[Federal Register Volume 85, Number 55 (Friday, March 20, 2020)]
[Rules and Regulations]
[Pages 15952-15959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05351]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2018-0772; FRL-10005-30]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances (19-1.B)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for the chemical substances 
identified in Unit IV. which were the subject of premanufacture notices 
(PMNs). This action requires persons to notify EPA least 90 days before 
commencing manufacture (defined by statute to include import) or 
processing of any of these chemical substances for an activity that is 
designated as a significant new use by this rule. The required 
notification initiates EPA's evaluation of the intended use within the 
applicable review period. Persons may not commence manufacture or 
processing for the significant new use until EPA has conducted a review 
of the notice, made an appropriate determination on the notice, and has

[[Page 15953]]

taken such actions as are required as a result of that determination.

DATES: This rule is effective on May 19, 2020. For purposes of judicial 
review, this rule shall be promulgated at 1 p.m. (EST) on April 3, 
2020.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 564-9232; email address: moss.kenneth@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28. Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and Orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after April 20, 2020 
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.

B. How can I access the docket?

    The docket includes information considered by the Agency in 
developing the proposed and final rules. The docket for this action, 
identified by docket identification (ID) number EPA-HQ-OPPT-2018-0772, 
is available at http://www.regulations.gov or at the Office of 
Pollution Prevention and Toxics Docket (OPPT Docket), Environmental 
Protection Agency Docket Center (EPA/DC), West William Jefferson 
Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPPT 
Docket is (202) 566-0280. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

A. What action is the agency taking?

    EPA is finalizing a SNUR under TSCA section 5(a)(2) for chemical 
substances which were the subject of PMNs P-14-482, P-16-422, P-17-152, 
P-17-239, P-17-245, P-18-48, P-18-73, P-18-122, P-18-162, P-18-222, and 
P-19-10. These SNURs require persons who intend to manufacture or 
process any of these chemical substances for an activity that is 
designated as a significant new use to notify EPA at least 90 days 
before commencing that activity.
    Previously, in the Federal Register of April 19, 2019 (84 FR 16432) 
(FRL-9992-42), EPA proposed a SNUR for these chemical substances in 40 
CFR part 721, subpart E. More information on the specific chemical 
substances subject to this final rule can be found in the Federal 
Register documents proposing the SNUR. The record for the SNUR was 
established in the docket under docket ID number EPA-HQ-OPPT-2018-0772. 
That docket includes information considered by the Agency in developing 
the proposed and final rules, public comments submitted for the rule, 
and EPA's responses to public comments received on the proposed rule.

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

    TSCA section 5(a)(2), 15 U.S.C. 2604(a)(2), authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. As described in Unit V., the general SNUR 
provisions are found at 40 CFR part 721, subpart A.

C. Applicability of general provisions

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

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors. In 
determining what would constitute a significant new use for the 
chemical substances that are

[[Page 15954]]

the subject of these SNURs, EPA considered relevant information about 
the toxicity of the chemical substances, and potential human exposures 
and environmental releases that may be associated with the conditions 
of use of the substances, in the context of the four bulleted TSCA 
section 5(a)(2) factors listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

    EPA received public comments from two identifying entities on the 
proposed rule. The Agency's responses are described in a separate 
Response to Public Comments document contained in the public docket for 
this rule, EPA-HQ-OPPT-2018-0772.
    In addition, the Agency is correcting the proposed regulatory text 
that appeared in the proposed SNUR at 40 CFR 721.11253. Paragraph 
(a)(1) of the proposed regulatory text erroneously describes the 
chemical substance as organic salt, rather than sulfuric acid, ammonium 
salt (1:?), which is listed correctly in both the title of the proposed 
SNUR and in Unit IV. of the proposed SNUR. This oversight has been 
corrected in the final regulatory text for the SNUR.

