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EU The Courts Science

European Court Ruling Raises Hurdles For CRISPR Crops (sciencemag.org) 100

Okian Warrior shares a report from Science Magazine: Hopes for an easier regulatory road for genetic engineering in European agriculture were dashed by the Court of Justice of the European Union. In a closely watched decision, the court ruled that plants created with new gene-editing techniques that don't involve transferring genes between organisms -- such as CRISPR -- must go through the same lengthy approval process as traditional transgenic plants. Many researchers had argued that regulators should take a lighter touch when evaluating products created with the new technologies, but environmental groups and their allies successfully argued that they should be subject to the same EU rules that apply to other genetically modified organisms.

The case focused on crops that have been made resistant to herbicides without transferring genes from other species. The French government had passed a law exempting these new gene-edited crops from regulation under the European Union's directive on genetically modified organisms (GMOs), which requires an assessment of risks to health and the environment, as well as labeling, tracking, and monitoring of the products. Confederation Paysanne, a French union in Bagnolet representing small farms, and eight other groups, sued and charged that the plants modified with gene-editing techniques should be regulated under the GMO directive, because they could cause significant harm. The court decided that gene-editing techniques are covered by the GMO directive because they "alter the genetic material of an organism in a way that does not occur naturally." (The court exempted conventional mutagenesis -- the unnatural use of chemicals or radiation to create mutations for plant breeding -- because it has "a long safety record.") It also said the new gene-editing techniques have risks that could be similar to those of transgenic engineering.

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European Court Ruling Raises Hurdles For CRISPR Crops

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  • by Nidi62 ( 1525137 ) on Monday July 30, 2018 @09:29AM (#57032292)

    The court exempted conventional mutagenesis -- the unnatural use of chemicals or radiation to create mutations for plant breeding -- because it has "a long safety record."

    Maybe it's just because I've played so much Fallout, but I'll take genetically edited food over irradiated food any day....cutting out genes (and as the summary says, not adding genes-especially genes from other organisms)has to be inherently safer than dosing what's destined to be our food with radiation.

    • Re:*Head asplodes* (Score:5, Interesting)

      by Oswald McWeany ( 2428506 ) on Monday July 30, 2018 @09:41AM (#57032340)

      The court exempted conventional mutagenesis -- the unnatural use of chemicals or radiation to create mutations for plant breeding -- because it has "a long safety record."

      Maybe it's just because I've played so much Fallout, but I'll take genetically edited food over irradiated food any day....cutting out genes (and as the summary says, not adding genes-especially genes from other organisms)has to be inherently safer than dosing what's destined to be our food with radiation.

      If the radiation is to create mutations in the seed, then that is not the same as irradiating your food. They're merely trying to increase the rate of mutations in hope that some are positive mutations.

      • Somebody's playing X-Men or Fantastic 4 with seeds.

      • Re:*Head asplodes* (Score:5, Informative)

        by fph il quozientatore ( 971015 ) on Monday July 30, 2018 @09:54AM (#57032402)
        True. Nevertheless, I still find it safer to eat food with one precisely crafted modification, rather than food that has gone through random mutations, including possibly dangerous unintended ones.
        • Re:*Head asplodes* (Score:5, Insightful)

          by ShanghaiBill ( 739463 ) on Monday July 30, 2018 @10:15AM (#57032512)

          rather than food that has gone through random mutations

          Every single thing you eat has random mutations, whether from background radiation, cosmic rays, viruses, errors during mitosis/meiosis, etc.

          What the Europeans are doing is technophobic nonsense, with no basis in science. The courts should not be used to enforce superstitions.

          • Re:*Head asplodes* (Score:4, Insightful)

            by Oswald McWeany ( 2428506 ) on Monday July 30, 2018 @10:32AM (#57032582)

            rather than food that has gone through random mutations

            Every single thing you eat has random mutations, whether from background radiation, cosmic rays, viruses, errors during mitosis/meiosis, etc.

            What the Europeans are doing is technophobic nonsense, with no basis in science. The courts should not be used to enforce superstitions.

            I think there is definitely an irrational fear of GMO food in Europe; however, some caution is needed- when you're doing some of the things you're doing with CRISPR you're bypassing what would take, in some cases, millions of generations of selective breeding, to get a gene in place that doesn't naturally exist anywhere in that species.

            There needs to be some common sense and oversight, to make sure, for example, pesticide resistance in a crop doesn't get crossed with a wild relative of the crop and spread to a wild population of an undesirable plant.

