Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 20535 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2014–0697; FRL–9943–83] 

RIN 2070–AK05 

Trichloroethylene; Significant New Use 

Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: Under the Toxic Substance 

Control Act (TSCA), EPA is finalizing a 

significant new use rule (SNUR) for 

trichloroethylene (TCE). The significant 

new use is the manufacture or 

processing for use in a consumer 

product, with an exception for use of 

TCE in cleaners and solvent degreasers, 

film cleaners, hoof polishes, lubricants, 

mirror edge sealants, and pepper spray. 

Persons subject to the SNUR will be 

required to notify EPA at least 90 days 

before commencing any manufacturing 

or processing of TCE for a significant 

new use. The required notification will 

provide EPA with the opportunity to 

evaluate the intended use and, if 

necessary based on the information 

available at that time, an opportunity to 

protect against potential unreasonable 

risks, if any, from that activity before it 

occurs. 

DATES: This final rule is effective 

June 7, 2016. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2014–0697, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, 

DC. 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 OPPT 

Docket is (202) 566–0280. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Tyler 

Lloyd, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–4016; email address: 

lloyd.tyler@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture, process, 

or distribute in commerce chemical 

substances and mixtures. 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: 

• Textile Product Mills (NAICS code 

314). 

• Wood Product Manufacturing 

(NAICS code 321). 

• Printing and Related Support 

Activities (NAICS code 323). 

• Chemical Manufacturing (NAICS 

code 325). 

• Plastics and Rubber Product 

Manufacturing (NAICS code 326). 

• Primary Metal Manufacturing 

(NAICS code 331). 

• Fabricated Metal Product 

Manufacturing (NAICS code 332). 

• Machinery Manufacturing (NAICS 

code 333). 

• Computer and Electronic Product 

Manufacturing (NAICS code 334). 

• Electrical Equipment, Appliance, 

and Component Manufacturing (NAICS 

code 335). 

• Transportation Equipment 

Manufacturing (NAICS code 336). 

• Furniture and Product Related 

Manufacturing (NAICS code 337). 

• Miscellaneous Manufacturing 

(NAICS code 339). 

• Clothing and Clothing Accessory 

Stores (NAICS code 488). 

• Warehousing and Storage (NAICS 

code 493). 

• Repair and Maintenance (NAICS 

code 811). 

• National Security and International 

Affairs (NAICS code 928). 

Other types of entities not listed in 

this unit could also be affected. The 

NAICS codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. 

This action may also affect certain 

entities through pre-existing import 

certification and export notification 

rules under TSCA. Persons who import 

any chemical substance governed by a 

final SNUR are subject to the TSCA 

section 13 (15 U.S.C. 2612) import 

certification requirements and the 

corresponding regulations at 19 CFR 

12.118 through 12.127; see also 19 CFR 

127.28. Those persons must certify that 

the shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. In 

addition, any persons who export or 

intend to export a chemical substance 

that is the subject of this final rule are 

subject to the export notification 

provisions of TSCA section 12(b) (15 

U.S.C. 2611(b)), (see 40 CFR 721.20), 

and must comply with the export 

notification requirements in 40 CFR part 

707, subpart D. 

To determine whether you or your 

business may be affected by this action, 

you should carefully examine the 

applicability provisions in 40 CFR 

721.5. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the 

technical information contact listed 

under FOR FURTHER INFORMATION

CONTACT. 

B. What is the agency’s authority for 

taking this action? 

Section 5(a)(2) of TSCA (15 U.S.C. 

2604(a)(2)) authorizes EPA to determine 

that a use of a chemical substance is a 

‘‘significant new use.’’ EPA must make 

this determination by rule after 

considering all relevant factors, 

including those listed in TSCA section 

5(a)(2). Once EPA determines that a use 

of a chemical substance is a significant 

new use, TSCA section 5(a)(1)(B) 

requires persons to submit a significant 

new use notice (SNUN) to EPA at least 

90 days before they manufacture 

(including import) or process the 

chemical substance for that use (15 

U.S.C. 2604(a)(1)(B)). As described in 

Unit V., the general SNUR provisions 

are found at 40 CFR part 721, subpart 

A. 

C. What action is the agency taking? 

This final SNUR will require persons 

to notify EPA at least 90 days before 

commencing the manufacture 

(including import) or processing of TCE 

for use in a consumer product except for 

use in cleaners and solvent degreasers, 

film cleaners, hoof polishes, lubricants, 

mirror edge sealants, and pepper spray. 

