[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Rules and Regulations]
[Pages 354-374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-179]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50635; FRL-6055-2]
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 40
chemical substances which were the subject of premanufacture notices
(PMNs) and subject to TSCA section 5(e) consent orders issued by EPA.
Today's action requires persons who intend to manufacture, import, or
process these substances for a significant new use to notify EPA at
least 90 days before commencing the manufacturing or processing of the
substance for a use designated by this SNUR as a significant new use.
The required notice will provide EPA with the opportunity to evaluate
the intended use, and if necessary, to prohibit or limit that activity
before it occurs to prevent any unreasonable risk of injury to human
health or the environment. EPA is promulgating this SNUR using direct
final procedures.
DATES: The effective date of this rule is March 6, 2000 without further
notice, unless EPA receives adverse comment or notice of intent to
submit adverse comment before February 4, 2000. This rule shall be
promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on
January 19, 2000.
If EPA receives adverse comment or notice before February 4, 2000
that someone wishes to submit adverse or critical comments on EPA's
action in establishing a SNUR for one or more of the chemical
substances subject to this rule, EPA will withdraw the SNUR before the
effective date for the substance for which the comment or notice of
intent to comment is received and will issue a proposed SNUR providing
a 30-day period for public comment.
ADDRESSES: Comments or notice of intent to submit adverse or critical
comments may be submitted by mail, electronically, or in person. Please
follow the detailed instructions for each method as provided in Unit
I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To ensure proper
receipt by EPA, it is imperative that you identify docket control
number OPPTS-50635 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: For general information contact: Joe
Carra, Deputy Director, Office of Pollution Prevention and Toxics
(7401), Environmental Protection Agency, 401 M St., SW., Washington, DC
20460, telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e-
mail address: TSCA-H[email protected].
For technical information contact: James Alwood, Chemical Control
Division (7405), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-435, 401 M St., SW., Washington,
DC 20460, telephone number: (202) 260-1857; e-mail address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this rule.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS Potentially
Affected Entities
------------------------------------------------------------------------
Chemical manufacturers 325 Manufacturers,
importers,
processors, and
users of
chemicals
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Petroleum and coal product 324 Manufacturers,
industries importers,
processors, and
users of
chemicals
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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 the table 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 or not this action applies to certain entities. To
determine whether you or your business is 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 in the ``FOR
FURTHER INFORMATION CONTACT.''
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain copies of this document, and
certain other related documents that might be available electronically,
from the EPA Internet Home Page at http://www.epa.gov/. You may also
obtain copies of the notice of availability documents for the 835 (63
FR 4259, January 28, l998) (FRL-5761-7), 850 (62 FR 16486, April 15,
l996) (FRL-5363-1), and 870 (63 FR 41845, August 5, l998) (FRL-5740-1)
series OPPTS harmonized test guidelines at this same site. To access
these documents, on the Home Page select ``Laws and Regulations'' and
then look up the entry for this document under the ``Federal Register
Environmental Documents.'' You can also go directly to the Federal
Register listings at http://www.epa.gov/fedrgstr/. The OPPTS harmonized
test guidelines referenced in this document are available on EPA's
Internet Home Page at http://www.epa.gov/OPPTS-Harmonized/.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-50635. The official
record consists of the documents specifically referenced in this
action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the TSCA Nonconfidential Information Center, North
East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC.
The Center is open from noon to 4 p.m., Monday through Friday,
excluding legal
[[Page 355]]
holidays. The telephone number for the Center is (202) 260-7099.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPPTS-50635 in the subject line on
the first page of your response.
1. By mail. Submit your comments to: Document Control Office
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: OPPT Document
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M
St., SW., Washington, DC. 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) 260-7093.
3. Electronically. You may submit your comments electronically by
e-mail to: ``[email protected],'' or mail your computer disk to the
address identified above. Do not submit any information electronically
that you consider to be CBI. Electronic comments must be submitted as
an ASCII file avoiding the use of special characters and any form of
encryption. Comments will also be accepted on standard disks in
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by docket control number OPPTS-50635.
Electronic comments may also be filed online at many Federal Depository
Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
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 version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the technical person identified in the ``FOR FURTHER
INFORMATION CONTACT.''
E. What Should I Consider as I Prepare My Comments for EPA?
We invite you to provide your views on the various options we
propose, new approaches we haven't considered, the potential impacts of
the various options (including possible unintended consequences), and
any data or information that you would like the Agency to consider
during the development of the final action. You may find the following
suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the rule.
7. Make sure to submit your comments by the deadline in this
document.
8. To ensure proper receipt by EPA, be sure to identify the docket
control 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?
This SNUR will require persons to notify EPA at least 90 days
before commencing manufacturing, importing, or processing a substance
for any activity designated by this SNUR as a significant new use. The
supporting rationale and background to this rule are more fully set out
in the preamble to EPA's first direct final SNUR published in the
Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble
for further information on the objectives, rationale, and procedures
for the rules and on the basis for significant new use designations
including provisions for developing test data.
B. What is the Agency's Authority for Taking this Action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a significant
new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice
to EPA at least 90 days before they manufacture, import, or process the
substance for that use. The mechanism for reporting under this
requirement is established under 40 CFR 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear under subpart A of 40 CFR part
721. These provisions describe persons subject to the rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. Persons subject to this SNUR must comply with the same notice
requirements and EPA regulatory procedures as submitters of PMNs under
section 5(a)(1)(A) of TSCA. In particular, these requirements include
the information submission requirements of TSCA section 5(b) and
5(d)(1), the exemptions authorized by TSCA section 5 (h)(1), (h)(2),
(h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA
receives a SNUR notice, EPA may take regulatory action under TSCA
section 5(e), 5(f), 6, or 7 to control the activities on which it has
received the SNUR notice. If EPA does not take action, EPA is required
under TSCA section 5(g) to explain in the Federal Register its reasons
for not taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret TSCA section 12(b) appear
at 40 CFR part 707. Persons who intend to import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Such persons must certify that they are in
compliance with SNUR requirements. The EPA policy in support of the
import certification appears at 40 CFR part 707.
III. Substances Subject to this Rule
EPA is establishing significant new use and recordkeeping
requirements for the following chemical substances under 40 CFR part
721, subpart E. In this unit, EPA provides a brief description for each
substance, including its PMN number, chemical name (generic name if the
specific name is claimed as CBI), CAS number (if assigned for non-
confidential chemical
[[Page 356]]
identities), basis for the action taken by EPA in the TSCA section 5(e)
consent order or as a non-section 5(e) SNUR for the substance
(including the statutory citation and specific finding), toxicity
concern, and the CFR citation assigned in the regulatory text section
of this rule. The specific uses which are designated as significant new
uses are cited in the regulatory text section of this document by
reference to 40 CFR part 721, subpart E where the significant new uses
are described in detail. Certain new uses, including production limits
and other uses designated in the rule are claimed as CBI. The procedure
for obtaining confidential information is set out in Unit VII. of this
preamble.
Where the underlying TSCA section 5(e) consent order prohibits the
PMN submitter from exceeding a specified production limit without
performing specific tests to determine the health or environmental
effects of a substance, the tests are described in this unit. As
explained further in Unit VI. of this preamble, the SNUR for such
substances contains the same production limit, and exceeding the
production limit is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a significant new use notice (SNUN) at least 90 days in
advance. In addition, this unit describes tests that are recommended by
EPA to provide sufficient information to evaluate the substance, but
for which no production limit has been established in the TSCA section
5(e) consent order. Descriptions of recommended tests are provided for
informational purposes.
Data on potential exposures or releases of the substances, testing
other than that specified in the TSCA section 5(e) consent order for
the substances, or studies on analogous substances, which may
demonstrate that the significant new uses being reported do not present
an unreasonable risk, may be included with significant new use
notification. Persons submitting a SNUN must comply with the same
notice requirements and EPA regulatory procedures as submitters of
PMNs, as stated in 40 CFR 721.1(c), including submission of test data
on health and environmental effects as described in 40 CFR 720.50.
EPA is not publishing SNURs for PMNs P-97-991, P-97-342/343/344, P-
97-727/728/730/731/732/904, P-98-123, P-98-325, P-98-359, P-98-700/701,
and P-98-796, which are subject to a final TSCA section 5(e) consent
order. The TSCA section 5(e) consent orders for these substances are
derived from an exposure finding based solely on substantial production
volume and significant or substantial human exposure and/or release to
the environment of substantial quantities. For these cases there were
limited or no toxicity data available for the PMN substances. In such
cases, EPA regulates the new chemical substances under TSCA section
5(e) by requiring certain toxicity tests. For instance, chemical
substances with potentially substantial releases to surface waters
would be subject to toxicity testing of aquatic organisms and chemicals
with potentially substantial human exposures would be subject to health
effects testing for mutagenicity, acute effects, and subchronic
effects. However, for these substances, the short-term toxicity testing
required by the TSCA section 5(e) consent order is usually completed
within 1 to 2 years of notice of commencement. 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 notice of
commencement (NOC) or data demonstrating risk are received unless the
toxicity testing required is long-term. EPA is issuing this explanation
and notification as required in 40 CFR 721.160(a)(2) as it has
determined that SNURs are not needed at this time for these substances
which are subject to a final section 5(e) consent order under TSCA.
