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Work Package 6

Activity 6.1

International Multi-level Governance of GMOs: The EU, USA and Indian cases.

Authors:

Nuria Vazquez Salat, KCL

Prof Brian Salter, KCL

Greet Smets, PERSEUS

September 2010

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TABLE OF CONTENTS TABLE OF CONTENTS......................................................................................................................................... 2

GLOSSARY ......................................................................................................................................................... 4

EXECUTIVE SUMMARY ...................................................................................................................................... 6

INTRODUCTION ............................................................................................................................................... 11

CASE STUDY 1: EUROPEAN UNION ................................................................................................................. 13 1.INTRODUCTION TO THE REGULATORY FRAMEWORK OF GMOs .................................................................. 13

1.1.GMO Legal Framework .......................................................................................................................... 13

1.2.Regulatory Bodies .................................................................................................................................. 16

1.2.1.European food safety authority (EFSA)........................................................................................... 16

1.2.2.European Medicine Agency (EMA) ................................................................................................. 17

1.2.3.DG SANCO ....................................................................................................................................... 18

1.2.4.DG AGRI .......................................................................................................................................... 19

1.2.5.Other related Directorates ............................................................................................................. 19

2.THE REGULATORY FRAMEWORK IN CONTEXT ............................................................................................. 21 2.1.Food and Feed Sector ............................................................................................................................ 21

2.1.1.Risk Assessment .............................................................................................................................. 23

2.1.2.Risk Management and Communication ......................................................................................... 25

2.2.Pharmaceutical Sector ........................................................................................................................... 27

2.2.1.Risk Assessment .............................................................................................................................. 28

2.2.2.Risk Management and Communication ......................................................................................... 29

3.GM ANIMALS IN THE EUROPEAN UNION ..................................................................................................... 30

CASE STUDY 2: UNITED STATES OF AMERICA ................................................................................................ 33 4.INTRODUCTION TO REGULATORY FRAMEWORK ......................................................................................... 33



4.2.1.National Institutes of Health (NIH) ................................................................................................. 35

4.2.2.Animal and Plant Health Inspection Service (APHIS) ...................................................................... 35

4.2.3.Environmental Protection Agency (EPA) ......................................................................................... 36

4.2.4.Food and Drug Administration (FDA) ............................................................................................. 38

5.THE REGULATORY FRAMEWORK IN CONTEXT: ............................................................................................ 41 6.GM ANIMALS IN THE USA ............................................................................................................................. 45

CASE STUDY 3: INDIA ...................................................................................................................................... 48 7.INTRODUCTION TO THE REGULATORY FRAMEWORK .................................................................................. 48



7.2.1.Institutional Biosafety Committee (IBSC)........................................................................................ 51

7.2.2.Review Committee on Genetic Manipulation (RCGM).................................................................... 51

7.2.3.Genetic Engineering Approval Committee (GEAC) ......................................................................... 51

7.2.4.Other regulatory bodies ................................................................................................................. 52

7.2.5.The Biotechnology Regulatory Authority of India (BRAI) ................................................................ 52

8.THE REGULATORY FRAMEWORK IN CONTEXT ............................................................................................. 53 8.1.Food and Feed Sector ............................................................................................................................ 54

8.2.Pharmaceutical Sector ........................................................................................................................... 58

9.GM ANIMALS IN INDIA ................................................................................................................................. 59

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INTERNATIONAL CONTEXT ............................................................................................................................. 62 10. INTRODUCTION TO THE INTERNATIONAL ORGANISATIONS ..................................................................... 62

10.1.Organisation for Economic Co-operation and Development (OECD) .................................................. 62

10.2.World Health Organisation (WHO) and Food and Agricultural Organisation (FAO)............................ 63

9.1.1.Codex Alimentarius ......................................................................................................................... 64

10.3.World Trade Organisation (WTO) ........................................................................................................ 65

10.3.1.SPS, TBT and TRIPS Agreements ................................................................................................... 66

10.3.2.GMOs and the WTO dispute ......................................................................................................... 67

10.4.Global Environment Facility (GEF) ....................................................................................................... 68

10.4.1.Cartagena Protocol ....................................................................................................................... 69

10.5.World Organisation for Animal Health (OIE) ....................................................................................... 70

10.5.1.OIE’s Code and Manual ................................................................................................................ 72

11. INTERACTION BETWEEN STATES AND INTERNATIONAL ORGANISATIONS ............................................... 72 11.1.The continuing international debate ................................................................................................... 73

11.2.Comparison of GMO Regulatory Frameworks..................................................................................... 77

12.GM ANIMAL REGULATION IN THE INTERNATIONAL CONTEXT .................................................................. 81

REFERENCES .................................................................................................................................................... 85

APPENDIXES .................................................................................................................................................... 87 Appendix 1. LIST OF INTERVIEWEES ............................................................................................................ 87

Appendix 2. TABLE WITH GMO REGULATIONS – EUROPEAN UNION ......................................................... 88

Appendix 3. TABLE WITH GMO REGULATIONS – UNITED STATES OF AMERICA ......................................... 90

Appendix 4. TABLE WITH GMO REGULATIONS – INDIA .............................................................................. 90

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GLOSSARY

APHIS Animal and Plant Health Inspection Service

CAC Codex Alimentarius Commission

CF Co-ordinated Framework

CP Cartagena Protocol

CVM Centre for Veterinary Medicine

DBT Department of Biotechnology

DG AGRI Directorate General for Agriculture

DG ENV Environment Directorate-General

DG RTD Research Directorate-General

DG SANCO Directorate General for 'Health and Consumers'

DG TRADE Directorate General for Trade

EC European Commission

EFSA European Food Safety Authority

EMA European Medicines Agency

ENGOs Environmental Non-Governmental Organisation

EPA Environmental Protection Agency

ERA Environmental Risk Assessment

EU European Union

FDA Food and Drug Administration

FFDCA Federal Food, Drug and Cosmetic Act

FIFRA Federal Insecticide, Fungicide and Rodenticide Act

GE Genetically Engineered

GEAC Genetic Engineering Appraisal Committee

GEF Global Environment Facility

GMO Genetically Modified Organism

INAD Investigational New Animal Drug

LMOs Living Modified Organisms

MEP Member of the European Parliament

MS Member State

NADA New Animal Drug Application

NCA National Competent Authority

NEPA National Environmental Policy Act

OIE World Organisation for Animal Health

PIP Plant-Incorporated Protectant

RA Risk Assessment

RAF Resource Allocation Framework

rDNA Recombinant DNA

RCGM Review Committee for Genetic Modification

SPS Sanitary and Phytosanitary

TBT Technical Barriers to Trade

TRIPS Trade Related Aspects of Intellectual Property Rights

UNEP United Nations Environmental Programme

USA United States of America

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WHO World Health Organisation

WTO World Trade Organisation

ZTP Zero Tolerance Policy

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EXECUTIVE SUMMARY

PEGASUS is an integrated project, funded by the EU in the Seventh Framework Programme

which aims to provide policy support to the EC regarding the development, implementation and

commercialisation of GM animals and derivative foods and pharmaceutical products. The

objective of Work package 6 (WP6) is to examine the political and policy context of the

introduction of GM animals in order to be able to identify policy gaps and make policy

recommendations to the Commission. This first scoping report reviews the major components of

that context as prelude to subsequent policy analysis that will respond to the findings of the other

work packages.

THE CONTINUING DEBATE

Since the first GMOs entered into the market in the 90s, science has continuously evolved

further refining its techniques. As it has done so, states have continued to respond with changes

in their regulatory frameworks in order to adapt to the new challenges. In the course of this

policy making, each state (or in the case of the EU, collection of states) is subject both to its own

particular pressures from interest groups and citizens, and to the influence of various forms of

global governance (e.g. trade, economic competitiveness, etc.) that have a direct impact on the

governance of GMOs .

Despite the similarity of the techniques at the R&D stage, GM applications have followed

diverging paths dependent on their final use. Pharmaceutical applications or red biotechnology,

with clear benefits to the consumer, have remained immune to GMO controversy with the debate

surrounding them exclusively science-driven. Food applications or green biotechnology, on the

other hand, have proved contentious in some states (though not in all) with the debate spanning

a wide range of cultural and ethical issues in addition to the scientific ones. Consumer support, or

the lack of it, is widely recognised as the main driving force influencing the commercial viability of

these applications and as a consequence, of the policy approach taken by each state. In addition,

the interplay among different stakeholders (e.g. industry, scientists, environmental NGOs) has

also influenced GMO governance. The agrochemical industry rapidly embraced the GM

technology presenting it as a major solution to the needs of the growing human population,

particularly in deprived communities. Having united against the precautionary principle, industry

found itself the target of diverse anti-GM groups concerned with traditional agriculture,

protection of the environment and, more importantly, fighting against capitalism and the role that

multinational companies play in an increasingly globalised world. The scientific community,

another important player, has remained in large part detached from the public debate and the

policy making process. Indeed, activists movements have greatly exploited the different

understanding of risk and uncertainty that the scientific community has when compared to lay

audiences.

Although international organisations are on the whole less responsive to these non-

governmental influences than states, there is a degree of diversity in the permeability of these

bodies to interest groups. Certain international bodies are more accessible to stakeholders (e.g.

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CAC, WHO, GEF) than others (e.g. WTO, OIE). This permeability however, has not caused any

operational problems. Within the highly polarised GMO debate, international bodies have played

a key role in keeping the debate relatively open and neutral. Organisations such as the OECD, CAC

and WHO/FAO have taken an active role in developing international guidelines that harmonise

the risk assessment of GMOs. In response to their intervention, the main areas of initial conflict,

such as risks to human health and the environment, have been tackled with some success at

international level.

International organisations, on the other hand, have not been able to unify the different

array of policy approaches to GMOs that states have adopted since this would naturally conflict

with state sovereignty. Consequently, international trade has been affected by the polarisation of

the GMO debate and its associated cultural and economic conflicts. Over the years, there has

been a global negative impact on the export/import of agricultural goods and an increase in issues

concerning asynchronous authorisations, adventitious presence, illegal seed trade and labelling

disagreements.

The difficulties in reconciling trade and environment issues have been a constant theme in

the history of the GMO debate. The OECD is one of the few international bodies responding to

these concerns, developing the Joint Working Party on Trade and the Environment (JWPTE). The

Cartagena Protocol (CP) supported by GEF-UNEP, is the only international agreement to address

both trade and the effects of GMOs on the environment. However, the CP’s lack of liability and

compliancy provisions in addition to the significant reduction of the Secretariat’s resources has

diminished its potential impact. The unresolved complexities surrounding the trade of GM goods

have brought the WTO into the GMO debate. Despite the organisation’s narrow remit on trade

liberalisation, it remains an exceptionally strong international player. In addition, the role of WTO

in resolving disputes regarding GMOs can also have an impact on the importance of other

organisations (i.e. CAC, IPCC, OIE), which are used as reference point in the WTO legally-binding

agreements.

The international GMO debate will continue to evolve with science constantly challenging

the states’ regulatory frameworks. However, there have been recent efforts in reducing the level

of polarisation through the adoption of international guidelines. In addition, developing countries

started embracing this technology, increasing the number of international players. These new

players are likely to have a role in re-shaping the global GMO agenda placing further emphasis on

the harmonising role of international bodies.

GMO GOVERNANCE IN THE EU, USA AND INDIA

Within this international context, the EU, USA and India have responded to domestic

influences in the construction of their regulatory frameworks. The USA has taken a more relaxed

approach helped by the acceptability of GM food to the American consumer and the role of

biotechnology industry in shaping the regulations. India’s approach balances the need to provide

food safety whilst minimising the risks of GMOs. The EU, in response to the public concerns raised

by the “Frankenfoods” campaigns, has developed a regulatory framework that is in theory in line

with international standards but in reality, remains the most restrictive in the world. In the light of

the distinctive qualities of these approaches, we developed our analysis using the 3 principles

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employed by policymakers in dealing with risk (risk assessment, risk management and risk

communication) as a template.

Risk Assessment

India and the EU have adopted process-based regulations in line with the Codex guidelines.

In contrast, the USA has used its existing regulations to assess the safety of the different GM

products. For pharmaceutical applications, there were no significant problems in the area of risk

assessment. For food applications on the other hand, politics have regularly intermingled with

science at the RA stage. There was overall agreement among scientists involved in risk assessment

that allergenicity and environmental assessment are the main areas of conflict. There are a

number of scientific bodies involved in the development of the risk assessment in all 3 case

studies. In the EU, EFSA (food applications) and EMA (pharmaceutical applications) produce the

RA in collaboration with NCAs. In the USA, 3 agencies (EPA, FDA and USDA) have been involved in

the regulation of both food and pharma applications depending on the final product. In the past,

in India there were 3 regulatory bodies (IBSC, RGCM and GEAC) involved in the production of the

RA although this will soon change with the development of BRAI.

Risk Management

Differences start to crystallise at the risk management stage not only among case studies

but also, in terms of the GM application. Indeed, it is at this stage that socio-economic

differences, such as trade and cultural/ethical values, have had the greatest impact. For the

pharmaceutical arena, the risk management process is operational in all 3 case studies despite the

fact that the technology is still very new with most of the applications at the clinical trial stage.

For the food/feed arena, the politicisation of the GMO issue in the EU has virtually paralysed the

operation of its comitology procedure. Similarly, the introduction of the first GM food crop (Bt

brinjal) in India was not successful. Activists succeeded in mobilising the increasing wealthy

cosmopolitan Indian population in a quest to challenge the government’s approval. A different

situation exists in the USA, the major GM crop exporter. Despite few GMO scandals (e.g. StarLink,

Prodigene, etc.) the regulatory agencies are trusted by the American citizens.

Risk Communication

Of the 3 case studies, the Indian government is the most active in risk communication with

Indian policy makers accustomed to dealing with pressures from a variety of interest groups

through the use of the media and formal risk communication measures. Despite the quiescence

of GM activism in the USA, the government has maintained an active role in a positive portrayal of

GMOs as a vehicle for sustaining public trust in the field. Finally, as a supra-national state, the EU

has been exposed to a high number of polarised interest groups which have further isolated the

policy making process from the European citizen. Furthermore, in the EU, the development of a

centralised risk communication strategy to deal with a frequently disaffected public has been

hampered by the manifest divisions between MS on GMOs.

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THE INTRODUCTION OF GM ANIMALS

GM animals are situated within an existing system of global, regional (EU) and national

GMO governance characterised by a limited degree of global harmonisation, stasis at the EU level

and wide national differences. It is to be expected that the political and cultural pressures that

have impacted on the policy process to produce these differences will continue to do so as the

GM animal field develops. Existing interest groups will take on the issue and new ones, such as

animal welfare organisations and breeding organisations, will enter the fray. It is therefore likely

that the GMO debate will be re-opened but with an added layer of complexity caused by the

different forms of cultural attachment to animals.

Some states have anticipated the voluntarily or involuntarily entrance of transgenic animals

into their domestic markets and begun to amend their GMO regulation to accommodate animals.

Of the 3 case studies, the USA has made the most significant regulatory changes treating

transgenic animals as “new drugs” and regulating them under the FFDCA which requires a

mandatory risk assessment that will analyse (for the first time) the transgenic animal as a whole.

By incorporating the Codex guidelines into this regulation the USA anticipates that it will avoid the

trade barriers encountered with GM plants. In the USA there are already 2 GM animals in the

market (i.e. ATryn goat and GloFish) and one close to market (AquAdvantage salmon).

India’s GMO regulatory framework is broad enough to deal with GM animals, particularly

with the creation of the BRAI, although there is a need for specific guidelines on the assessment

of GM animals. Important influences on the way its policy develops are the cultural (significance

of animals to the Hindu and Buddhists religions, proportion of vegetarian population) and

economic (high cost of GM technology compared to GM plants and lack of economic power of a

substantial percentage of the Indian population).

In the EU, the scope of the GMO regulatory framework means that in principle it can deal

with GM animals, including the ethical and socioeconomic considerations. Currently EFSA’s GMO

panel is working with the animal welfare panel on specific guidelines for GM animals whilst EMA

is updating the existing guidelines on animal bioreactors. However, the difficulties associated

with the comitology procedure for GMO food/feed applications will inevitably impact on the

regulation of GM animals.

A key problem in international governance is likely to be the harmonisation of the diversity

of cultural values regarding GM animals. Several international bodies had already developed

guidelines specific to transgenic animals in the 90s, when there was a belief that GM animals

would soon reach the market. These guidelines will need to be updated to include the latest

advancements in science. The OIE is expected to play an important role and through its scientific

and technical department has experience in dealing with tensions between science and cultural

values as well as a strong emphasis on monitoring the implementation of its guidelines.

Nevertheless, with the exception of the OECD (currently working on a consensus document on the

biology of salmon), there appears to be little planned activity on GM animals at international

level.

Issues related to GMO trade are expected to increase with the arrival of GM animals. The

WTO Agreements are likely to remain the international reference point for food/pharma products

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derived from transgenic animals. Because the OIE sets the standards on animal health, the WTO

should be able to deal with disputes regarding GM animal trade. It still remains to be seen how

the different ethical and cultural values surrounding GM animals will be dealt with by such a

trade-oriented organisation.

In all 3 case studies, pharmaceutical applications are seen to have significant socio-

economic advantages when compared to food applications. Nevertheless, the array of players and

their role in shaping the regulation will be different for the breeding and the pharmaceutical

sector. In our next activity (6.2), we will analyse the implications of the engagement between

these sectors and the governance domains of science, market and public. Results from the

scoping exercises produced by WP1 (public acceptance), WP2 (scientific advances), WP3

(economic feasibility of GM animals), WP4 (animal welfare, health and environmental issues), and

WP5 (ethical implications) will be compared with the existing regulatory and governance

landscape in order to identify possible policy gaps.

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INTRODUCTION

PEGASUS is an integrated EU funded project in the Seventh Framework Programme that

aims to understand the socioeconomic, ethical and scientific implications of introducing

Genetically Modified (GM) animals and derivative foods and pharmaceutical products in the EU,

USA and India.

Work package 6 (WP6) will examine the policy implications of introducing GM animals in

the pharmaceutical and breeding sectors. The final output of WP6 will be a set of policy

recommendations taking into account the environmental, ethical, socioeconomic and research

evidence gathered by our consortium colleagues.

To maximise the usefulness of these recommendations, it is important to situate them

within the current political landscape. It is widely accepted that GMOs are a contentious topic in

which different key players interact at both national and international levels in pursuit of forward

their agendas. The GM animal policy process is situated within a system of multi-level governance

where multiple players and organisations at national and supranational level have a role in

determining what items are placed on the policy agenda at the different levels. In addition, other

factors such as the degree of policy implementation and the inter-state interaction at

international level will also play a role in shaping the political environment. For example, in the

case of GM plants the strategic role taken by ENGOs and media had a clear impact on public

opinion which forced the European governments to reject transgenic food and feed. In the case

of GM animals, the situation will be further complicated by concerns over animal welfare.

Therefore, an understanding of the current GM plant/microorganism debate and how it has

evolved is a necessary part of any discussion concerning future GM animal governance.

In this report (activity 6.1), we describe how the EU, USA and India have dealt with the

regulation of GMOs and their interactions at international level. The report focuses on the

identification of key stakeholders, the nature of their political interaction and their impact on

policy development not on the evaluation of the regulatory agencies’ use of scientific expertise in

risk assessment. We provide a summary of the existing policy context surrounding GM crops and

microorganisms that has produced the policy environment in which GM animal regulation will

have to adjust. Each of the case studies (EU, USA and India) have responded to their own

domestic needs. Due to the unique character of each GMO regulatory framework, our analysis is

organised around the 3 principles used by governments to deal with risk (risk assessment, risk

management and risk communication) taking into account the different threats and opportunities

that policymakers face when regulating GMOs.

In the context of the international landscape, we also explore the strengths and weaknesses

of each country when regulating GM animals. Some governments have started to develop specific

guidelines to regulate GM animals, although most applications are still in the early stages of

commercialisation. This implies a willingness to be more pro-active in the GM animal debate,

particularly when compared to the reactive position that characterised most governments in the

90s GMO crisis. Nevertheless, this behaviour is mainly at state level. With the exception of the

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OECD, none of the international organisations studied have GM animals (or even GMOs) on their

agendas.

The data for this report were gathered through internet searches, media stories and a

literature review of peer reviewed journals and policy reports. Having identified the relevant

multi-national bodies involved in GMO governance and established the outline of the regulatory

framework on GMOs for each country, we conducted 19 semi-structured interviews with political

actors (10 EU, 3 India, 1 USA and 5 international, see Appendix 1) with key roles in the policy

process. These actors were identified in part through their involvement in the risk assessment

procedure or management of the GMOs and in part through a ‘snowball’ approach through

recommendations by other interviewees. Unfortunately, we were unable to interview any

policymakers from FDA and USDA and instead obtained our knowledge of these regulatory bodies

and their roles through academic papers and internet searches.

We hope that this descriptive report will provide our PEGASUS colleagues with a general

context of the current regulatory framework of GMOs as well as some guidance on the

opportunities and constraints that need to be taken into account to ensure that realistic

conclusions from their work can be drawn. Finally, we are very grateful for the collaboration of all

the policymakers and scientists who were interviewed in this report that have helped to increase

our understanding of the complexities of GMO governance.

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CASE STUDY 1: EUROPEAN UNION

1. INTRODUCTION TO THE REGULATORY FRAMEWORK OF GMOs

Nowhere else in the world has the GMO debate reached the same levels of controversy as

in Europe, despite the fact that it was there where the first GM plant was developed. The

extremely successful campaigns in the 90s led by Environmental Non-Government Organisations

(ENGOs) with the support of the media resulted in public uproar against GM food whereas

recombinant medicines were left unaffected. The existing dichotomy between strong rejection of

food/feed applications and the acceptability of the pharmaceutical ones is apparent throughout

the European regulatory framework, becoming most visible at the risk management stage.

In the context of the current political environment it is unlikely that any significant

regulatory change on GM animal applications for food/feed purposes will take place. It remains to

be seen if the pharmaceutical sector will be able to absorb the economic costs involved in

maintaining the stringent co-existence measures needed to bring forward this promising

technology to the market.

1.1. GMO LEGAL FRAMEWORK

GMOs are regulated through a common centralised procedure that involves a set of legally-

binding regulations which Member States (MS) translate into their national legislation. Below is

the list of the most significant legal documents with regard to GMO governance (see Appendix 2

for a more complete list):

Directive 2009/41/EC on the contained use of genetically modified micro-organisms.

Regulation (EC) 1829/2003 on genetically modified food and feed.

Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms.

Regulation (EC) 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.

Regulation (EC) 1946/2003 on transboundary movements of genetically modified organisms. Directive 2009/41/EC specifically addresses the contained use of micro-organisms at the

initial stages of research. As in practice all GMOs start at the cell level in vitro, most member

states will classify the early work with animals and plants, carried out in confined facilities (i.e.

research laboratories), as contained use falling under this Directive and the corresponding

national legislation.

For food applications, Regulation 1829/2003 describes the general framework for the

regulation of GM food and feed with the aim to “ensure a high level of protection of human life

and health, animal health and welfare, environment and consumer interests in relation to

genetically modified food and feed, whilst ensuring the effective functioning of the internal

market”. It lays down the role of the EFSA (European Food Safety Authority), the centralised

community procedure for the regulation, and offers a “one window approach” in which crops are

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approved at the same time for food and feed applications (see section 2 for more detailed

information on the procedure).

The Directive 2001/18/EC regulates the intentional release of GMOs to the environment,

distinguishing between GMOs that are placed on the market (Part C) and the ones that will be

used for clinical and field trials (Part B). It describes a similar procedure to Regulation 1829/2003

but differs in that it has a stronger focus on environmental protection and the decision authority

procedure for applications, which will vary depending on the final use. Therefore, applications

under part B will depend on the Member States, with obligations to consult with the other

Member States. For part C applications, the involved authorities are EFSA, the National

Competent Authorities (NCAs) of the member states and the European Commission. Moreover,

unlike the Regulation 1829/2003, Article 31.7 (d) of the Directive foresees an inclusion of the

socioeconomic implications (advantages and disadvantages) of deliberate releases and placing on

the market of GMOs and allows scope for ethical considerations under Article 29.

Food/feed GMO application in the EU will follow a different legal procedure depending on

which legislation they are filed under. In all cases, the initial step will be the development of a risk

assessment by the MS which will be submitted to the EC. If the applicant uses Regulation

1829/2003, the EFSA will be involved in analysing the Risk Assessment (RA) and producing the

Environmental Risk Assessment (ERA), although member states are encouraged to produce an

independent ERA. However, if the application falls under the Directive 2001/18/EC, both EFSA and

the NCA (where the GMO will be released) will produce independent RAs and ERAs and will later

be compared. At all the stages the NCAs may comment in the RA or ERA, which need to be

considered in the EFSA opinion. The procedure under the Directive is so cumbersome that since

the Regulation 1829/2003 came into effect, not a single food/feed application has been placed

under the Directive 2001/18/EC. ENGOs and NCAs are very critical of this situation as in their view

they lack control in the final decision-making and fear that environmental protection will be

subjugated to market pressures1.

Regulation 1830/2003 focuses on the labelling and traceability requirements and

establishes a mandatory post-market monitoring system. In order to ensure the freedom of

choice among European consumers, labelling of products consisting or containing GMOs and of

food/feed produced from GMOs is mandatory in the EU, even if the GMO is no longer detectable.

Products from animals fed with GM feed however, are not required to be labelled as GMOs. The

traceability rules make it mandatory on the operators concerned, to be able to identify their

supplier and the companies to which the products have been supplied. Products that contain

traces of authorised GMOs that are adventitious or technically unavoidable need not to be

labelled as GMO or to be traceable as long as their proportion does not exceed 0.9%.

One of the most controversial issues surrounding the regulatory approach to GMOs in the

EU is the Zero Tolerance Policy (ZTP), for GMOs that are not (yet) approved in the EU, but are on

the market in other countries. Unsurprisingly, the economic hurdles involved in maintaining such

a low threshold (in practice this threshold is the detection level) throughout the whole food

1 http://ec.europa.eu/environment/archives/biotechnology/reports_culti.htm

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processing range, added to the low acceptance of GM food by the European consumer, has

limited the use of GMOs to the feed industry in Europe.

The above 3 pieces of regulation have recently undergone an external review. At the time of

writing, conclusions from these regulations were still not publicly available, although results from

the interim reports seem to indicate that stakeholders generally agree with the objective and

scope of the legislations but remain critical on their implementation.

In order to ensure that the level of segregation among GM crops and non-GM crops is

maintained, DG AGRI developed the Co-existence guidelines and set up the Co-existence Bureau

(CoB) for information exchange among MS. These guidelines are non-binding and provide general

principles for the development of national measures to avoid the unintended presence of GMOs

in conventional and organic crops.

With regard to pharmaceutical GM applications, their higher acceptability among European

citizens has been translated into a more product-based approach where different legislation will

apply depending on the final product. However, even though in theory the Directive 2001/18/EC

states that pharmaceutical applications, medicinal substances and compounds for human use that

contain a GMO (or combination of GMOs) are excluded provided that other Community

legislation requires consent prior to release, a specific environmental risk assessment in

accordance with Annex II and a monitoring plan (Art.5 and Art. 12) is required. In practice, none of

the relevant Community legislation covers the research and development phase, instead focusing

on the marketing phase. As a consequence all such deliberate releases are still subject to this

Directive.

Therefore, the simplest case would be when the manufacturing process is carried out

through a GMO but the final product is not a GMO (e.g. ATryn goat). The applicant would require

the approval of the NCA where the GMO is being developed but the final product would follow

the standard regulations in the clinical trial and marketing stages. The next level of complexity

would be where the process is carried out using a GMO and the final product is a GMO but is not

extractable or in other words, not released into the environment. In this case, in addition to the

approval of the NCA for the development of the GMO, the European Medicines Agency (EMA)

would be responsible for producing the ERA for the final product. But once in the market, the

product would not require additional controls except for the normal pharmacovigilance. The most

stringent scenario would be where the final product is not only a GMO but it is also released into

the environment. In this case not only would EMA be required to produce the ERA but also,

additional post-marketing monitoring would take place (although in the EU, medicinal products

are not labelled as GMOs).

Regulation 1946/2003 covers the transboundary movements of transgenics in accordance

with the Cartagena Protocol (CP) on Biosafey. Each MS is to define rules on penalties to deal with

non-compliance with this regulation and notification requirements are similar to the ones in

Directive 2001/18/EC. However, the scope of the Regulation is based on GMOs rather than

restricting the scope to LMOs (Living Modified Organisms) as stated in the Protocol.

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1.2. REGULATORY BODIES

1.2.1. EUROPEAN FOOD SAFETY AUTHORITY (EFSA)

EFSA was created in 2002 in response to a series of food scares that undermined European

citizens’ trust in the ability of their governments to regulate the food chain. Its mission is to

provide an independent and scientifically-sound opinion on health and safety issues relating to

food and feed supply. It is composed of a secretariat and 18 specific scientific panels including (as

expected), a GMO panel which is further subdivided into the molecular characterisation, the food

and feed safety and the environmental sub-committees. The panel will perform the risk

assessment of all the GMO applications within the EU and like other panels within EFSA, it will

also develop scientific guidelines and studies on topics of interest (e.g. fate of recombinant DNA

or proteins in the meat, milk or eggs of animals fed with GM feed).

In addition, the GMO panel members will spend a significant amount of time responding to

queries from numerous stakeholders. This was highlighted by both panel members who were

interviewed. They noted that it significantly decreased their efficiency because questions tend to

be highly repetitive and most of them are not directly relevant to their work (e.g. co-existence of

GM and non-GM crops). Furthermore, with the exception of the nutrition panel, the GMO panel is

the only one whose conclusions are regularly contested, which clearly undermines EFSA’s

authority as noted by Efsa scientist 1 who stated: “it is ironic that you have an organisation which

was meant to be independent and scientific and yet is being criticised for being exactly that”. For

example, they were asked twice to review their conclusion on the lack of harm of using antibiotic

marker genes in the development of transgenic organisms.

The GMO panel also holds a unique position among EFSA panels in that it remains isolated

from external stakeholders, including the applicants. The EFSA secretariat acts as the intermediate

link between the panel and the applicant. Although this is done to preserve the panel’s

independence and is viewed as a transparency measure, a panel member noted that a clearer

communication with the applicant would increase the efficiency of the whole process. This belief

is shared by the industry, where the only advantage seen in applying through the Directive being

their communication with the NCAs throughout the application process2.

It was generally felt from the EC that even though the EFSA (and specifically the GMO panel)

is a very young body, it is adapting very well to its needs. All policymakers interviewed also

sympathised with the critical environment in which the panel operates and fully supported their

decisions. There was also a consensus among interviewees that the risk assessment method

followed by the EFSA was fully operational and wide enough to minimise regulatory gaps.

