[Federal Register Volume 86, Number 82 (Friday, April 30, 2021)]
[Proposed Rules]
[Pages 22924-22929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08883]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2020-0581; FRL-10017-51]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-2.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances which are
the subject of premanufacture notices (PMNs). This action would require
persons to notify EPA at least 90 days before commencing manufacture
(defined by statute to include import) or processing of any of these
chemical substances for an activity that is designated as a significant
new use by this proposed rule. This action would further require that
persons not commence manufacture or processing for the significant new
use until they have submitted a Significant New Use Notice (SNUN), and
EPA has conducted a review of the notice, made an appropriate
determination on the notice, and has taken any risk management actions
as are required as a result of that determination.
DATES: Comments must be received on or before June 1, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0581, using the Federal eRulemaking Portal
at https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
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.
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 proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions. This action may also affect certain entities through pre-
existing import certification and export notification rules under TSCA,
which would include the SNUR requirements should these proposed rules
be finalized. 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 proposed rule on or after June 1, 2021 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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for
chemical substances which are the subjects of PMNs P-19-82, P-20-76,
and P-20-94. These proposed SNURs would require persons who intend to
manufacture or process any of these chemical substances for an activity
that is designated as a significant new use to notify EPA at least 90
days before commencing that activity.
The record for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2020-0581, includes information considered by the Agency in
developing these proposed SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
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 rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
[[Page 22925]]
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A) (15 U.S.C. 2604(a)(1)(A)). In
particular, these requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1) (15 U.S.C. 2604(b) and
2604(d)(1)), the exemptions authorized by TSCA sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720.
Once EPA receives a SNUN, EPA must either determine that the use is not
likely to present an unreasonable risk of injury under the conditions
of use for the chemical substance or take such regulatory action as is
associated with an alternative determination before the manufacture or
processing for the significant new use can commence. If EPA determines
that the chemical substance 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
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the substances, in the context of the four bulleted
TSCA section 5(a)(2) factors listed in this unit. During its review of
these chemicals, EPA identified certain conditions of use that are not
intended by the submitters, but reasonably foreseen to occur. EPA is
proposing to designate those reasonably foreseen conditions of use as
well as certain other circumstances of use as significant new uses.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
be added to 40 CFR part 721, subpart E for the chemical substances
identified in this unit. For each chemical substance, EPA provides the
following information in this unit:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR.
Potentially useful information.
CFR citation assigned in the regulatory text section of
these proposed rules.
The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. In addition to those
conditions of use intended by the submitter, EPA has identified certain
other reasonably foreseen conditions of use. EPA has preliminarily
determined that the chemicals under their intended conditions of use
are not likely to present an unreasonable risk. However, EPA has not
assessed risks associated with the reasonably foreseen conditions of
use for these chemicals. EPA is proposing to designate these reasonably
foreseen conditions of use and other circumstances of use as
significant new uses. As a result, those significant new uses cannot
occur without first going through a separate, subsequent EPA review and
determination process associated with a SNUN.
The substances subject to these proposed rules are as follows:
PMN Number: P-19-82.
Chemical name: Heptanal, 6-hydroxy-2,6-dimethyl-.
CAS number: 62439-42-3.
Basis for action: The PMN states that the use of the substance will
be as a fragrance for scented papers, candles, detergents, cleaners,
etc. and for non-TSCA fragrance applications. Based on the physical/
chemical properties of the substance, test data on the substance, and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for aquatic toxicity,
eye irritation, reproductive toxicity, skin sensitization, and specific
target organ toxicity if the chemical is not used following the
limitations noted. This proposed SNUR designates the following as
``significant new uses'' requiring further review by EPA:
Processing the PMN substance to a concentration of greater
than or equal to 1.0% in the final end use formulation.
Release of the PMN substance resulting in surface water
concentrations that exceed 14 ppb.
