Biotechnology & Biotechnological Equipment

ISSN: 1310-2818 (Print) 1314-3530 (Online) Journal homepage: http://www.tandfonline.com/loi/tbeq20

Biosafety Regulations of GMOS: National and

International Aspects and Regional Cooperation

N. Alexandrova, K. Georgieva & A. Atanassov

To cite this article: N. Alexandrova, K. Georgieva & A. Atanassov (2005) Biosafety Regulations
of GMOS: National and International Aspects and Regional Cooperation, Biotechnology &
Biotechnological Equipment, 19:sup3, 153-172, DOI: 10.1080/13102818.2005.10817294

To link to this article: https://doi.org/10.1080/13102818.2005.10817294

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BIOSAFETY REGULATIONS OF GMOS: NATIONAL
AND INTERNATIONAL ASPECTS AND REGIONAL
COOPERATION
N. Alexandrova, K. Georgieva, A. Atanassov
AgroBioInstitute, Sofia, Bulgaria
Introduction
Well-known biotechnology processes such
as fermentations have been applied for
more than 5000 years. Nowadays biotech-
nology, which covers the application of
tissue culturing, gene transfer, immuno-
logical techniques, molecular genetics and
recombinant DNA techniques, is indubita-
bly the most rapidly developing branch of
biological science. Properly applied, agri-
cultural applications of modern biotechno-
logy have a significant potential to contri-
bute to sustainable gains in agricultural
productivity and to reduce poverty and en-
hance food security in developing regions.
Recent advances in molecular techniques
have provided plant breeders with the un-
precedented ability to introduce new traits
into plants that could not have been ac-
complished through traditional cross-
breeding Biotechnology is also recognized
as a powerful tool that, if properly focused,
can offer new solutions for a number of old
challenges in agriculture, the environment,
and human and animal health. Like any
new technology with considerable potential
for changes in the gene pool of a specific
crop, genetic modification technology
voiced some concerns for its application in
agriculture and medicine.
Genetically modified organisms (GMOs)
are organisms, produced by transferring,
very often of one gene encoding a desirable
trait, in one organism to another, through
precise molecular biology technique, called
genetic modification (in comparison with
20th Anniversary AgroBioInstitute - R&D 153
the classical breeding, in which an uncon-
trolled transfer of more than one genes oc-
curs and many of the genes have unidenti-
fied effect on the resulting organism).
GMOs appeared for the first time on the
market in USA in 1994 According to the
latest statistics, the global area with com-
mercially grown transgenic plants is 81.0
million ha by 8.25 millions of farmers from
17 countries on 6 continents. (9). It is
worth to notice that 90% of the beneficiary
farmers are resource- poor farmers from
developing countries, whose increased
incomes from biotech crops contributed to
the alleviation of the poverty. The global
market value of GM crops is estimated to
4.70 billion USD that represents 16% of
the global seed market. The global value of
the biotech market is projected at more
than 5 billion USD for 2005, which
ambiguously shows the considerable
economical benefit of the modern biotech-
nologies.
Notwithstanding the great potential for
benefits that this technology could bring to
the environment and society, there is a
common understanding within the commu-
nity at large that a balanced and compre-
hensive approach of biosafety is needed for
evaluating the possible adverse effects
from the deliberate release of biotech pro-
ducts into the environment, as well as their
use in human and animal diets.
Biosafety of GMOs is a rapidly deve-
loping multidisciplinary approach that en-
compasses science, ethics and societal is-
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
sues, policy and regulatory frameworks that
assess and manage risks for human and
animal health (including food and feed
safety), and risks for environment associ-
ated with the development and application
of the products of modern biotechnologies.
Biosafety is a holistic concept of direct
relevance to the sustainability of agricul-
ture, food safety, and the protection of the
environment, including biodiversity. After
the entering into force of the Cartagena
Protocol on Biosafety on 11th of September
2003 there is an urgent need for acquiring
specific information and capacity-building
in this area for further implementation of
biosafety policy and taking informed deci-
sions by governments at national, regional
and international level.
Epochal changes have been brought
about by globalization, the increasing role
of the private sector in third world agricul-
tural economies, and the development and
introduction of genetically modified (GM)
organisms coupled with the possibility of
introducing alien species, genotypes and
plant pests into the environment. These
changes justify the need for developing
biosafety frameworks at national level as
well as harmonized international instru-
ments and guidelines.
In 1992 an the United Nations Confe-
rence on Environment and Development,
also known as the Earth Summit, was held
in Rio de Janeiro in Brazil. At this confe-
rence, 172 Governments agreed on several
documents among which were Agenda 21
and the Convention on Biological Diver-
sity.
Chapter 16 of Agenda 21 deals with the
environmentally sound management of
biotechnology and recognizes two impor-
tant facts: 1) although not a panacea, mo-
dern biotechnology promises significant
contributions to sustainable food produc-
tion, improved health care and environ-
mental protection, and 2) the community at
large can only then benefit maximally from
the potential of modern biotechnology, if it
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
is developed judiciously and adequate
safety mechanisms are in set place. With
this context, Agenda 21 provides a blue
print for international collaboration for the
further development and application of
biotechnology and biosafety.
Another key agreement adopted at the
Earth Summit in Rio was the Convention
on Biological Diversity. The objectives of
the Convention are the conservation of
biological diversity, the sustainable use of
its components and the fair and equitable
sharing of the benefits arising out of the
utilization of genetic resources. In 2000,
the Cartagena Protocol on biosafety, estab-
lished under The Convention of Biological
Diversity, has been adopted. It aims at
regulating the transboundary movement of
living modified organisms (LMO) resulting
from modern biotechnology in light of
protecting biological diversity from poten-
tial risks that may be posed by the LMOs.
The aim of this study is to provide with
an overview of the most relevant to bio-
safety regulations of GMOs international
instruments. Further, some examples of
national biosafety frameworks will be pre-
sented. The legal aspects of Bulgarian bio-
safety framework will be highlighted to-
gether with a discussion about the possible
impacts on science and society. An attempt
to identify the needs and areas of syner-
gism and harmonization in the field of bio-
safety on an international and regional level
will be made.
International agreements
Convention on Biological Diversity
(CBD)
One of the major international instruments
relevant to biosecurity is the Convention on
Biological Diversity (1992) and its Carta-
gena Protocol on Biosafety (2000). The
scope of the Convention and its objectives
are the conservation of biological diversity,
the sustainable use of its components and
the fair and equitable sharing of the bene-
fits arising out of the utilization of genetic
154 20th Anniversary AgroBioInstitute - R&D
resources.
While most of the measures outlined in
the CBD tend to protect species in an indi-
rect way by focusing on the conservation of
ecosystems, one aspect concerning the con-
servation of biological diversity is to be
highlighted within the context of this study:
the management of risks associated with
living modified organisms (LMO’s) re-
sulting from biotechnology (11).
The CBD addresses biosafety in two arti-
cles: Article 8(g) and Article 19(3) and (4).
Article 8(g) requires each Party “…to ma-
nage or control the risks associated with the
use and release of living modified orga-
nisms resulting from biotechnology which
are likely to have adverse environmental
impacts that could affect the conservation
and sustainable use of biological diversity”.
In this Article the Convention goes even
beyond its general scope requiring to take
also into account the risks to human health.
Environmental impact assessment and
minimizing adverse impact on biological
diversity are relevant obligations (art. 14.1
(a)). These also include reciprocity, notifi-
cation, exchange of information with other
States and international organizations
where activities in one party may adversely
affect the biodiversity of another party or
an area beyond the limits of any national
jurisdiction (art. 14(1)(c and d)). Parties are
to create emergency response arrangements
at national level and joint contingency
plans with other States (art. 14(1)(e)). The
Conference of the Parties of the CBD was
required to consider under Article 19(3) the
need for a biosafety protocol which now
provides the basis for international mea-
sures related to the trade in LMOs.
