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In My Opinion: The Future of Safety Testing Labs

By: Rich Ulmer
Posted: August 7, 2007, from the August 2007 issue of GCI Magazine.

We’re all familiar with paradigm shifts, but many of us are not as acutely aware of the pace at which these shifts occur or that shifts don’t mean that old paradigms simply vanish. How long did it take for DNA profiling to become standardized for forensic science? Fingerprinting did not merely go away to die. It took 20 years for DNA to become the key tool in this branch. If your lab solely provided fingerprint analysis, however, it is highly likely that business would have begun to drift away long ago. The wise business decision would have been to add DNA testing to your list of services.

In vitro (nonanimal) testing has taken a similar path. It has been commercially available for fewer than 20 years, meaning that you could call your favorite (frequently not local) laboratory and order an in vitro test result. You could have, however, been able to obtain testing from an animal testing laboratory for at least 50 years, and there are numerous such laboratories globally. In fact, these labs far outnumber in vitro testing facilities. Very few are available for commercial work globally (including within the U.S.), and the areas in which nonanimal tests are available are also relatively few.

I submit that we are on the cusp of a new direction in safety testing. Thanks to European regulatory leadership, commercial animal testing laboratories that depend to any appreciable degree on the testing of cosmetic formulations (chemicals/compounds) will either soon (possibly in 2008) see their business decline in that market, partner with an in vitro testing laboratory or become skilled in in vitro testing themselves. This paradigm shift was cemented on May 2, 2007, when the first of what will likely be several in vitro test methods to replace animal testing for skin/eye irritation was approved by the European Centre for the Validation of Alternative Methods (ECVAM), a European government regulatory agency. ECVAM showed an unusual ability to balance risks (public safety) versus benefits (eliminating unnecessary animal testing), and become the first government regulators to actually move
a segment of industry, cosmetics, toward in vitro testing. A date will be set, in the first half of 2009, when no new cosmetic can be introduced in Europe if tested on animals. Other toiletries/personal care product segments will follow, and the U.S., Canada, Korea, India and Japan will likely be the first markets to follow the example set by Europe.

Should current plans come to fruition, this will all happen without compromising consumer safety. I say that because, as has been evident within other areas of the cosmetics industry, self regulation is in—and it must stay in. Both in vitro and animal testing serve the purpose of screening for irritation prior to the human testing that precedes going to full market release. Interestingly, the FDA requested InVitro International’s Irritection Assay System computer software in 1996 for the purpose of reviewing new products and their respectively completed screening. The FDA had no issue with in vitro screening because the liability was still on each company; the company had to test on humans before final government review and going to market release.

It should be noted as part of this discussion that neither animal testing nor human (clinical) testing is perfect in its ability to predict human safety experiences with new products. After spending more than 25 years in pharmaceuticals, both prescription and OTC, I have seen much documentation of variability in both rabbit and human clinical test results—variability from laboratory to laboratory, rabbit to rabbit and group to group—and there is recognition and acknowledgement on the part of regulatory reviewers that in vitro test results cannot be 100% in agreement with either of the aforementioned test methods in any objective data comparison. But balancing benefits and risks is what this is about, and setting aside the economic benefits of time and money saved by nonanimal testing for both laboratories and commercial product manufacturers, society has declared there is real benefit in sparing animals when at least nearly as accurate predictive in vitro test methods are available, and have been for years.