Revocation of Significant New Use Rule for a Certain Chemical Substance (P-16-581), 18179-18181 [2020-06442]
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Proposed Rules
§ 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.
[EPA–HQ–OPPT–2017–0575; FRL–10005–
89]
is proposing to revoke the SNUR based
on these new data.
DATES: Comments must be received on
or before May 1, 2020.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2017–0575, by
one of the following methods:
• Federal eRulemaking Portal: 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.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Kenneth
Moss, Chemical Control Division, Office
of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: 202–
564–8974; email address:
moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
RIN 2070–AB27
SUPPLEMENTARY INFORMATION:
(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 § 721.80(f), (p)(2,500,000
kg), and (y)(1)(2). It is a significant new
use to use the substance other than (I)
for the confidential use permitted by the
TSCA Order for P–12–292, (II) as a
lubricating agent used in the production
of automotive disc brakes, or (III) 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.
*
*
*
*
*
[FR Doc. 2020–06441 Filed 3–31–20; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
Revocation of Significant New Use
Rule for a Certain Chemical Substance
(P–16–581)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to revoke
the significant new use rule (SNUR)
under the Toxic Substances Control Act
(TSCA) for the chemical substance
identified generically as alpha 1,3polysaccharide, which was the subject
of premanufacture notice (PMN)
identified as P–16–581. EPA issued a
SNUR based on this PMN which
designated certain activities as
significant new uses. EPA has received
test data for the chemical substance and
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SUMMARY:
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I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture
(including import), process, or use the
chemical substance contained in this
rule. Potentially affected entities may
include, but are not limited to:
• Manufacturers or processors of the
chemical substances (NAICS codes 325
and 324110), e.g., chemical
manufacturing and petroleum refineries.
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
PO 00000
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18179
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
40 CFR 721.5. If you have any questions
regarding the applicability of this action
to a particular entity, consult the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain
entities through pre-existing export
notification rules under TSCA. If this
proposed SNUR revocation becomes
effective, persons who export or intend
to export the chemical that is the subject
of this action would no longer be subject
to the TSCA section 12(b)(15 U.S.C.
2611(b) export notification requirements
at 40 CFR part 707 that are currently
triggered by the SNUR.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information 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/
comments.html.
II. Background
A. What action is the agency taking?
In the Federal Register of April 5,
2019 (84 FR 13531) (FRL–9991–19),
EPA promulgated a SNUR at 40 CFR
721.11193 for the chemical substance
identified generically as alpha 1,3polysaccharide (P–16–581). The SNUR
designated certain activities as
significant new uses. EPA has received
new data on the biosolubility of the
chemical substance. Based on its review
of these data, EPA now proposes to
revoke the SNUR pursuant to 40 CFR
721.185. In this unit, EPA provides a
brief description of the chemical
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS
substance, including the PMN number,
generic chemical name, the Federal
Register publication date and reference,
the docket number, the basis for
revoking the SNUR under 40 CFR
721.185, and the CFR citation of the
SNUR.
PMN Number: P–16–581
Chemical name: Alpha 1,3polysaccharide (generic).
CAS number: Not available.
Federal Register publication date
and reference: April 5, 2019 (84 FR
13531).
Basis for revocation of SNUR: EPA
issued a SNUR for this substance that
designated certain activities as
significant new uses based on a finding
that the substance may pose potential
human health hazards. Specifically,
EPA identified a concern that adverse
lung effects (i.e., lung overload) could
occur if the chemical substance were
manufactured, processed, or used in a
manner that generated respirable
particles. To address this hazard
concern, EPA issued a SNUR under
TSCA section 5(a)(2), which identified
concerns for lung effects if the following
protective measures were not followed:
(1) No use of the substance other than
the uses described in the PMN; and (2)
no manufacture, processing, or use with
particle size less than 10 micrometers.
EPA also identified pulmonary effects
toxicity testing as information
potentially useful to characterize the
health effects of the PMN substance.