Whether it ratifies or accedes to the Proto-
col or not, a CBD Party must still fulfill its
obligations to implement CBD Article 8(g).
In addition, where it does not ratify or ac-
cede to the protocol, a CBD Party still
needs to implement CBD Article 19(4). (7)
Article 19(4) creates a bilateral obliga-
tion for a CBD party to provide informa-
20th Anniversary AgroBioInstitute - R&D 155
tion on the use and handling of LMOs prior
to providing such organisms to another
CBD party. This information includes (1)
any available information on the regulatory
measures taken by the exporting CBD
Party and (2) any available information on
the “potential adverse impact” of a par-
ticular LMO.
The Convention is non-self-executing in
that it requires implementing legislation. In
fact, its implementation occurs largely at
the national level and is the responsibility
of each individual Contracting Party. The
official documents that guide Contracting
Parties in their implementation of the Con-
vention are the Articles of the Convention
and the Decisions of the Conferences of the
Parties. Under Article 26, Contracting Par-
ties are required to report periodically on
the implementation of the Convention.
Cartagena Protocol on Biosafety to the
Convention on Biological Diversity
The Protocol is was adopted in 2000 and
entered into force by September, 2003. It is
the first global legally binding instrument
focusing on LMOs.
The purpose of the Protocol is to ensure
adequate levels of protection in the field of
safe transfer, handling and use of LMOs
resulting from modern biotechnology that
may have adverse effects on the conserva-
tion and sustainable use of biodiversity or
pose a risk to human health (art. 1; art. 4).
The Protocol is applicable to all LMOs
apart from those that are pharmaceuticals
for humans that are addressed by other in-
ternational agreements (art. 5).Relevant
provisions are arts. 6 to 10 and art. 12 es-
tablishing an Advance Informed Agree-
ment (AIA) which requires, prior to the
first intentional introduction into the envi-
ronment of an importing party, a) a notifi-
cation of the party of export containing
certain information, b) the acknowledge-
ment of its receipt and c) the written con-
sent of the party of import. Criteria are
provided for decision making on importa-
tion; in particular, they must be according
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
to a risk assessment.
The AIA procedure only applies to those
LMO’s intended for intentional introduc-
tion into the environment. According to the
Protocol AIA does not refer to living modi-
fied organisms intended for direct use as
food, feed or processing. Other exceptions
are LMOs identified in a decision of the
COP as not likely to have adverse effects
on biodiversity conservation and sustain-
able use; LMOs in transit; and LMOs for
contained use.
For LMOs that may be subject to trans-
boundary movement for direct use as food
or feed, or for processing, art. 11 provides
that a Party that makes a final decision for
domestic use, including placing on the
market, must notify the Biosafety Clearing-
House created under the Protocol. In addi-
tion, certain information must be provided.
Art. 11(4) permits parties to take an import
decision under its domestic regulatory
framework, provided this is consistent with
the Protocol. A developing country con-
tracting Party, or a Party with economy in
transition, that lacks a domestic regulatory
framework, can declare through the Bio-
safety Clearing House that its decision on
the first import of an LMO for direct use as
food, feed or for processing will be pursu-
ant to a risk assessment (art. 11(6)). In both
cases lack of scientific certainty due to in-
sufficient relevant scientific information
and knowledge regarding the extent of po-
tential adverse effects shall not prevent the
contracting Party of import from taking a
decision, as appropriate, in order to avoid
or minimise potential adverse effects (art.
11(8)). (7)
The precautionary principle is well re-
flected into this article. This principle was
enshrined at the 1992 Rio Conference on
the Environment and Development, during
which the Rio Declaration was adopted,
whose principle 15 states that: “in order to
protect the environment, the precautionary
approach shall be widely applied by States
according to their capability. Where there
Biotechnol. & Biotechnol. Eq. 19/2005 156
Special Issue
are threats of serious or irreversible da-
mage, lack of full scientific certainty shall
not be used as a reason for postponing
cost-effective measures to prevent envi-
ronmental degradation”. In 2000, at the
COP of the CBD, the Protocol confirmed
the key function of the Precautionary Prin-
ciple (Annex II of the Protocol).Of interest
for its potential implication with trade re-
striction is art. 2 (4) pursuant to which each
party can take more protective action to
conserve and sustainably use biodiversity,
provided action is consistent with the Pro-
tocol. (6, 2)
The Protocol provides risk assessment
guidelines in Annex III. The risk assess-
ment must be undertaken in a manner
which is scientifically sound and transpa-
rent and on a case-by-case basis. The lack
of scientific knowledge or scientific con-
sensus should not necessarily be interpreted
as indicating a particular level of risk, an
absence of risk or an acceptable risk.
The Protocol specifies general risk man-
agement measures and criteria. Any mea-
sures based on risk assessment should be
proportionate to the risks identified (i.e., to
the extent necessary to prevent adverse
effects within the Party of import) (art.
16(2)). Measures to minimise the likeli-
hood of unintentional transboundary
movement of LMOs are to be taken (art.
16(3)). Affected or potentially affected
States are to be notified when an occur-
rence may lead to an unintentional trans-
boundary movement (art. 17(1)).
During the Protocol negotiations, there
was a debate on the extent to which socio-
economic considerations should be consi-
dered in risk assessment. The Protocol
states that contracting parties reaching im-
port decisions under the Protocol or under
domestic legal measures implementing the
Protocol may account for socio-economic
considerations arising from the impact of
LMOs on biodiversity conservation and
sustainable use (especially with regard to
the value of biodiversity to indigenous and
20th Anniversary AgroBioInstitute - R&D
local communities) (art. 26(1)). The text of
the article practically provides for the pos-
sibility both adverse effects and benefits
rising from the use of LMOs to be taken
into account, when they relate to biodiver-
sity issues. The parties are encouraged to
co-operate on research and information
exchange on any socio-economic impacts
of LMOs, especially on indigenous and
local communities (art. 26(2)). It is inte-
resting to note the interface with WTO on
this matter, considering that SPS says
nothing on the subject (13).
The meeting of the parties is to consider
the need to develop standards on identifi-
cation, handling, packaging and transport
practices in consultation with other relevant
bodies.
WTO-SPS Agreement
The WTO oversees the implementation
of the Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS
Agreement). The SPS Agreement provides
for a common approach to different sectors
in the context of biosafety by applying to
all sanitary and phytosanitary measures
(SPMs), which may directly or indirectly
affect international trade (art. 1). The SPS
Agreement, while permitting governments
to maintain appropriate sanitary and phyto-
sanitary protection, reduces possible arbi-
trariness of decisions and encourages con-
sistent decision-making. A member State’s
SPMs: (1) must only be applied to the ex-
tent necessary, (2) be based on scientific
principles and (3) must not be maintained
without sufficient scientific evidence (art.
2(2)). SPMs must also not “arbitrarily or
unjustifiably discriminate between member
States” and SPMs cannot be applied in a
manner that would constitute a disguised
restriction on international trade (art. 2(3)).
The Agreement requires that sanitary and
phytosanitary measures be applied for no
other purpose than that of ensuring food
safety and animal and plant health. In par-
ticular the Agreement clarifies which fac-
tors should be taken into account in the
20th Anniversary AgroBioInstitute - R&D 157
assessment of the risk involved. Measures
to ensure food safety and to protect the
health of animals and plants should be
based as far as possible on the analysis and
assessment of objective and accurate sci-
entific data.
Risk assessment techniques developed by
relevant international organizations must be
taken into account. Risks are to be assessed
taking into account a number of enume-
rated factors including “available scientific
evidence” (art. 5 (2)). Member States can
also take “relevant economic factors” into
account when assessing the risk, and es-
tablishing risk management measures (i.e.
establishing the appropriate level of pro-
tection manifested by an SPM), (3).
