Significant New Uses of Certain Chemical Substances
[Federal Register: December 17, 2003 (Volume 68, Number 242)]
[Rules and Regulations]
[Page 70155-70184]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de03-16]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPT-2002-0078; FRL-7307-3]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: EPA is promulgating significant new use rules (SNURs) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 65
chemical substances which were the subject of premanufacture notices
(PMNs) and subject to TSCA section 5(e) consent orders issued by EPA.
This action requires persons who intend to manufacture, import, or
process these chemical substances for a significant new use to notify
EPA at least 90 days before commencing the manufacturing or processing
of the chemical substance for a use designated by this rule as a
significant new use. The required notification will provide EPA with
the opportunity to evaluate the intended
[[Page 70156]]
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.
DATES: The effective date of this rule is February 17, 2004, without
further notice, unless EPA receives adverse or critical comments, or
notice of intent to submit adverse or critical comments before January
16, 2004. This rule shall be promulgated for purposes of judicial
review at 1 p.m. (e.s.t.) on December 31, 2003.
If EPA receives adverse or critical comments or notice of intent to
submit adverse or critical comments before January 16, 2004, 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 chemical substance for which the adverse or
critical comment or notice of intent to submit adverse or critical
comment is received and will issue a proposed SNUR providing a 30-day
period for public comment.
ADDRESSES: Adverse or critical 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, 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 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-2002-0078. 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/.
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_40/40cfr721_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,
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
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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-20027-0078. 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-2002-0078. 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 Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2002-0078. 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 in this
document, 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.
II. Background
A. What Action is the Agency Taking?
EPA is promulgating this SNUR using direct final procedures. This
SNUR will require persons to notify EPA at least 90 days before
commencing manufacturing, importing, or processing a chemical 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.
[[Page 70158]]
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a "significant new
use." EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a notice to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. The mechanism for reporting under this
requirement is established under 40 CFR 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear under 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
TSCA section 5(a)(1)(A). In particular, these requirements include the
information submission requirements of TSCA section 5(b) and 5(d)(1),
the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
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 chemical substance identified in a
proposed or final SNUR are subject to the export notification
provisions of TSCA section 12(b). The regulations that interpret TSCA
section 12(b) appear at 40 CFR part 707. Persons who intend to import a
chemical substance identified in a final SNUR are subject to the TSCA
section 13 import certification requirements, which appear 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
chemical 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 chemical 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 chemical substance, the tests are described in this unit.
As explained further in Unit VI., the SNUR for such chemical 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 chemical 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 chemical substances,
testing other than that specified in the TSCA section 5(e) consent
order for the chemical substances, or studies on analogous chemical
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 99-255, 99-314, 99-350/351/
352/353, 99-534,99-848, 00-277/278/280, 00-281-285, 00-286-292, 00-502/
503/504, 00-574/575/576/577/608,00-901, 00-1085, 00-1093, 01-558, 01-
584, 01-629, 01-728, 01-757, 01-776, 02-16, 02-195, 02-415, 02-536, 02-
609, and 02-700, which are subject to a final TSCA section 5(e) consent
order. The TSCA section 5(e) consent orders for these chemical
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 chemical
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 chemical substances which are subject to a final
section 5(e) consent order under TSCA.
PMN Number P-97-1108
Chemical name: (generic) Polycarboxylic acid ester.
CAS number: Not available.
Basis for action: The PMN substance will be used as a plasticizer.
Based on structural analogy to esters, EPA is concerned that toxicity
to aquatic organisms may occur at a concentration as low as 1 part per
billion (ppb) of the PMN substance in surface waters. Since
[[Page 70159]]
environmental releases are not expected as described in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the PMN substance may present an unreasonable risk. EPA has
determined, however, that release of the PMN substance to surface
waters may cause significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish chronic toxicity
study (OPPTS 850.1400 test guideline), a daphnid chronic toxicity study
(OPPTS 850.1300 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. A porous pot study (OPPTS 835.3220 test
guideline) would help to characterize possible environmental effects of
the PMN substance as well.
CFR citation: 40 CFR 721.3110.
PMN Number P-98-848
Chemical name: Silicic acid
(H6SiO2O7), magnesium strontium
salt(1:1:2), dysprosium and europium-doped.
CAS number: 181828-07-9.
Effective date of section 5(e) consent order: June 1, 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 the PMN substance may present an unreasonable risk to
human health.
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study (OPPTS 870.3465 test guideline) and a 2-year bioassay
(OPPTS 870.4200) would help to characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.9511.
PMN Number P-98-1033/1034/1035
Chemical name: (generic) Halogen substituted oxetanes.
CAS number: Not available.
Effective date of section 5(e) consent order: April 6, 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)(II) of TSCA based on a
finding that these PMN substances are expected to be produced in
substantial quantities, there may be significant or substantial human
exposure to the PMN substances, and the PMN substances may enter the
environment in substantial quantities.
Recommended testing: EPA has determined that the following studies
would help to characterize the health effects of these PMN substances:
A 28-day oral toxicity study in rats (OPPTS 870.3050) that includes a
neurotoxicity functional observational battery (National Technical
Information Service (NTIS): PB 91-154617) for all test doses with the
highest dose set at 1,000 milligram/kilogram (mg/kg), and for the
highest test dose group only, histopathologic examination to include
testes/ovaries and lungs; an in vivo mouse micronucleus assay
(intraperitoneal) (OPPTS 870.5395); and an oral developmental toxicity
study in one species (OPPTS 870.3700). EPA has determined that a fish
acute toxicity study (OPPTS 850.1075), a daphnid acute toxicity study
(OPPTS 850.1010), and an algal acute toxicity study (OPPTS 850.5400)
would help to characterize the environmental effects of these PMN
substances. The PMN submitter has agreed not to exceed the production
volume limit without performing these toxicity studies using P-98-1033.
CFR citation: 40 CFR 721.5546.
PMN Number P-99-783
Chemical name: (generic) Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-
naphthenyl)azo]-7-nitro-1- substituted][N-[7-hydroxy-8-[(2-hydroxy-5-
nitrophenyl)azo]-1-substituted]-, salt.
CAS number: Not available.
Basis for action: The PMN substance will be used for the dyeing of wool
fiber. Based on structural analogy to anionic dyes, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 7 part per billion (ppb) of the PMN substance in surface waters.
Since significant environmental exposure is not expected as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that release of the PMN substance to
surface waters in significant amounts from domestic manufacture 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 daphnid acute toxicity
study (OPPTS 850.1010 test guideline), and an algal toxicity study
(OPPTS 850.5400 test guideline) would help to characterize the
environmental effects of the PMN substance. A stock solution should be
prepared and its pH adjusted to 7.0 prior to testing. The dilution
water of the daphnid acute toxicity test should have a hardness of less
than 180.0 mg/liter(L) as CaCO3 and a total organic carbon
(TOC) concentration of less than 2.0 mg TOC/L. The green algal growth
medium should also have a TOC of less than 2.0 mg TOC/L. The daphnid
test should be done with a flow-through method and measured
concentrations. The algal toxicity test should be done with the static
method and measured concentrations.
CFR citation: 40 CFR 721.5288.
PMN Number P-99-817
Chemical name: (generic) Salt of an acrylic acid - acrylamide
terpolymer
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to polyanionic polymers, EPA has
identified concerns for lung toxicity from respiratory overload if the
PMN substance is inhaled. Since significant human exposure is unlikely
when the PMN substance is used as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that use of the PMN substance as a solid may result in
significant human exposure. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the 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), bronchoalveolar 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 721.9640.
PMN Number P-99-897
Chemical name: (generic) Substituted benzothiazole-azo-substituted
benzoquinoline nickel complex.
CAS number: Not available
Basis for action: The PMN substance will be used as a material for
optical disks. Based on analogy to nickel, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 5
ppb of the PMN substance in surface waters. Since environmental
releases are not expected as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that release of the PMN substance to surface waters may cause
significant adverse environmental effects. Based on this
[[Page 70160]]
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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.5340.
PMN Number P-99-920
Chemical name: Poly(oxy-1,2-ethanediyl), alpha-(9Z)-9-
octadecenyl-.omega.-hydroxy-, phosphate, ammonium salt.
CAS number: 58857-49-1
Basis for action: The PMN substance will be used as a dispersing agent
for pigment pastes. Based on structural analogy to anionic surfactants,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 8 ppb of the PMN substance in surface waters.
Since significant environmental releases are not expected as described
in the PMN, EPA has not determined that the proposed processing, and
use of the PMN substance may present an unreasonable risk. EPA has
determined, however, that domestic manufacture may result in release of
the PMN substance to surface waters which may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. Tests for fish and daphnids should be
done with a flow through method and measured concentrations. The algal
test can be done with a static method and measured concentrations. A
stock solution of PMN substance should be prepared and adjusted to pH 7
with either HCl or NaOH.
CFR citation: 40 CFR 721.5293.
PMN Number P-99-928
Chemical name: 2-propanol, 1,1',1'-nitrilotris-, compds. with ethanol
2-[2-(C12-14-alkyloxy) ethoxy] derivs. hydrogen sulfates.
CAS number: 222975-06-6.
Basis for action: The PMN substance will be used as a surfactant in a
toilet bowl cleaner. Based on structural analogy to anionic
surfactants, EPA is concerned that toxicity to aquatic organisms from
the PMN substance may occur at a concentration of 50 ppb in surface
waters. Since significant environmental releases are not expected, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
PMN substance could result in releases to surface waters resulting in
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. Fish and daphnid tests should be done
with a flow-through method and measured concentrations. The algal test
should also be done with measured concentrations of PMN substance.
