Significant New Use Rule on Certain Chemical Substances, 26644-26649 [2017-11695]
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26644
Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Proposed Rules
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
however, based on the structural
similarity between tolfenpyrad and PT–
CA, it is anticipated that the
multiresidue method protocols would
not be suitable for analysis of PT–CA.
Contact: RD.
9. PP 6E8450. (EPA–HQ–OPP–2016–
0519). Interregional Research Project
No. 4 (IR–4) Project Headquarters,
Rutgers, The State University of New
Jersey, 500 College Road East, Suite
201W, Princeton, NJ 08540, requests to
establish tolerances in 40 CFR part
180.614 for residues of the bactericide,
Kasugamycin, (3–O-[2-amino-4[(carboxyimino-methyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol) in or on Fruit, stone,
subgroup 12–12A at 0.6 parts per
million (ppm) and Walnut at 0.04 ppm.
The Analytical Method, Meth-146,
Revision #4 is used to measure and
evaluate the chemical kasugamycin.
Contact: RD.
New Tolerance Exemptions for NonInerts (Except PIPS)
PP 6F8520. (EPA–HQ–OPP–2017–
0080). Monsanto Company, 1300 I (Eye)
St. NW., Suite 450 East, Washington, DC
20005, requests to establish an
exemption from the requirement of a
tolerance in 40 CFR part 180 for
residues of the plant growth regulator
LCO SP104: D-Glucose,O–2-deoxy-2[[(11Z)-1-oxo-11-octadecen-1-yl]amino]b-D-glucopyranosyl-(1→4)-O–2(acetylamino)-2-deoxy-b-Dglucopyranosyl-(1→4)-O–2(acetylamino)-2-deoxy-b-Dglucopyranosyl-(1→4)-O–2(acetylamino)- 2-deoxy-b-Dglucopyranosyl-(1→4)-2-(acetylamino)2-deoxy- in or on raw agricultural
commodities and processed foods. The
petitioner believes no analytical method
is needed because analytical methods
normally utilized for detection of
compounds in crop plants are incapable
of quantifying the negligible levels of
LCO SP104 that are predicted to be
presented in raw or processed
agricultural commodities. Even in the
unlikely event that dietary exposure
does occur associated with the
requested uses, the demonstrated
favorable toxicological profile for LCO
SP104 does not present a potential
hazard for humans or the environment.
Contact: BPPD.
New Tolerance Exemptions for PIPS
1. PP 6F8541. (EPA–HQ–OPP–2017–
0113). Bayer CropScience LP, 2 T.W.
Alexander Dr., Research Triangle Park,
NC 27709, requests to establish an
exemption from the requirement of a
tolerance in 40 CFR part 174 for
residues of the plant-incorporated
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protectant (PIP) Bacillus thuringiensis
Cry14Ab-1 protein in or on soybean.
The petitioner believes no analytical
method is needed because this petition
is for a temporary exemption from the
requirement of a tolerance without
numerical limitation; thus, an analytical
method should not be required. Contact:
BPPD.
2. PP IN–11022 (EPA–HQ–OPP–2017–
0115). Bayer CropScience LP, 2 T.W.
Alexander Dr., Research Triangle Park,
NC 27709, requests to establish an
exemption from the requirement of a
tolerance in 40 CFR part 174 for
residues of the plant-incorporated
protectant (PIP) inert ingredient 4hydroxyphenyl pyruvate deoxygenase
(HPPD–4) in or on all food commodities.
The petitioner believes no analytical
method is needed because this petition
is for a temporary exemption from the
requirement of a tolerance without
numerical limitation; thus, an analytical
method should not be required. Contact:
BPPD.
Authority: 21 U.S.C. 346a.
Dated: April 27, 2017.
Delores Barber,
Director, Information Technology and
Resources Management Division, Office of
Pesticide Programs.
