81_FR_74963 81 FR 74755 - Significant New Use Rule on Certain Chemical Substances

81 FR 74755 - Significant New Use Rule on Certain Chemical Substances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 208 (October 27, 2016)

Page Range74755-74761
FR Document2016-25933

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.

Federal Register, Volume 81 Issue 208 (Thursday, October 27, 2016)
[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)]
[Proposed Rules]
[Pages 74755-74761]
From the Federal Register Online  [www.thefederalregister.org]
[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: [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

[[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



                                                                        Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules                                         74755

                                                     2. Tips for preparing your comments.                 obtained through the petition summary                 ADDRESSES:   Submit your comments,
                                                  When preparing and submitting your                      referenced in this unit.                              identified by docket identification (ID)
                                                  comments, see the commenting tips at                      PP 4F8303. EPA–HQ–OPP–2016–                         number EPA–HQ–OPPT–2015–0810, by
                                                  http://www.epa.gov/dockets/                             0594. Dow AgroSciences, 9330                          one of the following methods:
                                                  comments.html.                                          Zionsville Road, Indianapolis, IN 46268,                • Federal eRulemaking Portal: http://
                                                     3. Environmental justice. EPA seeks to               requests to establish a tolerance in 40               www.regulations.gov. Follow the online
                                                  achieve environmental justice, the fair                 CFR part 180 for residues of the                      instructions for submitting comments.
                                                  treatment and meaningful involvement                    herbicide 2,4–D in or on cotton, gin                  Do not submit electronically any
                                                  of any group, including minority and/or                 byproducts at 1.5 parts per million                   information you consider to be
                                                  low-income populations, in the                          (ppm), and cotton, undelinted seed at                 Confidential Business Information (CBI)
                                                  development, implementation, and                        0.8 ppm. The EN–CAS Method No.                        or other information whose disclosure is
                                                  enforcement of environmental laws,                      ENC–2/93 is used to measure and                       restricted by statute.
                                                  regulations, and policies. To help                      evaluate the chemical 2,4–D. Contact:                   • Mail: Document Control Office
                                                  address potential environmental justice                 RD.                                                   (7407M), Office of Pollution Prevention
                                                  issues, the Agency seeks information on                   Authority: 21 U.S.C. 346a.                          and Toxics (OPPT), Environmental
                                                  any groups or segments of the                                                                                 Protection Agency, 1200 Pennsylvania
                                                                                                             Dated: October 14, 2016.
                                                  population who, as a result of their                                                                          Ave. NW., Washington, DC 20460–0001.
                                                                                                          Michael Goodis,                                         • Hand Delivery: To make special
                                                  location, cultural practices, or other                  Acting Director, Registration Division, Office
                                                  factors, may have atypical or                                                                                 arrangements for hand delivery or
                                                                                                          of Pesticide Programs.                                delivery of boxed information, please
                                                  disproportionately high and adverse                     [FR Doc. 2016–25926 Filed 10–26–16; 8:45 am]
                                                  human health impacts or environmental                                                                         follow the instructions at http://
                                                  effects from exposure to the pesticides
                                                                                                          BILLING CODE 6560–50–P                                www.epa.gov/dockets/contacts.html.
                                                  discussed in this document, compared                                                                            Additional instructions on
                                                  to the general population.                                                                                    commenting or visiting the docket,
                                                                                                          ENVIRONMENTAL PROTECTION                              along with more information about
                                                  II. What action is the agency taking?                   AGENCY                                                dockets generally, is available at http://
                                                     EPA is announcing receipt of a                                                                             www.epa.gov/dockets.
                                                                                                          40 CFR Part 721
                                                  pesticide petition filed under section                                                                        FOR FURTHER INFORMATION CONTACT: For
                                                                                                          [EPA–HQ–OPPT–2015–0810; FRL–9951–77]                  technical information contact: Kenneth
                                                  408 of the Federal Food, Drug, and
                                                  Cosmetic Act (FFDCA), 21 U.S.C. 346a,                   RIN 2070–AB27                                         Moss, Chemical Control Division
                                                  requesting the establishment or                                                                               (7405M), Office of Pollution Prevention
