Over REACHing chemical tests?
9 Feb 2018 by Evoluted New Media
Unintended consequences of REACH legislation over the use of chemicals could mean a waste of time, resources and lab animals. Russ Swan gets out his pointiest wagging finger and delves into it…
We lost a dog last month, which – as anyone who has ever had a pet will understand – made us a bit sad. It's no tragedy – she was a good old dog (emphasis on the old), and her time was up. Happily it was a short and comfortable departure, with no distress to her, but it has left a spaniel-shaped void in our lives.
No, it's fine, I've just got something in my eye.
All of which makes me think about the unintended consequences of otherwise well-meaning chemical control regulations. REACH, in particular, was implemented late last century in a bid to address legitimate concerns about chemicals in the environment. The result was something of a mini-boom for laboratories here and around the continent, as thousands of chemicals of interest were subjected to thorough toxicology and environmental impact studies.
Who can think this was a bad thing? Certainly not the legislators, who were happy to demonstrate their eco-credentials by taking on the nasty chemical industry and forcing it to test everything it made. Not the labs either, or their suppliers. Work is work, and times are tough.
On the other side, the chemical industry was naturally a bit reluctant to spend large chunks of its cash on new tests which, to some degree, duplicated old ones. They found an unlikely ally in animal protection activists, who suddenly realised that being green was no longer the same as being naïve. Lots of toxicology tests meant lots of animal tests: a bad thing.
“What if I told you that REACH tests that have already been performed might need to be repeated? And what if I told you that the reason was profit? You might, like me, think this was an outrage.”Being duped? Now, I'm not going off on a rant – either pro- or anti- animal testing. It's something we have to do for the greater good of humankind and, until there are alternatives, that is all there is to say. I do look forward to the day when technological improvements mean live beasts are no longer involved. In the meantime, it simply makes sense to reduce testing to what is needed, and avoid duplication. It's expensive in terms of cash, if nothing else.
So what if I told you that a lot of the tests that have already been performed might need to be repeated, several times? This is nothing to do with the quality of the work, but only the geography. And what if I told you that the reason was profit? You might, like me, think this was an outrage.
REACH has been so successful that it is being mimicked in territories outside the EU. Given the global nature of manufacturing industry, you might think this was a generally good thing as it leads to closer harmonisation and brings all the benefits that entails.
To register a chemical in one of these territories, you need test data. This is valuable proprietary information that has been gained at significant cost in expensive European laboratories. Clearly, it won’t be given away for free.
But how much is it worth to a manufacturing company in a developing country? Let's assume that they could repeat the lab work, taking advantage of lower local costs and possibly making use of the latest equipment, for half the original cost in Europe. You might think that half of this, say 25 percent of the original, would be a good starting point. They might want to take production volumes into account, and if the overseas industry was just a third of the size of its European counterpart, this could bring the reasonable cost down to perhaps 10 percent of the original. The data exists. The additional cost to use it should be minimal.
EU must be kidding? Seen from the other perspective, manufacturers are not charities. They own some intellectual property which it is their obligation to exploit to maximum benefit. If they can license their property to several places, and actually turn a cost centre into a profit, what's the harm in that?
You're ahead of me here, aren't you? Any temptation to milk profit from data that has already earned its keep risks the duplication of tests already performed, which would be wasteful of resources, and time, not to mention lab animals. There has to be a better way.
And there's a twist. REACH is an EU process, and countries outside the EU cannot join in. All those tests could, in a nightmare scenario that isn’t actually all that unlikely, have to be repeated in the name of 'taking back control'. This makes me even sadder regarding our own little domestic situation.
Russ Swan