Document ID: EPA-HQ-OPPT-2012-0740-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2012-11-02T04:00Z

[Federal Register Volume 77, Number 213 (Friday, November 2, 2012)]
[Rules and Regulations]
[Pages 66149-66164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26658]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0740; FRL-9366-7]
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 20 chemical substances 
which were the subject of premanufacture notices (PMNs). Eight 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 20 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 January 2, 2013. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
November 16, 2012.
    Written adverse or critical comments, or notice of intent to submit 
adverse or

[[Page 66150]]

critical comments, on one or more of these SNURs must be received on or 
before December 3, 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-2012-0740, by one of the following methods:
     Federal eRulemaking Portal: http://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-2012-0740. 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-
2012-0740. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at http://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 http://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 http://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 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.

[[Page 66151]]

    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 section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA 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 20 
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 20 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).
     Toxicity concerns.
     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 8 PMN substances 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

[[Page 66152]]

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 12 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-11-135

    Chemical name: Benzoic acid, 4-[(1-oxodecyl)oxy]-.
    CAS number: 86960-46-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a cleaning enhancer additive 
for laundry and automatic dish-washing products. Based on test data on 
the PMN substance, and ecological structural activity relationship 
(EcoSAR) analysis of test data on analogous esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
18 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 18 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 domestic 
manufacture or use of the substance other than as described in the PMN 
could result in exposures which 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 fish 
early-life stage toxicity test (Office of Pollution Prevention and 
Toxic Substances (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. Due to low water 
solubility, EPA also recommends that the special considerations for 
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000) 
be followed to facilitate solubility in the test media.
    CFR citation: 40 CFR 721.10611.

PMN Numbers P-11-327, P-11-328, P-11-329, P-11-330, P-11-331, and P-11-
332

    Chemical names: Distillates (lignocellulosic), C5-40 (P11-327); 
Paraffin waxes (lignocellulosic) hydrotreated, C5-40-branched, cyclic 
and linear (P-11-328); Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear (P-11-329); Kerosene (lignocellulosic), 
hydrotreated, C8-16-branched, cyclic and linear (P-11-330); Distillates 
(lignocellulosic), hydrotreated, C8-26-branched, cyclic, and linear (P-
11-331); and Residual oils (lignocellulosic), hydrotreated, C20-40- 
branched, cyclic, and linear (P-11-332).
    CAS numbers: 1267611-99-3 (P-11-327), 1267611-06-2 (P-11-328), 
1267611-35-7 (P-11-329), 1267611-14-2 (P-11-330), 1267611-11-9 (P-11-
331), and 1267611-71-1 (P-11-332).
    Effective date of TSCA section 5(e) consent order: July 21, 2012.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) uses of the PMN substances will be as a 
distillation feedstock after hydrotreatment (P-11-327), as a feedstock 
(P-11-328), as a blend-stock for conventional fossil fuels (P-11-329, 
P-11-330, and P-11-331) and use in a manner comparable to gas oil as it 
is currently used in industry (P-11-332). These PMNs are complex 
mixtures and have been assessed based on the toxic components within 
their mixture. The most important and primary component present is 
benzene. Based on this analysis, EPA identified concerns for 
oncogenicity, immunosuppression, and skin sensitization (defatting of 
the skin tissue) to workers exposed to the PMN substances. The EPA 
Maximum Contaminant Level for benzene in drinking water is 5 ppb. The 
PMNs' new chemical exposure limit (NCEL) is 0.32 milligram/cubic meter 
(mg/m\3\) as an 8-hour time-weighted average. In addition, based on 
EcoSAR analysis of test data on analogous neutral organics, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 82 ppb for P-11-329 and P-11-331, and 180 ppb for P-11-327, P-
11-328, P-11-330, and P-11-332. However, EPA does not expect risk to 
aquatic organisms at the expected levels and duration of exposure as 
described in the PMNs. 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 these 
substances 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 personal protective equipment including dermal protection 
when there is potential dermal exposure and a National Institute for 
Occupational Safety and Health (NIOSH)-certified respirator with an 
assigned protection factor (APF) of at least 10,000, or compliance with 
a NCEL of 0.32 mg/m\3\ as an 8-hour time-weighted average when there is 
potential inhalation exposure.
    2. No use of the substances resulting in surface water 
concentrations exceeding 5 ppb of the combination of these PMN 
substances.
    3. Establishment and use of a hazard communication program.

