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Personal collection and compilation of Dr Rajesh K Tiwari.

AMITY Institute of Biotechnology

AMITY University Lucknow Campus
________Uttar Pradesh_______

Prepareby: Dr Rajesh k Tiwari

Biosafty concerns of Transgenic

BIOSAFETY refers to policies and procedures adopted to ensure environmental

safety during the course of the development and commercialization of
transgenic organisms. Promotion of widespread use of transgenic crops is
suggested to have the following major risks.

• Escape of engineered genes by 'gene flow' or 'gene dispersal'

• Non-target effects or ecological effects

• Invasiveness or weediness of transgenics

• Creation of 'super-weeds' and 'super-viruses'
• Toxicity and allergenicity to human beings and animals
• Expression of undesirable phenotypic traits
• Erosion of biological diversity

It would be useful to go through some of the important elements of the

debate between the protagonists-and the critics of genetically modified
crops, particularly from the biosafety point of view.

Gene Flow or Dispersal from Transgenics:

Genetic traits that have selective advantages in agricultural or natural

systems are liable to spread beyond the cultivated variety in which they
were originally introduced. Creation of new weeds or increasing the
problems posed by existing weeds, due to transfer of modified genes by
hybridization or cross-pollination with uncultivated plants or wild relatives,
has been suggested as the primary risk in releasing transgenic plants .
The likelihood of the transgenes conferring herbicide tolerance, pest
resistance or disease resistance being transferred by cross-pollination to
sexually compatible species, and the possibility of producing persistent
weeds or invasive plant populations, have motivated researchers to study
pollen movement in various crops and also sexual compatibility among
crops and related species.

Inter-varietal gene flow (which occurs frequently, at least in allogamous

plants) and inter-specific gene flow (a much rarer event, occurring between
closely related species) are by no means limited to transgenic traits.
However, transgenic plants are considered as 'special cases' due to two
important reasons: (a) many transgenic characters correspond to ex nihilo
acquisition of one or several foreign genes, for which no equivalent
character would have appeared in the plant by spontaneous or induced
mutation; and (b) transgenic traits are dominant and monogenic, and may
thus be readily transmittable by out-crossing.


some of the important factors that may influence gene flow.

• Proximity of the transgenic with compatible wild relatives

• Sexual compatibility between crop plant and wild species or weed

• Mating system and mode of pollination
• Synchronization of flowering of crop and wild relative or weed
• Relative fitness of weed-crop hybrid
• Mode of seed dispersal
• Nature of transgenic character itself

The first five of the above were considered particularly important. However,
there is paucity of information on the occurrence of hybrid backcrossing
(believed to be a central step in introgression) and how different
transgenes may possibly influence gene flow to wild or weedy relatives.

There are, therefore, two fundamental questions to be addressed:

(a) whether gene flow can take place from transgenic to wild relatives or
weeds growing in the vicinity?

(b) whether hybrids derived from gene dispersal are capable of survival
and establishment?

Arguments that say 'Gene flow from transgenics can occur/

GENE FLOW AND DISTANCE. Although out-crossing frequency appears

to be strongly influenced by the distance of the recipient plant from the test
plot, but physical distance alone will be unlikely to prevent gene flow
between cultivated and wild populations of sunflower. Similarly transgenic
potatoes (Solanum tuberosum cv. Desiree), containing marker systems like
NPTII and GUS, indicated that gene dispersal could occur over long
distances and to a higher extent than had been previously shown.
Pollinator availability as well as the foraging distances of pollinators had
been suggested to be important.

Investigations by Ellstrand (1992), using cultivated radish (RaPhanus

sativus L.), which is out-crossing and insect pollinated, showed that gene
dispersal rates decreased markedly at greater distances, but some hybrids
containing marker gene could be found even 1km away. This study
emphasized that it is impossible to guarantee that a pollen grain will not
fertilize another plant at a greater distance, especially in out-crossing
species. Consequently, other strategies are required to prevent inter-
population mating and spread of modified genes.


