[Federal Register: November 5, 2008 (Volume 73, Number 215)]
[Rules and Regulations]
[Page 65743-65766]
[DOCID:fr05no08-6]

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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: http://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<PHONE_NUMBER>. 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 http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or 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 http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
Federal holidays. The telephone number of the EPA/DC Public Reading
Room is<PHONE_NUMBER>, 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:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>    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:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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

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

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

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

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

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

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

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.

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 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, dermal and inhalation
exposures are not expected. Therefore, EPA has not determined that the
proposed manufacture, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that use without
impervious gloves or a NIOSH-approved respirator with an APF of at
least 10; the manufacture, process, or use of the substance as a
powder; or uses of the substance other than as described in the PMN may
cause serious health effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of 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 721.10119.
PMN Number P-05-687
Chemical name: Siloxane modified alumina 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 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 inhalation and
dermal exposure to the PMN substance. 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
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use without
impervious gloves or a NIOSH-approved respirator with an APF of at
least 10; the manufacture, process or use of the substance as a powder;
or uses of the substance other than as described in the PMN may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of 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 721.10120.
PMN Number P-05-766
Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-
methyl-.omega.-(4-nonylphenoxy)-, branched.
CAS number: 858944-25-9.
Basis for action: The PMN states that the generic (non-confidential
use) of the substance will be as a polyalkylene glycol lubricant
basefluid and additive. Based on test data on structurally similar
chemicals, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 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 substances 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
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 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
testing should be performed using the flow-through method with measured
concentrations. The algal testing should be performed using the static
method with measured concentrations.
CFR citation: 40 CFR 721.10121.
PMN Number P-06-151
Chemical name: 2-Propenoic acid, 2-methyl-, 1,1'-[2-ethyl-2-[[(2-
methyl-1-oxo-2-propen-1-yl)oxy]methyl]- 1,3-propanediyl] ester, polymer
with 1,3-butadiene, ethenylbenzene and 2-hydroxyethyl 2-methyl-2-
propenoate.
CAS number: 849925-18-4.
Basis for action: The PMN states that the substance will be used as an
additive in rubber, i.e. as a reinforcing agent. 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, significant worker exposure
is unlikely, as dermal and inhalation exposures are not expected.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as
described in the PMN may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(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 human health effects of the
PMN substance. This study should include observation of the entire
body, rather than just the lungs.
CFR citation: 40 CFR 721.10122.
PMN Number P-06-554
Chemical name: [1,2,4-Triazolo[1,5-a]pyrimidin-2-amine, 5,7-dimethoxy-
].
CAS number: 13223-43-3.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a process intermediate. 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 PMN, releases of the substance 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 substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in surface water concentrations that exceed 5 ppb may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an aquatic
invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010
test guideline (public draft)) using the flow-through method with
measured concentrations would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10123.
PMN Number P-06-617
Chemical name: Brominated polyaromatic compound (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a chemical intermediate. Based on test
data on polybrominated diphenyls and polybrominated diphenylethers, the
Agency identified human health concerns for liver and kidney toxicity,
mutagenicity, carcinogenicity, developmental toxicity, neurotoxicity,
reproductive toxicity, and possible chloracne from inhalation or dermal
exposure to the PMN substance. In addition, 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). 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. As described in the PMN, significant worker exposure is
unlikely due to adequate dermal protection and negligible inhalation
exposure, and environmental exposure is unlikely as 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 PMN substance without

