TSCA Section 8(e) Reporting Guidance; Correction, Clarification of Applicability, and Announcement Regarding the Issuance Questions and Answers, 2162-2164 [05-620]
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Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
on disk or CD ROM, mark the outside
of the disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
CBI). Information so marked will not be
disclosed except in accordance with
procedures set forth in 40 CFR part 2.
In addition to one complete version of
the comment that includes any
information claimed as CBI, a copy of
the comment that does not contain the
information claimed as CBI must be
submitted for inclusion in the public
docket and EPA’s electronic public
docket. If you submit the copy that does
not contain CBI on disk or CD ROM,
mark the outside of the disk or CD ROM
clearly that it does not contain CBI.
Information not marked as CBI will be
included in the public docket and EPA’s
electronic public docket without prior
notice. If you have any questions about
CBI or the procedures for claiming CBI,
please consult the person listed under
FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare
My Comments for EPA?
You may find the following
suggestions helpful for preparing your
comments:
1. Explain your views as clearly as
possible.
2. Describe any assumptions that you
used.
3. Provide copies of any technical
information and/or data you used that
support your views.
4. If you estimate potential burden or
costs, explain how you arrived at the
estimate that you provide.
5. Provide specific examples to
illustrate your concerns.
6. Offer alternative ways to improve
the notice.
7. Make sure to submit your
comments by the deadline in this
document.
8. To ensure proper receipt by EPA,
be sure to identify the docket ID number
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
II. Background
In the Federal Register of December
22, 2004 (69 FR 76732) (FRL–7688–7),
EPA announced the issuance of EUP
524–EUP–96 to Monsanto Company,
800 N. Lindberg Blvd., St. Louis, MO
63167. Monsanto has requested to
further extend this EUP to March 1,
2006 and to amend it by allowing an
additional 3,023 acres to be planted.
Plantings are still to include the plantincorporated protectants ZMIR39 x
MON810 combined insecticidal trait
stacked corn hybrids along with
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ZMIR39 and MON810 corn hybrids;
Bacillus thuringiensis Cry3Bb1 protein
and the genetic material necessary for
its production (vector ZMIR39) in corn
(ZMIR39) and Bacillus thuringiensis
Cry1Ab delta-endotoxin and the genetic
material necessary for its production
(vector PV–ZMCT01) in corn (MON810)
for breeding and observation nursery,
inbred seed increase production, line
per se, hybrid yield, and herbicide
tolerance, insect efficacy, product
characterization and performance/
labeling, insect resistance management,
non-target organism and benefit, seed
treatment, swine growth and feed
efficiency, dairy cattle feed efficiency,
beef cattle growth and feed efficiency,
and cattle grazing feed efficiency trials.
The program is proposed for the States
of Alabama, California, Colorado,
Hawaii, Illinois, Indiana, Iowa, Kansas,
Kentucky, Maryland, Michigan,
Minnesota, Mississippi, Missouri,
Nebraska, New Mexico, New York,
North Carolina, North Dakota, Ohio,
Oklahoma, Pennsylvania, Puerto Rico,
South Dakota, Tennessee, Texas,
Virginia, Washinton, and Wisconsin.
III. What Action is the Agency Taking?
Following the review of the Monsanto
Company application and any
comments and data received in response
to this notice, EPA will decide whether
to issue or deny the EUP request for this
EUP program, and if issued, the
conditions under which it is to be
conducted. Any issuance of an EUP will
be announced in the Federal Register.
IV. What is the Agency’s Authority for
Taking this Action?
The Agency’s authority for taking this
action is under FIFRA section 5.
List of Subjects
Environmental protection,
Experimental use permits.
Dated: December 23, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
[FR Doc. 05–506 Filed 1–11–05; 8:45 am]
BILLING CODE 6560–50–S
PO 00000
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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 (https://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
Frm 00054
Fmt 4703
Sfmt 4703
E:\FR\FM\12JAN1.SGM
12JAN1
Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
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
VerDate jul<14>2003
17:37 Jan 11, 2005
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https://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: https://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 https://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
PO 00000
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Fmt 4703
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2163
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 pre1991 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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Federal Register / Vol. 70, No. 8 / Wednesday, January 12, 2005 / Notices
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: https://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).
the Farm Credit Administration in
McLean, Virginia, on January 13, 2005,
from 9 a.m. until such time as the Board
concludes its business.
