80_FR_32990 80 FR 32879 - Significant New Use Rule on Certain Chemical Substances

80 FR 32879 - Significant New Use Rule on Certain Chemical Substances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 111 (June 10, 2015)

Page Range32879-32885
FR Document2015-13941

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 30 chemical substances which were the subject of premanufacture notices (PMNs). This action would require 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 proposed 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 111 (Wednesday, June 10, 2015)
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32879-32885]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13941]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2014-0390; FRL-9927-60]
RIN 2070-AB27


Significant New Use Rule on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 30 chemical substances which 
were the subject of premanufacture notices (PMNs). This action would 
require 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 proposed 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: Comments must be received on or before July 10, 2015.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2014-0390, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
    Follow the online instructions for submitting comments. Do not 
submit electronically any information you consider to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this 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.  721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark

[[Page 32880]]

the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD-ROM that you mail to EPA, mark the outside 
of the disk or CD-ROM as CBI and then identify electronically within 
the disk or CD-ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 30 
chemical substances which were the subject of PMNs P-13-793, 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. 
These SNURs would require persons who intend to manufacture or process 
any of these chemical substances for an activity that is designated as 
a significant new use to notify EPA at least 90 days before commencing 
that activity. In accordance with the procedures at Sec.  
721.160(c)(3)(i), in the Federal Register publication of October 27, 
2014 (79 FR 63821) (FRL-9914-56) EPA issued direct final SNURs on these 
chemical substances, which are the subject of PMNs. EPA received 
notices of intent to submit adverse comments on these SNURs. Therefore, 
as required by Sec.  721.160(c)(3)(ii), EPA withdrew the direct final 
SNURs in the Federal Register of December 23, 2014 (79 FR 76900) (FRL-
9920-6325), and is now issuing this proposed rule on these 30 chemical 
substances. The records for the direct final SNURs on these 30 chemical 
substances were established as docket EPA-HQ-OPPT-2014-0390. Those 
records include information considered by the Agency in developing the 
direct final rule. Adverse comments received regarding these substances 
and the direct final rule are discussed in Unit IV.

B. What is the Agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use. 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 rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA 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. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 30 chemical substances in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (assigned 
for non-confidential chemical identities).
     Public comments and EPA's response to comments on the 30 
direct final SNURs subject to PMNs P-13-793, 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
     Basis for the TSCA non-section 5(e) SNURs (i.e., SNURs 
without TSCA section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including production volume limits (i.e., limits on manufacture and 
importation volume) and other uses designated in this proposed rule, 
may be claimed as CBI.

PMN Number P-13-793

    Chemical name: Functionalized carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Public comment: A notice of intent to adversely comment has been 
submitted.
    EPA response: EPA awaits the adverse comment during the open 
comment

[[Page 32881]]

period for this notice of proposed rulemaking.
    Basis for action: The PMN states that the substance will be used as 
a thin film for electronic device applications. Based on structure 
activity relationship (SAR) analysis of test data on analogous carbon 
nanotubes and other respirable poorly soluble particulates, EPA 
identified potential lung effects, developmental toxicity, and dermal 
toxicity from exposure to the PMN substance via inhalation, dermal, and 
oral routes. Further, EPA predicts toxicity to aquatic organisms via 
releases of the PMN substance to surface water. Although there is 
potential for dermal exposure, EPA does not expect significant 
occupational exposures due to the use of impervious gloves, and because 
the PMN is used in liquid form and is not spray applied. Further, EPA 
does not expect environmental releases during the use identified in the 
PMN submission. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk human health or the environment. EPA has determined, 
however, that any use of the substance without the use of impervious 
gloves, where there is a potential for dermal exposure; manufacturing 
the PMN substance for use other than as a thin film for electronic 
device applications; manufacturing, processing, or using the PMN 
substance in a form other than a liquid; use of the PMN substance 
involving an application method that generates a mist, vapor, or 
aerosol; or any release of the PMN substance into surface waters may 
cause serious health effects or significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria in Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an oral 
and inhalation pharmacokinetic test (OPPTS Test Guideline 870.7485); a 
90-day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); an algal 
toxicity test (OCSPP Test Guideline 850.4500); and a surface charge by 
electrophoresis by either the (ASTM Test Guideline E2865-12) or 
measuring the zeta potential of nanoparticles (Nanotechnology 
Characterization Library (NCL) Method PCC-2) (located in the Docket 
under Docket ID number EPA-HQ-OPPT-2014-0390); would help characterize 
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10776.

PMN Number P-14-72

    Chemical name: Propaneperoxoic acid, 2,2-dimethyl-, 1,1,3,3-
tetramethylbutyl ester.
    CAS number: 22288-41-1.
    Public comment: A notice of intent to adversely comment has been 
submitted.
    EPA response: EPA awaits the adverse comment during the open 
comment period for this notice of proposed rulemaking.
    Basis for action: The PMN states that the use of the substance will 
be as a polymerization initiator for the production of polyvinyl 
chloride (PVC) and polyethylene resin. Based on test data on the PMN 
substance, as well as ecological SAR analysis of test data on analogous 
peroxy esters, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 3 parts per billion (ppb) of the PMN 
substance in surface waters. As described in the PMN, releases of the 
substance are not expected to result in surface water concentrations 
that exceed 3 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface waters concentrations exceeding 3 ppb 
may result in significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (Organisation for Economic Co-operation and 
Development (OECD) Test Guideline 301C) 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 (OPPTS Test Guideline 835.2130) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10780.

PMN Numbers P-14-89, P-14-90, P-14-91, and P-14-92

    Chemical names: Fatty acid amide hydrochlorides (generic).
    CAS numbers: Claimed confidential.
    Public comment: A notice of intent to adversely comment has been 
submitted, by the PMN submitter. The comment expressed concern that 
EPA's approach for these SNURs changed from that transmitted in writing 
by EPA during the PMN review period. As a result, the PMN submitter was 
not given the opportunity to discuss, provide pertinent information on, 
respond to, or comment on this change.
    EPA response: EPA met with the PMN submitter on December 17, 2014 
to discuss procedural and policy issues raised in connection with the 
withdrawn SNURs. EPA awaits formal comment during the open comment 
period for this proposed rule.
    Basis for action: The consolidated PMN states that the substances 
will be used as surfactants for use in asphalt emulsions. Based on 
ecological SAR analysis of test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed the following values of the PMN substances in surface waters:

------------------------------------------------------------------------
                 PMN No.                     Concentration  of concern
------------------------------------------------------------------------
P-14-89, P-14-92.........................  110 ppb.
P-14-90..................................  240 ppb.
P-14-91..................................  53 ppb.
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern may result in significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed.
    CFR citation: 40 CFR 721.10781.

PMN Numbers P-14-158, P-14-159, P-14-161, P-14-162, and P-14-163

    Chemical names: Fatty acid amides (generic).
    CAS numbers: Claimed confidential.
    Public comment: A notice of intent to adversely comment has been 
submitted,

[[Page 32882]]

by the PMN submitter. The comment expressed concern that EPA's approach 
for these SNURs changed from that transmitted in writing by EPA during 
the PMN review period. As a result, the PMN submitter was not given the 
opportunity to discuss, provide pertinent information on, respond to, 
or comment on this change.
    EPA response: EPA met with the PMN submitter on December 17, 2014 
to discuss procedural and policy issues raised in connection with the 
withdrawn SNURs. EPA awaits formal comment during the open comment 
period for this proposed rule.
    Basis for action: The consolidated PMN states that the substances 
will be used as chemical intermediates and additives for flotation 
products. Based on ecological SAR analysis of test data on analogous 
amides and aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed the following values of the PMN 
substances in surface waters:

------------------------------------------------------------------------
                 PMN No.                     Concentration  of concern
------------------------------------------------------------------------
P-14-158, P-14-159, P-14-161, P-14-163...  1 ppb.
P-14-162.................................  140 ppb.
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern may result in significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of (1) a 
water solubility: Column elution method; shake flask method test (OPPTS 
Test Guideline 830.7840) or a water solubility generator column method 
test (OPPTS Test Guideline 830.7860); and (2) a determination of the 
partition coefficient (n-octanol/water) by shake flask method (OPPTS 
Test Guideline 830.7550), or generator column method (OPPTS Test 
Guideline 830.7560), or estimation by liquid chromatography (OPPTS Test 
Guideline 830.7570) would help characterize the physical/chemical 
properties of the PMN substances. Depending upon the results of these 
data, the results of a fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300); and an algal toxicity test (OCSPP Test Guideline 
850.4500) may be recommended to help characterize the environmental 
effects of the PMN substances.
    CFR citation: 40 CFR 721.10782.

