The Pros and Cons of Genetically Altered Salmon

MS. DIANE REHM

10:06:54
Thanks for joining us. I'm Diane Rehm. The FDA held hearings this week on genetically engineered salmon. If approved, it would be the first time the FDA allowed an animal with modified genes to be raised as food for American consumption. The agency is trying to determine if the fish is safe for people and the environment, and if it okays the fish, whether consumers have a right to know what they're buying. Joining me in the studio to talk about the science and politics of genetically modified salmon, Val Giddings of PrometheusAB and Andrew Pollack of The New York Times. Joining us from a studio in New York, Michael Hansen of Consumers Union. I'm sure many of you have your own questions, comments about this issue, so feel free to join us, 800-433-8850. Send us your e-mail to drshow@wamu.org. You can join us on Facebook, or send us a tweet. Andrew Pollack, if I could start with you, the FDA just held two days of hearings on genetically engineered salmon, which I know you attended. What was the focus of the hearings?

MR. ANDREW POLLACK

10:08:42
Well, on Monday, the focus was, are the fish safe for consumption and for the environment? And the focus on Tuesday was, if the salmon are approved, should they be labeled as genetically engineered or in any other way?

REHM

10:09:03
Give us a sense of the arguments on both sides that you heard.

POLLACK

10:09:10
Of the labeling, or of the safety?

REHM

10:09:12
Both.

POLLACK

10:09:14
Well, on the labeling, various consumers groups argued that American consumers have the right to know what they're eating and that genetic engineering is a different kind of food, and therefore the food should be labeled as such. The FDA and certain representatives, both of the fish developer and of the food industry, argued that the current FDA policy is correct, which is that food should be labeled only if there is something materially different about the food from a similar food. So in other words, if the salmon tasted different, had different nutritional characteristics or somehow was less safe -- such as more allergenic -- that should be labeled, but not the mere fact that it was created by genetic engineering.

REHM

10:10:15
Andrew Pollack, he is biotechnology reporter for The New York Times. Val Giddings, I wonder if you could explain for us just how the fish is genetically altered.

MR. VAL GIDDINGS

10:10:29
Well, the difference between this salmon and wild salmon is that for this salmon, they took a gene from Chinook, from Atlantic salmon, that encodes for the Atlantic salmon's growth hormone gene. And they attached to this gene an on switch derived from another ocean fish.

REHM

10:10:47
What's an on switch?

GIDDINGS

10:10:49
Well, the genetic term that we use is a regulatory sequence. It regulates the expression of the gene that encodes for the growth hormone.

REHM

10:10:56
I still don't get it.

GIDDINGS

10:10:58
It's an on-off switch. When the switch is on, the growth hormone is manufactured, and then it circulates in the body to have that physiological impact of encouraging growth. When it's off, you have no production of the growth hormone gene, and therefore the body is not stimulated to grow. In wild salmon, their growth hormone -- excuse me -- is turned on in the spring and summer when food is abundant. It's turned off in the autumn and winter when food is scarce. What AquaBounty did is they took a switch -- an on switch -- that keeps the expression of the growth hormone gene constant year-round. Therefore, the fish grows year-round. It eats year-round, and that's the key to its phenotype of reaching market size in about -- excuse me -- a year to 18 months, rather than the usual three years.

REHM

10:11:46
Help me to understand, Val, your own connection with AquaBounty.

GIDDINGS

10:11:54
I started out as a skeptic about this fish. I'm very concerned about wild salmon. And when I first heard about this 15 years ago, I thought, we don't need any more risks for wild salmon. I don't like this idea. The founding CEO of the company heard me say this at a public meeting, came up, engaged me in a conversation. We've had many conversations since then, become a close friend. He asked me to speak to some media this week, and that's what I'm doing. I now work as an independent consultant. They're not paying me to do this. I'm a biotechnology specialist. I've been working in this arena for 25 years, and I'm very familiar with the case.

REHM

10:12:31
I'm interested that AquaBounty is not sending its own representative to speak for this issue.

GIDDINGS

10:12:40
Well, they've been -- my understanding is they've been pretty focused on making sure that the questions the FDA has, has been answered. And they've had limited time to talk to media.

REHM

10:12:51
Val Giddings, he's president of PrometheusAB and a former consultant to AquaBounty. Andy, coming back to you for a moment, what did the FDA say about these studies that were submitted to support approval of the fish?

