[Federal Register Volume 62, Number 105 (Monday, June 2, 1997)]
[Proposed Rules]
[Pages 29684-29688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14297]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50626, etc.; FRL-5597-1]
Proposed Modification of Significant New Use Rules For Certain
Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to modify significant new use rules (SNURs)
for six substances promulgated under section 5(a)(2) of the Toxic
Substances Control Act (TSCA) for certain chemical substances based on
new data. Based on the data the Agency determined that the SNURs should
be modified.
DATES: Written comments must be received by July 2, 1997.
ADDRESSES: Each comment must bear the appropriate docket control number
OPPTS-50626, etc. All comments should be sent in triplicate to: OPPT
Document Control Officer (7407), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 401 M Street, SW., Room G-099,
East Tower, Washington, DC 20460.
Comments and data may also be submitted electronically by following
the instructions under Unit III of this preamble. No confidential
business information (CBI) should be submitted through e-mail.
All comments which are claimed confidential must be clearly marked
as such. Three additional sanitized copies
[[Page 29685]]
of any comments containing CBI must also be submitted. Nonconfidential
versions of comments on this rule will be placed in the rulemaking
record and will be available for public inspection. Unit IV of this
preamble contains additional information on submitting comments
containing CBI.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401
M St., SW., Washington, DC 20460; telephone: (202) 554-1404; TDD: (202)
554-0551; e-mail: TSCA-Hotline@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register referenced for each
substance, OPPTS-50577, June 26, 1990 (55 FR 26110); OPPTS-50588,
November 6, 1990 (55 FR 46774); OPPTS-50592, August 13, 1991 (56 FR
40212); OPPTS-50601, September 23, 1992 (57 FR 44070); and OPPTS-50622,
March 1, 1995 (60 FR 11042) (FRL-4868-4); EPA issued a SNUR
establishing significant new uses for the substances listed in Unit I
of this preamble. Because of additional data EPA has received for these
substances, EPA is proposing to modify the SNURs.
I. Proposed Modifications
EPA is proposing to modify the 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 the substances, including its premanufacture notice
(PMN) number, chemical name (generic name if the specific name is
claimed as CBI), CAS number (if assigned), the proposed modification
and basis, Federal Register reference, docket number, and the CFR
citation in the regulatory text section of this proposed rule. Further
background information for the substances is contained in the
rulemaking record referenced in Unit III of this preamble.
PMN Number P-89-31
Chemical name: 2-propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl
ester.
CAS number: Not available.
Federal Register publication date and reference: November 6, 1990 (55
FR 46774).
Docket number: OPPTS-50588.
Basis for modification of SNUR: EPA received a second PMN for this
substance. Based on analogy to acrylates and epoxides, EPA is concerned
that toxicity to aquatic organisms may occur at a concentration as low
as 80 parts per billion (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. Based on the
information in the PMN, EPA has determined that other uses of the
substance may result in releases to surface waters which exceed the
concern concentration. Therefore, EPA has decided that a modification
to the SNUR, requiring notification if the substance is released to
water was necessary to prevent significant changes in environmental
exposure. Based on this information the PMN substance meets the concern
criteria at Sec. 721.170(b)(4)(ii).
CFR number: 40 CFR 721.8350.
PMN Number P-91-43
Chemical name: (generic) Fluorene substituted aromatic amine.
CAS number: Not available.
Federal Register publication date and reference: September 23, 1992 (57
FR 44065). Amended on June 6, 1994 (59 FR 29204).
Docket number: Docket Number: OPPTS-50601.
Basis for modification of SNUR: The original PMN submitter submitted a
90-day subchronic study on the PMN substance according to the terms of
the section 5(e) consent order for the substance between EPA and the
PMN submitter. The test results demonstrated liver effects at 50 and
500 mg/kg/day dose levels and blood effects at the 500 mg/kg/day dose
level. No adverse effects were seen at the lowest dose level of 5 mg/
kg/day. Based on the test results, EPA set a No Observed Adverse Effect
Level (NOAEL) at 5/mg/kg/day. The PMN submitter requested that EPA
revoke the consent order for the substance based on the 90-day study
and mutagencity data it had developed and submitted for a similar
substance, P-88-998. The mutagencity test results were negative in the
Ames assay, negative in a mitotic recombination assay (S. Cerevisiae),
weakly mutagenic in a mouse lymphoma assay, negative in a mouse
micronucleus assay (intraperitoneal route), and was not a chromosome
mutagen in human peripheral blood lymphocyte cells in culture during a
human lymphocyte study. EPA chose to modify the order based on
continued concerns for environmental effects from potential water
releases and liver effects to unprotected workers. The modification
eliminates hazard communication requirements for cancer and
reproductive toxicity, requires less stringent respiratory protection,
and eliminates triggered toxicity testing. The proposed modification of
this SNUR is consistent with the modification to the consent order.
CFR number: 40 CFR 721.3764.
PMN Number P-85-1331
Chemical name: Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl).
CAS number: Not available.
Federal Register publication date and reference: June 26, 1990 (55 FR
26110).