The GMO panel has grown in proportion to the number of applications received. Starting

with 4 people it currently has 23 members. In addition, the panel has 40 additional scientific

experts to consult on an ad hoc basis. It was noted by Efsa scientist 1 that the EU currently has an

excellent pool of scientists who are aware of issues surrounding GMO risk assessment as a


17

consequence of the investment in research that the EU has made in this field. The level of

transparency and communication efforts on GMOs by EFSA with different stakeholders is

significant. Despite this, it was recognised by members of the GMO panel that the general public

is still unaware of EFSA’s existence and role.

1.2.2. EUROPEAN MEDICINE AGENCY (EMA)

EMA was set up in 1995 in order to harmonise the work from the different MS regulatory

bodies. Funded by the EU and the pharmaceutical industry the EMA is currently in charge of the

regulation of medicines for human use for certain diseases (e.g. cancer, AIDS, diabetes, etc.),

veterinary medicines intended to promote growth/enhance yields and all medicines derived from

biotechnology. Results from a recent evaluation praised EMA’s efficiency despite a growth in the

complexity of its work but warned that the system is reaching maximum capacity. Consequently,

the evaluation recommended some changes at committee level3. The EMA is a product-oriented

agency and the approval of products depends on a risk-benefit assessment, requiring the

applicant to demonstrate the safety, quality and efficacy of the final product, independently of

the process used for its development.

Within the 6 committees that compose EMA, GMOs would fit in the Committee for

Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for

Veterinary Use (CVMP), depending on the final user. In addition, they might be involved with the

recently created Committee for Advanced Therapies (CAT) if they are considered to fit the

criterion of advanced-therapy medicinal products (e.g. recombinant vaccines). Like EFSA, EMA will

also be answerable to queries from MEPs and other stakeholders although to a lesser extent than

is the EFSA. They have also produced their own reports based on needs, although never on GMOs.

Currently most of the GMOs in the approval process are microorganisms, which would fall

under the Gene Therapy Working Group (under CHMP) and might also involve CAT. These

therapies are in a very early stage of development (mostly in clinical trial stages), which make it

difficult to predict what kind of regulatory challenges they might face when they reach the

market.

Another less common type of GMO is a bioreactor or transgenic organism that produces

proteins with medicinal properties. In the EU, two animal bioreactor have been approved (see the

section 2.2 for more detail). In this case, if the product is for human use it would be the

responsibility of the Biologics Working Group (under CHMP) to create the scientific opinion. If the

product is for animal use, it would fall under CVMP. As stated in section 1.1, EMA would only be

required to produce an environmental risk assessment (ERA) if the bioreactor produces transgenic

products.

In any case EMA keeps a very low profile in the GMO debate, with discussions based solely

on technical/scientific matters. Indeed, EMA is only approached on a regular basis by the biotech

and pharmaceutical industries, patient organisations and medical doctors associations. The

3 http://ec.europa.eu/enterprise/dg/files/evaluation/final_report_emea_january_2010_en.pdf

18

differences between both scientific bodies were more evident when comparing their websites.

EFSA’s website is more transparent and easy to access for different stakeholders whereas EMA’s

website is highly technical and oriented towards industry. With regard to increasing transparency,

Ema scientist 2 explained “the general principle is that whatever is not commercially confidential

information, we disclose and this is what we are trying to do so we are increasing, as much as we

can, the level of transparency as EFSA does”. It is also interesting to note that none of the

questions written to EMA by MEPs have, to date, been related to GMOs.

1.2.3. DG SANCO

DG SANCO’s aim is to ensure consumer’s rights, food safety and health protection. It has

remained in charge of the GMO Regulations (1829/2003 and 1830/2003) since their entry into

force and it has recently been given the responsibility for the management of the Directive

2001/18/EC. Furthermore, EFSA commission of work on GMOs now comes solely from DG SANCO,

having been initially shared with DG ENV. This has been viewed positively by the GMO panel

members who were interviewed because DG SANCO has a tracked record of respecting the

scientific expertise and following EFSA’s final opinion. In fact, DG SANCO regularly attends EFSA’s

meetings to keep informed on the current state of the art but never interferes with the panel’s

decisions. A more controversial move has been the recent allocation of EMA to DG SANCO from

DG ENTERPRISE. As stated by A. Smith “Concerns are that the priority will shift further to public

health and provision of (cost-) effective medicines at the expense of supporting Europe’s position

as a centre for the scientific and commercial development of medicines for global markets.”4.

DG SANCO is, unsurprisingly, very cautious in its position on GMOs and has chosen to focus

on the practicalities involved in the management stage whilst refraining from taking positions on

either side. Interviewees from DG SANCO considered that the EU regulatory framework on GMOs

was well designed and based on international standards though in practice failing at the risk

management stage (see section 2.1 for more detail).

In addition to the meetings to approve specific GMOs, DG SANCO holds annual meetings

with NCAs to discuss issues encountered on GMOs or when there is an approval pending. These

meetings are known for their polarised opinions and difficulties in reaching an agreement. The

implementation of the Regulations is also different in each member state with different levels of

efficiency based on the Food and Veterinary Office (FVO) records. A Sanco policymaker

commented “there is a reasonable structure and I would say that generally the enforcement is

working alright”. Env policymaker however, specified that “it varies a lot. It is not necessarily

proportional”. DG SANCO also organises meetings with stakeholders such as industry associations

(i.e. EuropaBio) or ENGOs to explain the state of play and find solutions to their concerns.

4 http://www.icr-global.org/crfocus/2010/21-02/health-or-enterprise/

19

1.2.4. DG AGRI

The Co-existence guidelines are the only piece of legislation that is not under DG SANCO’s

jurisprudence. DG AGRI acts as a facilitator and a point of contact for all the NCAs. This is because

the guidelines are not binding, but draft coexistence legislation needs to be notified to DG AGRI

before being translated into national legislation. Agri policymaker explained that they hold regular

training workshops and annual meetings. These activities aim to increase the level of collaborative

work and to find common solutions to the issues surrounding GMO governance.

The DG AGRI has a very pragmatic approach to GMOs. Although Agri policymaker did not

deny the frustration of the EU’s approach to GMOs, the DG will work on ways to maintain the

European competitiveness in a global market dominated by GM crops. They have produced

reports analysing different economic scenarios if the EU looses access to non-GM soya (on which

the EU is dependent and unable to grow), maize and corn from the current markets in Brazil and

USA. In addition, as European breeders have been the most affected from the Zero Tolerance

Policy (ZTP), the DG AGRI has a strong voice regarding this policy whilst investing significant

resources in finding technical solutions to overcome this economic burden.

1.2.5. OTHER RELATED DIRECTORATES

Of all the DGs involved in the GMO debate, the DG ENV has been the most problematic.

Highly influenced by ENGOs, DG XI (as it was called before it included environment, consumer

protection and nuclear safety) emerged as the leading agency on the regulation of GMOs. It was

responsible for the move to a process-oriented approach for GMOs and the inclusion of the

precautionary principle in the Directive 90/220 which preceded the Directive 2001/18/EC (T

Bernauer and E Meins, 2003).

Following the setting up of the regulatory framework, the DG ENV held a strong anti-GMOs

position, systematically blocking all EFSA’s decisions. Neither did the situation improve internally.

As Rtd policymaker explained, DG ENV was an important actor in the failure of the Biotechnology

Steering Committee which was intended to improve the exchange of views among DGs in the 90s

and improve internal collaboration on GMOs. At the time of writing, no meetings have been held

for a year and a half as “you should have not your own agenda but your own opinion”.

Having played such a central role on the GMO governance, it is not surprising that DG ENV is

being approached mainly by ENGOs and biotech companies, and to a lesser extent by MEPs whilst

having little contact with scientists and producers. However, with the recent move of the

Directive to DG SANCO, DG ENV is no longer involved in GMO governance. Whilst Sanco

policymaker defended that this change was to increase organisational efficiency, all the other

interviewees saw it as a political move by the EC, to eliminate internal frictions and improve the

overall risk management procedure.

Therefore, one could reasonably expect that the highly political and polarised debates on

GMOs that have taken place for more than a decade would have hampered EU competitiveness in

this field despite the EU having a key role in the early development of GM technology. However,

research on GMO’s is still very strong and the EU has a global position in white and red

biotechnology. The situation is not that positive for green biotechnology, where European policy

20

has been strongly criticised by the scientific community (see the EMBO editorial “Recipe for

disaster”5 as an example). The EU though, has invested heavily in GM research since the 90s, with

DG RTD allocating around € 270 million albeit with a strong focus on the risks of this technology.

This bias is predictable as the budget for research is approved by consensus among member

states, where there has always been a strong anti-GMO fraction. Rtd policymaker recognised that

“looking at the benefits of GMOs has never been on the political agenda so far”. Unfortunately,

the results of this investment were that “GMOs are not more risky that conventional crops and it

costs us currently quite a lot of money not to use such technology”. A further consequence of the

politics surrounding GM technology is that most research is terminated at the stage of field stage

of trials because ENGOs destroy them6.This has deterred the European agricultural industry from

investing in this type of research.

Rtd policymaker stated that Europe had not focused enough on the benefits of this

technology, which can be significant, especially for the developing world. The interviewee

believed however, that there are other non-political problems which have hampered the

evolution of this technology such as the technical shortfalls associated with more useful traits (not

correlated to a single gene), lack of direct benefit to the consumer and the fact that due to the

EU’s privileged economic situation, there is no real need to adopt GMOs.

The involvement of DG TRADE in the GMO debate is another example of the consequences

of the European policy towards GMOs. It was indirectly brought into the governance of GMOs as a

result of issues relating to asynchronous authorisations, illegal trade and in particular, the WTO

dispute.

Asynchronous authorisations and resulting adventitious presence of unauthorised GMOs

are becoming increasingly frequent and present as a big economical hurdle for the EU. Despite

efforts to reshape the policy from both DG TRADE and DG AGRI, the political environment is

unlikely to change. With regard to illegal trade, Trade policymaker was confident that the current

regulatory framework was efficient, especially when compared with the existing equivalent in the

US (see chapter 2). However, GloFish (fluorescent Zebrafish by Yorktown Technologies) has

already entered the black market in the UK, as it is legal to import it from the USA (where it is

commercialised) providing you already own it. Trade policymaker clarified however that the

situation is under control as several MS had been asked to stop the imports.

Finally, in response to the EU’s de facto moratorium on GMOs, in 2003 USA, Canada and

Argentina brought the case to the World Trade Organisation (WTO). The EC was accused of taking

agricultural protectionist measures that caused trade barriers. DG TRADE had to defend the EC’s

position in what became the longest dispute in WTO history (see section 10.3.3 for details).

5 Recipe for disaster (2003) Nature Biotechnology Editorial. 21 (5)


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2. THE REGULATORY FRAMEWORK IN CONTEXT

The GMO debate in Europe has been covered from every imaginable angle. It has been

interpreted as an example of successful ENGO campaigns against capitalism. It has fascinated

social scientists and repulsed molecular scientists alike. Despite the different opinions, one of the

few points of agreement is that the current European regulatory framework is more in line with

the public’s perceptions of risk than with the scientific definition of risks. As a result, transgenic

medicines (which have largely remained outside the ENGO radar) are being regulated through a

more product-based approach (although they might still require an ERA) and the comitology

procedure is fully operational. GM food on the other hand, is being regulated through a strict

process-based approach, requiring complete segregation throughout the production chain and

mandatory labelling. Certain MS remain unconvinced of the risk assessment approach by EFSA,

which has resulted in the EC taking the final decision on each GMO approval until this day.

The comitology procedure under the Regulation will start after the applicant (or notifier)

submits an application to any of the NCAs from the EU. The NCA will forward the application to

the EFSA and once it is considered complete (i.e. it has all the required documents), the GMO

panel at EFSA has 6 months to perform the RA. EFSA’s official opinion will then be forwarded to

the EC. Within 3 months, the EC is expected to produce a draft decision which will be discussed in

the Standing Committee and a majority is needed to approve or reject the application. The

procedure is very similar for the Directive although in this case, the NCA where the notifier

submits the application will produce an independent RA (which will later be compared with EFSA’s

RA).

As Env policymaker stated, the uniqueness of the GMO controversy is based on two facts

“one, it is a very technical topic, and secondly it is emotionally-charged”. Furthermore, the EC

remains a regulatory state with no democratic accountability as it is a supra-national state (T

Bernauer and E Meins, 2003, S Borras, 2006). As a consequence, even though the EC could bring

MS to the European Court of Justice, it has focused its competencies on policy creation rather

than implementation (KL Kollman, 2003). It has been argued that the EU has made itself

approachable to other political actors (e.g. ENGOs, consumer organisations) as a means for

increasing its effectiveness as well as compensating for its lack of accountability (G Skogstad,

2003). Within this unique environment, it is not surprising that ENGOs have been able to influence

the GMO agenda and that through DG ENV (or DG XI at that time), they have played such an

important role in the development of GMO regulations (T Bernauer and E Meins, 2003).

2.1. FOOD AND FEED SECTOR

There is an extensive academic literature describing the factors that influence the approval

of GMO dossiers for feed/food applications in the EU. The debate is extremely polarised and the

failure of the EC to keep the system operable has left the EC legally ‘exposed’ as was shown in the

WTO dispute.

Member states have been inconsistent in their behaviour concerning green technology. As

described by J. Beringer in the DG RTD Review of the Results on GMOs: “the success of the anti-

GM lobby is clearly demonstrated by the fact that in much of Western Europe governments have

22

appeared very ambivalent. They have invested in biotechnology and promoted its advantages,

while at the same time they have tacitly accepted delays in the regulatory system for marketing

GMOs to ensure that their commercialisation for agriculture has been impeded” (C Kessler and I

Economidis, 2001). Therefore, countries such as France and Germany which according to Rtd

policymaker have strongly invested in GM technology recently banned the renewal of MON810

despite favourable opinion from the EFSA and the lack of adverse effects after being cultivated in

their territories for years. Ironically, MON810 is still being cultivated (in order to stop the

cultivation the Commission, an administrative body, would have to scientifically challenge EFSA’s

opinion) but unlike other approved GMOs, is currently not being monitored.

In addition, due to the high accessibility of the EC by interest groups, the European GMO

governance has been shaped by the interactions among numerous stakeholders. ENGOs are very

active in this area with Greenpeace and Friends of the Earth acting as the main players, and to a

lesser extent, the Green 10. They all campaign to declare the EU a GM free zone and have had a

key role in shaping the regulatory framework through public demonstrations and mobilisations in

the 90s. The ENGOs’ success in the EU is greatly due to their ability to position themselves as part

of the general public7, taking advantage of the distance between Brussels and European citizens.

Their level of activity is still high, and activities include writing to the commissioner criticising

EFSA, attending EFSA and DG SANCO meetings and responding to public consultations by EFSA. In

addition, Sanco policymaker stated that these interest groups regularly check for GMO presence

in the supermarkets.

Industry (as expected) is also active in the area, but their level of communication is

different. EuropaBio holds regular meetings with EFSA to discuss issues surrounding risk

assessment which are seen as very productive by both EFSA scientists. Nevertheless, the

interviewees were also aware of the industry’s agenda and as Efsa scientist 2 noted “managers of

the companies are people looking at the pounds and dollars and are driven by commercial

interests”. The other contact is through the individual applicant, who will generally first contact

DG SANCO when they plan to file an application. The biotechnology industry, however, maintains

a very low profile and rarely communicates to the public.

Consumer organisations are also key players in this debate although their activities are

geared toward the review of EFSA’s applications. They are very interested in finding differences

among dossiers from different countries as the RA is very similar worldwide (based on Codex and

OECD guidelines, see section 10). Thus, there should not be significant differences. Ironically, DG

SANCO (DG in charge of protecting consumers) is not approached by consumer organisations

regarding GMOs.

Producers are less active in this area but will contact DG SANCO with regard to labelling

requirements. Scientists also approached DG SANCO, EFSA, EMA, DG AGRI and to a lesser extent,

DG ENV. Obviously, DG RTD also has a strong linkage with scientists as well as industry but less so

with lay audiences because its language tends to be too technical, including its communication

7 e.g. Greenpeace’s website states: “governments that support them are still trying to force their inventions on us,

purely for commercial gain” or “gain intellectual property rights over our food”

23

packages (booklets summarising the conclusions of the research carried out on GMOs which are

too technical for lay audiences).

Finally, MEPs are very active in this area; they contact DG SANCO, DG AGRI, DG ENV and

EFSA on a regular basis with a wide array of questions, such as “all aspects of the legislation or is it

possible to ensure efficient control, the limitation of the analytical methods, guidelines, we

develop new guidelines for the risk assessment how has it been developed, was it transparent

enough, or is the public being informed, what will be the consequences” (Sanco policymaker). As

stated before, their opinions tend to be much polarised. Notably, Rtd policymaker believed that

DG RTD was the only DG which did not receive many questions from MEPs on this topic and

regretted that it was not approached more by other DGs as “we are not designing projects to

show the benefits of GMOs but designing projects to show if there are any benefits and if there

were any benefits then what benefits, how large are they and this type of thing”.

2.1.1. Risk Assessment

Both EFSA and DG SANCO operate at EC level a complex regulatory framework in a

polarised ‘hostile’ environment. EFSA is in charge of developing a centralised science-based risk

assessment whereas DG SANCO is in charge of the risk management stage. In addition, both

bodies are also exposed to a high number of interests groups, notably ENGOs and biotech

industry. This persistent exposure has “paralysed” DG SANCO, which is unable to take any position

without being attacked by stakeholders groups and certain NCAs. It is therefore not surprising

that the GM food/feed comitology procedure has remained from the beginning the only non-

operational procedure within the EC.

The Risk Assessment (RA) is the cornerstone of GMO governance and as seen in section

1.1.1, it remains the responsibility of the GMO panel in EFSA and/or the NCAs. It was in response

to the public outcry on GMOs that the EU moved from a relaxed governance of agricultural

biotechnology to the development of the current highly stringent regulatory framework (T

Bernauer and E Meins, 2003).

It has been argued that scientists have a different perception of risk from the general public

(BA Van Asselt et al., 2008). The governance of uncertainty is complex and has been identified by

some as the core problem of the GMO governance: “any regulatory reform is doomed to fail if the

uncertainty paradox is not recognised, let alone addressed” (BA Van Asselt et al., 200). Indeed,

Efsa scientist 2 confirmed that “uncertainties are a crucial point in the scientific evaluation. We

are keen on seeing whether we have covered that issue completely”. ENGOs and MS authorities

noted in the Directive’s review (interim report) that “EFSA is becoming better at acknowledging

scientific uncertainty, but that more still needs to be done”8. Efsa scientist 1 commented on the

NCAs’ positions: “it depends on what drives them. If science drives them, then I think they respect

EFSA’s opinion. If the politics drives them, they just ignore EFSA opinion, so it depends on which

way the competent authority is operating”. Therefore having a science-based risk assessment

forces NCAs with strong anti-GM opinions to use science to defend their position. However, there


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are also cases where NCAs are science-driven but due to the politics within their own state, their

opinions are being overruled, as in the case of France or Italy. It was also noted by Efsa scientist 1

that ENGOs, which remain strongly critical of EFSA’s scientific opinions, will never bring new data

to support their case and focus instead on identifying differences between GM and non-GM crops

in the reports, without taking into account their level of statistical significance.

This level of uncertainty results in bottlenecks in certain areas of the risk assessment

procedure such as the comparator crop that is used to demonstrate substantial equivalence.

There are member states such as Austria with a strong organic industry which demand that

organic agriculture be used as a comparator (internationally this is the one used in traditional

agriculture). Another example is allergenicty as Efsa scientist 1 explained “you can find somebody

who is allergic to anything...You can never say no, there is no risk of allergenicity”. This creates

endless discussions as highlighted by Efsa scientist 2, “if a member state claims that we have not

satisfactorily answered questions on allergenicity then it turns out that member state does not

accept our way of assessing allergenicity, then you can discuss until you die and you will never

reach an agreement”.

Another common area of disagreement is the environmental risk assessment (ERA) as it is

carried out centrally by EFSA (and sometimes also by NCAs), which certain MS claim should be

specific to their ecosystems if they are to approve it. In addition, environmental monitoring is also

challenging because it is difficult to resolve what should be monitored. Efsa scientist 2 reported “it

is very difficult, if not impossible, to have a proper monitoring system and you can only use it, let’s

say, for reassurance purposes. You should not have it if you are not sure that the GMO is safe. If

you are not sure, you should not release it on the market”. This is especially challenging for

environmental monitoring as noted by Efsa scientist 1 who found that some environmental

monitoring plans (e.g. Bt crops) are based on “hypotheses because we have not identified what

harm may be caused by the crop” after more than 10 years of cultivation.

To add another layer of complexity, certain MS have asked that socio-economic aspects be

considered in the risk assessment in order to “allow MS authorities to address some of the

political issues associated...have also acknowledged that explicitly including socio-economic

concerns in decisions on whether to authorise a GMO for cultivation can have negative effects9”.

At the time of writing, DG SANCO was producing a report assessing this possibility. All EC

interviewees however, are of the opinion that the RA should remain science-based and were

sceptical that the inclusion of these aspects would facilitate the final decision.

As expected, the completion of the assessment is very time-consuming. EFSA’s interviewees

named as their main logistical drawbacks: the irregularity of meetings, the time dedicated in

answering all the stakeholder’s questions and the incompletion of the submitted dossiers. On the

later point, Efsa Scientist 2 noted that “the industry says ‘well, we don’t understand the question,’

while in fact I think they do understand the question but they don’t want to answer it or they do

not want to perform experiments that we suggest”. Industry on the other hand, remains critical of

EFSA’s delays. In fact, the Directive review stated that EFSA’s inefficiency is the only point in

common among the different stakeholders including industry, NCAs and ENGOs8. Criticisms


25

include that the EFSA’s guidelines are too vague, the RAs are produced sequentially rather than in

parallel and that the time watch that is used to time the process of the application is only

activated once the panel considers the information satisfactory rather than when they receive it.

These comments are also present at state level. A UK report on the state of GMOs industry

reported that despite agreeing with the principles of the regulatory framework there were

concerns regarding the economic effects on the UK market due to “the rate of EU approvals for

GM products, coupled with the absence of any tolerance for low levels of unauthorised GM

material”10.

2.1.2. Risk Management and Communication

Once the RA is done (through the Regulation or Directive) EFSA will submit its opinion to the

EC. The EC will subsequently draft a decision which will be submitted to the Standing Committee

on the Food Chain and Animal Health (if it follows the Regulation) or the Regulatory Committee (if

it follows the Directive). Both Committees will have representatives of the NCAs for each MS. DG

SANCO and DG ENV have traditionally been involved in these meetings which according to the

interviewees, can prove difficult in terms of reaching an agreement among different stakeholders.

Env policymaker recognised that “we are not seeking to ensure any, to achieve any consensus

between them. It’s a lost battle from the very beginning” and explained that at the meetings with

the NCAs “we go there with a proposal and we discuss it with them, we even do common drafting

so we open the laptop, we put the text on the screen and member states and we go article by

article”. However, so far, none of the GMO proposals had received a qualified majority in favour

or against at this stage.

Based on the Regulation/Directive the NCAs should give science-based reasons to vote

against the approval of a GMO. In practice however, certain NCAs have been criticised for being

too political as Efsa scientist 2 noted “you can see that member states who are against a certain

GMO application they use political arguments, like there is consumer concern full stop, without

explaining what and why and how it has been measured”. Indeed, the politicisation of science in

the GMO comitology procedure has been one of the main reasons for its inoperability. Other

common criticisms concerned the fact that GM crops will contaminate non-GM crops which is a

co-existence issue related to management not science. The arguments for rejecting the approval

of a GMO were noted to be somehow predictable, as Efsa scientist 1 explained “we’ve got to

know the people in the competent authorities quite well. You know where they are coming from.

You know the sorts of comments that are going to come from the different countries”.

If no decision is reached in the Committee, the next step for the application in both

regulations is the Council of Ministers. All GMO applications for food/feed have gone through this

step as an agreement (to vote for or against its approval) has never been reached at Committee

level. At the Council the level of polarisation still remains strong among MEPs. As expected, MEPs

from states that are anti-GM have the strongest views. There are however, MEPs that will be

supportive of GM technology because they see that they should ensure sustainable development,

and sustainable development includes economic development. The case of Germany can be used

10 http://www.defra.gov.uk/environment/quality/gm/crops/documents/foodmatters-defra-fsa-1308.pdf

26

as a good example to illustrate the complexity of the debate. Interviewees said that MEPs from

states such as Austria, Germany, France, Greece and Italy have showed their concern on GMOs

but at the same time, MEPs from UK and also Germany have written questions to DG SANCO in

favour of the adoption of GMOs. Interestingly, Spain, where most of the GMO cultivation in

Europe is occurring, remains quiet in this debate displaying only a few actions such as the

objection to France’s decision to ban MON810 (also cultivated in Spain).

As an agreement has never been reached at the Council of Ministers, the EC has been

forced to take the ultimate decision. Because the EC uses EFSA’s opinion as the scientific

authority, GMOs have been approved even without a qualified majority. This is a very delicate

situation because the EC is a technocratic body without democratic powers. It has been further

complicated by the fact that, even after the approval of a given GMO, certain states will try to

stop its cultivation through the “safeguard measure” which allows MS to ban GMOs if they can

scientifically prove new risks regarding the environment or human health. According to the EFSA’s

interviewees, none of the safeguard measures claimed had so far had any scientific validity. A

good example of the politics involved in GMO approval is the Portuguese government which

declared the safeguard measure for Madeira. This measure was developed to ensure that farmers

from that area would not be able to grow Bt maize (MON810). However, Bt crops are not needed

in Madeira as there is no prevalence of corn borer (the target of Bt toxin). It was a political move

to declare the area GM-free and market Madeira’s agricultural products and wine.

The Zero Tolerance Policy (ZTP), where no adventitious presence of unauthorised events is

allowed is another key factor that renders the procedure non-operational. The ZTP is seen as a

political rather than a scientific measure and too costly to implement without any added safety

for the consumer or the environment. As one of the Efsa scientist 1 stated “if it was revealed that

other aspects of food safety were not being considered independently by scientists but were being

considered by politicians and politicians were making decisions on food safety, there would be

public uproar and people would ask why do you have EFSA if the politicians are making political

decisions which override EFSA’s opinions. But, of course, this is GMOs”.

The resistance of certain member states to the cultivation of approved GMOs has had

external consequences such as trade disruptions and also internally, as noted by Efsa scientist 1:

“it must be incredibly frustrating for farmers in the South of France who are having to spray

insecticides for the corn borer control, when they see their neighbours just over the Pyrenees

[Spain] growing Bt maize and getting all the economic advantage”. Farmers associations in Italy

and France have, in fact, started to take legal action against their governments for not allowing

them to cultivate GMOs.

All interviewees agreed that the main consequences of the failure to reach a consensus on

GMOs (and the restrictions involved in their import/cultivation) were the loss of European

competitiveness (DG AGRI is currently producing a report to quantify the economic losses) and

the increase of international tensions, particularly with the USA. Indeed, trade issues due to the

ZTP resulting from the backlog in approving events already on the market in other countries

(asynchronous authorisations) have caused the EU to block the entrance of agricultural imports.

Taking into account all these issues, it is not surprising that there have been several

attempts by the EC to make the comitology procedure operational. In fact, one of the issues

27

covered by Barroso’s political guidelines (following his election as the EC president) was to

advocate more freedom for MS on GMO cultivation matters. The Netherlands had already

proposed that each MS should have the hegemony to decide whether or not it can cultivate

GMOs in its territory. Consequently, in July 2010 DG SANCO produced its interpretation of

Barroso’s guidelines by adding a new article in the Directive 2001/18/EC which will allow MS to

ban cultivation of GM crops in their territory without using the safeguard measure. It should be

noted though that they still need to inform other MS of their decision and show respect for the

internal (EU single market) and external (WTO agreements) trade obligations. Efsa scientist 2

commented on this decision “in a way this is a defeat but on the other hand, it could end this

blockage on GMOs in Europe, which is important as well”.

Unfortunately, the EC remains deficient with regard to risk communication to lay audiences.

As stated in the Directive interim report, after more than 10 years on from the GMO crisis, ENGOs

are still the sole stakeholders to have regular contact with the public on this topic11. This fits with

the general ethos in the EC (and MS) focusing only on risks and ignoring the benefits. As stated by

Sanco policymaker “as long as you only look at risk you are always on the defensive side”. Env

policymaker however, thought that GMOs are hard to communicate stating that “we have not

been very active ourselves in propagating a lot of the work going on because sometimes it might

also backfire”. Finally, Sanco policymaker defended the EC’s position saying “it is very difficult to

communicate as an institution…we communicate on how we manage the legislation, we don’t

communicate as such on the GMOs”.

2.2. PHARMACEUTICAL SECTOR

In contrast, the regulation of medicinal GMO products in Europe does not differ from the

rest of the world. Science dominates over politics and product approvals attract no attention from

ENGOs or media. The comitology procedure is healthy and fully operational and EMA spends little

time responding to stakeholders’ queries when compared to EFSA. In fact, the EU enjoys a globally

privileged position in this type of technology.

This global position is clearly correlated with the higher level of acceptability of red

biotechnology by the European public due to the clear benefits but also to the private and public

investments on this field. Biotechnology, for example, appeared as one of the key enabling

technologies of the 21st century to support the Lisbon Agenda that aimed to transform the EU in a

knowledge-based economy.

The number of interest groups that approach EMA and the EC with regard to medicinal

GMOs is significantly less than the food/feed GMOs equivalent. Moreover, EMA is approached

mainly by scientists and the biotech industry and to a lesser extent by medical and patient

associations. Therefore, the lack of polarised views as an influence on the comitology procedure

in addition to the public support for these applications, have limited the politicisation of the

regulatory system.


28

2.2.1. Risk Assessment

EMA’s remit is only on product safety and efficacy through a cost/benefit approach. It does

not take into account the GMO status except to decide whether an ERA is needed as part of the

approval dossier.

As stated in point 1.1.1, there are different pathways for a medicinal product that is a GMO

or is produced by a GMO. For cases involving microorganisms (e.g. viral factors, recombinant

bacteria, etc), there was general agreement among EMA’s interviewees that the existing

regulation was not appropriate. This is corroborated by the DHMP Gene Therapy Expert Group

Meeting Report (17-18 June 2004) which states “Members of the GTEC noted that the clinical use

of GMOs was clearly not primarily envisaged when the directives were drafted. The regulations are

complex and interpretation of the directives into a medical environment has been and remains a

problem”. Biotechnology industry is predictably, very critical of the regulation and as Ema scientist

1 pointed out “it’s a bit of added complication for the manufacturer to get the product to the

market but not at the benefit for patients”.

