Federal Register /Vol. 81, No. 68/Friday, April 8, 2016 ...

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

asabaliauskas on DSK3SPTVN1PROD with RULES ENVIRONMENTAL PROTECTION For general information contact: The section 13 (15 U.S.C. 2612) import
AGENCY TSCA-Hotline, ABVI-Goodwill, 422 certification requirements and the
South Clinton Ave., Rochester, NY corresponding regulations at 19 CFR
40 CFR Parts 9 and 721 14620; telephone number: (202) 554– 12.118 through 12.127; see also 19 CFR
1404; email address: TSCA-Hotline@ 127.28. Those persons must certify that
[EPA–HQ–OPPT–2014–0697; FRL–9943–83] epa.gov. the shipment of the chemical substance
complies with all applicable rules and
RIN 2070–AK05 SUPPLEMENTARY INFORMATION: orders under TSCA, including any
SNUR requirements. The EPA policy in
Trichloroethylene; Significant New Use I. Executive Summary support of import certification appears
Rule at 40 CFR part 707, subpart B. In
A. Does this action apply to me? addition, any persons who export or
AGENCY: Environmental Protection intend to export a chemical substance
Agency (EPA). You may be potentially affected by that is the subject of this final rule are
this action if you manufacture, process, subject to the export notification
ACTION: Final rule. or distribute in commerce chemical provisions of TSCA section 12(b) (15
substances and mixtures. The following U.S.C. 2611(b)), (see 40 CFR 721.20),
SUMMARY: Under the Toxic Substance list of North American Industrial and must comply with the export
Control Act (TSCA), EPA is finalizing a Classification System (NAICS) codes is notification requirements in 40 CFR part
significant new use rule (SNUR) for not intended to be exhaustive, but rather 707, subpart D.
trichloroethylene (TCE). The significant provides a guide to help readers
new use is the manufacture or determine whether this document To determine whether you or your
processing for use in a consumer applies to them. Potentially affected business may be affected by this action,
product, with an exception for use of entities may include: you should carefully examine the
TCE in cleaners and solvent degreasers, applicability provisions in 40 CFR
film cleaners, hoof polishes, lubricants, • Textile Product Mills (NAICS code 721.5. If you have any questions
mirror edge sealants, and pepper spray. 314). regarding the applicability of this action
Persons subject to the SNUR will be to a particular entity, consult the
required to notify EPA at least 90 days • Wood Product Manufacturing technical information contact listed
before commencing any manufacturing (NAICS code 321). under FOR FURTHER INFORMATION
or processing of TCE for a significant CONTACT.
new use. The required notification will • Printing and Related Support
provide EPA with the opportunity to Activities (NAICS code 323). B. What is the agency’s authority for
evaluate the intended use and, if taking this action?
necessary based on the information • Chemical Manufacturing (NAICS
available at that time, an opportunity to code 325). Section 5(a)(2) of TSCA (15 U.S.C.
protect against potential unreasonable 2604(a)(2)) authorizes EPA to determine
risks, if any, from that activity before it • Plastics and Rubber Product that a use of a chemical substance is a
occurs. Manufacturing (NAICS code 326). ‘‘significant new use.’’ EPA must make
this determination by rule after
DATES: This final rule is effective • Primary Metal Manufacturing considering all relevant factors,
June 7, 2016. (NAICS code 331). including those listed in TSCA section
5(a)(2). Once EPA determines that a use
ADDRESSES: The docket for this action, • Fabricated Metal Product of a chemical substance is a significant
identified by docket identification (ID) Manufacturing (NAICS code 332). new use, TSCA section 5(a)(1)(B)
number EPA–HQ–OPPT–2014–0697, is requires persons to submit a significant
available at http://www.regulations.gov • Machinery Manufacturing (NAICS new use notice (SNUN) to EPA at least
or at the Office of Pollution Prevention code 333). 90 days before they manufacture
and Toxics Docket (OPPT Docket), (including import) or process the
Environmental Protection Agency • Computer and Electronic Product chemical substance for that use (15
Docket Center (EPA/DC), West William Manufacturing (NAICS code 334). U.S.C. 2604(a)(1)(B)). As described in
Jefferson Clinton Bldg., Rm. 3334, 1301 Unit V., the general SNUR provisions
Constitution Ave. NW., Washington, • Electrical Equipment, Appliance, are found at 40 CFR part 721, subpart
DC. The Public Reading Room is open and Component Manufacturing (NAICS A.
