Significant New Use Rules on Certain Chemical Substances, 65743-65766 [E8-26409]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 73, Number 215 (Wednesday, November 5, 2008)]
[Rules and Regulations]
[Pages 65743-65766]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26409]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0251; FRL-8371-3]
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 56 
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 56 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 January 5, 2009 without 
further notice, unless EPA receives written adverse or critical 
comments, or notice of intent to submit adverse or critical comments 
before December 5, 2008. This rule shall be promulgated for purposes of 
judicial review at 1 p.m. (e.s.t.) on November 19, 2008.
    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 December 5, 2008, 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.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2008-0251, 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-2008-0251. 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-
2008-0251. 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 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 Pennington, 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: pennington.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

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40 CFR 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. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127 and 19 CFR 127.28. Those persons must certify that the shipment 
of the chemical substance complies with all applicable rules and orders 
under TSCA, including any 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 [December 5, 
2008] are subject to the export notification provisions of TSCA section 
12(b) (15 U.S.C. 2611(b)) (see 40 CFR 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 rulemaking 
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. Additional rationale and background to this rule 
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 40 CFR 721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear under 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 final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 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 on 
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.
    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). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. 
Persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements, 
codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such 
persons must certify that the shipment of the chemical substance 
complies with all applicable rules and orders under TSCA, including any 
SNUR requirements. The EPA policy statement in support of the import 
certification appears at 40 CFR part 707, subpart B.

III. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 56 chemical substances under 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.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VI. for more information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The specific activities designated as significant new uses are 
specified in the regulatory text section of this document. Certain new 
uses, including production limits and other uses designated in the

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rule, are claimed as CBI. The procedure for obtaining confidential 
information is set out in Unit VII.
    This rule includes SNURs on 3 PMN substances that are subject to 
``risk-based'' consent orders under TSCA section 5(e)(1)(A)(ii)(I) 
wherein EPA determined that activities associated with the PMN 
substances may present unreasonable risk to 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 substances are promulgated pursuant to 40 CFR 
721.160, and are based on and consistent with the provisions in the 
underlying consent orders. In addition, the rule includes one SNUR on a 
PMN substance that is subject to an ``exposure-based'' consent order 
under section 5(e)(1)(A)(ii)(II) wherein EPA determined that the PMN 
substance is expected to be produced in substantial quantities, there 
may be significant or substantial human exposure, and the substance may 
enter the environment in substantial quantities. That consent order 
requires submission of certain test data to EPA before the manufacturer 
may exceed a specified production volume. These SNURs designate as a 
``significant new use'' the absence of the protective measures or 
exceedance of the production volume limit required in the 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 must 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 NCELs provisions currently exist 
in 40 CFR part 721, subpart B for SNURs. Therefore, for these cases, 
the individual SNURs in 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 40 CFR 721.30. 
Persons whose Sec.  721.30 requests to use the NCELs approach for SNURs 
are approved by EPA will receive NCELs provisions comparable to those 
contained in the corresponding TSCA section 5(e) consent order for the 
same chemical substance.
    This rule also includes SNURs on 52 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, 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 40 CFR 721.170. EPA has determined that every 
activity designated as a ``significant new use'' in all non-5(e) SNURs 
issued under 40 CFR 721.170 satisfies the two requirements stipulated 
in Sec.  721.170(c)(2), i.e., these significant new use activities: 
``(i) are different from those described in the premanufacture notice 
for the substance, including any amendments, deletions, and additions 
of activities to the premanufacture notice, and (ii) may be accompanied 
by changes in exposure or release levels that are significant in 
relation to the health or environmental concerns identified'' for the 
PMN substance.
PMN Number P-00-552
Chemical name: Modified salicylic acid, zirconium complex (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a photocopying chemical. EPA has 
identified health and environmental concerns because the substance may 
be a persistent, bio-accumulative, and toxic (PBT) chemical, based on 
physical/chemical properties of the PMN substance, as described in the 
New Chemical Program's PBT category (64 FR 60194; November 4, 1999) 
(FRL-6097-7). EPA estimates that the PMN substance will persist in the 
environment more than two months and estimates a bioaccumulation factor 
of greater than or equal to 5,000. Also, based on test data on the PMN 
substance and analogous substances, EPA believes exposure to the PMN 
substance may cause systemic human health effects and 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 adverse 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)(i), (b)(3)(ii), (b)(4)(i), and 
(b)(4)(ii).