PMN Number P-90-1527
Chemical name: (generic) Halogenated benzyl ester acrylate.
CAS number: Not available.
Effective date of section 5(e) consent order: July 20, l998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health and the environment.
Toxicity concern: The PMN substance has been shown to cause kidney and
blood effects in test animals. Also, similar chemicals have been shown
to form dibenzodioxins and dibenzofurans when incinerated under
combustion conditions of municipal incinerators.
Recommended testing: A 90-day subchronic oral study in rats (40 CFR
798.2650 or OPPTS 870.3100 test guideline) is required to help
characterize systemic effects observed in shorter term testing. An
incineration simulation study is required to help characterize the
potential for the formation of dibenzodioxins or dibenzofurans when
plastics or resins containing the PMN substance are incinerated. The
consent order contains two production volume limits. The PMN submitter
has agreed not to exceed the first production volume limit without
performing the 90-day subchronic oral study. The PMN submitter has also
agreed not to exceed the second higher production volume limit without
performing an incineration simulation test.
CFR citation: 40 CFR 721.329.
PMN Numbers P-94-697 through P-94-895
Chemical name: (generic) Fatty acids C12-18, C18
unsaturated, C12-18 alkyl esters.
CAS number: Not available.
Effective date of section 5(e) consent order: October 6, 1994.
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 substances are expected to be produced in
substantial quantities, there may be significant or substantial human
exposure to the substances, and the substances may enter the
environment in substantial quantities.
Recommended testing: EPA has determined that a 28-day oral toxicity
study in rats (Organization for Economic Cooperation and Development
(OECD) guideline no. 407) 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 shall be extended to include testes/ovaries
and lungs, and an oral developmental toxicity study in one species (40
CFR 798.4900 or OPPTS 870.3700 test guideline) would help to
characterize the health effects of the substances. EPA has determined
that a ``modified Semicontinuous Activated Sludge (SCAS) test'' (OPPTS
835.3210 test guideline) and a ready biodegradation study (OPPTS
835.3110 test guideline) would help to characterize the environmental
effects of the substances. The PMN submitter has agreed not to exceed
the production volume limit without performing the toxicity studies
using P-94-697 and the biodegradation studies using P-94-697.
CFR citation: 40 CFR 721.3025.
PMN Number P-95-169
Chemical name: Morpholine, 4-(1-oxo-2-propenyl)-.
CAS number: 5117-12-4.
[[Page 357]]
Effective date of section 5(e) consent order: November 27, 1998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to health and the environment.
Toxicity concern: Structurally similar chemicals have been shown to
cause heritable mutagenicity, carcinogenicity, neurotoxicity,
reproductive toxicity, developmental toxicity, and systemic toxicity in
test animals and chronic aquatic toxicity in aquatic organisms.
Recommended testing: The consent order contains four production volume
limits. The PMN submitter has agreed not to exceed the first production
volume limit without performing an OECD guideline no. 422 study
extended to 90 days with observations for motor activity and
neuropathology (NTIS: PB91-154617) within 1 year from the commencement
of commercial manufacture or import to address the systemic,
developmental, and neurotoxic effects. The PMN submitter has also
agreed not to exceed the second higher production volume limit without
performing a rodent dominant lethal assay (40 CFR 798.5450 or OPPTS
870.5450 test guideline) 14 weeks before manufacturing or importing
1,300,000 kilograms of the PMN substance. If the rodent dominant lethal
assay is positive, the PMN submitter has also agreed not to exceed the
third higher production volume limit without performing a rodent
heritable translocation test (40 CFR 798.5460 or OPPTS 870.5460 test
guideline) which would be the appropriate follow-up test and it must be
submitted to EPA 14 weeks before manufacturing or importing 1,600,000
kilograms of the PMN substance or 1 year after the submission of the
rodent dominant lethal assay to EPA, whichever comes later to help
characterize the heritable mutagenic effects. The PMN submitter has
also agreed not to exceed the fourth higher production volume limit
without performing a 2-year, two-species oral carcinogenicity test (40
CFR 798.3300 or OPPTS 870.4200 test guideline) in rats and mice 14
weeks before manufacturing or importing an additional 4,000,000
kilograms of the PMN substance (a total of 5,500,000 kilograms) or 5
years after the commencement of commercial manufacture, whichever comes
later to help characterize the carcinogenic effects.
The following additional information would be required to evaluate
the environmental effects which may be caused by the PMN substance:
daphnid chronic toxicity study (40 CFR 797.1330 or OPPTS 850.1300 test
guideline (public draft)), a fish early life stage toxicity (40 CFR
797.1600 or OPPTS 850.1400 test guideline (public draft)), and a semi-
continuous activated sludge study (OPPTS 835.3210 test guideline). The
order does not require submission of the above information at any
specified time or production volume. However, the order's restrictions
on manufacture, import, processing, distribution in commerce, use, and
disposal of the PMN substance will remain in effect until the order is
modified or revoked by EPA based on submission of that or other
relevant information.
CFR citation: 40 CFR 721.5185.
PMN Numbers P-95-1400 and P-95-1410
Chemical names: (generic) (P-95-1400) Perfluorinatedalkyl
polyhydroxysilane; and (P-95-1410) Perfluorinatedalkyl
polyalkoxysilane.
CAS number: Not available.
Effective date of section 5(e) consent order: May 15, l998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health.
Toxicity concern: Based on submitted acute inhalation toxicity data
with 10 percent formulations of PMN P-95-1400 containing
hexadecyltrimethyl ammonium chloride, and sodium dodecylbenzene
sulfonate as emulsifiers, P-95-1400 has been shown to cause death in
test animals at concentrations as low as 61 milligrams per cubic meter.
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rats (40 CFR 799.9346 or OPPTS 870.3465 test
guideline) would help to characterize a lethality risk to consumers
exposed via inhalation during use of these PMN substances.
CFR citations: 40 CFR 721.9508 (P-95-1400); 40 CFR 721.9509 (P-95-
1410).
PMN Number P-97-482
Chemical name: Fatty acids, C10-13 - branched, vinyl esters.
CAS number: 184785-38-4.
Effective date of section 5(e) consent order: July 31, 1998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health and the environment.
Toxicity concern: Structurally similar chemicals have been shown to
cause developmental and reproductive toxicity, neurotoxicity and cancer
in test animals, and chronic toxicity to aquatic organisms.
Recommended testing: A metabolic hydrolysis test on both the PMN
substance and the structural analogue vinyl acetate, as well as a 90-
day oral subchronic neurotoxicity testing in rats (OPPTS 870.3150 test
guideline), with certain adjuncts to address reproductive toxicity
concerns, will help the Agency to characterize the human health effects
of the PMN substance. The PMN submitter has agreed not to exceed the
production volume limit without performing these studies. The PMN
submitter has submitted testing on the PMN substance to characterize
environmental toxicity concerns.
CFR citation: 40 CFR 721.9965.
PMN Number P-97-635
Chemical name: Boric acid (H3BO3), mixed esters with polyethylene
glycol mono-Bu ether and polyethylene glycol mono Me ether.
CAS number: 183290-62-2.
Basis for action: This PMN substance will be used as a component of a
brake fluid formulation. EPA has identified health concerns for
reproductive and blood toxicity based on data on structurally similar
borons. Since significant worker exposure is unlikely when workers wear
impervious gloves, as described in the PMN, EPA has not determined that
the proposed processing and use of the substance may present an
unreasonable risk. EPA has determined, however, that manufacture,
process, or use of the substance without dermal protection may result
in serious chronic and developmental effects. Also, based on analogy to
boron, EPA is concerned that toxicity to aquatic organisms may occur at
a concentration as low as 300 parts per billion (ppb) of the PMN
substance in surface waters. Since environmental releases are not
expected to exceed 300 ppb as described in the PMN, EPA has not
determined that the proposed processing and use of the substance may
present an unreasonable risk. EPA has determined, however, that any
release of the PMN substance to surface water above 300 ppb may cause
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii)
and (b)(4)(ii).
Recommended testing: EPA has determined that the OECD reproductive
toxicity screen in rats (OECD guideline
[[Page 358]]
no. 421) with special attention to hematology would help to
characterize the human health effects. If this screen is positive for
reproductive toxicity, a reproductive fertility study in rats (40 CFR
799.9380) is recommended. In addition, the following acute aquatic
toxicity tests: algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline
(public draft)); daphnid (40 CFR 797.1300 or OPPTS 850.1010 test
guideline (public)); and fish (40 CFR 797.1400 or OPPTS 850.1075 test
guideline (public draft)) would help to characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.1729.
PMN Number P-97-636
Chemical name: Poly(oxy-1,2-ethanediyl), -butyl--
hydroxy, ester with boric acid (H3BO3).
CAS number: 106008-93-9.