POLLACK

10:13:14
Well, the FDA -- the bottom-line conclusion of the FDA itself after looking at the studies, was that this fish is the same as any other farmed Atlantic salmon in terms of its safety and that it would pose very little risk to the environment, mainly because various precautions are being taken to make sure that the fish do not get out of the fish farm. And they're also rendered sterile so they could not interbreed if, by chance, they were to escape. The advisory committee spent Monday reviewing these studies, and they point it to a fair amount, I thought, of holes in the studies or things that were not quite complete, things that could have been done better, larger sample sizes could have been used.

POLLACK

10:14:07
And the FDA, for its part, even criticized some of the studies that AquaBounty had done. But the FDA concluded that despite some less than ideal data, the fish were safe. And the advisory committee -- also, no one came out and said this fish is a hazard and should not be marketed. Some said, well, you know, the data leaves something to be desired, and we should perhaps do some more study. And some thought the fish was -- would be fine.

REHM

10:14:41
And what did the FDA say about the labeling question?

POLLACK

10:14:48
Well, the FDA says that under the law, as I explained before, there can be no labeling of a product that's genetically engineered. The only kind of label would be something that's materially different about the food itself, not the production process. For instance, they can't force someone to label whether, you know, meat came from a cow raised on an industrial feedlot as opposed to grazing in the field. So...

REHM

10:15:20
But that wouldn't be a genetically altered cow?

POLLACK

10:15:24
No. But they consider genetic engineering a production method, and they say that the courts have backed up that such labeling cannot be done for genetic engineering. It's not done now for products made from genetically engineered crops. And if there is something different about the salmon such as, you know, it's lacking a vitamin per se, then that might be on the label.

REHM

10:15:50
All right. Turning to you, Michael Hansen, at Consumers Union, I gather you have some concerns, not only about approving this product, but also the question -- the issue of labeling.

MR. MICHAEL HANSEN

10:16:09
Yes, that's correct. On the safety issue, I would like to point out that the question that the advisory committee was asked is, is there -- and this is the legal standard -- is -- does the data show reasonable certainty of no harm from consumption of food derived from AquAdvantage salmon? And nobody answered that question, yes. They were overwhelmingly skeptical, in part because of the bad data. As an example, the FDA identifies as one of the direct effects, risks that should be looked at, is they say the alteration from the gene expression product. That is, they identified the Chinook salmon growth hormone as a potential problem that needs to be investigated.

MR. MICHAEL HANSEN

10:16:56
The company submitted data on the levels of the growth hormone in the flesh of these fish. They tested 73 fish, and the method they used to test was so insensitive that they could not detect it in a single fish. So that means zero data on the growth hormone levels. And the FDA concludes from that, that there is no biologically relevant differences in growth hormone levels between the fish. That's just not good science. That would -- if you were an undergraduate, and you tried to put that into a paper, you would get a failing grade. When you do not have data, you cannot make any conclusion about whether there are differences or not because you have no data. The other direct effect that they mentioned also was another hormone called insulin-like growth factor number one, which has been linked to cancers.

MR. MICHAEL HANSEN

10:17:51
Again, when they looked at that in the vast majority of fish, they could not detect it. They then conclude that there's no difference. Again, if you don’t have data, you can't conclude there's a difference. Then, they looked at one indirect effect that they decided was a hazard, is that since fin fish, such as salmon, are one of the eight major allergen groups, one of the eight major allergenic foods, so there's -- the question is, could an indirect effect of the genetic engineering be to increase that allergenicity, the background to allergenicity?

REHM

10:18:27
All right, and we'll stop there. Michael Hansen is senior staff scientist for Consumers Union. Short break, and then your calls.

REHM

10:20:04
And we are talking about genetically modified salmon coming to the market. The FDA held hearings on this, this week. Here in the studio, two guests. Val Giddings, he is president of an organization called PrometheusAB. I don't know what that means.

GIDDINGS

10:20:26
It's my consulting firm.

REHM

10:20:27
Your consulting firm. And he is a former consultant to AquaBounty, the corporation that wants to bring genetically altered salmon to the marketplace. Andrew Pollack is biotechnology reporter for The New York Times, and from a studio in New York, Michael Hansen. He's senior staff scientist for Consumers Union, and, of course, Consumers Union publishes Consumer Reports. We're going to open the phones shortly. You can join us at 800-433-8850. Send us your e-mail to drshow@wamu.org. Michael, just before the break, you were talking about the allergenicity of these genetically altered salmon. What's your concern?