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. EPA has 
determined that the results of a fish early-life stage toxicity test 
(OPPTS 850.1400 test guideline (public draft)) and a daphnid chronic 
toxicity test (OPPTS 850.1300 test guideline (public draft)) would help 
characterize the environmental effects of the PMN substance. Fish 
testing should be performed with rainbow trout for a 90-day period. 
Daphnid testing should be performed for a 21-day period.
CFR citation: 40 CFR 721.10089.
PMN Number P-01-595
Chemical name: Tertiary amine salt of glycol succinate (generic).
CAS number: Not available.
Effective date of section 5(e) consent order: July 26, 2004.
Basis for section 5(e) consent order: The PMN states that the generic 
(non-confidential) use of the substance will be as a pigment additive. 
The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) 
of TSCA based on a finding that this substance may present an 
unreasonable risk of injury to the environment. To protect against this 
risk, the consent order requires that the PMN substance be manufactured 
from specified feedstocks containing limited impurities. To ensure 
compliance, the consent order also requires that the feedstock is 
analyzed first at the time of initial commencement, then annually 
thereafter. The SNUR designates as a ``significant new use'' the 
absence of these protective measures.
Toxicity concern: Based on test data on analogous anionic substances, 
the Agency has concerns for toxicity to aquatic organisms at 
concentrations that exceed 20 parts per billion (ppb) in surface 
waters. EPA predicts higher toxicity to aquatic organisms could occur 
if the PMN substance is manufactured with feedstocks other than 
specified in the PMN submission. A manufacturing process other than 
that specified in the PMN could produce a product which is resistant to 
microbial biodegradation, resistant to removal in

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sewage treatment, and more persistent in the aquatic environment.
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 (OPPTS 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 possible effects of the PMN 
substance. The order does not require submission of the aforementioned 
information at any specified time or production volume. However, the 
order's restrictions on manufacture, import, processing, distribution 
in commerce, use, and disposal of the chemical substance will remain in 
effect until the order is modified or revoked by EPA based on 
submission of that or other relevant information.
CFR citation: 40 CFR 721.10090.
PMN Number P-02-135
Chemical name: 2(1H)-Pyrimidinone, tetrahydro-1,3-dimethyl-.
CAS number: 7226-23-5.
Basis for action: The PMN states that the substance will be used as an 
aprotic solvent and a catalyst. Based on test data on the PMN 
substance, EPA identified concerns for acute neurotoxicity, 
developmental toxicity and systemic effects to workers exposed dermally 
to the PMN substance. As described in the PMN, worker inhalation 
exposure is not expected and dermal exposure will be minimal due to the 
use of adequate personal protective equipment. 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, exceedence of the 20,000 kilogram 
annual import volume, use other than as described in the PMN, or use of 
the substance without the use of impervious gloves where there is a 
potential for dermal exposure, may cause serious health effects. Based 
on this information, the PMN substance meets the concern criteria at 
Sec.  721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity in rodents (OPPTS 870.3100 test guideline) and a 
reproduction and fertility effects test (OPPTS 870.3800 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10091.
PMN Number P-02-421
Chemical name: Poly(oxy-1,2-ethanediyl), .alpha.-sulfo-.omega.-[[1-[(2-
propen-1-yloxy)methyl]undecyl]oxy]-, ammonium salt (1:1); Poly(oxy-1,2-
ethanediyl), .alpha.-sulfo-.omega.-[[1-[(2-propen-1-
yloxy)methyl]tridecyl]oxy]-, ammonium salt (1:1).
CAS numbers: 352661-91-7 and 224646-44-0.
Effective date of section 5(e) consent order: September 12, 2003.
