[Federal Register Volume 62, Number 236 (Tuesday, December 9, 1997)]
[Rules and Regulations]
[Pages 64738-64740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32179]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50608E; FRL-5746-2]
RIN 2070-AB27


Polyalkylene Polyamine; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is issuing a significant new use rule (SNUR) under section 
5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical 
substance described as polyalkylene polyamine which is the subject of 
premanufacture notice (PMN) P-89-963. This rule would require certain 
persons who intend to manufacture, or import this substance for a 
significant new use to notify EPA at least 90 days before commencing 
any manufacturing or importing activities for a use designated by this 
SNUR as a significant new use. The required notice would provide EPA 
with the opportunity to evaluate the intended use and, if necessary, to 
prohibit or limit that activity before it can occur.

DATES: This rule is effective January 8, 1998.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, 
Environmental Assistance Division (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; e-mail: TSCA-H<a href="/cdn-cgi/l/email-protection#39564d5550575c795c495854585055175c4958175e564f"><span class="__cf_email__" data-cfemail="29465d4540474c694c594844484045074c5948074e465f">[email protected]</span></a>.

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 final SNUR would require persons to notify EPA at least 90 
days before commencing the manufacture or import of P-89-963 for the 
significant new uses designated herein. The required notice would 
provide EPA with information with which to evaluate an intended use and 
associated activities.

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). Once EPA 
determines that a use of a chemical substance is a 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 
chemical substance for that use. Section 26(c) of TSCA authorizes EPA 
to take action under section 5(a)(2) with respect to a category of 
chemical substances.
    Persons subject to this SNUR would comply with the same notice 
requirements and EPA regulatory procedures as submitters of 
premanufacture notices under section 5(a)(1) of TSCA. In particular, 
these requirements include the information submission requirements of 
section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1), 
(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. 
Once EPA receives a SNUR notice, EPA may take regulatory action under 
section 5(e), 5(f), 6, or 7 to control the activities for which it has 
received a SNUR notice. If EPA does not take

[[Page 64739]]

action, section 5(g) of TSCA requires EPA 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 section 12(b) appear at 
40 CFR part 707.

II. Applicability of General Provisions

    General regulatory provisions applicable to SNURs are codified at 
40 CFR part 721, subpart A. On July 27, 1988 (53 FR 28354) and July 27, 
1989 (54 FR 31298), EPA promulgated amendments to the general 
provisions which apply to this SNUR. In the Federal Register of August 
17, 1988 (53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR 
part 700) under the authority of TSCA section 26(b). Provisions 
requiring persons submitting SNUR notices to submit certain fees to EPA 
are discussed in detail in that Federal Register document. Interested 
persons should refer to these documents for further information.

III. Background and Response to Comments

    EPA published a direct final SNUR for the chemical substance, which 
was the subject of (PMN) P-89-963 and a TSCA 5(e) consent order issued 
by EPA, in the Federal Register of June 8, 1993 (58 FR 32227). EPA 
received a notice of intent to submit adverse comments for this 
chemical substance following publication. Therefore, as required by 
Sec. 721.160, the final SNUR for P-89-963 was withdrawn on December 19, 
1994 (59 FR 65248) (FRL-4758-2), and a proposed rule on the substance 
was issued on December 19, 1994 (59 FR 65289) (FRL-4758-3).
    The background and reasons for the SNUR were set forth in the 
preamble to the proposed rule. EPA received comments from the current 
manufacturer of the PMN substance. EPA's response to the comments and 
changes to the proposed rule are discussed in this document.
    All but one of the comments can be summarized as follows: Since the 
5(e) consent order requires only that manufacturers and importers be 
subject to hazard communication requirements concerning environmental 
effects, water release restrictions, and recordkeeping requirements, 
the SNUR should reflect similar regulation, and processors should not 
be subject to these SNUR requirements. EPA agrees with this 
clarification. The proposed SNUR would have required that only 
manufacturers notify the Agency if the substance was released to water. 
In addition, EPA is revising both the hazard communication and 
recordkeeping sections to make it clear that only manufacturers and 
importers are subject to the requirements of the SNUR.
    The other comment was that since the toxicity testing (a 28-day 
oral study in rats) required by the 5(e) consent order at a designated 
production volume limit had already been completed and submitted to 
EPA, the corresponding production volume limit in the proposed SNUR 
should not be included in the final SNUR. EPA agrees and accordingly 
has eliminated this notification requirement from the final SNUR. In 
addition, the hazard communication requirements designated in the 
proposed SNUR at Sec. 721.72 (a)(2)(i)(A) and (B) have been eliminated. 
These requirements would have compelled manufacturers, importers, or 
processors to incorporate into a Material Safety Data Sheet (MSDS) any 
risks to human health and methods for protecting against such risk, if 
such risks were demonstrated by the results of toxicity testing 
required under the section 5(e) consent order. EPA eliminated these 
requirements, since the order and the SNUR no longer require toxicity 
testing and the test data already submitted did not warrant additional 
hazard communication notification.

