Proposed Significant New Use Rules on Certain Chemical Substances, 81447-81462 [2011-33261]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 249 (Wednesday, December 28, 2011)]
[Proposed Rules]
[Pages 81447-81462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33261]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2010-0279; FRL-9326-2]
RIN 2070-AB27


Proposed Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 17 
chemical substances which were the subject of premanufacture notices 
(PMNs). Fifteen of these chemical substances are subject to TSCA 
section 5(e) consent orders issued by EPA. This action would require 
persons who intend to manufacture, import, or process any of these 17 
chemical substances for an activity that is designated as a significant 
new use by this proposed rule to notify EPA at least 90 days before 
commencing that activity. The required notification would provide EPA 
with the opportunity to evaluate the intended use and, if necessary, to 
prohibit or limit that activity before it occurs.

DATES: Comments must be received on or before January 27, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2010-0279, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line 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-2010-0279. 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-
2010-0279. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://

[[Page 81448]]

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this 
proposed 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; 
see also 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 a final SNUR 
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 a proposed or final SNUR are 
subject to the export notification provisions of TSCA section 12(b) (15 
U.S.C. 2611(b)) (see Sec.  [emsp14]721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    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?

    These proposed SNURs would, when finalized, require persons to 
notify EPA at least 90 days before commencing the manufacture, import, 
or processing of the specific chemical substances identified in the 
PMNs for any activity

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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 of April 24, 1990 (55 FR 17376). 
Consult that preamble for further information on the objectives, 
rationale, and procedures for SNURs and on the basis for significant 
new use designations, including provisions for developing test data.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the TSCA section 5(a)(2) factors, listed in 
Unit III. of this document. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
and 40 CFR part 721 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.  [emsp14]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 final 
rule. Provisions relating to user fees appear at 40 CFR part 700.
    According to Sec.  [emsp14]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 section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the 
regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take 
regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the 
activities for which it has received the SNUN. If EPA does not take 
action, EPA is required under TSCA section 5(g) to explain in the 
Federal Register its reasons for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 17 
chemical substances that are the subject of these proposed SNURs, EPA 
considered relevant information about the toxicity of the chemical 
substances, likely human exposures and environmental releases 
associated with possible uses, taking into consideration the four 
bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to this Proposed Rule

    EPA is proposing to establish significant new use and recordkeeping 
requirements for 17 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).
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this proposed rule.
    This proposed rule includes 7 PMN substances whose reported 
chemical names include the term ``carbon nanotube'' or ``CNT''. Because 
of a lack of established nomenclature for carbon nanotubes, the TSCA 
Inventory names for carbon nanotubes are currently in generic form, 
e.g., carbon nanotube (CNT), multi-walled carbon nanotube (MWCNT), 
double-walled carbon nanotube (DWCNT), or single-walled carbon nanotube 
(SWCNT). EPA uses the specific structural characteristics provided by 
the PMN submitter to more specifically characterize the Inventory 
listing for an individual CNT. All submitters of new chemical notices 
for CNTs have claimed those specific structural characteristics as CBI. 
EPA is publishing the generic chemical name along with the PMN number 
to identify that a distinct chemical substance was the subject of the 
PMN without revealing the confidential chemical identity of the PMN 
substance. Confidentiality claims preclude a more detailed description 
of the identity of these CNTs. If an intended manufacturer, importer, 
or processor of CNTs is unsure of whether its CNTs are subject to this 
proposed SNUR or any other SNUR, the company can either contact EPA or 
obtain a written determination from EPA pursuant to the bona fide 
procedures at Sec.  721.11. EPA is using the specific structural 
characteristics, for all CNTs submitted as new chemical substances 
under TSCA, to help develop standard nomenclature for placing these 
chemical substances on the TSCA Inventory. EPA has compiled a generic 
list of those structural characteristics entitled ``Material 
Characterization of Carbon Nanotubes for Molecular Identity (MI) 
Determination & Nomenclature.'' A copy of this list is available in the 
docket for these proposed SNURs under docket ID number EPA-HQ-OPPT-
2010-0279. If EPA develops a more specific generic chemical name for 
these materials, that name will be made publicly available.
    The regulatory text section of this proposed rule specifies the 
activities designated as significant new uses. Certain new uses, 
including exceeding production volume limits (i.e., limits on 
manufacture and importation volume) and other uses designated in this 
rule, may be claimed as CBI.
    This proposed rule includes 15 PMN substances for which EPA 
determined, pursuant to TSCA section 5(e), that uncontrolled 
manufacture, import, processing, distribution in commerce, use, and 
disposal may present an unreasonable risk of injury to human health or 
the environment. Accordingly, these substances are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I). Those 
consent

