UNIT IV

BIOSAFETY CONCEPTS AND ISSUES

Ethical conflicts in biotechnology - interference with nature, fear of unknown, unequal distribution of
risks and benefits of biotechnology, Rational vs. subjective perceptions of risks and benefits,
relationship between risk, hazard, exposure and safeguards, Biotechnology and biosafety concerns at
the level of individuals, institutions, society, region, country and the world. The Cartagena protocol on
biosafety. Biosafety management. Ethical implications of biotechnological products and techniques.

08 Hours
Objectives
To understand the major issues of biotechnology
To learn concepts of risk, hazard & exposure and their relation ship
To study the biosafety concepts
UNIT IV
ETHICAL CONFLICTS IN BIOTECHNOLOGY
Because modern biotechnology is still considered as a new technology and the advancement in these
areas have been so rapid, it has been the object of some doubts, fears, concerns as well as an intense
and divisive debate worldwide on the potential risks to human health, the environment and society.
Modern biotechnology has been classified as a complex emerging issue that exhibits high salience
combined with limited knowledge on part of the public. Jacques Diouf, the FAO Director-General, in
the foreword of the FAO Ethic Series (FAO 2001), mentioned that technological advances and
organizational changes affecting food and agriculture systems over the past years have been both
radical and rapid; their repercussions, however, will be felt for a long time to come and, in many
cases, the consequences may be irreversible. Science continues to broaden our horizons, offering us
new options that invariably give rise to controversy. The introduction of genetically modified
organisms (GMOs) into the environment has become highly controversial worldwide. Many
consumers, environmental groups and some scientists have voiced strong concerns over the
immediate and long term effects of GMOs on human health and environment. Broader social, ethical,
religious, and economic issues associated with biotechnology have also been raised. According to
Batalion (2000), the central problem underlying biotechnology is not just its short-term benefits and
long term drawbacks, but the overall attempt to control living nature on an erroneous mechanistic
view. We as human have conscience and religious belief. Many religions do not allow unrestricted
interference with life such as genetic engineering. The pace of discovery in genetic based
biotechnology is very rapid and there is anxiety that a kind of technological compulsion will drive
developments ahead of proper ethical consideration of their propriety (Polkinghorn 2000).

Ethical Issues
Basic categories of moral or ethical concerns regarding modern biotechnology fall into two classes:
intrinsic and extrinsic.
Extrinsic concerns
Extrinsic objection refers to the concerns regarding the application of the technologies such as the
possible risks of different application of biotechnology, consumers right and patenting issues. All
these issues need to be addressed as they have far-reaching consequences on the safety of human,
environment and society.

Environmental concerns
GMOs are novel products which have the potential to reduce or change natures biodiversity or to
upset the balance of nature perhaps in unintended ways. For example, the environmentalists are
concerned about the possibility of GM crops having herbicide or insecticide resistance to crosspollinate with wild or related species, and unintentionally create hard-to-eradicate super-weeds
respectively. There is also concern on the possibility of horizontal gene transfer of transgenic DNA
and the potential to create new viruses and bacteria that cause diseases. Certain genetic alteration in
animal or plant pathogens have led to enhance virulence and increased resistance to pesticides and
antibiotics and the potential of GMOs to harm non-target organisms have been reported. On the other
hand, the producers of GMOs claimed that their products did not harm the environment but the fact
that the risk assessment studies were carried out by those with vested interests, the results have been
questioned. At the moment, the focus of scientists everywhere has been on the development of new
biotechnology products. Little efforts have been spent on independent risk assessment studies other
than those carried out by the producers. There is a need for more comprehensive and long term studies
on the impact of GMOs on the environment.
Scientific uncertainties
Scientists do not agree about the possible consequences of genetic engineering to ecosystems, health
and environment while several others have acknowledged the possible risks of GMOs to human
health and environment. Some analysts have also recognized the inadequacies of scientific risk
assessment as a mean of predicting and assessing the likely consequences of new technologies.
According to Wynne (2002), the institutionalized expressions of the precautionary principle explicitly
accommodate recognition of scientific uncertainty as a problem - where there is scientific
uncertainty, the precautionary principle may be applied. This principle recognize the possible need to
intervene to protect the environment or health in cases when there is scientific uncertainty about the
harmful effects of whatever process in question. This is because the theoretical harm of GMOs

