81_FR_85700 81 FR 85472 - Alkylpyrrolidones; Significant New Use Rule

81 FR 85472 - Alkylpyrrolidones; Significant New Use Rule

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 228 (November 28, 2016)

Page Range85472-85478
FR Document2016-28565

Under the Toxic Substance Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for two alkylpyrrolidones: N- ethylpyrrolidone (NEP) and N-isopropylpyrrolidone (NiPP). The proposed significant new uses are any use of NiPP and any use of NEP except for the ongoing uses as a reactant, in silicone seal remover, coatings, consumer and commercial paint primer, and adhesives. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing of the chemical substance for a significant new use. The required notification initiates EPA's evaluation of the conditions of 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 taken such actions as are required in association with that determination.

Federal Register, Volume 81 Issue 228 (Monday, November 28, 2016)
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Proposed Rules]
[Pages 85472-85478]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28565]



[[Page 85472]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2015-0387; FRL-9945-53]
RIN 2070-AK09


Alkylpyrrolidones; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing 
a significant new use rule (SNUR) for two alkylpyrrolidones: N-
ethylpyrrolidone (NEP) and N-isopropylpyrrolidone (NiPP). The proposed 
significant new uses are any use of NiPP and any use of NEP except for 
the ongoing uses as a reactant, in silicone seal remover, coatings, 
consumer and commercial paint primer, and adhesives. Persons subject to 
the SNUR would be required to notify EPA at least 90 days before 
commencing any manufacturing or processing of the chemical substance 
for a significant new use. The required notification initiates EPA's 
evaluation of the conditions of 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 taken such actions as 
are required in association with that determination.

DATES: Comments must be received on or before January 27, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2015-0387, 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: 
Tyler Lloyd, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-4016; 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 distribute in commerce chemical substances and mixtures. 
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:
     Ship Building and Repairing (NAICS code 336611).
     Aircraft Manufacturing (NAICS code 336411).
     Museums (NAICS code 712110).
     Independent Artists, Writers, and Performers (NAICS code 
711510).
     Reupholster and Furniture Repair (NAICS code 811420).
     Automotive Body Paint and Interior Repair Maintenance 
(NAICS code 811121).
     Flooring Contractors (NAICS code 238330).
     Painting and Wall Covering Contractors (NAICS code 
238320).
     Adhesive Tape Manufacturing (NAICS code 339113).
     Adhesive Manufacturing (NAICS code 325520).
     Denture Adhesive Manufacturing (NAICS code 325620).
     Basic Chemical Manufacturing (NAICS code 325411).
     Pharmaceutical and Medicine Manufacturing (NAICS code 
32541).
     Printing Ink Manufacturing (NAICS code 325910).
     Textile Leather Manufacturing (NAICS code 316998).
     Textile Manufacturing (NAICS code 325613).
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Those persons must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA, including any 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 that is the subject of this proposed rule on or after 
December 28, 2016 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical information 
contact listed under FOR FURTHER INFORMATION CONTACT.

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 those listed in TSCA section 5(a)(2) (see 
Unit IV.). Once EPA determines that a use of a chemical substance is a 
significant new use, TSCA section 5(a)(1) requires persons to submit a 
significant new use notice (SNUN) to EPA at least 90 days before they 
manufacture (including import) 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. What action is the agency taking?

    EPA is proposing a SNUR for two alkylpyrrolidones: N-
ethylpyrrolidone (NEP) and N-isopropylpyrrolidone (NiPP). The proposed 
significant new uses are any use of NiPP and any use of NEP except for 
the ongoing uses as a reactant, in silicone seal remover, coatings, 
consumer and commercial paint primer, and adhesives. The

[[Page 85473]]

proposed significant new uses EPA has identified in this unit are uses 
that EPA believes are not ongoing at the time of this proposed rule. 
EPA is requesting public comment on this proposal, and specifically on 
the Agency's understanding of ongoing uses for the chemicals 
identified. EPA would welcome specific documentation of any ongoing 
uses.
    This proposed SNUR would require persons that intend to manufacture 
(including import) or process any of these chemicals for a significant 
new use, consistent with the requirements at 40 CFR 721.25, to notify 
EPA at least 90 days before commencing such manufacture or processing. 
This proposed SNUR would furthermore preclude the commencement of such 
manufacturing or processing 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.

D. Why is the agency taking this action?

    This proposed SNUR is necessary to ensure that EPA receives timely 
advance notice of any future manufacturing or processing of NEP and 
NiPP for new uses that may produce changes in human and environmental 
exposures, and to ensure that an appropriate determination (relevant to 
the risks of such manufacturing or processing) has been issued prior to 
the commencement of such manufacturing or processing. Today's action is 
furthermore necessary to ensure that, in the event that EPA determines: 
(1) That the significant new use presents an unreasonable risk under 
the conditions of use (without consideration of costs or other nonrisk 
factors, and including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by EPA); (2) that the 
information available to EPA is insufficient to permit a reasoned 
evaluation of the health and environmental effects of the significant 
new use; (3) that in the absence of sufficient information, the 
manufacture, processing, distribution in commerce, use, or disposal of 
the substance, or any combination of such activities, may present an 
unreasonable risk (without consideration of costs or other nonrisk 
factors, and including an unreasonable risk to a potentially exposed or 
susceptible subpopulation identified as relevant by EPA), or (4) that 
there is sufficient potential for environmental release or human 
exposure (as defined in TSCA section 5(a)(3)(B)(ii)(II)), then 
manufacturing or processing for the significant new use cannot proceed 
until EPA has responded to the circumstances by taking the required 
actions under sections 5(e) or 5(f) of TSCA.
    The two chemical substances subject to this proposed SNUR are 
structurally similar to and have similar physical-chemical properties 
to N-methylpyrrolidone (NMP), which EPA identified for risk evaluation 
as part of its Work Plan for Chemical Assessment under TSCA. Because of 
structural and physical-chemical similarity to NMP (Ref. 1, 2), these 
chemicals are expected to exhibit toxicity similar to NMP. The 
rationale and objectives for this proposed SNUR are explained in Unit 
III.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substances included in this proposed rule. This analysis 
(Ref. 3), which is available in the docket, is discussed in Unit IX., 
and is briefly summarized here.
    In the event that a SNUN is submitted, costs are estimated to be 
less than $8,900 per SNUN submission for large business submitters and 
$6,500 for small business submitters. These estimates include the cost 
to prepare and submit the SNUN and the payment of a user fee. The 
proposed SNUR would require first-time submitters of any TSCA section 5 
notice to register their company and key users with the CDX reporting 
tool, deliver a CDX electronic signature to EPA, and establish and use 
a Pay.gov E-payment account before they may submit a SNUN, for a cost 
of approximately $200 per firm. However, these activities are only 
required of first time submitters of section 5 notices. In addition, 
for persons exporting a substance that is the subject of a SNUR, a one-
time notice to EPA must be provided for the first export or intended 
export to a particular country, which is estimated to be approximately 
$80 per notification.

II. Chemical Substances Subject to This Proposed Rule

A. What chemicals are included in the proposed SNUR?

    This proposed SNUR would apply to two alkylpyrrolidones: NiPP 
(Chemical Abstract Services Registry Number (CASRN) 3772-26-7) for any 
use, and to NEP (CASRN 2687-91-4) for any use except for the ongoing 
uses as a reactant, in silicone seal remover, coatings, consumer and 
commercial paint primer, and adhesives.

B. What are the production volumes and uses of NEP and NiPP?

    In order to identify production volumes and uses of NEP and NiPP, 
EPA reviewed published literature including IHS' Chemical Economics 
Handbook, National Institute of Health's (NIH) Household Product 
Database, EPA's Chemical/Product Categorical Data (CPcat) database, the 
Consumer Product Information Database, the most recent data available 
from EPA's Chemical Data Reporting (CDR) program, general Google.com 
searches, Safety Data Sheets (SDSs), European Chemical Agency (ECHA) 
reports and risk assessments, the Danish Ministry of the Environment 
Surveys of Chemicals in Consumer Products, and other information from 
manufacturing company Web sites (Ref. 3). NEP has a wide variety of 
potential applications as a chemical intermediate in cosmetics, paints 
and printing inks, paint strippers, pharmaceuticals, adhesives and 
cleaners for polymeric residue (Ref. 4), in adhesives and reprographic 
agents (Ref. 5), and as a replacement for NMP in coating and cleaning 
applications (Ref. 6). Many of these potential uses have not been 
identified by EPA to occur domestically. Four companies, including 
domestic manufacturers and importers, reported production of NEP 
between 1,000,000 to 10,000,000 million pounds to the 2012 CDR database 
(Ref. 7). The uses reported to CDR for NEP include industrial solvent 
and reactant uses in pharmaceuticals, paints and coatings, adhesives, 
textiles, and print ink manufacturing. EPA was able to identify several 
U.S. products containing NEP including silicone seal remover, coatings, 
consumer and commercial paint primer, and adhesives. Based on this 
available product data, EPA believes that the ongoing uses of NEP can 
be described as ``use as a reactant, in silicone seal remover, 
coatings, consumer and commercial paint primer, and adhesives.''
    There are no known ongoing uses of NiPP as of November 17, 2016, 
the date of public release/web posting of this proposal.

C. What are the potential health effects of NEP and NiPP?

    NEP is an organic solvent used as a substitute for NMP because of 
its similar solvent properties and very similar chemical structure 
(Ref. 1). NiPP is also a structurally similar analog with physical-
chemical properties similar to NMP (Ref. 2). These two chemical

[[Page 85474]]

substances, like NMP, are pyrrolidones with alkyl groups, but with two 
or three carbons in the carbon chain on the nitrogen, whereas NMP has a 
methyl group (one carbon) on the nitrogen. Because of their similar 
structure and physical-chemical properties, NEP has been shown (Ref. 1) 
to, and NiPP is expected to, exhibit toxicity similar to NMP.
    EPA has identified developmental effects as a key endpoint of 
concern from NMP exposure. Specifically, EPA has identified a number of 
biologically relevant, consistent, and sensitive developmental effects 
due to exposure to NMP through the oral and dermal routes, including 
decreased fetal and pup body weight, delayed ossification, skeletal 
malformations, and increased fetal and pup mortality (Ref. 8, 9, 10).
    Study data are available on NEP and the developmental effects and 
malformations observed in the animal studies of NEP are similar to 
those observed in NMP studies (Ref. 1). For example, NEP exposure 
through oral and dermal routes is associated with adverse effects on 
fetal body weight, post-implantation loss (specifically late 
resorptions following oral exposures), and malformations. NEP exposure 
is also associated with skeletal malformations by oral route and 
cardiovascular malformation by oral and dermal routes in the animal 
studies (Ref. 1).

