[Federal Register: March 25, 2004 (Volume 69, Number 58)]
[Notices]
[Page 15326-15328]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr04-65]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7640-2]
Notice of Availability of and Opportunity To Provide Comment on
Issues in the Staff Paper: An Examination of EPA Risk Assessment
Principles and Practices
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability and opportunity to comment.
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SUMMARY: Today, the EPA is announcing the availability of and an
opportunity to comment on issues in an EPA staff paper titled ``An
Examination of EPA Risk Assessment Principles and Practices.''
The paper is a product of an EPA staff review of how risk
assessment is conducted at EPA. It also presents staff recommendations
for EPA and interested parties to consider how EPA can strengthen and,
where appropriate, improve its risk assessment practices. The EPA
Science Advisor and other senior EPA officials requested this review to
further the discussion and examination of some broad questions about
risk assessment. The staff paper also discusses public comments
relevant to EPA that were submitted to the Office of Management and
Budget (OMB) in response to OMB's request for public comment on risk
assessment procedures in the Federal government (68 FR 5492-5527,
February 3, 2003). EPA assembled a group of risk assessment
professionals from across EPA to examine EPA's risk assessment
principles and practices, and to prepare this paper. This paper does
not represent official EPA policy.
The staff paper will not be revised further. EPA is releasing the
staff paper as the first step in a multi-step process by which EPA
intends to engage interested parties in a dialogue about risk
assessment principles and practices to improve the practice of risk
assessment. Accordingly, EPA is requesting public comment on the risk
assessment principles and practices described in the paper with the
objective of identifying particular issues for future dialogue. Future
dialogue on particular issues may come, for example, in discussions
under the auspices of EPA's Science Advisory Board, other consultative
groups, and professional societies with a focus on risk assessment and
with states, non-governmental organizations, and tribal groups. EPA is
interested in suggestions for other avenues for dialogue as well.
DATES: Comments must be received by June 23, 2004.
ADDRESSES:
Document Availability
The staff paper, ``An Examination of EPA Risk Assessment Principles
and Practices,'' is available via the Internet from http://www.epa.gov/osa
.
Submitting Comments
Comments may be submitted electronically, by mail, or through hand
delivery/courier. Follow the detailed instructions as provided in Unit
II.A. of the SUPPLEMENTARY INFORMATION section.
Viewing Public Comments
Comments may be viewed electronically. Follow the detailed
instructions as provided in Unit II.B. of the SUPPLEMENTARY INFORMATION
section.
FOR FURTHER INFORMATION CONTACT: For information only, contact Dr.
Kerry Dearfield, Office of the Science Advisor (8105R), U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, telephone 202-564-4499, or send electronic mail
inquiries to science.advisor@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background Information
The staff paper, ``An Examination of EPA Risk Assessment Principles
and
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Practices,'' represents an effort by EPA to examine how risk assessment
is conducted at EPA. The staff paper presents the perspectives of EPA
risk assessors on how they understand risk assessment to be conducted
at EPA. It also presents staff recommendations for EPA and interested
parties to consider how EPA can strengthen and, where appropriate,
improve its risk assessment practices. This staff paper does not
represent official EPA policy.
The EPA Science Advisor and other senior EPA officials requested
this report to further the discussion and examination of some broad
questions about risk assessment. EPA assembled a group of risk
assessment professionals from across EPA to examine EPA's principles
and practices, and to prepare this paper. As part of its examination,
the group examined the public comments submitted to OMB in response to
OMB's request for public comment on risk assessment procedures in the
Federal government (68 FR 5492-5527, February 3, 2003). The comments to
OMB were used to help identify practices that the staff paper could
address.
The EPA staff review is supplementary to other activities, such as
revisions to EPA's risk assessment guidelines. Instead of addressing
the specific issues covered by other activities, the staff was charged
with taking a broader look across EPA's risk assessment principles and
practices, and with considering several issues as they relate to EPA
risk assessment in general. Further, the staff developed a set of
recommendations from this review. The recommendations will help EPA
update its agenda for further discussion on risk assessment practices.
EPA is releasing this staff paper as a vehicle for opening up a
broader dialogue among EPA staff, EPA managers, and external parties
about the practice of risk assessment at EPA. Several activities may
take place as a part of this dialogue, including possible workshops
with EPA's Science Advisory Board or other external groups on promising
areas for further development of EPA risk assessment practices. Also,
meetings may be held with states, non-governmental organizations,
tribal groups, professional societies, and other interested parties to
seek their input and suggestions. Releasing this staff paper is an
important step in an ongoing process to help advance risk assessment
principles and practices at EPA. As the dialog proceeds, newer and
better approaches for risk assessment may emerge.
To promote this dialogue, EPA is making this staff paper available
and requests comments on the principles and practices discussed in the
paper. The objective is not to revise the staff paper, but to use it to
focus an active dialogue on risk assessment issues. There will be no
formal response to the comments EPA receives. Rather, the comments will
be used to help EPA focus on particular risk assessment issues to
pursue within EPA and with the interested public. EPA is interested in
suggestions for other avenues for dialogue as well.
II. General Information
A. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification 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; however, late comments may be
considered since the staff paper represents the first step of a multi-
step process.
1. Electronically. If you submit an electronic comment as
prescribed below, 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. EDOCKET. 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 EDOCKET 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 No. ORD-2004-0004.
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 electronic mail (e-mail) to
ORD.Docket@epa.gov, Attention Docket ID No. ORD-2004-0004. 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 II.A.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: U.S. Environmental Protection
Agency, ORD Docket, EPA Docket Center (EPA/DC), Mail Code: 28221T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No.
ORD-2004-0004.
3. By Hand Delivery or Courier. Deliver your comments to: EPA
Docket Center (EPA/DC), Room B-102, EPA West Building, 1301
Constitution Ave., NW., Washington DC, Attention Docket ID No. ORD-
2004-0004; (note: this is not a mailing address). Such deliveries are
only accepted during the Docket's normal hours of operation as
identified in unit II.B.
B. How Should I Submit Confidential Business Information (CBI) to the
Agency, If Necessary?
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
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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 person identified in the FOR FURTHER INFORMATION CONTACT section.
C. How Can I Get or View Copies of Related Information?
EPA has established an official public docket for this action under
Docket ID No. ORD-2004-0004. The official public docket consists of 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 Office of Environmental Information (OEI) Docket in the
Headquarters EPA Docket Center, (EPA/DC) EPA West Building, Room B102,
1301 Constitution Avenue, NW., Washington, DC 20460. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
OEI Docket is (202) 566-1752; facsimile: (202) 566-1753; or e-mail:
ORD.Docket@epa.gov.
An electronic version of the public docket is available through
EDOCKET. You may use EDOCKET 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. Once in the system, select
``search,'' then key in the appropriate docket identification number.
Certain types of information will not be placed in the EDOCKET.
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 EDOCKET, the system will identify whether the document is
available for viewing in EPA's electronic public docket. Publicly
available docket materials that are not available electronically may be
viewed at the docket facility identified above.
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.
Dated: March 19, 2004.
Paul Gilman,
EPA Science Advisor, Office of the Science Advisor.
[FR Doc. 04-6695 Filed 3-24-04; 8:45 am]
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