Significant New Use Rules on Certain Chemical Substances, 61117-61155 [2012-23993]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Pages 61117-61155]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23993]



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Vol. 77

Friday,

No. 194

October 5, 2012

Part IV





Environmental Protection Agency





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40 CFR Part 9 and 721





Significant New Use Rules on Certain Chemical Substances; Final Rule

Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules 
and Regulations

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0277; FRL-9364-5]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 78 chemical substances 
which were the subject of premanufacture notices (PMNs). Seven of these 
chemical substances are subject to TSCA section 5(e) consent orders 
issued by EPA. This action requires persons who intend to manufacture, 
import, or process any of these 78 chemical substances for an activity 
that is designated as a significant new use by this rule to notify EPA 
at least 90 days before commencing that activity. The required 
notification will provide EPA with the opportunity to evaluate the 
intended use and, if necessary, to prohibit or limit that activity 
before it occurs.

DATES: This rule is effective on December 4, 2012. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 19, 2012.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before November 5, 2012 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION).
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2012-0277, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments.
     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: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: 
Docket ID Number EPA-HQ-OPPT-2012-0277. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2012-0277. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at https://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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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 submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the Agency taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture, import, or processing of a chemical 
substance for any activity designated by these SNURs as a significant 
new use. Receipt of such notices allows 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 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) (April 24, 1990 SNUR). 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, import, or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same SNUN requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA sections 5(b) 
and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 
5(h)(2), 5(h)(3), and 5(h)(5), and the regulations at 40 CFR part 720. 
Once EPA receives a SNUN, EPA may take regulatory action under TSCA 
section 5(e), 5(f), 6, or 7 to control the activities for which it has 
received the SNUN. If EPA does not take action, EPA is required under 
TSCA section 5(g) to explain in the Federal Register its reasons for 
not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 78 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 84 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) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA 
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes 7 PMN substances (P-04-80, P-06-149, P-06-153, 
P-07-

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327, P-09-48, P-09-636, and P-10-367) that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA 
determined that activities associated with the PMN substances may 
present unreasonable risk to human health or the environment. Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNURs'' on these PMN substances are promulgated pursuant to 
Sec.  721.160, and are based on and consistent with the provisions in 
the underlying consent orders. The 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    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) consent 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) 
consent 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. 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 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) consent order for the same 
chemical substance.
    This rule also includes SNURs on 71 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). However, EPA does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
section 5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-section 5(e) SNURs issued under Sec.  721.170 satisfies the 
two requirements stipulated in Sec.  721.170(c)(2), i.e., these 
significant new use activities, ``(i) are different from those 
described in the premanufacture notice for the substance, including any 
amendments, deletions, and additions of activities to the 
premanufacture notice, and (ii) may be accompanied by changes in 
exposure or release levels that are significant in relation to the 
health or environmental concerns identified'' for the PMN substance.
PMN Number P-00-535
    Chemical name: 1-Octadecanol, manuf. of, distn. lights, 
fractionation heavies, distn. lights.
    CAS number: 243640-46-2.
    Basis for action: The PMN states that the substance will be used as 
a feedstock for esterification. Based on ecological structure activity 
relationship (EcoSAR) analysis of test data on analogous neutral 
organic chemicals, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 part per billion (ppb) of the PMN 
substance in surface waters for greater than 20 days per year. This 20-
day criterion is derived from partial life cycle tests (daphnid chronic 
and fish early-life stage tests) that typically range from 21 to 28 
days in duration. EPA predicts toxicity to aquatic organisms may occur 
if releases of the PMN substance to surface water exceed releases from 
the use described in the PMN. For the use described in the PMN, 
environmental releases did not exceed 1 ppb for more than 20 days per 
year. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance other than as a feedstock for esterification may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (Office of Pollution Prevention and 
Toxics (OPPTS) Test Guideline 850.1400); a daphnid chronic toxicity 
test (OPPTS Test Guideline 850.1300); and an algal toxicity test 
(Office for Chemical Safety and Pollution Prevention (OCSPP) Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10426.
PMN Number P-01-579
    Chemical name: Acrylate ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer. Based on 
EcoSAR analysis of test data on analogous acrylates, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
50 ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the PMN substance are not expected to result in surface 
water concentrations that exceed 50 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 50 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help to characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10537
PMN Number P-02-161
    Chemical name: Phosphonium, tetrakis (hydroxymethyl)-, chloride 
(1:1), reaction products with 1-tetradecanamine and urea.
    CAS number: 359406-89-6.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a flame retardant. Based 
on test data on the PMN substance and EcoSAR analysis of test data on 
analogous cationic surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 2 ppb of the PMN 
substance in surface waters. As described in the PMN, the substance is 
not released to surface waters. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable

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risk. EPA has determined, however, that any use of the substance 
resulting in surface water concentrations exceeding 2 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170 (b)(4)(i) 
and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
and an aquatic invertebrate acute toxicity test, freshwater daphnids 
(OPPTS Test Guideline 850.1010) would help characterize the 
environmental and fate effects of the PMN substance.
    CFR citation: 40 CFR 721.10538.
PMN Number P-02-653
    Chemical name: Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a resin for electronic laminates, adhesives, encapsulants, and 
composites. Based on EcoSAR analysis of test data on analogous neutral 
organic chemicals, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730); a 
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10539.
PMN Number P-02-984
    Chemical name: 1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.
    CAS number: 404362-22-7.
    Basis for action: The PMN states that the substance will be used as 
an epoxy curing agent. Based on EcoSAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 5 ppb of the PMN substance in 
surface waters. As described in the PMN, the substance is not released 
to surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 5 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10540.
PMN Number P-03-481
    Chemical name: 5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, 
octahydro-1,3,4,7,8,10-hexanitro-.
    CAS number: 135285-90-4.
    Basis for action: The PMN substance will be used as an explosive 
and propellant. Based on structure activity relationship (SAR) analysis 
of test data on analogous octahydro-1,3,5,7-tetranitro-1,3,5,7-
tetrazocine (also called HMX or octogen); CAS No. 2691-41-0, as well as 
test data for hexahydro-1,3,5-trinitro-1,3,5-triazine (also called RDX, 
cyclonite, hexogen, or cyclotrimethylenetrinitramine); CAS No. 121-82-
4, EPA identified concerns for neurotoxicity, including severe 
convulsions or seizures, systemic effects, reproductive and 
developmental effects, immunotoxicity and oncogenicity from exposure to 
the PMN substance. In addition, based on EcoSAR analysis of test data 
on analogous polynitro organic analogues, EPA predicts toxicity to 
aquatic organisms from the degradation product of the PMN substance at 
surface water concentrations that exceed 50 ppb of the degradation 
product. For the use described in the PMN, dermal and inhalation 
exposures are not expected, and releases to surface waters are not 
expected to result in surface water concentrations exceeding 50 ppb for 
the PMN degradation product. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that use of the 
substance without respiratory protection, impervious gloves, or release 
to surface waters without chemical destruction or conversion may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity study with reproductive/developmental 
toxicity screening test, including neurotoxicity assessment and 
functional observations (OPPTS Test Guideline 870.3650); a combined 
chronic toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); 
a hydroysis as a function of pH and temperature test (OPPTS Test 
Guideline 835.2130); and a ready biodegradability test (OPPTS Test 
Guideline 835.3110) would help to characterize the human health and 
environmental fate of the PMN substance.
    CFR citation: 40 CFR 721.10541.
PMN Number P-03-624
    Chemical name: Dodecanedioic acid, 1,12-dimethyl ester.
    CAS number: 1731-79-9.
    Basis for action: The PMN states that the substance will be used as 
a chemical intermediate. Based on EcoSAR analysis of test data on 
analogous esters, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 30 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the PMN substance are not 
expected to result in surface water concentrations that exceed 30 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, and use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 30 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help

[[Page 61122]]

characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10542.
PMN Number P-04-79
    Chemical name: Oxetane, 3-methyl-3-[(2,2,3,3,3-
pentafluoropropoxy)methyl]-.
    CAS number: 449177-94-0.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer in the 
production of reactive polymers for surface coatings and other polymer 
intermediates. Based on SAR analysis of test data on analogous 
oxetanes, EPA identified concerns for male reproductive toxicity, liver 
toxicity, and thyroid effects from exposure to the PMN substance. As 
described in the PMN, significant inhalation exposures are not expected 
and dermal exposures are not expected due to the use of protective 
gloves. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance without dermal protection where there is a potential for 
dermal exposures may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose test with a reproductive/developmental toxicity 
screening (Organisation for Economic Co-operation and Development 
(OECD) Test Guideline 422) via gavage in rats would help characterize 
the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10543.
PMN Number P-04-80
    Chemical name: Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-
nonafluorohexyl)oxy]methyl]-.
    CAS number: 475678-78-5.
    Effective date of TSCA section 5(e) consent order: December 28, 
2004.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
substance will be used as a monomer in the production of reactive 
polymers for surface coating materials and other polymer intermediates. 
EPA has identified health and environmental concerns because the 
substance may be a persistent, bio-accumulative, and toxic (PBT) 
chemical, based on physical/chemical properties of the PMN substance, 
as described in the New Chemical Program's PBT category (64 FR 60194; 
November 4, 1999) (FRL-6097-7). Also, based on SAR analysis of test 
data on analogous oxetanes, EPA identified concerns for male 
reproductive toxicity and systemic effects from exposures to the PMN 
substance. Further, based on EcoSAR analysis of analogous oxetanes, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 5 ppb of the PMN substance in surface waters. The consent order 
was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 
5(e)(1)(A)(ii)(II), based on a finding that this substance may present 
an unreasonable risk of injury to human health and the environment, the 
substance may be produced in substantial quantities and may reasonably 
be anticipated to enter the environment in substantial quantities, and 
there may be significant (or substantial) human exposure to the 
substance and its potential degradation products. To protect against 
these risks, the consent order requires:
    1. Use of personal protective equipment including dermal protection 
(where there is a potential for dermal exposure).
    2. Establishment and use of a hazard communication program.
    3. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity test with a reproductive/developmental 
toxicity screening test (OPPTS Test Guideline 870.3650 or OECD Test 
Guideline 422) in rats by gavage would help characterize possible human 
health effects of the PMN substance. The PMN submitter has agreed not 
to exceed the confidential production limit specified in the consent 
order without performing this test. In addition, EPA has determined the 
results of a log Kow test (OECD Test Guideline 117), and (depending 
upon the results of the log Kow test) a fish BCF test (OPPTS Test 
Guideline 850.1730); a fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity 
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal 
toxicity test (OCSPP Test Guideline 850.4500), would help characterize 
the persistence, bioaccumulation, and environmental effects of the PMN 
substance. The consent order does not require submission of this 
additional recommended testing at any specified time or production 
volume. However, the consent order's restrictions on manufacture, 
import, processing, distribution in commerce, use, and disposal of the 
PMN substance will remain in effect until the Order is modified or 
revoked by EPA based on submission of that or other relevant 
information.
    CFR citation: 40 CFR 721.10544.
PMN Number P-04-313
    Chemical name: Aminotriazine modified cresol novolec resin 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a glass epoxy laminate. 
Based on EcoSAR analysis of test data on analogous phenols, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 10 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the PMN substance are not expected to result in 
surface water concentrations that exceed 10 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance presents an unreasonable risk. EPA has determined, however, 
that any use of the substance resulting in surface water concentrations 
exceeding 10 ppb may cause significant adverse environmental effects. 
Based on this information the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
BCF test (OPPTS Test Guideline 850.1730), and either an aerobic and 
anaerobic transformation in aquatic sediment systems test (OECD Test 
Guideline 308) or a shake flask die-away test (OPPTS Test Guideline 
835.3170) would help to characterize the environmental effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10545.
PMN Number P-04-340
    Chemical name: Pentenylated polyethylene glycol sulfate salt 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymerization 
additive. Based on EcoSAR analysis of test data on analogous anionic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the substance are not 
expected to result in surface water concentrations that exceed 1 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 1 ppb may cause significant 
adverse