the use of impervious gloves, any use of the PMN substance other than
as an intermediate, or 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)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of tiered
testing as described in the New Chemicals Program's PBT Category (64 FR
60194; November 4, 1999); a fish acute toxicity test (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)); an acute oral toxicity (OPPTS 870.1100 test
guideline); a bacterial reverse mutation test (OPPTS 870.5100 test
guideline); a mammalian erythrocyte micronucleus test by the
intraperitoneal route (OPPTS 870.5395 test guideline); a 90-day oral
toxicity test in rodents (OPPTS 870.3100 test guideline); and a
prenatal developmental toxicity study (OPPTS 870.3700 test guideline)
would help characterize the PBT, health, and environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10124.
PMN Numbers P-06-665, P-06-666, P-06-667, P-06-668, P-06-669, and P-06-
670
Chemical name: Alkenedioic acid, dialkyl ester, reaction products with
polyaminocarbomonocycle and alkenoic acid alkyl ester (generic).
CAS number: Not available.
Basis for action: The consolidated PMN states that the generic (non-
confidential) use of the substances will be as a component of an
automotive coating. Based on test data on analogous chemicals, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb in surface waters. As described in the consolidated PMN,
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 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 ready biodegradability test (OPPTS 835.3100 test
guideline) would help characterize the environmental effects of the PMN
substances. The fish and daphnid tests should be performed using the
flow-through method with measured concentrations. The algal test should
be performed using the static method with measured concentrations. The
fish, daphnid, and algal studies should be conducted with a stock
solution neutralized to pH 7 by HCl.
CFR citation: 40 CFR 721.10125.
PMN Number P-06-689
Chemical name: Alkyl amino substituted triazine amino substituted
benezenesulfonic acid reaction product with naphthalenesulfonato azo
substituted phenyl azo substituted benzenesulfonic acid copper compound
(generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
dye for cellulosic fabric. Based on test data on analogous substances,
EPA has concerns for carcinogenicity and mutagenicity for the PMN
substance. As described in the PMN, significant worker exposure is
unlikely, as dermal and inhalation exposures are not expected.
Therefore, EPA has not determined that the proposed processing or use
of the substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture of the PMN substance 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 bacterial
reverse mutation test with the Prival modification (OPPTS 870.5100 test
guideline); a mammalian erythrocyte micronucleus test in mice through
the oral route of exposure (OPPTS 870.5395 test guideline); and a
carcinogenicity test (OPPTS 870.4200 test guideline) pending positive
results on either of the first two tests would help characterize the
human health effects of the PMN substance.
CFR citation: 40 CFR 721.10126.
PMN Number P-06-693
Chemical name: Alkenyl dimethyl betaine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a crude oil production chemical. Based
on test data on structurally similar analogs, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 50 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
50 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
substance other than as described in the PMN could result in surface
water concentrations that exceed 50 ppb 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.
CFR citation: 40 CFR 721.10127.
PMN Number P-06-752
Chemical name: Modified imidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an adhesive for electrical parts. Based
on test data for imidazoles and esters, 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 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
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)); 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 the environmental effects of the PMN
substance. The fish and daphnid testing should be performed using the
flow-through method with measured concentrations. The algal testing
should be conducted using the static method with measured
concentrations.
CFR citation: 40 CFR 721.10128.
PMN Number P-07-24
Chemical name: Alkylamine ethoxylated (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will be
as an emulsifier for oilfield application. Based on test data on the
PMN substance and on structurally similar analogs, EPA predicts
toxicity to aquatic organisms may occur at concentrations that exceed 3
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 3 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
substance other than as described in the PMN could result in surface
water concentrations that exceed 3 ppb which may cause significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec.  721.170 (b)(4)(i) and
(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 (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 substance. The ready biodegradability test should be conducted
first. The results of this test may mitigate the need for further
testing. For the fish, daphnid and algal testing, the substance should
be tested as the chloride salt at pH 7.
CFR citation: 40 CFR 721.10129.
PMN Number P-07-140
Chemical name: Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-ar-[4-[[2-
(sulfooxy)ethyl]substituted]phenyl]-, monosodium salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of this substance will be as a colorant raw material. Based on test
data on analogous respirable, poorly soluble, particulates, EPA
predicts the PMN substance may cause lung effects. As described in the
PMN, significant worker exposure is unlikely, as dermal exposure is not
expected and significant inhalation exposure to the PMN substance is
not expected. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the
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
observations for a cancer potential would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10130.
PMN Number P-07-205
Chemical name: Isononanamide, N-(2-ethylhexyl)-.
CAS number: 93820-33-8.
Basis for action: The PMN states that the use of the substance will be
as a defoamer for cement additives in oilfield applications. Based on
test data on the PMN substance and on structurally similar analogous
neutral organic compounds, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 1 ppb in surface waters. For
the use described in the PMN, releases of the PMN substance to surface
waters are not expected to result in concentrations exceeding 1 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as
described in the PMN could result in surface water concentrations that
exceed 1 ppb which may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170 (b)(4)(i) 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)); 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
testing should be performed using the flow-through method with measured
concentrations. The algal testing should be performed using the static
method with measured concentrations.
CFR citation: 40 CFR 721.10131.
PMN Number P-07-269
Chemical name: Phosphoramidic acid, carbomonocyclic-, diphenylester
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a flame-resisting material used in
cars. Based on test data on the PMN substance, EPA has concerns for
liver toxicity in humans for the PMN material. Also, based on test data
on analogous triphenyl phosphates, EPA believes the PMN substance may
cause delayed neurotoxicity in humans. As described in the PMN,
significant worker or consumer exposure is unlikely, as dermal and
inhalation exposures are not expected. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, increased importation or production volumes, or uses other
than as described in the PMN may result in increased exposure to the
PMN substance which may cause serious health effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity study in rodents (OPPTS 870.3100 test guideline) via the
oral-gavage route and an acute and 28-day delayed neurotoxicity of
organophosphorus substances study (OPPTS 870.6100 test guideline) in
hens would help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10132.
PMN Number P-07-401
Chemical name: 2-Propenoic acid, 2-methyl, 2-hydroxyethyl ester,
homopolymer.
CAS number: 25249-16-5.
Basis for action: The PMN states that the generic (non-confidential)
use of the