HANSEN

10:21:31
Well, the company themselves provided data. And what they did is they took blood from people that have allergic reactions to salmon. And then what you do is you can look at how that blood reacts to a regular salmon and reacts to genetically engineered salmon to see if there's a greater reaction so you can look at allergenic potential. And there's three types of fish they looked at. The normal fish. Then they genetically engineered it, but the fish they want to sell are not only genetically engineered, but they make them into sterile females. The sample sizes they used were very small, just six fish. But yet when they looked at the regular fish compared to the genetically engineered fish, there was extremely highly statistically significant increase in the allergenic potential. The lowest for the engineered fish -- the lowest level of allergenicity for the engineered fish was higher than the highest level for the controls. That's an extremely significant difference.

REHM

10:22:31
All right. Let...

HANSEN

10:22:32
But what they said is, those fish aren't being sold. If you look at the sterile females, they were 20 percent higher. That difference wasn't statistically significant, but it's a small sample size.

REHM

10:22:43
Okay.

HANSEN

10:22:43
The fact of the matter is this demonstrates that genetic engineering has increased the potential allergenicity of this fish. That means you need more data. And I should also point out, all the fish they tested were once raised up in Canada. That's not what they want approval for. They want approval for fish raised in Panama. And so you need data under the conditions that the fish are going to actually be produced under, and...

REHM

10:23:08
All right. Michael, I'm going to stop you right there because what I want to ask you is whether your conclusion is that you want to keep these genetically altered fish off the market completely, or whether you want to see them labeled as such.

HANSEN

10:23:30
Before they come on the market, we think that the safety test should be redone under scientifically valid concerns. If they can meet those concerns, then they should come out -- then they could come out in the market, and if they do, they should absolutely be labeled. And I should point out, as I did yesterday, that the FDA's analysis of this materiality that it has to be a physical difference, is just false. And they have misinterpreted what the court said.

REHM

10:23:59
All right. Michael, I want to give Val Giddings a chance to respond both to your argument that the safety tests have not been sufficiently done, and, second, that if these salmon are allowed to come on the market, they should be labeled as such. Val.

GIDDINGS

10:24:21
Thank you, Diane. Michael has made a number of misfactual misstatements. The only way your listeners are really going to be able to get to the bottom of this is if they go and look at the FDA's briefing packet that they posted on the Web. If they Google it and enter the key search words -- FDA, briefing packet, salmon -- they'll find there are posted about 300 pages of risk analysis information that the FDA relied upon. These data, some of the studies are imperfect. They are not, in fact, ideal, and some of the samples should be larger.

GIDDINGS

10:24:54
But the bottom line fact that Mr. Hansen is obscuring is that no other salmon in the history of the planet has been subjected to even remotely as much scrutiny as have these. The FDA concluded, from all of this unprecedented scrutiny, that they looked for -- and I quote -- "We looked for direct food consumption hazards. None were found." On the issue of allergenicity, I take that one particularly -- personally because my son has a life-threatening food allergy. Most folks don't have food allergies and find it difficult to appreciate the nature of the concern that those of us from that community do have. Mr. Hansen has grossly misstated and completely falsely mischaracterized the data and the conclusions derivable from them. The FDA stated the expression of Chinook salmon growth hormone in ABT salmon does not present a new risk of allergic reaction to salmon-allergic individuals and is unlikely to cause allergic cross-reactions.

REHM

10:25:51
Let me...

GIDDINGS

10:25:51
Mr. Hansen is crying wolf, and it's inappropriate.

REHM

10:25:54
Let me ask you about his point that the fish you tested -- that the FDA tested --were actually from Panama versus Canada.

GIDDINGS

10:26:07
No. He's claiming they should be from Panama rather than Canada. But this is an -- the fish that were tested were raised in Canada. They've not been raised in Panama yet because that facility has not yet been approved by FDA for the use in producing these fish. But this is an irrelevant objection anyway because the system in which these fish will be produced is a closed-circuit contained system inside a concrete building. So it doesn't matter whether you put it in Panama, in Prince Edward Island or above the Arctic Circle.

REHM

10:26:35
Does it matter...

GIDDINGS

10:26:36
No, it doesn't.

REHM

10:26:36
...Michael? Excuse me, Val.

GIDDINGS

10:26:38
Sorry.

REHM

10:26:38
Does it matter, Michael?

HANSEN

10:26:41
Yes, it does. And in fact, I would also encourage people to look at the briefing packet as well because the FDA, in the briefing packet, they had -- they say explicitly that salmon raised in Panama will be different. It's different rearing conditions. But they say the effect that that will have on the AquAdvantage phenotype, which means its characteristics, is unknown. All right? So to say that there won't be any differences, that's not what the FDA is saying. They say it's unknown, and they have no data.

