Might CRISPR prove to be regulatory arbitrage?

by on April 20, 2016 at 2:34 am in Current Affairs, Law, Science, Uncategorized | Permalink

Last week, the U.S. Department of Agriculture (USDA) confirmed that it will not regulate the cultivation and sale of a white-button mushroom created using CRISPR

In this case, no foreign organism’s genetic material was introduced into the food, and that makes all the difference. If Yang had tackled mushroom browning by adding bits of genetic code from another organism, it would have been subject to USDA scrutiny as other non-browning produce has been. Until recently, genetic modification required the insertion of foreign viruses or bacteria, but CRISPR is more advanced than that. Because of that loophole, it’s not under the USDA’s jurisdiction. The EPA only regulates GMOs designed for pest control, and the FDA considers all GMOs to be safe. That leaves this non-browning mushroom cleared for take-off.

Scientists are excited. Anti-GMO advocates are disturbed. The public will probably continue to be more confused than anything else.

Here is the Rachel Feltman piece.  For the pointer I thank Cleveland Cavaliers fan Philip Wallach.

1 Mark Thorson April 20, 2016 at 3:19 am

I dispute you can be an “anti-GMO advocate”. You can be a “GMO opponent” or an “anti-GMO activist”, but you’re not an advocate for anything.

2 carlolspln April 20, 2016 at 7:27 am

Like to overdose on glyphosate with your ‘Round Up Ready’ grain crops?

http://www.scientificamerican.com/article/weed-whacking-herbicide-p/

You first.

3 Brian April 20, 2016 at 8:02 am

That seems like a problem with Herbicide use, not GMOs. And yes I know how they are related, but this really is about what they are spraying, not the genetic makeup of the corn. If they aren’t using roundup, they’re using a different herbicide.

And Yes, I am happy to eat round up ready corn. I do it all the time.

4 MC April 21, 2016 at 12:28 am

+1

5 Daniel in VA April 20, 2016 at 8:12 am

I agree with Brian, if you think that glyphosphate is dangerous to consumers or workers or harmful to the environment, imposing controls on that directly makes more sense. Genetically modifying organisms per se is orthogonal to chemical safety (except where the organism is modified to produce the substance).

6 Nathan W April 21, 2016 at 1:34 am

Well, “orthogonal” is an overstatement, but I agree that they should be treated as different issues from the regulatory perspective.

7 Daniel Weber April 20, 2016 at 10:56 am

Let’s find the MSDS.

https://www.lakerestoration.com/pdf/GlyphosateMSDS.pdf

You shouldn’t inhale glyphosate, but it’s not in that form by the time it reaches consumers. You can even drink small amounts of it, so trace amounts left on food is of no concern.

8 carlolspln April 20, 2016 at 5:03 pm
9 Daniel Weber April 21, 2016 at 10:48 am

There are hundreds of articles on PubMed about the toxicity of glyphosate. You are going back to 2004 to find the worst you can.

https://www.ncbi.nlm.nih.gov/pubmed/23480780
meta-study showing no genotoxic risk in normal human encounters

https://www.ncbi.nlm.nih.gov/pubmed/23286529
meta-study saying rabbits needs 150mg/kg/day to get sick; in a human, this is well over the “one mouthful is safe” in the MSDS

https://www.ncbi.nlm.nih.gov/pubmed/24762670 shows occupational exposure, but of course this is very different from exposure left on the food

https://www.ncbi.nlm.nih.gov/pubmed/22683395
meta-study showing no evidence of a cancer risk from glyphosate

https://www.ncbi.nlm.nih.gov/pubmed/21798302
meta-study showing no evidence of non-cancer health risks from exposure glyphosate

At this point in the thread, I need to point out

“The bullshit asymmetry: the amount of energy needed to refute bullshit is an order of magnitude bigger than to produce it.”

10 Daniel Weber April 21, 2016 at 12:24 pm

I have a reply in moderation showing several meta-studies, all on PubMed, that glyphosate is same on the consumer level.

11 Nathan W April 20, 2016 at 9:11 am

To advocate for a position. Like, a “poverty advocate” doesn’t advocate for more poverty, they advocate for issues about poverty. Anyways, I think the principle of letting people defines themselves however they want should apply.