CFR citation: 40 CFR 721.5358.
PMN Number P-99-951 and P-99-952
Chemical name: (generic) Polyisobutene epoxide.
CAS number: Not available.
Basis for action: The PMN substances will be used as described in the
PMNs. Based on structural analogy to epoxides, EPA is concerned that
toxicity to aquatic organisms from the PMN substances may occur at a
concentration as low as 10 ppb in surface waters. Since significant
environmental releases are not expected as described in the PMNs, EPA
has not determined that the proposed manufacturing, processing, and use
of the PMN substances may present an unreasonable risk. EPA has
determined, however, that other uses of the PMN substances may result
in releases that 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substances. The fish and daphnid tests should be
done using the flow-though method and measured concentrations. The
algae test should be done using the static method and measured
concentrations.
CFR citation: 40 CFR 721.2685.
PMN Number P-99-1075
Chemical name: 2-Propenoic acid, 2-methyl-, (octahydro-4,7-methano-1H-
indene-5,?- diyl)bis(methylene) ester.
CAS number: 43048-08-4.
Basis for action: The PMN substance will be used as a coating agent for
resin curing. Based on analogy to methacrylates and esters, EPA is
concerned that toxicity to aquatic organisms from the PMN substance may
occur at a concentration as low as 5 ppb in surface waters. EPA
determined that use of the PMN substance as described in the PMN did
not present an unreasonable risk because the PMN substance is imported
and would not be released to surface waters. EPA has determined that
domestic manufacturing and other uses of the PMN substance may result
in releases to surface waters which exceed the concern concentration.
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), a daphnid chronic toxicity study
(OPPTS 850.1300 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.8485.
PMN Number P-99-1202
Chemical name: (generic) Sulfonyl azide intermediate.
CAS number: Not available
Basis for action: The PMN substance will be used as a reactive additive
for polymers. Based on structural analogy to azides, 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 environmental
releases are not expected as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that any release of the PMN substance to surface waters may
cause significant adverse environmental effects. Based on this
information the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii). Also, based on submitted test data, EPA has
identified concerns for blood, kidney and lung toxicity from inhalation
exposure to the PMN substance. Since significant human exposure is
unlikely when used as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the PMN substance
may present an unreasonable risk. EPA has determined, however, that use
of the
[[Page 70161]]
PMN substance as a powder may result in significant human exposure.
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 fish chronic toxicity
study (OPPTS 850.1400 test guideline), a daphnid chronic toxicity study
(OPPTS 850.1300 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should use a
flow-through method and measured concentrations. The algal toxicity
test should use the static method and measured concentrations. A 90-day
inhalation toxicity study (OPPTS 870.3465 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.983.
PMN Number P-99-1288
Chemical name: (generic) Substituted anilino halobenzamide.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogues for anilines and 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 environmental releases are not expected as described in the PMN,
EPA has not determined that the proposed manufacturing, processing, and
use of the PMN substance may present an unreasonable risk. EPA has
determined, however, that domestic manufacture may result in release of
the PMN substance to surface waters which may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
performed with a flow-through method and measured concentrations. The
algal test should be done with measured concentrations. A stock
solution of the PMN substance should be prepared and its pH adjusted to
pH 7 with either HCl or NaOH.
CFR citation: 40 CFR 721.4096.
PMN Number P-99-1295
Chemical name: (generic) Chlorohydroxyalkyl butyl ether.
CAS number: Not available
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to halo alcohols, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 3 ppb of the PMN substance in surface waters. Since environmental
releases are not expected as the PMN substance is not released to
surface waters above 3 ppb, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that other uses of the PMN substance resulting in release to
surface waters 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 a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
performed under flow through conditions with measured concentrations.
The algal test should be performed under static conditions with
measured concentrations.
CFR citation: 40 CFR 721.3438.
PMN Number P-99-1304
Chemical name: (generic) Substituted benzenesulfonic acid salt.
CAS number: Not available.
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 2 ppb of the PMN substance in surface waters.
Since significant environmental releases are not expected, as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk to the environment. EPA has determined, however, that other uses
of the PMN substance resulting in release to surface waters in
significant amounts, may cause significant adverse environmental
effects. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii). Also, based on structural
analogues, EPA has identified concerns for lung effects from inhalation
exposure to the PMN substance. Since significant human exposure is
unlikely for the use described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the PMN substance
may present an unreasonable risk to human health. EPA has determined,
however, that other uses of the PMN substance, may result in
significant human exposure. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) 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. A stock solution should be prepared and its pH adjusted
to 7.0 with either HCl or NaOH. A 90-day inhalation toxicity study
(OPPTS 870.3465 test guideline) would help to characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.1648.
PMN Number P-99-1341
Chemical name: 2-Naphthalenecarboxylic acid, 4,4'-methylenebis [3-
hydroxy-, strontium salt.
CAS number: 235083-90-6.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to phenols, anionic surfactants, and
inorganic metal salts, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 3 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
above10 ppb, as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the PMN substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the PMN 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); a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. All studies should use the
[[Page 70162]]
static method and nominal concentrations.
CFR citation: 40 CFR 721.5253.
PMN Number P-99-1342
Chemical name: 2-Naphthalenecarboxylic acid, 4,4'-methylenebis [3-
hydroxy-, zinc salt
CAS number: 235083-88-2.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to phenols, anionic surfactants, and
inorganic metal salts, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 3 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 PMN substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the PMN 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. All studies should use the static method
and nominal concentrations.
CFR citation: 40 CFR 721.5252.
PMN Number P-00-7
Chemical name: D-Glucuronic acid, polymer with 6-deoxy-L-mannose and D-
glucose, acetate, calcium magnesium potassium sodium salt.
CAS number: 125005-87-0.
Basis for action: The PMN substance will be used as an oilfield
drilling fluid, an oilfield spacer fluid, in oilfield cementing, in
cementitious packaged products, in concrete applications, and in foam
applications. Based on structural analogues and submitted test data,
EPA has identified concerns for lung effects from inhalation exposure
to the PMN substance. Since significant inhalation exposure is unlikely
when used as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the PMN substance may
present an unreasonable risk. EPA has determined, however, that use of
the PMN substance other than as described in the PMN may result in
significant human exposure. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(i) and
(b)(3)(ii).
Recommended testing: EPA has determined that the 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), (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 in the 90-day study.
CFR citation: 40 CFR 721.2076.
PMN Number P-00-368
Chemical name: (generic) Benzenesulfonamide,
alkylphenylsubstitutedphenyl substituted carbonyl-.
CAS number: Not available.
Effective date of section 5(e) consent order: March 28, 2001.
Basis for section 5(e) consent order: The Order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that the PMN substance may present an unreasonable risk of injury to
human health and the environment.
Recommended testing: EPA has determined that a subchronic inhalation
toxicity study (OPPTS 870.3465) would help to characterize the
potential health effects of the PMN substance. EPA has also determined
that a fish chronic toxicity study (OPPTS 850.1400) and a daphnid
chronic toxicity test (OPPTS 850.1300) would help to characterize
potential environmental effects.
CFR citation: 40 CFR 721.1620.
PMN Number P-00-636
Chemical name: (generic) Alkylated nitroso-phenylenediamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymerization
inhibitor. Based on test data for the PMN substance and analogy to
structurally similar compounds, EPA has identified human health
concerns for systemic effects, reproductive effects, and cancer from
dermal exposure to the PMN substance. Since significant worker exposure
is unlikely when the PMN substance is used as described in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the PMN substance may present an unreasonable risk. EPA has
determined, however, that use of the PMN substance without dermal
protection could result in worker exposures which may cause significant
adverse human 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: The Agency has determined that the results of a 2-
generation reproduction/fertility effects study (OPPTS 870.3800 test
guideline) and a carcinogenicity study (OPPTS 870.4200 test guideline)
would help to characterize possible human health effects of the PMN
substance.
CFR citation: 40 CFR 721.5935.
PMN Number P-00-838
Chemical name: (generic) Substituted alkyl sulfonamide.
CAS number: Not available.
Basis for action: The PMN substance will be used for a contained use in
an article. Based on structural analogy to neutral organic compounds,
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 waters above 1 ppb, EPA has not
determined that the proposed processing and use of the PMN substance
may present an unreasonable risk. EPA has determined, however, that
releases 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 a
fish chronic toxicity study (OPPTS 850.1400 test guideline) would help
to characterize possible environmental effects of the PMN substance.
This test should be conducted with flow-through conditions and measured
concentrations.
CFR citation: 40 CFR 721.9572.
PMN Number P-00-912
Chemical name: (generic) Epoxy resin containing phosphorus.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for carcinogenicity,
reproductive toxicity in males, and developmental toxicity based on
structural analogy to epoxides. EPA also identified health and
environmental concerns because the PMN substance may be persistent,
bioaccumulative, and potentially toxic based on physical/chemical
properties of the PMN substance as described in the New Chemical
Program's Persistent, Bioiaccumulative, and Toxic (PBT) Category (64 FR
60194, FRL-6907-7, November 4, 1999). Since significant worker and
environmental exposure is
[[Page 70163]]
unlikely when used as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the PMN 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 chronic effects and
significant environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170 (b)(l)(i)(C),
(b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemical Program's PBT Category would
help to characterize the PBT properties of the PMN substance. EPA has
also determined that a fish chronic toxicity study (OPPTS 850.1400 test
guideline), a daphnid chronic toxicity study (OPPTS 850.1300 test
guideline), and an algal toxicity study (OPPTS 850.5400 test guideline)
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. In addition,
a 2-year, two-species oral carcinogenicity study (OPPTS 870.4200 test
guideline) and a 90-day oral subchronic in rats (OPPTS 870.3100 test
guideline), with attention to pathology of the reproductive organs,
would help to characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2752.
