[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Proposed Rules]
[Pages 52179-52187]
[FR Doc No: 2018-22397]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2017-0575; FRL-9984-93]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 13 chemical substances which
are the subject of premanufacture notices (PMNs). This action would
require persons to notify EPA at least 90 days before commencing
manufacture (defined by statute to include import) or processing of any
of these 13 chemical substances for an activity that is designated as a
significant new use by this proposed rule. If this proposed rule

is made final, persons may not commence manufacture or processing for
the significant new use until they have submitted a Significant New Use
Notice, and EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken any actions as
are required as a result of that determination.

DATES: Comments must be received on or before November 15, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0575], 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:<PHONE_NUMBER>; 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 substances 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 determine whether this document
applies to them. Potentially affected entities may include:
     Manufacturers or processors of one or more subject
chemical substances (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 proposed SNURs
would need to certify their compliance with the SNUR requirements
should these proposed rules be finalized. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20, any persons who export or intend
to export a chemical substance that is the subject of this proposed
rule on or after November 15, 2018 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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 CBI 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 these SNURs under TSCA section 5(a)(2) for 13
chemical substances which were the subjects of PMNs P-16-192, P-16-354
and P-16-355, P-16-380 through P-16-385, P-16-483 and P-16-484, P-16-
575, and P-16-581. These proposed SNURs would require persons who
intend to manufacture or process any of these chemical substances for
an activity that is designated as a significant new use to notify EPA
at least 90 days before commencing that activity.
    The record for the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2017-0575. That record includes
information considered by the Agency in developing these proposed
SNURs.

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)(i)
(15 U.S.C. 2604(a)(1)(B)(i)) 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. TSCA prohibits such
manufacturing or processing from commencing until EPA has conducted a
review of the SNUN, made an appropriate determination on the SNUN, 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 rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant 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) (15 U.S.C. 2604(a)(1)(A)). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(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, 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 significant new uses for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of 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 13 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
    This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information identified by EPA was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VII. for more information.
     CFR citation assigned in the regulatory text section of
these proposed rules.
    The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
    The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. EPA has initially
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that
certain changes from the conditions of use described in the PMNs could
result in changes in the type or form of exposure to the chemical
substances and/or increased exposures to the chemical substances and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substances. Consequently, EPA is proposing to designate
these changes as significant new uses.

PMN Number: P-16-192

    Chemical Name: Silanized amorphous silica (generic).
    CAS Number: Not available.
    Basis for action: The PMN states that the use of the substance will
be as a reinforcing filler for the production of rubber goods. Based on
test data for crystalline silica, EPA identified concerns for lung
effects if the chemical substance is not used following the limitations
noted below. The conditions of use of the PMN substance as described in
the PMN include the following protective measures:
    1. Manufacture of the PMN substance in an amorphous form.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the physical-chemical properties of the PMN substance
may be potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that information about the
physical form, particle size, and water solubility would help
characterize the potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11182.

PMN Numbers: P-16-354 and P-16-355

    Chemical name: Esteramine (generic).
    CAS number: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a chemical intermediate.
Based on the physical/chemical properties of the PMN substances and
Structure Analysis Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for irritation and
developmental/reproductive toxicity, and aquatic toxicity at surface
water concentrations exceeding 1 part per billion (ppb), if the
chemical substances are not used following the limitations noted below.
The conditions of use of the PMN substances as described in the PMNs
include the following protective measures:
    1. No release of a manufacturing, processing, or use stream
associated with any use of the substances, other than the confidential
chemical intermediate use described in the PMNs, into the waters of the
United States exceeding a surface water concentration of 1 ppb; and
    2. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the aquatic and human health toxicity of the PMN
substances may be potentially useful to characterize the health and
environmental effects of the PMN substances if a manufacturer or

processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific organ toxicity and aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substances.
    CFR citation: 40 CFR 721.11183.

PMN Numbers: P-16-380, P-16-381, P-16-382, P-16-383, P-16-384, and P-
16-385

    Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-381), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-382), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-384), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-385).
    CAS Numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a component of an
electrocoat resin. Based on the physical/chemical properties of the PMN
substances and test data on analogous substances, EPA has identified
concerns for lung effects and toxicity to aquatic organisms at
concentrations that exceed 16 ppb if the chemical substances are not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:
    1. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances; and
    2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 16 ppb.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substances may be potentially useful if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of specific target organ, pulmonary, and acute aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substances.
    CFR citation: 40 CFR 721.11184 (P-16-380); 40 CFR 721.11185 (P-16-
381); 40 CFR 721.11186 (P-16-382); 40 CFR 721.11187 (P-16-383); 40 CFR
721.11188 (P-16-384); and 40 CFR 721.11189 (P-16-385).