FOR FURTHER INFORMATION CONTACT:
Jeanette C. Brinkley, Secretary to the
Farm Credit Administration Board,
(703) 883–4009, TTY (703) 883–4056.
ADDRESSES: Farm Credit
Administration, 1501 Farm Credit Drive,
McLean, Virginia 22102–5090.
SUPPLEMENTARY INFORMATION: This
meeting of the Board will be open to the
public (limited space available). In order
to increase the accessibility to Board
meetings, persons requiring assistance
should make arrangements in advance.
The matters to be considered at the
meeting are:
List of Subjects
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping.
Freeze on the Filing of Certain TV and
DTV Requests for Allotment or Service
Area Changes
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]
BILLING CODE 6560–50–S
FARM CREDIT ADMINISTRATION
Farm Credit Administration Board;
Regular Meeting; Sunshine Act
Farm Credit Administration.
Notice is hereby given,
pursuant to the Government in the
Sunshine Act (5 U.S.C. 552b(e)(3)), of
the regular meeting of the Farm Credit
Administration Board (Board).
DATE AND TIME: The regular meeting of
the Board will be held at the offices of
AGENCY:
SUMMARY:
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17:37 Jan 11, 2005
Jkt 205001
Open Session
A. Approval of Minutes
• December 9, 2004 (Open and Closed)
B. Reports
• Corporate Report
C. New Business—Other
• Fiscal Year 2004 Financial Audit
Dated: January 7, 2005.
Jeanette C. Brinkley,
Secretary, Farm Credit Administration Board.
[FR Doc. 05–684 Filed 1–7–05; 4:57 pm]
BILLING CODE 6705–01–P
FEDERAL COMMUNICATIONS
COMMISSION
[DA 04–2446]
Federal Communications
Commission.
ACTION: Notice.
AGENCY:
SUMMARY: This document announces an
immediate freeze on the filing of certain
requests by analog and digital television
broadcast stations for changes to
existing DTV and analog TV service
areas and channels. This freeze will
assist the Commission in the process of
implementing a channel election and
repacking process that will assign to
eligible television broadcasters a posttransition DTV channel in the core
television spectrum (i.e., channels 2–
51).
The Freeze became effective on
August 3, 2004.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC 20554.
DATES:
PO 00000
Frm 00056
Fmt 4703
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Kim
Matthews, Policy Division, Media
Bureau, Federal Communications
Commission, (202) 418–2120.
SUPPLEMENTARY INFORMATION: Beginning
immediately, and until further notice,
the Commission will not accept for
filing certain requests by analog and
digital television broadcast stations for
changes to existing DTV and analog TV
service areas and channels. Specifically,
until further notice, the Commission
will not accept for filing the following:
• Petitions for rulemaking to change
DTV channels within the DTV Table of
Allotments.
• Petitions for rulemaking for new
DTV allotment proceedings.
• Petitions for rulemaking to swap incore DTV and NTSC channels.
• Applications to change DTV
channel allotments among two or more
licensees.
• Petitions for rulemaking by
licensees/permittees to change NTSC
channels or communities of license.
• Television modification
applications that would increase a
station’s DTV service area in channels
2–51 in one or more directions beyond
the combined area resulting from the
station’s parameters as defined in the
following: (1) The DTV Table of
Allotments; (2) Commission
authorizations (license and/or
construction permit); and (3)
applications on file with the
Commission prior to release of the
freeze public notice; and television
modification applications that would
increase a station’s analog service area
in channels 2–51 in one or more
directions beyond the combined area
resulting from the station’s parameters
as defined in the following: (1)
Commission authorizations (license
and/or construction permit) and (2)
applications on file with the
Commission prior to release of the
freeze public notice. The Bureau may
consider, on a case by case basis and
consistent with the public interest,
amendments to those applications to,
for example, resolve interference with
other stations or pending applications or
to resolve mutual exclusivity with other
pending applications. In earlier public
notices, we have frozen maximization
applications for channels 52–59 and 60–
69.
• Class A station displacement
applications and applications for
coverage changes that would serve any
area that is not already served by that
Class A station’s authorized facilities.
As an exception to this freeze, on-air
Class A stations demonstrating that they
face imminent disruption of service may
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 70, Number 8 (Wednesday, January 12, 2005)]
[Notices]
[Pages 2162-2164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-620]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 (https://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 https://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: https://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 https://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
[[Page 2164]]
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: https://
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]
BILLING CODE 6560-50-S
