[Federal Register Volume 63, Number 161 (Thursday, August 20, 1998)]
[Rules and Regulations]
[Pages 44562-44583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22441]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50632; FRL-5788-7]
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 73
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 October 19, 1998. This rule
shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.)
on September 3, 1998.
If EPA receives notice before October 19, 1998 that someone wishes
to submit adverse or critical comments on EPA's action in establishing
a SNUR for one or more of the chemical substances subject to this rule,
EPA will withdraw the SNUR for the substance for which the notice of
intent to comment is received and will issue a proposed SNUR providing
a 30-day period for public comment.
ADDRESSES: Each comment or notice of intent to submit adverse or
critical comment must bear the docket control number OPPTS-50632 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 St., SW., Rm. G-099, East Tower, Washington,
DC 20460.
Comments and data may also be submitted electronically to:
oppt.ncic@epa.gov. Follow the instructions under Unit X. of this
document. No Confidential Business Information (CBI) should be
submitted through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this rulemaking. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each portion. This claim must be
made at the time that the information is submitted to EPA . If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-531, 401
M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202)
554-0551; e-mail: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document are
available from the EPA Home Page at the Federal Register-Environmental
Documents entry for this document under ``Laws and Regulations''
(http://www.epa.gov/fedrgstr/).
This SNUR will require persons to notify EPA at least 90 days
before commencing manufacturing or processing a substance for any
activity designated by this SNUR as a significant new use. The
supporting rationale and background to this rule are more fully set out
in the preamble to EPA's first direct final SNURs published in the
Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble
for further information on the objectives, rationale, and procedures
for the rules and on the basis for significant new use designations
including provisions for developing test data.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a
[[Page 44563]]
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 TSCA section 5(b) and
5(d)(1), the exemptions authorized by TSCA section 5 (h)(1), (2), (3),
and (5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUR notice, EPA may take regulatory action under TSCA section 5 (e),
5(f), 6, or 7 to control the activities on which it has received the
SNUR notice. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret TSCA section 12(b) appear
at 40 CFR part 707. Persons who intend to import a chemical substance
identified in a final SNUR are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Such persons must certify that they are in
compliance with SNUR requirements. The EPA policy in support of the
import certification appears at 40 CFR part 707.
III. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for the following chemical substances under 40 CFR part
721, subpart E. In this unit, EPA provides a brief description for each
substance, including its PMN Number, chemical name (generic name if the
specific name is claimed as CBI), CAS number (if assigned for non-
confidential chemical identities), basis for the action taken by EPA in
the TSCA section 5(e) consent order or as a non-section 5(e) SNUR for
the substance (including the statutory citation and specific finding),
toxicity concern, and the CFR citation assigned in the regulatory text
section of this rule. The specific uses which are designated as
significant new uses are cited in the regulatory text section of this
document by reference to 40 CFR part 721, subpart E where the
significant new uses are described in detail. Certain new uses,
including production limits and other uses designated in the rule are
claimed as CBI. The procedure for obtaining confidential information is
set out in Unit VII. of this preamble.
Where the underlying TSCA section 5(e) consent order prohibits the
PMN submitter from exceeding a specified production limit without
performing specific tests to determine the health or environmental
effects of a substance, the tests are described in this unit. As
explained further in Unit VI. of this preamble, the SNUR for such
substances contains the same production limit, and exceeding the
production limit is defined as a significant new use. Persons who
intend to exceed the production limit must notify the Agency by
submitting a significant new use notice (SNUN) at least 90 days in
advance. In addition, this unit describes tests that are recommended by
EPA to provide sufficient information to evaluate the substance, but
for which no production limit has been established in the TSCA section
5(e) consent order. Descriptions of recommended tests are provided for
informational purposes.
Data on potential exposures or releases of the substances, testing
other than that specified in the TSCA section 5(e) consent order for
the substances, or studies on analogous substances, which may
demonstrate that the significant new uses being reported do not present
an unreasonable risk, may be included with significant new use
notification. Persons submitting a SNUN must comply with the same
notice requirements and EPA regulatory procedures as submitters of
PMNs, as stated in 40 CFR 721.1(c), including submission of test data
on health and environmental effects as described in 40 CFR 720.50.
EPA is not publishing SNURs for PMNs P-95-2040, P-97-77, P-97-118,
P-97-214, P-98-5/6/7/8/9/10 which are subject to a final TSCA section
5(e) consent order. The TSCA section 5(e) consent orders for these
substances are derived from an exposure finding based solely on
substantial production volume and significant or substantial human
exposure and/or release to the environment of substantial quantities.
For these cases there were limited or no toxicity data available for
the PMN substances. In such cases, EPA regulates the new chemical
substances under TSCA section 5(e) by requiring certain toxicity tests.
For instance, chemical substances with potentially substantial releases
to surface waters would be subject to toxicity testing of aquatic
organisms and chemicals with potentially substantial human exposures
would be subject to health effects testing for mutagenicity, acute
effects, and subchronic effects. However, for these substances, the
short-term toxicity testing required by the TSCA section 5(e) consent
order is usually completed within 1 to 2 years of notice of
commencement. EPA's experience with exposure-based SNURs requiring
short-term testing is that the SNUR is often revoked within 1 to 2
years when the test results are received. Rather than issue and revoke
SNURs in such a short span of time, EPA will defer publication of
exposure-based SNURs until either a notice of commencement (NOC) or
data demonstrating risk are received unless the toxicity testing
required is long-term. EPA is issuing this explanation and notification
as required in 40 CFR 721.160(a)(2) as it has determined that SNURs are
not needed at this time for these substances which are subject to a
final section 5(e) consent order under TSCA.
PMN Numbers P-93-880/881
Chemical names: Amines, N-cocoalkyltrimethylenedi-, citrates (P-93-
880); Amines, N-tallowalkyltripropylenetetra-, citrates (P-93-881).
CAS number: 189120-63-6 (P-93-880); 189120-62-5 (P-93-881).
Effective date of section 5(e) consent order: September 4, 1997.
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) of TSCA
based on a finding that these substances may present an unreasonable
risk of injury to the environment, that the PMN substances will be
produced in substantial quantities, and there may be significant or
substantial environmental exposure to the substances.
Toxicity concern: Based on test data for the substances and test data
on structurally similar aliphatic amines, there is concern for toxicity
to aquatic organisms at concentrations as low as 2 parts per billion
(ppb) in surface waters.
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a fish acute toxicity
mitigated by dissolved organic carbon (humic acid
[[Page 44564]]
test) (OPPTS 850.1085 test guideline (public draft; 61 FR 16486, April
15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR
797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citations: 40 CFR 721.7285 (P-93-880); 40 CFR 721.7286 (P-93-881).
PMN Number P-95-1098
Chemical name: (generic) Tris carbamoyl triazine.
CAS number: Not available.
Effective date of section 5(e) consent order: April 25, 1997.
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 the environment, that the PMN substance will be produced
in substantial quantities, and there may be significant or substantial
human exposure to the substance.
Toxicity concern: Based on test data for the substance, there is
concern for toxicity to aquatic organisms at concentrations as low as
40 ppb in surface waters. The health testing required in the order is
based on the exposure based finding pursuant to section
5(e)(1)(A)(ii)(II) of TSCA.
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996)) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. The PMN submitter has
agreed to conduct a prenatal developmental toxicity study by the oral
route in one-species (40 CFR 799.9370) (62 FR 43832, August 15, 1997)
(FRL-5719-5) before exceeding the production volume limit.
CFR citation: 40 CFR 721.9719.
PMN Numbers P-96-756/757/758
Chemical names: (generic) 1-Piperidinecarboxylic acid, 2-[(dichloro-
hydroxy-carbomonocycle)hydrazono]-, methyl ester (P-96-756); (generic)
Dichloro, hydroxy, hydrazino-carbomonocycle (P-96-757); (generic)
Dichloro, hydroxy, hydrazino-carbomonocycle-monohydrochloride (P-96-
758).
CAS number: Not available.
Effective date of section 5(e) consent order: August 29, 1997.
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) of TSCA
based on a finding that the substances may present an unreasonable risk
of injury to health, that the substances are expected to be produced in
substantial quantities, and there may be significant or substantial
human exposure to the substances.
Toxicity concern: Structurallyt similar chemicals have been shown to
cause effects to internal organs and cancer in test animals.
