Significant New Use Rule on Certain Chemical Substances; Partial Withdrawal (PMN P-13-270), 53670-53671 [2019-21719]
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53670
Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11417
[FR Doc. 2019–21718 Filed 10–7–19; 8:45 am]
1,3-Butanediol, (3R)-.
jbell on DSK3GLQ082PROD with PROPOSALS
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,3-butanediol, (3R)- (PMN P–18–295,
CAS No. 6290–03–5) 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 721.80(f) and (g). It is a
significant new use to use the chemical
substance for other than as an ingredient
in cleaning products.
(ii) [Reserved].
(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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11418
[Reserved].
§ 721.11419
Metal oxide-chloro (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as metal oxide-chloro (PMN
P–19–113) 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 § 721.80(j). It is a significant
new use to manufacture, processing or
use of the PMN substance in a manner
that results in inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 13.
(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
§ 721.125(a) through (c), (i) and (k) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2014–0760; FRL–9998–80]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances; Partial
Withdrawal (PMN P–13–270)
Environmental Protection
Agency (EPA).
ACTION: Partial withdrawal of proposed
rule.
AGENCY:
EPA is withdrawing part of a
proposed rule, published in the Federal
Register on January 7, 2015, that
proposed significant new use rules
(SNURs) under the Toxic Substances
Control Act (TSCA) for certain chemical
substances. This withdrawal covers only
the portion of the proposed rule that
would have established a SNUR for the
chemical substance generically
described as aromatic dibenzoate, which
was the subject of premanufacture
notice (PMN) P–13–270. EPA has
received test data for this chemical
substance and based on its review is
withdrawing the proposed SNUR for the
chemical substance.
DATES: As of October 8, 2019, EPA
withdraws the proposed addition of 40
CFR 721.10735, which published in the
Federal Register of January 7, 2015 (80
FR 845) (FRL–9919–23).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0760, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
SUMMARY:
PO 00000
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For
technical information contact: Kenneth
Moss, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; 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.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Does this action apply to me?
A list of potentially affected entities is
provided in the Federal Register of
January 7, 2015 (80 FR 845) (FRL–9919–
23). If you have questions regarding the
applicability of this action to a
particular entity, consult the technical
person listed under FOR FURTHER
INFORMATION CONTACT.
II. What proposed SNUR is being
withdrawn?
In the Federal Register of January 7,
2015 (80 FR 845) (FRL–9919–23), EPA
issued proposed SNURs for 13 chemical
substances, including the chemical
substance generically described as
aromatic dibenzoate, which was the
subject of PMN P–13–270. EPA
proposed a SNUR for this PMN
substance that would designate certain
activities as significant new uses based
on a finding that the substance may
cause significant adverse environmental
effects and met the concern criteria at
§ 721.170(b)(4)(ii). The proposed SNUR
would require notification before any
use of the substance resulting in surface
water concentrations exceeding 1 part
per billion (ppb). In this Federal
Register notice, EPA is only
withdrawing the single proposed SNUR
for PMN P–13–270 (proposed to be
codified as 40 CFR 721.10735).
III. Why is that proposed SNUR being
withdrawn?
Prior to the proposed SNUR, in the
Federal Register of July 9, 2014 (79 FR
39268) (FRL–9910–01), EPA issued a
direct final SNUR on this chemical
substance in accordance with the
procedures in 40 CFR 721.160(c)(3)(i).
EPA received a notice of intent to
submit adverse comments on the direct
final SNUR, and, as required by 4 CFR
721.160(c)(3)(ii), EPA withdrew the
direct final SNUR in the Federal
Register of September 4, 2014 (79 FR
52563) (FRL–9915–69), which was
subsequently followed by the issuance
of the proposed rule in the Federal
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08OCP1
Federal Register / Vol. 84, No. 195 / Tuesday, October 8, 2019 / Proposed Rules
jbell on DSK3GLQ082PROD with PROPOSALS
Register of January 7, 2015. The record
for both the original direct final SNUR
and the direct final SNUR withdrawal
for this chemical substance was
established as docket EPA–HQ–OPPT–
2014–0166, and the record for the
subsequent proposed rule was
established as docket EPA–HQ–OPPT–
2014–0760.
