National Advisory Committee for Acute Exposure Guideline Levels (AEGLs) for Hazardous Substances, Proposed AEGL Values; Notice of Availability

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances (NAC/AEGL Committee) is developing AEGLs on an ongoing basis to provide Federal, State, and local agencies with information on short-term exposures to hazardous chemicals. This notice provides a list of 15 Proposed AEGL chemicals that are available for public review and comment. Comments are welcome on both the AEGL values and the Technical Support Documents placed in the public version of the official docket.

DATES:

Comments, identified by docket ID number OPPT-2004-0079, must be received on or before October 7, 2004.

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: Paul S. Tobin, Designated Federal Officer (DFO), Office of Pollution Prevention and Toxics (7406M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8557; e-mail address: tobin.paul@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the general public to provide an opportunity for review and comment on “Proposed” AEGL values and their supporting scientific rationale. This action may be of particular interest to anyone who may be affected if the AEGL values are adopted by government agencies for emergency planning, prevention, or response programs, such as EPA's Risk Management Program under the Clean Air Act and Amendments Section 112r. It is possible that other Federal Agencies besides EPA, as well as State and local agencies and private organizations, may adopt the AEGL values for their programs. As such, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the DFO 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 identification (ID) number OPPT-2004-0079. The official public docket consists of the Technical Support 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 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 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-2004-0079. 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-2004-0079. 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-2004-0079. 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 person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we propose, new approaches we have not considered, the potential impacts of the various options (including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. 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 notice or 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.

II. What Action is the Agency Taking?

EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) provided notice on October 31, 1995 (60 FR 55376) (FRL-4987-3) of the establishment of the NAC/AEGL Committee with the stated charter objective as “the efficient and effective development of AEGLs and the preparation of supplementary qualitative information on the hazardous substances for Federal, State, and Local agencies and organizations in the private sector concerned with chemical emergency planning, prevention, and response.” The NAC/AEGL Committee is a discretionary Federal advisory committee formed with the intent to develop AEGLs for chemicals through the combined efforts of stakeholder members from both the public and private sectors in a cost-effective approach that avoids duplication of efforts and provides uniform values, while employing the most scientifically sound methods available.

In this document the NAC/AEGL Committee is publishing proposed AEGL values and the accompanying scientific rationale for their development for 15 hazardous substances. These values represent the eighth set of exposure levels proposed and published by the NAC/AEGL Committee. EPA published “Proposed” AEGLs for 12 chemicals in the Federal Register of October 30, 1997 (62 FR 58840-58851) (FRL-5737-3); for 10 chemicals in the Federal Register of March 15, 2000 (65 FR 14186-14196) (FRL-6492-4); for 14 chemicals in the Federal Register of June 23, 2000 (65 FR 39263-39277) (FRL-6591-2); for 7 chemicals in the Federal Register of December 13, 2000 (65 FR 77866-77874) (FRL-6752-5) for 18 chemicals in the Federal Register of May 2, 2001 (66 FR 21940-21964) (FRL-6776-3); for 8 chemicals in the Federal Register of February 15, 2002 (67 FR 7164-7176) (FRL-6815-8); and for 10 chemicals in the Federal Register of July 18, 2003 (68 FR 42710-42726) (FRL-7189-8) in order to provide an opportunity for public review and comment. Background information on the AEGL Program may be found in these earlier Federal Register notices, in the EDocket, or on the AEGL web page ( http://www.epa.gov/oppt/aegl ).

Following public review and comment, the NAC/AEGL Committee will reconvene to consider relevant comments, data and information that may have an impact on the Committee's position and will again seek consensus for the establishment of Interim AEGL values. Although the Interim AEGL values will be available to Federal, State and Local agencies and to organizations in the private sector as biological reference values, it is intended to have them reviewed by a subcommittee of the National Academies of Science (NAS). An NAS subcommittee review will serve as a peer review of the Interim AEGLs and the subcommittee will be the final arbiter in the resolution of issues regarding the AEGL values, and the data and basic methodology used for setting AEGLs. Following concurrence, “Final” AEGL values will be published under the auspices of the NAS.

The NAC/AEGL Program is working to ensure that emergency responders and risk managers in this country and abroad are armed with vital information they need to protect the public and themselves from harm in the event of chemical accidents or homeland security emergencies. Because of the serious nature of chemical emergency situations, it is essential that involved personnel have access to the most comprehensive and realistic assessments of human health hazards posed by released chemicals. Underestimation of human health hazard would not be protective, while over estimation might suggest a larger than necessary response zone. The Department of Army and Federal Emergency Management Agency Chemical Stockpile Emergency Preparedness Program (CSEPP), for example, has adopted, as outlined in CSEPP Policy Paper Number 20, AEGLs for sulfur mustard and nerve agents for use in CSEPP community emergency planning and response activities “to prevent or minimize exposures above AEGL-2, above which some temporary but potentially escape-impairing effects could occur.” Thus, with the application of the procedures discussed in this unit, the AEGL Program recognizes the importance of considering all available domestic and international test data, both animal and human, to determine threshold levels of harm for a range of exposure scenarios critical to those at the front line in defending public health. The process for development of AEGL values incorporates essential scientific and ethical considerations posed by the possible use of research with human subjects. All human studies that were used as key or supporting evidence to derive AEGL values were judged acceptable for use according to ethical considerations detailed in the Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Substances, Subcommittee on Acute Exposure Guideline Levels, National Research Council, National Academy Press, 2001, p. 53. The SOP states “The NAC/AEGL Committee is dependent upon existing clinical, epidemiologic, and case report studies published in the literature for data on humans. Many of these studies do not necessarily follow current guidelines on ethical standards that require effective, documented, informed consent from participating human subjects. Further, recent studies that followed such guidelines may not include that fact in the publication. Although human data may be important in deriving AEGL values that protect the general public, utmost care must be exercised to ensure first of all that such data have been developed in accordance with ethical standards. No data on humans known to be obtained through force, coercion, misrepresentation, or any other such means will be used in the development of AEGLs. The NAC/AEGL Committee will use its best judgment to determine whether the human studies were ethically conducted and whether the human subjects were likely to have provided their informed consent. Additionally, human data from epidemiologic studies and chemical accidents may be used. However, in all instances described here, only human data, documents, and records will be used from sources that are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or indirectly. These restrictions on the use of human data are consistent with the ‘Common Rule’ published in the Code of Federal Regulations (Protection of Human Subjects, 40 CFR 26, 2000).” Additionally, EPA has recently asked the NAC/AEGL Committee to add an explicit documentation step early in the AEGL development process that the studies proposed for consideration have been consistent with the Program's Standing Operating Procedures (SOPs).

Human data along with animal data, where available, were used to develop AEGL values for 11 out of 15 chemicals listed in this FR notice. Human data were not used as key or supporting studies for 4 chemicals: Chloroform; methyl mercaptan; dimethylformamide; and nitric oxide. Each human study used in the development of AEGL values underwent an ethics review. There was no evidence to suggest that the studies were fundamentally unethical, or significantly deficient relative to ethical standards prevailing when and where they were conducted.

III. List of Chemicals

On behalf of the NAC/AEGL Committee, EPA is providing an opportunity for public comment on the AEGLs for the 15 chemicals identified in the following table. Technical Support Documents and key literature references may be obtained as described in Unit I.B.1.

List of Subjects

• Environmental protection
• Acute Exposure Guideline Levels
• AEGL
• Chemicals
• Hazardous substances