PMN Number P-00-966
Chemical name: (generic) Haloarylalkylketoester.
CAS number: Not available.
Basis for action: The PMN substance will be used as an agricultural
product intermediate. Toxicity data on structurally similar esters
indicate that the PMN substance may cause toxicity to aquatic
organisms. Based on this data, EPA expects toxicity to aquatic
organisms to occur at a concentration as low as 200 ppb of the PMN
substance in surface waters. Since environmental releases to surface
waters are not expected to exceed 200 ppb, EPA has not determined that
the proposed processing and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that if releases to
surface waters were to exceed a concentration of 200 ppb, the PMN
substance 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 an algal toxicity
test (OPPTS 850.5400 test guideline), an aquatic invertebrate acute
toxicity test (OPPTS 850.1010 test guideline), and a fish acute
toxicity test (OPPTS 850.1075 test guideline) would help to
characterize possible environmental effects of the PMN substance. Ready
biodegradation testing (OPPTS 835.3110 test guideline) would help to
characterize possible environmental effects of the PMN substance as
well. The aquatic toxicity tests should be conducted with flow-through
conditions and measured concentrations.
CFR citation: 40 CFR 721.3062.
PMN Number P-00-991
Chemical name: Formaldehyde, polymer with (chloromethyl) oxirane and
phenol, reaction products with 6H-dibenz[c,e][1,2]oxaphosphorin-6-
oxide.
CAS number: 300371-38-4.
Basis for action: The PMN substances will be used in the manufacturing
of composites. Based on structural analogy to epoxides, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 6 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 above 6 ppb, as described
in the PMNs, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substances may present an unreasonable
risk. EPA has determined, however, that other uses of the PMN
substances resulting in release to surface waters above 6 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal acute toxicity study
(OPPTS 850.5400 test guideline) would help to characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.5560
PMN Number P-00-1055
Chemical name: (generic) Sulfonated-copper phthalocyanine salt of a
triarylmethane dye
CAS number: Not available.
Basis for action: The PMN substance will be used as a shading additive
for ink. Based on analogy to cationic dyes, 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 waters above 1 ppb, as described in the PMN, EPA
has not determined that proposed manufacturing, processing, and use of
the use of the PMN substance may present an unreasonable risk. EPA has
determined, however, that other uses of the PMN substance resulting in
release to surface waters above 1 ppb may cause significant adverse
environmental effects. Also, based on analogy to triarylmethane
pigments and dyes, EPA has identified health concerns for mutagenicity
and cancer effects from inhalation exposure to the PMN substance. Since
significant inhalation exposure is unlikely when the PMN substance is
used described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
substance in the form of a powder may result in significant human
exposure. Based on this information, the PMN substance meets the
concern criteria at Sec. 721.170(b)(4)(ii) and (b)(l)(i)(C).
Recommended testing: EPA has determined that a developmental toxicity
study with two species (rats and mice) by gavage (OPPTS 870.3700 test
guideline), a 2-generation reproductive and toxicity study (OPPTS
870.3800 test guideline), an Ames assay/salmonella study (OPPTS
870.5100 test guideline), a micronucleus assay (OPPTS 870.5395 test
guideline), and a carcinogenicity study in rats (OPPTS 870.4200 test
guideline) would help to characterize human health effects. In
addition, a fish acute toxicity study (OPPTS 850.1075 test guideline),
a daphnid acute toxicity study (OPPTS 850.1010 test guideline), and an
algal acute toxicity study (OPPTS 850.5400 test guideline) would help
to characterize the environmental effects.
CFR citation: 40 CFR 721.9674.
PMN Number P-00-1205
Chemical name: (generic) 6-Methoxy-1H-benz[de]isoquinoline-2 [3H]-dione
derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate in
the manufacture of aqueous dyes. Toxicity data on structurally similar
chemicals indicate that the PMN substance may cause toxicity to aquatic
organisms. Based on this data, EPA expects toxicity to aquatic
organisms to occur at a concentration of 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 waters above
30 ppb, EPA has not determined that the
[[Page 70164]]
proposed processing and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
PMN 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: The Agency has determined that the results of a
fish acute toxicity test (OPPTS 850.1075 test guideline) and a fish
acute toxicity mitigated by humic acid (OPPTS 850.1085 test guideline),
and an activated sludge sorption/desorption isotherm test (OPPTS
835.1110 test guideline) would help to characterize environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.9078.
PMN Number P-00-1220
Chemical name: (generic) Phenol-biphenyl polymer condensate.
CAS number: Not available.
Basis for action: The PMN substance will be used as an electric
molding. 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 PMN substance is not
released to surface water, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that any release of the
PMN substance to surface water may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal acute toxicity study
(OPPTS 850.5400 test guideline) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5713.
PMN Number P-01-1
Chemical name: (generic) Chloroformate.
CAS number: Not available
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to acid halides and neutral organic compounds, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 2 ppb of the PMN substance and 70 ppb of the
PMN substance's hydrolysis product in surface waters. EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk as the PMN substance is
not released to surface waters above 2 ppb. EPA has determined,
however, that other uses of the PMN substance resulting in releases to
surface waters above 2 ppb may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a hydrolysis study at 25
[deg]C and pH 7 (OPPTS 835.2120 test guideline), a ready
biodegradability study (OPPTS 835.3110 test guideline), a fish acute
toxicity study (OPPTS 850.1075 test guideline), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline), and an algal acute
toxicity study (OPPTS 850.5400 test guideline) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.3835.
PMN Number P-01-7
Chemical name: (generic) Ethylenediaminetetraacetic acid mixed salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified concerns for reproductive toxicity in males and
mutagenicity based on submitted test data, and carcinogenicity based on
analogy to nitrilotriacetic acid. Since significant worker exposure is
unlikely when the PMN substance is used as described in the PMN, EPA
has not determined that the proposed processing and use of the PMN
substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture or use of the PMN 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)(i) and (b)(l)(i)(C).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two species (OPPTS 870.3700) and a
carcinogenicity study in rats (OPPTS 870.4200) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.2098.
PMN Number P-01-9
Chemical name: (generic) Halogenated arylsilane.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified environmental concerns because the PMN
substance may be persistent, bioaccumulative, and potentially toxic
based on physical/chemical properties of the PMN substance as described
in the New Chemical Program's PBT Category. Also, based on structural
analogy to neutral organics, EPA expects toxicity to aquatic organisms
at surface water concentrations as low as 1 ppb. 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
PMN substance may present an unreasonable risk. EPA has determined,
however, that 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 Category would
help to characterize the PBT properties of the PMN substance. EPA has
determined that the results of a fish chronic toxicity study (OPPTS
850.1400), a daphnid chronic toxicity study (OPPTS 850.1300), and an
algal toxicity study (OPPTS 850.5400) 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.
CFR citation: 40 CFR 721.9506.
PMN Number P-01-22
Chemical name: Propanoic acid, 2-(trimethoxysilyl)-, ethyl ester.
CAS number: 137787-41-8.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to alkoxysilanes, 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 above 10 ppb, as described in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the PMN substance may present an unreasonable risk. EPA has
determined, however, that other uses of the PMN 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).
[[Page 70165]]
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075), a daphnid acute toxicity study (OPPTS
850.1010), and an algal toxicity study (OPPTS 850.5400) would help to
characterize the environmental effects of the PMN substance. The fish
and daphnid tests should be conducted with flow-through conditions and
measured concentrations. The algae test should be conducted with static
conditions and measured concentrations.
CFR citation: 40 CFR 721.7290.
PMN Number P-01-69
Chemical name: (generic) Substituted naphthalene hydrazide.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to phenols and hydrazines. 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 environmental releases are not expected as described in the PMN,
EPA has not determined that the proposed manufacturing, processing and
use of the PMN substance as described in the PMN may present an
unreasonable risk. EPA has determined, however, that any release of the
PMN substance to surface waters may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (OPPTS 850.1075 test guideline), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
conducted with the flow-through method and measured concentrations. The
algae test should be conducted with the static method and measured
concentrations.
CFR citation: 40 CFR 721.4258.
PMN Number P-01-71
Chemical name: Phenol, 2,2'-[6-(2,4-dibutoxyphenyl)-1,3,5-triazine-2,4-
diyl]bis[5-butoxy-.
CAS number: 208343-47-9.
Basis for action: The PMN substance will be used as an ultraviolet
absorber for use in photographic emulsions. 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 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 PMN substance may present an
unreasonable risk. EPA has determined, however, that any release to
surface waters 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 chronic toxicity
study (OPPTS 850.1400 test guideline), and a daphnid chronic toxicity
study (OPPTS 850.1300 test guideline) would help to characterize the
environmental effects of the PMN substance. The fish and daphnid
studies should be conducted with flow-through method and measured
concentrations.
CFR citation: 40 CFR 721.5718.