PMN Numbers 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

    Chemical names: Fatty acid amide acetates (generic).
    CAS numbers: Claimed confidential.
    Public comment: A notice of intent to adversely comment has been 
submitted, by the PMN submitter. The comment expressed concern that 
EPA's approach for these SNURs changed from that transmitted in writing 
by EPA during the PMN review period. As a result, the PMN submitter was 
not given the opportunity to discuss, provide pertinent information on, 
respond to, or comment on this change.
    EPA response: EPA met with the PMN submitter on December 17, 2014 
to discuss procedural and policy issues raised in connection with the 
withdrawn SNURs. EPA awaits formal comment during the open comment 
period for this proposed rule.
    Basis for action: The PMNs state that the substances will be used 
as flotation additives for use in mineral processing. Based on 
ecological SAR analysis of test data on analogous amides and aliphatic 
amines, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed the following values of the PMN substances 
in surface waters:

------------------------------------------------------------------------
                 PMN No.                      Concentration of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
 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- 2 ppb.
 14-187, P-14-190.
P-14-177, P-14-188.......................  3 ppb.
P-14-191.................................  4 ppb.
P-14-182.................................  140 ppb.
------------------------------------------------------------------------

    For the use described in the PMNs, releases of the substances are 
not expected to result in surface water concentrations that exceed 
these values. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in surface water concentrations exceeding the 
aforementioned concentrations of concern may result in significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) on P-14-184, and any one of the 
remaining PMN substances, would help characterize the environmental 
effects of the PMN substances. Further, EPA determined that the results 
of a fish acute toxicity mitigated by humic acid test (OPPTS Test 
Guideline 850.1085) on PMN P-14-184 would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed.
    CFR citation: 40 CFR 721.10783.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA determined that one or more of the 
criteria of concern established at Sec.  [emsp14]721.170 were met. For 
additional discussion on these chemical substances, see Units II. and 
IV. of this proposed rule.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would be able to regulate prospective manufacturers or 
processors of a listed chemical substance before the

[[Page 32883]]

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.

VI. Applicability of the Proposed Rule to Uses Occurring Before the 
Effective Date of the Final Rule

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. The identities of 29 of the 30 chemical 
substances subject to this proposed rule have been claimed as 
confidential and EPA has received no post-PMN bona fide submissions 
(per Sec. Sec.  720.25 and 721.11). Based on this, the Agency believes 
that it is highly unlikely that any of the significant new uses 
described in the regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates June 10, 2015 as the cutoff date for 
determining whether the new use is ongoing. Persons who begin 
commercial manufacture or processing of the chemical substances for a 
significant new use identified as of that date would have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons would have to first comply with all 
applicable SNUR notification requirements and wait until the notice 
review period, including any extensions, expires. If such a person met 
the conditions of advance compliance under Sec.  721.45(h), the person 
would be considered exempt from the requirements of the SNUR. Consult 
the Federal Register document of April 24, 1990 (55 FR 17376) for a 
more detailed discussion of the cutoff date for ongoing uses.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (see 40 CFR 
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at 
http://www.sourceoecd.org. ASTM International standards are available 
at http://www.astm.org/Standard/index.shtml.
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    According to Sec.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notification requirements and EPA regulatory 
procedures as persons submitting a PMN, including submission of test 
data on health and environmental effects as described in 40 CFR 720.50. 
SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule, during the development of the 
direct final rule. EPA's complete economic analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2014-0390.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for 30 chemical substances 
that were the subject of PMNs. The Office of Management and Budget 
(OMB) has exempted these types of actions from review under Executive 
Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This proposed rule would 
not impose any burden requiring additional OMB approval. If an entity 
were to

[[Page 32884]]

submit a SNUN to the Agency, the annual burden is estimated to average 
between 30 and 170 hours per response. This burden estimate includes 
the time needed to review instructions, search existing data sources, 
gather and maintain the data needed, and complete, review, and submit 
the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
proposed rule.
    This proposed rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit IX. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.
    Therefore, the promulgation of the SNUR would not have a 
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This proposed rule would not have a substantial direct effect on 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled ``Federalism'' (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this proposed rule.

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this proposed rule does not address environmental 
health or safety risks disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this proposed rule would not involve any 
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would 
not apply to this proposed rule.

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: June 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  721.10776 to subpart E to read as follows:


Sec.  721.10776  Functionalized carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
functionalized carbon nanotubes (PMN P-13-793) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the PMN substance after they have been completely 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), and (a)(3). When determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63 
(a)(1), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (a significant new use is use other 
than as a thin film for electronic device applications), (v)(1), 
(v)(2), (w)(1), (w)(2), (x)(1), (x)(2), and (y)(1).

[[Page 32885]]

    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e), (i), 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
3. Add Sec.  721.10780 to subpart E to read as follows:


Sec.  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
4. Add Sec.  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 substance 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 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) (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), 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
5. Add Sec.  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) 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), 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.  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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (where N = concentration of concern as 
follows):

------------------------------------------------------------------------
                 PMN No.                     Concentration  of concern
------------------------------------------------------------------------
P-14-173, P-14-175, P-14-178, P-14-179, P- 1 ppb.
 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- 2 ppb.
 14-187, P-14-190.
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), 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. 2015-13941 Filed 6-9-15; 8:45 am]
 BILLING CODE 6560-50-P



                                                                            Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules                                                    32879

                                                      Nitrogen dioxide, Ozone, Particulate                      Chapter I, title 40 of the Code of                    Subpart R—KANSAS
                                                      matter, Reporting and recordkeeping                     Federal Regulations is amended as
                                                      requirements, Sulfur oxides, Volatile                   follows:                                                ■ 2. In § 52.870 the table in paragraph
                                                      organic compounds.                                                                                              (e) is amended by adding new entry (40)
                                                                                                              PART 52—APPROVAL AND                                    at the end of the table to read as follows:
                                                       Dated: May 28, 2015.
                                                                                                              PROMULGATION OF
                                                      Mark Hague,
                                                                                                              IMPLEMENTATION PLANS                                    § 52.870   Identification of plan.
                                                      Acting Regional Administrator, Region 7.
                                                                                                                                                                      *       *    *      *     *
                                                        For the reasons stated in the                         ■ 1. The authority citation for part 52
                                                                                                              continues to read as follows:                               (e) * * *
                                                      preamble, EPA proposes to amend 40
                                                      CFR part 52 as set forth below:                             Authority: 42 U.S.C. 7401 et. seq.

                                                                                                   EPA-APPROVED KANSAS NONREGULATORY PROVISIONS
                                                                                                                                                         State
                                                                                                                    Applicable geographic or
                                                              Name of nonregulatory SIP provision                                                      submittal      EPA approval date             Explanation
                                                                                                                      Nonattainment area                 date


                                                                *                  *                   *                       *                                 *                   *                     *
                                                      (40) State Implementation Plan (SIP) Revision for Statewide .......................                 3/10/15 6/10/15 [Insert Federal
                                                        the Attainment and Maintenance of National Am-                                                              Register citation].
                                                        bient Air Quality Standards for Regional Haze
                                                        (2014 Five-Year Progress Report)



