Document ID: EPA-HQ-OPPT-2013-0399-0001
Agency: epa
Document Type: Rule
Title: Significant New Use Rules on Certain Chemical Substances
Posted Date: 2013-08-07T04:00Z

[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Rules and Regulations]
[Pages 48051-48068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18982]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2013-0399; FRL-9393-4]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
the Toxic Substances Control Act (TSCA) for 53 chemical substances 
which were the subject of premanufacture notices (PMNs). Seven of these 
chemical substances are subject to TSCA section 5(e) consent orders 
issued by EPA. This action requires persons who intend to manufacture 
or process any of these 53 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.

[[Page 48052]]

DATES: This rule is effective on October 7, 2013. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
August 21, 2013.
    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 September 6, 2013 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION). 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 September 6, 2013, EPA will 
withdraw the relevant sections of this direct final rule before its 
effective date.
    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-2013-0399, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. ATTN: 
Docket ID Number EPA-HQ-OPPT-2013-0399. 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-
2013-0399. EPA's policy is that all comments received will be included 
in the docket without change and may be made available at http://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at http://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at http://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or use the chemical substances contained in this rule. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Manufacturers or processors of one or more subject 
chemical substances (NAICS codes 325 and 324110), e.g., chemical 
manufacturing and petroleum refineries. This action may also affect 
certain entities through pre-existing import certification and export 
notification rules under TSCA. Chemical importers are subject to the 
TSCA section 13 (15 U.S.C. 2612) import certification requirements 
promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical 
importers must certify that the shipment of the chemical substance 
complies with all applicable rules and orders under TSCA. Importers of 
chemicals subject to these SNURs must certify their compliance with the 
SNUR requirements. The EPA policy in support of import certification 
appears at 40 CFR part 707, subpart B. In addition, any persons who 
export or intend to export a chemical substance that is the subject of 
a proposed or final SNUR, are subject to the export notification 
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see Sec.  
721.20), and must comply with the export notification requirements in 
40 CFR part 707, subpart D.

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

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.

[[Page 48053]]

    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What action is the agency taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture 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 issue of April 24, 
1990 (55 FR 17376). Consult that preamble for further information on 
the objectives, rationale, and procedures for SNURs and on the basis 
for significant new use designations, including provisions for 
developing test data.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including the four bulleted TSCA section 5(a)(2) 
factors listed in Unit III. Once EPA determines that a use of a 
chemical substance is a significant new use, TSCA section 5(a)(1)(B) 
requires persons to submit a significant new use notice (SNUN) to EPA 
at least 90 days before they manufacture or process the chemical 
substance for that use. Persons who must report are described in Sec.  
14;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.  14;721.1(c), persons subject to these SNURs must comply with 
the same SNUN requirements and EPA regulatory procedures as submitters 
of PMNs under TSCA section 5(a)(1)(A). In particular, these 
requirements include the information submission requirements of TSCA 
section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 
720. Once EPA receives a SNUN, EPA may take regulatory action under 
TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it 
has received the SNUN. If EPA does not take action, EPA is required 
under TSCA section 5(g) to explain in the Federal Register its reasons 
for not taking action.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 53 
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 53 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     Chemical Abstracts Service (CAS) Registry number (if 
assigned for non-confidential chemical identities).
     Basis for the TSCA section 5(e) consent order or, for TSCA 
non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without 
TSCA section 5(e) consent orders).
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    This rule includes PMN substances, P-09-198 and P-09-199, whose 
reported chemical names include the term ``carbon nanotube'' or 
``CNT''. Because of a lack of established nomenclature for carbon 
nanotubes, the TSCA Inventory names for carbon nanotubes are currently 
in generic form, e.g., carbon nanotube (CNT), multi-walled carbon 
nanotube (MWCNT), double-walled carbon nanotube (DWCNT), or single-
walled carbon nanotube (SWCNT). EPA uses the specific structural 
characteristics provided by the PMN submitter to more specifically 
characterize the Inventory listing for an individual CNT. All 
submitters of new chemical notices for CNTs in this SNUR have claimed 
those specific structural characteristics as CBI. EPA is publishing the 
generic chemical name along with the PMN number to identify that a 
distinct chemical substance was the subject of the PMN without 
revealing the confidential chemical identity of the PMN substance. 
Confidentiality claims preclude a more detailed description of the 
identity of these CNTs. If an intended manufacturer or processor of 
CNTs is unsure of whether its CNTs are subject to this SNUR or any 
other SNUR, the company can either contact EPA or obtain a written 
determination from EPA pursuant to the bona fide procedures at Sec.  
721.11. EPA is using the specific structural characteristics, for all 
CNTs submitted as new chemical substances

[[Page 48054]]

under TSCA, to help develop standard nomenclature for placing these 
chemical substances on the TSCA Inventory. EPA has compiled a generic 
list of those structural characteristics entitled ``Material 
Characterization of Carbon Nanotubes for Molecular Identity (MI) 
Determination & Nomenclature.'' A copy of this list is available in the 
docket for these SNURs under docket ID number EPA-HQ-OPPT-2013-0399. If 
EPA develops a more specific generic chemical name for these materials, 
that name will be made publicly available.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture 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 7 PMN substances (P-09-198, P-09-199, P-09-447, 
P-09-448, P-12-539, P-13-107, and P-13-109) that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA 
determined that activities associated with the PMN substances may 
present unreasonable risk to human health or the environment. Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNURs'' on these PMN substances are promulgated pursuant to 
Sec.  721.160 and are based on and consistent with the provisions in 
the underlying consent orders. The 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    In addition, this rule includes SNURs on 3 PMN substances (P-12-
539, P-13-107, and P-13-109) that are subject to ``exposure-based'' 
consent orders under TSCA section 5(e)(1)(A)(ii)(II), wherein EPA 
determined that the PMN substances are expected to be produced in 
substantial quantities, and that there may either be significant or 
substantial human exposure and/or the PMN substance may enter the 
environment in substantial quantities. The TSCA section 5(e) consent 
orders require submission of certain test data to EPA before the 
manufacturer may exceed a specified production volume. These SNURs 
designate as a ``significant new use'' the absence of the protective 
measures or exceedance of the production volume limit required in the 
TSCA section 5(e) consent orders.
    This rule also includes SNURs on 46 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-
section 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-section 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 Numbers P-09-198 and P-09-199

    Chemical names: Multi-walled carbon nanotubes (generic).
    CAS numbers: Not available.
    Effective date of TSCA section 5(e) consent order: June 4, 2010.
    Basis for TSCA section 5(e) consent order: The consolidated PMN 
states that the generic (non-confidential) use of the substances will 
be as additives for reinforcement. Based on test data on analogous 
respirable, poorly soluble particulates and other CNTs, EPA identified 
concerns for pulmonary toxicity, fibrosis, carcinogenicity, 
mutagenicity, and immunotoxicity. Further, available data suggests that 
pulmonary deposition of some nanoparticles, including CNT may induce 
cardiovascular toxicity if inhaled. The order was issued under section 
5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that 
these substances may present an unreasonable risk of injury to human 
health. To protect against this risk, the consent order requires:
    1. Use of personal protective equipment including gloves and 
protective clothing impervious to the substances when there is 
potential dermal exposure and a National Institute of Occupational 
Safety and Health (NIOSH)-certified full-face respirator with N-100 
cartridges when there is potential inhalation exposure.
    2. No domestic manufacture.
    3. Use of the substances only as described in the consent order.
    4. No use of the substances resulting in surface water releases 
during processing and use.
    Recommended testing: EPA has determined that the following tests 
would help characterize possible effects of the PMN substances. The PMN 
submitter has agreed not to exceed a specified production/time limit 
without performing a 90-day inhalation toxicity test (OPPTS Test 
Guideline 870.3465) in rats with a post exposure observation period of 
up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, a 
determination of cardiovascular toxicity (clinically-based blood/plasma 
protein analyses), histopathology of the heart, and certain physical/
chemical data.
    CFR citation: 40 CFR 721.10671.

