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Chapter 1


Modern biotechnology has allowed the movement of genetic material across
unrelated species, something impossible with the traditional breeding methods.
This intentional transfer of genetic material has in turn brought biotechnology out
from the laboratory to the field. Genetically modified organisms (GMOs) are
organisms whose genetic material has been artificially modified to change their
characteristics in some way or another.1 In essence, genetic modification or
genetic engineering techniques enable scientists to find individual genes that
control particular characteristics, separate them from the original source, and
transfer them directly into the cells of an animal, plant, bacterium, or virus. This
technology has many potential applications.2
However, when introduced into the environment, they could have
unintended environmental consequences and may play more pronounced
ecological roles than the wild types . Genetically improved microorganisms are
able to reproduce and establish themselves as persistent populations and may have
subtle and long-term effects on biological communities and natural ecosystems .
1 C. James, Preview: global status of commercialized Biotech/GM crops, 2006
2 L. Alberghina, L. Frontali, and P. Sensi, Proceedings of the 6th European Congress on
Biotechnology, Elsevier Science Publishers, Amsterdam, The Netherlands, 1994.

Results of DNA modification may not be limited only to the particular

characteristics of the replaced gene. It is therefore important to ensure that when
these organisms are released into nature they do not harm the environment or
human health. Such concerns have led to broader interests in the theme of risk
assessment in the release of GMOs. A cautious approach is necessary to assess
environmental risks which may occur due to introduction of recombinant
organisms in the natural environment. 14
The surge in popularity, along with the controversy surrounding them, has
prompted regulators in the United States and around the world to define what
constitutes a GMO & LMO. For centuries, farmers have used breeding to modify
the genetics of plants, searching for ways to improve traits that include yield,
disease resistance and flavor. Some of those breeding techniques, including wide
cross breeding and mutagenizing seeds using radiation or chemicals, involved
years of laboratory tinkering but are not considered GMOs and LMOs.
Advancements in biotechnology over recent decades have given breeders the
ability to exert greater and more precise control over the breeding process.


2.1 Genetically modified organism:

A genetically modified organism (GMO) is any organism whose genetic material
has been altered using genetic engineering techniques (i.e., a genetically
engineered organism). GMOs are the source of medicines and genetically
modified foods and are widely used in scientific research and to produce other
goods. The term GMO is very close to the technical legal term, 'living modified
organism', defined in the Cartagena Protocol on Biosafety, which regulates
international trade in living GMOs (specifically, "any living organism that
possesses a novel combination of genetic material obtained through the use of
modern biotechnology. A more specifically defined type of GMO is a "transgenic
organism." This is an organism whose genetic makeup has been altered by the
addition of genetic material from an unrelated organism. This should not be
confused with the more general way in which "GMO" is used to classify
genetically altered organisms, as typically GMOs are organisms whose genetic
makeup has been altered without the addition of genetic material from an
unrelated organism.
Genetic modification involves the mutation, insertion, or deletion of genes.
Inserted genes usually come from a different species in a form of horizontal genetransfer. In nature this can occur when exogenous DNA penetrates the cell
membrane for any reason. This can be accomplished artificially by:

attaching the genes to a virus.

physically inserting the extra DNA into the nucleus of the intended host
with a very small syringe.3

using electroporation (that is, introducing DNA from one organism into the
cell of another by use of an electric pulse).

firing small particles from a gene gun.4

Modern genetic engineering began in 1972 when United States Biochemists

Herbert Boyer and Stanley Cohen used enzymes to cut a bacteria plasmid and
insert another strand of DNA in the gap. Both bits of DNA were from the same
type of bacteria, but this milestone, the invention of Recombinant DNA
technology, offered a window into the previously impossible the mixing of traits
between totally dissimilar organisms.