[[Page 61123]]

environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help to characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10546.
PMN Number P-04-587
    Chemical name: Dialkyl dimethyl ammonium methylcarbonate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a chemical intermediate. Based on EcoSAR analysis of test data on 
analogous cationic surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 5 ppb of the PMN 
substance in surface waters for greater than 20 days per year. This 20-
day criterion is derived from partial life cycle tests (daphnid chronic 
and fish early-life stage tests) that typically range from 21 to 28 
days in duration. EPA predicts toxicity to aquatic organisms may occur 
if releases of the PMN substance to surface water exceed releases from 
the use described in the PMN. For the chemical intermediate use 
described in the PMN, environmental releases did not exceed 5 ppb for 
more than 20 days per year. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance other than as a chemical intermediate may cause significant 
adverse environmental effects. Based on this information the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10547.
PMN Number P-04-624
    Chemical name: Mixed alkyl phosphate esters alkoxylated (generic).
    CAS number: Not available.
    Basis for action: The PMN substance will be used as a component in 
a lubricant blend. Based on EcoSAR analysis of test data on analogous 
nonionic surfactants, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 40 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 40 
ppb. Therefore, EPA has not determined that manufacturing, processing, 
and use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance resulting in surface 
water concentrations exceeding 40 ppb may cause significant adverse 
environmental effects. Based on this information the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help to characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10548.
PMN Number P-04-635
    Chemical name: Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-
trifluoroethoxy)-.
    CAS number: 406-78-0.
    Basis for action: The PMN states that the substance will be used 
for cleaning electronic components, precision cleaning, dewatering of 
electronic components and other parts following aqueous cleaning, and 
as a carrier/lubricant coating for hard disk drives and other precision 
parts. Based on test data on the PMN substance, EPA identified concerns 
for neurotoxicity. For the industrial use described in the PMN, the 
substance is imported and no significant worker exposures are expected. 
Therefore, EPA has not determined that the proposed processing or use 
of the substance presents an unreasonable risk. EPA has determined, 
however, that domestic manufacture, use in non-industrial products, or 
use other than as described in the PMN may cause serious chronic health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that inhalation monitoring 
data, collected according to the EPA draft Inhalation Monitoring Data 
Collection Guidelines (located in the docket under docket ID number 
EPA-HQ-OPPT-2012-0277) would help characterize the human health effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10549.
PMN Number P-05-324
    Chemical name: Rare earth salt of a carboxylic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a paint component. Based 
on SAR analysis of test data on analogous lanthanides, EPA identified 
concerns for developmental toxicity, kidney toxicity, and blood 
toxicity (specifically, anticoagulant activity). In addition, based on 
EcoSAR analysis of test data on analogous organic and inorganic salts, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 5 ppb of the PMN substance in surface waters. For the use 
described in the PMN, significant worker and general population 
exposures are not expected, and releases of the substance are not 
expected to result in surface water concentrations that exceed 5 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance presents an unreasonable risk. EPA 
has determined, however, that any use of the substance other than as 
described in the PMN, or any use resulting in surface water 
concentrations exceeding 5 ppb may cause serious health effects and 
significant adverse environmental effects. Based on this information 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of an 
acute oral toxicity test (OPPTS Test Guideline 870.1100); a bacterial 
reverse mutation test (OPPTS Test Guideline 870.5100); a mammalian 
erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) via the 
intraperitoneal route; a repeated dose 28-day oral toxicity test in 
rodents (OPPTS Test Guideline 870.3050), including a neurotoxicity 
functional observational battery, as described in the neurotoxicity 
screening battery (OPPTS Test Guideline 870.6200); a prenatal 
developmental toxicity test (OPPTS Test Guideline 870.3700) in one 
species, via the oral route; either a porous pot test (OPPTS Test 
Guideline 835.3220) or an aerobic sewage treatment simulation test 
(OECD Test Guideline 303A); a fish acute toxicity test, freshwater and 
marine (OPPTS Test Guideline 850.1075); an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and 
an algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the human health and environmental effects of the PMN 
substance.

[[Page 61124]]

    CFR citation: 40 CFR 721.10550.
PMN Number P-05-613
    Chemical name: Bisphenol S mono ether (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a color developer. Based 
on SAR analysis of test data on analogous epoxides, EPA identified 
concerns for respiratory sensitization, mutagenicity, oncogenicity, 
developmental toxicity, male reproductive toxicity, liver toxicity, and 
kidney toxicity. In addition, based on test data on the PMN substance 
and EcoSAR analysis of test data on analogous phenols, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface water. For the use described in the 
PMN, occupational exposures during manufacture are not expected as the 
PMN substance is imported. Occupational exposures during processing and 
use are not expected to be significant due to expected use of 
appropriate personal protective equipment, and the substance is not 
released to surface waters during processing or use. Therefore, EPA has 
not determined that the proposed processing or use of the substance 
presents an unreasonable risk. EPA has determined, however, that 
domestic manufacture, any use of the substance other than as described 
in the PMN, or any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170 (b)(1)(i)(C), (b)(3)(ii), 
(b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity with the reproduction/development 
toxicity screening test (OPPTS Test Guideline 870.3650); a 
carcinogenicity test (OPPTS Test Guideline 870.4200); a fish early-life 
stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300) would help 
characterize the human health and environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10551.
PMN Number P-05-774
    Chemical name: Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-
chlorophenyl)methyl]-.
    CAS number: 134818-68-1.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
Based on test data on the PMN substance, EPA identified concerns for 
dermal sensitization. In addition, based on SAR analysis of test data 
on analogous epoxides and chlorobenzenes, EPA identified concerns for 
carcinogenicity, mutagenicity, systemic toxicity, neurotoxicity, and 
reproductive toxicity from worker exposures. Further, based on test 
data on the PMN substance and EcoSAR analysis of test data on analogous 
monoepoxides, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 2 ppb of the PMN substance in surface 
waters. For the site-limited intermediate use described in the PMN, 
significant worker dermal exposure is unlikely due to the use of 
impervious personal protective equipment and releases of the substance 
are not expected to result in surface water concentrations that exceed 
2 ppb. Therefore, EPA has not determined that manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the substance without workers 
wearing impervious gloves, where there is a potential for dermal 
exposures; use of the substance other than as a site-limited chemical 
intermediate, or any use of the substance resulting in surface water 
concentrations exceeding 2 ppb may cause serious health effects and 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
porous pot test (OPPTS Test Guideline 835.3220); a mammalian 
erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) by the 
intraperitoneal route; a combined repeated dose toxicity test (OPPTS 
Test Guideline 870.3650) with the reproduction/development toxicity 
screening test and neurotoxicity endpoints; a carcinogenicity test 
(OPPTS Test Guideline 870.4200); a fish early-life stage toxicity test 
(OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test (OPPTS 
Test Guideline 850.1300); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the human health and 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10552.
PMN Number P-06-149
    Chemical name: Potassium titanium oxide.
    CAS number: 12673-69-7.
    Effective date of TSCA section 5(e) consent order: March 18, 2008.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance is as a physical 
characteristics modifier for industrial use in certain solid composite 
articles. Based on test data on the PMN substance and SAR analysis of 
test data on analogous respirable, poorly soluble particulates 
(subcategory titanium dioxide), EPA identified concerns for lung 
toxicity and fibrosis in workers exposed to the PMN substance by the 
inhalation route. The Order was issued under sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) of TSCA based on a finding that the substance may 
present an unreasonable risk of injury to human health. To protect 
against this risk, the consent order requires:
    1. Use of personal protective equipment including a National 
Institute for Occupational Safety and Health (NIOSH)-certified 
respirator with an assigned protection factor (APF) of at least 10, or 
compliance with a NCEL of 1.5 mg/m\3\ as a time weighted average (when 
there is a potential for inhalation exposures).
    2. Establishment and use of a hazard communication program.
    3. No manufacture of the PMN substance with a particle size less 
than 100 nanometers.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA determined that the results of the 
following study would help characterize the human health effects of the 
PMN substance: A 90-day inhalation toxicity test with special attention 
to histopathology (inflammation and cell proliferation) of the lung 
tissues and to various parameters of the broncoalveolar lavage fluid 
(BALF), e.g., marker enzyme activities, total protein content, total 
cell count, cell differential, and cell viability (OPPTS Test Guideline 
870.3465).
    CFR citation: 40 CFR 721.10553.
PMN Number P-06-153
    Chemical name: Iso-tridecanol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: October 13, 
2006.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
substance will be used as a reactant. Based on test data on the PMN

[[Page 61125]]

substance, and EcoSAR analysis of test data on analogous neutral 
organic compounds, EPA predicts toxicity to aquatic organisms at 
concentrations that exceed 8 ppb of the PMN substance in surface 
waters. Further, aquatic toxicity, persistence, and bioaccumulation 
potential vary depending on the isoindex (i.e., the average number of 
branches per alkyl unit) of the PMN substance. EPA has determined that 
as the isoindex increases, persistence and bioaccumulation values 
increase. At the isoindex value of 2.32 for the intended PMN substance, 
the substance is not considered a PBT chemical and aquatic toxicity 
risk is mitigated by the decrease in persistence. However, as the 
isoindex increases above 3, EPA estimates that the PMN substance will 
persist in the environment more than two months and EPA estimates a 
bioaccumulation factor of greater than or equal to 1000. If the 
isoindex is less than three, the PMN is not expected to persist. The 
consent order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I), based on a finding that this substance may present 
an unreasonable risk of injury to the environment. To protect against 
these risks, the consent order requires manufacture of the PMN 
substance according to the chemical composition section of the consent 
order, with no greater than an average of three branches per alkyl unit 
and routine analysis of the PMN substance to verify compliance with the 
average number of alkyl units restriction. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); and a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300) would help 
characterize the environmental effects of the PMN substance. The 
consent order does not require the submission of this testing at any 
specified time or production volume. However, the consent order's 
restrictions on manufacture, import, processing, distribution in 
commerce, use, and disposal of the PMN substances will remain in effect 
until the consent order is modified or revoked by EPA based on 
submission of that or other relevant information.
    CFR citation: 40 CFR 721.10554.
PMN Number P-06-370
    Chemical name: Benzoic acid nonyl ester, branched and linear.
    CAS number: 670241-72-2.
    Basis for action: The PMN states that the substance will be used as 
a softener for polyvinyl chloride. Based on test data on the PMN 
substance, EPA identified concerns for developmental toxicity from 
exposure to the PMN substance. In addition, based on test data on the 
PMN substance and EcoSAR analysis of test data on analogous esters, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 6 ppb of the PMN substance in surface waters. As described in 
the PMN, dermal exposures are not expected due to the use of impervious 
gloves and no domestic manufacture, and releases of the PMN substance 
are not expected to result in surface water concentrations that exceed 
6 ppb. Therefore, EPA has not determined that the proposed processing 
or use of the substance presents an unreasonable risk. EPA has 
determined, however, that any use of the substance without impervious 
gloves, where there is a potential for dermal exposures; any domestic 
manufacture; or any use of the substance resulting in surface water 
concentrations exceeding 6 ppb may cause serious health effects and 
significant adverse environmental effects. Based on this information 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(3)(i), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day subchronic dermal toxicity test in rats (OPPTS Test Guideline 
870.3250) and a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300) would help characterize the human health and environmental 
effects of the PMN substance. EPA also recommends that the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10555.
PMN Numbers P-06-450, P-06-451, and P-06-452
    Chemical names: (P-06-450) Poly(oxy-1,2-ethanediyl), .alpha.- (2-
methyl-2-propen-1-yl) -.omega.-hydroxy-,C12-15-alkyl ethers; 
(P-06-451) Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) 
-.omega.-hydroxy-,C10-16-alkyl ethers; and (P-06-452) 
Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) -.omega.-
hydroxy-,C12-16-alkyl ethers.
    CAS numbers: (P-06-450) 675869-02-0; (P-06-451) 620610-66-4; and 
(P-06-452) 675869-05-3.
    Basis for action: The consolidated PMN states that the substances 
will be used as wetting agents for low foam spray metal cleaning. Based 
on EcoSAR analysis of test data on analogous neutral organic chemicals, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 10 ppb of the PMN substances in surface waters. At the 
combined production volume stated in the notice, releases of the PMN 
substances are not expected to result in surface water concentrations 
that exceed 10 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any increase in 
the combined annual manufacture and import volume of 45,000 kilograms 
(kgs) of the substances could result in exposures which may cause 
significant adverse environmental effects. Based on this information, 
the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075) on any of the three PMN substances would help characterize 
the environmental effects of the PMN substances.
    CFR citations: 40 CFR 721.10556 (P-06-450); 40 CFR 721.10557 (P-06-
451); and 40 CFR 721.10558 (P-06-452).
PMN Number P-06-793
    Chemical name: Morpholine, 4-C6-12 acyl derivs.
    CAS number: 887947-29-7.
    Basis for action: The PMN states that the substance will be used as 
a pesticide dispersant/solvent. Based on test data on the PMN 
substance, EPA identified concerns for systemic effects from dermal 
exposures. As described in the PMN, worker dermal exposures are not 
expected due to the use of impervious skin protection and hazard 
communication warnings for systemic effects. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance without impervious dermal 
protection, where there is a potential for dermal exposures, or any use 
of the substance without hazard communication warnings for systemic 
effects may cause serious health effects. Based on this information, 
the PMN meets the concern criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of 90-day 
subchronic dermal toxicity test (OPPTS Test Guideline 870.3250) would 
help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10559.

