Genetically Modified Foods: The United States v. the
European Union
Ann Berridge
Professor David Friedman
Legal Issues of
the 21st Century
Final Paper
May 10,
2004
Introduction
Imagine a world where people are suffering from starvation, it’s not
very difficult. The starving people are offered food from another wealthier
country. This food is healthy, consumed by many people from the country where
the food is grown, but has not been tested and researched to be considered safe
for human consumption. Due to the unknown facts about the safety of the food the
starving people refuse the offer and choose to continue to starve. The situation
described above illustrates what happened in Southern Africa in 2002. Southern
Africa was devastated by famine and the United States offered aid in the form of
genetically modified
[1] grains.
Several countries requested that the grain be milled so that it could not
cross-pollinate with the grains grown locally while Zambians declared that the
grain was “poison” and refused to accept the aid. Although the
safety of genetically modified foods is one reason the Zambians refused to
accept aid, there is an even more formidable reason. Half of South
Africa’s agricultural exports are sold on the European markets. By
accepting genetically modified grains they may possibly be contaminating their
crops which would destroy their trade relations with
Europe.
[2] Additionally, the Southern
African countries fear that the acceptance of the United States aid would leave
them dependent on the biotechnology companies that developed the
grain.
[3] As illustrated by the
passage above, the United States and the European Union are engaged in a global
“food fight.” The two trade powers are at odds due to their very
different stances regarding genetically modified foods. The United States
maintains a liberal position while the European Union maintains a conservative
position. The United States is very product focused. Their concern is with
advancing the science of genetic modification. In order to promote the swift
advancement in technology the United States has taken the following three prong
view. Their policy on genetically modified food 1) is product based, 2) presumes
that the risk of genetically modification is low, or equal to that of the
natural foods currently consumed, and 3) proposes that the existing federal
standards are sufficient to be applied to genetically modified
foods.
[4] The United States’
policy on genetically modified foods has been based on these principles since
1992 and has changed minimally since then. The policy of the European Union is
focused on the process of creating genetically modified foods rather than the
end product. The European Union maintains its conservative position based on the
lack of scientific knowledge of the long term effects of genetically modified
organisms. In order to ensure the safety of society legislation has been enacted
to strictly scrutinize genetically modified products and to provide notice to
the public that what they are purchasing is a product of genetic modification.
The European Union has actively been proposing legislation as new issues and
concerns arise. The European Union places a great deal of emphasis on the rights
of its citizens to be informed and their concerns about the safety of releasing
genetically modified products onto the European market place.
The purpose of
this article is to trace the history of the policies of the United States and
the European Union with regards to genetically modified products in order to see
how they have arrived at their current position. By looking at the political
histories, similar goals can be seen and used to establish a basis for
cooperation. In analyzing the similarities and differences of the two trade
powers a solution to the impasse should become apparent. If the wants and needs
of both of these trade powers can be satisfied, a compromise can be reached that
will not only benefit these two political entities, but also the rest of the
world by providing a uniform system to regulate genetically modified products
from the process of making them to their final product.
The History of the Policies of the United States with
Regards to the Regulation of Genetically Modified Products
In the early 1980s, the introduction of genetically modified foods onto the
United States market was inevitable. Congress began to conduct hearings about
the new wave of genetically modified products and to draft legislation to
specifically deal with this new
technology
[5]. The Reagan and Bush
Administrations worked at outlining a federal regulatory policy that would
maintain the United States position as a leader in the field of GM techniques
while providing for the public’s
safety
[6]. These administrations felt
that the regulation of GM techniques should avoid being burdensome and
unnecessary. With these goals in mind the Reagan and Bush Administrations
developed three major principles of United States policy: 1) the focus is on the
end product rather than process used to arrive at the GM product, 2) regulation
should be grounded in verifiable scientific risks, and 3) GM products are
sufficiently similar to current products and therefore, the existing statutes
are sufficient to regulate them
[7].
Also, to address Congressional interest in the matter, the Reagan Administration
created an inter-agency working group within the White House Office of Science
and Technology Policy (OSTP). This group was charged with drafting an overall
federal framework for the regulation of food biotechnology.
In 1986 the OSTP
finalized version of the Coordinated Framework for Regulation of Biotechnology.
This document contains an outline of the existing jurisdictions of regulatory
agencies that would oversee GM products. The three regulatory agencies listed
were the Food and Drug Administration (“FDA”), the U.S. Department
of Agriculture (“USDA”), and the Environmental Protection Agency
(“EPA”.) The FDA is responsible for regulating food and feeds. The
USDA’s Animal and Plant Health Inspection Service (APHIS) regulates the
importation, interstate movement, and environmental release of transgenic
plants. The purpose of their regulation is to protect the United States’
existing crops
[8]. Additionally, the
USDA is responsible for issuing licenses for field testing of food crops prior
to their commercial release. The EPA requires companies producing genetically
modified products to register certain pesticide products in transgenic plants
prior to their distribution and sale. It is also their responsibility to
establish pesticide tolerances for residues in foods.
After the release of
the final version of the Coordinated Framework for Regulation of Biotechnology
the White House and the above federal agencies worked together to determine how
each agency would exercise its responsibilities. The Bush Administration’s
OSTP released “Exercise of Federal Oversight Within Scope of Statutory
Authority: Planned Introductions of Biotechnology Products in the
Environment” in 1992
[9]. This
policy was framed to provide direction on implementing policy as outlined in the
Coordinated Framework for Regulation of
Biotechnology
[10]. In this draft it
stated that federal regulation should be limited to science-based risk
assessments
[11]. Additionally
another policy document released, Principles for Federal Oversight of
Biotechnology: Planned Introduction Into the Environment of Organisms with
Modified Hereditary Traits, stressed the importance of focusing regulation on
the end product rather than the process by which the product was
created
[12]. It emphasized that
regulation should be based on the characteristics and the risks of the product.
The second principle stated that while regulation should ensure the safety of
the consumer the review required should place a minimal burden on the release of
the GM product. The third principle took the second principle even further by
suggesting that regulation should accommodate “rapid advances in
biotechnology
[13].”
In 1992
a final Statement of Scope was issued by the Bush Administrations OSTP. The
policy stated “oversight will be exercised only where the risk posed by
the introduction [of GM products] is unreasonable... when the value of the
reduction in risk obtained by additional oversight is greater than the cost
thereby imposed.” Additionally, in this document five policy principles
were listed giving the clearest guidelines of the government’s stance on
GM foods. The five policy principles are:
- The same physical and biological laws govern the response of organisms
modified by modern molecular and cellular methods and those produced by
classical methods;
- Information about the process used to produce a GM organism is... not a
useful criterion for determining whether the product requires less or more
oversight;
- No conceptual distinction exists between genetic modification of plants and
microorganisms by classical methods or by molecular techniques...;
- Crops modified by molecular and cellular methods should pose risks no
different from those modified by classical methods for similar traits...;
and
- In many respects, molecular methods resemble the classical methods for
modifying particular strains of microorganism, but [are more cost-efficient and
accurate than the classical
methods[14].]