Basis for action: This PMN substance will be used as a component of a
brake fluid formulation. EPA has identified health concerns for
reproductive and blood toxicity based on data on structurally similar
borons. Since significant worker exposure is unlikely when workers wear
impervious gloves, as described in the PMN, EPA has not determined that
the proposed processing and use of the substance may present an
unreasonable risk. EPA has determined, however, that manufacture,
process, or use of the substance without dermal protection may result
in serious chronic and developmental effects. Also, based on analogy to
boron, EPA is concerned that toxicity to aquatic organisms may occur at
a concentration as low as 300 ppb of the PMN substance in surface
waters. Since environmental releases are not expected to exceed 300 ppb
as described in the PMN, EPA has not determined that the proposed
processing and use of the substance may present an unreasonable risk.
EPA has determined, however, that any release of the PMN substance to
surface water above 300 ppb may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the OECD reproductive
toxicity screen in rats (OECD guideline no. 421) with special attention
to hematology would help to characterize the human health effects. If
this screen is positive for reproductive toxicity, a reproductive
fertility study in rats (40 CFR 799.9380) is recommended. In addition,
the following acute aquatic toxicity tests would help to characterize
the environmental effects: algal (40 CFR 797.1050 or OPPTS 850.5400
test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)); and fish (40 CFR 797.1400 or
OPPTS 850.1075 test guideline (public draft)).
CFR citation: 40 CFR 721.1730.
PMN Number P-97-637
Chemical name: Poly(oxy-1,2-ethanediyl), -methyl--
hydroxy, ester with boric acid (H3BO3).
CAS number: 106008-94-0.
Basis for action: This PMN substance will be used as a component of a
brake fluid formulation. EPA has identified health concerns for
reproductive and blood toxicity based on data on structurally similar
borons. Since significant worker exposure is unlikely when workers wear
impervious gloves, as described in the PMN, EPA has not determined that
the proposed processing and use of the substance may present an
unreasonable risk. EPA has determined, however, that manufacture,
process, or use of the substance without dermal protection may result
in serious chronic and developmental effects. Also, based on analogy to
boron, EPA is concerned that toxicity to aquatic organisms may occur at
a concentration as low as 300 ppb of the PMN substance in surface
waters. Since environmental releases are not expected to exceed 300 ppb
as described in the PMN, EPA has not determined that the proposed
processing and use of the substance may present an unreasonable risk.
EPA has determined, however, that any release of the PMN substance to
surface water above 300 ppb may cause significant adverse environmental
effects. Based on this information, the PMN substance meets the concern
criteria at Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the OECD reproductive
toxicity screen in rats (OECD guideline no. 421) with special attention
to hematology would help to characterize the human health effects. If
this screen is positive for reproductive toxicity, a reproductive
fertility study in rats (40 CFR 799.9380) is recommended. In addition,
the following acute aquatic toxicity tests would help to characterize
the environmental effects: algal (40 CFR 797.1050 or OPPTS 850.5400
test guideline (public draft)); daphnid (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)); and fish (40 CFR 797.1400 or
OPPTS 850.1075 test guideline (public draft)).
CFR citation: 40 CFR 721.1731.
PMN Number P-97-648
Chemical name: Benzeneamine, 3,5-Difluoro-.
CAS number: 372-39-4.
Effective date of section 5(e) consent order: May 15, l998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to the environment, and that there may be significant or substantial
human exposure to the PMN substance.
Toxicity concern: Based on test data submitted with the PMN and data on
structurally analogous chemicals (primarily aniline), the substance may
cause neurotoxicity, mutagenicity, carcinogenicity, maternal and
developmental toxicity, and blood effects to workers via both
inhalation and dermal exposure. The substance has been shown to be
acutely toxic and neurotoxic in test animals.
Recommended testing: EPA has determined that a combined repeated dose
90-day study via oral route in rats with histopathology (OECD Testing
Protocol guideline no. 422), an in vitro mouse lymphoma test (40 CFR
799.9530), and an in vivo micronucleus test (40 CFR 799.9539) would
help to characterize the human health effects of the PMN substance. The
PMN submitter has agreed not to exceed the production volume limit in
the consent order without performing these tests. A 2-year oral
carcinogenicity study in rats (40 CFR 799.9420) would also help to
characterize the human health effects of the PMN substance. In
addition, the following acute aquatic toxicity tests would help to
characterize the environmental effects: algal (40 CFR 797.1050 or OPPTS
850.5400 test guideline (public draft)); fish (40 CFR 797.1400 or OPPTS
850.1075 test guideline (public draft)); and daphnid (40 CFR 797.1300
or OPPTS 850.1010 test guideline (public draft)).
CFR citation: 40 CFR 721.1055.
PMN Number P-97-649
Chemical name: Hydrazinecarboxamide, N-(3,5-difluorophenyl-).
CAS number: 167412-23-9.
Effective date of section 5(e) consent order: May 15, l998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A) (ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health.
Toxicity concern: Based on test data submitted with the PMN and data on
structurally analogous chemicals (primarily aniline), the substance may
cause neurotoxicity, mutagenicity, carcinogenicity, maternal and
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developmental toxicity, and blood effects to workers via inhalation
exposure and via dermal exposure when in a solvent.
Recommended testing: EPA has determined that a combined repeated dose
90-day study via oral route in rats with histopathology (OECD Testing
Protocol guideline no. 422) and an in vivo micronucleus test (40 CFR
799.9539) would help to characterize the human health effects of the
PMN substance. The PMN submitter has agreed not to exceed the
production volume limit in the consent order without performing these
tests.
CFR citation: 40 CFR 721.4265.
PMN Number P-97-661
Chemical name: (generic) Alkyl substituted aromatic glycidyl ether.
CAS number: Not available.
Effective date of section 5(e) consent order: August 10, 1998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health and the environment.
Toxicity concern: Based on data on structurally analogous epoxide
chemicals, the substance may cause skin irritation, developmental
toxicity, male reproductive toxicity, mutagenicity, carcinogenicity,
liver and kidney toxicity and environmental toxicity.
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) is
required to help characterize the human health effects of the
substance. The PMN submitter has agreed not to exceed the production
volume limit in the consent order without performing this test. A 2-
year, two-species oral carcinogencity study (40 CFR 799.4200 or OPPTS
870.4200 test guideline) is also recommended to help characterize the
human health effects of the PMN substance. In addition, the following
aquatic toxicity test would help to characterize the environmental
effects: acute algal (40 CFR 797.1050 or OPPTS 850.5400 test guideline
(public draft)); chronic fish (40 CFR 797.1600 or OPPTS 850.1400 test
guideline (public draft)); and chronic daphnid (40 CFR 797.1330 or
OPPTS 850.1300 test guideline (public draft)) would help to
characterize the environmental effects of the substance.
CFR citation: 40 CFR 721.3845.
PMN Number P-98-105
Chemical name: (generic) Cycloaliphatic epoxy resin.
CAS number: Not available.
Effective date of section 5(e) consent order: August 7, l998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(l)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to human health.
Toxicity concern: Structurally similar epoxides have been shown to
cause mutagenicity, carcinogenicity, male reproductive toxicity, lung
toxicity, and skin and lung sensitization in test animals.
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity test in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline) and a chronic/carcinogenicity oral study in rats (40 CFR
798.3320) would help to characterize the health effects of the PMN
substance. The PMN submitter has agreed not to exceed the production
volume limit without performing the 90-day test.
CFR citation: 40 CFR 721.2755
PMN Number P-98-150
Chemical name: Poly[oxy(methyl-1,2-ethanediyl)],-(1-oxo-2-
propenyl)--[(tetrahydro-2furanyl)methoxy]-.
CAS number: 149303-87-7.
Effective date of section 5(e) consent order: July 13, 1998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and section 5(e)(1)(A)(ii)(I) of TSCA based on a
finding that this substance may present an unreasonable risk of injury
to the environment.
Toxicity concern: Based on structural analogy to acrylates/
methacrylates, EPA expects toxicity to aquatic organisms to occur at a
concentration as low as 1 ppb when the average number of moles of the
propoxy group is 12-14, as low as 20 ppb when the average number of
moles of the propoxy group is 5, and as low as 40 ppb when the average
number of moles of the propoxy group is equal to 2.
Recommended testing: EPA has determined that the results of the
following acute aquatic toxicity tests: algal (40 CFR 797.1050 or OPPTS
850.5400 test guideline (public draft)); daphnid (40 CFR 797.1300 or
OPPTS 850.1010 test guideline (public draft)); and fish (40 CFR
797.1400 or OPPTS 850.1075 test guideline (public draft)) would help to
characterize possible environmental effects of the substance when the
average number of moles of the propoxy group is between 5 and 14.
CFR citation: 40 CFR 721.3310.
PMN Numbers P-98-315/316/317/318
Chemical names: (P-98-315) Bicyclo[2.2.1]hept-2-ene, 5-butyl-; (P-98-
316) Bicyclo[2.2.1]hept-2-ene, 5-hexyl-; (P-98-317) Bicyclo[2.2.1]hept-
2-ene, 5-octyl-; (P-98-318) Bicyclo[2.2.1]hept-2-ene, 5-decyl-.
