[Federal Register Volume 69, Number 58 (Thursday, March 25, 2004)]
[Notices]
[Pages 15326-15328]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6695]


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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 [email protected].

SUPPLEMENTARY INFORMATION:

I. Background Information

    The staff paper, ``An Examination of EPA Risk Assessment Principles 
and

[[Page 15327]]

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 
[email protected], 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: 
[email protected].
    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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