[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66599-66612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26224]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0697; FRL-10002-30]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (18-4)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for chemical substances that are 
the subject of premanufacture notices (PMNs), and TSCA Orders. The 
SNURs require persons who intend to manufacture (defined by statute to 
include import) or process any of these chemical substances for an 
activity that is designated as a significant new use by this rule to 
notify EPA at least 90 days before commencing that activity. Persons 
may not commence manufacture or processing for the significant new use 
until EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and has taken such actions as are required 
by that determination.

DATES: This rule is effective on February 3, 2020. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
December 19, 2019.

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 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 SNURs must certify 
compliance with the SNUR requirements. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after January 6, 2020 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

B. How can I access the docket?

    The docket includes information considered by the Agency in 
developing the proposed and final rules. The docket for this action, 
identified by the docket identification (ID) number listed at the top 
of this document, is available at http://www.regulations.gov or at the 
Office of Pollution Prevention and

[[Page 66600]]

Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW, Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is finalizing these SNURs under TSCA section 5(a)(2) for 29 
chemical substances that are the subject of PMNs. These SNURs 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.
    In the Federal Register of March 19, 2019 (84 FR 99996) (FRL-9986-
83), EPA proposed a SNUR for these chemical substances in 40 CFR part 
721, subpart E. More information on the specific chemical substances 
subject to this final rule can be found in the Federal Register 
documents for the proposed rule.
    The record for the SNUR was established in the docket under docket 
ID number EPA-HQ-OPPT-2018-0697. That docket includes information 
considered by the Agency in developing the proposed and final rules, 
public comments submitted for the rule, and EPA's responses to public 
comments received on the proposed rule.

B. What is the Agency's authority for taking this action?

    TSCA section 5(a)(2) (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 TSCA section 5(a)(2) factors 
listed in Unit III. Once EPA determines that a use of a chemical 
substance is a significant new use, TSCA section 5(a)(1)(B) requires 
persons to submit a significant new use notice (SNUN) to EPA at least 
90 days before they manufacture or process the chemical substance for 
that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such 
manufacturing or processing from commencing until EPA has conducted a 
review of the notice, made an appropriate determination, and taken such 
actions as are required in association with that determination (15 
U.S.C. 2604(a)(1)(B)(ii)). In the case of a determination other than 
not likely to present unreasonable risk, the applicable review period 
must also expire before manufacturing or processing for the new use may 
commence.

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. According 
to 40 CFR 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). These requirements include the 
information submission requirements of TSCA sections 5(b) and 5(d)(1), 
the exemptions authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA must either determine that the use is not likely to present 
an unreasonable risk of injury under the conditions of use for the 
chemical substance or take such regulatory action as is associated with 
an alternative determination before the manufacture or processing for 
the significant new use can commence. In the case of a determination 
other than not likely to present unreasonable risk, the applicable 
review period must also expire before manufacturing or processing for 
the new use may commence. If EPA determines that the 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

    When the Agency issues an Order under TSCA section 5(e), TSCA 
section 5(f)(4) requires that the Agency consider whether to promulgate 
a SNUR for any use not conforming to the restrictions of the Order or 
publish a statement describing the reasons for not initiating the 
rulemaking. TSCA section 5(a)(2) 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 determining what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four TSCA section 5(a)(2) factors listed in this 
unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from seven entities on the proposed 
rule. The Agency's responses are described in a separate Response to 
Public Comments document contained in the public docket for this rule, 
EPA-HQ-OPPT-2018-0697. As described in the Response to Public Comments 
document, EPA is finalizing the SNURs as proposed, as the only changes 
were correcting some CFR citations in the regulatory text.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for these chemical substances in 40 CFR part 721, subpart 
E. In Unit IV. of the proposed rule (84 FR 9999; March 19, 2019), 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 TSCA section 5(e) Order.
     Potentially Useful Information. This is information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the chemical substance in support of a 
request by the PMN submitter to modify the TSCA Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by the SNUR.