The SNUR was proposed in the 

Federal Register of August 7, 2015 (80 

FR 47441) (FRL–9930–33) (Ref. 1). 

Please consult the August 7, 2015 

Federal Register document for further 

background information for this final 

rule. Additionally, please note that the 


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RIN for the proposed SNUR was 

inadvertently published as RIN 2070– 

AK50. This final SNUR bears the correct 

identification, RIN 2070–AK05. EPA 

received 4 public comments on the 

proposal and EPA’s response to those 

comments appear in Unit X. 

D. Why is the agency taking this action? 

This SNUR is necessary to ensure that 

EPA receives timely advance notice of 

any future manufacturing and 

processing of TCE for new uses that may 

produce changes in human and 

environmental exposures. The rationale 

and objectives for this SNUR are 

explained in Unit III. 

E. What are the estimated incremental 

impacts of this action? 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of TCE. 

This analysis (Ref. 2), which is available 

in the docket, is discussed in Unit IX., 

and is briefly summarized here. 

In the event that a SNUN is 

submitted, costs are estimated to be less 

than $8,900 per SNUN submission for 

large business submitters and $6,500 for 

small business submitters. These 

estimates include the cost to prepare 

and submit the SNUN and the payment 

of a user fee. The SNUR requires firsttime submitters of any TSCA section 5 

notice to register their company and key 

users with the CDX reporting tool, 

deliver a CDX electronic signature to 

EPA, and establish and use a Pay.gov Epayment account before they may 

submit a SNUN, for a cost of 

approximately $200 per firm. However, 

these activities are only required of first 

time submitters of section 5 notices. In 

addition, for persons exporting a 

substance that is the subject of a SNUR, 

a one-time notice to EPA must be 

provided for the first export or intended 

export to a particular country, which is 

estimated to be approximately $80 per 

notification. 

II. Chemical Substance Subject to This 

Rule 

This final SNUR applies to TCE 

(Chemical Abstract Services Registry 

Number (CASRN) 79–01–6) 

manufactured (including import) or 

processed for use in any consumer 

product, except for use in cleaners and 

solvent degreasers, film cleaners, hoof 

polishes, lubricants, mirror edge 

sealants, and pepper spray. A consumer 

product is defined at 40 CFR 721.3 as ‘‘a 

chemical substance that is directly, or as 

part of a mixture, sold or made available 

to consumers for their use in or around 

a permanent or temporary household or 

residence, in or around a school, or in 

recreation.’’ 

III. Rationale and Objectives 

A. Rationale 

As discussed in detail in Units II and 

III of the proposed rule (80 FR 47441; 

August 7, 2015), TCE has the potential 

to induce neurotoxicity, 

immunotoxicity, developmental 

toxicity, liver toxicity, kidney toxicity, 

endocrine effects, and several forms of 

cancer (Ref. 3). EPA is concerned about 

the adverse health effects of TCE 

resulting from commercial and 

consumer uses of the chemical 

substance. In EPA’s final risk 

assessment of TCE, released on June 25, 

2014, the Agency identified risks to 

workers using TCE and to bystanders for 

use as degreasers and a spot-cleaner in 

dry cleaning uses, and EPA also 

identified health risks to consumers 

using spray aerosol degreasers and spray 

fixatives (Ref. 3). 

EPA believes that any additional use 

of this chemical substance in consumer 

products could significantly increase 

human exposure, and that such 

exposures should not occur without an 

opportunity for EPA review and control 

as appropriate. However, as discussed 

in Unit II of the proposed rule (80 FR 

47441; August 7, 2015), based on review 

of Safety Data Sheets and the National 

Institutes of Health’s Household 

Products Database, EPA believes that 

cleaners and solvent degreasers, film 

cleaners, hoof polishes, lubricants, 

mirror edge sealants, and pepper spray 

presently contain TCE and are therefore 

ongoing uses of this chemical. EPA 

believes that other consumer products 

do not presently contain TCE. Spray 

fixative product use was discontinued 

by September 1, 2015, as described in 

Unit II.A of the proposed rule (80 FR 

47441). 

Consistent with EPA’s past practice 

for issuing SNURs under TSCA section 

5(a)(2), EPA’s decision to promulgate a 

SNUR for a particular chemical use 

need not be based on an extensive 

evaluation of the hazard, exposure, or 

potential risk associated with that use. 