            Yeah, that could happen with selective breeding too... but there would be many-many between generations where you'd probably catch that first.

            • Re: (Score:3, Interesting)

              to make sure, for example, pesticide resistance in a crop doesn't get crossed with a wild relative of the crop and spread to a wild population of an undesirable plant.

              The OBVIOUS way to ensure this doesn't happen is to edit out the pollen production so that the GMO plant IS NOT CAPABLE OF REPRODUCTION. The gene can't pass to the wild stock if there is nothing being passed.

              This is known as a "terminator gene", and the anti-GMO activists vehemently objected to it, and were successful in getting terminator genes banned in both Europe and America.

              Why? Answer: Because it removes one of their best objections to GMO. They want to make GMO intentionally MORE RISKY just so th

              • by Anonymous Coward

                On the other hand, including a terminator gene sounds like a pretty excellent way to create DRM for plants.

                • On the other hand, including a terminator gene sounds like a pretty excellent way to create DRM for plants.

                  We already have that. Most seeds planted by 1st-world farmers are either GMO or hybrids, and new seed is purchased each year. For most crops, farmers do not save seeds from one year to the next.

                  3rd-world farmers routinely save seeds for planting, but this leads to far lower productivity. They would be much better off buying hybrid or GMO seeds annually. The higher yields and decreased inputs (insecticide, herbicide, and fertilizer) would way more than make up for the cost of the seeds.

                  With terminator ge

              • by Anonymous Coward

                I agree that there is some superstition about GMO. My main complaint is that the corporations have a history of abuse and short sighted mistakes. It is not the research itself that scares me, it is the profit focused entities that carry it out.

            • Unfortunately there is no ISO standard for common sense in Brussels.

          • by delt0r ( 999393 )

            The courts should not be used to enforce superstitions.

            Well in a democracy, that is kinda their job. If the majority have the same superstitions. Tyranny of the majority and all that. There is no legal requirement to have judgments based on science.

      • Re:*Head asplodes* (Score:4, Insightful)

        by Applehu Akbar ( 2968043 ) on Monday July 30, 2018 @11:02AM (#57032822)

        Irradiating dead organisms to preserve food is totally safe, and if we weren’t such gibbering idiots when the R-word is mentioned would eliminate the salmonella recalls we seem to be getting weekly now. But that is not the kind of irradiation this article is talking about.

        One of the standard techniques for inducing mutations in agricultural breeding is to blast crops with gamma radiation from a Cobalt-60 source. The label Luddites who won’t let us use modern genetic engineering techniques accept this as a form of conventional hybridization.

    • Re:*Head asplodes* (Score:4, Interesting)

      by Tx ( 96709 ) on Monday July 30, 2018 @09:49AM (#57032376) Journal

      Firstly, they're not talking about irradiating the food that ends up on your plate. They're talking about using radiation to increase natural mutation rates in the process of developing new strains. Crops subsequently grown from those strains are in no way "irradiated".

      Secondly, there are lots of different kinds of radiation. Sunlight is radiation, and it is mutagenic, hence skin cancer if you don't cover up. It's highly unlikely that they are using the kind of radiation that leaves things radioactive for this kind of thing, they'll be using gamma rays or weak x-rays. All your looking for is a mutation rate a few times higher than would occur naturally in sunlight, and the plants would at no stage be radioactive.

    • Our food has been trying to kill us for billions of years.
      Much of the foods we eat is because they have built up some immunity or defense against pest that would most likely eat the food faster then we can. So all foods have a degree of toxicity in them.
      GMO foods change the food so their toxins are better suited for the pests they will confront more.
      For humans it is just as safe as non gmo foods. As these toxins that are in one plant that we eat are just transferred to an other.

      • >Our food has been trying to kill us for billions of years.

        That's why I don't eat plants.

        • by Anonymous Coward

          make no doubt about it, a cow will trample you to death without a seconds hesitation, chickens would disembowel you if they were big enough. Pigs, you don't even want to know what pigs would do.

          • make no doubt about it, a cow will trample you to death without a seconds hesitation, chickens would disembowel you if they were big enough. Pigs, you don't even want to know what pigs would do.

            I don't doubt it. That's why I buy my cows and chickens from the local tree-hugging supermarket. The pig would probably ask for his belly back when he found it in my fridge. I keep the car windows rolled up in rural areas.

    • by Anonymous Coward

      "has to be safer" - why? Mutations caused by radiation happen naturally all the time, "editing" never happened before. There is nothing inherently safe about it.

      • We've edited genes on food for thousands of years. It's how we got so good a farming.

