[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-H[email protected].
    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: [email protected].

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.

[[Page 42695]]

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