The SNUR designates as a ``significant new use'' the absence of these 
protective measures.

    Recommended testing: EPA has determined that a combined chronic 
toxicity/carcinogenicity test (OPPTS Test Guideline 870.4300); a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and fish 
early-life stage toxicity test (OPPTS Test

[[Page 66153]]

Guideline 850.1400) would help characterize the human health and 
environmental effects of the PMN substances. The Order does not require 
submission of the testing at any specified time or production volume. 
However, the order's restrictions on manufacture, import, processing, 
distribution in commerce, use, and disposal will remain in effect until 
the order is modified or revoked by EPA based on submission of that or 
other relevant information.
    CFR citations: 40 CFR 721.10612 (P-11-237); 721.10613 (P-11-328); 
721.10614 (P-11-329); 721.10615 (P-11-330); 721.10616 (P-11-331); and 
721.10617 (P-11-332).

PMN Number P-11-607

    Chemical name: Polyaromatic Organophosphorus Compound (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: July 11, 2012.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an additive 
flame retardant (open, non-dispersive use). Based on test data on the 
PMN substance itself, EPA expects the PMN substance to hydrolyze under 
neutral and basic conditions. EPA does not expect significant human 
health concerns from the intact chemical, but there is uncertainty 
regarding the hydrolysis products. Based on test data on structurally 
similar phosphinate esters and submitted algae data on the PMN 
substance itself, EPA expects toxicity to aquatic organisms to occur at 
concentrations that exceed 6 ppb. 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 findings that uncontrolled manufacture, import, processing, 
distribution in commerce, use, and disposal of the PMN substance may 
present an unreasonable risk of injury to the environment, the 
substance may be produced in substantial quantities, 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 the substance only as described in the PMN.
    2. Establishment and use of a hazard communication program.
    3. No use of the substance that results in releases to surface 
water.
    Recommended testing: EPA has determined that certain testing would 
help characterize the fate, environmental and human health effects of 
the PMN substance. The consent order contains two production limits. 
The PMN submitter has agreed not to exceed the first production volume 
limit without performing: A daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300); fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); a washing machine study at basic pH based on the 
International Organization for Standardization (ISO) color fastness 
test to ascertain release rates with analytics to identify hydrolysis 
products (ISO 105); an inherent biodegradability test (OPPTS Test 
Guideline 835.3215); and a hydrolysis as a function of pH and 
temperature test (OPPTS Test Guideline 835.2130). If the results of the 
first tier of testing demonstrate that the PMN substance may cause 
adverse effects to humans or the environment, the PMN submitter has 
agreed to not exceed a production limit before conducting additional 
testing to ascertain whether those releases from representative end-use 
articles are in sufficient quantities to pose a significant risk.
    EPA has also determined that a prenatal developmental toxicity 
study (OPPTS Test Guideline 870.3700 or OECD 414) using oral (gavage) 
in the rat would help characterize the human health effects of the PMN 
substance. The order does not require the submission of the prenatal 
developmental toxicity study at any specified time or production 
volume. However, the 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 721.10618.

