[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Test Standard (40 CFR Description of Test citation and/or study Deadline for final Interim reports protocol) report (months) required (number) ---------------------------------------------------------------------------------------------------------------- 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] ---------------------------------------------------------------------------------------------------------------- \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