Basis for section 5(e) consent order: The PMN states that the generic 
(non-confidential) use of the substance will be as an emulsifier. The 
order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of 
TSCA based on a finding that this substance may present an unreasonable 
risk of injury to the environment. To protect against this risk, the 
consent order requires the company not to manufacture or import the PMN 
substance unless: (1) The mean number of moles of the ethoxy group is 
equal to or greater than 8 or (2) the average molecular weight is 
greater than 721 daltons. To ensure compliance, the consent order also 
requires that the substance is analyzed first at the time of initial 
commencement, then annually thereafter. The SNUR designates as a 
``significant new use'' the absence of these protective measures.
Toxicity concern: Based on test data on analogous anionic surfactants, 
EPA predicts toxicity to aquatic organisms to occur at concentrations 
that exceed 3 ppb in surface waters. PMN substances with fewer ethoxy 
groups could have higher toxicity.
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)); 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.
CFR citation: 40 CFR 721.10092.
PMN Numbers P-03-12 and P-03-13
Chemical name: Alkylamides, ethoxylated (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential) 
use of the substances will be as surfactants. Based on test data on 
structurally similar aliphatic amines, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 20 ppb in surface 
waters. As described in the amended PMNs, the substances are not 
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 other 
uses 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 a fish acute toxicity 
test, freshwater and marine (OPPTS 850.1075 test guideline (public 
draft)); a fish acute toxicity test mitigated by humic acid (OPPTS 
850.1085 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 substances. All aquatic toxicity tests 
should use the static method and nominal concentrations. EPA recommends 
that only the PMN substance described in P-03-13 needs to be tested. 
The chloride salt of the PMN substance should be tested at pH 7. The 
fish acute toxicity test mitigated by humic acid should be done twice 
with 20 mg humic acid/liter and 10 mg humic acid/liter. Fish 96-hour 
LC50 values should be determined in the fish acute toxicity tests 
mitigated by humic acid. Dilution water hardness in the fish and 
daphnid toxicity tests should be less than 180 mg/liter as CaCO3. 
Dilution water and growth medium total organic carbon (TOC) 
concentrations should be measured just prior to testing and should be 
less than 2.0 mg TOC/liter. The TOC in the dilution water of the humic 
acid controls should be measured at the start of the tests and 
reported.
CFR citation: 40 CFR 721.10093.
PMN Number P-03-272
Chemical name: Decene, branched and linear.
CAS number: 833482-31-8.
Basis for action: The PMN states that the substance will be used as a 
chemical intermediate. Based on test data on structurally similar 
neutral organic chemicals, EPA predicts toxicity to aquatic organisms 
may occur at concentrations that exceed 2 ppb 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

[[Page 65747]]

substance may present an unreasonable risk. EPA has determined, 
however, that other uses 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 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. All testing should be performed using the static 
method with measured concentrations in a closed vessel with no head 
space.
CFR citation: 40 CFR 721.10094.
PMN Number P-03-471
Chemical name: Oxetane, 3,3'-[oxybis(methylene)] bis[3-ethyl-.
CAS number: 18934-00-4.
Effective date of section 5(e) consent order: November 18, 2004.
Basis for section 5(e) consent order: The PMN states that the generic 
(non-confidential) use of the substance is an additive for industrial 
applications. The order was issued under section 5 (e)(1)(A)(i) and 
(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may 
present an unreasonable risk of injury to human health. To protect 
against this risk, the consent order requires use of gloves 
demonstrated by testing to be impervious (Polyvinyl Alcohol gloves with 
a thickness of no less than 31.3 mils or Silvershield/4H sleeves with a 
thickness of no less than 2.7 mils have satisfied this requirement for 
up to 8 hours), a hazard communication program, and an aggregate 
production volume limit for manufacture or import. The SNUR designates 
as a ``significant new use'' the absence of these protective measures.
Toxicity concern: Based on a 28-day repeated dose study on the PMN 
substance, the Agency has concerns for male reproductive toxicity and 
systemic toxicity.