A more significant consequence of the GMO legislation is seen at the clinical trial stage.

Both Directives (2001/18/EC and 2009/41/EC) are expected to be translated into national

legislation. However, MS need to decide whether to interpret a clinical trial as contained use

(under Directive 2009/41/EC) or environmental release (under Directive 2001/18/EC). For

example, the UK and Italy apply the contained use regulations, Germany and the Netherlands the

deliberate release and France has two separate bodies: one for the development, production and

storage, which is considered contained, and one for the administration of the GMO, which is

considered release. As a consequence, the GTEC report (14-17 June 2004) stated “a practical

consequence is that the weight of procedural requirements and the impact on the overall clinical

development plan and patient’s management has resulted both in biasing the choice of the

Member State in which a proposed clinical trial is performed and in that many industrial

developers of this technology are choosing non-EU areas for their trials (especially the USA)”. The

biotech industry has indeed asked EMA to give guidance on how clinical trials should be

performed when involving GMOs. EMA’s interviewees though, believed that the Agency lacks the

authority to do this as it would interfere with the state’s sovereignty.

Another result of the “GMO crisis” spill-over to the pharmaceutical sector is seen on the

requirements for transparency (data in the ERA should be available to the public) which are

incompatible with the confidential status of medicinal dossiers. As the Ema scientist 2 stated “you

have to delete all the commercially confidential information and when you do that, you are left

with very little information”.

With regard to the regulation of bioreactors, as stated in 1.1.1 these would fall under the

Biological Working Group (if aimed for human use). Biopharming was seen as a very promising

technology in the 90s and indeed, EMA produced scientific guidelines for plant and animal

biopharming. There have been however, some technical hurdles which have limited the access of

bioreactors to the market. One of the main problems involves their release to the environment as

29

these organisms produce proteins with a biological effect on humans and/or other animals and

therefore, require containment facilities to ensure complete isolation (which has proven

challenging with plants) (A Spok, 2006). Ema scientist 3 also explained that other issues specific to

animals concern the variability of expression among individuals, the pathogen safety, the

impurities related to the host and the long reproductive cycles of animals.

In spite of such hurdles, the ATryn goat (from GTC Therapeutics) was approved by the EMA

in June 2006, followed by Ruconest (from Pharming Group N.V.) in June 2010. With regard to the

specific risk assessment process of ATryn, Ema scientist 1 explained that EMA struggled to

understand how to construct the animal, maintain it and test it. They had to go to some of the

veterinary experts in the field but “once you get into the milk or whatever, excretes, containing

the biological active substance, then it is standard for us”. In fact, due to the narrow remit of EMA,

there is a need for stronger collaboration between EMA and EFSA if biopharming is to move

forward.

In addition to scientific aspects, Ema scientist 1 also mentioned that in one of the

applications they wondered about ethical concerns regarding the use of animals “but this was not

a big theme in the review of this product”.

2.2.2. Risk Management and Communication

EMA interviewees claimed that at the NCA’s meetings it is never a cause of concern

whether a product is GMO or not. The meetings were described as scientifically-oriented and

following the standard comitology procedure. It is also worth mentioning that the NCAs for

food/feed are different from the NCA’s from pharma and there was a feeling amongst EMA

interviewees that the communication between the different NCA’s in each country was deficient.

Despite the initial rejection of the ATryn goat in February 2006, it was finally approved four

months later as “CHMP concluded that the benefits of ATryn outweigh its risks”12. Ema scientist 1

stated that the rejection had nothing to do with the product itself (derived from a GMO) but with

the clinical trials presented for the approval. This approval was received as a breath of fresh air by

the sector and indeed, it was argued that EMA’s approval was a sign of support to this technology

(C Smith, 2006).

At risk communication level, EMA is not as approachable as EFSA and keeps its

communications highly technical. Medical and patient associations are the only stakeholder

groups at the consumer’s end that have regular involvement with the Agency. However, it is

important to take into account that there has never been a need to communicate to lay audiences

regarding GMO issues. EMA interviewees believed that EMA took on board the opinions of all the

stakeholders and confirmed that they were never required to communicate on GM medicines.

12http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_00

0177.jsp&mid=WC0b01ac058004d5c1&murl=menus/news_and_events/news_and_events.jsp&jsenabled=t

rue

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3. GM ANIMALS IN THE EUROPEAN UNION

Although GM crops have not been in the headlines for a while, the rejection of green

biotechnology remains strong according to the last EuroBarometer results. Similarly the recent

ban by France and Germany on the cultivation of MON810 clearly indicates that a cautious view

should be taken with regard to the introduction of GM animals in Europe. This was confirmed by

all European interviewees who remained sceptical regarding the possibility of GM animals

entering the food chain, although they were more optimistic regarding the application of GM into

the pharmaceutical arena (with the exception of Agri policymaker).

There are numerous practical challenges that make the introduction of GM animals in the

EU difficult. Some of them concern the expected impact on the arrival of GM animals in the

market, such as the low efficiency of the techniques or the variability of the construct expression

in each individual (although scientific advances have significantly reduced these shortfalls). Others

will have an effect on the risk assessment such as the long reproductive cycles of animals. There

are also issues surrounding gene flow between GM animals and its wild counterparts (e.g. pigs

and wild boars). However, the most important limiting factors are ethical concerns due to the

closeness of humans with animals, and cultural beliefs (e.g. Muslims will not eat GM animals with

pig’s genes). As noted by Efsa scientist 1 “one of the things when you are evaluating a GMO is that

you get an element of change…changing a plant could be more acceptable than changing an

animal...what is an acceptable change depends on where people come in the spectrum, which is

very cultural”.

With regard to the regulatory framework, it was believed by all policymakers interviewed

that the GMO regulation was sufficiently broad to enable consideration of GM animals with

changes only required at the risk assessment stage. Following a mandate from the Council, EFSA’s

GMO and animal welfare panels are currently working collaboratively to produce guidelines for

the RA of GM fish and GM insects. In addition, EMA is currently revising the guidelines developed

in 1995 on the use of animal bioreactors to take into account current scientific advances.

Interestingly, with GM animals there is an expected increase in the collaboration between the

EMA and the EFSA on husbandry aspects as the EMA’s remit is only on the efficacy of the final

product. Despite the different governance between EMA and EFSA, both scientific bodies were

confident that the collaboration would be a positive experience and in fact, they already

collaborated on the development of guidelines for plant biopharming. There is some risk

however, that EMA will start receiving more attention from certain stakeholders with regards to

animal welfare issues (especially when collaborating with EFSA), although this was not the case

during the approval of ATryn.

The Directive 2001/18/EC is able to take into account ethical considerations on GM animals

and here the EC can call on the European Group on Ethics (EGE). This group have already issued

an opinion on cloning which raises concerns similar to those of lay audiences. It is also important

to take note that following the Lisbon Treaty animals are considered “sentient beings” - which

means they have obtained legal status.

31

With regard to the risk management of GMOs, there is a clear change of behaviour within

the EC from the 90s with the EC now taking a more pro-active approach. For example, the

commissioning work to EFSA is currently done by DG SANCO whilst before it was shared between

DG SANCO and DG ENV and the governance of the Directive 2001/18/EC from DG ENV to DG

SANCO. This is expected to increase the latter’s operational power although Env policymaker

noted it also carries some disadvantages because as “the institutional brainstorming is reduced, so

the inter-service consultation is now shrunk”. The recent proposal on cultivation based on

Barroso’s guidelines could also be seen as a step towards making the system operational although

it is not clear whether GM animals would follow the same procedure. It was also noted by some

interviewees that within each MS the NCAs that would assess GM animals would not differ

significantly from the ones involved in GM plants. This would minimise institutional gaps but

pharmaceutical and food applications would still be under different NCAs. However, the evolution

of any hypothetical GM animal debate may present problems to the EU if its EU civil servants

remain isolated from European citizens. Rather than focusing on the interest groups that claim to

represent the public’s opinion, it may be that the EU and its individual governments will need to

increase risk communication strategies towards lay audiences.

With regards to the non-governmental groups that might influence the GM animal agenda,

some significant changes are expected, particularly as the animal welfare organisations are taking

a lead role. Green activists such as Greenpeace or Friends of the Earth would therefore be

competing for media attention and access to funding with welfare groups. Interestingly, biotech

industry does not seem to show any significant interest in GM animals. The Sanco policymaker

noted that none of EuropaBio’s members are working with GM animals, at least on the food and

feed side. The breeding industry has not approached the EC although it was noted by some

interviewees that this was at a very early stage and only some GM animal applications are at the

market stage. Finally, another possibly significant factor is the contribution of the European

Parliament where some MEPs have a strong anti-GM animal ethical position.

The policymakers interviewed were cautious about the future of GM animals because their

expected arrival in the market in the 90s had never materialised. Furthermore, as Rtd policymaker

noted “you might be able to do research, but you might end up with a marketable product? I

doubt that very much”. When comparing pharmaceutical and food/feed applications, there is a

shared belief among interviewees that pharmaceutical applications are more realistic and in fact,

a pharmaceutical application (ATryn goat) had already been approved for commercialisation and

one has received the initial authorisation by EMA (Ruconest). Nevertheless, DG AGRI opposition

to animal biopharming for fear of economic losses in the meat sector are a major drawback for

the development of this technology. Indeed, the effectiveness of containment measures was the

major concern of both policymakers and scientists alike.

In conclusion, the European GMO regulatory framework is in theory fully operational and is

able to include GM animals. Indeed, the regulation has already been used for the approval in 2006

of ATryn (transgenic goat) and Ruconest (transgenic rabbits). There is however, a need for specific

guidelines for the risk assessment and some amendments to be made to tailor the Directive to

medical applications (see section 2.2.1). The possibility of GM animals entering the European

food/feed market is currently negligible because of the low levels of public acceptance and the

ethical/cultural values concerning transgenic animals. However, as the GM plan experience

32

shows, Europe will not be able to avoid the arrival of GM animal. Significant trade disruptions are

to be expected along with possible public hostility if a GM animal escapes the EU monitoring

system (GloFish has already been found in countries such as the UK).

Finally, there is still concern that the EC and its member states will not be able to cope with

a second GMO debate if they do not improve their levels of risk communication and challenge

activists’ self-imposed role in Europe as the “GMO sentinels”. As the Defra-FSA 2009 report

concluded “it might be timely to inform consumers of the issues surrounding GM and non-GM

supply chains”13.

13 http://www.defra.gov.uk/environment/quality/gm/crops/documents/foodmatters-defra-fsa-1308.pdf

33

CASE STUDY 2: UNITED STATES OF AMERICA

4. INTRODUCTION TO REGULATORY FRAMEWORK

The USA has a unique regulatory approach to GMOs, adapting existing legislation to assess

the safety of GMOs. This decision was further supported by a report of the National Research

Council, which stated that transgenic methods of plant breeding pose no new categories of risk

(NRC, 1989). Consequently, the US regulatory authorities consider GM food as any other novel

food and focus solely on the safety of the final product independently of its process of

development. This product-based approach has been the centre of numerous debates with

opponents criticising the lack of a precautionary approach to GM applications on one side, and

proponents praising its scientific rigour when compared to other regulatory approaches on the

other side.

In reality, due to the fast rate of scientific advance in this field, GMOs have a ’short

commercial life’ and the ability of companies to make profits depends largely on their ability to

get their products quickly to the market (S Zarilli, 2005). There is no doubt that the regulatory

framework in the US has benefited the agricultural biotechnology industry, becoming the World’s

biggest GM crop exporter. Nevertheless, US agencies only regulate certain aspects of GM crops

(e.g. EPA will regulate the effects of Bt crops but not herbicide-tolerant crops). This approach

contrasts with the widely adopted Codex guidelines on recombinant food (including in India and

EU states) that recommend assessing the effects of the GMO as a whole. Consequently, the

departure from international standards by other countries has had significant economic effects on

US agricultural exports.

The existing trade disruptions and the higher resistance among American consumers to the

acceptance of transgenic animals have clearly influenced the US GMO framework. Indeed, the

government has developed a new approach to assess GM animals, adopting for the first time the

Codex guidelines on recombinant food.


The US has not created a specific set of regulations for GMOs but instead has regulated them

under existing legislation. There are 3 bodies involved in GMO governance with very specific

remits based on their statutory authority, although they all take into consideration the National

Environmental Policy Act (NEPA) and the Endangered Species Act (ESA).The legislation that each

agency relies on to regulate GMOs is as follows (see Appendix 3 for more detail):

U.S. Department of Agriculture (USDA):

For GM plants:

Plant Protection Act (PPA) Plant Quarantine Act (PQA)

For GM animals:

Animal Welfare Act (AWA)

34

Federal Meat Inspection Act (FMIA) Poultry and Poultry Products Inspection Act (PPIA) Virus-Serum-Toxin Act (VSTA)

U.S. Environmental Protection Agency (EPA):

For GM plants:

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Toxic Substances Control Act (TSCA)

U.S. Food and Drug Administration (FDA):

For GM plants and GM animals:

Federal Food, Drug and Cosmetic Act (FFDCA)

The US regulatory framework for GM plants and GM animals is best illuminated through the

study of the different regulatory bodies involved. As an example, the marketing/commercial

phase jurisdiction over the varied biotechnology products for GM animals would be determined

by their use, as has been the case for traditional products:

• Food from GM animals: FDA

• Food products prepared from domestic livestock and poultry: Food Safety and Inspection

Service (FSIS)-USDA

• Laboratory animals: Animal and Plant Health Inspection Service (APHIS)-USDA

• Animals for agricultural use: APHIS-USDA, e.g. GM animals producing a veterinary

pharmaceutical and GE animals conferring disease resistance; GM insects to control plant

pest or for animal health protection

• Animals for producing a human pharmaceutical: FDA

• Animals for non-agricultural use: EPA

In addition, other agencies (federal or state) are involved with permits for facilities, waste

water, production locations, slaughtering etc. as would be the case for non-GM animals.


There are 3 main bodies that regulate the safety for humans and the environment of the GM

products (EPA, APHIS and FDA) and one at the R&D stage (NIH). These bodies will regulate GMOs

using several existing health and safety federal laws developed to address specific product

classes. In order to avoid possible conflict or lack of harmonisation in the decisions taken by all the

regulatory bodies involved, the Co-ordinated Framework (CF) for Regulation of Biotechnology was

created in 1986 to ensure a “co-ordinated, risk-based system to ensure new biotechnology

products are safe for the environment and human and animal health”. This strategy has been

considered to avoid the dilution of relevant expertise whilst ensuring effective use of the existing

resources (A McHughen and S Smyth, 2007). The CF, formed by APHIS, FDA and EPA, has only

focused on green biotechnology. All the recombinant pharmaceutical products will be regulated

by FDA under the FFDCA, although APHIS will still regulate some aspects of GM animals such as

experimental trial in the environment.

Unfortunately, it was not possible to interview representatives from APHIS and FDA but EPA

agreed to be interviewed. Thus, the knowledge gained on FDA and APHIS is mainly through the

analysis of information available on their websites and from a review of academic/legal articles.

35

4.2.1. NATIONAL INSTITUTES OF HEALTH (NIH)

The NIH is the main Federal Agency for conducting and supporting medical research. They

have a key role in setting up guidelines for the research community and therefore have a role in

regulation of recombinant DNA technology at the R&D stage.

The NIH has published guidelines for the contained use of recombinant DNA (rDNA)

organisms in the ‘NIH’s Guidelines for Research Involving Recombinant DNA Molecules’ (51 FR

16958 May 7, 1986, originally 41 FR 27902 July 7, 1976). These guidelines are only legally

applicable to NIH-sponsored research but are widely used for private and federal research.

Under these guidelines, Institutional Biosafety Committees are the cornerstones of

institutional oversight of recombinant DNA research. They provide local review and oversight of

nearly all forms of research utilising recombinant DNA. The industry committees however, might

have different transparency standards, limiting the amount of information made available to the

public (e.g. meeting minutes, public representation in the committees) (SH Abramson et al.,

2001).

4.2.2. ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

Within the U.S. Department of Agriculture (USDA), APHIS (created in 1972) was originally

involved in issues relating to animal and plant health and their import/exports but have recently

also become responsible for “issues as wildlife damage and disease management; regulation of

genetically engineered crops and animal welfare; and protection of public health and safety as

well as natural resources that are vulnerable to invasive pests and pathogens”.

In regards to GM plants, APHIS will only regulate “organisms and products which are known or

suspected to be plants pests or to pose a plant pest risk”, called regulated articles and defined as

“any organism which has been altered or produced through genetic engineering, if the donor

organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated

in §340.2 of the Regulation”. The agency also analyses petitions to obtain a non-regulated status

for plants for which sufficient knowledge is gathered. The Agency, however, only focuses on the

probabilities of a regulated article becoming a pest species and does not take other issues into

account (e.g. the effects on biodiversity). In addition, APHIS will decide under NEPA if there is a

requirement for an environmental assessment (EA) or a broader environmental impact

assessment (EIS). All agencies that file an EIS will have to inform EPA, which is in charge of

reviewing it.

Despite the fact that APHIS has extensive experience in the assessment of GM plants and is

responsible for animal health and welfare, FDA has taken the lead as the regulatory body for GM

animals. However, whilst FDA will perform the risk assessment (see section 4.2.4 in more detail)

APHIS may still consider the potential effects of GM animals on the health of the livestock under

Animal Health Protection Act (AHPA) and Animal Welfare issues under the Animal Welfare Act

(although livestock remains excluded). In addition, the Food Safety and Inspection Service (FSIS)

within USDA will inspect animals before and after slaughtering and animal products, labelling etc.

for human use for safety, including the ones derived from biotechnology. Indeed, in 1991 FSIS

36

released ‘Livestock and Poultry Connected with Biotechnology Research’. Also, the Centre for

Veterinary Biologics within APHIS is responsible for reviewing the licence applications for

production facilities and biological products, import, testing, reviewing production methods etc.

With regard to pharmaceutical applications, APHIS will still be regulating transgenic animals

that are producing veterinary pharmaceuticals and transgenic animals conferring disease

resistance under the Virus-Serum-Toxin Act (VSTA). However, APHIS would only be regulating the

‘biological product’ rather than the whole animal. This is seen as a gap in the legislation however,

such an animal might be covered by AHPA.

Finally, APHIS is in charge of the import/export and release into the environment of GM

plants and probably, of GM animals. Applicants are required to supply information on the

genotypic and phenotypic characteristics of the plant and results from field test reports. As a

consequence, the Agency has been increasingly exposed to issues surrounding the trade of

agricultural products and has been very active in removing technical barriers through the

promotion of international standards, studies to support “safe, science-based trade” and building

consensus among US trading partners, industry and scientific community on “feasible, science-

based solutions to technical trade barriers”14.

4.2.3. ENVIRONMENTAL PROTECTION AGENCY (EPA)

In the mid-80s EPA, which was not originally involved in the regulation of GMOs, proposed

that it should regulate crops which had a pesticide activity under FIFRA and TSCA. This proposal

was accepted by the White House and EPA became part of the CF when it was created in 1986.

Under the US regulatory framework to GMOS EPA is the authority in the regulation of the

protein/gene that confers pesticide activity to GM plants (not the whole plant, which is APHIS’

responsibility). This decision received strong criticisms from the industry, which considered that

GM crops were becoming overregulated. Scientific bodies were also critical of this approach and

for example, the Council for Agricultural Science and Technology (CAST) stated that grouping all

traits that conferred pest resistance in one category was “scientifically illogical” (EW Nester et al.,

1998).

Moreover, further arguments occurred in the industry and scientific communities after the

EPA coined the term “Plant Pesticide”. Tensions reached a peak with the publication of the ‘11

Societies Paper’ (i.e. representing the opinion of 11 scientific societies) warning that “plant

pesticide” was not the appropriate definition because it could be interpreted by the public as if

they were eating pesticides. A compromise was finally reached between the Agency and the

industry to classify these transgenic plants as Plant-Incorporated-Protectant (PIP).

Based on EPA’s approach, plants with pesticide properties fall under the biopesticides

category defined as “pesticides derived from such natural materials as animals, plants, bacteria,

and certain minerals”. The Agency has still a very narrow remit on GMOs, and will for example,

not regulate herbicide-tolerant soya (although it will regulate its specific pesticide). PIPs in

14 http://www.aphis.usda.gov/import_export/plants/plant_exports/phytosanitary_management.shtml

37

addition, are only regulated by EPA if they are GMOs and if they are produced by traditional

breeding they are exempt of FIFRA and FFDCA requirements.

Before each PIP is approved, EPA performs extensive risk assessments of the effects that the

GM crop could have on human health such as acute reactions (allergy, skin reactions, etc.), long-

term effects (e.g. cancer) and effects due to different sources of exposure (e.g. water, food, etc) in

order to decide whether they pose unreasonable risks. In addition, EPA will perform

environmental assessments of the effects to non-target organisms and the environment, potential

gene flow and the need for insect resistance management plans. The ability to take into account

both, human and environmental safety matters places EPA in a very unique position within the CF

and it has been defined by academic literature as a more process-approached agency. Indeed, Epa

policymaker recognised that USDA or the State government would fund EPA’s policymakers to

attend international meetings as they are able to provide expertise in both fields. However, he

disagreed on the process-oriented claims and stated that their assessments are on a case-by-case

basis “if we were totally process-driven and we had the same Cry protein from Bt, we would just

say ‘OK, you don’t need to go through all this’ but we look at each one individually”.

To date, the EPA has registered 11 PIPs, some of them under conditional approval, where the

standard 15-year pesticide licence is granted with the requirement that the GM fields are

monitored for 5 years. Following this period, the data needs to be presented to the agency for

licence renewal. This has also been one of the EPA’s methods to keep up-to-date with issues

surrounding GMOs. Unsurprisingly, like their colleagues in EFSA, they have problems in defining

the goal of ecological monitoring and in defining the environmental baseline. Epa policymaker

believed that “if we felt we were really that concerned about monitoring a specific product, we

would probably never approve it, because it would just raise too many questions and keep too

many people up at night”. For similar reason, Epa policymaker was sceptical about the ability to

protect biodiversity as in the Cartagena Protocol (see section 10.4.1) because “the environment’s

going to react, certainly. It’s not a simple question. And I just hope that the people who are really

pushing that have thought about it”. Like his colleagues in EFSA, Epa policymaker felt that one of

the strongest limitations to EPA’s work was the uncertainty of science “there’s always a degree of

uncertainty. It’s just the question is: Can you deal with it? And if it’s too high an uncertainty, then

again [you] may have to just say no in some cases, or send people off to the field that takes that

kind of data”.

Gene flow is an important concern for EPA, even though currently there are no GM crops that

have wild counterparts in the US (except wild cotton in Puerto Rico and Hawaii), EPA is conscious

that this may become an issue in the future. Another issue that EPA had to tackle was the

increased presence of Bt resistant corn in the US fields. After external consultation EPA developed

the co-existence measures, with the requirement of growing so-called ‘refuges’ (blocks of non-Bt

crops) in the periphery of Bt crops for at least 20% of the acreage. Biotech industry has taken a

very active role in this matter and for example, founded the Agricultural Biotechnology

Stewardship Technical Committee (ABSTC) which took a role in informing corn growers about the

insect resistant management requirements through the Compliance Assurance Program (CAP)

with very positive results.

38

Overall though, the interviewee thought that the US system offered good environmental

protection although he believed it was hard to translate to other countries because of the

different types of environment. He clarified that “I don’t think we are on the same page though,

with some other countries…we don’t see in terms of environmental impacts, we see benefits in

terms of insecticide reductions”. Furthermore, because FIFRA is a cost/benefit statute,

policymakers will consider the added environmental value when comparing the effects of PIPs

versus pesticides. The interviewee felt that there had been some significant changes to harmonise

their guidelines with the requirements of other countries. In addition, in order to keep up to date

with recent scientific advances, the Agency is currently working on new PIPs guidelines which are

expected for released in October 2010. Nevertheless, Epa policymaker confirmed that the

industry is still very reticent to EPA’s role in regulating PIPs. The interviewee believed that certain

sectors of the US industry are not considering the effects that not taking into account

international standards can have on US exports.

Within the USA, it is mainly the biotech industry that approaches EPA but other stakeholders

that will regularly contact them include consumer and ENGOs lobbies which follow their

approvals. There is also a vocal minority that is anti-GM in the US, although as the interviewee

noted their concerns were generally more related to capitalism or a specific corporation (i.e.

Monsanto) rather than the science of GMOs. On the other hand, Epa policymaker felt that

scientists were not very involved with their work and tended to contact the Agency only when

their project is at an advanced stage to express their concerns. Internationally, the EPA has set up

numerous collaborations with other countries, of which Canada is their strongest collaborator.

There is currently not much collaboration with India and with the EU, apart from the “exchange of

notes” at international meetings.

EPA will have no role in GM animal regulation as this is not included in their statutory

authority. When asked about the expertise of FDA to perform the environmental risk assessment

for GM animals, Epa policymaker said that it was too early to say.

4.2.4. FOOD AND DRUG ADMINISTRATION (FDA)

FDA’s mission is to protect the public health by ensuring that foods are safe, wholesome,

sanitary and properly labelled under the Federal Food, Drug and Cosmetic Act (FFDCA). This Act

covers all imported and domestic food except for meat and poultry that are regulated by FSIS of

USDA.

FDA does not require the approval of a product before it is placed on the market and, instead,

the consumer is protected by prohibiting adulteration and misbranding. Food additives are

considered unsafe unless the FDA has stipulated the conditions under which they are safe (either

on its own initiative or in response to petition).

Food can also have the status of a Substance Generally Recognized as Safe (GRAS). Products in

use before 1958 are considered safe on the basis of ‘common use in food’, after 1958 a ‘scientific

procedure’ must determine its safety. The GRAS self-declaration by a company wishing to put its

product on the market does not need being reviewed by FDA, although it certainly will merit from

FDA’s review. Most manufacturers conduct their own review, notify FDA and then keep the data

39

available for FDA. Besides FDA, applicants can also turn to other institutions for reviews of GRAS

listings, such as the Flavor and Extract Manufacturing Association (FEMA) for flavourings. This

latter procedure hinges on the wide recognition within food industry of the outcomes of FEMA’s

review procedure. Food derived from GMOs is treated the same way as food developed through

traditional breeding, meaning that a pre-market approval is only required in case of a food

additive.

This relaxed approach to GM food has put the FDA in the spotlight where even scientific

associations such as CAST have considered the voluntary pre-market review as “a potential

weakness” (SH Abramson et al., 2001). In response to the increasing concerns, FDA proposed in

2001 a mandatory pre-market notification for all products produced by agricultural

biotechnology. However, this rule never came into practice due to strong pressures from the pro-

GMO lobby (DC Dragos and B Neamtu, 2008). Indeed, FDA has been described in academic

literature as sharing a similar view on the regulatory approach to biotechnology with the US

industry, with a so-called ‘revolving door’ of staff moving from industry to FDA and vice versa (T

Bernauer and E Meins, 2003, G Skogstad, 2003).

A very different scenario has been developed to regulate GM animals, led by the Center for

Veterinary Medicine (CVM) within FDA. The Agency concluded that a recombinant DNA construct

intended to affect the structure or function of an animal met the definition of a “new animal

drug”, regardless of the intended use of the products produced by the GM animal. Under the

FFDCA, a new animal drug is “deemed unsafe” unless FDA approves a New Animal Drug

Application (NADA) for that particular use. The use for research falls under the Investigational

New Animal Drug (INAD) exemption (an “INAD file” is filed with CVM).

FDA is still in discussion with other agencies regarding how to define and clarify the approach

for oversight on the different types of GM animals. Currently, FDA does not regulate GM animals

developed for plant pest control (e.g. GM insects) or non-food species raised and used in

contained and controlled conditions (e.g. laboratory animals). However, FDA did review the

information on Zebrafish aquarium fish (Danio reiro) genetically engineered to fluoresce in the

dark (GloFish) based on the evaluation of risk factors (or safety concerns). The Agency will also

assess the environmental effects that directly or indirectly affect the health of humans or animals,

should it permit the use of the new animal drug.

With this new approach, FDA considers the rDNA construct as an animal new drug. The

insertion of the rDNA may affect both the health of the animal and the level and control of the

expression of the construct (i.e. its effectiveness). This means that each event is regarded as a

separate new drug. This is a significant regulatory U-turn as it means that for the first time in US

GMO governance a transgenic organism will be regulated as a whole rather than focusing on the

inserted gene/protein. Furthermore, unlike GM plants, under FFDCA GM animal approval

becomes a mandatory process.

In a NADA the applicant has to demonstrate that the new animal drug is safe and effective for

its intended use. The information needed in order to establish food safety for food from GM

animals under a NADA is consistent with the one described in the Codex Alimentarius Guideline

on Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. An environmental

40

assessment is required at least until FDA has more experience on the subject. A summary of the

NADA (Freedom of Information summary) and the EA are posted and available to the public.

CVM has developed under the FFDCA, a 7-step cumulative approach to asses transgenic

animals where applications will have to be approved for each step in order to move to the next

one. The first 3 steps concentrate on the rDNA construct and its integration in the animal, the

following 3 steps focus on the risks associated to this GM animal and the final step assesses the

effectiveness and validates the claim of the first step. Therefore, the review is subdivided into the

following steps:

Step 1: Product identification/definition, a broad statement of the GM animal and its characteristics.

Step 2: Molecular characterisation of the construct, description of rDNA construct and how it is assembled.

Step 3: Molecular characterisation of the GM animal lineage, description of the method that the rDNA introduced into the animal and how stable it remains.

Step 4: Phenotypic characterisation of the GM animal, description of the health and characteristics of the GM animal.

Step 5: Genotypic and phenotypic durability assessment, stability over time of the phenotype and genotype of the GM animal.

Step 6: The food/feed safety and environmental safety assessment, analyses of the impacts that the GM animal poses to the environment and the safety of the food/feed derived from the animal.

Step 7: Effectiveness/claim validation, checks that the GM animal fulfilled the claim made in step 1.

The INAD regulations specify labelling and record-keeping requirements, animal disposition,

and conditions under which food from animals that are used for clinical investigations can be

introduced into the food supply. For the latter an Investigational Food Use Authorization is

needed. The FSIS (USDA) is to inspect slaughtering of these animals regarding the maximum

allowable amounts of the new animal drug residues set by FDA. INADs may require an EA or EIS

under NEPA. Once a GM animal is approved, applicants have on-going responsibilities which

include registration and drug listing, recordkeeping, filing supplements, and periodic reporting.

With regard to the post-approval monitoring of GM animals, FDA has yet to position itself to

whether it will be used or not for GM animals. There is a supply chain management system for

clones to ensure that if suppliers wish to segregate clones from non-clones they will be able to do

so. For the moment though, GM animals are only required to have a descriptive label

accompanying them throughout the chain (although not for their derived products).

