Significant New Use Rule on Certain Chemical Substances, 57846-57851 [2016-20310]
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[FR Doc. 2016–20029 Filed 8–23–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2016–0491; FRL–9951–06]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for two
chemical substances which were the
subject of premanufacture notices
(PMNs). This action would require
persons who intend to manufacture
(defined by statute to include import) or
process any of the chemical substances
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 taken such actions as are
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SUMMARY:
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required in association with that
determination.
DATES: Comments must be received on
or before September 23, 2016.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0491, 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 substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
Manufacturers (including importers)
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
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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 this proposed rule
on or after September 23, 2016 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.
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 these SNURs under
TSCA section 5(a)(2) for two chemical
substances which were the subject of
PMNs P–14–321 and P–14–323. These
SNURs would require persons who
intend to manufacture or process any of
these chemical substances for an
activity that is designated as a
significant new use to notify EPA at
least 90 days before commencing that
activity.
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III. Significant New Use Determination
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.
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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.
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PMN Number P–14–321 and P–14–323
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 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.
Chemical name:
Hydrochlorofluoropropane and
Hydrochlorofluoropropene (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: August 12, 2016.
Basis for TSCA section 5(e) consent
order: The PMN states that the generic
(non-confidential) use of the substances
will be as site-limited, isolated and
recycled intermediates. Based on test
data on the PMN substances, EPA
identified concerns for acute toxicity
including lethality to animals. The
Order was issued under TSCA section
5(a)(3)(B)(ii)(I) based on a finding that
the substance may present an
unreasonable risk of injury to human
health. To protect against these risks,
the consent order requires:
1. Submission of certain toxicity
testing on the PMN substances prior to
exceeding the time trigger specified in
the consent order of the PMN
substances.
2. Use of impervious gloves and
protective clothing where dermal
exposure is reasonably likely for
workers.
3. Use of respirators with an APF of
1000, in conjunction with a minimum
set of engineering controls to prevent
inhalation exposure for workers, or, as
an alternative to using respirators,
maintain workplace airborne
concentrations of the PMN substances at
or below a specified New Chemical
Exposure Limit (NCEL) of 130 parts per
million (ppm) for P–14–321 and 33
parts per billion (ppb) for P–14–323 as
an 8-hour time-weighted average, where
inhalation exposure is reasonably likely
for workers.
4. Use of engineering controls to limit
worker exposure and air release of the
PMN substances to the environment.
5. Label containers of the PMN
substances and provide Safety Data
Sheets and worker training.
6. Manufacture, process and use the
PMN substances only in an enclosed
process.
7. Use of the PMN substances only as
chemical intermediates.
8. No predictable or purposeful
release of the PMN substances from
manufacturing, processing or use into
the waters of the United States that
result in surface water concentrations
exceeding 8 ppb.
9. Prohibition on the distribution of
the PMN substances.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a subacute
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for two
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 (assigned for nonconfidential chemical identities).
• 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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inhalation toxicity: 28-day study (OECD
Test Guideline 412) in three species:
Mouse, rat, and rabbit (6 studies total)
and a combined repeated dose toxicity
study with the reproduction/
developmental toxicity screening test
(OECD Test Guideline 422) would help
characterize the human health effects of
the PMN substances. The submitter has
agreed to complete this testing by the
production limits identified in the
consent order.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA concluded
that 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 § 721.160 (see
Unit VI.).
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B. Objectives
EPA is proposing 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 proposed rule:
• EPA would 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 would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing a
listed chemical substance for the
described significant new use.
• EPA would be 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
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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.
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 substances
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 chemical substances identified
in this proposed 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. The
identities of the two chemical
substances subject to this proposed rule
have 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 August 15,
2016 (the date of public release/web
posting of this proposal) 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 final rule. In
developing this proposal, EPA has
recognized that, given EPA’s practice of
now posting proposed 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 August 15, 2016
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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 all TSCA
prerequisites for the commencement of
manufacture or processing have been
satisfied. 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. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing new
information (e.g., generating test data)
before submission of a SNUN. There is
an exception:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule, order, or consent agreement
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 test rule, order, or
consent agreement under TSCA section
4 covering the chemical substance,
persons are required only to submit
information in their possession or
control and to describe any other
information known to or reasonably
ascertainable by them (see 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 that does not itself
include information sufficient to permit
a reasoned evaluation may increase the
likelihood that EPA will either respond
with a determination that the
information available to the Agency is
insufficient to permit a reasoned
evaluation of the health and
environmental effects of the significant
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new use or, alternatively, that in the
absence of sufficient information, the
manufacture, processing, distribution in
commerce, use, or disposal of the
chemical substance may present an
unreasonable risk of injury.