PMN Numbers P-09-447 and P-09-448

    Chemical name: Sodium olefin sulfonate derivative (generic).
    CAS number: Not available.
    Effective date of TSCA section 5(e) consent order: February 15, 
2013.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of the substances will be enhanced oil 
recovery applications. Based on a CBI analog, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 10 parts per 
billion (ppb) of the aggregate of these PMN substances in surface 
waters. The consent order was issued under TSCA sections 5(e)(1)(A)(i) 
and 5(e)(1)(A)(ii)(I) based on a finding that uncontrolled manufacture, 
processing, distribution in commerce, use, and disposal of these 
substances may present an unreasonable risk of injury to the 
environment. To protect against these risks, the consent order 
requires:
    1. Establishment and use of a hazard communication program.
    2. Use of the substances only as described in the consent order.
    3. No use of the substances resulting in surface water 
concentrations exceeding 10 ppb of the aggregate of these PMN 
substances.
    Recommended testing: EPA has determined that a daphnid chronic 
toxicity test (OPPTS Test Guidelines 850.1300) and a fish early life 
stage toxicity test (OPPTS Test Guidelines 850.1400) on either P-09-447 
or P-09-448, would help characterize the environmental effects of the 
PMN substances. The order does not require the submission of these 
tests at any specified time or production volume. However, the order's 
restrictions on manufacture, processing, distribution in commerce, use, 
and disposal of the PMN substances will remain in effect

[[Page 48055]]

until the order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citation: 40 CFR 721.10672.

PMN Numbers P-12-539, P-13-107, and P-13-109

    Chemical names: Alkanes, C21-34--branched and linear, chloro (P-12-
539), Alkanes, C22-30--branched and linear, chloro (P-13-107); and 
Alkanes, C24-28, chloro (P-13-109).
    CAS numbers: 1417900-96-9 (P-12-539), 1401947-24-0 (P-13-107), and 
1402738-52-6 (P-13-109).
    Effective date of TSCA section 5(e) consent order: March 19, 2013.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
uses of the substances are as flame retardants/plasticizers in polymers 
and extreme pressure lubricants in metal working fluids (MWFs). There 
are also several CBI uses that are generically described as: 
Plasticizer and lubricant with flame retardant properties. By analogy 
to medium chain chlorinated paraffins (MCCPs--alkyl chain length of 14 
to 17), EPA expects very long chain chlorinated paraffins (vLCCPs) and 
possible degradation products to be potentially highly persistent, 
potentially bioaccumulative, and potentially toxic. Transport and 
magnification across trophic levels may also result in toxicity to 
higher organisms, including fish, higher predators, and potentially 
humans. EPA has concerns about the potential for the vLCCPs to degrade 
to shorter chain chlorinated compounds, as well as concerns about 
potential impurities or small fractions of MCCPs and/or long-chain 
chlorinated paraffins (LCCPs--alkyl chain length of 18 to 20). The 
consent order was issued under TSCA sections 5(e)(1)(A)(i), 
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based on a finding that these 
substances may present an unreasonable risk of injury to the 
environment and the substances may be produced in substantial 
quantities and may reasonably be anticipated to enter the environment 
in substantial quantities, and there may be significant (or 
substantial) human exposures to the PMN substances. To protect against 
these risks, the consent order requires:
    1. Manufacture or import of the substances at a cumulative, 
aggregate volume not to exceed 1,200,000 kilograms (kg), 14,100,000 kg, 
59,100,000 kg, 78,400,000 kg, and 86,100,000 kg unless the company has 
submitted the results of certain environmental effects studies.
    2. No manufacture of the substances with the amount of chlorinated 
paraffins with an alkyl chain <= 20 to exceed more than 1% of that PMN 
substance by weight.
    Recommended testing: EPA has determined that analysis for chain 
length and percent chlorination (for example by gas chromatography-mass 
spectrometry or high performance liquid chromatography-mass 
spectrometry (GC/MS HPLC/MS)); a modified semi-continuous activated 
sludge (SCAS) test (OPPTS Test Guideline 835.3210), modified SCAS test 
for insoluble and volatile chemicals (OPPTS Test Guideline 835.5045), 
or Zahn Wellens/EMPA test (OPPTS Test Guideline 835.3200); aerobic and 
anaerobic soil metabolism studies (Organisation for Economic Co-
operation and Development (OECD) Test Guideline 307); a bioaccumulation 
in sediment-dwelling benthic oligochaetes test (OECD Test Guideline 
315) on the PMN substances and their potential degradation products; 
and a sediment-water chironomid life-cycle toxicity test using spiked 
water or spiked sediment test (OECD Test Guideline 233) or a sediment-
water lumbriculus toxicity test using spiked sediment (OECD Test 
Guideline 225) on the PMN substances and their presumed degradation 
products would help characterize the effects of the PMN substances. 
Testing specifications are stated in the section 5(e) consent order for 
P-12-539, P-13-107, and P-13-109 available in the docket under docket 
ID number EPA-HQ-OPPT-2013-0399.
    CFR citations: 40 CFR 721.10673 (P-12-539); 40 CFR 721.10674 (P-13-
107); and 40 CFR 721.10675 (P-13-109).

PMN Number P-12-551

    Chemical name: Aromatic hydrocarbon mixture (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as feedstock for fractionation 
process. Based on test data on the PMN substance and ecological 
structural activity relationship (EcoSAR) analysis on analogous neutral 
organics, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 78 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the substance are not 
expected to result in surface water concentrations that exceed 78 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 78 ppb 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 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an 
inherent biodegradability--Concawe test (OPPTS Test Guidelines 
835.3215) would help characterize the environmental effects of the PMN 
substance. EPA also recommends that the guidance document on aquatic 
toxicity testing of difficult substances and mixtures (OECD Test 
Guideline 23) be followed to facilitate solubility in the test media, 
because of the PMN's low water solubility.
    CFR citation: 40 CFR 721.10676.

PMN Number P-12-584

    Chemical name: Alkyl phosphonate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an intermediate. Based on test 
data on an analog substance, EPA identified concerns for eye, lung, and 
mucous membrane irritation as well as kidney and developmental toxicity 
to workers exposed to the PMN substance. For the use described in the 
PMN, significant worker exposure is unlikely. Further, based on EcoSAR 
analysis of test data on analogous phosphinate esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the PMN substance are not expected to result in surface 
water concentrations that exceed 1 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance other than as an intermediate, 
any use of the substance without the use of impervious gloves when 
there is potential dermal exposure, or any use of the substance 
resulting in surface water concentrations exceeding 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)(ii) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined repeated dose toxicity with the reproduction/development 
toxicity screening test (OPPTS Test Guideline 870.3650); an algal 
toxicity test (OCSPP

[[Page 48056]]

Test Guideline 850.4500); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010); and a fish acute 
toxicity test, freshwater and marine (OPPTS Test Guideline 850.1075) 
would help characterize the human health and environmental effects of 
the PMN substance.
    CFR citation: 40 CFR 721.10677.