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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 proposed pursuant to Sec.  14;721.160, and 
are based on and consistent with the provisions in the underlying 
consent orders. The 5(e) SNURs designate as a ``significant new use'' 
the absence of the protective measures required in the corresponding 
consent orders.
    Where EPA has determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions exist in 40 CFR 
part 721, subpart B, for SNURs. Therefore, for these cases, the 
individual SNURs in 40 CFR part 721, subpart E, will state that persons 
subject to the SNUR who wish to pursue NCELs as an alternative to the 
Sec.  721.63 respirator requirements may request to do so under Sec.  
721.30. EPA expects that persons whose Sec.  721.30 requests to use the 
NCELs approach for SNURs are approved by EPA will be required to comply 
with NCELs provisions that are comparable to those contained in the 
corresponding TSCA section 5(e) consent order for the same chemical 
substance.
    This proposed rule also includes SNURs on 2 PMN substances that are 
not subject to a consent order 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 met the criteria set forth under TSCA section 
5(e). However, EPA does believe that certain changes from the use 
scenario described in these PMNs could result in increased exposures, 
and therefore should be designated a significant new use. These so-
called ``non-5(e) SNURs'' are being proposed 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-04-244

    Chemical name: Ethane, 2-bromo-1, 1-difluoro-.
    CAS number: 359-07-9.
    Effective date of the TSCA section 5(e) consent order: February 16, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
the substance will be used as a chemical intermediate for an herbicide. 
The order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that this substance may present an 
unreasonable risk of injury to human health. To protect against this 
risk, the consent order: (1) Requires use of personal protective 
equipment including impervious gloves and a National Institute for 
Occupational Safety and Health (NIOSH)-certified supplied-air 
respirator operated in pressure demand or other positive pressure mode 
and equipped with a tight-fitting full facepiece with an assigned 
protection factor (APF) of at least 75, or compliance with a NCEL of 
0.5 mg/m\3\ as an 8-hour time-weighted average; (2) requires 
establishment of a hazard communication program; (3) prohibits use of 
the PMN substance other than as a chemical intermediate for an 
herbicide; and (4) requires corresponding recordkeeping. The proposed 
SNUR would designate as a ``significant new use'' the absence of these 
protective measures.
    Toxicity concern: Based on test data on analogous structurally 
similar alkyl halides, EPA identified health concerns for systemic 
toxicity, developmental toxicity, reproductive toxicity, and cancer in 
workers exposed to the PMN substance by the inhalation route.
    Recommended testing: EPA has determined that a carcinogenicity test 
(OPPTS Test Guideline 870.4200) in rats by the inhalation route would 
help characterize the human health effects of the PMN substance. The 
PMN submitter has agreed not to exceed a particular production volume 
limit without performing this test.
    CFR citation: 40 CFR 721.10265.

PMN Numbers P-08-733 and P-08-734

    Chemical names: Multi-walled carbon nanotubes (generic) (P-08-733 
and P-08-734).
    CAS numbers: Not available.
    Effective date of the TSCA section 5(e) consent order: July 26, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMNs state that 
the generic (non-confidential) uses of the substances will be as: 
Reinforcement for composites, conductive additive for composites, and 
conductive additive for batteries. The order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that 
these substances may present an unreasonable risk of injury to human 
health or the environment. To protect against these risks, the consent 
order: (1) Requires use of personal protective equipment including 
gloves and chemical protective clothing, and a NIOSH-certified air-
purifying, tight-fitting full-face respirator equipped with N-100, P-
100, or R-100 filter with an APF of at least 50; (2) prohibits the 
domestic manufacture of the PMN substances; (3) restricts use of the 
PMN substances to those uses specified in the consent order; prohibits 
the release of the PMN substances into the waters of the United States; 
and (4) requires corresponding recordkeeping. The proposed SNUR would 
designate as a ``significant new use'' the absence of these protective 
measures.
    Toxicity concern: Based on test data for analogous chemicals, 
including other carbon nanotubes, there are concerns for pulmonary 
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity 
of the PMN substances. Based on test data on respirable, poorly soluble 
particulates, EPA has concerns for lung effects. There are also data 
suggesting that pulmonary deposition of some nanoscale materials, 
including carbon nanotubes in the agglomerated form, may induce 
cardiovascular toxicity when these nanoscale materials are inhaled. The 
major health concerns are for potential pulmonary toxicity, fibrosis, 
and cancer to workers exposed via inhalation. Sublethal effects have 
been noted for some carbon nanoscale substances in fish at levels as 
low as 100 parts per billion (ppb). Further, studies need to be 
conducted before EPA can determine a concentration of concern. Such 
studies must measure actual concentrations of carbon nanotubes and 
control for the effects of contaminants, solvents, and physical factors 
such as blockage of gills or intestines.

