V. PROVIDING FOR SAFETY: MECHANISMS AT INTERNATIONAL LEVEL USING INFORMATION SUPPLY AND EXCHANGE

40. Countries would need to establish or designate focal points responsible for the international exchange of information. This might be the authorities responsible for oversight. Countries are encouraged to cooperate with existing international agencies, organizations, mechanisms and regional networks (see Annex 6) for the dissemination of biosafety-related information. Countries and organizations should agree to protect confidential commercial information. The content of such information, however, needs to be discussed between the specific country and company or organization in order that the country can make a decision.

Exchange of general information

41. Countries are encouraged to participate in the exchange of general information about national biosafety mechanisms; generic research of value to risk assessments and risk management; and approvals given for the marketing of products containing or consisting of organisms with novel traits. This last category of information will be of particular importance for living products of modern biotechnology placed on the international market. Countries, organizations and companies will wish to be aware of which countries have adopted measures similar to those set down in these Guidelines to facilitate the exchange of mutually acceptable data and assessments. This form of information exchange can be carried out through direct information exchange, as well as through the creation of an international register or database.

Supply of information when the use of organisms with novel traits could affect human health in, or the environment of, another country

42. The use of an organism with novel trait(s) might in some cases affect other countries. For organisms representing a possible impact or threat due to transboundary movements, the following two points should be followed:

• The potentially affected country should be given notice of the intended use and the opportunity to state whether particular measures will be needed to protect its interests, in particular its biodiversity;
• The potentially affected country should be informed immediately in the event of an adverse effect of the use of a organism with novel traits which could affect it.

43. The information supplied would include the identity, the relevant characteristics and numbers/volumes of the organisms with novel traits involved and any available information regarding the handling of the organisms and information related to risk assessment and risk management.

Supply of information related to transboundary transfer of organisms with novel traits

44. Organisms with novel traits have been and will be transferred from one country to another for research and development purposes and for placing on the market. A person or organization intending to transfer organisms with novel traits to a country will need to comply with the safety mechanisms in that country. However, it is recognized that not all countries are at present able to implement safety mechanisms fully. For such countries, the following paragraphs offer a scheme for information exchange involving a range of mechanisms, from the provision of information from one user to another, to "advance informed agreement" for certain cases. They are aimed at those countries in order to enable them to achieve safety in biotechnology and to make informed decisions.

45. The key to this scheme is that, depending on the characteristics of the organism with novel traits and of the intended use, a user intending to transfer such organisms from one country to another must provide relevant information to the user or appropriate focal point(s) in the receiving country. This request for information transfer would still apply even if the organism has been exempted from oversight in the supplying country. Information could, in some cases, be supplied together with the transferred organisms with novel traits and, in other cases, in advance of the transfer (see paragraph 46 below). The provision of information prior to transfer involves a mechanism of "advance informed agreement", i.e. the transfer of organisms with novel traits to another country first requires the agreement of the receiving country.

46. Under this scheme, whether the relevant information would have to be supplied with, or in advance of, the transfer of organisms with novel traits depends on the intended subsequent use of these organisms, as follows:

• The provision of information to the intended user together with the transfer of organisms with novel traits would be appropriate in cases when such organisms are to be used in containment (e.g. research and development or storage in collections). In general, the information provided should be sufficient to enable the receiving country to undertake a risk assessment. In the case of transfer only for subsequent storage in collections, the identity and possible hazards of the organism with the novel traits would suffice, together with relevant information on appropriate storage procedures.
• The provision of information to the focal point in the receiving country before the transfer of the organisms with novel traits and under advance informed agreement would be appropriate in cases where such organisms to be transferred are intended for subsequent release into the environment (such as in field trials) or are intended to be placed on the market, unless the receiving country has indicated, based on the familiarity or the characteristics of the organisms with novel traits, that no advance informed agreement is required.
• Contained use of certain organisms with novel traits on an industrial scale would in some cases use some organisms in such quantities that they may have adverse effect on human health and the environment if they are released by routine or accident. Transfer of such organisms with novel traits could for these reasons be covered by this advance informed agreement procedure.

47. Examples of the information to be supplied, at the request of the receiving country, prior to the intended transfer of organisms with novel traits in these cases would include:

• name and address of exporting user;
• name and address of receiving user;
• origin, name and taxonomic status of recipient organism;
• description of traits introduced or modified and characteristics of the organism;
• summary of the assessment of risks to human health and the environment;
• intended dates of transfer;
• number of organisms to be transferred or volume of culture and physical form;
• any relevant requirements to ensure safe handling, storage, subsequent transport and use;
• methods for safe disposal and suitable procedures in case of accidents;
• intended use of the organism;
• information on relevant previous releases.

48. Recognizing that some organisms with novel traits will be traded internationally as commodities, there is a limitation in the extent to which information can be provided to an importer about the presence of organisms with novel traits in that commodity. Implementation of the guidelines would, however, assist focal points in obtaining knowledge of the types of traits that have been approved in exporting countries.

49. When information is supplied before transfer, the appropriate focal point in the receiving country should advise the person or organization intending to transfer the organisms with novel traits of the specific information required. After making a decision about the transfer, the appropriate focal point in the receiving country should indicate to the person or organization transferring such organisms and the intended recipient any conditions that might be imposed on the transfer and subsequent use.

50. National focal points should indicate to other focal points and to any international register or database created for this purpose their particular information requirements for cases in which advance informed agreement applies.

51. National focal points approached by other national focal points, authorities/national institutional mechanisms or international bodies for information about organisms with novel traits and their uses, or for advice, are encouraged to provide as full a response as possible. Regional groups are encouraged to make arrangements for routine reciprocal exchanges of information about current activities involving the use of organisms with novel traits. Exchanges can be arranged in a variety of ways, such as between different regional groups, on either a regular or an ad hoc basis. National databases may be useful to provide information to other national databases or focal points.

52. In order to maintain safety levels during transport and transit, organisms with novel traits should be packed and labelled adequately. Packaging and labelling requirements should be commensurate with the level of risk involved. In order to maintain safety during transit and transport, existing international recommendations, agreements and conventions on transport should be taken into account.