The FDA also has statutory authority over food labelling and in line with US industry, it has

remained a strong advocate of the voluntary labelling of GM products unless the recombinant

product has different properties. Indeed, the ‘Guidance for Industry on Voluntary Labelling’

explains that “the term ‘GMO free’ may be misleading on most foods, because most foods do not

contain organism…it would likely be misleading to suggest that a food that ordinarily would not

contain entire organism is ‘organism free’” and “consumers assume that ‘free’ of bioengineered

material means that ‘zero’ bioengineered material is present…accuracy of the term ‘free’ can only

41

be ensured when there is a definition or threshold”. Instead, FDA suggested using a more accurate

“We do not use ingredients that were produced using biotechnology” label.

With regard to pharmaceutical applications using recombinant technology, the final product

(from plant, animal or micro-organism origin) will be regulated by the responsible centre within

FDA although the GM animal itself will still have to go through the 7-step approval process at the

CVM.

5. THE REGULATORY FRAMEWORK IN CONTEXT:

The US is the major producer of GM crops with 64 million of hectares cultivated in 2009

mainly with maize, corn and cotton15. It is internationally perceived as having a very permissive

approach towards GMOs and this was confirmed by the majority of interviewees. Moreover, the

US is unique in its use of existing legislation to regulate GMOs with 3 agencies regulating different

aspects of GMO that fall within their statutes. This approach however, has caused some

regulatory gaps as recognised by Epa policymaker: “in some cases you think well we should be

looking at that, well you don’t have authority to do it” and in fact, Efsa scientist 1 explained that

“USDA has a very tight mandate and is not really meant to go outside that mandate, but are being

criticised for not going outside the mandate and for sticking closely to their particular area, so it’s

more a criticism of the system…*environmental assessment+ it’s compartmentalised as I said USDA

tend to look at agriculture, EPA tend to look at particular aspects but not the broader parts, and

that is where there are problems”.

The USA has always advocated a more balanced approach towards GMOs by taking into

account the benefits as well as risks. This approach is fairly unique within the GMO debate, where

mentioning benefits is directly associated with promoting GMOs (not even neutral multi-national

bodies such as the WHO highlight the benefits of GM technology). In fact, this approach has been

widely criticised by ENGOs, particularly in Europe. It should be mentioned though, that in the

wording used by FDA’s communications when discussing GM plants the Agency systematically

avoids mentioning the risks associated with GM technology. This approach has been interpreted

as taking a pro-GM position. Furthermore, even though in theory the US GMO governance system

does not take into account socio-economic factors (that is in addition to consumer

safety/environmental protection) the CF agencies are sensible to the economic losses that certain

regulatory measures can cause to the industry. This however, is also due to the need to find a

balance with the industry as explained by Epa policymaker “if it becomes a long-term study, then

you’re essentially going to negate the economics of a company or an individual developing, as it

just becomes too expensive and onerous and so they’re going to look for an alternative means to

do something that’s not regulated and well, say it’s somewhat of a balancing act”.

Whether it is a food/feed or a pharmaceutical application, the risk assessment process is

subdivided among the different agencies depending on nature of the product. USDA-APHIS is the

main regulatory authority on GM plants and will be involved in the analysis of the transgene, its

15 http://www.isaaa.org/resources/publications/briefs/41/executivesummary/default.asp

42

molecular characterisation and the environmental risk assessments. EPA will only be involved in

the process if the product requires an EAS or if the recombinant plant falls under the PIP category.

FDA has a minor role unless in the case where the product is considered an additive. Otherwise,

the industry is only required to voluntarily consult with the agency before releasing it into the

market. FDA nevertheless, is still involved in the regulation of plant biopharming products (also

known as Plant-Made Pharmaceuticals) and oversees the labelling of GM products. The

communication among all the CF regulatory bodies was described by Epa policymaker to be very

good, with monthly conference meetings (in which other state departments might join) and

regular informal contact.

The risk management is also fully operational although there is some variation on the

permissiveness accorded to GM crops among different States where for example California, Texas

and Florida are more sceptical of GMOs. Hawaii is also more restrictive and does extensive

ecological monitoring, although Epa policymaker noted that it was not due to a stronger ENGOs

presence but, rather, to the initiative of the local APHIS and EPA branches. Furthermore, the

States’ position on GMOs has also changed over time. For example, North Dakota, with an

important organic industry, wanted to pass a law banning GM wheat 5 years ago and now they

have plans to introduce it.

The CF agencies have been involved in several GMO conflicts. It is not clear if these were due

to regulatory gaps or to the fact that the US is the major GM crop producer with a consequent

increase in the probability of errors occurring. The most controversial ones include:

StarLink, in 2000 traces of a GM seed only approved for feed were found in taco shells. The

industry was required to perform extensive monitoring and according to Epa policymaker, it

was the first time that people started to ask about the food production chain. Since that

incident, PIPs have been approved simultaneously for food and feed.

Research linking the decrease of Monarch butterflies to the 176 Bt corn variety (JE Losey et

al., 1999). In response to these concerns, EPA issued an extensive Data Call-In to farmers to

gather information and performed further research which concluded that “consideration of

hazard and exposure factors indicates that Bt corn pollen represents a low to negligible risk

to monarchs and other non-target lepidopterans”16.

Soy beans in Nebraska were found to contain small number of ProdiGene corn producing

pharmaceutical material in 2000. USDA and the Nebraska government ensured that the

contaminated soy was destroyed and did not reach the food supply.

Syngenta Bt10 unapproved corn was detected in the seed supply in 2004. Before the

company and the US made the official announcement, several countries were affected by

the Bt10 imports, including the EU.

The increased number of court cases challenging the CF agencies (especially USDA) (A

McHughen and S Smyth, 2007, KL Kollman, 2003, P Stewart and AJ Knight, 2005) combined with

16 http://www.epa.gov/oppbppd1/biopesticides/pips/executive_summary_and_preface.pdf

43

the losses in their US agricultural sector as a consequence of international trade disruptions,

translated into stricter regulations for GMOs (e.g. in 2001 FDA proposed mandatory labelling and

in 2003 APHIS strengthened the conditions for permits). More importantly, there has been an

overall effort to harmonise international guidelines through the participation in the OECD and

Codex meetings. It was also envisaged by Epa policymaker that in the near future, the US would

have to handle agricultural imports from countries such as Brazil which are expected to pose new

regulatory challenges.

Risk communication has been present throughout the history of GMO governance in the USA.

Websites from all 3 agencies provide context to the GMOs as well as highlighting their

advantages:

Example 1: Providing Context

“Clearly most agricultural crops and animals raised for food production have been genetically modified over the years…for thousand years through natural selection, and for more than a hundred years through the focused efforts of scientists and farmers” – FDA website

Example 2: Highlighting the benefits – explanation by FDA (USA) and DG SANCO (EU) of the use of biotechnology to modify the genetic makeup of organisms.

“Today’s techniques are different from their predecessors in two significant ways. First they can be used with greater precision and allow for more complete characterization and, therefore, greater predictability about the qualities of the new variety. These techniques give scientists the ability to isolate genes and to introduce new traits into food without simultaneously introducing many other undesirable traits, as may occur with traditional breeding. This is an important improvement over traditional breeding” – FDA Website

“In recent times, it has become possible to modify the genetic material of living cells and organisms using techniques of modern biotechnology called gene technology. The genetic characteristics are being modified artificially in order to give them a new property” – DG SANCO Website

Epa policymaker explained that there is a strong emphasis from the US Agencies to

communicate under a single voice. Indeed, the Agricultural Biotechnology Support Fund

supported the development of the ‘US Regulatory Agencies Unified Biotechnology Website’17 with

a clear aim to enhance the image of unity among Agencies to the American consumer. In addition,

the use of ‘genetically engineered’ rather than ‘modified’, the guidelines for labelling and the

rejection of the use of ‘plant pesticide’ are clear examples of the investment in risk

communication. Consumer surveys are also taken into account and for example, the FDA

guidelines on labelling GMOs noted that “data indicates that consumers do not have a good

understanding that essentially all food crops have been genetically modified and that

bioengineering technology is only one of a number of technologies used to genetically modify

crops”18.

At the international level, the USA has several collaborations with other countries and for

example, APHIS (through USAID) has provided expert advice to many countries, including India.

Their major partner is Canada, which has a similar attitude towards GMOs but has a specific and

more restrictive legislation. Another example of collaborative work is the current negotiations to

17 http://usbiotechreg.nbii.gov/index.asp

18http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingn

utrition/ucm059098.htm

44

have joint TRIPS registrations and sharing of personnel in agriculture among USA, Canada and

Mexico.

In order to explain the current regulatory landscape for GM plants, it is important to take into

account the role of industry as a stakeholder in the US GMO governance. The agricultural industry

in the US is highly industrialised, localised and increasingly dependent on biotechnology (KL

Kollman, 2003). In addition, the biotech lobby has been actively engaged with farmers

associations although as Rtd policymaker recognised, not without controversy as “they check in

the fields whether there are GMOs in the fields or not and there have been many Court cases,

particularly in the US”. The presence of a very well-orchestrated and cohesive pro-GM lobby has

also ensured that anti-GM groups have been isolated from the agenda-setting process (T Bernauer

and E Meins, 2003, J Chataway et al., 2004). For example, anti-GM animal campaigns failed in

Massachusetts due to the success of the industry lobbies in proclaiming themselves as protectors

of the State’s economy and stressing their close relationship to the government (J Urbanik, 2007).

The government has also taken a pro-industry approach when, with the first arrivals of GMOs into

the market, the White House decided to promote this biotechnology by minimising the regulatory

burden and USDA, with a reputation for being a business-friendly body, was chosen as the leading

agency (KL Kollman, 2003).

Nevertheless, the American public has never shown any major concern over GM crops and

their products although there is still a minority opposed to biotechnology. However, Epa

policymaker noted that most of the concerns were related to food and not that much on the

environment, and thought that the European GMO debate had not particularly influenced the US

anti-GM movement. Epa policymaker also perceived that most of the anti-GM opposition was

against capitalism in general, and Monsanto in particular, rather than GM technology and

confirmed the general belief that in the US “the public has a sense that their governmental

agencies are doing a reasonable job”. Therefore, the overall public acceptance of GMOs coupled

with the effective lobbying by industry groups might explain why with the exception of certain

states such as California or Alaska, the American anti-GM campaigns were not as successful as the

European ones (T Bernauer and E Meins, 2003, J Urbanik, 2007). Greenpeace for example, was

only successful when they targeted baby food (T Bernauer and E Meins, 2003). Furthermore, most

campaigns do not aim to ban GMOs but rather, to promote rigorous screening and safety

protocols (KL Kollman, 2003).

Other stakeholders such as scientists did not seem to have much contact with the EPA (could

not confirm for other agencies). However, several scientific associations like the National

Academy of Science (NAS) or Council for Agricultural Science and Technology (CAST) have written

numerous technical reports on GMOs. Finally, consumer associations also contact EPA although

again, we were not able to confirm if they approach FDA or APHIS.

In conclusion, there are some key factors that explain the regulatory landscape of GMOs in

the US. The success of the pro-GM lobbies, the different attitude of the US consumer and the

investment of the different agencies in providing context regarding GMOs are some of the key

factors that help explain the high levels of acceptance of this technology in the US, certainly when

compared to other parts of the world, particularly the EU.

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6. GM ANIMALS IN THE USA

The US is the first country to publish guidelines for the regulatory approval of GM animals.

Their approach to GM animals departs significantly from the regulation of GM plants, with a RA in

line with the Codex guidelines on food derived from biotechnology. CVM-FDA has become the

lead agency responsible for the risk assessment of GM animals, leaving APHIS with a yet to be

defined secondary role19. EPA on the other hand, has been excluded from GM animal oversight

(their statutory authority is only on pesticides), leaving the responsibilities of performing the

environmental risk assessment to the FDA. Interestingly this Agency has no expertise on the

assessment of the environmental risks for GM plants (unlike APHIS or EPA). This has raised the

concerns of several stakeholders including ENGOs and the National Research Council20 although

Epa policymaker stated that “it is still too early to say”. In fact, the Center’s environmental

expertise is not the only expertise questioned. H. Miller even questioned CVM’s expertise in

molecular biology stating “it [CVM] has a lower profile than other FDA centers, it has difficulty

attracting and recruiting personnel familiar with the nuances of modern molecular biology” (H

Miller, 2008).

The rationale behind the regulation of GM animals under such a different framework has

been defended by FDA: “US law generally treats plants and animals differently…the GE

procedures for GE plants will, of necessity, differ from the regulatory procedures of GE

animals…another reason is that, unlike plants, animals can transmit diseases to humans…(e.g.

swine flu). Depending on the nature of the modification to an animal…genetic engineering can

enhance (or minimize) risks to human health…GE animals can pose human health risks that would

not arise with GE plants”. This is one of the few occasions where FDA will recognise that

transgenic organisms can pose risks to humans. Indeed, it goes even further than this and claims

that “GE animals have intentionally been changed. That change may affect the health of the

animal, as well as the safety of food from the animal21”. This contrasts with the wording used

regarding GM plants “the small amounts of genetic material introduced through biotechnology,

and the resulting proteins, are unlikely to dramatically change that safety profile22”. Why do these

‘changes’ are only significant in the phenotype of animals?

There might be several reasons to explain such a structural shift in the USA with regard to the

regulation of GM animals. First of all, the American public is more sensitive to transgenic animals

than plants. It has taken the FDA more than 20 years to develop the final draft of the guidelines

and the public consultation received the highest number of responses in FDA’s history (28,000

comments). In fact, certain criticisms such as the transparency of the process if regulated under

FFDCA were so common that the Agency included them in the final guidelines. Epa policymaker

believed that the public would be more apprehensive of the idea of having “engineered pigs

running loose”. Furthermore, a report by CAST on the ethical implications of animal biotechnology

19 USDA notified in their website “APHIS will continue to work closely with FDA to determine its role in the

comprehensive oversight over GE animals”. 20

http://www.nature.com/nature/journal/v456/n7218/pdf/456002a.pdf 21

http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEng

ineeredAnimals/ucm113605.htm 22

http://www.fda.gov/NewsEvents/Speeches/ucm054311.htm

46

concluded that “when science, ethics, religion, and social science are viewed concurrently…it

becomes apparent that society is struggling to develop public policies that appropriately reflect

the diverse set of considerations that bear the applications of animal biotechnology in agriculture

and the food system” (PB Thompson et al., 2010).

The FDA is well aware of the importance of public acceptance and states “approval by FDA or

a food regulatory group in another country does not guarantee public acceptance”23. The Agency

has taken into account the different cultural beliefs and ethical values and for example, it stated

on their website that “*labelling+ will likely be even more important to consumers desiring

choice”7. The Agency considers however, that these issues are out of the scope of their regulatory

role although they should still be taken into account. In fact, the FDA is planning to participate in

debates to ensure that “discussions are based on fact and not on erroneous assumptions

regarding the technology or its outcomes”24. For example, the Agency organised a 2-day workshop

entitled ‘Biotech in Barnyard: Implications of Genetically Engineered Animals’ where experts

answered public queries on topics ranging from molecular biology to animal welfare.

FDA is still carefully shaping their communication to increase public confidence in their role as

regulators (e.g. “only food from GE animals that is safe to eat will be permitted into the food

supply”) although a pro-GM opinion is still apparent throughout its website. This is especially

evident in GM animal pharma applications: “GE animals that produce pharmaceuticals provide

natural production systems for therapeutic proteins previously available only through purification

from human cadavers or animal carcasses”24. Cell cultures are certainly a less emotional but yet

highly efficient alternative to obtain these proteins.

Another possible reason for this new policy approach might be economic. Despite the

resources dedicated by the pro-GM lobby to the promotion of the benefits of this technology

globally, the lack of mandatory labelling and the relaxed approach on GMO regulation has caused

numerous trade problems. Indeed, there have been trade-related tensions reported with

countries where citizens were more concerned over GMOs such as the EU states, its major trading

partner. Support for this hypothesis can be seen in the fact that these guidelines are in agreement

with Codex and the positive response by BIO (the American association of the biotechnology

industry) which commented “BIO considers it significant that FDA is aligning [the guidance] with

Codex, which will be widely used by other countries” (JL Fox, 2008). On the other hand, the FDA

recognises that cultural variability can affect the market: “development of a world market for a

transgenic animal variety is currently fraught with difficulties doing to the varying cultural views of

governments”23.

It should also be noted that some of the limitations on the arrival of this technology in the

market are due to the lack of venture capital. As stated by Epa policymaker “the bottom line

is…they don’t have a Monsanto or Dupont or Syngenta behind them”. Most of the GM animal

applications have been achieved through public research and spin-off companies. As expected,

these groups do not have the resources or capacity to go through the regulatory procedure or to

23 http://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm047112.htm

24http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEng

ineeredAnimals/ucm113605.htm

47

lobby the government as big multinational companies do. Epa policymaker commented that in a

meeting at the University of California one of the scientists working on transgenic animals said

“you’ve got 75% of all the GE animal scientists right here” in a room with 6 people. It is therefore

not surprising that they have strongly criticised the FDA’s decision and ask a for similar regulatory

process to that of GM plants. For example, H. Miller criticised FDA’s use of the FFDCA to regulate

GM animals stating “when the only tool that you have is a hammer, more and more problems

begin to look like nails” (H Miller, 2008).

On the other hand, in the USA (as in other countries) the pharmaceutical applications enjoy

higher public acceptability than food applications and this pattern is still maintained for GM

animals. It is therefore not surprising that the first application to pass the 7-step system was that

of a bioreactor (ATryn goat by GTC Biotechnology). In fact, the new approach was more

transparent than EMA’s approval process with the final documents easily accessible from the

website. Unfortunately, the cross-contamination case in the University of Illinois, where

transgenic pigs for research were not properly disposed of and entered the food supply proves

that containment measures need to be taken seriously if the animal biopharming industry is to be

established. Indeed, APHIS experience with regard to plant biopharming has highlighted the

difficulties of isolating these plants (see ProdiGene in the previous section as an example).

The next GM animal that FDA examined was GloFish, although it was exempt from any

regulatory approval because it was not part of the food chain and considered safe for the

environment25. After 10 years of conversations with the FDA AquaBounty salmon will probably be

the third GM animal to be approved. Both media and the scientific community have shown their

concerns over possible adventitious releases of transgenic salmon as there is already a significant

amount of scientific literature studying the environmental damage caused by fish farming

escapes. In fact, Epa policymaker said “I think that’s a though product” and thought that FDA

should have focused on something with a clearer benefit for the consumer. Similarly, FDA

acknowledged the controversy surrounding the GM salmon and stated in their website

“improvements offered by transgenic fish…must be dramatic when compared to what is possible

by other, better-accepted, approaches”. Despite the existing concerns, AquAdvantage salmon was

found to be safe for human consumption by FDA in August 2010. When looking for possible

reasons for AquaBounty to invest in the GM salmon, it is not surprising to find that the

aquaculture industry, unlike the other breeding industries, has a similar structure to the

agriculture industry. As stated by our WP3 colleagues, aquaculture industry is the fastest growing

industry, with few multinational companies monopolising the market. Moreover, within the

aquaculture industry, salmon is the fastest growing sector.

As in the case of GM plants, AquaBounty’s approval will likely influence changes in the

regulatory framework of other countries as it would be the first GM animal to enter into the food

chain. All the attention will soon be placed on Marine Harvest Group, the largest salmon producer

(in 2008 produced 20% of the total world production of salmon), to see if this Norwegian

company mirrors Monsanto’s approach - although the American public might be more resistant to

the idea of eating transgenic fish.

25 http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm106233.htm

48

CASE STUDY 3: INDIA

7. INTRODUCTION TO THE REGULATORY FRAMEWORK

The factors influencing GMO governance in India (as in many other developing countries) are

very different from those in the US or EU. With almost one third of the population living below

the poverty line (mostly concentrated in rural areas) 26 GM crops have been seen as a promising

solution to food safety. Following the success of Bt cotton which transformed the country from an

importer of cotton to a powerful exporter, the government has invested heavily in GM

technology. The results are starting to show with Bt brinjal ready for commercialisation, and 21

crops (with 27 traits) in the pipeline. With regards to pharmaceutical GMOs, India is emerging as a

powerful biotechnology economy and as G. Padmanaban stated, “has just crossed the lag phase

and is at the beginning of the log phase of growth in the sector” (G Padmanaban, 2003).

However, there are still some issues that Indian policymakers need to address at the

regulatory and implementation stage if the years of investment in this technology are to be

translated into benefits for the Indian population. The Bt cotton and Bt brinjal experiences will be

used as examples to illustrate the complexities of GMO governance in developing countries.


Biotechnology regulation has a comparatively long history in India (See Appendix 4 for a

complete list of the legislation regarding GMOs). The first biosafety rules and guidelines were

published in 1989 making it the first developing country to have regulations for biotechnology.

The ‘Rules for the Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms,

Genetically Engineered Organisms or Cells’ (The Rules, 1989) cover all areas of research,

development, import and large scale applications. The Rules, 1989 state that research is only

allowed if laboratories work under the Environment Protection Act (EPA) and that any activity is

prohibited except when approved by the competent authority. However, The Rules do not

mention the performance of a risk assessment.

Responding to the advance in biotechnology, the government has developed several sets of

guidelines such as the ‘Recombinant DNA safety guidelines, 1990’, the ‘Recombinant DNA safety

guidelines and regulations, 1990’ and the ‘Revised guidelines for safety in biotechnology, 1994’.

These guidelines cover areas of research involving GMOs, including genetic transformation of

green plants, rDNA technology in vaccine development and the large scale production and

deliberate/ accidental release of organisms, plants, animals and products derived by rDNA

technology into the environment. Human cells and embryos are excluded from the scope of all

the aforementioned guidelines. They employ the concept of physical and biological containment

and the principle of good laboratory practices (GLP), provide the criteria for good large scale

practices (GLSP) and are based on the WHO laboratory safety manual. Basic scientific

26 http://www.fao.org/countryprofiles/index.asp?lang=en&iso3=IND&subj=1

49

considerations are outlined that may be relevant in assessing the possible risks associated with

the use of rDNA organisms.

These guidelines also prescribe the criteria for assessment of the ecological aspects on a case-

by-case basis for planned introductions of rDNA organisms into the environment and the various

quality control methods needed to establish the safety, purity and efficacy of rDNA products.

The Recombinant Guidelines, 1990 also stipulate three categories of research activities:

Category I for experiments involving self-cloning and inter-species cloning, Category II for

activities that require prior intimation of a competent authority falling under certain containment

levels, and Category III for activities that require approval such as including toxin gene cloning or

cloning of genes for vaccine production. Genetic engineering with plants or animals is classified as

a Category III, requiring review and approval of the competent authority.

The Seed Policy, 2002 aims to protect biodiversity by stating that all transgenic crops need to

be tested for environmental safety and biosafety before being released commercially. In addition,

India ratified the Cartagena Protocol in 2003 in order to place some regulatory control on their

GM imports. Nevertheless, the Gazette Notification No. GSR 616(E) (4/10/2006) exempts certain

categories of recombinant pharma from the purview of Rules,1989. Likewise, Gazette Notification

No. S.O. 1519(E) (23/08/2007) exempts from these rules GM food stuffs, ingredients in foodstuffs

and additives, food and food products that are no longer Living Modified Organisms (LMOs).

However, this is kept in abeyance by later Gazette Notifications.

For food applications, there is the Food Safety Standards Act, 2006 which consolidates the

laws relating to food, repeals the Prevention of Food Adulteration Act & Rules, and establishes the

Food Safety and Standards Authority of India. The Authority’s role is to establish science-based

standards for food articles and to regulate their manufacture, storage, distribution, sale and

import to ensure the availability of safe and wholesome food for human consumption. In addition,

the Indian Council of Medical Research (ICMR), in its capacity as the scientific and technical

advisory body to Ministry of Heath, Family and Welfare (MoHFW), has formulated guidelines to

establish the safety assessment procedures for foods derived from GM plants based on the Codex

guidelines. Because processed food products are not replicated in the environment, they are not

considered to be an environmental safety concern under the 1989 EPA. Processed biotech foods

may have health and human safety concerns, and therefore should be reviewed under the Food

Safety provisions.

In pharmaceutical applications, the Drugs and Cosmetic Rule (8th Amendment), 1988, issued

by the Ministry of Health and Family Welfare (Department of Health) specifically addresses ‘new

drugs’. Product safety, efficacy, clinical trials and market authorization of recombinant drugs are

regulated by the Drug Controller General of India (DCGI) under the authority of the Drugs and

Cosmetics Rules 1945 (Rules, 1945) of the Drugs and Cosmetic Act, 1940. The objective of the Act

is to regulate the import, manufacture, distribution and sale of drugs. Reference is made to the

general regulations that are applicable to biological drugs. A licence is always necessary, even if

the product is considered to be chemically and physically similar to a naturally occurring

substance or previously approved product produced in conventional system.

50

With regard to GM animals there are no specific guidelines but there are general

requirements for animal housing and safety precautions for research animals. From the ethical

point of view, the guidelines state: “The use of laboratory animals for experimental and diagnostic

purposes imposes on the user the obligation to take every care to avoid causing the animals

unnecessary pain or suffering. They must be provided with comfortable, hygienic housing and

adequate, wholesome food and water. At the end of the experiment they should be destroyed in a

humane, painless manner.”

India has in addition, a number of pieces of legislation relating to animal handling such as the

‘Prevention of Cruelty to Animals Act, 1960’ which deals with any animal including those used in

experiments. It establishes the Animal Welfare Board of India to promote animal welfare. There

are several sets of rules under the act that control cruelty to animals, breeding and supervision of

experimental activity among other things.


India’s GMO governance has a similar structure to the European regulatory framework, with a

set of specific laws (in line with the Codex) to regulate GMOs. However, the government has a

completely different approach to GM applications from the American and European governments.

The Indian government maintains a very close control of the different applications that are in the

pipeline, whereas in the EU and USA only the regulatory agencies will be involved with the

applicant/sponsor.

In other words, the government of India keeps tight control from the R&D stage of all the

applications, rather than evaluating the products once they are ready to be marketed. This

approach is not surprising as most of the research on GMOs has been funded through

government initiatives, notably from the Department of Biotechnology (DBT). Bt brinjal is a good

example of this approach. A need was first identified (i.e. very common vegetable which is

significantly affected by pests) and subsequently, the government supervised the entire

development until the final approval by GEAC. In this respect, Indian policymakers follow a similar

approach to their American counterparts as the applicant will be able to maintain regular contact

with civil servants.

Currently, before a GMO is marketed, the application will go through 6 competent authorities

(see section 7.2.4 for more detail) although only 3 are involved in the actual approval of the

GMOs:

The Institutional Biosafety Committee (IBSC) which monitors the projects at R&D level.

The Review Committee of Genetic Manipulation (RGCM) which monitors research activities and small scale field trials.

The Genetic Engineering Appraisal Committee (GEAC) which authorises large-scale trials and the environmental release of GMOs.

51

However, this procedure is expected to change soon with the creation of a single regulatory

body (Biotech Regulatory Authority of India) that will assess all biotechnology applications, similar

to that seen in the US with FDA or in Europe with EFSA/EMA.

7.2.1. INSTITUTIONAL BIOSAFETY COMMITTEE (IBSC)

The IBSC is involved with the review and clearance of project proposals that fall under any of

the categories mentioned in the Rules, 1989. It also has to ensure that the personnel are properly

trained on biosafety and the adoption of emergency plans.

These committees are set up in all the research institutions and are composed of scientists

engaged in this type of work, a medical expert and a nominee of the Department of

Biotechnology (DBT). Through this method, the Review Committee on Genetic Manipulation

(RCGM), also under the DBT, will be updated with all the projects that are under each IBSC.

7.2.2. REVIEW COMMITTEE ON GENETIC MANIPULATION (RCGM) UNDER THE DEPARTMENT OF

BIOTECHNOLOGY (DBT) – MINISTRY OF SCIENCE AND TECHNOLOGY

The Ministry of Science and Technology created the National Biotechnology Board in 1981.

By 1986 the board had evolved into the current Department of Biotechnology (G Padmanaban,

2003). All Indian interviewees agreed that the DBT has played a key role in the investment in

biotechnology made by the government and in GMO research in particular. Because it foresees

the benefits that GMOs can bring to the Indian population, the DBT has invested heavily in GM

technology to the point where the research budget was not seen by Indscientist as a limiting

factor.

The RCGM is responsible for maintaining the safety of the ongoing research projects and

activities involving GMOs. It is formed by members of DBT, Indian Council of Medical Research

(ICMR), Indian Council of Agricultural Research (ICAR) and the Council of Scientific and Industrial

Research (CSIR). The Committee will also create guidelines specifying the procedure for the

regulatory process and for ensuring adequate precautions and containment conditions in the field

trials. For transparency purposes, the ongoing project and field trial data is published on a regular

basis on the Indian GMO Research Information System (IGMORIS) website.

7.2.3. GENETIC ENGINEERING APPROVAL COMMITTEE (GEAC) UNDER THE MINISTRY OF ENVIRONMENT

AND FORESTS (MOEF)

The GEAC falls under the ministry of Environment and Forests (MoEF) and is responsible for

the approval of activities involving large-scale use of GMOs and their release into the environment

including experimental field trials. Similar to RCGM, GEAC is composed of representatives from

the MoEF, DBT, ICAR, CSIR and ICMR among other experts.

MoEF is also in charge of applying the Cartagena Protocol (and the Convention of Biological

Diversity) as India is one of the few countries that exports GMOs and has ratified the Protocol.

This, however, was not seen as causing any conflict by the Geac policymaker because India is not

52

a major GMO exporter. The situation might change in the future as more GMOs reach the market

stage. Geac policymaker stated that India ratified the Protocol for the purpose of research and to

control intentional release because “when you are an exporter you have to meet with their

compliance but if you are an importer you need to put in certain mechanisms in your country”.

7.2.4. OTHER REGULATORY BODIES

There are other bodies involved in Indian GMO governance under the Rules, 1989:

• Recombinant DNA Advisory Committee (RDAC), under the DBT it prepares suitable safety recommendations and reviews developments at national and international level.

• State Biosafety Coordination Committees (SBCC), co-ordinates and monitors GMO activities

in the state with the central ministry. • District Level Committees (DLC), monitors GMO activities in their district. The DLC and SBCC operate at regional level and will only be involved in the monitoring

process. They will supervise the inspectors who monitor the trials and might attend the GEAC

meetings when required. The MoEF regularly trains inspectors in order to increase personnel

capacity and enforce implementation, which remains a challenge in India.

