[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Rules and Regulations]
[Pages 12879-12882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6726]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50644A; FRL-6817-8]
RIN 2070-AB27


Modification of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act 
(TSCA) and 40 CFR 721.185, EPA is amending three significant new use 
rules (SNURs) to allow certain uses without requiring a significant new 
use notice (SNUN). EPA is amending these rules based on review of new 
toxicity test data on one chemical and review of SNUNs for the other 
two chemicals. The amended SNURs would continue to require a SNUN for 
new uses that may involve significant changes in human or environmental 
exposure.

DATES: This rule is effective May 20, 2002.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division, 
Office of Pollution Prevention and Toxics (7408M), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: James Alwood, Chemical Control 
Division, Office of Pollution Prevention and Toxics (7405M), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-8974; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Chemical manufacturers            325                 Manufacturers,
                                                       importers,
                                                       processors, and
                                                       users of
                                                       chemicals
Petroleum and coal product        324                 Manufacturers,
 industries                                            importers,
                                                       processors, and
                                                       users of
                                                       chemicals
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table in this unit 
could also be affected. The North American Industrial Classification 
System (NAICS) codes have been provided to assist you and others in 
determining whether or not this action applies to certain entities. To 
determine whether you or your business is affected by this action, you 
should carefully examine the applicability provisions in title 40 of 
the Code of Federal Regulations (CFR) at 40 CFR 721.5. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 721 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr721_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-50644A. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during

[[Page 12880]]

an applicable comment period, is available for inspection in the TSCA 
Nonconfidential Information Center, North East Mall Rm. B-607, 
Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from 
noon to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Center is (202) 260-7099.

II. Background

A. What Action is the Agency Taking?

    The Agency proposed the modification of these SNURs in the Federal 
Register of October 30, 2001 (66 FR 54742) (FRL-6798-7). The background 
and reasons for the modification of each individual SNUR are set forth 
in the preamble to the proposed SNUR modification. The comment period 
closed on November 29, 2001. EPA received no comments regarding these 
SNURS. Therefore, EPA is issuing the modified SNURs.

B. What is the Agency's Authority for Taking this Action?

    TSCA section 5(a)(2) and 40 CFR part 721 authorize 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 
promulgates a rule designating ``significant new uses'' for a given 
chemical substance, 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 721.5.
    Section 5(a)(1) of TSCA (15 U.S.C. 2604(a)(1)) and its implementing 
regulations at 40 CFR parts 720 and 721 require that any person 
intending to manufacture a new chemical substance, or to manufacture or 
process any chemical substance for a significant new use, must give EPA 
90-days advance written notice in the form of a pre-manufacture notice 
(PMN) or SNUN, respectively.
    Upon reviewing those notices, if EPA makes certain determinations 
regarding potential exposures and risks that may be presented by the 
activities associated with the chemical, EPA may regulate the chemical 
by issuing an order under TSCA section 5(e) and/or a SNUR under TSCA 
section 5(a)(2) and 40 CFR part 721. The TSCA section 5(e) order 
governs only the entity who submitted the PMN, whereas the section 
5(a)(2) SNUR applies to all manufacturers and processors of the same 
chemical.
    EPA may respond to SNUNs by issuing or modifying a TSCA section 
5(e) consent order and/or amending the SNUR promulgated under TSCA 
section 5(a)(2). Amendment of the SNUR will often be necessary to allow 
companies other than the SNUN submitter to engage in the newly 
authorized use(s), because even after a manufacturer submits a SNUN and 
the review period expires, processors of the same substance still must 
submit a SNUN before engaging in the significant new use. Provisions 
regarding EPA's authority to modify or revoke SNUR requirements appear 
at 40 CFR 721.185.
    EPA responded to PMN P-95-1411 by issuing a TSCA section 5(e) 
consent order and TSCA section 5(a)(2) SNUR to address concerns for 
both human health and the environment. Based on data from a 90-
subchronic oral toxicity study in rats, submitted pursuant to the terms 
of the 5(e) consent order, EPA however, no longer concludes that the 
PMN substance may present an unreasonable risk to human health. 
Therefore, EPA has revoked the section 5(e) consent order entirely and, 
pursuant to TSCA section5(a)(2) and 40 CFR 721.185, is amending the 
SNUR to remove the human health related notice requirements, leaving 
only the notification requirements related to environmental releases.
    EPA responded to PMNs P-97-520/521 by issuing a TSCA section 5(e) 
consent order requiring certain testing based on expected substantial 
human and environmental exposures and promulgating a TSCA section 
5(a)(2) SNUR to address concerns for human health. In response to SNUNs 
S-00-397/398 by the same manufacturer proposing new uses for the same 
chemicals, EPA modified the section 5(e) consent order to allow certain 
new uses, but with restrictions to mitigate potential risks to human 
health. Accordingly, pursuant to TSCA section 5(a)(2) and 40 CFR 
721.185, EPA is hereby amending the corresponding SNURs to modify the 
significant new uses consistent with the terms of the modified section 
5(e) consent order and to provide EPA an opportunity to assess the 
potential for significant changes in human or environmental exposure.