                                                      [FR Doc. 2015–13943 Filed 6–9–15; 8:45 am]                Follow the online instructions for                    contained in this proposed rule. The
                                                      BILLING CODE 6560–50–P                                  submitting comments. Do not submit                      following list of North American
                                                                                                              electronically any information you                      Industrial Classification System
                                                                                                              consider to be Confidential Business                    (NAICS) codes is not intended to be
                                                      ENVIRONMENTAL PROTECTION                                Information (CBI) or other information                  exhaustive, but rather provides a guide
                                                      AGENCY                                                  whose disclosure is restricted by statute.              to help readers determine whether this
                                                                                                                • Mail: Document Control Office                       document applies to them. Potentially
                                                      40 CFR Part 721                                         (7407M), Office of Pollution Prevention                 affected entities may include:
                                                      [EPA–HQ–OPPT–2014–0390; FRL–9927–60]                    and Toxics (OPPT), Environmental                           • Manufacturers (including
                                                                                                              Protection Agency, 1200 Pennsylvania                    importers) or processors of one or more
                                                      RIN 2070–AB27                                           Ave. NW., Washington, DC 20460–0001.                    subject chemical substances (NAICS
                                                                                                                • Hand Delivery: To make special                      codes 325 and 324110), e.g., chemical
                                                      Significant New Use Rule on Certain                     arrangements for hand delivery or                       manufacturing and petroleum refineries.
                                                      Chemical Substances                                     delivery of boxed information, please                      This action may also affect certain
                                                      AGENCY:  Environmental Protection                       follow the instructions at http://                      entities through pre-existing import
                                                      Agency (EPA).                                           www.epa.gov/dockets/contacts.html.                      certification and export notification
                                                                                                                Additional instructions on                            rules under TSCA. Chemical importers
                                                      ACTION: Proposed rule.                                                                                          are subject to the TSCA section 13 (15
                                                                                                              commenting or visiting the docket,
                                                      SUMMARY:   EPA is proposing significant                 along with more information about                       U.S.C. 2612) import certification
                                                      new use rules (SNURs) under the Toxic                   dockets generally, is available at                      requirements promulgated at 19 CFR
                                                      Substances Control Act (TSCA) for 30                    http://www.epa.gov/dockets.                             12.118 through 12.127 and 19 CFR
                                                      chemical substances which were the                      FOR FURTHER INFORMATION CONTACT: For                    127.28. Chemical importers must certify
                                                      subject of premanufacture notices                       technical information contact: Kenneth                  that the shipment of the chemical
                                                      (PMNs). This action would require                       Moss, Chemical Control Division                         substance complies with all applicable
                                                      persons who intend to manufacture                       (7405M), Office of Pollution Prevention                 rules and orders under TSCA. Importers
                                                      (including import) or process any of the                and Toxics, Environmental Protection                    of chemicals subject to these SNURs
                                                      chemical substances for an activity that                Agency, 1200 Pennsylvania Ave. NW.,                     must certify their compliance with the
                                                      is designated as a significant new use by               Washington, DC 20460–0001; telephone                    SNUR requirements. The EPA policy in
                                                      this proposed rule to notify EPA at least               number: (202) 564–9232; email address:                  support of import certification appears
                                                      90 days before commencing that                          moss.kenneth@epa.gov.                                   at 40 CFR part 707, subpart B. In
                                                      activity. The required notification                       For general information contact: The                  addition, any persons who export or
                                                      would provide EPA with the                              TSCA-Hotline, ABVI-Goodwill, 422                        intend to export a chemical substance to
                                                      opportunity to evaluate the intended                    South Clinton Ave., Rochester, NY                       a proposed or final rule are subject to
                                                      use and, if necessary, to prohibit or limit             14620; telephone number: (202) 554–                     the export notification provisions of
                                                                                                                                                                      TSCA section 12(b) (15 U.S.C. 2611(b))
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      the activity before it occurs.                          1404; email address: TSCA-Hotline@
                                                                                                              epa.gov.                                                (see § 721.20), and must comply with
                                                      DATES: Comments must be received on
                                                                                                                                                                      the export notification requirements in
                                                      or before July 10, 2015.                                SUPPLEMENTARY INFORMATION:
                                                                                                                                                                      40 CFR part 707, subpart D.
                                                      ADDRESSES: Submit your comments,                        I. General Information
                                                      identified by docket identification (ID)                                                                        B. What should I consider as I prepare
                                                      number EPA–HQ–OPPT–2014–0390, by                        A. Does this action apply to me?                        my comments for EPA?
                                                      one of the following methods:                             You may be potentially affected by                      1. Submitting CBI. Do not submit this
                                                         • Federal eRulemaking Portal: http://                this action if you manufacture, process,                information to EPA through
                                                      www.regulations.gov.                                    or use the chemical substances                          regulations.gov or email. Clearly mark


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00013   Fmt 4702   Sfmt 4702    E:\FR\FM\10JNP1.SGM   10JNP1


                                                      32880                 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules

                                                      the part or all of the information that                 B. What is the Agency’s authority for                  processing, distribution in commerce,
                                                      you claim to be CBI. For CBI                            taking this action?                                    and disposal of a chemical substance.
                                                      information in a disk or CD–ROM that                       Section 5(a)(2) of TSCA (15 U.S.C.                    In addition to these factors
                                                      you mail to EPA, mark the outside of the                2604(a)(2)) authorizes EPA to determine                enumerated in TSCA section 5(a)(2), the
                                                      disk or CD–ROM as CBI and then                          that a use of a chemical substance is a                statute authorized EPA to consider any
                                                      identify electronically within the disk or              ‘‘significant new use.’’ EPA must make                 other relevant factors.
                                                      CD–ROM the specific information that                                                                             To determine what would constitute a
                                                                                                              this determination by rule after
                                                      is claimed as CBI. In addition to one                                                                          significant new use for the chemical
                                                                                                              considering all relevant factors,
                                                      complete version of the comment that                                                                           substances that are the subject of these
                                                                                                              including the four bulleted TSCA
                                                      includes information claimed as CBI, a                                                                         SNURs, EPA considered relevant
                                                                                                              section 5(a)(2) factors listed in Unit III.
                                                                                                                                                                     information about the toxicity of the
                                                      copy of the comment that does not                       Once EPA determines that a use of a
                                                                                                                                                                     chemical substances, likely human
                                                      contain the information claimed as CBI                  chemical substance is a significant new
                                                                                                                                                                     exposures and environmental releases
                                                      must be submitted for inclusion in the                  use, TSCA section 5(a)(1)(B) requires
                                                                                                                                                                     associated with possible uses, and the
                                                      public docket. Information so marked                    persons to submit a significant new use
                                                                                                                                                                     four bulleted TSCA section 5(a)(2)
                                                      will not be disclosed except in                         notice (SNUN) to EPA at least 90 days
                                                                                                                                                                     factors listed in this unit.
                                                      accordance with procedures set forth in                 before they manufacture or process the
                                                      40 CFR part 2.                                          chemical substance for that use. Persons               IV. Substances Subject to This Proposed
                                                                                                              who must report are described in                       Rule
                                                         2. Tips for preparing your comments.
                                                                                                              § 721.5.                                                  EPA is proposing significant new use
                                                      When preparing and submitting your
                                                      comments, see the commenting tips at                    C. Applicability of General Provisions                 and recordkeeping requirements for 30
                                                      http://www.epa.gov/dockets/                                                                                    chemical substances in 40 CFR part 721,
                                                                                                                 General provisions for SNURs appear
                                                      comments.html.                                                                                                 subpart E. In this unit, EPA provides the
                                                                                                              in 40 CFR part 721, subpart A. These
                                                                                                                                                                     following information for each chemical
                                                      II. Background                                          provisions describe persons subject to
                                                                                                                                                                     substance:
                                                                                                              the rule, recordkeeping requirements,                     • PMN number.
                                                      A. What action is the Agency taking?                    exemptions to reporting requirements,                     • Chemical name (generic name, if
                                                                                                              and applicability of the rule to uses                  the specific name is claimed as CBI).
                                                         EPA is proposing these SNURs under                   occurring before the effective date of the
                                                      TSCA section 5(a)(2) for 30 chemical                                                                              • Chemical Abstracts Service (CAS)
                                                                                                              final rule. Provisions relating to user                Registry number (assigned for non-
                                                      substances which were the subject of                    fees appear at 40 CFR part 700.                        confidential chemical identities).
                                                      PMNs P–13–793, P–14–72, P–14–89, P–                     According to § 721.1(c), persons subject                  • Public comments and EPA’s
                                                      14–90, P–14–91, P–14–92, P–14–158, P–                   to these SNURs must comply with the                    response to comments on the 30 direct
                                                      14–159, P–14–161, P–14–162, P–14–                       same SNUN requirements and EPA                         final SNURs subject to PMNs P–13–793,
                                                      163, P–14–173, P–14–175, P–14–176, P–                   regulatory procedures as submitters of                 P–14–72, P–14–89, P–14–90, P–14–91,
                                                      14–177, P–14–178, P–14–179, P–14–                       PMNs under TSCA section 5(a)(1)(A). In                 P–14–92, P–14–158, P–14–159, P–14–
                                                      180, P–14–181, P–14–182, P–14–183, P–                   particular, these requirements include                 161, P–14–162, P–14–163, P–14–173, P–
                                                      14–184, P–14–185, P–14–186, P–14–                       the information submission                             14–175, P–14–176, P–14–177, P–14–
                                                      187, P–14–188, P–14–190, P–14–191, P–                   requirements of TSCA section 5(b) and                  178, P–14–179, P–14–180, P–14–181, P–
                                                      14–192, and P–14–193. These SNURs                       5(d)(1), the exemptions authorized by                  14–182, P–14–183, P–14–184, P–14–
                                                      would require persons who intend to                     TSCA section 5(h)(1), (h)(2), (h)(3), and              185, P–14–186, P–14–187, P–14–188, P–
                                                      manufacture or process any of these                     (h)(5), and the regulations at 40 CFR                  14–190, P–14–191, P–14–192, and P–
                                                      chemical substances for an activity that                part 720. Once EPA receives a SNUN,                    14–193
                                                      is designated as a significant new use to               EPA may take regulatory action under                      • Basis for the TSCA non-section 5(e)
                                                      notify EPA at least 90 days before                      TSCA section 5(e), 5(f), 6, or 7 to control            SNURs (i.e., SNURs without TSCA
                                                      commencing that activity. In accordance                 the activities for which it has received               section 5(e) consent orders).
                                                      with the procedures at § 721.160(c)(3)(i),              the SNUN. If EPA does not take action,                    • Tests recommended by EPA to
                                                      in the Federal Register publication of                  EPA is required under TSCA section                     provide sufficient information to
                                                      October 27, 2014 (79 FR 63821) (FRL–                    5(g) to explain in the Federal Register                evaluate the chemical substance (see
                                                      9914–56) EPA issued direct final SNURs                  its reasons for not taking action.                     Unit VII. for more information).
                                                      on these chemical substances, which are                                                                           • CFR citation assigned in the
                                                                                                              III. Significant New Use Determination
                                                      the subject of PMNs. EPA received                                                                              regulatory text section of this proposed
                                                                                                                 Section 5(a)(2) of TSCA states that                 rule.
                                                      notices of intent to submit adverse
                                                                                                              EPA’s determination that a use of a                       The regulatory text section of this
                                                      comments on these SNURs. Therefore,
                                                                                                              chemical substance is a significant new                proposed rule specifies the activities
                                                      as required by § 721.160(c)(3)(ii), EPA
                                                                                                              use must be made after consideration of                designated as significant new uses.
                                                      withdrew the direct final SNURs in the                  all relevant factors, including:
                                                      Federal Register of December 23, 2014                                                                          Certain new uses, including production
                                                                                                                 • The projected volume of                           volume limits (i.e., limits on
                                                      (79 FR 76900) (FRL–9920–6325), and is                   manufacturing and processing of a                      manufacture and importation volume)
                                                      now issuing this proposed rule on these                 chemical substance.                                    and other uses designated in this
                                                      30 chemical substances. The records for                    • The extent to which a use changes
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                                                                                                                                     proposed rule, may be claimed as CBI.
                                                      the direct final SNURs on these 30                      the type or form of exposure of human
                                                      chemical substances were established as                 beings or the environment to a chemical                PMN Number P–13–793
                                                      docket EPA–HQ–OPPT–2014–0390.                           substance.                                               Chemical name: Functionalized
                                                      Those records include information                          • The extent to which a use increases               carbon nanotubes (generic).
                                                      considered by the Agency in developing                  the magnitude and duration of exposure                   CAS number: Claimed confidential.
                                                      the direct final rule. Adverse comments                 of human beings or the environment to                    Public comment: A notice of intent to
                                                      received regarding these substances and                 a chemical substance.                                  adversely comment has been submitted.
                                                      the direct final rule are discussed in                     • The reasonably anticipated manner                   EPA response: EPA awaits the adverse
                                                      Unit IV.                                                and methods of manufacturing,                          comment during the open comment


