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Franken Fish! Insight of the Genetically Modified Salmon and the Legislative Process in the EU and the US

Date: 6 September 2013

Course Name: 611. Legislation & Contractual Law

Author Names: Siau Vui HAN Liping ZHU

Luo Han REN Hao Hui Trevor SIU

Ming Yang LIU Hyoungjun Hahm

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Contents Introduction .................................................................................................................................................. 3

Background ................................................................................................................................................... 4

Brief History of GMO ............................................................................................................................. 4

Company background ........................................................................................................................... 5

Background of GM Salmon ................................................................................................................... 5

Scientific Research ........................................................................................................................................ 6

Scientific Research: Positive Opinions ...................................................................................................... 6

Scientific Research: Negative Opinions ..................................................................................................... 9

Environmental Impact ........................................................................................................................... 9

Food Safety Health Risks ..................................................................................................................... 10

Regulations in Europe ................................................................................................................................. 11

Public Concerns ....................................................................................................................................... 13

Civil society concerns .............................................................................................................................. 14

The US Regulatory Framework of Biotechnology ....................................................................................... 16

US Regulative process of GM Salmon ..................................................................................................... 17

FDA Approval Process: .......................................................................................................................... 18

Questioning the Credibility of the FDA Assessment ............................................................................... 19

Conflict of interest: ............................................................................................................................. 19

Limited Consultation with Independent Experts: ............................................................................... 20

Recommendations ...................................................................................................................................... 20

Credible Assessment Process .................................................................................................................. 20

Comprehensive Pilot-Test Regulation ..................................................................................................... 21

Standard Regulations on Production Process ......................................................................................... 21

Mandatory Labeling ................................................................................................................................ 22

Specific & Effective Regulations on Imports & Exports .......................................................................... 23

Conclusion ................................................................................................................................................... 23

References List ............................................................................................................................................ 25

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Introduction

The AquaAdvantage Salmon was selected by TIME Magazine as one of the ‘Best Invention of

2010’ (Walsh, 2010). Developed by AquaBounty Technologies, AquAdvantage Salmon is the

trade name for a Genetically Modified Atlantic Salmon (GM Salmon). Their purpose is to

accelerate the speed at which the fish grows, without compromising any other qualities. Their

salmon has been engineered to grow all year-round instead of only during spring and summer

(AquaBounty Technologies, 2013). The fish was claimed to grow to market in 16 to 18 months

rather than the usually tree years. The invention promises to curb with the depletion of wild

stocks due to overfishing as it serves as an environmentally sustainable alternative compared to

conventional farmed salmon (AquaBounty Technologies, 2013).

This research paper details the background and the legislative process (both in the EU and the

US) of AquAdvantage Salmon, which is still currently under the review of the United States’

Food and Drug Administration (FDA) and their Veterinary Medicine Advisory Committee. Still

in the midst of public hearings, the FDA is still determining the approval of AquaBounty

Technologies’ application for their AquAdvantage Salmon to be regarded as a regular salmon. If

the approval were granted, the salmon would become the first genetically engineered animals to

be approved for human consumption (CNN.com, 2010).

Currently the US had regulated the AquAdvantage salmon as a ‘veterinary drug’ rather than a

food product under the purview of FDA’s Veterinary Medicine Advisory Committee (VMAC).

Despite VMAC’s determination that AquAdvantage salmon is ‘as safe as food from conventional

Atlantic salmon’ (Eenennaam, 2011), there still is a number of unaddressed concerns relating to

its potential health risks such as its allergenicity or its level of insulin-like growth hormone, IGF-

1 as well as the potential environmental impacts as well. With FDA’s narrow application of

‘safety’ in which it compares one portion of GM fish to an equivalent portion of non-GM fish,

they fail to consider the full range of socio-ecogical impacts that may result from this invention.

The potential impacts of the GM salmon, both positive and negative will be further elaborated in

the following sections of the research paper.

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Should the FDA continue to lack the statutory authority to evaluate the potential impacts of

growth in the salmon market, the US Congress should in turn grant FDA the authority to

evaluate these broader impacts of food innovations and concurrently provide funding to build the

necessary capacity (Smith, 2012). Should the approval of GM Salmon come to fruition, this will

mark an important milestone for all future GM animals grown solely for human consumption As

such it is necessary to have an approval process established that will fully assess the wide

portfolio of impacts so as to ensure that the society’s best interests are served (Smith, 2012). This

research paper serves to explore the legislative themes and issues that concern the GM Salmon

and provides recommendations to curb with the identified legislative issues.