[[Page 81451]]

    Recommended testing: EPA has determined that the following tests 
would help characterize possible effects of the substances. The PMN 
submitter has agreed not to exceed a specified production limit without 
performing these tests on one of the PMN substances: A 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465 or Organisation 
for Economic Co-operation and Development (OECD) Test Guideline 413) 
with a post-exposure observation period of up to 3 months, 
bronchoalveolar lavage fluid (BALF) analysis, a determination of 
cardiovascular toxicity (clinically-based blood/plasma protein 
analyses), and histopathology of the heart and certain material 
characterization data.
    CFR citation: 40 CFR 721.10266.

PMN Numbers P-09-54, P-09-55, P-09-56, and P-09-57

    Chemical names: (P-09-54) [5,6]Fullerene-C60-Ih; (P-09-55) 
[5,6]Fullerene-C70-D5h(6); (P-09-56) [5,6]Fullerene-C84-D2; and (P-09-
57) [5,6]Fullerene-C84-D2d.
    CAS numbers: (P-09-54) 99685-96-8; (P-09-55) 115383-22-7; (P-09-56) 
145809-19-4; and (P-09-57) 145809-20-7.
    Effective date of the TSCA section 5(e) consent order: August 16, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
uses of the substances will be as: An intermediate compound for use in 
producing downstream products that will in turn be used in organic 
electronic devices and an additive to improve mechanical properties or 
conductivity; a compound used to improve the mechanical properties of 
rubbers, plastics, and lubricants; and a compound for use as an 
additive to increase the conductivity of materials. The order was 
issued under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on 
a finding that these substances may present an unreasonable risk of 
injury to human health. To protect against this risk, the consent 
order: (1) Requires use of personal protective equipment including 
gloves and protective clothing impervious to the chemical substances 
and a NIOSH-certified full-face respirator with N-100 cartridges; (2) 
restricts use of the PMN substances to those uses specified in the 
consent order; (3) prohibits release of the PMN substances into the 
waters of the United States; and (4) requires corresponding 
recordkeeping. The proposed SNUR would designate as a ``significant new 
use'' the absence of these protective measures.
    Toxicity concern: Based on test data on poorly soluble 
particulates, including some carbon-based nano-sized chemicals, and 
test data correlating lung irritation to particle size, EPA has 
concerns for lung effects from inhalation exposure.
    Recommended testing: EPA has determined that the following tests 
would help characterize possible effects of the substances. The PMN 
submitter has agreed not to exceed a particular production limit 
without performing these tests on all of the PMN substances: Dry 
particle size distribution by count for each PMN substance in a form 
which has the highest content of particles smaller than 10 microns as 
manufactured, processed, or used in the workplace at sites controlled 
by the PMN submitter (the method shall be scanning transmission 
electron microscopy, using a dry particle counting method, with a 
resolution of less than 1 nanometer and with no counting after 
dispersion in a solution and evaporating solvent) and dustiness (EN 
15051 method).
    EPA has determined that the results of the following tests would 
help characterize the human health effects of the PMN substance. The 
order does not require the submission of the following information at 
any specified time or production volume: 90-day inhalation toxicity 
(OPPTS Test Guideline 870.3465 or OECD Test Guideline 413); dispersion 
and solubility in fresh water without the use of dispersants or 
solvents (Refs. 1 and 2). However, the order's restrictions on 
manufacture, import, processing, distribution in commerce, use, and 
disposal of the PMN substance will remain in effect until the order is 
modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citations: 40 CFR 721.10267 (P-09-54); 40 CFR 721.10268 (P-09-
55); 40 CFR 721.10269 (P-09-56); and 40 CFR 721.10270 (P-09-57).

