[Federal Register Volume 79, Number 130 (Tuesday, July 8, 2014)]
[Rules and Regulations]
[Pages 38464-38475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15874]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0277; FRL-9911-05]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 13 chemical substances
which were the subject of premanufacture notices (PMNs). Three of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
or process any of these 13 chemical substances for an activity that is
designated as a significant new use by this rule to notify EPA at least
90 days before commencing that activity. The required notification will
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.
[[Page 38465]]
DATES: This rule is effective on September 8, 2014. For purposes of
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on
July 22, 2014.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before August 7, 2014 (see Unit VI. of the SUPPLEMENTARY
INFORMATION). If EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments, on one or more
of these SNURs before August 7, 2014, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0277, by one of the following methods:
Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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 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 SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of a proposed or final rule are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. 721.20), 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 this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What action is the Agency taking?
EPA is promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are more fully set out in the preamble to EPA's first
direct final SNUR published in the Federal Register issue of April 24,
1990 (55 FR 17376). Consult that preamble for further information on
the objectives, rationale, and procedures for SNURs and on the basis
for significant new use designations, including provisions for
developing test data.
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.
[[Page 38466]]
Once EPA determines that a use of a chemical substance is a significant
new use, TSCA section 5(a)(1)(B) 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. Persons who
must report are described in Sec. 14;721.5.
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. According
to Sec. [emsp14]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). In particular, these
requirements include the information submission requirements of TSCA
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA may take regulatory action under
TSCA sections 5(e), 5(f), 6, or 7 to control the activities for which
it has received the SNUN. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
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 authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 13
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing 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 TSCA section 5(e) consent order or, the
basis for non-TSCA section 5(e) SNURs, (i.e., SNURs without TSCA
section 5(e) consent orders).
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
This rule includes two PMN substances, P-10-5 and P-11-339, whose
reported chemical names include the term ``carbon nanotube'' or
``CNT''. Because of a lack of established nomenclature for carbon
nanotubes, the TSCA Inventory names for carbon nanotubes are currently
in generic form, e.g., carbon nanotube (CNT), multi-walled carbon
nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-
walled carbon nanotube (SWCNT). EPA uses the specific structural
characteristics provided by the PMN submitter to more specifically
characterize the Inventory listing for an individual CNT. All
submitters of new chemical notices for CNTs in this SNUR have claimed
those specific structural characteristics as CBI. EPA is publishing the
generic chemical name along with the PMN number to identify that a
distinct chemical substance was the subject of the PMN without
revealing the confidential chemical identity of the PMN substance.
Confidentiality claims preclude a more detailed description of the
identity of these CNTs. If an intended manufacturer or processor of
CNTs is unsure of whether its CNTs are subject to this SNUR or any
other SNUR, the company can either contact EPA or obtain a written
determination from EPA pursuant to the bona fide procedures at Sec.
721.11. EPA is using the specific structural characteristics, for all
CNTs submitted as new chemical substances under TSCA, to help develop
standard nomenclature for placing these chemical substances on the TSCA
Inventory. EPA has compiled a generic list of those structural
characteristics entitled ``Material Characterization of Carbon
Nanotubes for Molecular Identity (MI) Determination & Nomenclature.'' A
copy of this list is available in the docket for these SNURs under
docket ID number EPA-HQ-OPPT-2014-0277. If EPA develops a more specific
generic chemical name for these materials, that name will be made
publicly available.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture volume) and other
uses designated in this rule, may be claimed as CBI. Unit IX. discusses
a procedure companies may use to ascertain whether a proposed use
constitutes a significant new use.
This rule includes 3 PMN substances (P-10-5, P-11-339 and P-12-125)
that are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``TSCA section 5(e) SNURs'' on these PMN substances are
promulgated pursuant to Sec. [emsp14]721.160, and are based on and
consistent with the provisions in the underlying consent orders. The
TSCA section 5(e) SNURs designate as a ``significant new use'' the
absence of the protective measures required in the corresponding
consent orders.