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:
• 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.
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VIII. SNUN Submissions
EPA recommends that submitters
consult with the Agency prior to
submitting a SNUN to discuss what
information may be useful in evaluating
a significant new use. Discussions with
the Agency prior to submission can
afford ample time to conduct any tests
that might be helpful in evaluating risks
posed by the substance. 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-newchemicals-under-toxic-substancescontrol-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.
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
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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–2016–0491.
XI. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would establish
SNURs for two chemical substances that
were the subject of PMNs. The Office of
Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et
seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
The information collection
requirements related to this 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
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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.).
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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.
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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
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19:02 Aug 23, 2016
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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: August 15, 2016.
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—SIGNIFICANT NEW USES
OF CHEMICAL SUBSTANCES
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10926 to subpart E to
read as follows:
■
§ 721.10926 Hydrochlorofluoropropane
and Hydrochlorofluoropropene (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as
hydrochlorofluoropropane and
hydrochlorofluoropropene (generic)
(PMNs P–14–321 and P–14–323) 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) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (a)(2)(i), (a)(3), (a)(4),
(a)(6)(v), (a)(6)(vi), and (c). When
determining which persons are
reasonably likely to be exposed as
required for § 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 1000 meet the
requirements of § 721.63(a)(4):
(A) Any NIOSH-certified powered air
purifying full facepiece respirator
equipped with appropriate gas/vapor
(acid gas, organic vapor, or substance
specific) cartridges.
(B) Any NIOSH-certified powered airpurifying respirator equipped with a
hood or helmet and appropriate gas/
vapor (acid gas, organic vapor, or
substance specific) cartridges with
evidence demonstrating protection level
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Fmt 4702
Sfmt 4702
of 1,000 or greater. (Note: OSHA has
assigned APFs of 1000 for certain types
of hoods and helmets with powered air
purifying respirators (PAPRs) or
supplied air respirators (SARs) where
the manufacturer can demonstrate
adequate air flows to maintain positive
pressure inside the hood or helmet in
normal working conditions. However,
the employer must have evidence
provided by the respirator manufacturer
that the testing of these respirators
demonstrates performance at a level of
protection of 1,000 or greater to receive
an APF of 1,000. This level of
performance can best be demonstrated
by performing a Workplace Protection
Factor (WPF) or Simulated Workplace
Protection Factor (SWPF) study or
equivalent testing. Without testing data
that demonstrates a level of protection
of 1,000 or greater, all PAPRs and SARs
with helmets/hoods are to be treated as
loose-fitting facepiece respirators, and
receive an APF of 25.)
(C) Any NIOSH-certified continuous
flow supplied-air respirator equipped
with a full facepiece.
(D) Any NIOSH-certified continuous
flow supplied-air respirator equipped
with a hood or helmet with evidence
demonstrating protection level of 1,000
or greater. (See Note under (II), above)
(E) Any NIOSH-certified pressuredemand or other positive pressure mode
supplied-air respirator equipped with a
full facepiece.
(1) As an alternative to the respiratory
requirements listed here, a manufacturer
or processor may choose to follow the
New Chemical Exposure Limit (NCEL)
provisions listed in the TSCA section
5(e) consent order for this substance.
The NCEL is 130 parts per million for
P–14–321 and 33 parts per billion for P–
14–323 as an 8-hour time weighted
average (TWA) verified by actual
monitoring data.
(ii) Hazard communication program.
Requirements as specified in
§ 721.72(a), (b), (c), (d), (f), (g)(1)(i),
(g)(1)(fatal if inhaled), (g)(2)(ii),
(g)(2)(iv), (g)(2)(v), and (g)(2)(do not
release to water).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(a) and (g). It is a
significant new use to manufacture,
process, or use the PMN substances
without the engineering controls
described in the consent order to
prevent worker and environmental
exposures. It is a significant new use to
manufacture the PMN substances for
more than one year.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=8).
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Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Proposed Rules
(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), (b), (c), (d), (e), (f), (g), (h), (i), and
(k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2016–20310 Filed 8–23–16; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 64
[CG Docket Nos. 10–51 and 03–123; DA 16–
893]
Structure and Practices of the Video
Relay Service Program
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
In this document, the
Consumer and Governmental Affairs
Bureau (CGB or Bureau) of the Federal
Communications Commission (FCC or
Commission), pursuant to a delegation
of authority, proposes to incorporate
into the Commission’s rules the Video
Relay Service (VRS) interoperability and
portability standards developed by the
VRS Task Group of the Session
Initiation Protocol (SIP) Forum and a
successor group, the Relay User
Equipment (RUE) Forum.
