Significant New Use Rules on Certain Chemical Substances, 4983-4996 [2010-1936]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 20 (Monday, February 1, 2010)]
[Rules and Regulations]
[Pages 4983-4996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1936]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2008-0918; FRL-8438-4]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 15 
chemical substances which were the subject of premanufacture notices 
(PMNs). Three of these chemical substances are subject to TSCA section 
5(e) consent orders issued by EPA. This action requires persons who 
intend to manufacture,

[[Page 4984]]

import, or process any of these 15 chemical substances for an activity 
that is designated as a significant new use by this rule to notify EPA 
at least 90 days before commencing that activity. The required 
notification will provide EPA with the opportunity to evaluate the 
intended use and, if necessary, to prohibit or limit that activity 
before it occurs.

DATES: The effective date of this rule is April 2, 2010 without further 
notice, unless EPA receives written adverse or critical comments, or 
notice of intent to submit adverse or critical comments before March 3, 
2010. This rule shall be promulgated for purposes of judicial review at 
1 p.m. (e.s.t.) on February 16, 2010.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before March 3, 2010, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    Significant new use designations for a chemical substance are 
legally established as of the date of publication of this direct final 
rule February 1, 2010. See the discussion in Unit VII. for more 
specific details.
    Any persons intending to import or export a chemical substance that 
is the subject of this rule on or after March 3, 2010 are subject to 
the TSCA section 13 import certification requirements and the export 
notification provisions of TSCA section 12(b). See the discussion in 
Unit I.A. and Unit II.C. for more specific details.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0918, 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-2008-0918. 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-
2008-0918. 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://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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail 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 general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
    For technical information contact: Tracey Klosterman, Chemical 
Control Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail 
address: klosterman.tracey@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR

[[Page 4985]]

127.28 (the corresponding EPA policy appears at 40 CFR part 707, 
subpart B). Chemical importers must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA. Importers of chemicals subject to these SNURs must certify their 
compliance with the SNUR requirements. In addition, any persons who 
export or intend to export a chemical substance that is the subject of 
this rule on or March 3, 2010 are subject to the export notification 
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec.  
721.20), and must comply with the export notification requirements in 
40 CFR part 707, subpart D.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture, import, or processing of a chemical 
substance for any activity designated by these SNURs as a significant 
new use. Receipt of such notices allows EPA to assess risks that may be 
presented by the intended uses and, if appropriate, to regulate the 
proposed use before it occurs. Additional rationale and background to 
these rules are more fully set out in the preamble to EPA's first 
direct final SNUR published in the Federal Register 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 those listed in TSCA section 5(a)(2). 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. The mechanism 
for reporting under this requirement is established under Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same notice requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA 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.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C. 
1612) import certification requirements promulgated at 19 CFR 12.118 
through 12.127, and 19 CFR 127.28 (the corresponding EPA policy appears 
at 40 CFR part 707, subpart B). 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. In addition, any persons who export or intend to export a 
chemical substance identified in a final SNUR are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2612 (b)) (see 
Sec.  721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

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 15 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four factors listed in TSCA section 5(a)(2) and 
this unit.