Although
this final statement of scope outlines the clearest guidelines of the
government’s position on GM products, there is no mention of what a
“measurable risk” is or how much scientific evidence is needed to
prove that a GM product is a risk to the public’s safety and should be
regulated more strictly.
Once the guidelines for scope were set forth the
regulatory agencies were responsible for taking action to implement the policy.
The FDA, USDA, and the EPA have since focused their policies on the three-part
approach developed by the White house and the OSTP.
I. The FDA’s Regulatory Policies Regarding GM
Products
The FDA’s regulatory policies focus on the principle that absent any
identifiable risk or scientific basis for concern a product may be placed on the
market. Since these products are regulated under the same standards as all
natural foods they fall under the jurisdiction of the Federal Food, Drug, and
Cosmetic Act (“FFDCA”). Under this act it is the
manufacturer’s responsibility to ensure that the product they are placing
on the market is not adulterated or misbranded. Food is considered adulterated
if it “bears or contains any poisonous or deleterious substance which may
render it injurious to
health
[15].” Additionally,
foods that contain novel ingredients are subject to a higher degree of review.
Any ingredient that is added to food must be approved as food additives or must
be considered generally recognized as safe. Under 21 U.S.C. §321(s) food
additive is defined as a substance, the use of which may “reasonably be
expected to result directly or indirectly, in its becoming a component” or
“otherwise affecting the characteristics” of the food to which it is
added. In order for a manufacturer to get approval for a food additive they must
submit a petition as set out in 21 C.F.R. part 171. This petition includes
substantial scientific evidence that the food evidence is safe and that there is
“reasonable certainty” that no harm will result from using the
additive. The scientific evidence is made up of extensive toxicity and feeding
studies. In order for approval a manufacturer must meet all of the above
requirements
[16].
However, if a
food is considered generally recognized as safe there is no need for a
manufacturer to apply for approval as a food additive or to submit to additional
screening
[17]. For a food to be
considered generally recognized as safe a great deal must be known about its
safety. If there is not enough knowledge, then the food is subject to review as
a food additive.
Because the food additive approval process is lengthy and
not much is known about the safety of genetically modified foods it could be
assumed that in order to get approval for marketing a GM product the process
would be timely and costly. Due to inquiries regarding this issue the FDA
released “Statement of Policy: Foods Derived from New Plant
Varieties” to “clarify its interpretation of the [FFDCA] with
respect to human foods and animal feeds derived from new plant varieties,
including but not limited to plants developed by new methods of genetic
modification.”
[18] The stated
purpose of this document was not only clarification; the purpose was twofold.
First it stated that the FDA’s view was that most GM products were
considered generally recognized as safe or were likely to be generally
recognized as safe. This position meant that most GM products are not subject to
review as food additives. The second purpose of the document was to outline a
voluntary pre-market consultation process meant to safeguard against erroneous
GRAS presumptions.
In 1997 the FDA released another document,
“Guidance on Consultation Procedures for Foods Derived from New Plant
Varieties,” defining the types of information the agency scientist would
like to see presented at the voluntary pre-market consultations. In addition to
reviewing information presented by the manufacturer the meeting would consist of
discussing any other outstanding issues concerning the product.
In 1999 the
FDA began to hold public hearings to address the growing public concern over the
labeling of genetically modified products. Three major themes surfaced from the
comments made at these hearings: 1) there was no evidence that would indicate
that GM foods currently on the market are
unsafe
[19], 2) whether the
FDA’s current regulatory regime was adequate to ensure
safety
[20], and 3) whether labeling
GM products should be required
[21].
January 2001 the FDA issued a response to these issues by proposing a new rule
that requires manufacturers of “plant-derived, bioengineered foods, and
animal feeds” (GM products) to notify the FDA at least 120 days before GM
products are marketed via a “Pre-market Biotechnology
notice
[22].” This proposed
rule made the voluntary pre-market consultations mandatory for manufacturers to
receive approval to introduce their GM products onto the market.
In response
to the second theme of whether the FDA’s current regulatory regime was
adequate to ensure safety the FDA published a notice on August 2, 2002,
“Proposed Federal Actions to Update Field Test Requirements for
Biotechnology Derived Plants and to Establish Early Food Safety Assessments for
New Proteins Produced by Such
Plants
[23].” This document
acknowledges that with the increased number of GM agricultural products being
approved there is a higher likelihood that conventional products will be
contaminated. It states that the three regulatory agencies will continue to
issue updated regulations and guidance with regards to the issue of
contamination as they deem relevant. Additionally, the FDA’s review of GM
products will extend to crops that are not food because they can enter the food
supply via contamination and
cross-pollination
[24].
The FDA
published “Draft Guidance for Industry: Voluntary Labeling Indicating
Whether Foods Have or Have Not Been Developed Using
Bioengineering
[25]” as a
response to the labeling issue brought up in the comments from the hearing. This
document reaffirmed that the FDA would not require special labeling of all
bioengineered foods. The reasons stated were that labeling is unnecessary
because GM products are equivalent to their conventional counterparts, labeling
would cause confusion and potentially be false and misleading. However, the FDA
did state that labeling would be mandatory if the GM product differed from its
conventional counterpart
significantly
[26]. They also offered
a list of voluntary labeling phrases that could be used by
manufacturers
[27].
Currently, it
is the FDA’s controls include 1) communicating clearly - through the
agency’s 1992 policy statement and subsequent guidance - what safety data
are necessary for its evaluations of GM food safety; 2) having teams of FDA
experts in diverse disciplines evaluate company submissions for GM foods and
request additional safety data, if necessary; and 3) tailoring the level of
evaluation to mach the degree of each submission’s novelty, thereby
assuring that staff have time to obtain safety
data
[28]. Although this is the
FDA’s current control policy it recognizes that there is room for
improvement by making the process more transparent and randomly verifying test
data that they receive from
manufacturers
[29].
II. The USDA’s Regulatory Policies Regarding GM
Products
The USDA initially took a more cautious approach than the other two
regulatory agencies even though they agreed that the existing statutory
framework and analysis based on scientific risk were the appropriate policies.
