Document ID: EPA-HQ-OPPT-2015-0810-0238
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rule on Certain Chemical Substances
Posted Date: 2016-10-27T04:00Z

[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)]
[Proposed Rules]
[Pages 74755-74761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25933]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2015-0810; FRL-9951-77]
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 three chemical substances which 
were the subject of premanufacture notices (PMNs). The applicable 
review periods for the PMNs submitted for these chemical substances all 
ended prior to June 22, 2016, the date on which President Obama signed 
into law the Frank R. Lautenberg Chemical Safety for the 21st Century 
Act which amends TSCA). This action would require persons who intend to 
manufacture (defined by statute to include import) or process any of 
the chemical substances for an activity that is designated as a 
significant new use by this proposed rule to notify EPA at least 90 
days before commencing that activity. The required notification 
initiates EPA's evaluation of the intended use within the applicable 
review period. Manufacture and processing for the significant new use 
is unable to commence until EPA has conducted a review of the notice, 
made an appropriate determination on the notice, and take such actions 
as are required with that determination.

DATES: Comments must be received on or before November 28, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0810, 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: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
    Manufacturers (including importers) or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification

[[Page 74756]]

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 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 three 
chemical substances which were the subject of PMNs P-15-276, P-15-378, 
and P-15-559. 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 May 
16, 2016 (81 FR 30452) (FRL-9944-77) 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 July 14, 2016 (81 FR 45416) (FRL-9948-
81), and is now issuing this proposed rule on these three chemical 
substances. The records for the direct final SNURs on these chemical 
substances were established as docket EPA-HQ-OPPT-2015-0810. Those 
records include information considered by the Agency in developing the 
direct final rule. While notices of intent to submit adverse comments 
were received during the direct final rule phase, no substantive 
comments were submitted. EPA awaits the adverse comments during the 
open comment period for this proposed rule. Comments received on the 
two isocyanate PMN chemicals in today's proposed rule will be addressed 
in a final rule with isocyanate PMN chemicals that were the subject of 
previous proposed rules published in the Federal Register at 80 FR 845 
(January 7, 2015) and 81 FR 21830 (April 13, 2016).

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore 
prohibits such manufacturing or processing from commencing until EPA 
has conducted a review of the notice, made an appropriate determination 
on the notice, and taken such actions as are required in association 
with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in 
Unit V., the general SNUR provisions are found at 40 CFR part 721, 
subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to Sec.  721.1(c), persons subject to these SNURs must comply 
with the same SNUN requirements and EPA regulatory procedures as 
submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA must either determine that the 
significant new use is not likely to present an unreasonable risk of 
injury or take such regulatory action as is associated with an 
alternative determination before the manufacture or processing for the 
significant new use can commence. If EPA determines that the 
significant new use is not likely to present an unreasonable risk, EPA 
is required under TSCA section 5(g) to make public, and submit for 
publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

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

IV. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for three chemical substances in 40 CFR part 721, subpart E. In this 
unit, EPA

[[Page 74757]]

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 
three direct final SNURs
     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 volume) 
and other uses designated in this proposed rule, may be claimed as CBI.

    The three PMN substances included in this rulemaking are not 
subject to consent orders under TSCA section 5(e). These cases 
completed Agency review prior to June 22, 2016. Under TSCA, prior to 
the enactment of the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act on June 22, 2016, EPA did not find that the use scenario 
described in the PMN triggered the determinations set forth under TSCA 
section 5(e). However, EPA does believe that certain changes from the 
use scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
TSCA section 5(e) SNURs'' are consistent with the determination made at 
the time and are promulgated pursuant to Sec.  [emsp14]721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-TSCA section 5(e) SNURs issued under Sec.  [emsp14]721.170 
satisfies the two requirements stipulated in Sec.  721.170(c)(2), i.e., 
these significant new use activities, ``(i) are different from those 
described in the premanufacture notice for the substance, including any 
amendments, deletions, and additions of activities to the 
premanufacture notice, and (ii) may be accompanied by changes in 
exposure or release levels that are significant in relation to the 
health or environmental concerns identified'' for the PMN substance.