[[Page 61126]]

PMN Numbers P-07-143 and P-07-144
    Chemical names: Alkanoldioic dialkyl esters (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as lubricant additives. 
Based on EcoSAR analysis of test data on analogous esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 3 
ppb of the PMN substances in surface waters for greater than 20 days 
per year. This 20-day criterion is derived from partial life cycle 
tests (daphnid chronic and fish early-life stage tests) that typically 
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the PMN substances to surface water 
exceed releases from the use described in the PMNs. For the use 
described in the PMNs, environmental releases did not exceed 3 ppb for 
more than 20 days per year. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substances presents 
an unreasonable risk. EPA has determined, however, that any use of the 
substances other than as described in the PMNs may cause significant 
adverse environmental effects. Based on this information the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) would 
help characterize the environmental effects of the PMN substances. EPA 
also recommends that the special considerations for conducting aquatic 
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10560.
PMN Number P-07-327
    Chemical name: Substituted phenol (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: September 17, 
2008.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an 
antioxidant. Based on EcoSAR analysis of test data on analogous 
phenols, EPA predicts toxicity to aquatic organisms at concentrations 
that exceed 1 ppb of the PMN substance in surface waters. The consent 
order was issued under TSCA sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), 
and 5(e)(1)(A)(ii)(II), based on a finding that the substance may 
present an unreasonable risk of injury to the environment, may be 
produced in substantial quantities, and may reasonably be anticipated 
to enter the environment in substantial quantities. To protect against 
these risks, the consent order requires:
    1. Establishment and use of a hazard communication program.
    2. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
human health toxicity testing specified in the consent order would help 
characterize the human health effects of the substance. The PMN 
submitter has agreed not to exceed the confidential production volume 
limit without performing an in vitro mouse lymphoma assay (mammalian 
cell mutation test) (OPPTS Test Guideline 870.5300) and a repeated dose 
28-day oral toxicity test (OPPTS Test Guideline 870.3050) to include a 
neurotoxicity battery (OPPTS Test Guideline 870.6200).
    In addition, EPA has determined that the results of a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); a daphnid 
chronic toxicity test (OPPTS Test Guideline 850.1300); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the environmental effects of the PMN substance. The consent order does 
not require submission of this aquatic toxicity testing by any 
specified time or production volume. However, the consent order's 
restrictions on manufacture, import, processing, distribution in 
commerce, use and disposal of the PMN will remain in effect until the 
consent order is modified or revoked by EPA based on submission of that 
or other relevant information.
    CFR citation: 40 CFR 721.10561.
PMN Number P-07-375
    Chemical name: Aluminum trihydrate and silane homopolymer 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as a flame retardant. Based on test data on an analogous insoluble 
high molecular weight polymer, EPA identified concerns for lung 
toxicity if the PMN substance is inhaled. At an annual production 
volume of 100,000 kgs, worker exposure is limited and consumer exposure 
is not expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any increase of 
the annual 100,000 kg production volume may result in increased 
exposure to the PMN substance which may cause significant adverse human 
health effects. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10562.
PMN Number P-07-496
    Chemical name: 2-Oxiranemethanamine, N-[3-(2-
oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-.
    CAS number: 71604-74-5.
    Basis for action: The PMN substance will be used as a preparation 
of pre-impregnated cloth/fiber tapes for aerospace composite articles. 
Based on SAR analysis of test data on analogous epoxides, EPA 
identified concerns for oncogenicity, mutagenicity, developmental 
toxicity, reproductive toxicity, and liver toxicity from exposure to 
the PMN substance. As described in the PMN, worker dermal exposure to 
the PMN substance will be minimal due to the use of impervious gloves, 
and no significant inhalation exposure is expected. Therefore, EPA has 
not determined that the proposed manufacturing, processing, or use of 
the substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance without the use of impervious 
gloves, where there is potential for dermal exposure, or any use of the 
substance other than as a preparation of pre-impregnated cloth/fiber 
tapes for aerospace composite articles may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day subchronic dermal toxicity test in rats (OPPTS Test Guideline 
870.3250) and a dermal carcinogenicity test (OPPTS Test Guideline 
870.4200) would help characterize the human health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10563.
PMN Number P-08-39
    Chemical name: Mixed amino diaryl sulfone isomers (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a hardening agent. Based 
on SAR analysis of test data on analogous dianilines, EPA identified

[[Page 61127]]

concerns for immunotoxicity, oncogenicity, blood effects, liver 
effects, and hypersensitivity from exposures to the PMN substance. In 
addition, based on EcoSAR analysis of analogous dianilines, EPA 
predicts toxicity to aquatic organisms at concentrations that exceed 8 
ppb of the PMN substance in surface waters. For the non-consumer use 
described in the PMN, significant worker exposures are not expected as 
the PMN is used in liquid form, and releases of the substance to 
surface waters are not expected. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance 
presents an unreasonable risk. EPA has determined, however, that any 
use of the substance in consumer products, any use of the substance in 
the form of a powder, or any use of the substance resulting in surface 
water concentrations exceeding 8 ppb may cause serious health effects 
and significant adverse environmental effects. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a rat 
acute oral retinopathy screening test; a pigmented rat 90-day 
subchronic toxicity test (OPPTS Test Guidelines 870.3100 or 870.3465) 
by either the oral or inhalation route, including histopathological 
examination of the eyes (by both light and electron microscopy) and 
reproductive organs; a fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075); an aquatic invertebrate acute toxicity 
test, freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the human health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10564.
PMN Number P-08-263
    Chemical name: Ethanol, 2,2'-[[3-[(2-
hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) 
derivs.
    CAS number: 90367-25-2.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material to 
manufacture a surfactant blend. Based on EcoSAR analysis of test data 
on analogous aliphatic amines, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb of the PMN 
substance in surface waters. As described in the PMN, releases of the 
PMN substance are not expected to result in surface water 
concentrations that exceed 1 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in surface water concentrations 
exceeding 1 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
simulation test--aerobic sewage treatment: activated sludge units 
(OPPTS Test Guideline 835.3240); a fish acute toxicity test, freshwater 
and marine (OPPTS Test Guideline 850.1075); a fish acute toxicity 
mitigated by humic acid (OPPTS Test Guideline 850.1085); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 
850.4500) would help characterize the environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10565.
PMN Number P-08-292
    Chemical name: 1-Propanamine, N- (1-methylethyl) -,3- 
(C12-15-alkyloxy) derivs.
    CAS number: 944835-56-7.
    Basis for action: The PMN states that the substance will be used as 
a lubricant additive intermediate. Based on EcoSAR analysis of test 
data on analogous aliphatic amines, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb of the 
substance in surface waters. As described in the PMN, the substance is 
not released to surface waters. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance 
presents an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in surface water concentrations 
exceeding 1 ppb may cause significant adverse environmental effects. 
Based on this information the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10566.
PMN Number P-08-300
    Chemical name: Amidoamine salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a laundry product 
additive. Based on EcoSAR analysis of test data on analogous aliphatic 
amines, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the substance in surface waters. As 
described in the PMN, releases of the substance are not expected to 
result in surface water concentrations that exceed 1 ppb. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance presents an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10567.
PMN Number P-08-464
    Chemical name: Diethanolamine salt of polymeric acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a pigment dispersant in latex paints. Based on EcoSAR analysis of test 
data on analogous inorganic phosphates, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 4 ppb of the 
substance in surface waters. As described in the PMN, releases of the 
substance are not expected to result in surface water concentrations 
that exceed 4 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 4 ppb may 
cause significant adverse environmental effects. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).

[[Page 61128]]

    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10568.
PMN Number P-08-471
    Chemical name: Tricyclic quaternary amine salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
Based on EcoSAR analysis of test data on analogous cationic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 100 ppb of the substance in surface waters. 
As described in the PMN, the substance is not released to surface 
waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 100 ppb 
may cause significant adverse environmental effects. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10569.
PMN Number P-08-537
    Chemical name: Cyclic amine reaction product with acetophenone and 
formaldehyde acid salt (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an acid inhibitor. Based 
on test data on the PMN substance and EcoSAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 8 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the PMN substance 
are not expected to result in surface water concentrations that exceed 
8 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance presents an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 8 ppb may 
cause significant adverse environmental effects. Based on this 
information the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10570.
PMN Number P-08-611
    Chemical name: 1,3-Benzenediol, polymer with 1,1'-
methylenebis[isocyanatobenzene].
    CAS number: 1008753-84-1.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a rubber additive. Based 
on SAR analysis of test data on analogous diisocyanates, EPA identified 
concerns for dermal and respiratory sensitization and for pulmonary 
toxicity to workers exposed to free isocyanates. Also, based on EcoSAR 
analysis of test data on analogous esters and phenols, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. For the use scenarios 
described in the PMN, which were supported by product composition tests 
and simulated use condition tests, significant worker exposure is not 
expected, and the substance is not released to surface waters. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the substance other than as 
described in the PMN (manufacture with all isocyanate groups reacted 
within the polymer), or any use of the substance resulting in surface 
water concentrations exceeding 1 ppb could result in exposures which 
may cause serious health effects or significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
dermal sensitization test (OPPTS Test Guideline 870.2600); a 90-day 
subchronic inhalation toxicity test (OPPTS Test Guideline 870.3465); a 
fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the human 
health and environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10571.
PMN Number P-08-680
    Chemical name: Benzamide, N-[[4- 
[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-.
    CAS number: 221667-31-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adjuvant for 
agricultural products. Based on test data on the PMN substance, EPA 
identified concerns for urinary tract toxicity from exposure to the PMN 
substance. As described in the PMN, worker dermal and inhalation 
exposures will be minimal due to the use of impervious gloves, a NIOSH-
certified respirator with an APF of at least 10, and establishment of a 
hazard communication program. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substance without impervious gloves, where there is a potential 
for dermal exposures; any use of the substance without a NIOSH-
certified respirator with an APF of at least 10, where there is a 
potential for inhalation exposures; or without establishing the hazard 
communication program may result in serious health effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(i).
    Recommended testing: EPA has determined that inhalation monitoring 
data would help characterize the health effects of the PMN substance. 
EPA's draft Inhalation Monitoring Data Collection Guidelines are 
available in the docket for this rule under docket ID number EPA-HQ-
OPPT-2012-0277.
    CFR citation: 40 CFR 721.10572.
PMN Number P-08-737
    Chemical name: Magnesium hydroxide surface treated with substituted 
alkoxy silanes (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a flame retardant. Based on test data on analogous respirable, poorly 
soluble particulates, EPA identified concerns for

[[Page 61129]]

lung toxicity and immunotoxicity if the PMN substance is inhaled. For 
the use described in the PMN, and at the annual 100,000 kg production 
volume stated in the PMN, worker inhalation exposure will be minimal 
due to adequate personal protective equipment. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any increase of the annual 100,000 kg production volume, 
or use without workers wearing a NIOSH-certified respirator with an APF 
of at least 10, or use without an appropriate hazard communication 
program may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-
day holding period would help characterize the health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10573.
PMN Number P-09-48
    Chemical name: Alkylcarboxy polyester acrylate reaction products 
with mixed metal oxides (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: August 31, 2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a film 
coating additive. Based on particle size data on the PMN substance, and 
SAR analysis of test data on analogous respirable, poorly soluble 
particulates, EPA identified concerns for inflammation of the lungs, 
lung fibrosis and lung cancer, as well as internal organ effects. In 
addition, based on EcoSAR analysis of test data on analogous acrylate 
substances, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 55 ppb of the PMN substance in surface 
waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I), based on a finding that this substance may 
present an unreasonable risk of injury to human health and the 
environment. To protect against these risks, the consent order 
requires:
    1. Use of impervious gloves (when there is a potential for dermal 
exposure).
    2. Establishment and use of a hazard communication program.
    3. No manufacturing, processing, or use of the PMN substance in 
non-enclosed processes when the PMN substance is in the powder form.
    4. No use involving an application method that generates a vapor, 
mist, aerosol, or a dust.
    5. Transport of the PMN substance to processors using only reusable 
tote tanks cleaned not more than once per year.
    6. Use of the PMN substance only for the confidential use specified 
in the consent order.
    7. Disposal of the PMN substance, any waste streams from 
manufacture of the PMN substance, and any waste streams from processing 
of the PMN substance only by incineration in a Resource Conservation 
and Recovery Act (RCRA)-approved hazardous waste incinerator.
    8. Waste streams from use of the PMN substance must either be 
disposed of by incineration in a RCRA-approved hazardous waste 
incinerator, or be recycled via polymer reclamation.
    9. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test in rats with a post-exposure observation 
period of up to 60 days, including bronchoalveolar lavage fluid 
analysis (OPPTS Test Guideline 870.3465 or OECD Test Guideline 413); 
determination of incineration removal efficiency, full dissolution test 
using transformed PMN substance following incineration (OECD ENV/JM/
MONO(2001)); and particle size distribution, aspect ratio, and 
crystalline structure of transformed PMN substance following 
incineration (OPPTS Test Guideline 830.7520) would help characterize 
the human health effects, environmental fate, and physical chemical 
properties of the PMN substance. The consent order does not require 
submission of this testing at any specified time or production volume. 
However, the consent order's restrictions on manufacture, import, 
processing, distribution in commerce, use, and disposal of the PMN will 
remain in effect until the consent order is modified or revoked by EPA 
based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10574.
PMN Number P-09-480
    Chemical name: 1-Propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-
hydroxy-2-methyl-.
    CAS number: 71868-15-0.
    Basis for action: The PMN states that the use of the substance will 
be used as a co-photoinitiator for ultra-violet (UV)-curable pigmented 
inks, co-photo initiator for photoresists, optical fibers and printed 
plates, and co-photoinitiator for UV-curable coatings and a co-
photoinitiator for UV-curable adhesives and other coatings. Based on 
test data on the PMN substance, EPA identified concerns for 
reproductive toxicity effects from exposure to the PMN substance. In 
addition, based on test data on the PMN substance, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
14 ppb of the PMN substance in surface waters. For the use described in 
the PMN, worker exposure will be minimal due to the use of a NIOSH-
certified respirator with an APF of at least 50, adequate hazard 
communication, and no domestic manufacture of the PMN substance, and 
environmental effects will be minimal as releases of the substance to 
surface waters are not expected. Therefore, EPA has not determined that 
the proposed processing or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance without a NIOSH-certified respirator with an APF of at least 
50, where there is potential inhalation exposure; any domestic 
manufacture; without adequate hazard communication; or any use of the 
substance resulting in surface water concentrations exceeding 14 ppb 
may cause serious health effects and significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(i) and (b)(4)(i).
    Recommended testing: EPA has determined that the results of a two-
generation reproductive toxicity (OECD Test Guideline 416); a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the human health and environmental effects of the PMN 
substance. EPA also recommends that the special considerations for 
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) 
be followed.
    CFR citation: 40 CFR 721.10575.
PMN Number P-09-486
    Chemical name: Polyalkenyl, N,N'-bistriazole (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non 
confidential) use of the substance will be as a lubricant additive. 
Based on EcoSAR analysis of analogous polycationic polymers, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 140 ppb of the PMN substance in surface waters for greater than 
20 days

