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.

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 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 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.