Docket number: OPPTS-50577.
Basis for modification of SNUR: A significant new use notice (SNUN) was
submitted for this substance describing limited but measurable releases
to water of the substance. After review of the SNUN, EPA determined
that releases to water of less than 1 part per billion (ppb) would
result in no significant environmental exposures. The Agency has
determined, therefore, that modifying the SNUR by allowing releases to
water of less than 1 ppb will not result in significant changes in
environmental exposure.
CFR number: 40 CFR 721.5225.
PMN Number P-91-598
Chemical name: (generic) Epoxidized copolymer of phenol and substituted
phenol.
CAS number: Not available.
Federal Register publication date and reference: September 23, 1992 (57
FR 44071).
Docket number: OPPTS-50601.
Basis for modification of SNUR: A SNUN was submitted for this substance
detailing its use as a densified tablet formulation of an epoxy molding
compound. After review of the SNUN, EPA determined that use of the
substance as a densified tablet formulation of an epoxy molding
compound would result in no significant dermal or inhalation exposures.
The Agency has determined, therefore, that modifying the SNUR by
allowing use as a densified tablet formulation of an epoxy molding
compound will not result in significant changes in human exposure.
CFR number: 40 CFR 721.7210.
PMN Number P-93-955
Chemical name: (generic) Formaldehyde, polymer with substituted
phenols, glycidyl ether.
CAS number: Not available.
Federal Register publication date and reference: August 30, 1995 (60 FR
45084).
Docket number: OPPTS-50622.
Basis for modification of SNUR: A SNUN was submitted for a similar
substance (40 CFR 721.7210) detailing its use as a densified tablet
formulation of an epoxy molding compound. The
[[Page 29686]]
SNUN submitter petitioned the Agency to modify the SNUR for this
substance based on the data in that SNUN. After review of the SNUN and
the SNUR for this substance, EPA determined that use of the substance
as a densified tablet formulation of an epoxy molding compound would
result in no significant dermal or inhalation exposures. The Agency has
determined, therefore, that modifying the SNUR allowing use as a
densified tablet formulation of an epoxy molding compound will not
result in significant changes in human exposure.
CFR number: 40 CFR 721.7046.
PMN Number P-90-226
Chemical name: (generic) Titanate [Ti6013 (2-)] dipotassium.
CAS number: Not available.
Federal Register publication date and reference: August 13, 1991 (56 FR
40215).
Docket number: OPPTS-50592.
Basis for modification of SNUR: A SNUN was submitted for the substance
detailing an additional manufacturing process. In addition a 90-day
subchronic inhalation study was submitted by the PMN submitter under
the terms of the section 5(e) consent order. The study demonstrated no
evidence of fibrosis to test animals. After review of the SNUN, EPA
determined that the substance produced by that manufacturing process
contained some fibers that are indicated in the development of
fibrosis, but concluded that such levels would be unlikely to result in
significant inhalation risk from exposure. After review of the test
data, EPA determined that use of the substance without requiring hazard
communication or a production volume trigger as described in the
consent order and SNUR would result in no significant inhalation
exposures. The Agency has determined, therefore, that modifying the
SNUR allowing the manufacturing process described in the SNUN and
removing the hazard communication and production volume limit
requirements will not result in significant changes in human exposure.
CFR number: 40 CFR 721.9675.
II. Rationale for Modification of the Rules
During review of the PMNs submitted for the chemical substances
that are the subject of these modifications, EPA concluded that
regulation was warranted based on the fact that activities not
described in the section 5(e) consent order or the PMN may result in
significant changes in human or environmental exposure. The basis for
such findings is in the rulemaking records referenced in Unit III of
this preamble. Based on these findings, a section 5(e) consent order
was negotiated with the PMN submitter and/or a SNUR was promulgated.
In light of the modification to a consent order, the data submitted
in a PMN, or the data submitted in a SNUN, the Agency has determined
that modifying these SNURs would not result in significant changes in
human or environmental exposure. The modification of SNUR provisions
for these substances designated herein is consistent with the
provisions of the section 5(e) order or data submitted in the PMN/SNUN.
III. Rulemaking Record
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket number
OPPTS-50626, etc. (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 confidential business information (CBI), is
available for inspection from 12 noon to 4 p.m., Monday through Friday,
excluding legal holidays. The official rulemaking record is located in
the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St.
SW., Washington, DC.
Electronic comments can be sent directly to EPA at:
oppt-ncic@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number OPPTS-50626, etc. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries.
IV. Comments Containing Confidential Business Information
Any person who submits comments claimed as CBI must mark the
comments as ``confidential,'' ``trade secret,'' or other appropriate
designation. Comments not claimed as confidential at the time of
submission will be placed in the public file. Any comments marked as
confidential must prepare and submit a public version of the comments
that EPA can place in the public file.
V. Regulatory Assessment
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' subject to review by
the Office of Management and Budget (OMB). In addition, this action
does not impose any enforceable duty or contain any unfunded mandate as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4),
or require prior consultation with State officials as specified by
Executive Order 12875 (58 FR 58093, October 28, 1993), or involve
special considerations of environmental justice related issues as
required by Executive Order 12898 (59 FR 7629, February 16, 1994).