PMN Numbers: P-16-483 and P-16-484

    Chemical names: Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic) (P-16-483) and Inorganic acids, metal salts,
compds. with substituted aromatic heterocycle, (generic) (P-16-484).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of P-16-483 will be as a plastic additive and the
generic (non-confidential) use of P-16-484 will be as a chemical
intermediate. Based on test data submitted on P-16-483 and data for
analogous compounds, EPA has identified concerns for irritation,
specific organ effects, and aquatic toxicity if the chemical is not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:
    1. No use of the substances other than the confidential use
described in the PMNs;
    2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 34 ppb; and
    3. No manufacturing, processing or use of the PMN substances
without the engineering controls described in the PMNs to limit
exposure to dust.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substances may be potentially useful to characterize the effects of
the PMN substances if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of aquatic
toxicity and specific organ toxicity and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
PMN substances.
    CFR citations: 40 CFR 721.11190 (P-16-683) and 40 CFR 721.11191 (P-
16-684).

PMN Number: P-16-575

    Chemical name: Glucosyltransferase. International Union of
Biochemistry and Molecular Biology Number: <IP_ADDRESS>
    CAS number: 9032-14-8.
    Basis for action: The PMN states that the use of the substance will
be for polymerization of glucose. Based on the allergenic properties of
proteins and review of surrogate enzymatic protein data submitted, EPA
has identified concerns for respiratory sensitization if the chemical
is not used following the limitations noted below. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
    1. No manufacture, processing, or use of the PMN substance that
results in inhalation exposures to the substance.
    The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
    Potentially useful information: EPA has determined that certain
information about the workplace exposure to the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that

would be designated by this proposed SNUR. EPA has determined that the
results of workplace air monitoring would help characterize the
potential health effects of the PMN substance.
    CFR citation: 40 CFR 721.11192.

PMN Number: P-16-581

    Chemical name: Alpha 1,3-polysaccharide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance
will be as a polymer additive, paper coating component, composite
component, and fiber additive. Based on analogy to high molecular
weight polymers, EPA has identified concerns for lung effects if the
chemical is not used following the limitations noted below. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
    1. No use of the substance other than the uses described in the
PMN; and
    2. No manufacture, processing, or use with particle size less than
10 micrometers.
    The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
    Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health effects of the PMN substance if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has determined that the results of pulmonary effects toxicity testing
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance.
    CFR citation: 40 CFR 721.11193.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV, EPA identified certain reasonably foreseen changes from the
conditions of use identified in the PMNs and determined that those
changes could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances.

B. Objectives

    EPA is proposing SNURs for 13 specific chemical substances which
are undergoing premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses that would be designated in this proposed rule:
     EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
     EPA would be obligated to make a determination under TSCA
section 5(a)(3) regarding the use described in the SNUN, under the
conditions of use. The Agency will either determine under section
5(a)(3)(C) that the significant new use is not likely to present an
unreasonable risk, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use, or make a determination
under section 5(a)(3)(A) or (B) and take the required regulatory action
associated with the determination, before manufacture or processing for
the significant new use of the chemical substance can occur.
    Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed Rules 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 substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. 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
the chemical substances subject to this proposed SNUR, EPA concludes
that the proposed significant new uses are not ongoing.
    EPA designates October 10, 2018, as the cutoff date for determining
whether the new use is ongoing. The objective of EPA's approach is to
ensure that a person cannot defeat a SNUR by initiating a significant
new use before the effective date of the final rule.
    Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
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
EPA would have to take action under section 5 allowing manufacture or
processing to proceed.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
    In the absence of a rule, order, or consent agreement under TSCA
section 4 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
Sec.  720.50). However, upon review of PMNs and SNUNs, the Agency has
the authority to require appropriate testing. Unit IV. lists
potentially useful information for all SNURs listed here. Descriptions
are provided for informational purposes. The potentially useful
information identified in Unit IV. will be useful to EPA's evaluation
in the event that someone submits a SNUN for the significant new use.
Companies who are considering submitting a SNUN are encouraged, but not
required, to develop the information on the substance, which may assist
with EPA's analysis of the SNUN.
    EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the

data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). 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 which provide detailed information on the following:
     Human exposure and environmental release that may result
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

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 Sec.  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 Sec.  720.40 and Sec.  721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. 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. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2017-0575.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for 13 new chemical
substances that were the subject of PMNs. 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 action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does 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. 605(b)), 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 SNUN submitted by any small entity would not cost
significantly more than $9,816.
    A copy of that certification is available in the docket for this
action.
    This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. 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 $9.816.
    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 will be impacted by this proposed
rule. As such, EPA has determined that this proposed rule does 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. 1502, 1503, 1504, or 1505
et seq.).