D. What are the potential routes and sources of exposure to NEP and 
NiPP?

    NMP is well absorbed following dermal exposures, such as during use 
of coating, paint stripping or cleaning products (Ref. 11, 12). Since 
NEP and NiPP are analogs of NMP, these chemical substances are expected 
to have similar routes of exposure. Dermal exposure and absorption, 
which includes dermal absorption from the vapor phase, typically 
contributes significantly to human exposure. Prolonged exposures to 
neat (i.e., pure) NMP increase the permeability of the skin. NMP is 
also absorbed via inhalation but the low vapor pressure and mild 
volatility can limit the amount of NMP available for inhalation.
    Given the similarity of their physical-chemical properties to those 
of NMP, NEP, and NiPP can be used in ways similar to NMP resulting in 
potential dermal and inhalation exposures.

III. Rationale and Objectives

A. Rationale

    EPA is concerned about the potential for adverse health effects of 
NEP and NiPP based on data on the adverse health effects of NEP and 
because these chemicals are analogs of NMP that have similar physical-
chemical properties and are therefore expected to or have been shown to 
have similar toxicological properties.
    As discussed in Unit II, based on an extensive review of available 
information, EPA has determined that, at the time of publication of 
this proposed rule NiPP is not used for any use, and that NEP has 
ongoing uses as a reactant, in silicone seal remover, coatings, 
consumer and commercial paint primer, and adhesives (Ref. 3). EPA has 
concluded that action on these chemical substances is warranted and 
therefore any manufacturing or processing of NiPP for any use, and 
manufacture or processing of NEP for any use except for the ongoing 
uses as a reactant, in silicone seal remover, coatings, consumer and 
commercial paint primer, and adhesives, would be a significant new use.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to propose a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. If a 
person decides to begin manufacturing or processing any of these 
chemicals for the use, the notice to EPA allows the Agency to evaluate 
the use according to the specific parameters and circumstances 
surrounding the conditions of use.

B. Objectives

    Based on the considerations in Unit III.A., EPA wants to achieve 
the following objectives with regard to the significant new use(s) of 
NEP and NiPP that are designated in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture 
or process the chemical substances for the described significant new 
use before that activity begins.
    2. EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing the chemical substances for the described significant new 
use.
    3. 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.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
    1. The projected volume of manufacturing and processing of a 
chemical substance.
    2. The extent to which a use changes the type or form of exposure 
of human beings or the environment to a chemical substance.
    3. The extent to which a use increases the magnitude and duration 
of exposure of human beings or the environment to a chemical substance.
    4. 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 authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of NEP or 
NiPP, as discussed in this unit, EPA considered relevant information 
about the toxicity or expected toxicity of these substances, likely 
human exposures and environmental releases associated with possible 
uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has 
preliminarily determined as significant new uses: Any use of NiPP and 
any use of NEP except for the ongoing uses as a reactant, in silicone 
seal remover, coatings, consumer and commercial paint primer, and 
adhesives. Because NiPP is not used, and NEP is not currently used 
except as a reactant, in silicone seal remover, coatings, consumer and 
commercial paint primer, and adhesives, EPA believes any new use could 
increase the magnitude and duration of human exposure to these chemical 
substances. Exposure to NEP or NiPP may lead to adverse developmental 
health effects.

V. Applicability of General Provisions

    General provisions for SNURs appear under 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 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same notice requirements and EPA regulatory procedures as 
submitters of Premanufacture Notices (PMNs) under TSCA section 
5(a)(1)(A). In particular,

[[Page 85475]]

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 finding.
    Persons who export or intend to export a chemical substance 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. 
Persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements, 
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those 
persons must certify that the shipment of the chemical substance 
complies with all applicable rules and orders under TSCA, including any 
SNUR requirements. The EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B.

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

    EPA designates November 17, 2016 (the date of public release/web 
posting of this proposal) as the cutoff date for determining whether 
the new use is ongoing. This designation varies slightly from EPA's 
past practice of designating the date of Federal Register publication 
as the date for making this determination (Ref. 13). The objective of 
EPA's approach has been to ensure that a person could not defeat a SNUR 
by initiating a significant new use before the effective date of the 
final rule. In developing this proposal, EPA has recognized that, given 
EPA's practice of now posting proposed rules on its Web site a week or 
more in advance of Federal Register publication, this objective could 
be thwarted even before that publication. Thus, EPA has slightly 
modified its approach in this rulemaking and plans to follow this 
modified approach in future significant new use rulemakings. See the 
Federal Register of August 24, 2016, (81 FR 57846) (FRL-9951-06), (see 
page 57848).
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of November 
17, 2016 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 all TSCA prerequisites for the commencement of manufacture 
or processing have been satisfied. 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 usually require 
developing new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: Development of information 
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 section 4 test rule covering the chemical 
substance, persons are required to submit only information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 
40 CFR 720.50). However, as a general matter, EPA recommends that SNUN 
submitters include information that would permit a reasoned evaluation 
of risks posed by the chemical substance during its manufacture, 
processing, use, distribution in commerce, or disposal. EPA encourages 
persons to consult with the Agency before submitting a SNUN. As part of 
this optional pre-notice consultation, EPA would discuss specific 
information it believes may be useful in evaluating a significant new 
use.
    Submitting a SNUN that does not itself include information 
sufficient to permit a reasoned evaluation may increase the likelihood 
that EPA will either respond with a determination that the information 
available to the Agency is insufficient to permit a reasoned evaluation 
of the health and environmental effects of the significant new use or, 
alternatively, that in the absence of sufficient information, the 
manufacture, processing, distribution in commerce, use, or disposal of 
the chemical substance may present an unreasonable risk of injury.
    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 human 
exposure and environmental releases that may result from the 
significant new uses of the chemical substance.

VIII. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to 
submitting a SNUN to discuss what information may be useful in 
evaluating a significant new use. Discussions with the Agency prior to 
submission can afford ample time to conduct any tests that might be 
helpful in evaluating risks posed by the substance. According 
to[emsp14]40 CFR 721.1(c), persons submitting a SNUN must comply with 
the same notice requirements and EPA regulatory procedures as persons 
submitting a PMN, including submission of test data on health and 
environmental effects as described in 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[emsp14]721.25 and 40 CFR 720.40. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substance included in this proposed rule (Ref. 3). In the 
event that a SNUN is submitted, costs are estimated at approximately 
$8,900 per SNUN submission for large business submitters and $6,500 for 
small business submitters. These estimates include the cost to prepare 
and submit the SNUN, and the payment of a user fee. Businesses that 
submit a SNUN would be subject to either a $2,500 user fee required by 
40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual 
sales of less than $40 million when combined with those of the parent 
company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). 
EPA's complete economic analysis is available in the public docket for 
this proposed rule (Ref. 3).

B. Export Notification

    Under section 12(b) of TSCA and the implementing regulations at 40 
CFR part 707, subpart D, exporters must notify EPA if they export or 
intend to export

[[Page 85476]]

a chemical substance or mixture for which, among other things, a rule 
has been proposed or promulgated under TSCA section 5. For persons 
exporting a substance that is the subject of a SNUR, a one-time notice 
to EPA must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical, depending on the number of required notifications (i.e., the 
number of countries to which the chemical is exported). While EPA is 
unable to make any estimate of the likely number of export 
notifications for the chemical covered in this proposed SNUR, as stated 
in the accompanying economic analysis of this proposed SNUR, the 
estimated cost of the export notification requirement on a per unit 
basis is $83.

X. Alternatives

    Before proposing this SNUR, EPA considered the following 
alternative regulatory action: Promulgate a TSCA Section 8(a) Reporting 
Rule.
    Under a TSCA section 8(a) rule, EPA could, among other things, 
generally require persons to report information to the Agency when they 
intend to manufacture or process a listed chemical for a specific use 
or any use. However, for NEP and NiPP, the use of TSCA section 8(a) 
rather than SNUR authority would have several limitations. First, if 
EPA were to require reporting under TSCA section 8(a) instead of TSCA 
section 5(a), that action would not ensure that EPA receives timely 
advance notice of any future manufacturing or processing of NEP and 
NiPP for new uses that may produce changes in human and environmental 
exposures. Nor would it ensure that an appropriate determination 
(relevant to the risks of such manufacturing or processing) has been 
issued prior to the commencement of such manufacturing or processing. 
Furthermore, a TSCA section 8(a) rule would not ensure that, in the 
event that EPA determines: (1) That the significant new use presents an 
unreasonable risk under the conditions of use (without consideration of 
costs or other nonrisk factors, and including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
by EPA); (2) that the information available to EPA is insufficient to 
permit a reasoned evaluation of the health and environmental effects of 
the significant new use; (3) that in the absence of sufficient 
information, the manufacture, processing, distribution in commerce, 
use, or disposal of the substance, or any combination of such 
activities, may present an unreasonable risk (without consideration of 
costs or other nonrisk factors, and including an unreasonable risk to a 
potentially exposed or susceptible subpopulation identified as relevant 
by EPA), or (4) that there is sufficient potential for environmental 
release or human exposure (as defined in TSCA section 
5(a)(3)(B)(ii)(II)), then manufacturing or processing for the 
significant new use cannot proceed until EPA has responded to the 
circumstances by taking the required actions under sections 5(e) or 
5(f) of TSCA.
    In addition, EPA may not receive important information from small 
businesses, because such firms generally are exempt from TSCA section 
8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 
8(a)(1)(B)). In view of the level of health concerns about NEP and NiPP 
if used for a proposed significant new use, EPA believes that a TSCA 
section 8(a) rule for this substance would not meet EPA's regulatory 
objectives.