V. Substances Subject to This Rule

    EPA is establishing significant new use and recordkeeping 
requirements for chemical substances in 40 CFR part 721, subpart E. In 
Unit IV of the April 19, 2019 proposed rule, EPA provided the following 
information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the SNUR.
     Potentially Useful Information. Information identified by 
EPA that would help characterize the potential health and/or 
environmental effects of the chemical substances if a manufacturer or 
processor is considering submitting a SNUN for a significant new use 
designated by the SNUR.
     CFR citation assigned in the regulatory text section of 
these rules.
    The regulatory text section of these rules specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits and other uses designated in the rules, may be 
claimed as CBI.
    The chemical substances that are the subject of these SNURs 
completed premanufacture review. In addition to those conditions of use 
intended by the submitter, EPA has identified certain other reasonably 
foreseen conditions of use. EPA has preliminarily determined that the 
chemicals under their intended conditions of use are not likely to 
present an unreasonable risk. However, EPA has not assessed risks 
associated with the reasonably foreseen conditions of use for these 
chemicals. EPA is designating these reasonably foreseen and other 
potential conditions of use as significant new uses. As a result, those 
conditions of use are no longer reasonably foreseen to occur without 
first going through a separate, subsequent EPA review and determination 
process associated with a SNUN.

VI. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subject of these SNURs and as further discussed in Unit 
IV. of the April 19, 2019 proposed rule, EPA identified certain 
reasonably foreseen conditions of use and other circumstances different 
from the intended conditions of use identified in the PMNs and 
determined that those changes could result in changes in the type or 
form of exposure to the chemical substances and/or increased exposures 
to the chemical substances and/or changes in the reasonably anticipated 
manner and methods of manufacturing, processing, distribution in 
commerce, and disposal of the chemical substances.

B. Objectives

    EPA is issuing these SNURs because the Agency wants:
     To receive notice of any person's intent to manufacture or 
process a listed chemical substance for the described significant new 
use before that activity begins.
     To have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     To be obligated to make a determination under TSCA section 
5(a)(3) regarding the use described in the SNUN, under the conditions 
of use. The Agency will either determine under section 5(a)(3)(C) that 
the significant new use is not likely to present an unreasonable risk, 
including an unreasonable risk to a potentially exposed or susceptible 
subpopulation identified as relevant by the Administrator under the 
conditions of use, or make a determination under section 5(a)(3) (A) or 
(B) and take the required regulatory action associated with the 
determination, before manufacture or processing for the significant new 
use of the chemical substance can occur.
     To be able to identify as significant new uses any 
manufacturing, processing, use, distribution in commerce, or disposal 
that does not conform to the restrictions imposed by the underlying 
Orders, consistent with TSCA section 5(f)(4).
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VII. Applicability of the Significant New Use Designation

    To establish a significant new use, EPA must determine that the use 
is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. In cases where EPA has not received a 
notice of commencement (NOC) and the chemical substance has not been 
added to the TSCA Inventory, no person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    EPA designated April 15, 2019 (the date of web posting of the 
proposed rule) as the cutoff date for determining whether the new use 
is ongoing. 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 the unlikely event that a person began commercial manufacture or 
processing of the chemical substances for a significant new use 
identified as of April 15, 2019, that person will have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, that person would have to first comply with all 
applicable SNUR notification requirements and wait until EPA has 
conducted a review of the notice, made an appropriate determination on 
the notice, and has taken such actions as are required with that 
determination.

VIII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require development of 
any particular new information (e.g.,

