Significant New Use Rules on Certain Chemical Substances (18-3), 1104-1119 [2019-26227]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Rules and Regulations]
[Pages 1104-1119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26227]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0650; FRL-10001-94]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (18-3)

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 certain chemical substances 
that are the subject of premanufacture notices (PMNs) and Orders issued 
by EPA under TSCA. This final rule requires 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 March 9, 2020. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
January 23, 2020.

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 February 10, 
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 https://www.regulations.gov or at the 
Office of Pollution Prevention and 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 
https://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical 
substances identified in Unit V. These SNURs require persons who intend 
to manufacture or process any of these chemical substances for an 
activity that

[[Page 1105]]

is designated as a significant new use to notify EPA at least 90 days 
before commencing that activity.
    In the Federal Register of November 15, 2018 (83 FR 57634) (FRL-
9985-22), EPA proposed SNURs for these chemical substances be added to 
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 SNUR. The record for these SNURs, 
established under docket ID number EPA-HQ-OPPT-2018-0650, includes 
information considered by the Agency in developing the proposed and 
final rules, public comments submitted for the proposed rule, and EPA's 
responses to public comments received.

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

    TSCA section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA 
to determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four 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), 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 on the proposed rule from four 
identifying entities. The Agency's responses are described in a 
separate Response to Public Comments document contained in the docket 
for this rule, EPA-HQ-OPPT-2018-0650. EPA is finalizing the SNURs as 
proposed in this rule.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements in 40 CFR part 721, subpart E, for the chemical substances 
identified in this unit. In Unit IV. of the proposed rule published on 
November 15, 2018 (83 FR 57634) (FRL-9985-22), 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 Order, or if a manufacturer 
or processor is considering submitting a SNUN for a significant new use 
designated by the SNUR.
     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 chemical substances are the subject of PMNs and Orders issued 
by EPA 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. 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 TSCA Orders, consistent with TSCA section 
5(f)(4).
    Where EPA determined that the PMN substance may present an 
unreasonable

[[Page 1106]]

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 Sec.  721.63 
respirator requirements may request to do so under Sec.  721.30. EPA 
expects that persons whose Sec.  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 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

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 41 of the 67 
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 November 15, 2018 (the date of public 
release of the proposed rule) 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 November 15, 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 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. Unit IV. 
of the proposed rule (83 FR 57634; November 15, 2018) 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

[[Page 1107]]

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 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 
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 section 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should 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 721.25. E-PMN software is available 
electronically at https://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-2018-0650.

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 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

[[Page 1108]]

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).

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 21, 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.  721.11194 through 721.11220 
in numerical order under the undesignated

[[Page 1109]]

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
------------------------------------------------------------------------
 