                                                  modification of regulations in 40 CFR                   Significant New Use Rule on Certain                   and Toxics, Environmental Protection
                                                  part 180 for residues of pesticide                      Chemical Substances                                   Agency, 1200 Pennsylvania Ave. NW.,
                                                  chemicals in or on various food                                                                               Washington, DC 20460–0001; telephone
                                                                                                          AGENCY:  Environmental Protection
                                                  commodities. The Agency is taking                                                                             number: (202) 564–9232; email address:
                                                                                                          Agency (EPA).
                                                  public comment on the request before                                                                          moss.kenneth@epa.gov.
                                                                                                          ACTION: Proposed rule.                                  For general information contact: The
                                                  responding to the petitioner. EPA is not
                                                  proposing any particular action at this                 SUMMARY:   EPA is proposing significant               TSCA-Hotline, ABVI-Goodwill, 422
                                                  time. EPA has determined that the                       new use rules (SNURs) under the Toxic                 South Clinton Ave., Rochester, NY
                                                  pesticide petition described in this                    Substances Control Act (TSCA) for three               14620; telephone number: (202) 554–
                                                  document contains data or information                   chemical substances which were the                    1404; email address: TSCA-Hotline@
                                                  prescribed in FFDCA section 408(d)(2),                  subject of premanufacture notices                     epa.gov.
                                                  21 U.S.C. 346a(d)(2); however, EPA has                  (PMNs). The applicable review periods                 SUPPLEMENTARY INFORMATION:
                                                  not fully evaluated the sufficiency of the              for the PMNs submitted for these
                                                                                                                                                                I. General Information
                                                  submitted data at this time or whether                  chemical substances all ended prior to
                                                  the data supports granting of the                       June 22, 2016, the date on which                      A. Does this action apply to me?
                                                  pesticide petition. After considering the               President Obama signed into law the                      You may be potentially affected by
                                                  public comments, EPA intends to                         Frank R. Lautenberg Chemical Safety for               this action if you manufacture, process,
                                                  evaluate whether and what action may                    the 21st Century Act which amends                     or use the chemical substances
                                                  be warranted. Additional data may be                    TSCA). This action would require                      contained in this proposed rule. The
                                                  needed before EPA can make a final                      persons who intend to manufacture                     following list of North American
                                                  determination on this pesticide petition.               (defined by statute to include import) or             Industrial Classification System
                                                     Pursuant to 40 CFR 180.7(f), a                       process any of the chemical substances                (NAICS) codes is not intended to be
                                                  summary of the petition that is the                     for an activity that is designated as a               exhaustive, but rather provides a guide
                                                  subject of this document, prepared by                   significant new use by this proposed                  to help readers determine whether this
                                                  the petitioner, is included in a docket                 rule to notify EPA at least 90 days before            document applies to them. Potentially
                                                  EPA has created for this rulemaking.                    commencing that activity. The required                affected entities may include:
                                                  The docket for this petition is available               notification initiates EPA’s evaluation of               Manufacturers (including importers)
                                                  at http://www.regulations.gov.                          the intended use within the applicable                or processors of one or more subject
                                                     As specified in FFDCA section                        review period. Manufacture and                        chemical substances (NAICS codes 325
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                                                  408(d)(3), 21 U.S.C. 346a(d)(3), EPA is                 processing for the significant new use is             and 324110), e.g., chemical
                                                  publishing notice of the petition so that               unable to commence until EPA has                      manufacturing and petroleum refineries.
                                                  the public has an opportunity to                        conducted a review of the notice, made                   This action may also affect certain
                                                  comment on this request for the                         an appropriate determination on the                   entities through pre-existing import
                                                  establishment or modification of                        notice, and take such actions as are                  certification and export notification
                                                  regulations for residues of pesticides in               required with that determination.                     rules under TSCA. Chemical importers
                                                  or on food commodities. Further                         DATES: Comments must be received on                   are subject to the TSCA section 13 (15
                                                  information on the petition may be                      or before November 28, 2016.                          U.S.C. 2612) import certification