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00014   Fmt 4702   Sfmt 4702   E:\FR\FM\10JNP1.SGM   10JNP1


                                                                            Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules                                                          32881

                                                      period for this notice of proposed                        CFR citation: 40 CFR 721.10776.                      PMN submitter was not given the
                                                      rulemaking.                                                                                                    opportunity to discuss, provide
                                                         Basis for action: The PMN states that                PMN Number P–14–72
                                                                                                                                                                     pertinent information on, respond to, or
                                                      the substance will be used as a thin film                  Chemical name: Propaneperoxoic                      comment on this change.
                                                      for electronic device applications. Based               acid, 2,2-dimethyl-, 1,1,3,3-                             EPA response: EPA met with the PMN
                                                      on structure activity relationship (SAR)                tetramethylbutyl ester.                                submitter on December 17, 2014 to
                                                      analysis of test data on analogous                         CAS number: 22288–41–1.                             discuss procedural and policy issues
                                                      carbon nanotubes and other respirable                      Public comment: A notice of intent to               raised in connection with the
                                                      poorly soluble particulates, EPA                        adversely comment has been submitted.                  withdrawn SNURs. EPA awaits formal
                                                      identified potential lung effects,                         EPA response: EPA awaits the adverse                comment during the open comment
                                                      developmental toxicity, and dermal                      comment during the open comment                        period for this proposed rule.
                                                      toxicity from exposure to the PMN                       period for this notice of proposed                        Basis for action: The consolidated
                                                      substance via inhalation, dermal, and                   rulemaking.                                            PMN states that the substances will be
                                                      oral routes. Further, EPA predicts                         Basis for action: The PMN states that               used as surfactants for use in asphalt
                                                      toxicity to aquatic organisms via                       the use of the substance will be as a                  emulsions. Based on ecological SAR
                                                      releases of the PMN substance to surface                polymerization initiator for the                       analysis of test data on analogous
                                                      water. Although there is potential for                  production of polyvinyl chloride (PVC)                 aliphatic amines, EPA predicts toxicity
                                                      dermal exposure, EPA does not expect                    and polyethylene resin. Based on test                  to aquatic organisms may occur at
                                                      significant occupational exposures due                  data on the PMN substance, as well as                  concentrations that exceed the following
                                                      to the use of impervious gloves, and                    ecological SAR analysis of test data on                values of the PMN substances in surface
                                                      because the PMN is used in liquid form                  analogous peroxy esters, EPA predicts                  waters:
                                                      and is not spray applied. Further, EPA                  toxicity to aquatic organisms may occur
                                                      does not expect environmental releases                  at concentrations that exceed 3 parts per                           PMN No.                       Concentration
                                                      during the use identified in the PMN                    billion (ppb) of the PMN substance in                                                              of concern
                                                      submission. Therefore, EPA has not                      surface waters. As described in the                    P–14–89, P–14–92 ...............           110 ppb.
                                                      determined that the proposed                            PMN, releases of the substance are not                 P–14–90 ................................   240 ppb.
                                                      manufacturing, processing, or use of the                expected to result in surface water                    P–14–91 ................................   53 ppb.
                                                      substance may present an unreasonable                   concentrations that exceed 3 ppb.
                                                      risk human health or the environment.                   Therefore, EPA has not determined that                   For the use described in the PMNs,
                                                      EPA has determined, however, that any                   the proposed manufacturing,                            releases of the substances are not
                                                      use of the substance without the use of                 processing, or use of the substance may                expected to result in surface water
                                                      impervious gloves, where there is a                     present an unreasonable risk. EPA has                  concentrations that exceed these values.
                                                      potential for dermal exposure;                          determined, however, that any use of                   Therefore, EPA has not determined that
                                                      manufacturing the PMN substance for                     the substance resulting in surface waters              the proposed manufacturing,
                                                      use other than as a thin film for                       concentrations exceeding 3 ppb may                     processing, or use of the substance may
                                                      electronic device applications;                         result in significant adverse                          present an unreasonable risk. EPA has
                                                      manufacturing, processing, or using the                 environmental effects. Based on this                   determined, however, that any use of
                                                      PMN substance in a form other than a                    information, the PMN substance meets                   the substances resulting in surface water
                                                      liquid; use of the PMN substance                        the concern criteria at § 721.170 (b)(4)(i)            concentrations exceeding the
                                                      involving an application method that                    and (b)(4)(ii).                                        aforementioned concentrations of
                                                      generates a mist, vapor, or aerosol; or                    Recommended testing: EPA has                        concern may result in significant
                                                      any release of the PMN substance into                   determined that the results of a ready                 adverse environmental effects. Based on
                                                      surface waters may cause serious health                 biodegradability test (Organisation for                this information, the PMN substances
                                                      effects or significant adverse                          Economic Co-operation and                              meet the concern criteria at
                                                      environmental effects. Based on this                    Development (OECD) Test Guideline                      § 721.170(b)(4)(ii).
                                                      information, the PMN substance meets                    301C) with product-specific chemical                     Recommended testing: EPA has
                                                      the concern criteria in § 721.170                       analytics to validate the degradation                  determined that the results of a fish
                                                      (b)(3)(ii) and (b)(4)(ii).                              products (including intermediate                       acute toxicity test, freshwater and
                                                         Recommended testing: EPA has                         products) and the rates of degradation                 marine (OPPTS Test Guideline
                                                      determined that the results of an oral                  (including intermediate degradation                    850.1075); an aquatic invertebrate acute
                                                      and inhalation pharmacokinetic test                     rates); and a hydrolysis as a function of              toxicity test, freshwater daphnids
                                                      (OPPTS Test Guideline 870.7485); a 90-                  pH and temperature test (OPPTS Test                    (OPPTS Test Guideline 850.1010); and
                                                      day inhalation toxicity test (OPPTS Test                Guideline 835.2130) would help                         an algal toxicity test (OCSPP Test
                                                      Guideline 870.3465); a fish early-life                  characterize the environmental effects of              Guideline 850.4500) would help
                                                      stage toxicity test (OPPTS Test                         the PMN substance.                                     characterize the environmental effects of
                                                      Guideline 850.1400); a daphnid chronic                     CFR citation: 40 CFR 721.10780.                     the PMN substances. EPA also
                                                      toxicity test (OPPTS Test Guideline                                                                            recommends that the guidance
                                                      850.1300); an algal toxicity test (OCSPP                PMN Numbers P–14–89, P–14–90, P–14–
                                                                                                              91, and P–14–92                                        document on aquatic toxicity testing of
                                                      Test Guideline 850.4500); and a surface                                                                        difficult substances and mixtures (OECD
                                                      charge by electrophoresis by either the                    Chemical names: Fatty acid amide
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                                                                                                                                     Test Guideline 23) be followed.
                                                      (ASTM Test Guideline E2865–12) or                       hydrochlorides (generic).                                CFR citation: 40 CFR 721.10781.
                                                      measuring the zeta potential of                            CAS numbers: Claimed confidential.
                                                      nanoparticles (Nanotechnology                              Public comment: A notice of intent to               PMN Numbers P–14–158, P–14–159, P–
                                                      Characterization Library (NCL) Method                   adversely comment has been submitted,                  14–161, P–14–162, and P–14–163
                                                      PCC–2) (located in the Docket under                     by the PMN submitter. The comment                        Chemical names: Fatty acid amides
                                                      Docket ID number EPA–HQ–OPPT–                           expressed concern that EPA’s approach                  (generic).
                                                      2014–0390); would help characterize                     for these SNURs changed from that                        CAS numbers: Claimed confidential.
                                                      the human health and environmental                      transmitted in writing by EPA during                     Public comment: A notice of intent to
                                                      effects of the PMN substance.                           the PMN review period. As a result, the                adversely comment has been submitted,