CAS numbers: 22094-81-1, 22094-83-3, 22094-84-4, and 22094-85-5.
Basis for action: The PMN substances will be used as monomers for
specialty polymers. Based on structural analogy to neutral organics,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb. Since significant environmental exposure
is unlikely as the substances are not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substances may present an
unreasonable risk. EPA has determined, however, that other uses of the
substances resulting in releases to surface waters may cause
significant adverse environmental effects. Based on this information
the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substances.
CFR citations: 40 CFR 721.4105 (P-98-315); 40 CFR 721.4106 (P-98-316);
40 CFR 721.4107 (P-98-317); 40 CFR 721.4108 (P-98-318).
PMN Number P-98-400
Chemical name: Amines, C12-14-tert-alkyl, sulfonates.
CAS number: 197527-19-8.
Basis for action: The PMN substance will be used as an extreme pressure
lubricant additive in metalworking fluids. Based on structural analogy
to aliphatic amines, 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 unlikely as the substance is not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in releases to surface waters may cause significant
adverse environmental effects. Based on this information the PMN
substance meets
[[Page 360]]
the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.644.
PMN Number P-98-475
Chemical name: Benzenesulfonic acid, 2,2'-[(1E)-1,2- ethenediyl] bis[5-
[[4-(methylamino)-6-[[4-[(methylamino)carbonyl]phenyl]amino]-1,3,5-
triazin-2-yl]amino]-,disodium salt.
CAS number: 180850-95-7.
Effective date of section 5(e) consent order: June 27, 1998.
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), and section
5(e)(1)(A)(ii) of TSCA based on a finding that this substance may
present an unreasonable risk of injury to human health, that the PMN
substance will be produced in substantial quantities, and there may be
significant or substantial human exposure to the substance.
Toxicity concern: Test data on structurally similar chemicals have been
shown to cause reproductive and developmental effects in test animals.
Recommended testing: EPA has determined that an oral developmental
toxicity test in rabbits (40 CFR 799.9370) would help to characterize
the human health effects. The PMN submitter has agreed not to exceed
the production volume limit without performing this test.
CFR citation: 40 CFR 721.9785.
PMN Number P-98-604
Chemical name: (generic) Modified magnesium silicate polymer.
CAS number: Not available.
Basis for action: This PMN substance will be used as an additive in a
polymer. EPA has identified health concerns for lung toxicity/fibrosis
and cancer based on data on structurally similar compounds. Since
significant inhalation exposure is unlikely because there is no
inhalation exposures for the uses described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance in a powdered form may cause
serious chronic effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation toxicity test (40 CFR 798.2450) and a 2-year, two-species
inhalation carcinogenicity study (40 CFR 799.9420) would help to
characterize the human health effects.
CFR citation: 40 CFR 721.9513.
PMN Number P-98-645
Chemical name: (generic) Substituted perfluoroalkyl sulfonamide.
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymer additive.
Based on structural analogy to nonionic surfactants, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 4 ppb of the PMN substance in surface waters. Since significant
environmental exposure is unlikely as the substance is not released to
surface waters, as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the substance resulting in releases to surface waters may cause
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.9573.
PMN Number P-98-679
Chemical name: (generic) Alkylbenzenesulfonic acid.
CAS number: Not available.
Basis for action: The PMN substance will be used as an extreme pressure
lubricant additive in metalworking fluids. Based on structural analogy
to aliphatic amines, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 2 ppb of the PMN
substance in surface waters. Since significant environmental exposure
is unlikely as the substance is not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substance may present an
unreasonable risk. EPA has determined, however, that other uses of the
substance resulting in releases to surface waters may cause significant
adverse environmental effects. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.1655.
PMN Number P-98-716
Chemical name: Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-
[bis(2hydroxypropyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-
yl]amino]-, disodium salt, compd. with 2,2',2''-nitrilotris[ethanol]
(1:2); Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-[(3-
sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[bis(2-
hydroxypropyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-
yl]amino]-2-sulfophenyl]ethenyl]-disodium salt-, compd.with 2,2',2''-
nitrilotris[ethanol] (1:2).
CAS numbers: 198716-46-0 and 198716-48-2.
Basis for action: The PMN substance will be used as a textile whitening
agent. Based on toxicity data for structurally similar substances, EPA
has identified health concerns for developmental toxicity. Since
significant worker exposure is unlikely because it would not be
manufactured, processed, or used as a powder or solid, EPA has not
determined that manufacturing, processing, or use of the substance as
described in the PMN may present an unreasonable risk. EPA has
determined, however, that manufacturing, processing, or use of the
substance as a solid or powder may cause serious developmentally toxic
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 by the oral route in two-species (40 CFR 799.9370) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9790.
[[Page 361]]
PMN Number P-98-718
Chemical name: (generic) Mixed alkyl phenolic novolak resin.
CAS number: Not available.
Basis for action: The PMN substance will be used as a raw material in
the manufacture of photoresist. Based on structural analogy to
polyphenols, EPA is concerned that toxicity to aquatic organisms may
occur at a concentration as low as 4 ppb of the PMN substance in
surface waters. Since significant environmental exposure is unlikely as
the substance is not released to surface waters, as described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in releases to surface waters may cause significant adverse
environmental effects. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.5380.
PMN Number P-98-725
Chemical name: Amides, tall-oil fatty, N-[2-[2-
hydroxyethyl)amino]ethyl], reaction products with sulfur dioxide; Fatty
acids, tall-oil, reaction products with 1-piperazineethanamine and
sulfur dioxide; and Fatty acids, tall-oil reaction products with sulfur
dioxide and triethylenetetramine.
CAS numbers: 202483-48-5, 203809-20-5, and 204401-83-2.
Basis for action: The PMN substance will be used as a corrosion
inhibitor for oil and gas production and pipelines. Based on structural
analogy to amphoteric surfactants, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 4 ppb of the
PMN substance in surface waters. Since significant environmental
exposure is unlikely as the substance is not released to surface
waters, as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the substance resulting in releases to surface waters may cause
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.9672.
PMN Number P-98-774
Chemical name: (generic) Benzenesulfonic acid, 2,2'-(1,2-
ethenediyl)bis[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-, disodium salt;
substituted with dialkyl amines.
CAS number: Not available.
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on toxicity data on structurally similar
substances, EPA has identified health concerns for developmental
toxicity. Since significant worker exposure is unlikely because it
would not be manufactured, processed, or used as a powder, EPA has not
determined that manufacturing, processing, or use of the substance as
described in the PMN may present an unreasonable risk. EPA has
determined, however, that manufacturing, processing, or use of the
substance as a powder may cause serious developmentally toxic 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 by the oral route in two-species (40 CFR 799.9370) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9795.
PMN Number P-98-807
Chemical name: (generic) Alkoxylated acrylate polymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as a formulation
component for Ultra Violet (UV) curable photo polymer, a formulation
component for UV curable coatings and a chemical intermediate. Based on
an analogy to acrylates, 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 unlikely as the substance is not released to surface waters
resulting in concentrations greater than 10 ppb, as described in the
PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that other uses of the substance resulting
in releases to surface waters greater than 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 (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.324.
PMN Numbers P-98-843 and P-86-65
Chemical name: (generic) Phenyl, alkyl, hydroxyalkyl substituted
imidazole.
CAS number: Not available.
Basis for action: The PMN substance will be used as a curing agent in
the manufacture of liquid epoxy adhesive. EPA has a concern for
neurotoxicity based on structural analogy to methylimidiazoles and a
concern for irritation to mucous membranes and eyes based on structural
analogy to imidazole. Since significant worker exposure is unlikely
when workers wear respiratory equipment, as described in the PMN, EPA
has not determined that the proposed manufacturing, processing, and use
of the substance may present an unreasonable risk. EPA has determined,
however, that use of the substance without respiratory protection could
result in exposures that may cause serious chronic effects.
Additionally, based on analogy to aliphatic amines, EPA is also
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 9 ppb of the PMN substance in surface waters.
Since significant environmental exposure is unlikely as the substance
is not released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in releases to
surface waters may cause significant adverse environmental effects.
Based on this
[[Page 362]]
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that an acute oral study in
rats (OPPTS 870.1100 test guideline) and a 90-day subchronic oral study
in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline) would help
to characterize the health effects of the PMN substance. The PMN
submitter has agreed not to exceed the production volume limit in the
consent order without conducting these tests. EPA has also determined
that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075
test guideline (public draft)), a daphnid acute toxicity study (40 CFR
797.1300 or OPPTS 850.1010 test guideline (public draft)), and an algal
acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline
(public draft)) would help to characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.4472.
PMN Number P-98-1036
Chemical name: Hydrofluoric acid, reaction products with heptane.
CAS number: 207409-71-0.
