Significant New Use Rules on Certain Chemical Substances, 35977-35989 [2010-15334]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 121 (Thursday, June 24, 2010)]
[Rules and Regulations]
[Pages 35977-35989]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15334]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2008-0920; FRL-8824-6]
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 17 
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 17 chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. The required notification will provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: This rule is effective on August 23, 2010. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
July 8, 2010.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before July 26, 2010 (see Unit VI. of the SUPPLEMENTARY 
INFORMATION).
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0920, by one of the following methods:

[[Page 35978]]

     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-2008-0920. 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-
2008-0920. 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 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.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28 (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 July 26, 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.

[[Page 35979]]

    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) (see 
Unit III.). Once EPA determines that a use of a chemical substance is a 
significant new use, TSCA section 5(a)(1)(B) requires persons to submit 
a significant new use notice (SNUN) to EPA at least 90 days before they 
manufacture, import, or process the chemical substance for that use. 
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. 
2612) import certification requirements codified 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. 2611 (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 17 
chemical substances that are the subject of these SNURs, EPA considered 
relevant information about the toxicity of the chemical substances, 
likely human exposures and environmental releases associated with 
possible uses, and the four bulleted TSCA section 5(a)(2) factors 
listed in this unit.

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 17 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     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

[[Page 35980]]

underlying consent orders. The 5(e) SNURs designate as a ``significant 
new use'' the absence of the protective measures required in the 
corresponding consent orders.
    Where EPA 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 15 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). However, EPA does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  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-02-996
Chemical name: Aliphatic triamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the chemical substance will be 
used as a monomer for polymers with amide or imide links; a crosslinker 
for epoxy type coatings, adhesives and sealants; a crosslinker for 
epoxy type composites; a monomer for urea and urethane urea polymers 
used in coatings; a chemical intermediate for functional chemicals: 
amides, imides; a chemical intermediate for functional chemicals: 
isocyanates, salts; and a chemical intermediate for functional 
chemicals: cyclic amines, etc. Based on test data on the PMN substance 
and analogous substances, EPA identified concerns for corrosion of the 
skin, eyes, mucous membranes and lungs; respiratory tract irritation; 
immunotoxicity; developmental toxicity; and reproductive toxicity from 
exposure to the PMN substance. In addition, based on test data on the 
PMN substance, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 48 parts per billion (ppb) of the PMN 
substance in surface waters. For the use described in the PMN, worker 
inhalation and dermal exposures are not expected and releases to water 
are 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 involving an application method which generates a vapor, 
mist, or aerosol may cause serious health effects and 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)(3)(i), 
(b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of the 
following testing would help characterize the human health and 
environmental effects of the PMN substance: Either a 90-day inhalation 
toxicity test (OCSPP Harmonized Test Guideline 870.3465) in rodents, 
modified for a 28-day exposure, or a repeated dose inhalation toxicity 
study (Organization for Co-Operation and Development (OECD) 412 test 
guideline); a prenatal developmental toxicity study (OCSPP Harmonized 
Test Guideline 870.3700) via the oral route; a reproduction and 
fertility study (OCSPP Harmonized Test Guideline 870.3800) via the oral 
route; an immunotoxicity test (OCSPP Harmonized Test Guideline 
870.7800) via the oral route; a fish chronic toxicity test (OCSPP 
Harmonized Test Guideline 850.1400); and a daphnid chronic toxicity 
test (OCSPP Harmonized Test Guideline 850.1300). All recommended tests 
should be performed on the PMN substance neutralized with HCl to a pH 
of 7.0. Further, a certificate of analysis should be included for the 
test substance.
CFR citation: 40 CFR 721.10184.
PMN Number P-03-106
Chemical name: 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-
isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene 
glycol and reduced Me esters of reduced polymd. oxidized 
tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts).
CAS number: 328389-90-8.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a surface treatment agent. Based on 
test data on analogous substances, EPA believes this substance could 
cause lung toxicity to workers if inhaled, via irritation to mucous 
membranes and cationic binding with membranes. For the use described in 
the PMN, significant worker dermal or inhalation 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 involving an application method which generates a vapor, 
mist, or aerosol may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity study (OCSPP Harmonized Test Guideline 870.3465) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10185.

