[Federal Register: September 7, 2004 (Volume 69, Number 172)]
[Notices]
[Page 54144-54148]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se04-52]
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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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[[Page 54145]]
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.
[[Page 54146]]
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
[[Page 54147]]
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.
[[Page 54148]]
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