1.0 The FDA : The Cognitive Authority of Science
The Food and Drug Agency (FDA) is the central Federal body in the United States
responsible for regulating the safety of the commercial food supply. Its legal authority stems from
the Federal Food Drug and Cosmetic Act (FFDCA), which was written in 19381. However,
science and technology, and especially transgenic technology, have advanced far beyond a point
that was foreseen was the FFDCA was originally written, while regulatory policy has failed to
advance at the same pace. The result is that transgenic food does not have its own policy niche in
the United States: instead, it is regulated as being equivalent to its conventional counterpart due to
a product based philosophy. The advent of transgenic fish poses new and unique challenges to the
current regulatory framework, as “there are no federal laws that directly regulate the use or
release of GM fish or other transgenic animals2”.
The American guidelines for regulating the biotechnology industry first surfaced in 1986,
and were created by the Office of Science and Technology, with the help of a working group3.
The primary focus of this group was to create a regulatory structure that found a balance between
health and environmental safety while “maintaining sufficient regulatory flexibility to avoid
impeding the growth of an infant industry4”. This working group came up with the historic
decision that has dominated this regulatory field until now: that no new laws are required for the
regulation of biotechnology. The guidelines that form the Coordinated Framework for
Biotechnology also emphasize that genetically engineered food should be regulated by the
product, not by the process, and generally should be evaluated on the basis of risk. Most
importantly, the coordinated framework served to close the lid on further discussion about
biotechnology. Biotechnology “ceased to be a matter for broad participatory politics and instead
became an object of bureaucratic decision making under the guidance of technical
experts”(Jassanoff, 52).
The dominance of scientific expertise over policy came from the report produced by the
NRC in 1989 that said that commercial biotechnology posed no special threat to human health or
the environment. In 1992 the Substantial Equivalence doctrine was used in the FDA’s Statement
1
Wood, Susan. Increasing the Transparancy of the FDA: the impact of the FDA
Amendments act of 2007.
2
Marden, Emily. Longstaff, Holly. Levy, Ed. The Policy Context of Public Consultation:
A Consideration of Transgenic Salmon. (The Integrated Assessment Journal. 2006). 78
3
Zeichner, Lauren. Product vs. Process: Two Labeling Regimes for Genetically
Engineered Foods and How They Relate to Consumer Preference. (Environs,2004) 482.
4
Coordinated Framework for Biotechnology
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of Policy with regards “Foods derived from New Plant Varieties”(FDA statement of policy). The
substantial equivalence doctrine posits that if GE crop have similar health and nutritional
characteristics as its conventional counterpart it should be considered equally safe and will not
require special scrutiny when being regulated. By applying substantial equivalence as a
regulatory framework, the safety of the protein is assumed as well as the absence of any harmful
side effects. This results in GE foods being exempt from any special labeling, which creates
further distance between the policy makers approving the products and the consumers buying
them.
Politically insolated regulatory bodies such as the FDA exist because there is a
requirement in liberal democracies for highly specialized and esoteric knowledge due to the
complexity of public decisions. In the case biotechnology, there are two obvious reasons for
letting scientific expertise dominated the way policy is created (or in this case, not). First,
understanding biotechnology requires highly specialized, esoteric knowledge. To subject the
evaluation of this process to those who do not posses this knowledge would either result in
regulatory paralysis or a disregard for safety. Therefore to avoid this the authority to make
decisions is granted to those who understand the technology. Second, it is much simpler to define
decisions as technical rather then political. “Technical decisions are made by defining objectives,
considering available knowledge, and analyzing the most effective ways of reaching these
objectives. Debate over technical alternatives need not weigh conflicting interests, but only the
relative effectiveness of various approaches for resolving an immediate problem” (Dorothy
Nelkin). By using “science” as a policy tool, decisions can be made quickly and effectively.
