Contribution
My Lords, as the Minister said, this SI does two things. It removes the requirement for 10-yearly renewals of regulated product authorisations and removes the requirement for regulated product authorisations to be prescribed in secondary legislation, instead allowing them to come into effect following a ministerial decision, presumably based on appropriate advice from the FSA.
As is not unusual, and as has been mentioned before, the Secondary Legislation Scrutiny Committee, in its 17th report of this Session, was critical of the Explanatory Memorandum. The efforts of this hard-working committee, which I admire very much, have filled in many of the gaps; however, I feel that it should not have been necessary for it to do this had the department provided a fuller and more helpful explanation of the protections. Is it not for officials to predict the concerns that might arise about new regulations, explain why the Government feel that they have been addressed and put that in the Explanatory Memorandum?
The Government assure us that the changes are intended to simplify the authorisation process and would create
“a more streamlined and effective regulatory regime”.
They cover three regulated product regimes: feed additives; food or feed containing, consisting of or produced from genetically modified organisms; and smoke flavourings. I believe that all these product groups may be subject to new evidence of health or environmental effects—either benefits or dangers—as time goes by. The FSA and the FSS have responded that they
“would continue to assess products at initial application stage to authorise them as safe to be placed on the market, and would maintain their powers to carry out safety reviews of authorised products already on the market at any time if new evidence or risks emerge”.
The words “at any time” are key, because they mean that those organisations do not have to wait 10 years to spot and assess a problem. This is reassuring.
However, as we have heard, Beyond GM was concerned that, in future,
“greater emphasis would be placed on the FSA’s post-market monitoring activities to ensure new evidence and risks are detected before harm occurs”.
I am familiar with the FSA system of horizon scanning in another context. It is thorough, gathering intelligence from international regulators, global networks and its own scientific advisory committee for horizon scanning. It also keeps abreast of analytical methodology and has a well-used incident reporting mechanism. As we speak, revocations of authorisations due to safety concerns reported through this mechanism have generally been actioned outside of the renewal process—in other words, it has not had to wait for 10 years. Can the Minister assure us that the FSA has sufficient resources to keep up this level of horizon scanning and subsequent action? I am clearly not the only Member of this Committee with concerns about this; the same submission from Beyond GM had concerns about it as well, in the light of recent budget cuts and staff shortages.
The FSA responded:
“An evidence-based review system will ensure already authorised products are reviewed based on risk and new evidence, rather than on a fixed timetable”.
This new risk-based system may well be a response to budget cuts, but it could also be justified by the fact that there is no point in wasting precious staff time on reassessing products that have consistently been found to be safe—and I mean “consistently”; one reassessment may not be enough in this field. Can the Minister tell us which of those two options it is? Of course, we might not have needed the Minister’s explanation if the EM had been more helpful.
There were submissions suggesting that GMOs should not have been treated in the same way as other products. The SLSC’s report contains the FSA’s explanation of the additional measures that are in place when GMOs are authorised initially and of how monitoring occurs post market approval. This includes the responsibility of the businesses—the producers, or the people putting the food together—to supply annual reports to the FSA and the FSS about environmental and any other risks that were not predicted at the start of the authorisation. Is the Minister confident that these reports are always sent and are complete? There may be vested interests in not having them complete.
There was a response from the Government Chemist, as we have heard, which was interesting. It considers that the renewals process, which is now being removed, provides important and necessary scientific checks on whether laboratory-based validation methods for GMOs remain current. In other words, it was not about the dangers of GMOs themselves but confidence in the laboratory procedures which assess them. The FSA response says that it will be relying on businesses, which will continue to be required to notify the FSA and the FSS if they have any new information which might affect the suitability of a validation method. Can we rely on businesses to know that and to report any concerns? Given that science is developing so fast in the world of biotechnology, is the Minister confident that we have a regular means of ensuring that we have the best, most up-to-date and accurate methodology, without having to rely on businesses telling us or on this being looked at every 10 years?