[FR Doc. 2017–11927 Filed 6–7–17; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2016–0207; FRL–9959–37]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing a significant
new use rule (SNUR) under the Toxic
Substances Control Act (TSCA) for one
chemical substance that was the subject
of a premanufacture notice (PMN). The
applicable review period for the PMN
submitted for this chemical substance
ended prior to June 22, 2016, the date
on which President Obama signed into
law the Frank R. Lautenberg Chemical
Safety for the 21st Century Act (which
amends TSCA). This action would
require persons who intend to
manufacture (defined by statute to
include import) or process the chemical
substance for an activity that is
designated as a significant new use by
this proposed rule to notify EPA at least
SUMMARY:
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90 days before commencing that
activity. The required notification
initiates EPA’s evaluation of the
intended use within the applicable
review period. Manufacture and
processing for the significant new use is
unable to commence until EPA has
conducted a review of the notice, made
an appropriate determination on the
notice, and take such actions as are
required with that determination.
DATES: Comments must be received on
or before July 10, 2017.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0207, 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:
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 substance 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
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determine whether this document
applies to them. Potentially affected
entities may include:
Manufacturers (including importers)
or processors of the subject chemical
substance (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 to
a proposed or final rule are subject to
the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b))
(see § 721.20), and must comply with
the export notification requirements in
40 CFR part 707, subpart D.
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B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing this SNUR under
TSCA section 5(a)(2) for the chemical
substance that was the subject of PMN
P–11–482. This SNUR would require
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persons who intend to manufacture or
process this chemical substance for an
activity that is designated as a
significant new use to notify EPA at
least 90 days before commencing that
activity. In accordance with the
procedures at § 721.160(c)(3)(i), in the
Federal Register publication of
November 17, 2016 (81 FR 81250) (FRL–
9953–41) EPA issued a direct final
SNUR on this chemical substance,
which is the subject of a PMN. EPA
received a notice of intent to submit
adverse comments on this SNUR.
Therefore, as required by
§ 721.160(c)(3)(ii), EPA withdrew the
direct final SNURs in the Federal
Register of January 19, 2017 (82 FR
6277) (FRL–9958–20), and is now
issuing this proposed rule on the
chemical substance. The records for the
direct final SNUR on the chemical
substance were established as docket
EPA–HQ–OPPT–2016–0207. Those
records include information considered
by the Agency in developing the direct
final rule. While notices of intent to
submit adverse comments were received
during the direct final rule phase, only
one substantive comment was
submitted. The commenter noted a
discrepancy between requirements in
the consent order and SNUR. While the
consent order allows limited surface
water releases from the manufacturing
process, the direct final SNUR
designated as a significant new use any
purposeful or predictable releases to
surface waters. To make the SNUR
consistent with consent order
requirements, in this proposed SNUR
EPA has designated as a significant new
use any predictable or purposeful
releases to water from manufacturing,
processing, or use other than the water
releases described in the PMN for the
manufacturing process of P–11–482.
EPA awaits further comment during the
open comment period for this proposed
rule.
furthermore prohibits such
manufacturing or processing from
commencing until EPA has conducted a
review of the notice, made an
appropriate determination on the notice,
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.
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) 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 (15
U.S.C. 2604(a)(1)(B)(i)). TSCA
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,
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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
final rule. Provisions relating to user
fees appear at 40 CFR part 700.
According 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). In
particular, these requirements include
the information submission
requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by
TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR
part 720. Once EPA receives a SNUN,
EPA must either 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
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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 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 Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for one
chemical substance in 40 CFR part 721,
subpart E. In this unit, EPA provides the
following information for the chemical
substance:
• PMN number.
• Chemical name (generic name, if
the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS)
Registry number (assigned for nonconfidential chemical identities).
• Public comments and EPA’s
response to comments on the direct
final SNURs.
• Basis for the TSCA non-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 VII. for more information).
• CFR citation assigned in the
regulatory text section of this proposed
rule.
The regulatory text section of this
proposed 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 proposed rule, may be
claimed as CBI.
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PMN Number P–11–482
Chemical name: Bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic use of the PMN substance
will be as a specialty additive. Based on
test data on analogous respirable, poorly
soluble particulates and nanocarbon
materials, EPA identified concerns for
pulmonary toxicity and oncogenicity.
