Significant New Use Rules on Certain Chemical Substances, 61566-61587 [2011-25497]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61566-61587]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25497]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-1075; FRL-8880-2]
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 36 
chemical substances which were the subject of premanufacture notices 
(PMNs). Four of these chemical substances are subject to TSCA section 
5(e) consent orders issued by EPA. This action requires persons who 
intend to manufacture, import, or process any of these 36 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 December 5, 2011. For purposes of 
judicial review, this rule shall be promulgated at 1 p.m. (E.S.T.) on 
October 19, 2011.
    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 November 4, 2011 (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-2010-1075, 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-2010-1075. 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-
2010-1075. 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 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 e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, will be publicly available only 
in hard copy. Publicly available docket materials are available 
electronically at https://www.regulations.gov, or, if only available in 
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA 
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution 
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of 
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the EPA/DC Public Reading Room 
is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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

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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 
November 4, 2011 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 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, import, or process the 
chemical substance for that use. Persons who must report are described 
in Sec.  721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the rule. 
Provisions relating to user fees appear at 40 CFR part 700. According 
to Sec.  721.1(c), persons subject to these SNURs must comply with the 
same notice requirements and EPA regulatory procedures as submitters of 
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA may take regulatory action under TSCA section 
5(e), 5(f), 6, or 7 to control the activities for which it has received 
the SNUN. If EPA does not take action, EPA is required under TSCA 
section 5(g) to explain in the Federal Register its reasons for not 
taking action.

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 36 
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, taking into consideration the four bulleted

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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 36 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) 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 4 PMN substances (P-06-36, P-06-37, P-09-146 and 
P-09-147) for which EPA determined, pursuant to TSCA section 5(e), that 
uncontrolled manufacture, import, processing, distribution in commerce, 
use, and disposal may present an unreasonable risk of injury to human 
health or the environment. Accordingly, these substances are subject to 
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I). 
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.
    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 32 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). However, EPA does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-5(e) SNURs issued under Sec.  721.170 satisfies the two 
requirements stipulated in Sec.  721.170(c)(2), i.e., these significant 
new use activities, ``(i) Are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental 
concerns identified'' for the PMN substance.
PMN Numbers P-06-36 and P-06-37
    Chemical names: (P-06-36) Rutile, tin zinc, calcium-doped and (P-
06-37) Rutile, tin zinc, sodium-doped.
    CAS numbers: (P-06-36) 389623-01-2 and (P-06-37) 389623-07-8.
    Effective date of TSCA section 5(e) consent order: February 17, 
2009.
    Basis for TSCA section 5(e) consent order: The PMN states that the 
substances will be used as colorants for polymers and industrial 
coatings. The order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that the substances may present an 
unreasonable risk of injury to human health. To protect against these 
risks, the consent order requires: Use of personal respiratory 
equipment, including a National Institute for Occupational Safety and 
Health (NIOSH)-certified respirator with an Assigned Protection Factor 
(APF) of at least 10, or compliance with a NCEL of 1.5 mg/m\3\ as an 8-
hour time weighted average; establishment of a hazard communication 
program; and restricts the company from manufacturing the PMN 
substances with a d10 particle size less than 100 nanometers, where d10 
particle size presents the particle size, as determined by laser light 
scattering, at which 10 percent by weight of the substance measured is 
smaller; and corresponding recordkeeping. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
    Toxicity concern: Based on structural activity relationship 
analysis derived from test data on structurally similar respirable, 
poorly soluble particulates, the PMN substances may cause lung overload 
and fibrosis in workers exposed to the PMN substances by the inhalation 
route.
    Recommended testing: EPA has determined that the following test 
would help characterize the human health effects of the PMN substances: 
A 90-day inhalation toxicity test (OPPTS Test Guideline 870.3465) in 
rats. The testing should include a 60-day recovery period to assess the 
progression or regression of any lesions; and include special attention 
to histopathology (inflammation and cell proliferation) of the lung 
tissues and to various parameters of the bronchoalveolar lavage fluid 
(BALF), e.g., marker enzyme activities, total protein content, total 
cell count, cell differential, and cell viability. 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

