Significant New Use Rules on Certain Chemical Substances, 29982-29998 [E9-14780]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29982-29998]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14780]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0252; FRL-8417-6]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 23 
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 23 chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. The required notification will provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: The effective date of this rule is August 24, 2009 without 
further notice, unless EPA receives written adverse or critical 
comments, or notice of intent to submit adverse or critical comments 
before July 24, 2009. This rule shall be promulgated for purposes of 
judicial review at 1 p.m. (e.s.t.) on July 8, 2009.
    If EPA receives written adverse or critical comments, or notice of 
intent to submit adverse or critical comments, on one or more of these 
SNURs before July 24, 2009, EPA will withdraw the relevant sections of 
this direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.
    Additionally, significant new use designations for a chemical 
substance are legally established as of the date of publication of this 
direct final rule June 24, 2009. See the discussion in Unit VII. for 
more specific details.
    Further, for persons intending to import or export any of the 
chemical substances in this rule, they are subject to the TSCA section 
13 import certification requirements and the export notification 
provisions of TSCA section 12(b) as of July 24, 2009. See the 
discussion in Unit I.A. and Unit II.C. for more specific details.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0252, 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-2008-0252. The DCO is open from 8 a.m. to 
4 p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the DCO is (202) 564-8930. Such deliveries are only accepted 
during the DCO's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0252. EPA's policy is that all comments received will be included 
in the public 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 public 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. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at https://www.epa.gov/epahome/dockets.htm.
    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

[[Page 29983]]

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 Federal holidays. The telephone 
number of the EPA/DC Public Reading Room is (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine and subject to search. Visitors will be 
provided an EPA/DC badge that must be visible at all times in the 
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.
    For technical information contact: Tracey Klosterman, Chemical 
Control Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-2209; e-mail 
address: klosterman.tracey@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
Chemical manufacturing and petroleum refineries.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in Sec.  721.5. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the technical person listed under FOR 
FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Chemical 
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import 
certification requirements promulgated at 19 CFR 12.118 through 12.127 
and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 
707, subpart B). Chemical importers must certify that the shipment of 
the chemical substance complies with all applicable rules and orders 
under TSCA. Importers of chemicals subject to these SNURs must certify 
their compliance with the SNUR requirements. In addition, any persons 
who export or intend to export a chemical substance that is the subject 
of this rule on or after July 24, 2009 are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
Sec.  721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.

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

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

II. Background

A. What Action is the Agency Taking?

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

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

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

C. Applicability of General Provisions

    General provisions for SNURs appear in 40 CFR part 721, subpart A. 
These provisions describe persons subject to the rule, recordkeeping 
requirements,

[[Page 29984]]

exemptions to reporting requirements, and applicability of the rule to 
uses occurring before the effective date of the rule. Provisions 
relating to user fees appear at 40 CFR part 700. According to Sec.  
721.1(c), persons subject to these SNURs must comply with the same 
notice requirements and EPA regulatory procedures as submitters of PMNs 
under TSCA section 5(a)(1)(A). In particular, these requirements 
include the information submission requirements of TSCA section 5(b) 
and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), 
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUN, EPA may take regulatory action under TSCA section 
5(e), 5(f), 6, or 7 to control the activities for which it has received 
the SNUN. If EPA does not take action, EPA is required under TSCA 
section 5(g) to explain in the Federal Register its reasons for not 
taking action.
    Chemical importers are subject to the TSCA section 13 (15 U.S.C. 
1612) import certification requirements promulgated at 19 CFR 12.118 
through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears 
at 40 CFR part 707, subpart B). Chemical importers must certify that 
the shipment of the chemical substance complies with all applicable 
rules and orders under TSCA. Importers of chemical substances subject 
to a proposed or final SNUR must certify their compliance with the SNUR 
requirements. In addition, any persons who export or intend to export a 
chemical substance identified in a proposed or final SNUR are subject 
to the export notification provisions of TSCA section 12(b) (15 U.S.C. 
2612 (b)) (see Sec.  721.20), and must comply with the export 
notification requirements in 40 CFR part 707, subpart D.

III. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new use must be made after 
consideration of all relevant factors, including:
     The projected volume of manufacturing and processing of a 
chemical substance.
     The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
     The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorized EPA to consider any other relevant factors.
    To determine what would constitute a significant new use for the 23 
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 above four factors listed in TSCA section 
5(a)(2).

IV. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 23 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) 
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 that are subject to ``risk-
based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA 
determined that activities associated with the PMN substances may 
present unreasonable risk to human health or the environment. Those 
consent orders require protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNURs'' on these PMN substances are promulgated pursuant to 
Sec.  721.160, and are based on and consistent with the provisions in 
the underlying consent orders. The 5(e) SNURs designate as a 
``significant new use'' the absence of the protective measures required 
in the corresponding consent orders.
    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 19 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, for 
a variety of reasons, EPA did not find that the use scenario described 
in the PMN triggered the determinations set forth under TSCA section 
5(e). EPA, however, does believe that certain changes from the use 
scenario described in the PMN could result in increased exposures, 
thereby constituting a ``significant new use.'' These so-called ``non-
5(e) SNURs'' are promulgated pursuant to Sec.  721.170. EPA has 
determined that every activity designated as a ``significant new use'' 
in all non-5(e) SNURs issued under Sec.  721.170 satisfies the two 
requirements stipulated in Sec.  721.170(c)(2), i.e., these significant 
new use activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may

[[Page 29985]]

be accompanied by changes in exposure or release levels that are 
significant in relation to the health or environmental concerns 
identified'' for the PMN substance.
PMN Number P-05-1
Chemical name: Formaldehyde, polymer with dialkylphenylamine, 
dialkylphenol and trimethylhexanediamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
curing agent for epoxy coating systems. Based on test data on analogous 
phenols, aliphatic amines, and benzyl amines, EPA predicts toxicity to 
aquatic organisms may occur at concentrations that exceed 4 parts per 
billion (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 ready 
biodegradability test (OPPTS 835.3110 test guideline); a fish acute 
toxicity test, freshwater and marine (OPPTS 850.1075 test guideline 
(public draft)); an aquatic invertebrate acute toxicity test, fresh 
water daphnids (OPPTS 850.1010 test guideline (public draft)); and an 
algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)) would help characterize the environmental effects of 
the PMN substance. All aquatic toxicity testing should be performed 
using the static method with nominal concentrations at a pH of 7. 
Further, a certificate of analysis should be provided for the test 
substance.
CFR citation: 40 CFR 721.10134.
PMN Number P-05-11
Chemical name: Phosphinic acid, P,P-diethyl-, zinc salt (2:1).
CAS number: 284685-45-6.
Basis for action: The PMN states that the substance will be used as a 
flame retardant for polyamide thermoplastic epoxy resins. Based on test 
data on the PMN substance and analogous zinc salts, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
12 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 12 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 12 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 850.1400 test guideline (public 
draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)) would help characterize the 
environmental effects of the PMN substance. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10135.
PMN Number P-05-177
Chemical name: 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, 
reaction products with hexakis(alkoxyalkyl)melamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
base resin in UV/EB curable and peroxide curable formulations. Based on 
test data on analogous methacrylates and esters, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 100 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 Zahn-
Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish acute 
toxicity test, freshwater and marine (OPPT 850.1075 test guideline 
(public draft)); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); and 
an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)) would help characterize the environmental effects of 
the PMN substance. Fish and daphnia testing should be performed using 
the flow-through method with measured concentrations. Algal testing 
should be performed using the static method with measured 
concentrations. Further, a certificate of analysis should be provided 
for the test substance.
CFR citation: 40 CFR 721.10136.
PMN Number P-05-329
Chemical name: Halogenated phenoxy aromatic (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
fungicide intermediate. EPA identified health and environmental 
concerns because the substance may be a persistent, bioaccumulative, 
and toxic (PBT) chemical, based on physical/chemical properties of the 
PMN substance, as described in the New Chemicals Program's PBT Category 
(64 FR 60194; November 4, 1999) (FRL-6097-7). EPA estimates that the 
PMN substance will persist in the environment more than two months and 
estimates a bioaccumulation factor of greater than or equal to 1,000. 
Also, based on test data on analogous neutral organic substances, EPA 
predicts toxicity to aquatic organisms. As described in the PMN, 
significant worker exposure is unlikely and the substance is not 
released to surface waters. Therefore, EPA has not determined that the 
proposed 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 a subset of 
the tiered testing described in the New Chemicals Program's PBT 
Category would help characterize the PBT attributes of the PMN 
substance. EPA has determined that a ready biodegradability test (OPPTS 
835.3110 test guideline); a fish bioconcentration factor test (OPPTS 
850.1730 test guideline (public draft)); and a combined repeated dose 
study with the reproductive/developmental toxicity screening test 
(OPPTS 870.3650 or Organisation for Economic Co-operation and 
Development (OECD) 422 test guidelines) would help characterize the 
human health and environmental effects of the PMN substance. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10137.