release into the environment, if it did occur, would be very extensive, perhaps delayed, costly and
difficult or impossible to remedy.
Consumers right to food safety and information
Basic consumer claims concerning GM food are about the rights to health to be informed and to
choose (BABAS 1999). The first one refers to food safety and the right of consumers to have their
health protected from possible hazards derived from eating GM food. Three main areas of concerns
area: toxicity, allergenicity and nutritional value. The second issue is the right of consumers to know
the information about the foods offered to them (mainly the natural or GM character of food products
and their composition) so that they can make an informed choice. This freedom is important because
there are food related religious or cultural belief such as the halal (Muslim dietary rule) and kosher
(Jewish dietary rule) practices, as well as vegetarians.
Patenting
Some of the issues in patenting of GMOs is that patenting which allows big corporations to have
monopoly of genetically modified plants and animals violates the sanctity of life (Uzogara 2000).
Many critics also oppose the fact that seeds are now regarded as propriety products, moreover with
the terminator gene technology which renders the seeds sterile (Koch 1998). The farmers are force to
buy new seeds each year from multinational companies instead of sowing seeds from previous years
harvest.
Intrinsic concerns
Intrinsic objection alleged that the process of modern biotechnology is objectionable in itself. This
belief is associated with the unnaturalness claim, changing nature and to play God. Peoples beliefs
about nature play a role in their evaluation of the products of biotechnology (BABAS 1999). They
embody values and prescriptions about what is morally right or wrong to do to the natural world. The
argument is as follows: Nature and all that is natural is valuable and good in itself; all forms of
biotechnology are unnatural in that they go against and interfere with nature, particularly in the
crossing of natural species boundaries. In some cases the general moral concerns include a religious
dimension when they are accompanied by an underlying set of religious beliefs and principles
concerning the relationships between God, nature and human beings (BABAS 1999). The central
problem underlying biotechnology is not just its short term benefits and long term drawbacks, but the
overall attempt to control living nature on an erroneous mechanistic view (Batalion 2000). Many
religions does not allow unrestricted interference with life such as genetic engineering (Epstein 1998).
In Islam for example, scientific research is encouraged in order to understand natural phenomenon
and the universe, and to observe the signs of Allahs glory and ultimately to find the truth (Hajj
Mustafa 2001). However, not everything that is applicable is necessarily applicable, it is important to
consider fully the purpose and any harmful effect towards human, environment and society and must

be in line with the rules of Shariah (9th FiqhMedical Seminar 2002; Hajj Mustafa 2000). Issues of
halal products and sources of genes are also important for the Muslims and the second issue, for the
vegetarians too.

RATIONAL V/S SUBJECTIVE PERCEPTIONS OF RISKS AND BENEFITS

Risk perception has become an important topic to policy makers concerned with transport and safety
issues of BT products. Risk perception is related to conceptions of knowledge which stress the limits
of science and different, ways of knowing.
It is the subjective judgement that people make about the characteristics and severity of a risk. The
phrase

is

most

commonly

used

in

reference

to natural

hazards and

threats

to the

environment or health, such as nuclear power. Several theories have been proposed to explain why
different people make different estimates of the dangerousness of risks.
When evaluating public perceptions of risk and their implications for risk management, it is
instructive to examine the concept of risk itself. It contains elements of multidimensionality and
subjectivity that provide insight into the complexities of public perceptions.
Subjective perception is the manner in which an individual views the risk based on the workings of
his own brain and sensory systems. Each individual has a brain, sensory systems, and cognitive
structures that differ from those possessed by everyone else. As such, one cannot conclusively say that
he hears or sees exactly what other people hear or see. The problem of subjective perception is very
important in philosophy, brain science, and psychology, and is a significant barrier to establishing the
conclusive objectivity of scientific findings. Perception can be shared only through communication,
and no form of communication exists that can perfectly express one person's perception to another.
In rational perception, behaviour is guided more by conscious reasoning than by experience, and not
adversely affected by emotions. In this thinking process employs logical, objective, and systematic
methods in reaching a conclusion or solving a problem.
There are many approaches by which risk perception has been studied:
Studies within the axiomatic measurement paradigm have focused on the way in which people
subjectively transform objective risk information (i.e., possible consequences of risky choice options
such as mortality rates or financial losses and their likelihood of occurrence) in ways that reflect the
impact that these events have on their lives. Studies within the socio-cultural paradigm have examined
the effect of group- and culture-level variables on risk perception. Research within the psychometric
paradigm has identified peoples emotional reactions to risky situations that affect judgments of the
riskiness of physical, environmental, and material risks in ways that go beyond their objective
consequences.

