[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Rules and Regulations]
[Pages 63726-63740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30474]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50623; FRL-4964-3]
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 certain
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 January 31, 1997. This rule
shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.)
on December 16, 1996.
If EPA receives notice before January 2, 1997 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-50623 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.
All comments which are claimed confidential must be clearly marked
as such. Three additional sanitized copies of any comments containing
confidential business information (CBI) must also be submitted.
Nonconfidential versions of comments on this rule will be placed in the
rulemaking record and will be available for public inspection. Comments
and data may also be submitted electronically by sending electronic
mail (e-mail) to: [email protected]. 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 file format or ASCII file format. All comments and data in
electronic form must be identified by the docket number 50623. No CBI
should be submitted through e-mail. Electronic comments on this final
rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit X
of this document.
FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental
Assistance Division (7408), Office of Toxic Substances, Environmental
Protection Agency, Rm. E-543B, 401 M St., SW., Washington, DC 20460,
telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCA-
H[email protected].
SUPPLEMENTARY INFORMATION: 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 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 subpart A of 40 CFR part
721. These provisions describe persons subject to the rule,
recordkeeping requirements, exemptions to reporting requirements, and
applicability of the rule to uses occurring before the effective date
of the final rule. Provisions relating to user fees appear at 40 CFR
part 700. Persons subject to this SNUR must comply with the same notice
requirements and EPA regulatory procedures as submitters of PMNs under
section 5(a)(1)(A) of TSCA. In particular, these requirements include
the information submission requirements of section 5(b) and 5(d)(1),
the exemptions authorized by section 5 (h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUR notice, EPA may take regulatory action under 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 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), basis for
the action taken by EPA in the section 5(e) consent order or as a non-
section 5(e) SNUR for the substance (including the statutory citation
and specific finding), toxicity concern, and the CFR citation assigned
in the regulatory text section of this rule. The specific uses which
are designated as significant new uses are cited in the regulatory text
section of this document by reference to 40 CFR part 721, subpart B
where the significant
[[Page 63727]]
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 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 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 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-94-357, P-94-658, P-95-1777,
P-94-1779, P-94-1799/1800/1801, P-94-2237, P-95-92, P-95-142, and P-95-
143 which are subject to a final TSCA section 5(e) consent order. The
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 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 section 5(e) order is usually completed within 1 to 2
years of notice of commencement. EPA's experience with exposure-based
SNURs requiring short-term testing is that the SNUR is often revoked
within 1 to 2 years when the test results are received. Rather than
issue and revoke SNURs in such a short span of time, EPA will defer
publication of exposure-based SNURs until either a notice of
commencement (NOC) or data demonstrating risk are received unless the
toxicity testing required is long-term. EPA is issuing this explanation
and notification as required in 40 CFR 721.160(a)(2) as it has
determined that SNURs are not needed at this time for these substances
which are subject to a final section 5(e) consent order under TSCA.
PMN Numbers P-91-1210 and P-92-714
Chemical name: (generic) Aliphatic polyisocyanates.
CAS number: Not available.
Effective date of section 5(e) consent order: April 26, 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 substances and similar isocyanates
have shown them to cause skin sensitization and chronic lung toxicity
in test animals.
Recommended testing: EPA has determined that the results of a 90-day
chronic inhalation toxicity study (40 CFR 798.3260) would help to
characterize the possible human health risks caused by the manufacture,
import, processsing, and use of the PMN substances.
CFR citation: 40 CFR 721.4497.
PMN Numbers P-91-1299, P-95-1667, P-95-1298, and P-95-1297
Chemical name: l-Aspartic acid, homopolymer and ammonium and potassium
salts.
CAS number: 25608-40-6 (P-91-1299 and P-95-1667) and 64723-18-8 (P-91-
1298).
Effective date of section 5(e) consent order: March 29, 1993.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II), of
TSCA based on findings that this substance is expected to be produced
in substantial quantities and there may be significant or substantial
human exposure to the substances.
Recommended testing: EPA has determined that a 28-day oral study (OECD
407), an acute oral study (OPPTS 870.1100 test guideline), an ames
assay (40 CFR 798.5265), a mouse micronucleus assay by the
intraperitoneal route (40 CFR 798.5395), and a developmental toxicity
study in one species by the oral route (40 CFR 798.4900), would help
characterize possible environmental effects of the substance. The PMN
submitter of P-91-1297, P-91-1298, and P-91-1299 has agreed not to
exceed the production volume limit without performing these tests on
one of the PMN substances.
CFR citation: 40 CFR 721.979.
PMN Number P-93-1694
Chemical name: 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-
dimethyloxazolidine.
CAS number: 121776-57-6.
Effective date of section 5(e) consent order: November 29, 1994.
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: The PMN substance and similar chemicals have been
shown to cause oncogenicity, maternal and developmental toxicity,
reproductive toxicity, systemic toxicity (liver and thymus), and
environmental toxicity in test organisms.
Recommended testing: No testing recommended. Data on potential
exposures or releases of the substance, testing other than that
specified in the section 5(e) order for the substance, 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.
CFR citation: 40 CFR 721.5545.
PMN Number P-94-351
Chemical name: (generic) Halogenated indane.
CAS number: Not available.