XI. Scientific Standards, Evidence, and Available Information

    EPA has used scientific information, technical procedures, 
measures, methods, protocols, methodologies, and models consistent with 
the best available science, as applicable. 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). As noted in Unit III, EPA's decision to 
propose a SNUR for a particular chemical use need not be based on an 
extensive evaluation of the hazard, exposure, or potential risk 
associated with that use.
    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 
references 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

XII. Request for Comment

A. Do you have comments or information about ongoing uses?

    EPA welcomes comment on all aspects of this proposed rule. EPA 
based its understanding of the use profile of these chemicals on the 
published literature, the 2012 Chemical Data Reporting submissions, 
market research, and review of Safety Data Sheets. To confirm EPA's 
understanding, the Agency is requesting public comment on all aspects 
of this proposed rule, including EPA's understanding that NiPP is not 
currently used, and NEP is not used except as a reactant, in silicone 
seal remover, coatings, consumer and commercial paint primer, and 
adhesives. In providing comments on an ongoing use of NEP and NiPP, it 
would be helpful if you provide sufficient information for EPA to 
substantiate any assertions of use. EPA does not have specific 
information on the concentration by weight of NEP currently being used 
in silicone seal remover, coatings, consumer and commercial paint 
primer, and adhesives. If this information were available, EPA could 
better characterize the use. As such, EPA requests comment on the 
concentration by weight of NEP currently being used in silicone seal 
remover, coatings, consumer and commercial paint primer, and adhesives.

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

    1. Submitting CBI. It is EPA's policy to include all comments 
received in the public docket without change or further notice to the 
commenter and to make the comments available on-line at 
www.regulations.gov, including any personal information provided, 
unless a comment includes information claimed to be CBI or other 
information whose disclosure is restricted by statute. 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 that you mail to EPA 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

[[Page 85477]]

accordance with procedures set forth in 40 CFR part 2, subpart B.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www2.epa.gov/dockets/commenting-epa-dockets#tips.

XIII. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. ECHA, Committee for Risk Assessment. Annex 1 Background 
document to the Opinion proposing harmonised classification and 
labelling at Community level of N-ethyl-2-pyrrolidone (NEP). ECHA/
RAC/CLH-O-0000002192-83-01/A1. 2011.
    2. Vandeputte, Bart; Moonen, Kristof; and Roose, Peter. Use of 
improved N-alkyl pyrrolidone solvents. Google Patents. Publication 
Number: US20150057375 A1. Filing Date: January 17, 2013. Publication 
Date: February 26, 2015. Available at http://www.google.com/patents/WO2013107822A1?cl=en.
    3. EPA. Economic Analysis of the Proposed Significant New Use 
Rule for Alkylpyrrolidones. March 31, 2016.
    4. BASF. N-Ethylpyrrolidone-2 (NEP) Technical Data Sheet. July 
2009. Available at http://worldaccount.basf.com/wa/NAFTA~es_MX/
Catalog/ChemicalsNAFTA/doc4/BASF/PRD/
30036616/.pdf?urn=urn:documentum:eCommerce_sol_EU:09007bb280065a74.pd
f.
    5. EPA. Chemical and Product Categories (CPCat) Database. 
Accessed September 2015. Available at http://actor.epa.gov/cpcat/faces/home.xhtml.
    6. BASF Corp Germany. N-Ethylpyrrolidone. Accessed August 2016. 
Available at https://www.standort-ludwigshafen.basf.de/group/corporate/site-ludwigshafen/en/brand/N_ETHYLPYRROLIDONE.
    7. EPA. Downloadable of the Non-Confidential Chemical Reporting 
Data (CDR) Database. Downloaded July 2014.
    8. Sitarek, K., J. Stekiewicz, and W. Wasowicz. 2012. Evaluation 
of Reproductive Disorders in Female Rats Exposed to N-Methyl-2-
Pyrrolidone. Birth Defects Research (Part B), 95, 195-201.
    9. Saillenfait, A. M., F. Gallissot, I. Langonne, and J. P. 
Sabate. 2002. Developmental Toxicity of NMethyl-2-Pyrrolidone 
Administered Orally to Rats. Food Chemistry and Toxicology, 40(11), 
1705-1712.
    10. Hass, U., S. P. Lund, and J. Elsner. 1994. Effects of 
Prenatal Exposure to N-Methylpyrrolidone on Postnatal Development 
and Behavior in Rats. Neurotoxicology and Teratology, 16(3), 241-
249.
    11. Bader, M., R. Wrbitzky, M. Blaszkewicz, M. Schaper, and C. 
van Thriel. 2008. Human Volunteer Study on the Inhalational and 
Dermal Absorption of N-Methyl-2-Pyrrolidone (NMP) from the Vapour 
Phase. Archives of Toxicology, 82(1), 13-20.
    12. Keener, S., R. Wrbitzky, and M. Bader. 2007. Human Volunteer 
Study on the Influence of Exposure Dilution of Dermally Applied N-
Methyl-2-Pyrrolidone (NMP) on the Urinary Elimination of NMP 
Metabolites. International Archives of Occupational and 
Environmental Health, 80(4), 327-334.
    13. EPA. Significant New Uses of Certain Chemical Substances; 
Final Rule. RIVM, 2013). Federal Register (April 24, 1990, 55 FR 
17376) (FRL-3658-5).

XIV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This proposed SNUR is not a ``significant regulatory action'' and 
was therefore not submitted to the Office of Management and Budget 
(OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 
1993) and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with 
existing chemical SNURs are already approved under OMB control number 
2070-0038 (EPA ICR No. 1188); and the information collection activities 
associated with export notifications are already approved under OMB 
control number 2070-0030 (EPA ICR No. 0795). If an entity were to 
submit a SNUN to the Agency, the annual burden is estimated to be less 
than 100 hours per response, and the estimated burden for export 
notifications is less than 1.5 hours per notification. In both cases, 
burden is estimated to be reduced for submitters who have already 
registered to use the electronic submission system.
    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 the 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, as applicable.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
certify that promulgation of this SNUR would not have a significant 
economic impact on a substantial number of small entities. The 
rationale supporting this conclusion is as follows.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the rule as a 
``significant new use.'' By definition of the word ``new'' and based on 
all information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. Since this SNUR 
will require a person who intends to engage in such activity in the 
future to first notify EPA by submitting a SNUN, no economic impact 
will occur unless someone files a SNUN to pursue a significant new use 
in the future or forgoes profits by avoiding or delaying the 
significant new use. Although some small entities may decide to conduct 
such activities in the future, EPA cannot presently determine how many, 
if any, there may be. However, EPA's experience to date is that, in 
response to the promulgation of SNURs covering over 1,000 chemical 
substances, the Agency receives only a handful of notices per year. 
During the six year period from 2005-2010, only three submitters self-
identified as small in their SNUN submission (Ref. 3). EPA believes the 
cost of submitting a SNUN is relatively small compared to the cost of 
developing and marketing a chemical new to a firm or marketing a new 
use of the chemical and that the requirement to submit a SNUN generally 
does not have a significant economic impact.
    Therefore, EPA believes that the potential economic impact of 
complying with this proposed SNUR is not expected to be significant or 
adversely impact a substantial number of small entities. In a SNUR that 
published as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), 
the Agency presented its general determination that proposed and final 
SNURs are not expected to 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 reason to

[[Page 85478]]

believe that any State, local, or Tribal government would be impacted 
by this rulemaking. As such, the requirements of sections 202, 203, 
204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.

E. Executive Order 13132: Federalism

    This action will not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have 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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have any effect on tribal governments, on the relationship between 
the Federal Government and the Indian tribes, or on the distribution of 
power and responsibilities between the Federal Government and Indian 
tribes.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this action does not address environmental 
health or safety risks, and EPA interprets Executive Order 13045 as 
applying only to those regulatory actions that concern environmental 
health or safety risks that EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not 
likely to have any effect on energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve any technical standards, and is 
therefore not subject to considerations under section 12(d) of NTTAA, 
15 U.S.C.272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations 
as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). 
This action does not affect the level of protection provided to human 
health or the environment.

List of Subjects in 40 CFR Part 721

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

    Dated: November 14, 2016.
Jeffery T. Morris,
Acting Director, 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.  721.10925 to subpart E to read as follows:


Sec.  721.10925  Alkylpyrrolidones.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances N-ethylpyrrolidone (CASRN 2687-
91-4) and N-isopropylpyrrolidone (CASRN 3772-26-7) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) For N-ethylpyrrolidone (CASRN 2687-91-4), any use except for 
use as reactant and in silicone seal remover, coatings, consumer and 
commercial paint primer, and adhesives.
    (ii) For N-isopropylpyrrolidone (CASRN 3772-26-7), any use.
    (b) [Reserved]