                                * * * * *
721.11194...............................................       2070-0012
721.11195...............................................       2070-0012
721.11196...............................................       2070-0012
721.11197...............................................       2070-0012
721.11198...............................................       2070-0012
721.11199...............................................       2070-0012
721.11200...............................................       2070-0012
721.11201...............................................       2070-0012
721.11202...............................................       2070-0012
721.11203...............................................       2070-0012
721.11204...............................................       2070-0012
721.11205...............................................       2070-0012
721.11206...............................................       2070-0012
721.11207...............................................       2070-0012
721.11208...............................................       2070-0012
721.11209...............................................       2070-0012
721.11210...............................................       2070-0012
721.11211...............................................       2070-0012
721.11212...............................................       2070-0012
721.11213...............................................       2070-0012
721.11214...............................................       2070-0012
721.11215...............................................       2070-0012
721.11216...............................................       2070-0012
721.11217...............................................       2070-0012
721.11218...............................................       2070-0012
721.11219...............................................       2070-0012
721.11220...............................................       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.  721.11194 through 721.11220 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
* * * * *
721.11194 Alkene reaction and distillation by-products and residues 
(generic).
721.11195 Oxirane, 2-methyl-, polymer with oxirane, monobutyl ether, 
monoether with propylene oxide-2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane polymer.
721.11196 Aliphatic acrylate (generic).
721.11197 Flue dust, glass-manufg. desulfurization. Definition: The 
dust produced from the flue gas exhaust cleaning of a glass 
manufacturing process using carbonate containing substances. It 
consists primarily of Na2S04, Na2CO3, and Na4(SO4)(CO3).
721.11198 Organo-titanate (generic).
721.11199 Dialkyl 7,10-dioxa, dithiahexadeca diene (generic).
721.11200 Haloalkyl substituted carbomonocycle (generic).
721.11201 Amine- and hydroxy-functional acrylic polymer, neutralized 
(generic).
721.11202 Amine- and hydroxy-functional acrylic polymer (generic).
721.11203 Hydroxy acrylic polymer, methanesulfonates (generic).
721.11204 Alkyl perfluorinated acryloyl ester (generic).
721.11205 Poly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-2-propen-1-
yl)-.omega.-hydroxy-.
721.11206 Alkylidene dicarbomonocycle, polymer with halo-substituted 
heteromonocycle and disubstituted alkyl carbomonocycle alkenedioate 
alkylalkenoate (generic).
721.11207 Aluminum boron cobalt lithium nickel oxide.
721.11208 Aluminum boron cobalt lithium magnesium nickel oxide.
721.11209 Heteropolycyclic-alkanol carbomonocycle-alkanesulfonate 
(generic).
721.11210 (Substituted-dialkyl(C=1~7)silyl)alkanenitrile (generic).
721.11211 Substituted heteromonocycle, polymer with diisocyanato 
alkane and alkanediol, substituted heteromonocycle homopolymer ester 
with substituted alkylacrylate; blocked (generic).
721.11212 Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, sodium salts.
721.11213 Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, potassium salts.
721.11214 2-Propenoic acid, 2-methyl-, 2-(2-butoxyethoxy)ethyl 
ester, polymer with 1,3-butadiene and 2-propenenitrile.
721.11215 Halogenated benzoic acid ethyl ester (generic).
721.11216 Halogenated benzoic acid (generic).
721.11217 Certain halogenated sodium benzoate salts.
721.11218 Benzoic acid, 2, 3, 6-trifluoro, sodium salt (1:1).
721.11219 Fatty acids, diesters with dihydroxyalkane, fatty acids, 
esters with dihydroxyalkane (generic) (P-18-3, chemical A and B).
721.11220 Substituted carbomonocycle, polymer with halo substituted 
heteromonocycle and polyoxyalkylene polymer with 
alkylenebis[isocyanatocarbomonocycle] bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed (generic).
* * * * *


Sec.  721.11194  Alkene reaction and distillation by-products and 
residues (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkene 
reaction and distillation by-products and residues (PMN P-15-106) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (4), and (5), (a)(6)(v) and 
(vi), (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) and (3), 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 purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10.
    (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 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)(i), 
(ii), and (ix), (g)(2)(i), (ii), (iv), and (v) (use respiratory 
protection or maintain workplace airborne concentrations at or below an 
8-hour time-weighted average of 2 mg/m\3\), (g)(3)(ii), (g)(4) (do not 
release to water at concentrations that exceed 1 ppb), and (g)(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(q).

[[Page 1110]]

    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (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.  721.11195  Oxirane, 2-methyl-, polymer with oxirane, monobutyl 
ether, monoether with propylene oxide-2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane polymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2-methyl-, 
polymer with oxirane, monobutyl ether, monoether with propylene oxide-
2-[[3-(triethoxysilyl)propoxy]methyl]oxirane polymer (PMN P-15-726, CAS 
No. 1644400-33-8) 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) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that generates a vapor, dust, 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 (c) and (f) 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.  721.11196  Aliphatic acrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic acrylate (PMN P-16-337) 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 Sec.  
721.63(a)(1), (a)(2)(i), (iii), and (iv), (a)(3), (4), and (5), 
(a)(6)(v) and (vi) (particulate), (b) (concentration set at 0.1%), and 
(c). When determining which persons are reasonable 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health with 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), (ii), 
(iv), (vii), and (ix), (g)(2)(i) through (v), (g)(3)(i) and (ii), 
(g)(4) (release restrictions apply), and (g)(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).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (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 (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.  721.11197  Flue dust, glass-manufg. desulfurization. Definition: 
The dust produced from the flue gas exhaust cleaning of a glass 
manufacturing process using carbonate containing substances. It 
consists primarily of Na2S04, Na2CO3, and Na4(SO4)(CO3).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as flue dust, glass-
manufg. desulfurization. Definition: The dust produced from the flue 
gas exhaust cleaning of a glass manufacturing process using carbonate 
containing substances. It consists primarily of Na2S04, Na2CO3, and 
Na4(SO4)(CO3) (PMN P-16-421, CAS No. 1916486-36-6) 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 incorporated into a glass product.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (4), and (5), (a)(6)(v) and (vi) (particulate), and 
(c). When determining which persons are reasonable 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 50 or when the PMN 
substance is in a mixture at a concentration below 1.0 percent by 
weight, an APF of 10.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(iii), (iv), (vi), and (ix) 
(cardiovascular effects), (a)(2)(i) through (v), and (a)(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(h). It is a significant new use to modify 
the processes or uses described in the premanufacture notice such that 
occupational exposure is increased. It is a significant new use to 
manufacture the substance with an elemental composition different from 
that described in the PMN.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 1111]]

apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (f) 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.  721.11198  Organo-titanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organo-
titanate (PMN P-16-600) 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) and (3), (a)(6) (particulate), (b) (concentration set at 
0.1%), 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 0.1%), (f), (g)(1)(vii), 
(g)(2)(i) and (v), (g)(3)(ii), (g)(4)(iii), and (g)(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 process 
or use the substance involving an application method that generates a 
vapor, mist, or aerosol.
    (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.  721.11199  Dialkyl 7,10-dioxa, dithiahexadeca diene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as dialkyl 
7,10-dioxa, dithiahexadeca diene (PMN P-17-7) 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), (a)(2)(i), (iii), and (iv), (a)(3), (a)(6)(v) and (vi) 
(particulate), (b)(concentration set at 0.1%), 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 0.1%), (f), (g)(1)(iv), 
(vi), (vii), and (ix) ((skin sensitization), (respiratory 
sensitization)), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), 
(g)(4)(i), and (g)(5). Alternative hazard 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 involving an application 
method that generates a vapor, mist, dust, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=67.
    (b) Specific requirements. The provision 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.  721.11200   Haloalkyl substituted carbomonocycle (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
haloalkyl substituted carbomonocycle (PMN P-17-49) 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 Sec.  
721.63(a)(1), (a)(2)(i) through (iv), (a)(3), (4), (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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health with assigned protection factor of at 
least 10.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(ix) ((irritation) (sensitization) 
(liver toxicity) (mutagenicity)), (g)(2)(i) through (v), (g)(4)(i) and 
(iii), and (g)(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), (k), and (t). It is a significant new 
use to use the substance without the confidential engineering controls 
specified in the TSCA section 5(e) Order.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) 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 (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.

[[Page 1112]]

Sec.  721.11201  Amine- and hydroxy-functional acrylic polymer, 
neutralized (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine- 
and hydroxy-functional acrylic polymer, neutralized (PMN P-17-249) 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 dried coating.
    (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), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used. For purposes 
of Sec.  721.63(g)(4)(i), do not release to water without pre-treatment 
of water releases at an onsite waste water treatment plant with at 
least 96% efficiency.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the TSCA section 5(e) Order. It is a significant new use to manufacture 
or use the substance with methods that generate a dust, spray, mist, or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (iv) Release to water. It is a significant new use to release to 
water without pretreatment at an on-site wastewater treatment plant 
with at least 96% efficiency.
    (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 (f) 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 paragraph (a)(2)(ii) of 
this section.


Sec.  721.11202  Amine- and hydroxy-functional acrylic polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine- 
and hydroxy-functional acrylic polymer (PMN P-17-380) 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 dried coating.
    (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), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used. For purposes 
of Sec.  721.63(g)(4)(i), do not release to water without pre-treatment 
of water releases at an onsite waste water treatment plant with at 
least 96% efficiency.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the TSCA section 5(e) Order. It is a significant new use to manufacture 
or use the substance with methods that generate a dust, spray, mist, or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (iv) Release to water. It is a significant new use to release to 
water without pretreatment at an on-site wastewater treatment plant 
with at least 96% efficiency.
    (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 (f) 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 paragraph (a)(2)(ii) of 
this section.