7.2.5. THE BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA (BRAI)

The Department of Biotechnology (DBT) is to set up a Biotechnology Regulatory Authority of

India (BRAI) that would provide a single window mechanism for biosafety clearance. In May 2008,

the DBT issued a draft ‘National Biotechnology Regulatory Bill’ and a draft for the “Establishment

Plan for Setting up the National Biotechnology Regulatory Authority”. Interestingly, there is a

clause in the proposed Bill where “misleading the public about organism and products” is subject

to punishment.

Following inter-ministerial consultations with different stakeholders, the DBT subsequently

drafted a revised ‘Biotechnology Regulatory Authority of India (BRAI) Bill, 2009’, to be submitted

for approval to Parliament. Until the proposed BRAI becomes fully functional, the existing

regulatory mechanisms under the EPA, 1986 and Rules, 1989 will continue to be in force. It is

proposed that BRAI should initially have 3 regulatory branches:

1. Agriculture, Forest and Fisheries Branch (AFFB) 2. Human and Animal Health Branch (HAHB) 3. Industrial and Environmental Applications Branch (IEAB) The laws of this body are currently under the Court and will be expected to come into force by

the end of this year. Like the Food Standards and Safety Authority, BRAI will fall under the

Ministry of Health and Family Welfare (MHFW), which will provide administrative support.

53

8. THE REGULATORY FRAMEWORK IN CONTEXT

P.K. Ghosh (2002) stated that biotechnology is a highly competitive field and only countries

with a competitive edge will be able to benefit from this market. He believed that “Countries must

ensure that they have the necessary technological and legal structures in place and we believe our

policies and preparation are moving India in the right direction” (PK Ghosh, 2002). Therefore, it is

to be expected that the investments by the Indian government on GM technology are

complemented with a complex regulatory framework for the approval of GMOs.

Currently at the R&D stage, research projects for both food/feed and pharmaceutical

applications fall under the surveillance of the IBSC of each research institute and will be approved

by the RCGM (within the Ministry of Science and Technology). Once the application is ready for

commercialisation, it will be the responsibility of the GEAC (within the MoEF) to approve it for

release into the environment. When the GMO reaches the commercialisation stage, it is the

responsibility of the SBCC and DLC of the state/district where the GMO is being produced to

ensure the industry’s compliance with the legislation through regular monitoring. Although at first

instance this system might seem to promote competition among the different committees, in

practical terms the policymakers interviewed not only highlighted what they saw as the excellent

levels of collaboration among the committees but Rcgm policymaker added “practically speaking,

we are lucky that so many ministries are involved…if somebody makes a mistake, the other person

may take care of”.

The regulatory framework however, has received severe criticisms by the media. The Times of

India wrote “its babu-heavy regulatory panels are perceived to favour the seed industry, and the

existing mechanisms for assessing field trials and crucial post-release monitoring of GM crops

inspire no public confidence”27. ENGOs are even more critical of the GMO regulatory framework

and highlight the lack of penal/legal enforcement (e.g. Nav Bharat Seed Company was never

penalised for releasing illegal Bt cotton), deficiencies in the monitoring system and the lack of

provision for public participation28. The latter point is challenged by a Geac policymaker who said

that GEAC provided an opportunity for other stakeholders (e.g. industry, ENGOs, regional

governments) to present their views on case specific issues or on request.

More objective external reviews have recognised that the system is able to ensure the

biosafety of any released GMOs but point to certain pitfalls such as the overall length of the

process, the procedures are not always in line with international guidelines and the overlap of

functions among the different committees (RA Mashelkar, 2005). In response to all these critics,

the Indian government decided to set up an independent scientific body (i.e. BRAI) to regulate not

only GMOs but all the applications of biotechnology and to simplify the approval process through

a single window approach. In addition, BRAI will also address the transparency issues as “the

decision-making process will be totally independent” (Indscientist). Geac policymaker stated that

the creation of BRAI aims “to be more facilitative and to have more level of preparedness…it is

27http://epaper.timesofindia.com/Default/Layout/Includes/ET/ArtWin.asp?From=Archive&Source=Page&Sk

in=ET&BaseHref=ETD%2F2009%2F11%2F24&ViewMode=HTML&GZ=T&PageLabel=11&EntityId=Ar01100&A

ppName=1 28

http://www.genecampaign.org/Publication/Article/gmo-reg-india-weakness-p1=ID1.htm

54

very important to have institutions with their own departments with well-trained staff to go

through all the proposals”.

All interviewed stakeholders were positive that the Indian regulatory framework had

increased the country’s competitiveness. In fact, India changed from being a cotton importer to a

major cotton exporter after the introduction of Bt cotton. They were also positive on the

protection of the environment but stated that the implementation had proven challenging

although it was not exclusive to GMOs “India is such a big country…whatever you do, it is like a

needle in a haystack” (Geac policymaker). Both Rcgm and Geac policymakers identified capacity

building as the major limiting factor although this was slowly improving through the employment

of more qualified people for RCGM and the training of inspectors on how to monitor GM fields.

The attention that GM food/feed applications receive when compared to the pharmaceutical

applications is similar to the position observed in the EU. Indeed, a lot of anti-GM campaigns on

GM crops have used the EU case as an example. Based on the 2 GM approved by GEAC in India (Bt

cotton and Bt brinjal) we will briefly describe the current Indian GMO governance for GM food. As

with the EU, recombinant medicines have escaped anti-GM campaigns. Overall public acceptance

combined with a continuous R&D investment have been important factors in positioning India as

a global player in the red biotechnology market.

8.1. FOOD AND FEED SECTOR

The government’s investment in GM technology for food applications has resulted in 21 crops

with 27 traits in the pipeline (Bt okra, Bt cauliflower and Bt cabbage will be the first ones to follow

Bt brinjal). Overall there has been an evolution in the type of technology used, changing from a

focus on already approved varieties (e.g. Bt cotton), adapting existing traits to national needs (e.g.

Bt brinjal) to working on their specific needs with drought-resistant rice with an inserted

mangrove gene (in collaboration with researchers in the Philippines).

Both, the risk assessment and risk management stages are entangled in India with numerous

committees involved in the approval and monitoring of each GMO. Although no food/feed GM

crop has been approved, India has extensive experience on the issues surrounding GMO

governance. Indeed, the cultivation of Bt cotton since 2002 has fuelled the development of the

agro-industry with the presence of both international (Monsanto, Dow, Pioneer) and national

companies working in the development of numerous cotton hybrid varieties.

The Bt cotton experience in India has reached the international arena and ironically, it has

been used simultaneously by industry (as an example of success and poverty alleviation) and

ENGOs (as an example of failure and economic trap for vulnerable farmers). Although it was

officially approved by the government in 2002, it had already been planted illegally in some areas

2 years before. This by chance was the key factor in its fast acceptance as Geac policymaker

explained “in 2000 there was major pest infestation and the entire crops, cotton crops in the

country had failed, but these few locations in Gujarat which was cultivating illegally they did not

succumb to the pest infestation”. After this event, farmers put pressure the government for the

approval of the GM varieties and some even threatened to plant it illegally as a sign of protest, if

55

GEAC denied Mahyco’s (Monsanto’s Indian partner) approval for commercialisation (N Raghuram,

2002).

During the initial period of Bt introduction though, GM seed availability was limited and the

demand was very high, which promoted the creation of an illegal market with the growth of

spurious seeds. In addition, prices were too high for the small farmer. The government’s

intervention (especially at state level) helped to reduce the price by half and the distribution of

numerous sub-licences. These policies rapidly increased the availability and the quality of hybrids

in the market. Following this, acceptance grew steadily and Indscientist estimated that around 80-

90% of cotton currently cultivated in India is Bt. The demand of Bt varieties has given a boost to

the national biotechnology economy with an increased number of partnerships between research

and industry29 and between international and national companies. For example, Monsanto made

an agreement with the Indian company Mahyco for the commercialisation of Bt cotton and

allowed Mahyco to use the patented Bt gene for 4 crops, including the recently approved by GEAC

Bt brinjal.

Nevertheless, the explosion of the hybrid market ended up being a difficult time for farmers

because Rcgm policymaker noted “when you flood hundreds of hybrid in the market the farmer

just doesn’t know which is to buy…every company has its own marketing studies and advertising

strategies, convincing strategies, and then they have the local folks…they *farmers+ just ask ‘which

is the hybrid we should breed?’…naturally because no farmer want to take a risk…they *farmers+

will go to the last year hybrid and quite possible that hybrid doesn’t perform”. Therefore, the

farmers have become the target of seed companies, which will follow a different array of

strategies, most notably donating seeds to important regional farmers for demonstration plots

(“local folks”, as stated by Rcgm policymaker). The saturation of the seed market has also been

noted with a high number of new seeds appearing each year into the market. In fact, some seeds

that have lost their popularity have also been reported to have been brought back to the market

under a new name (GD Stone, 2007). The farmer’s situation is better explained by G. Stone: “a

better metaphor would be a chef whose job is to continuously develop new dishes in a kitchen

where someone keeps changing the labels on the ingredients and the stove will not hold a

constant temperature” (GD Stone, 2007).

Illegal trade is therefore one of the biggest issues that the Indian government is facing with

regard to the GMO governance. The government has run a series of workshops to inform farmers

and to inform state agricultural universities on how and what to communicate to farmers. In

addition, there are plans to modify the package of GM seed to avoid fraud. However, this problem

is unlikely to disappear easily owing to the levels of poverty embedded in the farmers’

communities as stated by Indscientist “if there is a package of seeds which is sold at 100 and

another one which is sold at 25 the package looks identical and the dealer also tries to push it

giving a convincing argument. Quite a few farmers will go for cheaper option”. Illegal trade is not

only an issue at the cultivation stage, for example in 2009 Greenpeace found traces of Mon863

and NK603 (both unapproved in India) in packets of Doritos potato chips that had arrived in

29 Indscientist explained that is not uncommon that Indian Universities give the rights for commercialisation

to Indian companies.

56

certain supermarkets through an independent importer via Mumbai30. Geac policymaker also

showed some concern on future external trade disruptions stating “I feel when you are about to

be an exporter or importer certain regulations you might bring in your country might be construed

as a trade barrier”.

Another trade-related problem is the lack of co-existence measures as most farmers’ plots are

too small and too close together to apply e.g. isolation distances. Another consequence of small

fields is the inability to adhere to the 20% non-GM refuges to prevent pests to become resistant

to the Bt toxin. Furthermore, there are no tracking and labelling possibilities because vegetables

are sold at open markets. This is not seen as a safety concern. As Rcgm policymaker, in line with

EPA and EFSA interviewees’ opinions, said “we don’t believe in traceability. We believe only one

thing, either that should be GM or should be no GM. Because if we are going to approve

something, that means it should be the safest”. However, the Indian government may need to

take into account the cases of Bt resistance already detected in the USA by EPA. With the reduced

size of the cultivation plots in India, it is impossible to promote the non-Bt refuges needed to

avoid Bt-resistant pests and therefore, other alternatives such as “refuge in the bag” (with a mix

of GM and non-GM seeds in the same package) could be considered31. There are also growing

fears that introducing GM food crops could affect the export of food products due to the inability

to introduce co-existence measures. This is particularly important for the existing EU market, as

currently India is GM-free. Without segregation and traceability measures in place, India could

lose the EU market if the cultivation of GM food crops increases.

Trade-related issues have not been the only factor to influence Bt cotton regulation. Both the

media and NGOs played an increasingly important role in the Indian GMO debate. Rcgm

policymaker claimed that the growth of NGOs in India is correlated with Bt introduction. The

Indian activist movement is composed of a large array of organisations led by charismatic leaders

but with different goals. Attempts to unite all these organisations under a single anti-GM umbrella

have failed mainly due to personality clashes among NGO leaders (I Scones, 2008). As Rcgm

policymaker sceptically noted “If you look at the TV channels you will find every day a new guru

will talk something about anti-GM [Genetically Modified]. He will talk something about what is

GM [Genetically Modified]. Then, he will have a GM [General Motors] car”. Activists are

themselves well-educated urban citizens who successfully sell their agenda to developed

countries and vice versa. This has been extensively reported by academic literature and was

confirmed by all the Indian interviewees.

Indian activists tend to portray a romanticised vision of agriculture whilst targeting wealthy

metropolitan citizens (R Herring, 2009). This view contrasts significantly with the reality of the

deprived communities in the rural areas. After the official approval in 2002, farmers had some

mixed opinions regarding GMOs. Some accepted the compensation from the activists for the

destruction of their crops whilst others contacted the police (I Scones, 2008). For example, in the

Karnataka monitoring committee report there is a mention that “some of the farmers have

expressed their apprehension that environmental activists in the State might uproot their Bt

cotton crop. Hence they have not taken up Bt cotton crop though they are interested due to its

30 http://www.hindu.com/2008/05/23/stories/2008052359971300.htm

31 http://www.epa.gov/nrmrl/pubs/600r10055/600r10055.pdf

57

high yields32”. The social gap between the rich well-off urban areas and the poor country side

added to the inability to provide a cohesive anti-GM message meant that Bt cotton was not

banned. Rcgm policymaker noted that “they [farmers] have understood that they [activists] have

their own motive so they are angry with them, and especially the Northern India farmers. They

[farmers] are not only progressive, they are aggressive also”.

With the Bt cotton success as a reference and the trading conflicts in the background, Bt

brinjal entered into the GMO debate after the final approval by GEAC in October 2009.This time

however, the activists reacted faster and were better organised. There are already claims that Bt

brinjal “reduced the appetite in goats, increase prothrombin time in goats and rabbits and caused

the plants to produce a protein inducing resistance to the antibiotic kanamycin”33. Fuelled by

ENGOs and media, the general public is more reticent to brinjal than cotton because it would

enter the food chain. Indeed, the results of the public consultation triggered in February 2010 the

moratorium on this GM crop by Mr Ramesh (minister of the Environment and Forests).

The approval process by GEAC was mainly criticised for not following the biosafety guidelines,

for the lack of long-term studies and because the samples were analysed by private laboratories

(this was denied by Indscientists who said that 3 different institutions were involved in the

assessment of the samples). Geac policymaker explained that activists asked for chronic toxicity

studies although these are not even carried out in the EU or USA. With regard to this decision,

Indscientist stated “scientists that work in the area thought this was not the right way at all

because what happened is that the regulatory process has gone through, it’s what the

government itself has set up and the approvals were given by the experts who were themselves

appointed by the government itself”.

On the other hand, the environmental concerns surrounding the release of Bt brinjal are

significant as some believe that India is the centre of origin for this vegetable; some wild varieties

of brinjal can be found in North-East India34. With currently 2,500 varieties of brinjal cultivated in

India 35 it is difficult to believe that there will be no gene flow between Bt brinjal and its wild

counterparts. Indeed, in addition to the existing poverty levels, Indian policymakers need to take

into account the effect on the environment as India is one of the most biodiverse countries in the

world 36with 2 of the world’s 25 biodiversity hotspots (world's biologically richest and most

threatened ecosystems)37.

It was in response to the moratorium that the government became engaged in risk

communication with the general public. Among other strategies developed was highly informative

and objective outreach material such as ‘National Consultations on Bt brinjal: A primer on

concerns, issues and prospects38’ produced by the Centre for Environment Education (under the

32 http://www.envfor.nic.in/divisions/csurv/geac/mmkr.pdf

33 http://www.nature.com/news/2009/091019/full/4611041a.html

34 http://www.ikisan.com/links/ap_brinjalHistory.shtml

35 http://www.sgm.ac.uk/pubs/micro_today/pdf/081006.pdf

36 http://ces.iisc.ernet.in/hpg/cesmg/indiabio.html

37 http://www.biodiversityhotspots.org/Pages/default.aspx

38 http://moef.nic.in/downloads/public-information/Bt%20Brinjal%20Primer.pdf

http://www.ikisan.com/links/ap_brinjalHistory.shtml

http://www.sgm.ac.uk/pubs/micro_today/pdf/081006.pdf

http://ces.iisc.ernet.in/hpg/cesmg/indiabio.html

58

Ministry of Environment and Forests) as well as the organisation of numerous workshops.

Indscientist, who participated in some of these public workshops, was very positive about the

experience saying “I think what happened from the government side and also from the scientists,

one area which we did not put heart and soul is on risk communication. We would only react to

the activists’ objections but on our own…try to educate the people right from the beginning from

the R&D itself”.

This attitude is common in India, where all interviewees were used to defending their views

against other stakeholders. Rcgm policymaker said that stakeholders “will write letters, they come

personally, they will make some complaints. They will seek information under the Right to

Information Act, so all things are there and we are open, we have no problem” and similarly, Geac

policymaker stated with regard to the Bt brinjal case “it will be definitely such a big public

consultation. Whether it is genuine or not genuine or whatever thing…but it will be welcome

also…if there are some things we need to strengthen you can always do that and it will be always

welcome when these measures are taken to a public concern”. Unfortunately, the complexity of

the science is seen as a barrier by Geac policymaker, especially in a country with high levels of

illiteracy, and stated “you cannot go, you cannot sort of raise the public opinion based on scientific

facts” and added “how to address the perception is really going to be difficult”. However, the

results from these workshops seem to already be visible as media, another key player in the GMO

debate, has changed its position “I think the media itself is now taking a fairly balanced view and

then that hysteria was hold on the opposition’s seems to be stopping giving therefore more

reasoning” (Indscientist).

The Indian government is at a critical point where the advantages of GM food crops (food

security, income for farmers) need to be balanced with its risks (gene flow, public rejection).

Unlike in the EU or USA where socio-economic values are present only at the risk management

level, in India they are already present at the R&D stage. Indeed, Geac policymaker explained that

“socio-economic value should not come whether we need brinjal or we don’t need brinjal. I think

this should have come much before…these products are very capital-intensive and I don’t think

developing countries have that kind of money to throw out wherever you know. You would get

into philosophical issues”.

8.2. PHARMACEUTICAL SECTOR

India is emerging as a global actor in the biotechnology industry. In the 2009-10 financial

year, the biotech industry showed a 17% growth over the previous year with biopharma being the

biggest contributor (generating 60% of the total growth)39. Indeed, India is the largest producer of

recombinant Hepatitis B vaccine (P Arora, 2005). The good health of the pharmaceutical industry

was confirmed by Indscientist who stated they receive for approval 20 to 24 pharmaceutical

applications monthly. However, there are still some difficulties that need to be overcome to place

India among the top biotech countries such as the concentration of most of the research in only 4

39http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/biotech/Indian-biotech-industry-

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states (P Arora, 2005) and only around a dozen organisations that qualify as centres of major R&D

from a total of the 250 universities (G Padmanaban, 2003).

Another major challenge has been the cumbersome regulatory procedure. According to the

‘Task Force on Recombinant Pharma’ report (RA Mashelkar, 2005), there are several problems

that affect the risk assessment and management procedure of the GMO pharmaceutical

applications. These included the lengthy process of approval through multiple approval systems,

the risk assessment does not fully adhere to international guidelines, the regulatory objective of

different Committees is not clear and the lack of identification of specific environmental impacts

of GMOs for the pharma sector. Recommendations from the Task Force were: the definition of

the responsibilities of the different regulatory bodies, the creation of a stepwise procedure, the

creation of a documentation system that the applicant could submit to the regulatory

Committees/Competent Authorities and the development of a regulatory body with a single

window approach. With the creation of the new Biotechnology Regulatory Authority of India

(BRAI), it is to be expected that all the issues identified in the report will be tackled and the

regulatory process will become more efficient.

Indian acceptance of GM pharmaceutical applications follows a similar pattern to those in the

EU and USA. In fact, edible vaccines are seen as a promising solution to overcome storing and

administrative hurdles (N Misha et al., 2008). It is thus not surprising, that all Indian interviewees

were highly supportive of these applications.

Finally, the Indian government has numerous international collaborations in biotechnology.

The USA is their most important collaborator with the Indo-US vaccination programme, the

agrobiotech joint working group and the technology programme. In addition, there is an Indo-EU

joint working group on biotech pharmaceuticals that has been functioning for over 5 years and a

strong collaboration with the Philippines. Moreover Indian policymakers draw upon experience

on GMO governance from US, Canada and Australia (the first two were key for the Bt cotton

regulation).

9. GM ANIMALS IN INDIA

Despite the strong governmental investment in GM plants, there is currently no GM animal in

the pipeline in India. There are some rumours that scientists from the Madurai Kamraj University

created the first transgenic fish (rohu) in 199140. Furthermore, the Financial Express claims that

ICAR is involved in the development of several transgenic fish and 3 species: zebra fish, cat fish

and singhi fish, are currently at the R&D stage21. However, Rcgm policymaker was confident that

the rohu fish project had been cancelled some time ago. Despite some recent news that a

transgenic fowl was also being developed, when Rcgm policymaker enquired about it to the

Hyderabad-based project directorate on poultry they denied it as “some people make such

statements and when they fall in trap with the regulators then they say they it is just for publicity”.

This attitude is certainly not due to the government’s view of the technology since all

interviewees mentioned the benefits of nutritionally-enhanced animals.

40 http://www.gene.ch/genet/2004/Mar/msg00111.html

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With regard to the GMO regulatory framework, it is broad enough to include animals

although there is a need for specific guidelines for the risk assessment. Nevertheless, India faces

certain regulatory challenges common to developing nations with implications for GM animal

governance: keeping up-to-date with the scientific advances, lack of capacity for the risk

assessment stage and the implementation of the regulations. With the creation of BRAI, it is

expected that the government will be able to regain the public trust and the approval process will

be more efficient, both key elements for the successful introduction of GM animals.

Despite the Indian government’s experience of risk communication, GM animals pose certain

challenges. These are likely to be particularly acute in India because of the stronger religious

linkage between animals and humans in the Hindu and Buddhist communities and the existing

cultural diversity. This is especially true for animals such as pigs and cows. All interviewees stated

that no modification on pigs or using pig genes would be viable in India as there is a significant

Muslim population. They were more positive though with regard to Hindu attitudes towards

transgenic cows: all interviewees believed that unless they are killed they would be accepted.

Another cultural factor is the high prevalence of strict vegetarians who will not accept any animal

gene constructs (there were already concerns on Bt plants as the Bt gene is from a bacterium). For

example, the Omega-3 fatty acids used to add nutritional value in foods which is extracted

worldwide from fish, in India is produced from algae.

Surprisingly, there were no concerns from the activists’ movements about transgenic animals

as “there is no money in animal” (Rcgm policymaker). In fact, all interviewees believed that NGOs

campaigns are funded by external donations from interest groups (pesticide companies and

organic farmers) and could not foresee any funding stream available for the anti-GM animal

campaigns. It remains to be seen whether the breeding industry will embrace GM animals

because, based on the experience in US and EU, there is a lack of venture capital investment in

these applications.

A further issue regarding the development of GM animals is socio-economic. Sceptics on the

practical uses of these applications claim that “India, where about 250 million people remain

partially or fully hungry, not because there is no food grain in the country, but because they have

no purchasing power” (PC Kesavan and MS Swaminathan, 2005). The authors, using the ruminant

industry as an example, differentiate between the ‘mass production’ seen in developed countries

from the ‘production by masses’ seen in India, similarly to the Bt cotton cultivation. They defend

that the most serious shortfall in animal breeding is the low quality of the feed and its negative

impact on the health of the animal. For example, r-BST cows which increase milk production by

10-20%, were shown by US researchers to have no harmful effects on the animal if properly fed

(as higher level of milk production implies more food). This would clearly be impossible in India

due to the low quality of fodder and forage crops.

As expected, a very different situation is seen in the pharmaceutical applications. There is a

bioreactor already approved (a goat that produces blood factor VIII) and the government

welcomes these types of applications due to the benefits for the country’s economy and the

Indian population. Rcgm policymaker even stated that “there is no issue of religion, there is only

issue of health” when mentioning possible issues with insulin produced by pigs for the Muslim

community. In addition, for practical reasons, India is more relaxed with regard to secondary uses

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of GMOs. For example, despite the toxic claims by Indian NGOs (i.e. although never scientifically

proven, there are reports on goats intoxicated after eating Bt cotton leaves), the oil extracted

from the Bt cotton seed is commonly used for human consumption. The Times of India noted that

“GM technology has already entered the food chain since cotton seed oil made from Bt cotton is a

cooking medium in India ‘In the last seven years, have you ever heard of someone dropping dead

or falling ill because of this?’ he [KK Tripathi] says41”. In the poorer rural Indian communities,

Indian policymakers are well aware that farmers traditionally extract oil from the cotton seeds.

This fact is taken into account in the approval process and there are no safety concerns as the

toxin was shown not to be present in the oil. Therefore, unlike in the EU, there was no

apprehension of possible secondary uses of GMOs as long as these are scientifically proven safe.

The concerns of Agri policymaker on the consequences of the European meat industry if a

bioreactor reaches the food chain were not shared by the Indian interviewees. Given this

environment, the animal biopharming industry could have a future in India for bioreactors whose

consumption is proven safe. Indian policymakers however, would still need to take appropriate

containment measures for certain Living Modified Organisms (LMOs) in order to protect the rich

Indian biodiversity.

In conclusion, provided that certain precautions were taken (e.g. containment measures or

avoiding pig genes/animals) interviewees did not foresee any major disadvantages to this

technology. However, Indian civil servants remained cautious whilst observing the evolution of

the global market on GM animals. As the government is just starting to obtain the first benefits of

the economic investments in GM crops, its priority is to ensure that these products reach the

market and benefit the Indian population.

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INTERNATIONAL CONTEXT

10. INTRODUCTION TO THE INTERNATIONAL ORGANISATIONS

The number of international organisations has grown steadily since the last century with a

constant increase of status and impact such as the recent role of the WHO in responding to Avian

influenza. Frequently they are used as platforms for the views of nation states, industry and

ENGOs. One of the reasons for their success is their role as relatively neutral arenas for open

discussions on conflicting topics among member states. Under the auspices of their offices,

member states meet, share their views and influence global policy. As Sanco policymaker stated

“what is always difficult in the international arena is who shapes what because of course we

negotiate also, what is the text that comes out of Codex so we shape the text of Codex, and it’s in

both directions that it works”.

Given the contentious nature of the GMOs, it is not surprising that many international

organisations have organised workshops, working parties or committees to tackle the key

international governance challenges that GMOs pose to member states. Some of these

international bodies have focused on the development of scientific guidelines for the risk

assessments such as the OECD and CAC. Others have played the role of implementing

international agreements (e.g. GEF for the Cartagena Protocol). Finally, there are some bodies

with no direct involvement in GMOs which have been brought into the debate through indirect

means: for example, the WTO became involved in the GMO plant debate as a result of the

increased number of agricultural trade disruptions.

We will describe in the next section the international bodies that have played an important

role in the GM plant debate and that are therefore likely to have an influence on the formation of

GM animal regulation. The aim is to identify their positions on the GM issue, their major

interactions with each other and the major stakeholders with whom they engage.

10.1. Organisation for Economic Co-operation and Development (OECD)

Founded in 1961 the OEDC is an international organisation that aims “to help governments

foster prosperity and fight poverty through economic growth and financial stability”. Currently it is

formed by 33 member states, most of them from high-income economies. Moreover, the

signatory states have given the EU a “quasi-Member” status. The strong EU presence in the OECD

has clearly had an influence in some areas such as the approach to the environment and, more

specifically, the strong collaboration between the OECD and the secretariat of the Convention of

Biological Biodiversity (CBD), ratified by the EU in 2002. The USA is also a member of the OECD

and India is one of the 5 states belonging to its enhanced engagement programme.

The OECD has a key role in harmonisation of the scientific terminology and the development

of scientific guidelines in numerous topics, including biotechnology. Unsurprisingly, biosafety is an

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important matter as a result of the synergies between this organisation and the Cartagena

Protocol (under CBD’s umbrella). The OECD set up in 1995 a Working Group on the Harmonisation

of Regulatory Oversight in Biotechnology and in 1999 a Taskforce for the Safety of Novel Foods

and Feeds. Rtd policymaker recognised the role of OECD in development of biotechnology: there

is a need “to find a common language…otherwise you cannot really, on an international level,

proceed when you always talk about different issues”. Interestingly, the OECD is the only

international body that uses the US system of nomenclature for transgenics: Genetically

Engineered (GE) rather than Genetically Modified (GM).

The key role of the OECD on global harmonisation was recognised by all interviewees. It was

especially important at the risk assessment stage, where the term “substantial equivalent” was

first coined in 1991 and has been the cornerstone on the safety evaluation of GM crops.

Moreover, harmonisation is not only helpful at the R&D stage but also for trade and, in this

regard, the OECD has been involved in activities such as standardisation of tests to identify GMOs

and the development of “consensus documents” with key biological information on the major

crops which are globally accepted as the comparator for the substantial equivalent tests.

The OECD membership includes the strongest players in biotechnology research. It is not

surprising then that the OECD has regularly been one of the first international organisations to

tackle novel biotechnology issues including GM animals. For example, probably in response to

AquaBounty’s salmon entering the approval system in the USA, a Working Group is already

developing a consensus document on the biology of salmon.

10.2. World Health Organisation (WHO) and Food and Agricultural Organisation (FAO)

The WHO (founded in 1948, 193 member states) is the directing and coordinating authority

for health within the United Nations system whereas FAO (founded in 1943, 119 member states)

leads international efforts to defeat hunger. Unlike the OECD, both the WHO and the FAO have

representatives from developed and developing countries. This broadens the debate and provides

a more balanced view on the selection of topics that need attention. Both organisations have a

long history of collaboration on global issues such as pesticides, nutrition and GMOs.

The Department of Food Safety and Zoonoses within the WHO deals with food biotechnology

although Who employee clarified that “currently there are 0.5 members of staff working on this

topic”. Nevertheless, WHO/FAO has held several expert consultations on the safety of GM foods

from plants, GM microorganisms and on allergenicity. In addition, the WHO/FAO held an expert

consultation on the safety of GM animals (including fish) in 2003 which was reviewed in 2007.

Nevertheless, the WHO has no plans to work on GMOs in the near future. According to Who

employee this is firstly because there are more important global matters. Secondly, Who

employee explained that the last WHO/FAO meeting in 2005 concluded that there was a need to

create a holistic approach to GMOs (including environment, socio-economic and ethical issues)

but this proposal received no response from any member state, terminating the organisation’s

work on this topic.

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The WHO is approached by different stakeholders on GMO’s issues, besides member states.

These are mainly producers and biotech companies and to a lesser extent by ENGOs and

consumer organisations. Very rarely does the department get contacted by scientists.

It was the Who employee’s opinion that the discussion regarding GMO’s should be more

balanced (i.e. both risks and benefits should be debated) and, in particular, discussions should

take into account the benefits that GMOs applications can have in improving the livelihood of the

poorest. Who employee was particularly concerned over the political isolation of the EU with

regards to GMOs, which he considered were not inherently dangerous (although WHO supports a

case-by-case approach).