[FR Doc. 2016-28565 Filed 11-25-16; 8:45 am]
 BILLING CODE 6560-50-P



                                                    85472                Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules

                                                    ENVIRONMENTAL PROTECTION                                dockets generally, is available at http://            any chemical substance governed by a
                                                    AGENCY                                                  www.epa.gov/dockets.                                  final SNUR are subject to the TSCA
                                                                                                            FOR FURTHER INFORMATION CONTACT: For                  section 13 (15 U.S.C. 2612) import
                                                    40 CFR Part 721                                         technical information contact: Tyler                  certification requirements and the
                                                                                                            Lloyd, Chemical Control Division                      corresponding regulations at 19 CFR
                                                    [EPA–HQ–OPPT–2015–0387; FRL–9945–53]                                                                          12.118 through 12.127; see also 19 CFR
                                                                                                            (7405M), Office of Pollution Prevention
                                                    RIN 2070–AK09                                           and Toxics, Environmental Protection                  127.28. Those persons must certify that
                                                                                                            Agency, 1200 Pennsylvania Ave. NW.,                   the shipment of the chemical substance
                                                    Alkylpyrrolidones; Significant New Use                  Washington, DC 20460–0001; telephone                  complies with all applicable rules and
                                                    Rule                                                    number: (202) 564–4016; email address:                orders under TSCA, including any
                                                                                                            lloyd.tyler@epa.gov.                                  SNUR requirements. The EPA policy in
                                                    AGENCY:  Environmental Protection                          For general information contact: The               support of import certification appears
                                                    Agency (EPA).                                           TSCA-Hotline, ABVI-Goodwill, 422                      at 40 CFR part 707, subpart B. In
                                                    ACTION: Proposed rule.                                  South Clinton Ave., Rochester, NY                     addition, any persons who export or
                                                                                                            14620; telephone number: (202) 554–                   intend to export a chemical substance
                                                    SUMMARY:   Under the Toxic Substance                                                                          that is the subject of this proposed rule
                                                                                                            1404; email address: TSCA-Hotline@
                                                    Control Act (TSCA), EPA is proposing a                                                                        on or after December 28, 2016 are
                                                                                                            epa.gov.
                                                    significant new use rule (SNUR) for two                                                                       subject to the export notification
                                                    alkylpyrrolidones: N-ethylpyrrolidone                   SUPPLEMENTARY INFORMATION:                            provisions of TSCA section 12(b) (15
                                                    (NEP) and N-isopropylpyrrolidone                        I. General Information                                U.S.C. 2611(b)), (see 40 CFR 721.20),
                                                    (NiPP). The proposed significant new                                                                          and must comply with the export
                                                    uses are any use of NiPP and any use                    A. Does this action apply to me?                      notification requirements in 40 CFR part
                                                    of NEP except for the ongoing uses as                      You may be potentially affected by                 707, subpart D.
                                                    a reactant, in silicone seal remover,                   this action if you manufacture, process,                 If you have any questions regarding
                                                    coatings, consumer and commercial                       or distribute in commerce chemical                    the applicability of this action to a
                                                    paint primer, and adhesives. Persons                    substances and mixtures. The following                particular entity, consult the technical
                                                    subject to the SNUR would be required                   list of North American Industrial                     information contact listed under FOR
                                                    to notify EPA at least 90 days before                   Classification System (NAICS) codes is                FURTHER INFORMATION CONTACT.
                                                    commencing any manufacturing or                         not intended to be exhaustive, but rather             B. What Is the Agency’s authority for
                                                    processing of the chemical substance for                provides a guide to help readers                      taking this action?
                                                    a significant new use. The required                     determine whether this document
                                                    notification initiates EPA’s evaluation of              applies to them. Potentially affected                    Section 5(a)(2) of TSCA (15 U.S.C.
                                                    the conditions of use within the                        entities may include:                                 2604(a)(2)) authorizes EPA to determine
                                                    applicable review period. Manufacture                      • Ship Building and Repairing                      that a use of a chemical substance is a
                                                    and processing for the significant new                  (NAICS code 336611).                                  ‘‘significant new use.’’ EPA must make
                                                    use is unable to commence until EPA                        • Aircraft Manufacturing (NAICS                    this determination by rule after
                                                    has conducted a review of the notice,                   code 336411).                                         considering all relevant factors,
                                                    made an appropriate determination on                       • Museums (NAICS code 712110).                     including those listed in TSCA section
                                                    the notice, and taken such actions as are                  • Independent Artists, Writers, and                5(a)(2) (see Unit IV.). Once EPA
                                                    required in association with that                       Performers (NAICS code 711510).                       determines that a use of a chemical
                                                    determination.                                             • Reupholster and Furniture Repair                 substance is a significant new use,
                                                                                                            (NAICS code 811420).                                  TSCA section 5(a)(1) requires persons to
                                                    DATES:  Comments must be received on
                                                    or before January 27, 2017.                                • Automotive Body Paint and Interior               submit a significant new use notice
                                                                                                            Repair Maintenance (NAICS code                        (SNUN) to EPA at least 90 days before
                                                    ADDRESSES: Submit your comments,                                                                              they manufacture (including import) or
                                                                                                            811121).
                                                    identified by docket identification (ID)                   • Flooring Contractors (NAICS code                 process the chemical substance for that
                                                    number EPA–HQ–OPPT–2015–0387, by                        238330).                                              use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA
                                                    one of the following methods:                              • Painting and Wall Covering                       furthermore prohibits such
                                                      • Federal eRulemaking Portal: http://                 Contractors (NAICS code 238320).                      manufacturing or processing from
                                                    www.regulations.gov. Follow the online                     • Adhesive Tape Manufacturing                      commencing until EPA has conducted a
                                                    instructions for submitting comments.                   (NAICS code 339113).                                  review of the notice, made an
                                                    Do not submit electronically any                           • Adhesive Manufacturing (NAICS                    appropriate determination on the notice,
                                                    information you consider to be                          code 325520).                                         and taken such actions as are required
                                                    Confidential Business Information (CBI)                    • Denture Adhesive Manufacturing                   in association with that determination
                                                    or other information whose disclosure is                (NAICS code 325620).                                  (15 U.S.C. 2604(a)(1)(B)(ii)). As
                                                    restricted by statute.                                     • Basic Chemical Manufacturing                     described in Unit V., the general SNUR
                                                      • Mail: Document Control Office                       (NAICS code 325411).                                  provisions are found at 40 CFR part 721,
                                                    (7407M), Office of Pollution Prevention                    • Pharmaceutical and Medicine                      subpart A.
                                                    and Toxics (OPPT), Environmental                        Manufacturing (NAICS code 32541).
                                                    Protection Agency, 1200 Pennsylvania                       • Printing Ink Manufacturing (NAICS                C. What action is the agency taking?
                                                    Ave. NW., Washington, DC 20460–0001.                    code 325910).                                            EPA is proposing a SNUR for two
mstockstill on DSK3G9T082PROD with PROPOSALS




                                                      • Hand Delivery: To make special                         • Textile Leather Manufacturing                    alkylpyrrolidones: N-ethylpyrrolidone
                                                    arrangements for hand delivery or                       (NAICS code 316998).                                  (NEP) and N-isopropylpyrrolidone
                                                    delivery of boxed information, please                      • Textile Manufacturing (NAICS code                (NiPP). The proposed significant new
                                                    follow the instructions at http://                      325613).                                              uses are any use of NiPP and any use
                                                    www.epa.gov/dockets/contacts.html.                         This action may also affect certain                of NEP except for the ongoing uses as
                                                      Additional instructions on                            entities through pre-existing import                  a reactant, in silicone seal remover,
                                                    commenting or visiting the docket,                      certification and export notification                 coatings, consumer and commercial
                                                    along with more information about                       rules under TSCA. Persons who import                  paint primer, and adhesives. The


                                               VerDate Sep<11>2014   16:30 Nov 25, 2016   Jkt 241001   PO 00000   Frm 00025   Fmt 4702   Sfmt 4702   E:\FR\FM\28NOP1.SGM   28NOP1


                                                                         Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules                                           85473

                                                    proposed significant new uses EPA has                   until EPA has responded to the                        coatings, consumer and commercial
                                                    identified in this unit are uses that EPA               circumstances by taking the required                  paint primer, and adhesives.
                                                    believes are not ongoing at the time of                 actions under sections 5(e) or 5(f) of
                                                                                                                                                                  B. What are the production volumes and
                                                    this proposed rule. EPA is requesting                   TSCA.
                                                                                                                                                                  uses of NEP and NiPP?
                                                    public comment on this proposal, and                       The two chemical substances subject
                                                    specifically on the Agency’s                                                                                     In order to identify production
                                                                                                            to this proposed SNUR are structurally
                                                    understanding of ongoing uses for the                                                                         volumes and uses of NEP and NiPP,
                                                                                                            similar to and have similar physical-
                                                    chemicals identified. EPA would                                                                               EPA reviewed published literature
                                                                                                            chemical properties to N-
                                                    welcome specific documentation of any                                                                         including IHS’ Chemical Economics
                                                                                                            methylpyrrolidone (NMP), which EPA
                                                    ongoing uses.                                                                                                 Handbook, National Institute of Health’s
                                                                                                            identified for risk evaluation as part of
                                                       This proposed SNUR would require                                                                           (NIH) Household Product Database,
                                                                                                            its Work Plan for Chemical Assessment
                                                    persons that intend to manufacture                                                                            EPA’s Chemical/Product Categorical
                                                                                                            under TSCA. Because of structural and
                                                    (including import) or process any of                                                                          Data (CPcat) database, the Consumer
                                                                                                            physical-chemical similarity to NMP
                                                    these chemicals for a significant new                                                                         Product Information Database, the most
                                                                                                            (Ref. 1, 2), these chemicals are expected
                                                    use, consistent with the requirements at                                                                      recent data available from EPA’s
                                                                                                            to exhibit toxicity similar to NMP. The               Chemical Data Reporting (CDR)
                                                    40 CFR 721.25, to notify EPA at least 90                rationale and objectives for this
                                                    days before commencing such                                                                                   program, general Google.com searches,
                                                                                                            proposed SNUR are explained in Unit                   Safety Data Sheets (SDSs), European
                                                    manufacture or processing. This
                                                                                                            III.                                                  Chemical Agency (ECHA) reports and
                                                    proposed SNUR would furthermore
                                                    preclude the commencement of such                       E. What are the estimated incremental                 risk assessments, the Danish Ministry of
                                                    manufacturing or processing until EPA                   impacts of this action?                               the Environment Surveys of Chemicals
                                                    has conducted a review of the notice,                                                                         in Consumer Products, and other
                                                    made an appropriate determination on                      EPA has evaluated the potential costs               information from manufacturing
                                                    the notice, and taken such actions as are               of establishing SNUR reporting                        company Web sites (Ref. 3). NEP has a
                                                    required in association with that                       requirements for potential                            wide variety of potential applications as
                                                    determination.                                          manufacturers and processors of the                   a chemical intermediate in cosmetics,
                                                                                                            chemical substances included in this                  paints and printing inks, paint strippers,
                                                    D. Why is the agency taking this action?                proposed rule. This analysis (Ref. 3),                pharmaceuticals, adhesives and cleaners
                                                       This proposed SNUR is necessary to                   which is available in the docket, is                  for polymeric residue (Ref. 4), in
                                                    ensure that EPA receives timely advance                 discussed in Unit IX., and is briefly                 adhesives and reprographic agents (Ref.
                                                    notice of any future manufacturing or                   summarized here.                                      5), and as a replacement for NMP in
                                                    processing of NEP and NiPP for new                        In the event that a SNUN is                         coating and cleaning applications (Ref.
                                                    uses that may produce changes in                        submitted, costs are estimated to be less             6). Many of these potential uses have
                                                    human and environmental exposures,                      than $8,900 per SNUN submission for                   not been identified by EPA to occur
                                                    and to ensure that an appropriate                       large business submitters and $6,500 for              domestically. Four companies,
                                                    determination (relevant to the risks of                 small business submitters. These                      including domestic manufacturers and
                                                    such manufacturing or processing) has                   estimates include the cost to prepare                 importers, reported production of NEP
                                                    been issued prior to the commencement                   and submit the SNUN and the payment                   between 1,000,000 to 10,000,000 million
                                                    of such manufacturing or processing.                    of a user fee. The proposed SNUR                      pounds to the 2012 CDR database (Ref.
                                                    Today’s action is furthermore necessary                 would require first-time submitters of                7). The uses reported to CDR for NEP
                                                    to ensure that, in the event that EPA                   any TSCA section 5 notice to register                 include industrial solvent and reactant
                                                    determines: (1) That the significant new                their company and key users with the                  uses in pharmaceuticals, paints and
                                                    use presents an unreasonable risk under                 CDX reporting tool, deliver a CDX                     coatings, adhesives, textiles, and print
                                                    the conditions of use (without                          electronic signature to EPA, and                      ink manufacturing. EPA was able to
                                                    consideration of costs or other nonrisk                 establish and use a Pay.gov E-payment                 identify several U.S. products
                                                    factors, and including an unreasonable                  account before they may submit a                      containing NEP including silicone seal
                                                    risk to a potentially exposed or                        SNUN, for a cost of approximately $200                remover, coatings, consumer and
                                                    susceptible subpopulation identified as                 per firm. However, these activities are               commercial paint primer, and
                                                    relevant by EPA); (2) that the                          only required of first time submitters of             adhesives. Based on this available
                                                    information available to EPA is                         section 5 notices. In addition, for                   product data, EPA believes that the
                                                    insufficient to permit a reasoned                       persons exporting a substance that is the             ongoing uses of NEP can be described as
                                                    evaluation of the health and                            subject of a SNUR, a one-time notice to               ‘‘use as a reactant, in silicone seal
                                                    environmental effects of the significant                EPA must be provided for the first                    remover, coatings, consumer and
                                                    new use; (3) that in the absence of                     export or intended export to a particular             commercial paint primer, and
                                                    sufficient information, the manufacture,                country, which is estimated to be                     adhesives.’’
                                                    processing, distribution in commerce,                   approximately $80 per notification.                      There are no known ongoing uses of
                                                    use, or disposal of the substance, or any                                                                     NiPP as of November 17, 2016, the date
                                                    combination of such activities, may                     II. Chemical Substances Subject to This               of public release/web posting of this
                                                    present an unreasonable risk (without                   Proposed Rule                                         proposal.
                                                    consideration of costs or other nonrisk                 A. What chemicals are included in the
                                                    factors, and including an unreasonable                                                                        C. What are the potential health effects
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                                                                                                            proposed SNUR?                                        of NEP and NiPP?
                                                    risk to a potentially exposed or
                                                    susceptible subpopulation identified as                   This proposed SNUR would apply to                      NEP is an organic solvent used as a
                                                    relevant by EPA), or (4) that there is                  two alkylpyrrolidones: NiPP (Chemical                 substitute for NMP because of its similar
                                                    sufficient potential for environmental                  Abstract Services Registry Number                     solvent properties and very similar
                                                    release or human exposure (as defined                   (CASRN) 3772–26–7) for any use, and to                chemical structure (Ref. 1). NiPP is also
                                                    in TSCA section 5(a)(3)(B)(ii)(II)), then               NEP (CASRN 2687–91–4) for any use                     a structurally similar analog with
                                                    manufacturing or processing for the                     except for the ongoing uses as a                      physical-chemical properties similar to
                                                    significant new use cannot proceed                      reactant, in silicone seal remover,                   NMP (Ref. 2). These two chemical


