Significant New Use Rules on Certain Chemical Substances, 52179-52187 [2018-22397]
Download as PDF
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
III. Notice and Comment
IV. Ordering Paragraphs
amozie on DSK3GDR082PROD with PROPOSALS1
I. Introduction
On October 5, 2018, the Postal Service
filed a petition pursuant to 39 CFR
3050.11 requesting that the Commission
initiate a rulemaking proceeding to
consider changes to analytical
principles relating to periodic reports.1
The Petition identifies the proposed
analytical changes filed in this docket as
Proposal Eight.
II. Proposal Eight
Background. The Postal Service seeks
to modify the modeling methodology in
First-Class Mail and Marketing Mail
Letter cost models to reflect current
operational flows. Petition, Proposal
Eight at 1. The Postal Service states that
Proposal Eight relates to the
Commission’s directive in the FY 2017
Annual Compliance Determination
Report for the Postal Service to ‘‘provide
a plan to move the passthrough toward
100 percent’’ for USPS Marketing Mail
Automation Letters Barcoding.2 The
Postal Service states Proposal Eight
‘‘aligns the barcode cost avoidance and
the associated passthrough with the
Commission’s directive.’’ Id.
The Postal Service states that it
developed its current mail processing
letter cost models when cancellation
equipment had limited functionality. Id.
at 2. The outgoing primary scheme
could not isolate mail for all automated
area distribution centers (AADCs), and
mail for low volume AADCs flowed to
the outgoing secondary scheme. Id.
The Postal Service states that due to
advances in Optical Character
Recognition (OCR) technology, its
Advanced Facer Canceller System
(AFCS) is now able to read addresses
and isolate locally-processed mail from
mail destinating in the service territory
of other processing facilities. Id. This
capability eliminated the need for local
separations on outgoing primary
schemes, or the processing of prebarcoded mail on the outgoing
secondary scheme. Id. The Postal
Service states the result is an increased
quantity of mail processed on the
outgoing primary scheme. Id. at 2–3.
Proposal. The Postal Service proposes
three operational and methodological
changes: (1) Modification of models to
reflect current operational flows; (2)
correction of the exclusion of
mechanical rejects from the Input Sub
1 Petition of the United States Postal Service for
the Initiation of a Proceeding to Consider Proposed
Changes in Analytical Principles (Proposal Eight),
October 5, 2018 (Petition).
2 Id. Docket No. ACR2017, Annual Compliance
Determination Report, March 29, 2018, at 26.
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
System (ISS); and (3) removal of the
conflation of differential flows between
Output Sub System (OSS) operations
and automation barcode sortation (BCS)
operations in the Marketing Mail Letters
cost model. Id. at 3.
The Postal Service states that
modification 1 aligns the current
operational flows of automation prebarcoded Mixed AADC (MAADC) mail
with modeled automation mail. Id. at 4.
The modification changes the inflow of
10,000 pieces of modeled mail from the
outgoing secondary entry point. Id. The
Postal Service states that the
‘‘modification directly impacts only the
Automation MAADC Presort Letters and
Cards categories.’’ Id.
The Postal Service states that the
current letter models do not account for
mechanical rejects that flow to manual
operations. Id. The Postal Service states
that the delivery BCS (DBCS) Input
Output Sub System (DIOSS) reject rate
is composed of the OSS rate of rejects
flowing to manual operations. Id.
Modification 2 ‘‘corrects the DIOSS
operations’ treatment of rejects to that of
traditional OSS/ISS operations for
treatment of pieces flowing to manual
operations and to OSS operations.’’ Id.
The Postal Service suggests that the
current Marketing Mail Letters cost
model, calculating the barcode cost
avoidance as the difference between
modeled (Non-Automation) Machinable
MAADC letters and Automation
MAADC letters, ‘‘conflates the value of
the barcode with intrinsic differences
between non-barcoded and automation
mail.’’ Id. at 5. Modification 3 corrects
the model for machinable MAADC mail
by using the same down flow densities
as automation MAADC mail, ‘‘thereby
accurately estimating the value of a
barcode when used as a benchmark.’’ Id.
The Postal Service states that this
modification applies only to Marketing
Mail Letters. Id. at 6.
Rationale and impact. The Postal
Service states that it intends for the
proposal to modify the letter processing
models to reflect ‘‘current operational
reality.’’ Id. at 1. The Postal Service
states that the proposal would increase
the barcode cost avoidance of Marketing
Mail Automation MAADC letters from
$0.001 to $0.006, while reducing the
passthrough from 1300 percent to 217
percent. Id. at 6. The Postal Service
provides the change in mail processing
unit costs for Marketing Mail Letters
and First-Class Mail Letters and Cards.
Id. at 7–8.
