Document ID: EPA-HQ-OPPT-2018-0650-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules: Certain Chemical Substances
Posted Date: 2018-11-15T05:00Z

[Federal Register Volume 83, Number 221 (Thursday, November 15, 2018)]
[Proposed Rules]
[Pages 57634-57657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24380]

[[Page 57633]]

Vol. 83

Thursday,

No. 221

November 15, 2018

Part IV

Environmental Protection Agency

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

40 CFR Part 721

Significant New Use Rules on Certain Chemical Substances; Proposed Rule

  Federal Register / Vol. 83 , No. 221 / Thursday, November 15, 2018 / 
Proposed Rules  

[[Page 57634]]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2018-0650; FRL-9985-22]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing significant new use rules (SNURs) under the 
Toxic Substances Control Act (TSCA) for 66 chemical substances which 
were the subject of premanufacture notices (PMNs). The chemical 
substances are subject to Orders issued by EPA pursuant to section 5(e) 
of TSCA. This action would require persons who intend to manufacture 
(defined by statute to include import) or process any of these 66 
chemical substances for an activity that is proposed as a significant 
new use to notify EPA at least 90 days before commencing that activity. 
The required notification initiates EPA's evaluation of the intended 
use within the applicable review period. 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 taken such actions as are required with that 
determination.

DATES: Comments must be received on or before December 31, 2018.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2018-0650, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this proposed 
rule. The following list of North American Industrial Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers 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 final 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 proposed rule on or after 
December 17, 2018 are subject to the export notification provisions of 
TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), and must 
comply with the export notification requirements in 40 CFR part 707, 
subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for 
chemical substances that were the subject of PMNs. These proposed SNURs 
would require persons to notify EPA at least 90 days before commencing 
the manufacture or processing of a chemical substance for any activity 
proposed as a significant new use. Receipt of such notices would allow 
EPA to assess risks that may be presented by the intended uses and, if 
appropriate, to regulate the proposed use before it occurs. Additional 
rationale and background to these proposed rules are more fully set out 
in the preamble to EPA's first direct final SNUR published in the 
Federal Register issue of April 24, 1990 (55 FR 17376). Consult that 
preamble for further information on the objectives, rationale, and 
procedures for SNURs and on the basis for significant new use 
designations, including provisions for developing test data.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA

[[Page 57635]]

furthermore prohibits such manufacturing or processing from commencing 
until EPA has conducted a review of the notice, made an appropriate 
determination on the notice, and taken such actions as are required in 
association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As 
described in Unit V., the general SNUR provisions are found at 40 CFR 
part 721, subpart A.

C. Applicability of General Provisions

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

III. Proposed 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.
    To preliminarily determine what would constitute a significant new 
use for the 66 chemical substances that are 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. Substances Subject to This Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for 66 chemical substances in 40 CFR part 721, subpart E. In this unit, 
EPA provides the following information for each chemical substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) Order.
     Information identified by EPA that would help characterize 
the potential health and/or environmental effects of the chemical 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by the SNUR. 
This information may include testing required in a TSCA section 5(e) 
Order to be conducted by the PMN submitter, as well as testing not 
required to be conducted but which would also help characterize the 
potential health and/or environmental effects of the PMN substance. Any 
recommendation for information identified by EPA was made based on 
EPA's consideration of available screening-level data, if any, as well 
as other available information on appropriate testing for the chemical 
substance. Further, any such testing identified by EPA that includes 
testing on vertebrates was made after consideration of available 
toxicity information, computational toxicology and bioinformatics, and 
high-throughput screening methods and their prediction models. EPA also 
recognizes that whether testing/further information is needed will 
depend on the specific exposure and use scenario in the SNUN. EPA 
encourages all SNUN submitters to contact EPA to discuss any potential 
future testing. See Unit VII. for more information.
     CFR citation assigned in the regulatory text section of 
the proposed rule.
    The regulatory text section of each proposed rule specifies the 
activities that would be designated as significant new uses. Certain 
new uses, including exceedance of production volume limits (i.e., 
limits on manufacture volume) and other uses designated in this 
proposed rule, may be claimed as CBI.
    These proposed rules include 66 PMN substances that are subject to 
Orders issued under TSCA section 5(e)(1)(A) or section 5(f)(3)(A). Each 
Order is based on one or more of the findings in TSCA section 
5(a)(3)(A) or section 5(a)(3)(B): There is insufficient information to 
permit a reasoned evaluation; in the absence of sufficient information 
to permit a reasoned evaluation, the activities associated with the PMN 
substances may present unreasonable risk to health or the environment; 
the substance is or will be produced in substantial quantities, and 
enters or may reasonably be anticipated to enter the environment in 
substantial quantities or there is or may be significant (substantial) 
human exposure to the substance; presents an unreasonable risk of 
injury to health or environment. Those Orders require protective 
measures to limit exposures or otherwise mitigate the potential 
unreasonable risk. The proposed SNURs would 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).
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) Order usually requires, among other 
things, that potentially exposed employees wear specified respirators 
unless actual measurements of the workplace air show that air-borne 
concentrations of the PMN substance are below a New Chemical Exposure 
Limit (NCEL) that is established by EPA to provide adequate protection 
to human health. In addition to the actual NCEL concentration, the 
comprehensive NCELs provisions in TSCA section 5(e) Orders, which are 
modeled after Occupational Safety and Health Administration (OSHA) 
Permissible Exposure Limits (PELs) provisions, include requirements 
addressing performance criteria for sampling and analytical methods, 
periodic monitoring, respiratory protection, and recordkeeping.

[[Page 57636]]

However, no comparable NCEL provisions currently exist in 40 CFR part 
721, subpart B, for SNURs. Therefore, for these cases, the individual 
SNURs in 40 CFR part 721, subpart E, will state that persons subject to 
the SNUR who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under Sec.  721.30. EPA 
expects that persons whose Sec.  721.30 requests to use the NCELs 
approach for SNURs that are approved by EPA will be required to comply 
with NCELs provisions that are comparable to those contained in the 
corresponding TSCA section 5(e) Order for the same chemical substance.

PMN Number: P-15-106

    Chemical Name: Alkene reaction and distillation by-products and 
residues (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: May 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a mining and fuel 
additive. Based on test data for analogous chemicals, EPA identified 
concerns for developmental toxicity, irritation to the eyes, mucous 
membranes, and lungs, and dermal sensitization. EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 1 part per 
billion (ppb). The Order was issued under sections 5(a)(3)(B)(ii)(I) 
and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding that in the absence 
of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to health and the 
environment. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance either enters or may reasonably be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Order requires:
    1. Submit to EPA certain toxicity testing before manufacturing the 
confidential aggregate production volume specified in the Order;
    2. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    3. Use of a National Institute of Occupational Safety and Health 
(NIOSH) certified respirator with an assigned protection factor (APF) 
of 10 where there is a potential for inhalation exposure or compliance 
with a NCEL of 2 mg/m\3\ as an 8-hour time-weighted average to prevent 
inhalation exposure;
    4. Release of the PMN substance to water without resulting in 
surface water concentrations that exceed 1 ppb; and
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the Safety Data Sheet (SDS).
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be that would be designated 
by this proposed SNUR. The submitter has agreed not to exceed a certain 
production volume limit without performing specific developmental 
toxicity testing. EPA has also determined that the results of acute 
aquatic toxicity testing would help characterize the potential 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11194.

PMN Number: P-15-726

    Chemical name: Oxirane, 2-methyl-, polymer with oxirane, monobutyl 
ether, monoether with propylene oxide-2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane polymer.
    CAS Number: 1644400-33-8.
    Effective date of TSCA section 5(e) Order: March 7, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a co-polymer for use in adhesives and sealant 
formulations. Based on the reactivity of the triethoxysilyl group of 
the PMN substance, EPA identified concerns for respiratory irritation. 
The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(l)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to health and the environment. To 
protect against these risks, the Order requires:
    1. No manufacturing, processing, or use of the PMN substance in any 
manner that generates a vapor, dust, mist, or aerosol; and
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use designated by this SNUR. EPA has also determined 
that the results of specific target organ toxicity or pulmonary effects 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this testing, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citations: 40 CFR 721.11195.

PMN Number: P-16-337

    Chemical name: Aliphatic acrylate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a monomer. Based on analogy to acrylates, EPA 
has identified concerns for mutagenicity, oncogenicity, developmental, 
liver, and kidney toxicity, sensitization, irritation/corrosion, and 
aquatic/terrestrial toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to health and the 
environment. To protect against these risks, the Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure;
    3. No use of the PMN substance other than as a chemical 
intermediate;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    5. No release of the PMN substance resulting in surface water 
concentrations that exceed 1 ppb.

[[Page 57637]]

    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has also determined that the results of specific 
pulmonary effects and skin sensitization testing would help 
characterize the potential health effects of the PMN substance and 
results of chronic aquatic toxicity testing would help characterize the 
potential environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citation: 40 CFR 721.11196.

PMN Number: P-16-421

    Chemical name: Flue dust, glass manufg. Desulfurization. 
Definition: The dust produced from the flue gas exhaust cleaning of a 
glass manufacturing process using carbonate containing substances. It 
consists primarily of Na2S04, Na2CO3, and Na4(SO4)(CO3).
    CAS Number: 1916486-36-6.
    Effective date of TSCA section 5(e) Order: April 19, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the PMN substance will be as an additive to facilitate melting of sand 
during manufacture of glass. EPA identified concerns for reproductive, 
developmental, renal, neurological, hematological, gastrointestinal, 
and cardiovascular effects, and cancer, based on the substance 
containing toxic metal impurities. The Order was issued under sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health. To protect against these risks, the Order requires:
    1. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure or when the PMN 
substance is in a mixture at a concentration below 1.0 percent by 
weight, an APF of 10;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Not modifying the processes or uses described in the PMN such 
that occupational exposure is increased;
    4. Use of the PMN substance only as a site-limited intermediate;
    5. Conducting and reporting to EPA an elemental analysis for the 
composition of the PMN substance six months after filing the notice of 
commencement and every six months, at each use site, for three years 
thereafter; and
    6. Conducting and reporting to EPA an elemental analysis each time 
a change in the manufacturing process could result in the PMN substance 
possessing a different elemental composition.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of protective measures 1, 2, 3, 4, and manufacture of the 
substance with an elemental composition different from that described 
in the PMN.
    Potentially useful information: EPA has determined that certain 
information about the composition of the PMN substance may be 
potentially useful to characterize the health effects of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. The submitter has agreed not to manufacture the PMN 
substance more than 6 months without performing an elemental analysis 
to characterize the elemental composition of the PMN substance.
    CFR citation: 40 CFR 721.11197.