PMN Number P-04-132
Chemical name: Ethylhexyl oxetane (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: March 7, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance

[[Page 35981]]

will be as an additive for industrial applications. The order was 
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based 
on findings that this substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the consent order requires use of dermal personal protective 
equipment, including gloves demonstrated by testing to be impervious 
(Polyvinyl Alcohol gloves with a thickness of no less than 31.3 mils or 
Silvershield/4H sleeves with a thickness of no less than 2.7 mils have 
been shown to satisfy this requirement for up to 8 hours), requires the 
establishment of a hazard communication program, and limits uses to 
those listed in the consent order. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
Toxicity concern: Based on test data on the PMN substance, EPA 
identified concerns for liver toxicity, thyroid toxicity, and systemic 
toxicity. Further, based on test data on the PMN substance, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 20 ppb of the PMN substance in surface waters.
Recommended testing: EPA has determined that the following tests would 
help characterize the human health and environmental effects of the PMN 
substance: A 90-day oral toxicity test (OCSPP Harmonized Test Guideline 
870.3100) in rodents; a fish early-life stage toxicity test (OCSPP 
Harmonized Test Guideline 850.1400) with rainbow trout; and a daphnid 
chronic toxicity test (OCSPP Harmonized Test Guideline 850.1300). The 
order does not require submission of the aforementioned information at 
any specified time or production volume. However, the order's 
restrictions on manufacturing, 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 721.10186.
PMN Number P-05-186
Chemical names: (Chemical A) 4-Morpholinepropanamine, N-(1,3-
dimethylbutylidene)-; (Chemical B) Fatty acids, tall-oil, reaction 
products with 4-methyl-2-pentanone and aliphatic polyamine (generic); 
(Chemical C) Fatty acids, tall-oil, reaction products with 
(butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, 
morpholinepropanamine, propylene glycol diamine and aliphatic 
polyamine, N-(1,3 -dimethylbutylidene) derivs (generic); and (Chemical 
D) Formaldehyde, polymer with aliphatic diamine and phenol, reaction 
products with 4-methyl-2-pentanone (generic).
CAS numbers: (Chemical A) 1003863-30-6; (Chemical B) not available; 
(Chemical C) not available; and (Chemical D) not available.
Basis for action: The PMN states that the substances will be used as 
curing agents for epoxy coating systems. Based on test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 10 ppb of the PMN in surface 
waters. For the uses described in the PMN, releases of the substances 
are not expected to result in surface waters concentrations that exceed 
10 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in surface water concentrations exceeding 10 ppb 
may cause significant adverse environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substances: A fish acute toxicity test, freshwater and marine 
(OCSPP Harmonized Test Guideline 850.1075) using the static method with 
24-hour renewal intervals; a fish acute toxicity test mitigated by 
humic acid (OCSPP Harmonized Test Guideline 850.1085) using the static 
method with 24-hour renewal intervals; an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OCSPP Harmonized Test Guideline 
850.1010) using the static method with 24-hour renewal intervals; and 
an algal toxicity test, tiers I and II (OCSPP Harmonized Test Guideline 
850.5400) using the static method. For all fish and daphnid testing, 
the dilution water must have a water hardness of less than 180 mg/L 
calcium carbonate and a total organic carbon (TOC) level of less than 
2.0 mg/L. Further, the stock solution should be adjusted to a pH of 7 
at study initiation prior to the introduction of test organisms. Study 
reports must include chemical names, CAS numbers, and composition of 
the test substance.

CFR citations: 40 CFR 721.10187 (P-05-186, Chemical A); 40 CFR 
721.10188 (P-05-186, Chemical B); 40 CFR 721.10189 (P-05-186, Chemical 
C); and 40 CFR 721.10190 (P-05-186, Chemical D).
PMN Numbers P-06-262, P-06-263, and P-06-264
Chemical names: (P-06-262) Amides, coco, N-[3-(dibutylamino)propyl]; 
(P-06-263, Chemical A) Amides, coco, N-[3-(dibutylamino)propyl], 
acrylates; (P-06-263, Chemical B) 1-Butanaminium, N-(3-aminopropyl)-N-
butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner salts; and (P-06-
264) Dialkylcocoamidoalkylpropionate (generic).
CAS numbers: (P-06-262) 851544-20-2; (P-06-263, Chemical A) 851545-09-
0; (P-06-263, Chemical B) 851545-17-0; and (P-06-264) not available.
Basis for action: The consolidated PMN states that the substances will 
be used as intermediates for hydrate inhibitors for oil and gas wells, 
production pipelines and flowlines (P-06-262); and hydrate inhibitors 
for oil and gas wells, production pipelines and flowlines (P-06-263 and 
P-06-264). Based on test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 20 ppb of the PMN substances in surface waters. For the uses 
described in the PMNs, these substances will not be released to surface 
waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OCSPP Harmonized Test 
Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP 
Harmonized Test Guideline 850.5400); a ready biodegradability test 
(OCSPP Harmonized Test Guideline 835.3110); and an activated sludge 
sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help 
characterize the environmental effects of the PMN substances. Testing 
should be performed on P-06-264. Further, a certificate of analysis 
should be included for the test substances.

