Significant New Use Rule on Certain Chemical Substances, 75812-75817 [2015-30677]
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations
duration occasionally between January
4, 2016 and February 19, 2016 to replace
larger bridge components as long as 72hours notice is given to the USCG
District Eight Western Rivers Bridge
Branch.
The Clinton Railroad Drawbridge
currently operates in accordance with
33 CFR 117.5, which states the general
requirement that the drawbridge shall
open on signal.
There are no alternate routes for
vessels transiting this section of the
Upper Mississippi River. The bridge
cannot open in case of emergency.
The Clinton Railroad Drawbridge
provides a vertical clearance of 18.7 feet
above normal pool in the closed-tonavigation position. Navigation on the
waterway consists primarily of
commercial tows and recreational
watercraft and will not be significantly
impacted. This temporary deviation has
been coordinated with waterway users.
No objections were received.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: November 25, 2015.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2015–30636 Filed 12–3–15; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2014–0390; FRL–9939–20]
RIN 2070–AB27
Significant New Use Rule on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
EPA is finalizing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 29
chemical substances that were the
subject of premanufacture notices
(PMNs). This action requires persons
who intend to manufacture (including
import) or process any of the chemical
substances for an activity that is
designated as a significant new use by
this rule to notify EPA at least 90 days
before commencing that activity. The
required notification would provide
EPA with the opportunity to evaluate
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SUMMARY:
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the intended use and, if necessary, to
prohibit or limit the activity before it
occurs.
DATES: This final rule is effective
February 2, 2016.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0390, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Kenneth
Moss, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–9232; email address:
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: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. 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
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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.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs, under TSCA
section 5(a)(2), for 29 chemical
substances that were the subject of
PMNs. This final rule requires 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.
In the Federal Register of October 27,
2014 (79 FR 63821) (FRL–9914–56),
EPA issued a direct final SNUR for 30
chemical substances. EPA received
notice of intent to submit adverse
comments for the direct final SNUR. In
response to that notification a rule was
proposed for the chemical substances in
the Federal Register of June 10, 2015
(80 FR 32879) (FRL–9927–60). EPA is
not finalizing one of the proposed
SNURs, as described below.
For the substance submitted as PMN
P–14–72, EPA received a comment from
the PMN submitter requesting review of
a screening hydrolysis study on the
PMN substance (Organisation for
Economic Co-operation and
Development (OECD) Test Guideline
111). The commenter suggested that this
study would aid in understanding the
fate of the chemical substance and lead
to a decision by EPA to rescind the
significant new use designation of a 3
parts per billion (ppb) surface water
concentration limit contained in that
proposed SNUR. EPA completed its
review and has determined that while
the study satisfies the screening level
stage of the OECD 111 test protocol, it
is not the full OECD 111 study as it does
not measure the hydrolysis products of
the PMN chemical substance. The
purpose of OECD 111 is to determine (1)
the rate of hydrolysis of the test
substance as a function of pH and (2)
the identity or nature and rates of
formation and decline of hydrolysis
products to which organisms may be
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations
exposed. This test guideline is designed
as a tiered approach which is shown
and explained in the guideline. Each
tier is triggered by the results of the
previous tier.
As stated in the proposed rule, EPA
determined that the results of a ready
biodegradability test with productspecific chemical analytics to validate
the degradation products (including
intermediate products) and the rates of
degradation (including intermediate
degradation rates) and a hydrolysis as a
function of pH and temperature test
would help characterize the
environmental effects of the PMN
substance P–14–72. Without additional
data identifying the hydrolysis products
EPA continues to have concerns for
toxicity at surface water concentrations
as low as 3 ppb. As a result, EPA is
finalizing the SNUR as proposed and
has determined that additional
information is still necessary in order to
determine whether or to what extent
hydrolysis products may be of concern
to aquatic organisms, which was the
basis for the original direct final SNUR
of October 27, 2014. Tier 3 of OECD Test
Guideline 111, the identification of
hydrolysis products, could be
conducted to better understand those
products. The results of this full
hydrolysis study on PMN substance P–
14–72 would then inform the need for
further recommended testing, including
aquatic toxicity or ready
biodegradability testing.