BIOTECHNOLOGY AND BIOSAFETY CONCERNS

Biosafety is an emerging discipline built from traditional risk assessment and risk management
rationale originating from chemistry, toxicology, microbiology, epidemiology, ecology, human and
veterinary medicines, agronomy and all related basic or engineering sciences. It is composed of a
spectrum of ways of thinking from the pure scientific analytical way to the most global conceptual
way merging regulatory science, ethical issues, economics, and sociology.
Biosafety is basically a case by case methodology exploiting pertinent safety criteria embedded in the
history of sciences and of human practices. Risk assessment is and must be science-based only.
However risk-assessment is evaluating multi-factorial situations and necessarily only leads to a set of
certainties but also of uncertainties. Risk management leads to a binary decision: should an activity or
a product be authorised or not, given a certainties/uncertainties ratio. Risk communication motivates
the final decision and is a complex mixture of local and transboundary education, information and
public interaction, dialectics, democratic respect, and transparency.
Biosafety concerns
Major biosafety concerns related to biotechnological applications are:
Gene flow - The movement of genes between genomes of species or between environments is termed
gene flow. However, from the biotechnology point of view gene flow is the possibility that GM crops
can hybridize with other related species and their wild relatives which leads to the transfer of the
transgenes from the GM crops to their wild counterparts. Engineered genes i.e. transgenes from GM
crops might escape and be incorporated into wild populations affecting the genetic consequences of
advancing generations. Studies with transgenic herbicide-tolerant rapeseed (Brassica napus) in the
UK, showed that the gene flow rates through cross pollination ranged between 0.0156% and 0.0038%
at 200 m and 400 m, respectively. On one hand agro-biotechnology has the potential to introduce the
trait of interest, on the other hand it also includes the risks of genetic movement of genes that
otherwise would not exist in plants.
New Weeds - Most of the genetic transformation now a day is being done for herbicide tolerance or
insect resistance which is beneficial to protect our crops. However gene flow due to cross pollination
for the traits involving resistance can result in development of tolerant/resistant weeds that are
difficult to eradicate. The development of resistance in organisms naturally is a long term
evolutionary process but incorporating resistance gene through cross pollination among the
compatible genomes could speed up this process considerably. Transgenes might lead to the
superweed evolution that confers a competitive benefit to the GM crop species wild relatives.
Threat to Genetic Diversity - A plant acquiring insect or disease resistance genes will have more
chances to become popular within a short time because of its enhanced fitness and preferential

selection. This selection results in a shift in the original population structure. The selection would
affect not only the concerned locus in which the wild-type alleles would be lost but also other loci that
are closely linked to the fixed new alleleleading to a final danger of genetic erosion.
Antibiotic resistant - Horizontal gene transfer (HGT) etween bacteria and plants in either the soil or
gut has been seen as a hazard associated with transgenic plants, particularly when this is related to the
possible transfer of genes encoding antibiotic resistance.
Impact on non-target organisms - It is feared that the toxins produced by genetically engineered
resistant plants may adversely influence non-target insect species which either live foraging on the
toxin carrying plants or prey on in sects that forage on such plants. Another concern on impacts of
biotechnology is the probable harm of GM crops and their seeds to other, beneficial non-target
organisms.
Trade Dilemmas - The conservation of agrobiodiversity is worldwide issue for the present era. Any
threat associated with biodiversity need to be handled with extra care because of the ease with which
plant materials can cross national boundaries, the common example being air-borne pollen. In this
regard international agreements about the movement of plant materials are of high relevance to the
regulation of agro-biotechnology for the nations. Weak and faulty regulatory systems in developing
nations are the drawbacks which allow international agribusinesses and industries to promote genetic
engineering technology without considering its impacts.
RISK, HAZARD, EXPOSURE & SAFEGUARDS
Hazard is the potential of a substance to cause damage. Toxicity is the hazard of a substance which
can cause poisoning.
Risk is a measure of the probability that harm will occur under defined conditions of exposure to a
chemical
If there can be no exposure to a chemical, no matter how dangerous (hazardous) it may be, there is no
risk of harm. The relation of risk to hazard may be expressed as;
R = f (H x E) = f (H x D x t)
Where R is risk, f is function of, H is hazard, E is exposure, D is dose and t is time
Thus, chemicals which pose only a small hazard but to which there is frequent or excessive exposure
may pose as much risk as chemicals which have a high degree of hazard but to which only limited
exposure occurs

General Principles of Risk Assessment

The safety of any biotechnological application, like the safety of any human activity, is achieved by
carrying out two sequential steps:

Assessing the risks - Risk assessment is defined as an estimation of risks in terms of

likelihood of occurrence of hazards and severity of their consequences (damages).

Minimizing the level of risks, where indicated by the results of the risk assessment, either by
applying adequate management strategies, or by deciding not to carry out a given activity if
the risks are unacceptable.

When applying these general principles to biotechnology, the risk assessment should take account of
the following points:

The characteristics of the organisms involved, including any newly introduced traits;
The intended use(s) of the organisms (contained by physical, chemical and/or biological

barriers versus released into the environment);

The characteristics of the area where the biotechnological process, activity or release will take
place; and the interactions between these.

The risk assessment is performed to protect the human health and the environment from any adverse
effect. It is based on the principle of familiarity; i.e. knowledge of, and experience with the organisms
used and their historical exploitations. Familiarity does not necessarily imply that the organism is
safe. On the other hand, lack of familiarity with a novel organism used in a particular new manner
does not necessarily mean that the process is hazardous. In that case, risk managers have to cope with
uncertainties.
Steps of risk assessment
First step - Identify Hazards
The first step is to define the hazard and nature of harm. A hazard is a property or situation that, under
certain situations, can cause harm to your health. Certain diseases occur as part of the normal aging
process. However, being exposed to certain chemicals can increase the chances of certain diseases.
Second step - Assess Exposure
After identifying the hazard, it can be determined if being exposed to certain chemicals can increase
the chance of unwanted effects such as disease. The exposure assessment determines the type,
intensity, frequency, and duration of the human exposure to a specific substance. For someone to be
exposed, the hazard has to be present in the same time and place. The person can only be affected in
the right time and place. This means, if there is hazard present but there is no exposure, then there is
no risk.
Exposure to a substance can occur through many ways. Some of these are swallowing, breathing in,
absorbing the, substance through the skin

Third step - Evaluate Dose Response

If a person is exposed to a hazard it does not mean that he/she will show any symptoms or get a
disease.
The effects most likely happen to the internal organs.
Checking the response to the dose of exposure will tell if the amount of the hazard the person was
exposed to can cause harm.
Dose Amount = Harm Response
The Dose-Response Relationship (or curve) gives information about the link between the amount of
exposure and the response shows how different levels of exposure can change the response (health
effects). The figure below shows two different types of dose-response relationships.