[[Page 15955]]

generating test data) before submission of a SNUN. There is an 
exception: If a person is required to submit information for a chemical 
substance pursuant to a rule, Order or consent agreement under TSCA 
section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 
2604(b)(1)(A)) requires such information to be submitted to EPA at the 
time of submission of the SNUN.
    In the absence of a rule, Order, or consent agreement under TSCA 
section 4 covering the chemical substance, persons are required only to 
submit information in their possession or control and to describe any 
other information known to or reasonably ascertainable by them (see 40 
CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. Unit IV. of the April 19, 
2019 proposed rule lists potentially useful information for all SNURs 
listed here. Descriptions are provided for informational purposes. The 
potentially useful information identified in Unit IV. of the proposed 
rule will be useful to EPA's evaluation in the event that someone 
submits a SNUN for the significant new use. Companies who are 
considering submitting a SNUN are encouraged, but not required, to 
develop the information on the substance. EPA strongly encourages 
persons, before performing any testing, to consult with the Agency. 
Furthermore, pursuant to TSCA section 4(h), which pertains to reduction 
of testing in vertebrate animals, EPA encourages consultation with the 
Agency on the use of alternative test methods and strategies (also 
called New Approach Methodologies, or NAMs), if available, to generate 
the recommended test data. EPA encourages dialog with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h).
    The potentially useful information described in Unit IV. of the 
proposed rule may not be the only means of providing information to 
evaluate the chemical substance associated with the significant new 
uses. However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e) or 5(f). 
EPA recommends that potential SNUN submitters contact EPA early enough 
so that they will be able to conduct the appropriate tests.
    SNUN submitters should provide detailed information on the 
following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture or process the chemical 
substance, EPA will tell the person whether the use identified in the 
bona fide submission would be a significant new use under the rule. 
Since most of the chemical identities of the chemical substances 
subject to these SNURs are also CBI, manufacturers and processors can 
combine the bona fide submission under the procedure in 40 CFR 
721.1725(b)(1) with that under 40 CFR 721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture or process the chemical substance so long as the 
significant new use trigger is not met. In the case of a production 
volume trigger, this means that the aggregate annual production volume 
does not exceed that identified in the bona fide submission to EPA. 
Because of confidentiality concerns, EPA does not typically disclose 
the actual production volume that constitutes the use trigger. Thus, if 
the person later intends to exceed that volume, a new bona fide 
submission would be necessary to determine whether that higher volume 
would be a significant new use.

X. SNUN Submissions

    According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 40 CFR 720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in 40 CFR 720.40. E-PMN software is available electronically 
at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2018-0772.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This action establishes SNURs for several new chemical substances 
that were the subject of PMNs and TSCA section 5(e) Orders. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866 (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this action. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.

[[Page 15956]]

    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including using 
automated collection techniques, to the Director, Regulatory Support 
Division, Office of Mission Support (2822T), Environmental Protection 
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA (5 U.S.C. 601 et seq.), the 
Agency hereby certifies that promulgation of this SNUR would not have a 
significant adverse economic impact on a substantial number of small 
entities. The requirement to submit a SNUN applies to any person 
(including small or large entities) who intends to engage in any 
activity described in the final rule as a ``significant new use.'' 
Because these uses are ``new,'' based on all information currently 
available to EPA, it appears that no small or large entities presently 
engage in such activities. A SNUR requires that any person who intends 
to engage in such activity in the future must first notify EPA by 
submitting a SNUN. Although some small entities may decide to pursue a 
significant new use 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 chemicals, 
the Agency receives only a small number of notices per year. For 
example, the number of SNUNs received was seven in Federal fiscal year 
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 
11 in FY2018 and only a fraction of these were from small businesses. 
In addition, the Agency currently offers relief to qualifying small 
businesses by reducing the SNUN submission fee from $16,000 to $2,800. 
This lower fee reduces the total reporting and recordkeeping of cost of 
submitting a SNUN to about $10,116 for qualifying small firms. 
Therefore, the potential economic impacts of complying with this SNUR 
are not expected to be significant or adversely impact a substantial 
number of small entities. In a SNUR that published in the Federal 
Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this action. As 
such, EPA has determined that this action does not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action will not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

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

    This action does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
action does not significantly nor uniquely affect the communities of 
Indian Tribal governments, nor does it involve or impose any 
requirements that affect Indian Tribes. Accordingly, the requirements 
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply 
to this action.