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IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 15 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).
     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 rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes 3 PMN substances that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA 
determined that activities associated with the PMN substances may 
present unreasonable risk to human health or the environment. Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNURs'' on these PMN substances are promulgated pursuant to 
Sec.  721.160, and are based on and consistent with the provisions in 
the underlying consent orders. The 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    This rule also includes SNURs on 12 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). EPA, however, does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-5(e) SNURs issued under Sec.  721.170 satisfies the two 
requirements stipulated in Sec.  721.170(c)(2), i.e., these significant 
new use activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental 
concerns identified'' for the PMN substance.
PMN Number P-03-141
Chemical name: Cyclopentane, methoxy-.
CAS number: 5614-37-9.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an industrial solvent. Based on test 
data on the PMN substance, EPA has identified concerns for systemic 
toxicity and neurotoxicity. For the use described in the PMN, 
significant worker exposure is not expected. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance other than as described in the 
PMN may cause serious health effects. Based on this information, the 
PMN substance meets the concern criteria at Sec.  721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the human health effects of the 
PMN substance: A 90-day oral toxicity test in rodents (OPPTS Harmonized 
Test Guideline 870.3100); a flammability test (OPPTS Harmonized Test 
Guideline 830.6315); a sediment and soil adsorption/desorption isotherm 
test (OPPTS Harmonized Test Guideline 835.1220); and a standard 
practice for determination of odor and taste threshold by a forced-
choice ascending concentration series method of limits (American 
Society for Testing and Materials (ASTM) E679-04 test guideline).
CFR citation: 40 CFR 721.10169.
PMN Number P-03-197
Chemical name: Polyoxyethylene polyalkylarylphenylether sulfate 
ammonium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a surface active agent for emulsion 
polymerization. Based on test data on analogous anionic surfactants, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 5 parts per billion (ppb) of the PMN substance in surface 
waters. For the use described in the PMN, releases of the substance are 
not expected to result in surface waters concentrations that exceed 5 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as described in the PMN may cause significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Harmonized Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400) would help characterize the environmental effects of the PMN 
substance. All aquatic toxicity testing should be performed using the 
flow-through method with measured concentrations. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10170.
PMN Number P-03-285
Chemical name: 1H-benz(e)indolium, 1,1,2,3-tetramethyl-, 4-
methylbenzenesulfonic acid (1:1).
CAS number: 141914-99-0.
Basis for action: The PMN states that the substance will be used as a 
chemical intermediate for the manufacture of a dye in imaging media/
products. Based on test data on the PMN substance, EPA identified 
concerns for acute lethality from inhalation of the PMN substance. As 
described in the PMN, worker inhalation exposure will be minimal due to 
the use of adequate personal protective equipment. Therefore, EPA has 
not determined that the proposed manufacturing, processing, or use of 
the substance may present an unreasonable risk. EPA has determined, 
however, that use of the substance without the use of a National 
Institute for Occupational Safety and Health (NIOSH)-approved 
respirator with an assigned protection factor (APF) of at least 10 
where there is a potential for inhalation exposure, or exceedance of 
the 11,000 kilogram annual manufacture and import volume may cause 
serious health effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(3)(i).

[[Page 4987]]

Recommended testing: EPA has determined that the results of a repeated 
dose 28-day oral toxicity in rodents (OPPTS Harmonized Test Guideline 
870.3050 or Organisation for Economic Co-operation and Development 
(OECD) 407 test guideline) would help characterize the human health 
effects of the PMN substance.
CFR citation: 40 CFR 721.10171.
PMN Number P-03-633
Chemical name: Alkylamide derivative (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a raw material for the manufacture of 