(1993) studied crop/weed hybridization, heterosis and partial fertility of F1
crop/weed hybrids between grain chenopod (Chenopodium quinoa) and a
related wild species (c. berlanderi) native to North America. They suggested
that the breeding system by itself might not provide an accurate indication
of the potential for genetic interaction among predominantly self-pollinating
grain crops and their free living relatives.

A desk study by Kapteijns (1993) to assess the potential of various crop

plants to hybridize with wild flora in the Nether-lands indicated that maize
and potato are genetically isolated from wild flora, while beet and rapeseed
can potentially hybridize with wild relatives.

Lavigne and Gasquez (1992) showed that chlorsulfuron resistance could be

quickly dispersed by crossing resistant chicory (Cichorum sp.) with wild
chicory. Resistant weeds can be maintained in non-treated susceptible
populations. A recent study by a group of Danish scientists (Mikkelsen et al.,
1996) on canola plants genetically engineered for herbicide tolerance has
strongly indicated that genes from transgenic crops could establish quickly
in weedy populations.

Researchers who firmly believe that there is a strong opportunity for escape
of engineered genes feel that the key question about the release of
transgenic crops is not whether the transgenes will escape, but rather the
adaptive nature of genes themselves. They emphasize that the risk of
transgene escape via crop/congener hybridization must be considered when
releasing transgenics in countries where native populations of that crop
plant exist.

Argument that say “Transgenics pose little or no risk through gene flow

• Field trials with transgenic rapeseed (Brassica napus) with GUS,

kanamycin and asulam resistance markers at the Scottish Crop
Research Institute, Dundee, UK, on 80 wild and feral raspberry
populations, using a recessive marker gene spineless (s), and an
experiment on a tomato line containing the anthocyaninless (an) genetic
marker, have indicated the following:

(i) Limited gene dispersal may occur following large-scale gene

(ii) Gene flow events are probably infrequent and appear to be
strongly influenced by genotype of the immediately adjacent

(iii) Spread is localized for genes having probable selective neutral

value .

• A survey of literature has indicated that even when there is a possibility

of hybridization between Brassica napus and a related species growing in
the vicinity of a release by hand pollination or other methods, the hybrids
may exhibit poor vigour and high sterility and their progenies may not
survive in either agricultural or natural habitat.

• For some crop species such as potato, a number of barriers exist to

prevent natural hybridization and introgression with non-tuberous or
tuber-bearing Solanum species. The factors include geographical
distribution, endosperm imbalances, multiple ploidy levels and
incompatibility. The number and magnitude of these barriers makes
natural hybridization unlikely and transgene introgression impossible or
at least highly improbable.

• McPartlan and Dale (1994) provided evidence that the extent of gene
dispersal from transgenic to nontransgenic potatoes fall markedly with
increasing distance, and was negligible at 10 m. There was also no
evidence of transgene movement from potato to wild species, Solanum
dulcamara and S. nigrum, under field conditions.

Strategies to Prevent Gene Flow or Transgene Escape

Strategies suggested by some researchers to avoid the possible risk of

gene dispersal from transgenic plants include the following._

ISOLATION ZONE. An isolation zone devoid of vegetation discourages

gene flow from transgenic plants to wild or weedy
species or to other local cultivars. The isolation distance depends on the mode of reproduction (self-
/cross-pollination), and also the natural agents promoting cross-pollination (insects/wind etc.). There
are also established isolation distances for different crops, mainly used for seed production under
controlled conditions, that may be followed for experimental studies on gene flow; but, their utility
in farmers' fields is doubtful.