HANSEN

10:27:14
As for the hormone, which they identified as a direct risk and then they said there's no problem, I would encourage people to go to Table 15 in that briefing packet. And you will see, for the growth hormone, they have no data, zero data. And they conclude that that's not a -- that there's no differences between the fish in growth hormone. Val, what scientist would conclude in the space of no data on the growth hormone? That's what they identify as a risk. They have no data on it, and yet they're concluding that there's no differences. That is not good science. You can look at the briefing packet.

REHM

10:27:51
All right, Michael, let's let Val respond.

GIDDINGS

10:27:56
There are about 30 data tables in this briefing packet.

REHM

10:27:58
How can listeners be clear on this when we've got two men with absolutely opposing perspectives? One says, there's no data, the other says, there's at least 30 data. Andrew Pollack.

POLLACK

10:28:19
Well, welcome to the world of biotechnology. This is one of the most polarized issues, and people will differ over even, you know, very obscure points.

REHM

10:28:31
But then how can the public be reassured or even assured?

POLLACK

10:28:39
Well, it's impossible to prove absolute safety and rule out any possibility of some harm with absolute certainty. This FDA process is meant to try to do that. You know, the FDA reviewed these studies. And though they did note some anomalies, they said, well, these things seem minor, and they don't take away from our overall conclusion that this would be safe. Now, some people, like Michael Hansen, would differ with that conclusion. And that's part of the scientific process. Then they had the advisory committee meet all day Monday to look at the data and to look at FDA's analysis of the data and say whether they agreed with the FDA or not. And they were a little more skeptical than the FDA itself.

REHM

10:29:32
Val Giddings, what is the advantage to the consumer of this genetically altered salmon?

GIDDINGS

10:29:43
There are several advantages. They come under the issue of both health and environment.

REHM

10:29:47
Health?

GIDDINGS

10:29:47
Health.

REHM

10:29:48
How?

GIDDINGS

10:29:49
This is a nutritious food. Nutritionists tell us we should be eating more salmon.

REHM

10:29:53
Sure, but how different from ordinary salmon?

GIDDINGS

10:29:57
It's...

REHM

10:29:57
What's the advantage?

GIDDINGS

10:29:59
It's indistinguishable in terms of its material composition.

REHM

10:30:02
I'm asking what the advantage is.

GIDDINGS

10:30:04
The advantage is this will enable more salmon to be produced at lower cost in closer proximity to the consumption sites to where people will eat it. And therefore, it will have an environmental benefit as well of a lower carbon footprint. You're not having to fly the salmon in from Chile or Norway.

REHM

10:30:19
All right. Michael, how do you respond?

HANSEN

10:30:22
Again, one of the main reasons why people would want to eat salmon, the health benefit is for these omega-3s. And what you want is you want as much omega-3 fatty acid as possible. And you want the ratio of what's called the omega-3 to omega-6 fatty acids to be as high as possible. When you compare this engineered fish to wild fish, they're clearly inferior from -- again, from the briefing packet, page 95, table 28 -- if you look at wild-caught salmon, that omega-3 to omega-6 ratio is 10.4. If we look at the AquaBounty salmon, it's 3.6.

REHM

10:31:02
All right. Val Giddings.

HANSEN

There's three times higher omega-3.

REHM

10:31:04
Okay. Val Giddings, do you want to respond?

HANSEN

10:31:07
Table 28.

REHM

10:31:08
Excuse me. Go ahead, Val.

GIDDINGS

10:31:09
And the ratio from farm-raised salmon is 3.9, which is biologically -- which is statistically indistinguishable from 3.6. It's true that wild fish have higher omega-3 levels, but the omega-3 levels...

REHM

10:31:22
Yeah...

GIDDINGS

10:31:22
...in this fish are the same as in other farmed fish.

REHM

10:31:26
What about that, Michael? Everybody is eating farmed salmon these days.

HANSEN

10:31:32
Well, what Val says is true. But I think the average person -- when they buy salmon, they think farmed salmon is just as good for them in terms of the omega-3s as wild salmon.

REHM

10:31:42
Okay.

HANSEN

10:31:42
Maybe if people knew that they weren't -- these are inferior...

REHM

10:31:45
Yeah...

HANSEN

10:31:45
...from a health viewpoint. Wild salmon are superior to farmed salmon. And actually, the AquaBounty are a little bit worse from...

REHM

10:31:52
All right. All right. Now, what about the labeling issue, Michael?