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on toxicity data on structurally similar
substances, EPA has identified health concerns for developmental
toxicity, cardiosensitization, reproductive toxicity in males,
neurotoxicity, and liver toxicity. Since significant worker exposure is
unlikely when the substance is used as an intermediate, as described in
the PMN, EPA has not determined that the proposed manufacturing,
processing, and use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance other than as an
intermediate could result in exposures which may cause serious chronic
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 by the oral route in two-species (40 CFR 799.9370) would
help to characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.4385.
PMN Number P-98-1043
Chemical name: (generic) Substituted amino alkyl triazinyl
benzenesulfonic acid derivative.
CAS number: Not available.
Basis for action: This PMN substance will be used as an additive in a
polymer. EPA has identified health concerns for lung toxicity/fibrosis
and cancer based on data on structurally similar compounds. Since
significant worker exposure is unlikely when the substance is processed
and used as described in the PMN, EPA has not determined that the
proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that
domestic manfacture of the substance could result in exposures which
may cause serious chronic effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(1)(i)(C).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation toxicity test (40 CFR 798.2450 or OPPTS 870.3465 test
guideline) and a 2-year, two-species inhalation carcinogenicity study
(40 CFR 798.3300 or OPPTS 870.4200 test guideline) would help to
characterize the human health effects.
CFR citation: 40 CFR 721.9810.
PMN Numbers P-98-1046/1047
Chemical name: (generic) Fluoroalkyl diester.
CAS number: Not available.
Basis for action: These PMN substances will be used as site limited
intermediates in the production of a fluorinated compound. Based on
structural analogy to esters, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 200 ppb of the PMN
substances in surface waters. Since significant environmental exposure
is unlikely as the substances are not released to surface waters, as
described in the PMN, EPA has not determined that the proposed
manufacturing, processing, and use of the substances may present an
unreasonable risk. EPA has determined, however, that other uses of the
substances resulting in releases to surface waters may cause
significant adverse environmental effects. Based on this information
the PMN substances meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substances.
CFR citation: 40 CFR 721.2385.
PMN Number P-98-1048
Chemical name: 3-furancarboxaldehyde, tetrahydro-.
CAS number: 79710-86-4.
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on toxicity data on structurally similar
substances, EPA has identified health concerns for immunotoxicity,
carcinogenicity, neurotoxicity, male reproductive toxicity, and
corrosion to eyes, lung, and mucous membranes. Since significant worker
exposure is unlikely when the substance is manufactured, processed, and
used as an intermediate as described in the PMN, EPA has not determined
that the proposed manufacturing, processing, and use of the substance
may present an unreasonable risk. EPA has determined, however, that use
of the substance other than as intermediate could result in exposures
which may cause serious chronic effects. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and
(b)(1)(i)(C).
Recommended testing: EPA has determined that a prenatal developmental
toxicity study by the oral route in two-species (40 CFR 798.4900 or
OPPTS 870.3700 test guideline) would help to characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.2087.
PMN Number P-98-1162
Chemical name: 1,3-Benzenedicarboxylic acid, bis[[4-
[(ethenyloxy)methyl] cyclohexyl] methyl] ester.
CAS number: 119581-93-0.
Basis for action: The PMN substance will be used as a radiation curable
coating, ink, and adhesives. 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 unlikely as the substance
is not released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in releases to
surface waters may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a
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daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test
guideline (public draft)), and an algal acute toxicity study (40 CFR
797.1050 or OPPTS 850.5400 test guideline (public draft)) would help to
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.1576.
PMN Number P-98-1163
Chemical name: 1,4-Benzenedicarboxylic acid, bis[4-(ethenyloxy) butyl]
ester.
CAS number: 117397-31-6.
Basis for action: The PMN substance will be used as a radiation curable
coating, ink, and adhesives. Based on structural analogy to esters, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 30 ppb of the PMN substance in surface waters.
Since significant environmental exposure is unlikely as the substance
is not released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in releases to
surface waters may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.1577.
PMN Number P-98-1164
Chemical name: 1,4-Benzenedicarboxylic acid, bis[[4-
[(ethenyloxy)methyl] cyclohexyl] methyl] ester.
CAS number: 209072-72-0.
Basis for action: The PMN substance will be used as a radiation curable
coating, ink, and adhesives. 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 unlikely as the substance
is not released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in releases to
surface waters may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.1578.
PMN Number P-98-1165
Chemical name: 1,2,4-Benzenetricarboxylic acid, tris [4-(ethenyloxy)
butyl] ester.
CAS number: 196109-17-8.
Basis for action: The PMN substance will be used as a radiation curable
coating, ink, and adhesives. Based on structural analogy to esters, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 50 ppb of the PMN substance in surface waters.
Since significant environmental exposure is unlikely as the substance
is not released to surface waters, as described in the PMN, EPA has not
determined that the proposed manufacturing, processing, and use of the
substance may present an unreasonable risk. EPA has determined,
however, that other uses of the substance resulting in releases to
surface waters may cause significant adverse environmental effects.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.1579.
PMN Number P-98-1172
Chemical name: (generic) Amine salt of organic acid.
CAS number: Not available.
Basis for action: This PMN substance will be used as a stabilizer for
polymerization. Based on structural analogy to esters, 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 unlikely as the substance is not released to
surface waters, as described in the PMN, EPA has not determined that
the proposed manufacturing, processing, and use of the substance may
present an unreasonable risk. EPA has determined, however, that other
uses of the substance resulting in releases to surface waters may cause
significant adverse environmental effects. Based on this information
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public
draft)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft))
would help to characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.5465.
PMN Number P-98-1222
Chemical name: (generic) Benzenesulfonic acid, 2,2'-(1,2-
ethanediyl)bis[5-[[4-substituted-6-substituted-1,3,5-triazin-2-
yl]amino]-, sodium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a fluorescent
brightener in cellulosic paper applications. Based on submitted test
data and analogy to structurally similar substances, EPA has identified
health concerns for kidney effects and developmental toxicity. Since
significant worker exposure is unlikely as the substance is not
manufactured, processed, or used as a powder or a solid, as described
in the PMN, EPA has not determined that the proposed manufacture,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that use of the substance as a powder or
solid could result in inhalation exposures that may cause serious
chronic and developmentally toxic 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 by the oral route in two-species (40 CFR 799.9370)
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would help to characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.9798.
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 11 of the 40
substances, regulation was warranted under section 5(e) of TSCA,
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the substances.
The basis for such findings is outlined in Unit III. of this preamble.
Based on these findings, TSCA section 5(e) consent orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters; the SNUR provisions for these substances designated herein
are consistent with the provisions of the TSCA section 5(e) consent
orders.
In the other 29 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
substance occurs.
4. All manufacturers, importers, and processors of the same
chemical substance which is subject to a TSCA section 5(e) consent
order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the substance is listed on the TSCA Inventory. Manufacturers,
importers, and processors are responsible for ensuring that a new
chemical substance subject to a final SNUR is listed on the TSCA
Inventory.
V. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR
721.160(c)(3)(ii), this rule will be effective March 6, 2000, unless
EPA receives a written notice before February 4, 2000 that someone
wishes to make adverse or critical comments on EPA's action. If EPA
receives such a notice, EPA will publish a document to withdraw the
direct final SNUR for the specific substance to which the adverse or
critical comments apply. EPA will then propose a SNUR for the specific
substance providing a 30-day comment period.
This action establishes SNURs for a number of chemical substances.
Any person who submits a notice of intent to submit adverse or critical
comments must identify the substance and the new use to which it
applies. EPA will not withdraw a SNUR for a substance not identified in
a notice.
VI. Test Data and Other Information
EPA recognizes that section 5 of TSCA does not require developing
any particular test data before submission of a SNUN. Persons are
required only to submit test data in their possession or control and to
describe any other data known to or reasonably ascertainable by them.
In cases where a TSCA section 5(e) consent order requires or recommends
certain testing, Unit III. of this preamble lists those recommended
tests.
However, EPA has established production limits in the TSCA section
5(e) consent orders for several of the substances regulated under this
rule, in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the substances. These production limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these substances. Under recent consent orders, each PMN
submitter is required to submit each study at least 14 weeks (earlier
consent orders required submissions at least 12 weeks) before reaching
the specified production limit. Listings of the tests specified in the
TSCA section 5(e) consent orders are included in Unit III. of this
preamble. The SNURs contain the same production volume limits as the
consent orders. Exceeding these production limits is defined as a
significant new use.
The recommended studies may not be the only means of addressing the
potential risks of the substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under TSCA section 5(e), particularly if
satisfactory test results have not been obtained from a prior
submitter. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on:
1. Human exposure and environmental release that may result from
the significant new use of the chemical substances.
2. Potential benefits of the substances.
3. Information on risks posed by the substances compared to risks
posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule some significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2. EPA is required to keep this information
confidential to protect the CBI of the original PMN submitter. EPA
promulgated a procedure to deal with the situation where a specific
significant new use is CBI. This procedure appears in 40 CFR
721.1725(b)(1) and is similar to that in Sec. 721.11 for situations
where the chemical identity of the substance subject to a SNUR is CBI.
This procedure is cross-referenced in each of these SNURs.