The state attends to the opinions of science and gives it an authoritative voice. This
authority is reaffirmed by requiring regulation to be based on scientific findings, and by
promoting these findings as objective facts (Turner, 124). This is how truth and authority become
one and the same in science and technology policy. Only experts can understand why a fact is the
truth, while the rest of the population has to accept it as true without understanding the grounds
behind it. With genetic engineering, the public can be told the basic principles of the process but
will not be trained in a way to fully understand what it means. Therefore, the public must trust the
knowledge of the experts, as it is the experts who wield the cognitive authority of science.
“Expertise is a kind of possession of knowledge that is testified to be officious and in which the
testimony is widely accepted by the relevant audience” (Turner, 130). This means that the
cognitive authority of science only works if its intended audience accepts it.
2
The FDA and the Salmon
Until now American Biotechnology policy can be characterized as being based on the
idea that GE food is mainly the same as their conventional counterparts. However, until
September 2010 all genetically engineered food to go through the FDA has been plant based crop.
The AquaAdvantage salmon is the first time a genetically engineered animal has been up for
FDA regulation5, and therefore its regulation will set a precedent for the way other genetically
modified animals are regulated. The FDA had two obvious routes: the first being to fall back on
the substantial equivalence formula, and the second was to make a new novel policy. The FDA
chose neither, and instead decided to regulate the salmon as a veterinary drug. “To reach this
conclusion, FDA identified the transgenic fish as an article (other than food) intended to affect the
structure or function of the body of man or other animals…this regulation contortion was taken in
order to subject the novel fish to the most stringent regulatory review available6”i.
The FFDCA definition of a drug is “articles (other than food) intended to affect the
structure or any function of the body of man or other animals”(FDA final guidance for GE
animals). In genetically engineered salmon, the rDNA construct that alters the fish’s composure
provides an opportunity to place it under this definition meaning it falls under the regulatory
procedure of a drug rather then a food. On one hand, this means that the salmon will go through a
more stringent procedure. However, due to FFDCA and the Trades Secrets Act, there is more
confidentiality in the development of drugs then foods, meaning that there is more secrecy in the
approval process.
Fitting transgenic animals into this unusual regulatory framework has raised many
objections from members of a National Research Council committee responsible for investigating
science-based concerns over animal biotechnology, as well as environmental and consumer
advocacy groups7. These parties voiced the concern that when Congress passed the FFDCA’s
New Animal Drug regulations(date), congress did not anticipate that it would be used to evaluate
the unique risks posed by transgenic animals. The New Animal Drug regulations were originally
created to regulate new substances such as antibiotics for livestock or pets, and seems as if it is
being stretched when applied to transgenic salmon8. This raises the concern that the current
5
Up for regulation for human consumption, First GE animal was the GlowFish
Marden et Al. 78
7
Logar, Nathaniel. Pollock, Leslie K. Transgenic fish: is a new policy framework
necessary for a new technology?
8
Taylor, David A.
6
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regulatory framework may not be adequate to deal with the new issues posed by transgenic fish as
well as future genetically engineered animals. The objections over the regulation of this
technology demonstrate the fallibility of using cognitive authority as a basis for political
legitimacy. This flaw is that “expert claims do not permanently or inherently occupy the status of
scientific” (Turner, 142). When issues come up that grant reason to question the legitimacy of
expert claims, the expert claims themselves come under public scrutiny, losing the trust that
granted them legitimacy in the first place.
The expert model of decision-making used by the FDA creates what Steve Fuller has
labeled as “mutually tolerable ignorance”. This means that the public understand very little of the
science they believe, while scientists to not have first hand knowledge of the experiences they
pronounce. The reliance on technical expertise alone becomes problematic when applied to real
life situations, such as the regulation of genetically modified salmon. First, the failure of the FDA
to create new policy means that an item posed for mass human consumption is regulated in the
same way as bovine antibiotics. This has the consequence of the full portfolio of impacts of the
salmon is not being assessed, which creates public backlash. Second, the FDA’s neutrality has
previously been doubted, causing the media and the public to question its decisions, which further
erodes its authority. Lastly, while the FDA is losing its cognitive authority there is no place to
make up for it with meaningful public participation. The controversy around the salmon case
highlights contradiction of the FDA’s place as a politically isolated institution dealing with highly
political issues.
