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Below are summaries of recent NICEATM-ICCVAM activities through June 2009.
Back to Home page of NICEATM-ICCVAM website
Countries Unite to Reduce Animal Use in Product Toxicity Testing
Representatives from four international agencies, including the director of the U.S. National
Toxicology
Program (NTP), signed a memorandum of cooperation on April 27 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.
“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 NIEHS. “This agreement will
help us achieve greater efficiency by avoiding duplication of effort and allowing us to leverage
limited resources.”
Birnbaum signed as the U.S. representative on behalf of 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 Masahiro Nishijima, Ph.D.
for the Japanese Centre for the Validation of Alternative Methods (JaCVAM).
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 ICCVAM and a scientist at the Consumer Product Safety Commission (CPSC).
“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.
View Memorandum of Cooperation signed April 27, 2009
[PDF]
Federal Agencies Accept ICCVAM Recommendations on
In Vitro Pyrogenicity Test Methods
NICEATM, on behalf of ICCVAM, forwarded ICCVAM recommendations on five in vitro test methods proposed for assessing
potential pyrogenicity of pharmaceuticals and other products to Federal agencies in November 2008.
All agencies accepted or endorsed the ICCVAM recommendations. The agencies’ responses and other
information about the test method evaluation are posted on the
NICEATM-ICCVAM website.
These test methods can now be considered prior to conducting in vivo pyrogenicity testing, and can
be used where determined appropriate for specific testing situations. The availability of these test
methods may reduce
the number of animals required for pyrogenicity testing.
Panel Reviews Alternative Methods for Ocular Safety Assessments
NICEATM and ICCVAM convened an international, independent panel on May 19-21 at Consumer Product
Safety Commission Headquarters in Bethesda, MD to evaluate alternative test methods and approaches
that may further reduce and refine the use of animals for ocular safety testing. The panel included
22 scientists from six countries and was chaired by Dr. Wallace Hayes from the Harvard School of
Public Health.
The Panel reviewed the current validation status of several proposed alternative test methods and
testing approaches according to established Federal and international criteria. The Panel also
commented on draft ICCVAM recommendations regarding the usefulness and limitations of each proposed test method and
approach. They also reviewed the appropriateness of refinements to the in vivo rabbit eye test including
(1) routine use of pain-relieving drugs and (2) humane endpoints that could be used to terminate studies
early. The panel endorsed proposed recommendations by the ICCVAM that are expected to improve
the well-being and reduce the numbers of animals used to determine if consumer products and
other chemicals can cause eye injuries.
The panel’s conclusions and recommendations include:
- Topical anesthetics and systemic analgesics should routinely be used prior to any in vivo
ocular irritancy testing. The panel recommended an enhanced protocol of specific pain-relieving
drugs and schedule of administration to effectively avoid or minimize discomfort.
- Proposed non-animal testing strategies using three in vitro test methods to assess the eye
irritation potential of antimicrobial cleaning products for EPA ocular hazard classification and
labeling purposes appear promising. The panel recommended that studies to further characterize the
in vitro test methods and testing strategies should be designed in coordination with ICCVAM.
- Two in vitro test methods for identifying ocular irritants could be used in limited
circumstances as screening tests to identify some products and substances that would not require
hazard labeling for eye irritation.
The full report is available on the NICEATM-ICCVAM website and public
comments are invited. Public comments can be submitted via e-mail
or
via the comment page on the NICEATM-ICCVAM website. The deadline for comments is August 28, 2009.
ICCVAM will consider the report along with all comments received from the public and from its scientific advisory
committee as it prepares final test method recommendations that will be forwarded to Federal agencies for their
consideration later in 2009. These recommendations, if adopted by Federal agencies, are expected to further
reduce animal use for ocular safety testing, and may potentially eliminate animal pain and distress in situations
where animal testing is still required.
Documents reviewed by the panel and other information can be found on the
NICEATM-ICCVAM website.
ICCVAM has contributed to the approval or endorsement of 27
alternative safety-testing methods by Federal regulatory agencies
since its establishment in 1997. Appropriate use of these test
methods can significantly reduce animal use and improve animal
welfare. ICCVAM has also identified critical research, development, and
validation efforts needed to further advance numerous other alternative methods.
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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