[[Page 66601]]

     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of each rule specifies the activities 
designated as significant new uses. Certain new uses, including 
exceedance of production volume limits (i.e., limits on manufacture 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    These PMN chemical substances are subject to Orders under TSCA 
section 5(e)(1)(A)(ii)(I) where EPA determined that activities 
associated with the PMN substances may present unreasonable risk to 
human health or the environment. Those Orders require protective 
measures to limit exposures or otherwise mitigate the potential 
unreasonable risk. The SNURs identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order usually requires that 
potentially exposed employees wear specified respirators unless actual 
measurements of the workplace air show that air-borne concentrations of 
the PMN substance are below the New Chemical Exposure Limit (NCEL). The 
comprehensive NCELs provisions in TSCA section 5(e) Orders include 
requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. No comparable NCEL provisions currently exist in 40 CFR 
part 721, subpart B, for SNURs. Therefore, for these cases, the 
individual SNURs in 40 CFR part 721, subpart E, will state that persons 
subject to the SNUR who wish to pursue NCELs as an alternative to the 
40 CFR 721.63 respirator requirements may request to do so under 40 CFR 
721.30. EPA expects that persons whose 40 CFR 721.30 requests to use 
the NCELs approach for SNURs that are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA section 5(e) Order.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that regulation was 
warranted under TSCA section 5(e), pending the development of 
information sufficient to make reasoned evaluations of the health or 
environmental effects of the chemical substances. The basis for such 
findings is outlined in Unit IV. Based on these findings, TSCA section 
5(e) Orders requiring the use of appropriate exposure controls were 
negotiated with the PMN submitters. As a general matter, EPA believes 
it is necessary to follow TSCA section 5(e) Orders with a SNUR that 
identifies the absence of those protective measures as Significant New 
Uses to ensure that all manufacturers and processors--not just the 
original submitter--are held to the same standard.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To identify as significant new uses any manufacturing, 
processing, use, distribution in commerce, or disposal that does not 
conform to the restrictions imposed by the underlying Orders, 
consistent with TSCA section 5(f)(4).
     To receive notice of any person's intent to manufacture or 
process a listed chemical substance for the described significant new 
use before that activity begins.
     To 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.
     To be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) Orders have been issued 
for all the chemical substances, and the PMN submitters are prohibited 
by the TSCA section 5(e) Orders from undertaking activities which will 
be designated as significant new uses. The identities of 23 of the 29 
chemical substances subject to this rule have been claimed as 
confidential. Based on this, the Agency believes that it is highly 
unlikely that any of the significant new uses described in the 
regulatory text of this rule are ongoing.
    Furthermore, EPA designated August 27, 2018 (the date of public 
release of the original direct final and proposed rules) as the cutoff 
date for determining whether the new use is ongoing. The objective of 
EPA's approach has been to ensure that a person could not defeat a SNUR 
by initiating a significant new use before the effective date of the 
final rule.
    In the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of August 27, 2018, that person will have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons will have to first comply with all 
applicable SNUR notification requirements and wait until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: 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

[[Page 66602]]

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 (40 CFR 720.50). 
However, upon review of PMNs and SNUNs, the Agency has the authority to 
require appropriate testing, under 40 CFR part 721, subpart E. In Unit 
IV. of the original proposed rule (84 FR 9999; March 19, 2019), lists 
potentially useful information to EPA's evaluation.
    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. 
Furthermore, pursuant to TSCA section 4(h), which pertains to reduction 
of testing on 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).
    In some of the TSCA section 5(e) Orders for the chemical substances 
regulated under this rule, EPA has established production volume 
limits. These limits cannot be exceeded unless the PMN submitter 
submits the results of specified tests. The SNURs contain the same 
production volume limits as the TSCA section 5(e) Orders. Exceeding 
these production limits is defined as a significant new use. Persons 
who intend to exceed the production limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture or processing.
    Any request by EPA for the triggered and pended testing described 
in the TSCA Orders 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 PMN substances. Further, any such testing 
request on the part of 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.
    The potentially useful information identified in Unit IV. of the 
original proposed rule may not be the only means of addressing the 
potential risks of the chemical substance. However, submitting a SNUN 
without any test data or other information may increase the likelihood 
that EPA will take action under TSCA sections 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 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.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in 40 CFR 
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 40 CFR 721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2018-0697.

