[Federal Register: December 15, 2003 (Volume 68, Number 240)]
[Notices]
[Page 69677-69680]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de03-46]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2003-0065; FRL-7335-8]
Pre-Manufacture Review Reporting and Exemption Requirements for
New Chemical Substances and Significant New Use Reporting Requirements
for Chemical Substances; Request for Comment on Renewal of Information
Collection Activities
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.) EPA is seeking public comment and information on
the following Information Collection Request (ICR): Pre-Manufacture
Review Reporting and Exemption Requirements for New Chemical Substances
and Significant New Use Reporting Requirements for Chemical Substances
(EPA ICR No. 0574.12, OMB Control No. 2070-0012). This ICR involves a
collection activity that is currently approved and scheduled to expire
on July 31, 2004. The information collected
[[Page 69678]]
under this ICR helps EPA evaluate the health and environmental effects
of new chemical substances before manufacture or importation of such
substances begin. The ICR describes the nature of the information
collection activity and its expected burden and costs. Before
submitting this ICR to the Office of Management and Budget (OMB) for
review and approval under the PRA, EPA is soliciting comments on
specific aspects of the collection.
DATES: Written comments, identified by the docket ID number OPPT-2003-
0065, must be received on or before February 13, 2004.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, 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: Jim Alwood, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8974; fax number: (202) 564-4745; e-mail address:alwood.jim@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture,
process or import chemical substances. Potentially affected entities
may include, but are not limited to:
[sbull] Petroleum and coal products manufacturing (NAICS 324),
e.g., Petroleum refineries, asphalt paving, roofing, saturated
materials manufacturing, asphalt shingle and coating materials
manufacturing, petroleum lubricating oil, and grease manufacturing.
[sbull] Chemical manufacturing (NAICS 325), e.g., Basic chemical
manufacturing, resin, synthetic rubber, artificial and synthetic fibers
and filaments manufacturing, paint, coating, adhesive manufacturing and
other chemical product, and preparation manufacturing.
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 in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether 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-2003-0065. 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/.
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 ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
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. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and to Whom Do I Submit the Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are
[[Page 69679]]
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments. If you wish to submit CBI or
information that is otherwise protected by statute, please follow the
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit
CBI or information protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPPT-2003-0065. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment. ii. E-mail. Comments may be sent by e-mail to oppt.ncic@epa.gov,
Attention: Docket ID Number OPPT-2003-0065. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2003-0065 The DCO is open from 8 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the DCO is
(202) 564-8930.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI 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 technical person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider when 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 collection activity.
7. Make sure to submit your comments by the deadline in this
notice.
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.
F. What Information is EPA Particularly Interested in?
Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits
comments and information to enable it to:
1. Evaluate whether the proposed collections of information are
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burdens
of the proposed collections of information.
3. Enhance the quality, utility, and clarity of the information to
be collected.
4. Minimize the burden of the collections of information on those
who are to respond, including through the use of appropriate automated
or electronic collection technologies or other forms of information
technology, e.g., permitting electronic submission of responses.
II. What Information Collection Activity or ICR Does this Action Apply
to?
EPA is seeking comments on the following ICR:
Title: Pre-Manufacture Review Reporting and Exemption Requirements
for New Chemical Substances and Significant New Use Reporting
Requirements for Chemical Substances.
ICR numbers: EPA ICR No. 0574.12, OMB Control No. 2070-0012.
ICR status: This ICR is currently scheduled to expire on July 31,
2004. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR,
[[Page 69680]]
after appearing in the Federal Register, are listed in 40 CFR part 9,
and included on the related collection instrument or form, if
applicable.
Abstract: Section 5 of the Toxic Substances Control Act (TSCA)
requires manufacturers and importers of new chemical substances to
submit to EPA notice of intent to manufacture or import a new chemical
substance 90 days before manufacture or import begins. EPA reviews the
information contained in the notice to evaluate the health and
environmental effects of the new chemical substance. On the basis of
the review, EPA may take further regulatory action under TSCA, if
warranted. If EPA takes no action within 90 days, the submitter is free
to manufacture or import the new chemical substance without
restriction.
TSCA section 5 also authorizes EPA to issue Significant New Use
Rules (SNURs). EPA uses this authority to take follow-up action on new
or existing chemicals that may present an unreasonable risk to human
health or the environment if used in a manner that may result in
different and/or higher exposures of a chemical to humans or the
environment. Once a use is determined to be a significant new use,
persons must submit a notice to EPA 90 days before beginning
manufacture, processing, or importation of a chemical substance for
that use. Such a notice allows EPA to receive and review information on
such a use and, if necessary, regulate the use before it occurs.
Finally, TSCA section 5 also permits applications for exemption
from section 5 review under certain circumstances. An applicant must
provide information sufficient for EPA to make a determination that the
circumstances in question qualify for an exemption. In granting an
exemption, EPA may impose appropriate restrictions.
Responses to the collection of information are mandatory (see 40
CFR parts 700, 720, 721, 723, and 725). Respondents may claim all or
part of a document confidential. EPA will disclose information that is
covered by a claim of confidentiality only to the extent permitted by,
and in accordance with, the procedures in TSCA section 14 and 40 CFR
part 2.
III. What are EPA's Burden and Cost Estimates for this ICR?
Under PRA, ``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. For this
collection it includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purposes
of collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
The ICR provides a detailed explanation of this estimate, which is
only briefly summarized in this notice. The annual public burden for
this collection of information is estimated to average 102.1 hours per
response and to require 3.4 hours of recordkeeping per response. The
following is a summary of the estimates taken from the ICR:
Respondents/affected entities: 443.
Estimated total number of potential respondents: Unknown.
Frequency of response: On occasion.
Estimated average number of responses for each respondent: 3.
Estimated total annual burden hours: 163,791 hours.
Estimated total annual burden costs: $34,348,733.
IV. Are There Changes in the Estimates from the Last Approval?
This request reflects a decrease of 62,756 hours (from 226,547
hours to 163,791 hours) in the total estimated respondent burden from
that currently in the OMB inventory. This decrease represents an
adjustment in the number of annual submissions to reflect EPA's
experiences since the most recent ICR. The decrease in the number of
submissions per year is largely associated with the polymer and other
exemptions implemented under the 1995 amendments.
V. What is the Next Step in the Process for this ICR?
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
FOR FURTHER INFORMATION CONTACT.
List of Subjects
Environmental protection, Reporting and recordkeeping requirements.
Dated: December 4, 2003.
William H. Sanders III,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
[FR Doc. 03-30885 Filed 12-12-03; 8:45 am]
BILLING CODE 6560-50-S