The USDA initially required that any GM product that was deemed to have the
potential to spread or cause injury to other plants was subject to a
pre-introduction permit. In addition to the pre-introduction permit process the
USDA agreed that regulation of GM products would fall under the Federal Plant
Pest Act (“FPPA”) which empowers the USDA to regulate imports and
the movement of items deemed to be “plant
pests”
[30]. The FFPA allows
the USDA to confiscate, quarantine, destroy and/or apply other necessary
measures to deal with articles infested or infected with plant
pests
[31]. In 1992 the USDA relaxed
its review by providing a notification process by which certain organisms would
not be required to enter the pre-introduction permitting process if the plant
satisfies six criteria
[32]. Again in
1997 the USDA amended its policies opening the notification process to all
plants and not just the ones that matched the six criteria under the 1992
policy, as long as they possessed the same low-risk
characteristics
[33].
III. The EPA’s Regulatory Policies Regarding GM
Products
The EPA regulates whether or not products are safe for the environment and
human use. When asked to regulate GM products in this context the EPA decided
that its current policies under the Federal Insecticide, Fungicide, and
Rodenticide Act (“FIFRA”) would provide adequate regulation for GM
plants with pesticidal
properties
[34]. No other regulations
were implemented. In 1994 the EPA issued a policy statement introducing the term
“plant-pesticide” which refers to GM products under EPA authority.
The definition of “plant-pesticide” is a “pesticidal substance
that is produced in a living plant and the genetic material necessary for the
product of the pesticidal substance, where the pesticidal substance is intended
for use in the living
plant
[35].” Additionally the
1994 policy statement provided a list of products that were exempt because their
risk was considered negligible
[36].
If products qualified for this exemption they avoided extensive pre-market
testing required by FIFRA. Also, the 1994 policy never formally addressed the
degree of testing appropriate for
plant-pesticides
[37].
In 2001
the EPA finalized the 1994 policy publication. In this rule the term
“plant-pesticide” was changed to “plant incorporated
protectant.”
[38] “Plant
incorporated protectant means a pesticidal substance that is intended to be
produced and used in a living plant, or in the produce thereof, and the genetic
material necessary for production of such a pesticidal
substance
[39].” This change in
terminology excludes plants with chance pesticidal modifications, while the
former definition included all plants with pesticidal modifications. The 2001
rule also finalized the exemptions in the 1994 policy proposal and stressed that
the focus of the EPA’s regulation would be on the pesticidal properties of
plants rather than the plants themselves.
The History of the Policies of the European Union with
Regards to the Regulation of Genetically Modified Products
Regulation of GM organisms (“GMOs”) in Europe began in the
early 1990s. The stated purpose for initiating regulation was to protect the
safety of the “citizens’ health and the environment while
simultaneously creating a unified market for
biotechnology
[40].”
In implementing legislation concerning GMOs the European Committee issued
directives and regulations to the member states of the European Union. The
member states then rewrote their existing laws to conform to the regulatory
procedures outlined in the directives and regulations.
The main legislation
under which GMOs were regulated until October 17, 2002 was Directive 90/220/EEC.
This directive authorized the experimental releases and placement of GMOs on the
market. Directive 90/220/EEC was repealed by Directive 2001/18/EEC. Directive
2001/18/EEC updated the directive of the European Parliament and Council on the
deliberate release of GMOs
[41]. This
directive provides a step by step approval process based on a case by case
assessment of the risks posed to human health and the environment. All GMOs must
submit to this process for approval before it may be released into the
environment or be placed on the market.
Directive 2001/18/EEC also
strengthens the basic principles set forth in the original legislation while
introducing the following new concepts: principles for the environmental risk
assessment; mandatory post-market monitoring requirements; mandatory information
to the public; requirement for Member States to ensure labeling and traceability
at all stages of the placing on the market; first approvals for the release of
GMOs to be limited to a maximum of ten years; the consultation of the Scientific
Committee(s) to be obligatory; an obligation to consult the European Parliament
on decisions to authorize the release of GMOs; and the possibility for Council
of Ministers to adopt or reject a Commission proposal for authorization of a GMO
by qualified majority
[42].
In
order for a GMO to get approval under Directive 2001/18/EEC the manufacturer
must first submit an application to the national authority of the Member State
where it wished to put the product on the market. Next the product is subject to
a full environmental risk assessment. When performing the environmental risk
assessment three factors are considered: the characteristics of the inserted
genetic material, the final product produced, and the environment into which the
product will be released and the possible interactions that might occur between
the product and the environment
[43].
The methodology used is as follows: identify any characteristics of the GMO(s)
which may cause adverse effects; evaluation of the potential consequences of
each adverse effect; evaluation of the likelihood of the occurrence of each
identified potential adverse effect; estimation of the risk posed by each
identified characteristic of the GMO(s); application of management strategies
for risks from the deliberate release or placing on the market of GMO(s); and
determination of the overall risk of the GMO(s). The environmental assessment
also reviews the process of creating the GMO, the risk associated with the gene
products produced by the GMO, and gene
transferability
[44]. If the GMO
receives a favorable opinion from the national authority that Member State
inform the other Member States via the Commission. If no objections arise then
consent to place the GMO on the market is granted and the product may be
marketed throughout the European Union.
If a favorable opinion is not issued
the decision is submitted to the Council of Ministers. The decision will be
adopted or rejected by qualified majority. If the Council does not respond
within three months the Commission can adopt the
decision
[45]. The public is kept
informed during this process via the
internet
[46].
Directive
2001/18/EC provides thorough and transparent guidelines concerning the release
of GMOs into the environment, but it does not cover products that are derived
from GMOs
[47]. Products derived from
GMOs are regulated by other policies such as the Regulation on Novel Foods and
Novel Food Ingredients of January 27,
1997
[48]. This regulation outlines
rules for authorization and labeling of novel foods. The definition of novel
foods includes food products containing, consisting, or produced from
GMOs
[49]. The authorization
procedure is the same as the approval process under Directive 200/18/EEC, except
the Novel Food Regulation allows a simplified procedure for foods derived from
GMOs, but no longer containing GMOs. In addition to being GMO-free the food must
be substantially equivalent to existing
foods
[50]. Under the simplified
procedure manufacturers are required to notify the Commission when placing a
product on the market. In addition to notifying the Commission the manufacturer
must provide scientific justification that the product is substantially
equivalent or it is the opinion of the authorities of the Member State that the
product is substantially
equivalent
[51].
The European
Commission has also provided legislation with regards to labeling and
containment in response to concerns expressed by its citizens. Both Council
Regulation (EC) 1139/98 and Regulation (EC) 50/2000 address the issue of
labeling and GMOs. Council Regulation (EC) 1139/98 supplies provisions for the
labeling of foods and food ingredients derived from one maize and one Soya
variety based on the presence of DNA or protein resulting from genetic
modification
[52]. Regulation EC
50/2000 requires that final products that contain additives and flavorings that
contain DNA or proteins from GMO origins be
labeled
[53]. Regulation (EC) 49/2000
proposes a 1% de minimis threshold for the presence of DNA or protein resulting
from genetic modification. Any product below this threshold does not require
labeling
[54].