2.2 Living modified organism (LMO):

Living modified organism (LMO) is , any living organism that possesses a novel
combination of genetic material obtained through the use of modern
In general use the term living modified organism (LMO) is considered to be
functionally the same as genetically modified organism (GMO).6

3 Cornell Chronicle, 14 May 1987, page 3. Biologists invent gun for

shooting cells with DNA
4 Stanford, Journal of Particulate Science and Technology
5 The Cartagena Protocol on Biosafety 2000

In general usage, LMOs are considered to be the same as GMOs . Many countries
use the terms genetically modified organism, genetically engineered organism,
and transgenic organism in domestic legislation to describe LMOs . During the
negotiations of the Cartagena Protocol, EU member countries accepted the LMO
definition in the negotiated text and interpreted this definition to be in accordance
with the definition of a GMO in the EU Directive . Both terms can therefore be
used interchangeably.
LMOs form the basis of a range of products and agricultural commodities.
Processed products containing dead modified organisms or non-living GMO
components include certain vaccines; drugs; food additives; and many processed,
canned, and preserved foods. They can also include corn and soybean derivatives
used in many foods and nonfoods, cornstarch used for cardboard and adhesives,
fuel ethanol for gasoline, vitamins, vaccines and pharmaceuticals, and yeast-based
foods such as beer and bread.

6 Secretariat of the Convention on Biological Diversity (CBD

Secretariat) 2013

Chapter 3
3.1 International Instruments For LMOs and GMOs:
Two international instruments changed the playing field in the past decade
regarding the international regulation of genetically engineered organisms. One is
the Cartagena Protocol on Biosafety 2000 , which is intended to regulate the
international transfer of "living modified organisms" (LMOs). The second is a set
of guidelines, the Risk Analysis Principles for Foods Derived from Biotechnology,
established by a little-known United Nations body called the Codex Alimentarius
Commission. These two instruments signal attempts by the world community to
establish rules governing the production, trade and use of genetically modified
foodstuffs. Both agreements emphasize the rights of consumers and farmers, and
the protection of ecosystems. However, it is still not completely clear how their
provisions will work alongside the free-trade rules of the World Trade
Organization (WTO).

3.2 The Cartagena Protocol on Biosafety 2003:

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is

an international agreement on biosafety as a supplement to the Convention on
Biological Diversity effective since 2003. The Biosafety Protocol seeks to protect
biological diversity from the potential risks posed by genetically modified
organisms resulting from modern biotechnology.
The Biosafety Protocol makes clear that products from new technologies
must be based on the precautionary principle and allow developing nations to
balance public health against economic benefits. It will for example let countries
ban imports of genetically modified organisms if they feel there is not enough
scientific evidence that the product is safe and requires exporters to label
shipments containing genetically altered commodities such as corn or cotton.
In accordance with the precautionary approach, contained in Principle 15 of
the Rio Declaration on Environment and Development, the objective of the
Protocol is to contribute to ensuring an adequate level of protection in the field of
the safe transfer, handling and use of 'living modified organisms resulting from
modern biotechnology' that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to human
health, and specifically focusing on transboundary movements.

3.2.1 Overview of features:

The Protocol promotes biosafety by establishing rules and procedures for the safe
transfer, handling, and use of LMOs, with specific focus on transboundary
movements of LMOs. It features a set of procedures including one for LMOs that
are to be intentionally introduced into the environment called the advance
informed agreement procedure, and one for LMOs that are intended to be used
directly as food or feed or for processing. Parties to the Protocol must ensure that
LMOs are handled, packaged and transported under conditions of safety.
Furthermore, the shipment of LMOs subject to transboundary movement must be
accompanied by appropriate documentation specifying, among other things,

identity of LMOs and contact point for further information. These procedures and
requirements are designed to provide importing Parties with the necessary
information needed for making informed decisions about whether or not to accept
LMO imports and for handling them in a safe manner.
The Party of import makes its decisions in accordance with scientifically
sound risk assessments. The Protocol sets out principles and methodologies on
how to conduct a risk assessment. In case of insufficient relevant scientific
information and knowledge, the Party of import may use precaution in making
their decisions on import. Parties may also take into account, consistent with their
international obligations, socio-economic considerations in reaching decisions on
import of LMOs.Parties must also adopt measures for managing any risks
identified by the risk assessment, and they must take necessary steps in the event
of accidental release of LMOs. To facilitate its implementation, the Protocol
establishes a Biosafety Clearing-House for Parties to exchange information, and
contains a number of important provisions, including capacity-building, a
financial mechanism, compliance procedures, and requirements for public
awareness and participation.

