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Below are summaries of recent NICEATM-ICCVAM activities as of January 2009.
Back to Home page of NICEATM-ICCVAM website
Humane Society and Procter and Gamble Recognize NTP for Advancing Alternatives to Animal Testing
On December 18, the Humane Society of the United States (HSUS) and Procter and Gamble presented Raymond Tice, Ph.D., of the
National Toxicology Program (NTP) an award for the outstanding scientific contributions that he and others are making to
advance viable alternatives to animal testing.
The North American Alternative Awards were presented at the HSUS Washington office by Andrew Rowan, Ph.D., the executive vice president
of the HSUS, and Len Sauers, Ph.D., vice president of product safety, regulatory, and technical relations for
Procter and Gamble. The awards recognize the efforts of the recipients to work toward the elimination of animal testing
for consumer product safety while ensuring safe products for consumers and the environment.
Dr. Tice, chief of the NTP Biomolecular Screening Branch and deputy director of the NTP Interagency
Center for the Evaluation of Alternative Toxicological Methods (NICEATM), received the award along with colleagues Christopher Austin, M.D.,
of the National Human Genome Research Institute and Robert Kavlock, Ph.D., of the Environmental
Protection Agency. The award includes a $25,000 grant to support the ongoing alternative methodologies efforts.
The three agencies signed a Memorandum of Understanding
in February 2008 to use the NIH Chemical Genomics Center's (NCGC) high-speed, automated screening robots
to test suspected toxic compounds using cells and isolated molecular targets instead of laboratory animals.
The award will be used to develop toxicity signatures that help determine how toxic a chemical might be and
what type of toxicity it might cause.
"I am pleased that we are receiving recognition by our stakeholders for our
efforts," said Dr. Tice. "The NTP and our sister agencies are working hard to implement the vision
set out by the National Research Council's 2007 Report, Toxicity Testing in the 21st Century: A Vision and a
Strategy."
NICEATM Director Honored
Rear Admiral William Stokes, Director of NICEATM, received the James A. McCallam Award at the 114th meeting of the
Association of Military Surgeons of the United States (AMSUS) in San Antonio, TX, on November 12, 2008. RADM Stokes
received the award in recognition of his outstanding accomplishments in the field of medicine and health. RADM
Steven Galson, Acting Surgeon General of the United States, and Major General (ret) George Anderson, AMSUS
Executive Director presented the award.
RADM Stokes was also honored with the Karl F. Meyer-James H. Steele Gold Head Cane Award by the American
Veterinary Medical Association (AVMA). RADM Stokes received the award in recognition of significant career
achievements that have advanced human health through the practice of veterinary epidemiology and public health.
Dr. Gregory Hammer, the 2007-08 President of the AVMA, presented the award at the 145th AVMA Annual Convention
in New Orleans on July 22, 2008.
ICCVAM Issues Recommendations on In Vitro Pyrogenicity Test Methods
NICEATM announces availability of the (1) ICCVAM Test Method Evaluation Report: Validation Status of Five
In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products
(NIH Publication Number 08-6392) and (2)
Final Background Review Document: Validation Status of Five In Vitro Test Methods Proposed for Assessing
Potential Pyrogenicity of Pharmaceuticals and Other Products (NIH Publication Number 08-6391).
The evaluation report provides recommendations from the Interagency Coordinating Committee on the
Validation of Alternative Methods (ICCVAM) on the usefulness and limitations of five in vitro pyrogen test
methods for detecting Gram-negative bacterial endotoxin in human parenteral pharmaceuticals.
The recommendations are based on
ICCVAM's comprehensive review of the scientific validity of the methods that included an
independent scientific peer review by an international expert panel. The report also provides
recommended test method protocols for the five methods and recommendations for future studies
that might broaden the usefulness of the test methods.