Based on test data for other nanocarbon
materials EPA identified concerns for
environmental toxicity. The Order was
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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 these risks, the consent order
requires:
1. Use of personal protective
equipment involving impervious gloves
and protective clothing (where there is
a potential for dermal exposures) and a
National Institute for Occupational
Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face
respirator equipped with N–100, P–100,
or R–100 cartridges, or power air
purifying particulate respirator with an
Assigned Protection Factor (APF) of at
least 50 (where there is a potential for
inhalation exposures).
2. Submission of a dustiness test
within six months of notice of
commencement of manufacture (NOC).
3. Submission of certain physical
chemical properties data within the
time limits specified in the consent
order.
4. Processing and use of the PMN
substance only for the use specified in
the consent order, including no
application method that generates a
vapor, mist or aerosol unless the
application method occurs in an
enclosed process.
5. No predictable or purposeful
releases to water from manufacturing,
processing, or use other than the water
releases described in the PMN for the
manufacturing process of P–11–482 and
disposal of the PMN substance only by
landfill or incineration.
The SNUR would designate as a
‘‘significant new use’’ the absence of
these protective measures.
Recommended testing: EPA has
determined that the development of
data on certain physical-chemical
properties, as well as certain human
health and environmental toxicity
testing would help characterize possible
effects of the substance. The submitter
has agreed to provide a dustiness test
(European Standard EU 15051) by six
months from commencement of
manufacture. In addition, the submitter
has agreed to provide certain physical
chemical property testing as required in
the consent order after the
commencement of manufacture.
Although the order does not require a
90-day inhalation toxicity test (OPPTS
Test Guideline 870.3465 or Organisation
for Economic Co-operation and
Development (OECD) Test Guideline
413) in rats with a post-exposure
observation period of up to 9 months
(including BALF analysis, a
determination of cardiovascular toxicity
(clinically-based blood/plasma protein
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analyses), and histopathology of the
heart), a two-year inhalation bioassay
(OPPTS Test Guideline 870.4200), a
daphnid chronic toxicity test (OPPTS
Test Guideline 850.1300), a fish early
life stage toxicity test (OPPTS Test
Guideline 850.1400), or an algal toxicity
test (OCSPP Test Guideline 850.4500),
the Order’s restrictions on manufacture,
processing, distribution in commerce,
and disposal will remain in effect until
the Order is modified or revoked by
EPA based on submission of this or
other relevant information.
CFR citation: 40 CFR 721.10927.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMN submitted
for the chemical substance that is
subject to this SNUR, EPA determined
that one or more of the criteria of
concern established at § 721.170 were
met. For additional discussion on this
chemical substance, see Units II. and IV.
of this proposed rule.
B. Objectives
EPA is proposing this SNUR for
specific chemical substance which have
undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this proposed rule:
• EPA would receive notice of any
person’s intent to manufacture or
process the listed chemical substance
for the described significant new use
before that activity begins.
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing the
listed chemical substance for the
described significant new use.
• EPA would be able to either
determine that the prospective
manufacture or processing is not likely
to present an unreasonable risk, or to
take necessary regulatory action
associated with any other
determination, before the described
significant new use of the chemical
substance occurs.
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 https://www.epa.gov/tscainventory.
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VI. Applicability of the Proposed Rule
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 substance
subject to this proposed 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 the chemical substance
identified in this proposed rule is 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.
The identity of the chemical substance
subject to this proposed rule has been
claimed as confidential and EPA has
received no post-PMN bona fide
submissions (per §§ 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 proposed rule are
ongoing.
Therefore, EPA designates February
28, 2017 (the date of public release/web
posting of this proposed rule), as the
cutoff date for determining whether the
new use is ongoing. This designation
varies slightly from EPA’s past practice
of designating the date of Federal
Register publication as the date for
making this determination. The
objective of EPA’s approach has been to
ensure that a person could not defeat a
SNUR by initiating a significant new use
before the effective date of the proposed
rule. In developing this proposed rule,
EPA has recognized that, given EPA’s
practice of now posting rules on its Web
site a week or more in advance of
Federal Register publication, this
objective could be thwarted even before
that publication. Thus, EPA has slightly
modified its approach in this
rulemaking and plans to follow this
modified approach in future significant
new use rulemakings.
