[Federal Register Volume 64, Number 9 (Thursday, January 14, 1999)]
[Notices]
[Pages 2488-2490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-896]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-00257; FRL-6050-4]


Toxic Chemicals; Agency Information Collection Activities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 
et seq.), this notice announces that EPA is planning to submit the 
following Information Collection Requests (ICRs) to the Office of 
Management and Budget (OMB). Before submitting the ICRs to OMB for 
review and approval, EPA is soliciting comments on specific aspects of 
the information collections described in Unit I. and Unit II. of this 
document. The ICRs are: (1) A continuing ICR entitled ``Health and 
Safety Data Reporting, Submission of Lists and Copies of Health and 
Safety Studies,'' EPA ICR No. 0575.08, OMB No. 2070-0004, which relates 
to reporting requirements found at 40 CFR part 716; (2) a continuing 
ICR entitled ``Reporting and Recordkeeping Requirements for Allegations 
of Significant Adverse Reactions to Human Health or the Environment,'' 
EPA ICR No. 1031.06, OMB No. 2070-0017, which relates to reporting 
requirements found at 40 CFR part 717; and (3) a continuing ICR 
entitled ``Significant New Use Rules for Existing Chemicals,'' EPA ICR 
No. 1188.05, OMB No. 2070-0038, which relates to reporting requirements 
found at 40 CFR part 721. 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 are listed in 40 CFR part 9.

DATES: Written comments must be submitted on or before March 15, 1999.

ADDRESSES: Each comment must bear the respective docket control numbers 
and administrative record numbers as follows: Comments on ICR No. 
0575.08 should reference docket control number ``OPPTS-00258'' and 
administrative record number 202; comments on ICR No. 1031.06 should 
reference docket control number ``OPPTS-00259'' and administrative 
record number 203; and comments on ICR No. 1188.05 should reference 
docket control number ``OPPTS-00260'' and administrative record number 
204. All comments should be sent in triplicate to: OPPT Document 
Control Officer (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower, 
Washington, DC 20460.
    Comments and data may also be submitted electronically to: 
[email protected]. Follow the instructions under Unit III. of this 
document. No TSCA Confidential Business Information (CBI) should be 
submitted through e-mail.
    All comments that contain information claimed as CBI must be 
clearly marked as such. Three sanitized copies of any comments 
containing information claimed as CBI must also be submitted and will 
be placed in the public record for this document.

[[Page 2489]]

Persons submitting information on any portion of which they believe is 
entitled to treatment as CBI by EPA must assert a business 
confidentiality claim in accordance with 40 CFR 2.203(b) for each such 
portion. This claim must be made at the time that the information is 
submitted to EPA. If a submitter does not assert a confidentiality 
claim at the time of submission, EPA will consider this as a waiver of 
any confidentiality claim and the information may be made available to 
the public by EPA without further notice to the submitter.

FOR FURTHER INFORMATION CONTACT: For general information contact: Susan 
B. Hazen, 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: 
Frank Kover, Chemical Control Division (7405), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, Telephone: 202-260-8130, Fax: 202-260-1096, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

Electronic Availability:

Internet

    Electronic copies of the ICRs are available from the EPA Home Page 
at the Federal Register - Environmental Documents entry for this 
document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/).

Fax-on-Demand

    Using a faxphone call 202-401-0527 and select item 4062 for a copy 
of ICR No. 0575.08; select item 4063 for a copy of ICR No. 1031.06; or 
select item 4064 for a copy of ICR No. 1188.05.

I. Background

    Affected entities: Entities potentially affected by this action 
are, with respect to ICR No. 0575.08, ICR No. 1031.06, and ICR No. 
1188.05, those companies that manufacture, process, import, or 
distribute in commerce chemical substances or mixtures. For each 
collection of information addressed in this notice, EPA would like to 
solicit comments to:
    1. Evaluate whether the proposed collection of information is 
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 estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.