The PMN submitter performed
biosolubility testing on the ground PMN
substance and provided the test data to
EPA on February 14, 2019. EPA
initiated an internal review of these
data; however, it moved forward with
publishing the final SNUR on April 5,
2019 having not yet completed its
review. The following are the results
and conclusions of the Agency’s review.
The biosolubility testing was
conducted using a conservative
respiratory tract fluid volume of 0.3 mL/
kg bw (rounded down to 20 mL for a 70
kg individual). This equated to a loading
concentration of 15 mg of the PMN
substance per mL of simulated
epithelial lung fluid (SELF). The SELF
represented the intraluminal volume of
respiratory tract fluid, without
consideration of the daily turnover
volume. The estimated average alveolar
fluid volume is approximately 37 mL,
nearly double the volume used for the
biosolubility testing. In comparison, the
normal reference range for extra
vascular lung water (EVLW) index in
humans is 7.3 ± 2.8 mL/kg bw (n = 534)
or 511 mL for a 70 kg individual. EVLW
index corresponds to the ‘‘sum of
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interstitial, intracellular, alveolar, and
lymphatic fluid, not including pleural
effusions.’’ Therefore, the solubility of
the PMN substance in SELF represented
a worst-case loading concentration for
the PMN substance in the intraluminal
compartment, assuming an equivalent
static volume of 20 mL. Given that
humans accumulate respirable, poorly
soluble particles in the intra-alveolar,
interstitial, subpleural, and bronchovascular bundle compartments, with a
predominance of particles eventually
being found in the interstitium, the
extrapolated in vitro to in vivo
concentration of the PMN substance
would equal a loading concentration of
approximately 3 mg/mL of EVLW (i.e.,
1,500 mg/(511 mL for EVLW—37 mL for
alveolar volume)) approximately 5 times
lower than the loading concentration
tested in the biosolubility study.
This information supports EPA’s
determination that the substance has
inherently low toxicity and should not
be considered a poorly soluble particle
with the associated hazard concern for
lung overload. Therefore, EPA proposes
that the SNUR for this chemical
substance be revoked pursuant to 40
CFR 721.185(a)(1).
III. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
This proposed rule would revoke or
eliminate an existing regulatory
requirement and does not contain any
new or amended requirements. As such,
the Agency has determined that this
proposed SNUR revocation would not
have any adverse impacts, economic or
otherwise.
CFR citation: 40 CFR 721.11193
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b), 5
U.S.C. 601 et seq., the Agency hereby
that this SNUR revocation would not
have a significant economic impact on
a substantial number of small entities.
This proposed rule would eliminate a
reporting requirement.
B. What is the agency’s authority for
taking this action?
Upon conclusion of the review for P–
16–581, EPA designated certain
activities as significant new uses. Under
40 CFR 721.185, EPA may at any time
revoke a SNUR for a chemical substance
which has been added to subpart E of
40 CFR part 721 if EPA makes one of the
determinations set forth in 40 CFR
721.185(a)(1) through (a)(6). Revocation
may occur on EPA’s initiative or in
response to a written request. Under 40
CFR 721.185(b)(3), if EPA concludes
that a SNUR should be revoked, the
Agency will propose the changes in the
Federal Register, briefly describe the
grounds for the action, and provide
interested parties an opportunity to
comment.
EPA has determined that the criteria
set forth in 40 CFR 721.185(a)(1) have
been satisfied for the chemical
substance. Therefore, EPA is proposing
to revoke the SNUR for this chemical
substance. The significant new use
notification and the recordkeeping
requirements at 40 CFR 721.11193
would terminate when this proposed
revocation becomes effective. In
addition, export notification under
TSCA section 12(b) and 40 CFR part
707, subpart D triggered by the SNUR
would no longer be required.
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A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
The Office of Management and Budget
(OMB) has exempted these types of
regulatory actions from review under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563, entitled (76
FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This proposed rule does not contain
any information collections subject to
approval under the PRA, (44 U.S.C.
3501 et seq.).
D. Unfunded Mandates Reform Act
(UMRA)
For the same reasons, this action does
not require any action under Title II of
UMRA (2 U.S.C. 1531–1538 et seq.).