Endotoxin is a component of the Gram-negative bacterial cell membrane that can induce fever
(i.e., is pyrogenic). Parenteral pharmaceuticals, fluids for injection, medical devices, and human
biological products must be properly and accurately evaluated for the presence of endotoxin
contamination prior to their release for clinical use.
ICCVAM
recommends that the test methods should be considered for use on a case-by-case
basis to detect Gram-negative endotoxin in human parenteral drugs, subject to
product-specific validation to demonstrate equivalence to the rabbit pyrogen
test, in accordance with applicable U.S. Food and Drug Administration
regulations. When determined to be valid for specific products and used in this
manner, these methods can reduce the number of animals needed for pyrogenicity
testing. ICCVAM also recommends that these and other in
vitro alternative test methods should be considered prior to in
vivo pyrogenicity testing, and should be used where determined appropriate
for a specific testing situation. However, ICCVAM concludes that none of these
test methods can be considered as a complete replacement for the rabbit pyrogen
test for all testing situations for detecting Gram-negative endotoxin.
The final background
review document provides the data and analyses that support the current
validation status of these five in vitro test
methods. Availability of the test method evaluation report and background review
document was announced on November 24, 2008, in the Federal
Register (73 FR 71003) and are
available on the
NICEATM/ICCVAM web site.
The European Centre for the Validation of Alternative Methods submitted the five
in vitro pyrogen test methods to ICCVAM for formal evaluation of
their scientific validity for regulatory testing purposes.
The ICCVAM recommendations have been
forwarded to U.S. Federal agencies for consideration of regulatory acceptance
according to their specific statutory requirements. The deadline for the
agencies’ responses is April 22, 2009; the responses will be posted on the
NICEATM-ICCVAM website.
2006-2007 ICCVAM Biennial Report
The Biennial
Progress Report for the Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) for 2006-2007 was released on October 23, 2008 (73
FR 63150). The biennial report describes major activities over the past two
years and reiterates ongoing efforts by NICEATM and ICCVAM to promote the
development, validation, and regulatory acceptance of new test methods that will
reduce, refine, and replace the use of animals in testing while maintaining and
promoting scientific quality and the protection of people, animals, and the
environment. Selected highlights include:
- ICCVAM recommended to Federal agencies the first non-animal, ocular
safety-testing methods that can identify substances causing severe eye damage, such as blindness.
- ICCVAM determined that two non-animal,
cell-based assays could reduce animal use for testing that is
required to determine if chemicals and products can cause acute poisoning, the most
common product safety test performed.
- ICCVAM completed evaluation of five non-animal test methods for assessing the fever-
inducing, or pyrogenicity, potential of injectable pharmaceuticals and other products.
- NICEATM initiated an international validation study of a cell-based test method to
determine if it can identify substances that may
disrupt normal hormonal function.
- NICEATM and
ICCVAM strengthened collaborations with European and Japanese counterparts in the areas of validation studies and
review activities.
Since its
establishment in 1997, ICCVAM has contributed to the approval or endorsement of
18 alternative safety-testing methods by Federal regulatory agencies. These test
methods have significantly reduced animal use and improved animal welfare.
ICCVAM has also identified critical research, development, and validation
efforts needed to further advance numerous other alternative methods.
The biennial report is available on the
NICEATM-ICCVAM website
Update on the Murine Local Lymph Node Assay (LLNA)
NICEATM has received and is reviewing
additional data and information on three non-radioactive LLNA test methods and
formulation data from over 70 traditional LLNA studies. These data will be used
in an updated evaluation of the usefulness and limitations of the LLNA test
methods. In addition, previous analyses performed to evaluate the use of the
LLNA for predicting skin sensitization potency in humans have been updated to
include new human reference data. An independent peer review panel is scheduled
to meet in public session on April 28-29, 2009, to consider draft ICCVAM test
method recommendations on the updated LLNA test method analyses.
Questions about NICEATM and ICCVAM activities can be directed to Dr. William S. Stokes, Director, NICEATM: phone 919-541-2384; fax 919-541-0947.
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