1.1 The Failure of Regulatory Policy to Fully Assess the Salmon
The salmon is being regulated by an agency that does not have authority over the entire
range of issues raised by the salmon, as there are no new laws or regulations that directly address
the products of biotechnology9. When the Coordinated Framework was first developed, one of its
main goals was to “to avoid impeding the growth of an infant industry”. However, with global
revenues of 50 billion USD in 200410, biotechnology is clearly no longer an infant industry.
Therefore it may be time to depart from path dependence and create a new regulatory framework
that takes into account a full portfolio of impacts associated with transgenic foods and specifically
animals.
9
Marden et Al. 77
http://www.economist.com/node/6838715
10
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The current FDA framework for evaluating the AquAdvantage salmon quantifies the
risks of the new product compared to conventional salmon, looks at the new products nutritional
profile and tests it for toxins and allergens. By using the animal drug provision, the salmon
cannot be sold on the market until it has demonstrated that 1) the drug is effective, 2) it is safe for
the target animal, 3) it is safe for humans to consume food derived from the treated animal, 4) it
will not cause undo harm to the environment, 5) It is safe for the user to handle, 6) it is clearly
labeled to communicate noteworthy risks and 7) a summery of the data has been made available
as required by the freedom of information act. (PEW) However, this ignores all the other
potential impacts that this product could have. “Because the approval of GE salmon will set an
important precedent for GE animals intended for human consumption, it is essential to establish
an approval process that assesses the full portfolio of impacts to ensure that such decisions serve
societies best interest.11” From a utilitarian perspective, this form of health assessment is seriously
lacking, as it does not truly weigh the costs and benefits over multiple scales of impact: it ignores
market considerations, environmental impacts, and social concerns.
“The most commonly voiced concern by experts and the public alike is whether FDA,
alone, has the capacity and/or authority to consider environmental, social, and ethical issues that
are not technically in its mandate12”. In a legal sense, the current mandate of the FDA is to ensure
that products are safe and effective. There is no incorporation of broader social and ethical
concerns, which makes sense given the FDA’s original role. However, now that the FDA’s role
has expanded to the approval of highly controversial technology, it is stuck in a position where it
lacks the legal jurisdiction and political power to deal relevant with social and ethical concerns
that fall outside of its mandate.13 Furthermore, The FDA is performing too narrow an analysis of
the product – as a veterinary drug, it is only examining the substance produced by the genetic
modification, that is one particular protein. The studies that AquaBounty submitted to the FDA
11 Martin D. Smith, Frank Asche, Atle G. Guttormsen, and Jonathan B. Wiener.
Genetically Modified Salmon and Full Impact Assessment (Science, 2010) 1052.
12
Longstaff
Marchant, Gary. Meyer, Ann. Scanlon, Megan. Integrating Social and Ethical
Concerns Into Regulatory Decision-Making for Emerging Technologies.
(SCI&TECH.2010) 354.
13
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“…addressed aspects of food safety, animal health, and product efficacy. The absence of longterm environmental and social impacts in the list of attributes addressed is notable”14.
With these considerations in mind, the FDA was made to only look at technical decisions
for a reason. This reason was to keep it isolated from the political process and to ensure that
decisions where not influenced by any consideration other then safety. However, the FDA has not
always acted in a neutral way, demonstrating the difficulties of trying to separate science from
politics.
1.2 The Problematic Politicization of the FDA
The FDA faces a problem playing the role a politically isolated institution while making
decisions that are politically charged. The agency performs risk assessment using science-based
information and therefore gains its legitimacy from the fact that this information is “…unsullied
by political or social considerations15”. However, when examining the case of the FDA dealings
with Plan B, the emergency contraceptive pill, as well as problems with financial conflict of
interests in its advisory panels, it becomes obvious that the FDA is not as politically isolated as it
would like to be.