Sec.  721.11203  Hydroxy acrylic polymer, methanesulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
acrylic polymer, methanesulfonates (PMN P-17-381) 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 dried coating.
    (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), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used. For purposes 
of Sec.  721.63(g)(4)(i), do not release to water without pre-treatment 
of water releases at an onsite waste water treatment plant with at 
least 96% efficiency.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the TSCA section 5(e) Order. It is a significant new use to manufacture 
or use the substance with methods that generate a dust, spray, mist, or 
aerosol.
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (iv) Release to water. It is a significant new use to release to 
water without pretreatment at an on-site wastewater treatment plant 
with at least 96% efficiency.
    (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 (f) 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 paragraph (a)(2)(ii) of 
this section.


Sec.  721.11204  Alkyl perfluorinated acryloyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
perfluorinated acryloyl ester (PMN P-17-270) 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

[[Page 1113]]

they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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.  721.11205  Poly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-2-propen-
1-yl)-.omega.-hydroxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-(2-methyl-2-propen-1-yl)-.omega.-hydroxy- (PMN P-
17-271, CAS No. 31497-33-3) 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 substances after they have been 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), 
(g)(2)(ii) and (iii), and (g)(5). Alternative hazard and warning 
statements 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(f). It is a significant new use to use the 
substance other than as a polymer intermediate. It is a significant new 
use to manufacture, process or use the substance in a manner that 
generates a vapor, mist, or aerosol, or that results in inhalation 
exposure.
    (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 (f) 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.  721.11206  Alkylidene dicarbomonocycle, polymer with halo-
substituted heteromonocycle and disubstituted alkyl carbomonocycle 
alkenedioate alkylalkenoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylidene dicarbomonocycle, polymer with halo-substituted 
heteromonocycle and disubstituted alkyl carbomonocycle alkenedioate 
alkylalkenoate (PMN P-17-304) 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 it has been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (a)(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 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)(ii) 
(skin sensitization), (g)(2)(i), (ii), and (v), and (g)(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 intermediate for thermoset plastic material. 
It is a significant new use to manufacture (includes importing) the 
substance to contain more than 0.1% residual isocyanate by weight.
    (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.  721.11207  Aluminum boron cobalt lithium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum boron 
cobalt lithium nickel oxide (PMN P-17-337, CAS No. 207803-51-8) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (ii), (a)(3)(i) and (ii), (a)(4) and (5), 
(b) (concentration set at 0.1%), 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. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 1,000.
    (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 0.000092 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 0.1%), (f), (g)(1)(i) and 
(vii) (damage to the lung, kidney, and spleen), (g)(2)(i), (iii), and 
(iv), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used. For purposes of Sec.  721.63(g), 
use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\, and avoid breathing substance in the dust form.

[[Page 1114]]

    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance beyond two years. It 
is a significant new use to manufacture or process the substance at any 
facility unless all process air streams containing the substances pass 
through control technology such as a high-efficiency particulate air 
filter with a rated removal efficiency of at least 99.99%.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to dispose of the 
substance by metal reclamation unless the person reclaiming metal 
containing the substance complies with this section. It is a 
significant new use to release the substance to air unless the chemical 
transfer and air ventilation processes specified in the TSCA section 
5(e) Order are followed.
    (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 (j) 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)(iv) of 
this section.


Sec.  721.11208  Aluminum boron cobalt lithium magnesium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum boron 
cobalt lithium magnesium nickel oxide (PMN P-17-338, CAS No. 2087499-
33-8) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (ii), (a)(3)(i) and (ii), (a)(4) and (5), 
(b) (concentration set at 0.1%), 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. For purposes of Sec.  721.63(a)(5), respirators must 
provide a National Institute for Occupational Safety and Health 
assigned protection factor of at least 1,000.
    (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 0.000092 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 0.1%), (f), (g)(1)(i) and 
(vii) (damage to the lung, kidney, and spleen), (g)(2)(i), (iii), and 
(iv), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used. For purposes of Sec.  721.63(g), 
use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\, and avoid breathing substance in the dust form.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance beyond two years. It 
is a significant new use to manufacture or process the substance at any 
facility unless all process air streams containing the substances pass 
through control technology such as a high-efficiency particulate air 
filter with a rated removal efficiency of at least 99.99%.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to dispose of the 
substance by metal reclamation unless the person reclaiming metal 
containing the substance complies with this section. It is a 
significant new use to release the substance to air unless the chemical 
transfer and air ventilation processes specified in the TSCA section 
5(e) Order are followed.
    (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 (j) 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)(iv) of 
this section.