Potentially useful information: EPA has determined that certain
information about the effects of the PMN substance may be potentially
useful if a manufacturer or processor is considering submitting a SNUN
for a significant new use that would be designated by this proposed
SNUR. EPA has determined that the results of aquatic toxicity,
developmental toxicity, eye irritation/corrosion, and specific target
organ toxicity testing would help characterize the potential
environmental and health effects of the PMN substance.
CFR citation: 40 CFR 721.11568.
PMN Number: P-20-76.
Chemical name: Glycine, reaction products with sodium O-iso-Pr
carbonodithioate, sodium salts.
CAS number: 2205080-23-3.
Basis for action: The PMN states that the generic use of the
substance will be as a mining chemical. Based on the physical/chemical
properties of the substance, test data on the substance, and SAR
analysis of test data on analogous substances, EPA has identified
concerns for aquatic toxicity, carcinogenicity, genetic toxicity,
reproductive toxicity, serious eye damage, skin corrosion, skin
sensitization, and specific target organ toxicity if the chemical is
not used following the limitations noted. This proposed SNUR designates
the following as ``significant new uses'' requiring further review by
EPA:
Domestic manufacture of the PMN substance.
Release of the PMN substance resulting in surface water
concentrations that exceed 21 ppb.
Potentially useful information: EPA has determined that certain
information about the effects of the PMN substance may be potentially
useful if a manufacturer or processor is considering submitting a SNUN
for a significant new use that would be designated by this proposed
SNUR. EPA has determined that the results of aquatic toxicity,
carcinogenicity, eye irritation/corrosion, genetic toxicity,
reproductive toxicity, skin sensitization, and specific target organ
toxicity testing
[[Page 22926]]
would help characterize the potential environmental and health effects
of the PMN substance.
CFR citation: 40 CFR 721.11569.
PMN Number: P-20-94.
Chemical name: Alkanedioic acid, polymer with tri-alkyl-
isocyanatocarbomonocycle, dialkylglycols, ester with 2,3-
dihydroxypropyl alkyl ester, 2-hydroxyethyl methacrylate-blocked
(generic).
CAS number: Not Available.
Basis for action: The PMN states that the use of the substance will
be as a formulation component in UV/EB coatings, inks, 3D printing/
stereolithography/additive manufacturing, and adhesive manufacturing.
Based on the physical/chemical properties of the substance and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for eye irritation,
skin irritation, and skin sensitization, if the chemical is not used
following the limitations noted. This proposed SNUR designates the
following as ``significant new uses'' requiring further review by EPA:
Use without personal protective equipment involving a
National Institute for Occupational Safety and Health (NIOSH)-certified
respirator with an Assigned Protection Factor (APF) of at least 50 (or
1,000 for spray applications), unless the substance was manufactured
with no greater than 3.5% acrylate feedstock by weight and any residual
isocyanate in the substance is present at no greater than 0.1% by
weight.
Use of the PMN substance in a consumer product.
Potentially useful information: EPA has determined that certain
information about the effects of the PMN substance may be potentially
useful if a manufacturer or processor is considering submitting a SNUN
for a significant new use that would be designated by this proposed
SNUR. EPA has determined that the results of occupational exposure
monitoring would help characterize the potential effects of the PMN
substance.
CFR citation: 40 CFR 721.11570.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV., EPA identified certain other reasonably foreseen
conditions of use, in addition to those conditions of use intended by
the submitter. EPA has preliminarily determined that the chemical under
the intended conditions of use is not likely to present an unreasonable
risk. However, EPA has not assessed risks associated with the
reasonably foreseen conditions of use. EPA is proposing to designate
these conditions of use as well as certain other circumstances of use
as significant new uses. As a result, those significant new uses cannot
occur without going through a separate, subsequent EPA review and
determination process associated with a SNUN.
B. Objectives
EPA is proposing these SNURs because the Agency wants:
To have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
To be obligated to make a determination under TSCA section
5(a)(3) regarding the use described in the SNUN, under the conditions
of use. The Agency will either determine under TSCA section 5(a)(3)(C)
that the chemical, under the conditions of use, is not likely to
present an unreasonable risk, including an unreasonable risk to a
potentially exposed or susceptible subpopulation identified as relevant
by the Administrator under the conditions of use, or make a
determination under TSCA section 5(a)(3)(A) or (B) and take the
required regulatory action associated with the determination, before
manufacture or processing for the significant new use of the chemical
substance can occur.