Subsequent to the January 7, 2015
proposed SNUR, the PMN submitter
conducted an acute 96-hour toxicity test
in nematodes. The data were in
agreement with, and further supported
(weight-of-evidence), the Agency’s
original acute aquatic toxicity values of
no effects at saturation. The PMN
submitter also submitted an aerobic
biodegradation study that indicated that
the substance is inherently
biodegradable under aerobic conditions,
with an estimated half-life of 135 days.
Due to the low water solubility of the
PMN substance (0.004 mg/L), EPA then
recommended a chronic sediment
toxicity test as potentially useful in
evaluating the chronic exposures of the
substance in a sediment environment.
The PMN submitter conducted this
testing, which provided a sediment
chronic value of 537.4 mg/kg (geometric
mean of the no-observed and lowobserved adverse effect concentrations,
VerDate Sep<11>2014
18:28 Oct 07, 2019
Jkt 250001
or NOEC and LOEC), based on the
measurement endpoint of emergence
ratio for aquatic invertebrates. The
concentration of concern (COC) for
sediment-dwelling organisms was
calculated by EPA, using an uncertainty
factor of 10, to be 53.74 mg/kg.
Using a weight-of-evidence approach
(taking into account the low water
solubility of the substance, no adverse
effects at the substance’s saturation limit
observed in the results from the
submitted aqueous test data, and the
significant difficulty of getting the
substance into aqueous test solutions),
EPA considers the substance to have a
low (aqueous-only) environmental
hazard. Further, the Agency determined
that there is low acute and chronic
aqueous-only ecological risk for the
substance based on anticipated
manufacture, processing and use
exposure scenarios and low
environmental hazard.
EPA calculated a maximum benthic
sediment concentration of
approximately 50 mg/kg for the
substance using the Point Source
Calculator (PSC) (https://www.epa.gov/
tsca-screening-tools/point-sourcecalculator-version-105-psc-v105) aquatic
model to estimate chemical
concentrations in sediment from point
sources, with low-end receiving stream
PO 00000
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Sfmt 9990
53671
flow. This sediment concentration value
(a reasonable high-end estimate of
exposure) is below the sediment-based
COC, supporting the conclusion that the
sediment concentrations of the
substance are not expected to reach the
sediment-based COC. As a result, the
Agency also determined that the
substance does not pose a significant
environment risk to sediment-dwelling
organisms resulting from the release and
use of the substance and concludes that
the substance does not meet the criteria
under § 721.170(b).
Based on these conclusions from the
review of all available scientific
evidence, EPA is withdrawing the 2015
proposed SNUR for this chemical
substance. Copies of the data and
Agency review are available in the
docket for the proposed rule, EPA–HQ–
OPPT–2014–0760.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: September 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
[FR Doc. 2019–21719 Filed 10–7–19; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Proposed Rules]
[Pages 53670-53671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21719]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2014-0760; FRL-9998-80]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances; Partial
Withdrawal (PMN P-13-270)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Partial withdrawal of proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is withdrawing part of a proposed rule, published in the
Federal Register on January 7, 2015, that proposed significant new use
rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain
chemical substances. This withdrawal covers only the portion of the
proposed rule that would have established a SNUR for the chemical
substance generically described as aromatic dibenzoate, which was the
subject of premanufacture notice (PMN) P-13-270. EPA has received test
data for this chemical substance and based on its review is withdrawing
the proposed SNUR for the chemical substance.
DATES: As of October 8, 2019, EPA withdraws the proposed addition of 40
CFR 721.10735, which published in the Federal Register of January 7,
2015 (80 FR 845) (FRL-9919-23).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2014-0760, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; 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. Does this action apply to me?
A list of potentially affected entities is provided in the Federal
Register of January 7, 2015 (80 FR 845) (FRL-9919-23). If you have
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
II. What proposed SNUR is being withdrawn?
In the Federal Register of January 7, 2015 (80 FR 845) (FRL-9919-
23), EPA issued proposed SNURs for 13 chemical substances, including
the chemical substance generically described as aromatic dibenzoate,
which was the subject of PMN P-13-270. EPA proposed a SNUR for this PMN
substance that would designate certain activities as significant new
uses based on a finding that the substance may cause significant
adverse environmental effects and met the concern criteria at Sec.