III. Notice and Comment
The Commission establishes Docket
No. RM2019–1 for consideration of
matters raised by the Petition. More
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
52179
information on the Petition may be
accessed via the Commission’s website
at https://www.prc.gov. Interested
persons may submit comments on the
Petition and Proposal Eight no later than
November 9, 2018. Pursuant to 39
U.S.C. 505, the Commission designates
Katalin K. Clendenin as an officer of the
Commission (Public Representative) to
represent the interests of the general
public in this proceeding.
IV. Ordering Paragraphs
It is ordered:
1. The Commission establishes Docket
No. RM2019–1 for consideration of the
matters raised by the Petition of the
United States Postal Service for the
Initiation of a Proceeding to Consider
Proposed Changes in Analytical
Principles (Proposal Eight), filed
October 5, 2018.
2. Comments by interested persons in
this proceeding are due no later than
November 9, 2018.
3. Pursuant to 39 U.S.C. 505, the
Commission appoints Katalin K.
Clendenin to serve as an officer of the
Commission (Public Representative) to
represent the interests of the general
public in this docket.
4. The Secretary shall arrange for
publication of this Order in the Federal
Register.
By the Commission.
Stacy L. Ruble,
Secretary.
[FR Doc. 2018–22457 Filed 10–15–18; 8:45 am]
BILLING CODE 7710–FW–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2017–0575; FRL–9984–93]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 13
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 13 chemical
substances for an activity that is
designated as a significant new use by
this proposed rule. If this proposed rule
SUMMARY:
E:\FR\FM\16OCP1.SGM
16OCP1
52180
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
is made final, persons may not
commence manufacture or processing
for the significant new use until they
have submitted a Significant New Use
Notice, and EPA has conducted a review
of the notice, made an appropriate
determination on the notice, and has
taken any actions as are required as a
result of that determination.
DATES: Comments must be received on
or before November 15, 2018.
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 (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:
amozie on DSK3GDR082PROD with PROPOSALS1
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:
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
• 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 certification
requirements 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. Importers
of chemicals subject to these proposed
SNURs would need to certify their
compliance with 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
November 15, 2018 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/
comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) for 13 chemical
substances which were the subjects of
PMNs P–16–192, P–16–354 and P–16–
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
355, P–16–380 through P–16–385, P–
16–483 and P–16–484, P–16–575, and
P–16–581. 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 the proposed SNURs
on these chemicals was established as
docket EPA–HQ–OPPT–2017–0575.
That record includes information
considered by the Agency in developing
these proposed SNURs.
B. What is the Agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (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 bulleted TSCA
section 5(a)(2) factors listed in Unit III.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B)(i) (15
U.S.C. 2604(a)(1)(B)(i)) requires persons
to submit a significant new use notice
(SNUN) to EPA at least 90 days before
they manufacture or process the
chemical substance for that use. TSCA
prohibits such manufacturing or
processing from commencing until EPA
has conducted a review of the SNUN,
made an appropriate determination on
the SNUN, and taken such actions as are
required in association with that
determination (15 U.S.C.
2604(a)(1)(B)(ii)). As described in Unit
V., the general SNUR provisions are
found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions
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
§ 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
E:\FR\FM\16OCP1.SGM
16OCP1
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
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.
amozie on DSK3GDR082PROD with PROPOSALS1
III. Significant New Use Determination
Section 5(a)(2) of TSCA 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 addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
To determine what would constitute
significant new uses 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
conditions of use of the substances, in
the context of the four bulleted TSCA
section 5(a)(2) factors listed in this unit.
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for 13
chemical substances in 40 CFR part 721,
subpart E. In this unit, EPA provides the
following information for each chemical
substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (if assigned for nonconfidential chemical identities).
• Basis for the SNUR.
• Information identified by EPA that
would help characterize the potential
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
health and/or environmental effects of
the chemical substances if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use designated by the
SNUR.
This information may include testing
not required to be conducted but which
would help characterize the potential
health and/or environmental effects of
the PMN substance. Any
recommendation for information
identified by EPA was made based on
EPA’s consideration of available
screening-level data, if any, as well as
other available information on
appropriate testing for the chemical
substance. Further, any such testing
identified by EPA that includes testing
on vertebrates was made after
consideration of available toxicity
information, computational toxicology
and bioinformatics, and highthroughput screening methods and their
prediction models. EPA also recognizes
that whether testing/further information
is needed will depend on the specific
exposure and use scenario in the SNUN.
EPA encourages all SNUN submitters to
contact EPA to discuss any potential
future testing. See Unit VII. for more
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.
EPA has initially determined under
TSCA section 5(a)(2), 15 U.S.C.
2604(a)(2), that certain changes from the
conditions of use described in the PMNs
could result in changes in the type or
form of exposure to the chemical
substances and/or increased exposures
to the chemical substances and/or
changes in the reasonably anticipated
manner and methods of manufacturing,
processing, distribution in commerce,
and disposal of the chemical substances.
Consequently, EPA is proposing to
designate these changes as significant
new uses.