In 2006, the emergency contraceptive pill was finally approved for over the counter sales,
after three years of delay despite being voted in by the FDA council. This decision was only made
after members of congress threatened to block the confirmation of the next FDA commissioner.
However, under the Bush administration this medication was only available to women over the
age of eighteen. In 2009 there was a court ruling to allow seventeen year old girls over the
counter access to an emergency contraceptive pill The judge at the ruling, Edward R. Korman,
stated that the FDA repeatedly delayed issuing a decision on this drug for political reasons16.
“Under U.S. law, the FDA has the responsibility to approve drugs for sale once their efficacy and
safety have been demonstrated. Until now, approval has been based on scientific evidence from
well-designed clinical trials with adequate power to establish efficacy and rule out toxicity at
some reasonable level of confidence. Political considerations have wisely been kept out of the
decision-making process. Although the FDA is frequently criticized by politicians and others for
14
Lombardo, Paul. Bostram, Ann. Swimming Upstream: Regulating Genetically
Modified Salmon (Springer Science, 2008). 332.
15
Meghani, Zahra. The US Food and Drug Administration, Normativity of Risk
Assessment, GMOs, and American Democracy. (Agric Environ Ethics, 2009) 128.
16
http://www.npr.org/templates/story/story.php?storyId=102294234
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being either too lenient or too tough (depending on one's political or commercial perspective),
the integrity of the process has seldom been questioned.17” (don’t want whole quote but general
idea)
An integral part of FDA approvals is the decision making process of advisory
committees. Therefore the impartiality and thoroughness of these committees is a principal factor
in the soundness of a final decision. These committees are formed when the FDA seeks outside
expert advice, and members discuss different questions posed by the FDA and vote on
recommendations. However, members of these committees often have financial conflicts of
interest with the product they are discussing, which raises questions about the objectivity of the
FDA18. These conflicts of interest become such a problem that in 2007 the FDA created
amendments to bring more transparency to FDA regulations. While these amendments help to fix
the problem, much of the damage has already been done as the issue itself has tarnished the
FDA’s image as an impartial regulatory body.
1.3 The Lack of Public Participation in FDA Decisions
The extent to which regulatory practices are “transparent, clear, and open to public
participation”19 will determine the integrity of the regulatory system and consequently the its
legitimacy in the eyes of the public. By applying the animal drug process to regulate the salmon,
much of the information concerning the application remains undisclosed to protect intellectual
property.
The FDA provides a public-comment opportunity in conjunction with the Advisory Panel
meeting for each modified animal it reviews, but this input is severely limited for two main
reasons. First, the agency can issue its findings without providing all the underlying data, which
requires consent from the company20. This is because the FFDCA and Trade Secrets act prevents
the FDA from sharing information with the public before a decision is made on an application,
limiting the FDA’s control of the transparency of the regulatory process. This is problematic as it
means the public does not have reliable access to information concerning the specific transgenic
animals under consideration. Second, the FDA “carefully define the terms of debate by stating
17
Davidoff, Frank. Sex, Politics and Morality at the FDA: Reflections on the Plan B
Decision. (The Hastings Center, 2006).
18
Wood, Susan. 2
19
PEW Initiative report on Biotechnology
20
Taylor, David A. Genetically Engineered Salmon on the FDA’s Table. (Environmental
Health Perspectives, 2010)
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their mandate was to hear issues raised by scientific risk assessment and not non-technical
issues21”. By blocking out any non-technical issues, the FDA lack data on social values, norms
and preferences when making the approval decision. The opportunity for meaningful public
commentary is lost as the public is left to rely on other sources of information, including media
and the FDA does not take into account the values of society22.