DATES: Comments are due on or before
September 14, 2016.
ADDRESSES: You may submit comments,
identified by CG Docket Nos. 10–51 and
03–123, by any of the following
methods:
• Electronic Filers: Comments may be
filed electronically using the Internet by
accessing the Commission’s Electronic
Comment Filing System (ECFS): https://
apps.fcc.gov/ecfs//. Filers should follow
the instructions provided on the
Commission’s Web site for submitting
comments. For ECFS filers, in
completing the transmittal screens,
filers should include their full name,
U.S. Postal Service mailing address, and
CG Docket Nos. 10–51 and 03–123.
• Paper Filers: Parties who choose to
file by paper must file an original and
one copy of each filing. If more than one
docket or rulemaking number appears in
the caption of this proceeding, filers
must submit two additional copies for
mstockstill on DSK3G9T082PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
19:02 Aug 23, 2016
Jkt 238001
each additional docket or rulemaking
number. Filings can be sent by hand or
messenger delivery, by commercial
overnight courier, or by first-class or
overnight U.S. Postal Service mail. All
filings must be addressed to the
Commission’s Secretary, Office of the
Secretary, Federal Communications
Commission.
• All hand-delivered or messengerdelivered paper filings for the
Commission’s Secretary must be
delivered to FCC Headquarters at 445
12th St. SW., Room TW–A325,
Washington, DC 20554. The filing hours
are 8:00 a.m. to 7:00 p.m. All hand
deliveries must be held together with
rubber bands or fasteners. Any
envelopes and boxes must be disposed
of before entering the building.
• Commercial overnight mail (other
than U.S. Postal Service Express Mail
and Priority Mail) must be sent to 9300
East Hampton Drive, Capitol Heights,
MD 20743.
U.S. Postal Service first-class, Express,
and Priority mail must be addressed to
445 12th Street SW., Washington, DC
20554.
FOR FURTHER INFORMATION CONTACT: Eliot
Greenwald, Consumer and
Governmental Affairs Bureau, at phone:
(202) 418–2235 or email:
Eliot.Greenwald@fcc.gov, or Robert
Aldrich, Consumer and Governmental
Affairs Bureau, at phone (202) 418–0996
or email: Robert.Aldrich@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Further
Notice of Proposed Rulemaking (Further
Notice), document DA 16–893, adopted
on August 4, 2016, and released on
August 4, 2016. The full text of this
document is available for public
inspection and copying via ECFS, and
during regular business hours at the
FCC Reference Information Center,
Portals II, 445 12th Street SW., Room
CY–A257, Washington, DC 20554. This
document can also be downloaded in
Word or Portable Document Format
(PDF) at: https://www.fcc.gov/general/
disability-rights-office-headlines. The
proceeding initiated by the Further
Notice shall be treated as a ‘‘permit-butdisclose’’ proceeding in accordance
with the Commission’s ex parte rules.
47 CFR 1.1200 et seq. Persons making ex
parte presentations must file a copy of
any written presentation or a
memorandum summarizing any oral
presentation within two business days
after the presentation (unless a different
deadline applicable to the Sunshine
period applies). Persons making oral ex
parte presentations are reminded that
memoranda summarizing the
presentation must (1) list all persons
PO 00000
Frm 00043
Fmt 4702
Sfmt 4702
57851
attending or otherwise participating in
the meeting at which the ex parte
presentation was made, and (2)
summarize all data presented and
arguments made during the
presentation. If the presentation
consisted in whole or in part of the
presentation of data or arguments
already reflected in the presenter’s
written comments, memoranda or other
filings in the proceeding, the presenter
may provide citations to such data or
arguments in his or her prior comments,
memoranda, or other filings (specifying
the relevant page and/or paragraph
numbers where such data or arguments
can be found) in lieu of summarizing
them in the memorandum. Documents
shown or given to Commission staff
during ex parte meetings are deemed to
be written ex parte presentations and
must be filed consistent with 47 CFR
1.1206(b). In proceedings governed by
47 CFR 1.49(f) or for which the
Commission has made available a
method of electronic filing, written ex
parte presentations and memoranda
summarizing oral ex parte
presentations, and all attachments
thereto, must be filed through the
electronic comment filing system
available for that proceeding, and must
be filed in their native format (e.g., .doc,
.xml, .ppt, searchable .pdf). Participants
in this proceeding should familiarize
themselves with the Commission’s ex
parte rules.
