[Federal Register Volume 63, Number 14 (Thursday, January 22, 1998)]
[Rules and Regulations]
[Pages 3394-3441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1074]
[[Page 3393]]
_______________________________________________________________________
Part II
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 721
Significant New Uses of Certain Chemical Substances; Final Rule
Federal Register/Vol. 63, No. 14 / Thursday, January 22, 1998 / Rules
and Regulations
[[Page 3394]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50628; FRL-5720-3]
RIN 2070-AB27
Significant New Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: 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 163
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. EPA is promulgating this SNUR using direct final
procedures.
DATES: The effective date of this rule is March 23, 1998. This rule
shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.)
on February 5, 1998.
If EPA receives notice before February 23, 1998 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 for the substance for which the notice of
intent to comment is received and will issue a proposed SNUR providing
a 30-day period for public comment.
ADDRESSES: Each comment or notice of intent to submit adverse or
critical comment must bear the docket control number OPPTS-50628 and
the name(s) of the chemical substance(s) subject to the comment. All
comments should be sent in triplicate to: OPPT Document Control Officer
(7407), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 401 M Street, SW., Room G-099, East Tower,
Washington, DC 20460.
Comments and data may also be submitted electronically to:
oppt.ncic@epamail.epa.gov. Follow the instructions under Unit X of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each portion. This claim must be
made at the time that the information is submitted to EPA . If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are
available from the EPA Home Page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/fedrgstr/).
This SNUR will require persons to notify EPA at least 90 days
before commencing manufacturing 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 SNURs 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.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, 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 721.10.
II. Applicability of General Provisions
General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. Provisions relating to user fees appear at 40 CFR part 700.
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 section 5 (h)(1), (2), (3), and
(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 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 and and the
specific chemical identity is not claimed as CBI), basis for the action
taken by EPA in the TSCA section 5(e) consent order or as a non-
[[Page 3395]]
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 B
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) 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) 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) 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-95-266, 95-615/616, P-95-
941, P-95-973, P-95-1046, P-95-1115, P-95-1827, P-95-1854, P-95-2075,
P-96-262, P-96-291, P-96-317, P-96-576 through P-96-581, P-96-726
through P-96-744, P-96-803/804, P-96-1277/78, P-96-1482/1483, P-96-
1708, P-96-1509/1519, P-96-1548 through P-96-1551, P-97-205 through P-
97-208, and P-97-276/277 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) order is
usually completed within 1 to 2 years of notice of commencement (NOC).
EPA's experience with exposure-based SNURs requiring short-term testing
is that the SNUR is often revoked within 1 to 2 years when the test
results are received. Rather than issue and revoke SNURs in such a
short span of time, EPA will defer publication of exposure-based SNURs
until either a NOC or data demonstrating risk are received unless the
toxicity testing required is long-term. EPA is issuing this explanation
and notification as required in 40 CFR 721.160(a)(2) as it has
determined that SNURs are not needed at this time for these substances
which are subject to a final TSCA section 5(e) consent order under
TSCA.
PMN Number P-87-323
Chemical name: (generic) Poly(oxy-1,2-ethanediyl), alpha substituted-
omega-hydroxy-, C16-20 alkyl ethers.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on submitted fish, daphnia, and algae tests on the PMN substance,
EPA expects toxicity to aquatic organisms at surface water
concentrations as low as 20 parts per billion (ppb). EPA determined
that use of the substance as described in the PMN did not present an
unreasonable risk because the substance did not exceed a concentration
of 20 ppb when released to surface waters. EPA has determined that
other uses may result in releases to surface waters above 20 ppb. Based
on this information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.3488.
PMN Number P-88-1108
Chemical name: (generic) Alcohols, C6-12, ethoxylated,
reaction product with maleic anhydride.
CAS number: Not available.
Basis for action: The PMN substance will be used as a plastics
additive. Based on analogy to anionic surfactants, 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. EPA determined that
use of the substance as described in the PMN did not present an
unreasonable risk because the substance would not be released to
surface waters in significant quantities. EPA has determined that other
uses of the substance may result in releases to surface waters which
exceed the concern concentration. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.524.
PMN Number P-90-581
Chemical name: (generic) Brominated phthalate ester.
CAS number: Not available.
Effective date of section 5(e) consent order: March 21, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health and the environment.
Toxicity concern: Similar chemicals have been shown to form
dibenzodioxins and dibenzofurans when incinerated under combustion
conditions of municipal incinerators.
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Recommended 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 PMN submitter has agreed not to exceed the production
volume limit without performing this study.
CFR citation: 40 CFR 721.3085.
PMN Numbers P-91-1131 and P-90-564
Chemical name: (generic) Imidazolethione.
CAS number: Not available.
Effective date of section 5(e) consent order: October 25, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Based on the submitted 90-day subchronic study, the
PMN substance causes thyroid and other systemic effects in test
animals. Based on the submitted developmental toxicity study, the PMN
substance causes developmental toxicity in test animals. Based on
analogy to structurally similar substances the PMN substance may cause
thyroid cancer.
Recommended testing: A 2-year, two-species oral bioassay in rats (40
CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) is
recommended to help characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.4469.
PMN Number P-92-314
Chemical name: (generic) Aryloxyarene.
CAS number: Not available.
Effective date of section 5(e) consent order: March 11, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to the
environment.
Toxicity concern: Based on test data on this substance, there is
concern for toxicity to aquatic organisms, particularly effects on
daphnid reproduction, at concentrations as low as 1 ppb in surface
waters.
Recommended testing: A 28-day chironomid sediment toxicity study (OPPTS
850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996))
(FRL-5363-1) is recommended to help characterize the toxicity of the
PMN substance to benthic organisms.
CFR citation: 40 CFR 721.977.
PMN Numbers P-93-204 and P-94-1870 through P-94-1874
Chemical name: (generic) Phenyl substituted triazolinones.
CAS numbers: Not available.
Effective date of section 5(e) consent order: July 23, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that these substances may present an unreasonable risk of injury to
human health and the environment.
Toxicity concern: Data on several of the PMN substances and a chemical
similar to P-94-1870 have shown developmental and reproductive effects,
blood and liver effects, and neurotoxicity in test animals.
Recommended testing: An oral developmental toxicity study in rats (40
CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) and a 90-day
subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7))
would help characterize the human health effects. A semi-continuous
activated sludge (SCAS) study (OPPTS 835.3210 test guideline (public
draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1), a ready
biodegradability study (OPPTS 835.3110 test guideline (public draft; 61
FR 16486, April 15, 1996)) (FRL-5363-1), and a soil sediment adsorption
isotherm (40 CFR 796.2750 or OPPTS 835.1220 test guideline (public
draft; 61 FR 16486, April 15, 1996) (FRL-5363-1) would help
characterize the environmental effects of the substance.
CFR citation: 40 CFR 721.9825.
PMN Number P-93-568
Chemical name: (generic) Polysubstituted piperidine.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on submitted test data, 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. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance would not be released to surface waters above a level of
30 ppb. EPA has determined that other uses of the substance may result
in releases to surface waters which exceed the concern concentration.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.6165.
PMN Number P-93-761
Chemical name: 2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.
CAS number: 146453-62-5.
Effective date of section 5(e) consent order: September 6, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Test data on the PMN substance and similar chemicals
have shown that these types of chemicals cause systemic toxicity and
neurotoxicity in test animals.
Recommended testing: A 90-day oral subchronic study in rats (40 CFR
798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522,
June 20, 1996) (FRL-5367-7)) with additional neurotoxicity endpoints
following NTIS-PB91-154617 (functional observation battery,
neurohistopathology and motor activity) would help to characterize the
systemic and neurotoxicity effects. The PMN submitter has agreed not to
exceed the production volume limit without performing this test.
CFR citation: 40 CFR 721.9005.
PMN Number P-93-1369
Chemical name: (generic) N,N'-di(alkyl heteromonocycle)amino
chlorotriazine.
CAS number: Not available.
Effective date of section 5(e) consent order: June 13, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health and the environment.
Toxicity concern: Similar chemicals have been shown to cause systemic
toxicity, developmental toxicity, and cancer in test animals. In
addition, similar chemicals have been shown to be toxic to aquatic
organisms.
Recommended testing: EPA has determined that a 90-day subchronic
toxicity test in rats via gavage (40 CFR 798.2650 or OPPTS 870.3100
test guideline (public draft; 61 FR 31522,
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June 20, 1996) (FRL-5367-7)), a two-species developmental study (rodent
and non-rodent) (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-
5719-5) and a 2-year, one-species bioassay (rats) (40 CFR 799.9420) (62
FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the
human health effects of the PMN substance. The 90-day subchronic
toxicity test should include special emphasis on hematology; weight of
the spleen and thymus; cellularity of the bone marrow, thymus, and
spleen; and histopathology of the liver, kidney, heart, and all
endocrine glands for which weight changes are observed. In addition
natural killer cell activity should be evaluated on the same population
of test animals, and IgM antibody plaque-forming cells should be
enumerated in two satellite groups of animals (10 in the high-dose
group and 10 in the control group). EPA has determined that a fish
acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid
acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. 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 toxicity test. The PMN submitter has also agreed not to
exceed the second higher production volume limit without performing the
two-species developmental study and the 2-year, one-species bioassay if
the results of the 90-day test indicate biological activity at low
levels (i.e., activity levels comparable to those for triazines).
CFR citation: 40 CFR 721.2094.
PMN Number P-93-1631
Chemical name: (generic) Substituted naphtholazo-substituted
naphthalenyl-substituted azonaphthol chromium complex.
CAS number: Not available.
Basis for action: The PMN substance will be used as a dye. Based on
analogy to structurally similar substances, EPA is concerned that
cancer will occur in exposed workers. Based on submitted test data, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substance in surface waters.
EPA determined that use of the substance did not present an
unreasonable risk because significant worker or environmental exposure
is not expected because the substance was used as a liquid and was not
manufactured domestically. EPA has determined that domestic manufacture
of the substance and use as a solid may result in significant worker or
environmental exposure. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(1)(i)(D).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
would help characterize the health effects of the PMN substance and a
chronic 60-day fish early life stage toxicity test in rainbow trout (40
CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic
toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public
draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.981.
PMN Number P-93-1654
Chemical name: (generic) Substituted polyoxyethylene.
CAS number: Not available.
Basis for action: The PMN substance will be used as an emulsifier for
paint and adhesives. Based on submitted test data and analogy to
nonionic surfactants, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 9 ppb of the PMN
substance in surface waters. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface water at concentrations above 9 ppb. Based on this information
the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.7378.
PMN Number P-94-209
Chemical name: Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
CAS number: 134701-20-5.
Basis for action: The PMN substance will be used as an antioxidant.
Based on submitted test data, there is concern for liver toxicity,
kidney toxicity, adrenal toxicity, and blood toxicity. Based on
submitted test data and analogy to phenols, EPA is also concerned that
toxicity to aquatic organisms will occur at concentrations as low as 1
ppb. EPA determined that use of the substance as described in the PMN
did not present an unreasonable risk because workers would not be
subject to significant dermal exposures and there were no significant
environmental releases. EPA has determined that other uses of the
substance may result in significant dermal exposures to workers and
significant environmental releases. Based on this information the PMN
substance meet the concern criteria at Sec. 721.170 (b)(3)(i) and
(b)(4)(i).
Recommended testing: EPA has determined that a dermal absorption study,
a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)), a chronic 60-day fish early life stage toxicity test in
rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public
draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and a 21-day daphnid
chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help
characterize the health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5725.
PMN Number P-94-921
Chemical name: Phenol, 4,4'-methylenebis[2,6-dimethyl-.
CAS number: 5384-21-4.
Effective date of section 5(e) consent order: July 5, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health and the environment.
Toxicity concern: Similar phenols have been shown to cause kidney and
liver toxicity, and blood effects in test animals. In addition, chronic
fish and daphnid tests and a high bioconcentration potential indicated
a concern concentration of 6 ppb.
Recommended testing: EPA has determined that a 90-day subchronic
[[Page 3398]]
oral toxicity test in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7))
would help to characterize the human health effects of the PMN
substance. EPA has also determined that a modified SCAS test (OPPTS
835.3210 test guideline (public draft; 61 FR 16486, April 15, 1996))
(FRL-5363-1), an aerobic aquatic biodegradation test (40 CFR 796.3100
or OPPTS 835.3100 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1), and an anaerobic biodegradability of organic
chemicals (OPPTS 835.3400 test guideline (public draft; 61 FR 16486,
April 15, 1996)) (FRL-5363-1) would help to charactarize the
environmental effects. The PMN submitter has agreed not to exceed the
production volume limit without performing the 90-day subchronic
toxicity test.
CFR citation: 40 CFR 721.5730.
PMN Number P-94-1017
Chemical name: Urea, tetraethyl-.
CAS number: 1187-03-7.
Basis for action: The PMN substance will be used as an intermediate.
Based on submitted test data EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 1 ppm of the PMN
substance in surface waters. Based on analogy to similar ureas and
submitted test data EPA is concerned that acute toxicity, mutagenicity,
developmental effects, and reproductive effects could occur to exposed
workers. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because the substance would
not be released to surface waters and exposed workers would wear
adequate protective equipment to prevent dermal exposure. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration or dermal
exposure to workers. Based on this information the PMN substance meets
the concern criteria at Sec. 721.170 (b)(2), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance. EPA has determined that a dermal
developmental toxicity test in rabbits and rats (40 CFR 799.9370) (62
FR 43832, August 15, 1997) (FRL-5719-5) and a chromosome aberration
assay in mice (40 CFR 798.9538) (62 FR 43850, August 15, 1997) (FRL-
5719-5) or a micronucleus assay in mice (40 CFR 798.9539) (62 FR 43853,
August 15, 1997) (FRL-5719-5) would help characterize the health
effects of the PMN substance. The PMN submitter has agreed to conduct
the health tests before reaching the production volume limit in the
SNUR.
CFR citation: 40 CFR 721.9928.
PMN Number P-94-1018
Chemical name: Guanidine, pentaethyl-.
CAS number: 13439-89-9.
Basis for action: The PMN substance will be used as an intermediate.
Based on submitted test data, EPA is concerned that acute toxicity,
corrosivity, and neurotoxicity could occur to exposed workers. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because exposed workers would wear
adequate protective equipment to prevent dermal exposure. EPA has
determined that other uses of the substance may result in exposure to
workers. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170 (b)(2) and (b)(3)(i).
Recommended testing: None.
CFR citation: 40 CFR 721.4085.
PMN Number P-94-1019
Chemical name: Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-,
bromide.
CAS number: 89610-32-2.
Basis for action: The PMN substance will be used as a catalyst. Based
on submitted test data, 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. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.4090.
PMN Number P-94-1143
Chemical name: Butanoic acid, antimony (3+) salt.
CAS number: 53856-17-0.
Effective date of section 5(e) consent order: July 7, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health.
Toxicity concern: Similar chemicals have been shown to cause cancer,
dermal and ocular irritation, cardiovascular effects, neurotoxic
effects, reproductive toxicity, and developmental toxicity in test
animals.
Recommended testing: A pharmacokinetic test (OPPTS 870.8223 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) is
recommended to help determine the bioavailability of the PMN substance
after dermal administration. The PMN submitter has agreed not to exceed
the production volume limit without performing this test.
CFR citation: 40 CFR 721.1930.
PMN Number P-94-1743
Chemical name: (generic) Isophorone diisocyanate neopentyl glycol
adipate polyurethane prepolymer.
CAS number: Not available.
Effective date of section 5(e) consent order: December 8, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Test data on the substance and similar diisocyanates
have shown them to cause skin sensitization and chronic lung toxicity
in test animals.
