Document ID: EPA-HQ-OPPT-2011-0941-0177
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rule on Certain Chemical Substances
Posted Date: 2013-01-23T05:00Z

[Federal Register Volume 78, Number 15 (Wednesday, January 23, 2013)]
[Proposed Rules]
[Pages 4806-4812]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01194]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0941; FRL-6369-9]
RIN 2070-AB27

Proposed Significant New Use Rule 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 the 
Toxic Substances Control Act (TSCA) for four chemical substances which 
were the subject of premanufacture notices (PMNs). This action would 
require persons who intend to manufacture, import, or process any of 
the 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 the activity before it occurs.

DATES: Comments must be received on or before February 22, 2013.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2011-0941, 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 Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: 
Docket ID Number EPA-HQ-OPPT-2011-0941. 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-
2011-0941. 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

[[Page 4807]]

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 
proposed rule. The following list of North American Classification 
System (NAICS) codes is not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document 
applies to them. Potentially affected entities may include:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127; 
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 chemical substances 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?

    EPA is proposing these SNURs under TSCA section 5(a)(2) for four 
chemical substances which were the subject of PMNs P-07-204, P-10-58, 
P-10-59, and P-10-60. These SNURs would require persons who intend to 
manufacture, import, or process any of these chemical substances for an 
activity that is designated as a significant new use to notify EPA at 
least 90 days before commencing that activity.
    In the Federal Register issue of September 21, 2012 (77 FR 58666) 
(FRL-9357-2), EPA issued direct final SNURs on these four chemical 
substances in accordance with the procedures at Sec.  721.160(c)(3)(i). 
EPA received notice of intent to submit adverse comments on these 
SNURs. Therefore, as required by Sec.  721.160(c)(3)(ii), EPA has 
removed the direct final SNURs in a separate final rule published in 
the Federal Register, and is now issuing this proposed rule on the four 
chemical substances. The record for the direct final SNURs on these 
chemical substances was established as docket EPA-HQ-OPPT-2011-0941. 
That docket includes information considered by the Agency in developing 
the direct final rule and the notice of intent to submit adverse 
comments.

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.  [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

[[Page 4808]]

occurring before the effective date of the 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 
four chemical substances that are the subject of this proposed rule, 
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 Proposed Rule

    EPA is proposing significant new use and recordkeeping requirements 
for four chemical substances in 40 CFR part 721, subpart E. In this 
unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for TSCA 
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 proposed rule.
    The regulatory text section of this proposed 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 proposed rule, 
may be claimed as CBI. See Unit IX.
    This proposed rule includes PMN substances P-10-58, P-10-59, and P-
10-50 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. These consent orders require 
protective measures to limit exposures or otherwise mitigate the 
potential unreasonable risk. The so-called ``TSCA section 5(e) SNURs'' 
on these PMN substances are proposed pursuant to Sec.  [emsp14]721.160, 
and are based on and consistent with the provisions in the underlying 
consent orders. The TSCA section 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    This proposed rule also includes a SNUR on PMN substance P-07-204 
that was not subject to a consent order under TSCA section 5(e). In 
this case, 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.'' This so-called ``TSCA non-
section 5(e) SNUR'' is proposed pursuant to Sec.  [emsp14]721.170. EPA 
has determined that every activity designated as a ``significant new 
use'' in all TSCA non-section 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-07-204

    Chemical name: Pentane, 1,1,1,2,3,3- hexafluoro-4-(1,1,2,3,3,3- 
hexafluoropropoxy)-.
    CAS number: 870778-34-0.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a heat transfer fluid. 
Based on test data on the PMN substance and structure activity 
relationship (SAR) analysis of test data on analogous perfluorinated 
substances, EPA identified concerns for neurotoxicity and liver effects 
from exposures to the PMN substance. For the uses described in the 
amended PMN, EPA does not expect significant worker exposures due to 
the use of impervious gloves. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substance without impervious gloves, where there is a potential 
for dermal exposure; or any use of the substance other than as 
described in the amended PMN may cause serious health effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(i) and (ii).
    Recommended testing: EPA has determined that the results of a 28-
day dermal toxicity test (OPPTS Test Guideline 870.3200) in rats, a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465), and a 
test using the ``Standard Test Method for Permeation of Liquids and 
Gases through Protective Clothing Materials under Conditions of 
Continuous Contact'' (American Society for Testing and Materials (ASTM) 
International Standard F739-12) as reported in the ``Standard Guide for 
Documenting the Results of Chemical Permeation Testing of Materials 
Used in Protective Clothing'' (ASTM International Standard F1194-99 
(2010)) would help characterize the human health effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10509.

