Significant New Use Rules on Certain Chemical Substances, 57169-57186 [2010-23415]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 181 (Monday, September 20, 2010)]
[Rules and Regulations]
[Pages 57169-57186]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-23415]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2009-922; FRL-8839-7]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 25 
chemical substances which were the subject of premanufacture notices 
(PMNs). One of these chemical substances is subject to a TSCA section 
5(e) consent order issued by EPA. This action requires persons who 
intend to manufacture, import, or process any of these 25 chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. The required notification will provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: This rule is effective on November 19, 2010. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on 
October 4, 2010.
    Written adverse or critical comments, or notice of intent to submit 
adverse or critical comments, on one or more of these SNURs must be 
received on or before October 20, 2010 (see Unit VI. of the 
SUPPLEMENTARY INFORMATION).
    For additional information on related reporting requirement dates, 
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2009-922, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 
Docket ID Number EPA-HQ-OPPT-2009-922. The DCO is open from 8 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-922. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in

[[Page 57170]]

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; e-mail 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; e-mail address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127; 
see also 19 CFR 127.28. Chemical importers must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA. Importers of 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 this rule on or after October 
20, 2010 are subject to the export notification provisions of TSCA 
section 12(b) (15 U.S.C. 2611(b)) (see Sec.  721.20), and must comply 
with the export notification requirements in 40 CFR part 707, subpart 
D.

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

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

II. Background

A. What Action is the Agency Taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture, import, or processing of a chemical 
substance for any activity designated by these SNURs as a significant 
new use. Receipt of such notices allows EPA to assess risks that may be 
presented by the intended uses and, if appropriate, to regulate the 
proposed use before it occurs. Additional rationale and background to 
these rules are more fully set out in the preamble to EPA's first 
direct final SNUR published in the Federal Register of April 24, 1990 
(55 FR 17376). Consult that preamble for further information on the 
objectives, rationale, and procedures for SNURs and on the basis for 
significant new use designations, including provisions for developing 
test data.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2) (see 
Unit III.). Once EPA determines that a use of a chemical substance is a 
significant new use, TSCA section 5(a)(1)(B) requires persons to submit 
a significant new use notice (SNUN) to EPA at least 90 days before they 
manufacture, import, or process the chemical substance for that use. 
The mechanism for reporting under this requirement is established under 
Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees

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appear at 40 CFR part 700. According to Sec.  721.1(c), persons subject 
to these SNURs must comply with the same notice requirements and EPA 
regulatory procedures as submitters of PMNs under TSCA section 
5(a)(1)(A). In particular, these requirements include the information 
submission requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, 
or 7 to control the activities for which it has received the SNUN. If 
EPA does not take action, EPA is required under TSCA section 5(g) to 
explain in the Federal Register its reasons for not taking action.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C. 
2612) import certification requirements promulgated at 19 CFR 12.118 
through 12.127; see also 19 CFR 127.28. Chemical importers must certify 
that the shipment of the chemical substance complies with all 
applicable rules and orders under TSCA. Importers of 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 identified in 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.