PMN Numbers P-09-142, P-09-143, P-09-144, and P-09-416

    Chemical names: (P-09-142 and Chemical A in P-09-416) 3'-H-
cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, 
methyl ester; (P-09-143 and Chemical B in P-09-416) 3'H-
cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, 
methyl ester; and (P-09-144 and Chemical C in P-09-416) 3'H-
cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, 
methyl ester.
    CAS numbers: (P-09-142 and Chemical A in P-09-416) 160848-22-6; (P-
09-143 and Chemical B in P-09-416) 609771-63-3; and (P-09-144 and 
Chemical C in P-09-416) 1051371-21-1.
    Effective date of the TSCA section 5(e) consent orders: (P-09-142, 
P-09-143, and P-09-144) November 1, 2010 and (P-09-416) October 28, 
2010.
    Basis for the TSCA section 5(e) consent orders: The PMNs state that 
the uses of the substances will be: As a compound used in fabrication 
and/or operation of electronic devices that enables or improves the 
conductivity, efficiency, voltage, or other characteristics of the 
device, and a compound that improves the mechanical properties of 
lubricants and plastics (P-09-142, P-09-143, and P-09-144), and as 
acceptor molecules in a polymer coating in an encapsulated organic 
photovoltaic electronic device (P-09-416). The orders were issued under 
TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding 
that these substances may present an unreasonable risk of injury to 
human health. To protect against these risks, the consent orders: (1) 
Require the use of personal protective equipment including impervious 
gloves and chemical protective clothing and use of a NIOSH-certified 
air-purifying tight-fitting full-face respirator equipped with N-100 
cartridges; (2) restrict use of the PMN substances to those uses 
specified in their respective consent orders; (3) prohibit release of 
the PMN substances into the waters of the United States; and (4) 
require corresponding recordkeeping. The proposed SNUR would designate 
as a ``significant new use'' the absence of these protective measures.
    Toxicity concern: Based on test data on poorly soluble 
particulates, including some carbon-based nano-sized chemicals, and 
test data correlating lung irritation to particle size, EPA has 
concerns for lung effects from inhalation exposure.
    Recommended testing: EPA has determined that the following tests 
would help characterize the human health effects of the PMN substances. 
The consent orders each contain two production limits. The PMN 
submitters have agreed not to exceed their first production limits 
without performing a 90-day inhalation toxicity study (OPPTS Test 
Guideline 870.3465 or OECD Test Guideline 413) in rats with a post 
exposure observation period of up to 3 months, including a BALF 
analysis, a determination of cardiovascular toxicity (clinically-based 
blood/plasma protein analyses), and histopathology of the heart and 
certain material characterization data on the test material which can 
be any one of these PMN substances. The PMN submitters

[[Page 81452]]

have also agreed not to exceed the second production limits without 
providing certain physical-chemical properties on each of the PMN 
substances.
    The consent order for P-09-416 does not require the submission of 
the following information at any specified time or production volume: 
Dispersion and solubility in fresh water without the use of dispersants 
or solvents (Refs. 1 and 2) and daphnid chronic toxicity test (OPPTS 
Test Guideline 850.1300). However, the order's restrictions on 
manufacture, import, processing, distribution in commerce, use, and 
disposal of the PMN substance will remain in effect until the order is 
modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citations: 40 CFR 721.10271 (P-09-142 and Chemical A in P-09-
416); 40 CFR 721.10272 (P-09-143 and Chemical B in P-09-416); and 40 
CFR 721.10273 (P-09-144 and Chemical C in P-09-416).

PMN Number P-09-188

    Chemical name: Multi-walled carbon nanotubes (generic) (P-09-188).
    CAS number: Not available.
    Effective date of the TSCA section 5(e) consent order: December 14, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
the generic (non-confidential) use of the substance will be as an 
electric conductive filler to replace conventional material such as 
carbon black or carbon fiber in matrices such as polymer resin for 
conductive applications. The order was issued under TSCA sections 
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that this 
substance may present an unreasonable risk of injury to human health or 
the environment. To protect against these risks, the consent order: (1) 
Requires use of personal protective equipment including gloves and 
chemical protective clothing impervious to the PMN substance, and a 
NIOSH-certified air-purifying, tight-fitting full-face respirator 
equipped with N-100, P-100, or R-100 filter with an APF of at least 50; 
(2) prohibits domestic manufacture in the United States; (3) restricts 
use of the PMN substance to those uses specified in the consent order; 
(4) prohibits the manufacture, processing, or use of the PMN substance 
for commercial or consumer products, or in a consumer product; 
prohibits release of the PMN substance into the waters of the United 
States; and (5) requires corresponding recordkeeping. The proposed SNUR 
would designate as a ``significant new use'' the absence of these 
protective measures.
    Toxicity concern: Based on test data for analogous chemicals 
including other carbon nanotubes there are concerns for pulmonary 
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity 
of the PMN substance. Based on test data on respirable, poorly soluble 
particulates, EPA has concerns for lung effects. There are also data 
suggesting that pulmonary deposition of some nanoscale materials, 
including carbon nanotubes in the agglomerated form, may induce 
cardiovascular toxicity when these nanoscale materials are inhaled. The 
major health concerns are for potential pulmonary toxicity, fibrosis, 
and cancer to workers exposed via inhalation. Sublethal effects have 
been noted for some carbon nanoscale substances in fish at levels as 
low as 100 ppb. Further studies need to be conducted before EPA can 
determine a concentration of concern. Such studies must measure actual 
concentrations of carbon nanotubes and control for the effects of 
contaminants, solvents, and physical factors such as blockage of gills 
or intestines.
    Recommended testing: EPA has determined that the following tests 
would help characterize possible effects of the PMN substance. The PMN 
submitter has agreed not to exceed two production volume limits 
specified in the order without performing these tests: A 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test 
Guideline 413) with a post-exposure observation period of up to 3 
months, a BALF analysis, determination of cardiovascular toxicity, 
heart histopathology, data on pulmonary deposition, and certain 
material characterization and physical-chemical properties on the test 
material(s).
    The order does not require the submission at any specified time or 
production volume of the following exposure data on representative 
forms of the PMN substance: Release of the PMN substance after landfill 
disposal (EPA Method 1320), release of the PMN substance during burning 
(American Society for Testing and Materials International (ASTM) E1354-
09), release of the PMN substance after exposure to sunlight (ASTM 
D2565-99 (2008)), and release of the PMN substance during shipping and 
use. However, the order's restrictions on manufacture, import, 
processing, distribution in commerce, use, and disposal of the PMN 
substance will remain in effect until the order is modified or revoked 
by EPA based on submission of that or other relevant information. The 
company may propose alternative methods, guidelines, or representative 
sets subject to EPA's approval.
    CFR citation: 40 CFR 721.10274.