PMN Number: P-16-600

    Chemical name: Organo-titanate (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: May 23, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an electrolyte. 
Based on submitted test data and the pH of the PMN substance, EPA 
identified concerns for mutagenicity, sensitization, irritation to 
skin, eyes and mucous membranes, and oncogenicity. EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
35 ppb based on analogy to phenols. The Order was issued under sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
human health and the environment. To protect against these risks, the 
Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Manufacturing, processing, or use of the PMN substance only for 
the confidential use specified in the Order;
    4. No processing or use of the PMN substance in application methods 
that generate a vapor, mist, or aerosol; and
    5. No release of the PMN substance to surface waters.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information. EPA has determined that certain 
information about the health and environmental effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has also determined that the results of specific 
aquatic toxicity and carcinogenicity tests would help characterize the 
potential environmental and health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or other information.
    CFR citation: 40 CFR 721.11198.

PMN Number: P-17-7

    Chemical name: Dialkyl 7,10-dioxa, dithiahexadeca diene (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 17, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a chemical intermediate. Based on physical 
chemical properties and that the epoxide may occur as an oxidation 
product, EPA has concerns for skin and lung sensitization, 
mutagenicity, oncogenicity, developmental toxicity, male reproductive 
toxicity, liver toxicity, and kidney toxicity. Based on structure 
activity relationship (SAR) analysis on analogous neutral organic 
chemicals, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 67 ppb. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence

[[Page 57638]]

of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the Order 
requires:
    1. Use of personal protective equipment where there is a potential 
for dermal exposure;
    2. Refrain from manufacturing (including import) the PMN substance 
for use other than as a chemical intermediate;
    3. No manufacturing, processing or use of the substance that would 
result in inhalation exposures by vapor, dust, mist, or aerosol;
    4. No release of the PMN substance resulting in surface water 
concentrations that exceed 67 ppb; and
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about environmental effects and health effects of the PMN 
substance may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has determined that the results 
of specific target organ toxicity, carcinogenicity, and acute aquatic 
toxicity testing would help characterize the potential human and 
environmental effects of the PMN substance. Although the Order does not 
require these tests, the Order's restrictions remain in effect until 
the Order is modified or revoked by EPA based on submission of this or 
relevant information.
    CFR citation: 40 CFR 721.11199.

PMN Number: P-17-49

    Chemical name: Haloalkyl substituted carbomonocycle (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: March 13, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a starting material 
for synthesis. EPA has identified concerns for dermal and respiratory 
sensitization, mutagenicity, oncogenicity, and developmental toxicity 
based on the potential for the chemical substance to be an alkylating 
agent. There are also concerns for possible effects on the liver and 
the chemical substance is expected to be a strong irritant and 
corrosive to all exposed tissues based on data on analogous chemicals. 
EPA predicts that the substance will persist in the environment, could 
bioaccumulate or biomagnify, and could be toxic (PBT). The Order was 
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to health and the environment. To protect against these 
risks, the Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    2. Use of a NIOSH certified respirator with an APF of at least 10 
where there is potential for inhalation exposure;
    3. Use of the confidential engineering controls specified in the 
Order;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    5. Refraining from domestic manufacture in the United States (i.e., 
import only);
    6. Use of the PMN substance only for the confidential use specified 
in the Order;
    7. No manufacture of the PMN substance beyond an annual production 
volume specified in the Order;
    8. Disposal of the PMN substance only by incineration; and
    9. No release of the PMN substance to surface waters.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the fate and health effects of the PMN substance may 
be potentially useful to characterize the effects of the PMN substance 
in support of a request by the PMN submitter to modify the Order, or if 
a manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific reproductive/
developmental toxicity, genetic toxicity, and fate testing would help 
characterize the potential human and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11200.

PMN Numbers: P-17-249, P-17-380, and P-17-381

    Chemical names: Amine- and hydroxy-functional acrylic polymer, 
neutralized (P-17-249), amine- and hydroxy-functional acrylic polymer 
(generic) (P-17-380), and hydroxy acrylic polymer, methanesulfonates 
(generic) (P-17-381).
    CAS Numbers: Not available.
    Effective date of TSCA section 5(e) Order: March 6, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the generic 
(non-confidential) use of the PMN substances will be open and non-
dispersive. Based on analysis of test data on analogous polycationic 
polymers, EPA identified potential concerns for lung effects and 
aquatic toxicity. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to human health 
and the environment. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substances are or will be produced in substantial quantities and that 
the substances either enters or may reasonably be anticipated to enter 
the environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substances. To 
protect against these risks, the Order requires:
    1. Use of the PMN substances only for the confidential uses 
specified in the Order;
    2. Use of the confidential engineering controls specified in the 
Order;
    3. No manufacturing or use of the PMN substances with methods that 
generate a dust, spray, mist, or aerosol;
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS; and
    5. Disposal of the PMN substances only by incineration or with 
onsite pre-treatment of water releases at an onsite waste water 
treatment plant with at least 96% efficiency.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information. EPA has determined that certain 
information about the physical-chemical properties, health effects and 
environmental effects of the PMN substances may be potentially useful 
to characterize the potential effects of the PMN substances in support 
of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is

[[Page 57639]]

considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has also determined that the 
results of specific particle size distribution, physical-chemical 
property, acute and chronic pulmonary toxicity, and acute and chronic 
aquatic toxicity testing would help characterize the potential human 
and environmental effects of the PMN substances. Although the Order 
does not require these tests, the Order's restrictions will remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citation: 40 CFR 721.11201 (P-17-249), 40 CFR 721.11202 (P-17-
380) and 40 CFR 721.11203 (P-17-381).

PMN Number: P-17-270

    Chemical name: Alkyl perfluorinated acryloyl ester (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a low refractive 
index coating. Based analysis of test data on an analogue, EPA 
identified concerns for liver toxicity, blood toxicity, and male 
reproductive toxicity for the potential degradant product. EPA predicts 
environmental toxicity from the effects of the potential degradation 
products based on analogue test data. EPA predicts that the substance 
will persist in the environment, could bioaccumulate or biomagnify, and 
could be toxic (PBT). The Order was issued under sections 
5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health and the environment. To protect against these risks, the Order 
requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. No manufacture of the PMN substance beyond a confidential 
maximum annual manufacture (which includes import) volume; and
    3. Use the PMN substance only for the confidential uses specified 
in the Order. The proposed SNUR would designate as a ``significant new 
use'' the absence of these protective measures.
     Potentially useful information. EPA has determined that certain 
information about the environmental fate of the PMN substance may be 
potentially useful to characterize the potential effects of the PMN 
substance in support of a request by the PMN submitter to modify the 
Order, or if a manufacturer or processor is considering submitting a 
SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has also determined that the results of specific 
characterization, fate, and bioaccumulation testing would help 
characterize the potential health and environmental effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions will remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citations: 40 CFR 721.11204.

PMN Number: P-17-271

    Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-2-
propen-1-yl)-.omega.-hydroxy-.
    CAS Number: 31497-33-3.
    Effective date of TSCA section 5(e) Order: March 15, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a polymer intermediate. Based on the 
surfactant properties of the PMN substance, EPA has identified concerns 
for lung toxicity. There are concerns for skin and lung sensitization, 
mutagenicity, oncogenicity, developmental toxicity, male reproductive 
toxicity, liver toxicity, and kidney toxicity based on the potential 
epoxide oxidation product. The Order was issued under TSCA sections 
5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available 
information is insufficient to permit a reasoned evaluation of the 
human health effects of the PMN substance. To protect against these 
risks, the Order requires:
    1. Refrain from manufacturing, processing or using the PMN 
substance in a manner that generates a vapor, mist, or aerosol, or that 
results in inhalation exposure;
    2. Refraining from domestic manufacture in the United States (i.e., 
import only);
    3. No use of the PMN substance other than as a polymer 
intermediate; and
    4. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific genetic toxicology, 
reproductive/developmental toxicity and pulmonary effect testing would 
help characterize the potential health effects of the PMN substance. 
Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11205.

PMN Number: P-17-304

    Chemical name: Alkylidene dicarbomonocycle, polymer with halo-
substituted heteromonocycle and disubstituted alkyl carbomonocycle 
alkenedioate alkylalkenoate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: March 20, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a chemical intermediate for thermoset plastic 
material. Based on analogue data for low molecular weight moieties in 
the polymer, EPA has identified concern for sensitization. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to health and the environment. To protect against these 
risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Use of personal protective equipment to prevent dermal exposure 
where there is potential for dermal exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Not manufacture (which under TSCA includes importing) the PMN 
substance to contain no more than 0.1% residual isocyanate by weight; 
and
    5. No use of the PMN substance other than as a chemical 
intermediate for thermoset plastic material.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or

[[Page 57640]]

if a manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific skin sensitization 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11206.

PMN Numbers: P-17-337 and P-17-338

    Chemical names: Aluminum boron cobalt lithium nickel oxide (P-17-
337) and Aluminum boron cobalt lithium magnesium nickel oxide (P-17-
338).
    CAS Numbers: 207803-51-8 (P-17-337) and 2087499-33-8 (P-17-338).
    Effective date of TSCA section 5(e) Order: March 5, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that use of the 
substances will be as cathode material for lithium ion batteries. Based 
on analysis of test data on the PMN substances and analysis of test 
data on analogous chemicals, EPA identified concerns for lung effects, 
oncogenicity, systemic effects, dermal corrosion and irritation. The 
Order was issued under sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) 
of TSCA, based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to health. The Order was also issued 
under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on 
a finding that the PMN substance P-17-337 is or will be produced in 
substantial quantities and that the substance either enters or may 
reasonably be anticipated to enter the environment in substantial 
quantities, or there is or may be significant (or substantial) human 
exposure to the substance. To protect against these risks, the Order 
requires:
    1. Submit to EPA certain toxicity testing before exceeding the 24-
month and 6-year time limit specified in the Order;
    2. Use of personal protective equipment where there is a potential 
for dermal exposure;
    3. Use of a NIOSH certified respirator with an APF of at least 
1,000 where there is a potential for inhalation exposure;
    4. As an alternative to using respirators maintain workplace 
airborne concentrations of the PMN substances at or below a specified 
NCEL of 0.000092 mg/m\3\, verified by actual exposure monitoring data;
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    6. Manufacture and process the PMN substances only in a facility 
where all process air streams containing the PMN substances pass 
through control technology (such as a high-efficiency particulate air 
(HEPA) filter) with a rated removal efficiency of at least 99.99%.
    7. Dispose of the PMN substances and manufacture, processing, and 
use waste streams containing the PMN substances by landfill or by metal 
reclamation by a person who agrees to follow the terms of the Order.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures. Potentially useful information: 
EPA has determined that certain information about the health effects of 
the PMN substance may be potentially useful to characterize the effects 
of the PMN substance in support of a request by the PMN submitter to 
modify the Order, or if a manufacturer or processor is considering 
submitting a SNUN for a significant new use that would be designated by 
this proposed SNUR. The submitter has agreed not to exceed certain time 
limits without performing specific target organ toxicity or 
carcinogenic effects testing. The Order's restrictions remain in effect 
until the Order is modified or revoked by EPA based on submission of 
this or relevant information.
    CFR citation: 40 CFR 721.11207 (P-17-337) and 40 CFR 721.11208 (P-
17-338).

