[Federal Register Volume 70, Number 8 (Wednesday, January 12, 2005)]
[Notices]
[Pages 2162-2164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-620]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2002-0067; FRL-7690-4]


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: 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 (http://www.epa.gov/oppt/tsca8e/).

FOR FURTHER INFORMATION CONTACT: 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: [email protected].
    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: 
[email protected].

SUPPLEMENTARY INFORMATION:

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

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substances 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 http://www.epa.gov/fedrgstr/. A complete, consolidated 
version of the TSCA section 8(e) Policy Statement and Guidance can be 
found on the EPA website at: http://www.epa.gov/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 http://www.epa.gov/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

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guidance. 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: http://www.epa.gov/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).

List of Subjects

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping.


    Dated: January 3, 2005.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. 05-620 Filed 1-11-05; 8:45 am]
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