[[Page 29986]]

PMN Number P-05-336
Chemical name: 3-Isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, 
ethyl ester.
CAS number: 163520-33-0.
Basis for action: The PMN states that the substance will be used as an 
herbicide safener in formulated pesticide products. Based on test data 
on the PMN substance submitted under TSCA section 8(e), the substance 
may cause liver, kidney, heart and spleen toxicity. Also, based on 
information submitted in the PMN Material Safety Data Sheet (MSDS), EPA 
has concerns for dermal sensitization. In addition, based on test data 
on the PMN substance and analogous aliphatic amines, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb of the PMN substance in surface waters. As described in the PMN, 
significant worker exposure is not expected. Further, general 
population exposure is not expected as the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, and 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 serious 
health effects and significant adverse environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(i), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS 850.1400 test guideline (public 
draft)) with rainbow trout and a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)) would help characterize the 
environmental effects of the PMN substance. Further, a certificate of 
analysis should be provided for the test substance. No human health 
testing is recommended at this time.
CFR citation: 40 CFR 721.10138.
PMN Number P-05-776
Chemical name: Ethanone, 1-(1-chlorocyclopropyl)-.
CAS number: 63141-09-3.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an intermediate. Based on test data on 
the PMN substance, EPA has concerns for acute toxicity, strong solvent 
(defatting) irritation, and dermal sensitization. Also, based on test 
data on analogous chloroalkanes, EPA has concerns for potential 
mutagenicity. In addition, based on test data on the PMN substance, EPA 
predicts toxicity to aquatic organisms may occur at concentrations that 
exceed 500 ppb of the PMN substance in surface waters. As described in 
the PMN, significant worker exposure is unlikely due to the use of 
adequate personal protective equipment. Significant general population 
exposure is not expected to result from the identified environmental 
releases from the proposed manufacturing, processing, or use of the 
substance. Further, significant environmental exposure is unlikely as 
the substance is not released to surface waters resulting in stream 
concentrations that exceed 500 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 or any use of the 
substance resulting in surface water concentrations exceeding 500 ppb 
may cause serious health effects and significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that the results of a porous 
pot test (OPPTS 835.3220 test guideline); a fish acute toxicity test, 
freshwater and marine (OPPTS 850.1075 test guideline (public draft)); 
an aquatic invertebrate acute toxicity test, freshwater daphnids (OPPTS 
850.1010 test guideline (public draft)); an algal toxicity test, tiers 
I and II (OPPTS 850.5400 test guideline (public draft)); a mammalian 
erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the 
intraperitoneal route; and a repeated dose 28-day oral toxicity study 
in rodents (OPPTS 870.3050 test guideline) would help characterize the 
human health and environmental effects of the PMN substance. Fish and 
daphnia testing should be performed using the flow-through method with 
measured concentrations. Algal testing should be performed using the 
static method with measured concentrations. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10139.
PMN Number P-06-33
Chemical name: Phosphoric acid, tin (2+) salt (2:3).
CAS number: 15578-32-2.
Basis for action: The PMN states that the substance will be used as a 
pigment in plastic compounds for laser marking and laser welding. Based 
on test data on the PMN substance and on analogous respirable, poorly 
soluble particulates, EPA has identified concerns that the PMN 
substance may cause lung overload, immunotoxicity, and reproductive 
toxicity. Also, based on test data on the PMN substance and analogous 
inorganic phosphates, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 10 ppb of the PMN substance in 
surface waters. As described in the PMN, significant worker exposure is 
unlikely due to the use of adequate personal protective equipment. 
Further, environmental exposure is unlikely, as the substance is not 
released to surface waters. Therefore, EPA has not determined that the 
proposed import, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that domestic 
manufacture or any use of the substance 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)(3)(i), (b)(3)(ii), 
(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 850.1075 test 
guideline (public draft)); an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)); an 
algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)); and a reproduction/developmental toxicity screening 
test (OPPTS 870.3550 test guideline) would help characterize the human 
health and environmental effects of the PMN substance. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10140.
PMN Number P-06-163
Chemical name: Oils, ginger, zingiber purpureum.
CAS number: 864662-46-4.
Basis for action: The PMN states that the substance will be used in 
fragrance compositions in cosmetic products, air fresheners, household 
cleaners, dishwashing detergents, and laundry detergents. Based on test 
data on analogous methyl eugenol, EPA identified concerns that the PMN 
substance may cause cancer. As described in the PMN, significant worker 
dermal exposure is unlikely due to the use of adequate dermal 
protection. Although there is potential for consumer exposure, 
significant dermal and inhalation exposures are not expected. 
Therefore, EPA has not determined that the proposed import, processing, 
or use of the substance may present an unreasonable risk. EPA has