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                                                  74756                 Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules

                                                  requirements promulgated at 19 CFR                      comments on these SNURs. Therefore,                   to these SNURs must comply with the
                                                  12.118 through 12.127 and 19 CFR                        as required by § 721.160(c)(3)(ii), EPA               same SNUN requirements and EPA
                                                  127.28. Chemical importers must certify                 withdrew the direct final SNURs in the                regulatory procedures as submitters of
                                                  that the shipment of the chemical                       Federal Register of July 14, 2016 (81 FR              PMNs under TSCA section 5(a)(1)(A). In
                                                  substance complies with all applicable                  45416) (FRL–9948–81), and is now                      particular, these requirements include
                                                  rules and orders under TSCA. Importers                  issuing this proposed rule on these three             the information submission
                                                  of chemicals subject to these SNURs                     chemical substances. The records for the              requirements of TSCA section 5(b) and
                                                  must certify their compliance with the                  direct final SNURs on these chemical                  5(d)(1), the exemptions authorized by
                                                  SNUR requirements. The EPA policy in                    substances were established as docket                 TSCA section 5(h)(1), (h)(2), (h)(3), and
                                                  support of import certification appears                 EPA–HQ–OPPT–2015–0810. Those                          (h)(5), and the regulations at 40 CFR
                                                  at 40 CFR part 707, subpart B. In                       records include information considered                part 720. Once EPA receives a SNUN,
                                                  addition, any persons who export or                     by the Agency in developing the direct                EPA must either determine that the
                                                  intend to export a chemical substance to                final rule. While notices of intent to                significant new use is not likely to
                                                  a proposed or final rule are subject to                 submit adverse comments were received                 present an unreasonable risk of injury or
                                                  the export notification provisions of                   during the direct final rule phase, no                take such regulatory action as is
                                                  TSCA section 12(b) (15 U.S.C. 2611(b))                  substantive comments were submitted.                  associated with an alternative
                                                  (see § 721.20), and must comply with                    EPA awaits the adverse comments                       determination before the manufacture or
                                                  the export notification requirements in                 during the open comment period for                    processing for the significant new use
                                                  40 CFR part 707, subpart D.                             this proposed rule. Comments received                 can commence. If EPA determines that
                                                                                                          on the two isocyanate PMN chemicals                   the significant new use is not likely to
                                                  B. What should I consider as I prepare                  in today’s proposed rule will be                      present an unreasonable risk, EPA is
                                                  my comments for EPA?                                    addressed in a final rule with isocyanate             required under TSCA section 5(g) to
                                                     1. Submitting CBI. Do not submit this                PMN chemicals that were the subject of                make public, and submit for publication
                                                  information to EPA through                              previous proposed rules published in                  in the Federal Register, a statement of
                                                  regulations.gov or email. Clearly mark                  the Federal Register at 80 FR 845                     EPA’s findings.
                                                  the part or all of the information that                 (January 7, 2015) and 81 FR 21830
                                                  you claim to be CBI. For CBI                            (April 13, 2016).                                     III. Significant New Use Determination
                                                  information in a disk or CD–ROM that                    B. What is the agency’s authority for                    Section 5(a)(2) of TSCA states that
                                                  you mail to EPA, mark the outside of the                taking this action?                                   EPA’s determination that a use of a
                                                  disk or CD–ROM as CBI and then                                                                                chemical substance is a significant new
                                                  identify electronically within the disk or                 Section 5(a)(2) of TSCA (15 U.S.C.                 use must be made after consideration of
                                                  CD–ROM the specific information that                    2604(a)(2)) authorizes EPA to determine               all relevant factors, including:
                                                                                                          that a use of a chemical substance is a
                                                  is claimed as CBI. In addition to one                                                                            • The projected volume of
                                                  complete version of the comment that                    ‘‘significant new use.’’ EPA must make
                                                                                                                                                                manufacturing and processing of a
                                                  includes information claimed as CBI, a                  this determination by rule after
                                                                                                                                                                chemical substance.
                                                                                                          considering all relevant factors,
                                                  copy of the comment that does not
                                                                                                          including the four bulleted TSCA                         • The extent to which a use changes
                                                  contain the information claimed as CBI                                                                        the type or form of exposure of human
                                                  must be submitted for inclusion in the                  section 5(a)(2) factors listed in Unit III.
                                                                                                          Once EPA determines that a use of a                   beings or the environment to a chemical
                                                  public docket. Information so marked                                                                          substance.
                                                                                                          chemical substance is a significant new
                                                  will not be disclosed except in
                                                                                                          use, TSCA section 5(a)(1)(B) requires                    • The extent to which a use increases
                                                  accordance with procedures set forth in                                                                       the magnitude and duration of exposure
                                                  40 CFR part 2.                                          persons to submit a significant new use
                                                                                                          notice (SNUN) to EPA at least 90 days                 of human beings or the environment to
                                                     2. Tips for preparing your comments.                                                                       a chemical substance.
                                                  When preparing and submitting your                      before they manufacture or process the
                                                                                                          chemical substance for that use (15                      • The reasonably anticipated manner
                                                  comments, see the commenting tips at                                                                          and methods of manufacturing,
                                                  http://www.epa.gov/dockets/                             U.S.C. 2604(a)(1)(B)(i)). TSCA
                                                                                                          furthermore prohibits such                            processing, distribution in commerce,
                                                  comments.html.                                                                                                and disposal of a chemical substance.
                                                                                                          manufacturing or processing from
                                                  II. Background                                          commencing until EPA has conducted a                     In addition to these factors
                                                                                                          review of the notice, made an                         enumerated in TSCA section 5(a)(2), the
                                                  A. What action is the agency taking?                                                                          statute authorized EPA to consider any
                                                                                                          appropriate determination on the notice,
                                                    EPA is proposing these SNURs under                    and taken such actions as are required                other relevant factors.
                                                  TSCA section 5(a)(2) for three chemical                 in association with that determination                   To determine what would constitute a
                                                  substances which were the subject of                    (15 U.S.C. 2604(a)(1)(B)(ii)). As                     significant new use for the chemical
                                                  PMNs P–15–276, P–15–378, and P–15–                      described in Unit V., the general SNUR                substances that are the subject of these
                                                  559. These SNURs would require                          provisions are found at 40 CFR part 721,              SNURs, EPA considered relevant
                                                  persons who intend to manufacture or                    subpart A.                                            information about the toxicity of the
                                                  process any of these chemical                                                                                 chemical substances, likely human
                                                  substances for an activity that is                      C. Applicability of General Provisions                exposures and environmental releases
                                                  designated as a significant new use to                     General provisions for SNURs appear                associated with possible uses, and the
                                                  notify EPA at least 90 days before                      in 40 CFR part 721, subpart A. These                  four bulleted TSCA section 5(a)(2)
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                                                  commencing that activity. In accordance                 provisions describe persons subject to                factors listed in this unit.
                                                  with the procedures at § 721.160(c)(3)(i),              the rule, recordkeeping requirements,
                                                                                                                                                                IV. Substances Subject to This Proposed
                                                  in the Federal Register publication of                  exemptions to reporting requirements,
                                                                                                                                                                Rule
                                                  May 16, 2016 (81 FR 30452) (FRL–9944–                   and applicability of the rule to uses
                                                  77) EPA issued direct final SNURs on                    occurring before the effective date of the              EPA is proposing significant new use
                                                  these chemical substances, which are                    final rule. Provisions relating to user               and recordkeeping requirements for
                                                  the subject of PMNs. EPA received                       fees appear at 40 CFR part 700.                       three chemical substances in 40 CFR
                                                  notices of intent to submit adverse                     According to § 721.1(c), persons subject              part 721, subpart E. In this unit, EPA