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                                                    85474                Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules

                                                    substances, like NMP, are pyrrolidones                  health effects of NEP and because these               IV. Significant New Use Determination
                                                    with alkyl groups, but with two or three                chemicals are analogs of NMP that have                   Section 5(a)(2) of TSCA states that
                                                    carbons in the carbon chain on the                      similar physical-chemical properties                  EPA’s determination that a use of a
                                                    nitrogen, whereas NMP has a methyl                      and are therefore expected to or have                 chemical substance is a significant new
                                                    group (one carbon) on the nitrogen.                     been shown to have similar                            use must be made after consideration of
                                                    Because of their similar structure and                  toxicological properties.                             all relevant factors including:
                                                    physical-chemical properties, NEP has                      As discussed in Unit II, based on an                  1. The projected volume of
                                                    been shown (Ref. 1) to, and NiPP is                     extensive review of available                         manufacturing and processing of a
                                                    expected to, exhibit toxicity similar to                information, EPA has determined that,                 chemical substance.
                                                    NMP.                                                    at the time of publication of this                       2. The extent to which a use changes
                                                       EPA has identified developmental                     proposed rule NiPP is not used for any                the type or form of exposure of human
                                                    effects as a key endpoint of concern                    use, and that NEP has ongoing uses as                 beings or the environment to a chemical
                                                    from NMP exposure. Specifically, EPA                    a reactant, in silicone seal remover,                 substance.
                                                    has identified a number of biologically                 coatings, consumer and commercial                        3. The extent to which a use increases
                                                    relevant, consistent, and sensitive                     paint primer, and adhesives (Ref. 3).                 the magnitude and duration of exposure
                                                    developmental effects due to exposure                   EPA has concluded that action on these                of human beings or the environment to
                                                    to NMP through the oral and dermal                      chemical substances is warranted and                  a chemical substance.
                                                    routes, including decreased fetal and                   therefore any manufacturing or                           4. The reasonably anticipated manner
                                                    pup body weight, delayed ossification,                  processing of NiPP for any use, and                   and methods of manufacturing,
                                                    skeletal malformations, and increased                   manufacture or processing of NEP for                  processing, distribution in commerce,
                                                    fetal and pup mortality (Ref. 8, 9, 10).                any use except for the ongoing uses as                and disposal of a chemical substance.
                                                       Study data are available on NEP and                  a reactant, in silicone seal remover,                    In addition to these factors
                                                    the developmental effects and                           coatings, consumer and commercial                     enumerated in TSCA section 5(a)(2), the
                                                    malformations observed in the animal                    paint primer, and adhesives, would be                 statute authorizes EPA to consider any
                                                    studies of NEP are similar to those                     a significant new use.                                other relevant factors.
                                                    observed in NMP studies (Ref. 1). For                                                                            To determine what would constitute a
                                                                                                               Consistent with EPA’s past practice
                                                    example, NEP exposure through oral                                                                            significant new use of NEP or NiPP, as
                                                                                                            for issuing SNURs under TSCA section
                                                    and dermal routes is associated with                                                                          discussed in this unit, EPA considered
                                                                                                            5(a)(2), EPA’s decision to propose a
                                                    adverse effects on fetal body weight,                                                                         relevant information about the toxicity
                                                                                                            SNUR for a particular chemical use
                                                    post-implantation loss (specifically late                                                                     or expected toxicity of these substances,
                                                                                                            need not be based on an extensive
                                                    resorptions following oral exposures),                                                                        likely human exposures and
                                                                                                            evaluation of the hazard, exposure, or
                                                    and malformations. NEP exposure is                                                                            environmental releases associated with
                                                                                                            potential risk associated with that use.
                                                    also associated with skeletal                                                                                 possible uses, and the four factors listed
                                                                                                            If a person decides to begin
                                                    malformations by oral route and                                                                               in section 5(a)(2) of TSCA. EPA has
                                                                                                            manufacturing or processing any of
                                                    cardiovascular malformation by oral and                                                                       preliminarily determined as significant
                                                                                                            these chemicals for the use, the notice
                                                    dermal routes in the animal studies (Ref.                                                                     new uses: Any use of NiPP and any use
                                                                                                            to EPA allows the Agency to evaluate
                                                    1).                                                                                                           of NEP except for the ongoing uses as
                                                                                                            the use according to the specific
                                                    D. What are the potential routes and                    parameters and circumstances                          a reactant, in silicone seal remover,
                                                    sources of exposure to NEP and NiPP?                    surrounding the conditions of use.                    coatings, consumer and commercial
                                                                                                                                                                  paint primer, and adhesives. Because
                                                      NMP is well absorbed following                        B. Objectives                                         NiPP is not used, and NEP is not
                                                    dermal exposures, such as during use of
                                                                                                               Based on the considerations in Unit                currently used except as a reactant, in
                                                    coating, paint stripping or cleaning
                                                                                                            III.A., EPA wants to achieve the                      silicone seal remover, coatings,
                                                    products (Ref. 11, 12). Since NEP and
                                                                                                            following objectives with regard to the               consumer and commercial paint primer,
                                                    NiPP are analogs of NMP, these
                                                                                                            significant new use(s) of NEP and NiPP                and adhesives, EPA believes any new
                                                    chemical substances are expected to
                                                                                                            that are designated in this proposed                  use could increase the magnitude and
                                                    have similar routes of exposure. Dermal
                                                                                                            rule:                                                 duration of human exposure to these
                                                    exposure and absorption, which
                                                                                                                                                                  chemical substances. Exposure to NEP
                                                    includes dermal absorption from the                        1. EPA would receive notice of any
                                                                                                                                                                  or NiPP may lead to adverse
                                                    vapor phase, typically contributes                      person’s intent to manufacture or
                                                                                                                                                                  developmental health effects.
                                                    significantly to human exposure.                        process the chemical substances for the
                                                    Prolonged exposures to neat (i.e., pure)                described significant new use before                  V. Applicability of General Provisions
                                                    NMP increase the permeability of the                    that activity begins.                                    General provisions for SNURs appear
                                                    skin. NMP is also absorbed via                             2. EPA would have an opportunity to                under 40 CFR part 721, subpart A.
                                                    inhalation but the low vapor pressure                   review and evaluate data submitted in a               These provisions describe persons
                                                    and mild volatility can limit the amount                SNUN before the notice submitter                      subject to the rule, recordkeeping
                                                    of NMP available for inhalation.                        begins manufacturing or processing the                requirements, exemptions to reporting
                                                      Given the similarity of their physical-               chemical substances for the described                 requirements, and applicability of the
                                                    chemical properties to those of NMP,                    significant new use.                                  rule to uses occurring before the
                                                    NEP, and NiPP can be used in ways                          3. EPA would be able to either                     effective date of the final rule.
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                                                    similar to NMP resulting in potential                   determine that the prospective                           Provisions relating to user fees appear
                                                    dermal and inhalation exposures.                        manufacture or processing is not likely               at 40 CFR part 700. According to 40 CFR
                                                    III. Rationale and Objectives                           to present an unreasonable risk, or to                721.1(c), persons subject to SNURs must
                                                                                                            take necessary regulatory action                      comply with the same notice
                                                    A. Rationale                                            associated with any other                             requirements and EPA regulatory
                                                      EPA is concerned about the potential                  determination, before the described                   procedures as submitters of
                                                    for adverse health effects of NEP and                   significant new use of the chemical                   Premanufacture Notices (PMNs) under
                                                    NiPP based on data on the adverse                       substance occurs.                                     TSCA section 5(a)(1)(A). In particular,