These

curves

estimate how different levels of

exposure to a contaminant change the probability and severity of the health effects. The threshold is a
dose level under which there is no observed response. Results from animal and human research are
used for the dose-response relationships.
Fourth step - Characterize Risk
Risk characterization combines hazard identification, exposure assessment, and dose response
assessment. It is a tool to predict the chance that a harmful event will occur in a particular population.
The goal of risk characterization is to sum up the key results of all the assessments. It must be done in
a clear, constant, and coherent way. In general, the results will include the impact to subpopulations,
doubt, and the type of study needed for future actions.
Classification of Natural Organisms on the Basis of Hazard
For natural organisms, hazard identification always relates to the pathogenicity of the organism and to
the potential for epidemics. It is important to recall that the great majority of micro-organisms are
harmless and many are beneficial. About 90 percent of micro-organisms used in biotechnology are
harmless, either as wild types or mutant derivatives thereof. Nevertheless, pathogenic microorganisms receive much attention because they represent a threat for the human health, the agriculture
or the environment.
Several attempts have been made to classify human, animal and plant pathogens according to the risks
they present to the laboratory staff first, and next to the collectivity and the environment should they

escape from the biotechnological process or from the laboratory. A worldwide agreement exists on the
four-group classification system (Table 1) for human pathogens (bacteria, fungi, viruses and parasites)
ranking from those that pose no or negligible hazard (class /group 1) to those responsible for very
serious diseases (class/group 4).
Risk Group I (low individual and community risk). A microorganism that is unlikely to cause human
disease or animal disease of veterinary importance.
Risk Group II (moderate individual risk, limited community risk). A pathogen that can cause human
or animal disease but is unlikely to be a serious hazard to laboratory workers, the community,
livestock, or the environment. Laboratory exposures may cause serious infection, but effective
treatment and preventive measures are available and the risk of spread is limited.
Risk Group III (high individual risk, low community risk). A pathogen that usually produces serious
human disease but does not ordinarily spread from one infected individual to another.
Risk Group IV (high individual and community risk). A pathogen that usually produces serious
human or animal disease and may be readily transmitted from one individual to another, directly or
indirectly.
Assessing Risks of Genetically Modified Organisms
The assessment of the risks of GMO's and their uses should be based on the full set of their
characteristics rather than on how they were obtained.
An assessment of the risks to human health and the environment associated with the use of a GMO is
based on the following key parameters, when applicable:
(i) The novel organism, taken into account

The recipient/parental or host organism;

the donor organism;
the vector used;
the insert or the introduced trait;
any empirical data on the novel organism:

(ii) The intended use (contained or release), including the scale and any management procedures;
(iii) The potential receiving environment.
Chiefly, the choice of these criteria means that the risk groups/classes system is equally valid for both
genetically modified organisms and for "natural" ones taking into account genetic and ecological
mechanisms occurring in the environment such as gene flow, invasion, persistence and dissemination
potential, fitness and impact on the biodiversity.

Model Questions
1. Explain the ethical issues of biotechnology.
2. Explain the concept of playing god with reference ethical conflict.
3. Discuss the biosafety concerns of biotechnology products & techniques.
4. Write a brief note on risk assessment process.
5. Write a note on risk, hazard, exposure & safeguard.
6. Explain the Cartagena protocol on biosafety.
7. Brief about risk assessment of GMOs.

UNIT VII
ECOLOGICAL & FOOD SAFETY
The GM-food debate and biosafety assessment procedures for biotech foods & related products,
including transgenic food crops, case studies of relevance. Key to the environmentally responsible use
of biotechnology. Environmental aspects of biotech applications. Use of genetically modified
organisms and their release in environment.
06 Hours
Objective
To understand the principle and method of evaluation of safety of GM food
To learn the environmentally responsible use of biotechnology
To study the environmental applications of biotech
To study the principles & regulations involved in the release of GMOs into environment
UNIT VII
Biosafety assessment of GM foods
To evaluate the safety of food derived from genetically engineered plants, the first step should be to
determine an appropriate comparator with a history of safe use. The comparator is usually a
traditional crop/food or other edible variety from the same species from which that GM crop/food was
developed and preferably the direct parental line.
The steps involved in the assessment of GM foods are:
I.
II.
III.

I.