PMN Number P-09-417

    Chemical name: Multi-walled carbon nanotubes (generic) (P-09-417).
    CAS number: Not available.
    Effective date of the TSCA section 5(e) consent order: March 23, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
the use of the substance will be as a plastics additive to improve 
electrical, thermal, and/or mechanical properties. The order was issued 
under TSCA sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a 
finding that this substance may present an unreasonable risk of injury 
to human health or the environment. To protect against these risks, the 
consent order: (1) Requires use of personal protective equipment 
including gloves and protective clothing impervious to the chemical 
substance and NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N-100, P-100, or R-100 filter with an APF of 
50; (2) prohibits the domestic manufacture of the PMN substance; (3) 
restricts use of the PMN substance to the uses specified in the consent 
order; (4) prohibits use of the PMN substance in commercial or consumer 
products; (5) prohibits release of the PMN substance into the waters of 
the United States during processing and use activities; and (6) 
requires corresponding recordkeeping. The proposed SNUR would designate 
as a ``significant new use'' the absence of these protective measures.
    Toxicity concern: Based on test data for analogous chemicals 
including other carbon nanotubes there are concerns for pulmonary 
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity 
of the PMN substance. Based on test data on the PMN substance and 
respirable, poorly soluble particulates, EPA has concerns for lung 
effects. There are also data suggesting that pulmonary deposition of 
some nanoscale materials, including carbon nanotubes in the 
agglomerated form, may induce cardiovascular toxicity when these 
nanoscale materials are inhaled. The major health concerns are for 
potential pulmonary toxicity, fibrosis, and cancer to workers exposed 
via inhalation. Sublethal effects have been noted for some carbon 
nanoscale substances in fish at levels as low as 100 ppb. Further 
studies need to be conducted before EPA can determine a concentration 
of concern. Such studies must measure actual concentrations of carbon 
nanotubes and control for the

[[Page 81453]]

effects of contaminants, solvents, and physical factors such as 
blockage of gills or intestines.
    Recommended testing: EPA has determined that the following test 
would help characterize the possible effects of the PMN substance. The 
PMN submitter has agreed not to exceed the production limit without 
providing certain physical/chemical properties test data. The order 
does not require the submission of the following information at any 
specified time or production volume: The results of a combined chronic 
toxicity/carcinogenicity testing of respirable fibrous particles test 
(OPPTS Test Guideline 870.8355). However, the order's restrictions on 
manufacture, import, processing, distribution in commerce, use, and 
disposal of the PMN substance will remain in effect until the order is 
modified or revoked by EPA based on submission of that or other 
relevant information.
    CFR citation: 40 CFR 721.10275.