PMN Number P-01-77
Chemical name: (generic) Disubstituted benzenedicarboxcylic acid.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for developmental toxicity
based on structural analogy to phthalate esters. Since significant
worker exposure is unlikely when the PMN substance is used as described
in the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that use of the PMN substance other
than as an intermediate 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). Also, based on
structural analogy to esters, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 12 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 PMN substance as
described in the PMN may present an unreasonable risk. EPA has
determined, however, that other uses of the PMN 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 Combined Repeated Dose
with Reproductive/Developmental Toxicity (OPPTS 870.3650) or a
Reproductive/Development Toxicity Test (OPPTS 870.3550) 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), a
daphnid acute toxicity study (OPPTS 850.1010), and an algal toxicity
study (OPPTS 850.5400) would help characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
conducted with the flow-through conditions and measured concentrations.
The algae test should be conducted with the static method and measured
concentrations.
CFR citation: 40 CFR 721.2060.
PMN Number P-01-85
Chemical name: (generic) Mono esters from 2-propenoic acid.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to 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 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
PMN substance may present an unreasonable risk. EPA has determined,
however, that any 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. All tests should be conducted with flow-
through methods and measured concentrations.
CFR citation: 40 CFR 721.8340.
PMN Number P-01-97
Chemical name: (generic) Polyaziridinyl ester of an aliphatic alcohol.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for mutagenicity,
carcinogenicity, male reproductive toxicity, and developmental toxicity
based on structural analogy to epoxides. Since significant worker
exposure is unlikely, when used as described in the PMN, EPA has not
determined that the proposed manufacturing, processing,
[[Page 70166]]
and use of the PMN substance may present an unreasonable risk. EPA has
determined, however, that use of the PMN substance other than as
described in the PMN may result in serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(3)(ii) and (b)(l)(i)(C).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (OPPTS 870.3100 test guideline), with attention
to pathology of the reproductive organs, and a carcinogenicity study in
rats (OPPTS 870.4200 test guideline) would help to characterize the
human health effects of the PMN substance.
CFR citation: 40 CFR 721.7250.
PMN Number P-01-144
Chemical name: Propanamide, N-(2-hydroxyethyl)-3-methoxy-.
CAS number: 35544-45-7.
Basis for action: The PMN substance will be used as an organic stripper
additive. EPA has identified health concerns for the solvent properties
of the PMN substance. Since significant worker exposure is unlikely,
when the PMN substance is used as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN 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 prenatal developmental
toxicity study (OPPTS 870.3700 test guideline), a 28-day oral toxicity
study in rats (OPPTS 870.3050) that includes a neurotoxicity functional
observational battery (NTIS: PB 91-154617) for all test doses with the
highest test dose set at 1,000 mg/kg, and for the highest test dose
group only, histopathologic examination shall be extended to include
testes/ovaries and lungs, an acute oral toxicity (OPPTS 870.1100 test
guideline), a mammalian erythrocyte micronucleus test (OPPTS 870.5395
test guideline), and a salmonella typhimurium reverse mutation assay
(OPPTS 870.5265 test guideline) would help to characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.8130.
PMN Number P-01-149
Chemical name: Sulfuric acid, mono-C9-11-alkyl esters,
sodium salts.
CAS number: 84501-49-5.
Basis for action: The PMN substance will be used as a component in
surfactant/foaming agent for leather processing. Based on structural
activity relationship analysis, EPA has identified health concerns for
internal organ effects. Since significant worker exposure is unlikely,
when the PMN substance is used as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that an increase in production volume 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 (OPPTS 870.3100 test guideline) would help to
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.3130.
PMN Number P-01-152
Chemical name: Benzenamine, 4-methoxy-2-methyl-N-(3-methylphenyl)-.
CAS number: 93072-06-1.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to neutral organic compounds, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 5 ppb of the PMN substance in surface waters.
EPA also identified environmental concerns because the PMN substance
may be persistent, bioaccumulative, and potentially toxic based on
physical/chemical properties of the PMN substance as described in the
New Chemical Program's PBT Category. Since significant environmental
exposure is not expected as the PMN substance is not released to
surface water above 5 ppb, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that other uses of the PMN substance resulting in release to
surface waters above 5 ppb may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170 (b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemicals Program's PBT Category would
help to characterize the PBT properties of the PMN substance. EPA has
determined that the results of a fish acute toxicity study (OPPTS
850.1075 test guideline), a daphnid acute toxicity study (OPPTS
850.1010 test guideline), and an algal toxicity study (OPPTS 850.5400
test guideline) would help to characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.1070.
PMN Number P-01-170
Chemical name: Acetic acid, [(5-chloro-8-quinolinyl)oxy-]-, 1-
methylhexyl ester.
CAS number: 99607-70-2.
Basis for action: The PMN substance will be used as a seed safener.
Based on test data, there is concern for liver toxicity and thyroid
effects. Since significant worker exposure is unlikely, EPA has not
determined that the proposed processing, and use of the PMN substance
may present an unreasonable risk. EPA has determined, however, that
domestic manufacture or use without protective equipment may cause
serious health effects. Based on this information, the PMN substance
meets the concern criteria in Sec. 721.170(b)(3)(i).
Recommended testing: The Agency recommends no further toxicity testing
for hazard assessment of the PMN substance. However, additional
information on human exposures to the PMN substance would help to
characterize potential risks.
CFR citation: 40 CFR 721.304.
PMN Number P-01-298
Chemical name: (generic) Substituted propane
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymer additive.
EPA has identified health concerns for mutagenicity, neurotoxicity,
developmental toxicity, liver toxicity and kidney toxicity based on
submitted test data. 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 PMN substance may
cause significant adverse effects. EPA has determined, however, that
use of the PMN substance other than as described in the PMN may result
in 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 prenatal development
toxicity study by the oral route in two species (OPPTS 870.3100 test
guideline) would help to characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.8140.
PMN Number P-01-320
Chemical name: Propane, 1, 1,1,2,2,3,3-heptafluoro-3-methoxy-.
CAS number: 375-03-1.
Basis for action: The PMN substance will be used as heating transfer
fluid and a refrigerant. EPA has identified
[[Page 70167]]
health concerns for liver and kidney toxicity based on submitted test
data and cardiac sensitization and developmental toxicity based on
analog data. Since significant worker exposure is unlikely, when the
PMN substance is used described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the PMN substance
may present an unreasonable risk. EPA has determined, however, that an
increase in production volume or use of the PMN substance other than as
described in the PMN could result in serious health effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rodents (OPPTS 870.3465 test guideline) would help
to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.8145.
PMN Number P-01-397
Chemical name: (generic) Dihydro quinacridone derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to neutral organic compounds, 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 2 ppb, as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that an increase in production
volume or other uses of the PMN substance resulting in releases to
surface waters above 2 ppb may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish chronic toxicity
study (OPPTS 850.1400 test guideline), a daphnid chronic toxicity study
(OPPTS 850.1300 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
conducted with flow-through conditions and measured concentrations. The
algae test should be conducted with static condition and nominal
concentrations.
CFR citation: 40 CFR 721.9079.
PMN Number P-01-420
Chemical name: (generic) Aromatic acrylate.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to acrylates, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 3
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
PMN substance may present an unreasonable risk. EPA has determined,
however, that other uses of the PMN 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.330.
PMN Number P-01-423
Chemical name: (generic) Substituted benzoic acid.
CAS number: Not available.
Basis for action: The PMN substance will be used as a dye intermediate.
EPA has identified health concerns for developmental toxicity,
irritation to lung, skin, eyes, and mucous membranes, blood toxicity,
male reproductive toxicity, and dermal sensitization based on analogue
data. Since significant worker exposure is unlikely, when the PMN
substance is used as described in the PMN, EPA has not determined that
the proposed processing, and use of the PMN 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).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rodents (OPPTS 870.3465 test guideline) would help
to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.1680.
PMN Number P-01-433
Chemical name: (generic) Halogenated alkane.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to structural analogues, EPA has concerns for
carcinogenicity and cardiac sensitization. Also, based on analogy to
neutral organic chemicals, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 400 ppb of the PMN
substance in surface waters. Since significant worker and environmental
exposure is unlikely, when the PMN 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
determined, however, that use of the PMN substance other than as an
intermediate may 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) and (b)(4)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rodents (OPPTS 870.3465 test guideline) and a
cardiac sensitization study 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), a daphnid acute
toxicity study (OPPTS 850.1010 test guideline), and an algal toxicity
study (OPPTS 850.5400 test guideline) would help to characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.535.
PMN Number P-01-441
Chemical name: (generic) Modified phenolic resin
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified environmental concerns because the PMN
substance may be persistent, bioaccumulative, and potentially toxic
based on physical/chemical properties of the PMN substance as described
in the New Chemical Program's PBT Category. 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 based on structural analogy
to phenols. Since 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 PMN substance may present an unreasonable risk. EPA has
[[Page 70168]]
determined, however, that other uses of the PMN 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 tiered
testing as described in the New Chemical Program's PBT Category would
help to characterize the PBT properties of the PMN substance. EPA has
also determined that a fish acute toxicity study (OPPTS 850.1075 test
guideline), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline), and an algal toxicity study (OPPTS 850.5400 test guideline)
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.5905.
PMN Number P-01-459
Chemical name: Chromate(3-), bis[3-[[6-amino-1,4-dihydro-2-[[[4-[(2-
hydroxy-1-naphthalenyl)azo] phenyl]sulfonyl]amino]-4-(oxo-.kappa.O)-5-
pyrimidinyl]azo-.kappa.N1]-4-(hydroxy-.kappa.O)-5-
nitrobenzenesulfonato(3-)]-, trisodium.
