The SciFiles #3: 20 Years Later, Genetically Modified Salmon Approved

I had to write a short, informative, and “unbiased” piece for my work the other month. Posting it here, since it took me a good chunk of the day! 🙂

On November 19th, 2015 the U.S. Food and Drug Administration (FDA) approved the first genetically modified (GM) animal intended for human consumption- AquAdvantage Salmon. The agency reached its decision after 20 years of evaluating research and opinions from a range of sources, including research submitted by the developers themselves (AquaBounty Technologies, a small company in Massachusetts), available peer-reviewed scientific literature, and comments from public hearings and the Veterinary Medicine Advisory Committee. Ultimately, the FDA concluded that the product is safe for humans and animals to eat.

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Both GM and regular Atlantis salmon will end up being the same size, but the GM one will grow FASTER (thus, on the pic, it is larger at the SAME age).

What makes AquAdvantage Salmon unique is that it grows 40% quicker than non-modified farm-raised Atlantic salmon. This effect is achieved by inserting fertilized Atlantic salmon eggs with 1) a growth hormone gene from the Pacific Chinook (or “king”) salmon, and 2) a genetic promoter from an ocean pout fish. This promoter keeps the added gene active all year round, while salmon’s own growth hormone gene is only active in the warmer months. These modifications will not lead to any measurable differences in the GM salmon’s look, taste, or it’s ultimate size and nutrition value, but they will make it grow to adult size quicker.

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Image borrowed from http://www.businessinsider.com/ article by Leslie Baehr

Product Benefits

Clearly, growing almost twice as fast is a considerable economic advantage to fish farmers. In addition, the current practice of catching Wild Atlantic salmon for human consumption is not sustainable as the world’s oceans are already seeing declining fishing yields. Another environmental advantage is a reduced carbon footprint of the fishing industry, as the modified salmon can be grown in captivity close to human populations and reduce transportation costs (in the U.S., 95% of salmon is imported). To the consumer, these factors would potentially result in lower prices and an opportunity to make salmon (a healthy protein choice, according to the U.S. Department of Agriculture) a more affordable part of their diet.

Public Concerns

While the FDA has concluded the GM salmon safe to eat, consumers and public interest groups raise important concerns. One potential issue is the fish escaping into the wild and affecting the environment (e.g. competing with wild salmon for food or mating with it and introducing new hybrid species). The escape scenario, however, is highly unlikely when considering the “multiple and redundant” safety measures in place. First, GM salmon can be raised only in land-based contained tanks in Canada and Panama. Second, there are multiple physical barriers placed in both the tanks and plumbing to prevent the escape of fish and eggs. Lastly, the AquAdvantage salmon is female and sterile, making interbreeding highly unlikely.

In terms of human health implications, Genetically Modified Foods (GMOs) already raise concerns among consumers as people consider possible long-term effects from such a novel technology: 57% of Americans surveyed in 2015 said GMOs were unsafe and 67% stated that scientists do not clearly understand their health effects (Pew Research Center). In contrast, the international non-profit organization AAAS (American Association for the Advancement of Sciences) is more confident about our current state of knowledge, stating that:

“the science is quite clear: […] consuming foods containing ingredients derived from GM crops is no riskier than consuming the same foods containing ingredients from crop plants modified by conventional plant improvement techniques”.

(Full statement: AAAS.org) While GM salmon is now approved for sale (though it will take about two years to reach the market), some retailers have already pledged to avoid the product (e.g. Whole Foods, Trader Joe’s) reflecting such consumer worries.

The Labeling Question
One aspect of the FDA ruling saw particular opposition from public groups: GM salmon will not require labeling. While the FDA issued two recommendations for manufacturers to voluntarily label the product, the agency can only require additional labeling if a material difference is present between a GM and non-GM salmon (e.g. differences in nutritional profile). As no such material distinction has been found, a mandatory labeling might incorrectly imply an essential difference between the two.Screen Shot 2015-12-10 at 8.03.09 PM.png

Another issue with requiring labeling is that a “genetically modified” food is not necessary a meaningful category, and the choice of foods to include in it would be quite arbitrary. After all, humans have been modifying the food supply in various ways for quite some time. This includes “wide cross” hybridization resulting in plants not found in nature (including “heirloom” plant varieties often perceived as more “natural”). Another example is radiation and chemical mutagens that are used on seeds to generate new strains (e.g. a Ruby Red grapefruit, which can carry the “organic” label, was created via mutation due to radiation exposure). In comparison to these methods, genetic engineering is arguably the most precise and predictable technique at the moment.