photosensitive materials. Based on test data on analogous substances, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 1 ppb of the PMN substance in surface waters. As described 
in the PMN, releases of the substance are not expected to result in 
surface water concentrations that exceed 1 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Harmonized Test Guideline 
850.1400); a daphnid chronic toxicity test (OPPTS Harmonized Test 
Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS 
Harmonized Test Guideline 850.5400) would help characterize the 
environmental effects of the PMN substance. Fish and daphnia testing 
should be performed using the flow-through method with measured 
concentrations. Algal testing should be performed using the static 
method with measured concentrations. Further, a certificate of analysis 
should be provided for the test substance.
CFR citation: 40 CFR 721.10172.
PMN Number P-03-793
Chemical name: Silanamine,1,1,1-triethoxy-N,N-diethyl-.
CAS number: 35077-00-0.
Basis for action: The PMN states that the substance will be used as an 
external donor for olefin polymerization. Based on submitted test data, 
EPA has identified health concerns for corrosion. Also, based on test 
data on analogous alkoxysilanes and aliphatic amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
10 ppb of the PMN substance in surface waters. As described in the PMN, 
significant worker exposure is unlikely and releases to surface waters 
are not expected. Therefore, EPA has not determined that the proposed 
import, processing, or use of the substance may present an unreasonable 
risk. EPA has determined, however, that domestic manufacture of the 
substance could result in exposures which may cause serious health 
effects and significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Harmonized Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400) would help characterize the environmental effects of the PMN 
substance. Fish and daphnid testing should be performed using the flow-
through method with measured concentrations. Algal toxicity testing 
should be performed using the static method with measured 
concentrations. No human health testing is recommended at this time. 
Further, a certificate of analysis should be provided for the test 
substance.
CFR citation: 40 CFR 721.10173.
PMN Number P-04-139
Chemical name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-
, N-peanut-oil acyl derivs., inner salts.
CAS number: 691401-28-2.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an oil well additive. Based on test 
data on analogous substances, EPA identified concerns for irritation, 
possible corrosion, and developmental toxicity. For the use described 
in the PMN, worker inhalation exposure is not expected and worker 
dermal exposures will be minimal due to the use of adequate personal 
protective equipment. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that use of the 
substance without the use of impervious gloves where there is a 
potential for dermal exposure, or use of the substance other than as 
described in the PMN 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 prenatal 
developmental toxicity test (OPPTS Harmonized Test Guideline 870.3700) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10174.
PMN Number P-04-141
Chemical name: 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-
dimethyl-3-sulfo-, N-(C12-18 and C18-unsatd. acyl) derivs., inner 
salts.
CAS number: 691400-36-9.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be used as an additive for various cleaners. 
Based on test data on analogous amphoteric surfactants, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 6 
ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the substance are not expected to result in surface water 
concentrations that exceed 6 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in surface water concentrations 
exceeding 6 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a porous 
pot test (OPPTS Harmonized Test Guideline 835.3220); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Harmonized 
Test Guideline 850.1010); and an algal toxicity test, tiers I and II 
(OPPTS Harmonized Test Guideline 850.5400) would help characterize the 
environmental effects of the PMN substance. Daphnid testing should be 
performed using the flow-through method with measured concentrations. 
Algal testing should be performed using the static method with measured 
concentrations. Further, a certificate of analysis should be provided 
for the test material.
CFR citation: 40 CFR 721.10175.
PMN Number P-04-144
Chemical name: Amides, peanut-oil, N-[3-(dimethylamino)propyl].
CAS number: 691400-76-7.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be used as a chemical intermediate. Based on 
test data on analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed

[[Page 4988]]

1 ppb of the PMN substance in surface waters. As described in the PMN, 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in release to surface 
waters may cause significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OPPTS Harmonized Test Guideline 850.1075); a fish acute toxicity test 
mitigated by humic acid (OPPTS Harmonized Test Guideline 850.1085) with 
the chloride salt adjusted to a pH of 7; an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS Harmonized Test Guideline 
850.1010); and an algal toxicity test, tiers I and II (OPPTS Harmonized 
Test Guideline 850.5400). All aquatic toxicity testing should be 
performed using the static method with measured concentrations. 
Further, a certificate of analysis should be provided for the test 
substance.
CFR citation: 40 CFR 721.10176.
PMN Number P-04-153
Chemical name: Phosphoric acid, yttrium(3+) salt (1:1).
CAS number: 13990-54-0.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a phosphor. Based on test data on 
analogous inorganic phosphates and soluble yttrium compounds, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 6 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the substance are not expected to result in 
surface water concentrations that exceed 6 ppb. Therefore, EPA has not 
determined that the proposed import, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that domestic manufacture or any use of the substance 
resulting in surface water concentrations exceeding 6 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Harmonized Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400) would help characterize the environmental effects of the PMN 
substance. All aquatic toxicity testing should be performed using the 
static method with measured concentrations of yttrium. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10177.
PMN Number P-04-319
Chemical name: Distillates (Fischer-Tropsch), hydroisomerized middle, 
C10-13-branched alkane fraction.
CAS number: 642928-30-1.
Basis for action: The PMN states that the substance will be used as 
industrial/commercial paint and ink formulations; indoor industrial 
heating oil; and solvent blend for industrial cleaning. Based on test 
data on structurally similar chemicals with a carbon chain range of C5 
to C21, EPA has identified health concerns for liver toxicity, kidney 
toxicity, developmental toxicity, mutagenicity, cancer, neurotoxicity, 
skin sensitization, hydrocarbon pneumonia, and irritation to mucous 
membranes. Also, based on test data on analogous neutral organic 
compounds, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, worker dermal and inhalation exposure 
will be minimal due to the use of adequate personal protective 
equipment, and releases to water are not expected. Therefore, EPA has 
not determined that the proposed import, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that use of the substance without the use of impervious gloves 
where there is the potential for dermal exposure, use of the substance 
without the use of a NIOSH-approved respirator with an APF of at least 
100 where there is potential for inhalation exposure, domestic 
manufacturing, or any use of the substance resulting in release to 
surface waters, may cause serious health effects and significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170 (b)(1)(i)(C), 
(b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the human health and 
environmental effects of the PMN substance: A prenatal developmental 
toxicity test (OPPTS Harmonized Test Guideline 870.3700), using one 
species via the oral route; a fish early-life stage toxicity test 
(OPPTS Harmonized Test Guideline 850.1400) with fathead minnows, a 
daphnid chronic toxicity test (OPPTS Harmonized Test Guideline 
850.1300); and an algal toxicity test, tiers I and II (OPPTS Harmonized 
Test Guideline 850.5400). Fish and daphnid testing should be performed 
using the flow-through method with measured concentrations. Dilution 
water total organic carbon (TOC) concentration should be less than 2.0 
mg TOC per liter. Algal testing should be performed using the static 
method with measured concentrations. Further, a certificate of analysis 
should be provided for the test substance.
CFR citation: 40 CFR 721.10178.
PMN Numbers P-04-346 and P-04-347
Chemical name: Copolymers of phenol and aromatic hydocarbon (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: November 15, 2004.
Basis for TSCA section 5(e) consent order: The consolidated PMN states 
that the generic (non-confidential) use of the substances will be as 
binder components. The order was issued under sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I) of TSCA, based on a finding that these substances 
may present an unreasonable risk of injury to the environment. To 
protect against this risk, the consent order requires the company to 
not manufacture or import the PMN substances unless the average 
molecular weight is greater than 500 daltons. To ensure compliance, the 
consent order also requires that the substances be analyzed both at the 
time of initial commencement and annually thereafter. The SNUR 
designates as a ``significant new use'' the absence of these protective 
measures.
Toxicity concern: Based on test data on analogous phenols, EPA predicts 
toxicity to aquatic organisms varies with the average number molecular 
weight of the PMN substances. As the average number molecular weight 
decreases, the aquatic toxicity of the substances increases. When the 
average molecular weight is 366 daltons, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb of the 
PMN substances in surface waters. The PMN substances with a molecular 
weight greater than 500 daltons are of lower concern for toxicity 
because the expected water solubility is estimated to be less than 1 
ppb.
Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Harmonized Test Guideline 
850.1400), a daphnid chronic toxicity test (OPPTS Harmonized Test 
Guideline 850.1300);