CAS number: 178452-72-7
Basis for action: The PMN substance will be used as an acid dye for
dyeing leather. Based on submitted test data, EPA has identified human
health concerns for blood, liver, and spleen effects. Since significant
worker exposure is unlikely, as inhalation exposure is not expected for
the use described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
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)(i).
Recommended testing: EPA has determined that a 90-day inhalation 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 721.8940.
PMN Number P-01-460
Chemical name: Chromate(3-), bis[3-[[6-amino-1,4-dihydro-2-[[[4-[(2-
hydroxy-1-naphthalenyl)azo] phenyl]sulfonyl]amino]-4-(oxo-.kappa.O)-5-
pyrimidinyl]azo-.kappa.N1]-4-(hydroxy-.kappa.O)-5-
nitrobenzenesulfonato(3-)]-, sodium triethanolamine salts.
CAS number: 327177-98-0.
Basis for action: The PMN substance will be used as an acid dye for
dyeing leather. Based on submitted test data, EPA has identified human
health concerns for blood, liver, and spleen effects. Since significant
worker exposure is unlikely, as inhalation exposure is not expected for
the use described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that use of the PMN
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)(i).
Recommended testing: EPA has determined that a 90-day inhalation 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 721.8950.
PMN Numbers P-00-992 and P-01-471
Chemical name: (generic) Phosphorous modified epoxy resin.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to epoxides, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 6
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 6 ppb, as described in the PMN, EPA has
not determined that the proposed manufacturing, processing, and use of
the PMN substance may present an unreasonable risk. EPA has determined,
however, that use of the PMN substance other than as described in the
PMN could cause releases to surface waters above 6 ppb which may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish chronic toxicity
study (OPPTS 850.1400 test guideline), a daphnid chronic toxicity study
(OPPTS 850.1300 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance. The fish and daphnid tests should be
conducted with flow-through conditions and measured concentrations. The
algae test should be conducted with static conditions and nominal
concentrations.
CFR citation: 40 CFR 721.3135.
PMN Number P-01-481
Chemical name: (generic) Polyurethane polymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on physical/ chemical properties and submitted test data,
EPA has identified health concerns for inhalation exposure. Since
significant inhalation exposure to workers is unlikely, when the PMN
substance is used as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the PMN substance
may present an unreasonable risk. EPA has determined, however, that use
of the PMN substance other than that 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).
Recommended testing: The Agency is not recommending further toxicity
testing to evaluate potential health effects. However, additional
information on human exposures to the PMN substance would help to
characterize potential health risks.
CFR citation: 40 CFR 721.9959.
PMN Number P-01-561
Chemical name: (generic) Modified phenolic resin.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to polyphenols, 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
PMN substance may present an unreasonable risk. EPA has determined,
however, that any 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.5908.
PMN Number P-01-573
Chemical name: (generic) Aromatic aldehyde phenolic resin
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on structural analogy to phenols, EPA is concerned that
toxicity to
[[Page 70169]]
aquatic organisms may occur at a concentration of 1 ppb in surface
waters. Since significant environmental exposure is unlikely, as the
PMN substance is not released to surface waters, as described in the
PMN, EPA has not determined that manufacturing, processing, and use of
the PMN substance may present an unreasonable risk. EPA has determined,
however, that any 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), a daphnid acute toxicity study
(OPPTS 850.1010 test guideline), and an algal toxicity study (OPPTS
850.5400 test guideline) would help to characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.5762.
PMN Number P-01-578
Chemical name: (generic) Alkoxylated alkyl amine.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to cationic surfactants, 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 unlikely, when the PMN substance is used as
described in the PMN, EPA has not determined that the proposed
manufacturing and use of the PMN 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
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), a daphnid acute toxicity study (OPPTS
850.1010 test guideline), and a fish acute toxicity study (OPPTS
850.1075 test guideline) would help to characterize the environmental
effects of the PMN substance. All tests should be conducted with static
methods and nominal concentrations.
CFR citation: 40 CFR 721.647.
PMN Number P-01-646
Chemical name: 1-propanaminium, 3-amino-, N, N, N-trimethyl-N-soya acyl
derivs., chloride
CAS number: 391232-99-8
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to cationic surfactants, 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 unlikely, when the PMN substance is used as
described in the PMN, EPA has not determined that the proposed
manufacturing and use of the PMN 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
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), a daphnid acute toxicity study OPPTS
850.1010 test guideline), and a fish acute toxicity study (OPPTS
850.1075 test guideline) would help to characterize the environmental
effects of the PMN substance. All tests should be conducted with static
methods and nominal concentrations.
CFR citation: 40 CFR 721.7270
PMN Number P-01-716
Chemical name: (generic) Polyurea.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified environmental concerns because the PMN
substance may be persistent, bioaccumulative, and potentially toxic
based on physical/chemical properties of the PMN substance as described
in the New Chemical Program's PBT category. 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 based on submitted test
data. Since 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 PMN substance may present an unreasonable risk. EPA has
determined, however, that other uses of the PMN 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)(i).
Recommended testing: EPA has determined that the results of the tiered
testing as described in the New Chemical Program's PBT Category would
help to characterize the PBT properties of the PMN substance. EPA has
also determined that an algal toxicity study (OPPTS 850.5400 test
guideline), a fish chronic toxicity study (OPPTS 850.1400 test
guideline), a daphnid chronic toxicity study (OPPTS 850.1300 test
guideline), a fish bioaccumulation test (OPPTS 850.1730), and a shake-
flask die-away test (OPPTS 835.3170 test guideline) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9929.
PMN Number P-01-781
Chemical name: Silane, triethoxy[3-(oxiranylmethoxy)propyl]-
CAS number: 2602-34-8.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for carcinogenicity based on
analogy to epoxides. EPA has concerns also for mutagenicity,
developmental toxicity, reproductive toxicity, irritation, and
sensitization based on analogy to trimethoxy silane derivatives. Since
significant worker exposure is unlikely, when the PMN substance is used
as described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the PMN 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)(1)(i)(C) and (b)(3)(ii) . Also, based on
structural analogy to epoxides, 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 environmental exposure is not
expected as the PMN substance is not released to surface waters above
10 ppb, as described in the PMN, EPA has not determined that the
proposed manufacturing, processing and use of the PMN substance may
present an unreasonable risk. EPA has determined, however, that
releases 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 combined chronic
toxicity/carcinogenicity study (OPPTS 870.4300 test guideline) and a
90-day subchronic inhalation study in rodents with attention to
pathology of the reproductive organs (OPPTS 870.3465 test guidelines)
would help to characterize the health effects of the PMN substance. EPA
has determined that a fish acute toxicity study (OPPTS 850.1075 test
guideline), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline), and an algal toxicity
[[Page 70170]]
study (OPPTS 850.5400 test guideline) would help to characterize the
environmental effects of the PMN substance. The fish and daphnid tests
should be conducted with the flow-through conditions and measured
concentrations. The algae test should be conducted with the static
method and measured concentrations.
CFR citation: 40 CFR 721.9501.
PMN Number P-01-833
Chemical name: (generic) Polyethyleneamine crosslinked with substituted
polyethylene glycol.
CAS number: Not available.
Basis for action: The PMN substance will be used as an absorbent
polymer. Based on toxicity data for other high molecular weight, water
swellable polymers, EPA has identified potential lung toxicity from
inhalation exposure. Since significant inhalation exposure is unlikely
when the PMN substance is used as identified in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
PMN substance may present an unreasonable risk. EPA has determined,
however, that use of the PMN substance other than as described in 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), 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 721.7255.
PMN Number P-02-17
Chemical name: (generic) Phenyl azo dye.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on the submitted 28-day study, EPA has concerns for effects
to the testes. Also, based on structural analogy to the azo reduction
product, EPA has concerns for developmental toxicity, hemolytic anemia,
kidney toxicity, liver toxicity, spleen toxicity, and irreversible
ocular phototoxicity. Since significant inhalation exposure to workers
is unlikely for the use described in the PMN, EPA has not determined
that manufacturing, processing, and use of the PMN substance as
described in the PMN may present an unreasonable risk. EPA has
determined, however, that use of the PMN 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)(i) and (b)(3)(ii).
Recommended testing: EPA has 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 721.5917.
PMN Number P-02-90
Chemical name: (generic) Nickel, cobalt mixed metal oxide.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. EPA has identified health concerns for developmental toxicity,
mutagenicity, carcinogenicity, cardiotoxicity, immunotoxicity,
neurotoxicity, and allergenicity based on the presence of various metal
oxides as well as lung effects from exposure to insoluble particles and
pulmonary carcinogenicity due to the crystalline nature of the PMN
material. 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 PMN substance may cause
significant adverse effects. EPA has determined, however, that domestic
manufacture or use of the PMN substance other than as described in the
PMN 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
inhalation toxicity study in rat (OPPTS 870.3465 test guideline) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5315.
PMN Number P-02-207
Chemical name: Piperdinium, 1,1-dimethyl-, chloride.
CAS number: 24307-26-4.
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 neurotoxicity and chronic toxic effects for the PMN substance.
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 PMN substance may cause significant adverse
effects. EPA has determined, however, that use of the PMN substance
other than as described in the PMN may result in serious health
effects. Also, based on structural analogy to cationic surfactants, EPA
is concerned that toxicity to aquatic organisms may occur at surface
water concentrations as low as 300 ppb of the PMN substance in surface
waters. Since environmental releases are not expected as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the PMN substance may present an unreasonable
risk. EPA has determined, however, that release of the PMN substance to
surface water may cause significant adverse environmental effects.