E. Executive Order 13132

    This action 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 does 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 action 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 action 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 action is not expected to affect energy supply,
distribution, or use and because this action is not a significant
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA Sec.  12(d) (Pub. L. 104-113, 12(d)), does not apply
to this action.

J. Executive Order 12898

    This action 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: October 5, 2018.
Tala R. Henry,
Acting Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 is 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.  721.11182 to subpart E to read as follows:

Sec.  721.11182  Silanized amorphous silica (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as silanized
amorphous silica (P-16-192) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture the substance other than in an amorphous form.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
3. Add Sec.  721.11183 to subpart E to read as follows:

Sec.  721.11183  Esteramine (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substances identified generically as esteramine
(PMN P-16-354 and P-16-355) are 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substances in any manner that results
in inhalation exposure. It is a significant new use to release a
manufacturing, processing, or use stream associated with any use of the
substances, other than the confidential chemical intermediate use
described in the premanufacture notices, into the waters of the United
States exceeding a surface water concentration of 1 part per billion
(ppb) using the methods described in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) though (e), and (i) are applicable to manufacturers and
processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
4. Add Sec.  721.11184 to subpart E to read as follows:

Sec.  721.11184   Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic)

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (P-16-380) 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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
5. Add Sec.  721.11185 to subpart E to read as follows:

Sec.  721.11185  Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically as propanoic acid, 2-
hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
formates (salts), (P-16-381) 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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.

    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
6. Add Sec.  721.11186 to subpart E to read as follows:

Sec.  721.11186  Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products sulfamates (salts), (generic),

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (P-16-382)
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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
7. Add Sec.  721.11187 to subpart E to read as follows:

Sec.  721.11187  Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products acetates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (P-16-383) 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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
8. Add Sec.  721.11188 to subpart E to read as follows:

Sec.  721.11188  Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as propanoic
acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino] ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
formates (salts), (P-16-384) 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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
9. Add Sec.  721.11189 to subpart E to read as follows:

Sec.  721.11189  Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products sulfamates (salts), (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (P-16-385)
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) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are

applicable to manufacturers, importers, and processors of this
substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
0
10. Add Sec.  721.11190 to subpart E to read as follows:

Sec.  721.11190  Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
inorganic acids, metal salts, compds. with modified heteroaromatics,
(PMN P-16-483) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the premanufacture notice to limit exposure to
dust.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 34 ppb.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), 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)(i) of
this section.
0
11. Add Sec.  721.11191 to subpart E to read as follows:

Sec.  721.11191  Inorganic acids, metal salts, compds. with substituted
aromatic heterocycle, (generic).

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance identified generically as inorganic
acids, metal salts, compds. with substituted aromatic heterocycle, (PMN
P-16-484) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the premanufacture to limit exposure to dust.
    (ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 34.
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), 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)(i) of
this section.
0
12. Add Sec.  721.11192 to subpart E to read as follows:

Sec.  721.11192  Glucosyltransferase, International Union of
Biochemistry and Molecular Biology Number: <IP_ADDRESS>.

    (a) Chemical substance and significant new uses subject to
reporting.
    (1) The chemical substance identified as glucosyltransferase,
International Union of Biochemistry and Molecular Biology Number:
<IP_ADDRESS> (PMN P-16-575, CAS No. 9032-14-8) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(y)(1) and (y)(2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) 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.
0
13. Add Sec.  721.11193 to subpart E to read as follows:

Sec.  721.11193  Alpha 1,3-polysaccharide (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alpha
1,3-polysaccharide (generic) (PMN P-16-581) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80. It is a significant new use to use the
substance other than as a polymer additive, paper coating component,
composite component, or fiber additive. It is a significant new use to
manufacture, process or use the PMN substance with particle size less
than 10 micrometers.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) 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.