CFR citations: 40 CFR 721.10191 (P-06-262); 40 CFR 721.10192 (P-06-263, 
Chemical A); 40 CFR 721.10193 (P-06-263, Chemical B); and 40 CFR 
721.10194 (P-06-264).
PMN Numbers P-06-265, P-06-266, and P-06-267

[[Page 35982]]

Chemical names: (P-06-265) Dialkylcornoilamidoalkylamine (generic); (P-
06-266, Chemical A) Dialkylcornoilamidoacrylate (generic); (P-06-266, 
Chemical B) Dialkycornoilamidoalkylbetaine (generic); and (P-06-267) 
Dialkylcornoilamidopropionate (generic).
CAS numbers: (P-06-265) Not available; (P-06-266, Chemical A) not 
available; (P-06-266, Chemical B) not available; and (P-06-267) not 
available.
Basis for action: The consolidated PMN states that the substances will 
be used as intermediates for hydrate inhibitors for oil and gas wells, 
production pipelines and flowlines (P-06-265); and hydrate inhibitors 
for oil and gas wells, production pipelines and flowlines (P-06-266 and 
P-06-267). Based on test data on analogous aliphatic amines, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 20 ppb of the PMN substances in surface waters. For the uses 
described in the PMNs, these substances will not be released to surface 
waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substances resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substances meet the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OCSPP Harmonized Test 
Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP 
Harmonized Test Guideline 850.5400); a ready biodegradability test 
(OCSPP Harmonized Test Guideline 835.3110); and an activated sludge 
sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help 
characterize the environmental effects of the PMN substances. Testing 
should be performed on P-06-267. Further, a certificate of analysis 
should be included for the test substances.

CFR citations: 40 CFR 721.10195 (P-06-265); 40 CFR 721.10196 (P-06-266, 
Chemical A); 40 CFR 721.10197 (P-06-266, Chemical B); and 40 CFR 
721.10198 (P-06-267).
PMN Number P-06-702
Chemical name: Substituted aliphatic amine (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 26, 2009.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance will be as a polymer 
curative. The order was issued under sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) of TSCA based on findings that this substance may 
present an unreasonable risk of injury to the environment and human 
health. To protect against these risks, the consent order requires use 
of dermal personal protective equipment, including gloves demonstrated 
by testing to be impervious (Ansell NEOX style 9-912 gloves have been 
shown to satisfy this requirement for up to 110 minutes), use of 
respiratory personal protective equipment, including a National 
Institute of Occupational Safety and Health (NIOSH)-approved 
respiratory protection with an APF of at least 50 or compliance with a 
New Chemical Exposure Limit (NCEL) of 0.14 mg/m\3\ as an 8-hour time-
weighted average, establishment of a hazard communication program, and 
restricts releases to water. The SNUR designates as a ``significant new 
use'' the absence of these protective measures.
Toxicity concern: Based on test data on analogous substances, EPA 
identified concerns for chronic liver toxicity, acute oral toxicity and 
corrosion to membranes, dermal toxicity, inhalation toxicity, dermal 
and eye irritation to workers exposed to the PMN substance. EPA set the 
NCEL at 0.14 mg/m\3\ as an 8-hour time-weighted average. In addition, 
based on test data on the PMN substance, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb of the 
PMN substance in surface waters.
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the health and environmental 
effects of the PMN substance: A primary skin irritation test (OECD 404 
test guideline); a primary eye irritation test (OECD 405 test 
guideline); a 28-day repeated dose (OECD 407 test guideline) gavage in 
rats, a fish early life stage toxicity test (OCSPP Harmonized Test 
Guideline 850.1400); and a daphnid chronic toxicity test (OCSPP 
Harmonized Test Guideline 850.1300). The PMN submitter has agreed not 
to exceed the production volume limit without performing the primary 
skin irritation test (OECD 404 test guideline); primary eye irritation 
test (OECD 405 test guideline); and 28-day repeated dose test (OECD 407 
test guideline) gavage in rats. The order does not require submission 
of the fish early life-stage toxicity test and the daphnid chronic 
toxicity test at any specified time or production volume. However, the 
order's restrictions on manufacturing, 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 721.10199.
PMN Number P-09-75
Chemical name: Benzenacetonitrile, cyclohexylidene-alkyl substituted 
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the PMN substance will be as a component of odorant compositions 
for highly-dispersive applications. Based on test data on the PMN 
substance, EPA predicts chronic toxicity to aquatic organisms at 
concentrations that exceed 123 ppb of the PMN substance in surface 
waters. For the processing and use scenario and production volume in 
the amended PMN, releases of the substance are not expected to result 
in surface water concentrations that exceed 123 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 that exceed 123 ppb, or exceedance of the annual maximum 
manufacturing and importation limit of 10,000 kg, may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(I).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish early life stage toxicity test (OCSPP 
Harmonized Test Guideline 850.1400) and a field testing for aquatic 
organisms test (OCSPP Harmonized Test Guideline 850.1950). The fish 
early-life stage test should be performed using the flow-through method 
with measured concentrations. Further, a certificate of analysis should 
be provided for the test substance. EPA recommends conducting the early 
life stage fish test first, as the results of this test may affect the 
choice of species for subsequent field testing.
CFR citation: 40 CFR 721.10200.

