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

ENVIRONMENTAL PROTECTION AGENCY

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

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, Number 111 (Wednesday, June 10, 2015)]
[Proposed Rules]
[Pages 32879-32885]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13941]


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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.

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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