PMN Number P-13-10

    Chemical name: 1,4-Cyclohexanedicarboxylic acid, 1,4-dimethyl 
ester, hydrogenolysis products.
    CAS number: 1373220-73-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a chemical intermediate. Based 
on EcoSAR analysis of test data on analogous esters, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
20 ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the PMN substance are not expected to result in surface 
water concentrations that exceed 20 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 20 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that results of an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); a fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075); and an algal toxicity test (OCSPP Test 
Guideline 850.4500) would help characterize the environmental effects 
of the PMN substance.
    CFR citation: 40 CFR 721.10678.

PMN Number P-13-30

    Chemical name: Carboxylic acid, substituted alkylstannylene ester, 
reaction products with inorganic acid tetra alkyl ester (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an adhesive/sealant component. 
Based on test data on the PMN substance, EPA identified concerns for 
thymus toxicity to workers exposed to the PMN substance. As described 
in the PMN, adequate dermal protection is used and worker exposure will 
be minimal and there are no consumer exposures. 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 in consumer products or any use of 
the substance without the use of impervious gloves, when there is 
potential dermal exposure, may result in significant adverse human 
health effects. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(i).
    Recommended testing: EPA has determined that the results of a skin 
absorption: In vivo method test (OECD Test Guideline 427) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10679.

PMN Numbers P-13-44, P-13-46, P-13-47, P-13-50, and P-13-51

    Chemical names: Fatty acid amides (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the use of the substances 
will be as adhesive promoters for asphalt applications and emulsifiers 
for asphalt applications. Based on the EcoSAR analysis of test data on 
analogous aliphatic amines and amides, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb of the PMN 
substances respectively in surface waters for greater than 20 days per 
year. This 20-day criterion is derived from partial life cycle tests 
(daphnid chronic and fish early-life stage tests) that typically range 
from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the PMN substances to surface waters 
exceed releases from the uses described in the PMNs. For the use 
described in the PMNs, environmental releases did not exceed the 
respective concentrations of concern for more than 20 days per year. 
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 substances other than 
as an adhesive promoter for asphalt applications or as emulsifiers for 
asphalt applications, as described in the PMNs, could result in 
exposures which 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 a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed. Testing 
may be performed on any one of the PMN substances (P-13-44, P-13-46, P-
13-47, P-13-50, or P-13-51).
    CFR citation: 40 CFR 721.10680.

PMN Numbers P-13-55 and P-13-56

    Chemical names: Alkaneamide, halo-dialkylthienyl-alkoxydialkyl-, 
manuf. of by-products from (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs states that the generic (non-
confidential) use of the substances will be as starting material in 
sulfuric acid production. Based on EcoSAR analysis of test data on 
analogous haloacetamides, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 ppb of the PMN substances in 
surface waters. As described in the PMN, releases of the PMN substances 
are not expected to result in surface water concentrations exceeding 1 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of these substances may present an unreasonable 
risk. EPA has determined, however, that any use of these substances 
other than as stated in the PMN or use of the substances resulting in 
releases to surface water concentrations exceeding 1 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substances meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of an 
algal toxicity test (OCSPP Test Guideline 850.4500); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010); and a fish acute toxicity test, freshwater and 
marine (OPPTS Test Guideline 850.1075) would help characterize the 
environmental effects of the PMN substances.
    CFR citation: 40 CFR 721.10681.

PMN Numbers P-13-63, P-13-64, P-13-65, P-13-69, P-13-70, P-13-71, P-13-
72, P-13-73, P-13-74, P-13-75, P-13-76, and P-13-77

    Chemical names: Fatty acid amide hydrochlorides (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the substances will be used 
as

[[Page 48057]]

surfactants for asphalt emulsions. Based on the EcoSAR analysis of test 
data on analogous aliphatic amines and amides, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb (for P-
13-63 P-13-64, P-13-65, P-13-69, P-13-70, P-13-71 P-13-72, P-13-73, and 
P-13-74) and 2 ppb (for P-13-75, P-13-76, and P-13-77) of the PMN 
substances respectively in surface waters for greater than 20 days per 
year. This 20-day criterion is derived from partial life cycle tests 
(daphnid chronic and fish early-life stage tests) that typically range 
from 21 to 28 days in duration. EPA predicts toxicity to aquatic 
organisms may occur if releases of the PMN substances to surface water 
exceed releases from the use described in the PMNs. For the use 
described in the PMNs, environmental releases did not exceed the 
respective concentrations of concern for more than 20 days per year. 
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 substances other than as 
surfactants for use in asphalt emulsions, as described in the PMNs, 
could result in exposures which 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 a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed. Testing 
may be performed on any one of the PMN substances (P-13-63, P-13-64, P-
13-65, P-13-69, P-13-70, P-13-71, P-13-72, P-13-73, P-13-74, P-13-75, 
P-13-76, or P-13-77).
    CFR citation: 40 CFR 721.10682.

PMN Number P-13-131

    Chemical name: Dialkylamino cocoalkyl alkylamide acid salt 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as an inhibitor for oil field 
applications. Based on the EcoSAR analysis of test data on analogous 
amides and 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, releases of the PMN substance 
are not expected to result in surface water concentrations that exceed 
1 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in surface water concentrations exceeding 1 ppb may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OECD Test Guideline 301B), a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300), a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400), and an algal toxicity 
test (OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10683.

PMN Number P-13-135

    Chemical name: Substituted benzenamine schiff base (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance is 
as an intermediate monomer for use in the manufacture of another 
monomer. Based on the EcoSAR analysis of test data on analogous schiff 
bases, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the PMN substance to 
surface waters 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 resulting in surface water concentrations exceeding 1 
ppb may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of an 
algal toxicity test (OCSPP Test Guideline 850.4500); a daphnid chronic 
toxicity test (OPPTS Test Guideline 850.1300); a fish early-stage 
toxicity test (OPPTS Test Guideline 850.1400); a partition coefficient 
(n-octanol/water), estimation by liquid chromatography test (OPPTS Test 
Guideline 830.7570); a ready biodegradability test (OECD Test Guideline 
301); and a hydrolysis as a function of pH test (OPPTS Test Guideline 
835.2120) would help characterize the environmental effects of the PMN 
substance.
    CFR citation: 40 CFR 721.10684.

PMN Number P-13-170

    Chemical name: Phosphoric acid, mixed esters (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a plastic additive. 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. As described in the PMN, releases of the 
PMN substance are not expected to result in surface water 
concentrations that exceed 1 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in surface water concentrations 
exceeding 1 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) and a 
fish early-life stage toxicity test (OPPTS Test Guideline 850.1400) 
would help characterize the environmental effects of the PMN substance. 
EPA also recommends that the guidance document on aquatic toxicity 
testing of difficult substances and mixtures (OECD Test Guideline 23) 
be followed.
    CFR citation: 40 CFR 721.10685.