from 8:30 a.m. to 4:30 p.m., Monday code 335).
through Friday, excluding legal C. What action is the agency taking?
holidays. The telephone number for the • Transportation Equipment
Public Reading Room is (202) 566–1744, Manufacturing (NAICS code 336). This final SNUR will require persons
and the telephone number for the OPPT to notify EPA at least 90 days before
Docket is (202) 566–0280. Please review • Furniture and Product Related commencing the manufacture
the visitor instructions and additional Manufacturing (NAICS code 337). (including import) or processing of TCE
information about the docket available for use in a consumer product except for
at http://www.epa.gov/dockets. • Miscellaneous Manufacturing use in cleaners and solvent degreasers,
(NAICS code 339). film cleaners, hoof polishes, lubricants,
FOR FURTHER INFORMATION CONTACT: For mirror edge sealants, and pepper spray.
technical information contact: Tyler • Clothing and Clothing Accessory
Lloyd, Chemical Control Division Stores (NAICS code 488). The SNUR was proposed in the
(7405M), Office of Pollution Prevention Federal Register of August 7, 2015 (80
and Toxics, Environmental Protection • Warehousing and Storage (NAICS FR 47441) (FRL–9930–33) (Ref. 1).
Agency, 1200 Pennsylvania Ave. NW., code 493). Please consult the August 7, 2015
Washington, DC 20460–0001; telephone Federal Register document for further
number: (202) 564–4016; email address: • Repair and Maintenance (NAICS background information for this final
[email protected]. code 811). rule. Additionally, please note that the

• 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

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20536 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations

asabaliauskas on DSK3SPTVN1PROD with RULES RIN for the proposed SNUR was residence, in or around a school, or in the use according to the specific
inadvertently published as RIN 2070– recreation.’’ parameters and circumstances
AK50. This final SNUR bears the correct surrounding that intended use.
identification, RIN 2070–AK05. EPA III. Rationale and Objectives
received 4 public comments on the B. Objectives
proposal and EPA’s response to those A. Rationale
comments appear in Unit X. Based on the considerations in Unit
As discussed in detail in Units II and III.A., EPA will achieve the following
D. Why is the agency taking this action? III of the proposed rule (80 FR 47441; objectives with regard to the significant
August 7, 2015), TCE has the potential new use(s) that are designated in this
This SNUR is necessary to ensure that to induce neurotoxicity, final rule:
EPA receives timely advance notice of immunotoxicity, developmental
any future manufacturing and toxicity, liver toxicity, kidney toxicity, 1. EPA will receive notice of any
processing of TCE for new uses that may endocrine effects, and several forms of person’s intent to manufacture or
produce changes in human and cancer (Ref. 3). EPA is concerned about process TCE for the described
environmental exposures. The rationale the adverse health effects of TCE significant new use before that activity
and objectives for this SNUR are resulting from commercial and begins.
explained in Unit III. consumer uses of the chemical
substance. In EPA’s final risk 2. EPA will have an opportunity to
E. What are the estimated incremental assessment of TCE, released on June 25, review and evaluate data submitted in a
impacts of this action? 2014, the Agency identified risks to SNUN before the notice submitter
workers using TCE and to bystanders for begins manufacturing or processing TCE
EPA has evaluated the potential costs use as degreasers and a spot-cleaner in for the described significant new use.
of establishing SNUR reporting dry cleaning uses, and EPA also
requirements for potential identified health risks to consumers 3. EPA will be able to regulate
manufacturers and processors of TCE. using spray aerosol degreasers and spray prospective manufacturers or processors
This analysis (Ref. 2), which is available fixatives (Ref. 3). of TCE before the described significant
in the docket, is discussed in Unit IX., new use of the chemical substance
and is briefly summarized here. EPA believes that any additional use occurs, provided that regulation is
of this chemical substance in consumer warranted pursuant to TSCA section
In the event that a SNUN is products could significantly increase 5(e), 5(f), 6, or 7.