[FR Doc. 2018-22397 Filed 10-15-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26310-26313]
[FR Doc No: 2015-10946]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74858; File No. SR-MSRB-2015-04]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Consisting of the Specifications for the Selection of
Examination Questions and Content Outline for the Municipal Advisor
Representative Qualification Examination

May 1, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 22, 2015, the Municipal Securities Rulemaking Board (the
``MSRB'' or ``Board'') filed with the Securities and Exchange
Commission (the ``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the MSRB. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The MSRB filed with the Commission the specifications for the
selection of examination questions (``selection specifications'') and
content outline for the Municipal Advisor Representative Qualification
Examination (``Series 50 examination'') (the ``proposed rule
change'').\3\ The MSRB is not proposing in this filing any textual
changes to its rules.
---------------------------------------------------------------------------

    \3\ The MSRB is also proposing the question bank for the Series
50, but based upon instructions from the Commission staff, the MSRB
is submitting SR-MSRB-2015-04 for immediate effectiveness pursuant
to Section 19(b)(3)(A)(i) of the Act and Rule 19b-4(f)(6)
thereunder, and is not filing the question bank for Commission
review. See letter to Diane G. Klinke, General Counsel, MSRB, from
Belinda Blaine, Associate Director, Division of Market Regulation,
SEC, dated July 24, 2000, attached as Exhibit 3b. The question bank
is available for Commission review. The selection specifications for
the Series 50 examination, Exhibit 3c, have been omitted and filed
separately with the Commission for confidential treatment pursuant
to Rule 24b-2 of the Securities Exchange Act.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the MSRB's Web
site at www.msrb.org/Rules-and-Interpretations/SEC-Filings/2015-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Section 15B of the Act requires the MSRB to establish professional
standards for municipal advisors.\4\ The Act further requires
associated persons of municipal advisors to pass such examinations as
the Board may establish to demonstrate that such individuals meet the
standards as the Board finds necessary or appropriate in the public
interest or for the protection of investors and municipal entities or
obligated persons.\5\ A professional qualification examination is
intended to determine whether an individual meets the MSRB's basic
qualification standards for a particular registration category. The
examination measures a candidate's knowledge of the business
activities, as well as the regulatory requirements, including MSRB
rules, SEC rules, rule interpretations and other federal law,
applicable to a particular registration category.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78o-4(b)(2)(L)(iii).
    \5\ See Section 15B(b)(2)(A)(iii) of the Act, 15 U.S.C. 78o-
4(b)(2)(A)(iii).
---------------------------------------------------------------------------

