[Federal Register Volume 72, Number 60 (Thursday, March 29, 2007)]
[Rules and Regulations]
[Pages 14681-14708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5797]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2003-0063; FRL-7699-5]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances and
Notification on Certain Substances for Which Significant New Use Rules
are Not Being Issued
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 65
chemical substances which were the subject of premanufacture notices
(PMNs). Thirteen 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 65 chemical
substances for an activity that is designated as a significant new use
by this rule to notify
[[Page 14682]]
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. This direct final rule also provides notification on
two substances for which EPA has decided not to issue significant new
use rules at this time.
DATES: The effective date of this rule is May 29, 2007 without further
notice, unless EPA receives adverse or critical comments, or notice of
intent to submit adverse or critical comments before April 30, 2007.
This rule shall be promulgated for purposes of judicial review at 1
p.m. (e.s.t.) on April 12, 2007.
If EPA receives adverse or critical comments, or notice of intent
to submit adverse or critical comments, on one or more of these SNURs
before April 30, 2007, 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-2003-0063, 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 Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2003-0063. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2003-0063. 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's
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 (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
For technical information contact: Karen Chu, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8773; e-mail
address: [email protected].
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
[[Page 14683]]
that is the subject of this rule on or after April 30, 2007 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 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 part
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, the Agency
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 on 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 65 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 section 5(e) consent order, or, for non-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
listed in the regulatory text section of 40 CFR part 721, subpart E.
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 13 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.
The 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. The SNURs designate as a ``significant new
use'' the absence of the protective measures required in the consent
order.
Where EPA determined that the PMN substance may present an
unreasonable risk of injury to human health via
[[Page 14684]]
inhalation exposure, the underlying 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 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 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 are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order for the same
chemical substance for SNURs.
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 section 5(e) of TSCA. 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-97-415
Chemical name: 2-Thiazolidinone.
CAS number: 2682-49-7.
Effective date of section 5(e) consent order: April 20, 2000.
Basis for section 5(e) consent order: The PMN states that the substance
will be used as an intermediate. The order was issued under section
5(e)(1)(A)(i) and (ii)(I) of TSCA based on a finding that this
substance may present an unreasonable risk of injury to health and the
environment. To protect against this risk, the consent order requires
worker protection and hazard communication and restricts disposal,
water releases, and aggregate manufacture/importation volume of the PMN
substance. It also prohibits use of the PMN substance other than as an
intermediate and prohibits domestic manufacturing, processing, or use
of the PMN substance as a powder. The SNUR designates as a `significant
new use' the absence of these protective measures.
Toxicity concern: EPA has identified health concerns for high acute
toxicity and signs of neurotoxic effects based on test data for the PMN
substance. EPA also has concerns for chronic effects and systemic,
developmental, and maternal toxicity based on test data on a
structurally similar substance. The NCEL is 0.7 mg/m\3\ as an 8-hour
time-weighted average. EPA is concerned that toxicity to aquatic
organisms may occur at concentrations as low as 300 parts per billion
(ppb) of the PMN substance in surface waters based on test data on a
structurally similar substance.
Recommended testing: EPA has determined that the following test would
help characterize the human health effects of the PMN substance: A
combined repeated dose toxicity with the reproductive/developmental
toxicity screening test (oral route) (OPPTS 870.3650 test guideline)
with a neurotoxicity functional observational battery (National
Technical Information Service (NTIS) PB 91-154617) and a
histopathologic examination extended to include the blood, liver,
kidney, brain, and spinal cord on the PMN substance to help
characterize neurotoxic, systemic, reproductive, and developmental
effects. The PMN submitter has agreed not to exceed the production
volume limit without performing this test. In addition, EPA has
determined that a porous pot test (OPPTS 835.3220 test guideline), a
fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10002.
PMN Numbers P-98-625/626/627/628/629 and P-00-614/617
Chemical name: Manganese heterocyclic tetraamine complex (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential)
use of the substances will be in commercial research and development.
EPA has identified health concerns for chronic organ effects based on
data on a structurally similar substance. Since significant worker
exposure is unlikely at the production volume identified in the PMNs,
EPA has not determined that the proposed manufacture, processing, or
use of the substances may present an unreasonable risk. EPA has
determined, however, that a manufacture or importation volume greater
than 10,000 kilograms/year of any one of the PMN substances may result
in serious chronic effects. Based on this information, each of the PMN
substances meet the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day
oral toxicity study (OPPTS 870.3100 test guideline) would help
characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.10003.
PMN Number P-98-1181
Chemical name: 2-Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C8-10-isoalkyl esters, C9-rich.
CAS number: 247041-56-1.
Basis for action: The PMN states that the substance will be used as a
polyvinyl chloride stabilizer. EPA has identified concerns for
corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood
toxicity, liver toxicity, immunosupression, reproductive toxicity, and
adrenal effects based on analogy to organotins. As described in the
PMN, significant worker exposure is unlikely. 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 uses of the substance in a solid form, involving an
application method that generates a vapor, mist, or aerosol, or where
there is potential dermal exposure without the use of impervious
gloves, 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
[[Page 14685]]
oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity
screening test (OPPTS 870.6200 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10004.
PMN Number P-98-1182
Chemical name: 2-Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C9-11-isoalkyl esters, C10-rich.
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
polyvinyl chloride stabilizer. EPA has identified concerns for
corrosion to skin, eyes, and mucuous membranes, neurotoxicity, blood
toxicity, liver toxicity, immunosupression, reproductive toxicity, and
adrenal effects based on analogy to organotins. As described in the
PMN, significant worker exposure is unlikely. 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 uses of the substance in a solid form, involving an
application method that generates a vapor, mist, or aerosol, or where
there is potential dermal exposure without the use of impervious
gloves, 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
oral toxicity study (OPPTS 870.3100 test guideline) and a neurotoxicity
screening test (OPPTS 870.6200 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10005.
PMN Number P-99-511
Chemical name: Mixed metal oxide (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an
additive for coatings. Based on data for a similar substance, EPA has
identified concerns for cancer, immunotoxicity, and lung toxicity. As
described in the PMN, significant inhalation exposure is unlikely.
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 a manufacture/importation volume
greater than 60,000 kilograms/year 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 a bacterial reverse
mutation test (OPPTS 870.5100 test guideline) and a mammalian
erythrocyte micronucleus test (intraperitoneal route) (OPPTS 870.5395
test guideline) with special attention to histopathology of the lung
tissues and organs of the immune systems (spleen, thymus, bone marrow)
would help characterize the human health effects of the PMN substance.
If the results of the recommended tests indicate that the PMN substance
has carcinogenic potential, a carcinogenicity study (OPPTS 870.4200
test guideline) would help further characterize the health effects.
CFR citation: 40 CFR 721.10006.
PMN Number P-00-11
Chemical name: Alcohols, C12-14 - secondary, ethoxylated
propoxylated.
CAS number: 103331-86-8.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a household cleaning agent additive.
Based on analogy to nonionic surfactants, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations above 50 ppb
in surface waters. As described in the PMN, releases of the substance
are not expected to result in surface water concentrations above 50
ppb. Thus, 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 above 50 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 a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity test (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10007.
PMN Numbers P-00-1121/1122/1123/1124/1125/1126
Chemical names: (P-00-1121) Manganese strontium oxide
(MnSrO3); (P-00-1122) Manganese yttrium oxide
(MnYO3); (P-00-1123) Barium manganese oxide
(BaMnO3); (P-00-1124) Barium calcium manganese strontium
oxide; (P-00-1125) Manganate (MnO2\1\-), calcium
(2:1); and (P-00-1126) Manganese yttrium oxide
(Mn2YO5).
CAS numbers: (P-00-1121) 12163-45-0, (P-00-1122) 12032-75-6, (P-00-
1123) 12230-80-7, (P-00-1124) 359427-90-0, (P-00-1125) 12049-47-7, and
(P-00-1126) 12438-71-0.
Effective date of section 5(e) consent order: March 23, 2001.
Basis for section 5(e) consent order: The PMNs state that the generic
(non-confidential) use of the substances will be as pigments. The order
was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA
based on a finding that these substances may present an unreasonable
risk of injury to human health and the environment. To protect against
this risk, the consent order requires hazard communication and
restricts aggregate manufacture/importation volume, particle size and
water releases of the PMN substances. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: EPA has health concerns for neurotoxicity and
mutagenicity for the PMN substances based on exposure to manganese;
concerns for lung toxicity, fibrosis, and possible cancer of the lungs
due to potential exposure to the particulate form of the substances;
and concern for lung effects through lung overload if respirable
particles are inhaled. Based on test data on structurally similar
substances, EPA is concerned that toxicity to aquatic organisms for
each of these PMN substances may occur at concentrations as low as 100
ppb in surface waters. Further, the Agency has determined that the PMN
substances may be persistant, bioaccumulative, and toxic based on
physical/chemical properties of the substances, consistent with the New
Chemical Program's Persistant, Bioaccumulative, and Toxic (PBT)
Category (64 FR 60194, November 4, 1999) (FRL-6097-7). Because of the
potential PBT nature of the PMN substances, bioaccumulation and the
potential for eventual exposure to humans and wildlife could result
from exposure to concentrations below 100 ppb. Therefore, to adequately
mitigate this concern, EPA has decided to limit surface water
concentrations resulting from manufacturing, processing, or use to 1
ppb or less for each of the PMN substances.
Recommended testing: EPA has determined that a fish bioconcentration
factor (BCF) test (OPPTS 850.1730 test guideline (public draft)) would
help characterize the environmental effects of the substances. The PMN
submitter has
[[Page 14686]]
agreed not to exceed the production volume limit without performing the
fish BCF test on P-00-1122 or P-00-1126. EPA has determined that a 90-
day inhalation toxicity study in rats with a 60-day holding period with
special attention to the histopathology of the lungs (OPPTS 870.3465
test guideline) would help characterize the human health effects of the
PMN substances. Based on the results of the 90-day study, a 2-year
inhalation carcinogenicity test (OPPTS 870.4200 test guideline) may be
warranted.
CFR citations: 40 CFR 721.10008 (P-00-1121); 40 CFR 721.10009 (P-00-
1122); 40 CFR 721.10010 (P-00-1123); 40 CFR 721.10011 (P-00-1124); 40
CFR 721.10012 (P-00-1125); and 40 CFR 721.10013 (P-00-1126).
PMN Number P-01-109
Chemical name: Halogenated naphthalic anhydride (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
dye intermediate. Based on toxicity data on structurally similar
chemicals, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 20 ppb of the PMN substance in surface waters.
As described in the PMN, the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed processing
or use of the substance may present an unreasonable risk. EPA has
determined, however, that releases to surface waters may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following testing would help characterize the PMN substance: An algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), a daphnid
acute toxicity test (OPPTS 850.1010 test guideline (public draft)), and
a fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)).
CFR citation: 40 CFR 721.10014.
PMN Number P-01-110
Chemical name: Halogenated benzimidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
dye intermediate. Based on Structure Activity Relationships (SAR)
analysis, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 1 ppb of the PMN substance in surface waters.
In addition, EPA has identified environmental concerns because the PMN
substance may be persistent, bioaccumulative, and toxic based on
physical/chemical properties of the PMN substance, consistent with the
New Chemical Program's PBT Category (64 FR 60194, November 4, 1999). 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 of the PMN substance to surface waters may cause 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)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tiered testing would help characterize the PMN substance:
Tier 1 - Melting point/melting range test (OPPTS 830.7200 test
guideline) and an octanol water partition coefficient/Kow
test (OPPTS 830.7550 test guideline); Tier 2 - Activated sludge
sorption isotherm (OPPTS 835.1110 test guideline) or modified
coagulation-flocculation jar test of water (D2034-80); Tier 3 - An
algal toxicity test (OPPTS 850.5400 test guideline (public draft)), a
daphnid acute toxicity test (OPPTS 850.1010 test guideline (public
draft)) and a fish acute toxicity test (OPPTS 850.1075 test guideline
(public draft)); Tier 4 - tiered testing as described in the New
Chemicals Program's PBT Category (excluding the octanol water partition
coefficient/Kow test already recommended in Tier 1).
CFR citation: 40 CFR 721.10015.
PMN Number P-01-111
Chemical name: Dibenzimidazothianaphthalene (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
fluorescent dye. Based on toxicity data on structurally similar
chemicals, EPA expects chronic toxicity to aquatic organisms to occur
at concentrations as low as 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
processing or use of the substance may present an unreasonable risk.
EPA has determined, however, that releases to surface waters may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the
following tiered testing would help characterize the PMN substance:
Tier 1 - Activated sludge sorption isotherm test (OPPTS 835.1110 test
guideline) or modified coagulation-flocculation jar test of water
(D2034-80); Tier 2 - An algal toxicity test (OPPTS 850.5400 test
guideline (public draft)), a daphnid acute toxicity test (OPPTS
850.1010 test guideline (public draft)), and a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)); and Tier 3 - A daphnid
chronic toxicity test (OPPTS 850.1300 test guideline (public draft))
and a fish early-life stage toxicity test (OPPTS 850.1400 test
guideline (public draft)).
CFR citation: 40 CFR 721.10016.
PMN Numbers P-01-257/258/259 and P-01-261
Chemical name: Amine terminated bisphenol A diglycidyl ether polymer
(generic).
CAS number: Not available.
Basis for action: The PMNs state that the substances will be used as
epoxy resin curing agents. Based on analogy to structurally similar
polycationic polymers, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations as low as 40 ppb in surface
waters. As described in the 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 an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish
acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and
a fish acute toxicity test mitigated by humic acid (OPPTS 850.1085 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.10017.
PMN Number P-01-442
Chemical name: Calcium hydroxide oxide silicate
(Ca6(OH)2O2(Si2O5
)3).
CAS number: 13169-90-9.
Basis for action: The PMN states that the substance will be used as a
filler to reinforce resins, an additive for resins, and a filter
medium. Based on test data on this chemical and structurally similar
compounds, EPA has identified
[[Page 14687]]
human health concerns for cancer and toxicity to the respiratory tract,
lungs, respiratory system, and liver to workers exposed via inhalation.
As described in the PMN, significant worker exposure is unlikely.
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, uses other than as
described in the PMN, or processing or use as a powder resulting in
significant worker inhalation exposure may cause significant adverse
human health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(i),
and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test guideline) would help characterize
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10018.
PMN Number P-01-563
Chemical name: Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
CAS number: 174489-76-0.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate. Based on submitted test data and on structural
analogy to esters, EPA is concerned that toxicity to aquatic organisms
may occur at concentrations as low as 3 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that 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)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), and an
aerobic aquatic biodegradation test with an analytical methodology to
identify the isononyl phenol degradation product (OPPTS 835.3100 test
guideline) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10019.
PMN Number P-01-564
Chemical name: Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
CAS number: 174489-43-1.
Basis for action: The PMN states that the substance will be used as a
chemical intermediate. Based on structural analogy to anilines, EPA is
concerned that toxicity to aquatic organisms may occur at
concentrations as low as 1 ppb of the PMN substance in surface waters.
As described in the PMN, the substance is not released to surface
waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that 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 a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), and an
aerobic aquatic biodegradation test with an analytical methodology to
identify the isononyl phenol degradation product (OPPTS 835.3100 test
guideline) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10020.
PMN Number P-01-764
Chemical name: Magnesium potassium titanium oxide.
CAS number:39290-90-9.
Effective date of section 5(e) consent order: July 29, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a physical
characteristics modifier for industrial use in certain solid composite
articles. 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 worker protection and
hazard communication and restricts the aggregate manufacture/
importation volume of the PMN substance. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: Based on test data on titanium dioxide, EPA has
health concerns for lung toxicity, including lung overload and
oncogenicity, with inhalation exposure. The NCEL is 5 mg/m\3\ as an 8-
hour time-weighted average.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study with a 60-day holding period (OPPTS 870.3465
test guideline) and possibly a 2-year carcinogenicity study (OPPTS
870.4200 test guideline) would help characterize the human health
effects of the PMN substance. The consent order contains two production
volume limits. The PMN submitter agreed not to exceed the first
production volume limit without performing the 90-day inhalation
toxicity study and not to exceed the second production volume limit
without performing the 2-year carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10021.
PMN Numbers P-01-769/770/771/772
Chemical names: (P-01-769) Benzenamine, N-phenyl-, ar-(C9-
rich C8-10-branched alkyl) derivs; (P-01-770) Benzenamine,
N-phenyl-, ar, ar'-(C9-rich C8-10-branched alkyl)
derivs; (P-01-771) 10H-Phenothiazine, ar-(C9-rich
C8-10-branched alkyl) derivs; and (P-01-772) 10H-
Phenothiazine, ar, ar'-(C9-rich C8-10-branched
alkyl) derivs.
CAS numbers: (P-01-769) 333955-69-4, (P-01-770) 333955-70-7, (P-01-771)
333955-79-6, and (P-01-772) 333955-80-9.
Basis for action: The PMNs state that the substances will be used as
antioxidants for lubricating oils. EPA has identified human health and
environmental concerns because the PMN substances may be persistent,
bioaccumulative, and toxic, based on submitted test data and physical/
chemical properties of the PMN substances, consistent with the New
Chemical Program's PBT Category (64 FR 60194, November 4, 1999). As
described in the PMNs, significant worker exposure is unlikely and the
substances are not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
PMN substances may present an unreasonable risk. EPA has determined,
however, that use of the PMN substances other than as described in the
PMNs resulting in release to water may cause serious chronic human
health effects and significant environmental effects, since the PMN
substances have been characterized by EPA as a PBT. Based on this
information, the PMN substances meet the concern criteria at Sec.
721.170 (b)(3)(i), (b)(4)(ii), and (b)(4)(iii).
Recommended testing: EPA has determined that the results of testing
Tiers 2 and 3 as described in the New
[[Page 14688]]
Chemicals Program's PBT Category would help characterize the PBT
attributes of the PMN substances.
CFR citations: 40 CFR 721.10022 (P-01-769); 40 CFR 721.10023 (P-01-
770); 40 CFR 721.10024 (P-01-771); and 40 CFR 721.10025 (P-01-772).
PMN Number P-01-856
Chemical name: Cashew, nutshell liq., ethoxylated.
CAS number: 350820-95-0.
Effective date of section 5(e) consent order: July 5, 2002.
Basis for section 5(e) consent order: The PMN states that the substance
will be used as a pigment dispersant. 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 restricts
molecular weight and composition of the PMN substance. The SNUR
designates as a `significant new use' the absence of these protective
measures.
Toxicity concern: Based on test data on structurally similar nonionic
surfactants, particularly alkyl ethoxylate, EPA has concerns that the
environmental toxicity of the PMN substance varies depending on the
average number of moles of the ethoxy. As the number of moles of ethoxy
decreases, the aquatic toxicity of the substance increases. For this
PMN substance, the average number of moles may vary. When the average
number of moles of the ethoxy group is 80, EPA expects toxicity to
aquatic organisms to occur at concentrations as low as 1,000 ppb.
Recommended testing: The Agency has determined that the results of a
fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help characterize possible
environmental effects of the substance. The tests should be conducted
on the PMN substance with less than 55 moles of the ethoxy group or
with an average molecular weight less than 2,700 daltons.
CFR citation: 40 CFR 721.10026.
PMN Number P-01-862
Chemical name: Ethoxylated alkylsulfate, substituted alkylamine 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 processing aid. Based on analogy to
cationic surfactants and similar substances, EPA is concerned that
chronic toxicity to aquatic organisms may occur at concentrations as
low as 4 ppb of the PMN substance in surface waters. As described in
the PMN, the substance is not released to surface waters in significant
quantities. 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 significant 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 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 a ready biodegradability test (OPPTS 835.3110 test guideline) would
help characterize the chronic environmental effects and the fate in the
environment of the PMN substance. After this testing is completed, if
the results of the testing and projected environmental risk warrant it,
a porous pot test (OPPTS 835.3220 test guideline) or modified semi-
continuous activated sludge (SCAS) test (OPPTS 835.3210 test guideline)
would further characterize the environmental fate of this substance.
CFR citation: 40 CFR 721.10027.
PMN Numbers P-01-901 and P-01-902
Chemical name: Disubstituted benzene metal salt (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-confidential)
use of the substances will be as a polymer additive. Based on test data
and analogy to phenols and hydroquinones/quinones, EPA has concerns for
dermal corrosivity, acute toxicity, kidney and liver effects,
mutagenicity, carcinogenicity, neurotoxicity, developmental toxicity,
depigmentation of skin, thyroid effects, and sensitization. Also, based
on analogy to phenols and hydroquinones/quinones, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations as low as 1
ppb in surface waters. As described in the PMNs, significant worker
exposure is not expected as workers wear impervious personal protective
equipment and significant environmental exposure is not expected as the
substances are not released to surface waters in significant
quantities. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substances may present an
unreasonable risk. EPA has determined, however, that use of the
substances without workers wearing impervious gloves or uses other than
as described in the PMNs could result in serious health effects or
significant adverse environmental effects. Based on this information,
the PMN substances meet 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 an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN
substances. EPA has also determined that a 90-day inhalation toxicity
study with a 60-day holding period (OPPTS 870.3465 test guideline)
would help characterize the human health effects.
CFR citation: 40 CFR 721.10028.
PMN Number P-01-918
Chemical name: Isocyanate compound, modified with methoxysilane
(generic).
CAS number: Not available.
Effective date of section 5(e) consent order: May 30, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a sealant. 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 worker protection and hazard communication and restricts
the aggregate manufacture/importation volume of the PMN substance. The
SNUR designates as a `significant new use' the absence of these
protective measures.
Toxicity concern: Based on test data on diisocyanates, the Agency has
concern for dermal and respiratory sensitization and pulmonary
toxicity. The NCEL is 0.05 mg/m\3\ or 0.005 ppm as an 8-hour time-
weighted average.
Recommended testing: EPA has determined that the results of a skin
sensitization study (OPPTS 870.2600 test guideline) and a 90-day
inhalation toxicity study (OPPTS 870.3465 test guideline) would help
characterize the human health effects of the substance.
CFR citation: 40 CFR 721.10029.
PMN Number P-01-919
Chemical name: Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-
methylbenzenesulfonate, base-hydrolyzed.
[[Page 14689]]
CAS number: 346709-25-9.
Basis for action: The PMN states that the substance will be used as a
pigment for thermoplastic polymers. Based on analogy to structurally
similar N-heterocyclic chemicals, EPA has concerns for potential
developmental toxicity from exposure to the PMN material. Significant
worker exposure is unlikely when the substance is used as described in
the PMN. In addition, based on test data on the PMN substance, EPA is
concerned that chronic toxicity to aquatic organisms may occur at
concentrations as low as 10 ppb in surface waters. As described in the
PMN, the substance is not released to surface waters in significant
quantities. 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 domestic
manufacture of the substance may cause serious health effects and
significant environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and
(b)(4)(i).
Recommended testing: EPA has determined that a combined repeated dose
toxicity study with the reproduction/developmental toxicity screening
test (OPPTS 870.3650 test guideline), a daphnid chronic toxicity test
(OPPTS 850.1300 test guideline (public draft)), and a fish early-life
stage toxicity test (OPPTS 850.1400 test guideline (public draft))
would help characterize the human health and environmental effects of
the substance.
CFR citation: 40 CFR 721.10030.
PMN Number P-02-214
Chemical name: Lithium potassium titanium oxide.
CAS number: 39318-30-4.
Effective date of section 5(e) consent order: June 17, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a physical
characteristics modifier for industrial use in certain solid composite
articles. 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 worker protection and
hazard communication and restricts the aggregate manufacture/
importation volume of the PMN substance. The SNUR designates as a
`significant new use' the absence of these protective measures.
Toxicity concern: Based on test data on titanium dioxide, the Agency
has concerns for lung toxicity (including oncogenicity) if the PMN
substance is inhaled. The NCEL is 5 mg/m\3\ as an 8-hour time-weighted
average.
Recommended testing: EPA has determined that the results of a 90-day
inhalation toxicity study with a 60-day holding period (OPPTS 870.3465
test guideline) and possibly a 2-year carcinogenicity study (OPPTS
870.4200 test guideline) would help characterize the human health
effects of the PMN substance. The consent order contains two production
volume limits. The PMN submitter agreed not to exceed the first
production volume limit without performing the 90-day inhalation
toxicity study and not to exceed the second production volume limit
without performing the 2-year carcinogenicity study if warranted based
on the results of the first study.
CFR citation: 40 CFR 721.10031.
PMN Number P-02-269
Chemical name: Acrylic acid, polymer with substituted acrylamides
(generic).
CAS number: Not available.
Effective date of section 5(e) consent order: October 22, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a thermo-sensitive
water absorbing/desorbing polymer to soil. 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 restricts the
particle size of the PMN substance. The SNUR designates as a
`significant new use' the absence of this protective measure.
Toxicity concern: Based on test data on swellable high molecular weight
polymers (see 60 FR 16319-16320, March 29, 1995) (FRl-4921-9), the
Agency has concerns for lung toxicity and oncogenicity if the PMN
substance is inhaled.
Recommended testing: The Agency has determined that a 90-day inhalation
toxicity study (OPPTS 870.3465 test guideline) and a carcinogenicity
study (OPPTS 870.4200 test guideline) would help characterize possible
human health effects of the substance.
CFR citation: 40 CFR 721.10032.
PMN Number P-02-322
Chemical name: Zinc, [ethanedioato(2-)-. kappa. O\1\, . kappa. O\2\]-.
CAS number: 547-68-2.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an intermediate. Based on analogy to
similar zinc compounds, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations above 1 ppb in surface waters. As
described in the PMN, releases of the substance are not expected to
result in surface water concentrations above 1 ppb. Therefore, EPA has
not determined that the proposed manufacturing, processing, or use of
the PMN substance may cause significant adverse effects. EPA has
determined, however, that other uses of the PMN substance resulting in
surface water concentrations above 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), 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.
CFR citation: 40 CFR 721.10033.
PMN Number P-02-359
Chemical name: Substituted pyridine coupled with diazotized substituted
nitrobenzonitrile, diazotized substituted benzenamine and substituted
pyridinecarbonitrile (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a textile dye. Based on structural
analogy to neutral organics, EPA is concerned that chronic toxicity to
aquatic organisms may occur at concentrations above 1 ppb of the PMN
substance in surface waters. As described in the PMN, the substance is
not released to surface waters in significant quantities. 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 in concentrations above 1 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish early-life 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 (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10034.
PMN Number P-02-382
Chemical name: Alkylbenzene sulfonate (generic).
[[Page 14690]]
CAS number: Not available.
Effective date of section 5(e) consent order: December 17, 2002.
Basis for section 5(e) consent order: The PMN states that the generic
(non-confidential) use of the substance will be as a petroleum
lubricant 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 restricts the formulation of the
PMN substance. The SNUR designates as a `significant new use' the
absence of this protective measure. In addition, the order was issued
under section 5(e)(1)(A)(ii)(II) of TSCA based on a finding that this
substance will be produced in substantial quantities and may reasonably
be anticipated to enter the environment in substantial quantities.
Toxicity concern: Based on analogy to structurally similar anionic
surfactants, EPA expects toxicity to aquatic organisms to occur at
concentrations as low as 500 ppb in surface waters. However, when the
PMN substance is manufactured, processed, and used in mineral oil as
described in the PMN, EPA does not expect releases of this PMN
substance to pose a risk to the environment. The oil diluent serves to
minimize dispersion and bioavailability of the PMN substance in surface
waters. EPA has determined that other uses of the substance when not
diluted in mineral oil may result in significant release to surface
waters and may cause significant adverse environmental effects.
Recommended testing: EPA has determined that an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN substance
when not used in mineral oil.
CFR citation: 40 CFR 721.10035.
PMN Number P-02-406
Chemical name: Acetaldehyde based polymer (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a corrosion inhibitor. EPA has
identified health and environmental concerns for this substance. EPA
has identified health concerns for carcinogenicity and dermal
sensitization based on analogy to structurally similar chemicals. Based
on structural analogy to aldehydes, EPA is concerned that toxicity to
aquatic organisms may occur at concentrations as low as 1 ppb of the
PMN substance in surface waters. In addition, the PMN substance may be
persistent, bioaccumulative, and potentially toxic 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). 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
PMN substance may present an unreasonable risk. EPA has determined,
however, that other domestic manufacturing or other uses that result in
predictable or purposeful releases to surface water could result in
exposures which may cause serious chronic human health effects and
significant environmental effects since the 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 the tiered
testing as described in the New Chemicals Program's PBT Category would
help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10036.
PMN Number P-02-423
Chemical name: Complex halogenated salt of tris(ethylated
aminocarbocyclic)methane (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
colorant for inks. Based on structurally similar compounds, EPA has
identified human health concerns for carcinogenicity, mutagenicity,
reproductive effects, and developmental effects from inhalation
exposure to the PMN substance. In addition, based on structurally
similar compounds, EPA expects toxicity to aquatic organisms at surface
water concentrations above 1 ppb. As described in the PMN, significant
worker and environmental exposure are unlikely. 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 above 1 ppb or any processing or use beyond the site of
manufacture or import could result in worker and environmental
exposures which may cause carcinogenic and serious chronic effects in
humans and significant environmental effects. 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 a prenatal developmental
toxicity study by the oral route (OPPTS 870.3700 test guideline), a
reproductive and fertility effects study (OPPTS 870.3800 test
guideline), a Salmonella typhimurium reverse mutation assay (40 CFR
798.5265), and a mammalian erythrocyte micronucleus study by the
intraperitoneal route (OPPTS 870.5395 test guideline) would help
characterize the human health effects of the PMN substance. Positive
results in the mutagencity studies would trigger a carcinogenicity
study (OPPTS 870.4200 test guideline). In addition, EPA has determined
that a fish acute toxicity test (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity test (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity test (OPPTS 850.5400 test
guideline (public draft)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10037.
PMN Number P-02-434
Chemical name: Trimellitic anhydride, polymer with substituted glycol,
alkyl phenols and ethoxylated nonylphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as
curing resin for industrial can coatings. Based on structural analogy
to esters, EPA is concerned that toxicity to aquatic organisms may
occur at concentrations as low as 1 ppb of the PMN substance in surface
waters. As described in the PMN, the substance is not released to
surface waters. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that 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 an aerobic biodegradation
test with an analytical methodology to identify the branched-nonyl
phenol degradation product (OPPTS 835.3100 test guideline) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10038.
PMN Number P-02-514
[[Page 14691]]
Chemical name: Diethoxybenzenamine derivative, diazotized, coupled with
aminonaphthalenesulfonic acid derivative, ammonium 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 dyestuff in printing ink. Based on
structural analogy, EPA has identified concerns for carcinogenicity,
mutagenicity, and developmental toxicity for the substituted beta-
naphthylamine azo reduction product, blood and developmental toxicity
for the aniline-acid-based azo reduction product, and carcinogenicity,
developmental, liver toxicity and sensitization for the para-
phenylenediamine-based azo reduction product. There is concern for
chronic effects based on the submitted 28-day subchronic study with a
No Observed Adverse Effect Level (NOAEL) of 15 mg/kg. As described in
the PMN, worker 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 domestic manufacture or processing or use of the
substance as a solid may cause serious health 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)(3)(iii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two species (40 CFR 799.9370), an
Ames assay with the Prival modification with a concurrent positive
control (OPPTS 870.5100 test guideline), and a 90-day inhalation
toxicity study in rats (OPPTS 870.3465 test guideline) would help
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10039.
PMN Number P-02-522
Chemical name: Substituted acridine naphtha substituted benzamide
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be in exhaust dyeing of polyester fibers.
Based on analogy to neutral organics, EPA is concerned that toxicity to
aquatic organisms may occur at concentrations above 2 ppb of the PMN
substance in surface waters. As described in the PMN, releases of the
substance are not expected to result in surface water concentrations
above 2 ppb. Therefore, EPA has not determined that the proposed
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in release to surface waters in concentrations
above 2 ppb may cause significant adverse environmental effects. Based
on this information, the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal
toxicity test (OPPTS 850.5400 test guideline (public draft)), a fish
chronic 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.
CFR citation: 40 CFR 721.10040.
PMN Number P-02-530
Chemical name: 1-Butanone, 2-(dimethylamino)-2-[(4-
methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-.
CAS number: 119344-86-4.
Basis for action: The PMN states that the substance will be used as a
photo initiator for coatings and inks. Based on structural analogy to
aliphatic amines, EPA is concerned that toxicity to aquatic organisms
may occur at concentrations as low as 2 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters in significant quantities. 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 domestic manufacture of the PMN substance may result in
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 a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity test (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10041.
PMN Number P-02-585
Chemical name: 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-.
CAS number: 6712-98-7.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a grinding aid and intermediate. EPA
has identified health concerns for lung sensitization and
carcinogenicity based on analogy to triethanolamine. There is concern
for developmental toxicity, eye irritation, liver toxicity, kidney
toxicity, and blood toxicity based on submitted test data. As described
in the PMN, significant inhalation exposure is unlikely. 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 other than as described in
the PMN may result in significant human exposure. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in rats (OPPTS 870.3700 test
guideline) would help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.10042.
PMN Number P-02-697
Chemical name: Dineopentyl-4-substituted phthalate (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a catalyst component. EPA has
identified health and environmental concerns because the PMN substance
may be persistent, bioaccumulative, and toxic 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
has identified health concerns for developmental toxicity based on
analogy to other phthalates and concerns for liver, kidney, and
neurotoxicity based on analogy to haloaromatic compounds. 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 PMN
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the PMN substance which may result in
predictable or purposeful release of the PMN substance into waters of
the United States or any use of the PMN substance other than as
described in the PMN could result in exposures which may cause serious
chronic human health effects and significant
[[Page 14692]]
environmental effects since the PMN substance has been characterized by
EPA as a PBT. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemicals Program's PBT Category would
help characterize the PBT attributes of the PMN substance.
CFR citation: 40 CFR 721.10043.
PMN Number P-02-698
Chemical name: Metal oxide, modified with alkyl and vinyl terminated
polysiloxanes (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an
adhesive. EPA has identified health concerns for lung toxicity based on
analogy to poorly soluble respirable particulates. As described in the
PMN, significant worker exposure is unlikely. 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 manufacturing, processing, or use of the substance as a
powder could result in exposures which may cause serious health
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity study in rodents with a 60-day holding period (OPPTS 870.3465
test guideline) would help characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.10044.
PMN Number P-02-737
Chemical name: Diazotized substituted heteromonocycle coupled with
naphthalene sulfonic acid derivative, nickel complex, alkaline 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 colorant for coating compositions.
EPA has identified concerns for carcinogenicity, pulmonary
sensitization, immunotoxicity, developmental toxicity, and
neurotoxicity from analogous compounds, and carcinogenicity,
mutagenicity, and developmental toxicity for the azo reduction
products. As described in the PMN, 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 domestic
manufacture or processing or use of the substance as a solid may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(1)(i)(D),
(b)(3)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that a 90-day oral toxicity
test in rodents (OPPTS 870.3100 test guideline), a bacterial reverse
mutation test with Prival modification (OPPTS 870.5100 test guideline),
and an unscheduled DNA synthesis test in rat hepatocytes (OPPTS
870.5550 test guideline) would help characterize the human health
effects of the PMN substance. If warranted by the results of any of the
three above studies, a carcinogenicity test (OPPTS 870.4200 test
guideline) is recommended.
CFR citation: 40 CFR 721.10045.
PMN Number P-02-747
Chemical name: Polyaromatic amine phosphate (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
film additive. Based on structural analogy to soluble nonionic dyes and
inorganic phosphates, EPA is concerned that toxicity to aquatic
organisms may occur at concentrations as low as 10 ppb of the PMN
substance in surface waters. As described in the PMN, the substance is
not released to surface waters. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that 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 a fish acute toxicity test
(OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity test (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10046.
PMN Number P-02-766
Chemical name: Polyphosphoric acids, compds. with piperazine.
CAS number: 383905-85-9.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a flame retardant. Based on analogy to
aliphatic amines and inorganic phosphates, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations as low as 10
ppb of the PMN substance in surface waters. As described in the PMN,
the substance is not released to surface waters in significant
quantities. 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 an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10047.
PMN Number P-02-869
Chemical name: Substituted anthraquinone (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a
site limited intermediate. Based on structural analogy to phenols, EPA
is concerned that chronic toxicity to aquatic organisms may occur at
concentrations above 1 ppb of the PMN substance in surface waters. As
described in the PMN, releases of the substance are not expected to
result in surface water concentrations above 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 a manufacture/importation volume greater than 4,500
kilograms/year may result in 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 a fish early life stage
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 (OPPTS 850.5400 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10048.
[[Page 14693]]
PMN Number P-02-912
Chemical name: Phenol, 4,4'-cyclohexylidenebis[2-methyl-.
CAS number: 2362-14-3.
Basis for action: The PMN states that the substance will be used as a
raw material. Based on structural analogy to phenols, EPA is concerned
that chronic toxicity to aquatic organisms may occur at concentrations
as low as 1 ppb of the PMN substance 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, processing, or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any 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 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.
CFR citation: 40 CFR 721.10049.
PMN Number P-02-929
Chemical name: Disubstituted-N'- hydroxy-benzenecarboximidamide
(generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an
intermediate. EPA has concerns for chronic toxicity to blood, kidney,
and liver based on a submitted 28-day study. As described in the PMN,
significant worker exposure is unlikely. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA determined, however,
that use of the substance other than as an intermediate may result in
exposures which 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 a 90-day oral toxicity
study in rodents by the gavage route (OPPTS 870.3100 test guideline)
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10050.
PMN Number P-02-961
Chemical name: Spiro naphthoxazine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as a colorant. Based on structural analogy
to neutral organic chemicals, EPA expects chronic toxicity to aquatic
organisms at concentrations as low as 1 ppb of the PMN substance in
surface waters. As described in the PMN, the substance is not released
to surface waters in significant quantities. 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 domestic manufacture of the substance 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 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.
CFR citation: 40 CFR 721.10051.
PMN Number P-02-1088
Chemical name: Aminoalkyl substituted alkylphenol (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be in a destructive use. Based on structural
analogy to phenols and aliphatic amines, EPA is concerned that toxicity
to aquatic organisms may occur at concentrations as low as 1 ppb of the
PMN substance in surface waters. As described in the PMN, the substance
is not released to surface waters. Therefore, EPA has not determined
that the proposed manufacturing 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 an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity test (OPPTS 850.1075 test guideline (public draft))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10052.
PMN Number P-03-41
Chemical name: Alkyl silane methacrylate (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
structural analogy to methacrylates and esters, EPA is concerned that
toxicity to aquatic organisms may occur at concentrations as low as 3
ppb of the PMN substance in surface waters. As described in the PMN,
the substance is not released to surface waters. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that 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 (OPPTS 850.1075 test guideline (public draft)), a
daphnid acute toxicity test (OPPTS 850.1010 test guideline (public
draft)), and an algal toxicity test (OPPTS 850.5400 test guideline
(public draft)) would help characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10053.
PMN Number P-03-43
Chemical name: Phenol, polymer with formaldehyde, 3-[(2-
aminocyclohexyl)amino]-2-hydroxypropyl ethers.
CAS number: 452082-53-0.
Basis for action:The PMN states that the generic (non-confidential) use
of the substance will be as a resin component. Based on structural
analogy to polycationic polymers, EPA is concerned that toxicity to
aquatic organisms may occur at concentrations as low as 20 ppb of the
PMN substance in surface waters. As described in the PMN, the substance
is not released to surface waters. Therefore, EPA has not determined
that the proposed manufacturing, processing, or use of the substance
may present an unreasonable risk. EPA has determined, however, that
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 an algal toxicity test
(OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity test (OPPTS 850.1010 test guideline (public draft)), a fish
acute toxicity test (OPPTS 850.1075 test guideline (public draft)), and
a fish acute toxicity test mitigated
[[Page 14694]]
by humic acid (OPPTS 850.1085 test guideline (public draft)) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10054.
PMN Number P-03-46
Chemical name: 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-
, N-soya acyl derivs., inner salts.
CAS number: 136504-87-5.
Basis for action: The PMN states that the generic (non-confidential)
use of the substance will be as an oilfield foamer. EPA has identified
health concerns for developmental toxicity, neurotoxicity, irritation
and corrosion to skin and eyes, and lung effects based on analogy to
similar quaternary compounds. As described in the PMN, significant
inhalation exposure is unlikely. 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 other than as described in the PMN may result in
significant human exposure. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in rats or rabbits (OPPTS 870.3700
test guideline) and a repeated dose 28-day oral toxicity study in rats
(OPPTS 870.3050 test guideline) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10055.
PMN Number P-03-47
Chemical name: Benzenemethanaminium, N-(3-aminopropyl)-N,N-dimethyl-,
N-soya acyl derivs., chlorides.
CAS number: 90194-13-1.
Basis for action: The PMN states that the generic (non-confidential)
use of substance will be as an oilfield corrosion inhibitor. EPA has
identified health concerns for developmental toxicity, neurotoxicity,
lung effects, irritation to the lungs and mucous membranes, and severe
eye irritation based on analogy to similar quaternary compounds. As
described in the PMN, significant inhalation exposure is unlikely.
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 other
than as described in the PMN may result in significant human exposure.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in rats or rabbits (OPPTS 870.3700
test guideline) and a repeated dose 28-day oral toxicity study in rats
(OPPTS 870.3050 test guideline) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.10056.
IV. Objectives and Rationale for this Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 13 of the 65
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.
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 the 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. Manufacturers,
importers, and processors are responsible for ensuring that a new
chemical substance subject to a final SNUR is listed on the TSCA
Inventory.
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). In accordance with 40 CFR
721.160(c)(3)(ii) and 721.170(d)(4)(i), this rule will be effective May
29, 2007, unless EPA receives a written notice by April 30, 2007 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 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 recommended tests are provided for
informational purposes. EPA strongly encourages persons, before
performing any testing, to consult with the Agency pertaining to
[[Page 14695]]
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 the SNURs that
include specific significant new uses that are CBI.
A manufacturer or importer 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 or importer must show
that it has a bona fide intent to manufacture or import the chemical
substance and must identify the specific use for which it intends to
manufacture or import the chemical substance. If EPA concludes that the
person has shown a bona fide intent to manufacture or import 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 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 or importer 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 or import 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 or import 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 13 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 a notice of commencement
(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, 35 of the 65 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 section 5(a)(1)(B) of TSCA
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
[[Page 14696]]
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 submitters 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. Notification on Substances for Which Significant New Use Rules are
Not Being Issued
As required in 40 CFR 721.160(a)(2), EPA is providing notification
on the following two chemical substances that are subject to final TSCA
section 5(e) consent orders but for which EPA has decided not to issue
significant new use rules at this time. EPA is not publishing SNURs for
PMNs P-02-193 and P-03-394 because they are subject to exposure-based
consent orders. EPA's exposure-based policies for new chemical
substances are based on TSCA section 5(e)(1)(A)(ii)(II) and are
described on the New Chemicals website at http://www.epa.gov/oppt/newchems/pubs/expbased.htm. Exposure-based consent orders are based on
two findings: 1) Insufficient information available on the health and
environmental effects of the PMN substance, and 2) expected substantial
production volume and significant or substantial human exposure and/or
release to the environment. Exposure-based consent orders prohibit the
submitter from exceeding a specific, aggregate production or import
volume unless the submitter has conducted the fate, aquatic toxicity,
and/or health effects testing specified in the order and submitted the
results to EPA. The production or import volume limit is usually set so
that it will occur within a few years. Therefore, instead of publishing
and often revoking exposure-based SNURs within a short timespan, EPA
generally defers publication of SNURs on substances subject to
exposure-based consent orders until the test data are received. In many
cases, data received through an exposure-based consent order confirm
the Agency's prediction of low or no risk, so no further regulatory
action is warranted.
XI. 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.
XII. Statutory and Executive Order Reviews
1. Executive Order 12866: Regulatory Planning and Review
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 a proposed or final SNUR is not a
``significant regulatory action'' subject to review by OMB, because it
does not meet the criteria in section 3(f) of the Executive order.
2. 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.
3. 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 this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR 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.'' By definition of the word
``new,'' and based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activity. Since a SNUR only requires that any person who intends to
engage in such activity in the future must first notify EPA by
submitting a SNUN, no economic impact will even occur until someone
decides to engage in those activities. Although some small entities may
decide to conduct such activities 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 10 notices per year. Of those SNUNs
submitted, none appear to be from small entities in response to any
SNUR. In addition, the estimated reporting cost for submission of a
SNUN (see Unit IX.), is minimal regardless of the size of the firm.
Therefore, EPA believes that the potential economic impact of complying
with this SNUR is
[[Page 14697]]
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 it's 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.
4. 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 reason 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).
5. Executive Order 13132: Federalism
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).
6. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
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 6, 2000), do not apply to this rule.
7. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
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.
8. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use
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.
9. National Technology Transfer 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.
10. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
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).
11. Executive Order 12630: Governmental Actions and Interference with
Constitutionally Protected Property Rights (Takings)
EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 15, 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.
12. Executive Order 12988: Civil Justice Reform
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).
13. 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 the final rule 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 this 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: March 22, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
0
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. 721.10002 to subpart E to read as follows:
Sec. 721.10002 2-Thiazolidinone.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-thiazolidinone
(PMN P-97-415; CAS No. 2682-49-7) 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)(3), (a)(4), (a)(6)(i), (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 (either half- or full-face) equipped with N100 (if
aerosols absent), R100, or P100 filters; 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
[[Page 14698]]
continuous flow mode and equipped with a hood or helmet or tight-
fitting facepiece (either half- or full-face). As an alternative to the
respiratory requirements listed here, a manufacturer, importer, or
processor may choose to follow the new chemical exposure limit (NCEL)
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.7 mg/m\3\ as an 8-hour time-weighted average.
Persons 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 are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0
percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(ix),
(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv) (use respiratory
protection or maintain workplace airborne concentrations at or below an
8-hour time-weighted average of 0.7 mg/m\3\), (g)(2)(v), (g)(3)(ii),
(g)(4)(i), (g)(4)(ii), (g)(4)(iii), and (g)(5). The following statement
shall appear on each label as specified in Sec. 721.72(b) and the
Material Safety Data Sheet (MSDS) as specified in Sec. 721.72(c). The
substance may cause severe eye irritation. The substance may cause
internal organ effects (blood, liver, and kidney). The substance may
cause developmental/maternal effects. When handling this substance as a
powder, use respiratory protection.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (p) (300,000 kilograms), (v)(1),
(w)(1), and (x)(1).
(iv) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(a)(2), (a)(3), (b)(1), (b)(2), (b)(3), (c)(1), (c)(2), and (c)(3).
(v) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(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), (i), (j), 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
3. By adding new Sec. 721.10003 to subpart E to read as follows:
Sec. 721.10003 Manganese heterocyclic tetraamine complex (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
manganese heterocyclic tetraamine complex (PMNs P-98-625/626/627/628/
629 and P-00-614/617) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (10,000 kilograms per chemical
substance).
(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.
0
4. By adding new Sec. 721.10004 to subpart E to read as follows:
Sec. 721.10004 2-Butenoic acid, 4,4'-
[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C8-10-isoalkyl esters, C9-rich.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-butenoic acid,
4,4'-[(dibutylstannylene)bis(oxy)]bis[4-oxo-, (2Z,2'Z)-, di-
C8-10-isoalkyl esters, C9-rich (PMN P-98-1181;
CAS No. 247041-56-1) 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), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(2), (w)(2), (x)(2), and (y)(1).
(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.
0
5. By adding new Sec. 721.10005 to subpart E to read as follows:
Sec. 721.10005 2-Butenoic acid, 4,4'-[(dibutylstannylene)bis(oxy)]bis
[4-oxo-, (2Z,2'Z)-, di-C9-11-isoalkyl esters,
C10-rich.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-butenoic acid, 4
,4'-[(dibutylstannylene)bis(oxy)]bis [4-oxo-, (2Z,2'Z)-, di-
C9-11-isoalkyl esters, C10-rich (PMN P-98-1182)
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), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(2), (w)(2), (x)(2), and (y)(1).
(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.
0
6. By adding new Sec. 721.10006 to subpart E to read as follows:
Sec. 721.10006 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
metal oxide (PMN P-99-511) 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(s) (60,000 kilograms).
(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.
0
7. By adding new Sec. 721.10007 to subpart E to read as follows:
[[Page 14699]]
Sec. 721.10007 Alcohols, C12-14- secondary, ethoxylated
propoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alcohols,
C12-14- secondary, ethoxylated propoxylated (PMN P-00-11;
CAS No. 103331-86-8) 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)(4), (b)(4), and (c)(4) (N = 50).
(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
8. By adding new Sec. 721.10008 to subpart E to read as follows:
Sec. 721.10008 Manganese strontium oxide (MnSrO3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganese strontium
oxide (MnSrO3) (PMN P-00-1121; CAS No. 12163-45-0) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
9. By adding new Sec. 721.10009 to subpart E to read as follows:
Sec. 721.10009 Manganese yttrium oxide (MnYO3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganese yttrium
oxide (MnYO3) (PMN P-00-1122; CAS No. 12032-75-6) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
10. By adding new Sec. 721.10010 to subpart E to read as follows:
Sec. 721.10010 Barium manganese oxide (BaMnO3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as barium manganese
oxide (BaMnO3) (PMN P-00-1123; CAS No. 12230-80-7) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
11. By adding new Sec. 721.10011 to subpart E to read as follows:
Sec. 721.10011 Barium calcium manganese strontium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as barium calcium
manganese strontium oxide (PMN P-00-1124; CAS No. 359427-90-0) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 14700]]
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.
0
12. By adding new Sec. 721.10012 to subpart E to read as follows:
Sec. 721.10012 Manganate (MnO2\1\-), calcium
(2:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganate
(MnO2\1\-), calcium (2:1) (PMN P-00-1125; CAS No.
12049-47-7) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
13. By adding new Sec. 721.10013 to subpart E to read as follows:
Sec. 721.10013 Manganese yttrium oxide
(Mn2YO5).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as manganese yttrium
oxide (Mn2YO5) (PMN P-00-1126; CAS No. 12438-71-
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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iii), (g)(1)(vii),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3)(ii), (g)(4)(i), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) (manufacture, processing, or use of
the PMN substance if the particle size is less than 10 microns) and
(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (f), (g), (h), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
14. By adding new Sec. 721.10014 to subpart E to read as follows:
Sec. 721.10014 Halogenated naphthalic anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated naphthalic anhydride (PMN P-01-109) 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.
0
15. By adding new Sec. 721.10015 to subpart E to read as follows:
Sec. 721.10015 Halogenated benzimidazole (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzimidazole (PMN P-01-110) 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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16. By adding new Sec. 721.10016 to subpart E to read as follows:
Sec. 721.10016 Dibenzimidazothianaphthalene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dibenzimidazothianaphthalene (PMN P-01-111) 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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17. By adding new Sec. 721.10017 to subpart E to read as follows:
Sec. 721.10017 Amine terminated bisphenol A diglycidyl ether polymer
(generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as amine
terminated bisphenol A diglycidyl ether polymer (PMNs P-01-257/258/259
and P-01-261) 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:
[[Page 14701]]
(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.
0
18. By adding new Sec. 721.10018 to subpart E to read as follows:
Sec. 721.10018 Calcium hydroxide oxide silicate
(Ca6(OH)2O2(Si2O5
)3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as calcium hydroxide
oxide silicate
(Ca6(OH)2O2(Si2O5
)3) (PMN P-01-442; CAS No. 13169-90-9) 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 (f), (j) (use other than as filler to
reinforce resins, additive for resins, and filter medium), (v)(1), and
(x)(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 (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.
0
19. By adding new Sec. 721.10019 to subpart E to read as follows:
Sec. 721.10019 Benzoic acid, 2-chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 2-
chloro-5-nitro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester (PMN
P-01-563; CAS No. 174489-76-0) 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) Release to water. Requirements as specified 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.
0
20. By adding new Sec. 721.10020 to subpart E to read as follows:
Sec. 721.10020 Benzoic acid, 5-amino-2-chloro-, 1,1-dimethyl-2-oxo-2-
(2-propenyloxy) ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzoic acid, 5-
amino-2-chloro-, 1,1-dimethyl-2-oxo-2-(2-propenyloxy) ethyl ester (PMN
P-01-564; CAS No. 174489-43-1) 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 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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21. By adding new Sec. 721.10021 to subpart E to read as follows:
Sec. 721.10021 Magnesium potassium titanium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as magnesium potassium
titanium oxide (PMN P-01-764; CAS No. 39290-90-9) 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)(6)(i), (b) (concentration set at 0.1 percent), 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 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).
As an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the new
chemical exposure limit (NCEL) provisions listed in the TSCA section
5(e) consent order for this substance. The NCEL is 5 mg/m\3\ as an 8-
hour time-weighted average. Persons 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 are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent),
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 5 mg/m\3\) and (g)(5).
(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), (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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22. By adding new Sec. 721.10022 to subpart E to read as follows:
[[Page 14702]]
Sec. 721.10022 Benzenamine, N-phenyl-, ar'-(C9-rich
C8-10-branched alkyl) derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenamine, N-
phenyl-, ar'-(C9-rich C8-10-branched alkyl)
derivs (PMN P-01-769; CAS No. 333955-69-4) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (antioxidant for lubricating oils).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(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), (i), 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.
0
23. By adding new Sec. 721.10023 to subpart E to read as follows:
Sec. 721.10023 Benzenamine, N-phenyl-, ar ar'-(C9-rich
C8-10-branched alkyl) derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenamine, N-
phenyl-, ar,ar'-(C9-rich C8-10-branched alkyl)
derivs (PMN P-01-770; CAS No. 333955-70-7) 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) (antioxidant for lubricating oils).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(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), (i), 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.
0
24. By adding new Sec. 721.10024 to subpart E to read as follows:
Sec. 721.10024 10H-Phenothiazine, ar-(C9-rich
C8-10-branched alkyl) derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 10H-phenothiazine,
ar-(C9-rich C8-10-branched alkyl) derivs (PMN P-
01-771; CAS No. 333955-79-6) 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) (antioxidant for lubricating oils).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(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), (i), 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.
0
25. By adding new Sec. 721.10025 to subpart E to read as follows:
Sec. 721.10025 10H-Phenothiazine, ar, ar'-(C9-rich
C8-10-branched alkyl) derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as 10H-phenothiazine,
ar, ar'-(C9-rich C8-10-branched alkyl) derivs
(PMN P-01-772; CAS No. 333955-80-9) 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) (antioxidant for lubricating oils).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(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), (i), 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.
0
26. By adding new Sec. 721.10026 to subpart E to read as follows:
Sec. 721.10026 Cashew, nutshell liq., ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cashew, nutshell
liq., ethoxylated (PMN P-01-856; CAS No. 350820-95-0) 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) (any manufacturing, processing, or use
of the PMN substance with less than 55 moles of the ethoxy or with an
average molecular weight less than 2,700 daltons).
(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.
0
27. By adding new Sec. 721.10027 to subpart E to read as follows:
Sec. 721.10027 Ethoxylated alkylsulfate, substituted alkylamine salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethoxylated alkylsulfate, substituted alkylamine salt (PMN P-01-862) 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.
[[Page 14703]]
0
28. By adding new Sec. 721.10028 to subpart E to read as follows:
Sec. 721.10028 Disubstituted benzene metal salts (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
disubstituted benzene metal salts (PMNs P-01-901 and P-01-902) 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) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1) and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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.
0
29. By adding new Sec. 721.10029 to subpart E to read as follows:
Sec. 721.10029 Isocyanate compound, modified with methoxysilane
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanate compound, modified with methoxysilane (PMN P-01-918) 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)(ii), (a)(2)(iii), (a)(2)(iv), (a)(3),
(a)(4), and (a)(6). The following National Institute for Occupational
Safety and Health (NIOSH)-approved respirators meet the minimum
requirement for Sec. 721.63(a)(4): Air-purifying, tight-fitting full-
face respirator equipped with N100 (if oil aerosols absent), R100, or
P100 filters; powered air-purifying respirator equipped with a tight-
fitting full facepiece and High Efficiency Particulate Air (HEPA)
filters; supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a tight-fitting full facepiece.
As an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the new
chemical exposure limit (NCEL) provisions listed in the TSCA section
5(e) consent order for this substance. The NCEL is 0.05 mg/m\3\ as an
8-hour time-weighted average. Persons 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 are approved by EPA will receive NCELs provisions
comparable to those contained in the corresponding section 5(e) consent
order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 1.0 percent),
(f), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv) (use
respiratory protection or maintain workplace airborne concentrations at
or below an 8-hour time-weighted average of 0.05 mg/m\3\), (g)(2)(v),
and (g)(5). The following statements shall appear on each label as
specified in Sec. 721.72(b) and the Material Safety Data Sheet (MSDS)
as specified in Sec. 721.72(c): This substance may cause skin
irritation and sensitization.
(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.
0
30. By adding new Sec. 721.10030 to subpart E to read as follows:
Sec. 721.10030 Pyrimido[5,4-g]pteridine-2,4,6,8-tetramine, 4-
methylbenzenesulfonate, base-hydrolyzed.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pyrimido[5,4-
g]pteridine-2,4,6,8-tetramine, 4-methylbenzenesulfonate, base-
hydrolyzed (PMN P-01-919; CAS No. 346709-25-9) 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(f).
(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.
0
31. By adding new Sec. 721.10031 to subpart E to read as follows:
Sec. 721.10031 Lithium potassium titanium oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as lithium potassium
titanium oxide (PMN P-02-214; CAS No. 39318-30-4) 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)(4), (a)(6)(i), (b) (concentration set at 0.1 percent), and
(c). The following National Institute for Occupational Safety and
Health (NIOSH)-approved respirators with an APF of 10-25 meet the
minimum requirements for Sec. 721.63(a)(4): Air-purifying, tight-
fitting respirator (either half- or full-face) equipped with N100 (if
aerosols absent), R100, or P100 filters; powered air-purifying,
respirator equipped with a loose-fitting hood or helmet or tight-
fitting facepiece (either half- or full-face) and High Efficiency
Particulate Air (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). As an
alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the new
chemical exposure limit (NCEL) provisions listed in the TSCA section
5(e) consent order for this substance. The NCEL is 5 mg/m\3\ as an 8-
hour time-weighted average. Persons 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 are approved by EPA will receive NCELs provisions
comparable to
[[Page 14704]]
those contained in the corresponding section 5(e) consent order.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent),
(f), (g)(1)(ii), (g)(2)(ii), (g)(2)(iv) (use respiratory protection or
maintain workplace airborne concentrations at or below an 8-hour time-
weighted average of 5 mg/m\3\), and (g)(5).
(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), (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.
0
32. By adding new Sec. 721.10032 to subpart E to read as follows:
Sec. 721.10032 Acrylic acid, polymer with substituted acrylamides
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as acrylic
acid, polymer with substituted acrylamides (PMN P-02-269) 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) (any manufacturing, processing, or use
of the PMN substance with an aerodynamic diameter less than 10
microns).
(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.
0
33. By adding new Sec. 721.10033 to subpart E to read as follows:
Sec. 721.10033 Zinc, [ethanedioato(2-)-. kappa. O\1\, . kappa.
O\2\]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as zinc,
[ethanedioato(2-)-. kappa. O\1\, . kappa. O\2\]- (PMN P-02-322; CAS No.
547-68-2) 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 Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=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.
0
34. By adding new Sec. 721.10034 to subpart E to read as follows:
Sec. 721.10034 Substituted pyridine coupled with diazotized
substituted nitrobenzonitrile, diazotized substituted benzenamine and
substituted pyridinecarbonitrile (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted pyridine coupled with diazotized substituted
nitrobenzonitrile, diazotized substituted benzenamine and substituted
pyridinecarbonitrile (PMN P-02-359) 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 Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=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.
0
35. By adding new Sec. 721.10035 to subpart E to read as follows:
Sec. 721.10035 Alkylbenzene sulfonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylbenzene sulfonate (PMN-02-382) 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) (manufacture, import, or processing of
the chemical without 19 percent or more mineral oil as a diluent).
(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.
0
36. By adding new Sec. 721.10036 to subpart E to read as follows:
Sec. 721.10036 Acetaldehyde based polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acetaldehyde based polymer (PMN P-02-406) 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(f).
(ii) Release to water. Requirements as specified Sec. 721.90
(b)(1) and (c)(1).
(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), (i), 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
37. By adding new Sec. 721.10037 to subpart E to read as follows:
[[Page 14705]]
Sec. 721.10037 Complex halogenated salt of
tris(ethylatedaminocarbocyclic)methane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as complex
halogenated salt of tris(ethylatedaminocarbocyclic)methane (PMN P-02-
423) 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 (d) and (e).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(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), (i), 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
38. By adding new Sec. 721.10038 to subpart E to read as follows:
Sec. 721.10038 Trimellitic anhydride, polymer with substituted
glycol, alkyl phenols and ethoxylated nonylphenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
trimellitic anhydride, polymer with substituted glycol, alkyl phenols
and ethoxylated nonylphenol (PMN P-02-434) 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 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.
0
39. By adding new Sec. 721.10039 to subpart E to read as follows:
Sec. 721.10039 Diethoxybenzenamine derivative, diazotized, coupled
with aminonaphthalenesulfonic acid derivative, ammonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
diethoxybenzenamine derivative, diazotized, coupled with
aminonaphthalenesulfonic acid derivative, ammonium salt (PMN P-02-514)
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 (f), (v)(2), and (x)(2).
(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.
0
40. By adding new Sec. 721.10040 to subpart E to read as follows:
Sec. 721.10040 Substituted acridine naphtha substituted benzamide
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted acridine naphtha substituted benzamide (PMN P-02-522) 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 Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply tothis 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
41. By adding new Sec. 721.10041 to subpart E to read as follows:
Sec. 721.10041 1-Butanone, 2-(dimethylamino)-2-[(4-
methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanone, 2-
(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(4-morpholinyl)phenyl]-
(PMN P-02-530; CAS No. 119344-86-4) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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.
0
42. By adding new Sec. 721.10042 to subpart E to read as follows:
Sec. 721.10042 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol, 1-
[bis(2-hydroxyethyl)amino]- (PMN P-02-585; CAS No. 6712-98-7) 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.
0
43. By adding new Sec. 721.10043 to subpart E to read as follows:
[[Page 14706]]
Sec. 721.10043 Dineopentyl-4-substituted phthalate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dineopentyl-4-substituted phthalate (PMN P-02-697) 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) Release to water. Requirements as specified Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply tothis section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (i), 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.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
44. By adding new Sec. 721.10044 to subpart E to read as follows:
Sec. 721.10044 Metal oxide, modified with alkyl and vinyl terminated
polysiloxanes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal
oxide, modified with alkyl and vinyl terminated polysiloxanes (PMN P-
02-698) 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 (v)(1), (w)(1), and (x)(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 (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.
0
45. By adding new Sec. 721.10045 to subpart E to read as follows:
Sec. 721.10045 Diazotized substituted heteromonocycle coupled with
naphthalene sulfonic acid derivative, nickel complex, alkaline salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
diazotized substituted heteromonocycle coupled with naphthalene
sulfonic acid derivative, nickel complex, alkaline salt (PMN P-02-737)
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 (f), (v)(2), and (x)(2).
(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.
0
46. By adding new Sec. 721.10046 to subpart E to read as follows:
Sec. 721.10046 Polyaromatic amine phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyaromatic amine phosphate (PMN P-02-747) 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 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.
0
47. By adding new Sec. 721.10047 to subpart E to read as follows:
Sec. 721.10047 Polyphosphoric acids, compds. with piperazine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a polyphosphoric
acids, compds. with piperazine (PMN P-02-766; CAS No. 383905-85-9) 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.
0
48. By adding new Sec. 721.10048 to subpart E to read as follows:
Sec. 721.10048 Substituted anthraquinone (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted anthraquinone (PMN P-02-869) 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(s) (4,500 kilograms).
(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.
0
49. By adding new Sec. 721.10049 to subpart E to read as follows:
[[Page 14707]]
Sec. 721.10049 Phenol, 4,4'- cyclohexylidene bis[2-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a phenol, 4,4'-
cyclohexylidene bis[2-methyl- (PMN P-02-912; CAS No. 2362-14-3) 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) Release to water. Requirements as specified 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.
0
50. By adding new Sec. 721.10050 to subpart E to read as follows:
Sec. 721.10050 Disubstituted-N'- hydroxy-benzenecarboximidamide
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
disubstituted-N'- hydroxy-benzenecarboximidamide (PMN P-02-929) 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(g).
(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.
0
51. By adding new Sec. 721.10051 to subpart E to read as follows:
Sec. 721.10051 Spiro naphthoxazine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as spiro
naphthoxazine (PMN P-02-961) 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(f).
(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.
0
52. By adding new Sec. 721.10052 to subpart E to read as follows:
Sec. 721.10052 Aminoalkyl substituted alkylphenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aminoalkyl substituted alkylphenol (PMN P-02-1088) 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.
0
53. By adding new Sec. 721.10053 to subpart E to read as follows:
Sec. 721.10053 Alkyl silane methacrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
silane methacrylate (PMN P-03-41) 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 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.
0
54. By adding new Sec. 721.10054 to subpart E to read as follows:
Sec. 721.10054 Phenol, polymer with formaldehyde, 3-[(2-
aminocyclohexyl)amino]-2-hydroxypropyl ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2-
hydroxypropyl ethers (PMN P-03-43; CAS No. 452082-53-0) 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) Release to water. Requirements as specified 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.
0
55. By adding new Sec. 721.10055 to subpart E to read as follows:
Sec. 721.10055 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-
dimethyl-, N-soya acyl derivs., inner salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium, 3-
amino-N-(carboxymethyl)-N,N-dimethyl-, N-soya acyl derivs., inner salts
(PMN P-03-46; CAS No. 136504-87-5) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
[[Page 14708]]
(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.
0
56. By adding new Sec. 721.10056 to subpart E to read as follows:
Sec. 721.10056 Benzenemethanaminium, N-(3-aminopropyl)-N,N-dimethyl-,
N-soya acyl derivs., chlorides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
benzenemethanaminium, N-(3-aminopropyl)-N,N-dimethyl-, N-soya acyl
derivs., chlorides (PMN P-03-47; CAS No. 90194-13-1) 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.
[FR Doc. E7-5797 Filed 3-28-07; 8:45 am]
BILLING CODE 6560-50-S