[Federal Register Volume 64, Number 150 (Thursday, August 5, 1999)]
[Notices]
[Pages 42692-42695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20205]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-42190B; FRL-6090-6]
Dibasic Esters; Final Enforceable Consent Agreement and Testing
Consent Order
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Under section 4 of the Toxic Substances Control Act (TSCA),
EPA has issued a testing consent order (Order) that incorporates an
enforceable consent agreement (ECA) with the Aceto Corporation, E.I. du
Pont de Nemours and Company, and Solutia Inc. (the ``Companies''). The
Companies have agreed to perform toxicity and dermal penetration rate
testing on 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), known collectively as dibasic esters (DBEs). This
notice announces the ECA and Order for DBEs and summarizes the terms of
the ECA.
DATES: The effective date of the ECA and Order is August 5, 1999.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Christine M. Augustyniak, Associate Director, Environmental Assistance
Division (7408), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone numbers: (202) 554-1404 and TDD: (202) 554-0551; e-mail
address: TSCA-Hotline@epa.gov.
For technical information contact: George Semeniuk, Project
Manager,
[[Page 42693]]
Chemical Control Division (7405), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC
20460; telephone number: (202) 260-2134; fax number: (202) 260-8168; e-
mail address: semeniuk.george@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Notice Apply To Me?
The ECA and Order announced in this notice only affect those
companies that signed the ECA for DBEs: the Aceto Corporation, E.I. du
Pont de Nemours and Company, and Solutia Inc. However, as a result of
the ECA and Order, EPA has initiated a rulemaking under TSCA section
12(b)(1) which, when finalized, will require all persons who export or
intend to export DBEs to comply with the Agency's export notification
regulations at 40 CFR part 707, subpart D.
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/.
On the Home Page, select ``Laws and Regulations'' and then look up the
entry for this document under ``Federal Register--Environmental
Documents'' (http://www.epa.gov/fedrgstr/EPA-TOX/1999/). You can also
go directly to the Federal Register listings at http://www.epa.gov/
fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-42190B. 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 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 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 is (202) 260-7099.
II. Background
A. What Are DBEs?
DBEs are component chemicals of solvent mixtures used in paint
stripping formulations that are sold to the general public. Consumers
can be significantly exposed to DBEs during use of these formulations.
Three chemicals make up the class of chemicals known as DBEs: Dimethyl
adipate (DMA), dimethyl glutarate (DMG), and dimethyl succinate (DMS).
The Chemical Abstract Service (CAS) registry number for DMA is 627-93-
0; for DMG, 1119-40-0; and for DMS, 106-65-0.
B. Why Is EPA Requiring Health Effects Testing On DBEs?
The potential for consumers to be exposed significantly while
using DBE paint stripping formulations, a reported adverse human
effect--blurred vision--that resulted from the use of DBE paint
strippers, and the results of limited toxicity testing of DBEs on rats
has formed the foundation for the Agency's concern for the potential
health risk that may be posed to consumers by DBE paint strippers.
III. ECA Development and Conclusion
A. How Is EPA Going To Obtain Health Effects Testing On DBEs?
EPA uses ECAs to accomplish testing where a consensus exists among
EPA, affected manufacturers and/or processors, and interested members
of the public concerning the need for and scope of testing (40 CFR
790.1(c)). In the March 22, 1995, Federal Register (see VI.A.2.a. of
this document), EPA invited manufacturers and processors of DBEs that
are used in paint strippers to develop and submit to EPA specific
toxicity testing proposals for DBEs for the purpose of negotiating an
ECA to conduct testing under Section 4 of TSCA.
The procedures for ECA negotiations are described at 40 CFR
790.22(b).
In response to EPA's request for proposals for ECAs, the Dibasic
Esters Group (the DBE Group) submitted a proposal for a testing program
on August 7, 1995 (Ref. 1). EPA responded to the DBE Group in a letter
dated March 6, 1996, noting that while their proposal had potential
merit and would expand the knowledge base of toxicity testing results
on DBEs, the proposal did not constitute an adequate basis for
proceeding with negotiation of an ECA (Ref. 2). EPA encouraged the DBE
Group to consider EPA's comments on their proposal and submit a revised
proposal. On October 22, 1996, the DBE Group submitted a revised
testing proposal (Ref. 3). The Agency concluded that the revised
proposal offered sufficient merit to proceed with ECA negotiations.
