[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Proposed Rules]
[Pages 12950-12953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6724]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50646; FRL-6820-7]
RIN 2070-AB27


Proposed Revocation of Significant New Uses of Certain Chemical 
Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke significant new use rules (SNURs) 
for eight substances promulgated under section 5(a)(2) of the Toxic 
Substances Control Act (TSCA) based on new data. Based on the new data 
the Agency no longer finds that activities not described in the 
corresponding TSCA section 5(e) consent orders for these chemical 
substances may result in significant changes in human or environmental 
exposure.

DATES: Comments, identified by docket control number OPPTS-50646 must 
be received on or before April 19, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPPTS-50646 in the subject line on the first page of 
your response.

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 
proposed revocation. 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
------------------------------------------------------------------------


[[Page 12951]]

    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-50646. 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 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPPTS-50646 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in EPA East Building Rm. 6428, 1201 Constitution 
Ave. NW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 564-8930.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments will also be accepted on standard disks in WordPerfect 6.1/8.0 
or ASCII file format. All comments in electronic form must be 
identified by docket control number OPPTS-50646. Electronic comments 
may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we haven't considered, the potential impacts of 
the various options (including possible unintended consequences), and 
any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed revocation.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

[[Page 12952]]

II. Background

A. What Action is the Agency Taking?

    In the Federal Register referenced for each substance, OPPTS-50601, 
September 23, 1992 (57 FR 44068), OPPTS-50620, March 1, 1995 (60 FR 
11044) (FRL-4868-4), and OPPTS-50623, December 2, 1996 (61 FR 63737) 
(FRL-4964-3), establishing significant new uses for the substances, EPA 
issued a SNUR. Because of additional data EPA has received for these 
substances, EPA is proposing to revoke 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 each substance, including its premanufacture notice 
(PMN) number, chemical name (generic name if the specific name is 
claimed as CBI), CAS number (if assigned), basis for the revocation of 
the TSCA section 5(e) consent order for the substance, and the CFR 
citation. Further background information for the substances is 
contained in Unit I.B.2 of this document.

PMN Number P-89-764
Chemical name: Neodecaneperoxoic acid, 1,1,3,3-tetramethylbutyl ester.
CAS number: 51240-95-0.
Federal Register publication date and reference: September 23, 1992 (57 
FR 44068).
Docket number: OPPTS-50601.
Basis for revocation of SNUR: EPA issued a TSCA section 5(e) consent 
order between EPA and the PMN submitter for this substance based on a 
potential unreasonable risk of cancer by analogy to structurally 
similar peroxides. Based on the results of test data developed by an 
industry consortium to address potential toxicity of peroxides, EPA has 
concluded that available information does not support identification of 
peroxides as potential carcinogens. Therefore, EPA determined that it 
could no longer conclude that the manufacturing, processing, and use of 
P-89-764 may present an unreasonable risk under section 5(e) of TSCA 
and has, therefore, revoked the consent order for P-89-764. EPA can no 
longer make the finding that activities not described in the TSCA 
section 5(e) consent order may result in significant changes in human 
exposure.
CFR citation: 40 CFR 721.5300.

PMN Number P-93-193
Chemical name: Propanol, [2-(1,1-dimethylethoxy)methylethoxy]-.
CAS number: 132739-31-2.
Federal Register publication date and reference: March 1, 1995 (60 FR 
11044).
Docket number: OPPTS-50620.
Basis for revocation of SNUR: EPA issued a consent order between EPA 
and the PMN submitter requiring submission to EPA of certain human 
health and environmental toxicity testing before manufacturing a 
specified amount of the PMN substance based on the fact that the PMN 
substance would be produced in substantial quantities, and that there 
might be significant or substantial human exposure to the PMN 
substance. Based on the results of these studies, potential exposures, 
and the toxicity of the compounds the PMN substance will replace, EPA 
determined that it could no longer conclude that the manufacturing, 
processing, and use of P-93-193 may present an unreasonable risk under 
section 5(e) of TSCA and has, therefore, revoked the consent order for 
P-93-193. EPA can no longer make the finding that activities not 
described in the TSCA section 5(e) consent order may result in 
significant changes in human exposure.
CFR citation: 40 CFR 721.8170.

PMN Numbers P-94-1634/1635/1636/1637/1638/1639
Chemical name: Fatty acids, C(14-18)-unsaturated, branched and linear, 
methyl and butyl esters.
CAS number: Not available.
Federal Register publication date and reference: December 2, 1996 (61 
FR 63737).
Docket number: OPPTS-50623.
Basis for revocation of SNUR: EPA issued a consent order between EPA 
and the PMN submitter requiring submission to EPA of certain human 
health toxicity testing before manufacturing a specified amount of the 
PMN substances based on the fact that the PMN substances would be 
produced in substantial quantities, and that there might be significant 
or substantial human exposure to the PMN substances. EPA revoked the 
consent order based on the PMN submitter's commitment to sponsor the 
substances under EPA's High Production Volume (HPV) Challenge Program 
and the expectation that the information and/or test data developed by 
the company pursuant to its HPV commitment will satisfy EPA's 
information needs for the PMN substances. EPA can no longer make the 
finding that activities not described in the TSCA section 5(e) consent 
order may result in significant changes in human exposure.
CFR citation: 40 CFR 721.3628.

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

    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) of TSCA. 
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 
substance for that use. The mechanism for reporting under this 
requirement is established under 40 CFR 721.5.
    During review of the PMNs submitted for the chemical substances 
that are the subject of this proposed revocation, EPA concluded that 
regulation was warranted based on available information that indicated 
activities not described in the TSCA section 5(e) consent order might 
result in significant changes in human or environmental exposure as 
described in section 5(a)(2) of TSCA. Based on these findings, SNURs 
were promulgated.
    EPA has revoked the TSCA section 5(e) consent orders that are the 
basis for these SNURs and no longer finds that activities other than 
those described in the TSCA section 5(e) consent orders may result in 
significant changes in human or environmental exposure. The revocation 
of SNUR provisions for these substances is consistent with the findings 
set forth in the preamble to the proposed revocation of each individual 
SNUR.

[[Page 12953]]

    Therefore, EPA is proposing to revoke the SNUR provisions for these 
chemical substances. When this revocation becomes final, EPA will no 
longer require notice of intent to manufacture, import, or process 
these substances. In addition, export notification under section 12(b) 
of TSCA will no longer be required.

III. Regulatory Assessment Requirements

    This proposed rule revokes or eliminates an existing regulatory 
requirement and does not contain any new or amended requirements. As 
such, the Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
    Since this proposed rule does not impose any requirements, it does 
not contain any information collections subject to approval under the 
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or require any 
other action under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).
    Nor does it require any prior consultation as specified by 
Executive Order 12875, entitled ``Enhancing the Intergovernmental 
Partnership'' (58 FR 58093, October 28, 1993), or special 
considerations as required by Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994) or require OMB 
review in accordance with Executive Order 13045, entitled ``Protection 
of Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997).
    On August 4, 1999, President Clinton issued a new executive order 
on ``Federalism,'' Executive Order 13132 (64 FR 43255, August 10, 
1999). This proposed rule will not 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.
    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 SNUR revocations, which eliminate requirements without imposing 
any new ones, have no adverse economic impacts.
    This proposed 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.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.


    Dated: March 1, 2002.
William H. Sanders, III,
Office 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).


Secs. 721.3628, 721.5300, and 721.8170  [Removed]

    2. By removing Secs. 721.3628, 721.5300, and 721.8170.

[FR Doc. 02-6724 Filed 3-19-02; 8:45 am]
BILLING CODE 6560-50-S