EPA received comments from the
PMN submitter of the remaining 28
chemicals in the proposed rule. These
chemicals were submitted as three
consolidated PMNs: P–14–89 through
P–14–92, P–14–158, P–14–159, P–14–
161, P–14–162, P–14–163, P–14–173, P–
14–175 through P–14–188, and P–14–
190 through P–14–193. The commenter
stated that the Agency had changed its
regulatory decision on these PMN
substances in an arbitrary and
capricious manner, from a SNUR with
the significant new use defined as uses
other than as described in the PMNs to
one with the significant new use
defined as any release of the PMN
substances to surface waters resulting in
the quotient from the equation provided
in 40 CFR 721.90 exceeding a certain
surface water concentration listed in the
SNUR. Further, the commenter claimed
that a SNUR for water releases (or a
limit on water concentration) presents
an analytical and record-keeping burden
on customers for the intended PMN end
uses of mineral flotation products and
surfactants in asphalt emulsions that
will cause the customers to instead
select other less-environmentally
beneficial products. The PMN submitter
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cited its practice of environmentallybeneficial reuse and recycling in the
manufacture of these PMN substances
starting with byproducts and other
waste streams from industrial processes.
The commenter also noted that there is
no incentive to conduct any testing to
address the Agency’s aquatic toxicity
concerns, because the PMN substances
are expected to exhibit some aquatic
toxicity and such results may only
result in an adjustment of the water
concentration levels while the analytical
and record-keeping burden remains.
EPA examined the comments on these
28 chemicals and has decided to modify
the proposed SNURs. EPA has
determined that any manufacturing,
processing or use of the substances
excluding uses as described in the
PMNs may result in surface water
concentrations exceeding the listed
concentrations of concern, which may
result in significant adverse
environmental effects. Because (1) the
potential benefits from use of low-value
byproduct waste streams to produce the
PMN substances and (2) the Agency has
determined that the uses described in
the PMNs are not expected to result in
significant releases exceeding the listed
concentrations of concern, EPA is
finalizing the SNURs on these 28
chemicals to limit the significant new
use to use other than as described in the
PMNs where the use is as a surfactant
in asphalt emulsions (for P–14–89
through P–14–92); additives in mineral
flotation products and as chemical
intermediates (for P–14–158, P–14–159,
P–14–161, P–14–162, P–14–163); or
flotation additives in mineral processing
(for P–14–173, P–14–175 through P–14–
188, and P–14–190 through P–14–193).
In addition, this final rule retains the
significant new use of where the surface
water concentrations described under
the significant new uses in a new
paragraph (a)(3)(i) are exceeded, but
these water release concentrations only
apply for uses other than as described
in the PMNs and mentioned in the
previous sentence.
EPA also received comments on the
proposed SNUR for the chemical
substance that is the subject of PMN P–
13–793. EPA is deferring action on that
substance to a later date, and intends to
respond to those comments and issue a
final SNUR at that time.
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,
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including the four bulleted TSCA
section 5(a)(2) factors, listed in Unit IV.
of this rule. Once EPA determines that
a use of a chemical substance is a
significant new use, TSCA section
5(a)(1)(B) requires persons to submit a
significant new use notice (SNUN) to
EPA at least 90 days before they
manufacture or process the chemical
substance for that use. Persons who
must report are described in § 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the final 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 may take regulatory action under
TSCA section 5(e), 5(f), 6, or 7 to control
the activities for which it has received
the SNUN. If EPA does not take action,
EPA is required under TSCA section
5(g) to explain in the Federal Register
its reasons for not taking action.
III. Rationale and Objectives of the
Final Rule
A. Rationale
During review of the PMNs 29
chemical substances which were the
subject of PMNs P–14–72, P–14–89, P–
14–90, P–14–91, P–14–92, P–14–158, P–
14–159, P–14–161, P–14–162, P–14–
163, P–14–173, P–14–175, P–14–176, P–
14–177, P–14–178, P–14–179, P–14–
180, P–14–181, P–14–182, P–14–183, P–
14–184, P–14–185, P–14–186, P–14–
187, P–14–188, P–14–190, P–14–191, P–
14–192, and P–14–193, EPA determined
that one or more of the criteria of
concern established at § 721.170 were
met. For additional discussion of the
rationale for the SNUR on this chemical,
see Units II., IV., and V. of the proposed
rule.
B. Objectives
EPA is issuing final SNURs for 29
chemical substances described above to
achieve the following objectives with
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regard to the significant new uses
designated in this final rule:
• EPA will receive notice of any
person’s intent to manufacture or
process a listed chemical substance for
the described significant new use before
that activity begins.