Background

Brief History of GMO

In order to improve the productivity and provide enough food for the demand of increasing

population, scientists researched and developed on the cellular genetics and made advances in

the 1960s which is the so-called “green revolution” (Kreipe, 2010). The method, called

“recombinant DNA technology” or “genetic engineering”, allows transferring individual genes

from one organism to another and even between two species which are non-related (WHO,

2013). In short, genetic modification is the process to “excise the desired DNA segment from

one organism” and “spliced into some of the recipient organism’s preexisting DNA” with two

types of enzymes (Kunich, 2001). This technology is used to make organisms obtain useful traits

to overcome limitations of natural diversity and the products are called GMOs. BT corns, which

were modified by BT bacterium to enhance resistance to pests and “Roundup-Ready” soybeans

modified to resistant to the herbicide (Dawkins, 1999) are most famous examples. At the current

time, genetic engineering made more achievement in plants and microorganisms, but it is also

used on various species of animals (Kunich, 2001), such as featherless chicken, pharmaceutical

camels and glow-in-the-dark sheep (Lisa, 2013). At the moment, only GM crops are available for

human consumption.

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Company background

AquaBounty Technologies is one of the biotechnology companies that working on application of

biotechnology to ensure the efficient production of high quality seafood. This company started in

1991under the name A/F Protein, develop of antifreeze protein-based technology under license

from the University of California. In 1996, A/F Protein acquired a license from the University of

Toronto and Memorial University of Newfoundland for GM salmon technology. In addition,

AquaBounty Technologies have more biotechnologies for their products such as gene and

protein identification and analysis, regulation of gene expression, receptor identification and

blocking technologies. This company has been successfully created GM Salmon which is called

AquAdvandtage salmon. Although it is still concerned whether GM Salmon should be released

to market, this company made it more well-known than ever before. The GM Salmon is modified

to develop genetically superior brood stocks to improve growth rates, feed conversion

efficiencies, disease resistance, cold resistance, tolerance to low oxygen levels, and the ability to

digest alternative diets. Although the main purpose for the creation of GM salmon is to content

the market needs and undoubtedly it will bring billions profit to the company, there are potential

risks need to be considered and assessed before it is allowed to be releases into the market.

Background of GM Salmon

GM salmon is the Atlantic salmon genetically modified by a growth hormone-regulation gene

from the Pacific Chinook salmon and a promoter from the ocean pout. It was produced by

AquaBounty Technologies and called AquAdvantage salmon (AquaBounty, 2013).

Usually Atlantic salmon only grows in spring and summer, and needs three years to fully mature.

However, by implanting these genes it is enabled to grow year-round grows to market size in

half the time (Gray, 2010). AquaBounty built a 100-ton/year aquaculture facility in landlocked

highlands in Panama. GM salmon will be grown as sterile, all-female population in fish farms

and cannot escape or reproduce in the wild (AquaBounty). So that the wild salmon can be left in

the ocean safety without threat. Scientists engineered salmon to overexpress growth hormone

successfully in 1989. The company applied for FDA’s (U.S. Food and Drug Administration)

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approval in the US, but has been stuck in regulatory limbo ever since 1995 (Ledford, 2013).

However, according to the recent public news about GM salmon in 1st of February 2013, it has

been told before that the FDA had previously determined GM salmon were safe to eat but not yet

determined for the environment. (Murray, 2013) Then FDA also public a draft about

environmental assessment from AquaBounty Technologies Company and it declared that GM

salmon would not have a significant impact on the US environment. (U.S. Food and Drug

Administration, 2012). Huge group of people are concern about the assessment because they are

still are still not sure if the GM salmon will be whether good or bad for environment and health.

(Murray, 2013) In addition, there is also possibility that GM salmon could also impact on the

certain endangered salmon species positively or negatively. Further information is discussed in

the following parts of the research paper.

Scientific Research

Scientific Research: Positive Opinions

Salmon is the top 3 most consumed seafood in the United States and is enjoyed in both

restaurants and homes (National Fisheries Institute, 2013). Depending on the region salmon is

eaten raw, smoked, grilled, steamed, fried and many more. Salmon is also found to be nutritional

and rich in Omega-3 that is beneficial to human health, especially in areas of cardio related

illnesses and improvement of brain and cognitive abilities (Tassal, 2013). DHA created by

breaking down omega-3 has been known to positively effect brain activity as well as prevent

dementia and control other chronic illnesses. Salmon also has high quantities of vitamin B3,

B12, D and protein. Salmon is a nutrition that should be enjoyed by everyone. However this isn’t

the case.

The population of salmon has been decreasing since mankind has learned and developed ways to

fish. As technology developed, fisheries were built to produce in-house salmon but it was not

sustainable due to the life cycle of salmon and cost too much to supply salmon at a low cost

(Lackey, 2008). Moreover, salmon was not one of the fastest growing fish. The slight

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modification made to the genes of AquAdvantage allows the salmon to grow faster and bigger on

land facilities.