submitted, costs are estimated to be less human exposure, and that such
than $8,900 per SNUN submission for exposures should not occur without an IV. Significant New Use Determination
large business submitters and $6,500 for opportunity for EPA review and control
small business submitters. These as appropriate. However, as discussed Section 5(a)(2) of TSCA states that
estimates include the cost to prepare in Unit II of the proposed rule (80 FR EPA’s determination that a use of a
and submit the SNUN and the payment 47441; August 7, 2015), based on review chemical substance is a significant new
of a user fee. The SNUR requires first- of Safety Data Sheets and the National use must be made after consideration of
time submitters of any TSCA section 5 Institutes of Health’s Household all relevant factors including:
notice to register their company and key Products Database, EPA believes that
users with the CDX reporting tool, cleaners and solvent degreasers, film 1. The projected volume of
deliver a CDX electronic signature to cleaners, hoof polishes, lubricants, manufacturing and processing of a
EPA, and establish and use a Pay.gov E- mirror edge sealants, and pepper spray chemical substance.
payment account before they may presently contain TCE and are therefore
submit a SNUN, for a cost of ongoing uses of this chemical. EPA 2. The extent to which a use changes
approximately $200 per firm. However, believes that other consumer products the type or form of exposure of human
these activities are only required of first do not presently contain TCE. Spray beings or the environment to a chemical
time submitters of section 5 notices. In fixative product use was discontinued substance.
addition, for persons exporting a by September 1, 2015, as described in
substance that is the subject of a SNUR, Unit II.A of the proposed rule (80 FR 3. The extent to which a use increases
a one-time notice to EPA must be 47441). the magnitude and duration of exposure
provided for the first export or intended of human beings or the environment to
export to a particular country, which is Consistent with EPA’s past practice a chemical substance.
estimated to be approximately $80 per for issuing SNURs under TSCA section
notification. 5(a)(2), EPA’s decision to promulgate a 4. The reasonably anticipated manner
SNUR for a particular chemical use and methods of manufacturing,
II. Chemical Substance Subject to This need not be based on an extensive processing, distribution in commerce,
Rule evaluation of the hazard, exposure, or and disposal of a chemical substance.
potential risk associated with that use.
This final SNUR applies to TCE Rather, the Agency action is based on In addition to these factors
(Chemical Abstract Services Registry EPA’s determination that if the use enumerated in TSCA section 5(a)(2), the
Number (CASRN) 79–01–6) begins or resumes, it may present a risk statute authorizes EPA to consider any
manufactured (including import) or that EPA should evaluate under TSCA other relevant factors.
processed for use in any consumer before the manufacturing or processing
product, except for use in cleaners and for that use begins. Since the new use To determine what would constitute a
solvent degreasers, film cleaners, hoof does not currently exist, deferring a significant new use of TCE, as discussed
polishes, lubricants, mirror edge detailed consideration of potential risks in Unit II of the proposed rule (80 FR
sealants, and pepper spray. A consumer or hazards related to that use is an 47441), EPA considered relevant
product is defined at 40 CFR 721.3 as ‘‘a effective use of resources. If a person information about the toxicity of the
chemical substance that is directly, or as decides to begin manufacturing or substance, likely human exposures and
part of a mixture, sold or made available processing the chemical for the use, the environmental releases associated with
to consumers for their use in or around notice to EPA allows EPA to evaluate possible uses, and the four factors listed
a permanent or temporary household or 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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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 20537

asabaliauskas on DSK3SPTVN1PROD with RULES TCE is not used in consumer products requirements, codified at 19 CFR 12.118 requirements of the final SNUR for
(with the limited exceptions of use in through 12.127; see also 19 CFR 127.28. those activities.
cleaners and solvent degreasers, film Those persons must certify that the
cleaners, hoof polishes, lubricants, shipment of the chemical substance VII. Test Data and Other Information
mirror edge sealants, and pepper spray), complies with all applicable rules and
EPA believes new use in consumer orders under TSCA, including any EPA recognizes that TSCA section 5
products could increase the magnitude SNUR requirements. The EPA policy in does not usually require developing any
and duration of human exposure to support of import certification appears particular test data before submission of
TCE. Exposure to TCE through at 40 CFR part 707, subpart B. a SNUN. There are two exceptions:
inhalation may lead to a wide array of
adverse health effects, such as VI. Applicability of Rule to Uses 1. Development of test data is
neurotoxicity, immunotoxicity, Occurring Before Effective Date of the required where the chemical substance
developmental toxicity, liver toxicity, Final Rule subject to the SNUR is also subject to a
kidney toxicity, endocrine effects, and test rule under TSCA section 4 (see
several forms of cancer, as further As discussed in the Federal Register TSCA section 5(b)(1)); and
explained in Unit II.C of the proposed of April 24, 1990 (55 FR 17376; FRL–
rule (80 FR 47441), and because of these 3658–5) (Ref. 4), EPA has decided that 2. Development of test data may be
potential adverse effects EPA would like the intent of section 5(a)(1)(B) of TSCA necessary where the chemical substance
the opportunity to evaluate such is best served by designating a use as a has been listed under TSCA section
potential uses in consumer products for significant new use as of the date of 5(b)(4) (see TSCA section 5(b)(2)).