• EPA will have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing a
listed chemical substance for the
described significant new use.
• EPA will be able to regulate
prospective manufacturers or processors
of a listed chemical substance before the
described significant new use of that
chemical substance occurs, provided
that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
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/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
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IV. 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 listed in this final rule, 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.
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V. Applicability of the Significant New
Use Designation
If uses begun after the proposed rule
was published were considered ongoing
rather than new, any person could
defeat the SNUR by initiating the
significant new use before the final rule
was issued. Therefore EPA has
designated the date of publication of the
proposed rule as the cutoff date for
determining whether the new use is
ongoing. Consult the Federal Register
Notice of April 24, 1990 (55 FR 17376,
FRL 3658–5) for a more detailed
discussion of the cutoff date for ongoing
uses.
Any person who began commercial
manufacture or processing of the
chemical substances identified in this
rule for any of the significant new uses
designated in the proposed SNUR after
the date of publication of the proposed
SNUR, must stop that activity before the
effective date of the final rule. Persons
who ceased those activities will have to
first comply with all applicable SNUR
notification requirements and wait until
the notice review period, including any
extensions, expires, before engaging in
any activities designated as significant
new uses. If a person were to meet the
conditions of advance compliance
under 40 CFR 721.45(h), the person
would be considered to have met the
requirements of the final SNUR for
those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require the development of any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data known to or
reasonably ascertainable by them (see
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Recommended testing that would
address the criteria of concern of
§ 721.170 can be found in Unit IV. of the
proposed rule. Descriptions of tests are
provided only for informational
purposes. EPA strongly encourages
persons, before performing any testing,
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to consult with the Agency pertaining to
protocol selection.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
VII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notice requirements and EPA
regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in
§ 720.50. SNUNs must be on EPA Form
No. 7710–25, generated using e-PMN
software, and submitted to the Agency
in accordance with the procedures set
forth in §§ 721.25 and 720.40. E–PMN
software is available electronically at
https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA evaluated the potential costs of
SNUN requirements for potential
manufacturers and processors of the
chemical substances in the rule. The
Agency’s complete Economic Analysis
is available in the docket under docket
ID number EPA–HQ–OPPT–2014–0390.
IX. Statutory and Executive Order
Reviews
A. Executive Order 12866
This final rule establishes SNURs for
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. EPA is amending the table in
40 CFR part 9 to list the OMB approval
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number for the information collection
requirements contained in this final
rule. This listing of the OMB control
numbers and their subsequent
codification in the CFR satisfies the
display requirements of PRA and OMB’s
implementing regulations at 5 CFR part
1320. This Information Collection
Request (ICR) was previously subject to
public notice and comment prior to
OMB approval, and given the technical
nature of the table, EPA finds that
further notice and comment to amend it
is unnecessary. As a result, EPA finds
that there is ‘‘good cause’’ under section
553(b)(3)(B) of the Administrative
Procedure Act (5 U.S.C. 553(b)(3)(B)) to
amend this table without further notice
and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (5 U.S.C.
601 et seq.), that promulgation of a
SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is available
in the docket for this final rule.
This final rule is within the scope of
the February 18, 2012 certification.
Based on the Economic Analysis
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discussed in Unit VIII. 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.
environmental health or safety risks
disproportionately affecting children.
D. Unfunded Mandates Reform Act
(UMRA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
final rule. As such, EPA has determined
that this action does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
I. National Technology Transfer and
Advancement Act (NTTAA)
E. Executive Order 13132
This action will not have a substantial
direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This action does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This final rule does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this final rule.
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
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H. Executive Order 13211
This action is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
In addition, since this action does not
involve any technical standards,
NTTAA section 12(d) (15 U.S.C. 272
note), does not apply to this action.
J. Executive Order 12898
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: November 24, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
■
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
2. In § 9.1, add entries for
‘‘721.10780,’’ ‘‘721.10781,’’
‘‘721.10782,’’ and ‘‘721.10783’’ in
numerical order under the undesignated
center heading ‘‘Significant New Uses of
Chemical Substances’’ to read as
follows:
■
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
OMB Control
No.
40 CFR Citation
*
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.10780
721.10781
721.10782
721.10783
*
*
.............................
.............................
.............................
.............................