[[Page 29987]]

determined, however, that domestic manufacture or use of the substance 
without the use of impervious gloves, where there is a potential for 
potential worker dermal exposure, may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of an in vitro 
mammalian erythrocyte micronucleus test (OPPTS 870.5395 test 
guideline); a salmonella typhimurium reverse mutation assay 
(OPPTS.870.5265 test guideline); and a carcinogenicity test (OPPTS 
870.4200 test guideline) would help characterize the human health 
effects of the PMN substance.
CFR citation: 40 CFR 721.10141.
PMN Number P-06-199
Chemical name: Oxabicycloalkane carboxylic acid alkanediyl 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 
analogous esters, EPA predicts toxicity to aquatic organisms may occur 
at concentrations that exceed 7 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 a fish 
early-life stage toxicity test (OPPTS 850.1400 test guideline (public 
draft)) with freshwater fish and a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)) would help characterize the 
environmental effects of the PMN substance. Further, a certificate of 
analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10142.
PMN Number P-06-733
Chemical name: Amines, bis (C11-14-branched and linear alkyl).
CAS number: 900169-60-0.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. EPA identified 
health and environmental concerns because the substance may be a PBT 
chemical, based on physical/chemical properties of the PMN substance, 
as described in the New Chemicals Program's PBT Category (64 FR 60194; 
November 4, 1999). EPA estimates that the PMN substance will persist in 
the environment more than two months and estimates a bioaccumulation 
factor of greater than or equal to 1,000. Also, based on test data on 
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms. 
As described in the PMN, significant worker exposure is unlikely and 
the substance is not released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that any predictable or purposeful release of 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. The 
neutralized substance should be used for all human health testing. 
Further, a certificate of analysis should be provided for the test 
substance.
CFR citation: 40 CFR 721.10143.
PMN Number P-06-805
Chemical name: Modified thiocarbamate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a mining chemical reagent. Based on 
test data on a structurally similar substance, EPA identified human 
health concerns for toxicity to liver, thymus, spleen, kidney, and red 
blood cells from exposure via drinking water and fish ingestion 
resulting from releases to surface and ground water. Further, based on 
test data on the PMN substance and analogous imides, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
70 ppb of the PMN substance in surface waters. As described in the PMN, 
the substance will not be released to surface and ground 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)(3)(ii), (b)(4)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a bacterial 
reverse mutation test (OPPTS 870.5100 test guideline); a mammalian 
erythrocyte micronucleus test (OPPTS 870.5395 test guideline) by the 
intraperitoneal route; a repeated dose 28-day oral toxicity in rodents 
(OPPTS 870.3050 test guideline); an acute oral toxicity (OPPTS 870.1100 
test guideline); a fish early life-stage toxicity test (OPPTS 850.1400 
test guideline (public draft)); a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)); and either a ready 
biodegradability test (OPPTS 835.3110 test guideline) or a sealed 
vessel carbon dioxide production test (OPPTS 835.3120 test guideline) 
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. Further, a 
certificate of analysis should be provided for the test substance.
CFR citation: 40 CFR 721.10144.
PMN Number P-06-816
Chemical name: Modified reaction products of alkyl alcohol, halogenated 
alkane, substituted epoxide, and amino compound (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: May 25, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the PMN substance will be as a 
hydrophobic surface active agent for cellulosic substrates and similar 
materials. The order was issued under section 5(e)(1)(A)(i) and 
(e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based on a finding that 
this substance may present an unreasonable risk of injury to the 
environment and human health, the substance may be produced in 
substantial quantities and may reasonably be anticipated to enter the 
environment in substantial quantities, and there may be significant (or 
substantial) human exposure to the substance and its potential 
degradation products. To protect against this exposure and risk, the 
consent order requires that the PMN substance be tested, before a 
certain production volume is reached, in various fate and physical/
chemical tests to determine its fate and composition in various media 
and conditions in the environment. In addition, for the fluorinated 
portion of the polymer, the submitter has agreed to

