
[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
[Pages 48858-48878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20039]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2012-0450; FRL-9358-1]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 25 chemical substances 
which were the subject of premanufacture notices (PMNs). Fourteen 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 25 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 October 15, 2012. For purposes of 
judicial

[[Page 48859]]

review, this rule shall be promulgated at 1 p.m. (e.s.t.) on August 29, 
2012.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before September 14, 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-2012-0450, 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. Attention: 
Docket ID Number EPA-HQ-OPPT-2012-0450. 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-
2012-0450. 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. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    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

[[Page 48860]]

accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

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

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture, import, or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

C. Applicability of General Provisions

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

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 25 
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 25 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) number (if assigned for 
non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA 
section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes 14 PMN substances (P-10-405, P-10-485, P-11-48, 
P-11-63, P-11-160, P-11-181, P-11-203, P-11-247, P-11-384, P-11-557, P-
11-646, P-12-30, P-12-31, and P-12-32) 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.  [emsp14]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.

[[Page 48861]]

    This rule also includes SNURs on 11 PMN substances (P-11-411, P-11-
412, P-11-413, P-11-414, P-12-35, P-12-87, P-12-149, P-12-167, P-12-
182, P-12-260, and P-12-275) 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-5(e) SNURs'' are 
promulgated pursuant to Sec.  [emsp14]721.170. EPA has determined that 
every activity designated as a ``significant new use'' in all non-5(e) 
SNURs issued under Sec.  [emsp14]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-10-405

    Chemical name: Perfluorinated alkylthio betaine (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: May 3, 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 surfactant 
additive for dispersive use in fire fighting foams and vapor 
suppressing foams. In addition, 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 suggesting that, under some 
conditions, the PMN substance could degrade in the environment. EPA has 
concerns that the degradation products of the PMN substance 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. 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 of this PMN substance on 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:
    1. Manufacture of the PMN substance (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substances as stated in the consent order.
    2. Manufacture of the PMN substance at an annual manufacturing and 
import volume not to exceed the confidential production volume stated 
in the consent order.
    3. Submission of certain testing prior to exceeding the two 
confidential production volume limits specified in the consent order.
    4. Disposal of manufacturing wastes by incineration.
    5. Releases to surface waters not to exceed 50 ppb for the specific 
processing and use streams identified in the consent order.
    6. Risk notification. If as a result of the test data required, 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 Material Safety Data Sheet (``MSDS''), within 
90 days.
    The SNUR designates as a ``significant new use'' the absence of 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
fate and physical/chemical property testing identified in the consent 
order would help characterize possible effects of the substances and 
their degradation products. The company has agreed not to exceed the 
first production limit without performing a modified semi-continuous 
activated sludge (SCAS) test (OPPTS Test Guideline 835.5045 or 
Organisation for Economic Co-operation and Development (OECD) Test 
Guideline 302A). The PMN submitter has also agreed not to exceed the 
second production limit without performing a hydrolysis as a function 
of pH and temperature test (OPPTS Test Guideline 835.3120 or OECD Test 
Guideline 111); a metabolism and pharmacokinetic test (OPPTS Test 
Guideline 870.7485 or OECD Test Guideline 417); a modified 1-generation 
reproduction test (OECD Test Guidelines 421 or 422) in rats or mice); 
and an avian reproduction test (OECD Test Guideline 206) in mallard 
ducks. EPA has also determined that the results of certain additional 
human health, ecotoxicity, and fate testing would help characterize the 
PMN substance. The consent order does not require submission of the 
pended testing specified in the consent order 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 PMNs 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 721.10516.

PMN Numbers P-10-485 and P-11-48

    Chemical names: P-10-485: Alkyl methacrylates, polymer with 
substituted carbomonocycle, hydroxymethyl acrylamide and 
fluorinatedalkyl acrylate (generic); P-11-48: and Diethylene glycol, 
polymer with diisocyanatoalkane, polyethylene glycol monomethyl ether- 
and fluorinatedalkanol -blocked (generic).
    CAS numbers: Not available.
    Effective date of section 5(e) consent order: January 27, 2012.
    Basis for section 5(e) consent order: The PMNs states that the 
substances will be used as open, non-dispersive textile finishes. EPA 
has concerns for the formation of potential incineration or other 
decomposition products from the PMN substances. These perfluorinated 
products may be released to the environment from incomplete 
incineration of the PMN substances at low temperatures. EPA has 
preliminary evidence, including data on some fluorinated polymers, 
suggesting that, under some conditions, the PMN substances could 
degrade in the environment. EPA has concerns that the degradation 
products of the PMN substances 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 PFOA and other