*
*
*
*
*
*
*
*
*
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
PART 721—[AMENDED]
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add § 721.10780 to subpart E to
read as follows:
■
wgreen on DSK2VPTVN1PROD with RULES
§ 721.10780 Propaneperoxoic acid, 2,2dimethyl-, 1,1,3,3-tetramethylbutyl ester.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propaneperoxoic acid, 2,2-dimethyl-,
1,1,3,3-tetramethylbutyl ester (PMN P–
14–72; CAS No. 22288–41–1) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
VerDate Sep<11>2014
15:14 Dec 03, 2015
Jkt 238001
§ 721.125(a), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 5. Add § 721.10781 to subpart E to
read as follows:
§ 721.10781 Fatty acid amide
hydrochlorides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acid amide
hydrochlorides (PMNs P–14–89, P–14–
90, P–14–91 and P–14–92) are subject to
reporting under this section for the
significant new uses described in
paragraphs (a)(2) and (3) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. The significant
new use is any use other than as a
surfactant in asphalt emulsions where
the surface water concentrations
described under the significant new
uses in paragraph (a)(3)(i) of this section
are exceeded.
(ii) [Reserved].
(3) The significant new uses for any
use other than as a surfactant in asphalt
emulsions:
(i) Release to water. Requirements as
specified 721.90 (a)(4), (b)(4), and (c)(4)
(where N=110 for PMNs P–14–89 and
P–14–92; N=240 for PMN P–14–90;
N=53 for PMN P–14–91).
(ii) [Reserved].
(b) Specific Requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i), and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 6. Add § 721.10782 to subpart E to
read as follows:
§ 721.10782
Fatty acid amides (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amides (PMN
P–14–158, P–14–159, P–14–161, P–14–
162, and P–14–163) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
specified in § 721.80. The significant
new use is any use other than as
additives in mineral flotation products
and as chemical intermediates where
the surface water concentrations
described under the significant new
uses in paragraph (a)(3)(i) of this section
are exceeded.
(ii) [Reserved].
(3) The significant new uses for any
use other than as additives in mineral
flotation products and as chemical
intermediates:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=1 for PMNs P–14–158,
P–14–159, P–14–161, and P–14–163;
N=140 for PMN P–14–162).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i) and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 7. Add § 721.10783 to subpart E to
read as follows:
§ 721.10783
(generic).
Fatty acid amide acetates
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid amide acetates
(PMNs P–14–173, P–14–175, P–14–176,
P–14–177, P–14–178, P–14–179, P–14–
180, P–14–181, P–14–182, P–14–183, P–
14–184, P–14–185, P–14–186, P–14–
187, P–14–188, P–14–190, P–14–191, P–
14–192 and P–14–193) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. The significant
new use is any use other than as
flotation additives in mineral processing
where the surface water concentrations
described under the significant new
uses in paragraph (a)(3)(i) of this section
are exceeded.
(ii) [Reserved].
(3) The significant new uses for any
use other than as flotation additives in
mineral processing:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N = concentration of
concern as follows):
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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations
PMN No.
P–14–173, P–14–175, P–
14–178, P–14–179, P–
14–181, P–14–183, P–
14–184, P–14–192, P–
14–193 ............................
P–14–176, P–14–180, P–
14–185, P–14–186, P–
14–187, P–14–190 ..........
P–14–177, P–14–188 .........
P–14–191 ...........................
P–14–182 ...........................
Concentration
of concern
1 ppb.
2
3
4
140
ppb.
ppb.
ppb.
ppb.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (i) and (k) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2015–30677 Filed 12–3–15; 8:45 am]
BILLING CODE 6560–50–P
email address: nizich.sharon@epa.gov.
For information about the applicability
of the national emission standards for
hazardous air pollutants, contact Mr.
Patrick Yellin, Monitoring, Assistance
and Media Programs Division (2227A),
Office of Enforcement and Compliance
Assurance, U.S. Environmental
Protection Agency, 1200 Pennsylvania
Avenue, Washington, DC 20460;
telephone number (202) 564–2970;
email address yellin.patrick@epa.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The EPA
published a document in the Federal
Register of October 26, 2015 (80 FR
65470). There were two errors included
in the final rule. First, the reference to
the IBR method (ASTM D6348–03) was
incorrect. The incorrect IBR method
reference included in the Federal
Register was paragraph (h)(75). The
correct reference is paragraph (h)(76).
Second, there was a typographical error
in 40 CFR 63.8605(c) referencing a
requirement of a non-existing section.
The incorrect non-existing reference is
40 CFR 63.8630(e). The correct reference
is 40 CFR 63.8630(c).