[[Page 4989]]

and an algal toxicity test, tiers I and II (OPPTS Harmonized Test 
Guideline 850.5400) would help characterize possible environmental 
effects of the PMN substances. Fish and daphnid testing should be 
performed using the flow-through method with measured concentrations. 
Algal testing should be performed using the static method with measured 
concentrations. EPA should be consulted to determine what form of the 
chemical substances should be tested. The order does not require 
submission of the testing at any specified time or production volume. 
However, the order's restrictions on manufacture, import, processing, 
distribution in commerce, use and disposal of the chemical substances 
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 721.10179.
PMN Number P-04-692
Chemical name: Trifunctional acrylic ester (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: December 6, 2004.
Basis for TSCA section 5(e) consent order: The PMN states that the 
substance will be used in lacquer/dry film manufacture. The order was 
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based 
on a finding that this substance may present an unreasonable risk of 
injury to the environment. To protect against this risk, the consent 
order requires the company to not manufacture or import the PMN 
substance unless the mean number of moles of the ethoxy group is 
greater than or equal to 8. To ensure compliance, the consent order 
also requires that the substance be analyzed both at the time of 
initial commencement and annually thereafter. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
Toxicity concern: Based on test data on analogous esters, EPA predicts 
toxicity to aquatic organisms varies with the average number of moles 
of the ethoxy group. As the number of moles of ethoxy group decreases, 
the aquatic toxicity of the substance increases. For the PMN substance 
with an average of 3 moles of ethoxy, EPA predicts toxicity to aquatic 
organisms at concentrations that exceed 40 ppb of the PMN substance in 
surface waters.
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Harmonized Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400) would help characterize the environmental effects of the PMN 
substance. Fish and daphnid testing should be performed using flow-
through method with measured concentrations. Algal testing should be 
performed using the static method with measured concentrations. EPA 
should be consulted to determine what form of the chemical substance 
should be tested. The order does not require submission of the testing 
at any specified time or production volume. However, the order's 
restrictions on manufacture, import, processing, distribution in 
commerce, use and disposal of the chemical 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 721.10180.
PMN Number P-07-453
Chemical name: Halide salt of an alkylamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a solder adjuvant, an open, non-
dispersive use. Based on test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms at concentrations that exceed 20 
ppb of the PMN substance in surface waters. For the use described in 
the PMN, releases of the substance are not expected to result in 
surface water concentrations that exceed 20 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance other than as described in the 
PMN could result in release to surface waters which may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS Harmonized Test 
Guideline 850.1075); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Harmonized Test Guideline 850.1010); and an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400) would help characterize the environmental effects of the PMN 
substance. All aquatic toxicity testing should be performed using the 
static method with nominal concentrations. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10181.
PMN Number P-07-601
Chemical name: 1-Propene, 2,3,3,3-tetrafluoro-.
CAS number: 754-12-1.
Basis for action: The PMN states that the substance will be used as a 
motor vehicle air conditioning (MVAC) refrigerant in new passenger cars 
and vehicles (i.e., as defined in 40 CFR 82.32 (c) and (d)). Initial 
charging of MVAC units with the PMN substance will be done by the motor 
vehicle original equipment manufacturer. All servicing, maintenance, 
and disposal involving the PMN substance will be done only by Clean Air 
Act (CAA) section 609 certified technicians using CAA section 609 
certified refrigerant handling equipment. Based on test data on the PMN 
substance, EPA identified health concerns for developmental toxicity 
and lethality to workers and consumers if they were exposed to a 
significant amount of the PMN substance via inhalation. The PMN 
substance has an ozone depletion potential of zero, and based on test 
data, has a low global warming potential (GWP100 of about 
4). For the use scenario described in the PMN, significant industrial 
or commercial worker exposure is unlikely due to the use of CAA section 
609 certified refrigerant handling equipment and other protective 
measures. Potential consumer (vehicle passenger) exposure from 
refrigerant leaks into the passenger compartment of a vehicle is not 
expected to present significant risk of serious health effects. 
Flammability concerns with the PMN substance are being addressed 
through regulatory actions by EPA's Office of Air and Radiation (see 
the following paragraph). Further, ``do-it-yourself'' consumer 
exposures are not expected because the PMN substance only will be sold 
or distributed in 20-pound containers or larger. Therefore, EPA has not 
determined that the manufacturing, processing, or use of the substance 
as described in the PMN may present an unreasonable risk. EPA has 
determined, however, that (1) use of the substance other than as a MVAC 
refrigerant in new passenger cars and vehicles as defined in 40 CFR 
82.32 (c) and (d), (2) initial charging of MVAC units with the PMN 
substance by any person other than CAA section 609 certified 
technicians without using CAA section 609 certified refrigerant 
handling equipment, (3) servicing, maintenance, and disposal involving 
the PMN substance by persons other than CAA section 609 certified 
technicians without using CAA section 609 certified refrigerant