[[Page 29988]]

analyze, report, and limit specific fluorinated impurities of the PMN 
substance where the carbon chain meets or exceeds a specified length, 
if these values exceed those reported in the PMN. The SNUR designates 
as a ``significant new use'' the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other 
decomposition products of the PMN substance. These perfluorinated 
products may be released to the environment from incomplete 
incineration of the PMN substance at low temperatures. EPA has 
preliminary evidence, including data on some fluorinated polymers that 
suggests that, under some conditions, the PMN substance could degrade 
in the environment. EPA has concerns that these degradation products 
will persist (P) in the environment, could bioaccumulate (B) or 
biomagnify, and could be toxic (T) to people, wild mammals, and birds, 
based on data on analog chemicals, including perfluorooctanoic acid 
(PFOA) and other perfluorinated alkyls, including the presumed 
environmental degradation product. There is pharmacokinetic and 
toxicological data in animals on PFOA, as well as epidemiological and 
blood monitoring data in humans. Toxicity studies on PFOA indicate 
developmental, reproductive, and systemic toxicity in various species. 
Cancer may also be of concern. These factors, taken together, raise 
concerns for potential adverse chronic effects in humans and wildlife. 
There is also limited pharmacokinetic data and toxicological data in 
animals on other perfluoroalkyls, including the presumed degradation 
product and precursors. These data indicate a different and less toxic 
profile for the presumed degradation product and precursors. EPA 
expects that additional animal data will be developed under various 
consent orders that have the expected common degradation product or 
analog information.
Recommended testing: EPA has determined that the results of certain 
fate and physical/chemical property tests would help characterize 
possible effects of the substance. The PMN submitter has agreed not to 
exceed the production volume limit without performing these tests. The 
consent order contains one production volume limit. The PMN submitter 
has agreed not to exceed the production volume limit without performing 
the following studies: A modified semi-continuous activated sludge 
(SCAS) test for insoluble and volatile chemicals (OPPTS 835.5045 or 
OECD 302A test guidelines), with analysis for degradation products; a 
UV visible light absorption test (OPPTS 830.7050 or OECD 101 test 
guidelines); a direct photolysis rate in water by sunlight test (OPPTS 
835.2210 test guideline), if wavelengths greater than 290 nanometers 
(nm) are absorbed in the previous test; an indirect photolysis 
screening test (OPPTS 835.5270 test guideline); a phototransformation 
of chemicals on soil surfaces test (Draft OECD guideline January 2002) 
using two soils; an anaerobic biodegradability of organic compounds in 
digested sludge test (OECD 311 test guideline); an aerobic and 
anaerobic transformation in aquatic sediment systems test (OECD 308 
test guideline); and an aerobic sewage treatment simulation test (OECD 
303A test guideline).
CFR citation: 40 CFR 721.10145.
PMN Number P-07-87
Chemical name: Partially fluorinated condensation polymer (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 10, 2007.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the PMN substance will be as an open, 
non-dispersive carpet treatment. The order was issued under section 
5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) and (e)(1)(A)(ii)(II) of TSCA based 
on a finding that this substance may present an unreasonable risk of 
