,3,3-tetrafluoroprop-1-ene (CAS Reg. No. 29118–24–9) ....................................................... .............................. Propellant. 

* * * * * * * 

■ 4. In § 180.940(a), add alphabetically 

the inert ingredient to the table to read 

as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solution). 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Trans-1,3,3,3-tetrafluoroprop-1-ene ....................................................................................................... 29118–24–9 None. 

* * * * * * * 

* * * * * 

[FR Doc. 2015–25690 Filed 10–8–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0482; FRL–9934–45] 

Cellulose Carboxymethyl Ether, 

Potassium Salt; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of cellulose 

carboxymethyl ether, potassium salt; 

when used as an inert ingredient in a 

pesticide chemical formulation. Spring 

Trading Company on behalf of Lamberti 

USA, Incorporated submitted a petition 

to EPA under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), requesting 

an exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 


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