3.2.2 Pecautionary Approach:

One of the outcomes of the United Nations Conference on Environment and
Development (also known as the Earth Summit) held in Rio de Janeiro, Brazil, in
June 1992, was the adoption of the Rio Declaration on Environment and
Development, which contains 27 principles to underpin sustainable development.
Commonly known as the precautionary principle, Principle 15 states that "In order
to protect the environment, the precautionary approach shall be widely applied by
States according to their capabilities. Where there are threats of serious or
irreversible damage, lack of full scientific certainty shall not be used as a reason
for postponing cost-effective measures to prevent environmental degradation."

Elements of the precautionary approach are reflected in a number of the

provisions of the Protocol, such as:

The preamble, reaffirming "the precautionary approach contained in

Principle 15 of the Rio Declaration on environment and Development";

Article 1, indicating that the objective of the Protocol is "in accordance

with the precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development";

Article 10.6 and 11.8, which states "Lack of scientific certainty due to
insufficient relevant scientific information and knowledge regarding the extent
of the potential adverse effects of an LMO on biodiversity, taking into account
risks to human health, shall not prevent a Party of import from taking a
decision, as appropriate, with regard to the import of the LMO in question, in
order to avoid or minimize such potential adverse effects."; and

Annex III on risk assessment, which notes that "Lack of scientific

knowledge or scientific consensus should not necessarily be interpreted as
indicating a particular level of risk, an absence of risk, or an acceptable risk."

3.2.3 Advance Informed Agreement:

The "Advance Informed Agreement" (AIA) procedure applies to the first
intentional transboundary movement of LMOs for intentional introduction into the
environment of the Party of import. It includes four components: notification by
the Party of export or the exporter, acknowledgment of receipt of notification by
the Party of import, the decision procedure, and opportunity for review of
decisions. The purpose of this procedure is to ensure that importing countries have
both the opportunity and the capacity to assess risks that may be associated with
the LMO before agreeing to its import. The Party of import must indicate the
reasons on which its decisions are based (unless consent is unconditional). A Party

of import may, at any time, in light of new scientific information, review and
change a decision. A Party of export or a notifier may also request the Party of
import to review its decisions.
However, the Protocol's AIA procedure does not apply to certain categories
of LMOs:

LMOs in transit;

LMOs destined for contained use;

LMOs intended for direct use as food or feed or for processing

While the Protocol's AIA procedure does not apply to certain categories of LMOs,
Parties have the right to regulate the importation on the basis of domestic
legislation. There are also allowances in the Protocol to declare certain LMOs
exempt from application of the AIA procedure.

3.2 The Codex Alimentarius: focus on food safety:

Two months before the Protocol entered into force, a separate breakthrough took
place. In July 2003, with the backing of all its 168 member nations, the Codex
Alimentarius Commission produced the first set of international guidelines for
assessing and managing any health risks posed by GM foods.
A relatively obscure United Nations agency, the Commission is charged with
the key global task of setting international guidelines for food quality and safety. It
was established in 1963 by the Food and Agriculture Organization (FAO) and the
World Health Organization (WHO), and given the mandate of "protecting the
health of the consumers and ensuring fair practices in the food trade". The
Commission draws up voluntary international food guidelines through
negotiations in approximately 30 committees and task forces.


The most significant element of the 2003 guidelines is that they call for
safety assessments of all GM foods prior to their approval for commercial sale.
This has important implications for WTO members. In 1995, the WTO had agreed
that Codex norms should be the reference point for evaluating the legitimacy of
food regulatory measures that are challenged as restrictions on trade. Thus,
although the Codex guidelines are strictly voluntary, they have legal significance
for WTO members as a defense to charges of "unfair trade." Also significant is
that all of the major countries growing GMOsthe US, Canada, Argentina, and
Australiaare Codex members and agreed to these risk assessment guidelines.
The Codex risk assessment guidelines contain much language about the need
for a "scientific" evaluation of the actual hazards presented by the new foods. But
they also recommend that "risk managers should take into account the
uncertainties identified in the risk assessment and implement appropriate
measures to manage these uncertainties". This wording appears to acknowledge
the validity of a precautionary regulatory regime, similar to that allowed for
international shipments under the Cartagena Protocol.
The Codex also recognizes that "Other Legitimate Factors"non-scientific
in nature can form a valid basis for regulations, such as using halal or kosher
standards. Other provisions within the guidelines call for a "transparent" safety
assessment, that should be communicated to "all interested parties" that have
opportunities to participate in "interactive" and "responsive consultative
processes" where their views are "sought" by the regulators.
These non-scientific aspects are consistent with the second prong of the
Codex mandate, namely its role in deterring deceptive practices. Such practices
might, for example, include selling or distributing GM foods to consumers
without labeling them as such. As a top world food exporter, the United States has
vigorously advocated that only "objective" and "scientific" health claims be used
as the basis for regulating GMO foods, but consumer groups have vigorously
contested this position. In the summer of 2011, after 18 years of struggle, Codex