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                                                                         Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules                                          85475

                                                    these requirements include the                          57846) (FRL–9951–06), (see page                         SNUN submitters should be aware
                                                    information submission requirements of                  57848).                                               that EPA will be better able to evaluate
                                                    TSCA section 5(b) and 5(d)(1), the                         Persons who begin commercial                       SNUNs and define the terms of any
                                                    exemptions authorized by TSCA section                   manufacture or processing of the                      potentially necessary controls if the
                                                    5(h)(1), (h)(2), (h)(3), and (h)(5), and the            chemical substances for a significant                 submitter provides detailed information
                                                    regulations at 40 CFR part 720. Once                    new use identified as of November 17,                 on human exposure and environmental
                                                    EPA receives a SNUN, EPA must either                    2016 would have to cease any such                     releases that may result from the
                                                    determine that the significant new use                  activity upon the effective date of the               significant new uses of the chemical
                                                    is not likely to present an unreasonable                final rule. To resume their activities,               substance.
                                                    risk of injury or take such regulatory                  these persons would have to first
                                                    action as is associated with an                         comply with all applicable SNUR                       VIII. SNUN Submissions
                                                    alternative determination before the                    notification requirements and wait until                 EPA recommends that submitters
                                                    manufacture or processing for the                       all TSCA prerequisites for the                        consult with the Agency prior to
                                                    significant new use can commence. If                    commencement of manufacture or                        submitting a SNUN to discuss what
                                                    EPA determines that the significant new                 processing have been satisfied. Consult               information may be useful in evaluating
                                                    use is not likely to present an                         the Federal Register document of April                a significant new use. Discussions with
                                                    unreasonable risk, EPA is required                      24, 1990 (55 FR 17376) for a more                     the Agency prior to submission can
                                                    under TSCA section 5(g) to make public,                 detailed discussion of the cutoff date for            afford ample time to conduct any tests
                                                    and submit for publication in the                       ongoing uses.                                         that might be helpful in evaluating risks
                                                    Federal Register, a statement of EPA’s                  VII. Development and Submission of                    posed by the substance. According to 40
                                                    finding.                                                Information                                           CFR 721.1(c), persons submitting a
                                                       Persons who export or intend to                                                                            SNUN must comply with the same
                                                    export a chemical substance identified                     EPA recognizes that TSCA section 5                 notice requirements and EPA regulatory
                                                    in a proposed or final SNUR are subject                 does not usually require developing                   procedures as persons submitting a
                                                    to the export notification provisions of                new information (e.g., generating test                PMN, including submission of test data
                                                    TSCA section 12(b). The regulations that                data) before submission of a SNUN.                    on health and environmental effects as
                                                    interpret TSCA section 12(b) appear at                  There is an exception: Development of                 described in 40 CFR 720.50. SNUNs
                                                    40 CFR part 707, subpart D. Persons                     information is required where the                     must be submitted on EPA Form No.
                                                    who import a chemical substance                         chemical substance subject to the SNUR                7710–25, generated using e-PMN
                                                    identified in a final SNUR are subject to               is also subject to a rule, order, or                  software, and submitted to the Agency
                                                    the TSCA section 13 import certification                consent agreement under TSCA section                  in accordance with the procedures set
                                                    requirements, codified at 19 CFR 12.118                 4 (see TSCA section 5(b)(1)).                         forth in 40 CFR 721.25 and 40 CFR
                                                    through 12.127; see also 19 CFR 127.28.                    In the absence of a section 4 test rule
                                                                                                                                                                  720.40. E–PMN software is available
                                                    Those persons must certify that the                     covering the chemical substance,
                                                                                                                                                                  electronically at http://www.epa.gov/
                                                    shipment of the chemical substance                      persons are required to submit only
                                                                                                            information in their possession or                    opptintr/newchems.
                                                    complies with all applicable rules and
                                                    orders under TSCA, including any                        control and to describe any other                     IX. Economic Analysis
                                                    SNUR requirements. The EPA policy in                    information known to or reasonably
                                                                                                            ascertainable by them (15 U.S.C.                      A. SNUNs
                                                    support of import certification appears
                                                    at 40 CFR part 707, subpart B.                          2604(d); 40 CFR 721.25, and 40 CFR                      EPA has evaluated the potential costs
                                                                                                            720.50). However, as a general matter,                of establishing SNUR reporting
                                                    VI. Applicability of Rule to Uses                       EPA recommends that SNUN submitters                   requirements for potential
                                                    Occurring Before Effective Date of the                  include information that would permit                 manufacturers and processors of the
                                                    Final Rule                                              a reasoned evaluation of risks posed by               chemical substance included in this
                                                       EPA designates November 17, 2016                     the chemical substance during its                     proposed rule (Ref. 3). In the event that
                                                    (the date of public release/web posting                 manufacture, processing, use,                         a SNUN is submitted, costs are
                                                    of this proposal) as the cutoff date for                distribution in commerce, or disposal.                estimated at approximately $8,900 per
                                                    determining whether the new use is                      EPA encourages persons to consult with                SNUN submission for large business
                                                    ongoing. This designation varies slightly               the Agency before submitting a SNUN.                  submitters and $6,500 for small
                                                    from EPA’s past practice of designating                 As part of this optional pre-notice                   business submitters. These estimates
                                                    the date of Federal Register publication                consultation, EPA would discuss                       include the cost to prepare and submit
                                                    as the date for making this                             specific information it believes may be               the SNUN, and the payment of a user
                                                    determination (Ref. 13). The objective of               useful in evaluating a significant new                fee. Businesses that submit a SNUN
                                                    EPA’s approach has been to ensure that                  use.                                                  would be subject to either a $2,500 user
                                                    a person could not defeat a SNUR by                        Submitting a SNUN that does not                    fee required by 40 CFR 700.45(b)(2)(iii),
                                                    initiating a significant new use before                 itself include information sufficient to              or, if they are a small business with
                                                    the effective date of the final rule. In                permit a reasoned evaluation may                      annual sales of less than $40 million
                                                    developing this proposal, EPA has                       increase the likelihood that EPA will                 when combined with those of the parent
                                                    recognized that, given EPA’s practice of                either respond with a determination that              company (if any), a reduced user fee of
                                                    now posting proposed rules on its Web                   the information available to the Agency               $100 (40 CFR 700.45(b)(1)). EPA’s
                                                    site a week or more in advance of                       is insufficient to permit a reasoned                  complete economic analysis is available
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                                                    Federal Register publication, this                      evaluation of the health and                          in the public docket for this proposed
                                                    objective could be thwarted even before                 environmental effects of the significant              rule (Ref. 3).
                                                    that publication. Thus, EPA has slightly                new use or, alternatively, that in the
                                                    modified its approach in this                           absence of sufficient information, the                B. Export Notification
                                                    rulemaking and plans to follow this                     manufacture, processing, distribution in                Under section 12(b) of TSCA and the
                                                    modified approach in future significant                 commerce, use, or disposal of the                     implementing regulations at 40 CFR part
                                                    new use rulemakings. See the Federal                    chemical substance may present an                     707, subpart D, exporters must notify
                                                    Register of August 24, 2016, (81 FR                     unreasonable risk of injury.                          EPA if they export or intend to export


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                                                    85476                Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules

                                                    a chemical substance or mixture for                     factors, and including an unreasonable                XII. Request for Comment
                                                    which, among other things, a rule has                   risk to a potentially exposed or
                                                                                                                                                                  A. Do you have comments or
                                                    been proposed or promulgated under                      susceptible subpopulation identified as
                                                                                                                                                                  information about ongoing uses?
                                                    TSCA section 5. For persons exporting                   relevant by EPA), or (4) that there is
                                                    a substance that is the subject of a                    sufficient potential for environmental                   EPA welcomes comment on all
                                                    SNUR, a one-time notice to EPA must be                  release or human exposure (as defined                 aspects of this proposed rule. EPA based
                                                    provided for the first export or intended               in TSCA section 5(a)(3)(B)(ii)(II)), then             its understanding of the use profile of
                                                    export to a particular country. The total               manufacturing or processing for the                   these chemicals on the published
                                                    costs of export notification will vary by               significant new use cannot proceed                    literature, the 2012 Chemical Data
                                                    chemical, depending on the number of                    until EPA has responded to the                        Reporting submissions, market research,
                                                    required notifications (i.e., the number                circumstances by taking the required                  and review of Safety Data Sheets. To
                                                    of countries to which the chemical is                   actions under sections 5(e) or 5(f) of                confirm EPA’s understanding, the
                                                    exported). While EPA is unable to make                  TSCA.                                                 Agency is requesting public comment
                                                    any estimate of the likely number of                       In addition, EPA may not receive                   on all aspects of this proposed rule,
                                                    export notifications for the chemical                   important information from small                      including EPA’s understanding that
                                                    covered in this proposed SNUR, as                       businesses, because such firms generally              NiPP is not currently used, and NEP is
                                                    stated in the accompanying economic                     are exempt from TSCA section 8(a)                     not used except as a reactant, in silicone
                                                    analysis of this proposed SNUR, the                     reporting requirements (see TSCA                      seal remover, coatings, consumer and
                                                    estimated cost of the export notification               sections 8(a)(1)(A) and 8(a)(1)(B)). In               commercial paint primer, and
                                                    requirement on a per unit basis is $83.                 view of the level of health concerns                  adhesives. In providing comments on an
                                                                                                            about NEP and NiPP if used for a                      ongoing use of NEP and NiPP, it would
                                                    X. Alternatives                                         proposed significant new use, EPA                     be helpful if you provide sufficient
                                                      Before proposing this SNUR, EPA                       believes that a TSCA section 8(a) rule                information for EPA to substantiate any
                                                    considered the following alternative                    for this substance would not meet EPA’s               assertions of use. EPA does not have
                                                    regulatory action: Promulgate a TSCA                    regulatory objectives.                                specific information on the
                                                    Section 8(a) Reporting Rule.
                                                      Under a TSCA section 8(a) rule, EPA                   XI. Scientific Standards, Evidence, and               concentration by weight of NEP
                                                    could, among other things, generally                    Available Information                                 currently being used in silicone seal
                                                    require persons to report information to                   EPA has used scientific information,               remover, coatings, consumer and
                                                    the Agency when they intend to                          technical procedures, measures,                       commercial paint primer, and
                                                    manufacture or process a listed                         methods, protocols, methodologies, and                adhesives. If this information were
                                                    chemical for a specific use or any use.                 models consistent with the best                       available, EPA could better characterize
                                                    However, for NEP and NiPP, the use of                   available science, as applicable. These               the use. As such, EPA requests comment
                                                    TSCA section 8(a) rather than SNUR                      information sources supply information                on the concentration by weight of NEP
                                                    authority would have several                            relevant to whether a particular use                  currently being used in silicone seal
                                                    limitations. First, if EPA were to require              would be a significant new use, based                 remover, coatings, consumer and
                                                    reporting under TSCA section 8(a)                       on relevant factors including those                   commercial paint primer, and
                                                    instead of TSCA section 5(a), that action               listed under TSCA section 5(a)(2). As                 adhesives.
                                                    would not ensure that EPA receives                      noted in Unit III, EPA’s decision to                  B. What should I consider as I prepare
                                                    timely advance notice of any future                     propose a SNUR for a particular                       my comments for EPA?
                                                    manufacturing or processing of NEP and                  chemical use need not be based on an
                                                    NiPP for new uses that may produce                      extensive evaluation of the hazard,                     1. Submitting CBI. It is EPA’s policy
                                                    changes in human and environmental                      exposure, or potential risk associated                to include all comments received in the
                                                    exposures. Nor would it ensure that an                  with that use.                                        public docket without change or further
                                                    appropriate determination (relevant to                     The clarity and completeness of the                notice to the commenter and to make
                                                    the risks of such manufacturing or                      data, assumptions, methods, quality                   the comments available on-line at
                                                    processing) has been issued prior to the                assurance, and analyses employed in                   www.regulations.gov, including any
                                                    commencement of such manufacturing                      EPA’s decision are documented, as                     personal information provided, unless a
                                                    or processing. Furthermore, a TSCA                      applicable and to the extent necessary                comment includes information claimed
                                                    section 8(a) rule would not ensure that,                for purposes of this proposed significant             to be CBI or other information whose
                                                    in the event that EPA determines: (1)                   new use rule, in Unit II and in the                   disclosure is restricted by statute. Do
                                                    That the significant new use presents an                references noted above. EPA recognizes,               not submit this information to EPA
                                                    unreasonable risk under the conditions                  based on the available information, that              through regulations.gov or email.
                                                    of use (without consideration of costs or               there is variability and uncertainty in               Clearly mark the part or all of the
                                                    other nonrisk factors, and including an                 whether any particular significant new                information that you claim to be CBI.
                                                    unreasonable risk to a potentially                      use would actually present an                         For CBI information in a disk or CD
                                                    exposed or susceptible subpopulation                    unreasonable risk. For precisely this                 ROM that you mail to EPA, mark the
                                                    identified as relevant by EPA); (2) that                reason, it is appropriate to secure a                 outside of the disk or CD ROM that you
                                                    the information available to EPA is                     future notice and review process for                  mail to EPA as CBI and then identify
                                                    insufficient to permit a reasoned                       these uses, at such time as they are                  electronically within the disk or CD
                                                    evaluation of the health and                            known more definitely. The extent to                  ROM the specific information that is
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                                                    environmental effects of the significant                which the various information,                        claimed as CBI. In addition to one
                                                    new use; (3) that in the absence of                     procedures, measures, methods,                        complete version of the comment that
                                                    sufficient information, the manufacture,                protocols, methodologies or models                    includes information claimed as CBI, a
                                                    processing, distribution in commerce,                   used in EPA’s decision have been                      copy of the comment that does not
                                                    use, or disposal of the substance, or any               subject to independent verification or                contain the information claimed as CBI
                                                    combination of such activities, may                     peer review is adequate to justify their              must be submitted for inclusion in the
                                                    present an unreasonable risk (without                   use, collectively, in the record for a                public docket. Information so marked
                                                    consideration of costs or other nonrisk                 significant new use rule                              will not be disclosed except in


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                                                                         Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules                                           85477

                                                    accordance with procedures set forth in                 Development and Behavior in Rats.                     collection instrument, or form, as
                                                    40 CFR part 2, subpart B.                               Neurotoxicology and Teratology, 16(3), 241–           applicable.
                                                      2. Tips for preparing your comments.                  249.
                                                                                                              11. Bader, M., R. Wrbitzky, M.                      C. Regulatory Flexibility Act (RFA)
                                                    When preparing and submitting your
                                                                                                            Blaszkewicz, M. Schaper, and C. van Thriel.              Pursuant to section 605(b) of the RFA,
                                                    comments, see the commenting tips at                    2008. Human Volunteer Study on the
                                                    http://www2.epa.gov/dockets/                                                                                  5 U.S.C. 601 et seq., I certify that
                                                                                                            Inhalational and Dermal Absorption of N-
                                                    commenting-epa-dockets#tips.                            Methyl-2-Pyrrolidone (NMP) from the                   promulgation of this SNUR would not
                                                                                                            Vapour Phase. Archives of Toxicology, 82(1),          have a significant economic impact on
                                                    XIII. References                                        13–20.                                                a substantial number of small entities.
                                                      The following is a listing of the                       12. Keener, S., R. Wrbitzky, and M. Bader.          The rationale supporting this
                                                    documents that are specifically                         2007. Human Volunteer Study on the                    conclusion is as follows.
                                                    referenced in this document. The docket                 Influence of Exposure Dilution of Dermally               A SNUR applies to any person
                                                                                                            Applied N-Methyl-2-Pyrrolidone (NMP) on               (including small or large entities) who
                                                    includes these documents and other
                                                                                                            the Urinary Elimination of NMP Metabolites.           intends to engage in any activity
                                                    information considered by EPA,                          International Archives of Occupational and
                                                    including documents that are referenced                                                                       described in the rule as a ‘‘significant
                                                                                                            Environmental Health, 80(4), 327–334.
                                                    within the documents that are included                    13. EPA. Significant New Uses of Certain
                                                                                                                                                                  new use.’’ By definition of the word
                                                    in the docket, even if the referenced                   Chemical Substances; Final Rule. RIVM,                ‘‘new’’ and based on all information
                                                    document is not physically located in                   2013). Federal Register (April 24, 1990, 55           currently available to EPA, it appears
                                                    the docket. For assistance in locating                  FR 17376) (FRL–3658–5).                               that no small or large entities presently
                                                    these other documents, please consult                                                                         engage in such activities. Since this
                                                    the technical person listed under FOR                   XIV. Statutory and Executive Order                    SNUR will require a person who intends
                                                    FURTHER INFORMATION CONTACT.                            Reviews                                               to engage in such activity in the future
                                                                                                                                                                  to first notify EPA by submitting a
                                                      1. ECHA, Committee for Risk Assessment.               A. Executive Order 12866: Regulatory                  SNUN, no economic impact will occur
                                                    Annex 1 Background document to the                      Planning and Review and Executive                     unless someone files a SNUN to pursue
                                                    Opinion proposing harmonised classification             Order 13563: Improving Regulation and
                                                    and labelling at Community level of N-ethyl-                                                                  a significant new use in the future or
                                                                                                            Regulatory Review                                     forgoes profits by avoiding or delaying
                                                    2-pyrrolidone (NEP). ECHA/RAC/CLH–O–
                                                    0000002192–83–01/A1. 2011.                                 This proposed SNUR is not a                        the significant new use. Although some
                                                      2. Vandeputte, Bart; Moonen, Kristof; and             ‘‘significant regulatory action’’ and was             small entities may decide to conduct
                                                    Roose, Peter. Use of improved N-alkyl                   therefore not submitted to the Office of              such activities in the future, EPA cannot
                                                    pyrrolidone solvents. Google Patents.                   Management and Budget (OMB) for                       presently determine how many, if any,
                                                    Publication Number: US20150057375 A1.                   review under Executive Orders 12866                   there may be. However, EPA’s
                                                    Filing Date: January 17, 2013. Publication              (58 FR 51735, October 4, 1993) and                    experience to date is that, in response to
                                                    Date: February 26, 2015. Available at http://           13563 (76 FR 3821, January 21, 2011).                 the promulgation of SNURs covering
                                                    www.google.com/patents/
                                                                                                                                                                  over 1,000 chemical substances, the
                                                    WO2013107822A1?cl=en.                                   B. Paperwork Reduction Act (PRA)
                                                      3. EPA. Economic Analysis of the Proposed                                                                   Agency receives only a handful of
                                                    Significant New Use Rule for
                                                                                                              This action does not impose any new                 notices per year. During the six year
                                                    Alkylpyrrolidones. March 31, 2016.                      information collection burden under the               period from 2005–2010, only three
                                                      4. BASF. N-Ethylpyrrolidone-2 (NEP)                   PRA, 44 U.S.C. 3501 et seq. Burden is                 submitters self-identified as small in
                                                    Technical Data Sheet. July 2009. Available at           defined in 5 CFR 1320.3(b). The                       their SNUN submission (Ref. 3). EPA
                                                    http://worldaccount.basf.com/wa/                        information collection activities                     believes the cost of submitting a SNUN
                                                    NAFTA∼es_MX/Catalog/ChemicalsNAFTA/                     associated with existing chemical                     is relatively small compared to the cost
                                                    doc4/BASF/PRD/30036616/                                 SNURs are already approved under                      of developing and marketing a chemical
                                                    .pdf?urn=urn:documentum:eCommerce_sol_                  OMB control number 2070–0038 (EPA
                                                    EU:09007bb280065a74.pdf.
                                                                                                                                                                  new to a firm or marketing a new use
                                                                                                            ICR No. 1188); and the information                    of the chemical and that the
                                                      5. EPA. Chemical and Product Categories
                                                    (CPCat) Database. Accessed September 2015.
                                                                                                            collection activities associated with                 requirement to submit a SNUN
                                                    Available at http://actor.epa.gov/cpcat/faces/          export notifications are already                      generally does not have a significant
                                                    home.xhtml.                                             approved under OMB control number                     economic impact.
                                                      6. BASF Corp Germany. N-                              2070–0030 (EPA ICR No. 0795). If an                      Therefore, EPA believes that the
                                                    Ethylpyrrolidone. Accessed August 2016.                 entity were to submit a SNUN to the                   potential economic impact of complying
                                                    Available at https://www.standort-                      Agency, the annual burden is estimated                with this proposed SNUR is not
                                                    ludwigshafen.basf.de/group/corporate/site-              to be less than 100 hours per response,               expected to be significant or adversely
                                                    ludwigshafen/en/brand/N_                                and the estimated burden for export                   impact a substantial number of small
                                                    ETHYLPYRROLIDONE.                                       notifications is less than 1.5 hours per
                                                      7. EPA. Downloadable of the Non-
                                                                                                                                                                  entities. In a SNUR that published as a
                                                    Confidential Chemical Reporting Data (CDR)
                                                                                                            notification. In both cases, burden is                final rule on August 8, 1997 (62 FR
                                                    Database. Downloaded July 2014.                         estimated to be reduced for submitters                42690) (FRL–5735–4), the Agency
                                                      8. Sitarek, K., J. Stekiewicz, and W.                 who have already registered to use the                presented its general determination that
                                                    Wasowicz. 2012. Evaluation of Reproductive              electronic submission system.                         proposed and final SNURs are not
                                                    Disorders in Female Rats Exposed to N-                    An agency may not conduct or                        expected to have a significant economic
                                                    Methyl-2-Pyrrolidone. Birth Defects Research            sponsor, and a person is not required to              impact on a substantial number of small
                                                    (Part B), 95, 195–201.                                  respond to a collection of information                entities.
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                                                      9. Saillenfait, A. M., F. Gallissot, I.               that requires OMB approval under the
                                                    Langonne, and J. P. Sabate. 2002.                       PRA, unless it has been approved by                   D. Unfunded Mandates Reform Act
                                                    Developmental Toxicity of NMethyl-2-                    OMB and displays a currently valid                    (UMRA)
                                                    Pyrrolidone Administered Orally to Rats.
                                                    Food Chemistry and Toxicology, 40(11),
                                                                                                            OMB control number. The OMB control                     Based on EPA’s experience with
                                                    1705–1712.                                              numbers for EPA’s regulations in Title                proposing and finalizing SNURs, State,
                                                      10. Hass, U., S. P. Lund, and J. Elsner.              40 of the CFR, after appearing in the                 local, and Tribal governments have not
                                                    1994. Effects of Prenatal Exposure to N-                Federal Register, are listed in 40 CFR,               been impacted by these rulemakings,
                                                    Methylpyrrolidone on Postnatal                          part 9, and included on the related                   and EPA does not have any reason to