any associated risks or hazards that publication of the proposed rule rather
might exist before those uses would than as of the effective date of the final In the absence of a section 4 test rule
begin. rule. If uses begun after publication of or a section 5(b)(4) listing covering the
the proposed rule were considered chemical substance, persons are
V. Applicability of the General ongoing rather than new, it would be required to submit only test data in their
Provisions difficult for EPA to establish SNUR possession or control and to describe
notice requirements, because a person any other data known to or reasonably
General provisions for SNURs appear could defeat the SNUR by initiating the ascertainable by them (15 U.S.C.
under 40 CFR part 721, subpart A. proposed significant new use before the 2604(d); 40 CFR 721.25, and 40 CFR
These provisions describe persons rule became final, and then argue that 720.50). However, as a general matter,
subject to the rule, recordkeeping the use was ongoing as of the effective EPA recommends that SNUN submitters
requirements, exemptions to reporting date of the final rule. Thus, persons who include data that would permit a
requirements, and applicability of the begin commercial manufacture or reasoned evaluation of risks posed by
rule to uses occurring before the processing of TCE after the proposal was the chemical substance during its
effective date of the final rule. published on August 7, 2015, must manufacture, processing, use,
cease such activity before the effective distribution in commerce, or disposal.
Provisions relating to user fees appear date of this final rule. To resume their EPA encourages persons to consult with
at 40 CFR part 700. According to 40 CFR activities, these persons would have to the Agency before submitting a SNUN.
721.1(c), persons subject to SNURs must comply with all applicable SNUR notice As part of this optional pre-notice
comply with the same notice requirements and wait until the notice consultation, EPA would discuss
requirements and EPA regulatory review period, including all extensions, specific data it believes may be useful
procedures as submitters of expires. Uses arising after the in evaluating a significant new use.
Premanufacture Notices (PMNs) under publication of the proposed rule are SNUNs submitted for significant new
TSCA section 5(a)(1)(A). In particular, distinguished from uses that exist at uses without any test data may increase
these requirements include the publication of the proposed rule. The the likelihood that EPA will take action
information submissions requirements former would be new uses, the latter under TSCA section 5(e) to prohibit or
of TSCA section 5(b) and 5(d)(1), the ongoing uses, except that uses that are limit activities associated with this
exemptions authorized by TSCA section ongoing as of the publication of the chemical.
5(h)(1), (h)(2), (h)(3), and (h)(5), and the proposed rule would not be considered
regulations at 40 CFR part 720. Once ongoing uses if they have ceased by the SNUN submitters should be aware
EPA receives a SNUN, EPA may take date of issuance of a final rule. that EPA will be better able to evaluate
regulatory action under TSCA section However, recognizing that use in a SNUNs that provide detailed
5(e), 5(f), 6, or 7 to control the activities consumer product of TCE in spray information on:
on which it has received the SNUN. If fixatives was to cease and did cease by
EPA does not take action, EPA is September 1, 2015 as described in Unit • Human exposure and
required under TSCA section 5(g) to II.A. of the proposed rule (80 FR 47441), environmental releases that may result
explain in the Federal Register its EPA considers September 1, 2015 as the from the significant new uses of the
reasons for not taking action. date from which the significant new use chemical substance;
with respect only to such spray fixatives
Persons who export or intend to would be designated. Public • Potential benefits of the chemical
export a chemical substance identified commenters on the proposed rule did substance; and
in a proposed or final SNUR are subject not identify any additional ongoing
to the export notification provisions of uses. EPA has promulgated provisions • Information on risks posed by the
TSCA section 12(b). The regulations that to allow persons to comply with this chemical substances compared to risks
interpret TSCA section 12(b) appear at SNUR before the effective date. If a posed by potential substitutes.
40 CFR part 707, subpart D. In person were to meet the conditions of
accordance with 40 CFR 707.60(b), this advance compliance under 40 CFR VIII. SNUN Submissions
final SNUR does not trigger export 721.45(h), that person would be
notification for articles. Persons who considered to have met the EPA recommends that submitters
import a chemical substance identified consult with the Agency prior to
in a final SNUR are subject to the TSCA submitting a SNUN to discuss what data
section 13 import certification 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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20538 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations

asabaliauskas on DSK3SPTVN1PROD with RULES must comply with the same notice X. Response to Public Comment lubricants, mirror edge sealants, and
requirements and EPA regulatory pepper spray. (Docket ID# EPA–HQ–
procedures as persons submitting a The Agency reviewed and considered OPPT–2014–0697–0011.)
