80 FR 75812 - Significant New Use Rule on Certain Chemical Substances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 233 (December 4, 2015)

Page Range		75812-75817
FR Document		2015-30677
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.
Federal Register, Volume 80 Issue 233 (Friday, December 4, 2015)
[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Rules and Regulations]
[Pages 75812-75817]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30677]


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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.

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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 
http://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 http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. 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 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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 http://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
75812 Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations

duration occasionally between January the intended use and, if necessary, to that the shipment of the chemical
4, 2016 and February 19, 2016 to replace prohibit or limit the activity before it substance complies with all applicable
larger bridge components as long as 72- occurs. rules and orders under TSCA. Importers
hours notice is given to the USCG DATES: This final rule is effective of chemicals subject to these SNURs
District Eight Western Rivers Bridge February 2, 2016. must certify their compliance with the
Branch. ADDRESSES: The docket for this action,
SNUR requirements. The EPA policy in
The Clinton Railroad Drawbridge identified by docket identification (ID) support of import certification appears
currently operates in accordance with number EPA–HQ–OPPT–2014–0390, is at 40 CFR part 707, subpart B. In
33 CFR 117.5, which states the general available at http://www.regulations.gov addition, any persons who export or
requirement that the drawbridge shall or at the Office of Pollution Prevention intend to export a chemical substance to
open on signal. and Toxics Docket (OPPT Docket), a proposed or final rule are subject to
There are no alternate routes for Environmental Protection Agency the export notification provisions of
vessels transiting this section of the Docket Center (EPA/DC), West William TSCA section 12(b) (15 U.S.C. 2611(b))
Upper Mississippi River. The bridge Jefferson Clinton Bldg., Rm. 3334, 1301 (see § 721.20), and must comply with
cannot open in case of emergency. Constitution Ave. NW., Washington, the export notification requirements in
The Clinton Railroad Drawbridge DC. The Public Reading Room is open 40 CFR part 707, subpart D.
provides a vertical clearance of 18.7 feet from 8:30 a.m. to 4:30 p.m., Monday II. Background
above normal pool in the closed-to- through Friday, excluding legal
navigation position. Navigation on the holidays. The telephone number for the A. What action is the Agency taking?
waterway consists primarily of Public Reading Room is (202) 566–1744, EPA is finalizing SNURs, under TSCA
commercial tows and recreational and the telephone number for the OPPT section 5(a)(2), for 29 chemical
watercraft and will not be significantly Docket is (202) 566–0280. Please review substances that were the subject of
impacted. This temporary deviation has the visitor instructions and additional PMNs. This final rule requires persons
been coordinated with waterway users. information about the docket available who intend to manufacture or process
No objections were received. at http://www.epa.gov/dockets. any of these chemical substances for an
In accordance with 33 CFR 117.35(e), FOR FURTHER INFORMATION CONTACT: For activity that is designated as a
the drawbridge must return to its regular technical information contact: Kenneth significant new use to notify EPA at
operating schedule immediately at the Moss, Chemical Control Division least 90 days before commencing that
end of the effective period of this (7405M), Office of Pollution Prevention activity.
temporary deviation. This deviation and Toxics, Environmental Protection In the Federal Register of October 27,
from the operating regulations is Agency, 1200 Pennsylvania Ave. NW., 2014 (79 FR 63821) (FRL–9914–56),
authorized under 33 CFR 117.35. Washington, DC 20460–0001; telephone EPA issued a direct final SNUR for 30
Dated: November 25, 2015. number: (202) 564–9232; email address: chemical substances. EPA received
Eric A. Washburn, moss.kenneth@epa.gov. notice of intent to submit adverse
Bridge Administrator, Western Rivers. For general information contact: The comments for the direct final SNUR. In
[FR Doc. 2015–30636 Filed 12–3–15; 8:45 am]
TSCA-Hotline, ABVI-Goodwill, 422 response to that notification a rule was
South Clinton Ave., Rochester, NY proposed for the chemical substances in
BILLING CODE 9110–04–P
14620; telephone number: (202) 554– the Federal Register of June 10, 2015
1404; email address: TSCA- (80 FR 32879) (FRL–9927–60). EPA is
Hotline@epa.gov. not finalizing one of the proposed
ENVIRONMENTAL PROTECTION SNURs, as described below.