On July 25, 2001
the European Commission released a proposal with the hopes of harmonizing the
community system. The proposal addressed the issues of tracing GMOs, labeling GM
fee, reinforcing the current labeling rules concerning GM food, and streamlining
the authorization procedure for GMOs in food and feed and their deliberate
release into the environment
[55].
This proposal is meant to address continuing concerns on the behalf of the
industry and consumers.
Issues that Need to be Addressed in Order to Avoid Trade
Wars
The United States and the European Union need to address two main issues in
order to begin working on a compromise. The first is the method of regulation
with regards to the health and welfare of their citizen’s and the world
population. The second is labeling of genetically modified products. With
regards to the issue of regulation there are different sub-issues which must be
addressed. The first is what approach the two political powers should take.
Should they take the United States’ approach of being product focused or
the European Union’s approach of focusing on the process or should there
be a combination approach focusing on the entire process and the end
product? The second is to explore a system of
standards. What should be considered a measurable risk and what amount or type
of scientific evidence is necessary to prove a measurable risk? It may seem
naïve to assume that a blanket standard would cover all countries. However,
this paper is only exploring the standards of the United States and the European
Union where the most pertinent issue in determining a standard is economic. The
analysis is less likely to be based on fundamental needs such as needing food
for survival. The third issue is whether or not pre and post market validation
should be implemented. Should pre-market scientific evidence of safety be
validated? Should there be post market testing to ensure that the product is
still safe after being introduced onto the market? The fourth category is what
should be regulated. Currently, regulation encompasses GM foods, GM products,
products derived from GMOs, and GM feed. The final issue is the transparency of
regulation. In comparison to the European Union the regulation policies of the
United States lack a great deal of transparency.
There are also several
sub-issues that must be addressed with regards to labeling. The first conflict
that must be addressed is whether or not labeling is necessary. Currently, the
United States has a system of voluntary labeling and the European Union has
enacted Regulations addressing the requirements of labeling. If labeling is
necessary then what products should be labeled, i.e. foods, products derived
from GMOs. Additionally, besides determining what products should be labeled,
what should the label disclose and how should it be written? Under the current
system the United States does not require labeling and the European Union does.
Due to the United States’ refusal to label GM entities, trade with the
European Union will soon cease unless an agreement on labeling can be
reached.
Analysis
As stated above the United States and the European Union must decide
whether they wish to continue to operate separately under their own systems or
reach a compromise on the issues of regulation and labeling. If each of these
powers were only dealing within their own borders continuing to implement their
current system would not cause any problems. Unfortunately, or fortunately,
depending on one’s view, these two powers are integral parts of the global
economy. The United States is a very strong exporter and the European Union
relies heavily on imports. Both are operating on the global market and their
current systems are causing friction. One would think that remaining on separate
systems is feasible because other industries, such as pharmaceuticals, allow for
separate systems in a global market. This is not the case. Currently, the United
States is in conflict with Canada because of their differences in pharmaceutical
systems. Although separate systems function for a while the increasing expansion
of the markets into a global realm are forcing a need for a singular or
compatible systems. A compromise would avoid perpetuating a trade war concerning
genetically modified products.
So far, no real efforts have been made to
reach a compromise. One example of the United States flexing its muscles and
trying to force the European Union into action is apparent in a press release by
the Office of the United States Trade Representative entitled “U.S. and
Cooperating Countries File WTO [World Trade Organization] Case Against
Moratorium on Biotech Foods and Crops: European Union’s Illegal,
Non-Science based Moratorium Harmful to Agriculture and the Developing
World
[56].” The press release
stated that the United States had filed this WTO case because the European
Union’s moratorium violates WTO rules. The rules referred to are from the
WTA agreement on sanitary and phytosanitary measures (SPS). This agreement
recognizes that countries are entitled to regulate crops and food products to
protect health and the environment, however members of this agreement must have
“sufficient scientific evidence” to justify their regulatory
policies and that these policies must be implemented without “undue
delay
[57].” Although the
United States has filed this suit the U.S. Trade Representative Robert B.
Zoellick states that “The United States will continue to work with the
European Union to manage this and other disputes in an appropriate way, and...
look forward to advancing... shared
objectives...
[58]” In reaching
a compromise rather than battling each other in the legal sense the United
States and Europe will have to find a happy medium.
The United States has
kept the theme of stressing the focus of its regulation on the end product since
it began enacting legislation during the Reagan Administration. The basis for
this decision has been their belief in the theory that genetically modified
products are low-risk because of their substantial equivalence to conventional
foods. Another argument for treating genetically modified foods as low-risk is
the theory that foods have been genetically modified for years. Plants have been
cross-bred for size, heartiness, color, and a multitude of other traits that
farmers or agriculturists believed to be beneficial. The genetic modifications
that scientists insert are equivalent to the cross-breeding genetic
modifications. The reason for maintaining a product based, low risk position has
been to allow the technology to advance without legislative burden. The United
States has been a leader in the field of biotechnology and in order to maintain
their position the government opted to streamline regulation. By claiming that
genetically modified products are substantially equivalent to conventional foods
already on the market manufacturers can avoid the lengthy approval proceedings
under the FDA and USDA. The streamlined process for approval reduces costs for
manufacturers and the regulatory agencies. Manufacturers are not required to
provide as much scientific evidence for approval and the federal agencies did
not have to hire as many specialists to review and analyze the results. However,
the FDA did begin to require mandatory consultations which increased the costs
for manufacturers and the FDA.
The European Union has continued to focus its
regulations on the process of creating genetically modified organisms rather
than solely on the end product. This focus has been a cautious approach based on
promoting safety rather than advancing technology. However, a benefit to
maintaining this cautious approach is that the importation of food products from
the United States will be much lower and that will drive up the price of
European food products. By remaining cautious the European Union is also
protecting its market. Additionally, there is a cultural argument for why the
European Union is insisting upon such a conservative system. Europeans
opposition to GMOs is believed to stem from their repulsion of the idea that the
market is being taken over by multinational companies and that there is a power
shift to the United States
[59]. Most
Europeans feel that “the last vestige of cultural identity ...they have
some control over is their choice of
food
[60].”
When genetically
modified organisms were first introduced in the European Union they were
regulated by Directive 90/220/EC. Under this regulation the European Union
approved nine agriculture biotech products for planting or import before
1999
[61]. Under Direction 90/220/EC
the commercial release of 18 GMOs has been
authorized
[62]. In 1998 the European
Union enacted a moratorium on new
approvals
[63]. Since 2001, Directive
90/220/EC has been repealed by Directive 2001/18/EC which outlined a more
intensive review and approval
system
[64]. The European Union has
not approved any new GMOs since the moratorium enacted in 1998. As of July 1,
2003 the Commission has received twenty
notifications
[65] under Directive
2001/18/EC,
[66] but has yet to
approve any GMOs. Seven of these notifications are for products that were
pending at the time that Directive 90/220/EC. Like the United States, the
European Union allows GMOs to pass through a streamlined procedure if the food
that has been derived from a GMO but longer contains GMOs and is considered
“substantially equivalent” to existing
food
[67].