12 kimock April 20, 2016 at 3:20 am

“Douglas Gurian-Sherman, with the Center for Food Safety, a nonprofit group that has campaigned against genetically engineered crops, says the lack of formal regulatory review of gene-edited crops is disturbing. For one thing, it makes it difficult to know exactly what’s been done to the crop. “The company can just keep its data to itself,” he says.”

That sounds reasonable. But the Center for Food Safety is never satisfied with mere regulation. They seek to prohibit all new food technologies.

13 carlolspln April 20, 2016 at 7:24 am

“But the Center for Food Safety is never satisfied with mere regulation. They seek to prohibit all new food technologies”

That’s right.

There’s that ‘wonder’ fourth [4th] food group that they’ve been suppressing since 1955.

14 Nathan W April 20, 2016 at 9:12 am

“They seek to prohibit all new food technologies.”

Care to explain your perspective, perhaps including concrete examples, or strong evidence of slippery slopes that they have been sliding down?

15 kimock April 20, 2016 at 9:53 am

Perusing their website http://www.centerforfoodsafety.org/ for a few minutes yielded these recent activities regarding food technology (I only selected based on newness, and focus on technology):

* “A broad coalition of environmental, consumer, and commercial and recreational fishing organizations today sued the U.S. Food and Drug Administration (FDA) for approving the first-ever genetically engineered (GE) food animal, an Atlantic salmon engineered to grow quickly”

* “Victory! Latest Industry Effort to Block GMO Food Labeling Defeated in Senate”

* “GE MOSQUITOES? TELL FDA NO!”

* “Sign the Petition to Tell Orville Redenbacher to Stop Killing Bees (through pesticides)”

* “Monarch butterflies are one of the most beautiful and iconic insects in the world, but the use of herbicides like Monsanto’s Roundup on genetically engineered crops is destroying a significant portion of their breeding habitat in North America”

“TELL FOOD COMPANIES TO REJECT THE GE APPLE!”

“CFS Lawsuit Challenges FDA’s Approval of Genetically Engineered Salmon”

“Advocacy Groups (including CFS) Call for Halt to Open Air Field Trials of Genetically Engineered Moths”

“Your Right to Know: FDA Poised to Weaken Labeling on Food Irradiation”

“That threat is nanotechnology in food products.”

Nowhere did I see any evidence of support for a new food technology, nor satisfaction with current regulation. From this, and their rhetoric, I infer that only prohibition would satisfy them.

Perhaps I didn’t search long enough. You are welcome to find evidence where CFS supports a new food technology or is satisfied with the level of regulation thereof. But I have followed their work for more than 15 years, and know some staff members personally. Based on this, I doubt that your search will be successful.

16 Nathan W April 21, 2016 at 1:55 am

My impression is that they want to be more attentive to the risks of new food technologies, not to ban them as a matter of principle.

I disagree with several of their campaigns, but there is indeed scientific legitimacy to each of the arguments. Say, on salmon, some people are concerned that this could threaten natural stocks, but others simply don’t care at all about natural stocks. Personally, I care a lot about natural stocks, but think that careful deployment of the new technologies could do more to protect the natural stocks than preferring the status quo.

17 kimock April 21, 2016 at 2:56 am

I wish that they “wanted to be more attentive to the risks of new food technologies, not to ban them as a matter of principle” but my experience is otherwise.

The legitimacy of their arguments vary widely, from zero to quite serious.

18 Nathan W April 22, 2016 at 1:18 am

“The legitimacy of their arguments vary widely, from zero to quite serious.”

I think that accurately represents the situation.

19 Floccina April 22, 2016 at 4:11 pm

* “GE MOSQUITOES? TELL FDA NO!”

It is hard for me imagine the rational for that one.

20 David Brown April 20, 2016 at 6:27 am

No, it isn’t regulatory arbitrage. People’s discomfit with GM is due to the concept of non-plant genetics in their food.

Is it even possible to prove a plant has been “CRISPRed?” Breeding can change genetics in functionally identical ways.