Compositional Analyses of Foods Derived from Genetically Engineered Plants

Assessment of Possible Toxicity of Foods Derived from Genetically Engineered Plants
Allergy Assessment of Foods Derived from Genetically Engineered Plants

Compositional Analyses of Foods Derived from Genetically Engineered Plants :

As part of the safety testing for crops containing transgenes, studies are undertaken to investigate the
biochemical composition of tissues that may be components of food or feed. Food composition is
concerned with both beneficial and harmful components in the human diet including nutrients,
bioactive non-nutrients, antinutrients, toxicants, contaminants and other potentially useful and
dangerous elements. Based on the comparative approach of the concept of substantial equivalence,
compositional data are used as a starting point to guide the subsequent direction of the safety
assessment process based on whether there are significant deviations in composition that would
warrant further safety investigation.

Key nutrients or key antinutrients in a particular food are defined as those that may have a substantial
impact in the overall diet. They are generally major constituents namely proteins, carbohydrates, fats
as nutrients or enzyme inhibitors as antinutrients or minor components like minerals and vitamins.
Key toxicants are those toxicologically significant compounds known to be inherently present in the
plant, such as glycoalkaloids in potatoes, glycosides in cassava, and high levels of selenium in wheat.
Another key component that is also targeted for testing is allergens.
In evaluating the safety of transgenic crops through compositional comparison, the concentration of
each component in the transgenic crop is compared to the concentrations in non-transgenic
counterparts which are preferably the parental lines.
II.

Assessment of Possible Toxicity of Foods Derived from Genetically Engineered Plants

The approach used for the assessment of potential toxicity in foods involves biochemical
characterization of the new product from the inserted DNA element. The new substances can be
conventional components of plant foods such as proteins, fats, carbohydrates, or vitamins. Potential
toxicity of substances that have not previously been consumed in food is assessed on case-by-case
basis. The type of studies to be performed on these substances may include studies on metabolism,
toxicokinetics, sub-chronic toxicity, chronic toxicity, reproduction and development toxicity
according to the traditional toxicological approach using animal models.
In the case of proteins that are the product of genetic modification of a plant through genetic
engineering, the assessment of potential toxicity is carried as follows;
Determination of amino acid sequence similarity between known protein toxins and
antinutrients and that of the introduced protein. For these comparisons, public domain
database are used including GenBank, EMBL, PIR and Swiss Prot. Similarity to a known
toxin could lead to toxicological testing to address the potential impact of the homology.
In vitro digestibility studies are performed to determine the resistance of the novel product to
acid by simulating the conditions in gastric and intestinal (GI) fluids. Proteins that are broken
down in the GI system are more likely to be safe following oral consumption than those that
resist digestion
Stability of the protein to heat and/or processing is also assessed.
Acute (14 days) oral toxicity studies based on animal models. If acute toxicity tests are not
conclusive, there may be a need for additional subchronic (between 3 and 12 months) and
chronic (long-term) toxicity testing

III.

Allergy Assessment of Foods Derived from Genetically Engineered Plants

A food allergy is a reaction of the immune system to an otherwise harmless food or food component.
A major allergen is defined as that which elicits a specific Immunoglobulin E (IgE) antibody response
in more than 50% of affected individuals.
In the safety assessment of food produced through agricultural biotechnology, the assessment of the
potential allergenicity of the novel proteins introduced into these foods is one of the key issues. There
is no single predictive test for the potential allergenicity of any novel protein. The strategies followed
for the assessment of the allergenicity of the novel protein are
(i) source of the gene, (ii) A comparison of the sequence homology of the newly introduced protein to
known allergens, as is done with known toxins and antinutrients, (iii) the immunoreactivity of the
novel protein with serum IgE from individuals with known allergies to the source of the transferred
DNA, (iv) the resistance of the novel protein to digestion with pepsin and, (v) the immunogenicity of
the novel protein in appropriate animal models.
Case study
The sale of food derived from high oleic acid soybean lines G94-1, G94-19 and G168 (Application
A387) was approved in Australia and New Zealand in November 2000, following completion of a
comprehensive safety assessment. Food Standards Australia New Zealand (FSANZ) conducts the
safety assessments of genetically modified foods based upon internationally accepted principles for
establishing the safety of foods derived from GM plants. The findings of the FSANZ safety
assessment were published as the Final Risk Analysis Report: Application A387 - Food derived from
high oleic soybean lines G94-1, G94-19, and G168.
Three lines of a new variety of soybean (G94-1, G94-19 and G168), high in the monounsaturated fatty
acid oleic acid, were generated by the transfer of a second copy of a soybean fatty acid desaturase
gene (GmFad 2-1) to a high yielding commercial variety of soybean (line A2396). The fatty acid
desaturase is responsible for the synthesis of linoleic acid, which is the major polyunsaturated fatty
acid present in soybean oil. The presence of a second copy of the fatty acid desaturase gene causes a
phenomenon known as gene silencing which results in both copies of the fatty acid desaturase gene
being switched off , thus preventing linoleic acid from being synthesised and leading to the
accumulation of oleic acid in the developing soybean seed.
Other genes transferred along with the GmFad 2-1 gene were the uidA gene and the bla gene. The
uidA gene is a colorimetric marker used for selection of transformed plant lines during the soybean
transformation procedure. It codes for the enzyme -glucuronidase and is derived from the bacterium
Escherichia coli. The bla gene is a marker used to select transformed bacteria from non-transformed

