New Salmon Can Address a Myriad Of Problems

By Elliot Entis, co-founder of AquaBounty Technologies

(From The Hill, Friday, October 8, 2010) 

Natural fish stocks have been so depleted in the past few decades that more than half of the salmon we consume here in the United States comes to us from “fish farming,” 97 percent of which is imported. That’s because we consume highly-desirable fish like salmon at least twice as fast as it can reproduce in the wild.

In 1993, AquaBounty, the company I founded, began discussions with the Food and Drug Administration (FDA) to approve an Atlantic salmon hybrid we developed that could grow to maturity much faster, in contained local facilities, dramatically reducing the carbon footprint of production and overfishing that plague our current salmon consumption, while helping to restore a domestic industry in the U.S.

The accelerated growth is achieved by adding a gene from the Chinook, a close relative of the Atlantic salmon, and a piece of DNA from another food fish, the ocean pout, which acts as a switch to “turn on” the Chinook salmon gene. The result is that the Atlantic salmon grows faster, and reaches harvest size in half the time while consuming less feed. Both our domestic economy and the environment gain from this advance.

Given the novelty of the product, the FDA review process uses the new animal drug (INAD) approach based on the Federal Food, Drug and Cosmetic Act. The new animal drug approach reviews, “articles (other than food) intended to affect the structure or any function of the body of man or other animals” (FD&C Act, Ch.II, Sec.201.g).

The animal drug approval process — whether applied to a traditional drug or to a novel drug — is the gold standard around the world, and we enthusiastically support this documented, rigorous, trusted process.

The review process used by FDA on the AquAdvantage salmon is more rigorous, detailed, and extensive than that applied to any other fish in history. And now, after 15 years of testing, and reviews by dozens of scientists, the government has concluded that “Aqua Bounty salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia.  All other assessments of composition have determined that there are no material differences in food from [AquaBounty] salmon and other Atlantic salmon.”  

In other words, the “true nature” of this salmon is that it is a salmon, indistinguishable in every material aspect from any other Atlantic salmon. To suggest otherwise would be false advertising; it would suggest a difference that does not exist.

The application of technology to agriculture is nothing new. From the beginning of time, man has used selective breeding to develop heartier crops and livestock with desirable traits. Thanks to modern agriculture technologies, we can more efficiently and sustainably produce food and fiber for a growing population.

In the case of genetically engineered salmon, technology enables us to precisely apply genomic knowledge to improve the rearing of salmon and the production of a high quality food.

Today, the majority of the food we consume has been modified in some way and most contains genes from two or more species of plant or animal. Among these are farm-raised striped bass, corn, and tomatoes – none of which is specially labeled.

So if we routinely add genes from one species to another through traditional farming methods, is there a rationale for singling out this salmon from the literally thousands of other products whose genes have been altered to enhance our ability to produce tasty, plentiful, nutritious food?

If we take time to learn the facts, understand the science, and resist the temptation to rely on conjecture and emotion, we can all appreciate new advances in our ability to produce healthy, sustainable food with the confidence that it has been vetted by the scrutiny of the world’s best science.

Innovation will be key to meeting the challenges of feeding a growing world population and maintaining a strong, domestic agriculture base.

Don’t Be Afraid of “Frankenfish”

The Wall Street Journal ran on September 23, 2010, an op-ed authored by BIO President and CEO Jim Greenwood about FDA’s pending approval of a genetically engineered salmon.  This salmon can help meet the growing demand for protein-rich food without depleting wild fish stocks.

Right now, the government is deciding whether it’s safe for us to eat genetically engineered salmon. The fish, called AquAdvantage, is being developed by a Massachusetts biotech firm and is in every measurable way identical to Atlantic salmon—except it grows to normal size twice as fast. If officials at the Food and Drug Administration (FDA) give it the green light, it would be the first time that a genetically engineered animal is approved for food use.

Genetic engineering usually conjures up images of Frankenstein. But modern day biotech researchers are anything but mad scientists. Their ground-breaking work has the potential to address world hunger and protect the environment. The AquAdvantage salmon in particular could ease pressure on wild fish stocks, reduce the environmental impact of traditional fish farming, and help feed the growing world population.

Overfishing and pollution are quickly wiping out the native global fish supply. Already 80% of fish stocks world-wide are fully exploited or overexploited, according to a May 2010 U.N. report. If current trends continue, virtually all fisheries risk running out of commercially viable catches by 2050.

Fish farming has helped address this problem: About half of seafood consumed world-wide is now farm-raised. But it’s expensive. Shipping farm-raised salmon to the United States from Chile, where most of our fish originates, costs as much as 75 cents per pound.