The SPS Agreement provides some
flexibility for member States to adopt
SPMs provisionally when scientific evi-
dence for the measures is insufficient (art.
5(7)). Provisional SPMs can be adopted on
the basis of “available pertinent informa-
tion” derived from a variety of sources.
However, member States must subse-
quently seek additional information to
more objectively assess the risk and to re-
view the SPM within a reasonable period
of time (7).
Governments are required to notify other
countries of any new or changed sanitary
and phytosanitary requirements which af-
fect trade, and to set up offices (called
“Enquiry Points”) to respond to requests
for more information on new and existing
measures (Annex B para 3). They also
must open to scrutiny how they apply their
food safety and animal and plant health
regulations. The systematic communication
and information and exchange of experi-
ences among the WTO’s member govern-
ments provide a better basis for national
standards. They also protect the interest of
consumers, as well as of trading partners.
This Agreement is another example of a
non-self-executing legal instrument. In fact,
Members have to revise their regulations in
order to comply with international stan-
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
dards. Furthermore, according to Art. 13,
Members shall formulate and implement
positive measures and mechanisms in sup-
port of the observance of the provisions of
the Agreement by other than central go-
vernment bodies.
WTO-TBT Agreement
The WTO also oversees the implementa-
tion of the Agreement on Technical Barri-
ers to Trade (TBT Agreement). The
Agreement tries to ensure that regulations,
standards, testing and certification proce-
dures do not create unnecessary obstacles.
The WTO’s version is a modification of the
code negotiated in the 1973-79 Tokyo
Round.
The TBT Agreement may be of relevance
to biosafety also for its relevance to bio-
technology products because it generally
applies to technical regulations and stan-
dards, including packaging, marking and
labelling requirements. There are thus also
implications for GMOs in standard setting
under the TBT.
The TBT Agreement applies to all pro-
ducts (art. 1.3). It does not apply to sanitary
and phytosanitary measures (art. 1.5).
Therefore, the SPS Agreement would apply
where a biotechnological product may be a
risk to human, plant or animal health. The
TBT Agreement would apply where, for
example, a product is merely labeled as
containing GMOs. In general, imported
products are to be accorded national treat-
ment (art. 2.1). Technical regulations
should not create unnecessary obstacles to
international trade and should not be more
trade-restrictive than necessary to fulfill a
“legitimate objective, taking account of the
risks of non-fulfillment” (art. 2.2). Legiti-
mate objectives include inter alia prevent-
ing deceptive trade practices, protecting
human health or safety, animal or plant life
or health, or the environment.
A contribution to harmonization within
the Agreement is the development of inter-
national standards. When member States
impose technical regulations they are to be
Biotechnol. & Biotechnol. Eq. 19/2005 158
Special Issue
based on international standards to the ex-
tent that this would be effective (art. 2.4).
Codex Alimetarius
In the food safety area, the Codex Alimen-
tarius is the primary collection of interna-
tionally adopted food standards and as such
is of great relevance to biosafety. The Co-
dex has become the seminal global refe-
rence point for consumers, food producers
and processors, national food control agen-
cies and the international food trade. Both
Codex subsidiary bodies and the Commis-
sion, an intergovernmental body develo-
ping and keeping under review the Codex,
give the highest priority to consumer inte-
rests in the formulation of commodity and
general standards. The adopted format for
standards reflects the emphasis that Codex
places on ensuring that consumers receive
products that are of a minimum acceptable
quality, are safe and do not present a health
hazard (Garrett, 2002).
The Codex Commission is also the pri-
mary forum in which the food safety as-
pects of GMOs are addressed. Food con-
sisting of GMOs or LMOs is a type of
“novel food” that is covered by the Codex.
Six instruments are relevant, of which the
Codex Guidelines for the Production,
Processing, Labelling and Marketing of
Organically Produced Food; the Principles
for the Risk Analysis of Foods Derived
from Modern Biotechnology; the Guideline
for the Conduct of Food Safety Assessment
of Foods Derived from Recombinant DNA
Plants and the Codex Alimentarius Pro-
posed Revised Code of Ethics for Interna-
tional Trade in Food have been adopted.
Instrument still being developed is the Pro-
posed Draft Guidelines for the Labelling of
Foods Obtained Through Certain Tech-
niques of Genetic Modification/Genetic
Engineering. In addition, in the animal feed
area, the Codex Commission is developing
a proposed Code of Practice on Animal
Feeding aimed at establishing a feed safety
system that covers the whole “‘feed chain’
from farm to table”. This will eliminate
20th Anniversary AgroBioInstitute - R&D
potential risks to human health, animal
health and the environment. It will apply to
the production and use of all materials of
animal, plant and marine origin used in
animal feed at all levels, whether produced
industrially or on the farm.
International Plant Protection
Convention (IPPC)
The IPPC came into force in 1952 and has
been amended once in 1979 and again in
1997. The IPPC regulates plant pests. It
also regulates “any organism, object or
material capable of harbouring pests or
spreading pests that affect plants or plant
products” (art. I(4)). The purpose of regu-
lation is to prevent “the spread and intro-
duction of these pests and promoting
measures for their control” (ICPM, 2001a).
IPPC application to plants is not limited
only to the protection of cultivated plants
or direct damage from pests. The scope of
the Convention extends to the protection of
cultivated and natural flora as well as plant
products, and includes both direct and indi-
rect damage by pests. “Pest” is broadly
defined in the Convention as “any species,
strain or biotype, animal life or any patho-
genic agent injurious or potentially injuri-
ous to plants or plant products”. Alien or-
ganisms that come within this definition are
covered. The IPPC’s scope of application
is broad enough to include genetically
modified organisms, or living modified
organisms/products of modern biotechno-
logy that may directly or indirectly damage
plants. There is potential for overlap with
the CBD and with the Cartagena Protocol,
which is why cooperation is growing bet-
ween the two agreements.
Convention on access to information,
public participation in decision-making
and access to justice in environmental
matters
The Convention on access to information,
public participation in decision-making and
access to justice in environmental has been
adopted in 1998 in Aarhus, Denmark and it
is also known as Aarhus Convention. The
20th Anniversary AgroBioInstitute - R&D 159
objective of the convention is to contribute
to the protection of the right of every per-
son of present and future generations to
live in an environment adequate to his or
her health and well-being, each Party shall
guarantee the rights of access to informa-
tion, public participation in decision-ma-
king, and access to justice in environmental
matters in accordance with the provisions
of this Convention. It lays down basic rules
to promote citizens’ involvement in envi-
ronmental matters and enforcement of en-
vironmental law. As such, it deals with de-
cisions relating to significant undertaking
that have potential to impact environment
e.g. dams, nuclear power plants, hydroe-
lectric plants etc. Originally, the Conven-
tion did not deal with GMOs. On the Se-
cond meeting of the Parties to the Conven-
tion in Almaty, Kazakhstan in May, 2005
the Parties have agreed to extend the pu-
blic’s legal right to participate in decision-
making on the release and placing on the
market of genetically modified organisms
(GMOs).
The Parties agreed to an amendment to
the Convention whereby the public would
have the right to submit comments and the
public authorities would be expected to
take these into account in the decision
making process. Such decisions, except
those that require commercial confidentia-
lity, should be publicly available including
reasons and considerations for them.
National regulations and
legislation
According to the increasing economical
importance of biotechnology products, de-
veloped and developing countries have
instituted biosafety policies and procedures
to ensure their safe use. These protective
measures are implemented though estab-
lishing biosafety systems that provide a
mechanism for making informed decisions.
For these regulatory systems to function
successfully and effectively, they should be
flexible to adapt amenably to the evolution
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
of scientific knowledge, to ensure feedback
mechanisms and to reflect the conditions of
a given country as much as possible.