[[Page 48862]]

perfluorinated carboxylates, which include the presumed environmental 
degradant of the PMN substances. 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 
products of the PMN substances 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 these substances may 
present an unreasonable risk of injury to human health and the 
environment; 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 substances and their potential degradation products. To 
protect against these risks, the consent order requires:
    1. Monitoring of the effluent waste water stream during manufacture 
in addition to the requirements of any existing NPDES permit. Data will 
be collected on the confidential analytes specified in the consent 
order and submitted to the Agency quarterly.
    2. Manufacture of the PMN substances (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substances as stated in the consent order.
    3. Risk notification. If as a result of the test data required, 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 
these protective measures.
    Recommended testing: EPA has determined that the results of a 
modified reproduction/developmental toxicity screening test (OECD Test 
Guideline 421), an avian reproduction test (OPPTS Test Guideline 
850.2300), ready biodegradability test (OPPTS Test Guideline 835.3110), 
hydrolysis as a function of pH test (OPPTS Test Guideline 835.2110), 
and indirect photolysis screening test: Sunlight photolysis in waters 
containing dissolved humic substances (OPPTS Test Guideline 835.5270) 
would help characterize possible effects of the substances and their 
degradation products. The consent order does not require the submission 
of this testing at any specified time or production volume. However, 
the consent order's restrictions on manufacture, import, processing, 
distribution in commerce, use, and disposal of the PMN substances will 
remain in effect until the consent order is modified or revoked by EPA 
based on submission of that or other relevant information.
    CFR citations: 40 CFR 721.10517 (P-10-485) and 40 CFR 721.10518 (P-
11-98).

PMN Number P-11-63

    Chemical name: Perfluoroalkyl acrylate copolymer (generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: February 23, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
substance will be used as a coating material for uses in textiles and/
or paper. EPA has concerns that the PMN substance under some conditions 
of use could cause lung effects, based on limited data on some 
perfluorinated compounds. In addition, 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 the 
degradation products of the PMN substance 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 PFOA and other perfluorinated carboxylates, 
which include the presumed environmental degradant of the PMN 
substance. 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 of the PMN substance on 
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:
    1. Manufacture of the PMN substances (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substances as stated in the consent order.
    2. No use of the PMN substance in consumer products with spray 
applications.
    3. Submission of certain fate testing prior to exceeding the 
confidential production volume limit specified in the consent order.
    4. Risk notification. If as a result of the test data required, 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 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
fate testing specified in the consent order would help characterize 
possible effects of the substance and its degradation products. The PMN 
submitter has agreed not to exceed the confidential production volume 
limit without performing the following tests which are further 
specified in the consent order: a combined direct and indirect 
photolysis with hydrolysis study, a highly modified inherent 
biodegradability: Zahn-Wellens/EMPA test (OECD Test Guideline 302B), 
accelerated weathering for textiles with a water component test, and an 
aerobic and anaerobic transformation in soil test (OECD Test Guideline 
307). The consent order does not require submission of the pended 
testing described in the consent order 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 PMNs will remain in effect until the consent order is

[[Page 48863]]

modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10519.

PMN Number P-11-160

    Chemical name: Acetylated fatty acid glycerides (generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: February 27, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a resin. 
Based on ecological structure activity relationship (EcoSAR) analysis 
of test data on analogous esters, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 3 ppb for the PMN in 
surface waters. The consent order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this 
substance may present an unreasonable risk of injury to the 
environment. To protect against this risk, the order requires use of 
the substance only as described in the order, and submission of certain 
ecotoxicity testing prior to exceeding the confidential production 
volume limit specified in the order. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance. The 
PMN submitter has agreed not to exceed the confidential production 
volume limit specified in the order without performing these tests.
    CFR citation: 40 CFR 721.10520.

PMN Number P-11-181

    Chemical name: Fluorosurfactant (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: February 17, 
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 surfactant 
for laboratory use fluid. Based on structure activity relationship 
(SAR) analysis of test data on analogous high molecular weight 
polymers, EPA identified concerns for lung toxicity for the PMN 
substance if respirable droplets are inhaled. In addition, based on SAR 
analysis of analogous substances, including PFOA and perfluorooctane 
sulfonate (PFOS), EPA identified concerns for liver toxicity, acute 
toxicity, developmental and reproductive toxicity, and cancer, when the 
mean moles of each perfluoro propylene oxide (PPO) unit is less than 5. 
Further, EPA expected the PMN substance and the perfluoro degradation 
products to be highly persistent, and the low molecular weight fraction 
is expected to be mobile and bioaccumulate in the environment. Although 
there are no ecological concerns for the PMN substance itself, there is 
high concern for possible environmental effects to mammals and wild 
birds from the perfluoro degradation products of the PMN substance. 
These concerns are based on data on analog chemicals, including PFOA 
and other perfluorinated carboxylates, which include the presumed 
environmental degradant of the PMN substance. 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 
of the PMN substance 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 
this exposure and risk, the consent order requires:
    1. Manufacture of the PMN substance (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting to EPA the average number molecular weight at each 
manufacturing facility at the time of initial commencement and annually 
thereafter, and (b) where the mean number of moles of each PPO unit 
must be greater than or equal to 5.
    2. Manufacture of the PMN substance at an annual manufacturing and 
import volume not to exceed the confidential production volume limit 
stated in the consent order.
    3. Risk notification. If as a result of the test data required, 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 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
health, fate, and physical/chemical property testing identified in the 
consent order would help characterize possible effects of the 
substances and their degradation products. The consent order does not 
require submission of the 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 721.10521.