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                                                                        Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules                                         74757

                                                  provides the following information for                     CAS number: Claimed confidential.                  the health and environmental effects of
                                                  each chemical substance:                                   Basis for action: The PMN states that              the PMN substance.
                                                     • PMN number.                                        the substance will be used as a thin film               CFR citation: 40 CFR 721.10902.
                                                     • Chemical name (generic name, if                    for electronic device applications. Based
                                                  the specific name is claimed as CBI).                                                                         PMN Number P–15–378
                                                                                                          on SAR analysis of test data on
                                                     • Chemical Abstracts Service (CAS)                   analogous carbon nanotubes and other                     Chemical name: Diisocyanato hexane,
                                                  Registry number (assigned for non-                      respirable poorly soluble particulates,               homopolymer, alkanoic acid-
                                                  confidential chemical identities).                      EPA identified potential lung effects                 polyalkylene glycol ether with
                                                     • Public comments and EPA’s                                                                                substituted alkane (3:1) reaction
                                                                                                          and skin penetration and toxicity
                                                  response to comments on the three                                                                             products-blocked (generic).
                                                                                                          induction from inhalation and dermal
                                                  direct final SNURs                                                                                               CAS number: Claimed confidential.
                                                     • Basis for the TSCA non-section 5(e)                exposure to the PMN substance.                           Basis for action: The PMN states that
                                                  SNURs (i.e., SNURs without TSCA                         Further, EPA predicts toxicity to aquatic             the substance will be used as a dual
                                                  section 5(e) consent orders).                           organisms via releases of the PMN                     cure/UV cure adhesion/barrier coating
                                                     • Tests recommended by EPA to                        substance to surface water. Although                  for wood substrates. Based on SAR
                                                  provide sufficient information to                       there is potential for dermal exposure,               analysis of test data on analogous
                                                  evaluate the chemical substance (see                    EPA does not expect significant                       diisocyanates, EPA identified concerns
                                                  Unit VII. for more information).                        occupational exposures due to the use                 for respiratory sensitization.
                                                     • CFR citation assigned in the                       of impervious gloves, and because the                 Furthermore, the National Institute for
                                                  regulatory text section of this proposed                PMN is used in a liquid and is not spray              Occupational Safety and Health
                                                  rule.                                                   applied except in a closed system.                    (NIOSH) alert at http://www.cdc.gov/
                                                  The regulatory text section of this                     Further, EPA does not expect                          niosh/docs/2006-149/pdfs/2006-149.pdf
                                                  proposed rule specifies the activities                  environmental releases during the use                 summarizes four case reports: one death
                                                  designated as significant new uses.                     identified in the PMN submission.                     and several incidents of asthma or other
                                                  Certain new uses, including production                  Therefore, EPA has not determined that                respiratory disease following exposure
                                                  volume limits (i.e., limits on                          the proposed manufacturing,                           to methylenebis(phenyl isocyanate)
                                                  manufacture volume) and other uses                      processing, and or use of the substance               (MDI) during spray-on truck bed lining
                                                  designated in this proposed rule, may be                may present an unreasonable risk to                   operations. For this PMN substance, a
                                                  claimed as CBI.                                         human health or the environment. EPA                  significant new use is any use of the
                                                     The three PMN substances included                    has determined, however, that any use                 substance without a NIOSH-certified
                                                  in this rulemaking are not subject to                   of the substance without the use of                   particulate respirator with an APF of at
                                                  consent orders under TSCA section 5(e).                 impervious gloves, where there is                     least 10 where there is a potential for
                                                  These cases completed Agency review                     potential for dermal exposure;                        inhalation exposure, or any use in
                                                  prior to June 22, 2016. Under TSCA,                     manufacturing the PMN substance for                   consumer products. For new
                                                  prior to the enactment of the Frank R.                  use other than as a thin film for                     isocyanates submitted as PMNs, EPA
                                                  Lautenberg Chemical Safety for the 21st                 electronic device applications;                       expects to issue TSCA section 5(e)
                                                  Century Act on June 22, 2016, EPA did                   manufacturing, processing, or using the               orders imposing 0.1% limits on total
                                                  not find that the use scenario described                PMN substance in a form other than a                  residual isocyanates and greater levels
                                                  in the PMN triggered the determinations                 liquid; use of the PMN substance                      of respiratory protection (at least an APF
                                                  set forth under TSCA section 5(e).                      involving an application method that                  of 50, or 1000 if used in a process that
                                                  However, EPA does believe that certain                  generates a mist, vapor, or aerosol                   generates a vapor or particulate), and no
                                                  changes from the use scenario described                 except in a closed system; or any release             consumer use. The Agency would then
                                                  in the PMN could result in increased                    of the PMN substance into surface                     likely issue a SNUR defining the
                                                  exposures, thereby constituting a                       waters or disposal other than by landfill             significant new use as total residual
                                                  ‘‘significant new use.’’ These so-called                or incineration may cause serious health              isocyanates exceeding that 0.1% limit
                                                  ‘‘non-TSCA section 5(e) SNURs’’ are                     effects or significant adverse                        and any use in a consumer product.
                                                  consistent with the determination made                  environmental effects. Based on this                  However, as mentioned in Unit VI.,
                                                  at the time and are promulgated                         information, the PMN substance meets                  below, and in the original May 16, 2016
                                                  pursuant to § 721.170. EPA has                          the concern criteria at § 721.170                     direct final rule, EPA designated that
                                                  determined that every activity                          (b)(3)(ii) and (b)(4)(ii).                            date as the cutoff date for determining
                                                  designated as a ‘‘significant new use’’ in                 Recommended testing: EPA has                       whether the new use is ongoing.
                                                  all non-TSCA section 5(e) SNURs issued                  determined that the results of a fish                 Furthermore, a Notice of
                                                  under § 721.170 satisfies the two                       early-life stage toxicity test (OPPTS Test            Commencement of Manufacture or
                                                  requirements stipulated in                              Guideline 850.1400); a daphnid chronic                Import was submitted and the chemical
                                                  § 721.170(c)(2), i.e., these significant                toxicity test (OPPTS Test Guideline                   substance is now on the TSCA
                                                  new use activities, ‘‘(i) are different from            850.1300); an algal toxicity test (OCSPP              Inventory and is being used with
                                                  those described in the premanufacture                   Test Guideline 850.4500); a 90-day                    respiratory protection with an APF of
                                                  notice for the substance, including any                 inhalation toxicity test (OPPTS                       less than 50. For these reasons, EPA is
                                                  amendments, deletions, and additions                    870.3465) with additional testing                     not changing the terms of the original
                                                  of activities to the premanufacture                     parameters beyond those noted at CFR                  direct final SNUR for this PMN
                                                                                                          870.3465, for using the 90-day                        substance. Based on this information,
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                                                  notice, and (ii) may be accompanied by
                                                  changes in exposure or release levels                   subchronic protocol for nanomaterial                  the PMN substance meets the concern
                                                  that are significant in relation to the                 assessment; a two-year inhalation                     criteria at § 721.170(b)(3)(ii).
                                                  health or environmental concerns                        bioassay (OPPTS Test Guideline                           Recommended testing: EPA has
                                                  identified’’ for the PMN substance.                     870.4200); and a surface charge by                    determined that the results of a skin
                                                                                                          electrophoresis (for example, using                   sensitization test (OPPTS Test Guideline
                                                  PMN Number P–15–276                                     ASTM E2865–12 or NCL Method PCC–                      870.2600) and a 90-day inhalation
                                                    Chemical name: Functionalized                         2—Measuring the Zeta Potential of                     toxicity test (OPPTS Test Guideline
                                                  carbon nanotubes (generic).                             Nanoparticles) would help characterize                870.3465) would help characterize the


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                                                  74758                 Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules

                                                  human health effects of the PMN                         human health effects of the PMN                       submitting a PMN. Therefore, for
                                                  substance.                                              substance.                                            chemical substances for which an NOC
                                                    CFR citation: 40 CFR 721.10913.                         CFR citation: 40 CFR 721.10920.                     has not been submitted EPA concludes
                                                  PMN Number P–15–559                                                                                           that the designated significant new uses
                                                                                                          V. Rationale and Objectives of the
                                                                                                                                                                are not ongoing.
                                                     Chemical name: Modified                              Proposed Rule                                            When chemical substances identified
                                                  diphenylmethane diisocyanate                            A. Rationale                                          in this proposed rule are added to the
                                                  prepolymer with polyol (generic).                                                                             TSCA Inventory, EPA recognizes that,
                                                     CAS number: Claimed confidential.                      During review of the PMNs submitted                 before the rule is effective, other persons
                                                     Basis for action: The PMN states that                for the chemical substances that are                  might engage in a use that has been
                                                  the generic (non-confidential) use of the               subject to these SNURs, EPA                           identified as a significant new use. The
                                                  substance will be as a raw material for                 determined that one or more of the                    identities of the three chemical
                                                  flexible foam. Based on SAR analysis of                 criteria of concern established at                    substances subject to this proposed rule
                                                  analogous diisocyanates, EPA identified                 § 721.170 were met. For additional                    have been claimed as confidential and
                                                  concerns for potential dermal and                       discussion on these chemical                          EPA has received no post-PMN bona
                                                  respiratory sensitization from dermal                   substances, see Units II. and IV. of this             fide submissions (per §§ 720.25 and
                                                  and inhalation exposures, and for                       proposed rule.                                        721.11). Based on this, the Agency
                                                  pulmonary toxicity from inhalation                      B. Objectives                                         believes that it is highly unlikely that
                                                  exposure, to the PMN substance where                                                                          any of the significant new uses
                                                  the average molecular weight is below                      EPA is proposing these SNURs for                   described in the regulatory text of this
                                                  7,500 daltons and any molecular weight                  specific chemical substances which                    proposed rule are ongoing.
                                                  species is below 1,000 daltons. For the                 have undergone premanufacture review                     Therefore, as mentioned in the
                                                  molecular weight distribution described                 because the Agency wants to achieve                   original May 16, 2016 direct final rule,
                                                  in the PMN, significant occupational                    the following objectives with regard to               EPA designated that date as the cutoff
                                                  exposures are not expected. Therefore,                  the significant new uses designated in                date for determining whether the new
                                                  EPA has not determined that the                         this proposed rule:                                   use is ongoing. Persons who begin
                                                  proposed manufacture of the substance                      • EPA would receive notice of any                  commercial manufacture or processing
                                                  may present an unreasonable risk. EPA                   person’s intent to manufacture or                     of the chemical substances for a
                                                  has determined, however, that any                       process a listed chemical substance for               significant new use identified as of that
                                                  manufacture of the PMN substance with                   the described significant new use before              May 16, 2016 date would have to cease
                                                  an average molecular weight below                       that activity begins.                                 any such activity upon the effective date
                                                  7,500 daltons, and where any molecular                     • EPA would have an opportunity to                 of the final rule. To resume their
                                                  weight species is below 1,000 daltons                   review and evaluate data submitted in a               activities, these persons would have to
                                                  may cause serious health effects. For                   SNUN before the notice submitter                      first comply with all applicable SNUR
                                                  new isocyanates submitted as PMNs,                      begins manufacturing or processing a                  notification requirements and wait until
                                                  EPA expects to issue TSCA section 5(e)                  listed chemical substance for the                     the notice review period, including any
                                                  orders imposing 0.1% limits on total                    described significant new use.                        extensions, expires. If such a person met
                                                  residual isocyanates and greater levels                    • EPA would be able to either                      the conditions of advance compliance
                                                  of respiratory protection (at least an APF              determine that the prospective                        under § 721.45(h), the person would be
                                                  of 50, or 1000 if used in a process that                manufacture or processing is not likely               considered exempt from the
                                                  generates a vapor or particulate), and no               to present an unreasonable risk, or to                requirements of the SNUR. Consult the
                                                  consumer use. The Agency would then                     take necessary regulatory action                      Federal Register document of April 24,
                                                  likely issue a SNUR defining the                        associated with any other                             1990 (55 FR 17376) for a more detailed
                                                  significant new use as total residual                   determination, before the described                   discussion of the cutoff date for ongoing
                                                  isocyanates exceeding that 0.1% limit                   significant new use of the chemical                   uses.
                                                  and any use in a consumer product.                      substance occurs.
                                                  However, as mentioned in Unit VI.,                         Issuance of a SNUR for a chemical                  VII. Development and Submission of
                                                  below, and in the original May 16, 2016                 substance does not signify that the                   Information
                                                  direct final rule, EPA designated that                  chemical substance is listed on the                     EPA recognizes that TSCA section 5
                                                  date as the cutoff date for determining                 TSCA Chemical Substance Inventory                     does not require developing any
                                                  whether the new use is ongoing.                         (TSCA Inventory). Guidance on how to                  particular new information (e.g.,
                                                  Furthermore, a Notice of                                determine if a chemical substance is on               generating test data) before submission
                                                  Commencement of Manufacture or                          the TSCA Inventory is available on the                of a SNUN. There is an exception:
                                                  Import was submitted and the chemical                   Internet at https://www.epa.gov/tsca-                 development of test data is required
                                                  substance is now on the TSCA                            inventory.                                            where the chemical substance subject to
                                                  Inventory and is being used with                                                                              the SNUR is also subject to a rule, order
                                                                                                          VI. Applicability of the Proposed Rule
                                                  respiratory protection with an APF of                                                                         or consent agreement under TSCA
                                                                                                          to Uses Occurring Before the Effective
                                                  less than 50. For these reasons, EPA is                                                                       section 4 (see TSCA section 5(b)(1)).
                                                                                                          Date of the Final Rule                                  In the absence of a TSCA section 4
                                                  not changing the terms of the original
                                                  direct final SNUR for this PMN                            To establish a significant new use,                 test rule covering the chemical
                                                  substance. Based on this information,                   EPA must determine that the use is not                substance, persons are required only to
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                                                  the PMN substance meets the concern                     ongoing. The chemical substances                      submit information in their possession
                                                  criteria at § 721.170(b)(3)(ii).                        subject to this proposed rule have                    or control and to describe any other
                                                     Recommended testing: EPA has                         undergone premanufacture review. In                   information known to or reasonably
                                                  determined that the results of a skin                   cases where EPA has not received a                    ascertainable by them (see 40 CFR
                                                  sensitization test (OPPTS Test Guideline                notice of commencement (NOC) and the                  720.50). However, upon review of PMNs
                                                  870.2600) and a 90-day inhalation                       chemical substance has not been added                 and SNUNs, the Agency has the
                                                  toxicity test (OPPTS Test Guideline                     to the TSCA Inventory, no person may                  authority to require appropriate testing.
                                                  870.3465) would help characterize the                   commence such activities without first                Descriptions of tests are provided for