Effective date of section 5(e) consent order: January 30, 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
oncogenicity
[[Page 63728]]
in test organisms. Laboratory animal and human epidemiological studies
of halogenated dibenzodioxins and dibenzofurans have shown mutagenic
and oncogenic effects; these may form as a by-product of manufacture of
the PMN substance or during the incineration of the polymer matrices
that contain the PMN substance.
Recommended testing: (1) Dioxin/Furan contamination study; and (2)
incineration simulation testing (protocol guidelines are available in
the March 29, 1991, Midwest Research Institute report entitled
``Guidelines for the Determination of Polyhalogenated Dibenzo-para-
Dioxins and Dibenzofurans in PMN Substances, Selected Waste Streams,
and Simulated Incinerator Emissions'') would help characterize the
potential for dioxin and furan formation through incineration of
polymer matrices containing the PMN substance. EPA feels a 90-day
subchronic toxicity study (40 CFR 798.2650) would help EPA characterize
the human health effects of the PMN substance. The PMN submitter has
agreed not to exceed the first production volume limit without
performing the dioxin/furan contamination study. The PMN submitter has
also agreed not to exceed the second and third higher production volume
limits without performing incineration simulation testing and the 90-
day subchronic toxicity study.
CFR citation: 40 CFR 721.4484.
PMN Number P-94-437
Chemical name: (generic) Polycyclic isocyanate.
CAS number: Not available.
Effective date of section 5(e) consent order: March 14, 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 and the environment.
Toxicity concern: Similar chemicals have been shown to cause pulmonary
sensitization and lung effects in test animals. The PMN substance
itself has been shown to cause dermal sensitization in test animals. In
addition, based on structure activity relationship (SAR) predictions
for isocyanates, there is concern that the substance may cause toxicity
to aquatic organisms at concentrations above 5 ppb.
Recommended testing: A 90-day subchronic toxicity study conducted via
the inhalation route (rats) as described at 40 CFR 798.2450 and a
pulmonary sensitization study conducted either by the Karol method
(Toxicology and Applied Pharmacology 68:229-241 (1983)) or an
equivalent method are needed to help characterize the lung effects and
pulmonary sensitization, respectively. An acute algal (40 CFR
797.1050), an acute daphnid (40 CFR 797.1300), and an acute fish (40
CFR 797.1400) study are needed to help characterize the aquatic
toxicity effects of the PMN substance. The PMN submitter has agreed not
to exceed a production volume limit without performing the 90-day
subchronic and pulmonary sensitization studies.
CFR citation: 40 CFR 721.4494.
PMN Number P-94-1557
Chemical name: (generic) Hydrated alkaline earth metal salts of
metalloid oxyanions.
CAS number: Not available.
Effective date of section 5(e) consent order: May 12, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) of TSCA
based on a finding that this substance may present an unreasonable risk
of injury to human health, is expected to be produced in substantial
quantities, and may reasonably be expected to enter the environment in
substantial quantities.
Toxicity concern: Similar chemicals have been shown to cause acute
toxicity, reproductive toxicity, developmental toxicity, kidney and
liver effects, and spleen, blood and adrenal toxicity in test animals.
Recommended testing: EPA has determined that a 90-day subchronic
toxicity study (OPPTS 870.3100 test guidelines), developmental toxicity
study (40 CFR 798.4900), an acute algal study (40 CFR 797.1050), and an
activated sludge sorption isotherm study (OPPTS 835.1110 test
guideline) would help characterize the human health and environmental
effects of the substance. The PMN submitter has agreed not to exceed a
specified production volume limit without performing the acute algal
and activated sludge adsorption isotherm studies.
CFR citation: 40 CFR 721.4468.
PMN Numbers P-94-1634/1635/1636/1637/1638/1639
Chemical name: Fatty acids, C(14-18)-unsaturated, branched and linear,
methyl and butyl esters.
CAS number: Not available.
Effective date of section 5(e) consent order: September 28, 1994.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(II), of TSCA based on findings
that this substance is expected to be produced in substantial
quantities, and may reasonably be expected to enter the environment in
substantial quantities.
Recommended testing: EPA has also determined that a one-species
developmental toxicity study (40 CFR 798.4900) by the oral route would
help characterize possible health effects of the substance. The PMN
submitter has agreed not to exceed the production volume limit without
performing this test on P-94-1639.
CFR citation: 40 CFR 721.3628.
PMN Number P-94-1744
Chemical name: (generic) Substituted benzotriazole.
CAS number: Not available.
Effective date of section 5(e) consent order: February 3, 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 substances have been shown to cause systemic
effects and reproductive toxicity in test animals.
Recommended testing: 90-day oral (gavage) subchronic study (as
described in 40 CFR 798.2650). The PMN submitter has agreed not to
exceed the production limit without performing this test.
CFR citation: 40 CFR 721.1738.
PMN Number P-94-1747
Chemical name: (generic) Halogenated alkane aromatic compound.
CAS number: Not available.
Effective date of section 5(e) consent order: February 8, 1995.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II) of TSCA
based on findings that this substance may present an unreasonable risk
of injury to health and the environment, and that the substance will be
produced in substantial quantities and there may be significant (or
substantial) human exposure to the substance.