Recommended testing: EPA has determined that the results of an acute
inhalation study (OPPTS 870.1300 test guideline (public draft; 61 FR
31522, June 20, 1996) (FRL-5367-7)), a 28-day subchronic inhalation
study in rats, (Organization for Economic Cooperation and Development
(OECD) guideline no. 412), and a 90-day subchronic inhalation toxicity
study in rats (40 CFR 798.2450 or OPPT 870.3465 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to
characterize the health effects caused by the substance. The PMN
submitter has agreed not to exceed the
[[Page 3399]]
production volume limit without performing these tests.
CFR citation: 40 CFR 721.8079.
PMN Number P-94-2159
Chemical name: (generic) Anthraquinone dye.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on submitted test data and 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.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170 (b)(4)(i).
Recommended testing: EPA has determined that a fish acute toxicity
study modified with humic acid (40 CFR 797.1400 or OPPTS 850.1085 test
guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.723.
PMN Number P-95-168
Chemical name: Phosphonic acid, methylenebis-, tetrakis(1-methylethyl)
ester.
CAS number: 1660-95-3.
Effective date of section 5(e) consent order: September 20, 1995.
Basis for section 5(e) consent order: The Order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Similar dimethyl methyl phosphonate (DMMP) and
diisopropyl methylphosphonate (DIMP) chemical substances have been
shown to cause oncogenicity in test animals. In addition the PMN
substance was demonstrated to be a chromosome mutagen in a mouse
lymphoma study.
Recommended testing: The Agency has determined that the results of a 2-
year bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-
5719-5) would help to characterize possible human effects of the
substance.
CFR citation: 40 CFR 721.6075.
PMN Number P-95-243
Chemical name: Phenol, 4-(1,1-dimethylethyl)-, homopolymer.
CAS number: 30813-81-1.
Effective date of section 5(e) consent order: October 5, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to the
aquatic environment.
Toxicity concern: The PMN substance has been shown to be toxic to
aquatic organisms. However, the substance also has the advantages of
eliminating or reducing volatile organic solvents, and reducing
exposures to residual monomers. EPA has evaluated two processor/use
sites where releases sometimes exceed the concern level. In light of
the benefits of the substance, EPA determined these releases did not
constitute an unreasonable risk and will allow releases at these sites
in the section 5(e) consent order and SNUR.
Recommended testing: EPA has determined that an activated sludge
adsorption isotherm study (OPPTS 835.1110 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1), a chronic 60-day fish early
life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS
850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 797.1330
or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), or a chironomid sediment toxicity test (OPPTS
850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)) would help characterize possible effects of the PMN
substance in the aquatic environment. The consent order contains two
production limits. The PMN submitter has agreed not to exceed the first
production limit without performing the activated sludge adsorption
isotherm test. The PMN submitter has also agreed not to exceed the
second higher production limit without performing either the fish early
life stage with rainbow trout and the daphnid chronic toxicity tests,
or the chironomid sediment toxicity test, depending on the results of
the activated sludge adsorption isotherm test.
CFR citation: 40 CFR 721.538.
PMN Number P-95-535
Chemical name: Reaction products of formalin (37%) with amine
C12.
CAS number: Not available.
Basis for action: The PMN substance will be used as an oilfield
chemical. Based on analogy to aliphatic amines, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 20
ppb of the PMN substance in surface waters. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because the substance would not be released to surface waters. EPA
has determined that other uses of the substance may result in releases
to surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9285.
PMN Numbers P-95-605/606
Chemical name: (generic) Trifunctional ketoximino silane.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy of the hydrolysis product of the PMN substances
to similar compounds, EPA is concerned that cancer and blood effects
could occur to exposed workers. EPA determined that use of the
substances as described in the PMN did not present an unreasonable risk
because exposed workers would wear adequate protective equipment to
prevent dermal exposure. EPA has determined that other uses of the
substance may result in dermal exposure to workers. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
Recommended testing: EPA has determined that a 90-day subchronic study
in rats by the oral route (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and
a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR 43838, August
15, 1997) (FRL-5719-5) would help characterize the health effects of
the PMN substance.
CFR citation: 40 CFR 721.9497.
PMN Number P-95-633
Chemical name: (generic) Sodium salt of azo acid dye.
CAS number: Not available.
Basis for action: The PMN substance will be used in a non-dispersive
use.
[[Page 3400]]
Based on analogy of the azo reduction products to structurally similar
substances, EPA is concerned that cancer and systemic toxicity will
occur in exposed workers. EPA determined that use of the substance did
not present an unreasonable risk because significant worker exposure is
not expected because the substance was not manufactured, processed, or
used as a powder. EPA has determined that manufacture, processing, and
use of the substance as a powder may result in significant worker
exposure. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
Recommended testing: EPA has determined that a 90-day subchronic study
in rats by the oral route with special attention to the liver, kidney,
spleen, and blood (40 CFR 798.2650 or OPPTS 870.3100 test guideline
(public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help
characterize the health effects of the substance.
CFR citation: 40 CFR 721.980.
PMN Number P-95-637
Chemical name: 2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.
CAS number: 72804-49-0.
Basis for action: The PMN substance will be used as an intermediate.
Based on toxicity data submitted with the PMN, EPA identified health
concerns for neurotoxicity. EPA determined that use of the substance as
described in the PMN did not present an unreasonable risk because
significant human exposure is not expected. EPA has determined that use
of the substance other than as described in the PMN may result in
significant human exposure. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170 (b)(3)(i).
Recommended testing: None.
CFR citation: 40 CFR 721.5708.
PMN Number P-95-638
Chemical name: Pentane 1,1,1,2,2,3,4,5,5,5,-decafluoro.
CAS number: 138495-42-8.
Basis for action: The PMN substance will be used as described in the
PMN. Based on toxicity data submitted with the PMN, EPA identified
health concerns for neurotoxicity. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because significant human exposure is not expected. EPA has determined
that use of the substance other than as described in the PMN may result
in significant human exposure. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: None.
CFR citation: 40 CFR 721.5645.
PMN Number P-95-666
Chemical name: (generic) Polyether acrylate.
CAS number: Not available.
Basis for action: The PMN substance will be used in a radiation curing
formulation. Based on analogy to acrylates, EPA identified concerns for
toxicity to aquatic organisms. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
significant environmental exposure is not expected. EPA has determined
that other uses may result in releases to water which are significant
environmental exposures. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.405.
PMN Numbers P-95-677/724
Chemical name: (generic) Antimony double oxide.
CAS number: Not available.
Effective date of section 5(e) consent order: March 12, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health and the environment.
Toxicity concern: Similar chemicals have been shown to cause cancer,
lung toxicity and ocular effects in test animals. In addition to human
health concerns, an aquatic toxicity concern has been identified if the
substance is released to surface waters. A concern concentration of 5
ppb has been established.
Recommended testing: EPA has determined that a 2-year, one-species rat
inhalation bioassay, which has an additional holding period, analyses
of lung burdens, and determination of clearance rates of particles (as
described at (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-
5719-5) would help characterize the carcinogenicity, lung toxicity and
ocular effects of the PMN substance. In addition, EPA has determined
that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075
test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010
test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS
850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)) would help characterize the environmental effects of the
PMN substances.
CFR citation: 40 CFR 721.5547.
PMN Numbers P-95-1103, P-95-1104, and P-96-1235
Chemical name: (generic) Substituted resorcinols.
CAS number: Not available.
Basis for action: The PMN substances will be used as components of a
material for integrated circuit fabrication. Based on submitted
toxicity data and analogy to phenols, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 9 ppb of P-95-
1103/P-95-1104 and 1 ppb of P-96-1235 in surface waters. EPA determined
that use of the substances as described in the PMNs did not present an
unreasonable risk because the substances would not be released to
surface waters in significant quantities. EPA has determined that other
uses of the substances may result in releases to surface waters which
exceed the concern concentration. Based on this information the PMN
substances meet the concern criteria at Sec. 721.170(b)(4)(i) and
(b)(4)(ii).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of P-95-1103 and P-95-1104. EPA has also determined that a fish
acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid
acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal
acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline
(public draft; 61 FR 16486,
[[Page 3401]]
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of P-96-1235.
CFR citation: 40 CFR 721.9488.
PMN Number P-95-1128
Chemical name: (generic) Brominated aromatic ester.
CAS number: Not available.
Effective date of section 5(e) consent order: November 5, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and 5(e)(1)(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: Similar chemicals have been shown to: (1) Degrade in
the environment resulting in substances that may cause aquatic
toxicity, and (2) form dibenzodioxins and dibenzofurans when
incinerated under combustion conditions of municipal incinerators. EPA
has determined that halogenated dioxins and furans are probable human
carcinogens and may cause toxic effects in aquatic and terrestrial
organisms.
Recommended testing: The consent order contains two production volume
limits. The PMN submitter has agreed not to exceed the first production
volume limit without performing an incineration simulation study
(guidelines available from EPA) to help characterize the potential for
the formation of dibenzodioxins or dibenzofurans when plastics or
resins containing the substance are incinerated, and a porous pot test
(OPPTS 835.3220 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1) to determine the extent of environmental degradation
of the substance. The PMN submitter has also agreed not to exceed the
second, higher production volume limit without performing a shake flask
die-away test (OPPTS 835.3170 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1), a fish bioconcentration test
(OPPTS 850.1730 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a fish acute toxicity study (40 CFR 797.1400 or
OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or
OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050
or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)).
CFR citation: 40 CFR 721.2925.
PMN Number P-95-1213
Chemical name: (generic) Hydroxy terminated polyester.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to esters, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 200 ppb of the PMN
substance in surface waters. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface water at concentrations above 200 ppb. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6485.
PMN Number P-95-1235
Chemical name: 2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-
sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-
(phenylamino)-, sodium salt, compd. With 2,2',2''-nitrilotris [ethanol]
(9CI).
CAS number: 94213-53-3.
Basis for action: The PMN substance will be used in an open non-
dispersive use. Based on analogy of the azo reduction products to
similar substances, EPA is concerned that cancer, systemic toxicity,
developmental toxicity, methemoglobinemia, and skin sensitization will
occur in exposed workers. EPA determined that use of the substance did
not present an unreasonable risk because significant worker exposure is
not expected because the substance was not manufactured, processed, or
used as a powder or manufactured domestically. EPA has determined that
manufacture, processing, and use of the substance as a powder or
domestic manufacture may result in significant worker exposure. Based
on this information the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(iii).
Recommended testing: EPA has determined that an Ames assay with the
Prival modification with a concurrent positive control would help
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.5281.
PMN Number P-95-1282
Chemical name: (generic) Reaction product of dichlorobenzidine and
substituted alkylamide.
CAS number: Not available.
Effective date of section 5(e) consent order: July 29, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health.
Toxicity concern: 3,3'-dichlorobenzidine (DCB) and possible reduction
products have been shown to cause oncogenicity and mutagenicity in test
animals.
Recommended testing: The following studies would help characterize the
health effects of the PMN substance: Monitoring data to detect the
presence of DCB under actual conditions of use in polymer coloration or
sheet metal coating use (Az, R., Dewald B. and Scnaitmann, D. 1991.
Pigment Decomposition in Polymers in Applications at Elevated
Temperatures (Dyes and Pigments 15:1-14). Monitoring data would include
the following elements: Extrusion or other process), monitoring data to
detect airborne concentrations of DCB during high-temperature
coloration or sheet metal coating use (see TSCA section 8(e) data e.g.,
section 8(e)-962 supp.), radio-labeled pharmacokinetic study (oral) in
rats on the pigment (with the radio-label on the DCB) (OPPTS 870.7485
test guideline (public draft; 60 FR 45158, August 30, 1995) (FRL-4973-
2)) plus radio-label), and a 2-year, two-species bioassay (40 CFR
799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5).
CFR citation: 40 CFR 721.9265.
PMN Number P-95-1288
Chemical name: 2-Naphthalenol, mono and dioctyl derivs.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to phenols, EPA is concerned that toxicity to aquatic
organisms may occur at a concentrations as low as 1 ppb of the PMN
substance in surface waters. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance did not exceed a concentration of 1 ppb when released to
surface waters. EPA has determined that increased production
[[Page 3402]]
volume may result in releases to surface waters above 1 ppb. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5255.
PMN Number P-95-1317
Chemical name: (generic) Hydrochlorofluorocarbon.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on toxicity data submitted with the PMN, EPA identified health
concerns for neurotoxicity. Based on analogy to structurally similar
chemicals, EPA identified health concerns for cardiac sensitization,
liver toxicity, kidney toxicity, and skin irritation. EPA determined
that use of the substance as described in the PMN did not present an
unreasonable risk because significant human exposure is not expected.
EPA has determined that use of the substance other than as described in
the PMN may result in significant human exposure. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: None.
CFR citation: 40 CFR 721.4462.
PMN Number P-95-1326
Chemical name: 3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.
CAS number: 16068-37-4.
Basis for action: The PMN substance will be used in treatment of
laminates for printed circuit boards and sol-gel ceramics. Based on
analogy to alkoxysilanes, EPA is concerned that a significant risk of
lung toxicity and severe irritation to skin, eyes, and mucous membranes
could occur. EPA determined that use of the substance did not present
an unreasonable risk because the substance would not be manufactured,
processed, or used in a manner that generated a vapor, mist, or aerosol
and significant worker inhalation exposure is not expected. EPA has
determined that manufacture, processing, or use of the substance in a
manner that generated a vapor, mist, or aerosol may result in
significant worker inhalation exposure. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rats (40 CFR 798.2450 or OPPTS 870.3465 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7))
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.3155.
PMN Number P-95-1347
Chemical name: (generic) Aliphatic polyisocyanate.
CAS number: Not available.
Basis for action: The PMN substance will be used in an open non-
dispersive use. Based on analogy to diisocyanates, there is concern for
lung toxicity, pulmonary sensitization, and irritation to mucous
membranes. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because workers would not be
subject to significant inhalation exposures. EPA has determined that
uses of the substance that generate a mist, aerosol, or vapor may
result in significant inhalation exposures to workers. Based on this
information the PMN substance meet the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has also determined that a 90-day subchronic
inhalation study in rats (40 CFR 799.9346) (62 FR 43828, August 15,
1997) (FRL-5719-5) would help characterize the health effects of the
PMN substance.
CFR citation: 40 CFR 721.6495.
PMN Number P-95-1356
Chemical name: (generic) Silylated polyurethane.
CAS Number: Not available.
Basis for action: The PMN substance will be used as a moisture curable
polymer. Based on analogy of the PMN substance to alkoxysilanes, EPA
expects irritation to mucous membranes and lung toxicity. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because there were no significant
inhalation exposures. EPA has determined that use of the substance
generating an aerosol or a mist may result in significant inhalation
exposures. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study (40 CFR 798.2450 or OPPTS 870.3465 test guideline
(public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.8095.
PMN Number P-95-1386
Chemical name: Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer,
Bu alc.-blocked.
CAS number: 186321-98-2.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to diisocyanates, EPA is concerned that a
significant risk of oncogenicity, respiratory sensitization, and
chronic lung effects could occur. EPA determined that use of the
substance did not present an unreasonable risk because the substance
would not be manufactured, processed, or used in a manner that
generated a vapor, mist, or aerosol and significant worker inhalation
exposure is not expected. EPA has determined that manufacture,
processing, or use of the substance in a manner that generated a vapor,
mist, or aerosol may result in significant worker inhalation exposure.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170 (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation study
in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2535.
PMN Number P-95-1411
Chemical name: Propanedioic acid, [(4-methoxyphenyl)methylene]-,
bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).
CAS number: 147783-69-5.
Effective date of section 5(e) consent order: November 22, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and 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: Similar chemicals have been shown to cause toxicity
to the immune system, liver, blood, the male reproductive system and
the G.I. tract in test animals.
Recommended testing: A 90-day subchronic oral toxicity study in rats
(40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR
31522, June 20, 1996) (FRL-5367-7)) would help characterize the human
health effects. The PMN submitter has agreed not to exceed the
production volume limit without performing this test.
[[Page 3403]]
CFR citation: 40 CFR 721.4589.