Based on this information, the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(i), and (b)(4)(ii).
Recommended testing: EPA has determined that information on potential
human and environmental exposures would help to characterize the
potential health and environmental risks of the PMN substance.
CFR citation: 40 CFR 721.6167.
PMN Number P-02-262
Chemical name: (generic) Substituted benzophenone.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to benzophenones, EPA has identified health
concerns for neurotoxicity and liver toxicity. Since significant worker
exposure is unlikely when the PMN substance is used as described in the
PMN, EPA has not determined that the proposed processing, and use of
the PMN substance may present an unreasonable risk. EPA has determined,
however, that domestic manufacture of the PMN substance 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). Also, based on structural analogy to neutral organic
chemicals, 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 environmental releases are not expected as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing and use of the PMN substance may present an
unreasonable risk. EPA has determined, however, that any release of the
PMN substance to surface water may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a 90-day oral
[[Page 70171]]
subchronic study in rats (OPPTS 870.3465 test guideline) would help
characterize the human health effects of the PMN substance. EPA has
also determined that a fish acute toxicity study (OPPTS 850.1075 test
guideline), a daphnid acute toxicity study (OPPTS 850.1010 test
guideline), and an algal acute toxicity study (OPPTS 850.5400 test
guideline) would help to characterize the environmental effects of the
PMN substance.
CFR citation: 40 CFR 721.1747.
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 5 of the 65
chemical substances, regulation was warranted under section 5(e) of
TSCA, pending the development of information sufficient to make
reasoned evaluations of the health or environmental effects of the
chemical substances. The basis for such findings is outlined in Unit
III. Based on these findings, TSCA section 5(e) consent orders
requiring the use of appropriate exposure controls were negotiated with
the PMN submitters; the SNUR provisions for these chemical substances
listed in this document are consistent with the provisions of the TSCA
section 5(e) consent orders.
In the other 60 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 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 chemical
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 chemical substance is listed on the TSCA Inventory. Manufacturers,
importers, and processors are responsible for ensuring that a new
chemical substance subject to a final SNUR is listed on the TSCA
Inventory.
V. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR
721.160(c)(3)(ii), this rule will be effective February 17, 2004,
unless EPA receives a written notice by January 16, 2004, of adverse or
critical comments, or notice of intent to submit adverse or critical
comments on EPA's action. If EPA receives such a notice, EPA will
publish a document to withdraw the direct final SNUR for the specific
chemical substance to which the adverse or critical comments apply. EPA
will then propose a SNUR for the specific chemical substance providing
a 30-day comment period.
This action establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments or notice of intent
to submit adverse or critical comments, must identify the chemical
substance and the new use to which it applies. EPA will not withdraw a
SNUR for a chemical substance not identified in a notice.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. Persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them. 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 chemical 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 chemical substances. These production
limits cannot be exceeded unless the PMN submitter first submits the
results of toxicity tests that would permit a reasoned evaluation of
the potential risks posed by these chemical substances. Under recent
consent orders, each PMN submitter is required to submit each study at
least 14 weeks (earlier consent orders required submissions at least 12
weeks) before reaching the specified production limit. Listings of the
tests specified in the TSCA section 5(e) consent orders are included in
Unit III. The SNURs contain the same production volume limits as the
consent orders. Exceeding these production limits is defined as a
significant new use.
The recommended studies may not be the only means of addressing the
potential risks of the chemical substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under TSCA section 5(e), particularly if
satisfactory test results have not been obtained from a prior
submitter. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on:
1. Human exposure and environmental release that may result from
the significant new use of the chemical substances.
2. Potential benefits of the chemical substances.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule 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 chemical 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 in Sec. 721.1725(b)(1), a manufacturer or importer must show
that it has a bona fide intent to manufacture or import the chemical
substance and must identify the specific use for which it intends to
manufacture or import the chemical substance. If EPA concludes that the
person has shown a bona fide intent to manufacture or import the
chemical substance, EPA will tell the person whether the use identified
in the bona fide submission would be a significant new use under the
rule. Since most of the chemical identities of the chemical substances
[[Page 70172]]
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec. 721.11 into a single step.
If a manufacturer or importer is told that the production volume
identified in the bona fide submission would not be a significant new
use, i.e., it is below the level that would be a significant new use,
that person can manufacture or import the chemical substance as long as
the aggregate amount does not exceed that identified in the bona fide
submission to EPA. If the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use. EPA is considering
whether to adopt a special procedure for use when CBI production volume
is designated as a significant new use. Under such a procedure, a
person showing a bona fide intent to manufacture or import the chemical
substance, under the procedure described in Sec. 721.11, would
automatically be informed of the production volume that would be a
significant new use. Thus, the person would not have to make multiple
bona fide submissions to EPA for the same chemical substance to remain
in compliance with the SNUR, as could be the case under the procedures
in Sec. 721.1725(b)(1).
VIII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
To establish a significant "new" use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. TSCA section 5(e) consent
orders have been issued for 5 chemical substances and notice submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received an NOC and the chemical substance has not
been added to the TSCA Inventory, no other person may commence such
activities without first submitting a PMN. For chemical substances for
which an NOC has not been submitted at this time, EPA has concluded
that the uses are not ongoing. However, EPA recognizes in cases when
chemical substances identified in this SNUR are added to the Inventory
prior to the effective date of the rule, the chemical substances may be
manufactured, imported, or processed by other persons for a significant
new use as defined in this rule before the effective date of the rule.
However, 45 of the 65 chemical substances contained in this rule have
CBI chemical identities, and since EPA has received a limited number of
post-PMN bona fide submissions, 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
chemical substances regulated through this SNUR will have to cease any
such activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of the chemical 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 substances subject to this rule. EPA's complete economic
analysis is available in the public docket.
X. Statutory and Executive Order Reviews
1. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that 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.
2. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 574). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
3. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR applies to any person (including small
or large entities) who intends to engage in any activity described in
the rule as a "significant new use." By definition of the word
"new," and based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activity. Since a SNUR only requires that any person who intends to
engage in such activity in the
[[Page 70173]]
future must first notify EPA by submitting a SNUN, no economic impact
will even occur until someone decides to engage in those activities.
Although some small entities may decide to conduct such activities in
the future, EPA cannot presently determine how many, if any, there may
be. However, EPA's experience to date is that, in response to the
promulgation of over 1,000 SNURs, the Agency receives on average only
10 notices per year. Of those SNUNs submitted, none appear to be from
small entities in response to any SNUR. In addition, the estimated
reporting cost for submission of a SNUN (see Unit IX.), 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.
4. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any 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).
5. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
6. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This does
not significantly or uniquely affect the communities of Indian Tribal
governments, nor does it involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000), do not apply to this rule.
7. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
8. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.
9. National Technology Transfer Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
10. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
11. Executive Order 12630: Governmental Actions and Interference With
Constitutionally Protected Property Rights (Takings)
EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 15, 1988), by examining the takings
implications of this rule in accordance with the "Attorney General's
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings" issued under the Executive order.
12. Executive Order 12988: Civil Justice Reform
In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
13. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., 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: December 7, 2003.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
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Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
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1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
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2. By adding new Sec. 721.304 to subpart E to read as follows
Sec. 721.304 Acetic acid, [(5-chloro-8-quinolinyl)oxy-], 1-methyl
hexyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as acetic acid, [(5-
chloro-8-quinolinyl)oxy-]-, 1-methylhexyl ester (PMN P-01-170;
[[Page 70174]]
CAS No. 99607-70-2) is subject to reporting under this section for the
significant new use described in paragraph (a)(1) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (a)(3), (a)(4), and (a)(5)(iv).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (e), and, (i) are applicable to
manufacturers, importers, and processors of this chemical 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. 721.330 to subpart E to read as follows:
Sec. 721.330 Aromatic acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aromatic acrylate (PMN P-01-420) 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 chemical 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. 721.535 to subpart E to read as follows:
Sec. 721.535 Halogenated alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated alkane (PMN P-01-433) 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 chemical 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. 721.647 to subpart E to read as follows:
Sec. 721.647 Alkoxylated alkyl amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
alkoxylated alkyl amine (PMN P-01-578) 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 chemical 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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6. By adding new Sec. 721.983 to subpart E to read as follows:
Sec. 721.983 Sulfonyl azide intermediate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonyl azide intermediate (PMN P-99-1202) is subject to reporting
under this section for the significant new use described in paragraph
(a)(1) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f), (v)(1), and (x)(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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7. By adding new Sec. 721.1070 to subpart E to read as follows:
Sec. 721.1070 Benzenamine, 4-methoxy-2-methyl-N-(3-methylphenyl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenamine, 4-methoxy-2-methyl-N-(3-methylphenyl) (PMN P-01-152; CAS
No. 93072-06-1) 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=5).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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8. By adding new Sec. 721.1620 to subpart E to read as follows:
Sec. 721.1620 Benzenesulfonamide, alkylphenyl substituted phenyl
substituted carbonyl- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonamide alkylphenyl substituted phenyl substituted carbonyl-
(PMN P-00-368) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
[[Page 70175]]
(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 1.0%), and (c). As an
alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the new
chemical exposure limit (NCEL) provisions listed in the TSCA section
5(e) consent order for this chemical substance.