Towards the end of year 2012, the United States Food & Drugs Administration released its

findings on the issue of genetically modified salmon (Brown, 2013). The FDA announced that

they were not able to identify significant effects of GM salmon on the environment; more over

by approving AquaBounty’s GM Atlantic salmon – AquAdvantage, and imposing no regulations

on labeling the product upon sales it can be seen that FDA sees AquAdvantage just like any

other salmon currently in the market.

According to the report by FDA, the differences between AquAdvantage salmon and original

Atlantic are merely observed and has not regulated the labeling of the GM salmon. Although

some grocery store headquarters are campaigning not to distribute GM salmon to its outlets, the

official administrative body says that not enough differences were observed.

The opposing opinions towards the commercialization of AquAdvantage Salmon are the

unforeseen health and environmental risks. However, these concerns are answered through

FDA’s assessment publication regarding the AquAdvantage Salmon. The main environmental

concern is that the genetically modified salmon will reproduce along with original Atlantic

Salmon and effect the food chain and cycle. To this concern, the FDA answers that the chances

of AquAdvantage Salmon leaving its confined area of farming is very unlikely and the only

likely possibility was the flooding of Panama. Moreover, even if the AquAdvantage Salmon was

able to escape the containment, it will not be able to adapt to the environment conditions and the

chances of survival, dispersal and establishment is significantly reduced. A wide effect on the

environment is unlikely but also introduction of new species is what the nature constantly goes

through.

In the unlikely event of an escape, the AquAdvantage Salmon is expected to inhabit in the same

ecological area as domestic and wild Atlantic Salmon. According to Darwin, it is not the

strongest or the most intelligent that survive, but those who best manage change (O’Neil, 2013).

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If AquAdvantage Salmon was to compete against domestic and wild salmon in the new habitat, it

may be bigger in size but must adapt to the environmental change in order to survive. As the

wild and domestic are adapted to the ecological habitat already with a larger number, the chances

of their survival are greatly advantages compared to AquAdvantage Salmon.

The environmental risk posed by GE organisms is similar to that posed by any introduced

species, and is a function of the fitness of the introduced organism, its interactions with other

organisms, role in ecosystem processes, and potential for dispersal and persistence (Kapuscinski

and Hallerman, 1991). It is also feared that when AquAdvantage Salmon were to be introduced

to the environment, the man made alteration may destroy the environment. However, the world

is going through changes constantly. Natural changes occur in all species from plants to human

body cells and the nature is prone to this adaption. As so, in the case of AquAdvantage Salmon

being introduced to the environment, nature will adapt to its effects.

This further explains the second concern of human health risks upon consumption.

AquAdvantage Salmon include a gene from a species of salmon named ‘Chinook’ which can

grow twice the size of Atlantic salmon in half the time; in all respects its identical to domestic

Atlantic salmon (AquaBounty, 2013). “Future health risks have not been studies enough” says

the opposed, but humans have been adjusting genes of animals for generations. Chicken breasts

that are consumed nowadays is not what chicken breast looked like 20 years ago. Through

development of veterinary medication and concentrated breeding to chicken with abnormally

large breasts have made the product in the market larger and suited to customers’ needs (United

Poultry Concerns, 2003). The same can be said about dogs. Dogs seen nowadays are result of

thousands of cross-breeding and nature changes. Through controlled breeding, humans were able

to extract certain characteristics of different dogs. As the role of dogs changes in the world, the

world has also changed to suit the needs.

Changes in nature are inevitable and have been occurring as long as the world existed.

Introduction of AquAdvantage should be looked at as a positive genetic change to our fisheries

and consumers, but should also be monitored constantly

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Scientific Research: Negative Opinions

While AquAdvantage Salmon optimistically promises to address issues of hunger and fishery

depletion (Clausen, 2012), the environmental and food safety health risk it poses remains

prevalent. These risks listed below may ultimately render the AquAdvantage salmon unfit for

cultivation and human consumption.

Environmental Impact

A real concern widely expressed by many was that AquAdvantage Salmon could adversely

impact the marine ecosystem (Eenennaam, 2011). Described as an ‘invasive species’ (Clausen,

2012), the AquAdvantage Salmon would easily out compete wild salmon for food, habitat and

mates should the AquAdvantage salmon were to ever escape their enclosures into the ocean, thus

resulting in the extinction of the already endangered Atlantic salmon (Devlin et al., 2004). The

National Academy of Sciences (Ocean Conservancy, n.d.) published research suggesting that the

release of just 60 GMO fish would have detrimental effects and could result in the extinction of

wild populations in less than 40 generations.

In a statement by AquaBounty Technologies (Clausen, 2012), the company stated that they

would remain committed in growing the transgenic fish in confined in-land systems, minimizing

any potential for escape into any natural environment. However, there still is not substantial

guarantee these confined systems will remain secure in the event of natural disasters, industrial

accidents or even human sabotage. In addition, should the re-circulated water used in the

fisheries for the genetically modified salmon, be accidently released into the natural

environment, genetically modified fish and eggs could escape causing detrimental effects to the

natural environment. More bothersome was the fact that the scope of the possible environment

damage that could result should the genetically engineered salmon or eggs escape their

confinement is not assessed thoroughly by the New Animal Drug Application process used by

the FDA (Ocean Conservancy, n.d.).

