[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Proposed Rules]
[Pages 54646-54649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27386]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42190A; FRL-6029-8]
RIN 2070-AC76


Dimethyl Adipate, Dimethyl Glutarate, Dimethyl Succinate; Export 
Notification Requirements

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: Under the authority of the Toxic Substances Control Act (TSCA) 
sections 4 and 12(b)(1), EPA is proposing to require that exporters of 
certain dibasic esters (DBEs) (consisting of dimethyl adipate (CAS No. 
627-93-0) (DMA), dimethyl glutarate (CAS No. 1119-40-0) (DMG), and 
dimethyl succinate (CAS No. 106-65-0) (DMS)), be subject to TSCA 
12(b)(1) export notification requirements. These requirements would 
become effective following publication in the Federal Register of a 
testing consent order (Order) incorporating an enforceable consent 
agreement (ECA) that would require health effects testing on DMA, DMG, 
and DMS and the issuance of a final rule based on this proposed rule. 
When the TSCA section 12(b)(1) rule for DMA, DMG, and DMS becomes 
effective, all exporters of DMA, DMG, and DMS, including persons who 
either have signed or have not signed the ECA, would be required to 
comply with the export notification regulations under section 12(b)(1) 
of TSCA with regard to exports of DMA, DMG, and DMS.

DATES: Written comments, identified by the docket control number OPPTS-
42190A, must be received by EPA on or before December 14, 1998.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Follow the instructions for each method as provided in Unit 
I.C. of the SUPPLEMENTARY INFORMATION section of this preamble.

FOR FURTHER INFORMATION CONTACT: For technical information: George 
Semeniuk, Project Manager, Chemical Information and Testing Branch 
(7405), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone: 
(202) 260-2134; e-mail: [email protected].
    For additional information: Susan B. Hazen, Director, Environmental 
Assistance Division (7408), Rm. E-541, Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460; telephone: (202) 554-404, TDD: (202) 554-0551; e-
mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Would this proposed rule apply to me?

    You would be affected by this proposed rule if you export or intend 
to export one or more of the following DBEs: DMA (CAS No. 627-93-0), 
DMG (CAS No. 1119-40-0), or DMS (CAS No. 106-65-0) and if EPA has 
announced in the Federal Register that it has entered into an ECA for 
DMA, DMG, and DMS. Regulated categories and entities may include, but 
are not limited to:

------------------------------------------------------------------------
                                                Examples of Regulated
                 Category                             Entities
------------------------------------------------------------------------
Chemical exporters                          Persons who export
                                             or intend to export DMA,
                                             DMG, and/or DMS
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding examples of entities likely to be regulated 
by this action. Other types of entities not listed in this table could 
also be regulated. If you have any questions regarding the 
applicability of this action to a particular entity, consult the person 
listed as the technical contact in the ``FOR FURTHER INFORMATION 
CONTACT'' at the beginning of this document.

B. How can I get additional information, including copies of this 
document and support documents?

    1. Electronically. You may obtain electronic copies of this 
document and other available support documents on the Internet from the 
EPA Home Page at the ``Federal Register--Environmental Documents'' 
entry for this document     (http://www.epa.gov/fedrgstr/EPA-TOX/1998/
).
    2. In person. The official record for this proposed rule, including 
the public version, has been established under docket control number 
OPPTS-42190A. The public version of the record, including printed, 
paper versions of any electronic comments, which does not include any 
information claimed as Confidential Business Information (CBI), is 
available for inspection in the TSCA Nonconfidential Information 
Center, Rm. NE B-607, 401 M St., SW., Washington, DC. The Center is 
open from 12 noon to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the Center is (202) 260-7099.

[[Page 54647]]

C. How do I submit comments and to whom do I submit them?

    You may submit comments by mail, in person, or electronically:
    1. By mail. Submit written comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, Rm. G-099, East Tower, 401 M St., SW., Washington, 
DC 20460. The telephone number of the OPPT Document Control Office is 
(202) 260-7093.
    2.  In person. Deliver written comments to: OPPT Document Control 
Office, Environmental Protection Agency, Rm. G-099, East Tower, 401 M 
St., SW., Washington, DC.
    3. Electronically. Submit your comments electronically to: 
[email protected]. Submit electronic comments as an ASCII file avoiding 
the use of special characters and any form of encryption. Do not submit 
any information electronically that you consider to be CBI. Comments 
and data will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII 
file format. Submit computer disks to the address provided in Unit 
I.C.1. of this preamble. Identify all comments and data in electronic 
form by the docket control number OPPTS-42190A. Electronic comments on 
this proposed rule may also be filed online at many Federal Depository 
Libraries.

D. How should I handle information in my comments that I believe may be 
CBI?

    You may protect CBI within comments that you submit in response to 
this document by marking each piece of confidential information or the 
entire document as CBI in accordance with 40 CFR 2.203(b). Information 
marked in this way will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. CBI claims must be made at the 
time the information is submitted to EPA. Information not marked 
confidential will be made available to the public by EPA without prior 
notice. When you make CBI claims for particular comments, you must send 
EPA a copy of the comments with the CBI information deleted.

