Essentials about the European Union
The European Union (EU, sometimes also called EC – European Communities) is a supranational body currently comprising 15 individual and sovereign Member States. This “club” of countries has decided to co-ordinate wide areas of their policies with each other, and in particular to maintain a single market - often referred to as the European Common Market. In order to do so, they have signed international treaties between themselves; currently in place is the Treaty of Amsterdam (which replaced the Treaty of Maastricht in 1998), also referred to as “the Treaty”. (A new Treaty is being negotiated between the Member States and expected to be finalised by the end of the year 2000.)
All EU legislation is created through approval by the Governments of the Member States (The European Council of Ministers, also referred to as The Council) and the directly elected European Parliament (EP). EU law overrides national laws; only where there is no EU legislation do national laws apply. The European Commission oversees the implementation of EU law and in certain areas also has an administrative role. The Commission works somewhat like a European government, with a President at its head and 20 Commissioners, each holding specific portfolios.
There are two forms of EU legislation: Directives and Regulations:
“Directives” are framework laws, which normally give minimum or maximum standards; they only give “directions”. Each Member State is required to transform an EU directive into national law, usually within 2 years. Within the framework of a directive, each Member State is free as to how exactly the national law looks like, but it must not hamper the functioning of the single market.
A directive can be distinguished by the numbering: first comes the year in which it was passed at EU level, then the respective number; e.g. “deliberate release” Directive 90/220/EC.
“Regulations” are EU laws that directly apply in all Member States from the moment that they are adopted. They become national law word-for-word, immediately and automatically, without the national parliament’s involvement.
Their numbering is the reverse from that of a directive: first the number, then the year; e.g. Novel Food Regulation 258/97/EC.
Green and White Papers
In important political questions the Commission can publish so-called Green or White Papers, in which it outlines its policy and recommends actions to be taken to address a certain area. First, Green Papers invite the public (including the European Parliament) for comments, which are then more or less incorporated into the White Paper, which outlines the Commission’s position on the issues discussed.
In 1999 the Commission published its White Paper on Food Security; in 2000 it published a long awaited White Paper on Environmental Liability, which includes references to GMOs.
Law-making process
Because of the special nature of the EU, the law-making process is very complicated and lengthy. The European Commission is the only one, of the three EU-bodies, that has the right to propose a new directive or regulation. This draft then goes to the European Parliament and the Council of Ministers for adoption. In the field of agricultural biotechnology, the focus of this report, most legislation needs the approval of both the EP and the Council (i.e. the Governments of all Member States) in order to be adopted (“Co-decision Procedure”). It often takes many years for the two bodies to agree on a common text and to adopt it. Once a directive is adopted on the EU level, it then takes another year or two to be transformed into national law. So, from the time of a published Commission proposal for a new directive, it can easily take 4 - 5 years before the directive actually becomes effective.
There are some separate pieces of legislation, like Commission Decisions/Regulations, which the Commission can adopt on its own, and Council Regulations/Directives, which are adopted only by the Council upon a proposal by the Commission. These laws take a much shorter time to be passed.
Internal market
One of the main principles of the EU is that it is an internal market with no borders between Member States. This means any product sold in one country can also be sold anywhere else in the EU (the principle of “free movement of goods”, as enshrined in the Treaty).
The Elements of a Model National Law on Biosafety
This draft document has been prepared by Third World Network to provide the governments of the South with a legislative tool to protect themselves against the import of GE seeds, crops and food. The countries of Central and Eastern Europe, including Bulgaria, are in the same weak position and faced with similar threats to those in the South.
Introduction
Nations of the South are increasingly faced with the prospect of the introduction into their countries of genetically modified organisms (GMOs) as, or in, products. These will enter countries of the Third World in greater abundance as the movement by consumers, manufacturers and retailers in the North to reject these GMOs and products gains momentum. It is now widely acknowledged that serious potential risks are presented by this technology. This prompted the international community to commence negotiations for a biosafety protocol under the Convention on Biological Diversity. But these negotiations have been stalemated. Consequently, there are no regulations in place to deal especially with the movement across boundaries of these GMOs and their products. Also, there are several aspects that need to be addressed exclusively by national laws.
This model law has been drafted to present one possible option.
The scheme of the law
1. Authorization needed for all activities and for all GMOs and derived products
The scheme of the law is to subject every activity in relation to GMOs to the regulatory control of the State. There must be formal authorisation before the GMO can be imported, introduced into the environment, placed on the market, or used in contained conditions. Without such an authorisation, the activity is illegal and penalties apply.