Faster-growing genetically engineered salmon could help restore America’s domestic fish farming industry, trimming costs and reducing energy consumption. If the FDA approves the fish it would also spur investment in other food products. This could help meet the world’s growing demand for protein-rich food.

Through biotechnology, scientists at a firm in South Dakota have developed cattle that are resistant to mad cow disease. Canadian researchers have asked the FDA to approve their “Enviropig,” a pig genetically engineered to produce manure that is less polluting. Biotech researchers are also exploring ways to fortify food plants with enhanced nutritional content, which could help alleviate malnutrition and certain diseases in the developing world. And researchers are engineering animals that can better utilize nutrients in feed.

Critics contend that genetically engineered fish haven’t been sufficiently researched and could harm our health. But the truth is that these faster-growing salmon are the result of more than two decades of research. Plus, the FDA’s system to ensure the safety of such animals has been in development for over a decade.

There’s nothing peculiar about this fish’s genetic makeup. To create the faster-growing salmon, scientists took a gene from the Chinook salmon, which matures rapidly, along with a gene from a salmon relative called ocean pout, which produces growth hormones all year. Aside from these two tweaks, the AquAdvantage salmon is chemically and biologically identical to the salmon we purchase at the local grocer.

Critics also fear that these salmon could crossbreed with wild fish and pollute their gene pool. This is highly unlikely given the protections put in place and the realities of the science. By treating the genetically engineered eggs, all AquAdvantage salmon will develop as sterile females. And these fish will be grown in contained, land-based tanks, away from any interaction with wild fish and the ocean.

When genetically engineered crops were introduced 14 years ago, critics worried that “frankenfood” would hurt human health and the environment. Since then, farmers have grown corn, soybeans, cotton and other products that are resistant to disease and pests, and tolerant of herbicides. These innovations have reduced production costs, increased agricultural productivity and reduced agriculture’s footprint on the environment. To date, not a single adverse health effect has been caused by a food derived from genetically engineered crops.

Genetically engineered animals are the next intelligent step in food innovation. As Josh Ozersky, a James Beard Award-winning food writer, has observed, “There are no Black Angus cows grazing in the wild; they’re the product of breeding for size, marbling and fast growth, not unlike the genetically-modified salmon.”

Public dialogue on any new technology is important. But the discourse must be based on sound science. And regarding faster-growing salmon—and other genetically engineered foods of the future – science shows clearly that they can provide us with the safe and sustainable food source we need.

Science Advisory Board Has Rigorous Discussion on GE Salmon

FDA Approval Could Pave the Way for Future Science-based Technologies

 As part of the U.S. Food and Drug Administration’s rigorous, scientific regulatory review governing genetically engineered (GE) animal technologies, the FDA’s Veterinary Medicine Advisory Committee (VMAC) hosted a rigorous discussion about a GE salmon on September 19-21.

 The AquAdvantage® Salmon is genetically engineered to reach its market weight in half the time of conventionally raised salmon thus contributing to more sustainable aquaculture systems.  It was developed by Massachusetts-based AquaBounty Technologies, a Biotechnology Industry Organization (BIO) member.

BIO President and CEO Jim Greenwood applauded the VMAC’s recommendation and the FDA process for assuring the safety and efficacy of GE animal products.  

“Over the years, innovations in agricultural biotechnology have helped improve farmers’ lives, lessen agriculture’s impact on the environment and contributed to a more sustainable food supply for a growing world,” says Greenwood.  “As the FDA considers its first genetically engineered food animal, we’re hopeful that this process will pave the way for future technologies currently in the pipeline.” 

 “FDA is the world leader in science-based reviews of products benefiting human and animal health, and the regulatory process for GE animals finalized by FDA in January 2009 is the gold standard for how to bring these products to market in a safe and science-based manner,” Greenwood added. 

The VMAC is tasked with reviewing and evaluating data on the safety and effectiveness of new animal drugs for use in the treatment and prevention of animal diseases and increased animal production, and making appropriate recommendations to the FDA Commissioner regarding scientific issues and regulatory policies.  

As part of the VMAC discussion, evidence and testimony was presented today by independent experts about the salmon’s safety, effectiveness, and environmental benefits based on data from 14 years of scientific study. 

“The application of technology to animal agriculture is not something that is new.  It has allowed us to more efficiently and sustainably produce food and fiber for a growing population,” said Dr. David Edwards, BIO’s Director of Animal Biotechnology, in testimony before the Committee earlier today. “The application being considered today is an extension of technology that precisely applies our genomic knowledge to improve the rearing of salmon and the production of a high quality food.” 

The first U.S. approval for a GE animal product came in February 2009 when the FDA approved ATryn®, a therapeutic protein derived from the milk of goats genetically engineered to produce recombinant antithrombin.  