Recommended testing: EPA has determined that the results of a combined 
repeated dose toxicity study with a reproductive/developmental toxicity 
screening test (OPPTS 870.3650 test guideline) in rats by gavage would 
help characterize possible effects of the PMN substance. The PMN 
submitter has agreed not to exceed the production volume limit without 
performing these tests.
CFR citation: 40 CFR 721.10095.
PMN Number P-03-614
Chemical name: Benzene, 1,4-bis (methoxymethyl)-.
CAS number: 6770-38-3.
Effective date of section 5(e) consent order: April 21, 2004.
Basis for section 5(e) consent order: The PMN states that the generic 
(non-confidential) use of the substance will be as an electronic 
chemical. The exposure based 5(e) order was issued under section 5 
(e)(1)(A)(i) and (e)(1)(A)(ii)(II) of TSCA based on a finding that the 
PMN substance is expected to be produced in substantial quantities, 
there may be significant or substantial human exposures, and the 
substance may enter the environment in substantial quantities. To 
protect against possible human health and environmental effects, the 
order requires submission of testing by a specified production volume.
Recommended testing: EPA has determined that the results of an acute 
oral toxicity test (OPPTS 870.1100 test guideline); a bacterial reverse 
mutation test (OPPTS 870.5100 test guideline); a mammalian erythrocyte 
micronucleus test (intraperitoneal route) (OPPTS 870.5395 test 
guideline); a repeated dose 28-day oral toxicity in rodents (OPPTS 
870.3050 test guideline), including for all test doses a neurotoxicity 
functional observational battery, as described in OPPTS 870.6200 (test 
guideline); a fish acute toxicity test (OPPTS 850.1075 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 ready biodegradability test (OPPTS 835.3110 test 
guideline) would help characterize possible 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. The PMN submitter has agreed not 
to exceed the production volume limit without performing these tests.
CFR citation: 40 CFR 721.10096.
PMN Numbers P-03-642 and P-03-643
Chemical names: (P-03-642) Disubstituted benzenesulfonic acid, alkali 
metal salt (generic) and (P-03-643) Disubstituted benzoic acid, alkali 
metal salt (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-confidential) 
use of the substances will be as starting materials for the manufacture 
of agrochemicals. Based on test data on the PMN substances and 
structurally similar analogs, EPA has concerns for irritation and 
possible corrosion to eyes, mucous membranes and lungs, as well as 
concerns for liver and male reproductive system toxicity. As described 
in the PMNs, significant inhalation exposure is unlikely. 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 other uses of the substances other than as 
described in the PMNs may result in serious health effects. Based on 
this information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a bacterial 
reverse mutation test (OPPTS 870.5100 test guideline); a mammalian 
erythrocyte micronucleus assay (OPPTS 870.5395 test guideline); a 
repeated dose 28-day oral toxicity study in rodents (OPPTS 870.3050 
test guideline); an acute oral toxicity (OPPTS 870.1100 test 
guideline); and a prenatal developmental toxicity study (OPPTS 870.3700 
test guideline) would help characterize the human health effects of the 
PMN substances. The prenatal developmental toxicity study should be 
performed on P-03-643, while all remaining tests should be performed on 
P-03-642.
CFR citations: 40 CFR 721.10097 (P-03-642) and 40 CFR 721.10098 (P-03-
643).
PMN Numbers P-03-715 and P-03-716
Chemical names: (P-03-715) Dialkyl dimethyl ammonium carbonate (1:1) 
(generic) and (P-03-716) Dialkyl dimethyl ammonium carbonate (2:1) 
(generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the substances will be used as 
metal treatment chemicals, and surfactants in hard surface cleaning 
applications. Based on test data on structurally similar substances, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 5 ppb in surface waters. As described in the PMNs, releases 
of the PMN substances are not expected to result in surface water 
concentrations that exceed 5 ppb. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substances 
may present an unreasonable risk. EPA has determined, however, that 
other uses of the substances resulting in surface water concentrations 
that exceed 5 ppb may

[[Page 65748]]

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)) and a porous pot test (OPPTS 835.3220 test guideline) would 
help characterize the environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10099 (P-03-715) and 40 CFR 721.10100 (P-03-
716).
