[Federal Register Volume 73, Number 2 (Thursday, January 3, 2008)]
[Notices]
[Pages 493-495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25536]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Toxicology Program (NTP); NTP Interagency Center for the
Evaluation of Alternative Toxicological Methods (NICEATM); Workshop on
Acute Chemical Safety Testing: Advancing In Vitro Approaches and Humane
Endpoints for Systemic Toxicity Evaluations
AGENCY: National Institute of Environmental Health Sciences (NIEHS),
National Institutes of Health (NIH).
ACTION: Workshop announcement.
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SUMMARY: The Interagency Committee on the Validation of Alternative
Methods (ICCVAM) and NICEATM announce the upcoming ``Scientific
Workshop on Acute Chemical Safety Testing: Advancing In Vitro
Approaches and Humane Endpoints for Systemic Toxicity Evaluations.''
The goals of the workshop are to:
(1) Review the state-of-the-science and identify knowledge gaps
regarding the key pathways involved in acute systemic toxicity.
(2) Recommend how these knowledge gaps can be addressed by
collecting mechanistic biomarker data during currently required in vivo
safety testing.
(3) Recommend how key in vivo pathway information can be used to
develop more predictive mechanism-based in vitro test systems and
earlier, more humane endpoints for in vivo test methods.
(4) Recommend how mechanism-based in vitro test systems and
earlier, more humane endpoints can be used to further reduce, refine,
and eventually replace animal use for acute systemic toxicity testing
while ensuring the protection of human and animal health.
This workshop is open to the public with attendance limited only by
the space available.
DATES: The workshop will be held on February 6-7, 2008.
ADDRESSES: The workshop will be held at the NIH, Natcher Conference
Center, 45 Center Drive, Bethesda, MD 20892. A draft agenda and other
information are available on the ICCVAM workshop Web site (http://iccvam.niehs.nih.gov/meetings/AcuteToxWksp08/AcuteToxWksp08.htm) and
can be obtained from NICEATM (see FOR FURTHER INFORMATION CONTACT
below).
FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, NICEATM
Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC
27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail)
[email protected].
SUPPLEMENTARY INFORMATION:
Background
NICEATM and ICCVAM convened a peer review panel meeting in 2006.
The panel was charged to determine the
[[Page 494]]
usefulness and limitations of two in vitro cytotoxicity test methods
for determining starting doses for two acute oral toxicity test
methods, the Up-and-Down Procedure and the Acute Toxic Class method, in
order to reduce the number of animals used in each of these in vivo
tests. The panel's conclusions and recommendations are described in the
Peer Review Panel Report: The Use of In Vitro Basal Cytotoxicity Test
Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity
Testing (available at http://iccvam.niehs.nih.gov/methods/acutetox/inv_nru_scpeerrev.htm). The panel recommended that ICCVAM consider
convening a working group to explore mechanisms of action for acute
toxicity and to identify approaches for acquiring additional
information on acute toxicity mechanisms when conducting required in
vivo acute toxicity testing. The Scientific Advisory Committee on
Alternative Toxicological Methods (SACATM) met by teleconference on
August 3, 2006, and expressed support for the panel's recommendations
(minutes of that meeting are available at http://ntp.niehs.nih.gov/files/SACATMAug06MinutesVF081506.pdf).
NICEATM and ICCVAM included activities in their draft Five-Year
Plan (2008-2012) (http://iccvam.niehs.nih.gov/docs/5yearplan.htm) to
further reduce animal use and potential pain and distress associated
with acute toxicity testing. These included organizing an international
workshop to (1) identify predictive and more humane endpoints that may
be used to terminate studies earlier in order to further reduce the
severity and duration of pain and distress and (2) identify and
standardize procedures for collecting mechanistic information from in
vivo acute oral toxicity testing that will aid in developing batteries
of predictive in vitro test methods that can further reduce and
eventually replace animals for acute toxicity testing.
The ICCVAM Acute Toxicity Working Group subsequently organized this
workshop in coordination with NICEATM, the European Centre for the
Validation of Alternative Methods, and the Japanese Center for the
Validation of Alternative Methods. The goals of the workshop are to:
(1) Review the state-of-the-science and identify knowledge gaps
regarding the key pathways involved in acute systemic toxicity.
(2) Recommend how these knowledge gaps can be addressed by
collecting mechanistic biomarker data during currently required in vivo
safety testing.