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
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review period, including any
extensions, expires. If such a person met
the conditions of advance compliance
under § 721.45(h), the person would be
considered exempt from the
requirements of the SNUR. Consult the
Federal Register document of April 24,
1990 (55 FR 17376) for a more detailed
discussion of the cutoff date for ongoing
uses.
VII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require developing any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception:
Development of test data is required
where the chemical substance subject to
the SNUR is also subject to a rule, order
or consent agreement under TSCA
section 4 (see TSCA section 5(b)(1)).
In the absence of a TSCA section 4
test rule covering the chemical
substance, persons are required only to
submit information in their possession
or control and to describe any other
information known to or reasonably
ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs
and SNUNs, the Agency has the
authority to require appropriate testing.
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 https://
www.epa.gov/ocspp and select ‘‘Test
Guidelines for Pesticides and Toxic
Substances.’’
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 and define the terms of any
potentially necessary controls if the
submitter provides detailed information
on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
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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 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 721.25. E–PMN software is
available electronically at https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca/
how-submit-e-pmn.
IX. Scientific Standards, Evidence, and
Available Information
EPA has used scientific information,
technical procedures, measures,
methods, protocols, methodologies, and
models consistent with the risk
assessment documents included in the
public docket. These information
sources supply information relevant to
whether a particular use would be a
significant new use, based on relevant
factors including those listed under
TSCA section 5(a)(2).
The clarity and completeness of the
data, assumptions, methods, quality
assurance, and analyses employed in
EPA’s decision are documented, as
applicable and to the extent necessary
for purposes of this proposed significant
new use rule, in Unit II and in the
documents noted above. EPA
recognizes, based on the available
information, that there is variability and
uncertainty in whether any particular
significant new use would actually
present an unreasonable risk. For
precisely this reason, it is appropriate to
secure a future notice and review
process for these uses, at such time as
they are known more definitely. The
extent to which the various information,
procedures, measures, methods,
protocols, methodologies or models
used in EPA’s decision have been
subject to independent verification or
peer review is adequate to justify their
use, collectively, in the record for a
significant new use rule.
X. 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, during the
development of the direct final rule.
EPA’s complete economic analysis is
available in the docket under docket ID
number EPA–HQ–OPPT–2016–0207.
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Federal Register / Vol. 82, No. 109 / Thursday, June 8, 2017 / Proposed Rules
XI. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish
SNUR for the chemical substance that
was the subject of PMN. 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).
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
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 proposed
rule have already been approved by
OMB pursuant to PRA under OMB
control number 2070–0012 (EPA ICR
No. 574). This proposed rule would 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:
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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.
A copy of that certification is
available in the docket for this proposed
rule.
This proposed rule is within the
scope of the February 18, 2012
certification. Based on the Economic
Analysis discussed in Unit IX. 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 would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would 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 proposed rule 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 would it
involve or impose any requirements that
affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination
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Frm 00044
Fmt 4702
Sfmt 4702
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
This proposed rule 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
proposed rule does not address
environmental health or safety risks
disproportionately affecting children.
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 proposed rule is
not expected to affect energy supply,
distribution, or use and because this
proposed rule is not a significant
regulatory action under Executive Order
12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this proposed rule
would not involve any technical
standards, NTTAA section 12(d) (15
U.S.C. 272 note), would not apply to
this proposed rule.
J. Executive Order 12898
This proposed rule 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: February 21, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR
chapter I be 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 § 721.10927 to subpart E to
read as follows:
■
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asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
§ 721.10927 Bimodal mixture consisting of
multi-walled carbon nanotubes and other
classes of carbon nanotubes (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as a bimodal mixture
consisting of multi-walled carbon
nanotubes and other classes of carbon
nanotubes (PMN P–11–482) 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 § 721.63
(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4),
(a)(6) (particulate), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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. A
National Institute for Occupational
Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face
respirator equipped with N–100, P–100,
or R–100 cartridges, or power air
purifying particulate respirator with an
Assigned Protection Factor (APF) of at
least 50 meets the requirements of
§ 721.63 (a)(4).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80 (k) and (q). A
significant new use is any use involving
an application method that generates a
vapor, mist or aerosol.