PMN Number P-95-1466
Chemical name: (generic) Substituted aromatic aldehyde.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to phenols and aldehydes EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 3
ppb of the PMN substance in surface waters. EPA determined that use of
the substance as described in the PMNs did not present an unreasonable
risk because the substance would not be released to surface waters. EPA
has determined that other uses of the substance may result in releases
to surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.526.
PMN Number P-95-1467
Chemical name: Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.
CAS number: 174333-80-3.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to phenols, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 1 ppb of the
PMN substance in surface waters. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.528.
PMN Numbers P-95-1557/1558
Chemical name: (generic) Substituted imines.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on 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 substances in surface waters. EPA determined that use of the
substances as described in the PMNs did not present an unreasonable
risk because the substances would not be released to surface waters.
EPA has determined that other uses of the substances may result in
releases to surface waters which exceed the concern concentration.
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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.4476.
PMN Numbers P-95-1575/1576/1577
Chemical name: Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-
hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl]
propyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1575),
Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-
hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium
(9CI) (P-95-1576), Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
(aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalenesulfonato
(3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-
hydroxy-1-[(phenylamino) carbonyl]-1-propenyl]azo]-2-
naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1577).
CAS number: 119535-63-6 (P-95-1575), 118716-62-4 (P-95-1576), and
118716-61-3 (P-95-1577).
Basis for action: The PMN substances will be used as leather dyes.
Based on analogy to similar substances, EPA is concerned that cancer,
developmental, kidney, and liver toxicity will occur in exposed
workers. EPA determined that use of the substances did not present an
unreasonable risk because significant worker exposure is not expected
because the substances were not manufactured, processed, or used as a
powder. EPA has determined that manufacture, processing, and use of the
substances as a powder may result in significant worker exposure. Based
on this information the PMN substances meet the concern criteria at
Sec. 721.170 (b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
an oral 2-generation reproduction study in rats (40 CFR 799.9380) (62
FR 43834, August 15, 1997) (FRL-5719-5), and a 90-day subchronic
inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7))
would help characterize the health effects of the PMN substances.
CFR citation: 40 CFR 721.9575 (P-95-1575), 40 CFR 721.9576 (P-95-1576),
and 40 CFR 721.9577 (P-95-1577).
PMN Number P-95-1578
Chemical name: (generic) Hydrofluorocarbon alkyl ether.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to similar substances, EPA identified concerns for
cancer, cardiotoxicity, cardiosensitization, respiratory failure,
neurotoxicity, and irritation to membranes. Based on submitted test
data EPA identified concerns for acute toxicity. EPA determined that
use of the substance as described in the PMN did not present an
unreasonable risk because significant human exposure is not expected.
EPA has determined that use of the substance without the worker
protection cited in the PMN or if the substance is used other than as
an intermediate may result in significant human exposure. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species
bioassay (40 CFR 799.9420) (62 FR
[[Page 3404]]
43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study
in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) will address the
potential health effects of the PMN substance.
CFR citation: 40 CFR 721.3485.
PMN Numbers P-95-1650/1651/1652/1653
Chemical name: (generic) Alkyl phenyl polyetheramines.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on analogy to aliphatic amines EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 3 ppb of the
PMN substances in surface waters. EPA determined that use of the
substances as described in the PMNs did not present an unreasonable
risk because the substances would not be released to surface waters.
EPA has determined that other uses of the substances may result in
releases to surface waters which exceed the concern concentration.
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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6490.
PMN Number P-95-1750
Chemical name: (generic) Pentanediol light residues.
CAS number: Not available.
Basis for action: The PMN substance will be used as a solvent. Based on
potential consumer exposures, EPA has determined that the PMN substance
may cause significant or substantial human exposure. EPA determined
that use of the substance as described in the PMN did not cause
significant or substantial exposure from use as an industrial solvent.
EPA has determined that exposures from consumer use may result in
significant or substantial human exposures. Based on this information
activities other than those described in the PMN may result in
significant changes in human exposure.
Recommended testing: EPA has determined that a 28-day oral study in
rats (OECD guideline no. 407), an acute rat oral study (OPPTS 870.1100
test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-
7)), an ames assay (40 CFR 798.5265 or OPPTS 870.5265 test guideline
(public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a mouse
micronucleus assay by the intraperitoneal route (40 CFR 799.9539) (62
FR 43853, August 15, 1997) (FRL-5719-5), and a developmental toxicity
study in one species by the oral route (40 CFR 799.9370) (62 FR 43832,
August 15, 1997) (FRL-5719-5) would help characterize possible health
effects of the substance. EPA will require any manufacturer importer,
or processor who distributes this substance for use in a consumer
product to perform this testing.
CFR citation: 40 CFR 721.5650.
PMN Number P-95-1772
Chemical name: (generic) Polyalkyl phosphate.
CAS number: Not available.
Basis for action: The PMN substance will be used as a specialty
additive. Based on analogy to neutral organic substances, EPA expects
toxicity to aquatic organisms at surface water concentrations as low as
1 ppb. EPA determined that use of the substance as described in the PMN
did not present an unreasonable risk because the substance did not
exceed a concentration of 1 ppb when released to surface waters. EPA
has determined that other uses may result in releases to surface waters
above 1 ppb. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5995.
PMN Number P-95-1806
Chemical name: (generic) Quaternary ammonium hydroxide.
CAS number: Not available.
Basis for action: The PMN substance will be used as an additive. Based
on analogy to cationic 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance was not released to surface waters. EPA has
determined that other uses may result in releases to surface waters
above the concern concentration. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.4467.
PMN Number P-95-1825
Chemical name: Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).
CAS number: 126213-50-1.
Basis for action: The PMN substance will be used in an open non-
dispersive use. Based on analogy to structurally similar substances,
EPA identified concerns for cancer and based on submitted test data EPA
identified concerns for liver toxicity and neurotoxicity. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because significant human exposure is not
expected. EPA has determined that use of the substance without the
worker protection cited in the PMN or if the substance is manufactured
domestically may result in significant human exposure. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(C) and (b)(3)(i).
Recommended testing: EPA has determined that a 2-year, two-species
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)) will address the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.9662.
PMN Number P-95-1891
Chemical name: Siloxanes and silicones, Me hydrogen, reaction
[[Page 3405]]
products with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.
CAS number: 182635-99-0.
Basis for action: The PMN substance will be used as an ultraviolet
light stabilizer for polymers. Based on analogy to hindered amines,
there is concern for toxicity to the immune system and the G.I. tract,
liver toxicity, blood toxicity, and toxicity to the male reproductive
system. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because workers would not be
exposed by inhalation. EPA determined that use as a powder may result
in inhalation exposure to workers. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7))
would characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.6170.
PMN Number P-95-1950
Chemical name: (generic) Substituted ethoxyethylamine phosphonate.
CAS number: Not available.
Basis for action: The PMN substance will be used as a scale inhibitor.
Based on analogy to polyanionic monomers, 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. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because the substance was not released to surface waters. EPA has
determined that other uses may result in releases to surface waters
above 30 ppb. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6078.
PMN Number P-95-2101
Chemical name: Hydrazine, (2-fluorophenyl).
CAS Number: 2368-80-1.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy of the PMN substance to hydrazines EPA is concerned
that oncogenicity, liver and kidney effects, lung effects, and blood
effects will occur to exposed workers and that toxicity will occur to
aquatic organisms. EPA determined that use of the substance as
described in the PMN did not present an unreasonable risk because there
were no significant worker or environmental exposures. EPA has
determined that domestic manufacture of the substance may result in
significant worker and environmental exposures. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)) would help characterize the health effects of the PMN
substance. A fish acute toxicity study (40 CFR 797.1400 or OPPTS
850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS
850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or
OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) would help characterize the environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.4257.
PMN Number P-96-19
Chemical name: Lithiated metal oxide (LiNiO2).
CAS number: 12031-65-1.
Effective date of section 5(e) consent order: June 26, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health and the environment.
Toxicity concern: Similar chemicals have been shown to cause cancer and
systemic toxicity in test animals. In addition, based on Structure
Activity Relationship (SAR) analysis derived from test data on
structurally similar compounds, EPA expects toxicity to aquatic
organisms to occur at a concentration of 30 ppb PMN substance in
surface waters.
Recommended testing: The results of a 90-day subchronic inhalation
toxicity study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997)
(FRL-5719-5) and a 2-year, two-species bioassay via inhalation (40 CFR
799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help
characterize the human health concerns. The results of a fish acute
toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid
acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal
acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) conducted
using static method and nominal concentrations, would help to
characterize the toxicity of the substance. 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 toxicity test. The PMN submitter has also agreed not to
exceed the second higher production volume limit without performing the
bioassay.
CFR citation: 40 CFR 721.5549.
PMN Number P-96-33
Chemical name: Cyclopropanecarboxaldehyde.
CAS number: 1489-69-6.
Effective date of section 5(e) consent order: November 27, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Similar aldehydes have been shown to cause lung
irritation, carcinogenicity, mutagenicity, and liver toxicity in test
animals. Developmental effects are possible based on the acid.
Recommended testing: EPA has determined that an in vitro mouse lymphoma
assay (40 CFR 799.9530) (62 FR 43846, August 15, 1997) (FRL-5719-5) and
an in vivo mouse micronucleus assay (40 CFR 799.9539) (62 FR 43853,
August 15, 1997) (FRL-5719-5), a 90-day inhalation test in rats (OECD
guideline no. 413), a 2-year, one-species bioassay (40 CFR 799.9420)
(62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the
human health effects. The consent order contains two production volume
limits.
[[Page 3406]]
The PMN submitter has agreed not to exceed the first production volume
limit without performing the in vitro mouse lymphoma, in vivo mouse
micronucleus assays, and the 90-day inhalation test in rats. The PMN
submitter has also agreed not to exceed the second production volume
limit without performing a 2-year, one-species bioassay, which EPA may
elect not to require depending on the results of the mutagenicity
studies and the 90-day test.
CFR citation: 40 CFR 721.2280.
PMN Number P-96-92
Chemical name: (generic) 1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl)
and Bis(dimethylamino substituted) carbomonocycle.
CAS number: Not available.
Basis for action: The PMN substance will be used in a consumer article.
Based on analogy to hydroquinones, 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.1155.
PMN Number P-96-93
Chemical name: Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-
methylethyl)]-.
CAS number: 16298-38-7.
Basis for action: The PMN substance will be used in a non-dispersive
use. Based on submitted test data 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.1105.
PMN Number P-96-236
Chemical name: 1-Tridecyn-3-ol, 3-methyl.
CAS Number: 100912-15-0.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy of the PMN substance to 1-hexyn-3-ol and other
structurally similar substances, EPA is concerned that liver toxicity,
kidney toxicity, neurotoxicity, reproductive toxicity, and
cardiotoxicity will occur to exposed workers. EPA determined that use
of the substance as described in the PMN did not present an
unreasonable risk because significant worker exposures were not
expected. EPA has determined that domestic manufacture of the substance
or use of the substance without dermal protective equipment may result
in significant worker exposures. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that an oral 2-generation
reproduction study in rats (40 CFR 799.9380) (62 FR 43834, August 15,
1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR
798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522,
June 20, 1996) (FRL-5367-7)) would help characterize the health effects
of the PMN substance.
CFR citation: 40 CFR 721.9830.
PMN Number P-96-238
Chemical name: (generic) Azo monochloro triazine reactive dye.
CAS number: Not available.
Basis for action: The PMN substance will be used as a dye. Based on
analogy to structurally similar substances and submitted test data, EPA
is concerned that liver toxicity, blood toxicity, oncogenicity,
neurotoxicity, and developmental toxicity will occur in exposed
workers. EPA determined that use of the substance did not present an
unreasonable risk because significant worker exposure is not expected
because the substance was manufactured, processed, or used as liquids.
EPA has determined that manufacture, processing, or use of the
substance as a solid may result in significant worker exposure. Based
on this information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that an oral two-species
developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15,
1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR
798.2650 or OPPT 870.3100 test guideline (public draft; 61 FR 31522,
June 20, 1996) (FRL-5367-7)) would help characterize the health effects
of the PMN substance.
CFR citation: 40 CFR 721.9717.
PMN Number P-96-273
Chemical name: (generic) Chloroalkane.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on toxicity data submitted with the PMN and by analogy to
chlorinated solvents, EPA identified health concerns for liver
toxicity, kidney toxicity, neurotoxicity, and oncogenicity. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because significant human exposure is not
expected. EPA has determined that use of the substance other than as
described in the PMN may result in significant human exposure. Based on
this information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPT
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)) would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.2091.
PMN Number P-96-346
Chemical name: (generic) Aminofunctional alkoxy alkyl siloxane.
CAS number: Not available.
Basis for action: The PMN substance will be used as an adhesion
promoter.
[[Page 3407]]
Based on analogy to aliphatic amines and ethoxysilanes, 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.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance was not released
to surface waters. EPA has determined that other uses may result in
releases to surface waters above 10 ppb. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9515.
PMN Numbers P-96-399/400/401/402/403/404
Chemical name: (generic) Alkyl polycarboxylic acids, esters with
ethoxylated fatty alcohols, reaction products with maleic anhydride.
CAS number: Not available.
Basis for action: The PMN substances will be used as site-limited
production intermediates. Based on analogy to nonionic surfactants, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 9 ppb of the PMN substances in surface waters.
EPA determined that use of the substances as described in the PMNs did
not present an unreasonable risk because the substances were not
released to surface waters. EPA has determined that other uses may
result in releases to surface waters. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.6477.
PMN Numbers P-96-406/407/408
Chemical name: (generic) Alkyltri, tetra, and pentaamines.
CAS number: Not available.
Basis for action: The PMN substances will be used as industrial
lubricants and fuel additives. Based on 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 substances in surface waters.
EPA determined that use of the substances as described in the PMNs did
not present an unreasonable risk because the substances were not
released to surface waters. EPA has determined that other uses may
result in releases to surface waters. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.2350.
PMN Numbers P-96-554/555/556/557/558/559/560/561/564/565
Chemical name: (generic) Alkyl polycarboxylic acids, esters with
ethoxylated fatty alcohols.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on analogy to nonionic surfactants, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 20
ppb of the PMN substances in surface waters. EPA determined that use of
the substances as described in the PMN did not present an unreasonable
risk because the substances would not be released to surface waters.
EPA has determined that other uses of the substances may result in
releases to surface waters which exceed the concern concentration.
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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.6475.
PMN Number P-96-573
Chemical name: (generic) Ethoxylated alkyl quaternary ammonium
compound.
CAS Number: Not available.
Basis for action: The PMN substance will be used in an open dispersive
use. Based on analogy of the PMN substance to cationic surfactants, 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.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because there were no significant
environmental exposures. EPA has determined that any use of the
substance other than for the specific use described in the PMN may
result in significant environmental exposures. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.655.
PMN Number P-96-585
Chemical name: (generic) Salt of a substituted polyalkylenepolyamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid.
Based on 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance was not released to surface waters. EPA has
determined that other uses may result in
[[Page 3408]]
releases to surface waters. Based on this information the PMN substance
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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6197.
PMN Number P-96-702
Chemical name: (generic) Substituted phenyl azo substituted sulfo
carbopolycycle.
CAS number: Not available.
Basis for action: The PMN substance will be used in an open
nondispersive use. EPA determined that use of the substance as
described in the PMN did not present an unreasonable risk because it
did not result in significant human or environmental exposure. EPA has
determined that increased use of the substance may result in
significant environmental and human exposure.
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an activated sludge
adsorption isotherm (OPPTS 835.1110 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1) would help characterize the
environmental effects of the PMN substance. A murine immune allergic
response study (Toxicology and Applied Pharmacology 112:190-197 (1992))
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2122.
PMN Numbers P-96-767/773
Chemical name: (generic) Substituted pyridine azo substituted phenyl.
CAS number: Not available.
Basis for action: The PMN substances will be used as textile dyes.
