[Federal Register: February 9, 2005 (Volume 70, Number 26)]
[Notices]
[Page 6857-6860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe05-54]
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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:
TSCA-Hotline@epa.gov.
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: brown.gerry@epa.gov.
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 oppt.ncic@epa.gov,
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]
BILLING CODE 6560-50-S