    On February 26, 2015, the Commission approved amendments to MSRB
Rule G-3, which established the qualification examination requirements
for municipal advisor representative and municipal advisor principal
candidates.\6\ Individuals who engage in municipal advisory activities
must qualify as municipal advisor representatives and individuals who
engage in the management, direction or supervision of the municipal
advisory activities of municipal advisors and their associated persons
must qualify as municipal advisor principals. To qualify as either a
municipal advisor representative or municipal advisor principal, an
individual must pass the Series 50 examination. The examination
requirement in MSRB Rule G-3(d) is intended, among other things, to
increase municipal advisor representative and municipal advisor
principal candidates' awareness and knowledge that they are operating
in a regulated environment designed to protect municipal entities,
obligated persons and the integrity of the municipal market.
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    \6\ See Exchange Act Release No. 74384 (Feb. 26, 2015), 80 FR
11706 (Mar. 4, 2015), File No. SR-MSRB-2014-08.
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    The MSRB developed the Series 50 examination content outline in
accordance with The Standards for Educational and Psychological Testing
(``APA Standard''),\7\ including the engagement of a psychometrician
and a committee of industry subject matter experts. The Series 50
examination content outline has been developed to provide reasonable
assurance that municipal advisor representative candidates understand
their professional responsibilities, including key regulatory
requirements and duties and obligations. The examination will test
applicants on their general knowledge of the municipal advisory
industry and the associated municipal advisor regulatory framework.\8\
To develop the examination to fulfill these purposes, the MSRB in July
of 2014 completed a job analysis of municipal advisors based on a web-
based survey that was sent to all MSRB-registered municipal
advisors.\9\ The MSRB received 565 responses to the survey from
individuals who engage in a variety of municipal advisory activities
for different-sized firms in different areas of the country. The survey
results provided the MSRB with certain data on municipal advisors, such
as the duties, tasks, and responsibilities performed by individuals who
engage in various municipal advisory activities and the level of
knowledge an individual should possess to be sufficiently qualified to
perform municipal advisory activities. The job analysis, coupled with
focus panels, provided the empirical basis for the representation of
topic areas on the Series 50 examination.
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    \7\ See American Educational Research Association, American
Psychological Association, & National Council on Measurement in
Education, The Standards for Educational and Psychological Testing
(2d ed. 2014).
    \8\ See Series 50 examination content outline attached hereto as
Exhibit 3a.
    \9\ A job analysis is an assessment of the essential skills and
functions that are required to complete a particular job.
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    The Series 50 examination will consist of 100 multiple-choice
questions. Candidates are allowed 180 minutes to complete the
examination.\10\ Consistent with other financial regulatory
qualification examinations, candidates may receive (at the option of
their firm) an informational breakdown of their performance on each
section of the examination and their pass/fail status at the completion
of the testing session. As provided for in MSRB Rule G-3(g) and
consistent with other MSRB examinations, candidates that fail to pass
the Series 50 examination are permitted to take the examination again
after a period of 30 days has elapsed from the date of the prior
examination. Any person, however, who fails to pass the Series 50
examination three or more times in succession is prohibited from taking
the Series 50 examination again until six months has elapsed from the
date the candidate last failed the examination.
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    \10\ Prior to beginning the examination, candidates will receive
a tutorial on how to complete the computerized examination.
Candidates will be given 30 minutes to complete the tutorial in
addition to the 180 minutes allowed to complete the examination.
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    The Series 50 examination content outline has been developed to
assist municipal advisor representative candidates in preparing for the
Series 50 examination and will be available on the MSRB's Web site. The
Series 50 examination content outline describes the following five
topical sections comprising the examination: (1) Understanding SEC and
MSRB Rules Regarding Municipal Advisors (12 questions); (2)
Understanding Municipal Finance (35 questions); (3) Performing Issuer's
Credit Analysis and Due Diligence (12 questions); (4) Structuring,
Pricing and Executing Municipal Debt Products (31 questions); and (5)
Understanding Requirements Related to the Issuance of Municipal Debt
(10 questions).
    The reference materials section of the Series 50 examination
content outline is intended to provide candidates with a list of
resources, which when used in conjunction with the Series 50
examination content outline, can assist candidates in preparing for the
Series 50 examination. The reference materials were recommended by
municipal advisors as having been helpful resources in carrying out the
job functions of a municipal advisor. The reference materials are not
intended to be all-inclusive, nor are the reference materials intended
to specifically represent content that may be covered on the
examination.
    Prior to announcing the effective date of the Series 50
examination, the MSRB will conduct a pilot for the Series 50
examination. The Series 50 pilot examination will assist the MSRB in
validating the bank of examination questions and establishing the
passing score. The Series 50 pilot examination will consist of 120-125
questions. Candidates will have 240 minutes to complete the Series 50
pilot examination.\11\ The Series 50 pilot examination will be
available for a limited time this fall and open to all municipal
advisor representative and municipal advisor principal candidates.
Those candidates who take and pass the

