[Federal Register Volume 60, Number 103 (Tuesday, May 30, 1995)]
[Proposed Rules]
[Pages 28075-28077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13135]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50582L; FRL-4919-6]
RIN 2070-AB27
1,3-Propanediamine, N,N"-1,2-Ethanediylbis-, Polymer with 2,4,6-
Trichloro-1,3,5-triazine, Reaction Products with N-butyl-2,2,6,6-
tetramethyl-4-piperidinamine; Proposed Modification of Significant New
Use Rules
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to modify the significant new use rules
(SNUR) promulgated under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 1,3-propanediamine, N,N"-1,2-ethanediylbis-,
polymer with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-
butyl-2,2,6,6-tetramethyl-4-piperidinamine, based on a modification to
the TSCA 5(e) consent order regulating the substance.
DATES: Written comments must be received by EPA on or before June 29,
1995.
ADDRESSES: All comments must be sent in triplicate to: TSCA Document
Receipt Office (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-G99, 401 M St., SW., Washington,
DC 20460. Comments that are confidential must be clearly marked
confidential business information (CBI). If CBI is claimed, three
additional sanitized copies must also be submitted. Nonconfidential
versions of comments on this proposed rule will be placed in the
rulemaking record and will be available for public inspection. Comments
should include the docket control number. The docket control number for
the chemical substance in this SNUR is Unit IV. of this preamble
contains additional information on submitting comments containing CBI.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic comments
must be submitted as an ASCII file avoiding the use of special
[[Page 28076]] characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect in 5.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket number OPPTS-50582L. No CBI should be
submitted through e-mail. Electronic comments on this proposed rule may
be filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found in Unit III. of this
document.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, TSCA
Assistance Office (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-543B, 401 M St., SW.,
Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 20, 1990
(55 FR 33296), EPA issued a SNUR establishing significant new uses for
1,3-propanediamine, N,N"-1,2-ethanediylbis-, polymer with 2,4,6-
trichloro-1,3,5-triazine, reaction products with N-butyl-2,2,6,6-
tetramethyl-4-piperidinamine based on the section 5(e) consent order
for the substance. Because of additional data EPA has received for this
substance, EPA is proposing to modify the SNUR.
I. Background
EPA is proposing to modify the significant new use requirements for
the following chemical substance under 40 CFR part 721, subpart E. In
this unit, EPA provides a brief description for the substance,
including its PMN number, chemical name (generic name if the specific
name is claimed as CBI), CAS number (if assigned), basis for the
modification of the section 5(e) consent order for the substance, and
the CFR citation in the regulatory text section of this proposed rule.
Further background information for the substance is contained in the
rulemaking record referenced in Unit IV., of this preamble.
PMN Number P-89-632
Chemical name: 1,3-Propanediamine, N,N"-1,2-ethanediylbis-, polymer
with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-
2,2,6,6-tetramethyl-4-piperidinamine
CAS number: Not available.
Effective date of modification of section 5(e) consent order: September
23, 1994.
Basis for modification of section 5(e) consent order: Based on the
results of a 90-day oral toxicity study on the PMN substance, the
Company petitioned EPA to reconsider the consent order's worker
protection and hazard communication requirements. The Company
petitioned the Agency to modify the consent order and SNUR to (1)
Broaden the choice of workplace protective equipment to include two 21C
air-purifying respirators with high efficiency particulate filters and
(2) remove ``reproductive effects'' from the list of human health
hazards to be included on the Material Safety Data Sheet or label
accompanying shipments of the PMN substance. EPA, through written
correspondence, negotiations, and meetings with the Company,
recalculated the risk assessment of the PMN based on the test data
provided by the Company. Based on this risk assessment, the Agency
determined that the broader choice of respirators would provide
adequate protection against an unreasonable risk of systemic effects to
workers who may be exposed to the PMN substance via inhalation. The
Agency also believes that there was no evidence of reproductive
toxicity in the results of the submitted data. This SNUR had
incorrectly listed ``birth defects'' rather than ``reproductive
effects'' in the Hazard Communication Program at 40 CFR 721.72.