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Escaped genetically salmon will transfer exotic genes into the natural salmon genetic pool is a

confirmed consequence should the genetically engineered salmon or eggs be ever exposed in the

natural environment. Despite the fact that AquaBounty Technologies had assured the FDA and

the public that most of their AquAdvantage Salmon interbreeding in the wild would be inexistent

as the fish will be triploid and unfertile (Fox, 2010), which greatly reduces the environment risks.

However Logar & Pollock (2005; p.18) stated that ‘achieving 100 per cent sterility is next to

impossible’. As such the failure of the confinement system would be detrimentally significant

since infertility of the genetically engineered salmon cannot be fully guaranteed. With the high

possibility of its ability to reorganize ecosystems, it is imperiling to even introduce the

genetically modified salmon into the natural environment (Clausen, 2012).

Food Safety Health Risks

The limited date made public by Aqua Bounty Technologies suggested that their genetically

engineered fish posed food safety as well in addition to environmental concerns identified above.

Akther et al. (2001) explains that the risk and uncertainty is created in a number of ways during

the process of genetic engineering. It is further explained that the way DNA replicates and

transcribes can be destabilized with the unnatural transfer of genetic information and genetic

engineering from genetically engineered salmon to it is natural counterpart. This unnatural

alteration of DNA sequences may have adverse effects on the recipient organism’s cellular

processes. Scientists are therefore prevented from determining the affected regulatory functions

due to the uncertainty of the techniques used for inserting DNA (Akther et al., 2001)

In the case of AquAdvantage’s salmon, FDA’s comparative assessment between genetically

engineered salmon and its natural counterpart revealed substantial nutritional differences in their

chemical compositions. It was discovered that the 6 chemicals found in the genetically

engineered salmon had 10% more concentration than its natural counterpart. The 6 chemicals

were namely, folic acid, niacin, vitamin B6, magnesium, phosphorus and zinc (Ocean

Conservancy.org, n.d). This finding indicated the difference in their potential food qualities

between the 2 kinds of fish. It was also found that the omega 3 / omega 6 ratio was also 12%

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lesser in genetically engineered salmon than its natural counterpart (Ocean Conservancy.org,

n.d), a disappointing difference for seafood consumers who are looking to maximize omega 3

levels in their routine dietary intake.

A frightening food safety allegation was the suggestion that the genetically engineered salmon

by Aqua Bounty Technologies had a 40% composition of IGF-1. NutritionFacts.org (2012)

defines IGF-1 as a natural growth hormone that is instrumental in the normal growth during

one’s childhood but in adulthood, it may lead to the promotion of abnormal growth which links

to high probability of development of prostate, breast and colon cancers in adult humans. The

hormone IGF-1 may inflict more problems in one’s life but this speculation has not yet been

observed, such as increased risk of cancer. However despite this, the FDA still inexplicable

considers the genetically engineered salmon safe, additionally neglecting the need to further

investigate the causes of the chemical inequalities of the existence of others.

Regulations in Europe

In the world, the European Unionion possibly is the most stern and rigid GMO regulation. All

biotech food is considered as “Artificially- New Food”. This recent Genetic modified organism’s

(crops, animal and insect ) are evaluated by the European Food Safety Authority(EFSA). The

EFSA provides and assess scientific advice for the risk manager on any possible risk of Genetic

Modified Organism (GMO), Genetic Modified Animal (GMA) and Animal Health and

Welfare(AHAW) for human and environment. The risk management issues that they are concern

of are labeling, traceability, socioeconomics and ethical issues. However, they do not consider

the societal, economic or political concern. Such concerns and determine whether the product

can be placed on the EU market are the role of risk manager (European Commission and the

Member states).

First of all, EFSA will draft a proposal for either granting or refusing the authorization from the

applicants. Followed by, Section in GM Food and Feed of the Standing Committee on the Food

Chain and Animal Health will assess the proposal from EFSA, if proposal is approved it will be

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adopted by Council of Agricultural Minister or European Commission. While once in the

Environment Council 2008 (Council of European Union , 2008), it will take three months to

know the result whether is against or for the proposal. If proposal is rejected, it will pass back to

EC to adopt. If the scientific evaluation is approved, in order to protect the public and animal,

risk management decision should be undergo via Community Procedure before GMO food be

placed on the market with the Regulation (EC) No 178/2002.

In August 2012, the EU has authorized 48 GMOs. Majority of the GMOs are import for feeding

animal and food processing. Currently, MON810- corn (GMO Compass, 2008) by Monstanto’s

Company and Potato (Amflora) (Reuters- Michael Hogan, 2012) are the only two GMO food

crops that approved by EU to be grown in Germany, Czech Republic and Sweden.