This rule also includes SNURs on 10 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in changes in exposures,
thereby constituting a ``significant new use.'' These so-called ``non-
TSCA section 5(e) SNURs'' are promulgated pursuant to Sec.
[emsp14]721.170. EPA has determined that every activity designated as a
``significant new use'' in all non-TSCA section 5(e) SNURs issued under
Sec. [emsp14]721.170 satisfies the two requirements stipulated in
Sec. 721.170(c)(2), i.e., these significant new use activities, ``(i)
are different from those described in the premanufacture notice for the
substance, including any amendments,
[[Page 38467]]
deletions, and additions of activities to the premanufacture notice,
and (ii) may be accompanied by changes in exposure or release levels
that are significant in relation to the health or environmental
concerns identified'' for the PMN substance.
PMN Number P-10-5
Chemical name: Single-walled carbon nanotubes (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: November 30,
2010.
Basis for TSCA section 5(e) consent order: The PMN states that the
uses of the substance will be as a component for a conductive coating
using the PMN substance in a dispersion or ink, and as an additive in
resins/thermoplastics/elastomers for mechanical reinforcement. Based on
structure-activity relationship (SAR) analysis of test data on
analogous respirable, poorly soluble particulates and other carbon
nanotubes (CNTs), EPA identified concerns for pulmonary toxicity,
fibrosis, carcinogenicity, mutagenicity, and immunotoxicity. Further,
available data suggests that pulmonary deposition of some
nanoparticles, including CNT may induce cardiovascular toxicity if
inhaled. Based on the uncertainty of the characterization and exposure
of nanoscale materials in general, there may be additional potential
for translocation across the dermis and effects on target organs via
the oral route of exposure. Finally, EPA expects that some fraction of
the CNTs, if released into the environment, will eventually be
suspended in water. Based on findings of sublethal effects observed for
CNTs in rainbow trout at levels as low as 100 parts per billion (ppb)
and that toxicity of CNTs may be further altered by the presence of
natural organic matter that may be associated with nanomaterials when
released into the natural environment, EPA identified concerns for
toxicity to aquatic organisms. The Order was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this
substance may present an unreasonable risk of injury to human health
and the environment. To protect against this risk, the Order requires:
1. Use of personal protective equipment including gloves and
protective clothing impervious to the substance when there is potential
dermal exposure and use of a National Institute of Occupational Safety
and Health (NIOSH)-certified air-purifying, tight-fitting full-face
respirator equipped with N-100 cartridges when there is potential
inhalation exposure.
2. Use of the substance only as a component for a conductive
coating using the PMN substance in a dispersion or ink or as an
additive in resins/thermoplastics/elastomers for mechanical
reinforcement.
3. Manufacture of the substance at a volume not to exceed a
confidential volume specified in the consent order unless the company
has submitted the results of certain health studies and physical/
chemical properties data.
4. No surface water releases of the PMN substance, except for
limited water releases resulting in no more than 1 ppb waste water
effluent concentration determined by monitoring. The Company shall
analyze the concentration of the PMN substance in waste water
discharged to the city sewer from the facility every year and adhere to
the monitoring procedure referenced in the consent order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity study in rats (OPPTS Test Guideline 870.3465 or
Organisation for Economic Co-operation and Development (OECD) Test
Guideline 413) with a post-exposure observation period of up to 3
months, including bronchoalveolar lavage fluid (BALF) analysis, a
determination of cardiovascular toxicity (clinically-based blood/plasma
protein analyses), and histopathology of the heart; and certain
physical/chemical properties, would help characterize possible effects
of the substance. The PMN submitter has agreed not to exceed the
confidential production volume stated in the consent order without
performing the inhalation toxicity study. In addition, in the consent
order, the PMN submitter agreed to provide physical/chemical properties
data within a specified time limit.
CFR citation: 40 CFR 721.10755.
PMN Number P-11-339
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: August 25, 2011.
