Document ID: EPA-HQ-OPPT-2020-0302-0021
Agency: epa
Document Type: Rule
Title: Modification of Significant New Uses of Certain Chemical Substances (20-2.M)
Posted Date: 2021-06-07T04:00Z

[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Rules and Regulations]
[Pages 30210-30215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11768]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2020-0302; FRL-10022-76]
RIN 2070-AB27

Modification of Significant New Uses of Certain Chemical 
Substances (20-2.M)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is amending significant new use rules (SNURs) issued under 
the Toxic Substances Control Act (TSCA) for certain chemical substances 
identified herein, which were the subject of premanufacture notices 
(PMNs) and significant new use notices (SNUNs). This action would amend 
the SNURs to allow certain new uses reported in the SNUNs without 
additional notification requirements and modify the significant new use 
notification requirements based on the actions and determinations for 
the SNUN submissions. EPA is issuing these amendments based on review 
of new and existing data for the chemical substances.

DATES: This rule is effective on August 6, 2021. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
June 21, 2021.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: William Wysong, New Chemicals 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 564-4163; email address: 
wysong.william@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

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, which 
would include the SNUR requirements. Chemical importers are subject to 
the TSCA section 13 (15 U.S.C. 2612) import provisions. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B. In addition, pursuant to 40 CFR 721.20, any persons who export or 
intend to export a chemical substance that is the subject of this rule 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

B. 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 docket identification (ID) number EPA-HQ-OPPT-2020-0302, 
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.
    Due to the public health emergency, the EPA Docket Center (EPA/DC) 
and Reading Room is closed to visitors with limited exceptions. The 
staff continues to provide remote customer service via email, phone, 
and webform. For the latest status information on EPA/DC services and 
docket access, visit https://www.epa.gov/dockets.

II. Background

A. What action is the Agency taking?

    EPA is issuing amendments to the SNURs for certain chemical 
substances in 40 CFR part 721 subpart E.
    Previously, in the Federal Register of November 18, 2020 (85 FR 
73439) (FRL-10013-54), EPA proposed amendments to the SNURs for these 
chemical substances and established the record for these SNUR 
amendments in the docket under docket ID number EPA-HQ-OPPT-2020-0302. 
That docket includes information considered by the Agency in developing 
the proposed and final rules, including public comments.

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

    TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule (i.e., a SNUR) after 
considering all relevant factors, including those listed in TSCA 
section 5(a)(2). EPA may also amend a SNUR promulgated under TSCA 
section 5(a)(2). Procedures and criteria for modifying or revoking SNUR 
requirements appear at 40 CFR 721.185. 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 SNUN to EPA at least 90 days 
before they manufacture, import, or process the chemical substance for 
that use. Persons who must report are described in 40 CFR 721.5.

C. Do the SNUR general provisions apply?

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the final rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the rule to uses occurring before the effective date 
of the final rule. Provisions relating to user fees appear at 40 CFR 
part 700. According to 40 CFR 721.1(c), persons subject to these SNURs 
must comply with the same notice requirements and EPA regulatory 
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In 
particular, these requirements include the information submission 
requirements of TSCA 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 significant new use is not likely to present 
an unreasonable risk of injury or take such

[[Page 30211]]

regulatory action as is associated with an alternative determination 
before the manufacture or processing for the significant new use can 
commence. If EPA determines that the significant new use is not likely 
to present an unreasonable risk, EPA is required under TSCA section 
5(g) to make public, and submit for publication in the Federal 
Register, a statement of EPA's findings.

III. Significant New Use Determination

A. Determination Factors

    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 whether and how to modify the significant new uses 
for the chemical substances that are the subject of these SNURs, EPA 
considered relevant information about the toxicity of the chemical 
substance, likely human exposures and environmental releases associated 
with possible uses, and the four TSCA section 5(a)(2) factors listed in 
this unit.

B. Procedures for Significant New Uses Claimed as Confidential Business 
Information (CBI)

    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) and has referenced it to apply to other SNURs.
    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 production volume limit is not 
exceeded by the amount 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.

IV. Public Comments

    EPA received three public comments in response to the proposed 
SNURs. None of the comments pertained to the proposed SNURs or the 
basis for these SNURs. As a result, EPA is finalizing the rules as 
proposed and is not responding to the comments.

V. Rationale of the Final Rule

    These amendments are based on EPA's determination under 40 CFR 
721.85(a)(3) that significant new use notices for some of the 
activities designated as significant new uses of the relevant chemical 
substances were submitted to EPA and after reviewing the notices, EPA 
concluded that there is no need to require additional notice from 
persons who propose to engage in identical or similar activities. In 
those instances where EPA expanded the scope of the significant new 
use, the Agency identified concerns, as discussed in Unit IV. of the 
proposed rule, associated with certain potential new uses. In addition 
to considering the factors discussed in Unit IV. of the proposed rule, 
EPA determined that those uses could result in changes in the type or 
form of exposure to the chemical substance, increased exposures to the 
chemical substance, and/or changes in the reasonably anticipated manner 
and methods of manufacturing, processing, distribution in commerce, and 
disposal of the chemical substance.