Nonetheless, up to now, none of the genetic modified animal has been approved; nor any

application being adopted in EU. However, the EU commission has requested the EFSA to

develop comprehensive risk assessment (food and feed safety) guidelines for the future use if

there are possible future applicants submit the specific issues to ESFA.”

Acting on the request by EU, EFSA has de EFSA has developed two separate guidance

documents for GMO Animal (Salmon) which mention below:

1. January 2012- Food, Feed and animal welfare risk assessment (ESFA, 2012)

Seek to set up appropriate way to compare GM animals and derived

food and ffed with respective comparators

2. May 2013- Environmental risk assessment of GM animals

Guideline to assess potential effects of GM animal on human and

animal health , environmental, rationales for date requirement.

Furthermore, EU authorization system aims to ensure the safety of authorized GMOs while

establishing an internal market for those products. Three pieces of legislation which are

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Directive 2001/18/EC on the environmental release of GMOs (Guidance on the

environmental risk assessment of genetically modified , 2013)

Regulation (EC) No 1829/2003 on GM food and feed

Regulation (EC) No 1830/2003 provides rules on the traceability and labeling of GMOs

and the traceability of food and feed produced from GMOs.

(EFSA, 2013)

Undeniably, although regulations have been set up but the reasons for declaring or banning of

GMOs in Europe or even other countries appear to be diverse. These reasons can be varied from

agriculture justifications related to difficulties of assuring co-existence to economic and politic

motivations such as meeting the demand of GM-free markets. Furthermore, public concern, civil

society and the uncertainty risk if GMO animal is authorized.

One of the obvious reasons is FDA is the only tester and the only corporation approving that

GMO salmon is safe to be consumed in US. The European Union members and the other 64

countries significantly ban or prohibit the cultivation and sale of the genetically modified

organism. As you can see a majority of the countries do not approve any of the GMO salmon to

be commercialized. Since this is only a one-sided approval nobody believes that it is fully safe to

be put on sale to the global market. Therefore from these 2 corporations, the world leans towards

the unapproved GMO salmon at the moment as they do not think FDA has enough results to

show that it is safe enough to be consumed at this point of time.

Public Concerns

“We don’t have any monster pigs in Europe, or monster cows, and there’s no need for such a

salmon,” said Geir Isaksen, the chief executive at big Norwegian fish farmer Cermaq.” (Casandra

Profita, 2013)

According to recent news reported by OBP.ORG, European Commission survey found 77

percent of Europeans oppose GM food of any kind (Casandra Profita, 2013). In 2010, Euro

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barometer surveys has resulted 66 per cent of European citizens were concerned about GMO

food (EUROBAROMETER 354, 2010).While in 2008,there is 84 per cent of EU citizens were

most concerned that they do not know enough about the safety effect of consuming cloned

animals for food and health issues in long term (Eurobarometer 238, 2008)

Based on the above qualitative and quantitative statements, European has dramatically voiced

out the un-needed and reluctant consumption of any future GMO salmon or any kind of GMO

animal. In addition, public engagement plays a vital part on legislative process due to the human

rights, legitimate interest, need of justice and equity. If FDA & ESFA has a better “Transparency”

and also more and reliable tests for a longer period of time (to know whether or not there are

other side effects) then will it aid in terms of educating the public for GMO. This will then

enable the consumers to consider again the need of having an alternate food production as well

as future consumption of GMO. Hence, ensuring the true democratic participation is very

important before EU begins to any process on considering GMO salmon to be approval.

Civil society concerns

The Civil Society groups are known as the “third parties/sector” of the society, where it is more

of groups of non-governmental organizations and institutes to voice out the interests and wills of

civilians.

“On 27th January 2012 civil society groups wrote to several EU Commissioners to demand that

“the drafting of technical guidance stops until a broad assessment with all stakeholders has taken

place to decide whether or not food products derived from GM animals are wanted within the

European Union.” (Friends of the Earth Europe, 2012)

This does not only concern the public but also many different groups that has gathered and

considered the following of the GMO food products in the EU. These civil society groups have

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further insisted on having a wider range of assessing the GMO with all the organization that can

test and decide for the GMO products to be wanted or not.

Marks & Spencer:

“Regarding GM animals...we are not active in this space at all and have no plans

to be.”

Morrisons:

“We have absolutely no plans to sell meat (or other products) from GM animals.”

Tesco:

“We do not stock, and have no plans to sell GM animals or derivatives of GM

animals in our stores.”

(Friends of the Earth Europe, 2012)

Figure 1 (Friends of the Earth Europe, 2012)

Based on above statement and Figures 1, have clearly shown the strong against of GMO salmon.