Consequently, EPA published a document soliciting interested parties to
monitor or participate in these negotiations (see VI.A.2.b. of this
document).
EPA held a public meeting to negotiate an ECA for DBEs on January
29, 1997. Representatives of the Companies and other interested parties
attended this meeting. The participants reached partial consensus on
the testing to be required under the ECA at this meeting (Ref. 4) and
complete consensus during a teleconference held on June 23, 1998 (Ref.
5). The Agency, the Companies, and an interested party participated in
the telephone conference. On February 22, 1999, EPA received the ECA
signed by the Companies. On July 28, 1999, EPA signed the ECA and
accompanying Order.
B. What Testing Does The ECA For DBEs Require?
This ECA requires toxicity testing by inhalation and dermal
exposure and dermal penetration rate testing, as described in this unit
and in Table 1 of this unit. This testing will allow EPA to
characterize the potential hazards resulting from exposure to DBEs and
to determine if additional toxicity testing is needed. Table 1 of this
unit sets forth the required testing, test standards, and reporting
requirements under the ECA for DBEs.
The testing program has three segments as follows: Initial Base
Toxicity Testing; Program Review Testing; and, if deemed necessary
following a Program Review, In Vivo Dermal Penetration Rate Testing.
For more information about the testing that will be conducted under the
ECA, copies of the ECA are available from sources described in Unit
I.B. of this document.
Testing shall be conducted in accordance with the Test Standards
listed in Table 1 of this unit.
[[Page 42694]]
Table 1.--Required Testing, Test Standards, and Reporting Requirements for DEBs
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Test Standard (40 CFR
Description of Test citation and/or study Deadline for final Interim reports
protocol) report (months) required (number)
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90-day Subchronic Inhalation Toxicity Protocol (based on 16\1\ 2\2\
Study with examination of special 799.9346, 799.9380,
endpoints (in rats) [for each DBE; 799.9620, and
dose response determined using DMG] incorporating a cell
proliferation study)
Dermal (14-day) Toxicity Study (in Protocol 12\1\ 1\2\
rats) [for each DBE and for a 3:1:1
mixture of DMG, DMA, and DMS,
respectively]
Mutagenicity: in vivo rat bone Protocol (based on 16\1\ 2\2\
micronucleus assay (via inhalation) 799.9539)
[for DMG and DMA]
Mutagenicity: gene mutations in Protocol (based on 10\1\ 1\2\
hamster ovary [for DMG] 799.9530)
Developmental Toxicity (in rabbits Protocol (based on 12\3\ 1\4\
via inhalation) [for one DBE, 799.9370)
selected by the EPA initial review
process) after completion of
Mutagenicity, 90-day Subchronic
Inhalation Toxicity and 14-day
Dermal Toxicity studies]
In Vitro Dermal Penetration Rate Protocol based on draft 12\3\ 1\4\
Study [for DBEs or DBE mixtures, OECD Guideline for In
selected by the EPA initial review Vitro Dermal
process] Penetration
In Vivo Dermal Penetration Rate Study 870.7485 12\5\ 1\6\
[for DBEs or DBE mixtures, selected
by the EPA Program Review process]
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\1\ Number of months following the effective date of the Order.
\2\ Interim reports are required every 6 months from the effective date of the ECA, unless otherwise noted,
until the final report is submitted. This number indicates the number of interim reports required for each
test based on the deadline set forth in the preceding column.
\3\ Number of months beginning 60 days after the date of the EPA letter containing the decisions resulting from
EPA's Initial Review (see VI.B. of the ECA).
\4\ Interim reports are required every 6 months beginning 60 days after the date of the EPA letter containing
decisions of the initial review, until the final report is submitted. This column shows the number of interim
reports required for each test based on the deadlines set forth in the preceding column.
\5\ Number of months beginning 60 days after the date of the EPA letter containing the decisions of the Program
Review for in vivo testing, if needed (see VI.D. of the ECA).
\6\ Interim reports are required every 6 months beginning 60 days after the date of the EPA letter containing
decisions of the program review, until the final report is submitted. This column shows the number of interim
reports required for the test based on the deadline set forth in the preceding column.
C. What Are The Uses For The Test Data For DBEs?
EPA would use the data obtained from testing to obtain a more
complete toxicity profile of DBEs. Such a profile will be used in
comparing the hazards of paint strippers based on DBEs to those of
consumer paint strippers that are based on methylene chloride, N-
methylpyrrolidone, or other common paint stripping solvents.