AGENCY SUPPLEMENTARY INFORMATION:
For the substance submitted as PMN
I. Does this action apply to me? P–14–72, EPA received a comment from
40 CFR Parts 9 and 721
You may be potentially affected by the PMN submitter requesting review of
[EPA–HQ–OPPT–2014–0390; FRL–9939–20] this action if you manufacture, process, a screening hydrolysis study on the
or use the chemical substances PMN substance (Organisation for
RIN 2070–AB27 Economic Co-operation and
contained in this proposed rule. The
following list of North American Development (OECD) Test Guideline
Significant New Use Rule on Certain
Industrial Classification System 111). The commenter suggested that this
Chemical Substances
(NAICS) codes is not intended to be study would aid in understanding the
AGENCY: Environmental Protection exhaustive, but rather provides a guide fate of the chemical substance and lead
Agency (EPA). to help readers determine whether this to a decision by EPA to rescind the
ACTION: Final rule. document applies to them. Potentially significant new use designation of a 3
affected entities may include: parts per billion (ppb) surface water
SUMMARY: EPA is finalizing significant • Manufacturers (including concentration limit contained in that
new use rules (SNURs) under the Toxic importers) or processors of one or more proposed SNUR. EPA completed its
Substances Control Act (TSCA) for 29 subject chemical substances (NAICS review and has determined that while
chemical substances that were the codes 325 and 324110), e.g., chemical the study satisfies the screening level
subject of premanufacture notices manufacturing and petroleum refineries. stage of the OECD 111 test protocol, it
(PMNs). This action requires persons This action may also affect certain is not the full OECD 111 study as it does
who intend to manufacture (including entities through pre-existing import not measure the hydrolysis products of
import) or process any of the chemical certification and export notification the PMN chemical substance. The
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substances for an activity that is rules under TSCA. Chemical importers purpose of OECD 111 is to determine (1)
designated as a significant new use by are subject to the TSCA section 13 (15 the rate of hydrolysis of the test
this rule to notify EPA at least 90 days U.S.C. 2612) import certification substance as a function of pH and (2)
before commencing that activity. The requirements promulgated at 19 CFR the identity or nature and rates of
required notification would provide 12.118 through 12.127 and 19 CFR formation and decline of hydrolysis
EPA with the opportunity to evaluate 127.28. Chemical importers must certify products to which organisms may be

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exposed. This test guideline is designed cited its practice of environmentally- including the four bulleted TSCA
as a tiered approach which is shown beneficial reuse and recycling in the section 5(a)(2) factors, listed in Unit IV.
and explained in the guideline. Each manufacture of these PMN substances of this rule. Once EPA determines that
tier is triggered by the results of the starting with byproducts and other a use of a chemical substance is a
previous tier. waste streams from industrial processes. significant new use, TSCA section
As stated in the proposed rule, EPA The commenter also noted that there is 5(a)(1)(B) requires persons to submit a
determined that the results of a ready no incentive to conduct any testing to significant new use notice (SNUN) to
biodegradability test with product- address the Agency’s aquatic toxicity EPA at least 90 days before they
specific chemical analytics to validate concerns, because the PMN substances manufacture or process the chemical
the degradation products (including are expected to exhibit some aquatic substance for that use. Persons who
intermediate products) and the rates of toxicity and such results may only must report are described in § 721.5.