Sec.  721.11209  Heteropolycyclic-alkanol carbomonocycle-
alkanesulfonate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycyclic-alkanol carbomonocycle-alkanesulfonate (PMN P-17-343) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (a)(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), 
(vi), and (ix) ((eye irritation), (systemic effects)), (g)(2)(i) 
through (iii) and (v), (g)(3)(i) and (ii), and (g)(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 the substance in a manner that results in 
inhalation exposure to a vapor, mist, dust 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

[[Page 1115]]

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.  721.11210  (Substituted-dialkyl(C=1~7)silyl)alkanenitrile 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
(substituted-dialkyl(C=1~7)silyl)alkanenitrile (PMN P-17-354) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (4), and (5), (a)(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) 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health with 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)(ii), 
(iv), (vi), and (ix) ((skin and eye irritation), (sensitization), 
(mutagenicity)), (g)(2)(i) through (v) (use eye protection), (g)(3)(i) 
and (ii), (g)(4)(i) and (iii), and (g)(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).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1) (waste streams from use must be disposed of only by 
incineration with no less than 99.9% efficiency).
    (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 (j) 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.  721.11211  Substituted heteromonocycle, polymer with diisocyanato 
alkane and alkanediol, substituted heteromonocycle homopolymer ester 
with substituted alkylacrylate; blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heteromonocycle, polymer with diisocyanato alkane and 
alkanediol, substituted heteromonocycle homopolymer ester with 
substituted alkylacrylate- blocked (PMN P-17-361) 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), (a)(2)(i), (a)(3), (4), and (5), (a)(6)(v) and (vi) 
(particulate), (b) (concentration set at 0.1%), and (c). When 
determining which persons are reasonable 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health with assigned protection factor (APF) of at least 50 or an 
APF of at least 1,000 if spray applied.
    (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)), (g)(2)(i) 
through (v), and (g)(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 substance containing greater than 0.25% residual 
isocyanate or an average molecular weight less than 2,280 daltons. It 
is a significant new use to use the substance other than as a dual-cure 
adhesion coating or barrier.
    (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.  721.11212  Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, sodium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycolipids, 
sophorose-contg., candida bombicola-fermented, from C16-18 and C18-
unsatd. glycerides and D-glucose, hydrolyzed, sodium salts (PMN P-17-
401, CAS No. 2102535-74-8) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3) and (a)(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) and 
(ii) (eye irritation), (g)(2)(i) through (iii) and (v), and (g)(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, 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, process, or use 
the substance in any manner that results in generation of a vapor, 
dust, mist or aerosol.
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 1116]]

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.  721.11213  Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, potassium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycolipids, 
sophorose-contg., Candida bombicola-fermented, from C16-18 and C18-
unsatd. glycerides and D-glucose, hydrolyzed, sodium salts (PMN P-17-
402, CAS No. 2102536-64-9) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iii), (a)(3), (a)(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) and 
(ii) (eye irritation), (g)(2)(i) through (iii) and (v), and (g)(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, 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, process, or use 
the substance in any manner that results in generation of a vapor, 
dust, 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 section.


Sec.  721.11214  2-Propenoic acid, 2-methyl-, 2-(2-butoxyethoxy)ethyl 
ester, polymer with 1,3-butadiene and 2-propenenitrile.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
2-methyl-, 2-(2-butoxyethoxy)ethyl ester, polymer with 1,3-butadiene 
and 2-propenenitrile (PMN P-17-404, CAS No. 2058302-39-7) 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) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in the generation of spray, mist, aerosol, or 
respirable particles.
    (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.  721.11215  Halogenated benzoic acid ethyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically in table 
1 of this section are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.

   Table 1 of Sec.   721.11215--Halogenated Benzoic Acid Ethyl Esters
------------------------------------------------------------------------
              PMN No.                     Chemical name  (generic)
------------------------------------------------------------------------
P-17-405..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-406..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-407..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-408..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-409..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-410..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-411..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-412..........................  Halogenated benzoic acid ethyl
                                     ester.
P-17-423..........................  Halogenated benzoic acid ethyl
                                     ester.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (a)(4) and (a)(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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
use the substances other than for oil and gas well performance. It is a 
significant new use to manufacture or process the substances without 
the engineering controls specified in the TSCA section 5(e) Order. It 
is a significant new use to exceed the kilograms per day limit 
specified in the TSCA section 5(e) Order of the substances handled at 
processing and use sites.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=8.
    (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 these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.