To request materials in accessible
formats for people with disabilities
(Braille, large print, electronic files,
audio format), send an email to fcc504@
fcc.gov or call the Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (844) 432–2275
(videophone), or (202) 418–0432 (TTY).
Initial Paperwork Reduction Act of
1995 Analysis
The Further Notice does not contain
proposed information collection
requirements subject to the Paperwork
Reduction Act of 1995, Public Law 104–
13. In addition, therefore, it does not
contain any proposed information
collection burden for small business
concerns with fewer than 25 employees,
pursuant to the Small Business
Paperwork Relief Act of 2002, Public
Law 107–198, see 44 U.S.C. 3506(c)(4).
Synopsis
1. In 2013, the Commission amended
its rules to improve the effectiveness of
its interoperability and portability rules
for video relay service (VRS), in order to
improve functional equivalence and
VRS availability for consumers, ease of
compliance by providers, and overall
efficiency in the operation of the
E:\FR\FM\24AUP1.SGM
24AUP1
Agencies
[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Proposed Rules]
[Pages 57846-57851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20310]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2016-0491; FRL-9951-06]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for two chemical substances which
were the subject of premanufacture notices (PMNs). This action would
require persons who intend to manufacture (defined by statute to
include import) or process any of the chemical substances 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 taken such actions as are required in association with that
determination.
DATES: Comments must be received on or before September 23, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0491, 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 substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers (including importers) 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 this proposed rule on or after
September 23, 2016 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 these SNURs under TSCA section 5(a)(2) for two
chemical substances which were the subject of PMNs P-14-321 and P-14-
323. These SNURs would require persons who intend to manufacture or
process any of these chemical substances for an activity that is
designated as a significant new use to notify EPA at least 90 days
before commencing that activity.
[[Page 57847]]
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, 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 two 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 (assigned
for non-confidential chemical identities).
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-14-321 and P-14-323
Chemical name: Hydrochlorofluoropropane and
Hydrochlorofluoropropene (generic).
CAS number: Claimed confidential.
Effective date of TSCA section 5(e) consent order: August 12, 2016.
Basis for TSCA section 5(e) consent order: The PMN states that the
generic (non-confidential) use of the substances will be as site-
limited, isolated and recycled intermediates. Based on test data on the
PMN substances, EPA identified concerns for acute toxicity including
lethality to animals. The Order was issued under TSCA section
5(a)(3)(B)(ii)(I) based on a finding that the substance may present an
unreasonable risk of injury to human health. To protect against these
risks, the consent order requires:
1. Submission of certain toxicity testing on the PMN substances
prior to exceeding the time trigger specified in the consent order of
the PMN substances.
2. Use of impervious gloves and protective clothing where dermal
exposure is reasonably likely for workers.
3. Use of respirators with an APF of 1000, in conjunction with a
minimum set of engineering controls to prevent inhalation exposure for
workers, or, as an alternative to using respirators, maintain workplace
airborne concentrations of the PMN substances at or below a specified
New Chemical Exposure Limit (NCEL) of 130 parts per million (ppm) for
P-14-321 and 33 parts per billion (ppb) for P-14-323 as an 8-hour time-
weighted average, where inhalation exposure is reasonably likely for
workers.
4. Use of engineering controls to limit worker exposure and air
release of the PMN substances to the environment.
5. Label containers of the PMN substances and provide Safety Data
Sheets and worker training.
6. Manufacture, process and use the PMN substances only in an
enclosed process.
7. Use of the PMN substances only as chemical intermediates.
8. No predictable or purposeful release of the PMN substances from
manufacturing, processing or use into the waters of the United States
that result in surface water concentrations exceeding 8 ppb.
9. Prohibition on the distribution of the PMN substances.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of a
subacute
[[Page 57848]]
inhalation toxicity: 28-day study (OECD Test Guideline 412) in three
species: Mouse, rat, and rabbit (6 studies total) and a combined
repeated dose toxicity study with the reproduction/developmental
toxicity screening test (OECD Test Guideline 422) would help
characterize the human health effects of the PMN substances. The
submitter has agreed to complete this testing by the production limits
identified in the consent order.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that 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. [emsp14]721.160 (see Unit VI.).
B. Objectives
EPA is proposing 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 proposed rule:
EPA would 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 would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA would be 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.