II. Authority

    This proposed rule is issued under the authority of TSCA sections 4 
and 12(b)(1) (15 U.S.C. 2603 and 2611(b)(1)) and 40 CFR part 707, 
subpart D.

III. Background

A. What is the ECA for DBEs?

    On March 22, 1995 (60 FR 15143) (FRL-4943-6), EPA solicited 
manufacturers and processors of DBEs, including DMA, DMG, and DMS, to 
develop and submit to EPA health effects testing proposals for these 
chemicals. EPA notified interested parties on December 20, 1996 (61 FR 
67332) (FRL-5578-9) of a public meeting to begin the negotiation of an 
ECA for DBEs. The public meeting was held on January 29, 1997. The 
Dibasic Esters Group (DBE Group), comprised of representatives from the 
Aceto Corporation, E.I. du Pont de Nemours Company, and Solutia Inc., 
and established under the Synthetic Organic Chemicals Manufacturers 
Association (SOCMA), indicated its interest in conducting the testing 
sought by EPA. On February 28, 1997, the DBE Group submitted draft 
protocols to EPA for five toxicity studies. The Agency reviewed this 
testing proposal and prepared a preliminary technical analysis which it 
sent to the DBE Group on May 21, 1998. A teleconference among 
interested parties was held on June 23, 1998 to negotiate an agreement. 
A draft ECA is being circulated for review among already-identified 
interested parties.
    The procedures for ECA negotiations are described at 40 CFR 
790.22(b).
    If an ECA for DBEs is agreed upon by EPA and the DBE Group, and an 
Order incorporating the ECA is signed by EPA, testing to develop needed 
data would be required of those non-governmental persons that sign the 
agreement. In addition, the ECA would incorporate the applicable export 
notification requirements of section 12(b)(1) of TSCA and 40 CFR part 
707, subpart D, which would apply to those non-governmental persons 
that have signed the ECA. Under TSCA section 12(b)(1) and 40 CFR part 
707, subpart D, if any person exports or intends to export to a foreign 
country a chemical substance or mixture for which the submission of 
data is required under section 4 of TSCA, that person shall notify EPA 
of this export or intent to export. Export notification requirements 
apply whenever data must be submitted under the authority of section 4 
of TSCA, regardless of whether the data must be submitted pursuant to a 
test rule, or an ECA and Order.

B. What would I be required to do under this proposed rule?

    If an ECA is concluded for DBEs, EPA would promulgate a final rule, 
based on this proposed rule, to add DMA, DMG, and DMS to the table in 
40 CFR 799.5000, entitled ``Testing consent orders for substances and 
mixtures with Chemical Abstract Service Registry Numbers.'' The final 
rule would require all exporters of DMA, DMG, and DMS, including 
persons who either have signed or have not signed the ECA for DBEs, to 
comply with export notification regulations. (See 40 CFR 799.19 and 40 
CFR part 707, subpart D).
     When you export or intend to export a chemical for which the 
submission of data is required under TSCA section 4 to a particular 
foreign country for the first time, you must submit a one-time 
notification to EPA identifying the chemical and country of import. 
(See also 40 CFR 707.65(a)(2)(ii)). A single notification can cover 
multiple chemicals and multiple countries. If you export or intend to 
export the same chemical to an additional country, you must submit an 
additional export notification to EPA. Other procedures for submitting 
export notifications to EPA and penalties for noncompliance are 
described in 40 CFR part 707, subpart D.

IV. Regulatory Assessment Requirements

A. Does this action require review by the Office of Management and 
Budget under Executive Orders 12866 or 13045?

    No. This action is not subject to review by the Office of 
Management and Budget (OMB) under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993), because 
it has been determined that this is not a ``significant regulatory 
action.'' In addition, this action does not require special OMB review 
under Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 1985, April 23, 
1997), because it does not raise any issues regarding children's 
environmental-health risks and it is not expected to have an economic 
impact of more than $100 million.

B. Will this action have disproportionate impacts on minorities or low-
income communities?

     No. This action does not involve special considerations of 
environmental-justice related issues pursuant to Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

C. Does this action involve any information collection activities, such 
as reporting, recordkeeping, or notification, that have not already 
been approved by OMB?

    No. The information collection requirements related to this action 
have already been approved by OMB pursuant to the Paperwork Reduction

[[Page 54648]]

Act (PRA), 44 U.S.C. 3501 et seq., under OMB Control Number 2070-0030 
(EPA ICR No. 0795). The public reporting burden for submitting an 
export notification to the agency is estimated to average 0.55 hour per 
response. As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means 
the total time, effort, or financial resources expended by persons to 
generate, maintain, retain, or disclose or provide information to or 
for a Federal agency. 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 OMB 
control number for this information collection appears above. In 
addition, the OMB control numbers for EPA's regulations, after initial 
display in the final rule, are listed in 40 CFR part 9.
    Send any comments on the Agency's need for this information, the 
accuracy of the provided burden estimate, and any suggested methods for 
minimizing respondent burden, including through the use of automated 
collection techniques, to the Director, OPPE Regulatory Information 
Division (2137), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Include the OMB control number in any 
correspondence, but do not submit export notification letters to this 
address.

