Representatives from four international agencies, including the
director of the U.S. National Toxicology Program (NTP), today signed
a memorandum of cooperation that could reduce the number of animals
required for consumer product safety testing worldwide. The agreement
between the United States, Canada, Japan and the European Union
will yield globally coordinated scientific recommendations on alternative
toxicity testing methods that should speed their adoption in each
of these countries, thus reducing the number of animals needed
for product safety testing. The memorandum is available at http://iccvam.niehs.nih.gov/docs/about_docs/ICATM-MOC.pdf.
"Signing this international agreement demonstrates our commitment
to finding and advancing alternatives to animal testing," said
Linda Birnbaum, Ph.D., director of the NTP and National Institute
of Environmental Health Sciences, part of the National Institutes
of Health. "This agreement will help us achieve greater efficiency
by avoiding duplication of effort and allowing us to leverage limited
Birnbaum signed as the U.S. representative on behalf of the NTP
Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM), one of the national validation organizations
participating in the agreement. Others who signed include Elke
Anklam, Ph.D., for the European Centre for the Validation of Alternative
Methods (ECVAM), David Blakey, D.Phil., for the Environmental Health
Science and Research Bureau within Health Canada, and Mashiro Nishijama,
Ph.D. for the Japanese Centre for the Validation of Alternative
The agreement promotes enhanced international cooperation and
coordination on the scientific validation of non- and reduced-animal
toxicity testing methods. If the toxicity testing methods are shown
to be reproducible based on strong scientific information, and
able to accurately identify product related health hazards, the
tests are more readily accepted by regulatory agencies.
"The memorandum covers three critical areas of test method
evaluation: validation studies, independent scientific peer review
meetings and reports, and development of test method recommendations
for regulatory consideration," said Marilyn Wind, Ph.D., chair
of the Interagency Coordinating Committee on the Validation of
Alternative Methods and a scientist at the Consumer Product Safety
"This international cooperation will benefit both people
and animals," said William Stokes, D.V.M., director of NICEATM
and executive director of ICCVAM. Stokes is also an assistant surgeon
general in the U.S. Public Health Service. "The cooperation
will serve an important role in translating research advances into
more effective public health prevention tools. It will speed the
adoption of new test methods based on advances in science and technology
that will provide more accurate predictions of safety or hazard.
Animal welfare will also be improved by the national and international
acceptance of alternative test methods that reduce, refine, and
replace the use of animals."
Federal agencies are committed to the welfare of animals used
in research. All animals used in federally-funded research are
protected by laws, regulations and policies to ensure they are
used in the smallest number possible and with the greatest commitment
to their comfort. ICCVAM is working to promote the development
and validation of alternative test methods. Alternative test methods
are those that accomplish one or more of the 3Rs — reducing
the number of animals used in testing, or refining procedures so
animals experience less pain and distress, or replacing animals
with non-animal systems.
"We are very pleased to be part of this effort and to continue
our already successful collaboration in a formalized manner," said
Elke Anklam, Ph.D., director for the Institute of Health and Consumer
Protection of the European Commission's Joint Research Centre,
where the European Centre for the Validation of Alternative Methods,
ICCVAM’s European counterpart, is located. Anklam has signed the
agreement as representative on behalf of the EU. Her colleague
Joachim Kreysa, Ph.D., the recently appointed head of ECVAM, further
remarked, "I am enthusiastic about the agreement. Our collaboration
will help to identify and embrace scientifically sound and robust
new testing approaches, ensuring that safety assessments are never
compromised, while at the same time reduce the need for animal
"Although we’ve had informal collaborations over the years,
this more formal agreement will allow us to work more efficiently
and effectively," said Hajime Kojima, Ph.D., director of the
Japanese Centre for the Validation of Alternative Methods.
David Blakey, D.Phil., director of the Environmental Health Science
and Research Bureau within Health Canada, added that the effort
is a major step forward. "Increased coordination, collaboration
and communication will clearly enhance the global progress in this
The European Centre for the Validation of Alternative Methods
coordinates validation studies on proposed alternative methods,
evaluates the results by peer review, and provides recommendations
to the European Union National Coordinators for regulatory acceptance
of the methods validated. For more information on ECVAM, visit http://ecvam.jrc.it/.
The Japanese Centre for the Validation of Alternative Methods
is a component of Japan’s National Institute of Health Sciences
and was established in 2005 to coordinate validation studies on
proposed alternative methods, conduct peer reviews of test methods,
and provide recommendations to regulatory authorities.
The Environmental Health Science and Research Bureau within Health
Canada coordinates activities relevant to health-related test method
validation and acceptance issues. For additional information, visit http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hecs-dgsesc/sep-psm/ehsrb-bsser-eng.php.
The National Toxicology Program (NTP) is an interagency program
established in 1978. The program was created as a cooperative effort
to coordinate toxicology testing programs within the federal government,
strengthen the science base in toxicology, develop and validate
improved testing methods, and provide information about potentially
toxic chemicals to health, regulatory, and research agencies, scientific
and medical communities, and the public. The NTP is headquartered
at the National Institute of Environmental Health Sciences (NIEHS).
For additional information, visit http://ntp.niehs.nih.gov.
The NTP Interagency Center for the Evaluation of Alternative Toxicological
Methods (NICEATM) administers and provides scientific support for
ICCVAM and is a part of the NTP at the NIEHS. For additional information,
visit NICEATM at http://iccvam.niehs.nih.gov/about/about_NICEATM.htm.
NIEHS supports research to understand the effects of the environment
on human health and is part of the National Institutes of Health
(NIH). For more information on environmental health topics, visit
our website at http://www.niehs.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and Centers
and is a component of the U.S. Department of Health and Human Services.
It is the primary federal agency for conducting and supporting basic,
clinical and translational medical research, and it investigates
the causes, treatments, and cures for both common and rare diseases.
For more information about NIH and its programs, visit www.nih.gov.