Sec.  721.11216  Halogenated benzoic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically in the 
table 1 of this section are subject to reporting under this section for 
the significant new uses

[[Page 1117]]

described in paragraph (a)(2) of this section.

         Table 1 of Sec.   721.11216--Halogenated benzoic acids
------------------------------------------------------------------------
              PMN No.                     Chemical name  (generic)
------------------------------------------------------------------------
P-17-414..........................  Halogenated benzoic acid.
P-17-415..........................  Halogenated benzoic acid.
P-17-416..........................  Halogenated benzoic acid.
P-17-417..........................  Halogenated benzoic acid.
P-17-418..........................  Halogenated benzoic acid.
P-17-420..........................  Halogenated benzoic acid.
P-17-421..........................  Halogenated benzoic acid.
P-17-422..........................  Halogenated benzoic acid.
P-17-441..........................  Halogenated sodium benzoate.
P-17-442..........................  Halogenated sodium benzoate.
P-17-444..........................  Halogenated sodium benzoate.
P-17-445..........................  Halogenated sodium benzoate.
P-17-446..........................  Halogenated sodium benzoate.
P-17-447..........................  Halogenated sodium benzoate.
P-17-448..........................  Halogenated sodium benzoate.
P-17-449..........................  Halogenated sodium benzoate.
P-17-450..........................  Halogenated benzoic acid.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3), (4), and (5), (a)(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) 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 purposes of Sec.  721.63(a)(5), 
respirators must provide a National Institute for Occupational Safety 
and Health with assigned protection factor of at least 50, and 
respirators are only required for P-17-414 to P-17-418, P-17-420 to P-
17-422, and P-17-450.
    (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 the substances. The NCEL is 0.0184 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)(i) 
through (iv), (vi), and (ix), (g)(2)(i) through (iii), (v), and (iv), 
(g)(3)(i) and (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used. For purposes of Sec.  
721.63(g)(2), use respiratory protection or maintain workplace airborne 
concentration at or below an 8-hour time-weighted average of 0.0184 mg/
m\3\, and the statement is only required for P-17-414 to P-17-418, P-
17-420 to P-17-422, and P-17-450.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
use the substances other than for monitoring well performance. It is a 
significant new use to manufacture or process the substances without 
the engineering controls specified in the TSCA section 5(e) Order. It 
is a significant new use to exceed the kilograms per day limit 
specified in the TSCA section 5(e) Order of the substances handled at 
processing and use sites. It is a significant new use to use P-17-441 
to 442 and P-17-444 to P-17-449 other than in a liquid formulation.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=460.
    (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 these substances.
    (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.  721.11217  Certain halogenated sodium benzoate salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances listed in table 1 of this 
section are subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.

     Table 1 of Sec.   721.11217--Halogenated Sodium Benzoate Salts
------------------------------------------------------------------------
             PMN No.                   CAS No.          Chemical name
------------------------------------------------------------------------
P-17-424........................       1708942-16-8  Benzoic acid, 2-
                                                      chloro-3-methyl-,
                                                      sodium salt (1:1).
P-17-425........................       1708942-17-9  Benzoic acid, 3-
                                                      chloro-2-methyl-,
                                                      sodium salt (1:1).
P-17-426........................       1708942-15-7  Benzoic acid, 3-
                                                      chloro-4-methyl-,
                                                      sodium salt (1:1).
P-17-427........................        118537-88-5  Benzoic acid, 2-
                                                      chloro-5-methyl-,
                                                      sodium salt (1:1).
P-17-428........................        203261-42-1  Benzoic acid, 4-
                                                      chloro-2-methyl-,
                                                      sodium salt (1:1).
P-17-429........................       1708942-24-8  Benzoic acid, 3-
                                                      fluoro-2-methyl-,
                                                      sodium salt (1:1).
P-17-430........................       1805805-74-6  Benzoic acid, 3-
                                                      fluoro-4-methyl-,
                                                      sodium salt (1:1).
P-17-431........................       1708942-23-7  Benzoic acid, 4-
                                                      fluoro-2-methyl-,
                                                      sodium salt (1:1).
P-17-432........................       1708942-19-1  Benzoic acid, 2-
                                                      fluoro-4-methyl-,
                                                      sodium salt (1:1).
P-17-433........................       1708942-18-0  Benzoic acid, 2-
                                                      fluoro-3-methyl-,
                                                      sodium salt (1:1).
P-17-435........................       1701446-41-4  Benzoic acid, 2-
                                                      fluoro-3-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).
P-17-436........................       1708942-20-4  Benzoic acid, 2-
                                                      fluoro-4-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).
P-17-437........................       1708942-21-5  Benzoic acid, 2-
                                                      fluoro-6-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).