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

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this is not an economically significant 
regulatory action as defined by Executive Order 12866, and this action 
does not address environmental health or safety risks 
disproportionately affecting children.

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

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because this action is not expected to affect energy 
supply, distribution, or use and because this action is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to 
this action.

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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994).

XIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: March 5, 2020.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671;

[[Page 15957]]

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 
1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and 
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 
42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 
300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 
et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.


0
2. In Sec.  9.1, add entries for Sec. Sec.  721.11247 through 721.11257 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
Sec.   721.11247........................................       2070-0012
Sec.   721.11248........................................       2070-0012
Sec.   721.11249........................................       2070-0012
Sec.   721.11250........................................       2070-0012
Sec.   721.11251........................................       2070-0012
Sec.   721.11252........................................       2070-0012
Sec.   721.11253........................................       2070-0012
Sec.   721.11254........................................       2070-0012
Sec.   721.11255........................................       2070-0012
Sec.   721.11256........................................       2070-0012
Sec.   721.11257........................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).


0
4. Add Sec. Sec.  721.11247 through 721.11257 to subpart E to read as 
follows:

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *
Sec.
721.11247 Organic salt (generic).
721.11248 1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) ester, 
ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-methylpropanoate).
721.11249 Alkylaminium-trialkyl-2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]-, halide (1:1), polymer with alpha-(2-methyl-1-oxo-2-propen-
1-yl)- omega-alkoxypoly(oxy-1,2-alkanediyl) (generic).
721.11250 Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] 
and 1,2-propanediol (generic) .
721.11251 Unsaturated polyfluoro ester, (generic).
721.11252 Acetic acid, 2-(2-butoxyethoxy)-.
721.11253 Sulfuric acid, ammonium salt (1:?).
721.11254 Alkylamide, polymer with alkylamine, formaldehyde, and 
polycyanamide, alkyl acid salt (generic).
721.11255 Cashew nutshell liquid, polymer with diisocyanatoalkane, 
substituted-polyoxyalkyldiol and polyether polyol (generic).
721.11256 Silane, ethenyltrimethoxy-, polymer with ethene and 1-
propene.
721.11257 Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, 
polypropylene glycol ether with trimethylolpropane (3:1), and 1,3-
propanediol, polypropylene glycol monomethacrylate-blocked 
(generic).
* * * * *


Sec.  721.11247   Organic salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organic 
salt (P-14-482) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to 
manufacture, process or use the substance in any manner that results in 
inhalation exposures. It is a significant new use to exceed the 
confidential annual production volume stated in the PMN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) though (c) and (i), are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section


Sec.  721.11248   1,2-Cyclohexanedicarboxylic acid, 1-(phenylmethyl) 
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,2-
Cyclohexanedicarboxyliccyclohexanedicarboxylic acid, 1-(phenylmethyl) 
ester, ester with 2,2,4-trimethyl-1,3-pentanediol mono(2-
methylpropanoate) (P-16-422, CAS No. 1661012-65-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance involving an application 
method that results in inhalation exposures. It is a significant new 
use to release a manufacturing, processing, or use stream associated 
with any use of the substance, other than releases from the 
confidential polymer additive use described in the PMN, into the waters 
of the United States exceeding a surface water concentration of 12 part 
per billion (ppb) using the methods described in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.


Sec.  721.11249   Alkylaminium-trialkyl-2-[(2-methyl-1-oxo-2-propen-1-
yl)oxy]-, halide (1:1), polymer with alpha-(2-methyl-1-oxo-2-propen-1-
yl)- omega-alkoxypoly(oxy-1,2-alkanediyl) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylaminium-trialkyl-2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]-, halide 
(1:1), polymer with alpha-(2-methyl-1-oxo-2-propen-1-yl)- omega-
alkoxypoly(oxy-1,2-alkanediyl) (PMN P-17-152) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.