finally adopted a guidance document recognizing that countries can adopt laws
and regulations covering the labeling of GE foods, including mandatory labeling.

Chapter 4

4.1 Biosafety Rules 2012:

Previously there were no special laws regulating biotechnology, biosafety and
GMOs in Bangladesh even though the country ratified the Cartagena Protocol on
biosafety (makes provisions to regulate, manage or control risks associated with
transfer, handling and use of GMOs/LMOs and products thereof that may have
adverse effects on conservation and sustainable use of biological diversity). In
2012 Government has passed The Bio-Safety Rule, in exercising rules making
power delegated under Section 20 of the Bangladesh Environment Conservation
Act, 1995. With passing this Rule, GMOs are no more unregulated in Bangladesh.
Rule no. 3 imposes restrictions on import and export of GMOs as 'no person
or institution can import, export, buy, sell or commercially use the Genetically


Modified Organism and products thereof, without prior permission from the
Ministry of Environment and Forest'. This Rules also provides for mandatory
provision for identification or labeling of GMOs in rule 5 as 'any box or cover,
which carries Genetically Modified Organism or Products thereof, shall have
detail identification or labeling on it relating to the nature of Genetically Modified
Organism or products thereof, which is additional provision, notwithstanding
anything contained in any other law regarding this'. This Rules criminalised
adverse impacts of GMOs as 'environmental pollution and damaging the
ecosystem' in the following words 'if any environmental pollution is created or
ecosystem is damaged by the Genetically Modified Organism or Products thereof,
the producer institution, exporter, importer, store keeper, supplier and retailer, all
shall be liable for the offence of environmental pollution or ecosystem damage,
unless he/they proves that he/they does not have direct involvement with such
pollution or damage'

4.2 Biosafety Guidline 2007

In respect of biosafety related to GMOs, Bangladesh has also developed a Biosafety Guideline in 2007, which is endorsed by the Bio-safety Rules. The
Guidelines of 2007 formed the basis of the regulatory framework of monitoring
and enforcement processes in respect to biosafety in Bangladesh and it also
structured the institutional frameworks. This Guideline provides different








responsibilities. Biosafety guidelines are applicable to all research and

development activities of modern biotechnology conducted in laboratories of the
government research institutes, state enterprises, universities, international
organisations located in Bangladesh, private companies or non-governmental
organisations etc.
Biosafety guidelines are applicable to all research and development activities
of modern biotechnology conducted in laboratories of the government research


institutes, state enterprises, universities, international organisations located in

Bangladesh, private companies or non-governmental organisations etc.
In accordance with the mandate of National Bio-Safety guidline 2007, the
Government of Bangladesh is now framing a National Bio-safety Policy and a
GMO Enforcement Manual. As regards the laws of Bangladesh non-compliance is
the main problem. These legal provisions should be monitored properly and
enforced strictly, so that no one can take advantage of the weak regulatory
mechanism of biosafety in Bangladesh

