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TSCA SNURs for var. alkyl phenols: they're used from a->z!
in addition to these alkyl phenyls, a few other alkyl phenols, alkyl
benzens & similar new uses were approved in this notice. All are ring
shaped (one or two) molecules w/ a carbon chain attached (alkylated), such
as the alkyl phenols used as surfactants and some are strong hormome
disruptors, at least based on their effects on auatic life.
---
[Federal Register: August 20, 1998 (Volume 63, Number 161)]
[Rules and Regulations]
[Page 44562-44583]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au98-10]
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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
[SNIP]
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.
[snip]
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.
[snip]
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.
[snip]
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.
[snip]
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.
[snip]
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.
[SNIP]
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.
[snip]
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.
[snip]
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.
[snip]
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:
[snip]
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.
[snip]
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.