XII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulations and Regulatory Review

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs and TSCA section 5(e) Orders. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 
13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    According to the 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 the PRA, 
unless it has been approved by OMB and displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations in title 
40 of the CFR, after appearing in the

[[Page 66603]]

Federal Register, are listed in 40 CFR part 9, and included on the 
related collection instrument or form, if applicable. EPA is amending 
the table in 40 CFR part 9 to list the OMB approval number for the 
information collection requirements contained in this action. This 
listing of the OMB control numbers and their subsequent codification in 
the CFR satisfies the display requirements of PRA and OMB's 
implementing regulations at 5 CFR part 1320. This Information 
Collection Request (ICR) was previously subject to public notice and 
comment prior to OMB approval, and given the technical nature of the 
table, EPA finds that further notice and comment to amend it is 
unnecessary. As a result, EPA finds that there is ``good cause'' under 
section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) to amend this table without further notice and comment.
    The information collection activities in this action have already 
been approved by OMB pursuant to the 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 using 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (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)

    Pursuant to RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency 
hereby certifies that promulgation of this SNUR will not have a 
significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. EPA's experience to date is that, in response to the 
promulgation of SNURs covering over 1,000 chemicals, the Agency 
receives only a small number of notices per year. For example, the 
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 
and only a fraction of these were from small businesses. In addition, 
the Agency currently offers relief to qualifying small businesses by 
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee 
reduces the total reporting and recordkeeping of cost of submitting a 
SNUN to about $10,116 for qualifying small firms. Therefore, the 
potential economic impacts of complying with this SNUR are not expected 
to be significant or adversely impact a substantial number of small 
entities. In a SNUR that published in the Federal Register of June 2, 
1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general 
determination that final SNURs are not expected to have a significant 
economic impact on a substantial number of small entities, which was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

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 action. As 
such, EPA has determined that this action 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. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action does 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 (65 FR 67249, November 9, 2000), do not apply 
to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (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: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use 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 section 12(d) (15 U.S.C. 272 note) does not apply to 
this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

XIII. Congressional Review Act (CRA)

    Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of the rule in the Federal 
Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

[[Page 66604]]

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: November 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority:  7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.


0
2. In Sec.  9.1, add entries for Sec. Sec.  721.11221 through 721.11246 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.11221...............................................       2070-0012
721.11222...............................................       2070-0012
721.11223...............................................       2070-0012
721.11224...............................................       2070-0012
721.11225...............................................       2070-0012
721.11226...............................................       2070-0012
721.11227...............................................       2070-0012
721.11228...............................................       2070-0012
721.11229...............................................       2070-0012
721.11230...............................................       2070-0012
721.11231...............................................       2070-0012
721.11232...............................................       2070-0012
721.11233...............................................       2070-0012
721.11234...............................................       2070-0012
721.11235...............................................       2070-0012
721.11236...............................................       2070-0012
721.11237...............................................       2070-0012
721.11238...............................................       2070-0012
721.11239...............................................       2070-0012
721.11240...............................................       2070-0012
721.11241...............................................       2070-0012
721.11242...............................................       2070-0012
721.11243...............................................       2070-0012
721.11244...............................................       2070-0012
721.11245...............................................       2070-0012
721.11246...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec. Sec.  721.11221 through 721.11246 to subpart E to read as 
follows:

Subpart E Significant New Uses for Specific Chemical Substances

Sec.
* * * * *
721.11221 Fatty acids, C16 and C18-unsatd., Me esters, chlorinated.
721.11222 Chlorinated complex esters (generic).
721.11223 Sodium branched chain alkyl hydroxyl and branched chain 
alkenyl sulfonates (generic).
721.11224 Spiro tetrafluoroborate (generic).
721.11225 2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.
721.11226 2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-
methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride (1:1).
721.11227 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.
721.11228 Aliphatic polyamines, polymers with bisphenol A and 
epichlorohydrin (generic).
721.11229 Epoxy-amine adduct, methanesulfonates (generic).
721.11230 Modified ethylene-vinyl alcohol copolymer (generic).
721.11231 Cashew, nutshell liq., polymer with acid and halohydrin 
(generic).
721.11232 Pentaerythritol ester of mixed linear and branched 
carboxylic acids (generic).
721.11233 Cashew nut shell liquid, branched polyester-polyether 
polyol (generic).
721.11234 Methylene diphenyl diisocyanate terminated polyurethane 
resin (generic).
721.11235 2-Furancarboxylic acid, tetrahydro-.
721.11236 Heteromonocycle, homopolymer, alkyl substituted carbamate, 
alkyl ester (generic).
721.11237 Polysiloxanes, di alkyl, substituted alkyl group 
terminated, alkoxylated, reaction products with alkanoic acid, 
isocyanate substituted-alkyl carbomonocycle and polyol (generic).
721.11238 Substituted carbomonocycle, polymer with substituted 
heteromonocycle and substituted polyalkylene glycol (generic).
721.11239 Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid, 
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl 
substituted carbomonocycle and alkyl substituted alkanediol 
(generic).
721.11240 Substituted carbomonocycle, polymer with 
diisocyanatoalkane, substituted alkylacrylate blocked (generic).
721.11241 1,2-Ethanediol, 1,2-dibenzoate.
721.11242 Alkenoic acid, reaction products with 
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with 
isocyanatoalkane and substituted alkanoic acid, substituted 
monoacrylate alkanoate-blocked (generic).
721.11243 Aromatic dicarboxylic acid, compound with alkane diamines, 
polymer with alkane diamine and dicarboxylic acid (generic).
721.11244 Aromatic dicarboxylic acid, compound with alkyl diamines, 
homopolymer (generic).
721.11245 Aspartic acid, tallow modified diester (generic).
721.11246 Substituted alkanediol, polymer with heteromonocycles, 
alkenoate, metal complexes (generic).
* * * * *


Sec.  721.11221  Fatty acids, C16 and C18-unsatd., Me esters, 
chlorinated.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as fatty acids, C16 
and C18-unsatd., Me esters, chlorinated (PMN P-15-353, CAS No. 1642303-
17-0) 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(k). It is a significant new use to 
manufacture the substance beyond three years.
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions

[[Page 66605]]

of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.


Sec.  721.11222  Chlorinated complex esters (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
chlorinated complex esters (PMN P-15-433) 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(k). It is a significant new use to 
manufacture the substance beyond three years.
    (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.
    (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.