Medicaid Program; Mechanized Claims
Processing and Information Retrieval
Systems (90/10)
SUPPLEMENTARY INFORMATION:
Correction
ENVIRONMENTAL PROTECTION
AGENCY
In rule FR Doc. 2015–25724 published
on October 26, 2015 (80 FR 65470),
make the following corrections:
40 CFR Part 63
[EPA–HQ–OAR–2013–0290 and EPA–HQ–
OAR–2013–0291; FRL–9939–35–OAR]
RIN 2060–AP69
Environmental Protection
Agency (EPA).
ACTION: Final rule; correction.
AGENCY:
wgreen on DSK2VPTVN1PROD with RULES
15:14 Dec 03, 2015
[Corrected]
1. On page 65520:
a. In the second column, correct
amendatory instruction number 2.b. to
read ‘‘Revising paragraph (h)(76);’’.
■ b. In the second column, redesignate
paragraph (h)(75) as paragraph (h)(76).
■
§ 63.8605
Jkt 238001
[Corrected]
2. On page 65549, second column, in
paragraph (c), fifth line, remove
‘‘§ 63.8630(e).’’ and add ‘‘§ 63.8630(c).’’
in its place.
■
The Environmental Protection
Agency (EPA) published a final rule in
the Federal Register on October 26,
2015, titled NESHAP for Brick and
Structural Clay Products Manufacturing;
and NESHAP for Clay Ceramics
Manufacturing. These amendments
make two technical corrections to the
published regulation.
DATES: This action is effective December
28, 2015.
FOR FURTHER INFORMATION CONTACT: Ms.
Sharon Nizich, Sector Policies and
Programs Division (D243–04), Office of
Air Quality Planning and Standards,
U.S. Environmental Protection Agency,
Research Triangle Park, North Carolina
27711, telephone number: (919) 541–
2825; facsimile number: (919) 541–5450;
SUMMARY:
VerDate Sep<11>2014
§ 63.14
■
NESHAP for Brick and Structural Clay
Products Manufacturing; and NESHAP
for Clay Ceramics Manufacturing:
Correction
75817
Dated: November 18, 2015.
Janet G. McCabe,
Acting Assistant Administrator, Office of Air
and Radiation.
[FR Doc. 2015–30379 Filed 12–3–15; 8:45 am]
BILLING CODE 6560–50–P
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45 CFR Part 95
Centers for Medicare & Medicaid
Services
42 CFR Part 433
[CMS–2392–F]
RIN 0938–AS53
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule will extend
enhanced funding for Medicaid
eligibility systems as part of a state’s
mechanized claims processing system,
and will update conditions and
standards for such systems, including
adding to and updating current
Medicaid Management Information
Systems (MMIS) conditions and
standards. These changes will allow
states to improve customer service and
support the dynamic nature of Medicaid
eligibility, enrollment, and delivery
systems.
SUMMARY:
Effective Date: These regulations
are effective on January 1, 2016.
FOR FURTHER INFORMATION CONTACT:
Victoria Guarisco (410) 786–0265, for
issues related to administrative
questions.
Carrie Feher (410) 786–8905, for
issues related to the regulatory impact
analysis.
Christine Gerhardt (410) 786–0693 or
Martin Rice (410) 786–2417, for general
questions.
SUPPLEMENTARY INFORMATION:
DATES:
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs and Benefits
II. Background
A. Legislative History and Statutory
Authority
B. Program Affected
III. Provisions of the Proposed Rule and
Responses to Comments
A. Amendments to 42 CFR Part 433
B. Technical Changes to 42 CFR Part 433,
Subpart C-Mechanized Claims and
Processing Information Retrieval
Systems
C. Changes to 45 CFR Part 95—General
Administration—Grant Programs,
Subpart F
IV. Provisions of the Final Regulations
V. Collection of Information Requirements
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]]>Agencies
[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Rules and Regulations]
[Pages 75812-75817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30677]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0390; FRL-9939-20]
RIN 2070-AB27
Significant New Use Rule on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is finalizing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 29 chemical substances that
were the subject of premanufacture notices (PMNs). This action requires
persons who intend to manufacture (including import) or process any of
the chemical substances for an activity that is designated as a
significant new use by this rule to notify EPA at least 90 days before
commencing that activity. The required notification would provide EPA
with the opportunity to evaluate the intended use and, if necessary, to
prohibit or limit the activity before it occurs.