PMN Number P-03-755
Chemical name: Copolymer of alkyl acrylate and ethyleneglycol 
dimethacrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an additive for paints and coatings. 
Based on test data for structurally similar polynonionic polymers, EPA 
has concerns for lung fibrosis if the substance is inhaled, due to its 
high molecular weight. As described in the PMN, worker inhalation 
exposure to the PMN substance will be minimal due to adequate personal 
protective equipment, and worker dermal exposure is not expected. 
Therefore, EPA has not determined that the proposed import, processing, 
or use of the substance may cause significant adverse effects. EPA has 
determined, however, that domestic manufacture or where there is 
potential inhalation exposure without the use of a National Institute 
for Occupational Safety and Health (NIOSH)-approved respirator with an 
assigned protection factor (APF) of at least 10, may result in serious 
health effects. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS 870.3465 test guideline) with a 60-day 
holding period in rats would help characterize the human health effects 
of the PMN substance.
CFR citation: 40 CFR 721.10101.
PMN Number P-04-126
Chemical name: Diphosphoric acid, compd. with piperazine (1:1).
CAS number: 66034-17-1.
Basis for action: The PMN states that the substance will be used as a 
flame retardant. Based on test data on analogous amines and inorganic 
phosphates, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 10 ppb in surface waters. As described in 
the PMN, the substance is not released to surface water. Therefore, EPA 
has not determined that the proposed manufacturing 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 
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)(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)); 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 tests should be performed using the static 
method with nominal concentrations.
CFR citation: 40 CFR 721.10102.
PMN Number P-04-235
Chemical name: Naphtha (Fischer-Tropsch), C4-11-alkane, branched and 
linear.
CAS number: 849101-58-2.
Basis for action: The PMN states that the substance will be used as an 
olefin manufacturing feed stock, specialty solvent, alcohol denaturant, 
and fuel blendstock. Based on test data on analogous neutral organic 
chemicals, EPA predicts toxicity to aquatic organisms may occur at 
concentrations that exceed 6 ppb in surface waters. As described in the 
PMN, all waste streams containing the substance will be incinerated and 
not released to surface waters or landfilled. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that disposal of the substance without incineration may result 
in release to surface waters and 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 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. Testing should be performed using the static method 
with measured concentrations in a closed vessel with no head space.
CFR citation: 40 CFR 721.10103.
PMN Number P-04-254
Chemical name: Halophosphate mixed metal complex (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a coating additive. Based on test data 
on structurally similar substances, EPA predicts toxicity to aquatic 
organisms may occur at concentrations that exceed 10 ppb in surface 
waters. As described in the PMN, releases of the PMN substance are not 
expected to result in surface water concentrations that exceed 10 ppb. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or uses of the substance may present an unreasonable risk. 
EPA has determined, however, that other uses of the substance resulting 
in release to surface waters at concentrations that exceed 10 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 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. The fish and daphnid tests should be performed using 
the flow-through method with measured concentrations. The algae test 
should be performed using the static method with measured 
concentrations.
CFR citation: 40 CFR 721.10104.
PMN Number P-04-417
Chemical name: Polyfluoroalkylether (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as source material for coating plastic 
parts. Based on test data on structurally similar chemicals, EPA has 
concerns for lung toxicity if the substance is inhaled, due to its 
reactivity with lung membranes. As described in the PMN, dermal and 
inhalation exposures to workers are not

[[Page 65749]]

expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that the use of the PMN 
substance involving an application method that generates a vapor, mist, 
or aerosol may result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity (OPPTS 870.3465 test guideline) with a 60-day 
holding period would help characterize the health effects of the 
substance.
CFR citation: 40 CFR 721.10105.
PMN Number P-04-419
Chemical name: Silica, [(ethenylsilylidyne)tris(oxy)] - modified.
CAS number: 649574-37-8.