E. Executive Order 13132: Federalism
This proposed rule does not have
Federalism implications, because it
would not have substantial direct effects
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 proposed rule does not have
Tribal implications, because it would
not have substantial direct effects on
one or more Indian Tribes, on the
relationship between the Federal
Government and Indian Tribes, or on
the distribution of power and
E:\FR\FM\01APP1.SGM
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Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Proposed Rules
responsibilities between the Federal
Government and Indian Tribes, as
specified in Executive Order (65 FR
67249, November 9, 2000).
DEPARTMENT OF DEFENSE
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
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 under Executive Order
12866, and it does not address
environmental health or safety risks
disproportionately affecting children.
48 CFR Parts 12, 19, 36, 43, and 52
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
AGENCY:
GENERAL SERVICES
ADMINISTRATION
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: March 5, 2020.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
part 721 be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
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■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
§ 721.11193
[Removed]
■ 2. Remove § 721.11193.
[FR Doc. 2020–06442 Filed 3–31–20; 8:45 am]
BILLING CODE 6560–50–P
VerDate Sep<11>2014
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Jkt 250001
[FAR Case 2018–020; Docket No. FAR–
2018–0020, Sequence No. 1]
RIN 9000–AN78
Federal Acquisition Regulation:
Construction Contract Administration
Department of Defense (DoD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Proposed rule.
DoD, GSA, and NASA are
proposing to amend the Federal
Acquisition Regulation (FAR) to
implement a section of the John S.
McCain National Defense Authorization
Act for Fiscal Year 2019, which requires
agencies to provide a notice along with
the solicitation to prospective bidders
and offerors regarding definitization of
requests for an equitable adjustment
related to change orders under
construction contracts.
DATES: Interested parties should submit
written comments to the Regulatory
Secretariat Division at one of the
addresses shown below on or before
June 1, 2020 to be considered in the
formation of the final rule.
ADDRESSES: Submit comments in
response to FAR Case 2018–020 by any
of the following methods:
• Regulations.gov: https://
www.regulations.gov. comments via the
Federal eRulemaking portal by
searching for ‘‘FAR Case 2018–020’’.
Select the link ‘‘Comment Now’’ that
corresponds with FAR Case 2018–020.
Follow the instructions provided at the
‘‘Comment Now’’ screen. Please include
your name, company name (if any), and
‘‘FAR Case 2018–020’’ on your attached
document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW,
2nd Floor, ATTN: Lois Mandell,
Washington, DC 20405.
Instructions: Please submit comments
only and cite FAR Case 2018–020, in all
correspondence related to this case.
Comments received generally will be
posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
SUMMARY:
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18181
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Ms.
Camara Francis, Procurement Analyst,
at 202–550–0935, or by email at
camara.francis@gsa.gov, for clarification
of content. For information pertaining to
status or publication schedules, contact
the Regulatory Secretariat Division at
202–501–4755. Please cite FAR Case
2018–020.
SUPPLEMENTARY INFORMATION:
I. Background
DoD, GSA, and NASA are proposing
to amend the FAR to implement section
855 of the John S. McCain National
Defense Authorization Act (NDAA) for
Fiscal Year (FY) 2019 (Pub. L. 115–232,
15 U.S.C. 644(w)). Section 855 requires
Federal agencies to provide a notice,
along with solicitations for construction
contracts anticipated to be awarded to
small businesses, to prospective offerors
including information about the
agency’s policies or practices in
complying with FAR requirements
related to the timely definitization of
requests for equitable adjustment on
construction contracts. The notice must
include data regarding the time it took
the agency to definitize requests for
equitable adjustment on construction
contracts for the three-year period
preceding the issuance of the notice.
II. Discussion and Analysis
The proposed changes to the FAR are
summarized in the following
paragraphs.