21 RustySynapses April 20, 2016 at 10:39 am

Well, in my case I’m uncomfortable with it because we’re getting better at directly tampering with something that we don’t really understand – a very complicated system that evolved over millions of years. Non-plant genetics may be worse (who knows). We don’t know so many things about nutrition (or rather, we are busy figuring out whether so much we *knew* is wrong – sugar is just empty calories, a calorie is a calorie, all fat is bad, saturated fat is bad, etc.) – yet somehow, we understand all of the implications of what we’re doing, and *know* GMO is safe. Yeah, right, and trans fats were an “improvement” over saturated fat – although with genetics, it may not be so easy to undo.

22 David H. April 20, 2016 at 4:53 pm

“…directly tampering with something [gene sequences] that we don’t really understand”
Yeah, we’ve done that as long as sex existed, except that left everything to chance. Leaving less to chance isn’t worse.

23 RustySynapses April 21, 2016 at 1:32 pm

Intentional action is always better than chance? Even if well-intentioned, and ignoring that the range of outcomes via crispr seem a lot less constrained than sexual reproduction (at least factoring in probability – it may be that random mutation plus sexual reproduction could reach any crispr outcome), that’s a pretty bold statement. It’s a little bit like Chesterton’s fence – we think we know the purpose (effect) of the gene, and maybe we do, but we really don’t understand the whole system or the range of possible future interactions/effects. Plus, you could imagine all kinds of issues when a technology that allows choice/selection gets applied by people/groups that aren’t coordinating – e.g. risk of lack of diversification (to take a ridiculous extreme, suppose everyone uses crispr and selects male children). Of course, people could do accidentally stupid things before crispr (I forget how killer bees were created – I assume some sort of cross breeding), but this opens up a lot more possibilities.

24 Bryan Hann April 24, 2016 at 11:44 am

We also don’t know of burning fuel releases gasses that might lead to catastrophic climate change, so lets not tell anyone about your discovery of fire, son of Ugh.

Yeah I know, I’m strawmanning. But it’s not clear to me how to make principled distinctions.

25 Nathan W April 20, 2016 at 6:37 am

It’s interesting that some product categories must prove that they are safe (or at least not too dangerous) before they go to market, but others can go to market with no oversight and it is contingent on representatives of consumer interest to prove significant ill effect before the product can be taken off the market.

26 dan1111 April 20, 2016 at 10:49 am

In the U.S. GMOs must be proven safe by passing tests to show they are equivalent to an existing established food product: https://en.wikipedia.org/wiki/Substantial_equivalence
This includes toxicology and nutritional analysis to show that the GMO isn’t meaningfully different. Plus there has been a large amount of research into GMOs generally, which has not uncovered any evidence that they are harmful.

I’m not sure what a good measure of being proven safe would look like to you?

27 Nathan W April 21, 2016 at 8:30 am

Then why so resistant to GMO labelling? If you can prove its safe, then market the evidence. I think the resistance to labelling itself is the main source of suspicion. If some people will irrationally refuse to buy such products, then it’s the job of the producers to market its safety with convincing scientific demonstrations.

28 dan1111 April 22, 2016 at 7:28 am

“Then why so resistant to GMO labelling?”

This has been covered ad nauseaum.

1) A government requirement to label something creates the impression that it is unsafe.

2) Every regulation has a cost, and so regulations shouldn’t be enacted without a compelling reason. It is easy to say “labels are trivial and shouldn’t cost much” but in fact this would cost millions and millions of dollars across the food market. In particular, the requirement would be onerous for foods with a lot of component ingredients. Like most regulations, the burden would fall disproportionately on small businesses who have fewer resoruces to deal with this.

3) “Some people want the information or want to avoid GMO foods” is not a compelling reason for mandatory labelling. This need can be met by companies voluntarily labelling to meet demand in the free market. Indeed, this has already happened and there are “GMO free” foods on the market if that is what you want.

You may not agree with these points, but I’m sure you are familiar with them, since they have been discussed quite a bit on this blog.

29 Sanjay April 20, 2016 at 8:00 am

No, my impression has been that FDA and others are working hard to patch this hole, as they should, pronto. (note: I’m fine with GMOs and deeply admire many of my colleagues who went into plant molbio in the hopes they could feed people.) So far industry has been OK about testing and demonstration of equivalency anyway but it’s probably a good idea to have some regulatory tool or lever you can use in case something weird happens, and I suspect the very presence of that lever would encourage more industry in this area by giving folks some oversight they can point to.

