Significant New Use Rules on Certain Chemical Substances, 47877-47888 [E9-22533]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 180 (Friday, September 18, 2009)]
[Rules and Regulations]
[Pages 47877-47888]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22533]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2009-0729; FRL-8430-3]
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 12 
chemical substances which were the subject of premanufacture notices 
(PMNs). Two of these chemical substances are subject to TSCA section 
5(e) consent orders issued by EPA. This action requires persons who 
intend to manufacture, import, or process any of these 12 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 November 17, 2009 without 
further notice, unless EPA receives written adverse or critical 
comments, or notice of intent to submit adverse or critical comments 
before October 19, 2009. This rule shall be promulgated for purposes of 
judicial review at 1 p.m. (e.s.t.) on October 2, 2009.
    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 October 19, 2009, 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 September 18, 2009. 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 October 19, 2009 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-2009-0729, 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

[[Page 47878]]

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-2009-0729. 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-
2009-0729. 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 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 after October 19, 2009 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.

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    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 12 
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.

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 12 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 2 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

[[Page 47880]]

measures required in the corresponding consent orders.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA section 5(e) consent order for the same 
chemical substance.
    This rule also includes SNURs on 10 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-05-775
Chemical name: Benzeneethanol,halo-,halocycloalkyl-,hydrazinealkyl- 
(generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 8, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an 
intermediate used in a closed process. 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 human 
health and the environment. To protect against this risk, the consent 
order requires dermal protection, hazard communication, and water 
release restrictions. The SNUR designates as a ``significant new use'' 
the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance, analogous 
hydrazines and other (confidential) moieties of the PMN substance, EPA 
identified concerns for mutagenicity, skin sensitization, liver 
toxicity, kidney toxicity, neurotoxicity, and eye irritation from 
dermal exposure. Further, based on test data for analogous hydrazines, 
EPA predicts aquatic toxicity at concentrations that exceed 0.1 parts 
per billion (ppb) from releases of the PMN substance to the 
environment.
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 fish early-life stage 
toxicity test (OPPTS Harmonized Test Guideline 850.1400); a daphnid 
chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400); a repeated dose oral toxicity in rodents with reproductive, 
developmental and neurotoxicity screening (Organisation for Economic 
Co-operation and Development (OECD) 422 test guideline) for a duration 
of 90-days; a bacterial reverse mutation test (OPPTS Harmonized Test 
Guideline 870.5100); and a mammalian erythrocyte micronucleus test 
(OPPTS Harmonized Test Guideline 870.5395) via the intraperitoneal 
route. Depending upon the results of mutagenicity testing, a two year 
carcinogenicity study (OPPTS Harmonized Test Guideline 870.4200) may be 
warranted. Further, a certificate of analysis should be provided for 
the test substance. The order does not require the submission of the 
aforementioned information at any specified time or production volume. 
However, the order's restrictions on manufacture, import, processing, 
distribution in commerce, use, and disposal of the PMN substance will 
remain in effect until the order is modified or revoked by EPA based on 
submission of that or other relevant information.
CFR citation: 40 CFR 721.10157.
PMN Number P-06-16
Chemical name: 2-Pentanone, 3,5-dichloro-.
CAS number: 58371-98-5.
Effective date of TSCA section 5(e) consent order: May 8, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as an 
intermediate used in a closed process. 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 human 
health and the environment. To protect against this risk, the consent 
order requires dermal and respiratory protection, hazard communication, 
and water release restrictions. The SNUR designates as a ``significant 
new use'' the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance and analogous 
haloketones, EPA identified concerns for acute inhalation toxicity, 
mutagenicity, developmental toxicity, skin sensitization, systemic 
toxicity, and neurotoxicity from inhalation or dermal exposure. 
Further, based on test data on analogous neutral organic chemicals and 
haloketones, and potential excess toxicity due to reactivity 
(hydrolysis), EPA predicts aquatic toxicity at concentrations that 
exceed 0.1 ppb resulting from releases of the PMN substance to the 
environment.
Recommended testing: EPA has determined that the results of the 
following tests would help characterize possible human health and 
environmental effects of the PMN substance: A fish early-life stage 
toxicity test (OPPTS Harmonized Test Guideline 850.1400); a daphnid 
chronic toxicity test (OPPTS Harmonized Test Guideline 850.1300); an 
algal toxicity test, tiers I and II (OPPTS Harmonized Test Guideline 
850.5400); a repeated dose oral toxicity in rodents with reproductive, 
developmental and neurotoxicity screening (OECD 422 test guideline) for 
a duration of 90-days; a