Recommended testing: A 90-day oral subchronic toxicity in rats (40 CFR
798.2650 or OPPTS 870.3100 test guideline (63 FR 41845, August 5, 1998)
(FRL-5740-1)) and a two-species carcinogenicity study (40 CFR 799.9420)
(62 FR 43838, August 15, 1997) (FRL-5719-5) are recommended to help
characterize health effects. The PMN submitter has agreed not to exceed
the production volume limit without performing the 90-day oral
subchronic toxicity test for P-96-756.
CFR citations: 40 CFR 721.2078 (P-96-756); 40 CFR 721.2079 (P-96-757);
40 CFR 721.2081 (P-96-758).
PMN Number P-96-1006
Chemical name: 1,3-Dioxolane, 2-ethenyl-.
CAS number: 3984-22-3.
Effective date of section 5(e) consent order: May 1, 1997.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to human
health.
Toxicity concern: Based on submitted acute toxicity testing by the
dermal (LD50 = 25.1 milligram/kilogram (mg/kg)) and oral
(LD50 = 84.7 mg/kg) routes, exposure to the substance may
result in fatality, central nervous system effects, liver toxicity, and
irritation to the skin and eyes.
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-
5719-5) and a 90-day subchronic dermal study (40 CFR 798.2250 or OPPTS
870.3250 test guideline (63 FR 41845, August 5, 1998) (FRL-5740-1))
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.2485.
PMN Number P-96-1320
Chemical name: (generic) Isoalkyldimethylamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on structure activity analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 3 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters in significant quantities. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.2480.
PMN Numbers P-96-1425/1426
Chemical names: (generic) Salt of a modified tallow alkylenediamine (P-
96-1425); salt of a fatty alkylamine derivative (P-96-1426).
CAS number: Not available.
Basis for action: The PMN substances will be used as processing aids.
Based on structure activity analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substances in surface waters.
EPA determined that use of the substances as described in the PMNs did
not present an unreasonable risk because the substances would not be
released to surface waters. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline public draft;
61
[[Page 44565]]
FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study
(40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study
(40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citations: 40 CFR 721.630 (P-96-1425); 40 CFR 721.558 (P-96-1426).
PMN Number P-96-1428
Chemical name: (generic) Modified polyisocyanates.
CAS number: Not available.
Effective date of section 5(e) consent order: July 7, 1997.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding
that this substance may present an unreasonable risk of injury to
health.
Toxicity concern: Structurally similar chemicals have been shown to
cause skin irritation and allergic reactions, respiratory irritation
and sensitization, and lung toxicity in test animals.
Recommended testing: A 90-day subchronic inhalation toxicity study in
rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) will
help the Agency to characterize the human health effects of the PMN
substance. The PMN submitter has agreed not to exceed the production
volume limit without performing the 90-day study.
CFR citation: 40 CFR 721.6498.
PMN Number P-96-1520
Chemical name: Octadecanoic acid, ester with 1,2-propanediol,
phosphate, anhydride with silicic acid (H4SiO4).
CAS number: 177771-31-2.
Effective date of section 5(e) consent order: July 8, 1997.
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 the environment, that this substance is expected to be
produced in substantial quantities, and there may be significant or
substantial environmental exposure to the substance.
Toxicity concern: Structurally similar chemicals have been shown to
cause toxicity in aquatic organisms.
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. The PMN submitter has
agreed not to exceed the production volume limit without performing
these tests.
CFR citation: 40 CFR 721.3635.
PMN Number P-97-4
Chemical name: (generic) Substituted diphenylmethane.
CAS number: Not available.
Basis for action: The PMN substance will be used as a raw material for
manufacture of light stabilizers. Based on submitted test data, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 10 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meets the concern criteria at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40
CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.2532.
PMN Numbers P-97-42/43
Chemical name: (generic) Phenylazoalkoxy naphthylamines.
CAS number: Not available.
Basis for action: The PMN substances will be used as petroleum
additives. Based on structual activity analogy to neutral organics, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 50 ppb for P-97-42 and 40 ppb for P-97-43 in
surface waters. EPA determined that use of the substances as described
in the PMNs did not present an unreasonable risk because the substances
would not be released to surface waters in significant quantities. EPA
has determined that other uses of the substances may result in releases
to surface waters which exceed the concern concentration. Based on this
information the PMN substances meet the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.5290.
PMN Numbers P-97-93/94
Chemical names: (generic) Di-substituted acetophenone (P-97-93);
(generic) Di-substituted propanedione (P-97-94).
CAS number: Not available.
Effective date of section 5(e) consent order: June 9, 1997.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding
that these substances may present an unreasonable risk of injury to
health.
Toxicity concern: Based on submitted test data for P-97-94 the
substances may cause liver, kidney, adrenal gland, and heart toxicity
in test animals.
Recommended testing: EPA has determined that a glove permeation study
according to American Society for Testing and Materials (ASTM) F739, an
in vitro dermal absorption study published in the Federal Register on
April 3, 1996 (61 FR 14773) (FRL-5359-3) and a 90-day gavage study in
rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (63 FR 41845,
August 5, 1998) (FRL-5740-1)) would help characterize the health
effects of the PMN substance. The PMN submitter has agreed not to
exceed the production volume limit without performing these tests.
CFR citations: 40 CFR 721.305 (P-97-93); 40 CFR 721.8153 (P-97-94).
PMN Numbers P-97-179/783, P-97-181/781, P-97-189/769, and P-97-775/782
Chemical name: (generic) Zirconium dichlorides.
CAS number: Not available.
Basis for action: The PMN substances will be used as polymerization
catalysts.
[[Page 44566]]
Based on structural activity analogy to organo zirconium compounds, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substances in surface waters.
EPA determined that use of the substances as described in the PMNs did
not present an unreasonable risk because the substances would not be
released to surface waters in significant quantities. EPA has
determined that other uses of the substances may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substances meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.9973.
PMN Numbers P-97-296/297/298/299
Chemical name: (generic) Alkyl benzene sulfonic acids and alkyl
sulfates, amine salts.
CAS number: Not available.
Basis for action: The PMN substances will be used as polymerization
catalysts. Based on submitted test data and structural activity analogy
to anionic surfactants, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 30 ppb of the PMN
substances in surface waters. EPA determined that use of the substances
as described in the PMN did not present an unreasonable risk because
the substances would not be released to surface waters in significant
quantities. EPA has determined that other uses of the substances may
result in releases to surface waters which exceed the concern
concentration. Based on this information the PMN substances meets the
concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996)(FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.9595.
PMN Number P-97-332
Chemical name: Siloxanes and silicones, de-Me, 3-[4-[[[3(dimethylamino)
propyl]amino] carbonyl]-2-oxo-1-pyrrolidinyl] propyl Me.
CAS number: 179005-02-8.
Basis for action: The PMN substance will be used as an intermediate in
a multiple step synthesis. Test data on structurally similar chemical
substances which the Agency has received under section 8(e) of TSCA
raised concerns for lung toxicity. EPA determined that use of the PMN
substance as an intermediate as described in the PMN did not present an
unreasonable risk because workers would not be subject to significant
inhalation exposures. However, EPA has identified other potential uses
which may result in significant inhalation exposures to workers. Based
on this information the PMN substance meets the concern criteria at
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of an acute
inhalation toxicity test in rats (OPPTS 870.1300 test guideline (63 FR
41845, August 5, 1998) (FRL-5740-1)) and a 90-day subchronic inhalation
study (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5)
would help characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.9517.
PMN Number P-97-370
Chemical name: (generic) Propionic acid methyl ester.
CAS number: Not available.
Basis for action: The PMN substance will be used as a solvent. Based on
submitted test data, there is concern for developmental toxicity. EPA
determined that use of the substance as described in the PMN did not
present an unreasonable risk because significant worker exposure would
not result if dermal protection were used by workers and only if the
specific uses stated in the PMN apply. EPA has determined that
manufacture, processing, or use of the substance without dermal
protection, for uses other than stated in the PMN, and domestic
manufacture may result in significant exposure to workers. Based on
this information the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(i).
Recommended testing: None.
CFR citation: 40 CFR 721.8660.
PMN Number P-97-497
Chemical name: Poly(oxy-1,2-ethanediyl), alpha, alpha'- [thiobis(1-oxo-
3,1-propanediyl)] bis[omega-hydroxy-,bis (C11-15 and
C11-15-isoalkyl) ethers.
CAS number: 174254-18-3.
Basis for action: The PMN substance will be used as a spin finish for
industrial polyamide fibers. Based on analogy to nonionic surfactants,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 2 ppb of the PMN substance in surface waters.
EPA determined that use of the substance did not present an
unreasonable risk because significant releases would not occur. EPA has
determined that uses other than those specified in the PMN may result
in significant environmental exposure. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9663.