substance will be as a matrix for an analysis device. Based on test
data on analogous high molecular weight polymers, the PMN substance may
cause lung toxicity and cancer. As described in the PMN, worker
inhalation exposure will be minimal due to 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 other than as described in the PMN, use without workers
wearing a NIOSH-approved respirator with an assigned protection factor
(APF) of 1,000 or greater, or use without an appropriate hazard
communication program 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 study (OPPTS 870.3465 test guideline) with a 60-day
holding period would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.10133.

IV. Objectives and Rationale of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 4 of the 56
chemical substances, regulation was warranted under section 5(e) of
TSCA, pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. The basis for such findings is outlined in Unit
III. Based on these findings, TSCA section 5(e) consent orders
requiring the use of appropriate exposure controls were negotiated with
the PMN submitters; the SNUR provisions for these chemical substances
listed in this document are consistent with the provisions of the TSCA
section 5(e) consent orders. These SNURs are promulgated pursuant to 40
CFR 721.160.
    In the other 52 cases for which the proposed uses are not regulated
under a TSCA section 5(e) consent order, EPA determined that one or
more of the criteria of concern established at 40 CFR 721.170 were met,
as discussed in Unit III.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
    1. EPA will receive notice of any person's intent to manufacture,
import, or process a listed chemical substance for the described
significant new use before that activity begins.
    2. EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
    3. EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
    4. EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Inventory. Guidance on how
to determine if a substance is on the TSCA Inventory is available on
the Internet at http://www.epa.gov/opptintr/newchems/pubs/invntory.htm.

V. Direct Final Procedures

    EPA is issuing these SNURs as a direct final rule, as described in
40 CFR 721.160(c)(3) and 721.170(d)(4)(B). In accordance with 40 CFR
721.160(c)(3)(ii) and 721.170(d)(4)(i)(B), this rule will be effective
[January 5, 2009], unless EPA receives a written notice by [December 5,
2008] of adverse or critical comments, or notice of intent to submit
adverse or critical comments, on EPA's action. If EPA receives such a
notice, EPA will publish a document to withdraw the direct final SNUR
for the specific chemical substance(s) to which the adverse or critical
comments apply. EPA will then propose a SNUR for the specific chemical
substance providing a 30-day comment period.
    This action establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments or notice of intent
to submit adverse or critical comments, must identify the chemical
substance and the new use to which it applies. EPA will not withdraw a
SNUR for a chemical substance not identified in a notice.