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commerce, use, and disposal of the PMN substances will remain in effect 
until the order is modified or revoked by EPA based on submission of 
that or other relevant information.
    CFR citations: 40 CFR 721.10230 (P-06-36) and 40 CFR 721.10231 (P-
06-37).
PMN Number P-08-694
    Chemical name: N-arylamino-phenol-formaldehyde condensate 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as a curative to be used 
with epoxy resin; a curative to be used with isocyanates in urethane 
systems; and an intermediate for synthesis of epoxy resins. Based on 
ecological structure-activity relationship (EcoSAR) analysis of test 
data on analogous phenols, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 1 part per billion (ppb) of the 
PMN substance in surface waters. As described in the PMN, releases of 
the substance are not expected to result in surface water 
concentrations that exceed 1 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that any 
use of the substance resulting in surface water concentrations 
exceeding 1 ppb may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with measured 
concentrations. Algal testing should be performed using the static 
method with measured concentrations. EPA recommends that the special 
considerations for conducting 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 721.10232.
PMN Number P-08-704
    Chemical name: Linear alkyl epoxide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) uses of the substance will be as site-limited 
intermediates for personal care ingredients and foam control agents. 
Based on EcoSAR analysis of test data on analogous epoxides, 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 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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with measured 
concentrations. Algal 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 721.10233.
PMN Number P-09-61
    Chemical name: Hydroxy-chloro-cyclopropyl-heteromonocyclic 
carboxylic acid (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
an industrial intermediate. Based on test data on the PMN substance, 
and EcoSAR analysis of test data on analogous phenols, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 6 
ppb of the PMN substance in surface waters. As described in the PMN, 
releases of the 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 any use of the substance resulting in surface water 
concentrations exceeding 6 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the environmental effects of the PMN substance. 
Testing should be performed using the flow-through 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 721.10234.
PMN Number P-09-72
    Chemical name: Phenol, 2-ethoxy-4-(ethoxymethyl)-.
    CAS number: 71119-07-8.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a perfumery ingredient. 
Based on EcoSAR analysis of test data on analogous phenols, EPA 
predicts that 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 
PMN substance may present an unreasonable risk. EPA has determined, 
however, that any use of the substance resulting in surface water 
concentrations exceeding 1 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with

