It will come as no surprise to Science First readers that the United States lags behind many other countries in developing an effective plan to implement human-relevant, non-animal approaches for toxicity testing in a safe and timely manner.
To help address this gap, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) met last week to discuss the need for implementing a strategy and roadmap for toxicity testing in the 21st century. SACATM is a federally chartered group charged with providing guidance on “priorities and activities related to the development, validation, scientific review, regulatory acceptance, implementation, and national and international harmonization of new, revised, and alternative toxicological test methods.”
The SACATM meeting addressed a number of important topics, ranging from the needs that are driving alternatives development and acceptance to hurdles that stand in the way of their adoption. Meeting attendees provided insight as to what can be done to overcome these barriers.
Currently, some of the main drivers for the acceptance of alternatives are the need for toxicology data to review the thousands of chemicals in need of testing, the need to reduce testing costs and, of course, ethical concerns. Despite the fact that, compared to animal tests, alternatives offer the promise of being less expensive, more predictive, more reliable, able to produce data faster and able to alleviate the ethical concerns of animal experimentation, alternative methods have not seen widespread acceptance. What hurdles are standing in the way?
The meeting revealed that the leading non-technological barrier to alternatives adoption is regulatory acceptance. One reason for this is confusion over regulatory guidelines which may lead researchers and regulatory bodies to believe animal test data is required when it may not be. Also, if one regulatory agency accepts a non-animal alternative, that doesn’t guarantee its acceptance by other agencies.
Other hurdles include lack of standardization for testing protocols, slowness of the formal validation process and general resistance to change. Scientific barriers exist as well, including the recognition that alternatives may not replace traditional animal tests on a “like-for-like” basis. Combining data from different alternative approaches, however, may provide data that could replace animal tests.
Many individuals stressed the significance of training and educating researchers about available alternatives to increase their familiarity with them, as well as the need for more funding for the development and validation of alternatives. Researchers need funding and will follow the money, and may need an incentive to pursue this avenue of research.
Some meeting participants felt that more could be done legally with respect to language used in regulations describing testing approaches. For instance, regulations that stipulate animal testing could be revised to make the language more neutral or to more clearly spell out how and when alternatives should be used.
Other participants reminded SACATM members that a baseline of the numbers of animals used, as well as more transparency regarding the purpose of their use for testing and research, is necessary for agencies to understand when and how animals are being used. Considering mice, rats, birds and cold-blooded animals are not currently counted in this country, we have no idea how many animals are used, nor whether efforts to implement alternatives are progressing.
The meeting provided a wonderful opportunity for individuals interested in alternatives to come together and discuss both the problems that exist for alternatives adoption as well as potential solutions. However, actions speak louder than words, and we hope to report on the progress that was made in overcoming existing challenges and the adoption of more alternative methods by the time the SACATM annual meeting is held next year.
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