[[Page 61130]]

per year. This 20-day criterion is derived from partial life cycle 
tests (daphnid chronic and fish early-life stage tests) that typically 
range from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the PMN substance to surface water 
exceed releases from the use described in the PMN. For the use 
described in the PMN, environmental releases did not exceed 140 ppb for 
more than 20 days per year. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that any use of the 
substance other than as described in the PMN may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10576.
PMN Number P-09-636
    Chemical name: Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-
ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1).
    CAS number: 852360-51-1.
    Effective date of TSCA section 5(e) consent order: June 4, 2010.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
substance will be used as a chemical intermediate. EPA has identified 
health and environmental concerns because the substance may be a PBT 
chemical, based on physical/chemical properties of the PMN substance, 
as described in the New Chemical Program's PBT category. EPA estimates 
that the PMN substance will persist in the environment more than two 
months and estimates a bioaccumulation factor of greater than or equal 
to 5,000. Also, based on test data on the PMN substance and SAR 
analysis for anilines, EPA predict toxicity to aquatic organisms at 
concentrations that exceed 1 ppb and developmental toxicity to workers 
from exposures during uses other than as a site-limited chemical 
intermediate. The consent order was issued under TSCA section 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the consent order 
requires:
    1. Establishment and use of a hazard communication program.
    2. Use of the PMN substance only as a site-limited intermediate.
    3. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of human 
health, aquatic toxicity, and environmental fate testing would help 
characterize the effects of the PMN substance. The PMN submitter has 
agreed not to exceed the first production volume limit of 15,000 kgs 
prior to submitting testing to determine the log Kow value (by either 
the liquid chromatography test (OPPTS Test Guideline 830.7575) or the 
generator column method (OPPTS Test Guideline 830.7560)); and the ready 
biodegradability test (OPPTS Test Guideline 835.3110) by any of six 
methods described in the consent order: Depending on the results of the 
first tier testing, the PMN submitter has agreed not to exceed the 
second production volume limit of 170,000 kgs prior to submitting 
testing to determine biodegradation and bioaccumulation potential. 
Further, depending upon the results of the second tier testing, the PMN 
submitter has agreed not to exceed the third production volume limit of 
496,000 kgs prior to submitting: a combined repeated dose toxicity test 
with a reproductive/developmental toxicity screening test (OECD Test 
Guideline 422) in rats; a mammalian erythrocyte micronucleus test 
(OPPTS Test Guideline 870.5395) via the intraperitoneal route; a 
sediment/water microcosm biodegradation test (OPPTS Test Guideline 
835.3180); fish early-life stage toxicity test (OPPTS Test Guideline 
850.1400); and a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300).
    CFR citation: 40 CFR 721.10577.
PMN Number P-10-231
    Chemical name: Unsaturated polyester imide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance will 
be as electrical insulating varnish for motors, generators and 
transformers. Based on EcoSAR analysis of aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 52 ppb of the PMN substance in surface waters. As described in 
the PMN, the substance is not released to surface waters. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance resulting in surface 
water concentrations exceeding 52 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline: 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline: 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the special considerations for conducting aquatic laboratory studies 
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10578.
PMN Number P-10-367
    Chemical name: Carbon black derived from the pyrolysis of rubber 
tire shreds (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: May 16, 2011.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as carbon black 
for general industrial use. Based on test data on carbon black and SAR 
analysis of test data on analogous respirable, poorly soluble 
particulates, EPA identified concerns for immunotoxicity, pulmonary 
toxicity, and carcinogenicity. In addition, based on aquatic toxicity 
data on carbon black, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 1,000 ppb of the PMN substance in 
surface waters. The consent order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I), based on a finding that this 
substance may present an unreasonable risk of injury to human health 
and the environment. To protect against these risks, the consent order 
requires:
    1. Manufacture of the PMN substance using only the process 
described in the PMN.
    2. Manufacturing, processing, or use of the PMN substance in 
compliance with the Occupational Safety and Health Administration 
(OSHA) Permissible Exposure Limit (PEL) for carbon black of 3.5 mg/
m\3\.
    3. Manufacture of the PMN substance to meet the NIOSH recommended 
time weighted average (TWA) for polyaromatic hydrocarbons (PAH) in 
carbon black of 0.1 mg/m\3\ as described in the NIOSH Pocket Guide to 
Chemical

[[Page 61131]]

Hazards Appendix C (see https://www.cdc.gov/niosh/npg/nengapdza.html).
    4. Submission of data demonstrating compliance with the NIOSH TWA 
for PAH as described in the testing section of the consent order.
    5. No release of the PMN substance into the waters of the United 
States.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
human health testing would help characterize the human health effects 
of the PMN substance. The PMN submitter has agreed not to exceed the 
confidential production volume specified in the consent order prior to 
performing a 90-day inhalation toxicity test (OPPTS Test Guideline 
870.3465) with (1) a post-exposure observation period of up to 3 
months; (2) bronchoalveolar lavage fluid (BALF) analysis, aggregate/
agglomeration state, shape, size/size particle distribution and surface 
properties of materials as administered; (3) aggregation/agglomeration 
state, shape, size/size particle distribution; and surface properties 
of materials of the delivered materials after administration; and (4) 
determination of cardiovascular toxicity, heart histopathology, and 
data on pulmonary deposition. Further, the PMN submitter must submit 
additional worker exposure monitoring data to determine whether worker 
exposures exceed the NIOSH REL for PAH. In addition, EPA has determined 
that the results of a 2-year carcinogenicity test (OPPTS Test Guideline 
870.4300) would help characterize the human health effects of the PMN 
substance. The consent order does not require submission of this test 
at any specified time or production volume. However, the consent 
order's restrictions on manufacture, import, processing, distribution 
in commerce, use, and disposal of the PMN will remain in effect until 
the consent order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citation: 40 CFR 721.10579.
PMN Number P-10-452
    Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha'-
[1,4-cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-.
    CAS number: 1220986-58-2.
    Basis for action: The PMN states that the use for this substance 
will be as an epoxy curing agent. Based on EcoSAR on analogous 
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 98 ppb of the PMN substance in surface 
waters. As described in the PMN notice, releases of the PMN substance 
are not expected to result in surface water concentrations that exceed 
98 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 98 ppb, 
may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity 
test, freshwater and marine (OPPTS Test Guideline: 850.1075); an 
aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline: 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10580.
PMN Numbers P-10-524 and P-10-525
    Chemical names: Brominated polyurethane prepolymers of methylene 
diphenyl diisocyanate (MDI) (generic).
    CAS numbers: Not available.
    Basis for action: The consolidated PMN states that the generic 
(non-confidential) use of the substances will be as components of 
polyurethane coatings for non-consumer use. Based on test data on 
analogous isocyanates, EPA identified concerns for dermal 
sensitization, respiratory sensitization, and irritation. For the non-
consumer use described in the PMNs, worker inhalation exposures will be 
minimal due to the use of a NIOSH-certified respirator with an APF of 
at least 10. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances without a NIOSH-certified respirator with an APF of at least 
10, where there is a potential of inhalation exposures, or any consumer 
use of the substances may result in human exposures which may cause 
serious health effects. Based on this information, the PMN substances 
meet the concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS 870.3465) in rodents would help 
characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10581.
PMN Number P-10-571
    Chemical name: Quaternary ammonium compound (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an inhibitor for oil 
field applications. Based on EcoSAR on analogous cationic surfactants, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 47 ppb of the PMN substance in surface waters. As described 
in the PMN, releases of the PMN substance are not expected to result in 
surface water concentrations that exceed 47 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 47 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075); 
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental and fate 
effects of the PMN substance. EPA also recommends that the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10582.
PMN Number P-10-588
    Chemical name: Benzenamine, 4,4'-[1,3-phenylenebis(1-
methylethylidene)]bis-.
    CAS number: 2687-27-6.
    Basis for action: The PMN states that the use will be as a 
precursor to a polyimide resin. Based on SAR analysis of test data on 
analogous aromatic amines, EPA identified concerns for chronic organ 
effects, developmental toxicity and reproductive toxicity from 
exposures to the PMN substance. In addition, based on EcoSAR analysis 
of test data on analogous aromatic amines, EPA predicts toxicity to 
aquatic organisms at concentrations that exceed

[[Page 61132]]

1 ppb of the PMN substance in surface waters. As described in the PMN, 
inhalation exposures are expected to be minimal due to the use of a 
NIOSH-certified particulate respirator with an APF of at least 1,000 
and releases to surface waters are not expected. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance without a NIOSH-certified 
particulate respirator with an APF of at least 1,000, where there is 
potential for inhalation exposures, or any use of the substance 
resulting in surface water concentrations exceeding 1 ppb may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a log 
Kow test (OPPTS Test Guideline 830.7550, 830.7560 or 830.7570; or OECD 
Test Guideline 123); a ready biodegradability test (OPPTS Test 
Guideline 835.3110); and a combined repeated dose toxicity with the 
reproduction/development toxicity screening test (OPPTS Test Guideline 
835.3650) would help characterize the human health and environmental 
effects of the PMN substance.
    CFR citation: 40 CFR 721.10583.
PMN Number P-11-29
    Chemical name: Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-.
    CAS number: 1892-03-1.
    Basis for action: The PMN states that the substance will be used as 
a dry etching agent for production of semiconductors. Based on test 
data on the PMN substance and SAR analysis of test data on analogous 
halogenated hydrocarbons, EPA identified concerns for chronic toxicity 
from exposure to the PMN substance. In addition, based on EcoSAR 
analysis of analogous neutral organic compounds, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 2 ppb of 
the PMN substance in surface waters for greater than 20 days per year. 
This 20-day criterion is derived from partial life cycle tests (daphnid 
chronic and fish early-life stage tests) that typically range from 21 
to 28 days in duration. EPA predicts toxicity to aquatic organisms may 
occur if releases of the PMN substance to surface water exceed releases 
from the use described in the PMN. Significant exposures are not 
expected at a production volume of less than 10,000 kg per year. In 
addition, there is no consumer use or domestic manufacture for the PMN 
substance. Further, for the use described in the PMN, environmental 
releases did not exceed 2 ppb for more than 20 days per year. 
Therefore, EPA has not determined that the proposed processing or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that any domestic manufacture; any use of the substance other 
than as a dry etching agent for production of semiconductors; any use 
in a consumer product; or exceedance of the annual import limit of 
10,000 kg per year could change exposure potential and may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(3)(i), (b)(3)(ii), (b)(4)(i), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day repeated dose inhalation test (OPPTS Test Guideline 870.3465); a 
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400); 
and a daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) 
would help characterize the human health and environmental effects of 
the PMN substance. EPA also recommends that the special considerations 
for conducting aquatic laboratory studies (OPPTS Test Guideline 
850.1000) be followed.
    CFR citation: 40 CFR 721.10584.
PMN Numbers P-11-43 and P-11-44
    Chemical names: (P-11-43) Disiloxane, 1-butyl-1,1,3,3-tetramethyl- 
and (P-11-44) Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl-.
    CAS numbers: (P-11-43) 121263-51-2 and (P-11-44) 4619-08-3.
    Basis for action: The PMN states that the use of the substances 
will be as reducing agents for organic substrates and as chemical 
intermediates. Based on EcoSAR analysis of test data on analogous 
neutral organic compounds, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 ppb of the PMN substances in 
surface waters. As described in the PMNs, the substances are not 
released to surface waters. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substances may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substances resulting in surface water concentrations exceeding 1 
ppb may cause significant adverse environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substances. EPA also 
recommends that the special considerations for conducting aquatic 
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citations: 40 CFR 721.10585 (P-11-43) and 40 CFR 721.18586 (P-
11-44).
PMN Number P-11-81
    Chemical name: 1H-Pyrazole, 3,4-dimethyl-.
    CAS number: 2820-37-3.
    Basis for action: The PMN states that the use of the substance will 
be as an intermediate. Based on EcoSAR analysis of test data on 
analogous pyrazoles, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 19 ppb of the PMN substance in 
surface waters. As described in the PMN, the substance is not released 
to surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 19 ppb 
may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of: either 
a ready biodegradability test (OPPTS Test Guideline 835.3110) or a 
porous pot test (OPPTS Test Guideline 835.3220); a fish acute toxicity 
test, freshwater and marine (OPPTS Test Guideline 850.1075); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline 
850.4500) would help characterize the environmental and fate effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10587.
PMN Number P-11-98
    Chemical name: Phenol, 2-[1-[[3-(1H-imidazol-1-
yl)propyl]imino]ethyl]-.
    CAS number: 1253404-90-8.
    Basis for action: The PMN states that the generic (non-
confidential) use will be as an epoxy catalyst. Based on EcoSAR 
analysis of test data on analogous phenols, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb of