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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 721.10235.
PMN Number P-09-139
    Chemical name: 1-Propanamine, 3-[2-(2-methoxyethoxy)ethoxy]-.
    CAS number: 91933-40-3.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a dispersant. Based on 
test data on an analogous substance submitted under TSCA section 8(e), 
EPA identified the following toxicity concerns from exposure to the PMN 
substance: Irritation to eyes; sensitization and corrosion to skin; and 
irritation to mucous membranes, lungs, and the gastrointestinal tract. 
For the uses described 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. However, EPA has determined that use of 
the substance other than as described in the PMN, or use of the 
substance in a consumer product, may result in significant human 
exposures. 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 an 
acute oral toxicity test (OPPTS Test Guideline 870.1100 or Organisation 
for Economic Co-operation and Development (OECD) Test Guideline 425); a 
bacterial reverse mutation test (OPPTS Test Guideline 870.5100); a 
mammalian erythrocyte micronucleus test (OPPTS Test Guideline 870.5395) 
via the intraperitoneal route; and a repeated dose 28-day oral toxicity 
study in rodents (OPPTS Test Guideline 870.3050 or OECD Test Guideline 
407) would help characterize the human health effects of the PMN 
substance. Testing should be performed on the neutralized 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 721.10236.
PMN Numbers P-09-146 and P-09-147
    Chemical names: (P-09-146) Formaldehyde, polymers with acetone-
phenol reaction products and phenol, sodium salts and (P-09-147) 
Formaldehyde, polymers with acetone-phenol reaction products and 
phenol, potassium sodium salts.
    CAS numbers: (P-09-146) 1065544-88-8 and (P-09-147) 1072227-60-1.
    Effective date of TSCA section 5(e) consent order: May 26, 2010.
    Basis for TSCA section 5(e) consent order: The PMNs state that the 
generic (non-confidential) use of the substances will be as adhesives. 
The order was issued under TSCA sections 5(e)(1)(A)(i) and 
5(e)(1)(A)(ii)(I) based on a finding that the substances may present an 
unreasonable risk of injury to human health. To protect against these 
risks, the consent order requires: Restrictions on formaldehyde 
residuals and polymer composition in the PMN substances; testing of 
representative samples at new manufacturing facilities; development and 
implementation of a written control plan for analysis and compliance 
with specified chemical composition limits; use only as listed in the 
consent order; no processing or distribution of the PMNs except when 
processed under specified conditions, where the PMNs are irreversibly 
cured into a thermoset polymer matrix; and maintaining certain records. 
The SNUR designates as a ``significant new use'' the absence of these 
protective measures.
    Toxicity concern: Based on physical-chemical properties, the PMN 
substances are expected to be absorbed from the lung and low molecular 
weight fractions are expected to be poorly absorbed from the 
gastrointestinal tract. Further, the PMN substances are not expected to 
be absorbed through the skin. EPA identified concerns for respiratory 
tract irritation, coughing; skin irritation and redness; eye 
irritation, watering, and redness; sensitization and severe allergic 
reactions. Further, based on test data on formaldehyde, a component of 
the PMN substances and regarded by EPA and International Agency for 
Research on Cancer (IARC) to be a carcinogen, EPA predicts human 
carcinogenicity.
    Recommended testing: EPA has determined that the following test 
would help characterize the human health effects of the PMN substances: 
Determining formaldehyde concentration in air from wood products, using 
a large scale chamber (American Society for Testing and Materials 
International (ASTM) Test Guideline E1333-10 or its equivalent) to 
demonstrate that formaldehyde emissions are equal to or less than 0.04 
parts per million (ppm). 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 substances will 
remain in effect until the order is modified or revoked by EPA based on 
submission of that or other relevant information.
    CFR citations: 40 CFR 721.10237 (P-09-146) and 40 CFR 721.10238 (P-
09-147).
PMN Numbers P-09-152 and P-09-153
    Chemical names: Trivalent chromium complexes of a substituted beta-
naphthol amine azo dye (generic).
    CAS numbers: Not available.
    Basis for action: The PMNs state that the use of the substances 
will be as acid dyes for coloring anodized aluminum. Based on test data 
on analogous substances including Beta-naphthylamine and chromium, EPA 
determined that the PMN substances may cause blood toxicity 
(methemoglobinemia), male reproductive toxicity, developmental 
toxicity, mutagenicity, and oncogenicity to workers and the general 
public exposed to the PMN substances via the lung or gastrointestinal 
tract. For the use described in the PMNs, worker inhalation exposure is 
unlikely, as the substances are imported, processed, and used as a wet 
press cake (greater than 30 percent water). Significant general 
population exposure is unlikely, as significant inhalation and drinking 
water exposures are not expected. Therefore, EPA has not determined 
that the proposed import, processing, or use of the substances may 
present an unreasonable risk. EPA has determined, however, that 
domestic manufacture, use of the substances other than as described in 
the PMNs, or the import, processing, or use of the substances in a 
powder or solid form (other than as a wet press cake that is comprised 
of greater than 30 percent water), may cause serious health effects. 
Based on this information, the PMN substances meet the concern criteria 
at Sec.  721.170(b)(1)(i)(C) and (b)(3)(ii).
    Recommended testing: EPA has determined that the results of a 
bacterial reverse mutation test (OPPTS Test Guideline 870.5100) with 
the prival modification with a concurrent positive control; and an 
unscheduled DNA synthesis in mammalian cells in culture (OPPTS Test 
Guideline 870.5550) in rat hepatocytes on the Beta-naphthylamine 
reduction product would help characterize the human health effects of 
the PMN substances. Test reports should include protocols approved by 
EPA, certificate of analysis for the test substance, raw data, and 
results.
    CFR citation: 40 CFR 721.10239.

[[Page 61571]]