(3) Recommend how key in vivo pathway information can be used to
develop more predictive mechanism-based in vitro test systems and
earlier more humane endpoints for in vivo test methods.
(4) Recommend how mechanism-based in vitro test systems and
earlier, more humane endpoints can be used to further reduce, refine,
and replace animal use for acute systemic toxicity testing while
ensuring the protection of human health.
Workshop Attendance and Registration
The workshop will be held on February 6-7, 2008, at the NIH Natcher
Conference Center, 45 Center Drive, Bethesda, MD 20892. Sessions will
begin at 8 a.m. and end at approximately 5 p.m. on both days. Persons
needing special assistance in order to attend, such as sign language
interpretation or other reasonable accommodation, should contact 919-
541-2475 voice, 919-541-4644 TTY (text telephone, through the Federal
TTY Relay System at 800-877-8339), or e-mail [email protected].
Requests should be made at least seven days in advance of the event.
This workshop is open to the public with attendance being limited only
by the space available. Individuals who plan to attend are encouraged
to register in advance with NICEATM. Registration information, an
agenda, and additional information are available on the workshop Web
site (http://iccvam.niehs.nih.gov/meetings/AcuteToxWksp08/AcuteToxWksp08.htm) and upon request to NICEATM (see FOR FURTHER
INFORMATION CONTACT above).
Preliminary Workshop Agenda
Day 1--Wednesday, February 6, 2008
Opening Plenary Session--Welcome and Overview of Workshop
Objectives.
Session 1--Current Acute Systemic Toxicity Injury and
Toxicity Assessments.
Session 2--Key Pathways and Biomarkers for Acute Systemic
Toxicity.
Concurrent Breakout Group (BG) Discussions:
--BG 1: Acute Systemic Toxicity Injury and Toxicity Assessments.
--BG 2: Key Pathways and Biomarkers for Acute Systemic Toxicity.
Adjournment.
Day 2--Thursday, February 7, 2008
Plenary Session--Discussion of Conclusions and
Recommendations from Breakout Groups 1 and 2.
Session 3--Developing Earlier Humane Endpoints for Acute
Systemic Toxicity.
Session 4--State of the Science: Using In Vitro Methods to
Predict Acute Systemic Toxicity.
Concurrent BG Discussions:
--BG 3: Developing Earlier Humane Endpoints for Acute Systemic Toxicity
Testing.
--BG 4: Applying In Vivo Mechanistic Pathway Information to the
Development and Validation of In Vitro Methods for Assessing Acute
Systemic Toxicity.
--BG 5: Partnering with Industry to Advance Acute Toxicity Alternative
Test Method Development, Validation, and Use.
Plenary Session--Discussion of Conclusions and
Recommendations from Breakout Groups 3, 4, and 5.
Workshop Adjournment.
Background Information on ICCVAM, NICEATM, and SACATM
ICCVAM is an interagency committee composed of representatives from
15 Federal regulatory and research agencies that use, generate, or
disseminate toxicological information. ICCVAM conducts technical
evaluations of new, revised, and alternative methods with regulatory
applicability and promotes the scientific validation and regulatory
acceptance of toxicological test methods that more accurately assess
the safety and hazards of chemicals and products and that refine,
reduce, and replace animal use. The ICCVAM Authorization Act of 2000
(42 U.S.C. 285l-3) established ICCVAM as a permanent interagency
committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and
provides scientific and operational support for ICCVAM-related
activities. NICEATM and ICCVAM work collaboratively to evaluate new and
improved test methods applicable to the needs of Federal agencies.
Additional information about ICCVAM and NICEATM can be found on their
Web site (http://iccvam.niehs.nih.gov).
SACATM was established January 9, 2002, and is composed of
scientists from the public and private sectors (Federal Register, Vol.
67, No. 49, page 11358, March 13, 2002). SACATM provides advice to the
Director of the NIEHS, ICCVAM, and NICEATM regarding the statutorily
mandated duties of ICCVAM and activities of NICEATM. Additional
information about SACATM, including the charter, roster, and records of
past meetings, can be found at http://ntp.niehs.nih.gov/go/167.
[[Page 495]]
Dated: December 19, 2007.
Samuel H. Wilson,
Acting Director, National Institute of Environmental Health Sciences
and National Toxicology Program.
[FR Doc. E7-25536 Filed 1-2-08; 8:45 am]
BILLING CODE 4140-01-P