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that any
promulgation of a SNUR, including this rule, will not have a
significant adverse economic impact on a substantial number of small
entities. Because this certification is applicable to all SNURs, it
will also serve as the generic certification for the promulgation of
any SNUR and EPA will incorporate it by reference in future individual
SNUR actions. In addition, this certification and rationale presented
below will be provided to the Chief Counsel for Advocacy of the Small
Business Administration.
The certification presented above is based on the following
rationale. A SNUR applies to any person (including small or large
entities) who intends to engage in any activity described in the rule
as a ``significant new use.'' By definition of the word ``new,'' and
based on all information currently available to EPA, it appears that no
small or large entities presently engage in such activity. Since a SNUR
only requires that any person who intends to engage in such activity in
the future must first notify EPA (by submitting a Significant New Use
Notice (SNUN)), no economic impact will even occur until someone
decides to engage in those activities. Although some small entities may
decide to conduct such activities in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of over 530 SNURs, the
Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none
appear to be from small entities. In fact, EPA expects to receive few,
if any, SNUNs from either large or small entities in response to any
SNUR. Therefore, EPA believes that, the economic impact of complying
with a SNUR is not expected to be
[[Page 29687]]
significant or adversely impact a substantial number of small entities.
An agency may not conduct or sponsor, and a person is not required
to respond to, an information collection request unless it displays a
currently valid OMB control number. The information collection
requirements related to this action have already been approved by OMB
pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.,
under OMB control number 2070-0012 (EPA ICR No. 574). This action does
not impose any burdens requiring additional OMB approval. The public
reporting burden for this collection of information is estimated to
average 100 hours per response. The burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete and review the collection of
information.
VI. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House ofRepresentatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a major rule as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials,
Recordkeeping and reporting requirements.
Dated: May 20, 1997.
William H. Sanders, III
Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By revising Sec. 721.3764 to read as follows:
Sec. 721.3764 Fluorene substituted aromatic amine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as a
fluorene substituted aromatic amine (PMN P-91-43) 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)(iii), (a)(3), (a)(4), (a)(5)(iii),
(a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at
1.0 percent) and (c). However, these requirements do not apply after
the PMN substance is adhered onto film or incorporated into prepreg
form (resin impregnated substrate).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 during manufacture (a), (b), (c), (d), (e) (concentration
set at 1.0 percent), (f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii),
(g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii)
and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(l).
(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) through (i) and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
3. In Sec. 721.5225 by revising paragraph (a)(2)(v) to read as
follows:
Sec. 721.5225 Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl) (specific
name).
(a) Chemical substance and significant new uses subject to
reporting. * * *
(2) * * *
(v) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where n = 1).
* * * * *
4. In Sec. 721.7046 by revising paragraph (a)(1) to read as
follows:
Sec. 721.7046 Formaldehyde, polymer with substituted phenols, glycidyl
ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
polymer with substituted phenols, glycidyl ether (PMN P-93-955) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section. The requirements of this
section do not apply once the substance is a component of a highly
densified tablet formulation of an epoxy molding compound.
* * * * *
5. In Sec. 721.7210 by revising paragraph (a)(1) to read as
follows:
Sec. 721.7210 Epoxidized copolymer of phenol and substituted phenol.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as epoxidized
copolymer of phenol and substituted phenol (PMN P-91-598) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section. The requirements of this section do
not apply once the substance is a component of a highly densified
tablet formulation of an epoxy molding compound.
* * * * *
6. In Sec. 721.8350 by adding paragraph (a)(2)(iv) to read as
follows:
Sec. 721.8350 2-Propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl
ester .
(a) Chemical substance and significant new uses subject to
reporting. * * *
(2) * * *
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
* * * * *
7. In Sec. 721.9675 by removing and reserving paragraph (a)(2)(i)
and revising paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A),
and (b)(1) to read as follows:
Sec. 721.9675 Titanate [Ti6013 (2-)] dipotassium.
(a) Chemical substance and significant new uses subject to
reporting. * * *
(2) * * *
(i) [Reserved]
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (l). In addition, a significant new
use of the substance is importation of the PMN substance if:
(A) Manufactured by other than the method described in
premanufacture notice P-90-226 or significant new use notice P-96-1408.
If manufactured by the method described in significant new use notice
P-96-1408 then notification requirements for the bulk density
measurements in paragraph (a)(2)(i)(B) of this section do not apply.
* * * * *
(b) Specific requirements. * * *
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125 (a), (b), (c), and (i) are applicable to
[[Page 29688]]
manufacturers, importers, and processors of this substance. In
addition, records shall be kept identifying the foreign supplier and
documenting, by lot, for each shipment, the method of manufacture and
bulk density measurements. Records of bulk density measurements are
required only when notification requirements are applicable.
* * * * *
[FR Doc. 97-14297 Filed 5-30-97; 8:45 am]
BILLING CODE 6560-50-F