degradation (including intermediate result in an adjustment of the water
degradation rates) and a hydrolysis as a concentration levels while the analytical C. Applicability of General Provisions
function of pH and temperature test and record-keeping burden remains. General provisions for SNURs appear
would help characterize the EPA examined the comments on these in 40 CFR part 721, subpart A. These
environmental effects of the PMN 28 chemicals and has decided to modify provisions describe persons subject to
substance P–14–72. Without additional the proposed SNURs. EPA has
the rule, recordkeeping requirements,
data identifying the hydrolysis products determined that any manufacturing,
exemptions to reporting requirements,
EPA continues to have concerns for processing or use of the substances
and applicability of the final rule to uses
toxicity at surface water concentrations excluding uses as described in the
occurring before the effective date of the
as low as 3 ppb. As a result, EPA is PMNs may result in surface water
final rule. Provisions relating to user
finalizing the SNUR as proposed and concentrations exceeding the listed
fees appear at 40 CFR part 700.
has determined that additional concentrations of concern, which may
According to § 721.1(c), persons subject
information is still necessary in order to result in significant adverse
to these SNURs must comply with the
determine whether or to what extent environmental effects. Because (1) the
same SNUN requirements and EPA
hydrolysis products may be of concern potential benefits from use of low-value
to aquatic organisms, which was the byproduct waste streams to produce the regulatory procedures as submitters of
basis for the original direct final SNUR PMN substances and (2) the Agency has PMNs under TSCA section 5(a)(1)(A). In
of October 27, 2014. Tier 3 of OECD Test determined that the uses described in particular, these requirements include
Guideline 111, the identification of the PMNs are not expected to result in the information submission
hydrolysis products, could be significant releases exceeding the listed requirements of TSCA section 5(b) and
conducted to better understand those concentrations of concern, EPA is 5(d)(1), the exemptions authorized by
products. The results of this full finalizing the SNURs on these 28 TSCA section 5(h)(1), (h)(2), (h)(3), and
hydrolysis study on PMN substance P– chemicals to limit the significant new (h)(5), and the regulations at 40 CFR
14–72 would then inform the need for use to use other than as described in the part 720. Once EPA receives a SNUN,
further recommended testing, including PMNs where the use is as a surfactant EPA may take regulatory action under
aquatic toxicity or ready in asphalt emulsions (for P–14–89 TSCA section 5(e), 5(f), 6, or 7 to control
biodegradability testing. through P–14–92); additives in mineral the activities for which it has received
EPA received comments from the flotation products and as chemical the SNUN. If EPA does not take action,
PMN submitter of the remaining 28 intermediates (for P–14–158, P–14–159, EPA is required under TSCA section
chemicals in the proposed rule. These P–14–161, P–14–162, P–14–163); or 5(g) to explain in the Federal Register
chemicals were submitted as three flotation additives in mineral processing its reasons for not taking action.
consolidated PMNs: P–14–89 through (for P–14–173, P–14–175 through P–14– III. Rationale and Objectives of the
P–14–92, P–14–158, P–14–159, P–14– 188, and P–14–190 through P–14–193). Final Rule
161, P–14–162, P–14–163, P–14–173, P– In addition, this final rule retains the
14–175 through P–14–188, and P–14– significant new use of where the surface A. Rationale
190 through P–14–193. The commenter water concentrations described under
stated that the Agency had changed its During review of the PMNs 29
the significant new uses in a new
regulatory decision on these PMN chemical substances which were the
paragraph (a)(3)(i) are exceeded, but
substances in an arbitrary and subject of PMNs P–14–72, P–14–89, P–
these water release concentrations only
capricious manner, from a SNUR with 14–90, P–14–91, P–14–92, P–14–158, P–
apply for uses other than as described
the significant new use defined as uses 14–159, P–14–161, P–14–162, P–14–
in the PMNs and mentioned in the
other than as described in the PMNs to 163, P–14–173, P–14–175, P–14–176, P–
previous sentence.