TRAP CROP. Use of trap crops, which are non-transgenic varieties of the same crop, planted
adjacent to the transgenic plot, can cleanse emigrating pollinators of transgenic pollen, thus
preventing gene flow. An experiment conducted by M/ s Calgene Ine. in California and Georgia with
transgenic canola/rapeseed (B. napus), using kanamycin resistance marker, showed that effectiveness
of the trap crop depends on the width of the isolation zone; gene escape was reduced when the two
varieties were separated by 8 m, but escape increased across a 4 m isolation zone.

MALE STERILITY. Introduction of male sterility so that engineered crops produce no pollen, or
pollen that is inactive, is another suggested mechanism to prevent gene flow from transgenic to
sexually compatible species through pollen. Linking of the engineered gene to a gene that is lethal in
pollen is a mechanism that can provide effective male sterility (Hernould et at., 1993) ..
OTHER STRATEGIES. Also proposed were strategies such as (i) removal of flowers from
transgenic plants, and (ii) removal of sexually compatible species. But, these manual strategies may
not find much applicability at a commercial level. A highly potential strategy that may be widely
applied in future to effectively circumvent the problem of gene flow is 'plastid transformation' or
'cWoroplast transformation', where the gene construct is introduced into chloroplasts and a selection
strategy is adopted that allows cells to retain only transformed chloroplasts (Maliga, 1993). This is in
contrast to 'nuclear transformation', which has so far led to development of various transgenic
varieties that have been commercialized. Since chloroplasts are inherited through cytoplasm, and
since pollen

from transgenic plants usually do not carry any significant cytoplasm,

there are negligible chances for 'transgene escape' or gene flow through
this strategy. However, due to technical difficulties associated with
chloroplast transformation, the strategy is yet to be exploited on a
commercial scale for development of transgenic cultivars in any crop
species. Recent reports indicate that some biotechnological companies
have succeeded in developing transgenic lines in important crops using
chloroplast transformation.

Gene Flow - Conclusions

For most weeds, we do not fully know the extent to which various
ecological factors limit their abundance, competitive ability or geographic
range. Over the long term, if gene flow occurs between transgenic crops
and weeds, certain weeds are likely to benefit from transgenes that confer
resistance to ecological factors such as herbivores, diseases or harsh-
growing conditions. Since our knowledge of many weeds is still limited, it is
difficult to predict possible problems that may be faced once transgenic
weeds are created. Ecological research can provide helpful information for
risk assessment of such a possibility.

It is also difficult to prevent gene flow between sexually compatible

species that hybridize spontaneously. But, cropweed or crop-wild species
hybridization is influenced by a variety of factors. Hence, it is important to
determine which kinds of novel traits introduced into transgenic crops might
be beneficial to wild or weedy relatives. For instance, gene flow from
herbicide-resistant transgenic crop to wild species or weeds may create
logistical and/or economical problems to farmers. Transgenes that confer
resistance to herbicides such as glyphosate or glufosinate may spread to
weedy crop relatives or to volunteers or feral crop plants, which mayor may
not be otherwise controlled by commonly used herbicides. Some
researchers fear that if such a situation arises, it may lead to application of
multiple types of alternative herbicides to control weeds.
Wherever the crop and the weed are different forms of the same species,
as in crops such as sunflower, squash and radish, crop-to-wild species/weed
gene flow can occur when these forms happen to grow nearby. Gene flow
can also possibly occur even when crops and weeds are distantly related; for
instance, between wheat (Triticum aestivum) and jointed goat grass (Aegilops
cylindrica), sorghum (Sorghum bicolor) andJohnson grass (Sorghum halepense) or
rapeseed (Brassica napus) and field mustard (Brassica rapa). In contrast, gene
flow from maize, cotton, soybean, potato and many other species is not
considered as a problem in the USA or Europe because wild or weedy
relatives of these crops do not occur nearby. However, the question of
commercialization of transgenic maize in countries like Mexico is being
intensively debated. For instance, considerable diversity exists in Mexico not
only for maize but also for a sexually compatible close relative of maize,
teosinte (Zea diPloperennis). Thus, the possibility of gene flow must be carefully
examined on a case-by-case basis in different geographic regions or

Biosafety of Antibiotic-resistance Markers

An important component of transgenic technology is the 'marker' gene,

which enables us to distinguish after transformation transgenic plants from
non-transgenic plants during the regeneration of seedlings in vitro, using a
simple procedure that does not involve advanced molecular techniques.
Genetically modified plants developed and commercialized so far commonly
contain selectable markers that confer resistance to antibiotics, herbicides or
drugs (discussed in chapter 2).

