82 FR 26644 - Significant New Use Rule on Certain Chemical Substances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 109 (June 8, 2017)

EPA is proposing a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for one chemical substance that was the subject of a premanufacture notice (PMN). The applicable review period for the PMN submitted for this chemical substance ended prior to June 22, 2016, the date on which President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (which amends TSCA). This action would require persons who intend to manufacture (defined by statute to include import) or process the chemical substance for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and take such actions as are required with that determination.

[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Proposed Rules]
[Pages 26644-26649]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-11695]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2016-0207; FRL-9959-37]
RIN 2070-AB27


Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under the 
Toxic Substances Control Act (TSCA) for one chemical substance that was 
the subject of a premanufacture notice (PMN). The applicable review 
period for the PMN submitted for this chemical substance ended prior to 
June 22, 2016, the date on which President Obama signed into law the 
Frank R. Lautenberg Chemical Safety for the 21st Century Act (which 
amends TSCA). This action would require persons who intend to 
manufacture (defined by statute to include import) or process the 
chemical substance for an activity that is designated as a significant 
new use by this proposed rule to notify EPA at least 90 days before 
commencing that activity. The required notification initiates EPA's 
evaluation of the intended use within the applicable review period. 
Manufacture and processing for the significant new use is unable to 
commence until EPA has conducted a review of the notice, made an 
appropriate determination on the notice, and take such actions as are 
required with that determination.

DATES: Comments must be received on or before July 10, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0207, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substance contained in this proposed rule. 
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

[[Page 26645]]

determine whether this document applies to them. Potentially affected 
entities may include:
    Manufacturers (including importers) or processors of the subject 
chemical substance (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the 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 to a proposed or final rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
Sec.  721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing this SNUR under TSCA section 5(a)(2) for the 
chemical substance that was the subject of PMN P-11-482. This SNUR 
would require persons who intend to manufacture or process this 
chemical substance for an activity that is designated as a significant 
new use to notify EPA at least 90 days before commencing that activity. 
In accordance with the procedures at Sec.  721.160(c)(3)(i), in the 
Federal Register publication of November 17, 2016 (81 FR 81250) (FRL-
9953-41) EPA issued a direct final SNUR on this chemical substance, 
which is the subject of a PMN. EPA received a notice of intent to 
submit adverse comments on this SNUR. Therefore, as required by Sec.  
721.160(c)(3)(ii), EPA withdrew the direct final SNURs in the Federal 
Register of January 19, 2017 (82 FR 6277) (FRL-9958-20), and is now 
issuing this proposed rule on the chemical substance. The records for 
the direct final SNUR on the chemical substance were established as 
docket EPA-HQ-OPPT-2016-0207. Those records include information 
considered by the Agency in developing the direct final rule. While 
notices of intent to submit adverse comments were received during the 
direct final rule phase, only one substantive comment was submitted. 
The commenter noted a discrepancy between requirements in the consent 
order and SNUR. While the consent order allows limited surface water 
releases from the manufacturing process, the direct final SNUR 
designated as a significant new use any purposeful or predictable 
releases to surface waters. To make the SNUR consistent with consent 
order requirements, in this proposed SNUR EPA has designated as a 
significant new use any predictable or purposeful releases to water 
from manufacturing, processing, or use other than the water releases 
described in the PMN for the manufacturing process of P-11-482. EPA 
awaits further comment during the open comment period for this proposed 
rule.

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 the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. 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 or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 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 Sec.  721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission 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 must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury or take such regulatory action as is associated with an 
alternative determination before the manufacture or processing for the 
significant new use can commence. If EPA determines that the 
significant new use is not likely to present an unreasonable risk, EPA 
is required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. 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:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing,

[[Page 26646]]

processing, distribution in commerce, and disposal of a chemical 
substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for one chemical substance in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for the chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (assigned 
for non-confidential chemical identities).
     Public comments and EPA's response to comments on the 
direct final SNURs.
     Basis for the TSCA non-section 5(e) SNURs (i.e., SNURs 
without TSCA section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits (i.e., limits on manufacture volume) 
and other uses designated in this proposed rule, may be claimed as CBI.

PMN Number P-11-482

    Chemical name: Bimodal mixture consisting of multi-walled carbon 
nanotubes and other classes of carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic use of the PMN 
substance will be as a specialty additive. Based on test data on 
analogous respirable, poorly soluble particulates and nanocarbon 
materials, EPA identified concerns for pulmonary toxicity and 
oncogenicity. Based on test data for other nanocarbon materials EPA 
identified concerns for environmental toxicity. The Order was issued 
under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a 
finding that the substance may present an unreasonable risk of injury 
to human health and the environment. To protect against these risks, 
the consent order requires:
    1. Use of personal protective equipment involving impervious gloves 
and protective clothing (where there is a potential for dermal 
exposures) and a National Institute for Occupational Safety and Health 
(NIOSH)-certified air purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 cartridges, or power air purifying 
particulate respirator with an Assigned Protection Factor (APF) of at 
least 50 (where there is a potential for inhalation exposures).
    2. Submission of a dustiness test within six months of notice of 
commencement of manufacture (NOC).
    3. Submission of certain physical chemical properties data within 
the time limits specified in the consent order.
    4. Processing and use of the PMN substance only for the use 
specified in the consent order, including no application method that 
generates a vapor, mist or aerosol unless the application method occurs 
in an enclosed process.
    5. No predictable or purposeful releases to water from 
manufacturing, processing, or use other than the water releases 
described in the PMN for the manufacturing process of P-11-482 and 
disposal of the PMN substance only by landfill or incineration.
    The SNUR would designate as a ``significant new use'' the absence 
of these protective measures.
    Recommended testing: EPA has determined that the development of 
data on certain physical-chemical properties, as well as certain human 
health and environmental toxicity testing would help characterize 
possible effects of the substance. The submitter has agreed to provide 
a dustiness test (European Standard EU 15051) by six months from 
commencement of manufacture. In addition, the submitter has agreed to 
provide certain physical chemical property testing as required in the 
consent order after the commencement of manufacture.
    Although the order does not require a 90-day inhalation toxicity 
test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-
operation and Development (OECD) Test Guideline 413) in rats with a 
post-exposure observation period of up to 9 months (including BALF 
analysis, a determination of cardiovascular toxicity (clinically-based 
blood/plasma protein analyses), and histopathology of the heart), a 
two-year inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early 
life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal 
toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions 
on manufacture, processing, distribution in commerce, and disposal will 
remain in effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.10927.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMN submitted for the chemical substance that 
is subject to this SNUR, EPA determined that one or more of the 
criteria of concern established at Sec.  721.170 were met. For 
additional discussion on this chemical substance, see Units II. and IV. 
of this proposed rule.

