[Federal Register Volume 85, Number 208 (Tuesday, October 27, 2020)]
[Rules and Regulations]
[Pages 67996-68001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21464]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0614; FRL-10013-53]
RIN 2070-AB27
Modification of Significant New Uses of Certain Chemical
Substances (20-1.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, which were the subject of premanufacture notices (PMNs) and
significant new use notices (SNUNs). As a result of EPA's review of
SNUNs for these chemical substances and based on new and existing data,
EPA is finalizing amendments to these SNURs. Specifically, this action
amends the identified 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.
DATES: This rule is effective on December 28, 2020. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
November 10, 2020.
FOR FURTHER INFORMATION CONTACT:
For technical information contact: William Wysong, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-4163; 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
[[Page 67997]]
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
provisions 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, which would include 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 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and
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 docket identification (ID) number EPA-HQ-OPPT-2019-0263,
is available at http://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.
Due to the public health concerns related to COVID-19, 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. A SNUR for a chemical
substance designates certain activities as a significant new use.
Persons who intend to manufacture or process the chemical substance for
the significant new use must notify EPA at least 90 days before
commencing that activity. The required notification (i.e., a SNUN)
initiates EPA's evaluation of the intended use within the applicable
review period. Manufacture and processing for the significant new use
may not commence until EPA has conducted a review of the notice, made
an appropriate determination on the notice, and taken such actions as
are required with that determination.
Previously, in the Federal Register of April 1, 2020 (85 FR 18173;
FRL-10004-51), 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-2019-0614. That docket
includes information considered by the Agency in developing the
proposed and final rules, including public comments and EPA's responses
to the public comments received.
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.
C. How do the general SNUR provisions apply to this action?
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 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. Considerations for Significant New Use Determinations
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, and as
described in the preamble to the proposed rule, 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 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
[[Page 67998]]
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 specific 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.
IV. Public Comments on Proposed Rule and EPA Responses
EPA received three public comments on the proposed amendments. The
Agency's responses to these comments are provided in a separate
Response to Public Comments document that is available in the docket
for this rule. EPA made one change to the final rule amending 40 CFR
721.10663 based on one comment. Specifically, EPA added language used
in previous SNURs for other carbon nanotube chemicals identifying
criteria where SNUR requirements do not apply. EPA agrees with the
commenter that when the chemical substance meets any of these criteria,
there is no unreasonable risk from exposure to the substance.
V. Rationale of the Final Rule
These amendments are based on EPA's determination under 40 CFR
721.185(a)(3) following review of significant new use notices (SNUNs)
for the chemical substances submitted to EPA. After reviewing the
SNUNs, 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 during review of the SNUNs, 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 Rule 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 made this determination in issuing the original
final rule for each chemical substance, and solicited additional
comments on the proposed modifications to provide 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 and
designated April 1, 2020 (the date of publication of the proposed rule)
as the cutoff date for determining whether the new use is ongoing.
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 an applicable rule, order or consent agreement
under TSCA section 4, or a TSCA section 5(b)(4) listing covering the
chemical substance, persons are required only to submit information in
their possession or control and to describe any other information known
to or reasonably ascertainable by them (see 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).
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
[[Page 67999]]
submitters contact EPA early enough to provide time for conducting
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
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
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 under docket ID number EPA-HQ-OPPT-2019-0614.
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 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. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is not subject to Executive Order 13771 (82 FR 9339,
February 3, 2017), because this action is not a significant regulatory
action under Executive Order 12866.
C. Paperwork Reduction Act (PRA)
This action does not impose any new information collection burden
under the PRA (44 U.S.C. 3501 et seq.). Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with new
chemical SNURs have already been approved under OMB control number
2070-0012 (EPA ICR No. 0574). This action does not impose any burden
requiring additional OMB approval.
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. 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.
If an entity were to submit a SNUN to the Agency, the annual burden
is estimated to average between 30 and 170 hours per response. This
burden estimate includes the time needed to review instructions, search
existing data sources, gather and maintain the data needed, and
complete, review, and submit the required SNUN. Send any comments about
the accuracy of the burden estimate, and any suggested methods for
minimizing respondent burden, including through the use of automated
collection techniques, to the Director, 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.
D. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNUR modifications
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, EPA has concluded 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, EPA received 7 SNUNs in Federal fiscal year (FY)
2013, 13 in FY2014, 6 in FY2015, 10 in FY2016, 14 in FY2017, and 11 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.
E. 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.).
[[Page 68000]]
F. 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, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
G. Executive Order 13175: Consultation and Coordination With Indian
Tribe 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.
H. 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. EPA interprets Executive Order
13045 as applying only to those regulatory actions that concern
environmental health or safety risks that EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order.
I. 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.
J. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards and is
therefore not subject to considerations under NTTAA section 12(d) (15
U.S.C. 272 note).
K. 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).
XI. 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 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: September 14, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA amends 40
CFR part 721 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. 721.5185 by revising paragraphs (a)(1) and (a)(2)(i) and
(iii) to read as follows:
Sec. 721.5185 2-Propen-1-one, 1-(4-morpholinyl)-.
(a) * * *
(1) The chemical substance identified as 2-propen-1-one, 1-(4-
morpholinyl)- (PMN P-95-169; SNUN S-08-7; SNUN S-14-1; and SNUN S-17-
10; CAS No. 5117-12-4) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this rule do not apply to quantities of the
chemical substance after it has been completely reacted (cured) because
2-propen-1-one, 1-(4-morpholinyl)- will no longer exist.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i) and (iv), (a)(3)(i) and (ii), (a)(6)(v), (b),
and (c).