Basis for TSCA section 5(e) consent order: The PMN states that the
use of the substance will be as an additive in resins, thermoplastics,
and elastomers for mechanical reinforcement and enhanced electrical
performance, as a coating on metallic foils for battery applications,
or in the manufacture of fabric composites. Based on SAR analysis of
test data on analogous respirable, poorly soluble particulates and
other CNTs, EPA identified concerns for pulmonary toxicity, fibrosis,
carcinogenicity, mutagenicity, and immunotoxicity. Further, available
data suggests that pulmonary deposition of some nanoparticles,
including CNT may induce cardiovascular toxicity if inhaled. Finally,
EPA expects that some fraction of the CNTs, if released into the
environment, will eventually be suspended in water. Based on findings
of sublethal effects observed for CNTs in rainbow trout at levels as
low as 100 ppb and that toxicity of CNTs may be further altered by the
presence of natural organic matter that may be associated with
nanomaterials when released into the natural environment, EPA
identified concerns for toxicity to aquatic organisms. The Order was
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on
a finding that this substance may present an unreasonable risk of
injury to human health and the environment. To protect against this
risk, the Order requires:
1. Use of personal protective equipment including gloves and
protective clothing impervious to the substance when there is potential
dermal exposure and a NIOSH-certified air-purifying, tight-fitting
full-face respirator equipped with N-100, R-100, or P-100 cartridges
when there is potential for inhalation exposure.
2. Use of the substance only as an additive in resins,
thermoplastics, and elastomers for mechanical reinforcement and
enhanced electrical performance, as a coating on metallic foils for
battery applications, or in the manufacture of fabric composites.
3. Manufacture of the substance at a volume not to exceed a
confidential volume specified in the consent order unless the company
has submitted the results of certain health studies and physical/
chemical properties data.
4. No surface water releases of the PMN substance, except for
limited water releases resulting in no more than 1 ppb waste water
effluent concentration determined by monitoring. The Company shall
analyze the concentration of the PMN substance in waste water
discharged to the city sewer from the facility every year and adhere to
the monitoring procedure referenced in the consent order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity study in rats (OPPTS Test Guideline 870.3465 or
OECD Test Guideline 413) with a post exposure observation period of up
to 3 months, including BALF analysis, a
[[Page 38468]]
determination of cardiovascular toxicity (clinically-based blood/plasma
protein analyses), and histopathology of the heart; and certain
physical/chemical properties, would help characterize possible effects
of the substance. The PMN submitter has agreed not to exceed the
confidential production volume stated in the consent order without
performing the inhalation toxicity study. In the consent order, the PMN
submitter agreed to provide physical/chemical properties data within a
specified time limit.
CFR citation: 40 CFR 721.10756.
PMN Numbers P-12-100 and P-12-150
Chemical names: Fatty acids, diesters with dihydroxy bicyclic
diether (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the uses of the substances
will be as a polymer modifier and a seal swell additive for industrial
applications. Based on test data on the PMN substances, as well as SAR
analysis of test data on analogous esters, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substances in surface waters for greater than 20 days per year.
This 20-day criterion is derived from partial life cycle tests (daphnid
chronic and fish early life stage tests) that typically range from 21
to 28 days in duration. EPA predicts toxicity to aquatic organisms may
occur if releases of the substances to surface water, from uses other
than as described in the PMNs, exceed releases from the uses described
in the PMNs. For the uses described in the PMNs, environmental releases
did not exceed 1 ppb for more than 20 days per year. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the substances may present an unreasonable risk. EPA has determined,
however, that any use of the substances other than as polymer modifiers
and seal swell additives for industrial applications may cause
significant adverse environmental effects. Based on this information,
the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.10757.