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

    To establish a significant new use, EPA must determine that the use 
is not ongoing. EPA solicited comments on the proposed rule, providing 
an opportunity for members of the public to indicate whether any of the 
uses which are not significant new uses under the current rules, but 
which would be regulated as ``significant new uses'' if the proposed 
rule is finalized, are ongoing. EPA received no comments that these 
uses were ongoing. Therefore, EPA concludes that the uses are not 
ongoing.
    EPA designated November 18, 2020 (the date of publication 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 the cutoff date, that person will have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, that person would 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.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 generally does not require 
development of any particular new information (e.g., generating test 
data) before submission of a SNUN. There is an exception: If a person 
is required to submit information for a chemical substance pursuant to 
a rule, order or consent agreement under TSCA section 4, then TSCA 
section 5(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

[[Page 30212]]

information known to or reasonably ascertainable by them (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. of the proposed rule 
lists potentially useful information for all SNURs addressed in this 
final rule. Descriptions are provided for informational purposes. The 
information identified in Unit IV. of the proposed rule will be 
potentially useful to EPA's evaluation of a chemical substance in the 
event that someone submits a SNUN for a significant new use pursuant to 
the SNURs addressed in this final rule. Companies who are considering 
submitting a SNUN are encouraged, but are not required, to develop the 
potentially useful information on the substance.
    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 dialogue with Agency representatives to help determine how 
best the submitter can meet both the data needs and the objective of 
TSCA section 4(h). For more information on alternative test methods and 
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
    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 sections 5(e) or 5(f). EPA recommends that 
potential SNUN submitters contact EPA early enough so that they will be 
able to conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances; and

VIII. 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 under 40 CFR part 720, 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 721.25 and 720.40. E-PMN software is 
available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket for this rulemaking.

X. 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 modifies SNURs for several new chemical substances that 
were the subject of PMNs and SNUNs. 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 PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection activities associated with these SNURs 
have already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0012 (EPA ICR No. 574). This action does not impose any 
burden requiring additional OMB approval. If an entity were to submit a 
SNUN to the Agency, the annual burden is estimated to average between 
30 and 170 hours per response. This burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    The listing of the OMB control numbers of the collection 
instruments and their subsequent codification in the table in 40 CFR 
9.1 satisfies the display requirements of the PRA and OMB's 
implementing regulations at 5 CFR part 1320. Since this ICR was 
previously subject to public notice and comment prior to OMB approval, 
and given the technical nature of the table in 40 CFR part 9, 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 in 40 CFR 9.1 without further notice 
and comment.

C. Regulatory Flexibility Act (RFA)

    Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., I hereby 
certify that promulgation of this SNUR would 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. 
Although some small entities may decide to pursue a significant new use 
in the future, EPA cannot presently determine how many, if any, there 
may be. However, 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, 12 in FY2016, 13 in FY2017, and 11 in FY2018. 
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

[[Page 30213]]

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 federalism implications because it is not 
expected to 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 
Tribe Governments

    This action will not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes, 
significantly or uniquely affect the communities of Indian Tribal 
governments, and does not 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)

    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).

K. Congressional Review Act (CRA)

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

List of Subjects in 40 CFR Part 721

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

    Dated: May 25, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.

    Therefore, for the reasons stated in the preamble, 40 CFR chapter I 
is amended as follows:

PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

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

0
2. Amend Sec.  721.983 by revising paragraphs (a)(1) and (a)(2)(ii) to 
read as follows:

Sec.  721.983  Sulfonyl azide intermediate (generic).

    (a) * * * (1) The chemical substance identified generically as 
sulfonyl azide intermediate (PMN P-99-1202 and SNUN S-15-6) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) * * *
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to import, 
process, or use this chemical substance as a powder unless less than 1% 
of particles by weight are less than 200 microns.
* * * * *

0
3. Amend Sec.  721.9675 by revising paragraphs (a)(1), (a)(2)(i), 
(a)(2)(ii) and (b)(1) to read as follows:

Sec.  721.9675  Titanate [Ti6O13 (2-)], dipotassium.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as titanate [Ti6O13 
(2-)], dipotassium (PMN P-90-226; SNUNs P-96-1408, S-08-6, S-09-4, S-
13-49, S-16-5, and S-17-6; CAS No. 12056-51-8) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) * * *
    (i) Protection in the workplace. For manufacturing, processing, and 
use of SN-17-6: Requirements as specified in Sec.  721.63(a)(4), (5), 
(6), and (c). When determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63(a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure, where feasible. 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 10. For purposes of 
Sec.  721.63(a)(6), the airborne form(s) of the substance include 
particulate (including solid or liquid droplets).
    (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) consent order for this substance. The NCEL is 0.8 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) consent order.
    (B) [Reserved]