injury to the environment and human health, the substance may be 
produced in substantial quantities and may reasonably be anticipated to 
enter the environment in substantial quantities, and there may be 
significant (or substantial) human exposure to the substance and its 
potential degradation products. To protect against this exposure and 
risk, the consent order requires that the PMN substance be tested, 
before certain production volumes are reached, in various fate and 
physical/chemical tests to determine its fate and composition in 
various media and conditions in the environment. The order also limits 
the concentration of the PMN substance in products sold to non-
industrial users or distributors to non-industrial users that could 
spray apply the substance (after further dilution). Also, the consent 
order forbids the sale of the PMN substance to consumers in a spray 
application formulation. In addition, for the fluorinated portion of 
the polymer, the submitter has agreed to analyze, report, and limit 
specific fluorinated impurities of the PMN substance where the carbon 
chain meets or exceeds a specified length. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
Toxicity concern: EPA has concerns for potential incineration or other 
decomposition products of the PMN substance. These perfluorinated 
products may be released to the environment from incomplete 
incineration of the PMN substance at low temperatures. EPA has 
preliminary evidence, including data on some fluorinated polymers that 
suggests that, under some conditions, the PMN substance could degrade 
in the environment. EPA has concerns that these degradation products 
will persist (P) in the environment, could bioaccumulate (B) or 
biomagnify, and could be toxic (T) to people, wild mammals, and birds, 
based on data on analog chemicals, including PFOA and other 
perfluorinated alkyls, including the presumed environmental degradant. 
There is pharmacokinetic and toxicological data in animals on PFOA, as 
well as epidemiological and blood monitoring data in humans. Toxicity 
studies on PFOA indicate developmental, reproductive, and systemic 
toxicity in various species. Cancer may also be of concern. These 
factors, taken together, raise concerns for potential adverse chronic 
effects in humans and wildlife. There is also limited pharmacokinetic 
data and toxicological data in animals on other perfluoroalkyls, 
including the presumed degradant and precursors. These data indicate a 
different and less toxic profile for the presumed degradant and 
precursors. EPA expects that additional animal data will be developed 
under various consent orders that have the expected common degradant or 
analog information. EPA also has concerns that the PMN substance, under 
some conditions of use--particularly non-industrial, commercial, or 
consumer use--could cause lung effects, based on limited data on some 
perfluorinated compounds and an acute inhalation study on a related 
polymer.
Recommended testing: EPA has determined that the results of certain 
fate and physical/chemical property tests would help characterize 
possible effects of the substance. The PMN submitter has agreed not to 
exceed the production volume limits without performing these tests. The 
consent order contains three production volume limits. The PMN 
submitter has agreed not to exceed the first production volume limit 
without performing the following studies: A modified SCAS test for 
insoluble and volatile chemicals (OPPTS 835.5045 or OECD 302A test 
guidelines), with analysis for degradation products; a UV visible light

[[Page 29989]]

absorption test (OPPTS 830.7050 or OECD 101 test guidelines); a direct 
photolysis rate in water by sunlight test (OPPTS 835.2210 test 
guideline), if wavelengths greater than 290 nm are absorbed in the 
previous test; an indirect photolysis screening test (OPPTS 835.5270 
test guideline); a hydrolysis as a function of pH and temperature test 
(OPPTS 835.2130 test guideline); an aerobic and anaerobic 
transformation in soil test (OECD 307 test guideline); and an anaerobic 
biodegradability of organic compounds in digested sludge test (OECD 311 
test guideline). The PMN submitter has also agreed not to exceed the 
second higher production volume limit without performing the following 
tests: A phototransformation of chemicals on soil surfaces test (Draft 
OECD guideline January 2002) using two soils; an aerobic sewage 
treatment simulation test (OECD 303A test guideline); and an aerobic 
and anaerobic transformation in aquatic sediment systems test (OECD 308 
test guideline). Finally, the PMN submitter has also agreed not to 
exceed the highest production volume limit without performing an 
aerobic and anaerobic transformation in soil test (OECD 307 test 
guideline).
CFR citation: 40 CFR 721.10146.
PMN Number P-07-198
Chemical name: Acrylate derivative of alkoxysilylalkane ester and mixed 
metal oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a film coating additive. Based on test 
data on analogous respirable, poorly soluble particulates, EPA has 
concerns for lung effects for the PMN substance. Based on physical 
properties, EPA has concerns for potential systemic effects from dermal 
exposure to the PMN substance. As described in the PMN, worker 
inhalation exposure to particulates is not expected and dermal exposure 
is minimal due to the use of adequate dermal protection. 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 impervious gloves 
where there is a potential for dermal exposure; use of the substance 
other than as described in the PMN; or manufacture, processing, or use 
of the substance in a powder form, may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) would help characterize 
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10147.
PMN Number P-07-330
Chemical name: Acryloxy alkanoic alkane derivative with mixed metal 
oxides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a film coating additive. Based on test 
data on analogous respirable, poorly soluble particulates, EPA has 
concerns for lung effects for the PMN substance. Based on physical 
properties, EPA has concerns for potential systemic effects from dermal 
exposure to the PMN substance. As described in the PMN, worker 
inhalation exposure to particulates is not expected and dermal exposure 
is minimal due to the use of adequate dermal protection. 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 impervious gloves 
where there is a potential for dermal exposure; use of the substance 
other than as described in the PMN; or manufacture, processing, or use 
of the substance in a powder form, may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) would help characterize 
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10148.
PMN Numbers P-07-0522 and P-07-523
Chemical names: (P-07-522) Carbon black, (3-methylphenyl)-modified, 
substituted (generic) and (P-07-523) Carbon black, (4-methylphenyl)-
modified, substituted (generic).
CAS numbers: Not available.
Basis for action: The consolidated PMN states that the generic (non-
confidential) use of the substances will be as colorant process 
intermediates. Based on test data on analogous respirable, poorly 
soluble particulates, EPA has concerns for lung effects for the PMN 
substances. Based on physical properties, EPA has concerns for 
potential systemic effects from dermal exposure to the PMN substances. 
As described in the PMN, worker inhalation exposure to particulates is 
not expected and dermal exposure is minimal due to the use of adequate 
dermal protection. 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 use of the 
substances without the use of impervious gloves where there is a 
potential for dermal exposure; use of the substances other than as 
described in the PMN; or manufacture, processing, or use of the 
substances in a powder form, may cause serious health effects. Based on 
this information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) with a post-observation 
period of up to 3 months would help characterize the human health 
effects of the PMN substances. Evaluations should include markers of 
damage, oxidant stress, cell proliferation, the degree/intensity and 
duration of pulmonary inflammation, and a cytotoxic effects and 
histopathology of pulmonary tissues in addition to the standard 
requirements in the test guideline.
CFR citations: 40 CFR 721.10149 (P-07-522) and 40 CFR 721.10150 (P-07-
523).
PMN Number P-07-642
Chemical name: Modified styrene, divinylbenzene 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 cleaning and polishing chemical for 
semiconductor manufacturing. Based on test data on analogous 
respirable, poorly soluble particulates, EPA has concerns for lung 
effects for the PMN substance. Based on physical properties, EPA has 
concerns for potential systemic effects from dermal exposure to the PMN 
substance. As described in the PMN, worker inhalation exposure to 
particulates is not expected and dermal exposure is minimal due to the 
use of adequate dermal protection. 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 impervious gloves where there is a 
potential for dermal exposure; use of the substance other than as 
described in the PMN; or manufacture, processing, or use of the 
substance in a powder form, may cause serious health effects. Based on

[[Page 29990]]