PMN, including submission of test data all comments received related to the
on health and environmental effects as proposed rule. Copies of all comments Response. EPA acknowledges the
described in 40 CFR 720.50. SNUNs are available in the docket for this comment.
must be submitted on EPA Form No. action (EPA–HQ–OPPT–2014–0697). A
7710–25, generated using e-PMN discussion of the major comments 4. Comment. One commenter asks the
software, and submitted to the Agency germane to the rulemaking and the Agency to ‘‘rescind any exemption to
in accordance with the procedures set Agency’s responses follow. issuing a notice to any party looking to
forth in 40 CFR 721.25 and 40 CFR begin using TCE in the production of
720.40. E–PMN software is available A. Support for TCE SNUR any consumer good’’ because TCE ‘‘is
electronically at http://www.epa.gov/ known to be a volatile organic
opptintr/newchems. 1. Comment. One commenter compound (VOC) with a close
supports the proposed rule and association with many adverse health
IX. Economic Analysis reiterates human health effects related and environmental effects.’’ (Docket ID#
to TCE exposure. (Docket ID# EPA–HQ– EPA–HQ–OPPT–2014–0697–0008.)
A. SNUNs OPPT–2014–0697–0009.)
Response. EPA acknowledges the
EPA has evaluated the potential costs Response. EPA acknowledges the comment. As described in Unit III.A., by
of establishing SNUR reporting comment. issuing this final rule EPA defers, if and
requirements for potential until such time as a SNUN is submitted,
manufacturers and processors of the 2. Comment. One commenter the opportunity to evaluate the use
chemical substance included in this supports the proposed rule and asks according to the specific parameters and
final rule (Ref. 2). In the event that a EPA to (a) ‘‘broaden the scope of the circumstances surrounding that
SNUN is submitted, costs are estimated SNUR to: (1) Include certain commercial intended use before such use could
at approximately $8,900 per SNUN uses of TCE, and (2) regularly review occur. In the event that a SNUN is
submission for large business submitters ongoing uses of TCE and update the submitted, EPA will follow all
and $6,500 for small business SNUR to include any discontinued regulations and guidelines, pursuant to
submitters. These estimates include the uses’’ and (b) ‘‘promptly promulgate a TSCA section 5(a)(2), that guide the
cost to prepare and submit the SNUN, TSCA section 6(a) rule to address assessment of any environmental and
and the payment of a user fee. identified risks of TCE from ongoing health concerns resulting from the
Businesses that submit a SNUN would uses.’’ (Docket ID# EPA–HQ–OPPT– Significant New Use.
be subject to either a $2,500 user fee 2014–0697–0010.)
required by 40 CFR 700.45(b)(2)(iii), or, B. Review of Work Plan Chemical Risk
if they are a small business with annual Response. The commenter points out Assessment
sales of less than $40 million when that there are ‘‘widespread ongoing
combined with those of the parent commercial uses of TCE.’’ Currently 1. Comment. One commenter
company (if any), a reduced user fee of ongoing commercial uses of TCE cannot contends that the final Work Plan
$100 (40 CFR 700.45(b)(1)). EPA’s be included in the SNUR. EPA will Chemical Risk Assessment ‘‘should not
complete economic analysis is available continue to monitor uses of TCE and serve as the basis for regulation’’ and
in the public docket for this final rule consider promulgating future SNURs for notes specific concerns with it, asking
(Ref. 2). discontinued or other non-ongoing uses. EPA to respond to each. (Docket ID#
EPA–HQ–OPPT–2014–0697–0011.)
