Dec 26 2012

The hazards of GM foods: patent protection and international relations

Writing in Slate, Fred Kaufman takes a fresh look at the controversies over genetically modified (GM) foods.  Forget the other issues, he says.   Pay attention to patents:

GM foods’ effect on health is uncertain, but their effect on farmers, scientists, and the marketplace is clear. Some GM foods may be healthy, others not; every genetic modification is different. But every GM food becomes dangerous—not to health, but to society—when it can be patented. Right now, the driving force behind the development of new genetic crop modifications is the fact that they possess the potential to be enormously profitable….

That brings me to the GM salmon, in particular AquAdvantage brand engineered to grow faster and bigger than wild salmon.

Last Friday (always a good time to release something controversial), the FDA let loose its draft environmental assessment on the GM salmon.  The draft finding of “no effect” is now open for comment.

I find the draft statement remarkable for two reasons.

  • It is dated May 4, 2012, suggesting that it was considered too political to release before the election.
  • It applies only to production of GM salmon outside the United States.

The FDA had already ruled that the salmon are safe to eat:

With respect to food safety, FDA has concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon. Further, FDA has concluded that no significant food safety hazards or risks have been identified with respect to the phenotype of the AquAdvantage Salmon.

With respect to environmental impact, the FDA says:

FDA preliminarily concludes that the development, production, and grow-out of AquAdvantage Salmon under the conditions proposed in the materials submitted by the sponsor in support of an NADA [New Animal Drug Application], and as described in this draft EA [Environmental Assessment], will not result in significant effects on the quality of the human environment in the United States.

AquAdvantage is not intended to be grown in the United States.  It is being raised on Prince Edward Island in Canada and in Panama and will be processed in Panama.

Under the proposed action, AquAdvantage Salmon would not be produced or grown in the United States, or in net pens or cages, and no live fish would be imported for processing.

…As the proposed action would only allow production and grow-out of AquAdvantage Salmon at facilities outside of the United States, the areas of the local surrounding environments that are most likely to be affected by the action lie largely within the sovereign authority of other countries (i.e., Canada and Panama).

Because NEPA [the National Environmental Policy Act] does not require an analysis of environmental effects in foreign sovereign countries, effects on the local environments of Canada and Panama have not been considered and evaluated in this draft EA except insofar as it was necessary to do so in order to determine whether there would be significant effects on the environment of the United States….

In addition, social, economic and cultural effects of the proposed action on the United States have not been analyzed and evaluated because the analysis in this draft EA preliminarily indicates that the proposed action will not significantly affect the physical environment of the United States.

If I am getting this right, the FDA is saying that since the salmon is being raised elsewhere, it’s OK to produce it.

This report is generally interpreted as opening the door to marketing of GM salmon within the United States, and soon.

Will it be labeled as such?  I suppose that too is up to Canada and Panama.

Revisit patent protection anyone?

  • Mary

    Funny, I was just reading that article on how key the patents and monopolies were for the Orphan Drug Act, which led to a whole wave of important, but small-market, treatments for rare diseases.

    http://www.washingtonpost.com/blogs/wonkblog/wp/2012/12/25/jack-klugmans-secret-lifesaving-legacy/

    Sometimes patents actually do encourage progress. Teh irony.

    But that said, I’m delighted to see how eager everyone seems to be for the first GMOs to go off patent, and for farmers to be able to pull them out of the commodity stream an use them without any constraints. It really surprises me to see foodies jump on that upcoming SCOTUS case that way.

  • Foster Boondoggle

    Kaufman’s article was incoherent, as commenters at Slate observed right away. But what’s your concern here? First of all, what’s the FDA’s mandate? I thought their concern was safety and suitability for human consumption. Are they now supposed to be global environmental police where our food supply is concerned? I mean, it would be great to have an international organization that had that mandate (though the ones I know of, like the fishing quota organizations, seem to be thoroughly coopted by the people they’re supposed to regulate). But that’s way beyond what we can reasonably expect the FDA to do.