PMN Number: P-17-343

    Chemical name: Heteropolycyclic-alkanol carbomonocycle-
alkanesulfonate (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 3, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a corrosion 
inhibitor in aqueous systems. Based on test data on the PMN substance 
and SAR analysis of analogue data, EPA has identified hazards for eye 
irritation, developmental toxicity, systemic toxicity, and aquatic 
toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) 
and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of 
sufficient information to permit a reasoned evaluation, the substance 
may present an unreasonable risk of injury to health and the 
environment. The Order was also issued under TSCA sections 
5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the 
substance is or will be produced in substantial quantities and that the 
substance either enters or may reasonably be anticipated to enter the 
environment in substantial quantities, or there is or may be 
significant (or substantial) human exposure to the substance. To 
protect against these risks, the Order requires:
    1. Provide personal protective equipment to its workers to prevent 
dermal exposure where there is potential for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Use of the PMN substance only for the confidential use specified 
in the PMN; and
    4. Refrain from manufacturing, processing, or using the PMN 
substance in a manner that results in inhalation exposure to vapors, 
dusts, mists or aerosols.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health and environmental effects of the PMN 
substance may be potentially useful to characterize the effects of the 
PMN substance in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this 
proposed SNUR. EPA has also determined that the results of specific 
reproductive/developmental toxicity and chronic aquatic toxicity 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require these tests, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11209.

PMN Number: P-17-354

    Chemical name: (Substituted-dialkyl(C=1~7)silyl)alkanenitrile 
(generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: March 14, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as a solvent in 
electrolyte solution in batteries which will improve the performance of 
the batteries in consumer electronics and automotive applications. 
Based on test data on the PMN substance and SAR analysis of test data 
on analogous substances, EPA

[[Page 57641]]

identified hazard for mutagenicity, eye and skin irritation, 
sensitization, kidney toxicity, reproductive toxicity, developmental 
toxicity, and aquatic toxicity. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence of sufficient information to permit a reasoned 
evaluation, the substance may present an unreasonable risk of injury to 
health and the environment. To protect against these risks, the Order 
requires:
    1. Provide personal protective equipment to its workers to prevent 
dermal exposure where there is potential for dermal exposure;
    2. Use of a NIOSH-certified respirator with an APF of at least 50 
to prevent inhalation exposure where there is potential for inhalation 
exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Use of the PMN substance only for the confidential use specified 
in the Order; and
    5. Dispose of the PMN substance only by incineration with an 
efficiency not less than 99.9%.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific reproductive toxicity 
testing would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this test, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11210.

PMN Number: P-17-361

    Chemical name: Substituted heteromonocycle, polymer with 
diisocyanato alkane and alkanediol, substituted heteromonocycle 
homopolymer ester with substituted alkylacrylate; blocked (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 26, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a dual-cure adhesion coating or barrier. EPA 
identified concerns for eye and skin irritation, and dermal and 
respiratory sensitization based on the isocyanate moiety. EPA also 
identified concerns for liver, kidney, and developmental toxicities, 
oncogenicity, and mutagenicity based on the presence of acrylates. The 
Order was issued under sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) 
of TSCA, based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substance may present 
an unreasonable risk of injury to human health. To protect against 
these risks, the Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    2. Use of a NIOSH-certified respirator with an APF of 50 or an APF 
of 1000 if spray applied where there is a potential for inhalation 
exposure;
    3. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    4. Refraining from domestic manufacture in the United States (i.e., 
import only);
    5. Not manufacturing (which under TSCA includes import) the PMN 
substance with more than 0.25% residual isocyanate;
    6. Manufacture (which under TSCA includes import) the PMN substance 
to have a number average molecular weight of greater than or equal to 
2,280 Daltons (weight percent); and
    7. Use the PMN substance only as a dual-cure adhesion coating or 
barrier.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of skin sensitization testing 
would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this testing, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11211.

PMN Numbers: P-17-401 and P-17-402

    Chemical names: Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, sodium salts (P-17-401) and Glycolipids, sophorose-contg., 
candida bombicola-fermented, from C16-18 and C18-unsatd. glycerides and 
D-glucose, hydrolyzed, potassium salts (P-17-402).
    CAS Numbers: 2102535-74-8 (P-17-401) and 2102536-64-9 (P-17-402).
    Effective date of TSCA section 5(e) Order: April 19, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of 
the substances will be as a flow-back additive, surfactant for enhanced 
oil recovery, and foaming agent for well deliquification. Based on 
physical/chemical properties of the PMN substances, and analysis of 
test data on the PMN substances, EPA has identified concern for 
irritation to eyes, skin, mucous membranes and lungs. There is also 
concern for lung effects if respirable particulates or droplets are 
inhaled. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the substances may present 
an unreasonable risk of injury to health and the environment. The Order 
was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 
5(e)(1)(A)(ii)(II), based on a finding that the substances are or will 
be produced in substantial quantities and that the substances either 
enter or may reasonably be anticipated to enter the environment in 
substantial quantities, or there is or may be significant (or 
substantial) human exposure to the substances. To protect against these 
risks, the Order requires:
    1. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    3. Refrain from manufacturing (excluding import) of the PMN 
substances in the United States;
    4. Refrain from manufacturing (including import), processing, or 
using the PMN substances in a manner that would generate vapors, mists, 
aerosols or dusts; and
    5. Refrain from manufacturing, processing, or using the PMN 
substances for consumer use or for commercial uses that could introduce 
the substance into a consumer setting.

[[Page 57642]]

    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties, environmental 
effects, and health effects of the PMN substances may be potentially 
useful to characterize the effects of the PMN substances in support of 
a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific physical-chemical 
property acute aquatic toxicity, and acute and chronic pulmonary 
effects testing would help characterize the potential health effects of 
the PMN substances. Although the Order does not require this testing, 
the Order's restrictions remain in effect until the Order is modified 
or revoked by EPA based on submission of this or relevant information.
    CFR citations: 40 CFR 721.11212 (P-17-401) and 40 CFR 721.11213 (P-
17-402).

PMN Number: P-17-404

    Chemical name: 2-Propenoic acid, 2-methyl-, 2-(2-butoxyethoxy)ethyl 
ester, polymer with 1,3-butadiene and 2-propenenitrile.
    CAS number: 2058302-39-7.
    Effective date of TSCA section 5(e) Order: March 27, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the generic 
(non-confidential) use of the substance will be as an intermediate 
completely used on site. Based on SAR analysis of test data on 
analogous high molecular weight polymers, EPA has identified concerns 
for lung effects. The Order was issued under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against this risk, the Order requires: No manufacturing, 
processing, or use of the PMN substance in any manner that generate a 
spray, mist, aerosol, or respirable particles.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of this protective measure.
    Potentially useful information: EPA has determined that certain 
information about the physical-chemical properties and health effects 
of the PMN substance may be potentially useful to characterize the 
effects of the PMN substance in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has also determined that the 
results of particle size testing and acute and chronic pulmonary 
effects testing would help characterize the potential health effects of 
the PMN substance. Although the Order does not require these tests, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11214.

PMN Numbers: P-17-405, P-17-406, P-17-407, P-17-408, P-17-409, P-17-
410, P-17-411, P-17-412, P-17-414, P-17-415, P-17-416, P-17-417, P-17-
418, P-17-420, P-17-421, P-17-422, P-17-423, P-17-441, P-17-442, P-17-
444, P-17-445, P-17-446, P-17-447, P-17-448, P-17-449, P-17-450

    Chemical names and CAS Numbers:

------------------------------------------------------------------------
               Chemical names                          CAS No.
------------------------------------------------------------------------
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 405).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 406).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 407).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 408).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 409).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 410).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 411).
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 412).
Halogenated benzoic acid (P-17-414)........  Not available.
Halogenated benzoic acid (P-17-415)........  Not available.
Halogenated benzoic acid (P-17-416)........  Not available.
Halogenated benzoic acid (P-17-417)........  Not available.
Halogenated benzoic acid (P-17-418)........  Not available.
Halogenated benzoic acid (P-17-420)........  Not available.
Halogenated benzoic acid (P-17-421)........  Not available.
Halogenated benzoic acid (P-17-422)........  Not available.
Halogenated benzoic acid ethyl ester (P-17-  Not available.
 423).
Halogenated sodium benzoate (P-17-441).....  Not available.
Halogenated sodium benzoate (P-17-442).....  Not available.
Halogenated sodium benzoate (P-17-444).....  Not available.
Halogenated sodium benzoate (P-17-445).....  Not available.
Halogenated sodium benzoate (P-17-446).....  Not available.
Halogenated sodium benzoate (P-17-447).....  Not available.
Halogenated sodium benzoate (P-17-448).....  Not available.
Halogenated sodium benzoate (P-17-449).....  Not available.
Halogenated benzoic acid (P-17-450)........  Not available.
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: May 17, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state that the use of 
the substances is for oil and gas well performance or monitoring well 
performance. Based on test data for a structurally analogous chemical 
and physical/chemical properties, EPA has identified concerns for 
reproductive toxicity, developmental toxicity, and neurotoxicity 
(ataxia), lung effects, and skin irritation. Based on SAR analysis for 
analogous chemicals, predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 8 ppb for certain PMN substances and 460 
ppb for certain other PMN substances. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding 
that in the absence