[[Page 47881]]

bacterial reverse mutation test (OPPTS Harmonized Test Guideline 
870.5100); and a mammalian erythrocyte micronucleus test (OPPTS 
Harmonized Test Guideline 870.5395) via the intraperitoneal route. 
Depending upon the results of mutagenicity testing, a 2-year 
carcinogenicity study (OPPTS Harmonized Test Guideline 870.4200) may be 
warranted. Further, a certificate of analysis should be provided for 
the test substance. The order does not require the submission of the 
aforementioned information at any specified time or production volume. 
However, the order's restrictions on manufacture, import, processing, 
distribution in commerce, use, and disposal of the PMN substance will 
remain in effect until the order is modified or revoked by EPA based on 
submission of that or other relevant information.
CFR citation: 40 CFR 721.10158.
PMN Number P-07-587
Chemical name: 1-Docosanamine, N,N-dimethyl-.
CAS number: 21542-96-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. Based on test 
data on the PMN substance and analogous aliphatic amines, 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, 
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)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test mitigated by humic acid (OPPTS Harmonized Test 
Guideline 850.1085) would help characterize the environmental effects 
of the PMN substance. The test substance should be the chloride salt of 
the PMN substance at pH 7. Further, a certificate of analysis should be 
provided for the test substance.
CFR citation: 40 CFR 721.10159.
PMN Number P-07-629
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-[(13Z)-1-oxo-13-
docosen-1-yl]-.omega.-[[(13Z)-1-oxo-13-docosen-1-yl]oxy]-.
CAS number: 56565-72-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a polymer additive. Based on test data 
on analogous nonionic surfactants, EPA predicts toxicity to aquatic 
organisms may occur 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 use 
of the substance other than as described in the PMN could result in 
exposures which may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Harmonized Test Guideline 835.3110); a 
fish acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an 
aquatic invertebrate acute toxicity test with 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. 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 721.10160.
PMN Number P-08-3
Chemical name: Substituted silyl methacrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an 
intermediate for a paint binder. Based on test data on analogous 
acrylates and neutral organic chemicals, 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, 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 a 
hydrolysis as a function of pH test (OPPTS Harmonized Test Guideline 
835.2120) and a ready biodegradability test (OPPTS Harmonized Test 
Guideline 835.3110) would help characterize the possible fate 
attributes of the PMN substance. If the results of the ready 
biodegradation test demonstrate that the hydrolysis product remains 
intact, then a shake-flask die-away test (OPPTS Harmonized Test 
Guideline 835.3170) and a fish bioconcentration test (OPPTS Harmonized 
Test Guideline 850.1730) may be warranted. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10161.
PMN Number P-08-24
Chemical name: 1,3 Dioxolane-4-butanol, 2-ethenyl-.
CAS number: 2421-08-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a crosslinking agent to be ultimately 
used in the manufacture of automotive and aircraft coating materials. 
Based on test data on an expected hydrolysis product for an analogous 
chemical, EPA has concerns for mutagenicity, oncogenicity, 
developmental toxicity, liver toxicity, kidney toxicity, and skin 
sensitization and irritation for the PMN substance. As 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 use of the substance other than as described in the PMN 
could result in exposures which 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 repeated 
dose 28-day oral toxicity study (OPPTS Harmonized Test Guideline 
870.3050) in rodents would help characterize the human health effects 
of the PMN substance.
CFR citation: 40 CFR 721.10162.
PMN Number P-08-33
Chemical name: Chloro fluoro alkane (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. EPA identified 
health and environmental concerns because the substance may be a 
persistent, bioaccumulative, and toxic (PBT) chemical, based on 
physical/chemical properties of the PMN substance, as