Based on analogy to structurally similar substances, EPA is concerned
that liver toxicity, kidney toxicity, oncogenicity, blood toxicity,
neurotoxicity, and developmental toxicity will occur in exposed
workers. EPA determined that use of the substances did not present an
unreasonable risk because significant worker exposure is not expected
because the substances were not manufactured domestically. EPA has
determined that domestic manufacture of the substances may result in
significant worker exposure. Based on this information the PMN
substances meet the concern criteria at Sec. 721.170 (b)(1)(i)(C) and
(b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a two-species oral developmental toxicity study (40 CFR 799.9370) (62
FR 43832, August 15, 1997) (FRL-5719-5), and a subchronic oral study in
rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft;
61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the
health effects of the PMN substances.
CFR citation: 40 CFR 721.8780.
PMN Number P-96-795
Chemical name: (generic) Mixed fatty alkylamines, salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid.
Based on 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance was not released to surface waters. EPA has
determined that other uses may result in releases to surface waters.
Based on this information the PMN substance 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.567.
PMN Number P-96-813
Chemical name: (generic) Phenothiazine derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as a mediator in
enzyme catalyzed reactions. Based on analogy to phenothiazines and
submitted toxicity data, EPA is concerned that blood toxicity, liver
toxicity, kidney effects, adrenal toxicity, spleen toxicity,
reproductive toxicity, and neurotoxicity will occur in exposed workers.
Based on submitted test data EPA is also concerned that toxicity to
aquatic organisms will occur at concentrations as low as 7 ppb. EPA
determined that use of the substance did not present an unreasonable
risk because the use as described in the PMN would not result in
significant worker exposure or environmental release. EPA has
determined that domestic manufacture of the substance as a powder may
result in significant worker exposure or environmental release. Based
on this information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a
chronic 60-day fish early life stage toxicity test in rainbow trout (40
CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic
toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public
draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help
characterize the health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5913.
PMN Number P-96-824
Chemical name: (generic) Acrylate ester.
CAS number: Not available.
Basis for action: The PMN substance will be used as a monomer. Based on
analogy to acrylates, EPA identified concerns for toxicity to aquatic
organisms at concentrations as low as 6 ppb. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because significant environmental exposure is not expected. EPA
has determined that other uses may result in releases to water which
are significant environmental exposures. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test
[[Page 3409]]
guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)),
and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400
test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
1)) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.2805.
PMN Number P-96-866
Chemical name: (generic) Derivative of substituted carbomonocyclic
carboxylic acid-amine distillation stream byproduct reaction product.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid.
Based on 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance was not released to surface waters. EPA has
determined that other uses may result in releases to surface waters.
Based on this information the PMN substance 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.2082.
PMN Number P-96-897
Chemical name: (generic) Terpene residue distillates.
CAS number: Not available.
Basis for action: The PMN substance will be used as an odor enhancer.
Based on analogy to neutral organic substances, 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. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because the substance would not be released to surface waters
above a level of 10 ppb. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9635.
PMN Number P-96-941
Chemical name: (generic) Ceteareth-25 sorbate.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to nonionic surfactants, 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. EPA determined that use of
the substance as an intermediate did not present an unreasonable risk
because the substance would not be released to surface waters in
significant amounts. EPA has determined that other uses of the
substance may result in releases to surface waters which significantly
exceed the concern concentration. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.2145.
PMN Number P-96-942
Chemical name: Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-
(1,1,3,3- tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-
(octyloxy)phenyl]phenyl-.
CAS number: 162245-07-0.
Effective date of section 5(e) consent order: September 24, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health. Toxicity concern: Section 8(e) data and data on analogous
hindered phenol benzotriazoles have shown similiar substances to cause
increased organ weight (liver and kidney, with associated
histopathology at higher doses); hematological effects (decreased
hemoglobin, packed cell volume, and erythrocytes); and immune systems
effects(weight changes in thymus, spleen, lymph nodes; decreased
leukocytes) in test animals.
Recommended testing: EPA has determined that a 90-day gavage study in
rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft;
61 FR 31522, June 20, 1996) (FRL-5367-7)) with special attention to
hematology would help characterize systemic toxicity and reproductive
toxicity. The PMN submitter has agreed not to exceed the production
volume limit without performing this test.
CFR citation: 40 CFR 721.4885.
PMN Numbers P-96-945/946/947/948
Chemical name: (generic) Mixture of hydrochlorofluoro alkanes and
hydrochlorofluoro alkene.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on analogy to similar substances, EPA is concerned that lung
toxicity, neurotoxicity, irritation, oncogenicity, liver toxicity,
kidney toxicity, and cardiac sensitization will occur in exposed
workers. EPA determined that use of the substance as an intermediate
did not present an unreasonable risk because it did not result in
significant worker exposure. EPA has determined that use other than an
intermediate may result in significant worker exposure. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two-
species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997)
(FRL-5719-5) would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.4464.
PMN Numbers P-96-950/951
Chemical name: (generic) Polymers of C13C15
oxoalcohol ethoxolate, ammonia, and maleic anhydride.
[[Page 3410]]
CAS number: Not available.
Basis for action: The PMN substances will be used as described in the
PMN. Based on structure activity relationships to nonionic surfactants-
alkylethoxylates, EPA is concerned that toxicity to aquatic organisms
may occur at a concentration as low as 9 ppb of the PMN substances in
surface waters. EPA determined that use of the substances as described
in the PMNs did not present an unreasonable risk because the substances
would not be released to surface waters. EPA has determined that other
uses of the substances may result in releases to surface waters which
exceed the concern concentration. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.6505.
PMN Number P-96-1176
Chemical name: Cyclohexanamine, N,N-dimethyl-, compd. with alpha-
isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.
CAS Number: 164383-18-0.
Basis for action: The PMN substance will be used as a pigment
dispersant for color dispersion. Based on analogy to phosphate based
anionic surfactants, EPA expects toxicity to aquatic organisms at
surface water concentrations as low as 20 ppb. EPA determined that use
of the substance as described in the PMN did not present an
unreasonable risk because there were no significant environmental
exposures. EPA has determined that any use of the substance other than
for the specific use described in the PMN may result in significant
exposures. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance
CFR citation: 40 CFR 721.2222.
PMN Number P-96-1177
Chemical name: Tungstate (W12(OH)2O386-) hexasodium (9CI).
CAS Number: 12141-67-2.
Basis for action: The PMN substance will be used in an open non-
dispersive use. Based on submitted test data, EPA is concerned that
hepatotoxicity, kidney toxicity, neurotoxicity, reproductive toxicity,
eye and skin irritation, and toxicity to the GI tract, spleen, lungs,
pancreas, urinary bladder, and the lymph system may occur. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because there were no significant
inhalation exposures. EPA has determined that any use of the substance
other than for the specific use described in the PMN may result in
significant inhalation exposures. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or
OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20,
1996) (FRL-5367-7)) would help characterize the health effects of the
PMN substance.
CFR citation: 40 CFR 721.9840.
PMN Number P-96-1216
Chemical name: Benzoic acid, 3-amino-, diazotized, coupled with 6-
amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3-
aminophenyl)phosphonic acid and diazotized 2,5-diethoxybenzenamine.
CAS number: 163879-69-4.
Basis for action: The PMN substance will be used as a coloring
material. Based on submitted toxicity data on the PMN substance and
analogy to the azo reduction products, EPA is concerned that eye
irritation, skin sensitization, reproductive toxicity in males, blood
toxicity, liver toxicity, kidney toxicity, reproductive toxicity,
spleen effects, oncogenicity, neurotoxicity, and developmental toxicity
will occur in workers exposed via inhalation. EPA determined that use
of the substance as described in the PMN does not present an
unreasonable risk. Significant worker inhalation exposure is not
expected because the substance will not be manufactured, processed, or
used as a powder. EPA has determined that manufacture, processing, and
use of the substance as a powder may result in significant worker
inhalation exposure. Based on this information the PMN substance meets
the concern criteria at Sec. 721.170 (b)(1)(i)(D), (b)(3)(i), and
(b)(3)(iii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 2-generation reproductive toxicity study (40 CFR 799.9380) (62 FR
43834, August 15, 1997) (FRL-5719-5) would help characterize the human
health effects of the PMN substance.
CFR citation: 40 CFR 721.1705.
PMN Number P-96-1233
Chemical name: (generic) Reaction product of epoxy with anhydride and
glycerol and glycol.
CAS number: Not available.
Basis for action: The PMN substance will be used as molding compound.
Based on analogy to diepoxides and 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. Based on analogy to similar
substances there is concern for oncogenicity, developmental toxicity,
reproductive toxicity, and neurotoxicity to exposed workers. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because the substance would not be
released to surface waters and workers would not be exposed by
inhalation. EPA has determined that other uses or uses as a powder may
result in releases to surface waters which exceed the concern
concentration or inhalation exposure to workers. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(c), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. EPA has also determined
that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR
43838, August 15, 1997) (FRL-
[[Page 3411]]
5719-5), a 90-day subchronic inhalation study in rats (40 CFR 798.2650
or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20,
1996) (FRL-5367-7)), and a two-species oral developmental toxicity test
(40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9270.
PMN Number P-96-1239
Chemical name: (generic) Aliphatic polyisocyanate homopolymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to structurally similar substances, EPA is concerned
that pulmonary sensitization and irritation will occur in exposed
workers. EPA determined that use of the substance did not present an
unreasonable risk because significant worker exposure is not expected
because the substance was used as an intermediate. EPA has determined
that use other than an intermediate may result in significant worker
exposure. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day inhalation study
in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.4259.
PMN Number P-96-1240
Chemical name: Poly(oxy-1,2-ethanediyl), -sulfo--[1-
[(4-nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, ammonium
salts.
CAS number: 184719-88-8.
Basis for action: The PMN substance will be used as an emulsifier.
Based on analogy to structurally similar substances and submitted test
data, EPA is concerned that kidney toxicity, reproductive toxicity,
developmental toxicity, and oncogenicity will occur in exposed workers.
EPA determined that use of the substance did not present an
unreasonable risk because significant worker exposure is not expected
because the substance was not manufactured domestically. EPA has
determined that domestic manufacture of the substance may result in
significant worker exposure. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C),
(b)(3)(i), (b)(3)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a two-species oral developmental toxicity test (40 CFR 799.9370) (62 FR
43832, August 15, 1997) (FRL-5719-5), and a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.539.
PMN Number P-96-1263
Chemical name: (generic) Substituted phenyl azo substituted
sulfocarbopolycle, sodium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used in a destructive use.
Based on analogy to structurally similar substances, EPA is concerned
that oncogenicity, blood effects, developmental toxicity, and
neurotoxicity will occur in workers exposed via inhalation. EPA
determined that use of the substance as described in the PMN does not
present an unreasonable risk. Significant worker inhalation exposure is
not expected because the substance will not be manufactured, processed,
or used as a powder. EPA has determined that manufacture, processing,
and use of the substance as a solid may result in significant worker
inhalation exposure. Based on this information the PMN substance meets
the concern criteria at Sec. 721.170(b)(3)(iii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)), and a two-species oral developmental toxicity test (40
CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9545.
PMN Numbers P-96-1280/1281/1504/1505/1506/1507/1508
Chemical name: (generic) Quaternary ammonium alkyletherpropyl
trialkylamine halides.
CAS number: Not available.
Basis for action: The PMN substances will be used as industrial
production aids. Based on analogy to aliphatic amines and cationic
surfactants, EPA is concerned that toxicity to aquatic organisms may
occur at a concentration as low as 2 ppb of the PMN substances in
surface waters. EPA determined that use of the substances as described
in the PMN did not present an unreasonable risk because the substances
would not be released to surface waters. EPA has determined that other
uses of the substances may result in releases to surface waters which
exceed the concern concentration. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.4095.
PMN Number P-96-1288
Chemical name: (generic) Hydrofluoroalkene.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to structurally similar substances, EPA is concerned
that lung toxicity, neurotoxicity, irritation, oncogenicity, liver
toxicity, kidney toxicity, and cardiac sensitization will occur in
exposed workers. EPA determined that use of the substance as an
intermediate did not present an unreasonable risk because it did not
result in significant worker exposure. EPA has determined that use
other than an intermediate may result in significant worker exposure.
Based on this information the PMN substance meets the concern criteria
at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two-
species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997)
(FRL-5719-5) would help characterize the health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.4465.
PMN Number P-96-1315
Chemical name: 9H-Thioxanthen-9-one, 2,4-diethyl.
CAS number: 82799-44-8.
[[Page 3412]]
Basis for action: The PMN substance will be used as a
photopolymerization initiator. Based on analogy to neutral organic
substances, 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. EPA determined that use of the substance as described
in the PMN did not present an unreasonable risk because the substance
would not be released to surface waters in significant quantities. EPA
has determined that other uses of the substance may result in releases
to surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9664.
PMN Number P-96-1319
Chemical name: (generic) Nitro methyl quinoline.
CAS number: Not available.
Basis for action: The PMN substance will be used in a destructive use.
Based on analogy to structurally similar substances, there is concern
for oncogenicity, mutagenicity, blood toxicity, and neurotoxicity. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because the substance would not be
released to surface waters in significant amounts and workers would not
be exposed by inhalation. EPA has determined that use without
appropriate respiratory protection may result in significant inhalation
exposure to workers and disposal other than by incineration may result
in significant drinking water exposures to exposed populations. 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 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or
OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20,
1996) (FRL-5367-7)) would characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.9080.
PMN Numbers P-96-1337/1338/1339
Chemical name: (generic) Amine substituted metal salts.
CAS number: Not available.
Basis for action: The PMN substances will be used as catalysts. Based
on analogy to structurally similar compounds, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 4
ppb of the PMN substances in surface waters. EPA determined that use of
the substances as described in the PMN did not present an unreasonable
risk because the substances would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.640.
PMN Number P-96-1410
Chemical name: (generic) Substituted bisaniline.
CAS number: Not available.
Basis for action: The PMN substance will be used as paper dye
intermediate. Based on analogy to neutral organics, 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. EPA determined that
use of the substance as described in the PMN did not present an
unreasonable risk because the substance would not be released to
surface waters in significant quantities. EPA has determined that other
uses of the substance may result in releases to surface waters which
exceed the concern concentration. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.1805.
PMN Number P-96-1427
Chemical name: (generic) Stilbene diglycidyl ether.
CAS number: Not available.
Effective date of section 5(e) consent order: March 14, 1997.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health.
Toxicity concern: Diglycidyl ether of bisphenol A (DGEBA), other
similar chemicals, and epoxides have been shown to cause mutagenicity,
oncogenicity, male reproductive toxicity and mucous membrane irritation
in test animals.
Recommended testing: EPA has determined that a 90-day subchronic oral
toxicity study with attention to the male and female reproductive
organs (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft;
61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to characterize
the reproductive toxicity. The PMN submitter has agreed not to exceed
the production volume limit without performing this test. A 2-year
bioassay on bisphenol A-diglycidyl ether (40 CFR 799.9420) (62 FR
43838, August 15, 1997) (FRL-5719-5) would be required to evaluate the
carcinogenicity effects which may be caused by the PMN substance. This
study will serve as a surrogate for a carcinogenicity study on the PMN
substance. The order does not require submission of the oncogenicity
study 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 study or other relevant information.
CFR citation: 40 CFR 721.3465.
[[Page 3413]]
PMN Number P-96-1430
Chemical name: (generic) Alkylpoly(oxyalkylene)amine.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to aliphatic amines EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 10 ppb of the
PMN substance in surface waters. EPA determined that use of the
substance as an intermediate did not present an unreasonable risk
because it did not result in significant environmental exposure. EPA
has determined that use other than an intermediate may result in
significant environmental exposure. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.641.
PMN Number P-96-1478
Chemical name: (generic) Ethoxylated alcohol, phosphated, amine salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymer
suspension agent. Based on analogy to phosphate ester surfactants EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 8 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because significant releases of the
substance is not expected to surface waters. EPA has determined that
other uses of the substance may result in releases to surface waters
which exceed the concern concentration. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.643.