Not that this particular GMO isn’t a monstrosity. The market, far as I can tell, is el cheap-o restaurants that want to slice your salad up a day or two in advance. But that just makes the product an aesthetic nightmare not a health one.

30 Bill April 20, 2016 at 8:15 am

Agreed. You do want some testing and you want to consider externalities as well. Say you are a farmer next to another farmer who has a GMO crop and it pollinates your crop. Let’s say you are a beekeeper and the GMO product affects the local aviary. No harm in testing to answer these questions before releasing.

I, personally, would like a tomato as large as a pumpkin, and a cucumber as large as a baseball bat.

Imagine the fun you could have.

31 Bill April 20, 2016 at 8:20 am

In case you didn’t notice, an aviary is for birds; an apiary is for bees.

But, maybe I didn’t make a mistake.

What if the GMO affected bees grow as big as birds. Then what.

32 David Brown April 20, 2016 at 8:33 am

A monstrosity… because the food stays fresh longer? Would any human on the planet 100 years ago agreed with that statement?

33 Nathan W April 20, 2016 at 9:15 am

He was pretty clear that he doesn’t think it’s a monstrosity. Most GMO stuff has basically nothing to do with food staying pleasant colours for longer.

34 Cliff April 20, 2016 at 10:57 am

He was pretty clear that he DOES think it’s a monstrosity. “NOT that this particular GMO ISN’T a monstrosity.”

Anyway does the food actually stay fresh longer? I don’t think so, it just doesn’t turn brown.

“Most GMO stuff has basically nothing to do with food staying pleasant colours for longer” So what??

35 Nathan W April 21, 2016 at 8:36 am

Ah, I misread the “isn’t” as “is”. Congrats. Your first correction that wasn’t nearly 100% off base.

On the last point, it’s because David suggests that GMO is the cause of foods being fresher. Perhaps we’re in agreement that this is irrelevant. What I’m pointing out is that freshness is, to date, basically irrelevant to the discussion of GMOs.

36 prior_test2 April 20, 2016 at 11:23 am

‘Most GMO stuff has basically nothing to do with food staying pleasant colours for longer.’

Well, except the very first commercially offered and approved GMO product involved exactly that as an important aspect – ‘Through genetic engineering, Calgene hoped to slow down the ripening process of the tomato and thus prevent it from softening, while still allowing the tomato to retain its natural colour and flavour. The tomato was made more resistant to rotting by adding an antisense gene which interferes with the production of the enzyme polygalacturonase. The enzyme normally degrades pectin in the cell walls and results in the softening of fruit which makes them more susceptible to being damaged by fungal infections. Some unmodified tomatoes are picked before fully ripened and are then artificially ripened using ethylene gas which acts as a plant hormone. Picking the fruit while unripe allows for easier handling and extended shelf-life. Flavr Savr tomatoes, on the other hand, could be allowed to ripen on the vine, without compromising their shelf-life. The intended effect of slowing down the softening of Flavr Savr tomatoes would allow the vine-ripe fruits to be harvested like green tomatoes without greater damage to the tomato itself. The Flavr Savr turned out to disappoint researchers in that respect, as the antisensed PG gene had a positive effect on shelf life, but not on the fruit’s firmness, so the tomatoes still had to be harvested like any other unmodified vine-ripe tomatoes.’ https://en.wikipedia.org/wiki/Flavr_Savr

Really, GMOs that reach the marketplace are about market demand for profit, not consumer demand for better food.

37 Cliff April 20, 2016 at 2:07 pm

So what?

38 carlolspln April 20, 2016 at 4:53 pm

@ Cliff “So what”?

Americans eat shitty food & don’t know any better.

Nor care.

http://www.foodsafetynews.com/2015/12/chipotle-e-coli-numbers-drop/

39 Nathan W April 21, 2016 at 8:40 am

“Some unmodified tomatoes are picked before fully ripened”

Not that huge of a deal, but FYI, in commercial tomato picking, the method is to pick ANY tomato (not some) with the vaguest hint whatsoever that any redness is coming. Then it “ripens” on the way to market. Because of how much more careful you have to be with vine ripened tomatoes, and they have to be sourced locally, they are usually about double the price.

