Moderator: Welcome to Viewpoint with our guests, Michael Fernandez, Eric Hallerman and Elliot Entis. Michael, Eric and Elliot, we're glad to have you with us. What are genetically modified fish, and why are they in the news?
Michael Fernandez, Eric Hallerman and Elliot Entis: Thanks and we're all glad to be here. Transgenic fish (also known as genetically modified or genetically engineered) are created by taking DNA from one source -- a different kind of fish, a different animal, a plant, or even a bacterium -- and putting it into a fish to give it some new property that you want. We have had several years of experience with genetically engineered crops such as corn and soybeans, but fish could become the first genetically engineered animals on the market. The Food and Drug Administration is currently reviewing one such product, a faster growing Atlantic salmon that was developed by AQUA Bounty Farms.
Baltimore, Md.: With the use of transgenic fish that are sterile, what harm to the environment, if any, would you expect?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) With the use of sterile transgenic fish, we would expect the net environmental effect to be positive in comparison to present practices of growing fertile nontransgenic fish in ocean net pens. One of the most significant issues raised by environmentalists is the potential for negative effects on wild stock posed by “gene flow” (created by mating). Use of sterile fish will eliminate this issue. In any event, prior to commercial use of our fish, environmental impact assessments will be carried out and risks assessed.
(EH) We have to ask if transgenic fish pose any ecological hazards that are not posed by nontransgenic fish. For instance, if transgenic fish might prove superior competitors or predators than nontransgenic fish. With current knowledge, it’s very difficult to make defensible predictions.
Clarksville, Md.: When is AQUA Bounty going to start selling its transgenic salmon? With the recent low prices for salmon, will the market be sufficiently profitable?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) We are going to start selling our salmon once it’s approved and has gone through the regulatory process. We’ll do some initial small-scale market testing. We expect the first AquaAdvantage salmon, in any reasonable numbers, to appear within two years following regulatory approval. Our target is roughly 2005.
Blacksburg, Va.: Compared to Atlantic salmon bought in the grocery store, how much of a price difference, if any, may the consumer of genetically-modified (growth hormone enhanced) salmon experience?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) The cost of production of geneetically modified salmon will be considerably lower than present costs. We would expect the savings to be apportioned between producers and consumers. Estimates are that production costs decrease by roughly 30 percent.
Wuhan, China: I want to know if the genetically modified fish are safe. Some study denoted that some genetically modified mouses suffered various unpredictable disease; is it as same as with fish? Will it give bad effect to us if we eat this kind of fish?
Michael Fernandez, Eric Hallerman and Elliot Entis: (MF) There isn’t really one answer to this question. Each kind of genetically modified fish will have to be looked at separately. In the United States, it is the Food and Drug Administration (FDA) that will decide whether they are safe to eat, and nobody will be allowed to sell genetically modified fish until they can prove to FDA that the fish are safe. FDA has a lot of authority to get all the scientific data it needs to make a decision, and they have a long history of assuring the safety of our food supply.
(EH) In a recent study, a committee of the National Research Council considered the food safety of fish expressing a new growth hormone gene and found that it posed only a low level of food safety concern. The report is entitled "Animal Biotechnology: Science-Based Concerns" and is available from the National Academy Press at www.nap.edu.
(EE) Our salmon only produce salmon growth hormone. No foreign growth hormones have been introduced into these fish. The essential difference between our fish and nontransgenic fish is the timing and location of growth hormone production. Data indicates that the level of growth hormone in our fish is indistinguishable from that of standard salmon. Further, we know that fish growth hormone is not bioavailable to human beings. Therefore, we anticipate no difference in food safety between our fish and other salmon.
Sleeping Bear Dunes, Mich.: What is the regulatory review process? Is it a state or federal process? If federal, how many federal agencies are involved? How long does the process take?
Michael Fernandez, Eric Hallerman and Elliot Entis: (MF) Both states and the federal government have some authority. At the federal level, the FDA has primary authority to review and license transgenic fish. There is currently no official guidance by the federal government on how transgenic fish will be reviewed. At the present time, these products are being regulated under existing statutory authority. Federal biotechnology policy was established in the mid-1980s and it was decided at that time that no new laws were needed to regulate the products of agricultural biotechnology. Instead, in 1986, the Coordinated Framework for Regulation of Biotechnology was established, requiring three federal agencies (the FDA, the Department of Agriculture and the Environmental Protection Agency) to use at least 10 different laws and numerous agency regulations and guidelines to address biotechnology products. Each of the laws currently used was developed before the advent of biotechnology products and reflects widely different regulatory approaches and procedures.