PMN Number P-11-203

    Chemical name: Perfluoroalkylethyl methacrylate copolymer with 
dialkylaminoethylmethacrylate (generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 13, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
substance will be used as a paper treatment. 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 PFOA and other perfluorinated carboxylates, which 
include the presumed environmental degradant of the PMN substance. 
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

[[Page 48864]]

presumed degradation product of the PMN substance 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 submission of certain fate testing prior to September 30, 
2014, and risk notification. If as a result of the test data required, 
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 these protective measures.
    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 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 (OPPTS Test Guideline 835.3120 
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-
2012-0450), 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 that the results of certain health 
testing identified in the consent order would help characterize 
possible effects of the substances and their degradation products. The 
consent order does not require submission of the 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 721.10522.

PMN Number P-11-247

    Chemical name: Perfluoroalkylethyl methacrylate copolymer with 
hydroxymethyl acrylamide, vinyl chloride and long chain fatty alkyl 
acrylate (generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 13, 2012.
    Basis for section 5(e) consent order: The PMN states that the PMN 
substance will be used as a treatment for textiles. 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 PFOA and other perfluorinated carboxylates, 
which include the presumed environmental degradant of the PMN 
substance. 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 of the PMN substance on 
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 submission of certain fate testing prior to March 31, 2015, 
and risk notification. If as a result of the test data required, 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 these protective measures.
    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 March 31, 2015 without performing a modified 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 (OPPTS Test Guideline 835.3120 
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-
2012-0450), 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 that the results of certain health 
testing identified in the consent order would help characterize 
possible effects of the substances and their degradation products. The 
consent order does not require submission of the testing at any 
specified time or production volume. However, the consent order's 
restrictions on manufacture, import, processing, distribution in 
commerce, use, and

[[Page 48865]]

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 721.10523.

PMN Number P-11-384

    Chemical name: Fluorinated alkylsulfonamidol urethane polymer 
(generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: January 18, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a protective 
treatment. Based on EPA analysis of the potential content of the 
polymer, EPA is concerned that some perfluorinated substances could be 
present and if degraded, could be released into the environment. EPA 
has concerns that the PMN substance and its degradation products will 
persist in the environment, could bioaccumulate or biomagnify, and 
could be toxic to various species. These concerns are based on data on 
analog chemicals, including PFOS and other perfluorinated carboxylates, 
such as the presumed ultimate perfluorinated degradant of the PMN 
substance, perfluorobutanesulfonic acid (PFBS). Although some data 
indicate a different and less toxic toxicological and ecological 
profile for PFBS than for PFOS and PFOA, EPA believes that, based on 
the persistence of PFBS, potential intermediate fate products, and the 
fact that these products may be major substitutes for some uses of 
PFOS, more information is warranted on the fate and physical/chemical 
properties of PFBS-derived polymers in the environment. 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 the environment, the 
substance may be produced in substantial quantities, and there may be 
significant (or substantial) human exposure to the substance and its 
potential degradation products. To protect against this risk, the order 
requires submission of certain abiotic fate testing prior to exceeding 
an aggregate manufacturing and import volume of 150,000 kilograms and 
submission of certain biotic fate testing prior to exceeding an 
aggregate manufacturing and import volume of 550,000 kilograms. The 
SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Recommended testing: EPA has determined that the results of certain 
fate testing identified in the consent order would help characterize 
possible effects of the substances and their degradation products. The 
PMN submitter has agreed not to exceed the first production volume 
limit without performing a highly modified indirect photolysis 
screening test, and not to exceed the second production volume limit 
without performing a highly modified aerobic activated sludge 
biodegradation test and a modified aerobic and anaerobic transformation 
in sludge-amended to soil test. These tests are further detailed in the 
consent order. EPA has determined that the results of certain health 
and environmental effects testing identified in the consent order would 
help characterize possible effects of the substances and their 
degradation products. The consent order does not require submission of 
the 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 721.10524.

PMN Numbers P-11-411, P-11-412, P-11-413 and P-11-414

    Chemical names: Alkoxy dialkyl aminoalkanol carboxylate (generic).
    CAS numbers: Not available.
    Basis for action: The PMN states that the generic (non 
confidential) use of the substances is for contained use in energy 
production. Based on EcoSAR analysis of test data on analogous cationic 
surfactants, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 17 ppb of the PMN substances in surface 
waters. As described in the consolidated PMN, releases to surface 
waters are not expected to exceed 17 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substances may present an unreasonable risk. EPA has determined, 
however, that any use of the substances resulting in surface water 
concentrations exceeding 17 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substances 
meet the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10525.