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 
25 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 25 chemical substances in 40 CFR part 721, subpart E. 
In this unit, EPA provides the following information for each chemical 
substance:
     PMN number.
     Chemical name (generic name, if the specific name is 
claimed as CBI).
     CAS number (if assigned for non-confidential chemical 
identities).
     Basis for the TSCA section 5(e) consent order or, for non-
section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA 
section 5(e) consent orders).
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VIII. for more 
information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The regulatory text section of this rule specifies the activities 
designated as significant new uses. Certain new uses, including 
production volume limits (i.e., limits on manufacture and importation 
volume) and other uses designated in this rule, may be claimed as CBI. 
Unit IX. discusses a procedure companies may use to ascertain whether a 
proposed use constitutes a significant new use.
    This rule includes one PMN substance (P-04-269) that is subject to 
a ``risk-based'' consent order under TSCA section 5(e)(1)(A)(ii)(I) 
where EPA determined that activities associated with the PMN substance 
may present unreasonable risk to human health and the environment. The 
consent order requires protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNUR'' on this PMN substance is promulgated pursuant to Sec.  
721.160, and is based on and consistent with the provisions in the 
underlying consent order. The 5(e) SNUR designates as a ``significant 
new use'' the absence of the protective measures required in the 
corresponding consent order.
    Where EPA determined that the PMN substance may present an 
unreasonable risk of injury to human health via inhalation exposure, 
the underlying TSCA section 5(e) consent order usually requires, among 
other things, that potentially exposed employees wear specified 
respirators unless actual measurements of the workplace air show that 
air-borne concentrations of the PMN substance are below a New Chemical 
Exposure Limit (NCEL) that is established by EPA to provide adequate 
protection to human health. In addition to the actual NCEL 
concentration, the comprehensive NCELs provisions in TSCA section 5(e) 
consent orders, which are modeled after Occupational Safety and Health 
Administration (OSHA) Permissible Exposure Limits (PELs) provisions, 
include requirements addressing performance criteria for sampling and 
analytical methods, periodic monitoring, respiratory protection, and 
recordkeeping. However, no comparable NCEL provisions currently exist 
in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, 
the individual SNURs in 40 CFR part 721, subpart E, will state that 
persons subject to the SNUR who wish to pursue NCELs as an alternative 
to the Sec.  721.63 respirator requirements may request to do so under 
Sec.  721.30. EPA expects that persons whose Sec.  721.30 requests to 
use the NCELs approach for SNURs are approved by EPA will be required 
to comply with NCELs provisions that are comparable to those contained 
in the corresponding TSCA section 5(e) consent order for the same 
chemical substance.
    This rule also includes SNURs on 24 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). However, EPA does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-5(e) SNURs issued under Sec.  721.170 satisfies the two 
requirements stipulated in Sec.  721.170(c)(2), i.e., these significant 
new use activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental

[[Page 57172]]

concerns identified'' for the PMN substance.

PMN Number P-04-269
Chemical name: Cobalt lithium manganese nickel oxide.
CAS number: 182442-95-1.
Effective date of TSCA section 5(e) consent order: May 12, 2009.
Basis for TSCA section 5(e) consent order: The PMN states that the 
substance will be used as a battery cathode material. The order was 
issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based 
on findings that this substance may present an unreasonable risk of 
injury to human health and the environment. To protect against these 
risks, the consent order requires use of dermal personal protective 
equipment, including gloves demonstrated to be impervious, use of 
respiratory personal protective equipment, including a National 
Institute of Occupational Safety and Health (NIOSH)-approved respirator 
with an assigned protection factor (APF) of at least 150 or compliance 
with a NCEL of 0.1 mg/m\3\ as an 8-hour time-weighted average, 
establishment of a hazard communication program, and prohibits releases 
to water. The SNUR designates as a ``significant new use'' the absence 
of these protective measures.
Toxicity concern: Based on test data on nickel, lithium and cobalt, EPA 
has concerns for developmental toxicity, mutagenicity, oncogenicity, 
pulmonary oncogenicity, and lung overload for workers with inhalation 
and dermal exposure to the PMN substance. EPA set the NCEL at 0.1 mg/
m\3\ as an 8-hour time-weighted average. In addition, based on test 
data on analogous nickel containing compounds, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 part per 
billion (ppb) of the PMN substance in surface waters.
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the human health and 
environmental effects of the PMN substance: A 90-day inhalation 
toxicity test (OPPTS Test Guideline 870.3465); 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, tiers I and II (OPPTS 
Test Guideline 850.5400). All aquatic toxicity testing should be 
performed using the static method with measured concentrations. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results. The order does 
not require submission of the aforementioned information at any 
specified time or production volume. However, the order's restrictions 
on manufacturing, import, processing, distribution in commerce, use, 
and disposal of the PMN substance will remain in effect until the order 
is modified or revoked by EPA based on submission of that or other 
relevant information.