(ii) Hazard communication program. Requirements as specified in
Sec. 721,72(a), (b), (c), (d), (e) (concentration set at 1.0%), (f),
(g)(1)(iv), (g)(2)(ii), (g)(2)(iv), (g)(3)(ii), (g)(4)(i), and (g)(5).
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=30).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (d), (f), (g), (h), and (k) are applicable to
manufacturers, importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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9. By adding new Sec. 721.1648 to subpart E to read as follows:
Sec. 721.1648 Substituted benzenesulfonic acid salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzenesulfonic acid (PMN P-99-1304) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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10. By adding new Sec. 721.1680 to subpart E to read as follows:
Sec. 721.1680 Substituted benzoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzoic acid (PMN P-01-423) 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 chemical substance.
(2) Limitations 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. 721.1747 to subpart E to read as follows:
Sec. 721.1747 Substituted benzophenone (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted benzophenone (PMN P-02-262) 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. Requirement as specified Sec. 721.90(b)(1)
and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this chemical 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. 721.2060 to subpart E to read as follows:
Sec. 721.2060 Disubstituted benzenedicarboxylic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
disubstituted benzenedicarboxylic acid (PMN P-01-77) 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 chemical 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. 721.2076 to subpart E to read as follows:
Sec. 721.2076 D-Glucuronic acid, polymer with 6-deoxy-L-mannose and
D-glucose, acetate, calcium magnesium potassium sodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as D-Glucuronic acid,
polymer with 6-deoxy-L-mannose and D-glucose, acetate, calcium
magnesium potassium sodium salt (PMN P-00-7; CAS No.125005-87-0) 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) (oilfield drilling fluid, oilfield
spacer fluid, oilfield cementing, cementitious packaged products,
concrete applications, and foam applications).
(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 chemical substance.
[[Page 70176]]
(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. 721.2098 to subpart E to read as follows:
Sec. 721.2098 Aliphatic polycarboxylic acid metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aliphatic polycarboxylic acid metal salt (PMN P-01-7) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(v)(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 chemical 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. 721.2685 to subpart E to read as follows:
Sec. 721.2685 Polyisobutene epoxide (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polyisobutene epoxide (PMNs P-99-951 and P-99-952) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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 chemical 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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16. By adding new Sec. 721.2752 to subpart E to read as follows:
Sec. 721.2752 Epoxy resin containing phosphorus (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
epoxy resin containing phosphorus (PMN P-00-912) 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 chemical 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. 721.575(b)(1) apply to this section.
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17. By adding new Sec. 721.3062 to subpart E to read as follows:
Sec. 721.3062 Haloarylalkylketoester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
haloarylalkylketoester. (PMN P-00-966) 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).
(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 chemical 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. 721.3110 to subpart E to read as follows:
Sec. 721.3110 Polycarboxylic acid ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polycarboxylic acid ester (PMN P-97-1108) is subject to reporting under
this section for the significant new use described in paragraph (a)(1)
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 chemical substance.
(2) Limitations or evocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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19. By adding new Sec. 721.3130 to subpart E to read as follows:
Sec. 721.3130 Sulfuric acid, mono-C9-11-alkyl esters,
sodium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as sulfuric acid,
mono-C9-11-alkyl esters, sodium salts (PMN P-01-149; CAS No.
84501-49-5) 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(s) (5,000 kilogram (kg)).
(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 chemical 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. 3135 to subpart E to read as follows:
[[Page 70177]]
Sec. 721.3135 Phosphorous modified epoxy resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phosphorous modified epoxy resin (PMNs P-00-992 and P-01-471) 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)(4),
(b)(4), and (c)(4) (N=6).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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21. By adding new Sec. 721.3438 to subpart E to read as follows:
Sec. 721.3438 Chlorohydroxyalkyl butyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
chlorohydroxyalkyl butyl ether (PMN P-99-1295) 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).
(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 chemical 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. 721.3835 to subpart E to read as follows:
Sec. 721.3835 Chloroformate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
chloroformate (PMN P-01-1) 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) Releases to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply 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 chemical 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. 721.4096 to subpart E to read as follows:
Sec. 721.4096 Substituted anilino halobenzamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted anilino halobenzamide (PMN P-99-1288) is subject to
reporting under this section for the significant new use described in
paragraph (a)(1) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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24. By adding new Sec. 721.4258 to subpart E to read as follows:
Sec. 721.4258 Substituted naphthalene hydrazide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted naphthalene hydrazide (PMN P-01-69) 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. Requirement 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
25. By adding new Sec. 721.5252 to subpart E to read as follows:
Sec. 721.5252 2-Naphthalenecarboxylic acid, 4,4'-methylenebis [3-
hydroxy-, zinc salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
Naphthalenecarboxylic acid, 4,4'-methylenebis [3-hydroxy-, zinc salt
(P-99-1342; CAS No. 235083-88-2) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified 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. Record keeping requirements as specified in
Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this chemical 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. 721.5253 to subpart E to read as follows:
Sec. 721.5253 2-Naphthalenecarboxylic acid, 4,4'-methylenebis [3-
hydroxy-, strontium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
Naphthalenecarboxylic acid, 4,4'-methylenebis [3-hydroxy-, strontium
salt (PMN P-99-1341; CAS No. 235083-90-6) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
[[Page 70178]]
(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. Record keeping requirements as specified in
Sec. 721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this chemical 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. 721.5288 to subpart E to read as follows:
Sec. 721.5288 Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-
naphthenyl)azo]-7-nitro-1-substituted][N-[7-hydroxy-8-[(2-hydroxy-5-
nitrophenyl)azo]-1-substituted]-, salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthenyl)azo]-7- nitro-1-
substituted][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-
substituted]-, salt (PMN P-99-783) is subject to reporting under this
section for the significant new use described in paragraph (a)(1) 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 chemical 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. 721.5293 to subpart E to read as follows:
Sec. 721.5293 Poly(oxy-1,2-ethanediyl), alpha-(9Z)-9-
octadecenyl-.omega.-hydroxy-, phosphate, ammonium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), alpha-(9Z)-9-octadecenyl-.omega.-hydroxy-, phosphate,
ammonium salt (PMN P-99-920; CAS No. 58857-49-1) is subject to
reporting under this section for the significant new use described in
paragraph (a)(1) 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 chemical 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. 721.5315 to subpart E to read as follows:
Sec. 721.5315 Nickel, cobalt mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as nickel,
cobalt mixed metal oxide. (PMN P-02-90) 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).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
30. By adding new Sec. 721.5340 to subpart E to read as follows:
Sec. 721.5340 Substituted benzothiazole-azo-substituted
benzoquinoline nickel complex (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzothiazole-azo-substituted benzoquinoline nickel complex
(PMN P-99-897) is subject to reporting under this section for the
significant new use described in paragraph (a)(1) 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 chemical 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. 721.5358 to subpart E to read as follows:
Sec. 721.5358 2-propanol, 1,1',1'-nitrilotris-, compds. with ethanol
2-[2-(C12-14- alkyloxy) ethoxy] derivs. hydrogen sulfates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol,
1,1',1'-nitrilotris-, compds. with ethanol 2-[2-(C12-14-
alkyloxy) ethoxy] derivs. hydrogen sulfates (PMN P-99-928; CAS No.
222975-06-6) 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) (surfactant used in toilet bowl
cleaner).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of 721.185 apply to this section.
0
32. By adding new Sec. 721.5546 to subpart E to read as follows:
Sec. 721.5546 Halogen substituted oxetanes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
halogen substituted oxetanes. (PMNs P-98-1033 through P-98-1035) are
subject to reporting under
[[Page 70179]]
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(ii) Hazard communication program. A significant new use of these
chemical substances is any manner or method of manufacture, import, or
processing associated with any use of these chemical substances without
providing risk notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for these chemical substances, the employer becomes
aware that these chemical substances may present a risk of injury to
human health or the environment, the employer must incorporate this new
information, and any information on methods for protecting against such
risk, into a Material Safety Data Sheet (MSDS) as described in Sec.
721.72(c) within 90 days from the time the employer becomes aware of
the new information. If this chemical substance is not being
manufactured, imported, processed, or used in the employer's workplace,
the employer must add the new information to an MSDS before the
chemical substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive or who
have received the chemical substances from the employer within 5 years
from the date the employer becomes aware of the new information
described in paragraph (a)(2)(i)(A) of this section, are provided an
MSDS as described in Sec. 721.72(c) containing the information
required under paragraph (a)(2)(i)(A) of this section within 90 days
from the time the employer becomes aware of the new information.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (f), (h), and (i) are applicable to
manufacturers, importers, and processors of these chemical substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
33. By adding new Sec. 721.5560 to subpart E to read as follows:
Sec. 721.5560 Formaldehyde, polymer with (chloromethyl) oxirane and
phenol, reaction products with 6H-dibenz[c,e][1,2]oxaphosphorin-6-
oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1)The chemical substance identified as formaldehyde,
polymer with (chloromethyl) oxirane and phenol, reaction products with
6H-dibenz[c,e][1,2]oxaphosphorin-6-oxide. (PMN P-00-991; CAS No.
300371-38-4) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=6).