PMN Numbers P-09-154, P-09-155, and P-09-156
    Chemical names: (P-09-154) Olefinic carbocycle, reaction products 
with alkoxysilane (generic); (P-09-155) olefinic carbocycle, reaction 
products with alkoxysilane, sulfurized (generic); and (P-09-156) 
olefinic carbocycle, reaction products with alkoxysilane, 
polysulfurized (generic).
    CAS numbers: (P-09-154) Not available; (P-09-155) not available; 
and (P-09-156) not available.
    Basis for action: The PMNs state that the generic (non-
confidential) uses of the substances will be as a processing additive 
intermediate (P-09-154 and P-09-155) and as a processing additive (P-
09-156). Based on EcoSAR analysis of test data on analogous 
alkoxysilanes, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 1 ppb of the PMN substance (P-09-154) and 6 
ppb of the PMN substance (P-09-156) in surface waters. Based on test 
data on analogous alkoxysilanes and thiols, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 1 ppb of the 
PMN substance (P-09-155) in surface waters. As described in the PMNs, 
the substances will not be released to surface waters. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substances may present an unreasonable risk. EPA has determined, 
however, that any use of the substances resulting in release to surface 
waters may cause significant adverse environmental effects. Based on 
this information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability--CO2 in sealed vessels test (OPPTS Test 
Guideline 835.3140); 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) would 
help characterize the environmental effects of the PMN substance. Fish 
and daphnid testing should be performed using the flow-through method 
with measured concentrations. Algal testing should be performed using 
the static method with measured concentrations. EPA recommends that the 
fate testing be performed first as the results may mitigate the need 
for further toxicity testing or change the testing recommendations. 
Testing should be performed on P-09-155. Test reports should include 
protocols approved by EPA, certificate of analysis for the test 
substance, raw data, and results.
    CFR citations: 40 CFR 721.10240 (P-09-154); 40 CFR 721.10241 (P-09-
155); and 40 CFR 721.10242 (P-09-156).
PMN Numbers P-09-193 and P-09-195
    Chemical names: (P-09-193) Phosphonic acid, P-[2-[bis(2-
hydroxyethyl)amino]ethyl]-, bis(2-chloroethyl) ester and (P-09-195) 
Phosphonic acid, P-[2-[bis(2-hydroxyethyl)amino]ethyl]-, 2-[bis(2-
chloroethoxy)phosphinyl]ethyl 2-chloroethyl ester.
    CAS numbers: (P-09-193) 55088-28-3 and (P-09-195) 1094213-37-2.
    Basis for action: The PMNs state that the substances will be used 
as intermediates in the manufacture of a polyurethane flame retardant. 
Based on the alkylating activity of the PMN substances, EPA has 
concerns for oncogenicity, mutagenicity, developmental toxicity, dermal 
and respiratory sensitization, and irritation to all tissues. 
Additionally, the Agency has concern for liver toxicity, kidney 
toxicity, heart toxicity, developmental toxicity, and neurotoxicity 
based on test data for analog substances submitted to the Agency under 
TSCA section 8(e). Based on EcoSAR analysis of test data on 
structurally similar aliphatic amines, EPA predicts toxicity to aquatic 
organisms at concentrations that exceed 8 ppb in surface waters. As 
described in the PMN, significant worker dermal and inhalation exposure 
is unlikely for the use described in the PMN due to the use of personal 
protective equipment and engineering controls. Further, significant 
general population and environmental exposure is unlikely as the 
substances are not released to water. 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 use 
of the substances other than as intermediates in the manufacture of a 
polyurethane flame retardant, use of the substances without the use of 
impervious gloves where there is potential for dermal exposure, or any 
use of the substances resulting in release to surface waters may cause 
significant adverse health or environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of 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) would help characterize 
the human health and environmental effects of the PMN substances. Fish 
and daphnid testing should be performed using the flow-through method 
with measured concentrations. Algal testing should be performed using 
the static method with measured concentration. Testing should be 
performed on P-09-193. Test reports should include protocols approved 
by EPA, certificate of analysis for the test substance, raw data, and 
results.
    CFR citations: 40 CFR 721.10243 (P-09-193) and 40 CFR 721.10244 (P-
09-195).
PMN Number P-09-207
    Chemical name: Branched and linear fatty alcohol ethoxylate 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
an intermediate in the manufacture of nonionic surfactants. Based on 
EcoSAR analysis of test data on analogous nonionic surfactants, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 14 ppb of the PMN substance in surface waters. For the use 
described in the PMN, releases of the PMN substance are not expected to 
result in surface water concentrations that exceed 14 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 an 
intermediate in the manufacture of nonionic surfactants may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with measured 
concentrations. Algal testing should be performed using the static 
method with measured concentrations. EPA recommends that the special 
considerations for conducting laboratory

[[Page 61572]]

