[Federal Register Volume 69, Number 172 (Tuesday, September 7, 2004)]
[Notices]
[Pages 54144-54148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20223]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2004-0079; FRL-7350-2]


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.

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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: [email protected].
    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: [email protected].

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.

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    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 [email protected], 
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

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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.

                  Table 1--Proposed AEGL Chemical Table
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               Chemical name                           CAS No.
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Acetone                                     67-64-1
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Acrolein                                    107-02-8
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Carbon disulfide                            75-15-0
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Chloroform                                  67-66-3
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1,4-Dioxane                                 123-91-1
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Epichlorohydrin                             106-89-8
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Methylmercaptan                             74-93-1
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N,N-Dimethyl formamide                      68-12-2
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Nitric acid                                 7697-37-2
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Nitric oxide                                10102-43-9
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Nitrogen dioxide                            10102-44-0
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Peracetic acid                              79-21-0
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Sulfur dioxide                              7446-09-5
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Trichloroethylene                           79-01-6
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Trimethylchlorosilane                       75-77-4
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List of Subjects

    Environmental protection, Acute Exposure Guideline Levels, AEGL, 
Chemicals, Hazardous substances.



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    Dated: August 27, 2004.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.

[FR Doc. 04-20223 Filed 9-3-04; 8:45 am]
BILLING CODE 6560-50-S