    So, again, what’s the concern here? The company seems to have gone out of their way to make sure these fish can’t survive outside the tanks where they’re to be raised. (Honestly, I can’t see how this can ever be profitable, but never mind that.) And all they’ve done to these fish is to give them an always-on growth hormone gene. If that was competitively advantageous to the fish, they’d already have an always-on growth gene by way of lucky random mutation of the regulatory region. So the fear that these things are going to escape and take over the sea is just a scary fantasy.

    Regarding health and quality: are you OK with farmed salmon, as long as it doesn’t have its growth hormone gene switched to always-on? “Natural” farmed salmon raised on food pellets made (unsustainably) from other fish? If you don’t want to ever consume this stuff, stick to buying salmon labeled as wild. (And hope that the label is correct – a huge issue, as you already noted a few days ago.)

    Your posts on GMOs seem to assume that everyone who comes here already agrees with whatever agenda you have, and that no argument or evidence is required to justify a presumptively true conclusion.

  • Joe

    Quote: “First of all, what’s the FDA’s mandate? I thought their concern was safety and suitability for human consumption.”

    Under NEPA [the National Environmental Policy Act], the FDA has to release an environmental assessment [EA] to determine whether or not “a major federal action significantly affects the environment.” Licensing of the fish for consumption is almost certainly a major federal action regulated by NEPA.

    Here, the FDA ended their EA with a FONSI [Finding of no significant impact], basically based on only licensing the fish grown not in the United States. If the fish were grown in the US there would probably be enough impact to require a Environmental Impact Statement (a very costly look at the actual impact).

    As far as the argument that NEPA only applies to United States’ environment, that is somewhat up in the air and will depend on the purpose, intent, and wording of the Act itself. It’s not something that has a clear answer at 10AM in the morning.

    As far as the argument that this licensing will not significantly affect the US’s environment, I would also say that’s arguable and depends on how long one is willing to go on the cause and effect chain; will this licensing affect native populations of fish harvested and farmed fish in the United States? Likely yes, but perhaps this is either not significant enough or too disconnected from the Act itself to warrant an Environmental Impact Statement (the expensive one). NEPA cares about “the quality of the human environment” so that cuts towards the FDA perhaps being right here.

    I don’t know if you actually wanted someone to answer your question or if you just wanted to blowhard, but here you go.

  • Foster Boondoggle

    That’s interesting, actually. But you say “Will this licensing affect native populations of fish harvested and farmed fish in the United States? Likely yes…” What’s the basis for that conclusion, other than some broad assumption of impact that would apply equally to any other – e.g., non-GMO – fish farming practice?

    I’m still not clear on what exactly Dr. Nestle is concerned about. So many of the GMO posts just have the tone that GMOs are presumptively bad, and that no actual fact-based arguments need to be offered to justify the anti- viewpoint.

    I looked back to her 2010 post on this fish and found a series of comments questioning why a voluntary labeling regime (i.e., “GMO-free”) would not be both appropriate and sufficient. But she never seems to respond to comments, so I don’t know what the counterargument is.

  • http://www.thehealthyeatingguide.com/ Scott @ The Healthy Eating Guide

    Interesting POV, Foster. I’m personally opposed to GMO foods, so I readily admit my bias toward immediately having a negative view of the FDA’s decision. But, I think a lot of your points make sense and are well articulated. The FDA did what was asked of it, within the limits of its power and jurisdiction.

  • Michael Bulger

    I’m confused by this sentence: “If that was competitively advantageous to the fish, they’d already have an always-on growth gene by way of lucky random mutation of the regulatory region.”

    Was that supposed to be a serious statement, or an attempt at humor?

  • Mary

    @Michael Bulger: that isn’t humor, that’s biology. That fish has a niche with a certain life cycle, and it down regulates growth for part of the time.

    A lot of people who don’t understand that could benefit from reading this piece about the “trojan gene”. The author of that tries to straighten out some people who are misusing that concept, and it might address your confusion.

    http://latimesblogs.latimes.com/greenspace/2010/11/ge-salmon-foes-cite-trojan-gene.html

  • Michael Bulger

    What I was referring to was “Foster’s” inference that an always-on growth gene would have randomly mutated itself into existence if it was advantageous to salmon. That’s nonsense.

    But thank you for the article, it was indeed helpful to read about the importance of courtship rituals in salmon.