[[Page 15958]]

    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance in 
any manner that results in inhalation exposure. It is a significant new 
use to manufacture or process the substance as a powder or solid.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=1.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11250   Substituted carboxylic acid, polymer with 2,4-
diisocyanato-1-methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and 
1,2-propanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as 
substituted carboxylic acid, polymer with 2,4-diisocyanato-1-
methylbenzene, hexanedioic acid, alpha-hydro-omega-
hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1'-methylenebis[4-
isocyanatobenzene], 2,2'-oxybis[ethanol], 1,1'-oxybis[2-propanol] and 
1,2-propanediol) (PMN P-17-239) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o). It is a significant new use to use the 
substance involving spray application that results in inhalation 
exposures. It is a significant new use to manufacture (includes 
importing) the substance to contain more than 20% residual isocyanate 
by weight.
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N=33.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11251   Unsaturated polyfluoro ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
unsaturated polyfluoro ester (P-17-245) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) Disposal. It is a significant new use to dispose of the 
substance and any waste streams containing the substance or its 
constituent breakdown products other than by sending them via a 
hazardous waste transporter to a hazardous waste incinerator permitted 
under the Resource Conservation and Recovery Act (RCRA) or an 
authorized state hazardous waste program.
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) through (k) are applicable to 
manufacturers, including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.


Sec.  721.11252  Acetic acid, 2-(2-butoxyethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as acetic acid, 2-(2-
butoxyethoxy)- (PMN P-18-48, CAS No. 82941-26-2) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance other than as emulsifier for 
metal working fluid.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11253   Sulfuric acid, ammonium salt (1:?).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as sulfuric acid, 
ammonium salt (1:?) (PMN P-18-73, CAS No. 10043-02-4) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j). It is a significant new use to use the 
substance other than a Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) inert ingredient, an anti-scalant, a chlorine stabilizer, 
or the additional confidential uses described in the PMN.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) thru (c) and (i), are applicable to manufacturers, including 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(iii) 
of this section.


Sec.  721.11254   Alkylamide, polymer with alkylamine, formaldehyde, 
and polycyanamide, alkyl acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylamide, polymer with alkylamine, formaldehyde, and polycyanamide, 
alkyl acid salt (PMN P-18-122) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.

[[Page 15959]]

    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to release a manufacturing, processing, or use 
stream associated with any use of the substances, other than the 
confidential chemical intermediate use described in the premanufacture 
notices, into the waters of the United States exceeding a surface water 
concentration of 1 part per billion (ppb) using the methods described 
in Sec.  721.91.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), (i), and (k) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11255   Cashew nutshell liquid, polymer with 
diisocyanatoalkane, substituted-polyoxyalkyldiol and polyether polyol 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cashew 
nutshell liquid, polymer with diisocyanatoalkane, substituted-
polyoxyalkyldiol and polyether polyol (PMN P-18-162) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture (including import) in a form other 
that as a paste.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11256   Silane, ethenyltrimethoxy-, polymer with ethene and 
1-propene.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as silane, 
ethenyltrimethoxy-, polymer with ethene and 1-propene (P-18-222) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture, process, or use the substance for 
uses other than as a reactive polymer for use in adhesive applications.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.


Sec.  721.11257   Hydrogenated fatty acid dimers, polymers with 1,1'-
methylenebis[4-isocyanatobenzene], polypropylene glycol, polypropylene 
glycol ether with trimethylolpropane (3:1), and 1,3-propanediol, 
polypropylene glycol monomethacrylate-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
hydrogenated fatty acid dimers, polymers with 1,1'-methylenebis[4-
isocyanatobenzene], polypropylene glycol, polypropylene glycol ether 
with trimethylolpropane (3:1), and 1,3-propanediol, polypropylene 
glycol monomethacrylate-blocked (P-19-10) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. It is a 
significant new use to use the substance involving an application 
method that results in inhalation exposures.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (c), and (i) are applicable to manufacturers, 
including importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2020-05351 Filed 3-19-20; 8:45 am]
 BILLING CODE 6560-50-P