PMN Numbers P-10-39 and P-10-40

    Chemical names: Multi-walled carbon nanotubes (generic) (P-10-39) 
and single-walled and multi-walled carbon nanotubes (generic) (P-10-
40).
    CAS numbers: (P-10-39) Not available and (P-10-40) not available.
    Effective date of the TSCA section 5(e) consent order: August 30, 
2010.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
the generic (non-confidential) use of the substances will be as 
composite structures for defense, electronic, and aerospace 
applications. The order was issued under TSCA sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I) based on a finding that these substances may 
present an unreasonable risk of injury to human health or the 
environment. To protect against these risks, the consent order: (1) 
Requires use of personal protective equipment including gloves and 
protective clothing impervious to the chemical substances, and a NIOSH-
certified air-purifying, tight-fitting full-face respirator equipped 
with N-100, P-100, or R-100 filter with an APF of at least 50; (2) 
restricts use of the PMN substances to the uses specified in the 
consent order; (3) prohibits manufacture, processing, or use of the PMN 
substance for commercial or consumer products; (4) prohibits release of 
the PMN substances into the waters of the United States; and (5) 
requires corresponding recordkeeping. The proposed SNUR would designate 
as a ``significant new use'' the absence of these protective measures.
    Toxicity concern: Based on test data for analogous chemicals 
including other carbon nanotubes there are concerns for pulmonary 
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity 
of the PMN substances. Based on test data on respirable, poorly soluble 
particulates, EPA has concerns for lung effects. There are also data 
suggesting that pulmonary deposition of some nanoscale materials, 
including carbon nanotubes in the agglomerated form, may induce 
cardiovascular toxicity when these nanoscale materials are inhaled. The 
major health concerns are for potential pulmonary toxicity, fibrosis, 
and cancer to workers exposed via inhalation. Sublethal effects have 
been noted for some carbon nanoscale substances in fish at levels as 
low as 100 ppb. Further studies need to be conducted before EPA can 
determine a concentration of concern. Such studies must measure actual 
concentrations of carbon nanotubes and control for the effects of 
contaminants, solvents, and physical factors such as blockage of gills 
or intestines.
    Recommended testing: EPA has determined that the following tests 
would help characterize the possible effects of the PMN substances. The 
consent order contains three production limits. The PMN submitter has 
agreed not to exceed the first production limit without submitting 
certain material characterization data on both substances. The PMN 
submitter has agreed not to exceed the second production limit without 
performing workplace exposure monitoring and characterization testing 
(including byproducts) as well as quantification and characterization 
of substances that may be released during exposures typical during the 
use phase. The PMN submitter has also agreed not to exceed the third 
production limit without performing a 90-day inhalation toxicity test 
(OPPTS Test Guideline 870.3465 or OECD Test Guideline 413) with a post-
exposure observation period of up to 3 months, a BALF analysis, 
determination of cardiovascular toxicity, heart histopathology, data on 
pulmonary deposition, and certain material characterization and 
physical-chemical properties on either or both of the substances that 
workers may be exposed to.
    CFR citations: 40 CFR 721.10276 (P-10-39) and 40 CFR 721.10277 (P-
10-40).

PMN Number P-10-224

    Chemical name: 4,4'-Bipyridinium, 1-(phosphonoalkyl)-1'-
substituted-, salt with anion (1:2) (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a constituent in ink 
formulation. Based on test data on a salt of the anion of the PMN 
substance and analogous respirable poorly soluble particulates, EPA 
identified concerns for toxicity concerns to the liver and lung and 
neurotoxicity to workers exposed to the PMN substance. For the uses 
described in the PMN, significant worker exposure is unlikely, as 
dermal and inhalation exposure will be minimal due to adequate personal 
protective equipment and no domestic manufacture. Therefore, EPA has 
not determined that the proposed manufacturing method, processing 
method, or use of the substance may present an unreasonable risk. EPA 
has determined, however, that any use of the PMN substance: (1) Without 
the use of impervious gloves where there is potential for dermal 
exposure, (2) without the use of a NIOSH-certified respirator with an 
APF of at least 10 where there is potential inhalation exposure, (3) 
involving domestic manufacture, (4) other than as described in the PMN, 
(5) where the annual manufacture and importation volume exceeds 1,000 
kilograms, or (6) in the form of a powder or a solid may cause serious 
health effects. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD 
Test Guideline 413) would help characterize the human health effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10278.

PMN Number P-10-246

    Chemical name: Multi-walled carbon nanotubes (generic) (P-10-246).
    CAS number: Not available.
    Effective date of the TSCA section 5(e) consent order: April 4, 
2011.
    Basis for the TSCA section 5(e) consent order: The PMN states that 
the use of the substance will be as a conductivity additive to resins, 
rubber, and battery electrodes. The order was issued under TSCA 
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that 
this substance may present an unreasonable risk of injury to human 
health or the environment. To protect against these risks, the order: 
(1) Requires use of personal protective equipment including gloves and 
protective clothing impervious to the chemical substance, and at 
minimum, a NIOSH-certified air-purifying, tight-fitting full-face 
respirator equipped with N-100, P-100, or R-100 cartridges or power air 
purifying particulate

