[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: semeniuk.george@epa.gov.
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-Hotline@epa.gov.
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:
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Examples of Regulated
Category Entities
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Chemical exporters Persons who export
or intend to export DMA,
DMG, and/or DMS
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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:
oppt.ncic@epa.gov. 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
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* * * * * *
*
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