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 substances 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 chemical substances identified in this proposed 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. The identities of the two chemical substances
subject to this proposed 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 proposed rule are ongoing.
Therefore, EPA designates August 15, 2016 (the date of public
release/web posting of this proposal) 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 final rule. In developing this proposal, EPA has recognized
that, given EPA's practice of now posting proposed 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 August
15, 2016 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 all TSCA prerequisites for the commencement of manufacture
or processing have been satisfied. 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. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing new
information (e.g., generating test data) before submission of a SNUN.
There is an exception:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule, order, or
consent agreement 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 test rule, order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known to or reasonably ascertainable by
them (see 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 that does not itself include information
sufficient to permit a reasoned evaluation may increase the likelihood
that EPA will either respond with a determination that the information
available to the Agency is insufficient to permit a reasoned evaluation
of the health and environmental effects of the significant
[[Page 57849]]
new use or, alternatively, that in the absence of sufficient
information, the manufacture, processing, distribution in commerce,
use, or disposal of the chemical substance may present an unreasonable
risk of injury.
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:
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.
VIII. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what information may be useful in
evaluating a significant new use. Discussions with the Agency prior to
submission can afford ample time to conduct any tests that might be
helpful in evaluating risks posed by the substance. 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.
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-2016-0491.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would establish SNURs for two chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993).
B. Paperwork Reduction Act (PRA)
According to PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this 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.).
[[Page 57850]]
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: August 15, 2016.
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--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
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. [emsp14]721.10926 to subpart E to read as follows:
Sec. [emsp14]721.10926 Hydrochlorofluoropropane and
Hydrochlorofluoropropene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
hydrochlorofluoropropane and hydrochlorofluoropropene (generic) (PMNs
P-14-321 and P-14-323) 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) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(6)(v), (a)(6)(vi), and
(c). When determining which persons are reasonably likely to be exposed
as required for Sec. [thinsp]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 1000 meet the requirements
of Sec. [thinsp]721.63(a)(4):
(A) Any NIOSH-certified powered air purifying full facepiece
respirator equipped with appropriate gas/vapor (acid gas, organic
vapor, or substance specific) cartridges.
(B) Any NIOSH-certified powered air-purifying respirator equipped
with a hood or helmet and appropriate gas/vapor (acid gas, organic
vapor, or substance specific) cartridges with evidence demonstrating
protection level of 1,000 or greater. (Note: OSHA has assigned APFs of
1000 for certain types of hoods and helmets with powered air purifying
respirators (PAPRs) or supplied air respirators (SARs) where the
manufacturer can demonstrate adequate air flows to maintain positive
pressure inside the hood or helmet in normal working conditions.
However, the employer must have evidence provided by the respirator
manufacturer that the testing of these respirators demonstrates
performance at a level of protection of 1,000 or greater to receive an
APF of 1,000. This level of performance can best be demonstrated by
performing a Workplace Protection Factor (WPF) or Simulated Workplace
Protection Factor (SWPF) study or equivalent testing. Without testing
data that demonstrates a level of protection of 1,000 or greater, all
PAPRs and SARs with helmets/hoods are to be treated as loose-fitting
facepiece respirators, and receive an APF of 25.)
(C) Any NIOSH-certified continuous flow supplied-air respirator
equipped with a full facepiece.
(D) Any NIOSH-certified continuous flow supplied-air respirator
equipped with a hood or helmet with evidence demonstrating protection
level of 1,000 or greater. (See Note under (II), above)
(E) Any NIOSH-certified pressure-demand or other positive pressure
mode supplied-air respirator equipped with a full facepiece.
(1) As an alternative to the respiratory requirements listed here,
a manufacturer or processor may choose to follow the New Chemical
Exposure Limit (NCEL) provisions listed in the TSCA section 5(e)
consent order for this substance. The NCEL is 130 parts per million for
P-14-321 and 33 parts per billion for P-14-323 as an 8-hour time
weighted average (TWA) verified by actual monitoring data.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(fatal if
inhaled), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), and (g)(2)(do not release
to water).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(a) and (g). It is a significant new use to
manufacture, process, or use the PMN substances without the engineering
controls described in the consent order to prevent worker and
environmental exposures. It is a significant new use to manufacture the
PMN substances for more than one year.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=8).
[[Page 57851]]
(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), (f), (g), (h), (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.
[FR Doc. 2016-20310 Filed 8-23-16; 8:45 am]
BILLING CODE 6560-50-P