Concerns have been expressed widely about the biosafety of antibiotic

resistance markers that are commonly used during genetic transformation.
Some of the questions that have been raised in relation to biosafety
assessment of the marker genes are as follows .

• Are the products of marker genes, such as nptIL which confers kanamycin
resistance to the transgenic plant, toxic. to human and animal health?

• Can the plant or its products with antibiotic resistance be processed or

eaten by human beings and livestock without problems?

• Will the spread of the marker genes from genetically modified plants to
other living organisms in that . environment, be it plants through gene
flow or even bacteria through horizontal gene transfer, cause
unacceptable damage?

• Will the possible transfer of antibiotic-resistance genes from the crops to

the bacteria increase the level of such genes in the soil?

• Will antibiotic-resistance result in an undesirable increase in the use of


Several researchers tried to address the issue of biosafety of antibiotic-

resistance markers inserted in crop plants along with the gene(s) of
agronomic importance. Eady et at. (1993) and Gressel et at. (1992), based on
their studies on risk analysis of the marker genes, supported the concerns
that the protein products from transgenics might remain functional and
might have a physiological effect in animals, besides entering the food
chain as a pollen component. On the contrary, some research groups
(Flavell et at., 1992; Calgene Inc., 1990, 1991; Bryant and Leather, 1992;
Nap et at., 1992) have provided evidences to demonstrate that presence of
marker genes or their gene products in crop plants does not impose any
risk to human health or environment. Although studies have been carried
out on biosafety of NPTII, there are other selectable markers, the biosafety
of which is largely unknown. Some researchers express concern that this
can probably lead to risks.

The concerns about selectable markers, particularly antibiotic resistance

markers, have stimulated scientists in various countries to develop
alternative strategies. Efforts are being made by various research groups
towards (a) identification of new marker genes that can potentially replace
antibiotic resistance markers; (b) removal of antibiotic resistance marker
genes from current products; and (c) development of

strategies that can make use of a selectable marker gene till the
transformants are identified, followed by removal of selectable marker from
identified transformants.

Non- Target Effects

'Non-target effects' or 'unintended effects' or 'ecological effects' is

another important perceived risk, as transgenics are supposed to
undermine the ecosystem sustainability through direct or non-target effects
on microbial communities and soils or by encouraging agronomic practices
that are unsustainable.