PMN Numbers P-97-520/521
Chemical names: 2-Piperdinone, 1,3-dimethyl- (P-97-520); 2-piperdinone,
1,5-dimethyl- (P-97-521).
CAS number: 1690-76-2 (P-97-520); 86917-58-0 (P-97-521).
Basis for action: The PMN substances will be used as semiconductor
cleaning solvents. Based on structrual activity analogy to 2-
piperdinone, N-methylpyrrolidone, and other similarly analogous
substances, there is concern for neurotoxicity, developmental toxicity,
and reproductive toxicity. EPA determined that the stated use of the
substances as described in the PMN did not present an unreasonable risk
because significant worker or general population exposure would not
result. EPA has determined that manufacture, processing, or use of the
substances other than for the use stated in the PMN may result in
significant exposure to workers or the general population. 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 oral subchronic
toxicity study in rats (40
[[Page 44567]]
CFR 798.2650 or OPPTS 870.3100 test guideline (63 FR 41845, August 5,
1998) (FRL-5740-1)), a reproduction and fertility effects study in rats
by the oral route (40 CFR 799.9380) (62 FR 43834, August 15, 1997)
(FRL-5719-5), and a prenatal developmental toxicity study by the oral
route in two-species (40 CFR 799.9370) (62 FR 43832, August 15, 1997)
(FRL-5719-5) would help characterize the human health effects of the
PMN substances.
CFR citations: 40 CFR 721.6175 (P-97-520); 40 CFR 721.6176 (P-97-521).
PMN Numbers P-97-552/553
Chemical names: Boric acid (H3BO3), zinc salt
(2=3) (P-97-552); Boric acid (H3BO2), zinc salt
(P-97-553).
CAS number: 10192-46-8 (P-97-552); 14720-55-9 (P-97-553).
Basis for action: The PMN substances will be used as nucleating agents
for no-stick automotive glass coating. Based on structural activity
analogy to zinc and boron compounds, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 3 ppb of the
PMN substances in surface waters. EPA determined that use of the
substances as described in the PMN did not present an unreasonable risk
because the substances would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citations: 40 CFR 721.3031 (P-97-552); 40 CFR 721.3032 (P-97-553).
PMN Numbers P-97-582 and P-97-583
Chemical name: (generic) Substituted heteroaromatic-2 [[4-
(dimethylamino)phenyl] azo]-3-methyl-, salts.
CAS number: Not available.
Basis for action: The PMN substances will be used as textile dyes.
Based on the submitted test data, structural activity analogy to a
similar delocalized cationic dye, the aniline-based azo reduction
product, analogy to Butter Yellow, and analogy to trichlorozincate, EPA
is concerned that the PMN substances may cause developmental toxicity,
carcinogenicity, neurotoxicity, acute and chronic toxicity, severe eye
irritation and corrosivity, blood toxicity, and mutagenicity. EPA
determined that use of the substances as described in the PMN did not
present an unreasonable risk because there were no significant worker
exposures. EPA has determined that domestic manufacture of the PMN
substances may result in significant worker exposures. Based on this
information the PMN substances meet the concern criteria at
Sec. 721.170 (b)(1)(i)(C), (b)(2), (b)(3)(ii), and (b)(3)(iii).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)), an oral two-
species carcinogenicity study (40 CFR 799.9420) (62 FR 43838, August
15, 1997) (FRL-5719-5) and a prenatal developmental toxicity study by
the oral route in two-species (40 CFR 799.9370) (62 FR 43832, August
15, 1997) (FRL-5719-5) would help characterize the health effects of
the PMN substances.
CFR citation: 40 CFR 721.4098.
PMN Number P-97-593
Chemical name: (generic) Hydrofluorochloroalkene.
CAS number: Not available.
Basis for action: The PMN substance will be used as an intermediate.
Based on structural activity analogy to similar substances and toxicity
data submitted with the PMN, EPA is concerned that mutagencity,
neurotoxicity, immunotoxicity, carcinogenicity, liver toxicity, and
kidney toxicity will occur in exposed workers. EPA determined that use
of the substance as an intermediate did not present an unreasonable
risk because it did not result in significant worker exposure. EPA has
determined that use other than an as intermediate 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)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)) and an oral two-
species carcinogenicity study (40 CFR 799.9420) (62 FR 43838, August
15, 1997) (FRL-5719-5) would help characterize the health effects of
the PMN substance.
CFR citation: 40 CFR 721.450.
PMN Number P-97-740
Chemical name: Siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl
Me, di-Me, reaction products with polyethylene-polypropylene glycol Bu
glycidyl ether.
CAS number: 189354-73-2.
Basis for action: The PMN substance will be used as an ingredient for
plastic resins. Based on structural activity analogy to similar
substances, EPA is concerned that lung 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.
EPA has determined that applications generating an aerosol, mist, or
vapor may result in significant worker exposure. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)) would help to
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.9516.
PMN Number P-97-813
Chemical name: (generic) Diphenol tars.
CAS number: Not available.
Basis for action: The PMN substance will be used as a polymer additive.
Based on structural activity analogy to phenols, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 10
ppb of the PMN substance in surface waters. EPA determined that use of
the substance as described in the PMN did not present an unreasonable
risk because the substances would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substance may result in releases to surface waters during use which
exceed the concern concentration. Based on this information the PMN
substance meet the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test
[[Page 44568]]
guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9661.
PMN Number P-97-820
Chemical name: (generic) C.I. Disperse Red 152.
CAS number: Not available.
Basis for action: The PMN substance will be used as a dyestuff for
fabrics. Based on analogy to structurally similar substances, EPA is
concerned that cancer 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.
EPA has determined that 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)(ii).
Recommended testing: EPA has determined that a prenatal developmental
toxicity test by the oral route in two-species (40 CFR 799.9370) (62 FR
43832, August 15, 1997) (FRL-5719-5) and a two-species oral
carcinogenicity study (40 CFR 799.9420) (62 FR 43838, August 15, 1997)
(FRL-5719-5) would help to characterize the health effects of the PMN
substance.
CFR citation: 40 CFR 721.2580.
PMN Numbers P-97-854
Chemical name: (generic) 3,6-Bis(dialkylamino)-9-[2-
alkoxycarbonyl)phenyl]-xanthylium salt,.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant
additive. Based on structural activity analogy to cationic dyes, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 2 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters in significant quantities. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that an activated sludge
sorption isotherm (OPPTS 835.1110 test guideline (63 FR 4259, January
28, 1998) (FRL-5761-7)), an algal acute toxicity study (40 CFR 797.1050
or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)), a chronic 60-day fish early life stage toxicity
test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline
(public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and a 21-day
daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test
guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1))
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.9969.
PMN Numbers P-97-869/870/871
Chemical name: (generic) Alkylated diphenyls.
CAS number: Not available.
Basis for action: The PMN substances will be used as specialty
solvents. Based on structural activity analogy to similar substances,
EPA is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substances in surface waters.
EPA determined that use of the substances as described in the PMNs did
not present an unreasonable risk because the substances would not be
released to surface waters in significant quantities. EPA has
determined that other uses of the substances may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substances meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.2570.
PMN Number P-97-878
Chemical name: (generic) Polysubstituted carbomonocyclic hydroxylamine.
CAS number: Not available.
Basis for action: The PMN substance will be used as an antioxidant.
Based on analogy to structurally similar substances, there is concern
for liver toxicity, kidney toxicity, developmental toxicity, and
neurotoxicity. EPA determined that use of the substance as described in
the PMN did not present an unreasonable risk because significant worker
exposure would not result if respiratory protection were used by
workers. EPA has determined that manufacture, processing, or use of the
substance without respiratory protection may result in significant
inhalation exposure to workers. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)) and a prenatal
developmental toxicity study by the oral route in two-species (40 CFR
799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.2083.
PMN Numbers P-97-880/881/882
Chemical name: (generic) Alkylphenylpolyetheralkanolamines.
CAS number: Not available.
Basis for action: The PMN substances will be used as a fuel additive.
Based on structural activity analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 1 ppb of the PMN substances in surface waters.
EPA determined that use of the substances as described in the PMN did
not present an unreasonable risk because the substances would not be
released to surface waters. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.435.
PMN Numbers P-97-943/944/945/946/947/948
Chemical name: (generic) Mixed trialkylamines.
CAS number: Not available.