(A) Safety 4/4H EVOH/PE laminate, Ansell Edmont Neoprene number
865, and Solvex Nitrile Rubber number 275 gloves have been tested in
accordance with the American Society for Testing Materials (ASTM) F739
method and found by EPA to satisfy the consent orders and Sec.
721.63(a)(2)(i) requirements for dermal protection to 100 percent PMN
substance. Gloves and other dermal protection may not be used for a
time period longer than they are actually tested and must be replaced
at the end of each work shift. For additional dermal protection
materials, a company must submit all test data to the Agency and must
receive written Agency approval for each type of material tested prior
to use of that material as worker dermal protection. However, for the
purposes of determining the imperviousness of gloves, up to 1 year
after the commencement of commercial manufacture or import, the
employer may use the method described in Sec. 721.63(a)(3)(ii),
thereafter, they must use the method described in Sec.
721.63(a)(3)(i). For purposes of Sec. 721.63(b), the concentration is
set at 1.0%.
(B) Additional requirements for use as a monomer for
stereolithography: Requirements as specified in Sec. 721.63(a)(4) and
(5), (a)(6)(v), 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
50.
* * * * *
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1). It is a significant new use to use
the chemical substance for any use other than as a monomer for use in
ultraviolet ink jet applications or stereolithography, unless the
chemical substance is processed and used in an enclosed process.
* * * * *
0
3. Amend Sec. 721.10371 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
Sec. 721.10371 Butanoic acid, 3-mercapto-,1,1'-[2-(hydroxymethyl)-2-
(substituted-1-oxoalkoxy)methyl)-1,3-propanediyl] ester (generic).
(a) * * *
(1) The chemical substance identified generically as butanoic acid,
3-mercapto-,1,1'-[2-(hydroxymethyl)-2-(substituted-1-oxoalkoxy)methyl)-
1,3-propanediyl] ester (PMN P-10-136 and
[[Page 68001]]
S-18-5, Chemical A) 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(f). It is a significant new use to use the
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives or the confidential use described
in the significant new use notice S-18-5.
* * * * *
0
4. Amend Sec. 721.10372 by revising paragraphs (a)(1) and (a)(2)(i) to
read as follows:
Sec. 721.10372 Butanoic acid, 3-mercapto-,1,1'-[2,2-bis[(substituted-
1-oxoalkoxy)methyl]-1,3-propanediyl] ester (generic).
(a) * * *
(1) The chemical substance identified generically as butanoic acid,
3-mercapto-,1,1'-[2,2-bis[(substituted-1-oxoalkoxy)methyl]-1,3-
propanediyl] ester (PMN P-10-136 and SNUN S-18-5, Chemical B) 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(f). It is a significant new use to use the
substance other than as a monomer for acryl-based ultra-violet (UV)-
curing coatings, inks, and adhesives, or the confidential use described
in the SNUN S-18-5.
* * * * *
0
5. Amend Sec. 721.10663 by revising paragraphs (a)(1), (a)(2)(i) and
(ii), and (b)(1) to read as follows:
Sec. 721.10663 Functionalized multi-walled carbon nanotubes
(generic).
(a) * * *
(1) The chemical substance identified generically as functionalized
multi-walled carbon nanotubes (PMN P-12-44; SNUN S-18-4; and SNUN S-19-
5) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section. The requirements of
this section do not apply to quantities of the PMN substance that have
been completely reacted (cured); incorporated or embedded into a
polymer matrix that itself has been completely reacted (cured);
embedded in a permanent solid polymer form that is not intended to
undergo further processing except for mechanical process; or
incorporated into an article.
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3) through (6), (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 (NIOSH)
assigned protection factor of at least 50. For purposes of Sec.
721.63(a)(6), the airborne form of the substance includes particulate.
For purposes of Sec. 721.63(b), concentration is set at 1.0%.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(v)(1), (w)(1), and (x)(1). It is a
significant new use to use the substance other than as a chemical
additive for use in epoxy compounds for transportation, marine and
industrial coatings, paints and manufactured goods, for the
confidential use described in PMN P-12-44, or for the confidential use
described in SNUN S-19-5.
(b) * * *
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (f), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
* * * * *
0
6. Amend Sec. 721.10928 by revising paragraphs (a)(1) and (a)(2)(iii)
to read as follows:
Sec. 721.10928 Coke (coal), secondary pitch; a carbon-containing
residue from the coking of air blown pitch coke oil and/or pitch
distillate; composed primarily of isotropic carbon, it contains small
amounts of sulfur and ash constituents.
(a) * * *
(1) The chemical substance identified as coke (coal), secondary
pitch. Definition: A carbon-containing residue from the coking of air
blown pitch coke oil and/or pitch distillate; composed primarily of
isotropic carbon, it contains small amounts of sulfur and ash
constituents (PMN P-12-292, PMN P-17-217, and SNUN S-19-4; CAS No.
94113-91-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) * * *
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (p), and (y)(1) and (2). It is a
significant new use to use the substance other than for the
confidential use permitted by the Order for P-12-292, as a lubricating
agent used in the production of automotive disc brakes, or to process
as an additive for the manufacture of diesel particulate filters to
increase the porosity of the filter. It is a significant new use to use
the substance in an additive formulation to produce diesel particulate
filters within the United States. For purposes of Sec. 721.80, the
aggregate volume is 2,500,000 kilograms.
* * * * *
[FR Doc. 2020-21464 Filed 10-26-20; 8:45 am]
BILLING CODE 6560-50-P