[[Page 61133]]

the PMN substance in surface waters. As described in the PMN, the 
substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guidelines 835.3110); a hydrolysis as 
a function of pH test (OPPTS Test Guideline 835.2110); an aerobic 
treatment simulation test (OECD Test Guideline 303A); a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guidelines 850.1075); 
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
Test Guideline 850.1010); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental and fate 
effects of the PMN substance. EPA also recommends that the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10588.
PMN Numbers P-11-106 and P-11-107
    Chemical names: (P-11-106) Unsaturated fatty acids, amides with 
polyethylenepolyamine (generic) and (P-11-107) Fatty acids, amides with 
triethylentetramine (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that substances will be used as a 
surfactant in asphalt emulsion (P-11-106) and an anti-stripping agent 
in asphalt (P-11-107). Based on EcoSAR analysis of test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 ppb of the PMN substances in 
surface waters. As described in the PMN, the substances are not 
released to surface waters. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substances may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substances resulting in surface water concentrations exceeding 1 
ppb may cause significant adverse environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the special considerations for conducting aquatic laboratory studies 
(OPPTS Test Guideline 850.1000) be followed.
    CFR citations: 40 CFR 721.10589 (P-11-106) and 40 CFR 721.10590 (P-
11-107).
PMN Number P-11-110
    Chemical name: Tertiary ammonium compound (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an inhibitor for oil 
field applications. Based on EcoSAR analysis of test data on analogous 
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage test, freshwater and marine (OPPTS Test Guideline 
850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300); and a mysid chronic toxicity test (OPPTS Test Guideline 
850.1350) in salt water would help characterize the environmental 
effects of the PMN substance. EPA also recommends that the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10591.
PMN Number P-11-130
    Chemical name: 1-Butanol, 4-amino-.
    CAS number: 13325-10-5.
    Basis for action: The PMN states that the PMN substance will be 
used as an intermediate. Based on SAR analysis of test data on 
analogous aliphatic amines, EPA identified concerns for neurotoxicity, 
liver toxicity, and kidney toxicity from exposures to the PMN 
substance. For the intermediate use described in the PMN, significant 
worker exposures are not expected. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, use of 
the substance other than as an intermediate may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); an acute oral 
toxicity test (OPPTS Test Guideline 870.1100); a repeated dose 28-day 
oral toxicity in rodents (OPPTS Test Guideline 870.3050) including a 
neurotoxicity functional observational battery, as described in the 
neurotoxicity screening battery (OPPTS Test Guideline 870.6200); a 
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); and a 
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) 
via the intraperitoneal route would help characterize the human health 
and fate effects of the PMN substance.
    CFR citation: 40 CFR 721.10592.
PMN Number P-11-162
    Chemical name: 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-
dioxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester.
    CAS number: 70293-55-9.
    Basis for action: The PMN states that the substance will be uses as 
an adhesive monomer. Based on EcoSAR analysis of test data on analogous 
esters and methacrylates, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 20 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 20 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 20 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute

[[Page 61134]]

toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and 
an algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance. EPA also 
recommends that the special considerations for conducting aquatic 
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10593.
PMN Number P-11-173
    Chemical name: Hexanedioic acid, polymer with 2,2-dimethyl-1,3-
propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-
methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and 1,1'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with 
triethylamine.
    CAS number: 1138156-39-4.
    Basis for action: The PMN states that the generic (non-
confidential) use for the substance will be as a coating for wooden 
floors. Based on EcoSAR analysis of test data on analogous amphoteric 
polymers, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 150 ppb for the PMN substance in surface 
waters. As described in the PMN, releases of the substance to surface 
waters are not expected to result in surface water concentrations that 
exceed 150 ppb, due to pretreatment by primary, secondary, and tertiary 
waste treatment, or treatment in a lined, self-contained solar 
evaporation pond. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 150 ppb 
may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the special considerations for conducting aquatic laboratory studies 
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10594.
PMN Number P-11-230
    Chemical name: Octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl 
sulfate (1:1).
    CAS number: 1256282-88-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an antistatic agent for 
acrylic yarn. Based on EcoSAR analysis of test data on cationic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 4 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 4 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075) in clean dilution water; a fish acute toxicity test mitigated 
by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS Test Guideline 
850.1010); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
would help characterize the environmental effects of the PMN substance. 
EPA also recommends that the special considerations for conducting 
aquatic laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10595.
PMN Number P-11-234
    Chemical name: Oligomeric phenolic ether (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
Based on EcoSAR analysis of test data on analogous neutral organic 
chemicals, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects and result in 
substantial human exposure via drinking water or fish ingestion. Based 
on this information, the PMN substance meets the concern criteria at 
Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3110); an acute 
toxicity test (OPPTS Test Guideline 870.1000); a mammalian erythrocyte 
micronucleus test (OPPTS Test Guideline 870.5395); a repeated dose 28-
day oral toxicity test in rodents (OPPTS Test Guideline 870.3050); a 
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a fish 
BCF test (OPPTS Test Guideline 850.1730); a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400); a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300); and an algal toxicity 
test (OCSPP Test Guideline 850.4500) would help characterize the human 
health and environmental effects of the PMN substance. EPA also 
recommends that the special considerations for conducting aquatic 
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10596.
PMN Number P-11-252
    Chemical name: Benzeneacetonitrile, alkoxy-
[[(alkylsulfonyl)oxy]imino]- (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a photographic chemical. 
Based on EcoSAR analysis of test data on analogous vinyl/allyl 
nitriles, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300): and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance. EPA also

[[Page 61135]]

recommends that the special considerations for conducting aquatic 
laboratory studies (OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10597.
PMN Numbers P-11-270, P-11-271, P-11-272, P-11-273, and P-11-274
    Chemical names: (P-11-270) Lead strontium titanium zirconium oxide; 
(P-11-271) Calcium cobalt lead titanium tungsten oxide; (P-11-272) 
Calcium cobalt lead strontium titanium tungsten oxide; (P-11-273) 
Lanthanum lead titanium zirconium oxide; and (P-11-274) Lead niobium 
titanium zirconium oxide.
    CAS numbers: (P-11-270) 61461-40-3; (P-11-271) 1262279-31-1; (P-11-
272) 1262279-30-0; (P-11-273) 1227908-26-0; and (P-11-274) 56572-83-9.
    Basis for action: The PMNs state that the substances will be used 
as piezoelectric ceramics for active and passive underwater acoustic 
systems. Based on test data on lead and SAR analysis of test data on 
analogous respirable, poorly soluble particulates, EPA identified 
concerns for neurobehavioral and other neurological effects, 
cerebrovascular disease, high blood pressure, renal effects, cardiac 
effects, lung effects, neurological effects, hematological effects, 
reproductive toxicity, and immunotoxicity. In addition, based on EcoSAR 
analysis of test data on analogous inorganic lead compounds, EPA 
expects toxicity to aquatic organisms to occur at concentrations that 
exceed an aggregate of 8 ppb of the PMN substances in surface waters. 
For the uses described in the PMNs, worker inhalation exposures are 
expected to be minimal due to use of a NIOSH-certified respirator with 
an APF of at least 50, and releases of the PMN substances are not 
expected to result in an aggregate surface water concentration that 
exceeds 8 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances without the use of a NIOSH-certified respirator with an APF 
of at least 50, where there is a potential for inhalation exposures; 
any use of the substances other than as piezoelectric ceramics for 
active and passive underwater acoustic systems; or any use of the 
substances resulting in an aggregate surface water concentration 
exceeding 8 ppb may cause serious health effects and significant 
adverse environmental effects. Based on this information the PMN 
substances meet the concern criteria at Sec.  721.170 (b)(3)(i) and 
(b)(4)(ii).
    Recommended testing: EPA has determined that inhalation monitoring 
data, collected according to the EPA draft Inhalation Monitoring Data 
Collection Guidelines (located in the docket under docket ID number 
EPA-HQ-OPPT-2012-0277) would help characterize the human health effects 
of the PMN substances.
    CFR citations: 40 CFR 721.10598 (P-11-270); 40 CFR 721.10599 (P-11-
271); 40 CFR 721.10600 (P-11-272); 40 CFR 721.10601 (P-11-273); and 40 
CFR 721.10602 (P-11-274).
PMN Number P-11-280
    Chemical name: Epoxy modified alkyd resin, partially neutralized 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a coating resin. Based on 
EcoSAR analysis of test data on analogous phosphates, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of an 
algal toxicity test (OCSPP Test Guideline 850.4500) without adding 
phosphate would help characterize the environmental effects of the PMN 
substance. EPA also recommends that the special considerations for 
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) 
be followed.
    CFR citation: 40 CFR 721.10603.
PMN Number P-11-447
    Chemical name: Polyetherdiamine (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a gas treatment chemical for the removal of hydrogen sulfide from 
natural gas. Based on EcoSAR analysis of test data on analogous 
aliphatic amines, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 4 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 4 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10604.
PMN Numbers P-11-485, P-11-486, P-11-488, and P-11-489
    Chemical names: (P-11-485) Polyoxyalkylene ether, polymer with 
aliphatic diisocyanate, homopolymer, alkanol-blocked (generic); (P-11-
486) Alkyl substituted alkanediol polymer with aliphatic and alicyclic 
diisocyanates (generic); (P-11-488) Aliphatic diisocyanate, 
homopolymer, alkanol-blocked (generic); and (P-11-489) Aliphatic 
diisocyanate polymer with alkanediol and alkylglycol (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as hardeners for industrial 
coatings. Based on test data on analogous diisocyanates (including TSCA 
section 8(e) data on polymeric MDI), EPA identified concerns for 
oncogenicity. Also, based on test data on the PMN substances, the 
Agency identified concerns for lung and mucous membranes irritation as 
well as sensitization to workers from exposures to the PMN substances. 
For the uses and at the production volumes stated in the PMN, worker 
inhalation exposures will be minimal due to use of a NIOSH-certified 
respirator with an APF of at least 10, and there are no consumer 
exposures.
    Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of these substances may present an unreasonable 
risk. EPA has determined, however, that any use of the substance 
without a NIOSH-certified respirator with an APF of at least 10, where 
there is a potential for

[[Page 61136]]

inhalation exposures; any substantial increase of the annual 
manufacturing and importation volume of 10,000 kgs; or any use of the 
substances in consumer products may cause serious health effects. Based 
on this information, the PMN substances meets the concern criteria at 
Sec.  721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) on PMNs P-
11-485, P-11-486, and either P-11-488 or P-1l-489, would help 
characterize the human health effects of the PMN substances.
    CFR citations: 40 CFR 721.10605 (P-11-485); 40 CFR 721.10606 (P-11-
486); 40 CFR 721.10607 (P-11-488); and 40 CFR 721.105608 (P-11-489).
PMN Number P-11-548
    Chemical name: Imidodicarbonic diamide, N,N'-dibutyl-N',2-bis[4-
[(4-isocyanatophenyl)methyl]phenyl]-.
    CAS number: 1254743-03-7.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer crosslinking 
agent. Based on SAR analysis of test data on analogous diisocyanates, 
EPA identified concerns for oncogenicity, sensitization, lung 
irritation, and mucous membrane irritation from exposure to the PMN 
substance. For the non-consumer use described in the PMN, inhalation 
exposures are not expected as the substance is not applied by a method 
that generates a vapor, mist, or aerosol. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance in consumer products; or any use 
of the substance involving an application method that generates a 
vapor, mist, or aerosol may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) in rats would 
help characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10609.
PMN Numbers P-11-635 and P-11-636
    Chemical names: Toluene diisocyanate, polymers with polyalkylene 
glycol (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as reactants for the 
production of polyurethane elastomers. Based on SAR analysis of test 
data on analogous diisocyanates, EPA identified concerns for 
oncogenicity, irritation to lungs and mucous membranes, and 
sensitization to workers from exposure to the PMN substances. For the 
uses described in the PMNs significant worker exposure is unlikely 
because there are no applications generating a vapor, mist or aerosol, 
and there are no consumer exposures. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of these substances 
may present an unreasonable risk. EPA has determined, however, that use 
of any of the substances in consumer products; or any use of the 
substance involving an application method that generates a vapor, mist, 
or aerosol may cause serious health effects. Based on this information, 
the PMN substances meet the concern criteria at Sec.  721.170 
(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
dermal sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10610.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for 7 of the 78 
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) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  721.160 (see Unit II.).
    In the other 71 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  721.170 were met, as discussed 
in Unit IV.

B. Objectives

    EPA is issuing 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 will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is December 4, 2012 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before November 5, 2012.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before November 5, 2012, EPA will withdraw the relevant sections 
of this direct final rule before its effective date. EPA will then 
issue a proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.