Basis for action: The PMN substances will be used as dispersing agents,
[[Page 44569]]
surfactants, and manufacturing intermediates. Based on structural
activity analogy to aliphatic amines, EPA is concerned that toxicity to
aquatic organisms may occur at a concentration as low as 1 ppb of the
PMN substances in surface waters. EPA determined that use of these
substances as described in the PMN did not present an unreasonable risk
because the submitter has agreed to recommend ``no releases to water''
in its Material Safety Data Sheet (MSDS). EPA has determined that other
uses of these substances may result in releases to surface waters which
exceed the concern concentration. Based on this information the PMN
substances meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.9685.
PMN Number P-97-956
Chemical name: (generic) Mixed metal oxide.
CAS number: Not available.
Basis for action: The PMN substance will be used as a pearlescent
pigment. Based on analogy to structurally similar substances, there is
concern for lung toxicity and fibrosis. EPA determined that use of the
substance as described in the PMN did not present an unreasonable risk
because significant worker exposure would not result if respiratory
protection were used by workers. EPA has determined that manufacture,
processing, or use of the substance without respiratory protection may
result in significant inhalation exposure to workers. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-
5719-5) would characterize the human health effects of the PMN
substance.
CFR citation: 40 CFR 721.5548.
PMN Number P-97-1011
Chemical name: Oxirane, 2,2'-[methylenebis [(2,6-dimethyl-4,1-
phenylene) oxymethylene]]bis-.
CAS number: 93705-66-9.
Effective date of section 5(e) consent order: January 15, 1998.
Basis for section 5(e) consent order: The order was issued under
section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding
that the substance may present an unreasonable risk of injury to health
and the environment.
Toxicity concern: Structurally similar chemicals have been shown to
cause cancer and reproductive effects in test animals and toxicity to
aquatic organisms.
Recommended testing: EPA has determined that a 90-day subchronic
inhalation study in rats with attention to pathology of the
reproductive organs (40 CFR 799.9346) (62 FR 43828, August 15,1997)
(FRL-5719-5) and a two-species carcinogenicity study (40 CFR 799.9420)
(62 FR 43838, August 15, 1997) (FRL-5719-5) would help to characterize
health effects. EPA has determined that a fish acute toxicity study (40
CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study
(40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study
(40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. The PMN submitter has
agreed not to exceed the production volume limit without performing the
90-day subchronic inhalation toxicity test.
CFR citation: 40 CFR 721.5580.
PMN Numbers P-97-1028/1029
Chemical name: (generic) Substituted nitrobenzene (P-97-1028);
(generic) Substituted benzonitrile (P-97-1029).
CAS number: Not available.
Basis for action: The PMN substances will be used as described in the
PMNs. Based on analogy to structurally similar substances, there is
concern for mutagenicity, carcinogenicity, immunotoxicity, liver
toxicity, kidney toxicity, reproductive/developmental toxicity, and
neurotoxicity. EPA determined that use of the substances as described
in the PMNs did not present an unreasonable risk because significant
worker exposure would not result if respiratory protection and
impervious gloves were used by workers. EPA has determined that
manufacture, processing, or use of the substances without respiratory
and dermal protection may result in significant inhalation and dermal
exposure to workers. 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 skin sensitization test
in Guinea pigs (40 CFR 798.4100 or OPPTS 870.2600 test guideline (63 FR
41845, August 5, 1998) (FRL-5740-1)), a Salmonella assay (40 CFR
798.5625 or OPPTS 870.5265 test guideline (63 FR 41845, August 5, 1998)
(FRL-5740-1)), a mouse micronucleus assay by intraperitoneal injection
(40 CFR 799.9539) (62 FR 43853, August 15, 1997) (FRL-5719-5), a
neurotoxicity screening battery, National Technical Information Service
(NTIS) Publication 91-154617, March 1991, series 81-8, 82-7, 831
(emphasizes the automated measuring of motor activity which was seen to
be a sensitive end point for several analogues), an Organization for
Economic Cooperation and Development (OECD) guideline no. 421,
reproductive/ developmental toxicity screening test (for initial
information on all aspects of reproductive/developmental toxicity), a
28-day repeated oral exposure test in species to determine liver/kidney
toxicity (40 CFR 798.4900 or OPPTS 870.3700 test guideline (63 FR
41845, August 5, 1998) (FRL-5740-1)), and a two-species carcinogenicity
study (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL- 5719-5)
would help characterize the health effects of the PMN substances.
CFR citations: 40 CFR 721.5360 (P-97-1028); 40 CFR 721.1734 (P-97-
1029).
PMN Number P-97-1046
Chemical name: (generic) Substituted S-phenylthiazole.
CAS number: Not available.
Basis for action: The PMN substance will be used as a pesticide
intermediate. Based on submitted test data for a structurally similar
substance, EPA is concerned that the PMN substance may cause
hepatotoxicity, kidney toxicity, reproductive toxicity, blood toxicity,
developmental toxicity, and toxicity to the spleen and adrenal glands.
Based on structural activity analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 40 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because there were no significant
worker or environmental exposures. EPA has determined that domestic
manufacture of the PMN substance may result in significant
[[Page 44570]]
worker or environmental exposures. Based on this information the PMN
substance meets the concern criteria at Sec. 721.170 (b)(3)(ii) and
(b)(4)(ii).
Recommended testing: EPA has determined that a 90-day subchronic oral
study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (63 FR
41845, August 5, 1998) (FRL-5740-1)), a prenatal developmental toxicity
study by the oral route in two-species (40 CFR 799.9370) (62 FR 43832,
August 15, 1997) (FRL-5719-5), and a reproduction and fertility effects
study by the oral route (40 CFR 799.9380) (62 FR 43834, August 15,
1997) (FRL-5719-5) would help characterize the health effects of the
PMN substance. EPA has also determined that a fish acute toxicity study
(40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study
(40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study
(40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR
16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.5965.
PMN Numbers P-97-1060/1061/1062
Chemical name: (generic) Sodium salts of dodecylphenol.
CAS number: Not available.
Basis for action: The PMN substances will be used as catalysts. Based
on structural activity analogy to phenols, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 1
ppb of the PMN substances in surface waters. EPA determined that use of
the substances as described in the PMNs did not present an unreasonable
risk because the substances would not be released to surface waters in
significant quantities. EPA has determined that other uses of the
substances may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substances
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.2585.
PMN Number P-97-1095
Chemical name: (generic) Substituted alkyl aminomethylene
polyphosphonic acid, salt.
CAS number: Not available.
Basis for action: The PMN substance will be used as a processing aid.
Based on structural activity analogy to aliphatic amines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 200 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.7785.
PMN Number P-98-24
Chemical name: (generic) Methoxy benzoic acid derivative.
CAS number: Not available.
Basis for action: The PMN substance will be used as a mediator in
enzyme catalyzed reactions. Based on submitted test data, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 40 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters in significant quantities. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.1710
PMN Number P-98-45
Chemical name: (generic) Dialkylaminophenyl imino pyrazole acid ester.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant for
thermal printing. Based on structural activity analogy to esters, EPA
is concerned that toxicity to aquatic organisms may occur at a
concentration as low as 30 ppb of the PMN substance in surface waters.
EPA determined that use of the substance as described in the PMN did
not present an unreasonable risk because the substance would not be
released to surface waters. EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Based on this information the PMN substance
meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.987.
PMN Number P-98-91
Chemical name: (generic) Pyrazolone azomethine dye.
CAS number: Not available.
Basis for action: The PMN substance will be used as a colorant for
thermal printing. Based on submitted test data, EPA is concerned that
toxicity to aquatic organisms may occur at a concentration as low as 1
ppb of the PMN substance in surface waters. EPA determined that use of
the substance as described in the PMN did not present an
[[Page 44571]]
unreasonable risk because the substance would not be released to
surface waters. EPA has determined that other uses of the substance may
result in releases to surface waters which exceed the concern
concentration. Based on this information the PMN substance meets the
concern criteria at Sec. 721.170(b)(4)(i).
Recommended testing: EPA has determined that a chronic 60-day fish
early life stage toxicity test in rainbow trout (40 CFR 797.1600 or
OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15,
1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR
797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486,
April 15, 1996) (FRL-5363-1)) would help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.988.
PMN Number P-98-101
Chemical name: 7-Oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl
ester.
CAS number: 41088-52-2.
Basis for action: The PMN substance will be used as a chemical
intermediate. Based on analogy to structurally similar substances and
toxicity data submitted with the PMN, EPA is concerned that
mutagenicity, carcinogenicity, reproductive toxicity in males,
developmental toxicity, irritation to membranes, and sensitization to
lungs and skin will occur in exposed workers. EPA determined that use
of the substance as an intermediate did not present an unreasonable
risk because it did not result in significant worker exposure. EPA has
determined that use other than as an intermediate 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)(3)(i), and (b)(3)(ii).