[[Page 57643]]

of sufficient information to permit a reasoned evaluation, the 
substances may present an unreasonable risk of injury to health and 
environment. To protect against these risks, the Order requires:
    1. Refrain from using the PMN substances other than for oil and gas 
well performance or monitoring well performance;
    2. Submit to EPA certain toxicity testing before exceeding the 
specified confidential production volume limits in the Order;
    3. No manufacture of the PMN substances beyond an annual 
confidential production volume specified in the Order;
    4. Use of personal protective equipment to prevent dermal exposure 
where there is a potential for dermal exposure;
    5. Use of engineering controls as specified in the Order;
    6. Use of a NIOSH certified respirator with an APF of 50 where 
there is a potential for inhalation exposure or compliance with a NCEL 
of 0.0184 mg/m\3\ as an 8-hour time-weighted average to prevent 
inhalation exposure for P-17-414 to 418, P-17-420 to 422, and P-17-450;
    7. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS;
    8. Limit the amount of the PMN substances handled at processing and 
use sites as specified in the Order;
    9. Limit manufacturing and use to liquid formulations for P-17-441 
to 442 and P-17- 444 to 449;
    10. No release of P-17-405 to 412 and P-17-0423 resulting in 
surface water concentrations that exceed 8 ppb; and
    11. No release of P-17-414 to 418, P-17-420-422, P-17-441 to 442 
and P-17-444 to 450 resulting in surface water concentrations that 
exceed 460 ppb.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the environmental and health effects of the PMN 
substances may be potentially useful to characterize the effects of the 
PMN substances in support of a request by the PMN submitter to modify 
the Order, or if a manufacturer or processor is considering submitting 
a SNUN for a significant new use that would be designated by this 
proposed SNUR. The submitter has agreed not to exceed the specified 
production volume limits without performing specific reproductive/
developmental toxicity testing, pulmonary effect testing and acute 
aquatic toxicity testing for certain PMN substances. EPA has also 
determined that the results of additional reproductive/developmental 
and pulmonary effects testing would help characterize the potential 
health effects of the PMN substance. The Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citation: 40 CFR 721.11215 (P-17-405, P-17-406, P-17-407, P-17-
408, P-17-409, P-17-410, P-17-411, P-17-412, P-17-423) and 40 CFR 
721.11216 (P-17-414, P-17-415, P-17-416, P-17-417, P-17-418, P-17-420, 
P-17-421, P-17-422, P-17-441, P-17-442, P-17-444, P-17-445, P-17-446, 
P-17-447, P-17-448, P-17-449, P-17-450).

PMN Numbers: P-17-424, P-17-425, P-17-426, P-17-427, P-17-428, P-17-
429, P-17-430, P-17-431, P-17-432, P-17-433, P-17-435, P-17-436, P-17-
437, P-17-438, P-17-439, and P-17-440

    Chemical names and CAS Numbers:

------------------------------------------------------------------------
                    Chemical name                           CAS No.
------------------------------------------------------------------------
Benzoic acid, 2-chloro-3-methyl-, sodium salt (1:1)         1708942-16-8
 (P-17-424).........................................
Benzoic acid, 3-chloro-2-methyl-, sodium salt (1:1)         1708942-17-9
 (P-17-425).........................................
Benzoic acid, 3-chloro-4-methyl-, sodium salt (1:1)         1708942-15-7
 (P-17-426).........................................
Benzoic acid, 2-chloro-5-methyl-, sodium salt (1:1)          118537-88-5
 (P-17-427).........................................
Benzoic acid, 4-chloro-2-methyl-, sodium salt (1:1)          203261-42-1
 (P-17-428).........................................
Benzoic acid, 3-fluoro-2-methyl-, sodium salt (1:1)         1708942-24-8
 (P-17-429).........................................
Benzoic acid, 3-fluoro-4-methyl-, sodium salt (1:1)         1805805-74-6
 (P-17-430).........................................
Benzoic acid, 4-fluoro-2-methyl-, sodium salt (1:1)         1708942-23-7
 (P-17-431).........................................
Benzoic acid, 2-fluoro-4-methyl-, sodium salt (1:1)         1708942-19-1
 (P-17-432).........................................
Benzoic acid, 2-fluoro-3-methyl-, sodium salt (1:1)         1708942-18-0
 (P-17-433).........................................
Benzoic acid, 2-fluoro-3-(trifluoromethyl)-, sodium         1701446-41-4
 salt (1:1) (P-17-435)..............................
Benzoic acid, 2-fluoro-4-(trifluoromethyl)-, sodium         1708942-20-4
 salt (1:1) (P-17-436)..............................
Benzoic acid, 2-fluoro-6-(trifluoromethyl)-, sodium         1708942-21-5
 salt (1:1) (P-17-437)..............................
Benzoic acid, 3-fluoro-5-(trifluoromethyl)-, sodium         1535169-59-5
 salt (1:1) (P-17-438)..............................
Benzoic acid, 4-fluoro-3-(trifluoromethyl)-, sodium         1701446-39-0
 salt (1:1) (P-17-439)..............................
Benzoic acid, 4-fluoro-2-(trifluoromethyl)-, sodium         1708942-22-6
 salt (1:1) (P-17-440)..............................
------------------------------------------------------------------------

    Effective date of TSCA section 5(e) Order: May 7, 2018.
    Basis for TSCA section 5(e) Order: The PMNs state the use of the 
substances will be as tracer chemicals used as a tracer in water 
solution, or in a solid blend with polymer, or in a solid proppant bead 
form to measure flow in deep oil-bearing or gas-bearing strata. Based 
on test data for an analogous chemical, and physical/chemical 
properties, EPA has identified toxicity concerns for reproductive 
toxicity, developmental toxicity, neurotoxicity (ataxia), lung effects, 
and skin irritation. Based on SAR analysis of test data, EPA identified 
ecotoxicity hazards at concentrations that exceed 300 ppb. The Order 
was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), 
based on a finding that in the absence of sufficient information to 
permit a reasoned evaluation, the substance may present an unreasonable 
risk of injury to health and the environment. To protect against these 
risks, the Order requires:
    1. Refrain from manufacturing (excluding import) the PMN substances 
in the United States;
    2. Refrain from using the PMN substances other than as tracers in 
aqueous solution, or in a solid blend with polymer, or in a solid 
proppant bead form to measure flow in deep oil-bearing or gas-bearing 
strata;
    3. Limit the amount of the PMN substances handled at processing and 
use sites to no more than 50 kg/day/site in aggregate for the solid 
formulations that generate a dust;
    4. Provide personal protective equipment to its workers to mitigate 
dermal exposure to the PMN substances where there is potential for 
dermal exposure;
    5. Establishment and use of a hazard communication program, 
including

[[Page 57644]]

human health precautionary statements on each label and in the SDS; and
    6. No release of the PMN substances resulting in surface water 
concentrations that exceed 300 ppb;
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substances may be 
potentially useful to characterize the effects of the PMN substances in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has determined that the results of pulmonary effects, reproductive/
developmental toxicity testing and acute aquatic toxicity testing would 
help characterize the potential health and environmental effects of the 
PMN substances. Although the Order does not require this testing, the 
Order's restrictions remain in effect until the Order is modified or 
revoked by EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11217.

PMN Numbers: P-17-434 and P-17-443

    Chemical name: Benzoic acid, 2,3,6-trifluoro, sodium salt (1:1).
    CAS Number: 1803845-07-9.
    Effective date of TSCA section 5(e) Orders: May 11, 2018.
    Basis for TSCA section 5(e) Orders: PMN P-17-434 states that the 
use of the substance is as a tracer chemical (1) used as a tracer in 
water solution, (2) when in a solid blend with polymer, or (3) in a 
solid proppant bead form, all to measure flow in deep oil or gas 
bearing strata. PMN P-17-443 states that the generic (non-confidential) 
use of the substance will be to monitor well performance. Based on test 
data for a structurally analogous chemical and physical/chemical 
properties, EPA has identified concerns for reproductive toxicity, 
development toxicity, and neurotoxicity (ataxia), lung effects, and 
skin irritation. The Orders were issued for under TSCA sections 
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the 
absence of sufficient information to permit a reasoned evaluation, the 
substance may present an unreasonable risk of injury to human health. 
To protect against these risks, the Orders require:
    1. Submission of certain toxicity testing before exceeding the 
confidential production volume limit in the Order for P-17-443;
    2. Manufacture the PMN substance only as a liquid formulation with 
the engineering controls specified in the Order for P-17-443;
    3. Refrain from using the PMN substance other than as a tracer in 
aqueous solution, a solid blend with polymer, or a solid proppant bead 
form to measure flow in deep oil-bearing or gas-bearing strata (non-
confidential uses specified in the Order for P-17-434), or for the 
confidential use specified in the Order for P-17-443. The Order for P-
17-434 allows processing and use of solid forms of the PMN substance 
but no more than 50 kg/site/day for those forms that generate a dust. 
Other manufacturers and processors would need to submit a SNUN to 
manufacture or process solid forms of the PMN substance.
    4. Use of personal protective equipment to mitigate dermal exposure 
to the PMN substance where there is potential for dermal exposure; and
    5. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. The 
submitter for P-17-443 has agreed not to exceed a certain aggregated 
production volume limit without performing specific pulmonary effects 
testing. EPA has also determined that the results of pulmonary effects 
and reproductive/developmental toxicity testing would help characterize 
the potential health effects of the PMN substance. Although the Order 
does not require this testing, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or relevant information.
    CFR citations: 40 CFR 721.11218.

PMN Number: P-18-3

    Chemical name: Fatty acids, diesters with dihydroxyalkane, fatty 
acids, esters with dihydroxyalkane (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) Order: April 10, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be as a lubricant for metal working applications. 
Based on SAR analysis of test data on analogous esters, EPA has 
identified concerns for sensitization and skin and eye irritation. The 
Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient 
information to permit a reasoned evaluation, the PMN substance may 
present an unreasonable risk of injury to health and the environment. 
To protect against these risks, the Order requires:
    1. Provide personal protective equipment to its workers to prevent 
dermal exposure where there is potential for dermal exposure; and
    2. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about the health effects of the PMN substance may be 
potentially useful to characterize the effects of the PMN substance in 
support of a request by the PMN submitter to modify the Order, or if a 
manufacturer or processor is considering submitting a SNUN for a 
significant new use that would be designated by this proposed SNUR. EPA 
has also determined that the results of specific sensitization testing 
would help characterize the potential health effects of the PMN 
substance. Although the Order does not require this test, the Order's 
restrictions remain in effect until the Order is modified or revoked by 
EPA based on submission of this or relevant information.
    CFR citation: 40 CFR 721.11219.