(EE) Federal regulation of transgenic fish is governed by the Food, Drug and Cosmetics Act. As far back as 1986, the U.S. Food and Drug Administration asserted jurisdiction over transgenic animals and fish on the grounds that the transgene and any expressed proteins affect the “structure and function” of the receiving animal analogous to the modalities of alternative veterinary drug formulations. FDA jurisdiction has been upheld by the federal courts. In other words, we are being regulated as a new animal drug which are the most difficult standards to meet -- just like in the kosher hot dog ads "we answer to a Higher Authority."
Davis, Calif. : Do you plan to label the genetically engineered salmon ?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) Yes, we plan to label. Our company has consistently been in favor of clearly identifying our products as having used modern biotechnology processes in their development. We believe that labeling is a plus for the consumer and the producer and that this will create greater confidence in an excellent product.
Moline, Kan.: When are catfish farmers going to have a fast-growing fish?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EH) Faster-growing channel catfish lines have been produced by selective breeding by Auburn University and by the USDA. For example, the USDA-103 Line has been released to aquaculturists in the last several years and is becoming quite popular. In the context of today's discussion, transgenic catfish expressing an introduced growth hormone gene have been developed by Auburn University but have not entered commercial production.
Brownsville, Texas: Are there any environmental or health benefits to using genetically engineered fish?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) In addition to eliminating gene flow problems through the use of sterile animals, our transgenic salmon eat less to gain more weight, hence are more sustainable. Also, as the production of salmon increases, the ability to grow twice as many fish in a given area in a given time (because the grow-out time is cut in half) means that less coastal space will be needed for this industry. Finally, the improved cost-efficiency of producing transgenics allows for the first time the economical production of salmon in indoor facilities entirely separate from the ocean waters.
Michael Fernandez, Eric Hallerman and Elliot Entis: To add to the previous answer:
(EH) This is an appropriate context for asking serious questions about the efficacy of sterility induction. Will all of the animals that have been subjected to triploidy induction indeed prove triploid (i.e., sterile)? Reproductive confinement can be ensured if the fish themselves are physically confined in a recirculating aquaculture system.
Columbia, S.C.: When you say the fish are sterile, does that mean they will never produce eggs and sperm, or that if they spawned, the resulting embryos would not develop to hatching?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EH) You have to consider this on a species-by-species basis. In the case of salmonids, we know that the females have minimal gonadal development and have not been known to produce viable eggs. The males, however, undergo gonadal development, may show spawning behavior, and do produce sperm. Should they fertilize eggs, the young would all die because they would have unmatched chromosomes and the entire brood would be lost.
(EE) We are applying for regulatory approval to commercially grow only all-female sterile salmon.
(EH) We would have to ensure that the females are all triploid and hence all sterile.
Boerne, Texas: The FDA has been relying on industries' data. Where are the scientific results and what tests are being done?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) In our submissions to the FDA, we utilize independent, third-party contract labs that meet FDA standards established to approve drugs. These laboratories are producing data on vitamin, mineral, hormone, and amino acid levels to determine whether or not our salmon are equivalent to existing salmon. These labs have no stake in the outcome of the tests. They are entirely independent and their data is submitted to the FDA without alteration by industry. To date, initial data indicate that our salmon are entirely equivalent to those fish currently being grown in aquaculture settings.
Baltimore, Md.: What is the short and long-term prospect for the development of genetically modified shrimp? How is the taste of this shrimp likely to compare with fresh shrimp caught off the Carolina and Florida coasts?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EH) In the short term, shrimp biotechnologists will have to overcome a technical difficulty that has plagued them for at least five to seven years. That is, they have been able to introduce a gene into a crustacean but they have not been able to insert the gene into the germline. In other words, these transgenic crustaceans have not been able to pass the new gene to their offspring. Until this problem is solved, transgenic lines with favorably altered traits remain only a technical possibility. Lines of transgenic crustaceans are a long-term prospect and none are near commercialization.
Brooklyn, N.Y.: What precautions are in place to prevent allergic reactions to the essentially new substances you are introducing into the food supply? Please consider the large numbers of allergic folks who suffer -- sometimes needing to rush to the emergency room! -- after eating foods that "used to be" safe but have been genetically altered with no warnings on the packaging. This is potentially life-threatening -- anaphylactic shock and sudden allergy-caused asthma attacks can be deadly.
I read an article stating that generations ago, free-ranging animals produced red meat that humans consumed a great deal of. Yet even though this meat was a main staple of their diet, its composition differed from today's red meat (including fat and cholesterol content, which was considerably lower). Consequently, people who ate all that red meat back then were healthier than people today who eat the same amount of it -- except for some people in remote parts of Africa whose meat sources still roam freely. I read that this "free-ranging" meat has been tested and found to have a better ratio of protein to fat than the domestic animals we eat. How can you insure that breeding fish in captivity won't change their chemical composition, too (perhaps replace "good fatty acids" with cholesterol or triglycerides)?
