Author: Lisa Hurst

A Massachusetts-based company [in March 2019] cleared the last regulatory hurdle from the Food and Drug Administration to sell genetically engineered salmon in the U.S. Animal genomics expert Alison Van Eenennaam, who served on an advisory committee to the FDA to evaluate the AquAdvantage salmon, explains the significance of the FDA’s move and why some have criticized its decision.

How is AquaBounty’s salmon different from a conventional salmon?

The main difference is that AquaBounty’s AquAdvantage salmon grows faster than conventional salmon, and therefore gets to market weight in less time. This is desirable for fish farmers because it means the fish require less feed, which is one of the main costs in aquaculture.

Fast growth is a commonly selected characteristic in food animal breeding programs. The growth rate of chickens, for example, has increased dramatically over the past 50 years thanks to conventional breeding based on the naturally occurring variation in growth rate that exists between individual chickens.

image source: Scientific American

To produce the AquAdvantage salmon, Canadian researchers introduced DNA from the King salmon, Oncorhynchus tshawytscha, a fast-growing Pacific species, into an Atlantic salmon genome 30 years ago. The AquAdvantage salmon are several generations removed from that original fast-growing founder fish. These fish inherited the King salmon fast-growth gene from their parents in the normal way, passed down through sexual reproduction.

The Food and Drug Administration approved AquAdvantage salmon in 2015. Why couldn’t it be sold in the United States until now?

Because the AquAdvantage salmon is a genetically engineered animal, it was required to undergo a mandatory premarket FDA safety evaluation. The agency completed that evaluation and determined the fish was safe in November 2015, after almost two decades of regulatory scrutiny.

Following this approval, Alaskan Sen. Lisa Murkowski introduced language into the 2016 federal budget bill that banned importation and sale of the genetically engineered salmon until such time as the FDA “publishes final labeling guidelines for informing consumers of such content.” According to her press release, she did this to protect Alaska’s fishing interests and Pacific “salmon stocks from the many threats of ‘Frankenfish.’

Soon afterward, the U.S. Department of Agriculture was tasked with developing the “National Bioengineered Food Disclosure Standard,” also known as the GMO labeling rule, which became effective on Feb. 19, 2019. This rule requires the fish to be labeled as bioengineered food.

In response, the FDA deactivated the 2016 import alert that prevented the genetically engineered salmon from entering the United States, clearing the way for its sale here. The fish had already been approved in Canada in 2016 and has been sold there since 2017.

Is there evidence that eating genetically engineered salmon could be harmful to people’s health?

No. The FDA evaluated the fast-growing salmon and concluded that it was as safe as conventional salmon. The agency determines safety by compositional analysis – basically, grinding up genetically engineered salmon and control fish samples and comparing them. In these analyses, the genetically engineered salmon and wild Atlantic salmon were not found to differ.

It was also determined that the introduced King salmon gene was not a novel allergen. Needless to say if you are allergic to fish, don’t eat this AquAdvantage salmon or any other salmon either. In reality, there’s no such thing as a completely “safe food,” so what the FDA scientists concluded was that the food from AquAdvantage salmon “is as safe as food from non-GE Atlantic salmon.”

Some critics argue that the genetically modified salmon will escape and mix with wild stocks of fish. How likely is that?

AquaBounty is using multiple, redundant biological, geographical and physical containment measures that collectively decrease the possibility of its salmon escape and interbreeding with wild stocks of fish.

Currently, it is growing its engineered fish in land-based freshwater tanks in an FDA-inspected facility in the highlands of Panama. This limits their interaction with wild stocks of fish. They are also being raised to be all-female and triploid. Triploidy means the fish have three complete sets of chromosomes rather than the usual two. Triploidy renders females essentially infertile.

The fertile broodstock fish as maintained in a closed FDA-approved facility on Prince Edward Island in Canada that has physical and geographical containment measures. After reviewing those safeguards, Canadian health and environmental authorities concluded that “The likelihood of (genetically engineered salmon) exposure to the Canadian environment is concluded to be negligible with reasonable certainty.”

In 2017 AquaBounty purchased a fish farm in Indiana where they plan to grow out genetically engineered salmon. This site was approved by the FDA in 2018 as a grow-out facility. The advantage of growing the salmon in land-based facilities in the United States is that it provides a local source of domestically produced Atlantic salmon. Currently, most salmon eaten in the United States is farmed Atlantic salmon imported from Chile, Norway, and Canada incurring considerable transportation costs and carbon emissions.

Source: Indianapublicmedia.org

The Pacific coast has a wild salmon fishery, and some of its representatives say the genetically engineered salmon is an ecological and genetic threat to native gene pools. But Atlantic salmon (Salmo salar) are in a different genus from Pacific salmon (Oncorhynchus spp.) species. This means they cannot interbreed.

In my view, claims that AquAdvantage salmon will negatively affect wild Pacific salmon populations are unfounded, due not only to the fact that AquAdvantage salmon are being raised in land-based tanks with multiple redundant physical, geographical and biological containment measures to prevent fish from escaping, but also due to the basic genetic incompatibility of these two distinct genera of salmon.

Where can I read more?

There are two comprehensive yet comprehensible write-ups that I highly recommend for readers looking for more detailed information on the science and politics of the AquAdvantage salmon. The first is from factcheck.org, a project of The Annenberg Public Policy Center, entitled “False Claims about ‘Frankenfish,’” and the second is by the independent educational site biofortified.org, entitled “Fast-growing genetically engineered salmon approved.”