PMN Number P-15-276

    Chemical name: Functionalized carbon nanotubes (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a thin film for electronic device applications. Based on SAR analysis 
of test data on analogous carbon nanotubes and other respirable poorly 
soluble particulates, EPA identified potential lung effects and skin 
penetration and toxicity induction from inhalation and dermal exposure 
to the PMN substance. 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 a liquid and is not spray applied except in a closed 
system. 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, and or use of the 
substance may present an unreasonable risk to human health or the 
environment. EPA has determined, however, that any use of the substance 
without the use of impervious gloves, where there is 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 except in a closed system; or any release of 
the PMN substance into surface waters or disposal other than by 
landfill or incineration may cause serious health effects or 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that 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); an algal 
toxicity test (OCSPP Test Guideline 850.4500); a 90-day inhalation 
toxicity test (OPPTS 870.3465) with additional testing parameters 
beyond those noted at CFR 870.3465, for using the 90-day subchronic 
protocol for nanomaterial assessment; a two-year inhalation bioassay 
(OPPTS Test Guideline 870.4200); and a surface charge by 
electrophoresis (for example, using ASTM E2865-12 or NCL Method PCC-2--
Measuring the Zeta Potential of Nanoparticles) would help characterize 
the health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10902.

PMN Number P-15-378

    Chemical name: Diisocyanato hexane, homopolymer, alkanoic acid-
polyalkylene glycol ether with substituted alkane (3:1) reaction 
products-blocked (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the substance will be used as 
a dual cure/UV cure adhesion/barrier coating for wood substrates. Based 
on SAR analysis of test data on analogous diisocyanates, EPA identified 
concerns for respiratory sensitization. Furthermore, the National 
Institute for Occupational Safety and Health (NIOSH) alert at http://www.cdc.gov/niosh/docs/2006-149/pdfs/2006-149.pdf summarizes four case 
reports: one death and several incidents of asthma or other respiratory 
disease following exposure to methylenebis(phenyl isocyanate) (MDI) 
during spray-on truck bed lining operations. For this PMN substance, a 
significant new use is any use of the substance without a NIOSH-
certified particulate respirator with an APF of at least 10 where there 
is a potential for inhalation exposure, or any use in consumer 
products. For new isocyanates submitted as PMNs, EPA expects to issue 
TSCA section 5(e) orders imposing 0.1% limits on total residual 
isocyanates and greater levels of respiratory protection (at least an 
APF of 50, or 1000 if used in a process that generates a vapor or 
particulate), and no consumer use. The Agency would then likely issue a 
SNUR defining the significant new use as total residual isocyanates 
exceeding that 0.1% limit and any use in a consumer product. However, 
as mentioned in Unit VI., below, and in the original May 16, 2016 
direct final rule, EPA designated that date as the cutoff date for 
determining whether the new use is ongoing. Furthermore, a Notice of 
Commencement of Manufacture or Import was submitted and the chemical 
substance is now on the TSCA Inventory and is being used with 
respiratory protection with an APF of less than 50. For these reasons, 
EPA is not changing the terms of the original direct final SNUR for 
this PMN substance. Based on this information, the PMN substance meets 
the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the

[[Page 74758]]

human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10913.

PMN Number P-15-559

    Chemical name: Modified diphenylmethane diisocyanate prepolymer 
with polyol (generic).
    CAS number: Claimed confidential.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material for 
flexible foam. Based on SAR analysis of analogous diisocyanates, EPA 
identified concerns for potential dermal and respiratory sensitization 
from dermal and inhalation exposures, and for pulmonary toxicity from 
inhalation exposure, to the PMN substance where the average molecular 
weight is below 7,500 daltons and any molecular weight species is below 
1,000 daltons. For the molecular weight distribution described in the 
PMN, significant occupational exposures are not expected. Therefore, 
EPA has not determined that the proposed manufacture of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
manufacture of the PMN substance with an average molecular weight below 
7,500 daltons, and where any molecular weight species is below 1,000 
daltons may cause serious health effects. For new isocyanates submitted 
as PMNs, EPA expects to issue TSCA section 5(e) orders imposing 0.1% 
limits on total residual isocyanates and greater levels of respiratory 
protection (at least an APF of 50, or 1000 if used in a process that 
generates a vapor or particulate), and no consumer use. The Agency 
would then likely issue a SNUR defining the significant new use as 
total residual isocyanates exceeding that 0.1% limit and any use in a 
consumer product. However, as mentioned in Unit VI., below, and in the 
original May 16, 2016 direct final rule, EPA designated that date as 
the cutoff date for determining whether the new use is ongoing. 
Furthermore, a Notice of Commencement of Manufacture or Import was 
submitted and the chemical substance is now on the TSCA Inventory and 
is being used with respiratory protection with an APF of less than 50. 
For these reasons, EPA is not changing the terms of the original direct 
final SNUR for this PMN substance. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10920.