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                                                    85478                Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Proposed Rules

                                                    believe that any State, local, or Tribal                J. Executive Order 12898: Federal                      DEPARTMENT OF TRANSPORTATION
                                                    government would be impacted by this                    Actions To Address Environmental
                                                    rulemaking. As such, the requirements                   Justice in Minority Populations and                    National Highway Traffic Safety
                                                    of sections 202, 203, 204, or 205 of                    Low-Income Populations                                 Administration
                                                    UMRA, 2 U.S.C. 1531–1538, do not
                                                    apply to this action.                                     This action will not have                            49 CFR Part 575
                                                                                                            disproportionately high and adverse
                                                    E. Executive Order 13132: Federalism                                                                           [NHTSA–2015–0096]
                                                                                                            human health or environmental effects
                                                                                                            on minority or low-income populations                  RIN 2127–AL33
                                                      This action will not have federalism
                                                    implications as specified in Executive                  as specified in Executive Order 12898
                                                                                                                                                                   Vehicle Defect Reporting
                                                    Order 13132 (64 FR 43255, August 10,                    (59 FR 7629, February 16, 1994). This
                                                                                                                                                                   Requirements
                                                    1999), because it will not have                         action does not affect the level of
                                                    substantial direct effect on States, on the             protection provided to human health or                 AGENCY: National Highway Traffic
                                                    relationship between the national                       the environment.                                       Safety Administration (NHTSA),
                                                    government and the States, or on the                                                                           Department of Transportation (DOT).
                                                                                                            List of Subjects in 40 CFR Part 721
                                                    distribution of power and                                                                                      ACTION: Notice of proposed rulemaking
                                                    responsibilities among the various                        Environmental protection, Chemicals,                 (NPRM).
                                                    levels of government.                                   Hazardous substances, Reporting and
                                                                                                                                                                   SUMMARY:   NHTSA is proposing to
                                                    F. Executive Order 13175: Consultation                  recordkeeping requirements.
                                                                                                                                                                   require placing a label on the passenger
                                                    and Coordination With Indian Tribal                       Dated: November 14, 2016.                            side sun visor of light-duty vehicles that
                                                    Governments                                             Jeffery T. Morris,                                     provides information about how to
                                                                                                            Acting Director, Office of Pollution Prevention        submit a safety-related motor vehicle
                                                       This action does not have tribal
                                                                                                            and Toxics.                                            defect complaint to NHTSA. This
                                                    implications as specified in Executive
                                                                                                                                                                   rulemaking also proposes updating the
                                                    Order 13175 (65 FR 67249, November 9,
                                                                                                              Therefore, it is proposed that 40 CFR                required information in 49 CFR 575.6
                                                    2000), because it will not have any
                                                                                                            chapter I be amended as follows:                       for defect reporting information in
                                                    effect on tribal governments, on the
                                                                                                                                                                   owner’s manuals through the addition
                                                    relationship between the Federal
                                                                                                            PART 721—[AMENDED]                                     of the text developed for this proposal.
                                                    Government and the Indian tribes, or on
                                                                                                                                                                   This proposal responds to the mandate
                                                    the distribution of power and
                                                                                                            ■ 1. The authority citation for part 721               in the Moving Ahead for Progress in the
                                                    responsibilities between the Federal
                                                                                                            continues to read as follows:                          21st Century Act of 2012 (MAP–21) that
                                                    Government and Indian tribes.
                                                                                                                                                                   manufacturers be required to affix, in
                                                                                                              Authority: 15 U.S.C. 2604, 2607, and
                                                    G. Executive Order 13045: Protection of                                                                        the glove compartment or in another
                                                                                                            2625(c).
                                                    Children From Environmental Health                                                                             readily accessible location on the
                                                    Risks and Safety Risks                                  ■ 2. Add § 721.10925 to subpart E to                   vehicle, a sticker, decal, or other device
                                                                                                            read as follows:                                       that provides, in simple and
                                                       This action is not subject to Executive                                                                     understandable language, information
                                                    Order 13045 (62 FR 19885, April 23,                     § 721.10925       Alkylpyrrolidones.                   about how to submit a safety-related
                                                    1997), because this action does not                                                                            motor vehicle defect complaint to
                                                    address environmental health or safety                    (a) Chemical substance and
                                                                                                                                                                   NHTSA; and prominently print the
                                                    risks, and EPA interprets Executive                     significant new uses subject to reporting.
                                                                                                                                                                   information described above within the
                                                    Order 13045 as applying only to those                   (1) The chemical substances N-
                                                                                                                                                                   owner’s manual.
                                                    regulatory actions that concern                         ethylpyrrolidone (CASRN 2687–91–4)
                                                                                                                                                                   DATES: Comments must be received on
                                                    environmental health or safety risks that               and N-isopropylpyrrolidone (CASRN
                                                                                                                                                                   or before January 27, 2017. See the
                                                    EPA has reason to believe may                           3772–26–7) are subject to reporting
                                                                                                                                                                   SUPPLEMENTARY INFORMATION section on
                                                    disproportionately affect children, per                 under this section for the significant
                                                                                                                                                                   ‘‘Public Participation’’ for more
                                                    the definition of ‘‘covered regulatory                  new uses described in paragraph (a)(2)
                                                                                                                                                                   information about written comments.
                                                    action’’ in section 2–202 of the                        of this section.
                                                    Executive Order.                                                                                               ADDRESSES: You may submit your
                                                                                                              (2) The significant new uses are:                    comments, identified by Docket ID No.
                                                    H. Executive Order 13211: Actions                         (i) For N-ethylpyrrolidone (CASRN                    NHTSA–2015–0096, by any of the
                                                    Concerning Regulations That                             2687–91–4), any use except for use as                  following methods:
                                                    Significantly Affect Energy Supply,                     reactant and in silicone seal remover,                    • http://www.regulations.gov: Follow
                                                    Distribution, or Use                                    coatings, consumer and commercial                      the online instructions for submitting
                                                                                                            paint primer, and adhesives.                           comments.
                                                      This action is not a ‘‘significant                                                                              • Fax: NHTSA: (202) 493–2251.
                                                    energy action’’ as defined in Executive                   (ii) For N-isopropylpyrrolidone                         • Mail:
                                                    Order 13211 (66 FR 28355, May 22,                       (CASRN 3772–26–7), any use.                               Æ Docket Management Facility, M–30,
                                                    2001), because it is not likely to have                   (b) [Reserved]                                       U.S. Department of Transportation, 1200
                                                    any effect on energy supply,                                                                                   New Jersey Avenue SE., West Building,
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                                                                                                            [FR Doc. 2016–28565 Filed 11–25–16; 8:45 am]
                                                    distribution, or use.                                                                                          Ground Floor, Rm. W12–140,
                                                                                                            BILLING CODE 6560–50–P
                                                    I. National Technology Transfer and                                                                            Washington, DC 20590, Attention
                                                    Advancement Act (NTTAA)                                                                                        Docket ID No. NHTSA–2015–0096.
                                                                                                                                                                      • Hand Delivery:
                                                      This rulemaking does not involve any                                                                            Æ Department of Transportation, 1200
                                                    technical standards, and is therefore not                                                                      New Jersey Avenue SE., West Building,
                                                    subject to considerations under section                                                                        Ground Floor, Rm. W12–140,
                                                    12(d) of NTTAA, 15 U.S.C.272 note.                                                                             Washington, DC 20590, Attention


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Document Created: 2018-02-14 08:36:15
Document Modified: 2018-02-14 08:36:15
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 January 27, 2017.
ContactFor technical information contact: Tyler Lloyd, 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 85472 
RIN Number2070-AK09
CFR AssociatedEnvironmental Protection; Chemicals; Hazardous Substances and Reporting and Recordkeeping Requirements

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