PMN Number P-12-125
Chemical name: Thermolized wasted plastic (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: October 2, 2013.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substance will be as a petroleum
feedstock. Based on SAR analysis of test data on analogous styrenes and
benzenes, EPA identified concerns for solvent irritation and solvent
neurotoxicity; hydrocarbon pneumonia; liver, kidney, blood,
developmental and reproductive toxicities; immunotoxicity,
mutagenicity, and oncogenicity. Further, polychlorinated dibenzo-p-
dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) impurities in
the PMN substance are known to be highly persistent, bioaccumulative,
and toxic (PBT) chemicals that cause developmental toxicity, inhalation
effects, carcinogenicity and are highly toxic to aquatic life. The
Order was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the substance may present an
unreasonable risk of injury to human health and the environment. To
protect against this risk, the consent order requires:
1. Establishment and use of a hazard communication program.
2. Manufacture of the PMN substance: (a) According to the chemical
composition section of the consent order, including analyzing and
reporting PCDD and PCDF levels in the PMN substance to EPA; (b) without
exceeding the maximum established limit of 110 picogram/gram (pg/g) of
PCDD/PCDF toxic equivalents (using the World Health Organization 2005
Toxic Equivalency Factors as detailed in the consent order); and (c)
while monitoring the pH of the aqueous effluent stream from the
manufacturing process as outlined in the consent order.
3. Use of the substance only as described in the consent order.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined, at this time, that there
is no testing that would help further characterize the environmental/
human health effects of the PMN substance. In the consent order, the
PMN submitter agreed to analyze for PCDD and PCDF impurities every
quarter during manufacture of the PMN substance, using EPA Test Method
8290A.
CFR citation: 40 CFR 721.10758.
PMN Number P-13-369
Chemical name: Polyphosphoric acids, esters with substituted
amines, compounds with alkyl pyridines (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance is
as a solids conglomeration additive for down-hole treatment of oil and
gas wells to prevent the undesirable production of solids. Based on
test data on the PMN substance, EPA predicts chronic toxicity to
aquatic organisms may occur at concentrations that exceed 8 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations that exceed 8 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that any
use of the substance resulting in surface water concentrations
exceeding 8 ppb or use other than as described in the PMN, or if
disposed of during manufacturing by means other than incineration may
result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a mysid
chronic toxicity test (OCSPP Test Guideline 850.1350); an algal
toxicity test (OCSPP Test Guideline 850.4500); and a modified algal
toxicity test (OCSPP Test Guideline 850.4500) where the PMN substance
is substituted for the phosphate nutrient in the algal growth medium
would help characterize the environmental effects of the PMN substance:
CFR citation: 40 CFR 721.10759.
PMN Number P-13-854
Chemical name: Zinc carboxylate salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance is
as a petroleum production chemical. Based on SAR analysis of test data
on analogous organozinc compounds, EPA predicts chronic toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations that exceed 3 ppb. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has
[[Page 38469]]
determined, however, that any use of the substance resulting in surface
water concentrations exceeding 3 ppb may result in significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10760.
PMN Numbers P-14-12, P-14-13, P-14-15, and P-14-16
Chemical names: Fatty acid amide (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the substances will be used
as emulsifiers for use in asphalt applications. Based on SAR analysis
of test data on analogous aliphatic amines, EPA predicts chronic
toxicity to aquatic organisms may occur at concentrations that exceed
the following values of the PMN substances in surface waters.
------------------------------------------------------------------------
PMN No. Concentration
------------------------------------------------------------------------
P-14-12................................ 110 ppb.
P-14-13................................ 240 ppb.
P-14-15................................ 53 ppb.
P-14-16................................ 110 ppb.
------------------------------------------------------------------------
For the use described in the PMNs, releases of the substances are
not expected to result in surface water concentrations exceeding these
values. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substances other than as emulsifiers for use in asphalt applications
may cause significant adverse environmental effects. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help characterize the
environmental effects of the PMN substance. The Agency recommends that
testing be conducted on P-14-15 as EPA predicts this substance to be
the most acutely toxic to aquatic organisms of these four PMN
substances.
CFR citation: 40 CFR 721.10761.
PMN Number P-14-60
Chemical name: 1,1'-methylenebis[isocyanatobenzene], polymer with
polycarboxylic acids in alkane polyols (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating component.
Based on SAR analysis of test data on analogous diisocyanates, EPA
identified concerns for dermal and respiratory sensitization to persons
exposed to the PMN substance. As described in the PMN, worker exposure
will be minimal due to the use of adequate personal protective
equipment, and EPA does not expect significant consumer exposure as the
substance is not used in a consumer product. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance without a NIOSH-certified
respirator with an assigned protection factor (APF) of at least 10,
where there is potential inhalation exposure; or any use of the
substance in consumer products may cause serious health effects. Based
on this information, the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a skin
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10762.