PMN Number P-11-653

    Chemical name: Perfluoroalkylethyl methacrylate copolymer 
(generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: July 12, 2012.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a water and 
oil repellant. EPA has concerns for the formation of potential 
incineration or other decomposition products from the PMN substance. 
These perfluorinated products may be released to the environment from 
incomplete incineration of the PMN substance at low temperatures. EPA 
has preliminary evidence, including data on some fluorinated polymers, 
suggesting that, under some conditions, the PMN substance could degrade 
in the environment. EPA has concerns that these degradation products 
will persist in the environment, could bioaccumulate or biomagnify, and 
could be toxic to people, wild mammals, and birds. These concerns are 
based on data on analog chemicals, including perfluorooctanoic acid 
(PFOA) and other perfluorinated carboxylates, such as the presumed 
environmental degradant of the PMN substance, perfluorohexanoic acid 
(PFHxA). There is pharmacokinetic and toxicological data in animals on 
PFOA, as well as epidemiological and blood monitoring data in humans. 
Toxicity studies on PFOA indicate developmental, reproductive, and 
systemic toxicity in various species, as well as cancer. These factors, 
taken together, raise concerns for potential adverse chronic effects 
from the presumed degradation product in humans and wildlife. 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 risk notification. If the Company becomes aware that the PMN 
substance may present a risk of injury to human health or the 
environment, the Company must incorporate this new information, and any 
information on methods for protecting against such risk into a MSDS, 
within 90 days. The SNUR designates as a ``significant new use'' the 
absence of this protective measure.
    Recommended testing: EPA has determined that the results of certain 
fate testing identified in the consent order would help characterize 
possible effects of the substance and its degradation products. The PMN 
submitter has agreed not to manufacture or import the PMN substance 
after September 30, 2014, without performing a modified semi-continuous 
activated sludge (SCAS) test (OPPTS Test Guideline 835.5045 or OECD 
Test Guideline 302A); a UV/visible absorption test (OPPTS Test 
Guideline 830.7050); direct photolysis rate in water by sunlight test 
(OPPTS Test Guideline 835.2210); a hydrolysis as a function of pH and 
temperature test

[[Page 66154]]

(OPPTS Test Guideline 835.2130 or OECD Test Guideline 111); an indirect 
photolysis screening test: sunlight photolysis in waters containing 
dissolved humic substances (OPPTS Test Guideline 835.5270); a 
photolysis on soils study using the phototransformation of chemicals on 
soil surfaces OECD Test Guideline 2005 Draft (located in the docket 
under docket ID number EPA-HQ-OPPT-2012-0740); aerobic and anaerobic 
transformation in aquatic sediment systems (OECD Test Guideline 308); 
and an anaerobic biodegradability of organic compounds in digested 
sludge by measurement of gas production test (OECD Test Guideline 311). 
These tests are further detailed in the consent order. EPA has 
determined if the substance was to be sprayed by commercial or consumer 
applicants, that the results of a 90-day inhalation toxicity test 
(OPPTS Test Guideline 870.3465) in rats with a 60-day holding period 
would help characterize possible effects of the substance and its 
degradation products. The consent order does not require submission of 
the inhalation 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 721.10619.

PMN Number P-12-191

    Chemical name: Oxirane, 2,2'-(phenylene)bis-.
    CAS number: 30424-08-9.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a component of adhesives and 
composites. Based on structural activity relationship (SAR) of test 
data on analogous epoxides, EPA identified developmental and male 
reproductive toxicity and cancer concerns to workers exposed to the PMN 
substance via the inhalation route. In addition, based on EcoSAR 
analysis of test data on analogous epoxides, 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, significant 
inhalation exposures are not expected due to low vapor pressure when 
the substance is distributed with less than or equal to 5 percent 
impurities, and releases of the 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 may present an unreasonable risk. EPA has determined, 
however, that any distribution of the substance with greater than 5 
percent impurities, or any use of the substance resulting in surface 
water concentrations exceeding 10 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 ready 
biodegradability test (OPPTS Test Guideline 835.3110); a combined 
repeated-dose toxicity study with the reproduction/developmental 
toxicity screening test (OECD Test Guideline 422) via the inhalation 
route in rats; a carcinogenicity study (OECD Test Guideline 451); 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 721.10620.

PMN Number P-12-196

    Chemical name: Distillation bottoms, alkylated benzene by-product 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non 
confidential) use of the substance is for bromine recovery. Based on 
test data on the PMN substance and EcoSAR analysis of test data on 
analogous neutral organics, 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 
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 (Office of Chemical Safety and Pollution Prevention 
(OCSPP) Test Guidelines 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 to facilitate solubility in 
the test media, because of the PMN's low water solubility.
    CFR citation: 40 CFR 721.10621.

PMN Number P-12-285

    Chemical name: Copper(2+), tetraammine-, chloride (1:2).
    CAS number: 10534-87-9.
    Basis for action: The PMN states that the generic (non 
confidential) uses of the substance are as a raw material for 
production of copper chemicals and as a raw material for the production 
of animal feed micronutrients. Based on test data on the PMN substance 
and EcoSAR analysis of test data on analogous inorganic copper 
complexes, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 3 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 3 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 3 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 fish 
BCF Test (OPPTS Test Guideline 850.1730) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10622.