A. Solicitation notice regarding
administration of change orders for
construction. New text is proposed in
FAR part 36, Construction and
Architect-Engineer Contracts, subpart
36.5, Contract Clauses, to add coverage
of the requirement for a new solicitation
notice to be included in solicitations for
construction. Specifically, new section
36.524, Notice to offerors regarding
administration of change orders for
construction, contains the prescription
for the use of new solicitation provision
52.236–XX, Notice Regarding
Administration of Change Orders for
Construction. New section 36.524 also
includes guidance for contracting
officers regarding the information to be
inserted in the provision. This new
solicitation provision, which is
proposed to be added in FAR part 52,
Solicitation Provisions and Contract
Clauses, will provide a standardized
way for contracting officers to provide
the notice required by section 855 of the
NDAA for FY 2019.
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]]>Agencies
[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Proposed Rules]
[Pages 18179-18181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06442]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2017-0575; FRL-10005-89]
RIN 2070-AB27
Revocation of Significant New Use Rule for a Certain Chemical
Substance (P-16-581)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to revoke the significant new use rule (SNUR)
under the Toxic Substances Control Act (TSCA) for the chemical
substance identified generically as alpha 1,3-polysaccharide, which was
the subject of premanufacture notice (PMN) identified as P-16-581. EPA
issued a SNUR based on this PMN which designated certain activities as
significant new uses. EPA has received test data for the chemical
substance and is proposing to revoke the SNUR based on these new data.
DATES: Comments must be received on or before May 1, 2020.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2017-0575, by one of the following methods:
Federal eRulemaking Portal: 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.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division, Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number: 202-564-8974; 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
(including import), process, or use the chemical substance contained in
this rule. Potentially affected entities may include, but are not
limited to:
Manufacturers or processors of the chemical substances
(NAICS codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.
This action may also affect certain entities through pre-existing
export notification rules under TSCA. If this proposed SNUR revocation
becomes effective, persons who export or intend to export the chemical
that is the subject of this action would no longer be subject to the
TSCA section 12(b)(15 U.S.C. 2611(b) export notification requirements
at 40 CFR part 707 that are currently triggered by the SNUR.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information 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/comments.html.
II. Background
A. What action is the agency taking?
In the Federal Register of April 5, 2019 (84 FR 13531) (FRL-9991-
19), EPA promulgated a SNUR at 40 CFR 721.11193 for the chemical
substance identified generically as alpha 1,3-polysaccharide (P-16-
581). The SNUR designated certain activities as significant new uses.
EPA has received new data on the biosolubility of the chemical
substance. Based on its review of these data, EPA now proposes to
revoke the SNUR pursuant to 40 CFR 721.185. In this unit, EPA provides
a brief description of the chemical
[[Page 18180]]
substance, including the PMN number, generic chemical name, the Federal
Register publication date and reference, the docket number, the basis
for revoking the SNUR under 40 CFR 721.185, and the CFR citation of the
SNUR.
PMN Number: P-16-581
Chemical name: Alpha 1,3-polysaccharide (generic).
CAS number: Not available.
Federal Register publication date and reference: April 5, 2019 (84
FR 13531).
Basis for revocation of SNUR: EPA issued a SNUR for this substance
that designated certain activities as significant new uses based on a
finding that the substance may pose potential human health hazards.
Specifically, EPA identified a concern that adverse lung effects (i.e.,
lung overload) could occur if the chemical substance were manufactured,
processed, or used in a manner that generated respirable particles. To
address this hazard concern, EPA issued a SNUR under TSCA section
5(a)(2), which identified concerns for lung effects if the following
protective measures were not followed: (1) No use of the substance
other than the uses described in the PMN; and (2) no manufacture,
processing, or use with particle size less than 10 micrometers. EPA
also identified pulmonary effects toxicity testing as information
potentially useful to characterize the health effects of the PMN
substance. The PMN submitter performed biosolubility testing on the
ground PMN substance and provided the test data to EPA on February 14,
2019. EPA initiated an internal review of these data; however, it moved
forward with publishing the final SNUR on April 5, 2019 having not yet
completed its review. The following are the results and conclusions of
the Agency's review.