IV. Applicability of SNUR to Uses Occurring Before Effective Date 
of the Final SNUR

    EPA has decided that the intent of section 5(a)(1)(B) is best 
served by designating a use as a significant new use as of the date of 
proposal rather than as of the effective date of the rule. Because this 
SNUR was first published on June 8, 1993, as a direct final rule, that 
date will serve as the date after which uses would be considered to be 
new uses. If uses which had commenced between that date and the 
effective date of this rulemaking were considered ongoing, rather than 
new, any person could defeat the SNUR by initiating a significant new 
use before the effective date. This would make it difficult for EPA to 
establish SNUR notice requirements. Thus, persons who begin commercial 
manufacture, import, or processing of the substance for uses that would 
be regulated through this SNUR after June 8, 1993, would have to cease 
any such activity before the effective date of this rule. To resume 
their activities, such persons would have to comply with all applicable 
SNUR notice requirements and wait until the notice review period, 
including all extensions, expires. EPA, not wishing to unnecessarily 
disrupt the activities of persons who begin commercial manufacture, 
import, or processing for a proposed significant new use before the 
effective date of the SNUR, has promulgated provisions to allow such 
persons to comply with this SNUR before it is promulgated. If a person 
were to meet the conditions of advance compliance as codified at 
Sec. 721.45(h) (53 FR 28354, July 17, 1988), the person would be 
considered to have met the requirements of the SNUR for those 
activities. If persons who begin commercial manufacture, import, or 
processing of the substance between proposal 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.

V. Economic Analysis

    EPA has evaluated the potential costs of establishing significant 
new use notice requirements for potential manufacturers, and importers 
of the chemical substance at the time of the direct final rule. The 
analysis is unchanged for the substance in the final rule. The Agency's 
complete economic analysis is available in the public record for this 
final rule (OPPTS-50608E).

VI. Public Record

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number OPPTS-50608E (including comments and data submitted 
electronically). 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.

VII. Regulatory Assessment Requirements

    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

[[Page 64740]]

(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).
    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.
    In addition, pursuant to section 605(b) of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined 
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.

VIII. 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 of Representatives, 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 substances, 
Reporting and recordkeeping requirements.

    Dated: November 24, 1997.

Charles M. Auer,

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. 721.6193 to subpart E to read as follows:


Sec. 721.6193   Polyalkylene polyamine.

    (a) Chemical substance and significant new uses subject to 
reporting. (1) The chemical substance generically identified as a 
polyalkylene polyamine (PMN P-89-963) 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)(4) (users minimize 
release to water), and (g)(5) are applicable to manufacturers and 
importers.
    (ii) Release to water. Requirements as specified in 
Sec. 721.90(a)(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), (i), and (k) are applicable 
to manufacturers and importers of this substance.
    (2) Limitations or revocation of certain notification requirements. 
The provisions of Sec. 721.185 apply to this section.

[FR Doc. 97-32179 Filed 12-8-97; 8:45 am]
BILLING CODE 6560-50-F


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