Bridging the gap between independent science and regulation

News 2017 / May

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Bridging the gap between independent science and regulation

When I left the academic world and started to work with chemicals policy, I was shocked to learn that what I knew as true, independent peer-reviewed science was disregarded in policy processes as being of lesser quality. I do not think enough scientists are aware of this, and it is not what the funders of scientific studies expect when they invest in research.

What a waste. A waste of knowledge, of resources, of animals and of the opportunity to improve the quality of chemicals regulation.

An example is the proposed EDC criteria for pesticides and biocides, which are still being debated among member states. When defining the scientific data to be taken into account for identification of EDCs this should be:

“a) scientific data generated in accordance with internationally agreed study protocols”
 and

”b) other scientific data selected applying a systematic review methodology”.

While it is encouraging that “other data” is now included, it is odd that this data should go through systematic review, while the standard studies need not.

Marlene Ågerstrand and her colleagues from Stockholm University have just published a scientific paper, “An academic researcher´s guide to increased impact on regulatory assessment of chemicals”, aimed at tackling this issue and raising awareness about this in academia.

I can understand that regulators feel comfortable in relying on studies that have been performed according to established guidelines and in certified laboratories (GLP), but as the paper states: “GLP is not a guarantee for scientific excellence and the standard test guidelines have been criticized for not addressing some of the most sensitive and relevant endpoints.”

It is necessary to have standards in place to ensure that studies sponsored by industry comply with regulatory requirements. But these studies should not be seen as the only reliable source of information about hazards or risks of chemicals.

The scientific community already has a peer-review system in place to assure the quality of published findings. It is the non-standardised academic studies that are driving scientific development and progress.

The consequences of continuing to ignore academic studies are significant, as explained in the paper:

“First we run the risk of making less informed decisions when excluding peer-reviewed studies. Secondly, there is an inherent conflict of interest in the system when the main responsibilities for data gathering and risk assessment lie with the party that has an economic interest in having the chemical on the market”.

The authors describe ten actions points for academic researchers that want to try and improve the use of their research in regulatory processes. These include everything from being aware of regulatory processes and engaging more with stakeholders, to how to better describe the conditions of your research so that policy makers can assess the reliability of your results.

Having these recommendations and raising awareness among scientists is an important task. It is clear that when scientists become more aware of the needs of policy makers, they can make their research more accessible with quite low costs.

However, as is also described in the paper, there is controversy among scientists over whether or not one should discuss the regulatory uses of results. Also, there is no system in place to “reward” scientists for this type of extra work, it does not add to the traditional academic status.

But, in my opinion, there should be no controversy for regulators as to whether or not one should make an extra effort to ensure that all available knowledge has been taken into account before a decision.

While the title indicates that it is a guide for academic researchers I believe this paper would also be very useful reading for all policy makers in the field of chemicals regulation.

 

Anna Lennquist

Dr. Anna Lennquist
Senior Toxicologist, ChemSec