Sec.  721.11223  Sodium branched chain alkyl hydroxyl and branched 
chain alkenyl sulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as sodium 
branched chain alkyl hydroxyl and branched chain alkenyl sulfonates 
(PMN P-16-186) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iv), (3), (6)(v) and (vi) (particulate), (b) 
(concentration set at 1.0%), and (c). When determining which persons 
are reasonable likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposures, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii) and (ix) (eye irritation), (2)(i) and (v) (eye protection), (4)(i) 
through (iii), and (5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process or use of the substance in a manner that results 
in inhalation exposure to vapor, dust, spray, mist, or aerosol.
    (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 (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 significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  721.11224  Spiro tetrafluoroborate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as spiro 
tetrafluoroborate (PMN P-16-207) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) through (5) and (6) (particulate), (b)(concentration set 
at 1.0%), and (c). When determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(1) and (4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposures, where feasible. For Sec.  
721.63(a)(5), respirators must provide a NIOSH assigned protection 
factor of at least 1000.
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 0.2 mg/m\3\ as 
an 8-hour time-weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved]
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv) and 
(ix), (2)(i) through (iv) and (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used. For Sec.  
721.72(g)(2)(iv), use respiratory protection, or maintain workplace 
airborne concentrations at or below an 8-hour time-weighted average of 
0.2 mg/m\3\.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (q).
    (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 (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  721.11225  2-Pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-
methoxyphenyl)-4,5-difluoro-, phenylmethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-methoxyphenyl)-4,5-
difluoro-, phenylmethyl ester (PMN P-16-246, CAS No. 1391033-38-7) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iv), (3) through (6)(i) and (ii), (v) and 
(vi), (b) (concentration set at 0.1%), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the

[[Page 66606]]

operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) and 
(ii), (iv), (vi), (vii) and (ix), (2)(i) through (v), (3)(i) and (ii), 
(4)(iii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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 (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)(iii) 
of this section.


Sec.  721.11226  2-Pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-
fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride 
(1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-
5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (PMN P-16-516; CAS 
No. 2173150-90-6) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iv), (3) through (6)(i) and (ii), (v) and 
(vi), (b) (concentration set at 0.1%), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For Sec.  721.63(a)(5), respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set 0.1%), (f), (g)(1)(i) and 
(ii), (iv), (vi), (vii) and (ix), (2)(i) through (v), (3)(i) and (ii), 
(4)(iii), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k). It is a significant new use to 
manufacture the substance beyond nine months.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (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 (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)(iii) 
of this section.


Sec.  721.11227  1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, 1,2,4-trinonyl ester (PMNs P-16-271 and P-
16-450, CAS No. 35415-27-1) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been incorporated into a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) through (3) and (6) (particulate), (b) (concentration set 
at 1.0%), and (c). When determining which persons are reasonable likely 
to be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(iv), (vi) and (ix), (2)(i) and (v), and (4)(i) through (iii) and (v). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (p) (1,750,000 kilograms). It is a 
significant new use to use the substance other than as a plasticizer in 
wire and cable insulation.
    (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 (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.


Sec.  721.11228  Aliphatic polyamines, polymers with bisphenol A and 
epichlorohydrin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic polyamines, polymers with bisphenol A and epichlorohydrin 
(PMN P-16-388) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3) and (6)(v) and (vi) (particulate), 
(b) (concentration set at 1.0%) and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace

[[Page 66607]]

policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) 
((mucous membrane irritation), (lung irritation), (eye irritation)), 
(2)(i) (use gloves and eye protection), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (o).
    (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 (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  721.11229  Epoxy-amine adduct, methanesulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as epoxy-
amine adduct, methanesulfonates (PMNs P-16-489, P-16-490, and P-16-491) 
are subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section. The requirements of 
this section do not apply to quantities of the substance after they 
have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(2)(ii), (3)(i) and (ii), and (5). Alternative hazard and warning 
statement that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to 
manufacture, process, or use the substances resulting in inhalation 
exposure to vapor, mist, or aerosols.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=208 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), (f) through (h), (i), and (k) 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


Sec.  721.11230  Modified ethylene-vinyl alcohol copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (2) The chemical substance identified generically as 
modified ethylene-vinyl alcohol copolymer (PMN P-16-509) is subject to 
reporting under this section for the significant new use described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance with 
particle size less than 50 microns.
    (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.


Sec.  721.11231  Cashew, nutshell liq., polymer with acid and 
halohydrin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cashew, 
nutshell liq., polymer with acid and halohydrin (PMN P-16-546) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iv), (3) through (6)(v) and (vi) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63 (a)(1) and (4) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor (APF) of at 
least 50, or an APF of 1000 where the PMN substance has a use involving 
an application method that generates vapor, mist or aerosol.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1) ((skin sensitization), (respiratory 
sensitization)), (2)(i) through (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (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 (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.


