DEFRA consultation on regulation of genetic technologies (closes 17 March)

DEFRA currently has a consultation called “the regulation of genetic technologies”. Post-Brexit adaptations or not? Will we drop the phrase “even if their genetic change(s) could have been produced through traditional breeding” or not?

Post-Brexit, animal welfare protections are being abandoned. We can’t let that continue unbridled. This consultation is not just about animals, however. It is also about agriculture, bacteria and foodstuffs.

If you want to weigh in, you have up to 17 March, 1 minute before midnight. It will take you some time and you’d better have a bunch of references and links to data ready. 
consult.defra.gov.uk/agri-food-chai

It consists of two parts, that is, the actual consultation is Part 1. You can come back to Part 2 later after you’ve completed Part 1. I have been working on Part 1 so far. 

When I downloaded the 14-page document that goes with this gene editing consultation, I spotted several problems. There is a pretence of an emphasis on science and there is at least one or one half paragraph that has nothing to do with genetic technologies (obfuscation).

The document starts as follows:
“Building back greener is integral to creating a healthier, more resilient world for future generations and the Prime Minister has highlighted the need to take a more scientifically credible approach to regulation to help us meet some of the biggest challenges we face.”

This is the document’s fourth paragraph:
While GE is unlikely to be able to address all these complex challenges, a whole range of innovative approaches could help us make progress over time. These could include increasing agro-ecological approaches for land management, the use of robotics and artificial intelligence, vertical farming, and the development of undervalued protein sources.

The part in blue has nothing to do with gene editing. So why throw it in? The first sentence seems to suggest that there may not even be a need for gene editing. What is the purpose of this paragraph? To obfuscate? 

On page 5 it says:
“Our position follows the science, which says that the safety of an organism is dependent on its characteristics and use rather than on how it was produced.” 

That, with all due respect, sounds like pretentious nonsense. No references are given, no scientists are mentioned, no agencies or universities are named.

Anyone wishing to take part in this consultation, however, is supposed to provide evidence and literature references and the consultation is clearly not intended to draw the public’s opinion.

Also on page 5 of the consultation document, DEFRA mentions that Japan, Brazil, Australia and Argentina take a different position than the EU and there is the suggestion that the EU’s view is flawed. 

“Now the transition period has ended, retained EU law requires that all GE organisms are classified as GMOs irrespective of whether they could be produced by traditional breeding methods. This was confirmed by a Court of Justice of the European Union (CJEU) judgment in 20181. This is not consistent with the position taken by most countries who have reviewed their respective regulations like Argentina, Australia, Brazil and Japan, which have concluded that certain GEOs should not be regulated as GMOs.”

There is also a 2-page Gene Editing Explainer, which tells the public what to think, again without providing any literature references or links.

(Only Rothamsted Research in Hertfordshire is mentioned in it. Wikipedia says:
“previously known as the Rothamsted Experimental Station and then the Institute of Arable Crops Research” “one of the oldest agricultural research institutions in the world, having been founded in 1843”. It is located on the campus of “Rothamsted Enterprises”. I assume that it is comparable to some of the departments of Wageningen University and Research. I am unfamiliar with it, had never heard of it before.)

I am a little disgusted with the approach taken by DEFRA here. I have taken part in DEFRA consultations before, when that particular PM mentioned at the start of the document was not PM yet. I may not often agree with DEFRA, but DEFRA’s consultations did not use to annoy me. This one does.

It is a political document, isn’t it?

I may be way off, but I hear the PM’s voice in the background and I sense the assumption that the public at large does not have the capability to understand the science and/or that the public is not well informed enough to be able to contribute to this consultation.

(Note that research in Germany showed that providing more information did not make the public more accepting of the use of genetic technologies; link below. These kinds of studies are not my field of expertise and there may be plenty of studies that found the opposite. But if that were the case, then why did DEFRA provide so little information?) 

Below are my two cents, so far. Also biased, namely skewed toward caution, and written off the cuff.

In my opinion, organisms developed using genetic technologies such as gene editing (GE) must continue to be regulated as genetically modified organisms (GMOs) even if their genetic change(s) could have been produced through traditional breeding.

  1. Genetic technologies can have side effects that are not necessarily instantly clear. An example could be that the changes that Dr He introduced in a pair of human twins in China to make them immune to HIV could also have resulted in “off-target” changes and scientists are largely still in the dark about this. (Natural breeding does not have the potential for unintended changes that CRISPR still has.)
  2. The application of genetic technologies may also impact animal welfare differently than when their genetic change(s) are produced through traditional breeding. 

Regarding the question as to the risk associated with the application, the problem is that we cannot predict what we don’t know yet.

If you look back into history, you can see that in the past, we’ve often hailed as great progress what we later ended up banning.