V. Rationale and Objectives of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are the subjects of these SNURs, EPA

[[Page 35983]]

concluded that for 2 of the 17 chemical substances, regulation was 
warranted under TSCA section 5(e), pending the development of 
information sufficient to make reasoned evaluations of the health or 
environmental effects of the chemical substances. The basis for such 
findings is outlined in Unit IV. Based on these findings, TSCA section 
5(e) consent orders requiring the use of appropriate exposure controls 
were negotiated with the PMN submitters. The 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 15 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 August 23, 2010 without further notice, unless EPA 
receives written adverse or critical comments, or notice of intent to 
submit adverse or critical comments before July 26, 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 July 26, 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

    Significant new use designations for a chemical substance are 
legally established as of the date of publication of this direct final 
rule June 24, 2010.
    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, 
other persons may engage in a significant new use as defined in this 
rule before the effective date of the rule. However, 12 of the 17 
chemical substances contained in this rule have CBI chemical 
identities, and since EPA has received a limited number of post-PMN 
bona fide submissions (per Sec. Sec.  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. To access the Harmonized Test Guidelines referenced 
in this document electronically, please go to

[[Page 35984]]

https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.'' 
The Organisation for Economic Co-operation and Development (OECD) test 
guidelines are available from the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
    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, SNUN submitting for 
significant new use 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, 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 Sec.  
720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in 
accordance with the procedures set forth in Sec. Sec.  721.25 and 
720.40. This form is available from the Environmental Assistance 
Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Forms and information are also available electronically at https://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

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

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

[[Page 35985]]

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 1,400 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).

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

[[Page 35986]]

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


    Dated: June 17, 2010.
Wendy C. Hamnett,
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.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.


0
2. The table in Sec.  9.1 is amended by adding the following sections 
in numerical order under the undesignated center heading ``Significant 
New Uses of Chemical Substances'' to read as follows:


Sec.  9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                   40 CFR citation                      OMB control No.
------------------------------------------------------------------------
                                * * * * *
 
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
                                * * * * *
721.10184............................................          2070-0012
721.10185............................................          2070-0012
721.10186............................................          2070-0012
721.10187............................................          2070-0012
721.10188............................................          2070-0012
721.10189............................................          2070-0012
721.10190............................................          2070-0012
721.10191............................................          2070-0012
721.10192............................................          2070-0012
721.10193............................................          2070-0012
721.10194............................................          2070-0012
721.10195............................................          2070-0012
721.10196............................................          2070-0012
721.10197............................................          2070-0012
721.10198............................................          2070-0012
721.10199............................................          2070-0012
721.10200............................................          2070-0012
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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


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4. Add Sec.  721.10184 to subpart E to read as follows:


Sec.  721.10184  Aliphatic triamine (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aliphatic triamine (PMN P-02-996) is subject to reporting under this 
section for the significant new uses described in paragraph (a)(2) of 
this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(y)(1).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The pro