[[Page 4990]]

handling equipment, or (4) sale or distribution of the PMN substance in 
containers smaller than 20-pounds (net weight) may cause serious health 
effects in accordance with 40 CFR 721.170(b)(3)(i).
    This SNUR is intended to complement recently proposed and 
forthcoming regulations on the PMN substance under the CAA in that this 
SNUR addresses health risk issues of the subject refrigerant. On 
October 19, 2009, EPA published a proposed rule on the PMN substance 
entitled ``Protection of Stratospheric Ozone: New Substitute in the 
Motor Vehicle Air Conditioning Sector under the Significant New 
Alternatives Policy (SNAP) Program'' (74 FR 53445) (FRL-8969-7). The 
SNAP Program, mandated under section 612 of the CAA, requires EPA to 
develop a program for evaluating alternatives to ozone-depleting 
substances and to create lists of substitutes for specific uses that do 
not present greater overall risk to human health and the environment 
than other alternatives that are available. In the October 19, 2009, 
action, EPA proposed to find HFO-1234yf acceptable, subject to certain 
use conditions, as a substitute for CFC-12 in new motor vehicle air 
conditioning systems (passenger cars and trucks). The proposed use 
conditions include incorporation of engineering strategies and/or 
devices to mitigate flammability risks for this substance (see Unit V. 
of the proposed rule). Use of most flammable refrigerants, including 
the PMN substance, in existing MVAC systems as a retrofit has 
previously been determined by EPA to be unacceptable. The proposed rule 
would require a petition and a new SNAP submission specifically for the 
use of the PMN substance in existing MVAC equipment as a retrofit 
before EPA would consider allowing such use (see Unit VI. of the 
proposed rule). EPA also intends to promulgate a follow-on rulemaking 
under section 609 of the CAA to address service equipment, technician 
certification, and end-of-life disposal specifications.
Recommended testing: EPA has determined that the results of an acute 
inhalation toxicity study (OPPTS Harmonized Test Guideline 870.1300 or 
OECD 403 test guideline) with rabbits would help characterize the human 
health effects of the PMN substance. Exposure concentrations of 10,000, 
50,000, and 100,000 parts per million (ppm) should be used. Further, 
rabbits should be exposed for 1 hour, and pregnant rabbits should be 
exposed on Gravid Day 12.
CFR citation: 40 CFR 721.10182.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for 3 of the 15 
chemical substances, regulation was warranted under TSCA section 5(e), 
pending the development of information sufficient to make reasoned 
evaluations of the health or environmental effects of the chemical 
substances. The basis for such findings is outlined in Unit IV. Based 
on these findings, TSCA section 5(e) consent orders requiring the use 
of appropriate exposure controls were negotiated with the PMN 
submitters. The SNUR provisions for these chemical substances are 
consistent with the provisions of the TSCA section 5(e) consent orders. 
These SNURs are promulgated pursuant to Sec.  721.160.
    In the other 12 cases, where the uses are not regulated under a 
TSCA section 5(e) consent order, EPA determined that one or more of the 
criteria of concern established at Sec.  721.170 were met, as discussed 
in Unit IV.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
     EPA will receive notice of any person's intent to 
manufacture, import, or process a listed chemical substance for the 
described significant new use before that activity begins.
     EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
     EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6, or 7.
     EPA will ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA 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/newchems/pubs/invntory.htm.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  721.160(c)(3) and Sec.  721.170(d)(4). In accordance with Sec.  
721.160(c)(3)(ii) and Sec.  721.170(d)(4)(i)(B), the effective date of 
this rule is April 2, 2010 without further notice, unless EPA receives 
written adverse or critical comments, or notice of intent to submit 
adverse or critical comments before March 3, 2010.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before March 3, 2010, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    This rule establishes SNURs for a number of chemical substances. 
Any person who submits adverse or critical comments, or notice of 
intent to submit adverse or critical comments, must identify the 
chemical substance and the new use to which it applies. EPA will not 
withdraw a SNUR for a chemical substance not identified in the comment.

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

    To establish a significant ``new'' use, EPA must determine that the 
use is not ongoing. The chemical substances subject to this rule have 
undergone premanufacture review. TSCA section 5(e) consent orders have 
been issued for 3 chemical substances and the PMN submitters are 
prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which EPA is designating as significant new uses. In cases 
where EPA has not received a notice of commencement (NOC) and the 
chemical substance has not been added to the TSCA Inventory, no other 
person may commence such activities without first submitting a PMN. For 
chemical substances for which an NOC has not been submitted at this 
time, EPA concludes that the uses are not ongoing. However, EPA 
recognizes that prior to the effective date of the rule, when chemical 
substances identified in this SNUR are added to the TSCA Inventory, 
other persons may engage in a significant new use as defined in this 
rule before the effective date of the rule. However, 6 of the 15 
chemical substances contained in this rule have

[[Page 4991]]