Series 50 pilot examination will have the municipal advisor
representative qualification and will not be required to take the
permanent Series 50 examination.\12\ The MSRB will notify candidates
who take the Series 50 pilot examination of their results approximately
three months after taking the examination. The MSRB will announce the
dates and the registration process for the Series 50 pilot examination
in a notice published on the MSRB's Web site no later than three months
from the date of this filing and with at least thirty days advance
notice.\13\ The MSRB will announce an effective date for the permanent
Series 50 examination in a notice published on the MSRB's Web site no
later than one year from the date of this filing and with at least 60
days advance notice.\14\
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    \11\ Prior to beginning the pilot examination, candidates will
receive a tutorial on how to complete the computerized examination.
Candidates will be given 30 minutes to complete the tutorial in
addition to the 240 minutes allowed to complete the examination.
    \12\ An individual who fails to pass the Series 50 pilot
examination will, consistent with MSRB Rule G-3(g), still be allowed
three attempts to pass the permanent Series 50 examination before
having to wait a period of 6 months to take the permanent Series 50
examination again.
    \13\ For the most up-to-date information on the Series 50 pilot
examination visit the Municipal Advisor Professional Qualifications
page on the MSRB's Web site.
    \14\ To provide for an orderly transition to the new examination
requirement for municipal advisor representatives and municipal
advisor principals, the MSRB will allow municipal advisor
professionals one year from the announced effective date of the
Series 50 examination to pass the examination. This one-year grace
period is intended to provide municipal advisor representatives and
municipal advisor principals with sufficient time to study for and
take the examination without causing undue business disruption.
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    The selection specifications for the Series 50 examination, which
the MSRB has submitted under separate cover with a request for
confidential treatment to the Commission's Secretary pursuant to Rule
24b-2 under the Act,\15\ describe additional confidential information
regarding the Series 50 examination.
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    \15\ 17 CFR 240.24b-2.
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2. Statutory Basis
    Section 15B(b)(2)(A) of the Act authorizes the MSRB to prescribe
standards of training, experience, competence, and such other
qualifications for associated persons of municipal advisors as the
Board finds necessary or appropriate in the public interest or for the
protection of investors and municipal entities or obligated
persons.\16\ Section 15B(b)(2)(A)(i)-(iii) of the Act also provides
that the Board may appropriately classify municipal advisors and
persons associated with municipal advisors and require persons in any
such class to pass tests prescribed by the Board.\17\
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    \16\ 15 U.S.C. 78o-4(b)(2)(A).
    \17\ 15 U.S.C. 78o-4(b)(2)(A)(i)-(iii).
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    The MSRB believes that the Series 50 examination content outline
for the Series 50 examination is consistent with the provisions of
Section 15B(b)(2)(A) of the Act in that the Series 50 examination
content outline is designed to ensure that individuals are sufficiently
qualified to perform municipal advisory activities.

B. Self-Regulatory Organization's Statement on Burden on Competition

    Section 15B(b)(2)(C) of the Act \18\ requires that MSRB rules not
be designed to impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. In addition,
Section 15B(b)(2)(L)(iv) of the Act provides that MSRB rules may ``not
impose a regulatory burden on small municipal advisors that is not
necessary or appropriate in the public interest and for the protection
of investors, municipal entities, and obligated persons, provided that
there is robust protection of investors against fraud.'' \19\
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    \18\ 15 U.S.C. 78o-4(b)(2)(C).
    \19\ 15 U.S.C. 78o-4(b)(2)(L)(iv).
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    In considering these standards, the MSRB was guided by the Board's
Policy on the Use of Economic Analysis.
    The MSRB does not believe that the Series 50 examination content
outline will impose any burdens that are not necessary or appropriate
in furtherance of the purposes of the Act.
Need for Rule
    The Dodd-Frank Wall Street Reform and Consumer Protection Act of
2010 (``Dodd-Frank Act'') amended Section 15B of the Exchange Act to
provide for the regulation by the SEC and the MSRB of municipal
advisors and to grant the MSRB certain authority to protect municipal
entities and obligated persons.\20\ The Dodd-Frank Act's legislative
history indicates Congress was concerned that ``[d]uring the
[financial] crisis, a number of municipalities suffered losses from
complex derivatives products that were marketed by unregulated
financial intermediaries.'' \21\
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    \20\ Public Law 111-203, 124 Stat. 1376 (2010).
    \21\ S. Rep. No. 111-176, at 38 (2010).
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Baseline
    The economic baseline for the Series 50 examination content outline
includes the Dodd-Frank Act which established the federal regulatory
framework for municipal advisors, required the MSRB to establish
standards of training, experience, competence and other qualifications
for municipal advisors and their associated persons, and required
associated persons of municipal advisors to pass examinations to
demonstrate that they meet the standards the Board finds necessary or
appropriate in the public interest or for the protection of investors,
and municipal entities or obligated persons.\22\ The baseline also
includes MSRB Rule G-3(d), which established the municipal advisor
representative qualification examination requirement for municipal
advisor representative candidates.\23\
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    \22\ See Section 15B(b)(2)(A) of the Act, 15 U.S.C. 78o-
4(b)(2)(A).
    \23\ See supra note 6.
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Alternatives
    The MSRB developed the Series 50 examination content outline in
accordance with The Standards for Educational and Psychological Testing
(``APA Standard''),\24\ including the engagement of a psychometrician
and a committee of industry subject matter experts, as is consistent
with the development of other financial industry qualification
examinations. This process resulted in the identification and
consideration of a range of alternatives. Decisions about which
alternatives to select for the final Series 50 examination content
outline were made consistent with the APA Standard.
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    \24\ See supra note 7.
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Economic Impact
    Relative to the economic baseline, which includes the requirement
that municipal advisors demonstrate by passing an examination that they
meet standards deemed necessary or appropriate in the public interest
or for the protection of investors, municipal entities and obligated
persons, the MSRB believes that the economic impact of the Series 50
examination content outline is de minimis and no greater than what is
necessary or appropriate in furtherance of the purposes of the Act.\25\
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    \25\ As noted above, many of the costs and burdens, including
impacts on competition, associated with the Series 50 examination
content outline are accounted for in the baseline which is made up,
in part, by the Dodd-Frank Act. In 2013, the SEC concluded that the
municipal advisory services market was competitive and not highly
concentrated under a similar baseline. See Registration of Municipal
Advisors, Exchange Act Release No. 70462 (Sept. 20, 2013), 78 FR
67608 at n.1723 (Nov. 12, 2013).
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    While any examination intended to identify those individuals who
meet a particular standard of competence may represent a barrier to
entry, the MSRB believes that the standard that successful completion
of the examination will demonstrate is necessary to protect investors
and