[[Page 81454]]

respirator with an APF of at least 50; (2) prohibits the domestic 
manufacture of the PMN substance; (3) restricts use of the PMN 
substance to the uses specified in the consent order; (4) prohibits 
release of the PMN substance into the waters of the United States 
during processing and use activities; and (5) requires corresponding 
recordkeeping. The proposed SNUR would designate as a ``significant new 
use'' the absence of these protective measures.
    Toxicity concern: Based on test data for analogous chemicals 
including other carbon nanotubes there are concerns for pulmonary 
toxicity, fibrosis, carcinogenicity, mutagenicity, and immunotoxicity 
of the PMN substances. Based on test data on respirable, poorly soluble 
particulates, EPA has concerns for lung effects. There are also data 
suggesting that pulmonary deposition of some nanoscale materials, 
including carbon nanotubes in the agglomerated form, may induce 
cardiovascular toxicity when these nanoscale materials are inhaled. The 
major health concerns are for potential pulmonary toxicity, fibrosis, 
and cancer to workers exposed via inhalation. Sublethal effects have 
been noted for some carbon nanoscale substances in fish at levels as 
low as 100 ppb. Further studies need to be conducted before EPA can 
determine a concentration of concern. Such studies must measure actual 
concentrations of carbon nanotubes and control for the effects of 
contaminants, solvents, and physical factors such as blockage of gills 
or intestines.
    Recommended testing: EPA has determined that the results of the 
following tests would help characterize possible effects of the PMN 
substance. The PMN submitter has agreed not to exceed a specified 
production time limit before performing these tests on the PMN 
substance: A 90-day inhalation toxicity test (OPPTS Test Guideline 
870.3465 or OECD Test Guideline 413) in rats with a post exposure 
observation period of up to 3 months, including a BALF analysis, a 
determination of cardiovascular toxicity (clinically-based blood/plasma 
protein analyses), and histopathology of the heart and certain material 
characterization data.
    CFR citation: 40 CFR 721.10279.

PMN Number P-10-476

    Chemical name: Benzene, ethenyl-, polymer with 1,3-butadiene.
    CAS number: 1195978-93-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer additive. Based 
on analogous high molecular weight polymers, EPA identified concerns 
for potential lung overload from exposure to the PMN substance via 
inhalation. Specifically, EPA predicts potential toxicity to consumers 
and the general population from inhalation of respirable particles of 
10 microns or less of the PMN substance where the average number 
molecular weight is greater than 10,000 daltons. Further, based on the 
physical/chemical properties of the PMN substance, EPA has concluded, 
if the PMN substance were manufactured where the average number 
molecular weight is less than 1,000 daltons, the PMN substance may be 
considered persistent, bio-accumulative, and toxic (PBT), as described 
in the New Chemical Program's PBT category (64 FR 60194; November 4, 
1999) (FRL-6097-7). EPA estimates, if the PMN substance were 
manufactured where the average number molecular weight is less than 
1,000 daltons, that the PMN substance will persist in the environment 
more than six months and estimates a bioaccumulation factor of greater 
than or equal to 1,000. For the manufacturing method, processing 
method, and use described in the PMN, significant inhalation exposures 
are unlikely, and the PMN is not considered to be a PBT. Accordingly, 
EPA has not determined that the proposed manufacturing method, 
processing method, or use of the substance as described in the PMN 
notice may present an unreasonable risk. EPA has determined, however, 
that any manufacturing method, processing method, or use of the PMN 
substance where greater than 5 percent of the particles are in the 
respirable range of 10 microns or less and the average number molecular 
weight is greater than 10,000 daltons may cause serious health effects. 
EPA has also determined that any manufacturing method, processing 
method, or use of the PMN substance where the average number molecular 
weight is less than 1,000 daltons may cause significant adverse 
environmental effects and may be characterized as a potential PBT 
substance. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170 (b)(3)(ii), (b)(4)(ii), and 
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
following testing would help characterize the possible human health 
effects and potential PBT attributes of the PMN substance: A 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465 or OECD Test 
Guideline 413) with a 60-day holding period (for the PMN substance 
where greater than 5 percent is in the respirable range of 10 microns 
or less and the average number molecular weight is greater than 10,000 
daltons) and the tiered testing described in the New Chemicals 
Program's PBT Category (64 FR 60194; November 4, 1999) (FRL-6097-7) 
(for the PMN substance where the average number molecular weight is 
less than 1,000 daltons). Test reports should include protocols 
approved by EPA, certificate of analysis for the test substance, raw 
data, and results.
    CFR citation: 40 CFR 721.10280.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these proposed SNURs, EPA concluded that for 15 of 
the 17 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 proposed SNUR provisions for these chemical substances 
are consistent with the provisions of the TSCA section 5(e) consent 
orders. These SNURs are being proposed pursuant to Sec.  
[emsp14]721.160.
    In the other 2 cases, where the uses were 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 proposing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this proposed rule:
     EPA would 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 would 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 would 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

[[Page 81455]]

regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
     EPA would 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 https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.

