[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.
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[FR Doc. 95-13135 Filed 5-26-95; 8:45 am]
BILLING CODE 6560-50-F