721.170(b)(4)(ii). The proposed SNUR would require notification before
any use of the substance resulting in surface water concentrations
exceeding 1 part per billion (ppb). In this Federal Register notice,
EPA is only withdrawing the single proposed SNUR for PMN P-13-270
(proposed to be codified as 40 CFR 721.10735).
III. Why is that proposed SNUR being withdrawn?
Prior to the proposed SNUR, in the Federal Register of July 9, 2014
(79 FR 39268) (FRL-9910-01), EPA issued a direct final SNUR on this
chemical substance in accordance with the procedures in 40 CFR
721.160(c)(3)(i). EPA received a notice of intent to submit adverse
comments on the direct final SNUR, and, as required by 4 CFR
721.160(c)(3)(ii), EPA withdrew the direct final SNUR in the Federal
Register of September 4, 2014 (79 FR 52563) (FRL-9915-69), which was
subsequently followed by the issuance of the proposed rule in the
Federal
[[Page 53671]]
Register of January 7, 2015. The record for both the original direct
final SNUR and the direct final SNUR withdrawal for this chemical
substance was established as docket EPA-HQ-OPPT-2014-0166, and the
record for the subsequent proposed rule was established as docket EPA-
HQ-OPPT-2014-0760.
Subsequent to the January 7, 2015 proposed SNUR, the PMN submitter
conducted an acute 96-hour toxicity test in nematodes. The data were in
agreement with, and further supported (weight-of-evidence), the
Agency's original acute aquatic toxicity values of no effects at
saturation. The PMN submitter also submitted an aerobic biodegradation
study that indicated that the substance is inherently biodegradable
under aerobic conditions, with an estimated half-life of 135 days. Due
to the low water solubility of the PMN substance (0.004 mg/L), EPA then
recommended a chronic sediment toxicity test as potentially useful in
evaluating the chronic exposures of the substance in a sediment
environment. The PMN submitter conducted this testing, which provided a
sediment chronic value of 537.4 mg/kg (geometric mean of the no-
observed and low-observed adverse effect concentrations, or NOEC and
LOEC), based on the measurement endpoint of emergence ratio for aquatic
invertebrates. The concentration of concern (COC) for sediment-dwelling
organisms was calculated by EPA, using an uncertainty factor of 10, to
be 53.74 mg/kg.
Using a weight-of-evidence approach (taking into account the low
water solubility of the substance, no adverse effects at the
substance's saturation limit observed in the results from the submitted
aqueous test data, and the significant difficulty of getting the
substance into aqueous test solutions), EPA considers the substance to
have a low (aqueous-only) environmental hazard. Further, the Agency
determined that there is low acute and chronic aqueous-only ecological
risk for the substance based on anticipated manufacture, processing and
use exposure scenarios and low environmental hazard.
EPA calculated a maximum benthic sediment concentration of
approximately 50 mg/kg for the substance using the Point Source
Calculator (PSC) (https://www.epa.gov/tsca-screening-tools/point-source-calculator-version-105-psc-v105) aquatic model to estimate
chemical concentrations in sediment from point sources, with low-end
receiving stream flow. This sediment concentration value (a reasonable
high-end estimate of exposure) is below the sediment-based COC,
supporting the conclusion that the sediment concentrations of the
substance are not expected to reach the sediment-based COC. As a
result, the Agency also determined that the substance does not pose a
significant environment risk to sediment-dwelling organisms resulting
from the release and use of the substance and concludes that the
substance does not meet the criteria under Sec. 721.170(b).
Based on these conclusions from the review of all available
scientific evidence, EPA is withdrawing the 2015 proposed SNUR for this
chemical substance. Copies of the data and Agency review are available
in the docket for the proposed rule, EPA-HQ-OPPT-2014-0760.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2019-21719 Filed 10-7-19; 8:45 am]
BILLING CODE 6560-50-P