[[Page 1118]]

 
P-17-438........................       1535169-59-5  Benzoic acid, 3-
                                                      fluoro-5-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).
P-17-439........................       1701446-39-0  Benzoic acid, 4-
                                                      fluoro-3-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).
P-17-440........................       1708942-22-6  Benzoic acid, 4-
                                                      fluoro-2-
                                                      (trifluoromethyl)-
                                                      , sodium salt
                                                      (1:1).
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3) and (a)(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), 
(iii), (iv), (vi), and (ix), (g)(2)(i) through (iii) and (v), (g)(3)(i) 
and (ii), and (g)(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 handle 
at a processing or use site more than 50 kilograms per day per site in 
aggregate of the PMN substances for solid formulations that generate a 
dust. It is a significant new use to use the substances other than as 
tracers in aqueous solution, in solid blends with polymers, or in a 
solid proppant bead forms to measure flow in deep oil-bearing or gas-
bearing strata.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=300.
    (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 these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11218  Benzoic acid, 2, 3, 6-trifluoro, sodium salt (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzoic acid, 2, 3, 
6-trifluoro, sodium salt (1:1) (PMNs P-17-434 and P-17-443, CAS No. 
1803845-07-9) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i) and (iv), (a)(3) and (a)(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), 
(iii), (iv), (vi), and (ix), (g)(2)(i) through (iii) and (v), and 
(g)(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(q). It is a significant new use to 
manufacture the substance other than in a liquid formulation and 
without the confidential engineering controls specified in the TSCA 
section 5(e) Order for P-17-443. It is a significant new use new use to 
use the substance other than as a tracer in aqueous solution, a solid 
blend with polymer, or a solid proppant bead form to measure flow in 
deep oil-bearing or gas-bearing strata or for the confidential use 
specified in the Order for P-17-443.
    (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.  721.11219  Fatty acids, diesters with dihydroxyalkane, fatty 
acids, esters with dihydroxyalkane (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acids, diesters with dihydroxyalkane, fatty acids, esters with 
dihydroxyalkane (PMN P-18-3, chemical A and P-18-3, 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 this 
section do not apply to quantities of the substances 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), (a)(2)(i), (iii), and (iv), (a)(3) and (a)(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) (skin 
and eye irritation and sensitization), (g)(2)(i) through (iii), and 
(v), and (g)(5). Alternative hazard and warning statements that meet 
the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (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 (h) 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.

[[Page 1119]]

Sec.  721.11220  Substituted carbomonocycle, polymer with halo 
substituted heteromonocycle and polyoxyalkylene polymer with 
alkylenebis[isocyanatocarbomonocycle] bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with halo substituted 
heteromonocycle and polyoxyalkylene polymer with 
alkylenebis[isocyanatocarbomonocycle] bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed (PMN P-18-22) 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), (a)(2)(i), (iii), and (iv), (a)(3), (4), (5), and (6) 
(particulate), and (c). When determining which persons are reasonable 
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 purposes of 
Sec.  721.63(a)(5), respirators must provide a National Institute for 
Occupational Safety and Health with assigned protection factor of at 
least 50.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(ii) (irritation to skin, eyes, 
lungs, and mucous membranes), (g)(2)(i) through (v) (avoid eye 
contact), and (g)(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 primer coating used for corrosion protection. 
It is a significant new use to import the substance with an average 
molecular weight greater less than 1026 daltons, and with low weight 
fractions greater than 15.3% less than 500 daltons and 25% less than 
1000 daltons.
    (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. 2019-26227 Filed 1-8-20; 8:45 am]
BILLING CODE 6560-50-P