Toxicity concern: Similar substances have been shown to cause cancer,
developmental toxicity, and reproductive toxicity in test animals, and
toxicity to fish.
Recommended testing: Incineration testing (MRI guidelines, or
comparable EPA-approved protocol) to help characterize health effects.
The PMN submitter has agreed not to exceed the production limit without
performing this test.
In addition, EPA has determined that the following tests would be
necessary
[[Page 63729]]
to evaluate possible aquatic toxicity: (1) fish bioconcentration test
(OPPTS 850.1730 test guideline), (2) fish early life stage toxicity
test (40 CFR 797.1600), (3) algal acute toxicity test (40 CFR
797.1050), (4) daphnid chronic toxicity test (40 CFR 797.1330), (5)
oyster acute toxicity test (OPPTS 850.1025 test guideline), (6)
tadpole/ sediment subchronic test (OPPTS 850.1800 test guideline), and
(7) chironamid sediment invertebrate test (OPPTS 850.1790 test
guideline). The above aquatic toxicity tests would be required on the
likely photolysis products or, in the absence of degradation, the
parent PMN substance. The following information is required to identify
the test species to be used in the above aquatic tests before testing
commences: Laboratory determination of direct photolysis reaction
quantum yield in aqueous solution and sunlight photolysis (OPPTS
835.2210 test guideline) and gas phase absorption spectra and
photolysis (OPPTS 835.2310 test guideline).
In addition, a 2-year rodent bioassay (40 CFR 798.3300) would be
necessary to evaluate the carcinogenic effects which may be caused by
the PMN substance, and a soil/sediment adsorption (adsorption isotherm)
test (40 CFR 796.2750) would be required to evaluate potential for
leaching of the PMN substance from landfills to ground water sources.
CFR citation: 40 CFR 721.785.
PMN Number P-94-2061
Chemical name: (generic) Benzotriazole derivative.
CAS number: Not available.
Effective date of section 5(e) consent order: February 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: Similar chemicals have been shown to cause systemic
toxicity (organ effects, immunotoxicity, blood effects) and
reproductive toxicity in test animals. Neurotoxicity was indicated by
acute studies on this chemical substance.
Recommended testing: A 90-day gavage study in rats (40 CFR 798.2650).
The PMN submitter has agreed not to exceed the production volume limit
without performing this test.
CFR citation: 40 CFR 721.1737.
PMN Numbers P-95-116/96-1250 and P-96-117/96-1251
Chemical name: (generic) Isothiazolinone derivatives.
CAS number: Not available.
Basis for action: The PMN substances will be used as preservatives.
Based on analogy of the substances to isothiazolones, EPA is concerned
that toxicity to aquatic organisms may occur at a concentrations as low
as 10 ppb of the PMN substances in surface waters. Based on analogy of
the substances similar substances, EPA is concerned for acute
lethality, corrosion, developmental toxicity, liver toxicity,
sensitization, and cancer to exposed workers. 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 above a concentration of 10 ppb and significant worker
exposure would not occur because the substance was not manufactured
domestically. EPA has determined that other uses of the substances may
result in releases to surface waters which exceed the concern
concentration and significant worker exposure. Based on this
information the PMN substances 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), a daphnid acute toxicity study (40 CFR
797.1300), and an algal toxicity study (40 CFR 797.1050) would help
characterize the environmental effects of the PMN substance. EPA has
determined that a developmental toxicity study (40 CFR 798.4900) and a
90-day subchronic study (40 CFR 797.2650) would help characterize the
health effects of the PMN substance.
CFR citation: 40 CFR 721.4525.
PMN Number P-95-175
Chemical name: (generic) Substituted purine metal salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a contained-use
component of a manufactured consumer article. Based on analogy to
purines and similar chemicals, EPA is concerned that toxicity to
aquatic organisms may occur at concentrations as low as 8 ppb of the
PMN substance in surface waters. EPA determined that use of the
substance did not present an unreasonable risk because because the
substance was not released to surface waters above 8 ppb. EPA has
determined that releases to surface water above 8 ppb of the substance
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), a daphnid acute toxicity study (40 CFR
797.1300), and an algal acute toxicity study (40 CFR 797.1050) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.4685.
PMN Number P-95-240
Chemical name: (generic) Azo chromium complex dyestuff preparation.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. Based on analogy to similar compounds, the PMN substance may cause
cancer, neurotoxicity, and kidney toxicity. EPA has determined that
persons exposed by inhalation to the PMN substance may be at risk for
cancer, neurotoxicity, and kidney toxicity. EPA determined that use of
the substance as a liquid did not present an unreasonable risk because
there were no significant inhalation exposures. EPA has determined that
use of the substance in a solid or powder form may result in
significant inhalation exposures. 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 798.3300) and a 90-day subchronic oral study in rats
(40 CFR 798.2650) would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.2097.
PMN Number P-95-241
Chemical name: (generic) Perfluoroalkylethyl acrylate copolymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as a water and oil
repellent. Based on analogy to perfluoro compounds, the PMN substance
may cause lung toxicity. EPA has determined that persons exposed by
inhalation to the PMN substance may be at risk for 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 in
an application that generates a vapor, mist, or aerosol 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 in rats (40 CFR
[[Page 63730]]
798.2650) would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.336.