bacteria during the DNA cloning and recombination steps undertaken in the laboratory prior to
transformation of the plant cells. It codes for the enzyme -lactamase and confers resistance to some
-lactam antibiotics, such as penicillin and ampicillin. The use of the bla gene as a selectable marker
was not considered to pose any safety concerns.
The transferred genes were all found to be stably integrated into the genome of the high oleic acid
soybean lines and are all phenotypically and genetically stable over multiple generations and in
various environments. Extensive analyses of the high oleic acid soybeans demonstrated that none of
the transferred genes give rise to a protein product, meaning no new proteins are expressed in any of
the high oleic acid soybean lines.
The composition of the high oleic acid soybeans was compared to that of the elite soybean line from
which they were derived. These comparisons examined the key nutrients, toxicants and anti-nutrients
of soybeans, as well as the protein profile. Soybeans contain the toxicant lectin as well as the antinutrients trypsin inhibitor and phytate. The high oleic acid soybean lines exhibit slightly elevated
lectin levels when compared to the control but these levels are well within the literature reported
range for soybeans.
Comparisons were also made with the levels of various macro- and micronutrients. Proximate (crude
fat/protein, fibre, ash), amino acid, fatty acid, vitamin and mineral, and isoflavone levels were
measured. These analyses confirmed that the high oleic acid soybeans are significantly changed with
respect to their fatty acid profile. The mean oleic acid content has been increased from 23.1% in the
parental soybean to 83.8% in the high oleic acid soybean lines and the linoleic acid content has been
concomitantly decreased from a mean level of 55.4% to a mean level of 2.2%. Small reductions in the
levels of palmitic and linolenic acid were also observed. High oleic acid levels are found in other
commonly consumed premium edible oils.
The compositional analyses revealed the unexpected occurrence of trace amounts (less than 1%) of an
isomer of linoleic acid which is not found in parental soybean line but is normally found in commonly
consumed foods such as hydrogenated soybean oils and butterfat.
The seed storage proteins of soybeans, which comprise a number of naturally occurring allergens
were also compared. Although no new proteins are expressed in any of the high oleic acid soybean
lines, they were found to exhibit a slightly altered seed storage protein profile. Allergenicity testing
confirmed, however, that the altered protein profile does not give rise to any significant differences
between the allergen content of the high oleic acid soybeans and the parental soybean line A2396. Nor
did the altered protein profile lead to significant changes to the total protein content of the high oleic
acid soybeans. In all other respects, the high oleic acid soybeans were found to be compositionally
equivalent to the parental soybean line and other commercial varieties of soybean.

Animal feeding studies with pigs & chicken confirmed that the high oleic acid soybeans are
equivalent to other commercial varieties of soybean with respect to its ability to support typical
growth and well-being. Human nutritional impact study concluded that the use of high oleic acid
soybean oil might lower dietary linoleic acid intake somewhat (by an absolute maximum of 29%), but
it would not do so to any level that would be a public health concern in terms of cardiovascular
disease. Overall, the conclusion of the study was that the nutritional impact of the use of high oleic
acid soybean oil was likely to be beneficial because diets incorporating high oleic acid soybean oil
show decreased saturated fatty acid intakes and this is likely to reduce risk factors for cardiovascular
disease.
Key to the environmentally responsible use of biotechnology
The release of a GMO into the environment means an introduction of the GMO into the environment,
without any precise confinement measure being taken to restrict the contact between this GMO and
the population or the environment in general. There are two broad categories of release of GMOs into
the environment:

The experimental release of GMOs into the environment - that is, the introduction of GMOs
into the environment for experimental purposes, also commonly known as field or clinical
trials. These types of releases are mainly carried out for the purposes of study, research,
demonstration and development of novel varieties. The behaviour of the GMO in an open
environment and its interactions with other organisms and the environment are studied. In
legislation, these releases are referred to as Part B releases.

Release of GMOs into the environment by placing on the market for commercial purposes - if
the results of the experimental release are positive, the company may decide to place the
GMO on the market, that is, make it available to third parties either free of charge or for a fee.
The GMO may be placed on the market for purposes of cultivation, importation or
transformation of GMOs into industrial products. In legislation, these releases are referred to
as Part C releases.

Regulation of introduction of GMOs into environment

Although considerable work has been carried out in the field of GMOs and a large amount of data has
been gathered, there are still concerns as regards the safety of human health and the environment.
Consequently, in many countries strict regulations controlling the release of GMOs into the
environment are being into force. The regulations apply to all GMOs, although plants have been the
subject of most interest in recent years. The legislation adopts a step-by-step approval process on a
case-by-case assessment of the risks to human health and the environment before any GMO, such as
maize, tomatoes, or microorganisms, can be released into the environment.

