[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:
[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, 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