PMN Number P-95-274
Chemical name: (generic) Phenylenebis[imino(chlorotriazinyl)
imino(substituted naphthyl)azo(substituted phenyl) azo, sodium salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a textile dye.
Based on analogy to similar substances, EPA is concerned that
respiratory sensitization will occur in exposed workers. EPA determined
that use of the substance did not present an unreasonable risk because
significant worker exposure would not occur since 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)(3)(ii).
Recommended testing: EPA has determined that a respiratory
sensitization study (Fundamental and Applied Toxicology 18:107-114)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.5930.
PMN Number P-95-284
Chemical name: (generic) Phosphoric acid derivative.
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 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), a daphnid acute toxicity study (40 CFR
797.1300) and an algal acute toxicity study (40 CFR 797.1050) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.6097.
PMN Numbers P-95-510/511
Chemical name: (generic) [(Disubstituted phenyl)]azodihydro
hydroxyalkyloxoalkyl substituted pyridines.
CAS number: Not available.
Basis for action: The PMN substances will be used as textile dyes.
Based on analogy to similar substances and submitted toxicity data, EPA
is concerned that liver toxicity, kidney toxicity, cancer, and
reproductive toxicity will occur in exposed workers. EPA determined
that use of the substances did not present an unreasonable risk because
significant worker exposure would not occur 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 substance meets 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 798.3300), a two-generation reproduction study (40 CFR
798.4700), and a 90-day subchronic oral study in rats (40 CFR 798.2650)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.8673.
PMN Number P-95-512
Chemical name: (generic) Aminofluoran derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as a color former for
carbonless copy paper. Based on analogy to neutral organic chemicals,
EPA is concerned that toxicity to aquatic organisms may occur at
concentrations 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 environmental exposure would not
occur since the substance was not manufactured domestically. EPA has
determined that domestic manufacture of the substance 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 chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600) and a
21-day chronic daphnid toxicity test (40 CFR 797.1330) would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.646.
PMN Number P-95-513
Chemical name: (generic) N-[2-[(substituted
dinitrophenyl)azo]diallylamino-4-substituted phenyl] acetamide.
CAS number: Not available.
Basis for action: The PMN substance will be used a colorant. Based on
analogy to similar substances, 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 would not occur 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)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that a 2-year two-species oral
bioassay (40 CFR 798.3300), a developmental toxicity test (40 CFR
798.4900) and a 90-day subchronic oral study in rats (40 CFR 798.2650)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.267.
PMN Number P-95-514
Chemical name: (generic) Substituted diphenylazo dye.
CAS number: Not available.
Basis for action: The PMN substances will be used as a dye. Based on
analogy to similar substances, EPA is concerned that liver toxicity,
blood toxicity, oncogenicity, 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 would not occur 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 substance meets the concern criteria at
Sec. 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that a 2-year two-species oral
bioassay (40 CFR 798.3300), a developmental toxicity test (40 CFR
798.4900) and a 90-day subchronic oral study in rats (40 CFR 798.2650)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2527.
PMN Number P-95-529
Chemical name: (generic) Alkaline titania silica gel.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based
[[Page 63731]]
on potential silicosis, EPA is concerned that lung effects will 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)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study (40 CFR 798.2650) with a 60-day holding period would
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.9680.
PMN Number P-95-538
Chemical name: 2-Naphthalenol, heptyl-1-[[(4-phenylazo)phenyl] azo]-,
ar',ar''-Me derivs.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant in high
sulfur diesel fuel. Based on data on the potential diaminoazo reduction
product and by analogy to similar chemicals, EPA is concerned that
reproductive effects and cancer 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)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that a 2-year two-species oral
bioassay (40 CFR 798.3300) and a two-generation reproductive toxicity
study (40 CFR 798.4700) would help characterize the human health
effects of the PMN substance.
CFR citation: 40 CFR 721.5276.
PMN Numbers P-95-655, P-95-782, and P-95-871
Chemical name: (generic) Substituted phenyl azo substituted phenyl
esters.
CAS number: Not available.
Basis for action: The PMN substances will be used as textile dyes.
Based on analogy to similar substances and submitted toxicity data, EPA
is concerned that liver toxicity, blood toxicity, oncogenicity, kidney
toxicity, and sensitization will occur in exposed workers. EPA
determined that use of the substances did not present an unreasonable
risk because the substances would not be manufactured as a powder and
significant worker exposure would not occur. EPA has determined that
manufacture 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)(C), (b)(3)(ii), and
(b)(3)(iii).
Recommended testing: EPA has determined that a 2-year two-species oral
bioassay (40 CFR 798.3300) and a 90-day subchronic oral study in rats
(40 CFR 798.2650) would help characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.3063.
PMN Numbers P-95-979/980/981
Chemical name: Fluorinated carboxylic acid alkali metal salts.
CAS number: Not available.
Basis for action: The PMN substances will be used as intermediates.