PMN Number P-11-557

    Chemical name: 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, 
telomers with C18-26-alkyl acrylate, 1-dodecanethiol, N-
(hydroxymethyl)-2-methyl-2-propenamide, polyfluorooctyl methacrylate 
and vinylidene chloride, 2,2'-[1,2-diazenediylbis(1-
methylethylidene)bis[4,5-dihydro-1H-imidazole] hydrochloride (1:2)-
initiated (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: March 22, 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. Based on SAR analysis of test data on analogous high 
molecular weight polymers, EPA identified concerns for lung effects 
through lung overload if respirable particles of the intact PMN 
substances are inhaled. In addition, 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 PFOA and other perfluorinated carboxylates, which 
include the presumed environmental degradant of the PMN substance. 
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

[[Page 48866]]

substance may be produced in substantial quantities and may reasonably 
be anticipated to enter the environment in substantial quantities, and 
there may be significant (or substantial) human exposure to the 
substance and its potential degradation products. To protect against 
these risks, the consent order requires:
    1. Manufacture of the PMN substance (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA and (b) 
within the maximum established limits of certain fluorinated impurities 
of the PMN substances as stated in the consent order.
    2. Manufacture of the PMN substance at an annual manufacturing and 
import volume not to exceed the confidential production volume stated 
in the consent order.
    3. No use of the PMN substance in consumer products with spray 
applications.
    4. Risk notification. If as a result of the test data required, 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 
these protective measures.
    Recommended testing: EPA has determined that the results of certain 
health and environmental effects, fate, and physical/chemical property 
testing identified in the consent order would help characterize 
possible effects of the substances and their degradation products. The 
consent order does not require submission of the 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 PMNs 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 721.10526.

PMN Number P-11-646

    Chemical name: Perfluoroalkylethyl methacrylate copolymer 
(generic).
    CAS number: Not available.
    Effective date of section 5(e) consent order: March 23, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
substance will be used as a fabric treatment. EPA identified 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 PFOA and other perfluorinated carboxylates, 
which include the presumed environmental degradant of the PMN 
substance. 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 of the PMN substance 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 submission of certain fate testing prior to March 31, 2015, 
and risk notification. If as a result of the test data required, 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 these protective measures.
    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 March 31, 2015 without performing a modified 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 (OPPTS Test Guideline 835.3120 
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-
2012-0450), 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). EPA has also determined that the 
results of certain additional human health and environmental effects 
testing would help characterize the PMN substance. The consent order 
does not require submission of the pended testing specified in the 
consent order 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 PMNs 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 721.10527.

PMN Numbers P-12-30, P-12-31, and P-12-32

    Chemical names: Modified fluorinated acrylates (generic).
    CAS numbers: Not available.
    Effective date of section 5(e) consent order: April 18, 2012.
    Basis for section 5(e) consent order: The PMN states that the 
substances will be used as an open, non-dispersive textile finish. EPA 
has concerns for the formation of potential incineration or other 
decomposition products from the PMN substances. These perfluorinated 
products may be released to the environment from incomplete 
incineration of the PMN substances at low temperatures. EPA has 
preliminary evidence, including data on some fluorinated polymers, 
suggesting that, under some conditions, the PMN substances could 
degrade in the environment. EPA has concerns that these degradation 
products will persist

[[Page 48867]]

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 PFOA and other perfluorinated 
carboxylates, which include the presumed environmental degradant of the 
PMN substances. 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 these substances may present an unreasonable risk of 
injury to human health and the environment, the substances 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 substances and their 
potential degradation products. To protect against these risks, the 
consent order requires:
    1. Monitoring of the effluent waste water stream during manufacture 
in addition to the requirements of any existing NPDES permit. Data will 
be collected on the confidential analytes specified in the consent 
order and submitted to the Agency quarterly.
    2. Manufacture of the PMN substances (a) according to the chemical 
composition section of the consent order, including analyzing and 
reporting certain starting raw material impurities to EPA, and (b) 
within the maximum established levels of certain fluorinated impurities 
of the PMN substances as stated in the consent order.
    2. Risk notification. If as a result of the test data required, 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 
these protective measures.
    Recommended testing: EPA has determined that the results of an 
aerobic and anaerobic transformation in soil test (OECD Test Guideline 
307), fish short-term reproduction test (OPPTS Test Guideline 
890.1350), ready biodegradability test (OPPTS Test Guideline 835.3110), 
hydrolysis as a function of pH test (OPPTS Test Guideline 835.2110), 
and indirect photolysis screening test: sunlight photolysis in waters 
containing dissolved humic substances (OPPTS Test Guideline 835.5270) 
would help characterize possible effects of the substance and its 
degradation products. The consent order does not require the submission 
of this testing at any specified time or production volume. However, 
the consent order's restrictions on manufacture, import, processing, 
distribution in commerce, use, and disposal of the PMNs 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 721.10528.