Accordingly, the ``birth defects'' SNUR requirement (Sec. 721.72(a)(v))
is being removed, effective this modification, and ``reproductive
effects'' is being removed from the consent order. Finally, in response
to the Company's submission of aquatic toxicity testing protocols to
the Agency for review, the Company was informed that such testing would
no longer be required and related prohibitions on release of the PMN
substance to water would also be removed from the consent order. This
action is being taken based on test data on polycationic polymers
structurally similar to the PMN substance which have been submitted to
the Agency in the intervening period between the December 1989
signature of the consent order and the Company's submission of the
aquatic toxicity testing protocols. These test data indicate that the
PMN substance, because of its physical/chemical properties (i.e.,
charge density of 4.8 percent amine nitrogen, low water solubility (<10
mg/L), and does not appear to be self-dispersing in water), will bind
quickly to naturally-occurring dissolved organic carbon in surface
waters and settle in sediment, where it is not expected to be
bioavailable. As a result, the toxicity to aquatic and sediment-
dwelling organisms is expected to be mitigated significantly, such that
the Agency no longer finds that the PMN substance will pose an
unreasonable risk of injury to the environment. Accordingly, the
testing requirement for toxicity to aquatic organisms and the
associated hazard communication language, prohibition on release to
water, and recordkeeping provisions related to these restrictions are
also removed by this modification to the consent order. The Agency has
determined, therefore, that modifying the consent order and SNUR would
not pose an unreasonable risk to human health or the environment.
CFR citation: 40 CFR 721.7280.
II. Objectives and Rationale of Proposing Modification of the Rule
During review of the PMN submitted for the chemical substance that
is the subject of this proposed modification, EPA concluded that
regulation was warranted under section 5(e) of TSCA pending the
development of information sufficient to make a reasoned evaluation of
the health and environmental effects of the substance. EPA identified
the tests considered necessary to evaluate the risks of the substance
and identified the protective equipment necessary to protect any
workers who may be exposed to the substance. The basis for such
findings is in the rulemaking record referenced in Unit III. of this
preamble. Based on these findings, a section 5(e) consent order
modification was negotiated with the PMN submitter.
In light of the petition to modify the consent order and SNUR, the
90-day subchronic test, the data on structurally similar polycationic
polymers, and the recalculation of the risk assessment of the PMN
substance based on information provided by the petitioner, the Agency
determined that modifying the consent order and SNUR would not pose an
unreasonable risk to human health or the environment. The proposed
modification of SNUR provisions for the substance designated herein is
consistent with the provisions of the section 5(e) order.
III. Rulemaking Record
The record for the rule which EPA is proposing to modify was
established at OPPTS-50582. This record includes information considered
by the Agency in developing this rule (including comments and data
submitted electronically as described below) and includes the
modification to consent orders to which the Agency has responded with
this proposal.
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 public record is located
in the TSCA Nonconfidential Information Center, [[Page 28077]] Rm. NE-
B607, 401 M St., SW., Washington, DC 20460.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
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 will be treated in accordance with the procedures in 40
CFR part 2. Any party submitting comments claimed to be confidential
must prepare and submit a public version of the comments that EPA can
place in the public file.
V. Regulatory Assessment Requirements
EPA is modifying the requirements of the rule by eliminating
several requirements. Any costs or burdens associated with the rule
will be reduced when the rule is modified. Therefore, EPA finds that no
additional assessments of costs or burdens are necessary under
Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C.
605(b)), or the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements, Significant new uses.
Dated: May 16, 1995.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended to read
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. In Sec. 721.7280 by revising paragraphs (a)(2)(i) and
(a)(2)(ii), removing paragraphs (a)(2)(iii) and (a)(2)(iv), and
revising paragraph (b)(1) to read as follows:
Sec. 721.7280 1,3-Propanediamine, N,N"-1,2-ethanediylbis-, polymer
with 2,4,6-trichloro-1,3,5-triazine, reaction products with N-butyl-
2,2,6,6-tetramethyl-4-piperidinamine
(a) * * *
(2) * * *
(i) Protection in the workplace. Requirements as specified in
Sec. 721.63(a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(i), (a)(5)(ii),
(a)(5)(iv), (a)(5)(v), (a)(6)(i), (a)(6)(ii), (b)(concentration set at
0.1 percent) and (c).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (f), (g)(1)(iv), (g)(1)(viii), (g)(2)(i),
(g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), and (g)(5).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in
Sec. 721.125(a) through (i) are applicable to manufacturers, importers,
and processors of this substance.
* * * * *
[FR Doc. 95-13135 Filed 5-26-95; 8:45 am]
BILLING CODE 6560-50-F