PMN Number P-14-143
Chemical name: Alkanaminium, [substituted carbomonocycle
[(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle,
carboxylate salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an ingredient used in
pigment synthesis. Based on SAR analysis of test data on analogous
delocalized cationic dyes, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb of the PMN substance in
surface waters. As described in the PMN, environmental releases are not
expected to result in surface water concentrations that exceed 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance resulting in
surface water concentrations exceeding 1 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); a fish acute toxicity mitigated by humic acid test (OPPTS
Test Guideline 850.1085); an aquatic invertebrate acute toxicity test,
freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline 850.4500) would help characterize
the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10763.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 3 of the 13
chemical substances, regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR provisions for these chemical substances are
consistent with the provisions of the TSCA section 5(e) consent orders.
These SNURs are promulgated pursuant to Sec. 721.160 (see Unit VI.).
In the other 10 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met, as discussed
in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
[[Page 38470]]
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will 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 will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
EPA will ensure that all manufacturers and processors of
the same chemical substance that is subject to a TSCA section 5(e)
consent order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the Internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. 721.160(c)(3) and Sec. 721.170(d)(4). In accordance with Sec.
721.160(c)(3)(ii) and Sec. 721.170(d)(4)(i)(B), the effective date of
this rule is September 8, 2014 without further notice, unless EPA
receives written adverse or critical comments, or notice of intent to
submit adverse or critical comments before August 7, 2014.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before August 7, 2014, EPA will withdraw the relevant sections of
this direct final rule before its effective date. EPA will then issue a
proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.
VII. Applicability of the Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this rule have
undergone premanufacture review. 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 chemical substances for
which an NOC has not been submitted, EPA concludes that the designated
significant new uses are not ongoing.
When chemical substances identified in this rule are added to the
TSCA Inventory, EPA recognizes that, before the rule is effective,
other persons might engage in a use that has been identified as a
significant new use. However, TSCA section 5(e) consent orders have
been issued for 3 of the 13 chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which would be designated as significant new uses. The
identities of all 13 of the chemical substances subject to this rule
have been claimed as confidential and EPA has received no post-PMN bona
fide submissions (per Sec. Sec. 720.25 and 721.11). Based on this, the
Agency believes that it is highly unlikely that any of the significant
new uses described in the regulatory text of this rule are ongoing.
Therefore, EPA designates July 8, 2014 as the cutoff date for
determining whether the new use is ongoing. Persons who begin
commercial manufacture or processing of the chemical substances for a
significant new use identified as of 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 wait until the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for non-TSCA section 5(e) SNURs. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. To access the OCSPP test guidelines referenced in
this document electronically, please go to http://www.epa.gov/ocspp and
select ``Test Methods and Guidelines.'' The Organisation for Economic
Co-operation and Development (OECD) test guidelines are available from
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at
http://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these chemical substances. Under recent TSCA section 5(e)
consent orders, each PMN submitter is required to submit each study
before reaching the specified production limit. Listings of the tests
specified in the TSCA section 5(e) consent orders are included in Unit
IV. The SNURs contain the same production volume limits as the TSCA
section 5(e) consent orders. Exceeding these production limits is
defined as a significant new use. Persons who intend to exceed the
production limit must notify the Agency by submitting a SNUN at least
90 days in advance of commencement of non-exempt commercial manufacture
or processing.
[[Page 38471]]
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. 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.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec. 721.11 into a single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
X. 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 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and Sec. 721.25. E-PMN software is
available electronically at http://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2014-0277.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This rule establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) consent orders. 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
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. 601 et seq.), 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 SNUR submitted by any small entity would not cost
significantly more than $8,300.
[[Page 38472]]
A copy of that certification is available in the docket for this
rule.
This 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 $8,300.