B. Objectives

    EPA is proposing this SNUR for specific chemical substance which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture or process the listed chemical substance for the described 
significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing the listed chemical substance for the described significant 
new use.
     EPA would be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
https://www.epa.gov/tsca-inventory.

[[Page 26647]]

VI. Applicability of the Proposed Rule to Uses Occurring Before the 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substance subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When the chemical substance identified in this proposed rule is 
added to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. The identity of the chemical substance 
subject to this proposed rule has been claimed as confidential and EPA 
has received no post-PMN bona fide submissions (per Sec. Sec.  720.25 
and 721.11). Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates February 28, 2017 (the date of public 
release/web posting of this proposed rule), as the cutoff date for 
determining whether the new use is ongoing. This designation varies 
slightly from EPA's past practice of designating the date of Federal 
Register publication as the date for making this determination. The 
objective of EPA's approach has been to ensure that a person could not 
defeat a SNUR by initiating a significant new use before the effective 
date of the proposed rule. In developing this proposed rule, EPA has 
recognized that, given EPA's practice of now posting rules on its Web 
site a week or more in advance of Federal Register publication, this 
objective could be thwarted even before that publication. Thus, EPA has 
slightly modified its approach in this rulemaking and plans to follow 
this modified approach in future significant new use rulemakings.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date would have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons would have to 
first comply with all applicable SNUR notification requirements and 
wait until the notice review period, including any extensions, expires. 
If such a person met the conditions of advance compliance under Sec.  
721.45(h), the person would be considered exempt from the requirements 
of the SNUR. Consult the Federal Register document of April 24, 1990 
(55 FR 17376) for a more detailed discussion of the cutoff date for 
ongoing uses.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: Development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Descriptions of tests are provided for 
informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Guidelines for Pesticides and Toxic Substances.''
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs and define the terms of any potentially necessary 
controls if the submitter provides detailed information on the 
following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

VIII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification 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 720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

IX. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the risk assessment documents included in the public docket. These 
information sources supply information relevant to whether a particular 
use would be a significant new use, based on relevant factors including 
those listed under TSCA section 5(a)(2).
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
this proposed significant new use rule, in Unit II and in the documents 
noted above. EPA recognizes, based on the available information, that 
there is variability and uncertainty in whether any particular 
significant new use would actually present an unreasonable risk. For 
precisely this reason, it is appropriate to secure a future notice and 
review process for these uses, at such time as they are known more 
definitely. The extent to which the various information, procedures, 
measures, methods, protocols, methodologies or models used in EPA's 
decision have been subject to independent verification or peer review 
is adequate to justify their use, collectively, in the record for a 
significant new use rule.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule, during the development of the 
direct final rule. EPA's complete economic analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2016-0207.

[[Page 26648]]

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNUR for the chemical substance 
that was the subject of PMN. The Office of Management and Budget (OMB) 
has exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), 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 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.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This proposed rule would 
not impose any burden requiring additional OMB approval. If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
average between 30 and 170 hours per response. This burden estimate 
includes the time needed to review instructions, search existing data 
sources, gather and maintain the data needed, and complete, review, and 
submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
proposed rule.
    This proposed rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit IX. And 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not 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 reasons to believe that any 
State, local, or Tribal government would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This proposed rule would 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, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this proposed rule does not address environmental 
health or safety risks disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any 
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would 
not apply to this proposed rule.

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: February 21, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

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

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

0
2. Add Sec.  721.10927 to subpart E to read as follows:

[[Page 26649]]

Sec.  721.10927  Bimodal mixture consisting of multi-walled carbon 
nanotubes and other classes of carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as a 
bimodal mixture consisting of multi-walled carbon nanotubes and other 
classes of carbon nanotubes (PMN P-11-482) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63 (a)(1) and (a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. A National 
Institute for Occupational Safety and Health (NIOSH)-certified air 
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator 
with an Assigned Protection Factor (APF) of at least 50 meets the 
requirements of Sec.  721.63 (a)(4).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k) and (q). A significant new use is any 
use involving an application method that generates a vapor, mist or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) Release to water. Requirements as specified in Sec.  721.90 
(b)(1) and (c)(1). Any predictable or purposeful release of a 
manufacturing stream associated with any use of the substance from any 
site is a significant new use other than the water releases described 
in the manufacturing process of PMN P-11-482.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (e), (i), (j), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725 (b)(1) apply to paragraph (a)(2)(ii) 
of this section.

[FR Doc. 2017-11695 Filed 6-7-17; 8:45 am]
BILLING CODE 6560-50-P