The European
Union’s approval process runs against the grain of the United
State’s policy. The European Union’s legislation creates a great
burden on the introduction of GMOs onto the market and to scientific
advancement. In order for the two to agree on a policy they will have to
determine whether the United States should increase the legislation regulating
GMOs or if the European Union should relax their legislation. The United States
has the incentive to increase legislation regulation because it would open up
trade with the European Union. However, this increased regulation would be
costly and would be in opposition to promoting biotechnology. The incentives for
the European Union to loosen its regulations are promoting biotechnology,
avoiding law suits, and an increase in trade options. However, there are
drawbacks such as cultural degradation, a drop in the value of European
products, and a shift in power to parties outside of the European Union. In
order for a compromise to occur gains and losses will have to be weighed and
assumed by both parties.
Another issue that needs to be analyzed is the
position of standards used to measure the safety of genetically modified foods.
None of the regulatory measures issued by the United States formally outlines
standards for measurable risks or what constitutes sufficient scientific
evidence. The FDA publication “Guidance on Consultation Procedures for
Foods Derived from New Plant Varieties” recommends information the
manufacturer should supply at the FDA consultation. However, any data that is
supplied is taken as accurate and is not validated. The FDA has admitted that
randomly validating scientific evidence is feasible and is probably a regulatory
change that should be implemented to ensure the safety of GM products entering
the market
[68].
The European
Union has defined standards for certain regulations and directives. One example
is the one percent de minimis threshold for the presence of DNA or protein
resulting from genetic modification when determining whether or not a product
should be labeled as a genetically modified
organism
[69]. In addition to
requiring extensive scientific evidence of safety via notification under
Directive 2001/18/EC the European Union also requires that post-market release
analyses be conducted
[70]. The
requirements for notification are outlined for manufacturers in the above
directive.
In order for the United States and the European Union to reach a
compromise on the standards to be imposed it must first be determined what an
adequate standard is and how much scientific evidence is needed. For the United
States this will be a first and for the European Union it will be a continuation
of what they have already started. In reaching a compromise having a factual and
scientifically based standard should provide a solid launching point and
reference for further compromise.
Another aspect that must be discussed is
what types of genetically modified organisms should be regulated. United States
has existing legislation regarding genetically modified foods, genetically
modified feed, products of genetically modified origin, and products derived
from genetically modified organisms. Through the approval process currently in
place the United States does not grant a blanket approval to products that could
be marketed as food and feed or anything else that crosses categories. Each
product is approved on an individual basis including considering its intended
use. However, this approach has caused difficulties and public concern. In 1998
the EPA approved Starlink™
Corn
[71] for use as animal feed, but
did not approve it for human consumption. This is an example of a
“split” exemption, where a product is approved for one use, but not
another. Because the EPA granted this split exemption Starlink™ was
allowed to be grown and processed for feed. However, Starlink™ Corn is the
first test case to show contamination of other
crops
[72]. Starlink™ has been
found in Taco Bell taco shells and traces have been found in more than one
percent of samples submitted by growers and grain handlers in the past 12
months
[73]. Starlink™ is only
one example of the danger of “split exemption” and of the dangers in
the regulatory processes of the United States.
It appears that the United
States is over-regulating because of the lack of evidence of anyone sustaining
injury from consuming Starlink™ corn. This is a specific incident where
luckily no one died from anaphylactic shock due to an allergic reaction to the
GM corn. If you only look at the effect that GM foods may have on humans this
appears to be a valid argument. However, one must look at the larger picture.
For example, Bt corn is a GM corn that has been determined fit for human and
animal consumption and is currently being grown in the United States. Like
Starlink™
there have not been any reports of
injury to humans caused by the GM corn. Although there is no negative affect to
humans Bt Corn poses a “major hazard to Monarch
butterflies
[74].” One may
argue that Monarch butterflies are a small price to pay for the advances in
biotechnology, but scientists are now finding that Bt corn is also killing
“lacewings, ladybugs, and beneficial soil microorganisms” which in
turn is “damaging the entire soil food
web
[75].” Additionally, the
last recall of a genetically engineered product (nutritional supplement
I-Tryptophan in 1989) “left in its wake 37 deaths and 5,000
injuries
[76].”Although
evidence points to over-regulation on the surface, it is the unexpected that
needs to be considered.
The United States’ method of regulating based
on specific categories is erroneous. Even though one could argue that the basis
for approving plants and products should be on different scales because the
level of danger from each is dangerous is incorrect because you cannot separate
the two. If you have a GM plant and the goal for the market is the product then
you still have to produce that potentially dangerous plant to achieve the
product. Additionally, even if both plant and product are regulated separately
under the current system there are such grievous flaws as to allow unknown
dangers such as gene transposition that are creating potentially dangerous
immunities in insects and weeds. A system that allows the regulators to view the
larger picture is needed so that the unobvious connections between different GM
sources can be seen and dealt with accordingly.
The European Union also has
legislation concerning genetically modified foods, genetically modified feed,
products of genetically modified origin, and products derived from genetically
modified organisms. However, the European Union does not allow
“split” exemptions like the United
States
[77]. Also, all of these
classifications of GM products undergo the same approval process by the same
agencies. The only exception is that foods derived from GMOs that no longer
contain any GMOs are subject to a simplified
procedure
[78]. In review Directive
2001/18/EC provides thorough and transparent guidelines concerning the release
of GMOs into the environment, but it does not cover products that are derived
from GMOs
[79]. Products derived from
GMOs are regulated by other policies such as the Regulation on Novel Foods and
Novel Food Ingredients of January 27,
1997
[80]. This regulation outlines
rules for authorization and labeling of novel foods. The authorization procedure
is the same as the approval process under Directive 200/18/EEC, except the Novel
Food Regulation allows a simplified procedure for foods derived from GMOs, but
no longer containing GMOs. In addition to being GMO-free the food must be
substantially equivalent to existing
foods
[81]. Under the simplified
procedure manufacturers are required to notify the Commission when placing a
product on the market. In addition to notifying the Commission the manufacturer
must provide scientific justification that the product is substantially
equivalent or it is the opinion of the authorities of the Member State that the
product is substantially
equivalent
[82]. The European Union
recognized that by allowing “split” exemptions a situation similar
to Starlink™ in the United States may have occurred. Additionally, the
European Union’s system also allows for exports of GM foods from other
countries as long as the GM derived food would receive approval under their
system.
