Toxic substances: Export notification requirements— Dimethyl adipate, dimethyl glutarate, and dimethyl succinate,

[Federal Register: October 13, 1998 (Volume 63, Number 197)]

[Proposed Rules]

[Page 54646-54649]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13oc98-34]

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.

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:

1. General Information

   1. 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

      ‹bullet›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.

   2. 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]]

   3. 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 filedonline at many Federal Depository Libraries.

   4. 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.

2. 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.

3. Background

   1. 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.

   2. 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.

4. Regulatory Assessment Requirements

   1. 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.

   2. 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).

   3. 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.

   4. 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.

   5. 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.

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   6. 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.

         * * * * *

         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] *

         *

         *

         *

         *

         * *

         * * * * *

         [FR Doc. 98-27386Filed10-9-98; 8:45 am]

         BILLING CODE 6560-50-F