Draft Report on a study tour and meeting of the
National Coordinators
of the
UNEP-GEF projects on Implementation of National Biosafety frameworks
19 - 30 January 2004.
Introduction
In November 2000, the GEF Council approved the GEF Initial Strategy on Biosafety, which aims to support countries to prepare for the coming into force of the Cartagena Protocol on Biosafety. Part of the GEF Strategy is the UNEP-GEF Project on Development of National Biosafety Frameworks, which started in June 2001. From November 2001, the GEF Council approved 12 demonstration projects to support countries with the implementation of their national biosafety frameworks. Two of those projects are coordinated by the World Bank, two by UNDP and eight by UNEP.
The UNEP-GEF demonstration projects on Implementation of National Biosafety Frameworks are carried out in Bulgaria, Cameroon, China, Cuba, Kenya, Namibia, Poland and Uganda. These projects last on average 3 years and the budgets range between 500,000 USD and 1,000,000 USD. Details about these projects can be found on the UNEP-GEF Biosafety web site ( under ‘Implementation Projects’.
As part of these projects a meeting of the national coordinators of the UNEP-GEF Projects on Implementation of National Biosafety Frameworks and their colleagues was held from 26 – 30 January 2004. Preceding that week of training, a study tour was made through a number of countries in Europe where biosafety frameworks have been in place for many years. The study tour started on 19 January and ended on 23rd of January.
The objective of the study tour and meeting were:
Give insight into the day to day practice of national biosafety frameworks by exchanging ideas, updates and experiences on the projects,
Aid the projects forward by providing direct one to one expert assistance on a number of topics for which National Coordinators requested assistance, such is biosafety policies, regulatory regimes for biosafety, implementing regulations and complementing guidelines, administrative processing of requests, public information, public participation and the BCH.
Assist the National coordinators to comply with the formalities of the projects such as finalizing the operational and financial reporting.
The study tour and meeting were also attended by observers from Egypt, Mauritius, Mexico, Tunisia and a number of international organisations.
During the study tour, presentations were also given by the Syngenta Foundation, The World Conservation Union - IUCN, the Dutch Consumer and Biotechnology Foundation, and the National Institute of Agronomical Research (INRA) in France.
At the closure of the meeting, there was consensus among the participants that this type of meetings are very useful and should be repeated as an annual event in the context of the UNEP-GEF Projects on Implementation of National Biosafety Frameworks.
The participants expressed their sincere gratitude to the Governments and organisations that hosted them during the study tour. They were particularly grateful for the presentations during the study tour to the Biosafety offices in Switzerland, Germany, the Netherlands, Belgium and France as well as for the briefings presented by the Sygenta Foundation, IUCN, the Dutch Consumer and Biotechnology Foundation and the French Research Institute INRA.
The participants also expressed their warm appreciation to the governments and organizations that made their experts available as resource persons for the meeting of the national coordinators from 26 – 30 January 2004.
This document is a summary report of the study tour and the meeting of the national coordinators. This report is not a formal document, but rather aims to offer reminder to the participants as well as to give others a flavour of this type of study tours and meetings.
This report was prepared by Sharon Oseku, an intern with the UNEP-GEF Implementation Team, in collaboration with Nelly Opiyo and with the support of several participants.
In the interest of brevity, this report only contains a summary of the main points of presentations given. The actual presentations are available on under ‘documents and links’.
This report contains two parts and an annex:
Part 1: Report of the study tour (19-23 January 2004)
Part 2: Report of the meeting (26 – 30 January 2004)
Annex: List of participants.
Part 1 – Report of the study tour
(19 – 23 January 2004).
19th January 2004 – Switzerland
Swiss Agency for Environment, Forests and Landscape (SAEFL).
The participants were welcomed by Philippe Roch, Director of SAEFL, who underlined the importance of good biosafety regulations and of international information exchange.
Biotechnology and Biosafety in Switzerland – Hans Hosbach (SAEFL)
Mr. Hans Hosbach, head of the Biotechnology Unit at SAEFL, explained that the three Federal laws on gene technology, epidemics and protection for the environment are supported by ordinances for containment, releases, accidents, transboundary movements, ethics and expert committees.
Three Competent authorities are responsible for authorizations, Federal office of Public health, Swiss Agency for the Environment Forests and landscapes, Federal office for Agriculture and Federal veterinary. Most of the GMO activity in Switzerland is for contained use
Day to day practice in implementation of regulation for contained use - Patrick Krahenbuhl (SAEFL)
Notifications are addressed to the Federal Coordination of Biotech, which is the competent authority. The request is registered in a database and immediately published on the Internet for all interested publics to view and scrutinize. The dossier is also passed on to the ministries depending on the activity for advise, after the decision has been taken, its passed on to the Federal coordination for Biotech which announces the final decision to the applicant.