Rather, the Agency action is based on 

EPA’s determination that if the use 

begins or resumes, it may present a risk 

that EPA should evaluate under TSCA 

before the manufacturing or processing 

for that use begins. Since the new use 

does not currently exist, deferring a 

detailed consideration of potential risks 

or hazards related to that use is an 

effective use of resources. If a person 

decides to begin manufacturing or 

processing the chemical for the use, the 

notice to EPA allows EPA to evaluate 

the use according to the specific 

parameters and circumstances 

surrounding that intended use. 

B. Objectives 

Based on the considerations in Unit 

III.A., EPA will achieve the following 

objectives with regard to the significant 

new use(s) that are designated in this 

final rule: 

1. EPA will receive notice of any 

person’s intent to manufacture or 

process TCE for the described 

significant new use before that activity 

begins. 

2. EPA will have an opportunity to 

review and evaluate data submitted in a 

SNUN before the notice submitter 

begins manufacturing or processing TCE 

for the described significant new use. 

3. EPA will be able to regulate 

prospective manufacturers or processors 

of TCE before the described significant 

new use of the chemical substance 

occurs, provided that regulation is 

warranted pursuant to TSCA section 

5(e), 5(f), 6, or 7. 

IV. Significant New Use Determination 

Section 5(a)(2) of TSCA states that 

EPA’s determination that a use of a 

chemical substance is a significant new 

use must be made after consideration of 

all relevant factors including: 

1. The projected volume of 

manufacturing and processing of a 

chemical substance. 

2. The extent to which a use changes 

the type or form of exposure of human 

beings or the environment to a chemical 

substance. 

3. The extent to which a use increases 

the magnitude and duration of exposure 

of human beings or the environment to 

a chemical substance. 

4. The reasonably anticipated manner 

and methods of manufacturing, 

processing, distribution in commerce, 

and disposal of a chemical substance. 

In addition to these factors 

enumerated in TSCA section 5(a)(2), the 

statute authorizes EPA to consider any 

other relevant factors. 

To determine what would constitute a 

significant new use of TCE, as discussed 

in Unit II of the proposed rule (80 FR 

47441), EPA considered relevant 

information about the toxicity of the 

substance, likely human exposures and 

environmental releases associated with 

possible uses, and the four factors listed 

in section 5(a)(2) of TSCA (80 FR 

47441). EPA has determined as the 

significant new use: Manufacture or 

processing for any use in a consumer 

product, except for use in cleaners and 

solvent degreasers, film cleaners, hoof 

polishes, lubricants, mirror edge 

sealants, and pepper spray. Because 


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TCE is not used in consumer products 

(with the limited exceptions of use in 

cleaners and solvent degreasers, film 

cleaners, hoof polishes, lubricants, 

mirror edge sealants, and pepper spray), 

EPA believes new use in consumer 

products could increase the magnitude 

and duration of human exposure to 

TCE. Exposure to TCE through 

inhalation may lead to a wide array of 

adverse health effects, such as 

neurotoxicity, immunotoxicity, 

developmental toxicity, liver toxicity, 

kidney toxicity, endocrine effects, and 

several forms of cancer, as further 

explained in Unit II.C of the proposed 

rule (80 FR 47441), and because of these 

potential adverse effects EPA would like 

the opportunity to evaluate such 

potential uses in consumer products for 

any associated risks or hazards that 

might exist before those uses would 

begin. 

V. Applicability of the General 

Provisions 

General provisions for SNURs appear 

under 40 CFR part 721, subpart A. 

These provisions describe persons 

subject to the rule, recordkeeping 

requirements, exemptions to reporting 

requirements, and applicability of the 

rule to uses occurring before the 

effective date of the final rule. 

Provisions relating to user fees appear 

at 40 CFR part 700. According to 40 CFR 

721.1(c), persons subject to SNURs must 

comply with the same notice 

requirements and EPA regulatory 

procedures as submitters of 

Premanufacture Notices (PMNs) under 

TSCA section 5(a)(1)(A). In particular, 

these requirements include the 

information submissions requirements 

of TSCA section 5(b) and 5(d)(1), the 

exemptions authorized by TSCA section 

5(h)(1), (h)(2), (h)(3), and (h)(5), and the 

regulations at 40 CFR part 720. Once 

EPA receives a SNUN, EPA may take 

regulatory action under TSCA section 

5(e), 5(f), 6, or 7 to control the activities 

on which it has received the SNUN. If 

EPA does not take action, EPA is 

required under TSCA section 5(g) to 

explain in the Federal Register its 

reasons for not taking action. 