PMN Number: P-18-22

    Chemical Name: Substituted carbomonocycle, polymer with halo 
substituted heteromonocycle and polyoxyalkylene polymer with 
alkylenebis (isocyanatocarbomonocycle) bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed (generic).
    CAS Number: Not available.
    Effective date of TSCA section 5(e) Order: April 20, 2018.
    Basis for TSCA section 5(e) Order: The PMN states that the use of 
the substance will be used as a primer coating used for corrosion 
protection. Based on the physical/chemical properties of the PMN 
substance, available PMN data, and comparing the substance to 
structurally analogous chemical substances, EPA identified concerns for 
dermal and ocular

[[Page 57645]]

irritation and sensitization for the low molecular weight fraction of 
the PMN substance. EPA also identified concerns for ecotoxicity if the 
substance was manufactured differently. The Order was issued under TSCA 
sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a 
finding that in the absence of sufficient information to permit a 
reasoned evaluation, the substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the Order requires:
    1. Refraining from domestic manufacture in the United States (i.e., 
import only);
    2. Use of the PMN substance only for primer coating for corrosion 
protection;
    3. Import the PMN substance with an average molecular weight 
greater than 1026 daltons and with low weight fractions no more than 
15.3% less than 500 daltons and 25% less than 1000 daltons;
    4. Use of personal protective equipment where there is a potential 
for dermal exposure;
    5. Use of a NIOSH-certified respirator with an APF of at least 50 
where there is a potential for inhalation exposure; and
    6. Establishment and use of a hazard communication program, 
including human health precautionary statements on each label and in 
the SDS.
    The proposed SNUR would designate as a ``significant new use'' the 
absence of these protective measures.
    Potentially useful information: EPA has determined that certain 
information about environmental effects and health effects of the PMN 
substance may be potentially useful in support of a request by the PMN 
submitter to modify the Order, or if a manufacturer or processor is 
considering submitting a SNUN for a significant new use that would be 
designated by this proposed SNUR. EPA has also determined that the 
results of skin sensitization, fate property testing, and acute and 
chronic aquatic toxicity testing would help characterize the potential 
human and environmental effects of the PMN substance. Although the 
Order does not require these tests, the Order's restrictions remain in 
effect until the Order is modified or revoked by EPA based on 
submission of this or other relevant information.
    CFR citation: 40 CFR 721.11220.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these proposed SNURs, EPA concluded that for all 66 
chemical substances regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) Orders requiring the use of 
appropriate exposure controls were negotiated with the PMN submitters. 
The proposed SNURs would 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).

B. Objectives

    EPA is proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA would receive notice of any person's intent to 
manufacture or process a listed chemical substance for the described 
significant new use before that activity begins.
     EPA would have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing a listed chemical substance for the described significant 
new use.
     EPA would be able to either determine that the prospective 
manufacture or processing is not likely to present an unreasonable 
risk, or to take necessary regulatory action associated with any other 
determination, before the described significant new use of the chemical 
substance occurs.
     EPA would 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.

VI. Applicability of the Proposed 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 proposed rule 
have undergone premanufacture review. In cases where EPA has not 
received a notice of commencement (NOC) and the chemical substance has 
not been added to the TSCA Inventory, no person may commence such 
activities without first submitting a PMN. Therefore, for chemical 
substances for which an NOC has not been submitted EPA concludes that 
the designated significant new uses are not ongoing.
    When chemical substances identified in this proposed rule are added 
to the TSCA Inventory, EPA recognizes that, before the rule is 
effective, other persons might engage in a use that has been identified 
as a significant new use. However, TSCA section 5(e) Orders have been 
issued for all of the chemical substances, and the PMN submitters are 
prohibited by the TSCA section 5(e) Orders from undertaking activities 
which would be designated as significant new uses. The identities of 42 
of the 66 chemical substances subject to this proposed rule have been 
claimed as confidential and EPA has not received any post-PMN bona fide 
submission (per Sec. Sec.  720.25 and 721.11) for a chemical substance 
covered by this action. Based on this, the Agency believes that it is 
highly unlikely that any of the significant new uses described in the 
regulatory text of this proposed rule are ongoing.
    Therefore, EPA designates November 15, 2018 as the cutoff date for 
determining whether the new use is ongoing. The objective of EPA's 
approach is to ensure that a person cannot defeat a SNUR by initiating 
a significant new use before the effective date of the final rule. In 
developing this proposed rule, EPA has recognized that, given EPA's 
general practice of posting proposed rules on its website a week or 
more in advance of Federal Register publication, this objective could 
be thwarted even before Federal Register publication of the proposed 
rule.
    Persons who begin commercial manufacture or processing of the 
chemical substances for a significant new use identified as of that 
date would have to cease any such activity upon the effective date of 
the final rule. To resume their activities, these persons would have to 
first comply with all applicable SNUR notification requirements and 
wait until EPA has conducted a review of the notice, made an 
appropriate determination on the

[[Page 57646]]

notice, and has taken such actions as are required with that 
determination.

VII. Development and Submission of Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular new information (e.g., generating test data) before 
submission of a SNUN. There is an exception: development of test data 
is required where the chemical substance subject to the SNUR is also 
subject to a rule, order or consent agreement under TSCA section 4 (see 
TSCA section 5(b)(1)).
    In the absence of a TSCA section 4 test rule covering the chemical 
substance, persons are required only to submit information in their 
possession or control and to describe any other information known to or 
reasonably ascertainable by them (see 40 CFR 720.50). However, upon 
review of PMNs and SNUNs, the Agency has the authority to require 
appropriate testing. Unit IV. lists potentially useful information 
identified by EPA that would help characterize the potential health 
and/or environmental effects of the PMN/SNUN substance for all of the 
listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have 
led to modifications in our approach to testing requirements, including 
an increased consideration of alternatives to vertebrate testing. 
Descriptions of tests/information needs are provided for informational 
purposes only and EPA strongly encourages persons, before performing 
any testing, to consult with the Agency pertaining to protocol 
selection. 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 potentially useful information. EPA encourages dialogue with Agency 
representatives to help determine how best the submitter can meet both 
the data needs and the objective of TSCA section 4(h). To access the 
OCSPP test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.'' The Organisation for Economic Co-operation and 
Development (OECD) test guidelines are available from the OECD Bookshop 
at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
    In certain of the TSCA section 5(e) Orders for the chemical 
substances that would be regulated under this proposed rule, EPA has 
established production limits in view of the lack of data on the 
potential health and environmental risks that may be posed by the 
significant new uses or increased exposure to the chemical substances. 
These limits cannot be exceeded unless the PMN submitter first submits 
the results of specified tests that would permit a reasoned evaluation 
of the potential risks posed by these chemical substances. Listings of 
the tests specified in the TSCA section 5(e) Orders are included in 
Unit IV. The proposed SNURs contain the same production limits as the 
TSCA section 5(e) Orders. Exceeding these production limits is defined 
as a significant new use. Persons who intend to exceed the production 
limit must notify the Agency by submitting a SNUN at least 90 days in 
advance of commencement of non-exempt commercial manufacture or 
processing 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.
    Any request by EPA for the testing described in the Orders was made 
based on EPA's consideration of available screening-level data, if any, 
as well as other available information on appropriate testing for the 
PMN substances. Further, any such testing/information request on the 
part of EPA that includes testing on vertebrates was made after 
consideration of available toxicity information, computational 
toxicology and bioinformatics, and high-throughput screening methods 
and their prediction models.
    The potentially useful information listed in Unit IV. may not be 
the only means of addressing the potential risks of the chemical 
substance. EPA recommends that potential SNUN submitters contact EPA 
early enough so that they will be able to conduct the appropriate 
tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which 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.

VIII. SNUN Submissions

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in Sec.  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 Sec.  720.40 and Sec.  721.25. E-PMN software is available 
electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this proposed rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2018-0650.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish 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, entitled ``Regulatory 
Planning and Review'' (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable.
    The information collection requirements related to this proposed 
rule have already been approved by OMB pursuant to PRA under OMB 
control number 2070-0012 (EPA ICR No. 574). This 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

[[Page 57647]]

respondent burden, including through the use of automated collection 
techniques, to the Director, Collection Strategies Division, Office of 
Environmental Information (2822T), Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember 
to include the OMB control number in any correspondence, but do not 
submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this proposed 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, and 14 in FY2017, 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 proposed 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 proposed rule would not impose any 
enforceable duty, contain any unfunded mandate, or otherwise have any 
effect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

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

G. Executive Order 13045

    This proposed rule is not subject to Executive Order 13045, 
entitled ``Protection of Children from Environmental Health Risks and 
Safety Risks'' (62 FR 19885, April 23, 1997), because this is not an 
economically significant regulatory action as defined by Executive 
Order 12866, and this action does not address environmental health or 
safety risks disproportionately affecting children.

H. Executive Order 13211

    This proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this proposed rule is not expected to affect energy supply, 
distribution, or use and because this proposed rule is not a 
significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

    This proposed rule does not entail special considerations of 
environmental justice related issues as delineated by Executive Order 
12898, entitled ``Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations'' (59 FR 7629, February 
16, 1994).

List of Subjects in 40 CFR Part 721

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

    Dated: October 24, 2018.
Jeffery T. Morris,
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. Amend Subpart E by adding Sec.  721.11194 through Sec.  721.11220 to 
read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
Sec.  721.11194 Alkene reaction and distillation by-products and 
residues (generic).
Sec.  721.11195 Oxirane, 2-methyl-, polymer with oxirane, monobutyl 
ether, monoether with propylene oxide-2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane polymer.
Sec.  721.11196 Aliphatic acrylate (generic).
Sec.  721.11197 Flue dust, glass manufg. Desulfurization. 
Definition: The dust produced from the flue gas exhaust cleaning of 
a glass manufacturing process using carbonate containing substances. 
It consists primarily of Na2S04, Na2CO3, and Na4(SO4)(CO3).
Sec.  721.11198 Organo-titanate (generic).
Sec.  721.11199 Dialkyl 7,10-dioxa, dithiahexadeca diene (generic).
Sec.  721.11200 Haloalkyl substituted carbomonocycle (generic).
Sec.  721.11201 Amine- and hydroxy-functional acrylic polymer, 
neutralized (generic).