As a consumer, you have a chance to read and comment on the FDA’s proposed guidelines for the industry’s voluntary labeling of GM salmon until January 25, 2016: FDA Regulations

Online Health Wars: Science vs. Public

Since my research includes asking questions about why people think what they do about health, I spent a lot of time reading various discussion boards and comment sections on different health topics. In the last several days I’ve had such an overload of insane online discussions about vaccines, GMOs, and diets that I almost want to quit… 10559827_1659644964260681_5735123775899498101_nAnd yet the often entertaining arguments keep me coming back! The science folks vs. lay folks debates are also interesting since I am myself an ex anti-science alternative health believer who has now “switched sides” on many issues (or as I prefer/hope to think: turned much more moderate in my views based on understanding scientific evidence better).

Have you ever seen a conversation between a “concerned mom/dad who follow their gut” and a “science proponent with experience in the lab” discussing vaccinations? It is sad and funny as you see things like these:

– science person providing links to peer-reviewed literature (really just abstracts, folks can’t access the full text most of the time), questioning parent’s credentials, attempting to explain herd immunity, claiming they lack understanding of science and suggesting to take an into to epidemiology course, blaming them for increasing rates of preventable disease…and as last resorting to calling them stupid, biased, etc.

concerned parent shares links to blogs and anti-vaccine websites, calls the science person’s degree “useless”, emphasizes their credentials as a parent who “just knows” and does their research (via blogs and specific sites), and very often attacks the science guy/girl as being paid by Monsanto or FDA, being dogmatic and inflexible as their degree was provided by corrupt institutions, being stupid, etc.

10420359_1508161656068484_512410907058098671_nNobody ever appears to switch sides, understand where the other person is coming from, or take their evidence seriously. The process of reading such conversations is often sadly hilarious yet less often informative. But most importantly it shows people’s biases.

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Food Regulation course at O’Neill Institute!

Last week I participated in the Summer Program on Emerging Issues in Food & Drug Law at Screen Shot 2014-07-25 at 11.13.13 AMGeorgetown Law. Other than making D.C. my most favorite US city ever, I met interesting people from various health organizations in US, EU, India, China, and South America!

While a lot of the information went way over my head (considering I have no background in law or drugs!), there are a couple of interesting things I learned:

  • US imports a lot of food! About 80% of seafood and about 50% of fruits and 20% of vegetables is also imported.

This means that food safety monitoring requires a global regulatory environment and FDA (food&drug administration) has posts worldwide (China, India, Mexico, Costa Rica, London, Brussels, Africa). Most people I interview are concerned with food’s effect on their long-term well-being mainly because they don’t see food safety in terms of immediate harm as a big issue. That is the privilege of living in a well-regulated country like the US.

Our speakers gave an example of locally produced cheetos-like snacks somewhere in Africa that, aside from the fact that’s not a healthy thing to consume in general, were found to contain actual orange paint, rat droppings, and some heavy metal contamination. Another example of poor food safety regulation that we don’t have to worry about here is a story from my mom: around the time Ukraine became independent she bought a chocolate bar with raisins. After being unable to chew on the raisin for awhile, she washed it to discover it was a raison-shaped PIECE OF PLASTIC. Now THAT is scary. 😦

  • Differences in the way US and EU (European Union) regulates foods.

The most crude way to describe the difference is that EU takes a precautionary approach (e.g. GMOs might have bad effects years later so we’d rather limit them) while US takes a free market approach (there’s no evidence GMOs have adverse health effects, so why limit them?). I have to say most of us in the auditorium sided with the EU mentality as waiting for evidence that something is bad is more reassuring than proceeding due to lack of evidence. We know science takes time and the issue with GMOs is that their safety studies would have to take decades.