Regulations in different countries generally require extensive analysis to

be carried out to determine whether proteins conferring resistance against
specific insect pests have any effect on non-target insect populations, or on
other organisms within the environment (Dale, 1995). For instance, before
the Bt-cotton, developed first by Mis Monsanto, was released for
commercial cultivation in 1996, an assessment of the safety to some non-
target organisms was established through studies on the receptor
specificity in target insects and the effects of Bt on non-target insects such
as· honey bees, green lacewing, ladybird beetle and parasitic wasp. These
studies showed that the non-target organisms were, in general, not
affected by Bt endotoxin; the same applied to birds, rodents and mammals.
A recent study carried out in the USA has, however, highlighted the
possible adverse effects of pollen from Bt-maize on the survival of larvae of
monarch butterflies. In a laboratory assay, Losey et al. (1999) have found
that larvae of monarch butterfly (Danaus Plexippus), reared on milkweed
leaves that were dusted with pollen from Bt-maize, grew slowly due to
relatively lower consumption, and suffered heavy mortality, in comparison
with the larvae reared on leaves dusted with maize pollen from non-
transgenic line or on leaves without any pollen. This study caused
considerable concern regarding conservation of monarch butterflies in the
USA, particularly in the 'Corn Belt', as the monarch larvae feed exclusively
on milkweed (Asclepias sp.), which is the primary host plant of monarch
butterflies in the northern United States and Canada. Milkweed frequently
occurs in and around the edges of the maize fields and a substantial
portion of available milkweeds may be within the range of maize pollen
deposition. Some researchers later questioned the implications of this
study, and the debate is still on.
Some ecologists contend that transgene-encoded products can
adversely affect soil fauna. Morra (1994) proposed that the overall impact
of transgenic plants will be dictated not only by primary gene product, but
also by secondary products resulting from abiotic and biotic soil reactions.
Primary and secondary products may exhibit acute as well as chronic
impacts. Tomlin (1994) suggested that testing of transgenic materials
should use similar protocols as conventional pesticides for comparing non-
target effects. Miller (1993) expressed concern that temporal expression of
pathogenesis- related proteins such as chitinase in transgenic plants might
cause non-target effects. He presented data to show a strong negative
association between To conclude, concerns about possible influence of
transgenics on non-target organisms may be valid, at least in some cases.
But, it is certainly difficult to satisfy all concerned about this issue, unless the
regulatory guidelines spell out clearly as to what ecological parameters can
be and should be effectively addressed by well-defined scientific studies, in a
given time-frame, for assessing the non-target or ecological effects of
transgenic crop plants.

'Weediness' or 'Invasiveness' of Transgenics

The general theory behind this concern is that genetic modification can
lead to crops with enhanced invasiveness, persistence or weediness.
'Invasiveness' or 'weediness' means tendency of the plant to spread beyond
the field where first planted, causing undesirable ecological changes. This
issue would seem particularly relevant to new crops or old crops introduced
into new areas. The classic example is 'kudzu', a plant which was introduced
into the southeastern United States to control soil erosion, and has -now
become a major invasive weed in the region (Cook, 2000).

For establishment and persistence of transgenic populations, some

workers (Raybould and Gray, 1993; Tomiuk and Loeschcke, 1993) have
identified certain conditions, such as dispersal and colonization rates, number
of introduced organisms, reproductive mode, effect of human interference,
pure chance and degree of niche overlap with resident species,
environmental variance in growth rate and maximum population size. No
general rules exist on the size of minimum viable populations for
establishment and persistence; numbers are specific to species and the
conditions of release.

On the basis of a study on British Impatiens sp., Williamson (1993) has

suggested that characters responsible for critical ecological behaviour are still
obscure and indicated a continuous spectrum of perceived weediness. Small
genetic changes can sometimes cause large ecological changes. Genetically
modified organisms will have characters new to that species' evolutionary
history. While most have little ecological effect, a few may be ecologically and
economically damaging. According to Wilkinson et at. (1993), transgenics may
possess a marked selective advantage and pose a greater risk of

In contrast, Crawley et at. (1993) have contended that transgenic lines are
less invasive and less persistent than their conventional counterparts. They
arrived at this conclusion through an experiment to assess whether genetic
engineering for herbicide tolerance affects the likelihood of rapeseed
Creation of 'Super-Weeds'
Herbicide resistance is currently one of the most successful as well as
highly controversial applications of agricultural biotechnology. A large
proportion of the transgenic varieties under commercial cultivation (see chapter
4) has herbicide resistance. Environmental organizations believe that weeds
will become more resistant through the use of new herbicide resistant
transgenic cultivars, and their commercialization, even otherwise, is not
consistent with sustainable agriculture (Bijman, 1994). Wrubel et at. (1993)
have expressed concern that farmers will apply high doses of herbicides over
several seasons, rather than limiting their use or using them in rotation with
other herbicides, thus increasing chances of development of herbicide-
resistant weeds. Hill (1991) also was of the opinion that crops engineered for
herbicide resistance might increase herbicide use.