      • Mutations is just editing on a very large scale, which is the main issue here. Aka with mutation you get both the desirable traits and a bazillion others while with targeted editing you get just the desirable traits and nothing more.
    • Irradiated food is not radioactive. It's not like putting plutonium on your breakfast cereal.

      • by Nidi62 ( 1525137 )

        It's not like putting plutonium on your breakfast cereal.

        I prefer my radiation Russian style. I mix polonium in my tea.

  • by oh_my_080980980 ( 773867 ) on Monday July 30, 2018 @09:41AM (#57032338)
    “To classify gene-edited crops as GMOs and equivalent to transgenic crops is completely incorrect by any scientific definition,” said Nick Talbot, a molecular geneticist at the University of Exeter in the United Kingdom. “Precise modern gene-editing technologies allow accurate, predictable changes to be made in a genome.” http://www.sciencemag.org/news... [sciencemag.org]

    Translation:

    "No, no, no, no. It's not a new number. It's--it's--it's just a changed number. See? It's not different. It's the same, just...changed."

    Survey says:

    "A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques (i.e., a genetically engineered organism)." https://en.wikipedia.org/wiki/... [wikipedia.org]

    The question was not about the precision of the modification. It was about it being modified. You've altered the genetic material, it means you've modified it! Hand back your degree.
    • Re: (Score:2, Insightful)

      by Anonymous Coward

      A million times this ^^^

      I'm a molecular biologist / biochemist and yes CRISPR edited/modified or other way, should be treated as GMO and labeled as such. This is not because I'm against this new technology but the outcome is essentially the same and therefor the level playing field should be too. The majority of Uber opponents have nothings against Uber.. just against the lack of regulation for one type of "Taxis" but not the others.

      • Re: (Score:2, Insightful)

        by Anonymous Coward

        so then under this logic traditional crossbreeds should be labeled as GMO as well

      • Re: (Score:3, Insightful)

        by Anonymous Coward

        If CRISPR/CAS9 is treated as GMO, so should be (nuclear|chemical) mutation breeding. That is the issue here. Random mutation is acceptable (even without human trials) but carefully edited DNA is unacceptable. Something is definitely wrong!

        PS: I am Ph.D student in medical science.

        • by jabuzz ( 182671 ) on Monday July 30, 2018 @11:19AM (#57032988) Homepage

          This is the issue. So the clueless judges are saying it's find to blast away with nuclear/chemical mutation with mass genomics screening till I get the mutation I want at great expense and I don't need to label it as GMO. Noting that unless I do a full DNA sequence I will almost certainly get a bunch of other unwanted edits.

          However if I make exactly the same change using CRISPR/Cas9 ir CRISPER/Cpf1 then I have to label it GMO. That just defies common sense. Then again to expect Judges anywhere in the world to grasp what is going on is asking a lot. Well it's not really asking a lot, if they don't get it they should not be ruling on it. However the percentage of judges with any scientific training is very low.

    • by Anonymous Coward

      Have you read the article? (Nuclear|Chemical) mutation breeding [wikipedia.org] is allowed under the regulation. Meaning random mutations is considered safe but not chirurgical editing (crispr/cas9, etc.). This is insane!

  • it's funny (Score:1, Insightful)

    by Anonymous Coward

    how the corporations crying about "free market" want to take the most important feature - an INFORMED decision - away from the customers by hiding GMO content in products.

    If it's such a great thing, the customers will surely decide to buy these products themselves.

    • by Megol ( 3135005 )

      That is a completely separate matter: products containing GMO over trace levels have to be marked as such anyway. And any GMO content, trace or not, have to be approved by the EU.

    • by bws111 ( 1216812 )

      Except labeling something 'GMO' provides ZERO useful information (except to the torch-wielding villagers yelling 'kill the monster').

      What could actually be USEFUL information would be exactly what proteins, etc are present. But then if it is important to know that, why is it not important to know if the exact same proteins, etc were created by some other method?

      • What could actually be USEFUL information would be exactly what proteins, etc are present.

        How would that be useful to the average consumer?

        • by bws111 ( 1216812 )

          I didn't say is would be useful, I said it could be useful. An example would be to someone that has an allergy. On the other hand, a generic 'GMO' label is useful to nobody.

          • An example would be to someone that has an allergy.

            Labelling for common allergens (milk, eggs, soy, nuts, etc) is already a requirement.