The biosolubility testing was conducted using a conservative
respiratory tract fluid volume of 0.3 mL/kg bw (rounded down to 20 mL
for a 70 kg individual). This equated to a loading concentration of 15
mg of the PMN substance per mL of simulated epithelial lung fluid
(SELF). The SELF represented the intraluminal volume of respiratory
tract fluid, without consideration of the daily turnover volume. The
estimated average alveolar fluid volume is approximately 37 mL, nearly
double the volume used for the biosolubility testing. In comparison,
the normal reference range for extra vascular lung water (EVLW) index
in humans is 7.3 2.8 mL/kg bw (n = 534) or 511 mL for a 70
kg individual. EVLW index corresponds to the ``sum of interstitial,
intracellular, alveolar, and lymphatic fluid, not including pleural
effusions.'' Therefore, the solubility of the PMN substance in SELF
represented a worst-case loading concentration for the PMN substance in
the intraluminal compartment, assuming an equivalent static volume of
20 mL. Given that humans accumulate respirable, poorly soluble
particles in the intra-alveolar, interstitial, subpleural, and broncho-
vascular bundle compartments, with a predominance of particles
eventually being found in the interstitium, the extrapolated in vitro
to in vivo concentration of the PMN substance would equal a loading
concentration of approximately 3 mg/mL of EVLW (i.e., 1,500 mg/(511 mL
for EVLW--37 mL for alveolar volume)) approximately 5 times lower than
the loading concentration tested in the biosolubility study.
This information supports EPA's determination that the substance
has inherently low toxicity and should not be considered a poorly
soluble particle with the associated hazard concern for lung overload.
Therefore, EPA proposes that the SNUR for this chemical substance be
revoked pursuant to 40 CFR 721.185(a)(1).
CFR citation: 40 CFR 721.11193
B. What is the agency's authority for taking this action?
Upon conclusion of the review for P-16-581, EPA designated certain
activities as significant new uses. Under 40 CFR 721.185, EPA may at
any time revoke a SNUR for a chemical substance which has been added to
subpart E of 40 CFR part 721 if EPA makes one of the determinations set
forth in 40 CFR 721.185(a)(1) through (a)(6). Revocation may occur on
EPA's initiative or in response to a written request. Under 40 CFR
721.185(b)(3), if EPA concludes that a SNUR should be revoked, the
Agency will propose the changes in the Federal Register, briefly
describe the grounds for the action, and provide interested parties an
opportunity to comment.
EPA has determined that the criteria set forth in 40 CFR
721.185(a)(1) have been satisfied for the chemical substance.
Therefore, EPA is proposing to revoke the SNUR for this chemical
substance. The significant new use notification and the recordkeeping
requirements at 40 CFR 721.11193 would terminate when this proposed
revocation becomes effective. In addition, export notification under
TSCA section 12(b) and 40 CFR part 707, subpart D triggered by the SNUR
would no longer be required.
III. 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.
This proposed rule would revoke or eliminate an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this proposed SNUR revocation
would not have any adverse impacts, economic or otherwise.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Orders 12866 (58 FR
51735, October 4, 1993) and 13563, entitled (76 FR 3821, January 21,
2011).
B. Paperwork Reduction Act (PRA)
This proposed rule does not contain any information collections
subject to approval under the PRA, (44 U.S.C. 3501 et seq.).
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b), 5 U.S.C. 601 et seq., the
Agency hereby that this SNUR revocation would not have a significant
economic impact on a substantial number of small entities. This
proposed rule would eliminate a reporting requirement.
D. Unfunded Mandates Reform Act (UMRA)
For the same reasons, this action does not require any action under
Title II of UMRA (2 U.S.C. 1531-1538 et seq.).
E. Executive Order 13132: Federalism
This proposed rule does not have Federalism implications, because
it would not have substantial direct effects 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 proposed rule does not have Tribal implications, because it
would not have substantial direct effects on one or more Indian Tribes,
on the relationship between the Federal Government and Indian Tribes,
or on the distribution of power and
[[Page 18181]]
responsibilities between the Federal Government and Indian Tribes, as
specified in Executive Order (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 under Executive Order 12866, and it 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: March 5, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
Sec. 721.11193 [Removed]
0
2. Remove Sec. 721.11193.
[FR Doc. 2020-06442 Filed 3-31-20; 8:45 am]
BILLING CODE 6560-50-P