Cereal farmers worldwide use sulfonylurea herbicide because of its

efficacy in small doses and its low toxicity. However, some sulfonylurea
products persist in soil for many years, severely limiting the options for crop
rotation. Field trials conducted by Alan McHughen and his colleagues at the
University of Saskatchewan, Canada, for three years on transgenic flax
plants, containing an Arabidopsis acetolact;ate synthase gene, provided a
positive view of the herbicide-resistant plants (McHughen and Holm, 1991). A
farmer in Saskatchewan, for instance, with soil of neutral pH, has to wait 34
months after applying metasulfuron methyl before seeding flax. The possible
options are to grow cereals continuously or to leave the land fallow over
summer. Farmers can avoid such undesirable practices if they are able to
include in their rotation one crop that is capable of growing in soil containing
residual herbicide. Also, they may well be able to reduce their overall use of
chemicals to combat weeds. The Saskatoon group had

reported that plants could be grown in soils with high residual levels of
sulfonylurea, and there was no yield penalty in the presence or absence of
herbicides. Dixon (1995) also argued that transgenic plants will require less
chemical use than nontransgenic plants, and that use of herbicide-resistant
plants will lead to more sustainable agronomic practices when used in
commercial farming.

"Vhile potential benefits can be envisioned of herbicideresistant crops,

the success and environmental benefits of these crops are greatly
dependent on the ways they are promoted by companies and used by
farmers. In agriculture, there is generally a choice of herbicides for weed
control. But, thought needs to be given to advisability of introducing several
different herbicide-resistance genes into the same crop species (Caseley et
at., 1991). It may be interesting to note that there are many conventionally
bred varieties that are resistant to specific herbicides; so the prospect of
gene flow of this type is not unique to transgenic varieties. However, it
cannot be concluded, at present, that herbicidetolerant crops pose no
greater threat to environment than the conventional, as most of the risk
evaluation experiments have dealt with only glufosinate, and other
herbicides evoke resistance with different mechanisms. Hill (1991) and
Gressel et at. (1992) emphasized the need for a case-by-case approach as
herbicide resistance may be safe in one location but riskier in another, as
the prospect of gene flow leading to creation of super-weeds is also largely
influenced by the prevalence of sexually-compatible wild species and their
weedy relatives in a location where a transgenic variety is grown.

Creation of 'Super-Viruses'
There is a fear expressed that new virulent virus strains may emerge
from using virus-resistant transgenics, basically through two mechanisms -
heteroencapsidation and recombination.

HETEROENCAPSIDATION. There is a greater perceived risk of

interactions occurring between the products of a viral transgene and an
unrelated superinfecting virus through

heteroencapsidation. In plants engineered with viral coat proteins,

heteroencapsidation of closely related viruses can occur and this can affect
transmission frequencies. Before embarking on large-scale use of coat
proteins in transgenic plants, it is argued that a search should be
conducted for umbraviruses (which require encapsidation by a helper
virus), that might spread using engineered protein.

The risk of heteroencapsidation is refuted by some workers (Hull et al.

1994). Interactions that might result in heteroencapsidation rarely occur in
natural joint infections, and thus are unlikely in transgenic situations. As the
coat protein region, which determines vector specificity, is not important for
protection against viruses in transgenic plants, vectors which do not pose a
risk of such interactions can be designed (Hull et al., 1994).
Heteroencapsidation with transgenic plants would occur only slightly above
the existing background of natural events, and its significance in viral
spread has not been fully understood.