CFR citation: 40 CFR 721.10201.
PMN Number P-08-701
Chemical name: Benzoic acid, 4-chloro-2- [(substituted)azo]-, strontium 
salt (1:1) (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a pigment for plastics. Based on test 
data on analogous substances, EPA has concerns for oncogenicity, 
developmental toxicity, and blood and spleen effects from exposure to 
the azo reduction products of the PMN substance via inhalation. Since 
significant worker exposure is unlikely for the uses described in the 
PMN, 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 may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that results from the following 
tests would help characterize the human health effects of the PMN 
substance: A bacterial reverse mutation test (OPPTS Test Guideline 
870.5100) with prival modification, and an unscheduled DNA synthesis in 
mammalian cells in culture test (OPPTS Test Guideline 870.5550) for the 
azo reduction product of the PMN substance. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10202.
PMN Number P-08-742
Chemical name: Phosphonium, tetrabutyl-, hydroxide (1:1).
CAS number: 14518-69-5.
Basis for action: The PMN states that the substance will be used as a 
chemical intermediate for manufacturing tetrabutylphosphonium salt, as 
an export for industrial use, and additional confidential chemical 
intermediate uses. 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, the substance is not released to surface waters. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance resulting in release 
to surface waters may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300); and an algal toxicity test, tiers I and II (OPPTS 
Test Guideline 850.5400). Fish and daphnid testing should be performed 
using the flow-through method with measured concentrations. Algal 
testing should be performed using the static method with measured 
concentrations. Test reports should include protocols approved by EPA, 
certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10203.
PMN Number P-08-754
Chemical name: Aryloxyacrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a monomer. Based on ecological 
structural activity relationship (EcoSAR) analysis of test data on 
analogous acrylates, 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 PMN 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 results of the following 
tests would help characterize the environmental effects of the PMN 
substance: A fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075) using the flow-

[[Page 57173]]

through method with measured concentrations; an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS Test Guideline 
850.1010) using the flow-through method with measured concentrations; 
and an algal toxicity test, tiers I and II (OPPTS Test Guideline 
850.5400) using the static method with measured concentrations. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10204.
PMN Number P-09-4
Chemical name: Formaldehyde, polymer with 1,3-benzenediol and 1,1'-
methylenebis[isocyanatobenzene].
CAS number: 1067881-45-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a rubber additive. Based on EcoSAR 
analysis of test data on analogous esters and polyphenols, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance will not be released to surface waters. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in release to surface 
waters may cause significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that results of the following 
tests would help characterize the environmental effects of the PMN 
substance: A fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075) using the flow-through method with mean 
measured concentrations; an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity 
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static 
method with mean measured concentrations. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10205.
PMN Number P-09-19
Chemical name: 4-Cyclohexene-1,2-dicarboxylic acid, 1,2-bis(2-
oxiranylmethyl) ester.
CAS number: 21544-03-6.
Basis for action: The PMN states that the substance will be used as an 
epoxy resin for filament winding and electrical encapsulation of motors 
and generators. Based on test data on analogous esters and epoxides, 
EPA identified concerns for lung and dermal sensitization, 
mutagenicity, oncogenicity, male reproductive toxicity, liver and 
kidney toxicity, and eye corrosion to workers exposed to the PMN 
substance. As described in the PMN, worker inhalation exposure is 
expected to be negligible and dermal exposure is expected to be minimal 
due to the use of adequate personal protective equipment. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that use of the substance without the use of 
dermal protection where there is potential for dermal exposure, or 
without the appropriate hazard communication 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) and (b)(3)(ii).
Recommended testing: EPA has determined that results of the following 
tests would help characterize the human health effects of the PMN 
substance: A 90-day dermal toxicity study (OPPTS Test Guideline 
870.3250) with attention to the pathology of the reproductive organs 
and a carcinogenicity study (OPPTS Test Guideline 870.4200). Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10206.
PMN Number P-09-38
Chemical name: 1,3-Cyclohexanedimethanamine, N1,N3-bis(2-
methylpropylidene)-.
CAS number: 173904-11-5.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a curing agent for polyurethane 
systems. Based on EcoSAR analysis of test data on analogous Schiff 
bases 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, the substance is not expected 
to be released to surface waters. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in release to surface waters may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that results of the following 
tests would help characterize the environmental effects of the PMN 
substance: A water solubility: column elution method; shake flask 
method (OPPTS Test Guideline 830.7840); a fish acute toxicity test, 
freshwater and marine (OPPTS Test Guideline 850.1075) using the flow-
through method with mean measured concentrations; an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS Test 
Guideline 850.1010) using the flow-through method with mean measured 
concentrations; and an algal toxicity test, tiers I and II (OPPTS Test 
Guideline 850.5400) using the static method and mean measured 
concentrations. Test reports should include protocols approved by EPA, 
certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10207.
PMN Number P-09-71
Chemical name: Amines, di-C11-14-isoalkyl, C13-rich.
CAS number: 1005516-89-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. Based on 
EcoSAR analysis of test data on analogous aliphatic amines, EPA 
predicts that toxicity to aquatic organisms may occur at concentrations 
that exceed 2 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 2 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 2 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 the following 
tests would help characterize the environmental effects of the PMN 
substance: A fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075) using the flow-through method with mean 
measured concentrations or a fish acute toxicity mitigated by humic 
acid (OPPTS Test Guideline 850.1085) using the flow-through method with 
measured concentrations; an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean

[[Page 57174]]

measured concentrations; and an algal toxicity test, tiers I and II 
(OPPTS Test Guideline 850.5400) using the static method with mean 
measured concentrations. Test reports should include protocols approved 
by EPA, certificate of analysis for the test substance, raw data, and 
results.

CFR citation: 40 CFR 721.10208.
PMN Number P-09-120
Chemical name: Epoxy terminated, hydrolyzed trialkoxysilane and 
glycidyl ether of phenol-formaldehyde resin (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
polymerizable component of adhesive formulations. Based on EcoSAR 
analysis of test data on analogous alkoxysilanes and polyepoxides, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 81 ppb of the PMN substance in surface waters. As described in 
the PMN, the substance is not expected to be released to surface 
waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075) using the flow-through method with mean 
measured concentrations; an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity 
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static 
method with mean measured concentrations. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10209.
PMN Number P-09-130
Chemical name: Soybean oil, epoxidized, reaction products with 
diethanolamine.
CAS number: 1002761-12-7.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a polyol for flexible and rigid 
polyurethane foam applications. Based on EcoSAR analysis of test data 
on analogous aliphatic amines, 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, the substance 
will not be released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in release to surface 
waters may cause significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A ready biodegradability test (OPPTS Test Guideline 
835.3110); a fish acute toxicity test, freshwater and marine (OPPTS 
Test Guideline 850.1075) using the flow-through method with mean 
measured concentrations; an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS Test Guideline 850.1010) using the flow-
through method with mean measured concentrations; and an algal toxicity 
test, tiers I and II (OPPTS Test Guideline 850.5400) using the static 
method with mean measured concentrations. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10210.
PMN Number P-09-172
Chemical name: Octadecanoic acid, reaction products with 
diethylenetriamine and urea, acetates.
CAS number: 84962-05-0.
Basis for action: The PMN states that the substance will be used as a 
softener padded on cotton fabrics. Based on EcoSAR analysis of test 
data on analogous aliphatic amines, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 1 ppb of the PMN 
substance in surface waters. For the annual manufacture and import 
volume described in the PMN, the substance is not expected to be 
released to water. 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 exceedance of the 
annual maximum manufacture and import limit of 10,000 kilograms, could 
result in releases to water, which may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
followings tests would help characterize the environmental effects of 
the PMN substance: 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, tiers I and II (OPPTS Test Guideline 850.5400). Fish and 
daphnid testing should be performed using the flow-through method with 
mean measured concentrations. Algal testing should be formed using the 
static method with mean measured concentrations. Test reports should 
include protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10211.
PMN Number P-09-241
Chemical name: 1,2-Ethanediol, reaction products with epichlorohydrin.
CAS number: 705265-31-2.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an industrial reactant. Based on test 
data on analogous epoxides, EPA identified the following toxicity 
concerns from exposure to the PMN substance: Irritation and 
sensitization to eyes, skin, and lungs; mutagenicity; oncogenicity; and 
developmental, liver, kidney, and male reproductive toxicity. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii). At the production volume stated in the PMN, worker 
exposure and general population exposure are limited. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk under TSCA section 
5(e). However, EPA has determined in accordance with TSCA section 
5(a)(2)(A) and (C) and 40 CFR 721.170(a), that exceedance of the annual 
maximum manufacture and import limit of 100,000 kilograms may result in 
significant human exposures or environmental release.
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the human health effects of the 
PMN substance: Aerobic mineralization in surface water - simulation 
biodegradation test (Organisation for Economic Co-operation and 
Development (OECD) 309 test guideline) using the receiving water where 
the discharge will occur; an acute oral toxicity test (OPPTS Test 
Guideline 870.1100 or OECD 425 test guideline); a bacterial reverse 
mutation test (OPPTS