PMN Numbers P-10-58, P-10-59, and P-10-60

    Chemical names: Partially fluorinated alcohol substituted glycols 
(generic).
    CAS numbers: Not available.

[[Page 4809]]

    Effective date of TSCA section 5(e) consent order: October 8, 2010.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) uses of the PMN substances will be as 
intermediates (P-10-58 and P-10-59) and a surface active agent (P-10-
60). EPA has concerns for potential incineration or other decomposition 
products of the PMN substances. These perfluorinated decomposition 
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, 
which suggests that, under some conditions, the PMN substances 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 analogous chemical substances, 
including perfluorooctanoic acid (PFOA) and other perfluorinated 
alkyls, including the presumed environmental degradant. The 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 the environment and human 
health, 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 exposures and risks, the consent order requires 
submission of testing on the PMN substance P-10-60 at five identified 
aggregate manufacture and importation volumes; requires analysis of raw 
materials; and restricts the use of P-10-58 and P-10-59 as 
intermediates to make P-10-60. 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 TSCA 
section 5(e) consent order would help characterize possible effects of 
the PMN substances and their degradation products. The TSCA section 
5(e) consent order contains five production volume limits. The PMN 
submitter has agreed not to exceed the confidential production volume 
limits without performing the specified testing on PMN substance P-10-
60. Additional testing is included in the preamble to the TSCA section 
5(e) consent order, but this testing is not required at any specified 
time or production volume. However, the TSCA section 5(e) consent 
order's restrictions on manufacture, import, processing, distribution 
in commerce, use, and disposal of the PMN substance will remain in 
effect until the TSCA section 5(e) consent order is modified or revoked 
by EPA based on submission of that or other relevant information.
    CFR citation: 40 CFR 721.10515.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

    During review of the PMNs submitted for the four chemical 
substances that are subject to these proposed SNURs, EPA concluded that 
for three of the substances, regulation was warranted under TSCA 
section 5(e), pending the development of information sufficient to make 
reasoned evaluations of the health and environmental effects of the 
chemical substances. For one of the four substances, 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. The basis for these findings is outlined in 
Unit IV.
    Based upon comments received from the September 21, 2012 direct 
final rule, the proposed SNUR for P-10-58, P-10-59, and P-10-60 has 
been amended to be consistent with the provisions of the TSCA section 
5(e) consent order and the proposed SNUR for P-07-0204 has been amended 
to clarify the restriction at 721.80(j). This proposed rule includes 
the following changes:
    1. Revision of paragraph (a)(2)(i) for the proposed SNUR on P-10-
58, P-10-69, and P-10-60.
    2. Revision of paragraph (a)(2)(ii) for the proposed SNUR for P-07-
0204.

B. Objectives

    EPA is proposing these SNURs for specific chemical substances that 
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 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 Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Applicability of the Proposed 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 three chemical substances and the PMN 
submitters are prohibited by the TSCA section 5(e) consent orders from 
undertaking activities which EPA is designating as significant new 
uses. In cases where EPA has not received a notice of commencement 
(NOC) and the chemical substance has not been added to the TSCA 
Inventory, no other person may commence such activities without first 
submitting a PMN. For chemical substances for which an NOC has not been 
submitted at this time, EPA concludes that the uses are not ongoing. 
However, EPA recognizes that prior to the effective date of the final 
rule, when chemical substances identified in these SNURs are added to 
the TSCA Inventory, other persons may engage in a significant new use 
as defined in this proposed rule before the effective date of the final 
rule.
    As discussed in the SNURs published in the Federal Register issue 
of April 24, 1990 (55 FR 17376), EPA has decided that the intent of 
TSCA section 5(a)(1)(B) is best served by designating a use as a 
significant new use as of the date of publication of the September 21, 
2012 direct final rule rather than as of the effective date of the 
final rule for this proposed rule. If uses begun after publication were 
considered ongoing rather than new, it would be difficult for

[[Page 4810]]