Recommended testing: EPA has determined that a 90-day oral subchronic
toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)) and an oral two-
species carcinogenicity study (40 CFR 799.9420) (62 FR 43838, August
15, 1997) (FRL-5719-5) would help characterize the health effects of
the PMN substance.
CFR citation: 40 CFR 721.4097.
PMN Number P-98-155
Chemical name: (generic) Disubstituted benzene ether, polymer with
substituted phenol.
CAS number: Not available.
Basis for action: The PMN substance will be used as a reactant in the
manufacture of a thermosetting adhesive polymer. Based on structural
activity analogy to phenols, EPA is concerned that toxicity to aquatic
organisms may occur at a concentration as low as 1 ppb of the PMN
substance in surface waters. EPA determined that use of the substance
as described in the PMN did not present an unreasonable risk because
the substance would not be released to surface waters. EPA has
determined that other uses of the substance may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.1580.
PMN Number P-98-185
Chemical name: Ethanol, 2,2'2''-nitrilotris-, compound with alpha-
[2,4,6-tris(1-phenylethyl)phenyl]-omega-hydroxypoly (oxy-1,2-
ethanediyl)-phosphate.
CAS number: 105362-40-1.
Basis for action: The PMN substance will be used as a pesticide inert.
Based on submitted test data, EPA is concerned that liver toxicity,
effects to the thyroid and pituitary glands, and effects to the kidneys
will occur in exposed workers. EPA determined that import of the
substance for use as a pesticide inert did not present an unreasonable
risk because it did not result in significant worker exposure. EPA has
determined that use other than import for use as a pesticide inert may
result in significant worker exposure. Based on this information the
PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i).
Recommended testing: EPA has determined that a 2-year oral chronic
toxicity study in rats (40 CFR 798.3260 or OPPTS 870.4100 test
guideline (63 FR 41845, August 5, 1998) (FRL-5740-1)) would help
characterize the health effects of the PMN substance.
CFR citation: 40 CFR 721.5356.
PMN Number P-98-198
Chemical name: Phenol, 5-amino-2,4-dicholoro-, hydrochloride.
CAS number: 197178-93-1.
Basis for action: The PMN substance will have a destructive use. Based
on structural activity analogy to phenols and anilines, EPA is
concerned that toxicity to aquatic organisms may occur at a
concentration as low as 2 ppb of the PMN substance in surface waters.
Based on structural activity analogy to halogenated benzenes, phenols,
and anilines EPA is concerned for potential liver toxicity, kidney
toxicity, developmental toxicity, neurotoxicity, carcinogenicity, blood
toxicity, immunotoxicity, and irritation to skin, eyes, and mucous
membranes. EPA determined that use of the substance as described in the
PMN did not present an unreasonable risk because the substance would
not be released to surface waters and workers would not be exposed via
inhalation. EPA has determined that other uses of the substance may
result in releases to surface waters which exceed the concern
concentration and inhalation exposure to workers. Based on this
information the PMN substance meets the concern criteria at
Sec. 721.170(b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substance. EPA has also determined
that a 90-day oral subchronic toxicity study in rats (40 CFR 798.2650
or OPPTS 870.3100 test guideline (63 FR 41845, August 5, 1998) (FRL-
5740-1)), a prenatal developmental toxicity study by the oral route in
two-species (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-
5) and an oral two-species carcinogenicity study (40 CFR 799.9420) (62
FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the
health effects of the PMN substance.
CFR citation: 40 CFR 721.5775.
PMN Numbers P-98-412/414/415/416/417
Chemical names: (generic) Coco alkyldimethyl amine salts.
CAS number: Not available.
[[Page 44572]]
Basis for action: The PMN substances will be used as a component of a
coating. Based on submitted test data, EPA is concerned that toxicity
to aquatic organisms may occur at a concentration as low as 1 ppb of
the PMN substances in surface waters. EPA determined that use of the
substances as described in the PMN did not present an unreasonable risk
because the substances would not be released to surface waters. EPA has
determined that other uses of the substances may result in releases to
surface waters which exceed the concern concentration. Based on this
information the PMN substances meet the concern criteria at
Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that a fish acute toxicity
study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity
study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity
study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft;
61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.9490.
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 12 of the 73
substances, regulation was warranted under section 5(e) of TSCA,
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the substances.
The basis for such findings is outlined in Unit III. of this preamble.
Based on these findings, TSCA section 5(e) consent orders requiring the
use of appropriate exposure controls were negotiated with the PMN
submitters; the SNUR provisions for these substances designated herein
are consistent with the provisions of the TSCA section 5(e) consent
orders.
In the other 61 cases for which the proposed uses are not regulated
under a TSCA section 5(e) consent order, EPA determined that one or
more of the criteria of concern established at 40 CFR 721.170 were met.
EPA is issuing this SNUR for specific chemical substances which
have undergone premanufacture review to ensure that:
(1) EPA will receive notice of any company's intent to manufacture,
import, or process a listed chemical substance for a significant new
use before that activity begins.
(2) EPA will have an opportunity to review and evaluate data
submitted in a SNUR notice before the notice submitter begins
manufacturing, importing, or processing a listed chemical substance for
a significant new use.
(3) When necessary, to prevent unreasonable risks, EPA will be able
to regulate prospective manufacturers, importers, or processors of a
listed chemical substance before a significant new use of that
substance occurs.
(4) All manufacturers, importers, and processors of the same
chemical substance which is subject to a TSCA section 5(e) consent
order are subject to similar requirements.
Issuance of a SNUR for a chemical substance does not signify that
the substance is listed on the TSCA Inventory. Manufacturers,
importers, and processors are responsible for ensuring that a new
chemical substance subject to a final SNUR is listed on the TSCA
Inventory.
V. Direct Final Procedures
EPA is issuing these SNURs as 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 October 19, 1998, unless
EPA receives a written notice by September 21, 1998 that someone wishes
to make adverse or critical comments on EPA's action. If EPA receives
such a notice, EPA will publish a notice to withdraw the direct final
SNUR for the specific substance to which the adverse or critical
comments apply. EPA will then propose a SNUR for the specific substance
providing a 30-day comment period.
This action establishes SNURs for a number of chemical substances.
Any person who submits a notice of intent to submit adverse or critical
comments must identify the substance and the new use to which it
applies. EPA will not withdraw a SNUR for a substance not identified in
a notice.
VI. Test Data and Other Information
EPA recognizes that section 5 of TSCA does not require developing
any particular test data before submission of a SNUN. Persons are
required only to submit test data in their possession or control and to
describe any other data known to or reasonably ascertainable by them.
In cases where a TSCA section 5(e) consent order requires or recommends
certain testing, Unit III. of this preamble lists those recommended
tests.
However, EPA has established production limits in the TSCA section
5(e) consent orders for several of the substances regulated under this
rule, in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the substances. These production limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would permit a reasoned evaluation of the potential risks
posed by these substances. Under recent consent orders, each PMN
submitter is required to submit each study at least 14 weeks (earlier
consent orders required submissions at least 12 weeks) before reaching
the specified production limit. Listings of the tests specified in the
TSCA section 5(e) consent orders are included in Unit III. of this
preamble. The SNURs contain the same production volume limits as the
consent orders. Exceeding these production limits is defined as a
significant new use.
The recommended studies may not be the only means of addressing the
potential risks of the substance. However, SNUNs submitted for
significant new uses without any test data may increase the likelihood
that EPA will take action under TSCA section 5(e), particularly if
satisfactory test results have not been obtained from a prior
submitter. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on:
(1) Human exposure and environmental release that may result from
the significant new use of the chemical substances.
(2) Potential benefits of the substances.
(3) Information on risks posed by the substances compared to risks
posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule some significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2. EPA is required to keep this information
confidential to protect the CBI of the original PMN submitter. EPA
promulgated a procedure to deal with the situation where a specific
significant new use is CBI. This procedure appears in 40 CFR
721.1725(b)(1) and is similar to that in Sec. 721.11 for situations
where the chemical identity of the substance subject to a SNUR is CBI.
This
[[Page 44573]]
procedure is cross-referenced in each of these SNURs.
A manufacturer or importer may request EPA to determine whether a
proposed use would be a significant new use under this rule. Under the
procedure incorporated from Sec. 721.1725(b)(1), a manufacturer or
importer must show that it has a bona fide intent to manufacture or
import the substance and must identify the specific use for which it
intends to manufacture or import the substance. If EPA concludes that
the person has shown a bona fide intent to manufacture or import the
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the substances subject to
these SNURs are also CBI, manufacturers and processors can combine the
bona fide submission under the procedure in Sec. 721.1725(b)(1) with
that under Sec. 721.11 into a single step.