PMN Numbers P-96-1510/1511/1512/1513/1514
Chemical name: (generic) Alkyletherpropyl dialkylamine.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on 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 substances in surface waters. EPA determined that use of the
substances as described in the PMN did not present an unreasonable risk
because there was not significant releases of the substances to surface
waters. EPA has determined that uses other than as an intermediate may
result in releases to surface waters which exceed the concern
concentration. 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.2345.
PMN Number P-96-1536
Chemical name: 2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.
CAS number: 153954-47-3.
Basis for action: The PMN substance will be used as a crosslinker in a
polymerization reaction. Based on analogy to structurally similar
chemicals, EPA identified health concerns for oncogenicity,
mutagenicity, neurotoxicity, and developmental toxicity. EPA determined
that use of the substance as described in the PMN did not present an
unreasonable risk because significant human exposure is not expected.
EPA has determined that use of the substance without impervious gloves
may result in significant human exposure. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C)
and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a two-species oral developmental toxicity test (40 CFR 799.9370)
(62 FR 43832, August 15, 1997) (FRL-5719-5) will address the potential
health effects of the PMN substance as there is concern and potential
from all routes of exposure.
CFR citation: 40 CFR 721.9010.
PMN Number P-96-1588
Chemical name: (generic) Hydrochloride salt of a mixed fatty
amidoamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid.
Based on 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance was not released to surface waters. EPA has
determined that other uses may result in releases to surface waters.
Based on this information the PMN substance 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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.637.
PMN Number P-96-1649
Chemical name: (generic) Modified silicone resin.
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymerization
initiator. Based on analogy to neutral organic chemicals, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 5 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
[[Page 3414]]
released to surface waters in significant quantities. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. 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 chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9499.
PMN Number P-96-1652
Chemical name: Phosphinothioic acid, bis(2,4,4-trimethylpentyl)- (9Cl).
CAS number: 132767-86-3.
Basis for action: The PMN substance will be used as a solvent
extraction reagent. Based on analogy to phosphate-based dialkyl anionic
surfactants and neutral organics, 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. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6045.
PMN Numbers P-96-1661/95-1654
Chemical name: (generic) Alkoxysilane ester.
CAS number: Not available.
Basis for action: The PMN substance will be used in coatings and as a
filler. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because it did not result in
significant human exposure. EPA has determined that increased use of
the substance may result in significant human exposure.
Recommended testing: EPA has determined that a 90-day subchronic
inhalation toxicity study in rats (40 CFR 799.9346) (62 FR 43828,
August 15, 1997) (FRL-5719-5) would help characterize the health
effects of the PMN substance.
CFR citation: 40 CFR 721.537.
PMN Numbers P-97-57/58/59/60/61
Chemical name: (generic) Alkyl substituted quaternary ammonium
chloride.
CAS number: Not available.
Basis for action: The PMN substances will be used as surface active
agents. Based on submitted test data and analogy to monoalkyl
quaternary surfactants EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 4 ppb of the PMN
substances in surface waters. EPA determined that use of the substances
as described in the PMNs did not present an unreasonable risk because
the substances would not be released to surface waters during
manufacturing and processing. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meet the concern criteria at Sec. 721.170 (b)(4)(i) and (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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.658.
PMN Number P-97-131
Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'[[2-amino-
4-[(3-butoxy-2-hydroxypropyl)amino]phenyl]azo]-3,3'-dimethyl[1,1'-
biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt.
CAS number: 103580-64-9.
Basis for action: The PMN substance will be used in ball point pen ink.
Based on potential dimethylbenzidine, aniline, and triaminobenzene azo
reduction products there is concern for oncogenicity, mutagenicity,
developmental toxicity, liver toxicity, blood toxicity, and
neurotoxicity. EPA determined that use of the substance as described in
the PMN did not present an unreasonable risk because the substance
would not be released to surface waters in significant amounts and
workers would not be exposed by inhalation. EPA has determined that
domestic manufacture, use as a powder, or additional releases to
surface water may result in drinking water exposure or inhalation
exposure to workers. Based on this information the PMN substance meets
the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)), and a two-species oral developmental toxicity test (40
CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.5279.
PMN Number P-97-136
Chemical name: (generic) Alkoxylated fatty acid amide alkylsulfate
salt.
CAS number: Not available.
Basis for action: The PMN substance will be used to soften cellulose.
Based on analogy to dialkyl cationic surfactants EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 2
ppb of the PMN substance in surface waters. EPA determined that
industrial uses of the substance did not present an unreasonable risk
because it did not result in significant environmental exposure. EPA
has determined that non-industrial uses may result in significant
environmental exposure. 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;
61 FR 16486, April 15, 1996) (FRL-5363-
[[Page 3415]]
1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010
test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-
1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS
850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996)
(FRL-5363-1)) would help characterize the environmental effects of the
PMN substance.
CFR citation: 40 CFR 721.720.
PMN Numbers P-97-143/144
Chemical name: (generic) Polymers of styrene, cyclohexyl methacrylate
and substituted methacrylate.
CAS number: Not available.
Basis for action: The PMN substances will be used as coating resins.
Based on analogy to structurally similar substances, there is concern
for oncogenicity, mutagenicity, reproductive toxicity in males,
developmental toxicity, lung and skin sensitization, and membrane
irritation. EPA determined that use of the substances as described in
the PMN did not present an unreasonable risk because significant worker
exposure is not expected. EPA has determined that domestic manufacture
may result in significant inhalation exposure to workers. Based on this
information the PMN substances meets the concern criteria at
Sec. 721.170(b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)), and a two-species oral developmental toxicity test (40
CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would
characterize the human health effects of the PMN substances.
CFR citation: 40 CFR 721.9492.
PMN Number P-97-193
Chemical name: 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-,
coupled with diazotized 4-butylbenzenamine, diazotized 4,4'-
cyclohexylidenebis[benzenamine] and m-phenylenediamine, sodium salt.
CAS number: 182238-09-1.
Basis for action: The PMN substance will be used in ink. Based on
potential aniline and triaminobenzene azo reduction products and
submitted test data, there is concern for oncogenicity, mutagenicity,
and blood toxicity. EPA determined that use of the substance as
described in the PMN did not present an unreasonable risk because
workers would not be exposed by inhalation. EPA has determined that
domestic manufacture and use as a powder, may result in inhalation
exposure to workers. Based on this information the PMN substance meets
the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5)
and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or
OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20,
1996) (FRL-5367-7)) would characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.5280.
PMN Number P-97-217
Chemical name: 1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
CAS number: 931-35-1.
Basis for action: The PMN substance will be used as an epoxy catalyst.
Based on analogy to aliphatic amines, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 40 ppb of the
PMN substance in surface waters. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because the substance would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.4468.
PMN Number P-97-264
Chemical name: Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluorodecyl)trimethoxy-.
CAS number: 83048-65-1.
Basis for action: The PMN substance will be used in coatings, plastics,
and greases. Based on analogy to alkoxysilanes, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 10
ppb of the PMN substance in surface waters. Based on analogy to
alkoxysilanes and perfluoro compounds, there is concern for lung
toxicity, irritation to mucuous membranes, liver toxicity, blood
toxicity, immunosuppression, and reproductive toxicity. EPA determined
that use of the substance as described in the PMN did not present an
unreasonable risk because the substance would not be released to
surface waters and workers would not be exposed by inhalation. EPA has
determined that other uses of the substance may result in inhalation
exposures to workers and releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance meet
the concern criteria at Sec. 721.170 (b)(3)(ii) and (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;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. EPA has also determined
that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR
43838, August 15, 1997) (FRL-5719-5), a 90-day subchronic inhalation
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), and an oral
reproductive toxicity test in rats (40 CFR 799.9380) (62 FR 43834,
August 15, 1997) (FRL-5719-5) would help characterize the health
effects of the PMN substance.
CFR citation: 40 CFR 721.9503.
PMN Number P-97-302
Chemical name: Hexadecanoic acid, ethenyl ester.
CAS number: 693-38-9.
Basis for action: The PMN substance will be used as a component in
adhesive formulations. Based on analogy to vinyl acetate and other
similar substances, there is concern for neurotoxicity, mutagencity,
oncogenicity, liver toxicity, developmental toxicity and reproductive
toxicity. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because workers would not be
subject to significant exposures. EPA has determined that other use of
the substance may result in significant exposures to workers. Based on
this information the PMN substance
[[Page 3416]]
meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year, two-species oral
bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5),
a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS
870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996)
(FRL-5367-7)), an oral two-species developmental toxicity test (40 CFR
799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5), and an oral
reproductive toxicity test in rats (40 CFR 799.9380) (62 FR 43834,
August 15, 1997) (FRL-5719-5) would help characterize the health
effects of the PMN substance.
CFR citation: 40 CFR 721.4158.
PMN Number P-97-304
Chemical name: (generic) Disubstituted thiadiazolsulfone.
CAS number: Not available.
Basis for action: The PMN substance will be used in an enclosed use.
Based on analogy to N-heterocycles there are concerns for developmental
toxicity. Based on submitted toxicity data there are concerns for
neurotoxicity, mutagenicity, and irritation to eyes, lungs, and mucous
membranes . EPA determined that use of the substance as described in
the PMN did not present an unreasonable risk because workers would not
be subject to significant exposures. EPA has determined that uses of
the substance in a non-enclosed process and other than for the specific
use designated in the PMN may result in significant exposures to
workers. Based on this information the PMN substance meet the concern
criteria at Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a two-species oral
developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15,
1997) (FRL-5719-5) would characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.9659.
PMN Number P-97-314
Chemical name: (generic) Disubstituted thiadiazole.
CAS number: Not available.
Basis for action: The PMN substance will be used in an enclosed use.
Based on analogy to N-heterocycles there are concerns for developmental
toxicity. Based on submitted toxicity data there are concerns for
neurotoxicity, mutagenicity, and irritation to eyes, lungs, and mucous
membranes. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because workers would not be
subject to significant exposures. EPA has determined that uses of the
substance in a non-enclosed process and other than for the specific use
designated in the PMN may result in significant exposures to workers.
Based on this information the PMN substance meet the concern criteria
at Sec. 721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public
draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a two-species oral
developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15,
1997) (FRL-5719-5) would characterize the human health effects of the
PMN substance.
CFR citation: 40 CFR 721.9657.
PMN Number P-97-328
Chemical name: (generic) Ethylenediamine, substituted, sodium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on analogy to polyanionic monomers and n-halo-nitro compounds,
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.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because significant releases of the
substance is not expected to surface waters. EPA has determined that
uses other than as an intermediate may result in releases to surface
waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.3565.
PMN Number P-97-417
Chemical name: (generic) Potassium salt of polyolefin acid.
CAS number: Not available.
Basis for action: The PMN substance will be used as a fuel additive.
Based on analogy to fatty acid anionic surfactants, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 800 ppb of the PMN substance in surface waters. EPA determined that
use of the substance as described in the PMN did not present an
unreasonable risk because significant releases of the substance is not
expected to surface waters. EPA has determined that uses other than as
a fuel additive may result in releases to surface waters which exceed
the concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.7375.
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 25 of the 163
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 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) orders.
In the other 138 cases for which the proposed uses are not
regulated under a TSCA section 5(e) 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,
[[Page 3417]]
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) 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 direct final rules, 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 23, 1998, unless
EPA receives a written notice by February 23, 1998 that someone wishes
to make adverse or critical comments on EPA's action. If EPA receives
such a notice, EPA will publish a notice 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) 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) 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 orders
required submissions at least 12 weeks) before reaching the specified
production limit. Listings of the tests specified in the TSCA section
5(e) 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 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) orders have
been issued for 24 substances and notice submitters are prohibited by
the TSCA section 5(e) orders from undertaking activities which EPA is
designating as significant new uses. In cases where EPA has not
received a NOC and the substance has not been added to the TSCA
Inventory, no other person may commence such activities without first
submitting a PMN. For substances for which an NOC has not been
submitted
[[Page 3418]]
at this time, EPA has concluded that the uses are not ongoing. However,
EPA recognizes in cases when chemical substances identified in this
SNUR are added to the TSCA Inventory prior to the effective date of the
rule, the 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, 123 of the 163 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) 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 public record for this
rule (OPPTS-50628).
X. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-50628 (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 12 noon to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located in the TSCA
Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW.,
Washington, DC.
Electronic comments can be sent directly to EPA at:
oppt.ncic@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect in 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-50628. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
The OPPTS harmonized test guidelines referenced in this document
are available on EPA's World Wide Web site under ``Researchers and
Scientists,'' ``Environmental Test Methods & Guidelines'' (http://
www.epa.gov/epahome/research.htm).
XI. Regulatory Assessment Requirements
Under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB). In addition, this action does not impose
any enforceable duty or contain any unfunded mandate as described in
the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4), or
require prior consultation with State officials as also specified in
Executive Order 12875, entitled ``Enhancing the Intergovernmental
Partnership'' (58 FR 58093, October 28, 1993). Nor does it 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), or additional OMB review
in accordance with Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997).
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 rules,
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,
OPPE Regulatory Information Division, U.S. Environmental Protection
Agency (Mail Code 2137), 401 M Street, S.W., Washington, D.C. 20460,
with a copy to the Office of Information and Regulatory Affairs, Office
of Management and Budget, 725 17th St., N.W., Washington, DC 20503,
marked ``Attention: Desk Officer for EPA.'' Please remember to include
the OMB control number in any correspondence, but do not submit any
completed forms to these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously
certified, as a generic matter, that the promulgation of a SNUR does
not have a significant adverse economic impact on a substantial number
of small entities. The Agency's generic certification for promulgation
of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1), and
was provided to the Chief Counsel for Advocacy of the Small Business
Administration.
XII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required
[[Page 3419]]
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the General Accounting Office prior to
publication of this rule in today's Federal Register. This 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: January 6, 1998.
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. 721.405 to subpart E to read as follows:
Sec. 721.405 Polyether acrylate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polyether acrylate (PMN P-95-666) 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.
3. By adding new Sec. 721.524 to subpart E to read as follows:
Sec. 721.524 Alcohols, C6-12, ethoxylated, reaction
product with maleic anhydride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alcohols, C6-12, ethoxylated, reaction product with maleic
anhydride (PMN P-88-1108) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 300).
(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.
4. By adding new Sec. 721.526 to subpart E to read as follows:
Sec. 721.526 Substituted aromatic aldehyde.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted aromatic aldehyde (PMN P-95-1466) 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.
5. By adding new Sec. 721.528 to subpart E to read as follows:
Sec. 721.528 Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzaldehyde, 2-
hydroxy-5-nonyl-, oxime, branched (PMN P-95-1467; CAS No. 174333-80-3)
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 this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
6. By adding new Sec. 721.537 to subpart E to read as follows:
Sec. 721.537 Organosilane ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
organosilane ester (PMN P-96-1661/P-95-1654) 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(r) (370,000 kilogram (kg)) (90-day
subchronic inhalation study in rats-(40 CFR 799.9346) (62 FR 43828,
August 15, 1997) (FRL-5719-5). 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)(i)(A), (a)(2)(i)(B),
(a)(2)(i)(C), and (a)(2)(i)(D) of this section.
(A) Each study required to be performed pursuant to this section
must be scientifically valid. Scientific valid means that the study was
conducted according to:
(1) The test guidelines specified in paragraph (a)(2)(i) 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)(i) 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)(i) of this section (e.g.,
40 CFR part 797 or part 798) provide
[[Page 3420]]
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)(i)(D)(2) of this
section, if, within 6 weeks of EPA's receipt of a test report and data,
the person receives written notice that EPA finds that the data
generated by a study are scientifically invalid, the person is
prohibited from further manufacture and import of the PMN substance
beyond the applicable production volume limit.