40 anon April 20, 2016 at 9:27 am

Sounds shady. Chipotle has enough trouble with same day salads.

41 Axa April 20, 2016 at 8:08 am

Case A): adding a gene from another organism requires regulations , Case B) shutting down a gene from the original organism DNA….out of regulation

Intelligent people is playing trial & error to shutdown (inactivate) individual gene sequences to find which “switch” turns off abnormal cell growth A.K.A. cancer. http://scienceblog.cancerresearchuk.org/2016/02/01/crispr-gene-editing-new-chapter-in-cancer-research-or-blot-in-the-ethical-copybook/

If DNA modification involves only cutting, scientists will work with less regulations…perhaps. This is awesome =)

42 Dylan April 20, 2016 at 8:08 am

As I understand it Arctic Apples do not use foreign genetic material either.

43 Jon April 20, 2016 at 8:53 am

The anti GMO crowd is leftist anti science anti technology nonsense. Nonetheless there are some risks in that safe organisms can be genetically altered to produce pesticides that are harmful to people.
However that might be accomplished even with conventional breeding. Some well known fruits are bred from toxic plants. Canola oil is from rapeseed genetically modified to remove toxic fatty acids by conventional means.

44 Nathan W April 20, 2016 at 9:17 am

It sometimes seems that way. But what they are actually asking for is more science to address potential concerns before going ahead. That sounds pretty pro-science, not anti-science to me, no matter that the average anti-GMO person I think is not highly scientifically literature (which applies to most people …)

45 jthomas April 20, 2016 at 10:41 am

LOL, “what they are actually asking for is more science”. Nathan, you make Orwell proud.

46 Nathan W April 21, 2016 at 8:49 am

Well, anyways, those are the only positions that I deem to be credible among people who are skeptical about GMOs.

It’s funny how a lot of the people who are willing to reject 97%+ consensus among climate scientists are often the very same people who are wiling to unquestioningly accept a significantly lower amount of agreement among geneticists, ecologists, etc. when it comes to GMOs.

I find the sort of position that reads “I don’t see causes for immediate concern, but it doesn’t seem that companies producing GMOs have any interest whatsoever in serious research for the following possible concerns …” to be fairly credible. Which is basically the position of asking for more science.

Of course, if you only listen to the extreme 2% or 10% of activists, then it’s easy to strawman the whole thing.

47 Daniel Weber April 20, 2016 at 10:59 am

Without addressing your specific point, your words are how Jenny McCarthy describes her approach to vaccines.

48 Cliff April 20, 2016 at 10:59 am

No science would ever be enough to satisfy them. This is a settled issue scientifically. There is nothing about GMO per se that is in any way dangerous. Individual products need to be proven safe and are.

49 Nathan W April 21, 2016 at 9:07 am

That’s an extremely dogmatic and unscientific position. It can only be deemed safe on a case by case basis.

For a ridiculous example, I could cite the possibility to intentionally create a GMO corn that would cause cancer.

The main concern that I take credibly is that we may lose natural cultivars by introduction of GMO materials into wild species or other cultivated crops.

The main counterargument against anti-GMO people, I think, is that they would mostly be OK with a breeding program that took 30 years to get the same result, but not the engineered product that achieves the same result.

50 anon April 20, 2016 at 9:33 am
51 8 April 20, 2016 at 9:53 am

This may represent successful indoctrination rather than knowledge acquisition. I’m not anti-GMO, but I suspect most of what is called “information” is probably propaganda.

52 anon April 20, 2016 at 10:04 am

I don’t totally agree with this piece but

Risk Perception Is Always Irrational.

The large number of people (57% of adults) distrusting “a new kind of food” are reacting in a very instinctive way. Umpty ump million years of putting things in our mouths where losers died.

53 Nathan W April 20, 2016 at 10:16 am

It’s pretty understandable, given that the GMO producers are not exactly forthcoming with information. Who’s to blame for the low information situation?