Basis for action: The PMN states that the substance will be used as 
filler. Based on test data on analogous crystalline silica and other 
high molecular weight polymers, EPA has concerns for lung toxicity, 
lung overload, and cancer. As described in the PMN, significant worker 
inhalation exposure is not expected. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that 
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)(1)(i)(C) and 
(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS 870.3465 test guideline) in rats with 
special attention to histopathology (inflammation and cell 
proliferation) of the lung tissues and to various parameters of the 
bronchoalveolar lavage fluid (BALF) with a recovery period of 60 days; 
and a carcinogenicity test (OPPTS 870.4200 test guideline) in rats 
would help characterize the human health concerns of the PMN substance.
CFR citation: 40 CFR 721.10106.
PMN Number P-04-495
Chemical name: Naphthalenedisulfonic acid, [amino-hydroxy-
[(substituted)azo-sulfo-naphthaleneyl]azo]-hydroxy-[(methoxy-
sulfophenyl)azo], metal salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a dye. Based on test data on 
structurally similar beta-N-substituted naphthalene-based azo reduction 
products, EPA has concerns for carcinogenicity, mutagenicity, and 
developmental toxicity from exposure to the PMN substance. As described 
in the PMN, the substance is imported so domestic worker exposure is 
not expected. Although there is potential for short-term, infrequent 
consumer dermal exposure, based on physical-chemical properties of the 
PMN substance, dermal absorption of the intact dye is not expected. 
Therefore, EPA has not determined that the proposed importation or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that domestic manufacturing, or use other than that listed in 
the PMN, could result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a bacterial 
reverse mutation test (OPPTS 870.5100 test guideline) with the Prival 
modification and a concurrent positive control; and an unscheduled DNA 
synthesis in mammalian cells in culture (OPPTS 870.5550 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10107.
PMN Number P-04-498
Chemical name: Naphthalenedisulfonic acid, hydrozy-[[[(hydroxyl-
disulfo-naphthaleneyl)azo]-alkyl(C=1-5)-(sulfoalkoxy)cyclic]azo]-
substituted azo-, metal salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a dye. Based on test data on 
structurally similar beta-N-substituted naphthalene-based azo reduction 
products, EPA has concerns for carcinogenicity, mutagenicity, and 
developmental toxicity from exposure to the PMN substance. As described 
in the PMN, the substance is imported so domestic worker exposure is 
not expected. Although there is potential for short-term, infrequent 
consumer dermal exposure, based on physical-chemical properties of the 
PMN substance, dermal absorption of the intact dye is not expected. 
Therefore, EPA has not determined that the proposed importation or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that domestic manufacturing, or use other than that listed in 
the PMN, could result in serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a bacterial 
reverse mutation test (OPPTS 870.5100 test guideline) with the Prival 
modification with a concurrent positive control; and an unscheduled DNA 
synthesis in mammalian cells in culture (OPPTS 870.5550 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10108.
PMN Numbers P-04-508, P-04-509, and P-04-510
Chemical names: (P-04-508) Hexanoic acid, 2-ethyl-, mixed triesters 
with benzoic acid and trimethylolpropane; (P-04-509) Hexanoic acid, 2-
ethyl-, mixed diesters with benzoic acid and neopentlyl glycol; and (P-
04-510) Hexanoic acid, 2-ethyl-, mixed diesters with benzoic acid and 
diethylene glycol.
CAS numbers: (P-04-508) 610787-76-3; (P-04-509) 610787-77-4; and (P-04-
510) 610787-78-5.
Basis for action: The PMNs state that the substances will be used as 
plasticizers for products manufactured from polyvinyl chloride (PVC). 
Based on test data on structurally similar esters, EPA predicts chronic 
toxicity to aquatic organisms may occur at concentrations that exceed 1 
ppb in surface waters. Based on test data on the PMN substance, EPA has 
concerns for liver toxicity, reproductive toxicity, developmental 
toxicity, and a marginal concern for cancer. Also, if any diethylene 
glycol is released from ester hydrolysis of P-04-510, there is concern 
for acute poisoning (lethality) at high doses. As described in the 
PMNs, the substances are not be released to surface waters and worker 
inhalation and dermal exposures are not of concern. Consumer exposure 
to the PMN substances are not expected as the substances are compounded 
with other nonvolatile substances and are not expected to volatilize, 
leach, or otherwise be separated from the final product under normal 
conditions of use. Therefore, EPA has not determined that the proposed 
import, processing, or use of the substances may present an 
unreasonable risk to human health or the environment. EPA has 
determined, however, that domestic manufacture or any other uses 
resulting in release of the substances to surface waters may cause 
serious health effects and significant adverse environmental effects. 