DATES: This final rule is effective February 2, 2016.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2014-0390, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: 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. 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 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. [emsp14]721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
II. Background
A. What action is the Agency taking?
EPA is finalizing SNURs, under TSCA section 5(a)(2), for 29
chemical substances that were the subject of PMNs. This final rule
requires 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.
In the Federal Register of October 27, 2014 (79 FR 63821) (FRL-
9914-56), EPA issued a direct final SNUR for 30 chemical substances.
EPA received notice of intent to submit adverse comments for the direct
final SNUR. In response to that notification a rule was proposed for
the chemical substances in the Federal Register of June 10, 2015 (80 FR
32879) (FRL-9927-60). EPA is not finalizing one of the proposed SNURs,
as described below.
For the substance submitted as PMN P-14-72, EPA received a comment
from the PMN submitter requesting review of a screening hydrolysis
study on the PMN substance (Organisation for Economic Co-operation and
Development (OECD) Test Guideline 111). The commenter suggested that
this study would aid in understanding the fate of the chemical
substance and lead to a decision by EPA to rescind the significant new
use designation of a 3 parts per billion (ppb) surface water
concentration limit contained in that proposed SNUR. EPA completed its
review and has determined that while the study satisfies the screening
level stage of the OECD 111 test protocol, it is not the full OECD 111
study as it does not measure the hydrolysis products of the PMN
chemical substance. The purpose of OECD 111 is to determine (1) the
rate of hydrolysis of the test substance as a function of pH and (2)
the identity or nature and rates of formation and decline of hydrolysis
products to which organisms may be
[[Page 75813]]
exposed. This test guideline is designed as a tiered approach which is
shown and explained in the guideline. Each tier is triggered by the
results of the previous tier.
As stated in the proposed rule, EPA determined that the results of
a ready biodegradability test with product-specific chemical analytics
to validate the degradation products (including intermediate products)
and the rates of degradation (including intermediate degradation rates)
and a hydrolysis as a function of pH and temperature test would help
characterize the environmental effects of the PMN substance P-14-72.
Without additional data identifying the hydrolysis products EPA
continues to have concerns for toxicity at surface water concentrations
as low as 3 ppb. As a result, EPA is finalizing the SNUR as proposed
and has determined that additional information is still necessary in
order to determine whether or to what extent hydrolysis products may be
of concern to aquatic organisms, which was the basis for the original
direct final SNUR of October 27, 2014. Tier 3 of OECD Test Guideline
111, the identification of hydrolysis products, could be conducted to
better understand those products. The results of this full hydrolysis
study on PMN substance P-14-72 would then inform the need for further
recommended testing, including aquatic toxicity or ready
biodegradability testing.
EPA received comments from the PMN submitter of the remaining 28
chemicals in the proposed rule. These chemicals were submitted as three
consolidated PMNs: P-14-89 through P-14-92, P-14-158, P-14-159, P-14-
161, P-14-162, P-14-163, P-14-173, P-14-175 through P-14-188, and P-14-
190 through P-14-193. The commenter stated that the Agency had changed
its regulatory decision on these PMN substances in an arbitrary and
capricious manner, from a SNUR with the significant new use defined as
uses other than as described in the PMNs to one with the significant
new use defined as any release of the PMN substances to surface waters
resulting in the quotient from the equation provided in 40 CFR 721.90
exceeding a certain surface water concentration listed in the SNUR.
Further, the commenter claimed that a SNUR for water releases (or a
limit on water concentration) presents an analytical and record-keeping
burden on customers for the intended PMN end uses of mineral flotation
products and surfactants in asphalt emulsions that will cause the
customers to instead select other less-environmentally beneficial
products. The PMN submitter cited its practice of environmentally-
beneficial reuse and recycling in the manufacture of these PMN
substances starting with byproducts and other waste streams from
industrial processes. The commenter also noted that there is no
incentive to conduct any testing to address the Agency's aquatic
toxicity concerns, because the PMN substances are expected to exhibit
some aquatic toxicity and such results may only result in an adjustment
of the water concentration levels while the analytical and record-
keeping burden remains.