Based on analogy of the PMN substances to anionic surfactants and
perfluorinated fatty acids, EPA expects toxicity to aquatic organisms
at surface water concentrations as low as 100 ppb for P-95-979, 30 ppb
for P-95-980, and 3 ppb for P-95-981. EPA expects liver toxicity based
on analogy to a structurally similar substance, developmental toxicity
based on branched carboxylic acids, and lung toxicity due to
surfactancy. EPA determined that use of the substances as described in
the PMN did not present an unreasonable risk because there were no
significant inhalation exposures or environmental releases. EPA has
determined that other uses of the substances may result in significant
inhalation or environmental exposures. Based on this information the
PMN substances meet the concern criteria at Sec. 721.170 (b)(3)(ii) and
(b)(4)(iii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation assay (40 CFR 798.2450) would help characterize the health
effects of the PMN substances and a fish acute toxicity study (40 CFR
797.1400), a daphnid acute toxicity study (40 CFR 797.1300) and an
algal acute toxicity study (40 CFR 797.1050) would help characterize
the environmental effects of the PMN substances.
CFR citation: 40 CFR 721.4663.
PMN Number P-95-1022
Chemical name: (generic) Polyester silane.
CAS number: Not available.
Basis for action: The PMN substance will be used as described in the
PMN. 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 industrial uses of the substance 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 assay (40 CFR 798.2450) would help characterize the health
effects of the PMN substance.
CFR citation: 40 CFR 721.9507.
PMN Numbers P-95-1024/1040
Chemical name: (generic) Acrylosilane resins.
CAS number: Not available.
Basis for action: The PMN substances will be used as described in the
PMN. Based on analogy of the PMN substances to alkoxysilanes, EPA
expects irritation to mucous membranes and lung toxicity. EPA
determined that use of the substances as described in the PMN did not
present an unreasonable risk because there were no significant
inhalation exposures. EPA has determined that nonindustrial uses of the
substances may result in significant inhalation exposures. Based on
this information the PMN substances meet the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation assay (40 CFR 798.2450) would help characterize the health
effects of the PMN substances.
CFR citation: 40 CFR 721.9495.
PMN Number P-95-1030
Chemical name: (generic) o-Xylene compound.
CAS number: Not available.
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 liver, kidney, thyroid, and developmental toxicity
and chronic toxicity to aquatic organisms. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because significant human or environmental exposure would not
occur. EPA has determined that use of the substance other than as
described in the PMN may result in significant human or environmental
[[Page 63732]]
exposure. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170 (b)(3)(i) and (b)(4)(i).
Recommended testing: EPA has determined that a 28-day contaminated
sediment test with chironomids and natural sediments would help
characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9970.
PMN Number P-95-1208
Chemical name: (generic) Fluorinated acrylic copolymer.
CAS number: Not available.
Basis for action: The PMN substance will be used as a soil repellant.
Based on the molecular weight and physical properties of the substance,
EPA is concerned that a significant risk of lung toxicity would occur.
EPA determined that use of the substance did not present an
unreasonable risk because the substance would not be manufactured,
processed, or used as a powder or an aerosol and significant worker
inhalation exposure would not occur. EPA has determined that
manufacture, processing, or use of the substance as a powder or an
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) would help characterize the
health effects of the PMN substance.
CFR citation: 40 CFR 721.484.
PMN Number P-95-1242
Chemical name: (generic) Chromate(3-), bis 2-[[substituted-3-[(5sulfo-
1-naphthalenyl)
azo]phenyl]azo]substituted monocycle, trisodium.
CAS number: Not available.
Basis for action: The PMN substance will be used as a leather dye.
Based on potential azo reduction products, EPA is concerned that blood
toxicity, oncogenicity, mutagenicity, 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 would not occur because the substance was not
manufactured domestically or in the form of a powder. EPA has
determined that domestic manufacture of the substance or any 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 2-year two-species oral
bioassay (40 CFR 798.3300), a developmental toxicity study (40 CFR
798.4900), and a 90-day subchronic oral study in rats (40 CFR 798.2650)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2095.
PMN Number P-96-175
Chemical name: Lithium Manganese Oxide (LiMn204)
CAS number: Not applicable.
Effective date of section 5(e) consent order: April 17, 1996.
Basis for section 5(e) consent order: The order was issued under
section 5 (e)(1)(A)(i), (e)(1)(A)(ii)(I), and (e)(1)(A)(ii)(II), of
TSCA based on findings that this substance is expected to be produced
in substantial quantities and there may be significant or substantial
human exposure to the substances.
Recommended testing: EPA has determined that a sediment and soil
adsorption isotherm test (40 CFR 796.2750) and a 90-day subchronic
study via the inhalation route with a 60-day holding period (40 CFR
798.2450). The PMN submitter has agreed not to exceed the production
volume limit without performing these tests.
CFR citation: 40 CFR 721.4587.
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 19 of the 45
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, 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 section 5(e) orders.
In the other 26 cases for which the proposed uses are not regulated
under a 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,
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 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 January 31, 1997, unless
EPA receives a written notice by January 2, 1997 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 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 section 5(e)
[[Page 63733]]
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 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 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. 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. Section 5(e) orders have been
issued for 19 substances and notice submitters are prohibited by the
section 5(e) orders from undertaking activities which EPA is
designating as significant new uses. In cases where EPA has not
received a notice of commencement (NOC) and the substance has not been
added to the Inventory, no other person may commence such activities
without first submitting a PMN. For substances for which an NOC has not
been submitted at this time, EPA has concluded that the uses are not
ongoing. However, EPA recognizes in cases when chemical substances
identified in this SNUR are added to the Inventory prior to the
effective date of the rule, the substances may be manufactured,
imported, or processed by other persons for a significant new use as
defined in this rule before the effective date of the rule. However, 39
of the 45 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) (FRL-3658-5), 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
[[Page 63734]]
public record for this rule (OPPTS-50623).
