Document ID: EPA-HQ-OPPT-2017-0575-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2018-10-16T04:00Z

[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Proposed Rules]
[Pages 52179-52187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 52180]]

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: (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 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

[[Page 52181]]

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

[[Page 52182]]

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: 2.4.1.5
    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

[[Page 52183]]

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

[[Page 52184]]

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.

[[Page 52185]]

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.

[[Page 52186]]

    (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

[[Page 52187]]

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: 2.4.1.5.

    (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: 
2.4.1.5 (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