one with the significant new use EPA also received comments on the 14–177, P–14–178, P–14–179, P–14–
defined as any release of the PMN proposed SNUR for the chemical 180, P–14–181, P–14–182, P–14–183, P–
substances to surface waters resulting in substance that is the subject of PMN P– 14–184, P–14–185, P–14–186, P–14–
the quotient from the equation provided 13–793. EPA is deferring action on that 187, P–14–188, P–14–190, P–14–191, P–
in 40 CFR 721.90 exceeding a certain substance to a later date, and intends to 14–192, and P–14–193, EPA determined
surface water concentration listed in the respond to those comments and issue a that one or more of the criteria of
SNUR. Further, the commenter claimed final SNUR at that time. concern established at § 721.170 were
that a SNUR for water releases (or a met. For additional discussion of the
limit on water concentration) presents B. What is the Agency’s authority for rationale for the SNUR on this chemical,
an analytical and record-keeping burden taking this action? see Units II., IV., and V. of the proposed
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on customers for the intended PMN end Section 5(a)(2) of TSCA (15 U.S.C. rule.
uses of mineral flotation products and 2604(a)(2)) authorizes EPA to determine B. Objectives
surfactants in asphalt emulsions that that a use of a chemical substance is a
will cause the customers to instead ‘‘significant new use.’’ EPA must make EPA is issuing final SNURs for 29
select other less-environmentally this determination by rule after chemical substances described above to
beneficial products. The PMN submitter considering all relevant factors, achieve the following objectives with

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regard to the significant new uses V. Applicability of the Significant New to consult with the Agency pertaining to
designated in this final rule: Use Designation protocol selection.
• EPA will receive notice of any SNUN submitters should be aware
If uses begun after the proposed rule
person’s intent to manufacture or that EPA will be better able to evaluate
was published were considered ongoing
process a listed chemical substance for SNUNs which provide detailed
rather than new, any person could
the described significant new use before information on the following:
defeat the SNUR by initiating the • Human exposure and
that activity begins. significant new use before the final rule environmental release that may result
• EPA will have an opportunity to was issued. Therefore EPA has from the significant new use of the
review and evaluate data submitted in a designated the date of publication of the chemical substances.
SNUN before the notice submitter proposed rule as the cutoff date for • Potential benefits of the chemical
begins manufacturing or processing a determining whether the new use is substances.
listed chemical substance for the ongoing. Consult the Federal Register • Information on risks posed by the
described significant new use. Notice of April 24, 1990 (55 FR 17376, chemical substances compared to risks
• EPA will be able to regulate FRL 3658–5) for a more detailed posed by potential substitutes.
prospective manufacturers or processors discussion of the cutoff date for ongoing
uses. VII. SNUN Submissions
of a listed chemical substance before the
described significant new use of that Any person who began commercial According to 40 CFR 721.1(c), persons
chemical substance occurs, provided manufacture or processing of the submitting a SNUN must comply with
that regulation is warranted pursuant to chemical substances identified in this the same notice requirements and EPA
TSCA sections 5(e), 5(f), 6, or 7. rule for any of the significant new uses regulatory procedures as persons
designated in the proposed SNUR after submitting a PMN, including
Issuance of a SNUR for a chemical
the date of publication of the proposed submission of test data on health and
substance does not signify that the
SNUR, must stop that activity before the environmental effects as described in
chemical substance is listed on the
effective date of the final rule. Persons § 720.50. SNUNs must be on EPA Form
TSCA Chemical Substance Inventory
who ceased those activities will have to No. 7710–25, generated using e-PMN
(TSCA Inventory). Guidance on how to
first comply with all applicable SNUR software, and submitted to the Agency
determine if a chemical substance is on
notification requirements and wait until in accordance with the procedures set
the TSCA Inventory is available on the
the notice review period, including any forth in §§ 721.25 and 720.40. E–PMN
Internet at http://www.epa.gov/opptintr/
extensions, expires, before engaging in software is available electronically at
existingchemicals/pubs/tscainventory/
any activities designated as significant http://www.epa.gov/opptintr/newchems.
index.html.