If a manufacturer or importer is told that the production volume
identified in the bona fide submission would not be a significant new
use, i.e. it is below the level that would be a significant new use,
that person can manufacture or import the substance as long as the
aggregate amount does not exceed that identified in the bona fide
submission to EPA. If the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use. EPA is considering
whether to adopt a special procedure for use when CBI production volume
is designated as a significant new use. Under such a procedure, a
person showing a bona fide intent to manufacture or import the
substance, under the procedure described in Sec. 721.11, would
automatically be informed of the production volume that would be a
significant new use. Thus, the person would not have to make multiple
bona fide submissions to EPA for the same substance to remain in
compliance with the SNUR, as could be the case under the procedures in
Sec. 721.1725(b)(1).
VIII. Applicability of Rule to Uses Occurring Before Effective Date
of the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. TSCA section 5(e) consent
orders have been issued for 12 substances and notice submitters are
prohibited by the TSCA section 5(e) consent orders from undertaking
activities which EPA is designating as significant new uses. In cases
where EPA has not received an NOC and the substance has not been added
to the Inventory, no other person may commence such activities without
first submitting a PMN. For substances for which an NOC has not been
submitted at this time, EPA has concluded that the uses are not
ongoing. However, EPA recognizes in cases when chemical substances
identified in this SNUR are added to the Inventory prior to the
effective date of the rule, the substances may be manufactured,
imported, or processed by other persons for a significant new use as
defined in this rule before the effective date of the rule. However, 63
of the 73 substances contained in this rule have CBI chemical
identities, and since EPA has received a limited number of post-PMN
bona fide submissions, the Agency believes that it is highly unlikely
that any of the significant new uses described in the following
regulatory text are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new use as of the
date of publication rather than as of the effective date of the rule.
Thus, persons who begin commercial manufacture, import, or processing
of the substances regulated through this SNUR will have to cease any
such activity before the effective date of this rule. To resume their
activities, these persons would have to comply with all applicable SNUR
notice requirements and wait until the notice review period, including
all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities. If persons who begin commercial manufacture, import, or
processing of the substance between publication and the effective date
of the SNUR do not meet the conditions of advance compliance, they must
cease that activity before the effective date of the rule. To resume
their activities, these persons would have to comply with all
applicable SNUR notice requirements and wait until the notice review
period, including all extensions, expires.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing significant
new use notice requirements for potential manufacturers, importers, and
processors of the chemical substances subject to this rule. EPA's
complete economic analysis is available in the rulemaking record for
this rule (OPPTS-50632).
X. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number OPPTS-50632 (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI is available for inspection
from 12 noon to 4 p.m., Monday through Friday, excluding legal
holidays. The official rulemaking record is located in the TSCA
Nonconfidential Information Center Rm. NE-B607, 401 M St., SW.,
Washington, DC.
Electronic comments can be sent directly to EPA at:
oppt.ncic@epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-50632. Electronic comments on this rule
may be filed online at many Federal Depository Libraries.
The OPPTS harmonized test guidelines referenced in this document
are available on EPA's World Wide Web site (http://www.epa.gov/
epahome/research.htm) under the heading ``Test Methods and Guidelines/
OPPTS Harmonized Test Guidelines.''
XI. Regulatory Assessment Requirements
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), this action is not a
``significant regulatory action'' subject to review by the Office of
Management and Budget (OMB). In addition, this action does not impose
any enforceable duty or contain any unfunded mandate as described in
the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4), or
require prior consultation with State officials as also specified in
Executive Order 12875, entitled Enhancing the Intergovernmental
Partnership (58 FR 58093, October 28, 1993). Nor does it involve
special considerations of
[[Page 44574]]
environmental justice related issues as required by Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994), or additional OMB review in accordance with Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1997).
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9. The information collection requirements
related to this action have already been approved by OMB pursuant to
the PRA under OMB control number 2070-0012 (EPA ICR No. 574). This
action does not impose any burden requiring additional OMB approval.
If an entity were to submit a significant new use notice to the
Agency, the annual burden is estimated to average between 30 and 170
hours per response. This burden estimate includes the time needed to
review instructions, search existing data sources, gather and maintain
the data needed, and complete, review and submit the required
significant new use notice.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
OPPE Regulatory Information Division, Environmental Protection Agency
(Mail Code 2137), 401 M St., SW., Washington, DC 20460, with a copy to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th St., NW., Washington, DC 20503, marked
``Attention: Desk Officer for EPA.'' Please remember to include the OMB
control number in any correspondence, but do not submit any completed
forms to these addresses.
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has previously
certified, as a generic matter, that the promulgation of a SNUR does
not have a significant adverse economic impact on a substantial number
of small entities. The Agency's generic certification for promulgation
of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1) and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
XII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: August 10, 1998.
Ward Penberthy,
Acting 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. 721.305 to subpart E to read as follows:
Sec. 721.305 Di-substituted acetophenone (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as di-
substituted acetophenone (PMN P-97-93) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b)
(concentration set at 1.0 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(2)(i), (g)(2)(v). The following statement shall appear on each
label as specified in Sec. 721.72(b) and the MSDS as specified in
Sec. 721.72(c): This substance is expected to be dermally absorbed and
may cause effects to the liver, kidney, adrenal glands, and the heart.
(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.
3. By adding new Sec. 721.435 to subpart E to read as follows:
Sec. 721.435 Alkylphenylpolyetheralkanolamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkylphenylpolyetheralkanolamines (PMNs P-97-880/881/882) are subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
4. By adding new Sec. 721.450 to subpart E to read as follows:
Sec. 721.450 Hydrofluorochloroalkene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
hydrofluorochloroalkene (PMN P-97-593) is subject to reporting under
this section for the significant new uses
[[Page 44575]]
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
5. By adding new Sec. 721.558 to subpart E to read as follows:
Sec. 721.558 Salt of a fatty alkylamine derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a salt
of a fatty alkylamine derivative (PMN P-96-1426) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
6. By adding new Sec. 721.630 to subpart E to read as follows:
Sec. 721.630 Salt of a modified tallow alkylenediamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a salt
of a modified tallow alkylenediamine (PMN P-96-1425) 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.
7. By adding new Sec. 721.987 to subpart E to read as follows:
Sec. 721.987 Dialkylaminophenyl imino pyrazole acid ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dialkylaminophenyl imino pyrazole acid ester (PMN P-98-45) 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.
8. By adding new Sec. 721.988 to subpart E to read as follows:
Sec. 721.988 Pyrazolone azomethine dye (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
pyrazolone azomethine dye (PMN P-98-91) 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.
9. By adding new Sec. 721.1580 to subpart E to read as follows:
Sec. 721.1580 Disubstituted benzene ether, polymer with substituted
phenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
disubstituted benzene ether, polymer with substituted phenol (PMN P-98-
155) 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.
10. By adding new Sec. 721.1710 to subpart E to read as follows:
Sec. 721.1710 Methoxy benzoic acid derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
methoxy benzoic acid derivative (PMN P-98-24) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 40).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 44576]]
11. By adding new Sec. 721.1734 to subpart E to read as follows:
Sec. 721.1734 Substituted benzonitrile (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted benzonitrile (PMN P-97-1029) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv),
(a)(5)(v), and (a)(6)(v).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
12. By adding new Sec. 721.2078 to subpart E to read as follows:
Sec. 721.2078 1-Piperidinecarboxylic acid, 2-[(dichloro-hydroxy-
carbomonocycle)hydrazono]-, methyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 1-
piperidinecarboxylic acid, 2-[(dichloro-hydroxy-carbomonocycle)
hydrazono]-, methyl ester (PMN P-96-756) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b)
(concentration set at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (l), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (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.
13. By adding new Sec. 721.2079 to subpart E to read as follows:
Sec. 721.2079 Dichloro, hydroxy, hydrazino-carbomonocycle (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dichloro, hydroxy, hydrazino-carbomonocycle (PMN P-96-757) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b)
(concentration set at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (l), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (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.
14. By adding new Sec. 721.2081 to subpart E to read as follows:
Sec. 721.2081 Dichloro, hydroxy, hydrazino-carbomonocycle-
monohydrochloride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
dichloro, hydroxy, hydrazino-carbomonocycle-monohydrochloride (PMN P-
96-758) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(i), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b)
(concentration set at 0.1 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), (g)(1)(iv), (g)(1)(vii), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), and
(g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (g), (l), and (q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (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.
