ICCVAM 2010-2011 Biennial Report Now AvailableThe National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of the Biennial Progress Report for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The Biennial Progress Report describes activities and progress by NICEATM and ICCVAM between January 2010 and December 2011. During the past two years, NICEATM, ICCVAM, and ICCVAM member agencies contributed to the national and international endorsement and adoption of 14 new and updated alternative safety testing methods. Since ICCVAM was established, NICEATM, ICCVAM, and the ICCVAM member agencies have contributed to the regulatory acceptance of over 50 alternative methods to protect the health of people, animals, and the environment while reducing, refining, and replacing animaluse. The Biennial Progress Report is available on the NICEATM-ICCVAM website.
Background
The ICCVAM Authorization Act of 2000 established ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences (NIEHS) under NICEATM. The Act directs ICCVAM to prepare biennial reports to be made available to the public on its progress under this Act. This newly available report is the fifth ICCVAM biennial progress report.
Report Highlights
• On behalf of NICEATM and ICCVAM, NIEHS signed an agreement to add the Republic of Korea to the International Cooperation on Alternative Test Methods (ICATM). ICATM was established in 2009 by the United States, the European Union, Japan, and Canada to expedite the worldwide validation and regulatory acceptance of improved alternative test methods. • The Organisation for Economic Co-operation andDevelopment (OECD) adopted an international guidance document prepared by NICEATM and ICCVAM that describes two in vitro test methods to reduce animal use to identify potentially poisonous substances. NICEATM led the international validation studies for the two in vitro test methods, which can reduce animal use by up to 50% for each test. • Federal agencies and the OECD adopted several new versions and applications of the murine local lymph node assay (LLNA), an alternative method recommended by ICCVAM to assess whether substances may cause allergic contact dermatitis. The recommendations reduce animal use for eachtest by 20-40% and support expanded use of the LLNA for nearly all testing situations. Two new “green” versions of the LLNA were adopted that do not require radioactive reagents and will allow laboratories worldwide to take advantage of animal welfare benefits provided by the LLNA. • Federal agencies adopted ICCVAM-recommended alternative test methods and procedures that will further reduce, refine, and replace animal use for eye safety testing. These include the routine use ofmedications to avoid pain and distress when it is necessary to use animals for required safety testing, and the first in vitro test method that can be used in a “bottom-up” approach to identify substances that are not considered eye hazards. • NICEATM, ICCVAM, and their ICATM partners convened the first international workshop on alternative methods for human and veterinary vaccine potency and safety testing. The workshop recommended priority research needed to develop improved and more efficient test methods that can also reduce, refine, and replace animal use. A focused workshop on human and veterinary rabies vaccine test methods was held in 2011, and additionalfocused workshops are planned for 2012 and 2013. • ICCVAM completed an international evaluation of an in vitro test method proposed as a screening test to identify substances with potential endocrine activity. The test method uses engineered human cells to identify substances that induce or inhibit activation of the human estrogen receptor. Use of this test method may reduce the number of animals necessary for endocrine disruptor screening. • NICEATM and ICCVAM convened two workshops on Best Practices for Regulatory Safety Testing to promote the use of improved and more efficient test methods that can also reduce, refine, and replace animal use. Participants learned how to select and use approved alternative methods to assess the safety or potential hazards of chemicals and products. About NICEATM and ICCVAMICCVAM is an interagency committee composed of representatives from 15 U.S. Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of safety testing methods that more accurately assess the safety and health hazards of chemicals and products and that reduce, refine (enhance animal well-being and lessen or avoid pain and distress), or 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 also conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM, ICCVAM, and the ICCVAM member agencies have contributed to the approval or endorsement of over 50 alternative safety testing methods by Federal regulatory agencies and international organizations. Appropriate use of these test methods can better protect human health and significantlyreduce animal use and improve animal welfare. Critical research, development, and validation efforts needed to further advance many other alternative methods have also been identified. NICEATM and ICCVAM welcome nominations and submissions of alternative safety testing methods for validation studies and/or technical evaluations. Nominations and submissions are welcome from any individual ororganization. Please contact NICEATM here for more information or to discuss a possible nomination or submission. Additional information about other NICEATM and ICCVAM activities can be found on the NICEATM–ICCVAM website. Thank you for your interest and your support of NICEATM and ICCVAM.
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