“GE animals have already realized the promise of advancing human health, and now this technology could lead to more sustainable and environmentally friendly food production,” says Edwards.  “Other new technologies in development include GE cattle, goats, pigs and fish that can advance human health, mitigate environmental impact, optimize animal welfare, improve state-of-the-art industrial products and provide sustainable food sources in agriculture and aquaculture.”

For More Information

Modified Salmon Is Safe, FDA Says

Hundreds of media outlets reported on the analysis and other materials related to the AquAdvantage salmon that was released by FDA September 3. Mainstream media coverage included articles in The New York Times, Los Angeles Times, Washington Post, Denver Post, Discover Magazine and CNN, which also posted an online video news clip.

A salmon genetically engineered to grow quickly is safe to eat and poses little risk to the environment, the Food and Drug Administration said Friday. The assessment makes it more likely that the fish will become the first genetically engineered animal to enter the American food supply.

Food from the salmon “is as safe as food from conventional Atlantic salmon,” the FDA said in its analysis, which was posted on its Web site Friday. “There is a reasonable certainty of no harm from consumption of food from this animal.”

The salmon can grow to market size in 16 to 18 months instead of the 30 required for a regular farmed Atlantic salmon, according to its developer, AquaBounty Technologies of Waltham, Mass. AquaBounty has been trying for years to win approval for the salmon, a goal that now appears within reach. The analysis by the FDA staff was in preparation for three days of public meetings on the salmon that will start on Sept. 19. The FDA is expected to make a final decision on approval in the weeks after the meetings.

A coalition of anti-industry groups voiced opposition to the approval last week, citing, in particular, concerns that the salmon could escape and possibly outcompete wild salmon for food or mates. But AquaBounty said the fish would be grown only inland. And only sterile females will be sold, limiting any ability to reproduce. The FDA, in its analysis, basically agreed that the chance of escape or ecological disruption was small. The salmon “are not expected to have a significant impact on the quality of the human environment,” it concluded.

Jerry Pommer: Livestock Biotech Conference Preview

BIOtech Now visited with Jerry Pommer, Director of Animal Regulatory Compliance and Quality Assurance for Hematech, Inc. in Sioux Falls, South Dakota. Jerry is a member of the program steering committee for BIO’s first-ever Livestock Biotech Summit, which  will provide participants with three days of cross-cutting discussions among industry, academic and government leaders on the care and use of animals in research and the many possibilities in the realm of GE animal research, regulation, and funding within the biotechnology industry. Jerry discusses the unique draw and expectations for the conference, in addition to the GE animals that will be spotlighted – including:

  • Pigs that have been genetically engineered to produce human compatible donor tissues, cells and organs;
  • Cattle that have been genetically engineered to produce human antibodies that can help prevent and/or treat a wide variety of human health conditions and diseases;
  • Cattle that have been genetically engineered to be “prion-free” and therefore resistant to bovine spongiform encephalopathy (BSE, or “mad cow disease”); and
  • Goats that have been genetically engineered to produce a spider silk fiber in its milk.  With its strength and elasticity, the spider silk has a variety of applications such as providing artificial ligaments and tendons, eye sutures, and for jaw repair. The silk could also have industrial applications in bulletproof vests and improved automobile airbags.

Listen to the podcast

FDA Sets VMAC Meeting to Consider Genetically Engineered Salmon

The U.S. Food and Drug Administration (FDA) announced today it will convene its Veterinary Medicine Advisory Committee (VMAC) to consider a salmon that has been genetically engineered to reach its market weight in half the time of conventionally raised salmon. 

The VMAC meeting, part of a rigorous regulatory process required to assess such technologies before being approved for commercialization is scheduled for September 19-20.  At this meeting, the Committee will hear from independent experts about the product’s safety, effectiveness, and environmental benefits; it will also collect public testimony and examine 14 years of scientific evidence about the salmon before deciding whether or not to recommend regulatory approval.

The regulatory process for GE animals finalized by FDA in January 2009 ensures the products made available through genetic engineering go through a rigorous review process before being approved for the marketplace.

According to the FDA,

Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.

In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.

The first U.S. approval for a GE animal product came in February 2009 when the FDA approved ATryn®, a therapeutic protein derived from the milk of goats genetically engineered to produce recombinant antithrombin.

As the FDA considers its first GE food animal this process may pave the way for new technologies currently in the pipeline.  Research with GE animals such as goats, pigs, sheep, chicken, fish and cattle has yielded a variety of products that can advance human health, mitigate environmental impact, optimize animal welfare, improve state-of-the-art industrial products and provide sustainable food sources in agriculture and aquaculture.