Day to day practice in implementation of environmental release regulations. Andrea Raps – (SAEFL)
The Swiss Agency for Environment Forests and Landscape (SAEFL) is the Competent Authority for notifications on release of GMOs into the environment. SAEFL consults the Swiss Expert committee for Biosafety, Swiss Ethics committee and the Cantonal competent authority of the area in which the release is intended, before a decision is made.
Risk assessment: The biosafety assessments are based on the extent of potential damage that can be caused by a GMOs, which determines the measures put in place.
Risk Management: Field inspections are carried out during crucial times e.g. planting, harvesting and flowering by a -member committee made up of representatives from SAEFL, the Canton (region) competent authority, experts in agronomy and ecology
Commercialization: Different competent authorities participate and are involved in the decision making process on GMOs for commercialization depending on if the organisms are for food, feed, animals.
Communication and information: All information about the request for a release is published in the Federal gazette and on the Internet. Whole forms are published and only confidential information is excluded. Decisions are also published in the gazette, Swiss Biosafety clearinghouse (BCH) and through press releases.
The Role of experts - Karoline Dorsch (Swiss Expert Committee for Biosafety)
The Swiss Expert committee for Biosafety is a permanent independent advisory Committee which was set up to protect the Swiss environment and its people from the negative impacts of biotechnology and the gene technology sector. The committee advises state agencies and other organizations involved in biosafety, on new legislation and guidelines, notifications for field releases and placing on the market of GMOs.
The committee is made up of representatives from universities, economy, agriculture and forestry, environmental groups and the consumer groups, experts on biology and medicine. It meets 6-5 times a year and publishes an annual report that is distributed to all stakeholders including the press. The reports are also published on the Internet site for public information. The presentation detailed the issues on which the committee provides advise, the Federal agencies, the composition of the committee and how it works.
Swiss Ethics committee on Non-Human Gene Technology - Ariane Willemsen (Swiss Ethics committee)
The Ethics committee is an independent advisory committee appointed by mandate of the Federal council under the gene technology law passed in April 1998. It advises the government during the process of legislation by evaluating different ethical interests and addressing the moral and ethical implications of new developments of biotechnology.
The presentation detailed the importance of an ethics committee on biotechnology, its composition and how it works with both the government and public.
Implementation of the Cartagena Protocol - Francois Pythoud (SAEFL)
Switzerland ratified the Protocol on March 26th and it entered into force in September 2003. Importation of GMOs is currently regulated by a national framework and not AIA. A new regulation Cartegena Ordinance will cover existing gaps like a national focal point, participation in the Biosafety clearing house by providing information and all regulations pertaining to intentional and unintentional movement of GMO.
Following this introduction, Francois Pythoud also provided, on request of the participants, some insight in the workings of the Swiss Referendum System.
Summary of answers to questions
-Research applications are addressed directly to a competent authority, depending on the use for either contained use or field releases.
-Non-GMO farmers are given priority over GMO farmers. A GMO farmer has to ensure that no damage occurs to the crop of the non-GMO farmers.
-Appeals to decisions are addressed directly to the Federal offices that make the decision and not to the coordination agencies.
-The waiting period for approval in Switzerland for contained use is approximately 45 days
- Advisory committee members are selected from among stakeholders, and approved by the Federal council.
Syngenta and the Syngenta Foundation (Basel, Switzerland)
Vivian Anthony of Syngenta gave a brief presentation on how Syngenta works actively with national competent authorities to ensure compliance with the biosafety requirements of countries. She expressed the hope that this tour could would provide the participants not only with an insight into the regulatory structures of the European countries, but would also strengthen their networks.
In the discussion following the presentation, Dr Anthony confirmed that Syngenta is certainly willing to make ‘real life’ dossiers available for training exercises, provided requests are not made at the last minute.
Mrs. Theresa St. Peter of the Sygenta Foundation provided an overview of capacity building work of the Foundation in developing countries. Two cases were presented as examples of the type of approach the Foundation takes in these projects. One example was a project on insect resistant maize in Kenya and a second example was a project on soil conservation in Eritrea.
20 January 2004 – Germany
Federal Ministry for Health and Social Security (BMGS), Division 125 - Genetic Engineering, Biotechnology, Novel Food (Bonn, Germany)
The participants were welcomed by Mr. Arnold Schreiber (BMGS), who provided a brief history of the German biosafety legislation.
Overview of the European and German Legal Framework on biosafety, including policy issues - Gernot Schubert (BMGS).
Germany complies with the EU directives on regulations concerning contained use, deliberate release and placing on the market. Under the German Legal framework there exists a law on genetic engineering and ordinances that address risk assessment, safety measures, notification procedures, record keeping and public participation.
The Ministry of Consumer protection and Agriculture is in charge of issues on genetically modified organisms. Decision-making is based on scientific analysis of risks to the environment and human health.
The Länder (“states” in the German federal structure ) make decisions on contained use while deliberate release and placing on the market fall under the Federal system.
The presentation detailed the biotechnology products covered under contained and field releases, the issue of liability, traceability, central ideas governing regulation, history of tools and competences that handle GMO, and the structure of the German Government dealing with GMOs.