  • Mary

    Well I understand what he was saying, but he can expand on that for you.

    I just spotted another interesting piece about farmed salmon–tanked salmon gets a “best choice” rating from Monterey Bay Aquarium Seafood Watch: http://www.montereybayaquarium.org//cr/SeafoodWatch/web/sfw_factsheet.aspx?fid=133

    And they list the benefits–less food, less disease, etc. Here’s what they say:

    “Salmon farmed on land in “closed” or “contained” farms is a viable alternative that points the way to a more environmentally-friendly future for salmon farming. “

    Neat.

  • Michael Bulger

    The link you provided doesn’t say anything about less feed for inland tank salmon.

    Regardless, this also hinges on whether Aquabounty salmon would be uniquely labeled. Otherwise, consumers might just face a “farmed salmon” label. In that case, the MBA Seafood Watch advice is to “Avoid.”

    That problem doesn’t exist for wild Alaskan salmon, always a “Best Choice.” (http://www.montereybayaquarium.org/cr/SeafoodWatch/web/sfw_factsheet.aspx?fid=27)

  • Mary

    Oh, you have to click the link for the tanked one. It says:

    U.S. farmed freshwater coho salmon currently require much less wild fish in their feed than do other farmed salmon.

    Sure, you can still have wild salmon. But I would rather take the pressure off wild stocks.

  • Michael Bulger

    And as you can see from the MBA report on Alaskan salmon, their populations are robust and they are showing record numbers over the last two decades. According to MBA, the Alaskan salmon is one of the best managed species in the world. Wild stocks are doing quite well because of this approach to fishing.

    All salmon, farmed or otherwise, are pretty inefficient feed convertors. In farms, they require several pounds of fishmeal, soy/wheat, etc. to grow one pound of salmon. When I buy farmed fish, I try to look for vegetarian species that have a better conversion ratio.

    However, as long as salmon are fashionable and can be sold for more money than feed-efficient species, businesses like Aquabounty will look for ways to capture some of the market. In fact, GM salmon are a great example of profit-seeking (as opposed to problem-solving) research.

  • Mary

    All animals are worse than vegetarianism. There’s no FDA requirement for protein conversions rates from any animal and fish farming, it’s unfair to expect that–it’s really not the FDA’s role. I don’t think their assessment has anything to do with profit either. Heaven forfend farmers might make profits from protein conversion. (Some people even buy Kobe beef whose profit-to-conversion data must have escaped the FDA notice?)

    And these are Atlantic salmon. Perhaps I’m more sensitive to the issue of the wild stocks based on the way it looks from New England where the story is much different.

  • Michael Bulger

    I wasn’t suggesting that the FDA had overlooked some feed conversion component that normally appears in reviews. I’m not aware of that being a component (although it certainly impacts the environment). I delved into the feed conversion aspect because you brought it up. It seems the conversation has escaped convention.

    In any case, it hardly seems logical that FDA is tasked with assessing the environmental impact of GM fish. I would think an organization such as NOAA Fisheries would have greater expertise.

  • Foster Boondoggle

    @Michael –

    Comments are a very condensed format and you quickly get the “tl;dr” response from longer attempts. Mary’s interpretation of what I was trying to say is exactly right.

    You can see some experimental evidence here. http://onlinelibrary.wiley.com/doi/10.1111/j.1752-4571.2011.00196.x/abstract . The modified fish are substantially outcompeted in mating by their wild counterparts.

    The article doesn’t focus specifically on the excess growth of the fish, but there are examples all over the domesticated animal and vegetable world — tiny dogs, short stalked/large eared wheat, turkeys with breasts so fat that they can’t naturally mate, etc. The “wild type” for pretty much any organism in its natural environment is going to be close to optimal with respect to attributes that can easily be modified by selection, of which size is a very straightforward one.

  • TR

    Forget salmon altogether. Eat freshwater smelt from the Great Lakes.
    They are an introduced species that has gone super-invasive.
    Do your part and eat em up. Oh yeah, pound for pound, smelt is cheaper and there’s no processing waste since smelt are typically eaten whole. Does eating a whole fish intimidate you? Then, maybe you should go vegetarian.

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