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 rule. As
such, EPA has determined that this 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. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This rule
does not significantly nor uniquely affect the communities of Indian
Tribal governments, nor does it involve or impose any requirements that
affect Indian Tribes. Accordingly, the requirements of Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000), do not apply to this
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.
H. Executive Order 13211
This action 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 section 12(d) (15 U.S.C. 272 note), 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).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: June 27, 2014.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345(d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. 9.1, add the following sections in numerical order under
the undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. 9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
* * * * *
721.10755............................................... 2070-0012
721.10756............................................... 2070-0012
721.10757............................................... 2070-0012
721.10758............................................... 2070-0012
721.10759............................................... 2070-0012
721.10760............................................... 2070-0012
721.10761............................................... 2070-0012
721.10762............................................... 2070-0012
721.10763............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
PART 721--AMENDED
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. [emsp14]721.10755 to subpart E to read as follows:
Sec. 721.10755 Single-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-10-5) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this rule do not apply to quantities
of the PMN substance after it has been completely reacted (cured);
embedded or incorporated into a
[[Page 38473]]
polymer matrix that has been reacted (cured); or embedded in a
permanent solid polymer form that is not intended to undergo further
processing except for mechanical processing.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii) (clothing that covers other exposed
areas of the arms, legs, and torso), (a)(3), (a)(4) (National Institute
for Occupational Safety and Health (NIOSH)-certified air-purifying,
tight-fitting full-face respirator equipped with N100 cartridges),
(a)(6)(i), and (c). When determining which persons are reasonably
likely to be exposed as required for Sec. 721.63(a)(1) and (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as a component for a conductive coating using the PMN substance in
a dispersion or ink, and additive in resins/thermoplastics/elastomers
for mechanical reinforcement.) and (q).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for water releases determined
by monitoring the concentration of the PMN substance in waste water
effluent according to a monitoring procedure approved for such purpose
by EPA and when the concentration of the PMN substance does not exceed
1 part per billion (ppb). EPA will review and act on written requests
to approve monitoring procedures within 90 days after such requests are
received. EPA will inform submitters of the disposition of such
requests in writing, and will explain the reasons therefore when they
are denied.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), (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 paragraphs (a)(2)(ii)
and (a)(2)(iii) of this section.
0
5. Add Sec. [emsp14]721.10756 to subpart E to read as follows:
Sec. 721.10756 Multi-walled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-11-339) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the PMN substance after it has been completely reacted
(cured); embedded or incorporated into a polymer matrix that has been
reacted (cured); or embedded in a permanent solid polymer form that is
not intended to undergo further processing except for mechanical
processing.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(2)(ii) (clothing that covers other exposed
areas of the arms, legs, and torso), (a)(3), (a)(4) (National Institute
for Occupational Safety and Health (NIOSH)-certified air-purifying,
tight-fitting full-face respirator equipped with N100, P100, or R100
cartridges), (a)(6)(i), and (c). When determining which persons are
reasonably likely to be exposed as required for Sec. 721.63(a)(1) and
(a)(4), engineering control measures (e.g., enclosure or confinement of
the operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as an additive in resins, thermoplastics, and elastomers for
mechanical reinforcement and enhanced electrical performance, as a
coating on metallic foils for battery applications, or in the
manufacture of fabric composites.) and (q).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1), except for water releases determined
by monitoring the concentration of the PMN substance in waste water
effluent according to a monitoring procedure approved for such purpose
by EPA and when the concentration of the PMN substance does not exceed
1 part per billion (ppb). EPA will review and act on written requests
to approve monitoring procedures within 90 days after such requests are
received. EPA will inform submitters of the disposition of such
requests in writing, and will explain the reasons therefore when they
are denied.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), (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 paragraphs (a)(2)(ii)
and (a)(2)(iii) of this section.