Based on this information, the PMN substances meets the concern 
criteria at Sec.  721.170 (b)(1)(i)(C), (b)(3)(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)); a daphnid chronic toxicity test (OPPTS

[[Page 65750]]

850.1300 test guideline (public draft)); an algal toxicity test, tiers 
I and II (OPPTS 850.5400 test guideline (public draft)); a Zahn-
Wellens/EMPA test (OPPTS 835.3200 test guideline); a fish BCF (OPPTS 
850.1730 test guideline (public draft)); and a reproduction/
developmental toxicity screening test (OPPTS 870.3550 test guideline) 
would help characterize the environmental effects, environmental fate, 
and human health effects of the PMN substances. Testing for P-04-508, 
P-04-509, and P-04-510 should be tiered. Testing should first be 
completed on P-04-510. If the results indicate toxicity, then the 
testing should be repeated for P-04-509. If the results for P-04-509 
indicate toxicity, then the testing should be repeated for P-04-508.
CFR citations: 40 CFR 721.10109 (P-04-508), 40 CFR 721.10110 (P-04-
509); and 40 CFR 721.10111 (P-04-510).
PMN Number P-04-530
Chemical name: Ethanone, 2-chloro-1-(1-chlorocyclopropyl)-.
CAS number: 120983-72-4.
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 human health concerns for mutagenicity, 
acute toxicity, systemic toxicity (liver and kidney effects), lung 
toxicity, and dermal sensitization. Based on test data on structural 
analogs, EPA has health concerns for reproductive toxicity and systemic 
toxicity (cardiotoxicity and spleen effects). In addition, there is 
concern for carcinogenicity based on the results of the mutagenicity 
studies and the potential for the chemical to be an alkylating agent. 
Based on test data on structurally similar alpha-halo ketones, EPA 
predicts toxicity to aquatic organisms at concentrations that exceed 1 
ppb in surface waters. Since significant worker dermal and inhalation 
exposure is unlikely for the use described in the PMN due to adequate 
personal protective equipment and engineering controls, and since 
significant general population and environmental exposure is unlikely 
as the substance is not released to surface waters, 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 
other uses of the substance resulting in release of the PMN substance 
to surface water may cause serious health effects or significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170 (b)(1)(i)(C), 
(b)(3)(i), (b)(3)(ii), 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)) and a daphnid chronic toxicity test (OPPTS 850.1300 test 
guideline (public draft)) would help characterize the environmental 
effects of the PMN substance. These tests should be performed using the 
flow-through method with measured concentrations. EPA also has 
determined that the results of the following test would characterize 
the human health effects of the PMN substance: Combined repeated dose 
toxicity study with the reproduction/developmental screening (OPPTS 
870.3650 test guideline).
CFR citation: 40 CFR 721.10112.
PMN Number P-04-547
Chemical name: Thioether epoxy (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an epoxy monomer. Based on test data on 
structurally similar epoxides, EPA has health concerns for 
carcinogenicity, mutagenicity, sensitization, male reproductive 
effects, and severe irritation to all exposed tissues. As described in 
the PMN, significant worker exposure is unlikely, as dermal exposure is 
not expected. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk of injury to human health. EPA has determined, 
however, that use other than that listed in the PMN could result in 
serious health effects. Based on this information the PMN substance 
meets the concern criteria at Sec.  721.170 (b)(1)(i)(C) and 
(b)(3)(ii). Also, based on structural analogy to epoxides, EPA predicts 
toxicity to aquatic organisms may occur at concentrations that exceed 
30 ppb in surface waters. As described in the PMN, the substance is not 
released to water. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk of injury to the environment. EPA has determined, 
however, that any other uses of the substance resulting in release of 
the PMN substance 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 90-day 
inhalation toxicity test (OPPTS 870.3465 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)); and a ready biodegradability study (OPPTS 835.3110 
test guideline) would help characterize the human health and 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10113.