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00015   Fmt 4702   Sfmt 4702   E:\FR\FM\10JNP1.SGM    10JNP1


                                                      32882                     Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules

                                                      by the PMN submitter. The comment                           toxicity test (OPPTS Test Guideline                       the substances resulting in surface water
                                                      expressed concern that EPA’s approach                       850.1400); a daphnid chronic toxicity                     concentrations exceeding the
                                                      for these SNURs changed from that                           test (OPPTS Test Guideline 850.1300);                     aforementioned concentrations of
                                                      transmitted in writing by EPA during                        and an algal toxicity test (OCSPP Test                    concern may result in significant
                                                      the PMN review period. As a result, the                     Guideline 850.4500) may be                                adverse environmental effects. Based on
                                                      PMN submitter was not given the                             recommended to help characterize the                      this information, the PMN substances
                                                      opportunity to discuss, provide                             environmental effects of the PMN                          meet the concern criteria at
                                                      pertinent information on, respond to, or                    substances.                                               § 721.170(b)(4)(ii).
                                                      comment on this change.                                       CFR citation: 40 CFR 721.10782.                           Recommended testing: EPA has
                                                         EPA response: EPA met with the PMN                                                                                 determined that the results of a fish
                                                                                                                  PMN Numbers P–14–173, P–14–175, P–
                                                      submitter on December 17, 2014 to                                                                                     acute toxicity test, freshwater and
                                                                                                                  14–176, P–14–177, P–14–178, P–14–179,
                                                      discuss procedural and policy issues                                                                                  marine (OPPTS Test Guideline
                                                                                                                  P–14–180, P–14–181, P–14–182, P–14–
                                                      raised in connection with the                                                                                         850.1075); an aquatic invertebrate acute
                                                                                                                  183, P–14–184, P–14–185, P–14–186, P–
                                                      withdrawn SNURs. EPA awaits formal                                                                                    toxicity test, freshwater daphnids
                                                                                                                  14–187, P–14–188, P–14–190, P–14–191,
                                                      comment during the open comment                                                                                       (OPPTS Test Guideline 850.1010); and
                                                                                                                  P–14–192, and P–14–193
                                                      period for this proposed rule.                                                                                        an algal toxicity test (OCSPP Test
                                                         Basis for action: The consolidated                          Chemical names: Fatty acid amide                       Guideline 850.4500) on P–14–184, and
                                                      PMN states that the substances will be                      acetates (generic).                                       any one of the remaining PMN
                                                      used as chemical intermediates and                             CAS numbers: Claimed confidential.                     substances, would help characterize the
                                                      additives for flotation products. Based                        Public comment: A notice of intent to                  environmental effects of the PMN
                                                      on ecological SAR analysis of test data                     adversely comment has been submitted,                     substances. Further, EPA determined
                                                      on analogous amides and aliphatic                           by the PMN submitter. The comment                         that the results of a fish acute toxicity
                                                      amines, EPA predicts toxicity to aquatic                    expressed concern that EPA’s approach                     mitigated by humic acid test (OPPTS
                                                      organisms may occur at concentrations                       for these SNURs changed from that                         Test Guideline 850.1085) on PMN
                                                      that exceed the following values of the                     transmitted in writing by EPA during                      P–14–184 would help characterize the
                                                      PMN substances in surface waters:                           the PMN review period. As a result, the                   environmental effects of the PMN
                                                                                                                  PMN submitter was not given the                           substance. EPA also recommends that
                                                                                                Concentration     opportunity to discuss, provide                           the guidance document on aquatic
                                                                   PMN No.                       of concern       pertinent information on, respond to, or                  toxicity testing of difficult substances
                                                                                                                  comment on this change.                                   and mixtures (OECD Test Guideline 23)
                                                      P–14–158, P–14–159, P–14–                 1 ppb.               EPA response: EPA met with the PMN
                                                        161, P–14–163.                                                                                                      be followed.
                                                                                                                  submitter on December 17, 2014 to                           CFR citation: 40 CFR 721.10783.
                                                      P–14–162 ..............................   140 ppb.
                                                                                                                  discuss procedural and policy issues
                                                                                                                  raised in connection with the                             V. Rationale and Objectives of the
                                                         For the use described in the PMNs,                                                                                 Proposed Rule
                                                      releases of the substances are not                          withdrawn SNURs. EPA awaits formal
                                                      expected to result in surface water                         comment during the open comment                           A. Rationale
                                                      concentrations that exceed these values.                    period for this proposed rule.
                                                                                                                     Basis for action: The PMNs state that                    During review of the PMNs submitted
                                                      Therefore, EPA has not determined that                                                                                for the chemical substances that are
                                                                                                                  the substances will be used as flotation
                                                      the proposed manufacturing,                                                                                           subject to these SNURs, EPA
                                                                                                                  additives for use in mineral processing.
                                                      processing, or use of the substance may                                                                               determined that one or more of the
                                                                                                                  Based on ecological SAR analysis of test
                                                      present an unreasonable risk. EPA has                                                                                 criteria of concern established at
                                                                                                                  data on analogous amides and aliphatic
                                                      determined, however, that any use of                                                                                  § 721.170 were met. For additional
                                                                                                                  amines, EPA predicts toxicity to aquatic
                                                      the substances resulting in surface water                                                                             discussion on these chemical
                                                                                                                  organisms may occur at concentrations
                                                      concentrations exceeding the                                                                                          substances, see Units II. and IV. of this
                                                                                                                  that exceed the following values of the
                                                      aforementioned concentrations of                                                                                      proposed rule.
                                                                                                                  PMN substances in surface waters:
                                                      concern may result in significant
                                                      adverse environmental effects. Based on                                                                               B. Objectives
                                                                                                                                                            Concentration
                                                      this information, the PMN substances                                     PMN No.                                         EPA is proposing these SNURs for
                                                                                                                                                             of concern
                                                      meet the concern criteria at                                                                                          specific chemical substances which
                                                      § 721.170(b)(4)(ii).                                        P–14–173, P–14–175, P–14–                 1 ppb.          have undergone premanufacture review
                                                         Recommended testing: EPA has                               178, P–14–179, P–14–181,                                because the Agency wants to achieve
                                                      determined that the results of (1) a water                    P–14–183, P–14–184, P–                                  the following objectives with regard to
                                                      solubility: Column elution method;                            14–192, P–14–193.                                       the significant new uses designated in
                                                                                                                  P–14–176, P–14–180, P–14–                 2 ppb.
                                                      shake flask method test (OPPTS Test                                                                                   this proposed rule:
                                                                                                                    185, P–14–186, P–14–187,
                                                      Guideline 830.7840) or a water                                P–14–190.                                                  • EPA would receive notice of any
                                                      solubility generator column method test                     P–14–177, P–14–188 ...........            3 ppb.          person’s intent to manufacture or
                                                      (OPPTS Test Guideline 830.7860); and                        P–14–191 ..............................   4 ppb.          process a listed chemical substance for
                                                      (2) a determination of the partition                        P–14–182 ..............................   140 ppb.        the described significant new use before
                                                      coefficient (n-octanol/water) by shake                                                                                that activity begins.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      flask method (OPPTS Test Guideline                            For the use described in the PMNs,                         • EPA would have an opportunity to
                                                      830.7550), or generator column method                       releases of the substances are not                        review and evaluate data submitted in a
                                                      (OPPTS Test Guideline 830.7560), or                         expected to result in surface water                       SNUN before the notice submitter
                                                      estimation by liquid chromatography                         concentrations that exceed these values.                  begins manufacturing or processing a
                                                      (OPPTS Test Guideline 830.7570) would                       Therefore, EPA has not determined that                    listed chemical substance for the
                                                      help characterize the physical/chemical                     the proposed manufacturing,                               described significant new use.
                                                      properties of the PMN substances.                           processing, or use of the substance may                      • EPA would be able to regulate
                                                      Depending upon the results of these                         present an unreasonable risk. EPA has                     prospective manufacturers or processors
                                                      data, the results of a fish early-life stage                determined, however, that any use of                      of a listed chemical substance before the