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 721.10245.
PMN Number P-09-234
    Chemical name: Alkylpolyhydroxy polymer (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a drilling fluid 
additive. Based on EcoSAR analysis of test data on analogous alkyl 
ethoxylate nonionic surfactants, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 56 ppb of the PMN 
substance in surface waters. As described in the PMN, the substance is 
not released to surface waters. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable risk. EPA has determined, however, that any use 
of the substance resulting in release to surface waters may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with measured 
concentrations. Algal 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 721.10246.
PMN Number P-09-258
    Chemical name: Bis-phenoxyethanol fluorene diacrylate (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a raw material in ultra violet (UV) curable inks and coatings. EPA 
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 for 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 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 predictable or purposeful release 
containing the PMN substance into the waters of the United States may 
cause serious health effects and significant environmental effects, 
since the PMN substance has been characterized by EPA as a PBT. Based 
on this information, the PMN substance meets the concern criteria at 
Sec.  721.170(b)(3)(ii), (b)(4)(ii), and (b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
tiered testing described in the New Chemicals Program's PBT Category 
would help characterize the PBT attributes of the PMN substance. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10247.
PMN Number P-09-259
    Chemical name: Aromatic bromide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
a synthetic intermediate. EPA identified health and environmental 
concerns because the substance may be a 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). 
EPA estimates that the PMN substance will persist in the environment 
more than six months and estimates a bioaccumulation factor of greater 
than or equal to 5,000. Also, based on test data on analogous 
brominated aromatics and neutral organics (aryl halides), 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 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 use of the 
substance other than as described in the PMN or any predictable or 
purposeful release containing the PMN substance into the waters of the 
United States may cause serious health effects and significant 
environmental effects, since the PMN substance has been characterized 
by EPA as a PBT. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(ii), (b)(4)(ii), and 
(b)(4)(iii).
    Recommended testing: EPA has determined that the results of the 
tiered testing described in the New Chemicals Program's PBT Category 
would help characterize the PBT attributes of the PMN substance. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10248.
PMN Number P-09-316
    Chemical name: Disubstituted phenol (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate. 
Based on test data on analogous anilines and phenols, as well as on 
test data submitted to the Agency under TSCA section 8(e), EPA 
identified concerns for liver toxicity, mutagenicity, carcinogenicity, 
developmental toxicity, neurotoxicity, and male reproductive system 
toxicity to workers from inhalation exposure to the PMN substance. 
Additionally, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 6 ppb of the PMN substance in surface 
waters. For the use described in the PMN, significant worker exposure 
is unlikely due to the use of personal protective equipment. 
Furthermore, significant environmental exposure is unlikely as the 
substance is not released to surface water resulting 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 
other than as a chemical intermediate, or exceedance of the manufacture 
and import limit of 100 kg per year may cause serious health effects 
and significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern

[[Page 61573]]

criteria at Sec.  721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a 
combined chronic toxicity/carcinogenicity test (OPPTS Test Guideline 
870.4300); a bacterial reverse mutation test (OPPTS Test Guideline 
870.5100); a mammalian erythrocyte micronucleus test (OPPTS Test 
Guideline 870.5395); a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300) prolonged exposure; a fish early-life stage 
toxicity test (OPPTS Test Guideline 850.1400) using rainbow trout and a 
60-day minimum duration; and an algal toxicity test, tiers I and II 
(OPPTS Test Guideline 850.5400) would help characterize the human 
health and environmental effects of the PMN substance. 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 721.10249.
PMN Number P-09-356
    Chemical name: Zirconium lysine complex (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an adhesion promoter and 
corrosion inhibitor. Based on EcoSAR analysis of test data on analogous 
inorganic zirconium compounds, EPA predicts toxicity to aquatic 
organisms at concentrations that exceed 120 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 120 
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 120 ppb may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 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) would help characterize 
the environmental effects of the PMN substance. Fish and daphnid 
testing should be performed using the flow-through method with measured 
concentrations. Algal 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 721.10250.
PMN Number P-09-366
    Chemical name: Fatty acids, reaction products with alkanolamine 
(generic).
    CAS number: Not available.
    Basis for action: The PMN states that the substance will be used as 
an intermediate for a product used as a component of a multipurpose 
additive in gasoline. Based on test data on the PMN substance, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 400 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the PMN substance are not expected to result in 
surface water concentrations that exceed 400 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 an intermediate could 
result in exposures which may cause significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(i).
    Recommended testing: EPA has determined that the results of an 
aerobic and anaerobic transformation in aquatic sediment systems (OECD 
Test Guideline 308); a fish early-life stage toxicity test (OPPTS Test 
Guideline 850.1400); and a daphnid chronic toxicity test (OPPTS Test 
Guideline 850.1300) would help characterize the environmental effects 
of the PMN substance. Fish and daphnid testing should be performed 
using the flow-through method with measured concentrations. EPA 
recommends that the special considerations for conducting laboratory 
studies (OPPTS Test Guideline 850.1000) be followed to facilitate 
solubility in the test media, because of the PMN's low water 
solubility. EPA also recommends performing the fate testing first as 
the results may mitigate the need for further toxicity testing or 
change the testing requirements. Test reports should include protocols 
approved by EPA, certificate of analysis for the test substance, raw 
data, and results.
    CFR citation: 40 CFR 721.10251.
PMN Number P-09-373
    Chemical name: Thiosulfuric acid 
(H2S2O3), manganese(2+) salt (1:1).
    CAS number: 1033050-53-1.
    Basis for action: The PMN states that the substance will be used as 
a micronutrient manganese source for selected agricultural crops. Based 
on EcoSAR analysis of test data on analogous manganese salts, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 400 ppb of the PMN substance in surface waters. As described in 
the PMN, releases of the substance are not expected to result in 
surface water concentrations that exceed 400 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 400 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170(b)(4)(ii).
    Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 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) would help characterize 
the environmental effects of the PMN substance. 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 721.10252.
PMN Number P-09-388
    Chemical name: Butanedioic acid, 2-methylene-, polymer with 2,5 
furanedione, copper(2+) manganese(2+) sodium zinc salt, hydrogen 
peroxide-initiated.
    CAS number: 1134078-27-5.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a seed coating to provide 
micronutrients. Based on EcoSAR analysis of test data on analogous 
soluble complexes of zinc, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 34 ppb of the PMN substance in 
surface waters. As described in the PMN, releases of the