X. Rulemaking Record
A record has been established for this rulemaking under docket
number OPPTS-50623 (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, except legal holidays.
The public record is located in the TSCA Nonconfidential Information
Center Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
XI. Regulatory Assessment Requirements
Under Executive Order 12866 (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 require prior consultation with State officials as specified
by Executive Order 12875 (58 FR 58093, October 28, 1993), nor does it
involve special considerations of environmental justice related issues
as required by Executive Order 12898 (59 FR 7629, February 16, 1994).
This action will not result in the annual expenditure of $100
million or more for State, local, and tribal governments, in the
aggregate, or to the private sector, and is not a Federal mandate, as
defined by the Unfunded Mandates Reform Act of 1995 (UMRA)(Pub. L. 104-
4), nor does it uniquely affect small govbernments in any way. As such,
the requirements of sections 202, 203, and 205 of Title II of the UMRA
do not apply to this action.
EPA has determined that this action does not impose any adverse
economic impacts on a substantial number of small entities. Pursuant
section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.). The Agency has certified that this action will not impose a
significant economic impact on a substantial number of small entities.
Information relating to this determination is included in the docket
for this rulemaking. Any comments regarding the economic impacts that
this action imposes on small entities should be submitted to the Agency
at the address listed above.
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to, an information collection request unless it
displays a currently valid control number assigned by OMB. The OMB
control numbers for EPA's regulations are listed in 40 CFR part 9 and
48 CFR chapter 15. The information collection requirements related to
this action have already been approved by OMB under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burdens
requiring additional OMB approval. The public reporting burden for this
collection of information is estimated to average 100 hours per
response. The burden estimate includes the time needed for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
XII. Submission to Congress and the General Accounting Office
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2)
of the Administrative Procedure Act. Pursuant to 5 U.S.C. 801(a)(1)(A),
EPA submitted this action to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the General Accounting
Office prior to its publication in today's Federal Register.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements.
Dated: November 21, 1996.
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. 721.267 to subpart E to read as follows:
Sec. 721.267 N-[2-[(substituted dinitrophenyl)azo]diallylamino-4-
substituted phenyl] acetamide (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as N-[2-
[(substituted dinitrophenyl)azo]diallylamino-4-substituted phenyl]
acetamide (PMN P-95-513) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
3. By adding new Sec. 721.336 to subpart E to read as follows:
Sec. 721.336 Perfluoroalkylethyl acrylate copolymer (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
perfluoroalkylethyl acrylate copolymer (PMN P-94-241) 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.
4. By adding new Sec. 721.484 to subpart E to read as follows:
[[Page 63735]]
Sec. 721.484 Fluorinated acrylic copolymer (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
fluorinated acrylic copolymer (PMN P-95-1208) 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)(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.
5. By adding new Sec. 721.646 to subpart E to read as follows:
Sec. 721.646 Aminofluoran derivative (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aminofluoran derivative (PMN P-95-512) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
6. By adding new Sec. 721.785 to subpart E to read as follows:
Sec. 721.785 Halogenated alkane aromatic compound (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
halogenated alkane aromatic compound (PMN P-94-1747) 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)(iv), (a)(5)(v), (6)(i), (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)(vii), (g)(2)(iv), (g)(2)(v), (g)(3)(ii), (g)(4)(iii), and
(g)(5).
(iii) Industrial, commercial, and consumer activites. Requirements
as specified in Sec. 721.80(q).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
7. By adding new Sec. 721.979 to subpart E to read as follows:
Sec. 721.979 l-Aspartic acid, homopolymer and ammonium and potassium
salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances l-Aspartic acid, homopolymer and
ammonium and potassium salts (P-91-1299 and P-95-1667, P-91-1298, and
P-91-1297) (CAS Nos. 25608-40-6 and 64723-18-8) 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. A significant new use of these
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 section 5(e)
consent order for these substances, the employer becomes aware that
these substances may present a risk of injury to human health or the
environment the employer must incorporate this new information, and any
information on methods for protecting against such risk, into a
Material Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within
90 days from the time the employer becomes aware of the new
information. If these substances are 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 their substances from the employer within 5 years from
the date the employer becomes aware of the new information described in
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as
described in Sec. 721.72(c) containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) 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), (h), 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) 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. 721.1737 to subpart E to read as follows:
Sec. 721.1737 Benzotriazole derivative.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a benzotriazole
derivative (PMN P-94-2061) 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), and (b)(concentration set at 5.0 percent) and (c).