The entire regulatory process is underpinned by a detailed environmental risk assessment, prepared by
the applicant, who examines and evaluates any possible harmful consequences of releasing a
particular GMO. A regulatory body reviews this assessment with the help of its advisory committee.
Products derived from GMOs, such as paste or ketchup from a GMO tomato, are not covered by these
regulations.
The key stakeholders who may be affected by these regulations include:

importers of seeds, grains and crops

importers of other organisms, such as animals and micro- organisms

farmers

research institutions including biotech companies.

Legal requirements and obligations

Any release of GMOs into the environment must comply with the provisions of regulatory act. The
legal requirements and obligations of various legislation include:

observing the laid down principles for the environmental risk assessment

mandatory post-market monitoring requirements, including long-term effects associated with

the interaction with other GMOs and the environment,

mandatory information to the public

a requirement for Member States to ensure labelling 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

phasing out the release of GMOs containing antibiotic resistance marker (ARM) genes, which
may have adverse effects on human health and the environment

an obligation to consult the Scientific Committee(s) / European Food Safety Authority

(EFSA)

the possibility for the Council of Ministers to adopt or reject a Commission proposal for
authorisation of a GMO by qualified majority

Principles for the environmental risk assessment

The safety of GMOs depends on the inserted genetic material, the GMO that is produced, the
receiving environment and the interaction between the GMO and the environment. The objective of
the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s),
direct or indirect, immediate or delayed. The environmental risk assessment also requires evaluation
in terms of how the GMO was developed and examines the potential risks associated with the new
GMO (for example toxic or allergenic proteins), and the possibility of gene-transfer (for example of
antibiotic resistance genes).

The risk assessment methodology is as follows:

identification of 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 resulting from the experimental release or
placing on the market of GMO(s)

determination of the overall risk of the GMO(s)

In addition to this in order to release any GMO into environment for experimental purpose proper
approval has to be taken from concerned regulatory authority. The process of approval involves the
steps such as submission, review and decision making. Whereas the processes of approval for
marketing of GMOs are submission, review, consultation, decision making, placing in the market and
public participation & consultation.

Plant breeders' rights (PBR), also known as plant variety rights (PVR), are rights granted to the
breeder of a new variety of plant that give the breeder exclusive control over the propagating material
(including seed, cuttings, divisions, tissue culture) and harvested material (cut flowers, fruit, foliage)
of a new variety for a specific number of years. With these rights, the breeder can choose to become
the exclusive marketer of the variety, or to license the variety to others.
The holder of the plant breeders rights respecting a plant variety has the exclusive right to sell, and
produce for the purpose of selling, propagating material, as such, of the plant variety. To make
repeated use of propagating material of the plant variety in order to produce commercially another
plant variety if the repetition is necessary for that purpose.

In order to qualify for these exclusive rights, a variety must satisfy certain criterion
Novelty
Distinctiveness
Uniform and stable.
Licensing
Licensing is an agreement under which the owner of a patent, trademark or other intellectual property
gives permission to another company to use the technology developed by him (her), in a certain area
during a certain period of time.
There are two main types of licenses: 1) one which grants an exclusive right to use the technology; 2)
another with non-exclusive right, which implies that the patent owner may transfer the right to use the
technology to other companies in the same area.
Additionally, the licensing agreement could include a sublicensing clause which permits the licensee
to grant to someone else the right to use the technology.
The advantage of buying a license/patent is that it has lower costs, compared with other technology
transfer methods. However, the purchase of a license requires sufficient knowledge, experience,
relevant expertise and manufacturing base for the further in-house technology implementation.
Support Contract
According to this agreement, the technology owner participates in the technology implementation,
providing at each stage of the transfer technical support, as well as personnel training.

The involvement of technology developer in the technology transfer process ensures a closer
cooperation between two parties which favors a complete transfer of all knowledge and skills related
to the technology. In this way, the support contract may be a part of the licensing agreement, in order
to improve the transfer efficiency.
Joint Venture
A joint venture is an agreement concluded between two or more companies in order to execute a
particular business. The joint venture implies mutual assets, management, risks, profit sharing, coproduction, services and marketing.
Benefits from a joint venture in case of technology transfer are the following: long-term cooperation
between the parties, motivation of all participants in the successful transfer, lower costs than if the
companies have been working separately.
The disadvantages of a joint venture are often associated with the different vision and goals of both
partners, their inability to be independent in management. Also, companies are not always able to
determine objectively the value of capital contributed by each of them and, therefore, subsequent
profits distribution. (The foreign company provides innovative technology and management
competence, while the local company is familiar with the market and regulation. Finally it is difficult
to determine the value of each asset).
Franchising
Franchising is an agreement where one company grants to another the right to use its trademark and
business model. The buyer of the franchise starts manufacturing and selling the goods according to
the sellers specification. Normally, the company owner of a trademark also shares its experience in
operating and managing the franchised product/technology.
The main advantage of franchising is the fact that the company gets an already-made brand. With the
franchised product, the company acquires a proven business model, knowledge in management and
marketing.
The disadvantages are the companys dependence on the technology owner. In most cases, the
company has to purchase raw materials, equipment and other products from specific vendors. It must
follow internal rules and procedures of the technology owner. Generally, the company cannot bring
the product to other markets as well as sale the franchise. In addition, the decline of the franchise
owner reputation could have an impact on the company that has bought its franchise.
Strategic Alliance