[[Page 57648]]

Sec.  721.11202 Amine- and hydroxy-functional acrylic polymer 
(generic).
Sec.  721.11203 Hydroxy acrylic polymer, methanesulfonates 
(generic).
Sec.  721.11204 Alkyl perfluorinated acryloyl ester (generic).
Sec.  721.11205 Poly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-2-
propen-1-yl)-.omega.-hydroxy-.
Sec.  721.11206 Alkylidene dicarbomonocycle, polymer with halo-
substituted heteromonocycle and disubstituted alkyl carbomonocycle 
alkenedioate alkylalkenoate (generic).
Sec.  721.11207 Aluminum boron cobalt lithium nickel oxide.
Sec.  721.11208 Aluminum boron cobalt lithium magnesium nickel 
oxide.
Sec.  721.11209 Heteropolycyclic-alkanol carbomonocycle-
alkanesulfonate (generic).
Sec.  721.11210 (Substituted-dialkyl(C=1~7)silyl)alkanenitrile 
(generic).
Sec.  721.11211 Substituted heteromonocycle, polymer with 
diisocyanato alkane and alkanediol, substituted heteromonocycle 
homopolymer ester with substituted alkylacrylate; blocked (generic).
Sec.  721.11212 Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16- 18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, sodium salts.
Sec.  721.11213 Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16- 18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, potassium salts.
Sec.  721.11214 2-Propenoic acid, 2-methyl-, 2-(2-butoxyethoxy)ethyl 
ester, polymer with 1,3-butadiene and 2-propenenitrile.
Sec.  721.11215 Halogenated benzoic acid ethyl ester (generic).
Sec.  721.11216 Halogenated benzoic acid (generic).
Sec.  721.11217 Certain halogenated sodium benzoate salts.
Sec.  721.11218 Benzoic acid, 2, 3, 6-trifluoro, sodium salt (1:1).
Sec.  721.11219 Fatty acids, diesters with dihydroxyalkane, fatty 
acids, esters with dihydroxyalkane (generic).
Sec.  721.11220 Substituted carbomonocycle, polymer with halo 
substituted heteromonocycle and polyoxyalkylene polymer with 
alkylenebis (isocyanatocarbomonocycle) bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed, (generic).

Subpart E--Significant New Uses for Specific Chemical Substances

* * * * *

Sec.  721.11194  Alkene reaction and distillation by-products and 
residues (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkene 
reaction and distillation by-products and residues (P-15-106) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iii), (a)(3), (a)(4), (a)(5)(respirators must 
provide a National Institute for Occupational Safety and Health (NIOSH) 
assigned protection factor (APF) of at least 10), (when determining 
which persons are reasonable likely to be exposed as required for Sec.  
721.63 (a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposures, 
where feasible), (a)(6)(v), (vi), (b)(concentration set at 1.0%), and 
(c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL is 2 mg/m\3\ as an 
8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved].
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (ix), (g)(2)(i), (ii), (iv), (v), (use respiratory protection or 
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 2 mg/m\3\), (g)(3)(ii), (g)(4)(do not release to 
water at concentrations that exceed 1 ppb), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q).
    (iv) 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 (i), and (k) are applicable to manufacturers, 
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.  721.11195  Oxirane, 2-methyl-, polymer with oxirane, monobutyl 
ether, monoether with propylene oxide-2-[[3-
(triethoxysilyl)propoxy]methyl]oxirane polymer.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2-methyl-, 
polymer with oxirane, monobutyl ether, monoether with propylene oxide-
2-[[3-(triethoxysilyl)propoxy]methyl]oxirane polymer (P-15-726, CAS No. 
1644400-33-8) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this section do not apply to quantities of the 
substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e) (concentration set at 1.0%), (f), (g)(1)(ii), 
(2)(ii), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process, or use the substance in any manner that generates 
a vapor, dust, mist, or aerosol.
    (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 (f) through (i) are applicable to 
manufacturers, 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.  721.11196  Aliphatic acrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic acrylate (P-16-337) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section. The requirements of this section

[[Page 57649]]

do not apply to quantities of the substance after they have been 
reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified Sec.  
721.63(a)(1), (2)(i), (iii), (iv), (a)(3), (a)(4), (a)(5)(respirators 
must provide a National Institute for Occupational Safety and Health 
with assigned protection factor of at least 50), (when determining 
which persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (4), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure 
where feasible), (a)(6)(v), (vi), (particulate), (b)(concentration set 
at 0.1%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), (ii), 
(iv), (vii), (ix), (g)(2)(i), (ii), (iii), (iv), (v), (g)(3)(i), (ii), 
(g)(4)(release restrictions apply), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), (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 (i) and (k).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11197  Flue dust, glass manufg. Desulfurization. Definition: 
The dust produced from the flue gas exhaust cleaning of a glass 
manufacturing process using carbonate containing substances. It 
consists primarily of Na2S04, Na2CO3, and Na4(SO4)(CO3).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as flue dust, glass 
manufg. Desulfurization. Definition: The dust produced from the flue 
gas exhaust cleaning of a glass manufacturing process using carbonate 
containing substances. It consists primarily of Na2S04, Na2CO3, and 
Na4(SO4)(CO3) (P-16-421, CAS No. 1916486-36-6) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
incorporated into a glass product.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (4), (5)(respirators must provide a National 
Institute for Occupational Safety and Health assigned protection factor 
of at least 50 or when the PMN substance is in a mixture at a 
concentration below 1.0 percent by weight, an APF of 10), (when 
determining which persons are reasonable likely to be exposed as 
required for Sec.  721.63(a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible), (a)(6)(v), (vi), (particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(iii), (iv), (vi), (ix), 
(cardiovascular effects), (g)(2)(i), (ii), (iii), (iv), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(h). It is a significant new use to modify 
the processes or uses described in the premanufacture notice such that 
occupational exposure is increased. It is a significant new use to 
manufacture the substance with an elemental composition different from 
that described in the PMN.
    (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 (d) and (f) through (i) are applicable to 
manufacturers, 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.  721.11198  Organo-titanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organo-
titanate (P-16-600) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (3), (when determining which persons are reasonable 
likely to be exposed as required for Sec.  721.63(a)(1), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposures, where feasible), (a)(6)(particulate), 
(b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(vii), 
(g)(2)(i), (v), (g)(3)(ii), (g)(4)(iii), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to process 
or use the substance involving an application method that generates a 
vapor, mist, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph (b).
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (i) and (k) are applicable to manufacturers, 
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.  721.11199  Dialkyl 7,10-dioxa, dithiahexadeca diene (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as dialkyl 
7,10-dioxa, dithiahexadeca diene (P-17-7) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in

[[Page 57650]]

Sec.  721.63(a)(1), (2)(i), (iii), (iv), (when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1), engineering control measures (e.g., enclosure or 
confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(3), (a)(6)(v), (vi), (particulate), 
(b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(iv), 
(vi), (vii), (ix), (skin sensitization), (respiratory sensitization), 
(g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), (g)(4)(i), (g)(5). 
Alternative hazard warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g). It is a significant new use to 
manufacture, process, or use the substance involving an application 
method that generates a vapor, mist, dust, or aerosol.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 67.
    (b) Specific requirements. The provision 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 (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11200  Haloalkyl substituted carbomonocycle (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
haloalkyl substituted carbomonocycle (P-17-49) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified Sec.  
721.63(a)(1), (2)(i),(ii), (iii), (iv), (a)(3), (a)(4), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health with assigned protection factor of at least 10), 
(when determining which persons are reasonably likely to be exposed as 
required for Sec.  721.63(a)(1) and (4), engineering control measures 
(e.g., enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposure where feasible), (a)(6)(particulate) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(ix), (irritation), (sensitization), 
(liver toxicity), (mutagenicity), (g)(2)(i), (ii), (iii), (iv), (v), 
(g)(4)(i), (iii), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t). It is a significant new 
use to use the substance without the confidential engineering controls 
specified in the Order.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1).
    (v) 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 (k).
    (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.  721.11201  Amine- and hydroxy-functional acrylic polymer, 
neutralized (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine- 
and hydroxy-functional acrylic polymer, neutralized (P-17-249), is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section. The requirements of this 
section do not apply to quantities of the substance after they have 
been completely entrained in dried coating.
    (2) The significant new uses are:
    (i) Hazard communication Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(ii), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), (do not release to water without 
pre-treatment of water releases at an onsite waste water treatment 
plant with at least 96% efficiency), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the Order. It is a significant new use to manufacture or use the 
substance with methods that generate a dust, spray, mist, or aerosol.
    (iii) Disposal requirements. Requirements as specified in Sec.  
721.85(a)(1), (b)(1), and (c)(1).
    (iv) Release to water. Requirements as specified in Sec.  721.90. 
It is a significant new use to release to water without pretreatment at 
an on-site wastewater treatment plant with at least 96% efficiency.
    (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 (f) through (k) are applicable to 
manufacturers, 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.  721.11202  Amine- and hydroxy-functional acrylic polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine- 
and hydroxy-functional acrylic polymer (P-17-380), is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been 
completely entrained in dried coating.
    (2) The significant new uses are:
    (i) Hazard communication Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(ii), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), (do not release to water without 
pre-treatment of water releases at an onsite waste water treatment 
plant with at least 96% efficiency), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally

[[Page 57651]]

Harmonized System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the Order. It is a significant new use to manufacture or use the 
substance with methods that generate a dust, spray, mist, or aerosol.
    (iii) Disposal requirements. Requirements as specified in Sec.  
721.85(a)(1), (b)(1), and (c)(1).
    (iv) Release to water. Requirements as specified in Sec.  721.90. 
It is a significant new use to release to water without pretreatment at 
an on-site wastewater treatment plant with at least 96% efficiency.
    (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 (f) through (k) are applicable to 
manufacturers, 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.  721.11203  Hydroxy acrylic polymer, methanesulfonates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as hydroxy 
acrylic polymer, methanesulfonates (P-17-381), is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely 
entrained in dried coating.
    (2) The significant new uses are:
    (i) Hazard communication Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1%), (f), (g)(1)(ii), 
(g)(2)(ii), (g)(3)(ii), (g)(4)(i), (do not release to water without 
pre-treatment of water releases at an onsite waste water treatment 
plant with at least 96% efficiency), and (g)(5). Alternative hazard and 
warning statements that meet the criteria of the Globally Harmonized 
System and OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to use the 
substance without the confidential engineering controls specified in 
the Order. It is a significant new use to manufacture or use the 
substance with methods that generate a dust, spray, mist, or aerosol.
    (iii) Disposal requirements. Requirements as specified in Sec.  
721.85(a)(1), (b)(1), and (c)(1).
    (iv) Release to water. Requirements as specified in Sec.  721.90. 
It is a significant new use to release to water without pretreatment at 
an on-site wastewater treatment plant with at least 96% efficiency.
    (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 (f) through (k) are applicable to 
manufacturers, 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.  721.11204  Alkyl perfluorinated acryloyl ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
perfluorinated acryloyl ester (P-17-270) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this section do not apply to 
quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (k), and (t).
    (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, 
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)(i) of 
this section.