new uses. If a person were to meet the VIII. Economic Analysis
IV. Significant New Use Determination conditions of advance compliance
under 40 CFR 721.45(h), the person EPA evaluated the potential costs of
Section 5(a)(2) of TSCA states that would be considered to have met the SNUN requirements for potential
EPA’s determination that a use of a requirements of the final SNUR for manufacturers and processors of the
chemical substance is a significant new those activities. chemical substances in the rule. The
use must be made after consideration of Agency’s complete Economic Analysis
all relevant factors, including: VI. Test Data and Other Information is available in the docket under docket
• The projected volume of EPA recognizes that TSCA section 5 ID number EPA–HQ–OPPT–2014–0390.
manufacturing and processing of a does not require the development of any IX. Statutory and Executive Order
chemical substance. particular test data before submission of Reviews
• The extent to which a use changes a SNUN. The two exceptions are:
the type or form of exposure of human 1. Development of test data is A. Executive Order 12866
beings or the environment to a chemical required where the chemical substance This final rule establishes SNURs for
substance. subject to the SNUR is also subject to a chemical substances that were the
• The extent to which a use increases test rule under TSCA section 4 (see subject of PMNs. The Office of
the magnitude and duration of exposure TSCA section 5(b)(1)). Management and Budget (OMB) has
of human beings or the environment to 2. Development of test data may be exempted these types of actions from
a chemical substance. necessary where the chemical substance review under Executive Order 12866,
has been listed under TSCA section entitled ‘‘Regulatory Planning and
• The reasonably anticipated manner 5(b)(4) (see TSCA section 5(b)(2)).
and methods of manufacturing, Review’’ (58 FR 51735, October 4, 1993).
In the absence of a TSCA section 4
processing, distribution in commerce, test rule or a TSCA section 5(b)(4) B. Paperwork Reduction Act (PRA)
and disposal of a chemical substance. listing covering the chemical substance, According to PRA (44 U.S.C. 3501 et
In addition to these factors persons are required only to submit test seq.), an agency may not conduct or
enumerated in TSCA section 5(a)(2), the data in their possession or control and sponsor, and a person is not required to
statute authorized EPA to consider any to describe any other data known to or respond to a collection of information
other relevant factors. reasonably ascertainable by them (see that requires OMB approval under PRA,
To determine what would constitute a § 720.50). However, upon review of unless it has been approved by OMB
significant new use for the chemical PMNs and SNUNs, the Agency has the and displays a currently valid OMB
substances listed in this final rule, EPA authority to require appropriate testing. control number. The OMB control
considered relevant information about Recommended testing that would numbers for EPA’s regulations in title 40
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the toxicity of the chemical substances, address the criteria of concern of of the CFR, after appearing in the
likely human exposures and § 721.170 can be found in Unit IV. of the Federal Register, are listed in 40 CFR
environmental releases associated with proposed rule. Descriptions of tests are part 9, and included on the related
possible uses, and the four bulleted provided only for informational collection instrument or form, if
TSCA section 5(a)(2) factors listed in purposes. EPA strongly encourages applicable. EPA is amending the table in
this unit. persons, before performing any testing, 40 CFR part 9 to list the OMB approval

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U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, § 721.125(a), (b), (c), and (k) are specified in § 721.80. The significant
1321, 1326, 1330, 1342, 1344, 1345 (d) and applicable to manufacturers and new use is any use other than as
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, processors of this substance. additives in mineral flotation products
1971–1975 Comp. p. 973; 42 U.S.C. 241, (2) Limitations or revocation of and as chemical intermediates where
242b, 243, 246, 300f, 300g, 300g–1, 300g–2, certain notification requirements. The
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
the surface water concentrations
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
provisions of § 721.185 apply to this described under the significant new
6901–6992k, 7401–7671q, 7542, 9601–9657, section. uses in paragraph (a)(3)(i) of this section
11023, 11048. ■ 5. Add § 721.10781 to subpart E to are exceeded.
read as follows: (ii) [Reserved].