Sec.  721.11232  Pentaerythritol ester of mixed linear and branched 
carboxylic acids (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
pentaerythritol ester of mixed linear and branched carboxylic acids 
(PMN P-16-589) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3) and (6) (particulate), (b) (concentration set at 
1.0%), and (c). When determining which persons are reasonable likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g. enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible.

[[Page 66608]]

    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iv) 
through (vi) and (ix), (2)(i) through (v), (4) (minimize release to 
water), and (5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture or process this substance in any manner that results in 
inhalation exposure.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4) and (b)(4), where N=330 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 (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 significant new use rule.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  721.11233  Cashew nut shell liquid, branched polyester-polyether 
polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cashew 
nut shell liquid, branched polyester-polyether polyol (PMN P-17-116) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3) and (6) (particulate), (b) (concentration set 
at 0.1%) and (c). When determining which persons are reasonably likely 
to be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible.
    (ii) Hazard communication: Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1) 
(sensitization), (2)(i) and (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (p) (65,000 kg), and (y)(1). It is a 
significant new use to manufacture the PMN substance with greater than 
0.1% weight residual cashew nut oil.
    (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 (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.


Sec.  721.11234  Methylene diphenyl diisocyanate terminated 
polyurethane resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
methylene diphenyl diisocyanate terminated polyurethane resin (PMN P-
17-121) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5) and (6)(v) and 
(vi) (particulate), (b) (concentration set at 1.0%) and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For Sec.  721.63(a)(5), respirators must 
provide NIOSH assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i) and 
(ii) (asthma), (2)(i) through (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance for 
consumer use or for commercial uses that could introduce the substance 
into a consumer setting. It is a significant new use to manufacture the 
substance without conducting medical surveillance as specified in the 
Order. It is a significant new use to use the substance in a spray 
application that results in inhalation exposure to a vapor, dust, mist, 
spray, or aerosol.
    (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 (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.


Sec.  721.11235  2-Furancarboxylic acid, tetrahydro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-furancarboxylic 
acid, tetrahydro- (PMN P-17-328, CAS No. 16874-33-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5) and (6)(v) and 
(vi) (particulate), (b) (concentration set at 1.0%), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(vi) 
((severe eye irritation), (blood effects), (immunotoxicity)), (2)(i) 
through (iii) and (v) (eye protection), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f).
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 66609]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (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.


Sec.  721.11236  Heteromonocycle, homopolymer, alkyl substituted 
carbamate, alkyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
heteromonocycle, homopolymer, alkyl substituted carbamate, alkyl ester 
(PMN P-17-373, chemical A and P-13-373 chemical B) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of the TSCA Order do 
not apply to quantities of the substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3) through (5) and (6)(v) and (vi) 
(particulate), (b) (concentration set at 0.1%) and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(vii) and (ix) ((sensitization), (systemic effects)), (2)(i) through 
(iii) and (v), and (5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture the substances unless the number average molecular weight 
is greater than or equal to 1000 Daltons. It is a significant new use 
to use the substances other than as an ultraviolet curable coating 
resin.
    (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 (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.


Sec.  721.11237  Polysiloxanes, di alkyl, substituted alkyl group 
terminated, alkoxylated, reaction products with alkanoic acid, 
isocyanate substituted-alkyl carbomonocycle and polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polysiloxanes, di alkyl, substituted alkyl group terminated, 
alkoxylated, reaction products with alkanoic acid, isocyanate 
substituted-alkyl carbomonocycle and polyol (PMN P-17-374) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section. The requirements of the TSCA Order 
do not apply to quantities of the PMN substance after they have been 
completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3) through (5) and (6)(v) and (vi) 
(particulate), (b) (concentration set at 0.1%), and (c). When 
determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures.) shall be considered and implemented to 
prevent exposure, where feasible. For Sec.  721.63(a)(5), respirators 
must provide a NIOSH assigned protection factor of at least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(vii) and (ix) ((sensitization), (systemic effects)), (2)(i) through 
(iii) and (v), and (5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import 
the substance with more than 0.1% residual isocyanate. It is a 
significant new use to import the substance at a number average 
molecular weight less than 1000 Daltons. It is a significant new use to 
use the substance other than as an ultraviolet curable coating resin.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=110.
    (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 (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.