15. By adding new Sec. 721.2083 to subpart E to read as follows:
Sec. 721.2083 Polysubstituted carbomonocyclic hydroxylamine
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(ii), (a)(5)(iv), (a)(5)(v), and (a)(6)(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. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (d) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
16. By adding new Sec. 721.2480 to subpart E to read as follows:
[[Page 44577]]
Sec. 721.2480 Isoalkyldimethylamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isoalkyldimethylamine (PMN P-96-1320) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
17. By adding new Sec. 721.2485 to subpart E to read as follows:
Sec. 721.2485 1,3-Dioxolane, 2-ethenyl-.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-Dioxolane, 2-
ethenyl- (PMN P-96-1006; CAS No. 3984-22-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3)(i), (a)(4),
(a)(5)(iii), (a)(5)(xii), (a)(5)(xiii), (a)(5)(xiv), (a)(6)(v), (b)
(concentration set at 1.0 percent), and (c). The imperviousness of each
item pursuant to (a)(2)(i) and (a)(2)(ii) must be demonstrated by
actual testing under (a)(3)(i) and not by manufacturer specifications.
Permeation testing shall be conducted according to the ASTM F739
``Standard Test Method for Resistance of Protective Clothing Materials
to Permeation by Liquids or Gases.'' Results shall be recorded as a
cumulative permeation rate as a function of time, and shall be
documented in accordance with ASTM F739 using the format specified in
ASTM F1194-89 ``Guide for Documenting the Results of Chemical
Permeation Testing on Protective Clothing Materials.'' Gloves may not
be used for a time period longer than they are actually tested and must
be replaced at the end of each work shift. The manufacturer, importer,
or processor must submit all test data to the Agency and must receive
written Agency approval for each type of glove tested prior to use of
such gloves.
(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)(iii), (g)(1)(iv), (g)(2)(ii), (g)(2)(iii), and (g)(5). The
following statements shall appear on each label as specified in
Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): This
substance may cause fatality. When using this substance avoid dermal
contact. When using this substance use respiratory protection or
engineering and process controls to mitigate respiratory exposure. When
using this substance use dermal protection to prevent dermal exposure.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), and (h) are applicable
to manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
18. By adding new Sec. 721.2532 to subpart E to read as follows:
Sec. 721.2532 Substituted diphenylmethane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted diphenylmethane (PMN P-97-4) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of 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. 721.2570 to subpart E to read as follows:
Sec. 721.2570 Alkylated diphenyls (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
alkylated diphenyls (PMNs P-97-869/870/871) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
20. By adding new Sec. 721.2580 to subpart E to read as follows:
Sec. 721.2580 C.I. Disperse Red 152 (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as C.I.
disperse red 152 (PMN P-97-820) 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 specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
21. By adding new Sec. 721.2585 to subpart E to read as follows:
Sec. 721.2585 Sodium salts of dodecylphenol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as sodium
salts of dodecylphenol (PMNs P-97-1060/1061/1062) are subject to
reporting under this
[[Page 44578]]
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
22. By adding new Sec. 721.3031 to subpart E to read as follows:
Sec. 721.3031 Boric acid (H3BO3), zinc salt
(2=3).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as boric acid
(H3BO3), zinc salt (2=3) (PMN P-97-552; CAS No.
10192-46-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
23. By adding new Sec. 721.3032 to subpart E to read as follows:
Sec. 721.3032 Boric acid (H3BO2), zinc salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as boric acid
(H3BO2), zinc salt (PMN P-97-553; CAS No. 14720-
55-9) are subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 3).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
24. By adding new Sec. 721.3635 to subpart E to read as follows:
Sec. 721.3635 Octadecanoic acid, ester with 1,2-propanediol,
phosphate, anhydride with silicic acid (H4SiO4).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as octadecanoic acid,
ester with 1,2-propanediol, phosphate, anhydride with silicic acid
(H4SiO4) (PMN P-96-1520; CAS No. 177771-31-2) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(i), and (g)(5).
The following statement shall appear on each label as specified in
Sec. 721.72(b) and the MSDS as specified in Sec. 721.72(c): Do not
release into the environment in quantities that allow surface water
concentrations to exceed 6 ppb.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(p) (15 months).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 6).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (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.
25. By adding new Sec. 721.4097 to subpart E to read as follows:
Sec. 721.4097 7-Oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl
ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 7-
oxabicyclo[4.1.0]heptane-3-carboxylic acid, methyl ester (PMN P-98-101)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c) and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
26. By adding new Sec. 721.4098 to subpart E to read as follows:
Sec. 721.4098 Substituted heteroaromatic-2[[4-(dimethylamino)
phenyl]azo]-3-methyl-, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
substituted heteroaromatic-2[[4-(dimethylamino)phenyl]azo]-3-methyl-,
salts (PMNs P-97-582 and P-97-583) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (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.
27. By adding new Sec. 721.5290 to subpart E to read as follows:
Sec. 721.5290 Phenylazoalkoxy naphthylamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
phenylazoalkoxy napthylamines (PMNs P-97-42 and P-97-43) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
[[Page 44579]]
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 50 for P-97-42) (N = 40 for P-97-43).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
28. By adding new Sec. 721.5356 to subpart E to read as follows:
Sec. 721.5356 Ethanol, 2,2'2''-nitrilotris-, compound with alpha-
2,4,6-tris (1-phenylethyl)phenyl]-omega-hydroxypoly (oxy-1,2-
ethanediyl) phosphate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanol, 2,2'2''-
nitrilotris-, compound with alpha-[2,4,6-tris(1-phenylethyl)phenyl]-
omega-hydroxypoly (oxy-1,2-ethanediyl) phosphate (PMN P-98-185) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j) (pesticide inert).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (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. 721.5360 to subpart E to read as follows:
Sec. 721.5360 Substituted nitrobenezene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted nitrobenezene (PMN P-97-1028) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(2)(i), (a)(3), (a)(4), (a)(5)(ii), (a)(5)(iv),
(a)(5)(v), and (a)(6)(v).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
30. By adding new Sec. 721.5548 to subpart E to read as follows:
Sec. 721.5548 Mixed metal oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a mixed
metal oxide (PMN P-97-956) 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), and (a)(6)(i).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (d) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
31. By adding new Sec. 721.5580 to subpart E to read as follows:
Sec. 721.5580 Oxirane, 2,2'-[methylenebis[(2,6-dimethyl-4,1-
phenylene)oxymethylene]]bis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2,2'-
[methylenebis[(2,6-dimethyl-4,1-phenylene)oxymethylene]]bis- (PMN P-97-
1011; CAS No. 93705-66-9) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi),
(a)(5)(vii), (a)(6)(i), (a)(6)(ii), (a)(6)(iv), (b) (concentration set
at 0.1 percent), and (c). As an alternative to the respiratory
requirements listed here, a manufacturer, importer, or processor may
choose to follow the new chemical exposure limit (NCEL) provisions
listed in the TSCA section 5(e) consent order for this substance. The
NCEL is 0.35 milligram/meter3 (mg/m3).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set 0.1 percent),
(f), (g)(1)(vi), (g)(1)(vii), (g)(2)(ii), (g)(2)(iv), (g)(3)(i),
(g)(3)(ii), (g)(4)(i), (g)(4)(iii), and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (q).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (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.
32. By adding new Sec. 721.5775 to subpart E to read as follows:
Sec. 721.5775 Phenol, 5-amino-2,4-dicholoro-, hydrochloride.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, 5-amino-
2,4-dicholoro-, hydrochloride (PMN P-98-198) 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)(i), (w)(i), and (x)(i).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125
[[Page 44580]]
(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.
33. By adding new Sec. 721.5965 to subpart E to read as follows:
Sec. 721.5965 Substituted S-phenylthiazole (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted s-phenylthiazole (PMN P-97-1046) 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.