municipal entities or obligated persons and will help ensure that those
offering municipal advisory service do so on a level playing field. As
such, the MSRB believes that the Series 50 examination content outline
poses no burden on competition that is not necessary or appropriate in
furtherance of the Act and may enhance the competiveness of the market.
    Based on the well-established and nationally-accepted process used
by the MSRB to develop the Series 50 examination content outline, the
MSRB has no reason to believe that the Series 50 examination content
outline will pose any greater burden on individuals associated with
smaller firms than those associated with larger firms or that the
burden could be materially reduced while still achieving the purposes
of the Act. While it is possible that small municipal advisors may have
access to fewer resources to prepare for this examination, the MSRB
does not believe this will affect the competitiveness of the market.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Pursuant to Section 19(b)(3)(A) \26\ of the Act and Rule 19b-
4(f)(6) \27\ thereunder, the MSRB has designated the proposed rule
change as one that effects a change that: (i) Does not significantly
affect the protection of investors or the public interest; (ii) does
not impose any significant burden on competition; and (iii) by its
terms, does not become operative for 30 days after the date of the
filing, or such shorter time as the Commission may designate.
---------------------------------------------------------------------------

    \26\ 15 U.S.C. 78s(b)(3)(A).
    \27\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative until 30 days after the date of filing.\28\
However, Rule 19b-4(f)(6)(iii) \29\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest.\30\ The MSRB has requested that the
Commission designate the proposed rule change operative upon
filing,\31\ as specified in Rule 19b-4(f)(6)(iii),\32\ which would make
the proposed rule change operative on April 22, 2015. The MSRB has
stated that an earlier operative date would provide municipal advisor
professionals with an earlier opportunity to begin preparation for the
qualification requirement.\33\
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    \28\ Id.
    \29\ 17 CFR 240.19b-4(f)(6)(iii).
    \30\ In addition, Rule 19b-4(f)(6)(iii) requires a self-
regulatory organization to give the Commission written notice of its
intent to file a proposed rule change, along with a brief
description and text of such proposed rule change, at least five
business days prior to the date of filing, or such shorter time as
designated by the Commission. The MSRB satisfied this requirement on
April 14, 2015.
    \31\ See SR-MSRB-2015-04.
    \32\ 17 CFR 240.19b-4(f)(6)(iii).
    \33\ See supra note 31.
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    The Commission hereby grants the MSRB's request and believes that
designating the proposed rule change operative upon filing is
consistent with the protection of investors and the public
interest.\34\ According to the MSRB, the Series 50 examination content
outline is designed to ensure that individuals are sufficiently
qualified to perform municipal advisory activities.\35\ The Commission
believes that designating the proposed rule change operative upon
filing is consistent with the protection of investors and the public
interest because it will allow individuals to prepare for the Series 50
examination without delay. In addition, the proposed rule change is not
proposing any textual changes to MSRB rules. Therefore, the Commission
hereby designates the proposed rule change operative upon filing.
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    \34\ For the purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule
change's impact on efficiency, competition, and capital formation.
See 15 U.S.C. 78c(f).
    \35\ See supra note 31.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2015-04 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

All submissions should refer to File Number SR-MSRB-2015-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the MSRB. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MSRB-2015-04 and should be
submitted on or before May 28, 2015.

    For the Commission, pursuant to delegated authority.\36\
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    \36\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-10946 Filed 5-6-15; 8:45 am]
 BILLING CODE 8011-01-P