Due to the United States’ experience with Starlink™ it is
feasible to believe that a compromise and what should be regulated and approved
would be an easier task than compromising on some of the other issues explored.
The choice here is whether to continue to use the United States’ system of
approval or to use the European Union’s system of granting approval. The
approval process under the European Union’s system is more streamlined
than that of the United State’s under this approach. Not only to the point
that it is a great deal more difficult for GMOs to receive approval, but also in
the administration of the approval process.
Rather than
having three regulatory agencies monitoring what can or cannot be approved and
for different uses there is a single approval process that goes through the same
experts and authorities. This system reduces discrepancies and costs due to the
decreased number of channels the product must pass through before
approval.
The final issue under regulation is transparency. Currently, the
United States does not publish a great deal of information about the current
situation of regulation of GM products. What is being published is cryptic and
hard to understand to a member of the general public. These facts have been
recognized by representatives of the
FDA
[83]. FDA representatives have
agreed that implementing a system that would allow the general public to access
more information about current events with regards to genetically modified
products would be beneficial in assuaging the public’s
concerns
[84]. The FDA has also
conceded that introducing a more transparent system is easily implemented by
requiring more information be released in published reports and by creating
access via the internet
[85].
The
European Union currently has a transparent system like the one the United States
may try to achieve. Information regarding the approval process a GMO is going
through is posted and updated via a
website
[86].Here the public can
access any information obtained about the GMO through the course of the approval
process by visiting
http://gmoinfo.jrc.it/
[87].
Additionally, the members of the public are encouraged to comment on the
information on the website. This website is very informative and user friendly,
which promotes use by the public and education about the subject.
Without
meeting or discussing policy the United States and the European Union are
beginning to reach a similar position with regards to transparency of
regulation. The United States realizes that its regulatory procedures are not
transparent enough and need to be amended in order to provide more information
to the public. The European Union already recognized the importance of keeping
the public informed on such a volatile subject and has made information readily
available through the internet. A simple update in the United States system and
an agreement on the exactly how much and what kind of information should be
released would put the two trade powers in harmony.
Labeling is also a major
issue that would have to be sorted out between the United States and the
European Union if their policies were going to be harmonized or at least made
similar enough to allow for free trade between the two. The issues that should
be addressed are should labeling be required and if so what would be required to
be labeled.
The United States believes that the answer to this question is
no. Currently, there is no regulation requiring the general labeling of GM
products. The only time a GM product requires labeling is when the GM product
differs from its conventional counterpart
significantly
[88]. The reason the
U.S. cites for deterring labeling is that it may cause confusion or be
“false” or “misleading”. The U.S. does provide certain
labels that may be used by manufacturers if they wish to voluntarily label their
products.
The European Union on the other hand has required that GM products
be labeled since 1997
[89]. The label
satisfies the consumer’s right for information and allows the consumer to
make an informed decision when purchasing
products
[90]. From October 17, 2001
on Directive 2001/18/EC directs that it is the responsibility of the Member
States to take the necessary measures to ensure labeling of GMOs as or in
products
[91]. Foods and food
ingredients must be labeled under the Novel Foods Regulation and additives and
flavorings must be labeled under Regulation (EC) 50/2000 as of January 2000 if
DNA or protein of GMO origin is present in the final
product
[92]. A final proposal for
the regulation of labeling GMOs and products produced by GMOs was release on
July 25, 2001. This proposal would extend labeling to all GM food and feed
regardless of whether or not GM DNA or proteins can be detected in the final
product
[93]. As of now, there is no
specific legislation aimed at the labeling of GM feed or feed produced from GM
products
[94].
The issue of
labeling is a difficult one for the United States to compromise on due to its
existing legislation for GM foods as well as conventional foods. If a system of
labels could be created that the United States did not consider being false or
misleading and that system would comply with existing legislation. First, the
United States and the European Union must agree that labeling is required and
then decide on what should be labeled before trying to determine how the label
should read.
The United States is also concerned with labeling foods that are
traded outside of the European Union as well due to the trade agreements these
countries may have with the European Union. If countries outside the European
Union are receiving supplies from the United States that do not conform with the
European Union’s standards the European Union may cease trades with these
countries for fear of receiving contaminated articles or unlabeled products that
originated in the United States. Therefore, without the proper labeling
countries that trade with both the United States and Europe will most likely not
accept those products for fear of losing its trade partners. Currently, the
United States ships most of its agricultural exports to Asia and then the second
most is the European Union. If the United States were to resist complying with
the European Union’s labeling requirements they stand to lose a huge
portion of the export market.
Once both have agreed that a label is required
it must be determined how that label should read. Under United States law the
label must not be false or misleading. Under European Union law enough
information must be provided for the consumer to make an informed decision. A
label reading “this product does not comply with European Union labeling
requirements” would not provide much information for the consumer other
than it is in some form a GM product. The United States may also consider such
language misleading. The best solution would seem to be to affix a label reading
what type of GM product the item is and then placing something like an FDA
approval blurb, similar to a surgeon general’s warning, but a positive
message. This way the United States avoids promulgating a label that appears
negative and/or false/misleading and the European consumer can make an informed
decision.
Proposal
In order for the United States and the European to see eye to eye on the
issue of regulating genetically modified products a compromise needs to be
reached. One method of successfully achieving compromise is to begin working
with neutral organizations. The World Trade Organization conducts policy reviews
for the United States and the European Union. September 2001 the WTO reviewed
the United States’ policy on trade. It states that the United States has
made efforts to further liberalize agriculture and service in the WTO mandated
negotiations
[95].” This report
also notes the United States’ concern over trade restrictions on GM foods.
In 2002 the WTO conducted a review of the policies of the European Union. In
this report the WTO noted that the European Union’s trading partners
perceived their strict regulations as trade barriers. This raised concern about
“preserving the viability of the international standard-setting
process
[96].” The recent
changes to the European Union’s legislation were reviewed to ensure that
they complied with the WTO
rulings
[97]. The WTO’s review
of policy allows for the trade powers to express their views on each
other’s policies and to ensure compliance with world standards. By
checking to see where they stand in relation to one another the two trade powers
can determine whether or not their policies will create an impasse.
In
addition to conducting reviews the WTO allows for countries to bring disputes
against one another
[98]. As of
August 2003, the United States has filed a dispute against the European
Communities for “Measures Affecting the Approval and Marketing of Biotech
Products” and has placed a “Request for the Establishment of a Panel
by the United States
[99].”
Utilizing the dispute settlement process is good way to bring forth concerns and
to expedite or force compromise. This measure will probably bring the United
States and the European Union closer to a unified system.