Although GMO salmon can be bought in cheaper price by the supermarket’s company and sell it

in cheaper price. Consumer able to buy it with an affordable price compare to wilds-salmon. It

could also help in drive economy and decrease tax in Europe. However, the win-win situation

still not able to back down the vigorous oppose from the communities due to their culture and

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conservative mindset; and popular supermarket also no concern of a need for GMO food

products at all

Thus, in these different perspectives that the EU leans towards the unapproved GMO salmon at

the moment as they do not think FDA has enough results to show that it is safe enough to be

consumed at this point of time.

The US Regulatory Framework of Biotechnology

The U.S. and the EU have very different approaches of the regulations and applications of

Genetically Modified (GM) food. The EU has known to be strict to the regulations of GM food

mainly due to the major public concerns to their health safety, whereas the majority of the U.S.

agricultural community is more supportive to the applications of GM technology though the U.S.

general public mostly stays neutral towards it (Ganiere, Chern, & David, 2006). According to

ISAAA Brief 44-2012: the US continued to be the dominant producer of GM crops in the world

at 69.5 million hectares, of about 90% of all GM crops in 2012 (International Service for the

Acquisition of Agri-biotech Applications [ISAAA], 2012) The differed attitudes between these

two regions induced dispute on the concerns of the approval of GM food by regulatory bodies, as

well as correspondent regulations, and hence the government officials formulated their own

legislation standards and legislative processes.

United States Federal Government had two different concerns to its legislation framework to

Genetically Modified Organisms (GMOs): 1. if the government has adequate authority to

regulate the GMOs because a distinct new form of agricultural technology requires respective

new legislation. 2. Whether regulations should govern the GMOs’ production process rather than

the GMO products. Hence, the government organizations spited into two sides by their

difference supporting views. The first were bureaucracies promoting the business potential of

GMOs products and just regulate the actual products: the White House, by the US Department of

Agriculture (USDA), the Office of Science and Technology Policy (OSTP), as well as the Food

and Drug Agency (FDA). The second was the Environmental Protection Agency (EPA), which

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seeks for the development of progress regulation for GMOs without requesting for new

legislation (Lynch & Vogel, 2001).

In 1984, the Cabinet Council on Economic Affairs was in charge of the regulations of

biotechnology, and the working group is established by the Biotechnology Science Coordinating

Committee which consists of EPA, USDA, and FDA as the three major agencies for regulating

the biotechnology. This working group issued Coordinated Framework for the Regulation of

Biotechnology, under which, the FDA is regulating the biotech-medicine; the USDA is in charge

of GM plants, and the EPA is responsible for pesticide plants and GM microbial pesticides;

which became the basis for regulatory policy in the US (Lynch & Vogel, 2001).

US Regulative process of GM Salmon

Under the Coordinated Framework for the Regulation of Biotechnology as mentioned above, the

FDA regulates GM animals as new animal drugs under the Federal Food, Drug, and Cosmetic

Act (FFDCA) because there is no specific legislation directly addressing animal breeding in the

US yet. The reason that the FDA regulates GM animal as “new animal drug” is because, as

stated in the Section 512 of the FFDCA, GMO is “an article intended to alter the structure or

function” of the animal (U.S. Food and Drugs Administration, 2013). Any new animal drugs

(GM animals as food are required to go through the whole approval process before they are able

to be introduced into the market. For any new drug applications, the sponsor is self-responsible

for the cost and the research/studies required obtaining respective data required for the approval

process (U.S. Food and Drug Administration, 2013). For the GM animals, the Veterinary

Medicine Advisory Committee (VMAC) is to be held by FDA after it completes its regulatory

review of each relevant data in order to present its findings and receive comments both from the

VMAC and the public. And currently, the FDA is the main body responsible for regulating and

approving the GM food in the U.S under the Food, Drug, and Cosmetic Act of 1992 (FDCA).

The FDA is also part of the Codex ad hoc Intergovernmental Task Force on Foods Derived from

Biotechnology and its Working Group that established the newly applied guideline for food

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safety assessment of GM animals such as GM (The American Society of International Law,

1999).

FDA Approval Process:

-

Any new animal drug, for the case here is the GM Salmon, is required to go through the whole

FDA approval process of a set of complex stages for new animal drug before it can be introduced

to the market. Before it can get the approval from FDA approval, the product is required to be

proved as valid and safe. A New Animal Drug Application (NADA) is required to be presented

by the company, AquaBounty for the case of GM Salmon here, to FDA including relevant

scientific data of any possible side effects or adverse health risks the GM salmon may induce.