[[Page 57175]]

Test Guideline 870.5100); a mammalian erythrocyte micronucleus test 
(OPPTS Test Guideline 870.5395) using the intraperitoneal route; and a 
repeated dose 28-day oral toxicity test (OPPTS Test Guideline 870.3050 
or OECD 407 test guideline) in rodents. The 28-day oral study should 
include, for all test doses, a neurotoxicity functional observational 
battery (FOB), as described in neurotoxicity screening battery (OPPTS 
Test Guideline 870.6200). Test reports should include protocols 
approved by EPA, certificate of analysis for the test substance, raw 
data, and results.

CFR citation: 40 CFR 721.10212.
PMN Number P-09-253
Chemical name: Polyether polyester copolymer phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an additive for molding compounds. 
Based on EcoSAR analysis of test data on analogous organic phosphates, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 22 ppb of the PMN substance in surface waters. As described 
in the PMN, the substance will not be released to surface waters. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance resulting in 
release to surface waters may cause significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that results of the following 
tests would help characterize the environmental effects of the PMN 
substance: Ready biodegradability test (OPPTS Test Guideline 835.3110); 
a fish acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075) using the flow-through method with mean measured 
concentrations; an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010) using the flow-through method 
with mean measured concentrations; and an algal toxicity test, tiers I 
and II (OPPTS Test Guideline 850.5400) using the static method with 
mean measured concentrations. Test reports should include protocols 
approved by EPA, certificate of analysis for the test substance, raw 
data, and results.

CFR citation: 40 CFR 721.10213.
PMN Number P-09-286
Chemical name: Poly(oxyalkylenediyl), .alpha.-substituted 
carbomonocycle-.omega.-substituted carbomonocycle (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a coatings resin. Based on EcoSAR 
analysis of test data on analogous 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, the substance 
is not released to surface waters. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in release to surface waters may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A ready biodegradability - CO2 in sealed 
vessels (headspace test) (OECD 310 test guideline); a fish early-life 
stage toxicity test (OPPTS Test Guideline 850.1400) using the flow-
through method with measured concentrations; a daphnid chronic toxicity 
test (OPPTS Test Guideline 850.1300) using the flow-through method with 
measured concentrations; and an algal toxicity test, tiers I and II 
(OPPTS Test Guideline 850.5400) using the static method with measured 
concentrations. Test reports should include protocols approved by EPA, 
certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10214.
PMN Number P-09-385
Chemical name: Benzenepropanol, .beta.-methyl-.
CAS number: 7384-80-7.
Basis for action: The PMN states that the substance will be used as a 
raw material to manufacture another chemical. Based on test data on the 
PMN substance, EPA identified possible skin sensitization concerns from 
dermal exposure to the PMN substance. Based on test data on analogous 
substances, the Agency identified concerns for liver toxicity, kidney 
toxicity, neurotoxicity, and possible developmental toxicity to workers 
exposed dermally to the PMN substance. For the uses described in the 
PMN, worker inhalation exposure is not expected and EPA does not expect 
significant dermal exposure due to the use of impervious gloves. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that any use of the substance other than 
as an intermediate, or without the use of impervious gloves where there 
is potential for dermal exposure, may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity test (OPPTS Test Guideline 870.3100) in rodents would 
help characterize the human health effects of the PMN substance. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10215.
PMN Number P-09-411
Chemical name: 2-Propenoic acid, 3-(5,5,6-trimethylbicyclo[2.2.1]hept-
2-yl)cyclohexyl ester.
CAS number: 903876-45-9.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a thermoset adhesive component. EPA has 
identified health and environmental concerns because the substance may 
be a persistent, bio-accumulative, and toxic (PBT) chemical, based on 
physical/chemical properties of the PMN substance, as described in the 
New Chemical Program's PBT category (64 FR 60194; November 4, 1999) 
(FRL-6097-7). EPA estimates that the PMN substance will persist in the 
environment more than two months and estimates a bioaccumulation factor 
of greater than or equal to 5,000. Also, based on test data on 
analogous acrylates, EPA believes exposure to the PMN substance may 
cause systemic human health effects and predicts toxicity to aquatic 
organisms. As described in the PMN, significant worker exposure is 
unlikely, and the substance is neither released to surface waters nor 
landfilled. 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 predictable or 
purposeful release containing the PMN substance into the waters of the 
United States or any disposal of the manufacturing, process, or use 
stream of the PMN substance other than by incineration may cause 
serious health effects and significant adverse environmental effects, 
since the PMN substance has been characterized by EPA as a PBT 
substance that can migrate to ground water. Based on this