B. Export Notification TSCA section 6 provides authority for
EPA to ban or restrict the manufacture Response. The peer-reviewed Work
Under section 12(b) of TSCA and the (including import), processing, Plan Chemical Risk Assessment
implementing regulations at 40 CFR part distribution in commerce, and use of referenced by the commenter includes
707, subpart D, exporters must notify chemicals, as well as any manner or an assessment of the hazard of TCE. As
EPA if they export or intend to export method of disposal. EPA identified TCE described in the risk assessment, TCE is
a chemical substance or mixture for for risk evaluation as part of its Work carcinogenic to humans and TCE
which, among other things, a rule has Plan for Chemical Assessment under exposure is associated with a range of
been proposed or promulgated under TSCA. TCE is used in industrial and non-cancer health effects in humans and
TSCA section 5. For persons exporting commercial processes, and also has animals, including developmental
a substance that is the subject of a some limited uses in consumer toxicity, immunotoxicity, kidney
SNUR, a one-time notice to EPA must be products. In the June 2014 TSCA Work toxicity, reproductive toxicity,
provided for the first export or intended Plan Chemical Risk Assessment, EPA neurotoxicity and liver toxicity. While
export to a particular country. The total identified risks associated with EPA considered relevant information
costs of export notification will vary by commercial degreasing and some about the toxicity of the substance,
chemical, depending on the number of consumer uses. EPA is initiating likely human exposures and
required notifications (i.e., the number rulemaking under TSCA section 6 to environmental releases associated with
of countries to which the chemical is address these risks. Specifically, EPA possible uses, and the four factors listed
exported). While EPA is unable to make will determine whether the use of TCE in section 5(a)(2) of TSCA (80 FR
any estimate of the likely number of in some commercial degreasing uses, as 47441), EPA believes that the
export notifications for the chemical a spotting agent in dry cleaning, and in commenter’s specific concerns are not
covered in this final SNUR, as stated in certain consumer products presents an relevant to the ‘‘basis for regulation’’ for
the accompanying economic analysis of unreasonable risk to human health and this SNUR.
this final SNUR, the estimated cost of the environment such that regulation is
the export notification requirement on a warranted under TSCA section 6. Under section 5(a)(2), EPA is neither
per unit basis is approximately $80. required to determine that a particular
3. Comment. One commenter agrees new use of any chemical substances
with the EPA’s understanding that TCE presents, nor even that it may present,
is not widely used, with the exception an unreasonable risk to human health or
of TCE in cleaners and solvent, the environment. Rather, EPA issues a
degreasers, film cleaners, hoof polishes, SNUR for a particular new use of a

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Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 20539

asabaliauskas on DSK3SPTVN1PROD with RULES substance if it has reason to anticipate control number 2070–0030 (EPA ICR experience to date is that, in response to
that the use would raise significant No. 0795). If an entity were to submit a the promulgation of SNURs covering
questions related to potential exposure, SNUN to the Agency, the annual burden over 1,000 chemical substances, the
so that it should have an opportunity to is estimated to be less than 100 hours Agency receives only a handful of
review the use before such use should per response, and the estimated burden notices per year. During the six year
occur. As discussed in Unit IV, EPA for export notifications is less than 1.5 period from 2005–2010, only three
based this judgement on a consideration hours per notification. In both cases, submitters self-identified as small in
of all relevant factors, including the burden is estimated to be reduced for their SNUN submission (Ref. 2). EPA
specific factors identified at section submitters who have already registered believes the cost of submitting a SNUN
5(a)(2). to use the electronic submission system. is relatively small compared to the cost
of developing and marketing a chemical
XI. References An agency may not conduct or new to a firm or marketing a new use
sponsor, and a person is not required to of the chemical and that the
The following is a listing of the respond to a collection of information requirement to submit a SNUN
documents that are specifically that requires OMB approval under the generally does not have a significant
referenced in this document. The docket PRA, unless it has been approved by economic impact.
includes these documents and other OMB and displays a currently valid
information considered by EPA, OMB control number. The OMB control Therefore, EPA believes that the
including documents that are referenced numbers for EPA’s regulations in title 40 potential economic impact of complying
within the documents that are included of the CFR, after appearing in the with this final SNUR is not expected to
in the docket, even if the referenced Federal Register, are listed in 40 CFR be significant or adversely impact a
document is not physically located in part 9, and included on the related substantial number of small entities. In
the docket. For assistance in locating collection instrument, or form, if a SNUR that published as a final rule on
these other documents, please consult applicable. EPA is amending the table in August 8, 1997 (62 FR 42690) (FRL–
the technical person listed under FOR 40 CFR part 9 to list this SNUR. This 5735–4), the Agency presented its
FURTHER INFORMATION CONTACT. listing of the OMB control numbers and general determination that proposed
their subsequent codification in the CFR and final SNURs are not expected to
1. EPA. Trichloroethylene (TCE); satisfies the display requirements of the have a significant economic impact on
Significant New Use Rule; TCE in Certain PRA and OMB’s implementing a substantial number of small entities.