The company must present that it is capable of producing the product at consistent level and the

ingredients are from good sources, which follows good manufacturing practices for the

production. If the drug product is for animal as human consumption, residues in food product

from the animal are regulated to be proven no negative impact for human health. Please refer to

the Approval Steps for New Animal Drug (e.g. GM Salmon) as shown below:

Step 1: Product Identification

Step 2: Molecular Characterization of the Construct

Step 3: Molecular Characterization of the GE Animal Lineage

Step 4: Phenotypic Characterization of GE Animal

Step 5: Genotypic and Phenotypic Durability Assessment

Step 6: The Food/Feed Safety and Environmental Safety Assessments

(U.S. Food and Drugs Administration, 2013)

As declared in the FDA official website, FDA has already released a draft environmental

assessment (EA) in regards of the its review of the use of AquAdvantage Salmon (a GM Salmon

produced by AquaBounty ) for public comment in 2012. The draft assessment implicates that the

application of the GM salmon under the specific conditions as proposed, would have no

significant impact on the U.S. environment. This draft EA is part of the final steps in FDA’s

evaluation of the AquAdvantage Salmon, however it does not equal to the final approval of the

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use of GM Salmon. The National Environmental Policy Act of 1969 (NEPA) requires FDA and

other federal agencies to undergo such evaluations before any a major Federal action is taken. If

the GM Salmon passes the final stage and approved by the Federal agency, it will be the first

GM Animal approved for human consumption (U.S. Food and Drug Administration, 2012).

The release of the EA actually aroused great public concerns and worries. A surveys shown that

many (66%) of the US citizens are not opposing to GM crops (Ganiere, Chern, & David, 2006),

while the reality shows that the acceptance level for the GM Salmon is much lower than those

for GM plant products, only minority shows their acceptance for GM animals into the market

and even some federal agencies like the EPA and U.S. Fish & Wildlife Service are still bearing

the environmental concerns. The US public and Non-Government Organizations (NGOs) are so

reluctant to accept and even strongly opposing the approval of GM Salmon, and out of such

pressure arisen from the general public, the FDA even made an extension of 60 days for the

comment period for the EA and preliminary Finding of No Significant Impact (FONSI) of the

application for first GM Salmon (U.S. Food and Drugs Administration, 2013). According to the

Food and Drug Policy Forum of The Food and Drug Law Institute (FDLI), the general public

concerns are mainly come from the following reasons: fear of the risk for health, concerns for

environmental impacts, but more about the limitations of the regulations and FDA assessment

which will be further discussed in the next section of the paper (The Food and Drug Law

Institute, 2013).

Questioning the Credibility of the FDA Assessment

Conflict of interest:

As stated in the EA by the FDA, the FDA did not implement any independent research for the

GM Salmon to get the data for the environmental or the health assessment; instead, it obtained

the information and data package mainly from the AquaBounty Technologies, Inc. This led to

the great concern of the credibility of the FDA assessment, because the AquaBounty

Technologies might only submit the data which is in favor of their own interest and hide the

unfavorable information which may negative affect the approval of their AquaAdvantage

Salmon.

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Limited Consultation with Independent Experts:

Failure of meaningful consult with other agencies has contributed to weaknesses in FDA. U.S

Fish Wildlife Service USFWS scientist is one of the consultations that revealed being left out of

FDA’s assessment. The rise of strong rebuked from USFWS Conservation Genetics Community

of Practice has been calling it “Overly simplistic” and “there are several unknown and

uncertainties” over FDA. The reasons are FDA’s science failed to ask and answer many

fundamental questions, lack of studies on risk assessment and also missing crucial pieces on

environment assessment data. Furthermore, the foods safety information is too weak to be served

as basis for FDA’s approval for the first world biotech food animal. In addition, the role of

National Marine Fisheries Services has also been limited during the risk assessment process, in

spite of their expertise to the subject-matters of fisheries and environment.

Recommendations

As mentioned above, GM food has become a topic we have to consider. It has many advantages

but may also lead to potential risks. Comprehensive legislation must be created as soon as

possible to cope with the problems would arise. The authority should continue to improve the

legal framework concerning GM food.

Credible Assessment Process The FDA’s report about GM salmon almost depended on the non-peer-reviewed studies

submitted by AquaBounty. For example, the analysis of IGF-1 levels of GM salmon use the data

from an AquaBounty study in 2004 (Food and Drug Administration Center for Veterinary

Medicine, 2010), and the analysis of the nutrition of GM salmon use the data provided also by

AquaBounty in 2003, which both were paid for or performed by this company. There is evident

potential that the presented data can be deficient while unfavorable data is not presented. As a

result, the process would lead to biased result.

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To prevent any conflict of interest, a proper risk assessment should be done with data obtained

from independent primary research, conducted by scientists do not have financial relationships

with the company. Authority could organize the professionals to monitor data collection to

ensure the authenticity. In addition, the whole data must be forced to present no matter if it is

beneficial to the company. Only through this, the FDA can assess the GM salmon convincingly.