[[Page 57176]]

information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of the tiered 
testing described in the New Chemicals Program's PBT Category would 
help characterize the PBT attributes of the PMN substance. Test reports 
should include protocols approved by EPA, certificate of analysis for 
the test substance, raw data, and results.

CFR citation: 40 CFR 721.10216.
PMN Number P-09-426
Chemical name: Branched and linear alcohols (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
site-limited raw material. Based on structure activity relationship 
analysis of test data on analogous neutral organic chemicals, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 1 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the substance are not expected to result in 
surface water concentrations that exceed 1 ppb. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: Based on the results of the potential solubility 
pretest either a water solubility: column elution method; shake flask 
method test (OPPTS Test Guideline 830.7840) or a water solubility: 
generator column method test (OPPTS Test Guideline 830.7860) and an 
algal toxicity test, tiers I and II (OPPTS Test Guideline 850.5400) 
using static method and mean measured concentrations. Based on the 
results of these tests, a fish acute toxicity test, freshwater and 
marine (OPPTS Test Guideline 850.1075), and an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS Test Guideline 
850.1010) may also be recommended. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10217.
PMN Number P-09-436
Chemical name: 2-Propenoic acid, 2-methyl-, C12-15-branched and linear 
alkyl esters, telomers with alkyl 2-[[(alkylthio)thioxomethyl]thio]-2-
alkanoate, aminoalkyl methacrylate and alkyl methacrylate, tert-Bu 2-
ethylhexanoperoxoate-initiated (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a lubricant additive. Based on EcoSAR 
analysis of test data on analogous polycationic polymers, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
410 ppb of the PMN substance in surface waters. As described in the 
PMN, during manufacturing the substance will not be released to surface 
waters. During processing and use, releases of the substance are not 
expected to result in surface water concentrations that exceed 410 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 predictable or purposeful release 
to surface waters of a manufacturing stream associated with any use of 
the substance may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075); a fish acute toxicity test mitigated 
by humic acid (OPPTS Test Guideline 850.1085); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS Test Guideline 
850.1010); and an algal toxicity test, tiers I and II (OPPTS Test 
Guideline 850.5400). Fish and daphnid tests should be performed using 
the flow-through method with mean measured concentrations. Algal 
testing should be performed using the static method with mean measured 
concentrations. Test reports should include protocols approved by EPA, 
certificate of analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10218.
PMN Number P-09-451
Chemical name: Butanamide,N-[substituted phenyl]-
[(alkoxynitrophenyl)diazenyl]-3-oxo- (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a dispersion 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, the substance will not be 
released to surface waters. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400) and a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300). Both tests should be performed using the flow-
through method with mean measured concentrations. Test reports should 
include protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10219.
PMN Number P-09-478
Chemical name: Phosphoric acid, polymer with cycloaliphatic diglycidyl 
ether, alkylethers (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a component of a coating. Based on 
EcoSAR analysis of test data on analogous polynonionic phosphate 
polymers, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 8 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance will not be released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that any use of the 
substance resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A fish acute toxicity test, freshwater and marine 
(OPPTS Test Guideline 850.1075) using the flow-through method with mean 
measured

[[Page 57177]]

concentrations; an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS Test Guideline 850.1010) using the flow-through method 
with mean measured concentrations; and an algal toxicity test, tiers I 
and II (OPPTS Test Guideline 850.5400) using the static method with 
mean measured concentrations. EPA also recommends that the special 
considerations for conducting aquatic laboratory studies (OPPTS Test 
Guideline 850.1000) be followed to facilitate solubility in the test 
media, because of the PMN's low water solubility. Test reports should 
include protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10220.
PMN Number P-09-542
Chemical name: 3-Nonen-1-ol, 1-acetate, (3Z)-.
CAS number: 13049-88-2.
Basis for action: The PMN states that the substance will be used as a 
fragrance in the manufacture of scented consumer products. Based on 
EcoSAR analysis of test data on analogous esters, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 9 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 9 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 9 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 the 
following tests would help characterize the environmental effects of 
the PMN substance: 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, tiers I and II (OPPTS Test Guideline 850.5400). Fish and 
daphnid testing should be performed using the flow-through method with 
mean measured concentrations. Algal testing should be performed using 
the static method with mean measured concentrations. Test reports 
should include protocols approved by EPA, certificate of analysis for 
the test substance, raw data, and results.