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (a)(2), (b)(1),
(b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as
specified in § 721.90 (b)(1) and (c)(1).
Any predictable or purposeful release of
a manufacturing stream associated with
any use of the substance from any site
is a significant new use other than the
water releases described in the
manufacturing process of PMN P–11–
482.
(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 § 721.125
(a) through (e), (i), (j), 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.
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17:20 Jun 07, 2017
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(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725 (b)(1) apply to paragraph
(a)(2)(ii) of this section.
[FR Doc. 2017–11695 Filed 6–7–17; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 483
[CMS–3342–P]
RIN 0938–AT18
Medicare and Medicaid Programs;
Revision of Requirements for LongTerm Care Facilities: Arbitration
Agreements
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
revise the requirements that Long-Term
Care (LTC) facilities must meet to
participate in the Medicare and
Medicaid programs. Specifically, it
would remove provisions prohibiting
binding pre-dispute arbitration and
strengthen requirements regarding the
transparency of arbitration agreements
in LTC facilities. This proposal would
support the resident’s right to make
informed choices about important
aspects of his or her health care. In
addition, this proposal is consistent
with our approach to eliminating
unnecessary burden on providers.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on August 7, 2017.
ADDRESSES: In commenting, please refer
to file code CMS–3342–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3342–P, P.O. Box 8010, Baltimore,
MD 21244–1850.
SUMMARY:
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26649
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3342–P, Mail
Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments ONLY to the
following addresses prior to the close of
the comment period:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: LTC
Regulations Team: Diane Corning,
Sheila Blackstock or Lisa Parker at (410)
786–6633.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
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Agencies
[Federal Register Volume 82, Number 109 (Thursday, June 8, 2017)]
[Proposed Rules]
[Pages 26644-26649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11695]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2016-0207; FRL-9959-37]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under the
Toxic Substances Control Act (TSCA) for one chemical substance that was
the subject of a premanufacture notice (PMN). The applicable review
period for the PMN submitted for this chemical substance ended prior to
June 22, 2016, the date on which President Obama signed into law the
Frank R. Lautenberg Chemical Safety for the 21st Century Act (which
amends TSCA). This action would require persons who intend to
manufacture (defined by statute to include import) or process the
chemical substance for an activity that is designated as a significant
new use by this proposed rule to notify EPA at least 90 days before
commencing that activity. The required notification initiates EPA's
evaluation of the intended use within the applicable review period.
Manufacture and processing for the significant new use is unable to
commence until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and take such actions as are
required with that determination.
DATES: Comments must be received on or before July 10, 2017.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0207, 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:
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 substance 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
[[Page 26645]]
determine whether this document applies to them. Potentially affected
entities may include:
Manufacturers (including importers) or processors of the subject
chemical substance (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 to 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 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 this SNUR under TSCA section 5(a)(2) for the
chemical substance that was the subject of PMN P-11-482. This SNUR
would require persons who intend to manufacture or process this
chemical substance for an activity that is designated as a significant
new use to notify EPA at least 90 days before commencing that activity.
In accordance with the procedures at Sec. 721.160(c)(3)(i), in the
Federal Register publication of November 17, 2016 (81 FR 81250) (FRL-
9953-41) EPA issued a direct final SNUR on this chemical substance,
which is the subject of a PMN. EPA received a notice of intent to
submit adverse comments on this SNUR. Therefore, as required by Sec.
721.160(c)(3)(ii), EPA withdrew the direct final SNURs in the Federal
Register of January 19, 2017 (82 FR 6277) (FRL-9958-20), and is now
issuing this proposed rule on the chemical substance. The records for
the direct final SNUR on the chemical substance were established as
docket EPA-HQ-OPPT-2016-0207. Those records include information
considered by the Agency in developing the direct final rule. While
notices of intent to submit adverse comments were received during the
direct final rule phase, only one substantive comment was submitted.
The commenter noted a discrepancy between requirements in the consent
order and SNUR. While the consent order allows limited surface water
releases from the manufacturing process, the direct final SNUR
designated as a significant new use any purposeful or predictable
releases to surface waters. To make the SNUR consistent with consent
order requirements, in this proposed SNUR EPA has designated as a
significant new use any predictable or purposeful releases to water
from manufacturing, processing, or use other than the water releases
described in the PMN for the manufacturing process of P-11-482. EPA
awaits further comment during the open comment period for this proposed
rule.
