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TSCA Section 8(e) Reporting Guidance; Correction, Clarification of Applicability, and Announcement Regarding the Issuance Questions and Answers

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Environmental Protection Agency (EPA).




EPA is correcting certain language that was inadvertently changed from the March 16, 1978, TSCA Section 8(e) Statement of Interpretation and Enforcement Policy; Notification of Substantial Risk (1978 TSCA Section 8(e) Policy Statement) when the Agency issued its TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance (2003 guidance document) on June 3, 2003. The 2003 guidance document clarified certain aspects of TSCA section 8(e) reporting guidance and included a re-publication of major portions of the Agency's 1978 TSCA Section 8(e) Policy Statement. This notice merely re-inserts, verbatim, certain language from the 1978 TSCA Section 8(e) Policy Statement into the June 3, 2003, guidance document. This notice also clarifies the applicability date of the June 3, 2003 guidance document, and announces the addition of questions and answers on the reportability of environmental releases to the Q&A section of the TSCA section 8(e) web page (​oppt/​tsca8e/​).

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For general information contact: Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 554-1404; e-mail address:

For technical information contact: Terry O'Bryan, Risk Assessment Division (7403M), Office Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-7656; e-mail address:

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I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you manufacture, process, import, or distribute in commerce chemical Start Printed Page 2163substances and mixtures. Potentially affected entities include, but are not limited to:

  • Chemical manufacturers, processors, and distributors (NAICS 325)
  • Petroleum refiners and distributors (NAICS 324)
  • Manufacturers of plastic parts and components (NAICS 325211)
  • Paints and coatings and adhesive manufacturing (NAICS 3255)
  • Cleaning compounds and similar products manufacturing (NAICS 3256)
  • Electronics manufacturing (NAICS 334 and 335)
  • Automobiles manufacturing (NAICS 3361)
  • Aircraft manufacturing (NAICS 336411)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed could also be affected. The North American Industry Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPPT-2002-0067. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is (202) 566-1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is (202) 566-0280.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at​fedrgstr/​. A complete, consolidated version of the TSCA section 8(e) Policy Statement and Guidance can be found on the EPA website at:​oppt/​tsca8e/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at​edocket/​ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket identification number.

II. Why are these Corrections Necessary?

These corrections are necessary to maintain the accuracy of the 1978 TSCA Section 8(e) Policy Statement (43 FR 11110) where certain changes appearing in the 2003 guidance document (68 FR 33129) (FRL-7287-4) were made in error. As noted in the June 3, 2003, Federal Register notice, the 2003 guidance document contained earlier guidance issued on TSCA section 8(e) that had not been changed and that was being reprinted for the convenience of all interested persons. In the affected sections covered in Unit III. of this document, the original language of the 1978 TSCA Section 8(e) Policy Statement should have been retained. This notice re-inserts original language from the 1978 TSCA Section 8(e) Policy Statement into the 2003 guidance document as shown in Unit III. of this document.

III. Specific Changes to the 2003 Guidance Document

In the 2003 guidance document, Unit VIII. entitled Republication of TSCA Section 8(e) Policy Statement and Guidance, the second paragraph of Part V. entitled What Constitutes Substantial Risk is removed and the following language from the 1978 TSCA Section 8(e) Policy Statement is added in its place:

Note that: (i) The effects outlined below should not be reported if the respondent has actual knowledge that the Administrator is already informed of them. (ii) Information respecting these effects can be obtained either directly, by observation of their occurrence, or inferred from designed studies as discussed in Part VI. Nature and Sources of Information Which “Reasonably Supports Conclusion” of Substantial Risk.

Also in Unit VIII. of the 2003 guidance document, Part VIII. entitled Information First Received by a Person Prior to the Effective Date of TSCA, paragraph (a) is removed and the following language from the 1978 TSCA Section 8(e) Policy Statement is added in its place:

(a) Any information reviewed after January 1, 1977, including not only written reports, memoranda and other documents examined after January 1, 1977, but also information referred to in discussions and conferences in which the person participated after January 1, 1977;

All other text contained in the June 3, 2003 Federal Register notice remains as stated therein.

IV. Applicability Date for the June 3, 2003 Guidance Document

In addition to the corrections discussed herein, this notice also clarifies the effective and applicability date of the 2003 TSCA Section 8(e) Policy Clarification and Reporting Guidance. The June 3, 2003 Federal Register notice did not include a specific statement regarding the effective date. Thus, by standard Agency practice, this Reporting Guidance became effective and applicable on the publication date.

The best reading of the Guidance is that it is effective upon publication. For instance, the summary statement of the notice describes it as “finalizing revisions” to the earlier policy statement, and “republishing the policy statement...both those portions of the policy statement that are revised and those portions that are not affected by any revisions.” (68 FR 33129 (emphases added)). Unit II.A. of the notice is entitled What Action is the Agency Taking?, and that unit explains that, by the notice, “[t]he Agency is revising and clarifying” its earlier policy statement. (68 FR 33130). There are several other statements in the present or present perfect tense that are consistent with the guidance being in effect upon issuance.

Under the auspices of the Agency's TSCA Section 8(e) Compliance Audit Program (“CAP”), a one-time enforcement initiative that took place between 1991 and 1996 regarding pre-1991 TSCA section 8(e) reporting requirements, the Agency had announced that, “EPA . . . intends to publish a question and answer document to illustrate application of the Start Printed Page 2164guidance. The final revised guidance will not be effective prior to EPA's publication of the question and answer document.” (See Revised Addendum to the CAP agreement conveyed to the CAP participants via a May 15, 1996 letter from the Office of Enforcement and Compliance Assurance.) This statement of intent was similar to proposals contained in the March 9, 1995 proposed TSCA section 8(e) Guidance which was the subject of a notice of availability published in the Federal Register of March 20, 1995 (60 FR 14756) (FRL-4937-6).

The June 3, 2003 Federal Register notice discusses the CAP in several places as part of the history of the development of the revised guidance. (See, e.g., 68 FR 33131, Unit II.C.). The notice also mentions the planned question and answer document (68 FR 33133). Yet, the June 3, 2003 notice never linked the effective date of the Reporting Guidance to the publication of a question and answer document. Rather, as mentioned in this unit, the best reading of the notice is that the Guidance was effective and applicable upon publication.

The Agency has now made a question and answer document available. It can be found on the OPPT's TSCA section 8(e) internet site:​oppt/​tsca8e/​.

EPA hopes and expects that the guidance has been, and will continue to be, useful to manufacturers (including importers), processors, and distributors of chemical substances and mixtures in fulfilling their responsibilities under TSCA section 8(e).

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List of Subjects

  • Environmental protection
  • Chemicals
  • Hazardous substances
  • Reporting and recordkeeping
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Dated: January 3, 2005.

Susan B. Hazen,

Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances.

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[FR Doc. 05-620 Filed 1-11-05; 8:45 am]