0
6. Add Sec. [emsp14]721.10757 to subpart E to read as follows:
Sec. 721.10757 Fatty acids, diesters with dihydroxy bicyclic diether
(generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acids, diesters with dihydroxy bicyclic diether (PMNs P-12-100 and P-
12-150) 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. A significant new use is any use other
than as a polymer modifier or a seal swell additive for industrial
applications.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), 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
7. Add Sec. 721.10758 to subpart E to read as follows:
Sec. 721.10758 Thermolized wasted plastic (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
thermolized wasted plastic (PMN P-12-125) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the PMN substance after
[[Page 38474]]
it has been completely fractionated, distilled, or chemically reacted
resulting in the manufacture of one or more new chemical substances
subject to PMN review or other chemical substances listed on the TSCA
Inventory.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent),
(f), (g)(1)(i) to (g)(1)(ix), (g)(2)(i) to (g)(2)(v), (g)(3)(i),
(g)(3)(ii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the TSCA section 5(e) consent order which includes
analysis and reporting and limitations of maximum levels of
polychlorinated dibenzo-p-dioxin and polychlorinated dibenzofuran
impurities and monitoring the pH of the aqueous effluent stream from
the manufacturing process as outlined in the Consent Order.)
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
8. Add Sec. [emsp14]721.10759 to subpart E to read as follows:
Sec. [emsp14]721.10759 Polyphosphoric acids, esters with substituted
amines, compounds with alkyl pyridines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyphosphoric acids, esters with substituted amines, compounds with
alkyl pyridines (PMN P-13-369) 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. A significant new use is any use of the
PMN substance other than as a solids conglomeration additive for down-
hole treatment of oil and gas wells to prevent the undesirable
production of solids.
(ii) Disposal. Requirements as specified in Sec. 721.85(a)(1).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8) (for marine discharges, a
dilution factor of 65 should be applied).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), (j), 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.
0
9. Add Sec. [emsp14]721.10760 to subpart E to read as follows:
Sec. [emsp14]721.10760 Zinc carboxylate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as zinc
carboxylate salt (PMN P-13-854) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), 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.
0
10. Add Sec. [emsp14]721.10761 to subpart E to read as follows:
Sec. [emsp14]721.10761 Fatty acid amide (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amide (PMNs P-14-12, P-14-13, P-14-15, P-14-16) 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. A significant new use is any use of the
PMN substance other than as an emulsifier for use in asphalt
applications.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), 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
11. Add Sec. [emsp14]721.10762 to subpart E to read as follows:
Sec. [emsp14]721.10762 1,1'-methylenebis[isocyanatobenzene], polymer
with polycarboxylic acids in alkane polyols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,1'-
methylenebis[isocyanatobenzene], polymer with polycarboxylic acids in
alkane polyols (PMN P-14-60) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(4), (a)(6)(i) through (a)(6)(iv), and (c). When determining
which persons are reasonably likely to be exposed as required for Sec.
721.63(a)(4), engineering control measures (e.g., enclosure or
confinement of the operation, general and local ventilation) or
administrative control measures (e.g., workplace policies and
procedures) shall be considered and implemented to prevent exposure,
where feasible. The following National Institute for Occupational
Safety and Health (NIOSH)-certified respirators with an assigned
protection factor (APF) of at least 10 meet the requirements of Sec.
721.63(a)(4):
(A) NIOSH-certified power air-purifying respirator with a hood or
helmet and with appropriate gas/vapor (acid gas, organic vapor, or
substance specific) cartridges in combination with HEPA filters;
(B) NIOSH-certified continuous flow supplied-air respirator
equipped with a loose fitting facepiece, hood, or helmet; and
(C) NIOSH-certified negative pressure (demand) supplied-air
respirator with a full facepiece.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(b) Specific requirements. The provisions of subpart A of this part
[[Page 38475]]
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
12. Add Sec. [emsp14]721.10763 to subpart E to read as follows:
Sec. [emsp14]721.10763 Alkanaminium, [substituted carbomonocycle
[(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle,
carboxylate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkanaminium, [substituted carbomonocycle
[(alkylamino)carbomonocycle]alkylene]-substituted carbomonocycle,
carboxylate salt (PMN P-14-143) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), 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.
[FR Doc. 2014-15874 Filed 7-7-14; 8:45 am]
BILLING CODE 6560-50-P