[Federal Register: January 12, 2005 (Volume 70, Number 8)]
[Notices]
[Page 2162-2164]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja05-99]
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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:
TSCA-Hotline@epa.gov.
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:
obryan.terry@epa.gov.
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
[[Page 2163]]
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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