An example of the FDA failure to address the publics concerns is Stauber v. Shalala
Case. In this case, The FDA’s position that recombinant BST in milk did not require labeling was
challenged on the grounds that there was a consumer demand for labeling23. The court found that
milk consumers failed to prove that milk gained from rBST-treated cows differed in any
noticeable way from "ordinary" milk. The FDA was legally required to ensure that products are
not misbranded and consumer demand alone could not require the FDA to forgo this duty.
Another more recent example is the FDA’s decision to approve the marketing of milk and meat
from cloned animals. This approval provoked thousands of comments from the public raising
ethical concerns. The FDA in turn refused to engage in the issue, using the argument that it is not
the agency’s responsibility to deal with non-technical issues24. The disconnect between consumer
demands and FDA actions can be seen as a contributing factor to the decline in American support
for transgenic organisms. “Americans’ support for transgenic organisms has eroded down to 61%
from 78% since 1997, as the controversy over genetic engineering has become more
prominent.25”
FDA Conclusions
The FDA original purpose was to be an agency that acted as a guardian between the
public and technical innovations, and that approved different products based on safety and
effectiveness. However, two parallel forces have been at work, which have had the dual
consequence of eroding the FDA’s legitimacy. First, technologies are becoming more complex,
and consequently the impacts of there approval are more complex and diverse. Second, the FDA
faces pressures from all sides, making it vulnerable to all sorts of criticisms. There is obvious
pressure from industry, and free market advocates, who believe that the economy, medicine, and
21
Marden et al. 91
Logar, Nathaniel. Pollock, Leslie K. Transgenic fish: is a new policy framework
necessary for a new technology?
23
Gilhooley, Margeret. Reexamining the Labeling for Biotechnology in Foods: The
Species Connection. 1102
24
Marchant et al. 347
25
Logar, Nathaniel. et al.
22
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public interest would fare better with very little regulation26. However, congress also exerts
opposing pressure, often pushing the FDA for more stringent regulation. Therefore the FDA is
under constant barrage of criticism for being either “too fast” or “too slow”, showing the political
difficulty of balancing on the line between safety and speed of regulations. Finally, the FDA has
to be accountable to the population at large, is “under constant, detailed, and intensive scrutiny by
the media and, consequently, the public.27” The FDA is left in a very precarious position: it is a
making science based decisions on highly controversial technology while being publically
scrutinized.
As demonstrated, the FDA is stuck. As a regulatory agency it gains its legitimacy from
focusing on purely scientific concerns, but it is losing its legitimacy because it does not address
social and ethical concerns. For decisions to be accepted by the public, it is necessary to ensure
public credibility and confidence in the FDA’s actions. However, as I have shown, the FDA is
suffering from a loss of legitimacy that is especially apparent in relation to the salmon case. To
figure out how to solve this puzzle, the problem must be unpacked. First, in a legal sense,
congress has only charged the FDA with ensuring that products are “safe” and
“effective”(Marchant et al). This means that not only are social and ethical concerns out of the
agencies stated mission, but the FDA actually lacks the legal jurisdiction to respond to none
scientific concerns. Furthermore, social and ethical issues are often intangible, difficult to define,
and shift over time. They do not lend themselves well to the quantitative analysis that is used for
safety determinations by regulatory agencies (Marchant et al.). Lastly, it simply does not make
sense to make regulatory agencies the “arbitrators” of morality as it is not their area of expertise.
While the scientists who staff the FDA are experts in the fields they study, the do not have ethical
or moral expertise (Marchant, Miah). However, even with all these caveats of incorporating
ethical concerns into a risk analysis, none scientific concerns in relation to the salmon cannot be
simply ignored. It is the consumer that makes the final decision about a novel product, and
therefore the consumer that will decide if a product will sink or swim. If the concerns related to
the salmon are not properly addressed the opportunity to reap the potential benefits from this
technology, as well as future technologies like it, will be severely hampered.
26
Jeffrey M. Drazen, M.D., Michael F. Greene, M.D., and Alastair J.J. Wood, M.D.)
Frank Davidoff, 7.
27
Davidoff, Frank. 52
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