This issue is examined by choosing ex-
amples of diverse biosecurity frameworks,
from both industrialised and developing
countries, which reflect different ap-
proaches to the regulatory and legislative
set-ups. These include developing new
laws for dealing with biotechnological en-
vironmental and health issues, adapting the
existing legislative system to the novel re-
quirements, or adopting a regulation system
based on guidelines rather than on laws.
Argentina
Agencies within the Agricultural Directo-
rate of the Secretariat of Agriculture, Live-
stock, Fisheries, and Food (SAGPyA)
regulate the use of biotechnology and its
products. The major entities are the Na-
tional Advisory Commission on Agricul-
tural Biotechnology (CONABIA), the Na-
tional Institute of Seeds (INASE), and the
National Agrifood Health and Quality
Service (SENASA). In addition, the Na-
tional Directorate of Agrifood Markets
(DNMA) plays a role in the commerciali-
zation of GMOs.
CONABIA is a multidisciplinary inter-
institutional advisory group responsible for
evaluating scientific and technical issues
associated with the potential environmental
impact of GMOs. It reviews requests for
environmental releases and prepares re-
commendations for the Secretary of Agri-
culture to issue corresponding permits. The
Commission was created in 1991 by
Resolution No. 124/91 of the former Sec-
retariat of Agriculture, Livestock and Fi-
sheries.
SENASA is the agency within SAGPyA
entrusted with the mandate to regulate food
safety and quality, animal health products
and pesticides. Regulatory authority is
granted under Law 18284 of the Argentine
Food Codex and three decrees.
INASE is the SAGPyA agency in charge
of registering and controlling commercially
Biotechnol. & Biotechnol. Eq. 19/2005 160
Special Issue
marketed seeds. Transgenic varieties are
treated similarly to new hybrids since they
are submitted to the same performance tests
as non-GMOs.
Resolution 289/97 establishes that a fur-
ther requirement for the commercialization
of GMOs comes under the DNMA. The
agency's mandate assesses the possible im-
pact of commercializing a given product on
the country's international trade.
Pharmaceuticals and other human health-
related products obtained through biotech-
nological methods are regulated by the Na-
tional Administration of Drugs, Food and
Medical Technologies (ANMAT), an
agency within the Ministry of Health.
ANMAT is supported by the National Ad-
visory Committee for Biotechnology and
Health (CONBYSA).
The particularity of the Argentine bio-
safety system is its flexibility, that it, it is
based on guidelines rather than on legisla-
tion, which allows for changes to reflect
the advancement of scientific understan-
ding. On the other hand, the prosecution of
non-compliance cases are legally restricted.
A biosafety law that carries penalties for its
violation is being prepared (12).
Australia
Through various regulatory agencies, the
Federal Government monitors the use of
gene technology. The main regulators are:
• Food Standards Australia New Zealand
(formerly ANZFA), supported by the
Australia New Zealand Food Authority
Act (1991), to develop and maintain laws
and systems that ensure food safety and
regulate food labelling in Australia and
New Zealand.
• The Office of the Gene Technology
Regulator (OGTR) manages any poten-
tial risks associated with gene techno-
logy, ensures coordinated regulation, and
makes certain that any safeguards set in
place are comprehensive.
• The Australian Competition and Con-
sumer Commission (ACCC) administers
the Trade Practices Act (1974) and the
20th Anniversary AgroBioInstitute - R&D
 Prices Surveillance Act (1983) to protect
consumers from unfair trading, and false,
misleading, and deceptive conduct.
• The Australian Quarantine and Inspection
Service (AQIS) develops policies and
procedures relating to incoming passen-
gers, mail, animals and plants that have
quarantine significance. This includes
genetically manipulated products impor-
ted into Australia that may pose a pest
and disease risk.
• The National Occupational Health and
Safety Commission (NOHSC) is respon-
sible for encouraging community aware-
ness and developing policies and strate-
gies for occupational health and safety.
Specifically, the NOHSC is responsible
for assessing industrial chemicals.
• National Registration Authority (NRA) is
responsible for the system that evaluates,
registers and regulates agricultural and
veterinary chemicals.
• The Therapeutic Goods Administration
(TGA) is responsible for administrating
provisions of the Therapeutic Goods Act
(1989), which provides a national
framework for the regulation of thera-
peutic goods in Australia to ensure their
quality, safety and efficacy. Genetically
manipulated pharmaceuticals are ad-
dressed under this system (14).
Canada
In line with a similar approach adopted in
the United States, the regulatory framework
established in Canada is based on the ex-
tension of the existing regulations to
GMOs. In Canada, the GM products are
regulated on the basis of the expressed
traits and not on the method used to intro-
duce the traits. Thus, the Canadian regula-
tion system considers organisms with novel
traits that can be produced by conventional
breeding, mutagenesis or recombinant
DNA techniques.
A GM product may undergo assessment
by several agencies, among which the Ca-
nadian Food Inspection Agency (CFIA)
plays the leading role. CFIA is directly re-
20th Anniversary AgroBioInstitute - R&D 161
sponsible for any necessary field trials for
crop plants, and for approving any GM
feed for animals. Particularly, CFIA is re-
sponsible for regulating GM plants, as-
sessing their impact on the environment
and biodiversity, and examining the possi-
bility of gene flow and impact on non-tar-
get organisms. It is also in charge of en-
suring livestock feed safety, including feed
composition, toxicology, nutrition and die-
tary exposure.
Health Canada, on the other hand, is re-
sponsible for assessing food safety. Many
GM crops are destined, in whole or in spe-
cific parts, for the human food supply sys-
tem. For this reason, they are not only must
obtain CFIA approval, but must also be
assessed by Health Canada. It is within the
jurisdiction of Health Canada to regulate
GM foods according to the Food and Drugs
Act and Regulations under the Novel Food
Regulations.
The CFIA operates under the authority of
the Seed Act, the Plant Protection Act, the
Feeds Act, the Fertilizer Act, and the
Health of Animals Act. It also shares some
responsibilities with Environment Canada
under the Canadian Environmental Protec-
tion Act, and with Health Canada under the
Pest Control Products Act, and the Food
and Drug Act. The Canadian Environ-
mental Protection Act is umbrella legisla-
tion apparently intended to serve as a
regulatory "safety net" for any biotech-
nological products not currently regulated
by another federal act.
The Department of Fisheries and Oceans
regulates aquatic organisms under the Fi-
sheries Act, although it has not yet adopted
specific regulations that address GM or-
ganisms.
The current regulations established by
the Canadian Food Inspection Agency
foresee compulsory labelling only for
products that could involve potential dan-
gers to human health (i.e. allergenicity) or
whenever the GM-derived product presents
significant nutritional differences from its
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
non-GM counterpart (4).
The European Union
The EU legislative framework covers dif-
ferent field of activities such as, inter alia,
agriculture, environment, food and plant
safety. In the context of this study, analysis
has focused on the legislation covering: the
release of GMOs into the environment and
commercialization; the direct use of living
modified organisms as food or feed, or for
processing; the transboundary movement of
GMOs and GM microorganisms in order to
give a broad spectrum of different fields of
relevance to biosafety.
Within the European Union (EU) the
primarily regulation regarding the use of
GMOs is Directive 2001/18/EC. As re-
gards the previous Directive 90/220/CEE,
it contains new measures and defines more
precisely the procedures for the environ-
mental release of GMOs for both experi-
mental and commercial purposes. In par-
ticular, it provides for:
- the application of a precautionary ap-
proach;
- a case by case evaluation of the environ-
mental risk deriving from the release of
GMOs, also considering long-term ef-
fects;
- consultation with the ethical and scientific
committees from Member States;
- transparency and public accessibility to
information related to the release of
GMOs;
- institutions of public registers containing
the information on genetic modification
of GMOs;
- introduction of monitoring improved risk
management and labelling;
- approval of the environmental release for
no longer than 10 years;
- a procedure for approval renewal;
- an institution of public register containing
a list of the location of the GMOs re-
leases for either experimentation or
commercialization; and
- elimination of antibiotic resistance genes
acting as transformation markers (by
Biotechnol. & Biotechnol. Eq. 19/2005 162
Special Issue
2004 for commercial releases and by
2008 for research).