  • We gave a Nobel Prize in medicine for the development of DDT. It almost eradicated the American bald eagle and that is only one aspect of its many side effects. DDT causes nerve damage and affects the hormone-producing systems of many animals, among other things lowering their fertility. In the United States, it was the environmentalist and marine biologist Rachel Carson’s work that eventually led to a ban on DDT and other pesticides.
  • We didn’t even foresee the blatantly obvious consequences of insecticides, namely that their use would affect pollination as well as bird populations.
  • Should I mention thalidomide? DES? That ibuprofen may affect male fertility?
  • Many people are pushing to have other harmful pesticides banned, such as glyphosate and chlorpyrifos. That isn’t because they’re afraid of progress. It’s because these substances are not as harmless as we thought.
  • When I was still based in the Netherlands and a board member of the Environmental Chemistry (and Toxicology) Section of the Royal Netherlands Chemical Society, our section organised a symposium on brominated flame retardants. They were already being found in tissues of animals in the Arctic. Did we see any of that coming? No, we did not. Subsequently, there was a push to phase them out in favour of others that turned out to have similar problems.
  • Did we expect to do damage to the ozone layer when we introduced CFCs?
  • Should I mention PFAS? (You may want to look into the situation in the Netherlands, where PFAS in soil have caused major upheaval because the Dutch want very little of it in their soils and the stuff is everywhere. When permitted levels were lowered, construction ground to a halt all over the country.) But we all thought that non-stick coatings (also called Teflon, PTFE, polytetrafluorethylene etc) were the greatest thing since sliced bread. People with pet birds started noticing disastrous effects. Perfluorooctanoic acid (PFAO), also known as C8, dissolves well in water and does not decay. It is now globally present in the air and in seawater. In the Netherlands, discharges by the Chemours plant in Dordrecht led to increased PFOA concentrations in the Merwede river and in the groundwater along its banks. In the U.S., a former DuPont plant in West Virginia released more than 1.7 million pounds of C8 into the region’s water, soil and air between 1951 and 2003. C8 was phased out after a class-action lawsuit that alleged that it causes cancer. Chemours now makes a new compound called GenX instead, for which safety thresholds have yet to be established. Regular water treatment methods don’t remove it from drinking water. GenX may be safer than C8, but it is also alleged to have caused tumours and reproductive problems in lab animals.

None of what I just wrote has anything to do with the use of genetic technologies. My point is that we never know with 100% certainty that all forms of progress are safe and we have missed the blatantly obvious in the past. This uncertainty also goes for genetic technologies. 

I also think that dropping “even if their genetic change(s) could have been produced through traditional breeding” would likely make the regulation harder to apply. It would have companies trying to find all sorts of shortcuts (to “prove” that the effect of the technology they used could also have been produced through natural breeding). It might lead to frustrating discussions and costly legal proceedings. It might even lead to more campaigning, protests, etc.

(I did not look into how Japan, Brazil, Argentina and the United States handle these matters.)

There might well be effects on trade as well. German consumers for example traditionally have put great emphasis on ensuring that their food is as “clean” as possible.

https://www.loc.gov/law/help/restrictions-on-gmos/germany.php

https://www.researchgate.net/publication/326462738_Does_information_change_German_consumers’_attitudes_about_genetically_modified_food
From the abstract:

“The consumers who are more accepting of genetic modifications are younger, less educated and less concerned about their nutrition. The average effect of our provided information is negligible. However, the initially less opposed become slightly more opposed. Our results thus do not support the view that a lack of information drives consumer attitudes. Instead, attitudes seem to mostly reflect fundamental preferences.”

Many of the questions and the choices for answers in the DEFRA consultation survey are blatantly biased and it is quite clear that DEFRA would like to see the phrase “even if their genetic change(s) could have been produced through traditional breeding” dropped.

Am I being too critical? I don’t think so.

See also for example these two articles:

https://angelinasouren.com/2018/12/11/an-opinion/ by Cecile Janssens, professor at Emory University. A quote: “Most DNA mutations do nothing else other than cause the disease, but DNA variations may play a role in many diseases and traits. Take variations in the MC1R “red hair” gene, which not only increases the chance that your child will have red hair, but also increases their risk of skin cancer. Or variations in the OCA2 and HERC2 “eye color” genes that are also associated with the risk of various cancers, Parkinson’s and Alzheimer’s disease. To be sure, these are statistical associations, reported in the scientific literature, some may be confirmed; others may not. But the message is clear: Editing DNA variations for “desirable” traits may have adverse consequences, including many that scientists don’t know about yet.


https://www.nature.com/articles/d41586-019-02087-5

 

So, what exactly is the science that DEFRA claims to be following? It is not this kind of science.



It is too soon to abandon caution. 
 

12 March 2021
Here is the PDF with my response: 

DEFRA-my_response

I expected Part 2 to take as long as Part 1 – I imagine that the start of Part 2 is the point at which many give up – but it did not. And in essence, it was a repeat of Part 1.

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