[Federal Register Volume 68, Number 240 (Monday, December 15, 2003)]
[Notices]
[Pages 69677-69680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30885]


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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: [email protected].
    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:[email protected].

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 [email protected], 
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]
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