■ 2. In § 9.1, add entries for
‘‘721.10780,’’ ‘‘721.10781,’’ (3) The significant new uses for any
§ 721.10781 Fatty acid amide
‘‘721.10782,’’ and ‘‘721.10783’’ in hydrochlorides (generic). use other than as additives in mineral
numerical order under the undesignated flotation products and as chemical
(a) Chemical substance and
center heading ‘‘Significant New Uses of intermediates:
significant new uses subject to reporting.
Chemical Substances’’ to read as (i) Release to water. Requirements as
(1) The chemical substances identified
follows: specified in § 721.90(a)(4), (b)(4), and
generically as fatty acid amide
(c)(4) (where N=1 for PMNs P–14–158,
hydrochlorides (PMNs P–14–89, P–14–
§ 9.1 OMB approvals under the Paperwork
90, P–14–91 and P–14–92) are subject to P–14–159, P–14–161, and P–14–163;
Reduction Act. N=140 for PMN P–14–162).
reporting under this section for the
* * * * * significant new uses described in (ii) [Reserved]
paragraphs (a)(2) and (3) of this section. (b) Specific requirements. The
40 CFR Citation OMB Control (2) The significant new uses are: provisions of subpart A of this part
No. apply to this section except as modified
(i) Industrial, commercial, and
consumer activities. Requirements as by this paragraph.
* * * * * specified in § 721.80. The significant (1) Recordkeeping. Recordkeeping
Significant New Uses of Chemical new use is any use other than as a requirements as specified in
Substances surfactant in asphalt emulsions where § 721.125(a), (b), (c), (i) and (k) are
the surface water concentrations applicable to manufacturers and
described under the significant new processors of these substances.
* * * * * uses in paragraph (a)(3)(i) of this section (2) Limitations or revocation of
721.10780 ............................. 2070–0012 certain notification requirements. The
721.10781 ............................. 2070–0012
are exceeded.
(ii) [Reserved]. provisions of § 721.185 apply to this
721.10782 ............................. 2070–0012
721.10783 ............................. 2070–0012 (3) The significant new uses for any section.
use other than as a surfactant in asphalt ■ 7. Add § 721.10783 to subpart E to
* * * * * emulsions: read as follows:
(i) Release to water. Requirements as
* * * * * specified 721.90 (a)(4), (b)(4), and (c)(4) § 721.10783 Fatty acid amide acetates
(where N=110 for PMNs P–14–89 and (generic).
PART 721—[AMENDED] P–14–92; N=240 for PMN P–14–90; (a) Chemical substance and
N=53 for PMN P–14–91). significant new uses subject to reporting.
■ 3. The authority citation for part 721 (ii) [Reserved]. (1) The chemical substance identified
continues to read as follows: (b) Specific Requirements. The generically as fatty acid amide acetates
Authority: 15 U.S.C. 2604, 2607, and provisions of subpart A of this part (PMNs P–14–173, P–14–175, P–14–176,
2625(c). apply to this section except as modified P–14–177, P–14–178, P–14–179, P–14–
by this paragraph. 180, P–14–181, P–14–182, P–14–183, P–
■ 4. Add § 721.10780 to subpart E to (1) Recordkeeping. Recordkeeping 14–184, P–14–185, P–14–186, P–14–
read as follows: requirements as specified in 187, P–14–188, P–14–190, P–14–191, P–
§ 721.10780 Propaneperoxoic acid, 2,2-
§ 721.125(a), (b), (c), (i), and (k) are 14–192 and P–14–193) are subject to
dimethyl-, 1,1,3,3-tetramethylbutyl ester. applicable to manufacturers and reporting under this section for the
processors of these substances. significant new uses described in
(a) Chemical substance and (2) Limitations or revocation of
significant new uses subject to reporting. paragraph (a)(2) of this section.