PMN Number: P–16–192
Chemical Name: Silanized
amorphous silica (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the substance will be as a
reinforcing filler for the production of
rubber goods. Based on test data for
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
52181
crystalline silica, EPA identified
concerns for lung effects if the chemical
substance is not used following the
limitations noted below. The conditions
of use of the PMN substance as
described in the PMN include the
following protective measures:
1. Manufacture of the PMN substance
in an amorphous form.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
about the physical-chemical properties
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
information about the physical form,
particle size, and water solubility would
help characterize the potential health
effects of the PMN substance.
CFR citation: 40 CFR 721.11182.
PMN Numbers: P–16–354 and P–16–355
Chemical name: Esteramine (generic).
CAS number: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as a chemical
intermediate. Based on the physical/
chemical properties of the PMN
substances and Structure Analysis
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for irritation and
developmental/reproductive toxicity,
and aquatic toxicity at surface water
concentrations exceeding 1 part per
billion (ppb), if the chemical substances
are not used following the limitations
noted below. The conditions of use of
the PMN substances as described in the
PMNs include the following protective
measures:
1. No release of a manufacturing,
processing, or use stream associated
with any use of the substances, other
than the confidential chemical
intermediate use described in the PMNs,
into the waters of the United States
exceeding a surface water concentration
of 1 ppb; and
2. No manufacturing, processing or
use of the PMN substances resulting in
inhalation exposures to the substances.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the aquatic and human health
toxicity of the PMN substances may be
potentially useful to characterize the
health and environmental effects of the
PMN substances if a manufacturer or
E:\FR\FM\16OCP1.SGM
16OCP1
52182
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
amozie on DSK3GDR082PROD with PROPOSALS1
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 specific organ toxicity and
aquatic toxicity testing would help
characterize the potential health and
environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.11183.
PMN Numbers: P–16–380, P–16–381, P–
16–382, P–16–383, P–16–384, and P–16–
385
Chemical Names: Formic acid,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
acetates (salts), (generic) (P–16–380),
propanoic acid, 2-hydroxy-, compds.
with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
formates (salts), (generic) (P–16–381),
formic acid, compds. with hydrolyzed
bisphenol A-epichlorohydrinpolyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
sulfamates (salts), (generic) (P–16–382),
formic acid, compds. with hydrolyzed
bisphenol A-epichlorohydrinpolyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
acetates (salts), (generic) (P–16–383),
propanoic acid, 2-hydroxy-, compds.
with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
formates (salts), (generic) (P–16–384),
formic acid, compds. with hydrolyzed
bisphenol A-epichlorohydrinpolyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
sulfamates (salts), (generic) (P–16–385).
CAS Numbers: Not available.
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as a component of an
electrocoat resin. Based on the physical/
chemical properties of the PMN
substances and test data on analogous
substances, EPA has identified concerns
for lung effects and toxicity to aquatic
organisms at concentrations that exceed
16 ppb if the chemical substances are
not used following the limitations noted
below. The conditions of use of the
PMN substances as described in the
PMNs include the following protective
measures:
1. No manufacturing, processing or
use of the PMN substances resulting in
inhalation exposures to the substances;
and
2. No release of a manufacturing,
processing, or use stream associated
with any use of the substances
exceeding a surface water concentration
of 16 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the health and environmental
effects of the PMN substances 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 specific target organ,
pulmonary, and acute aquatic toxicity
testing would help characterize the
potential health and environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.11184 (P–
16–380); 40 CFR 721.11185 (P–16–381);
40 CFR 721.11186 (P–16–382); 40 CFR
721.11187 (P–16–383); 40 CFR
721.11188 (P–16–384); and 40 CFR
721.11189 (P–16–385).
PMN Numbers: P–16–483 and P–16–484
Chemical names: Inorganic acids,
metal salts, compds. with modified
heteroaromatics, (generic) (P–16–483)
and Inorganic acids, metal salts,
compds. with substituted aromatic
heterocycle, (generic) (P–16–484).
CAS numbers: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of P–
16–483 will be as a plastic additive and
the generic (non-confidential) use of P–
16–484 will be as a chemical
intermediate. Based on test data
submitted on P–16–483 and data for
analogous compounds, EPA has
identified concerns for irritation,
specific organ effects, and aquatic
toxicity if the chemical is not used
following the limitations noted below.
The conditions of use of the PMN
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
substances as described in the PMNs
include the following protective
measures:
1. No use of the substances other than
the confidential use described in the
PMNs;
2. No release of a manufacturing,
processing, or use stream associated
with any use of the substances
exceeding a surface water concentration
of 34 ppb; and
3. No manufacturing, processing or
use of the PMN substances without the
engineering controls described in the
PMNs to limit exposure to dust.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental toxicity of the PMN
substances may be potentially useful to
characterize the effects of the PMN
substances 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 and specific
organ toxicity and aquatic toxicity
testing would help characterize the
potential health and environmental
effects of the PMN substances.