D. Does this action impose any requirements on State, local, or tribal 
governments?

    No.
    1. Unfunded Mandates Reform Act of 1995
    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of certain regulatory actions on State, local, or tribal 
governments or the private sector, and to seek input from State, local, 
and tribal governments on certain regulatory actions. EPA has 
determined that this action does not contain a Federal mandate that may 
result in expenditures of $100 million or more for State, local, or 
tribal governments, in the aggregate, or the private sector, in any 1 
year. Therefore, this action is not subject to the requirements of 
sections 202 or 205 of UMRA. The requirements of sections 203 and 204 
of UMRA, which relate to regulatory requirements that might 
significantly or uniquely affect small governments and to regulatory 
proposals that contain a significant Federal intergovernmental mandate, 
respectively, also do not apply to this proposed rule. This is because 
the proposed rule would only affect the private sector, i.e., those 
companies that export or intend to export chemicals for which the 
submission of data is required under section 4 of TSCA.
    2. Executive Order 12875
    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's proposed rule does not create an unfunded Federal mandate 
on State, local, or tribal governments. The proposed rule does not 
impose any enforceable duties on these entities. Accordingly, the 
requirements of section 1(a) of Executive Order 12875 do not apply to 
this proposed rule.
    3. Executive Order 13084
    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's proposed rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This proposed action does not 
involve or impose any requirements that affect Indian tribes. 
Accordingly, the requirements of section 3(b) of Executive Order 13084 
do not apply to this proposed rule.

E. Does this action result in a significant impact on a substantial 
number of small entities?

    Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
the Agency has determined that this proposed rule would not result in a 
significant economic impact on a substantial number of small entities, 
and hereby certifies to that effect pursuant to section 605(b) of the 
RFA.
     The export regulations implementing section 12(b) of TSCA are 
found at 40 CFR part 707, subpart D. These regulations require only a 
one-time notification to EPA for each foreign country of export for 
each chemical for which data are required under section 4 of TSCA. In 
an analysis of the economic impacts of the July 27, 1993, amendment to 
the rules implementing section 12(b) of TSCA (58 FR 40238), EPA 
estimated that the one-time cost of preparing and submitting the TSCA 
section 12(b) notification was $62.60. See U.S. EPA, ``Economic 
Analysis in Support of the Final Rule to Amend Rule Promulgated Under 
TSCA Section 12(b),'' OPPT/ETD/RIB, June 1992, contained in the record 
for this rulemaking. Inflated through the last quarter of 1996 using 
the Consumer Price Index, the cost is estimated to be $69.56.
    Although data available to EPA regarding export shipments of DBEs 
are limited, an exporter would have to have annual revenues below 
$6,956 per chemical/country combination before the Agency would be 
concerned about the potential for substantive adverse impacts. EPA 
believes that it is reasonable to assume that few, if any, small 
exporters would have such small annual revenues per chemical/country 
combination. The Agency concludes that the export notification 
requirements will not have a significant impact on entities involved in 
exporting chemicals, regardless of whether the exporting entity is 
small or large.

[[Page 54649]]

F. Does this action involve a technical standard?

    No. This proposed rule does not involve any technical standards 
that would require Agency consideration of voluntary consensus 
standards pursuant to 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). Section 12(d) directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. The NTTAA requires EPA to provide Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards. EPA invites public comment on 
EPA's conclusion that this action does not require the consideration of 
voluntary consensus standards.

List of Subjects in 40 CFR Part 799

    Environmental protection, Chemicals, Exports, Hazardous substances, 
Health, Laboratories, Reporting and recordkeeping requirements.

    Dated: September 30, 1998.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 799--[AMENDED]

     1. The authority citation for part 799 would continue to read as 
follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.

    2. Section 799.5000 is amended by adding dimethyl succinate, 
dimethyl adipate, and dimethyl glutarate to the table in CAS number 
order to read as follows:


Sec. 799.5000  Testing consent orders for substances and mixtures 
withChemical Abstract Service Registry Numbers.

* * * * *

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                                         Substance or mixture
              CAS Number                         name                   Testing            FR Publication Date
----------------------------------------------------------------------------------------------------------------
*                    *                    *                    *                    *                    *
                                                              *
106-65-0                               Dimethyl succinate.....  Health effects.........  [date of final rule]
*                    *                    *                    *                    *                    *
                                                              *
627-93-0                               Dimethyl adipate.......  Health effects.........  [date of final rule]
*                    *                    *                    *                    *                    *
                                                              *
1119-40-0                              Dimethyl glutarate.....  Health effects.........  [date of final rule]
*                    *                    *                    *                    *                    *
                                                              *
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[FR Doc. 98-27386 Filed 10-9-98; 8:45 am]
BILLING CODE 6560-50-F