(2) The person may continue to manufacture and import the PMN
substance beyond the applicable production limit only if so notified,
in writing, by EPA in response to the person's compliance with either
of the following paragraphs (a)(2)(i)(D)(2)(i) or (a)(2)(i)(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)(i)(C)(3) of this section, the person shall comply with paragraph
(a)(2)(i)(C)(3) of this section. If there is insufficient time for the
person to comply with paragraph (a)(2)(ii)(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)(i)(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)(i)(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)(i) of this section if notified in writing by EPA that
it is unnecessary to conduct that study.
(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.
7. By adding new Sec. 721.538 to subpart E to read as follows:
Sec. 721.538 Phenol, 4-(1,1-dimethylethyl)-, homopolymer.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 4-(1,1-
dimethylethyl)-, homopolymer (PMN P-95-243; CAS No. 30813-81-1) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(3) of this section.
(2) High moleculation weight exemption. A batch of the chemical
substance may be exempt from the provisions of this rule if the average
number molecular weight of the substance is greater than 1,000 and the
low molecular weight species below 1,000 and 500 are less than 25
percent and 10 percent, respectively. To be eligible for this
exemption, the batch must be individually measured.
(3) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (d), (f), (g)(3)(i), (g)(4)(i), and (g)(5). The
label and material safety data sheet (MSDS) as required by this
paragraph shall also include the following statement: This substance is
toxic to aquatic invertebrate.
(ii) Industrial, commercial, and consumer activites. Requirements
as specified in Sec. 721.80(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4) and (b)(4) (N = 9). When calculating the surface water
concentrations according to the instructions in Sec. 721.91, the
statement that the amount of the substance that will be released will
be calculated before the substance enters control technology does not
apply. Instead, if the waste stream containing the substance will be
treated using primary and secondary wastewater treatment with control
of suspended solids, before release, then the amount of the substance
reasonably likely to be removed from the waste stream by such treatment
may be subtracted in calculating the number of kilograms released. No
more than 95 percent removal efficiency may be attributed to such
treatment. These requirements do not apply to the sites specifically
exempted in the TSCA section 5(e) consent order for this substance.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (f), (g), (h), (i), and (k) are applicable
to manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
8. By adding new Sec. 721.539 to subpart E to read as follows:
Sec. 721.539 Poly(oxy-1,2-ethanediyl), -sulfo--[1-
[(4-nonylphenoxy)methyl]-2-(2-propenyloxy)ethoxy]-, branched, ammonium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Poly(oxy-1,2-
ethanediyl), -sulfo--[1-[(4-nonylphenoxy)methyl]-2-
(2-propenyloxy)ethoxy]-, branched, ammonium salts (PMN P-96-1240; CAS
No. 184719-88-8) 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) 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) 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.
9. By adding new Sec. 721.567 to subpart E to read as follows:
Sec. 721.567 Mixed fatty alkylamines, salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as mixed fatty
alkylamines (PMN P-96-795) is subject to reporting under this
[[Page 3421]]
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.
10. By adding new Sec. 721.637 to subpart E to read as follows:
Sec. 721.637 Hydrochloride salt of a mixed fatty amidoamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydrochloride salt of a mixed fatty amidoamine (PMN P-96-1588) 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.
11. By adding new Sec. 721.640 to subpart E to read as follows:
Sec. 721.640 Amine substituted metal salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as amine
substituted metal salts (PMNs P-96-1337/1338/1339) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 4).
(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.
12. By adding new Sec. 721.641 to subpart E to read as follows:
Sec. 721.641 Alkylpoly(oxyalkylene)amine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
alkylpoly(oxyalkylene)amine (PMN P-96-1430) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
13. By adding new Sec. 721.643 to subpart E to read as follows:
Sec. 721.643 Ethoxylated alcohol, phosphated, amine salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as an ethoxylated
alcohol, phosphated, amine salt (PMN P-96-1478) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 8).
(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.
14. By adding new Sec. 721.655 to subpart E to read as follows:
Sec. 721.655 Ethoxylated alkyl quaternary ammonium compound.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
ethoxylated alkyl quaternary ammonium compound (PMN P-96-573) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) 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.
15. By adding new Sec. 721.658 to subpart E to read as follows:
Sec. 721.658 Alkyl substituted quaternary ammoniums.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
substituted quaternary ammoniums (PMNs P-97-57/58/59/60/61) are subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(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.
[[Page 3422]]
16. By adding new Sec. 721.720 to subpart E to read as follows:
Sec. 721.720 Alkoxylated fatty acid amide, alkylsulfate salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
alkoxylated fatty acid amide, alkylsulfate salt (PMN P-97-136) 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(l).
(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.
17. By adding new Sec. 721.723 to subpart E to read as follows:
Sec. 721.723 Anthraquinone dye.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
anthraquinone dye (PMN P-94-2159) 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.
18. By adding new Sec. 721.977 to subpart E to read as follows:
Sec. 721.977 Aryloxyarene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aryloxyarene (PMN P-92-314) 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)(3)(ii), (g)(4)(iii), and
(g)(5). The label and MSDS as required by this paragraph shall also
include the following statement: This substance may be toxic to
sediment organisms.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (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.
19. By adding new Sec. 721.980 to subpart E to read as follows:
Sec. 721.980 Sodium salt of azo acid dye.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
sodium salt of azo acid dye (PMN P-95-633) is subject to eporting 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.
20. By adding new Sec. 721.981 to subpart E to read as follows:
Sec. 721.981 Substituted naphtholoazo-substituted naphthalenyl-
substituted azonaphthol chromium complex.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted naphtholoazo-substituted naphthalenyl-substituted
azonaphthol chromium complex (PMN P-93-1631) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(2), (w)(2), and (x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
21. By adding new Sec. 721.1105 to subpart E to read as follows:
Sec. 721.1105 Benzenamine, 4,4'-methylenebis[2-methyl-6-(1-
methylethyl)]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenamine, 4,4'-
methylenebis[2-methyl-6-(1-methylethyl)]- (PMN P-96-93; CAS No. 16298-
38-7) 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) 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.
22. By adding new Sec. 721.1155 to subpart E to read as follows:
Sec. 721.1155 1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl)-and
Bis(dimethylamino substituted)carbomonocycle.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 1,4-
benzenediol, 2-(1,1,3,3-tetramethylbutyl)- and Bis
[[Page 3423]]
(dimethylamino substituted)carbomonocycle (PMN P-96-92) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 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.
23. By adding new Sec. 721.1705 to subpart E to read as follows:
Sec. 721.1705 Benzoic acid, 3-amino-, diazotized, coupled with 6-
amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3-
aminophenyl)phosphonic acid and diazotized 2,5-diethoxybenzenamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as benzoic
acid, 3-amino-, diazotized, coupled with 6-amino-4-hydroxy-2-
naphthalenesulfonic acid, diazotized, (3-amino-phenyl)phosphonic acid
and diazotized 2,5-diethoxybenzenamine (PMN P-96-1216; CAS No. 163879-
69-4) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (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.
24. By adding new Sec. 721.1805 to subpart E to read as follows:
Sec. 721.1805 Substituted bisaniline.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted bisaniline (PMN P-96-1410) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 4).
(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.
25. By adding new Sec. 721.1930 to subpart E to read as follows:
Sec. 721.1930 Butanoic acid, antimony (3+) salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as butanoic acid,
antimony (3+) salt (PMN P-94-1143; CAS No. 53856-17-0) 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)(1), (a)(2)(i), (a)(3), (b) (concentration set at 0.1
percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(g)(1)(i), (g)(1)(vi), (g)(1)(vii), (g)(1)(ix), (g)(2)(i), (g)(2)(v),
and (g)(5). The label and MSDS as required by this paragraph shall also
include the following statement: This substance may cause neurologic
effects. This substance may cause cardiovascular effects. This
substance may cause ocular irritation.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (675,000 kg).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (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.
26. By adding new Sec. 721.2082 to subpart E to read as follows:
Sec. 721.2082 Derivative of substituted carbomonocyclic carboxylic
acid-amine distillation stream byproduct reaction product.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
derivative of substituted carbomonocyclic carboxylic acid-amine
distillation stream byproduct reaction product (PMN P-96-866) 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.
27. By adding new Sec. 721.2091 to subpart E to read as follows:
Sec. 721.2091 Chloroalkane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
chloroalkane (PMN P-96-273) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 3424]]
28. By adding new Sec. 721.2094 to subpart E to read as follows:
Sec. 721.2094 N,N'-di(alkyl heteromonocycle)amino chlorotriazine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as N,N'-
di(alkyl heteromonocycle)amino chlorotriazine (PMN P-93-1369) 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) (this respirator meets the minimum
requirement for persons exposed via inhalation during manufacture),
(a)(5)(ii), (a)(5)(iv), (a)(5)(v) (these three respirators meet the
minimum requirements for persons exposed via inhalation during
processing and use), (a)(6)(i), (a)(6)(ii), (a)(6)(iii), (a)(6)(iv),
(b) (concentration set at 0.1 percent), and (c).
(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)(iv), (g)(1)(vii), (g)(1)(viii), (g)(1)(ix), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv), (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(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), (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.
29. By adding new Sec. 721.2122 to subpart E to read as follows:
Sec. 721.2122 Substituted phenyl azo substituted sulfo
carbopolycycle.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted phenyl azo substituted sulfo carbopolycycle (PMN P-96-702)
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(r) (204,000 kg) (activated sludge
adsorption isotherm- OPPTS 835.1110 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1), daphnid acute toxicity-
Sec. 797.1300, fish acute toxicity-Sec. 797.1400, murine immune
allergic response study (Toxicology and Applied Pharmacology 112:190-
197 (1992)). A person may not manufacture or import the substance
beyond the following aggregate production volume limits, unless that
person conducts the following corresponding studies on the substance
and submits all final reports and underlying data in accordance with
the procedures and criteria specified in paragraphs (a)(2)(i)(A),
(a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(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)(i) 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)(i) 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)(i) 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)(i)(D)(2) of this
section, if, within 6 weeks of EPA's receipt of a test report and data,
the person receives written notice that EPA finds that the data
generated by a study are scientifically invalid, the person is
prohibited from further manufacture and import of the PMN substance
beyond the applicable production volume limit.
(2) The person may continue to manufacture and import the PMN
substance beyond the applicable production limit only if so notified,
in writing, by EPA in response to the person's compliance with either
of the following paragraph (a)(2)(i)(D)(2)(i) or (a)(2)(i)(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)(i)(C)(3) of this section, the person shall comply with paragraph
(a)(2)(i)(C)(3) of this section. If there is insufficient time for the
person to comply with paragraph (a)(2)(i)(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)(i)(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)(i)(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)(i) of this section if notified in writing by EPA that
it is unnecessary to conduct that study.
(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.
30. By adding new Sec. 721.2145 to subpart E to read as follows:
[[Page 3425]]
Sec. 721.2145 Ceteareth-25 sorbate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ceteareth-25 sorbate (PMN P-96-941) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provision 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.
31. By adding new Sec. 721.2222 to subpart E to read as follows:
Sec. 721.2222 Cyclohexanamine, N,N-dimethyl-, compd. with alpha-
isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclohexanamine,
N,N-dimethyl-, compd. with alpha-isotridecyl-omega-hydroxypoly(oxy-1,2-
ethanediyl) phosphate (PMN P-96-1176; CAS No. 164383-18-0) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial and consumer activities. Requirements as
specified in Sec. 721.80(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.
32. By adding new Sec. 721.2280 to subpart E to read as follows:
Sec. 721.2280 Cyclopropanecarboxaldehyde.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as
cyclopropanecarboxaldehyde (PMN P-96-33) 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)(iii), (a)(5)(xii),
(a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b) (concentration set at 1.0
percent), and (c). Each person who is reasonsonably likely to be
exposed by inhalation to the PMN substance in vapor form during loading
of rail cars is provided with, and is required to wear, at a minimum, a
National Institute for Occupational Safety and Health (NIOSH) approved
category 19C Type C supplied-air respirator operated in pressure demand
or other positive pressure mode and equipped with a full facepiece with
an assigned protection factor (APF) of 200. As an alternative to the
respiratory requirements in this section, manufacturers, importers, and
processors may use the new chemical exposure limits provisions,
including sampling and analytical methods which have previously been
approved by EPA for this substance, found in the TSCA section 5(e)
consent order for this substance.
(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)(ii), (g)(1)(iv), (g)(1)(ix), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv), and (g)(5).
(iii) Industrial, commercial, and consumer activites. 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.
33. By adding new Sec. 721.2345 to subpart E to read as follows:
Sec. 721.2345 Alkyletherpropyl dialkylamines.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as alkyletherpropyl
dialkylamines (PMNs P-96-1510/1511/1512/1513/1514) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
34. By adding new Sec. 721.2350 to subpart E to read as follows:
Sec. 721.2350 Alkyltri, tetra, and pentaamines.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkyltri, tetra, and pentaamines (PMNs P-96-406/407/408) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
35. By adding new Sec. 721.2535 to subpart E to read as follows:
Sec. 721.2535 Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer,
Bu alc.-blocked.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 1,1'-
methylanebis[4-isocyanato-, homopolymer, Bu alc.-blocked (PMN P-95-
1386; CAS No. 186321-98-2) 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:
[[Page 3426]]
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
36. By adding new Sec. 721.2805 to subpart E to read as follows:
Sec. 721.2805 Acrylate ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
acrylate ester (PMN P-96-824) 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.
37. By adding new Sec. 721.2925 to subpart E to read as follows:
Sec. 721.2925 Brominated aromatic ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
brominated aromatic ester (PMN P-95-1128) 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)(3)(1), (g)(3)(ii),
(g)(4)(iii), and (g)(5).
(ii) [Reserved]
(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), (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.
38. By adding new Sec. 721.3085 to subpart E to read as follows:
Sec. 721.3085 Brominated phthalate ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
brominated phthalate ester (PMN P-90-581) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(ii) Hazard communication program. A significant new use of this
substance 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 this substance, the employer becomes aware that
this substance may present a risk of injury to human health or the
environment the employer must incorporate this new information, and any
information on methods for protecting against such risk, into a 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 substance from the employer within 5 years from the
date the employer becomes aware of the new information described in
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as
described in Sec. 721.72(c) containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), 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.
39. By adding new Sec. 721.3155 to subpart E to read as follows:
Sec. 721.3155 3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3,8-dioxa-4,7-
disiladecane, 4,4,7,7-tetraethoxy- (PMN P-95-1326; CAS No. 16068-37-4)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
40. By adding new Sec. 721.3465 to subpart E to read as follows:
Sec. 721.3465 Stilbene diglycidyl ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as stilbene diglycidyl
ether (PMN P-96-1427) 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)(ii),
[[Page 3427]]
(a)(5)(iv), (a)(5)(v), (a)(6)(i), (b) (concentration set at 0.1
percent), and (c). As an alternative to the respiratory protection
requirements of this section, manufacturers, importers, and processors
of this substance may follow the terms of the new chemical exposure
limits section in the TSCA section 5(e) consent order for this
substance.
(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)(ii), (g)(1)(vi), (g)(1)(vii), (g)(2)(i), (g)(2)(ii),
(g)(2)(iv), (g)(2)(v), and (g)(5). The label and MSDS as required by
this paragraph shall also include the following statement: When using
this substance use respiratory protection or maintain workplace
airborne concentrations at or below an 8-hour time-weighted average of
0.5 milligram (mg)/meter (m3).
(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.
41. By adding new Sec. 721.3485 to subpart E to read as follows:
Sec. 721.3485 Hydrofluorocarbon alkyl ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydrofluorocarbon alkyl ether (PMN P-95-1578) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. Non-spray uses are exempt from the provisions
of this rule.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(iii), and (a)(6)(v).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
42. By adding new Sec. 721.3488 to subpart E to read as follows:
Sec. 721.3488 Poly(oxy-1,2-ethanediyl), alpha substituted-omega-
hydroxy-, C16-20 alkyl ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
poly(oxy-1,2-ethanediyl), alpha substituted-omega-hydroxy-,
C16-20 alkyl ethers (PMN P-87-323) 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. 721.90 (a)(4), (b)(4), and (c)(4) (N = 20).