Michael Fernandez, Eric Hallerman and Elliot Entis: (MF) The possibility that a “new substance” could cause an allergic reaction is one of the key food safety considerations. There are some methods for testing for allergens, but they are not perfect. We definitely need more research on methods to better predict whether a new substance would cause an allergic reaction.
It is important to point out, though, that the developers of new foods also understand these concerns. To help reduce the chances that a new food could cause a problem, they are using sources of new material with which we have a lot of experience already. In other words, if you get a gene from something that you know doesn’t cause an allergic reaction, the chances that it would in a new food are much smaller.
Also, biotechnology holds the promise of reducing the allergenicity of some foods. For example, researchers have figured out what causes many people to be allergic to shrimp. They are discussing how to genetically modify shrimp so that it doesn’t cause allergic reactions.
(EE) In addition to testing for all other nutritional elements of our salmon, we are also contracted with independent labs to determine if our transgenic salmon have a different allergenic profile from other salmon. This is part of the data set to be submitted to FDA. Considering that no new proteins or hormones have been introduced to our salmon, we can reasonably believe that the results of such testing will show no difference.
Rockville, Md.: Is this technology expected to limit or eventually eliminate the commercial fishing industry?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) Current research clearly shows that we are overfishing the oceans. According to the FAO (the UN's Food and Agriculture Organization), the World Fish Center and the International Food Policy Reasearch Institute, only strong growth in aquaculture can prevent a strong increase in price and decrease of fish available to the developing world, as well as the developed world. The FAO has estimated that aquaculture will have to increase several-fold over the coming 20 years in order to maintain current per capita consumption of fish. The alternative would be a disastrous reduction in the biomass of the oceans through overfishing.
(EH) The experience of fisheries managers worldwide is that populations will be exploited as long as they are commercially viable. Hence aquaculture will always complement -- not replace -- capture fisheries.
Kingston, R.I.: Will transgenic fish taste more like wild fish than traditional aquacultured salmon?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) Blind taste tests conducted on our salmon have shown no difference between AquaAdvantage and other farm-raised salmon. Much of the taste quality in farm-raised fish is related to the feed given to them.
Salina, Kan.: How could NADA be changed to allow for more transparency during the approval process?
Michael Fernandez, Eric Hallerman and Elliot Entis: (MF) The concerns about transparency of the regulatory approval process are important ones. The process as it stands now does not allow FDA to disclose information to the public before a decision to approve the product is made. We recently issued a report, "Future Fish: Issues in Science and Regulation of Transgenic Fish," (www.pewagbiotech.org) that questions whether the Agency’s review process provides the necessary levels of transparency and public participation needed to ensure public confidence. Everyone recognizes that this is a concern. Other than changing the law, it is unclear how greater transparency can be brought to the system.
Livonia, Mich.: Do you expect to market in countries other than the U.S. in 2005? What other country is willing to approve the sale of genetically modified fish?
Michael Fernandez, Eric Hallerman and Elliot Entis: (EE) We are not going to be raising salmon for commercial use ourselves. Our company will be acting as an egg and young fish supplier to other companies that produce salmon for consumers. Each country has and will have its own rules regarding the conditions under which these fish can be grown. This is a rapidly evolving situation. As the rules and regulations of each country allow, we anticipate supplying local farmers with our product. There are other countries already developing transgenic fish and we expect this field to increase in size.
Washington, D.C.: One of the previous questions inferred that people have been getting sick from genetically modified foods. Is that true?
Michael Fernandez, Eric Hallerman and Elliot Entis: (MF) We would like clarify something that was posed in a previous question from Brooklyn (not our answer). It was inferred that people are getting sick from genetically modified foods currently on the market. That is certainly not the case -- there is no evidence to suggest that any consumers have suffered allergic reactions or any other adverse reactions to genetically modified foods.
Michael Fernandez, Eric Hallerman and Elliot Entis: Thanks again for giving us the opportunity to communicate with everyone. Unfortunately, time does not allow us to answer all your questions. We appreciate your input and hope that we have helped to further the discussion of transgenic animals and food. For more information on transgenic fish, please download the Pew Initiative's report "Transgenic Fish: Issues in Science and Regulation of Transgenic Fish" at www.pewagbiotech.org/research/fish or go to Aquabounty's Web site at www.aquabounty.com.
Moderator: Our thanks to Michael Fernandez, Eric Hallerman, Elliot Entis, the Pew Initiative on Food and Biotechnology and all who participated.