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)
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 (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the notice, made an appropriate determination
on the notice, 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 final
rule. Provisions relating to user fees appear at 40 CFR part 700.
According 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). In particular, these
requirements include the information submission requirements of TSCA
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN, EPA must either 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,
[[Page 26646]]
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
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 Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for one chemical substance in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for the chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (assigned
for non-confidential chemical identities).
Public comments and EPA's response to comments on the
direct final SNURs.
Basis for the TSCA non-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 VII. for more
information).
CFR citation assigned in the regulatory text section of
this proposed rule.
The regulatory text section of this proposed 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 proposed rule, may be claimed as CBI.
PMN Number P-11-482
Chemical name: Bimodal mixture consisting of multi-walled carbon
nanotubes and other classes of carbon nanotubes (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic use of the PMN
substance will be as a specialty additive. Based on test data on
analogous respirable, poorly soluble particulates and nanocarbon
materials, EPA identified concerns for pulmonary toxicity and
oncogenicity. Based on test data for other nanocarbon materials EPA
identified concerns for environmental toxicity. 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 these risks,
the consent order requires:
1. Use of personal protective equipment involving impervious gloves
and protective clothing (where there is a potential for dermal
exposures) and a National Institute for Occupational Safety and Health
(NIOSH)-certified air purifying, tight-fitting full-face respirator
equipped with N-100, P-100, or R-100 cartridges, or power air purifying
particulate respirator with an Assigned Protection Factor (APF) of at
least 50 (where there is a potential for inhalation exposures).
2. Submission of a dustiness test within six months of notice of
commencement of manufacture (NOC).
3. Submission of certain physical chemical properties data within
the time limits specified in the consent order.
4. Processing and use of the PMN substance only for the use
specified in the consent order, including no application method that
generates a vapor, mist or aerosol unless the application method occurs
in an enclosed process.
5. No predictable or purposeful releases to water from
manufacturing, processing, or use other than the water releases
described in the PMN for the manufacturing process of P-11-482 and
disposal of the PMN substance only by landfill or incineration.
The SNUR would designate as a ``significant new use'' the absence
of these protective measures.
Recommended testing: EPA has determined that the development of
data on certain physical-chemical properties, as well as certain human
health and environmental toxicity testing would help characterize
possible effects of the substance. The submitter has agreed to provide
a dustiness test (European Standard EU 15051) by six months from
commencement of manufacture. In addition, the submitter has agreed to
provide certain physical chemical property testing as required in the
consent order after the commencement of manufacture.
Although the order does not require a 90-day inhalation toxicity
test (OPPTS Test Guideline 870.3465 or Organisation for Economic Co-
operation and Development (OECD) Test Guideline 413) in rats with a
post-exposure observation period of up to 9 months (including BALF
analysis, a determination of cardiovascular toxicity (clinically-based
blood/plasma protein analyses), and histopathology of the heart), a
two-year inhalation bioassay (OPPTS Test Guideline 870.4200), a daphnid
chronic toxicity test (OPPTS Test Guideline 850.1300), a fish early
life stage toxicity test (OPPTS Test Guideline 850.1400), or an algal
toxicity test (OCSPP Test Guideline 850.4500), the Order's restrictions
on manufacture, processing, distribution in commerce, and disposal will
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.10927.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMN submitted for the chemical substance that
is subject to this SNUR, EPA determined that one or more of the
criteria of concern established at Sec. 721.170 were met. For
additional discussion on this chemical substance, see Units II. and IV.
of this proposed rule.
B. Objectives
EPA is proposing this SNUR for specific chemical substance which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this proposed rule:
EPA would receive notice of any person's intent to
manufacture or process the listed chemical substance for the described
significant new use before that activity begins.
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing the listed chemical substance for the described significant
new use.
EPA would be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
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
https://www.epa.gov/tsca-inventory.