this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) with a post-observation 
period of up to 3 months would help characterize the human health 
effects of the PMN substance. Evaluations should include markers of 
damage, oxidant stress, cell proliferation, the degree/intensity and 
duration of pulmonary inflammation, and a cytotoxic effects and 
histopathology of pulmonary tissues, in addition to the standard 
requirements in the test guideline.
CFR citation: 40 CFR 721.10151.
PMN Number P-07-674
Chemical name: Oxirane, substituted silylmethyl-, hydrolysis products 
with alkanol zirconium(4+) salt and silica, acetates (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a protective coating. Based on test 
data on analogous respirable, poorly soluble particulates, EPA believes 
that the PMN substance may cause lung effects. Based on physical 
properties, EPA believes that the PMN substance may cause systemic 
effects via dermal exposure. As described in the PMN, significant 
worker exposure is unlikely due to use in an enclosed process with 
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 impervious gloves 
where there is a potential for dermal exposure; use of the substance in 
non-enclosed processes during spray application; use other than as 
described in the PMN; or manufacture, processing, or use of the 
substance in a powder form, may cause serious health effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) with the addition of a 
post-exposure observation period of up to 3 months, and a glove 
permeation test (American Society for Testing and Materials (ASTM) F739 
and F1194-99 test guidelines) would help characterize the human health 
effects of the PMN substance. Evaluations for the inhalation study 
should include markers of damage, oxidant stress, cell proliferation, 
the degree/intensity and duration of pulmonary inflammation, and a 
cytotoxic effects and histopathology of pulmonary tissues, in addition 
to the standard requirements in the test guideline.
CFR citation: 40 CFR 721.10152.
PMN Number P-08-6
Chemical name: Modified methyl methacrylate, 2-hydroxyethyl 
methacrylate 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 resin for coatings. Based on test 
data on analogous respirable, poorly soluble particulates, EPA believes 
that the PMN substance might cause lung effects. Based on physical 
properties, EPA believes that the PMN substance may cause systemic 
effects via dermal exposure. As described in the PMN, worker inhalation 
exposure to particulates is not expected and dermal exposure is minimal 
due to the use of adequate dermal protection. 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 impervious gloves 
where there is a potential for dermal exposure; use of the substance 
other than as described in the PMN; or manufacture, processing, or use 
of the substance in a powder form, may cause serious health effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) with the addition of a 
post-exposure observation period of up to 3 months, and a glove 
permeation test (ASTM F739 and F1194-99 test guidelines) would help 
characterize the human health effects of the PMN substance. Evaluations 
for the inhalation study should include markers of damage, oxidant 
stress, cell proliferation, the degree/intensity and duration of 
pulmonary inflammation, and a cytotoxic effects and histopathology of 
pulmonary tissues, in addition to the standard requirements in the test 
guideline.
CFR citation: 40 CFR 721.10153.
PMN Number P-08-157
Chemical name: Quaternary ammonium compounds, dicoco alkyldimethyl, 
chlorides, reaction products with silica.
CAS number: 956147-76-5.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as raw material for the manufacture of 
release coatings. Based on test data on analogous respirable, poorly 
soluble particulates, EPA believes that the PMN substance may cause 
lung effects. Based on physical properties of the PMN substance, EPA 
believes that it may cause systemic effects via dermal exposure. As 
described in the PMN, worker inhalation exposure to particulates is not 
expected and dermal exposure is minimal due to the use of adequate 
dermal protection. 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 impervious gloves where there is a 
potential for dermal exposure; use of the substance other than as 
described in the PMN; or manufacture, processing, or use of the 
substance in a powder form, may cause serious health effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation 
toxicity test (OPPTS 870.3465 test guideline) with the addition of a 
post-exposure observation period of up to 3 months, and a glove 
permeation test (ASTM F739 and F1194-99 test guidelines) would help 
characterize the human health effects of the PMN substance. Evaluations 
for the inhalation toxicity study should include markers of damage, 
oxidant stress, cell proliferation, the degree/intensity and duration 
of pulmonary inflammation, and a cytotoxic effects and histopathology 
of pulmonary tissues, in addition to the standard requirements in the 
test guideline. For the glove permeation testing, gloves should be 
exposed to the expected conditions of exposure, including the likely 
combinations of chemical substances to which the gloves may be exposed 
to in the work area. Results should be recorded as a cumulative 
permeation rate as a function of time, and shall be documented in 
accordance with ASTM F739 using the format specified in ASTM F1194-99 
``Guide for Documenting Results of Chemical Permeation Testing on 
Protective Clothing Materials'' or its equivalent.
CFR citation: 40 CFR 721.10154.
PMN Number P-08-177
Chemical name: Multi-walled carbon nanotubes (generic).
CAS number: Not available.
Effective date of TSCA section 5(e) consent order: August 11, 2008.
Basis for TSCA section 5(e) consent order: The PMN states that the 
generic (non-confidential) use of the substance

[[Page 29991]]

will be as a property modifier in electronic applications and as a 
property modifier in polymer composites. The order was issued under 
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA. Based on test data 
on analogous respirable, poorly soluble particulates and on other 
carbon nanotubes (CNTs), EPA believes that the PMN substance might 
cause lung effects. To protect against this risk, the co