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                                                                        Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules                                        74759

                                                  informational purposes. EPA strongly                    assurance, and analyses employed in                   No. 574). This proposed rule would not
                                                  encourages persons, before performing                   EPA’s decision are documented, as                     impose any burden requiring additional
                                                  any testing, to consult with the Agency                 applicable and to the extent necessary                OMB approval. If an entity were to
                                                  pertaining to protocol selection. To                    for purposes of this proposed significant             submit a SNUN to the Agency, the
                                                  access the OCSPP test guidelines                        new use rule, in Unit II and in the                   annual burden is estimated to average
                                                  referenced in this document                             documents noted above. EPA                            between 30 and 170 hours per response.
                                                  electronically, please go to http://                    recognizes, based on the available                    This burden estimate includes the time
                                                  www.epa.gov/ocspp and select ‘‘Test                     information, that there is variability and            needed to review instructions, search
                                                  Guidelines for Pesticides and Toxic                     uncertainty in whether any particular                 existing data sources, gather and
                                                  Substances.’’                                           significant new use would actually                    maintain the data needed, and
                                                     The recommended tests specified in                   present an unreasonable risk. For                     complete, review, and submit the
                                                  Unit IV. may not be the only means of                   precisely this reason, it is appropriate to           required SNUN.
                                                  addressing the potential risks of the                   secure a future notice and review                       Send any comments about the
                                                  chemical substance. However,                            process for these uses, at such time as               accuracy of the burden estimate, and
                                                  submitting a SNUN without any test                      they are known more definitely. The                   any suggested methods for minimizing
                                                  data may increase the likelihood that                   extent to which the various information,              respondent burden, including through
                                                  EPA will take action under TSCA                         procedures, measures, methods,                        the use of automated collection
                                                  section 5(e), particularly if satisfactory              protocols, methodologies or models                    techniques, to the Director, Collection
                                                  test results have not been obtained from                used in EPA’s decision have been                      Strategies Division, Office of
                                                  a prior PMN or SNUN submitter. EPA                      subject to independent verification or                Environmental Information (2822T),
                                                  recommends that potential SNUN                          peer review is adequate to justify their              Environmental Protection Agency, 1200
                                                  submitters contact EPA early enough so                  use, collectively, in the record for a                Pennsylvania Ave. NW., Washington,
                                                  that they will be able to conduct the                   significant new use rule.                             DC 20460–0001. Please remember to
                                                  appropriate tests.                                                                                            include the OMB control number in any
                                                     SNUN submitters should be aware                      X. Economic Analysis                                  correspondence, but do not submit any
                                                  that EPA will be better able to evaluate                  EPA has evaluated the potential costs               completed forms to this address.
                                                  SNUNs and define the terms of any                       of establishing SNUN requirements for
                                                  potentially necessary controls if the                                                                         C. Regulatory Flexibility Act (RFA)
                                                                                                          potential manufacturers and processors
                                                  submitter provides detailed information                 of the chemical substances subject to                   On February 18, 2012, EPA certified
                                                  on the following:                                       this proposed rule, during the                        pursuant to RFA section 605(b) (5 U.S.C.
                                                     • Human exposure and                                 development of the direct final rule.                 601 et seq.), that promulgation of a
                                                  environmental release that may result                   EPA’s complete economic analysis is                   SNUR does not have a significant
                                                  from the significant new use of the                     available in the docket under docket ID               economic impact on a substantial
                                                  chemical substances.                                    number EPA–HQ–OPPT–2015–0810.                         number of small entities where the
                                                  VIII. SNUN Submissions                                                                                        following are true:
                                                                                                          XI. Statutory and Executive Order                       1. A significant number of SNUNs
                                                    According to § 721.1(c), persons                      Reviews                                               would not be submitted by small
                                                  submitting a SNUN must comply with                      A. Executive Order 12866                              entities in response to the SNUR.
                                                  the same notification requirements and                                                                          2. The SNUR submitted by any small
                                                  EPA regulatory procedures as persons                      This proposed rule would establish                  entity would not cost significantly more
                                                  submitting a PMN, including                             SNURs for three chemical substances                   than $8,300.
                                                  submission of test data on health and                   that were the subject of PMNs. The                      A copy of that certification is
                                                  environmental effects as described in 40                Office of Management and Budget                       available in the docket for this proposed
                                                  CFR 720.50. SNUNs must be submitted                     (OMB) has exempted these types of                     rule.
                                                  on EPA Form No. 7710–25, generated                      actions from review under Executive                     This proposed rule is within the
                                                  using e-PMN software, and submitted to                  Order 12866, entitled ‘‘Regulatory                    scope of the February 18, 2012
                                                  the Agency in accordance with the                       Planning and Review’’ (58 FR 51735,                   certification. Based on the Economic
                                                  procedures set forth in 40 CFR 720.40                   October 4, 1993).                                     Analysis discussed in Unit IX. and
                                                  and 721.25. E–PMN software is                           B. Paperwork Reduction Act (PRA)                      EPA’s experience promulgating SNURs
                                                  available electronically at https://                                                                          (discussed in the certification), EPA
                                                  www.epa.gov/reviewing-new-chemicals-                      According to PRA (44 U.S.C. 3501 et                 believes that the following are true:
                                                  under-toxic-substances-control-act-tsca/                seq.), an agency may not conduct or                     • A significant number of SNUNs
                                                  how-submit-e-pmn.                                       sponsor, and a person is not required to              would not be submitted by small
                                                                                                          respond to a collection of information                entities in response to the SNUR.
                                                  IX. Scientific Standards, Evidence, and                 that requires OMB approval under PRA,                   • Submission of the SNUN would not
                                                  Available Information                                   unless it has been approved by OMB                    cost any small entity significantly more
                                                    EPA has used scientific information,                  and displays a currently valid OMB                    than $8,300.
                                                  technical procedures, measures,                         control number. The OMB control                         Therefore, the promulgation of the
                                                  methods, protocols, methodologies, and                  numbers for EPA’s regulations in title 40             SNUR would not have a significant
                                                  models consistent with the risk                         of the CFR, after appearing in the                    economic impact on a substantial
                                                  assessment documents included in the                    Federal Register, are listed in 40 CFR                number of small entities.
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                                                  public docket. These information                        part 9, and included on the related
                                                  sources supply information relevant to                  collection instrument or form, if                     D. Unfunded Mandates Reform Act
                                                  whether a particular use would be a                     applicable.                                           (UMRA)
                                                  significant new use, based on relevant                    The information collection                            Based on EPA’s experience with
                                                  factors including those listed under                    requirements related to this proposed                 proposing and finalizing SNURs, State,
                                                  TSCA section 5(a)(2).                                   rule have already been approved by                    local, and Tribal governments have not
                                                    The clarity and completeness of the                   OMB pursuant to PRA under OMB                         been impacted by these rulemakings,
                                                  data, assumptions, methods, quality                     control number 2070–0012 (EPA ICR                     and EPA does not have any reasons to