Sec.  721.11238  Substituted carbomonocycle, polymer with substituted 
heteromonocycle and substituted polyalkylene glycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with substituted heteromonocycle 
and substituted polyalkylene glycol (PMN P-18-17) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate), 
(b) (concentration set at 0.1%), and (c). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible. For Sec.  721.63(a)(5), respirators must provide a 
National Institute for Occupational Safety and Health assigned 
protection factor of at least 1000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i) 
through (vii) and (ix) (irritation to eyes, lungs, and mucus 
membranes), (2)(i) through (v) (avoid eye contact), and (5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized

[[Page 66610]]

System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), It is a significant new use to import 
the substance if the average molecular weight is less than or equal to 
1000 Daltons, more than 10% is less than 500 Daltons, or more than 25% 
is less than 1000 Daltons. It is a significant new use to use the 
substance other than for primer coating for corrosion protection.
    (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 (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.


Sec.  721.11239  Alkanedioic acid, polymers with alkanoic acid-
dipentaerythritol reaction products, substituted alkanedioc acid, 
substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl 
substituted carbomonocycle and alkyl substituted alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkanedioic acid, polymers with alkanoic acid-dipentaerythritol 
reaction products, substituted alkanedioc acid, substituted alkanoic 
acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and 
alkyl substituted alkanediol (PMN P-18-40) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate), 
and (c). When determining which persons are reasonably likely to be 
exposed as required for Sec.  721.63(a)(1) and (4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. For Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 1000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i), (vii) and (ix) ((irritation to 
eyes, lungs, and mucous membranes), (dermal sensitization), 
(respiratory sensitization)), (2)(i) through (v), and (5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import 
the substance if the number average molecular weight is less than or 
equal to 1000 Daltons or greater than 20% of the acid moiety. It is a 
significant new use to use the substance other than as a binder for 
ultraviolet curable coating resins.
    (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 (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.


Sec.  721.11240  Substituted carbomonocycle, polymer with 
diisocyanatoalkane, substituted alkylacrylate blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with diisocyanatoalkane, 
substituted alkylacrylate blocked (PMN P-18-46) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (6) (particulate), 
(b)(concentration set at 0.1%), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
1000).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 0.1%), (f), (g)(1)(i), 
(iv), (v), (vii) and (ix) ((irritation to eyes, lungs, and mucus 
membranes), (dermal and respiratory sensitization)), (2)(i) through (v) 
(avoid eye contact), and (5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import 
the substance if the average molecular weight is less than or equal to 
1,390 Daltons, more than 11% is less than 500 Daltons, or more than 30% 
is less than 1,000 Daltons. It is a significant new use to use the 
substance other than as an ultraviolet curable resin.
    (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 (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.


Sec.  721.11241  1,2-Ethanediol, 1,2-dibenzoate.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2-Ethanediol, 
1,2-dibenzoate (PMN P-18-47, CAS No. 94-49-5) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
entrained in a polymer matrix.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1) through (5) and (6)(v) and (vi) (particulate), (b) 
(concentration set at 1.0%), and (c). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1) 
and (4), engineering control measures (e.g., enclosure or confinement 
of the operation, general and local ventilation) or administrative 
control measures (e.g., workplace policies and procedures) shall be 
considered and implemented to prevent exposure, where feasible. For 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational

[[Page 66611]]

Safety and Health assigned protection factor of at least 25.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(iii), 
(iv), (vi), (viii) and (ix) (blood effects), (2)(i) and (ii), (iv) and 
(v), (3)(i) and (ii), and (5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a phlegmatizer (stabilizer for compounds 
susceptible to detonation) for peroxides for use with polyester and 
vinyl ester resins as well as with curable unsaturated polyester and 
methacrylic resins.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4), where N=10.
    (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 (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.