To be able to complete its review and determination on
each of the PMN substances, while deferring analysis on the significant
new uses proposed in these rules unless and until the Agency receives a
SNUN.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. In cases where EPA
has not received a notice of commencement (NOC) and the chemical
substance has not been added to the TSCA Inventory, no person may
commence such activities without first submitting a PMN. Therefore, for
the chemical substances subject to these proposed SNURs, EPA concludes
that the proposed significant new uses are not ongoing.
EPA designates December 4, 2020 (date of web posting of this
proposed rule) as the cutoff date for determining whether the new use
is ongoing. The objective of EPA's approach is to ensure that a person
cannot defeat a SNUR by initiating a significant new use before the
effective date of the final rule.
Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified on or after
that date would have to cease any such activity upon the effective date
of the final rule. To resume their activities, these persons would have
to first comply with all applicable SNUR notification requirements and
EPA would have to take action under section 5 allowing manufacture or
processing to proceed. In developing this proposed rule, EPA has
recognized that, given EPA's general practice of posting proposed rules
on its website a week or more in advance of Federal Register
publication, this objective could be thwarted even before Federal
Register publication of the proposed rule.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 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 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. lists potentially
useful information for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially
[[Page 22927]]
useful information identified in Unit IV. will be useful to EPA's
evaluation in the event that someone submits a SNUN for the significant
new use. Companies who are considering submitting a SNUN are
encouraged, but not required, to develop the information on the
substance, which may assist with EPA's analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data 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 which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
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, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/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 proposed 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 proposes to establish SNURs for new chemical substances
that were the subject of PMNs. 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 requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
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.
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
hereby certify that promulgation of this proposed 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 this proposed 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
[[Page 22928]]
government will be impacted by this proposed rule. As such, EPA has
determined that this proposed rule 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. 1531-1538 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
Tribal 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, as specified in Executive Order 13175 (65 FR
67249, November 9, 2000).
G. Executive Order 13045: Protection of Children From Environmental
Health 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 proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this action is not expected to affect
energy supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: November 30, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 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. Add Sec. Sec. 721.11568 through 721.11570 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec. 721.11568 Heptanal, 6-hydroxy-2,6-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as heptanal, 6-
hydroxy-2,6-dimethyl- (PMN P-19-82, CAS No. 62439-42-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to process the substance to a concentration of
greater than or equal to 1.0% in the final end use formulation.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 14.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11569 Glycine, reaction products with sodium O-iso-Pr
carbonodithioate, sodium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycine, reaction
products with sodium O-iso-Pr carbonodithioate, sodium salts (PMN P-20-
76, CAS No. 2205080-23-3) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 21.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11570 Alkanedioic acid, polymer with tri-alkyl-
isocyanatocarbomonocycle, dialkylglycols, ester with 2,3-
dihydroxypropyl alkyl ester, 2-hydroxyethyl methacrylate-blocked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
alkanedioic acid, polymer with tri-alkyl-isocyanatocarbomonocycle,
dialkylglycols, ester with 2,3-dihydroxypropyl alkyl ester, 2-
hydroxyethyl methacrylate-blocked (PMN P-20-94) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (5) and (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
[[Page 22929]]
Occupational Safety and Health assigned protection factor of at least
50 (1000 for spray application). For purposes of Sec. 721.63(a)(6),
particulate. The provisions of this section do not apply when both of
the following conditions are met: (1) The substance was manufactured
with no greater than 3.5% acrylate feedstock by weight, and (2) any
residual isocyanate in the substance is present at no greater than 0.1%
by weight.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (d), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2021-08883 Filed 4-29-21; 8:45 am]
BILLING CODE 6560-50-P