9.1.1. CODEX ALIMENTARIUS

Codex is an excellent example of collaborative work between WHO and FAO. The Codex

Alimentarius Commission (CAC) was created in 1963 as an international forum for scientific

discussions on food safety issues. CAC has developed numerous scientific standards to act as

baselines for member states that are willing to translate them into their national legislation,

ranging from food additives, processed foods, to foods derived from biotechnology. Codex has

rapidly become a global reference for matters surrounding food safety as stated in the 2002

internal review, and this was confirmed by all interviewees. All the guidelines are non-binding and

based on the latest scientific knowledge although they are very trade-oriented as Codex is also

used as a reference on food safety disputes under the SPS Agreements (see more at section

10.3.1).

There are currently 183 member states, one member organisation and over 200 observer

organisations that ensure the participation of civil society although the final voting is only

accessible to member states. Transparency was seen as a key feature of Codex by Cac employee:

“openness of the meetings to the public is the most important part of the Codex internal/external

communication strategies” and there is a good level of collaboration among the different

stakeholders “as there are no main players and they are all interacting”. This open attitude might

also be in response to the previous criticisms received regarding the development of guidelines on

vitamins and mineral supplements42.

Interestingly, CAC has not been attacked by ENGOs despite its work on the creation of an Ad

hoc Intergovernmental Task Force on Food Derived from Biotechnology (TFFDB). On that point,

Cac employee clarified that “one of the most impressive things in Codex is the participants’

goodwill to work together”. This Ad hoc group produced a set of scientific guidelines to analyse

the safety of GMOs which have been translated into national legislation in the EU and in India and

recently in USA on GM animals. The Codex also produced a set of guidelines for GM animals in

2008 as it was one of the issues raised in the first meeting of the TFFDB.

42 In 1996 the German delegation put forward a proposal that no herb, vitamin or mineral should be sold for

preventive or therapeutic reasons, and that supplements should be reclassified as drugs. The proposal was agreed but not without controversy. Opponents have spread rumours through internet which among other things, claim that Codex guidelines want to ban herbs and natural remedies.

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Codex is also involved in other related activities such as detection methods for recombinant

food and protecting consumers against practices such as deceptive labelling. CAC has tried for

more than 10 years to arrive at a consensus on the guidelines for labelling GM food but without

success. The discussions have been so lengthy and controversial that H. Yoshikura, former Chair,

Taskforce on Foods Derived from Modern Biotechnology, Codex Alimentarius produced a report

by compiling previous debates in CCFL and in other Committees/Taskforce in Codex Alimentarius

(2009, unpublished). This report stated in the preface: “such a document is necessary because the

‘GM debate’ lasted so long that many of the delegates present in the early meetings left the

committee and were replaced by new delegates. The continuity of the debate is often lost”.

Therefore, GM labelling stands as one of the most controversial topics regarding GMOs where

international consensus has yet to be reached, probably as a result of its significant economic

implications.

10.3. World Trade Organisation (WTO)

The WTO, which currently consists of 153 member states, acts as a neutral forum where

member states resolve their disputes over trade. The guidelines used to settle these disputes are

the SPS Agreements, TBT Agreements and TRIPS which were finalised during the Uruguay Rounds

and cover tradable goods, services and intellectual property (see following section for more

detail). The WTO however, is currently the host to the production of new regulations under the

Doha Development Agenda.

The Secretariat has a very detailed and well-structured system to resolve disputes under the

Dispute Settlement Body, which can establish a panel of experts if considered appropriate (i.e. for

highly technical issues such as biotechnology). Once the final decision is made, member states

have the right to appeal for a limited period of time or otherwise the dispute is considered closed.

This system has been shown to be highly efficient which added to the strength of the WTO

Agreements. It has become a preferred method for dispute settlement on trade-related matters.

The Wto employee believed that the success of the dispute settlement system is based on the

provision of a neutral forum where members can openly discuss whether they comply or not with

the regulations and the Secretariat acts “greasing the wheels of that system and trying to make it

function”.

Interestingly, the WTO has a very restricted access where only member states are allowed to

participate in discussions and it is only through special requests that a member state can invite

stakeholders as observers for specific topics. However, the WTO holds open days and it is possible

for stakeholders to write to the trade disputes though Amicus curiae (for example, there were 3

during the WTO GMO dispute). These depositions will be read by the panel but not taken into

consideration for the final decision. To this extent WTO remains isolated from non-governmental

groups which have to rely on influencing individual member states to bring their agenda forward

with regard to trade. On the other hand, the WTO interacts extensively with other international

bodies such as the World Bank and, on agricultural issues, the FAO. In addition, the Secretariat

will interact regularly with the 3 international organisations that are used as standards in the SPS

Agreements: CAC, OIE and IPCC.

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WTO has also received criticism because of its strict views regarding free trade and the

potential conflict between this and concepts such as environmental protection or sustainable

development. The interviewee recognised that these latter issues were not taken into account in

the Uruguay Rounds but following Doha it was clear that there was a need to adapt to the

changing political climate. Sustainable development is easier to deal with the WTO as countries

can use the Uruguay Rounds agreements for their own benefit because “there’s such a diversity of

interests in the members so every member will use the organisation in the way it sees right”.

Environmental protection however is more complex to take into account within the existing

agreements. The Wto employee recognised that the only solution would be the re-opening of the

agreements and the WTO is very resistant to re-negotiate them (the Uruguay rounds took 9 years

to finalise). Instead, the WTO prefers to keep its competences on trade and asks countries to

solve their disputes through the environmental agreements, restricting the use of the WTO

system to the situation where one of the countries has not ratified it. Nevertheless, some aspects

such as plant invasiveness are covered by the International Plant Protection Convention (IPPC).

The Trade and Environment Committee was also created to study and advise on the relationship

between trade and environment.

One of the main challenges that the WTO faces is involving small countries in the discussion.

As the Wto employee said “they just don’t even have the numbers of people”. As member states

are entitled to training, the Secretariat will often help such countries by working with them

through the implementation questions.

The Wto employee clarified that the WTO does not have a position on GMOs on the basis that

it deals only with trade. The WTO website encourages countries to follow international standards

when available. As long as a state can prove that its safety measures are equivalent to those of

the importing country, then this country is expected to accept the GM products. However, there

were some issues concerning GMOs which were of particular concern, such as the level of

accidental presence that is allowed or if it is reasonable that the international system becomes

less tolerant as detection tests increase in sensitivity. The Wto employee also reflected on the

difficulty of quantifying the risk of introducing GMOs in a non-GM shipment.

10.3.1. SPS, TBT AND TRIPS AGREEMENTS

The WTO has around 60 binding agreements that member states must ratify upon accession.

Among these agreements, there are 3 that are associated with GMOs: SPS Agreements, TBT

Agreements and TRIPS. The Sanitary and Phytosanitary (SPS) Agreements cover food safety

(including labelling), animal and plant health on imported pests and diseases. Closely linked to the

SPS Agreement, the Agreement on Technical Barriers to Trade (TBT) focuses on ensuring that

there are no unnecessary trade restrictions due to the technical regulations, standards, testing,

and certification procedures. Finally, the Agreement on Trade Related Aspects of Intellectual

Property Rights (TRIPS) sets the minimum standards to protect intellectual property. Overall, the

WTO agreements have proven to be both solid and able to adapt to changing circumstances (see

next section for more detail).

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Food safety issues related to GMOs could fit under the SPS Agreements although there is not

a specific category for biotechnology-related risks. Furthermore, the SPS Agreements only allow

countries to take provisional precautionary measures in the case of scientific uncertainty and until

additional information is actively sought within a reasonable time period. Labelling on the other

hand is covered by both the SPS and the TBT Agreements. If the objective is to protect consumer

health the case would fit under the SPS, if it is to provide choice for the consumer it would fall

under TBT. Finally, TRIPS has been extensively utilised by ENGOs to argue that farmers (especially

from developing countries) are not able to save a percentage of the seeds for the next season and

become dependent on biotech companies as a result of the strong intellectual rights that protect

the different GM varieties.

With regards to its relationship with the Cartagena Protocol, the WTO website states that “the

relationship of the protocol with the SPS Agreement and other international agreements are not

clear”. However, in practice the Secretariat takes a more pragmatic approach and as the Wto

employee noted “*countries] know what they’re committing to and otherwise they wouldn’t sign

on if they couldn’t do it and still be consistent across all their treaty obligations so there’s not a

priori reason to think that they’re incompatible”. Unfortunately, even if the WTO does not feel

comfortable in dealing with environmental issues, the lack of liability and compliance regime in

the Cartagena Protocol (see section 10.4.1) limits its ability to become a reference on disputes

regarding biosafety and international trade, as has already happened in the WTO dispute of USA,

Canada and Argentina against the EC.

10.3.2. GMOS AND THE WTO DISPUTE

As the main trading partner with the EU, the US industry suffered significant economic losses

due to the EC de facto moratorium on GM products. The National Foreign Trade Council

presented a report entitled ‘Looking behind the curtain: The growth of trade barriers that ignore

sound science’43 to the WTO in which they criticised the EU’s use of the precautionary principle

and its impact on the ability of developing countries to achieve food security. The lack of

response to the US concerns from the EU increased the tensions between them. Finally, in 2003,

the US filed a complaint against the EC (WT/DS291). Shortly after that, both Canada (WT/DS292)

and Argentina (WT/DS293) followed in support of the US action. Because none of the accusing

counties had ratified the Cartagena Protocol (which invokes the precautionary principle), the EC

was forced to settle the dispute under the WTO agreements.

There is an extensive academic literature describing this debate from both parties’

perspective which is not covered in this report. The discussions lasted 3 years (the largest dispute

in the WTO history) because each of the GMO applications pending approval in the EU had to be

considered. From the WTO’s perspective this dispute was important because it was the first one

to conclude that undue delays on the approval process could be seen as a trade barrier: an

eventuality which was covered in the Agreements but which had never been used before. In

addition, the dispute was also the first one to conclude that food allergens and (most notably)

43 http://www.wto.org/english/forums_e/ngo_e/posp47_nftc_looking_behind_e.pdf

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biodiversity could fall under the SPS Agreements. The case of biodiversity is especially significant

because the EC was able to consider it a justification for the protection of national territory. This

highlights the adaptability of the WTO Agreements since at the time the Uruguay Rounds were

finalised the word ‘biodiversity’ did not even exist in the normal discourse of ecology

departments.

The appointed expert panel concluded that the EC had not provided enough scientific

evidence to justify the delays under the SPS rules and as a result it was penalised. However, whilst

the final decision was being made, the EC broke the moratorium and approved a series of GMOs.

In 2006, after continuous dialogue with their opponents, the EC reached an agreement with

Canada and Argentina. But the situation could not be resolved with the US and the last official

communication was in 2008. According to Trade policymaker the US agricultural industry was

divided. Some groups wanted to terminate the dispute and to continue the dialogue whilst

others, for instance the maize producers, wanted to pursue litigation. If the latter option had

been taken, it would mean the US would have had to request the WTO panel to assess whether

the EU was complying with the 2006 WTO panel report. At the end of the period, neither of the

parties appealed the case and from the WTO’s perspective the dispute is considered closed.

With regard to the global implications of this dispute, Wto employee stated that not many

countries have approached the WTO about GMOs. Nevertheless, during the dispute there was a

general hold on GMO cultivation as countries (particularly developing countries) were waiting for

the outcome of the dispute.

10.4. Global Environment Facility (GEF)

GEF was established in 1991 as a global partnership among 178 countries, international

institutions, NGOs, and the private sector with the aim “to address global environmental issues

while supporting national sustainable development initiatives”. GEF acts also as the Secretariat for

several environmental conventions including the Convention of Biological Diversity (CBD) and the

Cartagena Protocol on Biosafety.

Once the Cartagena Protocol (CP) entered into force in November 2000, GEF and UNEP

(United Nations Environment Programme) developed a Strategy through the creation of country-

specific National Biosafety Frameworks (NBFs) to help developing countries that are interested in

incorporating biosafety in their legislation. The funding of the NBFs lasts for 3 years during which

time GEF regional co-ordinators will assess the country’s capacity and develop realistic legislation

tailored to the needs of each specific country. The efforts of UNEP-GEF team resulted in 123

countries developing NBFs, acting as a clearing house as well as producing several reports on

topics of interest. Despite the association of UNEP-GEF with activist ENGOs, their approach to

GMOs is surprisingly pragmatic and as is the case with other international bodies, it tends to have

a broader, more balanced view than individual nation states. In fact, UNEP has never taken a

position on GMOs. As Gef employee commented: “if we made an official statement, somebody

would definitely be unhappy, so by actually remaining kind of neutered, rather than neutral, it

allows us to work”.

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UNEP-GEF has always marketed the Protocol as a solution between two opposing forces:

Industry and ENGOs. In practice however this approach has not always worked. As one Gef

employee noted “industry voices were not very happy with us because they thought we were

raising regulatory barriers that were unnecessary, and on the other side there were NGOs who

said we shouldn’t even be supporting capacity building because this technology is evil and should

be banned”. Afraid to become paralysed as a result of the polarised views of both groups, it was

decided that the Protocol would deal with only one representative from each side (BIO for the

industry and Third World Network for the NGOs) which allowed the secretariat to remain

operational. GEF is also approached by scientists who tend to see the Secretariat as misusing the

precautionary approach (some have even verbally attacked the staff). In addition to these groups,

the biosafety unit within GEF is rarely approached by any other interest group, including the

media. Interestingly, the conservation community has not taken an active interest in biosafety

either. Gef employee stated “they have bigger fish to fry. In terms of threats to global

biodiversity, GM is not really where we need to be putting the majority of our resources”.

In 2006, under the new Resource Allocation Framework (RAF) GEF changed its funding

strategy from allocating budgets to the different units which allowed them to decide their funding

priorities, to assigning a budget to each country based on their levels of biodiversity. This meant

that all GEF units, changed from having ‘operational power’ in bringing their own agenda forward

to a more passive approach. Gef employee noted: “we kind of open the door and if they want to

walk through they can”. The biosafety unit feared that with this new approach they were put into

direct competition with biodiversity. In the end however, there were more countries approaching

them than originally envisaged because biosafety is always government-led whereas biodiversity

programmes have ENGOs involved in the implementation. Therefore, by investing in biosafety

“it’s a way of financing something within the government that they otherwise would have trouble

raising the money”. However Gef employee observed of the current situation: “if you are going to

have an international agreement, then it has to be financed…if you don’t support the countries to

participate, then it is not worth having”.

The biosafety unit has been strongly affected by the RAF. The team has been reduced from 16

people with a $50 million budget to 3 regional co-ordinators (based in Geneva, Nairobi and

Panama) acting as project managers “we develop projects, we get a small fee for projects that are

approved, and that just about covers our ability to manage those projects, and keeps us busy

pretty much 9 until 5”. This economic situation is clearly connected to the decrease in the

international rapport of the Protocol since GEF employees do not have the budget to travel to

international meetings any more. On the future of the CP, Gef employee believed it was

“stagnant, I think is the word”.

10.4.1. CARTAGENA PROTOCOL

The Cartagena Protocol (CP) is a non-binding environmental agreement as a supplement to

the Convention of Biological Diversity (CBD). It is based on a system of informed consent in which

the exporter notifies to the country of import when the product contains GMOs. It has two

separate procedures based on whether or not the GMOs will be released into the environment

and has a Biosafety Clearing-House where governments communicate decisions and exchange

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information. The country that is considering the import has the right to ask the exporter to bear

the cost of the RA, although that country will still need to control and manage the risks identified

in the RA. The CP focuses only on Living Modified Organisms (LMOs), as these are the ones that

might present a hazard to the environment (once the LMO is processed for food consumption,

there is no possibility of gene transfer).

K. Toepfer (Executive Director of UNEP) said “global issues, such as trade in genetically

modified organisms, require global, multilateral deals”44. The UNEP therefore has always

presented the CP as the authority on GMO trade. Because there were some fears from member

states on inconsistencies between the Protocol and the WTO agreements, the CP was carefully

drafted to ensure that it neither overrides nor is subordinated to the SPS and TBT Agreements. In

fact, there are some points in common between the SPS Agreements and the Protocol. They both

require a science-based RA and although only the CP will use the precautionary approach, the SPS

agreements also encourage governments to take precautionary measures in case of major

uncertainty. However, whereas the SPS Agreement requires that these measures should be in

place for a limited time until new scientific evidence is gathered, there is no such limitation on the

Protocol. It is important to note though that none of the major exporters of GMOs has ever

ratified the Protocol (e.g. USA).

The Protocol has been criticised for its lack of liability and compliance mechanisms and for

being too ambiguous. Gef employee stated that importers are only required to ensure that their

National Biosafety Regulations are not in breach of anything which is in the Cartagena Protocol

and “that’s quite easy to achieve”. In addition, Gef employee recognised that most of the NBFs

never become operational because governments get “cold feet” due to NGO pressure when they

have to approve the draft law and tend to follow their existing regulatory system (India was

mentioned as an example). Furthermore, if countries have already established biosafety laws

(such as the EU) the Protocol is not useful because it does not have a liability regime. These issues

may be addressed in the draft supplementary Protocol that is expected to be released by October

2010.

A further issue at country-level is that most CP members have their base in the Ministry of

Environment which often does not communicate with other ministries (i.e. health or agriculture)

causing some internal disruption. The Biosafety unit has tried to redress these issues by requiring

a representative from other ministries to be present on the biosafety committees although there

is also a global tendency for Ministries of Agriculture to take over biosafety matters.

10.5. World Organisation for Animal Health (OIE)

The OIE45 was founded in 1924 (preceding the UN) with a mission to “prevent animal diseases

from spreading around the world”. This international organisation has been broadening its

44 https://www.globalhealth.org/news/article/2031

45 In 2003, the International Office of Epizootics becomes the World Organisation for Animal health, but keeps its historical acronym

OIE.

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competences though bilateral agreements with other international bodies such as FAO, WHO and

CAC as well as becoming the reference for standards on animal health matters by the WTO in

1998. Indeed, since 2006 the OIE’s mission expanded to include “the improvement of animal

health all over the world”.

The organisation currently has 175 member states (or delegates) representing both,

developed and developing countries. Like the WTO, it is only accessible to the member states

however it has bilateral agreements with some stakeholders (mainly breeders’ organisations). The

organisation’s remit expands to all aspects of animal health to the point of slaughter where they

become products, and Codex takes over. They have a very good relationship with CAC, working

collaboratively in areas of overlap and similarly to the Codex, the OIE’s regulations are trade-

oriented.

The OIE governance is through the council, 5 regional commissions and 4 specialist

commissions - Terrestrial, (ensuring that the recommendations on terrestrial animals are up to

date) aquatic (same but for aquatic species), laboratories (approving methods of diagnosing

diseases) and scientific (identify measures for disease prevention). In addition, they have several

permanent working groups and create ad hoc expert groups in topics of interest (i.e. animal

cloning) to ensure that their guidelines are based on sound science.

Once the OIE decides to work on a specific topic they create an ad hoc expert working group

where they select members from very different geographic areas. “We try to have at least an

expert from each of the regions because that helps us, from the very beginning, to include these

different approaches”. Therefore, it is not surprising that Oie employee was not apprehensive

about considering the religious or cultural values linked to GM animals because they deal with

them on an ongoing basis: “if not you would have one scientist in the world that could give

guidance for the whole world”.

Unlike other international bodies that have an advisory role and do not enforce the

implementation of their guidelines, the OIE places a strong emphasis (and part of its budget) on

ensuring the implementation of their recommendations. As Oie employee explained “it’s key to

have good governance on veterinary services that you can apply the rules not only having

guidelines that nobody would apply, so OIE has a very strong action and helps evaluating

veterinary services and with agreements of World Bank…we try to help also for labs; we have a

training programme”. Indeed, there are 227 reference laboratories and collaborating centres that

are involved with the implementation of OIE’s guidelines.

The organisation had not been approached by anyone with regard to GM animals but

according to the Oie employee “I have the feeling the debate was at a higher level some years

ago“. Nevertheless, they are not reluctant about entering the GMO debate. The interviewee

considered that OIE did not take political positions: “we are standard setting organisation so we

would set standards when that is needed for what our members ask us to do and we would try to

make it based on science”. They also have a permanent working group on animal welfare which

they would naturally invite to comment should they work on GM animal guidelines. Indeed, it was

the Oie employee’s opinion that any guidance on GM animals should from the beginning take into

account a broad set of issues, including animal physiology and welfare, but also effects on the

environment. According to the Oie employee, one of the lessons to be learned from the GM plant

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debate was that all the issues should be discussed from the very beginning, especially when

dealing with risk perceptions because “once you have them out it’s very difficult to come back to a

scientific debate”.

10.5.1. OIE’S CODE AND MANUAL

The OIE has a code which is subdivided into 2 parts: Part 1, deals with horizontal and general

issues and part 2, focuses more on animal diseases. The Manual, on the other hand, has several

parts including topics on vaccines, somatic cell nuclear transfer etc. There is no special mention of

GM animals but it would most appropriately fit into the Manual.

As mentioned above, the OIE will dedicate part of its budget to ensure that the guidelines are

being implemented. They have helped in evaluating services in conjunction with the World Bank

and have organised several training packages for numerous laboratories.

11. INTERACTION BETWEEN STATES AND INTERNATIONAL ORGANISATIONS

The arguments used to embrace the “biotechnology revolution” have striking resemblance to

the green revolution arguments in that they both promise to tackle world hunger (e.g. according

to the ‘Looking behind the curtain’ report, “biotechnology in Africa hinges on averting mass

starvation and alleviating rampant poverty”),46 promote sustainable agriculture by reducing the

use of pesticides and substantial economic returns for states that invest in this technology.

Following similar stages to the green revolution, the GM technology was developed in First World

countries which invested heavily and during the earlier period had exclusive access to this

technology. This has not escaped the work of scholars who have remained sceptical of the ability

of GMOs to fulfil these promises (D Alessandrini, 2010, S Lieberman and T Gray, 2008). More than

a decade after they were first introduced, it is apparent that both pro- and anti-GMOs claims have

not materialised. Indeed, GMOs have not reduced world hunger, destroyed entire ecosystems, or

poisoned communities.

This section considers the GMO debate in the international sphere in order to provide an

overall description of the major driving forces that influence the GMO debate. First, we will look

at how the different interest groups have positioned themselves and the main areas of

international conflict related to GMOs. Second, we will compare the governance strategies of the

3 case studies to see how they have approached the challenges that GMOs have presented.

Finally, we will describe the opportunities and threats that might be associated with the global

introduction of GM animals, taking into account the international context.

46 http://www.wto.org/english/forums_e/ngo_e/posp47_nftc_looking_behind_e.pdf

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11.1. THE CONTINUING INTERNATIONAL DEBATE

Despite the polarised opinions and conflicting issues surrounding GMOs, GM crops have been

in the market for more than a decade. During this time, the scientific community has significantly

refined the techniques used and even answered several initial doubts (e.g. environmental effects

of Bt crops). Parallel to these advances, states have reshaped their regulations and thus had a

direct influence on the adoption of this technology. Indeed, the current GMO regulatory

frameworks of the 3 case studies are the result of an on-going dialogue between internal and

external pressures where each state has responded individually. For example, different policies in

response to consumers’ concerns increased the divergent approach to GMOS between the US and

the EU, the two major global players in this debate. In addition to being more accessible to

interest groups, the EC witnessed during the 90s their citizens’ hostility to GM food orchestrated

by ENGOs through an extremely successful public campaign which culminated in a de facto

moratorium on GMOs.

From the early stages, GMOs followed a path dependent on their use at global level.

Pharmaceutical applications or red biotechnology, with clear benefits to the consumer, have

remained immune to controversies. The debate surrounding them has been exclusively scientific-

driven by the technical limitations of reaching the market. Food applications on the other hand,

have divided governments depending on their needs and their citizens’ values. In addition,

agricultural practices have influenced the adoption of green biotechnology. For example, in the

US, agriculture has become increasingly industrialised and concentrated whereas in the EU,

although still industrialised, the overall surface area is smaller and fragmented (KL Kollman, 2003).

The differences become more significant when comparing developed and developing

countries. In the latter, agriculture is in hands of smallholders isolated from the industrialised

system and more reliant on saved seeds to replant the following year (GD Stone, 2001).

Therefore, governments from developing countries have to balance the benefits that GMOs could

have on their citizens with their ability to control the risks. As a result, certain developing

countries opted to remain GM free whilst others (i.e. India or China) invested heavily in this

technology (RJ Herring, 2008). Indeed, many African countries, due to their trade relationships

and strong colonial links with the EU, remained GM adverse (S Lieberman and T Gray, 2008, RJ

Herring, 2008). The best example is Zambia where the government rejected a shipment of

transgenic maize sent as food aid by USAID. The reasons behind this decision were not clear

although academic research generally maintains that the government was concerned about trade

disruption with the EU (S Lieberman and T Gray, 2008). Who employee explained that the

shipment was stopped because GMOs would be introduced to the country without the

government’s support owing to the farmer’s custom of saving seeds for the following season. Gef

employee on the other hand, thought that the situation “was very much NGO activism

permeating through to politicians who wanted to be seen to be taking a stance that was good for

their poor people”.

GMOs became the subject of increasing political tensions among different states which in turn

were exposed to a domestic debate between opponents and proponents of biotechnology bent

on influencing the government’s agenda. Activist movements and industry have become the main

players in the irreversible polarisation of the GMO debate. As Gef employee stated “there will

never be reconciliation, in the correct sense of the word, because this has become a truly

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fundamentalist issue that both sides have dug themselves in so hard and have resorted to using

mis-information and dis-information that there is no real area for bringing people together and

finding reconciliation”.

On one hand, agrochemical industry (led by Monsanto) soon embraced the GM technology

whilst investing heavily in the marketing of GM seeds. Industry has repetitively portrayed this

technology as the only solution to feed the growing human population, especially the most

deprived communities. These promises clash with the fact that after more than a decade, green

technology still focuses on traits that increase production rather than those that benefit the

consumer (RJ Herring, 2008). The aggressive industry campaigns combined with the unification of

the agricultural industry against the precautionary principle allowed opponents of GMOs to

expose industry as being solely focused on their revenues whilst ignoring the risks to health and

the environment (J Chataway et al., 2004).

Anti-GM lobbies encompass a number of interest groups with diverse goals: traditional

agriculture, the needs of the developing countries and protection of the environment. Although

they have been able to unite themselves under a single umbrella in some countries (i.e. European

states) in other states they have been unable to provide a single voice (i.e. US or India). Most of

their arguments are based on the unnaturalness of GMOs and equating scientific uncertainty with

risks to human health and the environment. In addition, the fact that the agricultural industry is

monopolised by a few multinational companies that share most of the market, helped activist’s

campaigns focusing on attacking capitalism rather than on the risks that GMOs might pose per se.

This has been extensively documented in the EU but Epa policymaker agreed that this argument

was also common in the USA. It is interesting to note that NGOs have connected with the mass lay

audiences in the developed countries whereas in developing countries (i.e. India) activists have

portrayed a romanticised vision of the farmer (and is very distant from their harsh living

conditions) specifically targeting the middle classes (R Herring, 2009).

Finally, the scientific community is also an important player. In some countries such as India

or the US, scientists have been involved in risk communication. However, the technicality and

complexity of the technology added to its inherent uncertainty has increased the distance

between scientists and lay audiences. On the other hand, the multidisciplinary nature of GMOs

has also caused disagreements among different scientific disciplines, namely molecular biology

and ecology/population biology. Overall though, there is a greater level of uniformity and

collaboration within the scientific community. As Rtd policymaker stated “whether you talk about

research or research policy, these are different issues…I think there is already a very good

collaboration… one part of the world does for sure know what the other part does”.

International organisations have remained less responsive to the different stakeholders’

agendas. This situation is to be expected since these organisations are not accountable to the

general public but to their member states. There is however, a degree of diversity in the

permeability of these bodies to interest groups. Certain international bodies are more accessible

to stakeholders (e.g. Codex, WHO, GEF) than others (e.g. WTO, OIE). This does not seem to cause

any operational problems. For example, Who employee stated that despite the different

perspectives between industry and ENGOs, the WHO succeeded in reaching an agreement on the

design of the risk assessment. The neutrality of these organisations provides a forum for

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exchanging points of view not only between individual states but also between non-governmental

actors.

The success of these international bodies according to one Oie employee is because: “the

more you go broader the less pressure might go in different directions”. This is not always the

case. For example, it is widely recognised that the World Bank has a pro-industry position. When

it was involved with setting up the National Biosafety Framework for India, it struggled (according

to the Gef employee) because it was severely attacked by NGO activists. Nevertheless, within the

highly polarised GMO debate, these international bodies have played a key role in keeping the

debate relatively open and neutral. In response to their intervention, the main areas of initial

conflict and risks to human health and environmental have been tackled quite successfully at

international level. Organisations such as the OECD, CAC and WHO/FAO have taken an active role

in developing international guidelines that harmonise the risk assessment of GMOs. Taking

advantage of the universality of science, the risk assessment stage is currently quite harmonised.

The Efsa scientist 1 explained that consumer organisations will look for differences in the results

of the assessment in different states as “everybody is using very similar methodology for food

safety…so people if they use the same methodology, they should come to the same conclusions”.

However, due to the variability of the different world biomes there has been less uniformity in the

environmental risk assessment. Who employee commented: “consumer food scares can be easy

to solve when detected whereas environment you don’t know the effects, it is impossible to

quantify”. Nevertheless, UNEP collaborated with GEF on the support of the Cartagena Protocol

and the OECD (lead by Canada) is currently working on a project entitled ‘Environmental

Considerations for Risk/Safety Assessment for the Release of Transgenic Plants’47.

No international organisation has been formally involved in the development of a particular

state’s approach to GMOs because this would interfere with their sovereignty. As Cac employee

explained “member countries have their own sovereignty. Therefore, Codex texts need to allow

flexibility for their own use”. It is also important to take into account that not all countries will be

members of the same agreements or international bodies. However, all our 3 case studies had

similar membership in all the described organisations with the exception of the Cartagena

Protocol which the US has not ratified.

Biotechnology is complex to regulate because it is strongly connected with policy domains

such as trade liberalisation, intellectual property regimes, agricultural policies, pharmaceutical

availability, among others (M Cantley, 2007). Despite the similarity of the topics debated, the

presence of different interest groups and diverse citizens’ values have triggered a range of

government policies towards GMOs placing the US and the EU at the opposite ends of the

regulatory spectrum. In addition, an issue which governments are reluctant to recognise and deal

with is the lack of internal communication among different ministries. An example of this is the

Czech Republic which cultivates GM maize and has ratified the CP. As such, Czech policymakers

will create a national biosafety committee (under the Ministry of Environment) and will deal with

management issues of GMOs such as co-existence measures (under the Ministry of Agriculture). It

was clear to Gef employee that both ministries “don’t seem to be particularly well joined up” and

47 http://www.oecd.org/dataoecd/55/25/45575159.pdf

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yet when he questioned this both ministries insisted on their good levels of collaboration. This

was also noted at an EU level by EFSA and EMA scientists, who were well aware that the national

competent authorities dealing with GMOs applications for food and pharma were never under the

same ministry and lacked internal communication. Similarly, at international level, the WTO

agreements were negotiated by the Ministries of Trade whereas the Ministries of Environment

were the sole negotiators of the Cartagena Protocol (S Zarilli, 2005). The results of these

differences appear in the texts of both agreements.