Sec.  721.11205  Poly(oxy-1,2-ethanediyl), .alpha.-(2-methyl-2-propen-
1-yl)-.omega.-hydroxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), .alpha.-(2-methyl-2-propen-1-yl)-.omega.-hydroxy- (P-17-
271, CAS No. 31497-33-3) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substances after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(g)(2)(ii), (iii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as a polymer intermediate. It is a significant new 
use to manufacture, process or use the substance in a manner that 
generates a vapor, mist, or aerosol, or that results in inhalation 
exposure.
    (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 (f) through (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11206  Alkylidene dicarbomonocycle, polymer with halo-
substituted heteromonocycle and disubstituted alkyl carbomonocycle 
alkenedioate alkylalkenoate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylidene dicarbomonocycle, polymer with halo-substituted 
heteromonocycle and disubstituted alkyl carbomonocycle alkenedioate 
alkylalkenoate (P-17-304) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after it has been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified

[[Page 57652]]

Sec.  721.63(a)(1), (a)(2)(i), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii),(skin 
sensitization), (g)(2)(i), (ii), (v), and (g)(5). Alternative hazard 
and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as an intermediate for thermoset plastic material. 
It is a significant new use to manufacture (includes importing) the 
substance to contain more than 0.1% residual isocyanate by weight.
    (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 (i).
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11207  Aluminum boron cobalt lithium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum boron 
cobalt lithium nickel oxide (P-17-337, CAS No. 207803-51-8) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (ii), (a)(3)(i), (ii), (a)(4), (a)(5), 
(respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 1,000), (when 
determining which persons are reasonable likely to be exposed as 
required for Sec.  721.63 (a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible), (b)(concentration set at 0.1%), and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL 0.000092 mg/m\3\ 
as an 8-hour time weighted average. Persons who wish to pursue NCELs as 
an alternative to Sec.  721.63 respirator requirements may request to 
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use 
the NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved].
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e), (concentration set at 0.1%), (f), (g)(1)(i), 
(vii), (damage to the lung, kidney, and spleen), (g)(2)(i), (iii), 
(iv), (use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\), (avoid breathing substance in the dust form), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance beyond two years. It 
is a significant new use to manufacture or process the substance at any 
facility unless all process air streams containing the substances pass 
through control technology such as a high-efficiency particulate air 
filter with a rated removal efficiency of at least 99.99%.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to dispose of the 
substances by metal reclamation unless the person reclaiming metal 
containing the substances complies with this section. It is a 
significant new use to release the substances to air unless the 
chemical transfer and air ventilation processes specified in the order 
are followed.
    (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 (j) are applicable to manufacturers, importers, and 
processors of these substances.
    (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)(iv) of 
this section.

Sec.  721.11208  Aluminum boron cobalt lithium magnesium nickel oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as aluminum boron 
cobalt lithium magnesium nickel oxide (P-17-338, CAS No. 2087499-33-8) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (ii), (a)(3)(i), (ii), (a)(4), (a)(5), 
(respirators must provide a National Institute for Occupational Safety 
and Health assigned protection factor of at least 1,000), (when 
determining which persons are reasonable likely to be exposed as 
required for Sec.  721.63 (a)(1), engineering control measures (e.g., 
enclosure or confinement of the operation, general and local 
ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible), (b)(concentration set at 0.1%), and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for this substance. The NCEL 0.000092 mg/m\3\ 
as an 8-hour time weighted average. Persons who wish to pursue NCELs as 
an alternative to Sec.  721.63 respirator requirements may request to 
do so under Sec.  721.30. Persons whose Sec.  721.30 requests to use 
the NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved].
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e), (concentration set at 0.1%), (f), (g)(1)(i), 
(vii), (damage to the lung, kidney, and spleen), (g)(2)(i), (iii), 
(iv), (use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 0.000092 
mg/m\3\), (avoid breathing substance in the dust form), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the

[[Page 57653]]

Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. It is a 
significant new use to manufacture the substance beyond two years. It 
is a significant new use to manufacture or process the substances at 
any facility unless all process air streams containing the substances 
pass through control technology such as a high-efficiency particulate 
air filter with a rated removal efficiency of at least 99.99%.
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(2), 
(b)(2), and (c)(2). It is a significant new use to dispose of the 
substances by metal reclamation unless the person reclaiming metal 
containing the substances complies with this section. It is a 
significant new use to release the substances to air unless the 
chemical transfer and air ventilation processes specified in the order 
are followed.
    (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 (j) are applicable to manufacturers, importers, and 
processors of these substances.
    (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)(iv) of 
this section.

Sec.  721.11209  Heteropolycyclic-alkanol carbomonocycle-
alkanesulfonate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
heteropolycyclic-alkanol carbomonocycle-alkanesulfonate (PMN P-17-343) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), 
(a)(6)(particulate), (b)(concentration set at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (vi), 
(ix), (eye irritation), (systemic effects), (g)(2)(i), (ii), (iii), 
(v), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k). It is a significant new use to 
manufacture, process or use the substance in a manner that results in 
inhalation exposure to a vapor, mist, dust or aerosol.
    (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 (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.  721.11210  (Substituted-dialkyl(C=1~7)silyl)alkanenitrile 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
(substituted-dialkyl(C=1~7)silyl) alkanenitrile (PMN P-17-354) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (a)(4), (a)(5)(respirators must 
provide a National Institute for Occupational Safety and Health with 
assigned protection factor of at least 50), (when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(6)(v), (vi), (particulate), (b)(concentration set 
at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(ii), 
(iv), (vi), (ix), (skin and eye irritation), (sensitization), 
(mutagenicity), (g)(2)(i), (ii), (iii), (iv), (v), (use eye 
protection), (g)(3)(i), (ii), (g)(4)(i), (iii), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (iv) Disposal. Requirements as specified in Sec.  721.85(a)(1), 
(b)(1), and (c)(1)(waste streams from use must be disposed of only by 
incineration with no less than 99.9% efficiency).
    (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 (j) 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.  721.11211  Substituted heteromonocycle, polymer with diisocyanato 
alkane and alkanediol, substituted heteromonocycle homopolymer ester 
with substituted alkylacrylate; blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted heteromonocycle, polymer with diisocyanato alkane and 
alkanediol, substituted heteromonocycle homopolymer ester with 
substituted alkylacrylate; blocked (P-17-361) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this section do not apply 
to quantities of the substance after they have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (3), (4), (5), (respirators must provide a 
National Institute for Occupational Safety and Health with assigned 
protection factor (APF) of at least 50 or an APF of at least 1,000 if 
spray applied), (when determining which persons are

[[Page 57654]]

reasonable likely to be exposed as required for Sec.  721.63 (a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposures, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 0.1%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 0.1%), (f), (g)(1)(i), 
(vii), (ix), (sensitization), (systemic effects), (g)(2)(i), (ii), 
(iii), (v), and (g)(5). Alternative hazard and warning statements that 
meet the criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture the substance containing greater than 0.25% residual 
isocyanate or an average molecular weight less than 2,280 daltons. It 
is a significant new use to use the substance other than as a dual-cure 
adhesion coating or barrier.
    (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 (i) are applicable to manufacturers, 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.  721.11212  Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, sodium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycolipids, 
sophorose-contg., candida bombicola-fermented, from C16-18 and C18-
unsatd. glycerides and D-glucose, hydrolyzed, sodium salts (P-17-401, 
CAS No. 2102535-74-8) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63 
(a)(1), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (eye irritation), (g)(2)(i), (ii), (iii), (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture, process, or use the substance for consumer use or for 
commercial uses that could introduce the substance into a consumer 
setting. It is a significant new use to manufacture, process, or use 
the substance in any manner that results in generation of a vapor, 
dust, mist or aerosol.
    (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 (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.

Sec.  721.11213  Glycolipids, sophorose-contg., candida bombicola-
fermented, from C16-18 and C18-unsatd. glycerides and D-glucose, 
hydrolyzed, potassium salts.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as glycolipids, 
sophorose-contg., Candida bombicola-fermented, from C16-18 and C18-
unsatd. glycerides and D-glucose, hydrolyzed, sodium salts (P-17-402, 
CAS No. 2102536-64-9) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (2)(i), (iii), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63 
(a)(1), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), (ii), 
(eye irritation), (g)(2)(i), (ii), (iii), (v), and (g)(5). Alternative 
hazard and warning statements that meet the criteria of the Globally 
Harmonized System and OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to 
manufacture, process, or use the substance for consumer use or for 
commercial uses that could introduce the substance into a consumer 
setting. It is a significant new use to manufacture, process, or use 
the substance in any manner that results in generation of a vapor, 
dust, mist or aerosol.
    (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 (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.

Sec.  721.11214  2-Propenoic acid, 2-methyl-, 2-(2-butoxyethoxy)ethyl 
ester, polymer with 1,3-butadiene and 2-propenenitrile.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-propenoic acid, 
2-methyl-, 2-(2-butoxyethoxy)ethyl ester, polymer with 1,3-butadiene 
and 2-propenenitrile (PMN P-17-404, CAS No. 2058302-39-7) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this section do 
not apply to quantities of the substance after they have been reacted 
(cured).
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. It is a significant new use to 
manufacture, process, or use the substance in any manner that results 
in the generation of spray, mist, aerosol, or respirable particles.
    (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

[[Page 57655]]

Sec.  721.125(a) through (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.

Sec.  721.11215  Halogenated benzoic acid ethyl ester (generic).

    (a)(1) The chemical substances identified generically in the table 
of this section are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.

              Table--Halogenated Benzoic Acid Ethyl Esters
------------------------------------------------------------------------
             PMN No.                           Chemical name
------------------------------------------------------------------------
P-17-405........................  Halogenated benzoic acid ethyl ester.
P-17-406........................  Halogenated benzoic acid ethyl ester.
P-17-407........................  Halogenated benzoic acid ethyl ester.
P-17-408........................  Halogenated benzoic acid ethyl ester.
P-17-409........................  Halogenated benzoic acid ethyl ester.
P-17-410........................  Halogenated benzoic acid ethyl ester.
P-17-411........................  Halogenated benzoic acid ethyl ester.
P-17-412........................  Halogenated benzoic acid ethyl ester.
P-17-423........................  Halogenated benzoic acid ethyl ester.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (2)(i), (iv), (3), (4), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%) and (c).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
use the substances other than for oil and gas well performance. It is a 
significant new use to manufacture or process the substances without 
the engineering controls specified in the Order. It is a significant 
new use to exceed the kilograms per day limit specified in the Order of 
the substances handled at processing and use sites.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 8.
    (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 (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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.  721.11216  Halogenated benzoic acid (generic).