CFR citations: 40 CFR 721.11190 (P–
16–683) and 40 CFR 721.11191 (P–16–
684).
PMN Number: P–16–575
Chemical name: Glucosyltransferase.
International Union of Biochemistry and
Molecular Biology Number: 2.4.1.5
CAS number: 9032–14–8.
Basis for action: The PMN states that
the use of the substance will be for
polymerization of glucose. Based on the
allergenic properties of proteins and
review of surrogate enzymatic protein
data submitted, EPA has identified
concerns for respiratory sensitization if
the chemical is not used following the
limitations noted below. The conditions
of use of the PMN substance as
described in the PMN include the
following protective measure:
1. No manufacture, processing, or use
of the PMN substance that results in
inhalation exposures to the substance.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
about the workplace exposure to the
PMN substance may be potentially
useful to characterize the health effects
of the PMN substance if a manufacturer
or processor is considering submitting a
SNUN for a significant new use that
E:\FR\FM\16OCP1.SGM
16OCP1
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
would be designated by this proposed
SNUR. EPA has determined that the
results of workplace air monitoring
would help characterize the potential
health effects of the PMN substance.
CFR citation: 40 CFR 721.11192.
PMN Number: P–16–581
Chemical name: Alpha 1,3polysaccharide (generic).
CAS number: Not available.
Basis for action: The PMN states that
the uses of the substance will be as a
polymer additive, paper coating
component, composite component, and
fiber additive. Based on analogy to high
molecular weight polymers, EPA has
identified concerns for lung effects if the
chemical is not used following the
limitations noted below. The conditions
of use of the PMN substance as
described in the PMN include the
following protective measures:
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.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
about the toxicity of the PMN substance
may be potentially useful to characterize
the health effects of the PMN substance
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
pulmonary effects toxicity testing of the
PMN substance may be potentially
useful in characterizing the health
effects of the PMN substance.
CFR citation: 40 CFR 721.11193.
V. Rationale and Objectives of the
Proposed Rule
amozie on DSK3GDR082PROD with PROPOSALS1
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 reasonably foreseen
changes from the conditions of use
identified in the PMNs and determined
that those changes could result in
changes in the type or form of exposure
to the chemical substances and/or
increased exposures to the chemical
substances and/or changes in the
reasonably anticipated manner and
methods of manufacturing, processing,
distribution in commerce, and disposal
of the chemical substances.
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
B. Objectives
EPA is proposing SNURs for 13
specific chemical substances which are
undergoing premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses that would be
designated in this proposed rule:
• EPA would 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.
• EPA would 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
section 5(a)(3)(C) that the significant
new 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
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.
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/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
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 this proposed
SNUR, EPA concludes that the proposed
significant new uses are not ongoing.
EPA designates October 10, 2018, 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
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
52183
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.
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 (15 U.S.C. 2603), then
TSCA section 5(b)(1)(A) (15 U.S.C.
2604(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 § 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 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
E:\FR\FM\16OCP1.SGM
16OCP1
52184
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
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 section 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.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VIII. SNUN Submissions
According to § 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
§ 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 § 720.40 and
§ 721.25. E–PMN software is available
electronically at https://www.epa.gov/
reviewing-new-chemicals-under-toxicsubstances-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 under docket ID number EPA–
HQ–OPPT–2017–0575.
X. Statutory and Executive Order
Reviews
amozie on DSK3GDR082PROD with PROPOSALS1
A. Executive Order 12866
This proposed rule would establish
SNURs for 13 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
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993).
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
B. Paperwork Reduction Act (PRA)
According to 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, Collection
Strategies Division, Office of
Environmental Information (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)
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (5 U.S.C.
605(b)), that promulgation of a SNUR
does not have a significant economic
impact on a substantial number of small
entities where the following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small
entity would not cost significantly more
than $9,816.
A copy of that certification is
available in the docket for this action.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the Economic
Analysis discussed in Unit XI. and
EPA’s experience promulgating SNURs
(discussed in the certification), EPA
believes that the following are true:
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $9.816.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
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. 1502, 1503, 1504, or 1505 et
seq.).
E. Executive Order 13132
This action would 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).
F. Executive Order 13175
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would 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,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (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.
E:\FR\FM\16OCP1.SGM
16OCP1
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
H. Executive Order 13211
This proposed rule is not subject to
Executive Order 13211, entitled
‘‘Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (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 § 12(d) (Pub. L. 104–113, 12(d)),
does not apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: October 5, 2018.
Tala R. Henry,
Acting Director, Office of Pollution Prevention
and Toxics.
Therefore, it is proposed that 40 CFR
part 721 is amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.11182 to subpart E to
read as follows:
■
amozie on DSK3GDR082PROD with PROPOSALS1
§ 721.11182
(generic).