PMN Number P-12-35

    Chemical name: Cobalt iron manganese oxide, carboxylic acid-
modified (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a ferrite dispersion ink additive to ensure magnetic performance 
characteristics. Based on test data on analogous respirable, poorly 
soluble particulates (subcategory: lithium manganese oxide), EPA 
identified concerns for lung effects to workers exposed to the PMN 
substance. EPA also identified concerns for mutagenicity based on the 
amount of cobalt and manganese in the PMN substance and neurotoxicity 
for manganese. For the uses described in the PMN, significant exposures 
to workers or the general population is unlikely. 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 following may cause serious health effects:
    1. Domestic manufacture.
    2. Use of the substance other than as described in the PMN.
    3. Use in a consumer product.
    4. Processing or use of the substance in a solid form.
    5. Manufacturing, processing, or use of the PMN substance without 
an appropriate material safety data sheet that warns to not release to 
water.
    6. Any use of the substance resulting in surface water release.
    Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465) with 60-
day holding period; workplace exposure monitoring; characterization of 
the mobility of the particles in soil using a modified version of the 
leaching test (OPPTS Test Guideline 835.1240) and/or an adsorption/
desorption (batch equilibrium) test (OPPTS Test Guideline 835.1230); a 
ready biodegradability (OECD Test Guideline 301) to characterize the 
persistence of the functional groups; and physical-chemical 
characterization data including particle size distribution by count, 
surface area, morphology, shape, and size; aggregation and 
agglomeration states using transmission electron microscopy, scanning-
transmission and electron microscopy atomic force microscopy, porosity 
using mercury intrusion, surface chemistry including elemental 
composition using electron-energy loss spectroscopy, X-ray 
photoelectron spectroscopy, auger electron spectroscopy, or atomic 
force microscopy; surface charge using zetasizer, water solubility 
(OECD Test Guideline 105), and density of liquids and solids (OECD Test 
Guideline 109) would help characterize the health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10529.

PMN Number P-12-87

    Chemical name: Acrylate manufacture byproduct distillation residue 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the uses of the substance are 
as a viscosity modifier/flow enhancer for crude oil and in boiler fuels 
as a burn promoter for fuel value. Based on test data on the PMN 
substance, and EcoSAR analysis of test data on analogous acrylates, 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 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute

[[Page 48868]]

toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); and 
an algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10530.

PMN Number P-12-149

    Chemical name: Distillation bottoms from manufacture of brominated 
cycloalkanes (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for destructive use in 
bromine recovery. Based on EcoSAR analysis of test data on analogous 
neutral organic chemicals, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 2 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 2 
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 2 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guidelines 850.1400); a 
daphnid chronic toxicity study (OPPTS Test Guidelines 850.1300); and an 
algal toxicity test (OCSPP Test Guideline 850.4500) would help 
characterize the environmental effects of the PMN substance. When 
testing the PMN substance, if difficulty is encountered in dissolving 
the chemical in the test media, consult the special consideration for 
conducting aquatic laboratory studies (OPPTS Test Guideline 850.1000).
    CFR citation: 40 CFR 721.10531.

PMN Number P-12-167

    Chemical name: Tar, brown coal.
    CAS number: 101316-83-0.
    Basis for action: The PMN states that the substance will be used 
for blending existing tar oil with petroleum oil for feed to 
refineries. EPA has identified health and environmental concerns 
because the substance may be a persistent, bio-accumulative, and toxic 
(PBT) chemical, based on physical/chemical properties of the PMN 
substance, as described in the New Chemical Program's PBT category (64 
FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the PMN 
substance will persist in the environment more than two months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Also, based on SAR analysis of test data on analogous polycyclic 
aromatic hydrocarbons, EPA identified concerns for irritation and 
possible corrosion to all exposed tissues, solvent neurotoxicity, liver 
and kidney toxicity, effects to the pancreas and spleen, 
photosensitization, and oncogenicity. These concerns are for workers 
exposed via inhalation or dermal contact with the PMN substance. 
Additionally, based on EcoSAR analysis of test data on analogous 
neutral organic chemicals, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 ppb of the PMN substance in 
surface waters. For the uses described in the PMN, significant 
exposures to workers or the general population is unlikely and the 
substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk to the human health or the 
environment. EPA has determined, however, that any predictable or 
purposeful release containing the PMN substance into the waters of the 
United States 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), 
(b)(4)(ii), and (b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
aerobic and anaerobic transformation in aquatic sediment systems test 
(OECD Test Guideline 308) and the bioconcentration: flow-through fish 
test (OECD Test Guideline 305) would help characterize the persistent 
and bioaccumulative attributes of the PMN substance. In addition, the 
results of a fish early-life stage toxicity test (OPPTS Test Guideline 
850.1400); a daphnid chronic toxicity test (OPPTS Test Guideline 
850.1300); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
would help characterize the environmental effects of the PMN substance. 
When testing the PMN substance, if difficulty is encountered in 
dissolving the chemical in the test media, consult the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000).
    CFR citation: 40 CFR 721.10532.