EPA to establish SNUR notification requirements because a person could 
defeat the SNUR by initiating the significant new use before the 
proposed rule became an effective final rule, and then argue that the 
use was ongoing before the effective date of the final rule based on 
this proposed rule. Thus, persons who begin commercial manufacture, 
import, or processing of the chemical substances regulated through 
these SNURs will have to cease any such activity before the effective 
date of the final rule based upon this proposed rule. To resume their 
activities, these persons would have to comply with all applicable SNUR 
notification requirements and wait until the notice review period, 
including any extensions expires.
    EPA has promulgated provisions to allow persons to comply with 
these SNURs before the effective date of the final rule. 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.

VII. 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 40 CFR 
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 TSCA non-section 5(e) SNURs. Descriptions of tests are 
provided for informational purposes. EPA strongly encourages persons, 
before performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' ASTM International standards 
are available at http://www.astm.org/Standard/index.shtml.
    In the TSCA section 5(e) consent orders for three of the chemical 
substances in this proposed 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. The SNURs contain the 
same production volume limits as the TSCA section 5(e) consent order. 
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.

VIII. 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 40 CFR 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 40 CFR 720.40 and Sec.  [emsp14]721.25. E-PMN software is 
available electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers, importers, and processors of 
the chemical substances during the development of the direct final 
rule. EPA's complete economic analysis is available in the docket under 
docket ID number EPA-HQ-OPPT-2011-0941.

X. Statutory and Executive Order Reviews

A. Executive Order 12866

    This proposed rule would establish SNURs for four chemical 
substances that were the subject of PMNs, and in three cases, a TSCA 
section 5(e) consent order. The Office of Management and Budget (OMB) 
has exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993).

B. Paperwork Reduction Act (PRA)

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

[[Page 4811]]

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

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government would be impacted by this proposed 
rule. As such, EPA has determined that this proposed rule would not 
impose any enforceable duty, contain any unfunded mandate, or otherwise 
have any effect on small governments subject to the requirements of 
UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

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

F. Executive Order 13175

    This proposed rule would not have Tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
proposed rule would not significantly nor uniquely affect the 
communities of Indian Tribal governments, nor would it involve or 
impose any requirements that affect Indian Tribes. Accordingly, the 
requirements of Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this proposed 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 proposed rule is not subject to Executive Order 13211, 
entitled ``Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), 
because this action is not expected to affect energy supply, 
distribution, or use and because this action is not a significant 
regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

List of Subjects in 40 CFR Part 721

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

    Dated: January 14, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution, Prevention 
and Toxics.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 721--[AMENDED]

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

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).

0
2. Add Sec.  [emsp14]721.10509 to subpart E to read as follows:

Sec.  721.10509  Pentane, 1,1,1,2,3,3- hexafluoro-4-(1,1,2,3,3,3- 
hexafluoropropoxy)-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as pentane, 
1,1,1,2,3,3-hexafluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)-(PMN P-07-204; 
CAS No. 870778-34-0) is subject to reporting under this section for the 
significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63(a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0%), and 
(c).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(j) (applies specifically to the 
confidential uses identified in the amended premanufacture notice 
(PMN)).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph. (1) 
Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), (d), (e), and (i) are applicable to 
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (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
3. Add Sec.  [emsp14]721.10515 to subpart E to read as follows:

Sec.  721.10515  Partially fluorinated alcohol substituted glycols 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
partially fluorinated alcohol substituted glycols (PMN P-10-58, P-10-
59, and P-10-60) are subject to reporting under this section for the

[[Page 4812]]

significant new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k) (manufacture and import of the PMN 
substances according to the chemical synthesis and composition section 
of the TSCA section 5(e) consent order, including analysis, reporting, 
and limitations of maximum impurity levels of certain fluorinated 
impurities; manufacture and import of P-10-58 and P-10-59 only as 
intermediates for the manufacture of P-10-60), and (q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125(a), (b), (c), and (i) are applicable to manufacturers, 
importers, and processors of these substances, except the recordkeeping 
requirements for Sec.  721.125(b) and (c) do not apply to importers or 
processors when any one of the substances are contained in a 
formulation at less than 3 weight percent.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.
[FR Doc. 2013-01194 Filed 1-22-13; 8:45 am]
BILLING CODE 6560-50-P