[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)]
[Notices]
[Pages 49484-49486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23711]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-00277; FRL-6096-4]


Pre-Manufacture Reporting and Exemption Requirements; Request for 
Comments on Proposed Renewal Information Collection

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. 0574.11, OMB No. 2070-0012). This ICR involves a 
collection activity that is currently approved and scheduled to expire 
on December 31, 1999. 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 control number 
``OPPTS-00277'' and administrative record number 215, must be received 
on or before November 12, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION'' section of 
this notice.
FOR FURTHER INFORMATION CONTACT: For general information contact: 
Christine M. Augustyniak, Associate Director, Environmental Assistance 
Division (7408), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
Telephone: 202-554-1404; TDD: 202-554-0551; e-mail: TSCA-
H[email protected]. For technical information contact: Jim Alwood, 
Chemical Control Division (7405), Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460, Telephone: 202-260-1857; Fax: 202-260-8168; e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

I. Does This Notice Apply to Me?

    You may be potentially affected by this notice if you manufacture 
or import new chemical substances, as defined by the Toxic Substances 
Control Act (TSCA), or manufacture, process, or import a chemical 
substance for a use that has been determined a significant new use, as 
defined by TSCA. Potentially affected categories and entities may 
include, but are not limited to the following:


------------------------------------------------------------------------
                                                 Standard Industrial
             Type of Business                 Classification (SIC) Code
------------------------------------------------------------------------
Chemical manufacturing                      28
Petroleum refining                          29
Photographic equipment                      386
------------------------------------------------------------------------

    This table 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 table could also be 
affected. To determine whether you or your business is affected by this 
action, you should carefully examine the applicability provisions at 40 
CFR part 720, Subpart B, 40 CFR part 721, Subparts A and C, 40 CFR part 
723, Subpart B, and 40 CFR part 725, Subparts A, B, D, E, F, G, and L. 
If you have any questions regarding the applicability of this action to 
a particular entity, consult the technical person listed in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

[[Page 49485]]

II. How Can I Get Additional Information or Copies of This Document 
or Other Support Documents?

A. Electronic Availability

    Electronic copies of this ICR are available from the EPA website at 
the ``Federal Register-Environmental Documents'' entry for this 
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/). 
You can follow the menu to find this Federal Register notice using the 
publication date or the Federal Register citation for this notice.

B. Fax-on-Demand

    You may request to receive a faxed copy of the ICR by using a 
faxphone to call 202-401-0527 and selecting item 4071. You may also 
follow the automated menu.

C. In Person or By Phone

    If you have any questions or need additional information about this 
notice or the ICR referenced, please contact the person identified in 
the ``FOR FURTHER INFORMATION CONTACT'' section.
    In addition, the official record for this notice, including the 
public version, has been established under docket control number 
``OPPTS-00277'' (including comments and data submitted electronically 
as described below). A public version of this record, including 
printed, paper versions of any electronic comments, which does not 
include any information claimed as Confidential Business Information 
(CBI), is available for inspection in the TSCA Nonconfidential 
Information Center, Rm. NE B-607, 401 M St., SW., Washington, DC. The 
Center is open from 12 noon to 4 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the Center is 202-260-7099.

III. How Can I Respond to This Notice?

A. How and to Whom Do I Submit the Comments?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number ``OPPTS-00277'' and administrative record number 215 in your 
correspondence.
    1. By mail. Submit written comments to: Document Control Office 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: Document 
Control Office in Rm. G-099, Waterside Mall, 401 M St., SW., 
Washington, DC, Telephone: 202-260-7093.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: [email protected]. Please note that you should not submit 
any information electronically that you consider to be CBI. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comment and data will also be 
accepted on standard computer disks in WordPerfect 5.1/6.1 or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket control number ``OPPTS-00277'' and 
administrative record number 215. Electronic comments on this notice 
may also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI Information That I Want To Submit To the 
Agency?

    You may claim information that you submit in response to this 
notice as CBI by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the comment that does 
not contain CBI must also be submitted for inclusion in the public 
record. Information not marked confidential will be included in the 
public docket by EPA without prior notice. If you have any questions 
about CBI or the procedures for claiming CBI, please consult with the 
technical person, listed in the ``FOR FURTHER INFORMATION CONTACT'' 
section.

C. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(a) of the 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.

D. What Should I Consider When I Prepare My Comments for EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we haven't considered, the potential impacts of 
the various options (including possible unintended consequences), and 
any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
     Explain your views as clearly as possible.
     Describe any assumptions that you used.
     Provide solid technical information and/or data to support 
your views.
     If you estimate potential burden or costs, explain how you 
arrived at the estimate.
     Provide specific examples to illustrate your concerns.
     Offer alternative ways to improve the collection activity.
     Make sure to submit your comments by the deadline in this 
notice.
     At the beginning of your comments (e.g., as part of the 
``Subject'' heading), be sure to properly identify the document on 
which you are commenting. You can do this by providing the docket 
control number assigned to the notice, along with the name, date, and 
Federal Register citation, or by using the appropriate EPA or OMB ICR 
number.

IV. To What Information Collection Activity or ICR Does This Notice 
Apply?

    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. 0574.11, OMB No. 2070-0012.
    ICR status: This ICR is currently scheduled to expire on December 
31, 1999. 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 
information collections appear on the collection instruments or 
instructions, in the Federal Register notices for related rulemakings 
and ICR notices, and, if the collection is contained in a regulation, 
in a table of OMB approval numbers in 40 CFR part 9.
    Abstract: TSCA section 5 requires manufacturers and importers of 
new

[[Page 49486]]

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 720, 721, and 723). Respondents may claim all or part of a 
notice 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.

V. What Are EPA's Burden and Cost Estimates for This ICR?

    Under the 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 101.5 hours per 
response. The following is a summary of the estimates taken from the 
ICR:
    Respondents/affected entities: Entities potentially affected by 
this action are manufacturers or importers of new chemical substances, 
as defined by the TSCA, or manufacturers, processors, or importers of a 
chemical substance for a use that has been determined a significant new 
use, as defined by TSCA.
    Estimated total number of potential respondents: 432.
    Frequency of response: On occasion.
    Estimated total/average number of responses for each respondent: 5-
6 (average).
    Estimated total annual burden hours: 241,611 hours.
    Estimated total annual burden costs: $31.665 million.

VI. Are There Changes in the Estimates From the Last Approval?

    There is no change in burden from that indicated in the information 
collection most recently approved by OMB.

VII. 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 person listed in the ``FOR 
FURTHER INFORMATION CONTACT'' section.

List of Subjects

    Environmental protection, Information collection requests, 
Reporting and recordkeeping requirements.

    Dated: September 2, 1999.

Susan H. Wayland,

Deputy Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-23711 Filed 9-10-99; 8:45 am]
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