PMN Numbers P-12-298 and P-12-299

    Chemical name: Vinylidene ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
an adhesive. Based on EcoSAR analysis of test data on analogous esters, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 7 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

[[Page 66155]]

exceed releases from the use described in the PMN. For the use 
described in the PMN, environmental releases did not exceed 7 ppb for 
more than 20 days per year. if releases of the PMN substances to 
surface water from uses other than described in the PMN exceed the 
releases expected from the use described in the PMN. For the described 
use in the PMN, significant environmental releases 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 combined production volume of the two 
PMN substances exceeding 20,000 kilograms per year could result in 
exposures which may cause significant adverse environmental effects. 
Based on this information, the PMN substances 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 Guidelines 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guidelines 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10623.

PMN Number P-12-326

    Chemical name: Dicyclohexylmethane-4,4'-diisocyanate, polymer with 
ethoxylated, propoxylated polyethers (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as part of 2-component 
reactive polyurethane adhesive resin. Based on analogous diisocyanate 
substances, EPA identified concerns for potential dermal and 
respiratory sensitization from dermal and inhalation exposures, and for 
pulmonary toxicity from inhalation exposure to the PMN substance. 
Specifically, the Agency expects potential toxicity to workers from 
dermal or inhalation exposure to the PMN substance when the molecular 
weight is less than 1000 daltons. For the uses described in the PMN and 
due to the use of personal protective equipment, significant worker 
exposure to the PMN substance where the molecular weight is less than 
1000 daltons is unlikely, as dermal and inhalation 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 the manufacture, 
processing, or use of the substance where the molecular weight is less 
than 1000 daltons 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 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) and a skin 
sensitization test (OPPTS Test Guideline 870.2600) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10624.

PMN Numbers P-12-332 and P-12-333

    Chemical name: Distillation bottoms, alkylated benzene by-product, 
brominated and bromo diphenyl alkane.
    CAS number: Not available.
    Basis for action: The PMNs state that the PMN substances will be 
used as a feed for a bromine recovery unit. Based on test data on 
analogous chemical substances, the Agency identified concerns for liver 
toxicity and the potential for other human health risks due to the 
possible formation of dioxins and furans. These concerns are for 
workers exposed to the PMN substances by the inhalation and dermal 
routes. For the uses described in the PMNs and due to the use of 
personal protective equipment, significant worker exposure is unlikely, 
as dermal and inhalation exposure is not expected. 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 use of the substances other than as described in the PMNs 
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 90-
day oral toxicity in rodents test (OPPTS Test Guideline 870.3100) and 
either a determination of polychlorinated dibenzo-p-dioxins and 
polychlorinated dibenzofurans from stationary sources study (EPA Method 
23); or a polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated 
dibenzofurans (PCDFs) by high resolution gas chromatography/high 
resolution mass spectrometry (HRGC/HRMS) study (EPA Method 8290A); or a 
same-sample determination of ultratrace levels of 
polybromodiphenylethers, polybromodibenzo-p-dioxins/furans, and 
polychlorodibenzo-p-dioxins/furans from combustion flue gas study 
(Wyrzykowska, B., Tabor, D., and Gullett, B. Anal. Chem., 2009, 81 
(11), 4334-4342.) on each of the PMN substances would help characterize 
the human health effects of the PMN substances.
    CFR citation: 40 CFR 721.10625.

PMN Number P-12-373

    Chemical name: 1,4-Butanediol, polymer with substituted alkane and 
substituted methylene biscarbomonocycle, 2-hydroxyalkyl acrylate-
blocked (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an abrasion resistant, 
formable dual-cure lacquer for screen printing. Based on test data on 
analogous acrylates and isocyanates, EPA identified concerns for 
respiratory and dermal sensitization and irritation to workers from 
exposure to the PMN substance. Additionally, the Agency identified low 
to moderate concern for mutagenicity, oncogenicity, and developmental 
toxicity for the low molecular weight acrylates. 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 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. For the uses described in the PMN and due 
to the use of personal protective equipment, significant worker 
exposure is unlikely, as dermal and inhalation 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 use of the 
substance in consumer products or in spray applications 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 a 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465) and a skin sensitization 
test (OPPTS Test Guideline 870.2600) would help characterize the human 
health effects of the PMN substance.
    CFR citation: 40 CFR 721.10626.