The following paragraphs apply during manufacturing and processing:
(a)(5)(ii), (a)(5)(iv), and (a)(5)(v). The following paragraphs apply
during use: (a)(5)(iii), (a)(5)(viii), (a)(5)(ix), (a)(5)(x),
(a)(5)(xi), and (a)(6)(ii).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e)(concentration set at 5.0 percent),
(f), (g)(1)(vi), (g)(2)(ii),
[[Page 63736]]
(g)(2)(iii), and (g)(2)(iv). The following additional statements shall
appear on each label and MSDS required by this paragraph: This
substance may cause kidney effects. This substance may cause liver
effects. This substance may cause neurotoxicity effects. This substance
may cause blood effects.
(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) and (b)(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), (j) and (k) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
9. By adding new Sec. 721.1738 to subpart E to read as follows:
Sec. 721.1738 Substituted benzotriazole (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted benzotriazole (PMN P-94-1744) 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)(6)(i),
(b) (concentration set at 1.0%), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0%), (f),
(g)(1)(iv), (g)(1)(vi), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv),
(g)(2)(v), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements specified in
Sec. 721.125(a) through (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.
10. By adding new Sec. 721.2095 to subpart E to read as follows:
Sec. 721.2095 Chromate(3-), bis 2-[[substituted-3-[(5-sulfo-1-
naphthalenyl)azo]phenyl]azo]substituted monocycle, trisodium (generic
name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
chromate(3-), bis 2-[[substituted-3-[(5-sulfo-1-naphthalenyl)
azo]phenyl]azo]substituted monocycle, trisodium (PMN P-95-1242) 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 (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.
11. By adding new Sec. 721.2097 to subpart E to read as follows:
Sec. 721.2097 Azo chromium complex dyestuff preparation (generic
name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an azo
chromium complex dyestuff preparation (PMN P-95-240) 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), (v)(2), (w)(1), (w)(2), (x)(1), and
(x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
12. By adding new Sec. 721.2527 to subpart E to read as follows:
Sec. 721.2527 Substituted diphenylazo dye (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted diphenylazo dye (PMN P-95-514) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(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. 721.3063 to subpart E to read as follows:
Sec. 721.3063 Substituted phenyl azo substituted phenyl esters
(generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted phenyl azo substituted phenyl esters (PMNs P-95-655, P-95-
782 and P-95-871) 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(w)(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) 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 significant new use rule.
14. By adding new Sec. 721.3628 to subpart E to read as follows:
[[Page 63737]]
Sec. 721.3628 Fatty acids, C(14-18)-unsaturated, branched and linear,
methyl and butyl esters.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances fatty acids, C(14-18)
unsaturated, branched and linear, methyl and butyl esters (P-94-1634/
35/36/37/38/39) 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. A significant new use of this
substance is any manner or method of manufacture, import, or processing
associated with any use of this substance without providing risk
notification as follows:
(A) If as a result of the test data required under the 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
Material Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within
90 days from the time the employer becomes aware of the new
information. If this 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 substance is reintroduced
into the workplace.
(B) The employer must ensure that persons who will receive, or who
have received this 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.
(ii) 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), (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.
15. By adding new Sec. 721.4484 to subpart E to read as follows:
Sec. 721.4484 Halogenated indane (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
halogenated indane (PMN P-94-351) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section. The requirements of this section do not apply to P-94-351
after incorporation into a plastic, resin matrix, or pelletized so
humans are not reasonally likely to be exposed.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements during manufacture as
specified in Sec. 721.72 (a)(5)(iii), (a)(5)(iv), (a)(5)(v),
(a)(5)(vi), (a)(5(vii), (a)(6)(i), (b) (concentration set at 0.1
percent), and (c).
(ii) Hazard communication program. Requirements during manufacture
as specified in Sec. 721.63 (a), (b), (c), (d), (e), (f), (g)(1)(vii),
(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).
(b) Specific requirements. The provisions of subpart A of this 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.
16. By adding new Sec. 721.4494 to subpart E to read as follows:
Sec. 721.4494 Polycyclic isocyanate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a polycyclic
isocyanate (PMN P-94-437) 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)(ii),
(a)(6)(iii), (a)(6)(iv), (a)(6)(v), (a)(6)(vi), (b) (concentration set
at 1.0%), 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), (g)(3)(i), (g)(3)(ii), (g)(4)(i), and (g)(5). In
addition the following human health and environmental hazard and
precautionary statements shall appear on each label as specified in
paragraph (b) of this section and the MSDS as specified in paragraph
(c) of this section: This substance may cause skin sensitization. This
substance may cause pulmonary sensitization.
(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)(3), (b)(3), and (c)(3).
(b) Specific requirements. The provisions of subpart A 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) 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.
17. By adding new Sec. 721.4497 to subpart E to read as follows:
Sec. 721.4497 Aliphatic polyisocyanates (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
aliphatic polyisocyanates (P-91-1210 and P-92-714) are 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)(1), (a)(2)(i), (a)(2)(iii), (a)(3), (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), (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
[[Page 63738]]
implement the product stewardship provisions of the section 5(e)
consent order for these substances are exempt from the requirements of
Secs. 721.63 and 721.72.
(b) Specific requirements. The provisions of subpart A 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. Manufacturers, importers,
and processors who implement the product stewardship provisions or keep
records as required by the 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) 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 section 5(e) consent order for
these substances.