Silanized amorphous silica
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as silanized
amorphous silica (P–16–192) 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. It is a significant
new use to manufacture the substance
other than in an amorphous form.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
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.
■ 3. Add § 721.11183 to subpart E to
read as follows:
§ 721.11183
Esteramine (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances
identified generically as esteramine
(PMN P–16–354 and P–16–355) are
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. It is a significant
new use to manufacture, process, or use
the substances in any manner that
results in inhalation exposure. It is a
significant new use to release a
manufacturing, processing, or use
stream associated with any use of the
substances, other than the confidential
chemical intermediate use described in
the premanufacture notices, into the
waters of the United States exceeding a
surface water concentration of 1 part per
billion (ppb) using the methods
described in § 721.91.
(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) though (e), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 4. Add § 721.11184 to subpart E to
read as follows:
§ 721.11184 Formic acid, compds. with
hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
acetates (salts), (generic)
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as formic acid,
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
52185
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
acetates (salts), (P–16–380) 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. It is a significant
new use to manufacture, process, or use
the substance in any 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 = 16.
(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
provisions of § 721.185 apply to this
section.
■ 5. Add § 721.11185 to subpart E to
read as follows:
§ 721.11185 Propanoic acid, 2-hydroxy-,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether
with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
formates (salts), (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically as propanoic acid, 2hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrinpolyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
formates (salts), (P–16–381) 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. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposure.
E:\FR\FM\16OCP1.SGM
16OCP1
52186
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / Proposed Rules
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 16.
(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
provisions of § 721.185 apply to this
section.
■ 6. Add § 721.11186 to subpart E to
read as follows:
amozie on DSK3GDR082PROD with PROPOSALS1
§ 721.11186 Formic acid, compds. with
hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde2-(methylamino)ethanol reaction products
sulfamates (salts), (generic),
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as formic acid,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
sulfamates (salts), (P–16–382) 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. It is a significant
new use to manufacture, process, or use
the substance in any 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 = 16.
(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
provisions of § 721.185 apply to this
section.
■ 7. Add § 721.11187 to subpart E to
read as follows:
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
§ 721.11187 Formic acid, compds. with
hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde2-(methylamino)ethanol reaction products
acetates (salts), (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as formic acid,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
acetates (salts), (P–16–383) 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. It is a significant
new use to manufacture, process, or use
the substance in any 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 = 16.
(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
provisions of § 721.185 apply to this
section.
■ 8. Add § 721.11188 to subpart E to
read as follows:
§ 721.11188 Propanoic acid, 2-hydroxy-,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol ether
with bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
formates (salts), (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as propanoic acid,
2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrinpolyethylene glycol ether with
bisphenol A (2:1) polymer-N1-(1,3dimethylbutylidene)-N2-[2-[(1, 3dimethylbutylidene)amino] ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
formates (salts), (P–16–384) 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. It is a significant
new use to manufacture, process, or use
the substance in any 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 = 16.
(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
provisions of § 721.185 apply to this
section.
■ 9. Add § 721.11189 to subpart E to
read as follows:
§ 721.11189 Formic acid, compds. with
hydrolyzed bisphenol A-epichlorohydrinpolyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde2-(methylamino)ethanol reaction products
sulfamates (salts), (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance
generically identified as formic acid,
compds. with hydrolyzed bisphenol Aepichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymerN1-(1,3-dimethylbutylidene)-N2-[2-[(1,
3-dimethylbutylidene)amino]ethyl]-1,2ethanediamine-dialdehyde-2(methylamino)ethanol reaction products
sulfamates (salts), (P–16–385) 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. It is a significant
new use to manufacture, process, or use
the substance in any 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 = 16.
(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
E:\FR\FM\16OCP1.SGM
16OCP1
Federal Register / Vol. 83, No. 200 / Tuesday, October 16, 2018 / 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.
■ 10. Add § 721.11190 to subpart E to
read as follows:
§ 721.11190 Inorganic acids, metal salts,
compds. with modified heteroaromatics,
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as inorganic acids, metal
salts, compds. with modified
heteroaromatics, (PMN P–16–483) 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, process, or use
the substance without the engineering
controls described in the
premanufacture notice to limit exposure
to dust.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 34 ppb.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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.
■ 11. Add § 721.11191 to subpart E to
read as follows:
§ 721.11191 Inorganic acids, metal salts,
compds. with substituted aromatic
heterocycle, (generic).
amozie on DSK3GDR082PROD with PROPOSALS1
(a) Chemical substance and
significant new uses subject to reporting.
VerDate Sep<11>2014
17:27 Oct 15, 2018
Jkt 247001
(1) The chemical substance identified
generically as inorganic acids, metal
salts, compds. with substituted aromatic
heterocycle, (PMN P–16–484) 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, process, or use
the substance without the engineering
controls described in the
premanufacture to limit exposure to
dust.
(ii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) where N = 34.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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.