EPA examined the comments on these 28 chemicals and has decided to
modify the proposed SNURs. EPA has determined that any manufacturing,
processing or use of the substances excluding uses as described in the
PMNs may result in surface water concentrations exceeding the listed
concentrations of concern, which may result in significant adverse
environmental effects. Because (1) the potential benefits from use of
low-value byproduct waste streams to produce the PMN substances and (2)
the Agency has determined that the uses described in the PMNs are not
expected to result in significant releases exceeding the listed
concentrations of concern, EPA is finalizing the SNURs on these 28
chemicals to limit the significant new use to use other than as
described in the PMNs where the use is as a surfactant in asphalt
emulsions (for P-14-89 through P-14-92); additives in mineral flotation
products and as chemical intermediates (for P-14-158, P-14-159, P-14-
161, P-14-162, P-14-163); or flotation additives in mineral processing
(for P-14-173, P-14-175 through P-14-188, and P-14-190 through P-14-
193). In addition, this final rule retains the significant new use of
where the surface water concentrations described under the significant
new uses in a new paragraph (a)(3)(i) are exceeded, but these water
release concentrations only apply for uses other than as described in
the PMNs and mentioned in the previous sentence.
EPA also received comments on the proposed SNUR for the chemical
substance that is the subject of PMN P-13-793. EPA is deferring action
on that substance to a later date, and intends to respond to those
comments and issue a final SNUR at that time.
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 IV. of this rule. Once EPA determines that a
use of a chemical substance is a significant new use, TSCA section
5(a)(1)(B) requires persons to submit a significant new use notice
(SNUN) to EPA at least 90 days before they manufacture or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the final 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. [emsp14]721.1(c), persons subject to these SNURs
must comply with the same SNUN requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In
particular, these requirements include the information submission
requirements of TSCA 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 may take
regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the
activities for which it has received the SNUN. If EPA does not take
action, EPA is required under TSCA section 5(g) to explain in the
Federal Register its reasons for not taking action.
III. Rationale and Objectives of the Final Rule
A. Rationale
During review of the PMNs 29 chemical substances which were the
subject of PMNs P-14-72, P-14-89, P-14-90, P-14-91, P-14-92, P-14-158,
P-14-159, P-14-161, P-14-162, P-14-163, P-14-173, P-14-175, P-14-176,
P-14-177, P-14-178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183,
P-14-184, P-14-185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191,
P-14-192, and P-14-193, EPA determined that one or more of the criteria
of concern established at Sec. [emsp14]721.170 were met. For
additional discussion of the rationale for the SNUR on this chemical,
see Units II., IV., and V. of the proposed rule.
B. Objectives
EPA is issuing final SNURs for 29 chemical substances described
above to achieve the following objectives with
[[Page 75814]]
regard to the significant new uses designated in this final rule:
EPA will receive notice of any person's intent to
manufacture or process a listed chemical substance for the described
significant new use before that activity begins.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
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/opptintr/existingchemicals/pubs/tscainventory/.
IV. 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 listed in this final rule, 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.
V. Applicability of the Significant New Use Designation
If uses begun after the proposed rule was published were considered
ongoing rather than new, any person could defeat the SNUR by initiating
the significant new use before the final rule was issued. Therefore EPA
has designated the date of publication of the proposed rule as the
cutoff date for determining whether the new use is ongoing. Consult the
Federal Register Notice of April 24, 1990 (55 FR 17376, FRL 3658-5) for
a more detailed discussion of the cutoff date for ongoing uses.
Any person who began commercial manufacture or processing of the
chemical substances identified in this rule for any of the significant
new uses designated in the proposed SNUR after the date of publication
of the proposed SNUR, must stop that activity before the effective date
of the final rule. Persons who ceased those activities will have to
first comply with all applicable SNUR notification requirements and
wait until the notice review period, including any extensions, expires,
before engaging in any activities designated as significant new uses.
If a person were to meet the conditions of advance compliance under 40
CFR 721.45(h), the person would be considered to have met the
requirements of the final SNUR for those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. The two
exceptions are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
Recommended testing that would address the criteria of concern of
Sec. 721.170 can be found in Unit IV. of the proposed rule.
Descriptions of tests are provided only for informational purposes. EPA
strongly encourages persons, before performing any testing, to consult
with the Agency pertaining to protocol selection.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
VII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notice requirements and EPA regulatory procedures as
persons submitting a PMN, including submission of test data on health
and environmental effects as described in Sec. 720.50. SNUNs must be
on EPA Form No. 7710-25, generated using e-PMN software, and submitted
to the Agency in accordance with the procedures set forth in Sec. Sec.