54 anon April 20, 2016 at 10:23 am

It is interesting that college grads and those with scientific knowledge are most accepting of GMOs, but even those only break about 50:50.

You have to give up on natural intuition and trust domain expertise, the NSF recommendations, right? That’s hard.

Just ask the usual suspects who hate on scientists and their pocket lining conspiracies.

55 8 April 20, 2016 at 9:45 am

Imagine Idiocracy (the regulators) crossed with 12 Monkeys (the lone geneticist). There’s no regulating what is coming.

56 Nathan W April 20, 2016 at 10:17 am

In which case, we probably need at least twice as much regulation as anyone was already thinking of.

57 Cliff April 20, 2016 at 11:01 am

I guess you missed this part? “There’s no regulating what is coming.”

58 Nathan W April 21, 2016 at 9:14 am

There is no such thing as something that cannot be regulated. However, there are many things where regulation may not be desirable.

Like, if the NSA can monitor basically anyone based on the flimsiest of reasons (or perhaps no reason at all, although that’s technically illegal), even mandating that the companies both have to turn over information and are legally required to not disclose that they were forced to do so. I’m pretty sure it would be possible to monitor and/or regulate activities related to lone geneticists, which are a rather more identifiable group.

Even if there were “home-based CRIPR kits” on the market, a simple regulation which said that only authorized researchers could access such a kit would be trivially easy to apply. Which is not the same as arguing whether or not such a regulation is itself desirable (I think it would be desirable).

59 dan1111 April 22, 2016 at 7:30 am

“There is no such thing as something that cannot be regulated.”

Only true in the trivial sense that you could make a regulation that states anything.

There are plenty of things that you cannot practically regulate. For example, thoughts.

60 stephan April 20, 2016 at 10:57 am

The general public is not too scientifically literate

https://www.washingtonpost.com/news/volokh-conspiracy/wp/2015/01/17/over-80-percent-of-americans-support-mandatory-labels-on-foods-containing-dna/

More seriously : There seem to be ways to prevent gene leakage in GMOs by “confering metabolic dependence on non-standard amino acids for survival. The resulting GMOs cannot metabolically bypass their biocontainment mechanisms using known environmental compounds, and they exhibit unprecedented resistance to evolutionary escape through mutagenesis and horizontal gene transfer.”

http://www.the-scientist.com/?articles.view/articleNo/41954/title/GMO–Kill-Switches-/

and paper by Church et al

http://www.nature.com/nature/journal/v518/n7537/full/nature14121.html

61 Chip April 20, 2016 at 4:21 pm

I’m not aware of GMOs causing a single death in more than 20 years.

WHO says 250 million preschool kids suffer from vitamin A deficiency – it’s lacking in their stale meal of rice – and that providing vitamin A could prevent one-third of all under 5 deaths, saving 2.7 million kids a year.

62 carlolspln April 20, 2016 at 5:24 pm

Face it, Chip it ain’t ever gonna happen.

Monsanto has screwed GMO for the next century by its furtive conduct, secrecy and klutzy attempts to monopolise seeds.

UPSHOT: they’d fuck up a wet dream. All you have to do is lie there.

http://articles.mercola.com/sites/articles/archive/2013/09/10/monsanto-bt-corn.aspx

63 Nathan W April 21, 2016 at 9:23 am

Perhaps 10% of the translating and editing projects I work on have child nutrition in developing countries as one of the major themes. In recent years, discussion of efforts to pick this low hanging fruit are virtually ubiquitous, even when they are not the specific issue being discussed.

I’m not anti-GMO. But considering that no one actually knows who is consuming GMO food because it’s not labelled, we’re really in a situation of zero information, which does not allow us to conclude anything whatsoever about whether deaths were caused by GMOs (excluding the suicides of farmers in India after some pretty horrible lawsuits by Monsanto some years ago). An absence of information draws us to a non-conclusion, not a conclusion.

And, for the record, I do not actually believe that GMOs presently on the market are very likely at all to pose health risks. I’m just not willing to dismiss out of hand the more credible/plausible concerns that some folks raise.

64 Floccina April 22, 2016 at 6:07 pm

I recommend this blog to anyone interested in GMOs.

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