C. Applicability of General Provisions

    General provisions for SNURs appear under subpart A of 40 CFR part 
721. These provisions describe persons subject to the final rule, 
recordkeeping requirements, exemptions to reporting requirements, and 
applicability of the final 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), 
(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 
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. Regulatory Assessment Requirements

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that proposed or final SNURs are not a 
``significant regulatory action'' subject to review by OMB, because 
they do not meet the criteria in section 3(f) of the Executive Order.
    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reasons to believe that any 
State, local, or tribal government will be impacted by this rulemaking. 
As such, EPA has determined that this regulatory action does not impose 
any enforceable duty, contain any unfunded mandate, or otherwise have 
any affect on small governments subject to the requirements of sections 
202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).
    This rule does not have tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
does not

[[Page 12881]]

significantly or uniquely affect the communities of Indian tribal 
governments, nor does it involve or impose any requirements that affect 
Indian Tribes. Accordingly, the requirements of section 3(b) of 
Executive Order 13084, entitled Consultation and Coordination with 
Indian Tribal Governments (63 FR 276755, May 19, 1998), do not apply to 
this rule. Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000), which took effect on January 6, 2001, revokes Executive Order 
13084 as of that date. EPA developed this rulemaking, however, during 
the period when Executive Order 13084 was in effect; thus, EPA 
addressed tribal considerations under Executive Order 13084. For the 
same reasons stated for Executive Order 13084, the requirements of 
Executive Order 10175 do not apply to this rule either. Nor will this 
action have a substantial direct effect on States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999).
    In issuing this rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).
    EPA has complied with Executive Order 12630, entitled Governmental 
Actions and Interference with Constitutionally Protected Property 
Rights (53 FR 8859, March 15, 1988), by examining the takings 
implications of this rule in accordance with the ``Attorney General's 
Supplemental Guidelines for the Evaluation of Risk and Avoidance of 
Unanticipated Takings'' issued under the Executive Order.
    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.
    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA) Pub. L. 104-113 section 12(d) (15 
U.S.C. 272 note), does not apply to this action.
    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR will not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is as follows. 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 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 900 SNURs, the 
Agency has received fewer than 25 SNUNs. Of those SNUNs submitted, none 
appear to be from small entities in response to any SNUR. In addition, 
the estimated reporting cost for submission of a SNUN is minimal 
regardless of the size of the firm. Therefore, EPA believes that the 
potential economic impact of complying with this SNUR are not expected 
to be significant or adversely impact a substantial number of small 
entities. In a SNUR that published on June 2, 1997 (62 FR 29684) (FRL-
5597-1), the Agency presented it's general determination that proposed 
and final SNURs are not expected to have a significant economic impact 
on a substantial number of small entities, which was provided to the 
Chief Counsel for Advocacy of the Small Business Administration.
    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that requires OMB 
approval under the PRA, unless it has been approved by OMB and displays 
a currently valid OMB control number. The OMB control numbers for EPA's 
regulations, after initial display in the preamble of the final rule 
and in addition to its display on any related collection instrument, 
are listed in 40 CFR part 9.
    The information collection requirements related to this action have 
already been approved by OMB pursuant to the PRA under OMB control 
number 2070-0012 (EPA ICR No. 574). This action does not impose any 
burden requiring additional OMB approval. If an entity were to submit a 
SNUN to the Agency, the annual burden is estimated to average between 
30 and 170 hours per response. This burden estimate includes the time 
needed to review instructions, search existing data sources, gather and 
maintain the data needed, and complete, review, and submit the required 
SNUN.
    Send any comments about the accuracy of the burden estimate, and 
any suggested methods for minimizing respondent burden, including 
through the use of automated collection techniques, to the Director, OP 
Regulatory Information Division (2137), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Please 
remember to include the OMB control number in any correspondence, but 
do not submit any completed forms to this address.
    This rule is not subject to Executive Order 13211, ``Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a 
significant regulatory action under Executive Order 12866.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule 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.