Another Directive (98/81/CE) aims at
regulating the confined use of GM micro-
organisms, while the regulation 1946/2003
regarding transboundary movement of
GMOs is harmonised with the Cartagena
Protocol on biosafety.
New directives on labelling and trace-
ability 1830/2003 and on GM food and
feed 1829/2003 have been prepared. The
EU legislation establishes a threshold for
the percentage content (0.9%) of GM mate-
rial above which foods must be labelled as
containing or being produced from a GMO.
Below that level, it does not have to be la-
belled, provided that the GM content is of
constructs that have been authorised for use
in EU and can be shown to be adventitious
and technically unavoidable. There was
previously no tolerance threshold for the
adventitious presence in food and feed of
GM material that has not been authorised
in EU. The new food and feed regulation
provides that there should be a threshold of
0.5% for the adventitious presence pro-
vided that the material has received a fa-
vourable risk assessment and the operator
can demonstrate that its presence was tech-
nically unavoidable. This threshold how-
ever can only be enforced where it is pos-
sible to test for the presence of the material
in question. The new legislation extends
the current labelling provisions to all food
and feed produced from GMOs, even if
they are analytically equivalent to those
derived from non-GMO sources and thus
no foreign DNA or protein can be detected
in the final product (10).
South Africa
South Africa is the first country in Africa
that has adopted a specific legislation to
regulate the development, use and release
of GMOs through the South African Ge-
netically Modified Organisms Act of May
1997. This legal instrument is applied to
GMOs per sé and to their development,
release and commercial use. The responsi-
20th Anniversary AgroBioInstitute - R&D
ble authority is the Department for Agri-
culture and the main controlling organ is
the Executive Council, comprising repre-
sentatives of the Departments of Agricul-
ture, Science and Technology, Environ-
ment, Health, Labour and Industry. The
Council is also the authority that approves
the environmental releases of GMOs, while
the management of the requests and opera-
tions is delegated to a Register. The Re-
gister releases the authorizations, nomi-
nates inspectors and implements the con-
trols foreseen by the Act. The Executive
Council is assisted by a Scientific Com-
mittee composed of eight scientists who are
experts on issues involving GMOs. Their
task is to provide scientific and technical
guidance to the Council (and, if required,
to the Department of Agriculture) relating
to issues such as environmental impact, and
the confined use, export and import of
GMOs.
Through regulations adopted in Novem-
ber 1989, the South African Genetically
Modified Organisms Act foresees the need
for authorization based on specific risk as-
sessment for any import, export, develop-
ment or commercial use of GMOs, with the
exception of the confined use of some spe-
cific organisms within academic or re-
search institutions. Any request for inten-
tional environmental release has to be sub-
mitted to the Executive Council and needs
to be accompanied by a public notice, pub-
lished in at least three daily newspapers
from the region where the release is
planned to take place. To date, the reports
on risk assessment are not available for
public consultation (17).
USA
Since 1987, the US Administration has set
up a regulatory framework for the agro-
alimentary applications of biotechnology.
The following three governmental agencies
are involved in this framework: the Animal
and Plant Health Protection Inspection
Service (APHIS) of the Department of Ag-
riculture, the Environmental Protection
20th Anniversary AgroBioInstitute - R&D
Agency (EPA) and the Food and Drug
Administration (FDA). APHIS is in charge
of overlooking the field trials and issues the
relevant authorizations for the environ-
mental release of GMOs based on the ex-
perimental data provided by the applicant.
In principle, APHIS’ experts operate two
inspections in the experimental fields. It
issues authorizations on the grounds that
the concerned GMO is not fundamentally
distinct from its non-GMO counterpart. It
shows that it is the final product rather than
the technology employed that requires
regulation. It claims that the said regulation
should be a function of the final use of the
concerned GMO and should be based, if
necessary, on a case by case analysis.
The procedure requires the applicant
prior to the field trials to prepare a request
that maps out the process through which
the concerned GMO is obtained and its
relevant characteristics. Within 100 days
from the receipt of the application, the
APHIS must make a decision, although the
indication of the other two relevant
authorities, the Environment Protection
Agency and the Food and Drug Admini-
stration, are also necessary for GMO com-
mercialization.
The EPA is the responsible authority for
the development, commercialization, dis-
tribution and assessment of pesticides and
defines the residual limits of these pesti-
cides in crops. It plays a major role in the
assessment of GMOs, classifying those that
are pest- or insect-resistant among vegetal
pesticides. On the other hand, the FDA is
in charge of the assessment of GM food
safety and considers genetic markers as
food additives. The FDA bases its safety
analysis on the assessment of the plant’s
agronomic and qualitative characteristics,
on the type of genetic modification and on
the stability of the characteristics con-
cerned. It also considers the potential to-
xicity and allergenicity of the protein(s)
introduced in the genetic modification of
the original plant. At present, based on the
163 Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
principle of substantial equivalence, the
FDA has indicated that there is no need to
impose labelling for products derived from
GMOs (8).
Regulation costs
The requirements of setting up regulations
and legislative systems on the safe use of
biotechnological products indubitably in-
volve additional costs. Examples of ele-
ments that add costs to the process could be
as follows:
• Setting up a national regulatory frame-
work and, in some cases, a strong de-
mand for harmonization at the national
level among the institutions dealing with
the regulatory issues;
• Additional funding for human resources
involved in this process;
• Risk Assessment (RA) and Risk Ma-
nagement (RM): costs for equipping
laboratories for RA and risk analysis;
building facilities for containment and
implementing the appropriate RM strate-
gies;
• Funding for subsequent monitoring and
surveillance;
• Labelling costs;
• Capacity-building (administrative, scien-
tific, information-sharing and public
awareness).
These elements are especially relevant
and innovative for developing counties and
those with economics in transition. Even
when forming regulatory frameworks by
adapting regulatory guidance already im-
plemented elsewhere, cost sharing still car-
ries a financial burden. The variety and
disparity of potential frameworks call for
normalization of both information require-
ments and relative stringency of regulatory
oversight. There are other costs for bio-
safety training, data collection and storage
and monitoring programmes. International
guidelines (e.g. Codex Alimentarius)
and/or a binding protocol under the Con-
vention on Biological Diversity may assist
in the harmonization process while pro-
viding an overall umbrella for biosafety
Biotechnol. & Biotechnol. Eq. 19/2005 164
Special Issue
regulatory programmes. Programmes that
create networks on regional and sub-re-
gional levels may facilitate the acquisition
and dissemination of biosafety expertise at
reduced costs. Providing useful, relevant
information is a worthwhile task, but it can
be expensive. With unique issues to ad-
dress, developing countries may find li-
mited use for existing assessments done
elsewhere (15).
The financial burden of regulation costs
could be reduced substantially by non-
regulation or de-regulation of the process
of introducing biotech products. However,
although organic farming has been identi-
fied as an alternative to the biotechnology-
based agriculture, it is also shown to pose
regulatory costs (5).
GMO regulations in Bulgaria
The GMO law that treats the control of the
genetically modified organisms (GMOs),
which recently entered into force since
June 2005, provoked significant interest in
the media and the whole society in Bul-
garia. Because of its multidisciplinary fea-
ture (the law considers agricultural, envi-
ronmental, health, trade, high-tech and in
particular biotech-issues) and scientific
specificity however, many aspects of its
nature have been left apart from the aware-
ness of the broad pubic. This law however
has an enormous economical, social and
scientific importance for Bulgaria while it
has the potential to contribute to positio-
ning Bulgaria among the countries with
high developed technologies and economi-
cal prosperity or, in contrast, at the rear of
Europe and the developing world.