Sec.  721.11242  Alkenoic acid, reaction products with 
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with 
isocyanatoalkane and substituted alkanoic acid, substituted 
monoacrylate alkanoate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkenoic acid, reaction products with 
[oxybis(alkylene)]bis[(substituted alkyl)-alkanediol], polymers with 
isocyanatoalkane and substituted alkanoic acid, substituted 
monoacrylate alkanoate-blocked (PMN P-18-51) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii) and (iv), (3) through (5), and (6) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor of at least 
1000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i) and (ix) ((irritation to eyes, 
lungs, and mucous membranes), (dermal sensitization), (respiratory 
sensitization)), (2)(i) through (v) (avoid eye contact), and (5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a waterborne ultraviolet curable coating resin 
binder for inkjet, ink, or overprint varnish. It is a significant new 
use to import the substance with greater than 24% of the branched alkyl 
acid moiety content. It is a significant new use to import the 
substance with greater than 0.1% isocyanate content.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=660.
    (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 (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.


Sec.  721.11243  Aromatic dicarboxylic acid, compound with alkane 
diamines, polymer with alkane diamine and dicarboxylic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic dicarboxylic acid, compound with alkane diamines, polymer with 
alkane diamine and dicarboxylic acid (PMN P-18-71) 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. It is a 
significant new use to manufacture the substance with particle size 
less than 10 microns.
    (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 significant new use rule.


Sec.  721.11244  Aromatic dicarboxylic acid, compound with alkyl 
diamines, homopolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic dicarboxylic acid, compound with alkyl diamines, homopolymer 
(PMN P-18-79) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new use is:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance with particle size 
less than 10 microns.
    (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 significant new use rule.


Sec.  721.11245  Aspartic acid, tallow modified diester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aspartic acid, tallow modified diester (PMN P-18-82) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), and (3), (b) (concentration set at 
1.0%), and (c). When determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(1), engineering control 
measures (e.g., enclosure or confinement of the operation, general

[[Page 66612]]

and local ventilation) or administrative control measures (e.g., 
workplace policies and procedures) shall be considered and implemented 
to prevent exposure, where feasible.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), (ii) 
and (iv), (2)(i), (ii) and (v), (3)(i) and (ii), (4)(iii) (above 
concentration of 1 part per billion (ppb), and (5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g). It is a significant new use to 
manufacture, process, or use the substance that results in inhalation 
exposure. It is a significant new use to manufacture, process and use 
the substance other than as stated in the PMN.
    (iv) Disposal. Residuals must be recycled back into the process as 
stated in the PMN.
    (v) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), (c)(4), where N=1.
    (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 (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 paragraphs (a)(2)(iii) 
and (iv) of this section.


Sec.  721.11246  Substituted alkanediol, polymer with heteromonocycles, 
alkenoate, metal complexes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted alkanediol, polymer with heteromonocycles, alkenoate, metal 
complexes (PMN P-18-130) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i) and (iii), (3) through (5) and (6)(v) and (vi) 
(particulate), and (c). When determining which persons are reasonably 
likely to be exposed as required for Sec.  721.63(a)(1) and (4) 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. For Sec.  
721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health assigned protection factor (APF) of at 
least 50, or if spray applied an APF of 1000.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(i) ((sensitization), 
(mutagenicity)), (2)(i) through (v), and (5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as an adhesion promoter for industrial 
applications.
    (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 (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. 2019-26224 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P