■ 12. Add § 721.11192 to subpart E to
read as follows:
§ 721.11192 Glucosyltransferase,
International Union of Biochemistry and
Molecular Biology Number: 2.4.1.5.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
as glucosyltransferase, International
Union of Biochemistry and Molecular
Biology Number: 2.4.1.5 (PMN P–16–
575, CAS No. 9032–14–8) 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(y)(1) and (y)(2).
(ii) [Reserved]
PO 00000
Frm 00017
Fmt 4702
Sfmt 9990
52187
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 13. Add § 721.11193 to subpart E to
read as follows:
§ 721.11193
(generic).
Alpha 1,3-polysaccharide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alpha 1,3-polysaccharide
(generic) (PMN P–16–581) 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. It is a significant
new use to use the substance other than
as a polymer additive, paper coating
component, composite component, or
fiber additive. It is a significant new use
to manufacture, process or use the PMN
substance with particle size less than 10
micrometers.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2018–22397 Filed 10–15–18; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\16OCP1.SGM
16OCP1
Agencies
[Federal Register Volume 83, Number 200 (Tuesday, October 16, 2018)]
[Proposed Rules]
[Pages 52179-52187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22397]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2017-0575; FRL-9984-93]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 13 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 13 chemical substances for an activity that is designated as a
significant new use by this proposed rule. If this proposed rule
[[Page 52180]]
is made final, persons may not commence manufacture or processing for
the significant new use until they have submitted a Significant New Use
Notice, and EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken any actions as
are required as a result of that determination.
DATES: Comments must be received on or before November 15, 2018.
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 (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. 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
certification requirements 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. Importers of chemicals subject to these proposed SNURs
would need to certify their compliance with 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 November 15, 2018 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/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for 13
chemical substances which were the subjects of PMNs P-16-192, P-16-354
and P-16-355, P-16-380 through P-16-385, P-16-483 and P-16-484, P-16-
575, and P-16-581. 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 the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2017-0575. That record includes
information considered by the Agency in developing these proposed
SNURs.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (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 bulleted TSCA section 5(a)(2)
factors listed in Unit III. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)(i)
(15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use. TSCA prohibits such
manufacturing or processing from commencing until EPA has conducted a
review of the SNUN, made an appropriate determination on the SNUN, and
taken such actions as are required in association with that
determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V.,
the general SNUR provisions are found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions
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
Sec. 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
[[Page 52181]]
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
Section 5(a)(2) of TSCA 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 addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute significant new uses 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 conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 13 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
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.
Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information identified by EPA was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VII. for more 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. EPA has initially
determined under TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), that
certain changes from the conditions of use described in the PMNs could
result in changes in the type or form of exposure to the chemical
substances and/or increased exposures to the chemical substances and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substances. Consequently, EPA is proposing to designate
these changes as significant new uses.
PMN Number: P-16-192
Chemical Name: Silanized amorphous silica (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the substance will
be as a reinforcing filler for the production of rubber goods. Based on
test data for crystalline silica, EPA identified concerns for lung
effects if the chemical substance is not used following the limitations
noted below. The conditions of use of the PMN substance as described in
the PMN include the following protective measures:
1. Manufacture of the PMN substance in an amorphous form.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information about the physical-chemical properties 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 information about the
physical form, particle size, and water solubility would help
characterize the potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11182.
PMN Numbers: P-16-354 and P-16-355
Chemical name: Esteramine (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a chemical intermediate.
Based on the physical/chemical properties of the PMN substances and
Structure Analysis Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for irritation and
developmental/reproductive toxicity, and aquatic toxicity at surface
water concentrations exceeding 1 part per billion (ppb), if the
chemical substances are not used following the limitations noted below.
The conditions of use of the PMN substances as described in the PMNs
include the following protective measures:
1. No release of a manufacturing, processing, or use stream
associated with any use of the substances, other than the confidential
chemical intermediate use described in the PMNs, into the waters of the
United States exceeding a surface water concentration of 1 ppb; and
2. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the aquatic and human health toxicity of the PMN
substances may be potentially useful to characterize the health and
environmental effects of the PMN substances if a manufacturer or
[[Page 52182]]
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 specific organ toxicity and aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substances.
CFR citation: 40 CFR 721.11183.
PMN Numbers: P-16-380, P-16-381, P-16-382, P-16-383, P-16-384, and P-
16-385
Chemical Names: Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-380), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-381), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-382), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino] ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic) (P-
16-383), propanoic acid, 2-hydroxy-, compds. with hydrolyzed bisphenol
A-epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic) (P-
16-384), formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (generic)
(P-16-385).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as a component of an
electrocoat resin. Based on the physical/chemical properties of the PMN
substances and test data on analogous substances, EPA has identified
concerns for lung effects and toxicity to aquatic organisms at
concentrations that exceed 16 ppb if the chemical substances are not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:
1. No manufacturing, processing or use of the PMN substances
resulting in inhalation exposures to the substances; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 16 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substances 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 specific target organ, pulmonary, and acute aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substances.