[[Page 61137]]

    This rule establishes SNURs for 78 chemical substances. Any person 
who submits adverse or critical comments, or notice of intent to submit 
adverse or critical comments, must identify the chemical substance and 
the new use to which it applies. EPA will not withdraw a SNUR for a 
chemical substance not identified in the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of 
the Rule

    Significant new use designations for a chemical substance are 
legally established as of the date of publication of this direct final 
rule, October 5, 2012.
    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. TSCA section 5(e) consent orders have 
been issued for 7 chemical substances and the PMN submitters are 
prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which EPA is designating as significant new uses. 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 other 
person may commence such activities without first submitting a PMN. For 
chemical substances for which an NOC has not been submitted at this 
time, EPA concludes that the uses are not ongoing. However, EPA 
recognizes that prior to the effective date of the rule, when chemical 
substances identified in this SNUR are added to the TSCA Inventory, 
other persons may engage in a significant new use as defined in this 
rule before the effective date of the rule. However, 40 of the 78 
chemical substances contained in this rule have CBI chemical 
identities, and since EPA has received a limited number of post-PMN 
bona fide submissions (per Sec. Sec.  720.25 and 721.11), the Agency 
believes that it is highly unlikely that any of the significant new 
uses described in the regulatory text of this rule are ongoing.
    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is 
best served by designating a use as a significant new use as of the 
date of publication of this direct final rule rather than as of the 
effective date of the rule. If uses begun after publication were 
considered ongoing rather than new, it would be difficult for EPA to 
establish SNUR notification requirements because a person could defeat 
the SNUR by initiating the significant new use before the rule became 
effective, and then argue that the use was ongoing before the effective 
date of the rule. Thus, persons who begin commercial manufacture, 
import, or processing of the chemical substances regulated through this 
SNUR will have to cease any such activity before the effective date of 
this rule. To resume their activities, these persons would have to 
comply with all applicable SNUR notification requirements and wait 
until the notice review period, including any extensions expires.
    EPA has promulgated provisions to allow persons to comply with this 
SNUR before the effective date. If a person meets the conditions of 
advance compliance under Sec.  721.45(h), the person is considered 
exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (see Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In cases where EPA issued a 
TSCA section 5(e) consent order that requires or recommends certain 
testing, Unit IV. lists those tests. Unit IV. also lists recommended 
testing for non-section 5(e) SNURs. Descriptions of tests are provided 
for informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' or for guidelines that are not 
currently available on the Web site, EPA has placed a copy of that 
guideline in the public docket. The OECD test guidelines are available 
from the OECD Bookshop at https://www.oecdbookshop.org or Source OECD at 
https://www.sourceoecd.org.
    In the TSCA section 5(e) consent orders for 7 of the chemical 
substances regulated under this rule, EPA has established production 
volume 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 toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Under recent TSCA section 5(e) 
consent orders, each PMN submitter is required to submit each test at 
least 14 weeks (earlier TSCA section 5(e) consent orders required 
submissions at least 12 weeks) before reaching the specified production 
limit. Listings of the tests specified in the TSCA section 5(e) consent 
orders are included in Unit IV. The SNURs contain the same production 
volume limits as the TSCA section 5(e) consent 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, import, or processing.
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim

[[Page 61138]]

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

X. SNUN Submissions

    According to 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. Sec.  721.25 and 720.40. E-PMN software is available 
electronically at https://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances subject to this rule. EPA's complete economic 
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2012-0277.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This rule establishes SNURs for several new chemical substances 
that were the subject of PMNs and, in some cases, TSCA section 5(e) 
consent 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. EPA is amending the table in 40 CFR part 9 to list the OMB 
approval number for the information collection requirements contained 
in this rule. This listing of the OMB control numbers and their 
subsequent codification in the CFR satisfies the display requirements 
of PRA and OMB's implementing regulations at 5 CFR part 1320. This 
Information Collection Request (ICR) was previously subject to public 
notice and comment prior to OMB approval, and given the technical 
nature of the table, EPA finds that further notice and comment to amend 
it is unnecessary. As a result, EPA finds that there is ``good cause'' 
under section 553(b)(3)(B) of the Administrative Procedure Act (5 
U.S.C. 553(b)(3)(B)) to amend this table without further notice and 
comment.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to PRA under OMB control number 
2070-0012 (EPA ICR No. 574). This action does not impose any burden 
requiring additional OMB approval. If an entity were to submit a SNUN 
to the Agency, the annual burden is estimated to average between 30 and 
170 hours per response. This burden estimate includes the time needed 
to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, 
Collection Strategies Division, Office of Environmental Information 
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001. Please remember to include the OMB control 
number in any correspondence, but do not submit any completed forms to 
this address.

C. Regulatory Flexibility Act (RFA)

    On February 18, 2012, EPA certified pursuant to RFA section 605(b) 
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a 
significant economic impact on a substantial number of small entities 
where the following are true:
    1. A significant number of SNUNs would not be submitted by small 
entities in response to the SNUR.
    2. The SNUR submitted by any small entity would not cost 
significantly more than $8,300.
    A copy of that certification is available in the docket for this 
rule.
    This rule is within the scope of the February 18, 2012 
certification. Based on the Economic Analysis discussed in Unit XI. and 
EPA's experience promulgating SNURs (discussed in the certification), 
EPA believes that the following are true:
     A significant number of SNUNs would not be submitted by 
small entities in response to the SNUR.
     Submission of the SNUN would not cost any small entity 
significantly more than $8,300.

Therefore, the promulgation of the SNUR would not have a significant 
economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this rule. As 
such, EPA has determined that this rule does not impose any

[[Page 61139]]

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

F. Executive Order 13175

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

G. Executive Order 13045

    This action 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 action 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 action is not expected to affect energy supply, distribution, or 
use and because this action is not a significant regulatory action 
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898

    This action 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).

XIV. Congressional Review Act

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

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

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

    Dated: September 24, 2012.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.

    Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

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

     Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 
2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 
9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 
1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 
CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 
300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-
2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 
7542, 9601-9657, 11023, 11048.


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


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  Control
                    40 CFR  citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
721.10426...............................................       2070-0012
721.10537...............................................       2070-0012
721.10538...............................................       2070-0012
721.10539...............................................       2070-0012
721.10540...............................................       2070-0012
721.10541...............................................       2070-0012
721.10542...............................................       2070-0012
721.10543...............................................       2070-0012
721.10544...............................................       2070-0012
721.10545...............................................       2070-0012
721.10546...............................................       2070-0012
721.10547...............................................       2070-0012
721.10548...............................................       2070-0012
721.10549...............................................       2070-0012
721.10550...............................................       2070-0012
721.10551...............................................       2070-0012
721.10552...............................................       2070-0012
721.10553...............................................       2070-0012
721.10554...............................................       2070-0012
721.10555...............................................       2070-0012
721.10556...............................................       2070-0012
721.10557...............................................       2070-0012
721.10558...............................................       2070-0012
721.10559...............................................       2070-0012
721.10560...............................................       2070-0012
721.10561...............................................       2070-0012
721.10562...............................................       2070-0012
721.10563...............................................       2070-0012
721.10564...............................................       2070-0012
721.10565...............................................       2070-0012
721.10566...............................................       2070-0012
721.10567...............................................       2070-0012
721.10568...............................................       2070-0012
721.10569...............................................       2070-0012
721.10570...............................................       2070-0012
721.10571...............................................       2070-0012
721.10572...............................................       2070-0012
721.10573...............................................       2070-0012
721.10574...............................................       2070-0012
721.10575...............................................       2070-0012
721.10576...............................................       2070-0012
721.10577...............................................       2070-0012
721.10578...............................................       2070-0012
721.10579...............................................       2070-0012
721.10580...............................................       2070-0012
721.10581...............................................       2070-0012
721.10582...............................................       2070-0012
721.10583...............................................       2070-0012
721.10584...............................................       2070-0012
721.10585...............................................       2070-0012
721.10586...............................................       2070-0012
721.10587...............................................       2070-0012
721.10588...............................................       2070-0012
721.10589...............................................       2070-0012
721.10590...............................................       2070-0012
721.10591...............................................       2070-0012
721.10592...............................................       2070-0012
721.10593...............................................       2070-0012
721.10594...............................................       2070-0012
721.10595...............................................       2070-0012
721.10596...............................................       2070-0012
721.10597...............................................       2070-0012
721.10598...............................................       2070-0012
721.10599...............................................       2070-0012
721.10600...............................................       2070-0012

[[Page 61140]]

 
721.10601...............................................       2070-0012
721.10602...............................................       2070-0012
721.10603...............................................       2070-0012
721.10604...............................................       2070-0012
721.10605...............................................       2070-0012
721.10606...............................................       2070-0012
721.10607...............................................       2070-0012
721.10608...............................................       2070-0012
721.10609...............................................       2070-0012
721.10610...............................................       2070-0012
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec.  721.10426 to subpart E to read as follows:


Sec.  721.10426  1-Octadecanol, manuf. of, distn. lights, fractionation 
heavies, distn. lights.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-octadecanol, 
manuf. of, distn. lights, fractionation heavies, distn. lights (PMN P-
00-535; CAS No. 243640-46-2) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j)(feedstock for esterification).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
5. Add Sec.  721.10537 to subpart E to read as follows:


Sec.  721.10537  Acrylate ester (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
acrylate ester (PMN P-01-579) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=50).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
6. Add Sec.  721.10538 to subpart E to read as follows:


Sec.  721.10538  Phosphonium, tetrakis (hydroxymethyl)-, chloride 
(1:1), reaction products with 1-tetradecanamine and urea.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphonium, 
tetrakis(hydro xymethyl)-, chloride (1:1), reaction products with 1-
tetradecanamine and urea (PMN P-02-161; CAS No. 359406-89-6) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
7. Add Sec.  721.10539 to subpart E to read as follows:


Sec.  721.10539  Bis[phenyl-2H-1,3-benzoxazine]derivative (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bis[phenyl-2H-1,3-benzoxazine]derivative (PMN P-02-653) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
8. Add Sec.  721.10540 to subpart E to read as follows:


Sec.  721.10540  1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-
benzenedimethanamine, N-(2-phenylethyl) derivs. (PMN P-02-984; CAS No. 
404362-22-7) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=5).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
9. Add Sec.  721.10541 to subpart E to read as follows:


Sec.  721.10541  5,2,6-(Iminomethenimino)-1H-imidazo[4,5-b]pyrazine, 
octahydro-1,3,4,7,8,10-hexanitro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 5,2,6-
(iminomethenimino)-1H-imidazo[4,5-b]pyrazine, octahydro-1,3,4,7,8,10-
hexanitro- (PMN P-03-481; CAS No. 135285-90-4) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (b)(concentration set at 0.1 
percent), and (c). The following respirator meets the requirements of 
Sec.  721.63(a)(4): a

[[Page 61141]]

National Institute for Occupational Safety and Health (NIOSH)-certified 
air purifying respirator with a particulate P100 vapor cartridge or 
canister.
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(2)(v), (b)(2)(v), and (c)(2)(v).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), 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.

0
10. Add Sec.  721.10542 to subpart E to read as follows:


Sec.  721.10542  Dodecanedioic acid, 1,12-dimethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as dodecanedioic acid, 
1,12-dimethyl ester (PMN P-03-624; CAS No. 1731-79-9) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=30).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
11. Add Sec.  721.10543 to subpart E to read as follows:


Sec.  721.10543  Oxetane, 3-methyl-3-[(2,2,3,3,3-
pentafluoropropoxy)methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxetane, 3-methyl-
3-[(2,2,3,3,3-pentafluoropropoxy)methyl]- (PMN P-04-79; CAS No. 449177-
94-0) 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), (a)(3), (b)(concentration set at 0.1 
percent), and (c).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a) through (e) 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.
0
12. Add Sec.  721.10544 to subpart E to read as follows:


Sec.  721.10544  Oxetane, 3-methyl-3-[[(3,3,4,4,5,5,6,6,6-
nonafluorohexyl)oxy]methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxetane, 3-methyl-
3-[[(3,3,4,4,5,5,6,6,6-nonafluorohexyl)oxy]methyl]- (PMN P-04-80; CAS 
No. 475678-78-5) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this rule do not apply to quantities of the PMN after 
it has been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (b)(concentration set at 
0.1 percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(1)(viii), (g)(2)(i), (g)(2)(v), (g)(3)(i), 
(g)(3)(ii), (g)(4)(ii), and (g)(5).
    (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)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (f), (g), (h), (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 (a)(2)(iii) of this 
section.

0
13. Add Sec.  721.10545 to subpart E to read as follows:


Sec.  721.10545  Aminotriazine modified cresol novolec resin (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aminotriazine modified cresol novolec resin (PMN P-04-313) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 10).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
14. Add Sec.  721.10546 to subpart E to read as follows:


Sec.  721.10546  Pentenylated polyethylene glycol sulfate salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
pentenylated polyethylene glycol sulfate salt (PMN P-04-340) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
15. Add Sec.  721.10547 to subpart E to read as follows:


Sec.  721.10547  Dialkyl dimethyl ammonium methylcarbonate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as dialkyl 
dimethyl

[[Page 61142]]

ammonium methylcarbonate (PMN P-04-587) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
16. Add Sec.  721.10548 to subpart E to read as follows:


Sec.  721.10548  Mixed alkyl phosphate esters alkoxylated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
alkyl phosphate esters alkoxylated (PMN P-04-624) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 40).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
17. Add Sec.  721.10549 to subpart E to read as follows:


Sec.  721.10549  Ethane, 1,1,2,2-tetrafluoro-1-(2,2,2-
trifluoroethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethane, 1,1,2,2-
tetrafluoro-1-(2,2,2-trifluoroethoxy)- (PMN P-04-635; CAS No. 406-78-0) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (j)(cleaning electronic components; 
precision cleaning; dewatering of electronic components and other parts 
following aqueous cleaning; and carrier/lubricant coating for hard disk 
drives and other precision parts), and (l).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
0
18. Add Sec.  721.10550 to subpart E to read as follows:


Sec.  721.10550  Rare earth salt of a carboxylic acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as rare 
earth salt of a carboxylic acid (PMN P-05-324) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 5).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (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 (a)(2)(i) of this 
section.

0
19. Add Sec.  721.10551 to subpart E to read as follows:


Sec.  721.10551  Bisphenol S mono ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
bisphenol S mono ether (PMN P-05-613) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f) and (j).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(b)(4) and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (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 (a)(2)(i) of this 
section.