721.25 and 720.40. E-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA evaluated the potential costs of SNUN requirements for
potential manufacturers and processors of the chemical substances in
the rule. The Agency's complete Economic Analysis is available in the
docket under docket ID number EPA-HQ-OPPT-2014-0390.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
This final rule establishes SNURs for 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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval
[[Page 75815]]
number for the information collection requirements contained in this
final rule. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this final
rule.
This final rule is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit VIII.
and EPA's experience promulgating SNURs (discussed in the
certification), EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant
economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this final rule.
As such, EPA has determined that this action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
final rule does not significantly nor uniquely affect the communities
of Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this final rule.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because this is not an
economically significant regulatory action as defined by Executive
Order 12866, and this action does not address environmental health or
safety risks disproportionately affecting children.
H. Executive Order 13211
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
X. Congressional Review Act (CRA)
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: November 24, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001,
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C.
9701; 33
[[Page 75816]]
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. [emsp14]9.1, add entries for ``721.10780,'' ``721.10781,''
``721.10782,'' and ``721.10783'' in numerical order under the
undesignated center heading ``Significant New Uses of Chemical
Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB Control
40 CFR Citation No.
------------------------------------------------------------------------
* * * * *
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10780............................................... 2070-0012
721.10781............................................... 2070-0012
721.10782............................................... 2070-0012
721.10783............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. [emsp14]721.10780 to subpart E to read as follows:
Sec. [emsp14]721.10780 Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propaneperoxoic
acid, 2,2-dimethyl-, 1,1,3,3-tetramethylbutyl ester (PMN P-14-72; CAS
No. 22288-41-1) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. Add Sec. [emsp14]721.10781 to subpart E to read as follows:
Sec. 721.10781 Fatty acid amide hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acid amide hydrochlorides (PMNs P-14-89, P-14-90, P-14-91 and P-14-92)
are subject to reporting under this section for the significant new
uses described in paragraphs (a)(2) and (3) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. The significant new use is any use other
than as a surfactant in asphalt emulsions where the surface water
concentrations described under the significant new uses in paragraph
(a)(3)(i) of this section are exceeded.
(ii) [Reserved].
(3) The significant new uses for any use other than as a surfactant
in asphalt emulsions:
(i) Release to water. Requirements as specified 721.90 (a)(4),
(b)(4), and (c)(4) (where N=110 for PMNs P-14-89 and P-14-92; N=240 for
PMN P-14-90; N=53 for PMN P-14-91).
(ii) [Reserved].
(b) Specific Requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. Add Sec. [emsp14]721.10782 to subpart E to read as follows:
Sec. 721.10782 Fatty acid amides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amides (PMN P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. The significant new use is any use other
than as additives in mineral flotation products and as chemical
intermediates where the surface water concentrations described under
the significant new uses in paragraph (a)(3)(i) of this section are
exceeded.
(ii) [Reserved].
(3) The significant new uses for any use other than as additives in
mineral flotation products and as chemical intermediates:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=1 for PMNs P-14-158, P-14-
159, P-14-161, and P-14-163; N=140 for PMN P-14-162).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i) and (k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. Add Sec. [emsp14]721.10783 to subpart E to read as follows:
Sec. 721.10783 Fatty acid amide acetates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid amide acetates (PMNs P-14-173, P-14-175, P-14-176, P-14-177, P-14-
178, P-14-179, P-14-180, P-14-181, P-14-182, P-14-183, P-14-184, P-14-
185, P-14-186, P-14-187, P-14-188, P-14-190, P-14-191, P-14-192 and P-
14-193) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. The significant new use is any use other
than as flotation additives in mineral processing where the surface
water concentrations described under the significant new uses in
paragraph (a)(3)(i) of this section are exceeded.
(ii) [Reserved].
(3) The significant new uses for any use other than as flotation
additives in mineral processing:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N = concentration of concern as
follows):
[[Page 75817]]
------------------------------------------------------------------------
Concentration
PMN No. of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P-14-181, P-14- 1 ppb.
183, P-14-184, P-14-192, P-14-193.....................
P-14-176, P-14-180, P-14-185, P-14-186, P-14-187, P-14- 2 ppb.
190...................................................
P-14-177, P-14-188..................................... 3 ppb.
P-14-191............................................... 4 ppb.
P-14-182............................................... 140 ppb.
------------------------------------------------------------------------
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i) and (k) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2015-30677 Filed 12-3-15; 8:45 am]
BILLING CODE 6560-50-P