CBI chemical identities, and since EPA has received a limited number of 
post-PMN bona fide submissions (per Sec. Sec.  720.25 and 721.11), the 
Agency believes that it is highly unlikely that any of the significant 
new uses described in the regulatory text of this rule are ongoing.
    As discussed in the Federal Register of April 24, 1990, EPA has 
decided that the intent of TSCA section 5(a)(1)(B) is best served by 
designating a use as a significant new use as of the date of 
publication of this direct final rule rather than as of the effective 
date of the rule. If uses begun after publication were considered 
ongoing rather than new, it would be difficult for EPA to establish 
SNUR notice requirements because a person could defeat the SNUR by 
initiating the significant new use before the rule became effective, 
and then argue that the use was ongoing before the effective date of 
the rule. Thus, persons who begin commercial manufacture, import, or 
processing of the chemical substances regulated through this SNUR will 
have to cease any such activity before the effective date of this rule. 
To resume their activities, these persons would have to comply with all 
applicable SNUR notice requirements and wait until the notice review 
period, including all extensions, expires (see Unit III.).
    EPA has promulgated provisions to allow persons to comply with this 
SNUR before the effective date. If a person meets the conditions of 
advance compliance under Sec.  721.45(h), the person is considered 
exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any 
particular test data before submission of a SNUN, except where the 
chemical substance subject to the SNUR is also subject to a test rule 
under TSCA section 4 (see TSCA section 5(b)). Persons are required only 
to submit test data in their possession or control and to describe any 
other data known to or reasonably ascertainable by them (see Sec.  
720.50). However, upon review of PMNs and SNUNs, the Agency has the 
authority to require appropriate testing. In cases where EPA issued a 
TSCA section 5(e) consent order that requires or recommends certain 
testing, Unit IV. lists those tests. Unit IV. also lists recommended 
testing for non-5(e) SNURs. Descriptions of tests are provided for 
informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. Many OPPTS Harmonized Test Guidelines are now 
available on the Internet. Please go to https://www.epa.gov/oppts and 
select ``Test Methods and Guidelines'' on the left-side navigation 
menu. 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 (ASTM) test guidelines are 
available at https://www.astm.org/standard/index.shtml.
    In the TSCA section 5(e) consent orders for several of the chemical 
substances regulated under this rule, EPA has established production 
volume limits in view of the lack of data on the potential health and 
environmental risks that may be posed by the significant new uses or 
increased exposure to the chemical substances. These limits cannot be 
exceeded unless the PMN submitter first submits the results of toxicity 
tests that would permit a reasoned evaluation of the potential risks 
posed by these chemical substances. Under recent TSCA section 5(e) 
consent orders, each PMN submitter is required to submit each study at 
least 14 weeks (earlier TSCA section 5(e) consent orders required 
submissions at least 12 weeks) before reaching the specified production 
limit. Listings of the tests specified in the TSCA section 5(e) consent 
orders are included in Unit IV. The SNURs contain the same production 
volume limits as the TSCA section 5(e) consent orders. Exceeding these 
production limits is defined as a significant new use. Persons who 
intend to exceed the production limit must notify the Agency by 
submitting a SNUN at least 90 days in advance of commencement of non-
exempt commercial manufacture, import, or processing.
    The recommended tests may not be the only means of addressing the 
potential risks of the chemical substance. However, SNUNs submitted for 
significant new uses without any test data may increase the likelihood 
that EPA will take action under TSCA section 5(e), particularly if 
satisfactory test results have not been obtained from a prior PMN or 
SNUN submitter. EPA recommends that potential SNUN submitters contact 
EPA early enough so that they will be able to conduct the appropriate 
tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

IX. Procedural Determinations

    By this rule, EPA is establishing certain significant new uses 
which have been claimed as CBI subject to Agency confidentiality 
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a 
final determination or other disposition of the confidentiality claim 
under 40 CFR part 2 procedures, EPA is required to keep this 
information confidential. EPA promulgated a procedure to deal with the 
situation where a specific significant new use is CBI. This rule cross-
references Sec.  721.1725(b)(1) and is similar to that in Sec.  721.11 
for situations where the chemical identity of the chemical substance 
subject to a SNUR is CBI. This procedure is cross-referenced in each 
SNUR that includes specific significant new uses that are CBI.
    Under these procedures a manufacturer, importer, or processor may 
request EPA to determine whether a proposed use would be a significant 
new use under the rule. The manufacturer, importer, or processor must 
show that it has a bona fide intent to manufacture, import, or process 
the chemical substance and must identify the specific use for which it 
intends to manufacture, import, or process the chemical substance. If 
EPA concludes that the person has shown a bona fide intent to 
manufacture, import, or process the chemical substance, EPA will tell 
the person whether the use identified in the bona fide submission would 
be a significant new use under the rule. Since many of the chemical 
identities of the chemical substances subject to these SNURs are also 
CBI, manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  721.1725(b)(1) with that under 
Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture, import, or process the chemical substance so 
long as the significant new use trigger is not met. In the case of a 
production volume trigger, this means that the aggregate annual 
production volume does not exceed that identified in the bona fide 
submission to EPA. Because of confidentiality concerns,

[[Page 4992]]

EPA does not typically disclose the actual production volume that 
constitutes the use trigger. Thus, if the person later intends to 
exceed that volume, a new bona fide submission would be necessary to 
determine whether that higher volume would be a significant new use.

X. SNUN Submissions

    As stated in Unit II.C., according to Sec.  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 mailed to the Environmental Protection Agency, 
OPPT Document Control Office (7407M), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Information must be submitted in the form 
and manner set forth in EPA Form No. 7710-25. This form is available 
from the Environmental Assistance Division (7408M), 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001 (see Sec. Sec.  721.25 and 
720.40). Forms and information are also available electronically at 
https://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

XI. Economic Analysis

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

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

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