Trade, which has been sensitive to both cultural values and economic interests, has been

severely affected by the polarisation of the GMO debate. The effects can be seen at both national

and international levels. The existing regulatory variability has negatively affected the

export/import of agricultural goods and over the years there has been an increase in issues

concerning asynchronous authorisations, adventitious presence, illegal seed trade and even

labelling disagreements that have had significant effects on international trade. None of the 3

case studies had been able to avoid any of these effects on their trade.

The Cartagena Protocol (CP) is the only international agreement to address both trade and

the effects of GMOs on the environment. Unfortunately, the lack of liability and compliancy

provision reduces the potential impact of the CP (although this may change after the new

supplementary protocol is introduced). The difficulties in reconciling trade and the environment

were already discussed at the OECD which decided to create a Joint Working Party on Trade and

the Environment (JWPTE). This Working Party highlighted the tensions associated with the

protection of biodiversity in developing countries where the need to export goods in order to

boost the economy may conflict with the health, safety and environmental requirements of

biodiversity48. The WTO agreements, on the other hand, are binding documents and have a highly

effective system of dispute settlement. The objective of this organisation is the liberalisation of

trade with little involvement in GMO policy formulation. Hence the WTO dispute on US, Canada

and Argentina against the EC challenged the WTO system in terms of issues such as how risk is

defined and the assessment of the level of risk that GM food poses to the consumer and the

environment.

In the near future there will inevitably be further scientific development with consequent

regulatory challenges. Science is evolving rapidly and the next generation of GMOs will have

GMOs with multiple traits rather than single gene insertions. This will clearly challenge the

existing risk assessment of GMOs which is based on the concept of substantial equivalence

(equivalent to the traditional crop or to the GM crop with a single gene insertion?). Another

practical burden may arise in the type of comparator for the RA of the second generation (i.e.

quality traits rather than production traits) of GM crops. Furthermore, other emerging techniques

that modify the genome but do not necessarily add novel characteristics or rDNA (e.g. zinc finger

nucleases or gene shuffling) might hamper its commercialisation and/or affect the country’s

global competitiveness if governments regulated them under GMO regulation, as it has already

been proposed by certain MS in the EU49. While it is difficult to imagine the end of the polarisation



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of the debate, the international GMO landscape is expected to change significantly. Although

originally GM technology was limited to developed countries, the investment in the field by some

developing countries (e.g. India, Philippines, China) mean that the international arena will soon be

host to an increased number of national players with an array of domestic agendas. This situation

may reduce the level of polarisation that characterised the 90s debate with international

organisations gaining an even more pivotal role in harmonisation.

11.2. COMPARISON OF GMO REGULATORY FRAMEWORKS

The development of GMO governance is influenced by global forces that include international

treaties with differential state membership, domestic government agendas and the activities of

national and transnational non-governmental actors. The governments of the EU, the US and

India respond to their perceptions of their citizens’ needs. The US has taken a more relaxed

approach given the high acceptability of GM food to the American consumer of GM food. India’s

approach balances the need to provide food safety whilst minimising the risks of GMOs. The EU,

in response to the public concerns raised by the “Frankenfoods” campaigns, has developed a

regulatory framework that although in theory is in line with international standards, in practice is

the most restrictive regulatory framework in the world.

At the risk assessment stage, both India and the EU follow the Codex guidelines whereas the

US has used its existing regulations to assess the safety of the different GM products. This

however will change with GM animals where the US has also adopted the Codex standards (see

section 10.2.1). Only the US and EU have an independent scientific body although again, this will

soon change with the development of BRAI in India (see section 7.2.5). The independence of the

scientific agencies in the EU is ensured by the GMO panel within EFSA, although this arrangement

has some disadvantages such as a lack of communication between the applicant and the

assessors. The fact that EMA or even other EFSA panels maintain regular contact with the

applicants highlights the uniqueness of the GMO debate in the EU. All the other scientific bodies

were more accessible to stakeholders although both RCGM and GEAC have been criticised for

being too close to government and FDA and APHIS for being too business-friendly.

Scientists who belong to the regulatory bodies are well aware of the limitations caused by the

uncertainties surrounding GM technology but have made efforts to address them as noted by Efsa

scientist 2, “it is not a limiting factor. It is a factor you have to deal with”. In countries within the

EU and in the USA, there is a strong scientific community with organisations such as the Royal

Society in the UK and the Academy of Sciences in USA producing independent reports on GMOs.

Scientists in the EU have regular contact with EFSA/EMA and DG RTD but less so with the other

DGs. Epa policymaker confirmed that in the US scientists are not very active in defending their

position. Due to the funding strategies in India, the reduced pool of GMO experts is compensated

for by a much closer contact between the scientists and policymakers.

There was overall agreement among scientists involved in risk assessment that allergenicity

and environmental risks are the main areas of conflict. In the former this is due to the difficulty in

setting a threshold and the predictive power of tests, and in the latter because it is hard to decide

what to monitor. Ecological monitoring and field trials have proven very useful in increasing

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environmental knowledge although field trials are unpopular in the EU because of the

interventions of activist groups in destroying crops50. Interestingly, whereas GEAC and EFSA focus

on environmental risks, EPA also takes into account environmental benefits.

For pharmaceutical applications, there were no significant problems in the area of risk

assessment despite the fact that the technology for gene therapy is still very new (most of the

applications are at the clinical trial stage). This limits the ability to predict possible policy gaps. In

the US, where there have been several biotechs investing in plant biopharming, containment

measures had proven to be a major challenge51.

The difference between food and pharmaceutical applications is even more apparent in the

risk management process. For the pharmaceutical arena, the process is fully operational in all 3

case studies although within the EU, the level of decision-making is still limited. For example,

when industry asked EMA to ensure that there is a level of harmonisation on the approach taken

to recombinant medicines (either under Directive 2009/41/EC or Directive 2001/18/EC), both

interviewees (Ema scientist 1 and 2) commented that they had not the authority to do this.

With regard to GM food/feed applications, it is difficult to compare the EU, US and India at

the risk management stage. Each case has developed its particular set of policies in response to

citizens’ values and economic interests. Furthermore, unlike India and the US, the EU is a supra-

state representing the interests of 27 states. It should be noted that in response to the GMO

crisis, all the EU member states turned to the EC to develop a centralised regulatory framework.

However, because the European debate has remained highly politicised in the EU the comitology

procedure has never been well functioning. In July 2010 DG SANCO proposed to give member

states the sovereignty to decide whether they want to cultivate or ban approved GMOs. Although

there is not a clear consensus, this is seen as a move from the EC to avoid the legal exposure

which triggered the WTO dispute and to increase the operability of the regulatory process.

In the American case, the acceptability of GM food to the American consumer has facilitated

the integration of biotechnology into the agricultural industry in the US, which is currently the

major GM crop exporter. India, as with all developing countries has faced also a different set of

challenges. Despite the possible risks, the benefits attached to the GMOs are best summarised by

the quote from a Punjabi Indian farmer: “it is better to die by eating something rather than

starving” (quote translated by Rcgm policymaker). India has invested in GM technology with the

objective of alleviating their citizens’ needs – needs which are significantly different to those of

the US and EU consumers.

All 3 case studies show the influence of a variety of stakeholders on the GMO agenda and

ultimately, the regulatory framework. Industry and ENGOs have been the most important

stakeholders. The polarisation of the debate has made the two sides irreconcilable “as if you have

two people in the room who can only tolerate each other by staring at different walls” (Gef

employee). Both groups have been extremely active in lobbying although ENGOs have proved to

be more efficient in raising public awareness in their campaigns. It is interesting to note that all


51 Based on Epa policymaker rapport as I was unable to confirm this information with APHIS.

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the campaigns have focused on GM food and not recombinant medicines because of the stronger

benefits attached to the later applications. Currently in the EU, ENGOs approach DG SANCO, DG

ENV, DG AGRI and as expected, EFSA. More importantly, they have also accessed MEPs and have

organised anti-GMOs campaigns in several EU member states. In the US, ENGOs have had a

marginal activity and their campaigns have mainly focused on requesting stricter regulation to

GMOs rather than banning them. Finally, the Indian government is regularly approached by

industry, activist representatives, scientists and media.

Agricultural and biotechnology industries have also played a role in influencing the different

policy frameworks. For example, FDA tried in 2001 to enforce mandatory notification of any GM

food that entered the food chain and failed due to successful lobbying from the industry. The EC

has been accused by ENGOs of being GM-friendly because it has approved several the

applications cleared by EFSA. Furthermore, it was noted by the Who employee that the biotech

companies had in general played a significant role in influencing policy-formation in the

developing countries. Policymakers interviewed in the 3 case studies were perfectly aware of the

industry’s intentions and tried to maintain some distance from them. As Rcgm policymaker stated

“the GM people, anti-GM people, the regulators is a triangle. Now it all depends upon how strong

is the regulator and how much he is able to argue”.

Consumers’ responses have also shaped the policy outcome. An array of socio-economic

values resulting from the cultural and religious diversity of the different states has shaped the

different policy frameworks. In the case of GM plants, the European and Indian citizens hold

similar positions with concerns over the “naturalness” of GMOs and the opposition to “tampering

with Nature”. US citizens on the other hand, are not that concerned about the origins of their

food although in the case of GM animals their opinions seem to move closer to the other case

studies (more detail in the next section). Another issue is the differences between preferences of

the wealthy citizens of the developed world and the poor communities in the developing

countries. These contrasting realities are nowhere clearer than in India where the conflicts

between urban well-off citizens and poor rural communities triggered the failure of the Bt cotton

activist campaigns. In contrast, the Bt brinjal introduction has experienced a better orchestrated

resistance and despite being cleared by GEAC it was ultimately banned by the Minister of

Environment after a general public consultation. Indian policymakers clearly struggle to adjust to

both pressures (i.e. farmer’s needs with middle class consumer’s concerns) although the benefits

associated with Bt crops made them optimistic about their ability to convince their growing Indian

middle class of the need to introduce GM food crops.

The final decision on GMOs governance carried other socio-economic consequences that each

country had to handle, notably trade disruption. The US, which embraced GM technology from

the very beginning and has no traceability/segregation methods has long suffered trade

restrictions from countries such as Japan or the EU which require mandatory labelling and follow

the Codex guidelines. This opened the possibility of new niche international markets for some

states and for example, Brazil, a strong GM producer has decided to maintain a percentage of

their cultivars non-GM in order to supply the EU’s demand. Similarly, Indian food importers are

concerned about the impacts on their trade with the EU if India starts producing GM food. Geac

policymaker, recognising the consequences of GM technology, stated that they will not develop

GM basmati rice as it is an important export quality crop. Illegal trade is also a generalised

80

concern by all states and as Cac employee explained, there are different types of illegal trade. One

is illegal or the product of malicious intent which is not specific to GM. Another type is illegality

because of insufficient harmonisation in regulation, such as asynchronous authorisation among

member countries. Indeed, GM crops are currently ubiquitous and the next generation of crops

will have multiple traits rather than a single gene. This will render detection difficult and perhaps

question the concept of substantial equivalence. The EU is expected to suffer economically in the

future from their rapidly increasing backlog in authorisations. The final consideration is illegal

trade due to gaps in the implementation of regulations. For example, the Indian government has

to develop a mechanism to stop the spread of spurious Bt cotton seeds because similar issues are

likely to increase if new GM crops are introduced.

As explained above, to regulate the trade of GMOs there are currently 2 international

agreements, the Uruguay Round agreements and the Cartagena Protocol. The first is a set of

binding legal documents administered by the WTO whereas the Protocol is a multilateral

environmental agreement administered by UNEP-GEF. All 3 case studies belong to the WTO but

only India and EU ratified the Protocol. Despite not ratifying the Protocol, the USA has clearly

responded to international trade pressures as seen in the CF website: “The United States has

invested considerable time and resources into the creation of this website and database [clearing

house], and wishes to share its experience with others. By doing so, it hopes to facilitate

transparent, science-based evaluations of Living Modified Organisms52”. In this website

developing states are invited to participate in training workshop (co-funded by the UNEP-GEF and

the US government) on the use of the US template for the collection of LMO data. On the other

hand, the WTO has already proved that its highly efficient dispute settlement system is able to

address GMO-related disputes. In addition, several international organisations such as the Codex

and OECD recommend early notification of intent and adoption of international standards as

measures to minimise international trade disruptions53. Developing countries however, are

concerned with the economic effects that adopting international standards can have on their

economies as well as the fact that certain measures such as traceability might be unrealistic.

Finally, risk communication strategies are very different in the 3 case studies. Unlike India or

the EU, the USA has never experienced a GMO crisis of the European and Indian magnitude but

the government has remained active in minimising the public’s misperceptions of GMOs. This can

be seen in decisions such as changing ‘plant pesticide’ to ‘plant-incorporated-protectants’, and in

the use of ‘genetically engineered’ rather than ‘modified’ or requiring products to be labelled as

“none of the components of this product was done using GM technology” rather than “GM free”.

Nevertheless, the trust of the American consumer in their regulatory agencies has been the main

factor in maintaining the GMO debate at a scientific level.

International anti-GM activist have been very active in spreading their message and the

current amount of politicised and polarised information is considerable. As the Gef employee

noted “it’s part of a broader problem of how do we deal with the fact that there are a million new

web pages every hour (or whatever the statistic is) and how do you know which opinions are true

and which are not”. The anti-Bt cotton campaigns in India were directly nourished by the

52 http://usbiotechreg.nbii.gov/capacity.asp


81

information available on the web and in return they provided activists from developed countries

tales of poisoned goats and farmers’ deaths due to Bt cotton. On the other hand, because Indian

policymakers are accustomed to being approached by numerous stakeholders and in appearing in

the media regularly, they were not adverse to risk communication. For example, in response to

the Bt brinjal crisis, they started organising public workshops where scientists answered the

citizens’ and media queries. These meetings proved a success with some changes in the media’s

opinion already detected according to Indscientist who said “in response to the opposition we

started communicating. We had done this earlier even before the opposition came it would have

been better”.

A very different situation is seen in the EU with a clear distance between the European

citizens and Brussels. Member states and the EC have developed a highly robust regulatory

framework based on the reports produced by an independent scientific authority. Unfortunately,

the general public remains highly unaware of this system with ENGOs the only interest groups

that regularly contact them. Moreover, the level of rejection of GMOs is not uniform within EU

member states with Austria, Greece, Germany and France the biggest opponents and Spain, Czech

Republic and UK more pro-GMOs. This further complicates the development of a centralised

strategy on risk communication to European citizens.

12. GM ANIMAL REGULATION IN THE INTERNATIONAL CONTEXT

GM animals will fit within an existing system of global and national GMO governance although

it remains to be seen whether the different regulatory frameworks adopted by states will present

opportunities or threats to the success of this biotechnology and its applications. Furthermore, as

seen in the previous section, regulatory frameworks are the result of national and international

forces and it is therefore important to be able to identify the main players shaping the GM animal

agenda.

At national level it is expected that stakeholder groups already present in the GM plant

debate will use their networks and organisation to influence policy. Others, such as welfare

organisations, will be new to the debate. The influence that the different interest groups will have

on the government’s agenda is not clear. For example the breeding industry is not as optimistic

as the agricultural industry about the benefits of GM animals. ENGOs on the other hand are

expected to be involved in the debate although this time will compete for impact with animal

welfare organisations. It remains to be seen whether these groups will collaborate or will take

different positions in search for a specific niche market. Other stakeholders such as consumer

organisations, media or scientists are expected to take similar positions to those adopted in the

GM plant debate.

It seems likely that the GMO debate will soon be re-opened although this time with an extra

layer of complexity because of the strong human attachment to animals. Some states have

anticipated the voluntarily or involuntarily entrance of transgenic animals into their domestic

market and started to amend their GMO regulation to accommodate animals. From the 3 case

studies, the USA has carried out the most significant changes treating transgenic animals as “new

drugs” and regulating them under the FFDCA which requires a mandatory risk assessment that

will analyse (for the first time) the transgenic animal as a whole. Owing to its novelty, there is

82

currently very little experience on how well this legislation is appropriate to American needs,

although by adopting the Codex guidelines it is expected that there will be a reduction of the

trade barriers encountered with GM plants. In the US there are already 2 GM animals in the

market (i.e. ATryn goat and GloFish) and one close to market (AquAdvantage salmon).

In India the situation is very different because the government is just starting to see the

results of their long investment in GM technology with several GM crops moving closer to the

market. In a country where vegetables not only are an affordable food for most of the deprived

population but also, a significant amount of the population is vegetarian, not everyone would

benefit from the introduction of GM animals. The applications of GM animals would be further

complicated by the diversity of cultures coexisting within the country and the higher costs of this

technology when compared to GM plants. However, all Indian interviewees believed that GM

animals with enhanced nutritional value would be considered by the government although they

were currently waiting to see how this technology is perceived internationally.

Finally, in the EU the situation for transgenic animals is slightly different to that of GM plants.

The GMO regulatory framework is broad enough to include most of the issues that GM animals

raise including ethical and socioeconomic considerations. There is however a need for specific

guidelines which currently the EFSA’s GMO panel is working on in collaboration with the animal

welfare panel. Similarly, EMA is in the process of updating their existing guidelines on animal

bioreactors. GM animals are also expected to promote collaboration between EFSA and EMA on

issues such as animal husbandry when working with bioreactors. It remains the case, however,

that the comitology procedure in the EU is not well functioning for GMO food/feed applications.

At international level, some international bodies such as Codex and the WHO have already

developed guidelines specific to transgenic animals (including fish). The development of these

guidelines began to appear in the agenda of these organisations in the 90s when there was a

belief that GM animals would soon reach the market. Indeed, several interviewees commented

that industry had pushed for these guidelines in the 90s (especially for pharmaceutical

applications) although these were not finalised until recently. Therefore, WHO published their

guidelines in 2003 and Codex in 2008.

One of the problems with regulating GM animals at international level will be the difficulty in

harmonising the diversity of cultural/ethical values, especially with regard to certain animals (e.g.

pigs, cows), which limits the ability to reach international consensus as with GM plants.

Furthermore, another issue mentioned repeatedly by scientists assessing applications was the

long life cycles of animals. This diminishes the number of individuals available to reach statistical

significance and complicates further the risk assessment. With regard to the environmental risk

assessment, transgenic animals pose fewer risks to the environment than plants due to the lack of

horizontal gene transfer. There are however, some exceptions with highly mobile animals (e.g.

rabbits, birds, fishes). These escapees would be difficult to track down and might establish

themselves as feral communities. Another issue with certain GM animals is the existence of

sexually-compatible wild counterparts (which might even be endangered) which could trigger the

spread of the transgene into the wild population’s genetic pool. Moreover, certain species such as

salmon are top-level predators (i.e. at the end of the aquatic food chain), which complicates

further the ability to predict the consequences of escapes into the environment. As Efsa scientist

83

1 recognised “if you move a top predator into a different environment, it is extremely difficult to

predict what would happen. If you look at the past history of introductions of fish into different

environments...the risk assessments are often wrong”. Therefore, it is important to take into

account the local fauna when assessing the release of LMOs. With a liability/compliance

mechanism the Cartagena Protocol should be (in theory) able to tackle this issue at international

level.

Among the different international bodies, the OIE is expected to play a key role on GM

animals. The organisation seems well prepared for the role as it has an extensive experience in

bridging scientific facts and cultural values (it has a permanent animal welfare working group) in

addition to a strong emphasis on regulating the implementation of their guidelines. This should

ensure a certain level of harmonisation with regard to animal husbandry and health for both

pharmaceutical and food applications. However, this organisation is not planning any activity as it

has not been brought up by any of their members. This situation was also present in other

organisations where with the exception of the OECD (currently working on a consensus document

on the biology of salmon) no other international body interviewed was planning any activity on

GM animals.

With regard to international trade, the WTO agreements will probably still remain as the

international reference for food/pharma products derived from transgenic animals. Because the

OIE sets the standards on animal health under the SPS Agreements, the WTO should be able to

handle disputes regarding GM animal trade although it remains to be seen how the different

ethical and cultural values surrounding GM animals will be dealt with in such a trade-oriented

organisation.

In a very different regulatory environment, pharmaceutical applications are expected to

encounter a similar distribution of interest groups. The regulatory system is already prepared to

introduce GM animal applications and in fact, it has already been used in all the 3 case studies.

However, the policymakers interviewed were sceptical of the real possibilities of

biopharmaceuticals to reach the market. As Env policymaker stated “it is one of those things that

you always hear about but you never see coming”. Indeed, technical problems (e.g. stability of the

construct, containment, statistical power) have prevented the animal biopharming industry from

fulfilling original ambition. In addition, in the EU despite general support from all interviewees due

to the clear benefits of these applications, DG AGRI remains a strong opponent of biopharming

due to the economic risks if these animals entered the food chain. USDA has already been

involved in the mediation of several cases of cross-contamination in plant biopharming which

proved costly. In the EU one would have to add the public fear of transgenic organisms.

In conclusion, this report aimed to highlight the existing interactions among the political

actors and structures which have shaped the evolution of the market of GMOs. The different level

of interactions and different regulation strategies will surely shape the evolution of GM animals

within the existing GMO legislation. Therefore, it is important to understand the specific

governance of GM animals and the arrangement of players within each sector.

In our next activity (6.2) we will analyse the interactions among the three governance

domains (science, market and public) for the breeding and pharmaceutical sectors. This activity

will study the funding, workforce, venture capital, IPs and regulation for both the breeding and

84

the pharmaceutical sector with regard to GM animal technology in the EU. Results from the

scoping exercises produced by WP1 (public acceptance), WP2 (scientific advances), WP3

(economic feasibility of GM animals), WP4 (animal welfare, health and environmental issues), and

WP5 (ethical implications) will be compared with the existing regulatory and governance

landscape in order to identify possible policy gaps.

85

REFERENCES

Abramson, S. H., Bridges, A., Dyer, W.E., Faust, M. A., Harlander, S. K., Hefle, S.L., Munro, I. C., Rice, M. E., Martin, P., Miller, S., Pitts, K. and Smith S. A. (2001) “Evaluation of the U.S. Regulatory process for crops developed through biotechnology”. CAST Issue Paper (Number 19).

Alessandrini, D. (2010). "Gmos and the Crisis of Objectivity: Nature, Science and the Challenge of

Uncertainty." Social & Legal Studies 19(1): 3-23.

Arora, P. (2005). "Healthcare biotechnology firms in India: Evolution, structure, and growth."

Current Science 89(3): 458-463.

Bernauer, T. and E. Meins (2003). "Technological revolution meets policy and the market:

Explaining cross-national differences in agricultural biotechnology regulation." European Journal

of Political Research 42(5): 643-683.

Borras, S. (2006). "Legitimate governance of risk at the EU level? The case of genetically modified

organisms." Technological Forecasting and Social Change 73(1): 61-75.

Cantley, C. (2007) “An overview of regulatory tools and frameworks for modern biotechnology: A focus on agro-food”. OECD International Futures Programme on "The Bioeconomy of 2030: Designing a Policy Agenda"

Chataway, J., J. Tait, et al. (2004). "Understanding company R&D strategies in agro-biotechnology:

trajectories and blind spots." Research Policy 33(6-7): 1041-1057.

Fox, J. L. (2008). "FDA transgenic animal guidance finally surfaces." Nature Biotechnology 26(11):

1205-1207.

Ghosh, P. K. (2002). "India's wasteful war on biotechnology - Response." Trends in Biotechnology

20(9): 375-375.

Herring, R. J. (2008). "Science and society - Opposition to transgenic technologies: ideology,

interests and collective action frames." Nature Reviews Genetics 9(6): 458-463.

Herring, R. (2009). “Persistent narratives: Why is the “Failure of Bt cotton in India” story still with

us?” AgBioForum 12(1): 14- 22.

Losey JE, Rayor LS, Carter ME. (1999) “Transgenic pollen harms monarch larvae”. Nature. May 20;

399(6733):214.

Kesavan, P. C. and M. S. Swaminathan (2005). "Ethical, social, environmental and economic issues

in animal agriculture." Applications of Gene-Based Technologies for Improving Animal Production

and Health in Developing Countries: 447-462. 793.

Kessler, C. and Economidis, I. (2001) “A Review of Results: EC-sponsored research on safety of

genetically modified organisms”. European Directorate-General, European Comission.

Lieberman, S. and T. Gray (2008). "GMOs and the developing world: A precautionary

interpretation of biotechnology." British Journal of Politics & International Relations 10(3): 395-

411.

Mashelkar, R.A. (2005). “Report of the Task Force on Recombinant Pharma (Recommendations for Streamlining the Current Regulatory Framework)”. Ministry of Environment and Forests. Government of India.

McHughen, A. and S. Smyth (2008). "US regulatory system for genetically modified [genetically

modified organism (GMO), rDNA or transgenic] crop cultivars." Plant Biotechnology Journal 6(1):

86

2-12.

Miller, H. I. (2008). "FDA on transgenic animals--a dog's breakfast?" Nat Biotechnol 26(2): 159-

Mishra, N., P. N. Gupta, et al. (2008). "Edible vaccines: A new approach to oral immunization."

Indian Journal of Biotechnology 7(3): 283-294.

Nature Editorial (2008). "Animals aren't drugs." Nature 456(7218): 2.

Nester, E. W., Brakke, M. K., Chilton, M., Fedoroff N.V. and Kelman A. (1998) “The proposed EPA plant pesticide Rule”. CAST Issue Paper (Number 10).

NRC (National Research Council) (1989). “Field testing genetically modified organisms: Framework

for decision”. Washington, DC. National Academy Press.

Padmanaban, G. (2003). "Growth of biotechnology in India." Current Science 85(6): 712-719.

Prakash, A. and K. L. Kollman (2003). "Biopolitics in the EU and the US: A race to the bottom or

convergence to the top?" International Studies Quarterly 47(4): 617-641.

Raghuram, N. (2002). "India joins the GM club." Trends in Plant Science 7(7): 322-323.

Schmidt, C. (2006). "Belated approval of first recombinant protein from animal." Nature

Biotechnology 24(8): 877-877.

Scoones, I. (2008). "Mobilizing against GM crops in India, South Africa and Brazil." Journal of

Agrarian Change 8(2-3): 315-344.

Skogstad, G. (2003). "Legitimacy and/or policy effectiveness?: network governance and GMO

regulation in the European Union." Journal of European Public Policy 10(3): 321-338.

Spok, A. (2007). "Molecular farming on the rise - GMO regulators still walking a tightrope." Trends

in Biotechnology 25(2): 74-82.

Stewart, P. A. and A. J. Knight (2005). "Trends affecting the next generation of U. S. agricultural

biotechnology: Politics, policy, and plant-made pharmaceuticals." Technological Forecasting and

Social Change 72(5): 521-534.

Stone, G. D. (2002). "Both sides now - Fallacies in the genetic-modification wars, implications for

developing countries, and anthropological perspectives." Current Anthropology 43(4): 611-630.

Stone, G. D. (2007). "Agricultural deskilling and the spread of genetically modified cotton in

Warangal." Current Anthropology 48(1): 67-103.

Thompson, P. B., Bazer, F. W., Einsiedel, E. F. and Riley M. F. (2010) “Ethical Implications of animal biotechnology: Considerations for animal welfare decision making”. CAST Issue Paper (Number 46).

Urbanik, J. (2007). "Locating the transgenic landscape: Animal biotechnology and politics of place

in Massachusetts." Geoforum 38(6): 1205-1218.

van Asselt, M. B. A. and E. Vos (2008). "Wrestling with uncertain risks: EU regulation of GMOs and

the uncertainty paradox." Journal of Risk Research 11(1-2): 281-300.

Zarilli, S. (2004). "International trade in biotechnology products and multilateral legal

frameworks." Challenges and Risks of Genetically Engineered Organisms: 29-45 223.

87

APPENDIXES

APPENDIX 1. LIST OF INTERVIEWEES

Pseudonym Institution Region

Efsa scientist 1 GMO panel - European Food Safety Authority (European Commission)

European Union

Efsa scientist 2 GMO panel - European Food Safety Authority (European Commission)

European Union

Ema scientist 1 Committee for Advanced Therapies (CAT) - European Medicines Agency (European Commission)

European Union

Ema scientist 2 Committee for Advanced Therapies (CAT) - European Medicines Agency (European Commission)

European Union

Ema scientist 3 Biologic Working Group (CHMP) - European Medicines Agency (European Commission)

European Union

Sanco policymaker DG SANCO - European Commission European Union

Agri policymaker DG AGRI – European Commission European Union

Env policymaker DG ENV - European Commission European Union

Rtd policymaker DG RTD - European Commission European Union

Trade policymaker DG TRADE - European Commission European Union

TF co-ordinator EC- US Task Force on Biotechnology Research (DG RTD) - European Commission

European Union

Epa policymaker Biopesticides Unit - Environmental Protection Agency (EPA)

United States of America

Rcgm policymaker Review Committee for Genetic Modification (RCGM) - Department of Biotechnology

India

Geac policymaker Genetic Engineering Approval Committee (GEAC) - Ministry of Environment and Forests

India

Indscientist National Institute of Nutrition (Hyderabad) India

Who employee Department of Food Safety and Zoonoses - World Health Organisation (WHO)

International

Cac employee Codex Alimentarius Commission (CAC) International

Wto employee Agricultural Unit -World Trade Organisation (WTO)

International

Gef employee Biosafety Unit – Global Environment Facility (GEF)

International

Oie employee Scientific and Technical Department- World Organisation for Animal Health (OIE)

International

APPENDIX 2. TABLE WITH GMO REGULATIONS – EUROPEAN UNION REGULATION AIM LIFE SCIENCES SOCIAL/ETHICS COMERCIALISATION RELATED LEGISLATION OTHER COMMENTS

1. GENERAL

DIRECTIVE

2009/41/EC

To preserve, protect and improve the

environment and human health.

Contained use of genetically modified

micro-organisms during the initial R&D

stages (before commercialisation)

Organisms are classified according to risk level (Art.

4.3). Physical containment/working practices are

defined for each level. Emergency plans are drawn for

failure of containment (art. 13.1)

n.a. n.a. COMMISSION DECISION 2000/608/EC of 27 September 2000

concerning the guidance notes for risk assessment

Most countries classify the early work with animals/plants as

contained use falling under this directive. RE CT: timelines for an

authorisation according to Directive 2001/18/EC or Directive

2009/41/EC do not match to Directive 2001/20/EC.