                                                 VerDate Sep<11>2014      16:20 Jun 09, 2015    Jkt 235001   PO 00000   Frm 00016    Fmt 4702     Sfmt 4702   E:\FR\FM\10JNP1.SGM   10JNP1


                                                                            Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules                                           32883

                                                      described significant new use of that                   discussion of the cutoff date for ongoing                • Potential benefits of the chemical
                                                      chemical substance occurs, provided                     uses.                                                  substances.
                                                      that regulation is warranted pursuant to                                                                         • Information on risks posed by the
                                                                                                              VII. Test Data and Other Information                   chemical substances compared to risks
                                                      TSCA sections 5(e), 5(f), 6, or 7.
                                                        Issuance of a SNUR for a chemical                        EPA recognizes that TSCA section 5                  posed by potential substitutes.
                                                      substance does not signify that the                     does not require developing any                        VIII. SNUN Submissions
                                                      chemical substance is listed on the                     particular test data before submission of
                                                      TSCA Chemical Substance Inventory                       a SNUN. The two exceptions are:                          According to § 721.1(c), persons
                                                      (TSCA Inventory). Guidance on how to                       1. Development of test data is                      submitting a SNUN must comply with
                                                      determine if a chemical substance is on                 required where the chemical substance                  the same notification requirements and
                                                      the TSCA Inventory is available on the                  subject to the SNUR is also subject to a               EPA regulatory procedures as persons
                                                      Internet at http://www.epa.gov/opptintr/                test rule under TSCA section 4 (see                    submitting a PMN, including
                                                      existingchemicals/pubs/tscainventory/                   TSCA section 5(b)(1)).                                 submission of test data on health and
                                                      index.html.                                                2. Development of test data may be                  environmental effects as described in 40
                                                                                                              necessary where the chemical substance                 CFR 720.50. SNUNs must be submitted
                                                      VI. Applicability of the Proposed Rule                                                                         on EPA Form No. 7710–25, generated
                                                      to Uses Occurring Before the Effective                  has been listed under TSCA section
                                                                                                              5(b)(4) (see TSCA section 5(b)(2)).                    using e-PMN software, and submitted to
                                                      Date of the Final Rule                                                                                         the Agency in accordance with the
                                                                                                                 In the absence of a TSCA section 4
                                                         To establish a significant new use,                                                                         procedures set forth in 40 CFR 720.40
                                                                                                              test rule or a TSCA section 5(b)(4)
                                                      EPA must determine that the use is not                                                                         and 721.25. E–PMN software is
                                                                                                              listing covering the chemical substance,
                                                      ongoing. The chemical substances                                                                               available electronically at http://
                                                                                                              persons are required only to submit test
                                                      subject to this proposed rule have                                                                             www.epa.gov/opptintr/newchems.
                                                                                                              data in their possession or control and
                                                      undergone premanufacture review. In
                                                                                                              to describe any other data known to or                 IX. Economic Analysis
                                                      cases where EPA has not received a
                                                      notice of commencement (NOC) and the                    reasonably ascertainable by them (see 40                 EPA has evaluated the potential costs
                                                      chemical substance has not been added                   CFR 720.50). However, upon review of                   of establishing SNUN requirements for
                                                      to the TSCA Inventory, no person may                    PMNs and SNUNs, the Agency has the                     potential manufacturers and processors
                                                      commence such activities without first                  authority to require appropriate testing.              of the chemical substances subject to
                                                      submitting a PMN. Therefore, for                        Descriptions of tests are provided for                 this proposed rule, during the
                                                      chemical substances for which an NOC                    informational purposes. EPA strongly                   development of the direct final rule.
                                                      has not been submitted EPA concludes                    encourages persons, before performing                  EPA’s complete economic analysis is
                                                      that the designated significant new uses                any testing, to consult with the Agency                available in the docket under docket ID
                                                      are not ongoing.                                        pertaining to protocol selection. To                   number EPA–HQ–OPPT–2014–0390.
                                                         When chemical substances identified                  access the OCSPP test guidelines
                                                                                                              referenced in this document                            X. Statutory and Executive Order
                                                      in this proposed rule are added to the                                                                         Reviews
                                                      TSCA Inventory, EPA recognizes that,                    electronically, please go to http://
                                                      before the rule is effective, other persons             www.epa.gov/ocspp and select ‘‘Test                    A. Executive Order 12866
                                                      might engage in a use that has been                     Methods and Guidelines.’’ The
                                                                                                                                                                       This proposed rule would establish
                                                      identified as a significant new use. The                Organisation for Economic Co-operation                 SNURs for 30 chemical substances that
                                                      identities of 29 of the 30 chemical                     and Development (OECD) test                            were the subject of PMNs. The Office of
                                                      substances subject to this proposed rule                guidelines are available from the OECD                 Management and Budget (OMB) has
                                                      have been claimed as confidential and                   Bookshop at http://                                    exempted these types of actions from
                                                      EPA has received no post-PMN bona                       www.oecdbookshop.org or SourceOECD                     review under Executive Order 12866,
                                                      fide submissions (per §§ 720.25 and                     at http://www.sourceoecd.org. ASTM                     entitled ‘‘Regulatory Planning and
                                                      721.11). Based on this, the Agency                      International standards are available at               Review’’ (58 FR 51735, October 4, 1993).
                                                      believes that it is highly unlikely that                http://www.astm.org/Standard/
                                                      any of the significant new uses                         index.shtml.                                           B. Paperwork Reduction Act (PRA)
                                                      described in the regulatory text of this                   The recommended tests specified in                    According to PRA (44 U.S.C. 3501 et
                                                      proposed rule are ongoing.                              Unit IV. may not be the only means of                  seq.), an agency may not conduct or
                                                         Therefore, EPA designates June 10,                   addressing the potential risks of the                  sponsor, and a person is not required to
                                                      2015 as the cutoff date for determining                 chemical substance. However,                           respond to a collection of information
                                                      whether the new use is ongoing. Persons                 submitting a SNUN without any test                     that requires OMB approval under PRA,
                                                      who begin commercial manufacture or                     data may increase the likelihood that                  unless it has been approved by OMB
                                                      processing of the chemical substances                   EPA will take action under TSCA                        and displays a currently valid OMB
                                                      for a significant new use identified as of              section 5(e), particularly if satisfactory             control number. The OMB control
                                                      that date would have to cease any such                  test results have not been obtained from               numbers for EPA’s regulations in title 40
                                                      activity upon the effective date of the                 a prior PMN or SNUN submitter. EPA                     of the CFR, after appearing in the
                                                      final rule. To resume their activities,                 recommends that potential SNUN                         Federal Register, are listed in 40 CFR
                                                      these persons would have to first                       submitters contact EPA early enough so                 part 9, and included on the related
                                                      comply with all applicable SNUR                         that they will be able to conduct the                  collection instrument or form, if
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      notification requirements and wait until                appropriate tests.                                     applicable.
                                                      the notice review period, including any                    SNUN submitters should be aware                       The information collection
                                                      extensions, expires. If such a person met               that EPA will be better able to evaluate               requirements related to this proposed
                                                      the conditions of advance compliance                    SNUNs which provide detailed                           rule have already been approved by
                                                      under § 721.45(h), the person would be                  information on the following:                          OMB pursuant to PRA under OMB
                                                      considered exempt from the                                 • Human exposure and                                control number 2070–0012 (EPA ICR
                                                      requirements of the SNUR. Consult the                   environmental release that may result                  No. 574). This proposed rule would not
                                                      Federal Register document of April 24,                  from the significant new use of the                    impose any burden requiring additional
                                                      1990 (55 FR 17376) for a more detailed                  chemical substances.                                   OMB approval. If an entity were to


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00017   Fmt 4702   Sfmt 4702   E:\FR\FM\10JNP1.SGM   10JNP1


                                                      32884                 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules

                                                      submit a SNUN to the Agency, the                        determined that this proposed rule                     J. Executive Order 12898
                                                      annual burden is estimated to average                   would not impose any enforceable duty,
                                                                                                                                                                        This proposed rule does not entail
                                                      between 30 and 170 hours per response.                  contain any unfunded mandate, or
                                                                                                                                                                     special considerations of environmental
                                                      This burden estimate includes the time                  otherwise have any effect on small
                                                                                                                                                                     justice related issues as delineated by
                                                      needed to review instructions, search                   governments subject to the requirements
                                                                                                                                                                     Executive Order 12898, entitled
                                                      existing data sources, gather and                       of UMRA sections 202, 203, 204, or 205
                                                                                                                                                                     ‘‘Federal Actions to Address
                                                      maintain the data needed, and                           (2 U.S.C. 1501 et seq.).
                                                                                                                                                                     Environmental Justice in Minority
                                                      complete, review, and submit the
                                                                                                              E. Executive Order 13132                               Populations and Low-Income
                                                      required SNUN.
                                                        Send any comments about the                              This proposed rule would not have a                 Populations’’ (59 FR 7629, February 16,
                                                      accuracy of the burden estimate, and                    substantial direct effect on States, on the            1994).
                                                      any suggested methods for minimizing                    relationship between the national                      List of Subjects in 40 CFR Part 721
                                                      respondent burden, including through                    government and the States, or on the
                                                      the use of automated collection                         distribution of power and                                Environmental protection, Chemicals,
                                                      techniques, to the Director, Collection                 responsibilities among the various                     Hazardous substances, Reporting and
                                                      Strategies Division, Office of                          levels of government, as specified in                  recordkeeping requirements.
                                                      Environmental Information (2822T),                      Executive Order 13132, entitled                           Dated: June 1, 2015.
                                                      Environmental Protection Agency, 1200                   ‘‘Federalism’’ (64 FR 43255, August 10,                Maria J. Doa,
                                                      Pennsylvania Ave. NW., Washington,                      1999).                                                 Director, Chemical Control Division, Office
                                                      DC 20460–0001. Please remember to                       F. Executive Order 13175                               of Pollution Prevention and Toxics.
                                                      include the OMB control number in any
                                                                                                                 This proposed rule would not have                     Therefore, it is proposed that 40 CFR
                                                      correspondence, but do not submit any
                                                                                                              Tribal implications because it is not                  chapter I be amended as follows:
                                                      completed forms to this address.
                                                                                                              expected to have substantial direct
                                                      C. Regulatory Flexibility Act (RFA)                     effects on Indian Tribes. This proposed                PART 721—[AMENDED]
                                                        On February 18, 2012, EPA certified                   rule would not significantly nor
                                                                                                                                                                     ■ 1. The authority citation for part 721
                                                      pursuant to RFA section 605(b) (5 U.S.C.                uniquely affect the communities of
                                                                                                                                                                     continues to read as follows:
                                                      601 et seq.), that promulgation of a                    Indian Tribal governments, nor would it
                                                      SNUR does not have a significant                        involve or impose any requirements that                  Authority: 15 U.S.C. 2604, 2607, and
                                                      economic impact on a substantial                        affect Indian Tribes. Accordingly, the                 2625(c).
                                                      number of small entities where the                      requirements of Executive Order 13175,                 ■ 2. Add § 721.10776 to subpart E to
                                                      following are true:                                     entitled ‘‘Consultation and Coordination               read as follows:
                                                        1. A significant number of SNUNs                      with Indian Tribal Governments’’ (65 FR
                                                      would not be submitted by small                         67249, November 9, 2000), do not apply                 § 721.10776 Functionalized carbon
                                                      entities in response to the SNUR.                       to this proposed rule.                                 nanotubes (generic).
                                                        2. The SNUR submitted by any small                                                                              (a) Chemical substance and
                                                                                                              G. Executive Order 13045
                                                      entity would not cost significantly more                                                                       significant new uses subject to reporting.
                                                      than $8,300.                                               This proposed rule is not subject to                (1) The chemical substance identified
                                                        A copy of that certification is                       Executive Order 13045, entitled                        generically as functionalized carbon
                                                      available in the docket for this proposed               ‘‘Protection of Children from                          nanotubes (PMN P–13–793) is subject to
                                                      rule.                                                   Environmental Health Risks and Safety                  reporting under this section for the
                                                        This proposed rule is within the                      Risks’’ (62 FR 19885, April 23, 1997),                 significant new uses described in
                                                      scope of the February 18, 2012                          because this is not an economically                    paragraph (a)(2) of this section. The
                                                      certification. Based on the Economic                    significant regulatory action as defined               requirements of this section do not
                                                      Analysis discussed in Unit IX. and                      by Executive Order 12866, and this                     apply to quantities of the PMN
                                                      EPA’s experience promulgating SNURs                     proposed rule does not address                         substance after they have been
                                                      (discussed in the certification), EPA                   environmental health or safety risks                   completely reacted (cured).
                                                      believes that the following are true:                   disproportionately affecting children.                    (2) The significant new uses are:
                                                        • A significant number of SNUNs
                                                                                                              H. Executive Order 13211                                  (i) Protection in the workplace.
                                                      would not be submitted by small
                                                      entities in response to the SNUR.                          This proposed rule is not subject to                Requirements as specified in § 721.63
                                                        • Submission of the SNUN would not                    Executive Order 13211, entitled                        (a)(1), (a)(2)(i), and (a)(3). When
                                                      cost any small entity significantly more                ‘‘Actions Concerning Regulations That                  determining which persons are
                                                      than $8,300.                                            Significantly Affect Energy Supply,                    reasonably likely to be exposed as
                                                        Therefore, the promulgation of the                    Distribution, or Use’’ (66 FR 28355, May               required for § 721.63 (a)(1), engineering
                                                      SNUR would not have a significant                       22, 2001), because this proposed rule is               control measures (e.g., enclosure or
                                                      economic impact on a substantial                        not expected to affect energy supply,                  confinement of the operation, general
                                                      number of small entities.                               distribution, or use and because this                  and local ventilation) or administrative
                                                                                                              proposed rule is not a significant                     control measures (e.g., workplace
                                                      D. Unfunded Mandates Reform Act                                                                                policies and procedures) shall be
                                                                                                              regulatory action under Executive Order
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      (UMRA)                                                                                                         considered and implemented to prevent
                                                                                                              12866.
                                                        Based on EPA’s experience with                                                                               exposure, where feasible.
                                                      proposing and finalizing SNURs, State,                  I. National Technology Transfer and                       (ii) Industrial, commercial, and
                                                      local, and Tribal governments have not                  Advancement Act (NTTAA)                                consumer activities. Requirements as
                                                      been impacted by these rulemakings,                        In addition, since this proposed rule               specified in § 721.80(j) (a significant
                                                      and EPA does not have any reasons to                    would not involve any technical                        new use is use other than as a thin film
                                                      believe that any State, local, or Tribal                standards, NTTAA section 12(d) (15                     for electronic device applications),
                                                      government would be impacted by this                    U.S.C. 272 note), would not apply to                   (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), (x)(2),
                                                      proposed rule. As such, EPA has                         this proposed rule.                                    and (y)(1).