A manufacturer or importer may request EPA to determine whether a
proposed use would be a significant new use under this rule. Under the
procedure incorporated from Sec. 721.1725(b)(1), a manufacturer or
importer must show that it has a bona fide intent to manufacture or
import the substance and must identify the specific use for which it
intends to manufacture or import the substance. If EPA concludes that
the person has shown a bona fide intent to manufacture or import the
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in Sec. 721.1725(b)(1) with
that under Sec. 721.11 into a single step.
If a manufacturer or importer is told that the production volume
identified in the bona fide submission would not be a significant new
use, i.e. it is below the level that would be a significant new use,
that person can manufacture or import the substance as long as the
aggregate amount does not exceed that
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identified in the bona fide submission to EPA. If the person later
intends to exceed that volume, a new bona fide submission would be
necessary to determine whether that higher volume would be a
significant new use. EPA is considering whether to adopt a special
procedure for use when CBI production volume is designated as a
significant new use. Under such a procedure, a person showing a bona
fide intent to manufacture or import the substance, under the procedure
described in Sec. 721.11, would automatically be informed of the
production volume that would be a significant new use. Thus, the person
would not have to make multiple bona fide submissions to EPA for the
same substance to remain in compliance with the SNUR, as could be the
case under the procedures in Sec. 721.1725(b)(1).
VIII. Applicability of Rule to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. TSCA section 5(e) consent
orders have been issued for 12 substances and notice submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received an NOC and the substance has not been added
to the Inventory, no other person may commence such activities without
first submitting a PMN. For substances for which an NOC has not been
submitted at this time, EPA has concluded that the uses are not
ongoing. However, EPA recognizes in cases when chemical substances
identified in this SNUR are added to the Inventory prior to the
effective date of the rule, the substances may be manufactured,
imported, or processed by other persons for a significant new use as
defined in this rule before the effective date of the rule. However, 18
of the 41 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 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new use as of the
date of publication rather than as of the effective date of the rule.
Thus, persons who begin commercial manufacture, import, or processing
of the substances regulated through this SNUR will have to cease any
such activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of the substance between publication and the effective date
of the SNUR do not meet the conditions of advance compliance, they must
cease that activity before the effective date of the rule. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing significant
new use notice requirements for potential manufacturers, importers, and
processors of the chemical substance subject to this rule. EPA's
complete economic analysis is available in the official record for this
rule (OPPTS-50635).
X. Regulatory Assessment Requirements
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 SNURs are not a ``significant
regulatory action'' subject to review by OMB, because SNURs do not meet
the criteria in section 3(f) of the Executive Order.
Based on EPA's experience with past 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) (Pub. L.
104-4).
Similarly, this action is not subject to the requirement for prior
consultation with Indian tribal governments as specified in Executive
Order 13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998). Nor will this action 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).
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).
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.
This action does not involve special considerations of
environmental justice related issues as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
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.
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), Pub. L. 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency has determined that the promulgation
of a SNUR does not have a significant economic impact on a substantial
number of small entities. The Agency's generic certification for the
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promulgation of new SNURs appears on June 2, l997 (62 FR 29684) (FRL-
5597-1) and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
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, after initial display in the preamble of the final rule
and in addition to its display on any related collection instrument,
are listed in 40 CFR part 9.
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
significant new use notice 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 significant new use notice.
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, OP
Regulatory Information Division, Environmental Protection Agency (Mail
Code 2137), 401 M St., SW., Washington, DC 20460. Please remember to
include the OMB control number in any correspondence, but do not submit
any completed forms to this address.
XI. Submission to Congress and the Comptroller General
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 rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this 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 rule in the Federal Register. This 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 20, 1999.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By adding new Sec. 721.324 to subpart E to read as follows:
Sec. 721.324 Alkoxylated acrylate polymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkoxylated acrylate polymer (PMN P-98-807) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
3. By adding new Sec. 721.329 to subpart E to read as follows:
Sec. 721.329 Halogenated benzyl ester acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
halogenated benzyl ester acrylate (PMN P-90-1527) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (b), and (c) (concentration set at 1.0 percent). The
reporting requirement for Sec. 721.63(a)(5)(i) applies only during
manufacture. The reporting requirement for Sec. 721.63 (a)(5)(ii),
(a)(5)(iv), and (a)(5)(v) applies only during processing.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g), (g)(1)(iv), (g)(2)(ii), (g)(2)(iv), and (g)(5). The following
statement shall appear on each label as specified in Sec. 721.72(b) and
the Material Safety Data Sheet (MSDS) as specified in Sec. 721.72 (c):
The substance may cause internal organ effects (kidney and blood). The
requirements of this section do not apply when the PMN substance is
bound or embedded into a plastic, resin matrix, or pellet.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance as specified in Sec. 721.125 (a), (b), (c), (d), (f), (g),
(h), and (i).
(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.
4. By adding new Sec. 721.644 to subpart E to read as follows:
Sec. 721.644 Amines, C12-14-tert-alkyl, sulfonates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amines,
C12-14-tert-alkyl, sulfonates (PMN P-98-400; CAS No. 197527-
19-8) is subject to reporting under this section for the significant
new use described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 367]]
provisions of Sec. 721.185 apply to this section.
5. By adding new Sec. 721.1055 to subpart E to read as follows:
Sec. 721.1055 Benzeneamine, 3,5-difluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzeneamine, 3,5-
difluoro- (PMN P-97-648; CAS No. 372-39-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i),
(a)(6)(v), (b) (concentration set at 0.1 percent), 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 substance. This NCEL is set at 0.4 mg/
m3.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(vii), (g)(1)(ix),
(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i),
(g)(3)(ii), (g)(4)(iii), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g) and (q).
(iv) 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. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance, as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f),
(g), (h), (i) and (k).
(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.
6. By adding new Sec. 721.1576 to subpart E to read as follows:
Sec. 721.1576 1,3-Benzenedicarboxylic acid, bis[[4-
[(ethenyloxy)methyl] cyclohexyl] methyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-
benzenedicarboxylic acid, bis[[4-[(ethenyloxy)methyl] cyclohexyl]
methyl] ester (PMN P-98-1162; CAS No. 119581-93-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
7. By adding new Sec. 721.1577 to subpart E to read as follows:
Sec. 721.1577 1,4-Benzenedicarboxylic acid, bis [4-(ethenyloxy)
butyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, bis[4-(ethenyloxy) butyl] ester (PMN P-98-
1163; CAS No. 117397-31-6) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
8. By adding new Sec. 721.1578 to subpart E to read as follows:
Sec. 721.1578 1,4-Benzenedicarboxylic acid, bis[[4-
[(ethenyloxy)methyl] cyclohexyl] methyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,4-
benzenedicarboxylic acid, bis[[4-[(ethenyloxy)methyl] cyclohexyl]
methyl] ester (PMN P-98-1164; CAS No. 209072-72-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
9. By adding new Sec. 721.1579 to subpart E to read as follows:
Sec. 721.1579 1,2,4-Benzenetricarboxylic acid, tris [4-(ethenyloxy)
butyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,4-
benzenetricarboxylic acid, tris [4-(ethenyloxy) butyl] ester (PMN P-98-
1165; CAS No. 196109-17-8) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
10. By adding new Sec. 721.1655 to subpart E to read as follows:
Sec. 721.1655 Alkylbenzenesulfonic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylbenzenesulfonic acid (PMN P-98-679) is subject to reporting under
this section for the significant new use described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 368]]
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
11. By adding new Sec. 721.1729 to subpart E to read as follows:
Sec. 721.1729 Boric acid (H3BO3), mixed esters with polyethylene
glycol mono-Bu ether and polyethylene glycol mono Me ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as boric acid (H3BO3),
mixed esters with polyethylene glycol mono-Bu ether and polyethylene
glycol mono Me ether (PMN P-97-635; CAS No. 183290-62-2) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i) and (a)(3).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=300).
(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 (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
12. By adding new Sec. 721.1730 to subpart E to read as follows:
Sec. 721.1730 Poly(oxy-1,2-ethanediyl), -butyl--
hydroxy, ester with boric acid (H3BO3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), -butyl--hydroxy, ester with boric acid
(H3BO3) (PMN P-97-636; CAS No. 106008-93-9) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i) and (a)(3).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=300).
(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 (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
13. By adding new Sec. 721.1731 to subpart E to read as follows:
Sec. 721.1731 Poly(oxy-1,2-ethanediyl), -methyl--
hydroxy, ester with boric acid (H3BO3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), -methyl--hydroxy, ester with boric acid
(H3BO3) (PMN P-97-637; CAS No. 106008-94-0) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i) and (a)(3).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=300).