    (a)(1) The chemical substances identified generically in the table 
of this section are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.

                    Table--Halogenated Benzoic Acids
------------------------------------------------------------------------
              PMN No.                           Chemical name
------------------------------------------------------------------------
P-17-414..........................  Halogenated benzoic acid.
P-17-415..........................  Halogenated benzoic acid.
P-17-416..........................  Halogenated benzoic acid.
P-17-417..........................  Halogenated benzoic acid.
P-17-418..........................  Halogenated benzoic acid.
P-17-420..........................  Halogenated benzoic acid.
P-17-421..........................  Halogenated benzoic acid.
P-17-422..........................  Halogenated benzoic acid.
P-17-441..........................  Halogenated sodium benzoate.
P-17-442..........................  Halogenated sodium benzoate.
P-17-444..........................  Halogenated sodium benzoate.
P-17-445..........................  Halogenated sodium benzoate.
P-17-446..........................  Halogenated sodium benzoate.
P-17-447..........................  Halogenated sodium benzoate.
P-17-448..........................  Halogenated sodium benzoate.
P-17-449..........................  Halogenated sodium benzoate.
P-17-450..........................  Halogenated benzoic acid.
------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), (a)(4), (when determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63(a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible), (a)(5) (respirators must provide a National Institute 
for Occupational Safety and Health with assigned protection factor of 
at least 50), (respirators are only required for P17-414 to P17-418, 
P17-420 to P17-422, and P17-450), (a)(6)(v), (vi), (particulate), 
(b)(concentration set at 1.0%) and (c).
    (A) As an alternative to the respirator requirements in paragraph 
(a)(2)(i) of this section, a manufacturer or processor may choose to 
follow the new chemical exposure limit (NCEL) provision listed in the 
TSCA section 5(e) Order for the substances. The NCEL is 0.0184 mg/m3 as 
an 8-hour time weighted average. Persons who wish to pursue NCELs as an 
alternative to Sec.  721.63 respirator requirements may request to do 
so under Sec.  721.30. Persons whose Sec.  721.30 requests to use the 
NCELs approach are approved by EPA will be required to follow NCELs 
provisions comparable to those contained in the corresponding TSCA 
section 5(e) Order.
    (B) [Reserved].
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(ii), (iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (v), (iv)(use 
respiratory protection or maintain workplace airborne concentration at 
or below an 8-hour time-weighted average of 0.0184 mg/m\3\) (This 
statement only required for P17-414 to P17-418, P17-420 to P17-422, and 
P17-450), (g)(3)(i), (ii), and (g)(5). Alternative hazard and warning 
statements that meet the criteria of the Globally Harmonized System and 
OSHA Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q) and (t). It is a significant new use to 
use the substances other than for monitoring well performance. It is a 
significant new use to manufacture or process the substances without 
the engineering controls specified in the Order. It is a significant 
new use to exceed the kilograms per day limit specified in the Order of 
the substances handled at processing and use sites. It is a significant 
new use to use P17-441 to 442 and P17-444 to P17-449 other than in a 
liquid formulation.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 460.
    (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 (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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.  721.11217  Certain halogenated sodium benzoate salts.

    (a)(1) The chemical substances listed in the table of this section 
are subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.

[[Page 57656]]

                                    Table--Halogenated Sodium Benzoate Salts
----------------------------------------------------------------------------------------------------------------
               PMN No.                     CAS No.                           Chemical name
----------------------------------------------------------------------------------------------------------------
P-17-424.............................    1708942-16-8  Benzoic acid, 2-chloro-3-methyl-, sodium salt (1:1).
P-17-425.............................    1708942-17-9  Benzoic acid, 3-chloro-2-methyl-, sodium salt (1:1).
P-17-426.............................    1708942-15-7  Benzoic acid, 3-chloro-4-methyl-, sodium salt (1:1).
P-17-427.............................     118537-88-5  Benzoic acid, 2-chloro-5-methyl-, sodium salt (1:1).
P-17-428.............................     203261-42-1  Benzoic acid, 4-chloro-2-methyl-, sodium salt (1:1).
P-17-429.............................    1708942-24-8  Benzoic acid, 3-fluoro-2-methyl-, sodium salt (1:1).
P-17-430.............................    1805805-74-6  Benzoic acid, 3- fluoro-4-methyl-, sodium salt (1:1).
P-17-431.............................    1708942-23-7  Benzoic acid, 4- fluoro-2-methyl-, sodium salt (1:1).
P-17-432.............................    1708942-19-1  Benzoic acid, 2- fluoro-4-methyl-, sodium salt (1:1).
P-17-433.............................    1708942-18-0  Benzoic acid, 2- fluoro-3-methyl-, sodium salt (1:1).
P-17-435.............................    1701446-41-4  Benzoic acid, 2- fluoro-3-(trifluoromethyl)-, sodium salt
                                                        (1:1).
P-17-436.............................    1708942-20-4  Benzoic acid, 2- fluoro-4-(trifluoromethyl)-, sodium salt
                                                        (1:1).
P-17-437.............................    1708942-21-5  Benzoic acid, 2- fluoro-6-(trifluoromethyl)-, sodium salt
                                                        (1:1).
P-17-438.............................    1535169-59-5  Benzoic acid, 3- fluoro-5-(trifluoromethyl)-, sodium salt
                                                        (1:1).
P-17-439.............................    1701446-39-0  Benzoic acid, 4- fluoro-3-(trifluoromethyl)-, sodium salt
                                                        (1:1).
P-17-440.............................    1708942-22-6  Benzoic acid, 4- fluoro-2-(trifluoromethyl)-, sodium salt
                                                        (1:1).
----------------------------------------------------------------------------------------------------------------

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (v), (g)(3)(i), (ii), 
and (g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to handle 
at a processing or use site more than 50 kilograms per day per site in 
aggregate of the PMN substances for solid formulations that generate a 
dust. It is a significant new use to use the substances other than as 
tracers in aqueous solution, in solid blends with polymers, or in a 
solid proppant bead forms to measure flow in deep oil-bearing or gas-
bearing strata.
    (iv) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) where N = 300.
    (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 (i) and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

Sec.  721.11218  Benzoic acid, 2, 3, 6-trifluoro, sodium salt (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified benzoic acid, 2, 3, 6-
trifluoro, sodium salt (1:1) (P-17-434 and P-17-443, CAS No. 1803845-
07-9) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iv), (a)(3), (when determining which persons 
are reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (e)(concentration set at 1.0%), (f), (g)(1)(i), 
(iii), (iv), (vi), (ix), (g)(2)(i), (ii), (iii), (v), and (g)(5). 
Alternative hazard and warning statements that meet the criteria of the 
Globally Harmonized System and OSHA Hazard Communication Standard may 
be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(q). It is a significant new use to 
manufacture the substance other than in a liquid formulation and 
without the confidential engineering controls specified in the Order 
for P-17-443. It is a significant new use to use the substance other 
than as a tracer in aqueous solution, a solid blend with polymer, or a 
solid proppant bead form to measure flow in deep oil-bearing or gas-
bearing strata or for the confidential use specified in the Order for 
P-17-443.
    (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 (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.  721.11219  Fatty acids, diesters with dihydroxyalkane, fatty 
acids, esters with dihydroxyalkane (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, diesters with dihydroxyalkane, fatty acids, esters with 
dihydroxyalkane (PMN P-18-3) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section. The requirements of this section do not apply to quantities of 
the substance after they have been reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (when determining which 
persons are

[[Page 57657]]

reasonably likely to be exposed as required for Sec.  721.63(a)(1), 
engineering control measures (e.g., enclosure or confinement of the 
operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible), (a)(6)(v), (vi), 
(particulate), (b)(concentration set at 1.0%) and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72 (a) through (e)(concentration set at 1.0%), (f), (g)(1), (skin 
and eye irritation and sensitization), (g)(2)(i), (ii), (iii), (v), and 
(g)(5). Alternative hazard and warning statements that meet the 
criteria of the Globally Harmonized System and OSHA Hazard 
Communication Standard may be used.
    (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 (h) 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.

Sec.  721.11220  Substituted carbomonocycle, polymer with halo 
substituted heteromonocycle and polyoxyalkylene polymer with 
alkylenebis (isocyanatocarbomonocycle) bis 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed, (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted carbomonocycle, polymer with halo substituted 
heteromonocycle and polyoxyalkylene polymer with 
alkylenebis(isocyanatocarbomonocycle) his 
(carbomonocycledicarboxylate), reaction products with alkylamines, 
hydrolyzed, (P-18-22) is subject to reporting under this section for 
the significant new uses described in paragraph (a)(2) of this section. 
The requirements of this section do not apply to quantities of the 
substance after they have been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (iii), (iv), (a)(3), (a)(4), 
(a)(5)(respirators must provide a National Institute for Occupational 
Safety and Health with assigned protection factor of at least 50), 
(when determining which persons are reasonable likely to be exposed as 
required for Sec.  721.63 (a)(1) and (a)(4), engineering control 
measures (e.g., enclosure or confinement of the operation, general and 
local ventilation) or administrative control measures (e.g., workplace 
policies and procedures) shall be considered and implemented to prevent 
exposures, where feasible), (a)(6)(particulate), and (c).
    (ii) Hazard communication. Requirements as specified in Sec.  
721.72(a) through (d), (f), (g)(1)(ii), (irritation to skin, eyes, 
lungs, and mucous membranes), (g)(2)(i), (ii), (iii), (iv), (v), (avoid 
eye contact), and (g)(5). Alternative hazard and warning statements 
that meet the criteria of the Globally Harmonized System and OSHA 
Hazard Communication Standard may be used.
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f). It is a significant new use to use the 
substance other than as primer coating used for corrosion protection. 
It is a significant new use to import the substance with an average 
molecular weight greater less than 1026 daltons, and with low weight 
fractions greater than 15.3% less than 500 daltons and 25% less than 
1000 daltons.
    (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 (i) are applicable to manufacturers, 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. 2018-24380 Filed 11-14-18; 8:45 am]
 BILLING CODE 6560-50-P