Chapter 5

The application of genetic modification allows genetic material to be transferred

from any species into plants or other organisms. The introduction of a gene into
different cells can result in different outcomes, and the overall pattern of gene
expression can be altered by the introduction of a single gene. The sequence of the
gene and its role in the donor organism may have a relatively well-characterized
function in the organism from which it is isolated. However, this apparent
precision in the understanding of a gene does not mean that the consequences of
the transfer are known or can be predicted . Copies of a gene may be integrated,
additional fragments inserted, and gene sequences rearranged and deletedwhich
may result in lack of operation of the genes instability or interference with other
gene functions possibly cause some potential risks [16]. Therefore, there could be
a number of predictable and unpredictable risks related to release of GMOs in the


open environment. The report prepared by the Law Centre of IUCN, the World
Conservation Union (2004), enlists numerous environmental risks likely to occur
by the use of GMOs in the field. These risks are as follows.
Each gene may control several different traits in a single organism. Even the
insertion of a single gene can impact the entire genome of the host resulting in
unintended side effects, all of which may not be recognizable at the same time. It
is difficult to predict this type of risk.
1. Genetic Contamination/Interbreeding
Introduced GMOs may interbreed with the wild-type or sexually compatible
relatives. The novel trait may disappear in wild types unless it confers a selective
advantage to the recipient. However, tolerance abilities of wild types may also
develop, thus altering the native species ecological relationship and behaviour.
2. Competition with Natural Species
Faster growth of GMOs can enable them to have a competitive advantage over the
native organisms. This may allow them to become invasive, to spread into new
habitats, and cause ecological and economic damage.
3. Increased Selection Pressure on Target and Nontarget Organisms
Pressure may increase on target and nontarget species to adapt to the introduced
changes as if to a geological change or a natural selection pressure causing them
to evolve distinct resistant populations.
4. Ecosystem Impacts
The effects of changes in a single species may extend well beyond to the
ecosystem. Single impacts are always joined by the risk of ecosystem damage and
5. Impossibility of Followup


Once the GMOs have been introduced into the environment and some problems
arise, it is impossible to eliminate them. Many of these risks are identical to those
incurred with regards to the introduction of naturally or conventionally bred
species. But still this does not suggest that GMOs are safe or beneficial, nor that
they should be less scrutinized.
6. Horizontal Transfer of Recombinant Genes to Other Microorganisms
One risk of particular concern relating to GMOs is the risk of horizontal gene
transfer (HGT). HGT is the acquisition of foreign genes (via transformation,
transduction, and conjugation) by organisms in a variety of environmental
situations. It occurs especially in response to changing environments and provides
organisms, especially prokaryotes, with access to genes other than those that can
be inherited .HGT of an introduced gene from a GMO may confer a novel trait in
another organism, which could be a source of potential harm to the health of
people or the environment. For example, the transfer of antibiotic resistance genes
to a pathogen has the potential to compromise human or animal therapy . HGT has
been observed for many different bacteria, for many genes, and in many different
environments. It would therefore be a mistake to suppose that recombinant genes
would not spread to other bacteria, unless precautions are taken. Recent evidence
from the HGT technology confirms that transgenic DNA in GM crops and
products can spread by being taken up directly by viruses and bacteria as well as
plant and animals cells. Very recently, Yoshida et al. reported that HGT also
moved from a nuclear monocot gene into the genome of the eudicot parasite
witchweed, which infects many grass species in Africa.


Chapter 6

6.1 Concluding Remarks:

The use of genetically modified organisms is important in order to meet increasing
demands and improve existing conditions prevalent in our environment. We are at
an anxious juncture where, on one hand, we are faced with unprecedented threats
to human health and environment, while on the other hand we have opportunities
to change the way things are done. Regulations concerning use of GMOs need a
broader basis for decision. Postrelease impacts of GMOs can follow preventive
and precautionary measures based on risk assessment and management.
Monitoring and detection methods are vital for risk assessment and management
to control the negative environmental and health impacts. The international
biosafety regulatory frameworks are sufficiently stringent in order to protect
against genuine ascertainable risks, as well as the ability of decision makers to
discern the appropriateness of data necessary to adequately conduct a risk


assessment, which all have considerable consequences. Consideration of social,

economic, and ethical issues needs to be taken care of. Application of the
precautionary approach provides avenues for future development and use of
genetic engineering.

1. D. Schubert, A different perspective on GM food,Nature

2. Colin Andre Carter, Giancarlo Moschini,GeneticallyModifiedFoodand
GlobalWelfare EmeraldGroupPublishing,2001