CFR citation: 40 CFR 721.10221.
PMN Number P-09-581
Chemical name: Styrenyl surface treated manganese ferrite (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
raw material intermediate used in the manufacture of polymerized 
pigments. Based on test data on analogous respirable, poorly soluble 
particles, subcategory titanium dioxide, EPA identified concerns for 
lung toxicity from lung overload if workers inhale the PMN substance. 
As described in the PMN, worker inhalation exposure will be minimal due 
to the use of adequate personal protective equipment. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that serious health effects may result from use of the 
substance without a NIOSH-approved respirator with an APF of at least 
10 where there is potential inhalation exposure or use of the substance 
other than as a raw material intermediate used in the manufacture of 
polymerized pigments. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day 
holding period would help characterize the human health effects of the 
PMN substance. A carcinogenicity test (OPPTS Test Guideline 870.4200) 
conducted via inhalation may be recommended, if the 90-day inhalation 
toxicity test indicates carcinogenic potential. Test reports should 
include protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10222.
PMN Number P-09-582
Chemical name: Styrenyl surface treated manganese ferrite with acrylic 
ester polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
polymerized pigment used in the manufacture of electronic inks. Based 
on test data on analogous respirable, poorly soluble particles, 
subcategory titanium dioxide, EPA identified concerns for lung toxicity 
from lung overload if workers inhale the PMN substance. As described in 
the PMN, worker inhalation exposure will be minimal due to the use of 
adequate personal protective equipment. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that serious health effects may result from use of the 
substance without a NIOSH-approved respirator with an APF of at least 
10 where there is potential inhalation exposure or use of the substance 
other than as a polymerized pigment used in the manufacture of 
electronic inks may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS Test Guideline 870.3465) with a 60-day 
holding period would help characterize the health effects of the PMN 
substance. A carcinogenicity test (OPPTS Test Guideline 870.4200) 
conducted via inhalation may be recommended, if the 90-day inhalation 
toxicity test indicates carcinogenic potential. Test reports should 
include protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.

CFR citation: 40 CFR 721.10223.
PMN Number P-10-9
Chemical name: Diglycidylaniline (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
reactive epoxide for use in producing reinforced composites (open/non-
dispersive use). Based on test data on the PMN substance, EPA 
identified concerns for mutagenicity. Based on test data on analogous 
epoxides, EPA identified concerns for oncogenicity, mutagenicity, 
developmental toxicity, reproductive toxicity, liver and kidney 
toxicity, and skin and lung sensitization. As described in the PMN, 
worker inhalation exposure is not expected and dermal exposure will be 
minimal due to the use of adequate personal protective equipment. 
Additionally, based on test data on the PMN substance, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 5 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance will not be released to surface waters. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that 1) any use of the substance without the use of impervious 
gloves where there is potential for dermal exposure may cause serious 
health effects, 2) manufacture, processing, or use of the substance in 
a powder form may cause serious health effects, and 3) any use of the 
substance

[[Page 57178]]

resulting in release to surface waters may cause serious health effects 
and significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C), (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the human health and 
environmental effects of the PMN substance: A carcinogenicity test 
(OPPTS Test Guideline 870.4200); a 90-day dermal toxicity test (OPPTS 
Test Guideline 870.3250) in rats, with attention to pathology of the 
reproductive organs; a fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300). All aquatic toxicity testing should be performed 
using the flow-through method with mean measured concentrations. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.

CFR citation: 40 CFR 721.10224.
PMN Number P-10-14
Chemical name: Quino[2,3-b] acridine-7,14-dione, 2,9-dichloro-5,12-
dihydro [4-[[2-(sulfooxy) ethyl] substituted] phenyl]-, sodium salt 
(1:1) (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance w