[Federal Register: March 28, 2003 (Volume 68, Number 60)]
[Rules and Regulations]
[Page 15061-15089]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr03-9]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPT-2002-0060; FRL-6758-7]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
[[Page 15062]]
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 62
chemical substances which were the subject of premanufacture notices
(PMNs) and subject to TSCA section 5(e) consent orders issued by EPA.
Today's action requires persons who intend to manufacture, import, or
process these substances for a significant new use to notify EPA at
least 90 days before commencing the manufacturing or processing of the
substance for a use designated by this rule as a significant new use.
The required notice will provide EPA with the opportunity to evaluate
the intended use, and if necessary, to prohibit or limit that activity
before it occurs to prevent any unreasonable risk of injury to human
health or the environment. EPA is promulgating this SNUR using direct
final procedures.
DATES: The effective date of this rule is May 27, 2003 without further
notice, unless EPA receives adverse comment or notice of intent to
submit adverse comment before April 28, 2003. This rule shall be
promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on April
11, 2003.
If EPA receives adverse comment or notice before April 28, 2003
that someone wishes to submit adverse or critical comments on EPA's
action in establishing a SNUR for one or more of the chemical
substances subject to this rule, EPA will withdraw the SNUR before the
effective date for the substance for which the comment or notice of
intent to comment is received and will issue a proposed SNUR providing
a 30-day period for public comment.
ADDRESSES: Comments or notice of intent to submit adverse or critical
comments may be submitted electronically, by mail, or through hand
delivery/courier. Follow the detailed instructions as provided in Unit
I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Acting Director, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov. For technical information contact: James Alwood, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail
address: alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
Potentially affected entities may include, but are not limited to:
[sbull] Chemical manufacturers (NAICS 325), e.g., Manufacturers,
importers, processors, and users of chemicals.
[sbull] Petroleum and coal product industries (NAICS 324), e.g.,
Manufacturers, importers, processors, and users of chemicals.
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 title 40 of the Code
of Federal Regulations (CFR) at 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.
B. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPPT-2002-0060 . The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The EPA Docket Center Reading
Room telephone number is (202) 566-1744 and the telephone number for
the OPPT Docket, which is located in EPA Docket Center, is (202) 566-
0280.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. The OPPTS harmonized test
guidelines referenced in this document are available at http://www.epa.gov/opptsfrs/home/guidelin.htm.
A frequently updated electronic
version of 40 CFR part 721 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr
721--00.html, a beta site
currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
[[Page 15063]]
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPPT-2002-0060. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to oppt.ncic@epa.gov,
Attention: Docket ID Number OPPT-2002-0060. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Building Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2002-0060. 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.
D. How Should I Submit CBI To the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
We invite you to provide your views on the various options we
propose, new approaches we haven't considered, the potential impacts of
the various options (including possible unintended consequences), and
any data or information that you would like the Agency to consider
during the development of the final action. You may find the following
suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the rule.
7. Make sure to submit your comments by the deadline in this
document.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.
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II. Background
A. What Action is the Agency Taking?
This SNUR will require persons to notify EPA at least 90 days
before commencing manufacturing, importing, or processing a substance
for any activity designated by this SNUR as a significant new use. The
supporting 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 the rules 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 section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a significant
new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice
to EPA at least 90 days before they manufacture, import, or process the
substance for that use. The mechanism for reporting under this
requirement is established under 40 CFR 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear under subpart A of 40 CFR part
721. 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. Persons subject to this SNUR must comply with the same notice
requirements and EPA regulatory procedures as submitters of PMNs under
section 5(a)(1)(A) of TSCA. 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 SNUR notice, 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 SNUR notice. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
Persons who intend to export a 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. Persons who intend to import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Such persons must certify that they are in
compliance with SNUR requirements. The EPA policy in support of the
import certification appears at 40 CFR part 707.
III. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for the following chemical substances under 40 CFR part
721, subpart E. In this unit, EPA provides a brief description for each
substance, including its 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 action taken by EPA in
the TSCA section 5(e) consent order or as a non-section 5(e) SNUR for
the substance (including the statutory citation and specific finding),
toxicity concern, and the CFR citation assigned in the regulatory text
section of this rule. The specific uses which are designated as
significant new uses are cited in the regulatory text section of this
document by reference to 40 CFR part 721, subpart E where the
significant new uses are described in detail. 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.
Where the underlying TSCA section 5(e) consent order prohibits the
PMN submitter from exceeding a specified production limit without
performing specific tests to determine the health or environmental
effects of a substance, the tests are described in this unit. As
explained further in Unit VI., the SNUR for such substances contains
the same production limit, and exceeding the production limit is
defined as a significant new use. Persons who intend to exceed the
production limit must notify the Agency by submitting a significant new
use notice (SNUN) at least 90 days in advance. In addition, this unit
describes tests that are recommended by EPA to provide sufficient
information to evaluate the substance, but for which no production
limit has been established in the TSCA section 5(e) consent order.
Descriptions of recommended tests are provided for informational
purposes.
Data on potential exposures or releases of the substances, testing
other than that specified in the TSCA section 5(e) consent order for
the substances, or studies on analogous substances, which may
demonstrate that the significant new uses being reported do not present
an unreasonable risk, may be included with significant new use
notification. Persons submitting a SNUN must comply with the same
notice requirements and EPA regulatory procedures as submitters of
PMNs, as stated in 40 CFR 721.1(c), including submission of test data
on health and environmental effects as described in 40 CFR 720.50.
EPA is not publishing SNURs for PMNs for P-99-309, P-99-492/493/
494/495/496/497, P-99-847, P-99-1106, P-99-1166, and P-99 -1389, which
are subject to a final TSCA section 5(e) consent order. The TSCA
section 5(e) consent orders for these substances are derived from an
exposure finding based solely on substantial production volume and
significant or substantial human exposure and/or release to the
environment of substantial quantities. For these cases there were
limited or no toxicity data available for the PMN substances. In such
cases, EPA regulates the new chemical substances under TSCA section
5(e) by requiring certain toxicity tests. For instance, chemical
substances with potentially substantial releases to surface waters
would be subject to toxicity testing of aquatic organisms and chemicals
with potentially substantial human exposures would be subject to health
effects testing for mutagenicity, acute effects, and subchronic
effects. However, for these substances, the short-term toxicity testing
required by the TSCA section 5(e) consent order is usually completed
within 1 to 2 years of notice of commencement (NOC). EPA's experience
with exposure-based SNURs requiring short-term testing is that the SNUR
is often revoked within 1 to 2 years when the test results are
received. Rather than issue and revoke SNURs in such a short span of
time, EPA will defer publication of exposure-based SNURs until either a
NOC or data demonstrating risk are received unless the toxicity testing
required is long-term. EPA is issuing this explanation and notification
as required in 40 CFR 721.160(a)(2) as it has determined that SNURs are
not needed at this time for these substances which are subject to a
final section 5(e) consent order under TSCA.
PMN Numbers P-98-0082/0083/0084
[[Page 15065]]
Chemical names: (generic) (P-98-0082 and P-98-0083) Alkoxylated
alkylpolyol acrylates, adduct with alkylamine and (generic) (P-98-0084)
Alkoxylated alkylpolyol acrylates.
CAS numbers: Not available.
Basis for action: The PMN substances will be used as binders for UV or
electron beam curable coatings for wood, paper, and plastics. Based on
structural analogy to aliphatic amines, EPA is concerned that toxicity
to aquatic organisms may occur at a concentration as low as 1 part per
billion (ppb) of the PMN substances in surface waters. Since
significant environmental exposure is not expected, as the substances
are not released to surface waters, as described in the PMNs, EPA has
not determined that the proposed manufacturing, processing, and use of
the substances may present an unreasonable risk. EPA has determined,
however, that other uses of the substances resulting in release to
surface waters may cause significant adverse environmental effects.
Based on this information the PMN substances meet the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substances. All tests should be conducted with the static methods and
nominal concentrations.
CFR citation: 40 CFR 721.465.
PMN Numbers P-98-0497 and P-98-0509
Chemical name: Propanoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-
trimethylbicyclo[2.2.1]hept-2-yl ester, rel-.
CAS number: 85586-67-0.
Basis for action: The PMN substances will be used as a fragrance
compound for air fresheners, soaps, shampoo, household detergents, and
bleach. Toxicity data on structurally similar esters indicate that the
PMN substances may cause toxicity to aquatic organisms. Based on these
data, EPA is concerned that toxicity to aquatic organisms may occur at
a concentration of 10 ppb of the PMN substances in surface waters.
Since significant environmental exposure is not expected as the PMN
substances are not released to surface waters in significant
quantities, EPA has not determined that the proposed processing and use
of the substances may present an unreasonable risk. EPA has determined,
however, that an increase in production volume may result in releases
of the PMN substances to surface waters which 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: The Agency has determined that an algal toxicity
study (OPPTS 850.5400 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and a
fish acute toxicity study (OPPTS 850.1075 test guideline (public
draft)) would help to characterize possible environmental effects of
the substances. The fish and daphnid tests should be conducted with
flow-through methods and measured concentrations. The algal test should
be conducted with static methods and measured concentrations.
CFR citation: 40 CFR 721.4486.
PMN Number P-98-0823
Chemical name: Dodecanoic acid, 12-amino-.
CAS number: 693-57-2.
Effective date of section 5(e) consent order: August 18, 2000.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health and the environment.
Toxicity concern: This PMN substance will be used as a raw material for
Nylon-12. EPA has identified a health concern for carcinogenicity via
inhalation exposure based on analogy to 11-aminoundodecanoic acid which
caused neoplastic nodules in the liver and transitional cell carcinomas
in the urinary bladder of male rats.
Recommended testing: EPA has determined that a carcinogenicity study
(OPPTS 870.4200 test guideline) would help to characterize the human
health effects.
CFR citation: 40 CFR 721.2584.
PMN Number P-98-1125
Chemical name: (generic) Fatty acid, reaction product with substituted
oxirane, formaldehyde-phenol polymer glycidyl ether, substituted
propylamine and polythylenepolyamines.
CAS number: Not available.
Basis for action: The PMN substance will be used as a curing agent for
epoxy coating systems. Based on structural analogy to aliphatic amines,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 10 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 10 ppb, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and 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 above 10 ppb may cause significant adverse
environmental effects. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)); a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), an algal
toxicity study (OPPTS 850.5400 test guideline (public draft)), and a
fish acute toxicity mitigated by humic acid (`HA') of 10 and 20 mg HA
per liter diluent would help to characterize the environmental effects
of the PMN substance. All studies should use the static methods and
nominal concentrations.
CFR citation: 40 CFR 721.6181.
PMN Number P-98-1262
Chemical name: (generic) Reaction product of alkylene diamine, MD1,
substituted carbomonocyclic amine and alkylamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on test data on structurally similar neutral organic
chemicals, the PMN substance may cause toxicity to aquatic organisms.
Based on the data, EPA is concerned that toxicity to aquatic organisms
may occur at a concentration as low as 1 ppb of the PMN substance in
surface waters. Since significant environmental exposure is not
expected, as the substance is not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and 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 the
following testing would help characterize the environmental effects of
the PMN substance: a Melting point (OPPTS 830.7200 test guideline), a
fish early-life stage toxicity test (OPPTS 850.1400 test guideline
(public draft)), and a daphnid chronic toxicity test
[[Page 15066]]
(OPPTS 850.1300 test guideline (public draft)). The fish and daphnid
tests should be conducted with the flow-through methods and measured
concentrations, and hardness of dilution water less than 180 mg/L as
CaC03.
CFR citation: 40 CFR 721.2582.
PMN Number P-99-0044
Chemical name: Formaldehyde, polymer with phenol and 1,2,3-
propanetriol, methylated.
CAS number: 209810-57-1.
Basis for action: The PMN substance will be used as a bonding agent for
mineral aggregates. Based on structural analogy to phenols, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 2 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 3 ppb, as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in releases to surface water above 3 ppb may cause 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 activated sludge
sorption isotherm test (OPPTS 835.1110 test guideline), a fish acute
toxicity study (OPPTS 850.1075 test guideline (public draft)), a
daphnid acute toxicity study (OPPTS 850.1010 test guideline (public
draft)), and an algal toxicity study (OPPTS 850.5400 test guideline
(public draft)) would help characterize the environmental effects of
the PMN substance. The fish and daphid tests should be performed under
flow through methods and measured concentrations. The algal test should
be performed under static methods and measured concentrations.
CFR citation: 40 CFR 721.3807.
PMN Number P-99-0510
Chemical name: (generic) Hexamethylenediamine adduct of substituted
piperidinyloxy.
CAS number: Not available.
Effective date of section 5(e) consent order: December 24, 1999.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(i) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health.
Toxicity concern: Based on submitted data on a 28-day subchronic study
in rats, the PMN substance has been shown to cause potential liver
toxicity, hemolytic effects, and immunotoxicity from inhalation
exposure to the PMN substance.
Recommended testing: A 90-day subchronic oral study in rats with
emphasis on hematology, the immune system, and male reproductive system
(OPPTS 870.3100 test guideline) would help to characterize possible
effects of the substance. The PMN submitter has agreed not to exceed
the production volume limit without performing the 90-day subchronic
oral study.
CFR citation: 40 CFR 721.6205.
PMN Number P-99-0669
Chemical name: Oxirane, methyl-, polymer with oxirane, mono(3,5,5,-
trimethylhexyl) ether.
CAS number: 204336-40-3.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to nonionic surfactants, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration of 600 ppb in surface waters. Since significant
environmental exposure is unlikely, as the substance is not released to
surface waters, as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the substance resulting in 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 a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substances. The fish and daphnid tests should be conducted with the
flow-through methods and measured concentrations, and the algal test
should be conducted with static methods and measured concentrations.
CFR citation: 40 CFR 721.522.
PMN Number P-99-0848
Chemical name: (generic) Alkenyl carboxylate, metal salt.
CAS number: Not available.
Effective date of section 5(e) consent order: August 2, 2000.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance is expected to enter the environment in
substantial quantities and may present an unreasonable risk of injury
to the environment.
Toxicity concern: Based on analogy to anionic surfactants the PMN
substance may be toxic to aquatic organisms at concentrations as low as
1 ppb.
Recommended testing: EPA has determined that an algal toxicity study
(OPPTS 850.5400 test guideline (public draft)), an daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
fish acute toxicity study (OPPTS 850.1075 test guideline (public
draft)) would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations and hardness of dilution
water with less than 180 mg/L as CaC03. The algal test
should be conducted with static methods and measured concentrations.
The PMN submitter has agreed not to exceed the production volume limit
without performing these tests.
CFR citation: 40 CFR 721.2093.
PMN Number P-99-0873
Chemical name: (generic) Propanetriol polyalkylenepolyolamine aryl
aldimine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a binder for
industrial coating. Based on additional information and structural
analogy to schiff bases and aliphatic amines, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 2
ppb of the PMN substance in surface waters. Since significant
environmental exposure is not expected, as the substance is not
released to surface waters, EPA has not determined that the proposed
manufacturing, processing, and 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 study
(OPPTS 850.5400 test guideline (public draft)), a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid chronic
toxicity study (OPPTS 850.1300 test guideline (public draft)) would
help to characterize the environmental effects of the PMN substance.
The fish and daphnid tests should be conducted with the flow-through
methods and measured concentrations and the algal test should be
conducted with static methods and measured concentrations.
[[Page 15067]]
CFR citation: 40 CFR 721.910.
PMN Number P-99-0874
Chemical name: (generic) Modified polymer of vinyl acetate and
quaternary ammonium compound.
CAS number: Not available.
Basis for action: The PMN substance will be used as a modified
polyvinyl alcohol. Based on submitted toxicity data for other high
molecular weight, water swellable polymers, EPA has identified health
concerns for inhalation exposure. Since significant inhalation exposure
is unlikely when the substance is used as identified in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture of the PMN may lead to inhalation
exposure which could 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 with a 60-day holding period (OPPTS 870.3465 test
guideline) would help to characterize the human health effects of the
PMN substance. Attention should be given to the lungs, including
histopathology of the lungs (inflamation, epithelial hyperplasia, and
fibrosis), bronchoalvelar lavage (BAL) analysis for markers of lung
injury, and lung burden analysis for clearance of the test material
(EPA-748-R-96-001). The neurotoxicity components and examination of
organs other than the lungs are not required.
CFR citation: 40 CFR 721.8658.
PMN Number P-99-0965
Chemical name: Furan, octafluorotetrahydro-.
CAS number: 773-14-8.
Basis for action: The PMN substance will be used as heat transfer
agent. EPA believes that other uses of the PMN substance are likely and
they have the potential for more widespread environmental exposure
causing potential atmospheric changes. EPA is concerned that such
atmospheric changes may contribute to global warming. Since significant
environmental exposure is unlikely, as described in the PMN, EPA has
not determined that the proposed manufacturing, processing, and use of
the substance may present an unreasonable risk. EPA has determined,
however, that other uses of the 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 infrared absorption,
destruction of OH by radical and rate of production of HF for global
warming would help to characterize the atmospheric effects of the PMN
substance.
CFR citation: 40 CFR 721.3818.
PMN Number P-99-0990
Chemical name: Cobaltate (5-), bis[4-[[6-[(4-amino-6-chloro-1,3,5-
triazin-2-yl)amio]-1-hydroxy-3-sulfo-2-naphthalenyl]azo]-3-hydroxy-7-
nitro-1-naphthalenesulfonato(4-)]-, pentasodium.
CAS number: 91144-26-2.
Basis for action: Based on structural analogues and submitted test
data, EPA has identified health concerns for carcinogenicity and
mutagenicity from inhalation exposure to the PMN substance. Since
significant worker exposure is unlikely because inhalation exposure is
not expected when the substance is used with protective equipment as
identified in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that uses of the
substance other than as described in the PMN may cause serious health
effects. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(1)(i)(B) and (b)(1)(i)(C).
Recommended testing: EPA has determined that a combined chronic
toxicity/carcinogenicity study (OPPTS 870.4300 test guideline) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5283.
PMN Number P-99-1167
Chemical name: L-aspartic acid, N,N'- [(1E) - 1,2 - ethenediylbis[(3-
sulfo-4, 1-phenylene)imino[6-(phenylamino)- 1,3,5-triazine-4,2 -
diyl]]]bis-, hexasodium salt.
CAS number: 205764-98-3.
Basis for action: The PMN substance will be used as a fluorescent
whitener for coated paper. Based on submitted test data, EPA has
identified concerns for liver effects. Since significant worker
exposure is unlikely because there would not be significant inhalation
exposure for the use identified in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the substance as
described in the PMN present an unreasonable risk. EPA has determined,
however, that uses of the substance in a powder form or domestic
manufacture 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 subchronic oral
toxicity study in rodents (OPPTS 870.3100 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.4575.
PMN Number P-99-1189
Chemical name: 2-propenoic acid, 2-methyl-, C11-14-isoalkyl
esters, C13-rich.
CAS number: 85736-97-6.
Basis for action: The PMN substance will be used as a monomer for
casting automotive parts adhesives or as an impregnation fluid. Based
on analogy to structurally similar methacrylates and esters, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected, as the
substance is not released to surface waters above 1 ppb, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and 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 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: The Agency has determined that the results of the
following testing would help to characterize possible environmental
effects of the substance: A ready biodegradability test (OPPTS 835.3110
test guideline); a fish early-life stage toxicity study (OPPTS 850.1400
test guideline (public draft)); a mysid chronic toxicity study (OPPTS
850.1350 test guideline (public draft)) for 21 days, flow-through
methods and measured concentrations; and a saltwater algal toxicity
study, tiers I and II (OPPTS 850.5400 test guideline (public draft))
with the static methods and measured concentrations.
CFR citation: 40 CFR 721.4792.
PMN Numbers P-99-1191 and P-99-1192
Chemical name: (generic) Rare earth phosphate.
CAS number: Not available.
Basis for action: The PMN substances will be used as phosphors. Based
on structural analogy to soluble salts and test data for inorganic
phosphates, EPA is concerned that toxicity to aquatic organisms may
occur at a concentration as low as 2 ppb of the PMN substances in
surface waters. Since significant environmental exposure is not
expected, as the substances are not released to
[[Page 15068]]
surface waters above 10 ppb, as described in the PMNs, EPA has not
determined that the proposed manufacturing, processing, and 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 above 10 ppb may cause significant adverse environmental
effects. Based on this information the PMN substances meet the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substances. A flow-through method with measured concentrations of the
rare earth metal is recommended for the fish and daphnid study and the
static method with measured concentrations for green algae. In
addition, the test dilution water and/or test medium should have a
measured hardness of less than 180.0 mg/L as CaC03 and a
total organic carbon (TOC) concentration of less than 2.0 mg TOC/L.
CFR citation: 40 CFR 721.6005.
PMN Number P-99-1287
Chemical name: (generic) Alkylaminated polyolefin.
CAS number: Not available.
Basis for action: The PMN substance will be used as a gasoline fuel
additive. Based on structural analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 40 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected, as the
substance is not released to surface waters, as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. These tests should be conducted with static methods and
nominal concentrations, total organic carbon TOC of dilution water <
2.0 mg TOC/L, hardness of dilution water < 180.0 mg/L as
CaC03, and stock solution adjusted to pH 7.0 with HCl.
CFR citation: 40 CFR 721.6178.
PMN Number P-99-1327
Chemical name: Propane, 1,1,1,3,3-pentachloro-.
CAS number: 23153-23-3.
Basis for action: The PMN substance will be used as an intermediate for
hydrofluorocarbon production. Based on submitted test data, EPA has
identified health concerns for carcinogenicity, liver and kidney
toxicity. Based on submitted data on hexachloropropane, concern for
immunotoxicity was identified. Also, the Agency identified concern for
neurotoxicity, reproductive toxicity in males and females, and concern
for irritation and lesions in nasal passages and respiratory passages
based on test data on other structural analogues. Since significant
worker exposure is unlikely when the substance is used as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and 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 serious
health effects. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170(b)(1)(i)(A), (b)(3)(i), and
(b)(3)(ii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study (OPPTS 870.3700 test guideline), carcinogenicity study
(OPPTS 870.4200 test guideline), and a reproduction fertility effects
study (OPPTS 870.3800 test guideline) by the inhalation route will help
to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.533.
PMN Number P-99-1346
Chemical name: Silane, triethoxy (3,3,4,4,5,5,6,6,7,7,8,8,8-
tridecafluorooctyl)-.
CAS number: 51851-37-7.
Basis for action: The PMN substance will be used as in anti-graffiti
coatings as described in the PMN. Based on structural analogy to
alkoxysilanes, EPA has identified health concerns for lung toxicity.
Since significant worker exposure is unlikely, when the substance is
used with protective equipment as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that use of the PMN substance other than as described in the
PMN 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 subchronic
inhalation toxicity study in rats (OPPTS 870.3465 test guideline) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9504.
PMN Number P-99-1366
Chemical name: (generic) 4,6-Disubstituted pyrimidine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a starting material
for synthesis of a chemical intermediate. EPA has identified health
concerns for neurotoxicity and immunotoxicity (effects to the spleen)
based on test data on an analogous substance, concerns for
carcinogenicity and developmental toxicity based on the potential for
the PMN substance to act as an arylating agent or as an antimetabolite.
Since significant worker exposure is unlikely, when the substance is
used as described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture could result in exposures which may cause serious chronic
and developmental effects. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(3)(ii) and (b)(1)(i)(C).
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study in rodents (OPPTS 870.3100 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.8920.
PMN Number P-99-1399
Chemical name: (generic) Aromatic epoxide resin.
CAS number: Not available.
Basis for action: The PMN substance will be used as a thermoset resin.
EPA has identified health concerns for mutagenicity, carcinogenicity,
developmental toxicity, male reproductive effects, liver and kidney
toxicity based on the epoxide groups. Since significant worker exposure
is unlikely, when the substance is used as described in the PMN, EPA
has not determined that the proposed
[[Page 15069]]
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
substance other than as described in the PMN may cause serious health
effects. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study in rodents with attention to pathology of the
reproductive organs (OPPTS 870.3100 test guideline), a reproduction
fertility effects study (OPPTS 870.3800 test guideline), and a combined
chronic toxicity/carcinogenicity study (OPPTS 870.4300 test guideline)
would help to characterize the health effects of the substance.
CFR citation: 40 CFR 721.2673.
PMN Number P-00-0045
Chemical name: (generic) Benzenediazonium, [[[[(substituted)
azo]phenyl]sulfonyl]amino]-, coupled with aminophenol, diazotized
aminobenzoic acid, diazotized (substituted) benzenesulfonic acid and
naphthalenol.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on submitted test data, EPA has identified health concerns
for methemoglobinemia. Since significant worker exposure is unlikely
when used as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the substance may cause
significant adverse effects. EPA has determined, however, that domestic
manufacture may result in serious health effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study in rodents (OPPTS 870.3100 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5286.
PMN Number P-00-0067
Chemical name: (generic) Alkyl heteropolycyclic-aniline.
CAS number: Not available.
Basis for action: The PMN substance will be used as an industrial
intermediate. Based on test data and on structural analogy to anilines,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the
substance is not released to surface water above 1 ppb as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in release to surface 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)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that a daphnid chronic toxicity
test (OPPTS 850.1300 test guideline (public draft)), a fish early-life
stage toxicity test (OPPTS 850.1400 test guideline (public draft))
conducted with flow-through methods and measured concentrations,
dilution water hardness < 180.0 mg/L as CaC03, and a Porous
Pot (OPPTS 835.3220 test guideline) would help to characterize the
environmental effects.
CFR citation: 40 CFR 721.4136.
PMN Number P-00-0094
Chemical name: (generic) Salt of a substituted sulfonated aryl azo
compound.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant for
coating compositions. EPA has identified health concerns for testicular
effects, blood effects, and liver toxicity based on submitted test
data. Since significant worker exposure is unlikely, when the substance
is used as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined however, that domestic
manufacture 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)(i).
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study in rodents (OPPTS 870.3100 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9597.
PMN Number P-00-0108
Chemical name: (generic) Alkoxyamino-alkyl-coumarin.
CAS number: Not available.
Basis for action: The PMN substance will be used as a chemical tracer.
Based on structural analogy to coumarins, EPA has identified health
concerns for developmental toxicity and carcinogenicity. Since
significant worker exposure is unlikely when the substance is used as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture 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) and (b)(1)(i)(C).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rodents (OPPTS 870.3100 test guideline) and a prenatal
developmental toxicity study (OPPTS 870.3700 test guideline) would help
to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.2155.
PMN Number P-00-0202
Chemical name: (generic) Reaction product of substituted aromatic diol,
formaldehyde and alkanolamine, propoxylated.
CAS number: Not available.
Basis for action: The PMN substance will be used as foam insulation.
Based on structural analogy to aliphatic amines, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 10
ppb of the PMN substance in surface waters. Since significant
environmental exposure is not expected, as the substance is not
released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in release 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 acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. All tests should be conducted with static methods and
nominal concentrations, dilution water total organic carbon TOC < 2.0
mg TOC/L dilution water hardness < 180.0 mg/L as CaC03, and
stock solution adjusted to pH 7.0.
CFR citation: 40 CFR 721.8085.
PMN Number P-00-0330
Chemical name: Oxirane, [[[(1R,2S,5R)-5-methyl-2-(1-
methylethyl)cyclohexyl]oxy]methyl]-.
CAS number: 249297-16-3.
[[Page 15070]]
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on data for monoepoxides, EPA has identified health
concerns for mutagenicity, carcinogenicity, male reproductive toxicity,
developmental toxicity, and liver and kidney toxicity for the epoxide.
Also, based on analogy to epoxides, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 30 ppb of the
PMN substance in surface waters. Since significant worker and
environmental exposure is unlikely when the substance is used as
described in the PMN, EPA has not determined that the manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that use of the substance other than
as an intermediate could result in exposures which may cause serious
health effects and significant adverse environmental effects. Based on
this information the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii), (b)(1)(i) (C), and (b)(4)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study in rodents (OPPTS 870.3100 test guideline), with
attention to pathology of the reproductive organs, and a
carcinogenicity study (OPPTS 870.4200 test guideline) would help to
characterize the health effects of the substance. In addition, the
following acute aquatic toxicity tests would help to characterize the
environmental effects. A fish acute toxicity study (OPPTS 850.1075 test
guideline (public draft)), a daphnid acute toxicity study (OPPTS
850.1010 test guideline (public draft)), and an algal toxicity study
(OPPTS 850.5400 test guideline (public draft)). The fish and daphnid
tests should be conducted with flow-through methods and measured
concentrations. The algal test should be conducted with static methods
and measured concentrations.
CFR citation: 40 CFR 721.5590.
PMN Numbers P-00-0333 and P-00-0334
Chemical name: (generic) Salt of an acrylate copolymer.
CAS number: Not available.
Basis for action: The PMN substances will be used as an additive. EPA
has identified concerns for lung toxicity and lung tumors based on data
on certain high molecular weight polymers. Since significant worker
exposure is unlikely as inhalation exposure is not expected for the
uses described in the PMNs, EPA has not determined that the proposed
manufacturing, processing, and use of the substances may present an
unreasonable risk. EPA has determined, however, that uses of the
substances in a solid form may cause serious health effects. Based on
this information the PMN substances meet the concern criteria at Sec.
721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation
toxicity study with a 60-day holding period (OPPTS 870.3465 test
guideline) would help characterize the human health effects of the PMN
substance. Attention should be given to the lungs, including
histopathology of the lungs (inflamation, epithelial hyperplasia, and
fibrosis), bronchoalvelar lavage (BAL) analysis for markers of lung
injury, and lung burden analysis for clearance of the test material
(EPA-748-R-96-001). The neurotoxicity components and examination of
organs other than the lungs are not required.
CFR citation: 40 CFR 721.338.
PMN Number P-00-0351
Chemical name: (generic) Amino-hydroxy sulfonaphthylazo-disubstituted
phenyl azo benzene carboxylate salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on submitted data on a 28-day study in rats with a no
observed adverse effect level (NOAEL) of 25 mg/kg/day, EPA has
identified concerns for liver and kidney effects. Additionally, based
on analogy of the azo reduction product of the PMN substance, EPA has
concerns for carcinogenicity, developmental toxicity, and
immunotoxicity. Since significant worker exposure is unlikely as
inhalation exposure is not expected for the use described in the PMN,
EPA has not determined that manufacturing, processing, and use of the
substance as described in the PMN may present an unreasonable risk. EPA
has determined, however, that 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)(3)(ii), (b)(3)(iii), and
(b)(1)(i)(D).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two species (OPPTS 870.3700 test
guideline) and an Ames assay with the Prival modification and a
concurrent positive control (OPPTS 870.5100 test guideline) would help
to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.984.
PMN Number P-00-0353
Chemical name: (generic) Alkoxylated aliphatic diisocyanate allyl
ether.
CAS number: Not available.
Basis for action: The PMN substance will be used as an additive for
surface coatings and for plastics and plastic surfaces. Based on
structural analogy to esters and allylic and vinyl ethers, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 9 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected, as the PMN
substance is not released to surface waters, as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
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 chronic toxicity
study (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic
toxicity study (OPPTS 850.1300 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations, dilution water hardness
less than 180.0 mg/L as CaC03. The algal test should be
conducted with static methods and measured concentrations.
CFR citation: 40 CFR 721.9952.
PMN Numbers P-00-0364 and P-00-0365
Chemical name: (generic) Copper complex of (substituted sulfonaphthyl
azo substituted phenyl) disulfonaphthyl azo, amine salt.
CAS number: Not available.
Basis for action: The PMN substances will be used as described in the
PMNs. Based on analogy to structurally similar substances, EPA has
identified concerns for mutagenicity, carcinogenicity, and
developmental toxicity. Since significant worker exposure is unlikely
as inhalation exposure is not expected for the uses described in the
PMNs, EPA has not determined that the proposed manufacturing,
processing, and use of the substances may present an unreasonable risk.
EPA has determined, however, that use of the substances as a powder may
cause serious health effects. Based on this information the PMN
substances meet the concern criteria at Sec. 721.170(b)(3)(ii) and
(b)(1)(i)(C).
Recommended testing: EPA has determined that a prenatal
[[Page 15071]]
developmental toxicity study by the oral route in two species (OPPTS
870.3700 test guideline) would help to characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.2577.
PMN Number P-00-0420
Chemical name: (generic) Substituted phenylazophenylazo phenol.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant. Based
on structural analogy to phenols, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 1 ppb of the
PMN substance in surface waters. Since significant environmental
exposure is not expected, as the substance is not released to surface
waters, as described in the PMN, EPA has not determined that the
proposed manufacturing, processing and use of the substance may present
an unreasonable risk. EPA has determined, however, that other uses of
the substance resulting in release 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 acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations. The algal test should be
conducted with static methods and measured concentrations. Dilution
water hardness less than 180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.843
PMN Number P-00-0469
Chemical name: Glycine, N-(carboxymethyl)-N-dodecyl-, monosodium salt.
CAS number: 141321-68-8.
Basis for action: The PMN substance will be used as a surfactant. Based
on structural analogy to alkyl amphoteric surfactants, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 30 ppb of the PMN substance in surface waters. Since significant
environmental exposure is not expected as the PMN substance is not
released to surface water above 30 ppb, as described in the PMN, EPA
has not determined that the proposed manu-facturing, processing, and
use of the substance may present an unreasonable environmental risk.
EPA has determined, however, that other uses of the substance resulting
in release to surface water above 30 ppb may cause significant adverse
environmental effects. Based on this infor-mation the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the following acute
aquatic toxicity tests would help to characterize the environmental
effects: a fish acute toxicity study (OPPTS 850.1075 test guideline
(public draft)), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline (public draft)), and an algal toxicity study (OPPTS 850.5400
test guideline (public draft)). The fish and daphnid tests should be
conducted with flow-through methods and measured concentrations. The
algal test should be conducted with static methods and measured
concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/L
dilution water hardness < 180.0 mg/L as CaC03, and stock
solution adjusted to pH 7.0.
CFR citation: 40 CFR 721.3848.
PMN Number P-00-0490
Chemical name: (generic) Substituted acrylamides and acrylic acid
copolymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as a delivery
substrate. EPA has identified concerns for lung toxicity and
carcinogenicity if the substance is inhaled based on data for certain
high molecular weight polymers. Since significant worker exposure is
unlikely as inhalation exposure to worker is not expected for the use
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substances may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture, or processing and use of the substance in a powder form
may cause serious health effects. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii) and
(b(1)(i)(C).
Recommended testing: EPA has 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 of the PMN
substance. Attention should be given to the lungs, including
histopathology of the lungs (inflamation, epithelial hyperplasia, and
fibrosis), bronchoalvelar lavage (BAL) analysis for markers of lung
injury, and lung burden analysis for clearance of the test material
(EPA-748-R-96-001). The neurotoxicity components and examination of
organs other than the lungs are not required.
CFR citation: 40 CFR 721.321.
PMN Number P-00-0542
Chemical name: (generic) Substituted phenols and formaldehyde polymer,
alkylated.
CAS number: Not available.
Basis for action: The PMN substance will be used as a resin for can and
tube coatings. Based on structural analogy to polyphenol reaction
products, EPA is concerned that toxicity to aquatic organisms may occur
at a concentration as low as 4 ppb of the PMN substance in surface
waters. Since significant environmental exposure is unlikely, as the
substance is not released to surface waters, as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
use of the substance may prevent an unreasonable risk. EPA has
determined, however, that other uses of the substance resulting in
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 a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentration. The algal test should be
conducted with static methods and measured concentration. Dilution
water hardness < 180 mg/L as CaC03.
CFR citation: 40 CFR 721.3812.
PMN Number P-00-0559
Chemical name: (generic) Methylated-para-rosaniline salt of a
trisulfonated triarylmethane dye.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant for
inks. EPA has identified health concerns for carcinogenicity and
developmental toxicity based on analogy to gentian violet. Since
significant worker exposure is unlikely when the substance is used as
described in the PMN, EPA has not determined that the proposed
processing and use of the substance may present a unreasonable risk.
EPA has determined however, that domestic manufacturing could result in
exposures which may cause serious health effects. Also, based on
analogy to cationic dyes. EPA is also concerned that toxicity to
aquatic organisms may occur at a concentration as low as 2 ppb of the
[[Page 15072]]
PMN substance in surface waters. Since significant environmental
exposure is not expected as the PMN substance is not released to
surface water above 2 ppb, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable environmental risk. EPA has
determined, however, that other uses of the substance resulting in
release to surface water 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)(1)(i)(C), (b)(3)(ii),
and (b)(4)(ii).
Recommended testing: EPA has determined that the following acute
aquatic toxicity tests would help to characterize the environmental
effects: a fish acute toxicity study (OPPTS 850.1075 test guideline
(public draft)), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline (public draft)), and an algal toxicity study (OPPTS 850.5400
test guideline (public draft)). The fish and daphnid tests should be
conducted with flow-through methods and measured concentrations,
dilution water total organic carbon TOC < 2.0 mg TOC/L. The algal test
should be conducted with static methods and measured concentration.
Dilution water hardness < 180.0 mg/L as CaC03. EPA has also
determined that a prenatal developmental toxicity study by the oral
route in two-species (OPPTS 870.3700 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9520.
PMN Number P-00-0618
Chemical name: (generic) Substituted hydroxyalkane acetate.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has concerns for liver toxicity, kidney toxicity, and
developmental toxicity based on a 28-day subchronic inhalation study in
rats and a developmental toxicity study in rats for an analog of the
PMN material; EPA identified concerns for neurotoxicity and
carcinogenicity based on analog data. Since significant worker exposure
is unlikely as inhalation exposure is not expected for the use
described in the PMN, EPA has not determined that manufacturing,
processing, and use of the substance as described in the PMN may
present an unreasonable risk. EPA has determined, however, that use of
the substance other than as described in the PMN may cause serious
health effects. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170 (b)(3)(i), (b)(3)(ii), and
(b)(1)(i)(C).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two species (OPPTS 870.3700 test
guideline) and a 90-day inhalation toxicity study with a 60-day holding
period (OPPTS 870.3465 test guideline) would help to characterize the
human health effects of the PMN substance.
CFR citation: 40 CFR 721.532.
PMN Number P-00-0626
Chemical name: (generic) Acrylate of polymer based on isophorone
diisocyanate.
CAS number: Not available.
Basis for action: The PMN substance will be used as an additive for
inks and coatings. Based on structural analogy to acrylates, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 3 ppb, as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable
environmental risk. EPA has determined, however, that other uses of the
substance resulting in release to surface water above 3 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 following acute
aquatic toxicity tests would help to characterize the environmental
effects: a fish acute toxicity study (OPPTS 850.1075 test guideline
(public draft)), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline (public draft)), and an algal toxicity study (OPPTS 850.5400
test guideline (public draft)). The fish and daphnid tests should be
conducted with flow-through methods and measured concentrations The
algal test should be conducted with static methods and measured
concentrations. Dilution water hardness < 180.0 mg/L as
CaC03.
CFR citation: 40 CFR 721.463.
PMN Number P-00-0637
Chemical name: Methylium, triphenyl-, tetrakis(pentafluorophenyl)borate
(l-).
CAS number: 136040-19-2.
Basis for action: The use of the substance is as described in the PMN.
Based on structural analogy to organoborates, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 1
ppb of the PMN substance in surface waters. Since significant
environmental exposure is not expected, as the substance is not
released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and 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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations. The algal test should be
conducted with static methods and measured concentrations. Dilution
water hardness less than 180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.5454.
PMN Number P-00-0638
Chemical name: (generic) Alkali metal salt of halogenated organoborate.
CAS number: Not available.
Basis for action: The use of the substance is as described in the PMN.
Based on structural analogy to organoborates, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 3
ppb of the PMN substances in surface waters. Since significant
environmental exposure is not expected, as the substance is not
released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and 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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and
[[Page 15073]]
daphnid tests should be conducted with flow-through methods and
measured concentrations. The algal test should be conducted with static
methods and measured concentrations. Dilution water hardness less than
180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.5452.
PMN Number P-00-0691
Chemical name: Amides, from ammonium hydroxide - maleic anhydride
polymer and hydrogenated tallow alkyl amines, sodium salts, compds.
with ethanolamine.
CAS number: 208408-03-1.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to anionic surfactants. EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 80 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 80 ppb, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, other uses of the substance resulting in
release to surface waters above 80 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 following acute
aquatic toxicity tests would help to characterize the environmental
effects: a fish acute toxicity study (OPPTS 850.1075 test guideline
(public draft)), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline (public draft)), and an algal toxicity study (OPPTS 850.5400
test guideline (public draft)). The fish and daphnid tests should be
conducted with flow-through methods and measured concentrations. The
algal test should be conducted with static methods and measured
concentrations. Dilution water hardness < 180.0 mg/L as
CaC03.
CFR citation: 40 CFR 721.6183.
PMN Number P-00-0698
Chemical name: (generic) Lithium salt of a sulfophenyl azo phenyl azo
disulfostilbene.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to structurally similar substance, EPA has
identified concerns for liver toxicity, developmental toxicity,
neurotoxicity, and blood toxicity for the aromatic amine azo reduction
product. Since significant worker exposure is unlikely as inhalation
exposure is not expected for the uses described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that 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)(3)(iii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two species (OPPTS 870.3700 test
guideline) and a 90-day subchronic oral toxicity study in rodents
(OPPTS 870.3100 test guideline) would help to characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.9538.
PMN Number P-00-0738
Chemical name: Formaldehyde, reaction products with 1,3-
benzenedimethanamine and bisphenol A.
CAS number: 259871-68-6.
Basis for action: The PMN substance will be used as coatings for
railcars and marine vessels. Based on structural analogy to phenols and
aliphatic amines, EPA is concerned that toxicity to aquatic organisms
may occur at a concentration as low as 20 ppb of the PMN substance in
surface waters. Since significant environmental exposure is not
expected as the PMN substance is not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in 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 a fish acute toxicity
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. These tests should be conducted with the static methods and
nominal concentrations, dilution water total organic carbon TOC < 2.0
mg TOC/L dilution water hardness < 180.0 mg/L as CaC03, and
stock solution adjusted to pH 7.0. EPA has also determined that an
activated sludge isotherm test (OPPTS 835.1110 test guideline) would
help to characterize the environmental fate of the PMN substance.
CFR citation: 40 CFR 721.3805.
PMN Number P-00-0789
Chemical name: 1,4-Benzedicarboxylic acid, dimethyl ester, polymer with
1,4 - butanediol, cyclized.
CAS number: 263244-54-8.
Basis for action: The PMN substance will be used as a curable
thermoplastic resin. EPA has identified health and environmental
concerns because the substance is potentially a persistent,
bioaccumulative, and toxic (PBT) chemical, EPA estimates that the PMN
substance will persist in the environment more than two months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Also based on structural analogy to esters, EPA expects toxicity to
aquatic organisms at surface water concentrations as low as 9 ppb.
Since significant environmental exposure is not expected as the
substance is not released to surface waters, described in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in release to
surface water may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemicals Program's PBT Policy
Statement (63 FR 60194; November 4, 1999) (FRL-6097-7) would help to
characterized the properties of the substance. EPA has also determined
that the following aquatic toxicity tests: a fish chronic toxicity
study (OPPTS 850.1400 test guideline (public draft)), a daphnid chronic
toxicity study (OPPTS 850.1300 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations. The algal test should be
conducted with static methods and measured concentrations. Dilution
water hardness < 180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.990.
PMN Number P-00-0803
Chemical name: (generic) 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-
6-[substituted] amino]-1,3,5-
[[Page 15074]]
triazin-2-yl]amino]-4-hydroxy-3-[(1-sulfo-2-naphthalenyl)azo]-,
trisodium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a textile dye. EPA
has identified health concerns for mutagenicity and developmental
toxicity based on one of the substituents on an azo reduction product.
Since significant worker exposure is unlikely when the substance is
used as described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture 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)(iii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in rats (OPPTS 870.3700 test
guideline) would help to characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.5262.
PMN Number P-00-0806
Chemical name: 1,3,6-Naphthalenetrisulfonic acid, 7-[[2-
[(aminocarbonyl)amino]-4-[[4-[[2-[2-
(ethenylsulfonyl)ethoxy]ethyl]amino]-6-fluoro-1,3,5-triazin-2-
yl]amino]phenyl]azo], trisodium salt.
CAS number: 106359-91-5.
Basis for action: The PMN substance will be used as a textile dye.
Based on submitted test data, EPA has identified health concerns for
mutagenicity, dermal sensitization and possible irreversible cornea
staining; developmental toxicity and carcinogenicity based on one of
the substituents on an azo reduction product. Since significant worker
exposure is unlikely when the substance is used as described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that domestic manufacture 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)(i), (b)(l)(i)(D), and (b)(3)(iii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in rats (OPPTS 870.3700 test
guideline) would help to characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.5260.
PMN Number P-00-0816
Chemical name: (generic) Alkyl dialkylamino phenylsulfonyl alkenoate.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on test data for structurally similar compounds, EPA has
identified health concerns for kidney and liver toxicity. Since
significant worker exposure is unlikely when the substance is used as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture 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)(i). Also, based on structural analogy
to aliphatic amines, acrylates, and allylic and vinyl sulfones, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the
substance is not released to surface waters, as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
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 90-day subchronic oral
study in rats (OPPTS 870.3100) would help characterize the human health
effects of the PMN substance. Also the following aquatic toxicity test
would help characterize the environmental effects of the PMN substance:
a fish acute toxicity study (OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (OPPTS 850.1010 test guideline
(public draft)), and an algal toxicity study (OPPTS 850.5400 test
guideline (public draft)). The fish and daphnid tests should be
conducted with flow-through methods and measured concentrations. The
algal test should be conducted with static methods and measured
concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/L
dilution water hardness < 180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.648.
PMN Number P-00-0827
Chemical name: 1-propanol, 3-propoxy-.
CAS number: 4161-22-2.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for liver toxicity based on
submitted test data and neurotoxicity based on the solvent properties
of the substance. Since significant worker exposure is unlikely, when
the substance is used with protective equipment as described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, and 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 including handling the material without the use of
impervious gloves 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)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study (OPPTS 870.3100 test guideline), and a prenatal developmental
toxicity study (OPPTS 870.3700 test guideline) would help to
characterize the health effects of the substance.
CFR citation: 40 CFR 721.525.
PMN Number P-00-0922
Chemical name: Borate(1-), tris(acetato-.kappa.O)hydro-, sodium, (T-
4)-.
CAS number: 56553-60-7.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to other boron compounds, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 300 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 300 ppb, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in release to surface water above 300 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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to
[[Page 15075]]
characterize the environmental effects of the PMN substance. The fish
and daphnid tests should be conducted with flow-through methods and
measured concentrations. The algal test should be conducted with static
methods and measured concentrations. Dilution water hardness less than
180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.1880.
PMN Number P-00-0993
Chemical name: (generic) Substituted 6,6'-(1-methylethylidene)bis[3,4-
dihydro-3-phenyl-1,3-benzoxazine].
CAS number: Not available.
Basis for action: The PMN substance will be used as resin for
structural composites and electronic laminates. EPA has identified
health and environmental concerns because the substance is potentially
a PBT chemical. Since significant environmental exposure is not
expected, as the substance is not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in 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 tiered
testing as described in the New Chemicals Program's PBT Category (63 FR
60194; November 4, 1999) would help to characterized the properties of
the substance. EPA has also determined that the results of the
following aquatic toxicity tests: a fish chronic toxicity study (OPPTS
850.1400 test guideline (public draft)), a daphnid chronic toxicity
study (OPPTS 850.1300 test guideline (public draft)), and an algal
toxicity study (OPPTS 850.5400 test guideline (public draft)), would
help to characterize the environmental effects of the PMN substance.
The fish and daphnid tests should be conducted with flow-through
methods and measured concentrations, dilution water hardness < 180.0
mg/L as CaC03. The algal test should be conducted with
static methods and measured concentrations.
CFR citation: 40 CFR 721.1767
PMN Number P-00-1086
Chemical name: (generic) Silyl amine, potassium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to aliphatic amines, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 10 ppb of the PMN substance in surface waters. Since significant
environmental exposure is not expected as the PMN substance is not
released to surface waters as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and 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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentrations. The algal test should be
conducted with static methods and measured concentrations, dilution
water total organic carbon TOC < 2.0 mg TOC/L dilution water hardness <
180.0 mg/L as CaC03.
CFR citation: 40 CFR 721.638.
PMN Number P-00-1087
Chemical name: (generic) Di-alkyl borane.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to organoborane compounds, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 200 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected as the PMN
substance is not released to surface water above 200 ppb, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and 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 above 200 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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentration. The algal test should be
conducted with static methods and measured concentration. Dilution
water hardness < 180 mg/L as CaC03.
CFR citation: 40 CFR 721.1852.
PMN Number P-00-1089
Chemical name: (generic) Alkali metal alkyl borohydride.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to organoborane compounds, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 300 ppb of the PMN substance in surface waters.
Since significant environmental exposure is not expected, as the
substance is not released to surface waters as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
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
study (OPPTS 850.1075 test guideline (public draft)), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline (public draft)), and an
algal toxicity study (OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance. The fish and daphnid tests should be conducted with flow-
through methods and measured concentration. The algal test should be
conducted with static methods and measured concentration. Dilution
water hardness < 180 mg/L as CaC03.
CFR citation: 40 CFR 721.1878.
PMN Number P-00-1132
Chemical name: (generic) Siloxanes and silicones, aminoalkyl,
fluorooctyl, hydroxy-terminated salt.
CAS number: Not available.
Basis for action: The PMN substance will be used in anti-graffiti
systems as described in the PMN. Based on structural analogy to
perfluoro alkyl polycationic polymers, EPA has identified health
concerns for lung toxicity from inhalation exposure. Since
[[Page 15076]]
significant worker exposure is unlikely when used as described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may cause significant adverse
effects. EPA has determined, however, that use of the PMN substance
other than as described in the PMN could result in exposures which may
cause serious health effects. In addition, EPA has identified health
concerns for potential incineration products for the PMN substance
based on analogy to perfluorinated octane sulfonate (PFOS) and
perfluorinated octanoic acid (PFOA). These incineration products are
PBT. 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 rats with a 60-day holding period (OPPTS 870.3465
test guideline) would help characterize the human health effects of the
PMN substance. Special attention should be given to histopathology
(inflammation and cell proliferation) of the lung tissues and to
various parameters of the bronchoalveolar lavage fluid (BALF), e.g.,
marker enzyme activities, total protein content, total cell count, cell
differential, and cell viability. It is not necessary to look at
internal organs. The Agency has also determined that the following
tests would help characterize fate and ecotoxicity of the PMN
substance: A Decomposition Kinetics by Thermogravimeter (ASTM E1641), a
Compositional Analysis by Thermogravimeter (ASTM E1131), and a
Laboratory ``Burn'' test - protocol to be agreed upon by EPA and the
Company. The purpose of this test is to determine the disposition of
the material and to identify degradates, especially the presence of
components that can lead to the formation of perfluofo alkyl carboxylic
acid after burning or incineration.
CFR citation: 40 CFR 721.9502.
PMN Number P-00-1195
Chemical name: Xanthylium, 9-(2-(ethoxycarbonyl)phenyl)-3,6-
bis(ethylamino)-2,7- dimethyl-, ethyl sulfate.
CAS number: 26694-69-9.
Basis for action: The PMN substance will be used as a dye for complex
basic dye pigment manufacture. Based on submitted test data for an
analog, EPA has identified health concerns for toxic effects to the
liver and heart. Since significant worker exposure is unlikely when
used as described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that domestic
manufacture or use of the PMN substance other than as an intermediate
could result in serious health effects. Also, based on structural
analogy to cationic dyes, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 2 ppb of the PMN
substance in surface waters. Since significant environmental exposure
is not expected when the PMN substance is used as described in the PMN,
EPA has not determined that the proposed use of the substance may
present an unreasonable risk. EPA has determined, however, that use of
the substance other than as described in the PMN may cause significant
adverse environmental effects. 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 an acute oral toxicity
study (40 CFR part 799.9110(d)(1)(i)(A)), a Salmonella typhimurium
reverse mutation assay (OPPTS 870.5100 test guideline), a 28-day oral
toxicity study Organization for Economic Cooperation and Development
(OECD) guideline no. 407 or OPPTS 870.3050 test guideline), and an in
vivo mammalian cytogenetics test by the intraperitoneal (i.p.) route:
micronucleus assay (OPPTS 870.5395 test guideline) would help to
characterize the human health effects of the PMN substance. EPA has
also determined that a fish acute toxicity study (OPPTS 850.1075 test
guideline (public draft)), a daphnid acute toxicity study (OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (OPPTS 850.5400 test guideline (public draft)) would help to
characterize the environmental effects of the PMN substance. The fish
and daphnid tests should be conducted with flow-through methods and
measured concentration. The algal test should be conducted with static
methods and measured concentration. Dilution water hardness < 180 mg/L
as CaC03.
CFR citation: 40 CFR 721.2465.
PMN Number P-01-0432
Chemical name: (generic) Bis heterocyclic phenylene derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as a reactive modifier
for polymeric substances. EPA has identified health concerns for
neurotoxicity, developmental toxicity, mutagenicity, carcinogenicity,
lung and liver toxicity, and sensitization based on test data. Since
significant worker exposure is unlikely because there would not be
significant inhalation exposure for the use identified in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the substance as described in the PMN present an unreasonable risk.
EPA has determined, however, that an increase in production volume over
that described in the PMN could result in significant exposure to human
health. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii) and (b)(1)(i)(A).
Recommended testing: EPA has determined that a mouse micronucleus test
by the i.p. route (OPPTS 870.5395 test guideline) and a 28-day oral
toxicity in rats OECD guideline number 407 or (OPPTS 870.3050) with a
Functional Observational Battery (FOB) would help to characterize the
health effects of the substance. If the above tests indicate a health
concern, then the following tests may be necessary to qualify the
potential health effects: a 90-day subchronic oral study in rats (OPPT
870.3100 test guideline), a prenatal development toxicity study by oral
route in two species (OPPTS 870.3700 test guideline), a reproduction
and fertility effects (OPPTS 870.3800 test guideline), and a
carcinogenicity study (OPPTS 870.4200 test guideline).
CFR citation: 40 CFR 721.5925.
IV. Objectives and Rationale of the Rule
During review of the PMNs submitted for the chemical substances
that are subject to this SNUR, EPA concluded that for 3 of the 62
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 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 substances designated herein are
consistent with the provisions of the TSCA section 5(e) consent orders.
In the other 59 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.
EPA is issuing this SNUR for specific chemical substances which
have undergone premanufacture review to ensure that:
1. EPA will receive notice of any company's intent to manufacture,
import, or process a listed chemical
[[Page 15077]]
substance for a significant new use before that activity begins.
2. EPA will have an opportunity to review and evaluate data
submitted in a SNUR notice before the notice submitter begins
manufacturing, importing, or processing a listed chemical substance for
a significant new use.
3. When necessary, to prevent unreasonable risks, EPA will be able
to regulate prospective manufacturers, importers, or processors of a
listed chemical substance before a significant new use of that
substance occurs.
4. All manufacturers, importers, and processors of the same
chemical substance which 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 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), this rule will be effective May 27, 2003, unless EPA
receives a written notice by April 28, 2003 that someone wishes to make
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 substance to which the adverse or critical comments
apply. EPA will then propose a SNUR for the specific substance
providing a 30-day comment period.
This action establishes SNURs for a number of chemical substances.
Any person who submits a notice of intent to submit adverse or critical
comments must identify the substance and the new use to which it
applies. EPA will not withdraw a SNUR for a substance not identified in
a notice.
VI. Test Data and Other Information
EPA recognizes that section 5 of TSCA 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.
In cases where a TSCA section 5(e) consent order requires or recommends
certain testing, Unit III. lists those recommended tests.
However, EPA has established production limits in the TSCA section
5(e) consent orders for several of the substances regulated under this
rule, 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 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 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.
The recommended studies may not be the only means of addressing the
potential risks of the 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:
1. Human exposure and environmental release that may result from
the significant new use of the chemical substances.
2. Potential benefits of the substances.
3. Information on risks posed by the substances compared to risks
posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule some 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 substance subject to a SNUR is CBI.
This procedure is cross-referenced in each of these SNURs.
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 incorporated from Sec. 721.1725(b)(1), a manufacturer or
importer must show that it has a bona fide intent to manufacture or
import the substance and must identify the specific use for which it
intends to manufacture or import the substance. If EPA concludes that
the person has shown a bona fide intent to manufacture or import the
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 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 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
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 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 3 substances and notice submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received an NOC and the substance has not been
[[Page 15078]]
added to the Inventory, no other person may commence such activities
without first submitting a PMN. For 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 Inventory prior to the
effective date of the rule, the 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, 41
of the 62 substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions, the Agency believes that it is highly unlikely
that any of the significant new uses described in the following
regulatory text are ongoing.
As discussed in the Federal Register of April 24, 1990, 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 rather than as of the effective date of the rule. Thus,
persons who begin commercial manufacture, import, or processing of the
substances regulated through this SNUR will have to cease any such
activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of the substance between publication and the effective date
of the SNUR do not meet the conditions of advance compliance, they must
cease that activity before the effective date of the rule. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substance subject to this rule. EPA's complete economic
analysis is available in the official public docket.
X. Statutory and Executive Order Reviews
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that proposed or final SNURs are not a
``significant regulatory action'' subject to review by OMB, because
they do not meet the criteria in section 3(f) of the Executive Order.
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.
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 900 SNURs, the
Agency has received fewer than 25 SNUNs. 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.),
are minimal regardless of the size of the firm. Therefore, EPA believes
that the potential economic impact of complying with this SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published on June 2, 1997 (62 FR 29684)
(FRL-5597-1), the Agency presented 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.
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or tribal government will be impacted by this rulemaking.
As such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).
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).
This rule does not have tribal implications because it is not
expected to have substantial direct effects on
[[Page 15079]]
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.
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.
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.
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.
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).
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.
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).
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a final rule may take effect, the Agency
promulgating it must submit a final rule report, which includes a copy
of the final rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
final rule and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the final rule in the Federal Register.
This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: March 17, 2003.
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. 721.321 to subpart E to read as follows:
Sec. 721.321 Substituted acrylamides and acrylic acid copolymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted acrylamides and acrylic acid copolymer (PMN P-00-0490) is
subject to reporting under this section for the significant new use
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)(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.
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3. By adding new Sec. 721.338 to subpart E to read as follows:
Sec. 721.338 Salt of an acrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as salt
of an acrylate copolymer (PMNs P-00-0333 and P-00-0334) are subject to
reporting under this section for the significant new use 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)(2), (w)(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.
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4. By adding new Sec. 721.463 to subpart E to read as follows:
Sec. 721.463 Acrylate of polymer based on isophorone diisocyanate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
acrylate of polymer based on isophorone diisocyanate (PMN P-00-0626) is
subject to reporting under this section for the significant new use
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), (c)(4) (N=3 ppb).
(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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5. By adding new Sec. 721.465 to subpart E to read as follows:
Sec. 721.465 Alkoxylated alkylpolyol acrylates, adduct with
alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 15080]]
(1) The chemical substances identified generically as alkoxylated
alkylpolyol acrylates, adduct with alkylamine (PMNs P-98-0082, P-98-
0083, and P-98-0084 are subject to reporting under this section for the
significant new use 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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6. By adding new Sec. 721.522 to subpart E to read as follows:
Sec. 721.522 Oxirane, methyl-, polymer with oxirane, mono(3,5,5,-
trimethylhexyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, methyl-,
polymer with oxirane, mono(3,5,5,-trimethylhexyl) ether (PMN P-99-0669;
CAS No. 204336-40-3) is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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7. By adding new Sec. 721.525 to subpart E to read as follows:
Sec. 721.525 1-propanol, 3-propoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanol, 3-
propoxy- (PMN P-00-0827; CAS No. 4161-22-2) is subject to reporting
under this section for the significant new use 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)(2)(i) and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o) and (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), 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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8. By adding new Sec. 721.532 to subpart E to read as follows:
Sec. 721.532 Substituted hydroxyalkane acetate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted hydroxyalkane acetate (PMN P-00-0618) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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9. By adding new Sec. 721.533 to subpart E to read as follows:
Sec. 721.533 Propane, 1,1,1,3,3-pentachloro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propane, 1,1,1,3,3-
pentachloro- (PMN P-99-1327; CAS No. 23153-23-3) is subject to
reporting under this section for the significant new use 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.
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10. By adding new Sec. 721.638 to subpart E to read as follows:
Sec. 721.638 Silyl amine, potassium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as silyl
amine, potassium salt (PMN P-00-1086) is subject to reporting under
this section for the significant new use 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) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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11. By adding new Sec. 721.648 to subpart E to read as follows:
Sec. 721.648 Alkyl dialkylamino phenylsulfonyl alkenoate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
dialkylamino phenylsulfonyl alkenoate (PMN P-00-0816) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
[[Page 15081]]
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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12. By adding new Sec. 721.843 to subpart E to read as follows:
Sec. 721.843 Substituted phenylazophenylazo phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted phenylazophenylazo, phenol (PMN P-00-0420) is subject to
reporting under this section for the significant new use 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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13. By adding new Sec. 721.910 to subpart E to read as follows:
Sec. 721.910 Propanetriol polyalkylenepolyolamine aryl aldimine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanetriol polyalkylenepolyolamine aryl aldimine (PMN P-99-0873) is
subject to reporting under this section for the significant new use
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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14. By adding new Sec. 721.984 to subpart E to read as follows:
Sec. 721.984 Amino-hydroxy sulfonaphthylazo-disubstituted phenyl azo
benzene carboxylate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amino-
hydroxy sulfonaphthylazo-disubstituted phenyl azo benzene carboxylate
salt (PMN P-00-0351) is subject to reporting under this section for the
significant new use 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)(2), (w)(2), (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.
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15. By adding new Sec. 721.990 to subpart E to read as follows:
Sec. 721.990 1,4-Benzedicarboxylic acid, dimethyl ester, polymer with
1,4 - butanediol, cyclized.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzedicarboxylic acid, dimethyl ester, polymer with 1,4 - butanediol,
cyclized (PMN P-00-0789; CAS No. 263244-54-8) is subject to reporting
under this section for the significant new use 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. 721.1767 to subpart E to read as follows:
Sec. 721.1767 Substituted 6,6'-(1-methylethylidene)bis[3,4-dihydro-3-
phenyl-1,3-benzoxazine] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted 6,6'-(1-methylethylidene)bis[3,4-dihydro-3-phenyl-1,3-
benzoxazine] (PMN P-00-0993) 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. 721.1852 to subpart E to read as follows:
Sec. 721.1852 Di-alkyl borane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as di-
alkyl borane (PMN P-00-1087) is subject to reporting under this section
for the significant new use 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=200 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
[[Page 15082]]
(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.
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18. By adding new Sec. 721.1878 to subpart E to read as follows:
Sec. 721.1878 Alkali metal alkyl borohydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkali
metal alkyl borohydride (PMN P-00-1089) is subject to reporting under
this section for the significant new use 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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19. By adding new Sec. 721.1880 to subpart E to read as follows:
Sec. 721.1880 Borate(1-), tris(acetato-.kappa.O)hydro-, sodium, (T-
4)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as borate(1-),
tris(acetato-.kappa.O)hydro-, sodium, (T-4)- (PMN P-00-0922; CAS No.
56553-60-7) is subject to reporting under this section for the
significant new use 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=300 ppb).
(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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20. By adding new Sec. 721.2093 to subpart E to read as follows:
Sec. 721.2093 Alkenyl carboxylate, metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkenyl
carboxylate, metal salt (PMN P-99-0848) is subject to reporting under
this section for the significant new use 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) (an emulsifier for metalworking fluids)
and (q).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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21. By adding new Sec. 721.2155 to subpart E to read as follows:
Sec. 721.2155 Alkoxyamino-alkyl-coumarin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkoxyamino-alkyl-coumarin. (PMN P-00-0108) is subject to reporting
under this section for the significant new use 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.
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22. By adding new Sec. 721.2465 to subpart E to read as follows:
Sec. 721.2465 Xanthylium, 9-(2-(ethoxycarbonyl)phenyl)-3,6-
bis(ethylamino)-2,7-dimethyl-, ethyl sulfate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as xanthylium, 9-(2-
(ethoxycarbonyl)phenyl)-3,6-bis(ethylamino)-2,7-dimethyl-, ethyl
sulfate (PMN P-00-1195; CAS No. 26694-69-9) is subject to reporting
under this section for the significant new use 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) and (j) (a basic dye for complex basic
dye pigment manufacture).
(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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23. By adding new Sec. 721.2577 to subpart E to read as follows:
Sec. 721.2577 Copper complex of (substituted sulfonaphthyl azo
substituted phenyl) disulfonaphthyl azo, amine salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as copper
complex of (substituted sulfonaphthyl azo substituted phenyl)
disulfonaphthyl azo, amine salt (PMNs P-00-0364 and P-00-0365) are
subject to reporting under this section for the significant new use
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), (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.
[[Page 15083]]
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24. By adding new Sec. 721.2582 to subpart E to read as follows:
Sec. 721.2582 Reaction product of alkylene diamine, MDl, substituted
carbomonocyclic amine and alkylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of alkylene diamine, MDl, substituted carbomonocyclic
amine and alkylamine (PMN P-98-1262) is subject to reporting under this
section for the significant new use 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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25. By adding new Sec. 721.2584 to subpart E to read as follows:
Sec. 721.2584 Dodecanoic acid, 12-amino-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as dodecanoic acid,
12-amino- (PMN P-98-0823; CAS No. 693-57-2) 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) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi),
(a)(5)(vii), (a)(6)(i), (b) (concentration set at 0.1 percent), and
(g). As an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the NCEL
provision listed in the 5(e) consent order for this substance. The NCEL
is 1.0 mg/m\3\ as an 8-hour time-weighted average verified by actual
monitoring data.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(ii), (g)(1)(vii),
(g)(2)(ii), and (g)(2)(iv).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (r) (6,000,000 kg.), and a
carcinogenicity study (OPPTS 870.4200). A person may not manufacture or
import the substance beyond the aggregate production volume limit,
unless that person conducts this study on the substance and submits all
final reports and underlying data in accordance with the procedures and
criteria specified in paragraphs (a)(2)(iii)(A), (a)(2)(iii)(B),
(a)(2)(iii)(C), and (a)(2)(iii)(D) of this section.
(A) Each study required to be performed pursuant to this section
must be scientifically valid. Scientifically valid means that the study
was conducted according to:
(1) The test guidelines specified in paragraph (a)(2)(iii) of this
section.
(2) An EPA-approved protocol.
(3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.
(4) Using methodologies generally accepted at the time the study is
initiated.
(5) Any deviation from these requirements must be approved in
writing by EPA.
(B) Before starting to conduct any of the studies in paragraph
(a)(2)(iii) of this section, the person must obtain approval of test
protocols from EPA by submitting written protocols. EPA will respond to
the person within 4 weeks of receiving the written protocols. Published
test guidelines specified in paragraph (a)(2)(iii) of this section
(e.g., 40 CFR part 797 or part 798) provide general guidance for
development of test protocols, but are not themselves acceptable
protocols.
(C) The person shall:
(1) Conduct each study in good faith with due care.
(2) Promptly furnish to EPA the results of any interim phase of
each study.
(3) Submit, in triplicate (with an additional sanitized copy, if
confidential business information is involved), the final report of
each study and all underlying data (``the report and data'') to EPA no
later than 14 weeks prior to exceeding the applicable production volume
limit. The final report shall contain the contents specified in 40 CFR
792.185.
(D)(1) Except as described in paragraph (a)(2)(iii)(D)(2) of this
section, if, within 6 weeks of EPA's receipt of a test report and data,
the person receives written notice that EPA finds that the data
generated by a study are scientifically invalid, the person is
prohibited from further manufacture and import of the PMN substance
beyond the applicable production volume limit.
(2) The person may continue to manufacture and import the PMN
substance beyond the applicable production limit only if so notified,
in writing, by EPA in response to the person's compliance with either
of the following paragraphs (a)(2)(iii)(D)(2)(i) or
(a)(2)(iii)(D)(2)(ii) of this section.
(i) The person may reconduct the study. If there is sufficient time
to reconduct the study and submit the report and data to EPA at least
14 weeks before exceeding the production limit as required by paragraph
(a)(2)(iii)(C)(3) of this section, the person shall comply with
paragraph (a)(2)(iii)(C)(3) of this section. If there is insufficient
time for the person to comply with paragraph (a)(2)(iii)(C)(3) of this
section, the person may exceed the production limit and shall submit
the report and data in triplicate to EPA within a reasonable period of
time, all as specified by EPA in the notice described in paragraph
(a)(2)(iii)(D)(1) of this section. EPA will respond to the person in
writing, within 6 weeks of receiving the person's report and data.
(ii) The person may, within 4 weeks of receiving from EPA the
notice described in paragraph (a)(2)(iii)(D)(1) of this section, submit
to EPA a written report refuting EPA's finding. EPA will respond to the
person in writing, within 4 weeks of receiving the person's report.
(E) The person is not required to conduct a study specified in
paragraph (a)(2)(iii) of this section if notified in writing by EPA
that it is unnecessary to conduct that study.
(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), 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
26. By adding new Sec. 721.2673 to subpart E to read as follows:
Sec. 721.2673 Aromatic epoxide resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic epoxide resin (PMN P-99-1399) is subject to reporting under
this section for the significant new use 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(y)(1).
(ii) [Reserved]
[[Page 15084]]
(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. 721.3805 to subpart E to read as follows:
Sec. 721.3805 Formaldehyde, reaction products with 1,3-
benzenedimethanamine and bisphenol A.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
reaction products with 1,3-benzenedimethanamine and bisphenol A (PMN P-
00-0738; CAS No. 259871-68-6) is subject to reporting under this
section for the significant new use 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
28. By adding new Sec. 721.3807 to subpart E to read as follows:
Sec. 721.3807 Formaldehyde, polymer with phenol and 1,2,3-
propanetriol, methylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with phenol and 1,2,3-propanetriol, methylated (PMN P-99-0044;
CAS No. 209810-57-1) is subject to reporting under this section for the
significant new use 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=3 ppb).
(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
29. By adding new Sec. 721.3812 to subpart E to read as follows:
Sec. 721.3812 Substituted phenols and formaldehyde polymer, alkylated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted phenols and formaldehyde polymer, alkylated (PMN P-00-0542)
is subject to reporting under this section for the significant new use
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) (a resin for can and tube coatings).
(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
30. By adding new Sec. 721.3818 to subpart E to read as follows:
Sec. 721.3818 Furan, octafluorotetrahydro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as furan,
octafluorotetrahydro- (PMN P-99-0965; CAS No. 773-14-8) is subject to
reporting under this section for the significant new use 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) (a heat transfer agent).
(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. 721.3848 to subpart E to read as follows:
Sec. 721.3848 Glycine, N-(carboxymethyl)-N-dodecyl-, monosodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycine, N-
(carboxymethyl)-N-dodecyl-, monosodium salt (PMN P-00-469; CAS No.
141321-68-8) is subject to reporting under this section for the
significant new use 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), (c)(4) (N=30 ppb).
(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
32. By adding new Sec. 721.4136 to subpart E to read as follows:
Sec. 721.4136 Alkyl heteropolycyclic-aniline (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
heteropolycyclic-aniline (PMN P-00-0067) is subject to reporting under
this section for the significant new use 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=1 ppb).
(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
33. By adding new Sec. 721.4486 to subpart E to read as follows:
[[Page 15085]]
Sec. 721.4486 Propanoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-
trimethylbicyclo[2.2.1]hept-2-yl ester, rel-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as propanoic acid, 2-
methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel-
(PMNs P-98-0497 and P-98-0509; CAS No. 85586-67-0) are subject to
reporting under this section for the significant new use 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(p) (15,000 kg/yr).
(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
34. By adding new Sec. 721.4575 to subpart E to read as follows:
Sec. 721.4575 L-aspartic acid, N,N'- [(1E) - 1,2 - ethenediylbis[(3-
sulfo-4, 1-phenylene)imino [6-(phenylamino)-1,3,5-triazine- 4,2-
diyl]]]bis-, hexasodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as l-aspartic acid,
N,N'- [(1E) - 1,2 - ethenediylbis[(3-sulfo-4, 1-phenylene) imino[6-
(phenylamino)-1,3,5-triazine-4,2-diyl]]]bis-, hexasodium salt (PMN P-
99-1167; CAS No. 205764-98-3) is subject to reporting under this
section for the significant new use 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), (x)(1), and (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
35. By adding new Sec. 721.4792 to subpart E to read as follows:
Sec. 721.4792 2-propenoic acid, 2-methyl-, C11-14-isoalkyl
esters, C13-rich.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, C11-14-isoalkyl esters, C13-rich (PMN
P-99-1189; CAS No. 85736-97-6) is subject to reporting under this
section for the significant new use 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) (a monomer for casting automotive parts
adhesives or impregnation fluid).
(ii) Release to water. Requirements as specified in Sec.
721.90(c)(4) (N=1 ppb).
(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
36. By adding new Sec. 721.5260 to subpart E to read as follows:
Sec. 721.5260 1,3,6-Naphthalenetrisulfonic acid, 7-[[2-
[(aminocarbonyl)amino]-4-[[4-[[2-[2-
(ethenylsulfonyl)ethoxy]ethyl]amino]-6-fluoro-1,3,5-triazin-2-
yl]amino]phenyl]azo], trisodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3,6-
Naphthalenetrisulfonic acid, 7-[[2-[(aminocarbonyl)amino]-4-[[4-[[2-[2-
(ethenylsulfonyl)ethoxy]ethyl]amino]-6-fluoro-1,3,5-triazin-2-
yl]amino]phenyl]azo], trisodium salt (PMN P-00-0806; CAS No. 106359-91-
5) is subject to reporting under this section for the significant new
use 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
37. By adding new Sec. 721.5262 to subpart E to read as follows:
Sec. 721.5262 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-
[substituted] amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulfo-2-
naphthalenyl)azo]-, trisodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,7-
Naphthalenedisulfonic acid, 5-[[4-chloro-6-[substituted] amino]-1,3,5-
triazin-2-yl]amino]-4-hydroxy-3-[(1-sulfo-2-naphthalenyl)azo]-,
trisodium salt (PMN P-00-0803) is subject to reporting under this
section for the significant new use 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
38. By adding new Sec. 721.5283 to subpart E to read as follows:
Sec. 721.5283 Cobaltate (5-), bis[4-[[6-[(4-amino-6-chloro-1,3,5-
triazin-2-yl)amio]-1-hydroxy-3-sulfo-2-naphthalenyl]azo]-3-hydroxy-7-
nitro-1-naphthalenesulfonato(4-)]-, pentasodium.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cobaltate (5-),
bis[4-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amio]-1-hydroxy-3-
sulfo-2-naphthalenyl]azo]-3-hydroxy-7-nitro-1-naphthalenesulfonato(4-
)]-, pentasodium (PMN P-99-0990; CAS No. 91144-26-2) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5)(ii), (a)(5)(xii), and (a)(5)(xiii).
(ii) Industrial, commercial, and consumer activities. Requirements
as
[[Page 15086]]
specified in Sec. 721.80(j) (a spray applied automotive coating).
(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), 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
39. By adding new Sec. 721.5286 to subpart E to read as follows:
Sec. 721.5286 Benzenediazonium,
[[[[(substituted)azo]phenyl]sulfonyl]amino]-, coupled with aminophenol,
diazotized aminobenzoic acid, diazotized (substituted) benzenesulfonic
acid and naphthalenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenediazonium, [[[[(substituted) azo]phenyl]sulfonyl]amino]-,
coupled with aminophenol, diazotized aminobenzoic acid, diazotized
(substituted) benzenesulfonic acid and naphthalenol (PMN P-00-0045) is
subject to reporting under this section for the significant new use
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
40. By adding new Sec. 721.5452 to subpart E to read as follows:
Sec. 721.5452 Alkali metal salt of halogenated organoborate
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkali
metal salt of halogenated organoborate (PMN P-00-0638) is subject to
reporting under this section for the significant new use 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
41. By adding new Sec. 721.5454 to subpart E to read as follows:
Sec. 721.5454 Methylium, tripohenyl-, tetrakis(pentafluorophenyl)
borate (1-).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as methylium,
tripohenyl-, tetrakis(pentafluorophenyl) borate (1-) (PMN P-00-0637;
CAS No. 136040-19-2) is subject to reporting under this section for the
significant new use 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
42. By adding new Sec. 721.5590 to subpart E to read as follows:
Sec. 721.5590 Oxirane, [[[(1R,2S,5R)-5-methyl-2-(1-
methylethyl)cyclohexyl]oxy]methyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane,
[[[(1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl]oxy]methyl]- (PMN P-
00-0330; CAS No. 249297-16-3) is subject to reporting under this
section for the significant new use 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) 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 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
43. By adding new Sec. 721.5925 to subpart E to read as follows:
Sec. 721.5925 Bis heterocyclic phenylene derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as bis
heterocyclic phenylene derivative (PMN P-01-0432) is subject to
reporting under this section for the significant new use 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(p) (20,000 kg/yr).
(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
44. By adding new Sec. 721.6005 to subpart E to read as follows:
Sec. 721.6005 Rare earth phosphate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as rare
earth phophate (PMNs P-99-1191 and P-99-1192) are subject to reporting
under this section for the significant new use 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=10).
(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
[[Page 15087]]
(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
45. By adding new Sec. 721.6178 to subpart E to read as follows:
Sec. 721.6178 Alkylaminated polyolefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylaminated polyolefin (PMN P-99-1287) is subject to reporting under
this section for the significant new use 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
46. By adding new Sec. 721.6181 to subpart E to read as follows:
Sec. 721.6181 Fatty acid, reaction product with substituted oxirane,
formaldehyde-phenol polymer glycidyl ether, substituted proplyamine and
polyethylenepolyamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid, reaction product with substituted oxirane, formaldehyde-phenol
polymer glycidyl ether, substituted proplyamine and
polyethylenepolyamines (PMN P-98-1125) is subject to reporting under
this section for the significant new use 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=10ppb).
(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. 721.6183 to subpart E to read as follows:
Sec. 721.6183 Amides, from ammonium hydroxide - maleic anhydride
polymer and hydrogenated tallow alkyl amines, sodium salts, compds.
with ethanolamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, from
ammonium hydroxide - maleic anhydride polymer and hydrogenated tallow
alkyl amines, sodium salts, compds. with ethanolamine (PMN P-00-0691;
CAS No. 208408-03-1) is subject to reporting under this section for the
significant new use 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=80 ppb).
(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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48. By adding new Sec. 721.6205 to subpart E to read as follows:
Sec. 721.6205 Hexamethylenediamine adduct of substituted
piperidinyloxy (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
hexamethylenediamine adduct of substituted piperidinyloxy (PMN P-99-
0510) is subject to reporting under this section for the significant
new use 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)(i), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii),
(a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(5)(vii),
(a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(5)(xii),
(a)(5)(xiii) (a)(5)(xiv), (a)(5)(xv), (a)(6)(i), (a)(6)(ii),
(a)(6)(iii), (a)(6)(iv), (a)(6)(v), and (a)(6)(vi), (b) (concentration
set at 1.0 percent), and (c). The imperviousness of each item pursuant
to paragraph (a)(2)(i) must be demonstrated by actual testing under
paragraph (a)(3) and not by manufacturer specifications. Permeation
testing shall be conducted according to the American Society for
Testing and Materials (ASTM) F739 ``Standard Test Method for Resistance
of Protective Clothing Materials to Permeation by Liquids or Gases'' or
its equivalent. Results shall be recorded as a cumulative permeation
rate as a function of time, and shall be documented in accordance with
ASTM F739 using the format specified in ASTM 1194-89 ``Guide for
Documenting the Results of Chemical Permeation Testing on Protective
Clothing Materials'' or its equivalent. Gloves may not be used for a
time period longer than they are actually tested and must be replaced
at the end of each work shift. The manufacturer, importer, or processor
must submit all test data to the Agency and must receive written Agency
approval for each type of glove tested prior to use of such gloves. The
following gloves have been tested in accordance with the ASTM F739
method and found to satisfy the requirements for use by EPA: Latex (at
least 14 mils thick), Nitrile (at least 16 mils thick), and
Silvershield (at least 3 mils thick). As an alternative to the
respiratory requirements listed here, a manufacturer, importer, or
processor may choose to follow the NCEL provisions listed in the TSCA
section 5(e) consent order for this substance. The NCEL is 0.2 ug/m\3\
as an 8-hour time weighted average verified by actual monitoring data.
(ii) 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)(iv), (g)(1)(vi),
(g)(1)(viii), (g)(2)(i), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), 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), (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.
[[Page 15088]]
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49. By adding new Sec. 721.8085 to subpart E to read as follows:
Sec. 721.8085 Reaction product of substituted aromatic diol,
formaldehyde and alkanolamine, propoxylated (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of substituted aromatic diol, formaldehyde and
alkanolamine, propoxylated (PMN P-00-0202) is subject to reporting
under this section for the significant new use 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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50. By adding new Sec. 721.8658 to subpart E to read as follows:
Sec. 721.8658 Modified polymer of vinyl acetate and quaternary
ammonium compound (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified polymer of vinyl acetate and quaternary ammonium compound (PMN
P-99-0874) is subject to reporting under this section for the
significant new use 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
51. By adding new Sec. 721.8920 to subpart E to read as follows:
Sec. 721.8920 4,6-Disubstituted pyrimidine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 4,6-
disubstituted pyrimidine (PMN P-99-1366) is subject to reporting under
this section for the significant new use 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.
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52. By adding new Sec. 721.9502 to subpart E to read as follows:
Sec. 721.9502 Siloxanes and silicones, aminoalkyl, fluorooctyl,
hydroxy-terminated salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy-terminated
salt (PMN P-00-1132) is subject to reporting under this section for the
significant new use 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) (graffiti systems) and (y)(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.
(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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53. By adding new Sec. 721.9504 to subpart E to read as follows:
Sec. 721.9504 Silane, triethoxy (3,3,4,4,5,5, 6,6,7,7,8,8,8-
tridecafluorooctyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silane, triethoxy
(3,3,4,4,5, 5,6,6,7,7,8,8,8-tridecafluorooctyl)- (PMN P-99-1346; CAS
No. 51851-37-7) is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5)(ii),( (a)(5)(xii), and (a)(5)(xiii).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o).
(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), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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54. By adding new Sec. 721.9520 to subpart E to read as follows:
Sec. 721.9520 Methylated-para-rosaniline salt of a trisulfonated
triarylmethane dye (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
methylated-para-rosaniline salt of a trisulfonated triarylmethane dye
(PMN P-00-0559) is subject to reporting under this section for the
significant new use 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 in Sec. 721.90
(a)(4), (b)(4), (c)(4) (N=2 ppb).
(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.
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55. By adding new Sec. 721.9538 to subpart E to read as follows:
[[Page 15089]]
Sec. 721.9538 Lithium salt of sulfophenyl azo phenyl azo
disulfostilbene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
salt of sulfophenyl azo phenyl azo disulfostilbene (PMN P-00-0698) is
subject to reporting under this section for the significant new use
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)(2), (w)(2), (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.
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56. By adding new Sec. 721.9597 to subpart E to read as follows:
Sec. 721.9597 Salt of a substituted sulfonated aryl azo compound
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as salt of
a substituted sulfonated aryl azo compound (PMN P-00-0094) is subject
to reporting under this section for the significant new use 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.
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57. By adding new Sec. 721.9952 to subpart E to read as follows:
Sec. 721.9952 Alkoxylated aliphatic diisocyanate allyl ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkoxylated aliphatic diisocyanate allyl ether (PMN P-00-0353) is
subject to reporting under this section for the significant new use
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.
[FR Doc. 03-7373 Filed 3-27-03; 8:45 am]
BILLING CODE 6560-50-S