VI. Notice and Comment Procedures

    EPA is issuing these SNURs by notice and comment procedure, as 
described in Sec.  721.170(d)(4). In accordance with Sec.  
721.170(d)(4)(ii)(A), persons are being given the opportunity to submit 
comments on or before January 27, 2012 on whether EPA should establish 
notification requirements.

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

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this proposed 
rule have undergone premanufacture review. TSCA section 5(e) consent 
orders have been issued for 15 chemical substances and the PMN 
submitters are prohibited by the TSCA section 5(e) consent orders from 
undertaking activities which EPA is designating as significant new 
uses. EPA is soliciting comments on whether any of the uses proposed as 
significant new uses are ongoing.
    As discussed in the Federal Register of April 24, 1990, 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 proposed rule rather than as of the effective date 
of the final rule. If uses begun after publication of the proposed rule 
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 
final, and then argue that the use was ongoing before the effective 
date of the final rule. Thus, persons who begin commercial manufacture, 
import, or processing of the chemical substances that would be 
regulated through these proposed SNURs will have to cease any such 
activity before the effective date of the rule if and when finalized. 
To resume their activities, these persons would have to comply with all 
applicable SNUR notice requirements and wait until the notice review 
period, including all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with 
these proposed SNURs before the effective date. If a person were to 
meet the conditions of advance compliance under Sec.  
[emsp14]721.45(h), the person would be 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. There are two 
exceptions:
    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 also 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 the TSCA section 5(e) consent orders for 15 of the chemical 
substances regulated under this proposed rule, EPA has established 
restrictions 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 restrictions will 
not be removed until EPA determines that the unrestricted use will not 
present an unreasonable risk of injury or result in significant or 
substantial exposure or environmental release. This determination is 
usually made based on the results of the required or recommended 
toxicity tests.
    In cases where EPA issued a TSCA section 5(e) consent order that 
requires or recommends certain testing, Unit IV. lists tests required 
or recommended in each of the section 5(e) consent orders underlying 
the proposed 5(e) SNURs, and lists tests recommended for the substances 
subject to the proposed 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 OPPTS Test Guidelines referenced in 
this document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at 
https://www.sourceoecd.org. The American Society for Testing and 
Materials International (ASTM) standards are available at https://www.astm.org/Standard/index.shtml. To access the European standard, EN 
15051 method, issued by The European Committee for Standardization 
(CEN), please go to https://www.cen.eu/cen/products. To access EPA 
Method 1320, please go to https://www.epa.gov/osw/hazard/testmethods/sw846/pdfs/1320.pdf.
    When physical/chemical properties of test material and/or material 
characterization tests are recommended for nanoscale substances that 
are the subject of this proposed rule, you should take into 
consideration the characterizations identified in the Guidance Manual 
for the Testing of Manufactured Nanomaterials: OECD's Sponsorship 
Programme, which is available at https://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2009)20/rev&doclanguage=en.
    The recommended testing specified in Unit IV. of this document 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. 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

[[Page 81456]]

submitting a PMN, including submission of test data on health and 
environmental effects as described in Sec.  720.50. SNUNs must be 
submitted to EPA on EPA Form No. 7710-25 in accordance with the 
procedures set forth in Sec.  721.25 and Sec.  720.40. Forms and 
information are available on-line at https://www.epa.gov/opptintr/newchems.

X. 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 proposed rule. EPA's complete 
Economic Analysis is available in the docket under docket ID number 
EPA-HQ-OPPT-2010-0279.

XI. References

    The following is a listing of the documents that have been placed 
in the proposed rule phase of the docket under docket ID number EPA-HQ-
OPPT-2010-0279, which is available for inspection as specified under 
ADDRESSES.
    1. Cheng, X., Kan, A.T., and Tomson, M.B. Napthalene Adsorption and 
Desorption from Aqueous C60 Fullerene. Journal of Chemical & 
Engineering Data. 2004, 49 (3), 675-683.
    2. Brant, J., Lecoanet, H., Hotze, M., and Wiesner, M. Comparison 
of Electrokinetic properties of Colloidal Fullerenes (n-C60) 
Formed Using Two Procedures. Environmental Science & Technology 2005, 
39 (17), 6343-6351.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for several new chemical 
substances that were the subject of PMNs, and, 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 would amend the table 
in 40 CFR part 9 to list the OMB approval number for the information 
collection requirements contained in these proposed SNURs, if the SNURs 
are subsequently issued as final rules. This listing of the OMB control 
numbers and their subs