CFR citation: 40 CFR 721.11184 (P-16-380); 40 CFR 721.11185 (P-16-
381); 40 CFR 721.11186 (P-16-382); 40 CFR 721.11187 (P-16-383); 40 CFR
721.11188 (P-16-384); and 40 CFR 721.11189 (P-16-385).
PMN Numbers: P-16-483 and P-16-484
Chemical names: Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic) (P-16-483) and Inorganic acids, metal salts,
compds. with substituted aromatic heterocycle, (generic) (P-16-484).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of P-16-483 will be as a plastic additive and the
generic (non-confidential) use of P-16-484 will be as a chemical
intermediate. Based on test data submitted on P-16-483 and data for
analogous compounds, EPA has identified concerns for irritation,
specific organ effects, and aquatic toxicity if the chemical is not
used following the limitations noted below. The conditions of use of
the PMN substances as described in the PMNs include the following
protective measures:
1. No use of the substances other than the confidential use
described in the PMNs;
2. No release of a manufacturing, processing, or use stream
associated with any use of the substances exceeding a surface water
concentration of 34 ppb; and
3. No manufacturing, processing or use of the PMN substances
without the engineering controls described in the PMNs to limit
exposure to dust.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substances may be potentially useful to characterize the effects of
the PMN substances 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 and specific organ toxicity and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
PMN substances.
CFR citations: 40 CFR 721.11190 (P-16-683) and 40 CFR 721.11191 (P-
16-684).
PMN Number: P-16-575
Chemical name: Glucosyltransferase. International Union of
Biochemistry and Molecular Biology Number: 2.4.1.5
CAS number: 9032-14-8.
Basis for action: The PMN states that the use of the substance will
be for polymerization of glucose. Based on the allergenic properties of
proteins and review of surrogate enzymatic protein data submitted, EPA
has identified concerns for respiratory sensitization if the chemical
is not used following the limitations noted below. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
1. No manufacture, processing, or use of the PMN substance that
results in inhalation exposures to the substance.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information about the workplace exposure to the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer or processor is considering submitting a
SNUN for a significant new use that
[[Page 52183]]
would be designated by this proposed SNUR. EPA has determined that the
results of workplace air monitoring would help characterize the
potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11192.
PMN Number: P-16-581
Chemical name: Alpha 1,3-polysaccharide (generic).
CAS number: Not available.
Basis for action: The PMN states that the uses of the substance
will be as a polymer additive, paper coating component, composite
component, and fiber additive. Based on analogy to high molecular
weight polymers, EPA has identified concerns for lung effects if the
chemical is not used following the limitations noted below. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
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.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the toxicity of the PMN substance may be potentially
useful to characterize the health effects of the PMN substance 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 pulmonary effects toxicity testing
of the PMN substance may be potentially useful in characterizing the
health effects of the PMN substance.
CFR citation: 40 CFR 721.11193.
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 reasonably foreseen changes from the
conditions of use identified in the PMNs and determined that those
changes could result in changes in the type or form of exposure to the
chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances.
B. Objectives
EPA is proposing SNURs for 13 specific chemical substances which
are undergoing premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses that would be designated in this proposed rule:
EPA would 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.
EPA would 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 section
5(a)(3)(C) that the significant new 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 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.
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/opptintr/existingchemicals/pubs/tscainventory/.
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 this proposed SNUR, EPA concludes
that the proposed significant new uses are not ongoing.
EPA designates October 10, 2018, 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.
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 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(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
Sec. 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 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
[[Page 52184]]
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 section 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.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VIII. SNUN Submissions
According to Sec. 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 Sec. 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 Sec. 720.40 and Sec. 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 under docket ID number EPA-HQ-OPPT-
2017-0575.
X. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for 13 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 Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to 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,
Collection Strategies Division, Office of Environmental Information
(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)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 605(b)), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUN submitted by any small entity would not cost
significantly more than $9,816.
A copy of that certification is available in the docket for this
action.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $9.816.
Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this 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. 1502, 1503, 1504, or 1505
et seq.).
E. Executive Order 13132
This action would 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).
F. Executive Order 13175
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would 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, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (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.
[[Page 52185]]
H. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitled ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (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 Sec. 12(d) (Pub. L. 104-113, 12(d)), does not apply
to this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 5, 2018.
Tala R. Henry,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 is 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).
0
2. Add Sec. 721.11182 to subpart E to read as follows:
Sec. 721.11182 Silanized amorphous silica (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as silanized
amorphous silica (P-16-192) 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. It is a significant new use to
manufacture the substance other than in an amorphous form.
(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 Sec.
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 Sec. 721.185 apply to this section.