[[Page 66156]]

PMN Number P-12-430

    Chemical name: Yttrium borate phosphate vanadate with europium and 
additional dopants (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a coating for the 
interior surface of glass lamps. Based on test data on analogous 
chemical substances, EPA identified health concerns for lung effects if 
the poorly soluble, respirable particles are inhaled. Additionally, due 
to the crystalline structure of the PMN substance, the Agency 
identified concern for oncogenicity if the PMN substance was inhaled. 
These concerns are for workers exposed to the PMN substance by 
inhalation. For the use described in the PMN and at the production 
volume stated in the PMN, significant worker inhalation 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 use of the PMN 
substance other than as described in the PMN or use exceeding the 
annual manufacture or import volume stated in the PMN may result in 
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 a 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465) would help characterize 
the health effects of the PMN substance.
    CFR citation: 40 CFR 721.10627.

PMN Number P-12-432

    Chemical name: Mixed metal oxalate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an intermediate 
precipitate used to produce phosphors. Based on test data on analogous 
chemical substances, EPA identified health concerns for lung effects if 
the poorly soluble, respirable particles are inhaled. Additionally, due 
to the crystalline structure of the PMN substance, the Agency 
identified concern for oncogenicity if the PMN substance was inhaled. 
These concerns are for workers exposed to the PMN substance by 
inhalation. For the use described in the PMN and at the production 
volume stated in the PMN, significant worker inhalation 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 use of the PMN 
substance other than as described in the PMN or use exceeding the 
annual manufacture or import volume stated in the PMN may result in 
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 a 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465) would help characterize 
the health effects of the PMN substance.
    CFR citation: 40 CFR 721.10628.

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 8 of the 20 
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 12 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 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

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 January 2, 2013 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before December 3, 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 December 3, 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.
    This rule establishes SNURs for a number of 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, November 2, 2012.
    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances

[[Page 66157]]

subject to this rule have undergone premanufacture review. TSCA section 
5(e) consent orders have been issued for 8 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, 11 of the 
20 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 April 24, 1990 SNUR, 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-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 and OPPTS test guidelines 
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines'' or for 
guidelines not currently available on the Web site, EPA has placed a 
copy of that guideline in the public docket. The Organization for 
Economic Co-operation and Development (OECD) test guidelines are 
available from the OECD Bookshop at http://www.oecdbookshop.org or 
SourceOECD at http://www.sourceoecd.org. To access EPA Method 23 and 
Method 8290A, please go to http://www.epa.gov/ttn/emc/methods/method23.html and http://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/8290a.pdf. To access the International Organization for Standardization 
(ISO) standard, ISO 105, please go to http://www.ihs.com/products/industry-standards/org/iso/list/page9.aspx.
    In the TSCA section 5(e) consent orders for several 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 study 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 
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

[[Page 66158]]

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 http://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-
2012-0740.

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 (RAF)

    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 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

[[Page 66159]]

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)

    This action does not involve any technical standards, so 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: October 22, 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 sections 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.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
 
                                * * * * *
               Significant New Uses of Chemical Substances
 
                                * * * * *
721.10611...........................................           2070-0012
721.10612...........................................           2070-0012
721.10613...........................................           2070-0012
721.10614...........................................           2070-0012
721.10615...........................................           2070-0012
721.10616...........................................           2070-0012
721.10617...........................................           2070-0012
721.10618...........................................           2070-0012
721.10619...........................................           2070-0012
721.10620...........................................           2070-0012
721.10621...........................................           2070-0012
721.10622...........................................           2070-0012
721.10623...........................................           2070-0012
721.10624...........................................           2070-0012
721.10625...........................................           2070-0012
721.10626...........................................           2070-0012
721.10627...........................................           2070-0012
721.10628...........................................           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.  721.10611 to subpart E to read as follows:

Sec.  721.10611  Benzoic acid, 4-[(1-oxodecyl)oxy]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as benzoic acid, 4-
[(1-oxodecyl)oxy]- (PMN P-11-135, CAS No. 86960-46-5) 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(f) and (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 this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
5. Add Sec.  721.10612 to subpart E to read as follows:

Sec.  721.10612  Distillates (lignocellulosic), C5-40.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as distillates 
(lignocellulosic), C5-40 (PMN P-11-327, CAS No. 1267611-99-3) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.