One year after the first commercialization
of a transgenic plant in 1994 (FLAVR-
SAVR tomato), Bulgaria signed an agree-
ment with EU, which paved the way of the
negotiations for EU accession. In this line,
the country was strongly encouraged to
harmonize its legislation with that in place
in EU.
On March, 15th 2005, the Bulgarian Pa-
20th Anniversary AgroBioInstitute - R&D
rliament adopted a GMO law that imple-
ments EC Directives 2001/18 on deliberate
release and placing on the market of
GMOs, 90/219/ EC, amended by 98/81 on
contained use of GMOs and Regulation
1946/2003/EC on the transboundary
movement of GMOs. It does not cover the
regulation of the GM food and feed, which
are addressed by the Regulation of novel
food, implemented by the Ministry of
Health. The draft of the GMO law has been
prepared in the frame of UNEP/GEF pro-
ject on implementation of biosafety frame-
work in the country, coordinated by Agro-
bioinstitute, Sofia. Due to the specific sci-
entific matter and its potential impact on
the environment and human health, this
Law has been discussed for more than two
years by the Parliament. Meanwhile, an
interim regulation “Guideline for the dis-
persal of genetically modified higher
plants, developed through DNA recombi-
nant technology” has been adopted (1996)
in accordance with the EU Directive
90/220 in place of that time. In 1998 the
Bulgarian government established a Coun-
cil for the Safe Use of Genetically Modi-
fied Higher Plants as required by the
guideline. Members of the Council were
representatives from the Ministry of Agri-
culture and Forests, Ministry of Environ-
ment and Waters, Ministry of Health, the
Executive agency for seed production, ap-
probation and seed control, the National
service for plant protection and agrochem-
istry as well as representatives from the
scientific community. Chairman of the
Council is the Minister of Agriculture and
Forests, and Executive Secretary is a
prominent scientist in the field of genetic
engineering.
Bulgaria was one of the first of the Cen-
tral and East European (CEE) Countries to
release genetically modified organisms
(GMOs) in open field trials. The Council
was the only body to grant permits con-
cerning GMO environmental releases
(small- and large scale field trials). Up to
20th Anniversary AgroBioInstitute - R&D
date, approvals for commercial planting of
GMO have not been granted.
According the new law on GMO, the is-
suance, change or withdrawal of permits
for the contained use GMO falls under the
service of the Ministry of Environment and
Water, while the Ministry of Agriculture
and Forestry is competent for legal aspects
of placing of GM products on the market,
as well as for the issues of import and ex-
port of GMOs (Figure). Public discussions
and initiatives for building up science-
based public awareness are in the preroga-
tives of this Ministry. A polarizing debate
is going on on the public arena, which en-
compasses different stakeholders: scien-
tists, politicians, consumer and ecological
organizations. This is why the two-way
science-based communication and trans-
parency are an important tool, facilitating
the successful implementation of the holis-
tic biosafety framework. To respond to this
critical need, A Bulgarian Biotechnology
Information Center has been established
within Agrobioinstitute, Sofia. The Center
operates since December 2003 and its main
activities are development and management
of a bilingual biotechnology & biosafety
website (http://www.bgbic.abi.bg/), pub-
lishing of information papers, brochures,
bulletins, organization of workshops and
discussion clubs with university students in
the field of agricultural biotechnologies and
their safe application.
A GMO law in the context of Bulgaria
should combine the international obliga-
tions of the country with the particularities
of the local legislative system and the Di-
rectives of the European Commission in
order to implement its major function: en-
suring control on the import, trade and use
of GMOs to guarantee their safe use for
human health and environment.
It is necessary to mention that the draft
GMO law, before the modifications during
the second reading, complied with all ex-
isting appropriate EU Directives and inter-
national agreements. It has been prepared
165 Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue

MINISTRY OF AGRICULTURE Food Safety and Food
AND FORESTRY Control Directorate
Control Bodies
AgroBioInstitute National Veterinary Service; National
Grain and Feed Service; Executive
Agency Plant Variety Testing,
Approbation and Seed Control;
Executive Agency for Vines and
Wine; National Service for Plant
Protection, Quarantine and
Agrochemistry; Executive Agency
Fisheries and Aquacultures; National
Forestry Directorate; Executive
Agency Fisheries and Aquacultures
Control on Import, Export
and transit of GMO
Customs Agency according to Council of
Ministries decree to
Custom Agency
Consulting Standing
Commission for GMO
Issues and Decisions
MINISTRY OF ENVIRONMENT
Executive Environmental
AND WATER Agency
MINISTRY OF LABOR AND General Labour Inspectorate -
SOCIAL POLITICS Executive Agency
Figure. Structure of the official authorities described in GMO Act.
Biotechnol. & Biotechnol. Eq. 19/2005 166 20th Anniversary AgroBioInstitute - R&D
Special Issue
Granting Authorizations for
placing on the market of GMO
and establishing and keeping
official public register
DUTIES
1. Carrying out field trials;
2. Using GM products for plant
protection;
3. Placing on the market of GM
seeds, plants and animals, feed
and feed additives and GM
products for plant protection.
The main activities of the ABI
GMO detection and
identification; method validation,
threshold determination
Issues decisions for
1. Contained use of GMO;
2. Release of GMO into the
environment
3. Placing of GMO on the market
Granting Authorizations for
Releasing of GMO in
environment;
Granting Authorizations for
Contained use of GMO;
Establishing and keeping official
public register.
Control on releasing of GM and
establishing and keeping official
public register
Control on implementation of
GMO Act, safety mesures
during the contained use of
GMO.
by qualified professionals- lawyers, experts
and scientists within the Ministry of Agri-
culture and Forests, Ministry of Environ-
ment and Waters, Ministry of Health, Min-
istry of Economy, Ministry of Education
and Science, the Executive agency for seed
production, approbation and seed control,
and the National Center for Agricultural
Sciences. Before the submission of the
draft GMO law in the Parliament, it has
been revised and positively estimated by
leading international experts in this field
from EU and UN organizations. The par-
liamentarian Commission of the Environ-
ment and Waters, has added some articles
that are inconsistent with the legislative
biosafety framework in European Union.
These are namely:
А. Article 77a (1) states: The deliberate
release and the placing on the market of the
following GMOs: tobacco, grape, cotton,
oil rose, wheat and all vegetables and fruits
is prohibited.
Nowhere in the world, including the EU-
Member-States prohibitions for deliberate
release of specific crops are in place but
rather options for refusal for deliberate re-
lease into the environment and placing on
the market after the performance of specific
procedure: notification with providing a
detailed dossier; checking the dossier for
completeness; performance of science
based risk assessment and decision upon
risk-benefit of the competent national
authority (which is political and may not be
based only on the scientific results) and
after a public debate for the introduction of
the specific GM event .
Moreover, such a prohibition can easily
be interpreted as confrontation with EU
policy and as a technical barrier to interna-
tional trade (according to the TBT- WTO-
agreement) and thus, Bulgaria risks to bear
severe international sanctions. It might be
useful to remind that since 2003 USA,
Canada, Argentina, Egypt and other coun-
tries brought a complaint against EU,
which relates to the delay of the procedure
20th Anniversary AgroBioInstitute - R&D 167
for granting an approval/ban for placing on
the market of GMOs, the so called de facto
moratorium. Influenced by this interna-
tional pressure, 24 GM plant varieties were
considered safe for placing on the EU mar-
ket as food and feed in the period July-
October 2004, which marks serious libe-
ralization in the EU policy in the field of
biotechnologies.
B. The article 3a from the additional
provisions however threatens seriously the
development of the biotechnological sci-
ence in Bulgaria, stating: The genetic
modifications with oil rose, grape and to-
bacco are prohibited on the territory of
Republic of Bulgaria. This provision prac-
tically prohibits the even the work in con-
tained, strictly controlled laboratory condi-
tions with these three emblematic and eco-
nomically important crops when the
method of genetic transformation is used.