HANSEN

10:31:59
Yes. For the labeling, this notion that there has to be a physical difference is just false. The FDA -- for example, in 1991, hydrolyzed protein is put into lots of canned foods. The FDA required explicitly that the source of that protein has to be labeled because, for example, if you're a vegetarian, you would want to know whether this hydrolyzed protein comes from an animal. If you're a kosher Jew or a halal Muslim, you want to know whether it comes from a pig, and that's exactly what the FDA said. Here's what they said in 1991, in the Federal Register, talking about this source labeling for hydrolyzed proteins. Quote, "The food source of a protein hydrolysate is information of material importance for a person who desires to avoid certain foods for religious or cultural reasons."

REHM

10:32:55
All right. Val...

HANSEN

10:32:56
So you can label for this -- wait a minute.

REHM

10:32:57
Sure.

HANSEN

10:32:58
There is the Karuk Tribe in Northern California and Oregon.

REHM

10:33:01
Okay. Michael...

HANSEN

10:33:03
They...

REHM

10:33:04
...I don't want to get into very, very minute issues. What I do want to understand from each of you is why you think labeling is or is not important. Val Giddings.

GIDDINGS

10:33:22
Some kinds of labels are appropriate, some are not. The FDA does not require labels to meet kosher or halal standards. The FDA requires labels to be accurate, informative and not misleading. I think that any label that is put on this salmon -- and I expect that it probably will carry a label in the end. The company has said that they are not objected -- they have no objection to such labels, and they plan to label what they sell which is the eyed fish eggs. But any label that is put on the ultimate consumer product must be accurate, informative and not misleading. We know that, fully, a third of the fish in the market today are mislabeled. Cod is -- haddock is being sold as cod and so forth.

GIDDINGS

10:33:59
But it is important to make sure that consumers have accurate information. And there are activist groups out there who intend to use a mandated biotech label or GE label in order to mislead consumers that -- and suggest that they are not safe when the data show otherwise.

REHM

10:34:17
What would happen, Michael, from your perspective, if these bioengineered salmon were released into the wild?

HANSEN

10:34:30
Well, if they actually got out into the wild -- if they got into habitats where salmon are -- since these grow much faster, and they are more aggressive feeders, they could out-compete not only wild salmon, but it turns out the behavior of these fishes -- they hunt in different environments than regular salmon. So they could have an impact on different species. There are a number of papers by scientists who have studied these various engineered salmon. They are concerned over this. So the concern is whether they get out or not.

HANSEN

10:35:08
This whole notion that they're fine because there's one facility down in Panama -- what the concern was is, well, what if they decide to sell these eggs to China or to Chile? Who's going to have control over that? And what the FDA said, those are sovereign countries. They can make their own decisions. So if this -- if they decided to go to China, and they wanted to grow them in net pens, there would be nothing stopping them. Those fish, if they're not labeled, they would come back into the U.S. And we would have no idea because they wouldn't be labeled.

REHM

10:35:40
All right.

HANSEN

10:35:40
So by giving them approval...

REHM

10:35:41
Okay. Let me stop you right there. Andrew Pollack, if the FDA approves this salmon, what kind of precedent might it set for other species?

POLLACK

10:35:57
Well, there have been other attempts to genetically engineer farm animals. Many of them have fallen by the wayside over the years because A, the -- it was not clear whether they really could get approval, and B, it's quite expensive to develop such an animal, feed them for years in order to test them. And there's, of course, concern whether consumers and also companies in the food chain would accept these things, so -- but there are some that could get approved. There is something called the Enviropig which was developed at a Canadian university, which has manure that is less polluting than the regular pig. So that would be next in line. People have worked on cows that are resistant to mad cow disease or that might have healthier meat and pigs that have healthier meat. And there are lots of projects around the world to make fast-growing other types of fish.

REHM

10:36:58
So considering that fact, considering the precedent it could set, shouldn't the FDA -- or wouldn't the FDA take a special care in this regard?

POLLACK

10:37:15
Yes. And I -- you know, I'm not going to speak for the FDA, but, you know, I believe that they would argue that they are taking special care of this. Fish has been in the regulatory process for over 10 years, and they're having these hearings now, so...

REHM

10:37:31
Andrew Pollack, biotechnology reporter for The New York Times. When we come back, we'll open the phones.

REHM

10:40:03
And welcome back. It's time to go the phones for your questions. 800-433-8850. First, to Homer, Mass. Jason, good morning. You're on the air.

JASON

10:40:19
Thank you for having me on the air.

REHM

10:40:21
Sure.