[[Page 12882]]


    Dated: March 1, 2002.
William H. Sanders, III
Office Director, 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. Section 721.4589 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1), (a)(2)(i), and (b)(1).
    c. By removing and reserving paragraph (a)(2)(ii).
    d. By removing paragraphs (a)(2)(iii), (a)(2)(iv), and (b)(3).


Sec. 721.4589  Propanedioic acid, [(4-methoxyphenyl)methylene]-, 
bis(1,2,2,6,6-pentamethyl-4-piperdinyl) ester (9CI).

    (a) *  *  * (1) The chemical substance identified as propanedioic 
acid, [(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-
piperdinyl) ester (9CI) (PMN P-95-1411; CAS No. 147783-69-5) is subject 
to reporting under this section for the significant new uses described 
in paragraph (a)(2) of this section.
    (2) *  *  *
    (i) Release to water. Requirements as specified in Sec. 721.90 
(a)(1), (b)(1), and (c)(1).
    (ii) [Reserved]
    (b) *  *  *
    (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.
* * * * *

    3. Section 721.6175 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1), (a)(2)(i), and (b)(1).
    c. By adding paragraphs (a)(2)(ii), (a)(2)(iii), and (b)(3).


Sec. 721.6175  2-Piperdinone, 1,3-dimethyl-,.

    (a) *  *  * (1) The chemical substance identified as 2-Piperdinone, 
1,3-dimethyl-, (PMN P-97-520 and SNUN 00-397; CAS No. 1690-76-2) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) *  *  *
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), 
(g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k) (use or processing other than: in 
enclosed systems (such as hydrocarbon extraction, polymer synthesis, 
wire enamel resin); electronic industry cleaning solvent; and other 
precision industry cleaning (such as automobile manufacturing, 
aerospace, and optics)), (o), and (q).
    (b) *  *  *
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
* * * * *
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this substance.

    4. Section 721.6176 is amended as follows:
    a. By revising the section heading.
    b. By revising paragraphs (a)(1), (a)(2)(i), and (b)(1).
    c. By adding paragraphs (a)(2)(ii), (a)(2)(iii), and (b)(3).


Sec. 721.6176  2-Piperdinone, 1,5-dimethyl-,.

    (a) *  *  * (1) The chemical substance identified as 2-Piperdinone, 
1,5-dimethyl-, (PMN P-97-521 and SNUN 00-398; CAS No. 86917-58-0) is 
subject to reporting under this section for the significant new uses 
described in paragraph (a)(2) of this section.
    (2) *  *  *
    (i) Protection in the workplace. Requirements as specified in 
Sec. 721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1.0 
percent), and (c).
    (ii) Hazard communication program. Requirements as specified in 
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), 
(f), (g)(1)(i), (g)(1)(iii), (g)(1)(iv), (g)(1)(ix), (g)(2)(i), 
(g)(2)(v), and (g)(5).
    (iii) Industrial, commercial, and consumer activities. Requirements 
as specified in Sec. 721.80(k) (use or processing other than: in 
enclosed systems (such as hydrocarbon extraction, polymer synthesis, 
wire enamel resin); electronic industry cleaning solvent; and other 
precision industry cleaning (such as automobile manufacturing, 
aerospace, and optics)), (o), and (q).
    (b) *  *  *
    (1) Recordkeeping. The recordkeeping requirements specified in 
Sec. 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are 
applicable to manufacturers, importers, and processors of this 
substance.
* * * * *
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec. 721.1725(b)(1) apply to this substance.

[FR Doc. 02-6726 Filed 3-19-02; 8:45 am]
BILLING CODE 6560-50-S