[[Page 30214]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f) and (l). In addition, a significant new 
use of the substance is importation of the chemical substance if:
    (A) Manufactured by other than the method described in 
premanufacture notice P-90-226 and significant new use notices P-96-
1408, S-08-6, S-09-4, S-13-49, S-16-5, and S-17-6.
    (B) Manufactured producing respirable, acicular fibers with an 
average aspect ratio of greater than 5. The average aspect ratio is 
defined as the ratio of average length to average diameter. For 
manufacture of S-17-6: Manufacture with a particle size distribution 
containing greater than 30% of particles less than 10 microns.
    (b) * * *
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (d) and (i) are applicable to manufacturers and 
processors of this substance.
* * * * *

0
4. Amend Sec.  721.10288 by revising paragraphs (a)(1) and (a)(2)(i) to 
read as follows:

Sec.  721.10288  Cyclohexane, oxidized, by-products from, distn. 
residues.

    (a) * * * (1) The chemical substance identified as cyclohexane, 
oxidized, by-products from, distn. residues (PMN P-11-316; CAS No. 
1014979-92-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) * * *
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=470.
* * * * *

0
5. Amend Sec.  721.10432 by:
0
a. Revising paragraphs (a)(1), (a)(2)(i) and (a)(2)(ii);
0
b. Adding paragraphs (a)(2)(iii) and (iv); and
0
c. Revising paragraph (b)(1).
    The revisions and additions read as follows:

Sec.  721.10432  1,2,4,5,7,8-Hexoxonane, 3,6,9-triethyl-3,6,9-
trimethyl-.

    (a) * * * (1) The chemical substance identified as 1,2,4,5,7,8-
hexoxonane, 3,6,9-triethyl-3,6,9-trimethyl- (PMN P-98-1028 and SNUNs S-
14-9, S-17-12, and S-17-15; CAS No. 24748-23-0) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5), (a)(6)(v), (b), 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 assigned protection factor of at least 50. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1) through (3), (g)(4)(i), and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 1.0%. For 
purposes of Sec.  721.72(g)(1), the required human health hazard 
statements include: Internal organ effects; reproductive effects; 
allergic skin reaction. For purposes of Sec.  721.72(g)(2), the 
required human health precautionary statements include: Use skin 
protection; where engineering controls are not determined to be 
adequate, use respiratory protection. For purposes of Sec.  
721.72(g)(3), the required environmental hazard statements include: 
This substance may cause long lasting harmful effects to aquatic life. 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial commercial, and consumer activities. It is a 
significant new use to process or use the substance with an application 
method that generates a mist, vapor, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=56.
    (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.
* * * * *

0
6. Amend Sec.  721.10907 by revising paragraphs (a)(1) and (a)(2)(i) to 
read as follows:

Sec.  721.10907  Polyfluorohydrocarbon (generic).

    (a) * * * (1) The chemical substance identified generically as 
polyfluorohydrocarbon (PMN P-15-326 and SNUN S-17-11) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) * * *
    (i) Industrial commercial, and consumer activities. Requirements as 
specified in Sec.  721.80(o). It is a significant new use to use the 
substance other than for the confidential uses described in PMN P-15-
326 and SNUN S-17-11.
* * * * *

0
7. Amend Sec.  721.10922 by:
0
a. Revising paragraphs (a)(1), (a)(2)(i) and (a)(2)(ii);
0
b. Adding paragraphs (a)(2)(iii) and (iv);
0
c. Revising paragraph (b)(1); and
0
d. Removing paragraph (b)(3).
    The revisions and additions read as follows:

Sec.  721.10922  1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-
tris(alkyl) derivs. (generic).

    (a) * * * (1) The chemical substance identified generically as 
1,2,4,5,7,8-hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(alkyl) derivs. 
(PMN P-15-607 and SNUN S-17-13) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) * * *
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3) through (5), (a)(6)(v), (b), 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 assigned protection factor of at least 50. For purposes of 
Sec.  721.63(b), the concentration is set at 1.0%.
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (f), (g)(1) through (3), (g)(4)(i), and (g)(5). For 
purposes of Sec.  721.72(e), the concentration is set at 1.0%. For 
purposes of Sec.  721.72(g)(1), the required human health hazard 
statements include: Internal organ effects; reproductive effects; 
allergic skin reaction. For purposes of Sec.  721.72(g)(2), the 
required human health precautionary statements include: Use skin 
protection; where engineering controls are not determined to be 
adequate, use respiratory protection. For purposes of Sec.  
721.72(g)(3), the required environmental hazard statements include: 
This substance may cause long lasting harmful effects to aquatic life. 
Alternative hazard and warning statements that meet the criteria of the

[[Page 30215]]

Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial commercial, and consumer activities. It is a 
significant new use to process or use the substance with an application 
method that generates a mist, vapor, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4) and (c)(4), where N=56.
    (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.
* * * * *
[FR Doc. 2021-11768 Filed 6-4-21; 8:45 am]
BILLING CODE 6560-50-P