Persons who export or intend to 

export a chemical substance identified 

in a proposed or final SNUR are subject 

to the export notification provisions of 

TSCA section 12(b). The regulations that 

interpret TSCA section 12(b) appear at 

40 CFR part 707, subpart D. In 

accordance with 40 CFR 707.60(b), this 

final SNUR does not trigger export 

notification for articles. Persons who 

import a chemical substance identified 

in a final SNUR are subject to the TSCA 

section 13 import certification 

requirements, codified at 19 CFR 12.118 

through 12.127; see also 19 CFR 127.28. 

Those persons must certify that the 

shipment of the chemical substance 

complies with all applicable rules and 

orders under TSCA, including any 

SNUR requirements. The EPA policy in 

support of import certification appears 

at 40 CFR part 707, subpart B. 

VI. Applicability of Rule to Uses 

Occurring Before Effective Date of the 

Final Rule 

As discussed in the Federal Register 

of April 24, 1990 (55 FR 17376; FRL– 

3658–5) (Ref. 4), EPA has decided that 

the intent of section 5(a)(1)(B) of TSCA 

is best served by designating a use as a 

significant new use as of the date of 

publication of the proposed rule rather 

than as of the effective date of the final 

rule. If uses begun after publication of 

the proposed rule were considered 

ongoing rather than new, it would be 

difficult for EPA to establish SNUR 

notice requirements, because a person 

could defeat the SNUR by initiating the 

proposed significant new use before the 

rule became final, and then argue that 

the use was ongoing as of the effective 

date of the final rule. Thus, persons who 

begin commercial manufacture or 

processing of TCE after the proposal was 

published on August 7, 2015, must 

cease such activity before the effective 

date of this final rule. To resume their 

activities, these persons would have to 

comply with all applicable SNUR notice 

requirements and wait until the notice 

review period, including all extensions, 

expires. Uses arising after the 

publication of the proposed rule are 

distinguished from uses that exist at 

publication of the proposed rule. The 

former would be new uses, the latter 

ongoing uses, except that uses that are 

ongoing as of the publication of the 

proposed rule would not be considered 

ongoing uses if they have ceased by the 

date of issuance of a final rule. 

However, recognizing that use in a 

consumer product of TCE in spray 

fixatives was to cease and did cease by 

September 1, 2015 as described in Unit 

II.A. of the proposed rule (80 FR 47441), 

EPA considers September 1, 2015 as the 

date from which the significant new use 

with respect only to such spray fixatives 

would be designated. Public 

commenters on the proposed rule did 

not identify any additional ongoing 

uses. EPA has promulgated provisions 

to allow persons to comply with this 

SNUR before the effective date. If a 

person were to meet the conditions of 

advance compliance under 40 CFR 

721.45(h), that person would be 

considered to have met the 

requirements of the final SNUR for 

those activities. 

VII. Test Data and Other Information 

EPA recognizes that TSCA section 5 

does not usually require developing any 

particular test data before submission of 

a SNUN. There are two exceptions: 

1. Development of test data is 

required where the chemical substance 

subject to the SNUR is also subject to a 

test rule under TSCA section 4 (see 

TSCA section 5(b)(1)); and 

2. Development of test data may be 

necessary where the chemical substance 

has been listed under TSCA section 

5(b)(4) (see TSCA section 5(b)(2)). 

In the absence of a section 4 test rule 

or a section 5(b)(4) listing covering the 

chemical substance, persons are 

required to submit only test data in their 

possession or control and to describe 

any other data known to or reasonably 

ascertainable by them (15 U.S.C. 

2604(d); 40 CFR 721.25, and 40 CFR 

720.50). However, as a general matter, 

EPA recommends that SNUN submitters 

include data that would permit a 

reasoned evaluation of risks posed by 

the chemical substance during its 

manufacture, processing, use, 

distribution in commerce, or disposal. 

EPA encourages persons to consult with 

the Agency before submitting a SNUN. 

As part of this optional pre-notice 

consultation, EPA would discuss 

specific data it believes may be useful 

in evaluating a significant new use. 

SNUNs submitted for significant new 

uses without any test data may increase 

the likelihood that EPA will take action 

under TSCA section 5(e) to prohibit or 

limit activities associated with this 

chemical. 

SNUN submitters should be aware 

that EPA will be better able to evaluate 

SNUNs that provide detailed 

information on: 

• Human exposure and 

environmental releases that may result 

from the significant new uses of the 

chemical substance; 

• Potential benefits of the chemical 

substance; and 

• Information on risks posed by the 

chemical substances compared to risks 

posed by potential substitutes. 

VIII. SNUN Submissions 

EPA recommends that submitters 

consult with the Agency prior to 

submitting a SNUN to discuss what data 

may be useful in evaluating a significant 

new use. Discussions with the Agency 

prior to submission can afford ample 

time to conduct any tests that might be 

helpful in evaluating risks posed by the 

substance. According to 40 CFR 

721.1(c), persons submitting a SNUN 


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must comply with the same notice 

requirements and EPA regulatory 

procedures as persons submitting a 

PMN, including submission of test data 

on health and environmental effects as 

described in 40 CFR 720.50. SNUNs 

must be submitted on EPA Form No. 

7710–25, generated using e-PMN 

software, and submitted to the Agency 

in accordance with the procedures set 

forth in 40 CFR 721.25 and 40 CFR 

720.40. E–PMN software is available 

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

opptintr/newchems. 

IX. Economic Analysis 

A. SNUNs 

EPA has evaluated the potential costs 

of establishing SNUR reporting 

requirements for potential 

manufacturers and processors of the 

chemical substance included in this 

final rule (Ref. 2). In the event that a 

SNUN is submitted, costs are estimated 

at approximately $8,900 per SNUN 

submission for large business submitters 

and $6,500 for small business 

submitters. These estimates include the 

cost to prepare and submit the SNUN, 

and the payment of a user fee. 

Businesses that submit a SNUN would 

be subject to either a $2,500 user fee 

required by 40 CFR 700.45(b)(2)(iii), or, 

if they are a small business with annual 

sales of less than $40 million when 

combined with those of the parent 

company (if any), a reduced user fee of 

$100 (40 CFR 700.45(b)(1)). EPA’s 

complete economic analysis is available 

in the public docket for this final rule 

(Ref. 2). 

B. Export Notification 

Under section 12(b) of TSCA and the 

implementing regulations at 40 CFR part 

707, subpart D, exporters must notify 

EPA if they export or intend to export 

a chemical substance or mixture for 

which, among other things, a rule has 

been proposed or promulgated under 

TSCA section 5. For persons exporting 

a substance that is the subject of a 

SNUR, a one-time notice to EPA must be 

provided for the first export or intended 

export to a particular country. The total 

costs of export notification will vary by 

chemical, depending on the number of 

required notifications (i.e., the number 

of countries to which the chemical is 

exported). While EPA is unable to make 

any estimate of the likely number of 

export notifications for the chemical 

covered in this final SNUR, as stated in 

the accompanying economic analysis of 

this final SNUR, the estimated cost of 

the export notification requirement on a 

per unit basis is approximately $80. 

X. Response to Public Comment 

The Agency reviewed and considered 

all comments received related to the 

proposed rule. Copies of all comments 

are available in the docket for this 

action (EPA–HQ–OPPT–2014–0697). A 

discussion of the major comments 

germane to the rulemaking and the 

Agency’s responses follow. 

A. Support for TCE SNUR 

1. Comment. One commenter 

supports the proposed rule and 

reiterates human health effects related 

to TCE exposure. (Docket ID# EPA–HQ– 

OPPT–2014–0697–0009.) 

Response. EPA acknowledges the 

comment. 

2. Comment. One commenter 

supports the proposed rule and asks 

EPA to (a) ‘‘broaden the scope of the 

SNUR to: (1) Include certain commercial 

uses of TCE, and (2) regularly review 

ongoing uses of TCE and update the 

SNUR to include any discontinued 

uses’’ and (b) ‘‘promptly promulgate a 

TSCA section 6(a) rule to address 

identified risks of TCE from ongoing 

uses.’’ (Docket ID# EPA–HQ–OPPT– 

2014–0697–0010.) 

Response. The commenter points out 

that there are ‘‘widespread ongoing 

commercial uses of TCE.’’ Currently 

ongoing commercial uses of TCE cannot 

be included in the SNUR. EPA will 

continue to monitor uses of TCE and 

consider promulgating future SNURs for 

discontinued or other non-ongoing uses. 

TSCA section 6 provides authority for 

EPA to ban or restrict the manufacture 

(including import), processing, 

distribution in commerce, and use of 

chemicals, as well as any manner or 

method of disposal. EPA identified TCE 

for risk evaluation as part of its Work 

Plan for Chemical Assessment under 

TSCA. TCE is used in industrial and 

commercial processes, and also has 

some limited uses in consumer 

products. In the June 2014 TSCA Work 

Plan Chemical Risk Assessment, EPA 

identified risks associated with 

commercial degreasing and some 

consumer uses. EPA is initiating 

rulemaking under TSCA section 6 to 

address these risks. Specifically, EPA 

will determine whether the use of TCE 

in some commercial degreasing uses, as 

a spotting agent in dry cleaning, and in 

certain consumer products presents an 

unreasonable risk to human health and 

the environment such that regulation is 

warranted under TSCA section 6. 

3. Comment. One commenter agrees 

with the EPA’s understanding that TCE 

is not widely used, with the exception 

of TCE in cleaners and solvent, 

degreasers, film cleaners, hoof polishes, 

lubricants, mirror edge sealants, and 

pepper spray. (Docket ID# EPA–HQ– 

OPPT–2014–0697–0011.) 

Response. EPA acknowledges the 

comment. 

4. Comment. One commenter asks the 

Agency to ‘‘rescind any exemption to 

issuing a notice to any party looking to 

begin using TCE in the production of 

any consumer good’’ because TCE ‘‘is 

known to be a volatile organic 

compound (VOC) with a close 

association with many adverse health 

and environmental effects.’’ (Docket ID# 

EPA–HQ–OPPT–2014–0697–0008.) 

Response. EPA acknowledges the 

comment. As described in Unit III.A., by 

issuing this final rule EPA defers, if and 

until such time as a SNUN is submitted, 

the opportunity to evaluate the use 

according to the specific parameters and 

circumstances surrounding that 

intended use before such use could 

occur. In the event that a SNUN is 

submitted, EPA will follow all 

regulations and guidelines, pursuant to 

TSCA section 5(a)(2), that guide the 

assessment of any environmental and 

health concerns resulting from the 

Significant New Use. 

B. Review of Work Plan Chemical Risk 

Assessment 

1. Comment. One commenter 

contends that the final Work Plan 

Chemical Risk Assessment ‘‘should not 

serve as the basis for regulation’’ and 

notes specific concerns with it, asking 

EPA to respond to each. (Docket ID# 

EPA–HQ–OPPT–2014–0697–0011.) 

Response. The peer-reviewed Work 

Plan Chemical Risk Assessment 

referenced by the commenter includes 

an assessment of the hazard of TCE. As 

described in the risk assessment, TCE is 

carcinogenic to humans and TCE 

exposure is associated with a range of 

non-cancer health effects in humans and 

animals, including developmental 

toxicity, immunotoxicity, kidney 

toxicity, reproductive toxicity, 

neurotoxicity and liver toxicity. While 

EPA considered relevant information 

about the toxicity of the substance, 

likely human exposures and 

environmental releases associated with 

possible uses, and the four factors listed 

in section 5(a)(2) of TSCA (80 FR 

47441), EPA believes that the 

commenter’s specific concerns are not 

relevant to the ‘‘basis for regulation’’ for 

this SNUR. 

Under section 5(a)(2), EPA is neither 

required to determine that a particular 

new use of any chemical substances 

presents, nor even that it may present, 

an unreasonable risk to human health or 

the environment. Rather, EPA issues a 

SNUR for a particular new use of a 


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substance if it has reason to anticipate 

that the use would raise significant 

questions related to potential exposure, 

so that it should have an opportunity to 

review the use before such use should 

occur. As discussed in Unit IV, EPA 

based this judgement on a consideration 

of all relevant factors, including the 

specific factors identified at section 

5(a)(2). 

XI. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

1. EPA. Trichloroethylene (TCE); 

Significant New Use Rule; TCE in Certain 

Consumer Products; Proposed Rule. Federal 

Register (80 FR 47441, August 7, 2015) (FRL– 

9930–33). 

2. EPA. Economic Analysis for the Final 

Significant New Use Rule for 

Trichloroethylene (TCE). March 10, 2016. 

3. EPA. TSCA Workplan Chemical Risk 

Assessment—Trichloroethylene: Degreasing, 

Spot Cleaning and Arts & Crafts Uses; 

Supporting and Related Material. June 25, 

2014. 

4. EPA. Significant New Uses of Certain 

Chemical Substances; Final Rule. Federal 

Register (55 FR 17376, April 24, 1990) (FRL– 

3658–5). 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is not a significant 

regulatory action and was therefore not 

submitted to the Office of Management 

and Budget (OMB) for review under 

Executive Orders 12866 (58 FR 51735, 

October 4, 1993) and 13563 (76 FR 3821, 

January 21, 2011). 

B. Paperwork Reduction Act (PRA) 

This action does not impose any new 

information collection burden under the 

PRA, 44 U.S.C. 3501 et seq. Burden is 

defined in 5 CFR 1320.3(b). The 

information collection activities 

associated with existing chemical 

SNURs are already approved by OMB 

under OMB control number 2070–0038 

(EPA ICR No. 1188); and the 

information collection activities 

associated with export notifications are 

already approved by OMB under OMB 

control number 2070–0030 (EPA ICR 

No. 0795). If an entity were to submit a 

SNUN to the Agency, the annual burden 

is estimated to be less than 100 hours 

per response, and the estimated burden 

for export notifications is less than 1.5 

hours per notification. In both cases, 

burden is estimated to be reduced for 

submitters who have already registered 

to use the electronic submission system. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

that requires OMB approval under the 

PRA, unless it has been approved by 

OMB and displays a currently valid 

OMB control number. The OMB control 

numbers for EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and included on the related 

collection instrument, or form, if 

applicable. EPA is amending the table in 

40 CFR part 9 to list this SNUR. This 

listing of the OMB control numbers and 

their subsequent codification in the CFR 

satisfies the display requirements of the 

PRA and OMB’s implementing 

regulations at 5 CFR part 1320. Since 

the existing OMB approval was 

previously subject to public notice and 

comment before OMB approval, and 

given the technical nature of the table, 

EPA finds that further notice and 

comment to amend the table is 

unnecessary. As a result, EPA finds that 

there is ‘‘good cause’’ under section 

553(b)(3)(B) of the Administrative 

Procedure Act, 5 U.S.C. 553(b)(3)(B), to 

amend this table without further notice 

and comment. 

C. Regulatory Flexibility Act (RFA) 

Pursuant to section 605(b) of the RFA, 

5 U.S.C. 601 et seq., I certify that this 

action will not have a significant 

economic impact on a substantial 

number of small entities. 

A SNUR applies to any person 

(including small or large entities) who 

intends to engage in any activity 

described in the rule as a ‘‘significant 

new use.’’ By definition of the word 

‘‘new’’ and based on all information 

currently available to EPA, it appears 

that no small or large entities presently 

engage in such activities. Since this 

SNUR will require a person who intends 

to engage in such activity in the future 

to first notify EPA by submitting a 

SNUN, no economic impact will occur 

unless someone files a SNUN to pursue 

a significant new use in the future or 

forgoes profits by avoiding or delaying 

the significant new use. Although some 

small entities may decide to conduct 

such activities in the future, EPA cannot 

presently determine how many, if any, 

there may be. However, EPA’s 

experience to date is that, in response to 

the promulgation of SNURs covering 

over 1,000 chemical substances, the 

Agency receives only a handful of 

notices per year. During the six year 

period from 2005–2010, only three 

submitters self-identified as small in 

their SNUN submission (Ref. 2). EPA 

believes the cost of submitting a SNUN 

is relatively small compared to the cost 

of developing and marketing a chemical 

new to a firm or marketing a new use 

of the chemical and that the 

requirement to submit a SNUN 

generally does not have a significant 

economic impact. 

Therefore, EPA believes that the 

potential economic impact of complying 

with this final SNUR is not expected to 

be significant or adversely impact a 

substantial number of small entities. In 

a SNUR that published as a final rule on 

August 8, 1997 (62 FR 42690) (FRL– 

5735–4), the Agency presented its 

general determination that proposed 

and final SNURs are not expected to 

have a significant economic impact on 

a substantial number of small entities. 