Does glyphosate—the world’s most heavily-used herbicide—pose serious harm to humans? Is it carcinogenic? Those issues are of both legal and scientific debate.

In two court cases—one decided in mid-March and the other last year— juries have ruled that glyphosate, sold in non-generic form under the trade name Roundup and made by Monsanto (now a division of Bayer), caused the cancer of workers who applied the herbicide. Neither case addressed the issue of whether glyphosate might cause harm to humans exposed to parts per billion or parts per trillion traces of the pesticide found in foods.

Courts do not determine scientific fact

Of course, a jury decision, while significant, is not a substitute for scientific research. Juries have also gotten science wrong, most infamously the decision in the ‘Scopes Monkey Trial’ in which high school teacher John Scopes was found guilty of teaching evolution, which creationists contended was not scientifically supported.

Cases like these that revolve around the question of whether a particular chemical is the cause of cancer or another illness are not science. They rely on lay juries attempting to make sense of complicated and often contradictory medical studies and expert opinions. Science rarely renders absolute ‘verdicts’; it addresses probabilities. It’s been shown time and again that when juries are asked to evaluate studies that conclude ‘substance x is unlikely to cause cancer’, they almost always assume the worst, that because the study did not definitively conclude it ‘does not’ or ‘could not cause cancer’.

But no scientists writing a reputable study would ever use the kind of absolute statements that would put a jury at ease. Hence, when jurors have even slight doubts, they frequently rule against a chemical and its manufacturer, and for an aggrieved (and often fatally ill) plaintiff, even when the evidence is slim or close to nonexistent.

For example, just last year, a Missouri jury awarded $4.69 billion to women with ovarian cancer they claimed was caused by Johnson & Johnson baby powder. In April 2018, the company was ordered to pay $117 million to a New Jersey man with mesothelioma, and $25.7 million to a Los Angeles woman with the same cancer.

As Popular Science has reported, the company is appealing those verdicts, and for good reason: They don’t appear to comport with the science.

Medical studies on the relationship between ovarian cancer and talcum powder use on the genitals are not at all definitive, with none showing a strong association and most showing no association at all. The National Cancer Institute says the evidence is not strong enough to conclude that talcum powder causes ovarian cancer, and the American Cancer Society notes that any existing risk is likely small, and that research is ongoing.

What the legal system considers enough evidence to establish that exposures causes illness is different from the standards of science—and trying to fit the two together can be hazardous. Which brings us back to the controversy over glyphosate.

What do regulators and investigatory agencies conclude?

Even though extensive research has been done on glyphosate, there remains intense debate online and in the media about whether the herbicide poses a health threat to agricultural workers or the general public as a result of residues in food.

More than a dozen regulatory and research agencies have conducted long-term studies, reviews and assessments to determine whether glyphosate when used as labeled, increases the risk of certain cancers. They are unanimous in one finding: There is no evidence that glyphosate poses any harm to consumers worried about trace residues in their food. Despite many blogs by anti-biotechnology advocacy groups touting ‘studies’ (usually not very scientific, such as here, most recently) finding glyphosate in beer or cereal at the parts per billion or parts per trillion level, or finding traces of glyphosate in blood or urine, there is no scientific study that suggests those trace residues pose any threat to humans.

The Genetic Literacy Project summarized and analyzed the findings of the world’s top regulatory and research organizations in a GMO FAQ posted here on our GMO FAQ section. To date, every regulatory agency that has evaluated glyphosate has concluded that it is safe if used according to label specifications and does not increase cancer risk, particularly if glyphosate residue is found on food, including produce.

This infographic summarizes the conclusions of the most prominent agencies. The global consensus is concisely expressed by Health Canada, the oversight agency that most recently issued a re-review of the controversial pesticide: “No pesticide regulatory authority in the world currently considers glyphosate to be a cancer risk to humans at the levels at which humans are currently exposed,” Health Canada wrote in January 2019.

In addition to the many assessments and evaluations, a large and long-term study known as the Agricultural Health Study has monitored the incidence rate of multiple cancers in 54,251 pesticide applicators, including 44,932 who had handled glyphosate since 1993. The study found no association between glyphosate and any solid tumors or lymphoid malignancies overall. The data is ambiguous in workers exposed at very high levels.

The only outlier is the International Agency for Research on Cancer (IARC), which does not look at the risk posed by a particular chemical. Rather, it examines hazard—whether a substance might cause cancer at any exposure rate or dose, even unrealistically high ones. In 2015, IARC put it in the category “probably carcinogenic to humans,” along with red meat and hot beverages. But there was less evidence of carcinogenicity than the agency found for bacon, salted fish, oral contraceptives and wine, among many examples.

Over more than 40 years, the agency has assessed approximately 1,000 substances and activities, ranging from arsenic and beer and coffee to sunbathing and hairdressing. It has found only one agent or activity that was “probably not” likely to cause cancer in humans. Under a hazard designation, almost any substance can be judged toxic, even water, if the dose is extreme and the exposure time is long enough. The hazard-risk distinction is almost totally absent from the popular and media discussion of whether glyphosate might pose any serious danger.

IARC is a sub-agency within the World Health Organization of the United Nations. Its ‘hazard’ conclusion that glyphosate should be in the category “probably carcinogenic” has been used to support proposed bans on glyphosate and was the central piece of evidence in the two recent trials. Three other WHO agencies including WHO itself performed risk assessments on glyphosate and repudiated IARC’s findings, but their far more comprehensive analyses are usually ignored in media accounts or not even considered by juries.

Click on the image below to see a summary of all the most respected research. The bolded conclusions will take you to the document issued by the regulatory or research agency.