(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 (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
14. By adding new Sec. 721.2087 to subpart E to read as follows:
Sec. 721.2087 3-furancarboxaldehyde, tetrahydro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a 3-
furancarboxaldehyde, tetrahydro- (PMN P-98-1048; CAS No. 79710-86-4) 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(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
15. By adding new Sec. 721.2385 to subpart E to read as follows:
Sec. 721.2385 Fluoroalkyl diester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkyl diester (PMNs P-98-1046 and P-98-1047) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
16. By adding new Sec. 721.2755 to subpart E to read as follows:
Sec. 721.2755 Cycloaliphatic epoxy resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cycloaliphatic epoxy resin (PMN P-98-105) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5)(iii),
(a)(5)(viii), (a)(5)(ix), (a)(5)(x), (a)(6)(ii), (b) (concentration set
at 0.1 percent), and (c). As an alternative to the respiratory
requirements listed here, a manufacturer, importer, or processor may
choose to follow the NCEL provisions listed in the TSCA section 5(e)
consent order for this substance. The NCEL is 0.3 mg/m3.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent),
(f), (g)(1)(vi), (g)(1)(vii),
[[Page 369]]
(g)(2)(i), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
17. By adding new Sec. 721.3025 to subpart E to read as follows:
Sec. 721.3025 Fatty acids C12-18, C18
unsaturated, C12-18 alkyl esters (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids C12-18, C18 unsaturated, C12-18
alkyl esters (PMNs P-94-697 through P-94-895) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (750,000 kilograms).
(ii) Hazard communication program. A significant new use of these
substances is any manner or method of manufacture, import, or
processing associated with any use of these 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 substances, the employer becomes aware
that these 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
an MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If this 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 substances are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive or who
have received the 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), are provided an MSDS as described in
Sec. 721.72(c) containing the information required under paragraph
(a)(2)(i)(A) 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), and (i) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
18. By adding new Sec. 721.3310 to subpart E to read as follows:
Sec. 721.3310 Poly[oxy(methyl-1,2-ethanediyl)],-(1-oxo-2-
propenyl)--[(tetrahydro-2-furanyl)methoxy]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly[oxy(methyl-
1,2-ethanediyl)],-(1-oxo-2-propenyl)--[(tetrahydro-
2-furanyl)methoxy]- (PMN P-98-150; CAS No.149303-87-7) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. Manufacture of the PMN substance with an
average number of moles of propoxy group between 5 and 14.
(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) and (i) are applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
19. By adding new Sec. 721.3845 to subpart E to read as follows:
Sec. 721.3845 Alkyl substituted aromatic glycidyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
substituted aromatic glycidyl ether (PMN P-97-661) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1) and (a)(3).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(iv), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix),
(g)(2)(i), (g)(2)(v), (g) (4) (iii), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c),(d),(e), (f), (g), (h),(i), and (k) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
20. By adding new Sec. 721.4105 to subpart E to read as follows:
Sec. 721.4105 Bicyclo[2.2.1]hept-2-ene, 5-butyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept-
2-ene, 5-butyl- (PMN P-98-315; CAS No. 22094-81-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
21. By adding new Sec. 721.4106 to subpart E to read as follows:
[[Page 370]]
Sec. 721.4106 Bicyclo[2.2.1]hept-2-ene, 5-hexyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept-
2-ene, 5-hexyl- (PMN P-98-316; CAS No. 22094-83-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
22. By adding new Sec. 721.4107 to subpart E to read as follows:
Sec. 721.4107 Bicyclo[2.2.1]hept-2-ene, 5-octyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Bicyclo[2.2.1]hept-
2-ene, 5-octyl- (PMN P-98-317; CAS No. 22094-84-4) 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)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
23. By adding new Sec. 721.4108 to subpart E to read as follows:
Sec. 721.4108 Bicyclo[2.2.1]hept-2-ene, 5-decyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified Bicyclo[2.2.1]hept-2-
ene, 5-decyl- (PMN P-98-318; CAS No. 22094-85-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
24. By adding new Sec. 721.4265 to subpart E to read as follows:
Sec. 721.4265 Hydrazinecarboxamide, N-(3,5-difluorophenyl-).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
hydrazinecarboxamide, N-(3,5-difluorophenyl-) (PMN P-97-649; CAS No.
167412-23-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1) (applies only when the substance is in a solution),
(a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(v), (b) (concentration set at 0.1
percent), and (c). As an alternative to the respiratory requirements
listed here, a manufacturer, importer, or processor may choose to
follow the NCEL provisions listed in the TSCA section 5(e) consent
order for this substance. The NCEL is set at 0.4 mg/m3.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vii),
(g)(1)(ix), (g)(2)(i) (applies only when the substance is in a
solvent), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v) (applies only
when the substance is in a solvent), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g) and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
25. By adding new Sec. 721.4385 to subpart E to read as follows:
Sec. 721.4385 Hydrofluoric acid, reaction products with heptane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a hydrofluoric
acid, reaction products with heptane (PMN P-98-1036; CAS No. 207409-71-
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(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
26. By adding new Sec. 721.4472 to subpart E to read as follows:
Sec. 721.4472 Phenyl, alkyl, hydroxyalkyl substituted imidazole
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenyl,
alkyl, hydroxyalkyl substituted imidazole (PMNs P-98-843 and P-86-65)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(iv), (a)(5)(v), (a)(5)(vi),
(b) (concentration set at 1.0 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), and (g)(1)(iii).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(r) (56,000 kg) (acute oral study (OPPTS
870.1100 test
[[Page 371]]
guideline) followed by a (90-day subchronic inhalation study in rats
(40 CFR 799.9346). A person may not manufacture or import the substance
beyond the aggregate production volume limit, unless that person
conducts this study on the substance and submits all final reports and
underlying data in accordance with the procedures and criteria
specified in paragraphs (a)(2)(iii)(A), (a)(2)(iii)(B), (a)(2)(iii)(C),
and (a)(2)(iii)(D) of this section.
(A) Each study required to be performed pursuant to this section
must be scientifically valid. Scientifically valid means that the study
was conducted according to:
(1) The test guidelines specified in paragraph (a)(2)(iii) of this
section.
(2) An EPA-approved protocol.
(3) TSCA Good Laboratory Practice Standards at 40 CFR part 792.
(4) Using methodologies generally accepted at the time the study is
initiated.
(5) Any deviation from these requirements must be approved in
writing by EPA.
(B) Before starting to conduct any of the studies in paragraph
(a)(2)(iii) of this section, the person must obtain approval of test
protocols from EPA by submitting written protocols. EPA will respond to
the person within 4 weeks of receiving the written protocols. Published
test guidelines specified in paragraph (a)(2)(iii) of this section
(e.g., 40 CFR part 797 or part 798) provide general guidance for
development of test protocols, but are not themselves acceptable
protocols.
(C) The person shall:
(1) Conduct each study in good faith with due care.
(2) Promptly furnish to EPA the results of any interim phase of
each study.
(3) Submit, in triplicate (with an additional sanitized copy, if
confidential business information is involved), the final report of
each study and all underlying data (``the report and data'') to EPA no
later than 14 weeks prior to exceeding the applicable production volume
limit. The final report shall contain the contents specified in 40 CFR
792.185.
(D)(1) Except as described in paragraph (a)(2)(iii)(D)(2), if,
within 6 weeks of EPA's receipt of a test report and data, the person
receives written notice that EPA finds that the data generated by a
study are scientifically invalid, the person is prohibited from further
manufacture and import of the PMN substance beyond the applicable
production volume limit.
(2) The person may continue to manufacture and import the PMN
substance beyond the applicable production limit only if so notified,
in writing, by EPA in response to the person's compliance with either
of the following paragraphs (a)(2)(iii)(D)(2)(i) or
(a)(2)(iii)(D)(2)(ii) of this section.
(i) The person may reconduct the study. If there is sufficient time
to reconduct the study and submit the report and data to EPA at least
14 weeks before exceeding the production limit as required by paragraph
(a)(2)(iii)(C)(3) of this section, the person shall comply with
paragraph (a)(2)(iii)(C)(3) of this section. If there is insufficient
time for the person to comply with paragraph (a)(2)(iii)(C)(3) of this
section, the person may exceed the production limit and shall submit
the report and data in triplicate to EPA within a reasonable period of
time, all as specified by EPA in the notice described in paragraph
(a)(2)(iii)(D)(1) of this section. EPA will respond to the person in
writing, within 6 weeks of receiving the person's report and data.
(ii) The person may, within 4 weeks of receiving from EPA the
notice described in paragraph (a)(2)(iii)(D)(1) of this section, submit
to EPA a written report refuting EPA's finding. EPA will respond to the
person in writing, within 4 weeks of receiving the person's report.
