[Federal Register Volume 67, Number 183 (Friday, September 20, 2002)]
[Proposed Rules]
[Pages 59233-59236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23749]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPT-2002-0031; FRL-7187-1]
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 four 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 or premanufacture 
notices (PMN) for these chemical substances may result in significant 
changes in human or environmental exposure.

DATES: Comments, identified by docket ID number OPPT-2002-0031, must be 
received on or before October 21, 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 ID 
number OPPT-2002-0031 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 
(7408M), Office of Pollution Prevention and Toxics, 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
------------------------------------------------------------------------

    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 or 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 ID number OPPT-2002-0031. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment

[[Page 59234]]

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 EPA Docket Center, Rm. B102-Reading Room, EPA 
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket 
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The EPA Docket Center Reading Room telephone 
number is (202) 566-1744 and the telephone number for the OPPT Docket, 
which is located in EPA Docket Center, is (202) 566-0280.

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 ID number OPPT-2002-0031 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Document Control Office 
(7407M), 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 and data 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 ID number OPPT-2002-0031. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information 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 have not 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 rule.
    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 
ID 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.

II. Background

A. What Action is the Agency Taking?

    In the Federal Register referenced for each substance, OPPTS-50577, 
June 26, 1990 (55 FR 26111), OPPTS-50588, November 6, 1990 (55 FR 
46773), OPPTS-50622, August 30, 1995 (60 FR 45082) (FRL-4629-2), OPPTS-
50632, August 20, 1998 (63 FR 44575) (FRL-5788-7), 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 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-86-1491
Chemical name: 3-Hydroxy-1,1-dimethylbutyl derivative (generic).
CAS number: Not applicable.
Federal Register publication date and reference: August 30, 1995 (60 FR 
45082).
Docket number: OPPTS-50622.
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-86-1491 may present an unreasonable risk under section 5(e) of TSCA 
and has, therefore, revoked the consent order for P-86-1491. 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 721.4466.

PMN Number P-86-1492
Chemical name: Alkyl peroxy-2-ethyl hexanoate (generic).
CAS number: Not applicable.
Federal Register publication date and reference: November 6, 1990 (55 
FR 46773).

[[Page 59235]]

Docket number: OPPTS-50588.
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-86-1492 may present an unreasonable risk under section 5(e) of TSCA 
and has, therefore, revoked the consent order for P-86-1492. 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 721.4240 (Formerly 40 CFR 721.1208).

PMN Number P-86-1493
Chemical name: Substituted alkyl peroxyhexane carboxylate (mixed 
isomers) (generic).
CAS number: Not applicable.
Federal Register publication date and reference: June 26, 1990 (55 FR 
26111).
Docket number: OPPTS-50577.
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-86-1493 may present an unreasonable risk under section 5(e) of TSCA 
and has, therefore, revoked the consent order for P-86-1493. 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 721.4200 (Formerly 40 CFR 721.1565).

PMN Number P-98-24
Chemical name: Methoxy benzoic acid derivative (generic).
CAS number: Not applicable.
Federal Register publication date and reference: August 20, 1998 (63 FR 
44575).
Docket number: OPPTS-50632.
Basis for revocation of SNUR: EPA issued a SNUR for this substance 
based on the concern criteria at Sec.  721.170(b)(4)(1). The PMN 
submitter petitioned EPA to revoke the SNUR based on existing toxicity, 
fate, and economic data. The results of acute fish, daphnia, and algae 
studies for the substance demonstrated acute LC50 values 
ranging from 60-90 parts per million (ppm). EPA's concern concentration 
of 40 parts per billion (ppb) for the substance is based on potential 
chronic toxicity. A biodegradation study for the PMN substance measured 
90% degradation in 28 days. Commercial use of the PMN substance is 
limited to use as a mediator in enzyme catalyzed reactions. In 
addition, EPA expects that most of the PMN substance is destroyed when 
used in this manner resulting in little or no release of the substance. 
EPA could not identify additional uses of the PMN substance. Based on 
this data EPA can no longer make the finding that reasonably 
anticipated conditions of release may result in significant releases 
above 40 ppb. Therefore, EPA has concluded that based on available 
information, the substance does not meet the concern criteria at Sec.  
721.170(b)(4)(1).
CFR citation: 40 CFR 721.1710.

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 or PMN 
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 or PMN 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.
    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. Statutory and Executive Order Reviews

    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.
    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.
    Since this proposed rule does not impose any requirements it does 
not require any other action under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action 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, entitled 
Federalism (64 FR 43255, August 10, 1999).
    This proposed rule does not have tribal implications because it is 
not expected to have substantial direct effects on Indian Tribes. This 
does not 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 Executive Order 
13175 entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR

[[Page 59236]]

67249, November 6, 2000), do not apply to this proposed rule.
    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.
    This proposed rule is not subject to Executive Order 13211, 
entitled Actions Concerning Regulations That Significantly Affect 
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), 
because this action is not expected to affect energy supply, 
distribution, or use.
    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), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.
    This action does not involve special considerations of 
environmental justice related issues 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).
    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 proposed 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.
    In issuing this proposed 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).

List of Subjects in 40 CFR Part 721

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


    Dated: September 5, 2002.
Charles M. Auer,
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).


Sec. Sec.  721.1710, 721.4200, 721.4240, and 721.4466  [Removed]

    2. By removing Sec. Sec.  721.1710, 721.4200, 721.4240, and 
721.4466.

[FR Doc. 02-23749 Filed 9-19-02; 8:45 am]
BILLING CODE 6560-50-S