Consumer Products; Proposed Rule. Federal regulations at 5 CFR part 1320. Since
Register (80 FR 47441, August 7, 2015) (FRL– the existing OMB approval was D. Unfunded Mandates Reform Act
9930–33). previously subject to public notice and (UMRA)
comment before OMB approval, and
2. EPA. Economic Analysis for the Final given the technical nature of the table, Based on EPA’s experience with
Significant New Use Rule for EPA finds that further notice and proposing and finalizing SNURs, State,
Trichloroethylene (TCE). March 10, 2016. comment to amend the table is local, and Tribal governments have not
unnecessary. As a result, EPA finds that been impacted by these rulemakings,
3. EPA. TSCA Workplan Chemical Risk there is ‘‘good cause’’ under section and EPA does not have any reason to
Assessment—Trichloroethylene: Degreasing, 553(b)(3)(B) of the Administrative believe that any State, local, or Tribal
Spot Cleaning and Arts & Crafts Uses; Procedure Act, 5 U.S.C. 553(b)(3)(B), to government would be impacted by this
Supporting and Related Material. June 25, amend this table without further notice rulemaking. As such, the requirements
2014. and comment. of sections 202, 203, 204, or 205 of
UMRA, 2 U.S.C. 1531–1538, do not
4. EPA. Significant New Uses of Certain C. Regulatory Flexibility Act (RFA) apply to this action.
Chemical Substances; Final Rule. Federal
Register (55 FR 17376, April 24, 1990) (FRL– Pursuant to section 605(b) of the RFA, E. Executive Order 13132: Federalism
3658–5). 5 U.S.C. 601 et seq., I certify that this
action will not have a significant This action will not have a substantial
XII. Statutory and Executive Order economic impact on a substantial direct effect on States, on the
Reviews number of small entities. relationship between the national
government and the States, or on the
A. Executive Order 12866: Regulatory A SNUR applies to any person distribution of power and
Planning and Review and Executive (including small or large entities) who responsibilities among the various
Order 13563: Improving Regulation and intends to engage in any activity levels of government, as specified in
Regulatory Review described in the rule as a ‘‘significant Executive Order 13132 (64 FR 43255,
new use.’’ By definition of the word August 10, 1999).
This action is not a significant ‘‘new’’ and based on all information
regulatory action and was therefore not currently available to EPA, it appears F. Executive Order 13175: Consultation
submitted to the Office of Management that no small or large entities presently and Coordination With Indian Tribal
and Budget (OMB) for review under engage in such activities. Since this Governments
Executive Orders 12866 (58 FR 51735, SNUR will require a person who intends
October 4, 1993) and 13563 (76 FR 3821, to engage in such activity in the future This final rule does not have Tribal
January 21, 2011). to first notify EPA by submitting a implications because it is not expected
SNUN, no economic impact will occur to have any effect (i.e., there will be no
B. Paperwork Reduction Act (PRA) unless someone files a SNUN to pursue increase or decrease in authority or
a significant new use in the future or jurisdiction) on Tribal governments, on
This action does not impose any new forgoes profits by avoiding or delaying the relationship between the Federal
information collection burden under the the significant new use. Although some government and the Indian tribes, or on
PRA, 44 U.S.C. 3501 et seq. Burden is small entities may decide to conduct the distribution of power and
defined in 5 CFR 1320.3(b). The such activities in the future, EPA cannot responsibilities between the Federal
information collection activities presently determine how many, if any, government and Indian tribes. Thus,
associated with existing chemical there may be. However, EPA’s Executive Order 13175 (65 FR 67249,
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

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20540 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations

November 9, 2000) does not apply to 40 CFR Part 721 cleaners and solvent degreasers, film
this action. cleaners, hoof polishes, lubricants,
Environmental protection, Chemicals, mirror edge sealants, and pepper spray.