PMN Numbers P-13-180, P-13-181, P-13-182, P-13-183, P-13-184, and P-13-
185

    Chemical names: Fatty acid amides (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the use of the substances is 
as adhesive promoters for asphalt applications and emulsifiers for 
asphalt applications. Based on the EcoSAR analysis of test data on 
analogous aliphatic amines and amides, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb (for P-13-180, 
P-13-182, and P-13-185); 2 ppb (for P-13-181 and P-13-183); and 4 ppb 
(for P-13-184) of the PMN substances in surface waters for greater than 
20 days per year. This 20-day criterion is derived from partial life 
cycle tests (daphnid chronic and fish early-life stage tests) that 
typically range from 21

[[Page 48058]]

to 28 days in duration. EPA predicts toxicity to aquatic organisms may 
occur if releases of the PMN substances to surface water exceed 
releases from the use described in the PMNs. For the use described in 
the PMNs, environmental releases did not exceed the respective 
concentrations of concern for more than 20 days per year. 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 substances other than as adhesive 
promoters for asphalt applications or emulsifiers for asphalt 
applications, as described in the PMNs, could result in exposures which 
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 a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed. Testing 
may be performed on any one of the PMN substances (P-13-180, P-13-181, 
P-13-182, P-13-183, P-13-184, or P-13-185), however, it is recommended 
that it be conducted on P-13-182 as EPA predicts this substance to be 
most acutely toxic to aquatic organisms.
    CFR citation: 40 CFR 721.10686.

PMN Numbers P-13-201, P-13-203, P-13-204, P-13-205, P-13-206, P-13-207, 
P-13-208, and P-13-209

    Chemical names: Fatty acid amide hydrochlorides (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the use of the substances is 
as surfactants for asphalt emulsions. Based on the EcoSAR analysis of 
test data on analogous aliphatic amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb (for P-
13-204, P-13-206, and P-13-207); 2 ppb (for P-13-205); 3 ppb (for P-13-
209); 5 ppb (for P-13-201); 6 ppb (for P-13-208); and 12 ppb (for P-13-
203) of the PMN substances respectively in surface waters for greater 
than 20 days per year. This 20-day criterion is derived from partial 
life cycle tests (daphnid chronic and fish early-life stage tests) that 
typically range from 21 to 28 days in duration. EPA predicts toxicity 
to aquatic organisms may occur if releases of the PMN substances to 
surface waters exceed releases from the use described in the PMNs. For 
the use described in the PMNs, environmental releases did not exceed 
the respective surface water concentrations for more than 20 days per 
year. 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 other than as surfactants for asphalt emulsions could result 
in exposures which 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 a fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010); and an algal toxicity test 
(OCSPP Test Guideline 850.4500) would help characterize the 
environmental effects of the PMN substances. EPA also recommends that 
the guidance document on aquatic toxicity testing of difficult 
substances and mixtures (OECD Test Guideline 23) be followed. Testing 
may be performed on any one of the PMN substances (P-13-201, P-13-203, 
P-13-204, P-13-205, P-13-206, P-13-207, P-13-208, or P-13-209).
    CFR citation: 40 CFR 721.10687.

PMN Number P-13-221

    Chemical name: Copper, chloro[tris(2-chloroethyl) 
phosphite-.kappa.P]-.
    CAS number: 24484-01-3.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a manufacturing process 
aid. Also, EPA identified concerns for oncogenicity, mutagenicity, and 
developmental toxicity based on the alkylation potential of the PMN 
substance and concern for neurotoxicity and reproductive toxicity based 
on analog test data. There is also concern for immunotoxicity based on 
the presence of the copper ion. These concerns are for effects to 
workers from inhalation exposure to the PMN. Additionally, based on the 
EcoSAR analysis of test data on analogous organic copper compounds, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 6 ppb of the PMN substance in surface waters. As described in 
the PMN, significant workplace exposures are not expected and releases 
of the PMN substance are not expected to result in surface water 
concentrations that exceed 6 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that use 
of the substance other than as described in the PMN or any use of the 
substance resulting in surface water concentrations exceeding 6 ppb may 
cause serious health or significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that a carcinogenicity test 
(OPPTS Test Guideline 870.4200) in rats; an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS Test Guideline 850.1010); a 
fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075); and an algal toxicity test (OCSPP Test Guideline 850.4500) 
would help characterize the human health and environmental effects of 
the PMN substance. EPA recommends that the guidance document on aquatic 
toxicity testing of difficult substances and mixtures (OECD Test 
Guideline 23) be followed.
    CFR citation: 40 CFR 721.10688.

PMN Number P-13-225

    Chemical name: Organo zinc salts (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a stabilizer for 
thermoplastics. Based on the EcoSAR analysis of test data on analogous 
organic zinc compounds, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 3 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the substance are 
not expected to result in surface water concentrations that exceed 3 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
surface water concentrations exceeding 3 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300), a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400), and an 
algal

[[Page 48059]]

toxicity test (OCSPP Test Guideline 850.4500) would help characterize 
the environmental effects of the PMN substance.
    CFR citation: 40 CFR 721.10689.

PMN Number P-13-232

    Chemical name: Benzenedicarboxylic acid, polymer with substituted 
alkanediol, dodecanedioic acid, 1,2-ethanediol, alkanedioic acid, 
alkanediol,.alpha.-hydro-.omega.-hydroxypoly[oxyalkanediyl], 1,3-
isobenzofurandione, methylene diphenyl diisocyanate, 2-oxepanone, 2,2'-
oxybis[ethanol] and polymethylene polyphenylene isocyanate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial adhesive. 
Based on analogous diisocyanates, EPA identified concerns for 
sensitization as well as lung and mucous membrane irritation. For the 
use described in the PMN, EPA does not expect significant occupational 
or consumer inhalation exposure as the substance is not applied using a 
method that generates a vapor, mist, or aerosol or used in a consumer 
product. 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 in consumer products or any use of the substance involving an 
application method that generates a vapor, mist, or aerosol 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 skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10690.

PMN Number P-13-267

    Chemical name: Fatty acid amide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the use of the substance is 
as a polymer additive. Based on the EcoSAR analysis of test data on 
analogous amides, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 1 ppb of the PMN substance in surface 
waters. As described in the PMN, releases of the PMN substance to 
surface waters 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 resulting in surface water concentrations exceeding 1 
ppb may cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that an algal toxicity test 
(OCSPP Test Guideline 850.4500), a daphnid chronic toxicity test (OPPTS 
Test Guideline 850.1300); a fish early-life stage toxicity test (OPPTS 
Test Guideline 850.1400) and the shake flask die-away test (OPPTS Test 
Guideline 835.3170) would help characterize the environmental effects 
of the PMN substance. EPA recommends that the guidance document on 
aquatic toxicity testing of difficult substances and mixtures (OECD 
Test Guideline 23) be followed.
    CFR citation: 40 CFR 721.10691.

PMN Number P-13-288

    Chemical name: Fluorinated alkyl dianiline (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance is as a polymer precursor. EPA 
identified concern for acute toxicity based on test data on the PMN 
substance. Also, EPA identified concern for dermal sensitization and 
oncogenicity based on benzidines; concern for neurotoxicity based on 
aromatic amines; and concern for retinopathy based on dianiline 
compounds. The concern is for workers exposed to the PMN substance. For 
the industrial 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 PMN substance other than as an intermediate may result in 
serious health effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170 (b)(1)(i)(C), (b)(3)(i), 
and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a rat 
acute oral retinopathy screening study (protocol to be approved by EPA 
to include histopathological examination of the eyes by both light and 
electron microscopy) would help characterize the health effects of the 
PMN substance.
    CFR citation: 40 CFR 721.10692.