2. All GMOs covered
All GMOs, as well as products made from GMOs, come within the law. This would cover genetically modified fruits and plants, seeds, commodities, such as soya bean, maize and corn whether for human or animal consumption, fruits modified to be vaccines for humans or animals, transgenic fish, any organism intended for production of food enzymes, or pharmaceuticals, or imported for sewage treatment, propagating material for breeding purposes/green house cultivation, and products from transgenics, such as flour from transgenic corn.
3. Application must be made with complete information
There has therefore to be an application for approval. This has to be accompanied by very comprehensive information supplied by the applicant to allow for an adequate evaluation of any foreseeable risks from allowing the activity in relation to the GMO or derived products.
4. Risk Assessment essential
Before approval is given, there has to be a risk assessment by an independent body of experts chosen from a wide range of disciplines. The risk assessment is comprehensive, on a case by case basis, and intended to deal with all the potential risks to the environment and animal and human health. The risk assessment is based on the precautionary principle, that is, the absence of scientific evidence or certainty does not preclude the decision makers from denying approval of the introduction of the GMO or derived products if this may cause, or have a proven or theoretical potential to cause harm to biodiversity, ecosystems, or human, plant or animal health.
5. Other factors essential
Factors in addition to risk assessment must also be taken into account before authorization is given. Thus there must a cost benefit assessment of the introduction of the GMO or derived product as well as an assessment of its contribution to sustainable development. Any adverse socio-economic effects must also be considered.
6. Firm evidence of no risk essential; precautionary principle applied as well.
No authorization may be given unless there is firm evidence that there are no risks posed to the environment and human and animal health.
This is a very stringent requirement. As a fall back position the decision can be based on the precautionary principle as set out in paragraph 4 above.
7. Approval with or without conditions
When approval is given, it may be with or without any conditions.
8. Step-by-step approval
Any approval given is on a step by step basis. That is, it progresses from activity that is contained, then to trials that are in the open before fully-fledged release is authorised. At each stage, the risks are monitored.
9. Approval may be revoked
Any approval given shall be revoked if new evidence, or a review of existing information, shows potential risks based on the precautionary principle. Alternatively, fresh or additional conditions may be imposed. There is an obligation on the applicant to provide information of any possible risks that become known to him at any time.
10. Public consultation
The public must be given adequate notice of any application. They should also be given all information supplied by the applicant to the national competent authority. Public consultation should precede the making of a decision. Sufficient time before a decision is reached should be given to the public to allow for such consultation. Comments given by the public must be taken into account in the decision-making.
11. Risk management measures
After the approval, and at all times generally, the State may take measures to manage any risks posed by GMOs and derived products. These include: subjecting the activity to adequate periods of monitoring (e.g. commensurate with its life-cycle or generational time) before its allowed to be released, prohibiting any product (example, those that contain antibiotic resistance markers), ordering the cessation of any activity so that measures may be taken to prevent or limit harm, and taking emergency measures.
12. Identification and labelling
All GMOs must be identified in a particular manner; and derived products are required to be labelled in a prescribed manner. Further, the label must forewarn of any allergy that the GMO or derived product may cause.
13. No confidentiality of business in some situations
No confidentiality of business information can be claimed for information that is required for evaluation of foreseeable risks; nor can any information be with-held which will impede the State in its monitoring, supervision or enforcement work.
14. No export without prior informed consent
There can be no export of GMOs or derived products unless the State is satisfied that the country of import gives its prior informed consent.
15. Liability
The liability provisions impose strict liability for any damage caused by the introduction of the GMO or derived products. Liability attaches to any person or entity responsible for the harm. If there is more than one person responsible, then liability is joint and several. Liability extends to environmental damage caused/ the person or entity responsible must bear the costs for the clean-up and consequential damage.
16. Punishable conduct and penalties
There is a section in the law that identifies conduct that is illegal and punishable. This includes: carrying out any activity without any approval; or in violation of conditions imposed; or false, misleading or deceptive labelling; or exports without the prior informed consent of the importing country; or sells any GMOs or derived products without approval. Punishment includes imprisonment and this can be imposed on the responsible officer of a corporation as well.
17. Institutional arrangements
The law also provides for institutional arrangements: the Ministry (and the Minister) who is to be in charge, the designation of the competent authority, the functions of this authority, and the appointment of the independent body of experts.
18. Regulations
The Minister is given power to make regulations for the effective implementation of the law.
19. Transitional provisions
There is also a transitional provision. It subjects the introduction into the country of GMOs or derived products prior to the coming into force of the law to the same procedure and requirement for approval.