G. Executive Order 13045: Protection of Hazardous substances, Reporting and
Children From Environmental Health recordkeeping requirements. (b) [Reserved]
Risks and Safety Risks
Dated: April 4, 2016. [FR Doc. 2016–08152 Filed 4–7–16; 8:45 am]
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997), as Wendy Cleland-Hamnett, BILLING CODE 6560–50–P
applying only to those regulatory
actions that concern environmental Director, Office of Pollution Prevention and ENVIRONMENTAL PROTECTION
health or safety risks that EPA has Toxics. AGENCY
reason to believe may
disproportionately affect children, per Therefore, 40 CFR chapter I is 40 CFR Part 52
the definition of ‘‘covered regulatory amended as follows:
action’’ in section 2–202 of the [EPA–R03–OAR–2015–0773; FRL–9944–73–
Executive Order. This action is not PART 9—[AMENDED] Region 3]
subject to Executive Order 13045
because it does not concern an ■ 1. The authority citation for part 9 Approval and Promulgation of Air
environmental health risk or safety risk. continues to read as follows: Quality Implementation Plans;
Pennsylvania; Attainment Plan and
H. Executive Order 13211: Actions Authority: 7 U.S.C. 135 et seq., 136–136y; Base Year Inventory for the North
Concerning Regulations That 15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671; Reading Area for the 2008 Lead
Significantly Affect Energy Supply, 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 National Ambient Air Quality
Distribution, or Use U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, Standards
1321, 1326, 1330, 1342, 1344, 1345 (d) and
This final rule is not subject to (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, AGENCY: Environmental Protection
Executive Order 13211 (66 FR 28355, 1971–1975 Comp. p. 973; 42 U.S.C. 241, Agency (EPA).
May 22, 2001), because this action is not 242b, 243, 246, 300f, 300g, 300g–1, 300g–2, ACTION: Final rule.
expected to affect energy supply, 300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
distribution, or use. 300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., SUMMARY: The Environmental Protection
6901–6992k, 7401–7671q, 7542, 9601–9657, Agency (EPA) is approving a state
I. National Technology Transfer and 11023, 11048. implementation plan (SIP) revision
Advancement Act (NTTAA) ■ 2. In § 9.1, add the following section submitted by the Commonwealth of
in numerical order under the Pennsylvania (Pennsylvania). The
Since this action does not involve any undesignated center heading revision demonstrates attainment of the
technical standards, section 12(d) of ‘‘Significant New Uses of Chemical 2008 lead national ambient air quality
NTTAA, 15 U.S.C. 272 note, does not Substances’’ to read as follows: standards (NAAQS) in the North
apply to this action. Reading 2008 lead nonattainment area
§ 9.1 OMB approvals under the Paperwork (North Reading Area or Area). The
J. Executive Order 12898: Federal Reduction Act. attainment plan includes the base year
Actions To Address Environmental emissions inventory, an analysis of
Justice in Minority Populations and ***** reasonably available control technology
Low-Income Populations (RACT), reasonably available control
40 CFR citation OMB Control measures (RACM), and reasonable
This final rule does not invoke special number further progress (RFP), modeling
consideration of environmental justice demonstration of lead attainment, and
related issues as delineated by ***** contingency measures for the Area. EPA
Executive Order 12898 (59 FR 7629, Significant New Uses of Chemical is approving Pennsylvania’s lead
February 16, 1994), because EPA has Substances attainment plan with the base year
determined that this action will not emissions inventory for the North
have disproportionately high and ***** Reading Area as a revision to
adverse human health or environmental Pennsylvania’s SIP in accordance with
effects on minority or low-income 721.10851 ............................. 2070–0038 the requirements of the Clean Air Act
populations. This action does not affect (CAA).
the level of protection provided to *****
human health or the environment. DATES: This final rule is effective on
***** May 9, 2016.
XIII. Congressional Review Act (CRA) ADDRESSES: EPA has established a
asabaliauskas on DSK3SPTVN1PROD with RULES PART 721—[AMENDED] docket for this action under Docket ID
This action is subject to the CRA, 5 Number EPA–R03–OAR–2015–0773. All
U.S.C. 801 et seq., and the EPA will ■ 3. The authority citation for part 721 documents in the docket are listed in
submit a rule report to each House of continues to read as follows: the www.regulations.gov Web site.
Congress and the Comptroller of the Although listed in the electronic docket,
United States. This action is not a Authority: 15 U.S.C. 2604, 2607, and some information is not publicly
‘‘major rule’’ as defined by 5 U.S.C. 2625(c). available, i.e., confidential business
804(2). information (CBI) or other information
■ 4. Add § 721.10851 to subpart E to whose disclosure is restricted by statute.
List of Subjects read as follows: Certain other material, such as
copyrighted material, is not placed on
40 CFR Part 9 § 721.10851 Trichloroethylene. the Internet and will be publicly
(a) Chemical substance and available only in hard copy form.
Environmental protection, Reporting Publicly available docket materials are
and recordkeeping requirements. 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

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