34. By adding new Sec. 721.6175 to subpart E to read as follows:
Sec. 721.6175 2-Piperdinone, 1,3-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-Piperdinone, 1,3-
dimethyl- (PMN P-97-520; CAS No. 1690-76-2) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.80(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. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
35. By adding new Sec. 721.6176 to subpart E to read as follows:
Sec. 721.6176 2-Piperdinone, 1,5-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified as 2-Piperdinone,
1,5-dimethyl- (PMN P-97-521; CAS No. 86917-58-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.80(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. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
36. By adding new Sec. 721.6498 to subpart E to read as follows:
Sec. 721.6498 Modified polyisocyanates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified polyisocyanates (PMN P-96-1428) 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)(viii),
(a)(5)(ix), (a)(6)(ii), (b) (concentration set at 0.1 percent), and
(c). As an alternative to the respiratory requirements listed here, a
manufacturer, importer, or processor may choose to follow the NCEL
provisions listed in the TSCA section 5(e) consent order for this
substance. The NCEL is 0.05 mg/m3.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1 percent),
(f), and (g)(5). The following statements shall appear on each label as
specified in Sec. 721.72(b) and the MSDS as specified in
Sec. 721.72(c): Warnings. Exposure to diisocyanates may cause the
following human health effects: Skin irritation and allergic reactions,
respiratory irritation, respiratory sensitization, and lung toxicity;
some diisocyanates also may cause cancer. The likelihood that these
effects will occur depends on a number of factors; among them, the
level of exposure, frequency of exposure, part of the body exposed, and
sensitivity of the exposed individual. Symptoms of allergic reaction
and respiratory sensitization include rashes, cough, shortness of
breath, asthma, chest tightness and other breathing difficulties. There
is uncertainty as to the mechanism by which sensitization occurs. In
sensitized individuals, exposure to even small amounts of diisocyanates
(below government-recommended workplace exposure levels) may cause
allergic respiratory reactions like asthma and severe breathing
difficulties. It is especially important to note that contact with skin
may lead to respiratory sensitization or cause other allergic
reactions. In some cases, the effects of diisocyanate exposure may be
immediate and life-threatening; in others, the effects may be delayed
and occur hours after the exposure has ended. Repeated or prolonged
exposure to diisocyanates may also cause irritation to eyes, skin,
respiratory tract and lungs, as well as adverse chronic lung effects,
like decreased lung capacity and function. Individuals experiencing
shortness of breath, tightness in the chest or other problems breathing
should seek immediate medical attention. When using this substance the
following protective measures should be used: In workplaces where
individuals handle diisocyanates or coatings or other formulations that
contain them, an industrial hygiene and safety program should be
operative. Important components of this program include: Hazard
communication and training on safe handling practices; use of efficient
and well-maintained application equipment, engineering controls and
personal protective equipment; housekeeping procedures including spill
prevention and cleanup practices; and, if feasible, means to measure
airborne levels of polyisocyanates and diisocyanates. During spray
applications, workers should take precautions to avoid breathing
vapors, mists or aerosols. Inhalation exposures should be limited to < 0.05="">3 as an 8-hour time-weighted average (TWA) for
combined polyisocyanates and diisocyanates. Engineering controls should
serve as the first, most effective means of reducing airborne
polyisocyanate and diisocyanate concentrations; an appropriate National
Institute for Occupational Safety and Health/Mine Safety and Health
Administration (NIOSH/MSHA) approved respirator should be used as a
secondary tool to lower exposures. Currently, downdraft spray booths
and high-volume low-pressure (HVLP) spray guns appear to offer the most
efficient
[[Page 44581]]
technology to reduce inhalation exposures; a maintenance program should
always be used to ensure optimal operating efficiencies. To limit
dermal contact, individuals should wear impermeable gloves, protective
clothing and goggles or glasses with side shields.
(iii) Industrial, commercial, and consumer activites. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
37. By adding new Sec. 721.7285 to subpart E to read as follows:
Sec. 721.7285 Amines, N-cocoalkyltrimethylenedi-, citrates.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified as amines, N-
cocoalkyltrimethylenedi-, citrates. (PMN P-93-880; CAS No. 189120-63-6)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and
(g)(5).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (f), (g), (h), 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.
38. By adding new Sec. 721.7286 to subpart E to read as follows:
Sec. 721.7286 Amines, N-tallowalkyltripropylenetetra-, citrates.
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substance identified as amines, N-
tallowalkyltripropylenetetra-, citrates (PMN P-93-881; CAS No. 189120-
62-5) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(ii), (g)(4)(iii), and
(g)(5).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (f), (g), (h), 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.
39. By adding new Sec. 721.7785 to subpart E to read as follows:
Sec. 721.7785 Substituted alkyl aminomethylene polyphosphonic acid,
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
substituted alkylamino methylene polyphosphonic acid, salt (PMN P-97-
1095) 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.
40. By adding new Sec. 721.8153 to subpart E to read as follows:
Sec. 721.8153 Di-substituted propanedione (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as di-
substituted propanedione (PMN P-97-94) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(2)(iii), (a)(3), (b)
(concentration set at 1.0 percent), and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent),
(f), (g)(2)(i), (g)(2)(v). The following statement shall appear on each
label as specified in Sec. 721.72(b) and the MSDS as specified in
Sec. 721.72(c): This substance is expected to be dermally absorbed and
may cause effects to the liver, kidney, adrenal glands, and the heart.
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are
applicable to manufacturers, importers, and processors of this
substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
41. By adding new Sec. 721.8660 to subpart E to read as follows:
Sec. 721.8660 Propionic acid methyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
propionic acid methyl ester (PMN P-97-370) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63 (a)(1), (a)(2)(i), and (a)(3).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), (d), (e), and (i) are applicable to
[[Page 44582]]
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
42. By adding new Sec. 721.9490 to subpart E to read as follows:
Sec. 721.9490 Coco alklydimethyl amine salts (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as coco
alkyldimethyl amine salts (PMNs P-98-412/414/415/416/417) are subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
43. By adding new Sec. 721.9516 to subpart E to read as follows:
Sec. 721.9516 Siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl
Me, di-Me, reaction products with polyethylene-polypropylene glycol Bu
glycidal ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
siloxanes and silicones, 3-[(2-aminoethyl) amino]propyl Me, di-Me,
reaction products with polyethylene-polypropylene glycol Bu glycidyl
ether (PMN P-97-740; CAS No. 189354-73-2) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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 specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
44. By adding new Sec. 721.9517 to subpart E to read as follows:
Sec. 721.9517 Siloxanes and silicones, de-Me, 3-[4-[[[3-(dimethyl
amino) propyl] amino]carbonyl]-2-oxo-1-pyrrolidinyl] propyl Me.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as siloxanes and
silicones, de-Me, 3-[4-[[[3-(dimethylamino) propyl]amino] carbonyl]-2-
oxo-1-pyrrolidinyl]propyl Me (PMN P-97-332) 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.
45. By adding new Sec. 721.9595 to subpart E to read as follows:
Sec. 721.9595 Alkyl benzene sulfonic acids and alkyl sulfates, amine
salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as alkyl
benzene sulfonic acids and alkyl sulfates, amine salts (PMNs P-97-296/
297/298/299) are subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
46. By adding new Sec. 721.9661 to subpart E to read as follows:
Sec. 721.9661 Diphenol tars (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
diphenol tars (PMN P-97-813) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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 (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.
47. By adding new Sec. 721.9663 to subpart E to read as follows:
Sec. 721.9663 Poly(oxy-1,2-ethanediyl), alpha, alpha'-[thiobis (1-
oxo-3,1-propanediyl)]bis [omega-hydroxy-,bis (C11-15 and
C11-15-isoalkyl) ethers.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as poly(oxy-1,2-
ethanediyl), alpha, alpha'-[thiobis (1-oxo-3,1-propanediyl)]bis [omega-
hydroxy-,bis(C11-15 and C11-15-isoalkyl) ethers
(PMN P-97-497; CAS No. 174254-18-3) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(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. The recordkeeping requirements specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 44583]]
48. By adding new Sec. 721.9685 to subpart E to read as follows:
Sec. 721.9685 Mixed trialkylamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as mixed
trialkylamines (PMNs P-97-943/944/945/946/947/948) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
49. By adding new Sec. 721.9719 to subpart E to read as follows:
Sec. 721.9719 Tris carbamoyl triazine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as tris
carbamoyl triazine (PMN P-95-1098) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(3)(i), (g)(3)(ii), (g)(4)(i),
and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 40).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), (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.
50. By adding new Sec. 721.9969 to subpart E to read as follows:
Sec. 721.9969 3,6-Bis(dialkylamino) -9-[2-alkoxycarbonyl) phenyl]-
xanthylium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 3,6-
bis(dialkylamino) -9-[2-alkoxycarbonyl) phenyl]-xanthylium salt (PMN P-
97-854) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (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.
51. By adding new Sec. 721.9973 to subpart E to read as follows:
Sec. 721.9973 Zirconium dichlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
zirconium dichlorides (PMNs P-97-179/181/189/769/775/781/782/783) are
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N = 20).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 98-22441 Filed 8-19-98; 8:45 am]
BILLING CODE 6560-50-F