PMN Number P-12-182

    Chemical name: Amine-modified urea-formaldehyde polymer (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a mining chemical. Based 
on EcoSAR analysis of test data on analogous polycationic polymers, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 56 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 56 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 56 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity mitigated by humic acid test (OPPTS Test Guidelines 
850.1085); a fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010); and an algal 
toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10533.

PMN Number P-12-260

    Chemical name: Brominated aliphatic alcohol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be for destructive use. Based 
on EcoSAR analysis of test data on analogous halo-alcohols, 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

[[Page 48869]]

PMN substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance. EPA also recommends that 
the special considerations for conducting aquatic laboratory studies 
(OPPTS Test Guideline 850.1000) be followed.
    CFR citation: 40 CFR 721.10534.

PMN Number P-12-275

    Chemical name: Phosphonium, tributyltetradecyl-, chloride (1:1).
    CAS number: 81741-28-8.
    Basis for action: The PMN states that the substance will be used as 
reactant for the production of proprietary chemicals in the electronics 
industry. EPA has identified environmental concerns because the 
substance may be a PBT chemical, based on physical/chemical properties 
of the PMN substance, as described in the New Chemical Program's PBT 
category. EPA estimates that the PMN substance will persist in the 
environment more than two months and estimates a bioaccumulation factor 
of greater than or equal to 1,000. Additionally, based on EcoSAR 
analysis of test data on analogous cationic surfactants, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
11 ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any predictable or purposeful release containing the PMN 
substance into the waters of the United States may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii) and 
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
aerobic and anaerobic transformation in aquatic sediment systems test 
(OECD Test Guideline 308) and the bioconcentration: Flow-through fish 
test (OECD Test Guideline 305) would help characterize the persistent 
and bioaccumulative attributes of the PMN substance. In addition, EPA 
has determined that the results of a fish early-life stage toxicity 
test (OPPTS Test Guideline 850.1400); a daphnid chronic toxicity test 
(OPPTS Test Guideline 850.1300); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize environmental effects of 
the PMN substance. When testing the PMN substance, if difficulty is 
encountered in dissolving the chemical in the test media, consult the 
special considerations for conducting aquatic laboratory studies (OPPTS 
Test Guideline 850.1000).
    CFR citation: 40 CFR 721.10535.

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 14 of the 25 
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.  [emsp14]721.160 (see Unit 
II.).
    In the other 11 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.  [emsp14]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 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.  [emsp14]721.160(c)(3) and Sec.  [emsp14]721.170(d)(4). In 
accordance with Sec.  [emsp14]721.160(c)(3)(ii) and Sec.  
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is October 
15, 2012 without further notice, unless EPA receives written adverse or 
critical comments, or notice of intent to submit adverse or critical 
comments before September 14, 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 September 14, 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 August 15, 2012.
    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. TSCA section 5(e) consent orders have 
been issued for 14 chemical substances and the PMN

[[Page 48870]]

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, 23 of the 
25 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.  [emsp14]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 notice 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 
notice 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.  [emsp14]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 test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines'' or for guidelines that are not 
currently available on the Web site, EPA has placed a copy of that 
guideline in the public docket. The 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.
    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 
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 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,

[[Page 48871]]

manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  [emsp14]721.1725(b)(1) with 
that under Sec.  [emsp14]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.  [emsp14]721.1(c), persons submitting a SNUN must 
comply with the same notice requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described in 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.  [emsp14]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-
2012-0450.

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

    According to the Paperwork Reduction Act (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

    On February 18, 2012, EPA certified pursuant to section 605(b) of 
the Regulatory Flexibility Act (RFA) (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 SNUN submitted by any small entity would not cost 
significantly more than $8300. 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 $8300.

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

    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 sections 202, 203, 
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 
104-4).

E. Executive Order 13132

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

F. Executive Order 13175

    This rule does not have Tribal implications because it is not 
expected to have substantial direct effects on

[[Page 48872]]

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

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, 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).

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 rule 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: August 9, 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. The table in Sec.  [emsp14]9.1 is amended by adding the following 
sections in numerical order under the undesignated center heading 
``Significant New Uses of Chemical Substances'' to read as follows:


Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
Significant New Uses of Chemical
Substances
 
                                * * * * *
721.10516...............................................       2070-0012
721.10517...............................................       2070-0012
721.10518...............................................       2070-0012
721.10519...............................................       2070-0012
721.10520...............................................       2070-0012
721.10521...............................................       2070-0012
721.10522...............................................       2070-0012
721.10523...............................................       2070-0012
721.10524...............................................       2070-0012
721.10525...............................................       2070-0012
721.10526...............................................       2070-0012
721.10527...............................................       2070-0012
721.10528...............................................       2070-0012
721.10529...............................................       2070-0012
721.10530...............................................       2070-0012
721.10531...............................................       2070-0012
721.10532...............................................       2070-0012
721.10533...............................................       2070-0012
721.10534...............................................       2070-0012
721.10535...............................................       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.  721.10516 to subpart E to read as follows:


Sec.  721.10516  Perfluorinated alkylthio betaine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluorinated alkylthio betaine (PMN P-10-405) 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 company becomes aware that 
this substance may present a risk of injury to human health, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.