[[Page 47882]]

described in the New Chemicals Program's PBT Category (64 FR 60194; 
November 4, 1999) (FRL-6097-7). EPA estimates that the PMN substance 
will persist in the environment for more than six months and estimates 
a bioaccumulation factor of greater than or equal to 1,000. Also, based 
on test data on analogous haloalkanes, EPA predicts toxicity to aquatic 
organisms. As described in the PMN, significant worker exposure is 
unlikely and the substance is not released to surface waters. 
Therefore, EPA has not determined that the proposed processing or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that domestic manufacture, exceedance of the annual import 
volume limit of 50,000 kilograms, or any predictable or purposeful 
release containing the PMN substance into the waters of the United 
States may cause serious health effects and significant adverse 
environmental effects, since the PMN substance has been characterized 
by EPA as a PBT. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170 (b)(3)(ii), (b)(4)(ii), and 
(b)(4)(iii).
Recommended testing: EPA has determined that the results of the tiered 
testing as described in the New Chemicals Program's PBT Category would 
help characterize the PBT attributes of the PMN substance. The fish 
bioconcentration factor (BCF) test should be conducted using the flow 
through method with measured concentrations and include a certificate 
of analysis for the test substance showing percentage and level of 
impurities; measured BCF should be based on 100% active ingredient and 
measured concentrations.
CFR citation: 40 CFR 721.10163.
PMN Number P-08-36
Chemical name: Benzenecarboximidamide, N-hydroxy-4-nitro-.
CAS number: 1613-86-1.
Basis for action: The PMN states that 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 400 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not expected to be 
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 a fish 
acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an 
aquatic invertebrate acute toxicity test with 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 
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 721.10164.
PMN Number P-08-138
Chemical name: Carbonotrithioic acid, bis(phenylmethyl) ester.
CAS number: 26504-29-0.
Basis for action: The PMN states that the substance will be used as a 
chain transfer agent. EPA identified health and envronmental concerns 
because the substance may be a PBT chemical, based on physical/chemical 
properties of the PMN substance, as described in the New Chemicals 
Program's PBT Category (64 FR 60194, November 4, 1999). EPA estimates 
that the PMN substance will persist in the environment for more than 
two months and estimates a bioaccumulation factor of greater than or 
equal to 5,000. Also, based on test data for analogous esters, EPA 
predicts toxicity to aquatic organisms. As described in the PMN, 
significant worker exposure is unlikely and the substance is not 
released to surface waters. Therefore, EPA has not determined that the 
proposed processing or use of the substance may present an unreasonable 
risk. EPA has determined, however, that domestic manufacture or any 
predictable or purposeful release containing the PMN substance into the 
waters of the United States may cause serious health effects and 
significant adverse environmental effects, since the PMN substance has 
been characterized by EPA as a PBT. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170 (b)(3)(ii), 
(b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the tiered 
testing described in the New Chemicals Program's PBT Category would 
help characterize the PBT attributes of the PMN substance. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10165.
PMN Number P-08-180
Chemical name: 1,3-Cyclohexanedione, 2-[2-chloro-4-(methylsulfonyl)-3-
[(2,2,2-trifluoroethoxy)methyl]benzoyl]-, ion(1-), potassium salt 
(1:1).
CAS number: 1121649-70-4.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a precursor to another chemical 
substance. Based on test data on the PMN substance, EPA has concerns 
for developmental and systemic toxicity in humans. EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
0.1 ppb of the PMN substance in surface waters. As described in the 
PMN, significant worker exposure is not expected for the use described 
and the substance will not be released to surface waters in amounts 
resulting in surface water concentrations that exceed 0.1 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 waters concentrations that exceed 0.1 ppb may cause serious 
health effects and significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(i) and (b)(4)(i).
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 porous pot test (OPPTS 
Harmonized Test Guideline 835.3220); and either (1) a sediment/water 
microcosm biodegradation test (OPPTS Harmonized Test Guideline 
835.3180), (2) a site-specific aquatic microcosm test, laboratory 
(OPPTS Harmonized Test Guideline 850.1925), or (3) a field testing for 
aquatic organisms (OPPTS Harmonized Test Guideline 850.1950).
CFR citation: 40 CFR 721.10166.
PMN Number P-08-212
Chemical name: Tetrafluoro nitrotoluene (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. Based on test 
data on analogous neutral organic chemicals, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 200 ppb of 
the PMN substance in surface waters. As described in the PMN, the 
substance is not expected to be released to surface

[[Page 47883]]