D. What If EPA Should Require Additional Toxicity Testing On DBEs?
If EPA decides in the future that it requires additional toxicity
data on DBEs, the Agency will initiate a separate action.
IV. Other Impacts Of The ECA For DBEs
The issuance of the ECA and Order under TSCA section 4 subjects the
Companies that signed the ECA to export notification requirements under
TSCA section 12(b)(1), as set forth at 40 CFR part 707, subpart D, if
they export or intend to export any of the three DBEs.
On October 13, 1998, in the Federal Register (63 FR 54646, October
13, 1998) (FRL-6029-8), EPA proposed to amend 40 CFR 799.5000 by adding
DMA, DMG, and DMS to the list of chemicals subject to testing consent
orders. The listing of a chemical substance at 40 CFR 799.5000 serves
as notification to all persons who export or intend to export any of
these three chemical substances that:
1. The chemical substances are the subject of an ECA and Order;
and
2. EPA's export notification regulations at 40 CFR part 707,
subpart D, apply to those exporters who have signed the ECA, as well as
those exporters who have not signed the ECA (40 CFR 799.19).
When a final rule based on the October 13, 1998, proposed rule is
published in the Federal Register, all persons who export or who intend
to export any of the DBEs will be subject to export notification
requirements.
V. Paperwork Reduction Act
The ECA and Order announced in this notice do not contain any
information collection requirements that require additional approval by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq. The information collection
requirements related to test rules and ECAs issued under TSCA section 4
have already been approved by OMB under OMB control number 2070-0033
(EPA ICR No. 1139). The one-time public burden for this collection of
information is estimated to be approximately 5,407 hours total. Under
the PRA, ``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. For this
collection it includes the time needed to review instructions; complete
and review the collection of information; and transmit or otherwise
disclose the information. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. The OMB
control numbers for EPA's regulations, after initial display in the
final rule, are listed in 40 CFR part 9. EPA will issue a final rule
related to export notification requirements for DBEs. That rule will
amend the listing at 40 CFR part 799, as well as the table at 40 CFR
part 9.
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VI. Public Record
A. Supporting Documentation
The record for this proceeding contains the basic information
considered in developing this ECA and Order and includes the following
information.
1. Testing Consent Order for Dibasic Esters, with incorporated
Enforceable Consent Agreement and associated testing protocols attached
as appendices.
2. Federal Register notices pertaining to this notice, the Testing
Consent Order and the Enforceable Consent Agreement, consisting of:
a. Notice of Solicitation of Testing Proposals for Negotiation of
TSCA Section 4 Enforceable Consent Agreements (60 FR 15143, March 22,
1995) (FRL-4943-6).
b. Notice of Public Meeting; Dibasic Esters--Paint Stripper
Chemicals (61 FR 67332, December 20, 1996) (FRL-5578-9).
3. Communications consisting of:
a. Written letters.
b. Meeting and teleconference summaries.
4. Reports--published and unpublished factual materials.
B. References
1. Dibasic Esters Group. Letter from Jorge C. Olguin to Charles M.
Auer, EPA, Re: Solicitation of TSCA Section 4 Consent Agreements for
Dibasic Esters, with attachment entitled ``Toxicity Literature Reviews
From the DuPont Haskell Laboratory.'' Washington, DC. (August 7, 1995).
2. U.S. Environmental Protection Agency (USEPA). Letter from
Charles M. Auer to Jorge C. Olguin, Dibasic Esters Group Re: toxicity
testing proposal submitted by Dibasic Esters Group. Washington, DC.
(March 6, 1996).
3. Dibasic Esters Group. Letter from Richard E. Opatick to Charles
M. Auer, EPA, Re: Data Development on Dibasic Esters. Washington, DC.
(October 22, 1996).
4. USEPA. Summary of EPA Public Meeting on DBEs Enforceable Consent
Agreement. Washington, DC. (January 29, 1997).
5. USEPA. Summary of Teleconference on DBEs Enforceable Consent
Agreement. Washington, DC. (June 23, 1998).
List of Subjects
Environmental protection, Hazardous chemicals.
Dated: July 28, 1999.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 99-20205 Filed 8-4-99; 8:45 am]
BILLING CODE 6560-50-F