RECOMBINATION. In transgenic viruses, recombination can occur either

by copy choice or cleavage and ligation. This may cause increases in
pathogenicity, although there are very few known cases. RNA
recombination could also take place between the transcribed transgene
and an infecting virus (Greene and Allison, 1994). Evidence about
recombination between different viruses has not been collected, but
phylogenetic studies of plant RNA virus evolution indicate that
recombination is common, and some of the new viruses could survive.
Some virologists do not support the above view. Falk and Bruening (1994)
argued that recombination could take place in the field between viruses
with different host ranges during mixed infections, but new viruses did not
appear to be the result. The need for selection pressure to promote
recombination is noted. The frequency of recombination between transgene
RNA and viral genomic RNA is unlikely to be higher than that occurring
naturally between viral genomic RNAs; and the viability of any new virus is
unlikely to be higher than that of existing viruses throughout the infection
cycle. Recombination between distinct viruses is less likely to create
pathogens than between similar ones. Tabei et al. (1994) also concluded
that the influence of transgenic melon plants, with resistance against
cucumber mosaic virus, on the environment was not different from that of
normal plants. While technical solutions can be proposed for some of the
potential problems such as heteroencapsidation, Tepfer (1993) concluded
that information available about the effectiveness of viral control genes in
the field is too meagre for a conclusive risk-benefit analysis.

Food Safety

Biotechnology has extensive applications in improving nutritional quality

and of food crops providing substitutes for traditional food products. The
scope for modifying food supply is particularly immense, as there is no
need for the parents to cross-breed (Ellahi, 1994). The significance and
possible impact of biotechnology on value-addition of food products are
now well recognized. For instance, genetic engineering has tremendous
potential to improve oil quality of food crops. Edible vegetable oils often
require extensive chemical modification to increase their utility, such as
increased oleic acid content, decreased linolenic acid content, and
increased or decreased fatty acid content (Kinney, 1994). Transgenic
varieties with improvements in nutritional quality are expected to be
commercialized on a larger scale in several countries than is at present.
The safety of food products, derived from transgenic varieties, to human
and animal health is another issue that is being widely debated. Food
safety is perhaps a more complex scientific issue than biosafety. The
applications of biotechnology to food processing and production have
implications for the safety and quality of the food supply. When plants are
genetically engineered to enhance food quality, functionality or processing
or handling characteristics of food products, appropriate measures need to
be taken to ensure that desirable attributes such as nutritional quality are
not inadvertently diminished, and that naturally occurring toxicants are not
unknowingly increased.

Concerns have been particularly raised about the safety of food

products derived from the Bt transgenic crops. Krattiger and Raman (1996),
in a review on Bt technology, have reported that Bt insecticidal protein is not
harmful to mammals, birds or fish, or to most beneficial insects. Mammals,
including humans, do not have d-endotoxin receptors in their guts and all Bt
proteins tested so far degrade within 20 seconds in the presence of
mammalian digestive juices.

Some workers have suggested that if a new food or food component is

substantially equivalent to an existing food or food component, it can be
treated in the same manner with respect to safety, as no additional safety
concerns would be expected. Where substantial equivalence is more
difficult to establish because the food or food component is less wellknown
or new, then the identified differences should be the focus of further safety
considerations. However, in our opinion, to ensure public acceptance of
genetic engineering technology, regulatory agencies should proceed with
caution and carry out rigourous scientific studies on the food safety of
transgenics on a case-by-case basis.

ALLERGENICITY. Another major concern related to food safety is the

possibility of generation of allergens, toxins and irritants in food products
from transgenics. The draft on biosafety released by the Edmonds Institute
(1996) proposed several ways in which allergens, toxins and irritants may
be generated through genetic engineering of crop plants. However,
according to some reports, only a small proportion of the human population
(1-2%) suffer from food allergies induced by immunological reactions to
foods such as eggs, milk, fish, shellfish, groundnut (peanut), soybean,
wheat and tree nuts. All food allergens are proteinaceous in nature, but
most proteins do not elicit any allergenic effects on adults or children.
In case of food products obtained using modern