certain notification requirements. The (2) The significant new uses are:
(1) The chemical substance identified as provisions of § 721.185 apply to this
propaneperoxoic acid, 2,2-dimethyl-, (i) Industrial, commercial, and
section. consumer activities. Requirements as
1,1,3,3-tetramethylbutyl ester (PMN P– ■ 6. Add § 721.10782 to subpart E to
14–72; CAS No. 22288–41–1) is subject specified in § 721.80. The significant
read as follows:
to reporting under this section for the new use is any use other than as
significant new uses described in § 721.10782 Fatty acid amides (generic). flotation additives in mineral processing
paragraph (a)(2) of this section. (a) Chemical substance and where the surface water concentrations
(2) The significant new uses are: significant new uses subject to reporting. described under the significant new
(i) Release to water. Requirements as (1) The chemical substance identified uses in paragraph (a)(3)(i) of this section
specified in § 721.90 (a)(4), (b)(4), and generically as fatty acid amides (PMN are exceeded.
(c)(4) (N=3). P–14–158, P–14–159, P–14–161, P–14– (ii) [Reserved].
(ii) [Reserved] 162, and P–14–163) are subject to (3) The significant new uses for any
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(b) Specific requirements. The reporting under this section for the use other than as flotation additives in
provisions of subpart A of this part significant new uses described in mineral processing:
apply to this section except as modified paragraph (a)(2) of this section. (i) Release to water. Requirements as
by this paragraph. (2) The significant new uses are: specified in § 721.90(a)(4), (b)(4), and
(1) Recordkeeping. Recordkeeping (i) Industrial, commercial, and (c)(4) (where N = concentration of
requirements as specified in consumer activities. Requirements as concern as follows):

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Federal Register / Vol. 80, No. 233 / Friday, December 4, 2015 / Rules and Regulations 75817

Concentration email address: nizich.sharon@epa.gov. DEPARTMENT OF HEALTH AND
PMN No. of concern For information about the applicability HUMAN SERVICES
of the national emission standards for
P–14–173, P–14–175, P– 45 CFR Part 95
hazardous air pollutants, contact Mr.
14–178, P–14–179, P–
14–181, P–14–183, P– Patrick Yellin, Monitoring, Assistance
and Media Programs Division (2227A), Centers for Medicare & Medicaid
14–184, P–14–192, P–
14–193 ............................ 1 ppb. Office of Enforcement and Compliance Services
P–14–176, P–14–180, P– Assurance, U.S. Environmental
14–185, P–14–186, P– Protection Agency, 1200 Pennsylvania 42 CFR Part 433
14–187, P–14–190 .......... 2 ppb. Avenue, Washington, DC 20460; [CMS–2392–F]
P–14–177, P–14–188 ......... 3 ppb.
P–14–191 ........................... 4 ppb.
telephone number (202) 564–2970;
email address yellin.patrick@epa.gov. RIN 0938–AS53
P–14–182 ........................... 140 ppb.
SUPPLEMENTARY INFORMATION: The EPA Medicaid Program; Mechanized Claims
(ii) [Reserved] published a document in the Federal Processing and Information Retrieval
(b) Specific requirements. The Register of October 26, 2015 (80 FR Systems (90/10)
provisions of subpart A of this part 65470). There were two errors included
apply to this section except as modified AGENCY: Centers for Medicare &
in the final rule. First, the reference to Medicaid Services (CMS), HHS.
by this paragraph.
the IBR method (ASTM D6348–03) was
(1) Recordkeeping. Recordkeeping ACTION: Final rule.