(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.
43. By adding new Sec. 721.3565 to subpart E to read as follows:
Sec. 721.3565 Ethylenediamine, substituted, sodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
ethylenediamine, substituted, sodium salt (PMN P-97-328) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
44. By adding new Sec. 721.4085 to subpart E to read as follows:
Sec. 721.4085 Guanidine, pentaethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as guanidine,
pentaethyl- (PMN P-94-1018; CAS No. 13439-89-9) 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), (a)(2)(i), and (a)(3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
45. By adding new Sec. 721.4090 to subpart E to read as follows:
Sec. 721.4090 Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-,
bromide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanaminium, N-
[bis(diethylamino)-methylene]-N-ethyl-, bromide (PMN P-94-1019; CAS No.
89610-32-2) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(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.
46. By adding new Sec. 721.4095 to subpart E to read as follows:
[[Page 3428]]
Sec. 721.4095 Quaternary ammonium alkyltherpropyl trialkylamine
halides.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
quaternary ammonium alkyltherpropyl trialkylamine halides (PMNs P-96-
1280/81/1504/1505/1506/1507/1508) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
47. By adding new Sec. 721.4158 to subpart E to read as follows:
Sec. 721.4158 Hexadecanoic acid, ethenyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hexadecanoic acid,
ethenyl ester (PMN P-97-302; CAS No. 693-38-9) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
48. By adding new Sec. 721.4257 to subpart E to read as follows:
Sec. 721.4257 Hydrazine, (2-fluorophenyl).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hydrazine, (2-
fluorophenyl) (PMN P-95-2101; CAS No. 2368-80-1) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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) 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.
49. By adding new Sec. 721.4259 to subpart E to read as follows:
Sec. 721.4259 Aliphatic polyisocyanate homopolymer.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aliphatic polyisocyanate homopolymer (PMN P-96-1239) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
50. By adding new Sec. 721.4462 to subpart E to read as follows:
Sec. 721.4462 Hydrochlorofluorocarbon.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydrochlorofluorocarbon (PMN P-95-1317) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
51. By adding new Sec. 721.4464 to subpart E to read as follows:
Sec. 721.4464 Mixture of hydrofluoro alkanes and hydrofluoro alkene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as a
mixture of hydrofluoro alkanes and hydrofluoro alkene (PMNs P-96-945/
946/947/948) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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 specified as 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.
52. By adding new Sec. 721.4465 to subpart E to read as follows:
Sec. 721.4465 Hydrofluoroalkane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydrofluoroalkane (PMN P-96-1288) 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(h).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 3429]]
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.
53. By adding new Sec. 721.4467 to subpart E to read as follows:
Sec. 721.4467 Quaternary ammonium hydroxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
quaternary ammonium hydroxide (PMN P-95-1806) 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.
54. By adding new Sec. 721.4468 to subpart E to read as follows:
Sec. 721.4468 1H-Imidazole, 2-ethyl-4,5-dihydro-4-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-imidazole, 2-
ethyl-4,5-dihydro-4-methyl- (PMN P-97-217; CAS No. 931-35-1) 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)(4), (b)(4), and (c)(4) (N = 40).
(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.
55. By adding new Sec. 721.4469 to subpart E to read as follows:
Sec. 721.4469 Imidazolethione.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
imidazolethione (PMNs P-91-1131 and P-90-564) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. Formulations or mixtures containing the PMN
substance in concentrations at or below 10 percent by weight or volume
are exempt from the provisions of this rule.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (b) (concentration set at 0.1 percent), and
(c).
(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)(ix), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS
as required by this paragraph shall also include the following
statements: This substance may cause thyroid cancer. This substance may
cause thyroid effects.
(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), and (h) 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.
56. By adding new Sec. 721.4476 to subpart E to read as follows:
Sec. 721.4476 Substituted imines.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted imines (PMNs P-95-1557/1558) are subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
57. By adding new Sec. 721.4589 to subpart E to read as follows:
Sec. 721.4589 Propanedioic acid, [(4-methoxyphenyl)methylene]-,
bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propanedioic acid,
[(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-piperidinyl)
ester (9CI) (PMN P-95-1411; CAS No. 147783-69-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(i), (a)(5)(ii), (a)(5)(iii), (a)(6)(i), (b)
(concentration set at 1.0 percent), and (c). As an alternative to the
respiratory protection requirements of this section, manufacturers,
importers, and processors of this substance may follow the terms of the
new chemical exposure limits section in the TSCA section 5(e) consent
order for this substance.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(iv), (g)(1)(vi),
(g)(1)(viii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), 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), (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.
58. By adding new Sec. 721.4885 to subpart E to read as follows:
[[Page 3430]]
Sec. 721.4885 Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5-
(1,1,3,3-tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy)
phenyl]phenyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as methanone, [5-[[3-
(2H-benzotriazol-2-yl)-2-hydroxy-5-(1,1,3,3-
tetramethylbutyl)phenyl]methyl]-2-hydroxy-4-(octyloxy)phenyl]phenyl-
(PMN P-96-942; CAS No.162245-07-0) is subject to the 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)(ii), (a)(5)(iii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (b) (concentration set at 1.0 percent), and (c). As an
alternative to the respiratory protection requirements of this section,
manufacturers, importers, and processors of this substance may follow
the terms of the new chemical exposure limits section in the TSCA
section 5(e) consent order for this substance.
(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)(iv), (g)(1)(vi), (g)(1)(viii), (g)(2)(ii),
(g)(2)(iv), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (f), (g), (h), and (i) are applicable
to manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
59. By adding new Sec. 721.5255 to subpart E to read as follows:
Sec. 721.5255 2-Naphthalenol, mono and dioctyl derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-naphthalenol,
mono and dioctyl derivs (PMN P-95-1288) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N = 1). When calculating the surface
water concentrations according to the instructions in Sec. 721.91, the
statement that the amount of the substance that will be released will
be calculated before the substance enters control technology does not
apply. Instead, if the waste stream containing the substance will be
treated before release, then the amount of the substance reasonably
likely to be removed from the waste stream by such treatment may be
subtracted in calculating the number of kilograms released. No more
than 90 percent removal efficiency may be attributed to such treatment.
(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.
60. By adding new Sec. 721.5279 to subpart E to read as follows:
Sec. 721.5279 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-
4-[(3-butoxy-2-hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-
biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,7-
naphthalenedisulfonic acid, 4-amino-3-[[4'2-amino-4-[(3-butoxy-2-
hydroxypropyl)amino]phebyl]azo]-3,3'-dimethyl[1,1'-biphenyl]-4-yl]azo]-
5-hydroxy-6-(phenylazo)-, disodium salt (PMN P-97-131; CAS No. 103580-
64-9) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 40).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
61. By adding new Sec. 721.5280 to subpart E to read as follows:
Sec. 721.5280 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-,
coupled with diazotized 4-butylbenzenamine, diazotized 4,4'-
cyclohexylidenebis[benzenamine] and m-phenylenediamine, sodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,7-
naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with diazotized
4-butylbenzenamine, diazotized 4,4'-cyclohexyl-idenebis[benzenamine]
and m-phenylenediamine, sodium salt (PMN P-97-193; CAS No. 182238-09-1)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (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.
62. By adding new Sec. 721.5281 to subpart E to read as follows:
Sec. 721.5281 2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-
sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7-
(phenylamino)-, sodium salt, compd. With 2,2',2''-nitrilotris [ethanol]
(9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-
Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6-sulfophenyl)azo]-2-
methoxy-5-methylphenyl]azo]-4-hydroxy-7-(phenylamino)-, sodium salt,
compd. With 2,2',2''-nitrilotris [ethanol] (9CI) (PMN P-95-1235; CAS
No. 94213-53-3) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(1), (w)(1), and (x)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 3431]]
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements 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.
63. By adding new Sec. 721.5547 to subpart E to read as follows:
Sec. 721.5547 Antimony double oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
antimony double oxide (PMNs P-95-677 and P-95-724) 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) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(3)(ii), and (g)(5). The
label and MSDS as required by this paragraph shall also include the
following statements: These substances may cause lung toxicity. When
using these substances avoid any applications of these substances which
could cause inhalation exposures. When using these substances keep in
liquid form only.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(1), (v)(2), (w)(1), (w)(2),
(x)(1), (x)(2), (y)(1), and (y)(2). Manufacturing, processing or use in
any form which could cause inhalation exposures.
(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 specified in
Sec. 721.125 (a), (b), (c), (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.
64. By adding new Sec. 721.5549 to subpart E to read as follows:
Sec. 721.5549 Lithiated metal oxide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
lithiated metal oxide (LiNiO2) (PMN P-96-19; CAS No. 12031-
65-1) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(iv),
(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.
(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)(iv), (g)(1)(vii), (g)(1)(viii), (g)(2)(i), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)4)(i),
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), (b)(4), and (c)(4) (N = 30).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125(a), (b), (c), (d), (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.
65. By adding new Sec. 721.5645 to subpart E to read as follows:
Sec. 721.5645 Pentane 1,1,1,2,3,4,4,5,5,5,-decafluoro.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pentane
1,1,1,2,3,4,4,5,5,5,-decafluoro (PMN P-95-638 and SNUN P-97-79; CAS No.
138495-42-8) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and uses other than as described in the
significant new use notice.
(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.
66. By adding new Sec. 721.5650 to subpart E to read as follows:
Sec. 721.5650 Pentanediol light residues.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
pentanediol light residues (PMN P-95-1750) 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(o).
(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.
67. By adding new Sec. 721.5708 to subpart E to read as follows:
Sec. 721.5708 2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-Pentene,
1,1,1,2,3,4,4,5,5,5-decafluoro- (PMN P-95-637; CAS No.72804-49-0) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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 specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 3432]]
68. By adding new Sec. 721.5725 to subpart E to read as follows:
Sec. 721.5725 Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 2,4-
dimethyl-6-(1-methylpentadecyl)-) (PMN P-94-209; CAS No. 134701-20-5)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i) and (a)(3).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (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.
69. By adding new Sec. 721.5730 to subpart E to read as follows:
Sec. 721.5730 Phenol, 4,4''-methylenebis[2,6-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 4,4''-
methylenebis[2,6-dimethyl- (PMN P-94-921) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v),
(a)(6)(i), (b) (concentration set at 1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1 percent),
(f), (g)(1)(iv), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and
(g)(5). The label and MSDS as required by this paragraph shall also
include the following statements: This substance may cause blood
effects. This substance may cause chronic effects.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (l), 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. 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.
70. By adding new Sec. 721.5913 to subpart E to read as follows:
Sec. 721.5913 Phenothiazine derivative.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phenothiazine derivative (PMN P-96-813) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a) and (i) are applicable to manufacturers, and importers
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
71. By adding new Sec. 721.5995 to subpart E to read as follows:
Sec. 721.5995 Polyalkyl phosphate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polyalkyl phosphate (PMN P-95-1772) 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) Releases to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 1 ppb).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
72. By adding new Sec. 721.6045 to subpart E to read as follows:
Sec. 721.6045 Phosphinothioic acid, bis(2,4,4-trimethylpentyl)-
(9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphinothioic
acid, bis(2,4,4-trimethylpentyl)- (9CI) (PMN P-96-1652; CAS No. 132767-
86-3) 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)(4), (b)(4), and (c)(4) (N = 10). When calculating the surface water
concentrations according to the instructions in Sec. 721.91, the
statement that the amount of the substance that will be released will
be calculated before the substance enters control technology does not
apply. Instead, if the waste stream containing the substance will be
treated using carbon adsorption treatment before release, then the
amount of the substance reasonably likely to be removed from the waste
stream by such treatment may be subtracted in calculating the number of
kilograms released. No more than 99 percent removal efficiency may be
attributed to such treatment.
(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.
73. By adding new Sec. 721.6075 to subpart E to read as follows:
Sec. 721.6075 Phosphonic acid, 1,1-methylenebis-tetrakis(1-
methylethyl) ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonic acid,
1,1-methylenebis-tetrakis(1-methylethyl) ester (PMN P-95-168) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
[[Page 3433]]
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(2)(iv), (a)(3), (b)
(concentration set at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(2)(i), (g)(2)(v), and (g)(5). The label and MSDS required by
this paragraph shall also include the following statement: This
substance may cause mutagenicity.
(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) through (h) 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.
74. By adding new Sec. 721.6078 to subpart E to read as follows:
Sec. 721.6078 Substituted ethoxyethylamine phosphonate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted ethoxyethylamine phosphonate (PMN P-95-1950) 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.
75. By adding new Sec. 721.6165 to subpart E to read as follows:
Sec. 721.6165 Polysubstituted piperidine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polysubstituted piperdine (PMN P-93-568) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 30).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
76. By adding new Sec. 721.6170 to subpart E to read as follows:
Sec. 721.6170 Siloxanes and silicones, Me hydrogen, reaction products
with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, Me hydrogen, reaction products with 2,2,6,6-tetramethyl-4-
(2-propenyloxy)piperdine (PMN P-95-1891; CAS No. 182635-99-0) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (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.
77. By adding new Sec. 721.6197 to subpart E to read as follows:
Sec. 721.6197 Salt of a substituted polyalkylenepolyamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a salt
of a substituted polyalkylenepolyamine (PMN P-96-585) 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.
78. By adding new Sec. 721.6475 to subpart E to read as follows:
Sec. 721.6475 Alkyl polycarboxylic acids, esters with ethoxylated
fatty alcohols.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
polycarboxylic acids, esters with ethoxylated fatty alcohols (PMNs P-
96-554/555/556/557/558/559) are subject to reporting under this section
for the significant new uses described in paragraph (a)(1)(i) 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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Chemical substance and significant new uses subject to
reporting. The chemical substances identified generically as alkyl
polycarboxylic acids, esters with ethoxylated fatty alcohols (PMN P-96-
560/561/564/565) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(i) The significant new uses are:
(A) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(B) [Reserved]
(ii) Specific requirements. The provisions of subpart A of this
part apply to this section except as modified by this paragraph.
[[Page 3434]]
(A) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(B) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
79. By adding new Sec. 721.6477 to subpart E to read as follows:
Sec. 721.6477 Alkyl polycarboxylic acids, esters with ethoxylated
fatty alcohols, reaction products with maleic anhydride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
polycarboxylic acids, esters with ethoxylated fatty alcohols, reaction
products with maleic anhydride (PMNs P-96-399/400/401/402/403/404) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
80. By adding new Sec. 721.6485 to subpart E to read as follows:
Sec. 721.6485 Hydroxy terminated polyester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydroxy terminated polyester (PMN P-95-1213) 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 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.
81. By adding new Sec. 721.6490 to subpart E to read as follows:
Sec. 721.6490 Alkyl phenyl polyetheramines.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
phenyl polyetheramines (PMNs P-95-1650/1651/1652/1653) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
82. By adding new Sec. 721.6495 to subpart E to read as follows:
Sec. 721.6495 Aliphatic polyisocyanate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aliphatic polyisocyanate (PMN P-95-1347) 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(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
83. By adding new Sec. 721.6505 to subpart E to read as follows:
Sec. 721.6505 Polymers of C13C15 oxoalcohol
ethoxolates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polymers of C13C15 oxoalcohol ethoxolates (PMNs
P-96-950/951) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
84. By adding new Sec. 721.7375 to subpart E to read as follows:
Sec. 721.7375 Potassium salt of polyolefin acid.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
potassium salt of polyolefin acid (PMN P-97-417) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
85. By adding new Sec. 721.7378 to subpart E to read as follows:
Sec. 721.7378 Substituted polyoxyethylene.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted polyoxyethylene (PMN P-93-1654) is
[[Page 3435]]
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) (use as an emulsifier for paint and
adhesives).
(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.