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                                                  74760                 Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules

                                                  believe that any State, local, or Tribal                standards, NTTAA section 12(d) (15                    use is use other than as a thin film for
                                                  government would be impacted by this                    U.S.C. 272 note), would not apply to                  electronic device applications or any
                                                  proposed rule. As such, EPA has                         this proposed rule.                                   use involving an application method
                                                  determined that this proposed rule                                                                            that generates a vapor, mist, or aerosol
                                                                                                          J. Executive Order 12898
                                                  would not impose any enforceable duty,                                                                        unless such application method occurs
                                                  contain any unfunded mandate, or                           This proposed rule does not entail                 in an enclosed process. An enclosed
                                                  otherwise have any effect on small                      special considerations of environmental               process is defined as an operation that
                                                  governments subject to the requirements                 justice related issues as delineated by               is designed and operated so that there
                                                  of UMRA sections 202, 203, 204, or 205                  Executive Order 12898, entitled                       is no release associated with normal or
                                                  (2 U.S.C. 1501 et seq.).                                ‘‘Federal Actions to Address                          routine production processes into the
                                                                                                          Environmental Justice in Minority                     environment of any substance present in
                                                  E. Executive Order 13132                                Populations and Low-Income                            the operation. An operation with
                                                     This proposed rule would not have a                  Populations’’ (59 FR 7629, February 16,               inadvertent or emergency pressure relief
                                                  substantial direct effect on States, on the             1994).                                                releases remains an enclosed process so
                                                  relationship between the national                                                                             long as measures are taken to prevent
                                                                                                          List of Subjects in 40 CFR Part 721
                                                  government and the States, or on the                                                                          worker exposure to and environmental
                                                  distribution of power and                                 Environmental protection, Chemicals,                contamination from the releases.
                                                  responsibilities among the various                      Hazardous substances, Reporting and                      (iii) Disposal. Requirements as
                                                  levels of government, as specified in                   recordkeeping requirements.                           specified in § 721.85 (a)(1), (a)(2), (b)(1),
                                                  Executive Order 13132, entitled                            Dated: October 19, 2016.                           (b)(2), (c)(1), and (c)(2).
                                                  ‘‘Federalism’’ (64 FR 43255, August 10,                 Maria J. Doa,                                            (iv) Release to water. Requirements as
                                                  1999).                                                  Director, Chemical Control Division, Office           specified in § 721.90 (a)(1), (b)(1), and
                                                  F. Executive Order 13175                                of Pollution Prevention and Toxics.                   (c)(1).
                                                                                                                                                                   (b) Specific requirements. The
                                                     This proposed rule would not have                      Therefore, it is proposed that 40 CFR               provisions of subpart A of this part
                                                  Tribal implications because it is not                   chapter I be amended as follows:                      apply to this section except as modified
                                                  expected to have substantial direct                                                                           by this paragraph.
                                                  effects on Indian Tribes. This proposed                 PART 721—[AMENDED]
                                                                                                                                                                   (1) Recordkeeping. Recordkeeping
                                                  rule would not significantly nor                        ■ 1. The authority citation for part 721              requirements as specified in § 721.125
                                                  uniquely affect the communities of                      continues to read as follows:                         (a) through (e), (i), (j), and (k) are
                                                  Indian Tribal governments, nor would it                                                                       applicable to manufacturers and
                                                  involve or impose any requirements that                   Authority: 15 U.S.C. 2604, 2607, and
                                                                                                          2625(c).
                                                                                                                                                                processors of this substance.
                                                  affect Indian Tribes. Accordingly, the                                                                           (2) Limitations or revocation of
                                                  requirements of Executive Order 13175,                  ■ 2. Add § 721.10902 to subpart E to                  certain notification requirements. The
                                                  entitled ‘‘Consultation and Coordination                read as follows:                                      provisions of § 721.185 apply to this
                                                  with Indian Tribal Governments’’ (65 FR                                                                       section.
                                                                                                          § 721.10902 Functionalized carbon
                                                  67249, November 9, 2000), do not apply                  nanotubes (generic).                                  ■ 3. Add § 721.10913 to subpart E to
                                                  to this proposed rule.                                                                                        read as follows:
                                                                                                             (a) Chemical substance and
                                                  G. Executive Order 13045                                significant new uses subject to reporting.            § 721.10913 Diisocyanato hexane,
                                                     This proposed rule is not subject to                 (1) The chemical substance identified                 homopolymer, alkanoic acid-polyalkylene
                                                  Executive Order 13045, entitled                         generically as functionalized carbon                  glycol ether with substituted alkane (3:1)
                                                                                                          nanotubes (PMN P–15–276) is subject to                reaction products-blocked (generic).
                                                  ‘‘Protection of Children from
                                                  Environmental Health Risks and Safety                   reporting under this section for the                    (a) Chemical substance and
                                                  Risks’’ (62 FR 19885, April 23, 1997),                  significant new uses described in                     significant new uses subject to reporting.
                                                  because this is not an economically                     paragraph (a)(2) of this section. The                 (1) The chemical substance identified
                                                  significant regulatory action as defined                requirements of this rule do not apply                generically as diisocyanato hexane,
                                                  by Executive Order 12866, and this                      to quantities of the PMN substance after              homopolymer, alkanoic acid-
                                                  proposed rule does not address                          it has been completely reacted (cured).               polyalkylene glycol ether with
                                                  environmental health or safety risks                       (2) The significant new uses are:                  substituted alkane (3:1) reaction
                                                  disproportionately affecting children.                     (i) Protection in the workplace.                   products-blocked (PMN P–15–378) is
                                                                                                          Requirements as specified in                          subject to reporting under this section
                                                  H. Executive Order 13211                                § 721.63(a)(1), (a)(2)(i), and (a)(3). When           for the significant new uses described in
                                                     This proposed rule is not subject to                 determining which persons are                         paragraph (a)(2) of this section.
                                                  Executive Order 13211, entitled                         reasonably likely to be exposed as                      (2) The significant new uses are:
                                                  ‘‘Actions Concerning Regulations That                   required for § 721.63(a)(1), engineering                (i) Protection in the workplace.
                                                  Significantly Affect Energy Supply,                     control measures (e.g., enclosure or                  Requirements as specified in
                                                  Distribution, or Use’’ (66 FR 28355, May                confinement of the operation, general                 § 721.63(a)(4), (a)(6)(ii), and (c). When
                                                  22, 2001), because this proposed rule is                and local ventilation) or administrative              determining which persons are
                                                  not expected to affect energy supply,                   control measures (e.g., workplace                     reasonably likely to be exposed as
                                                  distribution, or use and because this                   policies and procedures) shall be                     required for § 721.63(a)(4), engineering
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                                                  proposed rule is not a significant                      considered and implemented to prevent                 control measures (e.g., enclosure or
                                                  regulatory action under Executive Order                 exposure, where feasible.                             confinement of the operation, general
                                                  12866.                                                     (ii) Industrial, commercial, and                   and local ventilation) or administrative
                                                                                                          consumer activities. Requirements as                  control measures (e.g., workplace
                                                  I. National Technology Transfer and                     specified in § 721.80. A significant new              policies and procedures) shall be
                                                  Advancement Act (NTTAA)                                 use is manufacture, process, or use of                considered and implemented to prevent
                                                     In addition, since this proposed rule                the PMN substance other than in a                     exposure, where feasible. The following
                                                  would not involve any technical                         liquid formulation. A significant new                 National Institute for Occupational