0
3. Add Sec. 721.11183 to subpart E to read as follows:
Sec. 721.11183 Esteramine (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substances identified generically as esteramine
(PMN P-16-354 and P-16-355) are 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. It is a significant new use to
manufacture, process, or use the substances in any manner that results
in inhalation exposure. It is a significant new use to release a
manufacturing, processing, or use stream associated with any use of the
substances, other than the confidential chemical intermediate use
described in the premanufacture notices, into the waters of the United
States exceeding a surface water concentration of 1 part per billion
(ppb) using the methods described in Sec. 721.91.
(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 Sec.
721.125(a) though (e), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
4. Add Sec. 721.11184 to subpart E to read as follows:
Sec. 721.11184 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (generic)
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (P-16-380) 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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. Add Sec. 721.11185 to subpart E to read as follows:
Sec. 721.11185 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene) amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically as propanoic acid, 2-
hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
formates (salts), (P-16-381) 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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
[[Page 52186]]
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. 721.11186 to subpart E to read as follows:
Sec. 721.11186 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products sulfamates (salts), (generic),
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (P-16-382)
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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. 721.11187 to subpart E to read as follows:
Sec. 721.11187 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products acetates (salts), (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products acetates (salts), (P-16-383) 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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
8. Add Sec. 721.11188 to subpart E to read as follows:
Sec. 721.11188 Propanoic acid, 2-hydroxy-, compds. with hydrolyzed
bisphenol A-epichlorohydrin-polyethylene glycol ether with bisphenol A
(2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-
dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products formates (salts), (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as propanoic
acid, 2-hydroxy-, compds. with hydrolyzed bisphenol A-epichlorohydrin-
polyethylene glycol ether with bisphenol A (2:1) polymer-N1-(1,3-
dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)amino] ethyl]-1,2-
ethanediamine-dialdehyde-2-(methylamino)ethanol reaction products
formates (salts), (P-16-384) 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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. Add Sec. 721.11189 to subpart E to read as follows:
Sec. 721.11189 Formic acid, compds. with hydrolyzed bisphenol A-
epichlorohydrin-polyethylene glycol ether with bisphenol A (2:1)
polymer-N1-(1,3-dimethylbutylidene)-N2-[2-[(1, 3-dimethylbutylidene)
amino]ethyl]-1,2-ethanediamine-dialdehyde-2-(methylamino)ethanol
reaction products sulfamates (salts), (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance generically identified as formic acid,
compds. with hydrolyzed bisphenol A-epichlorohydrin-polyethylene glycol
ether with bisphenol A (2:1) polymer-N1-(1,3-dimethylbutylidene)-N2-[2-
[(1, 3-dimethylbutylidene)amino]ethyl]-1,2-ethanediamine-dialdehyde-2-
(methylamino)ethanol reaction products sulfamates (salts), (P-16-385)
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. It is a significant new use to
manufacture, process, or use the substance in any manner that results
in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 16.
(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
[[Page 52187]]
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
10. Add Sec. 721.11190 to subpart E to read as follows:
Sec. 721.11190 Inorganic acids, metal salts, compds. with modified
heteroaromatics, (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
inorganic acids, metal salts, compds. with modified heteroaromatics,
(PMN P-16-483) 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(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the premanufacture notice to limit exposure to
dust.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 34 ppb.
(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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725 (b)(1) apply to paragraph (a)(2)(i) of
this section.
0
11. Add Sec. 721.11191 to subpart E to read as follows:
Sec. 721.11191 Inorganic acids, metal salts, compds. with substituted
aromatic heterocycle, (generic).
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified generically as inorganic
acids, metal salts, compds. with substituted aromatic heterocycle, (PMN
P-16-484) 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(j). It is a significant new use to
manufacture, process, or use the substance without the engineering
controls described in the premanufacture to limit exposure to dust.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 34.
(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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
0
12. Add Sec. 721.11192 to subpart E to read as follows:
Sec. 721.11192 Glucosyltransferase, International Union of
Biochemistry and Molecular Biology Number: 2.4.1.5.
(a) Chemical substance and significant new uses subject to
reporting.
(1) The chemical substance identified as glucosyltransferase,
International Union of Biochemistry and Molecular Biology Number:
2.4.1.5 (PMN P-16-575, CAS No. 9032-14-8) 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(y)(1) and (y)(2).
(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 Sec.
721.125(a) through (c), 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.
0
13. Add Sec. 721.11193 to subpart E to read as follows:
Sec. 721.11193 Alpha 1,3-polysaccharide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alpha
1,3-polysaccharide (generic) (PMN P-16-581) 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. It is a significant new use to use the
substance other than as a polymer additive, paper coating component,
composite component, or fiber additive. It is a significant new use to
manufacture, process or use the PMN substance with particle size less
than 10 micrometers.
(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 Sec.
721.125(a) through (c) 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. 2018-22397 Filed 10-15-18; 8:45 am]
BILLING CODE 6560-50-P