            • Yes but that is also fucked up by the anti-GMO people. Over here in Europe every approved food additive gets assigned a E-number with the intent that people that are allergic to say "Potassium ferrocyanide" can much easily look for E536 in the ToC which is handy if #1 the ToC is small and #2 considering all the possible different ways people can spell long chemical names.

              However the very same people that are very anti GMO is also very anti additives in food and in Europe they have in particular connected th

    • how the corporations crying about "free market" want to take the most important feature - an INFORMED decision - away from the customers by hiding GMO content in products.

      Of course, it's not really an "informed decision" when all the info you have is "GMO". That's sort of like saying "we're building a new electric plant". Lot of difference between solar, hydro, coal, oil, gas, nuclear....

  • Idiots (Score:5, Insightful)

    by tsa ( 15680 ) on Monday July 30, 2018 @09:48AM (#57032370) Homepage

    I think this decision is simply idiotic. Gene editing will happen anyway anywhere on the planet and people will get rich from it. If I were the EU I'd make sure this happened within my places of jurisdiction so we benefit from it. We missed the gene editing boat in the 1990s due to a similar decision, and now we do it again. Unbelievable. This decision is clearly made to please the public who have no idea what genetic modification means, other than that it's 'scary' and 'unnatural.' This is not the way to do politics. Often what people want is not what is good for the people.

    • Re:Idiots (Score:5, Insightful)

      by Rick Schumann ( 4662797 ) on Monday July 30, 2018 @10:18AM (#57032522) Journal
      Consider this: Monsanto created GMO seeds that were protected Intellectual Property, then had to sue some farmers, in adjacent fields, who weren't purchasing them because cross polination had migrated the GMO genes into their crops. Also consider this: corporations spend many many millions of dollars developing GMO versions of plants, and since they aren't non-profits, they (and more to the point their investors and stockholders) expect timely return-on-investment -- therefore they'll rush things to market, much as Monsanto did, regardless of possible consequences. Pharmaceutical companies do this every day, having their legal departments weigh possible lawsuits due to bad reactions or death resulting from use of a drug against overall profitability. The difference here is that GMO crops are literally (as described above) the genie released from the bottle; once it's out in the wild, you're not getting it back, it's out there for good. So considering all the above, what makes you think that a profit-oriented company, armed with a device and method to allow them to modify the genes of pretty much anything, aren't going to rush something to market that may have unintended and disasterous long-term effects once it's out in Earth's biosphere? I personally used to worry about all the GMO crops that were being introduced but I don't waste the energy anymore because it's too late now, they're out there, and if in another 20 or 30 years we see some terrible unintended side-effect of the gene editing that causes a major disaster, then what are we to do? Meanwhile the EU is being smarter about it than our own legislators here in the U.S. have been (or less corrupted by corporate influences?) and are thinking about the possible long-term effects, and doing what they can to make it as safe as possible without totally stifling innovation. The fact that some bad actors in non-EU countries may do reckless things with the technology is irrelevant, and at best we can hope that there aren't scientists out there who are willing to be totally irresponsible and reckless with the technology themselves. It may all be for nothing but I applaud the EU for being careful where it counts.
      • Re: (Score:3, Informative)

        by Cyberax ( 705495 )
        Monsanto hasn’t sued farmers who simply got some cross-pollinated crops. Not once. Not a single time.
        • by Anonymous Coward

          From a source: [npr.org]

          The idea, however, is inspired by a real-world event. Back in 1999, Monsanto sued a Canadian canola farmer, Percy Schmeiser, for growing the company's Roundup-tolerant canola without paying any royalty or "technology fee." Schmeiser had never bought seeds from Monsanto, so those canola plants clearly came from somewhere else.

          • He testified that he then harvested that crop, saved it separately from his other harvest, and intentionally planted it in 1998

            This is a little different from just being cross-pollinated.

      • by tsa ( 15680 )

        If you were right GMOs would not be sold here, but as far as I know they are. We also have much stricter legislation for food and medication. And GMOs have been in use for over twenty years now and we still don't see many, if any, negative effects yet.

        I think gene modification is a great technology that should be exploited, but there should be strict rules on how to handle it. Just outright forbidding it, like the EU has done now again is putting your head in the sand.

      • That’s a legal problem that has nothing to do with GMO technology. Plant patents have been around, and have been litigated over, for the last hundred years.

      • by bws111 ( 1216812 )

        Plants have been patentable since the 1930s. The ability to patent seeds has nothing to do with GMO.