It is evident that the Bulgarian GMO Act
has been strongly influenced by the spirit
of restrictiveness of the EU legislative sys-
tem and especially by the interference of
non-governmental ecological organizations
and organic farmers’ associations (although
the rate of organic farming in Bulgarian
agriculture is less than 1% and the market
of organic products is extremely limited). It
goes much beyond the EU biosafety
framework by putting a ban on carrying
scientific experiments with specific plant
species, especially in the case, in which
such species are priority for the country’s
economy. This automatically exclude the
consideration of the benefits of the gene
technology for the farmers and Bulgarian
economy and with regard of the research it
will hinder the developments both of ap-
plied science and the basic research in
plant sciences as functional genomics, in
which transgenes are used to knock out a
given gene in order to discover its function
in the organism. Such research is predomi-
nantly done on tobacco, which is a model
plant and the techniques of genetic trans-
formation and regeneration are well estab-
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
lished. A social impact of such politicizing
of the GMO issue, which only precedent in
the modern history was the Lisenko’s pe-
riod in the USSR in the 60s, when the ge-
netics has been politically denied, would be
a possible regress of Bulgarian life science,
loss of competing ability of Bulgarian re-
searchers and enhancing of already high
rate of brain drain of highly educated
young people from the country.
Needs and opportunities for
coordination and harmonization
International cooperation and
harmonization
Biosafety as an international, multidiscipli-
nary process requires a collective and syn-
ergetic approach. Various entities, which
include the Intergovernmental Committee
for the Cartagena Protocol (ICCP), the
Convention on Biological Diversity (CBD)
Secretariat, the Global Environmental Fa-
cility (GEF), other bilateral and multilateral
agencies, intergovernmental bodies, non-
governmental organizations, the private
sector and academic institutions may all
play diverse and often complementary roles
in coordinating and harmonizing related
issues. It is argued that synergism and co-
operation in this field may be a very diffi-
cult task since the requirements and inter-
ests of the stakeholders may differ signifi-
cantly. For instance, both the Protocol on
Biosafety under the CBD and the Agree-
ment on Sanitary and Phytosanitary Mea-
sures (SPS) of the World Trade Organiza-
tion (WTO) cover trade in biotechnology
products. However, each agreement treats
the “precautionary principle” differently.
Trade disputes on living modified orga-
nisms will use either agreement, depending
on each country's status according to each
agreement. Trade and environment agree-
ments aspire to be mutually supportive, but
to do so here requires substantial harmoni-
zation between the two agreements.
To facilitate the implementation of a se-
ries of international agreements, there are
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
formally expressed needs for clear regula-
tion and a protocol that together may har-
monize biosafety internationally, limit the
perceived concerns associated with the re-
lease of genetically engineered organisms.
Harmonized rules would enhance interna-
tional collaboration and prevent experi-
ments from being relocated to countries
with more lax regulations thus avoiding
bans. Policing such regulations would be
difficult, especially if the rules are not le-
gally binding. However, standards, legal
measures and regulations concerning bio-
technology should fix only the “essential
requirements” (notification, authorizations
and procedures) and several product-based
(so-called “vertical”) directives and regula-
tions, leaving space for voluntary actions
by manufacturers. There is a concern espe-
cially in the developing world that if
strictly unified regulations would be
adopted, then they would not take into ac-
count the specific requirements of every
country (Gupta, 2000). They would then be
less effective and could potentially damage
the indigenous resources regulations. Con-
siderable efforts in identifying and estab-
lishing international harmonized principles
and guidelines in risk analysis and safety
assessment of foods derived from GM
plants and micro-organisms have being
made by the Codex Ad Hoc Task Force on
Foods Derived from Biotechnology.
There is a common understanding that
international and regional harmonization
should focus on the issues of strengthening
capacities and information sharing for
safety in biotechnology. ICCP and CBD
Secretariat play a central role in coordina-
ting the existing initiatives in this field.
The GEF/UNEP project "GEF Initial
Strategy for Assisting Countries to Prepare
for Entry into Force of the Cartagena Pro-
tocol on Biosafety" is an important contri-
bution for promoting identification, col-
laboration and coordination among the bi-
lateral and multilateral organizations to
assist capacity-building and for optimiza-
168 20th Anniversary AgroBioInstitute - R&D
tion of partnerships.
In order to enhance the exchange of in-
formation and facilitate cooperation among
a considerable number of organizations
working actively in the field of biosafety,
an Inter-Agency Network for Safety in
Biotechnology (IANB) has operated since
1999, chaired by the OECD. The Consul-
tative Group on International Agricultural
Research (CGIAR), CBD, ICGEB, FAO,
OIE, OECD, the United Nations Confe-
rence on Trade and Development (UNC-
TAD), UNEP, UNIDO, WHO and WTO
are presently part of that Network (16).
All attempts from different organizations
and bodies use a similar approach to coor-
dinate and harmonize ongoing biosafety
activities in the international arena. This
includes assessing and identifying the
needs and areas for collaboration (such as
institutional building, risk assessment, risk
management and public awareness), ca-
pacity-building and information-sharing.
Priorities are made on a county and regional
basis to bring together the collaborating
parties in order to answer those needs.
Regional and sub-regional
harmonization initiatives
This section covers several examples of
North-North, North-South and South-South
cooperation that focuses on harmonizing
the existing regulatory systems in the regions.
USA-Canada
In 1998, officials from CFIA, Health
Canada and the APHIS of the US Depart-
ment of Agriculture signed an agreement
on commonalties in the molecular genetic
characterization of transgenic products and
on the development of reviewers’ che-
cklists. This bilateral initiative was re-
sumed in September 2000 and attended by
an Argentine representative at a USDA
meeting in the context of the US-Canada
agreement on molecular biology data stan-
dardization. The meeting aimed at com-
paring regulatory requirements and setting
the stage for harmonizing molecular biolo-
gy data and environmental risk assessment
20th Anniversary AgroBioInstitute - R&D 169
criteria.
Argentina-USA
In 1999, in Argentina-USA Agrifood
Consultative Committee meetings with
USDA and EPA officers, biosafety systems
in both countries were examined to identify
opportunities for regulatory harmonization.
The main objective was to standardize cri-
teria and procedures for authorising uncon-
fined GMO plating prior to full commercial
release ("flexibilization" in Argentina,
"non-regulated status" in USA). Granting
mutual access to data on post-commerciali-
zation monitoring, and other areas of coo-
peration were also discussed. In particular,
biosafety authorities in Argentina are con-
sidering the possibility of adopting the
Checklist of Molecular Biology Data Re-
quirements currently operating under the
Canada-USA Bilateral Agreement on Agri-
cultural Biotechnology.
Workshop on regulation of biosafety in
the southern cone
This Workshop, held in Buenos Aires on
14-20 November 1992, was commissioned
by the Consultative Council for Coopera-
tion in Agriculture in the Countries of the
South Area (CONASUR), viz. Argentina,
Brazil, Chile, Paraguay and Uruguay, and
organized by the Inter-American Institute
for Cooperation in Agriculture (IICA) and
the International Service for the Acquisi-
tion of Agri-biotech Applications
(ISAAA). It aimed to prepare a sub-re-
gional programme for the development of
regulations for evaluating and monitoring
agro-biotechnological products. In sum,
this document recommends:
• To regulate, in the short-term, the intro-
duction and release of transgenic plants
in the countries of CONASUR according
to the existing legislation for plant quar-
antine, seeds, pesticides and related sub-
jects; and to regulate the use of and pro-
cedures for obtaining a product and po-
tential risk for the environment, agricul-
ture or public health;
• To regulate, approve and monitor field
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
 trials and commercialization under the
responsibility of organ(s) of the Minis-
tries or Secretaries of Agriculture;
• To create, at the national level, commis-
sions or committees for consultation and
technical support to assist the ministerial
organ in the design and administration of
the regulations;
• To use experts from various areas of the
public and private sectors involved in
plant biotechnology for consultative
commissions;
• To have the applicant bear the evaluation
costs of field trials;
• To decide on the evaluation verdict within
a period of up to 120 day after the claim;
• To have the national organ responsible in
conformity with the applicant define the
type of information that could be consi-
dered confidential;
• To evaluate field trials based on general
criteria considering the ecosystem, the
biological characteristics of the products
and its possible effects on the health of
personnel in charge of the trial, previous
similar trials in other countries or re-
gions, and on the existence of measures
to control potential organism escapes;
• To provide a field trial application con-
taining a detailed description of the mate-
rial, its origin and uses, the methodology
to be applied in the trial and other rele-
vant information; and
• To inform public opinion of the priority
criteria on trials and the release of trans-
genic plants.