II. Information Collections

    EPA is seeking comments on the following three ICRs, as well as the 
Agency's intention to renew the corresponding OMB approvals.
    Title: Health and Safety Data Reporting, Submission of Lists and 
Copies of Health and Safety Studies.
    ICR numbers: EPA ICR No. 0575.08, OMB No. 2070-0004.
    Approval expiration date: April 30, 1999.
    Abstract: Section 8(d) of the Toxic Substances Control Act (TSCA) 
and 40 CFR part 716 requires manufacturers and processors of chemicals 
to submit lists and copies of health and safety studies relating to the 
health and/or environmental effects of certain chemical substances and 
mixtures. In order to comply with the reporting requirements of TSCA 
section 8(d), respondents must search their records to identify any 
health and safety studies in their possession, copy and process 
relevant studies, list studies that are currently in progress, and 
submit this information to EPA.
    EPA uses this information to construct a complete picture of the 
known effects of the chemicals in question, leading to determinations 
by EPA of whether additional testing of the chemicals is required. The 
information enables EPA to base its testing decisions on the most 
complete information available and to avoid demands for testing that 
may be duplicative. EPA will use information obtained via this 
collection to support its investigation of the risks posed by chemicals 
and, in particular, to support its decisions on whether to require 
industry to test chemicals under section 4 of TSCA.
    Responses to the collection of information are mandatory (see 40 
CFR part 716). 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.
    Burden statement: The burden to respondents for complying with this 
ICR is estimated to total 4,542 hours per year with an annual cost of 
$352,179. These totals are based on an average burden ranging between 
approximately 2 and 34 hours per response, depending upon the category 
of respondent, for an estimated 1,203 respondents making one or more 
responses annually. These estimates include 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.
    Title: Reporting and Recordkeeping Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment.
    ICR numbers: EPA ICR No. 1031.06, OMB No. 2070-0017.
    Approval expiration date: April 30, 1999.
    Abstract: TSCA section 8(c) requires companies that manufacture, 
process, or distribute chemicals to maintain records of significant 
adverse reactions to health or the environment alleged to have been 
caused by such chemicals. Since TSCA section 8(c) includes no automatic 
reporting provision, EPA can obtain and use the information contained 
in company files only by inspecting those files or requiring reporting 
of records that relate to specific substances of concern. Therefore, 
under certain conditions, and using the provisions found in 40 CFR part 
717, EPA may require companies to report such allegations to the 
Agency.
    EPA uses such information on a case-specific basis to corroborate 
suspected adverse health or environmental effects of chemicals already 
under review by EPA. The information is also useful to identify trends 
of adverse effects across the industry that may not be apparent to any 
one chemical company.
    Responses to the collection of information are mandatory (see 40 
CFR part 717). 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

[[Page 2490]]

with, the procedures in TSCA section 14 and 40 CFR part 2.
    Burden statement: The burden to respondents for complying with this 
ICR is estimated to total 30,279 hours at a cost of $2,510,537. These 
totals are based on an average burden ranging between approximately 
0.25 and 8 hours per response, depending upon the category of 
respondent, for an estimated 7,397 respondents making one or more 
responses annually. These estimates include 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.
    Title: Significant New Use Rules for Existing Chemicals.
    ICR numbers: EPA ICR No. 1188.05, OMB No. 2070-0038.
    Approval expiration date: April 30, 1999.
    Abstract: Section 5 of TSCA provides EPA with a regulatory 
mechanism to monitor and, if necessary, control significant new uses of 
chemical substances. Section 5 of TSCA authorizes EPA to determine by 
rule (a significant new use rule or SNUR), after considering all 
relevant factors, that a use of a chemical substance represents a 
significant new use. If EPA determines that a use of a chemical 
substance is a significant new use, section 5 of TSCA requires persons 
to submit a notice to EPA at least 90 days before they manufacture, 
import, or process the substance for that use.
    EPA uses the information obtained through this collection to 
evaluate the health and environmental effects of the significant new 
use. EPA may take regulatory actions under TSCA section 5, 6 or 7 to 
control the activities for which it has received a SNUR notice. These 
actions include orders to limit or prohibit the manufacture, 
importation, processing, distribution in commerce, use or disposal of 
chemical substances. If EPA does not take action, TSCA section 5 also 
requires EPA to publish a Federal Register notice explaining the 
reasons for not taking action.
    Responses to the collection of information are mandatory (see 40 
CFR part 721). 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.
    Burden statement: The burden to respondents for complying with this 
ICR is estimated to total 1,032 hours per year with an annual cost of 
$72,378. These totals are based on an average ranging between 
approximately 1 and 119 hours per response, depending upon the type of 
response, for an estimated 675 respondents making one or more responses 
annually (the great majority of respondents will experience a burden of 
1 hour per response; a very few respondents, estimated at three, will 
experience a burden of 119 hours per response). These estimates include 
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.

III. Public Record and Electronic Submissions

    The official record for this document, as well as the public 
version, has been established for this document under docket control 
number ``OPPTS-00257'' (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 12 noon to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located in the TSCA Nonconfidential 
Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comments and data 
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file 
format. All comments and data in electronic form addressing ICR No. 
0575.08 must be identified by docket control number ``OPPTS-00258'' and 
administrative record number 202. All comments and data in electronic 
form addressing ICR No. 1031.06 must be identified by docket control 
number ``OPPTS-00259'' and administrative record number 203. All 
comments and data in electronic form addressing ICR No. 1188.05 must be 
identified by docket control number ``OPPTS-00260'' and administrative 
record number 204. Electronic comments on this document may be filed 
online at many Federal Depository Libraries.

List of Subjects

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

    Dated: January 6, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-896 Filed 1-13-99; 8:45 am]
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