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.  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 either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
https://www.epa.gov/tsca-inventory.

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

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. The identities of the three 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, as mentioned in the original May 16, 2016 direct final 
rule, EPA designated that date 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 May 16, 2016 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. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Descriptions of tests are provided for

[[Page 74759]]

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 Guidelines for Pesticides and Toxic Substances.''
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN 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 and define the terms of any potentially necessary 
controls if the submitter provides detailed information on the 
following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.

VIII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/how-submit-e-pmn.

IX. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the risk assessment documents included in the public docket. These 
information sources supply information relevant to whether a particular 
use would be a significant new use, based on relevant factors including 
those listed under TSCA section 5(a)(2).
    The clarity and completeness of the data, assumptions, methods, 
quality assurance, and analyses employed in EPA's decision are 
documented, as applicable and to the extent necessary for purposes of 
this proposed significant new use rule, in Unit II and in the documents 
noted above. EPA recognizes, based on the available information, that 
there is variability and uncertainty in whether any particular 
significant new use would actually present an unreasonable risk. For 
precisely this reason, it is appropriate to secure a future notice and 
review process for these uses, at such time as they are known more 
definitely. The extent to which the various information, procedures, 
measures, methods, protocols, methodologies or models used in EPA's 
decision have been subject to independent verification or peer review 
is adequate to justify their use, collectively, in the record for a 
significant new use rule.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule, during the development of the 
direct final rule. EPA's complete economic analysis is available in the 
docket under docket ID number EPA-HQ-OPPT-2015-0810.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

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

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This proposed rule would 
not impose any burden requiring additional OMB approval. If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
average between 30 and 170 hours per response. This burden estimate 
includes the time needed to review instructions, search existing data 
sources, gather and maintain the data needed, and complete, review, and 
submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to

[[Page 74760]]

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: October 19, 2016.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

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

PART 721--[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.  721.10902 to subpart E to read as follows:

Sec.  721.10902  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-15-276) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this rule do not apply to 
quantities of the PMN substance after it has 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. A significant new use is manufacture, 
process, or use of the PMN substance other than in a liquid 
formulation. A significant new use is use other than as a thin film for 
electronic device applications or any use involving an application 
method that generates a vapor, mist, or aerosol unless such application 
method occurs in an enclosed process. An enclosed process is defined as 
an operation that is designed and operated so that there is no release 
associated with normal or routine production processes into the 
environment of any substance present in the operation. An operation 
with inadvertent or emergency pressure relief releases remains an 
enclosed process so long as measures are taken to prevent worker 
exposure to and environmental contamination from the releases.
    (iii) Disposal. Requirements as specified in Sec.  721.85 (a)(1), 
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2).
    (iv) 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), (j), 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.  721.10913 to subpart E to read as follows:

Sec.  721.10913  Diisocyanato hexane, homopolymer, alkanoic acid-
polyalkylene glycol ether with substituted alkane (3:1) reaction 
products-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diisocyanato hexane, homopolymer, alkanoic acid-polyalkylene glycol 
ether with substituted alkane (3:1) reaction products-blocked (PMN P-
15-378) 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) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(4), (a)(6)(ii), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63(a)(4), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible. The following 
National Institute for Occupational

[[Page 74761]]

Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified power air-purifying respirator with a hood or 
helmet and with appropriate gas/vapor (acid gas, organic vapor, or 
substance specific) cartridges in combination with HEPA filters.
    (B) NIOSH-certified continuous flow supplied-air respirator 
equipped with a loose fitting facepiece, hood, or helmet.
    (C) NIOSH-certified negative pressure (demand) supplied-air 
respirator with a full facepiece.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) 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.  721.10920 to subpart E to read as follows:

Sec.  721.10920  Modified diphenylmethane diisocyanate prepolymer with 
polyol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
modified diphenylmethane diisocyanate perpolymer with polyol (PMN P-15-
559) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use of the substance is 
manufacture of the substance where the average molecular weight is 
below 7,500 daltons, and where any molecular weight species is below 
1,000 daltons.
    (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 (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2016-25933 Filed 10-26-16; 8:45 am]
 BILLING CODE 6560-50-P