VI. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. Persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them. However,
upon review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. In cases where EPA issued a TSCA section 5(e)
consent order that requires or recommends certain testing, Unit III.
lists those tests. Unit III. also lists recommended testing for non-
5(e) SNURs. Descriptions of tests are provided for informational
purposes. EPA strongly encourages persons, before performing any
testing, to consult with the Agency pertaining to protocol selection.
Many test guidelines are now available on the Internet at http://
www.epa.gov/opptsfrs/home/guidelin.htm.
    In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These production limits
cannot be exceeded unless the PMN submitter first submits the results
of toxicity tests that would permit a reasoned evaluation of the
potential risks posed by these chemical substances. Under recent
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier consent orders required submissions at least 12
weeks) before reaching the specified production limit. Listings of the
tests specified in the TSCA section 5(e) consent orders are included in
Unit III. The SNURs contain the same production volume limits as the
consent orders. Exceeding these production limits is defined as a
significant new use. Persons who intend to exceed the production limit
must notify the Agency by submitting a SNUN at least 90 days in
advance.
    The recommended tests may not be the only means of addressing the
potential risks of the chemical substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under TSCA section 5(e), particularly if
satisfactory test results have not been obtained from a prior
submitter. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:

    1. Human exposure and environmental release that may result from
the significant new use of the chemical substances.
    2. Potential benefits of the chemical substances.
    3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.

VII. Procedural Determinations

    EPA is establishing through this rule certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2. EPA is required to keep this information
confidential to protect the CBI of the original PMN submitter. EPA
promulgated a procedure to deal with the situation where a specific
significant new use is CBI. This procedure appears in 40 CFR
721.1725(b)(1) and is similar to that in Sec.  721.11 for situations
where the chemical identity of the chemical substance subject to a SNUR
is CBI. This procedure is cross-referenced in each of these SNURs that
include specific significant new uses that are CBI.
    A manufacturer, importer, or processor may request EPA to determine
whether a proposed use would be a significant new use under this rule.
Under the procedure in Sec.  721.1725(b)(1), a manufacturer, importer,
or processor must show that it has a bona fide intent to manufacture,
import, or process the chemical substance and must identify the
specific use for which it intends to manufacture, import, or process
the chemical substance. If EPA concludes that the person has shown a
bona fide intent to manufacture, import, or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers, importers, and
processors can combine the bona fide submission under the procedure in
Sec.  721.1725(b)(1) with that under Sec.  721.11 into a single step.
    If a manufacturer, importer, or processor is told that the
production volume identified in the bona fide submission would not be a
significant new use, i.e., it is below the level that would be a
significant new use, that person can manufacture, import, or process
the chemical substance as long as the aggregate amount does not exceed
that identified in the bona fide submission to EPA. If the person later
intends to exceed that volume, a new bona fide submission would be
necessary to determine whether that higher volume would be a
significant new use. EPA is considering whether to adopt a special
procedure for use when CBI production volume is designated as a
significant new use. Under such a procedure, a person showing a bona
fide intent to manufacture, import, or process the chemical substance,
under the procedure described in Sec.  721.11, would automatically be
informed of the production volume that would be a significant new use.
Thus, the person would not have to make multiple bona fide submissions
to EPA for the same chemical substance to remain in compliance with the
SNUR, as could be the case under the procedures in Sec.
721.1725(b)(1).

VIII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule

    To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. TSCA section 5(e) consent
orders have been issued for 4 chemical substances and notice submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received an NOC and the chemical substance has not
been added to the TSCA Inventory, no other person may commence such
activities without first submitting a PMN. For chemical substances for
which an NOC has not been submitted at this time, EPA has concluded
that the uses are not ongoing. However, EPA recognizes in cases when
chemical substances identified in this SNUR are added to the TSCA
Inventory prior to the effective date of the rule, the chemical
substances may be manufactured, imported, or processed by other persons
for a significant new use as defined in this rule before the effective
date of the rule. However, 38 of the 56 chemical substances contained
in this rule have CBI chemical identities, and since EPA has received a
limited number of post-PMN bona fide submissions (per 40 CFR 720.25 and
721.11), the Agency believes that it is highly unlikely that any of the
significant new uses described in the following regulatory text are
ongoing. EPA solicits comments on whether any of the uses described as
significant new uses are ongoing.
    As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is
best served by designating a use as a significant new use as of the
date of publication of this direct final rule rather than as of the
effective date of the rule. If uses begun after publication were
considered ongoing rather than new, it would be difficult for EPA to
establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
final, and then argue that the use was ongoing as of the effective date
of the final rule. Thus, persons who begin commercial manufacture,
import, or processing of the chemical substances regulated through this
SNUR will have to cease any such activity before the effective date of
this rule. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
    EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec.  721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities.