Another method of
creating compromise is by forming committees that are made up of representatives
from the different specialties within the biotechnology field. The USDA’s
Office of the Under Secretary for Research, Education, and Economics established
the Advisory Committee on Biotechnology and 21
st Century Agriculture,
(“AC21”)
[100]. This
committee is made up of eighteen individuals from the biotechnology industry,
the farming community, the seed industry, food manufacturers, commodity
processors and shippers, environmental and consumer groups, academic
researchers, and experts on bioethics and legal issues. This committee has been
charged to provide information on the long-term impacts of biotechnology on the
U.S. food and agriculture
system
[101]. This committee is
also responsible for providing guidance to the USDA on individual biotechnology
issues. The European Union has also developed committees like AC21 with the
hopes of obtaining more information and guidance from all concerned members of
the biotechnology field. Although gathering information from within is
beneficial for determining what issues are raised by their citizens the United
States and the European Union are still not working on a global scale. The
British Medical Association
(“BMA”)
[102] has
published a list of recommendation regarding the impact of genetic modification
on agriculture, food, and health. One of their recommendations is that the
different world governments should consult each other and support a review of
the World Trade Agreement. The stated purpose of this unity is to ensure that it
is the governments of the world, not biotechnology companies, are deciding
whether countries “accept with, or without restrictions, the importation
and use of GM seeds, plants, of
foods
[103].”
Both of the
above proposals share the common theme of looking past one’s own policies
and working as a group to come to a decision. By first establishing what each
considers to be safe regulation within their own borders and then discussing
these policies with each other the United States and the European Union can
determine what they have to work with and exactly what aspects deserve their
focus.
Conclusion
The political histories of the regulation of genetically modified products
in the United States and the European Union show how the differences between the
two policies have resulted in the current trade war. The United States has
consistently updated regulations while sticking to these three original tenets
that regulation for genetically modified products should be: 1) product based,
2) presume that the risk of genetically modification is low, or equal to that of
the natural foods currently consumed, and 3) that the existing federal standards
used are sufficient to be applied to genetically modified foods. The European
Union has also remained true to its conservative and cautious regulation. They
have focused on the process of creating GMOs and have listened and taken into
account the concerns of their citizens.
The next step in advancing
genetically modified food technology is to reach a compromise and overcome the
current trade war. By combining the two stances of the United States and the
European Union a very safe and socially aware policy would be created. However,
a complete integration without any hiccoughs is only feasible in a perfect
world. If the two trade powers would be willing to form joint committees with
specialists from all different backgrounds in the biotechnology industry a well
rounded and mutually beneficial policy may result. The key to success is
utilization of the policies of the WTO and communication not only between
experts, but between the countries involved. Trade would resume, starving people
in Africa and other areas of the world would be fed, and the governments would
reach their goals of providing a safe environment while at the same time
promoting advancement.
Looking Towards the Future
Advances in genetic engineering are occurring more and more often as
scientists learn more about how genes work and more plants and animals are
sequenced. Within the next 50 years a majority of animals and plants should be
sequenced and their genetic code understood. This would allow scientists a
greater realm of genes to experiment with during engineering. There will be
better genes for drought resistance, pest resistance, nutritional value, growth
factors, and much more. However, with these advances also come some of the
difficulties that have already been encountered.
One is the ability for
plants to transfer the genetically engineered “superior gene.” There
have been lawsuits against farmers who have stolen the new gene because the
engineered plants cross-pollinated with the neighboring crops. If genetic
engineering is going to become a more popular choice in the United States it is
plausible that many more cases like this will start popping up. This sort of
“theft” will have to be classified and regulations pertaining to
this “theft” will have to be developed. Some factors that may be
considered in such cases are whether or not the farmer using the genetically
engineered crops took precautions to prevent cross-pollination, whether notice
was posted so that farmers not using genetically engineered crops would take
precautions to prevent cross-pollination, and what volume of cross-pollination
would constitute willful theft. A solution to “pollination theft”
would be to contain crops in green houses so that only a minimal amount of
pollen and genetically modified plant stuffs would leave the buildings with the
workers. This is a costly solution, but since we already pay farmers to not
produce crops the government could help subsidize the cost of building
containment facilities. Another more scientific solution would be to engineer
the plants so that they do not create pollen or engineer them so that they are
sterile. Currently, there are sterile plants on the market, i.e. seedless grapes
and seedless watermelon.
Another consideration for the future will be the
damaging effects of the genetically modified plants on other plants, insects,
and the environment in general. Currently, as stated above some plants, such as
Bt Corn, are having an adverse affect on insects and the soil environment. If
this trend were to continue into the future food chains and bionetworks could be
destroyed, eventually having a horrific effect on the ecosystem. However, it is
unlikely that scientists will allow this situation to progress to this extreme.
One possible solution would be to produce suppressor genes that would suppress
the genetic modifications that are causing the adverse affects. The benefit of
using this type of gene would be that scientists could try to pinpoint the genes
that are causing adverse affects and then manipulate another gene to turn that
specific one off completely or to the point that it will no longer cause harm. A
potential disaster with this solution is that the suppressor genes will
over-suppress. They will weaken the plants that were engineered to be stronger,
more resistant. In this case, suppressors themselves could also cause harm to
the environment by passing on the suppressor genes and making natural plants
weaker and more susceptible to the elements.
The best solution would be to
have a stricter monitoring system or having more conscientious scientists. The
only true way to ensure that GMOs don’t adversely affect the environment
is to impose stricter regulations on when, where, and how these GMOs can be
released into the environment.
The future of labeling in the United States
will depend on whether or not the organic and all-natural fad continues into the
future. Due to the new health-consciousness of the American public it is
probable that the trend will continue for some time. Currently, the extent of
labeling only extends to organic foods. One store, Trader Joes, informs its
customers on its websites that customers can avoid non-organic or genetically
modified foods by choosing foods that are labeled
“organic.”
[104]
Because of the government’s opposition to labeling due to the negative
implications it may have, it is plausible that only organic foods will continue
to be labeled. This would solve some trade agreements with the European Union
because they could agree to accept all foods that are labeled as organic.
One
futuristic solution would be to have all foods and products sequenced. The
European Union could then sample all imports and match their sequences to known
sequences to see if the imports would comply with their standards. If the
imports comply they could be released into the market unlabeled. Any imports
that do not comply with the correct sequences would be destroyed. Another
possible solution would be to label the products as sterile. If it is possible
to created plants and products that cannot share genes and therefore there is no
“jumping” of the genes then labeling them “sterile”
should comply with the European Union’s regulations.
[1] The term genetically modified
will be used rather bioengineered. The public is more familiar with the term
genetically modified. However, the scientific community is more likely to use
the term bioengineered. For ease of reading the term genetically modified will
continue to be used.
[3] Biotechnology companies may
soon have the ability to insert terminator genes into the gene sequence of
plants. This terminator gene prevents the plants from producing seeds that could
be used for a crop for the next season. Therefore, farmers would be required to
buy the seeds from the biotechnology companies every year.