In conclusion, a series of studies in recent years have served to point

out important issues that have to be paid due attention during development
and commercialization of transgenic crops, particularly from the point of
view of environmental and food safety. Consumers are particularly
concerned about the food safety of products derived from genetically
modified crops. While many concerns expressed about biosafety of
transgenics are indeed valid, some may be misplaced. There are strong
arguments voiced by researchers and concerned individuals in support or
against the applications of crop biotechnology. It is well recognized that the
only way to resolve various issues related to biosafety is to generate
adequate, reliable and relevant scientific information about possible
benefits and potential hazards of a transgenic, through rigourous
evaluations under controlled conditions, before commercialization of a
transgenic is authorized by concerned authorities. Hence, regulations and
risk assessment have become an integral part of transgenic technology.
Biosecurity of transgenic Bt technology

In the context of modern agricultural biotechnology the term biosecurity has two components,
biosafety, the safety of genetically engineered (GE) organisms and/or their products to humans and
animals as food, feed and medicine; and environmental safety, the safety of non-target organisms,
soil and water. The terms biosecurity and biosafety are often used incorrectly as synonyms.
Biosecurity issues raised to oppose GE crops by anti-tech activists are relevant even to products of
classical agricultural biotechnology, but were never made an issue in that context.
It was the international scientific community, not the anti-tech activists, who have identified the
possible biosecurity risks from the transgenic crops and devised testing and mitigation protocols.
Science has reasonable peer reviewed experimental evidence to answer biosecurity concerns. The
regulatory process in every country ensures that all questions are answered reasonably satisfactorily
before commercialization is permitted. Most of those who raise biosecurity issues to voice their
opposition to GE crops have no locus standi in terms of scientific knowledge and expertise to trash
the combined global scientific wisdom.

Biosafety of Bt
Bt being a universally occurring soil bacterium, all species of plants and animals in agricultural and
other situations, and those that use plants as food have been exposed to Bt and Bt proteins for
centuries. Bt proteins are transient in the environment, the toxicity of Bt proteins is pest specific,
dependent upon a set of biological pre-requisites. The use of Bt as a conventional pesticide for over
60 years has demonstrated that it is safe to a variety of non-target organisms. Cry proteins were
shown to be harmless to vertebrates, including mammals and humans, even at high doses, by
ingestion, inhalation or injection.

Toxicity and allergenicity

Anti-tech activists raise issue after issue to brand GE crops as toxic. Reports of the death of
peacocks and the death of farm animals in Andhra Pradesh and honey bee colony collapse disaster
in Europe and North America, were attributed to the presumed toxicity of Bt proteins in GE crops.
These incidents projected as major issues have been effectively shown to be due to causes other
than Bt protein toxicity. Several claims have been made of allergenicity of transgenic crops, including
Bt cotton in some places in India, but there has never been any scientific evidence.

Impact of Bt on non-target organisms

The much-brandished instance of toxicity of Bt proteins to non-target organisms was based on the
study by Losey, et al., (Nature, 1999) who reported that transgenic Bt corn pollen harm monarch
larvae, a conclusion immediately questioned by Hodgson
(Nature Biotechnology, 1999). Subsequently, Sears, et al., (2001) re-examined the issue, avoiding
the flaws in the experimental design in the study of Losey et al., and concluded that impact of Bt corn
pollen on monarch butterfly populations was not significant.
A February 2008 publication indicates that Cry 1Ab Bt proteins do not affect the performance of
bumble bees in any manner. In May 2008 Bt Cry1C proteins were shown to be safe to parasitoids
that control pest populations in many crops, in contrast to the severe damage caused to the
parasitoids by the traditional insecticides.

How safe are Bt transgenics?

All the evidence indicates that Bt transgenics are very safe and over a decade’s cultivation of Bt
transgenics has neither confirmed the scary scenarios aired by the critics nor has thrown up any new
threats. Biosecurity issues are unfortunately often mixed up with political, economic, management,
societal and ethical issues, emotionalizing and sensationalizing the concerns, to spread fear and
suspicion of GE technology.