81 FR 85472 - Alkylpyrrolidones; Significant New Use Rule

ENVIRONMENTAL PROTECTION AGENCY

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

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, 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]]

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

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.

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

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