86. By adding new Sec. 721.8079 to subpart E to read as follows:
Sec. 721.8079 Isophorone diisocyanate neopentyl glycol adipate
polyurethane prepolymer.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isophorone diisocyanate neopentyl glycol adipate polyurethane
prepolymer (PMN P-94-1743) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section. Non-spray uses are exempt from the provisions of this rule.
(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)(iii), (a)(5)(viii),
(a)(5)(ix), (a)(5)(x), (a)(5)(xi), (a)(6)(i), (a)(6)(ii), (a)(6)(iv),
and (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), (g)(1)(i), (g)(1)(ii), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),
(g)(2)(iv), (g)(2)(v), and (g)(5). Manufacturers, importers, and
processors who implement the product stewardship provisions of the TSCA
section 5(e) consent order for these substances are exempt from the
requirements of Sec. 721.63 and Sec. 721.72.
(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) through (i) are applicable to manufacturers,
importers, and processors of this substance. Manufacturers, importers,
and processors who implement the product stewardship provisions and
keep records as required by the TSCA section 5(e) consent order for
these substances are exempt from the requirements of Sec. 721.125.
(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) Applicability of Sec. 721.5. The provisions of Sec. 721.5 do
not apply to manufacturers, importers, and processors, implementing the
product stewardship provisions in the TSCA section 5(e) consent order
for this substance.
87. By adding new Sec. 721.8095 to subpart E to read as follows:
Sec. 721.8095 Silylated polyurethane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
silylated polyurethane (PMN P-95-1356) 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(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
88. By adding new Sec. 721.8780 to subpart E to read as follows:
Sec. 721.8780 Substituted pyridine azo substituted phenyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted pyridine azo substituted phenyl (PMNs P-96-767 and P-96-
773) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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) and (i) are applicable to manufacturers and importers
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
89. By adding new Sec. 721.9005 to subpart E to read as follows:
Sec. 721.9005 2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pyrrolidinone,
1,1'-(2-methyl-1,5-pentanediyl)bis- (PMN P-93-761; CAS No. 146453-62-5)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i) (There must be no permeation of the PMN
substance greater than 0.08 grams (g)/minutes (min) centimeter
(cm2) after 8 hours of testing in accordance with the most
current version of the American Society for Testing and Materials
(ASTM) F739 ``Standard Test Method for Resistance of Protective
Clothing Materials to Permeation by Liquids or Gases.'' The results of
all glove permeation testing must be reported in accordance with the
most current version of (ASTM) F1194 ``Guide for Documenting the
Results of Chemical Permeation Testing of Protective Clothing
Materials.'' Manufacturers, importers, and processors must submit such
glove test data to the Agency and must receive written Agency approval
for each type of glove tested prior to use of such gloves. The
following gloves have been tested in accordance with the ASTM F739
method and found to satisfy the requirements for use by EPA: Ansell
Edmond/8-352/Neoprene rubber, 0.097 cm thick. Gloves may not be used
for a time period longer than they are actually tested and must be
replaced at the end of each work shift), (a)(2)(ii), (a)(2)(iii),
(a)(3), (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
[[Page 3436]]
1.0 percent), (f), (g)(l)(iii), (g)(l)(iv), (g)(2)(i), (g)(2)(iii),
(g)(2)(v), and (g)(5). The label and MSDS as required by this paragraph
shall also include the following statement: This substance is expected
to enhance the absorption of other chemicals into skin or other
materials.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (o), (q), and (k) (use other than as a heat
transfer fluid).
(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.
90. By adding new Sec. 721.9010 to subpart E to read as follows:
Sec. 721.9010 2-pyrrolidone, 1-ethenyl-3-ethylidene-, (E)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-pyrrolidone, 1-
ethenyl-3-ethylidene-, (E)- (PMN P-96-1536; CAS No. 153954-47-3) 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) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i) and (a)(3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
91. By adding new Sec. 721.9080 to subpart E to read as follows:
Sec. 721.9080 Nitro methyl quinoline.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as nitro
methyl quinoline (PMN P-96-1319) 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)(ii), (a)(5)(iv), (a)(5)(v), and (a)(6)(i).
(ii) Disposal. Requirements as specified in Sec. 721.85 (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), and (j) 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.
92. By adding new Sec. 721.9265 to subpart E to read as follows:
Sec. 721.9265 Reaction product of dichlorobenzidine and substituted
alkylamide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
reaction product of dichlorobenzidine and substituted alkylamide (PMN
P-95-1282) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e), (f), and (g)(5). The label and
MSDS as required by this paragraph shall also include the following
statements: At temperatures above 200 deg.C, this substance decomposes
to produce a suspect human carcinogen, 3',3' dichlorobenzidine. Do not
heat above 200 deg.C or 392 deg.F.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and processing or use of the PMN
substance at temperatures above 200 deg.C.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (f), (g), (h), 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.
93. By adding new Sec. 721.9270 to subpart E to read as follows:
Sec. 721.9270 Reaction product of epoxy with anhydride and glycerol
and glycol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of epoxy with anhydride and glycerol and glycol (PMN
P-96-1233) 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), (x)(1) and (y)(2).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
94. By adding new Sec. 721.9285 to subpart E to read as follows:
Sec. 721.9285 Reaction products of formalin (37%) with amine
C12.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction products of formalin (37%) with amine C12 (PMN P-
95-535) 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.
95. By adding new Sec. 721.9488 to subpart E to read as follows:
[[Page 3437]]
Sec. 721.9488 Substituted resorcinols.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted resorcinols (PMNs P-95-1103, P-95-1104, and P-96-1235) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 9).
(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 recordkeeping requirements 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.
96. By adding new Sec. 721.9492 to subpart E to read as follows:
Sec. 721.9492 Polymers of styrene, cyclohexyl methacrylate and
substituted methacrylate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
polymers of styrene, cyclohexyl methacrylate and substituted
methacrylate (PMNs P-97-143/144) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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) 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.
97. By adding new Sec. 721.9497 to subpart E to read as follows:
Sec. 721.9497 Trifunctional ketoximino silane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
trifunctional ketoximino silane (PMNs P-95-605 and P-95-606) 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)(2)(i), and (a)(3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), and (e) are applicable to
manufacturers, importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
98. By adding new Sec. 721.9499 to subpart E to read as follows:
Sec. 721.9499 Modified silicone resin.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
modified silicone resin (PMN P-96-1649) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 5).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
99. By adding new Sec. 721.9503 to subpart E to read as follows:
Sec. 721.9503 Silane, (3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-
heptadecafluorodecyl)trimethoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as silane,
(3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluorodecyl) trimethoxy-
(PMN P-97-264; CAS No. 83048-65-1) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xv),
(a)(6)(ii), and (a)(6)(v).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), 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.
100. By adding new Sec. 721.9515 to subpart E to read as follows:
Sec. 721.9515 Aminofunctional alkoxy alkyl siloxane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
aminofunctional alkoxy alkyl siloxane (PMN P-96-346) 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.
101. By adding new Sec. 721.9545 to subpart E to read as follows:
Sec. 721.9545 Substituted phenyl azo substituted sulfocarbopolycle,
sodium salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted phenyl azo substituted sulfocarbopolycle, sodium salt (PMN
P-96-1263) 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
[[Page 3438]]
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.
102. By adding new Sec. 721.9575 to subpart E to read as follows:
Sec. 721.9575 Chromate(3-), bis[3-[[5-(aminosulfonyl)-2-
hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl]
propyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as chromate(3-),
bis[3-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-
[(phenylamino)carbonyl] propyl]azo]-2-naphthalene sulfonato(3-)]-,
trisodium (9CI) (PMN P-95-1575; CAS No. 119535-63-6) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (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.
103. By adding new Sec. 721.9576 to subpart E to read as follows:
Sec. 721.9576 Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
(aminosulfonyl)-2-hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato
(3-)]-, trisodium (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as chromate(3-),
bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-
hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium
(9CI) (PMN P-95-1576; CAS No. 118716-62-4) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (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.
104. By adding new Sec. 721.9577 to subpart E to read as follows:
Sec. 721.9577 Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-
(aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalene sulfonato
(3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2-
hydroxy-1-[(phenylamino) carbonyl]-1-propenyl]azo]-2-
naphthalenesulfonato(3-)]-, trisodium (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as chromate(3-),
bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2-hydroxy phenyl]
azo]-4-hydroxy-2-naphthalenesulfonato (3-)]-,-[[5-(aminosulfonyl) -2-
hydroxyphenyl]azo]-4-hydroxy-7-[[2-hydroxy-1-[(phenylamino) carbonyl]-
1-propenyl]azo]-2-naphthalene sulfonato(3-)]-, trisodium (9CI) (PMN P-
95-1577; CAS No. 118716-61-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (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.
105. By adding new Sec. 721.9635 to subpart E to read as follows:
Sec. 721.9635 Terpene residue distillates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as terpene
residue distillates (PMN P-96-897) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 10).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. 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.
106. By adding new Sec. 721.9657 to subpart E to read as follows:
Sec. 721.9657 Disubstituted thiadiazole.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
disubstituted thiadiazole (PMN P-97-314) 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 (a),(b), (c), and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
107. By adding new Sec. 721.9659 to subpart E to read as follows:
Sec. 721.9659 Disubstituted thiadiazosulfone.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
disubstituted thiadiazosulfone (PMN P-97-304) is
[[Page 3439]]
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 (a),(b), (c), and (j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
108. By adding new Sec. 721.9662 to subpart E to read as follows:
Sec. 721.9662 Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as thieno[3,4-b]-1,4-
dioxin, 2,3-dihydro- (9CI) (PMN P-95-1825; CAS No. 126213-50-1) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(4), (a)(5)(xii), (a)(5)(xiii),
(a)(5)(xiv), and (a)(6)(v).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), and (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.
109. By adding new Sec. 721.9664 to subpart E to read as follows:
Sec. 721.9664 9H-Thioxanthen-9-one,2,4-diethyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 9H-thioxanthen-9-
one,2,4-diethyl (PMN P-96-1315; CAS No. 82799-44-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 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.
110. By adding new Sec. 721.9717 to subpart E to read as follows:
Sec. 721.9717 Azo monochloro triazine reactive dye.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an azo
monochloro triazine reactive dye (PMN P-96-238) 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)(2), (w)(2), and (x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
111. By adding new Sec. 721.9825 to subpart E to read as follows:
Sec. 721.9825 Phenyl substituted triazolinones.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as phenyl
substituted triazolinones (PMNs P-93-204, P-94-1870, P-94-1871, P-94-
1872, P-94-1873, and P-94-1874) 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)(2)(i), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv),
(a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at 1.0
percent), and (c). The imperviousness of the gloves selected pursuant
to (a)(2)(i) of this section must be demonstrated by actual testing
under (a)(3)(i) of this section and not by manufacturer specifications.
In addition, there must be no permeation of the chemical substance
greater than 15 g/day-cm2 as a daily cumulative
total when tested in accordance with the most current version of the
American Society for Testing and Materials (ASTM) F739 ``Standard Test
Method for Resistance of Protective Clothing Materials to Permeation by
Liquids or Gases'' or ASTM F1383 ``Standard Test Method for Resistance
of Protective Clothing Materials to Permeation by Liquids or Gases
Under Conditions of Intermittent Contact.''
(A) For conditions of exposure which are intermittent, gloves may
be tested in accordance with the most current version of ASTM F1383
``Standard Test Method for Resistance of Protective Clothing Materials
to Permeation by Liquids or Gases Under Conditions of Intermittent
Contact,'' provided the contact time in testing is greater than or
equal to the expected duration of dermal contact, and the purge time
used in the testing is less than or equal to the expected duration of
non-contact during the intermittent cycle of dermal exposure in the
workplace. If ASTM F1383 is used for testing, the company must submit
to the Agency a description of worker activities involving the chemical
substance which includes daily frequencies and durations of potential
worker exposures.
(B) The results of all glove permeation testing must be reported in
accordance with the most current version of (ASTM) F1194 ``Guide for
Documenting the Results of Chemical Permeation Testing of Protective
Clothing Materials.'' The company must submit all test data to the
Agency and must receive written Agency approval for each type of glove
tested prior to use of such gloves. Gloves must be discarded and
replaced with such frequency as to ensure that they will reliably
provide an impervious barrier to the chemical substances under normal
and expected conditions of exposure within the work area. Gloves that
have been damaged or are defective shall not be used. For PMNs P-94-
1871 through P-94-1874, EPA has approved North Safety Butyl Rubber
gloves (32 mils thick). For P-93-204 and P-94-1870, EPA has approved
North Safety Butyl Rubber gloves (32 mils thick) only if used in
combination with a chemical-resistant glove that has been demonstrated
(EPA review not required) impermeable to the solvent,
[[Page 3440]]
e.g., North Silvershield gloves and North 4H gloves.
(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)(iv), (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)(i), and (g)(5).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 5 for all the chemical substances
subject to the provisions of this rule combined). However, contrary to
the requirements specified in Sec. 721.91, if the waste stream
containing the chemical substances will be treated using activated
carbon adsorption, then the amount of chemical substances reasonably
likely to be removed from the waste stream by such treatment may be
subtracted in calculating the number of kilograms released. No more
than the following percent removal efficiencies may be attributed to
such treatment for each PMN: P-93-204, 99 percent; P-94-1870, 98
percent; P-94-1871, 97 percent; P-94-1872, 92 percent; P-94-1873, 90
percent; P-94-1874, 73 percent.
(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 (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.
112. By adding new Sec. 721.9830 to subpart E to read as follows:
Sec. 721.9830 1-Tridecyn-3-ol, 3-methyl.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-tridecyn-3-ol, 3-
methyl (PMN P-96-236; CAS No. 100912-15-0) 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) Worker protection. Requirements as specified in Sec. 721.63
(a)(1), (a)(2)(i), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
113. By adding new Sec. 721.9840 to subpart E to read as follows:
Sec. 721.9840 Tungstate (W12(OH)2O386-) hexasodium (9CI).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as tungstate
(W12(OH)2O386-) hexasodium (9CI) (PMN P-96-1177; CAS No. 12141-67-2) 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) 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), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
114. By adding new Sec. 721.9928 to subpart E to read as follows:
Sec. 721.9928 Urea, tetraethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as urea, tetraethyl-
(PMN P-94-1017; CAS No. 1187-03-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(r) (445,000 kg) (a dermal developmental
toxicity study in mice and rats and either a chromosome aberration
assay in mice (40 CFR 798.5385) or a micronucleus assay in mice (40 CFR
798.5395)). A person may not manufacture or import the substance beyond
the following aggregate production volume limits, unless that person
conducts the following corresponding studies on the substance and
submits all final reports and underlying data in accordance with the
procedures and criteria specified in paragraphs (a)(2)(i)(A),
(a)(2)(i)(B), (a)(2)(i)(C), and (a)(2)(i)(D) of this section.
(A) Each study required to be performed pursuant to this section
must be scientifically valid. Scientific valid means that the study was
conducted according to:
(1) The test guidelines specified in paragraph (a)(2)(i) 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)(i) 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)(i) 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)(ii)(D)(2) of this
section, if, within 6 weeks of EPA's receipt of a test report and data,
the person receives written notice that EPA finds that the data
generated by a study are scientifically invalid, the person is
prohibited from further manufacture and import of the PMN substance
beyond the applicable production volume limit.
(2) The person may continue to manufacture and import the PMN
substance beyond the applicable production limit only if so notified,
in writing, by EPA in response to the person's compliance with either
of the following paragraph (a)(2)(ii)(D)(2)(i) or (a)(2)(ii)(D)(2)(ii)
of this section.
[[Page 3441]]
(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)(ii)(C)(3) of this section, the person shall comply with
paragraph (a)(2)(ii)(C)(3) of this section. If there is insufficient
time for the person to comply with paragraph (a)(2)(ii)(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)(ii)(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)(ii)(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)(i) of this section if notified in writing by EPA that
it is unnecessary to conduct that study.
(iii) 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), (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.
[FR Doc. 98-1074 Filed 1-21-98; 8:45 am]
BILLING CODE 6560-50-F