(E) The person is not required to conduct a study specified in
paragraph (a)(2)(iii) of this section if notified in writing by EPA
that it is unnecessary to conduct that study.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
27. By adding new Sec. 721.5185 to read as follows:
Sec. 721.5185 Morpholine, 4-(1-oxo-2-propenyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as morpholine, 4-(1-
oxo-2-propenyl)- (PMN P-95-169; CAS No. 5117-12-4) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iv), (a)(3)(i), (a)(3)(ii),
(a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii),
(a)(5)(xiv), (a)(5)(xv), (a)(6)(v), (b) (concentration set at 0. 1
percent), and (c). The following material has been tested in accordance
with the American Society for Testing Materials (ASTM) F739 method and
found by EPA to satisfy the consent order's and Sec. 721.63(a)(2)(i)
requirements for dermal protection to 100 percent PMN substance. The
following gloves have been tested in accordance with the ASTM F739 and
found to satisfy the requirement for use by EPA: Safety 4/4H EVOH/PE
laniinate, Ansell Edmont Neoprene number 865, and Solvex Nitrile Rubber
number 275. Gloves and other dermal protection may not be used for a
time period longer than they are actually tested and must be replaced
at the end of each work shift. For additional dermal protection
materials, a company must submit all test data to the Agency and must
receive written Agency approval for each type of material tested prior
to use of that material as worker dermal protection. However, for the
purposes of determining the imperviousness of gloves, up to 1 year
after the commencement of commercial manufacture or import, the
employer may use the method described in Sec. 721.63 (a)(3)(ii),
thereafter, they must use the method described in Sec. 721.63
(a)(3)(i).
(ii) [Reserved]
(iii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0. 1
percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(1)(v), (g)(1)(vi),
(g)(1)(vii), (g)(1)(ix), (g)(2)(ii), (g)(2)(iv), (g)(2)(v), (g)(3)(i),
(g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
(iv) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (a), (c), (f), (p): First trigger (1 year),
second (1,500,000), and third (2,000,000) or 1 year whichever is
greater then 7,750,000 or 5 years after the commencement of commercial
manufacture, whichever comes later and Sec. 721.80(y)(1).
(v) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). Disposal by landfill must
go to a RCRA hazardous waste landfill.
(vi) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
[[Page 372]]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance as specified in Sec. 721.125 (a), (b), (c), (d), (e), (f),
(g), (h), (i), (j), and (k).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
28. By adding new Sec. 721.5380 to subpart E to read as follows:
Sec. 721.5380 Mixed alkyl phenolic novolak resin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
alkyl phenolic novolak resin (PMN P-98-718) is subject to reporting
under this section for the significant new use described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
29. By adding new Sec. 721.5465 to subpart E to read as follows:
Sec. 721.5465 Amine salt of organic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amine
salt of organic acid (PMN P-98-1172) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
30. By adding new Sec. 721.9508 to subpart E to read as follows:
Sec. 721.9508 Perfluorinatedalkyl polyhydroxysilane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluorinatedalkyl polyhydroxysilane (PMN P-95-1400) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(1)(ix),
(g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(5). The following statement shall
appear on each label as specified in Sec. 721.72(b) and the MSDS as
specified in Sec. 721.72(c): This substance may cause death if inhaled.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1). Use in any formulation that contains
alkylbenzenesulfonate emulsifiers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance, as specified in Sec. 721.125 (a), (b), (c), (f), (g), (h),
and (i).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
31. By adding new Sec. 721.9509 to subpart E to read as follows:
Sec. 721.9509 Perfluorinatedalkyl polyalkoxysilane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluorinatedalkyl polyalkoxysilane (PMN P-95-1410) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(ii),
(g)(1)(iii), (g)(1)(iv), (g)(1)(vi), (g)(1)(viii), (g)(1)(ix),
(g)(2)(i), (g)(2)(ii), (g)(2)(v), (g)(5). The following statement shall
appear on each label as specified in Sec. 721.72(b) and the MSDS as
specified in Sec. 721.72(c): This substance may cause death if inhaled.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1). Use in any formulation that contains
alkylbenzenesulfonate emulsifiers.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance as specified in Sec. 721.125 (a), (b), (c), (f), (g), (h),
and (i).
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
32. By adding new Sec. 721.9513 to subpart E to read as follows:
Sec. 721.9513 Modified magnesium silicate polymer (generic). .
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified magnesium silicate polymer (PMN P-98-604) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), and (x)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
33. By adding new Sec. 721.9573 to subpart E to read as follows:
Sec. 721.9573 Substituted perfluoroalkyl sulfonamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted perfluoroalkyl sulfonamide (PMN P-98-645) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
[[Page 373]]
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
34. By adding new Sec. 721.9672 to subpart E to read as follows:
Sec. 721.9672 Amides, tall-oil fatty, N-[2-[2-
hydroxyethyl)amino]ethyl], reaction products with sulfur dioxide; fatty
acids, tall-oil, reaction products with 1-piperazineethanamine and
sulfur dioxide; fatty acids, tall-oil reaction products with sulfur
dioxide and triethylenetetramine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, tall-oil
fatty, N-[2-[2-hydroxyethyl)amino]ethyl], reaction products with sulfur
dioxide; fatty acids, tall-oil, reaction products with 1-
piperazineethanamine and sulfur dioxide; fatty acids, tall-oil reaction
products with sulfur dioxide and triethylenetetramine (PMN P-98-725;
CAS Nos. 202483-48-5, 203809-20-5, and 204401-83-2) is subject to
reporting under this section for the significant new use described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
35. By adding new Sec. 721.9785 to subpart E to read as follows:
Sec. 721.9785 Benzenesulfonic acid, 2,2'-[(1E)-1,2- ethenediyl]
bis[5-[[4-(methylamino)-6-[[4-[(methylamino)carbonyl]phenyl]amino]-
1,3,5-triazin-2-yl]amino]-,disodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenesulfonic
acid, 2,2'-[(1E)-1,2- ethenediyl] bis[5-[[4-(methylamino)-6-[[4-
[(methylamino)carbonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-
,disodium salt (PMN P-98-475; CAS No. 180850-95-7) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (q).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The following recordkeeping requirements are
applicable to manufacturers, importers, and processors of this
substance as specified in Sec. 721.125 (a), (b), (c), and (i).
(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.
36. By adding new Sec. 721.9790 to subpart E to read as follows:
Sec. 721.9790 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-
[bis(2-hydroxypropyl) amino]- 6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-
yl]amino]-, disodium salt, compd. with 2,2',2''-nitrilo-tris[ethanol]
(1:2); Benzenesulfonic acid, 5-[[4-[bis(2-hydroxyethyl)amino]-6-[(3-
sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[2-[4-[[4-[bis(2-
hydroxypropyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-
yl]amino]-2-sulfophenyl]ethenyl]-, disodium salt, compd. with 2,2',2''-
nitrilotris[ethanol] (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a Benzenesulfonic
acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2hydroxypropyl)amino]-6-[(3-
sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-, disodium salt, compd.
with 2,2',2''-nitrilotris[ethanol] (1:2); Benzenesulfonic acid, 5-[[4-
[bis(2-hydroxyethyl)amino]-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-
yl]amino]-2-[2-[4-[[4-[bis(2-hydroxypropyl)amino]-6-[(3-
sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl] ethenyl]-,
disodium salt, compd. with 2,2',2''-nitrilotris[ethanol] (1:2) (PMN P-
98-716; CAS Nos. 198716-46-0 and 198716-48-2) 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 (v)(1), (v)(2), (w)(1), (w)(2), (x)(1), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notfication requirements.
The provisions of Sec. 721.185 apply to this section.
37. By adding new Sec. 721.9795 to subpart E to read as follows:
Sec. 721.9795 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[(4,6-
dichloro-1,3,5-triazin-2-yl) amino]-, disodium salt, substituted with
dialkyl amines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[(4,6-dichloro-1,3,5-
triazin-2-yl)amino]-, disodium salt, substituted with dialkyl amines
(PMN P-98-774) is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (v)(1), (w)(1), (x)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
38. By adding new Sec. 721.9798 to subpart E to read as follows:
[[Page 374]]
Sec. 721.9798 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-
substituted-6-substituted-1,3,5-triazin-2-yl]amino]-, sodium salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-substituted-6-
substituted-1,3,5-triazin-2-yl]amino]-, sodium salt (PMN P-98-1222) 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), (v)(2), (w)(1), (w)(2), (x)(1), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
39. By adding new Sec. 721.9810 to subpart E to read as follows:
Sec. 721. 9810 Substituted amino alkyl triazinyl benzenesulfonic acid
derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted amino alkyl triazinyl benzenesulfonic acid derivative (PMN
P-98-1043) is subject to reporting under this section for the
significant new use described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
40. By adding new Sec. 721.9965 to subpart E to read as follows:
Sec. 721.9965 Fatty acids, C10-13 - branched, vinyl
esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fatty acids,
C10-13 - branched, vinyl esters (PMN P-97-482; CAS No.
184785-38-4) 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) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2), (a)(3), (a)(4), (a)(5)(ii) (if data on
Cartridge Service Life Testing has been reviewed and approved in
writing by EPA). The following respirators may be used as specified in
Sec. 721.63 (a)(5)(xii), (a)(5)(xiii), (a)(6)(i), (a)(6)(ii),
(a)(6)(iv), (a)(6)(v), (b) (concentration set at 1.0 percent), and (c).
As an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the NCEL
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 1 ppm.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(v), (g)(1)(vi), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii),
and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(4) and (b)(4) (N=6).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
[FR Doc. 00-179 Filed 1-4-00; 8:45 am]
BILLING CODE 6560-50-F