[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Pages 6857-6860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2510]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2005-0003; FRL-7697-5]


Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment (TSCA 
section 8(c)); 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 on the following 
Information Collection Request (ICR): Recordkeeping and Reporting 
Requirements for Allegations of Significant Adverse Reactions to Human 
Health or the Environment (Toxic Substances Control Act (TSCA) section 
8(c)) (EPA ICR No. 1031.08, OMB Control No. 2070-0017). This ICR 
involves a collection activity that is currently approved and scheduled 
to expire on December 31, 2005. The information collected under this 
ICR relates to requirements under TSCA section 8(c) that companies that 
manufacture, process, or distribute in commerce any chemical substance 
or mixture maintain records of significant adverse reactions to health 
or the environment alleged to have been caused by such substance or 
mixture. 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.

[[Page 6858]]


DATES: Written comments, identified by the docket identification (ID) 
number OPPT-2005-0003, must be received on or before April 11, 2005.

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: 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: [email protected].
    For technical information contact: Gerry Brown, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8086; fax 
number: (202) 564-4765; 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 are a company 
that manufactures, processes, imports, or distributes in commerce 
chemical substances or mixtures. Potentially affected entities may 
include, but are not limited to:
     Chemical manufacturing (NAICS 325), e.g., basic chemical 
manufacturing; resin, synthetic rubber and artificial and synthetic 
fibers and filaments manufacturing; pesticide, fertilizer, and other 
agricultural chemical manufacturing; paint, coating, and adhesive 
manufacturing; soap, cleaning compound, and toilet preparation 
manufacturing etc.
     Petroleum refineries (NAICS 32411), e.g., crude oil 
refining, diesel fuels manufacturing, fuel oils manufacturing, jet fuel 
manufacturing, kerosene manufacturing, and petroleum distillation etc.
    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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR 717.5. 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 ID number OPPT-2005-0003. 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 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

[[Page 6859]]

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-2005-0003. 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-2005-0003. 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-2005-0003. 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: Recordkeeping and Reporting Requirements for Allegations of 
Significant Adverse Reactions to Human Health or the Environment (TSCA 
section 8(c)).
    ICR numbers: EPA ICR No. 1031.08, OMB Control No. 2070-0017.
    ICR status: This ICR is currently scheduled to expire on December 
31, 2005. 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, after appearing in the Federal 
Register, are listed in 40 CFR part 9, and included on the related 
collection instrument or form, if applicable.

[[Page 6860]]

    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 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 
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 range between 0.25 hour 
and 8.0 hours per response. The following is a summary of the estimates 
taken from the ICR:
    Respondents/affected entities: Companies that manufacture, process, 
import, or distribute in commerce chemical substances or mixtures.
    Estimated total number of potential respondents: 13,445.
    Frequency of response: On occasion.
    Estimated total/average number of responses for each respondent: 1.
    Estimated total annual burden hours: 24,548 hours.
    Estimated total annual burden costs: $1,232,417.

IV. Are There Changes in the Estimates from the Last Approval?

    There is a decrease of 5,391 hours (from 29,939 hours to 24,548 
hours) in the total estimated respondent burden compared with that 
identified in the ICR most recently approved by OMB. This decrease is 
based on several factors. Most importantly, while the number of firms 
rose since the last ICR (12,287 to 13,445), the number of employees 
fell (from 1,000,000+ to 909,562). Since the allegation rate is based 
on the number of employees, this results in a decrease in total 
allegations (7,397 to 6,050), and thus a reduction in burden. There is 
also a small reduction in burden associated with reviewing Federal 
Register notices. Based on experience over the life of the rule, the 
average annual number of notices the Agency is expected to issue fell 
from an estimated 0.11 in the most recent ICR to 0.1 notice per year 
estimated in this renewal. An additional small reduction is 
attributable to reduced industry reporting requirements, which have 
fallen from an estimated 1.75 reports per year (31 reports total/18 
years of the rule), to 1.5 reports per year, over the 21 years of the 
rule (31 reports/21 years).

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: February 1, 2005.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. 05-2510 Filed 2-8-05; 8:45 am]
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