Comprehensive Pilot-Test Regulation As GM food is still at the developing stage, animal testing and human testing is unavoidable. So

far, scientists have done experiments focus on animals such as the study that observed how rats

were affected by eating GM potatoes in 1998 (Fedoroff, 2006). However, such tests can be

limited to prove if GM food is safe for human beings. According to Dr. Carmen from the

Institute of Health and Environmental Research, Inc., the testing done now is “woefully

inadequate” (Roseboro, 2009). Long-term safety tested by agencies independent of GM interests

is needed.

Very little testing has been done on the influence of human ingesting and applying GM food,

which is necessary but can be risky at the same time. Therefore, specific regulation about body

testing of GM food should be built to make sure such trials are under control and following the

medical ethics. Volunteers must have the right to know the detailed information, including the

objectives, process and the potential risks of GM food.

Standard Regulations on Production Process According to WHO (2013), there are many issues to the environment during the production

process. The modified genes may escape and be introduced into wild populations, which means

the GMO crossbreeds with wild organism. In addition, as GMO has better resistance to bad

conditions, it is much more competitive compared to normal organisms and poses a threat due to

the limited resource. Thus, GMO becomes a detrimental risk to biodiversity.

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In the case of GM salmon, a study from Canadian scientists shows that it can crossbreed with the

brown trout, a closely related species of the Atlantic salmon (Oke et al., 2013). Researchers

found they can mate and have offspring successfully. The hybrids are outcompeting both wild

salmon and GM salmon (Morelle, 2013). Although AquaBounty claimed the salmon produced

are mostly sterile female and kept in tanks on land, there is still change of the escape of fertile

fish into the wild, and risk still need to be considered (EFSA,2013).

To prevent any possible risks, policy is needed to control the producing process to protect

environment and biodiversity if the GM Salmon is approved into the production. The safety of

fish farm and the method of gene modifying must be monitored by authority to make sure

conventional aquaculture not be threatened by GMO contamination.

Mandatory Labeling While the GM salmon is launched, labeling is important to take into consideration. The objective

of GMO labeling is to give consumers the right to know and the freedom of choice between GM

and traditional product (GMO Compass, 2007). In the EU, it is mandatory to label products

contain or derived from GMO since 1997 (European Commission, 2013). However, in the USA,

the FDA never forced for labeling although GM products were approved for consumption as

early as 1995 (Cleveland, 2013). It makes most of Americans worried about GM food and a New

York Times poll shows 93% respondents support for labeling (Kopicki, 2013).

Consumers’ right to know and choose should also be well respected before the GM salmon is

launched to the market: regulations on mandatory labeling for GM food should be required. GM

food should be labeled to reassure consumers. As GM salmon is the first GM animal for human

consumption, it should have specific labeling. According to the survey done by a Consumers

Union, 95% of respondents thought GM animal should have unique label (Nordqvist, 2010).

Policy should emphasize this request to protect people’s right to know and freedom to choose.

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Specific & Effective Regulations on Imports & Exports With the economy development and the population growth, food demand is also increasing.

Nowadays, lack of food has become a problem people have to face. Although people have

different opinions and countries have different legislation towards GM food, undoubtedly it is an

efficient solution to. Many scientists holds that GM crops can provide higher yields and better

nutrition, which is good for small-scale and subsistence farmers in developing countries (Berman

et al., 2013). By 2050, the population over the world will reach 9 billion. Proponents of GM food

believe it helps to avoid starvation because protecting against pests, weeds and drought can still

lead to boost harvests even in bad conditions (Olster, 2013).

Obviously, for countries with large population like China and the US, import GM food is the

certain trend due to the fast growth speed and the adaptability to the any condition. On the hand,

poor countries like Africa are also in need of such supply to solve the hunger issue. However, as

import and export of GM food is not as simple as normal food, detailed regulation must be

created to apply for such cases. As the biggest market of salmon is the US and Europe, these two

areas should establish more specific and effective legislation on GM food imports and exports.

Conclusion

AquAdvantage should not be restricted from commercializing; however, the process from

introduction to sales must be carefully thought out and controlled by respective organizations.

Introduction of AquAdvantage Salmon will allow farmers to produce more efficiently and

provide customers with quality salmon at a more reasonable price. The benefits of GM salmon

are also well known. However, it is still not sure what effect the genetic mutation may affect

human and the environment; especially when the genetic change is artificial and does not take

place naturally. For this reason, sales of AquAdvante Salmon should be well-controlled, effects

constantly monitored, and information should be transparent to customers. Moreover, the

consumers must be given the choice to choose what they eat. It is vital that products sold are

labeled to let the buyer know whether the salmon they are about to purchase is wild or

genetically modified. Consequently, laws must also be made so that restaurants and other outlets

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are forced to inform their customers of the origin of ingredients. In order to ensure that the final

product is also legitimate, appropriate pricing must be used upon introduction and strict control

to ensure that minimum level of mis-labeled products.

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