PMN Number P-13-338

    Chemical name: Diphenylmethane diisocyanate polymer with alkanoic 
diacid and alkanediol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a polymer intermediate 
for adhesive manufacture. Based on analogous diisocyanates, EPA 
identified concerns for dermal and respiratory sensitization, 
irritation, and lung effects. For the use described in the PMN, EPA 
does not expect significant occupational or consumer inhalation 
exposure as the substance is not applied using a method that generates 
a vapor, mist, or aerosol or used in a consumer product. 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 in consumer products or any use 
of the substance involving an application method that generates a 
vapor, mist, or aerosol 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 skin 
sensitization test (OPPTS Test Guideline 870.2600) and a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) would help 
characterize the human health effects of the PMN substance.
    CFR citation: 40 CFR 721.10693.

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 7 of the 53 
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.  14;721.160 (see Unit 
VI.).
    In the other 46 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

[[Page 48060]]

established at Sec.  14;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, 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, 
or processing a listed chemical substance for the described significant 
new use.
     EPA will be able to regulate prospective manufacturers 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 and processors of 
the same chemical substance that is subject to a TSCA section 5(e) 
consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Chemical Substance 
Inventory (TSCA Inventory). Guidance on how to determine if a chemical 
substance is on the TSCA Inventory is available on the Internet at 
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.

VI. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in 
Sec.  [emsp14]721.160(c)(3) and Sec.  [emsp14]721.170(d)(4). In 
accordance with Sec.  [emsp14]721.160(c)(3)(ii) and Sec.  
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is October 
7, 2013 without further notice, unless EPA receives written adverse or 
critical comments, or notice of intent to submit adverse or critical 
comments before September 6, 2013.
    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 September 6, 2013, 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 the Significant New Use Designation

    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. 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 person may commence such activities 
without first submitting a PMN. Therefore, for chemical substances for 
which an NOC has not been submitted EPA concludes that the designated 
significant new uses are not ongoing.
    When chemical substances identified in this rule are added to the 
TSCA Inventory, EPA recognizes that, before the rule is effective, 
other persons might engage in a use that has been identified as a 
significant new use. However, TSCA section 5(e) consent orders have 
been issued for 7 of the 53 chemical substances, and the PMN submitters 
are prohibited by the TSCA section 5(e) consent orders from undertaking 
activities which would be designated as significant new uses. The 
identities of 5 of the 53 chemical substances subject to this rule have 
been claimed as confidential and EPA has received no post-PMN bona fide 
submissions (per Sec. Sec.  720.25 and 721.11). Based on this, 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.
    Therefore EPA designates August 7, 2013 as the cutoff date for 
determining whether the new use is ongoing. Persons who begin 
commercial manufacture or processing of the chemical substances for a 
significant new use identified as of that date would have to cease any 
such activity upon the effective date of the final rule. To resume 
their activities, these persons would have to first comply with all 
applicable SNUR notification requirements and wait until the notice 
review period, including any extensions, expires. If such a person met 
the conditions of advance compliance under Sec.  721.45(h), the person 
would be considered exempt from the requirements of the SNUR. Consult 
the Federal Register document of April 24, 1990 for a more detailed 
discussion of the cutoff date for ongoing uses.

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. The two exceptions 
are:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)).
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).
    In the absence of a TSCA section 4 test rule or a TSCA section 
5(b)(4) listing covering the chemical substance, persons are required 
only to submit test data in their possession or control and to describe 
any other data known to or reasonably ascertainable by them (see 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-section 5(e) SNURs. Descriptions of tests are provided 
for informational purposes. EPA strongly encourages persons, before 
performing any testing, to consult with the Agency pertaining to 
protocol selection. To access the OCSPP test guidelines referenced in 
this document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.'' The Organisation for Economic 
Co-operation and Development (OECD) test guidelines are available from 
the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at 
http://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

[[Page 48061]]

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 or processing.
    The recommended tests specified in Unit IV. may not be the only 
means of addressing the potential risks of the chemical substance. 
However, submitting a SNUN without any test data may increase the 
likelihood that EPA will take action under TSCA section 5(e), 
particularly if satisfactory test results have not been obtained from a 
prior PMN or SNUN submitter. EPA recommends that potential SNUN 
submitters contact EPA early enough so that they will be able to 
conduct the appropriate tests.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs which provide detailed information on the following:
     Human exposure and environmental release that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

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, at 40 CFR 
721.1725(b)(1).
    Under these procedures a manufacturer or processor may request EPA 
to determine whether a proposed use would be a significant new use 
under the rule. The manufacturer or processor must show that it has a 
bona fide intent to manufacture or process the chemical substance and 
must identify the specific use for which it intends to manufacture or 
process the chemical substance. If EPA concludes that the person has 
shown a bona fide intent to manufacture 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 and processors can 
combine the bona fide submission under the procedure in Sec.  
14;721.1725(b)(1) with that under Sec.  14;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 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

    According to Sec.  721.1(c), persons submitting a SNUN must comply 
with the same notification requirements and EPA regulatory procedures 
as persons submitting a PMN, including submission of test data on 
health and environmental effects as described inSec.  720.50. SNUNs 
must be submitted on EPA Form No. 7710-25, generated using e-PMN 
software, and submitted to the Agency in accordance with the procedures 
set forth in Sec. Sec.  720.40 and 721.25. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

XI. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN 
requirements for potential manufacturers and processors of the chemical 
substances subject to this rule. EPA's complete economic analysis is 
available in the docket under docket ID number EPA-HQ-OPPT-2013-0399.

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 (PRA)

    According to PRA (44 U.S.C. 3501 et seq.), an agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information that requires OMB approval under PRA, unless 
it has been approved by OMB and displays a currently valid OMB control 
number. The OMB control numbers for EPA's regulations in title 40 of 
the CFR, after appearing in the Federal Register, are listed in 40 CFR 
part 9, and included on the related collection instrument or form, if 
applicable. EPA 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.

[[Page 48062]]

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or Tribal government 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 effect on 
small governments subject to the requirements of UMRA sections 202, 
203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

    This action 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 rule 
does not significantly nor 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 (NTTAA)

    In addition, since this action does not involve any technical 
standards, NTTAA 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

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 action 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: July 30, 2013.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    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. In Sec.  9.1, add the following sections in numerical order under 
the undesignated center heading ``Significant New Uses of Chemical 
Substances'' to read as follows:

Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                           OMB  control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                                * * * * *
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
------------------------------------------------------------------------
                                * * * * *
721.10671...............................................       2070-0012
721.10672...............................................       2070-0012
721.10673...............................................       2070-0012
721.10674...............................................       2070-0012
721.10675...............................................       2070-0012
721.10676...............................................       2070-0012
721.10677...............................................       2070-0012
721.10678...............................................       2070-0012
721.10679...............................................       2070-0012
721.10680...............................................       2070-0012
721.10681...............................................       2070-0012
721.10682...............................................       2070-0012
721.10683...............................................       2070-0012
721.10684...............................................       2070-0012
721.10685...............................................       2070-0012
721.10686...............................................       2070-0012
721.10687...............................................       2070-0012
721.10688...............................................       2070-0012
721.10689...............................................       2070-0012
721.10690...............................................       2070-0012
721.10691...............................................       2070-0012
721.10692...............................................       2070-0012
721.10693...............................................       2070-0012
 