[[Page 26647]]
VI. Applicability of the Proposed Rule 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 substance subject to this proposed 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 the chemical substance identified in this proposed rule is
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. The identity of the chemical substance
subject to this proposed rule has 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 proposed rule are ongoing.
Therefore, EPA designates February 28, 2017 (the date of public
release/web posting of this proposed rule), as the cutoff date for
determining whether the new use is ongoing. This designation varies
slightly from EPA's past practice of designating the date of Federal
Register publication as the date for making this determination. The
objective of EPA's approach has been to ensure that a person could not
defeat a SNUR by initiating a significant new use before the effective
date of the proposed rule. In developing this proposed rule, EPA has
recognized that, given EPA's practice of now posting rules on its Web
site a week or more in advance of Federal Register publication, this
objective could be thwarted even before that publication. Thus, EPA has
slightly modified its approach in this rulemaking and plans to follow
this modified approach in future significant new use rulemakings.
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
(55 FR 17376) for a more detailed discussion of the cutoff date for
ongoing uses.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. 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 https://www.epa.gov/ocspp and
select ``Test Guidelines for Pesticides and Toxic Substances.''
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 and define the terms of any potentially necessary
controls if the submitter provides detailed information on the
following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 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 721.25. E-PMN software is available
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.
IX. Scientific Standards, Evidence, and Available Information
EPA has used scientific information, technical procedures,
measures, methods, protocols, methodologies, and models consistent with
the risk assessment documents included in the public docket. These
information sources supply information relevant to whether a particular
use would be a significant new use, based on relevant factors including
those listed under TSCA section 5(a)(2).
The clarity and completeness of the data, assumptions, methods,
quality assurance, and analyses employed in EPA's decision are
documented, as applicable and to the extent necessary for purposes of
this proposed significant new use rule, in Unit II and in the documents
noted above. EPA recognizes, based on the available information, that
there is variability and uncertainty in whether any particular
significant new use would actually present an unreasonable risk. For
precisely this reason, it is appropriate to secure a future notice and
review process for these uses, at such time as they are known more
definitely. The extent to which the various information, procedures,
measures, methods, protocols, methodologies or models used in EPA's
decision have been subject to independent verification or peer review
is adequate to justify their use, collectively, in the record for a
significant new use rule.
X. 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, during the development of the
direct final rule. EPA's complete economic analysis is available in the
docket under docket ID number EPA-HQ-OPPT-2016-0207.
[[Page 26648]]
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNUR for the chemical substance
that was the subject of PMN. 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 proposed
rule have already been approved by OMB pursuant to PRA under OMB
control number 2070-0012 (EPA ICR No. 574). This proposed rule would
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.
A copy of that certification is available in the docket for this
proposed rule.
This proposed rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit IX. 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 would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would 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 proposed rule 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 would 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 proposed rule 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 proposed rule does not address environmental
health or safety risks disproportionately affecting children.
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 proposed rule is not expected to affect energy supply,
distribution, or use and because this proposed rule is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would
not apply to this proposed rule.
J. Executive Order 12898
This proposed rule 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: February 21, 2017.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. 721.10927 to subpart E to read as follows:
[[Page 26649]]
Sec. 721.10927 Bimodal mixture consisting of multi-walled carbon
nanotubes and other classes of carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
bimodal mixture consisting of multi-walled carbon nanotubes and other
classes of carbon nanotubes (PMN P-11-482) 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)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(6)
(particulate), 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. A National
Institute for Occupational Safety and Health (NIOSH)-certified air
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 cartridges, or power air purifying particulate respirator
with an Assigned Protection Factor (APF) of at least 50 meets the
requirements of Sec. 721.63 (a)(4).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q). A significant new use is any
use involving an application method that generates a vapor, mist or
aerosol.
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
(iv) Release to water. Requirements as specified in Sec. 721.90
(b)(1) and (c)(1). Any predictable or purposeful release of a
manufacturing stream associated with any use of the substance from any
site is a significant new use other than the water releases described
in the manufacturing process of PMN P-11-482.
(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) through (e), (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.
(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.
[FR Doc. 2017-11695 Filed 6-7-17; 8:45 am]
BILLING CODE 6560-50-P