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00018   Fmt 4702   Sfmt 4702   E:\FR\FM\10JNP1.SGM   10JNP1


                                                                            Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Proposed Rules                                                         32885

                                                         (iii) Release to water. Requirements as                (b) Specific requirements. The                                                                 Concentration
                                                                                                                                                                                  PMN No.
                                                      specified in § 721.90(a)(1), (b)(1), and                provisions of subpart A of this part                                                              of concern
                                                      (c)(1).                                                 apply to this section except as modified
                                                         (b) Specific requirements. The                       by this paragraph.                                     P–14–173, P–14–175, P–14–                 1 ppb.
                                                      provisions of subpart A of this part                      (1) Recordkeeping. Recordkeeping                       178, P–14–179, P–14–181,
                                                                                                                                                                       P–14–183, P–14–184, P–
                                                      apply to this section except as modified                requirements as specified in
                                                                                                                                                                       14–192, P–14–193.
                                                      by this paragraph.                                      § 721.125(a), (b), (c), and (k) are                    P–14–176, P–14–180, P–14–                 2 ppb.
                                                         (1) Recordkeeping. Recordkeeping                     applicable to manufacturers and                          185, P–14–186, P–14–187,
                                                      requirements as specified in                            processors of these substances.                          P–14–190.
                                                      § 721.125(a) through (e), (i), and (k) are                (2) Limitations or revocation of                     P–14–177, P–14–188 ...........            3 ppb.
                                                      applicable to manufacturers and                         certain notification requirements. The                 P–14–191 ..............................   4 ppb.
                                                      processors of this substance.                           provisions of § 721.185 apply to this                  P–14–182 ..............................   140 ppb.
                                                         (2) Limitations or revocation of                     section.
                                                      certain notification requirements. The                  ■ 5. Add § 721.10782 to subpart E to                     (ii) [Reserved]
                                                      provisions of § 721.185 apply to this                   read as follows:                                         (b) Specific requirements. The
                                                      section.                                                                                                       provisions of subpart A of this part
                                                                                                              § 721.10782       Fatty acid amides (generic).         apply to this section except as modified
                                                      ■ 3. Add § 721.10780 to subpart E to
                                                      read as follows:                                           (a) Chemical substance and                          by this paragraph.
                                                                                                              significant new uses subject to reporting.               (1) Recordkeeping. Recordkeeping
                                                      § 721.10780 Propaneperoxoic acid, 2,2-                  (1) The chemical substance identified                  requirements as specified in
                                                      dimethyl-, 1,1,3,3-tetramethylbutyl ester.              generically as fatty acid amides (PMN                  § 721.125(a), (b), (c), and (k) are
                                                         (a) Chemical substance and                           P–14–158, P–14–159, P–14–161, P–14–                    applicable to manufacturers and
                                                      significant new uses subject to reporting.              162, and P–14–163) are subject to                      processors of these substances.
                                                      (1) The chemical substance identified as                reporting under this section for the                     (2) Limitations or revocation of
                                                      propaneperoxoic acid, 2,2-dimethyl-,                    significant new uses described in                      certain notification requirements. The
                                                      1,1,3,3-tetramethylbutyl ester (PMN P–                  paragraph (a)(2) of this section.                      provisions of § 721.185 apply to this
                                                      14–72; CAS No. 22288–41–1) is subject                      (2) The significant new uses are:                   section.
                                                      to reporting under this section for the                    (i) Release to water. Requirements as               [FR Doc. 2015–13941 Filed 6–9–15; 8:45 am]
                                                      significant new uses described in                       specified in § 721.90(a)(4), (b)(4), and               BILLING CODE 6560–50–P
                                                      paragraph (a)(2) of this section.                       (c)(4) (where N = 1 for PMNs P–14–158,
                                                         (2) The significant new uses are:                    P–14–159, P–14–161, and P–14–163; N
                                                         (i) Release to water. Requirements as                = 140 for PMN P–14–162).                               FEDERAL COMMUNICATIONS
                                                      specified in § 721.90(a)(4), (b)(4), and                   (ii) [Reserved]                                     COMMISSION
                                                      (c)(4) (N=3).                                              (b) Specific requirements. The
                                                         (ii) [Reserved]                                      provisions of subpart A of this part                   47 CFR Part 64
                                                         (b) Specific requirements. The                       apply to this section except as modified
                                                      provisions of subpart A of this part                    by this paragraph.                                     [CG Docket No. 10–210; FCC 15–58]
                                                      apply to this section except as modified                   (1) Recordkeeping. Recordkeeping
                                                      by this paragraph.                                      requirements as specified in                           Relay Services for Deaf-Blind
                                                         (1) Recordkeeping. Recordkeeping                     § 721.125(a), (b), (c), and (k) are                    Individuals
                                                      requirements as specified in                            applicable to manufacturers and                        AGENCY:  Federal Communications
                                                      § 721.125(a), (b), (c), and (k) are                     processors of these substances.                        Commission.
                                                      applicable to manufacturers and                            (2) Limitations or revocation of
                                                                                                                                                                     ACTION: Proposed rule.
                                                      processors of this substance.                           certain notification requirements. The
                                                         (2) Limitations or revocation of                     provisions of § 721.185 apply to this                  SUMMARY:    In this document, the
                                                      certain notification requirements. The                  section.                                               Commission proposes to amend its rules
                                                      provisions of § 721.185 apply to this                   ■ 6. Add § 721.10783 to subpart E to                   to continue the National Deaf-Blind
                                                      section.                                                read as follows:                                       Equipment Distribution Program
                                                      ■ 4. Add § 721.10781 to subpart E to                                                                           (NDBEDP) on a permanent basis. The
                                                      read as follows:                                        § 721.10783       Fatty acid amide acetates
                                                                                                              (generic).                                             NDBEDP is currently a pilot program
                                                      § 721.10781 Fatty acid amide                                                                                   that supports the distribution of
                                                                                                                 (a) Chemical substance and
                                                      hydrochlorides (generic).                                                                                      communications devices to low-income
                                                                                                              significant new uses subject to reporting.
                                                                                                                                                                     individuals who are deaf-blind.
                                                         (a) Chemical substance and                           (1) The chemical substance identified
                                                      significant new uses subject to reporting.              generically as fatty acid amide acetates               DATES: Comments are due July 27, 2015
                                                      (1) The chemical substance identified                   (PMNs P–14–173, P–14–175, P–14–176,                    and reply comments are due August 10,
                                                      generically as fatty acid amide                         P–14–177, P–14–178, P–14–179, P–14–                    2015.
                                                      hydrochlorides (PMNs P–14–89, P–14–                     180, P–14–181, P–14–182, P–14–183, P–                  ADDRESSES: You may submit comments,
                                                      90, P–14–91 and P–14–92) are subject to                 14–184, P–14–185, P–14–186, P–14–                      identified by CG Docket No. 10–210, by
                                                      reporting under this section for the                    187, P–14–188, P–14–190, P–14–191, P–                  any of the following methods:
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      significant new uses described in                       14–192 and P–14–193) are subject to                       • Electronic Filers: Comments may be
                                                      paragraph (a)(2) of this section.                       reporting under this section for the                   filed electronically using the Internet by
                                                         (2) The significant new uses are:                    significant new uses described in                      accessing the Commission’s Electronic
                                                         (i) Release to water. Requirements as                paragraph (a)(2) of this section.                      Comment Filing System (ECFS), through
                                                      specified in § 721.90(a)(4), (b)(4), and                   (2) The significant new uses are:                   the Commission’s Web site http://
                                                      (c)(4) (where N = 110 for PMNs P–14–                       (i) Release to water. Requirements as               fjallfoss.fcc.gov/ecfs2/. Filers should
                                                      89 and P–14–92; N = 240 for PMN P–                      specified in § 721.90(a)(4), (b)(4), and               follow the instructions provided on the
                                                      14–90; N = 53 for PMN P–14–91).                         (c)(4) (where N = concentration of                     Web site for submitting comments. For
                                                         (ii) [Reserved]                                      concern as follows):                                   ECFS filers, in completing the


                                                 VerDate Sep<11>2014   16:20 Jun 09, 2015   Jkt 235001   PO 00000   Frm 00019   Fmt 4702   Sfmt 4702   E:\FR\FM\10JNP1.SGM   10JNP1



Document Created: 2015-12-15 15:17:41
Document Modified: 2015-12-15 15:17:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesComments must be received on or before July 10, 2015.
ContactFor 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 Citation80 FR 32879 
RIN Number2070-AB27
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR