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[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Rules and Regulations]
[Pages 20535-20540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08152]

[[Page 20535]]

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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.

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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

[[Page 20536]]

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 first-time 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 E-payment 
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

[[Page 20537]]

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

[[Page 20538]]

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

[[Page 20539]]

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,

[[Page 20540]]

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]

0
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.

0
2. In Sec.  9.1, add the following section in numerical order under the 
undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB Control
                     40 CFR citation                          number
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
 
                                * * * * *
721.10851...............................................       2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

0
4. Add Sec.  721.10851 to subpart E to read as follows:

Sec.  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
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