IX. SNUN Submissions

    EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50.
    SNUNs must be mailed to the Environmental Protection Agency, OPPT
Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40).
Forms and information are also available electronically at http://
www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete

economic analysis is available in the public docket.

XI. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that proposed or final SNURs are not a
``significant regulatory action'' subject to review by OMB, because
they do not meet the criteria in section 3(f) of the Executive order.

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
    The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 574). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of these SNURs will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. The requirement to submit a SNUN applies to
any person (including small or large entities) who intends to engage in
any activity described in the rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of over 1,000 SNURs, the Agency
receives on average only 5 notices per year. Of those SNUNs submitted
from 2005-2007, none appear to be from small entities. In addition, the
estimated reporting cost for submission of a SNUN (see Unit IX.), are
minimal regardless of the size of the firm. Therefore, EPA believes
that the potential economic impacts of complying with these SNURs are
not expected to be significant or adversely impact a substantial number
of small entities. In a SNUR that published on June 2, 1997 (62 FR
29684) (FRL-5597-1), the Agency presented its general determination
that proposed and final SNURs are not expected to have a significant
economic impact on a substantial number of small entities, which was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rulemaking.
As such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).

E. Executive Order 13132

    This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This does
not significantly or uniquely affect the communities of Indian Tribal
governments, nor does it involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.

I. National Technology Transfer and Advancement Act

    In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

K. Executive Order 12630

    EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 18, 1988), by examining the takings
implications of this rule in accordance with the ``Attorney General's
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings'' issued under the Executive order.

L. Executive Order 12988

    In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).

XII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a final rule may take effect, the agency
promulgating it must submit a final rule report to each House of the
Congress and to the Comptroller General of the United States. EPA will
submit a report containing this final rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the final rule in the Federal Register. This final rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: October 30, 2008.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

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Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

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

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

0
2. By adding new Sec.  721.10089 to subpart E to read as follows:

Sec.  721.10089  Modified salicylic acid, zirconium complex (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified salicylic acid, zirconium complex (PMN P-00-552) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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3. By adding new Sec.  721.10090 to subpart E to read as follows:

Sec.  721.10090  Tertiary amine salt of glycol succinate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
tertiary amine salt of glycol succinate (PMN P-01-595) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k).
    (A) Restricting the manufacture of the PMN substance with only
those feedstocks specified in the PMN submission.
    (B) Manufacture, import, or processing of the PMN substance without
analyzing representative samples of the chemical substance to determine
compliance with the requirements in Sec.  721.10090(a)(2)(i)(A). To
ensure compliance, the PMN substance must be analyzed (1) at the time
of initial commencement of non-exempt commercial manufacture of the
chemical substance, and (2) at least annually thereafter during every
year in which the substance is manufactured.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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4. By adding new Sec.  721.10091 to subpart E to read as follows:

Sec.  721.10091  2(1H)-Pyrimidinone, tetrahydro-1,3-dimethyl-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2(1H)-pyrimidinone,
tetrahydro-1,3-dimethyl- (PMN P-02-135; CAS No. 7226-23-5) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3)(i), (b), and (c). Best's Viton model
890, Best's Butyl model 874, and Best's Butyl
878 have been demonstrated to satisfy Sec.  721.63(a)(3)(i).
Other demonstrated impervious gloves that satisfy Sec.  721.63(a)(3)(i)
are permissible.
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (f), (j) (aprotic solvent and catalyst),
and (s) (20,000 kg).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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5. By adding new Sec.  721.10092 to subpart E to read as follows:

Sec.  721.10092  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).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 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) (PMN P-02-421; CAS
Nos. 352661-91-7 and 224646-44-0) is

subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) (no manufacture or import of 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). Representative samples of the PMN substance
must be analyzed and determined to comply with these requirements both
at the time of initial commencement and annually thereafter.
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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6. By adding new Sec.  721.10093 to subpart E to read as follows:

Sec.  721.10093  Alkylamides, ethoxylated (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkylamides, ethoxylated (PMNs P-03-12 and P-03-13) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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7. By adding new Sec.  721.10094 to subpart E to read as follows:

Sec.  721.10094  Decene, branched and linear.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as decene, branched
and linear (PMN P-03-272; CAS No. 833482-31-8) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Record keeping requirements as specified in
Sec.  721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

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8. By adding new Sec.  721.10095 to subpart E to read as follows:

Sec.  721.10095  Oxetane, 3,3'-[oxybis(methylene)] bis[3-ethyl-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxetane, 3,3'-
[oxybis(methylene)] bis[3-ethyl- (PMN P-03-471; CAS No. 18934-00-4) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(iii), and (a)(3) (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 Sec.
721.63(a)(3)(i) for up to 8 hours.
    (ii) Hazard communication program. Requirements as specified in
Sec.  721.72 (a), (b), (c), (d), (e), (f), (g)(1)(iv), (g)(1)(v), and
(g)(2)(v).
    (iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable
to manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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9. By adding new Sec.  721.10096 to subpart E to read as follows:

Sec.  721.10096  Benzene, 1,4-bis (methoxymethyl)-.

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 1,4-bis
(methoxymethyl)- (PMN P-03-614; CAS No. 6770-38-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(q).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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10. By adding new Sec.  721.10097 to subpart E to read as follows:

Sec.  721.10097  Disubstituted benzenesulfonic acid, alkali metal salt
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
disubstituted benzenesulfonic acid, alkali metal salt (PMN P-03-642) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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11. By adding new Sec.  721.10098 to subpart E to read as follows:

Sec.  721.10098  Disubstituted benzoic acid, alkali metal salt
(generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
disubstituted benzoic acid, alkali metal salt (PMN P-03-643) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(j).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.

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12. By adding new Sec.  721.10099 to subpart E to read as follows:

Sec.  721.10099  Dialkyl dimethyl ammonium carbonate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dialkyl
dimethyl ammonium carbonate (1:1) (PMN P-03-715) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) (N = 5).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
13. By adding new Sec.  721.10100 to subpart E to read as follows:

Sec.  721.10100  Dialkyl dimethyl ammonium carbonate (2:1) (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dialkyl
dimethyl ammonium carbonate (2:1) (PMN P-03-716) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Release to water. Requirements as specified in Sec.  721.90
(a)(4), (b)(4), and (c)(4) (N = 5).
    (ii) [Reserved]
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.

0
14. By adding new Sec.  721.10101 to subpart E to read as follows:

Sec.  721.10101  Copolymer of alkyl acrylate and ethyleneglycol
dimethacrylate (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
copolymer of alkyl acrylate and ethyleneglycol dimethacrylate (PMN P-
03-755) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6)(i), (a)(6)(ii), (b), and (c). The
following National Institute for Occupational Safety and Health
(NIOSH)-approved respirators with an assigned protection factor (APF)
of 10-25 meet the minimum requirements for Sec.  721.63(a)(4): Air-
purifying, tight-fitting respirator equipped with N100 (if oil aerosols
absent), R100, or P100 filters (either half- or full-face); powered
air-purifying respirator equipped with a loose-fitting hood or helmet
and High Efficiency Particulate Air (HEPA) filters; powered air-
purifying respirator equipped with a tight-fitting facepiece (either
half- or full-face) and HEPA filters; and supplied-air respirator
operated in pressure demand or continuous flow mode and equipped with a
hood or helmet, or tight-fitting facepiece (either half- or full-face).