PMN Numbers P-04-578, P-04-579, P-04-580, P-04-581, P-04-582, and-P-04-
583
Chemical name: Polyhydroxyaminoether salts (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential) 
use of the substances will be for coated plastic bottle and film. Based 
on test data on analogous polycationic polymers, EPA predicts toxicity 
to aquatic organisms may occur at concentrations that exceed 10 ppb in 
surface waters. As described in the PMNs, the substances are not 
released into 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 
other uses resulting in release of the PMN substances to surface water 
may cause significant adverse environmental effects. Based on this 
information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 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 substances. Any of the consolidated chemicals may be used to 
conduct the testing. All studies should be performed using the static 
method with nominal concentrations.
CFR citation: 40 CFR 721.10114.
PMN Number P-04-625
Chemical name: 1-Hexadecanaminium, N,N-dibutyl-N-(2-hydroxyethyl)-, 
bromide (1:1).
CAS number: 160653-08-7.

[[Page 65751]]

Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a crude oil additive for downhole 
applications. Based on test data on structurally similar substances, 
EPA predicts toxicity to aquatic organisms may occur at concentrations 
that exceed 4 ppb 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 other uses of the substance resulting in release of 
the PMN substance to surface water 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 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. All studies should be performed using the static 
method with nominal concentrations.
CFR citation: 40 CFR 721.10115.
PMN Number P-04-758
Chemical name: Blocked polymeric isocyanate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a coating. Based on test data on 
analogous small and medium molecular-weight isocyanates, EPA has 
concerns for pulmonary sensitization and mutagenicity for the PMN 
material. As described in the PMN, significant worker exposure is 
unlikely, as neither dermal nor inhalation exposure is expected. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the PMN substance other than 
as described in the PMN may cause serious health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS 870.3465 test guideline) with a 60-day 
holding period would help characterize the health effects of the 
substance.
CFR citation: 40 CFR 721.10116.
PMN Number P-04-776
Chemical name: Heteromonocyclo-beta-(2,4-dichlorophenyl)-1-propanol 
(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 structurally analogous 
chemicals, EPA expects toxicity to aquatic organisms at surface water 
concentrations that exceed 100 ppb in surface waters. Also, based on 
test data on the PMN substance, EPA has concerns for liver toxicity and 
effects on the lungs, kidneys, and the GI tract. In addition, based on 
test data on structurally analogous chemicals, EPA has concerns for 
developmental toxicity. As described in the PMN, environmental releases 
are not expected as the substance is not released to surface waters. 
Although there is potential for inhalation and dermal exposures from 
use, based on analog data, the margin of exposure (MOE) of 100 is 
considered adequate. 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 other uses 
of the substance resulting in release of the PMN substance 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), 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)); a daphnid chronic toxicity test (OPPTS 850.1300 test guideline 
(public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 
test guideline (public draft)); and a prenatal developmental toxicity 
study (OPPTS 870.3700 test guideline) in rats would help characterize 
the human health and environmental effects of the PMN substance. All 
ecotox studies should be performed using the flow-through method with 
measured concentrations.
CFR citation: 40 CFR 721.10117.
PMN Number P-05-35
Chemical name: Substituted aryl acetonitrile (generic).
CAS number: Not available.
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 
analogous nitriles, EPA predicts toxicity to aquatic organisms may 
occur at concentrations that exceed 5 ppb in surface waters. As 
described in the PMN, the substance is not released into 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 other uses 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 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. The fish and daphnid tests should be performed using 
the flow thorough method with measured concentrations. The algal test 
should be preformed using the static method with measured 
concentrations.
CFR citation: 40 CFR 721.10118.
PMN Number P-05-673
Chemical name: Siloxane modified silica nanoparticles (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an additive. Based on t