[[Page 61574]]

substance are not expected to result in surface water concentrations 
that exceed 34 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 34 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-CO2 in sealed vessels (headspace test) 
(OECD Test Guideline 310); 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) 
would help characterize the environmental effects of the PMN substance. 
Fish and daphnid testing should be performed using the flow-through 
method with measured concentrations. Algal testing should be performed 
using the static method with measured concentrations. EPA recommends 
performing the fate testing first as the results may mitigate the need 
for further toxicity testing or change the testing requirements. Test 
reports should include protocols approved by EPA, certificate of 
analysis for the test substance, raw data, and results.
    CFR citation: 40 CFR 721.10253.
PMN Number P-09-390
    Chemical name: Substituted acrylamide (generic).
    CAS number: Not available.
    Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a raw material. Based on 
test data on the PMN substance and EcoSAR analysis of test data on 
analogous amides and acrylamides, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 21 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 21 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 21 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 fish 
acute toxicity test, freshwater and marine (OPPTS Test Guideline 
850.1075) 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 would 
help characterize the environmental 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 721.10254.
PMN Number P-09-400
    Chemical name: Vinyl carboxylic acid ester (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 test 
data on the PMN substance and analogous vinyl esters, EPA identified 
concerns for dermal sensitization; dermal irritation; mutagenicity; 
neurotoxicity; and blood, liver, kidney, spleen, brain, testes, 
developmental, and reproductive toxicity to the general population if 
exposed to the PMN substance. In addition, based on test data on the 
PMN substance, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 15 ppb of the PMN substance in surface 
waters. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(ii) and (b)(4)(i). At the production 
volume stated in the PMN, general population exposure is limited. 
Further, as described in the PMN, releases of the PMN substance are not 
expected to result in surface water concentrations that exceed 15 ppb. 
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 that annual 
manufacture (including importation) of this PMN substance at volumes 
greater than 100,000 kilograms per year may result in significant human 
exposures. Further, EPA has determined that any use of the substance 
resulting in surface water concentrations exceeding 15 ppb may cause 
significant adverse environmental effects.
    Recommended testing: EPA has determined that the results of a 90-
day inhalation toxicity test (OPPTS Test Guideline 870.3465); a fish 
early-life stage toxicity test (OPPTS Test Guideline 850.1400); and a 
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would 
help characterize the human health and environmental effects of the PMN 
substance. Aquatic toxicity testing should be performed using the flow-
through 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 721.10255.
PMN Number P-09-479
    Chemical name: Benzoic acid, 4-(dimethylamino)-, 1,1'-
[(methylimino)di-2,I-ethanediyl] ester.
    CAS number: 925246-00-0.
    Basis for action: The PMN states that the substance will be used as 
a co-photoinitiator for UV-curable pigmentation inks; co-photoinitiator 
for photoresists, optical fibers, and printed plates; co-photoinitiator 
for UV-curable coatings; and co-photoinitiator for UV-curable adhesives 
and other coatings. Based on test data on the PMN substance and EcoSAR 
analysis of test data on analogous aliphatic amines and esters, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 2 ppb of the PMN substance in surface waters. As described in 
the PMN, the substance is not released to surface waters. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that any use of the substance resulting in release 
to surface waters may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(i) and (b)(4)(ii).
    Recommended testing: EPA has determined that the results of a ready 
biodegradability test (OPPTS Test Guideline 835.3100); a fish early-
life stage toxicity test (OPPTS Test Guideline 850.1400); and a da