      • Re:Idiots (Score:5, Informative)

        by Tinsoldier314 ( 3811439 ) on Monday July 30, 2018 @12:02PM (#57033350)

        The case is widely cited or referenced by the anti-GM community in the context of a fear of a company claiming ownership of a farmer’s crop based on the inadvertent presence of GM pollen grain or seed.[25][26] "The court record shows, however, that it was not just a few seeds from a passing truck, but that Mr Schmeiser was growing a crop of 95–98% pure Roundup Ready plants, a commercial level of purity far higher than one would expect from inadvertent or accidental presence. The judge could not account for how a few wayward seeds or pollen grains could come to dominate hundreds of acres without Mr Schmeiser’s active participation, saying ‘...none of the suggested sources could reasonably explain the concentration or extent of Roundup Ready canola of a commercial quality evident from the results of tests on Schmeiser’s crop’" – in other words, the original presence of Monsanto seed on his land in 1997 was indeed inadvertent, but the crop in 1998 was entirely purposeful.[27]

        https://en.wikipedia.org/wiki/... [wikipedia.org] If anyone wants more information on the case he's citing, it's well documented on wikipedia.

        • " it was not just a few seeds from a passing truck". Really it's ok for a few seeds from a passing truck to contaminate your non-GMO crop? If you have a problem with that, perhaps because you're trying to grow crops that rely on organic/biodynamic principles where the soil biology is important as opposed to pouring pesticides/herbicides onto it, then you really just need to get over it. Hey we're having a gun fight over here and yeah there might be a few stray bullets but you just need to get over it.
          • The court did not say that it would have been OK if a few seeds from a passing truck had contaminated his field, that remark was simply to state that this was not the case (since that is what Schmeiser claimed had happened).
      • by DRJlaw ( 946416 )

        The difference here is that GMO crops are literally (as described above) the genie released from the bottle; once it's out in the wild, you're not getting it back, it's out there for good. So considering all the above, what makes you think that a profit-oriented company, armed with a device and method to allow them to modify the genes of pretty much anything, aren't going to rush something to market that may have unintended and disasterous long-term effects once it's out in Earth's biosphere? I personally u

  • by swillden ( 191260 ) <shawn-ds@willden.org> on Monday July 30, 2018 @09:57AM (#57032424) Journal

    This decision makes no sense. First, there's a ridiculous amount of respect given to "natural" processes, as though they're anything other than purely random. But the really dumb part is considering targeted, controlled editing to be more dangerous than dousing plants in mutagenic chemicals and/or radiation in order to accelerate selective breeding. In the former case, we may not have a perfect understanding of what the change is going to do, but in the latter case we have no idea what the changes even are, we just know that there are orders of magnitude more of them than normal.

    It's like deciding that it's safer to do an appendectomy with a shotgun than with a scalpel.

  • by Anonymous Coward

    If the GMO industry actually tried to produce useful strains, instead of the usual "let's make it more resistant to poison so it's the only thing that grows after soaking soils in chemicals", it may find more sympathetic European ears

    As it is no one here except for Bayer actually wants to help the agro industry poison European soil and European people. All for a few years of improved yields, that will be negated as soon as pests grow poison-resistant, while humans get sick long-term (because humans do not r

    • by bws111 ( 1216812 )

      However, according to the EU, if you can create the same resistance to the same poison by bombarding some seeds with radiation or chemicals, then it is perfectly safe.

  • Will be interesting to see how they will regulate it,,for GMO you can easily test for the transgenic protein. Gene editing for the removal of an existing protein will require testing for the absence of that protein,,more difficult, especially in mixed grain exported commodity barge, trains, trucks,etc. Like testing for Organic,,can't be done in a lab
  • https://www.nytimes.com/2004/1... [nytimes.com]

    The European Commission has long attempted to justify its strict health and environmental regulations as necessary to protect the public from uncertain risk associated with genetically modified crops. The World Bank report debunks this myth and offers empirical evidence of the commission's true motives.

    What is really behind the commission's stringent regulations is European industry's comparative disadvantage in the use of genetically modified, or GM, crop technology. In dra

  • Transgenic sequences would stick out, but if you CRISPR away just a few things here and there, and pass it off as conventionally mutated, it doesn't seem to me they'd be able to tell very easily. It'd be unethical, but seems like the type of thing a tiny LLC could perpetually license to a big firm before inexplicably going bankrupt and burning down... if only they'd thought to put their development documents in offsite archive...
  • "must go through the same lengthy approval process as traditional transgenic plants."

    Yeah!

    CRISPER is just as dangerous if not more so.

Truly simple systems... require infinite testing. -- Norman Augustine

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