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                                                                        Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Proposed Rules                                              74761

                                                  Safety and Health (NIOSH)-certified                     (a), (b), (c), (d), and (i) are applicable to           (i) Industrial, commercial, and
                                                  respirators with an assigned protection                 manufacturers and processors of this                  consumer activities. Requirements as
                                                  factor (APF) of at least 10 meet the                    substance.                                            specified in § 721.80. A significant new
                                                  requirements of § 721.63(a)(4):                            (2) Limitations or revocation of                   use of the substance is manufacture of
                                                    (A) NIOSH-certified power air-                        certain notification requirements. The                the substance where the average
                                                  purifying respirator with a hood or                     provisions of § 721.185 apply to this                 molecular weight is below 7,500
                                                  helmet and with appropriate gas/vapor                   section.                                              daltons, and where any molecular
                                                  (acid gas, organic vapor, or substance                                                                        weight species is below 1,000 daltons.
                                                                                                          ■ 4. Add § 721.10920 to subpart E to
                                                  specific) cartridges in combination with                                                                        (ii) [Reserved].
                                                  HEPA filters.                                           read as follows:
                                                                                                                                                                  (b) Specific requirements. The
                                                    (B) NIOSH-certified continuous flow                   § 721.10920 Modified diphenylmethane                  provisions of subpart A of this part
                                                  supplied-air respirator equipped with a                 diisocyanate prepolymer with polyol                   apply to this section except as modified
                                                  loose fitting facepiece, hood, or helmet.               (generic).                                            by this paragraph.
                                                    (C) NIOSH-certified negative pressure                                                                         (1) Recordkeeping. Recordkeeping
                                                                                                            (a) Chemical substance and
                                                  (demand) supplied-air respirator with a                                                                       requirements as specified in § 721.125
                                                  full facepiece.                                         significant new uses subject to reporting.
                                                                                                          (1) The chemical substance identified                 (a), (b), (c), and (i) are applicable to
                                                    (ii) Industrial, commercial, and
                                                                                                          generically as modified                               manufacturers and processors of this
                                                  consumer activities. Requirements as
                                                                                                          diphenylmethane diisocyanate                          substance.
                                                  specified in § 721.80(o).
                                                    (b) Specific requirements. The                        perpolymer with polyol (PMN P–15–                        (2) Limitations or revocation of
                                                  provisions of subpart A of this part                    559) is subject to reporting under this               certain notification requirements. The
                                                  apply to this section except as modified                section for the significant new uses                  provisions of § 721.185 apply to this
                                                  by this paragraph.                                      described in paragraph (a)(2) of this                 section.
                                                    (1) Recordkeeping. Recordkeeping                      section.                                              [FR Doc. 2016–25933 Filed 10–26–16; 8:45 am]
                                                  requirements as specified in § 721.125                    (2) The significant new uses are:                   BILLING CODE 6560–50–P
sradovich on DSK3GMQ082PROD with PROPOSALS




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Document Created: 2016-10-27 01:52:45
Document Modified: 2016-10-27 01:52:45
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 November 28, 2016.
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 Citation81 FR 74755 
RIN Number2070-AB27
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements

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