D. Unfunded Mandates Reform Act 

(UMRA) 

Based on EPA’s experience with 

proposing and finalizing SNURs, State, 

local, and Tribal governments have not 

been impacted by these rulemakings, 

and EPA does not have any reason to 

believe that any State, local, or Tribal 

government would be impacted by this 

rulemaking. As such, the requirements 

of sections 202, 203, 204, or 205 of 

UMRA, 2 U.S.C. 1531–1538, do not 

apply to this action. 

E. Executive Order 13132: Federalism 

This action will not have a substantial 

direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This final rule does not have Tribal 

implications because it is not expected 

to have any effect (i.e., there will be no 

increase or decrease in authority or 

jurisdiction) on Tribal governments, on 

the relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes. Thus, 

Executive Order 13175 (65 FR 67249, 


asabaliauskas on DSK3SPTVN1PROD with RULES
20540 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 

November 9, 2000) does not apply to 

this action. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets Executive Order 13045 

(62 FR 19885, April 23, 1997), as 

applying only to those regulatory 

actions that concern environmental 

health or safety risks that EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. This action is not 

subject to Executive Order 13045 

because it does not concern an 

environmental health risk or safety risk. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This final rule is not subject to 

Executive Order 13211 (66 FR 28355, 

May 22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

Since this action does not involve any 

technical standards, section 12(d) of 

NTTAA, 15 U.S.C. 272 note, does not 

apply to this action. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

This final rule does not invoke special 

consideration of environmental justice 

related issues as delineated by 

Executive Order 12898 (59 FR 7629, 

February 16, 1994), because EPA has 

determined that this action will not 

have disproportionately high and 

adverse human health or environmental 

effects on minority or low-income 

populations. This action does not affect 

the level of protection provided to 

human health or the environment. 

XIII. Congressional Review Act (CRA) 

This action is subject to the CRA, 5 

U.S.C. 801 et seq., and the EPA will 

submit a rule report to each House of 

Congress and the Comptroller of the 

United States. This action is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects 

40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

40 CFR Part 721 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: April 4, 2016. 

Wendy Cleland-Hamnett, 

Director, Office of Pollution Prevention and 

Toxics. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 9—[AMENDED] 

■ 1. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ 2. In § 9.1, add the following section 

in numerical order under the 

undesignated center heading 

‘‘Significant New Uses of Chemical 

Substances’’ to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 

40 CFR citation OMB Control 

number 

* * * * * 

Significant New Uses of Chemical 

Substances 

* * * * * 

721.10851 ............................. 2070–0038 

* * * * * 

* * * * * 

PART 721—[AMENDED] 

■ 3. The authority citation for part 721 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 

2625(c). 

■ 4. Add § 721.10851 to subpart E to 

read as follows: 

§ 721.10851 Trichloroethylene. 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance 

trichloroethylene (CAS 79–01–6) is 

subject to reporting under this section 

for the significant new use described in 

paragraph (a)(2) of this section. 

(2) Manufacture or processing for use 

in a consumer product except for use in 

cleaners and solvent degreasers, film 

cleaners, hoof polishes, lubricants, 

mirror edge sealants, and pepper spray. 

(b) [Reserved] 

[FR Doc. 2016–08152 Filed 4–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2015–0773; FRL–9944–73– 

Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Pennsylvania; Attainment Plan and 

Base Year Inventory for the North 

Reading Area for the 2008 Lead 

National Ambient Air Quality 

Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving a state 

implementation plan (SIP) revision 

submitted by the Commonwealth of 

Pennsylvania (Pennsylvania). The 

revision demonstrates attainment of the 

2008 lead national ambient air quality 

standards (NAAQS) in the North 

Reading 2008 lead nonattainment area 

(North Reading Area or Area). The 

attainment plan includes the base year 

emissions inventory, an analysis of 

reasonably available control technology 

(RACT), reasonably available control 

measures (RACM), and reasonable 

further progress (RFP), modeling 

demonstration of lead attainment, and 

contingency measures for the Area. EPA 

is approving Pennsylvania’s lead 

attainment plan with the base year 

emissions inventory for the North 

Reading Area as a revision to 

Pennsylvania’s SIP in accordance with 

the requirements of the Clean Air Act 

(CAA). 

DATES: This final rule is effective on 

May 9, 2016. 

ADDRESSES: EPA has established a 

docket for this action under Docket ID 

Number EPA–R03–OAR–2015–0773. All 

documents in the docket are listed in 

the www.regulations.gov Web site. 

Although listed in the electronic docket, 

some information is not publicly 

available, i.e., confidential business 

information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 


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