A strategic alliance agreement is usually concluded between two or more big companies in order to
use specific skills of each of them in the development of new innovative technologies. Strategic
alliance could be in form of joint laboratories, research programs, production and promotion of a new
product.
Typically mutual efforts of different partners give better results than an independent development of a
new technology. During joint operations, each company can get the needed experience in new areas
and in different forms of management.
The major weakness of strategic alliances is the complexity in managing companies with different
cultures. There will be at least two teams of managers with different approaches. The companies may
have different goals and strategies in further business development of the new technology.
Turnkey Agreement
In case of a turnkey agreement, the general contractor is responsible for all the procedures related to
technology transfer, such as technology design, financing, equipment supply, construction and
commissioning.
The advantages of a turnkey agreement are that the company concludes a contract only with one
supplier who takes full responsibility for the project execution; except a force majeure, the project
will have a fixed price; the supplier guarantees the performance and the efficiency of technology.
The disadvantages could be the following: company should know in advance all the features and
output parameters which the technology should have after its launch; a complex or large-scale
technology requires a deep knowledge in the corresponding field (in this case an independent expert
organization could be employed to determine the technologys features and output characteristics);
transfer price under a turnkey agreement is generally much higher than with any other method (the
more risks the supplier takes, the higher the price is); during the transfer implementation, a company
doesnt have full control over the progress and quality of each stage of the transfer; contractors
financial problems may lead to the project suspension (it is difficult for company to determine
suppliers financial capacity and its ability to self-finance all stages of the transfer).
One of the ways to reduce the risks of the turnkey agreement is to involve the supplier in the capital of
the new entity. This will motivate the supplier to ensure the quality of the new technology, as well as
it will bring the suppliers experience in the further operational processes.
Equipment Acquisition

Equipment Acquisition is a simple and, therefore, one of the most common methods of technology
transfer. The main disadvantage of this method is the fact that the company limits itself to mere
technical knowledge incorporated in the equipment and does not get any new competences in the
management and production. Moreover, equipment available on the market does not give unique
privilege to the buyer, as this equipment may be purchased by any other competitor.
Management Contract
Technology can be transferred through a competent expert, who could be entice from another
company.
This method of technology transfers involves minimum costs. But, generally, it can be effective only
for small projects with relatively simple technology. Furthermore, technology should not be patented.
Foreign Company Acquisition
A company may acquire a foreign startup which is developing a new technology. As a result, the
company will not only get the technology, but also a team capable to develop it in the future.
Moreover, the acquisition of a foreign firm automatically places the company on the new international
market.
Among the main risks of buying an existing firm, is the possible resignation of key employees after
the acquisition. Besides, the founders of the successful startup would agree to sell it only for a price
significantly higher than the market. This increases the risk of the profitability in the future.
Direct Foreign Investments
Direct foreign investments is one of the main methods of technology transfer at the state level.
Generally, a foreign company invests in developing countries in order to create a new market, remove
export barriers and get an access to cheap labor.
In this case, a developing country gets all the benefits of technology transfer, particularly the
development of its own research environment. Besides, it is a way to create new jobs and raise taxes.
However, to attract foreign investors, the developing countrys government, generally, has to make
some concessions in its policy. As we can see in practice, without these concessions large
international corporations are not motivated in long term investments in developing countries.
Buy-Back Contract
A buy-back contract is a form of agreement between developing countries and large foreign
companies. Under this agreement, a foreign company supplies industrial equipment in exchange for
profits derived from the sale of raw materials or goods produced on this equipment. This kind of

technology transfer is often used in the construction of new plants in the developing countries. In that
case the state becomes a shareholder in the created enterprise.
For a developing country this represents a possibility to get a high-tech equipment without direct
investment in it. Moreover, the foreign company is responsible for the performance of supplied
technologies.
Potential disadvantages of a buy-back contract are the motivation of the foreign company to start
production at least costs which, certainly, will affect the execution quality. Typically, under a buyback agreement the price for a new technology is much higher than in case of direct investments.
Original equipment manufacturer (OEM)
OEM can be considered as a form of subcontracting, where a local firm starts manufacturing
according to the foreign company specifications.
A foreign company transfers a part of its technologies and equipment. It conducts training and
management reorganization. Afterwards, the foreign company sells produced goods through its own
channels and under its own trademark.
OEM agreement enables local companies to absorb new technologies and to reorganize their
production. With new equipment and skills, these firms can produce new goods for the domestic
market under its own brand.
The main drawback of this agreement is the obligation to supply to the foreign company products at a
fixed price which is normally much lower than the market one.