incorrect. The incorrect IBR method
requirements as specified in
§ 721.125(a), (b), (c), (i) and (k) are reference included in the Federal SUMMARY: This final rule will extend
applicable to manufacturers and Register was paragraph (h)(75). The enhanced funding for Medicaid
processors of these substances. correct reference is paragraph (h)(76). eligibility systems as part of a state’s
(2) Limitations or revocation of Second, there was a typographical error mechanized claims processing system,
certain notification requirements. The in 40 CFR 63.8605(c) referencing a and will update conditions and
provisions of § 721.185 apply to this requirement of a non-existing section. standards for such systems, including
section. The incorrect non-existing reference is adding to and updating current
40 CFR 63.8630(e). The correct reference Medicaid Management Information
[FR Doc. 2015–30677 Filed 12–3–15; 8:45 am]
is 40 CFR 63.8630(c). Systems (MMIS) conditions and
BILLING CODE 6560–50–P
standards. These changes will allow
Correction states to improve customer service and
ENVIRONMENTAL PROTECTION support the dynamic nature of Medicaid
In rule FR Doc. 2015–25724 published
AGENCY eligibility, enrollment, and delivery
on October 26, 2015 (80 FR 65470),
systems.
make the following corrections:
40 CFR Part 63 DATES: Effective Date: These regulations
§ 63.14 [Corrected] are effective on January 1, 2016.
[EPA–HQ–OAR–2013–0290 and EPA–HQ–
OAR–2013–0291; FRL–9939–35–OAR] ■ 1. On page 65520: FOR FURTHER INFORMATION CONTACT:
RIN 2060–AP69
Victoria Guarisco (410) 786–0265, for
■ a. In the second column, correct issues related to administrative
amendatory instruction number 2.b. to questions.
NESHAP for Brick and Structural Clay
read ‘‘Revising paragraph (h)(76);’’. Carrie Feher (410) 786–8905, for
Products Manufacturing; and NESHAP
for Clay Ceramics Manufacturing: ■ b. In the second column, redesignate issues related to the regulatory impact
Correction paragraph (h)(75) as paragraph (h)(76). analysis.
Christine Gerhardt (410) 786–0693 or
AGENCY: Environmental Protection § 63.8605 [Corrected] Martin Rice (410) 786–2417, for general
Agency (EPA). questions.
■ 2. On page 65549, second column, in
ACTION: Final rule; correction. SUPPLEMENTARY INFORMATION:
paragraph (c), fifth line, remove
SUMMARY: The Environmental Protection ‘‘§ 63.8630(e).’’ and add ‘‘§ 63.8630(c).’’ Table of Contents
Agency (EPA) published a final rule in in its place.
I. Executive Summary
the Federal Register on October 26, Dated: November 18, 2015. A. Purpose
2015, titled NESHAP for Brick and Janet G. McCabe, B. Summary of the Major Provisions
Structural Clay Products Manufacturing; C. Summary of Costs and Benefits
and NESHAP for Clay Ceramics Acting Assistant Administrator, Office of Air II. Background
and Radiation. A. Legislative History and Statutory
Manufacturing. These amendments
[FR Doc. 2015–30379 Filed 12–3–15; 8:45 am] Authority
make two technical corrections to the
published regulation. BILLING CODE 6560–50–P B. Program Affected
III. Provisions of the Proposed Rule and
DATES: This action is effective December Responses to Comments
28, 2015. A. Amendments to 42 CFR Part 433
FOR FURTHER INFORMATION CONTACT: Ms. B. Technical Changes to 42 CFR Part 433,
Sharon Nizich, Sector Policies and Subpart C-Mechanized Claims and
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Programs Division (D243–04), Office of Processing Information Retrieval
Systems
Air Quality Planning and Standards, C. Changes to 45 CFR Part 95—General
U.S. Environmental Protection Agency, Administration—Grant Programs,
Research Triangle Park, North Carolina Subpart F
27711, telephone number: (919) 541– IV. Provisions of the Final Regulations
2825; facsimile number: (919) 541–5450; V. Collection of Information Requirements

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Document Created: 2015-12-14 13:52:39
Document Modified: 2015-12-14 13:52:39
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This final rule is effective February 2, 2016.
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:
FR Citation		80 FR 75812
RIN Number		2070-AB27
CFR Citation		40 CFR 721 40 CFR 9
CFR Associated		Chemicals; Hazardous Substances; Environmental Protection and Reporting and Recordkeeping Requirements