BIO Finalizes Impressive Program for Livestock Biotech Summit

Animal Ag Experts to Gather in Sioux Falls, September 28-30

The Biotechnology Industry Organization (BIO) is pleased to announce additional speakers and sessions for its Livestock Biotech Summit, the first national industry conference on genetically engineered (GE) animal technologies. 

Scheduled for September 28-30, in Sioux Falls, S.D., this first-ever Summit of its kind will provide participants three days of cross-cutting discussions among industry, academic and government leaders, including: 

  • Care and Use of Livestock in Biomedical and Agricultural Research:
    Kicking off the Summit, these sessions feature a lineup of outstanding presenters who are experts in each field of the care and use of animals in research.  These world-class researchers are each co-authors of the Federation of Animal Science Societies’ Ag Guide for animal research. These presentations will cover important considerations when performing research with agricultural animals, as well as sessions for individual species.  Do not miss this first-time ever presentation of the 2010 revised Ag Guide by those that wrote it!  
  • Funding Research and Development:
    A specially convened panel of diverse speakers will inform Summit participants about aspects of funding research and development. We will have presenters from the U.S. Department of Agriculture, the South Dakota Governor’s Office of Economic Development, and a private venture capital firm.  Come learn about the opportunities to fund research and development in the animal agriculture sectors.
  • Bioethics and Livestock Research:
    Recently added to the Livestock Biotech Summit program is a special section on the bioethical discussions involved in livestock research.  Wednesday morning’s thought-provoking session will set the stage for a lively day of case study discussions about care of individual animal species and the regulatory system for genetically engineered animals.  
  • Hear First-Hand from Leading Experts on Animal Agriculture:
    In addition to lively panel discussions, attendees will hear from prominent speakers such as:
    Dr. Reg Gomes, Vice President Emeritus of the University of California; 
    Bruce Knight, Strategic Conservation Solutions and former Under Secretary for Marketing and Regulatory Programs at the U.S. Department of Agriculture; 
    Dr. John McGlone, Texas Tech University;  
    Jim Greenwood, BIO President and CEO; 
    Dr. Larisa Rudenko, U.S. Food and Drug Administration. 

Complete Program Information is now available on the Livestock Biotech Summit website.  

 

South Dakota Bio Pre-Event:
In addition to the programming at the BIO Livestock Biotech Summit, the South Dakota Biotech Association will host a pre-event session on the afternoon of Monday, September 27th in Sioux Falls.  More information on this can be found about it here.

Who Should Attend?
–        IACUC Members
–        Academic & Industrial Scientists
–        Genetic Engineering Researchers
–        Regulators
–        Research Animal Suppliers
–        Drugs & Vaccine Developers/Manufacturers
–        Serum and Blood Producers
–        Biomedical Device Producers
–        Animal Disease Model Developers
–        Xenotranplantation Specialists

ARPAS (American Registry of Professional Animal Scientists) members will earn 19 CEU’s for attendance at the Livestock Biotech Summit!

Registration and Housing:
Registration is now open and attendees can register online at www.bio.org/livestockbiotechsummit
Reserve your hotel room
early and take advantage of the group discount rate of $89 per night.  Availability is limited, so act fast!

Media Registration
All programs at the Livestock Biotech Summit are open to attendance by members of the media.* Complimentary media registration is available to editors and reporters working full time for print, broadcast or web publications with valid press credentials. Valid press credentials include:

  • Official photo identification from employing news agency
  • A by-lined story from employing news agency dated within the last six months
  • A publication masthead listing you as an editorial contributor.  Freelance journalists may also apply for complimentary media registration, but must present:
    –         A signed letter on company letterhead from your assignment editor confirming your assignment to cover the event
    –         A by-lined story dated within the last six months 

*Web-based, college, and freelance reporters are strongly encouraged to register in advance. Please note that marketing executives, sales representatives, public relations executives, analysts, consultants, authors and researchers may not register as media.

BIO Acknowledges the Support Provided by the Livestock Biotech Summit Sponsors

Platinum Sponsors
Hematech, Inc.
South Dakota Governor’s Office of Economic Development
Trans Ova Genetics

Gold Sponsors
AAALAC International
Exemplar Genetics
South Dakota State University

Silver Sponsors
Animal & Plant Health Inspection Service (APHIS), Animal Care – USDA
Sigma-Aldrich
University of Illinois

Bronze Sponsors
South Dakota Biotech Association
ViaGen, Inc.

Additional information on multi-level sponsorship opportunities and program details can also be found here.

Click HERE to visit our BIOtech Now site and listen to our recent Podcast about the Livestock Biotech Summit!