JASON

10:40:23
I've got more of a comment than a question.

REHM

10:40:26
Okay. Make it brief, please.

JASON

10:40:30
Yes, ma'am. I think this is, in short, gross misconduct on the part of the FDA. Their -- the datasets are the datasets. There's plenty of them. You know, there's arguments that could be said for and against genetically modified salmon. But with the amount of growth hormones put in our peas, in our milk and the radiated chicken, everything that were said as consumers and the act -- the Food Safety Act -- that's about to go into the Senate for deregulation of organic food and everything else that goes along with that. I think this is ridiculous.

REHM

10:41:18
All right, sir. Thanks for your call. What do you think, Andrew Pollack, in terms of the amount of work that the FDA itself has done on this? Or is it not the FDA but those who are interested in putting these genetically altered fish before the public?

HANSEN

10:41:43
Well, the studies were done by the company, by and large. Part of that is this is being handled as an animal drug, which is a little bit of an odd way to do it. But it seems that is the best thing the FDA thought they could come up with without a whole new legislation for regulating genetically engineered animals. Under a drug application for human or animal drug, the drug company does the studies to tell whether the drug is safe and effective, and then the FDA vets them. And that's how this occurred.

REHM

10:42:15
I still have a question about the need for this genetically altered salmon. You, Val Giddings, are saying that this would bring down the price, offer these genetically-altered salmon at lower prices. Is that the point, and therefore, place this fish more abundantly before the public?

GIDDINGS

10:42:45
The first thing this would do would be to increase the abundance of salmon in the market. That usually results in a decrease in price. More importantly, I think, making more farm salmon available to help meet the demand will reduce the pressures on wild salmon which are largely being harvested at unsustainable rates. The Food and Agriculture Organization of the United Nations tells us -- and all fishery scholars agree -- that, virtually, every fishery on the planet is overstressed, is being fished at unsustainable levels and the -- yet the demand for fish keeps rising. So we have to find more ways to produce more under cultivated or domesticated situations just like this.

REHM

10:43:25
All right. To Jenny who's in Roseburg, Ore. Good morning. You're on the air.

JENNY

10:43:32
Hi. I'm sorry there isn't an independent fisheries biologist there to speak to the situation of the pressures on wild salmon because I think the human issues are the least of the problem. Really -- to take the words of your guest there -- there has been no other salmon in the history of the planet that has grown consistently throughout its entire lifecycle. And you said that it's a -- (unintelligible) was a -- what was genetically altered. He said it was a piece of another ocean fish was added. He didn't say which ocean fish. It's clearly not a fish that the salmon would naturally mate with or in any time in evolutionary history, was not an (word?) fish.

REHM

10:44:18
All right.

GIDDINGS

10:44:19
It was...

REHM

10:44:19
Val, do you want to respond to that?

GIDDINGS

10:44:21
It was the -- the fish is called an ocean pout. It's an eel-like fish from the Atlantic.

REHM

10:44:26
An eel-like.

GIDDINGS

10:44:27
An eel-like fish. And...

JENNY

10:44:29
Right. So a salmon would not cross with an eel, and an eel is not (word?). And the -- I mean, I just think it's a slippery slope to put -- once you start to say that a salmon crossed with an eel is materially the same as any other salmon, then why not have breeding stock? And at what point does this just say, okay, well, we'll just breed these things because we've decided isn't -- humans aren't allergic to it.

REHM

10:44:53
All right. Val, do you want to respond?

GIDDINGS

10:44:54
The most -- yeah, the most common gene in the human genome is a viral DNA sequence. Our genomes are full of DNA that came from other genetic lineages. There is nothing contrary to nature. Indeed, what we find in nature is that this is ubiquitous. The real issue is what does the -- what impact does this have? We can detect the impact. We can measure the impact, and it presents, as FDA has said, no risk to food consumption.

REHM

10:45:21
Michael Hansen, do you want to comment?

HANSEN

10:45:24
Yes. I would just point out that on the advisory committee there was only one scientist who had a background in fish. Okay? That one scientist -- his conclusion in terms of the environmental, he asked for a full environmental impact statement. So the only fish scientist on the committee asked for a full environmental impact statement. That's how concerned he was. That would be a two-year process. There are serious environmental issues as any fishery scientist will point out.

REHM

10:45:55
All right.

HANSEN

10:45:55
And again...

REHM

10:45:56
All right. Let's go now to Miami, Fla. Good morning, Mike.

MIKE

10:46:01
Good morning. Thank you for having me on the air.

REHM

10:46:03
Sure.