0
20. Add Sec.  721.10552 to subpart E to read as follows:


Sec.  721.10552  Oxirane, 2-(1-chlorocyclopropyl)-2-[(2-
chlorophenyl)methyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2-(1-
chlorocyclopropyl)-2-[(2-chlorophenyl)methyl]- (PMN P-05-774; CAS No. 
134818-68-1) 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), (a)(3), (b)(concentration set at 0.1 
percent), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(h).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=2).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (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.

0
21. Add Sec.  721.10553 to subpart E to read as follows:

[[Page 61143]]

Sec.  721.10553  Potassium titanium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as potassium titanium 
oxide (PMN P-06-149; CAS No. 12673-69-7) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this rule do not apply to 
quantities of the PMN substance that have been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4) and (a)(6)(i). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 10 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose- fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (1) As an alternative to the respiratory requirements listed here, 
a manufacturer, importer, or processor may choose to follow the new 
chemical exposure limit (NCEL) provisions listed in the TSCA section 
5(e) consent order for this substance. The NCEL is 1.5 mg/m\3\. Persons 
who wish to pursue NCELs as an alternative to the Sec.  721.63 
respirator requirements may request to do so under 40 CFR 721.30. 
Persons whose Sec.  721.30 requests to use the NCELs approach are 
approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (2) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (f), (g)(1)(ii), (g)(2)(ii), 
(g)(2)(iv)(use respiratory protection or maintain workplace airborne 
concentrations at or below an 8-hour time-weighted average of 1.5 mg/
m\3\), and (a)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k)(manufacture of the substance with a 
particle size of at least 100 nanometers).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (f), (g), (h), 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.

0
22. Add Sec.  721.10554 to subpart E to read as follows:


Sec.  721.10554  Iso-tridecanol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as iso-
tridecanol (PMN P-06-153) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the PMN substance with 
no greater than an average of three branches per alkyl unit, and 
routine analysis of representative samples for compliance with the 
chemical composition section of the consent order).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
23. Add Sec.  721.10555 to subpart E to read as follows:


Sec.  721.10555  Benzoic acid nonyl ester, branched and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzoic acid nonyl 
ester, branched and linear (PMN P-06-370; CAS No. 670241-72-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 
percent), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(b)(4) and (c)(4) (N=6).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (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.

0
24. Add Sec.  721.10556 to subpart E to read as follows:


Sec.  721.10556  Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-
1-yl) -.omega.-hydroxy-,C12-15-alkyl ethers.

    (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-
,C12-15-alkyl ethers (PMN P-06-450; CAS No. 675869-02-0) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s)(45,000 kilograms cumulative production 
volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) 
-.omega.-hydroxy-,C12-15-alkyl ethers (PMN P-06-450; CAS No. 
675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-
yl) -.omega.-hydroxy-,C10-16-alkyl ethers (PMN P-06-451; CAS 
No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-
propen-1-yl) -.omega.-hydroxy-,C12-16-alkyl ethers (PMN P-
06-452; CAS No. 675869-05-3)).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 61144]]


0
25. Add Sec.  721.10557 to subpart E to read as follows:


Sec.  721.10557  Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-
1-yl) -.omega.-hydroxy-,C10-16-alkyl ethers.

    (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-
,C10-16-alkyl ethers (PMN P-06-451; CAS No. 620610-66-4) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s)(45,000 kilograms cumulative production 
volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) 
-.omega.-hydroxy-,C12-15-alkyl ethers (PMN P-06-450; CAS No. 
675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-
yl) -.omega.-hydroxy-,C10-16-alkyl ethers (PMN P-06-451; CAS 
No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-
propen-1-yl) -.omega.-hydroxy-,C12-16-alkyl ethers (PMN P-
06-452; CAS No. 675869-05-3)).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
26. Add Sec.  721.10558 to subpart E to read as follows:


Sec.  721.10558  Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-
1-yl) -.omega.-hydroxy-,C12-16-alkyl ethers.

    (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-
,C12-16-alkyl ethers (PMN P-06-452; CAS No. 675869-05-3) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s)(45,000 kilograms cumulative production 
volume of: Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-yl) 
-.omega.-hydroxy-,C12-15-alkyl ethers (PMN P-06-450; CAS No. 
675869-02-00); Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-propen-1-
yl) -.omega.-hydroxy-,C10-16-alkyl ethers (PMN P-06-451; CAS 
No. 620610-66-4); and Poly(oxy-1,2-ethanediyl), .alpha.- (2-methyl-2-
propen-1-yl) -.omega.-hydroxy-,C12-16-alkyl ethers (PMN P-
06-452; CAS No. 675869-05-3)).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
27. Add Sec.  721.10559 to subpart E to read as follows:


Sec.  721.10559  Morpholine, 4-C6-12 acyl derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as morpholine, 4-
C6-12 acyl derivs. (PMN P-06-793; CAS No. 887947-29-7) 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 Sec.  
721.63 (a)(1), (a)(2)(i), (a)(3), (b)(concentration set at 0.1 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), (g)(1)(systemic effects), (g)(2)(i), and (g)(2)(v).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (h) 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.

0
28. Add Sec.  721.10560 to subpart E to read as follows:


Sec.  721.10560  Alkanoldioic dialkyl esters (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkanoldioic dialkyl esters (PMNs P-07-143 and P-07-144) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
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 (a)(2)(i) of this 
section.

0
29. Add Sec.  721.10561 to subpart E to read as follows:


Sec.  721.10561  Substituted phenol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted phenol (PMN P-07-327) 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) Hazard communication program. Requirements as specified as 
Sec.  721.72 (a), (b), (c), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), 
and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified as Sec.  721.80(q).
    (iii) Release to water. Requirements as specified as Sec.  721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (f), (g), (h), (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 (a)(2)(ii) of this 
section.

0
30. Add Sec.  721.10562 to subpart E to read as follows:

[[Page 61145]]

Sec.  721.10562  Aluminum trihydrate and silane homopolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aluminum trihydrate and silane homopolymer (PMN P-07-375) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s)(100,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
31. Add Sec.  721.10563 to subpart E to read as follows:


Sec.  721.10563  2-Oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-
N-(2-oxiranylmethyl)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 2-
oxiranemethanamine, N-[3-(2-oxiranylmethoxy)phenyl]-N-(2-
oxiranylmethyl)- (PMN P-07-496; CAS No. 71604-74-5) 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), (a)(3), (b)(concentration set at 0.1 
percent), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j)(preparation of pre-impregnated cloth/
fiber tapes for aerospace composite articles).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), 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.

0
32. Add Sec.  721.10564 to subpart E to read as follows:


Sec.  721.10564  Mixed amino diaryl sulfone isomers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
amino diaryl sulfone isomers (PMN P-08-39) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o), (v)(1), (w)(1), and (x)(1).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=8).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (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.

0
33. Add Sec.  721.10565 to subpart E to read as follows:


Sec.  721.10565  Ethanol, 2,2'-[[3-[(2-
hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) 
derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as ethanol, 2,2'-[[3-
[(2-hydroxyethyl)amino]propyl]imino]bis-, N-(hydrogenated tallow alkyl) 
derivs. (PMN P-08-263; CAS No. 90367-25-2) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
34. Add Sec.  721.10566 to subpart E to read as follows:


Sec.  721.10566  1-Propanamine, N-(1-methylethyl) -,3-(C12-15-alkyloxy) 
derivs.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-propanamine, N-
(1-methylethyl)-,3- (C12-15-alkyloxy) derivs (PMN P-08-292; 
CAS No. 944835-56-7) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
35. Add Sec.  721.10567 to subpart E to read as follows:


Sec.  721.10567  Amidoamine salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
amidoamine salt (PMN P-08-300) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
36. Add Sec.  721.10568 to subpart E to read as follows:


Sec.  721.10568  Diethanolamine salt of polymeric acid (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diethanolamine salt of polymeric acid (PMN P-08-464) is

[[Page 61146]]

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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=4).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
37. Add Sec.  721.10569 to subpart E to read as follows:


Sec.  721.10569  Tricyclic quaternary amine salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tricyclic quaternary amine salt (PMN P-08-471) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=100).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
38. Add Sec.  721.10570 to subpart E to read as follows:


Sec.  721.10570  Cyclic amine reaction product with acetophenone and 
formaldehyde acid salt (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cyclic 
amine reaction product with acetophenone and formaldehyde acid salt 
(PMN P-08-537) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=8).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
39. Add Sec.  721.10571 to subpart E to read as follows:


Sec.  721.10571  1,3-Benzenediol, polymer with 1,1'-
methylenebis[isocyanatobenzene].

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,3-benzenediol, 
polymer with 1,1'-methylenebis[isocyanatobenzene] (PMN P-08-611; CAS 
No. 1008753-84-1) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j)(manufacture with all isocyanate groups 
reacted within the polymer).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (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 (a)(2)(i) of this 
section.

0
40. Add Sec.  721.10572 to subpart E to read as follows:


Sec.  721.10572  Benzamide, N-[[4-
[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzamide, N-[[4-
[(cyclopropylamino)carbonyl]phenyl]sulfonyl]-2-methoxy- (PMN P-08-680; 
CAS No. 221667-31-8) 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), (a)(3), (a)(4), (a)(6)(i), (b)(concentration 
set at 0.1 percent), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 10 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), (g)(1)(iv), (g)(2)(iv), and (g)(2)(v).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) through (h) 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.

0
41. Add Sec.  721.10573 to subpart E to read as follows:


Sec.  721.10573  Magnesium hydroxide surface treated with substituted 
alkoxysilanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
magnesium hydroxide surface treated with substituted alkoxysilanes (PMN 
P-08-737) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.

[[Page 61147]]

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (b)(concentration set at 0.1 percent), and 
(c). The following National Institute for Occupational Safety and 
Health (NIOSH)-certified respirators with an assigned protection factor 
(APF) of at least 10 meet the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  72l.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), (g)(l)(ii), (g)(l)(viii), and (g)(2)(iv).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(s) (100,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (f), (g), (h), 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.

0
42. Add Sec.  721.10574 to subpart E to read as follows:


Sec.  721.10574  Alkylcarboxy polyester acrylate reaction products with 
mixed metal oxides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
alkylcarboxy polyester acrylate reaction products with mixed metal 
oxides (PMN P-09-48) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section. The 
requirements of this rule do not apply to quantities of the PMN 
substance after it has been completely reacted (cured).
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), and (a)(3).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (f), (g)(1)(ii), (g)(1)(iv), 
(g)(1)(vii), (g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(4)(i), (g)(4)(iii), 
and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified Sec.  721.80 (a) (if used in the form of a powder), (b) 
(if manufactured in the form of a powder), (c) (if processed in the 
form of a powder), (k) (transport to processors using only reusable 
tote tanks cleaned not more than once per year), (y)(1), and (y)(2).
    (iv) Disposal. Requirements as specified in Sec.  721.85 (a)(1), 
(b)(1), (c)(1), and (d)(recycling of use waste stream via polymer 
reclamation as an alternative to incineration). (All incineration shall 
be via Resource Conservation and Recovery Act (RCRA) approved hazardous 
waste incineration).
    (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.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a) 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 (a)(2)(iii) of this 
section.

0
43. Add Sec.  721.10575 to subpart E to read as follows:


Sec.  721.10575  1-Propanone, 1,1'-(oxydi-4,1-phenylene)bis[2-hydroxy-
2-methyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-propanone, 1,1'-
(oxydi-4,1-phenylene)bis[2-hydroxy-2-methyl- (PMN P-09-480; CAS No. 
71868-15-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and 
(c). The following National Institute for Occupational Safety and 
Health (NIOSH)-certified respirators with an assigned protection factor 
(APF) of at least 50 satisfy the requirements of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Hazard communication program. Requirements as specified in 
Sec.  72l.72(a), (b), (c), (d), (e) (concentration set at 0.1 percent), 
(f), (g)(1)(vi), (g)(2)(ii), (g)(2)(iv), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f).
    (iv) Release to water. Requirements as specified in Sec.  721.90 
(b)(4) and (c)(4) (N=14).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (f), (g), (h), (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.

0
44. Add Sec.  721.10576 to subpart E to read as follows:


Sec.  721.10576  Polyalkenyl, N,N'-bistriazole (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyalkenyl, N,N'-bistriazole (PMN P-09-486) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 61148]]

apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
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 (a)(2)(i) of this 
section.

0
45. Add Sec.  721.10577 to subpart E to read as follows:


Sec.  721.10577  Benzenamine, 5-(1,1-dimethylethyl)-2-[(2-
ethylhexyl)thio]-,4-methylbenzenesulfonate (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 5-
(1,1-dimethylethyl)-2-[(2-ethylhexyl)thio]-,4-methylbenzenesulfonate 
(1:1) (PMN P-09-636; CAS No. 852360-51-1) is subject to reporting under 
this section for the significant new uses described in paragraph (a)(2) 
of this section. The requirements of this rule do not apply to 
quantities of the PMN substance after it has been completely reacted 
(cured).
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c), (d), (f), (g)(1)(ix), (g)(2)(ii), 
(g)(2)(iii), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (h) and (p)(15,000 kilograms, 170,000 
kilograms, and 496,000 kilograms).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(1), (b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (f), (g), (h), (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.