[[Page 48873]]

    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (analysis, reporting, and limitation of 
maximum impurity levels of certain fluorinated impurities as described 
in the chemical composition section of the consent order), (q), and 
(t).
    (iii) Disposal. Requirements as specified in Sec.  721.85(a)(1).
    (iv) Release to water. Requirements as specified in Sec.  
721.90(b)(4) and (c)(4) (N=50 for the specific release waste streams 
specified in the consent order).
    (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), (i), (j), 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 paragraphs (a)(2)(ii) 
and (iv) of this section.

0
5. Add Sec.  721.10517 to subpart E to read as follows:


Sec.  721.10517  Alkyl methacrylates, polymer with substituted 
carbomonocycle, hydroxymethyl acrylamide and fluorinatedalkyl acrylate 
(generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
methacrylates, polymer with substituted carbomonocycle, hydroxymethyl 
acrylamide and fluorinatedalkyl acrylate (PMN P-10-485) is subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (Monitoring of the effluent waste water 
stream during manufacture in addition to any existing NPDES permit. 
Monitoring data will be collected on the confidential analytes and 
submitted to the Agency quarterly. Analysis, reporting, and limitation 
of maximum impurity levels of certain fluorinated impurities.).
    (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), 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)(ii) of 
this section.

0
6. Add Sec.  721.10518 to subpart E to read as follows:


Sec.  721.10518  Diethylene glycol, polymer with diisocyanatoalkane, 
polyethylene glycol monomethyl ether- and fluorinatedalkanol-blocked 
(generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diethylene glycol, polymer with diisocyanatoalkane, polyethylene glycol 
monomethyl ether- and fluorinatedalkanol-blocked (PMN P-11-48) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (Monitoring of the effluent waste water 
stream during manufacture in addition to any existing NPDES permit. 
Monitoring data will be collected on the confidential analytes and 
submitted to the Agency quarterly. Analysis, reporting, and limitation 
of maximum impurity levels of certain fluorinated impurities.).
    (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), 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)(ii) of 
this section.

0
7. Add Sec.  721.10519 to subpart E to read as follows:


Sec.  721.10519  Perfluoroalkyl acrylate copolymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkyl acrylate copolymer (PMN P-11-63) is subject to reporting 
under this section for the

[[Page 48874]]

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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (analysis and reporting and limitations 
of maximum impurity levels of certain fluorinated impurities), (o)(use 
in a consumer product that could be spray applied), and (q).
    (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), 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)(ii) of 
this section.

0
8. Add Sec.  721.10520 to subpart E to read as follows:


Sec.  721.10520  Acetylated fatty acid glycerides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
acetylated fatty acid glycerides (PMN P-11-160) is subject to reporting 
under this section for the significant new uses described in paragraph 
(a)(2) of this section. The requirements of this rule do not apply to 
quantities of the PMN substance after it has been completely reacted 
(cured) or entrained in a film.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) and (q).
    (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
9. Add Sec.  721.10521 to subpart E to read as follows:


Sec.  721.10521  Fluorosurfactant (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
fluorosurfactant (PMN P-11-181) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture of the PMN substance 
according to the chemical composition section of the consent order, 
including analyzing and reporting to EPA the average number molecular 
weight at each manufacturing facility at the time of initial 
commencement and annually thereafter, and where the mean number of 
moles of each PPO unit must be greater than or equal to 5) and (t).
    (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), 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)(ii) of 
this section.


0
10. Add Sec.  721.10522 to subpart E to read as follows:


Sec.  721.10522  Perfluoroalkylethyl methacrylate copolymer with 
dialkylaminoethylmethacrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkylethyl methacrylate copolymer with 
dialkylaminoethylmethacrylate (PMN P-11-203) 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, the 
employer must

[[Page 48875]]

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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the 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), 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)(ii) of 
this section.


0
11. Add Sec.  721.10523 to subpart E to read as follows:


Sec.  721.10523  Perfluoroalkylethyl methacrylate copolymer with 
hydroxymethyl acrylamide, vinyl chloride and long chain fatty alkyl 
acrylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
perfluoroalkylethyl methacrylate copolymer with hydroxymethyl 
acrylamide, vinyl chloride and long chain fatty alkyl acrylate (PMN P-
11-247) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (any amount after March 31, 2015).
    (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)(ii) of 
this section.