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 a fish 
acute toxicity test (OPPTS Harmonized Test Guideline 850.1075); an 
aquatic invertebrate acute toxicity test with 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 
daphnia testing should be performed using the flow-through method with 
measured concentrations. Algal testing should be preformed using the 
static method with measured concentrations. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10167.
PMN Number P-08-275
Chemical name: Cesium tungsten oxide.
CAS number: 52350-17-1.
Basis for action: The PMN states that the substance will be used as a 
component of infrared absorption material. Based on test data on 
analogous crystalline respirable, poorly soluble particulates, EPA has 
concerns for lung overload and lung cancer for the PMN substance. As 
described in the PMN, significant worker exposure is unlikely as dermal 
absorption is not expected and inhalation exposures are expected to be 
negligible because the PMN substance is used in aqueous form. 
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 manufacturing, processing, or use of 
the substance as a solid may cause serious health effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity study (OPPTS Harmonized Test Guideline 870.3465) 
with a 60-day holding period in rats and with special attention to the 
histopathology of the lungs would help characterize the human health 
effects of the PMN substance. Depending on the results of this testing, 
a 2-year inhalation carcinogenicity study (OPPTS Harmonized Test 
Guideline 870.4200) may be warranted.
CFR citation: 40 CFR 721.10168.

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 2 of the 12 
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 10 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 November 17, 2009 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before October 19, 2009.
    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 October 19, 2009, 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 2 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,

[[Page 47884]]

other persons may engage in a significant new use as defined in this 
rule before the effective date of the rule. However, 4 of the 12 
chemical substances contained in this rule have CBI chemical 
identities, and since EPA has received a limited number of post-PMN 
bona fide submissions (per Sec.  720.25 and Sec.  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 at https://www.epa.gov/opptsfrs/home/guidelin.htm. 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.
    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 most of the chemical 
identities of the chemical substances subject to these SNURs are also 
CBI, manufacturers, importers, and processors can combine the bona fide 
submission under the procedure in Sec.  721.1725(b)(1) with that under 
Sec.  721.11 into a single step.
    If EPA determines that the use identified in the bona fide 
submission would not be a significant new use, i.e., the use does not 
meet the criteria specified in the rule for a significant new use, that 
person can manufacture, import, or process the chemical substance so 
long as the significant new use trigger is not met. In the case of a 
production volume trigger, this means that the aggregate annual 
production volume does not exceed that identified in the bona fide 
submission to EPA. Because of confidentiality concerns,

[[Page 47885]]

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.  721.25 and Sec.  
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 address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of these SNURs will not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is discussed in this unit. The requirement to submit a SNUN 
applies to any person (including small or large entities) who intends 
to engage in any activity described in the rule as a ``significant new 
use.'' Because these uses are ``new,'' based on all information 
currently available to EPA, it appears that no small or large entities 
presently engage in such activities. A SNUR requires that any person 
who intends to engage in such activity in the future must first notify 
EPA by submitting a SNUN. Although some small entities may decide to 
pursue a significant new use in the future, EPA cannot presently 
determine how many, if any, there may be. However, EPA's experience to 
date is that, in response to the promulgation of over 1,000 SNURs, the 
Agency receives on average only 5 notices per year. Of those SNUNs 
submitted from 2006-2008, only one appears to be from a small entity. 
In addition, the estimated reporting cost for submission of a SNUN (see 
Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA 
believes that the potential economic impacts of complying with these 
SNURs are not expected to be significant or adversely impact a 
substantial number of small entities. In a SNUR that published in the 
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency 
presented its general determination that final SNURs are not expected 
to have a significant economic impact on a substantial number of small 
entities, which was provided to the Chief Counsel for Advocacy of the 
Small Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government will be impacted by this rule. As 
such, EPA has determined that this rule does not impose any enforceable 
duty, contain any unfunded mandate, or otherwise have any affect on 
small governments subject to the requirements of sections 202, 203, 
204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public 
Law 104-4).

E. Executive Order 13132

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

[[Page 47886]]

F. Executive Order 13175

    This rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This does 
not significantly or uniquely affect the communities of Indian Tribal 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of Executive Order 13175, 
entitled Consultation and Coordination with Indian Tribal Governments 
(65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This action is not subject to Executive Order 13211, entitled 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use and 
because this action is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9
    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721
    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: September 11, 2009.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U