0
46. Add Sec.  721.10578 to subpart E to read as follows:


Sec.  721.10578  Unsaturated polyester imide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
unsaturated polyester imide (PMN P-10-231) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 52).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
47. Add Sec.  721.10579 to subpart E to read as follows:


Sec.  721.10579  Carbon black derived from the pyrolysis of rubber tire 
shreds (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as carbon 
black derived from the pyrolysis of rubber tire shreds (PMN P-10-367) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (k)(Manufacture of the PMN substance using 
only the process described in PMN; manufacturing, processing, or use of 
the PMN substance in compliance with the Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limit (PEL) for carbon black 
of 3.5 mg/m\3\; and manufacture of the PMN substance to meet the NIOSH 
recommended time weighted average (TWA) for polyaromatic hydrocarbons 
(PAH) in carbon black of 0.1 mg/m\3\); and (q).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (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 (a)(2)(i) of this 
section.

0
48. Add Sec.  721.10580 to subpart E to read as follows:


Sec.  721.10580  Poly[oxy(methyl-1,2-ethanediyl)], alpha, alpha'-[1,4-
cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)], alpha, alpha'-[1,4-
cyclohexanediylbis(methylene)]bis[omega-(2-aminomethylethoxy)- (PMN P-
10-452; CAS No. 1220986-58-2) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 98).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
49. Add Sec.  721.10581 to subpart E to read as follows:


Sec.  721.10581  Brominated polyurethane prepolymers of methylene 
diphenyl diisocyanate (MDI) (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
brominated polyurethane prepolymers of methylene diphenyl diisocyanate 
(MDI) (PMNs P-10-524 and P-10-525) are subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):

[[Page 61149]]

    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose- fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
50. Add Sec.  721.10582 to subpart E to read as follows:


Sec.  721.10582  Quaternary ammonium compound (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
quaternary ammonium compound (PMN P-10-571) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 47).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
51. Add Sec.  721.10583 to subpart E to read as follows:


Sec.  721.10583  Benzenamine, 4,4'-[1,3-phenylenebis(1-
methylethylidene)]bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzenamine, 4,4'-
[1,3-phenylenebis(1-methylethylidene)]bis- (PMN P-10-588; CAS No. 2687-
27-6) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b)(concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 1,000 meet the requirements of 
Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), 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.

0
52. Add Sec.  721.10584 to subpart E to read as follows:


Sec.  721.10584  Cyclopentene, 1,3,3,4,4,5,5-heptafluoro-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as cyclopentene, 
1,3,3,4,4,5,5-heptafluoro- (PMN P-11-29; CAS No. 1892-03-1) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (j)(dry etching agent for production 
of semiconductors), (o), and (s) (10,000 kilograms).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
53. Add Sec.  721.10585 to subpart E to read as follows:


Sec.  721.10585  Disiloxane, 1-butyl-1,1,3,3-tetramethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as disiloxane, 1-
butyl-1,1,3,3-tetramethyl- (PMN P-11-43; CAS No. 121263-51-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
54. Add Sec.  721.10586 to subpart E to read as follows:


Sec.  721.10586  Disiloxane, 1,3-dibutyl-1,1,3,3-tetramethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as disiloxane, 1,3-
dibutyl-1,1,3,3-tetramethyl- (PMN P-11-44; CAS No. 4619-08-3) is 
subject to reporting under

[[Page 61150]]

this section for the significant new uses described in paragraph (a)(2) 
of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
55. Add Sec.  721.10587 to subpart E to read as follows:


Sec.  721.10587  1H-Pyrazole, 3,4-dimethyl-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1H-pyrazole, 3,4-
dimethyl- (PMN P-11-81; CAS No. 2820-37-3) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N = 19).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
56. Add Sec.  721.10588 to subpart E to read as follows:


Sec.  721.10588  Phenol, 2-[1-[[3-(1H-imidazol-1-
yl)propyl]imino]ethyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phenol, 2-[1-[[3-
(1H-imidazol-1-yl)propyl]imino]ethyl]- (PMN P-11-98; CAS No. 1253404-
90-8) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
57. Add Sec.  721.10589 to subpart E to read as follows:


Sec.  721.10589  Unsaturated fatty acids, amides with 
polyethylenepolyamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
unsaturated fatty acids, amides with polyethylenepolyamine (PMN P-11-
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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
58. Add Sec.  721.10590 to subpart E to read as follows:


Sec.  721.10590  Fatty acids, amides with triethylentetramine 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acids, amides with triethylentetramine (PMN P-11-107) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
59. Add Sec.  721.10591 to subpart E to read as follows:


Sec.  721.10591  Tertiary ammonium compound (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
tertiary ammonium compound (PMN P-11-110) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
60. Add Sec.  721.10592 to subpart E to read as follows:


Sec.  721.10592  1-Butanol, 4-amino-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1-butanol, 4-amino- 
(PMN P-11-130; CAS No. 13325-10-5) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[[Page 61151]]


0
61. Add Sec.  721.10593 to subpart E to read as follows:


Sec.  721.10593  5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-
, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 5-
isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, 2-[(2-methyl-1-
oxo-2-propen-1-yl)oxy]ethyl ester (PMN P-11-162; CAS No. 70293-55-9) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=20).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
62. Add Sec.  721.10594 to subpart E to read as follows:


Sec.  721.10594  Hexanedioic acid, polymer with 2,2-dimethyl-1,3-
propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-
methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-
trimethylcyclohexane and 1,1'-[(1-methylethylidene)bis(4,1-
phenyleneoxy)]bis[2-propanol], iso-Bu alc.-blocked, compds. with 
triethylamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as hexanedioic acid, 
polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 
3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-
(isocyanatomethyl)-1,3,3-trimethylcyclohexane and 1,1'-[(1-
methylethylidene)bis(4,1-phenyleneoxy)]bis[2-propanol], iso-Bu alc.-
blocked, compds. with triethylamine (PMN P-11-173; CAS No. 1138156-39-
4) is subject to reporting under this section for the significant new 
uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=150) (Where primary, secondary, and 
tertiary waste treatment will occur, or treatment in a lined, self-
contained solar evaporation pond where ultraviolet light will degrade 
the substance, the number of kilograms per day per site is calculated 
after wastewater treatment).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
63. Add Sec.  721.10595 to subpart E to read as follows:


Sec.  721.10595  Octadecen-1-aminium, N-ethyl-N,N-dimethy-, ethyl 
sulfate (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as octadecen-1-
aminium, N-ethyl-N,N-dimethy-, ethyl sulfate (1:1) (PMN P-11-230; CAS 
No. 1256282-88-8) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=4).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
64. Add Sec.  721.10596 to subpart E to read as follows:


Sec.  721.10596  Oligomeric phenolic ether (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
oligomeric phenolic ether (PMN P-11-234) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
65. Add Sec.  721.10597 to subpart E to read as follows:


Sec.  721.10597  Benzeneacetonitrile, alkoxy-
[[(alkylsulfonyl)oxy]imino]- (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
benzeneacetonitrile, alkoxy-[[(alkylsulfonyl)oxy]imino]- (PMN P-11-252) 
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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
66. Add Sec.  721.10598 to subpart E to read as follows:


Sec.  721.10598  Lead strontium titanium zirconium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lead strontium 
titanium zirconium oxide (PMN P-11-270; CAS No. 61461-40-3) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.

[[Page 61152]]

    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (piezoelectric ceramics for active and 
passive underwater acoustic systems).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of 
releases for the following substances: Lead strontium titanium 
zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium 
cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 
1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; 
CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN 
P-11-274; CAS No. 56572-83-9)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (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.

0
67. Add Sec.  721.10599 to subpart E to read as follows:


Sec.  721.10599  Calcium cobalt lead titanium tungsten oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (piezoelectric ceramics for active and 
passive underwater acoustic systems).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of 
releases for the following substances: Lead strontium titanium 
zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium 
cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 
1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; 
CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN 
P-11-274; CAS No. 56572-83-9)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (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.

0
68. Add Sec.  721.10600 to subpart E to read as follows:


Sec.  721.10600  Calcium cobalt lead strontium titanium tungsten oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as calcium cobalt lead 
strontium titanium tungsten oxide (PMN P-11-272; CAS No. 1262279-30-0) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (piezoelectric ceramics for active and 
passive underwater acoustic systems).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of 
releases for the following substances: Lead strontium titanium 
zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium 
cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 
1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; 
CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN 
P-11-274; CAS No. 56572-83-9)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (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.

[[Page 61153]]


0
69. Add Sec.  721.10601 to subpart E to read as follows:


Sec.  721.10601  Lanthanum lead titanium zirconium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lanthanum lead 
titanium zirconium oxide (PMN P-11-273; CAS No. 1227908-26-0) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (piezoelectric ceramics for active and 
passive underwater acoustic systems).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of 
releases for the following substances: Lead strontium titanium 
zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium 
cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 
1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; 
CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN 
P-11-274; CAS No. 56572-83-9)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (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.

0
70. Add Sec.  721.10602 to subpart E to read as follows:


Sec.  721.10602  Lead niobium titanium zirconium oxide.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as lead niobium 
titanium zirconium oxide (PMN P-11-274; CAS No. 56572-83-9) 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)(4), (a)(6)(i), and (c). The following National Institute for 
Occupational Safety and Health (NIOSH)-certified respirators with an 
assigned protection factor (APF) of at least 50 meet the requirements 
of Sec.  721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (piezoelectric ceramics for active and 
passive underwater acoustic systems).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=8, and 8 is an aggregate of 
releases for the following substances: Lead strontium titanium 
zirconium oxide (PMN P-11-270; CAS No. 61461-40-3); Calcium cobalt lead 
titanium tungsten oxide (PMN P-11-271; CAS No. 1262279-31-1); Calcium 
cobalt lead strontium titanium tungsten oxide (PMN P-11-272; CAS No. 
1262279-30-0); Lanthanum lead titanium zirconium oxide (PMN P-11-273; 
CAS No. 1227908-26-0); and Lead niobium titanium zirconium oxide (PMN 
P-11-274; CAS No. 56572-83-9)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (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.

0
71. Add Sec.  721.10603 to subpart E to read as follows:


Sec.  721.10603  Epoxy modified alkyd resin, partially neutralized 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as epoxy 
modified alkyd resin, partially neutralized (PMN P-11-280) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (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.

0
72. Add Sec.  721.10604 to subpart E to read as follows:


Sec.  721.10604  Polyetherdiamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyetherdiamine (PMN P-11-447) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=4).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.

[[Page 61154]]

    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), 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.

0
73. Add Sec.  721.10605 to subpart E to read as follows:


Sec.  721.10605  Polyoxyalkylene ether, polymer with aliphatic 
diisocyanate, homopolymer, alkanol-blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyoxyalkylene ether, polymer with aliphatic diisocyanate, 
homopolymer, alkanol-blocked (PMN P-11-485) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o) and (s) (10,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
74. Add Sec.  721.10606 to subpart E to read as follows:


Sec.  721.10606  Alkyl substituted alkanediol polymer with aliphatic 
and alicyclic diisocyanates (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
substituted alkanediol polymer with aliphatic and alicyclic 
diisocyanates (PMN P-11-486) is subject to reporting under this section 
for the significant new uses described in paragraph (a)(2) of this 
section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o) and (s) (10,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
75. Add Sec.  721.10607 to subpart E to read as follows:


Sec.  721.10607  Aliphatic diisocyanate, homopolymer, alkanol-blocked 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic diisocyanate, homopolymer, alkanol-blocked (PMN P-11-488) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(o) and (s) (10,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
76. Add Sec.  721.10608 to subpart E to read as follows:

[[Page 61155]]

Sec.  721.10608  Aliphatic diisocyanate polymer with alkanediol and 
alkylglycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic diisocyanate polymer with alkanediol and alkylglycol (PMN P-
11-489) is subject to reporting under this section for the significant 
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(4), (a)(6)(i), (a)(6)(ii), (b) (concentration set at 0.1 
percent), and (c). The following National Institute for Occupational 
Safety and Health (NIOSH)-certified respirators with an assigned 
protection factor (APF) of at least 10 meet the requirements of Sec.  
721.63(a)(4):
    (A) NIOSH-certified air-purifying, tight-fitting half-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (B) NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N100 (if oil aerosols absent), R100, or P100 
filters.
    (C) NIOSH-certified powered air-purifying respirator equipped with 
a loose-fitting hood or helmet and high efficiency particulate air 
(HEPA) filters.
    (D) NIOSH-certified powered air-purifying respirator equipped with 
a tight-fitting facepiece (either half-face or full-face) and HEPA 
filters.
    (E) NIOSH-certified supplied-air respirator operated in pressure 
demand or continuous flow mode and equipped with a hood or helmet, or 
tight-fitting facepiece (either half-face or full-face).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o) and (s) (10,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
77. Add Sec.  721.10609 to subpart E to read as follows:


Sec.  721.10609  Imidodicarbonic diamide, N,N'-dibutyl-N',2-bis[4-[(4-
isocyanatophenyl)methyl]phenyl]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as imidodicarbonic 
diamide, N,N'-dibutyl-N',2-bis[4-[(4-isocyanatophenyl)methyl]phenyl]-
(PMN P-11-548; CAS No. 1254743-03-7) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o) and (y)(1).
    (ii) [Reserved].
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
78. Add Sec.  721.10610 to subpart E to read as follows:


Sec.  721.10610  Toluene diisocyanate, polymers with polyalkylene 
glycol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
toluene diisocyanate, polymers with polyalkylene glycol (PMNs P-11-635 
and P-11-636) are subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (o) and (y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2012-23993 Filed 10-4-12; 8:45 am]
BILLING CODE P