[[Page 48063]]

 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

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

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

0
4. Add Sec.  [emsp14]721.10671 to subpart E to read as follows:

Sec.  [emsp14]721.10671  Multi-walled carbon nanotubes (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as multi-
walled carbon nanotubes (PMNs P-09-198 and P-09-199) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this rule do not 
apply to quantities of the PMN substances after they have been 
completely reacted (cured); embedded or incorporated into a polymer 
matrix that itself has been reacted (cured); or embedded in a permanent 
solid polymer form that is not intended to undergo further processing, 
except mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.  
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4) (National 
Institute of Occupational Safety and Health (NIOSH)-certified air-
purifying, tight-fitting full-face respirator equipped with N100 
filters), (a)(6)(i), and (c). When determining which persons are 
reasonably likely to be exposed as required for Sec.  721.63 (a)(1) and 
(a)(4), engineering control measures (e.g., enclosure or confinement of 
the operation, general and local ventilation) or administrative control 
measures (e.g., workplace policies and procedures) shall be considered 
and implemented to prevent exposure, where feasible.
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80 (f), (k), and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(b)(1) and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(ii) of 
this section.

0
5. Add Sec.  [emsp14]721.10672 to subpart E to read as follows:

Sec.  [emsp14]721.10672  Sodium olefin sulfonate derivative (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as sodium 
olefin sulfonate derivative (PMNs P-09-447 and P-09-448) are subject to 
reporting under this section for the significant new uses described in 
paragraph (a)(2) of this section. The requirements of this rule do not 
apply to quantities of the chemical substances after they have been 
completely reacted (cured) or partitioned into oil or petroleum streams 
following use as specific enhanced oil recovery applications that have 
been claimed confidential.
    (2) The significant new uses are:
    (i) Hazard communication program. Requirements as specified in 
Sec.  721.72 (a), (b), (c). (d), (e) (concentration set at 1.0 
percent), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5).
    (ii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80(k).
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=10).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable to 
manufacturers and processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(1) of 
this section.

0
6. Add Sec.  721.10673 to subpart E to read as follows:

Sec.  [emsp14]721.10673  Alkanes, C21-34--branched and linear, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C21-34--
branched and linear, chloro (PMN P-12-539; CAS No. 1417900-96-9) 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. A significant new use is manufacture of 
the PMN substance with greater than 1 weight percent (``wt%'') of 
chlorinated (``Cl'') paraffins with an alkyl chain <= 20 and Sec.  
721.80(r) (Testing phase 1 is reached at 1,200,000 kg for the aggregate 
of the PMN substances P-12-539, P-13-107, and P-13-109. Testing 
includes analysis for chain length and percent chlorination (for 
example by gas chromatography-mass spectrometry or high performance 
liquid chromatography-mass spectrometry). Present EPA with a 
certificate of analysis and all raw data for congener analysis on P-12-
539, P-13-107, and P-13-109. Testing phase 2a is reached at 14,100,000 
kg for the aggregate of the PMN substances P-12-539, P-13-107, and P-
13-109. Testing includes a modified semi-continuous activated sludge 
(SCAS) test or modified SCAS test for insoluble and volatile chemicals 
or Zahn Wellens test with analytical procedures capable of measuring 
individual congeners and degradation products over time on three 
chlorinated linear C21 paraffin fractions to represent each of the 40%, 
55%, and > 70% chlorine by weight, three chlorinated C26 linear 
paraffin fractions to represent each of the 40%, 55%, and > 70% 
chlorine by weight, three chlorinated linear paraffin fractions, whose 
chain length represents the central tendency of the congener 
distribution of the very long chain chlorinated paraffins (vLCCP) 
product as identified in testing phase 1, to represent each of the 40%, 
55%, and > 70% chlorine by weight. Testing phase 2b is reached at 
59,100,000 kg for the aggregate of the PMN substances P-12-539, P-13-
107, and P-13-109. Testing includes aerobic and anaerobic 
transformation in soil test with analytical procedures capable of 
measuring individual congeners and degradation products over time and 
bioaccumulation in sediment-dwelling benthic oligochaetes on three 
chlorinated linear C21 paraffin fractions to represent each of the 40%, 
55%, and > 70% chlorine by weight, three chlorinated C26 linear 
paraffin fractions to represent each of the 40%, 55%, and > 70% 
chlorine by weight, three chlorinated linear paraffin fractions, whose 
chain length represents the central tendency of the congener 
distribution of the vLCCP product as identified in testing phase 1, to 
represent each of the 40%, 55%, and

[[Page 48064]]

 > 70% chlorine by weight. Testing phase 3 is reached at 78,400,000 kg 
for the aggregate of the PMN substances P-12-539, P-13-107, and P-13-
109. If the degradation half-life of the test substance is 28 days or 
shorter from testing phase 2a the sediment-water chironomid life-cycle 
toxicity test using spiked water or spiked sediment is an acceptable 
test, otherwise sediment-water lumbriculus toxicity test using spiked 
sediment is an acceptable test for any of the parent substances that 
are absorbed by the benthic oligochaetes in the bioaccumulation in 
sediment-dwelling benthic oligochaetes test. In the bioaccumulation in 
sediment-dwelling benthic oligochaetes test, use as test material any 
of the degradation products in testing phases 2a or 2b that are 
identified to potentially present an unreasonable risk or to further 
degrade to generate a substance of potential concern. Testing phase 4 
is reached at 86,100,000 kg for the aggregate of the PMN substances P-
12-539, P-13-107, and P-13-109. If the degradation half-life of the 
test substance is 28 days or shorter from testing phase 3 the sediment-
water chironomid life-cycle toxicity test using spiked water or spiked 
sediment is an acceptable test, otherwise the sediment-water 
lumbriculus toxicity test using spiked sediment is an acceptable test. 
Use degradation substances in testing phase 3 that are absorbed by the 
benthic oligochaetes as the test material.)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
7. Add Sec.  [emsp14]721.10674 to subpart E to read as follows:

Sec.  [emsp14]721.10674  Alkanes, C22-30--branched and linear, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C22-30--
branched and linear, chloro (PMN P-13-107; CAS No. 1401947-24-0) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec.  721.80. A significant new use is manufacture of 
the PMN substance with greater than 1 weight percent (``wt%'') of 
chlorinated (``Cl'') paraffins with an alkyl chain <= 20 and Sec.  
721.80(r) (Testing phase 1 is reached at 1,200,000 kg for the aggregate 
of the PMN substances P-12-539, P-13-107, and P-13-109. Testing 
includes analysis for chain length and percent chlorination (for 
example by gas chromatography-mass spectrometry or high performance 
liquid chromatography-mass spectrometry). Present EPA with a 
certificate of analysis and all raw data for congener analysis on P-12-
539, P-13-107, and P-13-109. Testing phase 2a is reached at 14,100,000 
kg for the aggregate of the PMN substances P-12-539, P-13-107, and P-
13-109. Testing includes a modified semi-continuous activated sludge 
(SCAS) test or modified SCAS test for insoluble and volatile chemicals 
or Zahn Wellens test with analytical procedures capable of measuring 
individual congeners and degradation products over time on three 
chlorinated linear C21 paraffin fractions to represent each of the 40%, 
55%, and > 70% chlorine by weight, three chlorinated C26 linear 
paraffin fractions to represent each of the 40%, 55%, and > 70% 
chlorine by weight, three chlorinated linear paraffin fractions, whose 
chain length represents the central tendency of the congener 
distribution of the very long chain chlorinated paraffins (vLCCP) 
product as identified in testing phase 1, to represent each of the 40%, 
55%, and > 70% chlorine by weight. Testing phase 2b is reached at 
59,100,000 kg for the aggregate of the PMN substances P-12-539, P-13-
107, and P-13-109. Testing includes aerobic and anaerobic 
transformation in soil test with analytical procedures capable of 
measuring individual congeners and degradation products over time and 
bioaccumulation in sediment-dwelling benthic oligochaetes on three 
chlorinated linear C21 paraffin fractions to represent each of the 40%, 
55%, and > 70% chlorine by weight, three chlorinated C26 linear 
paraffin fractions to represent each of the 40%, 55%, and > 70% 
chlorine by weight, three chlorinated linear paraffin fractions, whose 
chain length represents the central tendency of the congener 
distribution of the vLCCP product as identified in testing phase 1, to 
represent each of the 40%, 55%, and > 70% chlorine by weight. Testing 
phase 3 is reached at 78,400,000 kg for the aggregate of the PMN 
substances P-12-539, P-13-107, and P-13-109. If the degradation half-
life of the test substance is 28 days or shorter from testing phase 2a 
the sediment-water chironomid life-cycle toxicity test using spiked 
water or spiked sediment is an acceptable test, otherwise sediment-
water lumbriculus toxicity test using spiked sediment is an acceptable 
test for any of the parent substances that are absorbed by the benthic 
oligochaetes in the bioaccumulation in sediment-dwelling benthic 
oligochaetes test. In the bioaccumulation in sediment-dwelling benthic 
oligochaetes test, use as test material any of the degradation products 
in testing phases 2a or 2b that are identified to potentially present 
an unreasonable risk or to further degrade to generate a substance of 
potential concern. Testing phase 4 is reached at 86,100,000 kg for the 
aggregate of the PMN substances P-12-539, P-13-107, and P-13-109. If 
the degradation half-life of the test substance is 28 days or shorter 
from testing phase 3 the sediment-water chironomid life-cycle toxicity 
test using spiked water or spiked sediment is an acceptable test, 
otherwise the sediment-water lumbriculus toxicity test using spiked 
sediment is an acceptable test. Use degradation substances in testing 
phase 3 that are absorbed by the benthic oligochaetes as the test 
material.)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
8. Add Sec.  [emsp14]721.10675 to subpart E to read as follows:

Sec.  [emsp14]721.10675  Alkanes, C24-28, chloro.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as alkanes, C24-28, 
chloro (PMN P-13-109; CAS No. 1402738-52-6) 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. A significant new use is manufacture of 
the PMN substance with greater than 1 weight percent (``wt%'') of 
chlorinated (``Cl'') paraffins with an alkyl chain <= 20 and Sec.  
721.80(r) (Testing phase 1 is reached at 1,200,000 kg for the aggregate 
of the

[[Page 48065]]

PMN substances P-12-539, P-13-107, and P-13-109. Testing includes 
analysis for chain length and percent chlorination (for example by gas 
chromatography-mass spectrometry or high performance liquid 
chromatography-mass spectrometry). Present EPA with a certificate of 
analysis and all raw data for congener analysis on P-12-539, P-13-107, 
and P-13-109. Testing phase 2a is reached at 14,100,000 kg for the 
aggregate of the PMN substances P-12-539, P-13-107, and P-13-109. 
Testing includes a modified semi-continuous activated sludge (SCAS) 
test or modified SCAS test for insoluble and volatile chemicals or Zahn 
Wellens test with analytical procedures capable of measuring individual 
congeners and degradation products over time on three chlorinated 
linear C21 paraffin fractions to represent each of the 40%, 55%, and > 
70% chlorine by weight, three chlorinated C26 linear paraffin fractions 
to represent each of the 40%, 55%, and > 70% chlorine by weight, three 
chlorinated linear paraffin fractions, whose chain length represents 
the central tendency of the congener distribution of the very long 
chain chlorinated paraffins (vLCCP) product as identified in testing 
phase 1, to represent each of the 40%, 55%, and > 70% chlorine by 
weight. Testing phase 2b is reached at 59,100,000 kg for the aggregate 
of the PMN substances P-12-539, P-13-107, and P-13-109. Testing 
includes aerobic and anaerobic transformation in soil test with 
analytical procedures capable of measuring individual congeners and 
degradation products over time and bioaccumulation in sediment-dwelling 
benthic oligochaetes on three chlorinated linear C21 paraffin fractions 
to represent each of the 40%, 55%, and > 70% chlorine by weight, three 
chlorinated C26 linear paraffin fractions to represent each of the 40%, 
55%, and > 70% chlorine by weight, three chlorinated linear paraffin 
fractions, whose chain length represents the central tendency of the 
congener distribution of the vLCCP product as identified in testing 
phase 1, to represent each of the 40%, 55%, and > 70% chlorine by 
weight. Testing phase 3 is reached at 78,400,000 kg for the aggregate 
of the PMN substances P-12-539, P-13-107, and P-13-109. If the 
degradation half-life of the test substance is 28 days or shorter from 
testing phase 2a the sediment-water chironomid life-cycle toxicity test 
using spiked water or spiked sediment is an acceptable test, otherwise 
sediment-water lumbriculus toxicity test using spiked sediment is an 
acceptable test for any of the parent substances that are absorbed by 
the benthic oligochaetes in the bioaccumulation in sediment-dwelling 
benthic oligochaetes test. In the bioaccumulation in sediment-dwelling 
benthic oligochaetes test, use as test material any of the degradation 
products in testing phases 2a or 2b that are identified to potentially 
present an unreasonable risk or to further degrade to generate a 
substance of potential concern. Testing phase 4 is reached at 
86,100,000 kg for the aggregate of the PMN substances P-12-539, P-13-
107, and P-13-109. If the degradation half-life of the test substance 
is 28 days or shorter from testing phase 3 the sediment-water 
chironomid life-cycle toxicity test using spiked water or spiked 
sediment is an acceptable test, otherwise the sediment-water 
lumbriculus toxicity test using spiked sediment is an acceptable test. 
Use degradation substances in testing phase 3 that are absorbed by the 
benthic oligochaetes as the test material.)
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
9. Add Sec.  [emsp14]721.10676 to subpart E to read as follows:

Sec.  [emsp14]721.10676  Aromatic hydrocarbon mixture (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
aromatic hydrocarbon mixture (PMN P-12-551) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=78).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
10. Add Sec.  [emsp14]721.10677 to subpart E to read as follows:

Sec.  [emsp14]721.10677  Alkyl phosphonate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as alkyl 
phosphonate (PMN P-12-584) 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(g).
    (ii) Protection in the workplace. Requirements as specified in 
Sec.  721.63 (a)(1), (a)(2)(i), and (a)(3). When determining which 
persons are reasonably likely to be exposed as required for Sec.  
721.63 (a)(1) and (a)(4), engineering control measures (e.g., enclosure 
or confinement of the operation, general and local ventilation) or 
administrative control measures (e.g., workplace policies and 
procedures) shall be considered and implemented to prevent exposure, 
where feasible.
    (iii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to 
manufacturers and processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
11. Add Sec.  [emsp14]721.10678 to subpart E to read as follows:

Sec.  [emsp14]721.10678  1,4-Cyclohexanedicarboxylic acid, 1,4-dimethyl 
ester, hydrogenolysis products.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as 1,4-
cyclohexanedicarboxylic acid, 1,4-dimethyl ester, hydrogenolysis 
products (PMN P-13-10; CAS No. 1373220-73-5) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=20).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part

[[Page 48066]]

apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
12. Add Sec.  [emsp14]721.10679 to subpart E to read as follows:

Sec.  [emsp14]721.10679  Carboxylic acid, substituted alkylstannylene 
ester, reaction products with inorganic acid tetra alkyl ester 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
carboxylic acid, substituted alkylstannylene ester, reaction products 
with inorganic acid tetra alkyl ester (PMN P-13-30) 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(o).
    (ii) Protection in the workplace. Requirements as specified in 
Sec.  721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 
1.0%), and (c). When determining which persons are reasonably likely to 
be exposed as required for Sec.  721.63 (a)(1) and (a)(4), engineering 
control measures (e.g., enclosure or confinement of the operation, 
general and local ventilation) or administrative control measures 
(e.g., workplace policies and procedures) shall be considered and 
implemented to prevent exposure, where feasible.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (d), and (e) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
13. Add Sec.  [emsp14]721.10680 to subpart E to read as follows:

Sec.  [emsp14]721.10680  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amides (PMNs P-13-44, P-13-46, P-13-47, P-13-50, and P-13-51) are 
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. A significant new use is any use other 
than as adhesion promoters for asphalt applications or emulsifiers for 
asphalt applications.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
14. Add Sec.  [emsp14]721.10681 to subpart E to read as follows:

Sec.  [emsp14]721.10681  Alkaneamide, halo-dialkylthienyl-
alkoxydialkyl-, manuf. of by-products from (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as 
alkaneamide, halo-dialkylthienyl-alkoxydialkyl-, manuf. of by-products 
from (PMNs P-13-55 and PMN P-13-56) are 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(j).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (i) and (k) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
15. Add Sec.  [emsp14]721.10682 to subpart E to read as follows:

Sec.  [emsp14]721.10682  Fatty acid amide hydrochlorides (generic).

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide hydrochlorides (PMNs P-13-63, P-13-64, P-13-65, P-13-69, P-
13-70, P-13-71, P-13-72, P-13-73, P-13-74, P-13-75, P-13-76, and P-13-
77) are 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. A significant new use is any use other 
than as surfactants for use in asphalt emulsions.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
16. Add Sec.  [emsp14]721.10683 to subpart E to read as follows:

Sec.  [emsp14]721.10683  Dialkylamino cocoalkyl alkylamide acid salt 
(generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
dialkylamino cocoalkyl alkylamide acid salt (PMN P-13-131) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
17. Add Sec.  [emsp14]721.10684 to subpart E to read as follows:

[[Page 48067]]

Sec.  [emsp14]721.10684  Substituted benzenamine schiff base (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
substituted benzenamine schiff base (PMN P-13-135) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
18. Add Sec.  [emsp14]721.10685 to subpart E to read as follows:

Sec.  [emsp14]721.10685  Phosphoric acid, mixed esters (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
phosphoric acid, mixed esters (PMN P-13-170) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
19. Add Sec.  [emsp14]721.10686 to subpart E to read as follows:

Sec.  [emsp14]721.10686  Fatty acid amides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amides (PMNs P-13-180, P-13-181, P-13-182, P-13-183, P-13-184, and 
P-13-185) are 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. A significant new use is any use other 
than as adhesion promoters for asphalt applications or emulsifiers for 
asphalt applications.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
20. Add Sec.  [emsp14]721.10687 to subpart E to read as follows:

Sec.  [emsp14]721.10687  Fatty acid amide hydrochlorides (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substances identified generically as fatty 
acid amide hydrochlorides (PMNs P-13-201, P-13-203, P-13-204, P-13-205, 
P-13-206, P-13-207, P-13-208, and P-13-209) are 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. A significant new use is any use other 
than as surfactants for asphalt emulsions.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of these substances.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
21. Add Sec.  [emsp14]721.10688 to subpart E to read as follows:

Sec.  [emsp14]721.10688  Copper, chloro[tris(2-chloroethyl) 
phosphite-.kappa.P]-.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified as copper, 
chloro[tris(2-chloroethyl) phosphite-.kappa.P]- (PMN P-13-221; CAS No. 
24484-01-3) 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(j).
    (ii) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=6).
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

0
22. Add Sec.  [emsp14]721.10689 to subpart E to read as follows:

Sec.  [emsp14]721.10689  Organo zinc salts (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as organo 
zinc salts (PMN P-13-225) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=3).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
23. Add Sec.  [emsp14]721.10690 to subpart E to read as follows:

[[Page 48068]]

Sec.  [emsp14]721.10690  Benzenedicarboxylic acid, polymer with 
substituted alkanediol, dodecanedioic acid, 1,2-ethanediol, alkanedioic 
acid, alkanediol,.alpha.-hydro-.omega.-hydroxypoly[oxyalkanediyl], 1,3-
isobenzofurandione, methylene diphenyl diisocyanate, 2-oxepanone, 2,2'-
oxybis[ethanol] and polymethylene polyphenylene isocyanate (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
benzenedicarboxylic acid, polymer with substituted alkanediol, 
dodecanedioic acid, 1,2-ethanediol, alkanedioic acid, 
alkanediol,.alpha.-hydro-.omega.-hydroxypoly[oxyalkanediyl], 1,3-
isobenzofurandione, methylene diphenyl diisocyanate, 2-oxepanone, 2,2'-
oxybis[ethanol] and polymethylene polyphenylene isocyanate (PMN P-13-
232) 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 (o) and (y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
24. Add Sec.  [emsp14]721.10691 to subpart E to read as follows:

Sec.  [emsp14]721.10691  Fatty acid amide (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as fatty 
acid amide (PMN P-13-267) 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) Release to water. Requirements as specified in Sec.  721.90 
(a)(4), (b)(4), and (c)(4) (N=1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (k) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
25. Add Sec.  [emsp14]721.10692 to subpart E to read as follows:

Sec.  [emsp14]721.10692  Fluorinated alkyl dianiline (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
fluorinated alkyl dianiline (PMN P-13-288) 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(g).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

0
26. Add Sec.  [emsp14]721.10693 to subpart E to read as follows:

Sec.  [emsp14]721.10693  Diphenylmethane diisocyanate polymer with 
alkanoic diacid and alkanediol (generic).

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance identified generically as 
diphenylmethane diisocyanate polymer with alkanoic diacid and 
alkanediol (PMN P-13-338) 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 (o) and (y)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), (c), and (i) are applicable to manufacturers and 
processors of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec.  721.185 apply to this section.

[FR Doc. 2013-18982 Filed 8-6-13; 8:45 am]
BILLING CODE 6560-50-P