(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 chemical 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. 721.5713 to subpart E to read as follows:
Sec. 721.5713 Phenol - biphenyl polymer condensate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phenol - biphenyl polymer condensate (PMN P-00-1220) 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 chemical 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. 721.5718 to subpart E to read as follows:
Sec. 721.5718 Phenol, 2,2'-[6-(2,4-dibutoxyphenyl)-1,3,5-triazine-
2,4-diyl]bis[5-butoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2,2'-[6-
(2,4-dibutoxyphenyl)-1,3,5-triazine-2,4-diyl]bis[5-butoxy- (PMN P-01-
71; CAS No. 208343-47-9) 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) 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 chemical 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. 721.5762 to subpart E to read as follows:
Sec. 721.5762 Aromatic aldehyde phenolic resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic aldehyde phenolic resin (PMN P-01-573) 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 '
721.125(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of sect; 721.185 apply to this section.
0
37. By adding new Sec. 721.5905 to subpart E to read as follows:
Sec. 721.5905 Modified phenolic resin (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 70180]]
(1) The chemical substance identified generically as a modified
phenolic resin (PMN P-01-441) 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 chemical 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. 721.5908 to subpart E to read as follows:
Sec. 721.5908 Modified phenolic resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified phenolic resin (PMN P-01-561) 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 chemical 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. 721.5917 to subpart E to read as follows:
Sec. 721.5917 Phenyl azo dye (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phenyl azo dye (PMN P-02-17) 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), 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 chemical 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. 721.5935 to read as follows:
Sec. 721.5935 Alkylated nitroso-phenylenediamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylated nitroso-phenylenediamine (PMN P-00-636) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (a)(3).
(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), (d), and (e) are applicable to manufacturers,
importers, and processors of this chemical 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. 721.6167 to subpart E to read as follows:
Sec. 721.6167 Piperdinium, 1,1-dimethyl-, chloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as piperdinium, 1,1-
dimethyl-, chloride. (PMN P-02-207; CAS No. 24307-26-4) 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) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
0
42. By adding new Sec. 721.7250 to subpart E to read as follows:
Sec. 721.7250 Polyaziridinyl ester of an aliphatic alcohol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polyaziridinyl ester of an aliphatic alcohol (PMN P-01-97) 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 chemical 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. 721.575(b)(1) apply to this section.
0
43. By adding new Sec. 721.7255 to subpart E to read as follows:
Sec. 721.7255 Polyethyleneamine crosslinked with substituted
polyethylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyethyleneamine crosslinked with substituted polyethylene glycol with
substituted polyethylene glycol (PMN P-01-833) is subject to reporting
under this section
[[Page 70181]]
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) (absorbent polymer).
(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 chemical 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. 721.7270 to subpart E to read as follows:
Sec. 721.7270 1-propanaminium, 3-amino-, N, N, N-trimethyl-N-soya
acyl derivs., chloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium, 3-
amino-, N, N, N-trimethyl-N-soya acyl derivs., chloride (PMN P-01-646;
CAS No. 391232-99-8) 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).
(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 chemical 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 apply to this section.
0
45. By adding new Sec. 721.7290 to subpart E to read as follows:
Sec. 721.7290 Propanoic acid, 2-(trimethoxysilyl)-, ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanoic acid, 2-
(trimethoxysilyl)-, ethyl ester (PMN P-01-22; CAS No. 137787-41-8) 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 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(a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this chemical 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. 721.8130 to subpart E to read as follows:
Sec. 721.8130 Propanamide, -(2-hydroxyethyl)-3-methoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanamide, -(2-
hydroxyethyl)-3- methoxy- (PMN P-01-144; CAS No. 35544-45-7) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (organic stripper additive).
(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 chemical 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. 721.8140 to subpart E to read as follows:
Sec. 721.8140 Substituted propane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted propane (PMN P-01-298) 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) (polymer additive).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
48. By adding new Sec. 721.8145 to subpart E to read as follows:
Sec. 721.8145 Propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
propane,1,1,1,2,2,3,3-heptafluoro-3-methoxy- (PMN P-01-320; CAS No.
375-03-1) 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) Industrial, commercial, and consumer activities. Requirements
as specified Sec. 721.80(j) (heating transfer fluid and a refrigerant)
and (s) (100,000 kg)
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
49. By adding new Sec. 721.8340 to subpart E to read as follows:
Sec. 721.8340 Mono esters from 2- propenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mono
esters from 2-propenoic acid (PMN P-01-85) 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 70182]]
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
50. By adding new Sec. 721.8485 to subpart E to read as follows:
Sec. 721.8485 2-Propenoic acid, 2-methyl-, (octahydro-4,7-methano-1H-
indene-5-diyl)bis(methylene) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-methyl-, (octahydro-4,7-methano- 1H- indene-5-diyl)bis(methylene)
ester (PMN P-99-1075; CAS No. 43048-08-4) 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(b)(1) and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of these chemical 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. 721.8940 to subpart E to read as follows:
Sec. 721.8940 Chromate(3-), bis[3-[[6-amino-1,4-dihydro-2-[[[4-[(2-
hydroxy-1-naphthalenyl)azo] phenyl]sulfonyl] amino]-4-(oxo-.kappa.O)-5-
pyrimidinyl]azo-.kappaN1] -4-hydroxy-.kappa.O)-5-
nitrobenzenesulfonato(3-)]-, trisodium.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as chromate(3-),
bis[3-[[6-amino-1,4-dihydro-2-[[[4-[(2-hydroxy-1-naphthalenyl)azo]
phenyl] sulfonyl]amino]-4-(oxo-.kappa.O)-5-pyrimidinyl]azo-.kappaN1] -
4-hydroxy-.kappa.O)-5-nitrobenzenesulfonato(3-)]-, trisodium (PMN P-01-
459; CAS No. 178452-72-7) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
52. By adding new Sec. 721.8950 to subpart E to read as follows:
Sec. 721.8950 Chromate(3-), bis[3-[[6-amino-1,4-dihydro-2-[[[4-[(2-
hydroxy-1-naphthalenyl)azo]phenyl]sulfonyl]amino]-4-(oxo-.kappa.O)-5-
pyrimidinyl]azo-.kappaN1]-4-hydroxy-.kappa.O)-5-
nitrobenzenesulfonato(3-)]-, sodium triethanolamine salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as chromate(3-),
bis[3-[[6-amino-1,4-dihydro-2- [[[4-[(2-hydroxy-1-naphthalenyl)azo]
phenyl]sulfonyl]amino]-4-(oxo-.kappa.O)-5-pyrimidinyl]azo-.kappaN1] -4-
hydroxy-.kappa.O)-5-nitrobenzenesulfonato(3-)]-, sodium triethanolamine
salts. (PMN P-01-460; CAS No. 327177-98-0) 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), 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
53. By adding new Sec. 721.9078 to subpart E to read as follows:
Sec. 721.9078 6-Methoxy-1H-benz[de]isoquinoline-2 [3H]-dione
derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 6-
methoxy-1H-benz[de]isoquinoline-2 [3H]-dione derivative (PMN P-00-1205)
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=30).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
54. By adding new Sec. 721.9079 to subpart E to read as follows:
Sec. 721.9079 Dihydro quinacridone derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dihydro
quinacridone derivative (PMN P-01-397) 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(s) (1,000 kg).
(ii) Release to water. Requirements as specified Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=2).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 70183]]
provisions of Sec. 721.185 apply to this section.
0
55. By adding new Sec. 721.9501 to subpart E to read as follows:
Sec. 721.9501 Silane, triethoxy[3-oxiranylmethoxy)propyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silane,
triethoxy[3-oxiranylmethoxy)propyl]- (PMN P-01-781; CAS No. 2602-34-2)
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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(l).
(ii) Release to water. Requirements as specified Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=10).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
56. By adding new Sec. 721.9506 to subpart E to read as follows:
Sec. 721.9506 Halogenated arylsilane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
halogenated arylsilane (PMN P-01-9) is subject to reporting under this
section for the significant new use described in paragraph (a)(1) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
57. By adding new Sec. 721.9511 to subpart E to read as follows:
Sec. 721.9511 Silicic acid
(H6SiO2O7), magnesium, strontium
salt(1:1:2), dysprosium and europium-doped.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silicic acid
(H6SiO2O7) magnesium, strontium
salt(1:1:2), dysprosium and europium-doped. (PMN P-98-848; CAS
No.181828-07-9) 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(j) (manufacture or import of the chemical
substance where greater than 5% of the chemical substance is below the
10 micron (respirable particles) threshold).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
58. By adding new Sec. 721.9572 to subpart E to read as follows:
Sec. 721.9572 Substituted alkyl sulfonamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkyl sulfonamide (PMN P-00-838) 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).
(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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
59. By adding new Sec. 721.9640 to subpart E to read as follows:
Sec. 721.9640 Salt of an acrylic acid - acrylamide terpolymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as salt of
an acrylic acid - acrylamide terpolymer (PMN P-99-817) 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), 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
60. By adding new Sec. 721.9674 to subpart E to read as follows:
Sec. 721.9674 Sulfonated-copper phthalocyanine salt of a
triarylmethane dye (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated-copper phthalocyanine salt of a triarylmethane dye (PMN P-
00-1055) 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), and (x)(1).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this chemical substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 70184]]
provisions of Sec. 721.185 apply to this section.
0
61. By adding new Sec. 721.9929 to subpart E to read as follows:
Sec. 721.9929 Polyurea (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polyurea (PMN P-01-716) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
62. By adding new Sec. 721.9959 to subpart E to read as follows:
Sec. 721.9959 Polyurethane polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polyurethane polymer (PMN P-01-481) 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 chemical substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
[FR Doc. 03-31121 Filed 12-16-03; 8:45 am]
BILLING CODE 6560-50-S
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