In 1995, delegates to the Second Latin
American Meeting on Plant Biotechnology
agreed on the need to harmonize national
rules for the supervision and monitoring of
field trials and the marketing of transgenic
materials. As a result of this agreement,
representatives from Argentina, Brazil,
Paraguay and Uruguay, with Bolivia and
Chile as observers, met later the same year
in Buenos Aires. The recommendations
made at this meeting were to (a) urgently
develop national advisory committees and
Biotechnol. & Biotechnol. Eq. 19/2005 170
Special Issue
regulatory frameworks where needed; (b)
continue in-depth examination of the po-
tential for regional harmonization, with a
focus on marketing transgenic plants; and
(c) agree on the profile of a regional data-
base (Conclusions and recommendations
from the workshop on regulation of bio-
safety in the southern cone, 1993).
Black Sea Biotechnology Association
Black Sea Biotechnology Association
(BSBA, http://www.bsbanet.org) is an as
international public non-profit organization
with seat in Sofia, Bulgaria and has been
established with the mandate to contribute
to the protection of human and animal
health and the environment with respect to
the introduction of GMOs from one hand,
and to stimulate economic development,
modern agricultural practices and modern
biotechnology from the other. BSBA
members are so far representatives from
scientific and breeding institutions from
Bulgaria, Russia, Turkey, Ukraine, and
Romania. The countries presented in the
BSBA, having all strong traditions in agri-
culture and trade of agricultural products,
are exploring the Black Sea through multi-
ple sea ports as major transport means for
import and export of commodities, inclu-
ding agricultural (grain) commodities.
Common feature for these countries is
that they have established practices and
significant scientific potential in agricul-
tural biotechnology. The import and
growing of GM crops in Bulgaria, Turkey
and Ukraine are not permitted and in Rus-
sia аnd Romania there is a partial permis-
sion for given crops or products. Only few
of the countries have clear and transparent
regulatory system for the exchange and
marketing of biotech crops. Moreover, the
perception how it should be regulated and
monitored (post market) is lacking.
The overall objectives of the BSBA in
compliance with the above mentioned con-
cept are to:
- Create within the Black Sea region, a
network of countries with historically
20th Anniversary AgroBioInstitute - R&D
 similar agricultural needs, priorities and
often practices
- Create science based regulations that not
only protect the public health and the re-
gional environment, but also stimulate
economic development, international
trade, modern agricultural practices, mo-
dern food and feed production industry
- Promote east/west collaborations and the
advancement of regional varieties.
- Increase the region’s contribution to and
participation in the global debate re-
garding agricultural biotechnology.
- Build an accredited certification system of
mutual recognition of regulatory and
safety data for agricultural products and
trade commodities improved through
biotechnology.
- Educate policy makers, press and general
public regarding Biotechnology
Bulgaria has been chosen to play host to
the Association because of the fact that he
country is among the leaders of biotech-
nological research and Agrobioinstitute is a
coordinator for the biosafety in Central and
Eastern Europe. Bulgaria has optimum po-
litical and geographical locality that con-
nects three continents.
Expected outcomes of these activities
will be a better control in the area of bio-
safety of food and feed, and environmental
risk assessment; science- and fact-based
public awareness about the safe use of the
products of modern biotechnology, pro-
vided in an accessible and user-friendly
format; harmonization of the legislation of
GMOs at international (Cartagena Protocol
on Biosafety), European and regional level;
as well as stimulation of the regional eco-
nomic development with respect to bio-
safety, biotechnology and sharing of best
agricultural practices.
Conclusions
The countries participating on the Earth
Summit in 1992 have agreed upon the fact
that biotechnology can offer indubitable
benefits to sustainable development, world
20th Anniversary AgroBioInstitute - R&D 171
food supplies and economic prosperity. In
order this potential to be largely applied
worldwide and with particular emphasis in
developing countries and thus facilitating
the alleviation of poverty, the countries
joined their efforts in preparation of inter-
national rules, which would both ensure the
further development of biotechnology for
the benefit of the society at large and the
conservation of genetic resources, espe-
cially in the centres of origin (mostly situ-
ated in the third world). The international
rules, reflected both in the Cartagena pro-
tocol on biosafety and the WTO agree-
ments are built on scientific basis and pro-
mote the case-by-case approach, i.e. every
transgenic event should undergo separate
risk assessment and potential hazards, spe-
cific to this event should be identified and
specific risk management measures assigned.
The specific international agreements
that threat different aspects of the products
of modern biotechnology (GMOs) how-
ever, as any other international instruments,
are results of negotiations and compro-
mises. In the last years, there are some ten-
dencies in the negotiations of a few inter-
national instruments, e.g. the Cartagena
protocol on biosafety and the Aarhus con-
vention on public participation that diverge
from the initial idea of the Earth Summit,
by taking into consideration only the
eventual negative effects that might be as-
sociated with the deliberate release into
environment of the products of modern
biotechnology. Some countries and non-
governmental organizations have expressed
their willingness for stricter liability re-
gimes that are in the position to hinder the
development of public research in the
countries, particularly developing countries
and countries with economies in transition.
The policy makers in these countries
should take into account the fact that public
research is always oriented respond to a
specific problem in the country’ s agricul-
ture or medicine and has a clear social
benefit –driven feature. Moreover, the sci-
Biotechnol. & Biotechnol. Eq. 19/2005
Special Issue
entific problematic of the public research is
not addressed by the multinational biotech
companies, which products are mostly in
commodity crops that are able to bring fast
and considerable profits.
In the past years several international in-
struments that consider different aspects of
the trade, transboundary movement and
potential adverse effects for the environ-
ment of GMOs have been agreed. In most
of the cases, closer interaction and coo-
peration, as well as further harmonization
among these agreements would be reco-
mmendable. Unified stricter regimes may
lose on flexibility and would not be able to
satisfy the needs and interests of every
country, particularly developing countries.
Other than relying on international in-
struments e.g. the Cartagena Protocol on
Biosafety, the countries all over the world
are highly encouraged to develop their own
national biosafety frameworks (GEF pro-
ject) that would better reflect the countries’
needs in terms of import- export of the
products of modern biotechnology. There
are several models of such national regula-
tions, overviewed in this paper that may be
effective in building up a workable bio-
safety system. Which model to be chosen
depends on the policy of the given country
and should be in accordance with its inter-
national and regional obligations. It is
commonly understood that international
and regional harmonization, in addition to
synchronizing the national regulatory
frameworks, should focus on the issues of
strengthening capacities and information
sharing for biotechnological safety. Many
countries, especially in the developing
world, need to acquire the technology and
the capacities necessary to sustainably han-
dle the results of modern biotechnology.
Therefore, public awareness, education and
technology transfer play an important role.
A number of international organizations
such as FAO, WHO, UNEP, UNIDO,
OECD, ICGEB and CGIAR, as well as the
shown examples of regional cooperation
Biotechnol. & Biotechnol. Eq. 19/2005 172
Special Issue
are in the position to offer necessary assis-
tance in capacity-building and dissemina-
tion of information on biosafety.
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