DIRECTIVE

2001/18/EC

Deliberate release of GMOs into the

environment, experimental (partB) and

commercial (partC) purposes

Directions for ERA at Annex II.; case-by-case and

step-by-step approach

Comission's Group on Ethics

in Science and Technologies

might be consulted. MS might

also take into account ethical

considerations; public

consultation

Part C: Community, centralised

authorisation procedure; provisions for

risk management, labelling,

monitoring, post-market environmental

monitoring (PMEM), information to the

public

*COMISSION DESICION 2002/623/EC of 24 July 2002 establishing

guidance notes suppplementing Annex II. *COUNCIL DECISION

2002/813/EC of 3 October 2002 and COUNCIL DECISION

2002/812/EC of 3 October 2002 on summary information formats

(distinguishing GM plants and other GMs, providing 2 formats).

*COUNCIL DECISION 2002/811/EC of 3 October 2002 establishing

guidance notes supplementing Annex VII (monitoring plan).

*COMMISSION DECISION 2003/701/EC of 29 September 2003 on a

format to report on experimental releases for higher plants.

Divided in two parts: 1) Part C for GMOs to be placed in the EU

market (responsability of MS) and 2) Part B for all other deliberate

releases (eg field trials) with responsability to EFSA and

Competent Authorities in MS. Exclusion of medicial plants for

human use w/ GMOs provided that other legislation requires

consent prior to relaseas+ ERA+ Monitoring plan. Re CT:

timelines for an authorisation according to Directive 2001/18/EC or

Directive 2009/41/EC do not match to Directive 2001/20/EC.

REGULATION (EC)

No 65/2004

To establish a system for the

development and assignment of unique

identifiers for GMOs.

n.a. n.a. a unique identifier is required for

commercialisation

to maintain consistency with developments in international fora,

the formats for unique identifiers established by the Organisation

for Economic Cooperation and Development (OECD) is used.

REGULATION (EC)

No 1946/2003

To comply with Cartagena's Protocol with

the transboundary movements of GMOs

Exports from one country to another must be reported

for informed consent. Notifications require (info for) an

ERA (annex I & II)

n.a. Identification + traceability required Does not use the Cartagena's term LMOs but GMOs.

Community Animal

Health Policy

(CAHP)

Protect the health of all animals in the EU

kept for food, farming, sport,

companionship, entertainment and in

zoos or research (when there is a risk of

disease transmission to other

animals/humans)

To minimise the incidence of biological and chemical

risks to humans, to prevent animal health related

threats and minimise environmental impacts in support

of the EU Sustainable Development Strategy.

to assure free circulation of goods and

proportionate animal movements, and

in this way to support farming and the

rural economy.

DIRECTVE

86/609/EEC and

DIRECTIVE

2003/65/EC

Provisions for the Member States

regarding the harmonisation of the

protective procedures of vertebrate

animals used for experimental and other

scientific purposes and to avoid

distortions of competition or barriers to

trade.

The directive mentions rules for general care and

accommodation (Art.5), anaesthesia (Art.8) and if the

animals are to be killed (e.g. in food safety tests),

humane method of killing (Art.9). Art.14 requires the

proper training of the persons performing the

experiments or taking care of the animals. Annex II

gives recommendations regarding the accommodation

and care of animals.

no provisions Directive requires that facilities have to

be registered or approved, responsible

staff needs to be identified; provides

for registering and identification of the

animals to be used (Art.15 & 19).

* COMMISSION RECOMMENDATION 2007/526/EC of 18 June 2007

on guidelines for the accommodation and care of animals used for

experimental and other scientific purposes ammends Annex II and

further elaborates on the recommendations.

Not clear whether animals used in experiments to genetically

modify the animal are included in the definition, however, animals

to test effectiveness and safety of foodstuffs derived from these

GM animals are covered. No conflict with Annex IV of the

contained use Directive 2009/41/EC. The Competent Authorities

issue permits and control to compliance as well as making

publically available the number and kind of animals that have

been used .

2. FOOD/FEED

REGULATION (EC)

No 1829/2003

Regulates a common centralised

procedure for RA for cultivation of GMOs

used by food/feed. To ensure a high level

of protection of human life and health,

animal health and welfare, environment

and consumer interests in relation to

genetically modified food and feed, whilst

ensuring the effective functioning of the

internal market.

EFSA will carry out the Risk Assessment (RA) on a

case-by-case basis.

Comission's Group on Ethics

in Science and Technologies

might be consulted; public

consultation.

Centralised authorisation procedure;

provisions for risk management,

labelling, monitoring, information to the

public

* COMMISSION REGULATION (EC) No 641/2004 of 6 April 2004 on

detailed rules for the implementation of this regulation. * Guidelines

for food/feed applications consisting of or derived from plants and

micro-organisms. * Scientific Opinion on Statistical considerations

for the safety evaluation of GMOs, on request of EFSA on

approaches for the analysis of compositional, agronomic and

phenotypic data from field trials carried out for the risk assessment of

GM plants and derived foods/feeds. *EFSA Guidance Document for

the risk assessment of genetically modified plants containing stacked

transformation events.

EFSA is preparing guidelines on human health risk for food/feed

safety of GM animals. EU uses OECD concept of compartative

analysis for risk assessment (no consensus documents or

guidelines for GM animals). Samples are submited to the

Coummunity Reference Laboratories in each MS. SMEs and

research institutes are de facto excluded as costs are too high.

REGULATION (EC)

No 1830/2003

To regulate the traceability and labelling

of GMOs and food and feed products

n.a. n.a. Identification + traceability required. * Commission Recommendation 2004/787/EC on technical guidance

for sampling and detection of GMOs and material produced from

GMOs

Does not apply to medicinal products for human and veterinary

use placed on the market and authorised under Regulation (EC)

No 726/2004 (replacing Regulation (EEC) No 2309/93). Products

consisting or derived of GM animals might fit in the food/feed

category (procedures described in ISO 2859).

REGULATION (EC)

No 178/2002

To lay down the general principles and

requirements of food law, establishing the

European Food Safety Authority and

laying down procedures in matters of food

safety. Scope: food & feed safety

EFSA performs risk assessment in relation to human

health

societal and ethical factors

should be taken into account

in decision making (preamble

19)

Applies to all stages of production,

processing and distribution of food and

feed. Safety requirements, traceability,

information to consumers;

establisment of a Rapid Alert System

* Guidance on the implementation of articles 11, 12, 14, 17, 18, 19

and 20 of Regulation (EC) N 178/2002 on general food law.

Medicinal products are excluded.

DIRECTIVE

98/58/EC

Implementation of the European

Convention for the Protection of Animals

kept for Farming Purposes, approved by

Decision 78/923/EEC

Rules in annex provision for the uniform application of

the Convention and its

recommendations in the Community to

avoid distortions in conditions of

competition

Directives addressing specific animal species (laying hens, calves, pigs

and broilers) e.g. Council Directive 2008/119/EC of 18 December 2008,

laying down minimum standards for the protection of calves

No conflicting elements are found with the deliberate release

Directive 2001/18/EC.

DIRECTIVE

2002/99/EC

Animal health rules governing the

production, processing, distribution and

introduction of products of animal origin

for human consumption

Veterinary checks/certificates n.a. Common health rules in the internal

market, removing obstacles in trade;

to prevent the introduction or

spread of animal diseases

89

DIRECTIVE

2006/88/EC

Health requirements for aquaculture

animals and products thereof, and on the

prevention and control of certain animal

diseases.

Competent Authority of the Member States is to

perform offical controls on establishments, take control

measures in case of disease; surveillance plans etc.

n.a. Common rules in the internal market:

traceability, good hygiene practice,

animal health surveillance scheme;

disease notification. Introduces certain

prerequisites for placing on the market

animals and products obtained from

aquaculture production, such as an

obligation to hold an authorisation,

recording and traceability obligations

and obligations to implement good

hygiene practice, in addition to the

animal health surveillance scheme

* A Guidance document according to Council Directive 2006/88/EC

and Commission Regulation (EC) No 1251/2008 (last updated 9 March

2010) has been drafted to provide an introduction into the animal health

requirements for placing on the market, import and transit of

aquaculture animals and on the prevention and control of certain

diseases in aquatic animals.

Directive adopts the Aquatic Animal Health Code and the Manual

of Diagnostic Tests for Aquatic Animals of the OIE

Code-EFABAR

To address the issues of food safety and

public health, product quality, genetic

diversity, efficiency, environmental

impact, animal health, animal welfare,

and breeding and reproduction

technologies.

Code of Good Practice n.a. Code of Good Practice for Farm

Animal Breeding and Reproduction

Organisations

* Code of Good Veterinary Practice , * European Aquaculture Code of

Conduct , * GlobalGAP standards , * Code of Practice for Good Animal

Feeding , * Code of Conduct for Responsible Fisheries .

Standard instrument in Europe for defining and implementing best

practices in farm animal breeding. Output of the EU-funded project

Code-EFABAR on the initiative of the European Forum of Farm

Animal Breeders (EFFAB).

3. PHARMACEUTICALS

DIRECTIVE

2001/83/EC and

DIRECTIVE

2003/63/EC

Community code relating to medicinal

products for human use.

Directive 2001/83/E does not have the requirement of

ERA in an application for marketing authorisation.

However, Directive 2003/63/EC introduces the ERA

when GMOs are involved. Reference is made to the

proper GMO directive and guidance documents. Risk-

benefit balance

Ethical considerations only

concern the conduct of pre-

clinical and clinical trials on

the medicinal products for

which approval is solicited.

applicable to industrially produced

medicinal products for human use

* Directive 2004/27/EC amends Directive 2001/83/EC Applicable to industrially produced medicinal products for human

use intended to be placed on the market but medicinal products

intended for research and development trials are excluded

DIRECTIVE

2001/82/EC and

DIRECTIVE

2004/28/E

Community code relating to veterinary

medicinal products (veterinary

counterpart of Directive 2001/83/EC).

Directive 2004/28/EC introduces the ERA when GMOs

are involved for veterinary practices. Risk-benefit

balance






applicable to veterinary medicinal

products

REGULATION (EC)

N 726/2004

To lay down Community procedures for

the authorisation, supervision and

pharmacovigilance of medicinal products

for human and veterinary use, and to

establish a European Medicines Agency

The positive therapeutic effects of the medicinal

product are evaluated in relation to the risks of its use

as regards the patient‟s or public health and the

environment. The approval is based upon a risk-benefit

assessment and requires demonstration of safety,

quality and efficacy. ERA is required when GMOs are

involved






The Regulation stresses on post

marketing monitoring

(pharmacovigilance) to be able to

interfere in case of adverse effects as

soon as possible.

All biotech-derived medicinal products are regulated under the

centralized procedure, managed by EMA (formerly EMEA).

Approval is then valid in all MSs.

DIRECTIVE

2003/94/EC

Description of principles and guidelines of

good manufacturing practice in respect of

medicinal products for human use and

investigational medicinal products for

human use.

n.a. guidelines for commercial productions * Rules Governing Medicinal Products in the European Union,

Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal

Products for Human and Veterinary Use (14 February 2008) contains

guidance for the interpretation of this directive. Annex 2 specifically

addresses biological products: “Manufacture of biological products for

human use ”. Cross-reference is made to Directive 86/609/EEC,

amended by Directive 2003/65/EC concerning the general

requirements for animal quarters, care and quarantine.

Address primarily the human health as employee, patient or the

general public (product quality and safety).

DIRECTIVE

91/412/EEC

To lay down the principles and guidelines

of good manufacturing practice for

veterinary medicinal products.

n.a. guidelines for commercial productions * Rules Governing Medicinal Products in the European Union,

Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal

Products for Human and Veterinary Use (14 February 2008) contains

guidance for the interpretation of this directive. Annex 5 specifically

addresses biological products: “Manufacture of Immunological

veterinary medicinal products ”. Cross-reference is made to the GMO

Directives for contained use and deliberate release as far as the

premises are concerned.

Address primarily the human health as employee, patient or the

general public (product quality and safety).

4. INTELLECTUAL PROPERTY

DIRECTIVE

98/44/EC

on the legal protection of biotechnological

inventions; to clarify the distinction

between what is patentable and what is

not;

n.a. The Commission's European

Group on Ethics in Science

and New Technologies is to

evaluate all ethical aspects of

biotechnology

n.a. Commission Report COM(202) 545 and COM(2005) 312 the main provisions of Directive 98/44/EC have been incorporated

into the Implementing Regulations to the European Patent

Convention

4. ENVIRONMENTAL LIABILITY

DIRECTIVE

2004/35/EC

establishes a framework of environmental

liability based on the „polluter-pays'

principle, to prevent and remedy

environmental damage

Annex I to determine the significance of any damage

that has adverse effects

n.a. related to PMEM Council Directive 79/409/EEC of 2 April 1979 on the conservation of

wild birds; Council Directive 92/43/EEC of 21 May 1992 on the

conservation of natural habitats and of wild fauna and flora; Directive

2000/60/EC of the European Parliament and of the Council of 23

October 2000 establishing a framework for Community action in the

field of water policy

90

APPENDIX 3. TABLE WITH GMO REGULATIONS – UNITED STATES OF AMERICA

REGULATION AIM LIFE SCIENCES SOCIAL/ETHICS COMERCIALISATION RELATED LEGISLATION OTHER COMMENTS

1. GENERAL

National

Environmental

Policy Act

(NEPA)

To preserve, protect and improve

the environment; requires federal

agencies to integrate

environmental values into their

decision making processes by

considering the environmental

impacts of their proposed actions

and reasonable alternatives to

those actions.

requires to identify risks associated with

release into the environment (Environmental

Assessment, EA) and its environmental

impact (Environmental Impact Statement,

EIS). The outcome of the EA determines

whether a full EIS is necessary. A

comparison is made with alternatives. EIS

considers benefit-risk balance

draft EA and EIS are

open for public comment

applicable to developmental as

well as commercial activitiesGuidelines for Ecological Risk Assessment

applicaple to Animal and Plant Health Inspection

Service of the U.S. Department of Agriculture (APHIS-

USDA), Food and Drug Administration (FDA),

Environmental Protection Agency (ESA), Occupational

Safety and Health Administration (OSHA) and

National Institutes of Health (NIH)

Endangered

Species Act

(ESA)

To conserve the ecosystem upon

which endangered and threatened

species depend

requires to assess whether a proposed

action harms a listed species and/or its

habitat

n.a.applicable to developmental as

well as commercial activities

CA: U.S Fish and Wildlife Service (FWS) or the

National Marine Fisheries Service (NMFS); Atlantic

salmon is listed in Maine

Fish & Wildlife

Coordination Act

(FWCA)

to protect fish and wildlife when

federal actions result in the control

or modification of a natural stream

or body of water.

requires to assess whether a proposed

action (modification of a water body) harms a

listed species and/or its habitat



CA: U.S Fish and Wildlife Service (FWS) or the

National Marine Fisheries Service (NMFS); relevant

for aquaculture with GE fish

Clean Water Act

(CWA)To protect surface water quality assessment of the effect of waste water n.a.


well as commercial activitiesCA: EPA

Animal Health

Protection Act

(AHPA)

To protect the health of the U.S.

livestock population. It governs

the prevention, detection, control,

and eradication of diseases and

pests of animals.

assessment of animal disease risk n.a.applicable to developmental as

well as commercial activitiesCA: APHIS-USDA, Veterinary Service

Animal

Quarantine Laws

Controls interstate movement of

potentially diseased or parasitized

animals; also deals with health

certificates for live imports and

exports.

assessment of animal disease risk

(dissemination, introduction)n.a.



CA: APHIS-USDA; Because a "biological product"

(=insert) may be a component of an infectious agent,

APHIS has to ensure that the animal bearing the

"biological product" does not pose a risk of infectious

disease.

Animal Welfare

Act (AWA)

To provide minimum standards of

care and treatment for certain

animals (warm blooded) bred for

commercial sale, used in

research, transported

commercially, or exhibited to the

public. Excluded are: birds, mice

of the genus Mus, and rats of the

genus Rattus bred for use in

research, farm animals or farm

animals used in agricultural

research.

assessment of the conditions and general

practices to keep GE animals (animal

husbandry); to comply with standards of

humane care and treatment of animals.

humane care; the Act is

to protect certain

animals from inhumane

treatment and neglect.



The Guide for the Care and Use of Laboratory Animal

(Public Health Service Policy on the Humane Care and

Use of Laboratory Animals)(NIH); Guide For the Care and

Use of Agricultural Animals in Research and Teaching

(Federation of Animal Science Societies)

CA: APHIS-USDA

Non-Indigenous

Aquatic

Nuisance

Prevention and

Control Act

To prevent and control

infestations of the coastal inland

waters of the

United States by the zebra mussel

and other nonindigenous aquatic

nuisance species

assessment the effect of e.g. escape of GE

fish from net pensn.a.


well as commercial activitiesCA: FWS

NIH’s Guidelines

for Research

Involving

Recombinant

DNA Molecules

detail safety practices and

containment procedures for basic

and clinical research involving

recombinant DNA, including the

creation and use of organisms

and viruses containing

recombinant DNA (contained use

of GMOs)

addresses the potential public health and

environmental risksn.a. n.a.

CA: NIH, guidelines are legally applicable only to NIH-

sponsored research, voluntary for others.

Establishment of Institutional Biosafety Committees to

provide local review and oversight of nearly all forms

of research utilizing recombinant DNA

Performance

Standards for

Safely

Conducting

Research with

Genetically

Modified Fish

and Shellfish

Set standards for research; to aid

researchers and institutiions in

assessing the ecological and

evolutionary safety of research

activities involving GE fish,

crustaceans or molluscs.

aids researchers in developing appropriate

risk management measures so that research

can be conducted without adverse effects on

natural aquatic ecosystems.

n.a. n.a.

developed by the Agricultural Biotechnology Research

Advisory Committee, issued by USDA: voluntary

guidelines

Occupational

Safety and

Health Act

to protecting the safety and health

of employees

Maintain conditions or adopt practices

reasonably necessary and appropriate to

protect workers on the job


well as commercial activitiesCA: OSHA

91

2. FOOD/FEED

Federal Food,

Drug, and

Cosmetics Act

(FFDCA)

To protect the public health by

ensuring that foods are safe,

wholesome, sanitary and properly

labelled. Covers all imported and

domestic food except for meat and

poultry.

The market is protected by prohibiting

adulteration and misbranding. GE animals

are assessed for environmental effects that

directly or indirectly affect the health of

humans or animals under the New Animal

Drug procedure (assessment of the genetic

construct, but also the effects due to its

insertion and expression)

Summary of a New

Animal Drug Application

is open to the public



Guidance for Industry #187: Regulation of Genetically

Engineered Animals Containing Heritable Recombinant

DNA Constructs

CA: FDA, Center for Veterinary Medicine (CVM)

Federal Meat

Inspection Act

(FMIA)

To inspect meat products for

human use for safety (before and

after slaughtering, animal

products, labelling etc.)

to prevent adulterated or misbranded

livestock and products from being sold as

food, and to ensure that meat and meat

products (as well as poultry) are slaughtered

and processed under sanitary conditions.

n.a.

applicable to commercial

activities (including products

from experiments to enter the

food chain)

Policies: Final Policy Statement for Research and

Regulation of Biotechnology Processes and Products.

Livestock and Poultry Connected with Biotechnology

Research. Update on Livestock and Poultry Connected

With Biotechnology Research.

CA: Food Safety and Inspection Service (FSIS) of

USDA, delivers approval for slaughter of GE animals

for food use (FDA food use approval needed); The

Food and Drug Administration (FDA) is responsible for

all meats not listed in the FMIA

Poultry and

Poultry Products

Inspection Act

(PPIA)

To inspect poultry products for

human use for safety (before and

after slaughtering, animal

products, labelling etc.)

to prevent adulterated or misbranded poultry

and products from being sold as food, and to

ensure that poultry and poultry products are

slaughtered and processed under sanitary

conditions.

n.a.


activities (including products

from experiments to enter the

food chain)

Policies: Final Policy Statement for Research and

Regulation of Biotechnology Processes and Products.

Livestock and Poultry Connected with Biotechnology

Research. Update on Livestock and Poultry Connected

With Biotechnology Research.

CA: Food Safety and Inspection Service (FSIS) of

USDA, delivers approval for slaughter of GE animals

for food use (FDA food use approval needed)

Federal

Insecticide,

Fungicide and

Rodenticide Act

(FIFRA)

deals with pesticides, their

manufacturing, import, sale and

use and requires that all

pesticides distributed in the U.S.

are registered with EPA; to protect

applicators, consumers and the

environment

Registration of a pesticide is only done after

a period of data collection to determine the

effectiveness for its intended use,

appropriate dosage, and hazards of the

particular material; the use of the pesticide

should not cause „unreasonable adverse

effects on the environment‟ and it also

considers the dietary risk (residues from

pesticides on food)

n.a.applicable to commercial

activities

CA: EPA; about antimicrobials, biopesticides and

traditional pesticides

Food Quality

Protection Act

(FQPA)

amends FIFRA and FFDCA;

include stricter safety standards,

especially for infants and children,

and a complete reassessment of

all existing pesticide tolerances

establishment of a single, health-based

standard for setting pesticide residue

tolerances (aggregate exposure, combined

risks)


activitiesCA: EPA

Toxic

Substances

Control Act

(TSCA)

pesticides, drugs, food, food

additives etc. that may present an

unreasonable risk to humans and

the environment.

assessment of the risk to human health or

the environmentn.a.


activities

CA: EPA; manufacturers must submit

premanufacturing notification to EPA prior to

manufacturing (or importing) new chemicals for

commercial purposes. Exceptions, including one for

research and development, and for substances

regulated under other statutes such as FFDCA and

FIFRA.

3. PHARMACEUTICALS

Federal Food,

Drug, and

Cosmetics Act

(FFDCA)

to oversee the safety of food,

drugs, and cosmetics

Assessment of both the "New Animal drug"

(=insert in the GE animal) and the

pharmaceutical that is produced

Summary of a New

Animal Drug Application

is open to the public



Guidelines: Points to Consider in the Production and

Testing of New Drugs and Biologics Produced by

Recombinant DNA technology. Manufacture and Testing

of Therapeutic Products for Human Use Derived from

Transgenic Animals.

CA: Center for Veterinary Medicine (CVM) of FDA

Virus-Serum-

Toxin Act

(VSTA)

licences the importation,

manufacturing (including the

facilities) and selling of viruses,

serums, toxins and other

analogous products used to treat

domestic animals.

examination of the product for purity, safety,

potency and efficacy.n.a.


activities

CA: Center for Veterinary Biologics (CVB) of APHIS-

USDA; regulates the biological product (=insert that

makes the animal resistant to a disease), not the GE

animal; slaughter approval for food use by FSIS; food

use by FDA

Public Health

Service Act

(PHS Act)

to ensure the product is safe,

pure, and potent and that the

facility and animals in which it is

manufactured meets standards

designed to ensure its continued

safety, purity, and potency.

the manufacturer must submit detailed

information concerning manufacturing

methods and processes (development, use,

maintenance, and eventual disposition of the

GE animal).


activities

Guidelines: The Guidance for Industry for the Submission

of Chemistry, Manufacturing, and Controls Information for

a Therapeutic Recombinant DNA-Derived Product or a

Monoclonal Antibody product for In Vivo Use.

CA: Center for Biologics Evaluation and Research

(CBER) of FDA


American

Inventors

Protection Act

(AIPA)

to protect inventions in general n.a.

Ethical questions are

addressed in other fora

(e.g. AWA)

n.a. The Utility Guidelines (USPTO)


Comprehensive

Environmental

Response,

Compensation

and Liability Act

(CERCLA)

provides for clean-up of

uncontrolled hazardous waste,

the costs of which are at charge

of waste generators, transporters,

processors, land owners

n.a. n.a.applicable to developmental

as well as commercial activities

92

APPENDIX 4. TABLE WITH GMO REGULATIONS – INDIA

REGULATION AIM LIFE SCIENCES SOCIAL/ETHICS COMERCIALISATION RELATED LEGISLATION OTHER COMMENTS

1. GENERAL

Environment

Protection Act of

1986

to protect and improve the

environment and to prevent hazards

to human beings, other living

creatures, plants and property.

The Act and its Rules lay down standards, restrict

areas for industry, develop procedures to prevent

accidents, to handle hazardous substances, inspect

facilities, prepares manuals, codes and guides,

perform research, etc.

n.a.applicable to research and

commercial activities

Environment Protection Rules, 1986, dealing

with emission or discharge of environmental

pollutants by „industry, processes and

operations‟

The Biological

Diversity Act,

2002

to provide for conservation of

biological diversity, sustainable use of

its components and fair and equitable

sharing of the benefits arising out of

the use. Establishment of National

Biodiversity Authority.

to assess the environmental impact, and to regulate,

manage or control the risks associated with the use

and release of living modified organisms resulting

from biotechnology likely to have adverse impact on

the conservation and sustainable use of biological

diversity and human health.



Act followed from India being a party to the United

Nations Convention on Biological Diversity

Rules for the

Manufacture/Use

/Import/Export

and Storage of

Hazardous

Microorganisms,

Genetically

Engineered

Organisms or

Cells, 1989.

The aim is to protect the environment,

nature and health. The Rules cover

the areas of research as well as large

scale applications of GMOs and

products made therefrom throughout

India.

Competent authorities advise, issue permits,

monitor for compliance .n.a.

Authorisation by the MoEF, advice by

GEAC

Gazette Notification No. GSR 616(E)

(4/10/2006) exempting certain categories of

recombinant pharma from the purview of

Rules,1989 ; Gazette Notification No. S.O.

1519(E) (23/08/2007) exempting GM food

stuffs, ingredients in foodstuffs and additives

from the purview of Rules,1989

Recombinant

DNA safety

guidelines, 1990

To protect the environent and human

health. The guidelines cover areas of

research involving GMOs, including

genetic transformation of green

plants, rDNA technology in vaccine

development and on large scale

production and deliberate/ accidental

release of organisms, plants, animals

and products derived by rDNA

technology into the environment.

Human cells and embryos are

excluded from the scope of the

guidelines.

Activities are classified according to organism type /

risk level . Physical containment/working practices

are defined for each level. Emergency plans are

drawn for failure of containment. Directions for risks

assessments are provided.

humane care for

animals required to

avoid unnecessary

pain or suffering

n.a.facilities need to be authorised by the Ministry of

Environment and Forests

2. FOOD/FEED

Food Safety and

Standards Act,

2006

To establish the Food Safety and

Standards Authority for laying down

science based standards for food

articles and to regulate their

manufacture, storage, distribution,

sale and import to ensure the

availability of safe and wholesome

food for human consumption.

Food Safety and Standards Authority issues

guidelines for the development of risk assessment

methodologies, undertakes risk assessments and

advises on risk management

voluntary

management

system, the Code of

Ethics, through

principles of GMPs

and the HACCP

applicable to commercial activities;

food requires accurate labelling

replaces the Prevention of Food Adulteration

Act & Rules and sections relating to food

under the Environmental (Protection) Act,

1986 and the Environment Protection Rules,

1989 and others. Regulations under this Act

are the Milk and Milk products regulations,

1992,

relies on the Codex Alimentarius; the Central Advisory

Committee advises the Food Authority; also Scientific

Panels of experts and Scientific Committees are

established; food businesses need a license; the food

safety officer inspects food and premises; import is

under the provisions of the Foreign Trade Act, 1992

and the Customs Act, 1962;

Foreign Trade

Act, 1992 and

amendments

to provide for the development and

regulation of foreign trade by

facilitating imports into, and

augmenting exports from India

import of GMOs/LMOs for food or other commercial

activities requires license by GEAC; if for R&D

license by RCGM

n.a. labelling requirement

3. ANIMALS

The Prevention

of Cruelty to

Animals Act,

1960

to ensure the well-being of animals

and to prevent unnecessary pain or

suffering; Establishment of Animal

Welfare Board of India and the

Committee for Control and

Supervision of Experiments on

Animals

Animal Welfare Board of India and the Committee

for Control and Supervision of Experiments on

Animals issue guidelines for humane treatment of

animals


commercial activitiesseveral Rules

The Breeding of

and Experiments

on Animals

Rules

to ensure that animals are not

subjected to unnecessary pain or

suffering before, during or after the

performance of experiments on them

registration of breeders and establishments where

experiments are performed: review of animal

housing, care giving, anesthesia and euthanasia;

inspection

Institutional Animals

Ethics Committees

review experiments

on animals

applicable to research and


registration of breeders and establishments where

experiments are performed

The Prevention

of Cruelty to

Animals

(Registration of

Cattle Premises)

Rules

to promote the well-being of cattleregistration of facilities for cattle; requirements for

animal housing and inspectionn.a.



registration of facilities with more than 5 cattle in cities

or towns which have a population exceeding one lakh.

93

4. PHARMACEUTICALS

Drugs and

Cosmetic Rule

(8th

Amendment),

1988

Adds a Part XA to schedule X -

Import or manufacture of new drug

for clinical trials or marketing - to the Drugs and Cosmetics Rules,

1945

122A. Application for permission to import

new Drug; 122B. and 122C. Application for

approval to manufacture New Drug

Ethical considerations

only concern the

conduct of pre-clinical and clinical trials on the

medicinal products for

which approval is

solicited.

applicable to drugs for human

and animal use

Guidelines for generating preclinical and clinical data for

rDNA vaccines, diagnostics and other biologicals, 1999;

Guidelines for Clinical Trials on Pharmaceutical Products in India - GCP Guidelines

about data requirements for license applications

Drugs and

Cosmetics (IInd

Amendment)

Rules, 2005.

Schedule Y - requirements and

guidelines for permission to import

and/or manufacture of new drugs for sale or undertake clinical trials

n.a.

Ethical considerations

only concern the

conduct of clinical trials on the medicinal

products for which

approval is solicited

(approval needed from

the institutional ethics comittee(s)).

Import and manufacture

Good

Manufacturing

Practices and

Requirements of

Premises, Plant and Equipment

for

Pharmaceutical

Products

Schedule M - requirements and

guidelines for manufacturing and

premises

n.a. n.a. applicable


The Patents Act

1970 and

amendments

on the legal protection of

inventions; to clarify the distinction

between what is patentable and what is not;

n.a.

An invention the primary

or intended use or

commercial exploitation of which could be

contrary to public order

or morality or which

causes serious

prejudice to human, animal or plant life or

health or to the

environment is not

patentable.

n.a.Patents Rules, 2003 and amendments to implement the

provisions of the Patent Act.in accordance with TRIPS


Environment

Protection Act of

1986

Section 16: any offence committed

under the Act shall be punishedn.a. n.a.



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