See supra note
2.
[4] 44 B.C. L. Rev.
733,733
[5]
Id.
[6] SHELDON KRIMSKY
& ROGER P. WRUBEL, AGRICULTURAL BIOTECHNOLOGY AND THE ENVIRONMENT: SCIENCE,
POLICY, AND SOCIAL ISSUE 249-51
(1996).
[7] 44 B.C. L. Rev.
733, 738
[8] Coordinated
Framework for the Regulation of Biotechnology, 52 Fed. Reg. 23,302 (proposed
June 26, 1986)
[9] Principles
for Federal Oversight, of Biotechnology: Planned Introduction Into the
Environment of Organisms With Modified Hereditary Traits, 55 Fed. Reg. 31,118
(proposed July 31,
1990).
[10]
Exercise of Federal Oversight Within Scope of Statutory Authority: Planned
Introductions of Biotechnology Products into the Environment, 57 Fed. Reg. 6753
(proposed Feb. 27,
1992).
[11]
Id.
[12] See supra
note
9[13]
Id.
[14] See
supra note
10 at
6755
[15] Federal Food, Drug,
and Cosmetic Act § 342(a)(1), 21 U.S.C.S. § 321
(2003).
[16] 21 C.F.R.
§ 170.3(i)(2003).
[17]
21 C.F.R. U.S.C. §
321(s).
[18] Statement of
Policy: Foods Derived From New Plant Varieties, 57 Fed. Reg. 22,984 (proposed
May 29, 1992)
[19] Premarket
Notice Concerning Bioengineered Foods, 66 Fed. Reg. 4706, 4708 (proposed Jan.
18, 2001) (codified at 21 C.F.R.
592)
[20]
Id.
[21]
Id.
[22] Id.
at 4707
[23] 67 Fed. Reg.
50,578 (Aug. 2, 2002).
[24]
Id. at 50, 579
[25]
Center for Food Safety and Applied Nutrition, FDA, Guidance for Industry:
Voluntary Labeling Indicating Whether Foods Have or Have No Been Developed Using
Bioengineering (Jan. 2001) (draft), available at
http://vm.cfsan.fda.gov/~dms/biolabgu.html.
[26]
Mandatory labeling would be required in cases where the nutritional value was
completely different than that of its conventional counterpart or if its safety
differed substantially.
Id.
[27]
Id.
[28] GENETICALLY
MODIFIED FOODS: EXPERTS VIEW REGIMEN OF SAFETY TESTS AS ADEQUATE BUT FDA’S
EVALUATION PROCESS COULD BE ENHANCED, G.A.O. No. 02-566 at 2
(2002).
[29] Id.
[30] 7 U.S.C. §
150aa-jj (repealed
2000).
[31]
Id.
[32] Genetically
Engineered Organisms and Products; Notification Procedures for the Introduction
of Certain Regulated Articles; and Petition for Nonregulated Status, 57 Fed.
Reg. 53,036 (proposed Nov. 6, 1992) (to be codified at 7 C.F.R. pt.
340).
[33] Genetically
Engineered Organisms and Products; Simplification of Requirements and Procedures
for Genetically Engineered Organism, 62 Fed. Reg. 23,945 (May 2, 1997) (codified
at 7 C.F.R. §§ 340.0,
340.3).
[34] 7 U.S.C. §
136 (2000).
[35] Proposed
Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and
Rodenticide Act and the Federal Food, Drug and Cosmetic Act, 59 Fed. Reg. 60,496
(Nov. 23, 1994).
[36]
Id. at 60,501
[37]
Hearing on Plant Genome Science, Sub-comm. On Basic Research of the House. Comm.
On Science, 106
th Cong. (Oct. 19, 1999) (testimony of Janet L.
Andersen, Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs, EPA)
[38]
7 U.S.C. § 136
(2000)
[39] 40 C.F.R. §
152.3 (2003)
[40] Question
and Answer on the regulation of GMOs in the European Union, Memo/02/160
– Rev., Brussels, (July 1,
2003).
[41]
Id.
[42] Council
Directive 2001/18/EC 2002
[43] Question and Answer
on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels,
(July 1, 2003).
[44]
Id.
[45] Id.
at 3
[46] Information for the
public can be found at
http://gmoinfo.jrc.it
Memo/02/160 – Rev. pg.
3
[47] See Supra note
40
[48] Commission Regulation
(EC) 258/97
[49]
Id.
[50] Substantial
equivalence applies to composition, nutritional value, metabolism, intended use,
and the level of undesirable substances present.
Id.
[51]
Id.
[52] Commission
Regulation (EC) 1139/98
[53]
Commission Regulation (EC)
50/2000
[54] Commission
Regulation (EC) 49/2000
[55]
Question and Answer on the regulation of GMOs in the EU, Memo/02/160
– Rev., Brussels, (July 1,
2003).
[56] Office of the
United States Trade Representative, Executive Office of the President
Washington, D.C. 20508,
U.S. and Cooperating Countries File WTO Case Against
EU Moratorium on Biotech Foods and Crops, (May 13, 2003),
available
at
http://www.ustr.gov/releases/2003/05/03-31.htm.
[57]
Id.
[58]
Id.
[59] Available
at
http://www.commercialdiplomacy.org/ma_projects/ma_sandblom3.htm.
[60]
Vatican Prepares Statement on GMOs as National Debates Continue, (October
4, 2003)
available at
http://www.thehealthcrusader.com/pgs/excalibur/aritcle_2003_10_9_4628.shtml.
[61]
See supra note
56
[62] Question and Answer
on the regulation of GMOs in the EU, Memo/02/160 – Rev., Brussels,
(July 1, 2003).
[63] See
supra note
66[64]
Council Directive 2001/18/EC 2002 O.J.
(L???)
[65]
Id.
[66] Question and
Answer on the regulation of GMOs in the EU, Memo/02/160 – Rev.,
Brussels, (July 1,
2003).
[67] Commission
Regulation (EC) 259/97
[68]
GENETICALLY MODIFIED FOODS: EXPERTS VIEW REGIMEN OF SAFETY TESTS AS ADEQUATE BUT
FDA’S EVALUATION PROCESS COULD BE ENHANCED, G.A.O. NO. 02-566 AT 2
(2002).
[69] Commission
Regulation (EC) 49/2000
[70]
Council Directive 2001/18/EC 2002 O.J.
(L???)
[71] StarLink™
is a corn variety that has been genetically modified to contain an insecticidal
protein derived from a naturally occurring bacterium (Bacillus thuringiensis, or
Bt.)
available at
http://www.ncseonline.org/nle/crsreports/agriculture/ag-101.cfm[72]
Alejandro E. Segarra and Jean M. Rawson,
StarLink™ Corn Controversy:
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