Summary of answers to Questions raised
-The German government does not have a strict liability policy in place.
-A list of products containing GMOs is available on the EU web sites.
-For purposes of traceability, a unique identifier is to be introduced in a new EU regulation.
Implementation of the Cartagena protocol in Germany and German Capacity building activities. Albrecht Schad (BMGS)
The provisions of the Cartagena protocol are fulfilled under EU legislation.
Germany participates in the Biosafety Clearing House (BCH) by providing information on the activities of biotechnology. Sanctions for those who do not comply with the regulations and laws are in the process of being drawn up and will be published in a journal in May 2004 .
Capacity building – Albrecht Schad
Germany has a number of initiatives that address capacity building on policy making, institutional building, and training of decision makers, including initiatives in China and in the African Union.
Under the EU twinning projects, Germany is involved in a project to assist Poland establish a legal and legislative framework on biosafety. Other aspects are legal review, decision-making procedure, inspections, accreditation of laboratories, establishing electronic information systems and public information. This project works closely with the UNEP-GEF project.
Decision Making on Deliberate release - Ulrich Ehlers (RKI/BVL Berlin)
Deliberate releases and placing on the market
Regulated under the EU directives 1829/2003 .
Deliberate releases and placing on the market have until recently been authorized by the Robert Koch Institute (Berlin), but this authority will be taken over by the Federal office for Consumer Protection and Food Safety.
The Robert Koch Institute is the regulatory authority on biotechnology and works in consultation with Federal Environmental Agency for Nature Protection and the Federal Biological Research centre for Agriculture and Forestry when making decisions on deliberate releases.
The Central Advisory Committee for Biological Safety (ZKBS) examines, assesses and recommends on the safety classification of GMO. The committee is composed of experts with experience in areas such as microbiology, cell biology, virology, genetics, and ecology and safety technology.
The Federal states (Länder) are also consulted in the decision making process.
Inspections
In Germany the different Federal States are responsible for inspection of field trials within each of the Länder.
Risk Assessment
A risk assessment is done based on the expected changes to plants caused by the introduced genes, ability of the transgenic plants to persist or establish in the environment disposal of plant material after the end of the release, transfer of the introduced genes to other plants via pollen transfer.
Public participation,
Decisions on notifications are published in the newspapers and on the website and the publics are called upon to participate and comment within a given time frame.
Answers to questions raised.
-Once an approval for field trials has been made in one Länder (State), the process for carrying out a trial in other Länder in Germany is not difficult.
-Public participation about field trails is limited to newspapers and websites where information on decisions about risk assessment reports is published.
Decision making on contained use and coordination among the Länder authorities. Dieter Heublein (State Environment Ministry, Bayern),
Each of the Länder has a Competent Authority that receives a notification and seeks the advise of the Commission on Biological Safety depending on the class of GMO before a decision is made. An emergency risk management plan is also developed depending on the risk potential. However there is no emergency plan on risk assessment, because so far no organisms that can cause harm outside the laboratory have been approved.
Inspections in Germany - Andreas Friemann (State Environmental Office, Cologne)
The inspection process differs from each Länder. There is an inspectorate located in each local administrative unit .The frequency of the inspections is once every 2-5 years depending on the level of bioactivity. The inspectors raise questions related to compliance to conditions and regulations as stipulated in the permit, on safety measures, correct documentation of GMOs and risk assessment. Sampling is used to verify and identify the safety measures. Inspection of deliberate release is done 3 times per planting season. Most violations identified relate to poor labor protection, and improper documentation of GMO.
Summary of answers to questions raised.
-A checklist is available on what needs to be inspected.
-When a violation is discovered, a written document by the inspector is sent to the competent authority detailing and describing the violations. A period of 6 weeks is given within which the offender has to comply with the regulations and an inspection is carried out to prove if the offender has effected compliance to the regulations.
-A scientist and 2 administrative personal experienced in GMO safety measures work at the inspectorate
-The inspection covers both universities and companies.
The World Conservation Union IUCN) – Bonn, Germany.
Tomme Young of IUCN provided an overview of the activities of the IUCN. The IUCN is an organization that, among others, provides guidance to understanding international agreements.
Francoise Burhenne of IUCN introduced the IUCN Guide to the Cartagena Protocol, which aims to be a document of reference for questions about the history, actual meaning and relations between the provisions of the protocol as well as other international agreements. She described the participatory process that was followed to develop the Guide.
The Guide is available in English, French, Russian and Spanish The participants received a copy of the Guide in the language of their preference.
21 January 2004 - The Netherlands .
The Netherlands Institute for Public Health and the Environment (RIVM, Bilthoven),
Introduction to handling requests for permits in the Netherlands - Birgit Loos (GMO Office)
The presentation provided an overview of the authorities involved in regulating GMOs in the Netherlands, describing the role played by each of the authorities, the legislation and the facilities needed.