MIKE

10:46:03
I would just like to make a quick point and then ask both of your guests a question that they can both respond to. One is I think the corporate consultant needs to admit, that thing we have here, that they don't really know. There's no computer models. They know this fish will get out. It's voracious. It's aggressive. It may indeed push natural salmon to the point of extinction or endangered species status because we know that once these living things are released into the wild that they are going to mix with the wild population, and it's inevitable. So I think the corporate consultant needs to admit that they don't know everything. They don't know the impacts of everything. They didn't know they've done the protein studies. They've done this study...

REHM

10:46:45
All right. And your question, please?

MIKE

10:46:47
And the environmental scientist needs to admit that you can't put the genie back in the bottle. We are going to tinker with genes, period. That's going to happen. And I think what we need here is a national respect for science, so whether it's global warming or stem cell research or this -- the FDA is incapacitated and unable to handle this kind of things. We have a Republican assault on science, and I would like both of your guests to chime in on the idea that we need a national respect for science and a national policy to deal with these enormous questions.

REHM

10:47:19
All right. Thanks for your call. To you, Val, the corporation and those who did the studies, those who are pushing for this, don't really know what could happen in the future assuming that this kind of fish does get out into the wild.

GIDDINGS

10:47:44
Diane, I worked for 10 years as a regulator for USDA, and I always assumed that containment measures would fail. And we had to figure out what the consequence would be when they did. One thing we do know is that if this fish got out -- not only if this fish got out, but if this fish were raised in sea pens so that the certainty of substantial escapes were 100 percent -- we know that the risks to wild fish -- wild salmon would be dramatically reduced over the status quo we see today.

REHM

10:48:12
How do we know that?

GIDDINGS

10:48:13
Because this fish is at least 98 percent sterile, and fish that are farmed today are 100 percent fertile. If this fish were to get out, they don't have the ability to mate. They don't show spawning behavior. They don't swim upstream to spawn. Mr. Hansen misstated their foraging behavior. They don't know how to hunt for food in the wild. If these fish see a shadow on the surface of the water, they rise because they've learned to associate shadows on the surface of the water with the imminent arrival of lunch.

REHM

10:48:43
All right.

GIDDINGS

10:48:43
A wild fish heads for the deepest hole because they know it's likely to be a predator.

REHM

10:48:48
All right.

GIDDINGS

10:48:48
This fish reduces the risks that wild fish face. It answers all the questions that environmentalists have had over concerns about farmed pin salmon. And the data show this very clearly. Do we know everything? No. But that we do know with certainty.

REHM

10:49:02
Michael.

HANSEN

10:49:04
I would point out that there is many papers in the scientific literature from scientists who studied this, raising the concerns about the change in behavior. Yes. There would be less what Val calls predator avoidance, but they need to see what the balance is. And they're very concerned, so there's a real issue there. I would also point out that to produce the eggs, you have to have fertile engineered fish. That's what they have up in Canada, and that facility where they have them is less than a 100 meters from the water. So if they do get out, there are serious environmental concerns that...

REHM

10:49:45
But on...

HANSEN

10:49:46
...that people have.

REHM

10:49:46
...Mike's point, Michael, isn't the genie already out of the bottle in terms of these studies that have created these blends, whether it's in...

HANSEN

10:50:03
Well...

REHM

10:50:04
...plant life or animal life?

HANSEN

10:50:07
That's correct. We do have a lot of genetic engineering out there. And there's actually been global agreement that there should be required safety testing before the products come on the market.

REHM

10:50:17
And...

HANSEN

10:50:17
Unfortunately, we don't require that in the U.S. I agree absolutely with Mike that we need a national respect for science and that these evaluations should be done on a scientific basis. That is not what is happening now 'cause Dr. Giddings tried to say, yes, there's 30 data tables in here. But for the growth hormone itself, they did not detect it in any of the fish, in the flesh of the fish. If you would ask him that narrow question, the data is clear cut. It's in table 15. Not a single fish, could they detect the growth hormone -- not other things -- the growth hormone which was an identified hazard. They could not detect it.

GIDDINGS

10:51:02
And the best analytical available methods -- the best analytical methods available failed to find it. And therefore, Dr. Hansen concludes that...

HANSEN

10:51:08
(unintelligible)

GIDDINGS

10:51:10
...that it's present at dangerous levels. Zero is a number. You know, these levels are clearly below any action of a level of concern. That's what FDA concluded. That's what the data show.