  • FDA regulations!asdf

The FDA does a lot of great work yet it can be quite hard to understand this agency’s ways. Mainly I was interested in how they regulate food health claims on products. I found out that if a product
makes a general structure/function claim (e.g. nuts are good for your heart! carrots maintain good eyesight!) the FDA doesn’t care much as they have less authority over such statements. If you, however, make a HEALTH CLAIM (e.g. nuts prevent/cure heart disease!), the FDA has authority to conduct a pre-market review of such health claim.  They need to see that the proposed food’s health claim is TRUE according to a narrow set of guidelines/that the product successfully performs the promised benefit: e.g. that consuming nuts actually affects a certain established biomarker of heart disease (e.g. one established biomarker would be LDL cholesterol). If your product has a health claim the FDA has not reviewed they would send you warming letters and can shut you down.

I understand this part can bother a lot of people who are trying to eat healthily. E.g. several years ago FDA222222 sent warning letters to a walnut company warning them about claiming walnuts prevent heart disease (i believe?). A lot of people in the health community were outraged. But think about a different example- Kellogg mini wheats. They claimed that kids will perform 20% better in school when eating them for breakfast. They then claimed the cereal increases immunity. Then Activia claimed their yoghurt benefits digestion. All lost in lawsuits as their own studies did not support such claims. So, while many of us are biased toward natural foods and were mad about the walnut case, you see where such regulations come handy and are necessary across the board. Also, the claims have to be supported by recognized science, which means that if some studies show your product is amazing for condition X, while others studies show no effect you have to report about both in your claim.

  • Something i was particularly interested in was comparing food quality standards (vs. food safety that FDA is mostly concerned with) in Ukraine and the US.

The Ukrainians I interviewed last summer had very low trust in the quality of food produced in Ukraine. one of the main reasons was the fact that after the fall of USSR, the Government Food Quality Standards became weak and prone to manipulation by the industry. During USSR, there were set food standards called “Recipes” that spelled out what makes up a certain product. E.g. a sausage ought to have a certain percentage of high quality meat.

"Belorussian Goods: High USSR quality". Ukrainians love belorussian foods as the country maintain the high standards for foods created during the Soviet era
“Belorussian Goods: High USSR quality”. Ukrainians love belorussian foods as the country maintains the high standards for foods created during the Soviet era (unlike Ukraine)

Nowadays manufacturers can create their own “recipes” and thus make “sausage” that is 80% soy. I asked the food standards question and learned that US has “standards of identity”  which is also a “recipe”. These standards of identity are mandatory, federally set requirements that determine what a product must contain to be marketed under a certain name in interstate commerce. So an ice-cream is supposed to have real milk, for example, and some other ingredients. Just like in Ukraine, though, manufacturers can bypass these standards by simply labeling their product something else (e.g. “Gelato” you might see on the shelf is not called ice-cream for a reason- it does not have the correct ingredients to be called an ice-cream). Violating standards of identity can be either good or bad for us. Good:  perhaps new recipes of old products can contain healthier products (e.g. almond milk in an ice-cream type of dessert), but the dark side here is that manufacturers can pack products with cheaper unhealthier ingredients. In Ukraine, the second situation is the case: many foods have low quality (e.g. a lot of people distrust Ukrainian butter as majority of it is actually palm oil). More here  http://uspolitics.about.com/od/usgovernment/a/fda_identity.htm

Unrelated to the topic of food.. i learned that counterfeit drugs is a scary issue! Prescription drugs are quite easy to “fake” and most of them look identical to the original product (to the na111ked eye, that is).  The danger of counterfeit drugs is the fact that, while 20 years ago most of them were just placebos, now they contain some amounts of active ingredients that can make a person feel somewhat “better”. The problem is that such various doses of active ingredients are not tested and can cause serious health issues. US has very strong regulation and monitoring of drugs so you are extremely unlikely to just buy some at a local store. You can get exposed to them, however, if you use online pharmacies. Many “fake” pharmacies based in China look legitimate and claim to be based in US or Canada.

For info on safe internet pharmacies: http://www.safemedsonline.org/who-we-are/principles-participation/

BOTTOM LINE: Food policy and regulation is a very complicated issue!!! Obviously a lot is done to keep our food safe, but the food QUALITY subject is very unclear due to different perceptions of “healthy” foods, the complex nature of nutrition science and the huge amount of conflicts of interest.