18. By adding new Sec. 721.4525 to subpart E to read as follows:
Sec. 721.4525 Isothiazolinone derivatives (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
isothiazolinone derivatives (PMNs P-95-116/117) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where n = 10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
19. By adding new Sec. 721.4587 to subpart E to read as follows:
Sec. 721.4587 Lithium Manganese Oxide (LiMn204) (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as lithium
manganese oxide (LiMn204) (P-96-175) 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. 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 section 5(e)
consent order for these substances, the employer becomes aware that
these substances may present a risk of injury to human health or the
environment the employer must incorporate this new information, and any
information on methods for protecting against such risk, into a
Material Safety Data Sheet (MSDS) as described in Sec. 721.72(c) within
90 days from the time the employer becomes aware of the new
information. If these substances are 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 their substances from the employer within 5 years from
the date the employer becomes aware of the new information described in
paragraph (a)(2)(i)(A) of this section, are provided an MSDS as
described in Sec. 721.72(c) containing the information required under
paragraph (a)(2)(i)(A) of this section within 90 days from the time the
employer becomes aware of the new information.
(ii) 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), (h), 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) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
20. By adding new Sec. 721.4663 to subpart E to read as follows:
Sec. 721.4663 Fluorinated carboxylic acid alkali metal salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as fluorinated
carboxylic acid alkali metal salts (PMNs P-95-979/980/981) 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 (v)(2), (w)(2), and (x)(2).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4), (N = 100 ppb for P-95-979), (N = 30 ppb for
P-95-980), and (N = 3 ppb for P-95-981).
(b) Specific requirements. The provisions of subpart A of this 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.
21. By adding new Sec. 721.4668 to subpart E to read as follows:
Sec. 721.4668 Hydrated alkaline earth metal salts of metalloid
oxyanions.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as hydrated alkaline
earth metal salts of metalloid oxyanions (PMN P-94-1557) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi),
(a)(5)(vii), (a)(5)(viii), (a)(6)(i), (b), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e), (f), (g)(1)(vi), (g)(1)(ix),
(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).
(b) Specific requirements. The provisions of subpart A of this 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.
[[Page 63739]]
(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.
22. By adding new Sec. 721.4685 to subpart E to read as follows:
Sec. 721.4685 Substituted purine metal salt (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted purine metal salt (PMN P-95-175) 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 = 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.
23. By adding new Sec. 721.5276 to subpart E to read as follows:
Sec. 721.5276 2-Naphthalenol, heptyl-1-[[(4-phenylazo)phenyl]azo]-,
ar',ar''-Me derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-naphthalenol,
heptyl-1-[[(4-phenylazo)phenyl] azo]-, ar',ar''-Me derivs (PMN P-95-
538) 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. 721.5545 to subpart E to read as follows:
Sec. 721.5545 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyl-
oxazolidine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3-(dichloroacetyl)-
5-(2-furanyl)-2,2-dimethyloxazolidine (PMN P-93-1694) (CAS no. 121776-
57-6) 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) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(3), (a)(4), (a)(5)(i), (a)(6)(i), (b)
(concentration set at 0.1%), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1%), (f),
(g)(1)(iv), (g)(1)(vii), (g)(1)(ix), (g)(2)(iii), (g)(2)(iv),
(g)(2)(v), (g)(3)(i), (g)(3)(ii), and (g)(5).
(iii) Industrial, commercial, and consumer activites. Requirements
as specified in Sec. 721.80 (b), (c), (k) (as a seed safener), and (o).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (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.
25. By adding new Sec. 721.5930 to subpart E to read as follows:
Sec. 721.5930 Phenylenebis[imino (chlorotriazinyl)imino(substituted
naphthyl)azo(substituted phenyl)azo, sodium salt (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenylenebis[imino (chlorotriazinyl)imino(substituted naphthyl)azo
(substituted phenyl) azo, sodium salt (PMN P-95-274) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
26. By adding new Sec. 721.6097 to subpart E to read as follows:
Sec. 721.6097 Phosphoric acid derivative (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
phosphoric acid derivative (PMN P-95-284) 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. 721.8673 to subpart E to read as follows:
Sec. 721.8673 [(Disubstituted phenyl)]azo dihydro hydroxy alkyl oxo
alkyl-substituted-pyridines (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
[(disubstituted phenyl)]azo dihydro hydroxy alkyl oxo alkyl-
substituted-pyridines (PMN P-95-510/511) 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
[[Page 63740]]
(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 significant new use rule.
28. By adding new Sec. 721.9495 to subpart E to read as follows:
Sec. 721.9495 Acrylosilane resins.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as acrylosilane
resins (PMNs P-95-1024/1040) 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(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.
29. By adding new Sec. 721.9507 to subpart E to read as follows:
Sec. 721.9507 Polyester silane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as a polyester silane
(P-95-1022) 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.
30. By adding new Sec. 721.9680 to subpart E to read as follows:
Sec. 721.9680 Alkaline titania silica gel (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an
alkaline titania silica gel (PMN P-95-529) 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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this significant new use rule.
31. By adding new Sec. 721.9970 to subpart E to read as follows:
Sec. 721.9970 o-Xylene compound (generic name).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as an o-
xylene compound (PMN P-95-1030) 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.
[FR Doc. 96-30474 Filed 11-29-96; 8:45 am]
BILLING CODE 6560-50-F