0
12. Add Sec.  721.10524 to subpart E to read as follows:


Sec.  721.10524  Fluorinated alkylsulfonamidol urethane polymer 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
fluorinated alkylsulfonamidol urethane polymer (PMN P-11-384) 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(p) (production limits set at 150,000 
kilograms and at 550,000 kilograms).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), 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.  721.10525 to subpart E to read as follows:


Sec.  721.10525  Alkoxy dialkyl aminoalkanol carboxylate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as alkoxy 
dialkyl aminoalkanol carboxylate (PMNs P-11-411, P-11-412, P-11-413 and 
P-11-414) 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) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4)(N = 17).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c) and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  721.10526 to subpart E to read as follows:


Sec.  721.10526  2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, 
telomers with C[bdi1][bdi8]-[bdi2][bdi6]-alkyl acrylate, 1-
dodecanethiol, N-(hydroxymethyl)-2-methyl-2-propenamide, 
polyfluorooctyl methacrylate and vinylidene chloride, 2,2'-[1,2-
diazenediylbis(1-methylethylidene)bis[4,5-dihydro-1H-imidazole] 
hydrochloride (1:2)-initiated (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 2-
propenoic acid, 2-methyl-, 2-hydroxyethyl ester, telomers with 
C18-26-alkyl acrylate, 1-dodecanethiol, N-(hydroxymethyl)-2-
methyl-2-propenamide, polyfluorooctyl methacrylate and vinylidene 
chloride, 2,2'-[1,2-diazenediylbis(1-methylethylidene)bis[4,5-dihydro-
1H-imidazole] hydrochloride (1:2)-initiated

[[Page 48876]]

(PMN P-11-557) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (Manufacture of the PMN substance 
according to the chemical composition section of the consent order, 
where the company must analyze and report certain starting raw material 
impurities, and within the maximum established levels of certain 
fluorinated impurities of the PMN substances), (j) (use in a consumer 
product that could be spray applied), and (t).
    (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), 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)(ii) of 
this section.

0
15. Add Sec.  721.10527 to subpart E to read as follows:


Sec.  721.10527  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-11-646) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(p) (any amount after March 31, 2015).
    (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), 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)(ii) of 
this section.

0
16. Add Sec.  721.10528 to subpart E to read as follows:


Sec.  721.10528  Modified fluorinated acrylates (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
modified fluorinated acrylates (PMNs P-12-30, P-12-31, and P-12-32) 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) 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, 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 this 
substance from the employer are provided a MSDS as described in Sec.  
721.72(c) containing the information required under paragraph 
(a)(2)(i)(A) of this section within 90 days from the time the employer 
becomes aware of the new information.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (Monitoring of the effluent waste water 
stream during manufacture in addition to the existing NPDES permit. 
Monitoring data will be collected on the confidential analytes and 
submitted to the Agency quarterly. Analysis, reporting, and limitation 
of maximum impurity levels of certain fluorinated impurities.).
    (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), and (i) are

[[Page 48877]]

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
17. Add Sec.  721.10529 to subpart E to read as follows:


Sec.  721.10529  Cobalt iron manganese oxide, carboxylic acid-modified 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as cobalt 
iron manganese oxide, carboxylic acid-modified (PMN P-12-35) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72(c) and (g) (do not release to water).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(f), (j) (ferrite dispersion ink additive 
to ensure magnetic performance characteristics), (o), (v)(2), and 
(x)(2).
    (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), (i), and (k) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
18. Add Sec.  721.10530 to subpart E to read as follows:


Sec.  721.10530  Acrylate manufacture byproduct distillation residue 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance is identified generically as 
acrylate manufacture byproduct distillation residue (PMN P-12-87) 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
19. Add Sec.  721.10531 to subpart E to read as follows:


Sec.  721.10531  Distillation bottoms from manufacture of brominated 
cycloalkanes (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
distillation bottoms from manufacture of brominated cycloalkanes (PMN 
P-12-149) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(4), (b)(4), and (c)(4) (N =2).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (k) are applicable to manufacturers, 
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  721.10532 to subpart E to read as follows:


Sec.  721.10532  Tar, brown coal.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as tar, brown coal 
(PMN P-12-167, CAS No. 101316-83-0) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(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. Record keeping 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
21. Add Sec.  721.10533 to subpart E to read as follows:


Sec.  721.10533  Amine-modified urea-formaldehyde polymer (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as amine-
modified urea-formaldehyde polymer (PMN P-12-182) 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 = 56).
    (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
22. Add Sec.  721.10534 to subpart E to read as follows:


Sec.  721.10534  Brominated aliphatic alcohol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
brominated aliphatic alcohol (PMN P-12-260) 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.

[[Page 48878]]


0
23. Add Sec.  721.10535 to subpart E to read as follows:


Sec.  721.10535  Phosphonium, tributyltetradecyl-, chloride (1:1).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as phosphonium, 
tributyltetradecyl-, chloride (1:1) (PMN P-12-275; CAS No. 81741-28-8) 
is subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  
721.90(a)(1), (b)(1), and (c)(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. Record keeping 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.

[FR Doc. 2012-20039 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P