[[Page 66160]]

    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b)(concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10613 to subpart E to read as follows:

Sec.  721.10613  Paraffin waxes (lignocellulosic) hydrotreated, C5-40--
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2) 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)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10614 to subpart E to read as follows:

Sec.  721.10614  Naphtha (lignocellulosic), hydrotreated, C5-12-
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as naphtha 
(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (PMN 
P-11-329, CAS No. 1267611-35-7) 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)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to

[[Page 66161]]

those contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10615 to subpart E to read as follows:

Sec.  721.10615  Kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as kerosene 
(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (PMN 
P-11-330, CAS No. 1267611-14-2) 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)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10616 to subpart E to read as follows:

Sec.  721.10616  Distillates (lignocellulosic), hydrotreated, C8-26--
branched, cyclic, and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as distillates 
(lignocellulosic), hydrotreated, C8-26--branched, cyclic, and linear 
(PMN P-11-331, CAS No. 1267611-11-9) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and

[[Page 66162]]

residual oils (lignocellulosic), hydrotreated, C20-40- branched, 
cyclic, and linear (PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10617 to subpart E to read as follows:

Sec.  721.10617  Residual oils (lignocellulosic), hydrotreated, C20-40- 
branched, cyclic, and linear.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1) 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)(3), (a)(4), (a)(6), (b) (concentration set at 0.1 
percent), and (c). The following NIOSH-approved respirators with an APF 
of 10,000 meet the minimum requirements for Sec.  721.63(a)(4): Any 
NIOSH-certified pressure-demand or other positive pressure mode (e.g., 
open/closed circuit) self-contained breathing apparatus (SCBA) equipped 
with a hood or helmet or a full facepiece.
    (A) As an alternative to the respiratory requirements listed in 
paragraph (a)(2)(i), 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 
0.32 milligram/cubic meter (mg/m\3\) as an 8-hour time-weighted 
average. Persons who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. Persons whose Sec.  721.30 requests to use the NCELs approach 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding section 5(e) consent order.
    (B) [Reserved]
    (ii) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c), (d), (e)(concentration set at 0.1 percent), 
(f), and (g).
    (iii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (Where N=5, and 5 is an aggregate of 
releases for the following substances: distillates (lignocellulosic), 
C5-40 (PMN P-11-327, CAS No. 1267611-99-3); paraffin waxes 
(lignocellulosic) hydrotreated, C5-40--branched, cyclic and linear (PMN 
P-11-328, CAS No. 1267611-06-2); naphtha (lignocellulosic), 
hydrotreated, C5-12-branched, cyclic and linear (PMN P-11-329, CAS No. 
1267611-35-7); kerosene (lignocellulosic), hydrotreated, C8-16-
branched, cyclic and linear (PMN P-11-330, CAS No. 1267611-14-2); 
distillates (lignocellulosic), hydrotreated, C8-26--branched, cyclic, 
and linear (PMN P-11-331, CAS No. 1267611-11-9); and residual oils 
(lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 
(PMN P-11-332, CAS No. 1267611-71-1)).
    (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 (h) 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.  721.10618 to subpart E to read as follows:

Sec.  721.10618  Polyaromatic organophosphorus compound (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
polyaromatic organophosphorus compound (PMN P-11-607) 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 embedded in 
a solid polymer matrix.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72(a), (b), (c). (d), (e), (f), (g)(3)(i), (g)(3)(ii), and 
(g)(4)(iii).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) and (q).
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
12. Add Sec.  721.10619 to subpart E to read as follows:

Sec.  721.10619  Perfluoroalkylethyl methacrylate copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkylethyl methacrylate copolymer (PMN P-11-653) 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) Hazard communication program. A significant new use of this 
substance is any manner or method of manufacture, import, or processing 
associated with any use of this substance without providing risk 
notification as follows:
    (A) If as a result of the test data required under the TSCA section 
5(e) consent order for this substance, the employer becomes aware that 
this substance may present a risk of injury to human health or the 
environment, the employer must incorporate this new information, and 
any information on methods for protecting against such risk, into a 
Material Safety Data Sheet (MSDS) as described in Sec.  721.72(c) 
within 90 days from the time the employer becomes aware of the new 
information. If this substance is not being manufactured, imported, 
processed, or used in the employer's workplace, the employer must add 
the new information to a MSDS before the substance is reintroduced into 
the workplace.
    (B) The employer must ensure that persons who will receive the PMN 
substance from the employer, or who have received the PMN substance 
from the employer within 5 years from the date the employer becomes 
aware of the new information described in paragraph (a)(2)(i)(A) of 
this section, are provided an MSDS containing the information required 
under paragraph (a)(2)(i)(A) within 90 days from the time the

[[Page 66163]]

employer becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p)(any amount after September 30, 2014).
    (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), (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
13. Add Sec.  721.10620 to subpart E to read as follows:

Sec.  721.10620  Oxirane, 2,2'-(phenylene)bis-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as oxirane, 2,2'-
(phenylene)bis- (PMN P-12-191, CAS No. 30424-08-9) 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) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j)(distribution of chemical substance with 
less than or equal to 5 percent impurities).
    (ii) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N= 10).
    (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 significant new use rule.

0
14. Add Sec.  721.10621 to subpart E to read as follows:

Sec.  721.10621  Distillation bottoms, alkylated benzene by-product 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
distillation bottoms, alkylated benzene by-product (PMN P-12-196) 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.  721.10622 to subpart E to read as follows:

Sec.  721.10622  Copper(2+), tetraammine-, chloride (1:2).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as copper(2+), 
tetraammine-, chloride (1:2) (PMN P-12-285, CAS No. 10534-87-9) 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= 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 (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
16. Add Sec.  721.10623 to subpart E to read as follows:

Sec.  721.10623  Vinylidene ester (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
vinylidene ester (PMNs P-12-298 and P-12-299) 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(s)(20,000 kilograms of the aggregate of 
the two chemical substances).
    (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
17. Add Sec.  721.10624 to subpart E to read as follows:

Sec.  721.10624  Dicyclohexylmethane-4,4'-diisocyanate, polymer with 
ethoxylated, propoxylated polyethers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dicyclohexylmethane-4,4'-diisocyanate, polymer with ethoxylated, 
propoxylated polyethers (PMN P-12-326) 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, processing, or use where 
the molecular weight is 1000 daltons or more).
    (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.  721.10625 to subpart E to read as follows:

Sec.  721.10625  Distillation bottoms, alkylated benzene by-product, 
brominated and bromo diphenyl alkane (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
distillation bottoms, alkylated benzene by-product, brominated and 
bromo diphenyl alkane (PMNs P-12-332 and P-12-333) 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)(feed for a bromine recovery unit).
    (ii) [Reserved]

[[Page 66164]]

    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
19. Add Sec.  721.10626 to subpart E to read as follows:

Sec.  721.10626  1,4-Butanediol, polymer with substituted alkane and 
substituted methylene biscarbomonocycle, 2-hydroxyalkyl acrylate-
blocked (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 1,4-
butanediol, polymer with substituted alkane and substituted methylene 
biscarbomonocycle, 2-hydroxyalkyl acrylate-blocked (PMN P-12-373) 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
20. Add Sec.  721.10627 to subpart E to read as follows:

Sec.  721.10627  Yttrium borate phosphate vanadate with europium and 
additional dopants (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as yttrium 
borate phosphate vanadate with europium and additional dopants (PMN P-
12-430) 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) and (s).
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
21. Add Sec.  721.10628 to subpart E to read as follows:

Sec.  721.10628  Mixed metal oxalate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as mixed 
metal oxalate (PMN P-12-432) 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) and (s).
    (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.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[FR Doc. 2012-26658 Filed 11-1-12; 8:45 am]
BILLING CODE 6560-50-P