REHM

10:51:20
All right. And joining us now from his office on Capitol Hill is Congressman Dennis Kucinich of Ohio. Good morning, sir. I know you wanted to join the program. You have a bill that you'd like to see pass in regard to this kind of genetic operation?

REP. DENNIS KUCINICH

10:51:47
Well, I have a several bills, but the prime one has to do with labeling of genetically engineered products. Diane, it's been said that we are what we eat. Well, if indeed we are what we eat, then we ought to know how the food that we're eating is made, so we'll know what we will be become. And there are so many unknowables about genetically engineered products that the prudent -- the precautionary thing to do would be to make sure that it's labeled and let the consumer make his/her own decision.

REHM

10:52:16
So from your perspective, what you want to make sure that's done if this fish goes forward, is that consumers know exactly what they're eating.

KUCINICH

10:52:29
Well, there are hundreds of millions of acres of genetically engineered crops that have already been planted. There are many genetically engineered products that are already out there. The discussion about genetically engineered fish only reflects on a larger question about people's right to know how their food is made. And when you go back to the FDA's first permission given to produce genetically engineered products, they claimed at the time in 1991 -- 1992, that genetically engineered food products were the functional equivalent of conventional food. They did that without any -- providing any data with respect to allergenicity, toxicity, functional characteristics, antibiotic resistance. And so what I'm working on is to make sure that any genetically modified products are required to have a label.

REHM

10:53:19
Okay. But let me take you back one step. Do I understand correctly that you are urging the FDA to delay a verdict on whether to allow genetically engineered salmon to go forward?

KUCINICH

10:53:36
Well, absolutely. I mean, the FDA really doesn't have data that shows a reasonable certainty of no harm, and their Veterinary Advisory Committee didn't give an answer. And, you know, yesterday's hearing was on whether the label -- the GE salmon if approved. And, you know, there's -- they just -- they're wading into an area where there are so many risks that are not only known, but they're unknown risks, and Americans have a right to know what they're eating. And the buyer can't be aware if the buyer isn't informed (unintelligible).

REHM

10:54:10
So what is your view? Do you think the FDA is going to go forward immediately? Or are they going to wait?

KUCINICH

10:54:20
I'm not sure what the FDA will do, but they have a great responsibility here. And, you know, I'm just -- I'm concerned that we're going to get into another situation where a regulatory agency gets in bed with a major industry, and the American people get hurt. And, you know, that's why I'm having a subcommittee hearing on -- as chairman of Domestic Policy Subcommittee, we're going to have the first hearing held by Congress to determine the environmental impact of the evolution of herbicide-resistant weeds in fields growing genetically engineered herbicide-resistant crops. We're looking at the super weeders.

KUCINICH

10:54:52
And, you know, we're going to continue to look at any areas where the natural world is being tampered with. I mean, this is -- there's a philosophical issue behind this, too, and the attempt to essentially play God by interfering in the natural world. And there are consequences for that.

REHM

10:55:17
Congressman Dennis Kucinich of Ohio. Thank you so much for joining us.

KUCINICH

10:55:24
Thank you very much, Diane.

REHM

10:55:26
And, Val Giddings, I'm going to give you the last word. You've just heard Congressman Kucinich say he wants the FDA to delay its decision.

GIDDINGS

10:55:37
What Mr. Kucinich failed to say is that of the 2 billion crops of genetically -- 2 billion acres of genetically engineered crops that have been grown to date, there has been not a single solitary instance of a negative health or environmental consequence from this. Biotech crops have been shown to be at least as safe as, and in many cases, safer than their conventional counterparts.

REHM

10:55:59
But we're talking about fish here.

GIDDINGS

10:56:00
Biotech crops and biotech fish...

REHM

10:56:03
We're talking about fish here.

GIDDINGS

10:56:04
Biotech crops and biotech fish have been subjected to a level of scrutiny that has never before been applied to foods in history, including organic foods. And many organic foods would fail those tests. FDA has not found any potential hazard associated with this fish. The Veterinary Medical Advisory Committee failed to identify any new hazards that were not already identified and examined by the FDA. FDA's conclusions stand as solid and supported by the fact. They look for direct food consumption hazards. None were found.

REHM

10:56:34
Val Giddings, he's president of PrometheusAB, a former consultant to AquaBounty, the company attempting to bring genetically altered salmon to the market. The FDA is considering whether to move forward now or not. Andrew Pollack is a biotechnology reporter for The New York Times, and joining us this morning from a studio in New York, Michael Hansen of Consumers Union. Thank you all so much. Thanks for listening. I'm Diane Rehm.

ANNOUNCER

10:57:14
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